Pfizer

Immune system & inflammation symptom reports

Female, 40 - 59 years

Age Reported Symptoms Notes
40 2020-12-31 lymph node pain, lymph node swelling No adverse event, just side effects: Sore arm on day 1, within 24 hours low grade fever 100.2F, ache... Read more
No adverse event, just side effects: Sore arm on day 1, within 24 hours low grade fever 100.2F, aches, neck lymph node soreness/slight swelling, fatigue
40 2020-12-31 lymph node swelling Swollen lymph nodes in neck, arm, and chest. Sore Throat, fatigue, headache. Lymph nodes swollen on ... Read more
Swollen lymph nodes in neck, arm, and chest. Sore Throat, fatigue, headache. Lymph nodes swollen on right side after one week of injection. Bilateral swelling of lymph nodes by day nine.
40 2021-01-02 lymph node swelling, lymph node pain Axilla lymph node swelling with tenderness and soreness 6 days post vaccine. No other symptoms. Ini... Read more
Axilla lymph node swelling with tenderness and soreness 6 days post vaccine. No other symptoms. Initial symptoms after receiving the covid vaccine was slight numbness and tingling of left arm where injection was. This resolved within the first hour. However, did have some left neck soreness and ache, as well as injection site soreness in left arm for three days
40 2021-01-03 axillary mass I got my left arm pit, lump on it, I have bigger than 1 cm 2 lumps, hidradenitis/Pain under my arm; ... Read more
I got my left arm pit, lump on it, I have bigger than 1 cm 2 lumps, hidradenitis/Pain under my arm; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Mastitis; I got Myalgia all over the body, especially on my shoulders and back; I had chills but my temperature was normal; This is a spontaneous report from a contactable physician (patient herself). This physician reported information for herself (mother) and baby. This is the mother case. A 40-year-old female patient received her first dose of bnt162b2 (BNT162B2, also reported as Pfizer Covid-19 Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 20Dec2020 18:30 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient informed that she got in her left shoulder and left arm pit, lump on it. It was bigger than 1 cm 2 lumps, hidradenitis under her pits arm same size on 21Dec2020. She also reported that she was nursing mom to her self-kid which is 16 months old. She had Mastitis right now (20Dec2020) and informed that she hadn't it her life before. She got her vaccine on Sunday (20Dec2020) in night. She started to have pain under her arm on monday afternoon (21Dec2020) and then since yesterday (20Dec2020) she had mastitis. The mastitis in the right side, lump and the in the left side, which was the site of the vaccine. She never got a fever but got myalgia all over the body, especially on her shoulders and back and also she had chills but her temperature was normal. The outcome of events was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event mastitis with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520371 Fetal case
40 2021-01-03 bursitis Patient immediate burning in her shoulder. Puncture site found to be too high for deltoid. Contacted... Read more
Patient immediate burning in her shoulder. Puncture site found to be too high for deltoid. Contacted Pfizer and IM/ID physician. Will re vaccinate in 5 days. Arm very painful, lump under acromion process. Feels like bursitis.
40 2021-01-03 peripheral swelling Toe went numb on right foot and next morning had a lot of swelling and cert painful under the foot. ... Read more
Toe went numb on right foot and next morning had a lot of swelling and cert painful under the foot. Whole top of foot and toe was really swollen and a lot bigger than the other couldnt walk or put pressure on my foot. Have been home unable to work since december 30th
40 2021-01-04 swelling, swelling, swelling face Angioedema; This is a spontaneous report from a contactable Other Health Professional (patient). A 4... Read more
Angioedema; This is a spontaneous report from a contactable Other Health Professional (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL1284, intramuscular in the right arm (also reported as right shoulder), first dose on 22Dec2020 00:30 at a single dose for Covid-19 immunization. The patient's relevant medical history included severe reaction to some animal dander and pollen, severe reactions to poison oak, possible drug induced reactions (unspecified) post C-section, mild rash with influenza vaccine this year (2020) (with no other hx of adverse reaction to a vaccine); had allergies to pollen, mold, some animals. The patient previously took influenza vaccine (split virion, inactivated) and experienced rash. The patient had no covid prior vaccination nor was she tested post vaccination. Adverse event reported was angioedema on 24Dec2020 with outcome of recovering. Systems started appearing on 23Dec2020 evening with slight rash and fluid collection under right eye. Developed more rash on 24Dec2020. In the evening to early morning of 25Dec2020, symptoms worsened significantly. Rapid swelling to face occurred. Swelling was concentrated around eyes and cheeks the most. Both right and left side of the face and neck were affected. However, the right side face had a more pronounced reaction. MD ordered oral prednisone and Benadryl as treatment plan. Also, ordered episode-pen for a worst case scenario. Symptoms have been improving under treatment but still persist some. The events were reported as non-serious. The adverse event start date was 24Dec2020 (as reported). The event resulted in doctor or other healthcare professional office/clinic visit.; Sender's Comments: There is a reasonable possibility that the event angioedema was related to BNT162b2 based on known drug safety profile and temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
40 2021-01-04 lymph node swelling One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in s... Read more
One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in size)-same side as injection. It was painful and partially mobile. No other symptoms other than those of headache a few days prior mentioned below. I went to urgent care on 12/29 where CXR and soft tissue ultrasound were ordered. CXR normal. US 12/30 showed cluster of lymph nodes in that area. Lump appears to be smaller this week and not painful. Also, I developed a severe migraine on 12/26 (5d post vaccine). So severe that it was debilitating which is unusual for me. It lasted approximately 36 hours.
40 2021-01-05 swelling Top of Right shoulder has been very soar and painful. This is week 3 of symptoms. My range of motion... Read more
Top of Right shoulder has been very soar and painful. This is week 3 of symptoms. My range of motion is limited and I have swelling on the top of my shoulder as well. Can hear popping and clicking in my shoulder when I try to do range of motion as well.
40 2021-01-06 swelling Angioedema & UrticariaPruritus
40 2021-01-06 peripheral swelling Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at i... Read more
Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at injection site, and then swelling and tingling in left hand. and head ache. Symptoms didn't subside until day 3. Still have pain in left arm that radiates down to elbow. All other symptoms subsided.
40 2021-01-06 swelling face EE reports facial swelling with pressure and HA at 3:00 pm went to the ER at 6:00 pm
40 2021-01-06 swelling Localized swelling/redness/warmth/soreness that started on the day after vaccine. I thought it was j... Read more
Localized swelling/redness/warmth/soreness that started on the day after vaccine. I thought it was just a normal vaccine reaction because I have had those in the past. It seemed to get a little smaller and less red/warm in the next few days but then started to get more red and swollen in the past 24-48 hours. It has been a week since the vaccine. It is itching some now for the past 2 days as well.
40 2021-01-06 swelling After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flash... Read more
After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flashes and nausea, pain in left hip. Got really sleepy. Had problems with left hip, problem getting out of car very stiff. Couldn't stand on the left leg. Had stinging with every step. Burning sensation in the hip. Right arm started having nagging pain with tingling, took Tylenol. Tried to get out of bed, left hip felt like something was poking with fire. Saw bumps on hip, left back. Upper arm was still having tinge. Took Benadryl. Next morning woke up with lesions on left hip, some ruptured that felt like acid and then form a scab. The right arm started with the lesions. Went to urgent care. Dr. diagnosed patient with shingles. Patient questions the Shingles at her age. Pt was given Valtrex for the shingles.
40 2021-01-07 lymph node swelling The next day had headache and right axillary swelling and tender right axillary lymph nodes.
40 2021-01-07 swelling face Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Re... Read more
Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness
40 2021-01-07 swelling Pfizer-BioNTech COVID-19 Vaccine EUA Patient experienced tingling tongue, odd taste on her tongue a... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Patient experienced tingling tongue, odd taste on her tongue and neck swelling. Actions taken: Patient stated she had her own 50 mg of Benadryl with her and had taken it at 1305. She states she has other reactions to medications in the past and it feels the same way. Patient monitored, EMS called and care transferred. Patient was alert and oriented.
40 2021-01-08 lymph node swelling, lymph node pain Swollen and painful left infraclavicular lymph node 2 days after 2nd COVID vaccine
40 2021-01-08 lymph node swelling Swollen left tonsillar lymph node and left sore throat
40 2021-01-09 anaphylactic reaction Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice ... Read more
Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.
40 2021-01-09 lymph node swelling Woke up this morning with swollen, and extremely tender right armpit area. It is visually swollen co... Read more
Woke up this morning with swollen, and extremely tender right armpit area. It is visually swollen compared to the left and is very painful. I am under the assumption this is likely a swollen lymph node post second vaccination. I have taken ibuprofen in attempt to help with pain and inflammation but does not seem to be helping much at this time. I anticipate this will improve over time.
40 2021-01-09 swelling face I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I ... Read more
I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I started feeling tired and a couple hours after that I felt crummy and the chills started. Mine weren't nearly as bad as some others have experienced. I didn't sleep well that night and woke up with a mild headache and body aches. Approximately 10AM on Thursday I noticed I had swelling in my upper lip and later my jawline with slight numbness. My eyes started feeling puffy that evening, approximately 6:30pm, and the symptoms began to improve after taking a Benadryl around 7:15pm. The swelling and numbness didn't seem to move down towards my throat nor did I experience any difficulty breathing or swallowing. I sl
40 2021-01-10 lymph node swelling I had large red and hot welt. I had lip node enlargement. It lasted for a week.
40 2021-01-10 swelling face This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient r... Read more
This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.
40 2021-01-10 swelling The day after the injection she noticed swelling in her right axilla that is painful but no redness.... Read more
The day after the injection she noticed swelling in her right axilla that is painful but no redness. She also had one day of headache, chills and joint pain.
40 2021-01-10 swelling Patient states on 01/09/2021 had soreness to the injection site. Felt " discomfort but not pain" . ... Read more
Patient states on 01/09/2021 had soreness to the injection site. Felt " discomfort but not pain" . Described discomfort as constant. The next day on 01/10/2021 at about 8am, the discomfort started to radiate down to her left armpit area and left lateral breast area. Denied redness or fever but did state area was " swollen" . Stated affected areas felt " hard but it was probably because there was swelling". Patient states she had full range of motion to left arm, no numbness or tingling to left arm or hand. No complaints of shortness of breath , chest pain, or rash.
40 2021-01-11 lymph node swelling Lymphadenopathy supraclavicular nodes, left side; This is a spontaneous report from a contactable ph... Read more
Lymphadenopathy supraclavicular nodes, left side; This is a spontaneous report from a contactable physician. A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) via an unspecified route of administration in left arm on 18Dec2020 12:30 at single dose for covid-19 immunization. The vaccine was administered in a hospital. Medical history included Known allergies with Penicillin. The patient was not pregnant. The patient was not diagnosed with COVID-19prior to vaccination. There were no concomitant medications. On 21Dec2020, the patient experienced Lymphadenopathy supraclavicular nodes, left side starting day 3 post vaccine and persistent to current with outcome of recovering. There was no treatment reported for the event. The event was assessed as non-serious. The patient was not tested for COVID-19 post vaccination.
40 2021-01-11 lymph node swelling swelling to left arm with lymph nodes swelling; mild headaches, body ache lasting more than 48 hours... Read more
swelling to left arm with lymph nodes swelling; mild headaches, body ache lasting more than 48 hours left arm cellulitis on steroid and antibiotic
40 2021-01-11 swelling, lymphatic obstruction lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021... Read more
lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021 in the morning, worsened over the next 48 hours; swelling progressed to level that made resting arm against body too painful, lifting arm above level of shoulder too painful, lifting objects in left hand too painful, deep breathe caused pain in left chest and rib/flank area, swelling in chest area progressed across chest toward neck and covering clavicle. swelling continued to increase until 1/12/2021, the first day which swelling and pain has decreased.
40 2021-01-11 swelling Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expec... Read more
Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expected fatigue, muscle aches, headache, chills. however, she had also developed significant swelling in her left armpit and the swelling has spread into her left chest wall and down into her left ribs. It has also become painful. It?s very painful to lower her arm against her body, to raise her arm above her shoulder, to lift anything, even a bottle of water. It?s also painful to take a deep breathe right in the area on the left chest where the swelling is and into her ribs under her armpit. The area doesn?t seem to be significant red or warm. It is very tender to touch and the swollen area is firm. It has not responded to ice or NSAIDS. Her shoulder and arm do not seem to have any swelling."
40 2021-01-12 lymph node pain, lymph node swelling Severe lymphadenopathy. Lymph nodes on the left side across upper chest, clavicle, and left arm, an... Read more
Severe lymphadenopathy. Lymph nodes on the left side across upper chest, clavicle, and left arm, and left arm pit were swollen and painful.
40 2021-01-12 lymph node swelling, peripheral swelling ?Pfizer-BioNTech COVID-19 Vaccine EUA. My Left Leg (entire leg) was swollen & Numb) I received my va... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA. My Left Leg (entire leg) was swollen & Numb) I received my vaccine and when I arrived home about 1pm that day My leg felt odd. when walking, standing I felt an odd sensation in my left foot/lower calf area. I had body aches mild which progressed at night especially pain running down my left side of my body. The next morning I put on my clothes for work and my body still mild aches but the pant leg was tight especially around the calf. My My left foot was swollen as well as my shoe fit tighter. I also had a numbing sensation through the leg. I had an ache behind the calf and the heel of my foot as well as the left foot of my left foot. The swelling remained and I worried I might have a DVT. I called my primary care DR office and they said I should go to the ER. I called employee health at my job and they told me go to the ER. So on 12/29/2020 I went to the ER. The providers there also thought I had a DVT especially after examining my leg and recognizing the significant swelling. My US venous doppler showed negative for DVT however a significantly enlarged lymph node. As of today the swelling is much improved however still slight. The sensation in my left foot is still not the same as before. I have a numbness and tingling sensation that runs from my Left lateral calf down to the sole of my foot.
40 2021-01-12 lymph node swelling Left axillary lymphadenopathy, headache, muscle ache, fatigue.
40 2021-01-12 swollen extremities Starting the day after the injection she began experiencing pain and swelling in her armpit.
40 2021-01-13 anaphylactic reaction Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observatio... Read more
Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observation period after vaccine administration. A Rapid Response (RR) code for an anaphylactic reaction was activated. Vital signs were SPO2 100%, HR106 BPM and BP 150/100 mmHg. Patient received Epinephrine 0.3mg IM, Benadryl 50mg IV and Solucortef 200mg IV by RR code protocol. She was transfer to the ER. After transfer vital sings were 146/106 mmHg, HR 145 BPM and 120 BPM, RR 22, O2 sat 100% and 99%.
40 2021-01-13 lymph node pain, lymph node swelling LYMPH NODES SWOLLEN UNDER ARM UNDER ARM SORE AND TENDER TO TOUCH NO TREATMENT, 1 WEEK LATER CONTI... Read more
LYMPH NODES SWOLLEN UNDER ARM UNDER ARM SORE AND TENDER TO TOUCH NO TREATMENT, 1 WEEK LATER CONTINUES TO BE SORE BUT SWELLING AND PAIN HAS DECREASED DAY BY DAY
40 2021-01-13 lymph node swelling, lymph node pain Swollen lymph nodes in left armpit and tender to touch.
40 2021-01-13 lymph node swelling Patient describes gastro problems, body aches and headache, lymph nodes are swollen and slight naus... Read more
Patient describes gastro problems, body aches and headache, lymph nodes are swollen and slight nausea
40 2021-01-14 lymph node swelling, lymph node pain Swollen and painful lymph nodes under arms; Swollen and painful lymph nodes under arms; This is a sp... Read more
Swollen and painful lymph nodes under arms; Swollen and painful lymph nodes under arms; This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248; expiry date: unknown) via intramuscular route in the left arm, on 07Jan2021 at 14:00, at a single dose, for COVID-19 immunization. Relevant medical history included anxiety, depression, hypothyroid, and hypertension. The patient has no known allergies. Concomitant medications included levothyroxine, escitalopram, paracetamol (TYLENOL), ibuprofen, and marijuana. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685) intramuscular route in the left arm, on 18Dec2020 at 13:00, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 21:00, the patient experienced swollen and painful lymph nodes under arms. The patient did not receive treatment for the events. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
40 2021-01-14 lymph node swelling Lymphadenopathy; This is a spontaneous report from a contactable healthcare professional who reporte... Read more
Lymphadenopathy; This is a spontaneous report from a contactable healthcare professional who reported for herself, a 40-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: el0142) at the hospital, intramuscular in the left arm on 06Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical history included "COVID prior vaccination Yes" on an unspecified date. The patient was not pregnant at the time of reporting. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 with lot number: EK7530 at age 40 years, via intramuscular route in the left arm, on 16Dec2020 at 12:00 PM, Nasal Swab test result was positive on 28Dec2020. The patient experienced lymphadenopathy on 07Jan2021 at 19:00. The event was considered as non-serious. No treatment was received for the adverse event. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.
40 2021-01-15 swollen extremities, lymph node swelling 1/13/20 fever, cough, chills, headache, fatigue lasted only a few hours. 1/14/20 approximately 36 h... Read more
1/13/20 fever, cough, chills, headache, fatigue lasted only a few hours. 1/14/20 approximately 36 hours (8pm) I developed pain and swelling in my left armpit. I went to bed and woke up with the same swelling and pain. Checked in at Urgent Care 1/15/20 swelling started in glands in neck around mid day.
40 2021-01-17 peripheral swelling 102 F fever through 1 gram acetaminophen (104.6 prior to medication), extreme body aches and headach... Read more
102 F fever through 1 gram acetaminophen (104.6 prior to medication), extreme body aches and headache, overwhelming fatigie, and diapohretic x 2days. Swelling of arm from elbow to axilla during same. Unable to work during symptoms. Moderate fatigue, body aches, headache, and site tenderness persist to date of reporting.
40 2021-01-18 guillain-barre syndrome Patient developed symptoms of Guillain-Barre syndrome on January 15, 2021 and was admitted the Hospi... Read more
Patient developed symptoms of Guillain-Barre syndrome on January 15, 2021 and was admitted the Hospital. She was diagnosed and eventually required ICU level care and has been treated with plasmapheresis. She is currently still in the ICU but is stable.
40 2021-01-18 swollen extremities STARTED ON 1/15/2021 4PM WITH NUMBNESS, TINGLING RIGHT UPPER EXTREMITY, AXILLLARY EDEMA AND INDURATI... Read more
STARTED ON 1/15/2021 4PM WITH NUMBNESS, TINGLING RIGHT UPPER EXTREMITY, AXILLLARY EDEMA AND INDURATION WITH SEVERE PAIN AND ELEVATED TEMPERATURE IN AREA, DIFFICULTY WITH ADDUCTION OF ARM, PAIN RIGHT SHOULDER WITH SWELLEING AND RIGHT TORSO PAIN,
40 2021-01-18 peripheral swelling severe leg and foot pain/severe arm pain; difficulty lifting arm; history of mild arthritis foot/Had... Read more
severe leg and foot pain/severe arm pain; difficulty lifting arm; history of mild arthritis foot/Had Flare a week after first vaccine; Had flare a week after first vaccine with mild foot swelling; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ej1685), via an unspecified route of administration on 17Dec2020 at 08:00 AM on Right arm at single dose for COVID-19 immunization in hospital. Medical history included possible asthma, left foot post traumatic arthritis with multiple surgeries including precious allograft, meralgia paresthetica left side otherwise healthy (History of mild arthritis foot and ankle surgery). Known allergies was none. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had history of mild arthritis foot and ankle surgery, she had flare a week after first vaccine with mild foot swelling but severe leg and foot pain in Dec2020, severe arm pain about 2 hours after vaccine with difficulty lifting arm for 24 hours after vaccine on 17Dec2020. Took mefenamic acid (ADVIL) for pain. Elevated feet for swelling. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of event 'severe leg and foot pain/severe arm pain' included mefenamic acid (ADVIL), for event 'foot swelling' included Elevated feet; no treatment was received for the other events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
40 2021-01-19 lymph node pain, lymph node swelling Swollen lymph node in left armpit with pain radiating down arm; Swollen lymph node in left armpit wi... Read more
Swollen lymph node in left armpit with pain radiating down arm; Swollen lymph node in left armpit with pain radiating down arm; nerve pain in tips of right index and middle fingers intermittently and when touched; Swollen lymph node in left armpit with pain radiating down arm; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 08Jan2021 08:45 at single dose at left arm for COVID-19 immunization. Medical history included osteopenia, vitiligo, known allergies: Demerol and Vicodin. The patient's concomitant medication received in two weeks included Vitamins. The patient previously took the first dose of bnt162b2 intramuscularly on 18Dec2020 20:45 (lot number: EH9899) at single dose at right arm for COVID-19 immunization. Facility type vaccine was Hospital. No other vaccine received in four weeks. The patient experienced swollen lymph node in left armpit with pain radiating down arm; nerve pain in tips of right index and middle fingers intermittently and when touched on 09Jan2021 07:00. No treatment received for the events. No COVID prior vaccination. COVID test post vaccination: Nasal Swab Negative on 05Jan2021. The outcome of the events was not recovered.
40 2021-01-19 lymph node pain Left-sided tender supraclavicular lymph node; This is a spontaneous report from a contactable Physic... Read more
Left-sided tender supraclavicular lymph node; This is a spontaneous report from a contactable Physician(patient). This 40-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EK4176), intramuscular at left arm on 09Jan2021 09:15 at single dose for covid-19 immunisation. Medical history included Eosinophilic Esophagitis, chronic constipation, allergy to tree nuts. Concomitant medication included macrogol 3350 (MIRALAX). Patient previously received first dose BNT162B2 (Lot number: EH9899) intramuscular at left arm on 19Dec2020 14:30 at single dose for covid-19 immunisation. The patient experienced Left-sided tender supraclavicular lymph node developed the morning after 2nd dose of COVID vaccine on 10Jan2021 06:30 with outcome of recovering. No treatment was received. There was no other vaccine in four weeks, no covid prior vaccination, covid tested post vaccination. Event was non-serious.
40 2021-01-19 lymph node swelling, peripheral swelling Initial symptoms on the evening of dose were just really sore arm, swelling of lymph nodes in undera... Read more
Initial symptoms on the evening of dose were just really sore arm, swelling of lymph nodes in underarm and body aches. Overnight I was restless and unable to sleep well, body aches and hot and then chilled and cold. By morning my arm was so sore and swollen it was difficult to move it, continued with all over body aches, fatigue to the point of unable to sit up, no fever but alternated chills/cold and hot/sweat. I did take ibuprofen every 4-6 hours throughout the day. This is the same type of reaction I had to tetanus when a teen.
40 2021-01-19 lymph node swelling Fever, rigors, body aches, extreme joint pain, dizziness, swollen lymph nodes in the right arm pit, ... Read more
Fever, rigors, body aches, extreme joint pain, dizziness, swollen lymph nodes in the right arm pit, clavicle and neck.
40 2021-01-19 peripheral swelling Fatigue, Sore Throat, Runny Nose, General Malaise, Body aches, Swollen Arm
40 2021-01-19 swelling face, lymph node swelling swelling to left armpit, left eye, left cheeck and lips.
40 2021-01-19 swelling Rash, swelling, nausea, headache, diarrhea, muscle pain, fever, chills
40 2021-01-19 swelling Severe pain in left arm (still in pain 1/20), unable to move arms above head (lasted 5 days for both... Read more
Severe pain in left arm (still in pain 1/20), unable to move arms above head (lasted 5 days for both arms), Chest pain and squeezing sensation in chest and both arms (lasted 6 days), altered heart rate (lasted 2 days), internal swelling (was told this is what was causing the "squeezing" sensation)
40 2021-01-21 lymph node swelling 1/22 @ 15:00-low grade fever, chills, body aches, headache 1/23 @ 17:30-noticed swelling in left ar... Read more
1/22 @ 15:00-low grade fever, chills, body aches, headache 1/23 @ 17:30-noticed swelling in left armpit and Red circle around injection site
40 2021-01-21 lymph node swelling Swollen lymph node in armpit
40 2021-01-21 peripheral swelling Body ache headache stiff neck stomach pain nausea vomiting arm swelling
40 2021-01-23 lymph node swelling Pfizer vaccine given @ 0956. After vaccine administration, client drove her car to the recovery area... Read more
Pfizer vaccine given @ 0956. After vaccine administration, client drove her car to the recovery area and met with the nurse, to show her direction of where to wait for recovery. client informed her, "I think I'm having an allergic reaction." Nurse asked her to describe what symptoms she is having. Client stated that she had an itchy throat, she felt that she couldn't breathe, and her heart was racing. Nurse activated RRT. At 10:00, Nurse responded to scene with the Kit containing the AED, oxygen, and emergency medication. Vitals taken: P: 102, RR: 18, Manual BP: 120/80, Oxygen: 100% RA, no pain. Upon assessment, stethoscope used, clear lungs sounds, normal heart sounds. Client AAO x4, speaking in full sentences, no SOB noted. Skin color normal, capillary refill <3 seconds. Lip color normal. Nurse noted that client's lymph nodes were swollen. Throughout event, client spoke with no SOB and in clear sentences. EMS arrived to scene at 10:09 am. Vitals: HR: 99, 100% RA, 146/98. At this point, client is reporting feeling much better, head-to-toe assessment appears normal. She refused transport via ambulance to the hospital. EMS left scene at 10:20 am. Client was instructed to wait for 30 more minutes for monitoring. Client left scene at 10:30 am with client feeling better. Lymph nodes are no longer swollen, client continues to speak in full sentences with no SOB noted. Skin and lip color normal. Client AA0x4. Client instructed that if she is needing medical attention, feeling SOB, etc., to call 911 or go to the nearest hospital.
40 2021-01-24 lymph node swelling Right arm injection site pain/swelling/red circle. Right Axillary lymph node swelling in arm injecte... Read more
Right arm injection site pain/swelling/red circle. Right Axillary lymph node swelling in arm injected. Headache, tiredness, muscle pain, chills, fever- T max. 101.8, feeling unwell.
40 2021-01-24 swollen extremities, lymph node swelling Lymph Nodes under armpit extremely swollen and painful. Unable to lift arm completely without pain
40 2021-01-24 peripheral swelling Extreme fatigue body aches chills sore and swollen arm
40 2021-01-24 swelling Rash and Swelling on left side with Headache and fatigue
40 2021-01-25 lymph node pain, lymph node swelling swollen lymph nodes around left clavicle and close to armpit and neck, that happened 5 days after th... Read more
swollen lymph nodes around left clavicle and close to armpit and neck, that happened 5 days after the first dose of COVID vaccine and they are very painful; Swollen lymph nodes around left clavicle and close to armpit and neck; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in left arm on 17Dec2020 08:00 at single dose for COVID-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took oxycodone and experienced allergy. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Dec2020 07:00 PM, the patient experienced swollen lymph nodes around left clavicle and close to armpit and neck, that happened 5 days after the first dose of COVID vaccine and they are very painful. The outcome of the events was recovering. No treatment was given to the patient for the events.
40 2021-01-25 peripheral swelling On 1/20/2021, approximately 2.5 hours after my second dose, I had nausea with dry heaving and starte... Read more
On 1/20/2021, approximately 2.5 hours after my second dose, I had nausea with dry heaving and started having intense, crushing pain in my CTL back (with the worst of it being in my thoracic and lumbar areas). *The nausea and subsequent dry heaving subsided within 6-8 hours with prescribed anti nausea. *The back pain only intensified, with me finally calling my doctor who recommended contacting ONE Parkview. This back pain continues today (1/26/2021). On 1/21/2021, in the early hours of the morning, I woke to hives over my entire trunk, left arm (injection site), and left thigh. *This subsided in maybe 10 or so hours with antihistamines. On 1/23/2021, at approximately 1100, I felt heat in my left arm. This coincided with a heavy feeling in my left arm. When examined, I noted that my upper arm was slightly swollen, blotchy, and had a reddened rash approximately 4x4 inches. Minor itching. *The swelling subsided by 1/25/2021, but the heat and reddened rash continues today (1/26/2021).
40 2021-01-25 swelling face Itching to face and chest around 3 hours after administration. Facial swelling noted overnight.
40 2021-01-25 swelling Left axillary swelling; tachycardia; shortness of breath; fever; chills; muscle aches; joint pain; T... Read more
Left axillary swelling; tachycardia; shortness of breath; fever; chills; muscle aches; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 10Jan2021 18:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 20Dec2020 (04:00 PM) for Covid-19 immunization. Medical history included known allergies to latex, cinnamon, and nickel. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced left axillary swelling, tachycardia, shortness of breath, fever, chills, muscle aches, and joint pain on 10Jan2021 (19:00). The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 post vaccination.
40 2021-01-25 swelling On same day of vaccination of 2nd dose, patient developed tongue swelling and neck; joint aches
40 2021-01-26 anaphylactic reaction After receiving vaccine developed dizziness and hypotension, then developed itchiness in throat. EP... Read more
After receiving vaccine developed dizziness and hypotension, then developed itchiness in throat. EPI pen was administered and emergency response team called. She was transported to the Emergency Room for treatment. She was treated with steroids and antihistamines. Diagnosed with anaphylactic reaction. Discharged with EpiPen, albuterol inhaler prn, and steroid taper.
40 2021-01-26 lymph node pain, lymph node swelling Enlarged and painful lymph node in left armpit; Enlarged and painful lymph node in left armpit; This... Read more
Enlarged and painful lymph node in left armpit; Enlarged and painful lymph node in left armpit; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EC3246), via an unspecified route of administration at left arm on 12Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the first dose of BNT162B2 (Lot number: EK5730) at left arm for covid-19 immunization. The patient experienced enlarged and painful lymph node in left armpit on 13Jan2021 with outcome of not recovered. No treatment received for the adverse events. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.
40 2021-01-26 swelling Swelling with redness and low grade fever (topped at 100.4 degrees)
40 2021-01-27 lymph node swelling Went to hospital in middle of night when resting heart rate was 136/ woke up in middle of night with... Read more
Went to hospital in middle of night when resting heart rate was 136/ woke up in middle of night with racing heart/was 133; chills; fever; body aches; swollen axillary lymph nodes; rash on shoulder, armpit and back close to the vaccine site; bad headache; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (left arm) from 13Jan2021 10:45 to 13Jan2021 10:45 at a single dose for covid-19 immunization. Medical history included asthma and hypothyroidism. Concomitant medication included beclometasone dipropionate (QVAR) and levothyroxine. The patient also has allergies to Codeine and Azithromycin. The patient took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020. Information on the lot/batch number has been requested. It was reported that the patient went to the hospital (Emergency Room/Urgent Care) in the middle of the night when her resting heart rate was 136 on 13Jan2021. She had fever, chills, body aches. She woke up in the middle of the night with racing heart. Was 133 in the hospital, they gave her 2 liters of fluids which eventually brought it down to 105. They ran a lot of test and ruled out anything else. On Jan2021, they also found swollen axillary lymph nodes. It's now 48 hours later, still have a fever, HR finally is below 100, she now has a rash on her shoulder, armpit and back close to the vaccine site and she have a bad headache. The outcome of the event fever was not recovered while recovered with sequel on unspecified dates for the other events.
40 2021-01-27 swelling On 1/22, I noticed a painful red itchy bump on my left foot. Another bump appeared on my right inde... Read more
On 1/22, I noticed a painful red itchy bump on my left foot. Another bump appeared on my right index finger the day after, and then another bump appeared today 1/28 under my right arm. They are getting larger, more painful and swollen, itchier, and seem to be filled with white pus. The one on my left foot has burst.
40 2021-01-28 lymph node swelling My body turned cold then followed by hot flashes coughing with blood. Low fever muscle pain but I ha... Read more
My body turned cold then followed by hot flashes coughing with blood. Low fever muscle pain but I had bronchitis two weeks prior next day cough wheezing completely gone and my lungs feel great I can breathe again with no mucus I have swollen lymph nodes but not to bad little headache but overall feeling ok just tired and some dizziness at times.
40 2021-01-28 peripheral swelling fever 38.7, vomiting x2, chills, body ache, headache, swelling of left arm for the next three days.
40 2021-01-28 swelling face, peripheral swelling Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Too... Read more
Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Took Tylenol, fluids, Benadryl, and rest.
40 2021-01-28 swelling Delayed onset of mild pain, swelling, erythema, paroxysmal moderate to intense pruritus.
40 2021-01-30 lymph node swelling mild headache and moderate swollen lymph nodes
40 2021-01-31 lymph node inflammation, lymph node swelling left auxiliary Lymphadenopathy and lymphadenitis; left auxiliary Lymphadenopathy and lymphadenitis; ... Read more
left auxiliary Lymphadenopathy and lymphadenitis; left auxiliary Lymphadenopathy and lymphadenitis; eyelid swelling; left eye swelling; left eye swelling and tenderness; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 14Jan2021 07:30 at a single dose for COVID-19 immunization. Medical history included seizure, COVID prior to vaccination and penicillin allergy. Patient was not pregnant at the time of vaccination. Concomitant medication included levetiracetam (KEPPRA) and lacosamide (VIMPAT). No additional vaccines administered within 4 weeks before the vaccination. The patient previously took LAMICTAL and experienced allergy. The patient experienced Left auxiliary lympadenopathy and lymphadenitis, eyelid swelling, and left eye swelling and tenderness on 15Jan2021 15:00. Patient took BENADRYL as treatment for the events and was recovering. Patient had not been tested since the vaccination. Information on the lot/batch number has been requested.
40 2021-01-31 peripheral swelling Pain, swelling and large bump in left arm. Pain down in left hand.
40 2021-01-31 swelling face Systemic: Rash (other than injection site)-Medium; Systemic: Other- half face swollen several hours ... Read more
Systemic: Rash (other than injection site)-Medium; Systemic: Other- half face swollen several hours later; symptoms lasted 1 day.
40 2021-02-01 guillain-barre syndrome Guillain Barre Syndrome; the patient's tongue started to go numb; The initial case was missing the f... Read more
Guillain Barre Syndrome; the patient's tongue started to go numb; The initial case was missing the following minimum criteria: Unspecified adverse event. Upon receipt of follow-up information on 18Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from contactable consumers, sibling of the patient and his wife. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. There was no medical history, Family Medical History Relevant to adverse events or concomitant medications. There were no Prior Vaccinations within 4 weeks and no additional vaccines administered on same date of the Pfizer suspect. The sibling of the patient reported the patient had an adverse event after the vaccine that he later described as Guillain Barre. The patient was hospitalized after receiving the COVID vaccine on 08Jan2021. She was admitted to the hospital, the consumer (the sibling's wife) thought, on either 14-15Jan2021. She was not sure of the admitting diagnosis but patient was being treated for Guillain Barre Syndrome. Patient has had a spinal tap on an unspecified date, no results were known. The patient was very healthy, in general the consumer knew she had no typical comorbidities. The reason it was thought to be related was she was perfectly healthy prior and right after she got the vaccine, the patient's tongue started to go numb, that day or the day after (in Jan2021). The events required a visit to Emergency Room, but not to Physician Office. Weight was unknown but the patient was very fit, and BMI (Body mass index) had to be in the normal range. The outcome of the events was unknown.
40 2021-02-01 lymph node swelling, lymph node pain Right sided supraclavicular lymph node enlargement and pain; Right sided supraclavicular lymph node ... Read more
Right sided supraclavicular lymph node enlargement and pain; Right sided supraclavicular lymph node enlargement and pain; This is a spontaneous report from a contactable nurse reporting for herself. A 40-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EJI1686), intramuscular in right arm, on 29Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included celecoxib (CELEXA), vitamin d [vitamin d nos] (unknown manufacturer), post natal vitamin. No any other vaccine within 4 weeks prior to the COVID vaccine was administered. The patient previously took butorphanol tartrate (STADOL) and experienced drug hypersensitivity. The patient experienced right sided supraclavicular lymph node enlargement and pain on an unspecified date with outcome of recovering. No treatment was given. The patient has not been tested for COVID-19 since the vaccination.
40 2021-02-01 peripheral swelling Administration error. Vaccine given in the wrong route. Arm swelled up.
40 2021-02-01 peripheral swelling bilateral hand swelling, flushing of neck and face, feeling hot. Alert and oriented x4, epi-pen to l... Read more
bilateral hand swelling, flushing of neck and face, feeling hot. Alert and oriented x4, epi-pen to left thigh, Benadryl 50 mg PO, reduced hand swelling, T97.8 F BP 151/91 SpO2 99% P78. 911 was called, staff assessed pt, did not transport. Pt had friend transport to ER in private vehicle to seek higher level of care as a precaution.
40 2021-02-01 swelling face Approximately 25-30 minutes after receiving the vaccine, my lower jaw and face began to tingle and f... Read more
Approximately 25-30 minutes after receiving the vaccine, my lower jaw and face began to tingle and felt numb and swollen. A few minutes after that began, the back of my throat was scratchy. I took Benadryl 30 minutes after symptoms began and within 45 minutes all symptoms resolved. 7 hours following the Benadryl dosing, the symptoms returned. I took another dose of Benadryl. The symptoms resolved and did not return.
40 2021-02-02 swelling, peripheral swelling angioedema of face, feet and hands. severe headache started 30 mins after injection, noticed swelli... Read more
angioedema of face, feet and hands. severe headache started 30 mins after injection, noticed swelling of eyes 1 hour after injection. less than 12 hours later, full facial swelling, hands and feet. continued to worsen for the next 5 days. swelling started to slightly subside day 5. fever until day 4. vomit day 3. chills until day 4. severe headache until day 18.
40 2021-02-02 peripheral swelling, swelling face Covid 19 vaccination provided by patients work (unknown manufacturer) via phone visit pt reports sta... Read more
Covid 19 vaccination provided by patients work (unknown manufacturer) via phone visit pt reports starting Saturday positive swelling in face, hands and feet, reports improvement in swelling at this time. Positive full body aches, fever, significant fatigue and shortness of breath
40 2021-02-03 swelling face facial swelling; This is a spontaneous report from a contactable nurse (patient). A 40-year-old fema... Read more
facial swelling; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received second dose of bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration in left arm om 11Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included seasonal allergies and urinary incontinence from an unknown date and unknown if ongoing. Concomitant medication included cetirizine, atenolol (NORTELOL) and oxybutynin. The patient was previously vaccinated with first dose of BNT162B2 (lot number: EH9899) via unspecified route in right arm ,on 22Dec2020 09:30 AM, for COVID-19 immunization. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced facial swelling on 11Jan2021 18:00 treated with diphenyhydramine (self administered). The outcome of the event was recovered on unspecified date.
40 2021-02-03 swelling face Swollen face, eyes lids, nose and lips. Received the vaccine on 1-11-21. Experienced left arm numbne... Read more
Swollen face, eyes lids, nose and lips. Received the vaccine on 1-11-21. Experienced left arm numbness and pain on site. Numbness subsided and pain was minimal. Went to bed and work up around 6am to face, eyes, nose and lips swollen. Barely unable to open eyes. Immediately contacted employer employee health and contacted PCP. Appointment scheduled with PCP. PCP assessment completed. Recommended prednisone for swelling. Unable to take because of previous reaction. Recommended for Benadryl to be taken every 4-6 hrs and also Ibuprophen
40 2021-02-04 lymph node swelling Swollen axillary lymph node Swollen subclavical lymph nodes
40 2021-02-04 swelling face Shortly after the vaccination I was still having the abdominal distention so I called to see if I co... Read more
Shortly after the vaccination I was still having the abdominal distention so I called to see if I could defer the 2nd vaccine because I wasnt feeling well and still experiencing AE from the 1st dose. I was advised I still had to get the vaccine so I did and by 2:30pm I begin to have severe facial swelling causing asymmetrical shaping of my face, my head was hurting extremely bad, fatigued and felt really bad. I had to lay down because my head was hurting, felt like I had pressure on the top of my head, neck and back. The pain was so bad I was transported to the ER and was isolated d/t previous COVID infection and all while there the my body felt as if it was steady swelling. I was hurting so bad I couldnt stand to be touched. I was given another round of steroids. I was advised I had COVID pnemonia and was given IM decadron, IM regalin and a subQ injection of immatrex for the headaches and administered ibuprophen and tynenol for the headache as well. I was discharged with a prescription of regalin and decadron. The ER dr. states I shouldnt have taken the 2nd vaccine because I was still suffering from COVID-19. The abdominal distention had dissolved but the congestion just will not clear up even after 3 rounds of steroids. Asoumedrol was prescribed by my ENT but it didnt help either so I have a CT Scan scheduled for next week with my ENT and has not been able to return to work since the 1st dose 12/22. I have be retested for COVID-19 on both 1/15 and 1/25 and both results are still positive for COVID.
40 2021-02-07 lymph node inflammation CHILLS, FEVER 40 DEGREES CELSIUS, HEADACHE, ACUTE LEFT AXILLARY PAIN AND EDEMA, RIGHT AXILLARY PAIN... Read more
CHILLS, FEVER 40 DEGREES CELSIUS, HEADACHE, ACUTE LEFT AXILLARY PAIN AND EDEMA, RIGHT AXILLARY PAIN, GREY COMPLEXION, MALAISE, GENERALIZED JOINT PAIN. DIFFICULTY RAISING UPPER EXTREMITIES DUE TO PAIN AN MUSCLE WEAKNESS,
40 2021-02-08 lymph node swelling on the morning on 2/6/2021 at 6am, swollen lymph nodes under left arm, migraine, vomiting and diarrh... Read more
on the morning on 2/6/2021 at 6am, swollen lymph nodes under left arm, migraine, vomiting and diarrhea, fever 99.8. Did not feel well through 2/8/2021.
40 2021-02-09 lymph node swelling Swelling of lymph nodes in her armpit on the same side; This is a spontaneous report from a contacta... Read more
Swelling of lymph nodes in her armpit on the same side; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 20Jan2021 (at the age of 40-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not provided. Concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 (lot number EL1284) on 30Dec2020 for COVID-19 immunization.The patient reported swelling of lymph nodes in her armpit on the same side that she received BNT162B2 which she noticed yesterday around noon (as of 22Jan2020). She wanted to report, further asking if it was common and how long it would last. She noted that this event was not seen with the first dose and was unsure if this was normal or not. The patient took ibuprofen for treatment. The clinical outcome of swelling of lymph nodes in her armpit on the same side was reported as not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
40 2021-02-10 lymph node pain, lymph node swelling Beginning 2/2/2021 I developed swollen, painful lymph nodes under my right arm and near the right si... Read more
Beginning 2/2/2021 I developed swollen, painful lymph nodes under my right arm and near the right side of my clavicle. I had visible swelling surrounding my right armpit. I felt fatigued and unwell, like I was sick.
40 2021-02-10 lymph node swelling Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain... Read more
Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain; Right axillary lymph node swelling; Tiredness; Headache; Muscle pain; Chills; Fever; Feeling unwell; Received the first dose of vaccination on 21Dec2020/second dose on 22Jan2021; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the right arm on 22Jan2021 (16:00) at a single dose for COVID-19 immunization at the workplace clinic. Medical history included hypertension; obstructive sleep apnea; had used continuous positive airway pressure (CPAP); obesity; polycystic ovarian syndrome; and had COVID-19. Concomitant medications included spironolactone, ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), metformin, acacia senegal, ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium silicate, cellulose microcrystalline, colecalciferol, croscarmellose sodium, cyanocobalamin, dextrin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, gelatin, glucose, hypromellose, lecithin, macrogol, magnesium oxide, magnesium stearate, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, starch, thiamine mononitrate, titanium dioxide, zinc oxide (ONE-A-DAY WOMEN'S), vitamin D, echinacea, cranberry, melatonin and black elderberry. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported) intramuscularly on the right arm on 21Dec2020 (when the patient was 40 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 22Jan2021 (16:00), the patient had received the second dose of vaccination of BNT162B2 when the first dose was received on 21Dec2020. On 23Jan2021 (13:00), the patient had right arm injection site swelling, red circle and pain; right axillary lymph node swelling; tiredness; headache; muscle pain; chills; fever; and was feeling unwell. The patient did not receive any treatment for the reported events. The outcome of the events was recovering for 'right arm injection site swelling, red circle and pain', 'right axillary lymph node swelling', 'tiredness', 'headache', 'muscle pain', 'chills', 'fever' and 'feeling unwell'; and was unknown for 'received the second dose of vaccination of BNT162B2 when the first dose was received on 21Dec2020'. The patient had not been tested for COVID-19 since the vaccination.
40 2021-02-10 swelling face, peripheral swelling Swelling of hands, fingers; rash and redness on forearms/red rash; Face swollen; Very hot.; This is ... Read more
Swelling of hands, fingers; rash and redness on forearms/red rash; Face swollen; Very hot.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Feb2021 at 03:15 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included obesity from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin/clavulanic acid (AUGMENTIN) and dextropropoxyphene napsilate/paracetamol (DARVOCET); both from unknown dates to unknown dates for unknown indications and experienced allergy. On 02Feb2021 at 15:45, the patient experienced swelling of hands/fingers, rash and redness on forearms/red rash, face swollen, and very hot; all reported as serious of being life-threatening. The events required a visit to the urgent care (physician's office). The patient was treated with epinephrine (EPIPEN) and unspecified medications at the urgent care after emergency medical services were called. The clinical outcomes of swelling of hands/fingers, rash and redness on forearms/red rash, face swollen, and very hot were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
40 2021-02-10 swelling face Facial swelling; This is a spontaneous report from a contactable consumer (patient). A 40-year-old f... Read more
Facial swelling; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date was not reported), via an unspecified route of administration on 21Jan2021 at single for COVID-19 immunization. Medical history included ongoing rosacea. There were no concomitant medications. Patient reported that she had her first dose of the vaccine on Thursday (21Jan2021) and she experienced facial swelling on her right cheek. She got it that night and it still has not gone down. She went to the doctor yesterday and the dermatologist to ask them what she can do about it and they told her to report the side effects. The patient was advised by the doctor to try Zyrtec for a whole week and patient already took the first pill at the time of the report. The patient had not recovered from the event at the time of the report.
40 2021-02-12 swelling Injected arm started throbbing. Woke up out of sleep twice that night to take NSAIDS to try and make... Read more
Injected arm started throbbing. Woke up out of sleep twice that night to take NSAIDS to try and make it bearable. Still 3 weeks later not able to push or pull with arm, drive care, or lift with left arm-including taking off shirt, without pain. Able to pinpoint exact place injection was given and pain associated when pushing spot. Taking NSAIDS all day long to be able to move. Finally after 2 1/2 weeks made general physician appt because it is crazy how long and how bad my arm hurts. At that time still not able to lay on left arm or lift over head. Have been to chiropractor 3 time to help relieve shoulder/muscle pain.
40 2021-02-13 swelling face, peripheral swelling Swelling of hands and fingers. Forearms radshy. Face was red, swollen and rash, looked like I had a ... Read more
Swelling of hands and fingers. Forearms radshy. Face was red, swollen and rash, looked like I had a sunburn I was so red. I was very hot.
40 2021-02-14 peripheral swelling red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the w... Read more
red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient
40 2021-02-15 lymph node swelling Weakness and Pain in muscles and nerves in legs. Swollen lymph node in right arm pit.
40 2021-02-16 lymph node swelling Days 1-2 after injection: tightness and ache in chest, collar bones, and ribs. Day 3: rash in lef... Read more
Days 1-2 after injection: tightness and ache in chest, collar bones, and ribs. Day 3: rash in left armpit Day 4: rash grew, swollen lymph node in left armpit noticeable Day 5: swelling and rash receding, still notable
40 2021-02-16 swelling face In monitoring area shortly after vaccination, patient reported to EMS observation staff she was expe... Read more
In monitoring area shortly after vaccination, patient reported to EMS observation staff she was experiencing "lip tingling." In speaking with staff during assessment, patient's symptoms progressed to c/o lower lip swelling and trouble swallowing. Redness and swelling noted around mouth and nose. IM epinephrine administered at 18:08 and 911 called for transport to hospital.
40 2021-02-17 lymph node swelling Fever aux node swelling chills Narrative:
40 2021-02-17 swelling face, lymph node swelling, peripheral swelling had second dose of COVID vaccine on 1/8/2021, notes initially with rash and swelling of face which w... Read more
had second dose of COVID vaccine on 1/8/2021, notes initially with rash and swelling of face which went away when she got home. Since then, patient has had HA but noticed swelling to left shoulder on 1/9/21. neck: 3 cm x 3 cm left supraclavicular lymphadenopathy with tenderness to palpation give ibuprofen 600mg PO x1 and discharged with Ibuprofen
40 2021-02-17 swelling face WEDNESDAY: HA, BODY ACHE, FRIDAY: FACE SWOLLEN. HA. FRIDAY WENT TO ER. MONDAY: SEVERE HA, NAUSEA... Read more
WEDNESDAY: HA, BODY ACHE, FRIDAY: FACE SWOLLEN. HA. FRIDAY WENT TO ER. MONDAY: SEVERE HA, NAUSEA, SEVERE ACHES. WENT TO DR OFFICE.
40 2021-02-19 lymph node swelling Swollen lymph node in neck, same side as injection site, lasted 2/14/21-2/18/21.
40 2021-02-19 peripheral swelling Woke up at 3am with aches all over my body in joints especially, and a headache. Experienced dry mou... Read more
Woke up at 3am with aches all over my body in joints especially, and a headache. Experienced dry mouth. Hands appeared swollen. Felt chills and a possible low grade fever, later one had a cold swear and pain continues at 4pm on the day after the dose.
40 2021-02-21 lymph node swelling Lymphoid under left day swollen and bruised. 2 inches under vaccine site was swollen, red and hot to... Read more
Lymphoid under left day swollen and bruised. 2 inches under vaccine site was swollen, red and hot to touch. Now bruising down the arm to her elbow. Last Lymphoid behind her left knee was swollen and enlarged.
40 2021-02-21 peripheral swelling After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 da... Read more
After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 days. She also experienced numbness of her left hip and swelling of her wrist. She was seen by her PCP and they did not associate the condition with the vaccine. After her 2nd dose on 1/28 she had a slight cough for 3 day and swelling of the arm and leg. She went to urgent care on 2/19 due to swelling and pain of her arms and legs. She was prescribed gabapentin, and pain medications. Employee developed left sided facial pain paralyses and went to the ED on 2/21 diagnosed with Bells Palsy and given acyclovir, norco and she is taking antibiotics for an ear infection. Currently still symptomatic.
40 2021-02-22 swelling face swelling on the left side of my face; Bell's palsy/ left side can not function properly. I have litt... Read more
swelling on the left side of my face; Bell's palsy/ left side can not function properly. I have little eye, mouth and forehead movement; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982), via an unspecified route of administration (at the age of 40-years-old) on 26Jan2021 10:15 at a single dose in Left arm for COVID-19 immunization. Medical history was not applicable (N/A). The patient was not Pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced swelling on the left side of my face and Bell's palsy/ left side can not function properly. I have little eye, mouth and forehead movement on 05Feb2021 10:30. The patient reported, "I have swelling on the left side of my face as well as Bell's palsy. My left side cannot function properly. I have little eye, mouth and forehead movement." The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The outcome of the events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Therapeutic measures were taken as a result of the events which included anti-viral medication and a steroid. The events were assessed as serious (Seriousness criteria-Disabling/Incapacitating). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
40 2021-02-25 swelling face I received the first dose on 12/30/20 and the 2nd dose on 1/20/21. I started have an allergic react... Read more
I received the first dose on 12/30/20 and the 2nd dose on 1/20/21. I started have an allergic reaction after eating walnuts on 1/30/21. I have never had reactions to nuts before. I had swelling, itching and rash on my face. I took Benadryl and after 32 hours, my symptoms improved. I have since avoided tree nuts. I have also been having wrist and finger "tightness" in both hands since 2/10. and it seems to wax and wane. Both hands feel stiff. Prior to the vaccinations, I have had no health conditions. I have an appointment w/ my PCP later in the month.
40 2021-02-28 lymph node swelling Persistent swollen lymph nodes in neck region. Persistent pain, discomfort, burning sensation in lef... Read more
Persistent swollen lymph nodes in neck region. Persistent pain, discomfort, burning sensation in left arm and neck region
40 2021-02-28 neck mass Multiple nodules in the right side of the neck, around 1 cm; This is a spontaneous report from a con... Read more
Multiple nodules in the right side of the neck, around 1 cm; This is a spontaneous report from a contactable pharmacist (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 09Jan2021 (at the age of 40years) at single dose for Covid-19 immunization. The patient's medical history was not reported; no known allergies. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced multiple nodules in the right side of the neck, around 1 cm on 15Jan2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was unknown. Information on the batch/lot number has been requested.
40 2021-02-28 peripheral swelling Her hand is a purple color; Her skin feels like a BP cuff is on it; entire left arm is swollen and r... Read more
Her hand is a purple color; Her skin feels like a BP cuff is on it; entire left arm is swollen and red; entire left arm is swollen and red; Her entire left arm, which is the arm that received the vaccine is swollen and red. It feels like the circulation is being cut off; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL8982 and Expiration date: 31May2021), via an unspecified route of administration at the left arm on 21Jan2021 at a single dose for covid-19 immunization. The patient's has no medical history. There were no concomitant medications. On 22Jan2021, her entire left arm, which is the arm that received the vaccine is swollen and red. It feels like the circulation is being cut off. It hasn't been seeming to get better. The first time she noticed it was the morning after the vaccine. Her entire arm was swollen. She thought it would dissipate. At times it has kind of gotten better, but then the swelling keeps coming right back. Like right now her arm was uncomfortable in her coat. On an unspecified date, her hand was purple color. Her skin feels like a BP cuff was on it. She has not had treatment for it. The outcome of the events was not recovered.
40 2021-02-28 peripheral swelling patient experienced swelling of the arm and fainted. patient was provided 2 cold packs from local e... Read more
patient experienced swelling of the arm and fainted. patient was provided 2 cold packs from local emt. 1 cold pack for arm. 1 cold pack for head/neck. patient was also monitored for cardiac abnormalities. no heart abnormalities were found. patient was able to return to vehicle.
40 2021-02-28 swelling patient experience swollen neck, itching, and elevated heart rate. she was administered 1/2 iv dose ... Read more
patient experience swollen neck, itching, and elevated heart rate. she was administered 1/2 iv dose of benadryl by local emt. Symptoms resolved.
40 2021-03-02 lymph node swelling Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade feve... Read more
Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade fever on Saturday, upset stomach, headache, lowgrade fever on Sunday, Swollen lymph nodes, rash on chest/shoulders/upper back and chills Monday, Rash spread to torso, arms, legs and neck, eyes burned and left ear hurt, chills, fever was 104, resting hear rate was 120 bpm
40 2021-03-03 axillary mass Sore, painful and swelling aroubd injection site. Painful lump in right armpit.
40 2021-03-03 lymph node pain, lymph node swelling I developed a very bad migraine about 4 hours after getting the vaccine that lasted all night and th... Read more
I developed a very bad migraine about 4 hours after getting the vaccine that lasted all night and the next day my arm was very tender where I got the shot. The adverse side effect I'm most concerned about developed 2 days later. I noticed it hurt to turn my head and realized I had a lump on the right side of my neck sort of under my chin but a little to the right of that. It's making my throat hurt even though my throat itself is fine and the pain from this knot is radiating up to my right ear. I'm sure it's a swollen lymph node. I've had swollen lymph nodes before with strep throat but never have they hurt as much as this is and I've never had just one lymph node swell until now. I got the shot on a Saturday and this symptom began on Monday. I've been dealing with it for 3 days now, so if it's now gone in 2 more days I'll be going to my doctor for evaluation. I just wanted to report this and I was also wondering if this reaction has anything to do with the brain tumor surgery I had for an acoustic neuroma brain tumor and they put a metal plate in my head that my body had a bad reaction to causing hives, itching, and a lot of extra pain and irritation.
40 2021-03-03 oral herpes After 1st dose, had some hearing loss due to fullness in ears, took 2 weeks for symptoms to subside.... Read more
After 1st dose, had some hearing loss due to fullness in ears, took 2 weeks for symptoms to subside. Since 1st dose, have had 4 HSV1 cold sores come about. After 2nd dose experiencing severe heartburn. Also continue to have HSV1 cold sore outbreaks.
40 2021-03-03 swelling face Rash from latex: Rx steroid ointment for earlier unrelated rash, Benadryl Wine flush/congestion: no... Read more
Rash from latex: Rx steroid ointment for earlier unrelated rash, Benadryl Wine flush/congestion: nothing Face swelling/redness/shortness of breath: Benadryl
40 2021-03-03 swelling face Histamine reaction: red, hot sweaty cheeks that became a little puffy; slightly itchy lips; red splo... Read more
Histamine reaction: red, hot sweaty cheeks that became a little puffy; slightly itchy lips; red splotchy patches on parts of my legs, chest, feet (mostly toes), and hands (mostly fingers). Started with my cheeks within minutes of the shot, got worse over the next hour. It took about 4-5 hours to dissipate. But even the next day, I have been a little itchy.
40 2021-03-04 lymph node swelling, swelling At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating a... Read more
At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating and very anxious. She quickly became pale and fainted. At 0925 she was awoken using a cold pack to her face and chest. Her vital signs were taken and stable. She continued to feel anxious, her nausea went away. She still felt dizzy and her fingers were tingling, at approximately 0934 she felt it difficult to swallow and like something was "swollen/tight" in her throat. Lungs were clear, she was swallowing normally. At 0940 she felt her neck still "swollen", upon assessment her submandibular nodes were enlarged to palpation. Benadryl 25 mg orally x1 was given at 0945, vital signs remained stable. She began to feel better at approximately 10:00 am, she recovered and was able to ambulate. A co-worker took her home at 10:51 am.
40 2021-03-04 swelling face After getting the shot, I walked over to the observation area a few yards away. I sat down and my vi... Read more
After getting the shot, I walked over to the observation area a few yards away. I sat down and my vision went blurry and the room lights were too bright. I spoke with a dr about taking ibuprofen for my ankle, as I was told to only take Tylenol. The dr said that I was fine to take it. I didn?t want to ask about my vision because I was embarrassed and didn?t want to be stressing or panicking and that be the cause of my vision issues. But it didn?t subside so I checked with a nurse before leaving, about 15 mins after the vaccination and asked if I was ok and she said yes, that she only had 1 other person tell her about blurred vision. I walked to my car and the sun was so bright I had to shield my eyes. I got in the car and took my mask off. I looked in the mirror and my cheeks and chin were flushed but my skin was pale. My husband sat with me for 10 mins and then went in for his shot. At this point it had been a little over 30 mins since getting vaccinated. I FaceTimed my mom so I wouldn?t be alone. As we were talking she said my face was getting puffy and I was getting darker circles under my eyes. I got off of the phone with my mom and called my husband on FaceTime. I asked him to talk to the dr for me and let her see my face. She said my face was swollen and red and asked if I could breathe or felt like my throat was closing over or tongue was swollen. I told her no. Once again I was told I was ok and to take Benadryl. An hr or so after the 1st dose vaccination I was able to get Benadryl and Tylenol. In a 12hr period I took 2 doses of Benadryl and 2 doses of Tylenol. My face got better in 12-24hr but I still have blurred vision and light sensitivity.
40 2021-03-07 swelling face Within 5 min I had hives and facial swelling. I was given Benadryl and 20 min later I had body shak... Read more
Within 5 min I had hives and facial swelling. I was given Benadryl and 20 min later I had body shaking/tremors
40 2021-03-08 peripheral swelling Headache since about 15 minutes after injection. Injection site pain started about 10 minutes after ... Read more
Headache since about 15 minutes after injection. Injection site pain started about 10 minutes after injection and stopped after day 2. Tiredness started a few hours after injection and got better after day 4. Muscle pain and chills started the same day and stopped on day 4. Injection site swelling started on day 2 and went down on day 4. Injection site redness started as pink but is now purple. Nausea started within 10 minutes of injection but went away the same day. Feeling unwell started the same day of the injection and has been ongoing off and on since. My whole arm felt swollen on Saturday. The same day, I started noticing blood blisters on my fingertips on my left hand. More and more have shown up since then.
40 2021-03-09 lymph node pain, lymph node swelling The patient reports fever, chills, body aches, diarrhea, left axillary lymph node enlargement, and l... Read more
The patient reports fever, chills, body aches, diarrhea, left axillary lymph node enlargement, and left breast tenderness following first dose of Pfizer vaccine. Constitutional symptoms lasted less than 1 week and were managed conservatively. The left axillary lymph node and left breast remained painful and enlarged for approximately 1 month.
40 2021-03-09 white blood cell count increased High blood pressure, tachycardia, difficulty breathing air, mental confusion, dizziness, nausea, as... Read more
High blood pressure, tachycardia, difficulty breathing air, mental confusion, dizziness, nausea, asthenia, numbness arms hands and legs, couldn't move arms, flushing facial on neck and arms, hyporexia.. applied hydrocortisone and medication to reduce blood pressure.. I was hospitalized for 3 hours and they sent me home.. reoccurance 12 hours later but with greater intensity and I was hospitalized again.. I am the patient and I am a medical doctor..
40 2021-03-10 lymph node swelling Fever, swollen lymphnodes on right side of chest under armpit
40 2021-03-10 lymph node swelling Swollen arm pit lymph nodes swollen and painful
40 2021-03-11 lymph node pain Chills, fatigue, fever, extreme muscle aches, headache, loss of appetite, mild nausea, Extreme exha... Read more
Chills, fatigue, fever, extreme muscle aches, headache, loss of appetite, mild nausea, Extreme exhaustion, skin that's sensitive to the touch, bone aches, difficulty moving/walking/standing. Felt dehydrated. Started at 2:30am and didn?t go away until Sunday morning. Took Tylenol at 12 and 6pm, ibuprofen at 10pm. The following day my body hurt, headache, mild nausea. Still have pain in lymph node under vaccinated arm and arm muscle twitch. Mild dehydration.
40 2021-03-14 lymph node swelling Mild shoulder muscle soreness at site injection day of 2nd dose; next day, lymph node (underarm) was... Read more
Mild shoulder muscle soreness at site injection day of 2nd dose; next day, lymph node (underarm) was noticeably swollen to the size of a small orange - symptom began to subside by morning of 3/15/21.
40 2021-03-17 lymph node swelling, swelling BlurredVision, Dizziness, Myalgia, Arthralgia, Fever, Angioedema, INJECTION SITE PAIN, SWOLLEN GLA... Read more
BlurredVision, Dizziness, Myalgia, Arthralgia, Fever, Angioedema, INJECTION SITE PAIN, SWOLLEN GLANDS Narrative: Other Relevant History:
40 2021-03-17 peripheral swelling I received my second dose of the COVID vaccine on 3/5/21. The symptoms began on 3/7/21 with pain in ... Read more
I received my second dose of the COVID vaccine on 3/5/21. The symptoms began on 3/7/21 with pain in my upper left arm. The next following night, I was awakened by sharp pains from the top of my left arm to my fingers. Even the back of my left arm is swollen. It even traveled down my back. I went to urgent care on Sunday 3/9/21 to see what had happened. A CNP said it seems musculoskeletal and the pain radiated from the injection site. I've taken Tylenol, Ibuprofen, been prescribed muscle relaxers and steroids to numb the pain but it doesn't work. This is still occurring to this day.
40 2021-03-18 lymph node pain Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I wa... Read more
Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I was monitored for 30 minutes by the nurse and as the symptoms were not getting worse she suggested I drive home and take Benadryl. It was a 45 minute drive. Halfway home (about one hour after my shot) I started experiencing itching, swollen tongue, swollen lips. I took 62.5 mg of Children?s Benadryl and met up with my husband and he drove me to the ER, arriving at about 10;15. After being there about 15 minutes some of my symptoms started going away. At about 11 a rash appeared on my chest. The ER doctors gave me Pepcid 10 mg around 1130 or so. They just charge me and recommended I follow up with my allergy doctor.
40 2021-03-18 lymph node swelling Injection site pain, Swollen axillary gland Narriave:
40 2021-03-18 lymph node swelling large left supraclavicular lymphadenopathy
40 2021-03-18 peripheral swelling I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, t... Read more
I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, tongue, my mouth and throat felt itchy, the itching got so bad that i had hives in some places such as my forearm and legs and skin just felt like it was on fire, I had issues breathing and felt as though someone was sitting on my chest, i have been shortness of breath since and have trouble catching my breath.. This was all that same night. The next day I had the same issues adding the sore arm of the injection site and feeling very tired all day. the next day from there am I am feeling better but am still experiencing shortness of breath, I am using my inhaler, I am still itchy but not as severe as the first night or next day. The arm tenderness has gone unless you touch the injection site and am no longer feeling over tired.
40 2021-03-19 peripheral swelling, swelling face Received vaccine around 11:40am. Around 7pm same night on 3/19/21 noticed rash to tops of both feet,... Read more
Received vaccine around 11:40am. Around 7pm same night on 3/19/21 noticed rash to tops of both feet, with mild swelling and itching to feet and lower legs. Took 2 benadryl and went to sleep. Woke up this morning with facial swelling, eyes swollen shut. Took Claritin and states improved greatly. Reports itchiness in throat but denies difficulty breathing, throat swelling, chest pain or shortness of breath. Rash on feet/legs was gone when she woke up, still has itchy sensation to body but no rash. Patient reports improving symptoms at time of evaluation in Urgent Care, but would like to report side effect/reaction.
40 2021-03-20 peripheral swelling Arm swelled and and has tenderness week after covid Pfizer vaccine
40 2021-03-22 lymph node pain, lymph node swelling Severely painful and swollen lymph node near neck. Lasted for seven days.
40 2021-03-22 lymph node swelling 10 spontaneous nosebleeds (left nostril only) Muscle Weakness Nausea Dizziness Swollen Lymph Nodes (... Read more
10 spontaneous nosebleeds (left nostril only) Muscle Weakness Nausea Dizziness Swollen Lymph Nodes (only on left side of body)
40 2021-03-23 anaphylactic reaction Anaphylaxia, breathing trouble
40 2021-03-23 anaphylactic reaction 1:39 PM - Vaccine administered 1:40PM - Anaphylactic reaction began (difficulty breathing) 1:40PM - ... Read more
1:39 PM - Vaccine administered 1:40PM - Anaphylactic reaction began (difficulty breathing) 1:40PM - First dose epinephrine administered with patient supply 1:45PM - Second dose epinephrine administered with patient supply 1:50PM - Third dose epinephrine administered with patient supply, EMS arrived, nasal cannula oxygen started 1:55PM - Fourth (PARTIAL... EMS did not remove locking mechanism, not certain how much patient received) dose epinephrine administered with store supply by EMS 2:00PM - Transported by EMS to Emergency Dept.
40 2021-03-23 lymph node swelling Throat stated to felt tight, lightheaded. Pt had COVID November 2020. More swollen under chin area a... Read more
Throat stated to felt tight, lightheaded. Pt had COVID November 2020. More swollen under chin area and lymph nodes. Patient states her mouth feels dry.
40 2021-03-23 swelling face, lymph node swelling Swelling of face and lymph nodes in neck, fighting of throat.
40 2021-03-24 lymph node swelling, lymph node pain 03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve fo... Read more
03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve for back. 3:30-4:00 symptoms undeniable: itch on neck, face, trunk, lips tingle/swell, lump in throat. Hoarse. No hives. 4:00 Claritin 4:30 talk to Dr take vitals (Sp02 100%, heartbeat normal, BP 131/79, pulse 67, temp normal) 5:15 Benadryl 5:30 itch spreads to whole body, including legs 6:30 talk to Dr Symptoms steady now. 7:30 fall asleep from Benadryl 8:30 wake up for dinner 9:30 laying in bed, breathing becomes shallow. O2 and bpm still normal. 10:00 Talk to Dr. Advises ER if vitals outside of norm. Report to PCP in am. 11:00 breathing normalizes. Sp02 and bpm normal, BP 122/82, pulse 70. Aleve before bed. midnight-1:00 fall asleep 03.16.2021 7:20 Wake up. Water, Wellbutrin, Aleve. Read in bed about an hour until fall back asleep. 11:15 Wake up. Headache. Sp02, bpm, temp, normal. Stay in bed. 12:25 Send report to Dr. 12:30 Get out of bed for first time; coffee, bathroom. Back to bed. 1:10 Spoke with triage nurse. Concern is that lips are still swollen at almost 24 hours. Recommends urgent care for steroids if increased lip/face or respiratory symptoms. Can take Claritin an hour early. 2:30 Get out of bed and shower. Warm to wash, cool to rinse. Got dressed, moved around. Increased itching, skin mottled; still no hives. Aleve. 3:00 Claritin, call from Dr nurse. 3:30 Heat up late lunch, continue to move around the house, answer work questions. 4:30 Upticked symptoms not abating, still mottled skin, lips more swollen. Harder to swallow and dry cough starts, worse when talking. Take vitals: Sp02 and bpm normal, BP 107/83, pulse 73 5:00 Leave for urgent care; BP there 159/71, pulse 79, temp normal. No steroids. Referral to allergy/immunology. Prescription H2 inhibitor, switch to Zyrtec in am. 6:40 Pepcid. Back in bed. 11:30 Benadryl, Aleve. 12:40 Sp02, bpm normal 1:15 Fall asleep 03.17.2021 8:55 Wake up. Water, Wellbutrin, Aleve. 9:30 Sp02, bpm normal. Get up for Pepcid, Zyrtec, bathroom then back in bed. 11:20-11:40 Dozed off, woken up by heart symptoms. Palpitations, panic feeling. Sp02, bpm normal 12:45 Dr called. Allowed to switch back to Claritin tomorrow. Recommends Benadryl more often. Allergy: 504.842.6742 Dr 3:00 Aleve. BP 117/80 pulse 75 4:15 Benadryl 8:20 Hoarse again 9:20 Pepcid. Itching increasing as Benadryl wears off. 10:20 Benadryl 10:30 BP 103/77, pulse 73. Sp02, bpm normal, PI 2.5% 11:45 Aleve 12:00 itching increasing as move around/get ready for bed 1:15 Fall asleep 12.18.2021 6:30 Benadryl. Tired, itch still present (improving), headache. Fell back asleep 7:30. 8:55 Water, Wellbutrin, Aleve, Claritin, Pepcid. Fell back asleep until 11:30 11:45 Sp02, bpm normal, PI 8.0 2:00 Finished shower, didn't worsen itch. 2:45 Aleve 6:00 Been "on" for work about 4 hours. Exhausted. Nauseated. Verge of collapse. Most itching is face/scalp and clothing seams. Lips almost normal though. 8:00 Meds definitely wearing off; face/lips symptoms increasing again. 8:30 Benadryl. Throat symptoms. Swollen lymph nodes. 9:15 Pepcid. Slight cough returned. 10:30 BP 120/85, pulse 80 (was just moving around quickly), Aleve. Itching better, throat/lymph nodes painful 12:45 Benadryl. Ibuprofen. Neck muscles hurt too. 1:15-1:30 fall asleep 03.19.2021 9:00 Water, Wellbutrin, Aleve. Throat still swollen. Itch primarily face/head, back of thighs. 9:15 Pepcid, Claritin. Sp02 normal, bpm low (51-53 back in bed), PI 4.1 3:15 Aleve. Lump in throat still impacts swallowing. Eating makes me hoarse. Neck muscles hurt. 11:00 Pepcid 12:15:Benadryl, Aleve. BP 109/76, pulse 69 2:30 fall asleep 03.20.2021 10:00 Water, Wellbutrin, Aleve. Lips swollen again. 10:15 Pepcid, Claritin 11:25 Symptoms: itching better, mostly gone from body (remains on head). Headache. Throat/neck improved. Lips still swollen. Sp02, bpm normal. PI 10.2% 6:00 Aleve. Itching only head/face. Throat/neck still symptomatic. 11:30 Aleve, Pepcid. Sp02 normal, bpm 70s. 12:15 Benadryl 1:20 Throat sore but no lump. Lymph nodes returning to normal. Still some itch head/face/neck. 1:45-2:00 fall asleep 03.21.2021 7:00 Claritin, back to sleep 11:00 Aleve, Pepcid, Wellbutrin. 5:00 Aleve 11:10 Pepcid, Benadryl. Mild itching. No lump. Throat still slightly sore. BP 113/77, pulse 69 12:20 Aleve 1:15-1:30 fall asleep 03.22.2021 9:45 Water, Wellbutrin, Aleve, Claritin, Pepcid 5:50 Aleve 10:00 Pepcid 12:15 Aleve. Minimal, occasional itching. Lips almost normal. Sp02 normal, bpm 70s 03.23.2021 9:45 Water, Wellbutrin, Aleve, Claritin, last Pepcid
40 2021-03-25 lymph node swelling Felt slight swelling in left armpit exactly one week after the vaccine (3/25). On 3/26 swelling was ... Read more
Felt slight swelling in left armpit exactly one week after the vaccine (3/25). On 3/26 swelling was mildly painful and the place of original shot was red and slightly raised.
40 2021-03-25 lymph node swelling Fever of 101, swollen lymph nodule in armpit , body aches and stiffness of joints and limbs.
40 2021-03-27 peripheral swelling Knuckles in my left hand became swollen like someone who has had rheumatoid arthritis for years. My ... Read more
Knuckles in my left hand became swollen like someone who has had rheumatoid arthritis for years. My knuckles have never swollen before. It?s been 2 weeks and they are still swollen with large knots on the first joint near the tip of my pointer, middle and pinky fingers. My right hand is not affected at all.
40 2021-03-28 lymph node swelling, lymph node pain Two left side swollen lymph nodes by collar bone. They are about the size of a dime and are very te... Read more
Two left side swollen lymph nodes by collar bone. They are about the size of a dime and are very tender and sore.
40 2021-03-28 peripheral swelling Headache, nausea, chills, body aches, sore large swollen area in arm pit, sore arm
40 2021-03-30 lymph node swelling Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; t... Read more
Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; throat ache; ear ache; unable to get out of bed for 3 days; extremely swollen lymph nodes; This is a spontaneous report from a contactable Other Health Professional, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in the left arm on 30Jan2021 at 10:15 AM as a single dose for covid-19 immunisation. Medical history included allergies to sulfa antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (IBUPROFEN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EJ1686) via an unspecified route of administration, in the left arm on 08Jan2021 at 10:00 AM as a single dose for covid-19 immunisation. On 30Jan2021 at 12:00 PM the patient exepereinced fever for over 3 days, going up to 103F, extremely swollen lymph nodes, severe migraines, dizziness, brain fog, loss of apetite, ear and throat ache, unable to get out of bed for 3 days. No treatment was given to the events. The events were assessed as non-serious by the reporter. Outcome of the events were not recovered.
40 2021-03-30 peripheral swelling, anaphylactic shock Anaphylactic shock. Tongue, Hands and feet swelling. Hives all over body, skin felt like it was burn... Read more
Anaphylactic shock. Tongue, Hands and feet swelling. Hives all over body, skin felt like it was burning from itching so bad. Inside of mouth and throat itching. Chest felt like someone was sitting on it.
40 2021-03-31 lymph node swelling Within minutes of my injection I had a hot flushing of heat fill and stay in my chest and throat. T... Read more
Within minutes of my injection I had a hot flushing of heat fill and stay in my chest and throat. The sensation was similar to receiving contrast dye for something like a CT scan. I was given Benadryl and my vitals were checked. I stayed at the clinic for a total of an hour. The sensation was fully gone about 90min after injection. I never felt short of breath or struggled to breath. I am experiencing pretty standard flu like symptoms within 12-24hrs after my second dose. Biggest and perhaps strangest side effect I feel now is all the lymph nodes in my right armpit are swollen and very sore.
40 2021-04-01 anaphylactic reaction Signs/Symptoms: severe dyspnea, wheezing, anaphylaxis Treatment: Epi Pen (Left Anterior Thigh) and... Read more
Signs/Symptoms: severe dyspnea, wheezing, anaphylaxis Treatment: Epi Pen (Left Anterior Thigh) and EMT Called/Transported to Hospital Emergency Department.
40 2021-04-04 anaphylactic reaction Experienced brief, minor dizziness about 10 minutes after the shot. On my drive home about 15-20 min... Read more
Experienced brief, minor dizziness about 10 minutes after the shot. On my drive home about 15-20 min. after the shot, I experienced more severe symptoms of anaphylaxis. I was able to breathe but my airway was constricted and swollen. After arriving home, I called pharmacy but their pharmacists were out on lunch. My primary care doctor was closed (Good Friday). I waited until the pharmacist was back from lunch and they advised Benadryl (I took 50 g at 2pm) and to have someone with me for the next 24 hours. Symptoms improved some but by 5pm I still couldn't take a deep breath normally and was concerned about eating food. I went to the ER where they admitted me and administered Pepcid and dexamethasone at 6:22pm. After about an hour and a half, I felt better and was released. Once home, I ate food and that irritated my throat again so I kept an EpiPen nearby that evening just in case. The next morning I felt 100% with no side effects.
40 2021-04-04 swelling face Facial swelling at site of fillers Pain/tenderness in left armpit Pain/tenderness in left breast Hea... Read more
Facial swelling at site of fillers Pain/tenderness in left armpit Pain/tenderness in left breast Headache Neck pain
40 2021-04-05 lymph node swelling, swelling face About 90 minutes after the shot, my face swelled up and had hives. My left eye would not open all th... Read more
About 90 minutes after the shot, my face swelled up and had hives. My left eye would not open all the way. I had hives on my back, chest and both arms. I got the symptoms under control after 9 Benadryl pills. 2 days after the shot - my lymph nodes swelled up in my neck and on my left clavicle. I did not treat these. 3 days after the shot, out of nowhere, my left cheek swelled up and there were hives and my eye was half swollen shut. Symptoms were under control after 2 Benadryl pills. My lymph nodes remain slightly swollen, but not as severe as on Day 2.
40 2021-04-06 lymph node swelling Chills, muscle aches, fatigue, dizziness, swollen lymphnodes and headache
40 2021-04-06 lymph node swelling Fatigue Headache Swollen lymph nodes in right armpit Pain throughout arm down to fingertips
40 2021-04-06 swelling dose 1: fever chills headache for about 3 days , tylenol taken dose 2: no fever, no tylenol taken, ... Read more
dose 1: fever chills headache for about 3 days , tylenol taken dose 2: no fever, no tylenol taken, chills the first night, pain and swelling in neck and spine only at night for 2 nights , very slight headache, slight fatigue and nausea and weakness after naps, then fine by day 3 then suddenly this morning I had slight chest pain (pressure) and severe vertigo and fell in the bathroom, bp normal, temperature normal, spo2 nornal, normal hr, i had no choice but to report to work or i would lose my job (teaching in private school)
40 2021-04-07 lymph node pain, lymph node swelling Armpit/ lymph node under left arm is tender and swollen. Armpit has no indentation whether arm is do... Read more
Armpit/ lymph node under left arm is tender and swollen. Armpit has no indentation whether arm is down or lifted. Lymph node feels tender at the touch of the arm being in lowered position. Swelling extends out from and around armpit area.
40 2021-04-08 lymph node swelling Large (size of grape tomato), mobile, nontender left supraclavicular lymph node noticed 12 days afte... Read more
Large (size of grape tomato), mobile, nontender left supraclavicular lymph node noticed 12 days after vaccination. Did not connect the lump with the vaccine, and Googled "lump above collarbone." BIG MISTAKE.
40 2021-04-08 swelling face, anaphylactic reaction Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactio... Read more
Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactions: facial swelling, lips swelling, reddness, small hives. Patient was given 25mg Benadryl PO per protocol. Dr was made aware. Monitored patient. Patient started to experience some throat tightness but no shortness of breath or difficulty breathing. Spoke with Dr again and gave patient 0.3mg Epinephrine in right deltoid. Dr came down to clinic as patient was going to ED per car with her sister driving. In the ED , patient was treated for anaphylaxis at hospital and stayed overnight (epinephrine, solumedrol, pepcid x2). After discharge on prednisone 40mg daily x5 days, patient came back with hives and was readmitted and treated overnight with pepcid/benadryl expect to be discharged again today.
40 2021-04-09 lymph node swelling, lymph node pain Wed Mar 31 - day of shot Stiff neck on side of shot Sore arm on shot site Heavy period w painful cra... Read more
Wed Mar 31 - day of shot Stiff neck on side of shot Sore arm on shot site Heavy period w painful cramps for two days Swollen, painful lymph node in neck on same side as stiff neck and same side as shot - visit to chiropractor following day where it was numbed with bengay type product and vigorously rubbed. As of Saturday, Apr 10 pain and swollen lymph node still present but pain significantly less.
40 2021-04-09 lymph node swelling The night of my vaccination I spiked a fever of 104. It stayed high for three days - even with Tyle... Read more
The night of my vaccination I spiked a fever of 104. It stayed high for three days - even with Tylenol and Ibuprofen I could not get it below 100. It finally broke on the fourth day. My other symptoms lasted longer. I had terrible muscle pain and joint pain, fatigue, headaches, swollen glands, swelling and a rash at the injection site, strange bruising on my other arm, and a sore throat that made swallowing difficult. I am now nine days post-vaccine, and my only lingering symptoms are a sore throat, laryngitis, and a cough. I am healthy and have never before reacted to a vaccine. This was a terrifying and *lengthy* reaction.
40 2021-04-10 lymph node swelling Red raised areas that start at left eyebrow and go into hairline. Red raised bumps throughout scalp ... Read more
Red raised areas that start at left eyebrow and go into hairline. Red raised bumps throughout scalp on the left side. Left swollen lymph node behind ear that is continuing to swell. Pressure from lymph node swelling now felt near left eye. All bumps can be itchy at times.
40 2021-04-10 lymph node swelling Fever, nausea, swollen lymph nodes, headache, tiredness, muscle and joint pain
40 2021-04-10 lymph node swelling Lymph node swelling and tenderness in armpit, breast area - lasted about 5 days. Started about 5-7 d... Read more
Lymph node swelling and tenderness in armpit, breast area - lasted about 5 days. Started about 5-7 days after shot.
40 2021-04-10 peripheral swelling Swollen arm, light rash on arm, chills and body aches, headache
40 2021-04-11 lymph node swelling Swollen lymph nodes under left arm, left breast pain and discomfort lasting 3 weeks ( still ongoing)... Read more
Swollen lymph nodes under left arm, left breast pain and discomfort lasting 3 weeks ( still ongoing). Swollen lymph nodes around neck.
40 2021-04-11 lymph node swelling Only mild injection site discomfort following first dose. Fatigue and left arm pain within 6 hours o... Read more
Only mild injection site discomfort following first dose. Fatigue and left arm pain within 6 hours of second dose; dizziness, body aches, moderate muscle pain, joint pain, chills, swollen lymph nodes starting 8 hours after second dose. Pain lasted 24 hours. Fatigue lasted 72 hours. Muscle pain, joint pain and body aches were managed with 800 mg Ibuprofen prn.
40 2021-04-11 swelling face Approximately 48 hours after receiving Pfizer Covid-19 mRNA vaccine, patient starting immediately th... Read more
Approximately 48 hours after receiving Pfizer Covid-19 mRNA vaccine, patient starting immediately throwing up with diarrhea and then developed chest pain and breaking out into hives, then her face started swelling on R side, phlegm in her throat, rashes on her feet; had full blown panic attack once she saw the face swelling; was too nervous to use her epinephrine pens. Took Xanax, Zyrtec and Benadryl.
40 2021-04-12 lymph node swelling Swollen lymph nodes in armpits, breast, torso, groin over 15 in total appearing over 10 days. Fatigu... Read more
Swollen lymph nodes in armpits, breast, torso, groin over 15 in total appearing over 10 days. Fatigue lasting a few days. Chills for one night on the 4th day. Rash that was a cluster of red marks on lower back about half dollar size lasted for a few days. Most lymph nodes have gone down but some still noticeable.
40 2021-04-12 lymph node swelling Fever 100.9, swelling of left axillary lymph. 300 mg ibuprofen every 5 hours
40 2021-04-12 peripheral swelling presented with arm tightness and very mild swelling in the left arm. developed prominent left should... Read more
presented with arm tightness and very mild swelling in the left arm. developed prominent left shoulder veins. Found to have:1. Acute appearing partially occlusive deep vein thrombus involving the left supraclavicular subclavian vein. 2. Acute focal superficial venous thrombus involving the left cephalic vein at the antecubital fossa.
40 2021-04-12 swelling face had swelling of cheeks, lips, cough , trouble swallowing about 30 minutes after vaccine administrati... Read more
had swelling of cheeks, lips, cough , trouble swallowing about 30 minutes after vaccine administration
40 2021-04-13 lymph node swelling Have developed large red welt at injection that has been spreading slowly and continuously over past... Read more
Have developed large red welt at injection that has been spreading slowly and continuously over past 30 hours. Started approximately size of dime, is larger than a quarter after 30 hours. Red in color, hot, swollen. Left ear is starting to get swollen and painful on inside - due to swollen lymph node under ear.
40 2021-04-13 lymph node swelling I couldn't sleep the night of the day that I got the vaccine due to body aches and chills, and gener... Read more
I couldn't sleep the night of the day that I got the vaccine due to body aches and chills, and general feeling of discomfort. The next day I had a low fever that lasted the entire day, along with the body aches, chills, headache, nausea and soreness around the injection site -- basically, I felt flu-like. The fever didn't break until the following night around 1:30-2 a.m. -- so, 24 hours after symptoms started, and heading into the second day following my vaccination. I noticed the lymph nodes in both arm pits were painfully swollen, as well, which was not a side effect that I was warned about, so it freaked me out. The node in my left arm pit -- the arm where I got the vaccine -- was more swollen and painful than the right arm. And that swelling did not leave until three days after my vaccine. In short, I was feverish and ill the night I got the vaccine, and all of the following day after getting the vaccine. I still felt nauseated and had a headache two days after my vaccine -- which is when my lymph nodes in my under arms were also noticeably swollen and painful -- but the fever was gone. Three days out from the vaccine, the flu-like symptoms were gone, except for headache and fatigue. All told, I missed two days of work, and was "down for the count" feeling sick for three days.
40 2021-04-13 lymphatic obstruction, peripheral swelling Severe lymphedema of the left arm
40 2021-04-14 anaphylactic shock Amphylactic shock Numb arm Breathing Throat swelling
40 2021-04-14 lymph node swelling I have been experiencing these symptoms for three days now. -moderate dizzy spells/vertigo -severe... Read more
I have been experiencing these symptoms for three days now. -moderate dizzy spells/vertigo -severe headache -severe fatigue -sore arm in injection site -swollen lymph nodes -tingling in tongue -achy muscles/joints
40 2021-04-15 anaphylactic reaction Severe hives all over and anaphylaxis reaction
40 2021-04-15 lymph node swelling, lymph node pain I had flu like symptoms the first 48 hours with fogginess, tiredness, and achiness. The these sympto... Read more
I had flu like symptoms the first 48 hours with fogginess, tiredness, and achiness. The these symptoms seemed to get better after eating meals then got worse again off and on over the first 48 hours. When I woke up the day after the 2nd vaccine my left leg felt like it was going to give out walking on it almost like the feeling when you are pregnant and the muscles relax. This did not happen with the first dose. It lasted most of the day and part of the next eventually resolving with the right leg not showing that symptom at all. About 48 hours after the dose I experienced very painful lymph nodes. I'm breastfeeding and called my OB and described what felt like mastitis without red streaks or fever. My armpit, arm, and wrist ached. I have only experienced the wrist ache once with mastitis about 9 years ago. I'm currently taking sunflower lethicin and benadryl. Today is April 16th and I still have swollen lymph nodes and a sore arm and wrist.
40 2021-04-15 peripheral swelling Seconds after injection my left arm had an icy numb sensation from injection site to my fingers. Tod... Read more
Seconds after injection my left arm had an icy numb sensation from injection site to my fingers. Today Three weeks later I experienced same icy sensation plus numbness/weakness, decreased sensation in fingertips. 2. Still have bad Headaches still after 3 weeks 3. Extreme Fatigue still after 3 weeks 4. Last few days, three weeks after shot, I have worsening/ Increased joint pain, spiky pain in joints, chills and entire body aches like I have the flu. No fever, no runny nose, etc. Just the body aches, joint pain like people experience with the flu. 5. Decreased mental sharpest last 2 weeks since shot. 6. Light headedness, dizziness. 7. Immediately after shot I experienced metal taste in my mouth. Since the shot, I still experience occurrences of metal taste every day. 8. Today experiencing slight numbness in right foot. 9. Swelling in fingers
40 2021-04-15 swelling Heavy-feeling limbs, muscle aches, sore feet, swollen gland in armpit
40 2021-04-16 lymph node swelling tiredness; muscle and joint aches; muscle and joint aches; chills; swollen underarm lymph node; This... Read more
tiredness; muscle and joint aches; muscle and joint aches; chills; swollen underarm lymph node; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:15 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation. Other medical history was none. Concomitant medication(s) included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported; biotin (BIOTIN) taken for an unspecified indication, start and stop date were not reported. Other medications in two weeks also included oral birth control. The patient had no other vaccine in four weeks. No covid prior vaccination and not tested covid post vaccination. The patient had no known allergies. The patient previously received first dose of BNT162B2 (COMIRNATY, Batch/Lot number EL3247), in Arm Left on 22Jan2021 14:15 as single dose for COVID-19 immunization. Since 13Feb2021 10:00 AM, the patient experienced tiredness, muscle and joint aches, chills, swollen underarm lymph node. The patient did not receive any treatment for AE. Outcome of the events was recovering.
40 2021-04-16 lymph node swelling Muscle pain Joints pain Bone pain Sore body Fever Chills Severe headache Swollen linfonode of left a... Read more
Muscle pain Joints pain Bone pain Sore body Fever Chills Severe headache Swollen linfonode of left arm Nausea Diarrhea
40 2021-04-16 swelling left arm pit pain that started 4/16/21, overnight into 4/17/21 started with some swelling above left... Read more
left arm pit pain that started 4/16/21, overnight into 4/17/21 started with some swelling above left collar bone that feels fluid filled and about the size of an egg
40 2021-04-17 lymph node swelling Soreness/swollen lymph node under left arm pit the morning after injection along with swollen arm at... Read more
Soreness/swollen lymph node under left arm pit the morning after injection along with swollen arm at injection site. Soreness/swollen lymph node is still there 1 week later and has not gone down.; Swollen arm at injection site; Soreness/swollen lymph node under left arm pit; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EP7534), via an unspecified route of administration in the left arm on 23Mar2021 at 10:30 (at the age of 40-years-old) as a single dose for COVID-19 immunization. The patient medical history included asthma. The patient had allergies to medications, food, or other products which included, shellfish, penicillin, biaxin, ceclor, sulfa, Cephalosporins. Patient reported that she took concomitant medications in two weeks as Mirabegron (MYRBETRIQ). The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 07:00 patient experienced Soreness/swollen lymph node under left arm pit in the morning after the vaccination along with swollen arm at injection site. Patient stated that the Soreness/swollen lymph node is still there 1 week later and has not gone down. The patient not had covid prior vaccination; not tested covid post vaccination. The patient did not receive any treatment for the events. The outcome of events were not recovered. No follow-up attempts are possible. No further information is expected.
40 2021-04-18 lymph node swelling I developed intraparotid lymph node swelling. One lymph node measured 9mm and another 7mm
40 2021-04-18 oral herpes -Cold sore (herpes) appreared in the nostril. (I haven't had it in 6 or 7 years) -Extreme fatigue e... Read more
-Cold sore (herpes) appreared in the nostril. (I haven't had it in 6 or 7 years) -Extreme fatigue especially when sitting or laying, feel better when start walking but again feel extremely tired and sleepy as soon as sit or lay down. No fever.
40 2021-04-20 lymph node swelling Left underarm lymph node swelling appeared on 04/10 (disappeared after 2 days); left ankle peroneal ... Read more
Left underarm lymph node swelling appeared on 04/10 (disappeared after 2 days); left ankle peroneal tendonitis that required draining and treatment with cortisone, as well as future follow-up visits and physical therapy
40 2021-04-21 swelling, peripheral swelling, swelling face -LIMP ARM WITHIN 30 MINUTES OF VACCINATION -LEFT ARM, NECK, AND FACE SWELLING WITHING AN HOUR OF REC... Read more
-LIMP ARM WITHIN 30 MINUTES OF VACCINATION -LEFT ARM, NECK, AND FACE SWELLING WITHING AN HOUR OF RECEIVING VACCINE - LASTED FOR 6 DAYS -UNABLE TO MOVE LEFT ARM, RAISE IT, OR LIFT ANYTHING FOR THE PAST 18 DAYS -UNABLE TO GRASP OBJECTS WITH LEFT ARM FOR THE PAST 18 DAYS -UNABLE TO SLEEP ON LEFT SIDE - CAUSES EXTREME PAIN -TINGLING AND NERVE SHOOTING PAIN ON LEFT ARM FROM FINGERS TO NECK, FRONT AND BACK CHEST LEFT SIDE -MUSCULAR NODULE DEVELOPED ON LEFT SHOULDER UP TO MY KNECK - CAUSING SEVERE EAR PAIN -EXTREME FATIGUE - LETHARGIC FOR THE PAST 18 DAYS -SEVERE JOINT/PAINT THROUGH OUT ENTIRE BODY -LOST OF TASTE -NIGHTSWEATS FOR PAST 18 DAYS -FEVERS RANGING BETWEEN 99.0 - 103 F FOR PAST 18 DAYS -NAUSE FOR PAST 18 DAYS -LOST OF APPETITE -DIARRHEA AND LOOSE STOOLS FOR THE PAST 8 DAYS (NO BLOOD) -BRAIN FEELS FOGGY ALL THE TIME - FEELING AS IN A DAZE FOR PAST 18 DAYS -SHORTNESS OF BREATH - JUST FROM WALKING OR MOVING AROUND -SKIN IS SUPER SENSITIVE AND ITCHY -UNABLE TO DRIVE BECAUSE OF THE FATIGUE AND UNABLE TO USE LEFT ARM. -UNABLE TO WORK - RELYING ON OTHERS TO TAKE CARE OF ME.
40 2021-04-21 white blood cell count increased Patient was initially seen on 4/16 in the ED and discharged after complaints of myalgias. She was t... Read more
Patient was initially seen on 4/16 in the ED and discharged after complaints of myalgias. She was tested for COVID and discharged home and instructed to take acetaminophen. On 4/20, she returned to the ED with continued complaints including abdominal pain, nausea, and diarrhea. She also complained of dizziness when she stands, and that her skin and eyes were jaundiced. The patient was hypotensive and was not responding to IV fluids. She was started on vasopressors. She was found to be in acute liver and kidney failure. She was emergently intubated and ended up being transferred to hospital. Due to the nature of her condition, the above therapies were continued and CRRT was started due to acidosis. A bicarb drip was started and was continuous. Arrangements were made to transfer the patient to hospital once stable enough. It was thought that she was in HLH. She was also empirically started on hydrocortisone, later changed to dexamethasone. She was started on antibiotics - cefepime, Flagyl, and vancomycin. She has now been transferred to hospital. Outcome unknown at this time. 4/22
40 2021-04-22 swelling face, swelling Left side of jaw/upper left neck became swollen after numbness/tingling episode after eating a hour ... Read more
Left side of jaw/upper left neck became swollen after numbness/tingling episode after eating a hour after COVID injection left arm. Went to urgent care, doctor stated he had not heard of this being a side effect of COVID vaccine and felt it was inflammation of salivary gland . He prescribed a antibiotic and told me to f/u if no better, symptoms continue. I had experienced no issues prior to the vaccine. (In regards to salivary gland)
40 2021-04-24 anaphylactic reaction anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed ... Read more
anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed to swollen lips, tongue; cough; throat irritation; wheezing; This is a spontaneous report from a contactable consumer (patient). The 40-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number: EW0150 expiry date unknown) via an unspecified route of administration on Left arm as a single dose on 06Apr2021 09:30 AM. Medical history included asthma, known allergies: Biaxin, albuterol, xopenex, apples, pears, stone fruit (peaches, plums, apricot, etc), almond, hazel-nut. Concomitant medications included Zyrtec, Nasonex, Flovent, Singulair and Zoloft. On 06Apr2021 10:00 AM, started with rash/hives on face, then progressed to swollen lips, tongue, cough, throat irritation/swelling and wheezing. Initially treated in emergency room (ER) for anaphylaxis then released. Within 30 minutes, symptoms returned and was treated ER for anaphylaxis and was admitted for observation. She was discharged in the morning of 07Apr2021, but had to return to ER that evening, and was discharged in the morning of 09Apr2021. She was treated with Epinephrine, Benadryl, steroids and Pepcid. She did not receive any other vaccine in four weeks prior to the suspect. The patient was not suffering from covid prior vaccination. On 06Apr2021, she was tested through Nasal Swab for Covid and results were found to be negative. The outcome of events was recovering. No further information was available.
40 2021-04-25 axillary mass Discovered a painful lump in my armpit on the side of the injection.
40 2021-04-26 swelling, swelling face, peripheral swelling Patient stated she took the vaccine on Monday 4/5/21 @1600 and within 10 minutes she felt her arm st... Read more
Patient stated she took the vaccine on Monday 4/5/21 @1600 and within 10 minutes she felt her arm started to go numb and it was swollen (face and neck), radiating back pain and a nodule in neck and pain shooting all throughout the arm, loss of appetite, n/v, sob (no chest pain), lethargic, fever (ranging from 99-103), diarrhea developed within the last week, lost a sense of taste, headache, she can move arm but she's in a lot of pain.As of 4/22/21 patient is just experiencing shooting arm pain, nausea, fever, lethargic, SOB (patient feels exhausted when moving around the house), and started to experience some itchyness as of this morning. Patient took tylenol at least 6 times since she took the vaccine, she stated it helps with the pain but once it wears off the pain comes back. Advised patient to continue with the tylenol/ibuprofen for the fever and pain, and benadryl to help with itchiness or she can apply benadryl cream/hydrocortisone to help. Also advised her that if her sob continues and it gets worse to seek medical attention (ER or urgent care). 4/25-Patient continues with fever, negative for Covid test, continues with loss of taste, recommended for her to see primary provider.
40 2021-04-27 lymph node swelling, lymph node pain Injection site pain; Nausea; back pain; lymph node in underarm of injection swollen; lymph node in u... Read more
Injection site pain; Nausea; back pain; lymph node in underarm of injection swollen; lymph node in underarm of injection pain; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201) via unknown route of administration on 18Feb2021 05:00 PM at single dose in left arm for COVID-19 immunisation at Hospital. Medical history was known drug allergies to Bactrim. Patient was not pregnant at time of vaccination. No other vaccine in four weeks. Concomitant medication included in two weeks lorazepam. The patient previously took first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261) on 25Jan2021 (at 40-year-old age) 09:00 AM for Covid-19 immunisation. The patient had experienced injection site pain, nausea, back pain, lymph node in underarm of injection swollen and painful on 18Feb2021 08:30 PM. No treatment for adverse events. No COVID tested post vaccination. Outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
40 2021-04-27 lymph node swelling Fatigue, chills 4/26-4/26 Injection site soreness 4/26-4/27 Swollen lymph nodes right under arm 4/27... Read more
Fatigue, chills 4/26-4/26 Injection site soreness 4/26-4/27 Swollen lymph nodes right under arm 4/27-ongoing
40 2021-04-28 bursitis Likely bursitis of shoulder according to her PCP. Patient is experiencing pain and numbness. She is ... Read more
Likely bursitis of shoulder according to her PCP. Patient is experiencing pain and numbness. She is also experiencing immobility.
40 2021-04-28 bursitis Cervical radiculopathy; muscle spasms; neurological pain down right arm; bursitis right elbow; menst... Read more
Cervical radiculopathy; muscle spasms; neurological pain down right arm; bursitis right elbow; menstrual changes - ovarian cyst; menstrual changes - ovarian cyst; carpal tunnel; This is a spontaneous report from a contactable nurse (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 28Dec2020 10:00 (lot number and expiration date were not reported) as single dose (at the age of 40-years-old) for COVID-19 immunisation. The patient was vaccinated in a hospital. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient had no other vaccines in four weeks. The patient did not have COVID prior to vaccination. On 01Jan2021 at 6 pm, the patient experienced cervical radiculopathy, muscle spasms, neurological pain down right arm, bursitis right elbow, menstrual changes - ovarian cyst and carpal tunnel. The adverse events resulted in a doctor/healthcare professional clinic visit and was considered a disability/permanent damage. The patient received treatment of "PT, Mobic, soma, ultram and trigger point injection. The patient has not recovered from the events. The patient had a negative nasal swab test on 16Jan2021. The patient received the second dose administered in the left arm on 19Jan2021 (lot number and expiration date were not reported) at a single dose. Information about the lot/batch number has been requested.; Sender's Comments: The events cervical radiculopathy, muscle spasms, neurological pain down right arm, bursitis right elbow, menstrual changes, ovarian cyst and carpal tunnel most likely represent intercurrent medical conditions that are assessed as unrelated to BNT162B2. The case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-04-28 lymph node swelling I have armpit pain in the arm where I received the shot. It feels like the lymph noids in my armpit ... Read more
I have armpit pain in the arm where I received the shot. It feels like the lymph noids in my armpit are completely swollen.
40 2021-04-28 swelling face Ear and face swelling. Headache nausea body aches chills. I tool benadryl and ibprophin
40 2021-05-01 lymph node swelling Chills, sweating, body aches, headaches, blotches (rash), itching, vomiting, fatigue, constantly sle... Read more
Chills, sweating, body aches, headaches, blotches (rash), itching, vomiting, fatigue, constantly sleeping, joint pain, nauseous, swollen lymph nodes, sore throat
40 2021-05-01 oral herpes Break out of cold sores....5 in all. Which is unusual since I have a break out once a year when I ge... Read more
Break out of cold sores....5 in all. Which is unusual since I have a break out once a year when I get a cold and it is only one blister not 5.
40 2021-05-04 lymph node swelling I began feeling chills around 9pm and continued until bed, woke up several times in the night in pud... Read more
I began feeling chills around 9pm and continued until bed, woke up several times in the night in puddles of sweat, all parts of my body were hot to the touch. Also had pain under my left armpit, like there were marbles underneath my skin, I'm assuming lymph node swelling, also same feeling in my right groin. Headache and general body ache all over. Fatigue. Slept until around 11am next morning, May 4. Took Advil and felt somewhat better until evening of May 4, when I started chilling again and armpit soreness and headache. Took more Advil and went to bed. Better next morning May 5.
40 2021-05-04 swollen extremities, axillary mass Lump in left underarm, swollen and tender
40 2021-05-04 peripheral swelling Feet swollen and red spots on the bottom of feet. Looked like broken capillaries. Toes where swollen... Read more
Feet swollen and red spots on the bottom of feet. Looked like broken capillaries. Toes where swollen and a little darker in color. Did not hurt or cause any pain.
40 2021-05-05 swelling Tingling throat Swollen Uvula Very stiff/swollen neck feeling
40 2021-05-06 lymph node swelling Swollen lymph nodes under arm, body soreness
40 2021-05-06 lymph node swelling pain, swelling in lymph nodes in right armpit and above breast on the same side as the injection. I... Read more
pain, swelling in lymph nodes in right armpit and above breast on the same side as the injection. It's been over 72 hours since the first dose of Pfizer
40 2021-05-07 lymph node swelling Metallic taste in mouth Severe back muscle pain Swollen groin lymph nodes Headache Chills Gener... Read more
Metallic taste in mouth Severe back muscle pain Swollen groin lymph nodes Headache Chills Generalized severe pain throughout body Pain to move
40 2021-05-07 swelling face Moderate Swelling under right eye where Hyaluronic Acid Dermal Filler previously was.
40 2021-05-10 lymph node swelling, lymph node pain Within a few days of receiving my first COVID-19 vaccine, I experienced painful swelling of my lymph... Read more
Within a few days of receiving my first COVID-19 vaccine, I experienced painful swelling of my lymph nodes in my left armpit (the same side as the injection site). The tenderness in my lymph nodes lasted several days, but they have remained enlarged. It's now three weeks after my first dose and I haven't noticed much reduction in size yet. My second dose is scheduled for next week on 05/17/21.
40 2021-05-10 lymph node swelling Swollen supraclavicular lymph nodes on side of vaccine. Have not gone down after four weeks.
40 2021-05-10 swelling face Pt received the second dose of Pfizer BioNTech Covid 19 Vaccine (exp. 8/2021) at 1132. At 1202, pati... Read more
Pt received the second dose of Pfizer BioNTech Covid 19 Vaccine (exp. 8/2021) at 1132. At 1202, patient reported swelling and tingling on right cheek. Patient denied itchiness, rashes, hives, and difficulty breathing/swallowing/talking. Patient reported similar reaction to penicillin, no current medications and a heart murmur since she was a child. EMT assessed patient vital: blood pressure 140/60 mmHg, heart rate 106 bpm, and SpO2 98%. Patient given water. Patient tolerated drinking water. Patient offered oral diphenhydramine. Lead Nurse administered 2 doses of 25 mg/10 ml oral diphenhydramine at 1209. At 1214, vitals reassessed: blood pressure (unable to obtain due to unreliable blood pressure cuff, heart rate 98 bpm, SpO2 97%, and patient reported decreased swelling. At 1228, vitals reassessed: blood pressure (unable to obtain due to unreliable blood pressure cuff, heart rate 94 bpm, SpO2 98%, and patient reported decreased swelling. At 1233, patient reassessed. Patient reported swelling and tingling on right cheek "went away". Lead nurse educated patient on signs/symptoms of when to seek emergency care, to see an allergist, follow up with primary care provider about reaction to vaccine, and how to sign up on v-safe. Patient left facility with husband at 1235. Patient left facility with unlabored respirations and steady gait.
40 2021-05-11 swelling face Pt received 2nd dose of Pfizer CIOVID-19 vaccine today, 5/12/2021 and within 5 minutes reports lip a... Read more
Pt received 2nd dose of Pfizer CIOVID-19 vaccine today, 5/12/2021 and within 5 minutes reports lip and face swelling and throat tightness. Pt denied any reactions from 1st dose of Pfizer COVID-19 vaccine, but report she has idiopathic anaphylaxis, an autoimmune disorder, chronic hives, asthma and she has anaphylactic episodes about once a month. Pt given 2 epi pen autoinjections in thigh in office prior to EMS arrival. Pt was transported in stable condition to Hospital ER via EMS for further evaluation and monitoring.
40 2021-05-12 lymph node pain, lymph node swelling Painful and swollen lymph nodes under both armpits. Right side was significantly more painful. Pain... Read more
Painful and swollen lymph nodes under both armpits. Right side was significantly more painful. Pain spread into the right breast. Lasted for 5 days with strong symptoms, mild pain (right side only) continued for additional 3 days. Patient is a nursing mother.
40 2021-05-12 pancreatitis Pancreatitis flare-up began as the side effects intensified/ Felt like pancreatic and GI inflammatio... Read more
Pancreatitis flare-up began as the side effects intensified/ Felt like pancreatic and GI inflammation; Pancreatitis flare-up began as the side effects intensified; Felt like pancreatic and GI inflammation; Could't keep any food or liquid down; vomited green stomach bile; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 11:45 AM (Batch/Lot Number: ER8734) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 40 years old. Patient was not pregnant. Medical history included Chronic Pancreatitis (idiopathic) from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Occassional Benadryl allergy and Tylenol, both taken for an unspecified indication, start and stop date were not reported. The patient previously took clindamycin and experienced known allergies, bnt162b2 for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (brand=Pfizer; lot number=EW0172) on Apr2021 03:45 PM at Left arm for covid-19 immunization. The patient experienced pancreatitis flare-up began as the side effects intensified (medically significant), felt like pancreatic inflammation (medically significant), GI inflammation (non-serious), could't keep any food or liquid down (non-serious), vomited green stomach bile (non-serious), all on 25Apr2021 18:00 with outcome of recovering. Reported as pancreatitis flare-up began as the side effects intensified. Could't keep any food or liquid down and vomited green stomach bile. Felt like pancreatic and GI inflammation as my immune system responded to vax. No treatment received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected
40 2021-05-13 swelling Large hard bump on day 1, day 2 it became smaller but more spread out and red. Hot and itchy from da... Read more
Large hard bump on day 1, day 2 it became smaller but more spread out and red. Hot and itchy from day 1. Taken benadryl both days. Slight improvement.
40 2021-05-14 lymph node pain Dose 1 - soreness at injection site; mild fatigue for a 3-4 days, swollen lymph nodes under left arm... Read more
Dose 1 - soreness at injection site; mild fatigue for a 3-4 days, swollen lymph nodes under left armpit about 5-7 days after the dose was given that lasted for 4-5 days. Dose 2 - mild swelling and soreness at injection site beginning in first 24 hours after dose given; active chills for about 30 min beginning just shy of 12 hours after dose was given; nausea and vomiting that last 24 hours after symptoms began; intermittent neck and head pain (sometimes sharp/severe head pain) over first 24 hours after symptoms began; dull headache with light and noise sensitivity between 24-48 hours; backache for 2-3 days; fatigue for first 24-48 hours. Dose given on Tuesday afternoon and worst symptoms experienced Wednesday, feeling slightly better by Thursday morning but milder symptoms described above returned midday. Friday, I was cautiously returning to very light activity around the home and without previous symptoms, but refrained from being up and about too much, as I would feel off and slightly light headed. As of this morning (Saturday), only soreness/light swelling at injection site and slight lymph node pain remain.
40 2021-05-14 lymph node swelling 101.2 fever, rigors, body aches, exhaustion, enlarged lymph nodes under right arm, partially numb up... Read more
101.2 fever, rigors, body aches, exhaustion, enlarged lymph nodes under right arm, partially numb upper lip
40 2021-05-14 oral herpes high blood pressure; chest pains; cold sore; dizzy / lightheaded; vision is blurry; tingling in hand... Read more
high blood pressure; chest pains; cold sore; dizzy / lightheaded; vision is blurry; tingling in hands and feet; Memory loss; experienced early period with clotting which stopped in 2-3 days then started faint spotting; Throat closure sensations; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 03Apr2021 (Batch/Lot Number: Er8734) as single dose at the age of 40-year-old for covid-19 immunisation. Medical history included allergy to amoxicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. No other medications the patient received within 2 weeks of vaccination. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date the patient experienced early period with clotting which stopped in 2-3 days then started faint spotting again a day later, high blood pressure, cold sore, dizzy / lightheaded, vision is blurry, chest pains, tingling in hands and feet, memory loss. On 03Apr2021 18:00 the patient experienced throat closure sensations. The course of events was as follows: Throat closure sensations, high blood pressure, chest pains, cold sore, dizzy / lightheaded, early period with clotting which stopped in 2-3 days then started faint spotting again a day later. After 25 days, I am still dizzy and have tingling in hands and feet. Memory loss, and vision is blurry. The adverse events resulted in Doctor visit, Emergency room/department or urgent care. The events early period with clotting and started faint spotting again a day later, throat closure sensations were considered medically significant. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.
40 2021-05-14 peripheral swelling difficulty walking; difficulty with speech / slurred speech; fingers are going numb holding the phon... Read more
difficulty walking; difficulty with speech / slurred speech; fingers are going numb holding the phone; feels like she is coming down with a respiratory illness; nausea; vomiting; cough; sweating; headache; body pain, achy and uncomfortable; body pain, achy and uncomfortable; overall feeling badly; cognition was not there; Problems with breathing; aspirating; sleepiness; fatigue; stomach pain; her nerve response is strong/affected; swelling in hands and feet; had arm soreness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0162), via an unspecified route of administration in the left arm, on 23Apr2021 at 15:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing neuropathy (few years ago, at least since 2015 or 2016), seizures or epilepsy (had focal/absence seizures since a kid; not on any seizure medication, do have a neurologist), hard time with her vision, cancer from an unspecified date to an unspecified date (cancer as a teenager but has been cancer-free for a very long time), and glaucoma. The patient had a family history of cancer and heart problem. Concomitant medications included latanoprost (MANUFACTURER UNKNOWN) taken for glaucoma from Apr2021 and ongoing and gabapentin (MANUFACTURER UNKNOWN) taken for neuropathy from an unspecified start date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ER8730), intramuscularly in the left arm, on 02Apr2021 for COVID-19 immunisation and experienced not very many side effects with first dose, not enough to be a problem; influenza vaccine (MANUFACTURER UNKNOWN) in 2021 (maybe) for immunisation; and polio vaccine (MANUFACTURER UNKNOWN) as a child for immunisation and experienced severe pain in her legs and she had trouble walking because of pain. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced difficulty walking and difficulty with speech / slurred speech on 23Apr2021, which required hospitalization from Apr2021 to 26Apr2021. The patient also experienced body pain, achy and uncomfortable, overall feeling badly, cognition was not there, and problems with breathing on 23Apr2021; sweating and headache on 26Apr2021; vomiting and cough on 27Apr2021; feels like she is coming down with a respiratory illness and nausea on 28Apr2021; sleepiness, fatigue, stomach pain, her nerve response is strong/affected, swelling in hands and feet, aspirating, and had arm soreness in Apr2021; and fingers are going numb holding the phone on 29Apr2021. The clinical course was reported as follows: The patient stated that she works in healthcare support and she is a first responder; she identifies as a person with a disability (unspecified). She stated that she did not have very many side effects with first dose, not enough to be a problem. By dinnertime, closer to 18:00-19:00 on 23Apr2021, she started experiencing difficulty walking and with her speech. She was concerned about having a stroke but that she is active and generally healthy. This was unusual for her and she started feeling pain through her body and overall feeling like crap. She did not expect the neurological stuff. By the end of the night on 23Apr2021, she realized she was not feeling good and went to the hospital either that night on 23Apr2021 or early the next day on 24Apr2021 and was admitted to the hospital. The patient stated that her cognition was not there, and her speech was kind of slurry, she felt like everything was slowing, and did not feel like herself. She could not get up unassisted, could not get up out of the bed, chair, or go to bathroom, and still requires the use of a walker and bedside commode, but now with the walker and assistance caller can make it to the bathroom. She also had problems with breathing, but she had a negative COVID-19 PCR test in Apr2021 both arriving to and leaving from the hospital; she did not believe them to be COVID-19 symptoms. At the hospital they did an x-ray or computerized tomography (CT) scan and a magnetic resonance imaging (MRI) on her brain in Apr2021 with unknown results. They gave her 3 or 4 intravenous (IV) unspecified medications and she had her complete blood count (CBC) labs done in Apr2021 with unknown results. There was an issue with her lungs, and she is currently waiting for her doctor to read report to see if there is an issue there. The patient stated that she never experienced anything like this after a vaccine. She cannot even get up and move around it is pretty serious. Caller states that at first when she had the symptoms, she thought she was going to wait it out, maybe her immune system is overresponding, give it a chance to resolve. She reported that she could not stand up, legs were shaking and that she had pain that was from her breasts down; felt like a ton of bricks. The patient stated that she is cognitively alert now, speaking normal. There are times it goes in waves where she feels like she can walk with walker but then a few hours later that is not the case. On Tuesday, 27Apr2021 night, the patient had a light dinner but then she was vomiting. Caller states that the pain was throughout her body and felt like someone lighting firecrackers. The patient initially stated 28Apr2021 was when the cough started, but later clarified she first noticed it on 27Apr2021, but at that time she was vomiting and thought it was due to that. However, the next day 28Apr2021, she still had this cough and that the cough was getting worse. She felt like she has a respiratory issue and has been coughing. She was not able to stay awake, even without taking any medications. She does take medications regularly but did not take the medications those days and not having medications would not cause sleepiness. She thought the doctor gave her sedative, but they did not. She states she had fatigue to the point where she was dead asleep, and nurse would come in to take vitals or do whatever and she would wake up suddenly with someone in front of her. She was sitting up with the nurse trying to read the discharge instructions and she fell asleep sitting up. She also complained of stomach pain. The patient had not been to work and not been having to use her brain and talking like she would for 8+ hours a day. She stated that the cough hurts, it feels like somebody is lighting firecrackers in her body. It also feels like this when she sneezes; the nerve response is strong. She reported that it is not a constant hacking cough, not really a dry cough; the cough is in-between productive and dry cough and cough is a bit better now and worse towards the evening. She still has swelling in her feet and hands. It looks like it has gone down a bit. She has a history of neuropathy and that her fingers are going numb holding the phone now. She got the shot in her left arm and those fingers are going numb. She was so tired and feels like did not get enough sleep. The fatigue had a slight improvement. She is more awake than when she was in the hospital. However, it depends as the day goes on, she is wiped out and has to go lay down. She stated that her nerve response is affected, and she had a difficult time with the neuro exam in Apr2021 with unknown results in the hospital. She was having an issue with her arms. She can't say anything about whether it affected her vision because she already has a hard time with her vision. She stated that she was throwing up pretty bad; the pain was really severe through her whole body while vomiting. After the vomiting stopped, the coughing got worse and she was coughing a little bit before the vomiting, but during the vomiting it was to the point she felt like she was drowning. She reported that she was vomiting through her nose and aspirating. After her MRI she started to get a really bad headache. Then when the nurse was coming to read the discharge information, she started to get sweats. She is not menopausal so she cannot blame the sweating on menopause, as reported. The patient also had arm soreness, but does not care about that long as it does not leave any scars. This was not a big deal for her at all. This started shortly after getting the vaccine. She waited for the observation time and no sensation out of the normal, then later towards the night started feeling like having really bad mensural cramps, like an achy feeling where have to go lie down. Then her lower half started to get worse. Her arms were affected and difficult time with the neuro testing. The patient stated she is now on the road to recovery. The clinical outcome of difficulty walking, difficulty with speech / slurred speech, body pain, achy and uncomfortable, nausea, sleepiness, fatigue, and stomach pain was recovering and of overall feeling badly, cognition was not there, problems with breathing, sweating, headache, vomiting, cough, feels like she is coming down with a respiratory illness, her nerve response is strong/affected, swelling in hands and feet, aspirating, had arm soreness, and fingers are going numb holding the phone was unknown.
40 2021-05-14 peripheral swelling then itch was mild for 1 hour/Started itching all over the worst was behind; itching all over the wo... Read more
then itch was mild for 1 hour/Started itching all over the worst was behind; itching all over the worst was behind my eyes deep in sockets; Sharp pain both arms 1 min.; left arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 30Apr2021 at 11:15 (at the age of 40-years-old) as 1st dose, single for COVID-19 immunisation. Medical history was reported as yes but not specified. The patient's concomitant medications were not reported. On 30Apr2021 at 11:15, the patient experienced sharp pain both arms for 1 minute then itch was mild for 1 hour. Started itching all over the worst was behind her eyes deep in sockets that lasted 2 days, had to take diphenhydramine (BENADRYL). Left arm was swollen that night and lasted 2 days. On day 3, she was still itching but not as bad. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
40 2021-05-15 guillain-barre syndrome I was experiencing some muscle weakness in my lower extremity since Apr 3rd, one week after my first... Read more
I was experiencing some muscle weakness in my lower extremity since Apr 3rd, one week after my first shot of Pfizer on March 29th. The symptoms worsened over the next couple weeks limiting my mobility and resulting in unexpected falls. I could walk around the house and work sitting on my chair but was unable to climb up and down the stairs or run etc. I thought I had injured my quads during my regular workouts but during my annual check with my doctor on Tuesday Apr 20th we figured out it was a side effect of the Covid vaccine, where in the antibodies from the vaccine were actually attacking my healthy peripheral nerves resulting in muscle weakness and inability to move around comfortably and is called the GBS syndrome (Guillain-Barré syndrome). Unfortunately I had already taken the 2nd shot on Monday April 19th, before my doc?s appointment but fortunately we caught this in time to get me admitted to ER and do the tests to confirm GBS and my IVIG treatment started the very next day i.e. Wednesday April 21st till Sunday April 25th.
40 2021-05-16 peripheral swelling A few hours after patient received vaccine, she felt pain in her arm, swelling and redness. She iced... Read more
A few hours after patient received vaccine, she felt pain in her arm, swelling and redness. She iced her arm. She had swelling in her arm for 2 days. Pain lasted for 3 days. She took some Tylenol to help with the pain the second day. She is worried about the abnormal marking on her arm that has not gone away yet.
40 2021-05-17 lymph node swelling, lymph node pain Muscle aches; tiredness; injection site pain (left arm); swollen and painful lymph nodes in left arm... Read more
Muscle aches; tiredness; injection site pain (left arm); swollen and painful lymph nodes in left armpit and left side of neck; painful lymph nodes in left armpit and left side of neck; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0172), via unspecified route of administration in left arm on 30Apr2021 16:30 at age of 40-year-old at single dose for COVID-19 immunization. Medical history included allergies, arthritis. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant at time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0158) in Apr2021 05:45 PM in Left arm for COVID-19 immunization. The patient received medications within 2 weeks of vaccination included ibuprofen. The reported event included muscle aches, tiredness, injection site pain (left arm), swollen and painful lymph nodes in left armpit and left side of neck. Adverse Event start on 30Apr2021 07:00 PM. Seriousness criteria was reported as non-serious. No Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Since the vaccination, the patient had not been tested for COVID-19. No treatment received. It was unknown if patient recovered from events. No follow-up attempts are needed. No further information is expected.
40 2021-05-17 lymph node swelling 4/27/2021 - Swollen lymph nodes, fatigue, body and head aches began on 4/27/2021 4/29/2021 - Covid-1... Read more
4/27/2021 - Swollen lymph nodes, fatigue, body and head aches began on 4/27/2021 4/29/2021 - Covid-19 test (negative result) & Prescribed Prednisone 10mg 5-4-3-2-1 dosage on 4/29/2021 5/2/2021 - Revisited doctor due to continued fatigue, body and head aches. Lymph nodes less swollen but still enlarged. Blood test performed 5/3/2021 tested positive for re-activated Mononucleosis
40 2021-05-18 lymph node pain, lymph node swelling Severe Pain and pressure in my head as I worry if I got a blood clot. A big and painful pimple under... Read more
Severe Pain and pressure in my head as I worry if I got a blood clot. A big and painful pimple under the arm.
40 2021-05-18 swelling After 2nd dose of COVID-19 Vaccine received 4/23/2021 the following symptoms appeared: 12 hours pos... Read more
After 2nd dose of COVID-19 Vaccine received 4/23/2021 the following symptoms appeared: 12 hours post-dose: Fever (101.2F) Chills Headache Body aches (muscle, joint and low-back pain) Lethargy 48 hrs post-dose: Pain, swelling, and itching in Left armpit (same side as injection)
40 2021-05-20 lymph node swelling 101 fever, vomiting, pain behind knees, armpits neck, swollen bump on collar bone, headache
40 2021-05-20 swelling got vaccine at 6, rash started 9pm at home. Rash on neck, both legs bottom legs, more on left, some ... Read more
got vaccine at 6, rash started 9pm at home. Rash on neck, both legs bottom legs, more on left, some swelling
40 2021-05-22 peripheral swelling Both right and left middle fingers got swollen. Both right and left middle fingers are painful to m... Read more
Both right and left middle fingers got swollen. Both right and left middle fingers are painful to move. Both right and left middle fingers feel as if they have a tight ring on them, but there is no ring on them. Sometimes the pain goes to the palm of my hands. I have had these symptoms for two moths now.
40 2021-05-25 lymph node swelling Left arm soreness; Soreness on left side of breast as well as right; Lymph nodes enlarged; spotting;... Read more
Left arm soreness; Soreness on left side of breast as well as right; Lymph nodes enlarged; spotting; 1 week early than normal menstrual cycle; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in the left arm on 09Mar2021 12:00 (Batch/Lot Number: Eng205) as SINGLE DOSE for covid-19 immunisation. Patient had no medical history. Concomitant medication included ashwagandha (ASHWAGANDHA) taken for an unspecified indication, start and stop date were not reported. On 11Mar2021, the patient experienced Left arm soreness for 2 days. Soreness on left side of breast as well as right. (Lymph nodes enlarged) spotting noticed 6 days after vax, 1 week early than normal menstrual cycle. The outcome of events was reported as unknown.
40 2021-05-26 c-reactive protein increased Before the vaccine, I had complete normal monthly periods. 28 days clockwork. I have not had a perio... Read more
Before the vaccine, I had complete normal monthly periods. 28 days clockwork. I have not had a period since the vaccine. My FSH level have gone from normal, to 46.2mIU/ml. My prolactin is also elevated to 46.670 ng/ml CRP is elevated as well. I have hot flashes and night sweats and racing heartbeats. My doctor is going to re-run labs but has also ordered an MRI pituitary study
40 2021-05-26 lymph node pain, lymph node swelling high fever - 102 F; very swollen and painful lymph nodes in left armpit and right but not as bad swe... Read more
high fever - 102 F; very swollen and painful lymph nodes in left armpit and right but not as bad sweaty feet; very swollen and painful lymph nodes in left armpit and right but not as bad sweaty feet; very swollen and painful lymph nodes in left armpit and right but not as bad sweaty feet; abnormal horrific headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0179 and expiration date was not reported), via an unspecified route of administration in left arm, on 17May2021 at 14:30 (at the age of 40 years old) as second dose, single for COVID-19 immunization in a Public Health Clinic/Veterans Administration facility. The patient's medical history was not reported. The patient previously took prochlorperazine maleate (COMPAZINE) and experienced drug allergy. Concomitant medications included esomeprazole sodium (NEXIUM) and celecoxib (CELEXA). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0172 and expiration date was not reported), via an unspecified route of administration in left arm, on Apr2021 at 10:30 (at the age of 40 years old) as first dose, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19 and post-vaccination, the patient was tested for COVID-19 with nasal swab and the result was negative on 16Apr2021. The patient experienced high fever with a temperature of 102 F, very swollen and painful lymph nodes in left armpit and right but not as bad sweaty feet and abnormal horrific headache on 17May2021 at 14:30. This case was considered as non-serious and no treatment was given to the patient for these events. The outcome of these events was recovering at the time of report.
40 2021-05-26 lymph node pain Very unusually heavy period; painful lymph nodes in armpit and under arm of right side where shot wa... Read more
Very unusually heavy period; painful lymph nodes in armpit and under arm of right side where shot was administered; painful lymph nodes in armpit and under arm of right side where shot was administered; This is a spontaneous report from a non-contactable other hcp (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. Pregnant at the time of vaccination was No. No known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history was none. The patient's concomitant medications were not reported. After 1st shot, the patient experienced painful lymph nodes in armpit and under arm of right side where shot was administered. This pain started 5 days post vaccine and lasted 3 weeks! The patient also experienced very unusually heavy period as well. The adverse events resulted Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Advil, counseling. The outcome of events "painful lymph nodes in armpit and under arm of right side where shot was administered" was not recovered, the other event was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
40 2021-05-26 oral herpes Left side face numb, droopy; Huge cluster of cold sores left side face. Mouth and eye; Lips cherry r... Read more
Left side face numb, droopy; Huge cluster of cold sores left side face. Mouth and eye; Lips cherry red; Huge cluster of cold sores left side face. Mouth and eye; Left side face numb, droopy; Loss appetite; Kidney pain; mild body aches; tired and not wanting to do anything; simply not feeling well,; This is a spontaneous report from a contactable other hcp (patient). A 40-year-old female non-pregnant patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at age of 40 years old as single dose for covid-19 immunization. Medical history included Asthma, allergies, Herpes Virus and Penicillin allergies. Concomitant medications included montelukast sodium (SINGULAIR); fluticasone propionate, salmeterol (WIXELA INHUB); salbutamol sulfate (PROVENTIL HFA); cetirizine hydrochloride (ZYRTEC ALLERGY); budesonide (RHINOCORT ALLERGY). No other vaccines received within 4 weeks prior to the COVID vaccine. No covid prior vaccination. Covid tested not done post vaccination. The patient previously took Amoxicillin and experienced allergies, first dose of bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) (Lot number: EW0185) on 08May2021 10:13 AM at Right arm as single dose for covid-19 immunization. Adverse events occurred after 1st dose from 09May2021 07:00 AM included mild body aches, no arm pain, tired and not wanting to do anything after few days, simply not feeling well, loss appetite and kidney pain. Acyclovir was received as treatment and not recovered. After 2nd dose, lips were cherry red next day. By end of day, huge cluster of cold sores left side face, mouth and eye. Left side face was numb, droopy. The patient still had no will do anything but didn't feel sick. Loss appetite and kidney pain progressed from time 1st dose to 2nd. The outcome of the events was unknown. Information on lot number/batch number was requested.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the event so facial droopy, huge cluster of cold sores left side face, mouth and eye cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : 2021530924 same patient/reporter/drug, different AE/dose
40 2021-05-27 lymph node pain, lymph node swelling I had the typical sore arm after the short for approximately 72 hours. The worst of it, the first 2... Read more
I had the typical sore arm after the short for approximately 72 hours. The worst of it, the first 24. I did get some intense diarrhea as well for a few days but as I'm near my period, I haven't any idea if it's due to that. On the 27th of May in the evening, I noticed my lymph nodes visibly swollen out of nowhere by my clavicle and they were incredibly painful to palpate. Upon going to the ER they noted that my lymph nodes in my throat were also swollen but not painful. This being a new thing to me, I called the nurse line who advised me to go to the ER. The ER said I didn't have cancer (not helpful) and would not talk about any side effects. I got a Covid test (negative). They sent me home and told me if I have issues breathing or anything, to return. 5/28 I started developing some nausea, congestion, headache, and fatigue, and I have lacked appetite all day. Around 6 pm I developed, so far, one hive on my abdomen.
40 2021-05-27 swelling, lymph node swelling Swollen lymph nodes in multiple locations including armpits, groin, collarbone, neck, side of breast... Read more
Swollen lymph nodes in multiple locations including armpits, groin, collarbone, neck, side of breast. Lasted for over a week and still not completely gone
40 2021-05-28 lymph node swelling Large Swelling of the supraclavicular on the left hand side of the body with pain. Fever, chills, jo... Read more
Large Swelling of the supraclavicular on the left hand side of the body with pain. Fever, chills, joint pain, bone pane, teeth pain, inability to sleep.
40 2021-05-29 lymph node swelling fever, body aches, fatigue, swollen lymph nodes in armpit
40 2021-05-30 swelling, lymph node swelling The first shot I had a period starting one week after and lasted almost 3 weeks total. I have IUD fo... Read more
The first shot I had a period starting one week after and lasted almost 3 weeks total. I have IUD for two years and I?ve never had a full period with IUD. Prior to IUD I was normal cycle 28 days period for 6 days for 25+ years. Second dose/2nd shot in right arm I have swelling in my armpit lymph nodes from 2nd day until 4th day and I?m reporting on my fourth day after my 2nd shot. I?m breastfeeding my 2 year old child. I have not gone into the doctor yet.
40 2021-06-01 lymph node swelling, lymph node pain under arms nodes are swollen, and throat lympth nodes swollen and painful for 16 days
40 2021-06-03 swelling face, swelling Angioedema ? large hives, swelling of face and eyes, itching and fatigue
40 2021-06-03 swelling face doesn't have much of appetite; 148/70 on the blood pressure; allergic response; tongue was a little ... Read more
doesn't have much of appetite; 148/70 on the blood pressure; allergic response; tongue was a little numb; hard to swallow; Throat was closing up; mouth feeling numb; couldn't really speak; Coughing; super shaky; feet was also feeling numb; face looked swollen; Chest tightness; chest pain; abnormal EKG; Her throat was a little sore; tired; This is a spontaneous report received from a contactable consumer (patient). A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left Arm on 17May2021 12:30 (Batch/Lot Number: EW0167) as single dose (at the age of 40-year-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot number EW0158) on 15Apr2021 at 12: 50PM (at the age of 40-year-old) in the left arm for covid-19 immunisation and on 15Apr2021 her arm was numb on the side where she received the injection for more than 24 hours, it went numb pretty quickly after the first dose - then it was numb for about 24 hours. It went away completely in two days, but the patient was unsure if that is an adverse reaction. The patient experienced tongue was a little numb on 17May2021 with outcome of recovering , hard to swallow on 17May2021 with outcome of recovering , mouth feeling numb on 17May2021 with outcome of recovering , throat was closing up on 17May2021 with outcome of recovering , couldn't really speak on 17May2021 with outcome of recovering, coughing on 17May2021 with outcome of recovering, super shaky on 17May2021 with outcome of recovering, feet was also feeling numb on 17May2021 with outcome of recovering, face looked swollen on 17May2021 with outcome of recovering, chest tightness on 17May2021 with outcome of unknown, chest pain on 17May2021 with outcome of unknown, abnormal EKG on 17May2021 with outcome of unknown, her throat was a little sore on 17May2021 with outcome of unknown, tired on 17May2021 with outcome of unknown, doesn't have much of appetite on 20May2021 with outcome of unknown. Details as described as follows: Reports she went to sit in the waiting area, after 5 minutes she noticed her tongue was a little numb. She took her card out of her purse, and noticed it was a little hard to swallow, this was within about 8 to 10 minutes. She sat for another 5 minutes and then decided to ask about her tongue feeling numb and was taken to the nurses station. She told them about her tongue, and as she was talking her mouth was feeling more numb and it was getting harder to swallow. As the nurse was talking to her it was like she couldn't really speak. The nurse said this is way past Benadryl and called to another nurse for an Epipen. Caller states she started to cough as her throat felt like it was closing up. They jabbed her with the Epipen within 15 minutes of receiving the vaccine. She got some relief for a couple of minutes and then her body went back into the allergic response. They put her on the oxygen finger machine and then her throat started to close again. They gave another Epipen and then the ambulance arrived. She is unsure how long after she got the second Epipen that the ambulance arrived but it was no more than 5 minutes. They told her they had to call 911 right after giving the first Epipen. When the ambulance team came, she felt like she had novocaine in her mouth, her mouth was super numb and she was super shaky. They said the shaking was normal from an Epipen. Adds her feet were also feeling numb. She didn't know before that the shaking was from the Epipen. She was able to walk to the ambulance and her husband came and the med team was asking him if her face looked swollen and he said her face looked swollen. States her mouth felt like it was moving funny and she was exaggerating her speech trying to make her mouth move right. Adds she was still unaware that this could be an allergic reaction and was just trying to remain calm. At the site, she noticed her vitals on the machine and she saw 148/70 on the blood pressure. Adds it was about the same in the ambulance, it was 148/64. She was not able to collect any information about the Epipen other than they were yellow with a blue cap and they held it in her leg for three seconds. No lot or expiration date known for the Epipens. In the ambulance she was treated with Intravenous (IV) steroids and dose of Benadryl 50mg. As she was being transported to the hospital, she started to have chest pain. They did an EKG in the ambulance with no remarkable findings. Adds she has a follow up with her Primary Care Provider (PCP) today. When she arrived at the Emergency Room (ER) they monitored her for a couple of hours. She had another EKG at the ER and was told that it was normal so they released her. She has no product information for the steroids or the Benadryl that she received. No lot or expiration date known. When she got home everything was calming down. Her throat was a little sore and she was tired. The next morning her chest was still tight. She called the doctor who told her to just relax and come back to the ER if she has palpitations or difficulty breathing. Mentions she got the results of the EKG in ER now, and it said it was abnormal as compared to a previous EKG she had, and something about the T axis. Adds now she doesn't have much of appetite and her tongue still feels a little off. Caller interrupts the call to say her doctor just called and she needs to go. Unable to complete the report at this time. The outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.
40 2021-06-06 lymph node swelling, swelling face Pt reported difficulty breathing, swelling of face and throat, dizziness and weakness, pain, swellin... Read more
Pt reported difficulty breathing, swelling of face and throat, dizziness and weakness, pain, swelling and redness at injection site, sore throat, swollen lymph nodes, pain/tightness in chest, shortness of breath, headache, body aches, muscle aches, upset stomach, nausea, brain fog, fatigue, dizziness, and vertigo for six days after vaccination.
40 2021-06-06 lymph node swelling PAIN INTHE LEFT ARMS ,TICKLES AND I HAVE 2 DODULES ONE 5 MM AND ANOTHER 6 MM VERY SWALOW AND THE ARM... Read more
PAIN INTHE LEFT ARMS ,TICKLES AND I HAVE 2 DODULES ONE 5 MM AND ANOTHER 6 MM VERY SWALOW AND THE ARMA AND LEFT HAND IS VERY WEAK
40 2021-06-06 white blood cell count increased, swelling, swelling face, peripheral swelling, anaphylactic shock anaphylactic shock (fully body hives/extreme swelling of faces, neck, and limbs/ full body rash/pain... Read more
anaphylactic shock (fully body hives/extreme swelling of faces, neck, and limbs/ full body rash/painful itching/ feeling like a very intense burn) has lasted for 5 days causing hospitalization (has not gone away yet)
40 2021-06-07 lymph node pain, lymph node swelling Swollen Lymphnode in Right Breast - Axillary Lymph Group. Pain, Swelling
40 2021-06-07 oral herpes 3:30 am that night I got shaking fever/chills. I expected that but about 5 days after the shot the i... Read more
3:30 am that night I got shaking fever/chills. I expected that but about 5 days after the shot the inside of my mouth was in a lot of pain. A fever blister formed on my lower lip (left) and the inside of my mouth felt raw. It has been going on 2 days now- it?s hard to eat and hurts to talk. My gums are sore and I can feel raw spots on the roof of my mouth-like blisters.
40 2021-06-08 guillain-barre syndrome GBS syndrome (Guillain-Barre syndrome); muscle weakness in my lower extremity/ symptoms worsened ove... Read more
GBS syndrome (Guillain-Barre syndrome); muscle weakness in my lower extremity/ symptoms worsened over the next couple weeks; limiting her mobility/ inability to move around comfortably; unexpected falls; ]This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 40-years, on 29Mar2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history was none. The patient was not pregnant and was not pregnant at time of vaccination. The patient's concomitant medications were not reported. There was no any other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was experiencing some muscle weakness in her lower extremity, one week after her first shot of Pfizer on 29Mar2021. The symptoms worsened over the next couple weeks limiting her mobility resulting in unexpected falls. She could walk around the house and work sitting on her chair but was unable to climb up and down the stairs or run etc. During her annual check with doctor on Tuesday 20Apr2021 they figured out it was a side effect of the Covid vaccine, where in the antibodies from the vaccine were actually attacking her healthy peripheral nerves resulting in muscle weakness and inability to move around comfortably and was called the GBS syndrome (Guillain-Barre syndrome). Unfortunately she had already taken the 2nd shot on Monday 19Apr2021 (Batch/lot number: ER8734; Anatomical Location: Arm left), before her doc's appointment but fortunately they caught this in time to get her admitted to ER and do the tests to confirm GBS and her IVIG treatment started the very next day for 5 days. Date of start of events reported as 01Apr2021. Events resulted in hospitalization for 6 days. And treatment received. The patient underwent lab tests and procedures which included Nasal swab test with negative result on 20Apr2021. The patient was not diagnosed with COVID-19 prior to vaccination. Events outcome was not recovered. Information on the lot/batch number has been requested.
40 2021-06-08 lymph node swelling AFTER THE FIRST VACCINE: HERPES BASED BLISTERS IN MOUTH TO THE POINT THAT TAKING OR EATING WAS VERY ... Read more
AFTER THE FIRST VACCINE: HERPES BASED BLISTERS IN MOUTH TO THE POINT THAT TAKING OR EATING WAS VERY PAINFUL. SAW MY PA ON 03/25/21. VALTREX PRESCRIBED. BLISTERS WERE MUCH BETTER WITHIN 48HOURS. 03/27/21 UNEXPECTEDLY HAD MY PERIOD. I HAD JUST FINISHED UP MY PERIOD WHEN I HAD THE VACCINE ON 03/18/21. THIS PERIOD WAS UNLIKE ANY OTHER. THE BLEEDING WAS INCREDIBLY HEAVY, FULL OF CLOTS AND LASTED 9 DAYS. MY USUAL CYCLE IS 5. AFTER SECOND DOSE: ANOTHER UNEXPECTED PERIOD. THIS TIME NOT AS HEAVY, NOT AS MANY CLOTS AND DID NOT LAST AS LONG. SORE UNDERNEATH ARM AND LYMPH NODE UNDER ARM SWELLED.
40 2021-06-08 lymph node swelling The evening following the 2nd dose of covid 19 vaccine my arm was sore and I was tired. That night i... Read more
The evening following the 2nd dose of covid 19 vaccine my arm was sore and I was tired. That night it progressed into a fever of 104, severe body aches in almost all my joints, headaches, bradycardia and body chills. The fever was minimal reduced by switching Tylenol and Ibuprofen every few hours to about 102. Fever, chill and body aches started to subside in about 24 hours. Today I have sore throat, pressure/fluids in ears, slight chest pains and bradycardia, light headache and swollen lymph nodes in throat , inject site is still sore but most bothering is dizziness that is setting in.
40 2021-06-08 lymph node swelling left arm pain, axillary swelling for 4 weeks, difficulty lifting coffee cup initially, and heavier t... Read more
left arm pain, axillary swelling for 4 weeks, difficulty lifting coffee cup initially, and heavier things still a month later. Fingertips numb, different than prior carpal tunnel symptoms, which had resolved after surgery in 2013.
40 2021-06-10 white blood cell count increased Went on a walk on 6/8/21. Had high heart rate about 178 BPM) the entire time. After the walk, I co... Read more
Went on a walk on 6/8/21. Had high heart rate about 178 BPM) the entire time. After the walk, I could not breath well, the chest hurt, and I lost consciousness. Went to the ER.
40 2021-06-15 lymph node swelling Symptoms - Right eye swelling on June 10, rash on right side of face on June 11, swollen lymph nodes... Read more
Symptoms - Right eye swelling on June 10, rash on right side of face on June 11, swollen lymph nodes on June 12, face tingling on June 15. Initial Diagnosis - Stye on June 13 Later Diagnosis - Shingles on June 16 Initial Treatment - Prednisone and Clindamycin Later Treatment - Valacyclovir
40 2021-06-15 lymph node swelling Swollen armpit lymph nodes; This is a spontaneous report from a non-contactable other HCP (patient).... Read more
Swollen armpit lymph nodes; This is a spontaneous report from a non-contactable other HCP (patient). A 40-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3248) via an unspecified route of administration on 28Jan2021 at 15:15 in left arm as a single dose for covid-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccines within four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications received in two weeks included multi vitamin and vitamin c (VITAMIN C [ASCORBIC ACID]) both taken for an unspecified indication, start and stop date were not reported. The patient previously took morphine and experienced drug allergy. The patient experienced swollen armpit lymph nodes on 30Jan2021 at 10:00. Patient did not receive any treatment. The outcome of the event was not recovered. No follow up attempts are possible. No further information is expected.
40 2021-06-16 lymph node swelling swollen glands in her throat; dizzy/lightheaded; heart palpitations; inflammation on both sides of t... Read more
swollen glands in her throat; dizzy/lightheaded; heart palpitations; inflammation on both sides of the back of her tongue; This is a spontaneous report from a contactable consumer (patient herself). A 40-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ENG203) intramuscularly on 25Feb2021 (at the age of 40-year-old) at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient reported that the first day and a couple of days after (not clarified further) she had swollen glands in her throat, inflammation on both sides of the back of her tongue and lightheaded. These symptoms lasted a couple of days. The following week she was dizzy and had heart palpitations. She informed that "heart stops sometimes" (as reported) and she was experiencing that on and off. The caller was apprehensive about the second dose and wanted to know if her symptoms were an allergic reaction. The patient did her normal routine blood work with her doctor, unsure whether it was before or after the shot: it was normal. Tongue and throat were improving, reported to be resolved (not clarified further). Outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
40 2021-06-22 lymph node swelling Chest pain for week and then intermittent Elevated Heart rate ongoing Shortness of breath ongoing
40 2021-06-22 lymph node swelling Severe left arm soreness that developed into lymphadenopathy-significantly swollen armpit and pain i... Read more
Severe left arm soreness that developed into lymphadenopathy-significantly swollen armpit and pain into the left breast. Followed by severe abdominal pain that worsened over 5 days with significant nausea.
40 2021-06-24 lymph node swelling Developed a swollen lymph node under right arm.; itchy throat; Started with itchy nose; cough; nause... Read more
Developed a swollen lymph node under right arm.; itchy throat; Started with itchy nose; cough; nausea; headache; Temp 99.5.; heavy chest; hard breathing; Body aches occurred overnight; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL22613), via an unspecified route of administration in the right arm on 18Mar2021 at 10:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, depression/anxiety, and heart burn. Concomitant medications received within 2 weeks of vaccination included levothyroxine (MANUFACTURE UNKNOWN), fluoxetine (MANUFACTURE UNKNOWN), norgestimate and ethinyl estradiol (TRI-LO SPRINTEC) and omeprazole (OMEPRA), all for unknown indications from unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration in the right arm on 25Feb2021 at 12:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 18Mar2021 at 16:00, the patient experienced itchy nose and throat that developed into cough, nausea, and headache. Temp 99.5 and developed into heavy chest and hard breathing. Body aches occurred overnight and into the morning of 19Mar2021. Coughing, nausea, and body aches continued, and developed a swollen lymph node under right arm. The patient did not receive treatment for the reported adverse events. The clinical outcome of itchy nose, itchy throat, headache, temperature 99.5, heavy chest, hard breathing, swollen lymph node under right arm were recovering, and body aches, nausea, cough was not recovered. No follow up attempts are needed. No further information is expected.
40 2021-06-24 lymph node swelling Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast/Lymph n... Read more
Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast/Lymph nodes enlarged on right neck \extremely painful even without touching; Right leg: joint pain, shooting pain here and there along the leg, hip pain, leg muscle weakness; Right leg: joint pain, shooting pain here and there along the leg, hip pain, leg muscle weakness; Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast; Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast; difficult swallowing due to the pain; Right ear painful, feeling like too much pressure on it; Right ear painful, feeling like too much pressure on it; Right head painful, excruciating pain; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Ew0185 and Expiry date: Unknown), via dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took penicillin [penicillin nos] for drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient was not diagnosed with covid 19 and has not been tested for COVID-19 Since the vaccination. On 21May2021, the patient experienced right leg: joint pain, shooting pain here and there along the leg, hip pain, leg muscle weakness; lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast; lymph nodes enlarged on right neck (multiple places: under chin, above collar bone, beside right ear), extremely painful even without touching, difficult swallowing due to the pain; right ear painful, feeling like too much pressure on it and right head painful, excruciating pain. The patient was not received any treatment for the events. The outcome of events was not resolved.
40 2021-06-24 peripheral swelling This is a spontaneous report from a contactable consumer, the patient. A 40-years-old non pregnant f... Read more
This is a spontaneous report from a contactable consumer, the patient. A 40-years-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: ER8734) via an unspecified route of administration in the left arm on 08Apr2021 at 08:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included palindromic rheumatism and sulfonamide allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number; ER8727) via an unspecified route of administration in the left arm on 18Mar2021 at 08:15 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient was not tested for COVID-19. The patient experienced swelling in ankles and in feet most severe on left side on 08Apr2021 at 17:00. The patient did not receive any treatment for the events. The clinical outcome for events swelling in ankles and in feet was resolved on unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
40 2021-06-29 lymph node swelling Dose 1- 03Feb2021 and Dose 2- 19Mar2021; Sore arm at injection site; Swollen lymph node left armpit;... Read more
Dose 1- 03Feb2021 and Dose 2- 19Mar2021; Sore arm at injection site; Swollen lymph node left armpit; sore underarm; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via unspecified route of administration in the left arm on 19Mar2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic back pain (chronic lower back pain) and latex allergy. Concomitant medications included oxycodone and acetaminophen (MANUFACTURER UNKNOWN) and etonogestrel; ethinyl estradiol (NUVARING) from unknown date for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via unspecified route of administration in the left arm on 03Feb2021 at 16:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Mar2021 at 21:00, patient experienced sore left arm at injection site, swollen lymph node at left armpit, and and sore underarm .The patient received first dose on 03Feb2021 and second dose on 19Mar2021 (Inappropriate schedule of vaccine administration). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome for sore left arm at injection site, swollen lymph node at left armpit, and and sore underarm and inappropriate schedule of vaccine administration was unknown. No follow-up attempts are needed. No further information is expected.
40 2021-06-29 peripheral swelling, lymph node swelling significant swelling (may be tennis ball size) in my shoulder area; lymph node, but seemed furtherdo... Read more
significant swelling (may be tennis ball size) in my shoulder area; lymph node, but seemed furtherdown my neck than that. It wastender to touch and sore; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 17Mar2021, at 10:30 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication within two weeks of vaccination included trinessa (MANUFACTURER UNKNOWN) and claritin (MANUFACTURER UNKNOWN), both for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021, at 18:00, the patient had significant swelling (maybe tennis ball size) in her shoulder area on the side of the vaccination. It was reported that maybe a lymph node, but seemed further down her neck than that which was tender to touch and sore. Therapeutics measures included iced the area for events swelling arm and swollen lymph nodes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of swelling arm and swollen lymph nodes was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
40 2021-06-30 axillary mass Left arm (where shot was given) continues to ache and be somewhat weak through left hand more than a... Read more
Left arm (where shot was given) continues to ache and be somewhat weak through left hand more than a week after the vaccine. Feel a lump and tenderness in left underarm. Tenderness has spread to chest near collar bone.
40 2021-06-30 swelling face Felt faint and body shaking immediately, after that sat during 15 min observation period. Had some... Read more
Felt faint and body shaking immediately, after that sat during 15 min observation period. Had some more body shaking and feeling faint. Thought it was a normal vaccine reaction. Went to the car w/daughter after observation period. As she was leaving the parking garage she started having palpitations, was holding her chest, starting "doing breathing techniques." Throat then "dried out," drank water, then after a while it was hard to drink the water. Daughter told her that her face was swollen. Pulled the car over, had daughter call family to come and help, daughter drove her to a pharmacy where they purchased Benadryl. Patient took the Benadryl. Family arrived, then swelling subsided. Then when they got home she had vomiting and diarrhea. All symptoms lasted about 5 hrs. Vomiting and diarrhea continued into 2nd day, then after that everything completely resolved. Next day she called the VA to report what happened, she was advised to have come back in. Symptoms: palpitations, throat and face swelling vaccine administration time: 11:00am symptoms started: 11:01am symptoms ended: next day at 6pm
40 2021-06-30 swelling Swelling , sick and in bed, then found a large rash on left breast, small boil , covid arm, chills l... Read more
Swelling , sick and in bed, then found a large rash on left breast, small boil , covid arm, chills low energy for 4 days
40 2021-07-01 swelling 20 min after shot, upper nasal passage, lips and tongue began swelling. I was driving from vaccine c... Read more
20 min after shot, upper nasal passage, lips and tongue began swelling. I was driving from vaccine clinic, stopped at pharmacy to get Benadryl (took it ~60min after shot). Called doctors office, and had appt ~90 min after shot. Benadryl relieved symptoms, doctor recommended another dose of Benadryl and switching to non-drowsy 24 hr allergy medicine for 48 hours. I followed those directions. No other anaphylactic reaction. Post shot, dairy intolerance discovered and still unable to eat dairy after almost 2 months.
40 2021-07-04 lymph node swelling Presented to hospital on 6/19 with severe frontal headache, mild speech changes, and motor deficits ... Read more
Presented to hospital on 6/19 with severe frontal headache, mild speech changes, and motor deficits without fevers, shortness of breath, chest pain, or neck rigidity.
40 2021-07-06 lymph node swelling Symptoms Shot January 10 Sore arm Fever headache cough 7 days Brain fog persistent headaches No pe... Read more
Symptoms Shot January 10 Sore arm Fever headache cough 7 days Brain fog persistent headaches No period February lymph nodes under the armpit 3 days Persistent headaches No period March Persistent headaches No period One day of blood clots Er visit for upper gi severe pain ct clear April Headaches worsening No period May Headaches worsening No period Tremors in right hand ER VISIT migraine meds given no change June Headaches worsening No Period Stuttering and speech difficulty 6 10 15 16 dizziness and vomiting 6 10 difficult with walking Pain behind eyes moving side to side and up and down 6/19 carbonated sodas are flat can?t feel Carbonation in my mouth July Worsening head pain Consistent stutter Intermittent problems with walking July 5th hard time gripping items and equilibrium off. Treatments. EEG shows diffuse brain dysfunction, VERS shows optic nerve information. Intercranial pressure increased. No changes still testing
40 2021-07-07 swelling face 1st occurence: Left collarbone, shoulder and armpit pain. Burning/ throbbing pain that lasted 12 hou... Read more
1st occurence: Left collarbone, shoulder and armpit pain. Burning/ throbbing pain that lasted 12 hours. Nothing helped - OTC pain relivers, heating pad, BIO-Freeze, Cold pack, hot shower, cold shower, movement Extreme pain that caused sleeplessness 2nd Occurrence on 6/25/2021 Same symptoms as above - nothing helped. Extreme burning/ throbbing pain left side of face was swollen and skin near collar bone was swollen - this lasted 2 days after pain stopped Still experience soreness in shoulder
40 2021-07-08 high blood cell count 40-year-old female with history of occasional headaches and Hashimoto?s thyroiditis (euthyroid not o... Read more
40-year-old female with history of occasional headaches and Hashimoto?s thyroiditis (euthyroid not on medication) who presented for evaluation of a new purpuric rash on her gluteal region of unknown duration. Twenty days prior to presentation, she received the second dose of the Pfizer?BioNTech BNT16B2b2 mRNA vaccine, reporting mild fatigue and myalgias lasting 2 days post injection. She developed a purpuric rash on her buttocks that was consistent with Henoch-Schönlein purpura. Rheumatology, hematology, and fertility doctors agreed the rash was consistent with early-stage HSP triggered by Pfizer?BioNTech BNT16B2b2 mRNA vaccination. Given lack of systemic involvement, she was asked to monitor symptoms. Rash resolved within a week.
40 2021-07-08 oral herpes Patient states that she developed 3 cold sores on the right side of her mouth that started 1 to 2 da... Read more
Patient states that she developed 3 cold sores on the right side of her mouth that started 1 to 2 days after 1st covid shot.
40 2021-07-09 peripheral swelling Walking and was feeling fine but towards evening pain in my right Achilles tendon ankle on heel. Pai... Read more
Walking and was feeling fine but towards evening pain in my right Achilles tendon ankle on heel. Pain got worse. I contacted doctor's office; put me in a cam boot but then it was feeling worse, and I went again, and he did an MRI, and I was in that for eight weeks. I was in the boot until the end April. From the 10th and then 8 weeks beyond that. Past week I was walking, and I think I have a tear in my left calf now, in my other calf, and it's still sore. I'm assuming I tore something. It's a little swollen and I'm limping around. I am going to continue to watch it. I had lab work done and all of that seemed fine. No inflammatory markers showing. They are watching me for any kind of auto-immune condition because I've had positive and negative ANA tests and Rheumatoid Factor results; will be high at times and then it goes back to normal, it fluctuates. So, they are watching it. I'm still sore on the left calf. Note: In May, I think, I had the Gardasil vaccine; the third one of the series, need to confirm the exact date.
40 2021-07-10 oral herpes, peripheral swelling loss of smell; Loss of taste; High fever; chills; sweats; Aches; fatigue; Swollen hard arm; Broke ou... Read more
loss of smell; Loss of taste; High fever; chills; sweats; Aches; fatigue; Swollen hard arm; Broke out with fever blisters nose mouth and lips; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via the unspecified route of administration in the right arm on 24Mar2021 at 13:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks of the COVID vaccination. The patient did not receive any medications within two weeks of the COVID-19 vaccination. On 25Mar2021 at 03:00, the patient experienced high fever, chills, sweats, aches, fatigue, swollen hard red arm for five-plus days, fever blisters in nose mouth and lips. On 28Mar2021 (day 5), the patient experienced the loss of smell and taste. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events high fever, chills, sweats, aches, fatigue was resolved in 48 hours on 27Mar2021; while the events of the swollen hard red arm, fever blisters, loss of smell and loss of taste was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
40 2021-07-10 peripheral swelling My arm swelled like a big knot, bruised and hardened. I felt woozy and out of it like not alert for ... Read more
My arm swelled like a big knot, bruised and hardened. I felt woozy and out of it like not alert for 3 days already i would also sweat and feel weak like passing out, i had fever spikes of 100 degrees for 3 days and had to take tylenol plus had headpain, confusion. I felt nsuseated. I had flu chills in the first 24 hours and aches for 3 days the wooziness and disoriented effects lasted 5 days and came in waves. I took tylenol and stayed home from work
40 2021-07-12 c-reactive protein increased I was 40 years old and received both doses of the Pfizer vaccine and not only has my body hurt more ... Read more
I was 40 years old and received both doses of the Pfizer vaccine and not only has my body hurt more with my fibromyalgia, but I have been in a CONSTANT flare since the shot. I have had Interstitial Cystitis since age 23 and the only thing I did differently was to take the covid vaccine, not realizing it is gene therapy and an mRNA vaccine. I usually have no flares in the summer. Ragweed and spring allergies tend to mess me up, but summer is usually pretty good.
40 2021-07-12 peripheral swelling My left hand became swollen for about 4 days starting on the day of the first injection. Once that s... Read more
My left hand became swollen for about 4 days starting on the day of the first injection. Once that subsided, my entire arm, hand, and fingers felt sprained and bruised. And my nerve endings in my palm and fingers were firing constantly. That lasted for a few weeks. Once the "sprained" feeling subsided and I had more mobility in my art/wrist, the nerve pain remained. I received this injection 4/28/21; it's now 7/13/21 and I still have nerve pain in my forearm, hand and fingers that moves around/is worse in some areas than others at different times. It feels like a pins and needles sensation, sometimes burning, sometimes aching, sometimes like it feels when you hit your funny bone. I have been told I have peripheral neuropathy. I don't know if it's from the vaccine itself or if the person who administered it hit a nerve.
40 2021-07-13 c-reactive protein increased Chills, sweats, nausea, headache, chest pain with deep inspiration, contacted 1 week after vaccinati... Read more
Chills, sweats, nausea, headache, chest pain with deep inspiration, contacted 1 week after vaccination. Continued for another week, contacted clinic. Recommended ER, patient did not go. Reached out to her cardiologist who ordered labs and chest xray. CMP, CBC and Chest xray all normal on 4/12/21. Reached out after she returned from vacation and reported lingering cough. Rx'd Cheratussin and Albuterol inhaler. Patient was recommended respiratory clinic, instead she made her own appt to go to ENT. Patient had also reported worsening GERD symptoms- upset stomach and throat clearing- referred to her GI specialist who manages her GERD/Hiatal hernia. ENT saw patient on 4/30/21- dx'd with cough, reactive airway, GERD, globus sensation. Rx'd- Advair- 2 puffs BID, Nasal saline spray, Allegra 180 mg- daily, continue Protonix and referred back to GI. Called 5/5- reported mid right back pain that woke her up on Saturday AM (4 days prior). Recommend ER due to pain awakening her and also to follow up with her GI MD. She reports her GI ordered an Ultrasound but couldn't see her until August. Went to ER on 5/5 with dx of right sided thoracic pain. Sent home with no Rx, recommend NSAIDs, ice/heat, lidocaine patches. Patient reached out on 5/18 to discuss US results- informed there was mild splenomegaly. Continued with cough, upset stomach, back pain. PCP received US results on 5/24. Patient recommended to come in to see PCP for further management. Saw PCP on 6/2/21- Labs ordered today are ANA screen, BNP, CRP, CMP, COVID IgG, UA macro/mirco and culture, CMV antibody, EBV panel, D-Dimer, CBC, hepatitis panel, HIV, LDH, lipase, Quantiferon, TSH, RF and ESR. Referred to respiratory clinic- informed patient it was Pertussis- placed on Azithromycin. PCP switched RX to Levaquin. Healthline reached out to patient for elevated D-Dimer- patient refused ER. 6/9/21- CT- renal infarct, splenic infarct 6/10/21- Admitted. Bacterial endocarditis, renal and splenic infarct, ended with open heart surgery, valve replaced, replaced pacemaker
40 2021-07-17 lymph node pain Painful lymph node in left armpit.; This is a spontaneous report from a contactable consumer, the pa... Read more
Painful lymph node in left armpit.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 27Mar2021 at 13:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not available (n/a). The patient did not had allergy to any medications, food, or other products. Concomitant medications included quetiapine (MANUFACTURER UNKNOWN), MAXI-HAIR PLUS, D3 (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), and LINZESS all taken for an unknown indication, from unknown dates. The patient previously received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration in the left arm on 06Mar2021 at 13:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 28Mar2021 at 11:00, the patient experienced painful lymph node in the left armpit. The patient did not receive any treatment for the adverse event. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event painful lymph node in the left armpit was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
40 2021-07-17 swelling face, peripheral swelling Swollen eyes, face, lips, hands, left leg and ankle; Swollen eyes, face, lips, hands, left leg and a... Read more
Swollen eyes, face, lips, hands, left leg and ankle; Swollen eyes, face, lips, hands, left leg and ankle; Swollen eyes, face, lips, hands, left leg and ankle; Swollen eyes, face, lips, hands, left leg and ankle; Swollen eyes, face, lips, hands, left leg and ankle; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0177), dose 1 via an unspecified route of administration, administered in left arm on 30May2021 at 12:00 (at the age of 40-years-old) as dose 1, single for COVID-19 immunization. Medical history included orange allergy. The patient was not pregnant at the time of vaccination. The patient had not been tested for COVID-19 nor before neither since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks prior to the COVID-19 vaccine. No concomitant medications was reported. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient experienced swollen eyes, face, lips, hands, left leg and ankle on 30May2021 at 17:00. Treatment include Benadryl. The outcome of the events were not recovered. Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected. Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.
40 2021-07-18 peripheral swelling, lymph node swelling Swollen lymph node under right arm. My entire arm was sore to my finger tip it felt as if my circula... Read more
Swollen lymph node under right arm. My entire arm was sore to my finger tip it felt as if my circulation was being cut off in my arm and it lasted about 48hrs. My under arm is still swollen and sore. I did have all the other side affects, fever, chills, dizzy, muscle aches and fatigue.
40 2021-07-19 lymph node swelling Within 2 hours I could not keep my eyes open and had to go to sleep. I woke up the next morning and ... Read more
Within 2 hours I could not keep my eyes open and had to go to sleep. I woke up the next morning and my head was killing me. My glands in my neck were swollen, my ears hurt, my tongue was swollen and had sores on the sides of it. I was severely fatigued, running a low grade fever and could barely move my left arm. These symptoms lasted for a couple of days and then dropped off. Then, exactly one week later I woke up and could barely move my left arm. My lymph node under my armpit was swollen to the size of a baseball and was in excruciating pain. The injection site was also red and swollen and had a rash going down my arm as well. This lasted for about a week before going away. After the second dose, about 2 hours after receiving the shot, I had to lay down and take a nap. I got up about 2 hours later and was already feeling ill and running a low grade fever. I went to bed and woke up at 3:00 am in a ridiculous amount of pain. My whole entire body was cramping like I had not had water to drink in a week, then I was having sharp shooting stabbing pains throughout my whole body. My whole body felt like I had been run over by a bus. Every muscle hurt, I was sweating, freezing, running a temp, my head felt like it was about to explode. The lymph node in my left arm swelled up instantly and my arm hurt so bad I could not move it. I was in and out of sleep and when I would wake up I would have to change my clothes because they were drenched in sweat and having to lay a towel down on the bed because it was wet but I didn't have the energy to change the sheets. This went on for FOUR days. I was on the verge of going to the ER on day three but after being helped out of bed and into a hot bath, the pain in my body started easing up. I had COVID in March of 2020 and this second shot was ALMOST as bad as when I had COVID. The only difference is I was sick for about 4 weeks and my lungs were really bad when I had COVID. The shot did not affect my breathing.
40 2021-07-25 swelling Patient stated that 4 or 5 hours after receiving the vaccine she started feeling itchiness in her bo... Read more
Patient stated that 4 or 5 hours after receiving the vaccine she started feeling itchiness in her body. She has spots on her body that look like mosquito bites. She is still having this reaction.
40 2021-07-27 lymph node pain Soreness and swelling at injection site; Soreness and swelling at injection site; Red spot at exact ... Read more
Soreness and swelling at injection site; Soreness and swelling at injection site; Red spot at exact injection site; Soreness in lymph nodes at arm pit.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 15:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 23:00 the patient experienced soreness and swelling at injection site (7 days after the first injection), red spot at exact injection site and soreness in lymph nodes at arm pit. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events soreness and swelling at injection site, red spot at exact injection site and soreness in lymph nodes at arm pit were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
40 2021-07-28 swelling face 1104 -Vaccine administer IM in L arm. 1110- PT states to complain of having something in her throat.... Read more
1104 -Vaccine administer IM in L arm. 1110- PT states to complain of having something in her throat. Denies having any SOB, chest tightness, itching, and no hoarseness. 1115- PT is clearing her throat more and states that she feels like she has to keep clearing her throat more and started to have Hoarseness denies having SOB but states that she is having a harder time breathing when positioning her head in certain ways. 1118- Minimal facial swelling noted clearing throat more often pt continues to talk to staff. Denies having SOB or chest tightness. Doctor notified of pt's symptoms and instructed to give Epi-Pen NOW. Epi-PEn(Lot #0FM407 exp: 02/2022) administered to Left Thigh by LPN. Pt tolerated and continues to talk to staff. 1120- Doctor in Room evaluating patient. Doctor instructed to continue monitoring in room for the remainder of 30 minute wait and advised patient that she could return back to work since pt works in the hospital. PT voiced understanding. Pt continues to deny SOB and chest tightness. 1125- PT states that she can tell her throat is starting to feel better states that she doesn't feel like she has to continue clearing throat. Continues to communicate with staff and continues denying any SOB. 1130- PT continues to states that feels like she is improving. Facial swelling has gone down. Continues to communicate and denies having and SOB and chest tightness. 1135- PT's 30 minute wait is up and Pt continues communicating with staff. Denies SOB states that she feels somewhat better. Informed patient that she could continue to be monitored by immunizations RN but pt denies and verbalized that ''Dr. said I could go back to work''. Informed patient that if symptoms do not improve and if she starts to have SOB, difficulty swallowing, swelling in throat or tongue to seek immediate attention at the ER. Pt verbalized understanding and ambulated out of area.
40 2021-07-29 swelling toe continues to be red and swollen; Moderate/severe pulsing pain in left big toe; This is a spontan... Read more
toe continues to be red and swollen; Moderate/severe pulsing pain in left big toe; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: PFIZER EP7533) via an unspecified route of administration in the left arm on 03Apr2021 at 16:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included toe injury on Sep2020 about 7 months ago. The patient had no known allergies. Concomitant medications included valaciclovir (VALACYCLOVIR) and PNR (unspecified) for unknown indication on unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 03:30 the patient experienced moderate/severe pulsing pain in left big toe and toe was red and swollen. It was reported that after the first night of extreme pain, the pain had subsided, but the toe continues to be red and swollen, which it was not prior to the vaccine. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events pulsing pain in left big toe and toe continues to be red and swollen were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
41 2021-01-03 swelling face 12/19/2020-12/20/2020 only experiences soreness of left arm where vaccine received. Woke up early mo... Read more
12/19/2020-12/20/2020 only experiences soreness of left arm where vaccine received. Woke up early morning 12/21/2020 with moderate swelling of eyelids, face, lips that progressed over several hours before seeking care at Hospital ED. Received IV Benadryl and IV solumedrol. Prescribed oral prednisone dose pack to start next day. Symptoms mostly resolved by that evening.
41 2021-01-04 lymph node swelling after the vaccination i had a high fever, body aches and and my tonsils were swollen causing me to m... Read more
after the vaccination i had a high fever, body aches and and my tonsils were swollen causing me to miss work
41 2021-01-04 lymph node swelling Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash ... Read more
Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash on flexural of both arms, started with just left then progressed to both arms 12/27; achy feeling still; "gross feeling;" swollen lip with blister, started 1/3; left supraclavicular lymph node swollen
41 2021-01-04 swelling face "Pfizer-Bio-Tech COVID-19 Vaccine EUA" Provider contacted an individual in regards to an individual ... Read more
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Provider contacted an individual in regards to an individual who received the Covid-19 Vaccine on 12/19/2020. The individual reported sand paper face rash and full swollen face that started 3 days after receiving the vaccine (1/1/2021). Individual reported that she had Botox and facial fillers on 12/15/2020. This event was an unwitnessed by the staff at Health Department. The event was reported to Epidemiologist.
41 2021-01-05 lymph node swelling, lymph node pain swollen, very painful lymph node in right arm pit that began about 36 hours after receiving vaccinat... Read more
swollen, very painful lymph node in right arm pit that began about 36 hours after receiving vaccination and lasted for about 48 hours
41 2021-01-06 anaphylactic reaction Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then i... Read more
Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then itchy throat, probably about an hour, as that got worse throat started swelling. Took 50mg prednisone 2 benadryl and albuterol inhaler. Breathing got better and hives went away but still had swollen throat and took pepcid. Headache afterwards but that's typical of an allergic reaction. I can't be sure it was from the vaccine or not but nothing I did yesterday would normally trigger that reaction
41 2021-01-06 lymph node swelling Swollen clavicular lymph node, arm soreness, body aches. Taking tylenol and motrin for arm soreness... Read more
Swollen clavicular lymph node, arm soreness, body aches. Taking tylenol and motrin for arm soreness and body aches with improvement.
41 2021-01-06 lymph node swelling Fever 104, chills, nauseas, swollen lymph's armpits, severe headaches
41 2021-01-07 lymph node swelling, lymph node pain I have developed a swollen/painful lymph node under my Lt armpit area.
41 2021-01-07 lymph node swelling Ipsilateral anterior axillary swelling/lymphadenopathy, beginning ~24 hours after administration, li... Read more
Ipsilateral anterior axillary swelling/lymphadenopathy, beginning ~24 hours after administration, limiting L arm ROM x3 days. I was unable to lower my arm fully, and had significantly impaired movement due to pain and swelling. It is Improving as of report date, but still present (ROM essentially back to normal, only tender to palpation)
41 2021-01-07 lymph node swelling Swollen supraclavicular lymph node left side
41 2021-01-07 swelling face sand paper face rash and full swollen face; sand paper face rash and full swollen face; This is a sp... Read more
sand paper face rash and full swollen face; sand paper face rash and full swollen face; This is a spontaneous report from a contactable other healthcare professional (HCP). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EH9899) via intramuscular on arm left as the first dose on 19Dec2020 at single dose for COVID-19 immunization. The patient had Botox and facial fillers on 15Dec2020. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. And it was unknown whether the patient had been tested for COVID-19 since the vaccination. The patient had sand paper face rash and full swollen face that started on 01Jan2021 (also reported as 3 days after receiving the vaccine). The events were reported as non-serious. It was unknown whether treatment was received for the events. The outcome of the events was unknown.
41 2021-01-07 swelling, anaphylactic reaction anaphylaxis with immediate whole body swelling. Epinephrine 0.3mg IM administered
41 2021-01-07 swelling Axillary swelling.; Neck and hand pain in the injection arm.; Neck and hand pain in the injection ar... Read more
Axillary swelling.; Neck and hand pain in the injection arm.; Neck and hand pain in the injection arm.; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular in right arm on 28Dec2020 at single dose for COVID-19 immunization. The vaccine was administered at workplace clinic. There were no medical history and concomitant medications. The patient has no known allergies. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced axillary swelling, neck and hand pain in the injection arm on 29Dec2020. No treatment was given for the events. The outcome of the events was not recovered. Information on the Lot/batch number has been requested.
41 2021-01-07 swelling Right forearm pain, slight swelling, and neuropathy (burning pain) began 12/22 in the evening and la... Read more
Right forearm pain, slight swelling, and neuropathy (burning pain) began 12/22 in the evening and lasted until Saturday 12/26 - responded and improved with acetaminophen and ibuprofen; slight fatigue x 2 day and some slight chills
41 2021-01-08 swelling Angioedema Tongue Tingling Narrative: Tingling decreased after 20 mins.
41 2021-01-08 oral herpes Pfizer-BioNTech COVID-19 Vaccine- Woke up at 01:30 with extreme chills, body aches & fever 101.8. To... Read more
Pfizer-BioNTech COVID-19 Vaccine- Woke up at 01:30 with extreme chills, body aches & fever 101.8. Took 2 Tylenol & woke up at 0400 with a fever of 102.6, chills, body aches & horrible headache. I also had no appetite, nausea & developed fever blisters on lower lip. Lasted until Tuesday 12/29 & ended up going to the ER because the headache was so horrible & would not go away.
41 2021-01-08 swelling face 2nd Pfizer vaccine was given on Thursday Jan. 7th around 1240pm. That evening I experienced expecte... Read more
2nd Pfizer vaccine was given on Thursday Jan. 7th around 1240pm. That evening I experienced expected muscle aches, chills, headache, fatigue. The next evening, Jan 8th I experienced chest pain which felt like heartburn or gastritis (which I do not typically have) in addition to the muscle aches, chills and headache returning. The morning of Jan 9th I woke up with a swollen face in addition to ongoing body aches, fatigue and headache and took 50mg of Benadryl and went to urgent care for evaluation.
41 2021-01-08 swelling Itching palms ears head and eyes itching then escalated to itching all over and swelling
41 2021-01-09 lymph node swelling Fatigue. Severe axillary lad and supraclavicular lad. Myalgia. Fever
41 2021-01-09 oral herpes Cold sores broke out on lower lip 1 day after given injection. Abreva cream applied twice per day. T... Read more
Cold sores broke out on lower lip 1 day after given injection. Abreva cream applied twice per day. The lesion was not changed.
41 2021-01-10 lymph node pain I received my first vaccine 12/22/2020 at 3:45pm. My right arm was sore like I would have expected a... Read more
I received my first vaccine 12/22/2020 at 3:45pm. My right arm was sore like I would have expected and everything else was fine, until 12/31/2020. My left upper thigh had a burning feeling around the outer part and in the goin on that thigh a painful lymph node. That afternoon I had a burning sensation on my left butt cheek. When I looked I noticed a very small rash with blisters. I waited through the weekend because I knew the OBGYN was not open. I called first thing Monday morning and made an appointment as soon as they could see me which was the next day (1/5/2021)at 3:30pm. The doctor took samples and sent them to the lab for testing. The test was positive for shingles. I am now taking valtrex for shingles.
41 2021-01-10 lymph node pain Pfizer BioNTech Covid 19 vaccine EUA- Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-... Read more
Pfizer BioNTech Covid 19 vaccine EUA- Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-- fever 101.3, body aches, chills, extreme fatigue, sore throat, dizziness, sinus congestion , abdominal pain, tender lymph nodes in neck HA and pain at injection site.
41 2021-01-10 lymph node swelling lymph node swelling Narrative: Swollen lymph node under left arm
41 2021-01-10 swelling face cheeks were swollen; when I brushed my teeth, i felt a severe burning sensation inside my mouth and ... Read more
cheeks were swollen; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; so tired; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the left arm on 26Dec2020 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included allergic reaction with known allergies to sulfa, seafood. Concomitant medications included acetylsalicylic acid/caffeine/salicylamide (EXCEDRIN) and paracetamol (TYLENOL). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, "I just finished a night shift from work and got home on 02Jan2021 around 07:45 when I brushed my teeth, I felt a severe burning sensation inside my mouth and the inside of my mouth started to swell. I didn't think much of it since I was so tired but then woke to get ready to work then my mouth and cheeks were swollen (02Jan2021 at 16:00) and barely could open my mouth." No treatment was provided for the events burning mouth, mouth swelling, cheeks were swollen and so tired. The outcome of the events burning mouth, mouth swelling, cheeks were swollen and so tired was not recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
41 2021-01-11 lymph node swelling worsening of the rash developed tender/swollen supraclavicular lymph nodes
41 2021-01-11 lymph node swelling 12/18/2020 Night in pain on right side of arm and she had a big ball under the arm pit the size of... Read more
12/18/2020 Night in pain on right side of arm and she had a big ball under the arm pit the size of a base ball and ER and your lynodes had swollen. Gave you IVProphen and Tylneol Took a week in a half for swollen to go down.
41 2021-01-11 lymph node swelling Swollen lymph node in left armpit; This is a spontaneous report from a contactable other healthcare ... Read more
Swollen lymph node in left armpit; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730), via an unspecified route of administration on the left arm on 04Jan2021 at 15:45 at a single dose for COVID-19 immunization. The patient has no medical history and no known allergies. The patient's concomitant medications were not reported. The patient experienced swollen lymph node in left armpit on 05Jan2021 at 16:00. No treatment administered for the event. The patient did not have other vaccine in four weeks or other medications in two weeks. The patient also did not have Covid prior vaccination and had not tested for Covid post vaccination. The event was resolving.
41 2021-01-12 lymph node swelling, peripheral swelling Patient complained of headache, upset stomach, diarrhea, very tired all day 1/8/21, left arm swellin... Read more
Patient complained of headache, upset stomach, diarrhea, very tired all day 1/8/21, left arm swelling with pain from forearm to shoulder. Woke on Saturday, 1/9/21 with enlarged/swollen lymph nodes under left arm, had headaches throughout the weekend. By Monday, 1/11/21 most symptoms had resolved with the exception of some arm soreness.
41 2021-01-12 lymph node swelling, swelling pain and swelling right clavicular area and right side of neck Narrative: Employee stated she devel... Read more
pain and swelling right clavicular area and right side of neck Narrative: Employee stated she developed pain and swelling in the right clavicular area on 1/10/21 and used warm compresses but noticed swelling and pain in the right side of neck on 1/11/21. no sob, no fever
41 2021-01-12 swelling face, lymph node swelling 24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the ... Read more
24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the injection I had been getting headaches almost daily, mostly on my right side of my head. On Dec. 5, 2021 I noticed I was getting a sore eyebrow. Later that evening ok noticed swollen lymph nodes throughout my scalp, face, ear, jaw, neck and chest. My eyebrow also started to swell and was slightly pink. When the swelling was worse the next day - I went to urgent care and saw A doctor that diagnosed me with facial cellulitis. After a couple days my eye was not getting any better and started to itch severely. Called to urgent care over the weekend and takes to one of the providers who said to use cold compresses and elevate my head as much as I could. On Dec. 11, 2021 I called back to the provider I had seen on Dec. 6 - he told me he believed I had developed shingles and to go to the eye doctor that day. I saw a doctor on Dec. 11 & was diagnosed with shingles. They started me on antivirals along with the antibiotics they had prescribed on Dec. 6.
41 2021-01-13 anaphylactic reaction Systemic: Anaphylaxis-Mild, Systemic: feelt tingling and warm sensation inside the body, felt tightn... Read more
Systemic: Anaphylaxis-Mild, Systemic: feelt tingling and warm sensation inside the body, felt tightness in throat; symptoms lasted 0 days
41 2021-01-13 swelling severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of brea... Read more
severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; This is a spontaneous report from a contactable nurse (reporting for herself). A 41-year-old non-pregnant female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), both via an unspecified route of administration in the left arm, the first dose on 16Dec2020 09:00 (lot number: EH9899) and the second dose on 08Jan2021 07:15 (lot number: EL0140), both at a single dose for COVID-19 immunization. Medical history included ongoing anxiety, from an unspecified date. The patient had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), acetaminophen (MANUFACTURER UNKNOWN), naproxen sodium (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. On 09Jan2021 at 01:30 AM, the patient experienced severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath, all of which were reported as being life-threatening. The patient went to the Emergency room due to the events. Therapeutic measures were taken as a result of the events and included: methylprednisolone sodium succinate (SOLUMEDROL) 125 mg, famotidine (MANUFACTURER UNKNOWN) 20 mg and diphenhydramine hydrochloride (BENADRYL) 50 mg. The clinical outcome of severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-01-13 lymph node pain, lymph node swelling right side between neck and clavicle appears to be swollen lymph node, tender to palpate, fatigue w... Read more
right side between neck and clavicle appears to be swollen lymph node, tender to palpate, fatigue will monitor and report to PCP if needed
41 2021-01-13 lymph node swelling, lymph node pain Large swollen gland on left side of neck. Sore gland.in left armpit area.
41 2021-01-13 lymph node swelling I had a swollen lymph node approximately the size of a baseball that developed under my left armpit;... Read more
I had a swollen lymph node approximately the size of a baseball that developed under my left armpit; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old non-pregnant female patient received the first dose on BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EJ1685), intramuscular in the left arm on 18Dec2020 10:00 AM (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included that the patient was diagnosed with COVID-19 prior to the vaccination. The patient did not have any allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient did not receive other medication in the two weeks prior to the vaccination. On 19Dec2020 14:00 PM, the patient experienced a swollen lymph node approximately the size of a baseball that developed under her left armpit. It took about 5 days to completely resolve. The patient did not receive any treatment for the event. The patient had not tested for COVID-19 post vaccination. The outcome of the event, swollen lymph node, was recovered, in Dec2020.
41 2021-01-13 lymph node swelling Severe axillary, supraclavicular, and ant cervical lymph node swelling on left. Left hand and facia... Read more
Severe axillary, supraclavicular, and ant cervical lymph node swelling on left. Left hand and facial numbness. Stroke w/u in ER with CT angio and perfusion and brain MRI with w/o gad all normal, labs normal. Sensory deficit resolved in 24hrs. Lymphadenopathy still severe at present.
41 2021-01-13 lymph node swelling My lymph nodes were very swollen on my right arm. I also developed headaches, fatigue and body aches... Read more
My lymph nodes were very swollen on my right arm. I also developed headaches, fatigue and body aches. Consulted with my PCP who suggested a mammogram and an ultrasound. Both done at Hospital. It shows lymph nodes are swollen and a follow up appointment has been schedule for 3 months. If they are still swollen a biopsy will be made.
41 2021-01-13 lymph node swelling sore arm on the same day , fatigue, next day woke up with swollen lymph nodes on my right arm same p... Read more
sore arm on the same day , fatigue, next day woke up with swollen lymph nodes on my right arm same place where injection was given , still sore and pain full to touch and headaches .
41 2021-01-13 lymph node swelling Extremely enlarged lymph nodes along axillary and clavicle. Elevated CBC counts. Appeared 8 days pos... Read more
Extremely enlarged lymph nodes along axillary and clavicle. Elevated CBC counts. Appeared 8 days post injection. Remaining enlarged still a week later. Fatigue as well.
41 2021-01-13 peripheral swelling Headache, Fatigue -30 min after (gone at 37 hours) Muscle Aches - 27 hrs after (gone at 37 hours) ... Read more
Headache, Fatigue -30 min after (gone at 37 hours) Muscle Aches - 27 hrs after (gone at 37 hours) Eyelid edema & swelling in fingers - 37 hours (gone 72 hours)
41 2021-01-14 anaphylactic reaction About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongu... Read more
About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongue and back of my throat. I waited to see if it would go away and then a couple minutes later noticed my lips started itching and swelling and from there it just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth throat & lips felt swollen and itching and she looked and said it was full blown anaphylaxis reaction. Administered EpiPen, benadryl and called ambulance where they took me to medial emergency department.
41 2021-01-14 lymph node pain, lymph node swelling Painful , very enlarged lymph nodes in right Axilla, Collarbone area, right side of neck and right b... Read more
Painful , very enlarged lymph nodes in right Axilla, Collarbone area, right side of neck and right breast. Extremely painful and swollen. Started approx 26 hours after injection - came on suddenly; Painful , very enlarged lymph nodes in right Axilla, Collarbone area, right side of neck and right breast. Extremely painful and swollen. Started approx 26 hours after injection - came on suddenly; This is a spontaneous report from a contactable nurse. A 41-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration (anatomical location: arm right) from 07Jan2021 14:00 to 07Jan2021 14:00 at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, pancreatitis, If-covid-prior-vaccination: Yes and allergies sulfa meds. Concomitant medication included paracetamol (TYLENOL) and metoprolol. The patient previously took codeine for allergies. The patient had first vaccine of BNT162B2 from 18Dec2020 to 18Dec2020 for COVID-19 immunization. On 08Jan2021 at 16:30, the patient had painful, very enlarged lymph nodes in right axilla, collarbone area, right side of neck and right breast. extremely painful and swollen. Started approx 26 hours after injection - came on suddenly. Outcome of the events was not recovered.
41 2021-01-14 lymph node pain Inject site pain; muscle/joint pain; muscle/joint pain; fever with temperature of 99-100.6 [units un... Read more
Inject site pain; muscle/joint pain; muscle/joint pain; fever with temperature of 99-100.6 [units unspecified]; under arm lymph node pain; headache; This is a spontaneous report from a contactable healthcare professional. A 41-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EL1284; expiration date: unknown), intramuscular left arm on 08Jan2021 08:45 AM at a single dose for covid-19 vaccination. Medical history included asthma, allergies, high blood pressure and gastric sleeve. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), beclometasone dipropionate (QVAR), mometasone furoate (FLONASE), aminobenzoic acid, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B-COMPLEX), cyanocobalamin (B-12), colecalciferol (D) and macrogol 3350 (MIRALAX). The patient previously took vancomycin but had allergies. The patient received the first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EK5730; expiration date: unknown) intramuscular left arm on 18Dec2020 07:45 AM at a single dose for covid-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received the most recent COVID-19 vaccine in a hospital. The patient experienced inject site pain, muscle/joint pain, fever with temperature of 99-100.6 [units unspecified], under arm lymph node pain and headache on 09Jan2021 23:30. The events were considered as non-serious. The treatment the patient received for the adverse event were acetaminophen (TYLENOL), fluids, ice packs and magnesium. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included temperature was 99-100.6 [units unspecified] on 09Jan2021. The outcome of the events was recovering.
41 2021-01-14 lymph node swelling, lymph node pain Swollen painful lymph nodes left armpit; Swollen painful lymph nodes left armpit; This is a spontane... Read more
Swollen painful lymph nodes left armpit; Swollen painful lymph nodes left armpit; This is a spontaneous report from a non-contactable nurse reporting for herself. A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 08:00 in left arm at single dose for COVID-19 immunization. Medical history included sulfa allergy from an unknown date and unknown if ongoing. Concomitant medication included buspirone hydrochloride (BUSPAR), lamotrigine (SUBVENITE) and quetiapine fumarate (SEROQUEL). The patient previously took amoxicillin and experienced allergies and received first dose of BNT162B2. The patient experienced swollen painful lymph nodes left armpit on an unspecified date. The outcome of the events was unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect. No follow-up attempts are possible. No further information is expected.
41 2021-01-14 lymph node swelling Swollen lymph node above collar bone on right side; This is a spontaneous report from a contactable ... Read more
Swollen lymph node above collar bone on right side; This is a spontaneous report from a contactable other hcp (patient). A 41-year-old female patient received the first dose of BNT162B2 (lot number: ER5730), via an unspecified route of administration on 30Dec2020 08:30 at single dose in the right arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included metformin. The patient experienced swollen lymph node above collar bone on right side on 07Jan2021. The patient did not receive any treatment for the event. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The vaccine was given in the Hospital. The outcome of the event was not recovered.
41 2021-01-14 swollen extremities, swelling Day of vaccine, patient started feeling fatigue, malaise, site pain & swelling, joint pain all over,... Read more
Day of vaccine, patient started feeling fatigue, malaise, site pain & swelling, joint pain all over, profuse sweating w/no fever, chills, all over inflammation & swelling, hives upper extremity, petechial rash, and the next day after the vaccine, the patient started experiencing swelling in R-axilla (lemon size). 3 days after vaccine all symptoms have resolved except swelling in right axilla.
41 2021-01-14 peripheral swelling *Rash ,whelps and swelling on bilateral arms from the shoulder area to hands. *Rash ,whelps and s... Read more
*Rash ,whelps and swelling on bilateral arms from the shoulder area to hands. *Rash ,whelps and swelling on bilateral legs from upper thighs down to feet *Severe Itching Received the vaccination on Wednesday, January 6, 2021. Symptoms started on Saturday, January 9, 2021 around 1pm. Symptoms intensified as the days went by. Went to Urgent Care on Monday, January 11, 2021.
41 2021-01-14 swelling Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I ... Read more
Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I had severe bruising, dark purple, the size of a half dollar, that JUST went away and I am due on 1/17/2021 for my next vaccine. I had no pain, only dark purple bruising and swelling. The headache and mouth issue went away after three days.
41 2021-01-17 lymph node pain, lymph node swelling, swelling face Started with aches, pain and headache on 1/14 pm. By 1/15 am temperature had spiked to 106 but was ... Read more
Started with aches, pain and headache on 1/14 pm. By 1/15 am temperature had spiked to 106 but was responsive to acetaminophen and remained high until 1/17 am. patient is continuing to experience aches and pain still 1/18. Face was swollen and red until 1-17 pm. Lymph nodes in neck, collar bone and armpit on right side were swollen and sore. About 3 inches below actual injection site an area 1x2 inches is red and hot to touch still on 1/18
41 2021-01-17 lymph node swelling, peripheral swelling Fever of 102-103 F. Nausea, Vomiting, weakness, cough and post nasal drip. Inflammation of lymph nod... Read more
Fever of 102-103 F. Nausea, Vomiting, weakness, cough and post nasal drip. Inflammation of lymph nodes left upper extremity , head and neck. Began to feel difficulty swelling due to inflamed lymph nodes Treatment: Intravenous fluids, anti-inflammatory medication, sought treatment at an urgent care center. Ultrasound of left arm, axillary and neck and chest area for enlarged lymph nodes. Outcome- all symptoms resolved by 1/14 except some fatigue
41 2021-01-17 swelling face Had sore arm quickly after Chills 24hours after 30 hours after woke up with serve left side jaw pain... Read more
Had sore arm quickly after Chills 24hours after 30 hours after woke up with serve left side jaw pain into cheekbone and facial swelling on left side of face. Sunday called my employee health who sent me to ER. Given steroids for 4 days for swelling and pain to left cheekbone and jaw area (especially at the joint) noted mild left side throat swelling on exam (internal)
41 2021-01-17 swelling face Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a ... Read more
Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a day Shot 2 a shaky, weak, increased heart rate and blood pressure, moderate swelling of face, tongue, throat, intermittent dizziness and Left eye blurriest, left facial decreased sensation and pain from mouth to ear, pain behind Left eye - symptoms wax and wane throughout the day
41 2021-01-18 bursitis severe left shoulder pain: seen by orthopedics. the injection was placed incorrectly leading to bur... Read more
severe left shoulder pain: seen by orthopedics. the injection was placed incorrectly leading to bursitis
41 2021-01-18 lymph node swelling Adnopathy Headache Intermittent fever O2 sat fluctuates between 84-92% Joint pain Fatigued
41 2021-01-18 swelling face Decided to get second vaccine 1/11/21 even though she was still getting hives from 1st dose. Develop... Read more
Decided to get second vaccine 1/11/21 even though she was still getting hives from 1st dose. Developed swelling on inner canthus L eye. Saw Dr. 1/14/21 and famotidine was ordered. This reduced hives. In 1/16/21 developed swelling of R inner canthus. Took Benadryl and famotidine hs on 1/17/21. Took famotidine 1/18/21 before work, but developed hives under arms and tongue began to swell that evening. Took another dose of famotidine. Tongue improved within 40 minutes but L side of face began to swell. Took Benadryl 50mg. Facial swelling improved but did not go away. Called Dr. this am and was ordered a Medrol dose pack. If this is not effective then she will be referred to Dr., allergist.
41 2021-01-19 lymph node swelling Patient reported tightness in throat and swollen glands after injection. Rapid response called. Re... Read more
Patient reported tightness in throat and swollen glands after injection. Rapid response called. Returned to work with a follow up check by rapid response.
41 2021-01-19 swelling face "Pfizer-Bio-Tech COVID-19 Vaccine EUA" Physician contacted staff in regards to an individual who rec... Read more
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Physician contacted staff in regards to an individual who received the Covid-19 Vaccine on 12/19/2020. The individual reported sand paper face rash and full swollen face that started 3 days after receiving the vaccine (1/1/2021). Individual reported that she had Botox and facial fillers on 12/15/2020. This event was an unwitnessed by the staff at County Health Department. The event was reported to Epidemiologist.
41 2021-01-20 guillain-barre syndrome Employee received first dose of Pfizer-BioNTech Covid-19 Vaccine on 12/28/20. Per Employee's manage... Read more
Employee received first dose of Pfizer-BioNTech Covid-19 Vaccine on 12/28/20. Per Employee's manager: Patient began experiencing symptoms of neuropathy and was admitted to the hospital as an inpatient on 1/18/21. Informed from neurologist that most likely Guillain-Barré syndrome resulted from vaccine and instructed to not receive 2nd dose of vaccine at this time.
41 2021-01-20 lymph node pain, lymph node swelling entire body joint pain; axillary lymph node pain; same enlarged supraclavical lymph node; This is a ... Read more
entire body joint pain; axillary lymph node pain; same enlarged supraclavical lymph node; This is a spontaneous report from a contactable healthcare professional. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 5730 and expiry date: unknown), intramuscular on 08Jan2021 11:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant. There were no concomitant medications. Patient received the 1st dose on 21Dec2020 13:30 on the left arm. After the initial dose enlarged supraclavical lymph node enlargement on same side as vaccine dose-24 hour later-lasted 17 days after 2nd dose, same enlarged supraclavical lymph node within 2 hours of administration on 08Jan2021, followed by axillary lymph node pain starting at 8 hours (19:30) after dose, then groin lymph node pain and entire body joint pain at 12 hours (23:30) after 2nd dose, then ILI like symptoms for 36 hours. No treatment was given for the events. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
41 2021-01-20 lymph node swelling, lymph node pain Swollen, tender lymph node to right armpit lasting all day Saturday. The swelling improved with hea... Read more
Swollen, tender lymph node to right armpit lasting all day Saturday. The swelling improved with heat application and was gone by Monday
41 2021-01-20 lymph node swelling Approximately 4 days after first vaccine I began to develop lymphadenopathy in my right arm. Sympto... Read more
Approximately 4 days after first vaccine I began to develop lymphadenopathy in my right arm. Symptoms are still ongoing 7 days after they began.
41 2021-01-20 lymph node swelling itching; palpitations; back ache; had an allergic reaction; full blown hives; rash on her face, ears... Read more
itching; palpitations; back ache; had an allergic reaction; full blown hives; rash on her face, ears, legs and arms; fever; tired; sore throat; swollen lymph nodes; chills; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EJ1685, expiry: Mar2021) intramuscularly on 19Dec2020 at a single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. On 20Dec2020, the patient experienced fever, tired, sore throat, swollen lymph nodes and chills. On 08Jan2021, the patient experienced rash on her face, ears, legs and arms. On 09Jan2021, the patient had an allergic reaction and had full blown hives. It was also reported that the patient experienced itching and back ache on an unspecified date. The patient also experienced palpitation on an unspecified date and she went to the emergency room in which she was prescribed with lorazepam (ATIVAN). The patient was also treated with naproxen (ALEVE) for fever and back ache, steroid (unspecified) for allergic reaction and hives, TRIAMCINOLONE cream for the rash and HYDROXYZINE for the itching. Outcome of the events fever, tired, sore throat, swollen lymph nodes and chills recovered on 21Dec2020 while for the events full blown hives, itching, had an allergic reaction, rash on her face, ears, legs and arms, palpitations and back ache was unknown.
41 2021-01-20 lymph node swelling Diffuse rash and left supraclavicular lymphadenopathy; Diffuse rash and left supraclavicular lymphad... Read more
Diffuse rash and left supraclavicular lymphadenopathy; Diffuse rash and left supraclavicular lymphadenopathy; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:EL0142) via an unspecified route of administration into the left arm on 09Jan2021 08:45 at a single dose for covid-19 immunisation. Medical history was reported as non. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:ES1685) via an unspecified route of administration into the left arm on 19Dec2020 08:45 at a single dose for covid-19 immunization. On 09Jan2021 20:00, it was reported that the patient experienced diffuse rash and left supraclavicular lymphadenopathy. It was also reported that the events reported was treated with loratadine (CLARITIN). Patient was not pregnant. Outcome of events was not recovered.
41 2021-01-20 swelling hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakne... Read more
hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakness; joint hurting; fever; chills; whole body aches; restless; joints and muscles were hurting; She saw really bad redness and it was increasing in size; It was swollen and warm to touch; It was swollen and warm to touch; she has had horrible feelings; inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); Cellulitis; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 09Jan2021 at 10:30 a.m. at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medication were not reported. The patient received first dose on 21Dec2020 (lot number: EJ1685) on left Arm. Patient received second dose of the Pfizer COVID19 Vaccine on 09Jan2021 at 10:30 a.m. and until 11 that night she had no symptoms. She started feeling weakness and joint hurting. After midnight she had fever, chills, and whole body aches. She was restless. All her joints and muscles were hurting. The chills were really bad. She was taking Motrin 200mg and she took three pills at the time, so she took high dose kind of. It didn't get better until Monday, 11Jan2021, at around 1:00PM. It was She stayed home. She has heard from so many people that the second dose gives this kind of symptoms. She was already prepared with the medication. She knew the symptoms would get better. She didn't just right away go to the doctor. For two days she was running all the symptoms. Patient commented also that the last two days she has had horrible feelings. She didn't pay attention to the arm. With any shot, pain is normal. She was getting better with the other symptoms, but was feeling more pain in her hands. She saw really bad redness and it was increasing in size. It was spreading. When moving her arm, it was radiating under the arm and to the side of her breast. Then she felt really bad and came to work. She showed it to her friend and it was spreading and hurting. It was swollen and warm to touch. She went to Urgent Care downstairs. On 12Jan2021 at 10:50AM she went to Urgent Care and was diagnosed with cellulitis in left upper arm. Antibiotics were prescribed as treatment. She informed took vitamins. At the time of the reporting event outcome was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162BB2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-01-21 bursitis Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer ... Read more
Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer vaccinedose #2 on left arm on 1/6/2021 at 11:15 am. The pain persisted and increased in intensity despite the use of topical and oral anti inflammatory medications. She was evaluated by an orthopedist on 1/18/2021 who performed various imaging studies and diagnosed the acute condition as left subacromial bursitis and tendinitis secondary to vaccine infiltration in the left shoulder bursa. The employee informed employee health director on 1/20/2021 and evaluated on same day. On physical exam, she had marked tenderness on the left arm at site of injection and moderate decrease range of motion of the left shoulder. She has been prescribed physical therapy sessions of left shoulder for eight weeks and is continued on daily analgesics. SARSCov-2 Ab IgG test done on 1/20/2021 is negative She will follow up with her orthopedist for further diagnostic tests and treatment.
41 2021-01-21 swelling face Tightening of throat, facial swelling, and ear pressure 15 minutes post injection. Treatment given-e... Read more
Tightening of throat, facial swelling, and ear pressure 15 minutes post injection. Treatment given-epi 3mg via epi pen. Outcome- called 911 and medics took over
41 2021-01-21 swelling face Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to hav... Read more
Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to have rash to chest and neck. Patient stated she felt "warm in her neck and inner thighs". Rash progressed to ears and face. Patient stated she was having "tingling in the mouth w/progression to her face and eyes. Patient taken to triage area for observation, VS Q 5 mins. Patient noted to have tachycardia PR 103 and elevated BP 178/100 on initial VS. Pulse rate decrease after 5 minutes to 95. BP remained elevated. Patient placed on gurney in recumbent position and water given. Patient given a mirror to view face and patient stated " my face is swollen slightly". Absent selling to lips or tongue. EPI pen 0.3mg/0.3ml auto injector administered at 1339.patient transported to site ED for further evaluation. O2 applied enroute to ED at 4L/min via NC when patient stated she felt a little lightheaded. Patient care transferred to ED and report given.
41 2021-01-23 lymph node swelling Initially felt some anterior cervical lymphadenopathy Difficult to sleep that night due to muscle ac... Read more
Initially felt some anterior cervical lymphadenopathy Difficult to sleep that night due to muscle aches, had to continuously stretch in bed, headache, some nasal congestion (resolved quickly), muscle aches continued in the morning but worsened around 11:30am on 1/24 and developed fever to 100.9. Muscle aches and fever lasted until taking Tylenol a few hours later.
41 2021-01-23 swelling face Chills, fever, swelling in face where facial filler had been - this is the worst and most continuous... Read more
Chills, fever, swelling in face where facial filler had been - this is the worst and most continuous adverse effect now three full days later
41 2021-01-24 guillain-barre syndrome On 1/15/21, I had numbness and tingling, pain and burning in extremities. Went to the ER, had MRI, ... Read more
On 1/15/21, I had numbness and tingling, pain and burning in extremities. Went to the ER, had MRI, had lumbar puncture, symptoms assessed, blood work and diagnosed with Guillian Barre.
41 2021-01-24 lymph node swelling enlarged supraclavical lymph node enlargement on same side as vaccine dose; This is a spontaneous re... Read more
enlarged supraclavical lymph node enlargement on same side as vaccine dose; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot 5730, expiration date unspecified), intramuscular on 21Dec2020 13:30 at single dose (left arm) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. On an unspecified date, after initial dose, the patient experienced enlarged supraclavical lymph node enlargement on same side as vaccine dose 24 hours later and lasted 17 days. There was no treatment for the event. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. The patient had no other vaccine in 4 weeks and no other medications in 2 weeks. Outcome of event was recovering.
41 2021-01-24 peripheral swelling following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose... Read more
following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose on 1/19/2021- swelling and pain at injection side, right axilla severe pain, flu like symptoms, nausea, headache. migrane developed on day 3, on day 4 hives and pruritus all over the body, swelling of hands and feet, on day 5 the symptoms worsened despite medicating with OTC benadryl 50mg every 6hrs. Contacted PCP and was prescribed prednisone 20mg daily with some improvement. day 6- today rash still present, pruritus present, weakness, dizziness, shaky. unable to work or drive.
41 2021-01-24 swelling This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immun... Read more
This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immunization, she appropriately stayed in the waiting area for the 30 minutes. She then got in car and 15 minutes after, she noticed that her tongue was feeling full/swollen and that was experiencing neck swelling. These symptoms persisted and resembled a prior allergic response to Tetracycline and Aleve. Wheezing and breathing difficulty ensued and EMS was activated. On arrival to the emergency department she was found to have wheezing with stridor. A dose of epinephrine was administered and she was monitored in the emergency department with an initial improvement in symptoms. Approximately one hour and 30 minutes after initial epinephrine administration patient reported that she was having continued difficulty swallowing and she was starting to feel a little worse. At this point a second dose of IM epinephrine was administered. The patient was subsequently admitted to inpatient medicine team for further monitoring.
41 2021-01-24 swelling At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency ki... Read more
At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency kit brought to scene. Client reports feeling pins and needles in the back of her head. She feels that her tongue and neck are swollen but as assessed, they were not swollen. She also reports feeling tingling in her tongue and neck. She was AAOx4, in no acute distress, no SOB noted. Skin and lip color normal, cap refill <3 seconds. Heart and lung sounds normal. Vitals: BP: 128/80, HR: 90, O2: 99% on RA, RR: 18. She did not report any pain. EMS was not called at this time. It was decided by RRT team that client can be monitored for an additional 30 minutes. RN stayed with client throughout 30-minute monitoring period. RN stated that during monitoring period, client was fine but kept reporting that she felt a lump in her throat. Husband talking with RN revealed that client is not diagnosed with anxiety but does have it. At the end of her 30-minute monitoring period at 1:40 pm, RRT was called again. RN already with client and client reported that she felt tingling everywhere again all over her body and felt like she could not breathe. Additionally, she had that feeling of being embarrassed with the sudden rush of heat throughout her body. Additional RN's arrived to scene at 1:41 pm. Upon assessment, she was not SOB but had rapid breathing associated with anxiousness and nervousness, which she reported. RN noticed client's hands and arms were shaking and client stated it was because she was nervous. Client speaking in full sentences. At this point, RRT RNs decided that client needs 911 assistance which was activated by Fire Chief on site. RNs also assessed that client's tongue was swollen again. Heart and lungs sounds were normal. Vitals at 1:49 pm: HR: 102, BP: 144/70, O2: 95%, RR: 21. At this point, on the basis of the symptoms she was experiencing, RN's decided to administer Benadryl 50 mg IM that was in the emergency kit. When the decision was made, client was asked if it was okay to administer Benadryl IM. She was explained the purpose of Benadryl, the side effects, and risks and benefits. Client consented to receiving Benadryl IM. Benadryl 50 mg IM administered to RA by RN at 13:51. By 13:53, her tongue was not swollen anymore. At 13:58, she was not SOB anymore, talking in full sentences, no acute distress, tingling stopped. By 13:59, the same symptoms of tingling throughout her body, feeling a sudden heat rush throughout her body started again. HR: 65, RR: 21, O2 95%. At 14:01, EMS arrives, truck number 341, vitals stable on their end. At 14:04, client decided to go to RUHS via ambulance. One of the paramedics stated that client's hands were "cold as ice". At 14:07, report was given to paramedics/ambulance and client was in the ambulance. Care assumed by ambulance/paramedics.
41 2021-01-25 lymph node swelling Swollen lymph node right armpit
41 2021-01-25 lymph node swelling aches; muscle pain; low grade fever; enlarged lymphnodes left supraclavicular region; This is a spon... Read more
aches; muscle pain; low grade fever; enlarged lymphnodes left supraclavicular region; This is a spontaneous report from a contactable other health care professional. A 41-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3246), intramuscular on 11Jan2021 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history was not reported. The patient has no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), fexofenadine hydrochloride (ALLEGRA). The patient had first dose of COVID-19 vaccine on 21Dec2020 intramuscular at right arm. On 12Jan2021, the patient experienced aches, muscle pain, low grade fever, and enlarged lymphnodes left supraclavicular region. The outcome of the events was recovering. The patient did not receive treatment for the events.
41 2021-01-25 lymph node swelling Pt developed swollen lymph nodes in neck and bilateral axilla, fever, body aches, and fever with Tma... Read more
Pt developed swollen lymph nodes in neck and bilateral axilla, fever, body aches, and fever with Tmax 100.4. Also states she had visual hallucinations, "wild" dreams, and seemed "incoherent" when talking with her husband. All symptoms have resolved but still has swollen lymph nodes in neck that wax and wane. Also c/o right side ear pain and right side sore throat x 2 days. Right side ear pain started on 1/24/21, 5 days after vaccine.
41 2021-01-25 peripheral swelling 20 min after injection left arm/hand swelling. Hand swelling/difficult to bend fingers. Waited 30 mi... Read more
20 min after injection left arm/hand swelling. Hand swelling/difficult to bend fingers. Waited 30 min, offered benedryl, went home and rested. Arm hand still swollen on 1/25/21 but not as severe
41 2021-01-25 swelling face About 45 minutes to an hour after the administration of the vaccine m, my cheeks became red, hot, an... Read more
About 45 minutes to an hour after the administration of the vaccine m, my cheeks became red, hot, and swollen. There were also hives. I took Benadryl which stopped the spreading but it did not go away. I had shortness of breath, and by about 6:00 it was hard to breath when lying down. I did an albuterol treatment with my nebulizer. It helped but it took much longer than usual. There were was about 30 minutes that I found my epipen and was going to the ED if it got worse. My breathing improved. The red changed to pink but was still swollen and tight 7 hours later. The second one of Benadryl helped get rid of most of the pinkness. When I woke up this morning, I had a little bit of a wheezy cough that I didn?t have yesterday. My daily Zyrtec and singular helped that a little. I have new hives along my jawline this morning that are very minor but they do itch. The redness and swelling was similar to reactions I?ve gotten when I drink a beer or have eaten soft shell crab, but typically Benadryl will clear that up and it doesn?t linger for so long. This was more aggressive. My side effects at this point are minor, but I have a call in to my allergist to see if I should be doing anything different and questions about the second dose.
41 2021-01-26 lymph node swelling, swelling face Facial and mouth tingle initially. Day later dizzy-room spinning with light exercise. More facial a... Read more
Facial and mouth tingle initially. Day later dizzy-room spinning with light exercise. More facial and tongue swelling. Followed by 1 week of swollen glands and tender jaw.
41 2021-01-26 lymph node swelling severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left... Read more
severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left facial numbness; tongue numbness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 11Jan2021 at 09:45 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration) on 21Dec2020 at 09:30 AM in left arm for COVID-19 immunization. Medical history reported as none. The patient has no allergies to medications, food, or other products. There were no concomitant medications. 48hrs post second dose, the patient woke up with severe left axillary, supraclavicular and anterior cervical lymphadenopathy on 13Jan2021 at 06:15 AM. She also woke up with left hand numbness which she initially attributed to the degree of axillary lymphadenopathy bug 2 hours after waking. The patient also experienced left facial and tongue numbness. She went to ER and was evaluated for stroke (all studies normal including labs, CT angio/perfusion and MRI brain) in Jan2021. Facial numbness resolved in about 12 hours, left hand sensory issue is lingering but improving. All lymphadenopathy is ongoing and quite significant. The events resulted in emergency room/department or urgent care. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient had not yet recovered from the events severe left axillary, supraclavicular and anterior cervical lymphadenopathy as well as tongue numbness; while recovering from the event left hand numbness/left facial numbness. The events were assessed as non-serious. Information on the lot/batch number has been requested.
41 2021-01-27 guillain-barre syndrome 5 days after 2nd covid vaccine, I started experiencing severe pain, with pins/needles sensation. St... Read more
5 days after 2nd covid vaccine, I started experiencing severe pain, with pins/needles sensation. Started in plantar aspect of both feet and traveled upwards to my hands, in a matter of hours. Extreme pain in lower back and extremities caused me to go to the ER. Following lumbar puncture and a series of diagnostic tests, I have started on IVIG for Acute Inflammatory Demyelinating Polyneuropathy. This is a subtype of Guillain Barre syndrome, believed to be precipitated by autoimmune response generated from the 2nd covid vaccine. I am now on day 4 of my hospitalization.
41 2021-01-27 lymph node swelling, lymph node pain Felt a little fatigue and little tired. It was lymphadenopathy - super clavicle area - above clavicl... Read more
Felt a little fatigue and little tired. It was lymphadenopathy - super clavicle area - above clavicle and neck (above collarbone area) - painful lymph node inflammation - and tender, marble size inflammation. Gradually subsided within four weeks. Today it is very small size now but almost back to normal. I had consulted with a physician because in this area it can be a cancer concern and he said to watch and wait.
41 2021-01-27 lymph node swelling, lymph node pain Pain and swollen Lymph node in right arm pit.
41 2021-01-27 lymph node swelling Throbbing lymphadenopathy on left side of body with chills
41 2021-01-28 lymph node swelling weird taste (bitter) in her mouth; Lymphadenopathy; significant myalgias; injection site soreness; T... Read more
weird taste (bitter) in her mouth; Lymphadenopathy; significant myalgias; injection site soreness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received the second dose of BNT162B2 via an unspecified route of administration on 11Jan2021 at a single dose as Covid vaccine. Medical history and concomitant medications were not reported. The patient previously had her first dose of BNT162B2 on an unspecified date as Covid vaccine. The patient experienced significant myalgias and injection site soreness, both on 11Jan2021; weird taste (bitter) in her mouth and lymphadenopathy, both on 13Jan2021. The patient received her second Covid vaccine on Monday and was having a weird taste in her mouth (weird taste as bitterness). She has significant myalgia that resolved and injection site pain (injection site pain as soreness) that was resolving. She looked it up and could not find anything. She wanted to know if this was something that they were getting a lot of. The outcome of the event significant myalgias was recovered with sequelae on 13Jan2021 while of the rest of events was recovering. Information on the lot/batch number has been requested.
41 2021-01-31 lymph node swelling Severe Lymphadenopathy Supraclavicular lymphnodes axilla lymph node pain 10/10 radiating to neck ... Read more
Severe Lymphadenopathy Supraclavicular lymphnodes axilla lymph node pain 10/10 radiating to neck and back
41 2021-02-01 lymph node swelling body aches, muscle aches and swollen axillary lymph node under right arm (golf ball to tennis ball s... Read more
body aches, muscle aches and swollen axillary lymph node under right arm (golf ball to tennis ball size)
41 2021-02-01 lymph node swelling Chills, body aches, fever, swollen supraclavical lymph nodes on L side
41 2021-02-02 lymph node swelling Approx 7 days post vaccine, I developed a small jelly bean sized lump near my left clavicle. Im not... Read more
Approx 7 days post vaccine, I developed a small jelly bean sized lump near my left clavicle. Im not sure when it appeared, but I noticed it on 1/20/22 in the evening due to pain in that location and on the front on my shoulder near injection site. My seatbelt was rubbing on it.
41 2021-02-02 swelling Large swelling (about the size of a half baseball) Large Red area Hot to the touch Pain
41 2021-02-03 anaphylactic reaction Anaphylactic reaction to COVID-19 booster (2nd shot) Refractive Asthma brought on due to anaphylaxi... Read more
Anaphylactic reaction to COVID-19 booster (2nd shot) Refractive Asthma brought on due to anaphylaxis
41 2021-02-03 guillain-barre syndrome currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous repo... Read more
currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous report from a contactable physician report for self. This 41-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Breast cancer (remission, 15 years ago), GERD, Hyperlipidemia. Concomitant medication not reported. Patient previously received second dose of Gardasil vaccine on 16Dec2020 at left arm and first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 08:15 AM at left arm. Five days after 2nd covid vaccine (on 25Jan202021 01:00 PM), patient started experiencing excruciating pain along the plantar aspects of both feet. This, with numbness and tingling ascended upwards (in a matter of hours) to lower back and arms. Patient went to local emergency room and was later transferred to (Institute name) for higher level of care. She was currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy. This is a GBS-like illness. Very debilitating, due to pain. No motor deficits yet. Hoping the IVIG stops the Demyelinating process in its tracks. The events resulted in hospitalization for 6 days. Patient received Nasal Swab covid test date on 25Jan2021 with result of "Negative". The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported event acute inflammatory demyelinating neuropathy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-02-03 lymph node swelling fever (highest 100.8), severe muscle pain, joint pain, jaundice (I have Gilbert's sydrome), axillary... Read more
fever (highest 100.8), severe muscle pain, joint pain, jaundice (I have Gilbert's sydrome), axillary and cervical lymphadenopathy on L side, headache, restless leg, nightmares
41 2021-02-04 swelling face Facial filler swelling in cheeks and lips; Facial filler swelling in cheeks and lips; fever; chills;... Read more
Facial filler swelling in cheeks and lips; Facial filler swelling in cheeks and lips; fever; chills; coughing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (also age at vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number Not available/provided to reporter at the time of report completion, dose number: 1), via an unspecified route of administration in left arm on 21Jan2021 09:30 at SINGLE DOSE for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included prior to vaccination the patient was diagnosed with covid-19 on unspecified date. However, since the vaccination the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products and no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient experienced Facial filler swelling in cheeks and lips, fever, chills and coughing on 21Jan2021 at 12:00 AM. No treatment was received for the events. The case was reported to be non-serious (not resulting to death, Caused/prolonged hospitalization, Congenital anomaly/birth defect, Disabling/Incapacitating or Life threatening). The outcome of the events was not recovered. Information on the lot/batch number has been requested.
41 2021-02-05 lymph node swelling Swollen lymph node in arm pit on the same side as injection site
41 2021-02-07 lymph node swelling, lymph node pain Lymp nodes swollen in the neck area, underarm & clavicle area very tender & painful
41 2021-02-07 swelling face patient reported swelling of left side of face and we administered Benadryl 25mg at 12:10pm then pat... Read more
patient reported swelling of left side of face and we administered Benadryl 25mg at 12:10pm then patients other side of face started swelling. She felt like her throat was closing so we administered 1 dose of EpiPen 0.3mg at 12:30pm and called 911. EMS arrived on site 15 minutes later and took patient to ER.
41 2021-02-08 lymph node inflammation Got second vaccine on Tuesday feb 2, by Wednesday evening I felt extremely tired and sore muscles. ... Read more
Got second vaccine on Tuesday feb 2, by Wednesday evening I felt extremely tired and sore muscles. By Thursday/Friday I noticed that it seemed as though the glands in my neck were swollen (slightly affecting my salivary glands especially on left side). My left armpit is very swollen and remains swollen to today. By Friday and into Saturday and currently I developed tinnitus in both ears. My ears feel stuffy, like I went up in an airplane and they need to pop. The tinnitus is really loud, especially at night and has triggered my anxiety. I?m so upset and scared I?ll have tinnitus for life now. I?m an avid bird watcher and I?ve also prided myself on excellent hearing, so I?m taking this hard. Very, VERY, scared.
41 2021-02-09 lymph node pain, lymph node swelling Fever, sore throat, swollen lymph nodes in throat, clavicle, armpits and breasts, fatigue, chest tig... Read more
Fever, sore throat, swollen lymph nodes in throat, clavicle, armpits and breasts, fatigue, chest tightness, some shortness of breath, rapid heart rate upon moving
41 2021-02-09 lymph node swelling The today (day 3) my lymph nodes, under arms, are swollen.; The next day (day 2) I experienced chill... Read more
The today (day 3) my lymph nodes, under arms, are swollen.; The next day (day 2) I experienced chills and body aches throughout the day; The next day (day 2) I experienced chills and body aches throughout the day; became suddenly tired in the afternoon; first dose was on 22Dec2020 while second dose on 22Jan2021; sore arm within a few hours of getting the shot; This is a spontaneous report from a non-contactable healthcare professional (patient). A 41-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Covid-19 vaccine; lot number: EL 3249; expiration date: unknown), intramuscular left arm on 22Jan2021 15:30 at a single dose for covid-19 immunization. Medical history included allergy to mango and passion fruit and covid prior vaccination. The patient's concomitant medications were not reported. The patient did not have other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as Covid-19 vaccine; lot number: EH 9899) at the age of 41-year-old intramuscular right arm on 22Dec2020 15:30 at a single dose for covid-19 immunization. The patient reported that on her second dose, she had sore arm within a few hours (22Jan2021) of getting the shot. The next day (day 2 [23Jan2021 11:45 AM]), she experienced chills and body aches throughout the day and became suddenly tired in the afternoon. The today [25Jan2021] (also reported as day 3 [24Jan2021]) her lymph nodes under her arms are swollen. As of now (Jan2021), she has no chills, body aches are not as bad, and her left arm isn't as sore, but her lymph nodes are still swollen. It was reported that the treatment was unknown. The patient has not been covid tested post vaccination. The outcome of the event shills was recovered in Jan2021, for the event swollen lymph nodes was not recovered, as for the events pain in arm and ache were recovering, while the outcome of the other events was unknown.
41 2021-02-09 swelling, lymph node swelling I noticed a small lump near my collar bone on Saturaday 2/6/21. I looked up the lymph nodes in that... Read more
I noticed a small lump near my collar bone on Saturaday 2/6/21. I looked up the lymph nodes in that area, and then called my practitioners office on Monday. I was transfered to an Epidemelogy Nurse Answering service and received a call back shortly after from a Covid Vaccine Hotline nurse. By Monday, another smaller bump came out right next to the first one. I told her that I had swollen lymph nodes near my collar bone. She asked how big, I can feel all around the larger one with the tip of 2 fingers. She told me that it is normal to get swollen lymph nodes after any vaccine and I shouldn't worry about it. She told me to watch it and if it got larger or didn't go away, to call my practitioner again. Currently they lympth nodes haven't changed, but I have my booster in a week an a half, so I thought I should report this reaction, as it seems to be on the rare side of common side effects from the Pfizer vaccine from what I have read.
41 2021-02-10 lymph node swelling Lymph node swelling in underarm and chest, size of grapefruit.
41 2021-02-10 lymph node swelling swelling of lymph nodes on same arm of injection site; This is a spontaneous report from a contactab... Read more
swelling of lymph nodes on same arm of injection site; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date: not reported), via an unspecified route of administration, on 20Jan2021 14:30, at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. Medical history and concomitant medications were none. Family Medical History Relevant to the adverse event: Patient's mother has bad allergies and knows she is contraindicated to this vaccine, but patient has never experienced any allergic reaction to anything. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date: not reported), via an unspecified route of administration, on 30Dec2020 1:30 pm, at a single dose on the left arm for COVID-19 immunization (age at vaccination: 41-year-old). The patient was administered her first dose the vaccine on 30Dec2020. She was administered her second dose of Pfizer COVID-19 Vaccine 20Jan2021, completing treatment. On 23Jan2021 08:00, three days after receiving the second dose of the vaccine she experienced swelling of lymph nodes on same arm of injection site. She reported onset of swollen lymph nodes in left arm 23Jan2021 which is ongoing. The swollen lymph nodes are present in the same arm that she was administered both first and second doses. She looked on the CDC website and did not know that this was a reported a side effect of the vaccine. She assumes it will go away. She called to clarify if she should tell her healthcare provider about this or if there are any recommendations regarding this event. She has taken some Motrin to help with the swelling. The event did not require a visit to the emergency room of physician's office. Therapeutic measures taken as a result of the adverse event included Motrin. Outcome of the event was not recovered. The patient assessed the event as non-serious. She does believe the event was potentially caused by the vaccine.
41 2021-02-10 swelling face Itchy mouth, swollen face, itchy scalp, itchy ears
41 2021-02-11 swelling Itchy, redness, swelling, for 10 days. fatigue, dizziness, presyncope ongoing 3 weeks later
41 2021-02-12 lymph node swelling Localized enlarge lymph nodes/hypertension
41 2021-02-14 anaphylactic reaction Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: ... Read more
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe
41 2021-02-15 swollen extremities Pain in Arm; Pain and swelling below right arm pit; Headache; Nausea
41 2021-02-16 peripheral swelling Noticed swelling in my left hand around Feb 6th, but by Feb 13th entire left arm was swollen and war... Read more
Noticed swelling in my left hand around Feb 6th, but by Feb 13th entire left arm was swollen and warm and observed blue/purple skin coloring on upper arm and lower arm was red. Went to ER on Feb 15th, and ultrasound revealed a blood clot near the junction of the subclavian vein and cephalic veins. Diagnosis was idiopathic subclavian deep vein thrombosis (DVT). Started on enoxaparin and warfarin on Feb 15th. Referred to hematology and coumadin clinic to monitor INR.
41 2021-02-18 anaphylactic reaction Anaphylaxis
41 2021-02-19 peripheral swelling Dose 1: About 5 minutes after injection slight dizziness and ear felt stopped up. Later that night c... Read more
Dose 1: About 5 minutes after injection slight dizziness and ear felt stopped up. Later that night chest was flushed. Flushing lasted about 2 hours Dose 2: Due to flushing with last infusion, nurse told me to wait there 30 minutes after infusion. About five minutes after starting getting a headache and left ear was stopped up. Was told to take Benedryl if rash(flushing) came back with this infusion and to report symptoms to CDC. Headache and nausea felt till next day. Felt sick and headache riding in car. At 0130 am on 2/18/21 was awoken by pain under right arm. Very mild swelling noted but very sore to put arm down and tender to touch. Underarm still sore as of today Feb 20, 2021. Second day joint pain in shoulders, elbows, fingers, and knees. Joint pain improved but still there as of Feb 20, 2021. Ibuprofen and Tylenol did not help headache or joint pain. Third day headache off and on with nausea once, right hip pain. Feb 20, 2021 Fourth day underarm and joint pain improving , nasal and ear congestion
41 2021-02-20 lymph node swelling Headache and body ache and tiredness started 8 hrs after. 48 hrs later swelling and severe pain in ... Read more
Headache and body ache and tiredness started 8 hrs after. 48 hrs later swelling and severe pain in armpit. Alternating Tylenol and ibuprofen and still feel pain.
41 2021-02-21 lymph node swelling Runny nose, Body aches, fatigue, joint pains (diffuse), lymph node swelling of neck and axillary reg... Read more
Runny nose, Body aches, fatigue, joint pains (diffuse), lymph node swelling of neck and axillary region on same side as vaccination given, muscle soreness and pain of chest wall on same side as vaccination given, felt hot and prickly all over but not measuring fever, nausea. Symptoms started late Friday night after vaccination and are ongoing still as of Monday after receiving.
41 2021-02-21 lymph node swelling Notice about 3 days after vaccine large painful lump in Left breast. By day 5 it was bigger and ver... Read more
Notice about 3 days after vaccine large painful lump in Left breast. By day 5 it was bigger and very painful. The lump took over a week to soften and go away. I am still tender with some swelling in the arm pit lymph notes.
41 2021-02-22 anaphylactic shock Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache.... Read more
Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache. Approximately 24-48 hours after I received the vaccine I started developing a red, hot, itchy raised rash on my ears and buttocks which became more prevalent and peaked around 80-90 hours later. Approximately 82 hours after I received the vaccine, I began to feeI nauseous, dizzy, and fatigued so I stood up to get ready for bed early. While brushing my teeth, I went pale white and felt like I was going to vomit. I put the toothbrush down and got on floor. My pulse felt like it had stopped. I tried to check my pulse and I could only detect one beat every other second. I called for my spouse and by the time he got to bathroom I was passed out. I came back to after about 30 seconds and was convulsing from chills. He put a blanket on me and grabbed my Apple Watch to try to get my pulse which read in the 50s (so I assume it was much lower when I passed out). My hands and feet were tingly and I stayed on the floor until my pulse got back up. I then had diarrhea. At this point in time the rash was most prevalent and was present mostly on my buttocks but also on my ears, scalp, pointer finger on right hand, thighs, and hips. I went to doctor the following morning an my vitals, blood sugar, EKG, urine screen were stable and indicated no issues. 106 hours later I still have the rash on all areas mentioned and am dizzy, nauseous, and fatigued.
41 2021-02-24 swelling face After the shot, I only had a slightly sore arm. Several hours later, after I had fallen asleep, I aw... Read more
After the shot, I only had a slightly sore arm. Several hours later, after I had fallen asleep, I awoke to sudden onset face swelling on my right side, severe and sudden sneezing and stuffiness, and a severe asthma attack. We called 911, and in the meantime I took 2 Benadryl and used my rescue inhaler. My breathing was assessed as diminished by the paramedics, and I was taken to the hospital. I was given oxygen and prednisone, and monitored. About 2 hours later I was released.
41 2021-02-25 lymph node swelling Palpitations, swollen lymph nodes under my left armpit and general malaise the day after the vaccine
41 2021-02-28 swelling face Immediate reaction, took over care, flushed and itchy progressed to facial swelling and difficult ... Read more
Immediate reaction, took over care, flushed and itchy progressed to facial swelling and difficult of breathing and was given EPI IM and Benadryl IV, transported Hospital.
41 2021-03-01 lymph node swelling, lymph node pain I began having pain in the lymph nodes in my right under arm, then started experiencing stiffness in... Read more
I began having pain in the lymph nodes in my right under arm, then started experiencing stiffness in my neck, and today noticed a swollen node above my collar bone on the right as well. It is painful to touch and is radiating pain in my throat, right ear, and neck around the node.
41 2021-03-01 swollen extremities The arm pit got swollen up and the whole left side of the body started aching really badly. Could n... Read more
The arm pit got swollen up and the whole left side of the body started aching really badly. Could not move around and got headache and nausia too. That is still continuing tiil date.
41 2021-03-01 swelling face Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vac... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.
41 2021-03-02 lymph node swelling, lymph node pain Shakes, chills, mild temperature (100), insomnia, nausea, exhausted, weak. Entire left side hurt, l... Read more
Shakes, chills, mild temperature (100), insomnia, nausea, exhausted, weak. Entire left side hurt, lymph node under arm - near breast on side of vaccination swollen for 4 days. Headache Onset of chills began at 1am. Around 5am I started shaking and nauseous and I had not been able to fall back to sleep. 5am 2/25 until I woke up for the day 2/26 at 6am, I had the nausea, chills, weak. Lymph node swollen stayed for 4 days. I felt very confused, like I couldn't hold a full thought. No reaction to 1st vaccine except a sore arm
41 2021-03-02 swelling face Filler swelling (face); This is a spontaneous report received from a contactable other healthcare pr... Read more
Filler swelling (face); This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El9265, expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 17:00, at single dose, for covid-19 immunization, at a public health department. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date: unknown) received at 41 years of age, via an unspecified route of administration on the right arm, on 08Jan2021 17:00, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 31Jan2021, the patient experienced filler swelling (face) (pending clarification). It was unknown if treatment was received for the event. The outcome of the event was not recovered. The reporter assessed the event as non-serious.
41 2021-03-05 lymph node swelling My left arm (site of injection on a Wednesday) began to ache within 4 hours of receiving the vaccine... Read more
My left arm (site of injection on a Wednesday) began to ache within 4 hours of receiving the vaccine. I took Tylenol to treat the pain and drank a lot of water. I woke up the next morning at 630am in extremely bad pain. My left lymph node under my arm was extremely swollen and tight, agony to touch. My entire left side from head to fingertips to toes ached at a level of 9 out of 10. My neck aches across both shoulders and my lower back aches across to my right side; the rest of my right side was unaffected. I took Tylenol every 6 hours which dimmed the pain to about a 6, but it would wear off 4.5 hours later, jumping back up to a 9. I eventually started taking Aleve later that evening to help at around 6 pm. I would become warm off and on, running a very low fever. I didn?t have any other symptoms other than the extreme pain, aches, and feeling drained. The next day (Friday) my pain had decreased to a 7.5-8, but my lymph node was still extremely painful and swollen. The pain continued to decrease the next day to a 5; Sunday was the last day of the left side body aches and lymph node swelling. However, the next morning (Monday) I woke to extreme lower back spasms/seizing. I went to the clinic at 1pm and was given a shot of Toridol and prescribed Voltaire?s and Flexiril. The doctor had me stay at home until Thursday, but the pain is only now starting to ease today, Saturday, March 6. I still have fleeting aches at the injection shot in my left arm.
41 2021-03-06 swelling face Patient was waiting in the parking lot when she notified the attendant that sensation of right faci... Read more
Patient was waiting in the parking lot when she notified the attendant that sensation of right facial fullness. No other respiratory distress, shortness of breath or any other s/s noted by RN assessment. Pt states she forgot to notify of allergy to shellfish Benadryl 25 mg given PO. Instructed to seek medical attention if she has further problems. Patient states that she is going to take another dose of Benadryl later today. States feels better. No further complications. VS Stable
41 2021-03-07 peripheral swelling, swelling face o Complaint The patient is a 41 year(s) old Female complaining of allergic reaction, nausea. o Chief... Read more
o Complaint The patient is a 41 year(s) old Female complaining of allergic reaction, nausea. o Chief Complaint Quote Patient complained of allergic reaction that started about 45 mins ago. She got her 1st dose of Pfizer Covid vaccine yesterday morning. She complained of rash all over the body, swelling on the hands and face including eyes and lips. She denied chest pain, abdominal pain, fever, cough, vomiting and difficulty breathing. She complained of nausea that started 5 mins ago. She has not taken any meds yet for her symptoms. o Time Seen 02-18-2021 01:20 o Historian patient ADDITIONAL HPI: o Additional HPI Pt here with concerns of allergic reaction. Pt fell asleep on the couch approx 2200. She awoke 2 hours later with itching of her hands. Over the next hour she developed a full body rash, itching, and swelling of face. No wheezing, no difficulty swallowing. Upon arrival to ED pt started to feel nauseated. Pt had first dose of COVID vaccine approx 16 hours prior to onset of sxs. No h/o allergic reactions, no h/o asthma. Emergency Department Course and Clinical Decision Making: Patient presents with urticaria and swelling to her face eyes and lips. Shortly upon being roomed she started to feel very nauseated and started vomiting. No stridor or wheezing, no immediate airway compromise but given both cutaneous and GI symptoms, significant concern for anaphylaxis. Patient was immediately given epinephrine intramuscularly, 0.3 mg. An IV was placed and she was given Solu-Medrol, Benadryl, Pepcid, and Zofran. Patient's urticaria and swelling started to nearly immediately improved after the epinephrine. She is feeling much better though slightly anxious. To be reaction from the Pfizer vaccine, no other obvious triggers, patient has no history of allergic reactions or other sensitivities. We will observe in the emergency department in a monitored setting for several hours to assure no rebound symptoms, patient updated on plan. 0500 Pt has been resting. Urticaria resolved, swelling to face resolved. Discussed with pt reporting reaction to CDC, info provided. Also discussed the second dose of vaccine, recommended reaching out to Epi response team or PCP to get recommendations. Will give short course of prednisone, 4 days, Benadryl as needed, ED return precautions discussed, will dc home.
41 2021-03-07 swelling Several bug bites that I had started to itch incredibly and swelled into welts. The injection site i... Read more
Several bug bites that I had started to itch incredibly and swelled into welts. The injection site itched too and was hard. My scalp psoriasis also itched a lot. All of this was Saturday, with night being the worst. The bug bites still itch but less than before. I believe this histamine reaction is related to six wasp stings I got in August 2020. I had a bad reaction to the stings. I have been using a prescription topical steroid ointment on the bites since Saturday, which I got for the wasp stings.
41 2021-03-08 lymph node swelling Swelling of the lymph nodes in the left arm and axillary area. Extreme fatigue. Fever of 101 on Marc... Read more
Swelling of the lymph nodes in the left arm and axillary area. Extreme fatigue. Fever of 101 on March 6 for approximately 12 hours. Bone pain. Severe headache.
41 2021-03-09 swelling face I was 32 minutes past receiving the vaccine when my face felt hot. I looked in the mirror and saw th... Read more
I was 32 minutes past receiving the vaccine when my face felt hot. I looked in the mirror and saw that it was. After about thirty more seconds I had trouble breathing and eventually could barely breathe. My face was puffy and my eyes started to close. I received IV Benadryl and two other medications which I can't remember.
41 2021-03-10 anaphylactic reaction ITCHING ALL OVER, SCRATCHY THROAT, ANAPHYLAXIS PT PREMEDICATED WITH BENADRYL 50MG PO AT HOME PRIOR T... Read more
ITCHING ALL OVER, SCRATCHY THROAT, ANAPHYLAXIS PT PREMEDICATED WITH BENADRYL 50MG PO AT HOME PRIOR TO COMMING FOR SECOND VACCINATION AT 1125 12:57 PT STATES S/S OF ANAPHYLACTIC REACTION, SCRATCHY THROAT, TONGUE SWELLING, HIVES, ITCHING VS TAKEN: HR 120,RR 20,BP 150/78, SPO2 100% RA 1258: EPI PEN GIVEN X 1 IM TO LEFT VASTUS LATERALIS, PT TOLERATED WELL. 1259: SQUAD AND ER NOTIFIED FOR NEED OF TRANSPORT TO CPH. 1301:DEXAMETHASONE10 MG IM IN RT LETOID GIVEN X 1, PT TOLERATED WELL. 1305: 20 GUAGE SL PLACED TO RT WRIST. PT TOLERATED WELL. 1315: REPEAT VS TAKEN AND STABLE HR 95, RR 20, BP 140/74, SPO2 100% RA. 1315 RESCUE ARRIVED AND TRANSFERED TO CPH
41 2021-03-11 anaphylactic reaction Anaphylaxis, swollen throat, itchy lips, hives.
41 2021-03-11 lymph node pain, lymph node swelling Swollen lymph nodes under armpit going into left breast, very painful and tender
41 2021-03-11 peripheral swelling Swelling and pain in left armpit on injected side (but can?t feel a lymph node), red rash and severe... Read more
Swelling and pain in left armpit on injected side (but can?t feel a lymph node), red rash and severe pain on injected arm, headache, muscle ache, joint pain, chills, stiff neck and shoulders with possibly inflamed lymph nodes.
41 2021-03-12 lymph node swelling FEVER, MUSCLE PAIN, TIREDNESS, HEADACHE, SWELLING OF GANGLIA UNDER ARM AND NECK, SENSATION ON THE HA... Read more
FEVER, MUSCLE PAIN, TIREDNESS, HEADACHE, SWELLING OF GANGLIA UNDER ARM AND NECK, SENSATION ON THE HANDS AND LIPS WITH LIKE PADDING AND TINGLING. PAIN IN THE INJECTION SITE.
41 2021-03-14 lymph node swelling, peripheral swelling In the arm where I received the shot and my body: Pain from shoulder to fingertip Swelling Tiredness... Read more
In the arm where I received the shot and my body: Pain from shoulder to fingertip Swelling Tiredness/fatigue Headache Muscle pain Chills Fever Nausea Armpit pain Lymph nodes swelling (size of an egg) discomfort with arm movements Itchiness Lack of appetite Pain in shoulder blade
41 2021-03-16 lymph node swelling 45 minutes after the vaccine I started with all over body itching, had not eaten, drank or taken any... Read more
45 minutes after the vaccine I started with all over body itching, had not eaten, drank or taken anything between the shot and time of the itching. I did about 20 minutes after the shot have a headache, severe arm pain, and then later that evening I had body aches, and the lymph node under my arm swelled up. I am still having the arm pain, swollen lymph node and itching and its 5 days later. I have been taking my already prescribed allergy medications as well as Benadryl and Claritin as advised by my doctor.
41 2021-03-16 swelling Swollen airway, head, and neck, intense itching and burning that lasted for 2-3 days
41 2021-03-17 axillary mass Lump in the armpit, discovered 5 days post vaccination
41 2021-03-20 lymph node swelling lymph nodes underneath the left armpit were swollen; This is a spontaneous report from a contactable... Read more
lymph nodes underneath the left armpit were swollen; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscularly, administered in the left arm on 12Feb2021 at 08:45 (Batch/Lot Number: EL9261) at 41-years-old as a single dose for COVID-19 immunisation; administered in a hospital. The patient's medical history was reported as none; no known allergies. The patient did not have COVID prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EJ1686, Administration time:08:45, intramuscularly, Left arm, Dose number:1) for COVID-19 immunisation on 22Jan2021 at 41-years-old. On 13Feb2021 at 07:00, after the second dose, the patient experienced: lymph nodes underneath the left armpit were swollen (non-serious). There was no treatment provided. The clinical outcome of the event, Swollen lymph nodes, was not recovered. The patient was not tested for COVID post vaccination.
41 2021-03-21 lymph node swelling, lymph node pain woke up Sunday morning [2 days after] with a swollen left arm pit ;same side as vaccine was given. A... Read more
woke up Sunday morning [2 days after] with a swollen left arm pit ;same side as vaccine was given. Area was tender, not discolored or warm to touch. Irritation the more I moved around. swelling was soft and pliable, no hardness. Monday morning swelling had decreased significantly. Email my care team on Sunday, Monday response was that swelling may have been attributed to the vaccine and I should file a report with CDC. No other symptoms other than soreness at injection site and body aches that lasted 24 hours.
41 2021-03-22 swelling face Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into nec... Read more
Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into neck. Heart rate went up to 122bpm. Left side of face felt puffy and numb. Left side of mouth and tongue were tingling. Reported this to vaccine giver, he had me wait about half an hour before suggesting Benadryl. Half an hour after 25mg Benadryl, symptoms were almost completely resolved. The next day (3/14) I felt tired. The day after (3/15) I felt hot and my skin was flushed. I was not running a fever. I generally felt unwell that day. I felt better by the time I woke up on 3/16. I also had a bad/metallic taste in my mouth through 3/21, which has resolved. My nurse practitioner suggested that I take Benadryl before I receive my second vaccine dose on 4/3/21.
41 2021-03-23 swelling Developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minut... Read more
Developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone Pepcid, and Allegra, after about 2 hours of observation in ED with gradual decrease in swelling of her lips. No shortness of breath at discharge.
41 2021-03-24 lymph node swelling 5 days after the shot, severe rash appeared all over upper body. Scalp, face, neck, ears, upper back... Read more
5 days after the shot, severe rash appeared all over upper body. Scalp, face, neck, ears, upper back and upper chest. Also one small patch on lower arm. Ears became swollen. Swelling of lymph node in neck on left side (same side as the shot). Took Benadryl for 4 days but rash and swelling remained unchanged. Went to doctor on 4th day after the rash started (9 days after the shot) and she prescribed Hydroxyzine for rash. Follow-up visit scheduled for 3/31/2021.
41 2021-03-25 lymph node pain, lymph node swelling Large swollen, tender lymph node in Right axilla 6 days after first shot 2/2/21 confirmed by ultras... Read more
Large swollen, tender lymph node in Right axilla 6 days after first shot 2/2/21 confirmed by ultrasound 2/9 second shot, in opposite arm, no adverse events, but right axilla lymph node still large and swollen
41 2021-03-25 lymph node swelling, lymph node pain Swollen, painful right neck lymph node 8 hours after injection. Heart palpitations/arrhythmia 3 day... Read more
Swollen, painful right neck lymph node 8 hours after injection. Heart palpitations/arrhythmia 3 days after injection. Ongoing as of 3/26/221
41 2021-03-25 lymph node swelling Started with horrible skull pain behind my left ear(Like a bad headache) . Swollen Lymph Nodes so s... Read more
Started with horrible skull pain behind my left ear(Like a bad headache) . Swollen Lymph Nodes so swollen it caused pressure on my ear and pain in outer ear. My NP could not confirm it was from the vaccine. They put me on an antibiotic and steroids and no relief .. then ear drops... I still cannot hear out of my ear completely and the Lymph nodes in neck, collar bone and armpits are still there and it's been 16 days since I had the shot.... I am refusing the second injection because of this. Nothing on right side of body only on left which is the injection side.
41 2021-03-25 lymph node swelling Painful swollen enlarged lymph node in left armpit
41 2021-03-26 lymph node pain, lymph node swelling Right lymph node in neck swelling/pain. Right ear pain
41 2021-03-26 lymph node swelling Shot received 3/25/21. 3/26/21: fatigue, headache, pain in left arm and neck 3/27/21: rash on left a... Read more
Shot received 3/25/21. 3/26/21: fatigue, headache, pain in left arm and neck 3/27/21: rash on left arm and left leg, swollen lymph in left armpit
41 2021-03-26 swelling face Pfizer COVID-19 Vaccine EUA 3/23: The patient presents with facial swelling and facial swelling. Pa... Read more
Pfizer COVID-19 Vaccine EUA 3/23: The patient presents with facial swelling and facial swelling. Patient a 41 y/o female with a history of HTN and anxiety presents to the Emergency Department with facial swelling in her left cheek that began today after she received her first dose of the Pfizer COVID-19 vaccine. She had a panic attack prior to getting vaccinated today. She was also feeling anxious while receiving the vaccine and states that she experienced a tingly sensation on the inside of her cheek as well as having a dry mouth. The patient denies trouble swallowing and eating, sinus pressure, shortness of breath, rashes, and dental issues. She notes that she has gone to the bathroom more frequently today but is not experiencing any diarrhea. Additionally, she has taken hydroxyzine for her symptoms. She is allergic to penicillin.. The onset was abrupt. The course/duration of symptoms is constant. Location: Left cheek. The character of symptoms is swelling. The degree at present is minimal. The exacerbating factor is none. The relieving factor is none. Risk factors consist of none. Prior episodes: none. Therapy today: prescription medications including hydroxizine. Associated symptoms: Dry mouth and tingly sensation on the inside of cheek. Associated injury none. She states she had a panic attack upon sitting down in the chair to receive her COVID shot in her left arm. She had to take her anxiety medication there and then later in the day. She states she felt as if the inside of her cheek was swollen and scratchy this made her very anxious and decided to come in to get checked out. She denies any hives any abdominal pain nausea vomiting shortness of breath chest pain or redness at the injection site. She feels mildly improved from an anxiety standpoint now compared to the onset but still mildly anxious. She has a very normal physical exam no neck tongue or lip swelling there is no redness at the injection site she has no hives abdomen is soft and tender or buccal mucosa is unremarkable ultimately patient reassured discussed it is important she get her 2nd COVID shot. She understands return precautions for signs of allergic reaction. She received no medications.
41 2021-03-28 peripheral swelling No immediate reaction ? 6 days later in the middle of the night I woke with diarrhea, extremely itch... Read more
No immediate reaction ? 6 days later in the middle of the night I woke with diarrhea, extremely itchy hands and feet (red and swollen), that was followed by an extremely quick onset of fever with sweating and dizziness. SEVERE stomach/gut cramps. I took two Tylenol, drank a bottle of water, used a heating bad on my back, a JOVI patch on my stomach and a cold wet towel on my neck and chest. After 40 minutes symptoms had curbed enough to sleep. Woke at 8:00am hands are still itchy and swollen, headache , fatigue and mild stomach cramps.
41 2021-03-29 lymph node pain, lymph node swelling I got fairly sick after the first dose with cold symptoms. They lasted about a week. The most severe... Read more
I got fairly sick after the first dose with cold symptoms. They lasted about a week. The most severe symptom was a sore throat that persisted the entire time. The second dose I didn't get any cold like symptoms, but my left arm was so sore, it sent pain along my back, neck and leg on the left side. The left underarm lymph node is severely swollen and hurts like hell. It's a little better the 3rd day after the 2nd shot, but it's still visibly swollen to look at and very tender to the touch.
41 2021-03-29 swelling Fatigued, swellling and soreness in armpits for over a week, headache for two days, depression and m... Read more
Fatigued, swellling and soreness in armpits for over a week, headache for two days, depression and moodiness, lack of appetite for several days after the shot
41 2021-03-29 swelling -yellow and green bruising -lump under the skin -warmth to touch -itchiness Treatment is ice packs ... Read more
-yellow and green bruising -lump under the skin -warmth to touch -itchiness Treatment is ice packs twice a day for 15 minutes at a time. Also, taking Ibprophen.
41 2021-03-30 lymph node swelling, lymph node pain Lymph nodes swollen in throat starting immediately after shot and continued until current date 3/31... Read more
Lymph nodes swollen in throat starting immediately after shot and continued until current date 3/31/2021. Sore arm at injection site for first 3 days. Lymph nodes behind right ear swollen and painful starting 3/30/2021.
41 2021-03-30 peripheral swelling Continuing a week after my vaccine- Painful armpit that felt like someone was scratching sandpaper o... Read more
Continuing a week after my vaccine- Painful armpit that felt like someone was scratching sandpaper on my armpit every time I moved, swelling of my left breast along with pain and sensitivity. After icing, I got it to go down but it was twice the size as normal, both of my hands and forearms being swollen every morning I wake up. The pain in my armpit has subsided but my breast is still very painful. Right after the vaccine for 3-5 days- chills, fever of 99.9-102.4, diarrhea, migraine headaches, lameness, and lethargic
41 2021-03-31 anaphylactic reaction Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sens... Read more
Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM. Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.
41 2021-03-31 lymph node swelling After receiving the 2nd dose of the Pfizer COVID vaccine, I was totally fine until about 16 hours la... Read more
After receiving the 2nd dose of the Pfizer COVID vaccine, I was totally fine until about 16 hours later. I woke up with a burning sensation in between my Shoulder blades, a fever, sweats, chills and body aches and severe joint pain. That started around 4:00am and was better around 1:00pm, but around 3:00pm noticed my lymph nodes felt swollen and my right arm pit was sore. Around 8:00pm, started to also feel achy again.
41 2021-04-01 neck mass Pt developed headache, followed by fever up to 102, then had skin hot to touch, developed reticular ... Read more
Pt developed headache, followed by fever up to 102, then had skin hot to touch, developed reticular rash extending up to neck/shoulder area on right, and a soft lump that is tender on right side of neck/supraclavicular region. Rash resolving as of 4/2/21 but lump and tenderness remain.
41 2021-04-01 peripheral swelling sore arm, followed by redness and hot to the touch and swelling in axilla 3 days post vaccination tr... Read more
sore arm, followed by redness and hot to the touch and swelling in axilla 3 days post vaccination treated with tylenol and ibuprofen, suggested warm compress as well
41 2021-04-01 swelling face 22 mins post vaccination at 10:50, pt c/o swelling on eyes, face and tongue. On site MD and ALS ambu... Read more
22 mins post vaccination at 10:50, pt c/o swelling on eyes, face and tongue. On site MD and ALS ambulance reported and assisted patient, BP 124/86, pulse 99, BS 108 and EKG normal; no meds given, transported to the nearest hospital by ambulance due to continued altered mental status possible stroke.
41 2021-04-02 swelling angioedema; Developed lip swelling; difficulty breathing; mouth numbness/tingling; mouth numbness/ti... Read more
angioedema; Developed lip swelling; difficulty breathing; mouth numbness/tingling; mouth numbness/tingling; dizziness; This is a spontaneous report from a contactable other health care professional. A 41-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 41-years-old, intramuscular, administered in Arm Right on 19Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included asthma. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the vaccine clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone, Pepcid, and Allegra, after about 2 hours of observation in ED with swelling decrease and no shortness of breath. The adverse event result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown the patient has been tested for COVID-19. Event outcome of lip swelling (angioedema) was recovering, of shortness of breath was recovered, of the remaining was unknown.; Sender's Comments: Based on temporal association and known safety profile of the product, there is a reasonable possibility that the events are related to BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-04-02 lymph node swelling Headache, 100+ fever, swollen lymph node, injection site redness and swelling, diarrhea, lethargic
41 2021-04-02 swelling Both inner thighs have been itching since about a week after first shot. 6 days after the second sh... Read more
Both inner thighs have been itching since about a week after first shot. 6 days after the second shot both inside thighs have softball size red, swollen patches that itcha and burn.
41 2021-04-03 anaphylactic shock Anaphylactic Shock; Allergic reaction; This is a spontaneous report from a contactable consumer (pat... Read more
Anaphylactic Shock; Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6203 and expiration date: Not available), via an unspecified route of administration in the right arm on 28Feb2021 at 12:00 PM as a single dose for COVID-19 immunisation. The patient was not pregnant. Medical history reported as None. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 28Feb2021 at 12:00 PM, the patient experienced Anaphylactic shock/allergic reaction. The patient received Epinephrine Injection for the events. The events resulted in a visit to emergency room/department or urgent care. The clinical outcome of events was recovered with sequel (with lasting effects). No follow-up attempts are possible. No further information is expected.
41 2021-04-03 peripheral swelling sore and swollen arm; sore and swollen arm; This is a spontaneous report from a non-contactable cons... Read more
sore and swollen arm; sore and swollen arm; This is a spontaneous report from a non-contactable consumer (patient). A 41-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number EL9261; expiration date not reported), via an unspecified route (administered on right arm) at the age of 41-years-old on 22Jan2021 06:15 AM as single dose for COVID-19 immunization. Medical history included seasonal allergy and penicillin allergy both from unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19 and didn't receive any other vaccines. The patient is not pregnant at the time of vaccination. The patient experienced sore and swollen arm on 23Jan2021. The events were reported as non-serious. Since the vaccination the patient has not been tested positive for COVID-19. No treatment was received for the events. The outcome of the events was not recovered/resolved. No follow-up attempts are possible. No further information is expected.
41 2021-04-04 anaphylactic reaction 45 minutes after injection of Pfizer (dose 1) patient felt dizzy. Was brought back to nurse that adm... Read more
45 minutes after injection of Pfizer (dose 1) patient felt dizzy. Was brought back to nurse that administered vaccine. Red splotchy chest, red ears, still dizzy and nauseous. Was admitted to ER where patient had 200/120BP and 140 pulse. Patient diagnosed with anaphylactic response to covid19 vaccine.. Epinephrine administered. Pepsid AC, Prednisone, and IV fluids. Vitals normalized and patient discharted ~2 hours later and prescribed pepsid, prednisone, and anti-nausea medication.
41 2021-04-04 oral herpes Aches, Chills, constant sleep, throwing up, headache, foggy head, cold sores
41 2021-04-05 swelling face, swelling 3-4 days after the first vaccine I had itchy neck and slight redness. Also, under the eyes I had sma... Read more
3-4 days after the first vaccine I had itchy neck and slight redness. Also, under the eyes I had small red patches that were mildly itchy. It went away after about a week. 4 days after the 2nd vaccine, in those same spots I experienced swelling, redness, itch. 6 days after the 2nd vaccine shot, my primary physician prescribed 3 doses of prednisone and Benadryl to alleviate the itch. Swelling and redness subsided but very mild itch was till there. On 04.05.21 (18 days after the 2nd shot) my face and neck swell up and are red and itchy. I also feel itchy ob my legs and beck. Benadryl did not help.
41 2021-04-05 swelling face during injection she had pain in left side of neck. about 1 hours after, she developed blurry vision... Read more
during injection she had pain in left side of neck. about 1 hours after, she developed blurry vision in left eye and numbness to left jaw and cheek area. took 50mg benadryl and used ice pack. in the morning she noticed swollen left side of face and continued numbness, tingling, which includes some near her eye. some flushed skin to area. Denies facial paralysis or weakness. Her eye no longer has blurry vision.
41 2021-04-05 swelling face Vaccine was administered in drive thru. I pulled out after and into one of the waiting spots. About ... Read more
Vaccine was administered in drive thru. I pulled out after and into one of the waiting spots. About 10 minutes after I was suddenly drenched in sweat and started to see black. My left side of body started to feel a burning sensation. I had been told to honk and put on flashers if anything went wrong. I did and waited more than 30 minutes. No one ever came to check me. After about 10 more minutes I started to feel better but was still pale and my face looked slightly puffy. I never saw anyone so I eventually drove home, drank a ton of water, ate some saltines and then slept a little. Had chills off and on that day and remained tired the next day. Felt fine by day 3
41 2021-04-05 swelling face I waited the 30 min for high risk and about 5 min after I left my face started burning like I had a ... Read more
I waited the 30 min for high risk and about 5 min after I left my face started burning like I had a bad sunburn, started tingling and felt numb. Took Benadryl before bed. Woke up face slightly swollen and a little tingly. By 8am my tongue started tingling. Took 2 Benadryl and scheduled an apt with my PCP. Apt at 1:30 with PCP. Redness across chest & on & off tingling in face, lips & tongue. Slight swelling noticed by the doctor steroid shot & told to continue Benadryl & add pepcid. Still slight face, lips & tounge tingling & swelling.
41 2021-04-06 swelling I started developing a psoriasis-like rash below my lip and spreading down to my chin. I first saw b... Read more
I started developing a psoriasis-like rash below my lip and spreading down to my chin. I first saw bumps 2 days after my vaccine on April 1. Thinking it was acne, I began treating it with salicylic acid. That did not help and the rash continue to grow and develop bumps like whiteheads. The spreading and discomfort of the rash prompted me to visit my local urgent care. The doctor was unable to say exactly what caused the rash. Then, I began reading about possible vaccine side effects and I saw a picture of a rash that looks just like the rash below my lip. In this article - the bottom picture looks like the rash I have.
41 2021-04-07 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Aller... Read more
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tachycardia-Mild
41 2021-04-07 lymph node pain, lymph node swelling Swollen Lymphnodes in Collarbone, sore, proceeded to get more swollen as days went by.
41 2021-04-08 swelling face Hives worsening over 2 week period causing lip and face swelling. Also had body ache, fever, and hea... Read more
Hives worsening over 2 week period causing lip and face swelling. Also had body ache, fever, and headache for 2 days. Prendison prescribed with Benadryl, follow up appointment in 2 days. If symptoms worsen or trouble breathing or swallowing go to emergency room.
41 2021-04-09 lymph node swelling pain and tenderness over the thyroid; left axillary adenopathy/lymphadenopathy; significant thyroidi... Read more
pain and tenderness over the thyroid; left axillary adenopathy/lymphadenopathy; significant thyroiditis; neck pain; fatigue; palpitations; This is a spontaneous report from a contactable physician and a pharmacist. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular, administered in arm left on 10Jan2021 13:00 as a single dose (at the age of 41-years-old) for covid-19 immunization. The vaccine was administered at the hospital. The patient had no known allergies and no other medical history (reported as none). The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), administered in arm left on 20Dec2020 1:00 PM (at the age of 41-years-old) for covid-19 immunization. On 14Jan2021, the patient developed left axillary adenopathy which then subsided and developed left cervical lymphadenopathy and significant thyroiditis. The patient also experienced neck pain, fatigue and palpitations on 14Jan2021. On 15Jan2021, she had severe pain and tenderness over the thyroid. The reported events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received prednisone, propranolol, Tylenol, antibiotics as treatment for the events. The patient underwent lab tests and procedures included SARS-CoV-2 test both via PCR and Nasal Swab: negative on Jan2021, 17Jan2021 and 24Jan2021. The outcome of lymphadenopathy, thyroiditis, pain and tenderness over the thyroid was recovering and unknown for the rest of the events.
41 2021-04-10 lymph node swelling Burning in arm immediately following injection; heaviness/?dead arm? for 36 hours; muscular pain on ... Read more
Burning in arm immediately following injection; heaviness/?dead arm? for 36 hours; muscular pain on left side from breast area into front and back chest I left. Swollen lymph nodes and pain around left breast and armpit area, into back shoulder blade, lasting more than 10 days.
41 2021-04-11 lymph node swelling, lymph node pain A lymph node on the base of my neck on the left side swelled painfully. The lymph node is tender to... Read more
A lymph node on the base of my neck on the left side swelled painfully. The lymph node is tender to the touch. It does not hurt when it is not touched, but when touched the pain level is about a 4. Today is day 2 of the painful swelling. I have never experienced swelling or pain in this particular lymph node before.
41 2021-04-11 peripheral swelling Severe swelling and pain/tenderness in left arm, armpit, wrist, left side of my neck, left shoulder,... Read more
Severe swelling and pain/tenderness in left arm, armpit, wrist, left side of my neck, left shoulder, left ribcage (front and back), left knee , left ankle. Fatigue. Swelling and fatigue have been decreasing over the past days but are still present.
41 2021-04-11 swelling Patient was in her 15 minute wait after vaccination, and complained of swelling, itching, tingling, ... Read more
Patient was in her 15 minute wait after vaccination, and complained of swelling, itching, tingling, difficulty in breathing, coughing and gagging while in our observation tent. Client was brought inside by wheelchair to our emergency area for further evaluation. Client was answering questions, pulse ox read 100%, pulse 106. Client had increased complains of tightness in throat, was coughing. 4:11 pm- 0.3 Epi pen given in right thigh. Lot # OFM534, exp: 9/20222. Call made to 911. Client then lost consciousness, eyeballs were fluttering underneath lids. Sternal rub- did rouse client, but then she became unconscious again. Daughter then reported a history of allergy to MRI dye, Pulse 110, 2 L O2 started. Client remained unresponsive, but was breathing normally. 415- call to Dr to assess whether Benadryl should be given or not- since client was unconscious. 415 shaking/chills began, and daughter reported history of non-epileptic seizures, but none since 2019. 416pm EMS arrived- IV started and seizure #2 witnessed by EMS. Seizure meds given per EMS- client transported to hospital.
41 2021-04-11 swelling Large knot on right arm-massage therapy, tylenol Knot still has fever in it and is hot, sore, swolle... Read more
Large knot on right arm-massage therapy, tylenol Knot still has fever in it and is hot, sore, swollen
41 2021-04-11 swelling Throbbing/severe pain in left big toe (which had been injured about 7 months prior) Pain resolved ... Read more
Throbbing/severe pain in left big toe (which had been injured about 7 months prior) Pain resolved next day after taking ibuprofen. Redness and swelling continued for about 1 week.
41 2021-04-12 herpes virus infection Heavy vaginal bleeding with heaving clots since the first does was administered. Vaginal bleeding co... Read more
Heavy vaginal bleeding with heaving clots since the first does was administered. Vaginal bleeding continues as of today, April 13,2021 at 2:36pm 2nd side effect was herpes outbreak on right eyelid, my primary care provider was notified.
41 2021-04-12 sepsis Patient came to EC for suspected sepsis, fatigue, fever, and generalized body aches, recent chemo 6 ... Read more
Patient came to EC for suspected sepsis, fatigue, fever, and generalized body aches, recent chemo 6 days ago (4/7) with associated fatigue chills, admitted to observation for febrile neutropenia
41 2021-04-12 swelling 8 days after first pfizer dose covid vaccine injected into left arm, I found a small, pea-sized lump... Read more
8 days after first pfizer dose covid vaccine injected into left arm, I found a small, pea-sized lump on my left collar bone. I have no history of illness or cancer and I will see my doctor who may order tests.
41 2021-04-13 lymph node pain, lymph node swelling My lymph nodes in neck became very painful at 7 am and got worse through the day. I had to leave wor... Read more
My lymph nodes in neck became very painful at 7 am and got worse through the day. I had to leave work bc pain was so severe. I had bad wheezing and a terrible cough. I now three days later still have swollen lymph nodes, low temp, and hot sweats.
41 2021-04-13 lymph node swelling, lymph node pain Pelvic pain, pressure, discomfort, frequent urge to urinate especially at night. Swollen, throbbing ... Read more
Pelvic pain, pressure, discomfort, frequent urge to urinate especially at night. Swollen, throbbing lymph node right armpit with shooting pains.
41 2021-04-13 lymph node swelling Scratcy throat, head cold feeling, mild fever, tiredness, swollen nymph nodes in neck
41 2021-04-13 lymph node swelling Fever, chills, nausea, itchy rash on stomach neck chest back, swelling of lymph node of left arm, ac... Read more
Fever, chills, nausea, itchy rash on stomach neck chest back, swelling of lymph node of left arm, aches. Took Tylenol and Benadryl.
41 2021-04-13 lymph node swelling Pfizer-BioNTech COVID-19 Vaccine EUA. Shortly after injection, during the initial 15 minute waitin... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Shortly after injection, during the initial 15 minute waiting period until 5 or 6 hours later, there was a weird taste in my mouth and a tightness in the back of my throat, as though the glands were swollen and constricted my throat making it uncomfortable to swallow. There was no pain. Between a rating of 1 to 10, the discomfort level was about 5. I also felt weakness in my whole body and walking felt strange and lasted for the entire day. The injection site has mild soreness even 24 hours later.
41 2021-04-14 swelling face 10 minutes after pain in arm was shooting down to hand and to chest, 10 mins later stomach ache, 30 ... Read more
10 minutes after pain in arm was shooting down to hand and to chest, 10 mins later stomach ache, 30 mins after adminstration tongue, face and throat swelled up. Hand of injection arm went purple, cold and numb. Toes went purple and cold. Had to get taken in ambulance to er hospital due to blood pressure and lack of oxygen. When arrived at hospital broken out in hive,blood pressure went up to 175/104 and severe pain in kidneys, stomach, lower abdominal, legs, arms. Day 2 high blood pressure, fever, hives, stomach, kidney and lower abdominal pain. Painful to urinate and poop.
41 2021-04-14 swelling Within 2 hours after vaccination, developed pain behind her right ear. Felt as if there was fluid a... Read more
Within 2 hours after vaccination, developed pain behind her right ear. Felt as if there was fluid and affected her hearing. She took Tylenol at that time. Around 2 a.m. the following morning (4/15), she rolled over in bed and felt a sharp pain on the left side of her neck. She got up and looked in the mirror and saw that the area was swollen and continued to get larger as the morning went on. She didn't take any medication this a.m. Took her child to school and then came for evaluation.
41 2021-04-15 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe
41 2021-04-15 swelling face Developed arm soreness, headache, and right eye swelling with eczema a few hours after 2nd dose. Had... Read more
Developed arm soreness, headache, and right eye swelling with eczema a few hours after 2nd dose. Had whole body aches and chills throughout the night. Woke up with swollen, red, itchy face. Had fatigue and dizziness throughout next day. Side effect subsided within 24 hours. 6 days post 2nd shot, developed face swelling, redness and itch. Woke up the morning of 7 days post 2nd shot with extremely swollen eyes, cheeks and lips that were red and burned. Went to ER and received 3 IV drugs, including Benadryl, took 3d of oral prednisone and also a topical steroid prescribed by dermatologist. Swelling and redness subsided within 48hrs but flared again 14d post 2nd shot. This flare was mild compared to d7, is limited to mild swelling of lips, redness and itch of lips and eyelids and is being treated with topical steroids.
41 2021-04-16 lymph node swelling Armpit lymph node swelling
41 2021-04-16 lymph node swelling Severe whole body muscle aches limiting normal daily activities. Chills. Arm soreness in injection a... Read more
Severe whole body muscle aches limiting normal daily activities. Chills. Arm soreness in injection arm, swollen axillary lymph node in injection arm, swollen bump at injection site.
41 2021-04-16 lymph node swelling Swelling and bruised feeling in arm pit and collar bone. Joints and tender points inflamed. Worse ... Read more
Swelling and bruised feeling in arm pit and collar bone. Joints and tender points inflamed. Worse on the left side of the body. Can not raise left arm up as stiffness and pain in underarm is intense. Expected, but tenderness, swelling, and pain at injection site. Feels like body was ramped up into a flare up (agin worse on the left side - same as injection side). Headaches.
41 2021-04-16 lymph node swelling Swollen arm on injection side. Swollen lymph node on left side collarbone
41 2021-04-16 lymph node swelling Swollen lymph node in left side of throat. Formed swollen lump that lingered for two weeks. No pain,... Read more
Swollen lymph node in left side of throat. Formed swollen lump that lingered for two weeks. No pain, just concern and made doctors appointment for examination.
41 2021-04-16 swollen extremities Swollen under armpit
41 2021-04-17 swelling face, swelling delirious; wheezing; fever up to 102.7; shortness of breath; coughing; slurring; body and face were ... Read more
delirious; wheezing; fever up to 102.7; shortness of breath; coughing; slurring; body and face were swollen all over; body and face were swollen all over; new onset of widespread bodily pain; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the right arm on 10Mar2021 at 11:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included hypersensitivity to iodine contrast, anaphylactic reaction, hypermobile Ehlers-Danlos Syndrome, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) being evaluated for mast cell activation syndrome. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast, estrogens esterified/ methyltestosterone (ESTROGEN/METHYLTES), and other unspecified medication. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 10Mar2021 at 14:00 the patient experienced a fever up to 102.7, extreme shortness of breath on standing, coughing and wheezing, delirious and slurring, body and face were swollen all over. The patient called the doctor on call at her primary care physicians office and treated the symptoms with diphenhydramine (BENADRYL), paracetamol (TYLENOL) and mast cell stabilizers. The patient had a bad flare of ME/CFS symptoms, in Mar2021, for about 7 days. She also experienced a new onset of widespread bodily pain in Mar2021 which didn't go away until the second vaccination. The patient received the second dose of BNT162B2 (Lot: ER8730) in the left arm on 31Mar2021 and had a better experience. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of delirious, wheezing, fever up to 102.7, shortness of breath, coughing, slurring, body and face were swollen all over was resolved with sequel on Mar2021; pain was resolved on 31Mar2021; bad flare of ME/CFS symptoms for about 7 days was unknown.
41 2021-04-18 lymph node swelling Musle pain is gone after 2days, Nausea :3~4th day after vaccination swelled lymps and thyroid: getti... Read more
Musle pain is gone after 2days, Nausea :3~4th day after vaccination swelled lymps and thyroid: getting better slowly but still have swelled lymps Fever for first 6 days: 99.8F after 6th day fever 99.2F~99.5F and start to have dizzyness
41 2021-04-18 swollen extremities Saturday 4/17/21 began to feel tired achy had severe muscle and joint pain like when I had COVID, ch... Read more
Saturday 4/17/21 began to feel tired achy had severe muscle and joint pain like when I had COVID, chills/sweating, right armpit is swollen. Slept the entire day, nauseous.
41 2021-04-18 swelling face Patient reported at 1213 tingling/numbness in her lips, right side of face and throat with redness a... Read more
Patient reported at 1213 tingling/numbness in her lips, right side of face and throat with redness and mild facial swelling of the right cheek. Pt. stated feeling "a sense of doom." She felt warm to the touch. Denied chest pain or dyspnea. 911 called at 1213. FD station is steps away from our site, so we rang their doorbell and they responded and were on site at 1216 with their 3 BLS supporting the 3 RN's on site mananging the event. Vitals #1: @1214 BP 180/100, P 100, RR 24, O2sat 98%. Vitals #2: @1219 BP 180/120, P 85, RR 22, O2sat 98%. ambulance arrived at 1220. Pt. remains with same and not worsening symptoms. Vitals #3: @1225 BP 150/120, P 98, RR 22, temp 100.1F. Pt. left in ambulance at 1230.
41 2021-04-19 oral herpes Cold sores on bottom lip (mouth)
41 2021-04-20 lymph node swelling, swollen extremities 24 hours after shot, I noticed lymph swelling at my collarbone and in my armpit on the side of the i... Read more
24 hours after shot, I noticed lymph swelling at my collarbone and in my armpit on the side of the injection (left side)
41 2021-04-20 swelling, lymph node pain Headache; 24 hours later swollen lymph nodes and swelling on left side (injection side) of the body.... Read more
Headache; 24 hours later swollen lymph nodes and swelling on left side (injection side) of the body. This has not subsided as of 9am on 4/21/2021. Neck is swollen and sore, lymph nodes are extremely sore and sensitive from ear to below breast. Scheduled for an ultrasound next week.
41 2021-04-21 anaphylactic reaction 20 minutes after my second shot, I developed wheezing at the base of my throat. It did not escalate ... Read more
20 minutes after my second shot, I developed wheezing at the base of my throat. It did not escalate to full anaphylaxis but remained a steady wheezing feeling for a number of hours after. It dissipated be evening but returned 4 days later along with tingling in my lips that comes and goes. It continues on and off 2 weeks post vaccine. I do not have any other illnesses or reasons to think this other than a side effect from the vaccine. I do not have a history of asthma either.
41 2021-04-21 lymph node swelling supraclavicular, axillary and neck adenopathy. pt did get second dose as well and adenopathy worsene... Read more
supraclavicular, axillary and neck adenopathy. pt did get second dose as well and adenopathy worsened. it has been 6 weeks since first injection labs normal. CT significant adenopathy still present on her left side both injections were on left
41 2021-04-21 swollen extremities, swelling COVID-19 SCREEN: Have you had close contact with a laboratory-confirmed COVID-19 patient within 14 d... Read more
COVID-19 SCREEN: Have you had close contact with a laboratory-confirmed COVID-19 patient within 14 days no Traveling in the last 14 days no Fever? no Body aches? no Cough? no Shortness of Breath/difficulty breathing? no sorethroat? no Loss of taste/smell? no headache? no Nausea no Vomiting no Diarrhea no _______________________________ 41 year old female presents with swelling and soreness to right shoulder, arm, axilla, and breast since Friday evening (3 days ago). She received 2nd dose of Pfizer covid19 vaccine to the right arm on day previous on Thursday at 3:40pm. Friday evening also started with the whole right arm feeling heavy and numbness to the right 2nd finger, fever 101F, fatigue, chills, and brain fogginess. Fever stopped the next day. 3/26/21 was first covid19 vaccine dose also to right arm, did not get any similar symptoms. Taking 200mg ibuprofen every 6 hours, Tylenol 325mg every 4 hours for soreness. Denies SOB, or pain or redness or rash at the injection site or redness at injection site. Denies fever or chills at this time. Deneis nausea, vomitng or diarrhea.
41 2021-04-22 anaphylactic reaction Patient developed hives on their chest and bilateral arms and difficulty breathing with concerns for... Read more
Patient developed hives on their chest and bilateral arms and difficulty breathing with concerns for anaphylaxis. On examination in the ED, the patient was noted to have a urticarial rash, mild oropharyngeal swelling and erythema, inspiratory stridor. Patient was initiated on anaphylaxis therapy after RRT on arrival to resuscitation room, starting with 0.3 mg of IM epinephrine. Also provided 50 mg of Benadryl, 20 mg famotidine, 125 mg of Solu-Medrol. Lactated Ringer's infusion began, received 1L LR. Patient was discharged home after resolution of symptoms.
41 2021-04-23 lymph node swelling Chills, fever, headache, muscle ache, swollen lymph nodes (deep pain in left breast)
41 2021-04-24 lymph node pain Nipple pain, very tender to the touch. Made wearing a bra or fitted shirt very uncomfortable for abo... Read more
Nipple pain, very tender to the touch. Made wearing a bra or fitted shirt very uncomfortable for about 24hrs without tylenol/motrin. The next day, some tenderness remained with the onset of lymph node pain under my arms.
41 2021-04-24 lymph node swelling, lymph node pain Lymph nodes in left underarm became very swollen and painful. The pain lasted 4 days. Pain relievers... Read more
Lymph nodes in left underarm became very swollen and painful. The pain lasted 4 days. Pain relievers and warm compresses did very little to relieve the pain.
41 2021-04-24 lymph node swelling On the 19th I developed a swollen lymph node under left armpit, on the 23rd my HSV 2 was triggered a... Read more
On the 19th I developed a swollen lymph node under left armpit, on the 23rd my HSV 2 was triggered after not having an outbreak over a year.
41 2021-04-24 lymph node swelling Swollen supraclavicular lymph node on same side as injection; This is a spontaneous report received ... Read more
Swollen supraclavicular lymph node on same side as injection; This is a spontaneous report received from a contactable consumer. This 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration on 22Mar2021 at 17:45 (at the age of 41-years-old) as single dose in left arm for COVID-19 immunisation. The patient's medical history included POTS and Hashimoto's. The patient has known allergies. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Lot Number: EN6202) on 01Mar2021 at 05:45 PM in left arm. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced swollen supraclavicular lymph node on same side as injection. There was no treatment received for the event. The outcome of the event was not recovered. Follow up information requested.
41 2021-04-24 swelling an inch long lump near the collar bone that pains when pressed
41 2021-04-24 swelling Started 10 minute after the shot I was nauseous with a headache watery eyes , nose I had an asthma a... Read more
Started 10 minute after the shot I was nauseous with a headache watery eyes , nose I had an asthma attack, the nurse I seen took me to a curtain room and gave me 6 pumps of albuterol my bp was dropping at first and I was extremely weak and I took 2 more puffs and my BP went up now and the nurse wanted me to go to the ER and I got up and almost fell I was so dizzy I was given Benadryl at the hospital and received chest X-rays and was watched over and I was continuing to take Benadryl and albuterol around the clock, I was itchy all over and I?ve had to take my albuterol more often then usual now even though feeling better my heat rate is all over the place and and my period is extremely off as well clotting, tissue passing as the vaccine is now itchy again and swollen and hurting after 2 days as of your symptoms were gone
41 2021-04-25 lymph node pain Flu-like symptoms (fever, aches, fatigue, chills, sweats, lymph nodes in throat sore), plus arm pain... Read more
Flu-like symptoms (fever, aches, fatigue, chills, sweats, lymph nodes in throat sore), plus arm pain at site of vaccine. Second day began having acute chest and abdominal pain which primary care doctor wanted to see me for. Did EKG which was normal. Pain (including chest and abdominal pain) lasted several days, along with fatigue. 11 days later I still have intermittent pain down my arm all the way to hand on arm that got the shot.
41 2021-04-25 lymph node inflammation Joint pain, muscle aches, high fever, swollen lymph node in armpit. All went away within 48 hours ex... Read more
Joint pain, muscle aches, high fever, swollen lymph node in armpit. All went away within 48 hours except for joint pain in fingers and toes that I still have 2 weeks later
41 2021-04-25 lymph node inflammation Large swollen lymph nodes under left armpit
41 2021-04-26 lymph node swelling Swollen lymph nodes above left collarbone and in left side of neck, lethargy, headache, muscle pain.... Read more
Swollen lymph nodes above left collarbone and in left side of neck, lethargy, headache, muscle pain. Started with chills and general lack of energy within 6 hours of shot; lymph node swelling and deeper arm and shoulder pain presented 48 hours after shot and still persist at day 4.
41 2021-04-26 lymph node swelling Hard, swollen, moveable left supraclavicular lymph node
41 2021-04-27 anaphylactic reaction asthmatic reaction like hard time breathing; hard time walking; weak; No appetite; anapylactic react... Read more
asthmatic reaction like hard time breathing; hard time walking; weak; No appetite; anapylactic reaction; felt itching of her throat; fingertip started turning purple; coughing a lot; hard time breathing; hot feeling around her arms and left side of body; it has been three days since she has been really sick; she is easily tired.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm left on 21Mar2021 around 16:15 (Batch/Lot Number: ER2613) (at the age of 41-year-old) as single dose for covid-19 immunisation. Medical history included allergic to shellfish, ongoing systemic scleroderma, ongoing raynaud's syndrome (6 years ago) and interstitial lung disease (6 years ago). Concomitant medications included amlodipine besilate (NORVASC), at 5mg three times a day, prednisone (MANUFACTURER UNKNOWN) via oral at 5mg once a day; mycophenolate mofetil (CELLCEPT) at 1000 mg twice a day, hydroxychloroquine phosphate (PLAQUENIL) at 200mg twice a day, omeprazole (PROTONIX) at 40mg twice a day, sildenafil citrate (MANUFACTURER UNKNOWN) at 20mg three times a day, atorvastatin (LIPITOR) at 40mg once a day, gabapentin (MANUFACTURER UNKNOWN) at 300mg once a day; all are ongoing and taken for systemic scleroderma. The patient did not receive any other vaccines within four weeks prior to the vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect was none. On 21Mar2021, the patient experienced anaphylactic reaction and was rushed into to the emergency room after 25 minutes of receiving the vaccine. The patient stated she called the CDC they recommend not to take vaccine of the second dose. The patient stated now she just called and it has been three days since she has been really sick and they told her to call us because doctor at the emergency room at the hospital and specialist because she has an underlying disease (Scleroderma) and told her to double check if she does not take booster of Pfizer vaccine what is the effect in her body? patient stated they are giving her advice that if she does not take it can she can take the J&J. The patient explained after she was administered the vaccine, she went to the waiting area where they told her she should be held for 30 minutes then in about 15 minutes she started getting a hot feeling around her arms and left side of her body so she took off her sweater thinking that would make her comfortable because she was uncomfortable. The patient stated 25 minutes after sitting there the nurse asked if she was ok, so she went out for fresh air that day it was not hot in the hospital but the temperature was around 60 on Sunday so it was really nice weather and she went outside for a fresh breath of air for 5 minutes, stayed took off mask, and felt relieved. The patient went back inside of the room and felt itching of her throat, 25 minutes receiving the vaccine and it stopped when she received the epi pen. The patient stated she thinks she recovered from because since Sunday she has had different effects. Then coughing started 25 minutes so probably roughly around 4:45pm on 21Mar2021 and stated when they administered epi pen not sure time but probably after an hour was when she was reviving in the ER. The patient experienced fingertip started turning purple and this started 30 to 45 minutes when she was rushed to emergency room and because of everything going on she does not remember when it stopped. The patient stated the doctor gave her a shot of epi pen and hooked her up. They did a lot of things in the emergency room that she does not remember. She only remembers her whole hand was purple and they gave her the epi shot. The doctor asked does she know what he was holding, she responded an epi pen, and the doctor said yes. She confirmed she has never used an epi pen before since she has not had any other allergic life-threatening reaction from a vaccine. The doctor said he was going to administer it right now because she cannot breathe. At this time, she was conscious and had a hard time breathing, but was listening. The doctor administered the shot and the hard time breathing and coughing stopped like 30 seconds after. However, she is still having a hard time to breathe. The patient stated the purple hands probably wore off after an hour but since she has Raynaud's disease it was hard for her to recover from circulation of oxygen in body. The patient had hard time breathing because Tuesday she still felt like asthma attack so around Tuesday still having hard time of breathing and still coughing a lot. The patient stated on Wednesday (on 24Mar2021) coughing was regulated a little bit and every time she was walking, she would cough. The patient commented she was discharged from the hospital Sunday. Later confirmed she was not actually admitted, just in the emergency room. The patient stated after the anaphylaxis reaction she was discharged at 9:30 in the evening and the following day she emailed her specialists and then replied and gave her advice that they could give and that she needed to call CDC vaccine and then they check on her. The patient confirmed she did actually go to her physician's office. On 22Mar2021, the patient felt weak she was lying in her house the whole Monday and lying-in bed week and had no appetite. The patient had an asthmatic reaction on Tuesday (on 23Mar2021), like hard time breathing, and she called her pulmonologist, and it was not like emergency and she knows that because she has an underlying lung disease, so she used nebulizer every 6 hours and also used inhaler albuterol inhaler. The patient had hard time walking and stated on Monday and Tuesday she did not get up from bed only just to go to the bathroom and to clean herself but yesterday she started walking around the house and it was hard for her because she was still coughing but today, she was walking already. The patient stated yesterday she was ok but had a hard time if walking it was hard for her to get up from bed and she can walk but she is easily tired. The patient underwent lab tests and procedures which included CT exam as part of her diagnosis for medical condition on an unspecified date and results are unknown. The patient stated she did not have an exam in the emergency room. Therapeutic measures were taken as a result of events anaphylactic reaction, felt itching of her throat, coughing a lot, fingertip started turning purple, hard time breathing, asthmatic reaction like hard time breathing included Epi Pen, Benadryl, she had an IV and the medicine administered through IV was a steroid combination of Benadryl pepa something, and stated she did not know the spelling, but it was a steroid mix that she received in the emergency room. The patient stated when she was home, on Tuesday, she had taken a nebulizer albuterol every 6 hours. She mentioned she just took Tylenol one time Tuesday night because she felt she was getting a fever. Her temperature was 99, not yet fever, but temperature was 99. The outcome of the events asthmatic reaction like hard time breathing was recovered on 24Mar2021, it has been three days since she has been really sick and she is easily tired was unknown and all other events were recovering. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
41 2021-04-27 peripheral swelling, swelling it started about the 10 minutes after the shot.my lips started swelling up and my tongue started get... Read more
it started about the 10 minutes after the shot.my lips started swelling up and my tongue started getting tingly on the tip. my arm got swollen and was noticeable by the wrist area on the arm the shot was given on. my neck started to swell up on that side. then my cheak started getting numb like tingly feeling. it started coming up towards my face the numbness . they just gave shot of Benadryl. never had a reaction to a vaccine
41 2021-04-27 swelling face Left side of face swollen and numb. Under the care of a neurologist and attending physical therapy. ... Read more
Left side of face swollen and numb. Under the care of a neurologist and attending physical therapy. Diagnosed with Bells Parsey about 8 days after receiving first dose.
41 2021-04-27 swelling Besides a sore arm, my armpit area became swollen to the point I could not put my arm at my side wit... Read more
Besides a sore arm, my armpit area became swollen to the point I could not put my arm at my side without intense pain. My armpit swelled to the size of a softball or grapefruit. It lasted for several days. After about 3 days the swelling started to subside. It is now 3 weeks past and there is still minimal swelling.
41 2021-04-27 swelling She received the vaccine via drive through at the local fairgrounds. Notes she developed swelling ar... Read more
She received the vaccine via drive through at the local fairgrounds. Notes she developed swelling around her eyes within an hour. After 24 hours, she turned red, developed swelling on her entire body, and itchiness on her entire body. Notes her joints were painful; unable to make a fist with her hands. Also had a fever. No asthma symptoms. She called Urgent Care for advice, was recommended to take cetirizine or other antihistamines and pain medications. Patient took cetirizine and ibuprofen, symptoms resolved within a few hours. Still has some residual swelling around her eyes but notes it isn't itchy.
41 2021-04-28 swelling Pt reports acute swelling, mild pain, and episodic numbness and tingling into her 4th and 5th finger... Read more
Pt reports acute swelling, mild pain, and episodic numbness and tingling into her 4th and 5th fingers.
41 2021-04-28 swelling Sore arm then next day. Tuesday red hot arm with bump low fever of 99.7. Feeling tired. Thursday no... Read more
Sore arm then next day. Tuesday red hot arm with bump low fever of 99.7. Feeling tired. Thursday now still have fever off and on low grade. Arm is hot am like a sunburn and sore. Tired with headache.
41 2021-04-30 peripheral swelling My arm grew a large bump and now at hospital
41 2021-05-01 bursitis, swelling Subacromial bursitis and soft tissue swelling in upper bicep. Pain in shoulder at injection site rem... Read more
Subacromial bursitis and soft tissue swelling in upper bicep. Pain in shoulder at injection site remained until my visit to urgent care. My shoulder hurt at the injection site, then I began to experience pain when moving my arm at the shoulder. Back pain resolved 48 hours post vaccine but arm pain continued until May 23 thru May 25 when my arm pain progressed and I began to see visual redness and swelling in my upper bicep with warm and tenderness. Started on 10 days on prednisone which NP instructed me to start immediately.
41 2021-05-03 anaphylactic reaction About 15 mins after vaccine I felt a sudden onset of lightheadedness and feeling as if i would pass ... Read more
About 15 mins after vaccine I felt a sudden onset of lightheadedness and feeling as if i would pass out, told the nurse I was going to throw up. I was given zofran and Dr monitored Vs. I continued to experience waves of dizzyness, nausea, abdominal pain. Shaking followed (I felt so cold), along with frequent need to urinate and urgency to have a BM (loose) for several hours. I was given fluids and monitored. They gave Ativan 0.5mg 2.5 hrs later? I was discharged home at 8:45p.m. by Dr and told not to get the 2nd Vaccine. Symptoms continued and worsened on day 3 with Shortness of breath, chest pain and tingling in my arms that spread to my legs, back and neck. The first week I could barley walk and was seen in the ER 2 times for chest pain, shortness of breath, dizzyness, tingling, heart racing, diarrhea, nausea, muscle weakness, insomnia due to shortness of breath (gasping) with heart racing, & unable to control my body temperature. Given Prednisone 40mg which exasperated symptoms. 1/13/21 In ER and given Benadryl 3 bags of fluids, potassium and sodium. Postural tachycardia was noticed. Referral to Neurologist.High D-dimer at ER on 1/16/21 CT scan performed to rule out blood clot in lungs. Reffered to Cardiologist. Metoprolol and Colchicine was started in Jan by Cardiologist Dr . Weekly visits with Dr for the first couple months. More meds started to decrease inflammation. Furthur referrals to Immunologist, infectious disease, and Rheumotology. At 3 months worsening of tingling in my neck and headaches/burning that felt like shocks and shooting down neck and ears. Neurologist performed 3 view MRI to rule out transverse Myelitis. In ER early April for new onset of Petechiae, CBC labs normal. Immunologist states he felt i experienced an allergic reaction followed by secondary anaphalaxis. He is testing me for Mast cell activation syndrome (not diagnosed yet). Now almost 4 months later still unable to work. Waiting results to rule out POTS. Currently battle daily fatigue, chest pressure/pain, lung SOB, heavyness/pressure, with any exertion. I am limited with daily walking/normal activities. Symptoms that come and go are tingling, nausea, diarrhea, flushing of frequent urination, neck pain, regulating temperature.
41 2021-05-03 lymph node swelling, swelling Swollen with grape size lump (lymph node maybe) on right side of neck in between neck and shoulder, ... Read more
Swollen with grape size lump (lymph node maybe) on right side of neck in between neck and shoulder, feeling of swollen throat on right side. Neck ache. Didnt notice lump until about a week or week and a half after first covid dose. I am only thinking this is from the shot because I had NO previous problems until the shot,no reactions to any shots ever. I do receive a flu shot every year with no problems. I am pretty healthy besides high blood pressure.
41 2021-05-03 lymph node swelling Consistent swelling of the left clavicular lymph node, ongoing for 10 weeks
41 2021-05-03 swelling face Bell's Palsy; Mild tingling in the left arm; swelling on my left cheek; musculature changes in the l... Read more
Bell's Palsy; Mild tingling in the left arm; swelling on my left cheek; musculature changes in the left jaw, left cheek and facial nerve regions of left cheek (described as feeling similar to getting an injection at the dentist to numb your mouth).; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: 03461), via an unspecified route of administration in the left arm on 19Apr2021 at 15:45 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none and the patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included loratadine/pseudoephedrine sulfate (CLARITIN- D), fish oil, and a multi-vitamin (unspecified). On 19Apr2021, within 5 minutes of the vaccination, the patient experienced mild tingling in the left arm. On 19Apr2021, the patient experienced a feeling of musculature changes in the left jaw, left cheek, and facial nerve regions of left cheek (feeling similar to getting an injection at the dentist to numb your mouth). The patient was concerned it was Bell's Palsy however only noticed swelling on the left cheek. The symptoms remained the same for 2 hours without worsening, then subsided a little. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of Bell's Palsy, mild tingling in the left arm, "swelling on my left cheek", "musculature changes in the left jaw, left cheek and facial nerve regions of left cheek (described as feeling similar to getting an injection at the dentist to numb your mouth)" was resolving.
41 2021-05-05 peripheral swelling, lymph node swelling i have received my 2nd dose of pfizer and in the evening i experienced chills, fever arm left side p... Read more
i have received my 2nd dose of pfizer and in the evening i experienced chills, fever arm left side pain swelling and redness...following on the next day i woke up with subclavian lymph node swollen like a ball on my left side. I also experienced this on the 1 st shot. It was hard to deal with the effect of this i also have pain nerve pain and muscle ache all over my body. treatment included tylenol outcome is not recovered. day 2.
41 2021-05-06 lymph node swelling Clotting and breakthrough bleeding for 4 weeks following 1st vaccination, then swelling of lymph nod... Read more
Clotting and breakthrough bleeding for 4 weeks following 1st vaccination, then swelling of lymph nodes 48 hrs. following 2nd vaccination.
41 2021-05-06 lymph node swelling Site injection pain and swelling Fever spiked to 102.6 24 hours later Chills, severe body aches, he... Read more
Site injection pain and swelling Fever spiked to 102.6 24 hours later Chills, severe body aches, headache, swollen lymph node s have worsened
41 2021-05-06 lymph node swelling Extremely swollen lymph nodes in left armpit, pain in left fingers, low-grade fever
41 2021-05-07 swelling face urticaria; allergic process urticaria; swelling of the face; cough; shortness of breath; high blood ... Read more
urticaria; allergic process urticaria; swelling of the face; cough; shortness of breath; high blood pressure; dizziness; This is a spontaneous report from a contactable Other HCP, the patient. A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 09Apr2021 at 10:00 (Lot Number: Ew0150) as a single dose (at the age of 41-years-old) for COVID-19 immunisation. Medical history included allergy to animal from an unknown date and unknown if ongoing and COVID prior to the vaccination on an unknown date. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medication included anti contraception (unspecified product). On 12Apr2021 at 01:00 the patient experienced allergic process urticaria on the body and swelling of the face, cough, shortness of breath, high blood pressure and dizziness. The events all required visit to emergency department. The clinical course is as follows: on 12Apr2021 the patient started with a allergic process urticaria on the body and swelling of the face and this condition was getting worse with cough shortness of breath and high blood pressure and dizziness when on 14Apr2021, the patient couldn't stand it and went to the hospital. The patient was medicated with antiallergics and corticosteroids, but the patient still didn't feel well, her pressure keeps going up she still feel dizzy. Therapeutic measures taken as a result of urticaria, swelling, cough, shortness of breath, high blood pressure, and dizziness included unspecified antiallergics and corticosteroids. The patient was tested for COVID post vaccination on 14Apr2021 with molecular test (Swab sample) with negative result. The clinical outcome of the events allergic process urticaria on the body and swelling of the face, cough, shortness of breath, high blood pressure and dizziness was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of urticaria, allergic reaction, swelling, cough, shortness of breath, high blood pressure and dizziness. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-2021477200 mother/baby
41 2021-05-07 swelling left axillary swelling 12 days post vaccination for 3 days, no pain; injection site pain; This is a ... Read more
left axillary swelling 12 days post vaccination for 3 days, no pain; injection site pain; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246) at left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included Hypertension (HTN), Anxiety, Attention deficit hyperactivity disorder (ADHD). No Known allergies. Patient is not pregnant. Concomitant medication was not reported. First injection, 12Jan2021, injection site pain 1 day post vaccine (13Jan2021) and left axillary swelling 12 days post vaccination (24Jan2021) for 3 days, no pain. No covid prior vaccination. No covid tested post vaccination. Outcome of injection site pain was not recovered and outcome of left axillary swelling is unknown. Follow-up attempts are completed. No further information is expected.
41 2021-05-08 lymph node swelling Painful swollen lymph nodes under arm, same side where I got vaccinated.
41 2021-05-09 bursitis The woman administering my vaccine placed it really high into my shoulder instead of the deltiod mus... Read more
The woman administering my vaccine placed it really high into my shoulder instead of the deltiod muscle. Within 30 minutes of receiving the vaccine I had severe shoulder and arm pain, they next day 04/16/21 the pain was so bad that I could not use the arm/ shoulder at all. After 10 days I still had severe pain, minimum range of motion, could not dress myself, do my hair, lift my son etc. On 04/26/21 I saw my family Doctor, he told me these "wasn't much" he could do" and had no clue what SIRVA was. and told me to call the mass Vaccination Site. I spoke on 04/27/21 she spoke to their Dr. at , Dr said that based on where the shot was administered that it is likely what I am feeling is bursitis. That I should not get another covid vaccine and the one I received high in the shoulder ?should? be effective. Advised me to follow up again with Dr, my family Dr. Instead I went to see an Orthopedic Dr. on Thursday 05/06/21 at 9:45 am at . Dr agreed the shot was administered way to high based off of where the mark was still on my arm from the needle and my description of events, thought it was very likely that I have Bursitis based off of my symptoms. Made plans to schedule a steriod injection as soon as some other health issues clear up (diverticulitis)
41 2021-05-09 pancreatitis I was diagnosed with pancreatitis i started having stomach pain saturday afternoon. Monday I had ... Read more
I was diagnosed with pancreatitis i started having stomach pain saturday afternoon. Monday I had intense stomach pain that went into my back. went to care facility after work. they said they couldnt see me. They could get me in the next day. i was in soo much pain i said no i need to go to the ER. drove over to er and was seen there for 6 1/2 hours . given IV fluid and liquid ibuprofen
41 2021-05-10 peripheral swelling Severe chills, and high fever at least over a 103.0, but I'm not sure how high it went because I was... Read more
Severe chills, and high fever at least over a 103.0, but I'm not sure how high it went because I was to sick to check. This was followed by intense muscle cramping in my chest due to the high fever. I had migraines several times a week that have last lasted until the 2nd dose (today 5/10/2021). Left arm also swelled to almost double the normal size for about 3 days. Post shot fatigue lasted about a week. I checked with an allergist and they said this was a strong immune response because I had had Covid previously, and not an allergic reaction. They also said that my second dose reaction should be less strong.
41 2021-05-11 lymph node swelling swollen lymph nodes on side where second dose was given
41 2021-05-14 peripheral swelling Left calf pain started around 4/12; went to Total Access Urgent Care on 4/28 as pain had increased w... Read more
Left calf pain started around 4/12; went to Total Access Urgent Care on 4/28 as pain had increased with minor swelling and Ultrasound showed DVT.; swelling; Ultrasound showed DVT; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Apr2021 (Lot Number: er8733, at age of 41 years old) as single dose for COVID-19 immunisation. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included: Levonorgestrel; Pravastatin. The patient previously received Penicillin, dairy products. Left calf pain started around 12Apr2021; went to Total Access Urgent Care on 28Apr2021 as pain had increased with minor swelling and Ultrasound showed DVT (Deep vein thrombosis) in Apr2021. The adverse event result in Emergency room/department or urgent care. The patient received treatment for the adverse event: On Eliquis blood thinner for 3 months. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contribution of the suspect drug administration to the event deep vein thrombosis cannot be excluded, due to a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-05-14 swelling Three days (Thursday) after the 2nd vaccine a rash started around my waistline. Friday the rash spr... Read more
Three days (Thursday) after the 2nd vaccine a rash started around my waistline. Friday the rash spread a little more around my waist. Saturday it was also down my arms and top parts of my legs. Sunday it spread to my eyelids, neck, upper chest, and ears with swelling and intense itching and burning. Monday I saw the dermatologist who thought it was an airborne allergic reaction and prescribed creams and over the counter meds (pepcid and Zyrtec). Rash/ hives covered nearly my whole body on Monday, Tuesday, Wednesday, and Thursday with no change. Some welps, some hives,, nonstop itching... Friday it started to look and feel a little better and the dermatologist ordered stronger cream and prescription benedryl. Today is Saturday and the first day I really think it is healing and not as itchy.
41 2021-05-15 swelling On Friday night I noticed my arm was extremely sore. I woke up Saturday morning at 530 and the injec... Read more
On Friday night I noticed my arm was extremely sore. I woke up Saturday morning at 530 and the injection site was red and extremely swollen. Around 1130 am I noticed I had swelling and soreness in my left collarbone area. Sunday morning the swelling in my left collarbone area was worse. The injection site is still swollen and red and itching. I have emailed my primary care doctor with pics of the affected sites so see what if anything we should do.
41 2021-05-17 swelling face The bottom of the jaw is swollen and a hump has formed.
41 2021-05-18 lymph node swelling, lymph node pain painful, swollen lymph node in neck the very next day. Is still swollen 3 weeks later.
41 2021-05-18 lymph node swelling a lump came out close to my neck, lymph node type; This is a spontaneous report from a contactable c... Read more
a lump came out close to my neck, lymph node type; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EP6955, Expiration date was not reported), via an unspecified route of administration, in left arm on 09Mar2021 10:15 (age at the vaccination 41-years) as first dose single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included potassium citrate taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccine in four weeks. Patient received within 2 weeks of vaccination: Anticoncep, bifllex, wate way. It was reported that 10 days after first dose, a lump came out close to my neck, lymph node type on 19Mar2021 03:00 PM. Patient did not receive treatment for the event. The outcome of the event was unknown.
41 2021-05-18 swollen extremities Blood clot in neck; Shortness of breath (dyspnea); Pressure on her chest; Edema to her feet; Weight ... Read more
Blood clot in neck; Shortness of breath (dyspnea); Pressure on her chest; Edema to her feet; Weight gain of 2 pounds overnight; Rash on chest; Rash on chest, possibly due to tape (dermatitis contact); Heart palpitations; Oxygen saturations dropped to 85% on room air; Diarrhea; This is a solicited report based on information received by Pfizer. A contactable consumer reported that a 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization; treprostinil sodium (REMODULIN), intravenous from 03Mar2020 to an unspecified date at 0.041 ug/kg, then at 0.045 ug/kg with therapy dates unspecified, and then at 0.049 ug/kg with therapy dates unspecified, for primary pulmonary arterial hypertension; and macitentan (OPSUMIT) on 11Jan2021, orally from 11Jan2021 at 10 mg, 1x/day for primary pulmonary hypertension. Medical history included ongoing primary pulmonary arterial hypertension. Concomitant medication included sildenafil citrate. On 15Jan2021, the patient had a blood clot in neck. The patient was hospitalized from 15Jan2021 to 16Jan2021 due to the blood clot in neck. It was reported that on 15Jan2021, which is 10 months 13 days after initiating IV Remodulin, the patient was hospitalized due to blood clot in her neck. The patient went to the emergency room on 15Jan2021 and she was planned to be admitted to change her catheter, later she was hospitalized on the same day and her Remodulin central line was changed as per the prior plans of getting the catheter changed. The patient was discharged on 16Jan2021. The patient then had a rash to her chest (dermatitis contact previously reported) that started on 20Jan2021. The patient believed it was from the original dressing that was placed after her catheter was replaced. The rash to left chest around her Remodulin catheter line (dermatitis contact previously reported) was also reportedly itchy at night. On an unknown date in 2021, the patient's oxygen saturations dropped to 85% on room air (oxygen saturation decreased). The patient continued to have rash on her chest (dermatitis contact previously reported). On 29Jan2021, 10 months 27 days after initiating IV Remodulin, the patient was in the emergency room due to increased shortness of breath, pressure on her chest, edema in her feet and a weight gain of 2 pounds overnight. All the tests were negative but during walking test, the patient's oxygen saturation dropped to 85% on room air. The patient was advised to wear mask continuously. 2 weeks after receiving the first COVID-19 vaccine, the patient had heart palpitations, shortness of breath, and chest pressure 2 weeks after receiving the first COVID-19 vaccine (dyspnoea and chest discomfort previously reported). The patient went to the ER (emergency room), had worked up and was seen by a pulmonologist, nothing was found, and the patient was released home. The prescribing physician's practice ordered her to wear oxygen (O2) continuously. The patient said that she only wears it when she leaves the house and at night and was fine. She felt this episode was related to the COVID-19 vaccine and was not receiving the second dose. The patient stated that her physician had took her off the Opsumit due to shortness of breath (dyspnoea previously reported). The events 'blood clot in neck', 'shortness of breath (dyspnea)', 'pressure on her chest', 'edema to her feet', 'weight gain of two pounds overnight' and 'heart palpitations', resulted in emergency room visit. The event, 'diarrhea', was controlled with diphenoxylate and atropine (LOMOTIL). The patient had a walking distance test on an unspecified date in 2021 (results were not provided) and weight was 209 lbs on an unspecified date in 2021. The events, shortness of breath (dyspnea)', 'pressure on her chest' and 'heart palpitations', was reported as serious (medically significant). The events rash on chest, and rash on chest possibly due to tape (dermatitis contact) had not resolved while the outcome of the rest of the events was unknown. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up (12Mar2021): This is a follow-up solicited report based on the information received by Pfizer. Additional information included medical history, suspect drug data, reaction details and clinical course details. Information on the batch/lot number has been requested. Follow-up (04May2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the available information the events are most likely related to an intercurrent or underlying condition which is not related to the subject drug. There is a reasonable possibility that the drug contributed to occurrence of the event rash. The follow-up information received does not alter the previous company clinical evaluation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-05-18 swelling 1. Dizzyness (dose 2) 2. Low Fever (dose 2) 3. Muscle ache (dose 2) 4. Not able to lift left arm 5. ... Read more
1. Dizzyness (dose 2) 2. Low Fever (dose 2) 3. Muscle ache (dose 2) 4. Not able to lift left arm 5. Headache 6. Armpit swollen with minor pain 7. Tiredness
41 2021-05-19 axillary mass, lymph node swelling after 1st and 2nd doses of shot - my L armpit lymph nodes swelled and became tender and painful. Af... Read more
after 1st and 2nd doses of shot - my L armpit lymph nodes swelled and became tender and painful. After 1st dose the pain subsided after 3 or so days; wasn't too bad just uncomfortable. After the 2nd dose the lymph nodes swelled even more than the first time and there was a constant pain/discomfort that lasted for several days with no relief from tylenol and mild temp relief from hot compresses.
41 2021-05-19 swelling Within 10 minutes after getting injection - Hives/rash, swelling, increased heart rate and blood pre... Read more
Within 10 minutes after getting injection - Hives/rash, swelling, increased heart rate and blood pressure; Treated by ems on site with benadryl injection Took 1 benadryl tablet at home - 6pm same evening; Day 1 after - hot flashes/off and on fever with some redness of upper arms neck chest and face - approximately 10 times only lasting a few minutes each time; Day 2 after - muscle aches - all over weakness, odd pressure in back of head in the am lasted for about 20 minutes then moved to side of head and subsided after about 20 minutes Tightness in chest across whole front - felt like lungs were tight - never had trouble breathing or swallowing, but dr heard wheezing on occasion - prescribed albuterol. Redness and warmth/hot flashes a few times again. Went to clinic- explained all symptoms, had evaluation - all vitals/numbers good. Ride it out, side effects have been odd and are lasting longer than 24-48hrs. If not feeling any better by Monday call/get checked again; Day 4 after - slight tightness pressure in upper chest/lungs took 1 puff albuterol, returned after dose wore off. Feeling chills starting in the early afternoon then 1 hot flash. Feeling muscle aches more noticeable in upper legs after am dose of advil wore off; Friday - tiredness, muscle aches, pressure in lungs; Saturday - tiredness, muscle aches, pressure in lungs. Experienced menstrual cramps and spotting. I am on Depo Provera and have not had a cycle or cramps in a number of years. Sunday - pressure in lungs, aches, muscle aches, all morning to mid afternoon. Felt better mid afternoon to evening. At night, 2 hot flashes, pulse up a little; Next few days, continued muscle aches, tiredness, and occasional lung pressure. Overall symptoms lasted approximately 10 days. A month later I still have occasional pressure in my lungs.
41 2021-05-20 lymph node swelling headache with visual sensitivity, headache, hard to hear for a second, speech was impaired for a sec... Read more
headache with visual sensitivity, headache, hard to hear for a second, speech was impaired for a second, difficult to find words for a second, felts as if she had a fever and kept coming in flashes, pain went down leg, but then quickly went away, index knuckle on left hand felt burning, but went away,2nd day- tiredness, hot flashes, thirsty, 3rd day sleep disturbances, night sweats on each day since vaccine, throat dry on second day, 3rd day throaty dry, lymph nodes swelling, tired, this morning pain in right axillary area, neck still sore, dizziness this afternoon, abdominal upset this morning, hot flashes today
41 2021-05-20 lymph node swelling 2 DAYS POST 2ND DOSE, LYMPHADENOPATHY OF LEFT AXILLARY AND HEAVINESS IN LEFT MAMMORY TISSUE. 7 DAYS ... Read more
2 DAYS POST 2ND DOSE, LYMPHADENOPATHY OF LEFT AXILLARY AND HEAVINESS IN LEFT MAMMORY TISSUE. 7 DAYS POST 2ND DOSE, BEGAN EXPERIENCING PAIN IN THE PERI-AURICULAR AREA OF RIGHT EAR. DAY 8 LYMPHADENOPATHY OF RIGHT CERVICAL AND RIGHT MAXILLARY NODES
41 2021-05-21 lymph node pain Extreme fatigue, headache, slightly felt strangled on and off, body aches, lymph nodes hurt, body fe... Read more
Extreme fatigue, headache, slightly felt strangled on and off, body aches, lymph nodes hurt, body felt heavy, foggy brain(felt slightly drugged on and off ), injection site felt stabbed. Started 4 hours after shot on Thursday evening and lasted until Saturday morning. Also Smelled chlorine in my nose in the beginning.
41 2021-05-21 lymph node inflammation the patient reported Gland Inflammation By Breast on Left side of Body. The Vaccine was Given in Lef... Read more
the patient reported Gland Inflammation By Breast on Left side of Body. The Vaccine was Given in Left Deltoid.
41 2021-05-23 lymph node pain, lymph node swelling, swelling Morning after woke up with body aches, extremely sore neck, shoulder and back on the side of the inj... Read more
Morning after woke up with body aches, extremely sore neck, shoulder and back on the side of the injection and injection site. An overall unwell feeling. Tiredness. Night sweats and body chills. Also, swollen lymph glands and tenderness under my right arm pit about the size of half a tennis ball. It is now 05/24 and I don't have the unwell feeling, but still soreness in neck and shoulder and swollen, tender lymph glands under right arm pit.
41 2021-05-23 peripheral swelling Ankle ans lower leg swelling daily from 4/29- 5/20/21
41 2021-05-24 swelling face right side facial swelling, right side lip swelling
41 2021-05-24 swelling Swollen left Armpit and left neck.; Swollen left Armpit and left neck.; This is a spontaneous report... Read more
Swollen left Armpit and left neck.; Swollen left Armpit and left neck.; This is a spontaneous report from a contactable consumer or other non HCP. A 41-year-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL9262 and Expiration date was not provided), via an unspecified route of administration, administered in Arm Left on 23Jan2021 13:30 (age at vaccination 41-year-old) as 1ST DOSE, SINGLE for covid-19 immunization. Facility type for vaccination was hospital. The patient's medical history and concomitant medications were not reported. On 25Jan2021 08:00 the patient experienced swollen left armpit and left neck. Treatment was not received by the patient. The outcome of event was not recovered. Follow-up attempts are completed. No further information is expected.
41 2021-05-25 swelling, lymph node swelling, swelling face I developed a headache, dizziness, chills, and general unwell feeling a few hours after the shot. T... Read more
I developed a headache, dizziness, chills, and general unwell feeling a few hours after the shot. The headaches continue to occur everyday since the shot (5/14-5/26). Two days after the vaccine, I developed night sweats, which have occurred every night since then. Approximately a week after the vaccine, I woke up with swelling and pain in my shoulder and armpit area on the left side where I received the vaccine. The swelling and pain in the area has improved, but is not yet better as of today (5/26/2021). The swelling and pain moved into my neck area and is now in my face causing tightness and pain. I believe my lymph nodes are swollen due to the vaccine.
41 2021-05-28 swelling face throat felt like she had been talking all day and swollen; felt that they were giving a shot; couldn... Read more
throat felt like she had been talking all day and swollen; felt that they were giving a shot; couldn't get a full breath; right side of her face drooped a little; tongue was swelling; face, lips, eyelids and around them were swollen; intermittent chest pain; heart it felt achy at times; had a head rush; felt very hot suddenly; her ear started ringing and buzzing; she could not hear well; she felt immediately as if someone was trying to put her to sleep; She felt heaviness in her body, and in her chest and said it felt as if someone was lying on top of her.; her nose and mouth started to become gray and blue in color; numbness in her left arm; face, lips, eyelids and around them were swollen; face, lips, eyelids and around them were swollen; couldn't get a full breath because of the heaviness on her chest; fingers stay cold a lot; This is a spontaneous report received from a contactable consumer. This 41-year old female consumer (patient) received BNT162B2 dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 (Batch/Lot Number: ER8730) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included allergic to shellfish and almonds from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced a head rush after the first dose of the Pfizer-BioNTech Covid-19 Vaccine and felt that they were giving a shot . Everything was normal but when she came home, within an hour and 20 minutes, she suddenly felt very hot, her ear started ringing and buzzing, and she could not hear well. She said she felt as if someone was trying to put her to sleep. When the caller went to wash her face, she noticed her face, lips, eyelids and around them were swollen. The right side of her face drooped a little, it looked different on the jaw than the other side. The caller's tongue was swelling and her throat felt like she had been talking all day and swollen. She felt heaviness in her body like a weighted blanket and in her chest and said it felt as if someone was lying on top of her, it was like she couldn't get a full breath because of the heaviness on her chest. She also noticed that her nose and mouth started to become gray and blue in color but she could still swallow. She also had residual symptoms such as numbness in her left arm , it,feels like its asleep and intermittent chest pain like her heart it felt achy at times. This has gone away but it would come and go and feel like it was lightning, like thunder in her chest. Her fingers stay cold to the touch a lot from where they bend down to the tips more on her left than anything. She did not take herself to the emergency room or the doctor for the events. The caller didn't seek medical care because she had some medications at home that were for allergies from her allergist and it helped with the swelling. The patient reported the medicine was a powder tablet that is dissolvable, unknown name, she thinks she may have used it once, it has numbers on it. The swelling went down to where she felt like she was fine after taking them. The swelling in her face and her eye lids were puffy for a few days. The patient had blood work done the day of the vaccine, prior to receiving the vaccine and an electrocardiogram (EKG). Therapeutic measures were taken as a result of throat felt like she had been talking all day and swollen, tongue was swelling, face, lips, eyelids and around them were swollen, face, lips, eyelids and around them were swollen, face, lips, eyelids and around them were swollen. The outcome of right side of her face drooped a little was unknown, recovered from head rush, felt very hot suddenly, ears started ringing buzzing, couldn't hear well, trying to put her to sleep, face was pounding, face, lips, eyelids and around them were swollen, tongue was swelling, felt like something was heavy on her body, heaviness on her chest, blue and gray around her nose and mouth, chest was hurting, trying to put her to sleep, and felt that they were giving a shot on 06May2021, recovered on 09May2021 from face, lips, eyelids and around them were swollen, recovered on 10May2021 from chest was hurting and recovering from fingers stay cold a lot and numbness in her left arm. No follow-up attempts are needed. No further information is expected.
41 2021-05-30 lymph node swelling swollen lymph node in left armpit started 5/30/21 @ 1:30pm. Very sore to the touch
41 2021-05-31 lymph node swelling swelling of the left supraclavivular lymphnode; This is a spontaneous report from a non-contactable... Read more
swelling of the left supraclavivular lymphnode; This is a spontaneous report from a non-contactable other healthcare professional. A 41-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular first dose on 21Feb2021 10: 30 am at single dose (Lot Number not reported), and second dose on 14Mar2021 11:30 am (Lot Number: en6204) as single dose, both at site of left arm at the age of 41-year-old for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The patient experienced swelling of the left supraclavivular lymphnode on an unspecified date with outcome of unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
41 2021-05-31 lymph node swelling Lymph node swelling on day 7. Lasting to day 14; Back ache; fatigue; This is a spontaneous report fr... Read more
Lymph node swelling on day 7. Lasting to day 14; Back ache; fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 16Jan2021 12:45 (Batch/Lot number was not reported) as 1ST DOSE,SINGLE for covid-19 immunisation. The patient medical and concomitant medications were not reported. The patient had no known allergies. The patient had no other vaccine within 2 to 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination and since vaccination. The patient experienced lymph node swelling on day 7. lasting to day 14, back ache and fatigue on 23Jan2021. The patient did not received any treatment. The outcome of the events was recovering. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
41 2021-05-31 swelling The day after I received dose 2, 04/13/2021, I started having pain behind my eyes. I was feeling ver... Read more
The day after I received dose 2, 04/13/2021, I started having pain behind my eyes. I was feeling very fatigued. I had to take painkillers to help get through the day. I had a lasting headache for a whole week. My right armpit became swollen and sore. On 04/15/2021, I felt tingling on the left side of my body with mild dizziness and anxiety. I had a virtual visit with Dr. on 04/16/2021. I also had knee pain which is unusual for me. During my virtual visit, Dr. informed me that she felt fatigue for the week after she received her vaccine too. I was told that if my symptoms continue to follow up with the doctor. As of today, 06/01/2021, I can still see where I received the vaccination. I have a red bump there. It does not hurt, but it is noticeable.
41 2021-06-01 lymph node swelling Excruciating pain to right arm and severe right axillary lymphadenopathy; treatment is supportive, o... Read more
Excruciating pain to right arm and severe right axillary lymphadenopathy; treatment is supportive, outcome to be determined.
41 2021-06-01 peripheral swelling, swelling face She got her vaccine, she had no reactions at all. On 5/12/21, she woke up 2 days with ankle and fee... Read more
She got her vaccine, she had no reactions at all. On 5/12/21, she woke up 2 days with ankle and feet swelling, hand and face swelling, eyelid swelling. She had a fever up to 100.5. Her swelling has not gone down on any of the locations. She cannot even take her wedding bands off. Her feet are extremely cramped in her shoes. Her allergies have gone tremendously. She has been throwing up and have been nauseous a lot. She has not been taking anything but Benadryl for the reactions. She also has gained 7# since the vaccine. Her hands have also been shaky. She has not notified her doctor of any of these symptoms.
41 2021-06-01 swelling My lungs and my heart became full of pain and very swollen and lasted 2 days and nights. It felt wor... Read more
My lungs and my heart became full of pain and very swollen and lasted 2 days and nights. It felt worse when I sat up, coughed, raised my voice and walked up and down stairs. My heart felt like a filled up tight balloon and it hurt a lot. I looked it u and I think they describe this as mycarditus.
41 2021-06-03 lymph node pain, lymph node inflammation Body aches; painful lymph node sweeling underarm; painful lymph node sweeling underarm; uncontrolled... Read more
Body aches; painful lymph node sweeling underarm; painful lymph node sweeling underarm; uncontrolled shivers; nausea; tired; just overall felt unwell; This is a spontaneous report received from a contactable consumer (patient). A 41-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:45 (at the age of 41-years-old) (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. The patient medical history was reported as none. The patient had no known allergies. Concomitant medication(s) included cetirizine hydrochloride (ALLERTEC) taken for an unspecified indication, start and stop date were not reported; famotidine (PEPCID [FAMOTIDINE]) taken for an unspecified indication, start and stop date were not reported; spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265 and Expiration date was not reported) via an unspecified route of administration, in Arm left, on 12Feb2021 at 02:45PM, as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05MAR2021 at 03:30AM, the patient had experienced body aches, painful lymph node swelling underarm, uncontrolled shivers, nausea, tired, just overall felt unwell. The outcome of the events were recovering. The patient did not receive any treatment for the events. No follow up attempts are possible. No further information is expected
41 2021-06-03 peripheral swelling Painful rash on both legs; Painful rash on both legs; Colors range from red with variations of purpl... Read more
Painful rash on both legs; Painful rash on both legs; Colors range from red with variations of purple looking and feeling bruised with no injuries, sometimes brown also,; my legs and they are swollen; tingling sensations in my right and left hands; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant) received second dose of BNT162B2 (lot number: EN6203) on 19Mar2021 (41-year-old) on left arm at single dose for COVID-19 immunization. Medical history were none. Concomitant medications included bupropion hydrochloride (Wellbutrin), topiramate (TOPAMAX), phentermine, montelukast sodium (SINGULAIR). Historical vaccine included first dose of BNT162B2 (lot number: EN6202) on 26Feb2021 (41-year-old) at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered Hospital. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Patient had Painful rash on both legs that continues to change on 31Mar2021. It has been on knees down in different places. The spots on the back of her lower legs continue to hurt. Colors range from red with variations of purple looking and feeling bruised with no injuries, sometimes brown also, mornings it is painful to stand on my legs and they are swollen , also some tingling sensations in her right and left hands. The events were occurred on 31Mar2021. The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event: Steroid shot, prednisone, antibiotic. The outcome of the events was not recovered.
41 2021-06-05 lymph node swelling, lymph node swelling Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injectio... Read more
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Lymph Node Swelling-Severe
41 2021-06-07 lymph node swelling Gland in throat became very swollen, under left ear (side of vaccination in arm). Gland became so sw... Read more
Gland in throat became very swollen, under left ear (side of vaccination in arm). Gland became so swollen that my face went numb for 2 days on the left side.
41 2021-06-08 peripheral swelling Patient was given the first Pfizer COVID19 vaccine around 5:36pm. While waiting her 15 minutes patie... Read more
Patient was given the first Pfizer COVID19 vaccine around 5:36pm. While waiting her 15 minutes patient states that she is itchy, has blotchy skin, swelling in her feet and hands, and tingling in her face and lips. She is immediately brought back into theimmunization room for observation. Patient declined ice pack. After no signs of anaphylaxis and since patient was conscious and coherent, gave 25mg of diphenhydramine around 6:00pm. Told patient to remain seated for observation. Checked patient's bloodpressure at 6:12pm and it was 144/96 with pulse of 90. Patient states her blood pressure normally runs below 120/80. Brought patient back into immunization room for more monitoring. Patient states that symptoms are not improving. Recheck blood pressure at approximately 6:25pm and it was still elevated at 151/86 with pulse of 96. Patient declined ambulance ride and wanted to continue to be observed at the pharmacy. Continued to monitor patient and call pharmacy manager and market manager. Patient states that she has taken Benadryl and Zyrtec in the past for a previous allergic reaction and it did not lessen the symptoms. Discussed taking hydroxyzine and went over possible adverse reactions especially extreme drowsiness before giving to patient. Patient's husband was with her and would be driving her home. Gave hydroxyzine hcl 25mg approximately at 7:25pm and observed patient for additional 15 minutes. Patient felt comfortable enough to leave and go home with her husband. She stated that she has an epi pen and blood pressure monitor at her house and will continue to monitor symptoms and her blood pressure. Agreed if worsening symptoms to seek medical attention. Patient left pharmacy approximately at 7:40pm.
41 2021-06-10 peripheral swelling, swelling This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Arm Right on 13 May 2021 (at the age of 41-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history included ongoing blood pressure high and diabetes, asthma and vertigo from an unknown date and unknown if ongoing. Concomitant medication included amlodipine taken for blood pressure high from an unspecified start date and ongoing; metformin taken for diabetes from an unspecified start date and ongoing; atenolol taken for an unspecified indication, start and stop date were not reported; olmesartan taken for blood pressure, start and stop date were not reported; cinnarizine taken for vertigo, start and stop date were not reported; diazepam (VALIUM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine prior to Covid vaccine. Facility where the COVID-19 vaccine was administered was Hospital. Patient stated, first time she didn't take anything she just took TYLENOL but her arm swell up the same day on 13May2021 and she couldn't move my arm for 2 days, it was stiff she couldn't move my hand. she put some heating pad and ice pad like stuff on it and about on the third day it started to get better but then 2 days after that she woke up swollen and she couldn't move on an unspecified date in May 2021. This was freaking me out. Under my arm and all the way down she don't think it should swell up like that and it is on whole body on an unspecified date in May 2021. Patient stated, she took TYLENOL for relief joint discomfort and inflammation on an unspecified date in 2021. The patient underwent lab tests and procedures which included TSH test: unknown results on 22Apr2021. There was investigation assessment reported. Therapeutic measures were taken as a result swollen arm, mobility decreased, limbs stiffness, joint discomfort and inflammation. The outcome of events was unknown.
41 2021-06-10 swelling patient complained that she had a rash for 4 days. She also stated that she had pain on the top rig... Read more
patient complained that she had a rash for 4 days. She also stated that she had pain on the top right of her chest with some swelling. She went to urgent care and they are to be scheduling her for a CT scan. Finally urgent care stated that she was given blood pressure medication and she had no other history of hypertension.
41 2021-06-11 white blood cell count increased Acute Appendicitis
41 2021-06-14 lymph node swelling Developed a Mondor's cord in the left breast on the same side as the shot as well as swollen lymph n... Read more
Developed a Mondor's cord in the left breast on the same side as the shot as well as swollen lymph nodes in the left armpit. After palpation, doctor ordered a diagnostic mammogram and ultrasound to confirm the suspected thrombophlebitis diagnosis. Given topical NSAID for a month. Ultrasound repeated and cord and node swelling had resolved.
41 2021-06-14 swelling, white blood cell count increased Starting on the day after the vaccine 2nd dose, I got a very bad severe migraine like headache righ... Read more
Starting on the day after the vaccine 2nd dose, I got a very bad severe migraine like headache right away. I had extreme sensitivity to light and had to lay down. My left eye was getting blurry and I was feeling severe pressure and pain. I could not walk or stand up and felt very heavy. I had tinnitus (ringing in both ears) and painful inner ear pressure that exacerbated my headaches. The next day, my symptoms were getting worse and now I had pain in my neck and spine. My joints in my spine and neck felt swollen,inflamed and was very painful. I called my PCP and they recommended Tylenol and to go to Urgent Care. I was prescribed Prednisone and muscle relaxer. The medications did not help. My PCP then advised to go to the ER. They did blood work, 2 spinal taps, MRI and CAT scan. I was in the hospital for 1 night. Everything came back normal. I was discharge and instructed to let the vaccine run its course. I am still suffering with nausea, headaches, pain in neck and spine with no improvements. It has affected my quality of life and I am still out of work. I am unable to do simple daily tasks.
41 2021-06-15 lymph node swelling I got joint and muscle aches. Left armpit lymph nodes swollen for six days. Fatigue for three weeks ... Read more
I got joint and muscle aches. Left armpit lymph nodes swollen for six days. Fatigue for three weeks after vaccine.
41 2021-06-16 lymph node swelling "Pt is concerned about her persistent vaccine side effects. Pt states today is the fourth day S/P 2n... Read more
"Pt is concerned about her persistent vaccine side effects. Pt states today is the fourth day S/P 2nd dose of covid vaccine. States she still has low grade fever 99.0, chills and HA , feeling upset stomach (denies cramping states discomfort), nauseated and feeling of no appetite and states feels "" my lymph nodes are swollen."" 2nd dose on 05/10/21 at MTVW clinic. Scheduled appt with Urgent care on 05/14/21."
41 2021-06-16 lymph node swelling Swollen and tender lymph nodes under left armpit that appeared after the 2nd day and has continued s... Read more
Swollen and tender lymph nodes under left armpit that appeared after the 2nd day and has continued so far in to day 4; This is a spontaneous report received from a contactable consumer, the patient. A 41-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 10:45 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient did not have any allergies to food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications include LEXA PRO 10 mg and wellbutrin 300mg (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN) from an unknown date. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 22Feb2021 at 12:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine with four weeks prior to the COVID-19 vaccine. On 17Mar2021, the patient experienced swollen and tender lymph nodes under left armpit that appeared after the 2nd day and had continued so far in day 4. Patient did not receive any treatment for the swollen lymph nodes. The clinical outcome of swollen and tender lymph nodes was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
41 2021-06-16 swelling, peripheral swelling, swollen extremities My whole thighs is hurting; I couldn't move my arm for 2 days, it was stiff I couldn't move my hand;... Read more
My whole thighs is hurting; I couldn't move my arm for 2 days, it was stiff I couldn't move my hand; Joint discomfort and inflammation; Joint discomfort and inflammation; Even inhaling, exhaling is not comfortable; Whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely; Whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely; Whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely; Whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely; Whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0179), via an unspecified route of administration on 03Jun2021 (at the age of 41-year-old) at single dose for COVID-19 immunization. The patient medical history included blood pressure high, asthma, diabetes and vertigo. The patient concomitant medications included amlodipine besilate (AMLODIPIN (BESILAT) DEXCEL) taken for blood pressure high, metformin taken for diabetes, atenolol, olmesartan taken for blood pressure, cinnarizine taken for vertigo and diazepam (VALIUM). Patient did not receive any other vaccine prior to Covid vaccine. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0162), via an unspecified route of administration, administered at arm right on 13May2021 (at the age of 41-year-old) as single dose for COVID-19 immunization. The patient experienced my whole thighs is hurting, I couldn't move my arm for 2 days, it was stiff I couldn't move my hand, joint discomfort and inflammation on an unspecified date. On 04Jun2021, the patient had whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely, even inhaling, exhaling is not comfortable. Patient stated, I think I am having some kind of reaction with the shot (COVID-19 vaccine) because my whole entire body from my knee up to my neck is swollen. My whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely. Even inhaling, exhaling is not comfortable. Patient further stated, the next day the middle of the day almost every day my right arm started swelling up and next day my neck started swelling up. My whole thighs was hurting and was swollen. When I take vaccine I dont take any other medication, so I am not sure what is actually causing any problems. I havent taken anything else other than Tylenol. So, first time I didnt take anything I just took Tylenol but my arm swell up the same day. I couldn't move my arm for 2 days, it was stiff I couldn't move my hand. I put some heating pad and ice pad like stuff on it and about on the third day it started to get better but then 2 days after that I woke up swollen and I couldnt move. This was freaking me out. Under my arm and all the way down I don't think it should swell up like that and it is on whole body. The patient underwent lab tests and procedures which included TSH was unknown on 22Apr2021. The patient received Tylenol as a treatment medication for relief joint discomfort and inflammation. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
41 2021-06-17 bursitis Elbow bursitis. So painful I drove myself to the hospital. Prednisone mostly cleared it up in a few ... Read more
Elbow bursitis. So painful I drove myself to the hospital. Prednisone mostly cleared it up in a few days, but my elbow is still tender more than a month later. My activity and age do not make this a likely health issue for me.
41 2021-06-17 lymph node pain, axillary mass Lump in armpit area of left arm...arm which vaccine was recently given. Noticed over 24 hours after ... Read more
Lump in armpit area of left arm...arm which vaccine was recently given. Noticed over 24 hours after vaccination. Lump is tender to the touch and hurts when not touched. about the size of two golf ball; Lump in armpit area of left arm...arm which vaccine was recently given. Noticed over 24 hours after vaccination. Lump is tender to the touch and hurts when not touched. about the size of two golf ball; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0172; expiration date: not reported) via an unspecified route of administration in left arm on 08Jun2021 at 14:45 (at the age of 41-year-old) as 2nd dose, single dose for COVID-19 immunization. Medical history of the patient included allergy (unspecified) and mono about 7 months ago (unspecified). Other medications (concomitant) received by the patient in two weeks included birth control, venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication, loratadine (LORATADINE) taken for hypersensitivity, start and stop date were not reported for all medications.Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0172; expiration date: not reported) via an unspecified route of administration in right arm on 18May2021at 16:00 as first dose, single dose for COVID-19 immunization. On 09Jun2021, at 21:00, about 24 hours after, patient noticed lump in armpit area of left arm (arm in which vaccine was recently given). Lump was tender to the touch and hurts when not touched. It was about the size of two golf balls. No fever, no redness. Patient did not receive any treatment for the event. Outcome of the events were recovering.
41 2021-06-18 lymph node pain Starting in early June I developed pain in the lymph nodes of my neck. It is now the 19th of June, a... Read more
Starting in early June I developed pain in the lymph nodes of my neck. It is now the 19th of June, and the pain has not abated. No other signs of illness are present.
41 2021-06-18 lymph node swelling Swollen lymph nodes under left arm making left breast sore; Swollen lymph nodes under left arm makin... Read more
Swollen lymph nodes under left arm making left breast sore; Swollen lymph nodes under left arm making left breast sore; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route of administration in left arm on 02Mar2021 (Batch/Lot Number: EL3247), at 41 years of age, as single dose for COVID-19 immunization. Medical history was none. The patient didn't receive any concomitant medication and any other vaccine in the previous 4 weeks, she was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. On an unspecified date in Mar2021 the patient experienced swollen lymph nodes under left arm making left breast sore. The patient didn't receive any treatment for the events. At the time of the report the events had not resolved yet. No follow-up attempts are needed. No further information is expected.
41 2021-06-21 swelling face Large rash like spots appearing on rib cage Spread to stomach on 6/14 Now on 6/22 I have 3 more sp... Read more
Large rash like spots appearing on rib cage Spread to stomach on 6/14 Now on 6/22 I have 3 more spots including face with swelling
41 2021-06-24 lymph node swelling The next morning the patient woke up with a large ball under her axillae (likely enlarged lymph node... Read more
The next morning the patient woke up with a large ball under her axillae (likely enlarged lymph node) she states it was very large; she states it lasted 10 days and was very painful
41 2021-06-24 swelling, lymph node swelling Posterior auricular lymphadenopathy; Moderate to severe pain lasting; Severe lethargy; Left axillary... Read more
Posterior auricular lymphadenopathy; Moderate to severe pain lasting; Severe lethargy; Left axillary swelling without pain; Chills; Joint pain; This is a spontaneous report from a contactable nurse (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262) via an unspecified route of administration on 01Feb2021 at 12:45 (at the age of 41-year-old), as dose 2, single, in left arm for COVID-19 immunization at Urgent care center. The patient's medical history included hypertension, anxiety and attention deficit hyperactivity disorder (ADHD). Patient had no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246) via an unspecified route of administration on 12Jan2021 at 12:45 as single dose in left arm for COVID-19 immunization. On 01Feb2021 at 19:00, 6 hours 15 minutes after the second dose of vaccine, the patient experienced left axillary swelling without pain, and 8 hours after the second dose, the patient experienced chills and joint pain for 1-2 hours. 20 hours post injection, the patient had severe lethargy for 36 hours. On 06Feb2021 at 19:00, the patient experienced posterior auricular lymphadenopathy with moderate to severe pain lasting more than 24 hours and was ongoing. At this time adverse events was not medically attended, however, if ice and Motrin 800mg are ineffective, she would be seeking medical care on 08Feb2021. The patient had not received any treatment medications for the other resulted events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was not resolved. Follow-up attempts completed. No further information expected.
41 2021-06-25 lymph node swelling, peripheral swelling After the 1st shot, I had the usual sore arm and swelling. In the next few days, there was a large a... Read more
After the 1st shot, I had the usual sore arm and swelling. In the next few days, there was a large amount of swelling on the right side. Pain at the injection site, lymph swelling. It stayed pretty constant and I did my best to move my arm and use ice to combat the pain. For my second shot, I was still experiencing pain on the right side so I asked to have it in the left. I reacted with the typical low-grade fever and aches. I had some slight swelling on the left side but it went away in about 24 hours. Within that week the right side axillary area swelled up and pain got worse. My breast became very swollen too.
41 2021-06-25 swelling, peripheral swelling The patient described the following adverse reaction to her first Pfizer dose. Swelling of left arm ... Read more
The patient described the following adverse reaction to her first Pfizer dose. Swelling of left arm up to neck and down the lefts side of back with pain, throbbing, and numbness. She had severe back and arm pain for 3 weeks. Her gait and movement were impacted. She reported a headache that lasted four days that was focal behind her left eye. 8 weeks post-injection, she still has numbness and some aching pain in her back and neck. She sought care at a doctor's office.
41 2021-06-26 swelling Itching started on toes second day, lasted for 5 days. Ankles and lower legs started itching on the ... Read more
Itching started on toes second day, lasted for 5 days. Ankles and lower legs started itching on the third day, when scratched, swelling was noted, then hives after the 4th day. Itching above the knee started on day 6. Hives were only seen after scratching affected area. Hands and forearms started itching day 9, hives again noticed only after scratching affected area. Lower legs stopped itching day 11. Upper arms, shoulders, scalp, and neck started itching, with hives showing up after scratching on day 10. Unable to observe hives on scalp. Headache on day 8, 10, 11, lasting less than an hour. No medication taken for headache, and no antihistamines taken for hives or itching. I thought it was allergies, but nothing has changed in my lifestyle, and I've never had symptoms like this before. I searched online for Covid 19 vaccination side effects, and found similar symptoms reported. I know it's not severe or life threatening yet, but I wanted there to be another corroborating report of these possible side effects.
41 2021-06-27 lymph node swelling, lymph node pain Swollen and tender lymph node (under left arm)
41 2021-06-28 lymph node pain, lymph node swelling The lymph nodes behind both of my ears became so swollen and painful to the touch that I couldn?t we... Read more
The lymph nodes behind both of my ears became so swollen and painful to the touch that I couldn?t wear my eyeglasses for a week. After that went away, my spleen became tender and sore for approximately three days. Since getting the vaccine, I have episodes of dizziness and feel lightheaded frequently (a couple times per day). My periods were almost non-existent prior to the vaccine and now they?re very heavy and last a week or longer.
41 2021-06-30 peripheral swelling, swelling Dizziness about 30 minutes after. Approximately 6 hours after the injection site turned red, very ... Read more
Dizziness about 30 minutes after. Approximately 6 hours after the injection site turned red, very swollen, very painful, difficult to lift and move arm and very sore to touch or apply pressure. Approximately 10 hours after the injection began having COVID symptoms with fever of 102.1, all over body aches, headache, nausea, very fatigued, dry mouth, itchy eyes and eye drainage, neck pain and tenderness on the left side and pain and swelling running up left arm into shoulders and neck. Also, my right arm was very sore and tender in the exact same spot as my left arm injection site. Pain in left jaw and teeth and right groin area. As of 26 hours later I have the same symptoms as listed above and my head feels very heavy like I can?t hold it up.
41 2021-07-01 peripheral swelling fever for 5 days after vaccination, then developed leg swelling and weight gain with profound protei... Read more
fever for 5 days after vaccination, then developed leg swelling and weight gain with profound proteinuria. Kidney biopsy revealed minimal change disease
41 2021-07-03 anaphylactic shock About an hour after I got vaccinated, I started to go into anaphylactic shock. My throat started to ... Read more
About an hour after I got vaccinated, I started to go into anaphylactic shock. My throat started to close and I was having adrenaline rushes, heart rate instability, and dizziness. I felt very shaky and weak. I was able to reverse it with Benadryl and other antihistamines. I did not need my Epipen. My symptoms subsided after about 4-5 hours. I did not eat anything after getting the shot, and I was not exposed to any other allergen that could have caused an anaphylactic reaction. I have not started any new medications that could have caused this either. I believe my reaction was related to the vaccine.
41 2021-07-08 lymph node swelling, lymph node pain Tenderness from swollen lymphnodes in arm pit area; Swollen lymph nodes in armpit area; This is a sp... Read more
Tenderness from swollen lymphnodes in arm pit area; Swollen lymph nodes in armpit area; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 22Mar2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included omeprazole (PRILOSEC) OTC as directed on box for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 01Mar2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient previously received sulfamethoxazole (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021, the patient experienced tenderness from swollen lymph nodes in armpit area. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events lymph node tenderness and axillary lymph nodes enlarged. The clinical outcomes of the events lymph node tenderness and axillary lymph nodes enlarged were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
41 2021-07-08 lymph node swelling High fever of 102.8; Chills; Aches; Swollen lymph nodes under arm ofshot; This is a spontaneous repo... Read more
High fever of 102.8; Chills; Aches; Swollen lymph nodes under arm ofshot; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 22Mar2021 at 09:00 as a single dose (at the age of 41-years-old) for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergy to penicillin. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 01Mar2021 at 09:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within two weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 22Mar2021 at 21:00, the patient had experienced, high fever of (102.8), chills, aches and had swollen lymph node under arm of shot. Th patient did not receive treatment for the reported events. The clinical outcome of the events high fever of 102.8, chills, aches and swollen lymph node under arm of shot was resolved on an unspecified date in Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
41 2021-07-13 swelling, swelling face On May 16, 2021 I began to develop red, swollen bumps on my bilateral lower legs just below my knees... Read more
On May 16, 2021 I began to develop red, swollen bumps on my bilateral lower legs just below my knees that were very itchy. Every day, these bumps would "move". I would wake up and they would be in different locations on my legs. They progressively worsened to the point that they were covering my thighs, abdomen, and flanks and in spotty areas on my arms, lower legs, back and shoulders. I also would randomly develop swelling of my eyelids (lower or upper), and my lips would swell up to 4-5 times their normal size. I also had noticeable swelling on the inside of my mouth/cheeks.
41 2021-07-17 lymph node pain, lymph node swelling swollen, sore lymph nodes under arms; swollen, sore lymph nodes under arms; This is a spontaneous re... Read more
swollen, sore lymph nodes under arms; swollen, sore lymph nodes under arms; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 41-year-old non-pregnant female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9269, Expiration date: Unknown), via an unspecified route of administration in arm left on 05Feb2021 19:15 as single dose for COVID-19 immunisation in Health Clinic. Medical history included GERD from an unknown date and unknown if ongoing. The patient was diagnosed with COVID-19 prior to vaccination. Patient received unspecified concomitant medication. The patient did not receive any other vaccine in four weeks. The patient had not been tested for COVID-19 since having the vaccine. The patient experienced swollen, sore lymph nodes under arms on 08Feb2021 18:00. The patient did not receive any treatment for events. The outcome of events was not resolved. Follow-up attempts are completed. No further information is expected.
41 2021-07-17 lymph node swelling, neck mass Swollen lymph mode; Tender; Sudden mass (ganglion?) above left collar bone; Sore; This is a spontane... Read more
Swollen lymph mode; Tender; Sudden mass (ganglion?) above left collar bone; Sore; This is a spontaneous report from a contactable consumer, the patient. A 41-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm left on 27Mar2021 at 11:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included anemia. The patient had no known allergies to medications, food, or other products were reported. Concomitant medications included VIT D3 (MANUFACTURER UNKNOWN) 50000 IU one per week, from unknown date for unspecified indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 17:00 the patient experienced swollen lymph node, neck mass, sudden mass (ganglion) above left collar bone, sore and tenderness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the swollen lymph node, neck mass, sore and tenderness was not recovered. No follow-up attempts are needed. No further information is expected.
41 2021-07-17 lymph node swelling Dizziness; Aches; Sweating; Lymph node on the left sideof neck; Fever; Chills; Nausea; Headache; Kne... Read more
Dizziness; Aches; Sweating; Lymph node on the left sideof neck; Fever; Chills; Nausea; Headache; Knee pain; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 18Mar2021 at 16:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, high blood pressure (HBP), penicillin allergy, allergy to nuts and allergy to peaches. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), triamterene/hctz (MANUFACTURER UNKNOWN), montelukast sodium (SINGULAIR) and bupropion hydrochloride (WELLBUTRIN), all for unknown indications from unknown dates. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 21Mar2021 at 12:00, the patient experienced fever, chills, aches, headache, nausea, dizziness, knee pain, sweating and lymph node on the left side of the neck. The patient had taken off from work since 22Mar2021.The patient had messaged the doctor on 24Mar2021 and had not received any reply. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events fever, chills, aches, headache, nausea, dizziness, knee pain, sweating and lymph node on the left side of the neck. The clinical outcomes of the events fever, chills, aches, headache, nausea, dizziness, knee pain, sweating and lymph node on the left side of the neck were not recovered at the time of the report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
41 2021-07-17 lymph node swelling The morning following my injection I had very bad left armpit pain and I could actually feel a swoll... Read more
The morning following my injection I had very bad left armpit pain and I could actually feel a swollen lymph node. This pain was worse than the injection site pain. As the morning went on I developed a heaviness in my chest-which was worse when I took a deep breath-and palpitations. I also had all the typical symptoms like lightheadedness, body aches, fatigue, nausea, a low grade fever and headache. All the symptoms resolved after 1-2 days except for the chest heaviness and occasional palpitations. After 6 days of no relief of the chest symptoms I went to my local clinic. My heart rate was elevated but the Dr there told me I did not have a PE based on my symptoms. He said to go to the ER if I wanted to have a CT scan of my chest to rule out a PE for peace of mind. The next morning I saw my primary doctor since I didn't get any real answers of what my symptoms were. Again my heart rate was elevated. She did an EKG which did not show any palpitations but she diagnosed my symptoms as peri/myocarditis and I was prescribed 5-10 days of naproxen.
41 2021-07-17 peripheral swelling I have experienced swelling in both ankles and feet. There is pain in the left inner ankle but not t... Read more
I have experienced swelling in both ankles and feet. There is pain in the left inner ankle but not the right. It hurts to touch and with movement, but I can twist/move it freely. There has been no injury to neither foot/ankle. The swelling reduces with rest and elevation but has not gone completely away since it began.
41 2021-07-17 swelling face Swelling of face, lips & tongue.; Swelling of face, lips & tongue.; Swelling of face, lips & tongue.... Read more
Swelling of face, lips & tongue.; Swelling of face, lips & tongue.; Swelling of face, lips & tongue.; Redness & intense burning of face, neck & chest; burning of face, neck & chest; Chest os tight; Watery & dry eyes; Watery & dry eyes; Abdominal pain on & off; Joint pain first few days.; Sore throat; This is a spontaneous report received from a contactable consumer (patient). A 41-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in left arm on 05Apr2021 at 03:15 PM (vaccinated at the age of 41 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included endometriosis from an unknown date and unknown if ongoing. Allergies to medications, food, or other products includes Levaquin, latex & shellfish. The patient was received Estradiol within 2 weeks of vaccination, taken for an unspecified indication, start and stop date were not reported. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Apr2021 at 04:00 PM, the patient was experienced swelling of face, lips & tongue. Redness & intense burning of face, neck & chest (since date of vaccine-5 days so far). Chest os tight. Abdominal pain on & off. Watery & dry eyes. Joint pain first few days. Sore throat. The adverse event result doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event with Saw pcp. The patient was not diagnosed with COVID-19, prior to vaccination and since the vaccination, the patient was not tested for COVID-19. Outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
41 2021-07-17 swelling face Facial Swelling; Fever; Headache; Nausea; This is a spontaneous report from a non-contactable consum... Read more
Facial Swelling; Fever; Headache; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 41-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. The patient had previously received penicillin (MANUFACTURER UNKNOWN) and experienced allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient experienced facial swelling, fever, headache and nausea. The patient did not receive any treatment for the adverse events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events facial swelling, fever, headache and nausea were resolving at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained
41 2021-07-17 swelling, peripheral swelling, swelling face This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non pregnant fe... Read more
This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the right arm on 13Mar2021 at 13:15 (at the age of 41-years) as a single dose for COVID-19 immunisation. Medical history included pancreatitis, high blood pressure and dizziness. Concomitant medications included prednisone (MANUFACTURER UNKNOWN) 1 dose the day after and losartan (MANUFACTURER UNKNOWN) for unknown indication. The patient previously received tobramycin (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 at 18:00, the patient experienced face, neck, lips, and hands swollen, trouble swallowing and increased dizziness. The adverse events resulted in emergency room or urgent care visit. On 22Mar2021, post vaccination, the patient had nasal swab test and was tested negative. The patient did not receive any treatment for the adverse events swollen face, swollen neck, swollen lips, swollen hands, trouble swallowing and increased dizziness. The clinical outcomes of the events swollen face, swollen neck, swollen lips, swollen hands, trouble swallowing and increased dizziness were recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
41 2021-07-20 white blood cell count increased I experienced chest and lung pain and had to be immediately rushed to the hospital. The ER doctor or... Read more
I experienced chest and lung pain and had to be immediately rushed to the hospital. The ER doctor ordered tests to look at my lungs to find out why I was experiencing an adverse reaction the vaccine. I was admitted to the hospital and was there for 4 days. My lungs were bleeding and there was bacteria in them. I am getting ready to have another series of tests done on my lungs and my doctor suspects that the vaccine is what caused my lungs to flare up. My breathing is really bad and the pulmonologist stated that my lungs are continuing to bleed. I am on 4 nebulizers and other medications.
41 2021-07-21 lymph node swelling Enlarged supraclavicular lymph node on L side noted 4/1/21 (size of a pea), non-painful.; This is a ... Read more
Enlarged supraclavicular lymph node on L side noted 4/1/21 (size of a pea), non-painful.; This is a spontaneous report from a contactable healthcare professional. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration in the left arm on 26Mar2021 at 07:45 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy nos. The patient received other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced enlarged supraclavicular lymph node on L side noted 4/1/21 (size of a pea), non-painful. It was unknown if the patient received treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event enlarged supraclavicular lymph node on L side noted 4/1/21 (size of a pea), non-painful was not resolved at the time of reporting. No follow-up attempts are needed. No further information is expected.
41 2021-07-21 swollen extremities Facial edema and upper lip edema Multiple episodes of edema in different body parts (hands, face)
41 2021-07-22 lymph node pain, lymph node swelling Heat and swelling at injection site 12 hours post vaccine continuing until at least 23 hours post va... Read more
Heat and swelling at injection site 12 hours post vaccine continuing until at least 23 hours post vaccine when reported Pain and weakness in right hand 13 hours post vaccine continuing until at least 23 hours post vaccine when reported Heart racing and trouble breathing 16 hours post vaccine intermittent symptoms coming and going continuing until at least 23 hours post vaccine when reported Nausea 17 hours post vaccine intermittent symptoms coming and going continuing until at least 23 hours post vaccine when reported Swollen and painful lymph node in right armpit 21 hours post vaccine continuing until at least 23 hours post vaccine when reported Pain in right breast 21 hours post vaccine continuing until at least 23 hours post vaccine when reported
41 2021-07-22 lymph node swelling Feel discomfort; Swollen lymph node under arm; This is a spontaneous report from a non-contactable c... Read more
Feel discomfort; Swollen lymph node under arm; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6206) via an unspecified route of administration in the left arm on 12Mar2021 at 11:00 (at the age of 41-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 02Apr2021 at 11:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient did not have medical history. The patient did not have a history of allergies to medications, food or other products. Concomitant medication taken within two weeks included diazepam; isopropamide iodide (VALTRAX) received on unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On unknown date in Mar2021, the patient experienced swollen lymph node under arm where vaccine was administered. It was reported that, after first dose lump appeared 3 to 4 days later and got bigger and experienced discomfort for almost two weeks and still it was a small lump (at the time of this report). On 02Apr2021 after second dose within 8 hours, the patient experienced swollen lymph node. It was reported that lump was swollen, size of baseball and the patient felt discomfort when she put her arm down by side. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events swollen lymph node under arm and feel discomfort were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
41 2021-07-25 lymph node swelling, peripheral swelling Swelling in lymph nodes and arm. Very lethargic, bad headache, tired, whole body aches
41 2021-07-25 lymph node swelling I experienced low heart rate, chest pains, tiredness and my right lymph node is swollen.
41 2021-07-26 peripheral swelling The joints in my hands and feet keep swelling. They ache horribly. Nothing really helps.
41 2021-07-27 c-reactive protein increased, anaphylactic reaction, swelling Anaphalactic Reaction treated by double dose of hydroxyzine on site at clinic. Throat swelling - ha... Read more
Anaphalactic Reaction treated by double dose of hydroxyzine on site at clinic. Throat swelling - hard to swallow all day - went away next day. 4/22 - Legs heavy, tired for two days. May 8: Spasms/Twitching - Left side of head behind ear, which continues to this day. May 10 - Hearing loss - ear muffled, full feeling; Entire left side head felt inflamed, swollen at base of skull. Dr. sent bloodwork which showed high inflammation marker. Said I needed temporal artery biopsy. Consulted with surgeon that day and scheduled for biopsy on 5/11, which came back negative for arteritis. During surgery recovery started 16 day prednisone taper after inflammation still high crp levels. this helped my ear in the long run. still have tinnitus. Since 5/10 I've been seeing Drs for all left side symptoms of: tinnitus, nerve pain, sharp stabbing pains in head, moving nerve pains in head, base of skull pain, left side head soreness - dull, achy, burning, sharp - ever changing in nature, insomnia, new allergic reactions to different foods, anxiety, new electrical shocking/zaps in left toes and in front teeth, PTSD from th severity and frequency of symptoms, eye floaters/damage, spasms/twitching. Been in physcial therapy for 6 weeks. New nerve pains in limbs. Lightheadedness and some speech changes. Similar to COVID long haulers - never had COVID.
41 2021-07-27 peripheral swelling She was calling to see if she could get more info about side effects she is experiencing.; eye twitc... Read more
She was calling to see if she could get more info about side effects she is experiencing.; eye twitching; rash on her forehead, below her lip, on her leg; itching; pain; swelling in her arm; headache; fatigue; vaginal spotting; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 14Mar2021 as DOSE 1 (age at vaccination: 41), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she was calling to see if she could get more info about side effects she is experiencing, eye twitching, rash on her forehead, below her lip, on her leg, itching, pain, swelling in her arm, headache, fatigue and vaginal spotting on an unspecified date. Caller asking if she should seek medical advice. Outcome of all the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained
41 2021-07-27 swelling face The next morning I woke up to both of my lips very swollen and painful; Later that day, my cheeks al... Read more
The next morning I woke up to both of my lips very swollen and painful; Later that day, my cheeks also started swelling and painful; Later that day, my cheeks also started swelling and painful; Approx 20 hours after receiving my 2nd dose, I felt a swelling in my lip in one spot, upper lip right side, just off center of my mouth. The next morning I woke up to both of my lips very swollen; This is a spontaneous report from a contactable consumer (Patient). A 41-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186 ), dose 2 intramuscularly, administered in Deltoid Right (Right arm) on 18May2021 at 15:15 (Age at vaccination: 41 years) as single dose for covid-19 immunisation. Vaccine Facility Type was Doctor's office/Urgent care. Patient medical history was none. Patient had none known allergies. The patient's concomitant medications were not reported. Patient received dose 1 on 27April2021 at 15:15, intramuscularly in right arm with lot number Ew0175. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Patient did not received any other medications within 2 weeks of the vaccination. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient stated approx 20 hours after receiving her 2nd dose, she felt a swelling in her lip in one spot, upper lip right side, just off center of her mouth on 19May2021 at 11:00, the next morning on 20May2021, she woke up to both of her lips were very swollen and painful. Looked like she had major fillers done. she could hardly drink. later that day, her cheeks also started swelling and painful. Cheeks Felt similar to a sinus infection but in her whole cheeks on the bone area, almost ears to nose vs just sinus area. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient received steroids for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date. Device Date was reported as 20May2021. Physician consider the Pfizer product had a casual effect to the adverse event. The outcome of the events was unknown.
41 2021-07-28 guillain-barre syndrome Guillain-Barre syndrome; Fever; Chills; Muscle ache; This is a Spontaneous report from a contactable... Read more
Guillain-Barre syndrome; Fever; Chills; Muscle ache; This is a Spontaneous report from a contactable pharmacist. A 41-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EJ1685 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 09Jan2021 (age at vaccination: 41 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EJ1685 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on an unspecified date, as a single dose for COVID-19 immunization. Vaccine was not administered at military facility. Caller was a pharmacist who stated that she was involved in administering the Pfizer COVID-19 vaccines at her work and due to the increase in concerns about Guillain-Barre syndrome developing with the it prompted her to call Pfizer because she remembers 1 patient who was diagnosed with Guillain-Barre syndrome after receiving the second dose on 15Jan2021 and she remembers 2 patients who developed Bell's Palsy after receiving their first doses of the Pfizer COVID-19 vaccines and they were not given the second doses due to these adverse events. On the date of the second dose of the Pfizer Covid 19 Vaccine the patient developed fever, chills, and muscle aches. On 15Jan2021 the patient went to the emergency room and was hospitalized on an unspecified date in Jan2021. The patient was admitted to the hospital for 5 days and treated with IV Ig. The caller stated that the last time that she spoke with the patient, the patient was recovered but was still experiencing some numbness and tingling. The patient had a spinal tap and blood work on 15Jan2021 and 16Jan2021; the caller did not have the results of these tests. The adverse events required a visit to emergency room. The patient was discharged form hospital on an unspecified date in Jan2021. Outcome of the event Guillain-Barre syndrome was recovered on an unspecified date in 2021 and all other events was recovered on 17Jan2021.; Sender's Comments: Based on the information currently available in narrative , a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of reported events of Guillain-Barre syndrome , muscle ache, cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-07-29 axillary mass Pain in left armpit; swelling on left armpit; This is a spontaneous report from a contactable consum... Read more
Pain in left armpit; swelling on left armpit; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8735) via an unspecified route of administration in the left arm on 01May2021 at 16:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not receive any medication within two weeks of vaccination. The patient not had any past medication history. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8734) via an unspecified route of administration in the left arm on 08April2021 at 15:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 20:00, the patient experienced pain in left armpit and swelling in left armpit (axillary mass). The clinical outcome of the event pain in left armpit and swelling in left armpit( axillary mass) was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
42 2021-01-01 peripheral swelling Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue s... Read more
Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue swelling, mild fatigue, sinus pressure , shortness of breath 1 day later: redness injection site, moderate swelling or arm, mild head cold 2 days later: mild fatigue, sinus pressure, pain arm and redness of injection site
42 2021-01-03 swollen extremities After patient received an injection, patient developed fever, body aches, body chills, and injection... Read more
After patient received an injection, patient developed fever, body aches, body chills, and injection site is red and swollen. Patient also mentioned that her arm pit area is also swollen.
42 2021-01-03 swelling face Lip and facial area swelling tow days after receiving vaccine.
42 2021-01-04 lymph node swelling Lymphadenopathy on left axilla and elbow; This is a spontaneous report from a contactable nurse (pat... Read more
Lymphadenopathy on left axilla and elbow; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 16Dec2020 at 11:45 (at the age of 42-years-old) as a single dose for Covid-19 vaccination. Medical history included cold urticaria and iritis from an unknown date. The patient did have allergies to the medications Sulpha, levaquin, cipro, and macrobid. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for an unknown indications from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Dec2020 at 08:00, the patient experienced Lymphadenopathy on left axilla and elbow. Therapeutic measures were not taken for the Lymphadenopathy on left axilla and elbow. The clinical outcome of the event Lymphadenopathy on left axilla and elbow was recovered on an unknown date in Dec2020. Information on the lot/batch number has been requested.
42 2021-01-04 lymph node swelling I had fatigue and body aches for 4 days I woke up Sunday morning and I had a huge swollen lymph node... Read more
I had fatigue and body aches for 4 days I woke up Sunday morning and I had a huge swollen lymph node the size of a golf ball at the base of the right side of my neck that lasted for 2 days, I was put on ogmentin for 5 days and it went away after that
42 2021-01-04 swelling face Swelling on right side of face, tingling, numbness up to Right eye and into Right side of neck (st... Read more
Swelling on right side of face, tingling, numbness up to Right eye and into Right side of neck (started 1/4 - lasted approximately 10 hours)
42 2021-01-06 lymph node swelling Mild axillary lymphadenopathy on left side ( same side as the site of administration) starting on da... Read more
Mild axillary lymphadenopathy on left side ( same side as the site of administration) starting on day 9 progressing to mild lymphangitis by day 11 extending to mid arm. Resolved by day 20 without any treatment
42 2021-01-06 swelling Patient reported swelling, redness, itching, hot to touch above her left breast. Patient took diphe... Read more
Patient reported swelling, redness, itching, hot to touch above her left breast. Patient took diphenhydramine
42 2021-01-07 anaphylactic reaction Started with hives approximately 15 minutes after and then went into full Anaphylaxis. Required epi ... Read more
Started with hives approximately 15 minutes after and then went into full Anaphylaxis. Required epi and Benadryl.
42 2021-01-07 lymph node swelling, axillary mass Lymph node swelling right axillary
42 2021-01-07 lymph node swelling 3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint... Read more
3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint pain, chills, shot area is swollen, nausea, lymph nodes swollen and sensitive to touch. Face is tender. SOB with movement and dizziness. Patient is a cancer survivor and she said that it feels like she had a chemo treatment.
42 2021-01-07 swelling face Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asth... Read more
Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse. A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization. Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
42 2021-01-08 lymph node swelling, axillary mass 2nd dose reaction included extreme joint pain to where standing is painful in my feet, 103.4F temp w... Read more
2nd dose reaction included extreme joint pain to where standing is painful in my feet, 103.4F temp with while alternating Tylenol/Advil q4h, large swollen lump in armpit and below clavicle which are extremely painful (on side of body where vaccine was administered). Stiff neck and jaw, severe headache, mild dizziness (was much worse after the 1st dose), nausea, fatigue.
42 2021-01-08 lymph node swelling Lymphadenopathy of left axilla and left side of neck
42 2021-01-08 swelling Rash and swelling around mouth, eyes, and behind ears
42 2021-01-09 lymph node swelling, swollen extremities Injection site is very red, sore, and has a very large bump. Pain spread to armpit area which is enl... Read more
Injection site is very red, sore, and has a very large bump. Pain spread to armpit area which is enlarged and bumpy.
42 2021-01-10 swelling Headache, Bleeding, Myalgia, Arthralgia, Angioedema, Sweats/Chills with normal temperature, ipsilat... Read more
Headache, Bleeding, Myalgia, Arthralgia, Angioedema, Sweats/Chills with normal temperature, ipsilateral (left) axillary pain w/o lymphadenopathy erythema, or rash. Epistaxis, eyelids puffy. Extreme fatigue Narrative: Chills fatigue, body aches, no fever, no hot flashes, HA. Left (ipsilateral to injection) axillary pain but no palpable nodes. Ipsilateral axilla. skin feels raw, but looks fine. Awoke 0400 with nose bleed. Puffy eye. Warm compress. No help.
42 2021-01-10 lymph node swelling, lymph node pain About 48 hours after vaccination, I developed tender and swollen lymphadenopathy from my axilla down... Read more
About 48 hours after vaccination, I developed tender and swollen lymphadenopathy from my axilla down the bottom of my arm to my elbow on my right side. This is the same side the injection was given. The injection site is no longer tender to touch but it is difficult to raise my arm and hold it straight due to discomfort. My arm is visibly swollen compared to my left arm. I can feel shotty lymph nodes down my arm.
42 2021-01-10 lymph node swelling Fever up to 102 degrees, severe body aches, uncontrollable shivering, lymphadenopathy, right arm pai... Read more
Fever up to 102 degrees, severe body aches, uncontrollable shivering, lymphadenopathy, right arm pain
42 2021-01-10 peripheral swelling, swelling face Received vaccine on 1/5, began having swelling in bilateral hands and lower extremities on 1/7, alon... Read more
Received vaccine on 1/5, began having swelling in bilateral hands and lower extremities on 1/7, along with fatigue. On 1/8 she reports new swelling started in her face (eyes and cheeks). Swelling has not improved today and fatigue has worsened.
42 2021-01-10 peripheral swelling Arm swelling, Red spot at site of vaccine. Diarrhea, Pain Scalp pain.
42 2021-01-11 lymph node swelling, lymph node pain joint pain and muscle; joint pain and muscle; Vertigo; an itchy rash bilaterally on her arms; develo... Read more
joint pain and muscle; joint pain and muscle; Vertigo; an itchy rash bilaterally on her arms; developing swollen, tender, and hard lymph nodes under the Left subclavian area/ swollen left subclavian lymph nodes; developing swollen, tender, and hard lymph nodes under the Left subclavian area; extreme fatigue; Runny nose; Headache; This is a spontaneous report from a contactable nurse (RN) reporting for herself. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 23Dec2020 h 09:00 intramuscularly in left deltoid (left arm) lot number: EK5730 at single dose for COVID-19 immunization. Concomitant medications were not provided. Patient stated that she has had double mastectomy, and missing a lot of lymph nodes, states she got the first dose of Pfizer Covid vaccine on 23Dec2020, states it made her left subclavian lymph nodes swollen and hard. States that when she gets the flu vaccine at her hospital every year, she gets swollen lymph nodes ever since she had a double mastectomy and chemotherapy. She originally was wondering if she could get the vaccine in another large muscle group. States she even went as far as to cross reference flu shot ingredients with the Pfizer Covid ingredients to see if something in the vaccines were causing the swollen lymph nodes but was unable to come to any conclusion, the only think in common is the Sodium Chloride and she does not feel like that would cause any issue. States the swollen lymph nodes occurred after the Sanofi brand flu vaccine (no other information known or provided). Patient is on day 15 post vaccination and they are still swollen and hard, she is wondering if there is any data on how long this side effect can last. She made an appointment with her oncologist, she knows that the swollen lymph had the first dose, lymph nodes are still swollen and hard, knows it can cause swollen lymph nodes but wants to know what is the typically length of the event. Patient also experienced other side effects, on 30Dec2020 (last week), she developed vertigo that lasted through the weekend intermittently, states she at first thought she was having a stroke. States it seems to have subsided as of 05Jan2021 (yesterday). Patient also reported she had an itchy rash twice as part of her side effects reported from the COVID 19 vaccine. She noticed an itchy rash and it went away but she is unsure exactly the day or time. Stated she definitely remembered the rash on 28Dec2020 as she took pictures. It was gone in about three hours on the same day. She did not treat the rash because it was gone and not itching. The rash came and went and had not come back. It was mostly on the bends of the arms, bilateral arms. Patient reported developing swollen, tender, and hard lymph nodes under the Left subclavian area the day after the injection, on 24Dec2020. They were not as tender at the time of the report but were continuing and this was 15 days from her vaccination. Patient also experienced an itchy rash bilaterally on her arms that occurred twice and only lasted a few hours each time, onset date reported as 25Dec2020. She was advised to take diphenhydramine hydrochloride (BENADRYL) for it however she did not take it. On 23Dec2020 patient experienced headache. On 24Dec2020 patient experienced extreme fatigue, swollen left subclavian lymph nodes and runny nose. On 30Dec2020 patient experienced joint pain and muscle and vertigo. The events headache, experienced extreme fatigue, swollen left subclavian lymph nodes, runny nose, joint pain and muscle and an itchy rash bilaterally on her arms were considered serious as medically significant events. Patient had not recovered from swollen left subclavian lymph nodes, joint pain and muscle, extreme fatigue and swollen, tender, and hard lymph nodes under the Left subclavian area, she was recovering from headache, runny nose and vertigo and recovered completely from an itchy rash bilaterally on her arms on 28Dec2020.; Sender's Comments: The Causality between the events, headache, experienced extreme fatigue, swollen left subclavian lymph nodes, runny nose, joint pain and muscle and an itchy rash bilaterally on her arms, and the administration of the COVID 19 vaccine cannot be denied based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
42 2021-01-11 lymph node swelling Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling and pain occurring still 4 days post vaccin... Read more
Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling and pain occurring still 4 days post vaccine, visit with PCP who prescriped 800mg ibuprofen 3x/day and rest, no work. Symptoms began 7am on 1/9/21. Fever, chills, headaches, body aches . symptoms began 9am on 1/9/21 and lasted 24 hours. utilized tylenol to control fever. Low grade fever until 3pm on 1/10/21 - more than 24 hours after symptoms began
42 2021-01-11 lymph node swelling 1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things w... Read more
1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things without feeling wiped out . 3 Advil did nothing- sat 1/9. Next day felt better.- sun 1/10. That evening low grade fever 99.6 and achy again., mostly eyes and head. Went to bed. Monday okay. But noticed right armpit a pit puffy.- same side as injection. Tuesday 1/12 woke up at 6:00am and had dull joint/bone pain bilaterally. Ranging from neck ache, to sternum/upper back, shoulders, triceps. Injection site still sore- slightly red off to the side. Did some stretches in bed and eventually got up. I am very in tune with my body- something is off. I never wake up feeling ?bad?. Fit, healthy and active normally. Almost like a bad nights sleep with a poor mattress but only affected my upper body. Took two Advil and hot shower- feel better but can tell something doesn?t feel right.
42 2021-01-11 lymph node swelling Flu like symptoms, syncope, lymphadenopathy, nausea, fatigue, weakness.
42 2021-01-11 swollen extremities Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling, began 1/9/21 at 7am, it is still swollen, ... Read more
Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling, began 1/9/21 at 7am, it is still swollen, had a PCP visit in clinic, off work for 3 days and prescribed anti-inflammatory. Fever, aches, chills, headaches, began 1/9/21 at 9am. Resolved within 24 hours. used tylenol as bottle dosage. Low grade fever until 1/10/21 at 3pm. used aleve as bottle dosage.
42 2021-01-12 lymph node swelling Chills; Low grade fever; Nausea; Pain; Swollen lymph nodes in armpit; This is a spontaneous report f... Read more
Chills; Low grade fever; Nausea; Pain; Swollen lymph nodes in armpit; This is a spontaneous report from a contactable Healthcare Professional (patient).This 42- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EL3246), via an Intramuscular route of administration, on 06Jan2021 09:15AM (at the age of 42-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient did not have any allergies to medications, food, or other products. Medical history included: Mitral valve prolapse. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EH9899) via an Intramuscular route of administration, on 18Dec2020 at 03:30 PM (at the age of 42-years-old) as a single dose for COVID-19 vaccination, anatomically located on the right arm. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jan2021 at 01:30 AM, she experienced chills, low grade fever, nausea, pain, and swollen lymph nodes in armpit. The patient did not receive treatment for the events. The clinical outcome of the events chills, low grade fever, nausea, pain, and swollen lymph nodes in armpit was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
42 2021-01-12 lymph node swelling Large painful lump under right arm in the armpit about breast level.
42 2021-01-12 lymph node swelling Injection site raised and pain upon touch - started 1/11 evening after vaccine dose 2. Then on 1/12 ... Read more
Injection site raised and pain upon touch - started 1/11 evening after vaccine dose 2. Then on 1/12 1600 noticed under arm swelling and discomfort - thinking it's lymphadenophathy just on left side. Took ibuprofen and no changed as of 1/13 am
42 2021-01-12 lymph node swelling Crushing joint pain began late evening on 1/10/21 with swollen lymph nodes under the arms.
42 2021-01-12 swelling face 2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep chok... Read more
2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took 50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged, Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I already had. I also continued my normal HS antihistamines. I had SOB on exertion, progressively better from the 6th-10th with it mostly resolved to yesterday. Body aches have continued but also progressively better. Yeasterday1/12/21 the Rx of prednisone was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg again and inhaler used. I have an appointment today to seek further care at my primary doctor's office. Asthmnax used again this morning as well, only mild tightness in the throat currently with mild body aches this whole time.
42 2021-01-12 swelling wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling an... Read more
wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling and pain thursday night-more dyspnea, joint pain, general swelling, joint pain (took tylenol worked shift as nurse) friday-fatigue, joint swelling, general swelling, dyspnea blanching (took tylenol and ibuprofen worked shift as nurse) saturday-extreme fatigue, joint pain and swelling, general swelling, dyspnea sunday, facial swelling, petichiae on legs and back, joint, pain and swelling, fatigue requiring visit to hospital
42 2021-01-13 lymph node pain Monday, 1/11/2021 (8:30a): 2nd dose administered ? I felt fine the rest of the day and when g... Read more
Monday, 1/11/2021 (8:30a): 2nd dose administered ? I felt fine the rest of the day and when going to bed. Overnight, I started to experience chills followed by extreme perspiration and weakness to the point that I struggled to open a bottle of water I had by my bed. Tuesday, 1/12/2021: Headache, weak and tired but attempted to work. I had to leave shortly after arriving because my symptoms were becoming progressively worse to the point I almost passed out from standing. Upon arriving home, I started to experience nausea and vomiting x 3. Intense chills followed by the extreme perspiration still existed. Most of these symptoms subsided by 9:30p that evening. Wednesday, 1/13/2021: Intense headache, weakness and dizziness. Of note, my left underarm/armpit (the arm where the vaccine was administered) is sensitive to touch.
42 2021-01-13 lymph node swelling acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling ... Read more
acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling of first 3 fingers in left hand (median nerve distribution); tingling of first 3 fingers in left hand (median nerve distribution).; significant cervical lymphadenopathy; painful neck; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old adult female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number: EJ1686, via an unspecified route of administration, in left arm, on 06Jan2021 at 9:52 am, at 42-years of age, at single dose for COVID-19 immunization. The patient was vaccinated in Hospital. Medical history included overweight and no known allergies. Concomitant medications included the second dose of HPV VLP vaccine rL1 4v (yeast) (GARDASIL) received in left arm on 18Dec2020 and ergocalciferol (Vitamin D). On 06Jan2021 by 10:05 the patient experienced acute onset nausea, diaphoresis, presyncope and concomitant left arm weakness/flaccid arm with numbness and tingling of first 3 fingers in left hand (median nerve distribution). The patient informed vaccine staff of symptoms and advised ongoing observation. Flaccid arm/weakness/numbness continued for more than 24 hours, although at the time of the report it was slowly improving. At the time of the report the patient further reported significant cervical lymphadenopathy and painful neck (specific onset date not provided - captured as Jan2021). The events were reported as non-serious. The reporter specified that the injection was not given anywhere near brachial plexus. At the time of the report the events "Left arm weakness" and "Left arm numbness" were resolving, the outcome of the events "Nausea", "Diaphoresis", "Presyncope", "Tingling of first 3 fingers in left hand", "Cervical lymphadenopathy" and "Painful neck" was unknown.
42 2021-01-13 lymph node swelling Tingling and numbness on the left side especially the fingers and toes(1/13/21). Burning sensation (... Read more
Tingling and numbness on the left side especially the fingers and toes(1/13/21). Burning sensation (1/13/21)on the left armpit and later on axillary lymph edema(1/14/21)and heaviness of the arm. Itching and joint pain on left arm. Muscle pain ,cold and injection site pain since the evening of 1/12/21.
42 2021-01-13 lymph node swelling Patient reports soreness to the arm, she has a lymph nodes are the size of a "golf ball". This is o... Read more
Patient reports soreness to the arm, she has a lymph nodes are the size of a "golf ball". This is on the right side. No other findings
42 2021-01-13 swelling face Patient developed tight feeling in throat, difficulty swallowing, diaphoretic, clammy skin and facia... Read more
Patient developed tight feeling in throat, difficulty swallowing, diaphoretic, clammy skin and facial swelling around eyes.
42 2021-01-14 axillary mass Right swollen painful lump in armpit; This is a spontaneous report from a contactable healthcare pro... Read more
Right swollen painful lump in armpit; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration on 26Dec2020 17:00 (reported as 5:00 PM) at single dose on the right arm for COVID-19 immunisation. Medical history included asthma, thyroid cancer 2 years ago (2019) and shellfish allergies. The patient's concomitant medications were not reported. The patient previously took gadoxetate disodium (EOVIST) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. COVID-19 vaccine was administered in the hospital. The patient experienced right swollen painful lump in armpit on 30Dec2020. It was unknown if treatment was received. The event resulted in doctor or other healthcare professional office/clinic visit. The event was assessed non-serious. Outcome of the event was recovered with sequel on an unspecified date (reported as "Recovered with lasting effects"). The patient has not been tested for COVID-19 since the vaccination. Information about lot/batch number has been requested.
42 2021-01-14 lymph node pain, lymph node swelling Swollen lymphnode approx 1 inch in diameter with swelling around the node approximately 2 inches in ... Read more
Swollen lymphnode approx 1 inch in diameter with swelling around the node approximately 2 inches in diameter. Pain. Was directed by my PCP,s walk-in clinic to report.
42 2021-01-14 lymph node pain Bilateral armpit lymph node pain and bilateral groin lymph node pain 7 days after vaccine; This is a... Read more
Bilateral armpit lymph node pain and bilateral groin lymph node pain 7 days after vaccine; This is a spontaneous report from a contactable nurse (patient herself). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231, expiry date not reported), intramuscular in the right arm on 04Jan2021 09:00 at single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included norethisterone (CAMILA). The patient previously took erythromycin and experienced allergies. On 10Jan2021 at 2:00, the patient experienced bilateral armpit lymph node pain and bilateral groin lymph node pain 7 days after vaccine. No treatment was received for the adverse events. Clinical outcome of the events was recovering.
42 2021-01-14 lymph node swelling, lymph node pain, swelling I had 100.2F at night and significant chills and fatigue and my fever went on until Thursday. I had ... Read more
I had 100.2F at night and significant chills and fatigue and my fever went on until Thursday. I had a pretty big immune response. the right side of my face got numb into my neck and my chest and I feel my lymph nodes turned into marbles. I also have swelling in my lymph nodes, my neck and my back. I sought medical care on Thursday due to the swelling and my PCP does not have a clue what to do.
42 2021-01-14 lymph node swelling, lymph node pain fatigue and very swollen tender lymph node under left arm -same arm as shot received
42 2021-01-14 lymph node swelling Nausea and headache the evening of the vaccine. Chills, headache, aches and pains, nausea late that... Read more
Nausea and headache the evening of the vaccine. Chills, headache, aches and pains, nausea late that night into the early morning. Day 6 after receiving vaccine, lymph nodes swollen. Worsened on day 7 and 8. Day 8 after vaccine noticed hives on back. Still have headache and nausea off and on.
42 2021-01-14 lymph node swelling Right axillary swelling, pain and warmth, redness at the injection site. Treatment: Tylenol, heat. O... Read more
Right axillary swelling, pain and warmth, redness at the injection site. Treatment: Tylenol, heat. Outcome: Able to move extremity with difficulty. Able to complete ADLs with out difficulty . No improvement with treatment. Will continue to monitor.
42 2021-01-14 peripheral swelling, swelling, lymph node swelling 2nd Shot given 21 days after the first shot. Next day seemed like normal side effects. Day 2 those e... Read more
2nd Shot given 21 days after the first shot. Next day seemed like normal side effects. Day 2 those effects went away low grade fever, aches, but had a knot axillary lymph node, and my arm hurt worse then the swelling spread to my chest and neck. No trouble breathing. I went to the ER because the swelling was getting worse and they did a CT scan and gave me IV fluids. The CT scan revealed swollen lymph nodes.
42 2021-01-14 swelling face After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Conti... Read more
After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Continued with paresthesias in lips, tongue, mouth, fingers, legs, and toes. 2-3 hours after administration, developed lip swelling, facial swelling, and swelling of tongue. Zyrtec and tylenol were given. This improved but was still present the next day. At 18 hours following administration, developed rigors, fevers (Tmax 103), severe myalgias, nausea, vomiting, diarrhea, and abdominal pain. These persisted for another 18 hours.
42 2021-01-14 swelling Swelling red tender and very itchy.
42 2021-01-16 lymph node swelling "I received my 2nd Covid vaccine on the morning of 1.14.21 in my left arm. Early yesterday morning I... Read more
"I received my 2nd Covid vaccine on the morning of 1.14.21 in my left arm. Early yesterday morning I awoke with chills and sweats. No fever. Felt crummy all day. Today I have left shoulder and arm pain, swelling in my left armpit and under my arm. I also have some numbness and tingling through my arm down to my hand. I have a hard knot at the injection site but its not red. I also continue to have occasional chills."
42 2021-01-16 swollen extremities, peripheral swelling Severe pain/swelling on R upper arm, R lateral breast/axilla and R side of the neck starting the mor... Read more
Severe pain/swelling on R upper arm, R lateral breast/axilla and R side of the neck starting the morning of 1/14/21. Pain got steadily worse to the point of full body myalgias, severe fatigue/weakness and severe nausea. Almost passed out at work and ended up being bedridden for the rest of the day on 1/14 and all day 1/15 and 1/16. Also had hematuria that developed on 1/15. Went to urgent care clinic on 1/16 and received one bag of IV fluids and zofran for the nausea. CBC, CK, CMP all normal but 1+ hematuria on U/A. Symptoms finally improved on 1/17
42 2021-01-17 lymph node swelling Malaise, headache, muscle aches and all over body pain, fever of 101 (I think higher but that was hi... Read more
Malaise, headache, muscle aches and all over body pain, fever of 101 (I think higher but that was highest documented), arm pain in the arm I got the shot. I took Tylenol every 6 hrs for about 36 hrs. My fever "broke" and didn't return in the middle of the night on day 2. After that (so on day 2) my arm is still sore and I developed a red swollen, itchy rash about the size of my fist on my shoulder. I also have lymphadenopathy in the arm pit area that is making the whole arm and down that side sore and painful.
42 2021-01-18 lymph node swelling 24 hours from injection she developed an 'apple' sized swelling of her left axillary lymph nodes whi... Read more
24 hours from injection she developed an 'apple' sized swelling of her left axillary lymph nodes which is painful and visible. No fever, redness or red streaking
42 2021-01-18 swelling mild redness; mild swelling; itchy; burning; swelling to the eye; mild rash around her left eye; Thi... Read more
mild redness; mild swelling; itchy; burning; swelling to the eye; mild rash around her left eye; This is a spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the second dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 08Jan2021, 10:45 AM on Right arm at single dose for covid-19 immunisation. Medical history included juvaderm under her eye approximately 1 year and half to two years ago. Prior to vaccination, the patient did not diagnose with COVID-19. No Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 42-year-old on an 18Dec2020, 11:15 AM on Right arm at single dose for covid-19 immunisation. Day after the 2nd dose, the patient had a mild rash around her left eye only on 09Jan2021. 3rd day (11Jan2021) swelling to the eye. The day of this report is 4 days post vaccine (12Jan2021), the patient mild redness mild swelling but remain itchy and burning. The patient did not report to her dr as the symptoms seem to be resolving on its own. No covid tested post vaccination. No treatments were received. Outcome of the events was recovering. Information on the lot/batch number has been requested.
42 2021-01-19 lymph node swelling, lymph node pain Swollen lymph node under left arm- dime size, hard to touch, tender to touch
42 2021-01-19 lymph node swelling Tested positive for Covid/had the (Covid) infection; Tested positive for Covid/had the (Covid) infec... Read more
Tested positive for Covid/had the (Covid) infection; Tested positive for Covid/had the (Covid) infection; Swollen lymph nodes under my right arm; This is a spontaneous report from a contactable nurse. This 42-year-old female nurse (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: nurse stated she thought she had a lot# it looked like EK5703), via unspecified route at right deltoid on 21Dec2020 at single dose for COVID-19 immunization. Medical history included blood pressure (patient had taken blood pressure medicine but hadn't taking currently because her blood pressure was being controlled). Concomitant medications included unspecified vitamins. Patient was tested positive for Covid on the 29Dec2020. She stated she didn't know about causality, she was saying no but she did have swollen lymph nodes under the right arm before getting sick (Dec2020), now she thought that might get from her vaccination but in her understanding she could get it from Covid so, she couldn't answer that, she tested positive, she didn't think it's from vaccination but her concern was because she had got the vaccination the first one then had the (Covid) infection and right now she should get the second one or not. Regarding treatment, patient stated she was taking methylprednisolone sodium succinate (SOLU-MEDROL) and salbutamol (ALBUTEROL) inhaler, taking over the counter Vitamin D3, Zinc and Vitamin C and acetylsalicylic acid (ASPIRIN). Patient reported she did go to the physician office/ emergency room. Outcome of events was unknown.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (8 days in this case). However, a causal relationship between events "Tested positive for Covid/had the (Covid) infection" (coded to Drug ineffective / COVID-19) and swollen lymph nodes and BNT162B2 vaccine cannot be completely excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-01-19 swelling Pt with pain and swelling of the axilla that started about 12 hours after vaccine administration.
42 2021-01-20 lymph node pain, lymph node swelling Tiredness; muscle and joint pain; muscle and joint pain; injection site pain; nausea; multiple swoll... Read more
Tiredness; muscle and joint pain; muscle and joint pain; injection site pain; nausea; multiple swollen lymph nodes in the side of neck that are painful and the size of llama beans, nickels and dimes; multiple swollen lymph nodes in the side of neck that are painful and the size of llama beans, nickels and dimes; I fell like I have a bad flu; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: Ek5730, intramuscularly in left arm on 18Dec2020 10:30 AM at single dose for COVID-19 immunisation. Facility type vaccine was hospital. Medical history was none, no known allergies. The patient didn't have COVID prior vaccination. Concomitant medication in 2 weeks included ibuprofen, phentermine, paracetamol (TYLENOL), valacyclovir. The patient didn't have other vaccine in four weeks. The patient experienced tiredness, muscle and joint pain, injection site pain, nausea, multiple swollen lymph nodes in the side of neck that were painful and the size of llama beans, nickels and dimes. She felt like she had a bad flu. Adverse events start date was 02Jan2021 08:30 AM. It was unknown if treatment was received for the events. COVID was not tested post vaccination. Outcome of the events was recovering. The patient received the second dose of BNT162B2, lot number: Ek9231, intramuscularly in left arm on 08Jan2021, 06:15 PM.
42 2021-01-20 lymph node swelling Body aches, shaking chills, joint pain, fever and left underarm lymph node enlarged
42 2021-01-20 lymphatic obstruction 14 hours later I woke up seeing black spots and felt trembly. My BP was 187/92 and my pulse was 120.... Read more
14 hours later I woke up seeing black spots and felt trembly. My BP was 187/92 and my pulse was 120. I went home from work and became itchy to my neck and arms . At about 20 hours later I became short of breathe and pulse standing would go up to 140. I rested and continued taking Motrin and Tylenol as suggested . I ate minimally despite nausea . I messaged my Dr the next AM. By that time my glucose was settling down to normal and my Bp and pulse . The headache got worse and I had a pain in my axilla on the same arm I received the vaccine. I developed ?lymphadema? in that area which is sore to touch or move my arm. I reached out to infectious disease Dr at the hospital I work at and he suggested to continue Tylenol and Motrin and wait a week as this is due to vaccine. It is now Day 3 following vaccine and I am yet unable to work. My arm and axilla area is sore and I can?t lift my arm without pain, I have headaches and nausea as well.
42 2021-01-20 peripheral swelling Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and mu... Read more
Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and muscles; Tiredness/felt tired; fast heartbeat; Difficulty breathing; Dizzy; Nausea; Joint pain; Muscle pain; she was not feeling well; swelling and tightness in her left arm; swelling and tightness in her left arm; Injection site redness/redness of her left arm and injection site swelling; Injection site swelling; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in upper left arm, on 08Jan2021 09:25, at single dose, for COVID-19 immunization, in a public health department. There were no medical history and concomitant medications. The patient did not receive prior vaccinations within 4 weeks. The patient reported she received the COVID-19 Vaccine on Friday, clarified as 08Jan2021 at 9:25 in her left upper arm. She stated experiencing a little bit of side effects since receiving the COVID-19 Vaccine. Shortly after receiving the COVID-19 Vaccine, on 08Jan2021, she was not feeling well. She said she had swelling and tightness in her left arm that started approximately a half hour (30 mins) after receiving the COVID-19 Vaccine on 08Jan2021. She then experienced redness of her left arm and injection site swelling on 08Jan2021. On 10Jan2021 (at night), she felt tired, and had tightness of her joints and muscles. She also experienced a fast heartbeat, and difficulty breathing last night, 10Jan2021. She said her dizzy feeling, nausea, tiredness, and joint and muscle pain were persisting at the time of the report. She reported she thought she was feeling fine up until Sunday, 10Jan2021. She stated her new symptoms started in the late afternoon, and the symptoms have stayed into the morning of 11Jan2021. She reported having previously scheduled a doctor's appointment for 22Jan2021 and will speak with her doctor at that time if she continues to have symptoms. The patient declined treatment for the events. The outcome of the events are joint stiffness, muscle tightness, fatigue, dizziness, nausea, arthralgia and myalgia was not recovered; peripheral swelling, musculoskeletal stiffness, heart rate increased and dyspnea were recovering; vaccination site erythema and vaccination site swelling were recovered on an unspecified date; and malaise was unknown.
42 2021-01-21 lymph node swelling Left axilla pain, painful area posterior left axilla, swollen firm lymph nodes to left lateral axill... Read more
Left axilla pain, painful area posterior left axilla, swollen firm lymph nodes to left lateral axilla/ breast, tenderness soreness to left brachial inner elbow up left bicep into axilla
42 2021-01-21 peripheral swelling AFTER INJECTION - ABOUT 10 MINS- SWELLING DOWN THE FOREARM AND WRIST. AT 6:30PM, CHILLS, TEMP 99.1. ... Read more
AFTER INJECTION - ABOUT 10 MINS- SWELLING DOWN THE FOREARM AND WRIST. AT 6:30PM, CHILLS, TEMP 99.1. BY 10PM, TEMP CHILLS ALONG WITH FATIGUE. TOOK ADVIL.
42 2021-01-21 swelling face, lymph node swelling, swollen extremities 12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client ... Read more
12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client improved that evening. 1/20/2021 Four hours after second vaccine dose - Body aches, intense headache over right eye, The evening of the same day - Heaviness to left arm, increased pain to left arm radiating to hands, tightness to the left arm with a feeling of "electricity" in the arm. The pain increased in intensity to the left arm during the night. Unable to sleep due to intense pain to the left arm and axilla. 1/21/2021 In the morning, client experienced abdominal pain and diarrhea once (loose stool). She noted swelling to the left axilla, intense pain, swelling below the left jawline. 1/22/2021 Early morning nausea without emesis, itching of the right forearm and nape of the neck, throbbing pain to left axilla with itching, throbbing to the left ear, which has not been sensitive to pain due to deafness.
42 2021-01-22 anaphylactic reaction Patient was under the 15 minute post-vaccination observation period when she presented with signs an... Read more
Patient was under the 15 minute post-vaccination observation period when she presented with signs and symptoms consistent with an anaphylactic reaction. Facility administered Benadryl, then an EpiPen, and called 9-1-1. Patient was brought to the hospital.
42 2021-01-24 swelling No initial symptoms other than a sore arm when i got my second shot on 1/8. On 1/21/21 started with ... Read more
No initial symptoms other than a sore arm when i got my second shot on 1/8. On 1/21/21 started with hives, uticaria, and mild angioedema that has not yet subsided despite having received treatment. was told it could be a late reaction and that i should report it.
42 2021-01-24 lymph node swelling I have been experiencing swollen lymph nodes in my neck and eye twitching since receiving the shot. ... Read more
I have been experiencing swollen lymph nodes in my neck and eye twitching since receiving the shot. My lymph nodes swelled almost immediately and the eye twitching started days later. I'm still experiencing them a week later.
42 2021-01-24 lymph node swelling Initially was just arm soreness and then 3 days later I woke up and noticed swollen glands on my col... Read more
Initially was just arm soreness and then 3 days later I woke up and noticed swollen glands on my collarbone and on my neck and on the side of my neck on the left side, they were tender and mobile. They got considerably smaller in a week but it took about a 2 weeks and one of them went away I still feel the others. Consulted with PCP who ordered labs. All normal results.
42 2021-01-24 lymph node swelling I had soreness on the injection site and then about a week later I woke up with swollen glands/lymph... Read more
I had soreness on the injection site and then about a week later I woke up with swollen glands/lymph nodes on my left side, on my neck, on my chin and hey were tender and mobile. I consulted with my PCP who ordered some labs but all came normal.
42 2021-01-24 swelling face left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left j... Read more
left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left jaw; face swelling including eyes; left ear and teeth pain; left ear and teeth pain; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; numbness/swelling to left side of face/some numbness and tingling intermittent left arm; numbness/swelling to left side of face; some numbness and tingling intermittent left arm; Left neck stiffnes and pain; Left neck stiffnes and pain; Left arm pain; Headache; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 15Dec2020 15:45 at left arm, at single dose for covid-19 immunization. Medical history included facial paralysis from 2010, ongoing chronic migraine, Known allergies was None. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY); ibuprofen; paracetamol (TYLENOL); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient was not pregnant at the time of vaccination. The patient experienced left arm pain day of vaccine lasting through the week from 23Dec2020 06:00. Headache everyday after. On 28Dec2020 the patient noted numbness/swelling to left side of face, some numbness and tingling intermittent left arm. Left neck stiffness and pain. On 31Dec2020 increased left neck pain 10/10 and noted drooping of right side of face at mouth, left ear and teeth pain. On 02Jan2021 face swelling including eyes, increase ear and teeth pain including left jaw. Headache and neck pain continued. On 05Jan2021 Virtual visit with NNP started AbX and steroids (possible bells palsy flair up) and dentist visit no issues with teeth. On 08Jan2021 neurology visit diagnosed with bells palsy reoccurrence related to vaccine. Throughout the week increased numbness, tingling, and pain to left arm. With intermittent sciatic type pain to left leg. her whole left side had felt different since the vaccine. Constant left arm numbness, tingling, and pain since 09Jan2021. Minimal relief from headaches pain from 8 to 5. On 13Jan2021 10/10 left arm pain, sharp, stabbing, weak, painful to move. Treatment Steroids, pain meds, and MRI scheduled were received. All events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event headache was recovering, the outcome of the other events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association, the facial paralysis recurrence is possibly related to suspect BNT162b2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-01-25 lymph node pain, lymph node swelling Chills, nausea, fever, sweats x 24 - 48 hours; headache, fatigue, painful swollen lymph nodes (left ... Read more
Chills, nausea, fever, sweats x 24 - 48 hours; headache, fatigue, painful swollen lymph nodes (left posterior cervical) x 72 hours
42 2021-01-25 peripheral swelling Itchiness throughout body, swollen shots on wrists and under feet, tiny dots on arms Now resolved
42 2021-01-26 anaphylactic reaction Systemic: Anaphylaxis-Severe
42 2021-01-29 peripheral swelling 45 minutes after given the vaccine. Severe dizziness, stumbling, couldn't see straight, Had somewha... Read more
45 minutes after given the vaccine. Severe dizziness, stumbling, couldn't see straight, Had somewhat similar reaction to the first dose went down to the Emergency room on 12/31/20. They treated it as vertigo. gave zofran for nausea and valium to calm me down. Was sent home with Meclizine (motion sickness)meds. I am at 9 days after the vaccine administration and still having the vertigo and nausea due to being dizzy. I didn't go to the emergency room right away as I was treating it as they treated the first one. I fell asleep as soon as I got home from work at 130pm. I got the second dose at 0900 on 1/21/21. Fell asleep for several hours. Could barely wake up. Hands and feet were swollen. Couldn't make fists. Feet were tight. Stayed hydrated. since then for the past week I have been taking motion sickness meds the dizziness has not gone away. Went to the Emergency room on 1/28/21 as the symptoms still haven't gone away. They ruled me out for a stroke. I felt completely normal before the vaccine. I had CT scan done, MRI both came back normal. The diagnosis that was the outcome was vertigo.
42 2021-01-30 lymph node swelling, lymph node pain 1/29/21 4:26p received 2nd vaccine 8:10p became extremely tired 1/30/21 awoke t... Read more
1/29/21 4:26p received 2nd vaccine 8:10p became extremely tired 1/30/21 awoke to low grade temp, pain, swelling, red injection site, headache; rest of the day tiredness, chills, muscle & joint pain, nausea. Taking Tylenol for pain 1/31/21 awoke to low grade temp, tiredness and enlarged right under arm lymph node, size of an egg, very sore, injection site remains red, tender to touch and swollen, taking Tylenol for pain As of 12:49p no temp
42 2021-01-30 swelling 12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area... Read more
12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area Jan. 2 & 3: didn?t sleep well Jan. 4: mental fatigued Jan. 7: fever 101.2F, shallow breathing, upper quadrant pain, rash on neck Jan. 8: rash on abdomen; right flank pain?spoke with her Endocrinologist who think reactions are auto-immune related Jan. 15: increased blood pressure?consulted a Cardiologist and was prescribed a medication Jan. 15: had labs drawn?IgG 69 Jan. 28: consulted with a Neurologist who think she may have acute encephalitis related to the vaccine and recommended not to get the 2nd dose
42 2021-01-31 lymph node pain, lymph node swelling, swelling Swollen, hard, painful lymph node on left side of neck. Left clavicle painful to touch and swollen.... Read more
Swollen, hard, painful lymph node on left side of neck. Left clavicle painful to touch and swollen. No redness at site or other symptoms noted.
42 2021-01-31 peripheral swelling Body aches, fever = 101.5, swelling in arm, soreness in arm
42 2021-02-01 lymph node swelling 13 hours after vaccine I woke with a fever around 103 with chills, body aches, joint pain, headache,... Read more
13 hours after vaccine I woke with a fever around 103 with chills, body aches, joint pain, headache, ear pain and upset stomach. All of Saturday these symptoms went on and I had a tightness in my throat, not pain. I was very delirious and speaking jibberish when awake. Sunday the fever lessened and I felt more alert, but a large swelling started in my armpit in the left arm. Monday the fever was gone but I still had major joint pain, off and on headache and overall sick feeling. Today I woke and have a very upset stomach and achy feeling all over. The lump in my arm pit has gotten smaller but is still painful and visible.
42 2021-02-01 peripheral swelling, swollen extremities Reported to me over the phone:The night of the vaccination the left arm became very painful and swol... Read more
Reported to me over the phone:The night of the vaccination the left arm became very painful and swollen. The next day the swelling continued into armpit, noticed chills from waist down and a decrease in ROM with weakness.
42 2021-02-02 lymph node swelling, lymph node pain 1/29/21 Friday night: Muscle in upper arm knotted up so bad it pinched the nerve and my arm was use... Read more
1/29/21 Friday night: Muscle in upper arm knotted up so bad it pinched the nerve and my arm was useless. I had muscle weakness and joint pain down to my wrist. I had to do old physical therapy exercises, ice pack on upper arm, and took tylenol (really wanted to take advil). Saturday evening: I discovered my lymph gland was swollen and very sore under my left arm. Took a hot shower and it helped. As long as I don't wear a regular bra it's ok. Sore to touch or if I moved my arm a lot. Tylenol (again with the advil)and heating pad. Still sore today. Creeps me out. I also, slept all day Saturday. Took a long nap Sunday. Went to the clinic on Monday, back to another clinic on Tuesday-Tuesday was when I had the extreme exhaustion. I napped for 3 hours in the afternoon and was so tired and woozy when I woke up. I had brain fog. Couldn't concentrate or care about much for awhile. Today, I slept in, and feel fineat the moment. Waiting to see if I have that nap exhaustion thing. I plan to walk some and go pick up some Vitamin C and Zinc supplements today.
42 2021-02-03 lymph node swelling Left axillary lymphadenopathy; This is a spontaneous report from a contactable physician (patient). ... Read more
Left axillary lymphadenopathy; This is a spontaneous report from a contactable physician (patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) solution for injection, via an unspecified route of administration on left arm on 16Jan2021 09:00 at a single dose for Covid-19 immunization. Medical history was reported as none. Patient has no known allergies. There were no concomitant medications. Patient was not pregnant. The patient received the first dose on 28Dec2020 (lot number: EK5730). Patient did not receive other vaccine in four weeks. Patient has no other medications in two weeks. The patient experienced left axillary lymphadenopathy on 17Jan2021 21:00. Patient did not receive any treatment. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not been tested for Covid-19 after vaccination. Outcome of the event was recovered. No follow-up activities are needed. No further information is expected.
42 2021-02-04 lymph node swelling Swollen lymph nodes; This is a spontaneous report from a Pfizer-sponsored program. A contactable con... Read more
Swollen lymph nodes; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient) reported a 42-years-old female patient started to receive the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1686 ) , via an unspecified route of administration on 19Jan2021 at SINGLE DOSE right Arm for covid-19 immunisation. The first dose bnt162b2 was received on 28Dec2020 for covid-19 immunisation. Medical history included severe allergies, hypothyroidism. There were no concomitant medications. The patient experienced swollen lymph nodes on 20Jan2021. The patient has done no treatment for the swollen lymph node, not even applying heat. The outcome of event was unknown.
42 2021-02-08 anaphylactic reaction anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous... Read more
anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous report from contactable pharmacists and an other hcp and a nurse. A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) intramuscularly on 25Jan2021 15:15 in right deltoid at single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. Concomitant medications included high blood pressure medication. Patient was not able to breathe or talk. Her throat was closing up. They had to use epinephrine to help her breath. It was reported as anaphylactic reaction. The vaccine was administered at 15:15, patient was interacting with HCPs who asked basic questions and at some point (15:17) patient was not responsive, patient was not able to breath and talk. All events started from 25Jan2021 15:17. Patient was administered Epipen (also reported as Benadryl and Epinephrine) and "she came back". Patient was taken to hospital. Patient refused to call an ambulance. She was taken to hospital. The patient was not seen in the Emergency Department. The patient was not admitted to an Intensive Care Unit. No other vaccine in four weeks. No covid prior vaccination. Unknown if covid tested post vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient has not received any other vaccines around the time of bnt162b2 vaccination. The patient underwent lab tests and procedures, which included heart rate with result of went up as soon as epipen was administered, O2 saturation and vitals with unknown results, all on 25Jan2021. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylactic reaction with throat closing up and being unable to breathe or talk. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-02-08 peripheral swelling After receiving dose one on Saturday Jan 30 2021 I was okay and a few days later about a week I noti... Read more
After receiving dose one on Saturday Jan 30 2021 I was okay and a few days later about a week I noticed swelling and redness on my left arm where the shot was administered. It itches really bad. I scratched it several times and then put rubbing alcohol on it to ease the itchiness. Currently my left arm is still red and swollen and itchy.
42 2021-02-11 lymph node swelling I started having increased pain under my left arm that increased to some chest discomfort, body ache... Read more
I started having increased pain under my left arm that increased to some chest discomfort, body aches, low-grade fever. When I woke up the morning of the 8th I had a swollen lymph node the size of a baseball under my left arm.
42 2021-02-11 lymph node swelling I experienced a ball size lymph node under my left arm which was very painful to touch. I also devel... Read more
I experienced a ball size lymph node under my left arm which was very painful to touch. I also developed chills and body aches.
42 2021-02-11 swelling, lymph node pain, lymph node swelling I experienced swelling and tenderness to my lymph nodes and left axilla after receiving my first dos... Read more
I experienced swelling and tenderness to my lymph nodes and left axilla after receiving my first dose injection. I experienced large swelling up my neck , left side radiating to my shoulder blade. I experience a large lymph node which was swollen and very painful touch.
42 2021-02-14 lymph node swelling Started my period five (5) days early - have a very regular cycle Swollen lymph nodes under left arm... Read more
Started my period five (5) days early - have a very regular cycle Swollen lymph nodes under left arm - arm vaccine was given in
42 2021-02-14 lymph node swelling developed diffuse tender adenopathy, weakness and fevers. Admitted with severe neutropenia - ANC 0.
42 2021-02-15 lymph node swelling Swollen lymph nodes on my left armpit and left clavicle.
42 2021-02-15 white blood cell count increased Diabetic ketoacidosis without coma associated with type 2 diabetes mellitus (CMS/HCC) (2/15/2021) PO... Read more
Diabetic ketoacidosis without coma associated with type 2 diabetes mellitus (CMS/HCC) (2/15/2021) POA: Yes Active Problems: Uncontrolled type 2 diabetes mellitus with hyperglycemia, with long-term current use of insulin (CMS/HCC) (5/6/2016) POA: Not Applicable Lactic acidosis (2/15/2021) POA: Yes Vaccination reaction - suspected (2/15/2021) POA: Yes Hyponatremia (2/15/2021) POA: Yes Was admitted to the ICU for further treatment
42 2021-02-16 lymph node swelling Woke up at 3:30am with severe chills and night sweats, could not get warm. Fever (101.7) started at ... Read more
Woke up at 3:30am with severe chills and night sweats, could not get warm. Fever (101.7) started at 8am 1/10 . took Acetaminophen 1000mg for fever, headache, body aches, and weakness in extremities , increased fluids. Noticed a swollen sub clavicular lymph node on the left side That grew to the size of an almond. Migraine started at 11am same day. Took PRN Maxalt for Migraine and slept the rest of the day. Next day (1/11) slight headache that waxed and waned the rest of the day. Fever of 100.1 by 2:30 that same afternoon. Took Acetaminophen and fever resolved by the next day. Was seen for lymph node a week later by PCP and sent for an ultrasound. On 2/5 was scheduled for biopsy but on Ultrasound the lymph node had decreased in size from 2cm to 1.5cm on its own. Decided to hold off. Lymph node is now normal in size
42 2021-02-18 lymph node swelling, lymph node pain Clammy hands/feet early 5am on 2/13/21, went to ER 2/13/21 due to numbness on R side of face with... Read more
Clammy hands/feet early 5am on 2/13/21, went to ER 2/13/21 due to numbness on R side of face with tingling on R side of head and tightness of neck. 2/14 thrush in mouth 2/15 - achiness L arm 2/16- pain swollen lymph r side, clammy hands persist with foul smell Ongoing tingling in my Whole Back, Fluctuating BP , tachycardia
42 2021-02-18 lymph node swelling Immediately following the vaccination, I had some site pain. I felt tired that evening and went to b... Read more
Immediately following the vaccination, I had some site pain. I felt tired that evening and went to bed early, sleeping well (Wednesday night). Approximately 20 hours after receiving my 2nd vaccine (10am Thursday), I developed a low fever (99`), extreme lethargy, chills, and overall body aches. These symptoms lasted approximately 13 hours. When my fever broke (approximately midnight Thursday), the body aches and chills went away as well. The next day (Friday), I woke up to significant arm pain, severe headache, tingles in my arm, swollen lymph nodes in my arm pit and neck, as well as a rash on my upper arm around the injection site. These symptoms persisted until Sunday. The rash and swollen lymph nodes disappeared Sunday night/Monday morning. Since Monday, however, the headaches, arm pain, and some tingles in my arm have persisted all week. Motrin curbs the pain of the headaches and arm pain, but as it wears off the pain resurfaces.
42 2021-02-18 lymph node swelling could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; ... Read more
could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself. This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.
42 2021-02-18 swollen extremities, lymph node swelling, lymph node pain About 3 hours after the afternoon shot, I noticed I began to feel bad. Not in any specific way, just... Read more
About 3 hours after the afternoon shot, I noticed I began to feel bad. Not in any specific way, just bad. That evening, I noticed chills, pressure at the top of my head, sensitivity to sounds, and aching body. That night, I had trouble sleeping due to all of this. The next day, an additional thing I noticed was how much my lymph nodes hurt, especially in the throat and armpits. The left armpit in particular was more swollen and painful than at any other time in my life. I could not put my arm down without pain. The day after that, the feelings subsided. This 3rd day after the shot, my left armpit lymph node is a little sore, but I am able to do my daily activities. I took children's chewable aspirin tablets the first evening, day and 2nd evening.
42 2021-02-19 lymph node swelling For 3+ days post injection: Significant lymph node swelling in left armpit, severe swelling and redn... Read more
For 3+ days post injection: Significant lymph node swelling in left armpit, severe swelling and redness at injection site ( walnut sized), 1 day only post injection: mild fever, chills, muscle and joint pain, fatigue
42 2021-02-19 lymph node swelling Lymph node swelling in left armpit, fatigue, injection site pain, redness and swelling
42 2021-02-20 lymph node swelling Swollen lymph nodes, underarm righ side
42 2021-02-23 anaphylactic reaction anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue... Read more
anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue tingled; sore/scratchy throat; metal taste in mouth; shakiness (like internal vibration); This is a spontaneous report from a contactable other hcp. A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 03Feb2021 08:00 for covid-19 immunisation. Medical history included depression, anxiety, drug hypersensitivity to codeine, sulfa meds, influenza vaccine, food allergy to quinoa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), probiotics. The patient experienced anaphylactic reaction on 03Feb2021 08:30, flush face with itching on 03Feb2021 08:30, throat became itchy on 03Feb2021 08:30, tongue tingled on 03Feb2021 08:30, sore/scratchy throat on 03Feb2021 08:30, metal taste in mouth on 03Feb2021 08:30, shakiness (like internal vibration) on 03Feb2021 08:30. Patient went to Emergency Room and was treated with Benadryl, Pepcid C, Decadron, Epi. The outcome of the events was not recovered. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information, a possible contribution of the drug to the event anaphylactic reaction cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-02-23 swelling face Pt was waiting in parking lot after receiving injection. Notified attendant that she was experienci... Read more
Pt was waiting in parking lot after receiving injection. Notified attendant that she was experiencing sensation of right facial "fullness" . RN's x 2 arrived at pt's car to assess and monitor. Denied shortness of breath or any other adverse symptoms. Vital signs taken - see below. Pt reported to RN that she had "forgotten to report" alleric response to shellfish. Benadryl 25 mg administered po and RN continued to monitor. Pr reported no further progression of swelling and was allowed to leave lot after 20 minutes. Stated she was going to her grandmother's house and would take another 25 mg of Benadryl on arrival there. RN instructed to seek medical attention immediately (ED or call 911) if sx progress.
42 2021-02-23 swelling face per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that... Read more
per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that after her second dose she experienced facial swelling, hives, chest pain , joint pain and feels tingling in her body
42 2021-02-24 peripheral swelling Chills, headache and Fever 100.4 at 9pm on 2/23/2021. Sore arm. Swelling below injection site 2/24/2... Read more
Chills, headache and Fever 100.4 at 9pm on 2/23/2021. Sore arm. Swelling below injection site 2/24/2021. Swelling is spreading further down the arm 2/25/2021.
42 2021-02-26 lymph node swelling I had the injection at 1000 am. At 8pm, I had chills, fever (Tmax 101), body aches, bone pain, fatig... Read more
I had the injection at 1000 am. At 8pm, I had chills, fever (Tmax 101), body aches, bone pain, fatigue, and swollen lymph node under my right arm. For about 4 hours, I could barely move because I was in so much pain. These symptoms continued, but after the four hours, was a little better. I still had significant symptoms for another day and a half. The symptoms slowly decreased until gone. I was off of work for 3 days. No treatment outside of OTC Tylenol, Aleve, ice pack, and rest.
42 2021-02-26 swelling face Throat itching, hoarse voice, nasal stuffiness, facial swelling (subjective), chest tightness Treatm... Read more
Throat itching, hoarse voice, nasal stuffiness, facial swelling (subjective), chest tightness Treatment - self treated with Benadryl (75mg), Zyrtec 10mg. Mild improvement 2 hours later, s/s not completely resolved at time of submission
42 2021-02-28 lymph node swelling Patient has a history of Hodgkins Lymphoma with radiation to mediastinum/chest (2012) and high risk ... Read more
Patient has a history of Hodgkins Lymphoma with radiation to mediastinum/chest (2012) and high risk for breast cancer. Found to have asymptomatic left axillary lymphadenopathy on screening mammogram and subsequent US.
42 2021-03-01 peripheral swelling Received vaccine 1/07/2021. 1/08/2021 had soreness to the injection site and the soreness continues... Read more
Received vaccine 1/07/2021. 1/08/2021 had soreness to the injection site and the soreness continues Numbness then developed 5 days later on 1/12/2021. Numbness starts at the infection site and runs down the arm and numbness extends to the left thumb and part of the left index finger. 1/18 Left thumb ridge started. 1/19/2021 PCP advised take naproxen 500 twice a day, vitamin B12, EKG unremarkable; 1/28/2021 reported to ED 5:00am as began experiencing numbness sensation on the bottom aspect of her face, bilaterally about 4 hours ago while working. Still having persistent numbness in left arm. Arm swelling. CT unremarkable; 1/29/2021 Neurologist believes related to the vaccine and order EMG, treating conservatively; 2/17/2021 had EMG that was unremarkable
42 2021-03-02 lymph node swelling tingling in vaccine arm grey tinge to hand on vaccine arm fatigue pain across shoulders pain down bo... Read more
tingling in vaccine arm grey tinge to hand on vaccine arm fatigue pain across shoulders pain down both sides of spine - Severe pain to adjust head on pillow or shift in bed even the slightest bit felt no need to blink for a few hours slept from 8pm Saturday until 10am Monday - Sleep was the only way to avoid the pain Alleve didn't touch the pain Tylenol began to help after 24 hours low fever around 100.4 skin was super-sensitive to touch swollen lymph nodes in neck on vaccine side swollen lymph nodes under arm on vaccine side - baseball-sized and painful to the touch
42 2021-03-03 lymph node swelling, lymph node pain Swollen lymph nodes on right breast near armpit. Sore. Tender. Has been there for a couple of days s... Read more
Swollen lymph nodes on right breast near armpit. Sore. Tender. Has been there for a couple of days so far.
42 2021-03-04 lymph node swelling Woke with fever 102.5, shivering had body aches swollen glands in throat weakness dizzy for 24 hours... Read more
Woke with fever 102.5, shivering had body aches swollen glands in throat weakness dizzy for 24 hours. Then weak following 24 hours. 5days after had menstrual period start even though had just ended prior 2 days prior.
42 2021-03-04 lymph node swelling Elevated temperature (100.2), body aches, chills, sore arm, extremely swollen auxiliary lymph nodes ... Read more
Elevated temperature (100.2), body aches, chills, sore arm, extremely swollen auxiliary lymph nodes on left side. All symptoms began about 24hrs post vaccine. Swollen lymph nodes and near breast , below armpit stayed very sore and swollen for 5 days. All other symptoms were gone after about 24 hrs (48hrs post vaccine). Treated with ice, cool compress, probiotic, ibuprofen.
42 2021-03-04 lymph node swelling Swelling and discomfort in left underarm lymph node, fever, body aches
42 2021-03-05 guillain-barre syndrome Guillain-Barre-Landry Syndrome (AIDP). Presented with paresthesia's, loss of Deep Tendon Reflexes, a... Read more
Guillain-Barre-Landry Syndrome (AIDP). Presented with paresthesia's, loss of Deep Tendon Reflexes, and proximal > distal LE weakness. Placed on IVIG on 3/4/2021 with improved symptoms of LE weakness but noted residual abnormal sensation
42 2021-03-10 lymph node pain Pain in areas where lymph nodes exist- arm pits, groin, malaise, aches in joints, and nausea.
42 2021-03-10 lymph node swelling, swelling Inflammation of nodes, bump on the left axilla with pain.
42 2021-03-11 lymph node swelling Fever >102; chills; dizziness - lasted 6 hours loss of consciousness - passed out about 2AM for just... Read more
Fever >102; chills; dizziness - lasted 6 hours loss of consciousness - passed out about 2AM for just about 30 seconds swollen lymph node under right arm - persisting on day 3 post injection brain fog - lasted 2 days
42 2021-03-14 lymph node pain significant pain in right armpit lymph node area; Severe nerve pain throughout right upper quadrant ... Read more
significant pain in right armpit lymph node area; Severe nerve pain throughout right upper quadrant of my body, in arm and back (spine); Pain similar to pinched nerves, with pain, tingling; Pain similar to pinched nerves, with pain, tingling; Pain similar to pinched nerves, with pain, tingling; occasional heat sensation; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female non-pregnant patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), via an unspecified route of administration on 26Feb2021 17:30 at single dose in Right arm for COVID-19 immunisation. There was no medical history, no Allergies to medications, food, or other. Concomitant medication included metformin, fish oil, colecalciferol (D3) within 2 weeks of vaccination. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) at the age of 42-year-old, on 29Jan2021 17:30 at single dose in Left arm for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe nerve pain throughout right upper quadrant of her body, in arm and back (spine), began the afternoon the day after the second shot on 27Feb2021 03:00 PM and progressed throughout the day, until almost unbearable that evening, even with 800mg ibuprofen. Pain was similar to pinched nerves, with pain, tingling, occasional heat sensation, as opposed to that of a pulled or sore muscle. The patient could not lay in bed that evening and had to sleep upright in a chair with a pillow under her elbow to get minor relief. This pain continued on day 3, but was starting to lessen slightly. Day 2 (28Feb2021), the patient also developed significant pain in right armpit lymph node area, becoming more intense on day 3. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of "severe nerve pain throughout right upper quadrant of my body, in arm and back (spine)", "pain similar to pinched nerves, with pain, tingling" which included 800mg ibuprofen. There was no treatment received for the remaining events. The outcome of the events was unknown. The events were reported as non-serious.
42 2021-03-14 peripheral swelling Swollen bottom lip Major swelling more than my normal in my legs and hard to move knees Around injec... Read more
Swollen bottom lip Major swelling more than my normal in my legs and hard to move knees Around injection site big red area showed up about 2 weeks after 1st dose
42 2021-03-15 lymph node swelling Received mammogram on 3/1/21 that came back as abnormal on right side. Repeated mammogram and got ul... Read more
Received mammogram on 3/1/21 that came back as abnormal on right side. Repeated mammogram and got ultrasound on 3/12/21 that confirmed enlarged right lymph nodes. I was told it was most likely due to the Covid-19 vaccine being administered on that side, and that I needed to return in three months for follow up imaging.
42 2021-03-15 swelling face WITH IN THE FIRST 15 MINUTES I EXPERIENCED DIZZINESS. WITHIN THE FIRST HOUR MY EYE BROWS SWELLED AND... Read more
WITH IN THE FIRST 15 MINUTES I EXPERIENCED DIZZINESS. WITHIN THE FIRST HOUR MY EYE BROWS SWELLED AND I HAD A RIGHT SIDED FRONTAL HEADACHE. I TREATED WITH ICE PACK, TYLENOL, AND CLAIRITIN. 2 HOURS LATER I FELT LIKE I WAS AT HIGH ALTITUDE WHICH LASTED FOR 36-48 HOURS. tHE SWELLING BROKE DURING THE NIGHT WITH MASSIVE EYE TEARING AND POST NASAL DRIP. I CRAVED BLACK LIC0RICE LIKE MAD.
42 2021-03-15 swelling Immediate large local reaction, 4" area induration/erythema/swelling/tenderness/warmth, no systemic ... Read more
Immediate large local reaction, 4" area induration/erythema/swelling/tenderness/warmth, no systemic sx
42 2021-03-17 lymph node pain Burning sensation up neck and head after vaccine; severe pain in left arm in underarm area; fatigue
42 2021-03-17 lymph node swelling After I received the 2nd vaccine I experienced chills and fatigue for two days. 2 weeks after the 2n... Read more
After I received the 2nd vaccine I experienced chills and fatigue for two days. 2 weeks after the 2nd dose I got a rash of tiny bumps starting around my neck and then spread across my entire body including my scalp. I had inflamed lymph nodes and a cyst near the lymph node was inflamed. The rash continued. I went to my family dr and she gave me 4 days of 20mg prednisone. That helped some. After I finished the medication the rash was healing and then I started having hives that covered my entire body. I am also having 'hotspots' that flare up daily. I have had at least 25 hotspots. my skin stays severely dry no matter what I try. I went back to the dr when the hives started and she gave me a heavy taper down series of prednisone. while it has helped some my body still has hotpots, under the skin is prickly, tingly, and my skin acts like it has been sunburned is is peeling off. I have sores and raw spots randomly over my body. I am also using benadryl to help.
42 2021-03-18 anaphylactic reaction Patient was determined to have an anaphylactic reaction by MD's on site. Benadryl was administered, ... Read more
Patient was determined to have an anaphylactic reaction by MD's on site. Benadryl was administered, followed by Epinephrine 10minutes after Benadryl. EMS was called at that time and patient was transferred to higher level of care via ambulance.
42 2021-03-18 lymph node swelling, lymph node pain Tiredness (1 week), muscle aches (48 hours) torso numbness in the skin (ongoing), itchy torso (ongoi... Read more
Tiredness (1 week), muscle aches (48 hours) torso numbness in the skin (ongoing), itchy torso (ongoing), swollen and sore lymph nodes under left arm (ongoing), large bump on back (ongoing)
42 2021-03-18 lymph node swelling Nasuea, Fever, chills, headache, body aches, swollen lymph node, arm pain for 24 hours that began 14... Read more
Nasuea, Fever, chills, headache, body aches, swollen lymph node, arm pain for 24 hours that began 14 hours after shot continual runny nose since shot, ongoing chills since shot, sore nostril,
42 2021-03-19 peripheral swelling Patient had calf swelling and then more after Covid Vaccine. Patient then had SOB. Patients primary ... Read more
Patient had calf swelling and then more after Covid Vaccine. Patient then had SOB. Patients primary obtained dopplers and CT chest, which showed DVT's and PE. Patient had shoulder surgery 3 months ago, is more sedentary than had been.
42 2021-03-21 lymph node swelling, lymph node pain lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, ... Read more
lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, it was difficult to put my arm down; feeling bad in a non-descript way; sensitive to sounds; feeling pressure in my head at the top third of it; chills; body aches; Couldn't sleep due to discomfort; discomfort; This is a spontaneous report from a contactable healthcare professional (patient). This 42-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unspecified route of administration on 16Feb2021 at 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included endometriosis, depression, anxiety, thoracic scoliosis, and a herniated disc at L4-L5. The patient was not pregnant at the time of vaccination. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included bupropion, citalopram, and tramadol from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EL9261) on 28Jan2021 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 16Feb2021 at 17:00, a few hours after the vaccine the patient noticed feeling bad in a non-descript way. Soon after in the evening she was sensitive to sounds, felt pressure at the top third of her head, chills, and body aches. She could not sleep that evening due to discomfort. On 17Feb2021 lymph nodes hurt extremely especially In the throat and arm pits. The patient's left armpit node was so swollen and painful it was difficult to put her arm down. The second day the symptoms were the same but lessened. The third day only the left armpit node hurt a little. The events were reported as non-serious. The patient was not hospitalized for the events. The patient received treatment with children's chewable aspirin in the evening of 16Feb2021 and the day and evening of 17Feb2021. The outcomes of feeling bad in a non-descript way, sensitive to sounds, pressure at the top third of the head, chills, body aches, couldn't sleep due to discomfort, lymph nodes hurt, and left armpit node swollen and painful were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
42 2021-03-21 lymph node swelling Pt reports "I was extremely weak, fatigued, high fever, swollen lymph nodes in my left arm pit and e... Read more
Pt reports "I was extremely weak, fatigued, high fever, swollen lymph nodes in my left arm pit and elbow. my right arm (injection site) is red, swollen, tender and warm to touch"
42 2021-03-22 anaphylactic reaction Patient received dose at a clinic provided by store pharmacy at 9:30 AM on 2-25-2021. Patient stated... Read more
Patient received dose at a clinic provided by store pharmacy at 9:30 AM on 2-25-2021. Patient stated she started to have anaphylactic reaction to the Pfizer -Biotech COVID vaccine around 7:00 PM that same day. Her eyes swelled up and her throat started to feel like it was closes so she went to the ED at Hospital. At the hospital, she received an Epipen and a shot of benadryl. The reaction was taken care of and she was able to return home later that night with no lingering effect of the reaction.
42 2021-03-22 neck mass, swelling face 90 minutes after vaccine administration, patient developed hives over neck and face and severe itchi... Read more
90 minutes after vaccine administration, patient developed hives over neck and face and severe itching on face, neck, and scalp, as well as a significant lump on the right side of neck; the following morning, severe facial swelling in cheeks and around eyes that made it difficult to open eyes; facial swelling and itching has improved but is still present (as of today, 3/23/21, four days after vaccine); lump on neck is still present but is smaller; patient has been taking Zyrtec, Benadryl, Tylenol, and topical cortisone cream.
42 2021-03-23 lymph node swelling swollen lymph nodes; Injection site pain; muscle pain/body aches; feeling unwell; This is a spontane... Read more
swollen lymph nodes; Injection site pain; muscle pain/body aches; feeling unwell; This is a spontaneous report from a contactable Other Health Professional. A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6201), intramuscularly, on 20Feb2021 at 12:00 (at the age of 42-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included obesity, eustachian tube dysfunction. The patient is allergic to grass (fescue). Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318), intramuscularly, on 30Jan2021 at 12:00, intramuscularly in the right arm. The patient was not pregnant at the time of vaccination. The vaccine was administered at a workplace clinic. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were reported as "None." The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Feb2021 at 15:00 the patient experienced Injection site pain, muscle pain/body aches, feeling unwell, swollen lymph nodes. The patient did not receive any treatment for the events. The clinical outcomes of the events vaccination site pain, muscle pain/body aches, feeling unwell, swollen lymph nodes were reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
42 2021-03-24 lymph node swelling 1) Sore arm at injection site. 2) Very swollen lymph nodes under arm. -took ibuprofen and used an i... Read more
1) Sore arm at injection site. 2) Very swollen lymph nodes under arm. -took ibuprofen and used an ice pack for the lymph nodes.
42 2021-03-24 peripheral swelling Left upper arm, arm pit, left upper quadrant swelling. Left Breast increased to twice normal size. ... Read more
Left upper arm, arm pit, left upper quadrant swelling. Left Breast increased to twice normal size. Swelling continued for 4 days and slowly subsided.
42 2021-03-25 lymph node swelling Arthritic inflammation, headache, visibly swollen lymph nodes under right arm
42 2021-03-25 lymph node swelling Hard lump behind left ear (same side as injection site)
42 2021-03-26 lymph node swelling Swollen lymph nodes - left collarbone Back ache Tiredness
42 2021-03-26 swelling face In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (s... Read more
In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (spoke broken English Asian decent) brought to recovery area in wheelchair to lie down supine Assess: - LOC, -SOB, - N/V, slight pale - Rash. - facial swelling, - tongue swelling. stated she was anxious to get vaccine Left Deltoid site benign, VS 130/72, HR 95 reg strong, resp 12 reg non labored. Medical called to evaluate. Encouraged hydration, Provided reassurance monitored 1 hr (per pt request) No further symptoms developed. Advised if anything occurs later in day call 911 if life threatening or go to urgent care. sign to V-safe . Ok'd to exit 9:45 am
42 2021-03-27 lymph node swelling ?Pfizer-BioNTech COVID-19 Vaccine EUA? Pain started 4 days after, just above and the the right of g... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA? Pain started 4 days after, just above and the the right of gential area, groin. 8 days later I had a swollen and painful lymphnode and red bumps appeared nearby and on my back. On day 9 a doctor diagnosed it as Shingles. The pain continues to increase.
42 2021-03-27 peripheral swelling Patient came to our clinic today because she is concerned with a rash on left left Deltoid appearing... Read more
Patient came to our clinic today because she is concerned with a rash on left left Deltoid appearing one day after she got vaccinated at pharmacy. She has swelling, redness, and pain on the affected site. She was advised to take Benadryl, avoid scratching area. She can also apply cortisone cream instead of scratching area. She was told to monitor and report any symptoms that occur.
42 2021-03-28 swelling Upon injection, I felt a sharp pain, not the same as I had felt with my previous injection. Later on... Read more
Upon injection, I felt a sharp pain, not the same as I had felt with my previous injection. Later on the morning, I saw that the clear bandaid had some blood on it. Later on, I noticed that the bandaid was coming off, when I removed it, it was filled with clear liquid. The amount was to the point that it soaked my bandaid that it was coming off. At this point, I do not know how much of the vaccine was injected in me or how much of it leaked out. Symptoms post vaccination: soreness and a large bump, injection site is red, warm, and pain to touch.
42 2021-03-29 peripheral swelling Swelling of 2nd and 3rd digits of both feet. There was reddish bluish discoloration of the toes. Thi... Read more
Swelling of 2nd and 3rd digits of both feet. There was reddish bluish discoloration of the toes. This was sudden in onset without any trauma. Pulses were intact in both feet. Due to the swelling there was tenderness on the balls of the toes and it was painful to touch. Motrin 200 mg as needed helped relieve it for 1-2 days and then it would recur. The symptoms were present for 6 weeks and thereafter resolved.
42 2021-03-30 lymph node swelling I have what appears to swollen lymph nodes in the collarbone, IT appeared on 03/08/2021, the day aft... Read more
I have what appears to swollen lymph nodes in the collarbone, IT appeared on 03/08/2021, the day after the first shot/injection, and has been swollen to the touch, a sore and irritated sensation at times. It is the size of an almond, and has not gotten any better.
42 2021-03-30 swelling Within minutes of receiving the vaccine, I felt tingling in my left arm at the shot injection site. ... Read more
Within minutes of receiving the vaccine, I felt tingling in my left arm at the shot injection site. About 20 mins later, I felt tingling and numbness in my upper lip as well as just above my lip. Consulted with the pharmacist who administered the shot as well as an on-line nurse about adverse side effect. I was instructed to take Benedryl, which I did (37.5 mg). It didn?t do anything to address the tingling. It has been four plus days since the vaccination and the right side of my upper lip feels swollen.
42 2021-03-31 peripheral swelling This may be within the normal bounds but wanted to make sure that I reported this as continued resea... Read more
This may be within the normal bounds but wanted to make sure that I reported this as continued research is ongoing with the Covid-19 vaccines. I received the Pfizer vaccine 2nd dose on March 29 around 12:15 pm. At the injection site I developed a light bumpy rash. My upper arm also was swollen -- the best way to describe the feeling is as if someone stitched a small ball into my skin and took a bat to it. Made it very difficult to work (typing), and lifting/using arm. I also had a mild sore throat for 48 hours post vaccination.
42 2021-04-01 lymph node swelling Large swollen lump on left quad in the pm on 4/1. Chills, fever, body aches, headache at 4am on 4/2 ... Read more
Large swollen lump on left quad in the pm on 4/1. Chills, fever, body aches, headache at 4am on 4/2 and onward through the day.
42 2021-04-01 peripheral swelling Patient reported feeling hot, nauseated, heart palpitations, tingling around lips and discomfort and... Read more
Patient reported feeling hot, nauseated, heart palpitations, tingling around lips and discomfort and tingling/numbness/discomfort in left arm within 5 minutes after injection in left arm. (She was negative for lip or oral mucosa swelling, voice change, SOB, rash, visible flushing, urticaria) Her vitals remained stable and initial sx resolved spontaneously within 15-120 minutes apart from swelling (without erythema or induration) and tenderness on left medial anticube, which was treated with ice. Patient had normal ROM, strength of left arm. Patient was observed or 50 minutes and cleared by NP and MD to leave with instructions to FU with ED if return of symptoms. Arm swelling was resolving when called the next day.
42 2021-04-01 peripheral swelling Vomiting, swelling of left hand, nausea. BP 118/81 (pulse 82), O2 sat 100%.
42 2021-04-03 swelling face i felt like i was passing out; i felt like i was dying; sweating on the drive home/sweating profusel... Read more
i felt like i was passing out; i felt like i was dying; sweating on the drive home/sweating profusely; a bout of diarrhea; nauseated; my ears started ringing really loudly, then hissing; could barely stand; my limbs started feeling cold; very thirsty; My pulse felt fast; shaky; My lips and face felt slightly swollen; My lips and face felt slightly swollen; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 42-years-old via an unspecified route of administration, administered in arm right on 18Mar2021 16:15 (Batch/Lot Number: Ep6955) as single dose for covid-19 immunisation. Medical history included known allergies: Sulfur dioxide preservative and almost died from blood loss from an unknown date and unknown if ongoing. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and venlafaxine hydrochloride (EFFEXOR XR); both taken for an unspecified indication, start and stop date were not reported. The patient reported that right after she left the waiting room, 15mins following the shot, she noticed she was sweating on the drive home, but felt normal, not expecting a problem. Then she felt terrible really fast. She had a bout of diarrhea, was nauseated and her ears started ringing really loudly, then hissing and she felt like she was passing out. She was sweating profusely and could barely stand. She laid down and her limbs started feeling cold and she got very thirsty. Her pulse felt fast it reminded her of when she almost died from blood loss. She felt like she was dying. The feeling lasted about 10 mins, then slowly started fading. She was shaky for the next hour. Her lips and face felt slightly swollen, but there was no itchiness or tightness in her throat. Her temperature was 96.0. She took a nap and woke up feeling better but my ears are still ringing. It has been about 2 1/2 hours. The events occurred on 18Mar2021 16:45. No treatment was received in response to the events. The patient was recovering from the events.
42 2021-04-07 swollen extremities Awakened with throbbing pain in the entire left arm (shoulder to fingertips). Numbness/tingling in l... Read more
Awakened with throbbing pain in the entire left arm (shoulder to fingertips). Numbness/tingling in left ring and pinky finger. Tenderness/swelling in the left armpit. Aching arm followed for a few days, but axillary swelling persisted for about 10 days. Occasional tingling in fingers is still present 2 weeks later.
42 2021-04-07 peripheral swelling After receiving the vaccine yesterday, I started filling amped up like a took a bunch of caffeine pi... Read more
After receiving the vaccine yesterday, I started filling amped up like a took a bunch of caffeine pills but I also had heavy eyes. Very dry mouth. Today I?m in pain from my neck to my hand. My entire arm feels swollen and burning. My hand is swollen and my finger tips are tingly. The severity of this pain started about 4 hours ago.
42 2021-04-07 swelling, peripheral swelling, swollen extremities Date and time adverse event started: From 1st dose ADE started same day (3/10/2021) at unknown time.... Read more
Date and time adverse event started: From 1st dose ADE started same day (3/10/2021) at unknown time. From 2nd dose ADE started (4/2/2021) approx. 8:30pm Adverse events experienced and are they still occurring now: From 1st dose: patient reported that on same day vaccine was administered (3/10/2021) she had some pain in her left arm so she took Motrin one time same day. The next day (3/11/2021) her left elbow and arm were swollen, sore, painful and she had muscle hardness, patient reported those symptoms subsided 6 days later without taking or applying any treatment. From 2nd dose: approx. a few minutes from rcvding the vaccine on (3/31/2021) she had experienced headache and dizziness, which she reported went away before leaving the vaccine administration site. Then on (4/2/2021 approx. 8:30pm), patient reported that the entire right side of her body from the foot, ankle, leg, armpit, shoulder areas there's burning sensations, and swelling. The left calf is also swollen and hard to the touch. Right arm red rash developed, hot to the touch, swollen, painful and burning sensation. Her left knee gotten red. Stomach pain/cramps. From last night until today, mild headache to right side of her head. What happened as a result of the adverse event? Patient reported for 1st vaccination ADE, she took Motrin one time on 3/10/2021. For her 2nd vaccination ADE, she took only 2 tablets of Bendaryl on 4/2/2021, and stated her swelling went down a little this morning when she woke up. She also reported that the right arm rash, swelling, pain and burning sensation subsided and that the redness on her left knee also went away. As of 4/3/2021, patient reported that her right leg, armpit and shoulder is still swollen, existing burning sensations, still extremely red, hot and hard to the touch. She reported she felt like her pain is not getting better. ***NOTE*** Recommended patient to go to urgent care or the hospital to get her symptoms check out as soon as possible since she stated that her pain and swelling is not getting better on the right leg, armpit, and shoulder.
42 2021-04-08 lymph node swelling axillary adenopathy on same side as vaccination, tender
42 2021-04-08 peripheral swelling Inner thighs to calf swollen, red, itchy. Looks like hives, large rash. Had a procedure in November... Read more
Inner thighs to calf swollen, red, itchy. Looks like hives, large rash. Had a procedure in November, Venaseal performed by a vascular doctor. Rash is along the vessels that were treated. Reaction 11pm same day, took Benadryl. Rash appears in afternoon and again in evening. I have photos.
42 2021-04-09 lymph node swelling, lymph node pain My arm was very sore almost immediately after injection. the next day my arm pit and left breast and... Read more
My arm was very sore almost immediately after injection. the next day my arm pit and left breast and area under left arm on body- were very swollen and sore. Maybe its the lymph nodes? I couldn't lift my arm. 10 days later and feels better but still have swelling and pain, lessens every day
42 2021-04-09 swelling face Vaccine given at 1039. At 1051, pt complained of increased facial swelling, redness, and throat itc... Read more
Vaccine given at 1039. At 1051, pt complained of increased facial swelling, redness, and throat itching. Rapid response called. Pt evaluated- O2 95% room air., resp rate 24, HR 136, and BP 148/104. Per pt, she has multiple allergies and this happens often. Her blood pressure is always elevated like this. Her face was swollen already as she was evaluated in the ER and monitored in the hospital overnight on 4/9/21. Pt able to hold a conversation without difficulty. Liquid Benadryl (25mg) given by mouth as pt denied any swallowing difficulties. EpiPen ready for administration. in the meantime, rapid response team arrived and transferred patient immediately to ER. RN had EpiPen with her to give if needed.
42 2021-04-09 swelling face -Recieved shot about 3pm -During the 15 min waiting period my eyes felt kind of dry and "weird". I ... Read more
-Recieved shot about 3pm -During the 15 min waiting period my eyes felt kind of dry and "weird". I honestly didn't even consider it could be a reaction, I thought the way I was breathing through my mask must have been drying my eyes out. -Left clinic after 15 mins, only symptom at this point was dry eyes -about 5 mins in to our drive home my face was feeling very funny and kind of numb. I was feeling worse and worse. -looked in mirror and noticed face was bright red and swelling up. Also my throat was fire red. -it was getting worse and worse, also was starting to get itchy. -My entire face was bright red -Stopped at Sister-in-law's house (cause it was on the way home and she is a nurse) and took two benadryl. Was observed for another 20 mins there and the reaction started to calm down. The redness was still there, but the swelling seemed to have stopped. -went home and kept a close eye on it the rest of the night. -became itchy, but no rash. The bright redness went away after about 20 mins, but my face stayed red (like a sunburn) most of the evening. Throat was red as well. -felt fine when waking up on 4/9 and no other instances of these symptoms -sore arm 4/8-4/10
42 2021-04-09 swelling face facial swelling; fever; body aches; chills; Rash on the neck spreading to head/rash on ears; This is... Read more
facial swelling; fever; body aches; chills; Rash on the neck spreading to head/rash on ears; This is a spontaneous report from a contactable other HCP (Patient). A 42-years-old non-pregnant female patient received second dose BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EL3302) via an unspecified route of administration, administered in Arm Left on 03Feb2021 as SINGLE DOSE for covid-19 immunisation. Historical vaccination first dose of BNT162B2 (Lot number: EL3302) via an unspecified route of administration in Arm Left on 13Jan2021 10:00 for covid-19 immunisation. Patient medical history reported none. Known allergies: IV ANCEF [cefazolin sodium]. The patient concomitant medications included multivitamins. On 13Feb2021 19:00 (after 10 days following 2nd dose) the patient experienced rash on the neck spreading to head and facial swelling, fever, body aches and chills and rash on ears. Patient received treatment as Prednisone, H2 Blockers and Antihistamine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No covid tested post vaccination. The outcome of the event was not recovered.
42 2021-04-10 swollen extremities, swelling face Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Fa... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: bilateral lower leg edema-Mild, Additional Details: Hx of asthma, previously diagnosed with COVID > 2 weeks ago, pt complained of bilateral lower leg edema 12 minuts after vaccine was given, pt given benadryl, 3 minutes later complained of throat tightening and tongue swelling, pharmacist administered epinephrine and called 911, EMS evaluated but pt refused transport
42 2021-04-10 swelling face I was find after the 15 minute waiting period. By the time I had pulled out of the complex in my ca... Read more
I was find after the 15 minute waiting period. By the time I had pulled out of the complex in my car my cheeks were bright red and it continued down my neck. My right side of neck felt tight/stiff. By the time I got home I had a hive above the right clavicle. Right hand felt numb. Heart rate accelerated, face became puffy. Lips and gums felt numb, throat got red and swollen, hive on right gum and back of throat felt itchy. Never lost ability to breath or swallow. High anxiety, felt extremely uncomfortable in my body. Took Histaminum hydrochloricum via bioAllers Pollen Hayfever treatment several times between 6:30pm and 10pm. Took Skullcap via tea between 7pm and 8pm. Reaction started to calm down around 8:45pm, and I felt back in my body by 10pm. It took until about 2:30am until my heart beat regulated. I will see a PCP hopefully today (Sunday) if not tomorrow.
42 2021-04-11 lymph node swelling Redness; swelling; large knot at injection site; swollen lymph nodes in armpit in injection; tinglin... Read more
Redness; swelling; large knot at injection site; swollen lymph nodes in armpit in injection; tingling down to fingertips of arm injected; shortness of breath and heart palpitations.
42 2021-04-12 lymph node swelling, lymph node pain Next day: mild chills, mild fever, strong headache (throbbing), by evening 2 lymph nodes near collar... Read more
Next day: mild chills, mild fever, strong headache (throbbing), by evening 2 lymph nodes near collarbone on left side (same as vaccine) were swollen and painful. The pain from the lymph nodes kept me awake some of next night. Minor pain and redness around injection site but similar to first dose. Following day: neck lymph nodes still very swollen but also one in the armpit region (also on left side) becomes swollen and painful so it became uncomfortable to use my left arm. Back pain and general pain around the rib cage (seemed to be muscular). The redness around the injection site grew larger (almost 10cm across); chills are gone, headache is gone, very mild fever a couple of instances during the day.
42 2021-04-12 lymph node swelling hives, rash, gums swelling and bleeding, oral ulcers, joint swelling hands and wrist swelling, nause... Read more
hives, rash, gums swelling and bleeding, oral ulcers, joint swelling hands and wrist swelling, nausea, fever chills, lymph node swelling
42 2021-04-12 peripheral swelling Very itchy and swollen rash inside both thighs. So far has lasted three days. Started nine days afte... Read more
Very itchy and swollen rash inside both thighs. So far has lasted three days. Started nine days after vaccine.
42 2021-04-14 lymph node swelling Enlarged lymph nodes near clavicle and neck
42 2021-04-15 lymph node pain, lymph node swelling Patient received the first shot of the COVID-19 Pfizer vaccine in the L arm on 4-6-21 at Hospital, a... Read more
Patient received the first shot of the COVID-19 Pfizer vaccine in the L arm on 4-6-21 at Hospital, and within 15 seconds reported a ?warmth? or ?burning? sensation in L arm, axilla, shoulder, chest, and stomach, and an almost immediate ?metallic taste? in her mouth. Shortly after she felt an increase in her heart rate. Approximately 30 minutes later she says she experienced nausea and like her ?tongue was swelling.? She went home and took a Benadryl and all symptoms had resolved within 30min-1hour. The following day (4-7-21), she was ?achey? and had low grade fever (Tmax 100.5F reported). That night (4-7-21), she felt like her axillary region was slightly sore or starting to swell, but woke up 4-8-21 to severe swelling, warmth , visible bruising, pain, tenderness, all in the L axillary region, so sought care at our office. She did have visible and palpable swelling under the L axilla, and it appeared her vaccine was given in the proper location and there was no local induration/warmth/tenderness at the injection site. She felt the same on 4-9-21, and by 4-12-21 all the axillary symptom had resolved and she only had sore lymph nodes under her jaw. By 4-14-21 all symptoms had resolved other than one small slightly tender lymph node under her jaw.
42 2021-04-15 lymph node pain 1 st Vax- within 15min throat lymph nodes hurt/throat hurts, achy, sore sensation & achy chest, not ... Read more
1 st Vax- within 15min throat lymph nodes hurt/throat hurts, achy, sore sensation & achy chest, not fully chest pains but an ache upper chest. Blood pressure 99/70ish 98%O2 heart beats a bit high. Checked out by nurses at clinic By 3:53pm left clinic in stable condition. Symptoms didn't worsen. A bit of chest tightness and start of coughs. Took benadryl. It helped ease symptoms in about an hr. 4:20pm redness in face hands and chest. Tired feverish muscle aches. Eyes tired By 5pm the chest discomfort disappeared. By 1am April 16th the pain in throat had dimished, but a low ache and a sore sensation still persisted until 9am approx.
42 2021-04-16 lymph node swelling Swollen breast tissue-full feeling with the feeling on more dense area of the breast tissue. Swollen... Read more
Swollen breast tissue-full feeling with the feeling on more dense area of the breast tissue. Swollen glands on left side in collarbone area same side that shot was given. Idiopathic Thrombocytopenia Purpura like symptoms-easy bruising, small red spots on feet, ankles, lower legs, waist area, and left wrist area.
42 2021-04-16 lymph node swelling Headache within 2 hours that lasted all day. 24 hours after shot - headache, fever, body aches fati... Read more
Headache within 2 hours that lasted all day. 24 hours after shot - headache, fever, body aches fatigue lasted 12 - 16 hours. This morning (22 hours after shot) woke up with a lump in my armpit of my right arm. Arm soreness within 15 min of shot and continues.
42 2021-04-17 guillain-barre syndrome Hospitalized for what was determined with Guillain Barre -Miller Fischer Syndrome. Symptoms slowly ... Read more
Hospitalized for what was determined with Guillain Barre -Miller Fischer Syndrome. Symptoms slowly started a couple weeks after the vaccine and eventually worsened to the point of not being able to open my mouth. Symptoms included facial paralysis, Muscle weakness, fatigue, vision issues, Neuropathy issues. I was transfused with multiple doses of Immunoglobulin and IV steroids. Still currently in Physical therapy I have lost 3 months of not being able to work. Also had a blood clot
42 2021-04-18 lymph node swelling Extreme physical pain entire body, Enlarged lymph node under arm on side of injection, Blurry vision... Read more
Extreme physical pain entire body, Enlarged lymph node under arm on side of injection, Blurry vision, Intermittent fever/cold sweat.
42 2021-04-18 swelling face At 11:47 am (12 min. after receiving vaccination), I started to feel faint, dizzy and very, very wea... Read more
At 11:47 am (12 min. after receiving vaccination), I started to feel faint, dizzy and very, very weak like I was going to pass out, heart beat rapidly, started to get flush and sweaty, hard to talk because my tongue and cheeks started to swell. We had just been waved through the exit, so husband pulled car over for another 30 min. to see if I got worse. Then went home. Arrived home at 1:30 pm and was hit with the same symptoms. Felt very, very weak like I was going to faint until about 3:30/4 pm. Then I started to feel more normal again. At midnight, I started to feel very weak again. Have not experienced any further symptoms since then.
42 2021-04-19 peripheral swelling Nausea within 30 minutes, sleepiness within 1 hour, after 3 hour nap woke up with scratchy throat an... Read more
Nausea within 30 minutes, sleepiness within 1 hour, after 3 hour nap woke up with scratchy throat and eyes & muscle weakness. Chills, sweats, fatigue, nausea, muscle weakness, loss of appetite, and irritability lasted 2 days. Day 3 woke up with swollen toes on my left foot still irritable but less fatigued. Took Aleve, drank lots of fluids. No formal treatment sought at this time.
42 2021-04-20 lymph node pain, lymph node swelling Headache, upset stomach all day 4/20/21. Swollen and sore lymph nodes 4/21/21
42 2021-04-20 swelling, lymph node swelling Swollen lymph node found on L clavicle area. Left side of neck and shoulder swelling. Pain at area. ... Read more
Swollen lymph node found on L clavicle area. Left side of neck and shoulder swelling. Pain at area. Observation at this time for two weeks per MD.
42 2021-04-21 lymph node swelling With the first Pfizer dose on 02/16/21, I experienced immediate pain at the injection site. This pa... Read more
With the first Pfizer dose on 02/16/21, I experienced immediate pain at the injection site. This pain increased and became increasingly severe and extremely intense within 5 hours of the vaccine. At that time other symptoms began to develop, including a very severe headache (crown/back of head), swollen glands and stiff neck, rapid heartrate, shortness of breath. These symptoms lasted at an intense level for 2 days, and at a moderate level for a total of 14 days (last symptoms were observed on 02/23/2021). Please also note that I started my period that month on 02/17/2021. My second Pfizer dose was on 03/9/2021, 1:40pm. (COVID19 Pfizer~BioNTech, Lot EN6205, intramuscular, left arm). I experienced mild pain at the injection site within 5 hours of the vaccine. 24 hours after the second dose I began to develop moderate/severe symptoms including headache (crown/back of head), swollen glands and stiff neck, rapid heartrate, shortness of breath. These symptoms lasted at a moderate level for a total of 14 days (last symptoms were observed on 03/23/2021. Please note that I started my period that month on 03/17/2021. This month I started my period 2 days later than usual on 04/14/2021. In addition to my regular menstrual symptoms (including migraine temporal headache and mild cramps), I experienced additional symptoms starting on 04/15/2021. These included moderate/severe headache (crown/back of head), swollen glands and stiff neck, rapid heartrate, and shortness of breath. These symptoms are still present at a moderate level today, 04/22/2021.
42 2021-04-21 swelling Pt stated the back of her tongue, feels like it is swelling, but stated that her throat doesnt feel ... Read more
Pt stated the back of her tongue, feels like it is swelling, but stated that her throat doesnt feel bad. denies SOB. At 1403, pt stated that she had a strange taste in her outh and her tongue feels tight against her teeth. at that time EMTs were paged. pt talking with EMTs reguarding medical HX and allergies. at 1440 pt is drinking water 1450 pt stated that she is ready to go home and that she is feeling better. Pt was abulatory upon leaving and walked out of the tent and drove off.
42 2021-04-22 lymph node swelling Bilateral axillary lymph node swelling, breast swelling, breast tenderness starting 12 days after va... Read more
Bilateral axillary lymph node swelling, breast swelling, breast tenderness starting 12 days after vaccination. Odynophagia starting 16 days after vaccination. All signs ongoing at time of report.
42 2021-04-23 lymph node swelling Swollen cervical and axillary lymph nodes. Pain. Extreme fatigue.
42 2021-04-24 anaphylactic reaction Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a de... Read more
Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a deep breath; dizzy lightheaded; Had tingling in my feet; headache; chest pains; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:00 (at the age of 42-year-old) (Batch/Lot Number: Ew0158) as SINGLE DOSE for covid-19 immunisation. Medical history included Asthma, anaphylactic reactions to shellfish, PCN, codeine. Known allergies included: PCN, codeine, nuts, shellfish, potatoes, green beans, apples, tomatoes. Concomitant medication(s) included loratadine (CLARITIN [LORATADINE]) taken for an unspecified indication, start and stop date were not reported; polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported. The patient took Clartin, fiber, b complex, magnesium, iron, probot in two weeks. The patient previously took first dose of bnt162b2 in left arm on 20Mar2021 at 14:15 (lot number=Er2613) for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Apr2021 02:00 AM, the patient experienced Anaphylactic reaction to vaccine. Felt like an elephant was sitting on her chest. Could not take a deep breath. She was also dizzy lightheaded. Had tingling in her feet, headache and chest pains. Most of her symptoms went away after she was given a high dose of Benadryl and prednisone. She also has asthma and a history of delayed anaphylactic reactions. It will be a 4-5 days before her lungs completely recover from this. AE Resulted in Emergency room/department or urgent care. Outcome of the events was recovering.
42 2021-04-24 axillary mass Painful lump in left armpit; administration date26Feb2021, administration date 15Mar2021; administra... Read more
Painful lump in left armpit; administration date26Feb2021, administration date 15Mar2021; administration date 26Feb2021, administration date 15Mar2021; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received bnt162b2 (COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 15Mar2021 09:45 AM (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient' medical history was not reported, no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications within 2 weeks of vaccination included: Metformin, alprazolam (XANAX) and multivitamin. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of bnt162b2 administered in Arm Left on 26Feb2021 09:00 AM for covid-19 immunization and experienced black nasal discharge. The patient experienced painful lump in left armpit since vaccines. It's been almost a month. Adverse event started from 15Mar2021 09:45 AM. No treatment was received for the event. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered. The report was non-serious. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
42 2021-04-26 lymph node pain Prickly feeling on skin started after about 3 days, mostly on legs but traveling around the body, we... Read more
Prickly feeling on skin started after about 3 days, mostly on legs but traveling around the body, went away after about 4 days, then came back around day 12 with chills and feeling run down/sick, but as more of a pins and needles/cold burn feeling, again mostly around legs, went away after a few days, came back again 4/26 as pins and needles and cold burning feeling with chills every now then, also experiencing off and on vertigo since vaccine and tinnitus, as well as painful lymph nodes in chest mostly on vaccine side starting in day 12ish post vaccine.
42 2021-04-26 lymph node swelling, lymph node pain - Around 5pm joint pain in legs, shortly after I also felt back pain...joint pain lasted for about 3... Read more
- Around 5pm joint pain in legs, shortly after I also felt back pain...joint pain lasted for about 30 hours but was eased with Tylenol and Ibuprofen on 4/23 - same day around 9:30pm I started to feel the chills, afterwards felt very hot, this was gone the next morning but started again the next night (4/23) around 7pm - morning of 4/23 strong dull headache on left side/front of head...1000mg of Tylenol did not help, took another 800mg of Ibuprofen 3 hrs later which eased the pain - my skin felt very sensitive to the touch for about 48 hours (like a burning sensation) - felt very light headed for stretches as of morning of 4/23 until evening/going to bed on 4/24 - pain and swollen lymph nodes under left armpit (started the night of 4/22 and lasted until 4/25) - felt dizzy from time to time...did last for a couple of hours each day - muscle ache in both arms and tummy started 4/27 in the afternoon ( haven't done any sport) - jaw muscle ache left side when opening mouth (started 4/26 in the evening) - cramps in my feet (started first 4/25 in the afternoon and have it at least twice daily since then)
42 2021-04-26 lymph node swelling On 4/9, let eye turned red along with burning, itching, swelling, tearing in the eye. Swelling in t... Read more
On 4/9, let eye turned red along with burning, itching, swelling, tearing in the eye. Swelling in the armpit. On 4/11, the pain in the eye became quite severe. Eye was also sensitive to light and touch. On 4/13, elevated ESR levels (67) were detected and Prednisone (60mg daily) s was prescribed. On 4/14, optometrist diagnosed iritis and prescribed Prednisone eye drops. On 4/19, further tests ruled out other possible causes for iritis and Prednisone was stopped.
42 2021-04-26 peripheral swelling Severe joint and muscular pain Red and swollen left arm
42 2021-04-27 lymph node swelling, lymph node pain Hot, fever, arm pain to the extent I couldn?t use my arm normally, sore throat, very swollen and sor... Read more
Hot, fever, arm pain to the extent I couldn?t use my arm normally, sore throat, very swollen and sore lymph nodes in neck and groin, achy, tired, no appetite
42 2021-04-27 lymph node swelling, swelling 4/16 - rash, lip swelling, tongue pain, temperature, chills, body aches, lymphadenopathy, 4/23 - ch... Read more
4/16 - rash, lip swelling, tongue pain, temperature, chills, body aches, lymphadenopathy, 4/23 - chest pain (same day as cortisone injection) 4/24 - worsening swelling, pain with swallowing 4/25 - admitted to the hospital through the ED with erythemic rash to bilateral palms, bilateral feet, back; painful, not itchy; eye red; lip swollen; tongue pain and pain with swallowing
42 2021-04-27 swelling face swelling of face, facial numbness
42 2021-04-27 swelling At about 2:30 started feeling funny. Thought I was possibly hypoglycemic but my blood sugars were 12... Read more
At about 2:30 started feeling funny. Thought I was possibly hypoglycemic but my blood sugars were 123. Then about 3:00 tasted feeling tingling in my arm and finger tips and legs. 3:30 my legs felt like they were swollen but the weren't. Noticed I was coughing more to clear my throat. And felt a little itchy on different parts of my body. Around 4:30 my husband noticed I had something on my face. Turned out to be hives. My throat area velt wierd a little numb but not completely. I felt big lumps on both sides of my neck. I then started to feel tingling on my nose and left side of my tongue. I noticed it felt a little uncomfortable to swallow almost like a sore throat but without pain. I did not feel short of breath at any time. I took 50mg of benadryl at 6pm. The symptoms started to subside. Still had occasional itching. By the morning I felt better. Throat felt better and itching was gone. I did end up taking more benadryl at about 8pm because I noticed my throat feeling swollen again. By the morning I was back to normal again.
42 2021-04-28 lymph node pain, lymph node swelling On day 2 extreme tired, low grade fever 99.2, chills, lack of appetite. Left arm hot to touch, red. ... Read more
On day 2 extreme tired, low grade fever 99.2, chills, lack of appetite. Left arm hot to touch, red. Day 3 lymph nodes under left arm were enlarged and swollen (palpable), extreme pain couldn't lift arm, chills and sweats. Day 4 lymph nodes still swollen and palpable but can lift arm to shoulder height, still lethargic. Left arm is still hard, red and hot to touch area has gone from size of golf ball to the size of an orange. Day 5 Lymph nodes are no longer palpable but still very sore. Left arm has gone from size of orange to cover most of upper arm still red and hot to touch. Day 6 Left arm is still red and covers most of upper arm not as hot. Day 7-10 left arm begins to fade redness and is now itchy. Day 12 back to baseline in all areas.
42 2021-04-28 lymph node swelling, oral herpes Awful achiness, toes, fingers everything hurts . Swollen knot or lymph node under my right arm., ti... Read more
Awful achiness, toes, fingers everything hurts . Swollen knot or lymph node under my right arm., tired, ans woke up with cold sores in my mouth
42 2021-04-28 lymph node swelling Left armpit lymph swollen and sore
42 2021-04-28 lymph node swelling I received my first dose of cover vaccine on February 20 and started having shooting pain under my r... Read more
I received my first dose of cover vaccine on February 20 and started having shooting pain under my right arm( The arm I received the vaccine), I went to emergency room and begged my pcp to see me and the ARNP said it's covid related. so I received my second shot on my left arm. I had my right under arm pain for a month and five days. then it stopped. But on April 15 my left under arm started to hurt and immediately my right underarm started hurting too. I saw a doctor he examined and said both arms axillary lymph nodes are swollen. he gave me anti bionics, I am still in pain.
42 2021-04-28 lymph node swelling ran a fever of over 103 degrees, through the day, on the day after the shot; did not seek medical at... Read more
ran a fever of over 103 degrees, through the day, on the day after the shot; did not seek medical attention since Tylenol helped the fever go down intermittently. Fever was gone two days after shot. Two days after shot, woke up with swollen armpit (on side of injection); armpit swelling has gone down but is still present on third day after shot
42 2021-04-28 swelling Received 2nd shot on April 24. Started having adverse reaction on April 27. Itchy rash, swelling and... Read more
Received 2nd shot on April 24. Started having adverse reaction on April 27. Itchy rash, swelling and hot to touch.
42 2021-04-29 peripheral swelling, swelling Arm pain, swelling of the arm, shoulder, neck and a ball under the arm. Headache, sweating, itching ... Read more
Arm pain, swelling of the arm, shoulder, neck and a ball under the arm. Headache, sweating, itching all over the body and muscle aches. I feel like a lump in my throat and I feel very tired.
42 2021-04-29 peripheral swelling On the afternoon of 4/29/2021 at 2pm, patient came to the pharmacy after receiving her second Pfizer... Read more
On the afternoon of 4/29/2021 at 2pm, patient came to the pharmacy after receiving her second Pfizer-Biontech COVID-19 vaccine on 4/27/2021 at 1pm. She spoke with pharmacist regarding side effects. She stated that on 4/27/2021 after receiving her vaccine, she woke up in the evening around 8pm feeling soreness in her arm and tingling that radiated from the injection site in the left deltoid muscle to the tips of her fingers. She told the pharmacist that on the following day 4/28/2021 at around 1pm she took some Tylenol for the pain. She noticed at that point that her arm and fingers were swollen, numb, and that she could not fully close her hand. When she appeared at the pharmacy on 4/29/2021, she stated that her ability to move her hand had returned, but that the swelling and numbness were still the same. Pharmacist observed that her arm around the injection site was warm and swollen. She advised the patient to contact her medical provider for further evaluation and in the meantime continue to use Tylenol (the patient could not use anti-inflammatory medications due to a medical condition) and apply cold compresses to the arm. She also requested the patient to contact the pharmacy for any further questions and to provide an update the following day on 4/30/2021. On 4/30/2021, pharmacist reached out to the patient at 10am to follow up. The patient stated that swelling and numbness in the hand had decreased, but the tingling sensation was still present. She is planning on following up with a medical provider today.
42 2021-04-30 anaphylactic reaction, lymph node swelling Began with hives on hands and neck area 3 days after covid vaccine, I took benadryl before bed and ... Read more
Began with hives on hands and neck area 3 days after covid vaccine, I took benadryl before bed and woke the next morning to hives spreading to entire body. I took another dose of benadryl mid day. By evening I was in anaphylaxis with swollen lips and itchy gums. Went to the ER and received ephnephrine, intravenous benadryl, pepcid and prednisone. Was monitored for 3 hours, swelling was gone and symptoms had subsided. Went home. Next morning symptoms were less but feet were tender to walk on and hands and feet were itchy. Picked up prescrription prednisone and loratadine and took both that morning. By evening afternoon was very itchy and hives on back, legs, arms and neck took benadryl that evening which helped but currently itchy red hives on arms, hands, neck, legs and feet - all over body. A new symptom is very swollen lymph nodes in neck.
42 2021-05-01 lymph node inflammation, lymph node swelling, lymph node pain Vaccine at 10:30 am; general malaise onset around 1 pm; sore arm started around 4 pm; body aches, in... Read more
Vaccine at 10:30 am; general malaise onset around 1 pm; sore arm started around 4 pm; body aches, injection site was hot; chills/hot flashes started around 8:30 pm; insomnia; joint pain. lymph node tenderness. Symptoms were mild - medium (not severe). Mostly uncomfortable. 24 hours lymph node under injection arm swollen - and as of now it still is. the only remaining symptom at 7 am 5/2 is swollen armpit / lymph node on injection arm.
42 2021-05-02 lymph node pain, lymph node swelling Visibly swollen lymph nodes under both arms (armpits), painful to the touch and tenderness radiating... Read more
Visibly swollen lymph nodes under both arms (armpits), painful to the touch and tenderness radiating into the outer breast tissue and down the arms; spiderweb bruising under the armpits
42 2021-05-02 lymph node swelling On April 20, 2021, two days after I received my second dose of Pfizer, I felt that my lymph nodes in... Read more
On April 20, 2021, two days after I received my second dose of Pfizer, I felt that my lymph nodes in my left armpit were swollen. I received the dose in my left arm. This symptom was observed in the morning and other than that, I had no other symptoms. Later, around seven in the evening, I noticed that my throat felt very sore and my chest began to hurt. My temperature was in the mid- 99's and I felt tired. The following day, my symptoms increased and my head began to ache, my lower back ached, my chest felt heavy, and my sinuses felt full and pressurized. My temp went above 100 and I then scheduled for a rapid covid screen. I tested positive and my symptoms lasted through Friday, April 30, 2021. My chest held a lot of congestion and this took several days to break up.
42 2021-05-03 lymph node swelling VERY BAD NASAL AND SINUS CONGESTIONS THAT LASTED FOR A WEEK OF THE FIRST DOSIS FOR THE SECOND DOSIS... Read more
VERY BAD NASAL AND SINUS CONGESTIONS THAT LASTED FOR A WEEK OF THE FIRST DOSIS FOR THE SECOND DOSIS I DEVELOPED SWOLLEN LIMPH GLAND ON THE PELVIS
42 2021-05-03 lymph node swelling fibromuscular dysplasia; 3 artery dissections; narrowing of other arteries; chills; aches; fever 101... Read more
fibromuscular dysplasia; 3 artery dissections; narrowing of other arteries; chills; aches; fever 101; left neck and chest swollen lymph nodes; stomach aches; abdominal pain; It also affected a renal artery, causing lack of blood to my left kidney, causing part of that kidney to die; heart attack; left flank pain; This is a spontaneous report from a non-contactable consumer (patient). A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on left arm on 19Jan2021 (Batch/Lot Number: EL3249) as SINGLE DOSE for covid-19 immunisation. Medical history included post-partum hypothyroidism. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK9231) via an unspecified route of administration on left arm on 29Dec2020 for covid-19 immunisation. The patient stated "The day after second vaccine and that week, I had chills, aches, fever 101, left neck and chest swollen lymph nodes, stomach aches. 28Jan2021, I started having severe left flank pain and abdominal pain. On 04Feb2021, I had a heart attack, was in V-fib arrest, and subsequently found to have fibromuscular dysplasia (FMD), which caused 3 artery dissections and narrowing of other arteries. Did not know I had FMD prior to the heart attack. Most people who have FMD never show signs or symptoms and don't know they have it. Others with FMD have it affect maybe one artery. Something caused my FMD to go into overdrive, affecting 3 arteries. It also affected a renal artery, causing lack of blood to my left kidney, causing part of that kidney to die - that was my 28Jan2021 pain. Coincidental my FMD acted up this way a little over a week after receiving the second Pfizer shot?" Events were reported as serious and resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization, Life threatening illness (immediate risk of death from the event). The patient hospitalization for 9 days. Treatment received for all events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): negative on an unknown date (Covid test post vaccination). The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
42 2021-05-03 peripheral swelling, c-reactive protein increased 2 weeks after first vaccine developed myalgias and arthralgias. These symptoms progressed and worsen... Read more
2 weeks after first vaccine developed myalgias and arthralgias. These symptoms progressed and worsened over time and especially after the second vaccine. She developed swelling in hands and feet and moderate to severe pain in muscles and joints requiring pain medications. The swelling and pain responded to prednisone but soon recurred after completing the prednisone.
42 2021-05-05 lymph node pain, lymph node swelling My 2nd vaccine injection was in April 26. The next day the lymph node at my collar bone was very swo... Read more
My 2nd vaccine injection was in April 26. The next day the lymph node at my collar bone was very swollen and tender. This continued for several days until May 4th when the lymph node was no longer visibly swollen or tender to touch; however, muscle soreness in my shoulders and neck, as well as a right sided headache, has unexpectedly set in.
42 2021-05-05 lymph node swelling nausea, started within 15minutes of vaccination, waxing and waning, still present, responsive to ond... Read more
nausea, started within 15minutes of vaccination, waxing and waning, still present, responsive to ondansetron abdominal pain, started within 1 hour of vaccination, waxing and waning, worse 24 hrs after vax, still present, no improvement with medication (antacids, simethicone, ondansetron) or bland diet diarrhea, started within 36hrs after vaccination, still present, no tx fever, started within 12hrs of vaccination, poorly responsive to tylenol, improved but not resolved within 36hrs headache (severe), started within 1hr of vaccination, worse 8 hours after vaccination, improved after 36hrs, only after ibuprofen, no improvement with tylenol moderate muscle pain (generalized), started within 8hrs of vaccination, mostly resolved within 24hrs, tylenol and ibuprofen lymphadenopathy - multicentric (mostly cervical and axillary), started approx 36hrs after vax, still present fatigue - started within 8hrs of vaccination, improved within 36hrs of vaccination, tx - rest, tylenol, ibuprofen (1dose)
42 2021-05-06 c-reactive protein increased Dull chest pain which increased with deep breath or bending over. Blood tests revealed extremely ele... Read more
Dull chest pain which increased with deep breath or bending over. Blood tests revealed extremely elevated Tropinin-i and CRP levels. Required hospital stay, for 2 days
42 2021-05-06 lymph node pain, lymph node swelling supraclavicular lymph node swelling/tenderness to L supraclavicular lymph node; watchful waiting and... Read more
supraclavicular lymph node swelling/tenderness to L supraclavicular lymph node; watchful waiting and taking NSAIDs OTC recommended for now. if no improvement, will proceed w/ CBC and u/s of neck and consider possible abd xray
42 2021-05-06 lymph node swelling Got the shot on right Arm. Under Armpits, I can feel and touch swelling of lymph nodes. It hurts.... Read more
Got the shot on right Arm. Under Armpits, I can feel and touch swelling of lymph nodes. It hurts. No fever or other symptoms.
42 2021-05-07 anaphylactic reaction flu-like symptoms; given an injection of steroids/difficulty breathing; difficulty breathing; fever ... Read more
flu-like symptoms; given an injection of steroids/difficulty breathing; difficulty breathing; fever 100F; chills; body aches; chest tightness; abdominal pain; This is a spontaneous report from a contactable other HCP (patient). This 42-year-old female other HCP reported for herself received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 12Mar2021 10:00 (Batch/Lot Number: EN6206) as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunisation. Medical history included asthma (well controlled prior to vaccine) migraines, chronic UTI, bronchitis, pneumonia, all from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction ("given an injection of steroids/difficulty breathing") on 13Mar2021 with outcome of not recovered , difficulty breathing on 13Mar2021 with outcome of not recovered , fever 100F on 13Mar2021 with outcome of not recovered , chills on 13Mar2021 with outcome of not recovered , body aches on 13Mar2021 with outcome of not recovered , chest tightness on 13Mar2021 with outcome of not recovered , abdominal pain on 13Mar2021 with outcome of not recovered , flu-like symptoms on 15Mar2021 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature: 100F on 13Mar2021 , oxygen saturation ("O2 stats"): between 88-93 for 3 weeks, sars-cov-2 "antibody" test: positive on 16Apr2021 (blood test) , CXR with unknown result on 17Mar2021. Therapeutic measures were taken as a result of the reported events included injection of steroids and antibiotics.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-05-07 oral herpes I was diagnosed with oral and genital herpes; I was diagnosed with oral and genital herpes; This is ... Read more
I was diagnosed with oral and genital herpes; I was diagnosed with oral and genital herpes; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Feb2021 (Batch/Lot Number: EL9269) (at the age of 42-years-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant. The patient's concomitant medications were not reported. There were no other vaccines received in four weeks. The patient previously took droperidol and experienced allergy; nortriptyline and experienced allergy. The patient was not diagnosed with COVID prior to vaccination. The patient was diagnosed with oral and genital herpes on 08Mar2021, which was a complete shock to the patient. The patient stated that it's some kind of side effect to the vaccine. The events required a visit to the doctor's clinic. The event was treated with an unspecified medication. The reporter considered the event as serious (disability). The patient underwent lab tests and procedures which included nasal swab COVID test: negative on 20Mar2021. The outcome of the events was recovered with sequelae. No follow-up attempts are possible. No further information is expected.
42 2021-05-07 swelling -lightheaded -weakness in legs -tingling in the head, face and strange sensations that would go fro... Read more
-lightheaded -weakness in legs -tingling in the head, face and strange sensations that would go from the top of my head and go down my body -heart palpitations -general cloudiness in the head one night I woke up and had to concentrate very hard to think and to speak like having a stroke -numbness in face -face felt swollen for a day or two -itchy for a day 3 weeks later and some of these have subsided, but I still feel off and on tingling, strange sensations, lightheaded and weakness at times.
42 2021-05-07 swelling 2days after shot, redness and pain at lef arm administered area. At the same time, Redness, pain,, ... Read more
2days after shot, redness and pain at lef arm administered area. At the same time, Redness, pain,, warmth, swelling at epidermoid cyst at mid chest, seems cyst ruptured. Arm swelling became better, however 8 days later, injestion site became red, hot swollen with itchness. Redness became bigger at lest arm and stared taking benadrl daily. Redness of lest arm improved but still red today 5/8/21. Cyst at midchest is still red. Pending to see dermatologist on 5/11/21.
42 2021-05-08 lymph node swelling Felt a spark in my left elbow the same day. Severe left side and body pain the next day. Felt my he... Read more
Felt a spark in my left elbow the same day. Severe left side and body pain the next day. Felt my heart pumping faster than usual for about 3 hours. Almost all the symptoms subsided by the next day but lymph nodes in the left arm pit and elbow got enlarged. Don't feel the lymph nodes now but severe elbow pain now. Can't lift heavy things. It's even painful when I bend and straighten the elbow.
42 2021-05-10 swelling face There was a full, tingling feeling in my right cheek, below my eye almost immediately after the shot... Read more
There was a full, tingling feeling in my right cheek, below my eye almost immediately after the shot. Four days later, I developed stinging and swelling ion the outside of that same eye and underneath. Today is day 6 and my right eye and cheek are still swollen, itchy and burning.
42 2021-05-12 lymph node swelling 14 hrs after-102.9 temp, sever chills and hot sweatshirt; 14-32 hrs after- between 101.4 and 102.9 ... Read more
14 hrs after-102.9 temp, sever chills and hot sweatshirt; 14-32 hrs after- between 101.4 and 102.9 temp, severe chills, hot sweats, migraine, body aches; 33-49hrs after- 103.9 temp several times with a low of 102.4. Severe chills, severe hot sweats, migraine, dizziness, heaviness in chest swollen lymph nodes at collar, abdominal pains 50-68 hrs after- 101 temp decreasing to 100.4. Migraine, abdominal pain, dizziness, lymph nodes at collar and armpits swollen badly, arm at shot site extremely red, hot, swollen, hard and itchy; 69-82 hrs after- temp between 99.7 and 100.1.Migraine, nausea, abdominal pain, dizziness, lymph nodes at collar and armpits swollen badly, arm at shot site extremely red, hot, swollen, hard and itchy.
42 2021-05-14 lymphatic obstruction, lymph node swelling, lymph node pain 1 week following second dose of vaccine, left subclavicular lymohnode became swollen and tender. Che... Read more
1 week following second dose of vaccine, left subclavicular lymohnode became swollen and tender. Chest x ray showed no findings. Two months later lymoh node edema persisted and I had a chest/abd/pelvic ultrasound which indicated a 4.5 cm mass in left lung, possible metastasis to the spine, liver, and now shows metastasis to the brain in recent brain MRI. CT scan findings confirmed by biopsy indicating adenocarcinoma.
42 2021-05-14 swelling face pt complained of not feeling well, redness in the vaccinated arm visible, pt then complained of swel... Read more
pt complained of not feeling well, redness in the vaccinated arm visible, pt then complained of swelling of throat, swelling of face and lips evident, epi 0.3mg administered per protocol
42 2021-05-15 peripheral swelling, lymph node swelling started the day of vaccines with a sore arm later on in the evening sore arm near shoulder where vac... Read more
started the day of vaccines with a sore arm later on in the evening sore arm near shoulder where vaccine was given for about 24 hours and then it seemed fine about a week later arm started hurting halfway down my upper arm there is a lump on the outside my arm is swollen lymph nodes are swollen the arm feels tight and tired sometimes get tingly sensations in it. I was supposed to receive my second vaccine on May 8 did not get it because of the reaction that I am still experiencing would like to get the second one I am very scared considering I am still having A very painful reaction
42 2021-05-15 peripheral swelling Painful swollen and bruised part of my left leg and left arm.
42 2021-05-17 lymph node swelling Starting in feb i had pain in my left arm. specifically the tendons. then pins and needles started ... Read more
Starting in feb i had pain in my left arm. specifically the tendons. then pins and needles started in my left arm soon after my second shot in march. After second shot i had swelling in my arm pit, chills and fatigue, and some brain fog. On 4/14 i went to the dr and he said i probably hurt my elbow and told me to start taking aleve 2 times a day. on 4/19, i woke up with extreme dizziness. In the morning and at night. I had significant brain fog as well. then pins and needles started in my face and neck. i went back to the dr on 4/19 they started treating me for lymes disease. I had extreme tightness in the back of my neck and base of skull. The brain fog has started to lift. The pins and needles have started to isolate to my chin lips and 1 arm. I still have dizziness although it has become more manageable.
42 2021-05-17 peripheral swelling Numbness and Pain in Left Hand following Second Pfizer Shot. Joints at Left Pointer and Middle Fing... Read more
Numbness and Pain in Left Hand following Second Pfizer Shot. Joints at Left Pointer and Middle Finger Red, "on fire".....Left Hand Swollen. I cannot lift, type, open doors, hold a coffee cup, tie my shoes, put earrings in, etc.
42 2021-05-17 swelling Second dose of Pfizer, I got the same reaction that many are reporting about the moderna. ?Covid arm... Read more
Second dose of Pfizer, I got the same reaction that many are reporting about the moderna. ?Covid arm? I had a bit of swelling, redness and large red circle around.
42 2021-05-18 swelling Pain, fever, swelling, hard knot at injection site, chest pressure, shortness of breath, throat feel... Read more
Pain, fever, swelling, hard knot at injection site, chest pressure, shortness of breath, throat feel like it was swelling shut, cough, difficulty talking. The chest pressure began Sunday morning and readily got worse eventually resulting to a trip to the ER when Benadryl, rescue inhaler, and EPI pen didn?t work.
42 2021-05-20 peripheral swelling, swelling face Patient developed swelling of the face, abdomen, extremities with noticable changes. Also had an ass... Read more
Patient developed swelling of the face, abdomen, extremities with noticable changes. Also had an associated rash of the neck and ears. Patient also gained 14 lbs during the reaction. Patient was evaluated by previous physician and treated with steroid injection + oral steroid pack. Patient also has been taking her oral antihistamines regularly when she used to take it PRN for her celiac flare. Since being treated, facial swelling has reduced but neck is still bigger than prior to the incident. The 14 lb weight gain has remained and has not been able to lose any with diet and exercise. Patient received Pfizer 2nd shot without any adverse reaction.
42 2021-05-20 swelling face Pfizer vaccine - tongue swelled impeding speech, face swollen, tingling in the face, hives on face a... Read more
Pfizer vaccine - tongue swelled impeding speech, face swollen, tingling in the face, hives on face and neck. This passed within 24 hours Tingling in hands and feet - started within five hours of shot has not improved.
42 2021-05-21 swelling, swelling face Pt started to have facial and neck swelling, pain and tightness in throat and difficulty with breath... Read more
Pt started to have facial and neck swelling, pain and tightness in throat and difficulty with breathing x12 hours before coming into ED.
42 2021-05-22 c-reactive protein increased Mild fatigue and headache day after first shot only, and mildly sore arm for a week or so. After sec... Read more
Mild fatigue and headache day after first shot only, and mildly sore arm for a week or so. After second shot -3 days very sleepy, increased chest pain, increasing activity intolerance, then less sleepy but severe activity intolerance, palpitations and tachycardia sitting up for extended periods, SOB with walking distances or stairs and sharp chest pains again, waking from sleep SOB, unable to tolerate lying flat on back with SOB. It was like much earlier in the long Covid again. About 1 month after the vaccine I took prednisone 20mg for 5 days, against medical advice and all symptoms improved, to just a little worse than before the vaccine. My mother had a similar reaction to the first dose and was hospitalized, and got no testing or treatment, just monitoring. She had Covid at the same time as me.
42 2021-05-23 lymph node swelling, lymph node pain Painful swelling of the lymph node in left clavicle area
42 2021-05-24 lymph node swelling dose 1: 05Jan2021; dose 2: 22Jan2021; dose 1: 05Jan2021; dose 2: 22Jan2021; ear ache; Cough; congest... Read more
dose 1: 05Jan2021; dose 2: 22Jan2021; dose 1: 05Jan2021; dose 2: 22Jan2021; ear ache; Cough; congestion; loss of appetite; Headaches; fatigue; right axillary lymph node swollen; Dizziness; Room spinning; nausea; body and face tingling; chills; body aches; insomnia; This is a spontaneous report from a contactable nurse reporting for herself. This 42-year-old female nurse (Patient) reported that: A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 via an unspecified route of administration, administered in Arm Right on 22Jan2021 11:00 AM (Batch/Lot Number: EL3249) as SINGLE DOSE for COVID-19 immunization. Patient also received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 05Jan2021 09:30 AM, (Batch/Lot Number: EK9231) as SINGLE DOSE for COVID-19 immunization (time interval between two doses: 18 days). Medical history included drug hypersensitivity, to Penicillin, tetracycline. Concomitant medication included cetirizine hydrochloride (ZYRTEC) 1x/day and Multivitamins. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not test COVID post vaccination. On 22Jan2021 10:00 PM, the patient experienced dizziness, room spinning, nausea, body and face tingling, chills, body aches and insomnia. Also, it was reported that, the patient had fatigue, right axillary lymph node swollen on 23Jan2021, on 24Jan2021: dizziness had nausea. On 26Jan2021: Dizziness, nausea, loss of appetite, tingling face and body and headache. On 27Jan2021: Dizziness, nausea, tingling face and body, cough, congestion and on 28Jan2021: Cough, congestion, earache. On 29Jan2021, the patient presented with dizziness, tingling face and body, cough congestion, and headache. The AE resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for adverse events. The patient was recovering from all the event at time of reporting. Follow-up attempts are completed. No further information is expected.
42 2021-05-25 swelling face MY EYE BROWS SWELLED; DIZZINESS; CRAVED BLACK LICORICE LIKE MAD; MASSIVE EYE TEARING; HAD A RIGHT SI... Read more
MY EYE BROWS SWELLED; DIZZINESS; CRAVED BLACK LICORICE LIKE MAD; MASSIVE EYE TEARING; HAD A RIGHT SIDED FRONTAL HEADACHE; POST NASAL DRIP; I FELT LIKE I WAS AT HIGH ALTITUDE WHICH LASTED FOR 36-48 HOURS.; This is a spontaneous report from a non-contactable non-health care professional. A 42-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 mRNA Vaccine) (Lot/batch no: EN6199) dose number 1 via unspecified route of administration on left arm as a single dose for COVID-19 immunisation on 04Mar2021 at 06:30 PM (at the age of 42-year-old). Medical history included allergy to gold. Concomitant medication was not provided. Reported patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced dizziness within the first 15 minutes. Within the first hour her eye brows swelled and she had a right sided frontal headache. 2 hours later she felt like she was at high altitude which lasted for 36-48 hours. The swelling broke during the night with massive eye tearing and post nasal drip. She craved for black licorice like mad on 04Mar2021. The action taken was not applicable. Therapeutic measures were taken as a result of events and included self-treatment with ice pack, tylenol, and clairitin from an unknown date. The patients recovered from the events dizziness, eye brows swelled, frontal headache, massive eye tearing and post nasal drip was recovered. No follow-up attempts are needed. No further information is expected.
42 2021-05-27 lymph node swelling Feeling sensitivity in my veins like I could feel pulses in my veins in my whole body; irregular hea... Read more
Feeling sensitivity in my veins like I could feel pulses in my veins in my whole body; irregular heart beat; Rapid Heart Beat palpitations; raising heart beat along with heart palpitations; irregular heart beat; Lymph node swollen; I woke up to a very neauseal senation and feeling that I was going to faint; Dizziness; I woke up to a very neauseal senation and feeling that I was going to faint; Shivering; Warm eye; Feeling like a very bad cold or flu; Feeling like a very bad cold or flu; Headache; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 22Apr2021 (at the age of 42-year-old) (Batch/Lot Number: ER8735) as UNKNOWN, SINGLE for covid-19 immunisation. It was unknown if patient was pregnant at the time of vaccination. The patient had no relevant medical history. Concomitant medication included multivitamins. The patient stated, "So, in chronological order I got the vaccine on April 22. Okay So, my first symptom that night on April 22 was headache, then on April 23rd Friday, I had symptoms of shivering body, headache, warm eye, just feeling like very bad cold or flu like. Then on Friday night to Saturday, so you can chronologically, April 24, 4 am I woke up to a very neauseal senation and feeling that I was going to faint which scared me a lot, I was supposed to go ER, but I didn't, I just you know calmed down, given it was 4 a.m. in morning and don't want to scare my family and that was very scary symptom. April 25 I felt my lymph node swollen and ever since April 24 I had dizziness. So, I would feel dizzy from time to time particularly in the middle of the night like 4 am that's when I felt the dizziest. The nausea was very very persistent like I felt like I needed to throw up but I didn't on the 24 of April but then on 25th and onwards I continued with dizziness felt without nausea just being dizzy. On Tuesday April 27, I started having a rapid heartbeat palpitations and that started scaring me even more. So on Thursday April 29, I started feeling sensitivity in my veins like I could feel pulses in my veins in my whole body along with raising heart beat along with heart palpitations so I went to a minor emergency room provider. They told me I had to hydrate properly, rest, not exercise and to allow for the vaccine to make it through my body because the symptoms that last up to two weeks and they suggested that if I still felt like I was gonna faint, I have to visit the emergency room. Fortunately, I didn't have to visit the emergency room but my heart palpitations, my regular heart palpitations have continued. So, I am now on beyond my 2nd week and today I scheduled the call with a cardiologist because I have a heart, you know pulse monitor, pressure monitor that takes your pressure and I wear a fitness watch and I can see in my fitness watch how my heart reaches over 120 palpitations. So, I scheduled with cardiologist for next week Tuesday and the dizziness has gone away for the most part. It's incredibly minor if I feel it but at times I feel it. But I don't like irregular heart beat and last night my pressure monitor told me, detected it because you have to detect it at right time, it's not all the time but the monitor was able to detect the irregular heart beat at 79 pulses and my regular heart beat is more like 64." The patient also stated that her doctor told her that what she was feeling her vein was reaction to her nerve system from the vaccine. So he suggested that she soak in bath tub salt, which she have been trying to as best as she can but that really was relief like she don't have feelings of sensitivity in the vein anymore the only thing that continues was regular heart beat. The patient took only Tylenol 500mg, one capsule every 6 hours, orally for the headache and after headache was gone, the patient stop taking Tylenol and then she have been trying soaking in of absence salt and she have been trying to drink plenty of fluids among which includes beverages with electrolytes. Therapeutic measures were taken as a result of headache, flu, and "feeling sensitivity in my veins like i could feel pulses in my veins in my whole body." On an unspecified date, the patient recovered from headache and "Feeling sensitivity in my veins like I could feel pulses in my veins in my whole body" and was recovering from dizziness. The patient had not yet recovered from irregular heart beat while outcome of the rest of the events was unknown.
42 2021-05-28 lymph node swelling Left supra-clavicular swollen lymph node(s). Tightness at sight. Swelling is about 2 inches in diame... Read more
Left supra-clavicular swollen lymph node(s). Tightness at sight. Swelling is about 2 inches in diameter. There is currently no redness or pain. Spoke to nurse. Monitoring symptom.
42 2021-06-02 lymph node swelling, peripheral swelling Fever; chills; severe headache; fatigue; swollen lymph nodes; sore throat; body aches; LARGE, INFLAM... Read more
Fever; chills; severe headache; fatigue; swollen lymph nodes; sore throat; body aches; LARGE, INFLAMED, RED MASS 1-2 INCHES BELOW INJECTION SITE. Extreme and sustained pain and swelling of the arm. Hot to the touch. Tingling from jawline on left side of face to fingertips of left hand persists after 50+ hours post-injection. Swelling on arm is approximately 6 inches in diameter. The red, concentrated area is approximately 3 inches wide by 2 inches high at the center of the swelling.
42 2021-06-02 peripheral swelling, lymph node swelling About 12 hours the first vaccine: body ache, chills, low grad fever (99.1), exhaustion. These sympto... Read more
About 12 hours the first vaccine: body ache, chills, low grad fever (99.1), exhaustion. These symptoms went away in about 48 hours. A few days after the first does, swelling of both lymph nodes in left and right arm pits and inflammation in the palm of my hand under the middle finger. The lymph node swelling went away in about one week. The hand inflammation is still present. About 12 hours after the second vaccine: body ache and extreme exhaustion and brain fog. These symptoms went away after 24 hours. A few days after the second does, swelling of both lymph nodes in left and right arm pits. The swelling symptoms went away after about one week.
42 2021-06-03 lymph node swelling, lymph node pain 101.3 degree fever, chills, sweating, nausea, vomiting, diarrhea, swollen lymph nodes, axillary lymp... Read more
101.3 degree fever, chills, sweating, nausea, vomiting, diarrhea, swollen lymph nodes, axillary lymph node pain, migraine, photophobia, lack of appetite, fatigue, malaise
42 2021-06-03 lymph node swelling I've experienced swollen lymph nodes on Left side only; a bad taste in my mouth/ metallic taste; Thi... Read more
I've experienced swollen lymph nodes on Left side only; a bad taste in my mouth/ metallic taste; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: not reported), via an unspecified route of administration, administered in in arm left on 01Feb2021 07:30 AM (at the age of 42-year-old), as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included atenolol, lisinopril, tizanidine hydrochloride (ZANAFLEX), and omeprazole. Patient previously took BNT162B2 first dose administered in in arm left for covid-19 immunization. Patient did not have COVID prior vaccination. Patient did not have other vaccines in four weeks. Patient has not tested covid post vaccination. No known allergies. On 01Feb2021 07:45 AM the patient experienced adverse event and reported that "I have experienced swollen lymph nodes on Left side only. But a bad taste in my mouth since the 2nd shot on 01Feb2021. over 4 weeks. It is a terrible metallic taste". Patient did not receive treatment for the adverse events. Outcome of the events was not resolved. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
42 2021-06-03 lymph node swelling Chills; Low grade fever; Shoulder pain; left arm pain; back pain; swollen lymph node in left axillar... Read more
Chills; Low grade fever; Shoulder pain; left arm pain; back pain; swollen lymph node in left axillary area; fatigue; headache; This is a spontaneous report from a contactable pharmacist, the patient. A 42-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 15Mar2021 at 11:15 hours (at the age of 42-years) as a single dose for COVID-19 immunisation. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 22Feb2021 at 11:15 hours as a single dose for COVID-19 immunisation. The patients medical history included hypertension. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included hydrochlorothiazide (MANUFACTURER UNKNOWN) 12.5 (unit unspecified) once daily (QD). The patient received this medication within 2 weeks of vaccination and exact therapy dates and indication for it was not reported. On 16Mar2021, the patient experienced chills, low grade fever, shoulder pain, left arm pain, back pain, swollen lymph node in left axillary area, fatigue and headache. The patient received Motrin as a treatment medication. On an unknown date in Mar2021, the patient was recovered from the events chills, low grade fever, shoulder pain, left arm pain, back pain, swollen lymph node in left axillary area, fatigue and headache. No follow up attempts are needed. No further information is expected.
42 2021-06-03 lymph node swelling mild swelling and tenderness at the injection site, small pea-sized lumps in her left armpit
42 2021-06-03 peripheral swelling light chest pain - swelling to l arm no SOB no sweating pain subsides after few minutes BP: 155/95... Read more
light chest pain - swelling to l arm no SOB no sweating pain subsides after few minutes BP: 155/95 pulse 72 second reading BP: 179/130 pulse 77 CODE CAMPUS ACTIVATED patient sent to the ER via 911 for further evaluation
42 2021-06-03 peripheral swelling I had the vaccine and the next day my arm started swelling and the temperature of that arm was 104 a... Read more
I had the vaccine and the next day my arm started swelling and the temperature of that arm was 104 and the other arm was 96.1. My blood pressure went up to 183/101. The next day it was 163/91, I had to make an appointment with my doctor because it was stroke level and my resting heart rate was 99. They did and EKG which was normal, they took my blood pressure at the beginning and end it was roughly about the same. She gave me blood pressure medication. After a week she gave me a second blood pressure in addition to that one because my blood pressure was not coming down. After 2 weeks I started to noticed some changes. She said I should finish the medications and if my blood pressure goes to low I should stop using them.
42 2021-06-05 swelling face Lower back pain 2 days after first dose 3/27, Shingles 2 days after second vaccine on 4/21 Facial fi... Read more
Lower back pain 2 days after first dose 3/27, Shingles 2 days after second vaccine on 4/21 Facial filler edema on 6/5/21 received 2 months prior to first vaccine
42 2021-06-06 lymph node pain, lymph node swelling Swollen Lymph node in neck on the side of the injection (right side). I noticed on June 3 , two days... Read more
Swollen Lymph node in neck on the side of the injection (right side). I noticed on June 3 , two days after the vaccination. I woke up and the node was huge and sore/itchy.
42 2021-06-06 swelling, anaphylactic reaction, lymph node swelling Anaphylaxis sharp pain left side by chest swelling in nape of neck by thyroid extreme sinus pressur... Read more
Anaphylaxis sharp pain left side by chest swelling in nape of neck by thyroid extreme sinus pressure between eyes tongue swelled glands under ears swelled throat swelled. Epi pen given by HCP in pharmacy
42 2021-06-08 swelling face, peripheral swelling, swelling Swelling of face, neck, arm, and leg on the left side.
42 2021-06-13 lymph node swelling Lymph-nods under left armpit/breast area (side where I received injection) were enlarged. Went in f... Read more
Lymph-nods under left armpit/breast area (side where I received injection) were enlarged. Went in for a routine mammogram and have been instructed to return in 3 months to ensure swelling has subsided. Also, my regular 28 day periods for my entire life (sans pregnancy) have been extremely abnormal, with almost daily spotting and irregular cycles and symptoms.
42 2021-06-14 lymph node swelling I started having pain under my right arm in the armpit area and my right breast as well. It is not c... Read more
I started having pain under my right arm in the armpit area and my right breast as well. It is not completely gone yet. I had a mammogram done that showed swollen lymph nodes in the affected area. A fibroadenoma mass that was biopsied by the doctor. I saw an ob/gyn that referred me to have a mammogram and diagnostic ultrasound. The breast surgeon noted the mass and the swollen nodes. The biopsy came back benign. I have another mammogram scheduled in the near future. The pain has decreased but it is still tender and swollen. The doctor said depending on how things progress, the mass could either get removed or remain under observation.
42 2021-06-16 oral herpes Cold sore on roof of mouth and on inner lower lip; This is a spontaneous report from a contactable c... Read more
Cold sore on roof of mouth and on inner lower lip; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 42-years-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01May2021 at 12:15 (Batch/Lot Number: EW0172) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation at Pharmacy or Drug Store (42-years-old at the time of vaccination). Patient received first dose of (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 10Apr2021 12:00 (Batch/Lot Number8729) for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing and there were no allergies. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM), fluoxetine hydrochloride (PROZAC), ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. Post or prior to the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021, the patient experienced cold sore on roof of mouth and on inner lower lip. Patient did not receive any treatment for the event. The clinical outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
42 2021-06-16 swelling, peripheral swelling Joint pain; Joint pain was reported as worsened; My sedimentation rate was elevated/SED rate was, th... Read more
Joint pain; Joint pain was reported as worsened; My sedimentation rate was elevated/SED rate was, the one thing that was elevated; My ANA came back positive but it was at 140; My feet look swollen, my fingers look swollen. Its all over my body; My feet look swollen, my fingers look swollen. Its all over my body; I mean its breaking me up; Its extremely bad for me; Swelling at the joints; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered on 25Mar2021 13:00 (Batch/Lot number was not reported and Expiration Date: Unknown) as 1st dose, Single Dose on left shoulder and dose 2 intramuscularly, administered on 15Apr2021 13:15 (Batch/Lot number was not reported) (at the age of 42-year-old) as 2nd dose on right shoulder as Single Dose for COVID-19 immunization. Medical history included Epstein Barr virus from Feb2020 to an unknown date, Birth control from an unknown date and unknown if ongoing. Concomitant medication(s) included ethinylestradiol, norethisterone (ALYACEN) taken for birth control (don't know the dosing on it), start and stop date were not reported. The patient did not receive any other vaccine 4 weeks prior to the first COVID shot. Patient did not have any family history related to Joint pain. On Mar2021, joint pain was reported as worsened. On 25Mar2021, the patient had extreme joint pain and it came out of nowhere and never had joint pain prior to vaccine. She went back to doctor several times they tested me they done lab work to try to figure out somehow if she had get a lupus or something else and it is like unexplained swelling at the joints (2021) and it just won't seem to go away. The patient had developed Epstein Barr virus when COVID started Feb2020, but she was testing it prior to make sure. She wasn't active for the virus but came up with inactive that was the only thing going on but I did have concern getting the shot and they said she was safe because my she have inactive virus it was dead virus now. The patient stated that she was tested for all kinds of test when it started and the SED rate was, the one thing that was elevated was my sedimentation rate was elevated (2021) and then my ANA (Antinuclear antibody) came back positive but it was at 140 (2021) which is not positive and everything else appears to be normal. The patient further stated and getting worsened right after the shot it was after the first 6 weeks it was coming and going in route, like I had it and kind of away and it seems like early May at for few days it seems like it was completely gone and then as time has progress as we got to the end of May it came back a million times worse for now. The patient stated that I am swelling, my feet look swollen, my fingers look swollen. It's all over my body and I mean its breaking me up. It's extremely bad for me (2021). For treatment the patient stated, she want s to meet her doctor on 21Jun2021 to figure out and she stated her doctor will advise to take X-rays to look at the joints. The patient underwent lab tests and procedures which included ANA: positive (my ANA came back positive, but it was at 140 which is not positive and everything else appears to be normal), Epstein Barr virus: inactive (I have inactive virus it was dead virus now), SED rate: elevated. There was investigation assessment. The outcome of event Joint pain was not recovered and unknown for other events. Information on the lot/batch number has been requested.
42 2021-06-17 lymph node swelling Swollen lymph node of armpit of the arm that was injected. It was injected higher on the arm (more o... Read more
Swollen lymph node of armpit of the arm that was injected. It was injected higher on the arm (more on the shoulder) than the 1st dose. The symptom went away after a week. I just noticed it was not a commonly reported symptom, and I thought I should add this information. I don't know if higher placement of injection could have contributed to it. This isn't a complaint; I am just doing my part of contributing the data to compile on the drug
42 2021-06-17 lymph node swelling I have swollen lymph nodes as of noon yesterday. They are only along the left side of my body. The l... Read more
I have swollen lymph nodes as of noon yesterday. They are only along the left side of my body. The locations of the swollen lymph nodes are above my collar bone, arm pit, and groin.
42 2021-06-21 peripheral swelling I woke up in middle of the night to go to the restroom I had pain in my arm and noticed I had a lump... Read more
I woke up in middle of the night to go to the restroom I had pain in my arm and noticed I had a lump the size of a golf ball. I saw rash on my areola going towards my armpit. The lump lasted about 2 weeks and the rash resolved in about 24 hours. I had my last period April 27th, I am currently 2 months past due with my menstrual cycle. My PCP ordered blood work and I've had two ultrasounds done to try and see what I haven't had a menstrual cycle. I also have pain in my lower right abdomen, I've had a test done to check my appendix, but they are fine.
42 2021-06-21 swelling Headache, nausea, vomiting, chills, confusion. Lasted 6 hours. Headache lasted two weeks. Swelli... Read more
Headache, nausea, vomiting, chills, confusion. Lasted 6 hours. Headache lasted two weeks. Swelling around spine, neck, shoulders, is still on-going but getting better. I had loss of bowl control for a day. Headaches severe. Trouble sleeping still. Arm still sore.
42 2021-06-22 lymph node swelling Asthma, fevers, high blood pressure, lymphnodes in armpits and nipples ruptured resulting in dischar... Read more
Asthma, fevers, high blood pressure, lymphnodes in armpits and nipples ruptured resulting in discharge at nipples
42 2021-06-23 peripheral swelling NIGHT PHARMACIST WAS CALLED AT APPROXIMATELY 9:04PM BY PATIENT STATING "SEVERE NUMBNESS, FINGERS WER... Read more
NIGHT PHARMACIST WAS CALLED AT APPROXIMATELY 9:04PM BY PATIENT STATING "SEVERE NUMBNESS, FINGERS WERE BLACK AND PURPLE AND SWOLLEN". Pharmacist advised patient to go to ER to seek medical attention right away and to call pharmacy at their earliest convenience. Pharmacist left message for patient 6/19/21 as follow up, patient did not call back. At time of this report, have not heard from patient.
42 2021-06-24 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: ANXIETY-Medium, Additional Details: WE CALLED 911, paramedics came and her oxygen, heart rate, bpwas fine. pt was given option of going to hospital, but she did not want to go.
42 2021-06-24 swelling Swelling in my chest on the left side with pain; Swelling in my chest on the left side with pain; at... Read more
Swelling in my chest on the left side with pain; Swelling in my chest on the left side with pain; at times I feel I can't breathe well; tingling in my left arm,; slight fever; headache; chills; This is a Spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE) via an unspecified route of administration on the left arm on 13Jun2021 at 01:45 PM (Lot number: EW0196) at the age of 42-year-old as single dose for COVID-19 immunization. Medication history was yes. Past drug event was none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. known allergies was none. Concomitant medication was not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 23May2021 at 12:00 PM (Lot number: EW0187) at the age of 42-year-old as single dose for COVID-19 immunization. On 13Jun2021 at 02:30 PM, the patient experienced swelling in chest on the left side with pain, at times the patient feel can't breath well, tingling in left arm, slight fever, headache and chills. No treatment was received. The outcome of events was not recovered.
42 2021-06-29 lymph node swelling Swollen lymph node,; Pain in whole arm and underarm; pain in whole arm and underarm; This is a spont... Read more
Swollen lymph node,; Pain in whole arm and underarm; pain in whole arm and underarm; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 17Mar2021 at 23:30 as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medication included vitamins (MANUFACTURER UNKNOWN) for an unknown indication. The patient previously received flu vaccine [MANUFACTURER UNKNOWN] in the left arm on 12Oct2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient had not tested for COVID-19. The patient experienced swollen lymph node and pain in whole arm and underarm, on 18Mar2021 at 08:00. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of swollen lymph node and pain in whole arm and underarm was reported as recovering at the time of this report. Information about lot/batch number cannot be obtained. No further information expected
42 2021-06-29 lymph node swelling Swollen lymph nodes in armpit of arm that received vaccine; This is a spontaneous report from a cont... Read more
Swollen lymph nodes in armpit of arm that received vaccine; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727), via an unspecified route of administration in the left arm on 20Mar2021 at 12:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse with heart murmur. The patient did not take any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 21Mar2021 at 16:00, the patient experienced swollen lymph nodes in armpit of arm that received the vaccine. The patient underwent lab test and procedures which included PCR nasal swab in Sep2020 and tested negative. The patient did not receive any treatment for swollen lymph nodes. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the event swollen lymph nodes was recovering at the time of this report. No follow-up attempts are possible. No further information is expected.
42 2021-06-29 swelling face 3 days after vaccine, burning sensation of the tongue, 6 days after face swelling/Lower half of my f... Read more
3 days after vaccine, burning sensation of the tongue, 6 days after face swelling/Lower half of my face is swollen; my eyelids were swollen; My forehead and burning sensation is all over my mouth; 3 days after vaccine, burning sensation of the tongue, 6 days after face swelling; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Apr2021 14:00 (Batch/Lot Number: EW0153) as dose 1, single (age at vaccination 42-year-old) for covid-19 immunisation. Medical history included R arthritis and Migraines from an unknown date to ongoing. The patient previously took Aimovig for taken for migraines on 21Mar2021. Concomitant medication included NABUMETONE taken for an unspecified indication; HYDROXYCHLOROQUINE taken for arthritis from an unspecified start date and ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No known allergies. The patient was not pregnant at the time of vaccination. On20Apr2021 14:00, patient experienced 3 days after vaccine, burning sensation of the tongue, 6 days after face swelling while on 23Apr2021 14:00, patient experienced 6 days after face swelling/Lower half of my face is swollen, my forehead and burning sensation is all over my mouth and my eyelids were swollen. Patient received a burning sensation on her tongue that was three days after that vaccine, six days after that vaccine she woke up and lower half of her face was swollen, her eyelids were swollen, her forehead and burning sensation was all over my mouth. Her first dose of the vaccine was 17Apr2021 and the first symptom, the burning sensation on her tongue she got three days after which was 20Apr2021, from then it just started getting worse and worse on 23Apr she just woke up with her face all swollen. (Year not clarified. Hence, not checked in tab.) Consumer stated, she took Benadryl. It seems to help with the swelling but when she woke up on Tuesday the 27Apr2021 her face was swollen again and when she started taking Benadryl it didn't help. Her face was so swollen, Benadryl doesn't help. Consumer confirmed that it was the Pfizer COVID 19 Vaccine. Consumer stated, patient took Hydroxychloroquine for her Arthritis and she took Aimovig shot for her Migraine. Hydroxychloroquine was 200 mg tablet, 1 tab by mouth daily Monday to Friday and then one tablet by mouth twice daily on Saturday and Sunday. Aimovig 140 mg once a month shot but she hasn't had that since. Last time she the shot on 21Mar2021 and she was, so she was due to take it a week ago, but she didn't because she started getting allergic reaction from the vaccine. So, she doesn't want to take another shot and have other reactions. This month she did not take it. (Further not clarified. Hence, not captured in tab.) she had blood work done for her doctor, her rheumatology doctor and she had blood work done to see if she was perimenopausal (Name not specified. Hence, not captured in tab) and that came back negative. Her rheumatology appointment was on 06Apr2021, that's when she did the testing as well blood test. Results of the test was all normal she was little bit lower on Platelet count but nothing that doctor seems to be worried about. The outcome of the events forehead and burning sensation is all over my mouth, my eyelids were swollen was unknown and other events were not recovered. Follow-up attempts completed. No further information expected.
42 2021-06-30 oral herpes, peripheral swelling I had joint pain, aches, and fatigue. I started to get a severe headache which was a migraine after ... Read more
I had joint pain, aches, and fatigue. I started to get a severe headache which was a migraine after I went to the Emergency Room. My arm started to swell, and I received neuropathy. I also had a herpes cold sore on my top lip and I received medication for that.
42 2021-06-30 peripheral swelling Toes tingling on left foot less than 24 hours after vaccine. 3days later itching between toes on le... Read more
Toes tingling on left foot less than 24 hours after vaccine. 3days later itching between toes on left foot. Within one week had fungal infection between toes on left foot and extreme redness, swelling, and pain on bottom of both feet. At same time, came down with ?covid tongue?- coating and sores on tongue. This went away about 10 days later but feet are still an issue a month later.
42 2021-07-02 lymph node pain congestion intermittently through the night; Headcahe; Earache; Nausea; Lymph node pain; General bod... Read more
congestion intermittently through the night; Headcahe; Earache; Nausea; Lymph node pain; General body pain; Pain from injection site; Joint pain /pain radiating to elbow; Chills; Fever; Cough; hard time breathing; This is a spontaneous report received from a contactable consumer, the patient . A 42-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in an unspecified arm on 22Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. On 22Mar2021, the patient experienced pain from injection site (vaccination site pain) which radiated to elbow, chills and fever, cough developed, hard time breathing (breathing difficulty), congestion intermittently through the night (nasal congestion) headache developed, ear ache developed, nausea, pain in lymph nodes (lymph node pain), body aches (general body pain) and join pain especially along the back (joint pain). No treatment was received for the adverse events. The clinical outcome of the events vaccination site pain, chills, fever, cough, breathing difficulty, headache, ear ache, nausea, nasal congestion lymph node pain, general body pain and joint pain was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
42 2021-07-02 lymph node swelling stomach ache; body aches; Right side of throat pain when swallowing; Extremely swollen lymph nodes i... Read more
stomach ache; body aches; Right side of throat pain when swallowing; Extremely swollen lymph nodes in armpit, above & below collar bone on left side; Fever 102-103 for 3 days; chills; headache; nausea; fatigue; Swollen lymph nodes right side of neck; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 16Mar2021 at 12:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergies. The patient was allergic to penicillin and codeine (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the left arm on 23Feb2021 at 12:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021, the patient had fever 102-103 for 3 days, body aches and chills for 4 days. The patient also experienced headache, nausea, stomach ache for 3 days and fatigue for 7 days. The patient had extremely swollen lymph nodes in armpit, above & below collar bone on left side for 7 days and these were still swollen in the above and below collar bone. The patient experienced right side throat pain when swallowing for 3 days which was still painful. The patient had swollen lymph nodes on right side of neck for 3 days which were still swollen. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events fever, headache, nausea, stomach ache, body aches, chills, fatigue, swollen lymph nodes, axillary lymph nodes enlarged and throat pain. The clinical outcomes of the events fever, headache, nausea, stomach ache, body aches, chills, fatigue, swollen lymph nodes, axillary lymph nodes enlarged and throat pain was unknown. No follow-up attempts are needed. No further information is expected.
42 2021-07-02 peripheral swelling Pt called on 07/03/2021 to report pain/swelling in the right arm. No rashes or discoloration and no ... Read more
Pt called on 07/03/2021 to report pain/swelling in the right arm. No rashes or discoloration and no restriction on the movement. Pt described pain going through right armpit to right breast Pt will observe for few more days and seek doctor's advise if needed.
42 2021-07-05 swelling face The night of 1st dose (on left arm), I had chills and fever, and my eye sockets felt some deep press... Read more
The night of 1st dose (on left arm), I had chills and fever, and my eye sockets felt some deep pressures when I closed my eyes and tried to move my eyes up and down. Left arm was very sore. Two days later, I woke up with my whole face feeling "tight", looked at the mirror, it's swelling. I saw two "red bumps" on my left eyelid and one red bump on my right-side upper nose (near my right eye). In the afternoon, the bumps on my eyelid became itchy and turned into a reddish/pinkish patch, my left-side eyelid became swollen (the single bump near my right eye was gone). At the same time I notice my left-side upper lip was a bit swollen too. The following day afternoon, my right-side eyelid started a reddish/pinkish patch, and it became swollen too. Both of my eyelids are swollen at the moment- it's the 6th day after my 1st dose, and the 3rd day being swollen for my left eyelid and 2nd day for my right eyelid.
42 2021-07-06 lymph node swelling Swollen lymph nodes in neck (both left and right sides) and at right collar bone. Warm compresses an... Read more
Swollen lymph nodes in neck (both left and right sides) and at right collar bone. Warm compresses and massage. Alternating ibuprofen and Tylenol to ease discomfort.
42 2021-07-07 swelling face Patient called today and informed us that the day after she got her first dose of the Pfizer vaccine... Read more
Patient called today and informed us that the day after she got her first dose of the Pfizer vaccine, she woke up and had facial swelling. She went to the hospital and was treated for the reaction and the doctor recommended for her not to get her second dose of the vaccine. Patient felt fine afterwards.
42 2021-07-07 white blood cell count increased Noted that symptoms began about 1 week after second dose of Pfizer COVID-19 vaccine. Symptoms initia... Read more
Noted that symptoms began about 1 week after second dose of Pfizer COVID-19 vaccine. Symptoms initially started with moderate hot flashes, constant migraine headache. Symptoms progressed to substernal chest pain that is somewhat positional however now has become constant. Pain radiation to right neck. Noticed decreased exercise tolerance such as walking moderate distances made her extremely sweaty. Went to ER on 6/29/21 after first being seen by primary doctor and found of ST depressions and was found abnormal EKG, normal D-dimer, troponin negative, placed in the rapid cardiology follow-up list. Went to ER on 7/4/2021 due to ongoing symptoms that are sharp, substernal, constant, worsened with bending over, intermittently radiating to right neck. Family history of MIs in the 40s. Patient does not smoke. Not a diabetic. New onset of right crampy groin pain and right calf pain. No history of DVT personally. Diagnosis in ER: Given the patient's clinical history, character and duration of symptoms, I am more suspicious for pericarditic equivalent rather than primary ACS. Recommend ibuprofen 400 mg 3 times a day. X10 days. We will arrange outpatient echocardiogram Once all symptoms are resolved may be in 3 to 4 weeks consider stress testing Will arrange follow-up in the office within a week DC planning from cardiac standpoint.
42 2021-07-08 lymph node pain Nauseous; Muscle pain; No appetite; Most painful on shot arm; Crash naps 3 times on first day; Visio... Read more
Nauseous; Muscle pain; No appetite; Most painful on shot arm; Crash naps 3 times on first day; Vision disruption; Chest pain; Dizzy; Pain in lymph under armpitsand neck; Exhaustion all day; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch number: ER 2613), via an unspecified route of administration, administered in arm left on 23Mar2021 at 10:00 as a single dose (at the age of vaccination 42-years) for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch number: ER 6205), via an unspecified route of administration, administered at left arm on 02Mar2021 at 10:00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was allergic to keflex, bractrum. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent dose of COVID-19 vaccine in a clinic. On 23Mar2021, the patient experienced vision disruption, dizzy non-stop for first 4 hrs that impacted vision and stability, pain in lymph under armpits and neck, most painful on shot arm, crash naps 3 times on first day, exhaustion all day, no appetite, nauseous. muscle pain and chest pain for 3 days. The patient did not receive any therapeutic measures for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events most painful on shot arm, dizzy, crash naps 3 times on first day, exhaustion, nauseous, pain in lymph, vision disruption and no appetite were recovering. The clinical outcome of the events muscle pain and chest pain was recovered on unknown date. No follow-up attempts are possible. No further information is expected.
42 2021-07-08 lymph node swelling Sore left arm; Fatigue; Swollen lymph nodes under left arm and along left clavicle; This is a sponta... Read more
Sore left arm; Fatigue; Swollen lymph nodes under left arm and along left clavicle; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199) via an unspecified route of administration on left arm on 23Mar2021 at 10:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history, however, she was allergic to milk and gluten sensitivity. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN5318) via an unspecified route of administration on the left arm on 02Mar2021 at 09:45 (at the age of 42-year-old), as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021 at 10:30 The patient experienced sore in the left ram, fatigue and swollen lymph nodes under left arm and along left clavicle on. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore in the left ram, fatigue and swollen lymph nodes were resolving at the time of reporting. No follow-up attempts are needed. No further information expected.
42 2021-07-08 swelling face, anaphylactic shock Hives swollen face and got anaphylactic shock bith both 1 and 2 series of pfizer vaccine Also got p... Read more
Hives swollen face and got anaphylactic shock bith both 1 and 2 series of pfizer vaccine Also got pericarditis was treated with predisone and benadryl also with an ansthma inhaler and got referred to see a cardiologist to check my heart because EKG showed possible LEft Atrial Enlargement but tests showed no LAE it is pericarditis
42 2021-07-09 fluid retention The first night I had a mild fever and Severe headache. Then my neck was stiff the next day and my b... Read more
The first night I had a mild fever and Severe headache. Then my neck was stiff the next day and my back was sore in addition to the headache. I had nausea and chills. I also had stomach upset with diarrhea. Then over the next few days the pain stayed in my back and I felt like I had the flu. By the 5th day, I felt like I had pain in my bones in my legs. The pain was bad enough that I couldn't sleep at night. I was taking ibuprofen several times a day and waking up in the middle of the night to take more ibuprofen. After a full two weeks of leg pain my doctor sent me to have an ultrasound of my veins in my legs because of the pain. I also had a little swelling in my left ankle. The ultrasound came back ok. The pain has subsided for the most part, but I still have pain in my left ankle. Yesterday I sat with my foot up most of the afternoon because of the pain. And it kept me up last night. I took Tylenol before bed and again at 5:00 AM because I couldn't sleep from my ankle aching. This morning when I got up, my left ankle is swollen and still aching. I have occasional pain in my legs, and left arm. But the ankle pain in my left ankle and swelling for no reason are starting to concern me. It's now been a month since my second dose of the vaccine and I'm walking with a limp because my ankle is so sore. There appears to be a bit of fluid on my ankle, or swelling. And I haven't done anything that would cause this. The pain is exactly the same as it started, its an ache in the bones and joints.
42 2021-07-10 lymph node swelling Achy; Nausea; Slight fever (barely 99); Chills; Exhaustion; swollen lymph nodes of neck; This is a ... Read more
Achy; Nausea; Slight fever (barely 99); Chills; Exhaustion; swollen lymph nodes of neck; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER 8730) via an unspecified route of administration in the left arm on 25March2021 at 13:45 as a single dose for COVID-19 immunisation. Patient medical history was kidney stones, long COVID-19 infection. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN), mirtazapine (MANUFACTURER UNKNOWN), vitamins and aluminium hydroxide, magnesium trisilicate, sodium alginate (PEPCID) received within 2 weeks of vaccination. The patient was allergic to dairy and sulfa based antibiotics. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, it was unknown whether patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27March2021, the patient experienced nausea, slight fever of 99 degree Celsius, chills, exhaustion, swollen lymph nodes in neck, ache. No therapeutic measures were taken for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events nausea, fever, chills, exhaustion, swollen lymph nodes in neck, ache were unknown at the time of reporting. No follow-up attempts are possible. No further information is expected.
42 2021-07-12 lymph node swelling Body ache; Fatigue; Swollen lymph nodes under left arm; Chills; low grade fever; bruise on left arm ... Read more
Body ache; Fatigue; Swollen lymph nodes under left arm; Chills; low grade fever; bruise on left arm just under injectionsite.; This is a spontaneous report from a contactable healthcare professional, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 25Mar2021 at 10:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to sulfa (sulfonamide drugs). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included norethisterone acetate, ethinylestradiol, ferrous fumarate (BLISOVI 24FE) taken for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 04Mar2021 at 10:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 26Mar2021, the patient experienced chills with low-grade fever after 14 hours of vaccination. On 27Mar2021 after 18 hours of vaccination, the patient experienced fatigue and body ache, a swollen lymph node under the left clavicle. On an unknown day in Mar2021, the patient had a bruise on the left arm, just under the injection site which was present about 20 hours after vaccination. Therapeutic measures were taken as a result of chills with low-grade fever, fatigue, body aches, swollen lymph nodes, bruise on the left arm and included treatment with ADVIL. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events low-grade fever was resolved on 27Mar2021 after a duration of 6 hours and bruises was recovered on an unknown day in Mar2021; chills was recovering; while the events of fatigue, body ache, swollen lymph nodes were not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
42 2021-07-14 lymph node swelling Following the COVID vaccine I experienced the following symptoms. The neurologic symptoms progresse... Read more
Following the COVID vaccine I experienced the following symptoms. The neurologic symptoms progressed over 3 months following the vaccination. Difficultly following instructions Difficultly following conversations Difficultly with basic math Poor Memory Difficultly making complex decisions Word finding Difficultly Spelling Concentration Fatigue Depression Difficultly swallowing Coughing after eating Difficultly hearing Difficultly explaining things Left arm and leg tingling 3/20/2021 Right arm tingling 4/5/2021 Left leg numbness 4/5/2021 Difficultly with reading comprehension Tremors Pain in my right eye with movement Twitching 1st vaccine Dec 23rd - fatigue - Sore throat - Muscle aches - Ear pain - Headache 2nd vaccine Jan 13th - Fever 101. - Extreme fatigue - Sore throat - Muscle aches - Ear pain - Headache - Slept for 36 hours PCP, 3/11/2021 Labs showed, Vitamin B12 low normal Folate low normal Vitamin D low normal Started on: B12 1000 mcg Vit D5000 Folic acid 1 mg MRI April 1st showed right mild mastoid effusion Lab work, vitamin B12 and folate increase Hearing test Scheduled Wednesday 5/26/2021 Sudden lump behind right ear Itchy Feeling of fullness in ear Dull throbbing Ear drum significantly red Tenderness in jaw Tenderness in neck Tenderness behind ear Tenderness base of skull on right side Decreased sensation in right side of face Heart palpitations Wednesday night to Thursday morning PCP 5/28 Ultrasound of ear, shows enlarged lymph nodes Started on: Augmentin antibiotic The ear pain and word finding continue.
42 2021-07-15 peripheral swelling Swollen arm, Redness at injection site Heart palpitations Fatigue Muscle soreness Loss of appetite H... Read more
Swollen arm, Redness at injection site Heart palpitations Fatigue Muscle soreness Loss of appetite Headache Chills
42 2021-07-16 lymph node swelling -Severe pain in joints and tendons in both arms (started on left side (injection side) then migrated... Read more
-Severe pain in joints and tendons in both arms (started on left side (injection side) then migrated to the right side as well and back pain -swollen lymph nodes in the left armpit lymph node increased to 2-3?. Both lymph nodes in throat (left and right side) significantly increased 1-2? (7/15/21 through today 7/17/21) -mild fever highest recorded 102F (11pm 7/14 through 7/16/21) -major sweat spells (7/15-7/17/21) -tinted -very light pink urine twice. First time 7/15/21, second 7/16/21. Seems like blood in Urine noticeable on toilet paper, odor similar to blood/metallic -throbbing pain in my lower right back not constant on 7/16/21, today currently not experiencing this -major body aches and chills 7/15/21-today -inside of mouth on the inside of my lips/cheeks tender and metallic taste -headache but today 7/17/21 major migraine -tired and low energy all days -nausea on/off all days -major
42 2021-07-17 lymph node swelling, peripheral swelling Was like something sitting on her chest holding her throat closed; Chest tightness; Arm swelling up;... Read more
Was like something sitting on her chest holding her throat closed; Chest tightness; Arm swelling up; Arm pain/Sore arm; Lymph nodes very swollen; Arm pain at injection site: 5 to 6 hours after it was pretty intense; Sounded hoarse; Joint pain; was like something sitting on her chest holding her throat closed; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0202, Expiry date was not reported) dose 2 via an unspecified route of administration on 28Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient's medical history (including any illness at time of vaccination) and family medical history relevant to adverse events were none. The patient did not take concomitant medications (No other products). Patient previously had first dose of BNT162b2 (Batch/lot number: EW0185) at left arm around shoulder on 04Jun2021 (at age of 42-years old) for covid-19 immunisation and experienced fatigue which started 8 hours after the first dose and treatment - took acetaminophen, Body aches which was started - 8 hours on 04Jun2021 to 09Jun2021 and she just had a sore arm as well that was super mild at the injection site. No adverse evets following prior vaccinations. No prior vaccinations (within 4 weeks. No additional vaccines administered on same date of the pfizer suspect. On 28June2021 she was okay right after the second shot for the first 5 to 6 hours, she felt normal and only had arm pain. They did inject it in the same arm. Arm pain at injection site: 5 to 6 hours after it was pretty intense, she did well with the first one. Arm swelling up: It was not mild swelling it was the size of a large grapefruit. Treatment, they advised her to put ice on it and to take ibuprofen. She looked in the mirror and her lymph nodes very swollen and she sounded hoarse and had chest tightness. She experienced it was like something sitting on her chest holding her throat closed. Lymph nodes very swollen was started at bedtime 8 or 9 pm 28Jun2021 and treatment was she went to urgent care and they sent her to the hospital. Chest tightness was started at 10pm on 28Jun2021. She had pain and tightness. Treatment was she went to the urgent care and they sent her to the hospital. She was really concerned about the lymph node swelling, joint pain, and chest and asked them what treatment there was and what could she do to feel better. The urgent care suggested going to the Emergency Room. There was no relevant tests. The outcome of the events chest tightness and chest pain was recovering, arm swelling up and lymph nodes very swollen are not recovered and rest of all events was unknown.
42 2021-07-17 lymph node swelling level 9 out of 10 pain in spine making it difficult to walk; 9 out of 10 pain in spine making it dif... Read more
level 9 out of 10 pain in spine making it difficult to walk; 9 out of 10 pain in spine making it difficult to walk lasting 2 weeks; pain in arm; burning in stomach; difficulty swallowing; fever greater than 103,; Swollen lymph node around neck, difficulty swallowing, burning in stomach, fever greater than 103, level 9 out of 10 pain in spine making it difficult to walk lasting 2 weeks and disappeared, pain in; This is a spontaneous report from a contactable other health care professional. A 42-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6198, Expiration date: unknown), via intramuscular, administered in left arm on 03Mar2021 at 10:30 am (at the age of 42-year-old) as single dose for COVID-19 immunization in hospital. The patient medical history includes Post stage 4 breast cancer, autoimmune disease, many surgeries from breast cancer 10 plus years ago, Laminectomy L4-5 >10 years. Allergies to medications, food or other products was reported as yes, but details are not reported. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered in right arm on 10Feb2021 10:30 as single dose for COVID-19 immunisation. Patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. On 03Mar2021 16:00, the patient experienced Swollen lymph node around neck, difficulty swallowing, burning in stomach, fever greater than 103, level 9 out of 10 pain in spine making it difficult to walk lasting 2 weeks and disappeared, pain in arm less than 48 hours. Events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was given with Tordol shot and medications for severe spams of spine and back. The events assessed as serious. The patient underwent lab tests and procedures which included body temperature (pyrexia): greater than 103 on 03Mar2021. The outcome of all events was resolved.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events of Gait disturbance, Spinal pain and Pain in arm cannot be totally excluded/assessed. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
42 2021-07-17 lymph node swelling fever; severe headache; nausea; abdominal pain; swollen lymph nodes; injection site pain; full body ... Read more
fever; severe headache; nausea; abdominal pain; swollen lymph nodes; injection site pain; full body ache; chills; diarrhea; decreased appetite; muscle and joint pain; muscle and joint pain; This is a spontaneous report from a contactable consumer(patient). A 42-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ew0172 expiration date: unknown) via an unspecified route of administration, in the left arm 04May2021 04:45 PM (at the age of 42 years) as dose 2, single for covid-19 immunisation. Medical history included, arrhythmia, hypothyroid and undifferentiated connective tissue disorder all from an unknown date and unknown if ongoing. Known allergies peanuts and tree nuts were reported. Prior to vaccination patient was not diagnosed with COVID-19 and was not tested for it since the vaccination. Concomitant medications included pregabalin (LYRICA), levothyroxine, flecainide, drospirenone, ethinylestradiol (OCELLA), and omeprazole (OMEPRAZ) all taken for an unspecified indication. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: er8731 expiration date: unknown) via an unspecified route of administration in the left arm on 13Apr2021 at 05:15 PM as dose 1, single for COVID-19 immunization. The patient did not receive any vaccines within four weeks prior to the vaccination. On 04May2021 at 17:15, the patient experienced fever, severe headache, nausea, abdominal pain, swollen lymph nodes, injection site pain, full body ache, chills, diarrhea, decreased appetite, muscle and joint pain. The patient had received treatment for event with tylenol, ibuprofen and ondansetron. The outcome of events was reported as not resolved. No follow-up attempts were possible; no further information expected
42 2021-07-17 peripheral swelling dizziness; shortness of breath; her throat is tight; Sore Arm; Swollen; Warm/Hot; Painful; has a sor... Read more
dizziness; shortness of breath; her throat is tight; Sore Arm; Swollen; Warm/Hot; Painful; has a sore arm with swelling and warmth; has a sore arm with swelling and warmth; Sore Arm; Swollen; Warm/Hot; Painful; This is a spontaneous report from a contactable consumer reporting for herself. A 42-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 27May2021 10:00 (Batch/Lot number was not reported) as single dose (age at vaccination 42 years) for covid-19 immunization. Medical history included covid-19 from Jan2021 to Jan2021. The patient did not administer additional vaccines on same date of the Pfizer Suspect. Family Medical History Relevant to adverse events (AEs), AEs following prior vaccinations and Prior Vaccinations (within 4 weeks) was reported as none. There were no concomitant medications. It was reported that, got 1st dose and on 27May2021 at 19:00. she has dizziness and Shortness of Breath feels like she was kind of holding her breath; feels breathing pressure. It feels like when she has a food allergy. Her throat was tight. She has a sore arm with swelling and warmth. Also reported as Sore Arm; Swollen; Warm/Hot; Painful. Patient stated, she was concerned, and she knows she has to report it, but most people have common things like arm pain and fever. Caller asking if this is a normal reaction of if she should be concerned, she has had Covid before and this feels worse. Caller states she was also concerned because her kids were getting their shots next week and she doesn't want them to feel like this. Caller states when she feels breathing pressure, she starts freaking out. Treatment: None. Caller states she opened the windows and laid back to try and open the airway. Caller states she doesn't know if she should go to the hospital or not. Caller states she was searching for information, but it didn't seem to be a common side effect. Caller states is feels like she is kind of holding her breath. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jan2021. The patient did not visit Emergency Room for AE. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.
42 2021-07-17 swelling Swollen painful armpit left side; Swollen painful armpit left side; This is a spontaneous report fro... Read more
Swollen painful armpit left side; Swollen painful armpit left side; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 04Mar2021 at 12:00 (at the age of 42-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 25Mar2021 at 09:30 (at the age of 42-years-old); each as a single dose for COVID-19 immunisation. Medical history included migraine. The patient previously took CECLOR and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 05Mar2021 at 12:00, the patient experienced swollen painful armpit on the left side. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The clinical outcome of swollen painful armpit on the left side was resolving at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
42 2021-07-18 swelling sharp pain in groan area . lump appeared in left clavicle
42 2021-07-19 lymph node swelling swollen lymph node on collarbone area; collarbone on the right side started hurting; This is a spont... Read more
swollen lymph node on collarbone area; collarbone on the right side started hurting; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the right arm on 27Mar2021 at 11:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levocetirizine dihydrochloride (XYZAL) and ethinylestradiol, norgestimate (TRI-SPRINTEC) all from an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the right arm on 06Mar2021 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. The patient did not have a history of allergies to medications, food or other products. The patient had not received other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 23:00, the patient experienced collarbone hurting on the right side and after 2 days on 29Mar2021, the patient had a swollen lymph node on collarbone area, it was currently still swollen. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcomes for the events collarbone hurting and swollen lymph nodes on collarbone area was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
42 2021-07-20 peripheral swelling, swelling, lymph node swelling Sine 06/12/2021, my body has been covered in swollen, red, itchy hives. My left arm swelled for seve... Read more
Sine 06/12/2021, my body has been covered in swollen, red, itchy hives. My left arm swelled for several days and was bruised, itchy, and very painful. The reaction on my arm subsided after a week, but the full body hives, sore throat, headache, joint pain, chest pain, and exhaustion have continued daily since. I have had swollen lymph nodes and a spot appeared on my mammogram that I had to have rechecked.
42 2021-07-21 peripheral swelling Left arm sore; scratchy/sore throat; Fatigue; Body aches; This is a spontaneous report from a contac... Read more
Left arm sore; scratchy/sore throat; Fatigue; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 15:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The concomitant medications were not taken by the patient within two weeks prior to COVID-19 vaccine. The past drug history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. On 01Apr2021 at 15:15, the patient experienced left sore arm/swollen arm, scratchy/sore throat, fatigue and body aches. The patient did not receive any treatment for the reported events. The clinical outcome of the events swollen arm, sore throat, fatigue and body aches were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
42 2021-07-22 peripheral swelling About 10 days after my first dose of the Pfizer COVID-19 vaccine I started to develop what was later... Read more
About 10 days after my first dose of the Pfizer COVID-19 vaccine I started to develop what was later determined to be chillblains. I have never experienced this before. It started out feeling like a splinter was deep in a finger on my right hand. A pinpoint red dot then appeared and over days it grew in size until it looked like my finger had a red marker stain on it. This continued to progress on all digits of my right hand and then began on the left hand as well. My symptoms were at their worst on Feb 4th. At this point they were swollen, painful, red and purplish, and itchy. As the inflammation worked its way to the surface it ended with a superficial callous-like sore. Symptoms have not returned.
42 2021-07-22 swelling face 1. Hives 2. Facial swelling 3. Wheezing 4. Legs warm to the touch All occurring approximately 2 ho... Read more
1. Hives 2. Facial swelling 3. Wheezing 4. Legs warm to the touch All occurring approximately 2 hours post injection and are still present 23 hours later.
42 2021-07-26 peripheral swelling Pfizer-BioNTech COVID-19 Vaccine: patient presented to emergency department 22 days after first immu... Read more
Pfizer-BioNTech COVID-19 Vaccine: patient presented to emergency department 22 days after first immunization and one day after second immunization with right leg swelling for three days. Vital signs within normal ranges except heart rate 107 beats per minute. No cough or shortness of breath. Reports family history of deep vein thrombosis (DVT) and pulmonary embolism. Diagnosed with right leg DVT, prescribed anticoagulation, referred to outpatient follow-up, and discharged to home.
42 2021-07-26 peripheral swelling At 4:00pm on 4/28/2021, I woke up paralyzed on one side (left side of body). Stayed in bed and wore ... Read more
At 4:00pm on 4/28/2021, I woke up paralyzed on one side (left side of body). Stayed in bed and wore off after 1 hour. After 1 hour, my left arm considerably stayed in pain. I took Tylenol for the pain to subside. Arm was swollen. Swelling went down. I went to the doctor and there is no swelling. Pain is present at site of injection, limit of mobility. Lifting a box with a certain amount of weight, pain comes on strong the next day at the injection site.
42 2021-07-27 peripheral swelling right arm swollen; itchy; fever; bruised; This is a spontaneous report from a contactable consumer, ... Read more
right arm swollen; itchy; fever; bruised; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm right on 02Apr2021 at 10:00 (at the age of 42-year-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm right on an unknown date, both as a single dose for COVID-19 immunisation. Medical history included stroke, blood pressure high and high cholesterol. Concomitant medications included too many unspecified drugs (as reported). The patient previously took Peroxide and adhesive. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 the patient experienced two spots covering the top right arm swollen, itchy, fever and bruised. They looked like a bullseye as reported. The clinical outcome of the events arm swollen, itchy, fever and bruised were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
42 2021-07-27 swelling, peripheral swelling, neck mass I took the shot in left arm, it's swollen and it hurts; have swelling in my arm and in neck; I took ... Read more
I took the shot in left arm, it's swollen and it hurts; have swelling in my arm and in neck; I took the shot in left arm, it's swollen and it hurts; have swelling in my arm and in neck; I took the shot in left arm, it's swollen and it hurts; have swelling in my arm and in neck; I took the shot in left arm, it's swollen and it hurts; have swelling in my arm and in neck; I feel like a little round, like a cherry lump in my neck; Headache; Slight fever 99.9; I couldn't move my arm was swollen and neck hurt and my arm; I couldn't move my arm was swollen and neck hurt and my arm; I couldn't move my arm was swollen and neck hurt and my arm; My eyes were so heavy; Joint pain, I still have the pain in my shoulder and the lump; I still have the pain in my shoulder and the lump; This is a spontaneous report from a contactable Nurse reporting for herself. A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot: ENCO208, patient was unsure, hence not captured in tab; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 31Mar2021 (at the age of 42-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included high blood pressure (hypertension) from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for hypertension, vitamins nos (VITAMINS NOS) taken for an unspecified indication, start and stop date were not reported. Patient stated, she was just have been taking hydrochlorothiazide and vitamins. The patient previously took first dose BNT162B2 on unspecified date for covid-19 immunisation. Patient stated first dose lot number as "EN I do not know if it is a O203 or it is LO." Any recent vaccines for any other conditions, any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported; any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine; history of any previous allergies to specific products or any conditions indicative of an allergy included none. The patient started experiencing after she took the shot in left arm, it's swollen and it hurts; had swelling in arm and in neck, felt like a little round, like a cherry lump in neck, headache, slight fever 99.9, couldn't move arm was swollen and neck hurt and arm, eyes were so heavy, joint pain, still had the pain in shoulder and the lump on an unspecified date. It was reported that patient received second shot of COVID Vaccine on Sunday and started experiencing like a lump in (incomplete sentence), took the shot in left arm, it's swollen and it hurts, and this is the third day and I have swelling in my arm and in neck. When paraphrased the above concern, patient stated to feel like a little round, like a cherry lump in neck. Patient was provided with the number of Pfizer Medical information Department. With respect to causality, patient stated, yes, for the second shot she did a mammogram, there was nothing there. Laboratory test included just the mammogram and the results were normal. Patient stated, the first day, didn't have any symptoms, until next morning, she had a headache, slight fever 99.9. Had lot of joint pain, couldn't move her arm was swollen and neck hurt and her arm. Patient reported to got up like 6 AM and that's all she felt she had a fever, headache, eyes were so heavy and the day before this report she got off, she was okay but still have the pain in shoulder and the lump. The patient did not require medical intervention. And stated that she did not go to the ER, as they told her that would be the side effect, what she did not know was that she would have a swollen area in her neck and arm. The patient was not hospitalized or admitted to an intensive care unit or required the initiation of new medication or other treatment or procedure. Laboratory tests or diagnostic studies were not performed, stated as not that she knew of. Clinical outcome of the events was recovering at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
42 2021-07-27 swelling generalized swelling, joint pain, paresthesias, neg labwork
42 2021-07-27 swelling 1-5 minutes after the shot I got a pain on the left arm and I ignored it since I was on the phone an... Read more
1-5 minutes after the shot I got a pain on the left arm and I ignored it since I was on the phone and I had received the vaccine on the right arm. I got to my car after buying something at Walgreens and I felt a pain on my leg but I also ignored it . I got home and since then I have been feeling like something is pinching me mostly on arms, legs, fingers and toes. Once it happened on my finger and it was more intense than usual and I saw my vain popping up and it was a little purple. It went away after a few minutes and today I felt that on my arm and it was also more intense than usual and I also saw my vein popping up and the area showed a big bump . It went away right now (about 7 hours later ) I only have a very tiny bump in that area. I also felt a pain kind of like cramps on my right leg and pain on certain area on my feet and I feel it when I walk . I have felt something in my head also but it feels more like small needles and it is not a headache . I don?t know what to do regarding the second shot and I tried to see a specialist right away but they need the blood tests in order to help me . I will see a doctor on 7/30 and hopefully get the order for the blood tests soon so I can see the specialist. Other than that I have been feeling tired but I understand that this is a normal symptom. I do have pictures if you need them and I can also share information about my blood tests with you and once I see a specialist I can ask him to complete this report. If you have any suggestions please email me since what concerns me is that I believe that this has to do with blood clots and I know that this can turn into a Really bad situation. Thank you
42 2021-07-28 lymph node swelling Of my feet itched like something I have never experienced; rash on my thighs; fatigue; headache; blu... Read more
Of my feet itched like something I have never experienced; rash on my thighs; fatigue; headache; blurry vision; still to this day swollen lymph nodes.; This is a spontaneous report from a contactable consumer.A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 16:45 (Batch/Lot Number: EW0158) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included allergy with Sulfa drugs. Concomitant medication(s) included lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number:ER8736) on 01May2021 administrated in left arm for covid-19 immunization.After second dose, within 5 days , the bottom Of my feet itched like something I have never experienced, rash on my thighs, fatigue, headache, blurry vision, still to this day swollen lymph nodes. Outcome of swollen lymph nodes was not recovered, of others was recovering. Therapeutic measures were taken as a result of all events.
43 2021-01-03 lymph node swelling, lymph node pain Anterior cervical lymphadenopathy on the ipsilateral side of the vaccination. It seemed to begin on ... Read more
Anterior cervical lymphadenopathy on the ipsilateral side of the vaccination. It seemed to begin on the third day but was most pronounced and painful on the fourth day.
43 2021-01-03 lymph node swelling Noticed a little tension to supraclavicular area, then when palpated noticed the swelling
43 2021-01-03 swelling face My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but... Read more
My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but I didnt and took benedryl went to sleep, woke up and I felt a little SOB but more like something was tied around my ribs preventing me from breathing. I saw the cardiologist who believed it to be sinus tackycardia as a result as an AE to vaccine. Felt as if my face and lips were swelling so I took benedry and laid down again and the next morning when I woke up and my face and lips were super swollen. But by the 3rd day the symptoms began to subside a little. By the 24th my HR had balanced out and I only had residual swelling around the eye area.
43 2021-01-04 peripheral swelling, lymph node swelling I had lymphadenopathy in my right armpit for three days post vaccine. I used a heating pad to treat.... Read more
I had lymphadenopathy in my right armpit for three days post vaccine. I used a heating pad to treat. I also developed swelling on my right forearm that was hot to touch with pain. I used a heating pad as well on my right forearm and took Tylenol for two days-it resolved.
43 2021-01-06 anaphylactic reaction anaphylactic reaction 2 hours post vaccine, given 2 rounds of epi in the ED in addition to allergic ... Read more
anaphylactic reaction 2 hours post vaccine, given 2 rounds of epi in the ED in addition to allergic reaction meds, still with rash.
43 2021-01-06 oral herpes 14 hrs after vaccination developed fever 101.4, headache, myalgia and chills. decreased the next da... Read more
14 hrs after vaccination developed fever 101.4, headache, myalgia and chills. decreased the next day but head ache and low grade fever remain.
43 2021-01-07 swelling Fever, Angioedema, SkinRash & Rash Narrative:
43 2021-01-07 swelling Angioedema, HYPERtension & Tachycardia Acute mild allergic reaction //Patient placed in a cardiac mo... Read more
Angioedema, HYPERtension & Tachycardia Acute mild allergic reaction //Patient placed in a cardiac monitor //Given Solu-Medrol as well as Pepcid //No evidence of anaphylaxis, epinephrine is not indicated at this time //No worsening of sx. vs improved. //will DC home with steroids.
43 2021-01-07 lymph node swelling Left arm (site of injection) soreness/pain Left underarm; Swollen lymph nodes; This is a spontaneous... Read more
Left arm (site of injection) soreness/pain Left underarm; Swollen lymph nodes; This is a spontaneous report from a contactable Nurse (patient herself). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142X-31-21), via an unknown route, on 29Dec2020 at 21:30 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was not pregnant. Relevant medical history included hypothyroidism, hypertension and COVID-19 (prior to vaccination). Relevant concomitant medications included amlodipine. The patient was vaccinated at hospital, age at vaccination was 43-year-old. No other vaccine was received in four weeks. On 30Dec2020 at 12:30 the patient developed 'left arm (site of injection) soreness/pain left underarm' and 'swollen lymph nodes'. Post-vaccination COVID test was not performed. The patient was not treated for the events. She was recovering from the events.
43 2021-01-07 lymph node swelling Per patient report: "Received my 2nd dose Jan. 5,2021 @ 1020 noticed pain and tenderness in Left arm... Read more
Per patient report: "Received my 2nd dose Jan. 5,2021 @ 1020 noticed pain and tenderness in Left arm injection site, armpit of the same side and radiating pain across neck and shoulder to right side by the next morning Jan.6. Late afternoon pain increased in left armpit significantly and noticed swelling, warmth and hardness along with stabbing pains in left forearm and hand throughout the night. "
43 2021-01-07 lymph node swelling I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; I began ha... Read more
I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; discomfort 4-5 on a 0-10 scale; I also noted stollen lymph nodes in my neck, throat, and subclavicular areas.; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142) (Brand: Pfizer), via an unspecified route of administration from 31Dec2020 14:30 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant. The facility type vaccine was Nursing Home/Senior Living Facility. Medical history included hypertension, aneurysm of ascending aorta, erbs-duchenne palsy right arm, asthma, seasonal allergies. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), diltiazem (DILTIAZEM SR), sertraline hydrochloride (ZOLOFT). The known allergies included PCN, bananas, passion fruit. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. 12h post vaccine at 01Jan2021 08:30 AM, patient began having muscle and joint aches throughout her body, discomfort 4-5 on a 0-10 scale. She also noted stollen lymph nodes in her neck, throat, and subclavicular areas. Patient didn't receive treatment for the adverse events. The outcome of events was recovered in Jan2021. Patient didn't experience Covid prior vaccination. She took Covid tested post vaccination, covid test type post vaccination Nasal Swab on 02Jan2021, the covid test result negative. The events were reported as non-serious.
43 2021-01-07 swelling One week after receiving the Covid vaccine, pt was seen by telemedicine in our clinic with symptoms ... Read more
One week after receiving the Covid vaccine, pt was seen by telemedicine in our clinic with symptoms of local cellulitis. The area was red, swollen and warm to touch.
43 2021-01-08 lymph node swelling Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, chills alternating with sweats as well, fever co... Read more
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, chills alternating with sweats as well, fever continued for 2 days, also reporting swollen glands Narrative: Symptoms persisted for 48 hours, with some lingering symptoms beyond 48 hours (headache, aches, swollen glands)
43 2021-01-08 lymph node swelling Hives began on hands early morning Wednesday. Friday hives on legs. Saturday both arms, legs, feet h... Read more
Hives began on hands early morning Wednesday. Friday hives on legs. Saturday both arms, legs, feet have hives. Have headache since receiving vaccination. Swollen, painful axillary lymph nodes on side of injection from Monday and still sore today on Saturday.
43 2021-01-08 white blood cell count increased Generalized edema, shortness of breath, change in taste
43 2021-01-09 swelling face Received vaccine on 1/4. Started with hives on 1/6 am. Facial swelling on 1/7. Has been taking Benad... Read more
Received vaccine on 1/4. Started with hives on 1/6 am. Facial swelling on 1/7. Has been taking Benadryl 50 mg at night since 1/6. Facial swelling continues. Hives reduced, but redness continues.
43 2021-01-10 lymph node swelling, lymph node pain Axillary swelling, pain and tenderness in armpit. pain in finger joints.
43 2021-01-10 lymph node swelling injection site armpit/ lymph node swelled and was EXTREMELY palpable and painful... unable to clos... Read more
injection site armpit/ lymph node swelled and was EXTREMELY palpable and painful... unable to close my armpit as of today 1/11/2021, swelling has reduced but still painful
43 2021-01-10 lymph node swelling axillary adenopathy on injection side 48 hrs headache
43 2021-01-10 lymph node swelling Erythema and tenderness with reactive lymph nodes left axillary area The size of erythema is 18x8 cm
43 2021-01-10 lymph node swelling Left axillary lymphadenopathy, fatigue/body aches
43 2021-01-10 swelling Swelling, pain, muscle weakness, redness, heat
43 2021-01-11 anaphylactic reaction, white blood cell count increased first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, the... Read more
first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, then 9 am hives everywhere, trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv fluids were influsing and epi drip started, went to ICU
43 2021-01-11 swelling urticaria angioedema
43 2021-01-11 peripheral swelling Rash Back (L) arm chest pruritic Nausea & vomiting. Swelling (L) arm Exam Rash as above external ves... Read more
Rash Back (L) arm chest pruritic Nausea & vomiting. Swelling (L) arm Exam Rash as above external vesicle Txt corticosteroid, antihistamines
43 2021-01-11 swelling face 1/9/2021 0400-Chills 1/9/2021 1400-leg pain-8 on 0-10scale, overall body aches, fatigue 1/10/2021 07... Read more
1/9/2021 0400-Chills 1/9/2021 1400-leg pain-8 on 0-10scale, overall body aches, fatigue 1/10/2021 0700-Facial swelling, mostly around eyes, forehead, and nose 1/11/2021 0700-Continued facial swelling limited to around eyes only 1/12/2021 0530-Continued facial swelling limited to around left eye only
43 2021-01-12 anaphylactic shock I received my covid vaccine on 12/29/2020 at 4:42pm. In 10 minutes after the shot, I went into anap... Read more
I received my covid vaccine on 12/29/2020 at 4:42pm. In 10 minutes after the shot, I went into anaphylactic shock, I broke out in hives, and my throat was closing
43 2021-01-12 lymph node pain, lymph node swelling Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Supraventricular tachycardia (pt has ... Read more
Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Supraventricular tachycardia (pt has prior hx of this): ambulance to hospital. Pt assessed & released same day. Pt is free from that symptom now. Also experienced painful knot under arm lasting 5 days
43 2021-01-12 lymph node pain, lymph node swelling Fever, mayalgias, fatigue, swollen and sore lymph node under right arm pit
43 2021-01-12 lymph node swelling Swollen lymph nodes, fever, chills, fatigue, stiff neck, arm soreness
43 2021-01-12 lymph node swelling Muscles pains, with spasms; Muscles pains, with spasms; Nausea; Lymphadenopathy on the left side of ... Read more
Muscles pains, with spasms; Muscles pains, with spasms; Nausea; Lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit.; Lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit.; Too weak to perform normal activities/slept for 2 days straight; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: El1284 and Expiration Date unknown) via intramuscular route of administration on 05Jan2021 11:00 AM (Left arm) at single dose on arm for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: Eh9894) via intramuscular route of administration on 17Dec2020 05:00 PM (Left arm) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included known allergy and None other medical history. The concomitant drug was reported as Birth control medication. On 06Jan2021 1:30 am the patient woke up with severe all over muscles pains, with spasms that Tylenol 1000mg did not resolve. The patient had nausea, lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit. The patient slept for 2 days straight, too weak to perform normal activities. The patient continued to have some symptoms 3 days later. No treatment received for the adverse events of nausea, lymphadenopathy, pain in armpit, slept for 2 days straight, too weak to perform normal activities. No COVID prior vaccination and no COVID tested post vaccination. The outcome of event was recovering.
43 2021-01-13 lymph node swelling My lymph nodes were very swollen after receiving the vaccine. I also developed headaches and body ac... Read more
My lymph nodes were very swollen after receiving the vaccine. I also developed headaches and body aches, and fatigue. The result of my mammogram and ultrasound confirm the swollen lymph nodes. If they are still the same in 3 months we will schedule a biopsy.
43 2021-01-13 lymph node swelling Swollen lymph nodes
43 2021-01-13 peripheral swelling, swelling My armpit is swollen; Swelling in the arm; Fever; Ache; Headache; Flu like symptoms; This is a spont... Read more
My armpit is swollen; Swelling in the arm; Fever; Ache; Headache; Flu like symptoms; This is a spontaneous report from a contactable Physician (patient). A 43-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EL1284), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), birth control. Concomitant medication included omeprazole for GERD, estradiol pills for birth control. The patient got the second dose of the Pfizer vaccine and she had some pretty severe flu like symptoms afterwards in Jan2021. But she noticed something odd and that was her armpit was swollen. She thought that is listed as one of the side effects but she wanted to know more about it. She had a pneumococcal vaccine (Unspecified vaccine) reaction and she wanted to make sure that there was nothing that would cross reactivity associated with this vaccine (Covid19 Vaccine). The weight is like 160. About 10 hours, she got 2 or 3 symptoms. Fever, aches, headache, bad headache. That lasted about overnight on the 05Jan2021. Swelling in the arm only started on 06Jan2021. That was when the armpit got swollen. The outcome of the events were unknown.
43 2021-01-13 swelling arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightne... Read more
arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy. The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL). The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant. On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly. On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened. The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown. The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-01-14 anaphylactic reaction Immediate itching and hives. Progressed quickly into anaphylaxis - stridor, difficulty breathing. Ta... Read more
Immediate itching and hives. Progressed quickly into anaphylaxis - stridor, difficulty breathing. Taken immedietly to ER, O2 sats observed of 84%. Given IM Epi in ER triage area. Brought back to room, racemic epi started and given additional IM dose. Please refer to ED for further treatment.
43 2021-01-14 anaphylactic reaction 5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of ... Read more
5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of breath tachycardia, nausea. Taken to ER and given IM Epi, IV Benadryl, Solumedrol, Pepsi?s, albuterol and racemic epi breathing treatments and put on Epinephrine IV drip to treat anaphylactic reaction
43 2021-01-14 lymph node pain approx 27 hours after dose #2 developed fever which reached 102 F, chills, body aches, lymph node te... Read more
approx 27 hours after dose #2 developed fever which reached 102 F, chills, body aches, lymph node tenderness. At present, large reddened area at and below injection site and lymph tenderness
43 2021-01-14 lymph node swelling tiredness; headache; Injection site pain; injection site swelling; swollen lymph nodes under arm; mu... Read more
tiredness; headache; Injection site pain; injection site swelling; swollen lymph nodes under arm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot/batch number not reported, via an unspecified route of administration from 07Jan2021 12:45 to 07Jan2021 12:45 as SINGLE DOSE for COVID-19 immunisation. Medical history Known allergies: penicillin, almonds, raw carrots. Other medical history: Thyroid cancer, seasonal allergies, asthma. The patient previously tested positive for COVID-19 prior vaccination. The patient is not pregnant. The patient's concomitant medications were not reported. On 07Jan2021 18:00, the patient experienced injection site pain, tiredness, headache, muscle pain, injection site swelling, swollen lymph nodes under arm. The outcome of the events was not recovered. Information about lot/batch number has been requested.
43 2021-01-14 lymph node swelling On 1/9/21, patient reported to urgent care for lower back pain. Patient also reported chills, adenop... Read more
On 1/9/21, patient reported to urgent care for lower back pain. Patient also reported chills, adenopathy, headache, and hypertension. Patient was given prescription of diclofenac and cyclobenzaprine. No further escalation of care.
43 2021-01-14 peripheral swelling Hospital Course:   Patient is a 43 y.o. female patient who originally presented to the hospital on... Read more
Hospital Course:   Patient is a 43 y.o. female patient who originally presented to the hospital on 1/3/2021 due to Left lower extremity pain and swelling. Patient found to have extensive DVT of left lower extremity and started on heparin drip. Vascular was consulted and recommended thrombolysis. Patient was also seen by IR who took patient for thrombectomy and left iliac stent placement on 01/05/2021. Patient tolerated procedure well. Patient was transitioned from heparin drip to Eliquis upon discharge. Patient given vascular follow-up as well as Hematology follow-up.
43 2021-01-15 lymph node pain 1/15/21 awoke with under right arm very tender (no redness)
43 2021-01-15 lymph node swelling Rash, swollen lymph node, fever
43 2021-01-17 oral herpes COld sores on bridge of nose near right eye
43 2021-01-17 swelling face Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred per... Read more
Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred peripheral vision in left eye only. Dizziness, wooziness. All resolved with 35 minutes of injection, initially. Within 4 hours of shot-Exponential increase in pain from waist down, including lower back pain. Took Motrin 600 mgs which resolved pain within 1 hour of taking it. Felt off/not myself-Felt foggy-headed-pressure in head and ears was not normal. 2100-0000 (Evening of shot)-Moderate sporadic dizziness that became moderate constant dizziness-Took 1 25 mg chewable Meclizine with 1 cup of water. Pain increased and Motrin wore off. Fatigue grew worse. 1/13/21-1/14/21-SEVERE back pain. Intense pain in legs and hips. Upper respiratory symptoms-Nasal congestion, ear pressure, sinus pain/pressure, chest and upper back discomfort, chest congestion, irritation, and aching. Cheeks and nose looked puffy/swollen. Eye pain, headache on and off. Fatigue, dragging. Felt feverish but no actual fever. Body aches-sides, legs-front, back, and sides, lower back, and glutes. Felt like arthritis from waist down, including lower back. Took nighttime cold syrup, etc. to be able to sleep and/or at least dull the pain. Also used heating massage pad to assist with pain relief. 1/15/21-1/16/21-Pain lessened in terms of intensity. Had longer spells of less intense pain. Also less pain with movement after resting/lying down. However, pain still intense at this point. Meds more helpful with the pain at this point as well. On Sat, felt dizzy and unwell all day, including extra tired. Hot, sweaty on Sat. Racing heart, chest tightness. Used inhaler and Metoprolol. 1/17/21-Felt unwell-intense pain still, dizziness, fatigue. Took Meclizine 25 mg that morning. Also took another 25 mg Meclizine later that afternoon. Nausea, dry heaving to the point I almost vomited 2x. After napping, nausea returned slightly but immediately went away. Felt very tired remainder of the evening. 1/18/21-Went to MD to get clearance to return to work. Dizziness prior to visit and took 1/2 25 mg Meclizine. Felt better until I got to doctor's office. While waiting to be called back, dizziness started up again and got severe. While waiting on MD to come in and talk to me, I got nauseated and felt like I might dry heave/vomit. I took another 1/2 Meclizine 25 mg and sucked on a mentholated cough drop to help with nausea, which did subside. Dizziness continued to be severe. MD took blood pressure, pulse ox, checked my ears, checked my pupils, listened to me breathe, asked me about my symptoms, return to work, and advised on safety of taking 2nd COVID injection when it is time but leaving it up to me in terms of if I feel benefits outweigh possible side effects of 2nd injection. He prescribed anti-nausea meds, pain meds, and stated he wants to see me for a follow-up visit in 1 week. He also prescribed steroid and pain med injections to be administered in office immediately, steroid injection sometimes contains Benadryl and based on how I felt after the shot, there may have been Benadryl in this one. He also requested I message him later in the day to let him know how I was feeling. Injections did GREATLY assist with pain and dizziness/foggy-headed feeling, once they kicked in. I did message him letting him know how I was feeling after napping. 1/18/21 evening-I am still feeling weak and tired and having stinging like pain in both legs along with minor lower back pain. Some chest and throat irritation as well as stomach discomfort. Going to take a gentle laxative as well as some of the nighttime cold medicine I purchased. Still also having dizziness on and off. I plan to return to work tentatively, on 1/19/21, per my return to work note from MD. I will keep my MD notified of how I feel between now and next Monday's follow-up.
43 2021-01-17 white blood cell count increased Received vaccine on 1/4 in the morning and it was fine until the evening, then got the sore site and... Read more
Received vaccine on 1/4 in the morning and it was fine until the evening, then got the sore site and mild malaise, wen to be early and slept all night. Next several days feeling extra tired especially in the evenings. On 1/12 I got up at 05:30 feeling fatigued and super tired, i call out work. I slept for most of the day and called occupational health (OH) and they scheduled a PCR Covid test for the next day 1/13, which came back negative. (1/14) still feeling fatigued, having palpitations and noticed my heart rate increasing significantly with mild exertion such as walking and eating, so I reached out to my PCP, who ordered labs and a second PCR Covid test for 1/15. Labs returned the next day 1/15 with elevated WBC and second Covid test came back negative on 1/16. Felt a bit better on Sunday 1/17, but today 1/18, I am still very tired and my heart continues to increase when I get out of bed, eat, shower or do any simple thing, my heart rate jumps from 64-68 to 115-120s, called my PCP back and he is seeing me tomorrow morning for an EKG and other tests, and I have been out of work for a week. I take no prescriptions drugs and have no health problems.
43 2021-01-18 lymph node swelling intermittent fevers, extreme muscle ache, Left axillary lymphadenopathy for over 24 hours. Took ibup... Read more
intermittent fevers, extreme muscle ache, Left axillary lymphadenopathy for over 24 hours. Took ibuprofen and tylenol which exacerbated stomach ache. Then took sucralfate and esomeprazole and tylenol supp.
43 2021-01-18 lymph node swelling Swollen Lymph node in left collar bone area about 1 inch around
43 2021-01-18 lymph node swelling received injection before noon, by 1800 reported mild chills. After midnight, chills became worse, ... Read more
received injection before noon, by 1800 reported mild chills. After midnight, chills became worse, temp=101.6. Severe chills 0400, diaphoresis. 0900 body aches, especially back and legs. swollen axillary lymph node on arm of injection. Began vomiting intermittently until 1630. two days post injection awoke fully recovered with exception of tender, swollen axillary lymph node on arm of injection.
43 2021-01-18 swelling face Bilateral facial/eye swelling; hives from scalp to tip of toes, hives on Fupa & lips, hives/welts wo... Read more
Bilateral facial/eye swelling; hives from scalp to tip of toes, hives on Fupa & lips, hives/welts worse on chest, bilateral arms, neck & back, left sided headache from behind eye to base of neck
43 2021-01-19 anaphylactic reaction, swelling face Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an ... Read more
Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.
43 2021-01-19 lymph node swelling Body and muscle pain, joint pain, fatigue, site pain-started within 24 hrs of injection lymphadenopa... Read more
Body and muscle pain, joint pain, fatigue, site pain-started within 24 hrs of injection lymphadenopathy and nausea- started 48 hrs after injection
43 2021-01-19 lymph node swelling near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observat... Read more
near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observation increased heart rate, light headed, orthostatic after vaccine continued w/ rapid heart rate, light headed and orthostatic for 3 days day 2 severe body aches, chills, fatigue and headache,, arm pain only at injection site, swollen lymph nodes- Tylenol taken but barely touched pain day 3 still joint aches and headache, fatigue and chills, slight arm pain only at injection site, swollen lymph nodes- Tylenol and rest day 4 felt better, rash began on torso and spread to arms, groin , neck, swollen lymph nodes day 4 rash which began to itch lasting day 4,5,6,7,8- took Benadryl so I could sleep, swollen lymph nodes Continue w/ intermittent chills, body aches, headache and light headed for day s 4,5,6,7,8 Continue w/ swollen lymph nodes under left and right arm and today is day 14
43 2021-01-19 swelling face My right arm at injection site is swollen and hurts and my left side of my face is swollen.
43 2021-01-19 swelling Swelling at left side of the neck. Hard area at injection site. Prescribed diphenhydramine and pred... Read more
Swelling at left side of the neck. Hard area at injection site. Prescribed diphenhydramine and prednisone
43 2021-01-20 lymph node pain, lymph node swelling Red, swelling and itching at injection site. Started 15 hours after injection and still present 57 h... Read more
Red, swelling and itching at injection site. Started 15 hours after injection and still present 57 hours after injection. Swelling of lymph nodes and pain in lymph node region in the same arm. Unable to turn a steering wheel due to pain or pick up objects with right hand. Reaction has followed the same time line as the arm. Pain is so severe that it prevents sleep.
43 2021-01-20 lymph node swelling, lymph node pain swollen lymph nodes in right armpit that were tender; swollen lymph nodes in right armpit that were ... Read more
swollen lymph nodes in right armpit that were tender; swollen lymph nodes in right armpit that were tender; Body ache; Had low grade temp fever 99-99.5; Terrible headache; Fatigue/ tiredness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the right arm on 29Dec2020 12:15 at single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medication included levothyroxine sodium (SYNTHROID). On 30Dec2020, approximately 12 hour started with body ache; from 18 hours to 30 hours, patient had low grade temp fever 99-99.5 (I usually run 97.50), body ache, terrible headache, fatigue, tiredness- slept all but 3 hours throughout day, sore arm at injection site with warmth, swelling and redness. On day 3-4, the patient had swollen lymph nodes in right armpit that were tender. By day 5, the patient felt back to baseline. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.
43 2021-01-20 lymph node swelling, swollen extremities Swollen and pain lymph nodes in left armpit still 1/22, injection site pain still 1/22, joint pain s... Read more
Swollen and pain lymph nodes in left armpit still 1/22, injection site pain still 1/22, joint pain still 1/22, low grade fever ranging from 99.2-101 until only day after, headache still 1/22
43 2021-01-20 swelling SWOLLEN UNDERARM, TENDER TO TOUCH ON THE SAME ARM AS THE INJECTION.
43 2021-01-21 lymph node swelling I started with under arm- armpit pain last night and this morning noticed that my glands and or lymp... Read more
I started with under arm- armpit pain last night and this morning noticed that my glands and or lymph nodes under the left arm are very swollen- knots. It alarmed me. I have also had diarrhea since the day of vaccine and just feel over all flushed and very sleepy/tired.
43 2021-01-21 lymph node swelling swelling in her lymph nodes on the right side/ neck; soreness on the side of my face; Discomfort; Th... Read more
swelling in her lymph nodes on the right side/ neck; soreness on the side of my face; Discomfort; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received one dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via unspecified route single dose for protection from COVID-19 2 o' clock or 3 yesterday (09Jan2020), at 43-year-old. Medical history included: multiple sclerosis. Concomitant medication included: sertraline 50 mg once daily at night; antidepressant (unspecified). The patient previously took glatiramer acetate (COPAXONE) once for multiple sclerosis and amantadine, was allergic to both. The patient didn't notice soreness on the side of her face, was probably from the vaccine started yesterday (09Jan2020). The patient was doing fine but then noticing was getting swelling in her lymph nodes on the right side. The patient did not notice the swelling, but she noticed the discomfort first last night (09Jan2020), '9th, 10 pm' (not clarified further). The patient thought that it was a 'pimple' (not further clarified) there. And then later today (10Jan2020), or just maybe an hour ago, when she felt that on her neck, she found lymph nodes swollen. So far, no treatment was taken. No lab work done. Action taken for BNT162B2 was not applicable. Outcome of the events was resolved.
43 2021-01-21 lymph node swelling A mammogram is performed and the results showed left axillary lymph nodes with mild cortical thicken... Read more
A mammogram is performed and the results showed left axillary lymph nodes with mild cortical thickening
43 2021-01-22 lymph node inflammation, lymph node pain Axillary Lymphadenitis. Lymph node is hard and painful. Large amount of fluid swelling protruding ou... Read more
Axillary Lymphadenitis. Lymph node is hard and painful. Large amount of fluid swelling protruding outwards from armpit. Larger than a golf ball but smaller than a baseball. Aching sensation.
43 2021-01-22 peripheral swelling Started with mild headache 1/7 night. Near 5am 1/8 had severe rib pain on right, 7am loose stools, m... Read more
Started with mild headache 1/7 night. Near 5am 1/8 had severe rib pain on right, 7am loose stools, midday body aches, chills, finger swelling and joint swelling ha, fvr low grade. I took ibuprophen. By evening add nausea, vomitting, near syncopal event (had to sit quickly b4 passing out), heart palpitations, light headed, chest pressure and just off feeling, fatigue. By 1/9 all same symptoms, 2 more near -syncopal events, rt knee pain, and asthma (I used inhaler x 3 times). Then 1/10 upon waking, I felt amazing and 100% better. During first 3days of symptoms, I slept alot.
43 2021-01-23 lymph node pain, lymph node swelling Swollen/painful lymph node for 5 days
43 2021-01-24 lymph node pain, lymph node swelling Mild chills, fever and body aches for 24 hours - treated with ibuprofen Severe lymphadenopathy of le... Read more
Mild chills, fever and body aches for 24 hours - treated with ibuprofen Severe lymphadenopathy of left axillary region and upper left chest wall below collar bone - accompanied by pain and discomfort Pain lasted ~4-5 days. Swelling fully resolved on Day #8 after injection. Treated with ibuprofen and pillow under arm. 1 missed day of work
43 2021-01-24 peripheral swelling arm was inflamed, and so swollen; arm was inflamed, and so swollen; This is a spontaneous report fro... Read more
arm was inflamed, and so swollen; arm was inflamed, and so swollen; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had a reaction after the vaccine. The first vaccine her arm was inflamed, and so swollen, she couldn't move it. Outcome of the events was unknown. Information on the lot/batch number has been requested.
43 2021-01-24 peripheral swelling I received an instant headache, my left arm swelled and was painful from my shoulder down to my hand... Read more
I received an instant headache, my left arm swelled and was painful from my shoulder down to my hand. Later in the day i became extremely tired, had pain in my neck. The next day i was still very tired, arm pain, headache, body aches, vomiting. Day 4 i am still very tired with body aches.
43 2021-01-25 lymph node swelling Forgetfulness; brain was foggy; She was very tired; couldn't move her arm; Headache/If she didn't ta... Read more
Forgetfulness; brain was foggy; She was very tired; couldn't move her arm; Headache/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; generalized body pain/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; swollen lymph nodes in her left arm pit/couldn't move her arm; This is a spontaneous report from a contactable nurse reporting for herself. A 43-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical Vaccine included received first dose of BNT162B2 on unspecified date for COVID-19 immunization and her arm was inflamed, and so swollen, she couldn't move it. Caller was instructed to call after getting the COVID vaccine. She had a reaction after the vaccine. Her doctor said to call Pfizer. It was after she received the 2nd dose of the vaccine, Saturday (09Jan2021). She had a reaction. She developed a headache and fatigue. She had had these side effects since Saturday. They have lasted Sunday, Monday, and today/Tuesday. She was very tired, and she has generalized body pain. The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back. Literally, her whole body was so painful. She had been taken Ibuprofen 800mg and Tylenol 1g. She had been taking those every 8 hours. She took them together. When she took them, her headache and body pain was maybe a 5-6/10. If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain. She also had swollen lymph nodes in her left arm pit. Which is the arm they injected the vaccine into. She just noticed it Saturday night. She couldn't move her arm. Now, after the second, she had a swollen lymph node the size of a quarter. It had been the same size since Saturday. She was wondering if it would go away? She was also becoming forgetful. Her brain was foggy-ongoing. Like she forgot her doctors appointment today. The outcome of event "brain was foggy" was not resolved while outcome of other events were unknown. Information on the lot/batch number has been requested.
43 2021-01-25 lymph node swelling SIGNIFIGANT SWELLING AT VACCINE SITE, SWOLLEN LYMPH NODES UNDERARM AND UP NECK ON RIGHT SIDE, FATIGU... Read more
SIGNIFIGANT SWELLING AT VACCINE SITE, SWOLLEN LYMPH NODES UNDERARM AND UP NECK ON RIGHT SIDE, FATIGUE, LOW FEVER, ACHES & CHILLS, HEADACHE
43 2021-01-25 swollen extremities chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetir... Read more
chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetirizine x 1 po vital signs stable
43 2021-01-25 peripheral swelling Joint pain; Arm swelled up from the shoulder to the elbow and around to the inner arm; It is hot, ha... Read more
Joint pain; Arm swelled up from the shoulder to the elbow and around to the inner arm; It is hot, hard, swollen, and extremely painful; from the shoulder to the elbow and around to the inner arm. It was hot, hard, swollen, and extremely painful.; Arm swelled up from the shoulder to the elbow and around to the inner arm; Headache; Low grade fever of 100.2F; This is a spontaneous report from a contactable other healthcare professional. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176; expiry date: unknown) via an unspecified route of administration in the left arm on 08Jan2021 on 15:00, at a single dose, for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), bariatric surgery, seasonal allergies, and known allergies to bee stings, flu vaccine, and monosodium glutamate (MSG). Concomitant medications included famotidine (PEPCID) and cetirizine hydrochloride (ZYRTEC), and multivitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) on 17Dec2020, at 01:00 PM, in the left arm, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 09Jan2021, at 14: 30, the patient's arm swelled up from the shoulder to the elbow and around to the inner arm. It was hot, hard, swollen, and extremely painful. She also had joint pain, headache, and low-grade fever of 100.2 Fahrenheit (F). The patient did not received therapy for the events. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
43 2021-01-26 swelling, swelling face 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, j... Read more
1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; eye lower lid internal tenderness; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Dizziness; sleepiness; increased blood pressure and pulse; increased blood pressure and pulse; Then sleeplessness till 4am next day; This is a spontaneous report from a contactable Nurse A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 15Jan2021 14:45 at single dose for covid-19 immunisation. Vaccine location was right arm. Medical history included attention deficit hyperactivity disorder from an unknown date, hypothyroidism from an unknown date. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient experienced 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch on 15Jan2021 15:15 with outcome of not recovered, behind lower rt (right) ear pain, rt (right) sided neck pain, rt (right) side buttocks pain, rt (right) side thigh pain, swelling, rt (right) knee pain, and swelling on 15Jan2021 15:15 with outcome of not recovered, dizziness on 15Jan2021 15:15 with outcome of not recovered, sleepiness on 15Jan2021 15:15 with outcome of not recovered, increased blood pressure and pulse on 15Jan2021 15:15 with outcome of not recovered, then sleeplessness till 4am next day (as reported) on 15Jan2021 15:15 with outcome of not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-01-27 anaphylactic reaction dyspnea, anaphalaxis
43 2021-01-27 lymph node swelling, lymph node pain Per patient: patient developed sore/swollen glands on neck on 1/23/2021 (morning after receiving vac... Read more
Per patient: patient developed sore/swollen glands on neck on 1/23/2021 (morning after receiving vaccine). Lymph nodes along clavicle on right side are swollen/sore as well. Patient went to provider's office on Monday (1/25/2021) for symptoms. Patient states that lymph nodes on neck are better today, but lymph nodes along clavicle on right side continue to worsen. Patient is in contact with her provider.
43 2021-01-27 swollen extremities Significant swelling in armpit region of injection arm (- Approximately size of golf ball). Began u... Read more
Significant swelling in armpit region of injection arm (- Approximately size of golf ball). Began upon waking morning after injection, and still present at this time (72 hours later). Area is tender to touch.
43 2021-01-28 swollen extremities chills, body aches, nausea, swelling under left arm pit Had to take off work 01/28/21 no doctor
43 2021-01-29 peripheral swelling, lymph node swelling cellulitis in arm given an antibiotic and a steroid right arm is swollen red and hot cause pain to ... Read more
cellulitis in arm given an antibiotic and a steroid right arm is swollen red and hot cause pain to chest back and i developed a lump in a armpit
43 2021-01-31 axillary mass have a knot in the injection site and it has redness in that area. Also have a knot in the arm pit ... Read more
have a knot in the injection site and it has redness in that area. Also have a knot in the arm pit that is as big as fist. no redness to it.
43 2021-02-01 lymph node swelling Post vaccine-developed swollen lymph node under Left arm, headache, nausea, lethargy. This resolved ... Read more
Post vaccine-developed swollen lymph node under Left arm, headache, nausea, lethargy. This resolved by day three. Day 4 started having periods of extreme vertigo, this is happening more frequently and with more severity up to today 2/2/2021 woke with severe dizziness and nausea, fell over when rising from bed. continue to be very dizzy and nauseated
43 2021-02-01 lymph node swelling swollen lymph node in the left arm pit; This is a spontaneous report from a contactable consumer. A ... Read more
swollen lymph node in the left arm pit; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiry date: unknown), via an unspecified route of administration in the left arm, on 15Jan2021 at a single dose for covid-19 immunisation. Medical history was reported as none. Concomitant medication included desogestrel, ethinylestradiol (KARIVA) in Sep2020 for birth control. There was no history of all previous immunization with the Pfizer vaccine. The patient had no prior vaccination within four weeks. On 17Jan2021, the patient experienced swollen lymph node in the left arm pit which became really noticeable. She reported she feels like she looks deformed due to the swollen lymph node. She had bloodwork drawn about 1.5 weeks ago (Jan2021) but has not received the results from that yet. The event did not require emergency room or physician office visit. The patient was not hospitalized. Outcome of the event was not recovered.
43 2021-02-01 oral herpes Cold sore (herpes labialis); This is a spontaneous report from a non-contactable physician (Patient)... Read more
Cold sore (herpes labialis); This is a spontaneous report from a non-contactable physician (Patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration on 08Jan2021 20:30 (08:30 PM) at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. Medical history included allergies with mango. No other medical history. There were no concomitant medications (reported as "Other medications in two weeks: No"). No other vaccines in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient received the first dose on 17Dec2020 03:00 PM (lot number: EH9899) on the right arm. The patient experienced cold sore (herpes labialis) on 11Jan2021 20:00 (reported as "08:00 PM"). No treatment was received for the event. Outcome of the event was recovered in Jan2021. Patient was not tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.
43 2021-02-02 anaphylactic reaction Anaphylaxis refractory to IM episode x3, steroids, H1 blocker requiring incubation. Specifically res... Read more
Anaphylaxis refractory to IM episode x3, steroids, H1 blocker requiring incubation. Specifically respiratory distress with stridor, nausea, and generalized abdominal pain.
43 2021-02-02 lymph node pain I have pain in my right axillary area, or lymph nodes.
43 2021-02-02 lymph node swelling Patient developed tachycardia at 0600 on 2/2/21 and reported to the ED with heart rate in the 190's.... Read more
Patient developed tachycardia at 0600 on 2/2/21 and reported to the ED with heart rate in the 190's. ED notes as follows. Discharged in stable condition with a Holter monitor. Initial Vital Signs [02/02/21 0713] Blood Pressure 139/93 Heart Rate 126 Respiratory Rate 18 Temp 37.2 °C (98.9 °F) Temp src Oral SpO2 99 % 43 y.o. female who arrived to the emergency department for Palpitations and tachycardia. Patient states that the symptoms started approximately 545 this morning while getting ready for work. She states that palpitations started spontaneously with no inciting event. She denies chest pain or shortness of breath. She states that she felt the palpitations and looked down to her watch and showed a heart rate into the 190s to 220s. Upon arrival to the emergency department her heart rate is in the 190s. When she was brought back to the room, her heart rate was around 120-130. Still denying any chest pain or shortness of breath. She did receive her second for Covid vaccine yesterday. No reaction with the first vaccine. No changes in medication, caffeine intake. Denies smoking, drinking, drug use. No history of similar events. Father has a history of a heart block requiring pacemaker. Medical history of melanoma varicose veins but no cardiac or pulmonary history including pulmonary embolism.Patient is a nurse in the neurosurgical unit as one of the case managers During initial evaluation, patient was sitting in bed in no acute distress. Vitals signs stable tachycardia although better than initially arriving. Physical exam unremarkable. Labs indicate elevated D-dimer. We will proceed with CT PE. CT scan of scan shows no signs of PE there is evidence of left axillary adenopathy which is consistent with her vaccination yesterday. Upon repeat evaluation, patient was updated regarding lab and imaging results. Heart rate had improved greatly down to the 90s to low 100s. She was able to ambulate around without becoming grossly tachycardic, dizzy, lightheaded or shortness of breath. Unsure of exact cause of palpitations and tachycardia. Recommend outpatient monitoring with Holter monitor. Follow-up with primary care provider or cardiologist. Return to emergency department if symptoms return or new concerning symptoms occur. Treatment plan was discussed with the patient who was agreeable and exhibited understanding. Questions were answered to patient's satisfaction. Through shared decision making with the patient and the emergency medicine care team, we discussed and decided the patient is stable and ready for discharge. Patient remained hemodynamically stable in the emergency department. Patient was provided with verbal and written follow-up/discharge instructions and return precautions. Recommend follow up with PCP in 2-3 days for symptom re-evaluation and further management. Patient should return to emergency department if symptoms worsen or new concerning symptoms develop.
43 2021-02-02 peripheral swelling I?m still not sure what to make of my reaction. Started to feel ?out of body?, slow and had left-sid... Read more
I?m still not sure what to make of my reaction. Started to feel ?out of body?, slow and had left-sided chest pain at around 8 minutes after administration. Then flagged down a nurse. They checked my blood pressure at 196/110 (first one may have been 210/110)- I was sort of disoriented. Sat there for about an hour with repeated blood pressure checks, until my pulse went from 118 down to 90. They let me go home at 170/100. I do t have hypertension. Then went and laid down in my office nearby and my left upper arm turned bright red and became painful and slightly swollen. Took five hours for my blood pressure to drop to 118/80- my normal is 114/78. Still have weird chest pain and some SOB with exertion (not normal for me).
43 2021-02-03 lymph node swelling, swelling Swelling of lymph node in right armpit originally. Swelling and fluid spread - filling right side of... Read more
Swelling of lymph node in right armpit originally. Swelling and fluid spread - filling right side of body, across right collar bone, halfway down torso and slightly around the back. It also spread down the right arm halfway to elbow. The on-call nurse originally thought it could be cellulitis but after being told there was no redness or itchiness, she was unsure of the diagnosis and suggested to talk with the on-call doctor or go to the ER. The on-call doctor really had no idea as to what was going on. Once at the ER, the doctor checked with other doctors and read as much as he could about this type of reaction. Nothing he read matched up exactly with what was going on. He did note some swelling of lymph nodes had been reported but not to this extent. With all this being new, he suggested to go home and watch the swelling and come back if things got worse. For several days, there continued to be no redness or itchiness. The discomfort was only in the lymph node in the right armpit, with some slight pressure from the skin tightening around the fluid on the arm. Within a week, the welling was completely gone and the lymph node discomfort lasted a couple days more. I feel it necessary to note that I don't believe the shot was given in the correct location. As soon as the needle entered the skin, my thought was 'that is too high' and there was a pain like I have never felt with a vaccine before. That pain subsided shortly after the injection but it was several days before the injection site felt better. Now, two weeks later, I have a constant pain in my shoulder, slightly down my arm and into my collar bone area. There are also times when the pain throbs or shoots through as well. I believe this pain may be due to the placement of the shot, and not necessarily from the vaccine itself.
43 2021-02-03 swelling face Within 2 mins of shot: Tachycardia, dizziness, some mild shortness of breath/chest tightening, redd... Read more
Within 2 mins of shot: Tachycardia, dizziness, some mild shortness of breath/chest tightening, reddening of face/chest (and strange almost metallic taste in mouth). The metallic taste subsided quickly (within 2 mins) tachycardia subsided quickly (within 5-10min), and I felt dizzy for approx 30mins (the skin on my chest still looks slightly red approx 2 hours later). The next day/morning I awoke with slightly puffy/swollen face and upper lip lightly swollen/tingly
43 2021-02-03 swelling, lymph node swelling woke with myalgias (left-sided) and significant pain left axilla.; woke with myalgias (left-sided) a... Read more
woke with myalgias (left-sided) and significant pain left axilla.; woke with myalgias (left-sided) and significant pain left axilla.; swollen axilla and golf-ball sized lymphadenopathy; swollen axilla and golf-ball sized lymphadenopathy; mild fever (100.4) in AM; This is a spontaneous report from a contactable physician who reported for herself. A 43-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL1283) Intramuscularly at left arm 15:15 on 17Jan2021 for Covid-19 immunization. Patient received her fist shot (Lot number EI0142) intramuscularly at left arm 06:45 PM on 27Dec2020. The patient had a medical history included factor V leiden, and Hashimotos thyroiditis. Patient had no known allergies. Concomitant medications included rivaroxaban (XARELTO), levothyroxine, rizatriptan benzoate (MAXALT). No other vaccines were taken within four weeks. 12 hours post vaccine (around 04:00 AM on 18Jan2021), patient woke with myalgias (left-sided) and significant pain left axilla. It was noted swollen axilla and golf-ball sized lymphadenopathy. Also, she had mild fever (100.4) in AM. The patient had no COVID prior vaccination and had no COVID tested post vaccination. The outcome of the events was unknown. Amendment: This follow-up report is being submitted to amend previously reported information: Laboratory test "mild fever (100.4)" as "Body Temperature" updated in lab data section in Patient tab.
43 2021-02-04 anaphylactic reaction 15 minutes after first Pfizer Covid injection, pt developed itchy throat, given benadryl 50 po and m... Read more
15 minutes after first Pfizer Covid injection, pt developed itchy throat, given benadryl 50 po and monitored. Continued to have itchy throat and some rash, felt like prior episodes of anaphylaxis, reported some sob though stable vital signs, sent to ED
43 2021-02-04 lymph node swelling, lymph node pain Severe pain in injection arm run from shoulder to fingers, eventually extended to chest wall on the ... Read more
Severe pain in injection arm run from shoulder to fingers, eventually extended to chest wall on the right side. Lymph node in right axilla sore, swollen and tender. Symptoms lasted 48 hours. Advil taken for symptoms.
43 2021-02-04 lymph node swelling Swollen lymph nodes; sensitive skin; body aches; muscle aches and pain; prolonged headache (excess o... Read more
Swollen lymph nodes; sensitive skin; body aches; muscle aches and pain; prolonged headache (excess of 7 days); This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142), via an unspecified route of administration in the left arm on 14Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient had no known allergies. Concomitant medication included levothyroxine sodium (LEVOXYL), liothyronine, and sertraline. Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE on 28Dec2020 (lot number: EJ1685) at 09:30 AM, in the left arm for COVID-19 immunization when the patient was 43-year-old. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior to vaccination nor was she tested since the vaccination. The patient experienced swollen lymph nodes, sensitive skin, body aches, muscle aches and pain, prolonged headache (excess of 7 days), all on 14Jan2021 at 03:00 PM with outcome of not recovered. There was no treatment received for the events. The events were reported as non-serious.
43 2021-02-04 lymph node swelling swelling of (most likely) lymph nodes in left armpit (same arm as vaccination); This is a spontaneou... Read more
swelling of (most likely) lymph nodes in left armpit (same arm as vaccination); This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 20Jan2021 14:15 at SINGLE DOSE at Left arm for covid-19 immunisation . Medical history included basal cell carcinoma. Concomitant medication included l-arginine [arginine]. The patient experienced swelling of (most likely) lymph nodes in left armpit (same arm as vaccination) on 21Jan2021 17:00. No treatment for the event. The outcome of event was not recovered. Information on the lot/batch number has been requested.
43 2021-02-05 lymph node swelling Lymph nodes swollen over neck and axil of the left side, pain and redness on the shot side .
43 2021-02-06 swelling Small redness around injection site then large red area 2-3 inches below injection site that is cont... Read more
Small redness around injection site then large red area 2-3 inches below injection site that is continuing to grow. Area is red warm and hard/swollen. Scratchy throat, rash on abdomen and back with no itch. Feel crappy.
43 2021-02-09 peripheral swelling Starting with itching on palms and then started to get worsen as days progressed. By Tuesday night t... Read more
Starting with itching on palms and then started to get worsen as days progressed. By Tuesday night the severity increased and started noticing red rashes. Went to ER Wed am and there were swelling noticed in palms and rashes through out the body.
43 2021-02-09 white blood cell count increased Patient got her 2nd covid shot on Thursday am. Felt fine Friday other then possibly a little achy an... Read more
Patient got her 2nd covid shot on Thursday am. Felt fine Friday other then possibly a little achy and totally fine Saturday. Felt somewhat fatigued Sunday afternoon. Woke early Monday am around 1am with sudden vomiting and diarrhea. Noted multiple loose stools and multiple episodes of vomiting and unable to tolerate eating or drinking. Also noted feeling cold. Noted feeling dizzy and lightheaded. Continues to feel achy. Came into Urgent care for fluids on Monday 2/8 and Tuesday 2/9.
43 2021-02-11 swelling face After the second dose I wasn?t feeling great, I slept an entire day and woke up Thursday feeling gre... Read more
After the second dose I wasn?t feeling great, I slept an entire day and woke up Thursday feeling great, Thursday evening I developed burning and itchy hives all over my neck chest and face, my face appeared swollen, I also had a smaller outbreak on my legs I took benedryl which seemed to calm the reaction some when I woke up the following morning, and another dose seemed to calm it some more
43 2021-02-12 lymph node swelling Left arm pit really sore- swollen lymph nodes
43 2021-02-14 lymph node swelling Fever, malaise - onset at 16h, relieved at 48h post-vaccine Left axillary lymph node swelling and di... Read more
Fever, malaise - onset at 16h, relieved at 48h post-vaccine Left axillary lymph node swelling and discomfort - onset at 24h post-vaccine, has not subsided
43 2021-02-14 lymph node swelling Body aches, mouth sores, swollen soar glands, difficulty swallowing
43 2021-02-14 swelling face Lips tingling; tongue felt full 4 mins after 1st injection; 24 hours later facial swelling and redne... Read more
Lips tingling; tongue felt full 4 mins after 1st injection; 24 hours later facial swelling and redness; 24 hours later facial swelling and redness; This is a spontaneous report from a contactable other health professional (HCP). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at 13:00 at a single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) and mild depression from an unknown date and unknown if ongoing. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), pantoprazole sodium sesquihydrate (PROTONIX) and levonorgestrel (MIRENA). The patient experienced lips tingling, tongue felt full 4 mins after 1st injection. Given IV steroids in ER. Twenty-four (24) hours later facial swelling and redness, more steroids given, symptoms resolved. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 26Dec2020 (covid test type post vaccination=Nasal Swab). Therapeutic measures were taken as a result of lips tingling, tongue felt full 4 mins after 1st injection, 24 hours later facial swelling and redness, 24 hours later facial swelling and redness. The outcome of the events was recovered on an unspecified date. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
43 2021-02-16 swelling face pt presented with erythema & swelling of face & periorbital regions C/O feeling fullness in tongu... Read more
pt presented with erythema & swelling of face & periorbital regions C/O feeling fullness in tongue & throat & some difficulty swallowing approx 30 - 45 min following vaccine Had also eaten a english muffin with plain cream cheese just prior to symptom onset She was noted to have mild swelling of her tongue & very sl lower lip She was administered 50 mg of diphenhydramine, 20 mg famotidine & 60 mg Prednisone & cold compress to face Was able to take all orally with water & had no difficulty -- after approx 30 minutes her s/s had much improved & her facial erythema & swelling had reduced no resp distress and O2 sat was 99%
43 2021-02-17 lymph node pain, lymph node swelling Pain and swelling in my lymph node in left armpit; Pain and swelling in my lymph node in left armpit... Read more
Pain and swelling in my lymph node in left armpit; Pain and swelling in my lymph node in left armpit; On 30Jan2021, the patient received the second dose BNT162B2 and first dose was received on 13Jan2021; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL8982), via an unspecified route of administration at the left arm on 30Jan2021 at a single dose for covid-19 immunization. The vaccine was administered in a hospital. The patient has no other medical history. There were no concomitant medications. The patient was not pregnant at the time of vaccination. Historical vaccine includes 1st dose of BNT162B2 for COVID-19 immunization, on 13Jan2021 12:00PM at the left arm, lot number: EL3246 at the age of 43 years. On 30Jan2021, the patient received the second dose BNT162B2 and first dose was received on 13Jan2021. On 01Feb2021 06:00 AM, the patient experienced pain and swelling in her lymph node in left armpit. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The events pain and swelling in my lymph node in left armpit recovered on Feb2021. No follow-up attempts are possible. No further information is expected.
43 2021-02-17 lymph node swelling Lump under collarbone
43 2021-02-17 swelling left armpit in arm tender swollen; left armpit in arm tender swollen; This is a spontaneous report f... Read more
left armpit in arm tender swollen; left armpit in arm tender swollen; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received her first doe of bnt162b2 (BNT162B2 reported as PFIZER -BIONTECH COVID-19 VACCINE; lot number: Em9810; expiration date: unknown), via an unspecified route of administration left arm on 02Feb2021 10:30 at a single dose for covid-19 immunization. The patient has no medical history and known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included clarithromycin (CLARITIN), zinc, ergocalciferol (VIT D) and vitamins nos (MULTIVITAMINS reported as mtv). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021 12:00 AM, the patient had left armpit in arm tender swollen. The events were non-serious, and no treatment was received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovering.
43 2021-02-17 swelling Vaccine at lunch time. Slight headache and tired within the hour. Awful rash started At commut... Read more
Vaccine at lunch time. Slight headache and tired within the hour. Awful rash started At commute Home. Welts. Hives swelling. For days.
43 2021-02-18 lymph node swelling Chills began at 10 pm. Fever at 101.5. Back and neck pain. Headache. Morning 2/17/21 could not get o... Read more
Chills began at 10 pm. Fever at 101.5. Back and neck pain. Headache. Morning 2/17/21 could not get out of bed. Extreme weakness, joint pain, back and neck pain, swollen gland under left armpit, pain, headache, fever up to 102.5. 2/18/21 low grade temp. 99.9. joint pain, headache. Used Tylenol, 2 pills every 4 to 6 hours.
43 2021-02-18 swelling, lymph node swelling I had Covid from March 14, 2020- April 1, 2020. I treated positive for antibodies in May 2020. I r... Read more
I had Covid from March 14, 2020- April 1, 2020. I treated positive for antibodies in May 2020. I received the first vaccine on 2/14/21 around 4:55 pm. 2/15-I awoke at 7am: sweating, headache, body aches/ pinging type sensation, fatigue, pain across my chest , no trouble breathing though. These are the same symptoms I had when I had Covid. 2/16 I was able to get out of bed, run errands, but still have headache, still feel achy, haven?t noticed a fever but I have had moments of sweating like one broke. Lymph nodes under my left arm are swollen and painful to touch. 2/17lymph nodes still very large and swollen, pings of 2/18: fatigue, weakness, 11pm- right arm became cold and numb like it was asleep, pinging muscle aches or more accurately pains where lymph nodes are located. Body seemed swollen overall too. 2/19: right arm and uncle still swollen and heavy Groin lymph area right side is painful today.
43 2021-02-18 swelling Within 5-10 minutes of injection initial sense of fullness in throat, throat clearing, mild difficul... Read more
Within 5-10 minutes of injection initial sense of fullness in throat, throat clearing, mild difficulty swallowing. No visible swelling. At 35 minutes after injection attempted to drink water, difficulty swallowing, coughing, no visible swelling. At 45-50 minutes post vaccine attempted to eat dinner (black beans and rice) difficulty swallowing, coughing. Again no visible swelling. Took Benadryl waited 15 minutes, able to eat dinner - resolved Other not resolved: Left arm pain referring up to neck and generalized swelling (loose shirt sleeve on Right is snug over left arm) , itchy ears
43 2021-02-20 lymph node pain, lymph node swelling 12 hours after injection: chills, fever started to elevate. 14-16 hours after =102° fever, fatigue... Read more
12 hours after injection: chills, fever started to elevate. 14-16 hours after =102° fever, fatigue, joint aches. Swollen lymph node in infected arm. Fever started to drop after 48 hours. Lymph node pain, joint pain, fatigue persists 3 days later.
43 2021-02-22 swelling Swelling of the lips- angioedema
43 2021-02-22 lymph node swelling Had 1st dose 12/18/20, had 2nd dose 1/8/21. On 1/15/21 noticed right cervical lymph node swollen >5c... Read more
Had 1st dose 12/18/20, had 2nd dose 1/8/21. On 1/15/21 noticed right cervical lymph node swollen >5cm. After 3 biopsies , diagnosed with non Hodgkin's lymphoma 2/11/21
43 2021-02-23 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe
43 2021-02-23 lymph node swelling Bone, joint, muscle aches. Headache. Weakness. 2/20/21 to 2/21/21 Swollen lymph nodes under arm and ... Read more
Bone, joint, muscle aches. Headache. Weakness. 2/20/21 to 2/21/21 Swollen lymph nodes under arm and into breast, bruising and tenderness. 2/20/21 to current Nausea and diarrhea 2/20/21 to current Exhaustion 2/20/21 to current
43 2021-02-23 swelling face Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM
43 2021-02-24 white blood cell count increased Pfizer COVID-19 Vaccine EUA Pt received 2nd dose of COVID vaccine 1/15/21. A few hours after receiv... Read more
Pfizer COVID-19 Vaccine EUA Pt received 2nd dose of COVID vaccine 1/15/21. A few hours after receiving vaccine, pt developed shoulder and neck pain. She felt feverish, chills that night but did not check temperature. Over next few days, she developed increasing generalized body aches, joint aches, headaches, weakness, fatigue. On 1/21/21 pt noted SOB and chest tightness, so she reported to ED. She checked her pulse ox and was 99%, was tachycardic to 140-150. She takes propranolol for essential tremor, so she took propranolol 40 mg PO x 1 and presented to ED on 1/21/21. In ED, pt was no longer tachycardic. Pt also states her concern for blood clot (mother had DVT in her 30s). She presented with moderate chest pain and tightness, as well as headache, weakness, SOB. Pt given APAP 1000 mg PO x 1, ibuprofen 800 mg PO x 1, orphenadrine 100 mg PO x 1. Nitroglycerin 0.4 mg SL x 1 ordered, but not given on MD's orders. Pt discharged home. 1/22/21: Pt f/u with hospital. DO says her elevated WBX and Cr were likely d/t vaccine and dehydration. DO offered to schedule f/u BMP and CBC on Monday 1/25. Pt also scheduled for outpt fluids at infusion center on Monday 1/25 in case BMP and CBC still indicate dehydration.
43 2021-02-25 lymph node swelling swollen lymph node the size of an egg under my left arm; temp of 100.8; chills; body aches; can't co... Read more
swollen lymph node the size of an egg under my left arm; temp of 100.8; chills; body aches; can't comprehend conversations (needing to ask the person talking to me to repeat 2 times); getting snappy almost because they repeated it; Felt a few times while standing/walking I could all the sudden fall asleep; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264, expiry date unknown), via an unspecified route of administration on the left arm, on 09Feb2021, at single dose, for COVID-19 immunisation, at a nursing home. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC), budesonide, formoterol fumarate (SYMBICORT), and ethinylestradiol, norethisterone (ALYACEN). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EV3247, expiry date: unknown) received at age 49 years, via an unspecified route of administration on the left arm, on 19Jan2021 10:30, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 11Feb2021 at 08:00, the patient experienced "swollen lymph node the size of an egg under my left arm, I had a temp of 100.8, chills and body aches. I have felt like I can't comprehend conversations (needing to ask the person talking to me to repeat 2 times, then getting snappy almost because they repeated it) and felt a few times while standing/walking I could all the sudden fall asleep but then few minutes later I feel normal and alert again." The patient had no headache or foggy head feelings. No treatment was given for the events. The outcome of somnolence was resolved, outcome for the rest events was not resolved. The reporter assessed the events as non-serious.
43 2021-02-25 swollen extremities Swelling and pain in right armpit started Thursday February 25 in the early afternoon. Causing pain... Read more
Swelling and pain in right armpit started Thursday February 25 in the early afternoon. Causing pain to radiate down arm. acetaminophen and cold packet to help with pain
43 2021-02-26 lymph node swelling Lymph nodes swollen on my left side where I received the shot
43 2021-02-27 lymph node swelling New and worsened reaction to food allergy/intolerance. After 20 years of small bites, I have built ... Read more
New and worsened reaction to food allergy/intolerance. After 20 years of small bites, I have built some immunity to certain foods. Since I received my vaccine I have had strong reactions to foods I usually tolerate with mild oral itching in very small portions. The first increased reaction was around 2 weeks after my first shot. About 2 hours after eating a very small portion of avocado, I woke up with a start with extreme tightness of my chest and gasping for air. I caught my breath after a few seconds then projectile vomited. Treated with 50mg Benadryl and returned to sleep after 45 minutes. I have never had any respiratory symptoms with a food allergy reactions. About 2 weeks after my second shot I accidentally ate a few bites of tomato which has not been a problem for over 10 years. After vomiting in my car and pulling off the road I saw my cervical lymph nodes were swollen to about 1.5 inches in diameter. I have never seen any thing like it. My airway was clear. I took 25mg of Benadryl, waited for 30 minutes, then drove home. I had a similar experience 3 weeks after my second shot with a fresh/homemade pickle that apparently was too raw. Vomiting with mildly swollen cervical lymph nodes treated with 25 mg Benadryl
43 2021-02-28 lymph node swelling Swollen lymph nodes in R armpit, generalized fatigue, 'fuzzy headedness'
43 2021-03-02 anaphylactic reaction Itching throat; cough; Taste and smell loss; Taste and smell loss; Taste and smell loss; mild anaphy... Read more
Itching throat; cough; Taste and smell loss; Taste and smell loss; Taste and smell loss; mild anaphylactic reaction; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 06:30 (at the age of 43-years-old) at a single dose for COVID-19 immunisation. Medical history included COVID-19 (with taste and smell loss). The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), hydroxyzine hydrochloride (MANUFACTURER UNKNOWN), and duloxetine (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 17Dec2020 at 14:00 in the left arm for COVID-19 immunization and experienced head to toe itching and progress with taste and smell disappeared/worse than COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild anaphylactic reaction on 16Jan2021 at 20:00 and itching throat, cough, and taste and smell loss on an unspecified date. The patient reported that all the progress she made with taste and smell, disappeared after the vaccine and was actually worse than when she got COVID-19. Therapeutic measures were taken as a result of mild anaphylactic reaction, which included diphenhydramine hydrochloride (BENADRYL). The clinical outcome of mild anaphylactic reaction was not recovered and of itching throat, cough, and taste and smell loss was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of event anaphylactic reaction cannot be excluded.
43 2021-03-02 swelling face Red flat itchy rash on torso, face, arms, legs; Red flat itchy rash on torso, face, arms, legs; faci... Read more
Red flat itchy rash on torso, face, arms, legs; Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth; Received first dose on 25Jan2021 and second dose on 11Feb2021; Received first dose on 25Jan2021 and second dose on 11Feb2021; This is a spontaneous report from a contactable Other Health Professional. A 43-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266), intramuscularly in Left arm on 11Feb2021 17:15 at single dose for covid-19 immunisation. Medical history included allergy to dairy products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) at the age of 43 years old and Intramuscularly in Left arm on 25Jan2021 17:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth on 12Feb2021 12:00. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has been tested for COVID-19 via Nasal Swab on 02Feb2021 with result Negative. Therapeutic measures (reported as 'IV Epinephrine, Solumedrol, 'Pepcid', 'Benadryl', prednisone) were taken as a result of red flat itchy rash on torso, face, arms, legs, facial swelling, eyes swollen, itchy throat, cotton mouth. The outcome of the events was not recovered. This case reported as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
43 2021-03-05 peripheral swelling Fever, Chills, muscle ache, joint pain, headache, fatigue, arm swollen
43 2021-03-07 lymph node swelling chills-started 4pm on 2/19 lasted until 10AM 2/20 muscle aches-started 12:00AM on 2/20 lasted until ... Read more
chills-started 4pm on 2/19 lasted until 10AM 2/20 muscle aches-started 12:00AM on 2/20 lasted until 10AM 2/21 Swollen lymph nodes-left armpit and behind head/neck area both sides started 2/20-lasted 3 days
43 2021-03-08 axillary mass felt a painful lump/mass under left arm (axillary) the day after receiving the vaccine 1/12/2021. I ... Read more
felt a painful lump/mass under left arm (axillary) the day after receiving the vaccine 1/12/2021. I had an office visit on 1/14*2021 because I continue to have arm pit swelling with tenderness. I was alternating between motrin or Tylenol around the clock for several days and pain was relieved with pain medication. Dr. provided breast examination and determined could be lymph node swelling caused by the vaccine and we should wait 1 more week for further eval. She said if swelling still there would order an ultrasound, luckily at day 5 sunday 1/17/2021 I finally felt no more swelling or pain. no further exams needed and a few weeks later heard on the news this situation was becoming more common with vaccine administration.
43 2021-03-08 swelling face Around ten minutes post injection PT experienced tingling throughout body, slight constriction in th... Read more
Around ten minutes post injection PT experienced tingling throughout body, slight constriction in throat, lungs clear throughout no wheezing, BP: 138/89, o2 saturation: 98%, HR: 89 PT then developed facial swelling , administered benedryl at 1815 PO, constriction continued as well as facial swelling post medication admin. PT declined Epi-Pen recommendation. At 1830 an addition PO administered, no change in PT condition. Decision to contact EMS at this point, Medic responded to the scene where patient was sent to hospital.
43 2021-03-09 anaphylactic reaction Anaphylactic reaction, splotchy skin
43 2021-03-09 swelling face Fatigue swelling of face Shortness of breath Cough Joint pain Headache Chest pain dizziness
43 2021-03-12 lymph node swelling, peripheral swelling left arm is swollen and painful then it started hurting in my armpit and my lymph node underneath m... Read more
left arm is swollen and painful then it started hurting in my armpit and my lymph node underneath my arm pit is swollen. Also had body aches and head ache through the night. That is better but the swollen arm and lymph node is not
43 2021-03-13 swelling face Swollen, itchy, hot rash starting below eyes and continuing to spread down face. Swollen throat with... Read more
Swollen, itchy, hot rash starting below eyes and continuing to spread down face. Swollen throat with mild discomfort.
43 2021-03-13 swelling face Face swelling (cheeks,, lips, eyes); Scratchy throat; Lips and face tingling; Heavy tongue.
43 2021-03-14 anaphylactic reaction Anaphylaxis: Closing throat, swollen mouth, sore throat, difficulty swallowing, difficulty breathing... Read more
Anaphylaxis: Closing throat, swollen mouth, sore throat, difficulty swallowing, difficulty breathing deeply, itchiness in mouth, blotching of skin
43 2021-03-15 lymph node swelling, lymph node pain fatigue 3 days, swollen painful lump lymph node under right arm 3 days, headache 1 day, painful at i... Read more
fatigue 3 days, swollen painful lump lymph node under right arm 3 days, headache 1 day, painful at injection site 4 days
43 2021-03-15 lymph node swelling, white blood cell count increased I exp swollen lymph nose on right clavicle. The swelling still there much smaller now
43 2021-03-15 lymph node swelling stuffy nose; body aches; sore throat; swollen glands in the throat; general not feeling well; This i... Read more
stuffy nose; body aches; sore throat; swollen glands in the throat; general not feeling well; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL-9265), intramuscular in left arm on 04Feb2021 at 04:30 PM at single dose for COVID-19 immunization in pharmacy or drug store. Medical history included penicillin allergy. Concomitant medications included bupropion, buspirone and several different vitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL-1283) in left arm on 14Jan2021 at the age of 42 years for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced stuffy nose, body aches, sore throat, swollen glands in the throat, general not feeling well on 05Feb2021 at 05:00 AM. No treatment was received for the adverse events. Patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
43 2021-03-16 lymph node pain, lymph node swelling Pain in left arm Swollen and painful lymph nodes in left armpit, radiating across back under shoulde... Read more
Pain in left arm Swollen and painful lymph nodes in left armpit, radiating across back under shoulder blades Nausea Fatigue All symptoms began roughly 12 hours after administration. Today is the fourth day, and symptoms are persisting.
43 2021-03-17 swelling Headache, Myalgia & Angioedema Narrative: Other Relevant History:
43 2021-03-17 lymph node swelling Dizziness, Headache, Myalgia, Arthralgia, Fever, FATIGUE, INJECTION SITE PAIN, SWOLLEN GLANDS Narrat... Read more
Dizziness, Headache, Myalgia, Arthralgia, Fever, FATIGUE, INJECTION SITE PAIN, SWOLLEN GLANDS Narrative: Other Relevant History:
43 2021-03-18 lymph node swelling, lymph node pain Painful swollen lymph node on left clavicle. Treatment has consisted of ice and naproxen. No change ... Read more
Painful swollen lymph node on left clavicle. Treatment has consisted of ice and naproxen. No change in outcome.
43 2021-03-18 lymph node swelling, peripheral swelling Swollen arm and swollen lymph nodes under left arm
43 2021-03-21 swelling Patient received Pfizer vaccine L Deltoid at 0950. At 1003 She complained of swollen, tingling, and... Read more
Patient received Pfizer vaccine L Deltoid at 0950. At 1003 She complained of swollen, tingling, and red hands b/l. No SOB, throat swelling, itching, scratching, no tongue swelling. AAO x 3. Talking with no difficulty. No known allergies. Benadryl 25 mg PO was administered. She was monitored. No further symptoms.
43 2021-03-22 lymph node swelling, swelling Left arm pain, swelling and swollen glands day of immunization. Left arm pain and limited mobility ... Read more
Left arm pain, swelling and swollen glands day of immunization. Left arm pain and limited mobility ongoing . (3 months now.)
43 2021-03-24 guillain-barre syndrome Guillain Barre Syndrome; POTS; Syncope; This is a spontaneous report from a contactable other hcp. A... Read more
Guillain Barre Syndrome; POTS; Syncope; This is a spontaneous report from a contactable other hcp. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 23Dec2020 07:30 (Batch/Lot Number: EH9899) as SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies as wine. Concomitant medication included loratadine (CLARITIN [LORATADINE]) 10 mg, as needed, daily for unspecified indication. On 23Dec2020 07:45 patient experienced Paresthesia tip of RIGHT little finger within 10 minutes of vaccine. Tachy arrhythmia, loss of function in RIGHT little finger/hand, and syncope 45 minutes after vaccine while driving. Tachycardia, hypertension, generalized weakness, and severe fatigue walking upstairs (persistent and worsened over several days). Loss of function/sensation RIGHT arm and RIGHT leg 8 days after vaccination. Symptoms persisted and worsened. Diagnosed with Guillain Barre Syndrome and POTS at follow up on 19Jan2021. She still have persistent weakness/paresthesias/neuropathy. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Dec2020. Seriousness criteria for all events was hospitalization.The events Guillan Barre syndrome and syncope were medically significant. Outcome of the event Guillain Barre Syndrome was recovering. Outcome of the other events was unknown.
43 2021-03-25 swelling face Extreme allergy reaction, hives in mouth and lips, eyes and nose itchy I want to tear my face off. L... Read more
Extreme allergy reaction, hives in mouth and lips, eyes and nose itchy I want to tear my face off. Lips and lower face are becoming more swollen. I have no access to Health insurance so I will take a shower and some Benadryl, my only attainable recourse at this time.
43 2021-03-26 lymph node swelling, lymph node pain By the next day, on the 26th I had mild injection site pain. During the night then between the 26th ... Read more
By the next day, on the 26th I had mild injection site pain. During the night then between the 26th and 27th a lymph node in the r. axilla became enlarged and sore. The entire r. arm is just achey other than the injection site pain and axillary discomfort. I do have a migraine as well, but I believe it is due to my mentrual cycle.
43 2021-03-26 peripheral swelling, axillary mass Swelling & itching: hands feet & throat Chills: with uncontrollable shaking Fever from 100-103 with... Read more
Swelling & itching: hands feet & throat Chills: with uncontrollable shaking Fever from 100-103 with Tylenol for 48 hours Extreme muscle pain- not ache, it hurt to lay still Bones would hurting, especially if pressure was applied to move or walk Shallow breathing Extreme thirst Sharp stabbing pain in head: bottom left toward back of neck Large Swollen spot under left arm under arm pit Increased heart rate- approx 130 bpm Went to emergency room in around 8:30 PM on Thursday March 25th. Was given via UV: fluids, Benedryl, medicine for pain & swelling. Discharged around 11:00 PM. Have Remained sick with normal side effects, feeling flu like, and a low temp around 100. Much more manageable. Today is Saturday & I still feel very unwell but no longer feel like I?m dying.
43 2021-03-26 swelling Fevers, Vomiting, Diarrhea, Migraines, Sinus, Wheezing, Wheezy Cough, Muscle and Joint Pain, Chills,... Read more
Fevers, Vomiting, Diarrhea, Migraines, Sinus, Wheezing, Wheezy Cough, Muscle and Joint Pain, Chills, Stomach and Chest Pains, Reflux and Heartburn, Flushing, Swelling/Edema, Dizzy, Lethargy, Brain-Fog// I?ve been trying to get diagnosed- have had some of these symptoms since September, but a couple/ few hours after the shot, I have been having all of those symptoms throughout the day and the ones I?ve had have been very-exacerbated; I?ve finally been able to hold down food.
43 2021-03-27 lymph node swelling Swollen lymph node under right arm almost immediately following injection, pain and soreness. Four d... Read more
Swollen lymph node under right arm almost immediately following injection, pain and soreness. Four days post vaccine, lymph node under am is still very swollen, pain and soreness down arm still present.
43 2021-03-27 oral herpes Massive cold sore outbreak 7 to 9 days after first shot
43 2021-03-28 lymph node pain, lymph node swelling On 3/20/2021 I received my annual mammogram. When leaving the facility, my left arm where I received... Read more
On 3/20/2021 I received my annual mammogram. When leaving the facility, my left arm where I received both vaccines started hurting the same as when I received both vaccines. By the end of the day I was not able to lift my arm above my head. I still have pain and swollen lymph nodes my left arm and near my left breast. I had swollen lymph nodes after 2nd vaccine which I received on 1/7/2021.
43 2021-03-28 lymph node swelling At the end of the first dose my Dr. ordered a CT scan for swollen Lymph nodes. The report from radio... Read more
At the end of the first dose my Dr. ordered a CT scan for swollen Lymph nodes. The report from radiology are showing enlarged lymph nodes located in the left side of my neck measuring at up 1.1 sonometers. They only found them on the left side where the vaccine was given. I was told to do self examinations and notify them if they get larger. I had a mild headache and soar arm after the vaccine.
43 2021-03-28 lymph node swelling There was some mild neck pain, almost like I slept wrong. I ended up with lymph nodes on the left si... Read more
There was some mild neck pain, almost like I slept wrong. I ended up with lymph nodes on the left side around my clavicle and base of my neck. You can feel them, small like dime size. I seen my Dr. and he ordered a CT scan.
43 2021-03-28 lymph node swelling Fever, chills, aches 18 hours after the shot. Swollen lymph node 24 hours after shot
43 2021-03-28 lymph node swelling Slight swelling, long lasting inflammation at injection site. Very swollen lymph node (5 days) unde... Read more
Slight swelling, long lasting inflammation at injection site. Very swollen lymph node (5 days) under arm on the side of the injection. Very painful (stabbing pain). General swelling of other lymph nodes as well, but less prominent. Fever starting 18 hours after second dose. Peak fever 101.7 from baseline of 98.4. Resolved in about 12-18 hours.
43 2021-03-29 lymph node swelling Tinnitus after 4 hours shot one. It went away after two weeks. Shot two it came back again. Golf ... Read more
Tinnitus after 4 hours shot one. It went away after two weeks. Shot two it came back again. Golf ball size knot in lymph nodes
43 2021-03-29 lymph node swelling Lymph node swelling in left arm pit Muscle aches (back)
43 2021-03-29 swelling Swelling, redness & itching at injection location. "Covid Arm"
43 2021-03-30 lymph node swelling swollen glands; Body aches; sores in mouth; Ear ache; pain swallowing; This is a spontaneous report ... Read more
swollen glands; Body aches; sores in mouth; Ear ache; pain swallowing; This is a spontaneous report from a contactable consumer (patient himself) of 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via unspecified roue of administration on 07Feb2021 at 11:30 AM (at the age of 43-years-old) in the right arm and first dose BNT162B2 (lot number: EM9809) via unspecified route of administration in the right arm on 21Jan2021 at 02:00 PM both as single dose of Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not having known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19 and Nasal swab and rapid antigen result was negative, On 13Feb2021. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not on any other medications within 2 weeks of vaccination. On 08Feb2021 at 02:00 AM, the patient experienced body aches, swollen glands, sores in mouth, earache, pain swallowing. No therapeutic measures were taken. The outcome of event was not recovered. Information on the lot/batch number has been requested.
43 2021-03-30 lymph node swelling Swelling of the lymph node in left axilla; This is a spontaneous report from a contactable nurse (pa... Read more
Swelling of the lymph node in left axilla; This is a spontaneous report from a contactable nurse (patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number:EK4176 Exp Date: not reported), via an unspecified route of administration on an unspecified date (at the age of 43-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. It was also reported that prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced swelling of the lymph node in left axilla on 27Jan2021. The patient has not been tested for COVID-19 since vaccination. The outcome of the event was not recovered.
43 2021-03-31 lymph node pain Headache started approximately an hour after the injection. Chills and fatigue started the next even... Read more
Headache started approximately an hour after the injection. Chills and fatigue started the next evening after the injection. Sore/painful armpit/lymph node under left arm (same side as injection) started 2 days after the injection. The headache and chills were relieved by Tylenol.
43 2021-03-31 peripheral swelling Headache for 2 days Stiff neck for 4 days Swollen legs from calves down, especially my left ankle.... Read more
Headache for 2 days Stiff neck for 4 days Swollen legs from calves down, especially my left ankle. Skin was tight & itchy. Swelling lasted for 2 days in right leg & 2 weeks in left leg
43 2021-04-01 lymph node pain 30 minutes after injection I felt tenderness in lymph nodes below my ears and then my face became to... Read more
30 minutes after injection I felt tenderness in lymph nodes below my ears and then my face became totally numb. I mostly felt the numbness in the sides of my face and chin. This lasted for approx 1 hour and did not return. I didn?t notice swelling.
43 2021-04-03 swelling angioedema; This is a spontaneous report from a contactable physician. A 43-year-old female patient ... Read more
angioedema; This is a spontaneous report from a contactable physician. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Mar2021 17:15 (at the age of 43years) as single dose for Covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. No known allergies. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced "uvula/soft palate/posterior oropharynx angioedema 5 days post vaccine" on 21Mar2021 (10:00AM). The adverse event resulted in Emergency room/department or urgent care. The patient was treated with Epinephrine, Benadryl, Solu-Medrol. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the available information and on the compatibility with the product's known safety profile, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of angioedema cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-04-03 swelling face Lip began tingling at 1PM. By 8PM that night, it was extremely enlarged. Face was swollen next day. ... Read more
Lip began tingling at 1PM. By 8PM that night, it was extremely enlarged. Face was swollen next day. Eyes and throat began swelling. Doctor told me to use the epipen on myself since I was salivating a lot. Called the ambulance and was taken to Hospital. Doctor told me that they thought the Lisinopril allergic reaction was activated. It is now Sunday (four days later) and I am experiencing muscle aches in my right arm and nerve pain in my right hand/fingertips. On Saturday, my right arm was twitching and cramping. Felt chills on Friday.
43 2021-04-03 swelling Lump in my neck, near my collarbone, on the side where the vaccine was administered. Visible and pai... Read more
Lump in my neck, near my collarbone, on the side where the vaccine was administered. Visible and painful to the touch.
43 2021-04-04 lymph node swelling Lymph node enlargement in throat beginning on day 5 and lasting until day 7 with underarm/breast inv... Read more
Lymph node enlargement in throat beginning on day 5 and lasting until day 7 with underarm/breast involvement as well Fatigue on day 6 Body/joint aches on day 6, lasting until day 9
43 2021-04-04 peripheral swelling My right upper arm, about four inches in diameter around the injection site, became swollen, hot, te... Read more
My right upper arm, about four inches in diameter around the injection site, became swollen, hot, tender and incredibly itchy. I attempted to control with oral benadryl for 24 hours, the redness grew and the itchiness remained intense. Topical benadryl with cold packs seemed to help temporarily. This lasted approximately 4 days. At that time the redness and swelling faded, giving way to bruising, and the itching has become less intense but still requires some topical benadryl at least twice per day. No blisters or open sores.
43 2021-04-04 swelling face I developed facial swelling approximately 3.5 weeks after the first injection. My eyelids swelled, a... Read more
I developed facial swelling approximately 3.5 weeks after the first injection. My eyelids swelled, and my cheeks and under eye area as well.
43 2021-04-05 peripheral swelling swollen feet occurred approximately 3 days after vaccine and have continued to stay swollen since. I... Read more
swollen feet occurred approximately 3 days after vaccine and have continued to stay swollen since. It's been 1 week since my dose 1 COVID vacination.
43 2021-04-05 swelling face 1004 RN responded to vehicle while pt in waiting lot after recipt of 1st dose Pfizer. C/O swelling ... Read more
1004 RN responded to vehicle while pt in waiting lot after recipt of 1st dose Pfizer. C/O swelling to nose. Denies difficulty breathing, denies chest pain. Monitored 30 minutes. RN noted no swelling to nose. Pt left lot approx 1035
43 2021-04-05 swelling Swollen extreme soreness itchy rash
43 2021-04-06 lymph node swelling On 4/4 at 2am, awoke to chest, arm, neck discomfort, naseau, dizziness, sweating, and chills. Resolv... Read more
On 4/4 at 2am, awoke to chest, arm, neck discomfort, naseau, dizziness, sweating, and chills. Resolved with Tylenol. Fatigue lasted through the day, and by evening body aches returned. On 4/5, peach pit-sized lymph node appeared above collar bone, pain in armpit and neck on right side, fatigue, and aches, along with continues and visible spasms in the neck. 4/7, symptoms still persist, with more swelling spreading across collar bone and into neck.
43 2021-04-06 lymph node swelling Headache-2 days Fever-8 hours Muscle ache-2 days (hip joint still feels achey almost a week later Fa... Read more
Headache-2 days Fever-8 hours Muscle ache-2 days (hip joint still feels achey almost a week later Fatigue-1 day Swollen lymph nodes in armpit and collar bone 3 days Tylenol taken as needed
43 2021-04-08 lymph node swelling SWOLLEN LYMPH NODES
43 2021-04-08 lymph node swelling Fever, chills, muscle ache, tired, headache, swollen arm pit, bruising at injection site
43 2021-04-08 oral herpes Exhaustion for a week Chronic itching for a week Yeast infection Cold sores
43 2021-04-08 peripheral swelling 7 hrs after injection, right Arm with injection swelled up from elbow to shoulder, and moderate pain... Read more
7 hrs after injection, right Arm with injection swelled up from elbow to shoulder, and moderate pain in arm and neck muscle aches. 24 hrs after injection, swelling also occurred in opposite (left) arm, but subsided in injection (right) arm. After 48 hrs of vaccination, swelling is almost gone, but still mild aches in neck and left arm.
43 2021-04-10 swelling face Facial and throat swelling , headache, tiredness Rapid heartbeat, weakness, Wheezing Chills Sweated... Read more
Facial and throat swelling , headache, tiredness Rapid heartbeat, weakness, Wheezing Chills Sweated through 2 outfits Joint and muscle pains
43 2021-04-11 anaphylactic reaction Anaphylaxis, acute respiratory distress, mild tongue edema
43 2021-04-11 swelling face Felt numbness in face the night after receiving first dose as well as the morning after that. Numbn... Read more
Felt numbness in face the night after receiving first dose as well as the morning after that. Numbness left and then moved to swelling, particularly above the eyes, which is more subtle now but ongoing as of 4/12/21.
43 2021-04-12 lymph node pain Received the vaccine at 12 on April 10th. Went to sleep around 11pm that night feeling pretty normal... Read more
Received the vaccine at 12 on April 10th. Went to sleep around 11pm that night feeling pretty normal and after taking one dose of acetaminophen, just in case as I've been told may people were experiencing high fevers after the 2nd dose. Woke up at 2am with high fever (sorry, never actually took my body temp), chills, uncontrollable body shakes, body aches and extreme nausea. Went back to sleep around 5am. Woke up around 10am on April 11th with 99.9 body temp. Took more acetaminophen and ibuprofen to control the body aches and fever. Spent the day in bed on April 11th, with very little appetite and flu like symptoms. Gotten progressively better throughout the day but never felt quite right. On April 12th, was still feeling tired and had some muscle aches but was overall feeling much better. Noticed the lymph nodes under my left armpit (I received the vaccine in the left arm) were quite tender to the touch. Was able to resume normal activities but didn't feel like I was quite ready to go to the gym. On April 13th, feeling normal, finally, aside from the tenderness of the lymph nodes (left armpit).
43 2021-04-13 peripheral swelling 4/7-4/8: 101.8 fever 4/9 through current day: Autoimmune reaction - fingers are sore, swollen, itchy... Read more
4/7-4/8: 101.8 fever 4/9 through current day: Autoimmune reaction - fingers are sore, swollen, itchy, white and red, cold and hot. Treatment: Dr. visit on 4/13, prescribed prednisone and nifedipine to reduce/relieve inflammation and constricted blood vessels in fingers. Time course: 4/9/21 through current day
43 2021-04-13 swelling face Swelling of face, pounding headache, chills, muscle weakness and soreness, burning sensation in thro... Read more
Swelling of face, pounding headache, chills, muscle weakness and soreness, burning sensation in throat, itchy
43 2021-04-14 anaphylactic reaction Mild/moderate anaphylactic reaction lasting about 45 minutes, trouble swallowing, fast pulse, disori... Read more
Mild/moderate anaphylactic reaction lasting about 45 minutes, trouble swallowing, fast pulse, disorientation, tight throat. Epinephrine not used.
43 2021-04-14 lymph node swelling I have a very swollen lymph node under my arm, I have had fevers of 100.0 since Tuesday. Today I am... Read more
I have a very swollen lymph node under my arm, I have had fevers of 100.0 since Tuesday. Today I am also feeling very dizzy and I have a general feeling of malaise.
43 2021-04-14 lymph node swelling Painful swollen lump the size of a pea just above left collar bone (same side as vaccine shot in arm... Read more
Painful swollen lump the size of a pea just above left collar bone (same side as vaccine shot in arm).
43 2021-04-14 peripheral swelling Hives within 3 hrs, swollen stiff arm, fatigue next day took Allegra allergy med extra dose
43 2021-04-14 swelling face Pain and swelling lips, and several areas of the face (swelling and pain in lips, pain only in face)... Read more
Pain and swelling lips, and several areas of the face (swelling and pain in lips, pain only in face) both sites, only where she has had filler (filler name unavailable Restylene or Juvaderm??).
43 2021-04-16 lymph node swelling, lymph node pain Low grade fever, chills, fatigue, arm soreness, visibly swollen armpit under left arm. Armpit pain b... Read more
Low grade fever, chills, fatigue, arm soreness, visibly swollen armpit under left arm. Armpit pain began approx 36 hours after receiving injection. Other symptoms began approx 20 hours after receiving injection. Armpit pain was present after first injection but at the time did not realize it was related to vaccine until symptoms appeared more severely after second dose.
43 2021-04-16 lymph node swelling Dry heaving for 4 hours (2 am to 6 am) then fever chills and severe joint pain for next 13 hours. Sw... Read more
Dry heaving for 4 hours (2 am to 6 am) then fever chills and severe joint pain for next 13 hours. Swollen lymph nodes in arm pit area until day 5 after injection
43 2021-04-16 swelling face Swelling under both eyes, first noticed when I woke up the morning after vaccine, gradually decrease... Read more
Swelling under both eyes, first noticed when I woke up the morning after vaccine, gradually decreased over the next few days; swelling left cheek, gradually decreased over the next week; chest tightness, started the day after vaccine, intermittent throughout day, decreased in frequency & severity 8 days post vaccine. Currently 14 days post vaccine and still have mild chest tightness, intermittent throughout day.
43 2021-04-16 swelling headache; swelling in left armpit; difficulty sleeping; fever; fatigue; body aches; sweating; This i... Read more
headache; swelling in left armpit; difficulty sleeping; fever; fatigue; body aches; sweating; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received second dose of bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6201) via an unspecified route of administration, administered into left arm on 12Feb2021 08:45 (at the age of 43-year-old) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Patient was not pregnant. It was also reported that the patient was taking unspecified concomitant medications. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249) administered into left arm on 22Jan2021 08:30 AM (at the age of 42-year-old) for COVID-19 immunization. On 12Feb2021 14:00, patient experienced headache, swelling in left armpit, difficulty sleeping, fever, fatigue, body aches and sweating. The patient did not receive treatment for the events reported. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 01Feb2021. Outcome of events was not recovered.
43 2021-04-17 lymph node swelling broke out with hives on her face and hands; Swollen lymph nodes in throat; This is spontaneous repor... Read more
broke out with hives on her face and hands; Swollen lymph nodes in throat; This is spontaneous report received from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in left arm on 25Mar2021 16:30 (Batch/Lot Number: ER8732) (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included benign brain tumor removal, seizures (previous seizures prior to surgery), penicillin (PCN) allergy and sulfa drugs allergy. Concomitant medications included topiramate (TOPAMAX), eletriptan hydrobromide (RELPAX), ergocalciferol (VITAMIN D) and ascorbic acid (VITAMIN C), all were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient broke out with hives on her face and hands and had swollen lymph nodes in throat on 27Mar2021 08:00. The patient went to emergency room/ department or urgent care due to the events, broke out with hives on her face and hands and swollen lymph nodes in throat. The patient received antihistamine as the treatment for the events, broke out with hives on her face and hands and swollen lymph nodes in throat and the patient was also offered steroid but she declined it. The outcome of events, broke out with hives on her face and hands and swollen lymph nodes in throat, was recovering. No follow-up attempts are needed. No further information is expected.
43 2021-04-19 anaphylactic reaction, swelling Went to doctor diagnosed with anaphylactic angioedema.
43 2021-04-20 lymph node swelling Pfizer-BioNtech COVID-19 Vaccine EUA. Swollen lymph node,s in the same side as the vaccine was appl... Read more
Pfizer-BioNtech COVID-19 Vaccine EUA. Swollen lymph node,s in the same side as the vaccine was applied, in the lower neck and perhaps armpit.
43 2021-04-20 swelling Redness, soreness swelling at injection site. Small quarter size rash on right thigh.
43 2021-04-21 lymph node swelling Systemic: Lymph Node Swelling-Mild
43 2021-04-21 peripheral swelling 5 days after both the first shot and the last shot, I had sever lower leg swelling and pain so much ... Read more
5 days after both the first shot and the last shot, I had sever lower leg swelling and pain so much so that I went to Urgent Care to get scanned for blood clots. I did not have blood clots. The pain and swelling lasted for almost a week after the first shot. I am on onset of the swelling for the 2nd shot.
43 2021-04-22 lymph node pain, lymph node swelling Lymph node swollen and tender on left side of neck above the collarbone.
43 2021-04-22 lymph node swelling Mild soreness of arm after shot. Sore throat starting on Wednesday the following week (6 days after ... Read more
Mild soreness of arm after shot. Sore throat starting on Wednesday the following week (6 days after injection) along with headache and swollen lymph nodes in neck/throat on Thursday night (7 days after injection). Still persisting on Friday morning and getting worse as I am typing this.
43 2021-04-22 lymph node swelling Fatigue, for 3 days. Swollen glands under left armpit and in left side of neck 5 days after vaccine ... Read more
Fatigue, for 3 days. Swollen glands under left armpit and in left side of neck 5 days after vaccine administration. Glands started to burn for about 36 hours. Burning went away and remained swollen. 15 days after left arm became sore around injection.
43 2021-04-22 swelling face Face and lip swelling. Tightness in throat under jaw. Went to Urgent Care 3 days later, prescribed S... Read more
Face and lip swelling. Tightness in throat under jaw. Went to Urgent Care 3 days later, prescribed Steroids.
43 2021-04-22 swelling Large fist size welt with lump. Red and hot to the touch
43 2021-04-23 lymph node swelling severe chills, teeth chattering; shaking; sweating; swollen lymph nodes; severe intense pain; headac... Read more
severe chills, teeth chattering; shaking; sweating; swollen lymph nodes; severe intense pain; headache; fatigue; vomiting; nausea; This is a spontaneous report from a contactable other HCP (reported herself). A 43-year-old female patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via unspecified route of administration in left arm on 16Feb2021 at 13:00 as single dose for COVID-19 immunisation. The patient was not pregnant. The patient medical history was not reported. There were no known allergies. The concomitant medication included Zoloft from an unknown date for unknown indication. There was no COVID prior vaccination. There were no other vaccines in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in left arm on 25Jan2021 at 08:00. On 16Feb2021 at 23:00, the patient experienced severe chills, teeth chattering, shaking, sweating, swollen lymph nodes, severe intense pain, headache, fatigue, nausea and vomiting. Therapeutic measures were not received for the events. COVID was not tested post vaccination. The outcome of the events were recovering. Information on the lot/batch number has been requested.
43 2021-04-23 lymph node swelling Swelling of lymph node in back of the head after 4 days, went away, then autoimmune reaction which c... Read more
Swelling of lymph node in back of the head after 4 days, went away, then autoimmune reaction which consisted of swollen lymph nodes in back of head, unable to move neck, unable to lay head down to sleep, headaches
43 2021-04-23 swelling face Cheek swelling on left side of face. With numbing of lip due to swelling; Cheek swelling on left sid... Read more
Cheek swelling on left side of face. With numbing of lip due to swelling; Cheek swelling on left side of face. With numbing of lip due to swelling; Cheek swelling on left side of face. With numbing of lip due to swelling; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: El3302), via an unspecified route of administration in left arm on 13Jan2021 10:00 as single dose and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: En5318) via an unspecified route of administration in left arm on 04Feb2021 11:00 as single dose for COVID-19 immunization. Patient age was 43-years-old and was not pregnant at the time of vaccination. Vaccine was administered at the military facility. Patient medical history included sleep apnoea syndrome. The patients concomitant medication included melatonin taken for an unspecified indication, start and stop date were not reported. The patient experienced cheek swelling on left side of face with numbing of lip due to swelling with numbing of lip due to swelling on 25Jan2021. No other vaccine in four weeks. Emergency room/department or urgent care. No COVID prior vaccination. No covid tested post vaccination. Therapeutic measures were taken as a result of the event. The outcome of the events was recovering.
43 2021-04-24 lymph node swelling tightness in chest; joint pain; headache; nausea; swollen lymph nodes; fatigue; itchy eyes; bacteria... Read more
tightness in chest; joint pain; headache; nausea; swollen lymph nodes; fatigue; itchy eyes; bacterial vaginosis; This is a spontaneous report from a contactable consumer. A 43-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 13Feb2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included amlodipine besilate (AMLODIPINE BESILATE) taken for an unspecified indication,phentermine (PHENTERMINE) taken for an unspecified indication,metoprolol tartrate (METOPROLOL TARTRATE) taken for an unspecified indication, ascorbic acid (VIT C) taken for an unspecified indication, ergocalciferol (VIT D) taken for an unspecified indication. The patient experienced bacterial vaginosis with outcome of recovering. The patient had tightness in chest, joint pain, headache, nausea, swollen lymph nodes, fatigue, itchy eyes on 09Feb2021 with outcome of recovered. Information on the lot/batch number has been requested.
43 2021-04-24 peripheral swelling, lymph node swelling swelling of her left arm; Puffy hand; Swollen lymph nodes under her arm; Injection site sore; This i... Read more
swelling of her left arm; Puffy hand; Swollen lymph nodes under her arm; Injection site sore; This is spontaneous report received from a contactable consumer. A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: ER8727 and expiry date was not provided), via an unspecified route of administration, in the left arm, on 20Mar2021 (at the age of 43-years-old) as a single dose for covid-19 immunization. Patient's medical history included: Type 1 Diabetes (ongoing, diagnosed when she was 8 and illness at time of vaccination) and high Blood pressure (diagnosed last year in Mar or Apr, but is not sure). Family Medical History included: Father's family has diabetes and mother's family has history of high blood pressure. Concomitant medications included: insulin (ongoing); insulin glargine (BASAGLAR) (ongoing), insulin glargine (LANTUS); all for type 1 diabetes (takes insulin after every meal) and one or two blood pressure medications. As reported no additional vaccines administered. Patient had no prior vaccinations within 4 weeks. The patient experienced injection site sore on 21Mar2021, swollen lymph nodes under her arm on 29Mar2021, swelling of her left arm and puffy hand on 30Mar2021. Patient went to doctor's office on 01Apr2021 for the swollen arm and the lymph nodes. Patient underwent ultrasound on unspecified date and result was swollen lymph nodes. The outcome of injection site sore was recovered on 27Mar2021, outcome of swollen lymph nodes under her arm was unknown, outcome of swelling of her left arm was recovered (on an unspecified date in 2021) and outcome of puffy hand was recovering. No follow-up attempts are possible. No further information is expected.
43 2021-04-26 swelling face mild facial swelling started within half hour of vaccine. continued for at least 4 days afterward. c... Read more
mild facial swelling started within half hour of vaccine. continued for at least 4 days afterward. crusty eyes on saturday after doing yard work.
43 2021-04-27 axillary mass RASH OR LUMP UNDER ARMPIT OF RIGHT ARM; LASTED FOR 2-3 DAYS DISCOMFORT IN LEFT ARMPIT FOR 1-2 DAYS
43 2021-04-27 lymph node pain After first dose on 3/25/21, I experienced an intense headache within a few hours and sore arm at in... Read more
After first dose on 3/25/21, I experienced an intense headache within a few hours and sore arm at injection site, both subsided. I started my menstrual cycle two days later. Then 10 days later, I started spotting (very unusual for me) and had another menstrual cycle a few days after that. This resulted in two cycles within 21 days, which is also very unusual for me. After the second vaccination on 4/15/21, I experienced body aches and a fever within 12-36 hours from injection. I also experienced soreness in my right breast and lymph node above the breast (now 13 days post-vaccination and this has not subsided). I also had an episode of vertigo lasting 12 hours on the 10th day after the second vaccination.
43 2021-04-27 lymph node swelling Vaccine administered 4/23/2021 approx. 3:30pm. Work up next morning (4/24) at approximately 7:30am ... Read more
Vaccine administered 4/23/2021 approx. 3:30pm. Work up next morning (4/24) at approximately 7:30am with headache. Also had body achiness, low grade fever and chills. These progressed throughout the day and were the worst around 3:30pm (24 hours after injection). Used Tylenol and drank lots of water. These symptoms disappeared by Sunday morning (4/25). However, on Sunday and Monday (4/25/-4/26), I had a swollen lymph node under my right arm, where I received the injection. It was painful. The lymph node went down in size starting on 4/27 and had disappeared entirely that day.
43 2021-04-27 lymph node swelling Next morning (4/27/2021) after receiving the shot (@ approx. 8:00 AM), tenderness was felt in the le... Read more
Next morning (4/27/2021) after receiving the shot (@ approx. 8:00 AM), tenderness was felt in the left armpit (same side shot was received). After examining armpit with fingertips, I felt what appears to be swollen lymph nodes.
43 2021-04-27 swelling face Still swollen, taking Benadryl, Tylenol. Fatigued and achy but feeling better 48 hours after init... Read more
Still swollen, taking Benadryl, Tylenol. Fatigued and achy but feeling better 48 hours after initial vaccination
43 2021-04-28 swelling She got her vaccine, she had no side effects other than her mouth being really really dry. She went... Read more
She got her vaccine, she had no side effects other than her mouth being really really dry. She went to bed, and was awakened at 3:00 AM with ringing in her ears. She is living on 3 hours of sleep a day due to the persistent ringing in the ears. She went to the tinnitus center who gave her some medication for the swelling and to wait and see if it goes away or if this is permanent. Right now she is very upset that the public is not being informed of this information.
43 2021-04-29 lymph node pain, lymph node swelling Right at 24 hours I experienced chills and body aches, but noticed when I woke up the next morning t... Read more
Right at 24 hours I experienced chills and body aches, but noticed when I woke up the next morning that the lymph nodes in my right armpit are were swollen to about the size of a small clementine orange. They lymph nodes are still very swollen and tender. It hurts to simply let my arm rest on the side of my body.
43 2021-04-29 peripheral swelling Within a minute of administering vaccine both of patient's hands began to swell and turn bright red ... Read more
Within a minute of administering vaccine both of patient's hands began to swell and turn bright red but no reports of itchiness and otherwise patient was fine and did not report any other symptoms suggesting a systemic allergic reaction. Oral Benadryl was administered and patient was monitored for 30 minutes with no issues and no worsening symptoms, though the swelling and redness did not go down during that time. Patient mentioned a similar reaction happened after her 1st dose and that the swelling and redness took several hours to return to normal and that a similar reaction happens when she eats strawberries. Patient left on her own after 30 minutes (could not require her to stay) stating she was fine.
43 2021-04-30 lymph node swelling App. Fifteen minutes after shot right arm feels heavy and numb. Stomach feels weak and tighten as i... Read more
App. Fifteen minutes after shot right arm feels heavy and numb. Stomach feels weak and tighten as if I'm about to have Diarrhea. During the course of the evening symptoms progress. Fatigue, increase SOB, feeling head expanding and heavy, throat tighten- constantly waking me up whiIe I grasp for breath, uncontrollable movement of the body, heavily congested. Symptoms continues - Saturday chest pain, both breast and severe body pain, lymph nodes swollen underarms and side of right breast. Feeling really horrible
43 2021-04-30 lymph node swelling 4/28/21 (first day after) headache and achey 4/29/21 (second day) Severe Swollen tongue, I took two... Read more
4/28/21 (first day after) headache and achey 4/29/21 (second day) Severe Swollen tongue, I took two 25mg benadryl and swelling subsided after 2.5 hours, 4/30/21 (third day) swollen tongue for 1.5 hours, took two 25mg benadryl, and after that subsided, my throat got swollen and neck/glands swollen, ....I took two more 25mg benadryl 5/1/21 f(ourth day after vaccine - today) tongue again began to swell (not as severely) and slight swelling around lips and took two 25mg benadryl which does help
43 2021-04-30 peripheral swelling problem with her cholesterol; pain on the top of my head and my hands hurt/headache; pain on the top... Read more
problem with her cholesterol; pain on the top of my head and my hands hurt/headache; pain on the top of my head and my hands hurt; Nauseous; my hands and feet started going numb; they itch they burn; feet are painful; uncomfortable; blood clot/a clot or something in her legs; from the knees down I was having a lot pain/leg pain felt like it is really deep in the vein; she thought she was having a stroke; cramps; burning from my calf to my feet; pain in her neck then to her back; pain in her neck then to her back; different temperatures like hot and cold make it bad and irritating; can't sleep well because of her symptoms; Swelling in her Feet; can't think right; This is a spontaneous report from a contactable consumer. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in the right arm in the morning of 01Apr2021 (Batch/Lot Number: ER8727) as a single dose for COVID-19 immunization. Medical history included ongoing complex regional pain syndrome, ongoing fibromyalgia, ongoing arthritis - all diagnosed 20 years ago. Her mother has lupus and rheumatoid arthritis and she can't have the vaccine, states she doesn't know if something could be genetic. Low potassium in the past and stated that she has a lot of allergies to medications, but she consulted with the pharmacist and he said it would be okay. There were no concomitant medications. No additional vaccine was administered on the same date of BNT162B2 and no prior vaccination within four weeks. The patient was having weird symptoms and she tried looking online and in different groups to find out if anyone has similar symptoms, but she hasn't been able to find anything. She began by saying she has health issues; she has Fibromyalgia and Complex Regional Pain Syndrome. She doesn't know if studies were performed on patients with those disorders that took the vaccine. It's been about 3 weeks since getting the vaccine (Apr2021) and she started having symptoms that she thought could be a blood clot. From the knees down, she was having a lot of pain, cramps, burning from her calf to her feet. She would keep rubbing them and massaging them. It was excruciating pain. She was having symptoms and she did go see her Nurse Practitioner on 14Apr2021 because she thought she was having a stroke or a clot or something in her legs or that she was having a problem with her cholesterol. The nurse thought maybe it was her electrolytes, because she had low potassium in the past, but everything came back normal. Her feet were painful but not as bad in Apr2021. She felt like her condition but it's flaring up like 200% it's like over a 10 on the pain scale. She can't think right, she can't work, and was very uncomfortable in Apr2021. The leg pain felt like it is really deep in the vein, it doesn't feel like it is superficial, and she can feel stuff or liquid flowing. Her pain alternates from her head to her neck to her feet and it is very uncomfortable. Her hands and feet started to go numb, not completely numb but like when they fall asleep from sitting on them and then hit something and it hurts. Her arms were burning like crazy; they itch, they burn in Apr2021. Different temperatures like hot and cold make it painful, bad and irritating, and she can't sleep well because of her symptoms. She doesn't know the exact dates, but it has been about a week, but it is changing. It started with cramps in her legs from her knees down. That is where she had injuries and she thought it was her cholesterol. From her knees down, she has cramps and pain and it is very uncomfortable, she felt a really deep pain. She has pain in her neck then to her back, it started in her lower extremities and it is going up. It has stayed the same and she has to keep taking Tylenol to control the pain. Her symptoms got worse and she started taking Tylenol and that helped and then on 15Apr2021, her hands and feet started going numb and she had a headache and pain on the top portion of her head (reported as brain) and her hands hurt, and she was nauseous. She hasn't heard back from the nurse practitioner, so she decided not to go and get it done because she felt it is from the vaccine. She also has swelling of feet in Apr2021, and now she just woke up an hour ago and she slept somewhat okay, but she had to take Tylenol. Now that she is standing, it felt like her legs are starting to hurt again. Treatment included Tylenol, which helps a little and she has to keep taking it. If she doesn't take Tylenol, she can't even function. The events from the knees down I was having a lot pain/leg pain felt like it is really deep in the vein, cramps, my hands and feet started going numb, they itch they burn, feet are painful, uncomfortable, pain on the top of my head and my hands hurt/headache, swelling in her feet, nauseous, pain in her neck then to her back, different temperatures like hot and cold make it bad and irritating had not resolved, while the event can't sleep well because of her symptoms was resolving, and the outcome rest of the events was unknown.
43 2021-05-02 lymph node swelling Instant burning lungs for 12 hours with arm soreness, next day nerve pain in left leg (chronic back ... Read more
Instant burning lungs for 12 hours with arm soreness, next day nerve pain in left leg (chronic back and S/I issue, weak leg), then on Thursday, 48 hrs later, left underarm lymph node swelled, left neck swelled and left half facial numbness. Friday, I called Dr, they transferred me to hospital nurse who insisted I see the dr immediately. Dr did neuro exam and decided since I have blood clot history to send me to ER for a scan. At ER, dr was unsure of what to do or why I was there and sent me home. They just did a basic blood panel before I ever saw the dr. Burning lungs returned on sunday morning and facial numbness increased.
43 2021-05-02 swelling face itching, dizziness and facial swelling sensation. Given PO benadryl. Advise going to ER given persis... Read more
itching, dizziness and facial swelling sensation. Given PO benadryl. Advise going to ER given persistent itching and feeling her lips and face were swollen and numbness. Normal exam. Patient refused 911 or driving to eR, wants to go home and observe herself for a while
43 2021-05-03 c-reactive protein increased Acute HFrEF (35%) and dilated cardiomyopathy. Potential myocarditis. MRI cardiac obtained 24 days po... Read more
Acute HFrEF (35%) and dilated cardiomyopathy. Potential myocarditis. MRI cardiac obtained 24 days post vaccination neg for acute myocarditis. Other work up cardiomyopathy: ischemia (underwent left heart cath), HIV, TSH neg. No hx of alcohol, meth, or cocaine. Not acutely infected.
43 2021-05-03 lymph node pain, lymph node swelling On 5/2 I woke up to a large red circle inside of my armpit that burned on the same side of my vaccin... Read more
On 5/2 I woke up to a large red circle inside of my armpit that burned on the same side of my vaccination. My lymph nodes were extra red and itchy. I tried icing and taking benadryl that day and resting but later in the day presented with hives that day. I didn't sleep that night due to the itching and pain in my nodes. I saw a telehealth Dr on Monday 5/3 who advised me to visit an immediate care or ER due to concerns of past DVT. I proceeded to Er my vitals were taken, monitored pulse and connected to monitor for heart no other tests. Dr determination based on history and presentation that the reaction was a latent reaction to the vaccine. I was given 60 mgs of prednisone at the hospital, 60 day after and have been reduced to 40 until Friday 5/7. I am also to take up to 3 benadryl as needed per day for itching. I have follow up with my pcp on Monday 5/10.
43 2021-05-03 lymph node pain, lymph node swelling Low grade fever starting around 11 hours after injection rising to 102 by 13 hours after. Back to l... Read more
Low grade fever starting around 11 hours after injection rising to 102 by 13 hours after. Back to low grade by morning. Swollen and tender gland in armpit starting about 36 hours after injection.
43 2021-05-03 swelling face Facial swelling, redness, burning/pain started 24 hours after injection and has not resolved itself ... Read more
Facial swelling, redness, burning/pain started 24 hours after injection and has not resolved itself 9 days later. Other common reactions (nausea, joint pain, chills, fatigue) started at the same time, and have since mostly resolved itself except I'm still experiencing fatigue and tiredness.
43 2021-05-04 lymph node swelling Lymph node near armpit swollen and red, hard and painful to the touch. Left side, same as the inject... Read more
Lymph node near armpit swollen and red, hard and painful to the touch. Left side, same as the injection site. My doctor knows, we are monitoring it for any changes. The lymph swelling was acute, and I was alarmed, until I read that this may be one of the side effects.
43 2021-05-04 oral herpes Cold sore on lip. After 2nd shot. Sore right breast
43 2021-05-04 peripheral swelling Joint pain in all joints, most severe in my right wrist; numbness in feet; swelling in fingers and i... Read more
Joint pain in all joints, most severe in my right wrist; numbness in feet; swelling in fingers and in toes
43 2021-05-05 lymph node swelling Day 2-4 swollen glands in left side of neck Days 6-8 104 fever, chills, extreme body aches, vomiting... Read more
Day 2-4 swollen glands in left side of neck Days 6-8 104 fever, chills, extreme body aches, vomiting, diarrhea, headache, cough, abdominal pain when I cough.
43 2021-05-07 lymph node swelling Swelling and soreness in right armpit
43 2021-05-09 lymph node swelling Swollen lymph nodes under right arm close to chest, in armpit area. Very large!!! Very painful. Sore... Read more
Swollen lymph nodes under right arm close to chest, in armpit area. Very large!!! Very painful. Sore throat guessing enlarged lymph nodes as well. Very Achy joints all over body, especially legs.
43 2021-05-09 lymph node swelling Swollen lymph node in left armpit.
43 2021-05-09 peripheral swelling Persistent swelling of the feet and legs for approximately 10 days. Foot skin very sensitive to the ... Read more
Persistent swelling of the feet and legs for approximately 10 days. Foot skin very sensitive to the touch, mild pain and itchiness.
43 2021-05-09 peripheral swelling SWELLING OF FEET AND LEFT EYE. HIVES AROUND RIGHT EYE, LEFT FOREARM, AND LEFT JAW. PATIENT HAS BE... Read more
SWELLING OF FEET AND LEFT EYE. HIVES AROUND RIGHT EYE, LEFT FOREARM, AND LEFT JAW. PATIENT HAS BEEN TAKING BENADRYL AND USING A COLD COMPRESS. SYMPTOMS HAVEN'T RESOLVED, BUT HAVE REMAINED STEADY WITHOUT WORSENING. PATIENT REPORTS NOT HAVING A PCP. I ADVICED HER TO AT LEAST GO TO URGENT CARE FOR A CHECK-UP FOR HELP RESOLVING REACTION.
43 2021-05-10 swelling face Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient recei... Read more
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient received Pfizer covid vaccine, experienced some lip swelling on the way home and stopped by another pharmacy and was given 2 pills of benadryl 25mg. Swelling went down, patient is fine. Reported by pharmacy manager.
43 2021-05-11 lymph node swelling, peripheral swelling On Sunday May 9th, I experienced a fever, chills, body ache, nausea, and headache from about 8am thr... Read more
On Sunday May 9th, I experienced a fever, chills, body ache, nausea, and headache from about 8am through 8pm. Then on Monday May 10th my left armpit (arm of both shots) was swollen and very painful. The pain has subsided a bit but is still uncomfortable today (5/12/2021). I read online it can take 4 weeks for swollen lymph nodes to fully recover.
43 2021-05-11 white blood cell count increased, lymph node swelling breathing labored while walking or doing activity; swollen lymph nodes/ lymph nodes were enlarged sl... Read more
breathing labored while walking or doing activity; swollen lymph nodes/ lymph nodes were enlarged slightly; fluid built up around heart and lungs; fluid built up around heart and lungs; white blood count was elevated; heart was weak and only working at 29% percent; heart was weak and only working at 29% percent; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 13Feb2021 at 18:00 (at the age of 43 years old) (Lot Number: EM9809, unknown expiration) as 2nd dose, single for COVID-19 immunization. Medical history included penicillin allergy. There were no concomitant medications. The patient also received first dose of BNT162B2 on 23Jan2021 at 18:00 (at the age of 43 years old) (lot number: EL3247, unknown expiration) in left arm for COVID-19 immunization. After the second shot, the patient did notice swollen lymph nodes on 02Apr2021 for several days. She noticed her breathing labored while walking or doing activity on 02Apr2021 after getting the second shot. In 8 weeks, the patient went to the ER and found that she had fluid built up around heart and lungs which started on 02Apr2021. They also found in a CT scan that lymph nodes were enlarged slightly and that the patient's white blood count was elevated on 02Apr2021. After an echocardiogram on 02Apr2021, they determined that the patient's heart was weak and only working at 29% percent. The patient has had no prior history of heart problems or was taking any medications. The patient was given many heart medications to strengthen the heart and treatment for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID and was not diagnosed with COVID prior to vaccination. The patient was tested for COVID via nasal swab on 10Apr2021 with negative result. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown. The events were assessed as serious (hospitalization) for 8 days. No follow-up attempts are needed. No further information is expected.
43 2021-05-12 white blood cell count increased Patient had received covid vaccine, and had been monitored her full fifteen minutes. Time ended at 1... Read more
Patient had received covid vaccine, and had been monitored her full fifteen minutes. Time ended at 11:56. Left facility, voicing no concerns and reentered building at 12:13, complaining of hives. Alert, oriented, and not in any acute distress. Hives noted to bottom of chin, neck and chest area. 12: 15 Brought to cot area, where I was met by. Patient stated she had a reaction to first vaccination so had already taken a Benadryl 25mg this am at 9:45. She also had taken a dose of Benadryl after leaving facility at noon. Total dose 50mg. Blood pressure 182/118 hr 145, r 22 sat 98%. Explained unable to give Benadryl as already had taken max dose for 4 hours, and unable to give epi since b/p and hr so high. 12:15 contacted EMS per protocol. 12:20 vitals 188/110 hr 128 r 20 sat 98%, hives remained unchanged, raised red present to neck, under chin and on chest. 12:24 ems arrived. care assumed by paramedic. Patient transported to ED
43 2021-05-14 lymph node swelling Lymph nodes in left armpit swollen to grapefruit size; This is a spontaneous report from a contactab... Read more
Lymph nodes in left armpit swollen to grapefruit size; This is a spontaneous report from a contactable consumer. A 43-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), dose 2 via an unspecified route of administration on 13Feb2021 at 08:45 (at the age of 43-year-old) as 2ND DOSE, SINGLE in left arm for COVID-19 immunization. The patient's medical history included a known allergies of Peas, apples, pork. Patient was not pregnant at the time of vaccination. Concomitant medications included Zoloft. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 23Jan2021 at 10:30 AM (at the age of 43-year-old) as single dose in left arm for COVID-19 immunization. On 14Feb2021, the patient's lymph nodes in left armpit swollen to grapefruit size, making it difficult to use that arm/shoulder. The patient did not receive any treatment for the event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event was not recovered. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
43 2021-05-14 swelling Within 2-3 minutes of receiving shot, I felt "not present" and detached from my body. "Unreal" feeli... Read more
Within 2-3 minutes of receiving shot, I felt "not present" and detached from my body. "Unreal" feeling, worse than recovering from nitrous oxide and Novocain after dental surgery. Five minutes after shot, the left side of my face became tingly and swollen - from my chin, lips, eye socket, up to my scalp. Tingle and numbness spread to entire back of my head and down the whole left side of my body. This sensation lasted approximately 30 minutes. At 15 minutes, I was checked by a paramedic for hives, tongue swelling and my oxygen level (oximeter). They did not administer any medicine to counteract. They observed me for another 15 minutes and sent me home with instructions to take Benadryl and a nap. Unable to drive myself home. I slept for 3 hours. Was lethargic and exhausted.
43 2021-05-15 lymph node swelling 4/24/21 - low grade fever, chills, body aches, joint pain, fatigue, 4/25/21 - low grade fever, chill... Read more
4/24/21 - low grade fever, chills, body aches, joint pain, fatigue, 4/25/21 - low grade fever, chills, body aches, joint pain. fatigue, 4/26/21 - swollen left arm pit lymph nodes, fatigue, 4/27/21 - swollen left arm pit lymph nodes, fatigue, 4/28/21 - swollen left arm pit lymph nodes, fatigue, 4/29/21 - feeling better and tried a little workout, 4/30/21 - chest pain begins, mostly left-hand side, when I breathed deeply, fatigue beginning, 5/1/21 - chest pain increases, breathing deeply uncomfortable, 5/2/21 - chest pain increases enough that I call advice nurse to find out if need to be seen, 5/3/21 - visit Health Emergency Dept, chest pain increased, breathing deeply more painful, fatigue, 5/4/21 - chest pain increased, breathing deeply much more painful, more fatigue, 5/5/21 - found leaning forward feels better to breath. Chest pain lessens, 5/6/21 - virtual dr appt, chest pain subsiding more, by evening feeling much better, 5/13/21 - had in person follow up, here is her summary: Went to ER with pleuritic chest pain that worsened with lying supine and improved with leaning forward. Took ibuprofen and tylenol alternating and pain subsided and resolved last Thursday. Had CT angiogram and ECG in hospital, negative except mild left sided atelectasis. Occurred after booster of COVID-19 vaccination. Breast cancer patient on tamoxifen. No ST elevation on ECG.
43 2021-05-16 peripheral swelling Patient began to feel itchy beginning in left upper arm at approximately 4:00PM on 5/8/2021. throug... Read more
Patient began to feel itchy beginning in left upper arm at approximately 4:00PM on 5/8/2021. throughout the next several days the itchiness was accompanied by small hives and has progressed through patients arms, legs, torso , neck, and now head including ears. the skin is affected in red patched and has caused the psoriasis patient had to flair up dramatically throughout her body. there is swelling in patient's forearms and she sought the medical care of a physician who did not alleviate or even look at the affected areas and tried to prescribe patient a steroid which she refused (prednisone) as she had violent reactions to it as well. patient is on her way to see her Dermotologist tp seek relief and better medical care.
43 2021-05-17 swelling After couple of hours, the nerve on right cheek started paining. By morning, I was having pains all ... Read more
After couple of hours, the nerve on right cheek started paining. By morning, I was having pains all over the body and the nerves were swollen, looking bluish green. I took rest and Tylenol. After sometime, the pain went down. I took Tylenol for 4 days. My heart rate when resting was so high that I feared it could be wrong. On advice of a medical friend, took day off from work and rested. In two days, I got back to normal
43 2021-05-18 axillary mass Missed menstrual cycle - so far 2 Lump under left armpit
43 2021-05-18 lymph node swelling, lymph node pain Swollen and painful lymph nodes under left arm (visible, size of a tennis ball). Very heavy headache... Read more
Swollen and painful lymph nodes under left arm (visible, size of a tennis ball). Very heavy headache not subsided by Tylenol and Alieve. Pain in the left hip and knee. Extreme fatigue and dizziness.
43 2021-05-18 lymph node swelling On 5/18/21 I woke up at 0300 with severe pain in right arm. Took Ibuprofen and went back to bed. ... Read more
On 5/18/21 I woke up at 0300 with severe pain in right arm. Took Ibuprofen and went back to bed. Woke up around 0800 and had pain under my arm. Saw that my lymph node is severely swollen and sticking out of my arm pit. Its about the size of a baseball now on Day 3. It progressively got bigger throughout day 2
43 2021-05-18 peripheral swelling Red, swollen, sore/tender, itchy on injection site; Red, swollen, sore/tender, itchy on injection si... Read more
Red, swollen, sore/tender, itchy on injection site; Red, swollen, sore/tender, itchy on injection site; Red, swollen, sore/tender, itchy on injection site; Red, swollen, sore/tender, itchy on injection site; Swollen, sore spot in armpit; Swollen, sore spot in armpit; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EL1283), via an unspecified route of administration on left arm on 26Jan2021 08:00 as single dose for COVID-19 Immunization. Medical history included ongoing high blood pressure, ongoing prediabetes and allergic to sulfa. Concomitant medications included ethinylestradiol/norgestimate (TRI-SPRINTEC 28), losartan, metformin, vitamin D3 daily, ascorbic acid (VITAMIN C) daily and calcium, magnesium. The patient previously took lisinopril and experienced allergy. The patient historical vaccine included first dose of BNT162B2 (Lot number: EK5730) on 06Jan2021 (at 43-year-old) on right arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021, the patient experienced red, swollen, sore/tender, itchy on injection site and swollen, sore spot in armpit. The Patient did not receive any treatment for the events. The events were assessed as non-serious by the reporter. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was reported as recovering. Follow-up attempts completed. No further information expected.
43 2021-05-19 lymph node swelling swollen lymph nodes on right side of face; This is a spontaneous report from a contactable consumer ... Read more
swollen lymph nodes on right side of face; This is a spontaneous report from a contactable consumer (patient). A 43-Year-old female patient received BNT162B2 (COMIRNAT, Solution for injection, Lot number: EL3247 Expiration date: 31May2021), via unspecified route of administration in left arm on 16Jan2021 as 1ST DOSE, SINGLE for COVID-19 immunization. Medical History was not reported. The Patient Concomitant medications were not reported. The patient stated that she was having a reaction to her first dose that was given on 16Jan. She Stated that she tried to use Vsafe but was not getting a verification code, was Pfizer Covid vaccine. On 26Jan2021 the patient experience swollen lymph nodes on the right side of her face. The patient also stated that they would decrease and when she chews on something will increase, harden and make it painful. The patient stated that she has swollen lymph nodes on the right side of her face. Wanted to know what to do about the swollen lymph nodes. No treatment was given to the condition. The event of the outcome was not recovered. Follow-up attempts are completed. No further information is expected.
43 2021-05-19 swollen extremities, peripheral swelling, peripheral swelling, swollen extremities left swollen hand, exhaustion, edema of both legs, 3 pounds weight gain, eye floaters, confusion, ex... Read more
left swollen hand, exhaustion, edema of both legs, 3 pounds weight gain, eye floaters, confusion, exhaustion, widespread myalgiia and joint issues
43 2021-05-19 peripheral swelling Started with the right arm turning purple or changing colors when elevated above the head. This co... Read more
Started with the right arm turning purple or changing colors when elevated above the head. This continued for a few weeks. Then I started to get a tingling sensation in the elbow that went into the right pinky. I visited my primary doctor to see what was going on. She did an evaluation, prescribed Ibuprofen and physical therapy, and had a cervical spine x-ray done. The X-ray looked great when it came back. I could not get an appointment with PT for several weeks so I finally went to the chiropractor on 5/13. He worked on the shoulder area stretching it out. By the morning of 5/15 I was being taken to urgent care and eventually the ER because the arm was swelling and fingers were turning blue. They did blood tests, EKG, chest x-ray, and finally an ultrasound that showed a blood clot. It was DVT in the subclavian vein. I was given a blood thinner and sent home. I had a more thorough ultrasound on 5/17 that sent me back to the ER and with vascular surgeons to discuss immediate surgery with lysis therapy. It was decided that the blood clot had probably been there for weeks and the success rate of the surgery would not be as good.
43 2021-05-21 lymph node swelling Immediately - dizziness, heart racing, difficulty breathing, lightheadedness, pain in arm, slight tr... Read more
Immediately - dizziness, heart racing, difficulty breathing, lightheadedness, pain in arm, slight trembling, moderate chest pain. 20 minutes afterward - confusion, delusions, trembling, chills, uncontrolled teeth chattering, tensed muscles, uneven gait, arm pain slowed body mechanics. Persistent day of to 3 days after - low grade fever 101.3F, chills, excessive thirst, stiff joints, loss of range of mobility in finger movements, enduring arm pain, exhaustion, fatigue, muscle aches, photophobia, headaches, swollen glands, red mark on arm lasted for days. Longer range changes - persistent chills and fatigue. Menstrual cycle disrupted. Menstrual-like bleeding but 2 weeks early. Still bleeding.
43 2021-05-24 swelling 2nd dose: Around 6pm of the same day of the shot, I started feeling nauseous, throwing up, body ache... Read more
2nd dose: Around 6pm of the same day of the shot, I started feeling nauseous, throwing up, body aches, severe headache, fever. The next morning around 6am, I was bleeding out of my nose and butt, feeling worse than the night before. Monday evening, 5/10/21, I started having pain on the left side of my neck and chest pains and my left arm was going numb and was rushed to the ER. An EKG was done and I was checked by the Dr, which he said my neck was swollen and my arm was most likely numb from a pinch nerve. The EKG showed normal. Was sent home to rest and take Tylenol. I continued to feel sick the rest of the week. I noticed my lower part of my legs were then turning purple, which by the end of the following week has spread up to my thighs. It looks like honeycomb under my skin from my butt to my thighs dow n to my legs and my arms are faintly purple. The temperature does not make a difference.
43 2021-05-25 lymph node swelling Pfizer Vaccine Round 1 03/24/2021 8 days later severely swollen Lymph-nodes on left armpit with ma... Read more
Pfizer Vaccine Round 1 03/24/2021 8 days later severely swollen Lymph-nodes on left armpit with major back pain (Area where current lesion is at T5) PT care stated is was a new side effect from the vaccine. It took almost 3 weeks to get a little better. Pfizer Vaccine Round 2 04/14/2021 (LOT EW0162) Immediate relapsed in Lymph-node swelling and back pain again in same T5 area. 05/06/2021 Visited care facility as I felt numbness and tingling in stomach and all right leg from stomach to toes. Fully mobile and able to walk. Suggested I see a neurologist. 05/15/2021 Checked in to ER *Tingling, burning, pain, and light tingle in left side of face. *All test were done at this point. -MRI of brain and spine -Blood work -Spinal tap -Started IV Steroid infusions (total of 5 - last one given 05/19/2021) **** Diagnosed with MS (Multiple Sclerosis) ***** I never had any symptoms of MS prior to Covid-19 vaccine, never was diagnosed with any type of immune system disease. The timing of these symptoms and the Covid-19 vaccine are impeccably correlated knowing my own body.
43 2021-05-25 lymph node swelling Early period; swollen lymph nodes; Very tender breasts; This is a spontaneous report received from a... Read more
Early period; swollen lymph nodes; Very tender breasts; This is a spontaneous report received from a contactable consumer, the patient. A 43-years old Caucasian non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; batch/lot number: Unknown) via an unspecified route and site of administration for COVID-19 immunization on 08 March2021. Medical history included covid-19 and the patient was not allergic to the medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination and the patient was not tested for COVID-19 since the vaccination. The patient did not receive any Concomitant medication within 2 weeks of vaccination. On 14March2021 the patient experienced Very tender breasts, swollen lymph nodes and early period. No therapeutic measures were taken as a result of these events. The clinical outcome of very tender breasts, swollen lymph nodes and early period was unknown. No follow-up possible. Batch/lot number cannot be obtained.
43 2021-05-25 swollen extremities ON 01/19/2021, I HAD A SHARP PAIN IN MY LEFT CALF WHICH FELT LIKE A MUSCLE SPASM. FOLLOWING THIS I ... Read more
ON 01/19/2021, I HAD A SHARP PAIN IN MY LEFT CALF WHICH FELT LIKE A MUSCLE SPASM. FOLLOWING THIS I BEGAN HAVING EDEMA IN THE LEFT FOOT, ANKLE, AND LOWER LEG ASSOCIATED WITH PAIN. PAIN AND SWELLING WORSENED WITH PROLONGED STANDING DESPITE USE OF COMPRESSION SOCKS. VENOUS DOPPLER OF THE LEFT LOWER EXTREMITY OBTAINED AT MEDICAL CENTER ON 01/25/2021 SHOWED DVT. DR. ORDERED THE VENOUS DOPPLER AND THEN PRESCRIBED XARELTO FOR INITIAL TREATMENT. I FOLLOWED UP WITH MY PCP WHERE ADDITIONAL PRESCRIPTION FOR MAINTAINANCE XARELTO ANTICOAGULATION FOR A TOTAL OF 6 MONTHS WAS GIVEN.
43 2021-05-25 peripheral swelling labs are abnormal; blood pressure dropping; Then 8 days later i developed throbbing pain head to toe... Read more
labs are abnormal; blood pressure dropping; Then 8 days later i developed throbbing pain head to toe; low grade temp; sweats; swelling of joints, especially my fingers, hands and feet; swelling of joints, especially my fingers, hands and feet; diarrhea; dizziness; problems thinking; anxiety; About 4 hours after receiving my Covid vaccine I started to feel fatigue/severe fatigue; This is a spontaneous report from a contactable Nurse (Patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 08Apr2021 16:00 (Batch/Lot Number: EK8734) at the age of 43-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient was not pregnant. Medical history included Rheumatoid Arthritis, fibromyalgia, anxiety/depression, Known allergies: Sulfa, Covid-19 prior vaccination. Post the vaccination, the patient was not been tested for COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported; lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported. About 4 hours on 08Apr2021 after receiving her Covid vaccine she started to feel fatigue. Then 8 days later on 16Apr2021 08:00 AM, patient developed throbbing pain from head to toe, severe fatigue, low grade temp, sweats, swelling of joints, especially her fingers, hands and feet, diarrhea, blood pressure dropping, dizziness, problems thinking, and anxiety. His symptoms have progressively gotten worse and she had seen her family doctor, and her rheumatologist. Events resulted in: Doctor or other healthcare professional office/clinic visit. Leflunomide (ARAVA) and ibuprofen (MOTRIN) to help with inflammation and swelling. Her labs were abnormal, but chest X-ray normal on an unknown date. She have been off work since 26Apr2021. The outcome of the events was not recovered.
43 2021-05-25 swelling SOB; hives; axilla swelling; This is a spontaneous report from a non-contactable other health profes... Read more
SOB; hives; axilla swelling; This is a spontaneous report from a non-contactable other health professional. This other HCP reported for specific patient that a 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN0161) at the age of 43-years, via an unspecified route of administration on 17Apr2021 at single dose for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 03May2021, the patient experienced hives, axilla swelling and SOB. The events result in emergency room/department or urgent care. The patient received steroids as treatment to the events. Outcome of the events was recovering/resolving. No follow-up attempts are possible. No further information expected.
43 2021-05-26 white blood cell count increased Headache; Dizzy; had a hemorrhagic stroke in her left pontine/diagnosed with Pontine hemorrhage; whi... Read more
Headache; Dizzy; had a hemorrhagic stroke in her left pontine/diagnosed with Pontine hemorrhage; white blood cell count was a little elevated; her ear was ringing; This is a spontaneous report from a contactable consumer (patient's husband). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 43 years old on 24Apr2021 14:00 (lot number EW0171) given in her left arm at single dose for COVID-19 immunization. Medical history included slightly elevated blood pressure. Concomitant medication included amlodipine besilate (NORVASC) for slightly elevated blood pressure. Historical Vaccine included first dose of BNT162B2 (lot number ER8734) at the age of 43 years old given in her left arm on 03Apr2021 between 14:00-16:00 for COVID-19 immunization. Caller said his wife was in the hospital right now. He said she got the Pfizer COVID-19 vaccine on 24Apr2021 and then on 06May2021 she had a headache and was dizzy, then was admitted to the hospital and they found out she had a hemorrhagic stroke in her left pontine. Caller said that he was asked to report it due to proximity of this happening to getting the vaccine. Caller said his wife's headache and feeling dizzy started on 06May2021 at 2:30. He said that there was no treatment done for the headache. Patient described the headache she was experiencing feeling like she was a little dizzy, and said her ear was ringing, so he took her to go to bathroom and she said she didn't think she was able to stand anymore. He said he was holding her. He called the ambulance and they took her to the hospital where she was admitted 06May2021. This was within an hour or so, since she went by ambulance. Patient was diagnosed with pontine hemorrhage, which they could not treat, a pontine hemorrhage was not treatable, it had to stop bleeding on its own. He said for treatment they have let her rest, there was no surgical option for it, and no interventions that could be done. Caller said his wife's white blood cell count was a little elevated, but nothing came to his mind right now. The outcome of the events were unknown. Information on Lot/Batch number was available. Additional information has been requested.
43 2021-05-28 c-reactive protein increased, lymph node swelling Patient developed sharp substernal chest pain that was worse when lying down ~36h after her second d... Read more
Patient developed sharp substernal chest pain that was worse when lying down ~36h after her second dose of the Pfizer COVID vaccine in addition to typical side effects including subjective fever and malaise. Pain became constant on the second day post vaccination, and patient presented to the ED and was admitted to the Cardiac Progressive Care Unit. Laboratory data suggested acute pericarditis. PE was ruled out by CTA. The CTA also revealed normal appearing coronary arteries without calcification (a coronary event is unlikely). Her echo was normal, suggesting no significant myocardial involvement. No pericardial rub was heard. She was treated with high dose aspirin and became asymptomatic rapidly.
43 2021-05-28 lymph node swelling swelling/ pain in area of left armpit lymph node; Fatigue; General malaise; pain in arm where inject... Read more
swelling/ pain in area of left armpit lymph node; Fatigue; General malaise; pain in arm where injection occurred; Headache; Chills; aches; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route in the left deltoid, on 08Feb2021 15:15 (at the age of 43-year-old) at single dose for COVID-19 immunisation, administered at Workplace clinic. No relevant medical history were provided. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), administered via an unknown route in the left deltoid, on 20Jan2021 14:00 (at the age of 43-year-old) at single dose and developed swelling/pain in armpit of injection arm on 21Jan2021; flu shot last vaccination was annual flu shot in Sep/Oct2020 with no side effects. The patient did not have a relevant concomitant medications. No other vaccine was received in four weeks. On 08Feb2021 at 18:30, the patient developed pain in arm where injection occurred, headache, chills, aches, fatigue and general malaise. On 09Feb2021 at 18:00, the patient developed swelling/pain in area of left armpit lymph node. The events did not require physician office visit/emergency room visit. The patient was not hospitalized for the events. The patient had recovered from 'headache', 'chills', 'aches', 'fatigue', and 'general malaise' on 10Feb2021. The patient had recovered from 'pain in arm where injection occurred' on unknown date in 2021 while the patient had recovered from 'swelling/ pain in area of left armpit lymph node' on 15Feb2021. No Follow-up attempts are possible. No further Information expected.
43 2021-05-28 oral herpes developed a very small cold sore on my lip/developed Another cold sore; This is a spontaneous report... Read more
developed a very small cold sore on my lip/developed Another cold sore; This is a spontaneous report from a contactable 43-year-old female other health professional (patient). A 43-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an intramuscular route on 14Jan2021 at 16:30 (at the age of 43-years-old) as a single dose in the left arm for covid-19 immunisation. The patient's medical history included asthma and of HSV-1 (extremely rare-once every 2-3 years). The patient had allergies to eggs, different varieties of fish. The patient concomitant medications included levocetirizine dihydrochloride (XYZAL), Ibuprofen, Tramadol. On 21Jan2021 (6 days after vaccination), the patient developed a very small cold sore on her lip that did went away quickly and was completely healed within 3-4 days. After 4 days that she developed another cold sore, this time larger that she still currently had and patient due for the 2nd vaccine the next day. Patient concerned as this was not normal for her and wanted to know the vaccine lowered immunity where it would cause this kind of response and would the 2nd vaccine make this worse. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for the events. The events were assessed as non-serious. The patient was not recovered from the events. Follow-up attempts are completed. No further information is expected.
43 2021-05-31 swelling face Swollen lips, tongue, eyes, or face.
43 2021-06-02 peripheral swelling I began to have reddened areas as well as blanched (reynaud-like) areas on my hand as well as areas ... Read more
I began to have reddened areas as well as blanched (reynaud-like) areas on my hand as well as areas of what appeared to be micro vascular clots. I had swelling on one fingertip. Fingers were painful. I had something similar on my big toes
43 2021-06-03 oral herpes Oral herpes sore on lip (small) after 10 years of not getting one. Started the very night I got the ... Read more
Oral herpes sore on lip (small) after 10 years of not getting one. Started the very night I got the second dose.; Oral herpes sore on lip (small) after 10 years of not getting one. Started the very night I got the second dose.; This is a spontaneous report from a non-contactable consumer (reporting on herself). A 43-years-old Non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 29May2021 14:00, as 2nd dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 08May2021 14:30, as 1st dose, single for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Patient did not have any known allergies. On29May2021 17:00, patient experienced oral herpes sore on lip (small) after 10 years of not getting one. started the very night i got the second dose. Patient did not receive any treatment for adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
43 2021-06-04 peripheral swelling, lymph node swelling tired; pain in my left arm pit; I felt around its very swollen; It feels like swollen lymp node but ... Read more
tired; pain in my left arm pit; I felt around its very swollen; It feels like swollen lymp node but its large; having issues lifting my arm due to the pain; spiked a temp of 103.5; didnt feel well in the evening; This is a spontaneous report from a contactable Nurse (patient). 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 20May2021 12:30 (Batch/Lot Number: Ew0186) as 2ND DOSE, SINGLE for covid-19 immunisation. Patient received the first dose on 29Apr2021. Medical history included asthma and migraine. Concomitant medication included butalbital, caffeine, paracetamol (FIORICET) taken for an unspecified indication, start and stop date were not reported. After the first dose, I had a terrible migraine. I Took medication it didn't work. After the second dose, from 20May2021 21:00, I didn't feel well in the evening, was tired the following day. During the evening I spiked a temp of 103.5, took Tylenol. I feel a little better but still not well. I took a shower and had pain in my left arm pit. I felt around it's very swollen. It feels like swollen lymp node but it's large. I'm having issues lifting my arm due to the pain. Patient also felt tired on 20May2021. Outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.
43 2021-06-07 swelling face The first day, I had nausea and a huge headache. I think they shot me too high - pain when I moved m... Read more
The first day, I had nausea and a huge headache. I think they shot me too high - pain when I moved my arm for about a week - around rotator cuff. About a week later, I had stomach aches all week and diarrhea for a week - nothing changed in my diet so don't know what caused it. When the bump developed on the 23rd - mass developed on upper right forehead - goose egg developed. I had not bumped my head .I used some ice that night. When I woke up the next day, mass was much bigger - pushed on eye and eye brow. Pre-septal Cellulitis - diagnosis - entire forehead swelled up almost to the point that right up was completely closed up. Put on antibiotics. It didn't go down the first few days - I'm allergic to many antibiotics (had to switch it three times). They cut the infection out - there was a bunch of bacteria that got squeezed out. I had to have the infection cut out three times - because the swelling wouldn't really go down. I did a course of antibiotics for 10 days - Augmentin - 500 mg. I still have a slight bump there - probably scar tissue.
43 2021-06-08 axillary mass I woke up in severe pain in my left armpit; Swelling and pain in armpit of the arm of injection; I f... Read more
I woke up in severe pain in my left armpit; Swelling and pain in armpit of the arm of injection; I felt a large lump in that armpit; This is a spontaneous report from a contactable consumer or non-health care professional, the patient. A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route and administrated in the left arm on 12Mar2021 at 17:00 hours (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 14March2021, patient experienced severe pain in her left armpit after woke up, swelling and pain in armpit of the arm of injection, she felt large lump on that armpit it was for 5 days, and then pain was better but the swelling was not gone down. Patient did not receive any treatment for the reported events. On 14March2021, the patient was recovered from the events armpit pain, not recovered from the swelling armpit of the arm of injection, large lump. Information about lot/batch number cannot be obtained. No further information is expected.
43 2021-06-08 swelling face early menstuation within 48 hours and extremely heavy, extreme fatigue, extreme swelling around eyes... Read more
early menstuation within 48 hours and extremely heavy, extreme fatigue, extreme swelling around eyes, joints and face, pain in joints and back. symptoms subsided after 60 days
43 2021-06-09 peripheral swelling Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic for follow-up after second vaccinat... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic for follow-up after second vaccination reporting arm swelling. After first vaccination reported arm redness, swelling, and discomfort that resolved with home management. Fifteen days after initial vaccination patient reported fever, diarrhea, headache, and fever and tested positive for COVID-19. Patient's illness resolved with home management and received second vaccine. Arm swelling after second vaccine dose diagnosed as local reaction and home management advised.
43 2021-06-13 swelling Within 24 hours of the 2nd COVID-19 vaccine, I developed a rash around my abdomen and hips. This ini... Read more
Within 24 hours of the 2nd COVID-19 vaccine, I developed a rash around my abdomen and hips. This initially was treated with topically steriods and oral antihistamines, at normal doses. The rash became itchy and spread up my trunk and down my legs and presented as urticaria within 2 weeks of the 2nd vaccine. Within 4 weeks of the 2nd injection, I developed 2 episodes of facial angioedema of the eyes and lips, one of which necessitated an emergency room visit (3/9/21). I continue to be under the surveillance of an allergist and continue to wean antihistamine use and other acute allergic reaction medications. I continue to have transient facial swelling of my lips randomly that require additional antihistamine use to manage.
43 2021-06-13 neck mass, axillary mass Fatigue, unable to stay awake x 3 days , felt hot and cold, severe body pain, lump r side of neck th... Read more
Fatigue, unable to stay awake x 3 days , felt hot and cold, severe body pain, lump r side of neck then lump under arm pit , Bells Palsy
43 2021-06-15 swelling face Extreme swelling of left side of face (eye almost completely swollen shut), headache, fatigue, body ... Read more
Extreme swelling of left side of face (eye almost completely swollen shut), headache, fatigue, body aches, went to eye doctor and shingles was suspected. Prescribed antivirals and antibiotics.
43 2021-06-16 swelling I started having headaches that were pretty intense and constant. It progressed between doses to hav... Read more
I started having headaches that were pretty intense and constant. It progressed between doses to having a headache everyday. I had swelling and joint pain, I went to the doctor for the ongoing headaches except for some OTC treatment. I got some blurriness and numbness in my left shoulder. My biggest concern was the constant headaches. I also saw my rheumatologist. He increased my acthar between shots to see if it would calm things.
43 2021-06-19 lymph node swelling Joint pain - waking me up at night Swollen lymph nodes - groin, neck and under arms
43 2021-06-22 lymph node swelling Nausea; Body ache; Tiredness; Headache; Feeling unwell; Left arm swollen lymph nodes; This is a spon... Read more
Nausea; Body ache; Tiredness; Headache; Feeling unwell; Left arm swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via an unspecified route of administration in the left arm on 13Mar2021 at 11:45 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number: unknown) in the left arm on 20Feb2021 as single dose for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021 at 11:45, the patient experienced nausea, body ache, tiredness, headache, feeling unwell and swollen lymph nodes in left arm. The clinical outcome of the events nausea, body ache, tiredness, headache, feeling unwell and left arm swollen lymph nodes was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: added patient's information, updated first dose bnt162b2 as historical vaccine, updated concomitant therapy and amended narrative. No follow-up attempts are needed. No further information is expected.
43 2021-06-22 lymph node swelling 3-36 hours after shot: sore arm; 20-36 hours after shot: slight headache; 30-48 hours after shot: sw... Read more
3-36 hours after shot: sore arm; 20-36 hours after shot: slight headache; 30-48 hours after shot: swollen lymph nodes & nasal drainage
43 2021-06-22 lymph node swelling I woke up the next day nauseated, extreme, fatigue, body aches, feverish, I took Tylenol about 6:30P... Read more
I woke up the next day nauseated, extreme, fatigue, body aches, feverish, I took Tylenol about 6:30Pm fever broke body aches were gone. The following day I woke up tired and my lymph nodes were swollen and by Thursday the swelling went down.
43 2021-06-27 peripheral swelling I began to feel unwell 12 hours after receiving the 2nd dose of the vaccine. I started to notice sw... Read more
I began to feel unwell 12 hours after receiving the 2nd dose of the vaccine. I started to notice swelling in my extremities. My ankles, feet and legs and some on the top of my hands. I confirmed with others in my family that I wasn't imagining the swelling. I did reach out to my PCP and was seen on 3/25/21.
43 2021-06-29 peripheral swelling Major swelling under the arm; Major swelling under the arm and sideof breast. (Same side as vaccine ... Read more
Major swelling under the arm; Major swelling under the arm and sideof breast. (Same side as vaccine wasadministered); Very painful to touch ormove.; Very painful to touch or move. Also warm to the touch; Very painful to touch or move. Also warm to the touch and slightly red.; Major swelling under the arm and sideof breast. (Same side as vaccine wasadministered); This is a spontaneous report from a contactable consumer, the patient. A 43 years old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 19Mar2021 at 08:30 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. The patients medical history included anxiety, depression, and hypothyroidism. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and citalopram (MANUFACTURER UNKNOWN) for unknown indications from an unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration in the left arm on 24Feb2021 at 09:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 20Mar2021 at 09:00, the patient experienced major swelling under the arm and side of breast (same side as the vaccination was administered), which was very painful to touch or move. Also, warm to touch and slightly red. The clinical outcome of the events swelling in underarm, the side of breast, painful to touch or move and warm to touch and slightly red were not recovered. No follow-up attempts are possible; information about lot number cannot be obtained.
43 2021-06-29 swelling face First day 1 .Arm pain 2.Neck pain 3.headache Second day 4.chest Pain 5.Armpit pain 6.strong p... Read more
First day 1 .Arm pain 2.Neck pain 3.headache Second day 4.chest Pain 5.Armpit pain 6.strong pain in the arm 7. some difficulty to breath 8. Swelling face The rest of the days until today 6/30/2021 Armpit pain chest pain chest pressure some difficult to breath leg and feet pain
43 2021-06-29 swelling Swelling on the left collar area; This is a spontaneous report received from a contactable consumer,... Read more
Swelling on the left collar area; This is a spontaneous report received from a contactable consumer, the patient. A 43-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 16Mar2021 at 14:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via unspecified route of administration on 23Feb2021 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. Medical history and concomitant medication were not reported. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient reported no allergies to medications, food, or other products. On 17Mar2021, the patient experienced there was swelling on her left collar area was sensitive to touch. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the event. The clinical outcome of swelling was not recovered at the time of this report. Information about lot/batch number cannot be obtained. No further information expected.
43 2021-06-29 swelling tachycardia at night with patient unable to breathe, sore throat, laryngothoracic spasms at night an... Read more
tachycardia at night with patient unable to breathe, sore throat, laryngothoracic spasms at night and cough or inability to cough, incident of severe chest pain with dyspnea and jaw pain and slight swelling on the neck - resolved with beta-blockers, avula test positive
43 2021-07-01 high blood cell count pt tested covid positive 6/21/2021 pt admitted to hospital 7/1/2021 - fever, sore throat, difficulty... Read more
pt tested covid positive 6/21/2021 pt admitted to hospital 7/1/2021 - fever, sore throat, difficulty swallowing, leukocytosis, low potassium
43 2021-07-01 swelling Swelling on the left side of neck; Pain on the left side of neck; This is a spontaneous report from ... Read more
Swelling on the left side of neck; Pain on the left side of neck; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 16Mar2021 at 11:45 (at the age of 43-years-old) as a single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021 at 09:00, the patient experienced swelling and pain on the left side of neck about half an inch below the jaw bone and extending back below ear. The patient did not receive any treatment for reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling on the left side of neck and pain on the left side of neck were recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
43 2021-07-06 swelling face The day of I had sore arm, next day arm was more sore and started having toothache and sinus pressur... Read more
The day of I had sore arm, next day arm was more sore and started having toothache and sinus pressure. Saturday arm relieved, sinus was worse, swelling in my face, went to urgent care and got antibiotics and painkillers, Sunday I developed an abscess. Went to dentist today and they had to cut it open and drain it, will need root canal.
43 2021-07-08 peripheral swelling Left chest pain and pressure, extending into left arm, back and into jaw line. Shortness of breath,... Read more
Left chest pain and pressure, extending into left arm, back and into jaw line. Shortness of breath, non productive cough, nausea and vomiting. Symptoms worsen when laying flat or of up walking around. Swollen feet and legs. Still experiencing systems. Completed course of antibiotics, predniSONE 20 MG tablet, and toradol. Currently resuming Motrin 3x a day, albuterol sulfate 90 mcg inhaler, Pulmicort Flexhaler 180 mcg/actuation inhaler, ondansetron ODT 4 MG disintegrating tablet, benzonatate 100 MG capsule
43 2021-07-11 peripheral swelling May: tingly/pins-and-needles in hands June: loss of feeling/numbness in left lower leg; quickly foll... Read more
May: tingly/pins-and-needles in hands June: loss of feeling/numbness in left lower leg; quickly followed by acute weakness and loss of feeling/mobility in right leg and both hands and forearms
43 2021-07-11 peripheral swelling Patient report that after 20 mins of the vaccine she had a serve headache and nausea...next day felt... Read more
Patient report that after 20 mins of the vaccine she had a serve headache and nausea...next day felt pain all over her chest and arm and develop lumps under her breast and on her left arm... bad cramping, light headed and dizzy, heart was racing, chills and sweats
43 2021-07-12 lymph node pain, lymph node swelling So, I had flue like symptoms chills, body, sweats, join, paint, headaches, nausea and fatigue like c... Read more
So, I had flue like symptoms chills, body, sweats, join, paint, headaches, nausea and fatigue like crazy. Like feeling overall awful and that was the start as soon as I got it within the next 48 hours. The issue I've had since then that sent me to the UC was that I felt like I had a left ear infection. My left ear hurt which was on the same side that I had my shot on. Throbbing and painful and clogged left ear. I felt like I had an ear infection. A few days after that I found right behind my ear, I had a big swelling lymph node and that was before 07/01 and it is still there. I also have a large lymph node under my left armpit. They've swollen and they're painful and that's ultimately why I went in because I was feeling sick with a lot of fatigue and not feeling good. Because of the ear and lymph nodes behind the ear I wanted to make sure nothing was wrong. When I went to the UC I let them know that I didn't know if it was because of the vaccine. They tested and said I had some kind of infection and they put me on Augmentin it was a 10-day dose twice a day and that's what I began to become allergic to since I was prescribed that. I've had every side effect from Augmentin that you can have. I've had extreme diarrhea, bloating, stomach cramps, joint pains, nausea, lack of appetite and lack of sleep. As of yesterday, the doctor said, "oh yeah you're having reaction to that", and she switched me to Keflex 4 times a day for 10 days. Six days after my follow, my white blood cell count actually went up. Even though I was on antibiotics my infection increased instead of getting better.
43 2021-07-12 peripheral swelling Sharp pain in left hand/Feet swollen and in pain; Slurred speech eyes dilated; Body heavy and in pai... Read more
Sharp pain in left hand/Feet swollen and in pain; Slurred speech eyes dilated; Body heavy and in pain; Body heavy and in pain; Throat feels like it's closing up; I can feel my heart beating and like their are ants in my veins.; Felt like arms swollen/Feet swollen and in pain; My vision is now blurred and reduced significantly; My vision is now blurred and reduced significantly; Severe panic attacks; Slurred speech eyes dilated; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; 43-year and non pregnant at the time of vaccination), first dose via an unspecified route of administration, in arm left on 20Mar2021 11:00 (Batch/Lot Number: EN6204; Expiration Date: Jun2021) at unknown dose single for covid-19 immunisation. Medical history included Hashimoto's Thyroiditis; Metronidazole Allergy. Concomitant medication included levothyroxine at 25 ug. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination was Levothyroxine 25 ug. On 20Mar2021 11:30, patient had "I have chronic disease, Hashimoto's thyroiditis. Severe reaction, sharp pain in left hand, 20 mins later slurred speech eyes dilated, body heavy and in pain, throat feels like it's closing up. I can feel my heart beating and like theirare ants in my veins. Felt like arms swollen. Feet swollen and in pain. Took antihistamine Benadryl. Doctors at Urgent care said I'm not having anaphylaxis but having severe panic attacks. Given steroid injection. Swelling reduced, pain reduced. I was able to see again although my vision is now blurred and reduced significantly ". Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, covid test post vaccination: covid test type post vaccination=Other, covid test date=08Jun2021, covid test result=Negative. The outcome of the events was resolved with sequel.
43 2021-07-12 peripheral swelling feet are swollen; she can barely stand; My period is longer than usual / It gushes out like clots ti... Read more
feet are swollen; she can barely stand; My period is longer than usual / It gushes out like clots tissue of blood; stomach start hurting; My period is longer than usual / It gushes out like clots tissue of blood; This is a spontaneous report from a contactable nurse (Patient herself). A 43-year-old non-pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0180, Expiration date: Not reported) on 05Jun2021 via unspecified route of administration in the left arm as dose 1, single for COVID-19 Immunization. The patients medical history includes arthritis and pineapple allergy from and unknown date and unknown if ongoing. The patients concomitant medications were not reported. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient was not tested for COVID-19 prior to vaccination and not post vaccination. On 06Jun2021 the patient experienced under my stomach start hurting on 6Jun2021. A week after, my period came on 12Jun2021. My period is longer than usual. It is now 7 days and it is still going. It gushes out like clots tissue of blood and she can barely stand, feet are swollen on an unknown date. The reporter assessed the events as non-serious. On an unknown date the patient has done Sonogram result was unknown (not sure, thinks ok) and blood test on 26Jun2021 and was waiting on results. The patient stated she's experiencing after the first dose of the Pfizer BioNTech Covid 19 Vaccine. Reported about three symptoms, with the first symptom starting the day after on 06Jun2021, she started experiencing stomach pain, she described as persisting, it comes and goes, and this lasted an entire week, and still experiences this from time to time. The second adverse event is her feet are swollen and she can barely stand. And the third, and this is her primary concern is, on 12Jun2021, she had her menstrual period, and up until today, she is still having her period. Transfer agent clarifies from 12Jun2021-28Jun2021. Agent reports Reporter has already spoken with her doctor and was advised and is taking transaxemic acid, 650 mg, takes two of these every 8 hours, to relieve the excessive bleeding. States Reporter reports she has no prior history of heavy bleeding, just experienced this after the first dose. Transfer agent adds, Reporter may also report she did google some of the information, and it's not only her that experienced this adverse event. Transfer agent states he has already answered her medical information question. Reporter stated she does have time to go through questions when queried by agent, because right now her health was not good, because she keeps bleeding, keeps having her period, since she took the Pfizer thing. reporter provides her primary care doctor, but states they are not the one that gave her the transaxemic acid. Exact address unknown to Reporter and email address not provided. Reporter states she took the medication on 05Jun2021, then on 06Jun2021, her stomach started hurting, and was heavy, so the whole week on and off, it was hurting her and getting heavy, the whole week, Then on 12Jun2021, her period came and from 12Jun2021, until today 28Jun2021, she still has her period, and it's still going. Reporter confirms she reported all events on initial report, including stomach pain and swollen feet, when queried by agent. Reporter looks for report reference in her phone, and then vaccination card, and call was disconnected. Agent reached Reporter back on outbound call, and Reporter states she has the Pfizer thing I was asking her about, it was a screenshot. Reporter states when she was looking for the other information, she found the other information for agent. The patient reporter the treatment stated she started the tranexamic acid this past Saturday, she went to her GYN, but was seeing her primary doctor this week. Reporter stated she did tests with her GYN, and Saturday, she took a blood test before she went to take medication and is waiting on test result. Reporter states she thinks they did a sonogram or something, and not sure of results, but thinks it was ok. Reporter states she has to see her in ten days. Reporter has not been to emergency room, only to the doctor visit, but states if this continues, she may go to the emergency room to get a second or third opinion. Reporter confirms dose of transaxemic acid as provided by transfer agent of 650 mg, takes two, every eight hours. Reporter states, one more thing, when her period comes, it comes like clots, like when she goes to pee, it's a bunch of clots that she sees, a lot of clotting. Reporter is not sure, but states maybe she included it on initial report, it was on the eighteenth, and she thought this would have been done by now. Reporter asks, do you know how bad it is to get your period constantly?. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested
43 2021-07-15 lymph node swelling 20 minutes after vaccination my throat felt tight and my tongue felt large. Benadryl taken before va... Read more
20 minutes after vaccination my throat felt tight and my tongue felt large. Benadryl taken before vaccination helped that subside. 12 hours: menstrual spotting, pain at injection site, fatigue, nerve pain on both sides of my chest, lymph node swelling on the left side of my chest and my left breast. I was vaccinated in my right arm. 4 days: left elbow swelling 7 days: rash under my right arm near the vaccination site 21 days: left elbow still swollen I participated in V-safe and I was asked to submit this form.
43 2021-07-17 axillary mass large bumb under armpit; large bumb under armpit, tender to touch and moderate pain; This is a spont... Read more
large bumb under armpit; large bumb under armpit, tender to touch and moderate pain; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 20Mar2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 27Feb2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 21Mar2021 at 14:00, the patient experienced large bumb under armpit, which was tender to touch and had moderate pain 24 hours after receiving the second dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken for the event. The clinical outcome of the event large bumb under armpit which was tender to touch and moderate pain was resolving at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained" Amendment: This follow-up report is being submitted to amend previously reported information: 1. Age and unit 43 years added in Historical Vaccine 2. Row# 1 none removed in relevant history tab 3. Final sentence should be updated to "No follow-up attempts are needed; information about lot/batch number cannot be obtained"
43 2021-07-17 lymph node swelling, lymph node pain she began feeling dizzy; If she moved her head or eyes, she felt like she was spinning; She was leth... Read more
she began feeling dizzy; If she moved her head or eyes, she felt like she was spinning; She was lethargic for only 24-36 hours following the COVID-19 Vaccination; Her sweat glands, urine, bowel movements, & hair glands all smell differently. She said everything smells as if she ate garlic.; she felt completely wiped out; She had a bruise appear on her left arm at the COVID-19 Vaccine injection site almost a week later.; feel like she had COVID again; both her earlobes were swollen, red, and irritated; both her earlobes were swollen, red, and irritated; both her earlobes were swollen, red, and irritated; She felt like she gained weight since she received her first COVID-19 vaccination; She had a reaction to a pair of sterling sliver earrings that she had been wearing forever; The lymph nodes right behind both earlobes felt like they were swollen; the lymph nodes located behind both earlobes felt tender; achy; nauseous; This is a spontaneous report from a contactable consumer (patient reported for herself) from a 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EW0191, NDC number: 59267100001), via an unspecified route of administration, administered in arm left on 17Jun2021 14:34 (at the age of 43-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from on an unspecified date in Jan2021 to an unknown date (she had COVID in Jan). The patient's concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior vaccinations. The patient experienced achy, nauseous on an unspecified date in 2021; she had a reaction to a pair of sterling sliver earrings that she had been wearing forever; both her earlobes were swollen, red, and irritated; she felt like she gained weight since she received her first covid-19 vaccination; the lymph nodes right behind both earlobes felt like they were swollen; the lymph nodes located behind both earlobes felt tender; she had a bruise appear on her left arm at the covid-19 vaccine injection site almost a week later; feel like she had covid again on an unspecified date in Jun2021; she was lethargic for only 24-36 hours following the covid-19 vaccination; her sweat glands, urine, bowel movements, & hair glands all smell differently. she said everything smells as if she ate garlic; she felt completely wiped out on 18Jun2021; she began feeling dizzy on 19Jun2021 13:00, if she moved her head or eyes, she felt like she was spinning on 19Jun2021. Adverse events did not result in emergency room, physician office visit. Patient was experiencing side effects, she is scheduled for her 2nd dose of the Pfizer Covid-19 vaccine on 08Jul2021 she wants to know if it would it be okay if she went out an additional week, or would it compromise the efficacy. My reaction was a little more intense then thought. Patient who was reporting an adverse event from her first COVID-19 Vaccine shot on 17Jun2021 (Thursday). The patient said she was experiencing some odd side effects since she receiving the COVID-19 Vaccine. The patient said she had a reaction to a pair of sterling sliver earrings that she had been wearing forever. The patient said her sweat glands smell differently, and every fluid, or anything her body produced smelled differently. The patient said she was also dizzy and lethargic. Patient clarified on either Tuesday (22Jun2021) or Wednesday (23Jun2021), a week after patient had her first COVID-19 Vaccine, she was driving a 2 hour trip to her mother's house, and noticed her ears felt weird. She said when she arrived at her mother's house she looked in a mirror and saw both her earlobes were swollen, red, and irritated. She said the lymph nodes right behind both earlobes felt like they were swollen. Swollen, Red, & Irritated Earlobe Treatment: Patient stated she used rubbing alcohol that her mother had (she stated she did not have her mother's rubbing alcohol UPC Number, Lot Number and Expiry Date) on both earlobes. She said she again used the same rubbing alcohol on both earlobes before bedtime that evening. She said she continued to use rubbing alcohol on both earlobes the next morning, and evening. She said after she returned home, she used her own rubbing alcohol on both earlobes, providing: H-E-B generic brand 70% Rubbing Alcohol (UPC Number: 041220033737, Lot Number: 0519420, Expiry Date: Dec2023). Patient stated the (pierced) hole in both earlobes was better. She said the lymph nodes located behind both earlobes felt tender but were not swollen. She said her earlobes were no longer red and swollen. Patient clarified on Friday (18Jun2021), she noticed everything kind of smelled weird. She said it was not only her sweat glands, but her urine, bowel movements, and hair glands all smell differently. She said she thought she maybe ate some garlic, but she was zonked out on Friday (18Jun2021), so she knew she didn't. She said everything smelled as if she ate garlic. She said her sweat, bowel movements, and urine smell weird, like a sweet, garlicky smell, but she hadn't eaten any garlic. She said the smell had been persistent since she received the COVID-19 Vaccination. She said she asked her friends and family if they noticed the weird smell, and nobody else had noticed the weird smell, only her. Patient clarified she was lethargic for only 24-36 hours following the COVID-19 Vaccination. She said on Friday (18Jun2021) she felt completely wiped out. She said around 1:00PM on Saturday (19Jun2021) she began feeling dizzy. She said if she moved her head or eyes, she felt like she was spinning, and just very dizzy. She said she remained feeling that way through Tuesday (22Jun2021). Patient reported she felt like she gained weight since she received her first COVID-19 vaccination. She said may be her eating choices contributed to her weight gain, but her weight was normally stable. She said she ate healthy and ate fruits and vegetables. She said she was conscious of her water intake but had been eating out a bit more lately. Dizzy Treatment: Reported she drank over-the-counter electrolyte drinks, clarified as Gatorade Gatorlyte Rapid Rehydration Orange flavored drink. She said the Gatorade Gatorlyte had 5 times the electrolytes in it. She said she also drank coconut water. She said she drank a full bottle of Gatorade Gatorlyte Rapid Rehydration Orange flavored drink on Sunday (20Jun2021). She said on Monday (21Jun2021) and Tuesday (22Jun2021) she drank a half bottle of the Gatorade Gatorlyte Rapid Rehydration Orange flavored drink every morning (UPC Number: 052000047905, Lot Number: 1804YY022314, Expiry Date: Nov2021) and then had a serving of coconut water both afternoons (Full Circle Market Brand Coconut Water, UPC Number: 036800390843, Lot Number: L:035/21 02 10:292P01, Expiry Date: 04Feb2022). Lethargic Treatment: Reported on 18Jun2021 and 19Jun2021 she took 2-Ibuprofen 200mg soft gel capsules (400mg dose), (NDC Number: 0363161066, Lot Number: Z10038, Expiry Date: Jun2022). Patient reported she had a bruise appear on her left arm at the COVID-19 Vaccine injection site almost a week later. She said the bruise was now turning a green hue, and the bruise had improved. Patient reported she was concerned about the second COVID-19 Vaccine dose. She said she knew she needed both COVID-19 Vaccine doses, in order for the COVID-19 Vaccine to be effective. She asked if Pfizer would advise her waiting another week before getting her next dose on 08Jul2021. She asked if she went out another week past 08Jul2021, would the delay be helpful with the side effects she experienced after her first COVID-19 Vaccine dose, or would the delay impact the efficacy of the COVID-19 Vaccine. Patient stated she received her first dose of the Pfizer COVID-19 vaccine on 17Jun2021. and had a lot of side effects not listed that she could find and she is concerned about taking the second dose because of these reactions. Stated she had COVID in Jan and knew she was going to probably going to have some side effects, about 36 hours after the first dose she did feel like she had COVID again was just, achy and nauseous and very lethargic. Then after she recovered from those initial side effects she began getting very dizzy, where she couldn't move her head or her eyes normally, like trying to read phone or credits on the tv she was just spinning so the second day of that she couldn't do research herself on google so her sister started to look things up and thought she might need to try some Pedialyte or something, so she had some electrolytes, Gatorade rapid hydration and felt better within an hour but the next day felt the exact same way very, very dizzy it took three days of having to replenish with electrolytes before felt back to normal and then the day after had a sever reaction to sterling silver. Has worn these same earrings for years, never takes them out, but both had a sever reaction where it almost felt like her lymph nodes were swollen behind her ear, so she took them out and starting putting alcohol on 2-3 times a day and everything cleared up, on top of that the day after her vaccination she notices her sweat glands kinda smell different, after a week realizing that everything else still smells the same just her sweat glands smell differently. Response: A review of the Prescribing Information (LAB-1457-10.0 Revised: 25Jun2021) for Pfizer COVID-19 Vaccine did not find information regarding sweat glands smell differently or reaction to metals. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. The patient received treatment for the events. Outcome of the events her sweat glands, urine, bowel movements, & hair glands all smell differently. she said everything smells as if she ate garlic; she felt like she gained weight since she received her first covid-19 vaccination; the lymph nodes located behind both earlobes felt tender was not recovered; feel like she had covid again, achy, nauseous was unknown; she had a reaction to a pair of sterling sliver earrings that she had been wearing forever; both her earlobes were swollen, red, and irritated; the lymph nodes right behind both earlobes felt like they were swollen; she had a bruise appear on her left arm at the covid-19 vaccine injection site almost a week later was recovering; she was lethargic for only 24-36 hours following the covid-19 vaccination, she felt completely wiped out, both was recovered on 19Jun2021; she began feeling dizzy, if she moved her head or eyes, she felt like she was spinning, both was recovered on 22Jun2021.
43 2021-07-17 peripheral swelling left armpit swelling of gland.; This is a spontaneous report from a non-contactable consumer, the pa... Read more
left armpit swelling of gland.; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the arm left on an unknown date at 14:45 (at the age of 43-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunization. Medical history was not reported. The patient received unspecified medication within two weeks of vaccination. Patient was allergic to ibuprofen (MANUFACTURER UNKNOWN) from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021 the patient experienced left armpit swelling of gland. Event happened about 5 days after the first dose and the next morning after the 2nd dose. The first one went away after about 3 days. The patient did not receive any treatment for the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event left armpit swelling of gland was recovered. No follow-up attempts are needed. No further information is expected.
43 2021-07-17 swelling Neck stiff; Left armpit area swollen; Armpit area tender; Heart beat a couple of times felt veryrapi... Read more
Neck stiff; Left armpit area swollen; Armpit area tender; Heart beat a couple of times felt veryrapid; Neck sore; Itchy throat; Wheezing; Aches, hit by a truck feeling; Sweats; Sore left arm; Headache; Nausea; This is a spontaneous report from contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E86955 or EP6955) via an unspecified route of administration in the left arm on 28Mar2021 at 12:45 (at the age of 43-years-old) as a single dose, for COVID-19 immunisation. Medical history included asthma and body mass index (BMI). The patient did not have any allergies to medications, food, or other products. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) on occasion for an unknown indication from an unknown date. The patient did not receive any other vaccine within four weeks of vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in the left arm on 07Mar2021 at 15:30 (at the age of 43-years-old) as single dose, for COVID-19 immunisation. On 28Mar2021 at 17:30 (also reported as night of second dose), the patient experienced sore left arm, itchy throat, wheezing (needed to use inhaler), headache, sweats, nausea, aches, hit by a truck feeling which lasted until end of day on 29Mar2021. On 30Mar2021, the patient felt better but her neck was stiff and sore and left armpit area swollen and tender and heart beat a couple of times felt very rapid. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events of pain in arm, itchy throat, wheezing, headache, sweaty, nausea, pain, neck stiff, neck pain, local swelling, armpit pain and heart rate high was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
43 2021-07-19 swelling, lymph node swelling I woke at 2:30 AM the day after my shot (so 7/18/21) with chills, a fever of 101.3, and body aches i... Read more
I woke at 2:30 AM the day after my shot (so 7/18/21) with chills, a fever of 101.3, and body aches in my joints, teeth, and face. I was unable to sleep through it. Around 10AM, I took 400mg of ibuprofen and was able to sleep for a bit. I woke around noon feeling hot. I basically bounced from being too hot to being too cold all day, in and out of sleep, from here. At 8 PM, the left side of my upper chest started to hurt and I discovered a lump between my armpit and left breast. I determined this to be enlarged lymph nodes. It was very difficult to sleep that night due to this soreness (I can best describe that it felt like a bruised rib). The next morning, (so 7/19/21),
43 2021-07-21 lymph node swelling cervical and occipital lymph node enlargement; This is a spontaneous report from a contactable nurse... Read more
cervical and occipital lymph node enlargement; This is a spontaneous report from a contactable nurse. A 43-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on 22Mar2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included infiltrating duct carcinoma of breast. The patient had no known allergies to medications, food or other products. Concomitant medication included alprazolam (MANUFACTURER UNKNOWN) of 0.5mg, from an unknown date for unknown indication. It was unknown whether the patient had received any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021, 2 days after pfizer COVID vaccine, the patient experienced cervical and occipital lymph node enlargement. On 25Mar2021, the patient underwent lab tests and procedures, which included SARS coronavirus RNA, qual, PCR test (nasal swab) and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported event. The clinical outcomes of cervical and occipital lymph node enlargement were resolved on an unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
43 2021-07-22 lymph node swelling Swelling of lymph node above collar bone; This is a spontaneous report from a contactable consumer, ... Read more
Swelling of lymph node above collar bone; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included metformin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), probiotics (MANUFACTURER UNKNOWN), cyanocobalamin (B12); all for unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 02Apr2021, the patient experienced swelling of lymph node above collar bone. It was unknown if the patient had received treatment for reported event. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event swelling of lymph node above collar bone was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
43 2021-07-23 peripheral swelling significant arm swelling and pain in arm/arm pit
43 2021-07-25 peripheral swelling Started with itching all over, as the day progressed shoulder and arm swelled, lost feeling in hand,... Read more
Started with itching all over, as the day progressed shoulder and arm swelled, lost feeling in hand, shot area grew much larger, turned red, hot and very itchy. Extreme head aches, body aches, joint pain, nausea, light sensitivity.
43 2021-07-26 swelling face About an hour after I was given the shot the right side of my face swelled and went numb and tingly.... Read more
About an hour after I was given the shot the right side of my face swelled and went numb and tingly. My right arm became numb and tingly too. it lasted for about 4 hours. it subsided around 7pm that evening. The next day I had the same occurrence as the previous day but it lasted for about 6 hours, from around 11 am till 5pm or so.
43 2021-07-27 lymph node swelling fever; chills; muscle soreness; swollen glands; fatigue; headache; This is a spontaneous report from... Read more
fever; chills; muscle soreness; swollen glands; fatigue; headache; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any concomitant medications within two weeks prior to COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 03Mar2021 at 09:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 31Mar2021 at 20:30 the patient experienced fever, chills, muscle soreness, swollen glands, fatigue and headache. The patient wanted to report it because she experienced so many of the possible side effects. The adverse events had not resulted in a visit to the doctors or other healthcare professional office or clinic visit or emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events fever, chills, muscle soreness, swollen glands, fatigue and headache were recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
43 2021-07-28 lymph node swelling Extreme body aches muscles and joints; Extreme body aches muscles and joints; Headache; extreme swol... Read more
Extreme body aches muscles and joints; Extreme body aches muscles and joints; Headache; extreme swollen lymph nodes in axil area traveling to Brest and back; Nausea; vomiting; Dizziness; lethargy; Unable to move arm with injection site huge lump; Unable to move arm with injection site huge lump; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 at 14:15 (at the age of 43-years-old) as a DOSE 2, SINGLE for covid-19 immunisation. Patient medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took ace inhibitors and experienced drug hypersensitivity. No other vaccine was received in four weeks. The patient did not have covid prior vaccination and not tested for covid post vaccination. On 05Mar2021, the patient experienced extreme body aches muscles and joints, headache, extreme swollen lymph nodes in axil area traveling to breast and back, nausea, vomiting, dizziness, lethargy, unable to move arm with injection site huge lump. It was reported that, on 05Mar2021 at 04:00 PM the patient had extreme body aches muscles and joints. Headache extreme swollen lymph nodes in axil area traveling to breast and back. Nausea and vomiting. Dizziness and lethargy. Unable to move arm with injection site huge lump. No treatment was received for the events. Outcome of the events were recovered with sequelae in 2021(Recovered with lasting effects). No follow-up attempts are possible; information about lot/batch number cannot been obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021168274 same patient, different shot/event
43 2021-07-28 lymph node swelling In February I had swelling in my glands. A couple days I tried to get the swelling down. I decided t... Read more
In February I had swelling in my glands. A couple days I tried to get the swelling down. I decided to see one of my colleagues and they order lab work. My lab work as fine. It has since then gone down on its own. On June 22nd I developed severe pain in my abdominal and nausea and vomiting. I went to the ER, and I was diagnosed with a kidney stone. I had an appointment today with the urologist and I still have the kidney stone, and I am being treated for them.
44 2020-12-31 peripheral swelling After 12 hours of receiving the vaccination, my legs felt heavy. The bottom of my right foot felt ... Read more
After 12 hours of receiving the vaccination, my legs felt heavy. The bottom of my right foot felt numb after standing for a little time. The feeling of heaviness continued, but I was able to walk and completed my daily activities. My right arm felt painful similar to receiving a tetanus shot, I took some Tylenol and drank some coffee and felt better. However, the feeling of heaviness in my legs continued. On Sunday, my left leg continued to swell and I noticed that the area under my knee cap and above the upper part of the rim of my socks was visible swollen, red, and painful. I took some Motrin and the swelling improved. Later, I noticed I am having musculoskeletal pain and general body aches that improve with Mortin but returns. I am able to continue with my ADLs
44 2021-01-01 c-reactive protein increased Fever chills severe myalgia headache
44 2021-01-01 lymph node swelling, lymph node pain Woke up next day very fatigued, left work after 1/2 day and slept 20hrs Two days after injection ly... Read more
Woke up next day very fatigued, left work after 1/2 day and slept 20hrs Two days after injection lymph nodes very sore and swollen in armpit (pain with applying deodorant) Four days after injection bruising with about 3x3 cm area of redness/swelling present at injection site Daily headaches managed with ibuprofen Not anything too concerning but not comfortable. I have never reacted to a vaccine prior
44 2021-01-03 lymph node swelling Arm pain at injection site, fatigue, mild headache, swollen lymph nodes
44 2021-01-03 lymph node swelling Swollen L armpit, medial, at same side of vaccine. Resolved in 2 days with ibuprofen
44 2021-01-04 anaphylactic reaction, swelling face, peripheral swelling Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushin... Read more
Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 . Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more meds naproxen
44 2021-01-04 lymph node pain Day 1: (12/23/20) fatigue, mild headache Day 2: (12/24/20) fatigue mild headache Day 3-5 (12/25/20-1... Read more
Day 1: (12/23/20) fatigue, mild headache Day 2: (12/24/20) fatigue mild headache Day 3-5 (12/25/20-12/29/20)- large painful lymph node inflammation approx. size of a baseball. Right axilla.
44 2021-01-04 lymph node swelling, swelling L armpit swollen; L armpit lymph nodes swollen; Sensation of heaviness left arm; painful scapular ar... Read more
L armpit swollen; L armpit lymph nodes swollen; Sensation of heaviness left arm; painful scapular area; This is a spontaneous report from a contactable other health professional (patient). A 44-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/ Lot number: eh9899), intramuscularly on 22Dec2020 12:30 at single dose on left arm for COVID-19 immunization in hospital. Medical history included ongoing hypertension, allergic to shellfish. Concomitant medication within 2 weeks of vaccination included losartan, hydrochlorothiazide, vitamin C [ASCORBIC ACID], colecalciferol (VITAMIN D), zinc, paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced L armpit swollen/ L armpit lymph nodes swollen, sensation of heaviness left arm and painful scapular area from 23Dec2020 15:30. No treatment received for the adverse events. The outcome of events was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.
44 2021-01-04 lymph node swelling pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; te... Read more
pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; teeth hurting; cheeks were flushed and the neck; chin being red/redness on the chin; itching on the face; This is a spontaneous report from a contactable Other HCP (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration in left arm on 18Dec2020 at single dose for covid-19 immunisation. Medical history included lymphoma, hodgkin's disease, inflammation. Concomitant medication included prednisone. She had to finished 2 weeks worth of prednisone, it was for inflammation in her abdomen, she had finished the prednisone either on the 18Dec2020 the following day. The patient got her first dose of the covid vaccine on 18Dec2020. She was schedule for her 2nd dose of the covid vaccine on 08Jan2021. On 18Dec2020 after receiving the vaccine her cheeks were flushed and the neck, it first started with the chin being red, an hour later her cheeks and neck were flushed, but she felt this symptom was normal. She also added that on the day of the vaccine she had itching on the face, and redness on the chin, this was on 18Dec2020 about an hour after receiving the vaccine. The enlarged lymph nodes on her neck were noticed on 23Dec2020, as well as the severe sore throat, earache, and teeth hurting. Her pain with the turning of the head was more so noticed on 24Dec2020. It's painful to turn her head back and forth but she thought this was because of lymph nodes. She stated that she had a history of lymphoma and so swollen lymph nodes did worry her. The doctor gave her an antibiotic for it, and she was actually on a second round because she was not any better. The antibiotic was prescribed on 24Dec2020, and the second round started today 29Dec2020. The first antibiotic she was prescribed was Azithromycin also known as a Z-pak. The second antibiotic she was prescribed was amoxicillin clavulanate (AUGMENTIN). Her lymph nodes were getting better starting today 29Dec2020, today was the first date that she was feeling better overall. The patient underwent lab tests and procedures which included rapid covid test negative on 24Dec2020, strep throat swab negative on 24Dec2020. She has had no positive test for Covid prior the vaccine. She had been tested like 5 times now, all negative. She had no Covid antibody test prior to vaccine. She had no issues with vaccines in the past. The outcome of event cheeks were flushed and the neck was unknown. The outcome of events enlarged lymph nodes on her neck, severe sore throat, earache, teeth hurting was recovering. The outcome of events chin being red/redness on the chin, itching on the face was recovered on 18Dec2020. The outcome of event pain with the turning of the head was recovered on 28Dec2020.
44 2021-01-05 lymph node swelling lymphadenopthy; Injection site pain; joint pain; injection site swelling and redness (about the size... Read more
lymphadenopthy; Injection site pain; joint pain; injection site swelling and redness (about the size of a hard dollar); injection site swelling and redness (about the size of a hard dollar); This is a spontaneous report from a contactable other health professional (other HCP) reported for herself. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EK5730) via an unspecified route of administration at left arm on 30Dec2020 at 01:00 PM, at a single dose (dose number: 1) for COVID-19 immunization. Medical history included known allergies to apples, and no other medical history. The patient was not pregnant. Concomitant medications in two weeks included colecalciferol (VITAMIN D). No other vaccine received on same date. No other vaccine in four weeks. Facility where the most recent COVID-19 vaccine was administered was at hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced adverse events injection site pain, joint pain, lymphadenopthy, injection site swelling and redness (about the size of a hard dollar); all with start date on 30Dec2020 at 05:00 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was not recovered.
44 2021-01-06 lymph node swelling Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hur... Read more
Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hurt swollen lymph nodes tingling on the left side of her face
44 2021-01-07 lymph node swelling Fever to 101.4, rigors/ chills. Nausea and vomiting. Swollen axillary lymph nodes, body aches and he... Read more
Fever to 101.4, rigors/ chills. Nausea and vomiting. Swollen axillary lymph nodes, body aches and headache.
44 2021-01-07 swelling, peripheral swelling Swollen area under the skin on left hand that is causing numbness in the palm, thumb and first fing... Read more
Swollen area under the skin on left hand that is causing numbness in the palm, thumb and first finger. Some swelling to the hand as well
44 2021-01-08 axillary mass Headache, lump in right armpit, pain in right armpit unable to extend without sensation of pulling i... Read more
Headache, lump in right armpit, pain in right armpit unable to extend without sensation of pulling in armpit. Rash on upper chest itchiness of upper coast and left lower leg
44 2021-01-08 lymph node swelling Headache, chills, joint and muscle pain, fever of 102, nausea, lymphadenopathy Lt Axilla.
44 2021-01-08 swelling face I exp pain in my cheek and swelling of my face. On 12/27 I went to urgent care with a rash and di... Read more
I exp pain in my cheek and swelling of my face. On 12/27 I went to urgent care with a rash and diagnosed with Shingles. I had blisters with redness scalping which fell off on 1/8.
44 2021-01-08 swelling face 1st Dose Vaccine - I had localized itchy rash in my chest area 2nd Dose Vaccine - Right Cheek swelli... Read more
1st Dose Vaccine - I had localized itchy rash in my chest area 2nd Dose Vaccine - Right Cheek swelling, chills and dry mouth
44 2021-01-08 swelling Headache, Myalgia, NauseaVomiting, C/O light headness,felt hot,fatigue,chills,neck achy,injection si... Read more
Headache, Myalgia, NauseaVomiting, C/O light headness,felt hot,fatigue,chills,neck achy,injection site pain,swelling and warmth. Told to follow up with primary care doctor Narrative:
44 2021-01-09 lymph node swelling Large, lemon size swollen area in the axillary armpit. Area is marshmellowy feeling, not hard nor l... Read more
Large, lemon size swollen area in the axillary armpit. Area is marshmellowy feeling, not hard nor lumpy. Area aches and appears to be growing in size
44 2021-01-09 swelling face Face swelling 1st 6 hours. First night ( bilateral pinky fingers and right thumb) and every night th... Read more
Face swelling 1st 6 hours. First night ( bilateral pinky fingers and right thumb) and every night thereafter right thumb locked up during the night, then moves in trigger thumb motions when attempting to move. Goes away during day but reoccurs every night. Sudden onset the night of vaccination with no previous episodes. Dr appointment made 10 days later due to symptoms not getting better. Dr ordered bracing for wrist and thumb at night and 10 mg of meloxicam daily. Im on day 3 of tx. This was the first morning I woke with milder locking up and trigger thumb symptoms.
44 2021-01-09 swelling face I woke up the next morning 1/9/21 about 6am after receiving the vaccine the evening before, my face ... Read more
I woke up the next morning 1/9/21 about 6am after receiving the vaccine the evening before, my face and mainly my eye lids were extremely swollen. Later in the day, ~noon I spiked a fever of 102.4. I had overall body aches and chills.
44 2021-01-10 lymph node swelling, swelling Friday night - Sore arm and sore throat. Saturday morning - Woke up sweaty. Swollen lymph node on r... Read more
Friday night - Sore arm and sore throat. Saturday morning - Woke up sweaty. Swollen lymph node on right side of neck, close to collar bone. Very sore. As of today, Monday, 1/11, it is more swollen and hurts. And I'm still having night sweats plus am extremely hot but not having a fever.
44 2021-01-10 lymph node swelling 1/7/21 9pm- low grade Fever, chills, sore arm at injection site. 1/8/21 2pm-low grade fever, sore ar... Read more
1/7/21 9pm- low grade Fever, chills, sore arm at injection site. 1/8/21 2pm-low grade fever, sore arm at injection site, left axilla pain and swollen left axillary lymph nodes 1/9 to- present: swollen axillary lymph nodes and tenderness left axilla
44 2021-01-10 lymph node swelling Day of vaccination (Day 0) - felt mild chest tightness/difficulty breathing, relieved with 1 puff of... Read more
Day of vaccination (Day 0) - felt mild chest tightness/difficulty breathing, relieved with 1 puff of albuterol Day 1 - lymphadenopathy of left axilla lasted 2 days Day 2 - tachycardia HR 100, feeling faint, wanting to pass out for a couple of hours Day 4 - tachycardia HR 120 feeling faint, wanting to pass our for couple of hours
44 2021-01-10 lymph node swelling Redness, pain injection site, swollen armpit resolved
44 2021-01-10 lymph node swelling Sat. Jan. 9, 2021 Aches and swelling in left axilla, Sun. Jan 10, 2021 Woke up with left arm pain fr... Read more
Sat. Jan. 9, 2021 Aches and swelling in left axilla, Sun. Jan 10, 2021 Woke up with left arm pain from shoulder to forearm, pain got better with regular daily movement. Enlargement of the injection site welt, increase firmness, redness and diameter, deep centrally located bruise. Shoulder begins to ache consistently worsening with movement or pressure to area. Mon. Jan 11, 2021 More noticeable swelling to left axilla and swelling appears to left upper outer pectoral area and below clavicle. Arm feels heavy and like fluid is traveling down arm and into hands/fingers. Fingers, wrist and forearm have brief periods tingling and pain. Swelling feeling in left extremity feels better when hand is held up over head.
44 2021-01-10 lymph node swelling Light headedness, Foggy head, body ache, swelling in the axilla for 3 days after injection
44 2021-01-10 lymph node swelling Headache, Myalgia, Fever, left axillary lymph swollen Narrative:
44 2021-01-10 swelling Next Day - Wake up with fever, chills, headache, back pain, joints pain and a little nauseous. Those... Read more
Next Day - Wake up with fever, chills, headache, back pain, joints pain and a little nauseous. Those symptoms last for two days. Area of vaccination was red, hot and swelled for 4 days, with left axilar ganglion and both neck ganglion swelled for 4 days too.
44 2021-01-11 swelling face On January 6,2021 when I woke up my face was red, swollen and extremely warm. My face was like this ... Read more
On January 6,2021 when I woke up my face was red, swollen and extremely warm. My face was like this for at least 16 hours (very uncomfortable). Also, on January 6, 2021 at 1130pm I had horrible stomach pains, then started vomiting, after I was done vomiting I felt better. I did take 2 Benadryl and aleve to help When I got back injections and had surgeries I had the same reactions happen to me usually after 8-10 hours after I was out of surgery. I was given medicine to help with the discomfort either through IV or Benadryl.
44 2021-01-11 swelling face 24 hours after vaccine injection I experienced swelling, heat, tenderness and nodules to my chin and... Read more
24 hours after vaccine injection I experienced swelling, heat, tenderness and nodules to my chin and cheeks where I had dermal filler injections in March 2020. This did not resolve with Benadryl 50mg. On 1/10/21 I was given a Rx for prednisone and the tenderness and swelling resolved with 40 mg of Prednisone.
44 2021-01-12 lymph node swelling employee reported mild swelling and tenderness of right armpit area lymph nodes approximately 24 hou... Read more
employee reported mild swelling and tenderness of right armpit area lymph nodes approximately 24 hours post receiving second dose of covid 19 Pfizer vaccine on 1/7/2021 in right arm. When questioned the employee stated she also experienced the same mild swelling and tenderness of the armpit area lymph nodes with first dose of vaccine also. The first dose of vaccine was given 12/18/2020 at approximately 1600 in left arm and lymph node mild swelling and tenderness noted in left armpit the following evening. On both occasions the swelling and tenderness lasted 48-72 hours and occurred in the corresponding armpit of the arm which vaccine was administered
44 2021-01-12 swelling, anaphylactic reaction Moderate anaphylaxis reaction per urgent care provider. Developed severe hives and swelling, fever, ... Read more
Moderate anaphylaxis reaction per urgent care provider. Developed severe hives and swelling, fever, severe headache 2 days after vaccination. Was treated with Benadryl, Solumedrol IM, and Prednisone taper at local urgent care center.
44 2021-01-13 lymph node pain Left arm soreness 24 hours post injection (minimal) that improved within 48 hours. Supraclavicular ... Read more
Left arm soreness 24 hours post injection (minimal) that improved within 48 hours. Supraclavicular lymph node (left side- mildly tender), left sided neck pain, and left forearm tenderness that began almost 72 hours post vaccine. No fever. No other symptoms
44 2021-01-13 lymph node swelling constant pain in right underarm, swollen gland, sharp shooting pain in right underarm that goes towa... Read more
constant pain in right underarm, swollen gland, sharp shooting pain in right underarm that goes toward right breast and up to the right side on neck. pretty painful.
44 2021-01-13 lymph node swelling Lymphadenopathy of right axillary lymph nodes.
44 2021-01-13 lymph node swelling Chills; 100 temperature; Whole body soreness; Left arm severe pain; Left axilla lymph node swelling;... Read more
Chills; 100 temperature; Whole body soreness; Left arm severe pain; Left axilla lymph node swelling; Headache; the first dose administered on 19Dec2020 10:00 and the second dose administered on 05Jan2021; the first dose administered on 19Dec2020 10:00 and the second dose administered on 05Jan2021; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch EJ1685) via intramuscular on 19Dec2020 10:00 on left arm at a single dose and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch EL0142) via intramuscular on 05Jan2021 07:45 on left arm at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. Prior to vaccination, the patient did not diagnose with COVID 19. The patient was not allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive within 2 weeks of vaccination. The patient experienced chills, 100 temperature, Whole body soreness, left arm sever pain, left axilla lymph node swelling and headache on 05Jan2021 19:00. No treatment received for the adverse event. No covid tests post vaccination. The outcome of the events chills, 100 temperature, Whole body soreness, left arm sever pain, left axilla lymph node swelling and headache was recovering.
44 2021-01-13 swelling, lymph node swelling Swelling on left armpit and neck.
44 2021-01-14 lymph node swelling, lymph node pain Received injection in left deltoid around 3 pm. At about 9:00 am my left axillary lymph node was the... Read more
Received injection in left deltoid around 3 pm. At about 9:00 am my left axillary lymph node was the size of a quarter. It was very sore and painful to touch and movement. Pain scale 7/10. I treated it with warm compress infused with lavender oil, Ibuprofen 400 mg orally, self-massage, and rest. Symptoms lasted 24 hours. After 24 hours the lymph node was still swollen with dissipated soreness and pain. Pain scale 0-1/10.
44 2021-01-14 lymph node swelling I am a doctor. I think the nurse went a little subcutaneous in retrospect (she pinched up on my ski... Read more
I am a doctor. I think the nurse went a little subcutaneous in retrospect (she pinched up on my skin). I developed left supraclavicular lymphadenopathy on 12/25 and that is still present and unchanged. I reported that prior. I developed a rash similar to pityriasis rosea on 1/11. This is progressive and still present. I do currently also have fatigue and possible conjunctivitis.
44 2021-01-14 lymph node swelling Left supraclavicular lymphadenopathy started Dec 25th and still present, unchanged. Rash started o... Read more
Left supraclavicular lymphadenopathy started Dec 25th and still present, unchanged. Rash started on abdomen Jan 11th and progressive. worsening. Mildly itchy, spreading to back/arm/legs. Blanching. Fix eruption. Looks like pityriasis rosea
44 2021-01-14 lymph node swelling shot was in left upper arm- swollen lymph nodes under the arm being reported, last over 4 days
44 2021-01-14 swelling face Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the c... Read more
Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the chills and everything; lethargic feeling; weak; Nausea; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling/left leg went numb; whole left side of face swelled up; left eye turned red; pressure in head; felt like someone squeezing her eyeball out; eye went black/left eye looked bruised/blackness around the eyes; whole face went numb/left side of face slightly numb; bells palsy; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 05Jan2021 at single dose for COVID-19 immunization. Medical history included cutaneous t-cell lymphoma from 2017 and ongoing, ongoing cholesterol, ongoing thyroid, covid-19 from Nov2020 to an unknown date not ongoing (lasted about 1-1.5 months; she did not have any breathing problems) and blood cancer. Concomitant medication included bexarotene ongoing for cutaneous T-cell lymphoma, rosuvastatin ongoing for cholesterol, levothyroxine ongoing for thyriod. The patient underwent lab tests and procedures which included COVID 19: positive in Nov2020, found out tested positive around holiday. Clinical course: onset about 26 hours after administered the first dose; onset as soon as she got back to work next day: 06Jan2021. The side effects were at their worst for at least 24-48 hours. Further described as all side effects occurred only on left side of her body: whole left side of face swelled up on 06Jan2021; left eye turned red on 06Jan2021; whole face went numb/left side of face slightly numb on 05Jan2021; eye went black/left eye looked bruised on 05Jan2021; pressure in head on 06Jan2021; felt like someone squeezing her eyeball out on 06Jan2021, within the first 24-48 hours, her 'left leg went numb'. She called to talk to physician and nurse who advised her to take Benadryl; which she did take and the Benadryl stopped the side effects; but she could not take a lot of Benadryl or anything because she was at work. She stayed at work because at least there were healthcare professionals, adults in case she passed out; at home she has 7 young children and is also raising her grandchild. The side effects did not completely go away. The arm thing was normal; The next day she was at work and had the swelling on left side of face; blackness around the eyes; arriving home she had headaches on 07Jan2021 and then her leg went numb for like 20 mins; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling that she started panicking because she was driving on 06Jan2021. She calmed herself down thinking it's only the left side; you can drive with your right side to get home and be fine. It was more like left side of her body was asleep, tingling, she has never had that happen before. Everything else like the headache, flu feeling was about 48 hours later (on 07Jan2021). She had COVID already back in Nov2020 for about 1-1.5 months; the next side effects she had were like the COVID symptoms she had, like the chills and everything on 06Jan2021. She had the lethargic feeling again, her head was hurting, she felt extremely weak on 06Jan2021. Patient also felt nausea on 06Jan2021, Dizzy on 08Jan2021. Another doctor said it sounded like the side effects she experienced with the vaccine sounded like allergic reaction or Bell's palsy. Patient was asking the doctor if she could get like an Epi-pen or prescription Benadryl or something because she is afraid to get the second dose of Pfizer COVID-19 Vaccine and not have something to respond to side effects with. The outcome of event whole face went numb/left side of face slightly numb was recovered on 07Jan2021, for headaches was recovering, chills and nausea was recovered on 08Jan2021. Outcome of other events was unknown. Information about lot/batch number has been requested.
44 2021-01-15 lymph node swelling 2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a hea... Read more
2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a headache and felt tired so took some melatonin, had a hot toddy, and went to bed early. Woke up roughly 18 hours post vaccine with back aches and lower rib pain when I took a breath. Took my temp, it was 100*. By 21 hours I had a temp of 102*. My groin, neck, and left arm pit lymph nodes were enlarged as well. After sleeping most of the day away, it felt like my fever 'broke' at 28 hours, it came down to 101*. Finally I took some Tylenol at 34 hours so I could sleep from the back pain. Woke up the next morning at 45 hours with a stiff back/neck but temp down to 99*. I also had a swollen and reddened entire deltoid where the shot had been given (painless when shot given and no blood after), almost like a cellulitis or allergic reaction. My left armpit lymph node remains enlarged but not as painful. Now almost 72 hours out, the only residual effects are a decreasing but enlarged left armpit lymph node, improving swollen/reddened deltoid, decreased appetite, and decreased energy level.
44 2021-01-17 lymph node inflammation 7 DAYS OF SINSTOMES,PAIN ON IJECTION SITE,SWELLING ON INJECTION SITE PAIN AND SWELLING ON RIGHT ARM ... Read more
7 DAYS OF SINSTOMES,PAIN ON IJECTION SITE,SWELLING ON INJECTION SITE PAIN AND SWELLING ON RIGHT ARM PIT (GANGLIOS INFAMATION )
44 2021-01-17 lymph node swelling Axilla on right side is swollen with enlarged lymph nodes, redness, warm to touch, and painful.
44 2021-01-18 lymph node swelling Chills; Fever; Severe body aches; Lymphadenopathy; Exhaustion; This is a spontaneous report from a c... Read more
Chills; Fever; Severe body aches; Lymphadenopathy; Exhaustion; This is a spontaneous report from a contactable physician (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), via intramuscular route of administration on 06Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history included patient was diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other product. Concomitant medications included escitalopram oxalate (LEXAPRO), alprazolam, and estazolam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 15:00, the patient experienced chills, fever, severe body aches, lymphadenopathy, and exhaustion. Treatment for the events included ibuprofen, Tylenol, sleep, and hot bath. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.
44 2021-01-18 lymph node swelling moderate supraclavicular lymph node sweeping and lymphadenopathy behind left ear and armpit on left ... Read more
moderate supraclavicular lymph node sweeping and lymphadenopathy behind left ear and armpit on left side; This is spontaneous report from a contactable nurse (patient herself). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular (left arm), on 06Jan2021 at 15:45, at a single dose, for COVID-19 immunization. The patient has no relevant medical history, no known allergies, and was not taking concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ek5730) intramuscular in the right arm on 16Dec2020 at 18:00, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. On 05Jan2021, at 16:30, the patient experienced moderate supraclavicular lymph node sweeping and lymphadenopathy behind left ear and armpit on left side. It was unknown if the patient received treatment for the events. Outcome of the events was not recovered.
44 2021-01-19 anaphylactic reaction Systemic: Anaphylaxis, Systemic: Seizure-Severe
44 2021-01-20 swelling Day 7 post vaccine developed hives and angioedema on face chin and forehead
44 2021-01-21 lymph node swelling, peripheral swelling I woke up earlier that usual , I had a terrible headache and by lateral tenatis. I felt dizzy and my... Read more
I woke up earlier that usual , I had a terrible headache and by lateral tenatis. I felt dizzy and my left arm all the way to the finger was swollen. I had pain in the wrist arm, joints and fingers. I determined it was due to the swelling. I had some lymph node enlargement, and was really fatigue and slept most of the day. (36 hours). I did not have a fever. I'm a doctor and did some evaluations on myself. I didn't have trouble breathing of swallowing. If I wasn't medically trained I would have gone into the doctor. I did see an ENT for hearing test to make sure there was no damage and there was not.
44 2021-01-21 lymph node swelling Extreme swollen lymph node to lt axilla, approximately size of a baseball. Chills and significant fa... Read more
Extreme swollen lymph node to lt axilla, approximately size of a baseball. Chills and significant fatigue.
44 2021-01-21 swelling face COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchines... Read more
COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchiness all over, dizziness and weakness.
44 2021-01-24 lymph node swelling Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short dur... Read more
Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short duration), slight lymph node enlargement in neck, tiredness, aches and discomfort, "flu-like" lasted approx. 30 hours
44 2021-01-24 peripheral swelling, swelling face itching of all over body, started on arms and head the day following the vaccination. The second day... Read more
itching of all over body, started on arms and head the day following the vaccination. The second day following the vaccination I woke up with a swollen face and later on in the day my hands started swelling a lot. On the third day in my feet swell very little compared to my hands. I took benadryl which seemed to help. I have an appointment with my pcp tomorrow to get checked out. Today is day 5 and my hands are still swollen but the severity has lessened over the day today. I am very itchy all over my body.
44 2021-01-25 lymph node pain, lymph node swelling mild swelling and tenderness of corresponding vaccine site arm in armpit lymph nodes; mild swelling ... Read more
mild swelling and tenderness of corresponding vaccine site arm in armpit lymph nodes; mild swelling and tenderness of corresponding vaccine site arm in armpit lymph nodes; This is a spontaneous report from a contactable pharmacist. A 44-year-old female patient received bnt162b2 (BNT162B2), the first dose (lot number: EH9899, expiry date: not reported), intramuscularly, on 18Dec2020 04:00 PM, at a single dose, on the left arm; and the second dose (lot number: EL1284, expiry date: not reported), intramuscularly, on 07Jan2021 11: 00 AM, at a single dose, on the right arm, both for COVID-19 immunization. The vaccine was administered in a hospital. The patient was not pregnant. Medical history included COVID. It was reported that patient was diagnosed with COVID prior to vaccination and was not tested for COVID post vaccination. The patient had no known allergies. Concomitant medications included ethinylestradiol, levonorgestrel (JOLESSA), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), ergocalciferol (VIT D); these are the other medications she received in two weeks. The patient did not receive any other vaccine within four weeks. The patient experienced mild swelling and tenderness of corresponding vaccine site arm in armpit lymph nodes the evening following both covid 19 vaccine doses 1 and 2. This lasted 48-72 hours and then resolved. The first dose was received on 18Dec2020 with reaction occurred on 19Dec2020. The second dose was received on 07Jan2021 with reaction occurred on 08Jan2021 06:00 PM (also reported as "09Jan2021"). The patient did not receive any treatment for the reported adverse events. Outcome of the events was recovered on an unspecified date.
44 2021-01-26 lymph node swelling arthralgia; fatigue; insomnia; soreness at site of injection; swollen lymph nodes on left anterior c... Read more
arthralgia; fatigue; insomnia; soreness at site of injection; swollen lymph nodes on left anterior clavicular region; Fever (99.9 at highest); chills; first dose was received on 27Dec2020/2nd dose on 13Jan2021; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302 and expiry date:May2021), via an unspecified route of administration on the left arm on 13Jan2021 13:30 at single dose for covid-19 immunisation. The first dose was received on 27Dec2020 13:30 on the left arm, Medical history included hypertension, anxiety, GERD (gastrooesophageal reflux disease) and insomnia. Concomitant medication included atenolol, omeprazole (PRILOSEC), hydroxyzine hydrochloride (VISTARIL) and unspecified multivitamins. The patient previously took neomycine and experienced drug hypersensitivity. The patient experienced fever (99.9 at highest), chills, arthralgia, fatigue, insomnia, soreness at site of injection, swollen lymph nodes on left anterior clavicular region on 14Jan2021 05:45. No treatment was given for the events. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The reporter considered the events non-serious.
44 2021-01-26 swelling Diarrhea, nauseated, headache, fever, arm pain, body aches, chills, joint pain, skin burning, facial... Read more
Diarrhea, nauseated, headache, fever, arm pain, body aches, chills, joint pain, skin burning, facial redness, left chest wall swelling and tenderness. Seen Dr today
44 2021-01-27 swollen extremities, swelling face Edema in both hands and arms. Swollen face Lower lip swelling and tongue swelling
44 2021-01-27 swelling face I had flu-like symptoms after the 2nd dose for 4 days. I got radiesse filler in my face 1/22/21 a... Read more
I had flu-like symptoms after the 2nd dose for 4 days. I got radiesse filler in my face 1/22/21 and about two days later developed facial swelling out of proportion to expected swelling
44 2021-01-27 swelling face 1/15/21 had itching on the scalp 1/16/21 @8pmdeveloped hives around the neck with the upper lip swel... Read more
1/15/21 had itching on the scalp 1/16/21 @8pmdeveloped hives around the neck with the upper lip swelling. Took Tab.Benadryl and Tab.Pepcid .Tab Benadryl continued 3 times. 1/17/21 @9.30pm developed more hives on thighs and lower lip swelling. Centracare was closed. continued Tab.Benadryl and Pepcid. The following day while woke up in morning@8.30am, noted all my face swollen with hives all over the body more on the trunk. seen by PCP. Inj.Solumedrol 125mg IM given, and a Medrol pack given. symptoms started to subside by the following day and took almost 4 days for the complete recovery. Took a call off from work.
44 2021-01-28 swollen extremities Had first vaccination on 1/6/21. After second injection, severe pain under her right arm with swell... Read more
Had first vaccination on 1/6/21. After second injection, severe pain under her right arm with swelling that has not subsided after 24 hours.
44 2021-01-28 swelling face My face was bright red and very hot and swollen cheeks I felt nauseous Very bad headache Very thi... Read more
My face was bright red and very hot and swollen cheeks I felt nauseous Very bad headache Very thirsty
44 2021-01-28 swelling face No initial reaction. About 9 hours later she woke up from sleep with wheezing and itching of the thr... Read more
No initial reaction. About 9 hours later she woke up from sleep with wheezing and itching of the throat, ears, and armpits. She developed three hives on her abdomen. She took diphenhydramine and Claritin then was able to go back to bed. She did not use the EpiPen but had it available. When she woke up in the morning she had swelling of the eyelids and face.
44 2021-01-30 swelling Fever, painful swelling redness and bruising since 5 hours after administering vaccine.
44 2021-01-31 lymph node swelling Approximately three hours after injection the lymph node in the armpit closest became swollen and ar... Read more
Approximately three hours after injection the lymph node in the armpit closest became swollen and arm was sore. Administered Tylenol. At approximately midnight woke up with severe chills, fever (103) , Body pain, Severe eye pain and nausea. Developed a headache and sweating throughout the night. Continued to administer Tylenol at regular intervals. Sweating was profuse in that pajamas needed to be changed twice. At this point it has been more than 24 hours and though the symptoms have reduced in severity, eyes are still very sore and still experiencing chills and low-grade fever off and on. I would?ve gone into urgent care but there was a huge snowstorm. The reaction was quite concerning and very surprising. There was literally only a sore arm and mildly at that from the first injection .
44 2021-01-31 oral herpes She noticed a cold sore that occurred the day after she received the 2nd dose of vaccine. Treated wi... Read more
She noticed a cold sore that occurred the day after she received the 2nd dose of vaccine. Treated with Valtrex
44 2021-02-02 swollen extremities I had my 2nd dose of the Pizer vaccine on 1/30/2021 (Saturday at 4:20pm). The shot was given in my ... Read more
I had my 2nd dose of the Pizer vaccine on 1/30/2021 (Saturday at 4:20pm). The shot was given in my left arm. On 2/1/2021 Monday 10:00am) my left armpit was swollen and sore. You could visibly see the swelling. It was about the size of a lemon. I contacted my doctor who said the reaction was normal, but I wanted to report it because it was an adverse reaction. The swelling went down but is not gone, as of today, Wednesday 2/3/2021. I sent my doctor pictures as he is not seeing clients in person.
44 2021-02-03 lymph node swelling RECEIVED VACCINE ON WEDNESDAY JAN,20. JANUARY 21,2021 I HAD MUSCLE ACHES AND TEMPERATURE OF 101. SY... Read more
RECEIVED VACCINE ON WEDNESDAY JAN,20. JANUARY 21,2021 I HAD MUSCLE ACHES AND TEMPERATURE OF 101. SYMPTONS GOT WORSE NEXT DAY WITH INCREASED BODY ACHES,FEVER,SNEEZING, EAR PAIN,GLANDS SWOLLEN. TESTED FOR COVID 19 ON 01/26/2021. RESULTS WERE NEGATIVE AND WAS TOLD TO FOLLOW UP WITH PCP AND COULD NOT RETURN TO WORK TILL SYMPTONS IMPROVING. WENT TO PRIMARY DOCTOR AND WAS SWABBED FOR FLU,BACTERIAL.FUNGAL INFECTION. RESULTS CAME BACK AS BACTERIAL INFECTION AND AM NOW ON BACTRIM DS. STILL HAVING HEADACHE AND TIREDNESS.
44 2021-02-03 lymph node swelling enlargement of lymph nodes under left axilla; no treatment to date, lumps are still there after 3 we... Read more
enlargement of lymph nodes under left axilla; no treatment to date, lumps are still there after 3 weeks
44 2021-02-04 oral herpes 1/30 08:00 Severe chills, weakness, fever. Slept for approx. 10 hrs. Symptoms began to ease in the e... Read more
1/30 08:00 Severe chills, weakness, fever. Slept for approx. 10 hrs. Symptoms began to ease in the evening with full recovery to baseline 1/31. 2/1 05:00 Upon waking, I noticed I could feel cold sores beginning on my lips. I occasionally experience A SINGLE cold sore after extreme exposure to elements, but not usually after illness. This morning I could feel MANY cold sore forming on my lips (top and bottom) as well as insides of my cheeks and gums. I can count at least 15 different sores that all came on simultaneously. Treating sores as usual with frankincense and balm to reduce cracking and bleeding. Sores taking usual clinical course, not healed yet.
44 2021-02-04 peripheral swelling was always in the bed not wanting to do anything; Weakness; tired; Chills; sore arm; Swollen arm; Jo... Read more
was always in the bed not wanting to do anything; Weakness; tired; Chills; sore arm; Swollen arm; Joint pain; Muscle pain; she was severely sick for 11 days; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 31Dec2020 0930 at a single dose on the right arm for COVID-19 immunization. Medical history included ongoing cholesterol problems from 2019 (manages without medication) and colitis. Concomitant medications were not reported. The patient previously took doxycycline from Aug2020 to 30Dec2020 for colitis. The patient experienced muscle pain, joint pain, sore arm and swollen arm on 31Dec2020. She experienced weakness, tired, chills on 01Jan2021, and was always in the bed not wanting to do anything on an unspecified date. The patient stated she was severely sick for 11 days and stated her covid and flu test came back negative. She said she could not work and was off work due to the side effects. She had to go to urgent care also. She wanted to know about taking the second dose. She was scheduled to get her second dose on 22Jan2021. She was sick with the first dose. She was weak, tired, had chills and was always in bed not wanting to do anything. She asked if these events will come back with the second dose and if it is possible to not get the second dose. She also reported that her arm was sore. She had joint and muscle pain. She tried to fight it. The weakness and chills continued off and on. She returned to work on 12Jan2021. She went to the urgent care and has also went to see her physician. She had lab work done. She also had a rapid Covid and flu test, both of which were negative. Outcome of weakness and chills was recovering; outcome of sore arm and swollen arm was recovered on 04Jan2021; outcome of joint pain and muscle pain was recovered on 12Jan2021; outcome of tired was not recovered; outcome of "she was severely sick for 11 days" was recovered on an unspecified date; outcome of "always in bed not wanting to do anything" was unknown. Information about batch/lot number has been requested.
44 2021-02-06 lymph node swelling Swollen lymph nodes
44 2021-02-06 peripheral swelling Arm swollen, red and hot and very itchy. Developed rash all the way down to elbow.
44 2021-02-06 peripheral swelling 1408 Numbness and tingling of bilateral cheeks and swelling of fingers. Denies SOB, dysphagia,cough,... Read more
1408 Numbness and tingling of bilateral cheeks and swelling of fingers. Denies SOB, dysphagia,cough,diziness,syncope,Vital 120/82,82,96%. Given Benadryl 50mg po. 1419 Reports symptoms calming down less sensation of swelling and calming down. 1433 spoke with husband and notified of situation. 1515 Patient exited in stable condition. Agreed and understands of what to do if symptoms worsen or continue.
44 2021-02-07 lymph node pain Friday 7:30 nausea- took zofran sublingual. 7:30-3pm headache , runny rose, body ache, shakiness, w... Read more
Friday 7:30 nausea- took zofran sublingual. 7:30-3pm headache , runny rose, body ache, shakiness, watery eyes. 3-6pm felt recovering. Friday 9pm-Sunday 4pm abd pain got added to the mix with bloating and abd distension. Friday?s symptoms lessen. Took meds and alkaline products to balanced things out. Ate bread crackers constantly to help with acid buildup and damage of mucosal lining. Protonix 40mdg only alleviate pain for 30 minutes. Could not sleep for over 24 hrs. Pale white stool. Axillary lymph nodes pain. Monday and pain better. Felt lethargy and numbness to hand and feet. Mild Headache still persist.
44 2021-02-07 peripheral swelling Itching and swelling in hands and feet.
44 2021-02-07 peripheral swelling Itching and swelling on hands and feet.
44 2021-02-07 swelling pain and swelling in arm pit of left arm; pain and swelling in arm pit of left arm; This is a sponta... Read more
pain and swelling in arm pit of left arm; pain and swelling in arm pit of left arm; This is a spontaneous report from a contactable Non-healthcare Professional. This Non-healthcare Professional reported that a 44-years-old female patient received bnt162b2 (BNT162B2; brand=Pfizer COVID; lot number=EL3302) second dose, via an unspecified route of administration at Left arm on 20Jan2021 11:30 AM at SINGLE DOSE for covid-19 immunisation. Medical history included lymphocytic colitis from an unknown date and unknown if ongoing, diagnosed with covid-19 prior to vaccination. No Allergies to medications, food, or other products. Historical vaccine included received first dose of Pfizer COVID 19 vaccine (lot number=EL3246) on 30Dec2020 at left arm for covid-19 immunization. Concomitant medication included budesonide and OTC vitamins. The patient experienced pain and swelling in arm pit of left arm on 22Jan2021 08:00 AM with outcome of recovering. No treatment received. The events reported as non-serious.The patient was not pregnant and not Pregnant at the time of vaccination.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient not been tested for COVID-19.
44 2021-02-08 anaphylactic reaction, swelling face Provider stated patient had anaphylaxis (facial swelling) at around 2:16, 1 dose epi pen was adminis... Read more
Provider stated patient had anaphylaxis (facial swelling) at around 2:16, 1 dose epi pen was administered and rapid response called. Patient was transported to the ed . Per providers note, developed sensation of Facial swelling, lip swelling, tongue swelling and difficulty breathing
44 2021-02-08 axillary mass Events lasting approximately 48 hours (onset 18 hours after vaccine): Allodynia (whole body) Muscle... Read more
Events lasting approximately 48 hours (onset 18 hours after vaccine): Allodynia (whole body) Muscle aches (whole body) Debilitating headache Pain and swelling at injection site (right arm) Painful joints *Safe dose range of OTC Tylenol ineffective Ongoing effects (onset approximately 24 hours after first vaccine): Painful lump right breast/armpit
44 2021-02-08 lymph node pain, lymph node swelling Side effects of headache, bone pain, extreme fatigue, and lymph nodes in R axilla are swollen and so... Read more
Side effects of headache, bone pain, extreme fatigue, and lymph nodes in R axilla are swollen and sore. Treatment taking advil or Tylenol and rest. Received the vaccine on Friday 2/5/21 side effects lasted until Sunday 2/7/21 except lymphnode swelling and pain still present on 2/9/21
44 2021-02-08 lymph node swelling Pfizer-BioNTech Covid-19 Vaccine EUA 2/7/2021 @3am- fever which subsided at 11:30am, chills, body ac... Read more
Pfizer-BioNTech Covid-19 Vaccine EUA 2/7/2021 @3am- fever which subsided at 11:30am, chills, body aches, headache, fatigue lasting all day 2/8/2021- swollen lymph node left axilla, soft tissue swelling left axilla, no redness
44 2021-02-08 peripheral swelling cellulitis from Right shoulder to Right elbow within 48 hours of shot, necessitating antibiotic ther... Read more
cellulitis from Right shoulder to Right elbow within 48 hours of shot, necessitating antibiotic therapy for cellulitis.; Fevers to 102 F; chills x 48 hours; severe Right arm swelling; This is a spontaneous report from a contactable physician (patient). A 44-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number 4121 EL 1283) , via an unspecified route of administration from 19Jan2021 13:15 at single dose on right arm for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced cellulitis from right shoulder to right elbow within 48 hours of shot, necessitating antibiotic therapy for cellulitis. The patient experienced fevers to 102 f, chills x 48 hours, severe right arm swelling on 20Jan2021 02:00. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 20Jan2021. Therapeutic measures taken as a result of the events included Keflex times 10 days. No covid prior vaccination, no covid tested post vaccination, no other vaccine in four weeks. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported events cellulitis, fever, chills and swelling arm. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-02-09 lymph node swelling, lymph node pain Vaccine on Friday; Saturday around noon lymph nodes got tender & swollen. Then on Sunday became larg... Read more
Vaccine on Friday; Saturday around noon lymph nodes got tender & swollen. Then on Sunday became large (size of eggs), painful. Located in : Left interior Arm, L armpit, hand, Left neck up to ear, breasts, Left wrist, Right hand. Monday at 10 a.m. went to doctor. Ran tests to make sure nothing else was underlying. Came back negative. Started on hydroxovisil to reduce swelling. 2/10/21 physician called to notify that lab results were all negative so they feel it is due to COVID-19 Vaccine.
44 2021-02-09 swelling face fever 103.5 with chills, pounding headache, insomnia at first transitioning into extreme fatigue. b... Read more
fever 103.5 with chills, pounding headache, insomnia at first transitioning into extreme fatigue. bp 129/93 heart rate 115. Headache with flush face and arms and legs super heavy feeling on Sunday. Tuesday night experienced facial and head swelling, started in the middle of my forehead gradually filling up my entire head and face. Wednesday my whole face/eyes and head swollen, with tightness on my chest. My primary care provider prescribed methylprednisolone tablets USP Dosepak 4mg. I did take Benadryl and tylenol Tuesday. I also applied ice packs to my head and face. Headache still comes and goes with brain fog. Slight swelling remains on my forehead and eyes.
44 2021-02-10 lymph node swelling headache, sore arm, and swollen node(s) in the armpit of the same arm
44 2021-02-10 lymph node swelling Post-Vaccine Lymphadenopathy occurred 2 days after 2nd dose
44 2021-02-11 swelling Vaccination between 1:00 PM Five minutes after was itchy, numb, swelling up tongue 50 Mg Benadryl,... Read more
Vaccination between 1:00 PM Five minutes after was itchy, numb, swelling up tongue 50 Mg Benadryl, itchy to left hand, back head, and neck forty to fifty minutes. Take a dose of Benadryl around 8:00 pm . Itching lasted a week. Scratched the right lower leg and this created a raised bruise to that was sensitive to touch and lasted a week.
44 2021-02-11 swelling Severe redness, rash, swelling, headache, nausea, muscle weakness and aches, joint pain, shakes
44 2021-02-14 lymph node swelling Sore right underarm and right side of neck. Swollen lymph nodes right underarm, upper chest on righ... Read more
Sore right underarm and right side of neck. Swollen lymph nodes right underarm, upper chest on right side and right side of neck in front.
44 2021-02-14 peripheral swelling Body aches; Joints aches; Head Aches; Injection site pain; neck pain; Swelling of arm; pit of inject... Read more
Body aches; Joints aches; Head Aches; Injection site pain; neck pain; Swelling of arm; pit of injection side; severe fatigue, tiredness; chills; This is a spontaneous report from a contactable (patient). A 44-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 26Jan2021 at 01:30 PM as a single dose for COVID-19 immunisation, lot number: EL 1283. Medical history included quinolone antibiotics allergy. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021, 08:00 AM via an unspecified route of administration in Left arm for COVID-19 immunisation, lot number: EL1685. Concomitant medications in two weeks prior to the vaccination included ibuprofen, Tramadol, Meloxicam. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 26Jan2021 at 06:00 pm patient experienced body aches, joints aches, head aches, injection site pain, neck pain, swelling of arm, pit of injection side, severe fatigue, chills and tiredness. No treatment received for the events. Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the events, at the time of the report.
44 2021-02-16 lymph node pain, lymph node swelling low grade fever (100.4), chills, body aches, fatigue, swollen and painful lymph node under left armp... Read more
low grade fever (100.4), chills, body aches, fatigue, swollen and painful lymph node under left armpit
44 2021-02-16 swelling face within 15 minutes of Pfizer vaccine had itchy arms and facial twitching. She was observed for an hou... Read more
within 15 minutes of Pfizer vaccine had itchy arms and facial twitching. She was observed for an hour and was told to take benadryl as needed after leaving. Noticed facial rash later that night. The next day patient was itchy in both arms and has some facial swelling, does not have any trouble breathing. was taking benadryl every 4 hours, seen by allergist next day for telemedicine visit and was advised to switch to cetirizine, max 2 tab bid.
44 2021-02-17 lymph node swelling left side of my neck, where my lymph note is, it is swollen
44 2021-02-17 lymph node swelling This is a spontaneous report received from a contactable other healthcare professional (who is also ... Read more
This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0142, expiry date unknown), intramuscular in the left arm, on 05Jan2021 17:30, at single dose, for COVID-19 immunization, at the hospital. Medical history included asthma and high cholesterol. The patient has no allergy to medications, foot or other products. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included atorvastatin (LIPITOR) and ethinylestradiol, norgestrel (CRYSELLE). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient experienced upper left swollen lymph nodes (4) on 08Jan2021 13:30. The patient postponed 2nd shot until this is resolved. Ultrasound was done and was told biopsy was needed next. Therapeutic measures were taken as a result of upper left swollen lymph nodes (4) included ultrasound (as reported) on an unspecified date with unknown results. The event resulted to "doctor or other healthcare professional office/clinic visit". The outcome of the event was not resolved.
44 2021-02-17 lymph node swelling I am a travel RN and received the vaccine while working in TX. By 9 :00 am, I had a fever of 101 ... Read more
I am a travel RN and received the vaccine while working in TX. By 9 :00 am, I had a fever of 101 with body aches, chills, nausea, fatigue and abdominal cramps. By 11:00PM, my fever was 102.5 and I was in so much pain. I finally did take some medicine. About 24 hours after, the lymph nodes were swollen in my right arm pit. I couldn't turn my head because of the swollen lymph nodes in the right side of my neck.
44 2021-02-21 lymph node swelling Immediately after the injection became dizzy, light headed and nauseous. 24 hours later, I developed... Read more
Immediately after the injection became dizzy, light headed and nauseous. 24 hours later, I developed swelling in my right breast and lymph nodes in my right armpit. It is painful to the touch and swollen to the size larger than a golf ball. Pain radiates down my inner arm to my forearm.
44 2021-02-21 swelling face 1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat. ... Read more
1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat. 75mg Benadryl taken orally. - 1 hour later dizziness, heart rate 44, lost voice, face looked swollen. - 5 hours after vaccine administered went to outpatient clinic, heart rate 48 there. - After 1 hour, heart rate 120, sweaty, dyspnea and went to Emergency Room. 1/27/21-Amitted to Hospital -Given Solumedrol, Benadryl and Pepcid. Slowly improved. 1/29/21-Discharged Home on Pepcid 20mg BID x15 Days and PRN Benadryl. 2/8/21-Returned to work, but still has to take Benadryl daily for rash and uses Albuterol inhaler intermittently for "tightness" in throat.
44 2021-02-22 swelling face Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Swelling and ... Read more
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Swelling and redness in cheeks. Patient described feeling swelling in lips but no swelling was visible. She was given 25mg Benadryl and monitored for approximately an hour with no additional swelling seen and was driven home by a relative.
44 2021-02-23 lymph node swelling The morning after my injection, I woke up with swollen lymph nodes in my neck (on the left side) and... Read more
The morning after my injection, I woke up with swollen lymph nodes in my neck (on the left side) and at the base of my skull (in the back on the left side). I also had swollen tonsils. Additionally, the muscles in my shoulder, neck and head (on the left side- where I was given the injection) were tense and painful. It hurt to move them despite stretching them, massaging my shoulder and neck, applying ice to the areas to lower the swelling (for several hours), and ibuprophen. I am also fatigued, but I am told that this is a "normal" reaction to the vaccine. It is the second day and the swelling in my lymph nodes is less than yesterday, although they are still swollen, and the pain in my neck and shoulder is not as painful, but I still cannot turn my head quickly, and it is so stiff in the back of my neck that it hurts to lean my head back. I can lean my head back, but I have to take it very slowly, otherwise there is shooting pain.
44 2021-02-23 lymph node swelling 2/22 body aches, fever, rigors, fatigue 2/23 R axillary lymphadenopathy, pain in axilla, shoulder an... Read more
2/22 body aches, fever, rigors, fatigue 2/23 R axillary lymphadenopathy, pain in axilla, shoulder and arm, fever, fatigue, myalgias 2/24 low grade fever, otherwise same as 2/23
44 2021-02-23 lymph node swelling Enlarged painful lymph nodes on right side neck and body under arm. Hot arm, diarrhea, extreme fati... Read more
Enlarged painful lymph nodes on right side neck and body under arm. Hot arm, diarrhea, extreme fatigue, headache. My neck and underarm are still achy and enlarged. My body is still sore and I have not been able to continue with my daily activities. I have not felt like this since I had mono as a 19 year old. I have 5 children and have gone through natural childbirth 3 times. I?ve received all my vaccinations faithfully and have never in my life reacted this way. I am not getting the second dose until I have blood work done to see how my high my antibody levels are. I respect and am grateful for your work However I need to see data on my body?s reaction to even consider getting another dose.
44 2021-02-23 pancreatitis pancreatitis; This is a spontaneous report from a contactable Physician. A 44-years-old female pati... Read more
pancreatitis; This is a spontaneous report from a contactable Physician. A 44-years-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on arm left on 21Jan2021 07:00 at SINGLE DOSE for covid-19 immunisation. Medical history included migraines and seasonal allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), montelukast sodium (SINGULAIR), norethisterone (ORTHO MICRONOR) and topiramate (TOPAMAX). The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Dec2020 on left arm for covid-19 immunisation (age at vaccination: 44 years). The patient experienced pancreatitis, moderate mid-epigastric pain and elevated enzymes on 28Jan2021 18:00. The patient underwent lab tests and procedures which included enzymes: elevated on Jan2021 and labs: unknown result on an unspecified date. Therapeutic measures were taken as a result of pancreatitis, abdominal pain upper and elevated enzymes. Outcome of the events was recovered on Feb2021.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported pancreatitis with symptoms of moderate mid-epigastric pain and elevated enzymes and the administration of the COVID-19 vaccine, BNT162B2, considering the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
44 2021-02-25 lymph node swelling Sore arm; Sore neck; Swollen lymphnode under my left arm; This is a spontaneous report from a contac... Read more
Sore arm; Sore neck; Swollen lymphnode under my left arm; This is a spontaneous report from a contactable 44-year-old female consumer (patient). A 44-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via unknown route of administration, on 14Jan2021 at 10:00 AM (at the age of 44 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history included allergy to codeine, was diagnosed with COVID-19 prior to vaccination and had BNT162B2 vaccine dose 1 on unknown date, lot unknown. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications was not provided. The patient did not receive any other vaccines within 4 weeks or any medications within 2 weeks prior to the COVID vaccine. On 16Jan2021, at 08:00 AM, the patient experienced sore arm, sore neck and swollen lymph node under my left arm. No treatment was received for the events sore arm, sore neck and swollen lymph node under my left arm. The outcome of the events sore arm, sore neck and swollen lymph node under my left arm was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
44 2021-02-28 lymph node swelling Severe body aches started at 4:00am, could not get comfortable. Only thing that helped aches was the... Read more
Severe body aches started at 4:00am, could not get comfortable. Only thing that helped aches was the bath tub. Didn?t take temperature until 9:00am 100.9. Husband gave me Advil & Tylenol. Stomach ache/nausea came next, didn?t feel like eating. Very painful back ache shortly after that. Temperature kept fluctuating all day (due to Tylenol use). The next day (today 3-1-2021), I felt better, so I went to work. I noticed all day I getting the cold sweats. I was clammy most of the day, but didn?t feel tired. Took temperature after someone noticed I looked pale at work. My temp was 99.7. At around 4:30 I noticed my left armpit was hurting. Went home at 5:30 and relaxed. I told my husband my armpit was hurting around 10:30pm, I decided to Take my temp at 11:15pm and it was 97.6. I will see if the adverse side affects go away after today.
44 2021-02-28 peripheral swelling I woke up this morning with my hands swollen and bumpy with a red, rough rash. They do not itch.
44 2021-02-28 swelling face One minute after receiving the vaccine my face and tongue began to tingle. Then they began to swell.... Read more
One minute after receiving the vaccine my face and tongue began to tingle. Then they began to swell. The swelling lasted for 4 hours. 16 hours after the vaccine I had a fever of 101 degrees Fahrenheit, chills, muscle aches, a headache, and I was vomiting. This lasted for 36 hours.
44 2021-02-28 swelling, peripheral swelling Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itchin... Read more
Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response. 02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine. 02.04.21 Pt presents to Ed with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
44 2021-03-01 lymph node swelling Within 12 hours had fevers, chills, sweat, myalgia, HA, and axillary LN (size of golf ball). These s... Read more
Within 12 hours had fevers, chills, sweat, myalgia, HA, and axillary LN (size of golf ball). These sx eventually improved. 72 hours latter diffuse macularpapular rash on trunk, inguinal region, back.
44 2021-03-01 lymph node swelling Underarm and breast tenderness as well as swollen lymph nodes on the same side as vaccination
44 2021-03-02 anaphylactic reaction Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP... Read more
Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP = 180/120/her BP was high; feeling lightheaded; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot: EN6201, expiry: Jun2021), intramuscular (IM) on left (L) arm (at the age of 44years) on 16Feb2021 at 12:00 at single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (lot: EN5318, expiry: Jun2021) IM on L arm on 28Jan2021 at 14:45 that 45 minutes after administration (on 28Jan2021) the patient experienced tingling sensation on lip which was with diphenhydramine hydrochloride (BENADRYL) as treatment and recovered on unspecified date. Medical history included hypertension, allergic to fish (treatment were adrenaline (EPIPEN), corticosteroid and antihistamine) and ongoing BP. Concomitant medications included ongoing hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) and ongoing unspecified Vitamins daily. The patient previously took prochlorperazine maleate (COMPAZINE) and metoclopramide (REGLAN) which were medications she took while pregnancy, gabapentin and hydromorphone hydrochloride (DILAUDID) where the patient experienced allergies from these drugs and treatment were adrenaline (EPIPEN), corticosteroid and antihistamine. There was no covid prior vaccination and was covid tested post vaccination with Nasal Swab (Sofia SARS Antigen) on 04Feb2021 with result of negative. The patient experienced severe anaphylaxis attack on 16Feb2021 at 12:30 (30 minutes after the administration of 2nd dose) which resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event) with treatment included Intravenous IV diphenhydramine hydrochloride (BENADRYL) + prednisone + famotidine (PEPCID), GI cocktail, Heart monitoring. The HCP (patient) was on observation for 30 minutes when she started with tingling sensation, sweating and feeling hot (in Feb2021). They took BP=180/120 (in Feb2021). They administered IV diphenhydramine hydrochloride + prednisone + famotidine. She was feeling lightheaded (in Feb2021). She stayed in observation for 4 hours until recovered. She was sent home and prescribed prednisone and loratadine (CLARITIN) daily. HCP stated that she has an episode yesterday (16Feb2021), she was feeling tired, the sweating came back and her BP was high. Today (19Feb2021) her BP was stable. The patient reported tachycardia under information on organ involvement (in Feb2021). The patient required medical intervention but not hospitalized nor admitted to an intensive care unit. No other vaccine in four weeks and no other medications in two weeks. The patient did not receive any recent vaccines for any other conditions prior to the events and did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the events. The outcome was recovered for the events anaphylaxis and dizziness both in Feb2021, and hypertension on 19Feb2021 while for the remaining events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Anaphylaxis cannot be excluded. The case will be reassessed if additional information becomes available.
44 2021-03-02 swelling Lower lip angioedema. Patient has history of angioedema caused by ACE inhibitor and lip fillers also
44 2021-03-02 swelling face 2/25/21 11:36 AM Patient states that her symptoms (swollen around left eye to her throat, right side... Read more
2/25/21 11:36 AM Patient states that her symptoms (swollen around left eye to her throat, right side of her face feels fine, tight through, light bumpy rash on her chin) increased over the last hour and now do not seem to be getting worse. She is able to breathe without difficulty. She will take 50 mg Benadryl and if symptoms progress she will go to the ER for further treatment and evaluation of an allergic reaction to COVID vaccine. She will call Dr. back later and may need note for work. 2/26 11:30 AM Received text message from patient. "I woke up with trouble breathing, hives on my neck and jaw and swollen face. Nausea and diarrhea. Trouble swallowing so I took Benadryl. Swelling went down on face but still tight in throat. . Dr. "instructed her to go to ER if symptoms worsen and told her I would check on her on Monday. I asked her if her symptoms were not changed, worse, or improved. She answered: "They got worse this am from 5 to 10 and feeling better now. As far as swelling and breathing feels better. 3/1 10:21 AM Dr. Spoke with patient 10:21 am. She states that she is feeling much better and no longer has difficulty breathing or feeling of throat tightness. She does still have nausea, with occasional vomiting, and diarrhea. She felt well enough to return to work today. 3/3 11:09 AM Dr. spoke with patient. She stated that she is finally feeling "back to normal". We discussed severity of side effects and recommendation to defer 2nd Pfizer vaccination. She stated that at one point she was "close to going to the ER".
44 2021-03-02 swelling Within minutes, Xavier felt burning sensation but did not report it while she was in the observation... Read more
Within minutes, Xavier felt burning sensation but did not report it while she was in the observation room because she thought it will go away just like it did with first dose. She then started to have rashes, low grade fever, and felt weak same day, and went on the following day. On 2/21/21 she had generalized swelling and rashes, difficulty breathing and went to the hospital.
44 2021-03-04 oral herpes I have a history of fever blisters and have infrequent flare ups during or after illness or in time... Read more
I have a history of fever blisters and have infrequent flare ups during or after illness or in times of stress or too much sun. I got a fever blister on my lip on Friday following my vaccine the Tues before. Not sure if they are connected but wanted to report.
44 2021-03-07 lymph node swelling Extremely sore arm for 3 days Nauseous for 4 days Lymph nodes under left arm swollen and very tender... Read more
Extremely sore arm for 3 days Nauseous for 4 days Lymph nodes under left arm swollen and very tender for 5 days
44 2021-03-07 lymph node swelling After 10 minutes of my first dose vaccine, I began to experience chest pain and could not breathe. I... Read more
After 10 minutes of my first dose vaccine, I began to experience chest pain and could not breathe. I felt nauseated. My BP went up to 150 and staff was monitoring me, my normal BP is 90/110. After two hours I started to feel dizzy, nauseated and i was in the ER room for four hours. I felt like passing out, my BP was 169/69 and my heart rate was also high. Then I started to feel cold and began to shivering while an EKG was performed. My BP never went down. After one week and for four days I had fever and weakness to my body also from my knees down felt weakness. Also one week after my vaccine, my lymph nodes got swollen, left ear. I communicated these symptoms to my PCP of my reactions.
44 2021-03-08 lymph node swelling Swollen lymph nodes on left side of neck and terrible sore throat only on the left side as well.
44 2021-03-08 swollen extremities 1/7/21-1/9/21: fevers consistent >39.5 x 36hrs 1/7/21- 1/8/21 extreme nausea and vomiting--nausea ... Read more
1/7/21-1/9/21: fevers consistent >39.5 x 36hrs 1/7/21- 1/8/21 extreme nausea and vomiting--nausea has continued daily, vomiting is decreased to 2-3 days/week. Zofran 8mg has been used as needed 2/8/21 ALT164, AST 156 (increased from post vaccine January '21) Aldolase 10.2, CK 199, Alk Phos and Bilirubin normal, WBC and neutrophil sudden decrease. UA 4+ bacteria epith cells and protein... worsening but negative culture 1/2021palpitations and chest pain intermittent but no respiratory distress Other Items: petechial rash to lower flank and extremities, facial rash, peripepheral edema, rash, and pain consistent with vascular inflammation. Right temporal lobe painful to touch. Neck pain. Throat pain and difficulty swallowing
44 2021-03-09 lymph node pain, lymph node swelling lymph node under my left arm, close to my left breast is swollen; it is sore; felt chills; injection... Read more
lymph node under my left arm, close to my left breast is swollen; it is sore; felt chills; injections site pain; tiredness; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 11:15 (Lot number: EN5318) via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included high blood pressure from an unknown and unknown if ongoing. Concomitant medications included lisinopril, amlodipine, metoprolol and levocabastine hydrochloride (Zyrtec). The patient had no allergies to medications, food or other products. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that the lymph node under his left arm, close to his left breast was swollen. The patient also felt chills, injections site pain, and tiredness on 27Jan2021 04:00. The events assessed as non-serious by the reporter. It was unknown if the patient received treatment. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
44 2021-03-11 lymph node swelling Developed significant lymphadenopathy L axilla, L clavicle area, L breast with L breast swelling (3 ... Read more
Developed significant lymphadenopathy L axilla, L clavicle area, L breast with L breast swelling (3 inch increase in chest circumference). Pain and tenderness.
44 2021-03-12 anaphylactic reaction Pt walked up to staff c/o itchy & swelling to throat & tongue. Staff assessed pt & vitals. Pt presen... Read more
Pt walked up to staff c/o itchy & swelling to throat & tongue. Staff assessed pt & vitals. Pt presents with anaphylaxis & hypertension. Staff gave ALS care and administered 50mg Benadryl IM & EPI 0.3 mg IM. Due to no improvement, staff gave O2 prior to 2nd EPI dose. Staff transported pt to Hospital. EOR.
44 2021-03-12 swelling SOB, throat tightness 5 minutes after vaccination 4 mg decadron, epi and benadryl given IM on scene ... Read more
SOB, throat tightness 5 minutes after vaccination 4 mg decadron, epi and benadryl given IM on scene transferred to Emergency room via ambulance C/) SOB, itching and swelling at the back of her throat and in her neck. No hives. No syncope. Described as moderate and later mild. No radiation, no vomiting, no wheezing. Patient discharged from ED at 09:30 am
44 2021-03-13 swelling face Hives at injection site and across chest and neck, shortness of breath, minor swelling of face and t... Read more
Hives at injection site and across chest and neck, shortness of breath, minor swelling of face and throat as symptoms progressed.
44 2021-03-14 lymph node swelling Sleeplessness throughout the night.; aches with no fever 12 hours after the vaccination. / aches wi... Read more
Sleeplessness throughout the night.; aches with no fever 12 hours after the vaccination. / aches with no fever 24 hours after vaccination lasting 12 hours; Chills; Swollen lymph node in armpit of vaccinated arm 48 hours after vaccination.; Vivid nightmares 14 hours after vaccination.; This is a spontaneous report from a non-contactable other healthcare professional (patient). A non-pregnant 44-years-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL3247, via an unspecified route of administration on 06Feb2021 09:45 (at the age of 44 years old) at SINGLE DOSE in the left arm for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient had no allergies.Historical vaccine information included BNT162B2, Lot EL9269, on 16Jan2021 10:00 AM in the Left arm, Dose number 1. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Feb2021 21:00, the patient experienced chills and aches with no fever 12 hours after the vaccination, sleeplessness throughout the night. The chills and aches with no fever 24 hours after vaccination lasting 12 hours. Patient experienced vivid nightmares 14 hours on unspecified date in Feb2021 after vaccination. Patient experienced swollen lymph node in armpit of vaccinated arm 48 hours on unspecified date in Feb2021 after vaccination. No treatment was received for the events. Outcome of the vivid nightmares, Ache , Sleeplessness throughout the night, chills, Swollen lymph node in armpit was recovered in Feb2021. No follow up attempts are possible. No further information is expected.
44 2021-03-15 lymph node pain, lymph node swelling After receiving my first dose I experienced the following adverse side effects: -Fatigue -Extreme so... Read more
After receiving my first dose I experienced the following adverse side effects: -Fatigue -Extreme soreness in my arm -The lymph nodes under my arm pit was swollen and tender -I broke out in hives on my hands and face -I had a rash on my tongue -A knot on the bottom of my right foot [in the area of the arch] -The skin on both of my hands have been peeling extremely bad
44 2021-03-15 oral herpes, lymph node swelling lymph nodes under arm pits feel like golf balls was reported as worsened/lymph nodes under arm feel ... Read more
lymph nodes under arm pits feel like golf balls was reported as worsened/lymph nodes under arm feel like golf balls was reported as worsened; lymph nodes under her arm pits and under her arm feel like golf balls/lymph nodes in neck swollen; Fever is 99.6 this morning; hurt all over from her toes to her fingers and from her fingers to her toes; lack of sleep; Headache; Chills; feels like wires are squeezing and pressing her/Feels awful; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Feb2021 13:00 at single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia Diagnosed with it 5-6 years ago, ongoing chronic lymphocytic leukaemia Diagnosed almost a year ago. The patients concomitant medications were not reported. The patient experienced, lack of sleep on 05Feb2021 21:00. It was reported that she got the vaccine more than 48 hours ago. Stated that she feels awful on 05Feb2021 10:00. Stated that she has a fever on 06Feb2021, chills and headache on 05Feb2021 19:00, hurt all over from her toes to her fingers and from her fingers to her toes on 05Feb2021 22:00. Stated that she is in a lot of pain and that it feels like wires are squeezing and pressing her on 05Feb2021. Stated that it is horrible. Stated that the lymph nodes under her arm pits and neck feel like golf ball under arm and arm pit on 06Feb2021 12:00. Stated today the doctor will see her because it will have been 3 days in a few hours. Clarified that this is for the Covid vaccine. Stated that she is working in a retirement place with an older person. Stated that they decided to give to it to her. Stated that she asked her doctor and he told her that it was okay. Later clarified that the lymph nodes in her neck are just swollen and the lymph nodes under her arm pits and under her arm feel like golf balls. Stated that her fever is 99.6 this morning (06Feb2021). Stated that it improved when she took three Advil (600mg). Stated that she feels like wires are squeezing and pressing her again when the Advil wears off. Was told to alternate with Tylenol and is taking a lot of liquids. Clarified that she thought that the pain was fibromyalgia but that it felt worst than fibromyalgia. Stated that the lack of sleep improved because she takes a higher dosage of Advil or Ibuprofen for sleep. Outcome of the event fever is 99.6 this morning, hurt all over from her toes to her fingers and from her fingers to her toes, feels awful, lack of sleep recovering. Outcome of the event lymph nodes under arm feel like golf balls was reported as worsened (Condition worsened) was unknown. Outcome of the other events was not recovered. Information on the lot/batch number has been requested.
44 2021-03-15 swelling Swollen shoulder and pain. Swollen eyes and face.
44 2021-03-15 swelling Large swollen lump in groin area (left leg), irritated during day from sitting and was pussing white... Read more
Large swollen lump in groin area (left leg), irritated during day from sitting and was pussing white liquid at night for about a week.
44 2021-03-17 lymph node swelling Swollen lymph node and pain in left armpit
44 2021-03-17 lymph node swelling Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, INJECTION SITE PAIN, SWOLLEN GLANDS Narrative:
44 2021-03-17 swelling face every where she had had filler injections are swollen except the left eye, her left eye is not swoll... Read more
every where she had had filler injections are swollen except the left eye, her left eye is not swollen; every where she had had filler injections are swollen except the left eye/her doctor believes she is having a reaction with her fillers/bump on her right eye; under her right eye there was a large bump that was swollen; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via an unspecified route of administration in the left upper arm, on 07Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included Hashimoto's disease from 2017 and ongoing, cosmetic filler injections got in her face within the last year and half or 2 years. Patient said that she knew that Allergan asked her doctor about her ongoing Hashimoto's as well. She takes medication for that. Patient also said that her white blood cell count runs low, like around 2 if they want to note that as an immune system thing and she confirmed that was an issue for her prior to receiving the COVID 19 vaccine. Family medical history included that her daughter has Hasimotos as well. Concomitant medications included unspecified medications for Hashimoto's disease. The patient previously received first dose of BNT162B2 (lot number: EI1685) via an unspecified route of administration in the left upper arm on 18Dec2020 at the year of 44 years at single dose for covid-19 immunisation. She said her doctor believes she is having a reaction with her fillers. She clarified fillers were like cosmetic injections got in her face. She thought the filler was called Allergan but she didn't have any other information about it. She did know her doctor did call Allergan and did a report with them. She thought it was like a big deal because it was not documented with Pfizer just with Moderna. She said the doctor was also going to call and report this as well. The doctor has not called yet but he said he was going to, she just left their office. Basically the places she had had filler injections within the last year and half or 2 years not have, under her right eye there was a large bump that was swollen and then the places that were called labial folds, the marionette lines where she had had filler there were all swollen and that was on the right side of her face and then on the left side the marionette lines were swollen as well so basically everywhere she had had filler injections were swollen except the left eye, the left eye is not swollen. And the places were swollen and hard. She first noticed the swelling yesterday 25Jan2021. The bump on her right eye was yesterday around 15:00 and then this morning (26Jan2021) it was much worse under her eye and she noticed the bumps on the right side at about 6 am this morning and around 9 am she began feeling it on the left side and it progressively has gotten worse since it started in all of those areas (26Jan2021). This case reported as serious. Patient did not visit Emergency Room, but she has been to 2 different physicians in physician office. No other vaccines administered on the same day as either dose of the suspect product. Patient did not have prior vaccinations within 4 weeks. Outcome of the events was not recovered. Reporter assessed event everywhere she had had filler injections are swollen except the left eye, her left eye is not swollen as related to BNT162B2.; Sender's Comments: Based on available information a contributory role of BNT162B2 to reported events cannot be fully excluded. Consideration should also be given to the contribution from the cosmetic filler injections. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
44 2021-03-20 lymph node swelling Swollen Lymph nodes under left Armpit ongoing Extreme Fatigue ongoing Low grade fever for 1 day Body... Read more
Swollen Lymph nodes under left Armpit ongoing Extreme Fatigue ongoing Low grade fever for 1 day Body aches and chills for 1 day
44 2021-03-21 lymph node swelling, lymph node pain Shot at 10:30 AM Thursday, experienced intense soreness in right arm (far worse than the 1st shot in... Read more
Shot at 10:30 AM Thursday, experienced intense soreness in right arm (far worse than the 1st shot in left arm) and by mid-afternoon headache. Overnight woke with fever, chills, headache and sore arm making sleep impossible. Ill all day Friday - fever, chills, fatigue, no appetite, headache, arm soreness. Friday evening awoke with intense pain in right arm pit, breast, upper ribs - extremely swollen lymph nodes (size of avocado). Extremely tender and sore. Pain continued throughout Saturday, Sunday, and now into Monday. Also still fatigued and feeling run down.
44 2021-03-21 peripheral swelling, swelling Symptoms started on 03.15.3022. Swelling on right arm at crook, nothing at injection site. Poc mar... Read more
Symptoms started on 03.15.3022. Swelling on right arm at crook, nothing at injection site. Poc marks developed as well where swelling was, armpits, shoulder blade and legs all right side. Swelling increased became very red and hot to touch, itching all where marks were. I was taking Benadryl and applying cortisone cream. On Friday went to walk in, advised not much they can do stop taking Benadryl. On 0321.2021 hives broke out all on right arm started Benadryl again. Still have them now over a week later.
44 2021-03-25 anaphylactic reaction Anaphylaxis: Shortness of breath, chest tightness, itching, muscle spasm
44 2021-03-26 anaphylactic reaction Immediate metallic taste in the mouth. Anaphylactic reaction starting after 5 minutes (high heart ra... Read more
Immediate metallic taste in the mouth. Anaphylactic reaction starting after 5 minutes (high heart rate, difficulty swallowing, tight feeling in chest).
44 2021-03-26 lymph node swelling Awoken during sleep (around 12 am the next day) with chills and elevated temperature. Did not sleep ... Read more
Awoken during sleep (around 12 am the next day) with chills and elevated temperature. Did not sleep rest of night/early morning. Developed all over body aches, chills subsided by noon on same day they began. Injection site swelled, and was very red. Swelling spread to underarm/lymph node area. Headache began in early morning on day after shot as well, and nausea set in as well. Slept most of day, ran fever, was nauseous, and achy. The second day after the vaccine was improved - no headache, appetite returned, fever was better. Arm and underarm was still red, swollen and sore, and had overall tiredness and still achy. The only lasting side effect was the red, swollen, and sore arm, which is now almost back to normal. There is still some soreness in the arm and underarm, but the redness and swelling is gone as of 3/22.
44 2021-03-26 swelling face My arm became very hot later in the night and then my face got really hot and when I woke up my face... Read more
My arm became very hot later in the night and then my face got really hot and when I woke up my face was swollen like I had a mild reaction
44 2021-03-26 white blood cell count increased She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swel... Read more
She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swelling and vocal changes with wheezing within 15 minutes of receiving the vaccine. She was treated with benadryl and albuterol and sent home after improvement. After going home, continued to have some lip/throat swelling. She then presented to local hospital with worsened symptoms, treated with benadryl and steroids, given a script for prednisone, and sent home. She did not fill the prednisone script initially, but had some prednisone (unknown strength) at home and took a pill. The following morning (3/26), she continued to have throat and lip swelling and began to develop some dyspnea. Due to these worsening symptoms, she came to ED. She received a total of 5 doses of IM epinephrine (1734, 1938, 2010, 2320, 0017) along with IV pepcid and IV solumedrol for persistent subjective throat swelling, dyspnea, and difficulty tolerating secretions. She was admitted to the ICU for close monitoring of symptoms and consideration of an epinephrine drip, but did NOT require this. In the morning of 3/27, she noted substantial improvement in symptoms of tongue/lip swelling, improved wheezing, dyspnea, and dysphagia. Still with some mild hoarseness that she attributes to cough, also improving.
44 2021-03-28 lymph node swelling Patient?s left: Dorsal shoulder pain , inflammation of lymph nodes.
44 2021-03-29 lymph node swelling body aches, headache, and swollen axillary lymph nodes 44 year old female (DOB: 11/08/1976) receive... Read more
body aches, headache, and swollen axillary lymph nodes 44 year old female (DOB: 11/08/1976) received the 2nd dose of the Pfizer COVID-19 vaccine at Track on 03/26/2021 @ 13:30. Pt started experiencing body aches, headache, and swollen axillary lymph nodes on 03/26/2021 @ 21:00. Pt takes Diltiazem 120mg and Omega-3 supplement. Pt has microvascular dysfunction cornary vasospasm. Pt is allergic to Percocet, does not remember whether doctor specified the allergy was to oxycodone/opioid. Pt has not taken opioids since percocet reaction. Pt has taken Tylenol several times since percocet reaction, and has not experienced any side-effects or allergic type reactions. Pt prefers IBU because of the longer lasting effects. Allergy was likely related to opioid/oxycodone. Pt was advised to take Tylenol, monitor axillary lymph nodes, and if headache worsens, axillary lymph nodes swelling increases, or symptoms do not alleviate in 2 days to contact primary doctor for medical care. was consulted and Dr. was notified.
44 2021-03-30 anaphylactic reaction 20 minutes after injection, started feeling itchy all over. Began coughing and having asthma, used i... Read more
20 minutes after injection, started feeling itchy all over. Began coughing and having asthma, used inhaler twice with no relief, was taken from coliseum by ambulance to ER. Enroute given epinephrine and 50 ml of benadryl. At ER repeat epinephrine and benadryl, H1/H2 blockers given. Released after three hour observation. Diagnosis of anaphylaxis.
44 2021-03-30 anaphylactic reaction Anaphylaxis; This is a spontaneous report from a two contactable consumer (patient and office assist... Read more
Anaphylaxis; This is a spontaneous report from a two contactable consumer (patient and office assistant). A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6208), via an unspecified route of administration in left arm on 12Mar2021 at 18:30 as a single dose for COVID-19 immunization. Medical history included hypothyroidism, bipolar and high blood pressure. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was unknown if patient had covid prior vaccination. Concomitant medication included lamotrigine (LAMICTAL), levothyroxine (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and glucosamine (MANUFACTURER UNKNOWN). On 12Mar2021 at 18:45, the patient experienced anaphylaxis. It was reported that patient visited emergency room/department or urgent care. The patient took Benadryl and 2 epinephrine shots as a treatment. It was reported that COVID test was not done after post vaccination. The outcome of the event was resolved on Mar2021.
44 2021-03-30 lymph node swelling bumps on lymph node; This is a spontaneous report received from a contactable consumer (patient). A ... Read more
bumps on lymph node; This is a spontaneous report received from a contactable consumer (patient). A 44 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) first dose on 03Mar2021 via an unspecified route of administration as single dose for COVID-19 immunisation. Patient medical history and concomitant medication were not reported. Patient stated that she was due to receive second dose but was reporting bumps on lymph node on an unspecified date. Outcome of the event was unknown. Information on the lot/batch number has been requested.
44 2021-04-01 anaphylactic reaction Patient presents 1 day after anaphylactic reaction (throat swelling, congestion, hives, nausea, SOB)... Read more
Patient presents 1 day after anaphylactic reaction (throat swelling, congestion, hives, nausea, SOB) after running outside around a lake. No previous history of anaphylaxis or allergies. Reports that she had her COVID-19 vaccine 1 week ago. and had question about if that could have contributed to the event.
44 2021-04-01 swelling face Swollen tongue, facial swelling, sore throat, headache>>>allergic reaction lasted 5 days; responded ... Read more
Swollen tongue, facial swelling, sore throat, headache>>>allergic reaction lasted 5 days; responded to Benedryl and Claritin. Headache continues off and on for 2 weeks.
44 2021-04-02 swelling face On 4/2/21, arm pain, body aches, bad headache, chills, fatigue, redness at injection site. At about ... Read more
On 4/2/21, arm pain, body aches, bad headache, chills, fatigue, redness at injection site. At about 7:30 pm, I started feeling bruising under my right eye. At about 9:30 pm, I had a small bump under my left eye. On 4/3/21, I woke up with facial swelling. I was swollen underneath my eyes, cheeks were swollen, and lip was swollen. Headache, slight back ache, redness at injection site and sore injection area continue. Took 2 Benadryl at 9:00 am to reduce swelling.
44 2021-04-02 white blood cell count increased Started with normal sore arm and headaches transitioned to diarrhea and fever. Tinnitus set in on Th... Read more
Started with normal sore arm and headaches transitioned to diarrhea and fever. Tinnitus set in on Thursday morning and has continued since then. Friday night I experienced a loud pop on the left side of my head - pressure released on the left year slightly followed by numbness and tingling in face along with blurred vision, dizziness and weakness in left leg. Blurred Vision lasted maybe 1-2 minutes, numbness and weakness/dizziness resolved on ride to ER so maybe 10 minutes as we live near the hospital. ER evaluated me for potential stroke. Cat scan and labs done. Nothing odd was noted. Doc decided it was parethesia of left leg and nonintractable episodic headache event. Blood pressure was elevated which is unusual for me along with a high White blood cell count- Doc said this is normal with just having received a vaccine recently. No concerns with platelets or enzymes and electrolytes. Doc does think it could be vaccine related as that is the only thing new this week. Due to earlier in the week side effects, my PCM did COVID test me just incase since the side effects were hanging around longer than the normal window of time and nasal swab PCR came back negative.
44 2021-04-03 lymph node swelling, lymph node pain At the 36 hour mark clavicle lymph node swelled to a gum ball size, palpable and extremely painful. ... Read more
At the 36 hour mark clavicle lymph node swelled to a gum ball size, palpable and extremely painful. As of this claim, still large and pain had reduced by 25%
44 2021-04-03 swelling Painful swelling in left armpit. Fatigue. Headache.
44 2021-04-05 lymph node pain Fever (100-101.2), chills, body aches, large swollen lymph node in left arm pit starting at 4am. Fev... Read more
Fever (100-101.2), chills, body aches, large swollen lymph node in left arm pit starting at 4am. Fever continued to get higher throughout the day. I had a headache first thing in the morning but it didn?t return. Lymph node was sore to touch or lay on.
44 2021-04-06 anaphylactic reaction Vaccine administered around 0850, approximately at 0854 patient notified provider with symptoms of a... Read more
Vaccine administered around 0850, approximately at 0854 patient notified provider with symptoms of anaphylaxis reaction. Patient brought to private room, notice symptoms of generalize rash. Vital signs taken at 0902 BP: 142/82 HR:102 O2: 100%. Administered Benadryl 50mg/mL at 0902 Lot number: 6020111 Exp: 07/21. Patient expressed tightness of throat with audible wheezing, immediately administer EPI Pen 0.3 mg/mL Lot number: 0FN1407 Exp: FEB2022 on the left thigh. Patient improving symptoms. FED FIRE was called at 0901, arrived at 0908, transported at the Hospital at 0912.
44 2021-04-06 lymph node pain I had my second shot yesterday afternoon and after 2am the following morning, I had a pretty severe ... Read more
I had my second shot yesterday afternoon and after 2am the following morning, I had a pretty severe reaction. Chills, sweat, body aches, vomiting, but what was most concerning was I could feel intense pain in all my joints and lymph nodes. Wondering if the severity was due to my auto-immune disorder. I feel a bit better this morning but I have a wandering internal pain that seems to flare for a few seconds in different body parts: ear, foot, hip.
44 2021-04-07 swelling Day 1 headache and nasuea that subsided by 7 PM. 1 week later started having sensitivity and pain in... Read more
Day 1 headache and nasuea that subsided by 7 PM. 1 week later started having sensitivity and pain in scalp with headaches. On 3/27 I had a bump on back of neck. 3/28 rash appeared on left side of neck and on face along jawline. I also had painful sores appear in my scalp on left side.
44 2021-04-08 lymph node swelling Severe swollen armpit on side of injection massive headaches fatigue and breast swelling on side of ... Read more
Severe swollen armpit on side of injection massive headaches fatigue and breast swelling on side of injection. Slight cough, throat closure feeling
44 2021-04-08 lymph node swelling Sore arm and hot that evening. The next day - body aches, prickly skin, joint pain, swollen lymph no... Read more
Sore arm and hot that evening. The next day - body aches, prickly skin, joint pain, swollen lymph nodes (sore in armpits and behind ears), extreme tiredness, less alert, more irritable.
44 2021-04-08 lymph node swelling 1. Within first 15 minutes - burning at injection site; resting heart rate rapid/ increased and rec... Read more
1. Within first 15 minutes - burning at injection site; resting heart rate rapid/ increased and recorded by staff to 130's; trembling 2. 9-10 days after injection; swollen lymph node and discomfort in armpit of same arm where injection occurred
44 2021-04-09 lymph node swelling Swollen lymph node in left arm pit. Lymph nodes has swollen to golfball size. It?s uncomfortable, b... Read more
Swollen lymph node in left arm pit. Lymph nodes has swollen to golfball size. It?s uncomfortable, but not painful.
44 2021-04-09 swelling face Painful Facial swelling on chin, lips, cheeks
44 2021-04-09 swelling Ringing in ears, swollen glands in neck, joint pain, throbbing pain at injection site, swelling at i... Read more
Ringing in ears, swollen glands in neck, joint pain, throbbing pain at injection site, swelling at injection site, stomachache, fever, chills causing uncontrollable shaking, exhaustion, shooting pains from elbow to hand of non-injection arm, runny nose
44 2021-04-10 lymph node swelling, lymph node pain Arm pain at injection site. Continuous from 4/9 at 9pm. Fever 99-101, with body aches, from 4/10 ... Read more
Arm pain at injection site. Continuous from 4/9 at 9pm. Fever 99-101, with body aches, from 4/10 2pm-4/11 4am Swollen lymph node in left armpit, with pain. Onset 4/10 at 5pm.
44 2021-04-10 lymph node swelling Chills started around 11pm - took Tylenol and went to bed Stayed in bed for 18 hours - took a total ... Read more
Chills started around 11pm - took Tylenol and went to bed Stayed in bed for 18 hours - took a total of 3 rounds of Tylenol - every six hours Fever was around 101 - and it dropped and spiked again about 3 times Lymph nodes in my right armpit were swollen Headache and nausea most of the day on Saturday April 10, along with fevers and chills; cold compress and Ibuprofen helped. Around 6 or 6:30 I was up and moving slowly. Fine this morning after another night of sleep.
44 2021-04-11 lymph node swelling, lymph node pain Received 1st dose on April 1 @ approximately 3:45pm. The next few days only side effects were a ver... Read more
Received 1st dose on April 1 @ approximately 3:45pm. The next few days only side effects were a very sore arm and slightly tired. On April 9th, 8 days after receiving the 1st vaccine around 12pm noon I became extremely fatigued. By 10pm on April 9th I had a fever of 100.2. At 3am on April 10th I had chills and my fever broke. On April 10th my lymph nodes on the left side of my face under my left ear and under my left armpit became very swollen and tender and sore, and remain swollen and sore as of the writing of this email on April 12th. I?ve had no further fever.
44 2021-04-11 lymph node swelling Pt diagnosed with Herpes Zoster. The patient developed new onset rash around 3/29/2021 with lymphade... Read more
Pt diagnosed with Herpes Zoster. The patient developed new onset rash around 3/29/2021 with lymphadenopathy and associated itching and rash on left antero-lateral neck and left side of scalp. The rash appeared along the C2 dermatome distribution. Lymphadenopathy was located at left occipital scalp. The lesions were beginning to crust over at the time of visit, but she was diagnosed clinically with Herpes Zoster by myself. She was empirically started on Valacyclovir 1 gram TID x 7 days, starting on 04/08/2021, the date of diagnosis. She was also given Triamcinolone 0.1% cream for symptom control. She is now feeling much better and received her second dose of the Pfizer Covid-19 vaccine today. So far, she has not experienced any new or worsening side effects from the second dose. Overall her Herpes Zoster case was mild in severity.
44 2021-04-11 lymph node swelling SYMPTOMS BEGAN AROUND 10PM LATER THAT NIGHT. NECK GLANDS SWOLLEN, TONGUE HAD SMALL RED BUMPS, LIGHT ... Read more
SYMPTOMS BEGAN AROUND 10PM LATER THAT NIGHT. NECK GLANDS SWOLLEN, TONGUE HAD SMALL RED BUMPS, LIGHT SENSITIVITY, SKIN BURNT FOR A SHORT WHILE APPROX. ONE HOUR. LOOSE STOOL IN AM. 4/9-she awoke with abd pain this AM. Caller states she awoke with what felt like her usual allergy flare-up sx and wondering if related. Spoke with patient; states previous sx are gone however feels like usual allergy flare-up is happening. RN rec she contact her PCP or go to urgent care for further testing and assessment.
44 2021-04-11 peripheral swelling Low fever, body aches, chills, nausea, swelled armpit, stomach ache, headache
44 2021-04-12 lymph node swelling fatigue first day, by 2nd-3rd day sore with body aches and left side foot, knee, hip pains and shoot... Read more
fatigue first day, by 2nd-3rd day sore with body aches and left side foot, knee, hip pains and shooting pains up and down back of neck. Went to drs office on 4/12 and discovered swollen lymph nodes. Head aches every day since vaccine.
44 2021-04-12 lymph node swelling The morning extreme chills with a red, hot, hard 3"x4" localized reaction. Ran fevers for three days... Read more
The morning extreme chills with a red, hot, hard 3"x4" localized reaction. Ran fevers for three days with the highest 103.5. The localized reaction continued to grow to 4"x4" with swollen lymph needs in that axilla.
44 2021-04-12 peripheral swelling A knot arose overnight at the vaccination site on my upper left arm. The knot is very red. The sur... Read more
A knot arose overnight at the vaccination site on my upper left arm. The knot is very red. The surrounding area is swollen, hot to the touch and very painful. I woke up from the pain several times after midnight when I rolled onto my left side. I do not plan to seek medical attention.
44 2021-04-13 lymph node swelling, lymph node pain Left Lymph Node is Very Swollen and painful. Started 5 fats after shot. It has been the same for 5 ... Read more
Left Lymph Node is Very Swollen and painful. Started 5 fats after shot. It has been the same for 5 days so far
44 2021-04-14 lymph node swelling Received the 2nd shot in my left arm a 8am Saturday morning. By early afternoon was experiencing som... Read more
Received the 2nd shot in my left arm a 8am Saturday morning. By early afternoon was experiencing some pain in my right armpit. By that evening I could feel an a lump/mass growing in my armpit. It proceeded to get larger, to a golf ball size, and more painful through Monday. The pain made it difficult to lift or move my right arm. Any contraction of my bicep muscles would trigger pain. Proceeded to make a doctor's appointment for Tuesday, April 13th.
44 2021-04-14 swelling face throat itching, facial swelling, allergic reaction requiring Epipen, Benadryl, Solumedrol and monit... Read more
throat itching, facial swelling, allergic reaction requiring Epipen, Benadryl, Solumedrol and monitoring
44 2021-04-15 anaphylactic reaction What: Anaphylaxis reaction. Vaccine administered around 0850, approximately at 0854 patient notified... Read more
What: Anaphylaxis reaction. Vaccine administered around 0850, approximately at 0854 patient notified provider with symptoms of anaphylaxis reaction. Patient brought to private room, notice symptoms of generalize rash. Vital signs taken at 0902 BP: 142/82 HR:102 O2: 100%. Administered Benadryl 50mg/mL at 0902 Lot number: 6020111 Exp: 07/21. After administration of Benadryl patient expressed tightness of throat with audible wheezing, immediately administer EPI Pen 0.3 mg/mL Lot number: 0FN1407 Exp: FEB2022 on the left thigh at 0903. Patient improving symptoms. FED FIRE was called at 0901, arrived at 0908, transported at the Hospital at 0912. When: Shot given at 0850, reported symptoms at 0854 Why: Reaction to Pfizer COVID-19 first dose ( Lot number: ER8729 Exp: 07/2021) Patient has history of anaphylaxis reaction.
44 2021-04-15 axillary mass 4/13/21 Started to become fatigued by 5pm on date of vaccine..by 8 pm I was in extreme pain, all my... Read more
4/13/21 Started to become fatigued by 5pm on date of vaccine..by 8 pm I was in extreme pain, all my joints hurt, by 2 am developed a very large lump underneath my left armpit. I?m assuming it?s my lymph nodes..I was unable to lift my arm until 4/16/21.. Pain subsided on 4/15-4/16..With lingering fatigue. 4/16..lump underneath armpit is still there and tender to touch.
44 2021-04-15 oral herpes Several cold sores. Bottom lip blistered almost completely across, swollen and painful. Top lip has ... Read more
Several cold sores. Bottom lip blistered almost completely across, swollen and painful. Top lip has small tiny, painless blisters.
44 2021-04-16 lymph node swelling Sore arm. Swollen lymph node in right underarm with pain
44 2021-04-16 lymph node swelling The lymph node in my left armpit swelled up and hurt quite a bit for about 24 hours. Other than that... Read more
The lymph node in my left armpit swelled up and hurt quite a bit for about 24 hours. Other than that mild fatigue.
44 2021-04-16 swelling Redness, swelling, and itching
44 2021-04-17 anaphylactic reaction Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; It... Read more
Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; This is a spontaneous report from a contactable consumer (reporting for herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 20Mar2021 (Batch/Lot Number: Ep-7534) as single dose for COVID-19 immunization. Medical history included seasonal allergy, asthma, and known allergies: penicillin. Concomitant medication included fexofenadine hydrochloride (ALLEGRA); montelukast sodium (SINGULAIR); amlodipine. all taken for an unspecified indication, start and stop date were not reported. The patient previously took grastek for immunomodulatory therapy and experienced drug allergy; bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En-6198) on 27Feb2021 for COVID-19 immunization. On unspecified date the patient experienced itching all over, coughing, asthma, anaphylaxis. The patient received 2 doses of epinephrine, 100 ml benedryl, and h1h2 bloc. The outcome of the events was recovering. The patient was not tested post vaccination and did not has COVID prior to vaccination.
44 2021-04-17 lymph node swelling Armpit swollen up
44 2021-04-18 peripheral swelling Starting the evening of vaccination dose #2, experienced severe joint pain all over, red/swollen kne... Read more
Starting the evening of vaccination dose #2, experienced severe joint pain all over, red/swollen knees, feet, and hands as well as altered mental status. Mental status improved on post-vaccine day 4. Joint pain and swelling persisted. Presented to rheumatologist 2/1/2021 for evaluation as symptoms were not improving. "She has some synovitis on exam and endorses increased joint pain, swelling, and morning stiffness. At this time will treat with a steroid taper to see if symptoms can get under control. If symptoms persist will need to consider restarting DMARD therapy. Prednisone 15 mg daily for 7 days, then 10 mg daily for 14 days, then 5 mg daily for 14 days. Then off. " Did not tolerate adverse effects of prednisone and taper changed on 2/10/2021 to 10 mg for 5 days and then 5 mg for 5 days and then off. Joint pain continues.
44 2021-04-19 axillary mass, lymph node swelling I developed a lump in my left axilla that I noticed on 2/8 (about 2 weeks) after my second COVID-19 ... Read more
I developed a lump in my left axilla that I noticed on 2/8 (about 2 weeks) after my second COVID-19 vaccination. This lump has persisted and grown slightly larger since then. It is now 4/20 (3 months after my second vaccination).
44 2021-04-19 peripheral swelling mild symptoms of COVID toes after first vaccine, but much worse and still enduring after second vacc... Read more
mild symptoms of COVID toes after first vaccine, but much worse and still enduring after second vaccine. Blue toes, tender toes, sx of pain, swelling and pins and needles consistent with peripheral neuropathy.
44 2021-04-20 peripheral swelling I started having right leg swelling. I noticed a small red spot on my medial side of my knee. I had ... Read more
I started having right leg swelling. I noticed a small red spot on my medial side of my knee. I had this for about a week and then the swelling went down. A few days later, I had redness, skin was warm to touch, and hardness developing where the red spot was. I went to urgent care and the NP sent me to the ER for a possible blood clot. I had a venous study done in the ER and it was determined I had a superficial blood clot and was started on ASA 325 mg daily x7 days. I followed up with a vascular doctor and it was determined the clot was worse and had clotted all the way up the vein into my thigh. It remains superficial in nature at this time. I was started on Xarelto 10 mg daily x1 month. I follow up with vascular in 1 month to make sure the clot is dissolving. I was instructed to Follow up with either the doc or go to the ER with worsening symptoms.
44 2021-04-20 swelling Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Int... Read more
Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Intense headache, neck, facial and cranial pain; Extreme vertigo within 1 hour; loose stool; Nausea; vomiting; Swollen; itchy hives; itchy hives; Swollen left eye; This is a spontaneous report from a contactable HCP and a consumer (the patient). A 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 (Batch/Lot Number: EW0150) as single dose for covid-19 immunisation . Medical history included migraine, demyelination , post-traumatic stress disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced immediate left side (injection side) headache. on 03Apr2021 11:45 with outcome of not recovered , intense headache, neck, facial and cranial pain on 03Apr2021 11:45 with outcome of not recovered , extreme vertigo within 1 hour on 03Apr2021 11:45 with outcome of not recovered , loose stool on 03Apr2021 11:45 with outcome of not recovered , nausea on 03Apr2021 11:45 with outcome of not recovered , vomiting on 03Apr2021 11:45 with outcome of not recovered , swollen on 03Apr2021 11:45 with outcome of not recovered , itchy hives on 03Apr2021 11:45 with outcome of not recovered , swollen left eye on 03Apr2021 11:45 with outcome of not recovered. All the reported events were considered Important Medical Events. Course of the event: Immediate left side (injection side) headache. Spread to entire head within 30 minutes. Intense headache, neck, facial and cranial pain persists at hour 53. Extreme vertigo within 1 hour, persisting now at hour 53. Nausea, vomiting and loose stool within 6 hours. Vomiting ceased at 48 hours post 1st shot vaccination. Nausea and diarrhea persists at hour 53. Swollen, itchy hives, injection side within 40 hours, spread to neck and face. Swollen left eye, within 24 hours, waning at hour 53. No follow-up attempts are needed. No further information is expected.
44 2021-04-21 lymph node swelling Severe joint pain-elbows, shoulders, knees, hips, and wrist. 24 hours Swollen lymph nodes in neck ... Read more
Severe joint pain-elbows, shoulders, knees, hips, and wrist. 24 hours Swollen lymph nodes in neck and left armpit-over 48 hours--still persisting 2 days later
44 2021-04-22 anaphylactic reaction, swelling face Patient received first dose of Pfizer COVID-19 vaccine on 1/21 at 1011. She presented to the ED that... Read more
Patient received first dose of Pfizer COVID-19 vaccine on 1/21 at 1011. She presented to the ED that evening around 2100 due to concerns for allergic reaction. Pt reports the reaction started around 1930 after eating and consisted of nausea, throat tingling, facial swelling and chest tightness/SOB. Oral diphenhydramine was self-administered. In the ED, she was given IM epinephrine and IV methylprednisolone with good response. Was discharged home about 2 hours later with prescription for epinephrine autoinjectors. Pt reports no new foods were consumed that day therefore, reaction likely vaccine related. Pt advised NOT to receive second dose.
44 2021-04-22 lymph node swelling WITH HER 1ST VACCINE SHE SAID HER LYMPH NODES WERE SWOLLEN. TODAY SHE SAID SHE WAS HAVING AN ALLERGI... Read more
WITH HER 1ST VACCINE SHE SAID HER LYMPH NODES WERE SWOLLEN. TODAY SHE SAID SHE WAS HAVING AN ALLERGIC REACTION AND ON SITE EMS RESPONDED. VITALS BELOW. NO SIGNS OF ALLERGIC REACTION, BUT HER LYMPH NODES WERE SWOLLEN. DIPHENHYDRAMINE WAS GIVEN TO BE ON THE SAFE SIDE. SHE WAS RELEASED TO HOME.
44 2021-04-23 lymph node swelling, peripheral swelling Swollen arm and swollen lymph notes / armpit in left arm Pain in arm and armpit
44 2021-04-24 swelling, lymph node swelling, peripheral swelling, swelling face Swollen lymph nodes in front and back of neck and by collarbone, puffy face/eyes and neck. Mouth/ton... Read more
Swollen lymph nodes in front and back of neck and by collarbone, puffy face/eyes and neck. Mouth/tongue feels swollen, but no trouble breathing. Itchy neck and face. Puffy hands, feet, and lower legs. Headache.
44 2021-04-25 lymph node inflammation, lymph node swelling Fever, chills, swollen lymph nodes in neck and shoulder on injection side.
44 2021-04-25 lymph node swelling severe hot and cold chills a few hours after the vaccine then flu like symptoms, high temperature so... Read more
severe hot and cold chills a few hours after the vaccine then flu like symptoms, high temperature sometimes reaching 104, sore body, hot and cold, burning skin, hardly able to move swollen lymph nodes under armpit on same side as vaccine (left) metallic taste in mouth day 2,3,4
44 2021-04-25 oral herpes 4/22/2021 PATIENT NOTICED LIPS WERE DRY, RED, AND PEELING 4/23/2021 PATIENT LIPS STARTED ITCHING AND... Read more
4/22/2021 PATIENT NOTICED LIPS WERE DRY, RED, AND PEELING 4/23/2021 PATIENT LIPS STARTED ITCHING AND BUMPS DEVELPED IN THE CORNERS OF HER MOUTH 4/24/2021 LIPS GETTING WORSE WITH BUMPS, TICHING, AND REDDNESS. STARTED TAKING ABREVA FOR CORNER BUMPS 4/25/2021 LIPS GETTING PUFFY, SORE, TINGLY, AND MORE BUMPS NOTED 4/26/2021 LIPS VERY SWOLLEN, UPPER WORSE THAN LOWER. OUTER RIM OF LIPS VERY RED. BUMPS NOTED AS HIGH AS HALFWAY BETWEEN NOSTRILS AND UPPER LIP LOOKING BACK ON START OF PFIZER COVID VACCINE SERIES (3/30/2021) PATIENT ALSO REPORTS ECZEMA GOT WORSE ESPECIALLY ON TOP OF HANDS. HAS ITCHINESS ALL OVER BODY SINCE MID APRIL. LASTLY, AFTER DOSE 1 SHE DEVELOPED A COLD SORE 3 DAYS AFTER DOSE 1 AND STARTED GENERIC VALTREX. COLD SORE RESOLVED A FEW DAYS LATER. SHE HAS STARTED BENADRYL ON A NIGHTLY BASIS AND RESTARTED GENERIC VALTREX ON 4/26/2021. SHE ALSO HAS BEEN APPLYING LAVENDER AND PEPPERMINT LIP BALM THAT SHE MAKES HERSELF (AND HAS USED FOR A LONG TIME), CURELL LOTION, ANTI-ITCH CREAM, AND ICE PACKS. NOTHING SEEMS TO BE PROVIDING MUCH RELIEF AT THIS POINT.
44 2021-04-26 lymph node swelling Left underarm lymph node swollen (shot arm) for about 1 week
44 2021-04-26 lymph node swelling The day after the vaccine I was in a lot of pain. It started overnight my Lymph nodes were very swol... Read more
The day after the vaccine I was in a lot of pain. It started overnight my Lymph nodes were very swollen and my neck was stiff. As the day went on I started to get more bumps on my head and other places. The bumps were severely painful and I could barely move my head without flinching. I went to the ER and the doctor said it was a normal reaction with my Lymph Nodes. I actually had the Shingles and had to return to the ER again. The second time at the the ER it was identified immediately. The rash was mostly on my head with a few on my torso which cleared up sooner. It has been 31 days and I still have episodes of severe pain once or or twice daily and don't last as long. The pain is a level 10 when it is severe. It is at a level five when it is not spiking. I have not had any problems with my pregnancy so far and I am twenty eight weeks. Due Date 07/17/2021 Pregnancy-second pregnancy
44 2021-04-26 lymph node swelling Swollen lymph noses in left under arm Tingling in throat
44 2021-04-26 peripheral swelling Headache, shortness of breath, swelling of legs, dizziness, drowsiness, joint pains, discomfort in t... Read more
Headache, shortness of breath, swelling of legs, dizziness, drowsiness, joint pains, discomfort in the chest
44 2021-04-26 peripheral swelling Fever 99.8 from the night got the vaccine through next morning. Taking ibuprofen reduced the fever. ... Read more
Fever 99.8 from the night got the vaccine through next morning. Taking ibuprofen reduced the fever. Arm sore after fever, got red and swelling and haven?t gone after 4days now
44 2021-04-26 swelling face, peripheral swelling swelling to feet, body aches, chills, sinus congestion, facial/lip swelling, patient describes throa... Read more
swelling to feet, body aches, chills, sinus congestion, facial/lip swelling, patient describes throat as feeling like it is closing, cough, SOB, fatigue , mucous in stool, chest pain.
44 2021-04-27 bursitis Bursitis in right shoulder and Right elbow
44 2021-04-27 lymph node pain, lymph node swelling Swollen lymph node in neck on the same side of the injection. After first vaccine the reaction oc... Read more
Swollen lymph node in neck on the same side of the injection. After first vaccine the reaction occurred about a week later and took about two weeks for the swelling to decrease. After the second vaccine, the swelling occurred under 24 hours later. The nodule is swollen and painful.
44 2021-04-27 lymph node swelling, lymph node pain Swollen and painful lymph nodes and left under arm
44 2021-04-27 lymph node swelling 1/28/2021-swollen lymph nodes and pain to left side of chest and injection site. This pain continued... Read more
1/28/2021-swollen lymph nodes and pain to left side of chest and injection site. This pain continued and I went to Dr. on 4/06/2021. Dr. treated me with Toradol and Tylenol#3. Schedule me to have a mammogram and ultrasound on 4/20/2021. This is when it was discovered I had a clot in left arm. Currently being treated with blood thinners(Eliquis).
44 2021-04-27 lymph node swelling Extremely swollen armpit lymph node, very tender. Tiredness, body muscle aches, headache
44 2021-04-27 swelling face I had Bell?s palsy type symptoms within 45 minutes one eyebrow raised higher than the other. My face... Read more
I had Bell?s palsy type symptoms within 45 minutes one eyebrow raised higher than the other. My face felt numb, tingled. Towards the evening my face was flush red, I looked like I had a chemical peel and it was streaking. Facial swelling. My hands looked like they were very read on the palms.
44 2021-04-27 swelling Has had swelling and redness over site that developed within 24 hours and in past 1-2 weeks has star... Read more
Has had swelling and redness over site that developed within 24 hours and in past 1-2 weeks has started having diffuse hives down L arm and other extremities
44 2021-04-28 swelling Patient received Pfizer COVID vaccine- lot number and dose number not documented. Reaction: Angioe... Read more
Patient received Pfizer COVID vaccine- lot number and dose number not documented. Reaction: Angioedema, Rash, Stevens Johnson Syndrome Severity: High
44 2021-04-28 swelling face clammy, swollen left cheek, difficulty swallowing, upper arm (site of injection) had no feeling
44 2021-04-29 swelling Patient had hives, angioedema and urticaria
44 2021-04-29 lymph node swelling On 4/29/21 patient called to inform me that she was having a "swollen armpit" in her COVID19 vaccine... Read more
On 4/29/21 patient called to inform me that she was having a "swollen armpit" in her COVID19 vaccine arm. I explained it was probably due to her lymph node in that arm working extra hard. We discussed taking ibuprofen and marking how swollen it is now and to see her PCP if the swelling gets any worse. Her vaccine occurred on 04/27/2021
44 2021-04-29 lymph node swelling Dizziness one hour after second vaccine on the next day sore arm at side of vaccine and drowsiness t... Read more
Dizziness one hour after second vaccine on the next day sore arm at side of vaccine and drowsiness tiredness. On Monday afternoon noticed lymph node in front of right ear opposite side of vaccine was swollen on Tuesday notice that there was fluid swelling directly under my right knee went to the doctor they said to monitor symptoms Thursday woke up to swelling in face on the left side between nose and cheek. Today feeling tinglingness in both legs hands and swelling continues in face right lymph node in front of ear is not as large.
44 2021-04-29 swelling Patient had localized swelling reaction from vaccine in Left arm, 30mm, redness at site, no pain, no... Read more
Patient had localized swelling reaction from vaccine in Left arm, 30mm, redness at site, no pain, no itching and no burning noted at site of injection. No other symptoms noted. No other signs or symptoms, 15mm induration.
44 2021-04-30 fluid retention First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: ... Read more
First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; This is a spontaneous report from a 44-year-old female consumer (patient). A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in left arm on 07Apr2021 11:30 (Batch/Lot Number: EW0151) as single dose for COVID-19 immunization. Medical history included asthma and allergies multiples (all antibiotics) from an unknown date and unknown if ongoing. Concomitant medications included vitamins and collagen received within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced first 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. after: abdominal pain, malaise, nausea, eye puffiness, water retention on 07Apr2021 12:00. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse event. Outcome of the events was not recovered. The events were assessed as non-serious. No follow-up attempts are needed. Information on the lot/batch number cannot be obtained.
44 2021-04-30 lymph node pain 1) small headache day after shot 2) pain in lymph node that started about 7 days after shot - pain c... Read more
1) small headache day after shot 2) pain in lymph node that started about 7 days after shot - pain continues 3 weeks after shot. Exam at doctor noted no issues 3) unable to taste bitter tastes which started about 7 days after shot 4) periodic metallic taste in mouth 3-4 times within three weeks after shot.
44 2021-04-30 swelling face face swelled; lip tingling; throat was itchy; feverish knot like a lump; This is a spontaneous repor... Read more
face swelled; lip tingling; throat was itchy; feverish knot like a lump; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received 1st dose of BNT162B2 (Pfizer vaccine for COVID 19, Lot# EW0151) on 03Apr2021 13:50 pm on left arm for civid-19 immunization. Patient History was ongoing mast cell activation syndrome. She states she has had this condition from birth. Ongoing Ehlers-Danlos syndrome. She said she was just diagnosed with this condition 6 weeks before but it is a condition that is present from birth, that it is one of those zebra diseases. Ongoing POTS. She states she has had this condition for quite while; for 10 years or more. She says she does not know what kind of stuff we are looking for she has a list of precious medical conditions. She says her family has a history of high blood pressure diabetes, and that is probably the only two relevant. She says most of them have high blood pressure, her parents her grandparents her grandfather had diabetes, her dad had high blood pressure, her mom had high blood pressure. Concomitant Products included cetirizine hydrochloride (ZYRTEC ALLERGY) Ongoing (She states she has been on this medication for about a month mast cell activation syndrome), cimetidine (TAGAMENT) Ongoing (She states she has been on this medication for about a month. States they work together for mast cell activation syndrome), duloxetine hydrochloride (CYMBALTA) Ongoing (She started this medication about a month and a half ago to help with chronic pain due to Ehlers-Danlos syndrome). The caller says she got the Pfizer vaccine on 03Apr2021 the first one and had reaction where her face swelled, her lip was a little tingly and her throat was itchy. She says the pharmacist gave her 100mg of Benadryl and that stopped it. She says it has been 2 weeks almost since she got the vaccine and she still had a feverish knot like a lump. She states that she has mast cell activation syndrome and she has heard that the second dose is rougher on the body. She says she is seeking guidance, should get the second vaccine because normally the reaction is worse for the second one since she had a face and lip and throat reaction with first dose. She says she does not have a primary physician now that she lives in(Withheld) she has not had a chance to get a primary care provider. She says she had been taking 100mg Benadryl but does not have bottle available at this time. She says he is taking it every 6 hours. NDC lot number expiration date dosage amount not provided due to caller does not have the bottle with her. No Emergency Room, no Physician Office visit. Outcome of the event for feverish knot like a lump was not recovered, for other events were recovered on 05Apr2021. No follow-up attempts are needed. No further information is expected.
44 2021-05-01 lymph node pain, lymph node swelling Swollen lympnode left axillary Taking tylenol and ibuprofen for pain relief
44 2021-05-02 swelling, anaphylactic reaction Pt presented to ER 1 hour after receipt of 2nd Pfizer vaccine, presenting with angioedema/anaphylaxi... Read more
Pt presented to ER 1 hour after receipt of 2nd Pfizer vaccine, presenting with angioedema/anaphylaxis, In ER received epi, racemic epi, solumedrol, mamotidine, benadryl, then intubated and moved to ICU. Was hemodynamically stable, unremarkable airway pressures.
44 2021-05-02 lymph node swelling LARGE RED INJECTION SITE THAT HAS GOTTEN LARGER AND MORE PAINFUL LASTING 4 DAYS SO FAR! SEVERE HEADA... Read more
LARGE RED INJECTION SITE THAT HAS GOTTEN LARGER AND MORE PAINFUL LASTING 4 DAYS SO FAR! SEVERE HEADACHES AND FATIGUE LASTING 4 DAYS SO FAR! SWOLLEN LYMPH NODES UNDER LEFT ARM! VERY ITCHY INJECTION SITE! LARGE KNOT IN THE RED AREA OF INJECTION SITE THAT HAS GOTTEN LARGER SINCE INJECTION LASTING 4 DAYS SO FAR!!
44 2021-05-02 peripheral swelling Two days after the 2nd dose of the vaccine I started breaking out in hives on my right arm. Later t... Read more
Two days after the 2nd dose of the vaccine I started breaking out in hives on my right arm. Later that night it had spread to my right arm and parts of my legs. When I woke up Saturday it had spread further to the front and back of my thighs . By Saturday night both of my feet were swollen along with my hands. By Sunday morning it was all over my back my neck and face and my eyelids were swollen. It was then that I went to the ER at the Hospital. My vaccination was done in sporting event stadium.
44 2021-05-02 peripheral swelling Left underarm and upper chest swelling. Left breast pain.
44 2021-05-03 lymph node pain, swelling, lymph node swelling Extremely painful swelling in left armpit lymph node. The swelling then moved into my neck/collar bo... Read more
Extremely painful swelling in left armpit lymph node. The swelling then moved into my neck/collar bone area as the selling in my armpit eased. I was unable to wear a bra for 2 and 1/2 days because it was so painful. I am on day 4 post injection and the swelling in the armpit is almost gone but I still have some swelling in my neck.
44 2021-05-03 peripheral swelling Dizzy, black dots in vision, weak, nausea, all black vision, very dizzy - they took me and laid me d... Read more
Dizzy, black dots in vision, weak, nausea, all black vision, very dizzy - they took me and laid me down with ice on the back of my neck and I felt better. All day felt weak and woozy and brain fog. Lethargic and spacey the following two days. Three days after the shot, I had a pain in my hand and a blood vessel started popping out and hurting. It was quite painful for that evening and night and after ice and rest and ibuprofen, swelling was down the next morning and it's still just a little tender to the touch.
44 2021-05-04 anaphylactic reaction Morning of April 03, 2021 I woke up with swollen, itchy, burning eyes and pain in hands. I took an A... Read more
Morning of April 03, 2021 I woke up with swollen, itchy, burning eyes and pain in hands. I took an Allegra and went to the vaccination center. The Head nurse sent me to the Urgent care. During the exam I developed tightness in chest and throat started to swell. Doctor determined it was a delayed analphylactic reaction to the COVID vaccine. It was delayed due to taking the Allegra the previous day. He treated me with a benedryl shot and famotidine and prednisone in pill form. Observed for 1 hour and allowed to go home. As of April 5, 2021, still experiencing tightness in chest. Swelling in face has reduced
44 2021-05-04 swelling face Rash and hives on face; Rash and hives on face; throat itchiness; swollen face around eyes; This is ... Read more
Rash and hives on face; Rash and hives on face; throat itchiness; swollen face around eyes; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number EL9262, expiry date: unknown) via an unspecified route of administration in left arm on 15Feb2021 at 09:15 (at the age of 44-year-old) as a single dose for Covid-19 immunization in Hospital. The patient had known allergies: sulfa, penicillin, latex. The patient did not had any other medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications (in two weeks) included melatonin, magnesium, cetirizine hydrochloride (ZYRTEC), and azelastine hydrochloride, fluticasone propionate (DYMISTA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number EL9262, expiry date: unknown) via an unspecified route of administration in left arm on 25Jan2021 at 08:15 as a single dose for Covid-19 immunization. On 20Feb2021 at 7:30, the patient experienced rash and hives on face, throat itchiness, and swollen face around eyes. Patient received treatment with Oratidine, Benadryl, and Prednisone for the events. The outcome of the events of rash and hives on face, throat itchiness, and swollen face around eyes was recovering. No follow-up attempts are possible. No further information is expected.
44 2021-05-05 lymph node swelling, lymph node pain 5 hours post injection - extreme fatigue; 7 hours post injection - diarrhea; 12 hours post injection... Read more
5 hours post injection - extreme fatigue; 7 hours post injection - diarrhea; 12 hours post injection - extreme body aches, chills, headache, and swollen/painful lymph node on underarm of injection site; 12 - 48 hours post injection - fatigue, body aches, and headache continued; 55 hours post injection - consistent itching sensation on lower extremities (all over legs, would not stop, had to apply cortisone cream all over both legs). I had no side effects with first injection. It's been 5 days since I received the second injection. During that time, the diarrhea and headaches have been off and on. Headache does not go away with Tylenol. I do also suffer from migraine headaches and have had to take 4 abortive migraine pills to keep the headaches manageable since receiving the injection. All of the side effects I experienced, are (from what I have read), common with the second vaccine with the exception of the itchy legs. I did not have any rash or hives develop on my legs, but they were itching so badly it was keeping me from being able to go to bed and fall asleep. I do not have allergies.
44 2021-05-05 lymph node swelling Swollen lymph nodes in left armpit Muscle pressure and pain
44 2021-05-05 lymphatic obstruction My lymphedema has largely been in remission. Occasionally I have symptoms for which I wear my sleeve... Read more
My lymphedema has largely been in remission. Occasionally I have symptoms for which I wear my sleeve and glove for a few hours. Following my second dose of the CV19 vaccine, my symptoms became extreme. I woke up at 3 a.m. with throbbing in my arms and armpits. I also experienced flu like symptoms for about a day.
44 2021-05-05 oral herpes Cold sore . Very aggressive. Course was about 7 days. Then Felt first stages of recurrence of an... Read more
Cold sore . Very aggressive. Course was about 7 days. Then Felt first stages of recurrence of another cold sore 10 days after second shot. Have over the counter medicine on hand so seemed to stop it. However, I only get cold sores less than once a year so timing suggests a connection.
44 2021-05-06 lymph node swelling Swollen lymph nodes around collarbone
44 2021-05-06 peripheral swelling I developed pain in my left arm and shoulder on 4/25. By 4/26, my arm had broken out in a spotted r... Read more
I developed pain in my left arm and shoulder on 4/25. By 4/26, my arm had broken out in a spotted red rash with clear blisters that extended into my hand. The pain was unbearable. Radiating from the top of my arm out through my fingers. My hand swelled up and I developed severe blistering on my left hand and my fingers became pins and needles numb. I could not use my arm for over a week. The rash and burning pain in my arm and hand felt like shingles. Upon my own research and speaking with the first doctor, it looked like shingles. It is now 5/7. The rash has scabbed over on my arm, but I am still in pain and the blisters remain on my hand. They are getting better, but still very severe. The pain and numbness in the tips of my fingers remains. It is hard to work or type with my left hand.
44 2021-05-06 swelling "On the drive home from work after getting vaccinated I started feeling hot and swelling up, probabl... Read more
"On the drive home from work after getting vaccinated I started feeling hot and swelling up, probably within 20 minutes of getting the vaccine. I didn't need to use my EpiPen but the hives started later that day and continued to get worse over the next few days so I went to my provider and was started on prednisone on 5/5. My symptoms have started improving (5/7).
44 2021-05-06 swelling Patient received first Pfizer COVID-19 vaccination at vaccination Center on 5/5. She began to feel n... Read more
Patient received first Pfizer COVID-19 vaccination at vaccination Center on 5/5. She began to feel nausea, stomach discomfort, lightheaded, have sensation of throat swelling, and felt short of breath as well. Staff attended to her; she was given 2 doses of epinephrine and 25 mg IM Benadryl at the convention center. Then EMS gave patient 10 mg IV dexamethasone en route. Upon arrival at the Emergency Room, patient had significant improvement in her symptoms though tongue still felt large, normal phonation, clear lungs, normal BP and HR. Patient has history of anaphylaxis with other medications and honey bee venom. She has previously been hospitalized for 1-2 days due to the severity of her allergic reactions. No history of asthma or any features of bronchospasm. Patient remained stable after 2 hours of observation. She was provided a prescription for an epinephrine pen and discharged home. If the PCP for this patient is not able to provide additional details (ED provider) may also be able to provide additional details.
44 2021-05-08 lymph node swelling Pfizer-BioNTech COVID-19 Vaccine EUA - Fever, swollen lymph nodes on left armpit
44 2021-05-08 peripheral swelling Redness around the shot area The night of the shot, lip started to itchy during dinner After that, ... Read more
Redness around the shot area The night of the shot, lip started to itchy during dinner After that, hives on the edge of the lips showed up and itchy. 4 days later of the shot (5/3), rashes showed up on the right cheek and right side of the neck. On the following day (5/4), I woke up with swollen lips and the rash showed all over the face and neck. On 5/6, the rash spread down to the upper chest area. Went to the doctor and got steroid medication. On 5/7, an acne looking bumps showed up on the both palms. As of today, I still have hives all over my face and neck and palms. Lips are rough and dry and skins starts to peel off both on lips and face.
44 2021-05-08 swelling Severe inflammatory reaction - swelling throughout entire body, (Most visibly noticeable in hands),... Read more
Severe inflammatory reaction - swelling throughout entire body, (Most visibly noticeable in hands), severe neck and back pain, Face and upper chest became very red, band-Aid from vaccine uncharacteristically for a patient left severe redness persistent after more than 24 hours from 2nd shot.
44 2021-05-10 lymph node swelling, lymph node pain Symptom #1 - starting the second night after the second shot after going to bed, my lymph nodes (aux... Read more
Symptom #1 - starting the second night after the second shot after going to bed, my lymph nodes (auxiliary) in my left arm same as the shot became extremely tender and swollen and remainder swollen for 5 days. The swelling reduced but the tenderness remained although it continues to improve. Currently on day 8. Symptom # 2 - starting somewhere in the first week, I believe Thursday night, I thought I had a bug bite on my back as I felt an itch, over the next couple days this got worse, when I went into the on Monday I was diagnosed with shingles rash and have begun treatment with
44 2021-05-10 lymph node swelling pregnant at the time of vaccination; Swollen lymph nodes/ painful swollen lumps; Shingles/ pustules ... Read more
pregnant at the time of vaccination; Swollen lymph nodes/ painful swollen lumps; Shingles/ pustules on my head and neck; The pain progressed over the course of a week before it became unbearable; prevented her from daily activities including work; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8737) via an unspecified route of administration, administered on the left arm on 29Mar2021 19:00 as 1st dose, single for COVID-19 immunization. Medical history included dermatomyositis, antisynthetase syndrome and Sjogrens syndrome. Concomitant medications included metformin; insulin glargine (BASAGLAR); hydroxychloroquine and levothyroxine sodium (LEVOTHYROX). The patient previously took azathioprine and experienced allergy. Patient was pregnant at the time of vaccination. Within hours, patient developed painful swollen lumps and pustules on my head and neck, later diagnosed as swollen lymph nodes and shingles on 30Mar2021 04:00. The pain progressed over the course of a week before it became unbearable and patient was treated at ED and given antiviral for shingles. She is on DAY 16 and the pain from the swollen lymph nodes still prevented her from daily activities including work. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Treatment received for the events in the ED included morphine drip and acyclovir RX. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19: Nasal Swab test: negative on 06Apr2021. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The mother reported she became pregnant while taking bnt162b2. The mother was 24 Weeks pregnant at the onset of the event. The mother was due to deliver on 17Jul2021. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
44 2021-05-10 peripheral swelling Same evening immunization felt hives and wheezing (4/15) which lasted through 4/17. Then on 4/18 st... Read more
Same evening immunization felt hives and wheezing (4/15) which lasted through 4/17. Then on 4/18 started to notice pain and swelling in volar surface of the ipsilateral forearm - unclear at time if it was related Was then evaluated in the office, noted to have palpable mass in volar aspect of ipsilateral forearm. duplex ultrasound showed possible mass but no clot. Follow-up ultarsound showed possbile AVM and finally MRI showed no etiology to explain the mass. repeat ultrasound described it as vascular) HIT antibody was weak positive (at 0.4) In the interim, multiple d-dimer tests were normal, but one drawn simultaneously was elevated (possible specimen issue), and there was also an transient thrombocytopenia which we understand has completely resolved. Currently, hematology + allergist referrals are pending.
44 2021-05-10 swelling I received the Biontech-Pfizer booster which is the 2nd of 2 doses. My lips felt numb for about 20 ... Read more
I received the Biontech-Pfizer booster which is the 2nd of 2 doses. My lips felt numb for about 20 min while waiting in the waiting area after receiving my 2nd dose on May, 06. 2021. The numbness went away and i could feel my lips again. Swelling of my right shoulder with soreness and swelling under my armpit with some pain began on Friday 05/07/2021 upon waking up at 8:30am. My right shoulder and armpit felt warm to touch and pain strengthen on 05/08/2021. I treated it with ibuprofen. Today 05/11/2021 the swelling is going down and the pain under my arm pit is lessening.
44 2021-05-11 anaphylactic reaction pt received 1st pfizer covid shot at 3:47 pm. she told me she had a history of anaphylaxis to oral b... Read more
pt received 1st pfizer covid shot at 3:47 pm. she told me she had a history of anaphylaxis to oral benadryl and i counseled her that she should wait 30 minutes for observation after the immunization. around 4 pm she notified my technician the outside of her throat was starting to feel hot and itchy. i took her into the room and sat her down in private. I gave her an ice pack to put on her throat and was observing her when the itching started on her abdomen. I advised her she was having an anaphylactic event and she denied me calling ambulance or using epipen. Around 4:05 pm she asked for some cream so we gave her some hydrocortisone cream OTC that she applied to itchy area on chest and throat and she said she was feeling better. Around 4:15 she told me the itching was starting inside her mouth and allowed me to call 911 and administer one dose of epinephrine 0.3 mg in her left thigh. The fire department came around 4:20 and started talking to her and taking vitals. blood pressure was 146/90 and heart rate was 100 even with the epinephrine causing her to shake. They advised she wait for emt's that arrived around 4:30 pm and they conviced her to go in the ambulence to the hospital even though she was feeling fine since there was a chance the epi would wear off and she would need more help.
44 2021-05-11 swelling Angioedema with throat tightness, flushed and near syncope
44 2021-05-11 lymph node pain, lymph node swelling Monday, May 3 developed lymph node on left collar bone, went to ER due to pain on Thurs May 6
44 2021-05-11 oral herpes, lymph node swelling blisters in her mouth; exhausted and winded; exhausted and winded; Metallic taste, hives on face and... Read more
blisters in her mouth; exhausted and winded; exhausted and winded; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; cold sore; super red and itchy; super red and itchy; tongue started to get itchy; the lymph nodes in her neck were really swollen; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0153, first dose, expiration date 31Jul2021) solution for injection intramuscular in the left arm on 16Apr2021 at 15:45 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included acid reflux, latex (allergy), sulfa based medicine (allergy), and pineapple (allergy). Concomitant medications included ongoing lansoprazole (PREVACID) for acid reflux, ongoing montelukast sodium (SINGULAIR) for seasonal allergy, ongoing fluticasone propionate (FLONASE) for seasonal allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 16Apr2021, the patient experienced metallic taste (5 seconds after vaccination), hives on face and neck (45 minutes after), shortness of breath walking resulting on doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care which included treatment with steroid shot and BENADRYL shot. On 17Apr2021, the patient experienced exhausted and winded. In Apr2021, the patient experienced cold sore, was super red and itchy, tongue started to get itchy, the lymph nodes in her neck were really swollen that included unspecified treatment. On 24Apr2021, the patient experienced blisters in her mouth and used hydrogen peroxide 3% to clean. The outcome of the events metallic taste, hives on face and neck, shortness of breath walking was recovering. The outcome of the events cold sore, super red and itchy, exhausted and winded, tongue started to get itchy, the lymph nodes in her neck were really swollen was unknown. The outcome of the event blisters in her mouth was not recovered. Since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.
44 2021-05-12 anaphylactic reaction 20 minuted after getting my second dose I started having an anaphylaxis reaction. My throat became i... Read more
20 minuted after getting my second dose I started having an anaphylaxis reaction. My throat became itchy, sore and started to feel tight. I took 3 doses of benadryl to help calm the symptoms as I did not want to get stuck paying for an emergency room visit or use my EpiPen which would also result in an ER visit. Soon after, I also started feeling extremely itchy all over but mainly at injection site. My body became tingly and I had hot and cold flashes. About an hour after that, the headache, nausea and horrible body aches began. the itching at injection site stopped after 2 hours but the rest of the symptoms remained for 3 days with the exception of the headache, nausea and body aches which still remain and no amount of over the counter medication help.
44 2021-05-12 swelling face four days later I got very tired, sore throat, swollen face, pain on the left side of neck and face ... Read more
four days later I got very tired, sore throat, swollen face, pain on the left side of neck and face (which is already chronic for me, but this was more acute), and nerve pain across my left cheek under the sinus, right side of my face drooping (bells palsy)
44 2021-05-12 swelling May 7, 2021, approximately 9 hours after receiving the vaccine, I experienced nausea, vomited and di... Read more
May 7, 2021, approximately 9 hours after receiving the vaccine, I experienced nausea, vomited and diarrhea. After 13 hours after receiving the second dose of the vaccine, my leg muscles began to contract uncontrollably, which caused severe pain. The contractions did not stop for two hours, after taking three Aleve tablets. This was followed by extreme fatigue for an additional 24-hour period alongside bruising down my legs and signs of popped blood vessels. An additional symptom that I continue to experience is massive swelling and pain in my breasts – this has lasted for three days. I was sent to the ER to determine if I had a blood clot in my leg.
44 2021-05-13 swollen extremities Swelling in the area of ??the vaccine, then swelling in the armpit in a ball shape and it is still a... Read more
Swelling in the area of ??the vaccine, then swelling in the armpit in a ball shape and it is still a little swollen and with a little pain.
44 2021-05-13 swelling face Following the first dose of the Pfizer vaccine, the patient reported to our medical tent with compla... Read more
Following the first dose of the Pfizer vaccine, the patient reported to our medical tent with complaints of nausea and stomach discomfort. During assessment, she developed new complaints of throat itching, tongue and facial swelling, and voice changes. The provider onsite administered diphenhydramine 25mg IM at 1340, epi 0.3mg IM at 1343 with some resolution of symptoms. Patient reported symptoms again at 1348 so an additional epi 0.3mg IM and diphenhydramine 25mg IM given. EMS onsite at 1350 and patient was transported to local emergency room. ED room notes describe the following: BP=123/84, HR=75, Temp=36.8, RR=19, O2Sat=98%, EKG normal, Troponin <0.02. Notes are limited. Patient reported ongoing throat swelling. RN noted that oral cavity visualized with no swelling observed. HR up to 125 with patient complaints of heart 'racing,' reassurance provided. Patient discharged to home following several hours of observation and a primary diagnosis of 'allergic reaction.'
44 2021-05-14 anaphylactic reaction blacked out; delayed anaphylactic reaction; Tongue Swelled; Couldn't swallow; Couldn't breathe right... Read more
blacked out; delayed anaphylactic reaction; Tongue Swelled; Couldn't swallow; Couldn't breathe right; Head felt weird; Felt Cold; lightheaded; This is a spontaneous report from a contactable consumer reporting for herself. A 44-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 22Apr2021 at 11:30 (Batch/Lot Number: EW0171) as a single dose for COVID-19 immunization. There were no additional vaccines administered on the same date and no vaccination administered in the 4 weeks prior. Medical history included ongoing Hashimoto's Thyroid (diagnosed with this condition many, many years ago). There was no relevant family history. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 01Apr2021, Lot Number: ER8737; in right arm. On 22Apr2021, about a half hour after the shot she states her head felt weird, she couldn't swallow, she felt cold, and she could not breathe right. On 23Apr2021, she was driving her husband and blacked out. Her tongue also began to swell. She just happened to be by the exit ramp to the hospital. She visited the Emergency Room. They told her she was having a delayed anaphylactic reaction. No relevant tests were performed according to the reporter. All of her symptoms recovered when she started prednisone on 23Apr2021. She was prescribed prednisone, taper dose with last dose 27Apr2021. She still remained with lightheadedness and still could not drive. The only one persisting was the weird feeling in her head, almost like a lightheaded feeling. She could not drive due to this symptom There was no physician office visit for the events. The events delayed anaphylactic reaction, blacked out, tongue swelled, couldn't swallow, couldn't breathe right, and feeling cold were resolved on 23Apr2021. The lightheadedness and head felt weird were ongoing (not recovered).
44 2021-05-15 swelling Swelling and redness, in face and neck, hands/wrists, feet - Mild (but severe enough to be noticeabl... Read more
Swelling and redness, in face and neck, hands/wrists, feet - Mild (but severe enough to be noticeable to others); 1st dose occurred 2-3 hours later, was mostly gone by next morning; 2nd does occurred in about 30 minutes; even more mild, but still noticeable, Zyrtec allergy pill lessened it to very mild swelling Swelling in mouth (left lower lip and left side of tongue) only at 2nd dose; the Zyrtec did help, but it did not go away Slight tingling in hands, mostly fingertips - 2nd dose only; mild Extreme fatigue, headache, nausea - 1st dose only, lasted two days
44 2021-05-18 pancreatitis discomfort pain at the injection site; can't eat; Nerve pain; arm pain; Abdominal pain; feelings of ... Read more
discomfort pain at the injection site; can't eat; Nerve pain; arm pain; Abdominal pain; feelings of fullness; Food intolerance; Heartburn; Indigestion; Pancreatitis/my auto immune flares as pancreatitis; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 (Batch/Lot Number: ER8731) at the age of 44 years, as single dose for covid-19 immunisation. Medical history included systemic lupus erythematosus from 1994 and ongoing, hypothyroidism from an unknown date and unknown if ongoing, Addison's disease from an unknown date and unknown if ongoing , autoimmune pancreatitis from 2015 and ongoing. The patient's concomitant medications were not reported. The patient experienced pancreatitis/my auto immune flares as pancreatitis on 24Apr2021 after 10 days from vaccination. On an unspecified date the patient experienced discomfort pain at the injection site, can't eat, nerve pain, arm pain, abdominal pain, feelings of fullness, food intolerance, heartburn, indigestion. The patient didn't think her immune response will be as strong. She has lupus, her auto immune flares as pancreatitis. This is one of the most significant flares that she has experienced. The flare is very significant and she is suffering. This is a direct result from the vaccine. Even though she has lupus she is in exceptional health. Her physicians consulted came to the consensus that it getting the vaccine benefit outweighs the risk and chose the pfizer covid vaccine. They knew she may experience a flare, wasn't something uncommon, there was knowledge a flare may happen but nothing so intense. She can't eat. She can only have water and medication. She is going to see what blood results are in. The patient underwent lab tests and procedures which included blood test: unknown results on unknown date. The outcome of the events was unknown.
44 2021-05-18 swelling pt says her she has swelling in the crease of her left elbow, her bicep and her arm pit. When she h... Read more
pt says her she has swelling in the crease of her left elbow, her bicep and her arm pit. When she holds her arm up it causes her pain but does not have any pain at the injection site. Pt will see her PCP for her symptoms when she can get in to him.
44 2021-05-19 lymph node swelling Right as injection was going in I felt a rush of something up my arm, side of my neck and into my ea... Read more
Right as injection was going in I felt a rush of something up my arm, side of my neck and into my ear. Waited 15 minutes and I felt okay. But then I started having really weird symptoms had horrible, horrible cramps. I haven't had cramps in years (decades). It turned into every gland in my neck or body were inflamed and sore and I couldn't move. I was so sick. I went to my doctor and he could tell my glands were swollen on the left side they hurt but on the right side they didn't hurt but they were inflamed. I missed a week of work and I was so tired. So lethargic. Was just told that if my symptoms worsened to go to ER. I did Tylenol, Ibuprofen and vitamins and I had to use a heating pad. I'm still at this time pretty tired all the time.
44 2021-05-19 peripheral swelling 5/9/2021 - noticed rash/hives on wrists, around elbows and knees. Self treated with hydrocortisone ... Read more
5/9/2021 - noticed rash/hives on wrists, around elbows and knees. Self treated with hydrocortisone and Benedryl 5/10/2021 - rash/hives spread to whole body. continued self treatment, but went to urgent care due to limited relief. Was prescribed stronger antihistamine and topical cream. Told that steroid could stop the reaction if it can't otherwise be controlled, however that could impact efficacy of the Covid-19 immune response to the vaccine. Prescriptions provided relief, but symptoms returned as each does wore off. 5/11/2021 - woke up with swollen hands and rash/hives continued. Dunked hands in ice-water in attempt to control swelling and eventually remove wedding ring & engagement ring. Continued treatment with prescriptions mentioned above. They provided relief - was more diligent with timing doses. 5/12/2021 - Most of the rash/hives had faded. Continued treatment with prescriptions. 5/13/2021 - Symptoms subsided.
44 2021-05-19 peripheral swelling pt says she had a hot red swollen right leg that was very painful. On 4/16/21 she went to the Hospi... Read more
pt says she had a hot red swollen right leg that was very painful. On 4/16/21 she went to the Hospital ER. She had blood test and was given an US of the right leg where they found 2 blood clots. She was started on blood thinner. She was discharged and told to FU w/ PCP. On 4/21/21 she saw the doctor. She increased the blood thinner because she found a abdominal hematoma this size of two grapefruits. On 4/25/21 she was having trouble breathing and her leg was red and inflamed. She went back to the Hospital ER they thought she was having a pulmonary embolism. They did more blood work and chest x-ray. She was given Lovenox shots and took her off the blood thinner. She was discharged to go home and give herself these shots. On 4/27/21 she had a reaction to the Lovenox shot so she called her PCP. She saw the doctor on 4/29/21 she was told to continue using the Lovenox. She went back to Dr. on 5/4/21 and she was taken off Lovenox and put back on blood thinner Eliquis with doubled dosage. She was monitored. On 5/8/21 both of her legs were red and swollen and she went to her Doctors office. They did a blood test and was sent home. On 5/10/21 she went back to her PCP. Dr. office where she was sent to Hospital ER for direct admit. They did another US and a CT. They found she had blood clots in both legs. She was given IV fluids, antibiotics, was given heparin and taken off Eliquis. On 5/13/21 she was given warfarin along w/ heparin. She was discharged on 5/16/21. She still has pain and redness in both feet and legs and has been diagnosed w/ Cellulitis. She is now taking Oxycodone and Coumadin. She will see her PCP on 5/21/21.
44 2021-05-20 lymph node swelling On May 13, 2021, approximately 4 weeks after second dose of the vaccine, I developed a very severe s... Read more
On May 13, 2021, approximately 4 weeks after second dose of the vaccine, I developed a very severe stabbing ice pick headache on the left side of my head behind my eye. By May 17, 2021, the pain was so severe that I went to the emergency room but did not receive a clear diagnosis. On May 18, 2021, I began to notice a prickly sensation on my forehead and rash forming. Urgent care confirmed diagnosis of shingles on evening of May 18, I was prescribed Valtrex, Gabapentin, and an oral steroid. As of today (May 21), the shingles rash is blistering on my left forehead, eyelid, and scalp and is mildly painful, and I have a few swollen lymph nodes, but the shooting nerve headache comes back intermittently and is still very uncomfortable. I feel that this should be reported because if people could be more susceptible to shingles after the vaccine, there should be public information about this. My case was very scary with the terrible shooting nerve pain in my head and I have learned that it is very important to get treatment for shingles started as early as possible to prevent long term effects, so I think this is something people should be made aware of.
44 2021-05-23 swelling Are swelling and paralysis, fever, disorientation, headaches,
44 2021-05-24 lymph node pain Initial shot: nausea, extreme fatigue for 5 days. Second shot: immediate arm pain, warm. In the ... Read more
Initial shot: nausea, extreme fatigue for 5 days. Second shot: immediate arm pain, warm. In the first day lightheaded, limbs heavy feeling, unfocused, flushed, fatigue, hives for about an hour. Next day headache, lightheaded, neck tightness, fatigue, lymph node pain, arm pain, nausea. Next day nausea, arm pain, stomach pain, fatigue. Next day nausea and fatigue. Nausea lasted 5 days.
44 2021-05-25 lymph node swelling Swollen lymph nodes on head - preauricular nodes.; This is a spontaneous report from a contactable O... Read more
Swollen lymph nodes on head - preauricular nodes.; This is a spontaneous report from a contactable Other healthcare professional. A 44-year-old female patient received BNT162B2 (BNT162B2; Lot number: UNKNOWN) in the left arm on 06Mar2021 at 12:15 (at the age of 44-years-old) as single dose for COVID-19 immunization. Medical history included penicillin allergy. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19, since vaccination. Concomitant medication included Levothyroxine (MANUFACTURER: UNKNOWN) from an unknown date to an unknown date for an unknown indication. On 11Mar2021, the patient experienced swollen lymph nodes on head - preauricular nodes, swollen began 5 days post vaccine and still present 11 days later. It was unknown if patient received any treatment for swollen lymph nodes on head - preauricular nodes. The clinical outcome of swollen lymph nodes on head-preauricular nodes was not recovered not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
44 2021-05-26 peripheral swelling flu symptoms, chills, fever for 5 days, shallow breathing, left arm pain & swelling for 3 weeks pel... Read more
flu symptoms, chills, fever for 5 days, shallow breathing, left arm pain & swelling for 3 weeks pelvic pain, heart pain, red bumps on body
44 2021-05-26 swelling face, lymph node swelling Numbing in mouth jaw & gum, breathing wheezing problems, shortness of breath, irritations, skin & t... Read more
Numbing in mouth jaw & gum, breathing wheezing problems, shortness of breath, irritations, skin & tongue burning, messed up my monthly period, swollen eyes, swollen lymph nodes, swollen face & mouth..heart achs & discomfort.
44 2021-05-27 anaphylactic reaction have had off and on spotty bleeding but no monthly period; ringing in her ears; nausea; fever; eat h... Read more
have had off and on spotty bleeding but no monthly period; ringing in her ears; nausea; fever; eat half of what she normally ate; have had off and on spotty bleeding but no monthly period; anaphylaxis reaction; throat to stop feeling like it was closing up; severe headache; sinus pain that felt like someone punched her in the face; all over tingling sensation 20 minutes after getting the shot; chills; This is a spontaneous report from a non-contactable consumer (patient) via COVAES. A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 18Apr2021 13:15 (Batch/Lot Number: ew0151) as 2nd dose, single dose (at the age of 44-years-old) for COVID-19 immunisation. Medical history was not reported. The patient did not have any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medication within 2 weeks of vaccination. The patient has not been diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient received his first dose of BNT162B2 on the left arm on 26Mar2021 17:30 (batch/lot number: er8127) for COVID-19 immunisation and experienced extreme structural pain and severe flu like symptoms for 4 days. The patient reported that on the second shot, she had anaphylaxis reaction along with severe headache, sinus pain that felt like someone punched her in the face, and all over tingling sensation 20 minutes after getting the shot. She had to drink 3 doses of BENADRYL for her throat to stop feeling like it was closing up. She then had ringing in her ears, nausea, fever, headache, and chills for 3 days. Since then, she can only eat half of what she normally ate. She has felt nauseated for a month and have had off and on spotty bleeding but no monthly period and a lingering headache that will not go away. The patient has yet to see her doctor due to COVID restrictions. The patient recovered from chills on an unspecified date. The patient has not recovered from headache. The outcome of the remaining events was unknown. No follow-up attempts are possible. No further information expected.
44 2021-05-27 guillain-barre syndrome flare of GB symptoms including lower extremity weakness, numbness, and tingling.
44 2021-05-27 oral herpes severe outbreak of multiple coldsores, lips and inside nostrils, severe itching and tenderness of s... Read more
severe outbreak of multiple coldsores, lips and inside nostrils, severe itching and tenderness of scalp only at the back near hairline. these all occurred approximately 3 days after receiving 2nd shot. These effects are in addition to the more common and expected ones, sore arm, mild flu symptoms, etc. coldsore outbreak was unusually painful, and severe. after discovering that many others experienced similar outbreaks after receiving vaccine I thought I should report it. I sought treatment through an online telehealth doctor and received prescription for valocyclovir.
44 2021-05-27 swelling face, swelling shortly after receiving the vaccine, she developed lightheadedness, frontal headache and a feeling o... Read more
shortly after receiving the vaccine, she developed lightheadedness, frontal headache and a feeling of "fuzziness." "I knew it was going to start." She describes a globus sensation. She developed nausea without vomiting. Took 40 mg of prednisone and 25 mg of diphenhydramine. EMS was contacted. She tells me that she lost vision and couldn't see the paramedics when they arrived. Discharged from ED, then returned on 3/17/21, when she began experiencing face itchiness and flushing, numbness of her mouth and lips, throat inflammation, and vision loss. Patient took Prednisone this morning with little symptom relief. Compared to yesterday, the only new symptom is throat inflammation. 4/30/21 Primary care visit: presents to the clinic for evaluation of globus sensation. Patient reports that this has been an issue ever since she got her first dose of Pfizer COVID-19 vaccine. She feels as though there is something in her throat and feels pain or discomfort, most often in the mornings and evenings for several weeks. She feels the need to "clear" her throat often. She denies any trouble eating or swallowing. She feels as though her neck and face still appear swollen compared to her baseline, since getting the vaccine. She reports occasional post nasal drip but denies significant nasal congestion and does not feel this is the typical time for her to struggle with her allergies. She has noticed frequent nose bleeds in the past 2 weeks, now daily. She states that she will sometimes bleed up to 15-20 minutes. She has been feeling more tired and "foggy" or more forgetful in the past few weeks as well and fears this is starting to affect her work performance.
44 2021-05-28 lymph node swelling I received the vaccine on Friday at 12pm. Late afternoon: fatigue, joint pain, swollen lymph nodes o... Read more
I received the vaccine on Friday at 12pm. Late afternoon: fatigue, joint pain, swollen lymph nodes on left side of upper body, swollen left breast with pain and heaviness feeling that lasted for 2-3 days, Lupus butterfly rash on face, flu-like symptoms, spike in temperature to 100º, dizziness, heat radiating off body, and migraine. I took my prescribed Meloxican (for Lupus joint/muscle pain) approx 2:30pm and then my prescribed Fioricet for the migraine. Friday evening: Approximately 8pm I broke out in hives on my trunk; stomach, chest, shoulders, and back. The migraine worsened to include nausea with sensitivity to light, sound and smell. I took my prescribed Zomeg with no relief. The migraine was so severe that it kept me in bed with pain for hours that once I had some relief to be able to stand to go look in the mirror at the hives, it was approximately 1am. I put hydrocortisone cream on the areas I could reach and took Benadryl. It took over an hour to fall asleep. Saturday: I took Allegra. The hives were still prominent and itchy. Sunday: The hives were still there but most were on my shoulders and back, while some still remained on my stomach but not as prominent. The hives were still itchy. The other symptoms have subsided except the migraine, which was dull, and fatigue. Monday: The hives were not as prominent but somewhat itchy. They were some remaining on my shoulders. They other symptoms subsided with the exception of a dull migraine which I managed with Fioricet. I made the first available appointment with my primary doctor. Tuesday: I saw my primary doctor. Per my physician I still have hives on my trunk. I was instructed to continue with interventions. As of 5/19/2021, I had been treating the hives, fatigue, and migraines which occurred unexpectedly. The hives have subsided completely by Thursday, 5/20/2021.
44 2021-05-29 lymph node swelling fever 99.7; swollen lymph node in right armpit; headache; chills
44 2021-05-31 lymph node swelling body aches (like growing pains in the joints); I was fatigued; Arm where vaccine was given was sore;... Read more
body aches (like growing pains in the joints); I was fatigued; Arm where vaccine was given was sore; I was very cold; swollen lymph node in the armpit of the arm where vaccine was given.; Chills lasted until about 24 hours after vaccine was given; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL 9264), via unspecified route of administration in the left arm on 05Feb2021 at 06:30 PM, as single for COVID-19 immunization at Public Health Clinic. The patient's medical history included hypothyroidism, high cholesterol, acid reflux, gallbladder stone, overweight and seasonal allergies that last all year. The patient was not allergic to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), omeprazole, montelukast sodium (SINGULAIR), levocetirizine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: E13247), via an unspecified route of administration in the left arm on 14Jan2021 at 06:30 PM, as single dose for COVID-19 immunisation. On 06Feb2021 at 07:30 AM, 12-13 hours after the vaccine: body aches (like growing pains in the joints), she was fatigued, was very cold. Arm where vaccine was given was sore and swollen lymph node in the armpit of the arm where vaccine was given. Chills lasted until about 24 hours after vaccine was given. Body aches went away about 30 hours after vaccine was given. Swollen lymph node still swollen 2.5 days after vaccine. Took Tylenol about 19 hours after vaccine and it seemed to take the edge off the aches. Took 1 more dose of Tylenol 6 hours later and that's all she needed. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events body aches (went away about 30 hours) and chills (was lasted until about 24 hours) was recovered on 07Feb2021; swollen lymph node was not recovered; for rest of events was recovering. Follow-up attempts are completed. No further information is expected.
44 2021-06-01 oral herpes Irregular menstruation not otherwise explained by early menopause. I?m always have a very regular cy... Read more
Irregular menstruation not otherwise explained by early menopause. I?m always have a very regular cycle and it became erratic after receiving the vaccine. With my cycle going from 27-28 days to anywhere from 10-23 days. Also very heavy clotting and menstrual pain. Have never expelled clots in such a manner other than after childbirth. I do get cold sores, usually about once sometimes twice a year. I?ve had four since the vaccine. Sharp pain in my right ear not otherwise explained by infection and not present prior to vaccines. Feels like an ear ache: comes and goes.
44 2021-06-02 lymph node swelling swollen lymph nodes; she has a tumor on her kidney.; she had the first dose of the Pfizer covid 19 v... Read more
swollen lymph nodes; she has a tumor on her kidney.; she had the first dose of the Pfizer covid 19 vaccine on 6Jan2021 and the second dose on 23Jan2021.; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in right arm in a hospital facility on 23Jan2021 11:00 (at the age of 44-year-old) (Batch/Lot Number: Z9262) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient had no prior vaccinations within 4 weeks. Medical history included anxiety. The patient's family history includes her dad with diabetes and her mom had high blood pressure. Concomitant medication included hydroxyzine pamoate taken for anxiety from Sep2020 to an unspecified stop date. Historical vaccine includes the first dose of bnt162b2 (lot number: EJ1686) administered in the right arm on 06Jan2021 at 10:00 AM (at the age of 44-year-old) for COVID-19 immunization. The patient stated that she had the first dose of the Pfizer covid 19 vaccine on 06Jan2021 and the second dose on 23Jan2021. The patient had a computerized tomogram (CT) scan on 03Apr2021 and saw a specialist on 14May2021. The specialist informed her that she has a tumor on her kidney on 14May2021. Patient stated that she will see a surgeon on 08Jun2021. The patient stated that she wanted to avoid extra expenses and avoid surgery if this was related to the vaccine like swollen lymph nodes and mammograms. Patient wanted to know if this has been reported. The patient added that on 08Jun2021 she will be going to a kidney specialist; on 01Jun2021, she was scheduled for a magnetic resonance imaging (MRI) follow up. Patient also added previously that she was going to have a surgery for her stomach called lower anterior resection but now she does not know what will happen. Stated she has a follow up on 28May2021 to find out what he will do. Mentioned that the she went to see the stomach doctor for issues she was having with her stomach and he ordered the CT scan and then referred her to the kidney specialist. No further information provided regarding stomach issues. The event kidney tumor did not require emergency room visit. The patient visited physician office (stomach doctor) for issues with her stomach and he sent her for the CT scan and referred her to the kidney specialist. Furthermore, patient added she heard to wait a couple of weeks before or after the vaccine to get a mammogram and she thought she would ask about the CT and if anyone else had reported what she had with her kidney. The patient underwent lab test and procedure which includes CT scan on 03Apr2021 which showed kidney tumor. The patient had not yet recovered from kidney tumor while outcome of the other events was unknown. Follow-up attempts are needed. Further information is expected.
44 2021-06-02 oral herpes Felt flushed and itchy right after. Broke out in cold sores within 28 hours of second shot.
44 2021-06-02 peripheral swelling Arm swelling/soreness, nausea, chest was hurting (found spot on the lung), coughing hard causing blo... Read more
Arm swelling/soreness, nausea, chest was hurting (found spot on the lung), coughing hard causing blood to come out
44 2021-06-02 peripheral swelling Swelling began bilaterally in ankles. Swelling continued and spread to feet, toes, knees, wrists, ha... Read more
Swelling began bilaterally in ankles. Swelling continued and spread to feet, toes, knees, wrists, hands, and fingers over the following weeks. Pain increased over this timeline as well. Still unknown what is causing the issue.
44 2021-06-04 swelling face headache; lightheadedness; facial swelling; This is a spontaneous report received from a non-contact... Read more
headache; lightheadedness; facial swelling; This is a spontaneous report received from a non-contactable healthcare professional. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration and unspecified anatomical site on 16Mar2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 16Mar2021, during 15-minute waiting period after the vaccination, the patient experienced headache, lightheadedness, dizziness and facial swelling. The patient was treated with water, snacks and TYLENOL. The response to treatment was excellent. The patient was discharged on 16Mar2021 as she was stable to go home and was advised to follow up with the primary care physician. The clinical outcome of the events headache, lightheadedness and facial swelling were unknown. No follow-up attempts are needed. No further information is expected.
44 2021-06-04 swelling face Facial swelling; This is a spontaneous report received from a contactable consumer. A 44-year-old fe... Read more
Facial swelling; This is a spontaneous report received from a contactable consumer. A 44-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER2613) via an unspecified route of administration in left shoulder muscle on 12May2021 13:25 as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccinations within four weeks prior to the first administration date of vaccine. The patient received second dose of BNT162B2 in left shoulder muscle on 02Jun2021 (Batch/Lot Number: EP7533) for covid-19 immunisation. The patient experienced facial swelling approximately 5-7 days after the administration of first dose of the vaccine. She did not have a time and stated it was when she woke up throughout the day and lasted for a week being very obvious and it started residing a little. She still has it now. It was more on right side initially than left. Then it looked like generalized swelling of whole face. It has gone down and she still has generalized swelling on her face. She did not receive any medical treatment for this. Outcome of the event was recovering. Information on Lot/Batch number was available. Additional information has been requested.
44 2021-06-07 lymph node pain, lymph node swelling -ARM AT PLACE OF INJECTION WAS ITCHY AND LARGE RED ROUND (BASEBALL SIZED RING) SURROUNDED THE AREA.... Read more
-ARM AT PLACE OF INJECTION WAS ITCHY AND LARGE RED ROUND (BASEBALL SIZED RING) SURROUNDED THE AREA. NOW SWOLLEN, JUST LARGE RED CIRCLE. -LEFT LYMPH SWELLING/IRRITATED AT LEFT CLAVICLE. WAS VERY UNCOMFORTABLE. -MULTIPLE BRUISES ON SEVERAL PLACES ON LEFT ARM/WRIST
44 2021-06-07 lymph node swelling, lymph node pain Series 1 : Enlarged lymph notes bulging from Left side of neck Series 2: severe abdominal pain, sev... Read more
Series 1 : Enlarged lymph notes bulging from Left side of neck Series 2: severe abdominal pain, severe vomiting, nausea, H/A, chills. Swollen lymph nodes in neck are tender and painful to touch.
44 2021-06-08 lymph node swelling I had a lymph node on the side of my chest wall.
44 2021-06-08 peripheral swelling Anytime I exerted myself it get worse so I went to the hospital and they admitted me because they co... Read more
Anytime I exerted myself it get worse so I went to the hospital and they admitted me because they couldn't control my angina; Bypass had developed a huge blood clot; Hematoma on her arm a couple of days later after that she got it was swollen, bruises she got nose bleed.; Chest Pain; Nose bleed; Light headedness/light headed and dizzy; Hematoma on her arm a couple of days later after that she got it was swollen, bruises she got nose bleed.; Hematoma on her arm a couple of days later after that she got it was swollen, bruises she got nose bleed.; My arm hurt; This is a spontaneous report from a contactable consumer (reported for herself) via the Pfizer sponsored program. A 44-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left upper on 07Apr2021 (Batch/Lot Number: ER8735) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 44 years old. Medical history included coronary artery disease, Microvascular disease, migraine, Bypass of LAD artery with my LIMA artery, angioplasty, had open heart surgery before, all from an unknown date and unknown if ongoing. Historical vaccine included first dose of Pfizer COVID-19 Vaccine on 10Mar2021 at the age at vaccination of 43 years old (got the first shot in right upper arm) for covid-19 immunization. Concomitant medications included clopidogrel bisulfate (PLAVIX); lisinopril; amlodipine; rosuvastatin calcium (CRESTOR); fluoxetine hydrochloride (PROZAC); clonazepam (KLONOPIN), Nexletol (further clarification unknown). The patient experienced anytime i exerted myself it get worse so i went to the hospital and they admitted me because they couldn't control my angina on Apr2021 with outcome of unknown, bypass had developed a huge blood clot on Apr2021 with outcome of unknown, chest pain on 19Apr2021 with outcome of not recovered, nose bleed on 08Apr2021 with outcome of recovered on unknown date, light headedness/light headed and dizzy on Apr2021 with outcome of unknown, hematoma on her arm a couple of days later after that she got it was swollen, bruises she got nose bleed (hematoma) on Apr2021 with outcome of recovered on 19Apr2021, hematoma on her arm a couple of days later after that she got it was swollen, bruises she got nose bleed (Bruising of arm) on an unspecified date with outcome of unknown, hematoma on her arm a couple of days later after that she got it was swollen, bruises she got nose bleed (Swelling arm) on Apr2021 with outcome of unknown, my arm hurt on Apr2021 with outcome of unknown. The patient underwent lab tests which included lipids: unknown (had lipid channel), something checking for heart stress: unknown, both on unknown date. Therapeutic measures were taken as a result of angina attack, chest pain, nose bleed, hematoma, Bruising of arm, Swelling arm and Pain in arm. Seriousness for events "anytime i exerted myself it get worse so i went to the hospital and they admitted me because they couldn't control my angina" and "bypass had developed a huge blood clot" was hospitalization, medically significant. The patient was hospitalized for both events from 20Apr2021 to 23Apr2021. Events chest pain, Light headedness/light headed and dizzy resulted in Emergency Room Visit. Additional information: Transferring agent stated, "I have patient on the line today and the reason for my transfer today is that she is having adverse effects from the COVID-19 Vaccine, she did clarify it is the Pfizer COVID Vaccine and she is experiencing hematoma on her arm a couple of days later after that it was swollen, bruises she got nose bleed as well and on 19th April that she was experiencing chest pain she went to ER and they were thinking it was cause of the COVID Vaccine as well." Consumer stated, "On 07Apr2021, I have the LOT number and everything of the vaccine I received for both of them on 07Apr2021, I got the Pfizer the second Pfizer shot and I developed a hematoma on my arm which was as big as a baseball. It was really swollen and I take blood thinners and on the next day on 04-08, I started getting a lot of nose bleed. I never get a nose bleed and so I called my doctors and asked what should I do and she said stop taking your blood thinners so I stopped taking the blood thinners and then may be after 7 days, I started taking my blood thinners again. So, it took about 3 weeks for the hematoma to go away on 04-19th, I had a huge chest pain, I have had open heart surgery before and I had to go to the ER because I felt light headed and dizzy. My arm hurt, my chest, I took nitroglycerine (treatment) and it made still little better but anytime I exerted myself it gets worse so I went to the hospital and they admitted me because they couldn't control my angina and my cardiologist did an angioplasty (Further clarification unknown) and he found that my 2019, I had a bypass of LAD artery with my LIMA artery (Medical History) and he found that my bypass had developed a huge blood clot and failed. So, basically I am looking at go in and having another bypass using my LIMA artery but the surgeon, the coronary surgeon that I talking he wanted me to call Pfizer to let you guys know because he said that that is so weird that it failed and the shot and everything and he just wanted you guys to be aware and you know that's what we wanted safety because I know that when I went in I had a lot of a questions and none of my doctor could answer. It says I shouldn't take it if I am on blood thinners but they said it is still better than you getting COVID so I went ahead and took the shot but actually now I have to get a bypass again. It might be from the vaccine, it might not be from the vaccine but the timings is just you close together there." Patient took Nitroglycerin, she was on now but that's because of the chest pain so that was on before she had the chest pain when she had the shot (Further not clarified). When probed of the event is still ongoing: Consumer stated, "Yes, because my By pass graph is now failed." Treatment: Patient took Tranexa (name not clarified). It was a medicine for her chest pain. Outcome: Consumer stated, "As in nose bleed and bleeding are gone, now it is just chest pain". Follow-up attempts are completed. No further information is expected.
44 2021-06-08 swelling May 28, 2021: post 2nd vaccine: muscle pain, stiffness, swelling.
44 2021-06-09 white blood cell count increased Not sure if related but one month after second dose I was hospitalized with Pericarditis. I was othe... Read more
Not sure if related but one month after second dose I was hospitalized with Pericarditis. I was otherwise health prior and no heart issues before.
44 2021-06-10 peripheral swelling developed 'bumps' that are big like mosquito bites; left hand started tingling, pain, itching and gr... Read more
developed 'bumps' that are big like mosquito bites; left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection); left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection); left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection); left arm really swollen; left arm really swollen and irritated; This is a spontaneous report received from a contactable consumer or other non hcp. A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0182), via an unspecified route of administration in Arm Right on 03Jun2021 (age at vaccination 44years old) as single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus diagnosed from 20 years ago. The patient's concomitant medications were not reported. She received her first dose of the Pfizer Biontech Covid 19 vaccine on 03Jun2021 in right arm/shoulder. On 05Jun2021, she started have problems with opposite side; left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection) and then she noticed the 'bumps'. Not only bumps but also itching and left arm really swollen and irritated. So to clarify, on the left side, she has 8 bumps on arm and elbow and one on her index finger. On her right side, she has one bump on right index finger and one on right arm (that was just noticed today). The area is Irritated, and she has tried cortisone, alcohol, hair dryer, but nothing is working. She took Benadryl last night and it helped her to get some sleep. The bumps are getting worse; they are not as swollen today, compared to yesterday. This was about mid-night on 05Jun2021. she has these little bumps, some are really big bumps, kind of like mosquito bites. there is no bite puncture, the bumps are hard and itchy. It is the same reaction she gets to a mosquito bite. she knows everybody is different. The bumps are hard and risen and hot to the touch and just itchy. her whole arm where the bumps are just itches. the bumps are on both hands, especially worse is on the left hand. The outcome of the events was unknown. Therapeutic measures were taken as a result of developed 'bumps' that are big like mosquito bites, left hand started tingling, pain, itching and gradually migrated up her left arm, left hand started tingling, pain, itching and gradually migrated up her left arm, left hand started tingling, pain, itching and gradually migrated up her left arm, left arm really swollen, left arm really swollen and irritated. Follow-up (07Jun2021): This is a follow-up spontaneous report from a contactable consumer. This 44-year-old female consumer (patient) reported that: Report Type, HCP postal address, Dates for Reading through side effects and is getting, has like these bumps, Suspect product information, Other Products, Patient History. No follow-up attempts are needed. No further information is expected.
44 2021-06-10 swelling Woke up with extreme ear pain in right ear. Waited a couple days. It got way worse with time. Went t... Read more
Woke up with extreme ear pain in right ear. Waited a couple days. It got way worse with time. Went to urgent care. NP didn?t see an infection but was confused why I had 10/10 pain. Was given rx drops that made it worse and I had to see an ENT in the following days who determined swelling and a blockage and extreme redness.
44 2021-06-10 white blood cell count increased Nausea, pins and needles, extreme aches, migraine over the course of 4 weeks since first shot.
44 2021-06-11 peripheral swelling Patient presented to hospital on 5/28/21 after 1 week of right lower extremity swelling and shortnes... Read more
Patient presented to hospital on 5/28/21 after 1 week of right lower extremity swelling and shortness of breath found to have R sided pulmonary emboli; DVT/PE; Patient presented to hospital on 5/28/21 after 1 week of right lower extremity swelling and shortness of breath found to have R sided pulmonary emboli; Patient presented to hospital on 5/28/21 after 1 week of right lower extremity swelling and shortness of breath found to have R sided pulmonary emboli; This is a spontaneous report from a contactable Physician. A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number unknown), via intramuscular route of administration on 22Mar2021 (at the age of 44-years-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number unknown), via intramuscular route of administration on 19Apr2021 as single dose for COVID-19 immunisation. Medical history included obesity s/p Gastric bypass, iron deficiency anemia, gastritis, depression, remote history of lung surgery for empyema/lobectomy. Patient is allergic to Lanzoprazole and Vantin. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient concomitant medications were not reported. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her usual home medications (unspecified) within 2 weeks of vaccination. On 28May2021, the patient was presented to hospital after 1 week of right lower extremity swelling and shortness of breath found to have R sided pulmonary emboli. The seriousness of all the events was reported as serious (hospitalization/Prolonged hospitalization). The reporting physician stated that it was unclear regarding the relatedness between second dose of vaccine and the events, but the patient does not have any other known history to provoke DVT/PE. The patient underwent lab tests and procedures which included SARS-CoV-2 Test: Negative (Nasal swab) on 28May2021. Since the vaccination, the patient tested for COVID-19. The device (unspecified) date was reported as 29May2021. The patient received anticoagulation as treatment for pulmonary embolism. The outcome of all the events was reported as unknown. Information about batch no/lot no has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Pulmonary embolism, deep vein thrombosis, dyspnoea and peripheral swelling cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
44 2021-06-11 swelling 3 days post 2nd dose of covid vaccine I got muscle pain, swelling, stiffness in arms. Lab results, n... Read more
3 days post 2nd dose of covid vaccine I got muscle pain, swelling, stiffness in arms. Lab results, normal reference range listed 32-182/U/L.; 3 days post 2nd dose of covid vaccine I got muscle pain, swelling, stiffness in arms. Lab results, normal reference range listed 32-182/U/L.; 3 days post 2nd dose of covid vaccine I got muscle pain, swelling, stiffness in arms. normal reference range listed 32-182/U/L.; 3 days post 2nd dose of covid vaccine I got muscle pain, swelling, stiffness in arms. Lab results, normal reference range listed 32-182/U/L.; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173), via an unspecified route of administration in left arm on 25May2021 at 08:00 AM as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration in left arm on 04May2021 at 11:00 AM for covid-19 immunisation. The patient's medical history included rhabdomyolysis. The patient had known allergies to Sulfa. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 28May2021, 3 days post 2nd dose of covid vaccine, patient experienced muscle pain, swelling, stiffness in arms. Lab results, normal reference range listed 32-182/U/L. The events resulted in: Doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The outcome of the event was recovering. Information on Lot/Batch number was available. Additional information has been requested.
44 2021-06-13 peripheral swelling On June 8, 2021 I noticed right shoulder/arm pain. Went to my dr on 6/9 and he ordered a port dye st... Read more
On June 8, 2021 I noticed right shoulder/arm pain. Went to my dr on 6/9 and he ordered a port dye study (I have a Bard Power Port for iron infusions that ended in February). The port was fine, everything flowing correctly. On 6/10, my right arm was swollen and discolored. My Dr told me to go to ER. A CT scan was done and showed 2 DVTs and 1 PE. I was admitted and started on IV heparin. I was on the IV heparin until 6/13 and then was switched to oral Eloquis 10mg twice daily. It is now 6/14, and I should be discharged sometime today. I will continue to be on Eloquis for 3 - 6 months.
44 2021-06-13 swelling Received Shot, experienced dizziness, confusion immediately Evening of first day: was tired, did not... Read more
Received Shot, experienced dizziness, confusion immediately Evening of first day: was tired, did not feel "right". Next Day: Very tired, but hands and muscles in legs began to ache 2 days after shot: Stomach became severely swollen and painful. Felt like an endometriosis flare. Had extreme diarrhea for three days. Voiding roughly 12 times per day. Sore rectum, lower stomach, intestines. These symptoms of soreness lasted for 3 days or so. 3 days after shot: severe sadness. Crying, couldn't shake it. Pain all over body. Over the next week my body became more and more sore. My feet began to cramp and fold inwards like they were trying to bend in half. I could not sit on any hard surface as my legs and back hurt too bad to sit on anything but piles of pillows. I could not walk well as my feet were very sore. A week after shot began feeling electric shock feelings throughout my legs. Zaps of electricity. Hands still very sore. Legs felt like I'd lifted weights for a week. Day 10 following shot still experiencing severe pain. Heart began racing. Resting heart rate would jump to 130 upon standing. Still having episodes of heart racing. Forearm began spasming and would cause my middle and ring fingers on my right hand to contract and close against my palm. Could not hold right hand steady. Still experiencing pins and needles in hand and arm. Spasming and contractions stopped after a few days. While I understand that many of these are known side effects, I was also lead to believe that these side effects would last 3 days or so. These have lasted well beyond that window.
44 2021-06-15 anaphylactic reaction Patient had a reaction to the Pfizer vaccine. Patient complained of itchy throat, puffy eyelids, an... Read more
Patient had a reaction to the Pfizer vaccine. Patient complained of itchy throat, puffy eyelids, and anaphylaxis reaction 15 minutes or so after the vaccine was given. Patient was given EpiPen IM, Benadryl 25 mg 2 tab. Patient was stabilized onsite, then she advised to go to ER upon discharge. Patient recovered.
44 2021-06-15 peripheral swelling After receiving the 1st dose a pain presented in the arm and swelling. After weeks strong pains bega... Read more
After receiving the 1st dose a pain presented in the arm and swelling. After weeks strong pains began in the bones that extended throughout the whole body. With cause to this I have been unable to exercise because the pain is too strong.
44 2021-06-15 swelling face PATIENT DEVELOPED PUFFINESS OF THE EYES, A SENSATION OF "FULLNESS" IN THE FACE, THE SENSATION OF PIN... Read more
PATIENT DEVELOPED PUFFINESS OF THE EYES, A SENSATION OF "FULLNESS" IN THE FACE, THE SENSATION OF PINS AND NEEDLES IN BOTH ARMS, AND THE FEELINGS WORSEN UPON STANDING UP. A BANOPHEN 50 MG WAS ADMINISTERED ORALLY ALONG WITH A BOTTLE OF WATER AND ASKED TO WAIT LONGER IN THE LOBBY. PATIENT STATED FEELING BETTER APPROXIMATELY 10 MINUTES AFTER TAKING THE BENADRYL AND INSTRUCTED TO TAKE ANOTHER DOSE OF BENADRYL 4 TO 6 HOURS LATER IF NEEDED.
44 2021-06-16 lymph node swelling, swelling Blisters on the arm where vaccine was given, swelling of the lymph nodes under arm pit all the way u... Read more
Blisters on the arm where vaccine was given, swelling of the lymph nodes under arm pit all the way up to my neck, fever of 102.5, chest felt tight of tough to breathe, rapid heartbeat. Sweating, one week later lymph nodes still some swelling, and new fever 1 whole week later. 101.
44 2021-06-16 lymph node swelling Swollen lymph nodes; Chills; Soreness at injection site; This is a spontaneous report from Non-Conta... Read more
Swollen lymph nodes; Chills; Soreness at injection site; This is a spontaneous report from Non-Contactable consumer(patient).A 44-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EW10161), via an unspecified route of administration in right arm on 28May2021 at 16:15 as a single dose for COVID-19 immunisation at doctor office. Medical history included Acid Reflux and COVID-19 from an unknown date. Concomitant medication(s) included omeprazole taken for an unspecified indication, start and stop date were not reported and elderberry taken for an unspecified indication, start and stop date were not reported. The patient previously took Erythromycin, flu vaccine, flexeral and experienced allergy. On 29May2021, patient experienced swollen lymph nodes, chills, soreness at injection site. No treatment drug was given for the event. Patient was not hospitalized for the events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Apr2021.Since the vaccination, the patient had not been tested for COVID-19. The reporter assessed the event as non serious. The outcome of the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.
44 2021-06-17 lymph node pain After experiencing left supraclavicular lymph node pain for a few days, on 3/8 I woke up with a noti... Read more
After experiencing left supraclavicular lymph node pain for a few days, on 3/8 I woke up with a noticeable goiter and severs left neck/throat pain. Swallowing was painful, and my neck ached only on the left side. I went to an urgent care center after work that day and was told to see my PCP. I was able to see her on 3/10, and had thyroid labs drawn and a thyroid ultrasound. The ultrasound showed two nodules > 3.5mm, one on each side of my thyroid. The left nodule was larger. I went for more labs on 3/17, and within two days I began experiencing tachycardia, tremors, anxiety, agitation, and palpitations. I was referred to an endocrinologist and saw her on 3/24. She prescribed me atenolol, which eliminated my symptoms. On 4/1 I underwent a radioactive nucleotide reuptake exam and was diagnosed with thyroiditis. I took the atenolol for about a month and had more labs drawn, which showed I was now hypothroidotic. I was taken off of the atenolol and started on levothyroxin 50mg qd. After taking that for two months I had repeat labs that were on the high side of normal, and my dose of levothyroxin was increased slightly. I am scheduled for a follow-up thyroid ultrasound in two weeks.
44 2021-06-17 swelling face, peripheral swelling severe rash head to waist; major migraines; severe swelling in arm, legs and face; severe swelling i... Read more
severe rash head to waist; major migraines; severe swelling in arm, legs and face; severe swelling in arm, legs and face; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration, administered in left arm on 12May2021 09:30 (at the age of 44-year-old) as 2nd dose, single for COVID-19 immunisation. Medical history included allergies to tree nuts, shellfish, and lots of medications, fibromyalgia, small fibre neuropathy, brain lesions, asthma, thrombocytopenia, chronic arthritis, nerve damage in elbows and hands, and complex regional pain syndrome (CRPS). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medication included lisdexamfetamine mesilate (VYVANSE). The patient previously took the first dose of bnt162b2 on 21Apr2021 10:30 (at the age of 44 years old) in the right arm for COVID-19 immunization and experienced extremely sick, affected neurological, and increased pain in fibro with right arm still not fully better left arm same issues neurological wise. On 12May2021, the patient experienced severe rash head to waist, major migraines, and severe swelling in arm, legs and face. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with prednisone, diphenhydramine (BENADRYL), and epinephrine (epi). Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
44 2021-06-17 swelling face Severe eye and facial swelling, nasal passages became completely clogged, throat became sore and dif... Read more
Severe eye and facial swelling, nasal passages became completely clogged, throat became sore and difficult to swallow . Accompanied by headache and extreme fatigue
44 2021-06-19 lymph node swelling Systemic: Lymph Node Swelling-Mild, Additional Details: Patient had lymph node swelling in upper lef... Read more
Systemic: Lymph Node Swelling-Mild, Additional Details: Patient had lymph node swelling in upper left chest quadrant that started just a few days after vaccine admin and has continued all the way to the second dose on 6/19/21. Patient still wanted to get second dose.
44 2021-06-20 lymph node swelling 1st Dose - Headaches - Nausea - Dizziness - Faint started on 5/29-5/31 recovered and then on 6/4 sy... Read more
1st Dose - Headaches - Nausea - Dizziness - Faint started on 5/29-5/31 recovered and then on 6/4 symptoms returned progressively worse. Went to Urgent Care on 6/6 2nd Dose - Arm stiffness (6/18) - Bruising in the injection site - Swollen armpit on the injection arm (6/19 -present
44 2021-06-21 herpes virus infection Boil that turned into herpes, face numbness, ear infection, heart palpitations
44 2021-06-21 peripheral swelling Arm, bicep to elbow is swollen and shooting pain to my wrist. Also throbbing pain in my armpit.
44 2021-06-21 peripheral swelling On the eve of the vaccine, I felt a lot of pans shooting from vaccination sight down arm, felt fever... Read more
On the eve of the vaccine, I felt a lot of pans shooting from vaccination sight down arm, felt feverish, chills, fever was 101.0, The morning of the 22nd, I felt fine, but around 6 in the evening I got another fever, closer to 102.0, injection site still very sore, a week later I got another fever and it was around 101.5, a few days after that I started to get leg pain but the arm pain had subsided. Because I had had a surgery 5 weeks before the thought of blood clots was on my mind, I began stretches and walking but it seemed to make it worse. That leg swelled and started to change color, it was my left leg, I went to ER they prescribed Xarelto, I was told I had clotting from my side to my ankle and circulation restriction. Bloodwork showed positive results for blood clots. I still have some pain and swelling. I did walk with a limp for a couple weeks. Treatments with Xarelto will continue for 3 more months. I had a follow up at trilakes primary on 06/08/2021. She confirmed it was blood clots and said she believes it was vaccine related.
44 2021-06-23 peripheral swelling The second day after the vaccine . My arm became red, swollen pain and very warm. Blisters broke out... Read more
The second day after the vaccine . My arm became red, swollen pain and very warm. Blisters broke out and now burned areas.
44 2021-06-24 lymph node swelling, lymph node pain, swelling Tenderness; Extremely swollen and painful Lymph node in armpit of arm that received the injection.; ... Read more
Tenderness; Extremely swollen and painful Lymph node in armpit of arm that received the injection.; Extremely swollen and painful Lymph node in armpit of arm that received the injection.; Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection,; Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection,; Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection,; Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection,; Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection,; Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection,; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 44-years-old female patient (Non Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jan2021 07:30 as single dose for covid-19 immunisation. Medical history included drug hypersensitivity (Penicillin). Patient was allergies to Penicillin and Ceftin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), elderberry [sambucus nigra] (ELDERBERRY [SAMBUCUS NIGRA]) and zinc (ZINC). On 27Jan2021 the patient experienced extremely swollen and painful Lymph node in armpit of arm that received the injection. Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection, I'm still experiencing tenderness and the lymph node is still swollen. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of all the events was recovering. Follow-up attempts are completed. No further information is expected.
44 2021-06-27 swelling I just received my first dose of the Pfizer covid19 vaccine yesterday morning. I'm reporting this re... Read more
I just received my first dose of the Pfizer covid19 vaccine yesterday morning. I'm reporting this reaction because what I experienced is not listed as a common side effect. Approximately 3-4 hours after receiving my shot at the pharmacy, I started feeling an unusual sense of urgency just before urinating and within less than an hour, it progressed to pain similar to a urinary tract infection that I have had in the past. However, compared to the two UTIs I have experienced in the past, the pain was not felt deep in my urinary tract in my abdomen. Rather, the pain was focused right inside the urethra. There were two types of situations where I would feel the pain. The first type of situation was while I was doing nothing in particular and did not feel the need to urinate (sitting, lying down, anything), and the painful sensation would come on as a throbbing pain and then stop. Then it would start again maybe 5 minutes later. The second type of situation where I felt the pain was when I sat down on the toilet to urinate, just before the urine passed through the urethra. I would feel the throbbing pain as I felt the urine get to my urethra and then right when the urine would start coming out, the pain would stop and what I felt instead was the sensation of swollen vulva and urethra but not pain. In the past, a UTI would take several days to clear up. I would be in pain urinating for at least the first 3 days. This time, however, the pain got very intense and frequent lasting into the night, then within 14 hours of the onset of symptoms, it had stopped altogether. I'm certain it was related to the vaccine as it came about within a couple of hours after my shot and went away after 14 hours. I am not someone who gets UTIs frequently. I have only had 2 in my lifetime, and the last one was 11 years ago.
44 2021-06-28 lymph node swelling After the vaccine, my lymph nodes grew, low temp fever and body aches. I only took Tylenol. In May, ... Read more
After the vaccine, my lymph nodes grew, low temp fever and body aches. I only took Tylenol. In May, I was diagnosed with shingles. This month (June) I was diagnosed with kidney stones and fatty liver and enlarged liver. Also, something growing in my uterus, not a tumor, but something growing under the muscle.
44 2021-06-28 lymph node swelling Reactive lymph node on right side by collar bone. Monitoring. Slowly decreasing in size.
44 2021-06-28 peripheral swelling, lymph node swelling Swollen arm (started on 06/26/2021) with a warm red rash that has started on 06/28/2021. Swelling an... Read more
Swollen arm (started on 06/26/2021) with a warm red rash that has started on 06/28/2021. Swelling and soreness in armpit area that started on 06/26/2021 and has continued
44 2021-06-28 white blood cell count increased, peripheral swelling Pt vaccine reaction Timeline: May 4 11:30am - 2nd Pfizer vaccine received. 6:30pm - Slight ankle p... Read more
Pt vaccine reaction Timeline: May 4 11:30am - 2nd Pfizer vaccine received. 6:30pm - Slight ankle pain with no event or accident. chalked up to turning 45. 9:30pm - Walking is more painful and I'm a little worried but again, turning 45. May 5 AM - Began the day with a now swollen ankle (tennis ball like on the outside), sore greater toe joint and I am pretty sure this is vaccine related. No other reason I can come up with. Too coincidental. Called my doctor and she said the vaccine is creating all kinds of strange reactions, but to watch it and if it gets worse come in. PM - The day goes on and I'm not feeling horribly worse but am pretty concerned if it doesn't get better by tomorrow I'm going in. Walking is painful like nothing I've felt. Not injury pain just overwhelming pain. By bedtime (of course) the pain is constant and cannot get comfortable. My friend is helping me with ice and things and I slept between 11pm - 1am. May 6 1-3am - Walking is now excruciating and I'm really worried now. Luckily Dad was up posting on the family page here and I messaged him that I was going to the ER as soon as my friend wakes up or 7am whichever comes first. In a loving and no BS way he tells me to wake her up now and go. This is not something to wait on. This is one of the few times he has given me direction after hearing my plan. I figured I should listen for once. Woke my friend up and off we go to the ER. 3:30am - Kiss my friend and tell her to go back to bed. This may take a while. Walk slowly into ER. Sloth like, painstakingly. She watches until I'm in the door. They check me in quickly with no waiting. 4:00am - I am led to ER room 9. Doctor on duty comes in and we assess. He asks and the nurse asks several times if I turned it or some kind of incident. I said no and gave him the vaccine timeline praying they keep an open mind and don't send me home. I kept saying I know this is strange and when they even touch my ankle now it's just awful. 4:30 - X-ray, blood draw (a lot). I'm sure they needed to check my BAC, drug screen, etc etc. 5:00am - X-ray is clean, no cracks or breaks. Blood tests are a little wonky. White cell count is high. My D-Dimer (test for possible blood clot) is 2x normal so they think blood clot and order the sonogram. She is on call so will be 30min before she gets here. 5:30am - Sonogram wheels in and she starts. She is tired and not very happy. First person to be a bit dry. She is a little rough and toward the end actually GRABBED my ankle and I screamed and nearly cried. She didn't apologize and was done shortly after. It felt like she was "wasting her time" and I prayed for her because I don't know what she's dealing with in her personal life. 5:45am - Sonogram is clean. ER doc comes in and we talk about next steps. He's called the ortho doc on call. He said he can pull some fluid from the swelling to see what we are looking at and send it to the lab to test. I said do it. 6:00am - The lidocaine usually burns, but this time I don?t even twitch because the pain is already terrible. It numbs part of the ankle so he can stick a needle in my now softball like ankle swelling. What he extracts is disgusting looking. He was hoping it was clear but it is not. Send the sample to the lab.They?ve given me an IV line and administered morphine. I don?t like that initial feeling. My whole body burns for a few seconds. It does help the pain so I deal. 7:00am - Shift change, so ER doc briefs the replacement and Ortho doc who is now in on things. Ortho doc immediately puts me in the OR schedule at 9:30am! He assures me this has no relation to the covid vaccine BUT he wants to be safe and clean the infection out if it indeed is an infection. We wait. 8:30am - I am prepped for surgery and wheeled up to the 2nd floor. I feel like this is not an infection but what do I know. Ortho doc wants those results before he cuts into me. Saved by the lab, there is no infection. Morphine has worn off by now and the surgery nurse doesn?t have the authority to administer. I said so I?m just going to sit here suffering? Over dramatic nurse shows her true colors. Time to wheel back down to the ER room 9 to get some pain relief. 9:00am - They now believe this is a reaction to the vaccine. I am admitted to the hospital and they find me a room. 10:00am - I?m in the room and so hungry, mostly thirsty. They start me on IV fluids and antibiotics. 10mg Prednisone. I guess they?re still not convinced it?s not an infection. I say better safe! At this point I can tell that my left foot, greater toe joint, is more painful than just shoe rubbing. I have aches and pains that are pretty regular, but now I cannot put a sheet or blanket on either of my feet. Throughout the day I am updating family and friends. Trying to rest and wrap my head around what?s happening. The ortho doc has scheduled another OR for 11:00 the next morning. He?s concerned about infection and saving my ankle joint from a lifetime of pain. There?s a possibility of gout as well. He goes above and beyond to talk to experts in the auto immune field and gout. Opening up my ankle would cause more pain, and if it?s not necessary they want to focus on treating this correctly. So I spend the day toughing it out with oxy every 4 hours. No food or drink after midnight. Midday - Second friend came to see me and brought my phone charger. I didn?t realize how tired the oxy was making me so we chatted a bit and then needed to nap. Due to hospital regulations, she was the only person who could come see me for the entirety of my stay. They want me to stay the night no matter what so I just hang out and watch Friends all day, messaging here and there. Napping and bored. Overnight thru morning - About 10pm, the tech for the night, 2nd nurse, tells me I need to take a shower with the special antibacterial soaps. I hobble to the shower that he started for me. The shower actually felt good and relaxing. Just a little relief. The nurse on duty was super fun and sweet. Even at 3am she was in a good mood and we talked about Great Danes and her kids. By morning, I was so thirsty and hungry, but possible surgery prevents me from eating or drinking anything unless I?m taking a pain pill. May 7 9:00am - Dr. MD and Dr. OD come visit and several tests have come back from the lab. I can see results right away in a very cool app called One Chart. This is my new favorite app . Turns out the gout test is negative. They looked for crystals in the joint sample and no crystals were found. Also, final results of infection are negative. So the surgery is called off and they finish my IV antibiotic which was almost empty anyway. At this point my ankle is swelled up all around now and my left foot, greater toe joint is swelled up now. I tell the docs my right knee is starting to have pain and my right thumb. 20mg Prednisone and as the day goes, the pain lessens. Later in the afternoon, they told me it was up to me when I wanted to leave. I could stay another night or head home with some new scripts. I was walking better and the pain seemed under control after not taking any pain meds all morning. 4:30pm - My friend came and picked me up. May 8 30mg Prednisone. 500mg Naproxen 2x daily. Saturday was good to be home. Waking up a couple times in the night with pain, but as the day goes on, it?s better. Swelling doesn?t go away, but the pain isn?t constant. May 9 30mg Prednisone. 500mg Naproxen 2x daily. Feeling much better. Swelling still there, but the pain when lying in bed, walking or just sitting isn?t excruciating. Went to dinner at a friend's house for Mother?s Day. May10 30mg Prednisone. 500mg Naproxen 2x daily. Slept all night till 7:30am. 8:30am - appointment with the Ortho Dr.. I told him my thumb and knee were worsening similar to my ankle shortly after my vaccine. I was hopeful to go back to work the next day. May 11 20mg Prednisone. 500mg Naproxen 2x daily. Unfortunately, tapering off the prednisone made walking painful by the end of the day, I had regressed. the pain and swelling flare up. May 12 Sleeping was pointless. I was up at 3am in pain. Swelling and horrible pain. 7:00am - 20mg Prednisone. 500mg Naproxen 2x daily. My right ankle, thumb and knee were twice as big again and my left foot was flaring up again only this time on the outside of the foot. 8:30am - I began by calling the Ortho doc since he was most familiar and following my case closely. I was waiting for a call back and getting scared they weren?t aware of the seriousness of the situation. 9:00am - Rheumatology called to schedule an appointment for Wednesday May 19, so one week away. I accepted the time slot and felt a bit hopeful. 9:30am - I had a call from an automated patient care robot who I informed I wasn?t improving or the same, but getting worse. A human called me back within 5 minutes and we started to figure out a plan. Dr. nurse called me back quickly and made a 3:00pm appointment. 1:00pm - Dr. called me again. He spoke to the rheumatologist I was to see in a week. They suggested putting me back on a higher dose of prednisone and instructed me to take another 10mg tablet immediately. He said he was writing me a prescription for 40mg prednisone daily, calling it in today and to start tomorrow. Evening - Walking is still terrible and I just go to bed. May 13 4:30am - Still waking up every two hours and at 4:30am in pain I give up and move to the couch. Ice, pillow and continued watching a sitcom again. 7:00am - The RX wasn?t filled yesterday so I take 4-10mg tablets to equal 40mg and I start calling the Dr again to make sure that gets filled today. Mornings are so painful. 3:00pm - Finally they push the RX through and my friend picks it up for me along with a few staples. As the day goes on I feel a little better. Stronger and less pain, but the swelling is still prevalent. 9:00pm - I go to bed and pray I sleep till 6. May 14 3:00am - I wake up in pain. Walking makes me cry. Mornings are the worst. The swelling doesn?t seem to be increasing but the stiffness and constant ache in my ankle, knee, foot and thumb are impossible to ignore. Back to the couch for more sitcom. 7:00am - 40mg Prednisone. 500mg Naproxen 2x daily. Working at the dining table is painful and I try several feet up positions to switch around to. Day through evening - Not much changes but it?s not getting worse. Standing for a short period of time seems like too much. 10:30pm - Bedtime and praying the morning is better. May 15 4:30am - Woke in pain, hobbled to the couch, more sitcom. 7:00am - 40mg Prednisone. 500mg Naproxen 2x daily. 9:30am -Third friend picked me up to go get coffee and I borrowed some compression socks from her. They do make my joints feel more stable so I?m trying those out today and overnight. 9:30pm - Went to bed sore which gives me an impression the morning will be rough. May 16 5:00am - Woke in the worst pain since this all started. I would crawl to the bathroom but my right knee is too sore to put pressure on it as well. 6:00am - 40mg Prednisone. 500mg Naproxen 2x daily. I?m taking the steroid an hour early because I can?t stand the pain. My thumb is swollen the worst it has been. Pain in both feet, right ankle and right knee. And now my shoulders and neck are feeling sore. I?m not sure if this is muscle soreness or swelling starting to happen in this area now. Noon - fatigue, nausea, full body aches. Overall gross feeling. Foggy brain and heavy eyelids. 3:45pm - trying as hard as possible to keep my feet up all day. The fear of not sleeping and waking up unable to walk without pain is overwhelming. Spending the day watching movies with my kids. 6:30pm - trying ibuprofen tonight. 800mg /8hrs. Naproxen doesn?t seem to be doing anything. 8:30pm - Going to bed. 11:30pm - Woke in pain as predicted. Slowly painstakingly hobble to the bathroom and back to bed. May 17 3:00am - As predicted, terrible pain just sitting here. Walking is excruciating. I'm gonna have to go back in for sure. 5:30am - Assessing and making decisions. Left foot swelling is down. The pain when walking feels like my foot is ripping in half. Top outside of my foot and greater toe joint feels like I?ve been stepped on by a horse. Right foot and ankle swelling is down a bit. Feels like I?ve severely sprained several parts of it. All the little joints are struggling in my feet. Right knee swelling is worse. The pain is still bad. Feels like stabbing above my kneecap and possibly dislocated. The right side also has a stabbing pain. Trying to walk is unbearable. Right thumb is the worst it?s been yet. Swollen and painful to touch. Not sure if I will be able to work today since it?s my mouse hand. I can?t hold a pen correctly. 8:00am - Called the dr and left a message to help figure out a pain plan or I?m going to have to return to the ER. Waiting on call back. 10:45am - Dr. is prescribing me a higher dose non narcotic pain killer. Tramadol. Also contacting the rheumatologist I?m seeing Wednesday. Not sure what to do for me until they evaluate me. Not much urgency in that department but he?s trying to push me through. 12:45pm - Dr. called and recommended going to the ER main campus. He is out of his element now and wants rheumatologist to get on this. 1:00 - at ER 1:30pm - blood draw then waiting. 3:30pm - Ortho team and Rheumatologist shows up. Tells me more of what I know. Ortho wants to aspirate my ankle again. This time it hurts bad. Great doctors though. 4:00pm - sounds like they?re admitting me. 5:24pm - waiting for someone to take me to a room. Staying until the pain is managed. Hopefully a day or two. My symptoms are very unusual and atypical is what I keep hearing. Looks like infection, but it?s in multiple joints. Multiple joints make them think of some sort of autoimmune disorder. My pain fluctuations are confusing to them. The prednisone should have taken the swelling down within the first few days. Two weeks later I?m back in the ER. 9:45pm - Made it to the room. May 18 4:30am - Woke in pain and the swelling is still here. You would think that staying off my feet would help but it actually makes things worse it seems. My knee is extra puffy today. Thumb hasn?t gone down at all. 6:15am - Another blood draw. So many fluids have been taken out of me lately. 6:45am - Ortho team came in to check on me. No infection growing. They?re still betting on a rheumatological diagnosis. 10:45am - The swelling intensifies today. No prednisone so they can get accurate blood readings. Just gave me IV toradol which is an anti inflammatory and painkiller. Praying for some relief. 11:30am - Entire team of 8 Drs came to see me today. More and more confirming this is a response from my 2nd covid vaccine. I?m feeling even more confident they will have a plan for me soon. They're loving figuring this out! They're reporting everything and making sure everything is documented. They've not seen such crazy numbers in a blood sample as they have in mine. 2:00pm - Rheumatologist and his team of 3 came up with more testing. They?re going to aspirate my knee and ankle again. This time with a precise sonogram instrument. They?re also ordering an Echocardiogram to make sure my heart valves are healthy. 3:00pm - Another fat needle in my knee AND ankle. Pulled out some fluid that wasn?t blood. Sending it through one more time to test for infection. 5:00pm - Toradol is working for pain control. Also starting me on IV steroids to see if they can get the swelling down. 9:00pm - Feels like the swelling is going down. Will see how it is in the morning. I?m hopeful!! May 19 6:00am - Best sleep I?ve had in 2 weeks. The swelling is down quite a bit. Joint pain is still there but not near as bad. 7:30am - Sonogram scheduled to look at my heart valves at 2:00pm. Ekocardiogram. No food or drink until after. 8:00am - Internal medicine doc gave me a lot of information. They still do not think it's an infection. It?s possible I have an autoimmune disorder It?s possible I have a virus in my heart and blood Most likely this is a reaction to the vaccine. My antibodies deposited in these few random joints and my immune system attacked. My liver enzymes are high which is a sign of autoimmune disorder but they?re not confirming that yet. I?m severely anemic which is another sign my body is fighting something. My entire system is inflamed so that?s another concern. 10:30am - Echocardiogram went well. Just checking my heart to make sure no virus or infection there. 2:00pm - On the dot. Sonogram of my major organs went easily even though I hadn?t eaten and was hangry. 3:30pm - another dose of IV steroids and naproxen. 4:00pm - PT visited to see how I was moving. Having to use a walker to be mobile is quite humbling. 5:00pm - Head Attending Rheumatologist came in to discuss. They are being extra sure no infection because that could cause long term damage. The heart sonogram just makes sure my heart valves aren?t infected and spreading an infection in my blood. The liver enzymes are elevated but he said they are not alarmingly high. They think if I can get the swelling down. Pain managed and confirm there?s no infection I will go home tomorrow. I will most likely need a walker and shower bench in the beginning until I get stronger, swelling goes down and pain is minimal. May 20 6:00am - Another pretty good nights sleep. I know they have a few test results they?re waiting on before sending me home. Hopefully that will be wrapped up today. I am achy this morning in those troubled joints so will take naproxen and see how the morning goes. Swelling seems a little better but it?s hard to tell this early. 7:25am - I?m feeling a lot more clear headed today and more confident about going home. I have a long road of recovery but I?m no stranger to that. 3rd friend brought me native coffee this morning. Perks of your best friend working in the same hospital you?re in. And she brought me clean clothes so she?s my hero of the day. My energy level is better today. 1:00pm - Going home today looks less likely by the conversations with the team here at UNMC. Pray they find what they?re looking for and come up with a solid plan to treat me. 2:45pm - EKG to establish a base line. 3:00pm - new IV port. Steroid IV 4:15pm - Finally get new IV after two attempts. I?m getting really sore without the steroids. 4:45pm - New culture swabs to test for more difficult to diagnose infections. They?ve almost certainly ruled out an autoimmune disorder. That?s huge! Next is rule out infection 237%. After that they call it reactive arthritis which is tough to pinpoint why it?s happening but they will treat it as best they can. 5:00pm - Finally get the steroids. Gonna take a minute to feel better. 9:00pm - Started to feel better and lost the constant dull ache in all the problem joints. My knee feels extra sore tonight so trying to find a comfortable position is tough. May 21 5:45am - Took naproxen 6:30am - Swelling is down more this morning. Still painful walking but not nearly as bad. Praying they have a solution today. 8:00am - Internal Med Dr visited with a sneak peek at their tentative plan. They won?t have the last infection test done for 3 days but they think I should be ready to go home today with a solid medication plan of steroids and naproxen. I will be monitored closely at home and have a plan of action if I have a flare up. Also follow up appointments will be scheduled out to measure progress and communicate with the medical team here. I feel truly blessed to have this team working for a solution to this unique illness. ***also my liver enzymes are back to normal and inflammatory markers are reducing. *** 8:45am - Dr. visited. Basic same story. He said the cultures from yesterday are negative but they want them to ?cook? for a couple more days. 10:30am - Infection team visits with their plan to wait for cultures to grow and treat with antibiotics if needed. 11:30am - Internal Med team visits with the same info. They?d like to get me home today. Waiting for the Rheumatology team to confirm their plan for steroid treatment when I am home. 12:30pm - I put pants on. 1:15pm - Dr. in Rheumatology stopped in and basically repeated the previous team?s comments. 3:15pm - IV steroid and confirmed I?m being discharged today. 3:45pm - Dr. Attending Rheumatologist came to explain what they know and what they don?t know. I don?t have an autoimmune disorder. I don?t have an infection that would need antibiotics. What I have is reactive arthritis which they think is responding to ?a virus.? They will not confirm or deny the COVID-19 vaccine reaction, but several think it?s covid related. Time will tell and I am on a slow road to recovery. Many follow up visits and possibly a definite answer some day. 6:00pm - arrived at home and felt so good to be there. May 22-23 Spent the weekend taking it easy. Had several helpers and food drop offs. Each day is less swelling and better range of motion. I?ll update every couple days just to keep a log of recovery. May 25 6:00am - I don?t want to jinx it but the swelling in my knee is down even more this morning. Left foot is almost pain free. Right ankle looks really good considering. Staying off my feet as much as possible seems to be working plus the steroids. Feeling encouraged. June 2 2:00pm - Followup appointment with Rheumatologist Dr. and the attending. They?re changing my prednisone to 10mg/day for the next couple of months. I go back in August as long as everything keeps getting better and I don?t have any flare ups. June 8 Today has been the best mobility I have had in a very long time. Swelling is down alot. Everyday seems to be better. June 18 Had the best day. Less pain and swelling. I was able to walk normally. June 22 Interesting new swelling and pain in my right palm. Sent pictures to Dr. and talked to him on the phone Friday. Staying on 10mg prednisone for now. June 28 All the affected joints are just sore and hard to move. My right thumb is significantly swollen. And right palm has some swelling.
44 2021-06-29 swelling, lymph node inflammation, lymph node swelling My underarm swelled up and it was sore for seven days. I had a headache, I felt like I had body ache... Read more
My underarm swelled up and it was sore for seven days. I had a headache, I felt like I had body aches all through my body, extreme fatigue. I slept for almost 24 hours. I felt very achy for all of May. In June, the swelling finally went down but then I was getting constant headaches. I went to the ER on the 23rd and I had a swelling by the nape of my hairline, near my ear. It was soft and it hurt a lot, anytime it was touched, it caused my head to hurt more. The doctor gave me antibiotics and said it was lymphnode-itis.
44 2021-06-30 peripheral swelling Patient started after pain in her left feet. Both fee have pain but the left foot is more painful th... Read more
Patient started after pain in her left feet. Both fee have pain but the left foot is more painful then the right. Foot is also swollen.
44 2021-07-03 peripheral swelling Normal immune reaction: fever, chills, headache Abnormal immune reactions developed immediately incl... Read more
Normal immune reaction: fever, chills, headache Abnormal immune reactions developed immediately including tinnitus in left ear, brain zaps or head rushes constantly throughout the day and night with and without dizziness and tingling and swelling in extremities. This has not resolved six weeks post-vaccine. Developed chest pain, vivid dreams, and head pressure/pain. I've seen an ENT specialist and the Neurologist who are calling these long-haul autoimmune reactions. It feels as if my nervous system is in overdrive and inflamed. It is debilitating and is inhibiting my daily life. I am a healthy 44-year-old woman who was in great health prior to this vaccine.
44 2021-07-06 swelling, lymph node swelling Swollen lymph node next to the clavicle on the right side. Pain to touch. Swelling.
44 2021-07-08 peripheral swelling Initially, some dizziness, racing heart and shortness of breath within half an hour of shot. We thou... Read more
Initially, some dizziness, racing heart and shortness of breath within half an hour of shot. We thought it could be because of my alcohol sensitivity, which causes similar feelings when inhaled. Nurses said I could try getting fresh air. I stood outside for 15 minutes and started to feel better, except for the racing heart beat. I went home. A few hours later, the racing heart beat came back and was worse. I had mild chest pain, an itching arm and was sweating. I called a help line and was told that can happen sometimes and that it was okay to take Tylenol now, so I did. The next day my heart was racing worse. I used a blood pressure cuff and checked my pulse rate. My BP was 181/90, which is high for me, especially on the linsopril. My pulse rate was 101 BPM. I also developed a fever and a painful and itchy rash on my arm. When I called the advice line they said that was still within non-emergency range. It went on like this for two weeks. When I saw a doctor for something else, I mentioned all of it and they said I may be allergic to the shot. I was given prednisone for symptoms related to Lupus and my swollen arm. I was told I could get the second shot a f little later than originally planned. However, even with prednisone and a pulse rate back down to 88 (high for me), I continue to have chest pains off and on. The swollen arm with a weird rash lasted for 5 weeks. I have to have a scan with contrast dye to monitor my brain tumor and insurance won?t approve them doing both at once, so still trying to schedule a look at my heart.
44 2021-07-10 lymph node pain low on energy; pain in the lymph node in the left armpit; fatigue; general body pain; chills; vaccin... Read more
low on energy; pain in the lymph node in the left armpit; fatigue; general body pain; chills; vaccination site pain; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 26Mar2021 at 10:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN), quetiapine fumarate (SEROQUEL), clonazepam (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA) and caffeine, paracetamol and ibuprofen (IBUPRO); all taken for unknown indications and from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 03Mar2021 at 08:00 (at the age of 44-years). On 26Mar2021, the patient experienced the event pain at the injection point in the left arm. On 27Mar2021 at 11:00, the patient experienced fatigue, body aches, and chills and on 28Mar, 2021 at 08:00, the patient experienced pain in the lymph node in her left armpit and the patient felt low on energy and bit achy. The persistent pain in the lymph node was the reason, the patient reported the event. Treatment was taken as a result of lymph node pain with ibuprofen 200mg. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events vaccination site pain, fatigue, general body pain, chills, lymph node pain and energy decreased was not recovered. No follow-up attempts possible. No further information expected.
44 2021-07-10 lymph node swelling Fainting Feeling; Feeling.difficulty catching my breath; Heart palpitations; Swollen lymph nodes on ... Read more
Fainting Feeling; Feeling.difficulty catching my breath; Heart palpitations; Swollen lymph nodes on my left collarbone and under left armpit; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female non pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in left arm on 23Jun2021 07:45 am as a single dose at age of 44-year-old for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in left arm on 02Jun2021 07:30 am as a single dose at the age of 44-year-old for covid-19 immunisation. The patient had no known allergies and no other medical history. The patient was not diagnosed with covid prior to vaccination and was not tested for COVID-19 post vaccination. On 24Jun2021, patient experienced swollen lymph nodes on her left collarbone and under left armpit, heart palpitations, fainting feeling and difficulty catching her breath. The outcome of events was recovering with no treatment. Information on the lot/batch number has been requested.
44 2021-07-10 swelling Skin rashes, itchiness and swelling after dose2 of mRNA vaccine
44 2021-07-11 lymph node swelling Had very bad lymph swelling after the initial dose on day 10. Breast pain and lumps under left arm, ... Read more
Had very bad lymph swelling after the initial dose on day 10. Breast pain and lumps under left arm, vaccine side, running down into my ribs and up into my neck. Random migratory pain in joints along with Muscle twitching, headache over right eye, almost felt like a shingles attack. Increased heart rate, fatigue, anxiety, insomnia. Did not seek medical care as was told that those were normal reactions. Symptoms settled day before second shot on March 23. Felt okay for a week then they started back up again but even more pronounced. Have had armpit, breast, back, rib pain that feel like burning and electrical currents, heart palpitations. Random muscle twitching. Joints have been aching and cracking. Had blood work done for lymes disease in April. Negative. In May saw an obgyn who deemed it vaccine related but could offer no treatment after testing negative to RA, Lupus, Lymes. June 14th presented to urgent care as rib and back pain had intensified. They ran an ecg. Ecg was abnormal and was transferred to ER. June 15 Went to hospital where ekg was again abnormal, lengthened qt and st segments which indicate STEMI but clinically I didn?t present any symptoms. Was referred to cardiologist for heart issues. Still suffering back, rib, underarm pain and breast swelling with sensitivity along with random muscle twitching in various areas multiple times a day. Doctors cannot figure out what is cause and say vaccine related.
44 2021-07-11 peripheral swelling, axillary mass arm swelled; My armpit swelled to size of abaseball.; I had extreme pain at theinjection site,; My g... Read more
arm swelled; My armpit swelled to size of abaseball.; I had extreme pain at theinjection site,; My groin was also painful to the touch; strange numbing sensation andweakness throughout my left side; strange numbing sensation andweakness throughout my left side; My heart raced for about 10 minutes after shot; weakness and tinglingin my arm to my fingertips; tingling in my arm to my fingertips; felt dizzy; muscle spasms on my left side into my face.; my breasts are super tender; I just feel off; foggy headed; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non- pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6208) via an unspecified route of administration in the left arm on 16Mar2021 at 14:15 (at the age of 44-years-old) as a dose 1, single for COVID-19 immunization. Medical history included Immune thrombocytopenic purpura (ITP), a really insignificant low platelet count disorder. The patient had a broken foot and a touchy stomach but that was not a real health concern. The patient was not tested allergic to anything other than pollen. It was unknown whether, the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications were reported as no. The patient did not receive any other vaccines in four weeks prior to COVID-19 vaccination. Since the vaccination, patient had not been tested for COVID-19. On 16Mar2021 at 14:15, the patient felt heart racing for about 10 minutes after shot. The patient had weakness and tingling in the arm to fingertips. The patient also felt mild dizzy. About 24 hours later on 17Mar2021, the patient noticed arm swelling and armpit was swollen to the size of a baseball. The patient had extreme pain at the injection site radiating down the arm and to the left side of the breast. The patient hated the strange numbing sensation and weakness throughout the left side. The patients groin was also painful to the touch. After a week on an unknown date in Mar2021 the swelling had gone down, but the patient had totally random and uncontrollable muscle spasms on the left side of the face. The shot site continued to hurt and the breasts were super tender. The patient felt off and foggy headed. The patient was unsure about taking the second dose. The patient was scared and did not know what to do and also did not want to not get it. strange numbing sensation and weakness throughout my left side. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the swelling arm, axillary mass were recovering, and the clinical outcome of the events heart racing, weakness in arms, tingling, dizzy, injection site pain, numbness, groin pain, muscle spasms, breast tenderness, feeling down and foggy headed, strange numbing sensation and weakness throughout my left side was not resolved at the time of this report. Amendment (26Mar2021): This follow-up report is being submitted to amend previously reported information: Additional PMH "low platelet count disorder" added. Events Physician office visit ticked. Additional coding of "Weakness left or right side" for event "strange numbing sensation and weakness throughout my left side" added, 1st Vaccine letter for NON-HCP initiated. Follow-up attempts are completed. No further information is expected.
44 2021-07-12 oral herpes breaking out with a fever blister, cold sore just outside above her lip; This is a spontaneous repor... Read more
breaking out with a fever blister, cold sore just outside above her lip; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0196), dose 1 via an unspecified route of administration, administered in Arm Right on 18Jun2021 11:10 (at the age of 44-years-old) as dose 1, single for covid-19 immunization (for health and safety, as reported). Medical history included hypothyroidism from 2008 and ongoing (Verbatim: Hypothyroidism Patient Medical continuing: Yes), shingles from an unknown date and unknown if ongoing (Verbatim: shingles Patient Medical continuing: No), cold sores from 1993 and ongoing (Verbatim: cold sores Patient Medical continuing: Yes) since she was 16 years old, botulinum toxin injection (Botox injection) from 29May2021 to 29May2021. Reportedly, additional Information for Other Conditions was this past fall. the fall of maybe 2020. it has been within the past 2 years. anywhere between fall of 2019 to fall of 2020. Concomitant medications included levothyroxine (Manufacturer of levothyro amneal) taken for hypothyroidism from 2008 to ongoing. Caller reports she received the dtap it was greater than 30 days, received tetanus shot on 23 Apr 2021. Caller states while we are documenting everything, she does receive Botox injections in my forehead. She is wondering if that should be noted. She reports she received a Botox injection 29 May 2021. On 22Jun2021 07:00, the patient experienced breaking out with a fever blister, cold sore just outside above her lip. Reporter seriousness for breaking out with a fever blister, cold sore just outside above her lip was unspecified. Event breaking out with a fever blister, cold sore just outside above her lip was reported as worsened. She received first dose of the vaccine last Friday. She is reporting breaking out with a fever blister, cold sore just outside above her lip, states that it is progressively getting worse. Suspect product: Lot number: EW0196, She thinks it is a 9 or a 4. She thinks it could be a 9, 7 or 4. Caller confirms she received vaccination on 18 Jun 2021. No Emergency Room and Physician Office visit. Outcome of the event was not recovered. Description of complaint: Levothyroxine: Caller states the NDC, Lot number, and expiration date are probably on the paper work they print out but it is not on the bottle. Product strength and count size dispensed: 125mcg Follow-up attempts are needed. Additional information been requested.
44 2021-07-12 swelling On the 27th and 28th I felt kind of tired and slept a lot. The next week I was fine. Around 6/16, I ... Read more
On the 27th and 28th I felt kind of tired and slept a lot. The next week I was fine. Around 6/16, I saw what I thought was a mosquito or spider bite. It was just an itchy red bump, so I didn?t pay much attention to it. By the 6/21, the hives started coming up a little. On 6/26, it got bigger, and it was spreading on my back. I went into the ER thinking it was a spider bite. They took a look and diagnosed me with shingles. I was given gabapentin and an anti-viral. I had a bad reaction to the gabapentin, so I took it once and stopped. The antiviral is done, and the rash has crusted over and came off. I still have pain on my left side that I have ever experienced before. I am following up with my doctor regarding this.
44 2021-07-15 lymph node swelling Had immediate tingling in left arm, fast heart beat. Lymph nodes swelled very large in neck. Exactl... Read more
Had immediate tingling in left arm, fast heart beat. Lymph nodes swelled very large in neck. Exactly 1 wk later right knee swelled & was unable to bend. By next morning couldn?t feel leg was numb & tingling. Next day broke out in rash all around trunk area.
44 2021-07-17 peripheral swelling fingers really swollen; tight chest; Wheezing; headache; Rash on body; This is a spontaneous report ... Read more
fingers really swollen; tight chest; Wheezing; headache; Rash on body; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8732) via an unspecified route of administration in the left arm on 25Mar2021 at 14:45 (at the age of 44-years-old) as single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA) and celiac disease. The patient had a history of allergy to sulfamethoxazole, trimethoprim (BACTRIUM), penicillin, nitrofurantoin (MACROBID) and gluten. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 15.30, the patient experienced headache within 30 minutes and rash on body that night then next day morning woke up to fingers really swollen, tight chest and wheezing. The patient received benadryl and advil as treatment advised by doctor for the reported events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the rash, headache, finger swollen, tight chest and wheezing was not resolved. No follow-up attempts are needed. No further information expected.
44 2021-07-19 c-reactive protein increased As described by patient, "I had a reaction 10 minutes after I got it." Facility laid her down and mo... Read more
As described by patient, "I had a reaction 10 minutes after I got it." Facility laid her down and monitored for 30 minutes [Reporter does not know details of this reaction.] No other adverse effects reported until 2 days later. Patient reports that upon awakening (7/11/21), her near-sighted vision was very blurry and doubled. Double/Blurry vision continued for multiple days, prompting an ER visit for workup, since patient unable to report to work with vision problems. Patient was seen in ER on 7/14/21. CAT scan unremarkable. As reported by patient, "My cat scan looked okay. They have me Decadron and it helped my vision some, so he's sending me home on steroids. He said the immune system is in overdrive trying
44 2021-07-20 peripheral swelling caused her back to be in so much pain that she still can't walk 4 days later; still can't walk 4 day... Read more
caused her back to be in so much pain that she still can't walk 4 days later; still can't walk 4 days later; depression was ten times worse than it was before the second vaccination; feeling like sick; 101 fever for two days; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; Headache pounding; nausea; fatigue; swollen gums; can't eat; I'm in very bad shape; crying; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 27Mar2021 at 12:00 (at 44 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included bipolar, asthma, hypothyroidism, and depression; all from unspecified date. The patient had no known allergies. Concomitant medications included quetiapine fumarate (SEROQUEL), lurasidone hydrochloride (LATUDA), clonazepam (KLONOPIN), lithium, and levothyroxine sodium (LEVOTHYROXIN); all from unspecified date for unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 06Mar2021 at 13:15 (at 43 years old) as single dose for COVID-19 immunization. The patient did not have COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient reported that after her second shot (27Mar2021 at 12:00), in the middle of the night, the patient woke up feeling like sick like someone hit her with a truck. A 101 fever for two days, pain and swelling under her arms and at the injection site. Headache pounding, nausea, fatigue, all of a sudden it caused her back to be in so much pain that she still can't walk 4 days later, swollen gums, can't eat, her depression was ten times worse than it was before the second vaccination. The patient stated she was in very bad shape since this happened on 28Mar2021 (Sunday). The patient also added "I beg you to study the effects of this injection on people with a mental illness. I'm still crying." The start date of the event was on 28Mar2021 at 04:00. The events caused her back to be in so much pain that she still can't walk 4 days later, still can't walk 4 days later, and depression was ten times worse than it was before the second vaccination were considered medically significant. All events resulted in physician office visit. No treatment received for the events. Outcome of crying and still can't walk 4 days later was not recovered, while the rest of the events was recovered with sequelae on unspecified date in Mar2021. Information on batch/lot number has been requested.
44 2021-07-20 swelling face significant swelling underneath both eyes; significant swelling of cheeks; face aches; This is a spo... Read more
significant swelling underneath both eyes; significant swelling of cheeks; face aches; This is a spontaneous report from a contactable healthcare professional, the patient. A 44-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 12:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included facial filler which was done on Nov2020, COVID-19 and known allergic to sulfa drugs. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 19:00, the patient experienced face aches. On 19Mar2021, the patient woke up with significant swelling under both eyes and cheeks. The patient was nervous about second dose which was scheduled on 04Aug2021. The adverse events did not result in doctor or other healthcare professional office/ clinic visit/ emergency room/ department or urgent care. Therapeutic measures were taken as a result of adverse events included BENADRYL and CLARITIN for over a week and the reactions were slowly subsided. The clinical outcomes of the events face aches, swelling underneath both eyes and significant swelling of cheeks were resolved with sequelae on an unspecified date of Mar2021. No follow-up attempts are needed. No further information is expected.
44 2021-07-21 lymph node swelling Inflamed swollen area; Funny taste in mouth; 102.7 fever 2 days; Swollen sore lymph nodes under arm;... Read more
Inflamed swollen area; Funny taste in mouth; 102.7 fever 2 days; Swollen sore lymph nodes under arm; Swollen red rash on arm; Redness started at injection site little below shoulder and has spread to elbow; sore to touch; itchy; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 30Mar2021 at 13:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and asthma. The patient had history of allergy to cheyenne pepper, almonds, pomegranate seasonal allergies. Concomitant medications included metformin (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA) and fluticasone propionate (FLONASE), all from unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 09Mar2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 08:30, the patient experienced 102.7 fever 2 days, swollen sore lymph nodes under arm, swollen red rash on arm. Redness started at injection site (little below shoulder) and since Tuesday had spread too elbow. The inflamed swollen area was warm, sore to touch, and itchy. A funny taste in mouth. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events and included treatment with ice area and ibuprofen (MOTRIN). The clinical outcomes of 102.7 fever 2 days, swollen sore lymph nodes, swollen red rash, redness at injection site, inflamed swollen area was warm, sore to touch, and itchy, funny taste in mouth were not resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
44 2021-07-21 lymph node swelling Swollen lymph nodes in armpit and back of neck on right side.; This is a spontaneous report from a c... Read more
Swollen lymph nodes in armpit and back of neck on right side.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 31Mar2021 at 15:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to codeine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 10Mar2021(at the age of 44-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 00:00, the patient experienced very swollen lymph nodes in armpit and back of neck on right side. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event swollen lymph nodes in armpit and back of neck on right side was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
44 2021-07-25 lymph node swelling left hand pain , I had body pain , hand was heavy , limp nods on both of my shoulders just below my... Read more
left hand pain , I had body pain , hand was heavy , limp nods on both of my shoulders just below my ears (on the collar bone) , heavy overflowing Menstrual cycle , lump in my left breast. headach
44 2021-07-27 lymph node swelling, lymph node pain She had an egg on her arm, that also had a red rash; Swollen lymph nodes and armpit; Lymph node pain... Read more
She had an egg on her arm, that also had a red rash; Swollen lymph nodes and armpit; Lymph node pain, under armpit; Tiredness; Bad migraine, after first vaccine.; Soreness left arm injection site: described as red dot and small swelling at injection site, with warmth radiating from the site, after first vaccine; Soreness in her arm; Red rash at injection site/red dot at the injection site; Small swelling at injection site; Warmth radiating from the site; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/Lot number (Lot: caller reports EW, then caller thinks it is zero, then reports the numbers 167) was not reported; Expiration Date: 31Aug2021), dose 1 via an unspecified route of administration, administered in Arm Left on 13May2021 at 10:00 as DOSE 1 (Patient Age at Time of Vaccination: 44 years), SINGLE for covid-19 immunisation (last Thursday the patient got her first shot). Medical history included multiple allergies from Oct2000 and ongoing (Caller states the allergies are unspecified for report, and provides no specific details for the medications, or NDC, Lot, or expiration dates), back injury from Oct2000 to an unknown date (caller states the allergies started after back injury Oct2000). The patient's concomitant medications were not reported. Caller states that she is disabled, but does not want to report her medications. Caller states she did not panic, and go to the emergency room, unless she cannot breath, which has happened with some of her other allergies. The patient experienced soreness left arm injection site: described as red dot and small swelling at injection site, with warmth radiating from the site, after first vaccine on 13May2021 at 17:00 (she got the shot at 10 am, and by 5 pm, her arm soreness began), bad migraine, after first vaccine on 15May2021, tiredness on 16May2021 (Caller states that by Saturday or Sunday, she had bad migraines, and she was tired), swollen lymph nodes and armpit on 17May2021, red rash at injection site/red dot at the injection site on 13May2021, small swelling at injection site on 13May2021, warmth radiating from the site on 13May2021, lymph node pain, under armpit on 17May2021 (Caller states on Monday, Tuesday and Wednesday, she had lymph node and under her armpit), soreness in her arm on 13May2021, she had an egg on her arm, that also had a red rash on 21May2021 (Caller states last night she had an egg on her arm, that also had a red rash, Caller states the rash is spreading up to her shoulder/ caller states she initially noticed this event when rubbing her hand on her arm, Caller states, specifically, the rash, it looks like a huge bruise, around the size of a half dollar). Patient was asking how long does the symptoms last and will there be delayed presentation of symptoms. Caller states she is severely allergic to a lot of medications and she didn't want to have to go the emergency room, Caller states these events are making her hesitate to get the second shot and the caller also states she has read about delayed reactions and that makes her hesitant to get the second shot. Caller states for normalcy, and to have the ability to travel and not wear a mask. Caller states she is single and has been isolating, and she would like to interact with other people, for meet ups and group events. Outcome of the events Soreness in her arm was recovered on 16MAY2021, Bad migraine, after first vaccine, Tiredness was recovered on 17MAY2021, Swollen lymph nodes, Lymph node pain, under armpit and armpit was recovered on 19MAY2021, Soreness left arm injection site: described as red dot and small swelling at injection site, with warmth radiating from the site, after first vaccine, Red rash at injection site/red dot at the injection site, Small swelling at injection site, Warmth radiating from the site and She had an egg on her arm, that also had a red rash was Not recovered. Follow-up (21May2021): This is a follow up-spontaneous report from a contactable consumer. Information on lot/batch number was not available. Additional information has been requested.
44 2021-07-27 lymph node swelling The lymph nodes under my right arm (injection arm) became swollen and achy.; The lymph nodes under m... Read more
The lymph nodes under my right arm (injection arm) became swollen and achy.; The lymph nodes under my right arm (injection arm) became swollen and achy.; Lymph node pain had spread from just under my right arm pit up and over to part of my right breast towards the collar bone.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 27Apr2021 at 11:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and seasonal allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC), ibuprofen (MANUFACTURER UNKNOWN) and birth control (MANUFACTURER UNKNOWN), all taken for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 14:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 12:00, within 24 hours of the second injection, the patient experienced that the lymph nodes under her right arm (injection arm) became swollen and achy. The patient was unable to wear a bra due to the restrictive nature. Therapeutic measure were taken as a result of adverse events and included treatment with ibuprofen (ADVIL). When the ibuprofen wore off, the patient could feel the lymph node pain had spread from just under her right arm pit up and over to part of her right breast towards the collar bone. The lymph node pain began mid-Wednesday and lasted through Thursday. She did not have to take any ibuprofen for the pain on Friday. The clinical outcome of the events lymph nodes under right arm was swollen and achy and pain spread to right breast towards the collar bone were resolved on 29Apr2021. No follow-up attempts are needed. No further information is expected.
44 2021-07-28 lymph node swelling Very sore at injection site; very large red area at injection site; Very itchy area at injection sit... Read more
Very sore at injection site; very large red area at injection site; Very itchy area at injection site; Large knot at injection site; Swollen Lymph nodes; Severe headaches; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 29Apr2021 at 13:15 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received other unspecified medications within 2 weeks of vaccination. The patient previously received levofloxacin (LEVAQUIN) and cinnamon. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 14:00, the patient experienced very sore, very large red area and large knot at the injection site, swollen lymph nodes, severe headaches and severe fatigue for 4 days and very itchy area at injection site. The clinical outcome of events very sore, very large red area and large knot at the injection site, swollen lymph nodes, severe headaches and severe fatigue were resolved on 03May2021 while the event very itchy area at injection site was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
44 2021-07-28 lymph node swelling Headache; Fatigue; Fever; Swollen lymph nodes; Joint pain; Sore throat; Stomach pain; Loss of appeti... Read more
Headache; Fatigue; Fever; Swollen lymph nodes; Joint pain; Sore throat; Stomach pain; Loss of appetite; Chills; This is a spontaneous report from a contactable consumer. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 10:15 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar I disorder, depression, anxiety, meningioma brain tumor and migraine headache. The patient did not have any allergies to food, medications, or other products. Concomitant medications included escitalopram oxalate (LEXAPRO), lamotrigine (LAMICTAL), mefenamic acid (ADVIL), paracetamol (TYLENOL) and galcanezumab (EMGALITY) all from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 10:15 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021 at 20:00, the patient experienced headache, fatigue, fever, swollen lymph nodes, joint pain, sore throat, stomach pain, loss of appetite and chills. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, fatigue, fever, swollen lymph nodes, joint pain, sore throat, stomach pain, loss of appetite and chills were not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
44 2021-07-29 lymph node pain, lymph node swelling Swollen lymph nodes in right arm pit; Painful lymph nodes in right arm pit; Body aches; Chills; This... Read more
Swollen lymph nodes in right arm pit; Painful lymph nodes in right arm pit; Body aches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old-non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 02May2021 at 16:30(at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 06:00,the patient experienced swollen and painful lymph nodes in right arm pit and also experienced body aches and chills. The clinical outcome of the events swollen and painful lymph nodes in right arm pit, body aches and chills were recovering. No follow-up attempts are needed. No further information is expected.
44 2021-07-29 swelling Shingles; She can't even use one of her arms; Muscle aches; Nerve pain; Pain; Swollen; Low platelets... Read more
Shingles; She can't even use one of her arms; Muscle aches; Nerve pain; Pain; Swollen; Low platelets; Body aches; Chills; Got the second dose 2 weeks after the first dose; Could not function correctly; Headache; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, in Left Arm on 03May2021 at 11:30 (at the age of 44-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered in Left Arm on 19APr2021 at 11:30 as dose 1, single dose for COVID-19 immunization and experienced Could not function correctly, Headaches, Body aches, and chills. On 03May2021, the patient got the second dose 2 weeks after the first dose and experienced Could not function correctly pain , muscle aches, Body aches, swelling, Chills, Pain was all over the body on the right side. on 13May21 patient experienced Shingles, pain, Swollen, Low platelets caller stated that now she can't even use one of her arms. She had muscle aches and her nerves are acting up. She had nerve pain. patient visited physician office for adverse event. The patient underwent lab tests and procedures which included blood test: positive on 23May2021 Positive for shingles, blood test: decreased on 23May2021 low platelets. Therapeutic measures were taken as a result of all the events where she was given an antibiotic and nerve pain medicine. These were Diclofenac 75 mg, Prednisone 20mg, Valacyclovir 1gm and Gabapentin 300mg. The outcome for the events was not recovered. Information on the lot/batch number has been requested. Amendment: (06Jun2021) This follow-up report is being submitted to amend previously reported information: To recode LLT from Loss of personal independence in daily activities to LLT General malaise, to delete LLT off label use. Follow-up (21JUL2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
45 2020-12-31 anaphylactic reaction Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness a... Read more
Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness and swelling. Went to ER, treated with IV Benadryl, Epinephrine, Famotidine, Solumedrol, Klorcon M.
45 2020-12-31 peripheral swelling 12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 d... Read more
12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 days ago. The site on her left deltoid where she got the shot is warm and read. It also itches. No pain into the rest of left arm. no numbness of tingling at site or distally. no trouble breathing or tingling around mouth/throat. 01/01 - EE notes that her arm was very sore and she had a bad headache. As the days went on, it got redder, hotter, and more swollen. On 12/20, she began to feel bad. On 12/28 while at work, she heard that her supervisor was COVID (+). Throughout the day she felt worse and worse. Was seen at urgent care and COVID was negative. Prescribed Cephalxin and predinose 01/01 -- arm is much better today. Today it is still bruised. She thinks it was bruised previously but that the bruise could not be seen under the redness and swelling
45 2021-01-03 lymph node pain Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headach... Read more
Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headache is not uncommon for me but the extreme drowsiness is). I slept solid through the night (unusual) and the puppy woke me around 5am. (ususal) I felt that i had a heavy? head. My thoughts seemed clear but my head had a fullness to it. Its difficult to describe. I was not stuffy. I had trouble staying awake, to the point I was nodding off at times I should have been able to stay awake. I did not feel safe to work and felt obligated to call in. I slept solidly for the next 5 hours. Later in the day, my affected arm began to have pain radiate from the injection site to my wrist. (probably not unusual). 600mg of Ibuprofen did not seem to help much. By the time I went to bed last night (24+ hrs after receiving the vaccine) I noticed my axillary nymph nodes were extremely tender to the touch and remain so this morning. The pain in my arm still continues to radiate to my wrist but not as intense.
45 2021-01-04 peripheral swelling Full arm became swollen, red, warm to the touch, mimicking a cellulitis-looking infection. Redness ... Read more
Full arm became swollen, red, warm to the touch, mimicking a cellulitis-looking infection. Redness was spreading to left lateral neck and across upper chest. Took 50mg chewable Benadryl and 600mg motrin. All symptoms subsided approximately an hour later.
45 2021-01-04 swelling Notice yesterday, a large round red circle about 2 inches across, raised and swollen, hot to the tou... Read more
Notice yesterday, a large round red circle about 2 inches across, raised and swollen, hot to the touch, soreness and tender.
45 2021-01-05 lymph node swelling Significant left subclavicular lymphadenopathy; single area measured 10 mm on ultrasound.
45 2021-01-06 lymph node pain Patient presented to clinic stating that she had started to run a fever as high as 102 and pain to l... Read more
Patient presented to clinic stating that she had started to run a fever as high as 102 and pain to lymph nodes under left axilla and neck
45 2021-01-06 peripheral swelling, lymph node swelling Patient called, stating swelling of arm and lymph nodes within 24 hrs of injection and lump at sit... Read more
Patient called, stating swelling of arm and lymph nodes within 24 hrs of injection and lump at site. Applied ice and heat. States it is getting better but if "ball" does not get any better would like to be seen. Agreed with aptient
45 2021-01-06 peripheral swelling, lymph node swelling patient called stating she had swelling of arm with lymph nodes.
45 2021-01-07 lymph node swelling On 12-16-2020 I received my first Pfizer injection and 5 days after I experienced lymphadenopathy to... Read more
On 12-16-2020 I received my first Pfizer injection and 5 days after I experienced lymphadenopathy to my neck, left arm and under the arm and clavicle. My lymph nodes are swelling and I am concerned since I never had my lymph nodes swell up. On my second injection 01-06-2021, I continue with lymph node swelling and my symptoms do not seem to go away. I went to see my doctor, that said it was probably a reaction to the Pfizer injection and he is recommending that in February 2021, if I still have swelling to my lymph nodes then lab work will be performed.
45 2021-01-07 swelling face Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - a... Read more
Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; This is a spontaneous report from a contactable physician (patient herself). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration (arm left), on 19Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received facial filler Restylane, which was injected in Sep2019. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within two to four weeks prior to COVID vaccination. On 22Dec2020, approximately 3 days after vaccination, patient noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas. There was minimal erythema and tenderness only on palpation. The events resolved approximately 3-4 days later (unspecified date in Dec2020). The events did not require intervention/treatment. Outcome of the events was recovered. Information on the lot/batch number has been requested.
45 2021-01-08 lymph node swelling, lymph node pain Swollen tender lymphnodes l. Supraclavicular, L. Axillary, L. Cervical 1 day after 2nd vaccine. H... Read more
Swollen tender lymphnodes l. Supraclavicular, L. Axillary, L. Cervical 1 day after 2nd vaccine. Headache, chills, sore thrat, nasal congestion started mostly day after, headache day of both tbe first and second vaccine
45 2021-01-10 peripheral swelling Itching from shoulder to elbow within a few minutes of vaccine, took Benadryl within the hour. Swel... Read more
Itching from shoulder to elbow within a few minutes of vaccine, took Benadryl within the hour. Swelling and itching continued to get worse. Site was hot. Stared taking Zyrtec twice a day. Within 48 hours site was so swollen visible through clothes, like a plum under the skin and was hot, itching. 99.5 temp Added Pepcid on Sunday, Swelling started going down, better Monday morning.
45 2021-01-10 peripheral swelling Left nostril stopped up; Sinus pressure in head; Pressure in head; Burning sensation in both arms an... Read more
Left nostril stopped up; Sinus pressure in head; Pressure in head; Burning sensation in both arms and in her left knee/both of her thighs swollen, burning and itching on both knees; Hives on both arms and left knee; both of her thighs swollen, burning and itching on both knees; Burning and itching on both knees; neck feels like someone is sitting on the back of it/Left side neck pressure and throbbing; Left side neck pressure and throbbing; Lower back spasms; This is a spontaneous report received from a contactable consumer. A 45-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, in Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the vaccine in Dec2020 (reported as "Thursday"). She began experiencing symptoms on Friday (as reported). Her left nostril stopped up and had sinus pressure in her head. On Saturday and Sunday (as reported), her left nostril was not stopped up but still had pressure in her head. On Monday (as reported), she began to feel burning sensation in both arms and in her left knee. When the patient was de-gowning PPE while at work, she found hives on both arms and left knee. She took BENADRYL and applied cold compress to site. Later Monday (as reported), she woke up to both of her thighs swollen, burning and itching on both knees. Her neck feels like someone is sitting on the back of it. She experienced left side neck pressure and throbbing and lower back spasms. The patient would like to know if these symptoms have been reported and what should she do. The outcome of the event "left nostril stopped up" was recovered on an unspecified date; "sinus pressure in head" and "pressure in head" was not recovered; and the outcome of the remaining events was unknown. Information on lot/batch number for the product has been requested.
45 2021-01-10 swelling Redness, warmth and swelling 2 days post injection. Seen in ED and prescribed doxycycline and improv... Read more
Redness, warmth and swelling 2 days post injection. Seen in ED and prescribed doxycycline and improving.
45 2021-01-11 lymph node pain, peripheral swelling, lymph node swelling Received second dose of COVID vaccine on 1/6/21. On 1/9/21, expericenced left axillary swollen lymph... Read more
Received second dose of COVID vaccine on 1/6/21. On 1/9/21, expericenced left axillary swollen lymph nodes/ tenderness to left axillary region. Received vaccine in left arm. Spoke with employee via Employee Phone hotline and was instructed to fill out safe watch report. Employee took Ibuprofen for discomfort and performed massage to lymph area. Left arm and axillary area swollen on 1/12/21 during EH visit.
45 2021-01-12 swelling 23 hrs post injection I woke up with angioedema in my lip. Approx. 1.5 weeks later a second occurren... Read more
23 hrs post injection I woke up with angioedema in my lip. Approx. 1.5 weeks later a second occurrence of angioedema in lips. A 3rd occurrence took place 1/12/2021 and this occurrence was most severe of the 3 occurrences so far.
45 2021-01-12 lymph node pain, lymph node swelling on 1/11/21, developed swollen lymph node on right clavicle area- pea sized tender to touch, sore wi... Read more
on 1/11/21, developed swollen lymph node on right clavicle area- pea sized tender to touch, sore with head movement to the left.
45 2021-01-12 lymph node pain, lymph node swelling Sore lymph nodes underarm left arm Very sore and swollen lymph nodes above the left collarbone
45 2021-01-12 swelling Rash all over body with swelling and blisters
45 2021-01-12 swelling At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck.... Read more
At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck. The next day this continued with a fever of 99-100, malaise, and chest discomfort. At the 48th hour, today?s date, fever still present, body aches are improved, but my head feels hot and now with a stiff neck. I feel very tired and mental status seems ?foggy?
45 2021-01-13 lymph node swelling On 1/13/21 extreme fatigue- sleeping 4 to 5 hours at a time, swollen gland on right side 1/14/21 nau... Read more
On 1/13/21 extreme fatigue- sleeping 4 to 5 hours at a time, swollen gland on right side 1/14/21 nausea, headache, dizziness, fever-100.7, muscle ache, swollen gland still
45 2021-01-13 swelling face shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nau... Read more
shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nausea, skin burning sensation, facial swelling
45 2021-01-14 lymph node swelling On Jan 10, 2021 I received the second dose of the Pfizer vaccine into my left upper arm. The followi... Read more
On Jan 10, 2021 I received the second dose of the Pfizer vaccine into my left upper arm. The following day I woke up with my axillary lymph nodes swollen and extremely painful. I addition I did have headache and fatigue. 90% of swelling has decreased on post day 3. Today at this time I am still having altered sensation and discomfort in left arm.
45 2021-01-14 lymph node swelling Received vaccine 1/13/21 at 10:30 am. Felt fine all day. Woke up next day 1/14/21 at 5 AM with feve... Read more
Received vaccine 1/13/21 at 10:30 am. Felt fine all day. Woke up next day 1/14/21 at 5 AM with fever 101.0, body aches, dizziness, fatigue enlarged lymph node at left axilla, same side as shot, mild nausea, and a sore left arm. Felt sick for about 12 hours with these symptoms, fever resolved slowly with ibuprofen. Symptoms mostly resolved in 24 hours, except I still have an enlarged lymph node - left axilla with throbbing pain. No fever.
45 2021-01-14 lymph node swelling swollen lymph nodes in arm pits and neck area, extreme fatigue
45 2021-01-14 peripheral swelling Severe pain in both arms few hrs after injection given in left arm. Now, right arm swollen compared ... Read more
Severe pain in both arms few hrs after injection given in left arm. Now, right arm swollen compared to left. Carpal tunnel pain at wrist. Worse at night and when holding arm in downward position. Have not had carpal tunnel before. No injury to arms. No recent trauma or heavy lifting
45 2021-01-17 anaphylactic reaction Itching, rash, hives, difficulty breathing, difficulty swallowing, anaphylactic response. Treatment... Read more
Itching, rash, hives, difficulty breathing, difficulty swallowing, anaphylactic response. Treatment: epipen, IM Benedryl shot x2, ambulance transport to ER at Hospital for monitoring Outcome- deduced symptoms and eventual absence of symptoms 24 hours later
45 2021-01-17 axillary mass, lymph node swelling nausea, lump/swelling under left arm/breast, headache severe, body aches at the slightest touch, pai... Read more
nausea, lump/swelling under left arm/breast, headache severe, body aches at the slightest touch, painful eyes from 1/15-1/17 w/ headache severe, loss of appetite, nausea lasting from 1/15-present day.
45 2021-01-17 lymph node swelling Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) af... Read more
Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) after injection and spreading to entire face. Symptoms resolved 4 hours later. Intermittent palpitations starting during this time which have not resolved to this day. Twelve hours (time 0330) after injection experienced common reported adverse effects (arthralgia, myalgia, headache, chills, severe neck pain, headache) in addition to unexpected supraclavicular lymph node swelling on injection side. Consistent fever of 102 degree fahrenheit starting 12 hours (time 0330) post injection and lasting for 20 hours, after which remained 99-100 for an additional 8 hours. Started to take Tylenol 15 hours after vaccine dose (0630). Also have continued to have dull headaches since vaccine dose.
45 2021-01-18 axillary mass, lymph node swelling Left arm was sore all day Sunday and Monday. Monday night I noticed a lump in my armpit. It is painf... Read more
Left arm was sore all day Sunday and Monday. Monday night I noticed a lump in my armpit. It is painful and still there.
45 2021-01-18 lymph node pain, lymph node swelling left subscapular lymphnode swelling with tenderness; left subscapular lymphnode swelling with tender... Read more
left subscapular lymphnode swelling with tenderness; left subscapular lymphnode swelling with tenderness; This is a spontaneous report from a contactable nurse. A 45-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration from 16Dec2020 11:15 to 16Dec2020 11:15 at a single dose for covid-19 immunization. Medical history included seasonal allergy and Sulfa drugs Allergies. Concomitant medication included minerals nos, vitamins nos (CENTRUM A to Z) and naproxen sodium (ALEVE). The patient had left subscapular lymph node swelling with tenderness on 01Jan2021. The outcome of the events was recovering.
45 2021-01-18 peripheral swelling Night of 2nd dose had chills/body aches. Developed diarrhea next day. Arm became swollen and sore,... Read more
Night of 2nd dose had chills/body aches. Developed diarrhea next day. Arm became swollen and sore, red and itchy. Continued to get progressively more red, sore, itchy and swollen. On day 5 post vaccination, seeing by primary care doctor and diagnosed with cellulitis. Placed on antibiotics.
45 2021-01-18 peripheral swelling Sleepiness; pain at site for >24hrs less than 48hrs; itching on arm below injection site; headache; ... Read more
Sleepiness; pain at site for >24hrs less than 48hrs; itching on arm below injection site; headache; petichiae on site arm below injection site; sneezing; vivid dreams; swelling in legs; lower appetite; thirsty; more frequently urination with larger amounts; more frequently urination with larger amounts; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 04Jan2021 at 15:45 on arm at single dose for COVID-19 immunization. Medical history included Chronic sinusitis and had known allergies with Gluten and Sulfa. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took tizanidine hydrochloride (TANIN, reported as tanins) and had known allergy. The patient experienced sleepiness, pain at site for more than 24hours less than 48hours, itching on arm below injection site, headache, petichiae on site arm below injection site, sneezing, vivid dreams, swelling in legs, lower appetite, thirsty, more frequently urination with larger amounts on 04Jan2021 at 19:00. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No. Information on the lot/batch number has been requested.
45 2021-01-19 lymph node swelling 1st dose - feverish, all over body ache, HA, run down/ tired/ fatigue. 2nd dose - body ache and HA (... Read more
1st dose - feverish, all over body ache, HA, run down/ tired/ fatigue. 2nd dose - body ache and HA (both not as severe as 1st dose), two days post injection = painful and swollen right axilla lymphadenopathy and right breast pain...used right deltoid for injection site. Also, noted fatigue and chills w/o known fever.
45 2021-01-19 swelling face Swelling of face and pain with stiffness of neck muscles
45 2021-01-20 lymph node pain, lymph node swelling Lymph node in right arm pit extremely swollen and painful for 2 full days. Still slightly swollen at... Read more
Lymph node in right arm pit extremely swollen and painful for 2 full days. Still slightly swollen at day 3.
45 2021-01-20 lymph node swelling chest and axillary adenopathy; Tender clavicular; This is a spontaneous report from contactable heal... Read more
chest and axillary adenopathy; Tender clavicular; This is a spontaneous report from contactable healthcare professional (patient). This 45-year-old female patient (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot 9231) intramuscular, in left arm, on 30Dec2020 at 17:45, for COVID-19 immunization. No other vaccine was given in 4 weeks. Medical history included allergy to sulfamethoxazole (BACTRIM). The patient had no COVID19 prior vaccination and was not tested after vaccination. Concomitant medication included ethinylestradiol, levonorgestrel (DAYSEE) 0.15-0.03 (unspecified unit and frequency). On 02Jan2021 the patient experienced chest and axillary adenopathy and tender clavicular. No treatment was given. The events had not yet resolved at the time of report.
45 2021-01-20 lymph node swelling Cough, asthma, headache, fatigue, fevers, muscle and joint pain, nausea, chills, swollen lymph node
45 2021-01-21 lymph node pain severe pain at injection site as well as swelling and severe pain in axillary lymph nodes of the le... Read more
severe pain at injection site as well as swelling and severe pain in axillary lymph nodes of the left arm where the injection was received.
45 2021-01-21 lymph node swelling Vaccine received around 8am, 1/18/21. Normal day, no events, developed a little soreness at injectio... Read more
Vaccine received around 8am, 1/18/21. Normal day, no events, developed a little soreness at injection site. Woke up around 1:30am on 1/19/21 and could not go back to sleep with overall malaise and pain in my right axilla (ipsilateral to vaccine); upon palpation of this area, I could feel enlarged lymph nodes, very sensitive to the touch (never had this from a vaccine, and I take usual flu shots and others occasionally recommended). Malaise slowly went away during the day, pain in right axilla persisted, although not as bothersome for about 2 days. On 1/19/21, I also had myalgia, which were still present on 1/20/19, but slowly subsided. Today 1/22 the enlarged right axillary adenopathy is still palpable, mild to no pain.. No additional symptoms.
45 2021-01-21 peripheral swelling, lymph node swelling Swollen and sore arm (same arm injection given in) swollen lymph nodes in neck (both sides) and R ar... Read more
Swollen and sore arm (same arm injection given in) swollen lymph nodes in neck (both sides) and R armpit
45 2021-01-23 swelling face My right arm broke out in hives a few hours following the injection, and then my left arm a few hour... Read more
My right arm broke out in hives a few hours following the injection, and then my left arm a few hours later. The next morning my right ear swelled , was red and covered in hives and very painful. It continued to swell over next few days, very painful. I was feeling drained and had gastrointestinal symptoms for days and this morning woke up with my face swollen and another rash and hives on my face. I had a little trouble breathing as well and went to an Urgent Care. The doctor believes I had an allergic reaction to the vaccine and administered a steroid injection and prescribed steroids and antihistamines.
45 2021-01-23 white blood cell count increased Diarrhea temp fatigue muscle aches no appetite. seen dr Blood tests done. White an... Read more
Diarrhea temp fatigue muscle aches no appetite. seen dr Blood tests done. White and red blood cells elevated. Dx with reaction to vaccination.
45 2021-01-24 lymph node swelling, lymph node swelling, peripheral swelling She had her second vaccine on 1/20/21 in her right arm. She noticed chills but no fever. She had bod... Read more
She had her second vaccine on 1/20/21 in her right arm. She noticed chills but no fever. She had body aches. Swelling in arm pits. Tightness in right chest and back. She did a lot of driving and arm went numb, but gone now she is home. Swelling in arm still there.
45 2021-01-24 swelling face, swelling Soreness in her Left arm on 1/18. Congestion at 2am on 1/19 then when she went into work on 1/19 she... Read more
Soreness in her Left arm on 1/18. Congestion at 2am on 1/19 then when she went into work on 1/19 she lost her voice and she had face and neck/throat swelling
45 2021-01-24 swelling, lymph node swelling office pocus revealed a 2.5 cm lymph node; 36 hours after second shot I developed marked swelling an... Read more
office pocus revealed a 2.5 cm lymph node; 36 hours after second shot I developed marked swelling and pain in my left axilla./Swelling persists into day 3.; 36 hours after second shot I developed marked swelling and pain in my left axilla./Swelling persists into day 3.; This is a spontaneous report from a contactable physician reported for herself. This 45-year-old female patient started the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EL1284), via an unspecified route of administration at single dose on 09Jan2021 14:30 for covid-19 immunisation. Medical history included anxiety. Concomitant medication included ethinylestradiol, norethisterone acetate (MICROGESTIN), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), montelukast sodium (SINGULAIR), colecalciferol (VITAMIN D [COLECALCIFEROL]), escitalopram oxalate (LEXAPRO). Previously the patient received the first dose of BNT162B2 (Lot # EK5730), in the left arm on 19Dec2020 02:15 PM for covid-19 immunisation. On 11Jan2021 02:30, the patient experienced that office POCUS revealed a 2.5 cm lymph node, 36 hours after second shot I developed marked swelling and pain in my left axilla. Swelling persists into day 3. The outcome of the events was recovering. The patient underwent lab tests and procedures which included ultrasound scan: 2.5 cm lymph node on 11Jan2021 (Office POCUS revealed a 2.5 cm lymph node). Therapeutic measures were taken as a result of the events included Naproxen. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination.
45 2021-01-24 swelling, swelling face Left was sore on 1/18. 1/19 Woke up very congested. 1/19 went into work, she lost her voice and eye... Read more
Left was sore on 1/18. 1/19 Woke up very congested. 1/19 went into work, she lost her voice and eyes, face and neck swollen- felt like her throat was swelling
45 2021-01-26 lymph node swelling, lymph node pain On 1/17 awoke with sore neck and swollen and tender lymph nodes in left neck/shoulder/arm. Evaluated... Read more
On 1/17 awoke with sore neck and swollen and tender lymph nodes in left neck/shoulder/arm. Evaluated at hospital occupational health and received a prescription for steroids.
45 2021-01-26 lymph node swelling lymph node swelling in axillary area on the injection side; lymph node swelling in axillary area on ... Read more
lymph node swelling in axillary area on the injection side; lymph node swelling in axillary area on the injection side and it's painful; This is a spontaneous report from a contactable nurse and other hcp (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number: EL1283, expiry date: unknown), via an unspecified route of administration on 11Jan2021 09:00 at single dose (left deltoid) for COVID-19 immunization. There were no medical history and concomitant medications. On 12Jan2021, patient had lymph node swelling on the same arm as the injection site. It got worse on the 13th. She described her experience as uncomfortable. She was asking how long it is expected to last. It was further reported that the patient received first Covid-19 vaccine on 11Jan2021 and is doing well, but had lymph node swelling in axillary area on the injection side and it's painful on 12Jan2021. She wanted to know how long it will be like that and if it doesn't go away when should she seek medical attention. Received the vaccine on the 11th and a couple days later had the lymph node swelling. She then clarified lymph node swelling started the 12th. Mentioned it got worse yesterday and it's staying about the same today with the swelling and is very uncomfortable (Jan2021) and is persisting. Causality not provided. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in the past. Vaccination Facility Type was Clinic. The outcome of the events was not recovered. Events reported as medically significant.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events swollen lymph nodes and lymph node pain. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-01-26 lymph node swelling Extreme headache, 101 temp. Reactive lymphadenopathy at clavicle on side of injection.
45 2021-01-27 lymph node swelling 5 days after the first shot(12/24/2020), I started feeling extremely fatigued. I had axilla lymphad... Read more
5 days after the first shot(12/24/2020), I started feeling extremely fatigued. I had axilla lymphadenopathy, dizziness, nausea, joint pain, muscle pain and periods of tachycardia when standing. This lasted for 7 days. The lymphadenopathy was diagnosed in a routine mammogram/ultrasound screening 9 days after the vaccine. I finally started feeling better the week I was scheduled to receive my second shot. I got my second shot on 1/14/2021. Within 12 hours, I had a 101 fever and muscle aches. I also had axilla lymphadenopathy. Within 3 days, I was feeling better, however about 8 days post vaccine, I started to experience bouts of tachycardia and dizziness again. As time progresses, these symptoms are slowly improving.
45 2021-01-27 swelling face Received the second vaccine yesterday 1/27/2021 around 11am. About an hour later started to get hive... Read more
Received the second vaccine yesterday 1/27/2021 around 11am. About an hour later started to get hives and took a Claritin. Was at home later in the evening around 5pm and started to have lip/jaw swelling and throat tightening. Called an ambulance and they gave her EPI pen and took over treatment. Ended up getting discharged around 11-12pm last night and told to take prednisone and Benadryl. Around 5am today 1/28 had swelling in tongue and bottom lip swelling. Went back to emergency room and they did similar treatment. Is planning to follow up with her doctor and will be on her prescribed medications for a few days.
45 2021-01-27 swelling face 1/6/21 Received Pfizer COVID vaccine part 2. 1/12/21 ... Read more
1/6/21 Received Pfizer COVID vaccine part 2. 1/12/21 Went to urgent care for mild swelling and numbness on left side of face, scalp, ear. Also very dry flaky skin. Given desnoide cream, and instructed to take Claritin 1/13/21-1/15/21 Took Claritin, and all symptoms resolved except for dry skin 1/16/21-1/17/21 Did NOT take Claritin 1/18/21 Mild facial numbness, on left. Took Zyrtec-D, symptoms improved 1/19/21 No apparent numbness. Took Claritin 1/20/21 Possibly hint of numbness. Extremely dry skin and scalp. Took Claritin. Used desonide. Only skin around eyes slightly swollen. 1/21/21 Mild-mod numbness on left side of face. Extremely dry skin and scalp. Face feels warm. Took Claritin
45 2021-01-28 herpes virus infection Reactivating of herpes virus; This is a spontaneous report from a contactable Pharmacist. This Pharm... Read more
Reactivating of herpes virus; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for similar events for two patients. This is the second of two reports. A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration on left arm on 13Jan2021 05:30 at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility type vaccine was in nursing home/senior living facility. No other vaccine in four weeks. No COVID prior vaccination. The patient had no known allergies. The patient medical history was not reported. Concomitant medications (medications in two weeks) included calcium and colecalciferol (VIT D3). The patient experienced reactivating of herpes virus on 15Jan2021 05:30. No treatment was administered for the event. The patient was not COVID tested post vaccination. The outcome of the event was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021032647 same report/drug/event, different patient
45 2021-01-29 peripheral swelling Swelling and soreness pain under left armpit front lower
45 2021-01-31 lymph node swelling Reported feeling hot flashes, nosebleed, chills, lifht headedness, nausea, fatigue, body aches, swol... Read more
Reported feeling hot flashes, nosebleed, chills, lifht headedness, nausea, fatigue, body aches, swollen lymph under jaw on neck.
45 2021-01-31 peripheral swelling Patient developed fever of 103 and body aches the evening of her vaccination, and continued with fev... Read more
Patient developed fever of 103 and body aches the evening of her vaccination, and continued with fever of 101-103 for the next two days. She experienced headache and nausea for the next week. On 1/22/21 she developed pain and swelling in the right middle finger at the MCP and PIP joints, and then on 1/24/21 developed pain and swelling in the L fourth finger MCP and PIP joints. She also started her period after the vaccine was given and has continued to have daily vaginal bleeding since. Her hand pain is improved slightly as of today.
45 2021-01-31 swelling, peripheral swelling nausea; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling an... Read more
nausea; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; headache; body aches at the slightest touch; fever; loss of appetite lasting 4 days; left upper arm/underarm/breast swelling and pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiration date not provided), intramuscular in the left arm on 14Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and hypothyroidism. The patient is not pregnant. The patient has no know allergies. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and no other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Jan2021 02:45, the patient experienced nausea, left upper arm/underarm/breast swelling and pain, headache nothing would take away, body aches at the slightest touch, fever, loss of appetite lasting 4 days and still with nausea, loss of appetite and headache. Treatment was not provided in response to the events. The outcome of the events was recovered with sequelae on an unspecified date in Jan2021. The patient has not been tested for COVID post vaccination.
45 2021-02-01 swollen extremities, lymph node swelling 1ST INJECTION WAS 1/28/21 THE EVENING AFTER 1ST INJECTION (1/29/21).. FEVER 102 MUSCLE AND JOINT ACH... Read more
1ST INJECTION WAS 1/28/21 THE EVENING AFTER 1ST INJECTION (1/29/21).. FEVER 102 MUSCLE AND JOINT ACHES, HEADACHE AND SWOLLEN AXILLARY NODES IN LEFT ARM LASTING ABOUT 24-36 HOURS. 4 200ML ADVIL TAKEN SWOLLEN NODES REMAINED SUNDAY MORNING AND I WOKE WITH LEFT SIDE OF MY FACE NUMB BUT FUNCTIONING WHICH CONTINUED FOR ABOUT 48 HOURS. TODAY (2/2/21) IS DAY 5 POST INJECTION, SWOLLEN NODES REMAIN AND PINS AND NEEDLES FEELING ON LEFT SIDE OF FACE
45 2021-02-02 lymph node swelling Swollen lymph node 1 week after vaccine
45 2021-02-02 lymph node swelling Injection Site Pain, Congestion, Fatigue, Swollen Lymph nodes, Nausea, & Headache
45 2021-02-02 peripheral swelling Extreme swelling, redness, and soreness in left arm, can barely lift.
45 2021-02-02 swelling face Mild allergic reaction (tingling in mouth, splotchy red chest, itchy eyes) approximately 5-10 minute... Read more
Mild allergic reaction (tingling in mouth, splotchy red chest, itchy eyes) approximately 5-10 minutes after receiving the vaccine; itchy eyes and puffiness in face on and off from time of vaccine to present (7 days later); vaccine and/or subsequent mild allergic reaction triggered Functional Neurological Disorder symptoms (involuntary muscle activations in legs, face and neck, dystonic posturing of feet)
45 2021-02-03 lymph node swelling, lymph node pain Approximately 18 hours post injection I began running a fever with severe body aches and headache. 2... Read more
Approximately 18 hours post injection I began running a fever with severe body aches and headache. 24 hours after onset of initial symptoms, I developed diarrhea. 72 hours after injection, I noted a large painful lymph node in the axilla of the injection side. Fever and malaise continue in addition to cough and chest tightness
45 2021-02-03 lymph node swelling lymph node swelling; This is a spontaneous report from a contactable other healthcare professional (... Read more
lymph node swelling; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ek9231, expiry date unknown), intramuscular at the right arm on 05Jan2021, 15:00 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included atenolol and ibuprofen (MOTRIN). The patient previously received first dose of BNT162B2 for COVID-19 immunization on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. Patient was not pregnant at the time of vaccination. The patient experienced lymph node swelling on 07Jan2021. The event resulted to physician office visit (Doctor or other healthcare professional office/clinic visit). No treatment was received for the event. The outcome of the event was recovered on Jan2021. The event was non-serious.
45 2021-02-05 lymph node swelling L arm pain. L sided lymphadenopathy anterior cervical, supraclavicular
45 2021-02-05 lymph node swelling Left axilla pain, feeling of left axilla swelling Fever General malaise
45 2021-02-07 lymph node pain, lymph node swelling fatigue; chills; fever (about 99-100F); the site of injection is sore; a moving painful lump near le... Read more
fatigue; chills; fever (about 99-100F); the site of injection is sore; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; This is a spontaneous report from a contactable other health professional reported for herself. This 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9031) via an unspecified route of administration on 19Jan2021 at 09:15 AM at single dose in left arm for COVID-19 immunization. The patient is not pregnant. Medical history and concomitant medications were reported as none. Allergies to medications, food, or other products was reported as none. The patient previously received the first dose of BNT162B2 (Lot number EH9899) on 30Dec2020 at 11:15 AM at single dose in left arm for COVID-19 immunisation and had no symptoms; Influenza vaccine on 10Dec2020 for immunization. The patient experienced fatigue, chills followed by fever (about 99-100F) lasted for about one and half days. The site of injection is sore even after 3 days. The patient observed a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch. The events onset date was reported as 21Jan2021. The events were reported as non-serious. The patient was not diagnosed with COVID-19 Prior to vaccination and not tested for COVID-19 since the vaccination. The patient received no treatment. The outcome of the events was not resolved.
45 2021-02-07 lymph node swelling Pfizer-BioNTech COVID19 Vaccine Severe symptoms following day: injection site pain, fatigue, headac... Read more
Pfizer-BioNTech COVID19 Vaccine Severe symptoms following day: injection site pain, fatigue, headache, whole body muscle pain, chills, nausea, malaise. 2nd and 3rd day symptoms: left underarm swollen lymph nodes, injection site pain, headache, tiredness, slight nausea, slight muscle pain. Missed work 1 day, unable to drive 2 days.
45 2021-02-07 lymph node swelling Swollen axillary lymph on left arm; low grade fever (daily average: 97.3. For 24 hours following inj... Read more
Swollen axillary lymph on left arm; low grade fever (daily average: 97.3. For 24 hours following injection was 99.8); Significant lethargy; "railroad spike" headaches that correlate with the right parietal and right occipital lasting approx 30 hours; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK4176), via an unspecified route of administration in the left arm on 20Jan2021 at 07:00 at a single dose in the hospital for covid-19 immunization. Medical history included hyperlipidaemia, depressive disorder, chronic anxiety disorder, hypertensive, allergies to PCN (anaphylactic) and sulfa (allergic). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]), escitalopram oxalate (LEXAPRO), losartan, and Mg/Ca supplement. The patient experienced swollen axillary lymph on left arm, "railroad spike" headaches that correlate with the right parietal and right occipital lasting approx 30 hours, low grade fever (daily average: 97.3. For 24 hours following injection was 99.8), and significant lethargy on an unspecified date. The patient did not receive treatment for the events. Outcome of the event headache was recovered and for other events was reported as recovering.
45 2021-02-07 lymph node swelling Day1: swelling in axillary and clavicle lymph nodes Day 2: lymph nodes near breast tender and swoll... Read more
Day1: swelling in axillary and clavicle lymph nodes Day 2: lymph nodes near breast tender and swollen Day 3: brain fog, feeling jittery, chills, fever 100.2
45 2021-02-07 peripheral swelling COVID Arm - raised patch 3 inches in diameter
45 2021-02-07 swelling face swelling on the left side of her jaw and throat began to swell/swelling on left side of face and thr... Read more
swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat; Tingling; swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw; felt a funny sensation in her throat and face/still not feeling herself; soreness; left arm was sore; throat still feels funny; feels scratchy; feeling fatigued; This is a spontaneous report from a contactable consumer reporting for herself. A 45-years-old female patient started to receive bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EH9899, exp date 31Mar2021), via an unspecified route of administration in the left arm, on 15Jan2021 at 14:30, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced left arm was sore on 16Jan2021 with outcome of recovered, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat on 18Jan2021 with outcome of recovering, tingling on 18Jan2021 with outcome of recovering, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw on 18Jan2021 with outcome of recovering, felt a funny sensation in her throat and face/still not feeling herself on 18Jan2021 with outcome of not recovered, feeling fatigued in Jan2021 with outcome of not recovered, soreness on 16Jan2021 with outcome of recovering, throat still feels funny; feels scratchy on Jan2021 with outcome of not recovered. The patient visited the emergency room for left arm was sore, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat, tingling, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw. The patient was treated in the emergency room with prednisone, Benadryl and acid medicine for her stomach.
45 2021-02-07 swelling Severe headache; Fevers; nausea; body aches; severe prolonged fatigue; swollen underarms; This is a ... Read more
Severe headache; Fevers; nausea; body aches; severe prolonged fatigue; swollen underarms; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the second dose of BNT162B2 (lot number: EL1283 and expiry date was unknown), via an unspecified route of administration in the left arm on 10Jan2021 08:30 at single dose for Covid-19 immunization. The patient is not pregnant. Medical history included asthma. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (lot no. and expiry date were unknown) in the left arm on 21Dec2020 12:00 PM for Covid-19 immunization. The most recent COVID-19 vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor any other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10Jan2021 at 08:30 AM, the patient experienced severe headache for 12 days, nausea, body aches, severe prolonged fatigue, swollen underarms, fever for 7 days. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included fluids and analgesics round the clock. The patient underwent laboratory test which included Covsars2 swab/nasal swab on 13Jan2021 and the result was negative. The events recovered with sequelae.
45 2021-02-09 lymph node swelling Swollen lymph node
45 2021-02-09 lymph node swelling Headache; Myalgia; Chills; Lymphadenopathy; Brain fog; This is a spontaneous report from a contactab... Read more
Headache; Myalgia; Chills; Lymphadenopathy; Brain fog; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ek9231) via intramuscular in left arm on 02Jan2021 18:00 at single dose for COVID 19 immunization. The patient received the vaccine in hospital. Medical history included asthma, migraine. Known allergies included Latex allergy. Concomitant medication included oral contraceptive pill (OCP), ergocalciferol (VIT D), melatonin, ubidecarenone (COQ10) and fexofenadine hydrochloride (ALLEGRA). No other vaccine was received in four weeks. The patient didn't have COVID prior vaccination. The patient experienced headache, brain fog, myalgia, chills, lymphadenopathy on 03Jan2021. Therapeutic measures were taken as a result of events including ibuprofen (MOTRIN). The events did not require Emergency Room Visit or Physician Office Visit. No COVID was test post vaccination. The outcome of events was recovered in Jan2021.
45 2021-02-09 lymph node swelling Severe swollen lymph node left axilla/ Injection site left arm; This is a spontaneous report from a ... Read more
Severe swollen lymph node left axilla/ Injection site left arm; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El9262), via an unspecified route of administration on 22Jan2021 13:00 at a single dose on left arm for COVID-19 immunization. Medical history included Hypothyroidism, depression, vit D def., penicillin allergy and COVID-19. Concomitant medication included liothyronine sodium (CYTOMEL), levothyroxine sodium (SYNTHROID), celecoxib (CELEXA [CELECOXIB]), omega-3-acid ethyl ester (LOVAZA), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), and an unspecified vitamin. The patient experienced Severe swollen lymph node left axilla/ Injection site left arm on 22Jan2021 18:00. No treatment received for the event. The outcome of the event was recovering. The patient was not pregnant. No other vaccine in four weeks. Not COVID tested post vaccination.
45 2021-02-09 swelling I received Pfizer dose #1 on 1/13/21 with no AE. I received Pfizer dose #2 on Mon 2/1/21. On Wed ... Read more
I received Pfizer dose #1 on 1/13/21 with no AE. I received Pfizer dose #2 on Mon 2/1/21. On Wed 2/3/21, I awoke with hives on my neck and chest, I took a Clarinex. The hives progressed t/o the day. I took a Benadryl that evening. I had difficulty sleeping d/t the burning and itching. I took another Benadryl at 0130 on 2/4/21. By 0930 on 2/4/21 my entire torso and scalp was inflamed. My shoulders were swollen. I had difficulty swallowing. I had a sudden "brain fog" with difficulty speaking and a major headache. I took another Benadryl. I then slept for 21 hours with a half hour awake period for lunch and scheduled Benadryl every 6 hours. My PCP recommended Pepcid 20 mg po BID x 5 days so I started that as well, and I took tylenol for the headache. The next day my rash had improved. I was tired but not extremely fatigued like the day prior. I gradually felt better t/o the day. Saturday 2/6/21, I awoke with resolution of all s/s.
45 2021-02-10 c-reactive protein increased Severe fatigue, muscle aches, joint pains in shoulders and hips progressing to the point of difficul... Read more
Severe fatigue, muscle aches, joint pains in shoulders and hips progressing to the point of difficulty getting up from a sitting position. Missed work on week 3. Worsened each week until that point. Improves with rest but worse after on feet more. Extreme exhaustion. Some chest pressure started on week 2
45 2021-02-10 lymph node pain, lymph node swelling Left arm felt heavy a couple hours after second COVID vaccine. By evening she had tenderness to left... Read more
Left arm felt heavy a couple hours after second COVID vaccine. By evening she had tenderness to left axilla. In am on 2/10/21 she could not move left arm due to swelling and pain in lymph nodes. Woke up 2/11/21 and still couldn't move arm due to discomfort. Also developed a runny nose, slight upper abdominal pain, and slight headache.
45 2021-02-10 swelling face Tingling of tongue and lips; Tingling of tongue and lips; Swelling of cheeks; face turned flush; ras... Read more
Tingling of tongue and lips; Tingling of tongue and lips; Swelling of cheeks; face turned flush; rash on neck and upper chest area; This is a spontaneous report from a contactable consumer (patient) This 45-years old no pregnant female consumer received the firs dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EL3247 on 21Jan2021 04:45 at left arm at single dose for Covid-19 immunization. Medical history included:allergies to medications, food or other products and high blood pressure .The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received any other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered:Other.On 21Jan2021 17:00 the patient developed Tingling of tongue and lips, Swelling of cheeks, face turned flush, rash on neck and upper chest area.The patient was treated with Benadryl. Events was reported as non serious .Outcome of the events was recovering. No Prior to vaccination, was the patient diagnosed with COVID-19. No Since the vaccination, has the patient been tested for COVID-19.
45 2021-02-11 peripheral swelling Red, Swollen Arm. Muscle aches, flu like symptoms, joint pain. Has a scar on her arm that is typical... Read more
Red, Swollen Arm. Muscle aches, flu like symptoms, joint pain. Has a scar on her arm that is typically flat, but is raised as a result of inflammation
45 2021-02-15 lymph node swelling I have a large, swollen, painful area under my left arm, in the armpit, that has been diagnosed as c... Read more
I have a large, swollen, painful area under my left arm, in the armpit, that has been diagnosed as cellulitis. I am on a 10 day course of antibiotics. My left arm, where the dose was given, is red, slightly swollen, and sore to the touch. My doctor has advised to continue to take ibuprofen and to treat with ice packs. I would expect it to resolve in ten days when the antibiotics are completed.
45 2021-02-15 lymph node swelling Swollen lymph nodes under arms
45 2021-02-18 lymph node swelling Fever, chills, loss of appetite, lethargy, headache, body ache, swollen lymph nodes (right underarm)... Read more
Fever, chills, loss of appetite, lethargy, headache, body ache, swollen lymph nodes (right underarm), loss of appetite, rash
45 2021-02-18 lymph node swelling Enlarged painful lymph nodes near collarbone in the crevice of neck, treated with warm compress, ace... Read more
Enlarged painful lymph nodes near collarbone in the crevice of neck, treated with warm compress, acetametaphine, and 14 days of doxycycline
45 2021-02-19 anaphylactic reaction While sitting in the waiting area I began to feel itchy. it was around 7:50am. I quickly took 2 chew... Read more
While sitting in the waiting area I began to feel itchy. it was around 7:50am. I quickly took 2 chewable (12.5mg each) benadryl tablets. after about 5 min. i felt stable enough to leave. on the way home I started to feel the itching intensify and I felt very warm. I had welts forming and hives appeared all over. As I pulled into my driveway( 7 min drive from vaccination site) I felt my lips and eyelids swell, and my throat felt tingly. I took another 2 chewable benadryls. (12.5mg each). I immediately called my Doctor and explained what was going on. I also started to wheeze. I used my inhaler. He told me to use my epipen. Which I already had prepared since I knew this was anaphylaxis. I started to feel stable enough to go inside. I called my husband to come downstairs to be with me. I still wasnt feeling well and the tightness and wheezing persisted. At around 8:40, My dr. told me to use the 2nd Epipen and use my nebulaizer. If I wasn't better in 10 minutes he would call an ambulance. Thank GD the itching and hives subsided and the wheezing and tightness diminished by aroung 8:50am. My dr. comtinued to monitor me and check up on me. By 3pm I was back to myself.
45 2021-02-21 lymph node swelling, swollen extremities Sore arm, swollen arm pit lymph nodes -day 2 and now. Fatigue-day 2 til now. Nausea and dizziness-da... Read more
Sore arm, swollen arm pit lymph nodes -day 2 and now. Fatigue-day 2 til now. Nausea and dizziness-day 3. Chills-day 4.
45 2021-02-24 swelling Employee reports redness and swelling to bilateral toes. Reported symptoms started approximately 3 w... Read more
Employee reports redness and swelling to bilateral toes. Reported symptoms started approximately 3 weeks following second dose of vaccine. Employee has officially reported symptoms. Referred employee for COVID testing.
45 2021-02-25 lymph node pain, lymph node swelling I experienced a swollen lymph node after the first shot on 1/12/2021. It went away within a week. Af... Read more
I experienced a swollen lymph node after the first shot on 1/12/2021. It went away within a week. After the second dose 2/2/2021 the same lymph node (left side above my collar bone , became inflamed again. It never went away but decreased in size after about 10 days. ON 2/21/the lymph node increased in size , it is the size of a grape and is very painful. I am also fatigued an have a general feeling of being unwell.
45 2021-02-25 lymph node swelling Severe swelling and pain in right arm pit, swelling in left arm pit, neck and pain in Lymph glands. ... Read more
Severe swelling and pain in right arm pit, swelling in left arm pit, neck and pain in Lymph glands. Pain under left side of breast bone and shoulder blade.
45 2021-02-26 swelling Red, swollen, itchy blotch about an 1in (so far) sore to touch
45 2021-02-27 lymph node swelling Headache, nausea, extreme fatigue, swollen glands, muscle aches
45 2021-02-27 lymph node swelling 5 minutes after the shot a sharp pain to the left side of my neck. Now my lymph nodes in the neck a... Read more
5 minutes after the shot a sharp pain to the left side of my neck. Now my lymph nodes in the neck are swollen.
45 2021-02-28 lymph node pain, lymph node swelling Headache; Muscle fatigue; Lymph node pain; Left armpit; This is a spontaneous report from a contacta... Read more
Headache; Muscle fatigue; Lymph node pain; Left armpit; This is a spontaneous report from a contactable nurse (patient). A 45-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: GL92113), intramuscular on 22Jan2021 at 14:15 at a single dose on left arm for COVID-19 immunisation. Medical history included depression, mitral valve regurgitation and hypercholesterolaemia from an unknown date and unknown if ongoing. The patient previously took guaifenesin;phenylephrine hydrochloride (ENTEX) and NOVICAINE and experienced allergies. The patient experienced headache, muscle fatigue, lymph node pain and left armpit on 22Jan2021. Treatment received for the adverse event was reported as No. The outcome of the events was not recovered.
45 2021-02-28 lymph node swelling Lymph nodes on left side swollen, Neck, upper shoulder/clavicle, & arm pit, Also right neck lymph no... Read more
Lymph nodes on left side swollen, Neck, upper shoulder/clavicle, & arm pit, Also right neck lymph node
45 2021-03-01 c-reactive protein increased, lymph node swelling, lymph node pain Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to s... Read more
Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to sleep and shortness of breath. In addition, swollen and painful lymph glands under both arms but worse in injection arm.
45 2021-03-01 lymph node pain, lymph node swelling Chills, sweats, severe body aches, headache, fevers, diarrhea, severe pain and swelling under left ... Read more
Chills, sweats, severe body aches, headache, fevers, diarrhea, severe pain and swelling under left arm, fatigue, nausea
45 2021-03-02 lymph node swelling Red rash on chest, back, neck, and arms (does not appear to be hives and does not itch); Two sudden,... Read more
Red rash on chest, back, neck, and arms (does not appear to be hives and does not itch); Two sudden, swollen nodules under my chin. Located in the center, almost directly under the center of my tongue. Very tender locally, externally; This is a spontaneous report from a contactable consumer, the patient. A 45-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:EN5318), via an unspecified route of administration in the left arm on 15Feb2021 at 09:00 (at the age of 45-years-old) as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a workplace clinic. Medical history included known Drug Allergy to: Sulfa and Cipro antibiotics.. Concomitant medication included buspirone (BUSPIRONE), bupropion (BUPROPION), vitamin c [ascorbic acid] (VITAMIN C), vitamin d vitamin d [nos] (VITAMIN D), vitamin b complex (VITAMIN B). Historical Vaccine BNT162B2 received on 25Jan2021 at 09:00 Dose 1, Lot Number EN5318 in Left arm. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 17Feb2021 at 07:00 The patient experienced red rash on chest, back, neck, and arms (does not appear to be hives, two sudden, swollen nodules under my chin, located in the center, almost directly under the center of my tongue, very tender locally, externally. The events were considered non serious. No treatment was given for the event. The clinical outcome of the event Red Rash and Lymph nodes cervical swollen was not recovered.
45 2021-03-02 swelling increased swelling and redness and neck tenderness and pain
45 2021-03-02 swelling Extreme tired Headache Achy and sore body Swelling and pain in armpit.
45 2021-03-03 lymph node swelling After my second vaccine, I experienced chills, sweats, headaches, body aches, join pain. I went to O... Read more
After my second vaccine, I experienced chills, sweats, headaches, body aches, join pain. I went to Occupational Health due to a large lymph node I also had to my vaccine, which was the size of a lemon. I took Ibuprofen for pain medication and relief of my headaches.
45 2021-03-04 peripheral swelling Onset of weight gain, lower extremity swelling 2/24/2021. Labs completed 3/1/2021, diagnosed with mi... Read more
Onset of weight gain, lower extremity swelling 2/24/2021. Labs completed 3/1/2021, diagnosed with mild rhabdomyolysis on 3/4/2021 given proteinuria, myoglobinuria, elevated CK - unknown etiology/trigger for rhabdo.
45 2021-03-04 peripheral swelling Swollen and very tender/sensitive knuckles in fingers. Painful. Excessive swelling to the point that... Read more
Swollen and very tender/sensitive knuckles in fingers. Painful. Excessive swelling to the point that wedding band doesn?t even come close to fitting on finger (which has been worn for 15 years).
45 2021-03-06 peripheral swelling Vaccine appt was at 10:00 am. Lightheadedness for about 10 seconds immediately after left arm was i... Read more
Vaccine appt was at 10:00 am. Lightheadedness for about 10 seconds immediately after left arm was injected. Later in the evening hands were swollen as if they were retaining water.
45 2021-03-07 swelling redness, pain and swelling began 7 day post injection. I also have unexplained bruising on my leg an... Read more
redness, pain and swelling began 7 day post injection. I also have unexplained bruising on my leg and thigh
45 2021-03-09 swelling face I felt fine for the 20+ minutes in waiting area after, and my 15 minute drive home. I noticed my che... Read more
I felt fine for the 20+ minutes in waiting area after, and my 15 minute drive home. I noticed my cheeks were VERY flushed. I took my temperature. Though it was 98.5, that is higher than my personal 'normal' temp. I am typically 97.3-7. Checked again on my flushed cheeks to see that my face was swollen. I ran into a neighbor, though wearing a mask, she didn't see/say anything, and I felt okay enough not to bring it up. By the end of the day, swelling in my cheeks was less noticeable so I went to bed thinking I wasn't having more than a typical vaccine reaction. I woke up the next day with swollen eyelids. I've only become concerned after googling the general side effects and saw 'swelling of the face' and/or 'swollen eyelids' listed as both "common" and "when to call a doctor". My (non)fever is up and down over the past few days though I still feel flushed with more pink in my cheeks.
45 2021-03-11 lymph node pain, lymph node swelling The day I got the vaccine around 5PM I started feeling really tired and started having symptoms from... Read more
The day I got the vaccine around 5PM I started feeling really tired and started having symptoms from the vaccine, a really bad headache, muscle aches, temperature of 100.2F, chills, nausea and I noticed my arm hurt and then my noticed my lymph nodes under my right armpit swollen (painful - lasted about a week) all other symptoms about 2 days. I had the vaccine on a Thursday, on Friday I could not even finish my work day. The overall symptoms lasted about2 or 3 days. Consulted with PCP on the phone who suggested hot and cold compresses.
45 2021-03-12 lymph node pain, lymph node swelling Sore left arm, bruise. Very sore, swollen lymph node. Sore upper left arm. No fewer and no other co... Read more
Sore left arm, bruise. Very sore, swollen lymph node. Sore upper left arm. No fewer and no other concerns. As of 3/13/21 still slight soreness.
45 2021-03-15 swelling After 20-25 mins, heart started racing, swelling started on lips, eyelids, neck , inside the mouth. ... Read more
After 20-25 mins, heart started racing, swelling started on lips, eyelids, neck , inside the mouth. Felt burning sensation in esophagus. Experience tiredness, chill and minor diziness as well. Took Benadryl every 8 hrs and pepcid from over the counter. There is still minor swelling and continuing the benadryl after 24 hrs
45 2021-03-16 lymph node swelling I can say that my symptoms actually started on my first dose 12-17-2020, experienced chills, muscle ... Read more
I can say that my symptoms actually started on my first dose 12-17-2020, experienced chills, muscle soreness, had fever of 99.4F and thought it was menopausal symptoms. After my second dose vaccine, my lymph nodes were visibly enlarged. I experienced muscle soreness, lymph nodes were enlarged, left side, had chills, sore throat, ear ache radiated towards my neck and had a viral pink eye. I felt very tired and had muscle aches. I had a fever of 99.4F, mostly chills and joint pain to my left shoulder, left hip and left knee. I also had 3 Covid swab testes which were all negative. I saw my doctor who performed a x-ray of the chest and has put off a mammogram test till April 2021. At this time I have not recovered there is something going on with my pelvis, form my iliac crest when bending down I feel a pinched lymph node on that area of iliac crest. I get a pinch on my pelvis that is painful.
45 2021-03-17 lymph node swelling Myalgia, NauseaVomiting, Tachycardia, MILD LIGHTHEADEDNESS, MILD CHEST TIGHTNESS, SHORTNESS OF BR... Read more
Myalgia, NauseaVomiting, Tachycardia, MILD LIGHTHEADEDNESS, MILD CHEST TIGHTNESS, SHORTNESS OF BREATH, MILD SCRATCHY/TIGHTENING OF THE THROAD, MILD SWELLING OF THE TONGUE, MODERATE FACIAL PAIN ALONG CHEEKBONES/JAWLINE/UPPER JAW, INJECTION SITE PAIN, SWOLLEN GLANDS Narrative: Other Relevant History:
45 2021-03-17 swelling Patient received Pfizer Covid-19 vaccine at an off-site clinic. Patient complained of being light-he... Read more
Patient received Pfizer Covid-19 vaccine at an off-site clinic. Patient complained of being light-headed/dizzy. She appeared frightened and after a couple of minutes felt as if her lips were beginning to swell. Patient was offered and received benadryl liquid orally and felt better after 15 more minutes and left after declining any additional treatment.
45 2021-03-17 swelling Approximatey 1hr after the vaccination, c/o of feeling internal itching all over but under the skin ... Read more
Approximatey 1hr after the vaccination, c/o of feeling internal itching all over but under the skin at 4:30. An hr later c/o "flu like symptoms e.g. aches and pains, then had to take a nap. Woke up the next morning c/o soarness, itching, and self-administred Zyrtec 1 po in a.m then again in the p.m. Felt some relief but a little achey just flu-like. Most of Sunday felt the same but Sunday approx 6p broken out into red whelts on the chest and back, throat felt like it was starting to close in and I went to the ER at approximately 8 p.m. Was given Prednasone 10 day pack, and Benadryl both p.o. Did receive somewhat relief from the Rx. Nothing was done to airway. Continues to c/o itching underneath the skin
45 2021-03-18 lymph node swelling Swollen under arm lymph node (same side of the arm as injection site)-Did not go away until 3-4 days... Read more
Swollen under arm lymph node (same side of the arm as injection site)-Did not go away until 3-4 days after shot. Fatigue Injection site soreness Mild headache
45 2021-03-18 swelling, swollen extremities, peripheral swelling Swelling in left arm down to hand and fingers. My hand and fingers went numb until I took Tylenol. L... Read more
Swelling in left arm down to hand and fingers. My hand and fingers went numb until I took Tylenol. Less than 24 hours I was in severe pain. Felt like my bones hurt. Swelling on the left side included my armpit and left side of the torso down to the waist. The pain stayed for another day. Felt like I had the flu. Swelling in the armpit and upper left torse stayed for about three weeks. Wednesday, March 17 I went to the ER for chest pains, throat tightening, pain from my shoulder to my hand on the left side.
45 2021-03-19 swelling Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection ... Read more
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: cellulitis, growing erythema, swelling, heat. Given ATB-Medium, Additional Details: Pt given ATB for increased swelling, erythema, heat. Pt has daily tracked progression. Site circled, currently 14 cm today in L detoid. Lot number of COVID-19 immunization not available to NP in Clinic.
45 2021-03-21 anaphylactic reaction anaphalaxis, epicene, benadryl, pepsid
45 2021-03-21 lymph node swelling Within 8 hours, felt very fatigued and had chills. Within 24 hours, lymph node under my left arm swe... Read more
Within 8 hours, felt very fatigued and had chills. Within 24 hours, lymph node under my left arm swelled to the size of a kiwi. Swelling gradually reduced over 2 days to the size of a large grape. Very hot and painful. I have never had such an extreme reaction to a vaccine.
45 2021-03-21 swelling face after 10 min I started a headache, then felt lightheaded getting worse as time pass, then my lips st... Read more
after 10 min I started a headache, then felt lightheaded getting worse as time pass, then my lips started to tingling, then my cheeks, then my tongue. My cheeks started to get red and a bit swollen, then my breathing was getting weird, my blood pressure rise. At that moment I agreed to go in the rescue.
45 2021-03-21 swelling Inflammation, swollen neck and underarm of the side the vaccine was given. Fatigue sensation and hea... Read more
Inflammation, swollen neck and underarm of the side the vaccine was given. Fatigue sensation and headache
45 2021-03-21 swelling Within 10 minutes of receiving the injection, as I was scheduling my second dose and then while I wa... Read more
Within 10 minutes of receiving the injection, as I was scheduling my second dose and then while I was waiting, my left should (upper left side of my back) started aching. I do not normally have any kind of a response to any vaccine, so I didn't immediately connect this pain with my COVID-19 vaccine, however, it continued to get progressively worse and ultimately became my entire arm, shoulder, neck and head. I had a lot of difficulty sleeping for the next two nights and I noticed yesterday morning (Sunday, 3/21/21) that my left clavicle was completely obscured by significant swelling (I assume lymphnodes). Golf ball-sized swelling. Today (Monday, 3/22/21) the swelling continues to be significant and I think maybe covering more area. Not as pronounced of a lump, but more of a squashed, larger lump, if that makes sense?
45 2021-03-22 lymph node swelling Pfizer-BioNTech COVID-19 Vaccine EUA: patient has a mild urticarial, erythematous, macular rash on f... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient has a mild urticarial, erythematous, macular rash on face, neck, and exposed area of chest that started four days after receiving vaccine. Lymph nodes are also swollen. Denies chest pain, shortness of breath, flu-like symptoms, fever, itching, or swelling at injection site. Patient has experienced urticarial symptomns with upper repiratory infections in the past. Provider recommended diphenhydramine and home management.
45 2021-03-22 swelling face 48 hours later moderate to severe facial swelling, erethema, worsening over 2 more days slowly subs... Read more
48 hours later moderate to severe facial swelling, erethema, worsening over 2 more days slowly subsiding after day 3 of benadryl
45 2021-03-22 swelling lethargy, low fever. swollen neck(both sides), painful arm and breast on same side of injection. sor... Read more
lethargy, low fever. swollen neck(both sides), painful arm and breast on same side of injection. sore throat
45 2021-03-23 lymph node swelling swollen lymph nodes, Muscle and body aches, Fatigue, Headache, chills. The symptoms last for four d... Read more
swollen lymph nodes, Muscle and body aches, Fatigue, Headache, chills. The symptoms last for four days.
45 2021-03-23 lymph node swelling Headache, Myalgia, Arthralgia, Fever, EXTREME TIREDNESS, INJECTION SITE PAIN, SWOLLEN GLANDS Narrat... Read more
Headache, Myalgia, Arthralgia, Fever, EXTREME TIREDNESS, INJECTION SITE PAIN, SWOLLEN GLANDS Narrative:
45 2021-03-23 swelling First Vaccine was 1/13/21 same location. I received the 2nd dose of the COVID-19 Vaccine (Pfizer) on... Read more
First Vaccine was 1/13/21 same location. I received the 2nd dose of the COVID-19 Vaccine (Pfizer) on 2/3/21. On 2/4/21 I had body aches, headache, low grade fever, joint pain. On 2/5/21 Fever up to 102, severe body aches and headache and joint pain. By 2/6/21, most S/S had gone no more fever or body aches. However, I noticed significant swelling Left shoulder blade and arm pit. Left shoulder was painful to touch and arm pit was sore. The headache continued but milder now located almost completely at base of skull. By 2/17/21 I noticed the swelling in Left shoulder blade had gone down, however the armpit remained very swollen. Also, in addition I have a lot of bilateral swelling in my neck most noticeable right above my clavicle on both sides. This swelling is also painful and my neck is very stiff and painful to turn to the sides. I saw my PCP on 3/19/21 regarding as I am now over 6 weeks post vaccination.
45 2021-03-25 swelling face Really sore arm the day after. Developed a full body rash anout 36 hours after the shot. 48 hours la... Read more
Really sore arm the day after. Developed a full body rash anout 36 hours after the shot. 48 hours later developed a bright red. burning and painful rash on my face. On day 3 I went to work and underneath my right eye started to swell up and a red streak from the inner corner of my eyelid went down my face. On day 4 I woke up with both eyes swollen. I started on benedryl. 2x a day. The redness, welts and hives traveled down my face, onto my neck, then up my forehead and onto my earlobes. On March 22, day 5, I woke with even more swelling on my face and both eyes. The rash was very bad. I called my primary care physician and made an appointment to see him on Tuesday. I went for that appointment and dr. gave me antihistamines, took pictures and reported it to CDC. I started the antihistamines, but on Day 7, I woke up with the worst of it. Hives all down my neck, lips swollen, bruising and swollen eyes and itchy red rash everywhere. I called the dr back and started prednizone steriods. Today, March 26, it is starting to calm down.
45 2021-03-25 swelling Symptoms felt at 8p on day of vaccination (6 hours after dose): Pain Swelling Symptoms beginning T... Read more
Symptoms felt at 8p on day of vaccination (6 hours after dose): Pain Swelling Symptoms beginning Tuesday, 3/23/2021, one day after dose: Rash Symptoms beginning Thursday, 3/25/2021: Itching
45 2021-03-26 neck mass left neck mass. CT neck showed: IMPRESSION: 1. Left axillary and left supraclavicular lymphadenop... Read more
left neck mass. CT neck showed: IMPRESSION: 1. Left axillary and left supraclavicular lymphadenopathy, most likely related to recent ipsilateral COVID vaccination. The left supraclavicular lymph node corresponds to the finding on ultrasound. Recommend continued clinical follow-up for the palpable abnormality. If the palpable lymph node persists or enlarges, follow-up imaging may be considered. 2. Hepatic steatosis. 3. Mild paranasal sinus disease.
45 2021-03-26 swelling Whole body inflammation, tingling and pain from neck to fingers down right arm. Also, hives from rig... Read more
Whole body inflammation, tingling and pain from neck to fingers down right arm. Also, hives from right forearm to elbow.
45 2021-03-28 lymph node swelling swollen lymph node
45 2021-03-28 white blood cell count increased On approximately 1/4/21, 1 week after 1st vaccine dose, developed headache & a head cold. Went to EN... Read more
On approximately 1/4/21, 1 week after 1st vaccine dose, developed headache & a head cold. Went to ENT on 1/11, diagnosed with acute on chronic sinusitis, prescribed Augmentin & Prednisone to start 48 hours after 2nd vaccine dose. Sinusitis did not explain headache as I've never presented with headache in the past. 2nd vaccine dose 1/14/21; began Augmentin & Prednisone on 1/16 (wanted to hold off on treatment until after 2nd vaccine dose). Headache continued & began to worsen. I thought maybe due to prednisone or high blood pressure from prednisone? Visit to PCP on 1/25 due persistent headache that was not resolving (Headache was vice-like, pain moderate to severe, headache worse with exertion or bending over). 1/25 "worst headache of my life". MRI ordered & completed 1/27; MRI normal other than sinusitis. Visit to ENT on 1/28; she said sinusitis improving & prescribed Norco for headache pain. Visit to PCP on 1/30; he prescribed Gabapentin & Naproxen for headache pain. Visit to Naturopath on 2/4; recommended adding Magnesium & B Vitamin Complex. 2/5: Massage with worsening headache pain. 2/10: Chiropractor & Acupuncturist with worsening headache pain. 2/19: Visit to Urgent Care for Toradol shot & Cyclobenzaprine prescribed. 2/23: Visit with Neurology; prescribed Topamax & Prednisone. 3/5: felt strange sensations in body, wave like feeling over limbs, tension in skull, heart pounding, change of hearing, menthol sensation on skin, change of taste, worsening headache, warm feeling in chest & abdomen, lasts 1-2 minutes. 3/6: ED visit due to strange episode/sensations; Neurologist on call prescribed Fioricet & Nortriptyline. 3/9: visit to Neurology, she increased metoprolol to 50mg, injected Ajovy, prescribed more cyclobenzaprine & ordered MRI/MRV. Headache pain continued to be moderate to severe, constant & "nervy", episodes continued to occur daily. 3/12: bloodwork to check inflammation. 3/14: MRI/MRV completed. Headache worsened with MRI noise & injection of contrast. 3/16: lumbar puncture completed w/ normal pressure, awaiting CSF labs. Discontinued Topamax 3/21; thought maybe contributing to episodes. More bloodwork completed 3/24. Visit to PCP, given Nurtec sample with some relief. Otherwise, headache remains daily & persistent with little/no relief overall. Head pain is bilateral, vice-like, burning sensation @ times on skull or face, numbness & tingling both sides of face periodically. Headache worsens with activity & at night. Episodes (strange sensations) continue to occur 1-3x/day, usually when laying down, at night or in morning.
45 2021-03-29 peripheral swelling, swelling face Pain in shoulder, neck and wrist. Swelling of face under eyes and cheeks. Swelling in hands and f... Read more
Pain in shoulder, neck and wrist. Swelling of face under eyes and cheeks. Swelling in hands and feet.
45 2021-03-30 lymph node pain, lymph node swelling It started with my hands aching and then I had a lot of body aches. By noon, I had a terrible headac... Read more
It started with my hands aching and then I had a lot of body aches. By noon, I had a terrible headache and was running a fever. Later, the lymph node under my arm on the side of the injection was swollen and a little painful.
45 2021-03-30 lymph node swelling 1.) Right axillary lymphadenopathy starting the morning following the injection (3/30/21) and not re... Read more
1.) Right axillary lymphadenopathy starting the morning following the injection (3/30/21) and not resolved at the time of this report. Slight discomfort associated with the lymphadenopathy when right arm positioned or held close to body. Took 200mg Ibuprofen before bed on 3/30/21 to help with discomfort. 2.) Body chills noted throughout the day on 3/30/21. Resolved as of 3/31/21. Not associated with a fever. No treatment. 3.) Headache noted throughout the day on 3/31/21. Resolved as of 3/31/21. No treatment.
45 2021-03-30 lymph node swelling Exercise intolerance; Chest pain; Lymphadenopathy; Fever; Severe neck pain; Fatigue.; Myalgia; Heada... Read more
Exercise intolerance; Chest pain; Lymphadenopathy; Fever; Severe neck pain; Fatigue.; Myalgia; Headache; Dizziness; This is a spontaneous report from a contactable physician. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:EL9262 ,expiration date not reported), via an unspecified route of administration, administered on the right arm on 23Jan2021 14:00 (at the age of 45-years-old) at single dose for COVID-19 immunization. Medical history included asthma and known allergies: latex. Concomitant medications included melatonin (manufacturer unknown), ubidecarenone (COQ10 [UBIDECARENONE]), ergocalciferol (VIT D); fexofenadine hydrochloride (ALLEGRA), and birth control all taken for an unspecified indication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:Ek9321, expiration date not reported), via an unspecified route of administration, administered on the left arm on 02Jan2021 18:00 at the age of 45 years-old at single dose for COVID-19 immunization and experienced headache, myalgia, chills, lymphadenopathy and brain fog on 03Jan2021. On 24Jan2021 08:00, the patient experienced fever, severe neck pain, fatigue, myalgia, headache, and dizziness. On 25Jan2021, the patient experienced fever, lymphadenopathy, fatigue, myalgia and dizziness. On 26Jan2021 and 27Jan2021, the patient continued to experience the events previously stated with headache. On 28Jan2021, the patient continued to experience the events previously stated with chest pain. On 29Jan2021 to 31Jan2021, the patient continued to experience the events previously stated. On 01Feb2021, the patient experienced continued fever, fatigue, lymphadenopathy, chest pain, and exercise intolerance. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jan2021. Events resulted in physician office visit and was treated by steroid. Outcome for events reported were not recovered.
45 2021-03-30 peripheral swelling, lymph node swelling lymphatic nodes were swollen; right knee swollen; cannot walk yet; Leg pain; other specified soft ti... Read more
lymphatic nodes were swollen; right knee swollen; cannot walk yet; Leg pain; other specified soft tissue disorders.; leg bumps/or swelling; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 16:30 (Batch/Lot number was not reported), at the age of 45-year-old at vaccination, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient is not pregnant at the time of vaccination. There were no concomitant medications. The patient previously took NSAIDS and experienced drug hypersensitivity. The patient did not have COVID prior vaccination. On 09Mar2021 06:00, the patient woke up with her right knee swollen and had difficulty walking. She went to the Hospital in the afternoon and was told that her lymphatic nodes were swollen, and the diagnosis is Leg pain and swelling and other specified soft tissue disorders. The still have a swollen knee and cannot walk yet, 6 days after the vaccine. The patient still have leg bumps/or swelling in her leg. The patient was hospitalized for lymphatic nodes were swollen. It was also reported that patient has physician and ER visit. The patient was not tested for COVID post vaccination. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events which includes Codeine/paracetamol, RICE routine care for injury. Information about Batch/Lot number has been requested.
45 2021-03-30 peripheral swelling Swollen eyes, mouth, hands Labored breathing Kidney pain Elevated HR Treated with benadryl and resc... Read more
Swollen eyes, mouth, hands Labored breathing Kidney pain Elevated HR Treated with benadryl and rescue inhaler
45 2021-03-30 swelling Red swollen area warm to the touch and itchy 8 days after vaccine
45 2021-03-31 axillary mass Headache, severe body aches, lump in left arm pit, and chills which lasted 24 hrs.
45 2021-04-01 lymph node swelling it was worse; I had to take Benadryl to sleep; eye lid tingling; Also reports pain on the top of her... Read more
it was worse; I had to take Benadryl to sleep; eye lid tingling; Also reports pain on the top of her head and last night aching on left side of her head; Eyelids with poking sensation; lip is jerking, jerking of eyes; pain on left side of her neck; I feel my gland is swollen with a lump on left side; I have had tingling and a needle pain sensation all over my body./Tingling needle like sensation like someone poking needles, eyelids, arms, legs, back, face, belly, all over body, tips of fingers, bottom of feet, top of head; Has to work through the pain/Pain ran down along left side of neck a couple of nights ago also;; Left top of head aching sensation; It is effecting her work and daily life.; This is a spontaneous report from a contactable pharmacist. A 45-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205, Expiration date: not reported via an unspecified route of administration, administered in Arm Left on 06Mar2021 at 14:25 (at the age of 45-years-old) as single dose for COVID-19 immunization. Medical history included ongoing hepatitis B, Kidney stone from 2019 and ongoing. Concomitant medication(s) included tenofovir disoproxil fumarate (Dosage text : 300mg Tablet once daily at night) taken for hepatitis b. The patient's father has high blood pressure and heart problems and mother is fine as stated. The patient experienced tingling and a needle pain sensation all over my body/tingling needle like sensation like someone poking needles, eyelids, arms, legs, back, face, belly, all over body, tips of fingers, bottom of feet, top of head on 07Mar2021, had to take benadryl to sleep on an unspecified date with, eye lid tingling on an, on 16Mar2021 lip is jerking, pain on left side of her neck, feel the gland is swollen with a lump on left side, also reports pain on the top of her head and last night aching on left side of her head, eyelids with poking sensation, jerking of eyes, left top of head aching sensation, it is effecting her work and daily life, has to work through the pain/pain ran down along left side of neck a couple of nights ago. Therapeutic measures were taken as a result of insomnia. The outcome of event Tingling needle like sensation like someone poking needles, eyelids, arms, legs, back, face, belly, all over body, tips of fingers, bottom of feet, top of head, Lips Jerk, Jerking of Eyes, Left side of neck lump like a swollen lymph is Not Recovered, Left top of head aching sensation, Pain ran along left side of neck is Recovered. Follow up (17Mar2021): New information included clinical information and description of product complaint: Is there a Product Complaint: Taking benadryl last two nights to sleep, did not help last night. Product strength and count size dispensed: 25mg. Additional lot numbers: P117225. Is a sample of the product available to be returned, if requested: No No follow-up attempts are possible. No further information is expected.; Sender's Comments: Considering a plausible temporal association, a causal relation between the reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
45 2021-04-02 swelling Fever, chills, headache, neasea, fever, swelling & redness at injection site, dizzy
45 2021-04-03 lymph node pain, lymph node swelling Painful swelling of lymph nodes near collarbone
45 2021-04-03 lymph node swelling Severe chills and hot flashes, difficulty breathing, chest pain, nausea, headache, rapid heartbeat. ... Read more
Severe chills and hot flashes, difficulty breathing, chest pain, nausea, headache, rapid heartbeat. Swollen lymph nodes in armpits and under jaw. Bed rest, sleep, daytime/nighttime cold medicine, liquids.
45 2021-04-05 peripheral swelling I started experiencing swelling and pain in my ankle and right leg.
45 2021-04-05 swelling face Patient had facial swelling, lip swelling, and tongue heaviness two days after recieving the second ... Read more
Patient had facial swelling, lip swelling, and tongue heaviness two days after recieving the second dose of vaccine. She took Benadryl 25 mg every six hours and this resolved in three days.
45 2021-04-06 lymph node swelling, lymph node pain Initial reaction: night of April 1-2: moderate leg aches, restlessness, hip joint pain, feeling fev... Read more
Initial reaction: night of April 1-2: moderate leg aches, restlessness, hip joint pain, feeling feverish w/out fever, mild chills April 2-3: moderate to severe fatigue, lethargy symptoms eased on evening of April 3 Secondary reaction: April 4, evening through today, April 7: lymph nodes in left armpit, left side of neck, left jaw sore and tender, possibly slightly swollen. Back left jaw felt slightly numb on first day. Left side of neck feels as if muscles sprained. No fever. Brief, mild tenderness at injection site on right arm.
45 2021-04-07 lymph node swelling swollen, infected lymph node. Took antibiotics and the symptoms disappeared with in 5 days.
45 2021-04-08 axillary mass, peripheral swelling Two days after the vaccine my arm became really hot and swollen. It was a circle about the size of a... Read more
Two days after the vaccine my arm became really hot and swollen. It was a circle about the size of a baseball on my left arm around the site of injection. It looked like cellulitis. I also had a lump under my arm. II took some Tylenol which helped. It was there for almost two weeks and it gradually went down. The Lymph node under my arm also went down in the same amount of time. I am nervous about getting the second dose.
45 2021-04-08 lymph node inflammation Developed necrotizing lymphadenitis in axillary right arm and all the biopsies suggest is vaccine re... Read more
Developed necrotizing lymphadenitis in axillary right arm and all the biopsies suggest is vaccine related.
45 2021-04-08 lymph node swelling Extreme fatigue, swollen lymph nodes, muscle aches
45 2021-04-08 swelling face On Thursday 3/18 around 5:00 I started feeling tired, went to bed early woke up Friday with my eyes ... Read more
On Thursday 3/18 around 5:00 I started feeling tired, went to bed early woke up Friday with my eyes burning, the skin around my eyes was red, creapy, and was burning and itching. It was mainly my eyes, but my face felt puffy. My torso felt hot from inside. My throat felt swollen towards the top. By Friday night it was getting worse so I took Benadryl and sat with ice packs on my eyes, and put hydrocortisone around my eyes and eyelids. I continued that til Tuesday when it finally subsided. I did take pictures of my face, and I contacted my doctor to ask about the second shot. They advised against it, so I?ve cancelled my appointment. I might try the J & J shot in a few months.
45 2021-04-10 lymph node pain Headache, significant aches, sharp pain in lymph nodes under arm and rib cage in side in which shot ... Read more
Headache, significant aches, sharp pain in lymph nodes under arm and rib cage in side in which shot was given
45 2021-04-10 lymph node swelling Pfizer-BioNTech COVID-19 Vaccine EUA Swollen lymph nodes in right arm pit Started after day 5 of vac... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Swollen lymph nodes in right arm pit Started after day 5 of vaccination and at time of report is still significantly swollen.
45 2021-04-10 lymph node swelling Sore throat, swollen throat, coughing, tongue feels scraped on both sides, feels like it is swollen... Read more
Sore throat, swollen throat, coughing, tongue feels scraped on both sides, feels like it is swollen, so hurts to eat or chew. Chronic constant headache, swollen glands, ears feel plugged. Bloody nose. Lips suddenly extremely chapped and raw. Hurts to swallow.
45 2021-04-10 oral herpes woke up drenched in sweat, not sure if she had fever, has cold sore on lip, lip swollen
45 2021-04-10 peripheral swelling PT STATES 4/7 AT 3PM SHE NOTICED SWELLING IN LEG AND WENT TO ER. DIAGNOSED AS SUPERFICIAL BLOOD CLOT... Read more
PT STATES 4/7 AT 3PM SHE NOTICED SWELLING IN LEG AND WENT TO ER. DIAGNOSED AS SUPERFICIAL BLOOD CLOT IN LEFT LEG. SHE WAS TOLD TO COLD COMPRESS, WALK AND ELEVATE TO REDUCE SWELLING. TODAY SHE FELT DIZZY AND THOUGHT SHE MIGHT HAVE MORE BLOOD CLOTS, SHE WAS REFERRED TO ER AGAIN WHERE THEY GAVE HER ASPIRIN 81MG AND THERE WERE NO ADDITIONAL CLOTS, HER FIRST VISIT CLOT WAS HEALING.
45 2021-04-11 peripheral swelling Extreme fatigue after fourth hour. Bodyaches including neck, shoulder, down my entire back. Swelling... Read more
Extreme fatigue after fourth hour. Bodyaches including neck, shoulder, down my entire back. Swelling in both hand joints and soft tissue. Pain in both wrists, pain shooting down my R Arm (injection arm), wheezing/asthma symptoms. On the 5th day after the first dose, injection site is throbbing painfully, especially at night. Massage, hydrating, heat, cold compress, and CBD roll-on ointment does not alleviate the pain. Pain has been occurring nightly for 5 nights now.
45 2021-04-12 lymph node swelling Day after vaccination fatigue, swollen lymph nodes. All swollen lymph nodes are on left side of bod... Read more
Day after vaccination fatigue, swollen lymph nodes. All swollen lymph nodes are on left side of body, same as shot. Nodes in armpit were swollen to about the size of half a tennis ball and very painful. Armpits were sore and swollen for approximately 4 days. After that swelling and pain were less intense. Nodes on neck and head painfully enlarged. They remain painfully swollen 1 week after shot.
45 2021-04-12 peripheral swelling My left arm is swollen, red and itchy.
45 2021-04-13 axillary mass My right arm is where I had the 2nd shot administered (used Left arm for dose #1). I had my shot at... Read more
My right arm is where I had the 2nd shot administered (used Left arm for dose #1). I had my shot at 1:30pm on 4/12/21 and noticed sore arm pain throughout the day. Tuesday 4/13/21 at 9am my entire body began to ache and was sensitive to touch and I was tired. Tuesday evening at 10pm 4/13/21 my right armpit began to ache. The aching remained all night and all day into Wednesday 4/14/21. I can feel a lump (assuming lymph node) under my armpit. It has become more painful to move as the day goes on. I have also had some tingling in my right arm and lower back pain.
45 2021-04-13 lymph node pain Severe Lymph node pain and pain radiating into my breasts. Under my breasts. Sides of breasts. Subsi... Read more
Severe Lymph node pain and pain radiating into my breasts. Under my breasts. Sides of breasts. Subsided after a week but still have a bit of pain nearly 3 weeks later. Went into doctor for manual breast exam. No lumps. This is almost certainly from the vaccine. The pain in both breasts was shifting through all the lymph drainage areas. I expect it to completely be gone by the time I get a mammogram in a month. It has improved a lot. I also had a headache and fatigue.
45 2021-04-13 lymph node swelling, peripheral swelling, swelling Swelling of left arm, left lymph node, left breast, swelling of back, diarrhea, headache
45 2021-04-14 lymph node swelling Swollen lymph node and pain in arm pit in arm where injection was given.
45 2021-04-15 swelling face Dizzy after first injection for 12 hours. Dizzy and throat tightness approx 1 hour after 2nd inject... Read more
Dizzy after first injection for 12 hours. Dizzy and throat tightness approx 1 hour after 2nd injection. Took inhaler with relief. Approx 1030pm stomach gurgling, abdominal pains , diarrhea started. 11pm fever 102 started and severe shaking chills. Fever continued until 4/15 530am despite Motrin. 4/14 early morning hours noticed face bright red like a beet and swollen. Throat tight and cough. Took Benedryl and Pepcid every 4 hours along with Motrin. My primary care had no appointments, tried urgent care and they referred me to ED. I was so sick I couldn?t sit up and go to ED. Watched pulse ox and vitals at home. Got a telehealth appointment 4/16 today with my doctor. Told to continue Benedryl every 4-6 hours until all symptoms are gone. Continue with headache, weakness, dizziness, throat tightness on and off, lack of appetite and mild abdominal pain today. Lost 4-5 pounds since Tuesday.
45 2021-04-16 fluid retention Aches, low grade fever, fatigue, fluid retention (whole body)
45 2021-04-17 swelling face Within 10 minutes of getting the vaccination my face started feeling tight and I started feeling dis... Read more
Within 10 minutes of getting the vaccination my face started feeling tight and I started feeling discomfort in my throat. By the time the 15 minutes was up my face and lips were completely swollen and I started feeling lightheaded. I was given steroids and Benadryl through an IV and was given an EpiPen injection.
45 2021-04-17 swelling Delayed cutaneous hypersensitivity: Two days after vaccination, developed large (5 inch by 2.5 inch... Read more
Delayed cutaneous hypersensitivity: Two days after vaccination, developed large (5 inch by 2.5 inch) red patch on left upper arm which was slightly swollen, mildly itchy, and warm to the touch.
45 2021-04-18 anaphylactic reaction 15 minutes after the injection I had an intense allergic/anaphylactic reaction. I was watched and t... Read more
15 minutes after the injection I had an intense allergic/anaphylactic reaction. I was watched and treated on site by EMS for 2 hours with Benadryl, oxygen and rest. We did not use epi because I was still able to breath (minus some wheezing, coughing, hoarseness and lung irritation). I felt the reaction hit when I started seeing green spots and my vitals dramatically increased (BP 181/111, HR 142 and weak). I then experienced the following symptoms: rash/hives on neck and chest, fatigue and weakness, dizzy and lightheaded and needed wheelchair for moving around, chills and shaking, blurry vision, nausea, stomach pain, headache, chest pain and increased urination. I also had elevated glucose (147). During those two hours my vitals decreased a little, but the rest of my symptoms persisted. I was not getting better and my vitals started to increase again at the two hour mark so EMS called an ambulance and transported me to hospital. I was treated with solumedrol and observed for several hours. The meds helped enough to send me home. (I did have to continue taking Benadryl at home that night and the next day because I continued to have an allergic response). I also had severe injection site pain and bruising.
45 2021-04-18 lymph node swelling Numbness and tingling in face ~45 min after shot, started with left side, then included mouth, went ... Read more
Numbness and tingling in face ~45 min after shot, started with left side, then included mouth, went away after ~15 min, and came back off and on a few times over next few days; extremely swollen lymph node on left side, noticed ~45 min after shot, went away by next day; headache, minor aches in joints for 1 night
45 2021-04-18 lymph node swelling 9 days after the vaccine I still have a very inflamed throat, chronically and visibly inflamed lymph... Read more
9 days after the vaccine I still have a very inflamed throat, chronically and visibly inflamed lymph nodes. I have 4 days of anti-inflammatory treatment but no results.
45 2021-04-19 lymph node swelling, lymph node pain Swollen painful lymph node in left armpit (size of a small orange), small painful nodes in left brea... Read more
Swollen painful lymph node in left armpit (size of a small orange), small painful nodes in left breast, 101.9 fever for 2 days. body aches, chills
45 2021-04-19 lymph node swelling, peripheral swelling Got shot noon Thursday no adverse effects besides moderately tired until 3pm Friday. Then fatigue s... Read more
Got shot noon Thursday no adverse effects besides moderately tired until 3pm Friday. Then fatigue set in, headache, fever of 101, and lymph nodes in left arm very tender and swollen to size of goofball. Night sweats on Friday night and struggling to sleep because of tenderness under arm. Saturday morning adding left lymph node in collarbone area swollen. Both were swollen the size of eggs, warm to the touch and very tender. But no more fever. However still fatigued. The injection site still warm, slightly swollen, and patches of red on left arm. For 5 days my left arm ached, tingling and began to feel numb. Used ibuprofen, Tylenol, cool and warm compresses, and slept a lot. Woke Monday to now adding right collarbone lymph node starting to swell. Called Dr on Monday and went in at 4:30pm. Just continued same home treatment understanding it may take weeks to get back to normal.
45 2021-04-20 lymph node swelling Lymph nodes in the right armpit have swollen to golf balled sized lump which is hard and painful. A ... Read more
Lymph nodes in the right armpit have swollen to golf balled sized lump which is hard and painful. A few lesser swollen lymph nodes in the right side of the neck. Headache, sore muscles, and fatigue also.
45 2021-04-20 lymph node swelling Headache, muscle aches, swollen glands, foggy thinking, fatigue
45 2021-04-20 swelling face Severe swelling of face (especially eyes), rash on chest and back, skin felt hot.
45 2021-04-20 swelling face I had fever,body pains and sore arm for 2 days . Slight itchiness, rash started on 3rd day and start... Read more
I had fever,body pains and sore arm for 2 days . Slight itchiness, rash started on 3rd day and started increasing with swollen face, rash increasing and itchiness. Took OTC drugs for couple of days but didn?t help much. Visited the doctor and they prescribed steroids.
45 2021-04-21 peripheral swelling arm felt tingly when shot went in and immediately started to hurt on forearm between elbow an wrist.... Read more
arm felt tingly when shot went in and immediately started to hurt on forearm between elbow an wrist. immediately that area swelled up and turned red. today (4/22) it is still significantly swollen, though swelling has decreased. also immediately felt "spacey" and feet and forehead felt tingly. within 30 minutes it felt odd to walk because legs/feet felt a bit numb. the spacey feeling stayed for 6 full days during which i felt exactly the same as i had when i had a concussion about 6 years ago. i could think but i couldn't multi-task, communicate well, focus well, speak normally. it's hard to explain but it felt like i had a concussion and it was really scary. i tried to drive at day 6 and realized i could not do it. by day 7, my head started to clear up and i felt better mentally.
45 2021-04-22 swelling, peripheral swelling pain and pulling sensation under my arm. uncomfortable sensation in chest, back. moderate pain and s... Read more
pain and pulling sensation under my arm. uncomfortable sensation in chest, back. moderate pain and swelling in arm, chest and back that lasted 4 days. severe headache lethargy, fogging /hangover sensation
45 2021-04-23 lymph node pain, lymph node swelling Swollen painful lymph nodes in under arm, along collarbone, and neck up to base of the skull on the ... Read more
Swollen painful lymph nodes in under arm, along collarbone, and neck up to base of the skull on the left side.; Swollen painful lymph nodes in under arm, along collarbone, and neck up to base of the skull on the left side.; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: el3247), via an unspecified route of administration in left arm on 05Feb2021 at 08:45 at single dose for COVID-19 immunisation. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: el3247), via an unspecified route of administration in left arm on 15Jan2021 at 08:45 AM at single dose for COVID-19 immunisation. Medical history included allergies to cephalexin and codine. Concomitant medications included ibuprofen (ADVIL). On 06Feb2021 at 08:00 AM, the patient experienced swollen painful lymph nodes in under arm, along collarbone, and neck up to base of the skull on the left side. The patient was not pregnant at the time of vaccination. No treatment was received. The patient was not tested covid-post-vaccination. The outcome of the events was recovering. Follow up (17Feb2021): This follow up report contains no new medically significant safety information. Follow up (18Feb2021): This follow up report contains no new medically significant safety information.
45 2021-04-24 lymph node pain Pain in arm a few days, then fatigue set in, then worse fatigue, then flu-like pain, for several day... Read more
Pain in arm a few days, then fatigue set in, then worse fatigue, then flu-like pain, for several days, then arms and legs felt heavy and lymph nodes painful everywhere all over my body, then shakiness, severe pain behind my neck/shoulders/back, legs feel like lead, arms lead, fuzzy feeling in my head because my arms and legs won't work properly, pain, just pain everywhere, fatigue and can't move. Mostly the pain is the worst part of it. Pulsating feeling in my lymph nodes and all over my body. It's been three weeks since vaccination and it's only gotten worse.
45 2021-04-24 white blood cell count increased Pt c/o sore arm, left sided m=body malaise 8 hours after vaccine, then diffuse body pain and malaise... Read more
Pt c/o sore arm, left sided m=body malaise 8 hours after vaccine, then diffuse body pain and malaise. took IBU 800mg. CBC and CMP clinically unremarkable with no elevation of white blood cell count. HOWEVER, urine with 388 white cells/36 red cells/few bacteria and positive leukocyte esterase/nitrites. Chest x-ray without abnormalities. EKG showed sinus tachycardia at 108. No acute ST or T abnormalities. No ectopy. Renal ultrasound showed a non-obstructing stone in the kidney, but no hydronephrosis. COVID and Respiratory Panel were all negative. ER COURSE: Patient had already be given IV fluids/Tylenol/morphine prior to my evaluation and was feeling slightly better, but was still having generalized body aches and malaise... Blood cultures were drawn, and IV Rocephin was given. A second dose of morphine and Benadryl was needed to get the patient somewhat comfortable, but was still having severe body aches and malaise MEDICAL DECISION MAKING: Initial thought was adverse reaction to COVID vaccine, but patient also with significant UTI, febrile, and severe body pain requiring multiple doses of IV narcotics for control... Question of adverse reaction to vaccine and or UTI/early pyelonephritis or combination of both... Hospitalist was consulted to evaluate the patient... Will admit for observation status and continued IV medications. Date of hospitalization = 4/24/2021
45 2021-04-25 lymph node pain, lymph node swelling Swollen and painful lymph nodes in left arm - armpit area. The pain and swelling were noticed the f... Read more
Swollen and painful lymph nodes in left arm - armpit area. The pain and swelling were noticed the following morning. It has been three days and the soreness and swelling is still present
45 2021-04-25 lymph node swelling Swelling of lymph nodes under left arm (shot arm) Fatigue
45 2021-04-25 peripheral swelling Swollen arm, headache, chills, fever, body aches
45 2021-04-26 axillary mass Severe body and muscle pain with trouble walking. Headache, dizziness, nausea, lump formed in my lef... Read more
Severe body and muscle pain with trouble walking. Headache, dizziness, nausea, lump formed in my left armpit, and couldn?t stay awake with low fever of 100.1
45 2021-04-28 peripheral swelling As described by the patient: As they were putting the vaccine, the area got really warm, and the ar... Read more
As described by the patient: As they were putting the vaccine, the area got really warm, and the arm began to feel inflated. Then I began to feel the liquid moving through my arm, elbow, and wrist. My wrist started hurting. I told the nurse, who told me to keep moving the arm. As time passed (15 minutes), the warm feeling flowed to my should and left side of my back. Another 15 min passed, and it moved down my left leg and knee, which started to hurt. Then got neck got warm and stiff, and I felt the warm feeling got to the left side of my brain. 15 minutes passed left side of the face got warm. And then it headed to my lips and then tongue. Lips got numb, and tongue got numb. 5 minutes pass and my tongue and
45 2021-04-28 swelling Swelling, Tenderness, Redness that continues to spread up and around arm 2 days after vaccine.
45 2021-04-29 lymph node swelling Little bit of a sore arm the day of and the day after. But the third day i had a very swollen lymph ... Read more
Little bit of a sore arm the day of and the day after. But the third day i had a very swollen lymph node in my right arm pit.
45 2021-04-29 lymph node swelling Nodule in the lymphatic area and it is permanent with a lot of pain.
45 2021-04-29 swelling face 12/21/20 Patient presents in ED with ? Allergic Reaction Triage Note: Pt to ED for allergic reactio... Read more
12/21/20 Patient presents in ED with ? Allergic Reaction Triage Note: Pt to ED for allergic reaction. Pt had Covid-19 vaccine around 1530. Pt then developed rash, itchiness, and facial swelling. Pt took Po Benadryl. At this time, pt is Aox4. Denies SOB. Pt reports her symptoms have resolved. 12/28/2020 - Headache Congestion or running nose
45 2021-04-29 swelling Patient experienced perioral tingling and swelling after dose #1. Experiencing tingling few minutes ... Read more
Patient experienced perioral tingling and swelling after dose #1. Experiencing tingling few minutes After administration of dose # 2 today. Benadryl 25mg PO administered. Monitored for 15 minutes. Denies any trouble swallowing, SOB, or swelling. Patient was discharged home
45 2021-05-02 lymph node swelling Burning and tingling down arm right away. 7 hours later back ache, arm pain, burned when I touched i... Read more
Burning and tingling down arm right away. 7 hours later back ache, arm pain, burned when I touched it, 24-60 hours later burning scalp on opposite side of injection, severe back pain, burning in left shin. 2 weeks after back pain still, severe hand joint pain. 3 weeks later severe knee joint pain swollen lymph nodes on right side on and off still.
45 2021-05-02 swelling swelling and redness of rt 4th toe. -- suspect chilblains worsening psoriasis
45 2021-05-02 swelling About 16 hours after 2nd Dose of Pfizer COVID-19 vaccine, patient developed swelling, extreme discom... Read more
About 16 hours after 2nd Dose of Pfizer COVID-19 vaccine, patient developed swelling, extreme discomfort, and partial loss of motion in left arm where injection was administered. Vaccine appears to have aggravated local inflammation from a pre-existing clavicle dislocation. Original clavicle dislocation possibly coincidental with Pzizer first dose (lot EP7533) in same arm.
45 2021-05-03 peripheral swelling Approximately two hours after vaccine rash on lower legs then feet and ankles began to swell. Comp... Read more
Approximately two hours after vaccine rash on lower legs then feet and ankles began to swell. Complained of difficulty walking due to swelling.
45 2021-05-04 c-reactive protein increased MODERATE PAIN STARTED IN LEFT ARM AT INJECTION SITE WITHIN 4.5 DAYS OF VACCINE BEING ADMINISTERED. P... Read more
MODERATE PAIN STARTED IN LEFT ARM AT INJECTION SITE WITHIN 4.5 DAYS OF VACCINE BEING ADMINISTERED. PAIN PROGRESSIVELY WORSENED OVER THE NEXT TWO DAYS, TRAVELLING UP THE ARM TO THE LEFT SHOULDER AREA AND UP TO THE BASE OF THE NECK. BY APRIL 26, 2021 (ONE WEEK AFTER VACCINE ADMINISTRATION), I COULD NO LONGER MOVE MY LEFT ARM, MY RANGE OF MOTION WAS SEVERELY IMPACTED AND PAIN WAS INTENSE (I COULD NOT SLEEP OR FUNCTION NORMALLY). I VISITED DR. ON TUESDAY, APRIL 27, AND SHE PRESCRIBED CYCLOBENZAPRINE, A MUSCLE RELAXANT FOR THE PAIN. X-RAYS WERE TAKEN OF MY LEFT SHOULDER AND CERVICAL SPINE. THE PAIN PERSISTED FOR ANOTHER WEEK, UNTIL APPROX. MONDAY MAY 3, 2021 (WHILE STILL TAKING CYCLOBENZAPRINE).
45 2021-05-04 swelling face, peripheral swelling Bells Palsy on right side of face; Severe rash on hands, trunk, neck; large blister like bumps on ha... Read more
Bells Palsy on right side of face; Severe rash on hands, trunk, neck; large blister like bumps on hands, trunk and head: itching; itching; facial swelling/ swelling in face; hand swelling/ swelling in hands; tingling in lips; some mild difficulty swallowing; throat swelling; mild difficulty breathing; numbness; swelling in mouth; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 06Apr2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose on 05Feb2021 15:00 (lot: EN6201) and second dose on 25Feb2021 15:00 (lot: EN6205); both via an unspecified route of administration in left arm (at the age of 45-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a public health department. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient have not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. Medical history included known allergies Sulfa, bee stings, shellfish and Ceclor. Concomitant medications included armodafinil; clonazepam; vortioxetine hydrobromide (TRINTELLIX), also Tooo Max and an unspecified vit. The patient experienced Bells Palsy on right side of face; throat swelling; itching; mild difficulty breathing; severe rash on hands, trunk, neck; numbness; swelling in mouth; large blister like bumps on hands, trunk and head: itching; facial swelling/ swelling in face; hand swelling/swelling in hands; tingling in lips; some mild difficulty swallowing on 02Mar2021 at 15:00. The patient considered the case as non-serious, did not result in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and non-congenital anomaly/birth defect. The events resulted doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received prednisone, cetirizine hydrochloride (ZYRTEC), omeprazole (PRILOSEC), methylprednisolone sodium succinate (SOLU-MEDRO) IV at ER as treatment. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-05-05 lymph node swelling, lymph node pain Severe headache, chills, nausea, sore arm from wrist all the way to base of skull on left side. Swo... Read more
Severe headache, chills, nausea, sore arm from wrist all the way to base of skull on left side. Swollen and very sore lymph nodes in armpit.
45 2021-05-05 lymph node swelling Pfizer-BioNTech COVID-19 Vaccine EUA Patient reported swelling of her Lymph nodes under the armpit o... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Patient reported swelling of her Lymph nodes under the armpit of the vaccinated arm as a reaction to a previous influenza vaccine. She was told she must be monitored at the pharmacy for at least 30 minutes after the Pfizer COVID-19 vaccination and she agreed. No symptoms were present on the day of the vaccination to COVID. Two days after the vaccination on 4/19/2021 she called the pharmacy and explained to me she had a reaction to the COVID vaccination. The reaction was noted as very similar to her previous reaction to an influenza vaccination. She described it as swelling of her lymph node under the armpit of her vaccinated arm. The circumference was that of a lemon. The depth was described as pronounced and significant but not large enough to impede arm motion. The patient called me back as a follow-up request 4/20/21 and stated the eruption had gone down a little but it was still present. On 4/23/21 she stated the eruption was the same size as her report on 4/20/21 and that there was no longer any discomfort in the affected area. She called back on the day all symptoms had resolved, which was 4/28/2021. I recommended she not get the 2nd Pfizer vaccine without being supervised in a facility with emergency equipment at hand.
45 2021-05-06 lymph node swelling I received the pfizer vaccine on May 6 2021 around 430pm. I woke up this morning with swelling right... Read more
I received the pfizer vaccine on May 6 2021 around 430pm. I woke up this morning with swelling right above my left collar bone / neck area. I can feel a small ball / lump in the area
45 2021-05-06 white blood cell count increased All Covid symptoms returned. Tremors. Severe headache. Numbness in right side of face and body. Dizz... Read more
All Covid symptoms returned. Tremors. Severe headache. Numbness in right side of face and body. Dizzy. New was throat swell and tongue swelling.
45 2021-05-07 lymph node swelling This is a spontaneous report from a contactable other health professional (patient). A 45-year-old n... Read more
This is a spontaneous report from a contactable other health professional (patient). A 45-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration in right arm on 06Feb2021 09:30 as single dose for covid-19 immunisation. Medical history included asthma and allergies, known allergies were Latex and bees. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), reported as advir 500/50; bupropion hydrochloride (WELLBUTRIN); levocetirizine dihydrochloride (XYZAL) and BP medication, all concomitants were taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included first dose of BNT162B2 via an unspecified route of administration, administered in right arm on 23Jan2021 09:30 (Batch/Lot Number: EK9231) for covid-19 immunisation. On 07Feb2021 01:00, the patient experienced major headache, body ache, fever, nausea and swollen lymph nodes. No other vaccine in four weeks.
45 2021-05-09 lymph node pain, lymph node swelling Within minutes, I experienced tachycardia and syncope with weakness. After 30+ minutes, they clear... Read more
Within minutes, I experienced tachycardia and syncope with weakness. After 30+ minutes, they cleared me to go home with no intervention. My heart rate had come down and though still weak they felt I was ok. Hives began within this period and worsened after my release. Nausea and dizziness within the hour which persisted for 5 days with fevers, chills and sweats, until diarrhea became the predominant stomach ache. Through the first three days, chest pain and weakness continued with the dizziness, fevers and nausea. Metallic taste in mouth. Blister on roof of mouth. Lymph node swelling under arm within a day or so, and into the neck by day 6. Very tender. Fevers continue but low grade and without chills or sweats. Right eye pain beginning first night -continuing still. Episodic hives first several days. Joint pain, nerve pain, muscle pain. Bright red joints and tendons episodically.
45 2021-05-09 lymph node pain Commencing at 7:00 pm on vaccination date numbness in mouth and metallic taste, nausea, dizziness. A... Read more
Commencing at 7:00 pm on vaccination date numbness in mouth and metallic taste, nausea, dizziness. At approximately 9:00 pm extreme headache, extreme nausea, excruciating pain at injection site spreading down to hand. Threw up repeatedly. Temperature of 102. Chills and shaking , pain in lymphnodes, unable to arise from prone position. Diarrhea commenced around 1:00 am. Major symptoms subsided by noon following day and by 7:00 pm symptoms largely resolved. Had Covid in March 2020 no test as not available at time. Tested positive for antibodies for several months. ER visit in May 2020 severe inflammation and pain during menstration. Had to have hysterectomy on March 9,2021. Daughter in ER week after me with alleged HSP but confident she had MIS-C. I am Rh negative. I truly hope this helps with future care for others.
45 2021-05-09 peripheral swelling Left leg numb swollen from thigh down to my feet and aching the whole leg however mostly in my knee.
45 2021-05-09 white blood cell count increased, lymph node swelling, c-reactive protein increased Pt presented to Urgent Care on the third day after vaccine (5/9) with chest pain, left arm pain, nau... Read more
Pt presented to Urgent Care on the third day after vaccine (5/9) with chest pain, left arm pain, nausea and vomiting. EKG showed T-wave inversion on V2 and pt was sent to the ED for further evaluation. At the ED, bloodwork showed a significantly elevated troponin level. Pt was admitted for a possible NSTEMI and placed on a heparin gtt, diagnosis changed to myocardial injury within the setting of myo/pericarditis.
45 2021-05-10 lymph node pain 4/3/21 - hives on right thigh, 4/5/21 extreme fatigue, 4/6/21 flu-like symptoms, 4/7/21 arms and leg... Read more
4/3/21 - hives on right thigh, 4/5/21 extreme fatigue, 4/6/21 flu-like symptoms, 4/7/21 arms and legs weakness and pain progressively got worse through 4/16/21 when mobility started decreasing, 4/19/21 fatigue, flu-like pain, lymph nodes sore, arms heavy & weak, 4/20/21 slight feverish feeling but no fever, throat sore, strange smell, nasal congestion, 4/20 COVID test negative 12:10pm at Urgent Care, 4/21 lungs burning, bronchitis, laryngitis, waves of feverish feeing with no fever, pain subsided but fatigue came back, 4/23 cold better but arms and legs painful heavy, 4/24 1pm extreme fatigue, arms and legs weak, can't walk or move, 4/25-5/7/21 Arms and legs like lead, extreme pain and weakness, burning feeling on legs, twitching crawling sensations, buzzing all over, hiccups, hearing loss, cannot walk or move arms much, had to crawl to the bathroom, only arms and legs affected, middle of body and head/brain was totally fine, prickly feeling on ankles, pins and needles on feet, burning and gnawing pain, layers of different kinds of pain, 4/27 pain started moving up to thigh from lower extremities to higher extremities (calf to thigh, wrist to upper arm), all over body throb (present throughout), 5/9 feeling better more able to walk, sharp pinching pain in left front thigh and right side calf, 5/10 right calf pain went away, left thigh more painful, visible dark spot on thigh, worried this is a clot, feeling of pinching pain.
45 2021-05-10 lymph node swelling Dose 1 - Fatigue and headaches that lasted around 3 days. Dose 2 - I had brain fog, dizziness and f... Read more
Dose 1 - Fatigue and headaches that lasted around 3 days. Dose 2 - I had brain fog, dizziness and fatigue. Over the weekend, I was still more tired than usual. By Monday, I was wiped out. I had severe brain fog and had to leave work because I couldn't focus on my patients. I also experienced a sore throat and swollen lymph nodes. I was in bed all day Monday and Tuesday due to severe fatigue. It gradually increased, but didn't completely resolved until about 3 weeks later.
45 2021-05-10 lymph node swelling Supraclavicular and axillary lymphadenopathy
45 2021-05-10 swelling Given Benadryl 25 mg PO pre-vaccination per provider. Patient had hives, swelling and tightness in t... Read more
Given Benadryl 25 mg PO pre-vaccination per provider. Patient had hives, swelling and tightness in throat approximately 25 min after dose. Given Benadryl 25mg PO after dose. First vaccine: had hives/rash down arms/back 15 minutes after receiving vaccine. Stable, though continued to have "scratchy throat", released from vaccination site.
45 2021-05-10 swelling Injection site pain Injection site lump, bump & swelling Injection site redness Injection site itchi... Read more
Injection site pain Injection site lump, bump & swelling Injection site redness Injection site itching Headache Dizziness Fatigue for 24 hours
45 2021-05-11 anaphylactic reaction Anaphylaxis Metal taste in mouth Numbing of face and lips
45 2021-05-12 lymph node swelling This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient (n... Read more
This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Feb2021 11:45 (Batch/Lot Number: EL3247) at the age of 45-year-old, as single dose for COVID-19 immunisation. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number EL3247) on 20Jan2021. Medical history included food allergy from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norelgestromin (XULANE) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity. The patient experienced within 6 hours of vaccination my tongue started to hurt (sides and underside) and a few sores developed on right side of my tongue (glossodynia) (non-serious) on 10Feb2021 17:30 with outcome of recovering, my tongue are scalloped in appearance (tongue disorder) (non-serious) on 10Feb2021 17:30 with outcome of recovering , glands in my neck are also sore/inflamed (lymphadenopathy) (non-serious) on 10Feb2021 17:30 with outcome of recovering.
45 2021-05-13 lymph node pain Itching at injection site starting around 2 hours after vaccination. Pain along lymph nodes in left ... Read more
Itching at injection site starting around 2 hours after vaccination. Pain along lymph nodes in left side. 5/14 awoke to intense itching and approx 2? in diameter eased warm welt on top of tennis ball size knot at injection site. Also included is pain in major joints.
45 2021-05-13 lymph node swelling Numbness in fingers, Lymph nodes swollen, chest and underarm pain, feverish -after 2 weeks
45 2021-05-13 lymph node swelling High fever started about 10-12 hours after vaccine; ringing in ears; aches; left armpit lymph node i... Read more
High fever started about 10-12 hours after vaccine; ringing in ears; aches; left armpit lymph node is huge, looks like a ping pong ball; This is a spontaneous report from a contactable consumer, the patient. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 02Apr2021 at 15:00 (Batch/Lot Number: ER8734) as a single dose (at the age of 45-years-old) for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID); nebivolol hydrochloride (MAXINEB); and vitamin d5 (VITAMIN D5); all from unknown dates taken for an unspecified indications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 03Apr2021 at 02:30 the patient experienced high fever, ringing in ears, aches and left armpit lymph node is huge. The patient stated high fever started about 10-12 hours after vaccine, ringing in ears (continued into day 3), aches and left armpit lymph node is huge, looks like a ping pong ball (very painful). The events were reported as non-serious and did not require hospitalization or prolongation of hospitalization. The patient did not receive any therapeutic intervention for events high fever, ringing in ears, aches and left armpit lymph node is huge. The patient underwent lab tests and procedures which Covid test (nasal swab) on 03Jan2021 with result: negative. It was also reported that since the vaccination, has the patient been tested for COVID-19 on an unknown date with unknown results. The clinical outcome of the events high fever, ringing in ears, aches and left armpit lymph node is huge was recovered with sequelae (reported as lasting effects) on unknown dates in 2021. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 23Apr2021 at 14:15 (Batch/Lot Number: EE0152) as a single dose for COVID-19 immunization. Information on Lot/Batch number was available. Additional information has been requested.
45 2021-05-16 swelling Swelling, stiffness, rash, itching and pain in hands and feet. Follow-up itching all over body.
45 2021-05-19 lymph node swelling SWOLLEN LEFT ARMPIT AND UPPER LEFT BREAST TISSUE
45 2021-05-20 lymph node swelling, swelling Patient described swelling in armpits/lymph nodes on side of vaccination a few days following vaccin... Read more
Patient described swelling in armpits/lymph nodes on side of vaccination a few days following vaccination. She also reported neck swelling, should pain. She reported no fever but body aches/chills for about 2 weeks. Patient had to go to urgent care to start steroid dose pack and muscle relaxer to help with pain/inflammation.
45 2021-05-24 swollen extremities The next morning after my vaccine my arm starting twitching and then swelling under my armpit. I to... Read more
The next morning after my vaccine my arm starting twitching and then swelling under my armpit. I took Tylenol. I couldn't sleep on that side it was very uncomfortable. I called my doctor, he said to take motion. I felt better after taking the motrin.
45 2021-05-24 swelling face Face got swollen and I continue to experience sudden swelling of face, discharge/clotting when not o... Read more
Face got swollen and I continue to experience sudden swelling of face, discharge/clotting when not on menstrual cycle, dizzy spells, fatigue, headaches/migraines ongoing, shortness of breathe.
45 2021-05-25 swelling Her feet turned into giant whelps; Hives/hives started out on her feet and arms, and now they are ta... Read more
Her feet turned into giant whelps; Hives/hives started out on her feet and arms, and now they are taking over her entire body; She was having a hard time walking; They are painful; This is a spontaneous report received from a contactable consumer (patient herself). A 45-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 30Mar2021 09:00 (Lot Number: ER8733, at age of 45 years old) as single dose for COVID-19 immunisation. Medical history included she had always had bad allergies. She thought it was just an immune, Compromised immune status, Respiratory illness, Chromosomal abnormalities, diabetes, obesity, Seasonal allergies diagnosed when she was 5 years old, interstitial cystitis diagnosed a few years ago. The patient's concomitant medications were not reported. The patient previously Intramuscularly received first dose of BNT162B2 on 09Mar2021 for Covid-19 immunization, lot: EN6206; anatomical location: Left arm; Time the vaccination was given: 09:00. The patient developed hives on 07Apr2021, 5 days after receiving the second dose of the Pfizer Covid 19 vaccine. They had been going on for 6 weeks and weren't going away despite being on prednisone. Her doctor said there was no life threatening issue. She said they were painful, annoying and she couldn't work out or participate with her family like she wanted. She developed hives and was put on 60 mg of Prednisone to control. They started 5 days after the second dose of the vaccine and have not gone away. There was no prescriber. Her family recommended she did something. She would be seeing an allergist. She said Prednisone was a hell of a drug to be on. After second dose, she was told to do light exercise to move her arm. She did not have any fatigue. She was working out and 5 days later, she got the hives. The hives started out on her feet and arms, and now they were taking over her entire body. She was having a hard time walking because the ones in her feet turned into giant whelps. She could not put on shoes. She had to go to the ER to try and control them. She was already on Prednisone and her time was up and they came back worse. They put her back on it. She might have to take a pill for the rest of her life. They were not going away. The first Prednisone was 20mg and she was taking it twice daily for 5 days. She did not have a lot or expiration as she had disposed of it and it was in a pharmacy vial. The start date of the current Prednisone was 02May2021. The current dose was 10mg. She was taking it 6 times a day and was now taking twice a day. It was in a pharmacy vial with no lot or expiration. The count size of the 20 mg was unknown. The count size of the 10 mg is 57. She would not be willing to send a sample. ER or physician's office required at the Urgent Care. She went to that urgent care twice. The first time they said to ride it out. The second time, they prescribed Prednisone. She finished it and was on vacation and got them again. She had to go to the ER to get more Prednisone because they covered her entire body. It was very scary to have a new thing and thinking body was attacking itself. The outcome of hives giant and hives was not recovered, the outcome of rest events was unknown. Information on Lot/Batch number was available. Additional information had been requested.
45 2021-05-25 lymph node swelling Mild muscle soreness around injection site; Swollen lymph nodes in left armpit; Hives at major joint... Read more
Mild muscle soreness around injection site; Swollen lymph nodes in left armpit; Hives at major joints.; Severe fatigue day of, for about 24 hrs.; This is a spontaneous report from a contactable patient. A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Batch number: EN6208) via an unspecified route of administration in left arm on 10Mar2021 (at the age of 45-years-old), as an unspecified single dose for COVID-19 Immunisation. The patient's medical history included G6pd enzyme deficient, diabetes mellitus. The concomitant medication included Lisinopril, Pioglitazone. The patient was allergic to Sulpha drugs, NSAIDs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient experienced Mild muscle soreness around injection site, severe fatigue day of, for about 24 hours on an unspecified date. On 15Mar2021, five days later broke out in hives at major joints/lymph node areas that went away after about 8-10 hours. The patient also experienced swollen lymph nodes in left armpit on an unspecified date. The clinical outcome of the event muscle soreness around injection site, swollen lymph nodes in left armpit was unknown, fatigue, hives at major joints/lymph node was recovered. No follow-up attempts are possible; No further information is expected.
45 2021-05-27 lymph node swelling Sore arm the night of the vaccine. Progressed to sore arm, neck and left side of body throughout th... Read more
Sore arm the night of the vaccine. Progressed to sore arm, neck and left side of body throughout the night. Sunday afternoon I could feel a lymph node in the left side of my neck had swollen. Sunday night I started feeling sensitivity in my left jaw and teeth which progressed to my entire mouth the next day (Monday). Tuesday the sensitivity was only in the right side of my mouth. The right side of my mouth, especially my teeth hurt and is extremely sensitive when I drink and eat anything.
45 2021-05-28 lymph node pain, lymph node swelling Lump near my collar bone/ swollen lymph node; Lump is painful to touch; This is a spontaneous report... Read more
Lump near my collar bone/ swollen lymph node; Lump is painful to touch; This is a spontaneous report from a non-contactable consumer (patient herself). A 45-years-old not-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el3247) via an unspecified route of administration, administered in arm left on 27Jan2021 at 08:15 as 1ST DOSE, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Medical history included prediabetic and lymphedema in right foot. No allergies to medications, food, or other products were reported. Concomitant medications included daily multivitamin. On 02Feb2021 at 08:30 AM, six days after receiving the Covid-19 vaccine, she developed a lump near her collar bone. Lump was painful to touch. She reached out to her doctor, but they were unavailable due to a snow storm in our area. She believed it was a swollen lymph node. Patient has not been tested for COVID-19 since the vaccination. It was unknown if the patient received treatment for the adverse event. The case was considered as non-serious as per reporter. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
45 2021-05-31 lymph node swelling Swollen lymph node under right arm (injection)
45 2021-06-01 lymph node swelling Bumps on lips after both injections (cold sores) Given Valacyclovir and Acyclovir - Cleared after 7... Read more
Bumps on lips after both injections (cold sores) Given Valacyclovir and Acyclovir - Cleared after 7 day treatment Left Breast Indentation/Hardness/Separation/tenderness - Sent for Mammogram/Ultrasound - Nothing showed on either test except swollen lymph nodes - return in 3 months for recheck. Symptoms ongoing. Other symptoms include more common sore arm, chills, rash arm, swollen lymph nodes, numbness, fatigue, headaches.
45 2021-06-03 peripheral swelling swelling in left armpit; tightness in chest and around upper rib cage; dry cough; Fever 102.3; pain ... Read more
swelling in left armpit; tightness in chest and around upper rib cage; dry cough; Fever 102.3; pain at injection site; severe joint and muscle pain; chills; severe joint and muscle pain; This is a spontaneous report from a contactable consumer or other non-health care professional. A 45-year-old female consumer (non-pregnant Patient) started to receive second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN 600) via an unspecified route of administration and administered in left arm on 02Mar2021 16:15 as second dose, single dose for COVID-19 immunization. Medical history included Beta thalassemia minor. The patient concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration, administered in left arm on 13Feb2021 16:15 as 1st dose, single dose for COVID-19 immunization. The patient did not experience COVID-19 prior vaccination and not tested for Covid-19 and no known allergies. On 03Mar2021 patient experienced fever 102.3 severe joint and muscle pain, chills, swelling in left armpit, pain at injection site, tightness in chest and around upper rib cage. After 36 hours, all symptoms but chest tightness and dry cough subsided. Now at more than 48 hours post vaccine, chest tightness and dry cough remain. The patient underwent lab tests and procedures which included pyrexia: 102.3 on 03Mar2021. The patient did not receive any treatment for events, no other vaccination in other four weeks and no other medication in 2 weeks. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
45 2021-06-06 anaphylactic reaction During our event today, here at the Church in coordination with the Cleaning Services monthly train... Read more
During our event today, here at the Church in coordination with the Cleaning Services monthly training event, a patient had an anaphylactic reaction to the COVID vaccine. Anaphylaxis: 45yoF w/ h/o Rheumatoid arthritis and Wegener?s granulomatosis who takes immunosuppressive infusion 2x/yr, most recently in April, no h/o anxiety, and h/o COVID x2 (4/2020 & 10/2020), experienced an anaphylactic reaction, with symptom onset beginning within 1 min of us administering a 1st dose of the Pfizer-BioNTech COVID vaccine. Sx: throat clearing, cough, chest tightness, diaphoresis PEx: Alert throughout Hand over chest/ lower throat Shortness of breath Voice hoarse, speaking in 1-2 word sentence fragments Timeline: 10:35 - administered 10:36 - throat clearing 10:37 - advising pt to sign up for V-safe given her underlying autoimmune dz 10:38 - intermittent coughs 10:41 - drawing up epi 10:45 - Epi 0.5ml (1mg/ml) administered IM 10:46 - Called 911 for EMS 10:50 - Epi 0.5ml (1mg/ml) administered IM 10:55 - Diphenhydramine 50mg IM 10:57 - Pt notes throat feels more released from prior tightness 11:01 - EMS arrived, began evaluating patient 11:25 - Patient walked out to car, sister drove her home. Advised sister for her or their dad (at home) to stay with/watch the patient for at least the next 3 hours, to be sure angioedema does not worsen; I?m happy to giver pt her 2nd dose on the return date, but recommend if she gets it, best to get while in a hospital setting; to discuss whether or not to get 2nd dose with her Rheumatologist, especially given her prior COVID illnesses x2, making this her immune system?s 3rd exposure; consider getting Epi pen to carry with her for future. Following up with pt to advise her against getting an mRNA vaccine in the future, that currently the only other option in the U.S. is the Janssen/J&J vaccine, and that given her autoimmune disease, I would be concerned about her developing immune thrombosis and thrombocytopenia, so recommend she discuss with her rheumatologist, and that if she gets a subsequent dose of any COVID vaccine, to have it administered at a hospital location.
45 2021-06-06 lymph node swelling, peripheral swelling, swelling Severe Swelling in my left hand, elbow, armpit, groin, and knee that has lasted 2 months and not ye... Read more
Severe Swelling in my left hand, elbow, armpit, groin, and knee that has lasted 2 months and not yet resolved.
45 2021-06-06 peripheral swelling Swelling in my lower body- legs swelled so much, my knees disappeared.
45 2021-06-07 lymph node swelling lymphs inflamed body aches, arms, stomach and groin
45 2021-06-12 c-reactive protein increased 5 days post dose 2 I began to suffer from fatigue combined with symptoms of sinus infection. The fat... Read more
5 days post dose 2 I began to suffer from fatigue combined with symptoms of sinus infection. The fatigue worsened while the other symptoms remained static (minor sore throat, dry cough, clear nose). Fatigue continued for weeks. Finally realized I needed to see a doctor -- that I was not actually sick with COVID-19 or sinus infection. First doctor appointment was on 5/18/2021. Fatigue appears to have been caused by liver issue. Results below.
45 2021-06-13 peripheral swelling, lymph node swelling pt states that her lymph nodes swelled, she states 2 lymph nodes were swollen and caused swelling fr... Read more
pt states that her lymph nodes swelled, she states 2 lymph nodes were swollen and caused swelling from her shoulder to elbow. She also states she had a fever of 102 degrees that lasted for 2 days. she received her shot Friday around 5:15pm and had fever the next day during the day. She said the Saturday night the swelling occurred causing her to go to the emergency room for treatment. They treated her and she is recovered now but was advised by the emergency room that this was a systematic reaction and to have the pharmacy report it to vaers
45 2021-06-13 swelling face I got the 2nd dose, I went and sat down my heart was racing and I was breathing funny. The side were... Read more
I got the 2nd dose, I went and sat down my heart was racing and I was breathing funny. The side were I got the shot my muscles felt like it was moving and my face started to droop and was swelling. The rushed me to the er and they gave me an cocktail for my reaction and they said that I passed out. It was like I went to sleep and and woke up with a disability. I have muscle spams in my face, I could feed myself my daughter had to feed me. They told me that it was bells palsy. they gave me pretonze and stomach meds to treat it. They told me they wouldn't take my case since the vaccine was voluntary. They gave me muscles relaxer but it was messing with my heart. It took me until march till I was normal but I still have the fast blinking and lock in my mouth . I also had a seizure a month later.
45 2021-06-15 lymph node swelling Swollen lymph nodes in bilateral arm pits; pain in bilateral armpits that radiates to breasts, upper... Read more
Swollen lymph nodes in bilateral arm pits; pain in bilateral armpits that radiates to breasts, upper arms, and down both sides; pain in bilateral armpits that radiates to breasts, upper arms, and down both sides; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9231), via an unspecified route of administration, administered in left arm on 05Jan2021 at 05:00 PM (at the age of 45 years old), at second dose, single dose for COVID-19 immunisation. The patient was not pregnant upon vaccination. Medical history included autoimmune disorder. The patient didn't have COVID-19 prior to vaccination and was not tested for COVID post vaccination. The patient was tested for autoimmune more than 10 years ago, but never received a firm diagnosis. Concomitant medications included famotidine (PEPCID AC) and calcium carbonate (TUMS ANTACID). Past drug events included allergy in etodolac (LODINE). The patient was previously administered the first dose of BNT162B2 (Lot number: EH9899) in right arm, on 15Dec2020 (at the age of 45 years) for COVID-19 immunisation. On 06Jan2021, 05:00 PM, the patient experienced swollen lymph nodes in bilateral arm pits 24 hours after the second vaccination. She also had severe pain and tenderness in bilateral armpits radiating into breasts and down sides for one week. Still continuing to have daily pain in bilateral armpits that radiates to breasts, upper arms, and down both sides often requiring ibuprofen. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
45 2021-06-16 axillary mass I received my last Pfizer vaccine on April 26th. After the first shot, I was tired, my arm hurt and ... Read more
I received my last Pfizer vaccine on April 26th. After the first shot, I was tired, my arm hurt and I noticed that I my hips were aching when walked up the stairs. Not a big deal. The second shot however was a different story. Probably about a week and a half after my second shot, these painful lumps started forming in my arm pits. They were huge and pointy. I can still see the bruises from where they were poking out of my skin. The doctor said they were a side effect from the vaccine and it would take time. I was sluggish and in pain for over a month. Memorial Day was on May 31st and I could't play corn hole because throwing the bean bag was painful and my skin was raw because I had to put bandaids over the lumps when cycling reduce the friction. I finally feel like I am back to normal and I don't know how I feel about getting the vaccine again.
45 2021-06-16 lymph node swelling lightheaded; Throat constriction; metallic taste in mouth and throat; extremely swollen lymph nodes ... Read more
lightheaded; Throat constriction; metallic taste in mouth and throat; extremely swollen lymph nodes in neck; rash on arms and around ankles; Extreme dizziness; heaviness of head; extreme exhaustion; chills; This is a spontaneous report from a contactable consumer and other healthcare professional. A 45-years old adult female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 04Feb2021 at 07:15 as 1ST DOSE, SINGLE DOSE in left arm for COVID-19 immunization. The patient medical history included vitiligo and migraines and concomitant medication included Aleve. The patient did not take any other vaccine in four weeks. The patient past drug event included Imitrex, Augmentin, and Transderm for Known allergies. It was reported that patient was not tested for COVID prior to vaccination and COVID tested post vaccination. On 04Feb2021 at 11:15, the patient experienced extreme dizziness, lightheaded, throat constriction, metallic taste in mouth and throat, rash on arms and around ankles, heaviness of head, extreme exhaustion, chills, and extremely swollen lymph nodes in neck. The patient underwent laboratory tests and procedures which included covid test (nasal swab) shows negative on 15Feb2021. The patient took antacid as a treatment for the events. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.
45 2021-06-16 lymph node swelling The pain was so severe in her throat and mouth; The pain was so severe in her throat and mouth; alle... Read more
The pain was so severe in her throat and mouth; The pain was so severe in her throat and mouth; allergic reaction; Oesophageal pain; her fatigue has gone; felt like her throat was closing in on her; Swollen lymph nodes; oral thrush, a fungal infection; covid-like symptoms; This is a spontaneous report from a contactable consumer( the Patient, reported for self) A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9262, Expiry date: May2021), via an Intra-muscular route of administration, administered in left arm on 23Jan2021 at 15:45 as a single dose for COVID-19 immunization (preventative) at hospital. Medical history included ongoing anxiety (Additional Information for Other Conditions: diagnosed years ago). Other Relevant Med History was none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available or prior vaccinations were none. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Prior Vaccinations (within 4 weeks) includes: flu shot but she is not sure when. Concomitant medications included buspirone (15mg tablet once a day by mouth) taken for anxiety from an unspecified start date and ongoing. On 30Jan2021, patient experienced COVID- like symptoms. On 31Jan2021, patient experienced Oral thrush. On 01Feb2021, patient experienced Swollen lymph nodes. Reporter stated that She was calling to report an allergic reaction to the first dose of the Pfizer COVID vaccine. Patient was having oral thrush, a fungal infection. In doing her research she has found that multiple people are coming back with the same reaction and it is connected to polyglycerol. Patient heard there was a patch out to see if someone is allergic to polyglycerol. She has been in contact with VAERS, the health department and CDC. Patient stated that she started with COVID-like symptoms on 30Jan2021. Then she had pain from the oral thrush in the bottom of her lower esophagus which then went up to her mid esophagus. Patient was treating with salt water on Monday. She had swollen lymph nodes on Monday. She went to her primary care doctor on 02Feb2021 and she was given a suspension. The pain was so severe in her throat and mouth, she felt like her throat was closing in on her and she was referred to the Emergency Room (ER). Patient went to ER on 03Feb2021. She confirms she was not admitted to the hospital. She called her dentist on 03Feb2021 and they ordered a mouth rinse with lidocaine and the mouth rinse is what started her on the road recovery since it is numbing her throat and mouth. Patient was a teacher. She is scheduled to receive a second dose on 13Feb2021. She is hearing from the research she is reading that the symptoms experienced with the second dose could be up to 3 times as bad as what one would experience from the first dose. Advised to consult with hcp about receiving the second dose. Her school nurse called to ask if a 300 pound person would receive the same dose as a 115 pound person and she was told the same dose would be received. She is asking where this is coming from. Patient was visited to emergency room and physician office for the events. COVID-like symptoms: Patient stated she was in bed for 5 days, her fatigue has gone away since her mouth and throat have started to heal. States this is her first day back working virtually. The outcome of the events was reported as recovering for oral thrush, a fungal infection; Swollen lymph nodes (they were tender not as swollen); Outcome for event fatigue reported as recovered; and unknown for other events. Follow-up (27May2021): Follow-up attempts completed. No further information expected.
45 2021-06-17 lymph node swelling Generalized arm pain after injection, severe fever, chills, brain fog, swollen lymph nodes, severe f... Read more
Generalized arm pain after injection, severe fever, chills, brain fog, swollen lymph nodes, severe fatigue. Symptoms were most severe for 18 hours after shot. Swollen lymph nodes and severe fatigue continued for two weeks post shot.
45 2021-06-17 swollen extremities swelling into armpit, fever, headache, dizziness
45 2021-06-17 peripheral swelling Swelling, soreness, tightness, and redness on my lower left leg, ankle and foot. Started around end... Read more
Swelling, soreness, tightness, and redness on my lower left leg, ankle and foot. Started around end of May and progressively go worse (site/place spread from foot to knee over time).
45 2021-06-18 lymph node inflammation Feeling like she was going to faint many times a day; Really really weak; Dizziness; Feeling pressed... Read more
Feeling like she was going to faint many times a day; Really really weak; Dizziness; Feeling pressed in her chest and head; Feeling pressed in her chest and head; Weak muscles; Lymph nodes were inflamed on her neck; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 20May2021 at 17:00, at the age of 45 years old, as 1st single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Past drug hisory included amoxicillin sodium/clavulanate potassium (AUGMENTIN) and sulpha. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the had never been patient diagnosed with COVID-19. The patient reported feeling really really weak, having dizziness, and feeling like she was going to faint many times a day. She was feeling pressed in her chest and head, and weak muscles, lymph nodes were inflamated on her neck, for 20 days from the vaccination. The onset date of all events was reported as 20May2021 at 17:30. Due to the events the patient visited her doctor and emergency room. She was treated with celecoxib (CELEBRA) and arginina aspartate (SRGENOR FORTE). A polymerase chain reaction/nasal swab for COVID-19 done on 01Jun2021 turned negative. The patient had not recovered from the above mentioned events. Follow-up actions are needed. Further information has been requested.
45 2021-06-20 lymph node swelling, swelling Headache, swelling, neck pain, high temp fever, pneumonia, loss of state and smell, swelling of lymp... Read more
Headache, swelling, neck pain, high temp fever, pneumonia, loss of state and smell, swelling of lymph nodes.
45 2021-06-23 lymph node swelling So I had normal soreness and felt fine the first day and I had some fatigue later that night (like t... Read more
So I had normal soreness and felt fine the first day and I had some fatigue later that night (like the first dose). The next day was even more fatigue and as time went on I started having flu like symptoms like chills, I mean I have joint pain here and there but it wasn't the same. Same with muscular pain, it was just intensified. I had allergic reactions to medications that I normally wasn't allergic to (Cymbalta and Benadryl). I got swollen lymph nodes and still have some. I ended up having diarrhea and a rash and itching because of the allergic reaction to the medications. My skin started breaking out. My balance and concentration was all thrown off with the second dose (it seemed better with the first). This went on and off for 2 weeks. It just lingered, when I thought I was getting better it would come back. I was a bit dizzy and of course my anxiety increased because I couldn't do anything, even get up and eat. It was pretty bad. I'm far better now but still have some of the lingering stuff, like good days and bad days. My first doctor's appointment was a telehealth and I couldn't get an in office visit until 6/23.
45 2021-06-23 lymph node swelling Shortly after the shot itching all over began, with no hives. About 15 minutes after the dose, star... Read more
Shortly after the shot itching all over began, with no hives. About 15 minutes after the dose, started with racing heart rate, shortness of breath, dizziness and near syncope, weakness, nausea. Then started with 30 minutes of legs spasming/trembling. Ears, throat, tongue itching and wheezing. No treatment administered by the facility. I used my own inhaler for the wheezing. Was then largely fine for about 6 hours at which time arm soreness began, following by fever, sweats, chills, exhaustion, nausea, lymph node swelling, body aches. High fevers and sweats for 36 hours (Did not take over night or through next morning but must have been well over 102 as I felt like I had pneumonia and felt remarkably better and could eat the second evening at which time I could check and it was 102). Already much improved by beginning of third day. Towards the middle/end of week one, however, began with eye pain and increased asthma symptoms, some transient hives periodically, and physically tired. Palpitations and chest pain began late last evening. If it gets like after shot 1, I will seek medical evaluation this time.
45 2021-06-24 bursitis I went to hospital on 06/04/2021. They x-rayed it and wrapped it. I followed up with my rheumatolo... Read more
I went to hospital on 06/04/2021. They x-rayed it and wrapped it. I followed up with my rheumatologist. She put a drain in it but it came back that night. They diagnosed it as olecranon bursitis. All I have on now is a compression wrap.
45 2021-06-24 peripheral swelling, swelling Some of these effects have gotten worse or developed over time; Swelling of the right arm, right sid... Read more
Some of these effects have gotten worse or developed over time; Swelling of the right arm, right side of neck, right shoulder, right side into breast; Swelling of the right arm, right side of neck, right shoulder, right side into breast; Swelling of the right arm, right side of neck, right shoulder, right side into breast; movement decrease; trouble swallowing; pain; This is a spontaneous report from a contactable other hcp/nurse (patient). A 45-years-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1285 and expiry date: unknown) intramuscularly, administered in the right arm on 12Jan2021 15:15, as a single dose for COVID-19 immunization. Medical history included Asthma, Hyperinsulinemia, Hypertension, Obesity and Tachycardia. Known allergies: Lortab and penicillin. Concomitant medications included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), metoprolol (METOPROLOL) and amlodipine (AMLODIPINE). The patient experienced Swelling of the right arm, right side of neck, right shoulder, right side into breast, movement decrease, trouble swallowing at times and pain on 13Jan2021 at 03:00 PM. Some of these effects have gotten worse or developed over time. The patient went to the hospital and got put on a steroid pack (Medrol dose pack) and was told to take Benadryl as well. That was after a week of swelling. However, the patients arm was still swollen and was stiff and hurts to move and lay on. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Jan2021, sars-cov-2 test: negative on 21Jan2021, sars-cov-2 test: negative on 26Jan2021, sars-cov-2 test: negative on 28Jan2021, sars-cov-2 test: negative on 02Feb2021. The clinical outcome of all the events was not recovered. Follow-up attempts are completed. No further information is expected.
45 2021-06-24 swelling neck redness and swelling; neck redness and swelling; Pain; nausea; diarrhea; sore throat; sob; This... Read more
neck redness and swelling; neck redness and swelling; Pain; nausea; diarrhea; sore throat; sob; This is a spontaneous report from a non-contactable Nurse. This 45-year-old female Nurse (patient) reported for herself. A 45-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: En6200, Expiration date: unknown), via unspecified route, administered on 04Mar2021 03:15 AM (at the age of 45-year-old) as Unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not have COVID-19. No Covid tested post vaccination No. On 05Mar2021 (20 hours 45 minutes after the vaccination), the patient experienced pain, nausea, diarrhoea, sore throat, shortness of breath, neck redness and swelling. Atarax, ibuprofen albuterol treatment received . The outcome of the events was recovering. No follow-up attempts possible. No further information expected.
45 2021-06-28 swelling Patient reported significant history of anaphylaxis. Around 40 minutes after receiving vaccine, pati... Read more
Patient reported significant history of anaphylaxis. Around 40 minutes after receiving vaccine, patient appeared anxious, her throat felt itchy and she felt her lips/tongue were "puffy and numb". Vital signs stable. Patient stated "this is how she feels before having an allergic reaction". Patient was given adult dose of epipen around 12:28pm. A rapid response was called in the clinic and several staff arrived for assistance. Clinic doctor assessed the patient for worsening symptoms. Vital signs remained stable after epipen administration. Report given to two paramedics who transferred patient to the nearest hospital for further evaluation.
45 2021-06-29 lymph node swelling 6/4 I had mild headache, fever, sleepiness, 6/5 woke up to swollen lymph node in left armpit, 6/6 wo... Read more
6/4 I had mild headache, fever, sleepiness, 6/5 woke up to swollen lymph node in left armpit, 6/6 woke up to pain in injection site with red circle. "COVID arm lasted only 2 days, but Swollen lymph node about 2+ weeks. On 6/7 started feeling random intermittent numbness and tingling in arms, legs, face and heat sensations in back chest and abdomen. Mind feels foggy, some vertigo feelings. Got more intense by 6/9 and got scared to went to ER. Urine and blood results didnt show anything bad so Dr. diagnosed as paresthesia. Symptoms have bot gone away and started feeling heat and head pressures top/back of head that comes and goes. Went to Dr. he thinks I have anxiety which is likely true, but I cannot get the head pressures to subside. I still feel foggy and like my body is trying to fight off an infection of some sort
45 2021-06-29 peripheral swelling, lymph node swelling STARTED WITH FEVER AND THEN LYMP NODES ENLARGED ON L ARM PIT ,2 DAYS LATER MOVED TO R ARM PIT AFTER... Read more
STARTED WITH FEVER AND THEN LYMP NODES ENLARGED ON L ARM PIT ,2 DAYS LATER MOVED TO R ARM PIT AFTER A WEEK R LEG SWOLLEN BELOW THE KNEE AND MOVED TO THE LOWER LEG. WITH LOTS OF PAIN AT THE KNEE
45 2021-06-29 peripheral swelling Allergic reaction; extreme itchy; hives; swollen hands; This is a spontaneous report from a contacta... Read more
Allergic reaction; extreme itchy; hives; swollen hands; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via unspecified route of administration on the left arm on 19Mar2021 at 03.45 pm (at the age of 45-years-old) as a single dose for COVID-19 vaccination. The patient had no relevant past medical history. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient developed allergic reaction which was extreme itchy, hives and swollen hands and feet. Therapeutic measure included the use of BENADRYL for the treatment of the adverse events. The clinical outcome of the event allergic reaction involving events itchy hives, swollen hands and feet was recovering at the time of report. No follow-up attempts are possible. Information about lot number cannot be obtained.
45 2021-07-02 swelling headache; lightheaded and getting worse; lightheaded and getting worse; my lips were tingling; my ch... Read more
headache; lightheaded and getting worse; lightheaded and getting worse; my lips were tingling; my cheeks, then my tongue, my checks got red and a bit swollen; breathing started to feel weird; breathing started to feel weird; This is a spontaneous report from a contactable consumer or other non hcp. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 15:00 (at the age of 45-years-old) (Batch/Lot Number: EN6208) as Dose 1, Single for Covid-19 immunisation. Medical history included fibromyalgia, hypertension, vertigo, food allergy allergies tamiflu, meloxicam, coke, chocolate, food allergy from an unknown date. Concomitant medications included Montelukast, fexofenadine hydrochloride (ALLEGRA), Olmesartan, zinc taken for an unspecified indication, start and stop date were not reported. The patient previously took tamiflu and experienced drug hypersensitivity, meloxicam and experienced drug hypersensitivity.Treatment medication includes benadryl, methylprednisolone IV, Pepcid, metoclopr. On 17Mar2021 15:15 the patient experienced after 10 min, got a headache, then felt lightheaded and getting worse every minute, then my lips were tingling, then my cheeks, then my tongue, my checks got red and a bit swollen, then my breathing started to feel weird. At this point I agreed to go on rescued. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measures were taken as a result of headache (headache), lightheaded and getting worse (dizziness), lightheaded and getting worse (condition aggravated), my lips were tingling (paraesthesia oral), my cheeks, then my tongue, my checks got red and a bit swollen (swelling), breathing started to feel weird (respiration abnormal), breathing started to feel weird (feeling abnormal). Events were considered as medically significant. Outcome of events were resolved on unspecified date in 2021 with no sequels. Follow-up attempts are completed. No further information is expected.
45 2021-07-05 peripheral swelling The day after receiving the COVID19 shot (upper left arm), I experienced swelling with a dull, insis... Read more
The day after receiving the COVID19 shot (upper left arm), I experienced swelling with a dull, insistent pain that seemingly moves down the back of my arm to my elbow and forearm and will occasionally cause the back of my hand and fingers to tingle or go numb. While the swelling went down within 3 days, the uncomfortable pains have persisted and somewhat worsened. I occasionally will feel a slight pain in my chest, which made me initially think it was due to my HBP, but my pressure was normal and I have taken my pills during this time.
45 2021-07-07 swelling face Swelling of cheeks, tongue, and lips (not severe-patient was able to still breath and talk properly)... Read more
Swelling of cheeks, tongue, and lips (not severe-patient was able to still breath and talk properly). Stated that the areas just felt tight/tingly/itchy
45 2021-07-08 sepsis, pancreatitis Right after 2nd shot for 4 hours after I had tachycardia up and down. Then almost 2 weeks later I go... Read more
Right after 2nd shot for 4 hours after I had tachycardia up and down. Then almost 2 weeks later I got an uti, that within 3 days turned into a severe kidney infection into sepsis. My liver enzymes were in the 500?s. My right kidney was swollen and I spent 4 days in the hospital and it took a month to return to normal. Then 3 weeks later I get diagnosed with pancreatitis on June 21. Symptoms subsided now they are back again. Fever, abdominal tenderness, flank pain, aches, and diarrhea and nausea. Took covid test always comes back negative.
45 2021-07-10 peripheral swelling bad headache; left arm soreness; body aches; unable to walk up/down stairs; lower extremity pain/the... Read more
bad headache; left arm soreness; body aches; unable to walk up/down stairs; lower extremity pain/the bottom of feet hurt so bad that it was difficult for me to walk up and down my stairs; bad chills multiple times a day for 6 weeks, and remaining intermittent chills; being in bed for 2 straight days sleeping for 17 hours 2 to 3 days after her first dose; , tinea versicolor rash on her back/arm and after she got the vaccine, the rash "exploded" when she brushed against a weed in the garden causing her arm to blow up; I couldn't lift my arm my arm couldn't touch; joint pain; I experience severe fatigue so much, so I was in bed for two days; when she brushed against a weed in the garden causing her arm to blow up; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via medical information team. A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EN6206; Expiration Date: not reported), via intramuscular route, administered in left arm on 13Mar2021 at 16:30 (at the age of 45-year-old) as dose 1, single for covid-19 immunisation. The patient medical history was none. The patient was not taking any concomitant medication. Patient had been seeing a psychiatrist for the past five years and this psychiatrist provides her prescriptions for all of her medications including her ADD medications. Patient stated she never goes to the doctor and she does not see a primary care physician. Patient stated she was in the "really small group of rare side effects for every ADD medication she has ever been on". Prior vaccination before four weeks the patient did not receive any medication. On an unspecified date in Mar2021, the patient experienced multiple adverse reactions including bad headache, left arm soreness that prevented her from touching or raising it, body aches that lasted five weeks, 3 days unable to walk up/down stairs due to lower extremity pain, the bottom of feet hurt so bad that it was difficult for me to walk up and down my stairs, lower extremity pain, bad chills multiple times a day for 6 weeks, and remaining intermittent chills a couple times a week for the past 7 or 8 weeks, being in bed for 2 straight days sleeping for 17 hours 2 to 3 days after her first dose, tinea versicolor rash on her back/arm and after she got the vaccine, the rash "exploded" when she brushed against a weed in the garden causing her arm to blow up, could not lift my arm my arm could not touch, significant joint pain, severe fatigue so much, so she was in bed for two days. The patient stated that she got vaccinated, Saturday 13Mar2021 and her symptom started, she had very typical symptoms severe arm pain. She could not lift her arm and her arm could not touch. She had a headache and then her symptoms really started, Monday, Tuesday, Wednesday and Thursday. 15 ,16, 17 ,18." She had multiple adverse reactions including a bad headache, left arm soreness that prevented her from touching or raising it, body aches that lasted five weeks (including 3 days where she was unable to walk up/downstairs due to lower extremity pain), bad chills multiple times a day for 6 weeks, and remaining intermittent chills a couple times a week for the past 7 or 8 weeks, . Patient also reported being in bed for 2 straight days sleeping for 17 hours 2 to 3 days after her first dose. Patient stated that she had a Tinea Versicolor rash on her back/arm, and after she got the vaccine, the rash "exploded" when she brushed against a weed in the garden causing her arm to "blow up." She experienced severe fatigue so much, so that she was in bed for two days. She had chills, really bad chills and It had been about 14 weeks since she got her vaccination and since after the first six or seven week, she still got chills a couple times a week. It was reported that the second dose was scheduled for 06Apr2021, but she cancelled that and had only first shot because of all of her concerns. Patient stated that done my reaction to my first dose are significant and these were more reactions that people were experience with the booster, their second dose so my doctor concern was that, should not have experiencing such strong side effects to the first vaccine from the first dose and to concerning how I am I react to this second dose and we will wondering if Pfizer, Because My doctor, I am very sensitive to medication like extremely sensitive to medication and because of my size am worried little my doctor doesn't think, I have any business receiving it full dose as the second vaccination we are wondering, If Pfizer can Order a smaller dose of it of the second one. Patient stated she has spoken to her psychiatrist about this and he recommended she call Pfizer to report her symptoms and ask about the second dose. Patient questioned if there was an antibody test she could get to determine if she is adequately protected against Covid-19 from her first dose. The patient asked if her side effects would be considered severe and if she could get smaller dose of the Pfizer BioNTech Covid-19 vaccine as her second dose. Patient did not receive any treatment for the events. The outcome of the events was unknown.
45 2021-07-11 lymph node swelling I had swollen lymph nodes in my arm pits and breast, resulting in diagnostic mammogram and ultrasoun... Read more
I had swollen lymph nodes in my arm pits and breast, resulting in diagnostic mammogram and ultrasound followed by a second mammogram one month later. This was before this known side effect was largely publicized.
45 2021-07-11 peripheral swelling Patient had left lower extremity pain x 4 days with left lower extremity swelling x 2 days. Patient ... Read more
Patient had left lower extremity pain x 4 days with left lower extremity swelling x 2 days. Patient diagnosed with an extensive deep vein thrombosis in left lower extremity.
45 2021-07-12 peripheral swelling "dehydration" "back and shoulder aches" "feet swelled" "legs wouldn't move, felt tight and dehydrat... Read more
"dehydration" "back and shoulder aches" "feet swelled" "legs wouldn't move, felt tight and dehydrated" "legs felt locked up"
45 2021-07-15 lymph node swelling Swollen lymph node in my left armpit
45 2021-07-17 lymph node pain, lymph node swelling COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left ... Read more
COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 26March2021 at 14:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included birth control (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN): all from unknown date for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and sulfa meds on an unknown date for unspecified indication and experienced a sulfonamide allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27March2021 at 03:00, the patient experienced muscle aches and chills as expected and her lymph node in her armpit of the arm injected to harden and the area to swell to a visible level. It was still very tender and swollen. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event muscle aches, chills, swollen lymph node and lymph node tenderness was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
45 2021-07-17 lymph node pain Arm ache; aches; fever; lymph ache (in armpit); This is a spontaneous report from a non-contactable ... Read more
Arm ache; aches; fever; lymph ache (in armpit); This is a spontaneous report from a non-contactable consumer, the patient. A 45-years- old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733) via an unspecified route of administration in the right arm on 26Mar2021 at 09:00 AM (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL) for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6199), via an unspecified route of administration in the left arm on 05Mar2021 at 01:15 PM (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021, the patient experienced arm ache, lymph ache in armpit, fever and aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of arm ache, lymph ache in armpit, fever and aches was recovered on unknown date. No follow-up attempts are needed. No further information is expected.
45 2021-07-17 lymph node swelling, lymph node pain Swollen lymph node in the underarm area of the injection arm.; painfull lymph nodes in the underarm ... Read more
Swollen lymph node in the underarm area of the injection arm.; painfull lymph nodes in the underarm area of the injection arm.; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via unspecified route of administration in the right arm on 27Mar2021 at 16:15 as a single dose for COVID-19 immunisation. Medical history included lupus, blood clotting disorder, rheumatoid arthritis (RA). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via unspecified route of administration in the right arm on 03Mar2021 at 16:30 as a single dose for COVID-19 immunisation. The patient previously received adalimumab (HUMIRA) on unknown date and for unspecified indication and the patient experienced drug allergy. Concomitant medication included etanercept (ENBREL) for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 08:00, the patient experienced swollen and painful lymph node in the underarm area of the injection arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive ant treatment for events. The clinical outcome of the events swollen and painful lymph node was not resolved at this time of report. No follow-up attempts are needed. No further information is expected.
45 2021-07-17 lymph node swelling Swollen nodule located on left side of soft tissue of neck; This is a spontaneous report from a cont... Read more
Swollen nodule located on left side of soft tissue of neck; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number ER 8727), via an unspecified route of administration in the left arm on 25Mar2021, at 10:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included obesity. The patient did not have any allergies to medications, food or other products. The patient had received unspecified medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EN 6205), via an unspecified route of administration in the left arm on 04Mar2021, at 10:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 29Mar2021 the patient underwent nasal swab test for COVID-19 virus test and the test result report was pending. On 27Mar2021 at 22:00, the patient experienced swollen nodule located on left side of soft tissue of neck. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of swollen nodule located on left side of soft tissue of neck was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
45 2021-07-20 swelling significant swelling and pain in left under arm; Pain in left under arm and moving into left pec; Ti... Read more
significant swelling and pain in left under arm; Pain in left under arm and moving into left pec; Tightness in surrounding muscles andinto bilateral upper traps; Pain in left under arm and moving into left pec; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 30Mar2021 at 15:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included multivitamin (MANUFACTUER UNKNOWN), angelica polymorpha, atractylodes macrocephala, bupleurum falcatum, glycyrrhiza uralensis, mentha canadensis, paeonia lactiflora, poria cocos, zingiber officinale (XIAO YAO SAN) (herbal) and vitamin d nos (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 15:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 31Mar2021 at 04:00, the patient experienced significant swelling and pain in left under arm, moving into left pec and tightness in surrounding muscles and into bilateral upper traps. The events resulted in the doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events significant swelling and pain in left under arm, moving into left pec and tightness in surrounding muscles and into bilateral upper traps. The clinical outcomes of the events swelling, armpit pain, muscle tightness and muscle pain were resolving at the time of the report. No follow-up attempts are needed. No further information is expected.
45 2021-07-21 lymph node swelling, oral herpes Mouth was drooping; Swollen lymph nodes; Liver enzymes were abnormally elevated; Cold sores; Arms we... Read more
Mouth was drooping; Swollen lymph nodes; Liver enzymes were abnormally elevated; Cold sores; Arms were numbing when sleeping; Eyes were burning; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0196) via an unspecified route of administration in left arm on 27Jun2021 at 13:00 (at the age of 45-years-old) as first dose, single for COVID-19 immunization. Medical history included anemic and iron deficiency. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Jun2021, the patient experienced eyes were burning at night while sleeping they started burning a few days after the vaccine. On 05Jul2021, the patient experienced liver enzymes were abnormally elevated and cold sores. On 07Jul2021, the patient experienced swollen lymph nodes. On 08Jul2021, the patient experienced mouth was drooping. On an unspecified date in Jul2021, the patient experienced arms were numbing when she was sleeping started three or four days ago and last night did not feel the numbing in her arms, she thought it has recovered completely. Patient reported that when she saw her face she thought she had a stroke and rushed to ER. She confirmed that she was not admitted. Therapeutic measures were taken as a result of mouth was drooping (bell's palsy), treatment was received as steroid and an antiviral medication. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date in 2021, computerized tomogram: do not have stroke on an unspecified date 2021, hepatic enzyme: liver enzymes were still elevated on 05Jul2021, magnetic resonance imaging: do not have stroke on an unspecified date in 2021. Patient was told at ER that she did not have a stoke and probably had Bells Palsy. The outcome of events of eyes were burning was recovered on an unspecified date in 2021, arms were numbing when sleeping was recovered on an unspecified date in Jul2021 and the outcome of events mouth was drooping, cold sores was recovering while the outcome of events swollen lymph nodes, liver enzymes were abnormally elevated was not recovered.
45 2021-07-22 lymph node swelling Swollen lymph nodes; Chills; Aches; This is a spontaneous report from a contactable consumer, the pa... Read more
Swollen lymph nodes; Chills; Aches; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 02Apr2021 at 09:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. The patient had no known allergies to medications, food or other products. Concomitant medications included curcuma longa (TURMERIC), fish oil (MANUFACTURER UNKNOWN) and loratadine (CLARITIN), all from unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 12Mar2021 at 10:00 (at the age 45-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021, the patient experienced swollen lymph nodes, aches and chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of swollen lymph nodes, ache, and chills was not resolved at the time of the report. No follow-up attempts are needed; information about lot/ batch number cannot be obtained.
45 2021-07-22 lymph node swelling Painful swelling of lymph nodes near right collarbone.; This is a spontaneous report from a contacta... Read more
Painful swelling of lymph nodes near right collarbone.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the arm right on 26Mar2021, at 12:00(at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history included anxiety and depression. Concomitant medications included lithium (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication, melatonin (MANUFACTURER UNKNOWN) from from an unknown date for unknown indication, escitalopram oxalate (LEXAPRO) from an unknown date for unknown indication, lamotrigine (MANUFACTURER UNKNOWN) from an unknown date for unknown indication and clonazepam (KLONOPIN) from from an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 1Apr2021 at 20:00, the patient experienced painful swelling of lymph nodes near right collarbone. The patient did not receive any treatment for the event. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event painful swelling of lymph nodes near right collarbone was recovering. No follow-up attempts are needed. No further information is expected.
45 2021-07-27 peripheral swelling chills; fever; my left arm is so swollen; severe pain; huge lump on the injection site and still swo... Read more
chills; fever; my left arm is so swollen; severe pain; huge lump on the injection site and still swollen; huge lump on the injection site and still swollen; This is a spontaneous report from a contactable Other Health Care Professional (HCP) (Patient). A 45-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982, Expiration date was not reported), via an unspecified route of administration, in arm left, on 06Feb2021 at 13:00 (at the age of 45-year-old), as a single dose for covid-19 immunization. The patient medical history included high blood pressure. Concomitant medications included zinc and boswellia serrata resin, colecalciferol, collagen (OSTEO BI-FLEX EASE). Historical vaccine included the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982, Expiration date was not reported), via an unspecified route of administration, in left arm, on 16Jan2021 at 12:00 (at the age of 45-year-old), as a single dose for covid-19 immunization. The patient had no known allergies. The patient had no covid prior vaccination. The patient had not tested post vaccination. Facility type vaccine was reported as Nursing Home/Senior Living Facility. There was no other vaccine received in four weeks. On 07Feb2021 at 15:00, on the second dose the patient had chills, fever and my left arm is so swollen with severe pain. She stated that now its Wednesday and I received the shot on Saturday. There is a huge lump on the injection site and still swollen with a huge bump. There was no treatment received for adverse events. Outcome of the events huge lump on the injection site and still swollen was reported as not recovered and chills, fever, swollen arm, pain was reported as recovering. Follow-up attempts completed. No further information expected.
45 2021-07-27 swelling PATIENT SAYS SHE EXPIERENCED NAUSEA AND VOMITING, EXTREME FATIGUE, CHEST PAIN, JOINT PAIN AND SWELLI... Read more
PATIENT SAYS SHE EXPIERENCED NAUSEA AND VOMITING, EXTREME FATIGUE, CHEST PAIN, JOINT PAIN AND SWELLING SO MUCH THAT SHE COULD BARELY WALK AND A BIG KNOT/SWELLING AT THE INJECTION SITE. SYMPTOMS STARTED THE EVENING AFTER RECEIVING THE VACCINE, BUT BECAME SO SEVERE AFTER 2 DAYS SHE WENT TO THE EMERGENCY ROOM. SHE SAID THEY GAVE HER IV FLUID BECAUSE SHE WAS SO DEHYDRATED AND MEDICATION FOR NAUSEA. THE DOCTOR DID NOTICE THE INJECTION SITE ALSO. SHE IS DOING BETTER NOW, BUT STILL HAS SOME LINGERING FATIGUE AND JOINT PAIN.
45 2021-07-28 swelling face migralepsy migraine; Head ache; nausea; fatigue; blisters in mouth; swelling of joints and face; swe... Read more
migralepsy migraine; Head ache; nausea; fatigue; blisters in mouth; swelling of joints and face; swelling of joints and face; severely ill; This is a spontaneous report from a contactable consumer. A 45-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 02Apr2021 at 10:30 AM, at patient age of 45-year-old, as single dose (Lot number Erb8733) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included migralepsy migraine and arthritis. Known allergies included cefalexin monohydrate (KEFLZ), amoxicillin, penicillin, alprazolam (XANAX), ondansetron (ZOFRAN), cantaloupe. The patient's concomitant medications included naproxen sodium (ALEVE), cucurbita pepo oil (PUMPKIN SEED OIL). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 12Mar2021 at 10:30 AM, at patient age of 45-year-old, as single dose (Lot number En6206) for COVID-19 immunization and no reaction on previous exposure to vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the second dose of bnt162b2 on 02Apr2021. The patient stated that "I think they tried to poison me". On 02Apr2021 at 16:00 PM, the patient experienced headache, set off migralepsy migraine, nausea, fatigue, blisters in mouth, swelling of joints and face, severely ill and only out of bed short periods at a time for two days now. The patient did not receive treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. Follow-Up (28Jul2021): Follow-up attempts are completed. No further information is expected.
46 2021-01-02 swelling face Started to lose voice and clearing throat- took benedryl as suggested , stayed an extra hour for obs... Read more
Started to lose voice and clearing throat- took benedryl as suggested , stayed an extra hour for observation, left on my own. Noticed face was swollen and red after showering- took photo. Cough and clearing throat like when I eat something I?m allergic to. Took another benedryl four hours later as well as Tylenol for headache. Ate dinner went back to sleep notice arm hurts a bit. Next morning 9 am face no longer swollen but arm hurting to the slightest touch. 4:30 pm still resting arm very painful . Headache and facial swelling under control. At no time did I have trouble breathing, slight itching
46 2021-01-04 peripheral swelling, anaphylactic reaction Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her ... Read more
Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her own albuterol inhaler without relief. Transported to ED. PE: red hands with swelling, throat and lip swelling with difficulty swallowing. Later developed headache and dizziness then tachypnea and stridor. Meds given - See section 5 PLUS epinephrine IM and infusion @ 0.05 mcg/kg/min, Alb and ipratropium negs, racemic epi nebs. Admitted to the hospital on 12/22 and still hospitalized at the time of this report on 12/23. She remains on an epinephrine drip and was given methylprednisolone 125 mg IV x 2. No previous history of anaphylaxis. History of Reye's syndrome as a child when given aspirin.
46 2021-01-04 swelling face At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen an... Read more
At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen and tried to go to sleep. I was unable to sleep on my left side as normal. Around 12:30am I woke up cold, shivering violently, with a fever of 103.°3. My feet were also burning. I woke up around 2:30am. Fever was down to about 102.4°, feet were still burning and my face and eyes were swollen. I took more ibuprofen and put used cold compress on my eyes. Around 4:30am I woke up with abdominal pain and pain in my hips. Fever was lower, eyes were better but face still swollen and feet still burning. I called off work at that time. By about 8am fever broke and have just had an intense headache.
46 2021-01-04 swelling, swelling face, anaphylactic reaction Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of... Read more
Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of airway and dizziness)
46 2021-01-05 lymph node swelling 3 days after injection (Thursday 12/24/20)noticed pain and pressure from jaw to ears on left side of... Read more
3 days after injection (Thursday 12/24/20)noticed pain and pressure from jaw to ears on left side of face. Saturday morning (12/26/20) noticed left lymph node was swollen. Sought medical care-DX anterior cervical lymphadenopathy.
46 2021-01-05 swelling UrticariaPruritus Narrative: 0933 PT STATES SHE FELT "ITCHY"/ VS- 133/89; P-93; SAT 98%; TEMP 98.3. ... Read more
UrticariaPruritus Narrative: 0933 PT STATES SHE FELT "ITCHY"/ VS- 133/89; P-93; SAT 98%; TEMP 98.3. 0957 PT STATES NOW ITCHING TO PALATE; FEELS "SWOLLEN"; NO NOTED OBSTRUCTION TO AIRWAY NOTED; EMS CALLED; 1015 PT DECLINED TRANSPORT TO ER VIA EMS; REMAINS STABLE; SAT 98%; DENIES DIFFICULTY BREATHING. 1035- BENADRYL 25MG PO ONCE ORDERED BY DR, AND GIVEN BY RN. VSS; P-74; R-16; SAT-99%; BP-133/79; TEMP-98.6;PT ABULATED TO OFFICE; HUSBAND TO DRIVE PT HOME LATER TODAY.
46 2021-01-06 lymph node pain fever 100.3, lymph pain, body aches
46 2021-01-06 lymph node swelling 12 hours after vaccine I felt chills, headache, fever, dizziness, weakness, pain and swelling to inj... Read more
12 hours after vaccine I felt chills, headache, fever, dizziness, weakness, pain and swelling to injection site, body aches, lymph node swelling. 36 hours after, still have piercing headache, fever, body aches, lymph node swelling, weakness, on and off chills and dizziness.
46 2021-01-06 lymph node swelling Day 1: strong ache in all joints, mild nausea, headache Day 2: swollen lymph nodes in left arm & nec... Read more
Day 1: strong ache in all joints, mild nausea, headache Day 2: swollen lymph nodes in left arm & neck, severe back ache low temp 99-100.3 Day 3: @ 0300 fever 101.5, chills (rigors 3hrs), very bad headache, neck pain, joints and lymph swelling. Had both regular and Rapid covid test and rapid was negative. Awaiting FLU swab and regular Covid test. Day 4: continued fevers 99-100.9, back and neck pain, milder headache.
46 2021-01-06 lymph node swelling Pfizer vaccine 12/19. Reports intermittent dizziness, brain fog, severe headaches, nausea, shortnes... Read more
Pfizer vaccine 12/19. Reports intermittent dizziness, brain fog, severe headaches, nausea, shortness of breath, left axillary lymphadenopathy, elevated blood pressure which onset on 12/31. COVID-flu negative, normal labs, CT thorax and brain MRI negative. Has been to ED and is returning today due to continued symptoms. Reported symptoms to VSafe
46 2021-01-06 swelling face 01/06/2021 r eyelid swollen, face and upper lip; provider gave epi -- reduced some swelling. L wris... Read more
01/06/2021 r eyelid swollen, face and upper lip; provider gave epi -- reduced some swelling. L wrist swelling today 1/07/2020 sinus tachycardia 140-150.
46 2021-01-06 swelling, swelling face Within 30-45 minutes after injection, became ill with extreme dizziness, facial/neck swelling, skin ... Read more
Within 30-45 minutes after injection, became ill with extreme dizziness, facial/neck swelling, skin pale, diaphoretic, c/o nausea with vomiting x1. Taken to ED. Treated with Benadryl 50mg IV, Zofran 4mg SL, meclizine 25mg PO, and 1 liter of 0.9% Normal Saline IV. Symptoms improved, discharged to home at 6pm.
46 2021-01-07 herpes virus infection had an occurrence on Monday of an outbreak of herpes; The initial case was missing the following min... Read more
had an occurrence on Monday of an outbreak of herpes; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse reporting for herself. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously took valaciclovir hydrochloride (VALTREX). Patient stated "I stopped taking my Valtrex a week before getting the vaccine. I got the vaccine on Friday. I started having symptoms again and started taking it again". Patient also stated "I've been told that effectiveness of flu vaccine might not be as good for people taking this medication". Patient was inquiring about taking Valtrex medication before/during her 2 dose vaccine. She stated that she is a nurse in healthcare and she received an email. She received her first dose of the Covid vaccine on a Friday and had an occurrence on Monday of an outbreak of herpes. She stated she was taking Valtrex to suppress her symptoms for a year and stopped taking her medication a week before receiving the vaccine. She stated that she tested for Covid a week before receiving the vaccine as well due to exposure at work. She stopped the medication and panicked thinking it would have an interaction since reading information regarding flu vaccine. Patient states she could not get up with HCP regarding stopping her Valtrex so she called Pfizer. She spoke to someone at Pfizer that asked her if it would be okay to relay her information to someone else and she said yes. Then she received a weird email from [Company name] that said they were made aware a person that was under your care received the flu vaccine. Patient states she does not administer vaccines, she works at the hospital. Patient states she called the company and they did not have any information. She also called her HCP who told her to contact Pfizer to see what the email is all about. Her HCP told her to restart her medication and there is no interaction with Valtrex. Her HCP informed her that the only time she should stop taking her Valtrex is if she was receiving the shingles vaccine or a live vaccine. The outcome of the event was unknown. Information about lot/batch number has been requested.
46 2021-01-07 lymph node swelling left arm pain and swollen lymph nodes in left arm pit generalized muscle aches, slight headache, sli... Read more
left arm pain and swollen lymph nodes in left arm pit generalized muscle aches, slight headache, slight fatigue started 12 hours after my second Pfizer dose, better with ibuprofen.
46 2021-01-07 lymph node swelling Lymphadenopathy. Lymph nodes under left arm (side of vaccine administration) became swollen and pain... Read more
Lymphadenopathy. Lymph nodes under left arm (side of vaccine administration) became swollen and painful. Lasted for approximately 1 week. No treatment, did not see anyone for it. I did not take any over the counter pain medication either. It gradually went away on its own.
46 2021-01-08 anaphylactic reaction Anaphylaxis throat felt like it was closing 15 minutes after getting vaccine Narrative: Employee ... Read more
Anaphylaxis throat felt like it was closing 15 minutes after getting vaccine Narrative: Employee self administered epi shot (has history of anaphylactic reaction to several nsaids, tessalon pearls). Bendadryl IM was given at observation area. She was sent to the ER where she was given Solumedrol and Pepcid. She's been seeing an allergist for past 3 months; reports she's had 2 previous shots of epinephrine from "something that was sprayed at work"
46 2021-01-08 lymph node swelling Fever, chills, night sweats, swollen glands under arm, swollen injection site, body aches, headache
46 2021-01-08 swelling face, swelling Angioedema Narrative: Employee presented to ER for right sided facial swelling 9 days following PFIZ... Read more
Angioedema Narrative: Employee presented to ER for right sided facial swelling 9 days following PFIZER injection. Employee did not experience any SOB or chest pain. ER provider administered steroid injection for treatment. Employee returned to work on the day of discharge and states she will follow up with private allergist for further disposition.
46 2021-01-10 lymph node swelling, swollen extremities Large indurated swelling on the left deltoid with a circumferential ring of erythema approximately 1... Read more
Large indurated swelling on the left deltoid with a circumferential ring of erythema approximately 1 cm out. Warm to the touch. Extensive swelling and lymphadenopathy of the axilla, lateral breast up into the pectoralis muscle and into the latissimus muscle. And I
46 2021-01-10 lymph node swelling Golf ball size lymph node in left axilla, mild tingling in left arm
46 2021-01-11 lymph node swelling Severe under armpit swelling with severe pain to the left side . Swollen lymph nodes
46 2021-01-11 peripheral swelling 1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-t... Read more
1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-took tylenol and benadryl 1/7/2021, 6:30 AM, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore, called into work 1/7/2021, 10:20 am, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore-took benadryl and tylenol 1/7/2021, 1:15 PM, very fatigue, fever, body aches, upset stomach, right ear throbbing, fever 100.6-employee health notified, was advised to self monitor for 48 hrs and if no improvement to be tested for COVID on 1/9/2021 1/7/2021, 7:27 PM, completely exhausted, on going headaches, chills off and on, body aches, decreased appetite-tylenol taken 1/8/2021, 10:02 AM, headache, body aches, arm swollen and very painful, the pain traveled to the armpit, felt about 60 % better this day, but still fatigue Symptoms remain the same for the day of 1/8/2021 1/9/2021, 9:38 AM, lingering headache, arm and armpit sore; otherwise, feel much better 1/10/2021, 7:27 PM, Felt much better this day, just little fatigue and arm soreness; otherwise not further symptoms.
46 2021-01-12 lymph node pain, lymph node swelling Swollen and painful lymph nodes in jaw and neck. Myalgia in neck. Right side greater than left. Tin... Read more
Swollen and painful lymph nodes in jaw and neck. Myalgia in neck. Right side greater than left. Tingling around area of right ear and hearing changes on right side. Numbness in arms/fingers. Symptoms presented about 6 days after 1st vaccine , worsened. Persisted for about 5 days.
46 2021-01-12 lymph node swelling Right arm is sore the following day. When i got home from work (1/13/21) took a shower and i was fee... Read more
Right arm is sore the following day. When i got home from work (1/13/21) took a shower and i was feeling the area where i got the shot and when i raise my right arm i notice under my armpit is swollen.
46 2021-01-12 lymph node swelling Headache, fatigue, swollen lymph nodes, chills, fever
46 2021-01-12 swelling face SWELLING LT SIDE OF THE FACE; Narrative:
46 2021-01-13 fluid retention following initial vaccine 12/28, got extremely bloated with joint tightness, fluid overload, inflamm... Read more
following initial vaccine 12/28, got extremely bloated with joint tightness, fluid overload, inflammation, overall discomfort, back pain which radiated to the front of the chest lasting x3 days, took Tylenol. now resolved
46 2021-01-13 peripheral swelling swelling of arm vaccine administered in, redness at injection site, chills
46 2021-01-13 swelling face Symptoms started at 0100 (11hr post vaccination) Severe headache, myalgias, arthralgias, fever 101,... Read more
Symptoms started at 0100 (11hr post vaccination) Severe headache, myalgias, arthralgias, fever 101, fatigue, facial swelling (eyes and nose), blurred vision Symptoms lasted for 48 hours and did not respond to IBU, Toradol, or Tylenol. Headache was the worst that I have ever experienced- missed 2 days of work Symptoms resolved in the morning on 01/14/2020
46 2021-01-13 swelling face Swollen face, wheezing
46 2021-01-14 lymph node swelling achy, chills, swollen lymph node, tired, headache
46 2021-01-14 peripheral swelling Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and ... Read more
Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Tighten in chest; Weakness; dizziness; Slept for over 24 hours; Nausea; vomiting; This is a spontaneous report from a contactable other Health Professional (HCP) (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), via an unspecified route of administration on 07Jan2021 14:30 at single dose in her left arm for covid-19 immunization. Medical history included dermatitis contact and asthma. The patient had allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) at single dose in her left arm on 17Dec2020 14:30 for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced feft arm went total numb for over 72 hours, red and swollen all the way up to the shoulder, tighten in chest, weakness and dizziness, slept for over 24 hours, nausea and vomiting on 08Jan2021 04:30. The events result in doctor or other healthcare professional office/clinic visit. The patient received prednisone 100 mg to treat these events. The outcome of the events was recovered in Jan2021.
46 2021-01-15 peripheral swelling Rash or hives covering the injection arm, plus a swollen index finger. And soreness at injection si... Read more
Rash or hives covering the injection arm, plus a swollen index finger. And soreness at injection site.
46 2021-01-15 swelling face, swelling 12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog. ... Read more
12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog. 2:30 -5 Skin on face feels like it is burning from the inside out & fatigue. Brainfog. 2:30 thru evening Face and neck puffy, red, hives & fatigue.
46 2021-01-15 swelling face Pfizer-BioNTech COVID-19 Vaccine: Within fifteen minutes of vaccination patient reported chest and f... Read more
Pfizer-BioNTech COVID-19 Vaccine: Within fifteen minutes of vaccination patient reported chest and facial flushing , mild facial swelling, and feeling of heart racing. Initial vital signs: blood pressure 117/58 mmHg, pulse 91 beats per minute, and oxygen saturation 97% on room air. Patient administered oral diphenhydramine 50 mg once and observed for a total of one hour from vaccine administration during which symptoms improved. Vital signs were checked every five minutes and remained within normal ranges during entire observation period. Patient given water and juice and left in stable condition.
46 2021-01-16 swelling, swollen extremities Vaccine was administered Friday and Saturday I had body aches, chills, neck pain, and fever. Sunday ... Read more
Vaccine was administered Friday and Saturday I had body aches, chills, neck pain, and fever. Sunday I woke up with a severely swollen armpit and anterior chest
46 2021-01-17 peripheral swelling SWELLING IN ARM THE SIZE OF A BASEBALL. Redness the size of a quarter that is increasing daily. Now ... Read more
SWELLING IN ARM THE SIZE OF A BASEBALL. Redness the size of a quarter that is increasing daily. Now the size of a baseball and growing. hot panful and tender to touch
46 2021-01-18 lymph node swelling I received the 2nd dose of Covid vaccine at 12:40 pm on Tuesday 1/12/2021, around 6:30 pm I started ... Read more
I received the 2nd dose of Covid vaccine at 12:40 pm on Tuesday 1/12/2021, around 6:30 pm I started with cough and the need to keep clearing my throat. By 9 pm, I felt like my lymph nodes in my neck were swollen, my throat was getting sore, and my head was starting to throb. I took 2 tylenol and went to bed. I woke up at 3 am with a 101.6 temp and body aches. By 8 am on 1/13/2021, I could not lift my own body out of bed or roll over. The fever and body aches continued around the clock for 55 hrs. The headaches are debilitating and continue. I have tried Tylenol, Ibuprofen, Excedrin, and Imitrex and none of these have helped. I missed 3 days of work and 2 weekend days trying to recover and i am still not back to normal. Headaches are still happening everyday. At one point in the middle of this, i felt like I should go to the hospital, but I was too sick to get out of bed and shower and make myself go.
46 2021-01-18 lymph node swelling Lymph node on my right collar bone
46 2021-01-18 peripheral swelling On my second does the same night on 1/13/2021 I started feeling nauseas. The next morning on 1/14/20... Read more
On my second does the same night on 1/13/2021 I started feeling nauseas. The next morning on 1/14/2021 I felt horrible, my stomach was hurting, my left arm was swollen, felt really weak & tired, I had a lot of fatigue & I felt very nauseas. It last 24 hrs.
46 2021-01-18 swelling Patient received vaccine around 1pm and during the 15 minute observation period she became nonrespon... Read more
Patient received vaccine around 1pm and during the 15 minute observation period she became nonresponsive. She did not fall, but slumped in her chair and would not answer questions. Glazed look. Removal of mask showed swollen lips and neck and an epi-pen was administered at 1:14 and 911 called immediately. During the next 5 minutes the patient began to answer questions. EMTs arrived 1:25 and by then the patient was speaking, and did not want to go to the emergency room. EMTs loaded her onto the stretcher and transported her at 1:35.
46 2021-01-18 white blood cell count increased Patient had received second Pfizer vaccination after no reported issues with the first dose. Patien... Read more
Patient had received second Pfizer vaccination after no reported issues with the first dose. Patient was observed post vaccination without incident and released. Patient developed wheezing and attempted to treat with her albuterol inhaler but did not improve. patient presented to the ED approximately 2 hours after vaccination and was admitted for respiratory failure and placed on BiPAP for a brief period of time. patient has known history of Asthma Exacerbation requiring hospitalization and intubations. D/C diagnosis Asthma Exacerbation
46 2021-01-19 lymph node swelling about 10 hours after receiving the vaccine, a lymph node under my arm swelled up. it was the arm tha... Read more
about 10 hours after receiving the vaccine, a lymph node under my arm swelled up. it was the arm that i received the vaccine in. then i became tired and developed a headache, fever and sore throat. that lasted a few days and has since resolved. i was tested for covid after to make sure i did not contract the virus at my place of employment. it was negative.
46 2021-01-19 swelling, lymph node swelling the day following the vaccine this patient had lots of arm pain, swelling of the neck, and a swollen... Read more
the day following the vaccine this patient had lots of arm pain, swelling of the neck, and a swollen lymph node near her collar bone
46 2021-01-20 anaphylactic reaction Systemic: Anaphylaxis-Severe
46 2021-01-20 axillary mass Severe debilitating headache/severe headache; Fever 103 lasting 24 hours, coming down to 100 after t... Read more
Severe debilitating headache/severe headache; Fever 103 lasting 24 hours, coming down to 100 after that; fatigue; Lump in left armpit area; second dose on 08Jan2021/first dose on 22Dec2020; second dose on 08Jan2021/first dose on 22Dec2020; This is a spontaneous report from a contactable Other HCP (patient). A 46-year-old female patient received the second dose of BNT162b2 (Lot number: EL1284), via an unspecified route of administration in left arm on 08Jan2021 09:30 at single dose for covid-19 immunization. Medical history included thyroid condition. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously received the first dose of BNT162b2 (Lot number: EL1284), at the age of 46-year-old, via an unspecified route of administration in left arm at single dose on 22Dec2020 15:30 for covid-19 immunization. The patient experienced severe debilitating headache that she wondered if she should go to ER for. Fever 103 lasting 24 hours, coming down to 100 after that. Unable to get out of bed for 24 hours due to fatigue, fever and severe headache. Lump in left armpit area. The above events were occurred at 20:30 on 08Jan2021. The patient did not receive the treatment for the above events. The patient received the first dose on 22Dec2020, second dose on 08Jan2021. The patient was not pregnant. The patient underwent lab tests and procedures which included body temperature: 103 on 08Jan2021, 100 in Jan2021. The outcome of the events headache, fever, fatigue, Axillary lump was recovering.
46 2021-01-21 lymph node swelling 8 1/2 hrs. after receiving 2nd dose, right arm became very painful, right axillary lymph nodes enlar... Read more
8 1/2 hrs. after receiving 2nd dose, right arm became very painful, right axillary lymph nodes enlarged, and right breast pain and swelling started. Symptoms impeded function of arm. Seen by a provider on 1/19/2021
46 2021-01-21 lymph node swelling I received the second dose of the vaccine on Tuesday morning, and took 800 mg ibuprofen afterward to... Read more
I received the second dose of the vaccine on Tuesday morning, and took 800 mg ibuprofen afterward to ward off arm soreness. I had quite a bit of pain at the injection site with this vaccine, more severe than the initial dose. I felt the same mild fatigue and headache as with the first dose, but yesterday (Thursday (01/20/21) afternoon, around 3-4pm), I noticed soreness in my right axillary area, and found lymphadenopathy with palpation. I took additional ibuprofen and tylenol, and the pain has lessened somewhat today (Friday 01/22/21, noon)
46 2021-01-21 swelling face Nausea and vomiting within 45 minutes of vaccine. Left side facial numbness, allergic swelling of f... Read more
Nausea and vomiting within 45 minutes of vaccine. Left side facial numbness, allergic swelling of face within 1 hour of vaccine, lasting 24 hours with Benadryl & Pepcid given as treatment. Numbness of face occurring 1 week post vaccine. Benadryl given as treatment.
46 2021-01-22 peripheral swelling localized reaction to left arm with erythema swelling and warmth
46 2021-01-23 lymph node swelling Muscle aches and swollen lymph nodes
46 2021-01-24 swelling fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive he... Read more
fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive headache; eye pressure/Pressure in eyes; Body aches; Muscle spasms/Cramping; tired/tiredness/fatigue/feeling rundown; hot and cold chills; tremors; coughing; chest pain; swelling; unable to work; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via intramuscular on 06Jan2021 09:45 at single dose on left arm for COVID-19 immunization. The patient's medical history included asthma, arthritis and COVID-19. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EH9899) on 16Dec2020 09:45 at single dose for COVID-19 immunization. Facility type vaccine was workplace clinic. Patient was not pregnant. No other vaccine received in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was a PCT Patient Care Technician. Patient had not been feeling well/sick on 06Jan2021 since receiving her second vaccine dose. Patient said she was unable to work, and was still feeling sick. Patient experienced massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/tiredness/fatigue/feeling rundown, hot and cold/chills on 06Jan2021 11:00. These adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient stated she had reactions coughing, chest pain, swelling, tremors in Jan2021. Patient said she couldn't bend without having a muscle spam. Patient clarified if she tries to wipe herself after she goes to the bathroom, she has muscle cramping. Patient clarified if she tries to turnover in bed, she has charley horses everywhere. Patient reported walking hurts from having so many charley horses. Patient said the headache seemed like it was progressing. Patient was feeling rundown and tired. Patient reported she had hot and cold chills over the weekend. Something didn't feel right on 11Jan2021, so she took her temperature and she had a 100.1 degree fever. Patient clarified she did not check her temperature prior to 11Jan2021. Patient reported she has been taking ibuprofen 800mg to maintain herself as treatment. She said she took some of the ibuprofen 800mg over the weekend, and then decided to take her temperature on 11Jan2021, and that was when she discovered she had a fever. Reported the ibuprofen 800mg was a prescription from her doctor and was dispensed in an amber pharmacy bottle. Patient stated she had lab work for, because of COVID her lungs has been messed up but before she had the shot she was doing pretty good. So, she would be getting tested periodically for her lungs and all that because she had COVID at one time. Patient stated the doctors gave her prednisone and antibiotics as treatment. For antibiotics name, Patient stated amoxycillin she believed it was and the doctors gave her another pill start with a M for swelling. Patient stated her doctor did said it had nothing to do with concomitant medication and other medication conditions. The doctor said it had to do with having the shot. Treatment for adverse events (headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms, cramping, tired, fatigue, temperature over 100.1, hot and cold/chills) included penicillin, amoxicillin, prednisone. Outcome of massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/fatigue, temperature over 100.1, hot and cold/chills were not recovered, outcome of other events was unknown.
46 2021-01-25 lymph node swelling Extreme body achees; Severe headache; lymphadenopathy in the armpit.; This is a spontaneous report f... Read more
Extreme body achees; Severe headache; lymphadenopathy in the armpit.; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient (no pregnancy) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly at site of left arm at 10:30 on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 on an unspecified date. The patient experienced extreme body achees, severe headache, lymphadenopathy in the armpit, all at 21:30 on 11Jan2021. Adverse reactions did not result any serious consequences. Facility type vaccine was hospital. No need treatment for adverse event. No covid prior vaccination. No covid tested post vaccination. No known allergies. Other medical history was none. The outcome of events was recovering. Information on the lot/batch number has been requested.
46 2021-01-25 lymph node swelling day of felt "fuzzy" tired chills/rigors and fever 103, body/aches. 1/7 temp 99 still taking APAP q 3... Read more
day of felt "fuzzy" tired chills/rigors and fever 103, body/aches. 1/7 temp 99 still taking APAP q 3 hrs. nausea. rt axilla swollen and severe pain. 18/ bilateral hand numbness and tingling up to elbow. temp normal, nausea better. no axilla or neck swelling. reports tremors (that aren't visible) when tries to write "feels not right". 1/11 all sxs resolved. ok to work.
46 2021-01-26 lymph node swelling, lymph node pain the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; ... Read more
the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; I felt a "hot flash" over my face; anxiety; the left side of my face started to tingle and went numb; the left side of my face started to tingle and went numb; Lymph nodes in my neck were swollen and painful; Lymph nodes in my neck were swollen and painful; This is a spontaneous report from a contactable Other healthcare professional (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included allergies: Penicillin, irritable bowel syndrome (IBS) and endometriosis. The patient's concomitant medications were not reported. The patient previously took dilaudid and experienced drug allergy. A minute after vaccination on 12Jan2021, the patient felt a "hot flash" over her face, thought it was anxiety and ignored it. 25-30min after vaccination the left side of her face started to tingle and went numb, lasted a few hours and went away. That night the patient's lymph nodes in her neck were swollen and painful. The following day after vaccination on 13Jan2021, the tingling/numbness came back in her face in waves, but moved to her lips and the tip of tongue. Day 3 after vaccination on 14Jan2021, the patient still feel some slight numbness in waves still only on one side of her face and the tip of tongue, but not as intense or frequent. Not sure if this could be an allergic reaction. Injection site was left arm and it was the left side of her face effected. The patient underwent lab tests and procedures which included COVID test Nasal Swab: negative on 14Jan2021. The outcome of events was recovering. Information on Lot/Batch number has been requested.
46 2021-01-26 swelling face right side under her eye was swollen; right side of face was swollen; This is a spontaneous report f... Read more
right side under her eye was swollen; right side of face was swollen; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on the right arm on 12Jan2021 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no concomitant medications. The patient reported she had the first shot on yesterday (12Jan2021); it was given by a nurse at the hospital where she works. Last night, she noticed on the same side that she got shot, her right side under her eye was swollen and the right side of her face was swollen too. She wanted to know what to do and wanted to know if they were side effects. No therapeutics measures were done in response to the events. At the time of last observation, events' outcome was not recovered. Information about Lot/Batch number is requested.
46 2021-01-28 herpes virus infection Reactivating of herpesvirus; This is a spontaneous report from a contactable pharmacist (patient). T... Read more
Reactivating of herpesvirus; This is a spontaneous report from a contactable pharmacist (patient). This pharmacist reported same events for 2 patients. This is the first of 2 reports. A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249, expiration date unspecified), via an unspecified route of administration on 13Jan2021 17:30 at single dose (left arm) for COVID-19 immunization. The patient had no medical history. The patient was not pregnant and had no known allergies. Concomitant medications included calcium and colecalciferol (VIT D3). On 15Jan2021 05:30, the patient experienced reactivating of herpesvirus. Her colleague had exact reaction as well. The patient had no treatment for the event. The patient had no other vaccine in 4 weeks, no Covid prior vaccination and was not Covid tested post vaccination. Outcome of event was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046529 same report/drug/event, different patient
46 2021-01-29 lymph node pain Patient claims axillary and supraclavicular pain, after 48h of 2nd dose vaccination with Pfizer vac... Read more
Patient claims axillary and supraclavicular pain, after 48h of 2nd dose vaccination with Pfizer vaccine. That has recovered in 75% since onset of symptoms. Pt claims tenderness in the right neck area, with a non visible but palpable lump the size of a quarter. Patient took a dose of tylenol 1g which subdued most of the symptoms, and reports today 1/30/2021 only local tenderness, with no other side effects to report. Pt also claims feeling of chills, and flu like symptoms 24 hours after the vaccination which subdued with a dose of Tylenol 1g.
46 2021-01-30 lymph node swelling, lymph node pain Lymph nodes under left arm pit very swollen and tender for 5 days now.
46 2021-01-31 lymph node pain, lymph node swelling Tenderness and induration without erythema at injection site that wrapped around outer arm, under ax... Read more
Tenderness and induration without erythema at injection site that wrapped around outer arm, under axilla and produced tender axillary lymphadenopathy . This occurred within 24 hours of vaccination and is still present 84 hrs after vaccination.
46 2021-01-31 lymph node swelling mildly swollen upper and lower lips, 24 hour onset after vaccine. Also having mild left axillary nod... Read more
mildly swollen upper and lower lips, 24 hour onset after vaccine. Also having mild left axillary node enlargement and mild localized redness at the left delt injection site. Pt received lip fillers slightly over one year ago. She does not remember which brand of name of filler.
46 2021-01-31 lymph node swelling severe headache; severe neck pain; severe arm pain; fever at 103 degrees F; Swollen lymph node; blee... Read more
severe headache; severe neck pain; severe arm pain; fever at 103 degrees F; Swollen lymph node; bleeding gums; small hematomas on legs; extremely hot diarrheas; horrible burning sensation; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EJ1686, expiration date was unknown), via an unspecified route of administration on the left arm on 08Jan2021 at 14:15 at a single dose for COVID-19 immunization administered at the hospital. She received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EK5730, expiration date was unknown) via an unspecified route of administration on the left arm on 18Dec2020. Relevant medical history included known allergies to shellfish. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. On 09Jan2021 at 12:00 AM, the patient experienced severe headache, severe neck pain, severe arm pain, fever at 103 degrees Fahrenheit (F), swollen lymph node, bleeding gums, small hematomas on legs, and extremely hot diarrheas that she had this horrible burning sensation. The patient did not receive any treatment for the adverse events (AE). The patient underwent further lab tests and procedures, which included COVID test via nasal swab post vaccination on 13Jan2021, which resulted negative. The patient was recovering from all the events.
46 2021-01-31 swollen extremities Patient called to report that after receiving her vaccine on Friday: during the middle of the night ... Read more
Patient called to report that after receiving her vaccine on Friday: during the middle of the night she starting feeling chills and had a temp of 101. She took some ibuprofen and her fever broke around 9030 or 1000 on Saturday because she became very diaphoretic. She reports that she slept approx 19 hours on Sat and she had chills and sweats off on during this time period. She just felt weak and tired. On Sunday she felt better, just tired. Today, Monday 2/1 she did not come to work due to being tired and feels dehydrated due to the fever and being weak and sweating spells she had. She also states that her Right arm pit is swollen
46 2021-02-02 peripheral swelling Extreme swelling of Axillary area of right arm. Ibuprofen, Pepcid and Loratidine - Swelling went fr... Read more
Extreme swelling of Axillary area of right arm. Ibuprofen, Pepcid and Loratidine - Swelling went from Softball size to golfball size with first 2 days of medication therapy. Swelling continues to reduce with additional doses.
46 2021-02-02 swelling Cellulitis, redness, swelling, hard lump, heat, tired, headache, pain
46 2021-02-03 peripheral swelling really swollen and sore underneath her arm in her armpit; really swollen and sore underneath her arm... Read more
really swollen and sore underneath her arm in her armpit; really swollen and sore underneath her arm in her armpit/Incredibly sore arm; Fever and chills; Red at injection site; Very tired; Bad headache; This is a spontaneous report from a contactable other health professional reported for herself. A 46-year-old female patient received the first dose of BNT162 (PFIZER-BIONTECH COVID-19 VACCINE, brand: Pfizer, lot number: EL9262,) via unspecified route of administration at age of 46 years old on 21Jan2021 10:15 AM at single dose and vaccine location at left arm, for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included: prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications reported as there had other medications the patient received within 2 weeks of vaccination. The patient past drugs included: allergies to prochlorperazine (COMPAZINE) and amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported really swollen and sore underneath her arm in her armpit. Patient presented fever and chills. Red at injection site. Incredibly sore arm. Patient was very tired and bad headache, the adverse events reported started on 21Jan2021. It was reported the non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. There was no treatment received for the adverse event. Outcome of events were not recovered.
46 2021-02-04 lymph node inflammation reactive lymphadenitis; Naproxen 500mg twice daily for 5 days
46 2021-02-04 swelling left axillary swelling; This is a spontaneous report from a contactable other HCP (patient). A 46-ye... Read more
left axillary swelling; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL9261), intramuscular at Arm Left on 18Jan2021 11:15 at the 46 years old at single dose for COVID-19 immunization. The medical history was none. The concomitant medication was ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc(CENTRUM MULTIGUMMIES). The Historical Vaccine was fist dose BNT162B2 for COVID-19 immunization. The patient previously took Iodine and experienced allergy. There was no other vaccine in four weeks. The patient experienced left axillary swelling on 19Jan2021 22:00. There was no treatment received for the event. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of the event was not recovered.
46 2021-02-06 axillary mass Soreness and a large "nodule" to right axillary
46 2021-02-06 lymph node swelling, swelling face On 2/1/2021 I noticed a cluster of bumps on my left forehead by my hairline. Flesh colored, not itch... Read more
On 2/1/2021 I noticed a cluster of bumps on my left forehead by my hairline. Flesh colored, not itchy. N 2/3/2021 I developed swollen and sensitive lymph nodes in front of left ear. On the evening of 2/4/2021 rash to forehead now red and sensitive and looking more blister like. Left eye blood shot and eyelid and left face swelling. Shooting pains into head on left side. 2/5/2021 made same day appointment with pap. Shingles diagnosed and started on Valacyclovir. Appointment with Ophthalmologist scheduled for 2/8/2021. Went to ER on 2/6/2021 for left eye pain. No change in treatment. Still to follow-up with eye doctor on 2/8/2021. Not able to work due to pain and nature of worK (around pregnant women and babies<1month old).
46 2021-02-07 peripheral swelling pt verbalized tingling in hands and swelling in hands post vaccination.
46 2021-02-07 swelling When driving home , I felt like my right side of my neck was swelling but it wasn?t and then it felt... Read more
When driving home , I felt like my right side of my neck was swelling but it wasn?t and then it felt like my right side of my throat was sweet and then my asthma kicked in , I used my inhaler and I few hours all my symptoms went away.
46 2021-02-08 lymph node swelling Left arm pit lymph swelling and tightness of Internal rotation muscles
46 2021-02-08 lymph node swelling Upper and Lower Lip Swelling, swollen lymph node left axillary. Resolved after 36 hours Used Benadr... Read more
Upper and Lower Lip Swelling, swollen lymph node left axillary. Resolved after 36 hours Used Benadryl 25mg every 8 hours I have had lip filler approximately 14 months prior
46 2021-02-09 lymph node swelling Day 4 I had sinus problems, swollen left lymph node in neck , back pain. Day 2 I itched everywhere, ... Read more
Day 4 I had sinus problems, swollen left lymph node in neck , back pain. Day 2 I itched everywhere, mainly my neck, stomach and back Day 10 Left eye is swollen and pain on eyelid and behind eye lid
46 2021-02-10 lymph node swelling - THINK JUST STRONG IMMUNE RESPONSE: - Headache, dizzy, nauseated, weak, Pelvic pain - Enlarged lymp... Read more
- THINK JUST STRONG IMMUNE RESPONSE: - Headache, dizzy, nauseated, weak, Pelvic pain - Enlarged lymph node on Ipsilalent side of shot - Concentration off BLOOD SUGARS SLIGHT Elevation (129-132 fasting) Decrease in Blood Pressure to 104/76 (usually 120s to 130s/80s
46 2021-02-10 oral herpes Had #2 Pfizer 1/13 8am. At 12 noon noticed tingling and swelling/fullness in upper lip which persist... Read more
Had #2 Pfizer 1/13 8am. At 12 noon noticed tingling and swelling/fullness in upper lip which persists. Slight lightheadeness with exertion, "bad HA," slight ST. During call patient looked in mirror and noted fullness in upper lip with new "cold sore" and lightly flushed forehead w/ flat, non-pruritic, red rash. Denies SOB, wheezing, swelling of tongue or throat. Denies dyphagia, eye swelling. Instructed patient to see provider at clinic now (she is in clinic now) and be evaluated.
46 2021-02-10 swelling Left knee pain, swelling; using leg brace, OTC topicals.
46 2021-02-11 swelling First Dose: On Monday the 21st I started getting a Fever and not feeling good. I found out that day ... Read more
First Dose: On Monday the 21st I started getting a Fever and not feeling good. I found out that day my boss was home with Covid. I did a Saliva test (covid test), while waiting for my test above my collar bone was swollen. I was generally not feeling well. I got my results on the 25th and it was negative. On the 30th I got heart fluttering, feelin racy. It went away. On the 1st, I felt so wiped out and heart was going nuts, and I went to get a EKG that was normal but my BP was high140/high 80. On the 4th I went back to work again and still felt horrible, dizzy and they sent me to the ER and had High BP and two normal EKG', and the hooked me up to a heart monitor for a week. With both shots I had insomnia of the walls. Second Dose: it was much better than 1st dose. The Monday after the 2nd dose I got a really bad headache. I drank some Pedialyte and took a 12 hour nap and felt great after.
46 2021-02-12 swelling I started itching on my limbs approximately 2 hours post injection. This moved to my trunk about 30 ... Read more
I started itching on my limbs approximately 2 hours post injection. This moved to my trunk about 30 min after that. I had several raised red spots at this time. I took OTC Pepcid initially and at bedtime I took 2 benedryls. This relieved all symptoms.
46 2021-02-13 lymph node swelling Pfizer-BioNTech COVID 19 Vaccine EUA LYMPH NODE SWELLING IN RIGHT ARMPIT and Pain.
46 2021-02-16 lymph node swelling Swollen lymph nodes and pain in left underarm (side where shot was given), first noticed approximate... Read more
Swollen lymph nodes and pain in left underarm (side where shot was given), first noticed approximately 10pm on the evening following vaccination. As of this report, lymph nodes are still swollen (12 days post-vaccination, 11 days since appearing) but less painful.
46 2021-02-22 swelling face Heaviness in chest. Swelling on face , eyes and lips
46 2021-02-24 anaphylactic reaction Patient received the 2nd dose of the Covid-19 vaccine at 16:26 today (2/25/21). She reported symptom... Read more
Patient received the 2nd dose of the Covid-19 vaccine at 16:26 today (2/25/21). She reported symptoms of difficulty breathing, tight throat and tight and numb lips at 16:34 today and alerted staff. At 16:35 epinephrine was given for suspected anaphylactic reaction. Vitals at 16:35 before administration of epinephrine were pulse ox 100% and pulse 67. Vitals at 16:37 were pulse ox 100%, pulse 170, and BP 162/102. First response called at 16:35. Patient felt immediate improvement in symptoms with epinephrine administration. First response team took patient to ED for further evaluation at roughly 16:40 by wheelchair.
46 2021-02-24 lymph node swelling swollen and sore lymph nodes in armpits - neck and groin area. not resolved at this time
46 2021-02-26 lymph node swelling, axillary mass Swelling in armpit. There is a large painful lump in my armpit. I noticed the pain the morning after... Read more
Swelling in armpit. There is a large painful lump in my armpit. I noticed the pain the morning after the shot. I checked in the afternoon and saw the lump.
46 2021-02-27 lymph node pain, lymph node swelling Swollen lymph nodes under the arm in the arm pit area. Very painful and swollen Swollen lymph node ... Read more
Swollen lymph nodes under the arm in the arm pit area. Very painful and swollen Swollen lymph node in the neck right above the clavicle. Very painful and swollen Started about around 24-27 hours after the injection Ice bags on both sites at least 2 times per day since symptoms started Took to iuphopens to help with pain/swelling
46 2021-02-28 lymph node swelling headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest an... Read more
headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; This is a spontaneous report from a contactable Consumer (patient). A 46-years-old female patient received bnt162b2 (BNT162B2, Lot number: EM5318) second dose, via an unspecified route of administration on 28Jan2021 at left arm at SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Sulfa from an unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 on 08Jan2021 (vaccine location=Left arm; lot number=EK41, administration time=01:45 PM). Concomitant medication included levothyroxine sodium (SYNTHROID), calcium (CALCIUM), hibiscus tea and green tea. The patient experienced headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back on 28Jan2021 16:00 with outcome of recovering. No treatment received for events. No covid prior vaccination. No covid tested post vaccination.
46 2021-02-28 peripheral swelling arm swelling, tenderness, armpit swelling
46 2021-03-01 lymph node swelling, peripheral swelling sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints h... Read more
sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints hurt; very large lymph node swelling on left (neck/collarbone/under arm).; cough; Spoke to MD regarding feet as it was difficult to walk; vaginal bleeding; headache; fever 101.9; felt like I was in shock; uncontrollable shaking; fast breathing; freezing; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 10Feb2021 at 11:00 AM (at the age of 46-year-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to sulfa drugs. The patient has pins in both feet from prior surgery. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ) on 19Jan2021 at 11:30 AM (at the age of 46-year-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient stated that it was unknown if prior to the vaccination, she had COVID-19. The vaccine was administered in a Nursing Home facility. Concomitant medications were not reported. The patient did not receive other vaccines within four weeks prior to the COVID vaccination. On 11Feb2021 the patient awoke at 1:30 AM with uncontrollable shaking, fast breathing, and she was freezing. She had no temperature at that time, almost felt like she was in shock. She took a shower and got calmed down. She was very nauseous but able to go back to sleep. At 04:30 AM she awoke again, this time with headache and a fever of 101.9. She continued with a fever in the 101.1 to 101.9 range for remainder of the day. The next day, 12Feb2021, she awoke feeling better and no fever but she had welts on her toes and her feet were swollen. Both feet and hand joints hurt and she had very large lymph node swelling on left (neck/collarbone/under arm). She also had developed a cough. She spoke to her MD regarding her feet as it was difficult to walk. They directed her to the Emergency Room (ER). The ER staff said to watch for two days. Later that evening (12Feb2021) she started having some shortness of breath and vaginal bleeding. She has an IUD and has not had a period for four years. She called the ER and they gave same advice. She had no fever that day (13Feb2021) but she woke around 3:30 AM soaked. As of 14Feb2021 she was still short of breath on/off and still has sore feet. The patient did not receive treatment for the events. Lab data included Fever of 101.9 on 11Feb2021 and fever in the 101.1 to 101.9 range also on 11Feb2021. The clinical outcome of shortness of breath was reported as not recovered. The clinical outcome of shock-like symptom, shaking, fast breathing, feeling cold, nauseous, headache, fever, welts, swelling of feet, arthralgia, lymphadenopathy, cough, gait disturbance, vaginal bleeding, hyperhidrosis was reported as recovering. The patient has not been tested for COIVD-19 after the vaccination. Information about lot/batch number has been requested.
46 2021-03-04 lymph node pain, lymph node swelling Swollen and painful lymph nodes around right side colar bone. I have not seen a doctor about this b... Read more
Swollen and painful lymph nodes around right side colar bone. I have not seen a doctor about this but I read that it should go away within 3 weeks.
46 2021-03-04 lymph node swelling Body aches, kidney pain, headache, lethargy beginning 12 hours post shot, beginning 24 hours post sh... Read more
Body aches, kidney pain, headache, lethargy beginning 12 hours post shot, beginning 24 hours post shot painful lymph node pain under left arm and side of breast
46 2021-03-04 swelling Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth /... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Approximately 30 minutes after administration, patient reported some difficulty breathing and extreme lightedheadness. Breathing was shallow. Also reported swollen tongue, which led to slurred speech. Benadryl was immediately given and patient was monitored for an additional hour. At the end, patient reported she felt better and speech improved, but still lightheaded like she \"just had 2 glasses of wine.\"
46 2021-03-07 lymph node swelling Swollen axillary lymph nodes in left arm pit with left breast pain
46 2021-03-08 lymph node swelling, lymph node pain Received dose on 01/12/2021 - left arm - muscle soreness. however on 01/14/2021 developed left axil... Read more
Received dose on 01/12/2021 - left arm - muscle soreness. however on 01/14/2021 developed left axillary lymph node became very swollen and very painful -discomfort. Also became very fatigued and temperature not stable bouncing down to 97.4 - 99.9. these all lasted for about 3 days and then completely went away
46 2021-03-09 lymph node swelling pain/swelling under arm on side of vaccine, later felt swollen lymph area in arm pit. occasional num... Read more
pain/swelling under arm on side of vaccine, later felt swollen lymph area in arm pit. occasional numb sensation down left arm into wrist and fingers.
46 2021-03-09 peripheral swelling Within 10 minutes I got very dizzy and nausea and vomiting which lasted over 12 hours. Also racing h... Read more
Within 10 minutes I got very dizzy and nausea and vomiting which lasted over 12 hours. Also racing heart rate then episodes of chills and sweating. The next day I had a hard time holding my tooth brush, pain and swelling to both hands and severe pain in left foot. When I get up from sitting position to walking it feels like my bones in my left foot will shatter. The pain is very bad even in bed when I?m not moving.
46 2021-03-10 lymph node swelling Swollen lymph nodes right armpit day after injection, fatigue, dizziness was only immediately after ... Read more
Swollen lymph nodes right armpit day after injection, fatigue, dizziness was only immediately after injection but subsided, chills are off and on mild.
46 2021-03-11 lymph node swelling extreme headache, flush face, flu like symptoms and swollen lymph note under right arm
46 2021-03-11 sepsis patient administered vaccine at another facility and presented to this facilities ED on 2/24. Patie... Read more
patient administered vaccine at another facility and presented to this facilities ED on 2/24. Patient with multiple comorbidities: Bipolar disorder, parkinsons, PD, COPD, DM, PVD, GERD, HTN, Dyslipidemia, sleep apnea. H/O CVA, has sacral decubitus and cellulitis of pannus. presents with sepsis likely secondary to cellulitis of pannus. Admitted for care then discharged on 2/26
46 2021-03-12 lymph node swelling, lymph node pain Swelling and tenderness in left arm pit and chest area
46 2021-03-14 lymph node pain, lymph node swelling March 10, 9am, received injection in left arm. Minor headache throughout the day. That afternoon (... Read more
March 10, 9am, received injection in left arm. Minor headache throughout the day. That afternoon (~3:00pm) noticed itchy neck and face. (Since I had a rash last year from skincare products I just thought it was same thing). March 11, rash worse. Treated with topical 2.5% hydrocortisone ointment. Back of head started feeling tender. March 12, evening, back of head feeling worse, took Ibuprofen. Rash much better on face/neck. Middle of night (March 12), head extremely painful and noticed swollen lymph nodes on back/right side of head. March 13, 8:00am, went to urgent care clinic. Received Cefdinir 300mg antibiotic for unknown infection causing swollen lymph nodes. Rash almost gone. Back of head extremely tender/painful. March 14, swollen lymph nodes multiplied on back of head and also on right side of neck. Saw neighbor anesthesiologist who thought my rash and swollen lymph nodes were caused by the vaccine. March 15, lymph nodes still swollen, but feels more burning/itching like a rash now with occasional throbbing pain. Spreading more in right side of neck, which is sore/tender. Slight rash on neck.
46 2021-03-14 lymph node swelling Lymph node in neck (collar bone area) is swollen on the same side I received the shot on. (Left Arm... Read more
Lymph node in neck (collar bone area) is swollen on the same side I received the shot on. (Left Arm/Side)
46 2021-03-14 swelling face I stayed for 15 minutes and when I was driving home my face started to swell. I had tingling in my... Read more
I stayed for 15 minutes and when I was driving home my face started to swell. I had tingling in my teeth and lips. My throat felt full and I was coughing slightly. Within an hour and 10 minutes after the injection, I started to feel back to normal.
46 2021-03-15 lymph node swelling ENLARGED LYMPH NODES , RED RASH, AND VISIBLE LUMPS IN BREAST ON SAME SIDE OF VACCINATION WHICH LASTE... Read more
ENLARGED LYMPH NODES , RED RASH, AND VISIBLE LUMPS IN BREAST ON SAME SIDE OF VACCINATION WHICH LASTED APPROXIMATELY 2 WEEKS
46 2021-03-15 swelling face, lymph node pain 25 min after shot on my left arm Tingling in my mouth through and face swollen feelings. They gave ... Read more
25 min after shot on my left arm Tingling in my mouth through and face swollen feelings. They gave me two Benadryl?s and 4 Pepcid Waited for a hour in a half Symptoms subsided. Around 9 pm I had horrible pain under my arm pit and top of my breast. And fast heartbeat I took two Tylenol and the pain subsided but I am also getting pain in my two lymph nodes on the left side all the time
46 2021-03-15 swelling face Face burning, severe redness to face, face swelling on the left side, twinge in left side of neck, c... Read more
Face burning, severe redness to face, face swelling on the left side, twinge in left side of neck, chills.
46 2021-03-16 lymph node swelling I awoke in the middle of the night with body pain symptoms, thirst, and slept terribly the rest of t... Read more
I awoke in the middle of the night with body pain symptoms, thirst, and slept terribly the rest of the night. In the morning I had above symptoms, painful lymph nodes in neck and groin, and elevated body temp of 100. But the most significant reaction was swelling and BRUISING around the eyes. Left side definitely worse than the right. I haven't heard of this, so I thought I'd reach out to you.
46 2021-03-16 swelling 03/10/21 injection site got sorer as the day went. Felt a little tired 03/11/21 injection site very... Read more
03/10/21 injection site got sorer as the day went. Felt a little tired 03/11/21 injection site very sore but also felt kinda fatigued and sweating on and off. 03/12/21 woke up at 7:00 a.m with my throat red and tonsils red and lymph node on right side of neck was a-little swollen. Ear hurt on right side. I sounded muffled sounding when talked. I called in sick to work took some Tylenol and went back to bed. I slept all day till 8 p.m got up and ate something and went back to bed. 03/13/21. Throat still sore and red but a little better took Tylenol. Ear hurt on right side as well. 03/14/21 Throat a little better but still felt sore took Tylenol felt energetic all morning and about 5:30 or so felt fatigued. 03/15/21 ear still sore some throat better than before went to work. Had a temp Of 99.1 03/16/21 Sweating on and off today
46 2021-03-17 lymph node swelling Swollen lymph node in right armpit started about a week after the vaccination. It?s been a week and ... Read more
Swollen lymph node in right armpit started about a week after the vaccination. It?s been a week and has not subsided.
46 2021-03-17 lymph node swelling Euphoria (ongoing), golf ball size lymph node in left armpit (ongoing), and short-term menstrual cra... Read more
Euphoria (ongoing), golf ball size lymph node in left armpit (ongoing), and short-term menstrual cramps with light spotting (I have not had a period for over a year, and I haven't had cramps in several years).
46 2021-03-17 swelling Small tender supraclavicular bump; has not noticed any other side effects. feels fine. We rec to use... Read more
Small tender supraclavicular bump; has not noticed any other side effects. feels fine. We rec to use warm compress/NSAIDS and see her MD if this persists past 10 days.
46 2021-03-18 lymph node swelling On March 5, I received my first dose of the Covid shot. Later that day, I was fatigued. Six days la... Read more
On March 5, I received my first dose of the Covid shot. Later that day, I was fatigued. Six days later, however, sometime early morning on March 12, (I was in and out of sleep because of it), I had pain swallowing my saliva on my left side (also the side of my vaccine in my arm). It was hard to pinpoint but the pain came from somewhere at the back of my throat and my ear. If I had to guess what time it was, it probably was around 1-2am that the pain began. March 12, I went to see my primary care doctor. He checked my ears & didn't see any concern. He saw a little redness at the back of my throat but couldn't definitively say what I had. He thought it was a virus but didn?t discount a reaction to the vaccine (although he said it was unlikely since reactions usually happen within 3 days). He ran no tests and didn't prescribe anything. March 13, I was feeling worse. I suddenly had a fever (101 was the highest it ever got), swollen lymph nodes, a white tongue. I went to the local ER at 9am who said I might have oral thrush but he didn?t sound convinced because my tongue wasn't as white o thick as thrush would present (he said for example that typically when you have thrush, you could scrap it off and it would bleed). He diagnosed me with Thrush and Lymphadenopathy. He prescribed anti-fungus medication Clotrimazole 10 mg Troche, five times a day. On Sunday, March 14, my throat pain got worse (it was constant pain v.s. pain only swallowing) so I called the on-call doc who told me to get tested for Strep. The next day, on March 15, I could swallow easier so my doctor didn't think it was necessary. My lymph nodes were still swollen, I had a bit of a fever, and it was still a bit hard to swallow but I was recovering. I had some lingering ear pain. By March 15 I was much better. Today, March 19, I still have a sensation on my left ear/throat area after swallowing but I am much better. Please note that while the ER doctor thought it was fungal and my primary care doctor thought it was viral, neither were sure/thought it was the vaccine. ** Also please note, this is the second time I am completing this because the system booted me off after 20 min the first time and it was erased. It takes times to complete. Just a thought for future reference, it might be helpful to allow for more time.**
46 2021-03-18 swelling 24 Hours after receiving the vaccine my arm was sore from my bicep all the way up to my lower neck. ... Read more
24 Hours after receiving the vaccine my arm was sore from my bicep all the way up to my lower neck. I noticed two bumps near my clavicle, as well that area is swollen.
46 2021-03-19 lymph node swelling, lymph node pain Significant swelling in right armpit (lymph nodes) with mild to moderate pain/ache in same area, goi... Read more
Significant swelling in right armpit (lymph nodes) with mild to moderate pain/ache in same area, going on 2 days now.
46 2021-03-19 swollen extremities Lasting 4 days- Nausea, vomiting, aches, fatigue, fever, chills Lasting 2.5 weeks -Leg edema
46 2021-03-20 lymph node swelling Enlarged and tender lymph nodes in left armpit
46 2021-03-20 swelling face Facial swelling noticed about and hour and a half after shot. Swelling is through entire face but m... Read more
Facial swelling noticed about and hour and a half after shot. Swelling is through entire face but more noted on right hand side. Noted massive headache and dizzy spell twice lasting no more than a minute each time. Taken Benadryl every 6 hours after noticing facial swelling.
46 2021-03-21 lymph node swelling Day after injection: Swollen arm around injection site. Day two after injection: After swelling decr... Read more
Day after injection: Swollen arm around injection site. Day two after injection: After swelling decreased I had swelling under my arm with a knot the size of a golf ball. Very sore and tender to touch.
46 2021-03-21 lymph node swelling Swollen right tonsil, swollen lymph nodes in neck and jaw, pain, no fever, tested negative for strep
46 2021-03-21 peripheral swelling severe thrombocytopenia; Bleeding at Impella insertion site; peripheral swelling in hands/feet; card... Read more
severe thrombocytopenia; Bleeding at Impella insertion site; peripheral swelling in hands/feet; cardiogenic shock; myocarditis; hypoxic respiratory failure; mural thrombus; hypotensive despite pressors; fever; cough; myalgias; This is a spontaneous report from a contactable physician. A 46-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not provided), intramuscularly on 05Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history included hyperlipidemia and COVID-19 pneumonia from an unspecified date in Jan2021 to an unspecified date in Jan2021 (the patient was diagnosed with COVID-19 pneumonia prior to the vaccination. Recovered. Returned to work on 25Jan2021). Concomitant medications included atorvastatin orally at 10 mg, once a day, acetylsalicylic acid (ASPIRIN) orally at 81 mg, once a day, colecalciferol (VITAMIN D); all the drugs were received within two weeks. The patient previously took clindamycin and experienced known allergies: Clindamycin. The patient did not receive other vaccine in four weeks. The patient developed fever, cough, myalgias on 19Feb2021 at 12:00 AM. She developed peripheral swelling in hands/feet on 24Feb2021, she was evaluated in the ER; admitted to (hospital name withheld) on 24Feb2021 with cardiogenic shock, myocarditis, hypoxic respiratory failure. The patient was started on IV vancomycin and Unasyn. TTE (transthoracic echocardiogram) demonstrated LVEF (left ventricular ejection fraction) 35%; reduced biventricular function; mural thrombus on 24Feb2021. Remained hypotensive despite pressors on 24Feb2021. Patient had elevated PCW with preserved cardiac index. Patient underwent VA ECMO (veno-arterial extracorporeal membrane oxygenation) and Impella placement on 25Feb2021. COVID-19 PCR was negative. Blood cultures were no growth. She developed severe thrombocytopenia and developed bleeding at Impella insertion site on 25Feb2021; required multiple, PRBC transfusions. Evaluated for HLH; Soluble IL2 receptor on 26Feb2021 elevated at 7232 pg/mL; ferritin 3054; CRP > 300. ECMO stopped 03Mar2021. The patient was treated with IV antibiotics, mechanical ventilation, pressor support, underwent VA ECMO and Impella placement. The patient was hospitalized from 24Feb2021 to 16Mar2021. Number of days of hospitalization was 20 days. The patient tested COVID post vaccination. The patient underwent lab tests and procedures which included blood pressure: hypotensive despite pressors, LVEF: 35 %, nasal swab: Negative on 24Feb2021, blood cultures: No growth, nasal swab: Negative on 25Feb2021, ferritin: 3054, HLH: Evaluated, Soluble IL2 receptor: 7232 pg/mL (elevated at 7232 pg/mL), CRP: > 300 on 26Feb2021, nasal swab: Negative on 11Mar2021, nasal swab: Negative on 14Mar2021. The events were considered as serious (hospitalization and life threatening) by the physician. The outcome of the events was recovering. Information about lot/batch number has been requested.; Sender's Comments: the events being serious, life threatening and hospitalisation ,medical intervention required are assessed as possibly related to the suspect drug __BNT162B2____ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.
46 2021-03-22 lymph node swelling Small lump in armpit, slightly painful and uncomfortable when lowering the arm. The lump comes and ... Read more
Small lump in armpit, slightly painful and uncomfortable when lowering the arm. The lump comes and goes and so does the pain and discomfort. This started the morning after the vaccine and is still continuing on day two post vaccine
46 2021-03-22 peripheral swelling Swelling of right hand, extreme itchiness, some redness
46 2021-03-23 swelling face Face swelling mainly around the eyelid/eyes that started 9 days after the vaccine was given to me. I... Read more
Face swelling mainly around the eyelid/eyes that started 9 days after the vaccine was given to me. I emailed my GP with pictures and took antihistamine and went through it. It lasted ~ 5 days. Important to note that I have had 2 episodes of face swelling in July and August 2020 of unknown cause. Swelling is gone and
46 2021-03-23 swelling "Covid Toes" The toes on my left foot became red, swollen, blistered and Extremely itchy on the 5th ... Read more
"Covid Toes" The toes on my left foot became red, swollen, blistered and Extremely itchy on the 5th day following my first covid vaccine which lasted for approximately 6-7 days. This occurred again one week following my second vaccine (2nd shot 1/29), for approximately 5 days. It has occurred three times since then, all on the Friday anniversary of my getting the shot. The symptoms for the last 3 times lasted only 2 days, and the redness has decreased, but they are still extremely itchy and have now become scaly at the site of where the most severe itching took place. They do burn occasionally at the site of the scales.
46 2021-03-24 lymph node swelling congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lu... Read more
congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lung; short of breath; left side of my face became numb; tachycardic; Blood Pressure 162/110; chills; burning in my mouth; tingling throughout body; dizziness; fog brain/Memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days; fog brain/Memory loss; muscle pain; bruising not at site (in legs); lymph node swelling on injection arm sight; I finally felt pain at injection site; This is a spontaneous report from a contactable health care professional nurse, the patient. A 46-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899); intramuscular on 20DEC2020 at 22:30 (at the age of 46 years old) as a single dose, for COVID-19 immunization. Medical history included hypothyroid, Allergic to Latex. The patient previously took levonorgestrel and experienced drug hypersensitivity. The patient's concomitant medications were not reported. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 The patient experienced congestion and wheezing in left upper lobe of lung, short of breath, left side of my face became numb, tachycardic, Blood Pressure 162/110, chills, burning in my mouth, tingling throughout body, dizziness, brain/memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days, muscle pain, bruising not at site (in legs), lymph node swelling on injection arm sight and on about the 5th day Dec2020 experienced pain at injection site. The patient underwent lab tests and procedures which included blood pressure: 162/110 on an unspecified date and heart rate tachycardic on an unspecified date. The clinical course is as follows Shortly right at 15 minute mark of being monitored, I became short of breath, left side of my face became numb, then right, became tachycardic, Blood Pressure 162/110, developed chills, burning in my mouth, tingling throughout body, dizziness, developed "fog brain"/Memory loss prevalent for following 48 hours after injection, remained not as severe about a week after, muscle pain, bruising not at site (in legs) developed lymph node swelling on injection arm sight, developed congestion and wheezing in left upper lobe of lung. "felt as if out of body experience" or just not normal for about 12 to 14 days. Patent Refuse to go to ER, where advised to go after RAD team assessed, around the 5th day I finally felt pain at injection site-which that part would be normal, but I did not feel at 1st due to all the major reactions my body dealt with. As a result of the events the patient did visit a physician. Treatment was given for the events (Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, Vaccination site pain) which included Benadryl, Tylenol, IBU, and steroids, Cold and cough meds OTC. The clinical outcome of the events Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, and Vaccination site pain was recovering while blood pressure 162/110 was unknown.
46 2021-03-24 peripheral swelling Follow injection of 1st dose Pfizer, she reports within 1-2 minutes both hands started feeling hot a... Read more
Follow injection of 1st dose Pfizer, she reports within 1-2 minutes both hands started feeling hot and began swelling. Within 5-10 minutes she developed a rash on hands, face, neck and chest. She notified the staff, who provided ice packs for the swelling and placed her in front of a fan. She was monitored for 45 minutes, then released with inst to call 911 if she developed airway problems. She began developing a mild headache. She drove home and took Benadryl 50 mg by mouth, and repeated the dose every 8 hours x 2 additional doses. She took Tylenol for headache. The headache and swelling resolved in 12 hours, and the rash resolved in 16-18 hours.
46 2021-03-24 swelling Tingling sensation in tongue within 2 minutes of injection, swelling of tongue to twice the thicknes... Read more
Tingling sensation in tongue within 2 minutes of injection, swelling of tongue to twice the thickness, itchy mouth, and rapid heartrate within 10 minutes, redness, burning, swelling, and itchy skin on face within 15 minutes. Epi-pen given within 14 minutes, and transport to hospital, wheezing in bases of lungs noted by ER physician and diphenhydramine, famotidine, and solumedrol given. Swelling of tongue took 1.5 hours to reduce to half. Overnight stay at hospital, due to severity and duration of symptoms.
46 2021-03-25 lymph node swelling Metal flavor and swelling tongue, trouble breathing, hives, itching, fast heartbeat, mental confusi... Read more
Metal flavor and swelling tongue, trouble breathing, hives, itching, fast heartbeat, mental confusion, tingling, swelling lymph nodes, body ache, headache.
46 2021-03-26 swelling face, peripheral swelling, swelling On the morning after the second vaccine I woke with swelling of my left eye,face, neck and under arm... Read more
On the morning after the second vaccine I woke with swelling of my left eye,face, neck and under arm/breast area on the left side .By the afternoon all swelling was gone except under the arm. It is uncomfortable to put my arm close to my body and to lay on that side today. It is still sore and swollen today.
46 2021-03-28 lymph node swelling, peripheral swelling Swollen, painful arm, hard lump at injection site, redness, itching, swollen lymph nodes on neck and... Read more
Swollen, painful arm, hard lump at injection site, redness, itching, swollen lymph nodes on neck and armpit on vaccine side, chills, fever of 101.2 for 48 hours, severely painful joints, fatigue. Hot flashes, feeling of chills improved but persists even 5 days after
46 2021-03-28 lymph node swelling Burning, tingling, numbness on left arm, shoulder, face. Most symptoms resolved in 36 hours. Resul... Read more
Burning, tingling, numbness on left arm, shoulder, face. Most symptoms resolved in 36 hours. Resulted in sinus disease left maxillary sinus and swollen lymph glands in neck
46 2021-03-30 high blood cell count Pt with onset of HA and SOB. HA and SOB became so severe she called 911 to get transported to the ED... Read more
Pt with onset of HA and SOB. HA and SOB became so severe she called 911 to get transported to the ED on AM of 3/31/21. Does have hx of Migraines. Has been non-complaint with Migraine prevention meds. But reports this HA feels different and is more severe.
46 2021-03-30 swelling face 3/22 When administered shot body felt a little warm 3/24 Burning pain like a yeast infection or bla... Read more
3/22 When administered shot body felt a little warm 3/24 Burning pain like a yeast infection or bladder infection. Treated at urgent care for a yeast infection 3/25 Woke up with a fever and a rash on my back and chest 3/27 Right side of face was droopy 3/28 Right side of face felt numb, more swollen, droopy, and tingly went to the doctor immediately as worried about Bell's Palsy or worse case a stroke
46 2021-03-30 swelling tingling and numbness at the tip of my tongue, headache, and food taste sweet or spicy such as banan... Read more
tingling and numbness at the tip of my tongue, headache, and food taste sweet or spicy such as bananas and ice cream taste very sugary and fries taste peppery and some foods don't have any taste. 20 minutes after vaccine my tongue felt swollen and under my chin felt swollen. Swelling was mild and went away after an hour or 2.
46 2021-03-31 swelling face Bilateral severely swollen ankles, facial swelling noticed approximately 6-7 hours post vaccine; swe... Read more
Bilateral severely swollen ankles, facial swelling noticed approximately 6-7 hours post vaccine; swelling lasted approximately 3 days.
46 2021-04-01 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Hyperventilation-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient presented with soarness in throat a couple of hours after administration. SHe was taken to the fire department (Uncertain about what treatment was conducted here). Next day, and patient is still not fully recovered. Still has scracthy throat and soreness in her throat.
46 2021-04-01 swelling Patient reported chest tightness post vaccination and then reported feeling dizzy and light-headed a... Read more
Patient reported chest tightness post vaccination and then reported feeling dizzy and light-headed and "shaky" all inside. Angioedema was noted by vaccinator and patient was escorted to the Emergency Department. In the ED, the patient reported chest feeling tight, difficulty swallowing, shortness of breath, and feeling itchy. ED physician noted she was feeling anxious and noted no angioedema and that oxygen saturation was 100% on room air. 50 mg of IV diphenhydramine and 1 mg IV lorazepam were administered. Patient was discharged from the emergency department with a prescription for Medrol dosepak.
46 2021-04-02 lymph node swelling Day 5-lymph nodes in neck/behind collar bone on injection side swelled and became sensitive. Still s... Read more
Day 5-lymph nodes in neck/behind collar bone on injection side swelled and became sensitive. Still slightly swollen on day 17 but sensitivity had faded by day 14; day 7-2?x3? reddened area appeared at injection site; no itching or sensitivity; faded by day 11.
46 2021-04-03 white blood cell count increased, lymph node swelling, swollen extremities She presented to the ER on 2/13 with a lot of chest pain and had some flattening of her T waves. S... Read more
She presented to the ER on 2/13 with a lot of chest pain and had some flattening of her T waves. She ended up getting a cardiac catheterization while she was there which was normal. The day prior to this she had actually received her second Covid vaccination in her left arm. She noticed achiness and soreness across her shoulders bilaterally into her chest and into her neck. She had some subjective fevers and chills and felt generally fatigued. She also had a lot of swelling in her left axilla and she ended up getting a CT scan during her workup which revealed some left axillary adenopathy. She returned to the ER on 3/16: while brushing her teeth, she developed right facial paresthesias that marched over approximately 20 minutes to involve the right arm and the right leg. She went to the hospital. She was seen in the ER. They felt this represented possible ischemia. They gave her tPA. She had a hemorrhagic nosebleed. Did not develop any other signs of bleeding. Her symptoms had not resolved. She was discharged from home. She had a headache at the time of her visit to the ER. Her headache had resolved by the time she was discharged home, but she continues to note paresthesias in the right side of her body, right face, and notes over the last day or 2, she has had increased dysarthria, dizziness and slurred speech, brain fog, a sensation of heaviness and inability to think. She states she currently does not have head pain per se, but she does note that she just feels generally poorly. She feels like her brain is working faster than her mouth muscles are. She is in today for neurologic followup, concerned about these ongoing issues. she continues to struggle with her speech feeling quite slow and deliberate, she feels like it is difficult for her to concentrate, she is forgetful, she still has intermittent episodes of paresthesias in her face, arm, and hand, she feels like she becomes heart and flushed and she has some heart rate variability with her heart going slow and fast, and she has significant disequilibrium. She is extremely fatigued where she is only able to get up for 1-2 hours before she is extremely fatigued and has to go back to bed.
46 2021-04-05 lymph node swelling, lymph node pain Extreme fatigue and muscle aches almost 24 hours after vaccine. At 29 hours after vaccine I started ... Read more
Extreme fatigue and muscle aches almost 24 hours after vaccine. At 29 hours after vaccine I started having chills and headache along with the fatigue, muscle aches . Went to bed and woke up next morning- 36 hours after vaccine, all side effects were gone except tiredness. I noticed my right under arm was sore. I looked in the mirror and it was swollen. Had swollen lymph nodes in right under arm for 2 days after vaccine. Currently 4 days after vaccine and side effects are gone except tired arm on right side which I had the injection.
46 2021-04-05 lymph node swelling Muscle Pain - 2 days Sore injection site - 2 days Swollen lymph node on left side of collar bone - s... Read more
Muscle Pain - 2 days Sore injection site - 2 days Swollen lymph node on left side of collar bone - showed up on April 6, 2021
46 2021-04-05 lymph node swelling Swollen lymph node on throat
46 2021-04-06 lymph node pain, lymph node swelling Enlarged/ painful axillary lymph node of same side as injection site; Enlarged/ painful axillary lym... Read more
Enlarged/ painful axillary lymph node of same side as injection site; Enlarged/ painful axillary lymph node of same side as injection site; This is a spontaneous report from a contactable Nurse. A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 12Feb2021 08:30 (Batch/Lot Number: EL9265) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took fist dose of BNT162B2 (Lot no: EH9899), on 21Jan2021, 09:30 AM Left arm at single dose for Covid-19 Immunization. It was reported that on 12Feb2021 11:00 AM patient experienced Enlarged/ painful axillary lymph node of same side as injection site. There was no covid prior vaccination, there was no covid test post vaccination. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
46 2021-04-06 lymph node swelling Systemic: Lymph Node Swelling-Mild, Additional Details: Pt notes mild lymph node swelling. She has b... Read more
Systemic: Lymph Node Swelling-Mild, Additional Details: Pt notes mild lymph node swelling. She has been alternating Bayer and extra strength Tylenol. Doesn't report pain to touch. She has called her Md who advised that she speak to site where vaccine was administered. She will also try Bendryl for possible histamine response.
46 2021-04-06 swelling Bells Palsy; Swelling in head/swelling from vaccine; headache; dizzy; sore arm; numbness left side o... Read more
Bells Palsy; Swelling in head/swelling from vaccine; headache; dizzy; sore arm; numbness left side of face; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration in left arm on 18Mar2021 13:00 (at the age of 46-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a public health clinic facility. No other vaccine in four weeks. The patient received the first dose of bnt162b2 (lot not reported) in left arm on 24Feb2021 at 14:00 (at the age of 46-years-old) for COVID-19 immunization. Medical history included known allergies: Sulfa. The patient's concomitant medications were not reported. The patient did not have covid prior vaccination and was covid tested post vaccination by nasal swab on 03Mar2021 with result of negative. The adverse events were swelling in head, headache, dizzy, sore arm, numbness left side of face and Bells palsy, all on 19Mar2021 at 01:00. On day 4, went to hospital no stroke or heart attack was told swelling from vaccine. The events were reported to have resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 1 day. Treatment for the events included pain meds, nausea meds. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-04-07 peripheral swelling Headache - feels like my brain is swollen and ready to blow up, stiff neck, collar bone pain, hands... Read more
Headache - feels like my brain is swollen and ready to blow up, stiff neck, collar bone pain, hands and veins feel swollen, feet feel swollen, feel hot inside, sweaty at night, cold when I uncover, cold with no socks, dizzy, threw up, stomach feels gassy and swollen, back hurts, painful to inhale, out of breath, weak, tired, can't sleep, dry phlemy cough, watery nose, watery sticky eyes....my brain feels like it's gonna blow up.... did I say MY BRAIN FEELS LIKE IT'S GONNA BLOW UP!!!!!!
46 2021-04-08 anaphylactic reaction Delayed anaphylaxis. Treated with diphenhydramine and albuterol at 90 minutes post vaccination, epin... Read more
Delayed anaphylaxis. Treated with diphenhydramine and albuterol at 90 minutes post vaccination, epinephrine at 125 minutes post vaccination. Patient release from ER after 4.5 hours, discharged home.
46 2021-04-08 lymph node swelling moderate to severe left supraclavicular lymphadenopathy
46 2021-04-09 anaphylactic reaction Was taken by ambulance diagnoses anaphylaxis Throat swelling itching you get swelling was released a... Read more
Was taken by ambulance diagnoses anaphylaxis Throat swelling itching you get swelling was released after 4 hours with meds given iv steroids iv Benadryl
46 2021-04-09 lymph node swelling it's 10 times worse than when I normally used to have periods.; it's way heavier than ever and I jus... Read more
it's 10 times worse than when I normally used to have periods.; it's way heavier than ever and I just noticed the little lump on my collar bone this morning; I don't normally get my period because I continuously take my pills and I have been bleeding ever since the next day; I have been bleeding ever since the next day and I found a lump on my collar bone, I found a marble sized lump on my collar bone that keeps moving around; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 18Mar2021 (Batch/Lot Number: ER2613) as single dose for covid-19 immunisation. Medical history included allergy from an unknown date. Concomitant medications included montelukast taken for hypersensitivity, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for hypersensitivity, start and stop date were not reported; birth control pills and multivitamins. The patient reported that she got her first shot of the Pfizer Covid vaccine on 18Mar2021 and since then she don't normally get my period because she continuously take her pills and she have been bleeding ever since the next day and she found a lump on her collar bone, she found a marble sized lump on her collar bone that keeps moving around. The period started on 19Mar2021 still goin and it's way heavier than ever and she just noticed the little lump on her collar bone this morning. Her birth control was either Drospire /Ethestr /Lev tab (for further clarification) and she takes it one pill a day. She called her gynecologists yesterday since she was bleeding and they told her to stop taking it the birth control until Sunday and then restart it that's the only thing. She was still experiencing the event and it's 10 times worse than when she normally used to have periods. The patient did not recover from menstrual cycle abnormal and bleeding menstrual heavy while unknown for the other events.
46 2021-04-09 peripheral swelling I got the 2nd vaccine on 4/09/2021. Than I woke up the next morning and arm was sore, through out t... Read more
I got the 2nd vaccine on 4/09/2021. Than I woke up the next morning and arm was sore, through out the day arm became itchy, red swollen, blisters, hot to the touch and very sore. This was around 1pm on 4/10/2021.
46 2021-04-11 lymph node swelling After dose 2, I had my menstrual cycle start one day later, which was one week earlier than it shoul... Read more
After dose 2, I had my menstrual cycle start one day later, which was one week earlier than it should have come. Separately, I had a sharp pain for 24 hours in my left breast. It has been reported that I have intramammary lymph nodes, and may have been associated with that.
46 2021-04-12 anaphylactic reaction skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphyla... Read more
skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphylactic reaction; my throat was closing; my tongue swelled up to the back of my throat; she experienced Body aches; At home she started wheezing; Dry cough; Hoarse voice; Upper airway swelling; Difficulty breathing (without wheeze or stridor); bronchospasm; Respiratory distress; This is a spontaneous report from a contactable other hcp (patient). A 46-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8732), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 10:30 as single dose for COVID-19 immunisation. Medical history included celiac disease and asthma. The patient had allergies to medications, food, or other products. Concomitant medication(s) (received within 2 weeks of vaccination) included levocetirizine dihydrochloride (XYZAL), Dexalant and birth control pill. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26 Mar2021, the patient experienced anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high, my throat was closing, she experienced body aches and at home she started wheezing/bilateral wheeze. Within minutes of receiving the vaccine, my tongue swelled up to the back of my throat and she had a weird sensation in her throat, 15 minutes later she was not able to form words. The patient was given liquid Benadryl (oral) for my tongue swelled up to the back of my throat and her symptoms resolved. She went to the nurse station, who took her BP which was high, which it normally is not so the treating physician felt confident in letting me go home. She was monitored for an hour and was sent home with no more tongue swelling. At home she started wheezing. She called her HCP and was advised to take a nebulizer with no effect. At around 14:00, when the Benadryl wore off, her throat was closing so she was directed to epi-pen herself and call 911. She was taken by ambulance to the hospital and treated for anaphylactic reaction to the vaccine. She was given prednisone 50mg by mouth daily for four days and a refill for her Epipen. No additional Epipen was administered. On 29Mar2021, the patient experienced skin hurting like a neuropathy, chills and she experienced a rash. On an unknown date in Mar2021, she experienced bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor). No sneezing or rhinorrhea. She was treated with adrenaline, corticosteroids, antihistamine, IV fluids, Oxygen, bronchodilators and other. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The administering doctor not to take the second vaccine. The outcome of the events anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high and my throat was closing was recovered with sequealae, skin hurting like a neuropathy, she experienced body aches, at home she started wheezing/bilateral wheeze, chills and she experienced a rash was recovered and bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor) was unknown. Follow up attempts are needed. Information on lot /batch number was obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-04-12 lymph node pain, lymph node swelling Swollen painful lymph nodes in neck for approximately 12 hours.
46 2021-04-12 swelling Initial stomach discomfort beginning minutes after injection. 2-3 days of digestive issues most seve... Read more
Initial stomach discomfort beginning minutes after injection. 2-3 days of digestive issues most severely blood in stool that cleared up after a few days. Beginning around 4/3/21 began to have a sore between two toes along with redness and swelling and other redness in hands/wrists and around one eye. Doctor prescribed Antibiotic and antihistamine via tele-med video visit.
46 2021-04-13 c-reactive protein increased Pt developed flu like symptoms within 24 hours of second dose of Pfizer COVID vaccine on 3/5/21 whic... Read more
Pt developed flu like symptoms within 24 hours of second dose of Pfizer COVID vaccine on 3/5/21 which included fever, body ache, headache, and chest pain. The chest pain was severe and on 3/7/21 she sought evaluation in the Emergency Room. She was found to have an elevated troponin test (repeated x 3), and T wave abnormalities on EKG concerning for a NSTEMI. CRP was also elevated. It was recommended that she be admitted to the hospital but she left the ER against medical advice.
46 2021-04-13 lymph node swelling 4/9 - Sore arm at injection site 4/10 - Sore arm, swollen lymph node in armpit of injection site, mi... Read more
4/9 - Sore arm at injection site 4/10 - Sore arm, swollen lymph node in armpit of injection site, mild itching around injection site and in armpit of injection site 4/11 - continuation of symptoms from 4/10 4/12 - continuation of symptoms from 4/10, itching subsided 4/13 - Swollen lymph node in neck on side if injection site
46 2021-04-13 swelling No typical symptoms after first shot. Four weeks after first shot noticed fluid/non-boundary lump at... Read more
No typical symptoms after first shot. Four weeks after first shot noticed fluid/non-boundary lump at base of neck on left side, behind collar bone. (Almost perfectly circular, about one and a half to two inches in diameter, pushing up about one half to one inches above normal surface of skin. Very soft and pliable - no noticed boundaries, sacks, "lumps", etc.
46 2021-04-14 lymph node swelling Headache 14 hours Fever 36 hours Rash on injection arm 5 days Swollen lymph node injection side 7 da... Read more
Headache 14 hours Fever 36 hours Rash on injection arm 5 days Swollen lymph node injection side 7 days but decreasing daily
46 2021-04-14 lymph node swelling Fever Aches Headache Stomach ache Muscle cramps Swollen lymph node in arm pit
46 2021-04-14 lymph node swelling Both lymph nodes under both arms been swollen for last two weeks but producing much burning pain and... Read more
Both lymph nodes under both arms been swollen for last two weeks but producing much burning pain and spasm in muscles in chest. And shivering inside at night in particular. Some shooting muscle pain in legs early on. Fading last day a bit. Had to get muscles relaxants and strong antiinflamatory but getting batter last day on just Tylenol. Had to get heart and chest X-ray but all looks normal. Saw doc twice. Believing it will get better soon as doc said it should subside bc had to postpone second shot til a week later April 26.
46 2021-04-15 lymph node swelling Chills, aches swollen lymph node in neck and sore next on injection side
46 2021-04-15 swelling face Face felt flush, irritated by mask. But after mask was removed my face continued to appear red and f... Read more
Face felt flush, irritated by mask. But after mask was removed my face continued to appear red and feel hot to the touch (no fever). (Both sides). Swelling of face became more evident (mostly cheeks) over the next two hours.Flush areas of face also felt numb/tingly. Mouth also felt numb-teeth felt like after dentist anestheic injection. began about 10:50, peaked around 1pm maybe. By 4 felt mostly normal. Face stayed flush looking after no longer felt hot or numb. Just fatigue after. Also some swelling/numbness at site of injection. But more mild.
46 2021-04-16 peripheral swelling on 4/16/2021 @ 4:42AM I woke up with severe pain in my finger tips; swelling and burning (at the tim... Read more
on 4/16/2021 @ 4:42AM I woke up with severe pain in my finger tips; swelling and burning (at the time no redness). Today, 4/17/2021, my finger tips have painful red blisters on them (feels like they are on fire). Ring and Pinky fingers on my left hand are numb at the finger tips down to the second knuckle (on each finger). I have taken (1) 81mg children chewable aspirin this morning at 8:00AM; at 12:00PM I took (1) 500mg pill of Tylenol and repeated the Tylenol at 4:00PM & 10:00PM. They haven't worked at all with the fiery pain, swelling, nor the blistering redness on my finger tips.
46 2021-04-17 swelling face 24 hours after shot,Body aches. & headache day of. After shot face swelling sore cheeks like I was h... Read more
24 hours after shot,Body aches. & headache day of. After shot face swelling sore cheeks like I was have an allergic reaction. Sleepiness
46 2021-04-18 lymph node swelling 101F fever; chills; headache; fatigue; swollen lymph nodes in armpit and right clavicle; This is a s... Read more
101F fever; chills; headache; fatigue; swollen lymph nodes in armpit and right clavicle; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 01Apr2021, at 15:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient medical history included Obesity, Hypothyroidism and High blood pressure. Allergies to medications, food, or other products was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included levothyroxine, amlodipine and rosuvastatin. The patient had not received any other vaccine within 4 weeks prior to the vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) in right arm, on 11Mar2021 at 15:00 for COVID-19 immunization. On 01Apr2021, at 21:00 the patient experienced 101F fever, chills, headache, fatigue, swollen lymph nodes in armpit and right clavicle. The therapeutic measures were taken as a result of events include extra sleep, extra fluids and acetaminophen. The patient underwent laboratory tests and procedure included body temperature resulted in 101 Fahrenheit on 01Apr2021. The outcome of the events was recovering. Information about batch/Lot number has been requested.
46 2021-04-18 lymph node swelling Dizzy left arm numb, metallic taste, had to keep swallowing? Swollen glands under chin on neck
46 2021-04-18 swelling, lymph node swelling 2 days ago, I developed a few small itchy bumps under my chin & swollen lymph nodes on the right si... Read more
2 days ago, I developed a few small itchy bumps under my chin & swollen lymph nodes on the right side of my neck. I went to the doctor today & was diagnosed with shingles. He prescribed me Valtrex to help with duration of pain & help stop the spreading.
46 2021-04-19 axillary mass Large painful lump under armpit on the side the vaccine was given. Started with pain 12 hours after... Read more
Large painful lump under armpit on the side the vaccine was given. Started with pain 12 hours after vaccine, progressed to a lump the size around of a baseball. After 3 days, slowly started getting smaller and a little less painful-taking ibuprofen still
46 2021-04-19 lymph node swelling Day of headache (Sun), that night sore arm, and next day some sleepiness, but that doesn't concern m... Read more
Day of headache (Sun), that night sore arm, and next day some sleepiness, but that doesn't concern me. What does it Thurs (~Day5) afternoon, it felt like my tongue was getting "thick" and pressing my back teeth, then I noticed that the lymph node on the left side of my throat began to really swell. It got really enlarged by Friday evening (~ Day 6) to the point that I wondered if I had tonsillitis - no pus/not strep. But being only on the left side (same as shot) and not both, I figured that it could be a reaction. Called my after-hours doctor on Sat who confirmed that this did sound very much like a reaction (not much to be found online) and nothing to be too concerned about unless it didn't resolve in a few days. Swelling went down significantly by Sat. a.m. and was back to normal by Sun (Day 8).
46 2021-04-19 lymph node swelling Fever Body aches Swollen lymph nodes Headache Fatigue
46 2021-04-19 oral herpes Cold Sore outbreak on lip. The last one I had was over 5 years ago. Then I had an outbreak 2 days af... Read more
Cold Sore outbreak on lip. The last one I had was over 5 years ago. Then I had an outbreak 2 days after receiving the 1st Pfizer dose. I took Valtrex for the following 4 days to keep it at bay.
46 2021-04-20 lymph node swelling 1st dose- arm soreness, headache, horse throat 2nd dose- arm soreness, headache, fatigue, nauseous,... Read more
1st dose- arm soreness, headache, horse throat 2nd dose- arm soreness, headache, fatigue, nauseous, muscle ache, chills, swollen under arm lymph node (L) Mass on left thyroid lobe
46 2021-04-20 lymph node swelling Extreme fatigue swollen lymph nodes And a stye/chalazion (I?m fine- reporting in case other people e... Read more
Extreme fatigue swollen lymph nodes And a stye/chalazion (I?m fine- reporting in case other people experienced these things as well)
46 2021-04-21 lymph node swelling Body Aches, left arm lymph node is swollen and rash developed in left arm
46 2021-04-21 swelling face Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: numbness under tongue l... Read more
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: numbness under tongue left side, jaw left side, forhead left side novacaine like feeeling-Medium, Additional Details: left side under tongue numb, left jaw numb, forhead numb decreased with administration of benadryl butr did not go away 1.5 hors post shot. pt states feels like when she gets novacaine at dentist..tingly as well\r\n
46 2021-04-21 swelling Report left thumb pain started with 15 minutes of receiving the vaccine and resolved 15 minutes afte... Read more
Report left thumb pain started with 15 minutes of receiving the vaccine and resolved 15 minutes after receiving the vaccine. Report today 4/22/21 constant pain of the left thumb, report pain with movement, and mild swelling. Treatment: Tylenol with no improvement. Outcome: Does not interfere with ADLs, will continue to monitor and follow-up with primary doctor if worsens
46 2021-04-21 swelling Superficial blood clot in right leg two large hot swollen spots
46 2021-04-22 guillain-barre syndrome Guillian Barre Syndrome
46 2021-04-22 lymph node swelling, lymph node pain A large lump near my collar bone. The lump was tender to the touch. Also, in addition to arm sorene... Read more
A large lump near my collar bone. The lump was tender to the touch. Also, in addition to arm soreness, I was unable to turn my neck to the left. Felt like a pinched nerve.
46 2021-04-22 lymph node swelling Parotid Gland/Lymph Node Swelling. Significant swelling on left side. Unable to eat due to swelling... Read more
Parotid Gland/Lymph Node Swelling. Significant swelling on left side. Unable to eat due to swelling for two days.
46 2021-04-22 lymph node swelling Swollen lymph nodes in armpit in arm that received shot. Very sore to touch and move. Swelling an... Read more
Swollen lymph nodes in armpit in arm that received shot. Very sore to touch and move. Swelling and tenderness went from exterior (back) of armpit to interior (front) of armpit near the breast.
46 2021-04-22 lymph node swelling Events: 12:00 PM Fatigue and fever of 100.2 10:00 PM Covid Rash (red splotch on injection arm) tha... Read more
Events: 12:00 PM Fatigue and fever of 100.2 10:00 PM Covid Rash (red splotch on injection arm) that is 10 degrees warmer than the rest of my arm - symptom continues 10:00 PM Observed enlarged underarm lymph node under injection arm - symptom continues Treatments: Fatigue & fever = Sleep Rash & lymph node = nothing at recommendation of physician Outcomes: Fatigue & fever = gone in 4 hours after sleep Rash & lymph node = wait 2 weeks after injection to determine next steps if they are still an issue
46 2021-04-22 swelling Swelling and pain at the base of left side of the neck. Very tender to the touch. Swelling diminis... Read more
Swelling and pain at the base of left side of the neck. Very tender to the touch. Swelling diminishing on day 3 but still very sore.
46 2021-04-23 axillary mass Under right armpit a lump. I have taken TAYLEnol since Friday.
46 2021-04-23 lymph node pain, lymph node swelling Severe Headache, nausea, exhaustion morning after injection (4/23/21) . Under lt armpit & into breas... Read more
Severe Headache, nausea, exhaustion morning after injection (4/23/21) . Under lt armpit & into breast are (lymph nodes) swollen & painful morning of 4/24/21. Lt arm tender at site remains. Injection done 4/22/21
46 2021-04-23 lymph node pain, lymph node swelling Swollen lymph nodes under left arm Sore lymph nodes under left arm
46 2021-04-23 swelling face Diarrhea, swollen of lips and face , stomach pain. Second day now
46 2021-04-24 swelling swelling of her ovaries; hot to the touch; on the opposite side, so the right side, on her lower bac... Read more
swelling of her ovaries; hot to the touch; on the opposite side, so the right side, on her lower back in that area it was also swollen and hot to the touch; This is spontaneous report from a contactable consumer(patient) reported for herself. A 46-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot Number: Unknown) as SINGLE DOSE, dose 2 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swelling of her ovaries, hot to the touch, on the opposite side, so the right side, on her lower back in that area it was also swollen and hot to the touch, all on 18Mar2021 with outcome of not recovered. Patient has received both the first and second dose of the Pfizer Covid Vaccine. Stated she got her second dose yesterday and with both dose of the vaccine, she had swelling of her ovaries and they were hot to the touch. Stated it was more on the right than the left. Stated it was worse the first time. States on the opposite side, so the right side, on her lower back in that area it was also swollen and hot to the touch. The patient experienced events after first dose from 18Mar2021 and recovered on 20Mar2021, experienced same events after second dose on 08Apr2021 and ongoing. Time of Onset (24-hour clock) reported as noticed it this morning and got up around 05:40. The events reported as non-serious. No Emergency Room visit. No Physician Office visit, stated she worked for a dentist and she consulted with her and the dentist said to watch it and wait 48 hours. Treatment received included Ibuprofen. No follow-up attempts are needed. No further information is expected. Information about lot/batch number cannot be obtained.
46 2021-04-25 lymph node swelling Second dose of Pfizer-BioNTech vaccine caused some expected lymphadenopathy on the side in which vac... Read more
Second dose of Pfizer-BioNTech vaccine caused some expected lymphadenopathy on the side in which vaccination was given. Had a longstanding appointment for a mammogram that took place approx 36 hours after second dose received. Accordingly, ultrasound revealed lymphadenopathy and necessitate a follow-up U/S. Further follow-up will be given in eight weeks to ensure resolution, further to current supposition that the swelling is related to a normal reactivity of lymph nodes following vaccination. I understood already that this was a possibility, given the proximity of the second COVID-19 vaccination and the mammogram, but wanted to report outcome, to add to dataset.
46 2021-04-26 peripheral swelling, swelling The day after receiving the first vaccine, my fingers and toes on both sides became swollen and pain... Read more
The day after receiving the first vaccine, my fingers and toes on both sides became swollen and painful. Even now, four weeks after the first vaccine, my fingers are two ring sizes swollen, and my toes are swollen. There is constant pain in the joints in my fingers and toes. Also, I developed a sharp, intermittent shooting pain behind my right breast one day after receiving my second Pfizer vaccine on April 19.
46 2021-04-27 anaphylactic reaction Anaphylactic reaction; a lot of "brain fog"; Diarrhea; Her hip pain has gotten progressively worse; ... Read more
Anaphylactic reaction; a lot of "brain fog"; Diarrhea; Her hip pain has gotten progressively worse; This is a spontaneous report from a contactable consumer via Program. The 46-years-old female consumer (patient) received BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown,) on 19Mar2021 via an unspecified route of administration as a single dose for COVID-19 immunization. The medical history and concomitant medication were not reported. The other medication included XELJANZ XR TAB 11MG since 28Jul2020. Patient reported that she had an anaphylactic reaction to her first Pfizer COVID-19 vaccine on 19Mar2021. Since this reaction she has had a lot of brain fog and diarrhea, that was not happening before the reaction. Patient also said that her hip pain has gotten progressively worse and affecting her ability to dress herself. Further patient explained she will miss 2 doses of Xeljanz before she receives the medication on 15Apr2021. The outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-04-28 lymph node swelling, lymph node pain Swollen lymph nodes under left arm within armpit and also in groin area. Both significant and painfu... Read more
Swollen lymph nodes under left arm within armpit and also in groin area. Both significant and painful. The armpit one went away after two days. The groin one remains. Also noticing changes to menstrual cycle flow and it started earlier than normal this month.
46 2021-04-28 lymph node swelling Severe, debilitating upper abdominal pain immediately under the rib cage that spanned fully across t... Read more
Severe, debilitating upper abdominal pain immediately under the rib cage that spanned fully across the abdomen. Abdominal swelling, tenderness upon touch. Onset around midnight the same day of the vaccination. Continued for 8 - 12 hours. Pain then abated but upper abdomen remained tender and distended for roughly 24 more hours. Also significant lymph node swelling under arm pits. Lasted approximately 1 week under right arm, 2 + weeks under left arm (arm where vaccinated).
46 2021-04-28 swollen extremities Had general body aches and right arm pain but then 30 hours or so after the shot, I noticed a large ... Read more
Had general body aches and right arm pain but then 30 hours or so after the shot, I noticed a large lump under my right arm. It is large and very sore and is uncomfortable to move arm. About 2-3 inches in diameter.
46 2021-04-28 peripheral swelling rash, swollen hand, burning sensation on hand (not injection site)
46 2021-04-28 swelling It was the 1st dose after talking to the doctor on site and they put me in for extra observation (30... Read more
It was the 1st dose after talking to the doctor on site and they put me in for extra observation (30 Mins). Within 12 minutes I had an allergic reaction and I spent a good two hours plus with them and now I am on the CDC watch app. The two paramedics plus doctor said they had never seen a person have all the symptoms in one shot, till they met me. The doctor said he was amazed at how sensitive my body was to the medicine but was very impressed that I had all my medications, allergic reactions and so on digitally. I go for the 2nd/final shot on 4/29 so hopefully that one doesnt have me down for days bc I leave for the DR on 5/1. I have been home and recovering sine Thursday. I had a fever, chills, my arm went numb, then I had swelling/redness and sore to the touch, chest palpitations, my asthma kicked in with the wheezing, my blood pressure sky rocketed, my sugar jumped up to 300, fatigue, tiredness, then the itching started and diarrhea. Just a lot going on from one shot.
46 2021-04-29 lymph node pain, lymph node swelling My lymph nodes in my left armpit were engaged. It felt and looked like I had a small water balloon ... Read more
My lymph nodes in my left armpit were engaged. It felt and looked like I had a small water balloon in my left armpit. It was painful to lay on my side. After 7 days, the swelling is gone but putting deodorant on is still tender. in addition, my energy levels went up and down over a 7 day period. Some days getting through work was challenging, even though I was working remotely. Almost 10 days out, I don't feel 100% of where I was before the vaccine.
46 2021-04-29 lymph node swelling Herpes zoster (Shingles) diagnosis on day 5 due to immune response to Pfizer vaccine, rash appeared ... Read more
Herpes zoster (Shingles) diagnosis on day 5 due to immune response to Pfizer vaccine, rash appeared overnight day 4 to day 5. Emergency room visit evening day 3 for extreme numbness in hands and feet in addition to the following: Shooting pains like a wasp was flying around in my body 30 minutes after and still occurring 5 days later. Intense skin itching from day 1 and still occurring 5 days later. Pins and needles sensation in extremities from day 1 and still occurring 5 days later. Hands and feet feel as if they are asleep/numb from day 1 and still occurring 5 days later. Lymph nodes swollen from day 2 and still occurring 5 days later.
46 2021-04-30 swelling angioedema of left lower lip; This is a spontaneous report from a contactable consumer. A 46-year-ol... Read more
angioedema of left lower lip; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729, expiration date not reported), via an unspecified route of administration, administered in the left arm on 09Apr2021 17:00 at single dose for covid-19 immunisation. Medical history included asthma, degenerative disc disease, migraines, allergies: shellfish intolerance, nickel allergy, skin allergy to some kind of plastic/foam. The patient was not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); sertraline; ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE); fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); minocycline. The patient experienced angioedema of left lower lip on 16Apr2021 01:00. The patient was given methylprednisolone 4 mg dose pack as treatment for the event. The patient has no prior vaccination and no covid test post vaccination. The patient had not recovered from the event at the time of the report.
46 2021-04-30 lymph node swelling my lymph nodes on my left side began to swell and now they are both swollen the left and the right a... Read more
my lymph nodes on my left side began to swell and now they are both swollen the left and the right and the neck area:; pain in her throat; pain in her ear; felt fatigue for 1 day; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6207, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date at a single dose for covid-19 immunisation. The patient historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6203, Expiry date: unknown), via an unspecified route of administration on 05Mar2021, at single Covid-19 immunization. Patient medical history included breast cancer survivor, blood pressure high and cough. Patient concomitant medications included paracetamol (TYLENOL), candesartan cilexetil, felodipine (ATACAND COMB) taken for High Blood pressure, letrozole (LETROZOLE) taken for cancer it was estrogen blocker, celecoxib (CELEXA [CELECOXIB]) and benzonatate (TESSALON PERLE), all concomitant medications start date stop date was unspecified. After receiving the first dose of the vaccine, she had swollen lymph nodes under her arm pit. After receiving the second dose of the vaccine, she had swollen lymph nodes, pain in her throat, pain in her ear and felt fatigue for 1 day. She took Tylenol for 5 days. She added that last Thursday, her lymph nodes were swollen on both sides. She saw her doctor, Patient underwent lab test and procedure which included ultrasound and told her it was likely due to the vaccine. She mentioned that she is a breast cancer survivor. The patient stated that she is calling because she wanted to report a reaction and she wanted to see if they have heard of those reaction before due to the COVID vaccine, swollen lymph node on the vaccine site. When again probed for the concern, the patient stated that swollen lymph node on the left side and on the right side. She got the vaccine on the left side, but it started on the left side. When paraphrased the above concern, the patient stated that this was a reaction swollen lymph node. It was like her 'neck' and her throat and ear were hurting for like 5 days and then like two weeks after the vaccine her lymph nodes on her left side began to swell and now they are both swollen the left and the right and the neck area. The patient stated that from the next day she had pain in her throat and in her ear and then it lasted for like 5 days. She had pain in her ear and her throat and on last Thursday she does not know what date it was, but it was the first day, on that day she had swollen node on left side like 3 swollen lymph nodes, so she went for ultrasound. She asked whether people have been reporting this as a side effect. The patient added that from the first vaccine she had like node under her armpit hurting, to the first dose. It was painful under the armpits like lymph nodes under the armpits. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected. Follow up (14Apr2021): New information received from a contactable consumer in response to Non-HCP letter sent to consumer included: Updated the concomitant medications (paracetamol (TYLENOL), candesartan cilexetil, felodipine (ATACAND COMB), letrozole (LETROZOLE), celecoxib (CELEXA [CELECOXIB]) and benzonatate (TESSALON PERLE), medical history (Blood pressure high and cough) and clinical details.
46 2021-04-30 peripheral swelling Pt got 2nd Pfizer shot on Thur 4/29/21 in left arm. Came in today to report swelling, redness, warmt... Read more
Pt got 2nd Pfizer shot on Thur 4/29/21 in left arm. Came in today to report swelling, redness, warmth, and itching below the injection site, and axillary tenderness. Pt stated reaction started just this morning. Pharmacist suggested Tylenol, ibuprofen and cool compress, and to report to PCP if condition worsens.
46 2021-04-30 peripheral swelling swelling of the fingers; itchiness on her palm; This is a spontaneous report received from a contact... Read more
swelling of the fingers; itchiness on her palm; This is a spontaneous report received from a contactable physician. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot# unknown), via an unspecified route of administration on 18Apr2021 (at the age of 45-years) as single dose for COVID-19 immunization. Medical history included multiple sclerosis (was a high-risk patient), hypertension, anaphylactic reaction (allergic to Cephalosporins and Steroids) all events are ongoing. Concomitant medication included diovan, immunoglobulins. The patient previously took benadryl for hypersensitivity. Patient took 50 Mg of Benadryl before her first dose. On 18Apr2021 (7-hours of the vaccine), the patient had swelling on her fingers, itchiness on her palm. Patient then took 25mg of Benadryl and took a nap for about 4 hours, when she woke up the swelling and itching were completely gone. The patient received the unspecified treatment for events. The seriousness for event was reported as non-serious by physician. The outcome of the events was recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
46 2021-04-30 swelling face Facial swelling.; Some swelling in mouth on right side.; This is a spontaneous report from a contact... Read more
Facial swelling.; Some swelling in mouth on right side.; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received second dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration, administered in right arm on 12Apr2021 at 16:15 (at the age of 46 year old) as single dose for Covid-19 immunization. The patient's medical history included seafood, antibiotics, and shellfish allergy. The patient's concomitant medications were not reported. The patient previously took 2 Benadryl before vaccination. Patient historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration as single dose for COVID-19 immunization and experienced facial swelling. The patient did not take any other medication within two weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, it was unknown if patient was diagnosed with COVID-19. It was unknown whether the patient had been tested for COVID-19 since the vaccination. On 12Apr2021 at 17:45, the patient experienced facial swelling and some swelling in mouth on right side. The patient did not receive treatment for events. The outcome of the events recovering. No follow-up attempts are needed. No further information is expected.
46 2021-05-01 lymph node pain, lymph node swelling Woke up 48 hours after vaccination with pain, tenderness, and swelling on left side near collarbone/... Read more
Woke up 48 hours after vaccination with pain, tenderness, and swelling on left side near collarbone/neck- subclavical lymph node? Approx 2" diameter. Vaccination was in left arm , approx 1.5" below shoulder
46 2021-05-01 swelling Immediately following vaccine I experienced rapid heart rate, small tightness in chest, and shortnes... Read more
Immediately following vaccine I experienced rapid heart rate, small tightness in chest, and shortness of breath. I had to remove my mask to breathe. I stood from feeling my heart race, but then felt dizzy and sat again. It felt exactly like what happens when I eat shellfish, only it eased faster. Symptoms improved after five minutes of deep slow breathing. My heart raced longer, than five minutes but were not bothersome after five minutes. The attendant watched me the full half hour and was prepared with epinephrine if my airway swelled. He offered me benadryl, but i took it at home instead. That night my neck swelled slightly around my thyroid and my throat felt itchy. . I took two Benadryl and went to bed. Today the right side of my face is slightly numb, but moves normally and is not drooping. I have had bells palsy immediately after 2009 H1N1 vaccine, and same allergic response hr and breathing after varicella vaccine. All other vaccines have not been a problem.
46 2021-05-02 peripheral swelling, swelling face At approximately 1415, patient reported minor swelling/numbness traveling from her left arm up to th... Read more
At approximately 1415, patient reported minor swelling/numbness traveling from her left arm up to the left side of her face. Patient advised to wait for further observation. At approximately 1430, patient reassessed. Patient had no difficulty breathing. Lead nurse educated patient educated on signing up with V-Safe, seeking emergency care for any difficulty swallowing/breathing, and following up with primary care provider about her reactions to the vaccine.
46 2021-05-02 peripheral swelling Congestion, fever, common cold, severe neck pain, swelling and pain in index finger, headache
46 2021-05-02 swelling, swelling face Beginning Tuesday April 13, 2021, the right side of my face begin to swell. As the week went on, I s... Read more
Beginning Tuesday April 13, 2021, the right side of my face begin to swell. As the week went on, I started breaking out into hives on the right side of my head, face and my upper back. I started feeling throbbing pain in my head and the swollen area of my face. On Sunday, April 18, 2021, I started to feel better with the help of taking 2 Tylenol 500 mg every 6 hours. As of today, the top of my head hurt and when I scratch my head on the right side it feels like Im scratching with razors. Also, I still have a little swellen under my earlobe on the right side. I was scheduled to take my second dose today, but I am afraid that I will have the reaction that I had with the first dose. Please advise
46 2021-05-03 lymph node swelling, lymph node pain 9pm same day of shot - ringing ears, sweating, dizziness 8am next morning/day after - lymph nodes i... Read more
9pm same day of shot - ringing ears, sweating, dizziness 8am next morning/day after - lymph nodes in neck around face, behind ears, and in arm pits are very large, swollen and painful . Hives on left arm. Red blotchy spots and welts on bottom half of both legs, very itchy.
46 2021-05-04 lymph node pain Throwing up; nausea; chest pain & tightness to the point I could not move my arm to use my emergency... Read more
Throwing up; nausea; chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID/ I couldn't move; tremor increased; post COVID syndrome & orthostatic hypertension.; post COVID syndrome & orthostatic hypertension.; Lymph node pain; Tilt Table Testing confirmed Covid-induced POTS; mild injection site pain; COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain).; chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID; dizzy; Fatigue; vasovagal response; Passed out; This is a spontaneous report from a contactable other health professional (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Feb2021 at 10:30 (Lot Number: EL9261) (at the age of 46-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included infectious mononucleosis (Recent mono) in 2020 (Spring), urinary tract infection (UTI) in 2020 (Summer), venous Insufficiency on Dec2020, shingles in past on an unspecified date, lactose & gluten intolerance from an unknown date and unknown if ongoing, COVID-19 from Jun2020 to an unknown date (I had recovered from mild COVID in Jun and Oct2020 that required no hospitalization and was managed with DAYQUIL, XYZAL, Prednisone, Vit D and melatonin). Concomitant medications included ibuprofen at 2400 mg and 800 mg; pregabalin (LYRICA); progesterone; bifidobacterium bifidum/bifidobacterium lactis/bifidobacterium longum/lactobacillus acidophilus/lactobacillus rhamnosus (PROBIOTIC), all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient experienced mild injection site pain, COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain), dizzy, fatigue, vasovagal response, passed out, nausea, throwing up, tremor increased, chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID/ I couldn't move, post COVID syndrome and orthostatic hypertension, tilt table testing confirmed COVID-induced POTS (postural orthostatic tachycardia syndrome) and lymph node pain, all on 05Feb2021 at 11:00. All events were serious disabling and required hospitalization. The patient underwent lab tests and procedures which included computerized tomogram (CT): unknown results on an unspecified date, D-dimer: 1300 is very elevated, it shows that I have a lot of inflammation in my body or I could have the clot, 1300, almost 3 times the normal value; magnetic resonance imaging head (MRI): unknown results on an unspecified date, SARS-COV-2 test (nasal swab): negative on 19Feb2021, tilt table test: COVID-induced pots on 05Feb2021 . Unspecified therapeutic measures were taken as a result of the events. The patient outcome of the event passed out was unknown and not recovered for all the other events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-05-04 lymph node swelling Swelling and severe itching on injection arm; blistering around injection site; redness. Pain radia... Read more
Swelling and severe itching on injection arm; blistering around injection site; redness. Pain radiating down arm and up neck. Swollen painful lymph nodes under arms and in neck (worse on side of injection) Treatment: benedryl and tylenol/advil. significant swelling and itching, blistering and lymph node swelling resolved on 5/42021. Minor itching and radiating pain continue, but are lessened by advil/tylenol and benedryl.
46 2021-05-04 swelling face, swelling Patient presents with a potential reaction to the COVID19 vaccine. The patient reports a sensation o... Read more
Patient presents with a potential reaction to the COVID19 vaccine. The patient reports a sensation of swelling around her L-sided face and neck with itching, but with no airway compromise. The patient has a history of facial swelling after a flu vaccine for which she was hospitalized. While the patient didn't have any clear sign of swelling on exam, 50mg of Benadryl IM was given as the patient had already taken OTC Zyrtec with no effect, and given her body habitus for improved absorption in a timely manner. AMR gave 50mg IM Benadryl given in R deltoid and tolerated well. With close monitoring and above intervention, symptoms resolved and patient was returned home with her partner as the driver.
46 2021-05-09 anaphylactic reaction Eye swollen closed, throat scratchy and swollen. Per ED MD, severe allergic reaction consistent with... Read more
Eye swollen closed, throat scratchy and swollen. Per ED MD, severe allergic reaction consistent with anaphylaxis. Also has allergy to ibuprofen and reports took some earlier today; mistook the brand name for acetaminophen.
46 2021-05-09 lymph node swelling, lymph node pain, swelling Swollen and rash from shot, vomiting anything I eat, lymph node on left arm where I got 2nd sore swo... Read more
Swollen and rash from shot, vomiting anything I eat, lymph node on left arm where I got 2nd sore swollen and painful, can?t keep any food down since Friday. Already lost 5 lbs, hard trouble breathing today. I took my Valium it didn?t help. My Arm still isn?t not feeling better or swelling going down or rash gone. Started around 5pm same day as shot
46 2021-05-09 lymph node swelling Swelling in the lower right arm pit, sore and tender to the touch, accompanied by runny nose and som... Read more
Swelling in the lower right arm pit, sore and tender to the touch, accompanied by runny nose and some drainage in the ear for 1 day. Arm pit was swollen for 3 days after which the swelling went down but site was still tender to the touch for 2 weeks. Right arm pit feels a little different than left based on self examination.
46 2021-05-09 peripheral swelling After two days, my arm began to swell, itch, turned red and felt hot to the touch.
46 2021-05-10 lymph node swelling body aches; headache; nausea; chills; sore arm; swelled lymph node under the arm; This is a spontane... Read more
body aches; headache; nausea; chills; sore arm; swelled lymph node under the arm; This is a spontaneous report from a contactable other health care professional. A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 15Apr2021(at the age of 46-year-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient experienced body aches, headache, nausea, chills, sore arm and swelled lymph node under the arm the evening after receiving the second dose on 15Apr2021. The outcome of the events (body aches, headache, nausea, chills, sore arm) was recovered on 17Apr2021 and swelled lymph node under the arm was recovered on 22Apr2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-05-11 lymph node swelling, peripheral swelling Instant swelling of the left lymph node ( visibly seen by witness and was compared to the size of a ... Read more
Instant swelling of the left lymph node ( visibly seen by witness and was compared to the size of a lemon) and swelling of right (minimal) closing throat, inability to swallow and challenge to breathe, tingling in hands, 90% loss of muscle strength in legs, heart palpitations (over 90 bpm - avg. 62), loss of concentration and low Co2, and flushed/redness in skin on neck, face, hands, back. I had many witnesses and 2 called 911 thinking it was anaphylactic shock with continuous throat swelling. Paramedic said that it did not appear to be an allergic reaction but could clearly see my lymph nodes swelling. Provided oxygen, Benadryl, IV and blood tests. No infection was found and no food allergy in past. I could not move my legs for a couple of hours but eventually had swelling, muscle strength decrease and return back to normal by the end of the evening. My first dose had no symptoms. However, I placed my hormone patch on the same arm of the second vaccine that week (*note -have used for over a year with no adverse reactions). Possibility of lymph node overdrive or anaphylactic shock with the combo? Should be looked into. Very serious, life threatening event.
46 2021-05-12 swelling face Patient experienced facial swelling that she described similarly to pitting edema that spanned acros... Read more
Patient experienced facial swelling that she described similarly to pitting edema that spanned across her forehead and temple area. The patient described it as not being red or typical of that of an allergic reaction. She did not experience this from her first shot in the series, and has never experienced these symptoms before.
46 2021-05-14 swelling face Five minutes after the injection my throat started to feel like it was closing, my lungs felt heavy ... Read more
Five minutes after the injection my throat started to feel like it was closing, my lungs felt heavy and it was difficult to breathe, my face swelled and I started feeling dizzy and lightheaded. I was admitted to the ER following the allergic reaction.
46 2021-05-17 lymph node pain, lymph node swelling Dizzy; Very swollen and very painful lymph nodes; Very swollen and very painful lymph nodes; Very na... Read more
Dizzy; Very swollen and very painful lymph nodes; Very swollen and very painful lymph nodes; Very nauseous; shaky; cold then hot; This is a spontaneous report from a contactable Other HCP (patient). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11Feb2021 15:15 (Lot Number: EN6201) (at the age of 46) as single dose for covid-19 immunisation. No other vaccine was received in four weeks. No covid prior vaccination, no covid tested post vaccination. No known allergies. Medical history included fibromyalgia, chronic fatigue syndrome, depression, anxiety, I have no spleen either. Concomitant medications included melatonin, duloxetine, bupropion. The patient experienced dizzy on 13Feb2021 03:00, very swollen and very painful lymph nodes on 13Feb2021 03:00, very swollen and very painful lymph nodes in armpit of arm that received the vaccine on 13Feb2021 03:00, very nauseous on 13Feb2021 03:00, shaky on 13Feb2021 03:00, cold then hot on 13Feb2021 03:00. The outcome was not recovered. No follow-up attempts are possible. No further information is expected
46 2021-05-17 lymph node swelling I had extreme feelings of weakness and lethargy after the second dose of the vaccine which dragged o... Read more
I had extreme feelings of weakness and lethargy after the second dose of the vaccine which dragged out for weeks. I did not feel shortness of breath, but I just felt very weak. I could not walk or exercise during that time. I had swelling in my lymph nodes. My Lymph nodes under my arm on the right were very swollen for quite a while. I fell down the stairs because my knees while I was so weak during that time. I felt that extreme fatigue for six weeks. It was two months before I felt normal, and I could walk and exercise.
46 2021-05-18 anaphylactic reaction anaphylactic reaction; I felt like I was dying; heart palpitations; stomach burning; warm sensations... Read more
anaphylactic reaction; I felt like I was dying; heart palpitations; stomach burning; warm sensations; her feet turned like a reddish color; fatigued; chills; felt out of sorts for a couple of days; her throat was a little sore; not feeling well; chest was just hurting; slight nausea; caller kept moving her arm in a circular motion to keep it from getting stiff; numbing tingling in my foot; numbing tingling in my foot; lost my voice; i was in bed for 1 week and 3 days; scary; a warm sensation in her stomach; felt out of sorts; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0170, first dose) solution for injection intramuscular in the left arm on 29Apr2021 at 17:15 (at the age of 46-years-old) as a single dose for COVID-19 vaccination. Medical history included fibroids (had to have 3 blood transfusions for this), severe allergy to fish and tomato, and chronic anemia (diagnosed with this after she had her children). Concomitant medication included diphenhydramine hydrochloride (BENADRYL) for very bad allergies. Family history included chronic anemia and Hashimoto's disease disorder (grandmother) in 2020. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Apr2021, the patient experienced anaphylactic reaction, heart palpitations, stomach burning, warm sensations, her feet turned like a reddish color, fatigued, chills, felt out of sorts for a couple of days, her throat was a little sore, not feeling well, chest was just hurting, slight nausea, kept moving her arm in a circular motion to keep it from getting stiff, numbing tingling in my foot, lost my voice, felt like I was dying, was in bed for 1 week and 3 days, scary, a warm sensation in her stomach, and felt out of sorts. The events did not require a visit to Emergency room or Physician's office. Unspecified treatment was provided for the event nausea. The outcome of the events heart palpitations, stomach burning, feet turned like a reddish color, throat was a little sore was recovered in 2021. The outcome of the events fatigued, chills, nausea was recovering. The outcome of the event warm sensation in her stomach was recovered on 29Apr2021. The outcome of the other events was unknown. No follow-up attempts are needed. No further information expected.
46 2021-05-18 lymph node swelling I?m not sure if it was a rash or hives that started on my left arm and spread all the way across my ... Read more
I?m not sure if it was a rash or hives that started on my left arm and spread all the way across my chest. The lymph node under my left arm was the size of a small golf ball for five days. I had a headache for 12 days.
46 2021-05-18 swelling face Facial swelling noted an hour and half after shot.; This is a spontaneous report from a contactable ... Read more
Facial swelling noted an hour and half after shot.; This is a spontaneous report from a contactable consumer (reporting herself). A 46 year old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E87534), via an unspecified route of administration in right arm on 20Mar2021 at 14:00 as a single dose for COVID-19 immunization. The patient did not receive other vaccine in four weeks of COVID vaccination. The patient not diagnosed with COVID prior vaccination. The patient did not tested for COVID post vaccination. The patient was allergic to seafood (shellfish), antibiotics. The patient's medical history were not reported. The concomitant medication included collagen and peptide.On 20Mar2021 at 15:30, the patient experienced facial swelling noted an hour and half after shot. The patient received Benadryl as the treatment medication for the event. The outcome of event was recovering. Follow-up attempts are required. Further information was expected.
46 2021-05-18 swelling face pt claimed had reaction from first dose two hours after receiving it. had lip swelling and facial s... Read more
pt claimed had reaction from first dose two hours after receiving it. had lip swelling and facial swelling but no shortness of breath per doctor's advise took Benadryl and had to take Benadryl for 4 days. She consulted yesterday with Doctor and got an ok to take the second dose and take Benadryl and Claritin before the shot. Referred case to supervisor and ok'd to give the shot. after 30 minutes of monitoring pt noted having lip swelling at 1455, gave her Benadryl IM and kept her for another 30 minutes. noted swelling subsided and felt better.
46 2021-05-18 swelling depressed thinking she; chest tighten; my heart raced; I couldn't breathe and had to remove my mask ... Read more
depressed thinking she; chest tighten; my heart raced; I couldn't breathe and had to remove my mask and try to deep breathe; I stood and felt dizzy, then sat and continued deep breathing; neck swelled at thyroid that night; my throat was itchy/sore; my throat was itchy/sore; headache; quite a few allergies; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8735) at the age of 46-years-old, via an unspecified route of administration in right arm on 01May2021 at 1st dose, single for COVID-19 immunization. Medical history included Ehlers Danlos, a connective tissue disorder. It is genetic but it also impacts one part of the immune system. The patient has not been diagnosed with this additional part because they did not think it was useful to go for a million tests for something that they have, then not going to treat them any differently. This goes with mast cell activation disorder and a lot of people with Ehlers Danlos have mast cell activation disorder. It causes a lot of allergic reactions to a lot of things. The patient then clarified that she has not been diagnosed with mast cell activation because it was not useful to go for a million tests. If the patient takes a medication, she gets an anaphylactic-like reaction. She has a lot of history with allergies to drugs. For family history, mast cell activation disorder, if people looked at concomitant conditions that go with mast cell activation disorder, her family history has every single one of those. This includes rheumatoid arthritis, Ehlers Danlos, bladder frequent urination issues, and they all have that. Also, multiple sclerosis. Also, gives like just getting hives. Her sister gets hives and reacts to the sun - she breaks out in hives. The list goes on with mast cell activation disorder and goes with Ehlers Danlos together with all of these big huge lists. Everyone in her family was represented on the whole list. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine, famotidine, cyanocobalamin (B12), ascorbic acid (C VITAMIN), colecalciferol (D3 VITAMIN), magnesium, and thiamine hydrochloride (B1 VITAMIN). She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has a lot of history with allergies to drugs and she has had reactions following previous vaccinations: in 2009, for the H1N1 pandemic, she got the vaccine for immunization and then she had Bell's Palsy. After that, she got an autoimmune disease which may or may not have been due to the vaccine. She did not remember what year it was she got the varicella vaccine for immunization and she experienced a racing heart and could not breathe, and she had to sit in the emergency room. A year ago (2020), she got the tetanus vaccine for immunization and had no reaction. She has had multiple other vaccinations too where nothing happened, and she has had lots of vaccines, so she was not scared of them. The facility where the most recent COVID-19 vaccine was administered was at a pharmacy or drug store. Since the vaccination, the patient has not been tested for COVID-19. On 01May2021 at 15:30 (also reported as within 30 seconds of receiving the dose), the patient felt her chest tighten, heart raced, and couldn't breathe; she had to remove her mask and tried to breathe deeply. When she stood up, she felt dizzy, then she sat and continued deep breathing. She mentioned that this scary part lasted for 5 minutes then diminished over the next half hour. She was offered antihistamine and they were ready with the epi-pen, but she didn't need it. She mentioned that on 01May2021, yer neck swelled at thyroid that night, and her throat was itchy/sore. The patient took two BENADRYL. She still has headache, but everything else mostly resolved. She had quite a few allergies after vaccination which was non-serious. Her sister had the same reaction and they have the same conditions. Her sister's reaction was different in that her sister's face swelled. The patient's reaction was that her heart raced, and she could not breathe. Both she and her sister were fine, but she did not think she could get the second vaccine unless she could get it in a more supervised state. The patient and her sister have Ehlers Danlos, which was a connective tissue disorder. It is genetic but it also impacts one part of the immune system. A lot of people with Ehlers Danlos have mast cell activation disorder. It causes a lot of allergic reactions to a lot of things. She was thinking if she could take a mast cell inhibitor, she could take the second vaccine dose to see if she does not have the reaction. She understood that they did not want people to do that, because they will have a diminished response. But, if it was between her not getting the second dose or maybe other people could get it and have lesser response and still get the second vaccine, it just seemed like something easy if Pfizer could just come up with a plan where she will get the second dose and see if she does not have that reaction. Yesterday, she was depressed thinking she could not get the second vaccine. The CDC said do not get the second dose if someone had a reaction. The patient mentioned that her heart rate was still a little weird the entire time. After five minutes, she thought okay maybe she will be fine. The first minutes or so, she thought maybe they will have to call 911 but it worked out. You never know with that allergic reaction stuff. She mentioned that her previous reaction with varicella vaccine was worse, the same thing as this was, but lasted longer than the COVID vaccine. She felt like the racing was longer and she could not breathe for a longer time, but it was similar. It was the live virus, she guessed she let it go because it was a live virus. She did not visit an emergency room of physician's office because she had these things happen to her before. Because she has experienced these things before, she did not get panicky and she just tried to breathe it out and see what happened. The kid that was attending her asked if she wanted him to call an ambulance and she said no, she was just going to wait and see if the breathing thing goes away and it did. Deep breathing helped it go away, she did not know why, but it just does. Her second dose was due for 22May2021. The outcome of the event "headache" was not recovered, recovered on May2021 for "neck swelled at thyroid that night", "my throat was itchy/sore", and "quite a few allergies", and recovered on 01May2021 for all other events.
46 2021-05-19 guillain-barre syndrome Consistent with Gullian-Barre. Limbs tingling and going numb, significant neck pain on injection sid... Read more
Consistent with Gullian-Barre. Limbs tingling and going numb, significant neck pain on injection side, arm pain continues from injection site, nausea, diarrhea.
46 2021-05-19 lymph node swelling Injection site pain; Lethargy; Headache; Sore throat; Muscle pain; Chills; Joint pain; Injection sit... Read more
Injection site pain; Lethargy; Headache; Sore throat; Muscle pain; Chills; Joint pain; Injection site swelling; it was hard but it was not red; Swollen lymph nodes; Severe abdominal pain; This is a spontaneous report from a contactable (Patient). A 46-years-old female patient received second dose bnt162b2 (BNT162B2, solution for injection, Lot Number: EL3302, expiry date was not reported), via an unspecified route of administration on 14Jan2021 as, SINGLE for covid-19 immunisation.The patient medical history was not reported. Concomitant medication(s) included Latuda, Synthroid taken for an unspecified indication. Patient previously took First dose of bnt162b2 (BNT162B2, solution for injection, Lot number EH9899 and expiry date was not reported), via an unspecified route of administration on 22Dec2020 as 1st dose single for covid-19 immunisation. The patient experienced injection site pain, lethargy, headache, sore throat, myalgia, chills, arthralgia, injection site swelling, lymphadenopathy, abdominal pain on 14Jan2021. Consumer who was a nurse Practitioner stated, "I wanted to report side effects for Pfizer-BioNTech COVID-19 Vaccine (later confirmed). I have injection site pain, lethargy, headache, sore throat, muscle pain, chill, joint pain, injection site swelling and it is so hard but it was not red and swollen lymph nodes and I felt feverish and then about 4 days later, I had severe abdominal pain but I do not know if that was related as she still had on and off abdominal pain, while everything else went away after about three days and when asked about expiration date of 1st dose consumer stated, "It does not say an expiration date here." Patient also informed that all the adverse events occurred after the second vaccination. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
46 2021-05-19 peripheral swelling caller states it has worsened.; swelling and pain near arm pit; swelling and pain near arm pit; This... Read more
caller states it has worsened.; swelling and pain near arm pit; swelling and pain near arm pit; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04May2021 11:29 (Batch/Lot Number: EW0153, vaccinated at the age of 46 years old) as single dose for covid-19 immunisation. The patient received the first dose on 13Apr2021. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced swelling near her arm pit, under the arm. It was pain and swelling and the patient thought it was near a duct or lymph node, but wasn't sure. The caller states that the patient had that vaccine on Tuesday and this is Thursday. Swelling started yesterday but he not sure on that. It is ongoing and that the caller states it has worsened. Outcome of events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available, the reported events of peripheral swelling and axillary pain and of the suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
46 2021-05-21 white blood cell count increased Approximately 40 minutes after getting my second dose of the Pfizer vaccine I developed severe abdom... Read more
Approximately 40 minutes after getting my second dose of the Pfizer vaccine I developed severe abdominal pain and chest tightness. I could not take in a deep breath and became diaphoretic with cold and hot sweats. My ring and pinky finger, both hands, became numb and were tingling with the numbness traveling down to my elbows. I became lethargic and had a feeling of extreme uneasiness followed by a bout of diarrhea. I then fell asleep for approximately 2 and half hours without moving. When i woke up the numbness was gone but I was still fatigued and had intense abdominal pain and still having the feeling that something wasn't quite right. I went to the ED the following day for the pain and general feeling of being unwell. At the ED I had high blood pressure, tachycardia, large amounts of blood in my urine and high WBC in addition to the above symptoms. For approximately two weeks after the initial onset of symptoms I still had abdominal pain and distention and extreme bloating.
46 2021-05-22 swelling Numbness on left side of face at 10 pm. Pain in the left arm staring from the site of injection to t... Read more
Numbness on left side of face at 10 pm. Pain in the left arm staring from the site of injection to the inner side of the left elbow. Difference in facial sensation between bilateral sides. Reported feeling swelling on left-side.
46 2021-05-23 peripheral swelling hyptertension and swelling in legs, hands, feet. 4-19-2021 to current. No treatment. Monitoring B... Read more
hyptertension and swelling in legs, hands, feet. 4-19-2021 to current. No treatment. Monitoring BP and swelling.
46 2021-05-25 swelling Beginning the next day, I started to experience an achy feeling in my upper arm, it traveled down to... Read more
Beginning the next day, I started to experience an achy feeling in my upper arm, it traveled down to my lower arm, then by the net day i felt the aching feeling in my wrist. It then went into my other right arm by 3 days post shot. Now all of my joints ache and are uncomfortable all the time (legs and arms). I am having issues picking up heavy items without pain. I feel like I am swollen in all of my joints. I otherwise feel great
46 2021-05-27 swelling face Burning eyes. Left eye worse than the right. Left face and eye swelling. Rash on face, neck. Random ... Read more
Burning eyes. Left eye worse than the right. Left face and eye swelling. Rash on face, neck. Random spots of rash on body
46 2021-05-27 swelling About 3 and a half hours later. I kept having trouble swallowing my saliva. I would have to try seve... Read more
About 3 and a half hours later. I kept having trouble swallowing my saliva. I would have to try several times each time to swallow. It felt as if my throat was swelling up.
46 2021-05-28 swollen extremities Transient b/l LE edema 2d after 2nd dose with neuropathy; Transient b/l LE edema 2d after 2nd dose w... Read more
Transient b/l LE edema 2d after 2nd dose with neuropathy; Transient b/l LE edema 2d after 2nd dose with neuropathy; This is a spontaneous report from a contactable physician. A 46-year-old non-pregnant female patient received (COVID 19 PFIZER), dose 2 intramuscular, administered in right arm on 13Apr2021 17:00 as single dose for COVID-19 immunization. Medical history included type 2 (DM) diabetes mellitus, obesity, vitamin D deficiency and was diagnosed with COVID-19 prior to vaccination; all from an unknown date and unknown if ongoing. The patient has no known allergies. The patient's concomitant medications were not reported. The patient previously received 1st dose of (COVID 19 PFIZER), intramuscular, administered in left arm on 23Mar2021 05:00 PM for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Apr2021, the patient experienced transient (bilateral) b/l lower extremities (LE) edema 2d after 2nd dose with neuropathy. Outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken were NSAID and muscle relaxant. Since the vaccination, the patient has not been tested for COVID-19.
46 2021-05-28 swelling face, lymph node pain, peripheral swelling I had a traveling itch right after injection, frequent, moving every 1 to 2 minutes it would move th... Read more
I had a traveling itch right after injection, frequent, moving every 1 to 2 minutes it would move through my body. I started to felt like swelling in my face and arms and body started getting red and my face got puffy. Within five hours I started to feel chills, body aches, feverish, and diarrhea. I had horrible brain fog, couldn't remember passwords. I had under arm swelling and pain in my lymph nodes, extreme fatigue.
46 2021-05-31 peripheral swelling, swelling Migraines, stiff neck, right arm pain, fatigue, muscle aches, swelling in my neck and shoulders
46 2021-06-01 lymph node swelling major swelling of lymph glands in neck jaw/continue to have minor swelling of one lymph gland on my ... Read more
major swelling of lymph glands in neck jaw/continue to have minor swelling of one lymph gland on my left clavicle; patient had a maximum temperature of 101; This is a spontaneous report from a contactable Other Healthcare Professional (nurse). A 46-years-old non-pregnant female patient reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER9231), via an intramuscular route of administration, administered in left arm on 06Jan2021 08:00 (at the time of 46-year-old) at single dose for COVID-19 immunization. The patient medical history included known allergies: shellfish. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medication within 2 weeks. Facility type vaccine was Hospital. Prior to vaccination, the patient had not Covid. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received the first dose of bnt162b2 (COVID-19), on an unspecified date for COVID-19 immunization. On 07Jan2021 07:00 after the second dose vaccination, the patient experienced major swelling of lymph glands in neck jaw/continue to have minor swelling of one lymph gland on my left clavicle patient had a maximum temperature of 101. It was reported that the first week patient had a maximum temperature of 101 and major swelling of lymph glands in neck jaw. Patient continue to have minor swelling of one lymph gland on my left clavicle 8 weeks post second vaccine. The patient underwent lab tests and procedures which included body temperature increased: 101 (the first week I had a max temp of 101) on 07Jan2021. The patient did not received any treatment for events. The outcome of events was resolved with sequel. No follow-up attempts are possible. No further information is expected.
46 2021-06-01 lymph node swelling Too much tiredness; lymphatic nodes were swollen (bean size, one was hard and the other one was bigg... Read more
Too much tiredness; lymphatic nodes were swollen (bean size, one was hard and the other one was bigger and softer) at the right lower side of the neck. They are still swelled today; This is a spontaneous report from a non-contactable Health care professional. A 46-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date: was not reported) via intramuscular, administered in right arm on 26Jan2021 at 12:15 as 2ND single dose for COVID-19 immunization. The patient medical history included penicillin drug allergies. The patient concomitant medications were not reported. Historical vaccine includes patient received, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 intramuscular, administered in right arm on 05Jan2021 at 02.30 as 1st dose, single dose for COVID-19 immunization. Patient did not received any other vaccine in four weeks and no other medication in two weeks. Patient had no COVID-19 prior vaccination. Patient had not tested for COVID-19 post vaccination. The patient experienced the night of vaccination too much tiredness. on thursday (2 days after), 2 lymphatic nodes were swollen (bean size, one was hard and the other one was bigger and softer) at the right lower side of the neck. they are still swelled today at 06.00AM on 28Jan2021. The event was not treated. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-06-02 axillary mass, lymph node swelling lymph node swelling; What ingredient might cause a magnet to stick to the place where she got the va... Read more
lymph node swelling; What ingredient might cause a magnet to stick to the place where she got the vaccine?; achy and tired like she was getting the flu; achy and tired like she was getting the flu; achy and tired like she was getting the flu; Huge lump in armpit; Discomfort in clavicle; This is a spontaneous report from a contactable consumer (patient herself). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration in Arm Left on 05Feb2021 (at the age of 46-year-old) as 2nd dose, single dose for covid-19 immunization. The patient previously received first dose of bnt162b2 (Lot number: EL3248, Expiry Date: Unknown) administered in Arm Left on 14Jan2021 as single dose for covid-19 immunization. Medical history included high cholesterol and caller has been diagnosed for a long, long time. It was hereditary. If she has to guess, it has been at least 12 years and hypothyroid has been diagnosed for maybe about a year. Family Medical History reported as none. The patient's concomitant medications were not reported. Consumer states that she had just takes her regular medications. Additional Vaccines administered on same date with the Pfizer vaccine considered as suspect reported as none. The prior vaccinations of the patient was reported as None. On an unspecified date, the patient experienced lymph node swelling, magnet sticks to the place she got the shot, achy and tired like she was getting the flu, huge lump in armpit and discomfort in clavicle. Consumer stated that she had both doses of the vaccine and she had lymph node swelling. She was discussed how a magnet sticks to her injection site, at which time she mentioned that this happened to other people. She would like to know what ingredient might be in the vaccine that would cause a magnet to stick to the place she got the shot. Caller adds she would have had no idea about it, she had no symptoms except where she put a magnet where they put her shot. It is in her clavicle in the armpit, left side, and that is the side she got the shot. It popped up within 36 hours after she got her vaccine on 05FEB2021. Caller states she is not a healthcare provider but that she works for a hospital, and later confirms that she is not a healthcare provider like a nurse, pharmacist, or physician. Caller states she reported this to her doctor right away when she had lymph node swelling, and her doctor sent her for ultrasound of clavicle. It came back negative for anything odd but she has lymph nodes on top of her clavicle that were not there prior. She has a golf ball size lump in her left armpit. She did read that was a possible normal reaction. She waited quite a while. Caller adds she got the vaccine around 1 o clock in the afternoon and that was 05FEB2021, her second one. She started not feeling well around the afternoon next day. She actually stopped working. She was achy and tired like she was getting the flu, but it went away quickly. Later that day, it was probably it might have been the next morning when she showered, she had a huge lump in her armpit. It was so uncomfortable in 24 hours period, it could have been swollen and she just did not know. Caller adds it was where she wears a seatbelt and stuff, where that was not there before. One thing was she did have over 30 years ago, she broke her collar bone and she never had this feeling before or lymph nodes on top of it. Achy and tired like she was getting the flu, this went away as fast as it came, maybe 12 to less than 24 hours. Caller adds that with cholesterol, it was doing good and she did go off medications for a while and she did not think she was on the medication when she got the vaccine. She went to the physician office two days after the vaccine to tell the doctor about the swelling, and they went from there. Caller adds since they heard about the swelling, they were waiting for it to go away before they did tests. The patient underwent lab tests and procedures which included mammogram: normal and ultrasound scan: normal on 19May2021: clearly a lump there, ultrasound scan: normal on 27Apr2021: lymph nodes on top of her clavicle. The treatment was reported as none. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
46 2021-06-07 lymph node swelling Swollen lymph node near collar bone, left side. With intermittent shooting pain for about a week
46 2021-06-07 swelling face Swollen face; severe itchiness; tiredness; dull headache; This is a spontaneous report received from... Read more
Swollen face; severe itchiness; tiredness; dull headache; This is a spontaneous report received from a non-contactable consumer(patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Lot number: EN6207, expiry date: not reported) via an unspecified route of administration at UNKNOWN SINGLE DOSE on 11Mar2021 for COVID-19 immunisation. Medical history included breast cancer. The patient was allergic to poultry. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication was not reported. The patient previously took tamoxifen and had allergic reaction to drug. On 11Mar2021, the patient experienced swollen face, severe itchiness, tiredness and dull headache which were still lasting even after 6 days (as reported). On an unspecified date, post the vaccination, the patient underwent a nasal swab test and the result was unknown. The patient did not receive any treatment for the events. The clinical outcome for the events swollen face, severe itchiness, tiredness and dull headache was reported as not recovered at the time of this report. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Patient's first name added in patient tab, Patient's age/unit added in patient tab, duplicate reported indication of BNT162B2 removed, treatment received ticked as No, Concomitant therapy left blank since no information provided about the concomitant drug.
46 2021-06-08 peripheral swelling, swelling, swelling face When I received my vaccine, I waited 15 minutes at pharmacy and didn't notice any adverse symptoms. ... Read more
When I received my vaccine, I waited 15 minutes at pharmacy and didn't notice any adverse symptoms. But around 4:00 pm, I stood up and noticed that my knees were swollen, popping and cracking when I walked. I have never had any problems with my knees, and exercise regularly, so at first I thought is was just a weird Covid side affect...but I couldn't find that particular symptom on the list of Covid vaccine side effects. I took 2 Alleve and applied Arnica Gel to my knees. A couple hours later, my fingers, hands and wrists felt swollen. Then overnight, I noticed that I started to feel itchy, tingly in random spots all over my body. But I did not develop a rash. The next morning, my face was swollen, my throat felt sore/tight, everything felt puffy and swollen. My daughter asked me if I got Botox because "my wrinkles were gone"!! That's when I knew it was an allergic reaction. I took 2 Benedryls and just napped all day. I continued taking Benedryl for 2 days, and eventually the symptoms went away. Other than swelling, I only had mild muscle pain at the injection site. No fever or muscle pain, just swelling and the tingly itchiness all over. However, the joint discomfort in my knees and hands is still there.
46 2021-06-08 peripheral swelling Swollen arm, pain, itching.
46 2021-06-08 swelling her left leg where she had the hives and rash; bumps; pimples; Itchy all over her body; her right si... Read more
her left leg where she had the hives and rash; bumps; pimples; Itchy all over her body; her right side was painful from her shoulder, back, and scapula area on the right side all the way to her arm; her right side was painful from her shoulder, back, and scapula area on the right side all the way to her arm; her right side was painful from her shoulder, back, and scapula area on the right side all the way to her arm; Started breaking out in hives on one leg only; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Expiration Date: unknown), via an unspecified route of administration, administered in arm left on 24May2021 at 13:00 (Batch/Loat Number: EW0187) as 1st dose, single dose for covid-19 immunization.Medical history included asthma (she had asthma as a child).Concomitant medication included cortisone taken for an unspecified indication.The patient did not receive any other vaccines prior to the COVID vaccine. The patient didn't had adverse event prior vaccinations.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25May2021 (Tuesday )morning at around 20:00 to 21:00, the patient started feeling itchy all over her body and at around 22:00 she started breaking out in hives on one leg only. It was only in one spot and Tuesday evening her whole leg had over 10 hives. On 26May2021, the next day the patient did not know if it was because of her itching, but the hives turned bumpy. She still has the marks there. It has been a week now. It was very itchy, she went to the doctor this weekend and had bloodwork, and she was waiting on the results. She was not sure if she was able to take the second vaccine. She got the vaccine in her left arm and had a reaction on her left leg. Also, that Tuesday morning, her right side was painful from her shoulder, back, and scapula area on the right side all the way to her arm. It is not when she moves it, it was just painful for a couple of days there. The hives and bumps are starting to go away, but she is still very itchy. She took Cortisone, Benadryl, and Claritin. The Benadryl she got off the shelf, and the Cortisone and Claritin were prescribed. She has no NDC, lot, or expiration date available for the Cortisone, Benadryl, or Claritin that she took. It was only on the left side that she broke out with hives and pimples. Her body and skin feel itchy all over, but it was only her left leg where she had the hives and rash. The hives and bumpy rash are starting to go away. She can tell it was starting to go away. Her right arm was painful all the way from her shoulder and upper back to her arm. It was not painful when she moved it, it was more just pain. It got better, Tylenol helped. She would say it lasted 2 or 3 days then it subsided. The patient took the vaccine because of her kids were pressuring her. She didn't want to get it, but it was family pressure. The patient was not hospitalized. The patient was visited physician office. Patient lab test included: She was tested for allergies and had a CBC on 29May2021 (Saturday) results were not back yet. The outcome of the event itchy all over her body was not resolved, the outcome of the events started breaking out in hives on one leg only, hives on leg turned bumpy, bumps were resolving, outcome of the event her right side was painful from her shoulder, back, and scapula area on the right side all the way to her arm resolved in May2021 and the outcome of the event her left leg where she had the hives, rash and pimples were unknown. Information on the lot/ batch number has been requested.
46 2021-06-09 guillain-barre syndrome Guillain Barre Syndrome (tingling, heat, sharp electrical-like pains started in both feet in the mor... Read more
Guillain Barre Syndrome (tingling, heat, sharp electrical-like pains started in both feet in the morning); Pains eventually attacked my lower stomach; This a spontaneous report from a contactable consumer (patient herself). This 46-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0173), via an unknown route of administration in the left arm, on 08May2021 09:30 AM (at the age of 46-year-old female) at single dose for COVID-19 immunisation, administered at Pharmacy/drug store. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0153), via an unknown route in the left arm, on 17Apr2021 09:30 AM (at the age of 46-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. The patient did not have relevant medical history and concomitant medications. On 13May2021 07:00 AM, she had tingling, heat, and sharp electrical-like pains started in both feet. By afternoon it had traveled up both legs. It eventually attacked both legs and her lower stomach. The patient visited the emergency room (ER) where doctor diagnosed Guillain Barre Syndrome. The patient was treated with gabapentin and pain meds. In May2021, computerized tomogram (CT) scans and lumbar puncture were done but results were not provided. The patient is currently recovering from the events.
46 2021-06-09 lymph node swelling upper back pain; neck pain; Thirsty; hungry; Nausea and feeling of vomit; Wrist /Hip/ joint pain; Sw... Read more
upper back pain; neck pain; Thirsty; hungry; Nausea and feeling of vomit; Wrist /Hip/ joint pain; Swollen throat; Left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) as single dose via an unspecified route of administration on left arm on 11Mar2021 at 18:30 (at the age of 46-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that none other medications received by the patient within 2 weeks of vaccination. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to and since vaccination, the patient was not been diagnosed with COVID-19. On 11Mar2021 at 20:30, the patient experienced hungry, nausea and feeling of vomit, neck pain, swollen throat, thirsty, upper back pain, wrist /hip/ joint pain and also reported left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin. The patient says no fever and it was a week after 1st dose and symptoms still existed and she felt like she was overdosed. The patient visited Doctor or other healthcare professional office/clinic and she reported the same to physician and waiting for response. Therapeutic measures taken was unknown. The clinical outcome of events hungry, nausea and feeling of vomit, neck pain, swollen throat, thirsty, upper back pain, wrist /hip/ joint pain, left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin were not recovered. No follow-up attempts are needed. No further information is expected.
46 2021-06-10 axillary mass knot in left armpit, mucus drainage, sneezing, 2 weeks, fatigue, headaches, chest pains,
46 2021-06-10 swelling, peripheral swelling Meningitis type symptoms; Severe swelling on right side neck, shoulders, arms; Severe swelling on ri... Read more
Meningitis type symptoms; Severe swelling on right side neck, shoulders, arms; Severe swelling on right side neck, shoulders, arms; Severe swelling on right side neck, shoulders, arms; Four episodes of migraines; Vomiting with Migraines; Rash on right side; Tired; Flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0168 and expiration date was not reported), via an unspecified route of administration, administered in arm right on 11May2021 (at the age of 46 years old) as single dose for covid-19 immunization. The patient medical history and family medical history relevant to adverse events was none and concomitant medications were not reported. Previously, patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number: ER8735 and expiration date was not reported), via an unspecified route of administration, administered in arm right on 20Apr2021 15.35 as single dose for covid-19 immunization at Pharmacy. The patient had no adverse events following prior vaccinations. No prior vaccinations (within 4 weeks) and no additional vaccines administered on same date of the Pfizer Suspect. No other products were given. On 12May2021, the patient had flu like symptoms. On 13May2021, the patient was tired. On 14May2021, the patient had rash on right side. On 16May2021, the patient had severe swelling on right side neck, shoulders, arms. The patient had a total of four episodes of migraines with vomiting since the first one on 16May2021. The patient stated that the migraines and vomiting were persisting; but mentioned that she had not had an occurrence since 30May2021 (this past Sunday). She wanted to make sure it was notated in the report that she had an appointment with an Immunologist on 08Jun2021 (Tuesday) and with a neurologist on 16Jun2021. The patient had a severe adverse reaction that resulted in two emergency room and one urgent care visits. One of the doctors reported it to her about local Department of Health and Environmental Control (DHEC); they called her and said she needed to call and report it to Pfizer. Emergency room and physician office visit was done for severe swelling on right side neck, shoulders, arms; migraine; vomiting with migraines. On unspecified dates, the patient had for meningitis type symptoms. The patient denied any medications or medical conditions relevant to events. The patient underwent lab tests and procedures which included Computerized tomogram (CT) scan with result as nothing abnormal, no blood clots on unspecified date. The outcome for meningitis type symptoms was unknown, for severe swelling on right side neck was not recovered, for severe swelling on shoulders was not recovered, for severe swelling on was not recovered, for rash on right side was recovering, for migraine was not recovered, for vomiting with migraines was not recovered, for flu like symptoms was recovered on 13May2021, for tired was recovered on 15May2021. Follow-up attempts are completed. No further information is expected.
46 2021-06-11 peripheral swelling I received a rash; I have mouth sores; I have swelling in my legs; I was tired; Headache; This is a ... Read more
I received a rash; I have mouth sores; I have swelling in my legs; I was tired; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient (non-pregnant) received BNT162B2, first dose via an unspecified route of administration at left arm on 06Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at age of 46-year-old (non-pregnant). The patient medical history included covid prior vaccination. Concomitant drugs were not reported. The patient had Rash, Mouth sores, swelling in her legs, was tired and headache on 10Apr2021. The events resulted to visit doctors or other Healthcare professional office/ Clinic visit, Emergency room, department or Urgent care and hospitalization for 2 days. The patient received creams as treatment for rash. The patient had Covid test on 27May2021 and Covid test result was negative. Outcome of the events was not recovered. The patient received second dose of bnt162b2 on 26Apr2021 at left arm later. Information on the lot/batch number has been requested.
46 2021-06-11 swelling Within 2 hours of receiving Pfizer shot, I got heart palpitations, shortness of breath, inflammation... Read more
Within 2 hours of receiving Pfizer shot, I got heart palpitations, shortness of breath, inflammation, joint pain and swelling, back aches. Shortness of breath continues and has impacted normal life and normal daily activity. Walking up the stairs causes shortness of breath, doing light chores around the house causes shortness of breath like vacuuming, cleaning the bathroom, carrying a load of laundry causes shortness of breath, etc.
46 2021-06-12 lymph node swelling Approximately forty-five minutes after the second vaccine dose, I began wheezing. I have a history o... Read more
Approximately forty-five minutes after the second vaccine dose, I began wheezing. I have a history of asthma as well as medication allergies. This was deep wheezing that happens when I have an allergic reaction. In spite of using my albuterol inhaler, I continued to wheeze (moderate) throughout the night. I stayed up most of the night to monitor myself, using my inhaler every four hours. I am in a densely populated area with a lot of hospitals, so I knew I could call for an ambulance if needed and therefore chose not to go immediately. I take a daily dose of an antihistamine (Allegra 180mg). The following morning, I woke to increased wheezing. I took my antihistamine a few hours early, and within an hour, the wheezing was better, and within a couple of hours, it had decreased to the level it had been the day prior. By late that night, I was no longer wheezing. In addition to wheezing, I got a mild headache almost immediately after the second vaccine dose was given. After the first dose, I experienced a bitter taste in my mouth. I had recently been on clindamycin, which caused a very bitter/metallic taste in my mouth. I was finished with the antibiotic 8 days before the first dose of the vaccine. I wasn't sure that the bitter taste was related to the Pfizer vaccine, but the taste had started to decrease pretty significantly in the two days before the second dose. Within a few hours after the second Pfizer dose, the bitter taste had returned to the level it was after the first dose. I still have the bitter/metallic taste in my mouth as of today (06/13/2021). I believe the other symptoms I had were normal post-vaccine side effects (malaise, aches, swollen lymph nodes, low-grade fever, additional headaches).
46 2021-06-12 peripheral swelling Left arm pain and swelling for 3 days. Started to have shortness of breath, mild wheezing for few mi... Read more
Left arm pain and swelling for 3 days. Started to have shortness of breath, mild wheezing for few mins then subsides. The shortness of breath and mild wheezing occurring few mins once or twice a day occurred 3-5 times since getting the Pfizer vaccine.
46 2021-06-13 anaphylactic reaction Anaphylactic Reaction, Epi-Pen, Albuterol given. Transported by Ambulance to ER, given Benadryl, Pe... Read more
Anaphylactic Reaction, Epi-Pen, Albuterol given. Transported by Ambulance to ER, given Benadryl, Pepcid, Prednisone. Prescribed Benadryl, and Prednisone. Released from ER 5 hrs after onset of Allergic Reaction. Reaction began around 10:35 am, released from ER around 3:30pm - 3:50pm
46 2021-06-13 lymph node swelling 11 Hours after injection had 102 degree fever and chills, Slightly sore arm, swollen lymph nodes in ... Read more
11 Hours after injection had 102 degree fever and chills, Slightly sore arm, swollen lymph nodes in left armpit and left side of neck for 3 days. Swollen lymph nodes near left collar bone for 5 weeks. It was the size of a large pea. Developed an asthmatic cough and allergies heightened with nasal drip and itchy eyes.
46 2021-06-14 lymph node pain Right leg and right foot have been numb for one week. Arms are numb sometimes but not continuously. ... Read more
Right leg and right foot have been numb for one week. Arms are numb sometimes but not continuously. Sore arm. Sore belly. Right ear hurts inside. Lymph nodes on neck hurt. Headaches.
46 2021-06-15 peripheral swelling Unusual, large swelling in both feet and lower legs within 3 hours of vaccination. Swelling was so i... Read more
Unusual, large swelling in both feet and lower legs within 3 hours of vaccination. Swelling was so intense in feet it bordered on painful.; Swelling was so intense in feet it bordered on painful.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 12Mar2021 19:30 (Lot Number: En6208) (at the age of 46-years-old) as 1st dose, single dose for covid-19 immunization. Medical history included hyperlipidaemia, high triglycerides, obesity, asthma and atopic dermatitis all from an unknown date and unknown if ongoing. The patient had known allergies for shellfish and latex. The patient did not receive other vaccines in four weeks. Concomitant medications included omega-3-acid ethyl ester (LOVAZA), rosuvastatin calcium (CRESTOR), vitamin d NOS and levocetirizine dihydrochloride (XYZAL), all taken for an unspecified indication, start and stop date were not reported. The patient experienced unusual, large swelling in both feet and lower legs within 3 hours of vaccination on 12Mar2021 at 22:30. Swelling was so intense in feet it bordered on painful. The patient had no Covid prior to vaccination and had not been tested for COVID post vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected
46 2021-06-16 lymph node swelling limpnode Swollen under arm
46 2021-06-16 peripheral swelling After receiving the vaccine, around 6 minutes later the patient stated she noticed that her left arm... Read more
After receiving the vaccine, around 6 minutes later the patient stated she noticed that her left arm below her elbow was puffy/swolen. I continued to observe the patient for 30 minutes. It never got any bigger, wasn't warm to the touch. I asked the patient if she had any difficulty breathing, or tinging, no swelling of lips or tongue. I informed the patient to take benadryl. pt left with her husband
46 2021-06-16 peripheral swelling About 2-3 days after my second COVID-19 Pfizer vaccine shot, the middle finger of my right had began... Read more
About 2-3 days after my second COVID-19 Pfizer vaccine shot, the middle finger of my right had began to swell, turn slightly purple, and become painful, and this pain and swelling worsened as the week progressed. I also experienced unusual redness and itching on both my hands, especially the palms and writsts, but this has been only mild, and occasional. The pain in my fingers, however, seems to wax and wane, sometimes spreading to my pointer finger and most of my third finger, and other times receding just to the top inch or two of my middle finger. Everything I do with my hand--write, type, wash, etc.--has been hampered by the pain and swelling, and the discomfort has occasionally kept me awake at night. It has now been about a week since this symptom became noticeable. It is slightly less painful than it was in the first 2-3 after the onset of symptoms, and the swelling is mainly restricted to the top inch of my middle finger (approximately up to the first joint) but it is still painful enough to hamper my everyday life. I hope and pray sincerely that it will resolve soon.
46 2021-06-19 fluid retention High blood pressure spiking ~165/120 Water retention Agitation 48 hours later started an inflammat... Read more
High blood pressure spiking ~165/120 Water retention Agitation 48 hours later started an inflammatory nightmare headache, full debilitating body pain, diarrhea for days followed by several days of constipation ?. This has ignited an inflammatory firestorm for me given the MCAS and I?m still struggling to get things back in order and leveled off
46 2021-06-19 swelling Developed neck swelling, and pain with difficulty swallowing to solids and liquids including saliva.... Read more
Developed neck swelling, and pain with difficulty swallowing to solids and liquids including saliva. The symptoms began the day after the shot and became worse each day. On the third day after the shot I was very uncomfortable and called the on call physician for my doctor. I was already taking acetaminophen for my symptoms. He recommended adding an antihistamine. I started Zyrtec once daily with a mild transient improvement in my symptoms. Today is day 4 after the shot and I am still very uncomfortable, with neck swelling and difficulty swallowing. On day 2 after the shot I woke up with tinnitus in both ears that has been constant since it began, especially prominent in the morning and most noticeable in quieter surroundings but constantly there in the background. In addition I experienced fatigue, headaches and malaise on days one, two and three after the shot. Those symptoms have resolved by day four.
46 2021-06-20 lymph node pain, lymph node swelling I received my first dose of Pfizer covid vaccine in my right deltoid on Friday June 18 at 12:00 pm. ... Read more
I received my first dose of Pfizer covid vaccine in my right deltoid on Friday June 18 at 12:00 pm. I had no reactions until 9:00pm that night. I Had significant joint pain and stiffness in all my major joints and at the injection site. By midnight I had severe nausea and vomiting and low grade fever. All day Saturday I had joint pain and stiffness, temp of 100.2 and fatigue. When I woke up Sunday morning I had a swollen lymph node in the right side of my neck about the size of a golf ball as well as swollen lymph nodes under my right arm about the size of a golf ball. The lymph node swelling and tenderness is still present currently.
46 2021-06-22 lymph node swelling Swollen Lymph node under left clavicle.
46 2021-06-23 swelling face, swelling I had an adverse reaction (swelling) about 4 hours after getting the first Vaccine shot. I explaine... Read more
I had an adverse reaction (swelling) about 4 hours after getting the first Vaccine shot. I explained this to the pharmacist when I went back for my second dose, and he gave me 2 Benedryl pils before giving me the second dose of the vaccine. This time I had immediate swelling, and felt it in my face and lips, slightly itchy. Then I felt the Benedryl kick in, and about 2 hours later I felt better. Still had serious joint swelling, especially in my knees (sane as with first dose). But I took photos of my face this time and you can clearly see my face was puffy and swollen immediately after getting the vaccine. With the first dose, the facial swelling started much later, 4-6 hours later. I took another photo about 2 hours later and the swelling was gone. Clearly I am allergic to something in this vaccine, and the Benedryl definitely worked but I wouldn?t choose to get another shot since the reaction was so immediate.
46 2021-06-24 peripheral swelling All 5 of us have ongoing pathogen, some with severe SOB ongoing loss of taste and smell. and had som... Read more
All 5 of us have ongoing pathogen, some with severe SOB ongoing loss of taste and smell. and had some symptoms on covid of flu dose #1; loss of smell; fatigue; all symptoms of covid returned; Nausea; vomiting; diarrhea; COVID-induced POTS, no suspected; Hypercholesterolemia; paralysis; All 5 of us have ongoing pathogen, some with severe SOB ongoing loss of taste and smell/increasing SOB; Headache; upper respiratory symptom; chest pain; tightness; leg swelling; dizziness; extremity shaking; This is a spontaneous report from a contactable consumer. A 46-years-old female patient received First dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9261),via intramuscular on 05Feb2021 10:20 (at the age of 46 years old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included Shingles 2x in Mar2016 & again 2017 after vaccine ,ongoing Treatment include Lyrica via oral route from 2016 ,Mono-epstein barr from unspecified date in Feb2020 to unspecified date in Aug2020 and covid-19 on 29Oct2020.Concomitant medications include Ibuprofen 800mg 3x/day for EVLT From Oct2019 to Apr2021,Progesterone from unknown date ,unknown if ongoing .Historical vaccine include Flu 10/20 Shoot before Covid on unspecified date in Oct2020. It was stated that father contracted covid for first time Dx on 10Mar2021. All his four children contracted it felty from his sibling brother. All five of us those ongoing fatigue, some with severe S.B, ongoing loss of taste & smell. All had same symptoms of covid after dose one. One sibling is resistant to vaccine based upon our reactions to vaccine. On 05Feb2021 After the vaccination of first dose the patient experienced Headache, upper respiratory, then increasing SOB(medically Significant), chest pain, tightness, then leg swelling, then onset of new symptoms of dizziness, paralysis(disability/medically Significant) and extremity shaking. On 17Feb2021, the patient experienced nausea and vomiting. Very sudden onset symptoms to 15Feb2021 but had to go to ER as SOB, had a PE after vaccine, had nature of covid but had all resolved after 1st dose. Will continue, no SOB, very little figure, 98%-99%c resolved. After shoot on 15Feb2021, had sudden diarrhea/SOB ponanysis. After taking a at school on 15Feb2021, ER after sudden onset, held the POTS, covid-induced POTS, no suspected. MCAS at 8 AM, excreted (adblosus disease. Hypercholesterolemia). Also, led to know after secure. We Appetited many food since vaccine. Seriousness criteria important medical event include hospitalization/prolongation of hosp, persistent/significant disability/incapacity. AE required visit to emergency room. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 16Jun2020, sars-cov-2 test positive on 29Oct2020, computerised tomogram pe ruled out on 17Feb2021, electrocardiogram stroke ruled out on 19Feb2021 and magnetic resonance imaging stroke ruled out on 19Feb2021. Treatment was received for events. Outcome of the events All 5 of us have ongoing pathogen, some with severe SOB ongoing loss of taste and smell. and had some symptoms on covid of flu dose 1, loss of smell, diarrhea, covid-induced POTS, no suspected, hypercholesterolemia and all symptoms of covid returned was unknown. Outcome of the other events was recovering.
46 2021-06-25 pancreatitis fevers; pain in back; Diagnosed with pancreatitis/abdominal pain/She thought it was muscle pain; ach... Read more
fevers; pain in back; Diagnosed with pancreatitis/abdominal pain/She thought it was muscle pain; aches/She had the aches partially on Wednesday; chills; This is a spontaneous report from a contactable consumer (patient's husband). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm on 07Jun2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included she was not on medications or anything else. She had no medical conditions. She was otherwise healthy and she did not have any issues apart from knee surgery here and things you get when moving through age, nothing abnormal or noticeable. She does not drink. Historical vaccine included 1st dose of BNT162B2 for COVID-19 immunisation. Prior Vaccinations (within 4 weeks) If applicable, other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. The patient's concomitant medications were not reported. She went and got the second vaccine on Monday (07Jun2021) and had chills, aches, and all of those things that were associated with it. She also had abdominal pain that came on as well. She thought it was muscle pain. Caller stated this was on Tuesday night (08Jun2021), and then Wednesday night she went to the ER. She was now diagnosed with pancreatitis. Chills and aches: she got the shot and it started around 6 o'clock at night or 5 o'clock at night, somewhere around there which was about 6 hours afterwards. After the second vaccine shot. It was Monday 07Jun2021 she received it. Caller adds she was in the hospital right now. Chills and aches, abdominal pain, pain in back, fever: they went away probably in the middle of the night between 08Jun2021 and 09Jun2021. So, she got the shot on 07JUN2021 around 6 o'clock and chills and aches through Tuesday. She had the aches partially on Wednesday 09Jun2021. At the end of the day, she felt better with the fever and aches but her pain was excruciating in the abdomen and back. Caller clarified this all started at the same time. She thoughts it was muscle pain and not anything else going on. Caller adds the abdominal pain was still going on. It was subsiding because they were kind of getting it under control but she was in a lot of pain right now. She was admitted yesterday morning (09Jun2021) around 3 or 4 o'clock, it was early, maybe 5 o'clock. Diagnosed with pancreatitis: it was the day she went in, was yesterday (09Jun2021). Investigations: she had lab blood work, ultrasound, MRI. Treatment, Investigations: caller stated pancreatitis does not have treatment besides managing the pain, the MRI and the ultrasound revealed no blockages or masses or cysts of organs, and no apparent cause of the pancreatitis. Outcome of the events was unknown. Information for lot number has been requested.
46 2021-06-27 swelling Left carotid artery swollen and painful
46 2021-06-28 lymph node pain Painful L supraclavicular lymph node
46 2021-06-29 lymph node swelling 1st shot - Arm was numb and tingly. Patient thought a nerve was pinched. 2nd shot - 2 day after pai... Read more
1st shot - Arm was numb and tingly. Patient thought a nerve was pinched. 2nd shot - 2 day after pain in arm worsened (numb, tingling, throbbing and twitching - very painful), flu-like symptoms (chills, fatigue, dizziness etc.), Fainted and was injured during the fall (took 2 sick days off of work). Cheeks were sore possible immune system over reacting and attaching juvaderm filler in cheeks. Week 2 - developed a head-cold to a sinus infection symptoms: swollen glands, mucous and coughing up phlegm, still fatigued, arm is still numb and tingling but lesser so. Reported reaction to Dr. on 6/30/21.
46 2021-06-29 swelling face eyes swollen; her mouth was swollen; face swelled; allergic reaction; rash on her neck, Body rash; b... Read more
eyes swollen; her mouth was swollen; face swelled; allergic reaction; rash on her neck, Body rash; bad immune response; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 46-year-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9267; Expiration Date: May2021), via an unspecified route of administration on 13Feb2021 at between 10:00am to 10:30am (age at vaccination: 46-year-old) as single dose for covid-19 immunization. The patient's medical history included non alcoholic liver disease (2017- ongoing), asthma (Unknown-ongoing), Hashimoto's disease (2002- ongoing). food allergies to a lot of raw veggies and raw fruits diagnosed in 2014 and is allergic to almonds and hazelnuts. The patient's concomitant medications were not reported. On an unspecified date, around three weeks before her first dose of bnt162b2, the patient had an unspecified allergy shot. The patient further stated that she gets four of them (allergy shots) for grass and trees, dust mites, pet dander, and the fourth is for tree pollen. On 25Jan2021, the patient took first dose of bnt162b2 (lot EL9262) on 25Jan2021 for covid-19 immunization. After receiving her second dose of BNT162B2 on 13Feb2021, around 60 hours later, on the night of 15Feb2021, the patient had allergic reaction of body rash and the patient went to HCP office. The patient stated that the rash was ongoing and worse. On 19Feb2021, the patient's face swelled. The patient further stated that the face "swells and then if she eats something it sets it off but right now her face is not swollen." On an unknown date in Feb2021, the patient's body rashes were all over and she had a lot of bad immune response to the Pfizer Vaccine and has been to urgent care on 20Feb2021, exactly 1 week after the 2nd dose of the vaccine because her face swelled up. she sought urgent care 6 days after because her mouth was swollen after eating popcorn which she was not sure if it is because of the vaccine or the popcorn. HCP prescribed Prednisone for her for 10 days and the first round of the Prednisone for her face swelling was given to her on 20Feb2021 at urgent care and it was 60mg for four days then the HCP tapered it to 40mg for three days then 20mg for three days for 10 days total. The patient was on Prednisone for those days then the body rash took four days before it went away. A few days after the Prednisone she thinks 2-3 days later the first dose of Prednisone (on an unknown date in Feb2021), the body rash started to come back. The patient restarted Prednisone for a second round on an unknown date, and called the allergist too and thought it was something she ate maybe causing her this trouble and she did not put this with the Pfizer vaccine but she read that the severe allergic reaction would occur right after the Pfizer Vaccine and her reaction was not right after the vaccine. The patient was eating normal foods and had the rash on her neck here and there , took a Benadryl one day then the rash would go away; The patient took one tablet of Benadryl which was 25mg. On 14Mar2021 morning , the patient woke up with a swollen face again with lips, eyes swollen and had a rash on the upper part of her body. The patient's HCP thought that its (the events) were due to the Pfizer vaccine. The patient thought that her body does not like the vaccine because when she eats things she is not reacting well and gets her rashes. Therapeutic measures were taken as a result of events. Outcome for the events was reported as unknown.
46 2021-07-02 swelling face Face swelling. Starting eyelid/around eyes most obvious.; Face swelling. Starting eyelid/around eyes... Read more
Face swelling. Starting eyelid/around eyes most obvious.; Face swelling. Starting eyelid/around eyes most obvious.; Face swelling. Starting eyelid/around eyes most obvious.; Whole face itchy/burning sensation; Whole face itchy/burning sensation; This is a spontaneous report from a consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3247) via an unspecified route of administration in the left arm on 04Mar2021 at 13:15(at the age of 46-year-old) as single dose for COVID 19 immunisation. The patient medical history included swelling face on unknown date in Jul2020 and Aug2020. The patient did not take any concomitant medication. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. Any allergies to medications, food, or other products was reported as shellfish and cats. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. On 07Mar2021at 19:00, the patient experienced swelling face, starting eyelid and around eyes most obvious, Whole face itchy and burning sensation. Therapeutic measures were taken as a result of the reported events and included treatment with antihistamine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care however the patient contacted her Doctor with pictures via email. The clinical outcome of the swelling face, eye swelling, swelling of eyelids, itchy face and burning sensation was resolving. No follow-up attempts are possible. No further information is expected.
46 2021-07-04 peripheral swelling I am not sure if this would be considered a side effect or allergic reaction, however I am concerned... Read more
I am not sure if this would be considered a side effect or allergic reaction, however I am concerned as I broke out in hives all over my legs and ankles. My left leg also became slightly swollen. This event occurred 4 days after the first dose. Benadryl helps to relieve the symptoms.
46 2021-07-06 lymph node swelling, lymph node pain My lymph nodes in my left armpit swelled up to the size of half a baseball and they are very tender ... Read more
My lymph nodes in my left armpit swelled up to the size of half a baseball and they are very tender to the touch
46 2021-07-07 lymph node swelling Body aches and pains. Swollen lymph nodes - Underarm
46 2021-07-07 swelling Burn hash swollen neck swollen cough
46 2021-07-08 swelling On 4/5 I had discharge out of my left ear. On 4/9 I had to see an after hours doctor who said there ... Read more
On 4/5 I had discharge out of my left ear. On 4/9 I had to see an after hours doctor who said there was an abscess. There was a hole and pus, and blood were coming out. The left side of my neck was swollen. I also had pain in my neck and behind both my ears and inside my ears. On 4/13 I had to go to an after hours care because I had sudden onset nerve pain in my left lower back. It felt like sciatica. My pain level was a 9.5/10. I was given a cortisone shot which helped. On 4/16 I went to an ENT where I did an CT scan on my left side because my neck was still was still swollen. He did say my ear was healing. I was also sent to physical therapy which helped a little. On 4/18, I noticed that my right wrist carpal tunnel flared up. My right wrist became enflamed and my right upper arm began hurting. The lower back pain also became enflamed. The left side of my face hurt and inside my left ear, around the cartilage I had another sore. I also was experiencing a dry mouth.
46 2021-07-12 peripheral swelling A Week after first shot , pt's feet began to swell and became slowly impossible to walk. After 2nd V... Read more
A Week after first shot , pt's feet began to swell and became slowly impossible to walk. After 2nd VAX side effects became worse and led to pt not being able to walk with assistance.
46 2021-07-14 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Mild, Additional Details: PATIENT EXPIRIENCED BRUSHING AND ITCHINESS... Read more
Systemic: Allergic: Anaphylaxis-Mild, Additional Details: PATIENT EXPIRIENCED BRUSHING AND ITCHINESS NEAR THE INJECTION SITE AND ON FACE . PATIENT ALSO EXPIRIENCED NAUSEA. PATIENT SAID SYMPTOMS ARE GETTING BETTER. REFER TO SEE DOCTOR OR COME BACK TO PHARMACY IF ANY OF ABOVE MENTION SYMPTOMS GET WORSE
46 2021-07-17 lymph node swelling, swelling, neck mass I start itching on the left side of my neck; then I start feeling my neck was swollen and then I fel... Read more
I start itching on the left side of my neck; then I start feeling my neck was swollen and then I felt the lump in my neck.; then I start feeling my neck was swollen and then I felt the lump in my neck/ he my lymph node is like a knot like a ball, a little ball in my neck like a lump in my neck and it is swollen; You can feel that lymph node on the left side of my neck is swollen; I took the second dose I had my blood pressure ticked and that is when they gave me another medication/ when I took the second day they said it was 152 or 159 on that day; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0180, patient was 46-years-old at the time of vaccination), via an unspecified route of administration on 23Jun2021 as single dose for COVID-19 immunization. Medical history included blood pressure high and pain. Concomitant medication(s) included ongoing amlodipine (AMLODIPINE) 10 mg once a day taken for Blood pressure high; ongoing lisinopril (LISINOPRIL) 5 mg once a day taken for Blood pressure high; ongoing ibuprofen (IBUPROFEN) 600 mg as needed taken for pain; ongoing hydrochlorothiazide (HYDROCHLOROTHIAZIDE) 25 mg once a day taken for pain; ongoing gabapentin (GABAPENTIN) 300mg and take eight those a day taken for pain and ongoing Vitamin (VITAMINS NOS) once a day, patient mentioned that 'I am taking right now once a day vitamins pill but it will be nothing I don't have to take that.' Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0178, patient was 46-year-old at the time of vaccination), on 02Jun2021 as single dose for COVID-19 immunization and no reaction was experienced. On 23Jun2021, patient took the second dose and had her blood pressure ticked and that was when they gave her another medication. She was told it was 152 or 159 on that day and then she went to emergency on the 28th and they did it again it was at 159. Patient would be going back on the 7th to get re-tested again for high blood pressure. On 28Jun2021, the patient started itching on the left side of neck and then started feeling her neck was swollen and then felt the lump in the neck and get feeling movement around, so patient went to emergency and they told her that the COVID flared up her lymph node in neck. They said that lot of people had the lymph node issues, patient mentioned that she did not know that was the one of the symptoms because she did not have any of the other symptoms. Patient was told that the lymph node was like a knot like a ball, a little ball in neck like a lump in neck and it was swollen. Patient reported that one can feel that lymph node on the left side of neck was swollen. Patient was not given any treatment for it. Patient reported that it was still swollen and it was in the same spot at the time of reporting. Patient was told to give it a couple of weeks to see if goes down or if gets bigger or call emergency to go back in emergency or call back primary. The outcomes of events were not recovered. Follow-Up (06Jul2021): Follow-up attempts are completed. No further information is expected.
46 2021-07-17 lymph node swelling I was lethargic the day after with a bad headache. I slept for about 3 hours. A few days later, I de... Read more
I was lethargic the day after with a bad headache. I slept for about 3 hours. A few days later, I developed one large spot of shingles in the center of my back. I took a picture of it and sent it to my doctor. She agreed that it looked like shingles, so I came in for an appointment. She started me on some medicine for the shingles. I applied calamine lotion and some hydrocortisone to the lesion as needed for pain. I took Acetaminophen for pain. The lesion improved after a couple of weeks and it did not spread. It reoccurred again 8 weeks later with more lesions. I took another picture for my doctor and she prescribed the same medicine. I basically repeated what I did the first time. She told me to come in if it got any worse. It took about 3-4 weeks for them to go away. I got swelling at the injection site. I had a swollen lymph node on the right side of my arm. It was very painful.
46 2021-07-17 lymph node swelling swollen nodes in armpit that same evening.; Sore neck glands 2days after shot; Swollen Lymph Nodes o... Read more
swollen nodes in armpit that same evening.; Sore neck glands 2days after shot; Swollen Lymph Nodes on right side of body.; Unusual Right knee pain next morning/day after shot; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration in the right arm on 24Mar2021 at 17:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included beclometasone dipropionate (QVAR) and levothyroxine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN); all for unspecified indications, from unspecified start dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the right arm on 03Mar2021 at 17:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 03:00, the patient experienced swollen lymph nodes on right side of body and unusual right knee pain next morning/day after shot, and gone by following day morning. On 26Mar2021, patient had sore neck glands followed by swollen nodes in armpit that same evening. Day 3 after receiving the vaccine, nodes were still swollen. All issues are on right side of body. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The clinical outcome of right knee was recovered on 26Mar2021 and sore neck glands, swollen nodes in armpit, and swollen lymph nodes was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
46 2021-07-17 oral herpes Shingles left lower abd. 2 cold sores on face; Shingles left lower abd. 2 cold sores on face; This i... Read more
Shingles left lower abd. 2 cold sores on face; Shingles left lower abd. 2 cold sores on face; This is a spontaneous report from a contactable Nurse (Patient). A 46-year-old non pregnant female patient received BNT162B2 (PFIZER-BIOTECH COID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8734, Expiration date: Not reported), via an unspecified route of administration, administered in Arm Right on 14May2021 (age at vaccination 46-year-old) 12:15 as single dose for covid-19 immunization. Medical history included known allergies PCN, Sulfa, ongoing eosinophilic oesophagitis (EoE), allergies, The patient had covid-19 prior to vaccination. Concomitant medication included omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) at 80 mg daily taken for EoE. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20May2021 12:00 the patient experienced shingles left lower and, 2 cold sores on face. Since the vaccination, patient was not been tested for COVID-19. Therapeutic measures were taken as a result of the events with Acyclovir. The outcome for the evens was reported as recovering.
46 2021-07-17 peripheral swelling she has a tennis ball size knot in her arm; headaches; lightheadedness; she has also been coughing u... Read more
she has a tennis ball size knot in her arm; headaches; lightheadedness; she has also been coughing up yellow and green liquid; scratchy throat; she still has stiffness in her neck; swelling she has had at the injection site; arm swollen from the base of her neck down to her elbow on her left arm; she was in pain the entire day; Injection site pain with redness; tiredness; injection site pain; muscle pain; she only felt warm/hot at area of injection; red in the injection arm; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0185), via an unspecified route of administration, administered in left arm on 22Jun2021 at 10:00 (at the age of 46-year-old) as a single dose for covid-19 immunisation at other facility. The patient medical history included gastric Bypass Surgery from 2019 to an unknown date (she had herself checked because she did have bariatric surgery in 2019 and she has to do a checkup). Concomitant medications included ibuprofen (ADVIL) (Expiration Date: 19May2021). The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection Lot number: EW0121, Expiration Date: unknown), administered in left Arm on 01Jun2021 at 10:30 as a single dose for COVID-19 immunization and experienced pain at the injection site and sore arm (that went away in 2 days). The patient previously received Pneumonia vaccine and Flu Vaccine for immunization and experienced flu and pneumonia (stated she was hospitalized after receiving the vaccines. NDC, Lot, Expiration: Unknown. She does not get sick with the flu unless she takes a flu vaccine, and she does not get pneumonia unless she gets a pneumonia vaccine, she got this vaccine and now she is sick, she will not do a vaccine ever again). Patient did not administer additional vaccines on Same Date of the Pfizer Suspect. Patient did not receive any prior Vaccinations (within 4 weeks). Patient did not have family medical history relevant to adverse events (no one she knows of had a reaction). Patient received second dose on 22Jun2021 and reports tiredness, injection site pain/with redness and felt warm/hot at area of injection, muscle pain, scratchy throat, swollen and red in the injection arm, also with now a tennis ball size lump there along with headaches and migraine, light headedness and coughing up green and yellow liquid (she does have sinus issues so she was not attributing it all to the vaccine, but she usually has a tan color, and this was yellow and green). She said that she also get the flu and Pneumonia after receiving those vaccines and she had a green and yellow like mucous, the next morning (23Jun2021) noticed swelling from the base of her neck to the elbow/ arm swollen from the base of her neck down to her elbow on her left arm on the side the injection was given, also states unable to turn her head to the left all the way/ Stiffness in neck cannot turn her neck to the left, turns entire body around to look. She has read some of these symptoms on the paper but not all and would like to know what to do. On 24Jun2021, the patient had tennis ball size knot in her arm, warm to the touch. Patient was upset that she has to consult her doctor in order to get help and that is where this is where this was faulting, that is where she felt like maybe she has been injected with something to track her and all these other things are flooding through my mind as to it relates as to why it was so important for us to get a vaccine, was not having that at first but now she was thinking that and she did not want her daughter to get it, completely blind and has to go to school to be educated, not comfort, but they decided to take it as a family. She was calling because she took her second shot on Tuesday morning and she was in pain the entire day and then she woke up the very next day with her arm swollen from the base of her neck down to her elbow on her left arm and now the swelling partially has gone down, but she has a tennis ball size knot in her arm. She stated the only way she got the swelling to go down was by taking Ibuprofen and a muscle relaxer. Patient stated on top of that, she has headaches, lightheadedness and she is now on day 4 after the vaccine. She stated she was coughing up yellow and green liquid and she does have sinus issues so she is not attributing it all to the vaccine, but she usually has a tan color, and this is yellow and green. She wants to report this because she does not know what she is supposed to do, especially after the second shot. Patient stated the symptoms they list, she has had some, but she has not had joint pain, she has had tiredness, injection site pain and muscle pain, but no joint pain, no chills, no fever, and she only felt warm/hot at area of injection. The swelling she has had at the injection site with swelling and redness, her arm was noticeably swollen, she was heavy set but if she would have shown her arm on Wednesday, it was obviously swollen. She has had no nausea, but she does have a scratchy throat. Patient enquired if is this normal or is she supposed to feeling this way. She stated if not, she needs something to be done. She states she is not one that does well with vaccines and after getting the flu and pneumonia vaccines before, she has been hospitalized. She does not know if she needs to go to the ER. Flu and Pneumonia Vaccines: NDC, Lot, Expiration: Unknown. After her first dose, she had pain at the injection site and so did her entire family, but they had that pain for 2 days and then it went away. She still has stiffness in her neck, the tennis ball knot in her arm, she is still tired but functionable, headaches but does not feel like a migraine like the last 2 days. The only thing that has recovered is the swelling, well she does not have as much swelling, just the tennis ball size knot. Yesterday morning the swelling was gone but the knot is still there and it is warm to the touch and had stiffness in her neck and she cannot turn her neck to the left, she turns her entire body around to look. Patient received Treatment: Ibuprofen and Muscle Relaxer, she only took it once yesterday because the pain was so bad. and could bear it on Wednesday but Thursday it was too bad, she had an old muscle relaxer from a couple of years ago that she had in the closet and so she took one of those and 2 Advil/Ibuprofen 400mg and the 5mg muscle relaxer. She took that and it put her to sleep and that helped with some of the pain. Advil/Ibuprofen: UPC, Lot, Expiration: Advil 250mg coated. 49035-604-85 Expires: 19May2021. Muscle Relaxer: Adverse Event, took a muscle relaxer from a few years ago that was prescribed for something else. Cyclobenzaprine 5mg; NDC, Lot, Expiration: Unknown, Pharmacy Bottle. Date filled: 26Oct2019 discard after Oct2020. Patient stated that she does not do well with vaccines but she could not stomach giving her daughter a vaccine that she would not take, now she feels she should not have taken it and just kept taking her natural immune boosters and vitamins because she did fine. She was around people that had Covid 19 and she has been around lots of people and traveled and was fine. She would not have taken that vaccine. Her vitals and blood work and everything were tested, and the only thing she needs more of Iron and Vitamin D. The only tests that came back that she needed to be aware of and do something about, outside of that nothing. States she was going to the doctor to get an iron infusion. Patient did not visit emergency room and physician Office for the events. She looked on the sheet and most of her side effects were on there, so she thought this is normal. She looked at the swelling on her arm and neck and thought this is just temporary and she took a muscle relaxer, used ice, heat pad, and thought she would see how that works. There was no investigation assessment and no relevant tests. The outcome of events arm swollen from the base of her neck down to her elbow on her left arm/swelling she has had at the injection site was recovered on 24Jun2021, recovering for headaches and rest of the event was not recovered. Follow-up attempts are completed. No further information is expected.
46 2021-07-17 swelling face This is a spontaneous report received from a non contactable consumer, the patient. A 46-year-old no... Read more
This is a spontaneous report received from a non contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration on left arm on 25Mar2021 at 14:30 (at the age of 46- year-old) as a single dose, for COVID-19 immunisation. Past medical history included Novocain allergy. Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 15:15 the patient experienced difficulty breathing, red and slightly swollen face, irregular pulse, dizziness. The event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. No therapeutic measure was taken in response to the event. The clinical outcome of the event difficulty breathing, red and slightly swollen face, irregular pulse, dizziness was resolving at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
46 2021-07-17 swelling face Swelling of my face and throat, dizziness, injection site pain, arm pain, headache, tiredness, muscl... Read more
Swelling of my face and throat, dizziness, injection site pain, arm pain, headache, tiredness, muscle pain, feeling unwell, shortness of breath a little bit
46 2021-07-18 anaphylactic reaction Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Diffi... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Severe, Systemic: Weakness-Severe
46 2021-07-18 lymph node swelling Arm Pain 6pm, Headache the following 2 days all day long, brain fog the following day of vaccine, Di... Read more
Arm Pain 6pm, Headache the following 2 days all day long, brain fog the following day of vaccine, Diarrhea 4 days now, glands under arm (same with injection) swollen painful days 3 and 4 after vaccine, 2nd night had insomnia, days 3-4 had restless legs at bedtime.
46 2021-07-18 peripheral swelling After having the vaccination and waiting 15 minutes at my PCP's office I left. My husband was drivin... Read more
After having the vaccination and waiting 15 minutes at my PCP's office I left. My husband was driving and took me to a local supermarket where I shopped for a short time and then returned home. My home, the PCP and the supermarket are all within close proximity. Upon return home, I was walking in front of my husband, wearing an ankle boot prescribed by my Podiatrist, and a skirt. My husband asked why my left leg calf was twice the size of my right. I entered our home, set in the recline, removed the ankle boot and noticed a huge amount of swelling from my left foot to just up above my left knee. It was indeed twice the size, perhaps a bit more, than my right side. Also, just below my left, on the side of my inside calf, there was an XL raised, red, clearly outlined/defined area. approximately 4 inches by 2.5/3 inches. There was pain within the area and radiating. I immediately took an aspirin and called my podiatrist thinking that the ankle boot was causing this. (the vaccine did not even enter into my mind) I had to leave a message on the machine at the podiatrist's office and received a return call within 2 to 3 hours by a RN telling me to go to closest ER ASAP. In the meantime while waiting to hear back, I remained seated with leg elevated . I went to ER. I was seen very quickly, ultrasound was provided to rule out DVT. By the time I reached the ER (approximately 1:30), the mass had significantly decreased. The ultrasound showed no DVT. The ER MD diagnosed most likely superficial blood clot and it would not have been caused by boot. Made contact with RN at PCP, she instructed me to file report with CDC.
46 2021-07-19 peripheral swelling Next after the vaccine dose (6/30/21), the patient begins feeling symptoms: a red rash on the side ... Read more
Next after the vaccine dose (6/30/21), the patient begins feeling symptoms: a red rash on the side of the stomach, on arms and part of the legs, swollen foot. The symptoms last until July 9th. The patient used Benadryl as treatment- (didn't work). The rash left her with light brown spots.
46 2021-07-21 lymph node swelling swollen lymph nodes; Difficulty opening mouth wide and swallowing; Mild sore throat; This is a spont... Read more
swollen lymph nodes; Difficulty opening mouth wide and swallowing; Mild sore throat; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 28Mar2021 at 09:30(at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 15:00 the patient experienced Sore throat and difficulty opening mouth wide and swallowing. On 02Apr2021, the patient experienced swollen lymph nodes. The patient did not receive any treatment for the events. The clinical outcome of the event Sore throat, difficulty opening mouth wide and swallowing and swollen lymph nodes was not recovered. No follow-up attempts are needed. No further information is expected.
46 2021-07-21 peripheral swelling, lymph node swelling, swelling, swelling face large bump under her armpit; Her chest is swelling; chest pain; shortness of breath, difficulty brea... Read more
large bump under her armpit; Her chest is swelling; chest pain; shortness of breath, difficulty breathing; Has a headache; Lymphadenopathy in ears and throat; Left foot hurts right under the knee; Joint pain and inflammation; joint pain and inflammation; She has been feeling really bad; Her hand is swollen; Breast on side of bump under the armpit is inflamed and hurts; Lumps behind her ears, in her groin, and in her hands; Throat and neck hurt and look swollen; Throat and neck hurt and look swollen; Left side of her back and all of this hurts; Her face was swollen and her eyes and head hurt; her face was swollen and her eyes and head hurt; her face was swollen and her eyes and head hurt; itching and she had it on the bottom of both feet; exhausted and tiredness; dizziness and nauseous; dizziness and nauseous; lump at vaccine site; she felt like vomiting and vomited a couple of times; Diarrhea; fever; weakness; first vaccine 23FEB2021 and second vaccine 29JUN2021; first vaccine 23FEB2021 and second vaccine 29JUN2021; eyes swollen and can not see well; This is a spontaneous report from a contactable consumer or other non hcp. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 29Jun2021 (Batch/Lot Number: EW0179) as dose 2, single for covid-19 immunization. Medical history included ongoing thyroid disorder, hypertension, diabetes mellitus, kidney infection from an unknown date she went to the hospital 3 weeks ago, to the emergency room, because of a kidney or urine infection and it still hurts, but they still hurt at the time of report, allergy to vaccine from 23Feb2021, allergic to first dose: ongoing asthma. The patient received first dose of bnt162b2 on 23FEB2021 via an unspecified route of administration (Batch/Lot Number: EL9266) as dose 1, single for covid-19 immunization. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced large bump under her armpit, chest was swelling, chest pain, shortness of breath, difficulty breathing, headache, and lumps behind her ears, in her groin, and in her hands; throat and neck hurt and look swollen, left side of her back and all this hurts and it was right under the knee. Her left foot hurts. She had joint pain and inflammation. She had been feeling bad and she had been several days with these symptoms. Also, her hand was swollen, breast on side of bump under the armpit is inflamed and hurts, she said that the large bump was under her armpit started first. Face was swollen and her eyes and head hurt. Caller again states that the lump was in her hand, there was the chest, and her back, and it hurts to breathe, and she inhaled a spray that she had for asthma. She noticed there was the itching and she had it on the bottom of both feet all the way up to her feet. Itching and she had it on the bottom of both feet. she was applying ointment and was scratching and there was some inflammation like when someone has allergies and starts scratching but it was the bottom of her feet, she suffered from allergies and she thought it was that but that was what she had the previous day. she felt exhausted and tiredness, dizziness and nauseous. She said her arm where she received the vaccine on, she never had pain on the side of the vaccine, but then she started on a lump on Wednesday, there was pain and itchiness and swelling as previously captured. She felt like vomiting and vomited a couple of times, she had diarrhea and fever. she did not feel like getting up because of the weakness and chest pain, and then that was when she noticed the right-side breast kind of bulky and swelling and then the lump got larger. Her Eyes swollen, she put on her glasses because she could not see well because her eyes were swollen. she was outside the ER right now and had not stepped in yet because of the questions she was answering. she had been taking Naproxen for the pain and using ice packs. She had inflammation very strong in joints, swollen hand and had felt bad for days. She states she is still experiencing shortness of breath, and she feels exhausted and tiredness, dizziness and nauseous, and a headache. Caller was asked regarding symptoms improving, worsening, or persisting and states that just yesterday and today early this morning and before dawn she started to feel different. The patient received treatment for the events. The outcome of the events was Unknown. Information on the lot/batch number has been requested.
46 2021-07-21 peripheral swelling Within 24 hour, high fever 102 and body aches that lasted for 6 days. On Jan 12, 2021 contacted COVI... Read more
Within 24 hour, high fever 102 and body aches that lasted for 6 days. On Jan 12, 2021 contacted COVID line, recommend rest and fluids, no recommended to Test for COVID. After fever reduced, rash on both legs appeared approx Jan 18th. On Feb 2nd Went to Express care after this rash didn't go away. Was told it was exzcema given Kenalog cream and Atarax and to follow up with PCP if not better in 10 days. Sent message to PCP with photos of rash and recommendation. Referal completed for Dermatology. Had appt on Feb 22 but rash had cleared up prior to appt. Was advised to call if reappeared. Approx April 13 rash reappeared. Used Kenalog as before but no difference. On April 20, 2021 Contacted Dermatologist was advised to continue using kenalog. On April 22 contacted Dermatologist again to advise that rash is getting worse and had spread more to thighs rather than just lower leg area. Was prescribed betamethasone dipropionate .05% ointment. April 23 rash remained the same, experienced swelling in lower extremities. towards evening lower calves were swollen to same size as thighs. Asked husband to take me to express care. On the way to express care, i began experiencing numbness on the right side of my body and was taken to Emergency Room. At the emergency room, began having trouble formulating words. Was worked up for possible stroke. Stroke was ruled out but no answers as to why i experienced the stroke like symptoms. Rash was examined and prescribed prednisone and follow up with Dermatology on April 26. Met with Dermatology on April 26 and a biopsy was performed resulting in diagnosis of dermal hypersensitivity reaction. Over the course of the next few weeks, I had swelling off and on in my legs like what lead me to the emergency room on April 23 but no rash was present. I made contact with PCP on May 19th to advise of the swelling and was requested to come to the office. As a result of the office visit, an ultrasound was requested of my right leg which indicated a DVT. I have since started blood thinners and continue to follow up with providers as necessary.
46 2021-07-25 swelling face Left side of face swollen Left side of mouth and tongue burning Vomiting Left side of Throat hurt... Read more
Left side of face swollen Left side of mouth and tongue burning Vomiting Left side of Throat hurts feeling of something lodged on left side of throat Body pain Onset headaches
46 2021-07-27 lymph node swelling Lymph node is swollen and uncomfortable under left arm pit.; Uncomfortable under left arm pit.; This... Read more
Lymph node is swollen and uncomfortable under left arm pit.; Uncomfortable under left arm pit.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 05Apr2021 at 10:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, migraines, seasonal allergy and allergy to NSAIDS. Concomitant medications included tizanidine (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN), sumatriptan (IMITREX), paracetamol (TYLENOL) and multi v (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 15Mar2021 at 10:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation and took aspirin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 06:30, the patient experienced lymph node was swollen and uncomfortable under left arm pit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events lymph node was swollen and uncomfortable under left arm pit was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
46 2021-07-27 lymph node swelling Left arm pit accompanied by pain and discomfort.; Left arm pit accompanied by pain and discomfort.; ... Read more
Left arm pit accompanied by pain and discomfort.; Left arm pit accompanied by pain and discomfort.; Severe swelling of the lymph node; Fever of 37.9; Severe pain in left arm; This is a spontaneous report received from a non-contactable consumer (patient). A 46-year-old non-pregnant female patient received BNT162B2 (COVID-19 VACCINE-MANUFACTURER UNKNOWN; Lot Number: ew0151), via an unspecified route of administration in the arm left on 01Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 prior to vaccination on an unspecified date. The patient had history of known allergies to nickel. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL); all from an unknown dates taken for unknown indications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced left arm pit accompanied by pain and discomfort on 02Apr2021, at 16:00 with outcome of recovering, severe swelling of the lymph node on 02Apr2021, at 16:00 with outcome of recovering, fever of 37.9 on 02Apr2021, at 16:00 with outcome of recovered on 04Apr2021, severe pain in left arm on 02Apr2021, at 16:00 with outcome of recovering. Details were as follows: on 02Apr2021 at 16:00, 24 hours following the injection, the patient experienced fever of 37.9 which lasted for almost two days. Severe pain in the left arm. Severe swelling of the lymph node in the left arm pit accompanied by pain and discomfort were noted. The lymph was visibly swollen 4 days after the injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the left arm pit accompanied by pain and discomfort, severe swelling of the lymph node and severe pain in left arm was recovering; fever of 37.9 recovered on 04Apr2021. Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities. No follow-up attempts are possible. No further information is expected.
46 2021-07-27 lymph node swelling swollen and very sore lymph nodes in armpits, neck and groin area; bleeding gums; This is a spontane... Read more
swollen and very sore lymph nodes in armpits, neck and groin area; bleeding gums; This is a spontaneous report from a contactable pharmacist (patient). A 46-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 at 10:30 as DOSE 2 (Age at Vaccination: 46), SINGLE for covid-19 immunisation. Medical history included mastectomy (2010 to an unknown date). The patient had no known allergies. There were no concomitant medications. The patient received dose 1 of bnt162b2 on 03Feb2021 for covid-19 immunisation (vaccine location: Left arm, lot number: EL9264). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced swollen and very sore lymph nodes in armpits, neck and groin area and bleeding gums on 25Feb2021 at 02:00. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of both the events was not recovered. Information about Lot/batch number has been requested. Follow-up (13May2021): Follow-up attempts completed. No further information expected.
46 2021-07-27 oral herpes Multiple cold sores on lips; Fungal infection in mouth; This is a spontaneous report from a contacta... Read more
Multiple cold sores on lips; Fungal infection in mouth; This is a spontaneous report from a contactable consumer, the parent. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO0171) via an unspecified route of administration in the right arm on 23Apr2021 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included Angelman syndrome with severe disability and COVID-19. Concomitant medications included phenobarbital (MANUFACTURER UNKNOWN) and clonazepam (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL2613) via unspecified route of administration in the left arm on 02Apr2021 (at the age of 45-year-old) as single dose of COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Apr2021, the patient experienced, multiple cold sores on lips and fungal infection in mouth. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received glucose azole (MANUFACTURER UNKNOWN) as a treatment for the events multiple cold sores on lips and fungal infection in mouth. The clinical outcome of the events cold sores on lips and fungal infection in mouth were resolving at the time of report. No follow-up attempts are needed. No further information is expected.
46 2021-07-27 peripheral swelling Right leg swelling, right arm ached and I had a headache on my right side, nausea and chills, and fe... Read more
Right leg swelling, right arm ached and I had a headache on my right side, nausea and chills, and felt very tired. I went to the hospital and got an IV, I had 186 blood pressure. I was there for 9 hours. My blood pressure went down to 176/100 and left to go home. I did not receive any medication for leg and arm pain but did get a shot for the pain. I was referred to a primary doctor.
46 2021-07-28 axillary mass Swelling/soft lump under left arm pit; Tender to touch; This is a spontaneous report from a contacta... Read more
Swelling/soft lump under left arm pit; Tender to touch; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP8732) via an unspecified route in left arm on 02Apr2021 at 12:00 (at the age of 46-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The medical history of patient included Crohn's disease. Concomitant medications included rosuvastatin calcium (CRESTOR), glucosamine (MANUFACTURER UNKNOWN), mesalazine (LIALDA) and mesalazine (CANASA) started on an unknown date for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route in left arm on 12Mar2021 at 09:30 hours as single dose for COVID-19 immunisation. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Post the vaccination, the patient was not tested for COVID-19. On 03Apr2021 at 20:00, the patient had swelling/soft lump under left arm pit and tender to touch. No treatment was given for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swelling/soft lump under left arm pit and tender to touch was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
46 2021-07-28 herpes virus infection Herpes outbreak 72 hours after second dose; This is a spontaneous report from a contactable consumer... Read more
Herpes outbreak 72 hours after second dose; This is a spontaneous report from a contactable consumer or other non hcp (patient reporting for herself). A 46-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in arm right on 16Jul2021 at 16:00 as dose 2, single dose for covid-19 immunization (at the age of 46-years-old). Medical history included ovarian cyst and fibroids from an unknown date and unknown if ongoing and patient had known allergies of gluten, MSG (monosodium glutamate) and quinoa. Concomitant medication(s) included clonazepam (KLONOPIN) taken for an unspecified indication and start and stop date were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19. Since the vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Doctor's office/urgent care. It was reported that the patient experienced herpes outbreak 72 hours after second dose of vaccine on 19Jul2021 at 17:00. The adverse event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received the treatment for the event. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
47 2021-01-03 swelling face 12/23 within 2 mins after the vaccine I felt light headed and I felt like I was going to pass out m... Read more
12/23 within 2 mins after the vaccine I felt light headed and I felt like I was going to pass out my heart was beating really hard, it started to mellow out and my face swelled up about an hour after. I was told to go to the ER and I took oral Benadryl and it went away and did not return
47 2021-01-03 swelling EE presented to EH with c/o hives to face and racing heart rate at 1445
47 2021-01-04 peripheral swelling All of sudden I started feeling bad, I mean it just hit me; Fever; Headache; I am very nauseous; My ... Read more
All of sudden I started feeling bad, I mean it just hit me; Fever; Headache; I am very nauseous; My left arm started swelling, it started in fore arm and it started getting marks on it; pain in arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in her right arm on 21Dec2020 at single dose for covid-19 immunization. Medical history included Blood pressure high, Attention deficit hyperactivity disorder (ADD), depression and cancer four years ago and she didn't have any left node in left arm. Concomitant medications included losartan (LOSARTAN) for Blood pressure high, venlafaxine hydrochloride (EFFEXOR) as antidepressant, tamoxifen (TAMOXIFEN) for her cancer and it was hormone blocker, lisdexamfetamine mesilate (VYVANSE) for ADD. The patient received the vaccine last this last Monday on 21Dec2020, in her right arm, she was fine, on Thursday on 24Dec2020 like all of sudden she started feeling bad, she mean it just hit her. She had fever, she was very nauseous and her arm, her left arm started swelling, it started in forearm and it started getting marks on it. Anyway she went go and got tested for Covid yesterday 26Dec2020 because in middle of night, that night I felt so bad. She have got just headache on 24Dec2020, its most of that before then. Anyways she had just got her results back that was negative but so she didn't know that her arm, it was the opposite arm. The patient still experiencing pain in arm, she haven't had fever in last night and she haven't checked it today. She took Tylenol and she called her doctor yesterday and they made of me some antibiotics for her arms, probably the 7mg and the patient guess it is every 8 hours. The outcome of the event pain in arm was not recovered and the outcome of the other events was unknown. Information on the lot/batch number has been requested.
47 2021-01-05 white blood cell count increased Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents w... Read more
Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon. Patient states that she received her second Covid vaccination yesterday and began developing symptoms today. States she had a temperature of 102. She is a nurse here in the rehabilitation center. She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools. She has had no urinary symptoms. She denies any leg swelling or pain. No history of DVT or pulmonary embolism. No recent travel, immobilizations, surgeries, bedrest or history of malignancy. No hemoptysis. Again, no cough. Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history - Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen. Symptoms are consistent with side effects of the Covid vaccine. She does not appear ill appearing. She has no fever at this time. She does state that her symptoms are somewhat improved. Chest x-ray and labs are otherwise unremarkable. Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen. This is the patient's second dose of vaccine for Covid.
47 2021-01-06 lymphatic obstruction Sudden severe headache followed by severe joint pain (elbows, knees, neck and back) and axillary and... Read more
Sudden severe headache followed by severe joint pain (elbows, knees, neck and back) and axillary and left arm lymphedema and left breast swelling.
47 2021-01-06 swollen extremities Pitting edema/Edema: It was her feet, ankles, and 3/4 way up her shins.; This is a spontaneous repor... Read more
Pitting edema/Edema: It was her feet, ankles, and 3/4 way up her shins.; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730, expiry date: Mar2021), intramuscular in the left deltoid on 17Dec2020 at 07:15 at single dose for COVID-19 immunization. Medical history included ongoing neuralgia since 2003 (has nerve pain in her face and neck. It has never caused swelling and that she has had it for a long time. Symptoms started 17 years ago, became apparent in 2009), ongoing hypothyroidism since 2003 (Diagnosed about 17 years ago. Nothing has changed medication wise). The patient's concomitant medications were not reported. The patient reported that she got the vaccine on 17Dec2020. On 25Dec2020, her shoes felt snug and by the next day she had 4 plus pitting edema. She could not fit in the shoes. She had the pitting edema for several days. She said that she went and bought compression stockings to help with the edema. It was her feet, ankles, and 3/4 way up her shins. It was more of the pedal area that was pitting. The patient further reported that she never had pitting edema before and the only thing new she had was the vaccine. Therapeutic measures were taken as a result of the event which included compression stockings. The patient was recovering from the event.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported event pitting edema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
47 2021-01-06 peripheral swelling Approximately 30 minutes after vaccination she had swelling and redness in her hands and small hive ... Read more
Approximately 30 minutes after vaccination she had swelling and redness in her hands and small hive and redness on her chest. Symptoms lasted for about 2 hours and she took benedryl.
47 2021-01-06 swelling SkinRash swelling Narrative:
47 2021-01-06 swelling Roughly 9 days after first vaccine, noticed your right hand middle finger became purple, with pins a... Read more
Roughly 9 days after first vaccine, noticed your right hand middle finger became purple, with pins and needs sensation. This was followed by some swelling. Improved over 24 hours. Still feeling "tight" in knuckles.
47 2021-01-07 lymph node swelling, lymph node pain Lymph node swollen under arm of injection site to the size of a golf ball also associated pain at ly... Read more
Lymph node swollen under arm of injection site to the size of a golf ball also associated pain at lymph node site.
47 2021-01-07 lymph node swelling swollen supraclavicular lymph node; headache; chills; soreness to injection site for 2 days; This is... Read more
swollen supraclavicular lymph node; headache; chills; soreness to injection site for 2 days; This is a spontaneous report from a contactable nurse, reporting for a patient. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, via intramuscular on 22Dec2020 at 14:45 (at the age of 47 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included asthma, celiacs, and hypertension from an unknown date. The patient had known allergies to shellfish, latex, sulfa, Levaquin, Morphine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydrochlorothiazide, zyrtec, dicyclomine, ibuprofen, benadryl, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 23Dec2020, the patient experienced soreness to injection site for 2 days (23Dec2020 and 24Dec2020). On 26Dec2020 at 16:00, she started having chills and headache. On 27Dec2020 chills were to the point where she couldn't get warm. Shivering chills. She remained afebrile just bad chills for 2 days. On 28Dec2020, she noticed swollen supraclavicular lymph node to left clavicle area which was painful to touch and approximately quarter in size. It was not as painful today and swelling was starting to subside. The patient did not receive treatment for the events. The clinical outcome of soreness to injection site for 2 days was recovered on 25Dec2020. The clinical outcome for headache, chills, and swollen supraclavicular lymph node was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
47 2021-01-10 lymph node swelling vaccine reaction started 12/27/2020 muscle aches on left side of body, both left arm and leg, can o... Read more
vaccine reaction started 12/27/2020 muscle aches on left side of body, both left arm and leg, can only say it is what I would imagine restless leg syndrome might feel like, weak and achy that disrupted sleep all night. 12/28/20 noticed enlarged lymph node on left side near clavicle tender to touch
47 2021-01-10 lymph node swelling Axillary lymphadenopathy, severe fatigue for two days
47 2021-01-10 oral herpes ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consume... Read more
ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consumer reported for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number: EK5730; dosage form: injection) via an unspecified route of administration as injection to left arm on 24Dec2020 at 7:30 am at a single dose for COVID-19 immunization. Relevant medical history and concurrent conditions included slight hypertension from Jul2020 and ongoing. Concomitant medications included lisinopril from Jul2020 and ongoing for slight hypertension. The patient developed ball palsy, facial dropping which did not lasted long but she still had the painful shingles on 27Dec2020, after the first dose. She wanted to know the recommendations for taking the second dose which is due in 10 days. The patient wanted to know if she should receive the shingles vaccine. This caller was a lab tech who works in the healthcare industry and manages a medical office; but clarified she did not call on behalf of a healthcare professional. She was the patient who received her first dose of Pfizer SARS-CoV-2 Vaccine on 24Dec2020. She reported onset of what the Urgent Care Physician believed was Shingles on 27Dec2020. She called to ask if she should or should not receive the second dose of Pfizer SARS-CoV-2 Vaccine on 14Jan2021 as scheduled due to the Shingles. The Urgent Care Physician advised her to still get the second dose, as there was about a 1:10,000 chance of developing shingles with the vaccine. She reported shingles as a reaction subsequent to the Pfizer SARS-CoV-2 Vaccine. Initially on 27Dec2020 she developed sites of what she thought were canker sores or fever blisters in her mouth which had gotten pretty large and stopped her from being able to eat on 29Dec2020. Then on 30Dec2020 she developed sites on her face which have gotten scarily large; and was causing some deep nerve pain going to her eye and down her chin; the sites felt like lesions on her face with roots. The sites in her mouth were now completely gone; but the sites on her face are ongoing. Now it has kind of taken over her face. She saw the Urgent Care Physician regarding this who believed the sites to be shingles. She had never had fever blisters or shingles before this event. She was still kind of reeling. The report was reported as non-serious. The outcome of event ball palsy/facial dropping was resolved and of shingles was unknown.
47 2021-01-11 anaphylactic reaction Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortnes... Read more
Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness; Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization. There were no known medical history or concomitant medications. The patient previously received the first dose of BNT162B2 on 18Dec2020 (Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10 minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN). Later on 08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen (MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
47 2021-01-11 lymph node swelling Woke up 1/9/21 with pain in my L axilla and swelling. Improved with ice and ibuprofen. Continued t... Read more
Woke up 1/9/21 with pain in my L axilla and swelling. Improved with ice and ibuprofen. Continued to get better of the course of 3 days. No fever but felt ache all over and chills starting 1/8/21 about 8PM, pain in L arm 1/8/21 starting about 2 hours after injection. resolved 1/10/21
47 2021-01-11 peripheral swelling, swelling face tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole f... Read more
tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole face/swelling; dizzy; felt like she was floating/felt like she could get a nosebleed; teeth hurt; hands were swelling and it's hard to write; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at a single dose as vaccine. Medical history and concomitant medications were not reported. It was reported that received vaccine today, 06Jan2021, at 11:00. The patient's tongue was thick, she had numbness on face that started on the left side but now her whole face was numb and swelling. She was dizzy and felt like she was floating, her teeth hurt, her hands were swelling and it's hard to write, and felt like she could get a nosebleed. She took two Benadryl at 12:06 that expired in 2013 and then 2 more Benadryl at 1:08 that do not expire until 2022. She inquired if should she seek medical attention or ride this out and if should she follow through with her second dose of the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
47 2021-01-11 peripheral swelling Reported to vaccine clinic approximately 4 hours after receiving dose one of Pfizer Covid-19 vaccine... Read more
Reported to vaccine clinic approximately 4 hours after receiving dose one of Pfizer Covid-19 vaccine with complaints of itching, burning feeling on skin and swelling in left arm. Red rash on chest and left arm. No sob, chest pain or difficulty swallowing. Ambulated to emergency room for evaluation.
47 2021-01-12 peripheral swelling approx. 19 mins after the injection my right arm began to feel a tingle sensation that radiated down... Read more
approx. 19 mins after the injection my right arm began to feel a tingle sensation that radiated down to my hands and right side of my chest. Lips felt swollen but not visible to the eye. My right lower extremity had the same feeling as describe what happened to my right arm. I went to the ED of the hospital where I worked. This my second dose and I had the same experience with the first dose but on my left side.
47 2021-01-12 swelling Patient's report: "Started to notice swelling in my right arm pit on 1/12/2021 and tenderness in my ... Read more
Patient's report: "Started to notice swelling in my right arm pit on 1/12/2021 and tenderness in my neck also on 1/12/2021 I had the second shot on 1/11/2021 at 12pm"
47 2021-01-13 axillary mass, lymph node swelling 12 hours after receiving the vaccine (at 11:00pm on Saturday), I woke with nausea, stomach pains and... Read more
12 hours after receiving the vaccine (at 11:00pm on Saturday), I woke with nausea, stomach pains and the chills. I was up the remainder of the night. By morning I had a bad headache and terrible body/muscle aches. I was unable to report to work that day. By midafternoon, the nausea and stomach pains subsided, all other symptoms remained along with then getting a 100.5 fever. I was taking Tylenol every 4 hours since 1am and keeping hydrated. By midnight I was exhausted and was finally able to sleep. I woke the following morning with a dull headache and just felt achy. I felt much better by that evening (now Monday). Tuesday morning I woke with discomfort to my left armpit and clavicle area. I then noticed swelling, the areas felt ?lumpy? and were very tender to touch. That lasted about 2 days.
47 2021-01-13 lymph node swelling THREE DAYS WITH SINTOMES , PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN,CHILLES,PAIN JOINTS,FEVE... Read more
THREE DAYS WITH SINTOMES , PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN,CHILLES,PAIN JOINTS,FEVER,SWELLING INJECTION SITE,NAUSIAS GANGLIOR INFLAMATION.PAIN ALL HER BODY.
47 2021-01-13 peripheral swelling intense itching on back, neck, & scalp- muscle aches, headache, fatigue. EMS gave me double shot of... Read more
intense itching on back, neck, & scalp- muscle aches, headache, fatigue. EMS gave me double shot of Benadryl. via IV in right arm. I went home and slept for 3 hours. Woke up Right hand swollen and painful, muscle aches, headache, itching
47 2021-01-13 swelling Swelling right side of neck, shoulder, upper trapezius and tracheal area Slight rash Soreness in the... Read more
Swelling right side of neck, shoulder, upper trapezius and tracheal area Slight rash Soreness in the swollen areas
47 2021-01-14 lymph node pain, lymph node swelling enlarged tender post cervical LNs on the left side, the same side where vaccine given
47 2021-01-14 swelling The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I f... Read more
The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I felt tired and chilled, without fever. After the third day, symptoms subsided and I was back to normal activity. On the 7th day following the vaccine, I began having pain in the armpit of the left side. It was painful to have pressure on the area and to raise the arm overhead. It progressed on the the 8th day with increased pain and tenderness to touch. On the 9th day, I had severe pain with palpation and could feel a lump in the armpit. I have no redness, heat, or rash in the area. I went to my physician with concern because I have had a double mastectomy two years ago.
47 2021-01-15 lymph node swelling, lymph node pain Beginning 4 hours after second injection: body aches and chills that lasted 48 hours. These were not... Read more
Beginning 4 hours after second injection: body aches and chills that lasted 48 hours. These were not responsive to Tylenol or ibuprofen. On day two fever that got as high as 101 degrees was observed. Severe headaches lasted from 4 hours after second injection until 48 hours after second injection. Beginning at about 48 hours post second injection painful tender lymphadenopathy observed in axillary area of left arm. I am now 96 hours post second injection and the lymph nodes in that left arm are still swollen and tender and painful.
47 2021-01-15 peripheral swelling Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has s... Read more
Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has spread through shoulders and upper back; challenges in arms and legs?very little control, hard to even lift arm to eat, to type?like heavy weight pressing down on arms and shoulders, like filled with lead and extreme stiffness; still have floating feeling off and on; still have tingling in face, arms, and hands; dizziness; mental fog; headaches; heart palpitations; hands swelling--difficult to use. This has been ongoing for eleven days now. Other symptoms can be found in report made to Pfizer site: (1/12/2021 at 2:27 pm)
47 2021-01-16 lymph node swelling severe muscle, spine cord and joint pain, chills, lymphodenopathy started 12 hrs after 2nd vaccine d... Read more
severe muscle, spine cord and joint pain, chills, lymphodenopathy started 12 hrs after 2nd vaccine dose, extreme pain in right arm, leg, neck, and right side of the stomach started on day 2 - phone appointment with doctor , rash started on day 3 - urgent care visit, diagnosed with shingles after dermatology consult
47 2021-01-17 lymph node swelling Fever, chills, nausea, joint and muscle pain, axillary lymphadenopathy, headache, 2 days and count... Read more
Fever, chills, nausea, joint and muscle pain, axillary lymphadenopathy, headache, 2 days and counting
47 2021-01-17 swelling, swelling face I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my... Read more
I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my neck and back of my throat which began spreading to the back of my head . My heart felt as if I was startled by something. I looked at my smart watch and my heart rate was 145. I began trembling and having abdominal cramping . The back of my head felt like I had swelling or collection of fluid. I opened my windows and began taking slow deep breaths to bring down my heart rate . It took quite a while to get it below 100. I felt as if I was going to pass out. After deep breathing for what felt like atleasr 15 to 20 minutes , my pulse came down and I closed my windows . As soon as my body warmed back up in the car , the symptoms returned and my heart rate went back up to 130s , 140s . I had to keep my windows down and deep breathe the entire way home which took an hour . My body was trembling. When I got home I felt as if I was too week to get out of the car . I still felt that startled feeling in my heart and was afraid of what could happen next . My lips and face were swollen. My lips were also slightly itchy. I called 911 for help . By the time they arrived my vital signs had stabilized but I still had swelling in my face and lips . My EKG , vital signs and oxygen levels checked out normal so I did not go to the ER. That night I took benadryl and Tylenol. Day 2 post vaccine the collection of fluid or swelling in the back of my head had now spread to the top . That night I had the feeling that my throat was swelling do I took benadryl and Tylenol and my face and lips were still slightly swollen . Day 3 post vaccine I woke up with slightly blurry vision. The swelling in my head now feels like it has encompassed my entire head and have a slight headache. I went to the urgent care requesting an MRI of the head and an epi pen . I was given Medrol dose pack , an RX for epi pen for emergencies and advised to continue benadryl and Tylenol. Day 4 post vaccine, slight headache continues. Slightly blurry vision
47 2021-01-18 lymph node swelling Lymph node on the side of the injection, behind ear at base of head swelled about 1.5 hours after in... Read more
Lymph node on the side of the injection, behind ear at base of head swelled about 1.5 hours after injection swelled. within a few hours unable to turn head without pain. From base of head to back was so sore and for 24 hours hard to turn head..
47 2021-01-18 peripheral swelling, swelling face Face flushed like a sunburn and sweating a lot since about 17 min after. Pain in left eye down to mi... Read more
Face flushed like a sunburn and sweating a lot since about 17 min after. Pain in left eye down to mid cheek and full face mild puffiness. Difficulty swallowing only for 5 min then sore throat since then. Nausea starting about 2 hours after. Left arm swelling and a lot of pain for a couple hours in the middle of the night and still very sore but better. Woke up with both eyes bloodshot. Feeling like my scalp was hot and tight for about a half hour but that went away.
47 2021-01-20 herpes virus infection I experienced an active herpes outbreak. While I cannot conclusively state the vaccine caused the o... Read more
I experienced an active herpes outbreak. While I cannot conclusively state the vaccine caused the outbreak I can report that I have not experienced an outbreak in approximately 20 years.
47 2021-01-20 lymph node swelling Swollen painful lymph nodes (3) left axillary, tylenol/ibuprofen
47 2021-01-20 lymph node swelling she had left arm pain as well; she is very sweaty now; had a migraine yesterday; she had achy joints... Read more
she had left arm pain as well; she is very sweaty now; had a migraine yesterday; she had achy joints all over yesterday; had achy joints all over yesterday, saying her neck hurt; felt sick with a runny nose; felt sick with a runny nose; the gland in her armpit (clarified as left armpit) area is swollen and very painful; the gland in her armpit (clarified as left armpit) area is swollen and very painful; hard time sleeping.; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231, expiration date 30Apr2021), via an unspecified route of administration on 09Jan2021 11:50 at single dose (left arm) for COVID-19 immunization. Medical history included penicillin rash. There were no concomitant medications. The patient previously took diflucan 15 years ago and experienced extreme allergic reaction to diflucan; and amoxicillin and experienced rash. She stated she had a rash in the past to Amoxicillin and Penicillin. She received the COVID-19 vaccine on Saturday (09Jan2021), and the gland in her armpit (clarified as left armpit) area was swollen and very painful. She said she took Tylenol, and the Tylenol cut the pain. She stated she still has a little pain today. Her left armpit started feeling uncomfortable on Saturday night, and she had a hard time sleeping. She said when she woke up on Sunday morning, 10Jan2021, her left armpit area was extremely painful, clarifying she had left arm pain as well. She said the pain in her left arm has lessened today, but her left armpit area was still painful. Clarified she took a repeated 3 Tylenol 200 mg (600mg) dose over the past couple days for her left armpit pain. She took her first dose of 3 Tylenol 200mg tablets (600mg dose) at noon on Saturday, 09Jan2021, and another 3 Tylenol 200mg (600mg dose) at 5:00PM on Saturday evening and went to sleep. She said she woke up after her nap on Saturday evening, and was sweaty and had left armpit pain. She said she took another 3 Tylenol 200mg tablets (600mg dose) on Sunday, 10Jan2021, at 5:00PM. She said she took her last dose of 3 Tylenol 200mg tablets (600mg dose) this morning, 11Jan2021, at 7:00AM. On Saturday night, 09Jan2021, it was only her left armpit that was sore, but by Sunday, 10Jan2021 morning, her whole left arm was in pain and the gland in her left armpit was swollen. On 10Jan2021, the patient was very sweaty, and had a migraine. Clarified she felt sweaty now, like she just woke up from a fever. She said she was not overdressed, but maybe she was in a hot environment. She said she had no fever when she checked her temperature. She also had achy joints all over and her neck hurt on 10Jan2021. Patient reported that she had a PPD skin test administered 2 months ago and had no reaction to the PPD skin test. She felt sick with a runny nose on 10Jan2021, but she felt fine today, 11Jan2021. She said that after she received the COVID-19 vaccine, it was less than 24 hours when everything started happening. The patient had no history of all previous immunization with the Pfizer vaccine and no vaccines administered on the same date of the vaccine. The patient had no prior vaccinations within 4 weeks. Outcome of event hard time sleeping was unknown; she had left arm pain as well, had achy joints all over yesterday, saying her neck hurt, felt sick with a runny nose, was recovering; had a migraine yesterday was recovered on an unspecified date; and outcome of the rest of events was not recovered.
47 2021-01-20 swelling, swelling face 10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and f... Read more
10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and flushed and experienced mild difficulty breathing. A rapid response was called, patient noted to have a swollen and red face and neck. 0.3mg IM Epinephrin given. HR 108, SpO2 98% on room air. Patient taken to the emergency department for follow-up. In the ED patient reported feeling anxious, nauseous, and having a dry mouth. Notes that she had never had a reaction to a vaccine before. Diagnosed with an allergic reaction to the COVID-19 vaccine. Benadryl, pepcid, and Solumedrol given.
47 2021-01-21 axillary mass DOLOR EN AMBOS AXILAS Y EL CUERPO. PRESENTA HEMATOMAS EN AREA DE AXILAS EN AMBOS BRAZOS.
47 2021-01-21 lymph node swelling On 1/21/2021 I woke up and felt a large lump by on left clavicle. It was about 1.5inch, tender, war... Read more
On 1/21/2021 I woke up and felt a large lump by on left clavicle. It was about 1.5inch, tender, warm, smooth. I also had increased used of my albuterol inhaler due to shortness of breath. I went to the doctors. The started me on spariva and did a chest X-ray. They felt the lump was a swollen lymph node and to come back in two weeks if it remains swollen.
47 2021-01-21 lymph node swelling 48 hours after vaccine developed Left axillary lymph node swelling and pain. Currently taking alleve... Read more
48 hours after vaccine developed Left axillary lymph node swelling and pain. Currently taking alleve for pain.
47 2021-01-21 swelling, lymph node swelling vaccine was given at 6:40am and by midnight I had headache, chills and fever. By 7 am I had severe j... Read more
vaccine was given at 6:40am and by midnight I had headache, chills and fever. By 7 am I had severe joint pain, muscle aches and my left arm pit was painful, swollen lymph node in my left arm pit and left neck. Fever and joint pain were gone by sunday. Then on monday night I came down with a bad chest cold, runny nose and cough and chills but no fever. Chest cold symptoms still present today 1/22/21.
47 2021-01-24 lymph node swelling Extreme body aches, swollen axillary lymph nodes of side of vaccine
47 2021-01-24 lymph node swelling Had pain underneath arm; Then whole lymph nodes were swollen up until her armpit; This is a spontane... Read more
Had pain underneath arm; Then whole lymph nodes were swollen up until her armpit; This is a spontaneous report from a contactable Other-HCP (patient). A 47-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at SINGLE DOSE for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced side effects after she got her 1st dose last 24Dec2020. On 26Dec2020, she had pain underneath arm and then whole lymph nodes were swollen up until her armpit 2 days after receiving the vaccine. Her 2nd dose is scheduled this Thursday and wants to know if she should get it. The outcome of the events was unknown. Information about lot/batch number has been requested.
47 2021-01-24 lymph node swelling Soreness and swelling of underarm.
47 2021-01-24 peripheral swelling Fever Body Aches left underarm pain, and swollen
47 2021-01-24 peripheral swelling Headache, joint ache, fever, left deltoid swelling and left underarm/armpit swelling (size of half o... Read more
Headache, joint ache, fever, left deltoid swelling and left underarm/armpit swelling (size of half of a tennis ball)
47 2021-01-24 swelling face Intense pruritic episode 4 hours post vaccine. Slight swelling in face. Lasted approx 24 hours per p... Read more
Intense pruritic episode 4 hours post vaccine. Slight swelling in face. Lasted approx 24 hours per patient.
47 2021-01-24 swelling face Swollen face, eye lids , area below eyes and redness in eyes Water eyes, congested nose, slight head... Read more
Swollen face, eye lids , area below eyes and redness in eyes Water eyes, congested nose, slight headache
47 2021-01-25 peripheral swelling, swelling, lymph node swelling Temperature 100.5-102. Swelling of all Lymph nods throughout entire body within 48 hours. EXTREME pa... Read more
Temperature 100.5-102. Swelling of all Lymph nods throughout entire body within 48 hours. EXTREME pain with swelling. 72 hours into time left side of body was swollen to point that clothing and jewelry do not fit. Left under arm and Breast are extra swollen *approximately triple size of right side. Migraine at 30 hours. Stomach pain in right side at 28 hours, also nausea and diarrhea.
47 2021-01-26 anaphylactic reaction Systemic: Anaphylaxis-Severe
47 2021-01-26 lymph node swelling When I got my first half of vaccine I did have a swollen lymph node along my collar bone on the left... Read more
When I got my first half of vaccine I did have a swollen lymph node along my collar bone on the left side; This is a spontaneous report from a contactable nurse. This 47-year-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: EK5730) at single dose in the left upper arm for vaccination on 21Dec2020. Relevant history included Hypertension. Relevant concomitant drug included Lisinopril 10 mg daily for blood pressure, Omeprazole 20 mg daily, Vitamin Supplements. The nurse stated, " When I got my first dose of vaccine I did have a swollen lymph node along my collar bone on the left side which is on the side where I got the shot and it didn't really change much. It just kind of stayed the same size and it remained there for whole three weeks. This small one along my collar bone that started right after the first vaccine and that has stayed the whole time. But got bigger after my second." No treatment was received. The outcome of event was not resolved. The patient believed the swollen lymph nodes were due to the Covid 19 Vaccine.
47 2021-01-26 lymph node swelling Approximately baseball-sized area of left axillary lymphedema. Edema and subsequent pain was first ... Read more
Approximately baseball-sized area of left axillary lymphedema. Edema and subsequent pain was first noticed just under 24 hours after vaccine dose and was completely resolved by the 5th day following the vaccination.
47 2021-01-27 lymph node swelling Swollen lymph nodes in left armpit and left neck. Ringing and pain in ears. Ear pain started 2 hours... Read more
Swollen lymph nodes in left armpit and left neck. Ringing and pain in ears. Ear pain started 2 hours after vaccine. Swollen and painful armpit node started 1 day after vaccine.
47 2021-01-27 swollen extremities Immediately following shot my blood pressure drop felt like I was going to faint. With in a couple h... Read more
Immediately following shot my blood pressure drop felt like I was going to faint. With in a couple hours sore arm at injection site. With in 12 hours headache, slight fever achy body. 24 hours in my arm pit on the same Injection arm was swollen and uncomfortable and has remained so for 4 days so far.
47 2021-01-28 lymph node swelling, lymph node pain Left arm pain and stiff; left clavicular lymph node swollen and painful; temp max 101; malaise, decr... Read more
Left arm pain and stiff; left clavicular lymph node swollen and painful; temp max 101; malaise, decrease appetite; loose bowel movement.
47 2021-01-31 peripheral swelling Onset of headache during wait time. 2130 chills, feverish, headache, rash. 0230 rash, itchy throat, ... Read more
Onset of headache during wait time. 2130 chills, feverish, headache, rash. 0230 rash, itchy throat, flush, feverish, chills 1/23/21 headache, irritated throat, chills, feverish, rash, night sweats, swelling hands and feet, fatigue 1/24/21 itchy throat, rash, headache, chills, feverish, flush, swelling hands and feet 1/25/21 rash, irritated throat, headache, chills, feverish 1/26/21 mild rash, headache, chills, feverish 1/27/21 chills, feverish, mild rash 1/28/21 itchy throat, flushed, itchy, rash on entire body, feverish 1/29/21 mild rash, chills. 1/30/21 flushed and itchy, itchy throat, chills, feverish
47 2021-01-31 swelling face I developed a lump under my cheeck and some facial swelling.
47 2021-01-31 swelling face Individual developed a severe headache followed by a bloody nose post-vaccination with second dose. ... Read more
Individual developed a severe headache followed by a bloody nose post-vaccination with second dose. Individual reports continuing intermittent headaches followed by a bloody nose. She is to follow up with an ENT specialist. Patient also experiencing eye droop of right-side along with facial swelling of that side.
47 2021-02-01 lymph node swelling 12/28 Vaccine 6:30 AM. 2 hours later rash appeared @ injection site and 3" around in diameter. Aroun... Read more
12/28 Vaccine 6:30 AM. 2 hours later rash appeared @ injection site and 3" around in diameter. Around 8 hours after, I felt SOB and rash spread to all extremities. I took hydrosteroids; prednisode and benadryl. The rash started to get better about 4 hours later. 12/29 Body aches, fatigue. Swollen lymphnodes for at least 5-6 days. History of Severe allergies; eggs, shellfish, sulfa, etc. (listed on first page). Carry epi pen 24/7. Have not had Anaphylaxis reaction for 4 years. *premedicated with benadryl before 2nd vaccine. No rash. but still had body aches.
47 2021-02-02 anaphylactic reaction Systemic: Anaphylaxis-Severe
47 2021-02-02 oral herpes fever, chills, headache from 12 hours post-vaccination through 36 hours. Full recovery after with sl... Read more
fever, chills, headache from 12 hours post-vaccination through 36 hours. Full recovery after with slight lingering headache and cold sore.
47 2021-02-03 lymph node pain, lymph node swelling Severe headache for 24 hours and off and on for a few days along with fatigue. Lymph nodes under ri... Read more
Severe headache for 24 hours and off and on for a few days along with fatigue. Lymph nodes under right arm swelled up 2 days after injection and remained swollen and painful for several day.
47 2021-02-03 lymph node swelling swollen supraclavicular lymph nodes/axillary lymph node swelling; first dose of BNT162B2; on 26Dec20... Read more
swollen supraclavicular lymph nodes/axillary lymph node swelling; first dose of BNT162B2; on 26Dec2020 11:00 AM/second dose of BNT162B2; on 14Jan2021 11:00 AM; This is a spontaneous report from a contactable Nurse (patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular at the left arm on 14Jan2021 11:00 AM at single dose for Covid-19 immunization in a hospital. Medical history was not reported. The patient has no COVID prior vaccination. The patient was not pregnant. Concomitant medications was none. The patient previously took vancomycin and experienced allergies. Historical vaccine included first dose of BNT162B2 intramuscular at the left arm on 26Dec2020 11:00 AM at single dose for Covid-19 immunization. The patient has no other vaccine in four weeks. On 15Jan2021 11:00 AM, the patient experienced swollen supraclavicular lymph nodes approximately 24 hours after 2nd shot, some very minor axillary lymph node swelling both on left side, shot arm. The event resulted in doctor or other healthcare professional office/clinic visit. The patient was not COVID tested post vaccination. The patient did not receive treatment due to the event. The event swollen supraclavicular lymph nodes/axillary lymph node swelling was recovering. Follow-up activities are possible, information on the batch number has been requested.
47 2021-02-03 lymph node swelling Nausea, body aches, chills, swollen glands, sore arm.
47 2021-02-03 peripheral swelling Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with ... Read more
Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with severe ocular pressure; palpitations; dizziness; Tingling and numbness to hands and feet; Tingling and numbness to hands and feet; Vein engorgement and swelling of left leg; Vein engorgement and swelling of left leg; right abdominal and flank pain; right abdominal and flank pain; crushing headache with severe ocular pressure; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 47-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: El3249), via an unspecified route of administration in the left arm on 19Jan2021 at 15:30 as a single dose, for COVID-19 vaccination. The vaccine was administered in a Nursing Home/Senior Living Facility. Medical history included asthma and known allergies (details not provided). Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 at 15:30, the patient experienced Profound weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure. The events resulted in an emergency room visit and physician office visit. No treatment was given for the events. The clinical outcome of weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
47 2021-02-03 peripheral swelling Employee began complaining about a "cold feeling" in her rt arm followed by numbness and "pins and ... Read more
Employee began complaining about a "cold feeling" in her rt arm followed by numbness and "pins and needles" like sensation. She also complained that her rt arm was feeling swollen and red. Mild redness noted upon assessment but no obvious swelling visually. Observed employee for 30 minutes after vaccine and symptoms persisted. Employee has a history of severe reactions to food and medications. Vital signs obtained and BP noted to be in 150s/90s, Hr in 90's, temperature and oxygen saturation were both within normal limits. Employee denied any feeling of swelling of face or throat, but was taken to emergency department onsite for further evaluation as her numbness continued to persist past 30 minutes observation. Employee reported that she was triaged only and was in lobby for about 2.5 hours after which time she left since she felt her symptoms were improved. She called her PCP when she arrived home and was instructed to take 25 mg of Benadryl orally. Employee reported that her symptoms completely resolved after that and that she had no subsequent symptoms.
47 2021-02-03 swelling Starting at about 10 hrs last injection through 36hrs ran a low grade fever, chills, body aches, exh... Read more
Starting at about 10 hrs last injection through 36hrs ran a low grade fever, chills, body aches, exhaustion. At around hour 36 I noticed my right armpit hurting and visibly swollen
47 2021-02-05 lymph node swelling Axillary lymph node under right arm swollen to the size of a cue ball
47 2021-02-05 lymph node swelling REACTIVE LYMPH NODE SUPRACLAVICULAR
47 2021-02-05 swollen extremities, peripheral swelling 12 hours after second injection, localized swelling and edema of right arm and shoulder extending to... Read more
12 hours after second injection, localized swelling and edema of right arm and shoulder extending to right ribcage. Fourteen hours post-injection (2nd dose only)Fever of 103.5, myalgia, chills, stiff neck, sheadache, and significant sharp pain in joints, muscle cramping in legs and arms. After treating with 600 mg ibuprofren, fever was reduced to 101.0. Fever recurred four hours later with profuse sweating. 600 mg of ibuprofren taken which again reduced fever to 99.8. At 24 hours post injection, swelling of ribcage and shoulder is subsiding, fever of 99.9. Having survived septic shock in 2011, I can say this felt the same. It was extremely painful.
47 2021-02-06 anaphylactic reaction 2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing w... Read more
2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing with chest tightening, heart racing, numbness and tingling on my mouth and chin, tongue swollen and turned grey in a matter of a few minutes. I took Benadryl, an epinephrine pen, and a nebulizer and began to start feeling better in 15 minutes. Following the 2 weeks I felt nauseous, chills, cold sweat, lightheaded, weak, tired, headache and pain in arm/shoulder.
47 2021-02-07 swollen extremities Initial symptoms were sore throat and nausea the evening of the vaccination (Wednesday, 2/3/21). Th... Read more
Initial symptoms were sore throat and nausea the evening of the vaccination (Wednesday, 2/3/21). Those continued the following day and as the day progressed I also was experiencing a headache, mild achiness, left side of my neck was sore/tender, and then that evening chills and a fever of 101.3. On Friday, 2/5/21 I woke up with a very sore and swollen right axilla and still had a headache, but the fever resolved over night. All symptoms, except right axillary swelling/soreness was resolved by the afternoon on 2/6/21. Currently, on 2/8/21, I still have mild tenderness/soreness in right axilla.
47 2021-02-09 lymph node swelling Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the tas... Read more
Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the taste and smell; Weird taste in her mouth; Headache; Swelling in her throat; Injection site pain; Muscle pain; Injection site swelling and redness; Injection site swelling and redness; Swollen lymph node; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, on 24Jan2021 at a single dose for COVID-19 immunization. Medical history included asthma from an unknown date. Concomitant medications were not reported. It was reported that the patient got the COVID-19 vaccine shot on 24Jan2021. When she sat there for 15 minutes, she got a weird taste in her mouth and got a headache. At 2 PM she still had a headache and she lost most of the taste and smell; at 4 pm she was sick to her stomach; by 5:15, her arm and head hurt badly, the taste in her mouth was like super weird but it was not exactly metallic taste it was weird bizarre taste she never had before. Her smell came back. She was extremely nauseated and had a bad headache. She stated that all of her symptoms were gone away except the swelling in her throat. She further stated she called the hospital and stated she got injection site pain, headache, and muscle pain. She also got injection site swelling and redness, nausea, swollen lymph node and a headache and the weirdest part that really bothered her was the strange taste in her mouth. She got some of the smell and taste back and now it's gone; it's really bizarre like the injection site pain, the headache everything was gone literally gone. The only things that was still hanging on was her lymph nodes and throat. The second due dose of vaccine was on 14Feb2021. The patient has not recovered from swelling in her throat and swollen lymph node, and has recovered from other events. Information on the lot/batch number has been requested.
47 2021-02-09 lymph node swelling Chill; fever; body aches; migraine; dizziness; soreness at injection site; headache; lymph node swol... Read more
Chill; fever; body aches; migraine; dizziness; soreness at injection site; headache; lymph node swollen on left arm pit area; This is a spontaneous report from a contactable other healthcare professional(patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3302), intramuscularly into the left arm on 23Jan2021 11:45 at a single dose for covid-19 immunisation. Medical history was reported as none. Patient was not pregnant. Concomitant medication included escitalopram oxalate (LEXAPRO), riboflavin (RIBOFLAVIN), multivitamins and antihistamine (unspecified). The patient was previously administered with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El0140), intramuscularly into the left arm on 02Jan2021 12:30 at a single dose for covid-19 immunization. On 23Jan2021 20:30, patient experienced chill, fever, body aches, migraine and dizziness. On 23Jan2021, patient experienced soreness at injection site, headache and lymph node swollen on the left armpit area. The patient did not receive treatment for the events reported. Outcome of events were recovering.
47 2021-02-10 swelling Angioedema the following morning [ my lips were swollen +3] . No treatment sought .
47 2021-02-10 swelling, swelling face her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; f... Read more
her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; fever; her right carotid on her neck felt swollen; right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt; tired and achy; tired and achy; feeling sick; muscle and joint pain; muscle and joint pain; cough; the back of her ribs hurt; Nausea; she is having shooting pains in different spots; This is a spontaneous report from a contactable nurse reporting for self. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number EL3249, via an unspecified route of administration from 25Jan2021 14:00 (at the age of 47 years old), Dose 2, as a single dose in the left arm for COVID-19 immunization. Medical history included she had her tonsils out on an unknown date. She was a nurse that works with COVID patients; she got tested twice last week (Jan2021), both were negative. She had no pre-existing medical conditions. She has never had a problem with vaccines. There were no concomitant medications. The patient previously received dose 1 of BNT162B2 on 04Jan2021 (Lot # EX9231) and experienced no reaction then. The patient had the second dose of the Pfizer vaccine around 2 PM yesterday (25Jan2021) and she kept moving around in bed and feeling sick last night. That night she was just tired and achy but she thought that could just be from working. She went to bed early and she woke up around 1:50 or 2 AM with chills so she went and got a thermometer. She woke up at about 2 AM (26Jan2021) with a 103 fever and chills and her right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt. Her skin just burns; she went to take a shower. With the skin burning she knew it was sore to touch but when she got in the shower, that was when she noticed it hurt. She was really achy; her legs were aching and she was having shooting pains in different spots. She commented that she called out today (26Jan2021), she never calls out; all she wanted to do was take a shower and she wondered if she needed to go to the doctor. Her skin burns even when she was showering; every part her skin burns. She was also having muscle and joint pain and cough and the back of her ribs hurt (Jan2021). The other thing was nausea (Jan2021). The fever and chills were persisting and were about the same. She was hoping for it to go down so she could go to work to tomorrow (27Jan2021). The clinical outcome of the fever, chills, and her right carotid on her neck felt swollen and hurt was not recovered. The clinical outcome of feeling sick, tired and achy, face feels swollen, skin burning, muscle and joint pain, cough, back of her ribs hurt, nausea, and shooting pains in different spots was unknown. The reporter states she thinks what she is reporting was directly related to the product.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
47 2021-02-13 lymph node swelling After very little reaction on the day of besides some weakness and fatigue. The next evening I devel... Read more
After very little reaction on the day of besides some weakness and fatigue. The next evening I developed a swollen supraclavicular lymph node on the right side (same side as injection site) It became hard and painful.
47 2021-02-14 lymph node pain, lymph node swelling Swollen lymph node near the collar bone on the left side. Tender to the touch
47 2021-02-14 lymph node inflammation, lymph node swelling Severe enlarged lymph node, resolved in about a week, large lump in armpit that was super sore and h... Read more
Severe enlarged lymph node, resolved in about a week, large lump in armpit that was super sore and hurt to the touch. Right arm pit.
47 2021-02-14 lymph node swelling, lymph node pain lymph node swelling/pain beginning in my neck with neck pain. Progressively spreading until 2/14, l... Read more
lymph node swelling/pain beginning in my neck with neck pain. Progressively spreading until 2/14, large lump in breast, red streaks. Pain in groin and shoulder, all on left side.
47 2021-02-14 lymph node swelling syncopal episode; Swollen lymph nodes in left neck and left arm pit; Nausea within a couple of hours... Read more
syncopal episode; Swollen lymph nodes in left neck and left arm pit; Nausea within a couple of hours of vaccine /continued nausea; Fatigue; fever; chills; headache; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 47-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283), via an unspecified route of administration in left arm on 27Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included very infrequent anxiety and headaches, only after illness. Concomitant medication included sertraline, ethinylestradiol, norethisterone acetate (JUNEL), fluticasone propionate (FLONASE). The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies to Compazine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), via an unspecified route of administration at the age of 47-year-old in left arm on 06Jan2021 10:30 at single dose for COVID-19 immunization. The patient experienced nausea within a couple of hours of vaccine. The patient experienced fatigue, fever, chills, headache, continued nausea, dizziness with 1x syncopal episode, swollen lymph nodes in left neck and left arm pit, mostly resolved after 3 days. She had still with headache. All events occurred on 27Jan2021 14:30. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The patient did not receive any other vaccines in four weeks. The patient was no pregnant. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the event headache was not recovered and the outcome of the other events was recovering.; Sender's Comments: Based on a compatible temporal relationship causality between event syncopal episode and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
47 2021-02-15 swollen extremities, swelling face With the first dose I felt sick for 1 day. I called out. The morning after receiving the 2nd dose ... Read more
With the first dose I felt sick for 1 day. I called out. The morning after receiving the 2nd dose I had severe fatigue, joint pain, my wrist and my armpit was budging, I noticed swelling my clavicle on my left side, chills, and dizzy. I had to miss work for 2 days. I had to lay bed in for 2 days. By 3rd it was much improved but I still feel weak. About 4 days after receiving the vaccine I was back to feeling my self. On 2/14-15/2021, my face was itching, I scratched it, and there is a small abrasion. My face started to swell, around 2AM this morning I had to go to the ER because my eyes were getting small, the swelling was getting worse. I also had bumps that looked like hives on my face, there was some fluid coming out of my face. I went to early this morning, The ER doctor said she thinks it is not infected she thinks it is inflamed. I did not mention that I had recently received the COVID vaccine and did not realize that it may be linked to the vaccine until later in the day. She prescribed Hydrocortisone 0.5 % cream and Mupirocin 2% cream. Since I have been home the ER the swelling has worsened. My face is painful, it feels like an orange peel when you touch.
47 2021-02-16 lymph node pain, lymph node swelling Tenderness under right arm began on Fri. Feb. 12. The next day, the pain had increased enough that I... Read more
Tenderness under right arm began on Fri. Feb. 12. The next day, the pain had increased enough that I looked in the mirror, to find a moderately large swelling. It increased in size overnight Sat. Feb. 13. Sunday, the swelling reduced a bit, to the same size I found it originally. It has remained that size - a decent golf ball - since then, Sun. Feb., 13. Though localized tenderness in lymph nodes has decreased quite a bit, I'm now in a significant Fibromyalgia flare (which could also be explained by a change in weather).
47 2021-02-17 lymph node swelling, swelling face My lymph node in my neck swelled to the point it stuck out like a robin egg; sores in mouth (roof, g... Read more
My lymph node in my neck swelled to the point it stuck out like a robin egg; sores in mouth (roof, gums, and inside lips); sores in nostril; sores on nose and lips; sores on nose and lips; Face swelled significantly on my left side; pink eye; severe headache; sinus pain; jaw main and numbness in my molars; severe shooting nerve pain in my front teeth; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 23Jan2021 18:45 at a single dose for covid-19 immunization. Medical history included breast cancer survivor as of 11Sep2019. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), clonazepam, anastrozole (ARIMIDEX), vitamin D3, calcium, vitamins NOS (MULTIVITAMIN), "It Works" and "Fat Fighter". The patient previously took fentanyl but had allergies. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her lymph node in her neck swelled to the point it stuck out like a robin egg. It was mentioned that it was more swelled there as well and super sensitive to touch. These reactions occurred only on left side of her face, sores in mouth (roof, gums, and inside lips) and sores in nostril. She had sores on nose and lips. The patient mentioned that her face swelled significantly on her left side. She had pink eye, severe headache, sinus pain, jaw main and numbness in her molars, severe shooting nerve pain in her front teeth. The events were considered as non-serious and adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since vaccination. The events required treatment for the adverse events that included Keflex, Bactroban, prednisone, Valtrex, and lidocaine viscous-aluminum &magnesium hydrAM. The outcome of the events was recovering.
47 2021-02-17 lymph node swelling Left axillary lymph node swollen . Sleep paralysis. Tired. Dizzy, hungry thirsty.
47 2021-02-17 peripheral swelling I experienced a rash in my face. It looked like mosquito bites almost. The normal pain on the inject... Read more
I experienced a rash in my face. It looked like mosquito bites almost. The normal pain on the injection - red on outside. Whole arm was red and swollen. That lasted several days. Next day after vaccine, Inside of my arm, I noticed rash (looked like chicken pox/mosquito bites) and then it went to chest, abdomen and legs. The rash continued. My face was flushed and had a 99.9 fever. I had foggy brain and chest pain (started day after the vaccine). The chest pain would last about a minute - I monitored my heart rate. From sitting down my heart rate when up to 120 and down to 37. This occurred for four days - four - six times a day. By the 3rd day after vaccine, I started feeling worse. I experienced dizziness, nausea, couldn't think, was disorientated, rash on my body, no appetite, couldn't sleep well and had no energy and chest pain - was in bed for next three days. I didn't call my Dr right away, I was monitoring the chest pain while I rested. That resolved (chest pains) by Saturday. The rest continued. My Monday, I called Public Health and they advised to call my DR. Spoke to Dr. on 11th. On the 12th, I had a telehealth appt with him. On the 13th had an EKG done. Everything normal on EKG. I continued feeling dizzy and no energy. I didn't work until Jan 19th. On the 20th, I felt foggy brain and rash wasn't gone and I went back to my doctor on January 21 and he put me off work for another week. At this point, within the last few days, my energy is back and rash is gone - I do still have dark spots on back and legs from the rash. On January 25th, I got the second dose. (The rash kind of flared back after second dose but nothing as bad.)
47 2021-02-18 swelling After the first injection, I got a upper chest rash but did not relate this to the vaccine. After 4... Read more
After the first injection, I got a upper chest rash but did not relate this to the vaccine. After 48 hours of the second injection on 1/8/2021, I had angioedema facial swelling on the lids of my eyes bilaterally, facial burning- lips, nose, and right side of face, as well as the upper chest rash. Tried cool compresses, ibuprofen and rest however did not go away. Went to employee health, threw away all my make up incase, prednisone taper and antihistamine QD, eat clean, lots of water. The swelling went away after a few days of cool compresses and when on 10 mg of the prednisone taper, it came back. Went to PCP this time and gave me dexamethasone injection, prednisone taper, antihistamine BID and continue all other o
47 2021-02-18 lymph node swelling Symptoms: Headache, Nausea, Fever, Aches, Chills, Ear pain, Swollen glands, Fatigue
47 2021-02-18 oral herpes Injection site soreness developed 5 hours later. Body aches, headache and fever noted upon waking 15... Read more
Injection site soreness developed 5 hours later. Body aches, headache and fever noted upon waking 15 hours later on Saturday morning. Highest fever 101.2. Symptoms lasted approximately 13 hours. Sunday morning woke feeling fine. On Monday morning I felt a tingle on my lip. By mid-day there were vesicles and by evening an apparent cold sore forming on right upper lip. Large cold sore still present 5 days later.
47 2021-02-19 swelling face my face swollen and painful
47 2021-02-22 swollen extremities Swelling underneath arm pit. doctor advised Tylenol and warm compress
47 2021-02-22 swelling face Itchy and bumpy face started on February 17th. Woke up on the 18th with a swollen face and continue... Read more
Itchy and bumpy face started on February 17th. Woke up on the 18th with a swollen face and continued with bumps and itchiness. Went to Urgent Care on February 20th and started steroids. The swelling increases while I am sleeping.
47 2021-02-23 lymph node swelling Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelli... Read more
Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelling and pain of injection site; Swelling and pain of injection site; Fever; Chills; 3 by 5 inch red circle and swelling around injection site/arm turned red; This is a spontaneous report from a contactable other healthcare professional (medical receptionist -patient). A 47-years-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EL3246, expiration date unknown), via an unspecified route of administration on the left arm on 20Jan2021 at 17:30 at the age of 47 years old at a single dose for COVID- 19 immunisation in the hospital. Medical history included mitral valve prolapse, gallstones , hypertension and crab allergy. Concomitant medications included lisinopril and hydrochlorothiazide. The patient did not receive vaccines in four weeks. On 28Jan2021 at 07:00 AM, the patient had a little bit of arm soreness initially. The patient experienced swollen lymph nodes under arm, swelling and pain of injection site, fever and chills. On the 9th day after vaccine (29Jan2021), patient had a 3 by 5 inch red circle and swelling around injection site. It was also reported that the arm and lymph nodes swelled. The patient had fever and chills. Then her arm turned red. As of 05Feb2021, the swollen mark which is about 5x4 inches is swelling again. The patient's next dose is scheduled for 10Feb2021. She is really concerned about getting the second dose. The events were assessed as non-serious by the reporter. It was unknown if the patient received a treatment in response to the events. The patient was not diagnosed with COVID-19 prior t vaccination and was not tested for COVID-19 post vaccination. The outcome of the event was unknown.
47 2021-02-28 lymph node swelling After my first vaccine, I developed an axillary lymph node to my left arm which was painful; it felt... Read more
After my first vaccine, I developed an axillary lymph node to my left arm which was painful; it felt like it was ripping out of my left arm and it was tender. The lymph node subsided after two days of the vaccination. I also had two menstrual cycles back to back which was out of the ordinary for me since I am regular on my periods. I saw my gynecologist due to my menstrual symptoms. I was regular up to that point of my vaccination. One week ago I had better range of motion to my left arm.
47 2021-02-28 lymphatic obstruction Lymphadema in neck, armpit and breast
47 2021-03-01 lymph node swelling, lymph node pain Right groin lymph nodes swollen and painful.
47 2021-03-01 lymph node swelling Swollen lymph node left arm; This is a spontaneous report from a contactable Other Health Care Profe... Read more
Swollen lymph node left arm; This is a spontaneous report from a contactable Other Health Care Professional, the patient. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number El3264), intramuscularly on 28Jan2021 at 15:45 (at the age of 47-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included asthma from an unknown date and unknown if ongoing. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number El1284), on 07Jan2021at 16:40 in the left arm for COVID-19 immunization. The paktient has unspecified allergies to Penicillin. The patient previously too clindamycin (UNKNOWN MANUFACTURER) and experienced an unspecified allergy.The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Concomitant medications were not provided. On 28Jan2021 at 19:15, the patient experienced a swollen lymph node in the left arm. The patient did not receive any treatment for the event. The clinical outcome of swollen lymph node was reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
47 2021-03-02 lymph node swelling I had my 2nd dose of Phizer Covid Vaccine on February 19, 2021 and had it in my left arm. My first ... Read more
I had my 2nd dose of Phizer Covid Vaccine on February 19, 2021 and had it in my left arm. My first dose 3 weeks prior was in my right arm. I did not experience any side effects from the shot for 4 days. I woke up on Tuesday, February 23rd and had pain in my right arm - the arm I had the 1st shot in, not the 2nd! I continued to have pain in my right arm for several days and then 6 days after my 2nd dose I started having extreme pain in my legs - from my knees up the back of my thighs for two days. Then 8 days after my 2nd dose my other arm became very sore, the arm I had the 2nd dose in. So both arms are sore and the lymph nodes under the arms are tender. Today I am 11 days out since my 2nd dose and I woke up and could barely lift my left arm. I have pain in both arms and lymph nodes. I went to my family doctor and he does not have any answers for me. I need to know if this is something I should be concerned about and if there is anything I can do to help these side effects go away. How long can this last???
47 2021-03-03 anaphylactic reaction Injection given at 0917 and at 0925 she was coughing and felt someone wrong with her breathing and h... Read more
Injection given at 0917 and at 0925 she was coughing and felt someone wrong with her breathing and had increasing mucous. Pt stated this is how she feels when she has an anaphylactic reaction. HR was 122 and B/P 155/93. Benadryl 50 mg given at 0930, and epi given at 1001. Solumedrol at 1032 O2 99% at 1034. ACLS transfer to ER.
47 2021-03-04 lymph node swelling Nursing Notes: Employee had second shot on Feb 23rd. Initially only had soreness and inflamed lymphn... Read more
Nursing Notes: Employee had second shot on Feb 23rd. Initially only had soreness and inflamed lymphnodes, general malaise. By Friday night, developed a hive below her lips and her left arm was 'itching" severely. Took benadryl again. Didn't have problems Sunday night. Today arm started itching a lot throughout the day. About 45 minutes ago, experienced redness and hives again, a 1 inch by 4inch welt. Pt also states she has multiple conditions that have cause allergic reactions. Son has Mast Cell Activation symptom Disposition: ER. Concern for allergic reaction.
47 2021-03-04 swelling face The entire left side of my body immediately felt mildly heavy and affected, but it was so minimal I ... Read more
The entire left side of my body immediately felt mildly heavy and affected, but it was so minimal I thought it could be in my head. Throughout the evening after my shot I felt a bit of contracting of leg muscles and neck/shoulder muscles on the left side of my body. The left side of my face felt noticeably warmer than the right. This was all very mild, but just noticeable. In the middle of the night, I woke up with extreme night sweats but only on the left side of my body. The next morning (today) the left side of my face is still warmer but it feels droopy and bloated and slightly "Numbish". My left eyelid feels heavy. My left cheeks feel swollen and puffy and my left gums and lips feel slightly numb. I also have a very mild headache only on the left side. This is disturbing, while it is not debilitating or painful, it is strange and makes me think I should not get the next shot. Even as I type this, my left hand feels very fatigued. I don't know who to call or talk to about this. I do not have a health care provider.
47 2021-03-04 swelling Severe headache; lightheadedness; weakness; fatigue; muscle and joint pain; muscle and joint pain; s... Read more
Severe headache; lightheadedness; weakness; fatigue; muscle and joint pain; muscle and joint pain; swelling in left armpit; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9Z61), via an unspecified route of administration on 01Feb2021 at 10:00 at a single dose on the left arm for COVID-19 immunization. Medical history included diabetes, hypertension (HTN), depression and polycystic ovarian syndrome (PCOS) all from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 (lot number: EJ1686) on 11Jan2021 at 10:00 on the left arm for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe headache, lightheadedness, weakness, fatigue, muscle and joint pain and swelling in left armpit on 02Feb2021. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
47 2021-03-06 swelling face, swelling, lymph node swelling Scratchy throat and tingly lips almost immediately, itchy inner wrists and ankles Growing to worst ... Read more
Scratchy throat and tingly lips almost immediately, itchy inner wrists and ankles Growing to worst point about 36 hours after injection: Swelling in throat, tongue, face, lymph nodes, generalized swelling (all the way to fingers and toes). Tingling in lips, tongue, face, scalp, left leg and left arm Shaking hands and racing heart, intermittently 48 hours later Entire left hemisphere of body want numb for about three hours. I freaked out and cried. *I had the vaccine in my left bicep, and I have a pinched nerve in that shoulder, which is teemed to activate. The nerve has never caused numbness beyond my left arm before, however, Last round of trembling about 48 hours after injection 72 hours later: Left tonsil and throat and armpit lymph nodes still swollen, but markedly less. Moderate numbness in left cheek and left side of throat, but less.
47 2021-03-07 lymph node swelling Swollen lymph node in left armpit.
47 2021-03-09 swelling swollen throat, itching all over body and swelling around base of the head, groin and buttocks. Tre... Read more
swollen throat, itching all over body and swelling around base of the head, groin and buttocks. Treatment- took Benadryl orally and topical Outcome- swelling and itchiness still exists
47 2021-03-09 swelling Large swollen spot in my right armpit; This is a spontaneous report from a contactable consumer (pat... Read more
Large swollen spot in my right armpit; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received first dose of BNT162B2 (brand= Pfizer Biontech), lot no. EL3248, via an unspecified route of administration (right arm) on 05Feb2021 15:00 at a single dose for COVID-19 immunization at a pharmacy or drug store. The patient had no relevant medical history. No known allergies. No COVID prior to vaccination. Concomitant medications included levothyroxine sodium and escitalopram. No other vaccine in four weeks. The patient experienced large swollen spot in her right armpit on 06Feb2021 16:00. No treatment received for the event. No COVID test post vaccination. The outcome of the event was not recovered.
47 2021-03-11 peripheral swelling Swollen arm at site @ 4 PM grew to shoulder by morning pain through whole arm. Headache, fatigue at ... Read more
Swollen arm at site @ 4 PM grew to shoulder by morning pain through whole arm. Headache, fatigue at 5 PM slept the rest of the day through 11 AM . Arm still swollen and red hot to the touch have put ice on it still getting bigger, tightness in chest and short of breath 2 days later , seen my dr she stated it is an allergic reaction and she recommended I do not get the second dose since this one has made me sick.
47 2021-03-13 lymph node swelling Chills, difficulty with breathing, tiredness, fever, swollen lymph nodes, and headache.
47 2021-03-14 lymph node swelling Swollen lymph node, headache, extremely tired & runny nose.
47 2021-03-14 lymph node swelling The night of the first dose, patient presented joint pain, stiffness and high temperature for 24 hou... Read more
The night of the first dose, patient presented joint pain, stiffness and high temperature for 24 hours. On the second dose, immediately had nauseas and vomiting. It felt like Hyperemesis gravidarum symptoms and high temperature for 36 hours. Pain and stiffness on the joints. Also swelling of the lymphatics under the left arm about size of a softball. Tiredness and felt sleepy for approximately one week.
47 2021-03-15 swelling face "my side effects from the Covid-19 shot on 03/06/21. I had fatigue, nausea, stuffiness with sinus pr... Read more
"my side effects from the Covid-19 shot on 03/06/21. I had fatigue, nausea, stuffiness with sinus pressure, headache, and swelling of the eyes/face. These symptoms began a few hours after the shot and subsided by Tuesday. I used over the counter medication to treat the symptoms. It was not severe enough for me to feel the need to seek additional medical care. If it had worsened, I would have gone to the doctor"--copied from pt email
47 2021-03-15 swelling, swelling face Noticeable swelling of face and neck about 20-25 min or so after vaccine . No breathing issues but f... Read more
Noticeable swelling of face and neck about 20-25 min or so after vaccine . No breathing issues but felt face tingling similar to hyperventilating. ER visit identified normal o2 and provided allergic reaction treatment of benadryl pills and prednisone injection right arm.
47 2021-03-16 anaphylactic reaction 47-year-old female presented for anaphylactic allergic reaction after getting her first dose of Covi... Read more
47-year-old female presented for anaphylactic allergic reaction after getting her first dose of Covid19 vaccine. Patient was initially seen by Dr., who then signed out to me pending observation and reevaluation. In summary, patient had received total of 2 EpiPen 1 at home and 1 in the ED in conjunction with soluMedrol, Benadryl, and Pepcid. Patient has history of anxiety and jittery as well as nervousness after epinephrine. Patient was then given 1 mg p.o. Ativan for her symptom. On my evaluation, patient is not in respiratory distress, She is still Tachycardic in the 110s-120s Which is likely from the EpiPen. Patient stated that she normally stays tachycardic for a while after the epipen. Patient otherwise not in respiratory distress, her posterior pharynx and her uvula is not swelling. Patient also has no wheezing on auscultation exam. We discussed the possibility of staying in the hospital under observation versus going home. Patient reported she is back at baseline and would like to be discharged and I was in agreement with this plan. Patient does has 3 more epipen at home to use for worsening symptoms. She will be prescribed medrol dose pack. Red flags signs and symptoms were discussed with strict return instruction were given. Patient verbalized understanding and was in agreement with the plan. She was then discharged in stable condition.
47 2021-03-16 peripheral swelling, swelling face This is a follow up report starting from day after that first report was made -Report # 244159 - Sta... Read more
This is a follow up report starting from day after that first report was made -Report # 244159 - Starting with the 17th of January - I was still having facial numbness/tingling/pressure in my head/feeling like head was going to swell; arms were so heavy - couldn't lift my arms - like a heavy pressure on my chest; breathing was a problem; Swelling in my head caused eye issues. 18th - tingling started on back of neck; affecting my hearing and eyes (swelling in head); a lot of cognitive challenges. 1-20-2021 - heart racing; itchy all over; blood pressure spikes. Heart can feel like it's too fast and then going too slow. 1-21-2021 - legs burning from waist to hip; chest pain; heart racing; struggling to breath. 1/22 - chest pain and discomfort - pain shooting through arms; didn't sleep well. Arms wanted to pull into my chest. Stomach cramping on 1/23 - stabbing pain in wrists and hands; left side on heart pain. Pain was like having a beating. Left knee pain - January 24 - up all night with shooting pain in arm; fine motor pain skills shot - can't do what I need to do. January 25 - Elevated heart rate; elevated blood pressure. 1/26 - vision challenges; fuzzy. Heart racing; feet swollen; face feels puffy doesn't look puffy - pressure/tingly feeling in left cheek. Ongoing and Changing symptoms every day/week - with no let up. 3/11/ - buckling of legs started. Big thing now is my legs are buckling (happening from the hips) - when I try to get up or walk. I haven't fallen yet but I know it's coming. 3/12/2021 - heavy weight back in the arms. I still don't have the fine motor skills. I still can't drive and don't have control over my body and reflexes enough. Still having Pressure in chest and the face and head swelling - is unbearable and affecting my vision. I will see a neurologist next month. Dr is not sure what to do. Jan 12 - first ER visit. I have specific notes/log on all of my symptoms each day. If anyone wants to call - please call on Mondays or Wednesdays only( or Saturday or Sunday.) Also, Menstrual cycle is wonky. I had a normal period before the vaccine - 12/28-12/31/2020 - but didn't have one in January and I had one in February 10th - but just one day; 3/11/2021 - I had my next one and it was four days long and fourth day was very heavy then all the rest of the days.
47 2021-03-16 swelling face I got shot in left arm and entire left side of my body reacted. One the day of the shot, I got muscl... Read more
I got shot in left arm and entire left side of my body reacted. One the day of the shot, I got muscle aches in my left leg and my left arm and leg felt heavy. During the night, I got extreme night sweats but ONLY on the left side of my body. Right side was dry. The next day I got a headache on the left side of my head only, the left side of my face was hot and right side was cool, aches in my left leg arm, neck, and shoulder. Then my left side of my face became numb and swollen. The numbness on the left side of my face got a little better every day but lasted for a week and even 2 weeks later it feels a bit tighter than the right side. I am supposed to get the 2nd shot in a week, and I do not believe I should but really need to talk to someone about this. No one is returning my messages and I have emailed VAERS.. please help.
47 2021-03-16 swelling Swelling red blotches burning feeling wierd shape tierd
47 2021-03-17 swelling Headache, Myalgia, Angioedema, Nausea Vomiting, INJECTION SITE PAIN, EXTREME EXHAUSTION Narrati... Read more
Headache, Myalgia, Angioedema, Nausea Vomiting, INJECTION SITE PAIN, EXTREME EXHAUSTION Narrative: Other Relevant History:
47 2021-03-17 axillary mass I received the vaccine in my left arm and shortly thereafter suffered a medium sized, painful lump i... Read more
I received the vaccine in my left arm and shortly thereafter suffered a medium sized, painful lump in my left armpit. So far its lated 4 days and occurred on the side where axillary Lymph nodes have not been removed.
47 2021-03-17 lymph node swelling SWOLLEN GLANDS
47 2021-03-18 lymph node swelling Felt faint at first , hives with in 10 mins, chewed 12.5 Benadryl, more hives chewed another Benadry... Read more
Felt faint at first , hives with in 10 mins, chewed 12.5 Benadryl, more hives chewed another Benadryl. Seemed ok after 45 post shot was allowed to leave drove home. Then about 1 hr post shot tight chest , itchy lips, puffy feeling lips, drive to urgent care, oxygen sat was 92 coughing swollen tongue gave myself epi, taken by ambulance to ER. Given more epi, Pepcid, steroids, Benadryl and Ativan. Was stable and discharged after 4 hrs. Next day very tired, throat sore lymph nodes swollen. Day 2 worse fever exhausted, sore muscles and joint pain. Increased Pepcid to 2 a day and 3 antihistamine a day. Day three increased steroids to 40 mg a day. Day 2 of increased steroids. Lymph nodes down , still exhausted, nausea, sore.
47 2021-03-19 lymph node swelling Fever Chills Nausea Swollen lymph nodes on clavicle and under arms
47 2021-03-19 lymph node swelling I had both vaccines injected on the left arm. The first one was on Feb 5th. My arm got very sore at ... Read more
I had both vaccines injected on the left arm. The first one was on Feb 5th. My arm got very sore at the site of injection the next day for about 24 hr. I started to notice pulsation on my ears. Then as the days went by, this turned into hyperacusis and I consulted about it on Feb 26th. the day of the second shot.. My physician referred me to an ENT. I saw the ENT on Feb 29 and had a hearing test the same day, they found no signs of hearing loss or abnormal conditions. I was diagnosed with pulsation tinnitus and hyperacusis. After the second dose, I had a skin reaction. I had redness at the site of the injection and developed a blister the same day. Then, two days later I noticed a swollen lymph node on the left side of the neck. My arm was very sore from the injection again. I noticed that the joints on my right arm are in acute pain.
47 2021-03-19 swelling 20 minutes post vaccination, patient developed rash, hives, swelling in both arms, neck and eyes, an... Read more
20 minutes post vaccination, patient developed rash, hives, swelling in both arms, neck and eyes, and headache. The patient did not report trouble breathing. Patient was given 600 mg ibuprofen and 50 mg diphenhydramine
47 2021-03-20 anaphylactic reaction Prior to the shot, my idiopathic anaphylaxis has been in remission. Since the shot, my throat and to... Read more
Prior to the shot, my idiopathic anaphylaxis has been in remission. Since the shot, my throat and tongue have been swollen. I cannot be around certain smells because my tongue and throat start to swell.
47 2021-03-21 lymph node swelling 7 days after 2nd shot began to develop 3 swollen lymph nodes under left arm. This is same arm as in... Read more
7 days after 2nd shot began to develop 3 swollen lymph nodes under left arm. This is same arm as injection. Swelling was red and painful. (I also became very sick after 2nd injection and was in bed for 2 days... had sweats, nausea, chills and brain was foggy.)
47 2021-03-21 lymph node swelling 1st shot only moderate soreness next day. 2nd shot in approx 5 hours I had chills, headache, body ac... Read more
1st shot only moderate soreness next day. 2nd shot in approx 5 hours I had chills, headache, body aches, extreme exhaustion, swollen throbbing ears, fever, nausea, and stomach ache went to bed woke up a 9 pm 102.5 fever barely able to function. Took Vicks 44 tried to sleep completely miserable. Took Tylenol to try to get fever down. Still so miserable I couldn't swollen because my ear pain was bad. My friend drove me to the nearest minor med. I couldnt tolerate any light, barely walk, dizzy and hurting all over. My lymph nodes started swelling up all over my body. I am still in pain and hurting , exhausted 5 days later. I have kept a constant headache, still exhausted, and can rest with pain meds.
47 2021-03-22 lymph node swelling sore arm the evening after the shot but gone in 24 hours. About 4 days later malaise, headache, swo... Read more
sore arm the evening after the shot but gone in 24 hours. About 4 days later malaise, headache, swollen lymph note on right side (shot on the left) so tired, no appetite
47 2021-03-22 lymph node swelling When I received the Pfizer-BioNTech COVID-19 I experienced soreness at injection site on the day of ... Read more
When I received the Pfizer-BioNTech COVID-19 I experienced soreness at injection site on the day of and the next day. I began having swollen lymph nodes 2 days after the injection and weakness in the upper arm and elbow area. I cannot lift my arm without discomfort.
47 2021-03-22 swelling face 10:45am Injection, mild headache 11am slightly dizzy 11:30am Arm sore - cont. to get more painful as... Read more
10:45am Injection, mild headache 11am slightly dizzy 11:30am Arm sore - cont. to get more painful as the day/night went on. Eventually, painful to lift. 12:30pm: Nauseous and not feeling well. Headache increasing. 7pm Migraine, chills, feeling awful, tired, muscle & joint pains, body aches, fever, left arm super painful. Slept restlessly Friday: Slept all day restlessly, chills, fever high of 102, tired, migraine, muscle & joint pain, no appetite. Sat: Migraine, some chills, muscle, joint, arm pain. Sun: Feeling much better, joint pains, arm sore, headache. Sun PM: Red, swelling, tingling on face around chin and mouth. - right side of face Mon: Rash on neck - right side of face Tues: Rash on torso
47 2021-03-23 lymph node swelling Swollen Lymph Node in Clavicle
47 2021-03-23 oral herpes Approximated 58 hours after my second vaccine, I went to go to the bathroom to void. My vagina felt ... Read more
Approximated 58 hours after my second vaccine, I went to go to the bathroom to void. My vagina felt itchy and then immediately afterward a very painful and swollen further inside. That was Friday night. for the remainder of the weekend I had terribly painful urination. I called my OB/GYN and scheduled an appointment for January 19. I prescribed Valtrex for possible herpes and Ciprofloxacin for possible bladder infection. The results came back as Oral herpes that were in my vagina. I would like to add that I did have a strong immune response to the second covid vaccine and had muscle aches, chills and malaise.
47 2021-03-23 peripheral swelling at the time of vaccine at the location, I had a rash and hives within 5 minutes of the vaccine. At ... Read more
at the time of vaccine at the location, I had a rash and hives within 5 minutes of the vaccine. At 30 min past the vaccine the vaccine center gave me 25 mg of benadryl and had me follow up with an urgent care center. I went home and took hydrozine because I continued to have hives and a rash, I could not afford to seek emergency help at the urgent care center and stated that to the vaccine center. The vaccine center said because I was able to breathe they could not transport me to the emergency room or urgent care center.
47 2021-03-23 swelling face After about 30minutes of shot l had feeling of fullness on my face and slightly warm ears for maybe ... Read more
After about 30minutes of shot l had feeling of fullness on my face and slightly warm ears for maybe 30seconds and immediately after that I had feeling of sinking as if l am going to die for 30 seconds and I was alright after.
47 2021-03-24 anaphylactic reaction itchy face Narrative: Moderate anaphylaxis reaction after administration of dose #1 Pfizer covid-19 ... Read more
itchy face Narrative: Moderate anaphylaxis reaction after administration of dose #1 Pfizer covid-19 vaccine. Tongue swelling and facial itching. Epi administered xl, patient transported to local ER for follow-up care.
47 2021-03-25 lymph node swelling Axillary lymphadenopathy on left side
47 2021-03-25 swelling, lymph node swelling, peripheral swelling Client returned to LHD on 3/25/21 at 9:40am complaining of significant swelling into neck and axilla... Read more
Client returned to LHD on 3/25/21 at 9:40am complaining of significant swelling into neck and axillary lymph nodes, redness, and difficulty moving arm. Redness was in an area over right deltoid approximately 4in vertically X 3 in horizontally. Redness did not go into shoulder, but started approximately 2 finger breaths below shoulder. Appeared vaccination was given in proper location. Client stated she was taking .Motrin and using the arm very frequently. She was tearful when moving arm. Client feels her pain threshold is high due to hx of broken hip in past and this pain seems worse. Client was very concerned about a worse reaction with a second vaccine. Client did state, " the nurse said I was a really small person so she was going to use a smaller needle." This nurse believes that means nurse at mass vaccination clinic used a 5/8 in needle. Client probably weighs 120-130lbs. Client did not and did not want to sign up for Vsafe. After discussion client decided to go to Urgent Care. Follow-up phone call to client at 12:30pm on 3/26. Client states Urgent Care Dr did not think it was cellulitis. Client was very fatigued and stated she then went to daughters and took 2 hour nap. She felt she did not want to go home by self as she was still very concerned. Client states, 'has hx of developing significant tongue swelling throat closing reaction to Bactrim about 4 days after starting and physician telling her in the ER she could have died if she did not come in'. Advised her to get 2nd vaccine. Client is still undecided about getting 2nd vaccine. Pain has decreased, but arm remains swollen and is now itchy. Client will continue to monitor and return to urgent care if symptoms get worse.
47 2021-03-26 swelling face, swelling 12:35pm - patient self administered Epi pen into her thigh - alerted EMS and MD on site, she was mov... Read more
12:35pm - patient self administered Epi pen into her thigh - alerted EMS and MD on site, she was moved to a private location and EMS began assessment. aprox 12:40pm EMS called for transport to a medical facility - the patient experienced vomiting, neck swelling, facial swelling and inability to speak - IV access was obtained by EMS and Benadryl was given IV - she was then given another IM injection of Epi by the EMS team she agreed to transport and was then transported to the hospital around 1:30pm
47 2021-03-28 peripheral swelling Minutes after injection, I developed pressure and pain in my ears followed by ringing. I was observe... Read more
Minutes after injection, I developed pressure and pain in my ears followed by ringing. I was observed for 30 minutes due to my prior anaphylactic reaction to a wasp sting. 40 minutes after injection, 10 minutes after leaving the pharmacy, I developed a welt-sized hive on my left foot. It was gone by the time I returned home. I then had hives on my left forearm. They went away with out treatment. At thas point, I had itching and swelling of the thumb on my left hand. That was somewhat painful. That was also the location of my wasp sting in July 2020. That also disappeared without any treatment from my of oinment or benadryl. I then found hives on my waist and stomach while lastly experiencing swelling on my lip. Again, this was all methodical almost over the course of 5-6 hours after injection. One hive would go away to have hives appear in another location. At 9pm that evening, I experienced sudden lower back pain on the right side and had difficulty walking due to the pain resulting from weight being placed on that side. My research suggested it was sciatica. I have no history of sciatica other than some discomfort during my pregnancies, the last of which was nine years ago. I treated this with 8oomg of ibuprofen and went to bed. Several hours later, I was awoken by the right leg shaking in my sleep. It was like a significant tremor. It stopped within a few minutes of me waking up. I was able to go back to sleep. However, I continued to experience sciatic pain on Sunday, March 28th and a bit today, March 29th. It has dissipated significantly and I am not functional. There was no repetition of the leg tremor after the initial and sole incident. I continued to have sporadic hives on my upper body on Sunday, March 28th. There are none present today, March 29th.
47 2021-03-29 anaphylactic reaction Anaphalactic
47 2021-03-29 peripheral swelling Pressure on chest; Respiratory allergies; swollen right hand; This is a spontaneous report from a co... Read more
Pressure on chest; Respiratory allergies; swollen right hand; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported), via an unspecified route of administration in the right arm on 25Feb2021 at 14:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies and food sensitivities. Concomitant medications included cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR) and lansoprazole (PREVACID); all were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to BNT162b2. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19 via nasal swab COVID-19 on 08Jul2020 with negative result and on 07Jan2021 with unknown results. The patient experienced pressure on chest, respiratory allergies and swollen right hand on 26Feb2021 at 10:30 PM. The patient was treated with diphenhydramine hcl (BENEDRYL) for the events, pressure on chest, respiratory allergies and swollen right hand. The outcome of events, pressure on chest, respiratory allergies and swollen right hand was recovering. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
47 2021-03-30 lymph node swelling Swollen lymph nodes in left armpit. Could barely move arm.
47 2021-03-30 lymph node swelling 1st dose my glands had some swelling; This is a spontaneous report from a contactable consumer (pati... Read more
1st dose my glands had some swelling; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EK9231), via an unspecified route of administration, administered in Arm Left on 06Jan2021 14:45 as single dose for covid-19 immunisation at Hospital. Medical history included, drug hypersensitivity (Allergies: Penicillin) from an unknown date and unknown if ongoing. Concomitant medication included esomeprazole sodium (NEXIUM) and ibuprofen. The patient previously took amoxicillin, codeine and experienced hypersensitivity. The patient reported 1st dose my glands had some swelling on an unspecified date. The action taken in response to the event for BNT162B2 was not applicable. Therapeutic measures were taken as a result of 1st dose my glands had some swelling (lymphadenopathy). The outcome of event was recovered.
47 2021-03-30 peripheral swelling Arm hurt; Little tired today/Exhaustion; Chills; Legs look swollen; Itching everywhere; Tested posit... Read more
Arm hurt; Little tired today/Exhaustion; Chills; Legs look swollen; Itching everywhere; Tested positive for Covid/can't stop coughing/ like the whole kind of flu symptoms, body aches, arm hurt; Tested positive for Covid; Hives all over body and tested for Covid 2 days later; This is a spontaneous report from a contactable consumer. The consumer (patient) reported that the 47-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer), via an unspecified route of administration, administered in Arm Left on 05Mar2021 15:15 at single dose for covid-19 immunisation. Medical history was none. Allergies to medications, food, or other products was nope. Concomitant medications were not reported. The patient previously took dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer), via an unspecified route of administration, administered in Arm Left on 12Feb2021 15:15 at single dose for covid-19 immunization. The patient experienced tested positive for covid on 07Mar2021 with outcome of unknown, hives all over body and tested for covid 2 days later on 06Mar2021 06:00 AM with outcome of recovering, can't stop coughing on an unspecified date with outcome of unknown, like the whole kind of flu symptoms on an unspecified date with outcome of unknown, body aches on an unspecified date with outcome of unknown, arm hurt on an unspecified date with outcome of unknown, little tired today/exhaustion on an unspecified date with outcome of recovering, chills on an unspecified date with outcome of unknown, legs look swollen on an unspecified date with outcome of unknown, itching everywhere on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Mar2021. She is not pregnant. She is not pregnant at the time of vaccination. No covid prior vaccination. Covid tested post vaccination included Nasal Swab, Pcr, on 07Mar2021with result of Positive. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was none. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 and test name was Pcr. The clinical course was reported as follows: Consumer stated, The other day, on Friday, I got my second dose of the Pfizer COVID-19 vaccine. And of course that's why I have like horrible symptoms, but since then I am covered in hives and it's really itchy. When paraphrased the concern, consumer stated, And then I just have a question, what happened was, we found out the same day, my son tested positive for COVID when I got the shot. And then like within 4 hours later of the shot, I can't stop coughing either. Means yesterday, I had like the whole kind of flu symptoms, body aches, arm hurt, you know, which are definitely going away. Little tired today but I still have the cough more in the throat and I am covered in hives. Consumer further stated, My husband and my other son were tested, they are negative. I am supposed to go today. Like I do not know what to do and I do not know what's going on but I am itching everywhere. Yesterday, I had like kind of the symptoms they said like body aches, like flu like symptoms, chills. I did not have a fever, just exhaustion and I did have hives yesterday but today I feel like my legs look swollen. I am itching everywhere and they are not away and I still have a 'cough like in ear through my throat' (not clarified). So, do you think should I still get tested today? Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information. Consumer stated, What should I do as I got the rash and everything. I would rather, I just need to get tested for the rash and the 'cough' (not clarified). Consumer stated, And they are going to give me information on these hives and everything? Inofrmation regarding lot/batch number has been requested.
47 2021-03-30 peripheral swelling swelling and pain to the left arm; swelling and pain to the left arm; throat closing; This is a spon... Read more
swelling and pain to the left arm; swelling and pain to the left arm; throat closing; This is a spontaneous report from a contactable Physician. This 47-year-old female Physician reported for herself that she started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration from 27Jan2021 to 27Jan2021 at single dose, dose number; 2 on left arm for covid-19 immunization. Patient was 47 years old and not pregnant at the time of vaccination. Patient's medical history included covid-19 from an unknown date in Apr2020 to an unknown date (if covid prior vaccination: Yes), known allergies to aspirin and lactose intolerant (dates unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number; unknown; reason; not available/provided to reporter at the time of report completion. via an intramuscular route from 06Jan2021 at 12:00 pm to 06Jan2021 at 12:00 pm at single dose, dose number; 1 on left arm for Covid-19 immunization. Facility type vaccine was reported as hospital. Patient was tested for covid post vaccination. Relevant test included nasal swab (covid test type post vaccination); rapid test (covid test name post vaccination) on 08Jan2021 which resulted as negative. Concomitant medication (if other vaccine in four weeks, other medications in two weeks) was reported as none. On 10Jan2021 at 10:00 pm patient experienced left axilla swelling and tenderness 4 days after the first injection with pain at the injection site with the outcome of recovering. She stated that ‘'scared I might have had breast cancer at the time, as there is family hx of cancer''. On an unknown date in Jan2021 she experienced repeat swelling and pain to the left arm which occurred less than 1 day after the second injection. She was concerned of the hot flashes and disturbed sleep consistent to the time when she was infected with covid back in Apr2020. She also experienced slight feeling of throat closing both times with the injections, with the first injection occurred 3-4 days afterwards with no SOB (shortness of breath) and with the second injection it occurred the within 24 hrs. No treatment for adverse event was given. The outcome of events was unknown.
47 2021-04-01 lymph node swelling after 1st dose of vaccine given in left arm, patient experience some arm soreness and noticed lump u... Read more
after 1st dose of vaccine given in left arm, patient experience some arm soreness and noticed lump under her left armpit with some swelling to area.
47 2021-04-01 peripheral swelling Started 1 minute after vaccination. Started with nausea and chest pain and tingling in vaccinated ar... Read more
Started 1 minute after vaccination. Started with nausea and chest pain and tingling in vaccinated arm down to hands/fingers. Swelling at injection site. Then started to feel hot/sweaty. Swelling occurred in bilateral arms and fingers and weakness in the legs. No breathing issues but then reported swelling of lips and tongue. Gave 50mg Benadryl. Called EMS with consent
47 2021-04-01 swelling Patient received the covid-19 vaccine, about 5 minutes after the patient starting having blurred vis... Read more
Patient received the covid-19 vaccine, about 5 minutes after the patient starting having blurred vision, at this point the pharmacy staff was alerted and the emergency kit was taken to the patient. The patient then started flushing and began swelling. Patient's vitals were normal but she continued to swell showing significant signs of allergic reaction. Patient was transported by ambulance to Hospital ER
47 2021-04-04 lymph node swelling swollen lymph node armpit left arm (same arm injection)
47 2021-04-06 lymph node swelling, lymph node pain Swelling and pain in my left lymph node under arm
47 2021-04-06 lymph node swelling lymph nodes inflammation Pain at the side of the shot Throughout the rest of my body: Tiredness. Hea... Read more
lymph nodes inflammation Pain at the side of the shot Throughout the rest of my body: Tiredness. Headache. Muscle pain. Chills. Fever.
47 2021-04-07 lymph node pain, lymph node swelling Swollen, painful lymph node at Left chest/armpit; red blotchy rash at injection site and on stomach
47 2021-04-07 lymph node swelling With in 6 minutes of receiving the injection my thyroid began to swell and the paramedic came to our... Read more
With in 6 minutes of receiving the injection my thyroid began to swell and the paramedic came to our car. He let us go because my throat wasn't swelling. When I got home, we noticed that my thyroid was so swollen we could see a heart every time I swallowed. That swelling continued for 4 hours and then the next day I couldn't move my arm. Over the weekend, I got so sick I was unable to leave the bathroom.
47 2021-04-07 lymph node swelling Sore arm; chills for a short period of time; hard lump on gum below left bottom tooth; swollen lymph... Read more
Sore arm; chills for a short period of time; hard lump on gum below left bottom tooth; swollen lymph node and sore throat on right side of neck.
47 2021-04-07 lymph node swelling My otherwise normal hormonal cycle has been completely disrupted. After the first vaccine shot on M... Read more
My otherwise normal hormonal cycle has been completely disrupted. After the first vaccine shot on March 4th, I had irregular bleeding following my period, but not heavy and because it was super light, I considered it unnoticed. However, after the second vaccine on March 25, I had heavier cramping exactly during the time I would normally have my period, but no period came. I am now 6 days late, which has never happened to me. I had all of the cramping and symptoms of a timely cycle, but no period at all! My cycle is normal, if not a day early. Never late. Additionally, the day after the shot, I had an enlarged lymph node under my arm pit for a few days that moved to a sensitive breast. Something is definitely wrong.
47 2021-04-09 lymph node swelling Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 47-year-o... Read more
Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) via an unspecified route of administration, in right arm on 19Mar2021 (at the age of 47-year-old) at single dose for COVID-19 immunization. The patient's medical history included hypothyroidism and asthma. The patient has no allergies to medications, food, or other products. The patient's concomitant medications included unspecified thyroid medication. The patient was not pregnant and didn't receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient hasn't been tested for COVID-19. The patient experienced swollen lymph nodes on 23Mar2021. The patient didn't receive any treatment for the event. Outcome of the event was not resolved. No follow-up attempts are possible. No further information is expected.
47 2021-04-09 swelling face, peripheral swelling About 30 seconds after my shot, my throat felt like it was closing and my face started to swell up a... Read more
About 30 seconds after my shot, my throat felt like it was closing and my face started to swell up as well as my hands. Then My right ankle swelled up. My face and hands had hives on them. My throat felt better, I thought but about 1/2 hr. Later I started wheezing and my right ankle and leg were swollen so, I went to the urgacare. They saw me but told me that I should've gone to the ER. I have a history of anaphylaxis. They gave me steriods and Benadryl via shots and sent me home with the same. I woke the next morning with a sore arm, a horrible headache and my face broke out into hives and was swollen again. Today is the 4th day after and my face still feels a little swollen, I have a headache and now an earache in my left ear. Today I also felt nauseous and couldn't eat.
47 2021-04-10 lymph node swelling The day after my second dose injection on the left arm, I found that my left armpit was visibly swol... Read more
The day after my second dose injection on the left arm, I found that my left armpit was visibly swollen and uncomfortable. That was yesterday. I have not taken anything for it and have massaged the area as well as put warm compress on it last night. It?s still swollen today.
47 2021-04-10 peripheral swelling *pain injection site-2 days *fatigue and tiredness-12 days *Severe inflammation and swelling of hand... Read more
*pain injection site-2 days *fatigue and tiredness-12 days *Severe inflammation and swelling of hands, feet, arms, and back. (Worsened over 12 days) *Joint pain in hands and feet. (Worsened over 12 days)
47 2021-04-11 anaphylactic reaction "1423 History of present illness-patient is a 47-year-old female with a significant past medical his... Read more
"1423 History of present illness-patient is a 47-year-old female with a significant past medical history presenting to the emergency department with large reaction. Patient received the Pfizer colored vaccination approximately 45 minutes prior to ED arrival. Patient had hives, throat swelling. EpiPen and Benadryl were administered. Patient has had significant improvement in her symptoms. Currently note throat swelling or shortness of breath. Hives markedly improved. [SM] 1425 Medical decision making-47-year-old female presenting to the emergency department with allergic reaction. Likely anaphylaxis given airway involvement. Covid vaccination was likely trigger. Will administer Pepcid and prednisone. [SM] 1426 Patient has been improving throughout the 2-hour ED stay. Will discharge with prescription for prednisone as well as EpiPen. Patient instructed to follow-up with PMD. She expresses a full understanding of the plan and is amenable to it. Strict return precautions given. All questions answered. "
47 2021-04-11 lymph node swelling, swelling face Facial swelling and hives, onset about 3 hours post-injection. Managed with diphenhydramine 25mg eve... Read more
Facial swelling and hives, onset about 3 hours post-injection. Managed with diphenhydramine 25mg every 4-6 hours for 4 days. Mostly resolved within 2 days with lingering symptoms resolving within 5. Headache, fever (100.3), body pain, swollen lymph nodes in armpit, brain fog onset within 12 hours. Resolved within 36 hours with sleep.
47 2021-04-11 oral herpes Cold sore in new location. Face, left side, below bottom lip.
47 2021-04-11 peripheral swelling, swelling I was starting my period (light spotting) and it just stopped after the first dose. That was Mar 9, ... Read more
I was starting my period (light spotting) and it just stopped after the first dose. That was Mar 9, 2021. I have not gotten my period since. According to the doctors as well as my menstruation cycles prior there were no signs or peri menopause or menopause. Additional symptoms: After the first dose: (lasted for 3 weeks) Extreme fatigue. (Sleeping 20 hours a day) Swollen joints. (Radiating pain from the occipital ridge downward through out the spine & the right knee). Constant pain in my neck, shoulders, hips. Brain fog. Blurry vision/vision changes and things looked like they were vibrating/jumping Numbness in my face Tasted metal in my mouth Nausea Diarrhea Loss of appetite Depression After the second dose (lasted 10 days) Entire left arm was in pain Swollen and stiff from left arm, base of my occipital ridge/top of spinal column , neck shoulders, all the muscles between my shoulder blades the day after. Starting on day 3, all the areas up and down my spinal column felt swollen, stiff and in pain. Dissipated after 10 days. I lost mobility in my hip joints. Swollen right knee ( I am still experiencing these 2 symptoms, 4/12/21). Fatigue Brain fog. Diarrhea. Nausea Loss of appetite
47 2021-04-12 lymph node swelling, lymph node pain Within 24 hours of getting the first dose, my right neck lympnode is really swollen. I could feel so... Read more
Within 24 hours of getting the first dose, my right neck lympnode is really swollen. I could feel soreness on the lymph node 1 day after the dose and on day 2...there is more pain and it is swollen.
47 2021-04-12 lymph node swelling slight fever swollen lymphnode nausea lightheadedness
47 2021-04-12 lymph node swelling About 30 minutes after vaccine, strong headache on left forehead, left arm and hand felt funny (tig... Read more
About 30 minutes after vaccine, strong headache on left forehead, left arm and hand felt funny (tight, strange sensation), left shoulder and neck was tight/sore/aching, and left cheek/face felt tight - strange sensation, left jaw was tight and joint was popping (happens when I get dental fillings). I could feel a tight strange sensation on the left side only - could tell it was not crossing my midline, no strange sensation on my right side at all. I still had feeling and movement on the left side but, felt really weird and tight- similar to the feeling after a dental filling anesthesia is wearing off. Weird sensation wore off by evening. Arm was sore for 3 days. 9 days after vaccine outer areas of breast were very sore and at 10 days felt a lump under right armpit. Developed hives on both forearms 12 days after vaccine. Had headaches on and off for one week. Had fatigue for about 4 days.
47 2021-04-13 lymph node swelling, lymph node pain Swollen and painful lymph nodes. Rash on the breasts.
47 2021-04-13 swelling 1135 RNs responded to vehicle 2 to c/o dizziness, numbness in hands, swelling nasal passages. Pt ale... Read more
1135 RNs responded to vehicle 2 to c/o dizziness, numbness in hands, swelling nasal passages. Pt alert, oriented, denies SOB. Benadryl 25mg PO ADMINISTERED PER 50 Driver moved car to front of lot. Pt reported further dizziness, headache, tongue becoming thick. 1145 RN contacted Dr. instructions to give another 25mg Benadryl PO
47 2021-04-13 white blood cell count increased hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat wa... Read more
hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat was starting to swell. Used Epi pen #1 . I did not get better. I felt even more on fire and my skin was hot to the touch. My tongue was really swollen and things get super fuzzy after the I might die feeling. Epi#2 Given around 5 minutes after Epipen 1. Medics took me to the ER and more rescue meds were given. I was admitted to the nuero trauma floor for 24 hrs and given meds and iv fluids. I got out the next afternoon. By the next day I was back in urgent care. They gave me meds and sent me home. By 9pm that night I was using epi#3 and going back to the ambulance. I have been to urgent care 2 times since for continued issues. I have zero appetite and my whole GI system hates me. I am alive and breathing but still feeling the impact of all of this.
47 2021-04-14 lymph node pain On Wednesday 4/14/21, Left Lymph Node area painful. By Thursday 4/15/21 pain was a less but felt lik... Read more
On Wednesday 4/14/21, Left Lymph Node area painful. By Thursday 4/15/21 pain was a less but felt like it (the pain) was running down the underneath of my left arm through my elbow.
47 2021-04-14 lymph node swelling Swollen lymph node in the armpit of the arm that received injection (left)
47 2021-04-14 lymph node swelling Lymph node swelling by right side collarbone. Was pretty tender for nearly a week. And general mark... Read more
Lymph node swelling by right side collarbone. Was pretty tender for nearly a week. And general marked fatigue for ~10-14 days afterwards.
47 2021-04-15 peripheral swelling Started having headache, chills and body aches on 4/1/2021. On 4/2/2021 I had major fatigue. On 4/4/... Read more
Started having headache, chills and body aches on 4/1/2021. On 4/2/2021 I had major fatigue. On 4/4/2021 my right leg began to swell terribly and then on 4/6/2021 it was discovered that I had one big and many small blood clots in my right leg.
47 2021-04-17 peripheral swelling Bilateral leg swelling 2 days after dose of vaccine, followed the next day by blotchy raised purple ... Read more
Bilateral leg swelling 2 days after dose of vaccine, followed the next day by blotchy raised purple skin rash covering length of both legs Suspect autoimmune reaction
47 2021-04-17 peripheral swelling April 17th 10:28 Took Vaccine 10:45 Reaction started with tightening of my throat and drank some wat... Read more
April 17th 10:28 Took Vaccine 10:45 Reaction started with tightening of my throat and drank some water 11:00 ish gums started swelling and lips tingling My hands and tongue started swelling and my face was warm 11:15 ish-took 25 mg Benadryl via shot 12:27-arrived at ER for monitoring 2:22-took Pepsid and steroid ( dexamethasone) orally 4:00-50 mg of Benadryl orally 10:00 pm- 25 mg Benadryl and Pepsid tablet April 18th Symptoms: ? Face flushed and stretched ? Face and neck itchy / small hives ? Mentally scattered ? Auras Headache 4:00 am - 50 mg of Benadryl oral 10:00 am - 25 mg of Benadryl oral 10:00 Pepsid 11:00 Tylenol 4:00 Tylenol 6:00 Benadryl 7:25 Imetrex
47 2021-04-18 lymph node swelling 103. fever began 12;30 Saturday morning , body aches, headache felt like my head was going to explo... Read more
103. fever began 12;30 Saturday morning , body aches, headache felt like my head was going to explode. fever of 102 continued into Sunday morning severe arm pain at sight of injection also underarm tenderness. all of my armpit glands are swollen around inside of my arm near left breast. fever finally subsided Monday morning.
47 2021-04-18 peripheral swelling, swelling face Adverse effect from 1st dose of Pfizer vaccine for COVID: - swelling of head with hives, - swellin... Read more
Adverse effect from 1st dose of Pfizer vaccine for COVID: - swelling of head with hives, - swelling of face, lips, eyes - swelling of feet, - shortness of breath, chest tightness - extreme itching and rashes across all over body.
47 2021-04-18 swelling face Increased heartbeat Facial swelling throat swelling Shortness of breath Itchy skin
47 2021-04-19 peripheral swelling At the time of the administration of the vaccine I felt a strong pain that I can describe in the who... Read more
At the time of the administration of the vaccine I felt a strong pain that I can describe in the whole body, since that day I started to feel bad, severe pain in the arm with swelling, pain in the breast and neck ... the pain is very acute, it has been increasing, I have visited the emergency room, emergency and my primary doctor and even to this day I am still the same, I have had not had improvement
47 2021-04-19 swelling swollen and sore under arm in armpit
47 2021-04-19 swelling Swelling about 2in wide, sore, and hard
47 2021-04-20 swelling face Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-M... Read more
Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: pt reported slight swelling in throat but no trouble breathing, paramedics came and checked vitals and cleared, pt was monitored for an hour and given benadryl, symtoms went away and pt left
47 2021-04-21 lymph node pain, lymph node swelling High/Drunk feeling within 1 hour of shot, Not able to sleep at night for first 72 hours (2 hrs 1st ... Read more
High/Drunk feeling within 1 hour of shot, Not able to sleep at night for first 72 hours (2 hrs 1st night, 4 hours 2nd night, 4 hours 3rd night), Very low mood and wishes I would die on 4/15 morning as pain/discomfort was so great. Severe Chills (shaking, needed 3 blanket) from late afternoon to early morning hours during the 1st 72 hr post injection, Severe night sweats 1st 3 nights - body was soaking wet and soaked through pajamas, Joint and muscle pain in arms, legs, face/jaw starting the 1st night after injection and continuing for 4 days after injection, Swollen, painful lymph nodes in under arm/neck - continues to this day (started night 1 and now 9 days after injection), Occasional dizziness when standing and sitting starting 4 days after injection and continuing for 48 hours, Blurred vision, people looks like they were swaying starting day 5 through day 6, Very Heavy vaginal bleeding started on day 7 (4/20), got worse on day 8 (4/21), and the same on day 9 (4/22): soaking through pad every 2-3 hours on day 8 and day 9. bleeding continues at time of this report. NOT like a period, or timing of my period. My period is not due to start until 4/25 and I have been regular my entire life - 36 years! Cough and left arm pain started on day 8 (4/21) - I went to ER after calling my OBGYN and talking with the nurse. NEVER had a fever, NEVER had cramps.
47 2021-04-21 lymph node swelling, lymph node pain 1st Day - Extremely tired, Nauseous 2nd Day - Fatigue, Nauseous, Ribs hurt, body hurt 3rd Day - same... Read more
1st Day - Extremely tired, Nauseous 2nd Day - Fatigue, Nauseous, Ribs hurt, body hurt 3rd Day - same as day 2 4th Day - felt better 6th Day - Rapid heart rate / anxious 7th Day - Pain in my neck and found large Lymph Node in neck/clavicle 8th Day - Couldn't get out of bed, felt like a truck hit me, Lymph Node still enlarged in neck and also under left underarm. Went to Doctor she confirmed it was Lymph Nodes - 5 CM in my neck with 4 -5 of them enlarged, and 3 - 4 under my left arm. Also behind my knee 9th Day - Lymph nodes still the same size and very painful, now in my groin area. Still exhausted. Went for Chest X-Ray, negative 10th Day - Still the same, trouble walking 11th Day (today)- Still the same, more pain
47 2021-04-21 lymph node swelling PATIENT SAYS SHE IS EXPERIENCING PAIN ON THE SIDE SHE RECEIVED THE VACCINE AND HAS ENLARGED LYMPH NO... Read more
PATIENT SAYS SHE IS EXPERIENCING PAIN ON THE SIDE SHE RECEIVED THE VACCINE AND HAS ENLARGED LYMPH NODES, SHE WENT TO DOCTOR AND HAD A CHEST XRAY WHICH WAS NEGATIVE. ALSO HAD INCREASED LYMPH LEVELS IN HER BLOOD
47 2021-04-21 swollen extremities 17 hours post vaccine had chills, profuse sweating, headache, nausea, lethargy, lack of appetite. ... Read more
17 hours post vaccine had chills, profuse sweating, headache, nausea, lethargy, lack of appetite. 44 hours post vax - felt better and decided to take a shower. Felt faint in the shower. Returned to bed and went into a full body cramp. My arms, hands, legs, feet all went into a severe cramp. My husband was unable to extend my arms or get my fingers to unfurl. I was in extreme pain. My lips started tingling and my word started slurring. My husband called 911. I was diagnosed with dehydration and low potassium. My potassium was 2.6 I received 3 bags or fluids. Pain meds. A potassium drip and oral potassium at the emergency room.
47 2021-04-21 swelling face After 2 days I had face swelling. I used steroids to treat. I still have pain in my injection site 1... Read more
After 2 days I had face swelling. I used steroids to treat. I still have pain in my injection site 13 days later. There's a dull achy pain, as well, in my left back shoulder.
47 2021-04-22 swelling Strong headache, body pain, tiredness. On the 3rd day a bump appear next to my shoulder, the same s... Read more
Strong headache, body pain, tiredness. On the 3rd day a bump appear next to my shoulder, the same side as the vaccine.
47 2021-04-23 lymph node swelling Swollen lymph node (right arm pit), violent chills, wave of cold spots at top of shoulders to base o... Read more
Swollen lymph node (right arm pit), violent chills, wave of cold spots at top of shoulders to base of neck and back of skull.
47 2021-04-23 swelling face Immediately after shot - light headed, nausea, high blood pressure - treated (monitored) by paramedi... Read more
Immediately after shot - light headed, nausea, high blood pressure - treated (monitored) by paramedic at vaccine clinic and sent home; 3 hours later - swelling on the left side of face - treated at my physicians office
47 2021-04-24 lymph node pain, lymph node swelling Swollen lymph node in left armpit. Painful, bruised feeling.
47 2021-04-24 lymph node pain I felt fine the first 12 hours after the shot other than a little bit of brain fog. 12-36 hours aft... Read more
I felt fine the first 12 hours after the shot other than a little bit of brain fog. 12-36 hours after the shot, I felt terrible. I was achy, sweaty, had chills, no appetite and two waves of nausea. I had trouble sleeping. I ate very little during this time (toast, banana, soup), and threw up once. I had to rest all day. My left arm hurt and my lymph node by my left armpit hurt. (I have had ultrasounds over the past couple of years of my left breast/armpit taken due to an enlarged dense lymph node discovered on a mammogram. The ultrasounds have showed no increase in growth, and no signs of cancer.) I started feeling better 36 hours after the shot. It's now just over 48 hours post-vaccine. The lymph node pain remains and if I try to do anything even mildly strenuous I get flushed and tire easily, so I have been mostly resting. This was my second shot.
47 2021-04-24 lymph node swelling Chills, headache, fever, muscle aches, swollen lymph node in armpit.
47 2021-04-25 anaphylactic reaction Patient had an anaphylactic reaction to the Pfizer Covid19 vaccine. She had chest tightness in the f... Read more
Patient had an anaphylactic reaction to the Pfizer Covid19 vaccine. She had chest tightness in the first 10 minutes and received two oral Benadryl capsules. At about 20 minutes post vaccination, she then felt her throat swelling up and we then had to give her three epipens. Her symptoms included chest tightness, shortness of breath, coughing, and eventually throat swelling, which resulted in a brief, repeated loss of consciousness.
47 2021-04-25 lymph node pain, lymph node inflammation Lumps in my left breast became suddenly swollen, hard and painful. The pain extended to my arm pit. ... Read more
Lumps in my left breast became suddenly swollen, hard and painful. The pain extended to my arm pit. The swelling of the breast was pronounced enough that the entire left breast was visibly larger than the right breast. The swelling took a week to subside, but has not gone. The pain subsided in a week, but remains as I fill in this form. The pain is in both the breast and the arm pit of the left side.
47 2021-04-25 swelling Three days after vaccination, cluster of itchy bumps developed on forehead. Initially looked like bu... Read more
Three days after vaccination, cluster of itchy bumps developed on forehead. Initially looked like bug bites. Cluster expanded and swelled for a few days and then developed open sores. Fatigue, body pain symptom began and lasted for weeks. Over the next two weeks the sores formed large scabs. Initially diagnosed as bacterial infection; later rediagnosed as shingles outbreak. Symptoms slowly healing but some pain is persistent as of April 25th.
47 2021-04-25 swelling Itching, red swollen chest (hot to touch), hives on neck to chest area, metal taste in mouth.
47 2021-04-25 white blood cell count increased 7 minutes after vaccination: shortage of breath, high blood pressure 148/96, irregular and intense h... Read more
7 minutes after vaccination: shortage of breath, high blood pressure 148/96, irregular and intense heart beat, intense body shaking. I was taken to emergency hospital right away for next 6 hours and then released home. Following day after vaccination: pain in the kidneys' area started, light pressure in the heart area Second day after vaccination: pain in the kidneys' area, lower and upper back pain, low blood pressure part of the day (94.5 F) Kidney area still in pain.
47 2021-04-26 lymph node pain, lymph node swelling LEFT SIDE, lymph node just above the collar bone is swollen to the size of a quarter and tender to t... Read more
LEFT SIDE, lymph node just above the collar bone is swollen to the size of a quarter and tender to the touch.
47 2021-04-26 lymph node swelling diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/... Read more
diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/swollen glands; swollen injection site; tired; mouth ulcers; extreme nerve pain; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 08Apr2021 15:00 (Batch/Lot number was not reported) at single dose (at the age of 47 years old) for COVID-19 immunisation. Medical history included "if covid prior vaccination: Yes". Concomitant medications included potassium, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), cetirizine and chlorthalidone, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 for COVID-19 immunisation. The patient reported, "fever, muscle aches, headache, throwing up, chills, swollen lymph nodes, swollen injection site, tired. After chills, fever, throwing up, mouth ulcers. On day 7 I have extreme nerve pain, swollen glands, and paralysis on left side of face. Went to DR and they diagnosed with Bells Palsy. Left side of face does not move at all", 09Apr2021 09:00. The patient received no treatment. The outcome of bells palsy, extreme nerve pain, mouth ulcers and swollen lymph nodes/ swollen glands were not recovered and other events was recovering. Information about lot/batch number has been requested.
47 2021-04-26 peripheral swelling Received #1 Vaccine Friday at 1pm Fri evening about 8-9p My back(kidney area was sore) having s... Read more
Received #1 Vaccine Friday at 1pm Fri evening about 8-9p My back(kidney area was sore) having sharp pains throughout my organs. Woke up Sat am,could not move, my whole body was in so much pain, My back,kidney area, stomach, uterus area. I was in so much pain, could not get out of bed, felt like insides were ripped out. Right arm I couldn't move,swollen. As of Tues 4/27 ,back still sore, but getting around. I supposed to get my 2nd vax May 14, after going through this. I do not want to go through this again. I've given birth and had several surgeries, I could deal with all that more than this pain.
47 2021-04-26 swelling, swelling face No treatment at the time. If i couldn?t swallow a glass of water or couldn?t breathe would have gon... Read more
No treatment at the time. If i couldn?t swallow a glass of water or couldn?t breathe would have gone to ER. Nonstop headache for over a week. Saw Dr. today and it was better today otherwise she would have prescribed a steroid pack.
47 2021-04-26 swelling I had a tattoo done on Sunday night (4/18). I have had many tattoos before this. The first two days ... Read more
I had a tattoo done on Sunday night (4/18). I have had many tattoos before this. The first two days of healing went great, but I woke up on Thursday morning with horrific symptoms. Weeping fluid and ink to the point where my skin was coming off in sheets. Extreme pain, swelling and bleeding. I assumed it was an infection or an allergy, but it is not infected. I don't think it was an allergy, unless it was a mild allergy exacerbated by the vaccine. Healing has been truly terrible and I'm still on the road to recovery now.
47 2021-04-27 lymph node swelling, peripheral swelling Fatigue (still ongoing), Swollen lymph nodes in neck and underarms (still ongoing), Fever (day 1 e... Read more
Fatigue (still ongoing), Swollen lymph nodes in neck and underarms (still ongoing), Fever (day 1 evening and into day 2), Nausea (day 1 evening and into day 2), Headache (day 1 and into day 4), Chills (day 1 and into day 4), Red itchy rash causing swelling on top of wrists on both arms (started day 3 and still ongoing)
47 2021-04-27 swelling face Patient received 1st dose covid vaccine; during observation period experienced slight red rash acros... Read more
Patient received 1st dose covid vaccine; during observation period experienced slight red rash across chest, very slight facial swelling around lips, and facial flushing; patient stated this was usual reaction to vaccines; 50 mg benadryl given along with cool water; symptoms started to subside, patient felt ok, blood pressure was within normal range; patient was released after all symptoms gone (approx. 40 minutes total observation time) with recommendations if symptoms reappear to either go to ED or call PCP.
47 2021-04-27 white blood cell count increased 4/22- within minutes I felt dizziness and unsteady but was sporadic. As the day continued, became mo... Read more
4/22- within minutes I felt dizziness and unsteady but was sporadic. As the day continued, became more fatigued. 4/23 - Continued with previous symptoms and added headache, more fatigue, nausea, and chemical taste will all food/drink 4/24 - Continued with above symptoms and added: muscle aches, joint stiffness, extreme nausea and vomiting and weakness, severe fatigue. Went to ER for evaluation. (see below) Received IV fluids and Zofran In the 3 days since the ER visit, I am still unable to eat any solid food and can only drink after taking Zofran
47 2021-04-28 peripheral swelling Pt states that she developed right forearm pain and swelling the day after. She was seen by me on 4/... Read more
Pt states that she developed right forearm pain and swelling the day after. She was seen by me on 4/29/21 and diagnosed with DVT radial and cephalic veins. Also with SVT of the fore arm.
47 2021-04-28 peripheral swelling covid-arm redness and swallow, hot and itching (not too much and not for a long period) after the 8t... Read more
covid-arm redness and swallow, hot and itching (not too much and not for a long period) after the 8th day of the vaccine.
47 2021-04-28 swelling face, lymphatic obstruction It's 7 days later and I am still not well - face swelling, hot to the touch (similar to when I had s... Read more
It's 7 days later and I am still not well - face swelling, hot to the touch (similar to when I had staph infection) Nausea is new as of today, migraine has come back (was present up until yesterday afternoon and started to dissipate and now back in full force). I have had 17 concussions in my lifetime so it feels like that a bit, foggy, can't stand for long, fatigue. Here are my symptoms by days. Would have sent this sooner but couldn't function or look at screen- really sick. I am still sick and not sure if this is normal or I should be going to the ER or some type of doctor. 4/22/21 ? 2nd Shot at 10:35 am - @ 1:45 pm arm really started to get soar and hard to lift. Chills. Drossy. 4/23/21 ? After I awoke from the 1st night, I couldn't move my entire body's left side, I was dragging my left leg with me and couldn't lift my arm from my body or move it. exhausted felt drugged, like hangover, migraine and getting in car accident all in one. Kept dozing off. Slept a lot. Head felt similar to concussion. Unable to really walk. 4/24/21 ?Slept a lot during day. Arm and leg mobility better and I could finally feel my left fingers. So much pain so I finally took my 1st Tylenol muscle 8 hr at 9:38 am. Took another at 10:30pm. It helped for about 5 hours and then woke up with sharp pains again. At night, shooting pains in legs especially back of legs and burning I?m in a lot of pain so while I can now feel my left side and move my arm a bit better my legs are still in a constant state of shooting spasm and I can?t lay down, sit up, recline or anything. Nothing brings comfort. It?s like taking an electrical prod to my body. Arm still hurts (NOT at injection site) but can move it better now still feels like sinus infection. It?s like muscles are pizza dough and someone is pulling them, stretching them painfully with electrical current when you aren?t moving. Massive spasm all over back of legs hips from bottom down. Eyes really swollen. Did Sinus Rinse. Under my arm put and beside/behind my breast rib cage sore. 4/26/21 - Pain wakes as usual throughout the night but it?s 4:40am and the Tylenol has worn off. Pizza dough pulling and spasms in the legs. I?ve taken more Tylenol in the last 4 days than I have taken in the last 40 years. I felt like I didn?t have a headache when I got up but my legs were still streaming so I took another Tylenol and I have a headache and don?t feel good. I now am able to move arm but extremely painful like a log, I can lift it only 1.5 inches from my body which is more than I could before so it must be getting better. Head still feels similar to concussion with migraine. The headache is causing me to clinch teeth and the headache is not at the level it was but still pretty bad. None of this pre -2nd shot. When I was about 12yrs old I had Rheumatoid arthritis (or that was the drs explanation) and this is what it felt like, I couldn?t move my legs or my arms then. I did not take any Tylenol tonight. Shoot pains only wake me up 3 times although they are constantly there just the strength differs Dr?s have always said I have extremely high threshold for pain. I was finally able to brush my hair, afterwards my arms were shaking muscle wise and fatigued. Rash inside my ear and face blotchy. 4/27/21 ?No real change in symptoms except now I am seeing my face swell and eyes are still burning and painful. My face only on the left side more than right looks like a cabbage patch doll- swelling. Eyes sore and front of head hurts. Stuffy nostril only left one ? so I do another sinus rise today. Still feel drugged. Body is sore. Hard to move neck. Still in pain take Tylenol at 9:20pm. The pain woke me up multiple times and kept me up. It?s like someone is pulling my muscles like pizza dough. It is so painful. No position is comfortable. Woke up at 10:30, 11:45, 12:15, 2:21, 3:52, 4:05 and that was it couldn?t get back to sleep because of this pain. Don?t have a foam roller here but maybe an olive oil bottle I could use in the same manger or a tennis ball. I have to do something I can?t take this pain. 4/28/21 ? 8:32 am having trouble lifting my arm, very heavy fingers numb fatigued like I just lifted something really heavy by myself. I was finally able to move arms enough to was the dishes. Left side of face still swollen. Under my arm put and beside/behind my breast rib cage still sore. Finally, was able to take bath. Not hot because I didn?t want any more swelling. 4/29/21 ? Only woke up a couple of time and slept better so thought I would try to go for a walk outside today. My headache I thought was pretty much gone. I didn?t last more than 8 mins. I felt like I couldn?t stand, exhausted, not strong enough and needed to sit down. My migraine is back and I feel nausea, not hungry, face is swollen still. I have lymphedema and use my machine every night, but it?s almost like the shot increases inflammation all over my body, find the places that have been affected before and gets in there. I only drink water, no coffee, tea or juice and no alcohol since 3 days before my 1st shot and was planning to continue that until 2 months after my 2nd shot.
47 2021-04-29 lymph node swelling Largely Swollen lymph node on right arm upper pit area.
47 2021-04-29 swelling Rash , swelling , itchy And pain experienced on the arm after 1 week of vaccine 1 st dose
47 2021-04-30 lymph node swelling, swelling 1st shot: fatigue, arm pain, and left armpit pain (duration: a day) 2nd shot: (24 hrs. after shot - ... Read more
1st shot: fatigue, arm pain, and left armpit pain (duration: a day) 2nd shot: (24 hrs. after shot - duration 2 days) headache, body ache, sore jaw, swollen chest and armpits, gastroinestinal issues, achey joints 2 weeks to the day after 2nd shot: sore, swollen, tender breasts and armpits; next day: mammogram resulting in injury to swollen lymph nodes that were an unknown reaction to the vaccine. It has been over a week now, and doctors are telling me this is going to be a process. I have been to the ER, and have had multiple tests ordered for imaging, but I am awaiting pre-authorization from insurance company. I am a teacher and doubt I will be physically able to return to work this school year.
47 2021-05-01 peripheral swelling Swelling underneath arm, on top of right collarbone, numbness and swelling along right arm, swollen ... Read more
Swelling underneath arm, on top of right collarbone, numbness and swelling along right arm, swollen fingers and tingling sensation on right hand
47 2021-05-03 lymph node swelling Day after second Pfizer vaccine in the am woke to bad hip pain and stiffness in the right arm from t... Read more
Day after second Pfizer vaccine in the am woke to bad hip pain and stiffness in the right arm from top of arm at shoulder to hands felt stiff feels inflamed though not visible and muscle pains .This arm stiffness and feeling is still l on going and it seems worse when I wake up in the am though I sleep on my back . The lower back muscle pain come sand goes but the pain in my hips around my back is on and off not sure if this is related to vaccine but the day after the vaccine it was so bad hard to walk then it seem to ease by nine pm that day . My arm stiffness is on going. I had swollen lymph nodes under my right arm that started the 16th April two days after the second vaccine lasted about a week or a few days past the week . Day after second vaccine I had very bad muscle pains an stiffness in my back hips especially and arm and even had slight jaw pain the right side .I felt cold starting around two pm that day on and off then around five pm to eight pm or nine pm had chills come and go those went by around nine pm that all stopped .
47 2021-05-03 white blood cell count increased Patient received her second dose of Pfizer COVID-19 vaccine on 4/21/2021. She has a purpura-like r... Read more
Patient received her second dose of Pfizer COVID-19 vaccine on 4/21/2021. She has a purpura-like rash on extremities and trunk that started within days of receiving her second COVID-19 vaccination from Pfizer. Assessment: Purpura (CMS/HCC) Thrombocytopenic purpura (CMS/HCC) Plan: CMP D-dimer, Quantitative CBC w/ diff, PT, PTT Referral to Hematology/Oncology
47 2021-05-03 white blood cell count increased Vaccine at 6pm, itching rash on lower trunk and left armpit by 9pm, took Benadryl. Increasing sever... Read more
Vaccine at 6pm, itching rash on lower trunk and left armpit by 9pm, took Benadryl. Increasing severity, coverage of body and so I went to Urgent Care Sunday, May 2nd about 3:15 received by iv liquid Benadryl, Pepcid and Prednisone. Instant relief and rash began to fade, symptoms return with same severity Monday, May 3rd 2:15am, took 3 (20mg) Prednisone pills and 1 (25mg) Hydroxyzine pill as prescribed. Finally started working 6am, took another Hydroxyzine noon. Rash partly itchy and partly "erythema marginatum", went to Urgent Care 3pm, 4pm giving shot in hip of Kenalog, 8:30 now covered extensively with not itchy all blotchy spots. Went to ER 9pm - Tues 5/4 4:45am. Extensive blood test to rule out any infectious bacterial causes. Elevated white blood cell count appears related to multiple doses of steroids and the cause of the completely "erythema marginatum" non itchy blotches. Sent home to continue prednisone rx, stop Hydroxyine, resume Benadryl (25mg) 1 every 4 hrs until symptoms resolve.
47 2021-05-04 lymph node pain, swelling face After the second dose I felt nausea, fatigue and had enlarged tonsils and a sore throat. After 24 ho... Read more
After the second dose I felt nausea, fatigue and had enlarged tonsils and a sore throat. After 24 hours I felt better but with a lingering earache and tonsil pain, mostly on right tonsil. Then, about 48 hours later, the lymph node in my lower right cheek, close to the ear, had an "event." It felt like an "explosion" in my cheek. It was visibly swollen and I was then unable to eat for the next 24 hours. Severe pain in lymph node and an ear ache. I also felt like I had a "raisin" stuck in my throat. Symptoms have improved but there is still a visible bump on one tonsil with some lingering ear and throat pain. It's concerning to me.
47 2021-05-04 swelling face fainted; weak; tired; itching; trouble breathing; face swelling; unstable vital signs; This is a spo... Read more
fainted; weak; tired; itching; trouble breathing; face swelling; unstable vital signs; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration, administered in left arm on 05Apr2021 10:00 as single dose for covid-19 immunisation. Medical history included hypothyroidism, high cholesterol, allergies to penicillin and shell seafood. here were no concomitant medications. The patient previously took Percocet [oxycodone hydrochloride;paracetamol] and experienced allergies. The patient experienced fainted, weak, tired, itching, trouble breathing, face swelling and unstable vital signs on 05Apr2021 21:30. The patient was hospitalized. It was unknown if the patient received any treatment. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
47 2021-05-05 herpes virus infection A vice like head pain that hasn't gone away. Makes thinking hard, light sensitive and exhaustion. Ad... Read more
A vice like head pain that hasn't gone away. Makes thinking hard, light sensitive and exhaustion. Advil doesn't help. Feels like my brain is swollen and I can't think. I wake up with it, nothing changes the feeling. Massive herpes outbreak. Haven't had one in 2 years. Angry and emotional when I wasn't feeling this way before hand. Exhausted, sleeping 12-14 hours a day with naps in between. Extreme lethargy.
47 2021-05-05 herpes virus infection 51 hours after receiving the 2nd Pfizer vaccine does, I began to experience pain severe in my vagina... Read more
51 hours after receiving the 2nd Pfizer vaccine does, I began to experience pain severe in my vaginal area. This pain grew into an ulcer type of sore. I visited three doctors, was tested once for a yeast infection and twice for herpes. All three labs results were negative, while a minor strep B growth was identified. The area grew more severely painful over the course of 10 days, then it slowly began to resolve. After 17 days, the pain has gone and the site has almost completely resolved itself. I am taking penicillin to address the strep.
47 2021-05-05 lymph node swelling, lymph node pain Extreme swollen and painful lymph nodes in neck and underarm on injection side, continuing to increa... Read more
Extreme swollen and painful lymph nodes in neck and underarm on injection side, continuing to increase in size
47 2021-05-06 peripheral swelling I received my second vaccine by Pfizer on 04/21/2021. I had a severely red and swollen arm for about... Read more
I received my second vaccine by Pfizer on 04/21/2021. I had a severely red and swollen arm for about 5 days. I then seemingly recovered. 4 days ago, I work with my entire body covered in red rash with uneven borders. It is focused on my left leg, less on my right leg and a few rash patches on my chest and back.
47 2021-05-06 peripheral swelling Chills, fever over 102.5, body aches, joint pain, severe headache, nausea, whole body aches, pain an... Read more
Chills, fever over 102.5, body aches, joint pain, severe headache, nausea, whole body aches, pain and swelling in arm
47 2021-05-06 swelling face PATIENT RECEIVED COVID VACCINE FROM US AND CAME IN THE FOLLOWING EVENING WITH A SWOLLEN FACE. SHE W... Read more
PATIENT RECEIVED COVID VACCINE FROM US AND CAME IN THE FOLLOWING EVENING WITH A SWOLLEN FACE. SHE WAS GIVEN BENADRYL AND STATED SHE WOULD LET US KNOW IF IT DIDN'T HELP OR HER CONDITION WORSENED
47 2021-05-06 white blood cell count increased, lymph node swelling Fever, lymphadenopathy, diffuse bullous rash, admitted to hospital, other diagnoses ruled out with l... Read more
Fever, lymphadenopathy, diffuse bullous rash, admitted to hospital, other diagnoses ruled out with lab studies and skin biopsy.
47 2021-05-07 lymph node pain, lymph node swelling Large swollen lymph nodes under left arm Very painful and visible
47 2021-05-08 lymph node swelling, swollen extremities Lymph node in left arm pit is swollen
47 2021-05-08 lymph node swelling Generally feelings of unwellness, headache, body aches, sharp shooting pain in joints, shaking, swol... Read more
Generally feelings of unwellness, headache, body aches, sharp shooting pain in joints, shaking, swollen lymph nodes in neck, nausea, significant pain and warmth at injection site
47 2021-05-09 swelling Was sick when I woke up the next morning with the second shot. Thursday evening I started having a w... Read more
Was sick when I woke up the next morning with the second shot. Thursday evening I started having a weird feeling on my left side woke up Friday with a rash on my left side torso. Little bumps on my lower back.
47 2021-05-11 swelling 03-25-21 First Dose. Within 15 minutes I had a headache, lasted 24 hours. Sore arm for 1 week. 04/15... Read more
03-25-21 First Dose. Within 15 minutes I had a headache, lasted 24 hours. Sore arm for 1 week. 04/15/21 Second Dose. Within 15 minutes I had a headache, lasted until05/07/21. Nausea, chills, low grade fever, diarrhea, pain in lower back, overall body pain and swelling, rapid heartbeat, malaise, exhaustion and easily out of breath. These symptoms would come and go over the next 4 weeks. 04/28/21, I left work early I was so sick. 04/29/21 tested negative for Covid. 05/01/21 my right eye swelled, outward pressure, painful, jelly like whites of eye and red. ER trip eye is healthy, CT scan clear (concern because I had this continual headache), prescribed allergy drops that didn't work and prednisone. Prednisone helped with my eye and overall body pain and swelling decreased, headache remained, and eye still had issues but not as bad. Eye, body inflammation and pain increased once prednisone wore off. 05/04/21 Ophthalmology exam. Eye is healthy, swelling believed to be from Covid vaccine causing system wide inflammation. Eye drops prescribed Neomycin, Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, 4 X's a day. 05/06/21 Ophthalmology exam. Eye is still healthy, headache has lessened, but other symptoms still remain. Drops increased to Every 2 hours. 05/10/21 finally able to return to work. It was hard to get through the day. I had been able to take two-to-four-hour naps when needed in addition to sleeping at night, so not being able to rest when needed is difficult. 05/11/21, much better day. Still using medication and taking Naproxen to help with inflammation and headache.
47 2021-05-12 lymph node swelling Swollen lymph nodes in the lower superficial cervical and supraclavicular area on the right side, sw... Read more
Swollen lymph nodes in the lower superficial cervical and supraclavicular area on the right side, swelling went away after 8 days. Small amount of red pinpoint dots on both lower legs, which did not worsen and went away after 2 days.
47 2021-05-12 peripheral swelling Left arm swelling redness, itching and rash
47 2021-05-12 swelling face Facial Swelling (Eyes,Lips,cheeks), itching, swelling wheal, redness on face, chest, neck, arm pain ... Read more
Facial Swelling (Eyes,Lips,cheeks), itching, swelling wheal, redness on face, chest, neck, arm pain at injection site, period flowing hard(came early), arm numbness, feeling like something running up my neck, felt weird right after, throat swollen, headaches, and fatigue.
47 2021-05-14 lymph node swelling swollen lymph nodes, bad rash in breasts; bad rash in breasts; This is a spontaneous report from a c... Read more
swollen lymph nodes, bad rash in breasts; bad rash in breasts; This is a spontaneous report from a contactable consumer. This 47-year-old Female consumer (patient) reported that she received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 05Apr2021 13:15 (Batch/Lot Number: ER8727) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine includes Covid-19 immunization first dose (lot number: EN6208) administered in left arm on 15Mar2021. On 07Apr2021 the patient experienced swollen lymph nodes and bad rash in breasts. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
47 2021-05-16 lymph node swelling I received my first dose of COVID and within a couple days, I had swelling of the lymph node under m... Read more
I received my first dose of COVID and within a couple days, I had swelling of the lymph node under my armpit. I assumed this was an immune response. I became very ill. I consulted my doctor who then told me to go ahead and get the second shot. I got the second shot 4/16/2021. Within a few days I had several lymph nodes throughout my body swell. Since the second shot, they have not gone down and continue to get larger and larger with more problematic areas arising. . I am unable to walk correctly due to the ones on my groin region being so painful. It has been over a month since I got the vaccine and no relief in sight. I have had a headache that escalates to a migraine since.
47 2021-05-16 swollen extremities Received shot on Friday and on Sunday felt and noticed small pocket of swelling in left armpit.
47 2021-05-17 lymph node pain, lymph node inflammation Severe inflammation and pain in left axillary lymphs; Severe inflammation and pain in left axillary ... Read more
Severe inflammation and pain in left axillary lymphs; Severe inflammation and pain in left axillary lymphs; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: unknown, via unspecified route, in left arm on 21Apr2021 15:30 (at 47-years age) 1ST DOSE SINGLE for covid-19 immunisation. The patient's medical history included Migraines, past drug advil. The patient's concomitant medications included vitamin D, zinc, magnesio in within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications in 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021 the patient had experienced severe inflammation and pain in left axillary lymphs. The outcome of the event was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
47 2021-05-18 swelling, anaphylactic reaction Anaphylaxis; Vocal cord tightened; immediate severe headache on left half; tongue swelling; tingling... Read more
Anaphylaxis; Vocal cord tightened; immediate severe headache on left half; tongue swelling; tingling across face just above upper lip; face and neck turned red and swollen/ arms turned red under sleeves; face and neck turned red and swollen; dizzy; brain fog; Existing Tinnitus in left ear is louder; This is a spontaneous report from a contactable consumer reported for herself. This 47-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27Apr2021 15:15 (Batch/Lot Number: Unknown) as single dose (at 47 years old) for COVID-19 immunisation. Medical history included fibromyalgia from (previously diagnosed as Rheumatoid Arthritis). Concomitant medications included fenofibrate, escitalopram, hydrochlorothiazide, losartan potassium (LOSARTAN/HCT), herbal sup, all taken for an unspecified indication, start and stop date were not reported. The patient previously took monosodium glutamate and experienced allergy, hydroxychloroquine sulfate and experienced allergy. On 27Apr2021 15:15, the patient experienced anaphylaxis, vocal cord tightened, immediate severe headache on left half, tongue swelling, tingling across face just above upper lip, face and neck turned red and swollen/ arms turned red under sleeves, dizzy, brain fog, existing tinnitus in left ear is louder, all with outcome of not recovered (as reported). Therapeutic measures were taken as a result of the events included Diphenhydramine, Epinephrine, Famotidine, Zofran. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient stated that: "Sent to ER via ambulance: Diagnosed with Anaphylaxis. Vocal cord tightened, immediate severe headache on left half, tongue swelling, tingling across face just above upper lip, face and neck turned red and swollen, arms turned red under sleeves, dizzy, brain fog. Existing Tinnitus in left ear is louder, and as of 04May2021, I still have the headache". Seriousness criteria of the events was reported as serious due to disability. The information on the Lot / Batch number has been requested.
47 2021-05-18 white blood cell count increased rash, palpitatins, throat tightness, SOB -> treated with iv steroids and Pepcid/Benadryl. she was gi... Read more
rash, palpitatins, throat tightness, SOB -> treated with iv steroids and Pepcid/Benadryl. she was given epipen in the field. evaluated in the ER and admitted for monitoring
47 2021-05-19 oral herpes diagnosed with COVID; diagnosed with COVID; Nausea; large cold sore on lip and a canker sore on the ... Read more
diagnosed with COVID; diagnosed with COVID; Nausea; large cold sore on lip and a canker sore on the roof of the mouth; large cold sore on lip and a canker sore on the roof of the mouth; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 13Apr2021 at 16:30 (Batch/Lot Number: ER8731) at 47-years-old as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks of the suspect vaccine. Medical history included COVID-19 from an unknown date and unknown if ongoing (also reported as none and if COVID prior vaccination: No). The patient had no known allergies. There were no concomitant medications. On 13Apr2021 at 20:30, the patient experienced: large cold sore on lip and a canker sore on the roof of the mouth (non-serious). On 18Apr2021 at 09:00, the patient experienced: nausea (non-serious). On 05May2021, the patient was diagnosed with COVID (medically significant). The events, large cold sore on lip and a canker sore on the roof of the mouth and nausea, required a physician office visit; however, no therapeutic measures were received. The clinical course was reported as follows: Four hours after the injection, the patient developed a large cold sore on her lip and a canker sore on the roof of her mouth. On 18Apr2021 at 09:00 (also reported as five days later), the patient began experiencing nausea that she was still experiencing 18 days later. The patient was then diagnosed with COVID on 05May2021. The patient underwent lab tests and procedures which included Qualitative PCR (Nasal Swab): positive on 05May2021. The clinical outcome of the events: large cold sore on lip and a canker sore on the roof of the mouth and nausea, was not recovered. The clinical outcome of the event, diagnosed with COVID, was unknown.
47 2021-05-20 peripheral swelling pt got headache @ 3 AM after second dose followed by swollen fingers on vaccine side. Next day - 05... Read more
pt got headache @ 3 AM after second dose followed by swollen fingers on vaccine side. Next day - 052121 - pt reported pressure in lungs (only when breathing in and out using full force) - during working hours. pt using homeopathic remedies currently - states they are helping
47 2021-05-21 swelling Slight pain in right back of throat; Looked like Marge Simpson, felt like Novocaine numbing; Hives o... Read more
Slight pain in right back of throat; Looked like Marge Simpson, felt like Novocaine numbing; Hives on arms, legs, thighs, hips with lots of itching; Hives on arms, legs, thighs, hips with lots of itching; Nose and Upper Lip Angioedema; Right Eye puffy, closed, puckered, creased; Right Eye puffy, closed, puckered, creased; Right Eye puffy, closed, puckered, creased; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:15 (Lot Number: EW0153) as single dose for COVID-19 immunisation. Medical history included seasonal allergies to pollen, grasses, weeds. The patient's concomitant medications were not reported. On 26Apr2021, the patient experienced right eye puffy, closed, puckered, creased, on 01May2021, nose and upper lip angioedema, felt like Novocaine numbing; hives on arms, legs, thighs, hips with lots of itching, on 04May2021, lower Lip Angioedema on right side, looked like an asymmetrical fat lip; continued Hives on arms, legs, thighs, hips with lots of itching, on 07May2021, left eye puffy, closed, puckered, creased; continued hives on arms, legs, thighs, hips with lots of itching. slight pain in right back of throat. The patient did not receive any treatment for events. The outcome of events was recovering. Information on lot/batch number has requested.
47 2021-05-23 lymph node swelling, lymph node pain Swollen lymph node near left clavicle, tender and painful to the touch. Lessening but still present... Read more
Swollen lymph node near left clavicle, tender and painful to the touch. Lessening but still present at 1 week post vaccine.
47 2021-05-24 lymph node swelling pain in the injection site for few days; pain starts to increase in my arm and radiate down to my ar... Read more
pain in the injection site for few days; pain starts to increase in my arm and radiate down to my armpit; swollen lymph nodes; felling of unwell; sever muscle pain; redness/redness on the right side of the breast; pain starts to increase in my arm and radiate down to my armpit; This is a spontaneous report from a contactable consumer. A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 9269), via an unspecified route of administration, on 07Feb2021 at 14:00 (at the age of 47-year-old), as 1st dose, single for COVID-19 immunisation. The patient's medical history included thyroid issue. Patient had no known allergies. Concomitant medication in two weeks included levothyroxine. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Feb2021, at 14:30, 30 minutes after vaccination, the patient experienced pain in the injection site, which lasted for few days. Pain started to increase in her arm and radiated down to her armpit, with swollen lymph nodes and redness. Patient experienced a felling of unwell, with sever muscle pain and the injection area was very painful. Patient had redness on the right side of the breast. Patient enquired about the outcome or treatment for this vaccine side effect. The clinical outcome of all the events was not recovered. No follow-up attempts are possible, information on batch numbers cannot be obtained.
47 2021-05-24 swelling left axilla swelling and tenderness; left axilla swelling and tenderness; pain at the injection site... Read more
left axilla swelling and tenderness; left axilla swelling and tenderness; pain at the injection site; throat closing; This is a spontaneous report from a contactable physician (Patient, Self-reported). A 47-years-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an intramuscular, administered in left arm on 06Jan2021 12:00 as 1st dose, single and dose 2, (Batch/Lot number was not reported), in Arm Left, on 27Jan2021 for covid-19 immunisation. Medical history included patient was infected with covid back in April2020, neoplasm malignant (patient scared I might have had breast cancer at the time, as there is family hx of cancer). The patient previously took acetylsalicylic acid and experienced hypersensitivity, lactose and experienced hypersensitivity, lactose and experienced reaction to excipient. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination and did not receive Other medications in two weeks of vaccinations. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination.Reportedly, left axilla swelling and tenderness 4 days after the 1st injection with pain at the injection site. (she scared might have had breast cancer at the time, as there was family history of cancer). Repeatedly swelling and pain to the left arm occurred less than 1 day after the 2nd injection. Concerned of the hot flashes and disturbed sleep consistent to the time when she was infected with covid back in April 2020. One more thing, slight feeling of throat closing both times with the injections. With the first injection occurred 3-4 days afterwards with no SOB. With the second injection it occurred the within 24 hrs. On 10Jan2021 22:00, the patient experienced left axilla swelling and tenderness, pain at the injection site and throat closing. Treatment was not received for the adverse events. The patient underwent lab tests and procedures which included COVID-19 (sars-cov-2) test was negative on 08Jan2021. Outcome of the events was recovering. Information about Batch/Lot number has been requested Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
47 2021-05-25 lymph node swelling, fluid retention Pt said after first dose lymph under arm felt swollen and experienced swelling. After receiving 2nd ... Read more
Pt said after first dose lymph under arm felt swollen and experienced swelling. After receiving 2nd dose 2 weeks later she said her lymph system "blew up". She was in immense pain, had fluid retention and developed fluid blisters, experienced vision impairment and oil glands clogged in eyes, migraines, hair is falling out and fatigue. Patient said doctor gave her high dose steroids. She is still being treated by doctor for this. Still having multiple symptoms and trying to get them under control.
47 2021-05-25 peripheral swelling Patient reports swollen knot in arm that is tender and Fatigue greater that 1 week.
47 2021-05-26 axillary mass, swelling Severe swollen underarm with under arm pain lasted a week. Swelling on the side of the neck started ... Read more
Severe swollen underarm with under arm pain lasted a week. Swelling on the side of the neck started a few days later and is still there. Swelling in arm pit is down but can still feel lumps in my arm pit and new lumps on my bicep all on the injection side of the body.
47 2021-05-26 swelling Severe pain, swelling and redness, headache, muscle and joint pain, diarrhea, and fatigue, lasting ... Read more
Severe pain, swelling and redness, headache, muscle and joint pain, diarrhea, and fatigue, lasting 1 week+ after vaccination. Used ibuprofen, acetaminophen, and Benadryl for symptoms but they still persisted. All symptoms are tapering off but continue over this last week.
47 2021-05-27 peripheral swelling Hands and feet felt like the were on fire, swollen, and cold all at the same time. No fever present.... Read more
Hands and feet felt like the were on fire, swollen, and cold all at the same time. No fever present. Symptoms lasted 8 hours and since that date of onset, tingling in hands has been reoccurring at nighttime.
47 2021-05-28 lymph node swelling Swollen hot painful gland (i guess)!left side of neck starting at collar bone area going up. Seems m... Read more
Swollen hot painful gland (i guess)!left side of neck starting at collar bone area going up. Seems more fluid filled than hard lump.
47 2021-05-28 swelling face, peripheral swelling Rash, severe itching in head, face, joints, back, extremities, and eyes. Swelling on the face , hand... Read more
Rash, severe itching in head, face, joints, back, extremities, and eyes. Swelling on the face , hands, feet, and joints
47 2021-05-28 swelling, swelling face facial swelling( Eyes,Lips,Cheek); Itching; swelling wheal; redness on face/chest /neck; arm pain at... Read more
facial swelling( Eyes,Lips,Cheek); Itching; swelling wheal; redness on face/chest /neck; arm pain at injection site; menstrual period flowing hard (came early); menstrual period flowing hard (came early); arm numbness; feeling like something running up my neck; dizzy; throat swollen; headaches; felt weird right after; fatigue; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered on left arm on 07May2021 12:45 (Batch/Lot Number: EW0169) as 1st dose, single dose (at the age of 47 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced facial swelling( Eyes,Lips,Cheek), Itching, swelling wheal, redness on face, chest, neck, arm pain at injection site, menstrual period flowing hard (came early), arm numbness, feeling like something running up my neck, dizzy, felt weird right after, throat swollen, headaches and fatigue on 07May2021. The patient received treatment: steriods/ stomach anticid, antihistamine. Prior to vaccination, patient was not diagnosed with COVID-19 and not been tested for COVID-19. The patient had emergency department visit. The outcome of the events was recovering.
47 2021-06-01 swelling face Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Fa... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Pt stated her tongue felt funny a little tingly-Mild, Additional Details: Pt refused 911. stated her tongue felt a little numb and "funny." but not swollen just different feeling
47 2021-06-03 peripheral swelling had a very dry mouth; some swelled and itchy hives on the back of my legs; some swelled and itchy hi... Read more
had a very dry mouth; some swelled and itchy hives on the back of my legs; some swelled and itchy hives on the back of my legs; some swelled and itchy hives on the back of my legs; chills; I was getting sick; hot; clammy; This is a spontaneous report from a contactable consumer (Patient). A 47-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 6n6199 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 01Mar2021 15:45, as single dose for COVID-19 immunization. Patient's medical history included asthma, pneumonia, tuberculosis, whooping Cough and allergy to milk. Concomitant medications include Zyrtec, Magnesium, Calcium all taken for unspecified indications. The patient previously took vaccine for Pneumonia via an unspecified route of administration, administered in left arm, vaccine for tuberculosis and whooping cough via an unspecified route of administration, administered in right arm on 18Feb2021. The patient did not had COVID prior vaccination and was not COVID tested post vaccination. On 01Mar2021 08:00 pm, the patient started experiencing some swelled and itchy hives on back of legs, had very dry mouth since getting it (it's been 5 days). On an unknown date in Mar2021, the patient also began to feel like she was getting sick (but 5 days afterward), began to have chills, then hot and clammy. Therapeutic measures were taken as a result of chills, hot and clammy and patient was treated with Tylenol. The outcome of the events was reported as not resolved. No follow-up attempts are possible. No further information is expected.
47 2021-06-05 swelling Localized swelling and a rash with itch. Area feels hot to the touch. There was an initial reaction ... Read more
Localized swelling and a rash with itch. Area feels hot to the touch. There was an initial reaction the day of the shot that faded after a few days, however the reaction returned in the exact same spot 12 days after the shot.
47 2021-06-06 lymph node swelling 1. low fever, body ache, and swollen and enlarged lymph nodes on the right side after 12 hours of se... Read more
1. low fever, body ache, and swollen and enlarged lymph nodes on the right side after 12 hours of second needle 2. took one Tylenol and then the fever and ache gone but one enlarged lymph node at right neck area still show after 4 weeks 3. went to see doctor when 3 weeks pass
47 2021-06-08 herpes virus infection Herpes outbreak 4 days after injection; This is a spontaneous report from a contactable other health... Read more
Herpes outbreak 4 days after injection; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: unknown), dose 2 via an unspecified route of administration on 06Apr2021 at 13:30 (at the age of 47-years) and dose 1 via an unspecified route of administration on 16Mar2021 at 10:30 (at the age of 47-years), both as single dose in left arm for COVID-19 immunization. The patient's medical history included Herpes, systemic scleroderma, hypothyroidism and allergic to seafood, mango, other various intolerances (start date and ongoing status was unknown). The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 20Mar2021 at 16:00, four days after first injection, the patient experienced herpes outbreak. The patient has not had an outbreak in over 5 years. It was unknown if patient received any treatment for herpes and outcome reported as not resolved. On 12Apr2021 at 18:00, six days after second injection, she again had a herpes outbreak and received treatment with Valacyclovir. Since the vaccination the patient had not been tested for COVID-19. The outcome of event was resolving. No follow-up attempts were Possible. Information on lot/batch could not be obtained.
47 2021-06-09 axillary mass 01/17/2021 I woke up around 5 and I have cold and chills, it took about 3 days to go away then I wok... Read more
01/17/2021 I woke up around 5 and I have cold and chills, it took about 3 days to go away then I woke up with a large lump in my arm pit and breast- left side. It was very painful, I went to ER.
47 2021-06-10 c-reactive protein increased Flare-up of Ulcerative Colitis - started 4 days after 1st shot. Got worse immediately after 2nd shot... Read more
Flare-up of Ulcerative Colitis - started 4 days after 1st shot. Got worse immediately after 2nd shot. Diarrhea, extreme bloating, gas trapped in GI tract, inflammation of GI tract. Extreme abdominal cramping. GI dr confirmed generalized small-bowel dysmotility as a consequence of the vaccine. Also confirmed mild flare of Ulcerative Colitis and was given Prednisone as treatment. Also 1 week after vaccine developed sharp pain in lower back left side of skull, could not turn head. Went to neurologist, diagnosed with occiptal neuropathy and given nerve block injections to treat.
47 2021-06-11 anaphylactic reaction Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic:... Read more
Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Additional Details: Unsure what type of reaction she was experiencing. The agent from the state health department indicated patient was experiencing a severe reaction. The patient received a COVID and Tdap shot on the same day.
47 2021-06-11 swelling Intractable back pain; Couldnt walk; Stiffness; Herniated disk l4/l5; this vaccine caused swelling; ... Read more
Intractable back pain; Couldnt walk; Stiffness; Herniated disk l4/l5; this vaccine caused swelling; This is a spontaneous report from a contactable consumer (patient) A 47-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left (at the age of 47) on 21May2021 17:00 (Batch/Lot Number: EW0176) as single dose for covid-19 immunisation. Medical history included drug hypersensitivity to PNC, allopurinol (ELEVIL), cymbalta. No other vaccine was received in four weeks. Concomitant medications were received but not specified. The patient experienced intractable back pain on 21May2021 19:00, couldnt walk on 21May2021 19:00, stiffness on 25May2021, herniated disk l4/l5 on 21May2021 19:00, this vaccine caused swelling on 21May2021 19:00. The patient was hospitalized for 3 days for intractable back pain and couldnt walk. Patient received unspecified treatment. No Covid prior vaccination, or Covid tested post vaccination. The patient underwent lab tests and procedures which included magnetic resonance imaging: no underlying issues, herniated disk l4/l5 also a fracture of her hip. The events outcome was not recovered.
47 2021-06-13 lymph node swelling 1 month after second Pfizer mRNA vaccine for Covid-19, patient developed severe diffuse lymphadenopa... Read more
1 month after second Pfizer mRNA vaccine for Covid-19, patient developed severe diffuse lymphadenopathy involving cervical, supraclavicular and axillary chains, so severe that she has developed some cutaneous bruising in axillary area and symptoms suggesting brachial plexus compression. Lymphadenopathy is bilateral
47 2021-06-16 anaphylactic reaction Suspected anaphylactic reaction managed with epinephrine, solumedrol, Benadryl
47 2021-06-16 lymph node swelling Lymph node sweilling near collar bone. Hives on chest under swollen lymph node. Left side. Lasted 4 ... Read more
Lymph node sweilling near collar bone. Hives on chest under swollen lymph node. Left side. Lasted 4 days so far.
47 2021-06-16 peripheral swelling From bottom of my knees all down its swollen; This is a spontaneous report received from a contactab... Read more
From bottom of my knees all down its swollen; This is a spontaneous report received from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EW0202 and expiration date: not reported), via an unspecified route of administration, on Left arm on 09Jun2021 between 08:30 - 09:00 (at the age of 47-year-old), as 1ST DOSE, SINGLE DOSE, for covid-19 immunization in the emergency room in the clinic. Medical history included diabetes mellitus. The patient had no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The patient stated that from bottom of her knees all down its swollen on 09Jun2021 at 05:48 (as reported).The patient would like to know long will this last. The Patient didn't take any treatment however it was also reported that all she had was some grapefruit juice, and Kool-Aid and had some rice. The outcome of the event is unknown.
47 2021-06-20 swelling, peripheral swelling Rash, bumps on neck, arms, legs
47 2021-06-21 peripheral swelling Deep vein thrombosis left leg, Lovenox f/by Pradexa. On 5/28/21, received pfizer covid vaccine 2nd d... Read more
Deep vein thrombosis left leg, Lovenox f/by Pradexa. On 5/28/21, received pfizer covid vaccine 2nd dose. On 5/29, visited . on 6/1/21, noted Lf leg pain. 10 days later, noted severe pain and swelling. ED visit on 6/11/21
47 2021-06-21 swelling face I was in the store right after my vaccine dose and the lights seemed like they were dimming, then re... Read more
I was in the store right after my vaccine dose and the lights seemed like they were dimming, then really bright, so I asked an employee and she said no that they were not doing anything with the lights, and saw her face was swollen. She went to the pharmacy at the store and got Benadryl, Tongue was swollen also by the time they got the to ER and the ER gave her Kalkenalong-40 for the swelling. I woke up at 2am the next morning and my feet and palms were so itchy, and took more Benadryl. The next day, I did not have any more reactions, and the swelling had gone down. The ER prescribed prednisone, but I didn't take it.
47 2021-06-22 anaphylactic reaction History is provided by the patient. This is a 47 year old female with self reported past medical his... Read more
History is provided by the patient. This is a 47 year old female with self reported past medical history of nephrolithiasis who presents to the ED with concerns for allergic reaction. Received second dose of the COVID vaccine around 08:00 am this morning. About 20 minutes later, she started to feel constant shortness of breath in addition to feeling like she was going to pass out with associated nausea and tingling to her hands and feet. No modifying factors reported. She presented to the ED for further evaluation. She had a similar reaction on receiving her first dose of the COVID vaccine, but notes this episode feels worse. Lungs are clear to auscultation. No signs of angioedema. No clinical signs of an allergic reaction. Due to patient's complaints, will provide Solu-Medrol, Benadryl, and famotidine. Will also obtain EKG. Discussed indications for epinephrine, will hold off epinephrine at this time and re-assess. 09:33- On re-assessment, patient now with periorbital edema. Airway still intact and voice is clear. However, will provide epinephrine now. The patient was treated with intravenous fluids (IVFs) for the following reason: concerns for dehydration, dry mucous membranes. Patient improved after IV fluid administration. Patient is reassessed multiple times, with improving symptoms At 4 hours status post epinephrine, patient with no rebound symptoms, patient states that she is feeling better, ready for discharge home. Due to anaphylaxis, will provide additional epinephrine prescription for home. Allergy added to patient chart.
47 2021-06-22 axillary mass I developed a lump/swelling in my right underarm. The lump disappeared about 3-4 days later without ... Read more
I developed a lump/swelling in my right underarm. The lump disappeared about 3-4 days later without incident.
47 2021-06-22 peripheral swelling Later that afternoon I felt like a ton of bricks hit me. Almost like I was going to faint. When I go... Read more
Later that afternoon I felt like a ton of bricks hit me. Almost like I was going to faint. When I got home my arm was swollen and red. I started having a bad bowel movement, no fever, stiffness, joints aching, and dull aches. I had a hard time resting. The next day when I woke up, I had a bowel movement bad. When I went downstairs, I was bleeding from light to medium from my vagina. For 4 hours I had sharp pains in the middle of my chest. I went to see Doctor; my symptoms were gone for 5 days. Then 10 days ago my eyes were tearing a lot and painful. I went walking and had incredible pain in feet, ankle, knee, and I could barely stand. The next morning, I went to my PCP and referred me to a RA doctor and think it's an autoimmune disease.
47 2021-06-25 peripheral swelling Myocarditis; breathing issues; chest pain; muscle aches; chills; left leg swelling; fatigue; This is... Read more
Myocarditis; breathing issues; chest pain; muscle aches; chills; left leg swelling; fatigue; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 47-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0177), dose 2 via an unspecified route of administration, administered in Arm Right on 18May2021 12:00 (at the age of 47-years-old) as dose 2, single for covid-19 immunisation. Medical history included High blood pressure, asthma, allergy to animal (allergies :Cats). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient did not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Concomitant medications included lisinopril. Patient took 1st dose of bnt162b2 (Batch/Lot Number: Ew0175), administered in Arm Left on 22Apr2021 12:15 for covid-19 immunisation. On 19May2021 01:00, the patient experienced myocarditis, chest pain, muscle aches, chills, left leg swelling, breathing issues and fatigue. The event myocarditis was serious. Patient visited Doctor or other healthcare professional office/clinic visit for adverse events. No treatment received for adverse events. Outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
47 2021-06-29 lymph node swelling mouth dryness; lymph nodes swollen; rash on face, arms, torso, backand thighs; This is a spontaneous... Read more
mouth dryness; lymph nodes swollen; rash on face, arms, torso, backand thighs; This is a spontaneous report received from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247) via an unspecified route of administration in left arm on 11Mar2021 at 11:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication includes unspecified vitamins (MANUFACTURER UNKNOWN) and biotin (MANUFACTURER UNKNOWN) taken for unspecified indication from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 17Mar2021, the patient experienced mouth dryness, lymph nodes swollen and rash on face, arms, torso, back and thighs. At the time of this report (since 5 days), the events were still persisting. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with ZYRTEC for rash and dry mouth. The clinical outcome of the events mouth dryness, lymph nodes swollen and rash on face, arms, torso, back and thighs were not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
47 2021-06-29 lymph node swelling swollen lymph node under right arm; This is a spontaneous report from a contactable Other HCP (patie... Read more
swollen lymph node under right arm; This is a spontaneous report from a contactable Other HCP (patient). A 47-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264), via an intramuscular route on 04Feb2021 at 16:00 (at the age of 47-years) as dose 2, single in the right arm for covid-19 immunisation. The patient medical history included RA, GERD. The patient had no known allergies. The patient concomitant medications included cyanocobalamin (B 12), calcium carbonate, colecalciferol (CALCIUM D3), celecoxib (CELEBREX), duloxetine hydrochloride (CYMBALTA), folic acid, methotrexate, montelukast sodium (SINGULAIR), multivitamin (not coded) from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL1285), via an intramuscular route on 14Jan2021 at 16:00 as dose 1, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Feb2021 at 18:30, the patient experienced swollen lymph node under right arm. The patient did not received treatment for event. The outcome of the event was not recovered. Follow-up (11May2021): Follow-up attempts completed. No further information expected.
47 2021-06-29 lymph node swelling Swollen Lymph Nodes under left armpit; This is a spontaneous report from a contactable consumer, the... Read more
Swollen Lymph Nodes under left armpit; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EN6206), via an unspecified route of administration in the left arm on 06Mar2021 at 15:15 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient was allergic to codeine (MANUFACTURER UNKNOWN). The concomitant medications included hydrochlorothiazide tabs 25mg (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C) and cholecalciferol (VITAMIN D3) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EL9266), via an unspecified route of administration in the left arm on 13Feb2021 at 15:15, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination, the patient had no symptoms associated for COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. On 07Mar2021, the patient had swollen lymph nodes under left armpit. The patient did not receive any treatment for reported events. The clinical outcome of swollen lymph nodes under left armpit was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
47 2021-06-29 peripheral swelling A couple of toes on both feet became painful, itchy and swollen; A couple of toes on both feet becam... Read more
A couple of toes on both feet became painful, itchy and swollen; A couple of toes on both feet became painful, itchy and swollen; A couple of toes on both feet became painful, itchy and swollen; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 47-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL9264 and Expiration date was not reported) via an unspecified route of administration, in right arm, on 01Feb2021 at 10:30 AM (at the age of 47-year-old), as a single dose for COVID-19 immunization.The patient medical history included drug hypersensitivity (Sulfa allergy) and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 02Feb2021, patient had experienced a couple of toes on both feet became painful, itchy and swollen interfering with sleep and wearing shoes. No treatment was received. The outcome of the events was not recovered. The seriousness for the events was reported as non-serious. Follow-up attempts are completed. No further information is expected.
47 2021-07-01 swelling severe burnt sensation on ceiling of mouth, indescribable entire jaws/teeth pain, itchiness, the mos... Read more
severe burnt sensation on ceiling of mouth, indescribable entire jaws/teeth pain, itchiness, the most severe migraine pain reaching level 100, intense severe tight neck, stiff neck, brain pressure, back of the head tightness, uncontrollable fatigue, lethargy, temple headache, ear clogging, severe inflammation type of swelling on right neck from 6/1/21 to present and ongoing, still sick as of 7/2/21.
47 2021-07-02 lymph node pain, lymph node swelling Swollen lymph nodes on right front/ side of neck; Very tender lymph nodes on right front/side of nec... Read more
Swollen lymph nodes on right front/ side of neck; Very tender lymph nodes on right front/side of neck; Facial flushing on third day; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via unspecified route of administration in right arm on 19Mar2021 at 09:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune thyroid. The patient had no allergies to medications, food, or other products, but she had issues breaking down histamine so environmental triggers could cause allergic-like reactions. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had taken other medication (unspecified) in two weeks, prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 and procedures included the Nasal Swab test in Dec2020, the result was negative. On 22Mar2021 at 09:30, the patient experienced facial flushing on third day and on 24Mar2021 the patient experienced swollen/ very tender lymph nodes on right front/side of neck on fifth day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had not received any treatment for the event. The clinical outcome of facial flushing, lymphadenopathy and lymph node tender were not recovered. No follow-up attempts are needed. No further information is expected.
47 2021-07-06 lymph node swelling headache; arm pain injection site; nausea; chills; fever the highest it ran was 103.5; severe inner... Read more
headache; arm pain injection site; nausea; chills; fever the highest it ran was 103.5; severe inner ear pain; eardrums were bulging on both sides and red; eardrums were bulging on both sides and red; I was completely exhausted zero strength could not tolerate light; my left eye was swollen; lymph nodes have swelled up all over my body in places that I did not even know I had lymph nodes that are very tender to touch.; Body aches especially in neck and head.; Body aches especially in neck and head.; This is a spontaneous report from a contactable consumer, other healthcare professional (the patient). A 47-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 17Mar2021 (at the age of 47-years-old) as a single dose for COVID-19 immunization. Medical history included polycystic ovaries, Known allergies Penicillin. Concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration ad-ministered in left arm on 26Feb2021 22:30 as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient had allergies with penicillin. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 05:00 pm, the patient had headache arm pain injection site nausea chills then fever the highest it ran was 103.5 lasting from Wednesday through Saturday. Causing severe inner ear pain went to urgent care they said her eardrums were bulging on both sides and red, she was completely exhausted zero strength could not tolerate light for 3 days her left eye was swollen and lymph nodes have swelled up all over her body in places that she did not even know she had lymph nodes that are very tender to touch. Body aches especially in neck and head. The adverse event resulted patient to emergency room/department or urgent care visit. The patient received treatment. They put her on Voltaren 75 mg for ear pain. Outcome of the event at the time of last observation was not recovered. Follow-up attempts are needed. Further information is requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
47 2021-07-06 white blood cell count increased Pt came to hospital with dizziness, headache and fever. Pt had extremely elevated D-dimer, and eleva... Read more
Pt came to hospital with dizziness, headache and fever. Pt had extremely elevated D-dimer, and elevated infection markers including procalcitonin. However, her workup for an infectious process was inconclusive. Vaccine related event is a possibility as no infection source was detected.
47 2021-07-08 lymph node swelling My father was with me and drove me over there. I got the shot. Around 12PM I started vomiting and I ... Read more
My father was with me and drove me over there. I got the shot. Around 12PM I started vomiting and I hadn't even ate anything, non-stop until two days ago. Diarrhea not able to keep anything down. My lymph nodes are swollen, my voice is very horse. Yesterday I was able to eat solid food very slowly. It reactivated my Epstein-Barre virus. I'm exhausted. From June 26th to July 7th those have been all my symptoms. On July 8th I was able to hold my food and water without throwing up but I still have diarrhea. I'm still fully activated with EBV and no disease doctor or primary doctor.
47 2021-07-08 peripheral swelling Has a strong pain in arm; The patient feels her arm is swollen; patient still doesn't have full rang... Read more
Has a strong pain in arm; The patient feels her arm is swollen; patient still doesn't have full range of motion in her arm; Had a fever 15 minutes after getting home, after receiving the first dose Pfizer Covid 19 Vaccine; This is a spontaneous report from a contactable Pharmacist. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Lot number: EW0181; Expiration Date: Aug2021) via an unspecified route of administration, administered in left arm on 15Jun2021 as dose 1, single for COVID-19 immunization (age at vaccination: 47 years). The patient's medical history and concomitant medications were not reported. On 15Jun2021, patient had fever 15 minutes after getting home, after receiving the first dose Pfizer Covid 19. On an unspecified date, patient experienced a strong pain in arm and felt her arm was swollen and the patient still did not have full range of motion in her arm. The patient was saying she cannot return to work. The patient took two Tylenol and the fever has continued since. Patient received the treatment for pain in arm and pyrexia, and outcome of this event was not resolved. The outcome of swollen arm and joint range of motion decreased was unknown. No further information was reported.
47 2021-07-08 swelling face Worst headache; bad bodyaches; fever; puffy face; This is a spontaneous report from a non-contactabl... Read more
Worst headache; bad bodyaches; fever; puffy face; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the right arm on 23Mar2021 at 18:15 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19, which was diagnosed prior to the vaccination. The patient did not have any allergies to medications, food, or other products. Concomitant medication included thyroid (ARMOUR THYROID) for unknown indication and from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. On 24Mar2021, the patient experienced worst headache, bad body aches, fever and puffy face. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event worst headache, bad body aches, fever and puffy face were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
47 2021-07-08 swelling red welts on right side of my face; Itchy; slight swelling; This is a spontaneous report from a cont... Read more
red welts on right side of my face; Itchy; slight swelling; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER2613) via an unspecified route of administration in the right arm on 23Mar2021 (at the age of 47-year-old) at 10:00 as a single dose for COVID-19 immunisation. Medical history included high blood pressure and diabetes. Concomitant medications included Pepcid (MANUFACTURER UNKNOWN), celexa (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNWON). The patient was allergic to codeine (MANUFACTURER UNKNOWN) and stadol (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 08:00, the patient experienced itchy, red welts on the right side of the face and slight swelling. No treatment was taken taken for the reported events. The clinical outcome of the events itchy, red welts on right side of the face and slight swelling were recovering at the time of report. No follow-up attempts possible. No further information expected.
47 2021-07-09 swelling face Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Hypertension-Medium, Sy... Read more
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: pt felt numb on left side of cheeck, then radiate as tingling sensation on tongue and lip. blood pressure was going up.
47 2021-07-10 lymph node swelling Vary swollen lymph node in neck; Hard lump at vaccination site; This is a spontaneous report from a ... Read more
Vary swollen lymph node in neck; Hard lump at vaccination site; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA vaccine; Lot number: EP7533) via an unspecified route of administration in the left arm on 25Mar2021 at 11:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. Concomitant medications included high blood pressure medicines (MANUFACTURER UNKNOWN), tramadol (MANUFACTURER UNKNOWN), me (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN); all from unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient experienced very swollen lymph nodes in the neck and hard lump at shot site and it was still same 3 days later. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events swollen lymph nodes in the neck and hard lump at shot site (vaccination site lump) were unknown. No follow-up attempts are needed. No further information is expected.
47 2021-07-11 lymph node swelling, lymph node pain I experienced pain and swelling of the lymph nodes in the right arm, nausea, loose stool, no energy... Read more
I experienced pain and swelling of the lymph nodes in the right arm, nausea, loose stool, no energy, body aches, and a low grade fever (101.0). I did not seek medical care and took Benadryl and Tylenol for my symptoms.
47 2021-07-12 lymph node swelling Swollen lymph nodes collarbone; This is a spontaneous report from a non-contactable consumer, the pa... Read more
Swollen lymph nodes collarbone; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration on an unknown date (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date, the patient experienced swollen lymph nodes collarbone. The clinical outcome of the event swollen lymph nodes collarbone was unknown at the time of this report. No follow-up attempts are possible. No further information is expected.
47 2021-07-12 peripheral swelling 6/30/21, 20 minutes after headache and fatigue. More tired that usual over next few days and hard to... Read more
6/30/21, 20 minutes after headache and fatigue. More tired that usual over next few days and hard to concentrate. 7/2/21-7/13/21 twitching in my legs upon waking (think activated bartonella bacteria from lyme co-infection), 7/3/21-7/8/21- circulation poor in lower legs-had to move around a lot, veins protruding from lower legs-which I've never had before and some swelling in ankles, feet and fingers, 7/1/21 heart beating fast going up flight of stairs but quickly went back to normal also got menstrual cycle 10 days early- was heavier with blood clots (typically 28 day cycle), bruise under area received vaccine
47 2021-07-12 swelling face Patient received vaccine at a Pharmacy. She immediately felt itchy but did not notice a rash or hive... Read more
Patient received vaccine at a Pharmacy. She immediately felt itchy but did not notice a rash or hives, 3.5 hours later she reported feeling SOB and chest heaviness. She also felt/feels achy, foggy, weird and with a swollen face and eyes. SOB and swelling are improving
47 2021-07-13 swelling face Received second dose of Pfizer vaccine at 5:29pm on July 14, 2021, at 5:42pm patient began to have f... Read more
Received second dose of Pfizer vaccine at 5:29pm on July 14, 2021, at 5:42pm patient began to have facial itching, cough, congestion, nasal itching, facial swelling, facial redness vitals taken BP 144/80, 98 O2 on room air, HR78, RR 22. 50 mg of Diphenhydramine hydrochloride given intramuscular to left deltoid. Patient reported relief of symptoms 7-10 minutes after administration. Vitals at 6:10pm 138/82, 98 Or on room air, HR 71, afebrile, 16 RR.
47 2021-07-13 swelling Red, swollen, hot to touch
47 2021-07-17 lymph node swelling, peripheral swelling Lymph node swollen in arm pit; Legs red swollen and heated.; Legs red swollen and heated.; This is a... Read more
Lymph node swollen in arm pit; Legs red swollen and heated.; Legs red swollen and heated.; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 23Mar2021 at 13:30 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy and COVID-19. Concomitant medication included escitalopram oxalate (LEXAPRO) from unknown date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021 at 12:00, the patient experienced lymph node swollen in arm pit, legs red swollen and heated. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swollen lymph nodes, swelling of legs and redness legs was not recovered at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
47 2021-07-17 swelling severe burning sensation of ceiling of mouth; severe pain on jaws/teeth; severe pain on jaws/teeth; ... Read more
severe burning sensation of ceiling of mouth; severe pain on jaws/teeth; severe pain on jaws/teeth; severe migraine; severe fatigue; lethargy; temple headache; severe tightness on the back of head; severe stiff neck; right ear clogging; swelling sensation of right neck; dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient) reporting on herself. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: EW0185) via an unspecified route of administration, administered in Arm Left on 15May2021 at 10:00 as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 24Apr2021 at 10:00 (Batch/Lot Number: EW0171) as both for covid-19 immunisation. Medical history included drug hypersensitivity allergies Sulfa group, Band aids, hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included acyclovir (400mg) taken for an unspecified indication, start and stop date were not reported. She was not diagnosed and tested Covid-19 prior vaccination. She was no pregnant at time of vaccination. On 01Jul2021 at 14:00 ,the patient experienced severe burning sensation of ceiling of mouth, severe pain on jaws/teeth, severe migraine, severe fatigue, temple headache, severe tightness on the back of head, severe stiff neck , right ear clogging, swelling sensation of right neck, dizziness. She went to emergency room. She was taken MethylPredisolone at two different times as a treatment for all events. Therapeutic measures were taken as a result of severe burning sensation of ceiling of mouth, severe pain on jaws/teeth, severe migraine, severe fatigue, lethargy, temple headache, severe tightness on the back of head, severe stiff neck, right ear clogging, swelling sensation of right neck, dizziness. The outcome of the events were not recovered. Follow-up attempts are possible. Further information is expected.
47 2021-07-18 peripheral swelling Felt as if needle was still inside of arm, arm felt heavy, light headed, dizziness, sore, warm , mus... Read more
Felt as if needle was still inside of arm, arm felt heavy, light headed, dizziness, sore, warm , muscle in arm hurt, looked like a big mosquito bight, swollen, itchy
47 2021-07-21 lymph node swelling Pfizer BioNTech's COVID-19 Vaccine: 24-hour fever and muscle pain. Nausea and dizziness at 40hrs. Sw... Read more
Pfizer BioNTech's COVID-19 Vaccine: 24-hour fever and muscle pain. Nausea and dizziness at 40hrs. Swollen lymph nodes under left armpit and left clavicle.
47 2021-07-21 swelling At the injection site, red circle a little larger than a dollar coin; Swelling; Intermittent itchy f... Read more
At the injection site, red circle a little larger than a dollar coin; Swelling; Intermittent itchy feeling; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any allergies to medications, food or other products. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN) and phendimetrazine (MANUFACTURER UNKNOWN); all from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the right arm on 09Mar2021 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced red circle a little larger than a dollar coin at the injection site, swelling and intermittent itchy feeling. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events red circle a little larger than a dollar coin at the injection site, swelling and intermittent itchy feeling were not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
47 2021-07-22 lymph node swelling generalized muscle and joint pain, extreme fatigue, shortness of breath, pain at insertion site, lym... Read more
generalized muscle and joint pain, extreme fatigue, shortness of breath, pain at insertion site, lymphadenopathy axillary and supraclavicular on site of infection, headache
47 2021-07-24 peripheral swelling I developed acute swelling of my knuckles, ankles and knees. Could not type or use hands properly fo... Read more
I developed acute swelling of my knuckles, ankles and knees. Could not type or use hands properly for 4 days. Also experienced intense pain in my side on July 3nd, requiring am ER visit. Was the site of former (5 years ago) shingles outbreak. Have had intense fatigue
47 2021-07-27 anaphylactic reaction anaphylaxis/allergic reaction; Mast Cell Activation Syndrome; Drug Hypersensitivity Syndrome; Intole... Read more
anaphylaxis/allergic reaction; Mast Cell Activation Syndrome; Drug Hypersensitivity Syndrome; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left at age of 47 years, not pregnant on 19Mar2021 14:00 (Lot Number: Pfizerep7534) as single dose for covid-19 immunisation. Medical history included allergies to penicillin prior to vaccine and traumatic brain injury from near fatal accident. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for birth control; fluticasone propionate (XHANCE). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had an anaphylaxis/allergic reaction to the first Covid Pfizer vaccine shot, (her only shot) on 19Mar2021 and since then things had spiraled out of control with her body; many medications to treat had caused more anaphylaxis allergic reactions like Benadryl, Cromolyn and Famotidine/Pepcid (7meds in total as she had been on no new meds since). She presented with Mast Cell Activation Syndrome and Drug Hypersensitivity Syndrome. 5 ER visits, 2 hospital stays and no improvements. The only medications that seem to provide any relief. Hydroxyzine, Singulair and Prednisone and even with these medications she continue to have allergic reactions or intolerances to medications which has now expanded to food, exertion, scents, and temperature changes. Not sure why this was happening, as prior to 19Mar2021 no food allergies and never had anaphylaxis until then. Patient in need of treatment by a vaccine expert. Her body saw everything as a toxin. Adverse event started at 19Mar2021, 14:00, and resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Hospitalization for 7 days. This case was serious with seriousness criteria reported as life threatening and caused hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid test via nasal swab on 12May2021 was negative. The outcome of the events was not recovered.
47 2021-07-27 peripheral swelling Left eye is swollen and painful and watery; Left eye is swollen and painful and watery; Left eye is ... Read more
Left eye is swollen and painful and watery; Left eye is swollen and painful and watery; Left eye is swollen and painful and watery; arm is swollen; feels hot to the touch; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old-non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 at 18:00 (at the age of 47-year-old) as a single dose for COVID -19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 02Apr2021 at 08:00, the patient's left eye was swollen and painful and watery. The patient's arm was swollen and felt hot to touch. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events left eye swollen and painful and watery, arm was swollen and felt hot to the touch were not recovered. No follow-up attempts are needed; information about lot number cannot be obtained.
47 2021-07-28 swelling AFTER RECEIVING THE PFIZER VACCINE ON MY WAY HOME AFTER 15 MINUTES I FELT A COUGH COMING ON THEN AFT... Read more
AFTER RECEIVING THE PFIZER VACCINE ON MY WAY HOME AFTER 15 MINUTES I FELT A COUGH COMING ON THEN AFTER I GO HOME I FELT WEIRD SO I SAT DOWN AND WAS JUST SITTING DOWN, AFTER ABOUT 3 HOURS HAD PASSED I COULDN'T EVEN WALK TO THE RESTROOM ON MY OWN, SO MY SON HAD TO TAKE ME, AFTER COMING OUT OF THE BATHROOM I WENT TO LAY DOWN ON THE BED AROUND 8PM, BY THEN I WAS SWELLING UP ALL OVER AND ITICHING AND FEELING HORRIBLE LIKE IF SOMETHNG WAS KEEPING DOWN, I WAS IN SO SO MY PAIN AND FELT MY LUNG SO TIGHT THE I WAS HAVING DIFFICULT BREATHING, THIS IS WHO I WAS ALL NIGHT, HAVING CHILLS AND ACHING EVERY INCH OF MY BODY, NEXT DAY I HAD TO GO INTO THE ER AND I WAS TOLD I HAD A ALLERGY REACTION TO THE PFIZER VACCINE AND RECOMMENDED I DON'T TAKE THE SECOND DOSE ON AUGUST 2, 2021, THEN AFTER THIS ER VISIT I HAD TO GO AGAIN ON THE 15 OF JULY AS I GOT WORSE AND WAS TOLD THE SAME ALLERGIC TO COVID 19 VACCINE
47 2021-07-29 lymph node swelling Lymph nodes swelling, inflammation lung, collaped lung, rash on face
47 2021-07-29 peripheral swelling Swelling to my lower body; Some pain; Itching; Diarrhea; Vomiting; Body sweats; This is a spontaneou... Read more
Swelling to my lower body; Some pain; Itching; Diarrhea; Vomiting; Body sweats; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0169, Expiration date not reported), via an unspecified route of administration, administered in arm right on 30Jun2021 at 13:00 (at the age of 47-year-old) as single dose for COVID-19 immunisation. Family medical history included colon cancer (Verbatim: mother colon cancer), cataract, high blood pressure and diabetes mellitus (Verbatim: Grandmother cataracts, high blood pressure, diabetes). The patient's medical history and concomitant medications were reported as none. Prior vaccinations were reported as none. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0202, Expiration date not reported), via an unspecified route of administration, administered in arm left on 09Jun2021 at 08:30 (at the age of 47-year-old) as single dose for COVID-19 immunisation and experienced from bottom of my knees all down its swollen. On an unspecified date, the consumer reported that she had a lot of swelling to her lower body, some pain, Itching, diarrhea, vomiting, body sweats, but all of this was after she took the Vaccine shots. Relevant tests were reported as none. The reporter classified the events as non-serious. The outcome of the events was unknown.
48 2021-01-01 lymph node swelling Woke up w/ primarily left sided cervical lymphadenopathy with gum pain/swelling on the left - onset ... Read more
Woke up w/ primarily left sided cervical lymphadenopathy with gum pain/swelling on the left - onset 12/27. Visit to dentist for worsening pain and mild body aches and chills - dentist felt the pain and swelling, + mild ulceration due to new toothbrush head causing abrasions on gums and hard palate - no treatment prescribed - 12/28. Worsening painful lymphadenopathy (now bilateral cervical), body aches, chills, joint pain, fevers, odynophagia, gum pain/swelling, malaise - visit to respiratory clinic - rapid strep negative; COVID negative, bacterial throat culture negative (VS: HR 120, SBP 168, T 100.7 on Tylenol) - no treatment prescribed - 12/29. Development of shallow, painful ulcers LEFT hard palate, gums and a RIGHT lip ulcer - 12/31. Photos of ulcers reviewed with previous dentist - prescribed acyclovir 400 mg TID and magic mouthwash. 12/31. Taking Ibuprofen and Tylenol regularly. As of today, 1/2, improvement in cervical lymphadenopathy, resolution of constitutional symptoms, and odynophagia. Ongoing mouth pain and ulceration. + left facial numbness/burning pain (V1-3) similar to previous episode of trigeminal neuralgia in 1999.
48 2021-01-03 lymph node swelling, lymph node pain Initially had arm pain in the left deltoid area with mild induration, chills and some bodyaches. Gen... Read more
Initially had arm pain in the left deltoid area with mild induration, chills and some bodyaches. Generalized fatigue. Two days ago(1/2/21) a large left supraclavicular lymph node came up, it is a little sore. No redness. Moveable. No coughing or SOB. No difficulty swallowing. No rash to that area. No sore throat or other known cause at this time for the adenopathy
48 2021-01-03 peripheral swelling, swollen extremities 26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreas... Read more
26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreased perfusion added bilateral knee joint pain; 25Dec2020 added facial edema; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; throat scratchy and tight; throat scratchy and tight; 23Dec2020 slight swelling on feet and ankles; 23Dec2020 slight swelling on feet and ankles; Tingling and best flutter 5 minutes after administration; Tingling and best flutter 5 minutes after administration; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number: EJ1685, expiration date: Mar2021), intramuscularly on 22Dec2020 at 09:45 at single dose for COVID-19 immunization in hospital. The patient medical history included known allergies: Sulfa, Penicillin; fibromyalgia; hypertension; high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications included other medications was received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced on 22Dec2020 09:45 tingling and best flutter 5 minutes after administration; 23Dec2020 slight swelling on feet and ankles; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen, throat scratchy and tight; 25Dec2020 added facial edema; 26Dec2020 continued decreased perfusion added bilateral knee joint pain. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included diphenhydramine hydrochloride (BENADRYL) 50 mg every 6 hours. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: Flutter occurred 5 minutes after vaccination; a possible causal association between administration of the suspect vaccine bnt162b2 and the serious event onset cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
48 2021-01-04 anaphylactic reaction Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: em... Read more
Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: employee with an adverse reaction to the Covid vaccination. Reported to RN 10 minutes post vaccination Lips numbness/ tingling, throat fullness and slightly anxious. NP assessed employee and 50mg of IM Benadryl given in the opposite arm (right). No SOB or wheezing noted. VS pre treatment 158/99, 98%-RA, 98-HR, 18-RR. Ten minutes post treatment Lip tingling and throat fullness improving. At 20 minutes post treatment all S&S of adverse reaction resolved VS taken throughout even with 60 minutes of observation time total VS 139/84, 99%-RA, 81-HR, 14-RR. She is feeling tired and will consider calling for a ride to go home as advised by staff.
48 2021-01-04 lymph node swelling Temp max 100.2F (tympanic thermometer); Chills; Body aches; Joint pain; Swollen cervical lymph nodes... Read more
Temp max 100.2F (tympanic thermometer); Chills; Body aches; Joint pain; Swollen cervical lymph nodes; Fatigue; This is a spontaneous report from a contactable nurse (patient herself). This 48-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unknown route, on 23Dec2020 at 11:30 AM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was not pregnant. Relevant medical history included well-controlled hypertension, gastrooesophageal reflux disease (GERD), seasonal allergies (pollen only) and well -controlled depression. Relevant concomitant medications included losartan, spironolactone, wellbutrin, omeprazole (PRILOSEC) and cetirizine hydrochloride (ZYRTEC). The patient was vaccinated at Workplace Clinic, age at vaccination was 48-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. On 24Dec2020 at 01:00 AM, the patient had temp max 100.2 F (tympanic thermometer), chills, body aches, joint pain, swollen cervical lymph nodes and fatigue. No treatments were taken for the events. The patient had recovered from the events on unknown date.
48 2021-01-04 swollen extremities Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontin... Read more
Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontinued. Proceeded to PCP office the following day due to face, neck and arm stiffness, edema in hands, legs, and face, continued metallic taste, and elevated BP (160/100). PCP prescribed oral steroids, antihistamine, and Epi-Pen.
48 2021-01-05 lymph node swelling, lymph node pain Swelling and pain in right axillary lymph node. Started 1 week after vaccine
48 2021-01-05 peripheral swelling, bursitis, lymph node inflammation, swollen extremities Approximately, on day 6-7, left antecubital swelling and tenderness. Over next few days, gradual wor... Read more
Approximately, on day 6-7, left antecubital swelling and tenderness. Over next few days, gradual worsening pain and edema of the area and inner aspect of left upper extremity. Pain felt into the left axilla, Focal redness over ventral aspect of elbow. First, I did not relate it to vaccine and was not sure of etiology. Day 13: linear red indurated/ palpable ropy area , markedly tender in proximal forearm. Worse swelling and pain. Day 14: red Line extends upward towards axilla Day 15: Saw primary care physician Recommended antibiotics and Aspirin, warm compresses and ordered ultrasound. Findings were consistent with lymphadenitis and lymhpangitis
48 2021-01-05 peripheral swelling c/o headache 5 min after vaccine given initially 4-5/10 then decreased to 3-4/10. vital signs stable... Read more
c/o headache 5 min after vaccine given initially 4-5/10 then decreased to 3-4/10. vital signs stable 138/91 HR105 no rash, no redness, no induration at site. no resp distress. vital signs recheck 134/91 pulse 97 at 1233, advised to go to ER if symptoms worsened, discharged at 1638. Patient called clinic at 1330 on 1/6/21 c/o continued headache, now improving, Temp 99.2, facial flushing, bilateral arm and leg swelling also now improving. patient advised to go to urgent care or ER however patient refused and said she will go to her new primary MD on 1/8/21 and will go to ER if symptoms worsen. Also patient stated had COVID-19 test by occupational health results pending.
48 2021-01-05 swelling face left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at... Read more
left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at emergency room 1330 symptoms increased. airway not obstructed. No tongue swelling reported by MD. Light red rash/flushing on chest. 25mg IV benadryl administered. IV Solumedrol administered, Vital signs stable. Cardiac monitor: regular rate and rhythm. O2 saturations 98% on room air. Symptoms improving at 1345pm. Monitored in emergency room for 1 hour. Discharged in stable condition with instructions to repeat Benadryl 8 hours after first dose if needed Throat fullness ( left side) with mild difficulty swallowing continued. Headache 5pm. Left sided face fullness/tingling: jaw, cheek. Left eye: mild swelling. 25 mg Po Benadryl taken. 01/06/21 0800 AM symptoms Left sided facial fullness/tingling continues: mild. No difficulty breathing. Left eye mild/yet decreased puffiness continues.
48 2021-01-06 anaphylactic reaction anaphylactic reaction; neuropathy in fingers, toes, roof of mouth/lips; This is a spontaneous report... Read more
anaphylactic reaction; neuropathy in fingers, toes, roof of mouth/lips; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL0140) at single dose on left arm on 30Dec2020 at 09:00 for COVID-19 immunization. Medical history included asthma (controlled); hypertension diagnosis 1 year ago; allergies to medications, food and environmental. Concomitant medications in two weeks included antihypertensives - amlodipine and losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Dec2020 at 9:15 AM, the patient experienced anaphylactic reaction within 10 minutes of administration, neuropathy in fingers, toes, roof of mouth/lips. Neuropathy continued to date. The adverse events resulted in emergency room/department or urgent care. The patient received treatment Epinephrine IM (intramuscular) and IV (intravenous) steroids. The outcome of events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of anaphylactic reaction and neuropathy peripheral due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including serum tryptase and nerve conduction studies, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
48 2021-01-06 lymph node pain Very sore arm 1st day. 2nd day sore arm and lymph nodes under left arm where I got injection ,chill... Read more
Very sore arm 1st day. 2nd day sore arm and lymph nodes under left arm where I got injection ,chills ,fever ( on Wed 6th pm) fatigue
48 2021-01-06 swelling face Pt reported right sided facial swelling (no numbness or tingling) after admin of 2nd COVID19 vacc... Read more
Pt reported right sided facial swelling (no numbness or tingling) after admin of 2nd COVID19 vaccine. Pt had been diagnosed with COVID19 on 12/27 between both vaccines. SHe denied any numbness, tingling, weakness, tongue swelling, lip swelling, dysphagia, wheezing or shortness of breath. no eyelid swelling. no rash.
48 2021-01-07 lymph node swelling Patient developed watery eyes later in the afternoon of receiving her COVID. The following day she ... Read more
Patient developed watery eyes later in the afternoon of receiving her COVID. The following day she had flu like symptoms and this morning she has bilateral swollen lymph nodes in the axilla area.
48 2021-01-07 peripheral swelling Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, mala... Read more
Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, malaise, myalgia, dizziness.
48 2021-01-07 swelling face Initial event was soreness at site which resolved on its own within a few days. 2 days after receiv... Read more
Initial event was soreness at site which resolved on its own within a few days. 2 days after receiving vaccine, I began having an allergy reaction to the same brand N95 that I had been utilizing since the beginning of the pandemic. Symptoms are swollen cheeks and welts , sudden itchiness at the site of my mask placement. The reason for this report is a sudden onset of excruciating and debilitating pain throughout my body specifically pain of my right shoulder radiating down my sprightly arm. I have been receiving testing and treatment for ongoing neuropathy due to Longhauler syndrome, however This recent pain is so debilitating, I spend most of my time in bed. I have been experiencing chills then profuse sweating. I also so fatigued, I sleep much of the day. I have been having episodes of tachycardia with chest tightness which has increased since after having the vaccine. I also become short winded on exertion. I?ve been waking up in a panic and sweating.
48 2021-01-08 lymph node pain Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse s... Read more
Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse sweating. Within 30 minutes heart rate increased and a little clearing of throat. A little over an hour nausea started and increased clearing of throat , slight feel of constricture in throat and a slight feeling of heaviness in chest, and jittery and heart rate still feels increased. Nurse at Nursing home watched for 45minutes until I chose to leave. In my vehicle and home is when nausea started. Phone call contacts with nursing home staff continued for an hour. I took 2 benadryl and 2 Tylenol, napped. Felt better. Nausea 3 days. Tired and neck lymph achy.
48 2021-01-08 swelling face, peripheral swelling Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter i... Read more
Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter in her chest shortly after vaccination done 12/22/20 (while being observed). States she informed staff, RNs in clinic state this employee did not report any reactions to clinic staff. Employee returned to work in ICU, states "felt better by end of day". 12/23/20 states swelling to both feet, reports 6+ (?) pitting edema. 12/24/20 states abdomen swollen. Called advice nurse who recommended she report to ED. Employee declined ED and took Benadryl instead. 12/26/20 states face swollen, joint pain, legs felt like they were on fire, could barely walk. 12/28/20 states feels better . Left foot a little swollen
48 2021-01-11 lymph node swelling, lymph node pain Symptoms - ? EE reports she woke up Sunday am not feeling well and reports symptoms of body aches, c... Read more
Symptoms - ? EE reports she woke up Sunday am not feeling well and reports symptoms of body aches, chills, axillary lymph node tenderness and swelling, fever (Tmax 102.2). EE reports she called off of work Monday but later came to work later at approximately 09:00. EE reports Monday resolution of all symptoms except still worsening lymph node tenderness and swelling. EE reports she emailed Woodlands EH RN and advised to contact HR vaccine support line to notify of adverse reaction. EE report she filled out V-safe. Last day of work and shift - ?currently working today Home remedies? - rest and motrin (last dose at 8:30 PM on Sunday 1/10) Any improvement? ? EE reports resolution of all symptoms except lymph node swelling and tenderness Recommendation? EE encouraged to rotate Tylenol and motrin q3h and to contact PCP for appointment.
48 2021-01-11 lymph node swelling L axillary lymph node swelling and pain ( shot was in L deltoid injection site_)
48 2021-01-11 swelling face facial swelling, temporary loss of vision in one eye
48 2021-01-11 swelling January 4. Noticed neck swelling and pulsating neck while brushing teeth. No fever noted. Neck sw... Read more
January 4. Noticed neck swelling and pulsating neck while brushing teeth. No fever noted. Neck swelling noted with bounding pulse in jugular region x 9 days. Seen by physician Jan 5. Neck ultrasound performed Jan 11. Awaiting results.
48 2021-01-12 bursitis L shoulder pain following vaccine. EE seen for medical treatment on 1/8. was dx with subacromial bur... Read more
L shoulder pain following vaccine. EE seen for medical treatment on 1/8. was dx with subacromial bursitis secondary to vaccine placement. ice, rest, medication
48 2021-01-12 lymph node swelling Painful Left supraclavicular lymphadenopathy
48 2021-01-12 lymph node swelling Fever, chills, body aches, headache, injection site pain, swollen lymph nodes left axilla
48 2021-01-12 swollen extremities Increased pain, URE/axilla swelling, intermittent shooting pain in URE starting on 1/12/2021 approx.... Read more
Increased pain, URE/axilla swelling, intermittent shooting pain in URE starting on 1/12/2021 approx. 1430, progressively worsened.
48 2021-01-13 anaphylactic reaction Anaphylactic reaction with EpiPen administration in vaccination clinic, followed by Rapid Response T... Read more
Anaphylactic reaction with EpiPen administration in vaccination clinic, followed by Rapid Response Team initiation and immediate transport to Emergency Room.
48 2021-01-13 lymph node swelling FIVE DAYS OF SISTOMES,HEADACHE,MUSCULAR PAIN, CHILLS GANGIOS INFLAMATION ,SWELLING OF LIPS.
48 2021-01-13 swelling face knot developed behind left ear, swelling and redness in lower part of face; confusion and cognition ... Read more
knot developed behind left ear, swelling and redness in lower part of face; confusion and cognition issues; dizziness
48 2021-01-13 white blood cell count increased Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covi... Read more
Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covid hub had me do a Covid test, negative result, continue high fever, no appetite, chills and body ache, Health Hub contacted me daily with app to review symptoms, Dec 27-29 continued symptoms, unable to eat and little bit of water intake, Dec 29 appointment made with Health Urgent Care, received text from Urgent Care cancelling appointment and instructed to take sips of water and Tylenol that I was having an immune reaction to vaccine. Dec 29 virtual appointment with PCP continued symptoms, Dec 31 repeat of COVID swab along with Flu swab both negative, Jan 2-3 hospital admission for abnormal labs, jaundice, dehydration, Sodium/Potassium and Magnesium boluses given, and work up for infectious process was negative. Discharged to home Jan 3 with low grade fever, dry mouth, dry eyes, nausea, body ache and continued loss of appetite. Jan 4-7 continued worsening jaundice and appetite with low grade fever, GI Clinic consulted at Health Clinic, PCP in daily contact, repeat liver function labs on Jan 8 showed worsening labs. Jan 9-12 afebrile, started Ursodiol, low appetite better energy, continue dry mouth, GI appointment Jan 12 with plan to repeat liver functions on Jan 15, jaundice improved and able to eat liquids. No Tylenol or antipyretic taken since Jan 3 due to liver function tests.
48 2021-01-14 lymph node swelling Within 24 hrs of injection, I had chills and headaches, no fever; these went away after 24 hrs, then... Read more
Within 24 hrs of injection, I had chills and headaches, no fever; these went away after 24 hrs, then my injection site on my L arm was swollen and red the following day after injection, my arm was sore. On the 13th of Jan, I was at work from 7am-7pm and my arm was even more swollen, sore, itchy and reddish, no fever, I was still able to work, but my L axillary area was sore the whole day. I went home and took a shower and noticed that my L armpit was swollen, like the size of a tennis ball! No redness, no fevers but sore and discomforting due to the swelling.
48 2021-01-14 peripheral swelling day 1- no side effects Day 2- low grade temp, very sore arm, red, swollen, chills, felt lethargic, w... Read more
day 1- no side effects Day 2- low grade temp, very sore arm, red, swollen, chills, felt lethargic, woke up in wet clothes from sweat, headache, runny nose Day 3- sore arem, red and swollen, warm to touch, felt lethargic day 3- arm just red and warm to touch. big red circle where shot was given day 4- sitting down and out of nowhere a sharp pain felt in back by neck and shoulders. could not move my neck. arm still a little red but not warm to touch. swelling went down. (went to ER on day 4. blood work and xrays were negative for anything. was given muscle relaxer.) day 5 sore muscles but on muscle relaxer to help day 6 until day 10 - just fatigue and sore muscles/joint pain but tolerable.
48 2021-01-14 peripheral swelling Patient states she noticed a welt on her arm 3 days after receiving the 2nd dose of the vaccine. She... Read more
Patient states she noticed a welt on her arm 3 days after receiving the 2nd dose of the vaccine. She tried applying ice on the most red part on the arm but the swelling continued to grow. Then she started applying heat in addition to applying HPR+ cream that she uses for urticaria. The only thing that the patient stated that helped a little was the ice pack. The patient ended up going to the emergency department on 1/14/2020 for the rash / welt that developed beyond her arm and to the neck and eyelid area which she described as itchy. The patient was prescribed a 4 day prednisone 50mg daily course along with Benadryl as needed and Pepcid 40mg daily which she states have helped alleviate the itchiness but has not completely resolved yet as of today 1/15/2020. Per ED note, patient presented with mild erythema around the injection site and non-specific rash to the neck. Patient has clear speech and no oral swelling and no signs of anaphylaxis. Patient discharged home in stable condition and advised to follow up with primary care doctor in 2-3 days.
48 2021-01-14 swelling face face, with periorbital swelling and wheezing 38 to 45 hours post vaccine, to sore throat start... Read more
face, with periorbital swelling and wheezing 38 to 45 hours post vaccine, to sore throat started 24 hours after vaccine . Severe headache and joint pain started 27 hours after vaccine
48 2021-01-17 lymph node swelling At approximately hour 40 post vaccine my Axillary lymph node became very enlarged, painful and hard.... Read more
At approximately hour 40 post vaccine my Axillary lymph node became very enlarged, painful and hard. It was causing a tingling in my arm, like a pinched nerve and was painful to keep my arm in a relaxed position. The node was visible if I lifted my arm above my head. With a dose of ibuprofen, the swelling reduced but it was still palpable and painful for the next 18 hours. By the 72 hour vaccine mark, all symptoms were gone.
48 2021-01-17 swelling face I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a la... Read more
I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a large room that was busy with my mask, jacket and glasses on, I calmed down but did not feel well. I walked to my car, my fingers were a little tingly, then when I took my mask off the left side of my face was swelling, tingly, red (I have rosacea- but this was different) I did not panic, but I knew something was wrong. I decided to drive to the hospital instead of driving home, the valet said my face was swelling. I went to the ER - was given Pepic and Benadryl via an IV - I was there for observation - as I was waiting for my medication, I began to feel itchy at the base of my neck and on my chest
48 2021-01-17 swelling face nausea, head ache, dizziness, SOB, face swelling a bit
48 2021-01-17 swelling face On Tuesday (1/12/21) night face and neck started itching and burning. Face was starting to swell an... Read more
On Tuesday (1/12/21) night face and neck started itching and burning. Face was starting to swell and neck was red and had small bumps on it. Took some Benadryl and went to bed woke up this morning and eyes were swollen and face was a little worse. No record that patient sought medical attention or visited the ED. Patient reported swelling and itching went resolved the weekend of 1/16/21.
48 2021-01-18 lymph node swelling Patient had 2 adverse reactions with the same administration of vaccine (2nd dose). At the day of t... Read more
Patient had 2 adverse reactions with the same administration of vaccine (2nd dose). At the day of the vaccine, patient started with leg weakness and a sensation of "heaviness" and tremors. Received hydration at ER Room. But 2 days later, developed severe lymphadenopathy at axilla of the same arm (right) where received vaccine.
48 2021-01-18 peripheral swelling ear congestion Bilateral hand swelling, redness BP 132/92 HR 107 P 70 99% RA
48 2021-01-19 anaphylactic reaction Site: Itching at Injection Site-Severe, Systemic: Anaphylaxis-Medium, Systemic: Rash (other than inj... Read more
Site: Itching at Injection Site-Severe, Systemic: Anaphylaxis-Medium, Systemic: Rash (other than injection site)-Medium
48 2021-01-19 anaphylactic reaction Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, onl... Read more
Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, only prior sensitivity to Avocado. During clients 15 minute wait she stepped outside complaining of being hot. A nurse provided water for client, as well as juice. She stated she felt better. Nurse accompanied her back in side, and went over other signs and symptoms of anaphylaxis. Client stated she was not experiencing any of those symptoms and that she felt better. When her wait was complete, she walked to the coat room with other employees, and her throat and ears began to itch, and she was coughing to help itch her throat. At this time the vaccine director was alerted and anaphylactic protocol was initiated. EMS was called- the time was 4:37 pm, pulse was 80, blood pressure was 178/108. 4:39- client refused epi, so 1mL/50Mg, IM Benadryl was given in the right deltoid. Simultaneously, a tourniquet was placed above the vaccine site on the left deltoid. Distal pulses monitored in left arm every 5 minutes. 4:41 itching and coughing increased, client agreed to Epi. 0.3 mg Epi pen given in right thigh. EMS arrive and transported client to hospital for observation.
48 2021-01-19 lymph node swelling injection site pain; headache; body aches; chills; joint pain; T 99.3; L axillary swollen lymph node... Read more
injection site pain; headache; body aches; chills; joint pain; T 99.3; L axillary swollen lymph node; administration date=24Dec2020,dose number=1/administration date=11Jan2021, dose number=2; administration date=24Dec2020,dose number=1/administration date=11Jan2021, dose number=2; This is a spontaneous report from a contactable nurse reported for herself. The 48-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) , via an unspecified route of administration at left arm on 11Jan2021 16:15 at single dose for covid-19 immunisation. Medical history included none, had no allergies to medications, food, or other product. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN). Patient previously received first dose BNT162B2 ( lot number: EK5730) , via an unspecified route of administration at right arm on 24Dec2020 at 08:30Am at single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 04:00AM, 12hrs after 2nd dose injection she experienced injection site pain, headache, body aches, chills, joint pain, T 99.3, L(Left) axillary swollen lymph node; Symptom improvement with Tylenol and Ibuprofen. 48hrs later(14Jan2021)- all symptoms resolved except left axillary swollen lymph node. There is no covid prior vaccination. Patient had covid tested post vaccination, rapid antigen via nasal swab on 12Jan2021 with negative result. Treatment (Tylenol and Ibuprofen) were taken as a result of all events. Outcome of left axillary swollen lymph node was recovering, of injection site pain, headache, body aches, chills, joint pain, T 99.3 was recovered on 14Jan2021. Events were non-serious by reporter.
48 2021-01-20 lymph node swelling, lymph node pain Enlarged supraclavicular lymph node with swelling and pain
48 2021-01-20 peripheral swelling 48 hours post-injection thumb on opposite side of the injection became swollen and stiff. There was ... Read more
48 hours post-injection thumb on opposite side of the injection became swollen and stiff. There was no trauma to the thumb. No other joints are swollen or stiff. The joint is more swollen, stiff and painful 1 week later (1/20/21), leading to a video visit with PCP who recommended alternating heat and ice, and continued use of NSAID as needed.
48 2021-01-21 swollen extremities, lymph node swelling Lymphadenopathy, right axilla - moderate swelling with pain.
48 2021-01-22 lymph node swelling Fever 102.7 , chills, arm with axillary lymph node swelling.
48 2021-01-23 anaphylactic reaction chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking.... Read more
chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking. anaphylaxis EKG monitoring, IVF, IM Epinephrine, IV Benadryl, IV Pepcid, Albuterol dual neb, CXR, Labs sent home after 6 1/2 hours of treatment and monitoring. Sent home with Epi pen
48 2021-01-24 lymph node swelling, peripheral swelling 1/9/21 swollen left cervical and supraclavicular lymph nodes 1/12/21 blunt effusion left knee with s... Read more
1/9/21 swollen left cervical and supraclavicular lymph nodes 1/12/21 blunt effusion left knee with subsequent development of Baker's cyst, swollen bilateral axillary lymph nodes 1/25/21 worsening of left knee pain, swollen left calf
48 2021-01-24 lymph node swelling, swelling, swollen extremities 23 Jan-Saturday-severe Headaches Sunday-24th Jan-Left under arm-swollen lymph nodes 25th Jan -Severe... Read more
23 Jan-Saturday-severe Headaches Sunday-24th Jan-Left under arm-swollen lymph nodes 25th Jan -Severe HA, site of injection-left deltoid-swollen-swollen behind neck-lymph nodes-she said Motrin-HELPS
48 2021-01-24 peripheral swelling Vaccinated on 1/22/2021 around 0945. By 2100 that night, symptoms began to set in. No fever but fel... Read more
Vaccinated on 1/22/2021 around 0945. By 2100 that night, symptoms began to set in. No fever but felt febrile, body aches, joint pain, and "it felt like all my organs were under attack. I felt better Sunday morning', January 24th. After the 1st dose, arm swelled to elbow and had minor body aches but nothing too significan.
48 2021-01-24 sepsis Acute pancreatitis with sepsis; Acute pancreatitis with sepsis; This is a spontaneous report from a ... Read more
Acute pancreatitis with sepsis; Acute pancreatitis with sepsis; This is a spontaneous report from a contactable pharmacist, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 17Dec2020 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fexofenadine (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020, the patient experienced acute pancreatitis with sepsis, which were reported as serious for hospitalization and being life threatening. The patient had gone to the emergency room due to the event and was hospitalized for a total of 6 days. On 29Dec2020 and 31Dec2020, the patient had COVID-19 nasal swabs performed and both results were negative. Therapeutic measures were taken as a result of acute pancreatitis with sepsis and included gall bladder removal. The clinical outcome of acute pancreatitis with sepsis was recovering.; Sender's Comments: Based on the temporal relationship, the association between the events pancreatitis with sepsis with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
48 2021-01-25 lymph node swelling Left arm pain in armpit; swollen lymph nodes; led to whole left arm pain; This is spontaneous report... Read more
Left arm pain in armpit; swollen lymph nodes; led to whole left arm pain; This is spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm single dose for COVID-19 immunization on 10Jan2021, 09:30 AM, at 48-year-old. Medical history and concomitant medication were not reported. No known allergies. The patient did not have COVID prior vaccination. The patient did not have other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm for COVID-19 immunization on 20Dec2020, 05:30 PM, at 48-year-old. On 11Jan2021, 05:00 PM, the patient had left arm pain in armpit with swollen lymph nodes, led to whole left arm pain. No treatment received. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. Information on the lot/batch number has been requested.
48 2021-01-25 swelling face, peripheral swelling Red swollen face, swelling in hands fingers. Face was tight and felt as if it were burning. Claritan... Read more
Red swollen face, swelling in hands fingers. Face was tight and felt as if it were burning. Claritan was provided, issue resolved in about two hours.
48 2021-01-25 swelling neck was mildly swollen/mild superficial neck swelling; bounding pulse (palpitations); bounding puls... Read more
neck was mildly swollen/mild superficial neck swelling; bounding pulse (palpitations); bounding pulse (palpitations); This is a spontaneous report from a contactable consumer on behalf of herself. A 48-year-old female patient received her first BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EH9899, via an unspecified route of administration on 28Dec2020 at SINGLE DOSE at left upper arm for COVID-19 immunisation. There were no relevant medical histories or concomitant medications. The patient had a vaccination on 28Dec2020 and seven days later on 04Jan2021 her neck was mildly swollen and that same day it became more swollen and she had a bounding pulse also reported that had mild superficial neck swelling and a bounding pulse in her neck. The swelling has gone down, but got worse in the evening. The bounding pulse (palpitations) in her neck has improved but got worst at night, still occurred at night. No difficulty breathing and/or swallowing. She went to her physician on 05Jan2021 to find out why occurring. She was called to see if based off this symptom if she should have her second shot of vaccination. Followed up with her MD and had an Ultrasound (US) of her jugular in Jan2021 and all was normal. The outcome of the events was resolving.
48 2021-01-26 lymph node swelling, lymph node pain a bunch of swollen lymph nodes/lymph node was now larger/ a really big bulge like above the collar b... Read more
a bunch of swollen lymph nodes/lymph node was now larger/ a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary; a bunch of swollen lymph nodes/lymph node was now larger/ a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary; feelings of like disconnection; Feelings of like of being drunk; another larger bulge under her right axillary and that one was causing off and on under the armpit, she was getting some shooting pain; Fatigue; This is a spontaneous report from a contactable Nurse. This 48-year-old female Nurse (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via unspecified route at left upper arm on 11Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension. Concomitant drugs included lisinopril for blood pressure/hypertension, omeprazole and vitamin supplements. Historical vaccine included the first dose of BNT162B2 (lot# EK5730) on 21Dec2020 for COVID-19 immunization and having a swollen lymph node along her collar bone on the left side which was on the side where she got the shot and it didn't really change much, it just kind of stayed the same size and it remained there for whole three weeks. Nurse stated then she got the second dose of the vaccine and thought that what she was having were a bunch of swollen lymph nodes, and that lymph node was now larger and she had a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary (12Jan2021) and that one was causing off and on under the armpit, she was getting some shooting pain and her lymph node was larger now as well, the lymph node along her collar bone. Nurse further stated she also had some intermittent fatigue that she expected and also off and on feelings of like disconnection or feelings of like of being drunk. But that's not very bothersome, that's just once in a while since 11Jan2021. But she was concerned about the swelling of lymph nodes. No treatment was received for events. Outcome of events was not recovered. Nurse believed that swollen lymph nodes, fatigue and feeling drunk were due to the Covid 19 Vaccine.
48 2021-01-26 lymph node swelling Supraclavicular lymph node swelled to about pea size after 1st dose; This is a spontaneous report fr... Read more
Supraclavicular lymph node swelled to about pea size after 1st dose; This is a spontaneous report from a contactable Other-HCP. This 48-year-old female Other-HCP reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) at Left arm at single dose for COVID-19 immunization in Dec2020 06:00 AM. Relevant history included Known- allergies: Augmentin. Other medications in two weeks included sertraline 50mg, vitamin D3 5000 IU. The patient was not pregnant. The patient experienced supraclavicular lymph node swelled to about pea size after 1st dose and stayed that size until 2nd dose. The outcome of event was Recovered with lasting effects. No treatment was received. The patient was not diagnosed with covid-prior-vaccination. The patient did not have covid-tested-post-vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021030973 Same patient same product, similar event, different event time gap
48 2021-01-26 lymph node swelling Lymphadenopathy in left axilla
48 2021-01-26 swelling, swelling face, lymph node swelling swelling in shot arm; swelling in left side of neck; Facial swelling; The arm, neck, face swelling s... Read more
swelling in shot arm; swelling in left side of neck; Facial swelling; The arm, neck, face swelling seemed to be lymphatic; shoulder swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 12Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included nasal sinus allergies (otherwise healthy), some shellfish sensitivities and mouth swelling with some spices allergy from an unknown date and unknown if ongoing. Concomitant medication included clarithromycin (CLARITIN). The patient previously took codeine and experienced itching reaction. The patient stated, "The night of the vaccine I awoke at 1am with moderate amount of swelling in shot arm, swelling in left side of neck and facial swelling on 13Jan2021 01:15 AM. No breathing problems so I did not go to hospital. Some swelling went down with Benadryl. On the second night, swelling came back in same places with neck/shoulder swelling being worse." The patient called her doctor who set up an appointment for 15Jan2021. Sweeping is some better on the third day have continued to take Benadryl, Motrin seemed to make it worse (as reported). The patient further stated, "My doctor has advised me not to take the second dose of Pfizer COVID 19 vaccine due to the swelling going beyond just arm swelling. The arm, neck, face swelling seemed to be lymphatic." all on 13Jan2021 01:15 AM. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was given to the patient for the event, over the counter medications - Benadryl and Motrin. The outcome of the events was recovering. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events ware considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect. The patient was not pregnant.
48 2021-01-27 axillary mass Moderate lump to Breast/axilla area
48 2021-01-27 lymph node swelling, peripheral swelling Arm was very sore couldn't move it started taking ibuprofen that night. On Sunday arm started turnin... Read more
Arm was very sore couldn't move it started taking ibuprofen that night. On Sunday arm started turning red a size of a softball was extremely red swollen and hot to the touch, shoulder area and under arm pit was swollen and hurt to touch are move. Was informed by employee health to start taking antihistamines (which I already take) so she told me to increase the amount by taking Benadryl as well and icing it on and off for 30 minutes at a time, The people here at my work checked it regularly and slowly it is improving each day as long as I ice and take extra antihistamines.
48 2021-01-27 lymph node swelling Severe muscle pain across upper back (felt like muscle was being pulled off bone, unable to sit up f... Read more
Severe muscle pain across upper back (felt like muscle was being pulled off bone, unable to sit up for longer than 10-15 minutes at a time without leaning on desk or needing to lay down), general muscle pain (not as severe) throughout the rest of my body. Headache, fatigue (exhausted), brain fog, muscle tightness (unable to take a deep breath due to tightness...not short of breath). Swollen lymph nodes in right armpit, overall feeling exhausted. Treatment: I just slept a lot, took Tylenol. I have a doctors appointment today. Outcome: Slowly getting better. Still have brain fog , fatigue (not exhausted anymore), muscle weakness (not the severe pain anymore).
48 2021-01-27 lymph node swelling Under my left arm was sore after each dose of the Pfizer-BioNTech COVID-19 Vaccine. I suspect swolle... Read more
Under my left arm was sore after each dose of the Pfizer-BioNTech COVID-19 Vaccine. I suspect swollen lymph nodes. The reaction occurred 7days after the first dose and the next day after the 2nd dose. While the armpit started to feel better before the 2nd dose I wouldn't say symptoms resolved before the 2nd shot.
48 2021-01-27 swelling Pt developed redness and swelling to neck, along with lightheadedness several minutes after injectio... Read more
Pt developed redness and swelling to neck, along with lightheadedness several minutes after injection. BP, pulse, oxygen saturation and breath sounds were all within normal limits. She denied any dyspnea or difficulty swallowing. EMS was called promptly and pt was given Benadryl 50mg x1 while EMS was en route. Her symptoms remained stable and she was taken to the hospital by Rescue.
48 2021-01-28 oral herpes I have a cysts/lesion on the outside of my lip (I thought it was a pimple but it was so big and I ne... Read more
I have a cysts/lesion on the outside of my lip (I thought it was a pimple but it was so big and I never felt anything come on like I always do). I also have internal cold sores - one almost right on the other side of the lesion, one on the other side of my lip. I DO NOT KNOW IF THIS IS A SIDE EFFECT or just a coincidence. I don't have herpes or any history of lip lesions. I don't remember biting my inside lip and they are too high for that type of injury anyway.
48 2021-01-28 peripheral swelling FEVER OF 101-103 FOR 24 HOURS.SEVERE ALL OVER BODY PAIN, FEET INFLAMMED UNABLE TO WALK UNTIL PAIN ME... Read more
FEVER OF 101-103 FOR 24 HOURS.SEVERE ALL OVER BODY PAIN, FEET INFLAMMED UNABLE TO WALK UNTIL PAIN MEDICATION (TYLENOL AND IBUPROPHEN) HELPED RELEIVE ENOUGH OF THE PAIN. READ AND SWOLLEN FEET LOWER LEGS. UPPER BACK PAIN LINGERING. TOP OF HEAD PAIN, SCALP PAIN. SEVERITY OF PAIN HAS GONE AWAY, FOOT AND LEG ISSUES HAVE GONE AWAY. UPPER PART OF BODY AND HEAD STILL HURT.
48 2021-01-29 anaphylactic reaction After ten minutes my throat began to feel swollen, a feeling of a lump in my throat. After around 2... Read more
After ten minutes my throat began to feel swollen, a feeling of a lump in my throat. After around 20 minutes I also began to feel more light headed/dizzy. I was moved to be observed by a nurse for another 20 minutes and when symptoms did not subside I was moved to the Emergency Department where they administered Epinephrine at 9:27am, Pepcid, 9:24am, Solu-medrol 9:24-10:50am. Diagnosis: Anaphylaxis. Dr. wanted to prescribe Benadryl IV but I declined as I needed to drive home and the facility was far from home. I was discharged around 1:00pm. A prescription for an Epi Pen was made by Dr. and filled that day at pharmacy. and spoke to my Dr. at another healthcare organization at 4:30pm. Benadryl OTC was then rx'd by my primary care doctor at 4:30pm-50mg every 6 hrs moving to 25 mg every 6 hours the next day. Symptoms of swollen throat continued into the next day and have not yet abated but also have not worsened. Due to continued throat swelling I have taken 50mg of Benadryl the next day as well. Dr. my primary care Dr. scheduled an allergist appt for Feb. 3, 2021 and advised I should not get the second dose of the COVID19 vaccine until I speak with an allergist and have a treatment plan developed.
48 2021-01-31 lymph node swelling Fever chills, headache, nausea , vomiting , a large amount of pain from vaccination. The first one n... Read more
Fever chills, headache, nausea , vomiting , a large amount of pain from vaccination. The first one no pain . The second one really hurt maybe due to the person giving it . I had a fever low grade till noon 1/31/21. The scariest was pain and swelling in my lower armpit on my left arm where vaccinated. I found a study that it can happen but I freaked out . 48 after I experienced the lymphnodes swelling the pain went away but still swollen . I think this should be listed as people with a cancer history will freak out if they think their cancer is back . Lymphoma or breast . I aldd also read that vaccinated women need to alert their radiologists before a mammogram as the swollen lymphnodes could mimic Breast cancer and lymphnodes involvement, which would scare women to death . Physicians should be made aware and the public should be iNformed of the above to reduce panic and unnecessary testing .
48 2021-02-01 lymph node swelling had sx 27 hours after 2nd vaccine of red raised rash on back, chest and upper neck, itchy, swollen ... Read more
had sx 27 hours after 2nd vaccine of red raised rash on back, chest and upper neck, itchy, swollen lymph nodes on neck and both arm pits on 2/2, very fatigue
48 2021-02-01 peripheral swelling, swollen extremities SWELLING IN BILATERAL LOWER EXTREMETIES, FACIAL EDEMA AND HANDS, UTI, NEW ONSET ANEMIA, LEGS FELT L... Read more
SWELLING IN BILATERAL LOWER EXTREMETIES, FACIAL EDEMA AND HANDS, UTI, NEW ONSET ANEMIA, LEGS FELT LIKE THEY WERE GOING TO POP AND SOME SOB
48 2021-02-01 peripheral swelling I began noticing 2 days after receiving the second vaccine joint stiffness and aches. At the end of ... Read more
I began noticing 2 days after receiving the second vaccine joint stiffness and aches. At the end of my 9 hour shift I was very stiff in all of my lower joints from the hips down as well as uncomfortable from the achiness. I walked slowly and stiffly as I was leaving work. I felt extremely tired that night and decided to work a shorter shift the next day - 8 hours rather than 9 hours. I took ibuprofen prior to my second shift. I was still achy and stiff but it was a little better witht he ibuprofen. The next day at home on the weekend I was again achy and stiff and took ibuprofen. I woke up on 1/25 with swollen hands that were painful and stiff. I have since had daily swelling of both hands and achiness in wrists non
48 2021-02-03 swelling face Rash chest and face. Face and throat swelling. Difficulty swallowing. Taken to ER and given steroid... Read more
Rash chest and face. Face and throat swelling. Difficulty swallowing. Taken to ER and given steroid, benadryl, and pepcid. Systemic affects x3 days. Medications given for a total of 5 days.
48 2021-02-04 lymph node swelling, lymph node pain body aches; felt very tired; lymph node in her left armpit swelled and was painful; lymph node in he... Read more
body aches; felt very tired; lymph node in her left armpit swelled and was painful; lymph node in her left armpit swelled and was painful; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249), via an unspecified route of administration on 15Jan2021 at 12:45 in the left arm at a single dose for COVID-19 immunization. The patient's medical history included COVID 19. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on an unspecified date for COVID-19 immunization and tetracycline and which she had an allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at 20:00, the patient started having body aches , felt very tired and the lymph node in her left armpit swelled and was painful. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on an unspecified date. The events were considered non-serious.
48 2021-02-04 lymph node swelling bad headache that felt like migraine; bad headache that felt like migraine; thought it might be a si... Read more
bad headache that felt like migraine; bad headache that felt like migraine; thought it might be a sinus headache; pain on the right side of the back of her neck that radiated behind her right eye; pain on the right side of the back of her neck that radiated behind her right eye; dizziness; sweating; swollen lymph nodes in her throat; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 15Jan2021 at 07:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 15Jan2021, the patient experienced dizziness, sweating, and swollen lymph nodes in her throat. On 18Jan2021, the patient started to get a really bad headache that felt like migraine and thought it might be a sinus headache. On the same day, the patient also had pain on the right side of the back of her neck that radiated behind her right eye. The patient would like to know if she could take anything for her headache. The outcome of the event bad headache that felt like migraine was not recovered while the other events was unknown. Information about lot/batch number has been requested.
48 2021-02-07 lymph node swelling, swollen extremities Got vaccine on 2/5/2021 started with diarrhea that evening and the next day, Saturday became fatigue... Read more
Got vaccine on 2/5/2021 started with diarrhea that evening and the next day, Saturday became fatigue continues intermittently, Sunday 2/7/2021 noticed swelling to the left axilla with enlarged lymph node continues with it today 2/8/2021
48 2021-02-07 lymph node swelling, swelling marked swelling; swollen lymph nodes under left arm, armpit, neck and collarbone area all on left si... Read more
marked swelling; swollen lymph nodes under left arm, armpit, neck and collarbone area all on left side; Very Painful; This is a spontaneous report from a contactable healthcare professional, the patient. A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL3302), via an unspecified route of administration on 19Jan2021 at 12:00 (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications that were received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL1284), via an unspecified route of administration on 29Dec2020 at 12:00 (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. On 20Jan2021 at 06:00, the patient experienced marked swelling and swollen lymph nodes under left arm, armpit, neck and collarbone area all on left side, very painful. The patient stated she did not have redness. The clinical outcomes of the swelling, swollen lymph nodes under left arm, armpit, neck and collarbone area all on left side, and pain were not recovered. It was also reported that since the vaccination, the patient has been tested for COVID-19, the patient had PCR nasal swab on 18Jan2021, which was negative and rapid test nasal swab on 21Jan2021 which was negative.
48 2021-02-07 lymph node swelling Injection site rash; Swollen lymph nodes; Headache; Teeth hurt on left side; Hot/cold flashes; Hot/c... Read more
Injection site rash; Swollen lymph nodes; Headache; Teeth hurt on left side; Hot/cold flashes; Hot/cold flashes; Nausea; Vomiting; Symptoms of perimenopause; This is a spontaneous report from a contactable consumer. A 48-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number=EL9262), via an unspecified route of administration at Left arm on 19Jan2021 15:00 at single dose for covid-19 immunization. The patient medical history included known allergies: penicillin. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0142), on 01Jan2021 12:00 PM at Left arm at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site rash, swollen lymph nodes, headache, teeth hurt on left side, hot/cold flashes, nausea/vomiting, symptoms of perimenopause on 20Jan2021 at time of 12:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
48 2021-02-07 swollen extremities Almost 24 hours after my first vaccine, I woke up from a nap and my left armpit was swollen and sore... Read more
Almost 24 hours after my first vaccine, I woke up from a nap and my left armpit was swollen and sore. Within a few hours, I had throbbing pain into the left side of my breast. I assumed it was from my lymph nodes reacting, but I didn't know if this is normal or expected. Also, I hadn't heard anything about swelling, tenderness in the armpit or breast discomfort. I took tylenol and ibuprofen and the breast throbbing went away before I went to sleep that night. The swelling and tenderness in my left armpit lasted for 4 days.
48 2021-02-08 lymph node swelling Fever, severe body aches, chills, headache, fatigue, swollen lymph nodes
48 2021-02-09 pancreatitis Developed mid to right sided upper abdominal pain that radiated into back on 12/31/20, admitted to h... Read more
Developed mid to right sided upper abdominal pain that radiated into back on 12/31/20, admitted to hospital on 1/2/21 for pancreatitis along with 2 other admissions (1/16/21 & 1/30/21) for same abdominal pain radiating into back.
48 2021-02-09 peripheral swelling, lymph node swelling swollen armpit lymph nodes and upper right arm; swollen armpit lymph nodes and upper right arm; arm ... Read more
swollen armpit lymph nodes and upper right arm; swollen armpit lymph nodes and upper right arm; arm tingling to fingers; very uncomfortable; Right armpit discomfort; This is a spontaneous report from a contactable healthcare professional (the patient). A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140), intramuscular in the right arm on 20Jan2021 at 10:00 (at the age of 48-years-old) as a single dose for Covid-19 immunization. Medical history included central nervous system disorder (CIS) from an unknown date. The patient did not have any allergies to medications, food or other products. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140) on 30Dec2020 in the right arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jan2021 at 18:00, the patient experienced right armpit discomfort. On 22Jan2021 the patient experienced swollen armpit lymph nodes and upper right arm leaving the right arm tingling to fingers and very uncomfortable. Therapeutic measures were not given for the events. The clinical outcome of the events axillary pain, lymphadenopathy, peripheral swelling, paresthesia and discomfort was not recovered. It was reported that since the vaccination (dose 1), the patient had been tested for COVID-19 via a PCR nasal swab on 19Jan2021 with a negative result.
48 2021-02-09 swelling After vaccination, patient reports swelling to the size of a golf ball over the course of 3 days. P... Read more
After vaccination, patient reports swelling to the size of a golf ball over the course of 3 days. Patient went to urgent care. They determined that the vaccine had inadvertently been administered sub-q, not IM, leading to granuloma formation. Urgent care outlined site of reaction and instructed patient to take antiinflammatories until swelling subsides; if swelling increases beyond the drawn border then go to ER. Swelling decreased over the next several days, only small amount of redness remains on 2/8.
48 2021-02-09 swelling swollen, painful left axilla area; swollen, painful left axilla area, gotten progressively worse; di... Read more
swollen, painful left axilla area; swollen, painful left axilla area, gotten progressively worse; difficult to raise arm due pain; difficult to raise arm due pain, very tender to touch, felt like burning; This is a spontaneous report from a contactable Other HCP(patient). A 48-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3248), via an unspecified route of administration at Arm Left on 16Jan2021 07:00 at the 48 years old at single dose for COVID-19 immunization. The medical history included HTN(Hypertension), HLD(Hyperlipidemia), Migraines, Depression, Herniated Discs, Arthritis. There were concomitant medications but unspecified. The patient previously took Codeine and experienced allergy. On 22Jan2021 6 days after vaccine, the patient experienced swollen, painful left axilla area, gotten progressively worse, difficult to raise arm due to pain, very tender to touch, felt like burning had continued for 3 days. The patient taken Ibuprofen, Tylenol, and Iced area as treatment for all the events. There was no other vaccine in four weeks. There was no covid prior vaccination. There was no covid tested post vaccination. The outcome of the event was not recovered.
48 2021-02-10 lymph node swelling, peripheral swelling The left calf is swollen 3/4 inch; Left knee effusion/ she got the Bakers cyst test, the fluid leake... Read more
The left calf is swollen 3/4 inch; Left knee effusion/ she got the Bakers cyst test, the fluid leaked into the area that formed into this area; swollen cervical and supraclavicular lymph nodes on the left side/ swollen axillary lymph nodes on both sides; This is a spontaneous report from a contactable healthcare professional (Physician Assistant) reporting for self. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EL0142, Dose 1, intramuscularly on 07Jan2021 07:15 (at the age of 48 years old) as a single dose in left arm for COVID-19 immunization. Medical history included ongoing undifferentiated spondyloarthropathy diagnosed more than 10 years ago. Concomitant medication included golimumab (SIMPONI), 0.5mg subcutaneous injection once a month for undifferentiated spondyloarthropathy. There were no prior vaccinations in the past 4 weeks. There were no adverse events with prior vaccinations. Two days after the vaccine on 09Jan2021 she experienced swollen cervical and supraclavicular lymph nodes on the left side. On 12Jan2021 by 09:00 she developed left knee effusion and swollen axillary lymph nodes on both sides. It was worse "now" (as of Jan252021); she states she got the Bakers cyst test, the fluid leaked into the area that formed into this area. On an unspecified date, the left calf was swollen 3/4 inch. The events did not require a visit to the Emergency Room. The events did require a visit to her rheumatologist on Friday, 22Jan2021. There reporter declined having had treatment for the events. The outcome of the left knee effusion was not recovered; left knee effusion was reported as worsened. The outcome of swollen on axillary lymph nodes on both sides, swollen cervical and supraclavicular lymph nodes on the left side was recovering. The outcome of left calf was swollen 3/4 inch was unknown. Her rheumatologist was asking if he can drain it or send fluid for any studies prior to any treatment, and for any advice or if any special markers need to be drawn in case Pfizer would like more information on this.
48 2021-02-10 lymph node swelling headache; Headache 'in the back of head, the right side of her face behind her eyes', started gettin... Read more
headache; Headache 'in the back of head, the right side of her face behind her eyes', started getting a migraine.; could be sinuses; Dizziness; Sweating; lymph nodes swollen; she tends to get hot flashes, she is currently going through menopause; This is a spontaneous report from a contactable consumer, the patient. A 48 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EL3248 ), intramuscular in the left arm on 15Jan2021 at 06:34 as a single dose, for COVID-19 immunization. The vaccination was administered at a Hospital Facility. Patient contact her doctor who told her, she absolutely needed the COVID-19 vaccine. Medical history included ovarian cancer 2014 (stage 3B and 3C), lymphoedema 2015, (lymphedema after aggressive chemo/ told she would always have lymphedema), and menopause from an unknown date and ongoing (tends to get hot flashes). There were no concomitant medications. On 15Jan2021 (around noon), the patient experienced Lymph nodes swollen/her lymph nodes in her throat were swelling up, dizziness, and sweating. Patient explains she tends to get hot flashes, she is currently going through menopause. However, she ran to the store and she was really sweating heavily and felt dizziness and just ended up going home. She felt it was better to be at home if she was having a reaction. By Saturday, 16Jan2021, she woke up and felt fine. The swelling of her lymph nodes in her throat went away. The dizziness and sweating went away. On 19Jan2021 (Tuesday Evening) the patient experienced Headache 'in the back of head, the right side of her face behind her eyes', started getting a migraine. Also states it could be sinuses. She didn't know if this could be related to the COVID-19 vaccine and a reaction to it or her sinuses. On Jan2021 patient experienced Hot flashes. No other vaccines were given within 4 weeks. The clinical outcome of Dizziness, Sweating was recovered on 16Jan2021, the outcome of Headache/migraine was not recovered, and the outcome of lymph nodes swollen, hot flashes and sinuses were unknown.
48 2021-02-10 lymph node swelling 1/4 Vaccination. 12 hours later; arm pain, lump on arm with redness. Within 24 hours, lump was large... Read more
1/4 Vaccination. 12 hours later; arm pain, lump on arm with redness. Within 24 hours, lump was larger. Lymph nodes swollen. Lump was about size of a softball, all lymph nodes swollen. Symptoms about a week. Sought attention from NP. She stated to ice and Ibuprofen.
48 2021-02-10 swelling face allergic reaction; severe lip/facial swelling on left side of face and top lip/swelling two days lat... Read more
allergic reaction; severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip; severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, first dose on 30Dec2020 at 09:00 (Lot number: EL0140) in the right arm and second dose on 20Jan2021 (Lot number: EL3246) in the left arm, both at the age of 48-years-old at a single dose for COVID-19 immunization. Medical history included low vitamin D, hypothyroid, Von Willebrand's, and idiopathic anaphylaxis (years ago, outgrew). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications within two weeks of vaccination. The patient previously received botulinum toxin type A (BOTOX) in the forehead years ago. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip and allergic reaction on 31Dec2020. The events were reported as non-serious. The clinical course was reported as: The patient woke up with severe lip/facial swelling on left side of face and top lip. The patient went to doctor and they thought it was allergic reaction, but not sure if it was the vaccine. After the patient received the second dose, she had swelling two days later on right bottom side of face and lip. The patient had no lip/facial filler. The patient did not receive any treatment for the events. The clinical outcome of severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip and allergic reaction was recovered in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
48 2021-02-11 lymph node swelling Pain and Swollen supraclavicular Lymph Nodes on left side
48 2021-02-11 lymph node swelling Chills, fever, muscle spasms, convulsing, splitting headache, bone and joint aches, muscle aches, ra... Read more
Chills, fever, muscle spasms, convulsing, splitting headache, bone and joint aches, muscle aches, rash on neck, chest and back, itchy back, swollen lymph nodes (under jaw) really large lymph node in groin area appeared 10 days post vaccination, trouble breathing, exhausted, light headed, nausea, white chalky furry tongue., diarrhea.
48 2021-02-11 swelling face, swelling facial and neck swelling 4 days after vaccine administration , seen Private physician who treated it... Read more
facial and neck swelling 4 days after vaccine administration , seen Private physician who treated it with Benadryl.
48 2021-02-11 swelling After the first vaccine I experienced some pain on the left side of my neck into my jaw. The day af... Read more
After the first vaccine I experienced some pain on the left side of my neck into my jaw. The day after the second vaccine I noticed a lump above my left clavicle. That evening the lump was larger and visible. The next day the lump became even larger and at one point the swelling in my neck seemed like it might impede my airway. After using a warm compress the swelling came down a little. I called the on-call doctor who recommended a follow up in the office. It wasn't until 2 days later that it wasn't visible anymore but could still be palpated. I had an appointment with my physician on Tuesday just to make sure it was a swollen lymph node. She advised it was soft and moveable and most likely a swollen lymph node but to keep an eye on it and if the swelling didn't go down in two weeks to get further testing.
48 2021-02-12 lymph node swelling swollen glands/lymph nodes on the left side of the neck(BEHIND EAR) and head. painful
48 2021-02-13 peripheral swelling Swelling and redness of right foot toes 1-3 at bedtime. Issue resolved on its own overnight.
48 2021-02-15 lymph node swelling 1. Shortness of breath - tightness in chest; moderate x 1 day; intermittent; 2. Headache moderate - ... Read more
1. Shortness of breath - tightness in chest; moderate x 1 day; intermittent; 2. Headache moderate - severe x 2 days 3. Muscle/joint pain entire body and injection site - moderate x 2 days; mild continuous; 4. Fever, chills x 1.5 day 5. Fatigue - mild ongoing; 6. Swollen lymph node in neck on the left side (same side received injection).
48 2021-02-16 lymph node swelling 2-4-21 2000 Nausea/upset stomach 2-5-21 0100 Fever/chills, HA, injection site pain, joint pain, musc... Read more
2-4-21 2000 Nausea/upset stomach 2-5-21 0100 Fever/chills, HA, injection site pain, joint pain, muscle pain, tiredness, nausea/upset stomach, loss of sense of taste and smell 2-6-21 HA, injection site pain/swelling, joint pain, muscle pain, tiredness, nausea/upset stomach, lymphadenopathy, nausea/upset stomach, loss of sense of taste and smell 2-7 -21 HA, injection site pain/swelling, joint pain, muscle pain, tiredness, nausea/upset stomach, lymphadenopathy, nausea/upset stomach, loss of sense of taste and smell 2-8-21 HA, injection site pain/swelling, muscle pain, tiredness, nausea/upset stomach, lymphadenopathy, loss of sense of taste and smell 2-9-21 HA, injection site pain/swelling, muscle pain, tiredness, nausea/upset stomach, lymphadenopathy, diarrhea 2-10-21 Fatigue, lymphadenopathy, vertigo 2-11-21 Fatigue, lymphadenopathy, vertigo 2-12-21 Fatigue, lymphadenopathy, vertigo 2-13-21 Fatigue, lymphadenopathy, vertigo 2-14-21 Lymphadenopathy, vertigo 2-15-21 Lymphadenopathy, vertigo 2-16-21 Lymphadenopathy, vertigo 2-17-21 Lymphadenopathy, vertigo
48 2021-02-17 lymph node swelling on the day of the vaccine my right was arm and the area where I received the vaccine was red, the ne... Read more
on the day of the vaccine my right was arm and the area where I received the vaccine was red, the next day the pain decreased and was almost gone by the end of the day. But on 02/17/21 at work I discovered a small bump on my right side bonecollar, without knowing what it was as I never felt it before, I decided to go to the doctor, she said it is a lymph node swelling and is about 1.5cm and could possibly be a result of the COVID-19 vaccine and that she believes it'll disappear within the next few days and might have the same results after the second vaccine.
48 2021-02-17 swelling face By 8 am, I recognized I realized I felt different - headache and foggy and tired. By 12 pm my headac... Read more
By 8 am, I recognized I realized I felt different - headache and foggy and tired. By 12 pm my headache became really severe - even when walking or chewing. My face was really hurting me; very tender by left eye. I felt so tired. I had to go home from work at 2:30. Felt very cold and I put on really warm clothes and got under three 3 blankets and I slept for three hours. I felt better by that evening, I slept normally that night. Face was very swollen under my eyes - two days after vaccine. (I have filler under my eyes - it's been a year since I had that put in.) Benadryl every six hours. It took 12 hours for pain to go away and for it to decrease. But it did help. Everything resolved.
48 2021-02-18 anaphylactic reaction Anaphylaxis
48 2021-02-20 lymph node pain, lymph node swelling 2 days after the vaccine my left arm pit lymph nodes grew VERY large and painful about the size of a... Read more
2 days after the vaccine my left arm pit lymph nodes grew VERY large and painful about the size of a tennis ball sliced in half. I also experience numerous episodes of fevers and sweating. The next day (3 days post vaccine), I developed a large red rash reaction at the injection site on my left arm. It was the circumference of a tennis ball and was hard, hot to the touch, and very painful. There was also a burning sensation. Today is the 3rd day post vaccine so I don?t have information about how long this will last. Feel free to contact me for a follow up. I just wanted to get this info out there to those that need it.
48 2021-02-20 lymph node swelling Swelling of left side lymph node under my arm
48 2021-02-21 lymph node pain, lymph node swelling arm very painful; swollen and tender left axillary and left supraclavicular nodes; swollen and tende... Read more
arm very painful; swollen and tender left axillary and left supraclavicular nodes; swollen and tender left axillary and left supraclavicular nodes; chills; red x 5 days; This is a spontaneous report from a contactable healthcare professional (patient). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249; dose 2) via an unspecified route of administration on 20Jan2021 at 1:30 PM (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included hypertension and mild asthma. The patient was not pregnant at the time of vaccination. It was unknown if the patient had COVID-19 prior to vaccination. The patient took concomitant medications which were unspecified. The patient did not received any other vaccines within four weeks prior to the vaccination. The patient previously took penicillin on unknown dates for an unknown indication and experienced allergy. The patient received dose 1 of BNT162B2 (lot number: EL0104) on 30Dec2020 at 11:30 AM in the left arm as a single dose for COVID-19 immunization. On an unspecified date after the second vaccination, the patient had arm very painful, red for 5 days, and swollen and tender left axillary and left supraclavicular nodes. On 21Jan2021, 24 hours after the vaccine, the patient experienced chills lasting three to four hours. The patient did not have adverse effects at all after the first vaccine. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The outcomes of arm very painful and red, swollen and tender left axillary and left supraclavicular nodes, and chills were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
48 2021-02-21 lymph node swelling swollen of the lymph node, pain on left arm that radiates to upper back
48 2021-02-22 lymph node swelling Significant Left under arm swelling (area swollen approximately size of baseball in half) Significa... Read more
Significant Left under arm swelling (area swollen approximately size of baseball in half) Significant pain under left arm Redness along outside of left breast Pain in Left breast Pain Left shoulder to Left elbow Nausea and hot flashes - Mild
48 2021-02-22 lymph node swelling Received vaccine 1/15/21. 3 days later, developed axillary LAD ipsilateral to vaccine administration... Read more
Received vaccine 1/15/21. 3 days later, developed axillary LAD ipsilateral to vaccine administration. The next day, developed upper back pain. Symptoms have persisted for >1 month and not responding to OTC pain medication.
48 2021-02-23 lymph node pain Redness, warmth, itchiness at injection site, 2 inch diameter redness. Facial flushing bilateral. Sh... Read more
Redness, warmth, itchiness at injection site, 2 inch diameter redness. Facial flushing bilateral. Shoulder lymph and neck lymph on left side.
48 2021-02-23 lymph node swelling Swollen lymphnodes, coughing, headache, fatigue, sinus drainage
48 2021-02-24 swelling face Patient received her first COVID vaccination today at 8:30 pm. Within 15 min of injection, she bega... Read more
Patient received her first COVID vaccination today at 8:30 pm. Within 15 min of injection, she began to look distressed and reported sensations of tingling in her elbows and behind her knees. No SOB, facial swelling, or heart palpitations. It was felt she may be nervous and she was given water and monitored closely. Vitals taken with O2 100%, HR 58, BP 134/89 Pt received Benedryl 25 mg when she began to note mild erythematous blotching on neck 10 min later vitals stable with bp 138/82 and pulse 62 Pt was given a second 25 mg dose to take if any symptoms worsened on way home- she was driving therefore I did not want to give her another dose at the time. She understands to call for emergency care if any SOB, facial swelling, or any distress Pt confirmed at 10 pm that she made it safely home with some improvement in her symptoms. I will follow up with her in the morning as well and will complete a VAERS report. I have educated her that at this time CDC would recommend not receiving the second vaccination, given potential allergic reaction within first 4 hours. We will review this again tomorrow I communicated with patient morning of 2/25/21- she states still mild tingling of arms but no new or worsening symptoms. She feels this is more consistent with anxiety and hesitant to not receive her second dose. I suggested she discuss with her primary care provider before her next visit and if she were to proceed with her second vaccination, I would suggest someone being with her to drive and she take 50 mg of benedryl 1 hr prior to vaccine. She was appreciative.
48 2021-02-25 swelling face Pt received first dose of Pfizer covid19 vaccine. After about 40 minutes, pt endorsed of having swel... Read more
Pt received first dose of Pfizer covid19 vaccine. After about 40 minutes, pt endorsed of having swelling in the upper left of lip, swelling in the nose , itchy feeling in the left eyelid and swelling in the right eye lid. Per pt, the swelling is mild and moderately bothersome. We observed the pt for another 60 minutes and pt reported that her symptoms have subsided. However, she still experiences mild nose swelling but she stated that it was much less than before. No medication/treatment was administered. Pt went home and was instructed to contact emergency services if reactions become severe. Pt stated that she may take Benadryl at home.
48 2021-02-25 swelling Fever; cough; diarrhea; swelling; burning; This is a spontaneous report from a contactable consumer.... Read more
Fever; cough; diarrhea; swelling; burning; This is a spontaneous report from a contactable consumer. A 48-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK4176) via an unspecified route of administration in right arm on 22Jan2021 12:00 at single dose for COVID-19 immunisation. The patient received the vaccine in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. The patient received unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fever, cough, diarrhea, swelling, burning on 22Jan2021 16:00. The patient didn't receive any treatment for events. The outcome of events was recovering.
48 2021-02-27 lymph node swelling Lymphadenopathy started approx 22 hrs after first dose. Tender left axilla, radiation to left breast... Read more
Lymphadenopathy started approx 22 hrs after first dose. Tender left axilla, radiation to left breast and left scapula with numbness noted 5th digit left hand approx 48 hrs after injection. Tenderness, pain increasing daily. Currently only second day post injection.
48 2021-02-28 lymph node swelling, swollen extremities, lymph node pain Severe pain and swelling of lymph nodes under the right armpit and right side of breast. Pain level... Read more
Severe pain and swelling of lymph nodes under the right armpit and right side of breast. Pain level was a 9 on a scale of 10. Feels like a golf ball is there but not to the touch. I barely slept the first night. I thought I was imagining the swelling but took pictures to compare left and right arm. Swelling is definitely noticeable. I didn't have Tylenol in the house so I used a wet wash cloth underneath my right arm pit to ease the pain. Helped a little bit but not much. The next night I used a refrigerated Gatorade bottle underneath my arm which worked much better. 3rd night I finally was able to get Tylenol and that seemed to help more so but I am still swollen and painful but now more tolerable.
48 2021-03-04 peripheral swelling Arm Pain - onset 6h post injection Body aches - 24h post injection Arm pit pain & swelling - 34h pos... Read more
Arm Pain - onset 6h post injection Body aches - 24h post injection Arm pit pain & swelling - 34h post injection Headache -34h post injection Injection site swelling/lump - 38h post injection Lightheaded - 44h post injection
48 2021-03-05 lymph node swelling 9pm: nauseous, chills, fever, soreness, headache, extreme fatigue 11pm: Took 15ml NyQuil 8AM: took ... Read more
9pm: nauseous, chills, fever, soreness, headache, extreme fatigue 11pm: Took 15ml NyQuil 8AM: took 2 800mg tylonal 9am 3/5/2021: chills subsided All symptoms lasted until 11pm on 3/5/2021 3/6/2021: lymph node on left side swollen and sore, mild headache and mild fatigue and fogginess
48 2021-03-06 axillary mass Dizziness, nausea, fatigue, fever, chills, muscle soreness, pain in left hand, swollen and painful a... Read more
Dizziness, nausea, fatigue, fever, chills, muscle soreness, pain in left hand, swollen and painful armpit.
48 2021-03-07 swelling face beginning 2 days after shot, woke up w/ puffy eyes, became to become more swollen including bridge o... Read more
beginning 2 days after shot, woke up w/ puffy eyes, became to become more swollen including bridge of nose, cheeks.
48 2021-03-07 swelling I started having symptoms about an hour after receiving the shot. Bad pain, chills, swelling, heada... Read more
I started having symptoms about an hour after receiving the shot. Bad pain, chills, swelling, headache, tiredness and feeling unwell, etc. About Thursday, I noticed bumps starting to appear on me. IT was just a few and I was trying to deal with all of the other symptoms. By Friday, they started to appear more and more and are progressing as the days go on. I'm covered in bumps/rash.
48 2021-03-09 swelling Headache, fatigue, joint pain, muscle pain, angioedema (face, neck, arms), dry eyes. Severe pain in ... Read more
Headache, fatigue, joint pain, muscle pain, angioedema (face, neck, arms), dry eyes. Severe pain in neck near implanted surgical metal. Period started 1 week early. Resolved I?m 48 hours with rest, heat packs, Tylenol and Benadryl.
48 2021-03-10 anaphylactic shock anaphylactic shock; BP 209/109 within 15 minutes of the shot/elevated BP; major headache; This is a ... Read more
anaphylactic shock; BP 209/109 within 15 minutes of the shot/elevated BP; major headache; This is a spontaneous report from a contactable other HCP. This other HCP reported for herself that a 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) at the age of 48-years, via an unspecified route of administration in left arm on 28Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included nerve damage; multiple surgeries from a wreck. Patient was not pregnant, was not pregnant at time of vaccination, there was no other vaccine in four weeks. No COVID-19 prior vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA); loratadine (CLARITIN); colecalciferol (VITAMIN D); ascorbic acid (VITAMIN C); probiotics nos. The patient previously took rofecoxib (VIOXX), miconazole nitrate (MONISTAT), gabapentin, flu shot, all experienced allergies. At 10:45 AM on 28Jan2021, the patient experienced shortness of breath (SOB), BP 209/109 within 15 minutes of the shot, clammy, major headache. Received diphenhydramine hydrochloride (BENADRYL) on site and transferred by ambulance to hospital where she received Epishot, dexamethasone and ketorolac tromethamine (TORADOL). Diagnosed with anaphylactic shock. Went home with elevated BP and major headache. Daughter called an ambulance that night because the headaches were so bad. Ambulance driver stated they couldn't do anything for patient at the hospital unless she exhibited stroke like symptoms. BP stayed elevated for 2 days and headaches continued. Started to feel better 5 days later. Followed up with her PCP and patient was put on steroids for 5 days to taper down. The adverse events resulted in doctor or other HCP office/clinic visit, emergency room/department or urgent care. Patient received BENADRYL, epinephrine, dexamethasone, TORADOL as treatment for AEs. Lab data included: patient was tested negative for COVID-19 virus test (nasal swab) on 23Feb2021. Outcome of the events was recovered in Feb2021.; Sender's Comments: Based on the close temporal relationship, the association between the events anaphylactic shock, BP increased and headache with BNT162b2 use can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
48 2021-03-10 swelling Angioedema of the right side of the patient's face from the inferior orbit down, sparing the upper l... Read more
Angioedema of the right side of the patient's face from the inferior orbit down, sparing the upper lip, and involving the lower lip. Accompanied by numbness for a few hours which then subsided, with lingering tenderness upon palpation.
48 2021-03-11 swelling, swelling face, peripheral swelling Patient reported swelling of face and tingling of lips within 4 hours of second COVID-19 vaccine. Im... Read more
Patient reported swelling of face and tingling of lips within 4 hours of second COVID-19 vaccine. Immediately afterwards, patient was dizzy, flushed feeling, tingling of my lips, and swelling of the right side of my face. These symptoms were not enough to seek medical attention but were there. After that, I had swelling down my arm and into my right hand, up my neck and face, up and down the right side of my back. I have been extremely tired and weak feeling. Some improvement but I am still really sore and the RSD is starting to act up. I have called into work, been eating well, drinking a lot or water, moving as much as I can, and using Advil and Tylenol for pain management. Called into work for three days.
48 2021-03-11 swelling Terrible pain and swelling under my left arm (arm pit area) with pain shooting into my left breast. ... Read more
Terrible pain and swelling under my left arm (arm pit area) with pain shooting into my left breast. Pain at the injection site that traveled through my arm to the joints in my wrist.
48 2021-03-13 lymph node swelling Day of vaccine: extreme muscle weakness and tenderness at injection site 24 hours later: chills, fev... Read more
Day of vaccine: extreme muscle weakness and tenderness at injection site 24 hours later: chills, fever of 100 degrees, body aches, extreme fatigue 48 hours later: low grade fever, normal menstruation turned into extremely painful menstruation, swollen lymph nodes, sweating like breaking a fever
48 2021-03-14 lymph node swelling Fever, arm soreness at injection site, chills, muscle aches, and extremely swollen lymph nodes at le... Read more
Fever, arm soreness at injection site, chills, muscle aches, and extremely swollen lymph nodes at left clavicle
48 2021-03-17 lymph node swelling Within 30 minutes of receiving the first dose of the COVID vaccine, I ban to feel tingling on the le... Read more
Within 30 minutes of receiving the first dose of the COVID vaccine, I ban to feel tingling on the left side of my face. Within another 30 minutes, I had multiple blisters in the same spot. Within another 2 hours, the lymph nodes on the left side of my neck were swollen.
48 2021-03-17 swelling loss of appetite; spontaneous bleeding under skin by right eye; severe pain under arm in armpit with... Read more
loss of appetite; spontaneous bleeding under skin by right eye; severe pain under arm in armpit with swelling; severe pain under arm in armpit with swelling; hot feeling on skin; extreme fatigue; had some itchy skin and redness an hour after shot, especially on both arms; had some itchy skin and redness an hour after shot, especially on both arms; Extremely nausea/Often nauseous; insomnia; mild diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 48-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9809; expiration date not provided), via an unspecified route of administration (anatomical location: arm right) on 09Feb2021 18:00 at SINGLE DOSE for COVID-19 immunisation. Medical history included asthma and known allergies to sulfa drug both from unknown dates and unknown if ongoing. The patient has no COVID prior vaccination. Patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262; expiration date not provided) on 19Dec2020 02:30 pm (vaccination location: left arm) and experienced dizziness, extreme itchy skin, headache, and fatigue reported as 'After 1st shot had dizziness and extreme itchy skin 1 hour after shot for approx 2 hours before it ended, then headache and fatigue for 1-2 days. However, after 48 hours all effects from the 1st shot were gone'. The patient experienced spontaneous bleeding under skin by right eye on 14Feb2021. Patient's clinical course is as follows: After 2nd shot, patient had some itchy skin and redness an hour after shot, especially on both arms that lasted a couple hours (started at 7PM and stopped at 9PM). Patient also had extreme fatigue everyday since 11Feb2021, as well as insomnia especially during the first 48 hours. Also had total loss of appetite the past 8 days (17Feb2021), extremely nauseous and mild diarrhea everyday since immediately after 2nd shot until now (8 days later) with no improvement. Often nauseous until close to the point of vomiting. 2 days after 2nd shot started having severe pain under arm in armpit area with swelling and hot feeling on skin. Developed some spontaneous bleeding under skin by right eye about 5 days (14Feb2021) after shot which has now gone away. Fatigue and health is poor with no improvement; most effects seem to be getting worse instead of improving each day. Patient was not COVID tested post vaccination. It was reported that no treatment was provided for the events. Outcome of the event 'had some itchy skin and redness an hour after shot, especially on both arms' was recovered on 09Feb2021; outcome of the event 'spontaneous bleeding under skin by right eye' was recovered; outcome of the remaining events was not recovered.
48 2021-03-19 lymph node pain Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain and swelling Tiredness Muscle pain Chills J... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain and swelling Tiredness Muscle pain Chills Joint pain Nausea Feeling unwell Tender lymph nodes areas Felt feverish, but didn't take temperature
48 2021-03-20 swelling face Continued extreme fatigue, fever, hypertension, bradycardia, severe facial redness and swelling. I a... Read more
Continued extreme fatigue, fever, hypertension, bradycardia, severe facial redness and swelling. I am unable to give a detailed report due to this website expiring in 20 minutes. I will be more than happy to submit a complete timeline if needed.
48 2021-03-21 lymph node swelling 3/18: Upon receiving the injection, nerve tingles began in my left arm, wrist and hand. My jaw and n... Read more
3/18: Upon receiving the injection, nerve tingles began in my left arm, wrist and hand. My jaw and neck became very sore and two small bumps appeared on the back of my neck. The bumps became very sore and my lymph nodes began to swell. All symptoms were on the left side of my body, which is the side I received the injection. 3/19: The two bumps multiplied and I had them behind my ear, in my hairline, on the back and front of my neck, trailing to my shoulder and a patch on my back. The bumps were painful and hot. I vomited 4 times that day, ran a 100 temp for a short period of time, had chills, body aches, very swollen lymph node, mild headache, and a very stiff, sore neck. All of this occurred on the left side of my body. 3/20: The bumps continued to increase in size, pain and number. The swollen glands, sore and stiff neck persisted. I was very tired and felt nausea at times. 3/21: I woke with an extremely sore and stiff neck, sore throat and new patches of bumps. I sought medical treatment and was diagnosed with Shingles. I was 100% healthy prior to the shot. I've never had Shingles before. I am now on medication to treat the outbreak.
48 2021-03-21 peripheral swelling Raised tattoo on the same arm as the vaccine occurred about four hours later. Paper cut the next d... Read more
Raised tattoo on the same arm as the vaccine occurred about four hours later. Paper cut the next day in the am, blood was really thin, watery. Again, paper cut about 42 hours after vaccine, thin blood.
48 2021-03-22 lymph node pain, lymph node swelling The Day after the injection I had full body muscle aches, reddness at injection site. The 2nd Day... Read more
The Day after the injection I had full body muscle aches, reddness at injection site. The 2nd Day after the injection, my muscle aches are better but now my Lymph Node under my arm is very swollen and painful
48 2021-03-22 swelling I received my first dose on 3/3/21 and the adverse reaction occurred from 3/10/21 through 3/19/21. ... Read more
I received my first dose on 3/3/21 and the adverse reaction occurred from 3/10/21 through 3/19/21. My side effects included: headache, fatigue, congestion, dizziness, nausea, diarrhea, chills, myalgia(lots of muscle pain), joint pain and swelling, overall weakness throughout body.
48 2021-03-23 lymph node swelling Unusual Thirst Tiredness Chills Low fever 100.3 Achy all over Sweated all night Swollen armpit lym... Read more
Unusual Thirst Tiredness Chills Low fever 100.3 Achy all over Sweated all night Swollen armpit lymph node Headache
48 2021-03-23 lymph node swelling Swollen lymph glands; Headache; Arm Pain; Fever; First dose on 02Feb2021, second dose on 19Feb2021; ... Read more
Swollen lymph glands; Headache; Arm Pain; Fever; First dose on 02Feb2021, second dose on 19Feb2021; First dose on 02Feb2021, second dose on 19Feb2021; This is a spontaneous report from a contactable healthcare professional reported for herself. This 48-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number El9262) on 19Feb2021 at 08:45 AM single dose at left arm for COVID-19 immunisation. Medical history included known allergies: Penicillin, sulfa and Pre diabetic. Historical vaccine was 1st dose of BNT162B2 (lot number El3247) for COVID-19 immunisation on 02Feb2021 at 08:00 AM at left arm. Concomitant drugs included semaglutide (OZEMPIC), pravastatin sodium (PRAVASTINE), metformin and losartan potassium (LOSARTIN). On 19Feb2021 at 06:00 PM, the patient experienced headache, arm pain, fever and worst part was the swollen lymph glands. The patient had visible swollen under arm into breast and down side of her arm, almost looks like a half a baseball sticking out of her arm. The patient saw doctor on 22Feb2021 and received treatment. The outcome of the events was resolving.
48 2021-03-23 lymph node swelling The morning of the 11th, I woke up quite nauseous and felt sick for a couple of days. On the 22nd I... Read more
The morning of the 11th, I woke up quite nauseous and felt sick for a couple of days. On the 22nd I woke up with very swollen lymph nodes above my left collarbone and in my left armpit as well as a dull headache. I also had a dry, hacking cough. Tuesday, the 23rd, the swelling was quite uncomfortable and prompted me to go to the doctor -- he did a chest x-ray and bloodwork, I'm going in for an ultrasound on my lymph nodes on Thursday, 24 March. The swelling in the lymph nodes has gone down a bit, to the extent that I can now lift my left arm, however today (Wednesday, 23 March) I woke up with a fever (102), extreme nausea, diarrhea, the headache is gone and the cough has subsided, but I cannot eat -- I'm drinking water and taking Tylenol for the fever. My pulse ox has been fluctuation between 90 - 94 all day; I am extremely exhausted and waiting for the fever to break.
48 2021-03-23 lymph node swelling armpits hurting and painful, also down sides; I guess this would be swollen lymph nodes
48 2021-03-23 swollen extremities, lymph node swelling Myalgia, Fever, Rash, lymphadenopathy Narrative: Received 1st dose at 0900 on 3/11/21. Noted incr... Read more
Myalgia, Fever, Rash, lymphadenopathy Narrative: Received 1st dose at 0900 on 3/11/21. Noted increased arm pain that evening and fever that night (up to 100F). Developed swelling in armpit and neck and groin lymph node enlargement on opposite side of injection site. Lymph swelling above clavicle persisted through 3/16/21, though improving. Noted fine papular rash as well. Pt has had COVID infection 11/2020 Other Relevant History:
48 2021-03-24 anaphylactic reaction anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and... Read more
anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and ears; swelling of throat and ears; sudden drop in blood pressure; elevated blood pressure and heart rate; elevated blood pressure and heart rate; inability to breathe all within less than 30 minutes of injection during; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation at a clinic. Medical history included asthma, allergies, and previous history of anaphylaxis to oral sulfa (Sulfa- anaphylaxis). Concomitant medications in two weeks included diphenhydramine hydrochloride (BENADRYL); clarithromycin (CLARTIN); levosalbutamol hydrochloride (XOPENEX); and fluticasone propionate (FLOVENT). There was no other vaccine in four weeks. On 17Mar2021 10:15, the patient experienced pounding of heart, tightness of chest, itching, coughing, hives, swelling of throat and ears, elevated blood pressure and heart rate, sudden drop in blood pressure, and inability to breathe all within less than 30 minutes of injection during observation. Epipen was administered on site and care team called 911. Ambulance arrived, assessed and informed her that she was experiencing anaphylaxis and took her to ER. ER gave her steroids and prescription for epipen and steroids. The next day itching, swollen throat, ears, pounding of heart and tightness of chest came back and she self injected epipen. Went to her doctor and was prescribed more epi pens, singular, Pepcid AC, and refilled her inhalers. She is to her seen again tomorrow by doctor. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and were assessed by reporter as Life threatening illness (immediate risk of death from the event). Treatment for the events include Epipen, steroids, Pepcid AC, singular, inhalers. The outcome of the events was not recovered. The patient was not pregnant at the time of event onset or at the time of vaccination. Patient had no COVID prior vaccination and was not tested for COVID post vaccination.
48 2021-03-24 swelling severe body aches, fever (101.4), moderate-severe headache, ringing in ears that pulses, dizziness/o... Read more
severe body aches, fever (101.4), moderate-severe headache, ringing in ears that pulses, dizziness/off balance, started ~12 hours after injection
48 2021-03-24 lymph node swelling, lymph node pain Soreness at injection site, not much worse than flu shot. Lymph node in under arm area swollen and v... Read more
Soreness at injection site, not much worse than flu shot. Lymph node in under arm area swollen and very sore. Soreness goes down in to elbow.
48 2021-03-24 lymph node swelling Swollen lymph node over collar bone
48 2021-03-25 lymph node swelling Rash around the neck area that spread to chest and back of the neck later in the day. Very itchy and... Read more
Rash around the neck area that spread to chest and back of the neck later in the day. Very itchy and have a burning sensation. The lymph node in the left neck area where the rash is, feels swollen.
48 2021-03-25 peripheral swelling I have a headache, fever, chills, exhausted. Now I have covid arm. My arm is itchy, swollen, pain, a... Read more
I have a headache, fever, chills, exhausted. Now I have covid arm. My arm is itchy, swollen, pain, and have slight rash.
48 2021-03-25 swelling face Itching and swelling on face with uncontrollable coughing
48 2021-03-25 swelling face 40 minutes after receiving the shot my face felt like it was swelling. It felt like my left side of... Read more
40 minutes after receiving the shot my face felt like it was swelling. It felt like my left side of my face swelled first and then 3 minutes later if felt like it generalized to the entire face. (I received the shot on my left side) I also felt some faint tingling in my mouth. Looking in the mirror, I couldn't tell if it was swollen but my sensation of my skin was swollen & tight. After about 10 minutes it felt like it was easing off. A hour later my face felt a little tingly like a Novocain shot had almost worn off. After 3 hours, I felt normal. Then day 2 & 3: a sore arm. Then day 4: muscle aches, fatigue & headache.
48 2021-03-28 peripheral swelling 48 hours post-injection the DIP joint of my left thumb became swollen, and stiff. Swelling increased... Read more
48 hours post-injection the DIP joint of my left thumb became swollen, and stiff. Swelling increased and I lost the ability to bend the thumb at all (could not hold a writing instrument). Pain was minimal, it was uncomfortable due to the stiffness & swellling. I used NSAID, had a telemedicine visit with my PCP on 1/20/21 and she advised to add ice and heat. There was slow improvement starting early February, and today 3/29/21 the swelling and stiffness are about 95% resolved. I have mostly normal range of motion with some stiffness.
48 2021-03-30 lymph node swelling Left armpit and shoulder near the collar bone hurt. Both are tender to touch. The armpit is swoll... Read more
Left armpit and shoulder near the collar bone hurt. Both are tender to touch. The armpit is swollen , looks like an egg shape and hurts from the shoulder to the breaat. Very uncomfortable. Headache, tired, body aches - this is ok.
48 2021-03-30 lymph node swelling Swollen lymph nodes on left arm side of injection.
48 2021-03-31 anaphylactic reaction Patient had an anaphylactic reaction and had to use her Epipen
48 2021-03-31 swelling face, peripheral swelling started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; started swelling in fa... Read more
started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; having arrhythmias and blood pressure issues; having arrhythmias and blood pressure issues; have continued to have. Cardiac issues; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), on 28Dec2020 06:30 PM into right arm at single dose for COVID-19 immunization in Hospital. Medical history included Migraines, high blood pressure that was controlled. Patient was not Pregnant at the time of vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. Concomitant medication (medications the patient received within 2 weeks of vaccination) included hydrochlorothiazide and furosemide (LASIX [FUROSEMIDE]). patient took injection and started swelling in face, hands, eyes. Then started having arrythmias and blood pressure issues. She has continued to have. Cardiac issues as well as blood pressure problems. ill was hospitalized. Duration of hospitalization was 2 days. blood pressure and arrythmias. Patient was currently seeing cardiologist on April 14th to see what can be done. events start date and time was 28Dec2020 06:45 PM. It was unknown if the adverse event result in doctor or other healthcare professional office/clinic visit or Emergency room/department or urgent care. "Location of injection information is available for all vaccines received on the same date". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Lab test included Nasal Swab on 23Jan2021 with negative result. Treatment for the events included medication, in process of seeing a Cardiologist. Outcome of the events was not recovered. Serious criteria is hospitalized and life threatening. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of swelling in face, hands, eyes, arrhythmias, cardiac issue and blood pressure issues cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
48 2021-04-01 lymph node swelling 1st vaccine: pain to immediate area that lasted approx 4 days; headache. 2nd vaccine: severe headach... Read more
1st vaccine: pain to immediate area that lasted approx 4 days; headache. 2nd vaccine: severe headache within a couple of hours, chills all night (about 14 hours after vaccination); pain to area (not as bad as 1st time); golf size protrusion next to armpit, swelling under arm pit, pain to armpit area and sensitivity; tired first 2 days and then exhausted day 5 and 6; rash next to armpit of other arm.
48 2021-04-01 lymph node swelling Follow up: Patient stated she was experiencing sharp pain and numbness in left arm after the vaccine... Read more
Follow up: Patient stated she was experiencing sharp pain and numbness in left arm after the vaccine. Patient took vaccine on Monday 3/30/21 and on Tuesday morning right when she woke up pain increased. Thursday 4/1/21 patient is now experiencing swollen glands under left arm (armpit). Patient took ibuprofen 800mg on Wed 3/31/21 around 9pm, also stated that she experienced a slight headache during the day that subsided after taking excedrin. Recommended for her to take tylenol to help with the arm pain. Patient is also waiting for an appt to see her PCP.
48 2021-04-01 lymph node swelling The morning after the second dose, I woke up with 104 F temperature, chills, massive headache and pa... Read more
The morning after the second dose, I woke up with 104 F temperature, chills, massive headache and pain at the injection site. Took Tylenol every 4 hours all day long - fever, chills and headache did not stop. Had to spend all day in bed, could not eat, had to get someone to take care of my children - literally could not stay awake or function. Next day I woke up feverish and with a mild headache, Tylenol worked and I was able to function although I did not feel completely well. At night the fever came back and also pain in the back of the neck. Fever was not as bad as the day before. Today, Woke up with headache, tylenol worked and I am functional. No fever. The pain at site injection is reseeding; it was sore and lymph nodes of arm pit are still swollen but it does not bother me. The other symptoms were scary.
48 2021-04-01 lymph node swelling I am post menopausal and approximately 5 weeks after having my second covid vaccination, I had vagin... Read more
I am post menopausal and approximately 5 weeks after having my second covid vaccination, I had vaginal bleeding that lasted about a week. I had had no spotting or breakthrough bleeding since my last peroid in September 2019. I had no other unusal side effects. I experienced the expected fatigue, sore arm and axillary lymph node swelling (12 days post vaccination).
48 2021-04-02 lymph node pain, lymph node swelling A swollen lymph node under collar bone on 3/27/21, 2 days after having the 2nd shot on 3/25/21. Now ... Read more
A swollen lymph node under collar bone on 3/27/21, 2 days after having the 2nd shot on 3/25/21. Now (4/3/21) it's been a week, the enlarged lymph node is still there and painful.
48 2021-04-02 lymph node swelling By midnight I was experiencing minor arm soreness like I did with first dose. By early next morning ... Read more
By midnight I was experiencing minor arm soreness like I did with first dose. By early next morning shot location was red, swollen, raised somewhat, hot to the touch, and had spread up my arm to armpit/lymphnodes, very painful. Felt a sensation as though the allergic reaction was spreading across my chest - but no visible signs of that. Im almost 3 days out and still have swelling from injection site underarm. Separate from this, I had a constant headache that started a couple of hours after shot and is finally gone today. I had mild fever the first two days but that seems to have subsided. Was nauseous the first day. Woke up with terrible stomachache this morning followed by diarrhea. All over body aches and pains - were at their worst the first two days, today still there but less so.
48 2021-04-03 lymph node swelling, lymph node pain Joint pain. Swollen lymph nodes. Pain in lymph nodes under right arm. I had some lymph nodes removed... Read more
Joint pain. Swollen lymph nodes. Pain in lymph nodes under right arm. I had some lymph nodes removed from under my right arm in 2010 as treatment for breast cancer. The remaining lymph nodes were extremely sore after the second Pfizer Covid-19 vaccine. I have not had trouble with these lymph nodes since some were removed. It hurt so much I couldn?t sleep. This lasted for about a week. The doctor prescribed pain medication, but I chose not to take it. Just took Tylenol instead.
48 2021-04-03 lymph node swelling Rash near injection site, swollen lymph node on right side of jaw line, gums not healing from dental... Read more
Rash near injection site, swollen lymph node on right side of jaw line, gums not healing from dental work done one week ago (now bleeding, wasn?t before the shot). Symptoms are still ongoing.
48 2021-04-05 lymph node swelling, swelling, swelling face nausea, headaches, muscle stiffness, joint pain, swollen lymph nodes, swelling of face, neck and thr... Read more
nausea, headaches, muscle stiffness, joint pain, swollen lymph nodes, swelling of face, neck and throat, dizziness, fatigue took benadryl 2 tablets every 4-6 hours for 7 days since 3/23/21 and now still taking benadryl occasionally (when needed )started 4/02/21 for swelling of face, neck and throat. Swollen lymph nodes are still present but no other symptoms.
48 2021-04-05 lymph node swelling Swollen lymph nodes in the armpit, chest, and neck area.
48 2021-04-05 swelling face about an hour after getting the first vaccine, I started to get hives on the opposite arm. Followed ... Read more
about an hour after getting the first vaccine, I started to get hives on the opposite arm. Followed by a itchy sensation inside my nose and sinus areas of face swelling. I took 50mg Benadryl per pharmacy direction. Reported allergy reaction to my physicians office. At about hour three of the first dose of Benadryl, the symptoms returned. I waited for the four hours between to take 50mg more. The second dose did not change the symptoms but they proceeded to get worse to a sinus headache and back neck/upper shoulder pain. My blood pressure was slightly elevated and I was light headed. I then went to my physicians office urgent care hours. It was confirmed that I was having an allergy reaction to the vaccine and a stronger allergy medication was written. I took Hydroxyzine mg. I did not take a second dose because symptoms were gone in the morning when I woke.
48 2021-04-06 lymph node swelling Pain at injection site; swelling under arm in lymph node area and left side of left breast; tenderne... Read more
Pain at injection site; swelling under arm in lymph node area and left side of left breast; tenderness under arm, achiness, pain when sneezing/coughing or taking deep breaths in under arm/side breast area.
48 2021-04-06 oral herpes I have a lip cyst/lesion; two cold sores inside my upper lip - one almost directly behind the outer ... Read more
I have a lip cyst/lesion; two cold sores inside my upper lip - one almost directly behind the outer lesion, one on the other side of my mouth; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 at 11:15 (Batch/Lot number and Expiry date: unknown) as single dose for COVID-19 immunisation. Medical history included allergies, asthma, dysthymia, fibromyalgia. History of known allergies include penicillin and amoxicillin. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA); lisinopril; atorvastatin (LIPITOR [ATORVASTATIN]) and atorvastatin taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 29Jan2021 at 14:15, the patient experienced I have a lip cyst/lesion and two cold sores inside my upper lip - one almost directly behind the outer lesion, one on the other side of my mouth. The patient don't know if this was a side effect or just a coincidence. He don't have a history of cold sores and herpes. Therapeutic measures were not received as a result of events. The outcome of the events were not recovered. Information on lot/batch has been requested.
48 2021-04-06 swelling face Received vaccine at 3PM; at 11PM started to have fever and mild arm soreness, by midnight had migrai... Read more
Received vaccine at 3PM; at 11PM started to have fever and mild arm soreness, by midnight had migraine. In the morning at 6AM, had full arm pain at injection site (muscle tight and sore) and fever and migraine continued. At 8 AM, fever was gone, migraine mild, but became puffy (inflamed) in my face and gut. At 1PM my tooth #23 was very sore (just had a filling replaced on that tooth four weeks ago) and entire jaw on right side as very sore.
48 2021-04-07 swelling Jaw and gum teeth pain, swelling on right side with rash. Felt like open nerves on teeth. It hurt ... Read more
Jaw and gum teeth pain, swelling on right side with rash. Felt like open nerves on teeth. It hurt to move jaws.
48 2021-04-08 lymph node swelling In addition to injection site soreness, I started experiencing significant malaise 20 hours after th... Read more
In addition to injection site soreness, I started experiencing significant malaise 20 hours after the shot, at 22 hours after the shot temperature was 100.8 F with shaking chills and body aches, at 24 hours after the shot temperature was 102.4 F with shaking chills and body aches. Treated fever with Tylenol. Temperature was reduced to 101.3 and stayed around there the rest of the day with occasional chills as Tylenol wore off. Lymph node in left arm pit became swollen by 36 hours after the shot but fever, body aches dissipated by 48 hours after the shot. After this there were no further fever or aches and felt substantially better except for a little weakness. By 72 hours after the shot only minor muscle soreness at the injection site and lesser swelling of the lymph node in the left arm pit with no other symptoms.
48 2021-04-08 lymph node swelling Swollen lymph node in left armpit after left arm injection
48 2021-04-08 peripheral swelling swelling, redness, and warmth in shoulder of right arm starting about 7-8pm on 04/08, patient went t... Read more
swelling, redness, and warmth in shoulder of right arm starting about 7-8pm on 04/08, patient went to emergency room on 04/09 where they did an ultrasound and diagnosed her with a superficial blood clot. they told her to take aspirin every day for one month and then return to doctor for a re-evaluation.
48 2021-04-09 c-reactive protein increased Immune Response to the Vaccine. Toe was infected the following day for a week and a half. To return... Read more
Immune Response to the Vaccine. Toe was infected the following day for a week and a half. To return to normal right after 10 days. The left Shoulder hurt and spread throughout the body. Then she experiences Fibromyalgia for 5 days after the Vaccine was administered (21-26MAR21).
48 2021-04-09 swelling face Soreness at injection site, fatigue, swelling of face, nausea, vomiting, diarrhea
48 2021-04-09 swelling face Patient vaccinated at 9:29 a.m. and at 9:40 patient reported feeling facial numbness and arm numbnes... Read more
Patient vaccinated at 9:29 a.m. and at 9:40 patient reported feeling facial numbness and arm numbness and swelling in left side and was seen by medical team Patients vitals were stable but the numbness and swelling sensation begun radiating to the right side of face and tongue Patient transferred via ambulance to hospital
48 2021-04-10 peripheral swelling Horrible headache Body aches Diarrhea Left arm was swollen in injection spot and my armpit swell up... Read more
Horrible headache Body aches Diarrhea Left arm was swollen in injection spot and my armpit swell up too. I could not lift my arm. Symptoms lasted for about 24 hours and then I was fine, except for my arm and armpit. They were still swollen, but I could lift my arm again.. My arm pit did go down a bit, but was swollen for about three days.
48 2021-04-11 lymph node swelling I had extreme dizziness to the point that I could not safely stand up. It has been three weeks since... Read more
I had extreme dizziness to the point that I could not safely stand up. It has been three weeks since my first shot and I still have three swollen glands on my left front collarbone. I went to my doctor, and he confirmed these symptoms were from taking the shot.
48 2021-04-11 swelling face Patient stated after she waited 30 minutes her face swelled along with her eyes. She went to the phy... Read more
Patient stated after she waited 30 minutes her face swelled along with her eyes. She went to the physician and was given benadryl and prednisone tablets. Advised patient she should not receive the 2nd dose of Pfizer in the series and if she is requiring a 2nd dose she should investigate receiving Janssen.
48 2021-04-12 lymph node swelling Axillary node swelling under vaccinated arm. It has been one month and I still have swelling and pa... Read more
Axillary node swelling under vaccinated arm. It has been one month and I still have swelling and pain under my arm, on the side of my left breast and in my chest. I have radiating pain up my shoulder where I was vaccinated and into my neck and jaw.
48 2021-04-12 lymph node swelling Fever~100.5 for 24 hours Nausea ~ 72 hours Discolored stool~ 24 hours (green) Significant body aches... Read more
Fever~100.5 for 24 hours Nausea ~ 72 hours Discolored stool~ 24 hours (green) Significant body aches ~24 hours Enlarged left lymph node under left arm with radiating pain~3 days/72 hours
48 2021-04-12 lymph node swelling Swelling in the armpit day 2 post vaccine Day 4: swollen lymph gland left neck. mild tenderness. 1x... Read more
Swelling in the armpit day 2 post vaccine Day 4: swollen lymph gland left neck. mild tenderness. 1x1 cm
48 2021-04-12 lymph node swelling swollen lymph node on left side (shot arm)
48 2021-04-12 peripheral swelling, swelling face Patient stated that her entire face and right hand swelled within 48 hours of vaccination.
48 2021-04-13 lymph node swelling Headache still present since first dose swollen lymph nodes on neck lasted a week after second dose... Read more
Headache still present since first dose swollen lymph nodes on neck lasted a week after second dose, tiredness , legs feel very heavy since second dose.
48 2021-04-13 lymph node swelling Significant baseball sized swelling in lymph node under right armpit. (Vaccinated arm).
48 2021-04-13 lymph node swelling swollen lymph nodes
48 2021-04-14 lymph node swelling Swollen axillary lymph nodes, soreness in lymph node area. Appeared approximately 12 hours post dos... Read more
Swollen axillary lymph nodes, soreness in lymph node area. Appeared approximately 12 hours post dosing and lasting for approximately 48 hours
48 2021-04-14 peripheral swelling Within 5 minutes my lips, tip of tongue and front area of the roof of my mouth were numb. At 15 minu... Read more
Within 5 minutes my lips, tip of tongue and front area of the roof of my mouth were numb. At 15 minutes still occurring and when I got up to leave the facility I had tightened in my chest, not a pain, but like a charley horse. That tightness lasted about 15 seconds. About 25 minutes after shot I noticed my hands were very swollen. Went home, rested and within two hours hands were normal and tongue and roof of mouth were back to normal. Lips stopped tingling but within a couple of days I noticed that around my mouth and my cheeks were numb. This is still happening and it comes and goes. I went to the doctor 4/13. I do have the start of a sinus infection so taking a Z PAC now. The numbness seems less but it still comes and goes. I have no pain just numbness and stiffness. I told the doctor the best I can describe it is it feels like what Botox looks like (I have never had Botox or fillers).
48 2021-04-14 swelling face, lymph node swelling No initial symptoms. Arm did not hurt. Felt fine initially. A week later, my left eye started to wat... Read more
No initial symptoms. Arm did not hurt. Felt fine initially. A week later, my left eye started to water profusely and itch as if I'd gotten something in it. Within the hour, lymph nod in front of left ear swelled up to the size of a bean. The next morning, additional nods swelled up under the ear by the jawline. The eye was no longer watering, but was and continues to experience sharp pain like pins stuck in it, very painful. Some blurring of vision. It is only in one eye still. Eye is not red. Eye is not watering. It shows no signs of visible conjunctivitis, but very irritated. The following day the left side of my face is swollen along with swollen glands. Additionally, a rash ahs developed along my hairline, on the upper bridge of my nose, and on forehead. The rash on my nose presents like blisters, almost like poison ivy rash. I was not exposed to poison ivy. I do not have acne, so the outbreak on my forehead is unusual. The rash has gotten progressively worse and spread every day since the onset of these symptoms four days ago. I still have no fever. No armpit swelling. Never experienced this before. There was no clear cause of this nor any known infection. Suspect it could be immune response to 1st covid-19 shot. I was very healthy when I took the first shot. Was advised to take a Covid-19 test as the eye hurting is apparently a rare symptom of the virus. Took test yesterday. Awaiting results. But I have no respiratory symptoms. No fever. Do have some mild diarreah since receiving the vax. Feel fine physically other than these very painful facial symptoms.
48 2021-04-14 swelling face Swelling of the mouth, tongue, throat, eyes and face; chest pains; shortness of breath; body pain; h... Read more
Swelling of the mouth, tongue, throat, eyes and face; chest pains; shortness of breath; body pain; headaches; sore throat; coughing;
48 2021-04-15 anaphylactic shock Started to have body aches, head aches and neck pain from next day morning and keep on progressing t... Read more
Started to have body aches, head aches and neck pain from next day morning and keep on progressing the symptoms even after 4 weeks. So tested for Covid on 2/23/21 and was positive. Also tested positive on 11/2/2020 and recovered in 3 weeks. My allergies increased in frequencies and intensity during last 12 weeks and had a severe anaphylactic shock 3 weeks ago which required calling 911 and ER treatment for stabilization. Till today, I have body aches, neck pain, insomnia and head aches and I am doing everything in my knowledge to improve my health. Multiple doctors and specialist appointments, are still continuing for treatment .
48 2021-04-17 swelling I have pain in the armpit area that started on 3/30 in the evening; visional swelling on in the left... Read more
I have pain in the armpit area that started on 3/30 in the evening; visional swelling on in the left armpit area above the breast; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 29Mar2021 09:30 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure/ allergies. Concomitant medication(s) included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ) taken for an unspecified indication, start and stop date were not reported. The patient also received Desloratin within 2 weeks of vaccination. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 09:30 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. No covid tested post vaccination. Since 30Mar2021 17.30 (05:30 PM) evening, the patient had pain in the armpit area. The patient took Tylenol before going to bed. This morning (30Mar2021) there was visional swelling on in the left armpit area above the breast. Outcome of the event was not recovered. No follow up attempts are needed. No further information is expected.
48 2021-04-18 lymph node swelling, lymph node pain Shot received at approx. 10:45 am on 4/17/2021. Started feeling very tired in afternoon, by 6pm on s... Read more
Shot received at approx. 10:45 am on 4/17/2021. Started feeling very tired in afternoon, by 6pm on same date, completely exhausted, achy and headache, sore arm, started having chills on and off 4/18/20 - woke up at approx. 4am crying in excruciating pain. I literally hurt from my hair to my toe nails and everything in between. More than regular muscle aches, could barely function. At some point during the day, I developed a fever. Several times checked thru the day, maintained around 100. Complete exhaustion 4/19/20 - woke up approx. 6am. The excruciating pain had moved to extremely sore muscle, still exhausted, no longer have fever. Notice swollen lymph nodes on left side. I have a welt about the size of a baseball located next to my armpit towards my left breast. VERY swollen and painful. Injection site is still sore and very hot. Fatigue is still keeping me from working. I had to call out sick to work today.
48 2021-04-18 lymph node swelling Starting on 4/18/2021... started to feel soreness/discomfort in my left armpit. By 4/19/2021 MORNING... Read more
Starting on 4/18/2021... started to feel soreness/discomfort in my left armpit. By 4/19/2021 MORNING... it was swollen, too (it currently feels like an apricot/peach is in my armpit)
48 2021-04-18 peripheral swelling My right arm became swollen within 5 minutes of the shot. It started in my finger tips and went up m... Read more
My right arm became swollen within 5 minutes of the shot. It started in my finger tips and went up my forearm and elbow. I experienced tingling in my fingers and a sharp pain in my elbow. My breathing remained normal. I received Benadryl at the testing site. I was advised to continue to take it every 4 hours to alleviate the swelling. It took three two pill doses of Benadryl and icing my arm for the swelling to go down. There is lingering pain in my elbow and wrist.
48 2021-04-19 lymph node pain, lymph node swelling INJECTION SITE PAIN (FOUR DAYS OF INTERMITTEN SITE PAIN) SWOLLEN AND PAINFUL ARMPIT LYMPH NODES (STI... Read more
INJECTION SITE PAIN (FOUR DAYS OF INTERMITTEN SITE PAIN) SWOLLEN AND PAINFUL ARMPIT LYMPH NODES (STILL OCCURING AFTER 5 DAYS)
48 2021-04-19 lymph node swelling "Pfizer-BioNTech COVID-19 Vaccine EUA". observed swelling in the armpit of the left arm. read info... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA". observed swelling in the armpit of the left arm. read information and researched online; determine it was swollen lymph nodes. Area is not painful or sore, it is tender. Currently observing area to determine if area of swelling is changing.
48 2021-04-19 lymph node swelling Lymph Node swelling,
48 2021-04-19 peripheral swelling On Monday, 4/12/21, I was given the 2nd dose of the vaccine. There were no immediate symptoms other... Read more
On Monday, 4/12/21, I was given the 2nd dose of the vaccine. There were no immediate symptoms other than a sore arm (from injection site) later that day. Tuesday morning, my left arm was swollen and I experience joint pain in my fingers and wrist. The following afternoon, I began to feel extremely tired and had vertigo. I laid down and slept the entire evening; still feeling the joint pain. The following Wednesday morning, I woke up to a swollen arm with a knot at the injection site, blisters, body rashes, and whelps under my breast and whelps on my shoulder, legs, and feet. I was even more exhausted. I took Benadryl for the rash and Advil for the pain. Thursday, I continued to develop rashes that would come and go on the left side of my body and upper chest. Friday, still experiencing the inflammation and pain, I visited my doctor who told me to continue taking the Benadryl and OTC pain meds. For good measure, we ordered a d-dimer test. Over the weekend, in addition to the other symptoms, I began to have a lot or ringing in my ears, a backache (throbbing sensation), and my hands began to painfully swell with blisters. I could only taste the salt or sugar in foods and was extremely tired. Monday morning, I received a call from my doctor advising me that the d-dimer test came back extremely high (1.23) and needed to have a vascular ultrasound to check for blood clots. I visited an ER and had the test done. No clots were found but I continue to experience ringing in my ears, severe pain in my back that limits my ability to walk and breathe, swelling of various extremities, a rash (and itching), and overall inflammation. The Benadryl isn?t working nor is the OTC pain medication. My doctor has prescribed Prednisone.
48 2021-04-20 axillary mass I woke up Friday morning the 8th I felt a bump under my arm and called my urgent care, no one could ... Read more
I woke up Friday morning the 8th I felt a bump under my arm and called my urgent care, no one could give me info. The bump was hurting me so I went to my Dr and she sent me to get a mammogram which came out normal and you could see the bump ultrasound. I still feel it deep inside my arm but it is not as big as it was before. Dr did not prescribe anything, they wanted it to go down on it's own
48 2021-04-20 lymph node pain, lymph node swelling Pain in arm and shoulder, 48 hours Fever of 100.8, overnight, 24 hours Chills, overnight, 24 hours S... Read more
Pain in arm and shoulder, 48 hours Fever of 100.8, overnight, 24 hours Chills, overnight, 24 hours Swollen/painful lymph node on left side only, 48 hours
48 2021-04-20 lymph node swelling From the second week of the vaccine, I have felt asthmatic symptoms or swollen lymph nodes, confusin... Read more
From the second week of the vaccine, I have felt asthmatic symptoms or swollen lymph nodes, confusing symptoms
48 2021-04-20 swelling face became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin... Read more
became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; nauseous; light headed; chills; flu like symptoms; arm felt sore/arm at site of injection remains sore; at site of injection remains sore and itchy; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (lot number: ER8733) first dose on 30Mar2021 12:30 PM on left arm at single dose for COVID-19 immunisation. Medical history included IDDM (Type 1 diabetes mellitus) and MS (Multiple sclerosis). Patient is not pregnant. No other vaccine in four weeks. No known allergies. Concomitant medications in two weeks included Insulin for IDDM, dimethyl fumarate (TECFIDERA) for MS. Had vaccine at 12:30pm. At 3am (31Mar2021), arm felt sore and felt both nauseous and light headed as well as having chills and flu like symptoms. Went to bathroom and on way back to bed, became faint and passed out onto the floor. Patient hit chin and jaw so hard it was bleeding and obviously very sore and swollen. It's been nearly a week since that incident and arm at site of injection remains sore and itchy. She still feel nauseous at times and her face is still swollen from falling onto the floor and passing out. She was now fearful of having the second dose on 20Apr2021 as due since her reaction to 1st dose was so severe. The outcome of the events was recovering. No treatment for the events. No Covid tested post vaccination.
48 2021-04-21 lymph node swelling Pt had local reaction including a red hard lump and painful axillary lymphadenopathy
48 2021-04-21 lymph node swelling Swelling under my right arm close to my breast area, approximate size of a golf ball.
48 2021-04-21 lymph node swelling I developed pain and soreness in my left side breast where I imagine the lymph nodes to be. It felt ... Read more
I developed pain and soreness in my left side breast where I imagine the lymph nodes to be. It felt very tender and inflamed for a few days. I was getting quite worried about to go see my doctor and then I heard that this can happen post vaccine in the side of the shot. I still have some tenderness but it has improved. It was quite painful the type that?s hard to ignore.
48 2021-04-21 swelling 30 mins post-vaccination, patient complained of left hand feeling swollen and distended veins from h... Read more
30 mins post-vaccination, patient complained of left hand feeling swollen and distended veins from her reported baseline without loss of range of motion , sensation. Hands were on exam symmetrical in appearance without edema noted. Patient otherwise without complaints of wheezing, dermatological changes, SOB, itching, or pharyngeal swelling. Temp 100.4 HR 76, RR 20 and regular, BP 110/72 left arm Symptoms resolved by 4:07 PM at time of departure from site.
48 2021-04-22 lymph node swelling Patient received her first dose at 12:30pm and by the next morning, the patient had lymph nodes swol... Read more
Patient received her first dose at 12:30pm and by the next morning, the patient had lymph nodes swollen under her left arm pretty significantly. She also has swelling (a lump) at injection site. She was very concerned about getting her 2nd dose and advised to contact MD. She was applying ice packs and taking ibuprofen.
48 2021-04-22 lymph node swelling Very swolen glands in neck from about 7 days later and currently still swolen. Causing headaches. Bo... Read more
Very swolen glands in neck from about 7 days later and currently still swolen. Causing headaches. Both glands swell to golfball size then swelling subsides to size of a grape, and then swells again. This is ongoing
48 2021-04-22 lymph node swelling Swollen Lymph Nodes in armpit of injected arm Fever Chills Fatigue
48 2021-04-22 peripheral swelling Swelling and painful to the touch under arm, just below arm pit.
48 2021-04-23 peripheral swelling 48yo F present with c/o broken capillaries with red pinpricks on L arm, onset after showering this m... Read more
48yo F present with c/o broken capillaries with red pinpricks on L arm, onset after showering this morning. Associated with mild forearm and dorsal hand swelling. Patient also notes chest tightness and fatigue. + diastolic murmur appreciated at pulmonic and tricupsid ausculation sites L forearm and dorsal hand mildly edematous w/ diffuse red pinprick purpura
48 2021-04-23 peripheral swelling Throat felt like it was closing up. Tightness in chest similar to the feel during an asthma attach.... Read more
Throat felt like it was closing up. Tightness in chest similar to the feel during an asthma attach. Neither resulted in wheezing or extreme difficulty to breath that required immediate attention. Watering of the mouth similar to when you are about to vomit (gum helped with this). Swelling of the hands, feet and legs. For my hand I could push in on the skin which would leave an indent and slowly began to fill back out. I also noticed blurry vision when trying to read while waiting my 15-20 minutes at the location. None of these required immediate medical attention and occurred fairly quickly after the injection and appeared to resolve in 3-4 hours. I reached out to my primary care provider a few days later to determine if I should get the 2nd vaccine. He indicated that it sounded like an allergic reaction and asked if I reported to VAERS.
48 2021-04-24 anaphylactic shock Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic sho... Read more
Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic shock; discomfort throat; her heart rate accelerated; flushed face; unsteady; pain; This spontaneous report from contactable consumer (patient) via a Pfizer-sponsored program. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EJ6202), first dose via an unspecified route of administration, administered in left arm on 28Feb2021 10:40 (at the age of 48-year-old) as SINGLE DOSE for covid-19 immunization. Patient was 48 years old at the time of vaccination. Medical history included partial thyroid removal allergies to iodine, shellfish and bees, she also stated that she saw an endocrinologist who put on thyroid regimen of two different medications and she had a reaction, hives and that regimen had to be discontinued. No Prior Vaccinations within 4 weeks. Concomitant medications included levothyroxine sodium (SYNTHROID) 0.1mg tablet orally once per day in the morning been taking for at least four-fives years and epinephrine (EPIPEN). On 28Feb2021 the patient had small reaction, minor anaphylactic shock, discomfort throat, her heart rate accelerated, flushed face, pain and the patient was unsteady. The patient also stated that her throat got tight Epi Pen was not administered. Clinical course of the events includes, the patient stated that, after she received the vaccine she was instructed to stay 30 minutes instead of the 15 because she was sensitive to stuff and within about 5 minutes she started feeling discomfort in her throat. and was given Benadryl, when she has anaphylactic reactions her body goes in shock. By an hour later the heart acceleration, flush, and feeling unsteady these were completely gone. Benadryl knocked her out and she went to sleep for like 4 hours, woke up and her body was just hurting, but that only lasted a couple of days. She experienced pain for two days after. Had went for 2nd dose and facility denied her due to last reaction. Has been over 3 weeks and wants to know if there is an alternative for 2nd dose of vaccine. The patient underwent lab tests and procedures which included blood cholesterol: off, heart rate: accelerated, thyroid function test: off, all on unspecified date. Outcome of the events discomfort throat, body was just hurting was recovered. Outcome of rest of the events throat anaphylaxis, flushed face got tight, heart rate increased, unsteadiness, cholesterol low, thyroid hormones decreased was unknown.
48 2021-04-24 lymph node swelling swollen lymph nodes under arm
48 2021-04-24 peripheral swelling, lymph node swelling Day1 11:39 AM after my vaccine I feel a burning sensation thru my arm. 5:00 PM I pain started thru... Read more
Day1 11:39 AM after my vaccine I feel a burning sensation thru my arm. 5:00 PM I pain started thru out my arm and neck. I drink 2 pills of Tylenol for the pain on my arm every 8 hrs. Day 2 More pain on my left arm and swollen finger and chest (cervical ) and I feel a bump in my cervical area .
48 2021-04-25 lymph node swelling, lymph node pain Awoke at approximately 2 am on 4/24 with all over joint pain concentrated in hands/ fingers, elbows,... Read more
Awoke at approximately 2 am on 4/24 with all over joint pain concentrated in hands/ fingers, elbows, shoulders, hips and lower back. Join pain was accompanied by lethargy. Pain persisted for several hours. Took ibuprofen at 9 am on 4/24 which controlled the pain until approximately 2 pm. An additional dose was taken at 2 pm which controlled the pain until it was resolved. Awoke at 9 am on 4/25 without join paint but had developed an painful lymph gland in the right arm pit and right side of neck. The pain/ swollenness of the neck gland was resolved by early afternoon. Right arm pit pain persist at the time of reporting. Daily activity is not impaired, just uncomfortable.
48 2021-04-25 peripheral swelling feel light headache(last for 2 days), nauseate(last for a day), chill(last for one day). arm swellin... Read more
feel light headache(last for 2 days), nauseate(last for a day), chill(last for one day). arm swelling and pain.
48 2021-04-26 swelling, anaphylactic reaction Anaphylaxis. Patient with a h/o anaphylaxis with sulfa experienced itchiness, hives, neck swelling,... Read more
Anaphylaxis. Patient with a h/o anaphylaxis with sulfa experienced itchiness, hives, neck swelling, lightheadedness, hoarse voice, cough, and shortness of breath that began minutes after the 1st Pfizer vaccine dose, lot EN6208. Patient was seen in ED on 3/17 and treated with prednisone and Pepcid. Patient had a return of symptoms of throat closing and shortness of breath and self-medicated with epiPen at home and was then seen by PCP on 3/18. Restarted Singulair and added Pepcid. Patient came back to ED on 3/19 with continued symptoms. On 3/19 ED visit, patient was given Benadryl, Pepcid, Solu-medrol, epinephrine IM, and albuterol inhalation. Patient was admitted to ICU for observation. Continued Benadryl, Pepcid, and Solu-medrol scheduled doses. In ICU x 48 hours without further escalation in care. No lip swelling, stridor or wheezes noted. Urticarial rash has improved. Discharged home on tapered prednisone and Pepcid.
48 2021-04-26 swelling The patient said she vomited once today (4/25/2021) and has been having excessive thirst and urinat... Read more
The patient said she vomited once today (4/25/2021) and has been having excessive thirst and urination. She has chills and dizziness. Patient received her 1st Pfizer COVID-19 vaccine dose on 4/15/21@ 1530. @ 2100 the same day she had swelling between lips and nose and she started feeling chilly. On 4/16/21 her symptoms went away. Last February she said her glucose was 211 mg/dL when she went to the ED. She said she was not diagnosed with diabetes, but she does check her blood sugar daily. The patient has excessive thirst and finds her self drinking a lot of water. The patient was wondering if vomiting a side effect of the Pfizer COVID-19 vaccine? glucose = 172 mg/dL @ 2200 Saturday night 4/24/21 glucose = 77 mg/dL @ 2330 Saturday night 4/24/21 glucose = 90 mg/dL @ 0115 4/25/21 Follow Up with Patient Around 0700 o 4/25/2021 the patient reported her thirst has come down some. Has still been drinking plenty of water but has not had any further vomiting. States she has had an issue with GI sxs since February.
48 2021-04-27 lymph node pain By the afternoon of the first dose, I was tired. At night in bed, I experienced dry mouth, brain fog... Read more
By the afternoon of the first dose, I was tired. At night in bed, I experienced dry mouth, brain fog, faint ringing in ear, tingling in hands and feet, dry eyes, some dizziness. Sensations in muscles, stomach, and bones. It felt like something is circulating around This continued each day 2-4 following this dose. I am concerned about the brain fog and tingling in hands and feet. I am on day 6, and I am experiencing more brain fog, inability to think or remember some things, pain in rib cage, collar bone, and sensitivity in lymph nodes in breasts and throat. I know experiencing longer than average side effects than others. I have seen my doctor on Monday and he is monitoring me for 2 weeks. I am a school teacher. I am concerned. I have had to take 3 consecutive days out this week and need to be at the school to administer state testing by next week. I don't understand why I was not given a good 2 weeks to overcome my effects of vaccination by the school dept. to protect myself, students, and my own family. I took the first dose because others had said that their side effects were minimal lasting only a few days. I had mine done last Thurs of the school vacation. I feel held back from doing my job as a teacher.
48 2021-04-27 lymph node swelling First day was arm pain, headache, achy feeling. Second day was swollen lymph nodes under arms, swoll... Read more
First day was arm pain, headache, achy feeling. Second day was swollen lymph nodes under arms, swollen injection site, migraine and tired to the point of exhaustion, dizzy. Third day was migraine, dizzy, nose bleed, exhausted, sleepy, rash started on neck then spread to face, chest and forearm, swollen eyes and throat, sores in mouth and on lips. Day 4 went to primary doctor. Day 5 and 6 rash starting to subside with prednisone, Benadryl.
48 2021-04-29 lymph node swelling, lymph node pain Joint swelling and pain, pain and swelling in lymph nodes behind knees, in groin, and armpits. Musc... Read more
Joint swelling and pain, pain and swelling in lymph nodes behind knees, in groin, and armpits. Muscle pain, fatigue, inflammation in hands and feet. Lasting three weeks now without improvement
48 2021-04-30 lymph node pain, lymph node swelling Swollen , pain full lymph nodes in right armpit. Also some infection like red streaking moving dist... Read more
Swollen , pain full lymph nodes in right armpit. Also some infection like red streaking moving distally down arm.
48 2021-05-01 lymph node swelling Significant arm pain at injection site that progressed to armpit and felt as though underarm was swo... Read more
Significant arm pain at injection site that progressed to armpit and felt as though underarm was swollen. This pain hurt when touching, pressing or lifting arm and breast tenderness. Blood pressure extremely high the week following vaccine which was first noticed on 3/14, as high as 140/90. Prior to vaccine blood pressure was controlled with diet. I saw Dr. on 3/20 because blood pressure readings were inconsistent. Doctor checked me and wanted to monitor pressure readings for a while. Did not prescribe medication because the blood pressure readings were inconsistent. Scheduled an appointment me to return in a month. However, on 3/21 I started experiencing heart palpitations and 3/22 heart palpitations, shortness of breath and tightness in chest and throat. I went to the ENT who determined the I had acid reflux and advised that I should return to primary care Dr. to make sure that everything was okay with my heart. I saw doctor again and the following test (acceptable) were conducted.
48 2021-05-01 peripheral swelling, swelling face Within the first hour, elevated blood pressure. Elevated glucose, headache, nausea, dizziness, diffi... Read more
Within the first hour, elevated blood pressure. Elevated glucose, headache, nausea, dizziness, difficulty catching breath, overheating from shoulders up, extreme thirst and blurry vision. Throughout the same day, continued headache, swollen face, nausea, dizziness, elevated glucose, warmth on spine, weak, kidney pain, back pain, tired and blurred vision. Next couple of days, same as above including brain fog and swelling of all 4 limbs (feet and hands). Continued highly elevated glucose above 400 for fasting reading. After 3rd day, I felt a little better but continued swelling. Still elevated glucose, pain all over body, swelling of joints, pain in joints, could think a bit better, but overall ill feeling. 1-2 weeks after, continued swelling, pain in joints, headache and continued elevated glucose.
48 2021-05-02 lymph node swelling After getting my second dose on 3/31 my under arm got extremely swollen. I called hospital to ask a ... Read more
After getting my second dose on 3/31 my under arm got extremely swollen. I called hospital to ask a nurse and was told the swelling should be gone by Sunday 4/4. As of today I still have swelling under my left arm.
48 2021-05-02 lymph node swelling At 3am I woke up with significant pain in the nodes under my arm pit. Pain at injection site. Stiff ... Read more
At 3am I woke up with significant pain in the nodes under my arm pit. Pain at injection site. Stiff neck and pressure in my head. Later that day the stiffness in neck and pressure in head went away. Swelling continued in nodes of arm and got worse. 24-48 hours I iced nodes several times during the day and starting taking Tylenol. Fatigue and nausea set in by 48 hours. 72 hours from injection the swelling decreased slightly under arm, but moved to right clavicle and neck.
48 2021-05-03 lymph node pain, lymph node swelling Swelling and soreness in the left armpit/lymph nodes for three days rolling second dose of Pfizer CV... Read more
Swelling and soreness in the left armpit/lymph nodes for three days rolling second dose of Pfizer CV-19 vaccine. Cleared up until day 7 post vaccine when upon getting allergy shots in same arm (allergy shots for tree pollen and animal dander) soreness and swelling recurred.
48 2021-05-04 guillain-barre syndrome Increased weakness - Guillain-Barre Syndrome
48 2021-05-04 lymph node swelling Large lymph node (2 inches circumference ) above collarbone, smaller lymph nodes in neck and armpit,... Read more
Large lymph node (2 inches circumference ) above collarbone, smaller lymph nodes in neck and armpit, following low-grade fever, headaches, chills, joint pains, fatigue and diarrhea on first day of vaccine.
48 2021-05-04 lymph node swelling took 2 generic Whole Foods 365 brand Acetaminophen Expiration Date: Jun2020 in Apr2021; ear crystals... Read more
took 2 generic Whole Foods 365 brand Acetaminophen Expiration Date: Jun2020 in Apr2021; ear crystals; Nausea; she wanted to make sure her not feeling well was normal; She had a really bad headache. Clarifying the headache started 1-2 hours after she got the first COVID-19 Vaccine shot; her (left) arm was really sore after she had the COVID-19 Vaccine, but she had expected that; She was still achy in her muscles, but not everywhere. She said her muscles ached from her shoulders up only.; she had a scratchy (sore) throat; she felt tired; she had a little bit of congestion; after she received the COVID-19 Vaccine that she had some clotting, and menstrual irregularities; she had a swollen lymph node in her left arm pit for the last couple days; after she received the COVID-19 Vaccine that she had some clotting, and menstrual irregularities; she had a pressure inside of her head/Her head doesn't feel well. She said she does not quite have a headache, but her head does not feel normal.; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0170), dose 1 single dose via an unspecified route of administration in the left arm on 16Apr2021 between 3:53 PM-3:55 PM (at the age of 48 years-old) for COVID-19 vaccination. Medical history included hypermobility syndrome from an unknown date and unknown if ongoing, tends to get headaches with her hypermobility issues, and those headaches felt like pain in her head. Reported she was on the hypermobility spectrum with tension headaches, vertigo positional from an unknown date and unknown if ongoing, 3-4 weeks prior to getting the COVID-19 Vaccine, she tried to take a half of a beta blocker pill to treat the benign paroxysmal positional vertigo (BPPV). She said the BPPV had cleared, and she felt better, vestibular migraine from an unknown date and unknown if ongoing had some residual dizziness from the vestibular migraines, Ehlers-Danlos syndrome from an unknown date and unknown if ongoing. She said she did not have a technical diagnosis for Ehlers-Danlos Syndrome (hypermobility) yet, and finally sees a geneticist next month. She said she was on the weaker end of the Ehlers-Danlos hypermobility spectrum disorder, and did not have a definitive diagnosis. She didn't drink alcohol, exercised every day and slept enough. The patient did not receive any previous immunization with the Pfizer vaccine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medications included cyanocobalamin (VITAMIN B-12) taken for an unspecified indication, start and stop date were not reported and ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. Cyanocobalamin and ergocalciferol were discontinued a week before she got the COVID-19 vaccine to avoid any issues.The patient experienced she had a little bit of congestion on Apr2021, she wanted to make sure her not feeling well was normal on 16Apr2021, she had a really bad headache, clarifying the headache started 1-2 hours after she got the first covid-19 vaccine shot on 16Apr2021, her (left) arm was really sore after she had the covid-19 vaccine, but she had expected that on 16Apr2021, she had a swollen lymph node in her left arm pit for the last couple days on Apr2021, after she received the covid-19 vaccine that she had some clotting, and menstrual irregularities on Apr2021, she had a pressure inside of her head/her head doesn't feel well, she said she does not quite have a headache, but her head does not feel normal on Apr2021, she was still achy in her muscles, but not everywhere. she said her muscles ached from her shoulders up onlyon 16Apr2021, she felt off/felt a little run down on Apr2021, she had a scratchy (sore) throat on Apr2021, she felt tired on Apr2021, nausea on 16Apr2021, her (left) arm was really sore on an unspecified date and swollen lymph node in her left arm pit on an unspecified date. She said it was not possible that her head pressure, and her head feeling off had anything to do with the BPPV or the vestibular migraines. She said her ear crystals had fell out since then, and what she was experiencing now must be due to the COVID-19 Vaccine. She had no fever. She only had nausea for the first 24 hours after getting the COVID-19 Vaccine. She said she had no vomiting. She said her headache had been constant since she had the COVID-19 Vaccine on 16Apr2021. The headache started 1-2 hours after she got the first COVID-19 Vaccine shot. The events did not require an emergency room or physician's office visit. The patient underwent lab tests and procedures which included blood test and urine analysis on an unknown date in Mar2021 or Apr2021: came back normal . Therapeutic measures were taken as a result of she had a really bad headache. clarifying the headache started 1-2 hours after she got the first covid-19 vaccine shot (headache). She took 2 generic Whole Foods 365 brand Acetaminophen 500mg (1000mg total): NDC Number: 42681-7076-1, Lot Number: 8HE1354B, & Expiration Date: Jun2020 in Apr2021. The events did not require an emergency room or physician's office visit. The clinical outcome of not feeling well, headache, arm was really sore, swollen lymph node, had some clotting and menstrual irregularities was recovering and not recovered for pressure inside of her head, felt off, scratchy (sore) throat , congestion, felt tired, hadn't felt 110%, recovered for nausea and unknown for achy in her muscles and ear crystals.
48 2021-05-04 lymph node swelling Swollen lymph node in left armpit, slight pain in armpit area where shot was. Lasted a few days. Did... Read more
Swollen lymph node in left armpit, slight pain in armpit area where shot was. Lasted a few days. Did not go to dr.
48 2021-05-05 lymph node swelling Heart palpitations, shortness of breath, lymph nodes swollen. I went to my PCP on 4/14 due to severe... Read more
Heart palpitations, shortness of breath, lymph nodes swollen. I went to my PCP on 4/14 due to severe shortness of breath. I went to urgent care on 4/15 for severe shortness of breath. At the urgent care the did a chest X-ray and EKG and they were both fine. The doctor prescribed a 5 day course of prednisone to calm the inflammation down in my lungs. After two days of taking the prednisone the shortness of breath was worse. On 4/19 I went to the Emergency Room because of the shortness of breath and pain in my back and sides. The doctor ordered a CT Scan of my chest and lungs and labs. The test showed no blood clots but the blood test that determines if you have a clot or that will lead a doctor to get a CT Scan was elevated. The doctor said I was basically ok because I did not have any blood clots. She said I was experiencing some type of respiratory issue. On 4/22/21 I saw an allergist to see if I had some type allergic reaction to the vaccine. My allergist said there was no way to test the components in the vaccine but he did test me for other things. On 4/26/21 I followed up with my PCP and he gave me Maloxicam and a pain medication to take if I needed it. I was in so much pain in my sides that I couldn?t put my arms down comfortably. I continued taking two Tylenol?s every 6 hours. On 4/30/21 I saw my pulmonologist to discuss my symptoms and he talked about the prednisone suppressing my immune system so the one shot that I did get won?t really cover me. He changed my inhaler earlier this year and he said he should have left it where it was because of the time of year and my allergies. My allergist put me back on symbicort and my pulmonologist agrees and he want to keep me on it until next year. I started to feel better on 5/1/2021/ . I did not get the second vaccine because I was afraid. I have never been so sick in my entire life and none of the doctors could really tell me what happened.
48 2021-05-06 peripheral swelling Broke out with bumps on upper left side of my back, left arm and hand swelling and pain in left hand... Read more
Broke out with bumps on upper left side of my back, left arm and hand swelling and pain in left hand that continues and hasn't went away.
48 2021-05-07 peripheral swelling, swelling Got really inflamed and everything again; Brown-Sequard syndrome; Brown-Sequard syndrome; Tingling i... Read more
Got really inflamed and everything again; Brown-Sequard syndrome; Brown-Sequard syndrome; Tingling in both legs; legs getting swollen; whole left side of body swelling only from under the breast down; muscles tightening on the whole left side of body only from under the breast down; continued discomfort in left leg; Swelling makes it to where her joints can't like she can't bend her knee really well; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 48-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 01Apr2021 at 10:15 (Lot Number: EN6201), as single dose, for COVID-19 immunisation. Medical history included ongoing Brown-Sequard syndrome, ongoing diabetes mellitus, COVID-19 from 14Feb2021 to 2021 (for about 3 weeks), ongoing immunodeficiency. Concomitant medication included semaglutide (OZEMPIC) for diabetes mellitus. The patient experienced Brown-Sequard syndrome exacerbation (medically significant) on 01Apr2021 with outcome of unknown, tingling in both legs (non-serious) on 01Apr2021 with outcome of unknown, legs getting swollen (non-serious) on 01Apr2021 with outcome of unknown, whole left side of body swelling only from under the breast down (non-serious) on 01Apr2021 with outcome of unknown, muscles tightening on the whole left side of body only from under the breast down (non-serious) on 01Apr2021 with outcome of unknown, continued discomfort in left leg (non-serious) on 01Apr2021 with outcome of unknown, swelling makes it to where her joints can't like she can't bend her knee really well (non-serious) on 01Apr2021 with outcome of unknown, got really inflamed and everything again (non-serious) on 21Apr2021 with outcome of unknown. Patient reported that had swelling in the areas that normally, like the left side of her back, her stomach, all the sites that basically the Brown-Sequard Syndrome that she has problems with, it just exacerbated it. Follow-up attempts are completed. No further information is expected.
48 2021-05-07 swelling face Very slight swelling of face, very mild shortness of breath. No treatment, began 30 minutes after do... Read more
Very slight swelling of face, very mild shortness of breath. No treatment, began 30 minutes after dose, lasted about 1 day.
48 2021-05-08 peripheral swelling, swelling face Symptoms & time course 03/31/21: Within 2-3 min after taking the Covid-19 Pfizer shot in my left up... Read more
Symptoms & time course 03/31/21: Within 2-3 min after taking the Covid-19 Pfizer shot in my left upper arm, my entire arm became nearly 80% immobilized ( I felt that I was going to lose my arm movement completely but it came back). In about 5 min time, I felt a strong stomach disturbance (something like stomach diarrhea) briefly for a few seconds, and then my heart rate increased suddenly a lot and I felt a strong gush of heat coming out of my face and upper half of the body, and then I started to feel unwell. I also felt moderate pressure in my ears and the head wasn't feeling well either. My hands and fingers were trembling a lot. The paramedics checked my vitals, I think the blood pressure was around 117/62 and pulse was around 85. After another 5 minutes or so, I started to feel better. For the next 2-3 hours post-vaccination, I had felt mild symptoms of headache, nausea, and sensation of cough in the throat. Few times I also felt mild sensations of chest discomfort and that I may develop some difficulty in breathing or shortness of breath, and once I also felt a mild sensation of throat moving up and down (no throat closure), and none of these symptoms had developed to that of a higher intensity such that someone else could see them happening. About 5 hours post-vaccination (i.e. around 8:30 pm) I felt that I have a reaction going on in the body which continued for an hour. About 6 hours post-vaccination (i.e. around 9:30 pm), I felt that the reaction that was occurring in the body had ended with the skin on both of my arms becoming red in color and the skin texture was looking like that of a burnt skin (I did not take a picture of the arm with skin redness). The whole-left-arm had swollen relatively more than the whole-right-arm and I also noted mild swelling in the left arm wrist and palm. Also, a large part of the muscle just above the elbow on the left arm had swollen a lot (appearing like a bump) with muscle stiffness, and this muscle bump was mildly painful if you apply pressure on to it. There were also some mildly painful nodules in the upper left arm and the arm muscles generally appeared to be hardened. The veins & some arteries also appeared more prominent in the left arm compared to the right arm. I had noted that the swelling and redness in both the arms had started to decrease after 30 min of appearing and got reduced a lot more after about 2 hours (i.e. 11:30 pm). There was also a very mild facial swelling at night and I had felt feverish for about 25 min or so. 04/01/21 Next day early morning (i.e. 6 am) I noted abdominal or stomach bloating of higher magnitude, and I wasn't feeling very well with some mild sensations of throat moving up and down and a feeling that I may develop shortness of breath but these symptoms did not develop in higher intensity and began to subside after about an hour. As the day progressed, I started to feel better and by afternoon all of the symptoms were better except that the swelling and a hive (or muscle bump) on the left arm were still present. I also had moderate soreness around the site of injection in the upper left arm. 04/02/21 Next day morning the swelling and hive (or muscle bump) in the upper left arm were getting better but had not completely gone. By the end of the day the arm swelling had mostly subsided and the large muscle bump in the upper arm had reduced in size but still present with a mild pain. The left upper arm soreness around the site of injection had reduced. 04/03/21 & 04/04/21 The hive or (muscle bump) in the upper left arm was highly reduced in size but still present with a mild pain on applying pressure. 04/05/21 I felt some minor chest discomfort and minor pain repeatedly for a few seconds during the afternoon hours while at work. These symptoms subsided by evening hours. 04/06/21 I felt a mild chest congestion with a little bit of phlem in the chest at night which then got better after an hour or so. 04/14/21 I noted a rash on the left side of the lower neck (just above the shoulder) which extended from the left-side of the neck towards the center of neck, at night (i.e. 11:45 pm). The intensity of redness had reduced in the next 30 min or so and the rash was nearly gone by the next day morning. Final outcomes: The allergic reaction symptoms that I had developed after taking the first dose of Covid-19 vaccine from Pfizer-BioNTech had mostly resolved on their own in a week. I did not take any medications to help relieve the allergy symptoms. Concerns and queries: 1) Would it be safe for me to take a second dose of Covid-19 vaccine from Pfizer-BioNTech? 2) Would an anti-allergy medication be helpful to take before receiving a second dose of Covid-19 vaccine from Pfizer-BioNTech? 3) Is it safe to receive a Covid-19 vaccine from a different company (e.g. Johnson & Johnson or Novavax)? I am presently partially vaccinated.
48 2021-05-09 lymph node swelling, swelling face, anaphylactic reaction Severe anaphylaxis- Red on face and arm (hives/itching), severe shortness of breath, and severe swel... Read more
Severe anaphylaxis- Red on face and arm (hives/itching), severe shortness of breath, and severe swelling of face and under the arms.
48 2021-05-09 peripheral swelling swollen legs and feet that doesn't go away
48 2021-05-10 lymph node swelling Pt. developed painful splenomegaly and left axillary lymphadenopathy
48 2021-05-10 oral herpes on my hands look like blisters look like chicken pocks, they are quite painful and are opened up; on... Read more
on my hands look like blisters look like chicken pocks, they are quite painful and are opened up; on my hands look like blisters look like chicken pocks, they are quite painful and are opened up; cold sores all over my mouth and is painful to talk; cold sores all over my mouth and is painful to talk; This is a spontaneous report from a non-contactable consumer. A 48-years-old female patient received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that, she had symptoms after vaccine. She had the first dose of Pfizer vaccine last Thursday. She was having like on her hands look like blisters look like chicken pocks, they are quite painful and are opened up. They started on Saturday. She was having cold sores all over her mouth and was painful to talk. On an unspecified date in Apr2021, the patient experienced on my hands look like blisters look like chicken pocks, they are quite painful and are opened up and cold sores all over my mouth and is painful to talk. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
48 2021-05-10 peripheral swelling, lymph node swelling swelling behind the knees and swelling of the veins; it had to do with blood clot warnings / it was ... Read more
swelling behind the knees and swelling of the veins; it had to do with blood clot warnings / it was some kind of clotting because of the position of the areas of swelling.; she got like three balls on the right arm; pain in her left arm from the armpit to the elbow, it was a line of pain going down the arm; the lymph nodes in left armpit got swollen; swelling behind the knees and swelling of the veins/ she had swelling under her armpit and swelling on her right arm below her elbow; This is a spontaneous report received from a contactable consumer. A 48-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 10:30 (Batch/Lot Number: ER8729) as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced it had to do with blood clot warnings / it was some kind of clotting because of the position of the areas of swelling on 15Apr2021, swelling behind the knees and swelling of the veins, swelling behind the knees and swelling of the veins/ she had swelling under her armpit and swelling on her right arm below her elbow on 12Apr2021, the lymph nodes in left armpit got swollen on 13Apr2021, pain in her left arm from the armpit to the elbow, it was a line of pain going down the arm on 14Apr2021, she got like three balls on the right arm on 15Apr2021. The patient underwent lab tests and procedures which included ultrasound scan: unknown results.She was calling because she got her shot on 12Apr2021 and then she ended up having swelling behind her knee, then she had swelling under her armpit and swelling on her right arm below her elbow. She stated that they weren't lymph nodes, and she went to the ER (EmergencyRoom) had to check and see if they were blood clots. She stated that it turns out that her veins were swollen underneath her arm. She said that was what happened after the shot and that was her first shot. She states so that's her report on what happened. She stated she got the shot in the morning so her symptoms at 6 or 7 pm that evening. She stated she went to the doctor first and then went to the hospital. She went to the doctor on the 16Apr2021 and the hospital on 16Apr2021. She stated that the swelling behind her knee went away on 20Apr2021.Tuesday, 13Apr2021 the lymph nodes in left armpit got swollen. On Wednesday, 14Apr2021, there was a pain in her left arm from the armpit to the elbow, it was a line of pain going down the arm. On Thursday, 15Apr2021 she states she got like three balls on the right arm, on her elbow on the right side. She went to the doctor on Friday 16Apr2021 she went to the ER (emergency room) because they couldn't figure out if it was some kind of clotting because of the position of the areas of swelling. She got an ultrasounds for them to check her blood flow. She stated that the pain in her left arm was going down but didn't resolve until the 22Apr2021. For the little balls on her arm, the MD (Medicne Doctor) gave her a medication for the swelling of her veins but she forgot the name and she doesn't have the paper with her. She states the balls of fluid went away between the 20Apr2021 and 22Apr2021. Everything starting going away that week.She states it had to do with blood clot warnings, and swelling under her skin had to do with the veins. Outcome of with blood clot warnings was unknown, like three balls on the right arm and pain in her left arm from the armpit to the elbow was recovered, remaining events was recovering.Therapeutic measures were taken as a result of swelling behind the knees and swelling of the veins/ she had swelling under her armpit and swelling on her right arm below her elbow, she got like three balls on the right arm.
48 2021-05-10 swelling face Left side of her face swelled up; whole cheek on the left side swelled up; Soreness when she eats, l... Read more
Left side of her face swelled up; whole cheek on the left side swelled up; Soreness when she eats, left cheek is still tender to the touch; Her jaw would get tight as if it was clamping when she eats; Tension headaches; This is a spontaneous report from a contactable consumer. A 48-year-old female consumer (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EW0161, NDC number, expiry date; unknown, this information is not on the CDC vaccine record card.), Pfizer product, Pfizer Covid Vaccine manufacturer; unspecified, via an unspecified route of administration on 19Apr2021 at 02:15 pm at single dose (Dose: Unknown strength/volume/dose injection) in right arm up by the shoulder area for covid-19 immunization (Wanted to get the vaccine to be safe from COVID). Vaccination facility type was reported as unknown. Vaccine was administered at military facility. Patient Age at Time of Vaccination in Years was unknown. Patient's medical history included hearing impairment (Additional Information for Other Conditions; She has a cochlear implant, is completely deaf. She had cochlear surgery she believes in 2012. Onset date of hearing impairment unknown), high blood pressure (Onset date unknown other than shortly after cochlear surgery), guessed she is a little bit obese (dates unspecified). AE(s) following prior vaccination were reported as 2 weeks prior to cochlear surgery she had to receive a special type of meningitis vaccine and for probably 1 week she had a 102 degree fever and swelling in her entire face. She was admitted to the hospital but they never found out why. After being in the hospital maybe by the second day she started feeling better and the swelling went down, she had no more fever; but they kept her in the hospital for a whole week. This event is why she is thinking the events after the Pfizer Covid Vaccine could be related to the Pfizer Covid Vaccine; because her reaction following the special type of meningitis vaccine was similar to the events after the Pfizer Covid Vaccine, although not exactly the same. Vaccine/Brand Name; Unknown brand name-only known as a special type of meningitis vaccine specifically for people with a cochlear implant: Lot/NDC/Expiry unknown, caller does not have this information to provide. Vaccination Date; 2 weeks prior to cochlear surgery-cochlear surgery was in 2012. Family history and relevant tests were reported as none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EW0150) NDC/Expiry: Unknown, this information is not on the CDC vaccine record card, Dose: Unknown strength/volume/dose injection to right arm, up by the shoulder area via an unspecified route of administration on 29Mar2021 at 02:45 pm at single dose for covid-19 immunization. Patient's concomitant medications included losartan from an unspecified date in 2019 to ongoing for high blood pressure, amlodipine besylate from an unknown date in 2019 to ongoing for high blood pressure. Additional vaccine administered on same date of the Pfizer product was reported as none. Prior vaccination within 4 weeks was reported as none. Consumer was calling to report side effects after receiving a dose of the Pfizer Covid 19 vaccine. She has no MI questions at this time. No details of her side effects were given. The report was not related to a study or programme. Pfizer Covid Vaccine; Dosage previously discontinued/treatment completed. Investigation assessment; no. This consumer is the patient who called regarding Pfizer Covid Vaccine. She has been administered both the first and second doses of Pfizer Covid Vaccine. She is not sure if the events she experienced following the Pfizer Covid Vaccine are related to the Pfizer Covid Vaccine. She reported tension headaches on 21Apr2021; soreness when she eats on 23Apr2021, onset time unknown, outcome improved, she can chew food without any pain, but her left cheek is still tender to the touch.; her jaw would get tight as if it was clamping when she eats on 23Apr2021, Onset time unknown. Outcome: Consumer only able to provide that tightness in jaw has stopped, further to date and outcome details unknown.; left side of her face swelled up on 26Apr2021 when it really was noticeable. Onset time unknown other than she thinks that night. Her whole cheek on the left side swelled up; but the swelling was just in the back by the jaw where the ear was, with swelling and tightness. She noticed her face started swelling up from her jaw to the ear. She has been taking Benadryl for event. By now the swelling is going down, her whole left cheek is still swollen on left side but improved. Started improving, going down on 27Apr2021. She did not read anything about left side of her face swelled up event. Asked for further information regarding the events she experienced relative to the Pfizer Covid Vaccine. Tension headaches are gone, tension headaches started easing maybe evening of 22Apr2021 and stopped probably that same evening after taking maybe a total of 4 Tylenol that day for the Tension headaches. Outcome specifics unknown other than stopped. The reported events did not require a visit to emergency room or physician's office but she has an appointment scheduled with her doctor for this coming Saturday, 01May2021. The patient was not hospitalized. Reporter seriousness for events was unspecified. The outcome of event tension headache was recovered on 22Apr2021, pain was recovering, tightness in jaw was unknown, swelling face was recovered on 27Apr2021 and cheek swelling was recovering. No follow-up attempts are needed. No further information is expected.
48 2021-05-10 swelling single supraclavicular swelling appearing 24 hours after ipsilateral intramuscular vaccine administr... Read more
single supraclavicular swelling appearing 24 hours after ipsilateral intramuscular vaccine administration; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) intramuscularly in the right arm on 05Apr2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food or other product, had not been diagnosed with COVID-19 prior to vaccination and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included lamotrigine from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number unknown) on 15Mar2021 at 12:00 (at the age of 48-years-old) for COVID-19 immunisation. On 06Apr2021 the patient experienced single supraclavicular swelling which appeared 24 hours after ipsilateral intramuscular vaccine administration. No treatment was received for the events. The clinical outcome of single supraclavicular swelling appearing 24 hours after ipsilateral intramuscular vaccine administration was reported as not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
48 2021-05-11 swelling face Both of her eyes were swollen/ could not really see from it/ her eyes were closed shut; Whole face w... Read more
Both of her eyes were swollen/ could not really see from it/ her eyes were closed shut; Whole face was swollen/ cheeks were swollen; eyes started getting puffy; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Apr2021 (Batch/Lot Number: EW0150; Expiration Date: Jul2021) (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was none. The patient's concomitant medications were not reported. The patient had side effects which was described as whole face was swollen and both of her eyes and cheeks were swollen in Apr2021. The right side was worse than the left. The patient stated that three days ago, it swelled up a little bit so she put some ice on it, but she woke up this morning and her face was literally swollen. Even yesterday it was swollen but it was not this bad. This morning like it's really really big and it's huge. Right now, her eyes were swollen. She could not really see from it. Few days ago in Apr2021, her eyes started getting puffy. She was kind of ignored it because she put ice on it. But each day it got worse and now this morning, her eyes were closed shut, both of her eyes were swollen. Right eye was more big than the left and her face, her cheeks were swollen. The outcome of events, both of her eyes were swollen/ could not really see from it/ her eyes were closed shut, whole face was swollen/ cheeks were swollen and eyes started getting puffy was not recovered. No follow-up attempts are needed. No further information is expected.
48 2021-05-12 lymph node swelling, swelling Swelling through out body but prominent on the right side. swelling in lymph nodes in right arm pit,... Read more
Swelling through out body but prominent on the right side. swelling in lymph nodes in right arm pit, and on neck and shoulder area. swelling in my face sinuses, ear, legs , breast area right side severe pain, and under right arm, neck severe pain, right arm severe pain down to tip of fingers, severe pain in left arm, hand, fingers, pain is nerve pain, then i have so much swelling it is cutting off circulation to hands, arms, whole right side of body and upper body on left side. head aches, exhaustion. I am a phone customer service representative and can not do my job right now because it hurts too much to type. I am on short term disability until the symptoms go away or get better. I am being treated with steroids, and tramadol for pain
48 2021-05-12 lymph node swelling 9 days after the shot my right shoulder is sore and sensitive to touch, but it is not at the injecti... Read more
9 days after the shot my right shoulder is sore and sensitive to touch, but it is not at the injection site. I have some swelling above my right collar bone and a swollen gland.
48 2021-05-12 peripheral swelling More than 24 hours after the vaccine, my arm was red, swollen, hot and painful. Less than 24 hours ... Read more
More than 24 hours after the vaccine, my arm was red, swollen, hot and painful. Less than 24 hours after the vaccine, my eyes began to become itchy. On the same morning I woke with the swollen, painful arm, my eyes were also swollen, red, itchy and painful. This required a visit to an urgent care facility. I was prescribed an oral steroid, antibiotic, and antihistamine as well as ice packs to be used on my injection site.
48 2021-05-12 peripheral swelling Persistent pain in arm primarily at elbow and moving to forearm. Never had this time of issue before... Read more
Persistent pain in arm primarily at elbow and moving to forearm. Never had this time of issue before. Seems slightly swollen. Going to check with doctor for inflammation/bursitis.
48 2021-05-15 lymph node swelling, lymph node pain Patient reports swollen and painful lymph nodes.
48 2021-05-15 oral herpes Bad body aches and fever- 36 hr. Ibuprofen Sore arm- ice ibuprofen still a little sore Bad dry eye ... Read more
Bad body aches and fever- 36 hr. Ibuprofen Sore arm- ice ibuprofen still a little sore Bad dry eye and mouth- 2 days after shot getting worse. Lots of liquids and lubricating eye drops.
48 2021-05-17 swelling Left neck pain/ swelling . Started almost immediately after injection. Radiated from injection up to... Read more
Left neck pain/ swelling . Started almost immediately after injection. Radiated from injection up to shoulder, up to neck. Shoulder and arm pain went away after 3 days, however neck pain has continued daily since then
48 2021-05-18 lymph node swelling, swelling Swelling observed on the neck on the same side as the vaccinated arm; Swollen in my neck like lymph ... Read more
Swelling observed on the neck on the same side as the vaccinated arm; Swollen in my neck like lymph node; I feel tight; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER COVID 19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 15:30 (Lot number: ER8733) as single dose for covid-19 immunisation at the age of 48-year-old. The patient was not pregnant at vaccination. There were no medical history and concomitant medication. No allergy to medications, food, or other products. The patient was not diagnosed with COVID 19 prior to vaccination and hasn't been tested for COVID 19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling observed on the neck on the same side as the vaccinated arm on 17Apr2021 with outcome of not recovered and no treatment received for the event. The event was reported as non-serious. It was further reported as "I had a vaccine on 06Apr, so now I felt in the left hand that, swollen in my neck like lymph node. Is it related to the vaccine because I feel tight?". The event "I feel tight" was stated in Apr2021 with outcome of unknown. The event swollen in my neck like lymph node was started on 17Apr2021 with outcome of not recovered and no treatment received for the event. No follow-up attempts are needed. No further information is expected.
48 2021-05-18 swelling face Around 8:30 in the morning of May 18 2021, my mother was not feeling well and had a headache since s... Read more
Around 8:30 in the morning of May 18 2021, my mother was not feeling well and had a headache since she got the second dose of the COVID vaccine the previous day on May 17, 2021 at 2:00pm. She decided to take 2 Tylenol pills, 500 mg each. After a few minutes of taking the pills she developed a sever allergic reaction. Her headache pain was increasing and eventually her face started to swell up immensely. Her body developed a rash and she started to feel itchy. I called 911, and the ambulance said her vitals were okay, however I decided to take her to the clinic here and they gave her another shot in her leg to "block" (as the doctor described) the reaction. Additionally, the doctors there decided to send her to the hospital right away and they did more tests that the Doctor can describe further. She did stay overnight in the hospital, and with the treatments she received, her symptoms have gone down.
48 2021-05-19 lymph node pain, lymph node swelling About 12 days after first shot, louder noises on TV hurt my ears. An hour later, I started feeling f... Read more
About 12 days after first shot, louder noises on TV hurt my ears. An hour later, I started feeling fullness in both ears. The next morning the feeling of fullness was mostly in the right ear, and noises coming from the right-side sounded like they were coming from the left. Visit to otolaryngologist confirmed conductive hearing loss in right ear with no signs of fluid or other problems. There was also some discomfort in the lower skull area. Seems like the right ear may have slightly improved at this point, although that hasn't been confirmed. After 2nd shot, it initially seemed like there was little reaction other than painful swelling under left arm (the one the shot was given in). Since then, there has been gradual increasing fullness/pain in left ear, mostly the left lower-side of my skull. 3 weeks after the second dose, the feeling in the left ear, and surrounding area, has gone from fullness to pain. Apparently ear doctors are seeing an uptick in cases of sudden hearing loss, etc., but this reaction is not on the official reportable side effect list.
48 2021-05-19 lymph node swelling, neck mass Lump in right side of neck (possibly a lymph node); Lump in right side of neck (possibly a lymph nod... Read more
Lump in right side of neck (possibly a lymph node); Lump in right side of neck (possibly a lymph node); This is a spontaneous report from a contactable consumer (patient). A 48-year-old female (no pregnant) received the second dose of BNT162B2 via an unspecified rout of administration on the left arm on 30Apr2021 at 10:00 (Lot Number: EW0179) as single dose for COVID-19 immunization. Medical history included migraines with auras, vertigo, arthritis in knee and eczema. The patient had not been tested for COVID-19 since the vaccination and was not diagnosed with COVID-19 prior to vaccination. The patient do not received any other vaccines 4 weeks prior to the COVID vaccine. The patient's known allergies was none. Concomitant medication included ibuprofen and erenumab aooe (AIMOVIG). The patient previously took the first dose of BNT162B2 on Apr2021 at 10:00 AM (Lot Number: EW0150) on left arm for COVID-19 immunization. On 14May2021 at 16:00, the patient experienced lump in right side of neck, possibly a lymph node. This was opposite the arm the injections were given. It was not noticed until 14May. It was visible when looking at the patient's neck. Treatment was not taken. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained
48 2021-05-19 lymph node swelling Following the first vaccine I felt flu like for over a week then I had a 16 day long cycle. I have n... Read more
Following the first vaccine I felt flu like for over a week then I had a 16 day long cycle. I have not had a cycle longer than two days for over 5 years. I continued to feel exhausted and sick but it was tolerable until the second vaccine. After that one I have dizziness, nausea, headaches, no appetite, insomnia, horrible night sweats, stinky sweat, chest pain, hot flashes, can't think straight, high glucose, and swollen glands in my neck.
48 2021-05-19 peripheral swelling, swelling Nearly exactly 2 weeks after my second dose, I've begun to have muscle and joint stiffness in my leg... Read more
Nearly exactly 2 weeks after my second dose, I've begun to have muscle and joint stiffness in my legs and hands. My feet and hands feel numb at times and it feels as if I'm retaining water or swollen. My ankles, knees, leg muscles, wrists, hands and fingers are encountering this. I've never had this issue before in my entire life.
48 2021-05-19 peripheral swelling huge blood clot in her neck and a huge one in her left arm; her arm had swollen up at the elbow and ... Read more
huge blood clot in her neck and a huge one in her left arm; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 07May2021 (received at 48-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included fibromyalgia, colon cancer/postchemo from 2018, APS (antiphospholipid syndrome), arthritis and allergy to sulfa drugs. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. She was not pregnant. Concomitant medication(s) included pregabalin (LYRICA) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; oxybutynin (OXYBUTYNIN) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VIT B12) taken for an unspecified indication, start and stop date were not reported. Past drug history included known allergies to naproxen and oxycodone. The patient previously received the first dose of bnt162b2 (BNT162B2, Lot Number: EW0161), administered in Arm Right on 16Apr2021 12:00 for COVID-19 immunisation. The patient got her second dose of the Pfizer vaccine on Friday, 07May2021. By Monday evening, 10May2021, her arm had swollen up at the elbow and was red, painful and warm to the touch. After appointment she had on Tuesday, 11May2021, she went to the ER (emergency room) as it had gotten worse and confirmed she has a huge blood clot in her neck and a huge one in her left arm. She was put on permanent blood thinners after following up with my PCP (primary care physician). The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). As corrective treatment, the patient received Lovenox, Wafarin, Zarelto. Outcome of the events was recovered with sequelae on an unspecified date in May2021. The adverse events were assessed as life-threatening.
48 2021-05-19 swelling Severe eczema and rash on both hands, arms, face, neck, and leg., debilitating on hands, swelling, t... Read more
Severe eczema and rash on both hands, arms, face, neck, and leg., debilitating on hands, swelling, throbbing, puss, intense pain, unable to sleep. Itchy rash out of control. no creams or meds helping. eventually went to doctor and received 6 prescriptions and a shot. Very long slow process to recovery, still not fully recovered. Intense itching, bleeding, swelling, unable to hold coffee cup. Rash over large areas of the body.
48 2021-05-20 peripheral swelling It was given in the Left arm, my arms is still stiff, it's nearly 4 weeks now. There is a band of s... Read more
It was given in the Left arm, my arms is still stiff, it's nearly 4 weeks now. There is a band of swelling. My Left arm is not symmetrical with my Right arm. Also I had two extra migraines then I was expecting in the past 4 weeks. They did not respond to Zomig, Phenergan, or the three preventative medications I take Cyclobenzaprine, Nadolol, and Topamax. After 2 weeks, I took a series of Methylprednisone (I gave it two weeks so the vaccine could work first). The swelling reduced, but did not go away. It is still hard to raise my arm over my head. I am following up with my MD. But I thought you should know about this. I will probably switch to J&J after this, for booster shots. I'm not sure I can handle this side effect again. I would not describe it as "minor" because it's lasting so long.
48 2021-05-21 peripheral swelling Left arm and hand swelling; shingles; kidney pain; This is a spontaneous report from a contactable c... Read more
Left arm and hand swelling; shingles; kidney pain; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 09Mar2021 11:00 (batch/lot number: EN6206) as 2nd dose, single for covid-19 immunisation. Medical history included breast cancer and Lyme's disease. The patient was not pregnant. Concomitant medication included trastuzumab (HERCEPTIN). The patient received first dose of bnt162b2 on 16Feb2021, 01:00 for covid-19 immunisation. On 09Mar2021 17:00, the patient experienced left arm and hand swelling, shingles and kidney pain. The events were considered serious due to disability. The patient received treatment for the events. The patient underwent lab tests and procedures which included ultrasound with unknown results on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events was not recovered.
48 2021-05-24 peripheral swelling I noticed my feet swelling a couple day after, then I was very tired but I thought it was my monthly... Read more
I noticed my feet swelling a couple day after, then I was very tired but I thought it was my monthly cycle, then I was so tired that I couldn't walk up the stairs. Now each time I take a step I have to stop to rest before I take another step, I am out of breath. I have nausea, and feel like I want to throw up after eat, I did not relate the symptoms that it could be related to the vaccine at first and did not go to the doctor. I have headaches and very tired. And now it's getting worse and I cannot walk.
48 2021-05-25 swelling face Patient states about 1 hour after receiving pfizer Covid-19 vaccine she had left-sided facial swell... Read more
Patient states about 1 hour after receiving pfizer Covid-19 vaccine she had left-sided facial swelling and a numbing sensation of the face along with lip swelling . she complains of Left upper extremity and injection site pain .
48 2021-05-26 lymph node swelling Tinnitus after the first shot - went away in a few days Constant Tinnitus after the second shot, it'... Read more
Tinnitus after the first shot - went away in a few days Constant Tinnitus after the second shot, it's heavily affecting my sleep and ability to concentrate. Fatigue, Dizziness Swollen Lymph nodes - on left arm, it was the size of half an egg. Lymph nodes are smaller after 6 weeks but still sensitive.
48 2021-05-27 lymph node swelling It was a swollen lymph node at the base of my neck near my clavicle and it started out small but it ... Read more
It was a swollen lymph node at the base of my neck near my clavicle and it started out small but it grew about the size of a dime. You could almost see it. I decided to go to the doctor because it did not went away in a week, but it got smaller. He did not diagnosed anything but gave me Tylenol. It is gone now. I had my second shot in my second arm
48 2021-05-28 peripheral swelling my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm bec... Read more
my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; have swollen, painful and itchy eyes; have swollen, painful and itchy eyes; have swollen, painful and itchy eyes; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172 and expiration date not provided), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 17:45 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history included hypothyroidism and Anemia. The patient was not pregnant at the time of vaccination. The patient's concomitant medications included levothyroxine, ferrous sulfate, fluticasone propionate (FLONASE ALLERGY RELIEF), and ibuprofen. On 12May2021 05:30, the patient experienced arm became hot, red, swollen and painful. The patient also have swollen, painful and itchy eyes. The events cause the patient for emergency room visit. The events were treated with Oral steroid, antibiotic, antihistamine. The outcome of the events was not recovered.
48 2021-06-01 lymph node pain, oral herpes New oral herpes simplex lesion (on lip); Headache; fatigue; right arm pain; painful lymph nodes on r... Read more
New oral herpes simplex lesion (on lip); Headache; fatigue; right arm pain; painful lymph nodes on right side of neck; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient (Non-pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955, expiry date was not reported), via an unspecified route of administration, administered in arm right on 30Mar2021 13:15 single dose for covid-19 immunisation. Patient's medical history was not reported. Concomitant medication(s) included levothyroxine, famotidine, Colecalciferol taken for an unspecified indication, (within 2 weeks of vaccination) start and stop date were not reported. Patient had no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Patient previously took vaccine included BNT162B2 on 10Mar2021 13:15 single dose for covid-19 immunisation. The patient experienced right arm pain on 30Mar2021, painful lymph nodes on right side of neck, On 31Mar2021 headache, fatigue, new oral herpes simplex lesion (on lip) on 06Apr2021 10:00. The patient received treatment for the event new oral herpex simplex lesion that included One dose Valacyclovir 2g. No Covid Prior Vaccination. No Covid tested Post vaccination. The outcome of all the events are recovering except the event "new oral herpes simplex lesion (on lip)" was not recovered. No Follow-up Attempts are needed.
48 2021-06-02 swelling I started with a hard and red raised spot. It lasted 10 days but slowly went down to just a light re... Read more
I started with a hard and red raised spot. It lasted 10 days but slowly went down to just a light red. Today is day 13 and now it it back with what looks like hives or welts. It is quite painful and warm to the touch. It is around a quarter to 50 cent piece size.
48 2021-06-03 axillary mass Pain in arm and armpit; Pain in arm and armpit; Sore neck and jaw; Sore neck and jaw; Tongue very se... Read more
Pain in arm and armpit; Pain in arm and armpit; Sore neck and jaw; Sore neck and jaw; Tongue very sensitive and still sensitive; Now I have a knot in my armpit that is very tender; Now I have a knot in my armpit that is very tender; Headache; tired; irritable; My back hurt for days; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266), via an unspecified route of administration, administered in arm right on 18Feb2021 at 16:30 (at an age of 48-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. She had known allergies and had other medical history. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration, administered in arm right on 28Jan2021 at 16:15 as 1st dose, single dose for COVID-19 immunisation. She did not take other vaccine in four weeks. She had taken other medications in two weeks. Patient not had COVID prior vaccination and not had COVID tested post vaccination. On 18Feb2021 at 18:00, the patient experienced pain in arm and armpit, pain in arm and armpit, sore neck and jaw, sore neck and jaw, tongue very sensitive and still sensitive, now she had a knot in her armpit that is very tender that won't go away, headache, tired, irritable, her back hurt for days. The patient did not receive any treatment for the events. The clinical outcome of the pain in arm and armpit, pain in arm and armpit, sore neck and jaw, sore neck and jaw, tongue very sensitive and still sensitive, now she had a knot in her armpit that is very tender that won't go away, headache, tired, irritable, her back hurt for days were resolving. No follow-up attempts are possible. No further information is expected.
48 2021-06-05 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: D... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Patient was transported to Emergency Department, after 1 dose of epinephrine was given by EMT in store.
48 2021-06-06 lymph node swelling I went to chemo therapy in 2018 for colon cancer after colon resection surgery. During chemo my firs... Read more
I went to chemo therapy in 2018 for colon cancer after colon resection surgery. During chemo my first port failed and caused a huge blood clot in my neck and left arm. I have had three other events in my life of having blood clots, I did not know getting the vaccine would make me so susceptible for more. I got a huge blood clot in my neck and another one in my left arm after receiving the vaccination, my left arm swelled up huge at the elbow, with pain. Blood clots are not always painful for me, depends on where it?s at. I also have swollen lymph nodes in my armpits from the vaccine, confirmed by my oncologist. I went to the ER for the blood clots and again returned two days later to make sure I did not have PE, however the nodules in my lungs had enlarged and my lymph nodes are swollen. This is well after two weeks after I got the second dose of the vaccine, however, the blood clots take time to get as big as they are, so this probably started after the first injection, perhaps just got worse after the second one. I am now stuck on blood thinners forever because of this vaccine, I will not be getting any more of these shots.
48 2021-06-07 axillary mass This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient re... Read more
This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Upper Arm Right on 25 May 2021 (Batch/Lot Number: EW0187) as single dose for COVID-19 immunisation. Medical history included allergy. Concomitant medication(s) included cetirizine hydrochloride (CETIRIZINE) at 10 mg once daily taken for allergy, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for allergy, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Upper Arm Right on 27Apr2021 for COVID-19 immunisation. It was reported that the patient got Pfizer Vaccine (first and second shot), on Tuesday and the patient had under her arm like a pretty big knot. The patient stated the event started Today (27May2021). The patient just had a question about her COVID-19 Pfizer vaccine, about the side effects, is it normal to have a lump under your armpit (Further clarified as side effect after getting the vaccine). It was just persisting. The patient did not take any treatment for the event. Outcome of the event was not recovered.
48 2021-06-07 lymph node swelling loss of vision; very hard, large lump has surfaced in her left breast/originates from the lymph node... Read more
loss of vision; very hard, large lump has surfaced in her left breast/originates from the lymph node in her arm pit and runs to her nipple/Hard lump surfaced on lymph node at base of skull; very hard, large lump has surfaced in her left breast/originates from the lymph node in her arm pit and runs to her nipple/Hard lump surfaced on lymph node at base of skull; 103 fever; constant shaking; uncontrollable vomiting; dry heaving; headaches; extreme aching in back and chest; extreme aching in back and chest; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration into left arm on 17May2021 16:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation in Pharmacy or Drug Store. Medical history included allergy to bees (known allergies: Bees). The patient's concomitant medications were none (no other medications the patient received within 2 weeks of vaccination), the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient previously received first dose of BNT162B2 for COVID-19 Immunization. The patient experienced very hard, large lump has surfaced in her left breast, It is shaped like a straw, over two inches long. it originates from the lymph node in her arm pit and runs to her nipple, Hard lump surfaced on lymph node at base of skull. During 72 hours following second shot: 103 fever, constant shaking, loss of vision, uncontrollable vomiting, dry heaving, headaches, extreme aching in back and chest, all on 18May2021 08:00. the adverse event result in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures in May2021: blood test, mammogram, sonogram test with unknown results. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been has not tested for COVID-19. treatment received for the events included Bloodwork, sonogram and mammogram. Outcome of the events was not recovered. It was reported as non-Seriousness. Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect were all no. Information on the lot/batch number has been requested.
48 2021-06-07 lymph node swelling her lymph nodes on her clavicle swelled; This is a spontaneous report from a contactable consumer (p... Read more
her lymph nodes on her clavicle swelled; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration, administered in right upper arm on 26Feb2021 (also reported as 27Feb2021) 12:00 (at the age of 48 years old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No prior vaccinations within 4 weeks. On 04Mar2021 (reported as in the morning, like 9:00 AM), the patient experienced her lymph nodes on her clavicle swelled. It was reported that she received the first dose of Pfizer COVID vaccine on 27Feb2021 (also reported as 26Feb2021) on Saturday then 5 days later, her lymph nodes on her clavicle swelled and they were still currently swollen on 10Mar2021. Patient was wondering if she should get the second dose. She has a question due to having a reaction 5 days after the vaccine. Stated that her lymph nodes in her clavicle swelled, three of them swelled. One was the size of quarter and the other two were the size of a nickel. She was supposed to get the second shot in 20Mar2021. She was wondering if she should have concern regarding getting the second shot due to event that occurred. No history of all previous immunizations with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer suspect. The AEs did not require a visit to the emergency room and physician office. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
48 2021-06-09 lymph node swelling RIGHT ARMPIT PAIN, ARMPIT LYMPHADENOPATHY
48 2021-06-10 anaphylactic reaction Anaphylactic reaction treated with1 dose of epipen
48 2021-06-10 herpes virus infection Patient developed herpes rash on left foot about 1 week after vaccine.
48 2021-06-10 lymph node swelling Caller said that after her second dose, her lymph nodes swell up under her arm and then that subside... Read more
Caller said that after her second dose, her lymph nodes swell up under her arm and then that subsided.; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6202) via an unspecified route of administration in right arm on 05Mar2021 as 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9265) via an unspecified route of administration in left arm on 04Feb2021as 1st dose, single dose for COVID-19 immunization and experienced injection site pain, mobility is gone. Patient said that after her second dose, her lymph nodes swell up under her arm and then that subsided. Agent stated she had on the line and she received the full series of the Pfizer COVID-19 Vaccine back in February and still has soreness in her arm, feels like its locking up, cant elevate it past a certain degree, and can't really carry anything with her left arm. Agent states the caller reports her whole shoulder is hurting and she feels like she has lost mobility. Caller has spoken to her doctor about this. Patient stated her hand movement and gripping was okay sometimes but if she was lifting something a certain weight, she can feel the pressure in arm. Patient stated she tries to elevate her arm to comb her hair and it will be like a sharp pain. She stated sometimes she cannot lay on it and a lot of nights she is tossing and turning trying to get comfortable. Patient stated she had been calling back and forth with her doctor and online about it. She stated that she did have soreness at the injection site. Caller stated the soreness started lingering after the first dose for a few days, and then she was talking to her family members and friends who had gotten the Pfizer and Moderna shots. She stated everyone was discussing side effects and she spoke about her soreness lasting and now her mobility was gone. Patient stated she goes on a one mile walk and can feel the pressure when she is stretching her arms over her head. She stated she had an MRI scheduled for 14Jun2021 after her doctor wanted her to do physical therapy and she told her doctor she was pushing against a wall because she has not had any injuries or accidents. She states she is just trying to find out if anyone has had these symptoms and if they have lingered with the loss of her range of motion. Patient stated she thought all the events started about a week after receiving the first dose but she was unsure of the exact date. Patient stated she was afraid to do left arm again as she felt like she really wouldn't be able to move it at all after that. Patient stated her arm was like it wants to catch, like it gets caught and wants to lock up, like it gets a cramp. She was forcing herself to use her arm and it will stop her in her tracks if she tries to do too much. Patient said that the soreness in her arm went away after about 3 days, but her arm was just never got back right after the injection. Not require to visit emergency room. Patient visited Physician Office. There was no family medical history relevant to adverse event. The outcome of the event was recovered on an unspecified date in 2021.
48 2021-06-10 peripheral swelling I had the pain under the bottom of my left foot like fire that would not go out, that pain was so un... Read more
I had the pain under the bottom of my left foot like fire that would not go out, that pain was so unbearable; I could not walk, the bottom of foot was swollen; I could not walk, the bottom of foot was swollen; Weakness; My mind went blank I couldn't remember something I do all the time I just went blank; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration in deltoid right on 24May202 (Batch/Lot Number: EW0187; Expiration Date: unknown) (at the age of 48-year-old) as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date in the year 2020 to an unknown date in the year 2020. The patient's concomitant medications were not reported. The patient reported that she got the vaccine on the 24May2021 (Monday), by the 24May2021 (Monday night) "i had the pain under the bottom of my left foot like fire that would not go out, that pain was so unbearable" and that was the very same pain she had when she got the COVID the last year (2020), she had to be on round the clock medicine she could not walk, the bottom of foot was swollen just like she had the COVID last year, and there was a weakness. When I called to the doctor, the pain she was in, the doctor wanted her to go to the emergency room but she could not go to the emergency room it was so bad. When there was the weakness, she was so weak she just felt better this past Sunday (30May2021), that's how many stage it took me to come back to herself. The patient reported when the very day she got the vaccine she was at work and my mind went blank I couldn't remember something I do all the time I just went blank" and I could not remember. It was just that one shot to space the time and she was struggling couple of days after there was some struggle just remembering things all of that scary enough, but it was very concerning to the point where I could not want to take the second vaccine, that's how scary the whole experience for her. The outcome of the events was unknown. Was requested for additional information
48 2021-06-13 lymph node swelling, lymph node pain Swollen lymph nodes under left arm, tenderness.
48 2021-06-16 neck mass, swelling blood vessels to burst around eyes; severe swelling and itching in entire face, neck, ears, around e... Read more
blood vessels to burst around eyes; severe swelling and itching in entire face, neck, ears, around eyes; severe swelling and itching in entire face, neck, ears, around eyes; growths that popped up in entire neck area; Dose number 1: 08Mar2021, dose number 2: 26Mar2021; This is a spontaneous report from a contactable consumer(patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Mar2021 16:00 (Lot Number: EP6955) at her 48-year-old as 2nd dose, single dose for covid-19 immunization. The patient medical history was not reported. She was not pregnant,no known allergies, no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 on 08Mar2021 12:00 PM (Lot number: EN6208) in left arm at her 48-year-old for COVID-19 immunization. On 30Mar2021 10:00, the patient experienced severe swelling and itching in entire face, neck, ears, around eyes (causing blood vessels to burst around eyes) and growths that popped up in entire neck area that wasn't there before and still exists to date 01Jun2021. Treatment Steroids received for all events and physician office visit required. Outcome of blood vessels to burst around eyes, severe swelling and itching in entire face, neck, ears, around eyes, and growths that popped up in entire neck area was not recovered. Case was assessed as non-serious.
48 2021-06-16 swollen extremities Ache; Unable to hold her phone; Puffiness on her hands including her knuckle, wrist, palm and to her... Read more
Ache; Unable to hold her phone; Puffiness on her hands including her knuckle, wrist, palm and to her forearm; Fever; Nausea; Joint pain (Relative to knuckle); Pain in her hands and feet; Puffiness and pain in her feet; This a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: unknown) via an unspecified route of administration on 23May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. On an unknown date, the patient experienced fever, nausea, and ache. However, the worst part that the patient reported and was seeking recommendation on about the pain in her hands and feet. The patient experienced puffiness and pain in her feet went away after a week, however the pain and puffiness on her hands including her knuckle, wrist, palm and to her forearm was intolerable to the point that she was unable to hold her phone. The patient took Tylenol and other pain medications but seem not to work. There were also reports of joint pain (relative to knuckle) and injection pain but not in particular on the hand area specific to the locations she reported but having no information. The outcome of the events ache, unable to hold her phone, puffiness on her hands including her knuckle, wrist, palm and to her forearm, fever, nausea and joint pain (relative to knuckle) was unknown and recovered/resolved from puffiness and pain in her feet, pain in her hands and feet on an unknown date. Information on the lot/batch number has been requested.
48 2021-06-16 peripheral swelling she felt like she had been hit by a truck, she felt horrible; fever; chills; her hands have been puf... Read more
she felt like she had been hit by a truck, she felt horrible; fever; chills; her hands have been puffy and painful; her hands have been puffy and painful; This event started with her knuckles and then about a week ago went up to her wrist. Her hands still hurt but now it has spread up to forearms.; she can barley separate them, her fingers; hands are kind of numb but are also very painful; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 48-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/lot number and expiry date: not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 23May2021 13:15 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/lot number and expiry date: not reported) via an unspecified route of administration, administered in Arm Left, three weeks before the second dose at 12:45pm as single dose for covid-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as no. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as no. Prior Vaccinations (within 4 weeks) was reported as no. Family Medical History Relevant to AE was reported as no. Adverse events following prior vaccinations reported as no. Concomitant medications included escitalopram oxalate (LEXAPRO) 20mg once a day, taken for depression from Apr2020 to an unspecified stop date; lamotrigine (LAMOTRIGINE) 200 mg once a day , taken as a mood stabilizer from Apr2020 to an unspecified stop date. On an unspecified date in May2021, the patient felt like she had been hit by a truck, she felt horrible, experienced fever, chills, hands puffy and painful, hands numb but also very painful and can barely separate her fingers. The course of the events according to the reporter was ‘After the second vaccine, on the second day, she felt like she had been hit by a truck, she felt horrible. It is reported she had fever and chills and her hand and feet hurting so bad. For 2-3 weeks her hands have been puffy and painful. Little by little the symptoms went away except for her hands, the puffiness and pain is still on going. This event started with her knuckles and then about a week ago went up to her wrist. Her hands still hurt but now it has spread up to forearms. When she gets up in the morning her hands are so puffy and painful. She is taking Tylenol, Motrin, Ibuprofen. The caller also mentions she has been taking Neurontin which helps a little bit. She feels like someone is stabbing her in the hand and palm and finger and in the morning she can barely separate them, her fingers. The caller says her hands are kind of numb but are also very painful. The caller confirms at this point all the events have resolved, they lasted about 5-6 days after starting except the issues with her hands.' The outcome of the event ‘felt like she had been hit by a truck, she felt horrible', fever, chills was reported as recovered. The outcome of the events hands puffy and painful, hands numb but also very painful and can barely separate her fingers was reported as not recovered. Relevant tests reported as no. The events did not result in visit to emergency room or physician office. Therapeutic measures were taken as a result of events. Information about batch/Lot number has been requested.
48 2021-06-16 swelling face, neck mass, swelling after 4 weeks still have lump on neck; next morning swelling and redness was in neck.; next morning ... Read more
after 4 weeks still have lump on neck; next morning swelling and redness was in neck.; next morning swelling and redness was in neck.; after 6 hours- left side of face was hot, swelled and numb feeling.; after 6 hours- left side of face was hot, swelled and numb feeling.; after 6 hours- left side of face was hot, swelled and numb feeling.; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 29Apr2021 10:00 (Batch/Lot Number: EW0172) as single dose for COVID-19 immunisation. Patient age at vaccination was 48 years old. The patient medical history was not reported. Patient was not pregnant. Concomitant medications included other medications within 2 weeks of vaccination. The patient previously took fluconazole (DIFLUCAN) and experienced allergy. Historical vaccine included 1st dose of BNT162B2 (lot number=ER8733) on 01Apr2021 in left arm for COVID-19 immunization at age of 48 years old. After 6 hours (29Apr2021 16:00)- left side of face was hot, swelled and numb feeling. Next morning (30Apr2021), swelling and redness was in neck. After 4 weeks, patient still had lump on neck. The events resulted in emergency room visit. Patient received treatment for the events included diphenhydramine hydrochloride (BENADRYL) and steroids. The events were not resolved at the time of reporting.
48 2021-06-17 herpes virus infection Herpes Virus associated vesicular rash on top of left foot, with intense, radiating itchiness, infla... Read more
Herpes Virus associated vesicular rash on top of left foot, with intense, radiating itchiness, inflammation; Herpes Virus associated vesicular rash on top of left foot, with intense, radiating itchiness, inflammation; Herpes Virus associated vesicular rash on top of left foot, with intense, radiating itchiness, inflammation; Herpes Virus associated vesicular rash on top of left foot, with intense, radiating itchiness, inflammation; redness; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0187), via an unspecified route of administration in the right arm on 02May2021 as a single dose for COVID-19 vaccination. On an unknown date 03:45 PM the patient received second dose of BNT162B2 (Lot number: EW0176), via an unspecified route of administration in the right arm on 02May2021 as a single dose for COVID-19 vaccination. Medical history included hypothyroidism. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to or since the vaccination. The patient experienced Herpes Virus associated vesicular rash on top of left foot, with intense, radiating itchiness, inflammation. On 02Jun2021 08:30 PM, intensely itchy area on top of left foot, which she thought was a bug bite. Topical Benadryl (Diphenhydramine) was applied. On 03Jun2021, two small scabs emerged (approx. 5-8mm wide) that looked like abrasion/scab from excessive scratching. 03Jun2021 - 04Jun2021 itchiness subsided. On 05Jun2021, there was visible redness, inflammation and small vesicle formation around two scabbed areas in conjunction with intense radiating itchiness extending beyond areas of visible inflammation. 05Jun2021 - 06Jun2021 inflammation, intense radiating itchiness and formation of new and larger vesicles ultimately forming a 3' rash across top of foot. On 08Jun2021 the patient consulted with primary care physician (PCP): Weeping vesicles and new vesicles formation noted. Antibiotics and topical cream prescribed, and culture performed. On 11Jun2021: second opinion with dermatologist and testing of affected area positive for Herpes virus. Antiviral medication was prescribed. Treatment for the adverse events included Cephalexin, Mupirocin and Valacyclovir. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
48 2021-06-18 lymph node swelling, peripheral swelling lymph node swelling; right ankle and foot swelling; right ankle and foot swelling; This is a spontan... Read more
lymph node swelling; right ankle and foot swelling; right ankle and foot swelling; This is a spontaneous report from a contactable consumer (patient herself). A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264), via an unspecified route of administration, administered in right upper arm on 30Jan2021 (age at vaccination: 48 years) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. She says for the second dose they didn't document the expiration date, and the code was not provided for either dose on the handwritten vaccine card. The patient's medical history included breast cancer from Sep2015, lymph nodes removed from 28Oct2015, had edema which was bad and had surgery. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EK9231, expiry date: 30Apr2021) on 11Jan2021 for COVID-19 immunization. On 02Feb2021, after the second dose, the patient had lymph node swelling where she had her surgery and not the side, she had the vaccine given on; right ankle and foot swelling. She says it was her left side lymph nodes that were removed, and under her armpit her lymph node was swollen on her right side where she got her injection, she did have a big egg sized swelling. She was told that it was normal to have swelling on the site of injection, but not normal to have her lymph nodes swollen on her left side. The reporter says she noticed that her left ankle was super swollen last night, and she was retaining a ton of water, had edema which was really bad which she usually has when she flies so wears a compression stocking on the right leg. The reporter clarifies that it was her right-side ankle, her leg and foot that were swollen, her left ankle and foot was fine. She says that she did not receive treatment, elevated her feet and kept them up. She says her ankle was back to normal, and her lymph nodes are kind of going down. She clarifies that she did get a prescription of Prednisone 20mg prescribed to her by her physician, which might have helped. She says she took her first of the Prednisone 20mg last night around 06:00PM, and then took another 20mg this morning at 09:00AM. She says it was prescribed for her to take one tablet by mouth twice a day for 3 days, then one tablet by mouth for three days, so for 6 days. She says this medication was dispensed in an orange pharmacy bottle, and they did not print code/LOT/EXP on the pharmacy label. She says that both doses were injected on her right side, in her right upper arm. The patient said that the last labs she had were 6 months ago and has no recent labs. The patient reported that she received her second dose and wanted to report that she had severe side effects that she was still working through today. The outcome of all the events was resolving. No follow-up attempts are possible. No further information is expected.
48 2021-06-18 lymph node swelling Swollen left underarm glands; Pain down the upper arm; Fever; Chills; Dizziness; Nausea; Vaccine adm... Read more
Swollen left underarm glands; Pain down the upper arm; Fever; Chills; Dizziness; Nausea; Vaccine administered in left leg; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN0207) via an unspecified route of administration in left leg (characterised as vaccine administered at inappropriate site) on 16Mar2021, at 14:00 hours, (at the age of 48-year-old) as a single dose, for COVID-19 immunisation. Medical history included high blood pressure. Prior to vaccination the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No medications were received within 2 weeks of vaccination. Since the vaccination patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 17Mar2021, the patient experienced swollen left underarm glands, pain down the upper arm, fever, chills, dizziness and nausea. The clinical outcome of the events swollen left underarm glands, pain down the upper arm, fever, chills, dizziness and nausea was not recovered at the time of this report. While it was unknown for vaccine administered at inappropriate site. No follow-up attempts are needed. No further information is expected.
48 2021-06-21 lymph node swelling I have a super swollen lymph node on my left side - neck- throat. I felt like I have a really bad c... Read more
I have a super swollen lymph node on my left side - neck- throat. I felt like I have a really bad case of mono or in a bad flare of lupus. Headache, fatigue, sore throat ,throat pain, ear pain and general feeling of ill. Felt better on June 19th and 20th. However on 21st and 22nd sore throat and a lot of drainage along with a temperature appearing on the 22nd. I thought it was getting better however lymph node is still swollen and now I have a low grade fever that is 100 with Tylenol.
48 2021-06-23 lymph node swelling Within hour of first injection, Myocarditis reaction, diarhea for days, EXTREME headaches and vagus ... Read more
Within hour of first injection, Myocarditis reaction, diarhea for days, EXTREME headaches and vagus nerve pain and feeling like I was having an allergic reaction that would not clear up. Still ongoing; brain fog, general malaise, chronic fatigue, vagus nerve issues, gut issues, still feel flu like and it has been months since i had both vaccine shots. I feel like I'm having an extreme auto immune inflammatory response that no one can help me with. Prior to this we could not pinpoint my exact auto immune disease (except lyme and co infections) but I had gotten it into a "remission like state." Prior to the vaccine I was symptom free. Everything has gotten worse again since the vaccine. Difficult to work, do daily functions etc. Also a large lymph node on back right of neck that has not bothered me since childhood was enlarged for weeks but that has gotten better.
48 2021-06-23 oral herpes About 8 - 12 hours later, headache, body aches, fatigue. Body aches 12 -24 hours - CBD oil for the b... Read more
About 8 - 12 hours later, headache, body aches, fatigue. Body aches 12 -24 hours - CBD oil for the body aches; Headaches lasted another 3 days. I didn't know if I could take anything and didn't but on called Dr. (on Monday, 15th), said I could take Tylenol and maybe I took Ibuprofen then, too. Fatigue lasted about three days too. Shortly after that, I got cold sores in my nose. And on my lips, too. I have had them (cold sores) three or four times since I've had this 2nd dose. They keep coming back. I don't get them very often otherwise - maybe one in four years. I take Acyclovir; Roman Chamomile Oil and that helps if I get those used right away. It's a virus that just isn't going away. (Doctor visit was email for the prescription.)
48 2021-06-24 c-reactive protein increased she has been experiencing on going cardiovascular, respiratory, cognitive, musculoskeletal, neurolog... Read more
she has been experiencing on going cardiovascular, respiratory, cognitive, musculoskeletal, neurologic and integumentary side effects; she has been experiencing on going cardiovascular, respiratory, cognitive, musculoskeletal, neurologic and integumentary side effects; she has been experiencing on going cardiovascular, respiratory, cognitive, musculoskeletal, neurologic and integumentary side effects; she has been experiencing on going cardiovascular, respiratory, cognitive, musculoskeletal, neurologic and integumentary side effects; she has been experiencing on going cardiovascular, respiratory, cognitive, musculoskeletal, neurologic and integumentary side effects; she has been experiencing on going cardiovascular, respiratory, cognitive, musculoskeletal, neurologic and integumentary side effects; This is a spontaneous report from a contactable consumer (Nurse-patient) via medical information team. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EJ1685), via an unspecified route of administration, administered in Deltoid Left on 22Dec2020 (at the age of 48-year-old), as 1st dose, single for covid-19 immunisation. Medical history included ongoing hyperlipidemia, ongoing vasomotor symptoms related to Menopause, ongoing allergic rhinitis and chronic allergy. Concomitant medications included Montelukast sodium (SINGULAIR) 10mg, once daily, Pravastatin sodium (PRAVACHOL) 20 mg once daily; Medroxyprogesterone acetate (PROVERA) 2.5 mg once daily and Estrogens conjugated (PREMARIN), all taken for an unspecified indication, start and stop date were not reported. Patient reported that Premarin cream, I think its I forget to measure that 0.5 was it grams. Vaginally, Its Premarin cream 0.5g vaginally and I think its 0.625. On 22Dec2020, within five minutes after vaccination, the patient experienced cardiovascular, respiratory, cognitive, musculoskeletal, neurologic, and integumentary side effects. The patient stated that she had for the first two months they worsened and then they have plateaued and were not improving. She had been out of work for three months. Investigation assessment was done. The patient lab tests included CBC, CMP, TSH, Sed Rate, CRP and then a Coronavirus Antibody test and the nucleocapsid antibody test, for all the tests the results were unknown. It was reported that everything was normal and there was no evidence of active antibodies produced from the COVID infection, which was what the nucleocapsid test showed. The CBC recommended that test to determine because she had symptoms consistent with long haulers, but she had no evidence of antibody from infection (Further clarification unknown). Reportedly, patient did not receive her second dose because she was experiencing ongoing side effects and stated that she will not. Patient asked if someone was going to check in with her periodically to see If symptoms are improving. Was Pfizer studying the people researching the people, that are having long term side effect.The patient stated that she did not take any treatment as there was no treatment to take, had not received medical care. She reported that she would not even get a doctor to see her at any of the tertiary care facility in her area. Patient wanted to report this just to make sure that Pfizer note that she experienced the side effect. It was reported that patient experienced cardiovascular, respiratory, Cognitive musculoskeletal, integumentary and neurologic side effect which were related to Pfizer-BioNTech COVID-19 Vaccine. Reporter seriousness was unspecified. The outcome of the events was unknown at the time of this report. Information on Lot/Batch number was available. Additional information has been requested.
48 2021-06-24 lymph node swelling, lymph node pain Multiple ulcers/canker sores on mouth, tongue and throat, soreness at injection site, painful swolle... Read more
Multiple ulcers/canker sores on mouth, tongue and throat, soreness at injection site, painful swollen lymph node in left armpit.
48 2021-06-26 lymph node swelling Fatigue, swollen lymph nodes/glands, blister like bumps on the back of my tongue and my throat start... Read more
Fatigue, swollen lymph nodes/glands, blister like bumps on the back of my tongue and my throat started 3 days after 1st vaccine shot. Symptoms lasted for at least 3 weeks (bumps would come and go). Had just started going down when it was time for the 2nd shot on 5/3/21. Fatigue, swollen lymph nodes/glands, blister like bumps on my tongue and the back of my throat are still present. I did go to urgent care and my ear was irritated. Was tested for covid-19, flu, strep and mono, all tests were negative. I went to my primary doctor and I have had 2 ultrasounds which showed nodules on my thyroid and supraclavicular glands. Waiting for a CT scan which my insurance hasn?t approved yet. I am in pain everyday.
48 2021-06-27 lymph node pain, lymph node swelling I had some fatigue, not major. My lymph nodes were swollen to the point that they were painful. I ma... Read more
I had some fatigue, not major. My lymph nodes were swollen to the point that they were painful. I massaged it and try to tuck an ice pack under my left arm, which I did for three days and then it started feeling better.
48 2021-06-27 lymph node swelling Swollen lymph nodes on the left side of my neck.
48 2021-06-28 peripheral swelling On day two after my shot the area where they gave me they shot was itching and had a red and hot ova... Read more
On day two after my shot the area where they gave me they shot was itching and had a red and hot oval spot around it. Through out the day it spread and I felt swollen down my arm and into my hand. I was also sore around my upper breast or armpit side. Today on day three it is still there and spreading around my arm. It is still itching and hot.
48 2021-06-28 swelling Sore arm and hand. started dwelling and hives appeared all over back of legs back face stomach botto... Read more
Sore arm and hand. started dwelling and hives appeared all over back of legs back face stomach bottom of feet. swelling was only on left side.
48 2021-06-29 lymph node pain, lymph node swelling This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant fe... Read more
This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6199), via an unspecified route of administration in the left arm on 18Mar2021 at 15:30 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included thyroid issues. Concomitant medications were not reported. The patient was allergic to penicillin and sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 15:30, the patient experienced immediate tingling in arm, wrist and hand of left arm where vaccine was given. The jaw and neck pain was experienced on left side within 5 minutes of receiving vaccine. The pain continued in neck and moved to shoulder in evening. The lymph node on left side became swollen and painful. The red bumps on back of neck, back, shoulder area appeared by evening where vaccine was given. All the symptoms were on left side, which was the side vaccine was administered. On the second day, neck and shoulder pain persisted and bumps grew in size and quantity and continued to be painful. The lymph node continued to be swollen and sore to the touch. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events tingling, jaw pain, neck pain, shoulder pain, swollen lymph node, lymph node pain and red rash was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-06-29 peripheral swelling Glands under arm sore and swollen days after vaccine; Glands under arm sore and swollen days after v... Read more
Glands under arm sore and swollen days after vaccine; Glands under arm sore and swollen days after vaccine; This is a spontaneous report from a contactable consumer or other non health care professional (patient) via Pfizer Sales Representative. A 48-year-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date (at the age of 48-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced glands under arm sore and swollen days after vaccine on an unspecified date. The outcome of all events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
48 2021-06-29 swelling pain under left arm; swelling the size of half a baseball in armpit; fatigue; headache; This is a sp... Read more
pain under left arm; swelling the size of half a baseball in armpit; fatigue; headache; This is a spontaneous report from a contactable other healthcare professional (patient) reporting herself. A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302, Expiry date was not reported), dose 2 via an unspecified route of administration, administered in left arm on 02Feb2021 (at 48-years-old) as single dose for covid-19 immunisation at hospital. Medical history included low thyroid, spondyloarthritis and fibromyalgia. The patient has allergy to celexa and zithromycin. Concomitant medications included levothyroxine, cetirizine hydrochloride (ZYRTEK), medroxyprogesterone acetate (DEPO PROVERA), ibuprofen, ascorbic acid, colecalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMIN) and apple cider vinegar gummies.The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1, intramuscular, administered in left arm on 13Jan2021 at 16:00 (Batch/Lot Number: EK9231, Expiry date was not reported) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and since vaccination the patient has not been tested for covid-19. It was reported that, on 04Feb2021, at 04:00 AM the patient experienced pain under left arm with swelling the size of half a baseball in armpit, fatigue and headache. There was no treatment received for the reported events. The outcome of the events was reported as not recovered. Follow-up attempts are completed. No further information is expected.
48 2021-06-30 swelling Swelling in neck (later diagnosed as swelling in the thyroid, more pronounced on the right side and ... Read more
Swelling in neck (later diagnosed as swelling in the thyroid, more pronounced on the right side and fever (several weeks, 4 weeks of fever - starting from 100.5 Fahrenheit and later 103.5). CT scan and blood tests revealed abnormal TSH, free T4 thryoid hormone levels. Diagnosed finally by Endocronologist as Sub-acute thyroiditis (suspected diagnosis by Urgent care visit).
48 2021-07-01 swollen extremities 48 y/o female with pmh of HTN, HLD, DM2 and bipolar disorder, transferred to ICU from the psychiatri... Read more
48 y/o female with pmh of HTN, HLD, DM2 and bipolar disorder, transferred to ICU from the psychiatric until after cardiac arrest. The patient was originally admitted on 5/22 for evaluation of bizarre behavior. She was noted to have flight of ideas, emotional instability and multiple attempts to leave the room naked. She was admitted to the floor there with behavioral health consulted for evaluation. She was then transferred to another unit on 5/27/21 for additional management, with a plan for a 90 day inpatient hold. While in the unit she was managed with a medication regimen including Thorazine, Lithium and Abilify. Medicine was consulted for management of hypertension, and Ob-Gyn was following for abnormal vaginal bleeding with work-up unable to be completed due to her mental status. ECT treatments were also started this week on 6/23, with the patient receiving her second ECT treatment this afternoon. From review of the pre-procedure note, the planned induction was with etomidate, succinylcholine, glycopyrrolate, and Brevitol (methohexital, barbiturate class); the actual MAR is not up to date with her procedural medications at the time of admission. Post treatment, the patient was noted to be conversive and in her normal state of health. This evening, nursing staff heard a loud noise from the patient's room around 1630. Upon arrival, they found her down, unresponsive and without a pulse. An ACT was called and CPR was initiated for a duration of approximately 30 minutes. Reportedly the AED display showed asystole, followed by PEA. She received a reported five rounds of epinephrine, one dose of bicarbonate, and one dose of calcium during the event. The patient was intubated during the code with a large amount of gastric contents present, concerning for aspiration. A right ankle IO was placed due to significant difficulty securing access elsewhere. ROSC was obtained with a junctional rhythm, and the patient was transferred for further management. On arrival the patient is non-responsive without any sedation running. She became hypotensive by arrival to the ICU requiring norepinephrine. On later inspection of her IO, there was suspicion for infiltration of fluids and medications around her right ankle. She has had significant secretions into her ETT since transfer. HPI as noted above. ICU course notable for hypoxic respiratory failure with ARDS likely from lung injury from cardiac arrest. She subsequently developed shock and required vasopressors. Initially the patient was noted to have brainstem reflexes, however on 6/25 the patient had an exam change with no spontaneous breaths and pupils fixed and dilated. The initial head CT following arrest was performed which showed diffuse cerebral edema with effacement of the sulci and gray and white matter differentiation consistent with severe anoxic brain injury. There was diminished ventricular size with complete effacement of the fourth ventricle and tonsillar herniation from mass effect. Neurology was consulted. The patient remained on vasopressor and mechanical ventilator support. A NM scan was performed to evaluate cerebral blood flow showed absence of effective cerebral perfusion. Neurology performed an exam and the patient was pronounced deceased at 1802 on 6/27/21 a doctor. The family was informed of the results. After discussion with family, the patient was removed from mechanical ventilator support and vasoactive medications discontinued with the family at beside.
48 2021-07-02 swelling face, swelling After 1st dose- numbness, pins and needles in my hands and feet lasted on and off the day, emailed m... Read more
After 1st dose- numbness, pins and needles in my hands and feet lasted on and off the day, emailed my doctor to check in about this before getting 2nd dose. They said this was a know reaction and I should get 2nd dose. After 2nd dose- swollen left side of my face, hot, numb feeling. went to ER. was given Steroid and Benadryl. The next morning the swelling went to my neck. And lasted as 3" lump for 5+ weeks. Now has come back as lump when began a small cold- went to the dotcor as this lump lasted 2 weeks- getting ultrasound on neck lump next week.
48 2021-07-04 anaphylactic reaction Anaphylaxis immediately following vaccine. Taken to ER from clinic. Released from ER. Two days later... Read more
Anaphylaxis immediately following vaccine. Taken to ER from clinic. Released from ER. Two days later on March 19 I was taken back to ER after 2 additional anaphylaxis episodes. I was administered epipen twice in ER on the 19th and was admitted into hospital in the CCU as ICU patient. Released on March 23. Since release from hospital I have had 6 cases of anaphylaxis requiring epipen since the vaccine- each in response to bug bites. I have never used epipen for bug bites prior to vaccine- it was manageable through Benadryl previously. I am now on 200 milligrams of Benadryl per day, 15 milligrams of prednisone. Pepcid AC twice a day. Advair once a day. This is all to keep my system from experiencing anaphylaxis. My allergies are much worse since the vaccine.
48 2021-07-06 lymph node swelling Severe body aches, joint pain, headaches, chills, diarrhea, sweating for 1.5 days. Severe headaches ... Read more
Severe body aches, joint pain, headaches, chills, diarrhea, sweating for 1.5 days. Severe headaches have continued but not as frequently. Swollen lymph nodes near right breast and under right arm (pain went away after 3 days).
48 2021-07-06 lymph node swelling After first injection I experienced fatigue for 3 days, injection site soreness, and feeling run dow... Read more
After first injection I experienced fatigue for 3 days, injection site soreness, and feeling run down. After my second injection I experienced the same symptoms plus swollen lymph nodes too. I have had unexplained blindness in my right eye starting on July 12, 2021. I'm just wanting to see if this is a possible vaccine side effect. The eye doctor says that my optic never is elevated (swollen), but doesn't know why and that is after examining an MRI of my head.
48 2021-07-06 peripheral swelling Right after the shot. I got light headed and dizzy. My arm was sore. I was fatigue. My arm had swell... Read more
Right after the shot. I got light headed and dizzy. My arm was sore. I was fatigue. My arm had swell and I had broken out in hives and rash. I had migraine. Flu symptoms
48 2021-07-07 lymph node swelling The moment the nurse injected me, I felt burning down my entire arm and a deep ache. The next mornin... Read more
The moment the nurse injected me, I felt burning down my entire arm and a deep ache. The next morning, I woke up, and the lymph nodes in my neck, clavicle, and under my arms on both sides. I had extreme pain all the way down my spine and was unable to get out of bed for a few days. I messaged my doctor and he offered steroids which I declined because of my chronic conditions. This lasted 2 weeks. Once the lymph nodes finally went down, I was left with pain in the arm and shoulder where I received the injection. Since that time I have lost the range of motion in my shoulder and have seen my Ortho on June 21, 2021 and received a Cortisone shot to help the inflammation to no avail. I am still unable to move my arm without extreme pain
48 2021-07-08 lymph node swelling Swollen lymph node over collar bone; This is a spontaneous report from a contactable consumer, the p... Read more
Swollen lymph node over collar bone; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 04Mar2021 at 14:15 (at the age of 48-year-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and sulpha allergy. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) for unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 12:00, patient experienced swollen lymph node over collar bone. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen lymph node over collar bone was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
48 2021-07-08 lymph node swelling Armpits and sides painful hurting; tenderness in breast; swollen lymph nodes; This is a spontaneous ... Read more
Armpits and sides painful hurting; tenderness in breast; swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6202), via an unspecified route of administration in the right arm on 26Feb2021 at 18:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Mar2021 at 01:00, the patient's armpits and sides were painful and hurting. The patient had tenderness in breast and the patient guessed that it might be swollen lymph nodes. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events armpits and sides painful hurting, tenderness in breast and swollen lymph nodes. The clinical outcomes of the events armpits and sides painful hurting, tenderness in breast and swollen lymph nodes were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
48 2021-07-08 peripheral swelling, lymph node swelling Under the armpit swollen ganglion; Swollen upper arm; This is a spontaneous report received from a c... Read more
Under the armpit swollen ganglion; Swollen upper arm; This is a spontaneous report received from a contactable other healthcare professional, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 as a single dose for COVID-19 immunisation. The Patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route in the left arm, on 25Feb2021 at 18:00 as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient was allergic to penicillin. Patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID-19. The patient had not received any other vaccines within 4 weeks. On 19Mar2021 at 14:00 hours, the patient experienced under armpit swollen ganglion and also had swelling in the upper arm. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was administered for the events. The clinical outcome for the events arm pit swollen ganglion and upper arm swelling were not recovered. No follow-up attempts possible. No further information expected.
48 2021-07-10 peripheral swelling Having swollen feet and swollen hands and it never subsided and also the area of injection remained ... Read more
Having swollen feet and swollen hands and it never subsided and also the area of injection remained painful.; Having swollen feet and swollen hands and it never subsided and also the area of injection remained painful.; my reaction worsen so my feet got bigger my nail got bigger on the right side on the site where i tokk the shot, right arm; I am still having adverse Psoriasis, all over my body and head sores in my head and my head visually soft and I am not at Work.; Behind my eyes is felt like something is swollen.; Pain in my joint headache and my hair appear to fall on the right side.; Pain in my joint headache and my hair appear to fall on the right side.; Pain in my joint headache and my hair appear to fall on the right side.; burn mark around my neck and shoulder; my scalp is visually soft; that was a little lowers, my potassium level in my blood matter; I was totally in allergens, allergenic; This is a spontaneous report from a contactable consumer(patient). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Right on 23Mar2021 11:28 (at age of 48 years) (Lot Number: ER2613) as single dose for covid-19 immunisation. Medical history included biopsy, Allergenic (as reported). No Family Medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Feb2021 10:20 (at age of 48 years) (Lot number: EN6203), at the right arm on both, the right arm, top of the shoulder, and shoulder area for COVID-19 immunization and experienced Vaccination site pain and Peripheral swelling. Consumer stated, "I was calling to report adverse reactions to second Pfizer vaccine and Just, I took first vaccine shot on March, I am sorry, the second vaccine shot I took on 24Mar. The first vaccine on 23Feb2021, the second was on 23Mar2021. After the first vaccine, began having swollen feet and swollen hands and it never subsided and also the area of injection remained painful for about 6 to 8 weeks so, through the second shot and then on after 23Mar, I received the second shot and my reaction worsen so my feet got bigger my nail got bigger on the right side on the site where I took the shot, right arm and then I began contacting my doctor, my doctor said if they continuing worsen for me to go to emergency and I did first go to Emergency on 07May experiencing swollen feet, pain in my joint, headache and my hair appear to fall on the right side, also just like burn mark around my neck and shoulder." Consumer further stated, "I am currently, I am on and off work till 07Mar and I have not returned back to work and I would be, I saw a Dermatologist. I am currently taking prednisone for swollen feet which is triggered by, may be immune vaccine and viral and something like that, historically that's what, it's caused for triggered by that, is my experience. I have not experience the symptoms prior to taking the shot and my, I had sores over in my head down to my ear, and behind my eyes, is felt like something is swollen, my peter cells swollen and the prednisone. I began taking 2 days ago and so I was looks like may be a small, looks like a small change at giving the side effect swollen sign, only getting down a bit but I still have many sores in my head and my scalp is visually soft". Consumer was confirmed the vaccine as COVID 19 Pfizer vaccine. Treatment for adverse effect: Consumer stated," I was given topical medication Benadryl and ointment for anti-infection ointment and I was given recently, I received prednisone, it is for auto immune reaction." Outcome for events was not recovered. Other Medication/Medical condition: Consumer stated, "My situation is not resolved at all. I still need to take a biopsy a thin biopsy. I was totally in allergens, allergenic and I still have my problem does not resolve, my peter cell swollen(Not confirm hence not captured in tab) I am still having adverse Psoriasis all over my body and head sores in my head and my head visually soft and I am not at Work." Medical test: Consumer stated," I had an MRI, I had urine analysis all of my blood count my haematology and I had a chest Exam and antigen to make sure that there was no blood clot". Date of Test: Consumer stated, "These test were on 08May, the CT was on 17May." Result of tests: Consumer stated, "I don't have all of them, recall but I can say Most of the blood count reported back to me as normal and CT reported back as no fluid or excess and so far my only test that was a little lowers, my potassium level in my blood matter." Follow-Up (29Jun2021): Follow-up attempts are completed. No further information is expected.
48 2021-07-12 axillary mass Pain at injection site. Shooting pain down arm & between fingers. Pain was excruciating. Sensatio... Read more
Pain at injection site. Shooting pain down arm & between fingers. Pain was excruciating. Sensation in the underarm area. . .felt like a lump.
48 2021-07-13 guillain-barre syndrome 7 days after my 2nd shot, I started experiencing tingling in the feet which progressed to my hands u... Read more
7 days after my 2nd shot, I started experiencing tingling in the feet which progressed to my hands until on May 11th, I couldn't walk on my own and my husband took me to Emergency at Medical Center. They transferred me to other Medical Center that same day where I had multiple blood tests, MRIs, CT scans, lumbar puncture. I spent 8 days there and was transferred to Rehab Facility for 3 weeks. They are pretty sure it is GBS. I am in a wheelchair and have started to use a walker. My fine motor skills are diminished- difficult to type, hold small objects, etc.
48 2021-07-14 lymph node swelling, swelling R neck got swollen 11 days after vaccine. Went to Urgent care and was transferred to ER. Diagnosed w... Read more
R neck got swollen 11 days after vaccine. Went to Urgent care and was transferred to ER. Diagnosed with lymphadenopathy
48 2021-07-17 lymph node swelling Blood pressure was really high/heart was racing; She had swollen lymph nodes in her lungs; Nausea, h... Read more
Blood pressure was really high/heart was racing; She had swollen lymph nodes in her lungs; Nausea, headaches, and body aches. Caller states the next week she had shortness of breath, chest pain, chest tightness, and heart palpitations; Nausea, headaches, and body aches. Caller states the next week she had shortness of breath, chest pain, chest tightness, and heart palpitations; Nausea, headaches, and body aches. Caller states the next week she had shortness of breath, chest pain, chest tightness, and heart palpitations; Nausea, headaches, and body aches. Caller states the next week she had shortness of breath, chest pain, chest tightness, and heart palpitations; nausea, headaches, and body aches. Caller states the next week she had shortness of breath, chest pain, chest tightness, and heart palpitations; nausea, headaches, and body aches. Caller states the next week she had shortness of breath, chest pain, chest tightness, and heart palpitations; Nausea, headaches, and body aches. Caller states the next week she had shortness of breath, chest pain, chest tightness, and heart palpitations; Mild body ache; Inflammation around her heart; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13May2021 12:15 (at the age of 48-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. There was no medical history (including any illness at time of vaccination) and concomitant medications. She has not had covid or any covid symptoms, did not have any underlying health concerns. Family Medical History Relevant to AE(s) was none. Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s) was none. AE(s) following prior vaccinations was none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 19Apr2021 at 14.30 (at the age of 48-years-old) (Batch/Lot number was not reported) for COVID-19 immunisation and experienced puffy, swollen, and breaking out of the face, Her face broke out and eye swell up, mainly one eye, but eyes were puffy, felt like her throat was swelling, mild headache and felt nauseous. Patient received the first dose of the Pfizer COVID vaccine on 19Apr2021 and the second dose on 13May2021. After the second dose she had nausea, headaches, and body aches. The next week she had shortness of breath, chest pain, chest tightness, and heart palpitations. She went to the emergency room and her blood pressure was really high and she thinks that this was a direct correlation to the Pfizer COVID vaccine as she had never had any health issues or high blood pressure in the past. Patient states she was also told that she had swollen lymph nodes in her lungs and the doctor said this could be due to the immune response from the vaccine. Patient states she also had inflammation around her heart. She had seen a doctor and had been referred to a rheumatologist and cardiologist. Patient would like to know if any of these symptoms have been reported. Patient would like to know if her symptoms will go away or how long will they last. The patient was informed that no information in PI regarding chest tightness, chest pain, or high blood pressure being reported as side effects from the vaccine. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine. Patient states she was taken back by her symptoms because some of these were not mentioned as being reported in the information and there had not been any public mention of the side effects she was experiencing. Patient states she's not sure how best to navigate, she's had Pfizer vaccines, her first and second, and states she's had a lot of adverse side effects to Pfizer. Patient states when she looks at potential side effects from second dose, that's when she started having these side effects, these side effects aren't listed, and she was kind of thrown off by that, in terms of the communication to the public about what they could potentially experience with this vaccine. Patient states the Pfizer vaccine is causing adverse effects on her health and financially. Patient states she was a healthy person and we don't have adequate information for her in hopes that she will get well and when. Patient states she didn't have anything going on with her before receiving the vaccine and now she had to see all these doctors and spend money in order to figure out what was going on with her. Patient states Pfizer was supposed to be doing all this research and she felt left to research along with Pfizer to figure out what was wrong with her. Patient was disappointed that she took the vaccine because the way the information was presented regarding the vaccine and the consequences of the vaccine does not sit well with her. Patient states this could cause anyone major anxiety when talking about major organs in the body being affected. Patient states her blood pressure had been sky high and they can't figure out why. Patient states she's having to go lots of different routes to figure out what's wrong with her and why, to get to the root cause of all that's been happening since she had the vaccination. Patient states as a healthy person with no pre-existing conditions, it's costing her to deal with the side effects, and not just financially, but she's concerned with her overall health, dealing with cardiologists and rheumatologists, trying to figure out what's wrong with her, and she's never had any of these side effects before. Patient states she's trying to take the best path she can, but it doesn't feel good that the vaccine is out here, and the public, she doesn't think she should be the one in several million having this side effect, states it should be a known side effect, she thinks, by now. Patient states she knows through testing is done, but these side effects, but she feels she's been misled, and they're saying everything will be great, you may have something for the first 24-48 hours, and these are the symptoms, but states, the symptoms she's having are not on the list. Patient states they are persistent, she had her second shot like 12May 2021, 13May2021, and we're about to go into July, and she's concerned at this point, and trying to figure out what's going on with her respiratory and cardio systems. Patient states her first issues were the ones listed, she had a mild headache and was feeling nauseous, but it subsided within a day. Patient states within a week of the second dose of Pfizer, she started experiencing shortness of breath, chest tightness, chest pain, palpitations, heart was racing, and it wasn't going away, to the point she ended up going to the emergency room to be seen. Patient states they had a hard time detecting what it was, states they did notice some swollen lymph nodes in her lungs and respiratory, and they felt like what they were seeing was a result of her taking the vaccine, and her body's immune system was responding in some way. Patient states they said her blood pressure was extremely high and she's never had high blood pressure in her entire life, it was shocking to her how high her blood pressure was, and they suggested to see a doctor about that as well. Patient reports the mild headache and nauseous feeling started within a couple of days, soon after second dose, but date in unknown, in May2021. Patient states, it was what she expected, she also had a mild body ache, muscle pain, with the headache, and nauseous, happened within a couple of days of the shot, and didn't last. Patient states she doesn't know the specific date of onset of the shortness of breath, chest tightness, chest pain, palpitations, heart racing, and high blood pressure, because these things started happening and she went to the emergency room. Patient confirms she was not admitted to the hospital, they just kept her in the emergency room. Patient clarifies she has not seen rheumatologist yet, but has been referred to one. Patient clarifies they told her she has enlarged lymph nodes, multiple pulmonary lymph nodes, her blood pressure they told her was 143/111, and she's never had blood pressure that high in her life, and feels like heart still has palpitations, a lot going on with that, and the doctors are noticing some inflammation around her heart. Patient confirms the symptoms of shortness of breath, chest tightness, chest pain, palpitations, heart racing, and high pressure, are not improving, and she can't say if they have worsened, or to what extent, until a medical doctor examines her, but they are persisting. Patient declines to provide tests, states she doesn't understand why Pfizer needs to know what tests she had done, and the question would be, what is Pfizer doing to help her, as a person who is taking our product to deal with the side effects, that's why she is calling. Patient states she knows agent is doing what she's supposed to, but her question is, what is Pfizer going to do for patients that are experiencing side effects from our products, because patient states her telling us what she's doing, the money she's spending, or time and efforts is for her own well being and own health, but is there something Pfizer does as part of our process to identify patients that are having adverse reactions to their products, the vaccination product being dispersed to healthy people like her, that are now experiencing health issues, as a result of our product. Patient states doctors have had to deal with her blood pressure until she can figure out what else is going on with her, still trying to get to root cause of issues, and states Pfizer does not seem to have a lot of information on the vaccine's effect on the human body and relation to the immune system. Patient states she does want to speak with the health authority to hear what they are saying about these side effects being reported because when she googles she reads there instance but are younger people, and this can't be true, that it's specific to age, that they are having these same symptoms. Patient states, she understand the need because of the mass deaths caused by the virus, but she is concerned about the accelerated rollout and there are side effects that Pfizer is saying we don't know about from people and that concerns her, that this has been approved, and we are rolling this out, and then asking them to tell Pfizer what is wrong with them, when research should be telling them what is wrong, what could potentially go wrong. Shortness of breath, chest tightness, chest pain, palpitations, heart was racing resulted in Emergency Room and Physician Office visit. The outcome of the events blood pressure was really high, shortness of breath, chest pain, chest tightness, heart palpitations was not recovered, swollen lymph nodes in her lungs, inflammation around her heart was unknown, nausea, headaches, muscle pain and mild body ache was recovered. Information about lot/batch number is requested.
48 2021-07-17 lymph node swelling Fever up to 102.3; chills; night sweats; body aches; headaches; very swollen lymph node under armpit... Read more
Fever up to 102.3; chills; night sweats; body aches; headaches; very swollen lymph node under armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 14:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included depression and anxiety. The patient did not have allergies to medications, food, or other products. Concomitant medications included duloxetine hydrochloride (CYMBALTA), lorazepam (ATIVAN), paracetamol (TYLENOL), and ibuprofen (MANUFACTURER UNKNOWN) and cyclobenzaprine hydrochloride (FLEXERIL); all from an unknown date for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 05:00, the patient experienced fever up to 102.3, chills, night sweats, body aches, headaches, very swollen lymph nodes under the armpit. All the symptoms lasted seventy-two hours with the exception of swollen lymph nodes which was on going as of eighty hours. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events fever, night sweats, chills, ache and headache was recovered on 27Mar2021 with lasting effects; while that of axillary adenopathy was not recovered at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
48 2021-07-17 peripheral swelling the area of injection remained painful; Having swollen feet and swollen hands and it never subsided;... Read more
the area of injection remained painful; Having swollen feet and swollen hands and it never subsided; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 23Feb2021 10:20 (Batch/Lot Number: EN6203) at the age of 48-years-old, at single dose for covid-19 immunisation. Medical history included biopsy, and allergenic. Patient did not have vaccines prior vaccination within 4 weeks. Patient had no other medical history of illness, had no medical history. The patient's concomitant medications were not reported. The patient experienced having swollen feet and swollen hands and it never subsided and also the area of injection remained painful for about 6 to 8 weeks (medically significant) in Feb2021. Patient was currently taking prednisone for swollen feet which was triggered by, may be immune vaccine and viral and something like that, historically that's what, its caused for triggered by that, was patient's experience. The patient underwent lab tests and procedures which included blood count was normal on 08May2021, blood test was little lowers, potassium level in blood matter, chest scan to make sure that there was no blood clot and was unknown results, CT scan (computerised tomogram) was no fluid or excess on 17May2021, Antigen test to make sure that there was no blood clot and was unknown results, MRI (magnetic resonance imaging) was unknown results on 08May2021, urine analysis all of patient's blood count patient's hematology was unknown results on 08May2021. Therapeutic measures were taken as a result of events. Patient was given topical medication diphenhydramine hydrochloride (BENADRYL) and ointment for anti-infection ointment and was given recently, patient received prednisone, it was for auto immune reaction. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
48 2021-07-17 swelling face Headache; Face swollen; This is a spontaneous report from a contactable consumer, the patient. A 48-... Read more
Headache; Face swollen; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration in the left arm on 18Mar2021 at 08:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to tree nuts and coconut. The concomitant medications included prednisone (MANUFACTURER UNKNOWN),SINGULAIR, CLARINEX and Metoprolol (MANUFACTURER UNKNOWN) for an unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in the left arm on 25Feb2021 at 08:45 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient had tested positive for COVID-19. The patient had not tested positive for COVID-19 since having the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 09.45, the patient experienced headache within hour of vaccination and on 18Mar2021 face swollen in the morning after vaccine. Therapeutic measures were taken with ice and Tylenol for the reported events. The clinical outcome of the event headache and face swollen face were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-07-19 lymph node swelling, swelling Swelling of lymph node near collar bone same side as injection; swelling up into neck and shoulder
48 2021-07-19 lymph node swelling LYMPH NODE IN NECK ON RIGHT SIDE SWOLLEN, RIGHT ARM AND LEG GOING NUMB, BLOOD PRESSURE INCREASED HAD... Read more
LYMPH NODE IN NECK ON RIGHT SIDE SWOLLEN, RIGHT ARM AND LEG GOING NUMB, BLOOD PRESSURE INCREASED HAD TO BE PUT ON BP MEDICATION, NOW NECK STILL SWOLLEN AND SWEAT GLANDS ARE CONTINUING TO BECOME INFECTED. BEEN ON CONTINUAL MEDICATION SINCE 4/17
48 2021-07-19 lymph node swelling About 6 days after I took the first Pfizer Covid-19 dose, I had right arm swelling with right axilla... Read more
About 6 days after I took the first Pfizer Covid-19 dose, I had right arm swelling with right axilla swelling that did not resolve until about few days prior to taking my 2nd Pfizer Covid-19 dose. After the 2nd dose, had right arm swelling with right axilla swelling. The arm swelling resolved but the axilla swelling did not resolve. MRI of my right axilla shows lymph nodes swelling. This right axilla/lymph node swelling still present until today 07/20/21 and It is not resolving.
48 2021-07-19 lymph node swelling My left axillary lymph nodes are swollen, and the swelling is now as big as the size of an egg, star... Read more
My left axillary lymph nodes are swollen, and the swelling is now as big as the size of an egg, starting at about 24h post-vaccine; painful depending on how I move my arm; having trouble sleeping; This is a spontaneous report from a contactable other health care professional. A 48-year-old non-pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265 and Expiration date was unknown), via an unknown route of administration in left arm, on 11Feb2021 at 17:15 (at the age of 48 year-old), as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had not had COVID prior vaccination and not tested COVID post vaccination. The patient had not received any other vaccine with in four weeks and no other medications were received within two weeks. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247 and Expiration date was unknown), via an unknown route of administration in left arm, (at the age of 48 years), on 19Jan2021 at 17:15, as single dose for covid-19 immunisation. On 12Feb2021, patient left axillary lymph nodes are swollen, and the swelling is now as big as the size of an egg, starting at about 24h post vaccine. The swelling underarm was uncomfortable and painful depending on how she moves her arm, she was also having trouble sleeping because of it and felt limited in her daily activities. Tonight, she called urgent care clinic and was told to go in to be checked out. The patient received no treatment for events, the events resulted in emergency room/department or urgent care. The outcome of the events was not recovered. Follow-up attempts completed. No further information expected.
48 2021-07-20 peripheral swelling Aching joints; Swollen and stiff fingers; Swollen and stiff fingers; Strong headache; Pain and needl... Read more
Aching joints; Swollen and stiff fingers; Swollen and stiff fingers; Strong headache; Pain and needles sensation; Left arm felt heavy and tingly throughout/Arms and legs, lips and tongue began tingling, Left side of face has sensation of paresthesia; Body racked with tremors; Dizziness; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered in Arm Left on 30Apr2021 09:00 at the age of (48-years-old) as a single dose for covid-19 immunisation. Medical history included Hashimoto's hypothyroidism from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with covid. The patient was not tested positive for covid after post vaccination. The patient did not have any allergies. Concomitant medication(s) included vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported. It was reported that after 5 min of vaccination patient left arm felt heavy and tingly throughout. 10 min later arms and legs, lips and tongue began tingling. Transferred to emergency room. Upon arrival body racked with tremors, dizziness, and nausea. Tremors lasted an hour and then subsided. Left side of face has sensation of paraesthesia still today (Tues night). On day 5 after vaccination new symptoms are experienced swollen and stiff fingers, aching joints, strong headache, waves of adrenaline rushes. Left side of face unchanged, still pain and needles sensation. The patient was recovered from Tremors. And not recovered from Left arm felt heavy and tingly throughout/Arms and legs, lips and tongue began tingling, Left side of face has sensation of paraesthesia, Dizziness, Nausea, Aching joints, Swollen and stiff fingers, Swollen and stiff fingers, Strong headache, Pain and needles sensation. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
48 2021-07-20 peripheral swelling Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injec... Read more
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: patient had severe pain and swelling in arm and sharp pains in neck. Referred her to PCP.
48 2021-07-20 swelling Significant swelling in axilla; discomfort in axilla; This is a spontaneous report from a contactabl... Read more
Significant swelling in axilla; discomfort in axilla; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 29Mar2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient had no allergies to medications, food, or other products. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN) 15 mg weekly, folic acid (MANUFACTURER UNKNOWN) 1 mg daily and ibuprofen (MANUFACTURER UNKNOWN) from an unknown date and for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021, the patient experienced significant swelling and discomfort in axilla, it did not seem to be associated with lymph nodes. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the event swelling in axilla and discomfort in axilla was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-07-20 swelling Pfizer-BioNTech COVID-19 Vaccine EUA: patient reported 12 hours after immunization lip tingling, swe... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient reported 12 hours after immunization lip tingling, swelling, shortness of breath, body aches, diaphoresis, nasal congestion, and feeling of difficulty breathing. Twelve hours after symptom onset patient presented to urgent care as symptoms were not resolving. Vital signs within normal ranges except pulse 125 beats per minute and temperature 38.0 degrees Celsius. On exam, pharyngeal swelling and posterior oropharyngeal erythema were present. Diphenhydramine, prednisone, acetaminophen were administered with improvement in symptoms and vital signs. Patient monitored, continued to improve, and discharged home stable.
48 2021-07-21 swelling face About 3 hours or so after receiving my second COVID (Pfizer) vaccine, I started experiencing facial ... Read more
About 3 hours or so after receiving my second COVID (Pfizer) vaccine, I started experiencing facial flushing, some facial swelling, redness on my chest and some mild swelling of my tongue. The flushing and redness and facial swelling lasted until Satudray May 8th and the swelling of my tongue took about 7 days to completely go away.
48 2021-07-26 swelling face sudden onset facial and tongue swelling
48 2021-07-27 high blood cell count 2 months after second shot, I had been taken to the emergency room with subdural hemmorage, stroke,... Read more
2 months after second shot, I had been taken to the emergency room with subdural hemmorage, stroke, subrachnid hemmorage, leukocytosis, cerebral venous sinus thrombosis. I would like to find out if this is related to the vaccine.
48 2021-07-27 lymph node pain, swollen extremities High Blood Pressure in the middle of the night 141/101 - night 2 after injection Swollen Armpit Lymp... Read more
High Blood Pressure in the middle of the night 141/101 - night 2 after injection Swollen Armpit Lymph Nodes both sides painful - more so on same side of injection [right arm] day 2 after injection Sore Throat and swollen tonsils day 2 after injection Cold hands/ Feet day 3 after injection Rapid heart rate day 3 after after injection
48 2021-07-27 lymph node swelling Swollen lymph node in neck on left side; Swallowing painful; Breathing slightly strained; Headache; ... Read more
Swollen lymph node in neck on left side; Swallowing painful; Breathing slightly strained; Headache; Fluctuating body temperature; Had expected amount of soreness on day 2.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 at 13:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to opioids and unbromated corn. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. Concomitant medications included a herbal allergy tincture by Allertonic. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient experienced an expected amount of soreness. On 31Mar2021 at 14:00 the patient experienced swollen lymph node in neck on left side (same side as shot) that was extreme enough to make swallowing painful and breathing slightly strained, accompanied by headache and fluctuating body temperature. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for adverse events. The clinical outcome of the event swollen lymph node in neck on left side, swallowing painful, breathing slightly strained, headache and fluctuating body temperature was recovered on 03Apr2021. No follow-up attempts are needed. No further information is expected.
48 2021-07-28 anaphylactic shock Palpitations, increased blood pressure, wheezing ,SOB within 5 minutes symptoms increase as time we... Read more
Palpitations, increased blood pressure, wheezing ,SOB within 5 minutes symptoms increase as time went on-tachycardia -epi pen administer after 15-20 mins after injection
48 2021-07-28 lymph node swelling Acute onset supraclavicular lymphadenopathy left side clavicle; This is a spontaneous report from a ... Read more
Acute onset supraclavicular lymphadenopathy left side clavicle; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ew0171) via an unspecified route of administration in the left arm on 01May2021 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history were reported as none. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LO ESTRIN FE) from an unknown date and for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ew0158) via an unspecified route of administration in the left arm on 10Apr2021 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 02May2021, the patient experienced acute onset of supraclavicular lymphadenopathy on left side clavicle. The clinical outcome of the event supraclavicular lymphadenopathy on left side clavicle was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.
48 2021-07-28 lymph node swelling I had very large painful red welts on my left arm, fever of about 100.5-101, which I took Tylenol fo... Read more
I had very large painful red welts on my left arm, fever of about 100.5-101, which I took Tylenol for, I was sick like when you have a bad cold for about 2 days, in bed sick. I had bad swollen lymph nodes, you could see them with your naked eye, in my left armpit. That swelling was very painful at first, but the pain subsided in about a week, but the significant swelling never went down. I read some stuff online that swelling of the lymph nodes is common with the vaccine, but it doesn?t go down in 12 weeks you should see a doctor. I went to the doctor for the swollen lymph nodes. They did not prescribe any medications. They just examined my lymph nodes. They did some blood work to see if this was just because of the vaccine, and they came back normal.
48 2021-07-28 swelling face Eye swelled, skin around eyes (lids and undereye) red and extreme dryness. The skin around the mout... Read more
Eye swelled, skin around eyes (lids and undereye) red and extreme dryness. The skin around the mouth and chin is swollen, very red, and very dry.
48 2021-07-29 lymph node pain, lymph node swelling Extremly fatigued; Right arm also feels swollen where injected.; Swollen right armpit with lumps. No... Read more
Extremly fatigued; Right arm also feels swollen where injected.; Swollen right armpit with lumps. Not sure if they are swollen lymph nodes. Very tender and sore.; Swollen right armpit with lumps. Not sure if they are swollen lymph nodes. Very tender and sore.; Swollen right armpit with lumps. Not sure if they are swollen lymph nodes. Very tender and sore.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 05Apr2021 at 12:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease. Concomitant medications included vitamin d (MANUFACTURER UNKNOWN) and levothyroxine sodium (LEVOXYL); both from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 22Mar2021 at 12:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation and took Codeine and Vicodin; both on unknown date for unspecified indication and experienced drug allergy Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 15:00 within three hours of vaccination, the patient experienced swollen right armpit with lumps and not sure if they are swollen lymph nodes, very tender and sore, right arm also feels swollen where injected and extremely fatigued. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events swollen lymph node, lymph node tenderness, armpit pain, fatigue and vaccination site swelling were not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
48 2021-07-29 lymph node pain, lymph node swelling swollen lymph areas - armpit area, elbows, knees. aching joints / shoulders, elbows, wrists, knees; ... Read more
swollen lymph areas - armpit area, elbows, knees. aching joints / shoulders, elbows, wrists, knees; Aching lymph areas - armpit area, elbows, knees. aching joints / shoulders, elbows, wrists, knees; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 23Apr2021 at 15:30 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included some insect bites. Concomitant medications were not provided. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 02Apr2021 at 15:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient previously took oak and pine on an unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021, the patient experienced swollen and aching lymph areas - armpit area, elbows, knees. aching joints / shoulders, elbows, wrists, knees. The clinical outcome of the events swollen and aching lymph areas - armpit area, elbows, knees. aching joints / shoulders, elbows, wrists, knees were not resolved at the time of reporting. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
49 2020-12-31 anaphylactic reaction Anaphylaxis- needed 3 doses of epinephrine before admission to ER. In ER received IV steroid and fam... Read more
Anaphylaxis- needed 3 doses of epinephrine before admission to ER. In ER received IV steroid and famotidine. Was given prescriptions for epipen and oral steroids (60mg x 5 days).
49 2021-01-03 axillary mass Golf ball size lump in armpit of injection arm; This is a spontaneous report from a contactable nurs... Read more
Golf ball size lump in armpit of injection arm; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on left arm on 19Dec2020 18:15 at SINGLE DOSE for COVID-19 immunization. There was no medical history reported. Concomitant medication included estradiol (ESTROGEN), and meloxicam. On 26Dec2020 08:00, the patient experienced golf ball size lump in armpit of injection arm. The patient did not receive treatment for the adverse event. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
49 2021-01-03 swollen extremities 12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit ... Read more
12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit to wrist. All over fatigue, joint pain, brain fog, and temp of F. Nausea and headache. 12/30 - Pain in left worse, incressed pain, redness, and swelling at injecition site. Painful swollen area in left armpit. Pain with any movement of left arm. Headache, fatigue, nausea, and muscle weakness. 12/31 - Continued pain in left arm, but improved. Continue to have pain swollen area with warmth and redness size of an orange. Headache and fatigue. 1/1 - fatigue, arm sore. Bilateral arm weakness. 1/2 - headache throughout day, not responsive to Tylenol or Advil, fatigue 1/3 - Vertigo, fatigue 1/4 - Left arm slightly sore to touch, fatigue.
49 2021-01-03 peripheral swelling I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around ... Read more
I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around the vaccine site. The next morning I had swelling of my hands, feet and legs.
49 2021-01-04 lymph node swelling difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; ... Read more
difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; axillary lymph node swelling; wrist pain and swelling/joint pain; wrist pain and swelling; muscle and joint pain; skin pain; kidney and liver pain; kidney and liver pain; dizziness; nausea; weakness; fatigue; chilling; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in right arm on 22Dec2020 14:30 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR). The patient experienced Injection site pain and swelling, axillary lymph node swelling, wrist pain and swelling, muscle and joint pain, skin pain, kidney and liver pain, dizziness, nausea, weakness, fatigue, chilling, difficulty thinking, brain fog on 23Dec2020 01:15. Symptoms lasting x 6 days. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was reported as recovering. Information about lot/batch number are requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the difficulty thinking, brain fog and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-01-04 peripheral swelling, swelling face swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle an... Read more
swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle and body aches; shortness of breath; headache/migraine; headache/migraine; runny nose; sneezing; soreness in upper and lower left arm; swelling in left arm and in both hands; This is a spontaneous report from a contactable Other HCP (patient). This 49-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EJ1685) at single dose on 28Dec2020 at 02:00 PM on left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia; skin lupus; sacroiliitis; chronic migraines; allergies to Latex, TB shot skin test, several foods, environmental things (trees, grass, pollen, cockroaches, etc.). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. Since the vaccination, the patient had not been tested for COVID-19. On 29Dec2020 at 06:15 AM, the patient experienced swelling and redness in the face, muscle and body aches, shortness of breath, fatigue, headache/migraine, runny nose, sneezing, swelling in left arm and in both hands. There was not treatment received for all the adverse events. All events considered non-serious as all not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of events was not resolved.
49 2021-01-04 peripheral swelling ON 1/1/21, DEVELOPED SWELLING ON UNDERSIDE OF LEFT ARM. DISCOMFORT IN THE AREA AND PAIN RADIATING TO... Read more
ON 1/1/21, DEVELOPED SWELLING ON UNDERSIDE OF LEFT ARM. DISCOMFORT IN THE AREA AND PAIN RADIATING TO HER LEFT BREAST. ON 1/4/21, STATES THAT THE SWELLING IS RESOLVED AND THE PAIN IS IMPROVING, BUT STILL PRESENT IN THE LEFT BREAST.
49 2021-01-06 anaphylactic reaction Anaphylactic reaction
49 2021-01-06 lymph node pain, lymph node swelling Left axillary lymph node swollen and very painful Hard to move left arm.
49 2021-01-06 lymph node swelling, lymph node pain Swollen and very painful left axillary lymph node. Hard to move the arm.
49 2021-01-06 lymph node swelling cellulitis and lymphadenitis Narrative: emp developed redness and axillary lymphadenopathy in her l... Read more
cellulitis and lymphadenitis Narrative: emp developed redness and axillary lymphadenopathy in her lt axilla
49 2021-01-06 swollen extremities Received Pfizer lot EL1284 on 12-31-2020 in right arm. That night she developed a fever and her arm... Read more
Received Pfizer lot EL1284 on 12-31-2020 in right arm. That night she developed a fever and her armpits swelled up that she was not able to put her arm down. It lasted several days.
49 2021-01-07 lymph node swelling I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in ... Read more
I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in armpit lymph nodes was the size of a very large egg. I couldn't comfortably put my arm down at my side. Pain radiated down arm to elbow, and up neck into ears. I had fever of 100.1, but took ibuprofen to try and alleviate pain. The symptoms lasted about 5 days.
49 2021-01-07 peripheral swelling, swelling face 12 hours after injection I acutely developed headache, chills, sweating, muscle aches, nausea, hand ... Read more
12 hours after injection I acutely developed headache, chills, sweating, muscle aches, nausea, hand and face swelling, swelling and tenderness around injection site, general flu-like symptoms making it difficult to sleep. I was able to go to work the next morning despite symptoms. Symptoms, other than mild soreness in arm where injected, resolved 36 hours after onset.
49 2021-01-07 swelling face EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, ... Read more
EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, she felt warm but she had a coat on and her eyes started to hurt and she felt tired but she works night shift. She felt this was normal for working the night before and having stayed up to get the vaccine. After her wait period she went to her car and remembers feeling warm for having to walk in the cold. Her right side of face became reddish purple and warm. She sat in car for a few minutes. As she drove her face started to swell and turn all red. When she arrived home she had heavy pressure middle of face-nose area. Her face continued to turn reddish purple with a rash on right side of face and down to her neck. She felt her sinuses and throat swell with irritation and in throat and wheezing. Her mom is a nurse and they waited to see if it worsen or got better. She decided since she could breath she would not go to hospital. After about 5 hours she felt much better. She continued to have a headache for 4 days. She had swelling and soreness of left arm for a couple of days. She continued to go to work.
49 2021-01-07 swelling Throat hurting , really hot Neck Swollen , back of Neck hurt really bad Joint Pains Headache
49 2021-01-08 swelling Angioedema, HYPERtension, Narrative: Lips swollen and hypertension. Lips less after 20 mins
49 2021-01-08 peripheral swelling Swollen, painful left axillary lymph nodes
49 2021-01-10 lymph node pain chills, aches, lymph pain
49 2021-01-10 lymph node pain Lymph pain, low grade fever, aches
49 2021-01-10 lymph node swelling Right armpit tender and swollen lymph nodes noted the next morning (01/10/2021) after 2nd IM injecti... Read more
Right armpit tender and swollen lymph nodes noted the next morning (01/10/2021) after 2nd IM injection administered. Fatigue and headache occurred by the same afternoon and low grade fever of 99.6° that evening at 8:30 PM. Right armpit tender and swollen lymph nodes remain present 2 days post 2nd IM injection and right arm injection site is warm to touch with redness and firmness to touch.
49 2021-01-10 lymph node swelling After the awcond vaccine: Woke up at 4 am the next morning with body aches, chills, nausea and a mi... Read more
After the awcond vaccine: Woke up at 4 am the next morning with body aches, chills, nausea and a mild headache that was intermittent. I had malaise and fatigue. I took some cold medicine 3 times in the course of 24 hours and woke up the next morning with none of those symptoms but did have lympadenopathy under my left arm that decreased through the course of the day. It was painful to touch and tender once the lymph node decreased in size. The only other reaction was the site pain and tenderness and warmth. That lasted a few days.
49 2021-01-10 lymph node swelling Swollen lymph nodes on left arm still ongoing will be seeking medical care.
49 2021-01-10 peripheral swelling Swelling to B/L hands, itching and rash to right hand. Patient advised to use OTC antihistamine and... Read more
Swelling to B/L hands, itching and rash to right hand. Patient advised to use OTC antihistamine and follow up with PCP.
49 2021-01-10 peripheral swelling Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotte... Read more
Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotten a CT contrast, where my whole body began to feel warm, also a metallic taste in my throat. A few hours later I had a horrible headache, with tightness in my chest and palpitations. My muscles and joints ached, my hands became swollen and I was unable to remove my ring. These symptoms continued for 24 hours. I also experienced shortness of breath.I almost took myself to ER. They eventually went away and I feel fine now
49 2021-01-11 lymph node swelling Lymphadenopathy in the axillary are of my left arm. I have not seen a physician regarding the lympha... Read more
Lymphadenopathy in the axillary are of my left arm. I have not seen a physician regarding the lymphadenopathy as I have no other signs or symptoms. I?ve read this was considered an adverse reaction and wanted to report it
49 2021-01-11 peripheral swelling painful swollen red arm shoulder to elbow joint and muscle pain sore throat low grade fever 99.5 nau... Read more
painful swollen red arm shoulder to elbow joint and muscle pain sore throat low grade fever 99.5 nausea vomiting shortness of breath headache some periods of confusion
49 2021-01-11 swelling, peripheral swelling Arm, shoulder, and neck swollen; shoulder and neck swollen; shoulder and neck swollen; Extremely sou... Read more
Arm, shoulder, and neck swollen; shoulder and neck swollen; shoulder and neck swollen; Extremely sour; Tender; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 49-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9232) Intramuscular at Left arm on 04Jan2021 08:00 AM at single dose for COVID-19 immunization. Medical history included known allergies to sulfa based antibiotics and a steroid. There are other medications in two weeks. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took ibuprofen and had allergy. Patient experienced arm, shoulder, and neck swollen. Extremely sour and tender on 04Jan2021 11:00 AM. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at workplace clinic. No treatment received for the events. Patient was recovering from the events. It was non serious case. Not results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating nor congenital anomaly/birth defect. Patient was recovering from the events.
49 2021-01-12 lymph node swelling, lymph node pain My adverse reaction was a hot flash for about 10min on 12/31/2020 and on 01/01/2021, I found a small... Read more
My adverse reaction was a hot flash for about 10min on 12/31/2020 and on 01/01/2021, I found a small pea size lump on my right collar bone area that has now increased in size to a quarter size lump that's mildly tender.
49 2021-01-12 lymph node swelling soft ball size lymph node under arm pit of injected arm
49 2021-01-12 lymph node swelling soft ball size swollen lymph node under at arm pit arm of injection
49 2021-01-12 peripheral swelling, lymph node swelling chills which lead to shivers and putting on 3 layers, 2 down comforters and a throw blanket to go to... Read more
chills which lead to shivers and putting on 3 layers, 2 down comforters and a throw blanket to go to sleep, fever (I can't remember what it was), sweating (even after taking layers and blankets off), fatigue, arm swelling, and pain where the injection was, nausea, unable to stand for short periods of time, This lasted over 24 hours, the next day the same but on a lesser progression but included diarrhea and a swollen supraclavicular lymph node being swollen-- > 5"x2".
49 2021-01-13 anaphylactic reaction Anaphylactic reaction requiring EpiPen 0.3, Benadryl IM and transport to Emergency Department per EM... Read more
Anaphylactic reaction requiring EpiPen 0.3, Benadryl IM and transport to Emergency Department per EMS.
49 2021-01-13 lymph node swelling Lymphadenopathy of left axillary area
49 2021-01-13 lymph node swelling swollen lymph nodes under arm
49 2021-01-13 lymph node swelling -Right hand & forearm numbness/within 10 minutes of vaccine -Fever, Bodyacheeks, headackes, -Pain on... Read more
-Right hand & forearm numbness/within 10 minutes of vaccine -Fever, Bodyacheeks, headackes, -Pain on the right side - Jaw, neck & right -Lyphnote under the right arm is swollen. -Neck & under armpit pain because of this -The night after getting the 2nd vaccine Covid I started getting chills, fever of 102+ Extreme body ackes -Right arm armpit lymph nodes swollen the size of my fist -Right side of my neck also swollen -The Right lower back hurts as well -From 1 to 10 is an 8 acute pain
49 2021-01-13 peripheral swelling, swelling face Left upper arm swelling Left facial swelling Neck pain Headache General fatigue Left leg ache Site p... Read more
Left upper arm swelling Left facial swelling Neck pain Headache General fatigue Left leg ache Site pain
49 2021-01-14 axillary mass 1/8/2021 3PM vaccination 1/9/2021 24 hours later, fever went up to 102.4. Tylenol @ 10pm. Body aches... Read more
1/8/2021 3PM vaccination 1/9/2021 24 hours later, fever went up to 102.4. Tylenol @ 10pm. Body aches, lump in armpit. *First dose; slight fever of 100 on day 3,4 and pain at injection site.
49 2021-01-14 axillary mass 1/8/2021 vaccine 1/9/2021 fever spiked to 101.4. Took tylenol @ 10pm. Body aches, lump armpit. *f... Read more
1/8/2021 vaccine 1/9/2021 fever spiked to 101.4. Took tylenol @ 10pm. Body aches, lump armpit. *first vaccination; slight fever of 100 on days 3,4.
49 2021-01-14 lymph node swelling Chills, fever, body aches, swollen lymph nodes occipital and posterior superficial cervical lymph no... Read more
Chills, fever, body aches, swollen lymph nodes occipital and posterior superficial cervical lymph nodes began afternoon 1/14/21
49 2021-01-14 swollen extremities, lymph node swelling immunization (site on the right upper arm) on 1/10/21 with increased right arm pain at rest and move... Read more
immunization (site on the right upper arm) on 1/10/21 with increased right arm pain at rest and movement, then flu like symptoms 1/11-14/21: aches, fatigue, malaise, head ache; on 1/12/21 in the afternoon I noticed right axilla pain in axilla, same level at the upper back/ribcage under the shoulder blade and corresponding pectoralis muscles and swell in axilla and upper pectoralis muscles, I could also palpitate multiple firm and tender lymph nodes at the right axilla.
49 2021-01-16 lymph node swelling Thursday 1/14/21 5:30 PM began having chills and body aches. Temperature of 102, taken by ear. Fe... Read more
Thursday 1/14/21 5:30 PM began having chills and body aches. Temperature of 102, taken by ear. Felt Strange just not well. Ran a fever through the night into the next morning., Friday 1/15/21 had a fever of 100.5 taken by ear. Fever subsided. Began having a slight headache that lasted through Sunday. Also had Nausea that started Friday and continued through today. Sunday. Injection arm has been very sore. I also have a very sore enlarged lymph node under my left arm pit. Markedly swollen.
49 2021-01-17 lymph node swelling swollen right lymph node, unable to move arm
49 2021-01-17 peripheral swelling, lymph node pain 49 y.o. female who presented to the emergency department on 1/14/21 for possible allergic reaction. ... Read more
49 y.o. female who presented to the emergency department on 1/14/21 for possible allergic reaction. Patient states that she got her first Covid vaccine yesterday afternoon and states that she has noted some swelling in her hands and also feels as though she has burning pain and pins-and-needles in her hands. She denies any weakness in her distal extremity. She states the sensation extends from her fingertips to her mid forearm. She also states that she has noted some lymph node pain in her groin and neck. She denies any fevers or chills. She denies any throat tightness, shortness of breath, wheezing, abdominal pain, nausea, vomiting or rash associated with her symptoms. Patient is alert and oriented ×3, cranial nerves II through XII intact bilaterally, no pronator drift, paresthesias in glove like distribution from hand to mid forearm bilaterally. Sensation intact in bilateral lower extremities, 5/5 strength in upper and lower extremities, cerebellar function intact with finger to nose bilaterally. No visual field deficits by confrontation. Discussed laboratory findings with patient. She did also does have a mildly elevated creatinine outside of kidney injury however suspect may be source for mildly elevated phosphorus. Given 1 L of fluids. Recommended close follow-up with PCP for laboratory recheck and further evaluation. No signs of acute anaphylaxis or angioedema. Discussed return precautions with patient if she were to have worsening symptoms
49 2021-01-17 swelling swelling, redness, warmth to touch, tenderness-this began later 1/15/2021 and continued throughout t... Read more
swelling, redness, warmth to touch, tenderness-this began later 1/15/2021 and continued throughout the weekend
49 2021-01-17 white blood cell count increased Patient experienced abdominal pain on January 12th. She reported having a headache and joint pain as... Read more
Patient experienced abdominal pain on January 12th. She reported having a headache and joint pain as well. Her temperature was 103.5. On January 14th the patient was admitted for acute appendicitis with perforation, localized peritonitis, and gangrene. Patient was discharged on January 16th post appendectomy.
49 2021-01-18 lymph node swelling Took Wednesday, by Friday under left arm was swollen, chills, body aches, migraine, low energy, tire... Read more
Took Wednesday, by Friday under left arm was swollen, chills, body aches, migraine, low energy, tiredness, couldn't get up, Sunday felt same way and called in to work, Monday weakness in both legs, went to work, today under arm is still sore. When i rub on deodorant underarm is very sore, left arm feels funny. Today still have migraine, i started Tylenol on Thursday, by Friday evening i was taking tylenol every 6 hours until yesterday. I used medicated over the counter pouch, put hot cloth under arm for swelling and it did go down some, but is still not back to normal. Everything i was feeling was on my left side, by Saturday whole body was aches, continued taking tylenol but now just left arm is sore. Migraine comes and goes. My doctor told me this morning she experienced everything i told her.
49 2021-01-18 swelling Lower part of my head is swollen in the back; This is a spontaneous report from a contactable consum... Read more
Lower part of my head is swollen in the back; This is a spontaneous report from a contactable consumer (patient, "I am Dental"). A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included none. Concomitant medication included hydrochlorothiazide, famotidine, and montelukast. The patient experienced lower part of head was swollen in the back on 07Jan2021. The patient stated, "I got my first vaccine on 22nd (22Dec2020) and I been feeling fine until this morning when I woke up and lower part of my head is swollen in the back so I don't know it's something related or not." Patient also stated, "Because I am in healthcare and I deal with lot of saliva all day working on teeth." No treatment received for the event. The outcome of the event was not recovered.
49 2021-01-18 swelling Dose #1, Day 2-Approx 24hrs after IM injection started with finger joint swelling/pain/limited ROM a... Read more
Dose #1, Day 2-Approx 24hrs after IM injection started with finger joint swelling/pain/limited ROM and difficulty grasping items by end of day. Day #3 Fingers improving. Day 4 Knees swollen and difficulty bending or climbing stairs, resolved by Day 5. Dose #2, Day 1- 12 hrs after injection started with joint stiffness in hands. Day #2 Finger joint swelling/pain. Day #3 finger,hand,shoulder,hip,knee and metatarsal pain/swelling/limited ROM. Day #4 (same as Day 3), DAY 5,6,7 symptoms improving: able to complete 12 hr shift at work. Day 8 finger/hand joint swelling/pain/stiffness
49 2021-01-18 swelling Severe/Explosive diarrhea for 3 days now, extreme GI pain, bloating, swelling, loss of appetize, fa... Read more
Severe/Explosive diarrhea for 3 days now, extreme GI pain, bloating, swelling, loss of appetize, fatigue, low back pain and achy all over. Much more severe then after my 1st Covid shot.
49 2021-01-19 lymph node pain, swelling : TM received a COVID 19 #1 vaccine on 1/11 to the left deltoid. She had arm soreness, headache and ... Read more
: TM received a COVID 19 #1 vaccine on 1/11 to the left deltoid. She had arm soreness, headache and fatigue following the vaccination. Those symptoms lasted a few days and resolved. On 1/17 she noticed a sore area under her left arm. she has a small firm painful lymph node under the left arm. She also noticed that she has a slight " fullness" in the neck area. She feels like her thyroid gland is more pronounced. than it was prior to the vaccine. She denies any dysphagia or odynophagia. No SOB or tachypnea. No fever or chills. No hx of thyroid dysfunction.
49 2021-01-19 peripheral swelling "I received the Pfizer Covid vaccine Wed afternoon around 4pm. Thursday morning around 9:30 I starte... Read more
"I received the Pfizer Covid vaccine Wed afternoon around 4pm. Thursday morning around 9:30 I started with severe pain in my left leg. The pain worsened through the day and my leg began swelling. No other symptoms at all. This morning my leg was twice the size of my right leg so I went to the ER. I live in so I'm at ED. I have a massive blood clot running the the length of my leg - from my thigh to my ankle. I'm very lucky I got here so fast! I?m a very healthy 49 year old with no history of DVT or blood clots so they dug further to find out why. A cat scan showed I have a congenital condition called May Thurner Syndrome. I?m so relieved to have an answer and it?s fixable! The vascular doctors are not 100% convinced that?s not all that was going on as I was born with the syndrome and I?ve gone this long without a clot. So they are doing lots of labs to see if anything else shows up. This is where we are at. I?m being admitted to take care of the clot."
49 2021-01-20 lymph node swelling Migraine Swollen axilla lymph nodes Low grade fever 100 Chills
49 2021-01-20 peripheral swelling A lot of pain in arm; arm was completely swollen with hard ball underneath where the injection was g... Read more
A lot of pain in arm; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; This is a spontaneous report from a contactable other hcp (patient). A 49-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose bnt162b2 on 18Dec2020 for Covid-19 Immunization and experienced a lot of pain in arm which was normal. On 10Jan2021, the patient's arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy and on an unspecified date the patient had a lot of pain in arm. She had not taken anything other than acetaminophen (TYLENOL) 650 mg. The patient thought it was due to the vaccine (COVID-19 vaccine) she got the reaction. The outcome of the events was unknown.
49 2021-01-20 swelling I lifted my left arm that same evening of the injection and under my armpit I felt swelling. The nex... Read more
I lifted my left arm that same evening of the injection and under my armpit I felt swelling. The next day I called my PCP and they examined my left arm, under armpit but told my lymphnodes had no swelling. Within a few days, the swelling went down.
49 2021-01-21 lymph node swelling Was vaccinated in the evening of the 19th and symptoms started around 3pm the next day. All over bod... Read more
Was vaccinated in the evening of the 19th and symptoms started around 3pm the next day. All over body aches, severe right ankle/heel pain, headache, fever 101, chills, sweats. 1/22/2021 left axillary lymph node swelling and soreness.
49 2021-01-23 oral herpes fever of 103 degrees with chills, uncontrollable shaking, vomiting beginning around 8:00 PM, Tyleno... Read more
fever of 103 degrees with chills, uncontrollable shaking, vomiting beginning around 8:00 PM, Tylenol did not reduce fever, went to ER and was admitted post chest x-ray, CT scan, dopplers. While admitted was treated for adverse reaction and pneumonitis diagnosed in ER. Treatment included iv fluids, iv antibiotics (Rocephin), magnesia, potassium, anti-nausea mediation, breathing treatments, Lovenox injections, blood draws for labs multiple times per day.
49 2021-01-24 anaphylactic reaction anaphylaxis
49 2021-01-24 lymph node swelling Swollen lymph node/gland w/ tenderness in the left arm Pitt
49 2021-01-24 swelling face I had the first dose on Friday afternoon and on Monday morning when I woke up it feels like my face ... Read more
I had the first dose on Friday afternoon and on Monday morning when I woke up it feels like my face has been sunburned. It is red and slightly puffy. No new skin products or foods. No difficulty breathing or other symptoms. I am also a nurse practitioner.
49 2021-01-25 lymph node inflammation Fever, cellulitis on the 2nd dose administration arm, inflammation and nodes in axilla, dizziness.
49 2021-01-25 lymph node swelling First day-headache; second day feeling unwell; 3rd day tenderness; lymphadenopathy, right underarm.;... Read more
First day-headache; second day feeling unwell; 3rd day tenderness; lymphadenopathy, right underarm.; swollen lump nose; swollen lump nose; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular in right arm on 07Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included valley fever treatment for 4 months. No known allergies. Concomitant medication included fluconazole. On 07Jan2021 18:00, the patient experienced first day-headache, second day feeling unwell, and third day tenderness/ swollen lump nose, lymphadenopathy, right underarm. Patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Treatment received for the events included TYLENOL tabs. The outcome of the events was not recovered.
49 2021-01-25 swelling face, anaphylactic reaction ? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat... Read more
? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat, breathing difficulty, cough, aphasia-pt was not able to express her thoughts or needs, pt felt that her heart was beating slow, vomiting started next day and lasted for 4 days, self treatment immediately by pt- Benadryl 50 mg and albuterol inhaler, later Prednisone course by medical professional symptoms completely resolved after 5 days
49 2021-01-25 swelling 12/21/2021 HIVES AT THIGHS WITH ITCHING AT SITE ITCHING -RT SAME DAY 01/12/2021 HIVES AND ITCHING TO... Read more
12/21/2021 HIVES AT THIGHS WITH ITCHING AT SITE ITCHING -RT SAME DAY 01/12/2021 HIVES AND ITCHING TORSO AND THIGHS- SITE OF ARM- LT SAME DAY UP TO 4TH DAY-WORST OM 1/16/2021 WITH RESTLESS NIGHT WAKING UP EYE MATTED-WAKING UP ITCHYAT SITE/TORSO/THIGHS/LT EYE SWELLING AND RT EYE WITH WATERY LUNG FEELING SEEN AT THE ER AND ORAL STEROIDS CAUSE SOME SWELLING AT OTHER EYE BUT BETTER AFTER 30 MIN.AFTER A NAP RT EYE WAS SWELLING W/O ITCHING PRETTY BAD.AND ORAL MEDROL PACK LAST DOSE 1/19/2021 AND FORGOT THE DOSE ON 1/21/2021 AT WORK HAD EYE SWELLING LT EYE FIRST THEN WENT TOOK A DOSE THEN HAD ON THE RT EYE. SWELLING WITH TORSO AND SITE ITCHING TOO SO TOOK ANOTHER STEROID GETTING BETTER WITH PO BENADRYL 50 MG- FATIGUE BUT PRETTY GOOD.YESTERDAY TIRED TOWARDS THE END OF SHIFT AND THIS AM AFTER 9 HRS WAS FEELING TIRED-FATIGUE- STARTED LATE AND THIS PM SWELLING ON THE LT AND THEN RT (SAW CHIROPRACTOR 1/23/2020). IM DEXAMETHASONE 8 mg IM NOW BETTER AFTER 30 MINUTES BETTER.
49 2021-01-27 lymph node swelling Swollen axillary lymph node on same side as injection; fatigue; body aches; headache; injection site... Read more
Swollen axillary lymph node on same side as injection; fatigue; body aches; headache; injection site soreness; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), via an unspecified route of administration in left arm on 13Jan2021 00:15 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included asthma, anxiety and penicillin allergy. The patient did not have COVID prior to vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), zinc (ZINC), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), and montelukast sodium (SINGULAIR). The patient previously received the first dose of bnt162b2 (lot number EL1284) on 23Dec2020 12:00 PM in left arm for COVID-19 immunization. The patient experienced swollen axillary lymph node on same side as injection, fatigue, body aches, headache, injection site soreness on 13Jan2021 20:00. The outcome of the events was recovering. No treatment was received for the events. The patient was not tested for COVID-19 post vaccination.
49 2021-01-27 swelling face, peripheral swelling left upper arm swelling; neck pain, mainly on left side; Headache; left sided facial swelling; This ... Read more
left upper arm swelling; neck pain, mainly on left side; Headache; left sided facial swelling; This is a spontaneous report from a contactable nurse (patient herself). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1284, expiry date Apr2021), via an unspecified route of administration on 13Jan2021 at a single dose in the left arm for immunity (COVID-19 immunisation). There were no medical history and concomitant medications. The patient received the COVID vaccine and developed some symptoms on 13Jan2021. The symptoms were: left upper arm swelling, neck pain, mainly on left side, a headache, and left sided facial swelling. The patient had not recovered from the event headache. The outcome of the events left upper arm swelling, neck pain and left sided facial swelling was recovering. The events left upper arm swelling, neck pain, mainly on left side and relatedness left sided facial swelling with COVID vaccine was related.
49 2021-01-27 swelling face diffuse urticarial rash. facial swelling.
49 2021-01-27 swelling Pt was up and caregiver noticed she didn't look right. she stated to caregiver she felt like she was... Read more
Pt was up and caregiver noticed she didn't look right. she stated to caregiver she felt like she was having a reaction. pt was assisted to the floor. RN assessed pt and noticed her tonge swelling and patient getting red and neck swelling. RN ran to get emergency kit EPI PEN. EPI Pen administered Right thigh. EMS arrived. took patient to the ED for further treatment.
49 2021-01-28 swollen extremities Fullness under my armpit which is on the same side as the vaccine, which looks like swollen lymph no... Read more
Fullness under my armpit which is on the same side as the vaccine, which looks like swollen lymph nodes under my armpit/kind of benign; Generalized malaise low grade; Headache; Both eyes are very swollen; inflammatory prosthesis in my eye; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247) via an unspecified route of administration at arm on 15Jan2021 11:00 at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Nurse stated that she just wanted to report what she thinks is adverse reaction to the Covid-19 vaccine from Pfizer not sure what to do about it at this point. She was vaccinated Friday 11 o'clock in the afternoon. Both days felt really fine. Last night (16Jan2021) got some fullness under her armpit which was on the same side as the vaccine, which looked like swollen lymph nodes under her armpit which you can see was kind of benign. But in addition to that some generalized malaise lowgrade and headache (Jan2021). Seems totally fine but her both eyes are very swollen (Jan2021). Nurse took some ibuprofen (ADVIL)-600 mg, she was taking Prednisone for inflammatory prosthesis in her eye as treatment (Jan2021). Outcome of the events was unknown. The nurse considered the occurrence of the events are because of COVID-19 Vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Swollen eyes and Eye inflammation cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-01-28 peripheral swelling left arm is "double swollen"; broke out in hives; Have troubles trying to swallow; feels like "somet... Read more
left arm is "double swollen"; broke out in hives; Have troubles trying to swallow; feels like "something is cutting" through her throat; This is a spontaneous report from a non-contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the vaccine at 10:30 and then started experiencing "bad side effects" almost 10 hours later. She said her left arm is "double swollen", she broke out in hives, have troubles trying to swallow, and she feels like "something is cutting" through her throat. With this, she wanted to know what temperature should the vaccines be stored in since she noticed that the place where she got the vaccine was "kind of warm". The outcome of the events was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
49 2021-01-28 swelling pain/mildly achy; small SQ bump; red and swollen 2x3cm, firm; red and swollen 2x3cm, firm; red and s... Read more
pain/mildly achy; small SQ bump; red and swollen 2x3cm, firm; red and swollen 2x3cm, firm; red and swollen 2x3cm, firm; gray discoloration; muscle atrophy; Indentation; This is a spontaneous report from a contactable 49-year-old female physician reported for herself. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via an unspecified route of administration on 23Dec2020 07:30 at single dose at left arm for covid-19 immunisation. Medical history included allergy: walnuts. Concomitant medication within 2 weeks of vaccination included medroxyprogesterone acetate (DEPO PROVERA). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced initial pain and small SQ bump. After 1 week, red and swollen 2x3cm, firm. No pain, no warmth. About 2 weeks after, swelling gone, but gray discoloration on 2x3 cm area. Now after 3 weeks, same area with muscle atrophy. Indentation and mildly achy. Adverse event start date was reported as 30Dec2020. Patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included nasal swab, SARS-CoV2, NAAT: negative on 05Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive treatment for events. Outcome of event swelling was recovered, and outcome of other events was not recovered. The report is considered as non-serious.
49 2021-01-31 lymph node swelling swollen lymph node above left clavicle- no pain Denies any other symptoms- fever, chills, body ach... Read more
swollen lymph node above left clavicle- no pain Denies any other symptoms- fever, chills, body aches, headaches
49 2021-01-31 peripheral swelling, lymph node swelling Lymph Node swelling under right arm pit and arm. Pain the radiated from there down to fingertips.
49 2021-01-31 swelling face Systemic: Other- facial swelling- lips and eyes-Medium
49 2021-02-01 anaphylactic reaction, swelling face Lips swelling and face; Lips swelling and face; Anaphalaxis; Anaphalaxis; This is a spontaneous repo... Read more
Lips swelling and face; Lips swelling and face; Anaphalaxis; Anaphalaxis; This is a spontaneous report from a contactable other HCP (patient). A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Eh9899) via an unspecified route of administration on 18Dec2020 18:30 at single dose in left arm for COVID-19 immunisation. She received the second dose (lot number: El1283) in right arm on 08Jan2021. Medical history included Idiopathic anaphylaxis and was allergic to penicillin, had COVID-19 from May2020 to an unknown date. Concomitant medication included unspecified birth control pills. The patient experienced anaphalaxis on 19Dec2020 06:00 AM. She talked with her doctor lips swelling and face. Treatment received for events lips swelling and face. But her question is she had an IGG antibody test and it was negative. She had COVID in May2020 and have been tracking her antibodies. She wanted to know 'does this antibody test show the same antibodies?' She had negative after the two vaccines. The patient is not pregnant. Events outcome was recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-02-01 anaphylactic reaction a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny ... Read more
a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny nose; Cough; Anaphylaxis; This is a spontaneous report from a contactable consumer(patient). A 49-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), intramuscular in right bicep(arm) on 13Jan2021 around 16:15 at single dose for preventative. Medical history included high blood pressure from 2016 and ongoing. Concomitant medication included ongoing chlortalidone for high blood pressure. She received first dose of covid vaccine BNT162B2 (Lot: EL0140) on 23Dec2020 around 13:00., in right bicep(arm), a little above where she received this second dose for covid-19 immunization, she previously received flu shot for immunization and had a knot in her arm where it is tender to the touch and sore. She had an anaphylaxis event directly after her shot on 13Jan2021, she was kind of knocked out for the anaphylaxis event and her body was hurting. She was not sure if it was from the shot or from the trauma anaphylaxis event. She received an epi shot in the clinic, diphenhydramine (BENADRYL)into her arm. She was taken to the ER(Emergency Room) where she stayed till about 9:30pm. She was not admitted. Anaphylaxis recovered on 13Jan2021. She also stated that she got sick after the shot, she was exhibiting flu-like symptoms, she never lost her taste or smell, she had a fever, severe body aches, runny nose, and a cough. These symptoms started the next day on the 14Jan2021 and got worse on the 15Jan2021, on 17Jan2021, She feeling better morning and recovered completely by the time she went to bed in regards to her flu-like symptoms, she felt like herself and normal. She felt rested. This morning she felt good. Treatment included paracetamol (TYLENOL) and she was taking diphenhydramine every night since the anaphylaxis occurred. She still had a knot in her arm that it was very sore to the touch which she stated was pretty common even with flu shot(not know the name of the flu shot or have lot, NDC, or expiration date) where it was tender to the touch and sore. There was no relevant test. Outcome of anaphylaxis was recovered on 13Jan2021, of a knot in her arm, sore to the touch was unknown, of other events was recovered on 17Jan2021.
49 2021-02-03 anaphylactic reaction Systemic: Anaphylaxis-Severe, Systemic: Fainting-Severe, Systemic: Seizure-Severe
49 2021-02-03 lymph node pain Weakness; fatigue; small breathes like slightly short of breath; body aches/ severe tender and painf... Read more
Weakness; fatigue; small breathes like slightly short of breath; body aches/ severe tender and painful lymph nodes-to neck and groin and around sides; low grade fever; abdominal pain one day; all days lymph nodes pain /neck lymph node aches/ severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; tenderness, especially around the side rib cage and waist area; tenderness especially around the side rib cage and waist area/ severe tender and painful lymph nodes-to neck and groin and around sides; feeling really bad like i want to cry; slight headache; night sweats; rapid heart rate; increased blood pressure; severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; tenderness to flank area; difficult to turn in bed and lie on right side; Itchiness but no visible rash; first dose of bnt162b2 on 28Dec2020 and second dose on 12Jan2021; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration at the right arm on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included taking medication for focus (adult adhd?); perimenopausal. She also has known allergies: sulfa; shrimp, strawberry/raspberry flavored foods or candies. The patient was not pregnant at the time of vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for focus, perimenopausal. The patient previously received the first dose of bnt162b2 intramuscularly at the right arm on 28Dec2020 at 2:30 PM at the age of 49 years for COVID-19 immunization (Lot number: EL3249). On 15Jan2021, the patient experienced weakness, fatigue, small breathes like slightly short of breath/ short of breath, body aches, low grade fever, abdominal pain one day, all days lymph nodes pain and tenderness especially around the side rib cage and waist area, more on right side then left, neck lymph node aches, feeling really bad like the patient wanted to cry, slight headache, night sweats. Lymph node pain and tenderness is the worse along with body aches and weakness. Also, on 15Jan2021, patient experienced rapid heart rate, increased blood pressure, severe tender and painful lymph nodes-to neck and groin and around sides, under ribs and tenderness to flank area. Mainly right below right ribs and right waist, right flank painful and difficult to turn in bed and lie on right side. There were also Itchiness but no visible rash. According to the reporter the events started on 15Jan2021 at 1AM. The patient received the first dose of bnt162b2 on 28Dec2020 and second dose on 12Jan2021. The patient had nasal swab, rapid on18Jan2021 result was negative and nasal swab on 20Jan2021 result was negative. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering except for abdominal pain one day which recovered on 16Jan2021.
49 2021-02-03 lymph node swelling Fatigue, fevers, nausea, body aches, chills, sore throat, swollen lymph nodes. Symptoms started on 1... Read more
Fatigue, fevers, nausea, body aches, chills, sore throat, swollen lymph nodes. Symptoms started on 1/28/21 and are ongoing.
49 2021-02-03 lymph node swelling non-swollen cord like lymph nodes; burning sensation and joint pain in injection arm; burning sensat... Read more
non-swollen cord like lymph nodes; burning sensation and joint pain in injection arm; burning sensation and joint pain in injection arm; 19Dec2020 she received the 1st dose. 2nd dose received 11Jan2021; This is a spontaneous report from a non-contactable consumer. A 49-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not provided), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose on 19Dec2020 and experienced numbness for an hour, and subsequently burning sensation and joint pain which subsided with Tylenol use. Patient's 2nd dose was received on 11Jan2021 and since 15Jan2021 she mentioned non-swollen cord like lymph nodes, burning sensation and joint pain in injection arm which transcends to the left arm. Tylenol helps sometimes. Outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
49 2021-02-03 lymph node swelling 103.0 fever; Severe swelling of nodes in left armpit; severe muscle, joint, skin aches; severe muscl... Read more
103.0 fever; Severe swelling of nodes in left armpit; severe muscle, joint, skin aches; severe muscle, joint, skin aches; severe muscle, joint, skin aches; headache; lethargy; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), intramuscularly in the right arm, on 08Jan2021 at 10:30 (at the age of 49-years-old) at a single dose for COVID-19 immunization. Medical history included interstitial cystitis, anxiety, and shellfish allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included mirabegron (MYRBETRIQ), escitalopram (MANUFACTURER UNKNOWN), doxycycline (MANUFACTURER UNKNOWN), bisoprolol (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), nortriptyline (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN), and colecalciferol (VIT D3). Other concomitant medications included an unspecified multivitamin. The patient previously took iodine (MANUFACTURER UNKNOWN) and experienced allergy. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ1685), intramuscularly in the left arm, in Dec2020 at 13:30 (at the age of 49-years-old) for COVID-19 immunization. The patient experienced 103.0 fever, severe swelling of nodes in left armpit, severe muscle, joint, skin aches, headache, and lethargy on 08Jan2021 22:45. The events were reported as non-serious. It was reported that the severe swelling of nodes in left armpit lasted less than 3 days. The patient underwent lab tests and procedures which included body temperature: 103.0 on 08Jan2021. The patient did not receive any treatment for the events. The clinical outcome of 103.0 fever, severe swelling of nodes in left armpit, severe muscle, joint, skin aches, headache, and lethargy was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
49 2021-02-03 lymph node swelling She had chills at 5pm, by 8pm she had heart palpitations, beat red face, nausea and swollen glands i... Read more
She had chills at 5pm, by 8pm she had heart palpitations, beat red face, nausea and swollen glands in throat. She then went to bed. She woke up around 10pm and felt fatigued but better.
49 2021-02-03 swollen extremities Elevation of Blood pressures proceeded with high 155/95; heart flutter; extreme breast tenderness; a... Read more
Elevation of Blood pressures proceeded with high 155/95; heart flutter; extreme breast tenderness; axillary swelling; felt general unwell feeling; This is a spontaneous report from a contactable healthcare professional reporting for self. This 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EL0140) via intramuscular on 18Dec2020 12:00 PM at right arm at single dose for COVID-19 immunization. Medical history included known allergies: cinnamon. Patient did not have COVID prior vaccination. Concomitant medications included cyanocobalamin (B12), zinc, 4-(4-hydroxyphenyl)butan-2-one, crocus sativus, magnesium oxide (BELL DE NUIT PRECIOUS MAGICAL). It was reported that first day approx 6 hours after injection patient felt general unwell feeling, next day (19Dec2020) extreme breast tenderness and initiation of axillary swelling. At day 10 post injection (28Dec2020) she experienced some type of heart flutter. Elevation of Blood pressures proceeded with high 155/95 on unspecified date. PCP visit with normal EKG and blood work following week. BP in office 135/85 (from memory). Patient did not receive second dosage at day 21 and BP has currently returned to normal this a.m. (20Jan2021) 117/68. There was no treatment received for events. Patient did not test COVID post vaccination. The outcome of events was recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
49 2021-02-03 peripheral swelling Received Pfizer vaccine on 2/2/2021, noticed that left hand was achy and swollen on 2/3/2021 and on ... Read more
Received Pfizer vaccine on 2/2/2021, noticed that left hand was achy and swollen on 2/3/2021 and on 2/4/2021, she noticed that her right hand was swollen.
49 2021-02-04 lymph node swelling swollen lymph nodes under left injection arm
49 2021-02-05 c-reactive protein increased pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22. pt prese... Read more
pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22. pt presented to my office on 1/25/21 she had confusion, memory loss, labial bp, relative hypotension, bradycardia, severe fatigue, muscle pain and weakness, barely able to rise from a chair or walk, also reported HA, diarrhea, hiccups,decreased O2 sat to a low of 91%-her baseline is 98-100%, she developed a rash after her appointment with me.
49 2021-02-05 lymph node swelling Bilateral large (3cm) axillary LAD, persisting for > 6 weeks epitrochlear adenopathy L arm Intercost... Read more
Bilateral large (3cm) axillary LAD, persisting for > 6 weeks epitrochlear adenopathy L arm Intercostal adenopathy R chest
49 2021-02-08 lymph node swelling headache, increased salivation, swollen mandibular gland, pain in neck radiating to ear
49 2021-02-09 white blood cell count increased Headache, fatigue, tingling in hands, pain and spasms in hands, pain in left leg.
49 2021-02-10 lymph node pain, lymph node swelling pt stated she had a headache the day of the vax but the day after she woke up with pain in the armpi... Read more
pt stated she had a headache the day of the vax but the day after she woke up with pain in the armpit. She said the lymph nodes are tender to touch and swollen under her right arm pit. She contacted her PCP and she was told to watch it for a couple of days and if wasnt better to give him a CB.
49 2021-02-10 lymph node swelling Started with brain fog, unable to focus, fatigue, chills and body aches. Continued to progress to t... Read more
Started with brain fog, unable to focus, fatigue, chills and body aches. Continued to progress to temp 101.8, shaking chills, EXTREME arm pain, upper back pain, chest pain, wheezing, SEVERE headache, nausea, vomiting, diarrhea, EXTREMELY swollen axillary lymph nodes enlargement. Symptoms started approx 2 hours after injection and proceeded for 6 days then started to slowly improved then resolve.
49 2021-02-13 lymph node pain, lymph node swelling Fever of 101 started mid day on 2/9/21 with aches and pains all over, especially in bilateral armpi... Read more
Fever of 101 started mid day on 2/9/21 with aches and pains all over, especially in bilateral armpits and headache . I took Tylenol and Ibuprofen every 6 hours alternating every 3 hours for coverage. When I woke up Wednesday 2/10/21 morning my left armpit lymph nodes were swollen and very painful. I still had fever and all other aches and pain.. Fever broke around 5pm on Wednesday.
49 2021-02-16 anaphylactic reaction Hives and it progressed to an anaphylactic reaction; Hives and it progressed to an anaphylactic reac... Read more
Hives and it progressed to an anaphylactic reaction; Hives and it progressed to an anaphylactic reaction; hives itch; slight swelling around her eyes; This is a spontaneous report from a contactable nurse (patient) via Pfizer Sales Representative. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 at single dose for COVID-19 immunization. Medical history included anaphylaxis (Patient does have a history of anaphylaxis to bee stings), Hysterectomy, Gallbladder surgery, Mastectomy partial/ lumpectomy, Alcohol use: Yes (Comment: socially rare, Drug use: Never), Shellfish-derived products, Seasonal allergies (J30.21), HX: breast cancer (Z85.31), smoker stopped on 01Jan2000 (Former Smoker, Years since quitting: 21, Smokeless tobacco: Never Used), Hot flashes, Axillary Node Dissection. Allergie to Bee venom, Shellfish-derived products, Coconut, Codeine, and Other The patient's allergies have been reviewed. Family History included Cancer oral of Mother; Lung cancer of Father and Maternal Grandfather and Paternal Grandmother; Uterine cancer of Paternal Grandmother. Concomitant medication included ongoing cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ongoing dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]), epinephrine (EPIPEN), ongoing lisinopril dihydrate (PRINIVIL), lisinopril (ZESTRIL), ongoing metoprolol succinate (TOPROL XL), valaciclovir hydrochloride (VALTREX), zolpidem tartrate (AMBIEN) from 30Apr2020 and ongoing, promethazine (PHENERGAN [PROMETHAZINE]) from 13Sep2019. Patient previously took Codeine and had vomiting and allergy to it. Patient had an anaphylactic reaction to our vaccine. it started as hives and it progressed to an anaphylactic reaction on 08Jan2021. they gave patient Benadryl afterwards for her anaphylactic reaction because they do not want to interfere with the efficacy of the vaccine that she was able to breathe so she did not have to have any Epipen or anything. She was sent to an ER within hospital to get that. She was in the hospital getting the shot and then they sent her to the ER and she started having the reaction. Emergency department summary of care: Chief complaint: Allergic reaction. ED Diagnosis: Diagnosis Final diagnosis. Allergic reaction to vaccine: Allergic reaction to vaccine. ED Vitals: Date/Time: 08Jan2021 14:00. Pulse: 79. Resp.: 18. BP: 144/86. SpO2: 96%. Date/Time: 08Jan2021 12:54. Pulse: 90. Resp.: 16. BP: 147/98. SpO2: 96%. Weight: 72. 06 kg (160 lb). Date/Time: 08Jan2021. Temp.: 97.6 F (36.4 C). Pulse: 121. Resp.: 16. SpO2: 97%. Result: None. Imaging result: None. ECG result: None. Emergency Department Encounter: Patient was placed in face mask in first look and the following protective measures were taken unless additional measures were taken and documented below in the ED course. Patient was wearing facemask when nurse entered the room and throughout our encounter. nurse wore full protective equipment throughout this patient encounter including a face mask, and gloves. Hand hygiene was performed before donning protective equipment and after removal when leaving the room. Date of encounter: 08Jan2021. Last ED provide Note: patient is a 49 y.o. female who presents to the ED c/o chief complaint of allergic reaction. Patient reports that she just received her first Covid immunization approximately 30 minutes ago, immediately broke out into hives. Patient reports she had hives on bilateral arms as well as her back, hives itch. Patient complains of slight swelling around her eyes. No swelling of her tongue slipped or throat, no difficulty swallowing, no difficulty breathing, no nausea or vomiting. Patient reports that prior to the vaccination she was at baseline without complaint. Patient does have a history of anaphylaxis to bee stings, no other history of anaphylactic reactions, does have history of allergic reactions with hives. Patient received 50 mg oral Benadryl prior to arrival. Patient reports that the hives on her arm have since resolved, continues complain of itching on her back. No active ambulatory problem. No resolved ambulatory problem. All systems reviewed and negative except for those discussed in HPI. PHYSICAL EXAM nurse have reviewed the triage vital signs and nursing notes. ED Triage Vitals (08Jan2021 1229): Temp: 97.6 F (36.4 C), Heart Rate: 121, Resp.: 16, SpO2: 97%. General: No acute distress. HENT: NCAT, PERRL, Nares patent, no swelling of the lips tongue, no posterior oropharyngeal swelling, Voice is normal, no difficulty handling secretions Eyes: no scleral icterus. Neck: trachea midline, no ROM limitations, no stridor. CV: regular rhythm, regular rate. Respiratory: normal effort, CTAB, no wheezing rales or rhonchi Abdomen: soft, nondistended, nontender to palpation, no rebound tenderness, no guarding or rigidity. GU: deferred. Musculoskeletal; no deformity. Neuro: alert, moves all extremities, follows commands. Skin: warm, dry, bilateral arms are normal in appearance, no hives, No rash. Patient has several scattered Hives on her back. Lab Results: No results found for this or any previous visit (from the past 24 hour(s)). Nurse ordered the above labs and reviewed the results. Radiology: No Radiology Exams Resulted Within Past 24 Hours. Nurse ordered the above noted radiological studies. Nurse reviewed the images and results. Nurse agree with the radiologist interpretation. Procedures: Medications - No data to display. PROGRESS DATA. A complete history and physical exam have been performed. All available laboratory and imaging results have been reviewed by nurseself prior to disposition. After the initial H&P, Nurse discussed pertinent information from history and physical exam with patient/family. Discussed differential diagnosis. Discussed plan for ED evaluation/work up treatment. All questions answered. Patient/family is agreeable with plan. ED Course: Patient complaining of allergic reaction, hives seems to be resolving, no symptoms consistent with anaphylaxis. Symptoms seem to be improving after oral Benadryl, no further medication at this time, will monitor closely. Patient reassessed, reports rash has resolved, itchiness has resolved. Patient continues to deny any swelling of lips tongue or throat, no difficulty breathing, no nausea or vomiting. Discussed at length with the patient that Nurse do not advise her to get the second dose of the vaccination as it can cause repeat allergic reaction, possibly worse allergic reaction. Discussed possibility of obtaining the mother no vaccine once it becomes available. Patient understands. Discussed need for close follow- up with primary care physician, Extensive discussion return precautions. Discharging. The patient was reexamined. They have had symptomatic improvement during their ED stay. nurse discussed today's findings with the patient, explaining the pertinent positives and negatives from today's visit, and the plan of used plan for discharge as there is care. No emergent indication for admission. Discussed limitation of the ED work-up and that this is to rule out life-threatening emergencies but that they could require further testing as determined by their primary care and or any referred specialist patient is agreeable and understands need for follow-up and repeat exam/testing. Patient is aware that discharge does not mean there is nothing wrong. Indicates no emergency is present, and that they must continue their care with their primary care physician and/or any referred specialist. They were given appropriate follow-up with their primary care physician and/or specialist. nurse had an extensive discussion on the expected clinical course and return precautions. Patient understands to return to the emergency department for continuation, worsening, or new symptoms. Nurse answered any of the patient's questions. Patient was discharged home in a stable condition. As of 14:11 EST Vitals: BP - 144/86, HR -79, Temp - 97.6 OF (36.4 (Tympanic) 02 SATS - 96%. DISPOSITION: DISCHARGE: Patient discharged in stable condition. Reviewed implications of results, diagnosis, meds, responsibility to follow up, warning signs and symptoms of possible worsening, potential complications and reasons to return to ER. Patient/Family voiced understanding of above instructions. Discussed plan for discharge, as there is no emergent indication for admission. Patient referred to primary care provider for BP management due to today' BP. Pt/family is agreeable and understands need for follow up and repeat testing. Pt is aware that discharge does not mean that nothing is wrong but it indicates no emergency is present that requires admission and they must continue care with follow-up as given below or physician of their choice. Schedule an appointment as soon as possible for a visit in 2 days. Medication List NO changes were made to your prescriptions during this visit. ED Treatment Team. Previous ED Visit: None. ED Arrival Information: Arrival: 08Jan2021 12:27 PM. Means of Arrival: Car. Escorted By: Self. Service: Emergency Medicine Acuity: Emergent. Admission Type: Emergency. ED deposition: Discharged: condition stable. Triage sepsis screen: Row name: Sepsis screen. Documented or Suspected Infection: 0. Documented or Suspected Infection. Indications: None. Acutely Altered Mental Status:0. Temp <96.8 OR > 100.9: 0. Heart Rate >90): 0. Respiratory Rate > 20: SBP < 90:0 MAP < 65:0 Blood Glucose >140(mg/dL)- Not diabetic: WBC <4 or>12 (10*3/mmm3: Unknown Bands >10%. Result of current screen is: Negative. Medication administration from 08Jan2021 12:27 to 09Jan2021 02:02: None. ED Prescription: None. Discharge Orders (From admission, onward): None. Allergies (Reviewed on: 08Jan2021) Agent Bee Venom Severity: High, Shellfish-derived Products, Severity: High Comments: Anaphylaxis. Coconut Comments: Facial swelling. Codeine Comments: Vomiting. Other Severity: Phenofibrates cause Skin hives. Immunizations Administered Name: COVID-19 (PFIZER) Tetanus Up TO Date: None. ED LDA Documentation (to) Patient Lines/Drains/Airways Status Active Airway / Central Venous Catheter Line / Drain / Epidural Line / Intraosseous Line / Peripherally Inserted Central Catheter Line / Peripheral Intravenous Line / Arterial Line: None. Weight: 72.6 kg (160 1b). Height: 157.5 cm (62"). Oxygen Therapy from 07Jan2021 14:02 to 08Jan2021 14:02. Oxygen Therapy from 07Jan2021 14:02 to 08Jan2021 14:02 (continued) Date and Time 08Jan2021 14:00 (also reported 14: 11) sp02: 96 %. Date and Time 08Jan2021 12:58 Device (Oxygen Therapy: Room air. Date and Time: 08Jan2021 12:54 sp02: 96 % Device (Oxygen Therapy: Room air. Date and Time 08Jan2021 12:29 sp02: 97%. Breathing Date and Time: 08Jan2021 14:00, Date and Time: 08Jan2021, 12:54 Date and Time: 08Jan2021 12:29 were sp02:96 %, sp02:96 % and sp02:99 %. 08Jan2021 14:00 Departure Condition: Stable, Mobility at Departure: Ambulatory Patient Teaching Discharge instructions reviewed; Follow-up care reviewed; Medications discussed; Patient verbalized understanding. ED Events: Date/Time 08Jan2021 12:27 Patient arrival, Arrival info file, 08Jan2021 12:29 Triage Started, Patient roomed in ED, 08Jan2021 12:32 Assign Attending, Assign Provider, First Provider, Evaluation of Patient, 08Jan2021 12:52 Registration Completed 08Jan2021 12:56 Triage Completed, 08Jan2021 14:02 Patient discharged, ED Tracking End. Follow-up Information: Details Schedule an appointrnent as soon as possible for a visit in 2 days. Specialty: Family medicine Discharge Instructions: You have been given emergency department evaluation. This evaluation is intended to rule out life-threatening conditions. Is not a complete evaluation. You could require further testing as determined by your primary care physician or any referred specialist. Please follow-up with all doctors that you are referred to. Please be sure to take your prescribed medications and follow any specific instructions in the discharge instructions. Please follow-up with your primary care physician within 48 hours. Please have your primary care provider recheck your blood pressure. Please return to the emergency department if you experience chest pain, shortness of breath. abdominal pain, fever greater than 102, intractable vomiting. Please return to the emergency department if your symptoms continue or worsen, or if you begin to experience any other concerning symptom.Discharge References/Attachments: Hives Easy-to-Read AVS Reports: Date/Time: 08Jan2021: Report: COVID-19: Overview & Impact. Date/Time: 08Jan2021 Report: ED after Visit Summary. Chart Review Routing History No routing history on file. Case Management registry, Status: Active, First included on: 08Jan2021 2:20 PM, Emergency Encounter Documentation Registry, Status: Active, First included on: 09Jan2021 12:06 AM, Emergency Encounters Registry Status: Active, First included on: 08Jan2021 12:36 PM. Patient was recovering from the events. Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of Anaphylactic reaction, hives, itching and Eye swelling cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-02-16 peripheral swelling About 3am the next morning I woke up to a loud ringing in both my ear. When I sat up I was very ver... Read more
About 3am the next morning I woke up to a loud ringing in both my ear. When I sat up I was very very dizzy. I got up and showered and my feet swelled very bad. I did not feel well but I went to work but the feelings never got better. So on 1/10 Sunday I went to the medical center because I jjust didnt not feel well. The swelling in the lower legs was still there so I was prescribed 20 mg of presnisone for 5 days. The sound changed during the time of the antibotics but after I stopped taking the prednisone the ringing sound came back, my left foot is still numb and my eyes are constantly red and burning even after putting drops in my eyes, I still suffer from headaches and if I turn my head too far left or right I get dizzy still to date. On 1/14 I was given a 60 mg dose of tapered predinosone for 2 week to help elevate the symptoms but it did not work. On 2/12 I saw an ENT specialist who performed a hearing test which did produce minor hearing loss and was diagnosed with having Tinnitis.
49 2021-02-17 swollen extremities Severe extremity edema, hives with pruritus. Mild shortness of breath. None of these events occurre... Read more
Severe extremity edema, hives with pruritus. Mild shortness of breath. None of these events occurred with first dose. Have taken Benadryl 25mg every 6 hours. Still persistant.
49 2021-02-19 lymph node swelling Pain and swelling in armpit. Jaw pain on left side. Bad headache
49 2021-02-20 swelling face ON DAY 2 AFTER VACCINE WOKE UP WTIH PERIORBITAL EDEMA AND FACIAL SWELLING. DID NOT GO DOWN UNTIL DAY... Read more
ON DAY 2 AFTER VACCINE WOKE UP WTIH PERIORBITAL EDEMA AND FACIAL SWELLING. DID NOT GO DOWN UNTIL DAY 4 AFTER VACCINE. TOOK ALLEGRA D ALL 4 DAYS TO HELP WITH INFLAMMATION.
49 2021-02-20 swelling Swollen and itchy red bump that feels warm and hard like a mosquito bite
49 2021-02-22 anaphylactic reaction, swelling face hives; facial swelling; throat swelling; throat itching; nausea; anaphylactic reaction/ Anaphylaxis;... Read more
hives; facial swelling; throat swelling; throat itching; nausea; anaphylactic reaction/ Anaphylaxis; This is a spontaneous report from a contactable physician via FDA. A 49-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in the arm on 17Dec2020 at 13:30 at 0.3 ml, single dose for covid-19 immunization. Medical history included ongoing essential hypertension, ongoing protein c deficiency, ongoing lumbosacral radiculopathy, ongoing type 2 diabetes mellitus, ongoing pulmonary embolism, Strep pharyngitis from 29Nov2020 and resolved at the time of vaccination, serious allergic reaction, allergy to iodonated contrast media and Cardiac Arrest after IV contrast. Concomitant medication included apixaban (unknown manufacturer) for Protein C Deficiency, metformin hydrochloride (unknown manufacturer) for Type 2 Diabetes, chlorthalidone (unknown manufacturer) for hypertension, metoprolol (unknown manufacturer), clonidine hydrochloride (unknown manufacturer) for hypertension, atorvastatin (unknown manufacturer), magnesium oxide heavy;tocopheryl acetate (unknown manufacturer), tramadol hydrochloride (unknown manufacturer), diphenhydramine hcl (unknown manufacturer), epinephrine bitartrate (unknown manufacturer) for serious allergic reaction and anaphylaxis. On 17Dec2020 at 13:48, approximately 13min after vaccination while in observation the patient experienced hives, facial swelling, throat swelling/itching, and nausea. Patient was immediately taken to Emergency Department where epinephrine was given 1M in the left thigh followed by 125mg IV solumedrol, 50mg IV benadryl, 1000mL NS, and 20mg IV famotidine. Hemodynamically stable throughout ED course. The events were considered serious as per hospitalization. Medical Tests and Laboratory results related to the adverse event included: CRP: 11.0, Glucose-182, BRN-29, INR-1.1, Remained of CMP and CBC were WNL. The physician stated that anaphylactic reaction onset 6min after vaccination symptoms improved - 20min after epipen administration, Resolved 60 min later. The signs and symptoms of anaphylactic reaction included Diffuse rash, Itching, throat/lip swelling, shortness of breath, cough, BP 128/72, Spon-97% HR-71. The patient rushed to ED from vaccination PoD. Received EpiPen approximately 8 min post vaccination. Then received steroid, antihistamines, IVF. Sx improved in 20 min resolved 60 min. The patient was not hospitalized and not admitted to an intensive care unit for anaphylactic reaction. The physician stated that multiorgan involvement included respiratory, dermatological/mucosal. Also reported as Respiratory: Yes; Upper airway swelling: Yes; Respiratory distress: Yes; Tachypnoea: Yes; Dry cough: Yes; Difficulty breathing (without wheeze or stridor):Yes; Dermatological/Mucosal: Yes; Generalized urticarial: Yes; Angioedema (not hereditary): Yes; Generalized pruritus with skin rash: Yes. The following laboratory tests or diagnostic studies performed included Hematology on 17Dec2020 showed: results with units, if applicable: 8/13/299/41; Clinical chemistry on 17Dec2020 showed: results with units, if applicable: 137,103,29/36,22,07 (Less than sign) 182; CRP on 17Dec2020 showed: results with units, if applicable: 11.0. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient had not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient had anaphylaxis on 17Dec2020 at 13:36. The patient was not deceased and received treatment. Treated in emergency room/ epinephrine IM IV steroids, antihistamines, IV fluids. The physician considered the Pfizer product had a causal effect to the adverse event. The outcome of the event anaphylactic reaction/ anaphylaxis was recovered on 17Dec2020, while other events were recovered on 17Dec2020 at 13:48. Information on the lot/batch number has been requested. Follow-up (08Feb2021): New information received from the contactable Physician included: additional medical history and lab data, concomitant medications details, suspect drug information (lot number, dosage regimen details), event information (new event "anaphylactic reaction/ Anaphylaxis") and other clinical courses.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events anaphylactic reaction/Anaphylaxis urticaria, swelling face, pharyngeal swelling, throat irritation and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-02-22 lymph node swelling Fever Headache Body Aches Diarhea Swollen Lymphnodes Terrible Shoulder/Arm pain Attacked Lymphatic S... Read more
Fever Headache Body Aches Diarhea Swollen Lymphnodes Terrible Shoulder/Arm pain Attacked Lymphatic System
49 2021-02-22 lymph node swelling Swollen lymph nodes in arm pit of left arm.
49 2021-02-22 swelling small nodule, painful sweeling on shoulder blade area
49 2021-02-23 lymph node swelling Pfizer-BioNTech COVID-19 Vaccine I received my injection on 2/6/21. On 2/9/21 or 2/10/21, I began t... Read more
Pfizer-BioNTech COVID-19 Vaccine I received my injection on 2/6/21. On 2/9/21 or 2/10/21, I began to feel swollen nodes under my left arm (injection arm) and developed a mild rash on my left arm. The rash worsened and spread to my torso, right arm, and both legs. I saw a teledoc on 2/16/21 who told me to take benedryl every 6 hours and pre-treat prior to getting the second shot. I took benedryl for two days, but then switched to Allegra, to reduce fatigue. Rash did not improve. I saw an urgent care provider on 2/23/21 who prescribed antihistimine, anti-itch med, and steroid pac.
49 2021-02-24 lymph node swelling Lymphadenopathy, neck tenderness + stiffness, even painful in places.
49 2021-02-24 peripheral swelling Pain and swelling in. arm Fever, low-grade Chills Achiness Fatigue Headache
49 2021-02-25 lymph node swelling Over a week ago I started feeling a tightness in my right cheek and neck. I wasn't sure what it was ... Read more
Over a week ago I started feeling a tightness in my right cheek and neck. I wasn't sure what it was but it went away. I received my second vaccination 3 days ago and the tightness is back. Accompanied by sore throat. I felt the area and the lymph node in front of my right ear and the one in my neck on ther right side are swollen. :
49 2021-02-26 peripheral swelling Fever and body aches for one day the day after. Then 2/26 got large swollen area in underarm of arm... Read more
Fever and body aches for one day the day after. Then 2/26 got large swollen area in underarm of arm where got shot and it is extremely painful.
49 2021-02-27 swelling face 5 min after the shot, throat and chest began to feel slightly tight; nurse monitored for 45 min; no ... Read more
5 min after the shot, throat and chest began to feel slightly tight; nurse monitored for 45 min; no other symptom changes or treatments given; 65 hours later woke up with a swollen face and generalized rash on throat - this is current state at time of submission so final outcome unknown at this time
49 2021-02-28 peripheral swelling patient had swelling of arm and fainted. patient was provided a cold pack for their arm and head/nec... Read more
patient had swelling of arm and fainted. patient was provided a cold pack for their arm and head/neck. symptoms resolved
49 2021-02-28 swelling Fever 103.0 F, Chills, Muscle Pain, Headache, Night Sweats, Dizziness/near-syncope, tachycardia (120... Read more
Fever 103.0 F, Chills, Muscle Pain, Headache, Night Sweats, Dizziness/near-syncope, tachycardia (120's bpm), nausea, severe fatigue, severe soreness at injection site (but mild swelling, mild itching). Starting from 3:30 am on 02/21/21 until about 3 pm on 02/22/21. Milder headache and fatigue throughout rest of that week. Back to normal now.
49 2021-03-02 lymph node swelling received Pfizer vaccine through on 2/19/2021. Pt woke on 2/26/2021 with a bad headache on left side... Read more
received Pfizer vaccine through on 2/19/2021. Pt woke on 2/26/2021 with a bad headache on left side of her head, left side of her neck was sore & there was a lump on her left clavicle. She went to her PCP's walk-in clinic on 2/26/2021. Diagnosed with a bright red left ear, swollen lymph nodes on the left side of her neck, clavicle & left arm pit. She was prescribed Amoxicillin for 10 days.
49 2021-03-02 swelling Fever, headache, extreme swelling in shoulder/collarbone area
49 2021-03-04 swelling face Patient received first dose of Pfizer COVID 19 vaccine at 0845. Patient mentioned history of mast c... Read more
Patient received first dose of Pfizer COVID 19 vaccine at 0845. Patient mentioned history of mast cell activation syndrome as well as history of several anaphylactic events to the vaccinator. Patient related that she had her personal Epi-pen with her on site. Vaccinator elected to have patient wait recommended 30 minutes. At 15 minutes post vaccination, patient stated that she was experiencing the sensation of throat and facial swelling, elaborating that this is typical for her anaphylactic reactions. Patient was addressed by the PA-C on site. Upon exam, some edema of the brow bones were noted. No edema noted in the oropharynx. Dermatographia noted on the patient's tattoos, however, no generalized rash or injection site reaction noted. Heart rate and rhythm regular. Pulse 60bpm, strong. BP 118/72. Bilateral lungs clear to auscultation in all fields. No wheezing or stridor noted. Patient denied presence of cramping abdominal pains, nausea, and vomiting. Patient was provided with 10mg Claritin ODT and 25mg PO Benadryl. Patient related that she had famotidine at home that she normally takes when such events occur. At 30 minutes post po meds, Patient related she felt better and did not feel the need to be transported by EMS, though it was offered. Discussed at length with patient regarding follow up care and low initiation threshold for emergency response.
49 2021-03-07 lymph node swelling About one too two weeks post second shot, I started developing soreness under my arms. I had initial... Read more
About one too two weeks post second shot, I started developing soreness under my arms. I had initially thought that is was possibly pre menopausal. then a week or so later I developed lumps in my armpits. I thought this was from my deodorant. A few days ago I was told that this has been a post vaccine symptom.
49 2021-03-07 swelling face Adverse reaction began 20 minutes of receiving injection. Began with a rash on throat and neck. Foll... Read more
Adverse reaction began 20 minutes of receiving injection. Began with a rash on throat and neck. Followed by swelling of throat, trouble breathing, O2 levels dropped, itching began, selling in face, watery eyes, and other.
49 2021-03-08 lymph node pain, lymph node swelling Extreme pain swelling lymph nodes
49 2021-03-09 lymph node pain Within about 20 hours I spiked a fever of 102.7 and 102.9 for two days and then my temperature dropp... Read more
Within about 20 hours I spiked a fever of 102.7 and 102.9 for two days and then my temperature dropped to 99.6 for a day. I had chills, joint achiness, fatigue, foggy headed feeling, a runny nose, sinus pressure, headache, chest tightness and pain, arm pain, stomach pain, lymph nodes in my left armpit are sore (after 10 days), and I now seem to have a worsened allergy to dairy and a new allergy to nuts - I get very phlegmy, cough, and have chest pain and tightness. These symptoms lasted for 5- 6 days and the allergies with their symptoms and sinus pain and sore lymph nodes have continued.
49 2021-03-09 swelling 24 hours after vaccination patient complains of arthralgias, fatigue, headache. 36 hours after vacc... Read more
24 hours after vaccination patient complains of arthralgias, fatigue, headache. 36 hours after vaccination complained of macular rash on the left breast above the areola. Seen in clinic on March 10, macular confluent erythema 9 x 5 cm, no induration, no pruritis, mild swelling, c/ pain in left axillary area. No nipple discharge. Afebrile. No adenopathy. BP 121/78, pulse 72, Resp. 17, T 36.1 C, Sat 91%. z
49 2021-03-12 swollen extremities 1628 ? Patient received first dose of Pfizer vaccine. She reported a history of allergic reactions ... Read more
1628 ? Patient received first dose of Pfizer vaccine. She reported a history of allergic reactions in the past and was thus observed for 30 minutes following her injection time. 1704 ? Vitals: 99% sp02, 192/101 BP. Patient reported symptoms of itching of face, scalp, eyes, and hands. 25 mg Benadryl given by Observer. Patient placed on continuous sp02 monitor. No SOB, cough, or wheezing at this time. 1710 ? Observers called ED Nurse to let them know we would likely be sending a patient their way. 1715 - Observer was advising patient?s husband to take her to the ED when Coordinators were alerted to situation. contacting ED and allowing patient to transport themselves is not our protocol and Coordinators took control of the situation at this time. 1717 ? 1720 ? Patient moved by wheelchair to private area in the library for further evaluation. Vitals: 99% sp02, 200/119, BP, 90 HR. assessed patient. Rash but not hives are present on her chest. There is mild end-expiratory wheezing consistent with asthma history. No airway edema. No trouble speaking or swallowing. She is mildly diaphoretic but neurologically intact. 1720 ? Rapid response called for transport to ED. Sp02 98 ? 99. 1722 - Patient is starting to have increased wheezing with sp02 holding at 98%. She doesn?t have her inhaler. 1727 ? Rapid response called to say transport is 5 ? 10 minutes away. Patient still on monitor. No visible airway edema. Starting to cough and bilateral upper extremities mildly edematous. She notes her back is itching in addition to chest. 1728 ? After briefly explaining procedure to patient and obtaining verbal consent, 0.3 mg Epi Pen injection given to right lateral thigh. Vitals 192/133 BP, 91 HR, 99% 02. 1731 ? EMS arrives. Itching, wheezing, and cough have improved. Report given to EMS. Patient transported by stretcher to ED. Report had previously been given to ED and updates since then were given to EMS.
49 2021-03-12 peripheral swelling Bilateral swelling of big toe, 2nd toe, and 3rd toe on left/right feet. began with swelling. blist... Read more
Bilateral swelling of big toe, 2nd toe, and 3rd toe on left/right feet. began with swelling. blisters, then developed. inflammation, heat, and pain also present. became difficult and painful to wear socks. shoes were also uncomfortable. swelling and sensitivity were present all day, but flare ups occured in evening which included further swelling, pain, redness, and tingling sensation. PCP diagnosed anti-fungal and said would improve. after 7 days on anti-fungal ointment, no improvement. Referred to dermatologist. Dermatologist diagnosed Pernio/Chilblain, likely related to 2nd Vaccine. prescribed topical steriod and suggested keeping toes and feet warm at all times.
49 2021-03-12 peripheral swelling At around 1:30 I started feeling achy and tired. Overnight and the following day, I couldn't get out... Read more
At around 1:30 I started feeling achy and tired. Overnight and the following day, I couldn't get out of bed. I had an increase in hot flashes, which lasted through the 2nd day and I was back at work. On the 2nd day, the arm pain and swelling worsened. I had a 2 in x 2 in area of redness by the injection site. With the 1st one I had a lot of hot flashes, but nothing to where I was unable to work.
49 2021-03-13 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: C... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium
49 2021-03-13 swelling, lymph node swelling Found right side lymph swelling starting in the right side armpit and running down to a large golf ... Read more
Found right side lymph swelling starting in the right side armpit and running down to a large golf ball sized lump in the right side breast, between the bottom border of the nipple and the chest wall. PMD was seen the next day, we were advised to monitor the swelling and to return if symptoms became worse. The next vaccine is scheduled for 03/25/21, an ultrasound and diagnostic mammogram is scheduled for 04-26-21. As of today 03-14-21, the swelling in the armpit has resolved, the lump in the breast is now ~75% smaller than when originally discovered. No fever or streaking noted.
49 2021-03-15 swelling face Fever, left side face swelling and drooping
49 2021-03-16 lymph node pain On 1/18/2021 I started having very swollen lymph nodes they were very painful it lasted about 2 mont... Read more
On 1/18/2021 I started having very swollen lymph nodes they were very painful it lasted about 2 months to go completely away.
49 2021-03-16 lymph node swelling hair loss/eyebrows, cervical lymph node swelling, general itching, weakness Narrative: Vaccinated 3/... Read more
hair loss/eyebrows, cervical lymph node swelling, general itching, weakness Narrative: Vaccinated 3/4/2021, onset of hair loss 3/13/2021, lymph nodes 3/9/2021
49 2021-03-17 lymph node swelling enlarged lymph node under left arm
49 2021-03-18 swelling face, lymph node swelling Day after shot felt very tired with headache and sore all over especially joints. Starting on the m... Read more
Day after shot felt very tired with headache and sore all over especially joints. Starting on the morning of the second day after swelling in glands around my underarm. The one between my underarm and breast is the size of about 2.5 golf balls placed side by side. Some swelling in face on same side and gland under cheek, near ear swollen. All very sore and uncomfortable.
49 2021-03-20 lymph node swelling Fevers throughout the day of the vaccine and the following day. Body aches the first two days. Left... Read more
Fevers throughout the day of the vaccine and the following day. Body aches the first two days. Left armpit glands are swollen.
49 2021-03-21 swelling skin red and some white blotchiness. small raised ares( hives) warm to touch. exceptionally itchy ... Read more
skin red and some white blotchiness. small raised ares( hives) warm to touch. exceptionally itchy legs,back, abdomen, arms, armpit,elbow, behind knee - all affected.
49 2021-03-22 lymph node swelling Within one hour of injection: tingle in tongue (resolved in 24 hours), headache, low-grade fever, fa... Read more
Within one hour of injection: tingle in tongue (resolved in 24 hours), headache, low-grade fever, fatigue (on and off for 3 days), injection site pain, red and hot injection site (resolved after 3 days). Within 12 hours of injection: lip swelling (occurred 10 hours after injection, resolved within 24 hours, note: no lip fillers). Within 48 hours of injection: swollen lypmh nodes in left armpit (resolved within 12 hours).
49 2021-03-22 swelling face bumps in mouth on first day, face turned read on second day and bumps went away, third day lips beca... Read more
bumps in mouth on first day, face turned read on second day and bumps went away, third day lips became raw and almost wind burned and chapped then fourth and fifth day lips swelled up very large as well as chin and lower face and cheeks. Benadryl, claritin given together as well as epi pen for emergency use.
49 2021-03-25 anaphylactic reaction Pt got dose of vaccine Pfizer bionTech Lot # EL1283 with exp 10/22 and had an anaphylactic reactio... Read more
Pt got dose of vaccine Pfizer bionTech Lot # EL1283 with exp 10/22 and had an anaphylactic reaction with dizziness, tongue swelling and shortness of breath. Vaccine given in tent. Pt felt she was going to fall and was assisted down. She was diaphoretic and tongue swollen. Epi pen was administered. Pt with history of sever allergic reaction as a child but has never used epi pen in adult life and sensitive to flu vaccine with eggs. Pt taken to ER.
49 2021-03-25 swelling face Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Me... Read more
Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Additional Details: bp 175/110 hr 76 and bp 15 min later 158/100 hr 72 and on bp meds
49 2021-03-27 lymph node swelling Minor injection site pain followed by chills, high fever, SOB, dizziness, weakness, blurred vision, ... Read more
Minor injection site pain followed by chills, high fever, SOB, dizziness, weakness, blurred vision, severe muscle pain, and large swollen lymph node (size of golf ball under left arm/near injection site) 12 hours after second shot. Adverse events diminished 12 to 48 hours later.
49 2021-03-29 lymph node swelling At 10 minutes, tongue irritation. At 25 minutes, hives on palm of hand which resolved after 10 minut... Read more
At 10 minutes, tongue irritation. At 25 minutes, hives on palm of hand which resolved after 10 minutes. At 90 minutes, drop in blood pressure, dizziness, weakness, severe stomach cramps, nausea, vomiting, diarrhea, tightness in chest and head. Took Benadryl, Albuterol and Pepcid. One hour later, 103 fever, severe pain in all joints. Stayed on Benadryl for 24 hours. Once Benadryl was stopped, developed hives all over chest, various spots on arms and stomach, continued dizziness, swollen lymph node in arm pit. Eyes were swollen and itchy. and red. Resumed Benadryl x5 days, every time Benadryl stopped, hives resumed. . Periodic hives still surface as of this date but mostly improved. My MD suggested I report event.
49 2021-03-29 lymph node swelling 2 supraclavicular nodes on L (node 1- size of dime; node 2- size of penny); nodular swelling noted o... Read more
2 supraclavicular nodes on L (node 1- size of dime; node 2- size of penny); nodular swelling noted on March 28, 2021; symptoms still present. L arm swelling/ tenderness/ pain at injection site noted on March 27, 2021; symptoms are improving.
49 2021-03-30 anaphylactic reaction Anaphylactic reaction: other; This is a spontaneous report received from a contactable consumer (pat... Read more
Anaphylactic reaction: other; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient (not pregnant) received BNT162B2 (lot number: EN6205) second dose on 06Mar202111:00 on Right arm at single dose for COVID-19 immunization. Medical history included Asthma, allergies to Sulfa, CT dye, Reglan, Morphine, and Gastrointestinal issues. Concomitant medications within 2 weeks of vaccination included Omeprezole, metformin, fluticasone propionate, salmeterol xinafoate (ADVAIR), cetirizine hydrochloride (ZYRTEC), galcanezumab (EMGALITY). No other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 first dose on 13Feb2021 13:00 (age at vaccination was 49-year-old) on Right arm for COVID-19 immunization. Patient had Adverse events: Anaphylactic reaction: rash, itching, cough, throat swelling and closing, difficulty breathing, rapid heart rate, face swelling, eye problems, dizziness, nausea, headache on 06Mar2021 11:15. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient received treatment included Epinephrine, Benadryl injections, O2, Breathing Tx. Prior to vaccination,was the patient was not diagnosed with COVID-19, Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was Recovered with lasting effects.
49 2021-03-30 axillary mass I got the vaccine on Monday, March 29th around 1:30 pm, I was perfect, don't even arm pain. In the e... Read more
I got the vaccine on Monday, March 29th around 1:30 pm, I was perfect, don't even arm pain. In the early morning of the 31st, around 2:00 am, I felt pain under my armpit that was reflecting towards the left breast. I also felt pressure in my left arm but more toward my forearm and a discomfort in the left side of my core and in my back (left side). I sat up, raise my arm and felt a lump of about 3 inches in diameter, under my armpit. I took Naproxen of 500Mg.
49 2021-03-30 lymph node swelling fever; headache; Lymphadenopathy, axillary left arm. Mild for 1st dose, moderate-severe for 2nd dose... Read more
fever; headache; Lymphadenopathy, axillary left arm. Mild for 1st dose, moderate-severe for 2nd dose, still present 13 days post 2nd dose. Mild lymphadenopathy other axilla; This is a spontaneous report from a contactable Other Health Professional. A 49-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20Jan2021 14:30 (Batch/Lot Number: EL8982) as single dose for covid-19 immunization. Medical history included historical vaccine, dose 1 via an unspecified route of administration, administered in Arm Left on 30Dec2020 at 14:45 (Batch/Lot Number: EJ1685) as single dose for covid-19 immunization. Concomitant medication included lansoprazole (PREVACID) taken for an unspecified indication, from unspecified date. Lymphadenopathy, axillary left arm. Mild for 1st dose, moderate-severe for 2nd dose, still present 13 days post 2nd dose. Mild lymphadenopathy other axilla on 02Jan2021 08:00 AM. The patient had fever and headache The patient was treated ibuprofen for fever and headache. The patient underwent lab tests and procedures which included, Nasal Swab (labcorp pixel): negative on 29Jan2021. Facility type vaccine is Clinic Name. The outcome Lymphadenopathy, axillary left arm. Mild for 1st dose, moderate-severe for 2nd dose, still present 13 days post 2nd dose. Mild lymphadenopathy other axilla was not recovered and outcome for fever and headache was unknown.
49 2021-03-30 swelling face Developed rash on contralateral arms @ 20 minutes then spread to rest of body. Then developed SOB/fa... Read more
Developed rash on contralateral arms @ 20 minutes then spread to rest of body. Then developed SOB/facial swelling. Received Epi pen x1 with some response, and brought to ED. VS remained stable 150-160/100-110. Exam notable for diaphoresis, RRR, CTAB no wheezes.
49 2021-03-31 anaphylactic reaction reported to onsite medical clinic at 11:30am after taking 2 puffs of albuterol, c/o HA/lightheaded/d... Read more
reported to onsite medical clinic at 11:30am after taking 2 puffs of albuterol, c/o HA/lightheaded/dizzy, VSS, developed mild SOB/clammy/groggy, sent to Emergency Room for evaluation and treatment where it was documented that she had an anaphylaxis reaction to the vaccine administered at 0800 on the same day at a community vaccination event
49 2021-03-31 lymph node swelling Developed body aches, chills for total of four days after vaccine and symptoms resolved. Then a week... Read more
Developed body aches, chills for total of four days after vaccine and symptoms resolved. Then a week after recieving the vaccine she developed arm pain around site of injection, a bright red rash, and swollen, tender lymph nodes at right axillae.
49 2021-04-01 lymph node swelling A little bit of pain at the arm and fatigue. Approximately one week later on 4/22, I noticed 2 pea-s... Read more
A little bit of pain at the arm and fatigue. Approximately one week later on 4/22, I noticed 2 pea-sized swollen supraclavicular lymph nodes and have extreme collar bone and a/c joint/shoulder pain. I read case studies about other vaccine recipients who had a lymphadenopathy in similar areas, so I will wait to see if it clears up before seeing a doctor.
49 2021-04-01 swelling face Patient reported hives on arms along with rednes @ 1215s. Diphenhydramine 50 mg PO was given to pati... Read more
Patient reported hives on arms along with rednes @ 1215s. Diphenhydramine 50 mg PO was given to patient @ 1218. At 1225 patient reported facial swelling and redness with edema noted. Patient declined a rapid response team be called (to escort to emergency department) and declined IM epinephrine. She reported that she has had anaphylactic reactions and she knows that she needs steroids. Patient was escorted to the emergency department @ 1228. ED MD noted no hives on arms and no rash but several scatted hives on back. No symptoms consistent with anaphylaxis noted and patient improved with oral diphenhydramine and was ultimately discharged from the ED.
49 2021-04-02 lymph node swelling, lymph node pain Right arm pit is swollen. Lymph nodes are sore and puffed up. Big noticeable bubble where armpit is;... Read more
Right arm pit is swollen. Lymph nodes are sore and puffed up. Big noticeable bubble where armpit is; Lymph nodes are sore and puffed up. Big noticeable bubble where armpit is; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9264), via an unspecified route of administration on Right arm on 08Feb2021 12:00 (at the age of 49-years-old) at a single dose for COVID-19 immunization. Medical history included back disorder and Chronic back problems. Concomitant medications within 2 weeks of vaccination were not reported. No Allergies to medications, food, or other products was reported. The patient experienced right arm pit is swollen, lymph nodes are sore and puffed up and big noticeable bubble where armpit is on 09Feb2021 05:00. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The outcome of events were not recovered.
49 2021-04-02 swelling face 8:06 am Patient having feeling of swollen tongue and face puffing
49 2021-04-03 lymph node pain lymph nodes left arm pit very sore; Soreness at injection site; Chills; This is a spontaneous report... Read more
lymph nodes left arm pit very sore; Soreness at injection site; Chills; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non pregnant female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: unknown), via an unspecified route of administration on 12Feb2021, 10:45 AM at arm left as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.no other vaccine was administered in 4 weeks. The patient was on birth control. On 13 Feb 2021, at 05:00Am the patient experienced Soreness at injection site Chills and No fever. on 14 Feb 2021, she had lymph nodes left arm pit and it was very sore. The outcome of events was not recovered. Information on the lot/batch number has been requested.
49 2021-04-03 lymph node swelling Fever and chills, then very painful right shoulder joint and very swollen lymph in right axilla.
49 2021-04-05 swollen extremities, swelling face At 24 hours, in a very short period of time, my temp went from normal to 104.9, I got chills; and m... Read more
At 24 hours, in a very short period of time, my temp went from normal to 104.9, I got chills; and my fingers, hands and lips turned blue. I went to urgent and they think because my fever went up so rapidly, my blood vessels constricted. I went home, alternated Tylenol and Ibuprofen during the night. On the morning of the 22nd, I woke up and my face was really swollen along with swelling under my armpit. I was also really hoarse. I went back to urgent care and they put me on a steroid, Benadryl and Pepcid. After that, everything slowly improved. It took a while for me to recover fully.
49 2021-04-05 peripheral swelling Arm started sore 4 hours after vaccine, next morning same, by 3 pm it was swollen, red, hot to touch... Read more
Arm started sore 4 hours after vaccine, next morning same, by 3 pm it was swollen, red, hot to touch, by 5:30 it was itching with bumps, neck pain, headache, fever of 101.
49 2021-04-06 lymph node swelling Swollen nodes under armpit and above clavicle. Feels hot and burning pain under armpit and arm.
49 2021-04-06 peripheral swelling 4/3- 10:45 am Shot given. Immediate warm feeling in arm 11:00 am by the end of the waiting period... Read more
4/3- 10:45 am Shot given. Immediate warm feeling in arm 11:00 am by the end of the waiting period arm hurt, felt heavy and stiff 12:00 pm dull headache, loss of appetite 3:00 pm low grade temp: 99.1 body aches 6:00 pm temp: 100.2, husband noticed left arm was severely swollen, tight, and hot. No rash or change in color. 10:00 pm and Throughtout the night: Chills, sweats, severe body aches, severe headache (could barely lift my head off the pillow), elevating fever, left arm felt heavy, hot and swollen, 4/4-5:00 am temp: 102.9, took 600 mg ibuprofen Slept well 8:00 am: temp 100 No body aches, chills, sweats. All other symptoms continued About 1:30 pm temperature increased again. It topped out at 101.5 in the evening. Took 600 mg ibuprofen. Slept all night. 4/5- wake up temp: 99.1 continued headache, nausea, heavy feeling throughout body Temp throughout the day ranged from 99.1-99.7. Headache dissipated about mid-day. 4/6- temp 98.5 upon wake up. By mid-morning all symptoms had dissipated, but still linger in the background. More energy. 4/7- normal temperature. Increased energy, returned to work. Mid-day, mild tummy issues and lightheadedness returned.
49 2021-04-06 swelling face, peripheral swelling None at time of shot except tenderness in injection area and arm soreness. About 40 hours later, swe... Read more
None at time of shot except tenderness in injection area and arm soreness. About 40 hours later, swelling of face (lips) and hands, high histamine.
49 2021-04-12 swelling, axillary mass Following vaccination went home and started to feel a soreness in the left side of my neck. I now f... Read more
Following vaccination went home and started to feel a soreness in the left side of my neck. I now feel a small lump in the area where there was none before and it hurts when I touch it and when I move my neck. The next day I noticed a similar lump underneath my arm o the right side of my body as well.
49 2021-04-12 swelling, peripheral swelling Patient recieved vaccine at 10 AM at a school COVID clinic. She waited 30 minutes and went home. At ... Read more
Patient recieved vaccine at 10 AM at a school COVID clinic. She waited 30 minutes and went home. At around 11 AM, she felt pain in her neck and down her arm. She also stated she felt a little swollen in her throat, tongue, eyes, and ears. She said it was not swelling shut, but just an uncomfortable and never felt in danger. Her hands and chest also had a tightness and swelling to them. Later that night she had a headache behind her eyes. By Saturday she was fine with the "swollen" feeling. However, by Monday, she had a rash begin on her hands and stomach. The rash was described as a chicken pox rash. She said this just went away over the last couple of days and did leave very little scarring.
49 2021-04-13 anaphylactic reaction, swelling Anaphylactic Reation. everything swelled and rash appeared, couldn't swallow, throat constricting. ... Read more
Anaphylactic Reation. everything swelled and rash appeared, couldn't swallow, throat constricting. Epinephrine injection, Racepinephrine, diphenhydramine methlprednisolone, famotidine Day after feel like run over by a truck and nausea, feel sick, headache, joint pain not sure how long everything will last or if more will appear
49 2021-04-13 swollen extremities, lymph node swelling Injection site warm and swollen. Axillary lymph node very enlarged and painful with pain radiating ... Read more
Injection site warm and swollen. Axillary lymph node very enlarged and painful with pain radiating up the right side of my neck, into my shoulder blade and down my right arm.
49 2021-04-13 peripheral swelling After receiving my second shot of the Pfizer vaccine on 03/27/2021, On 04/04/2021, my left arm star... Read more
After receiving my second shot of the Pfizer vaccine on 03/27/2021, On 04/04/2021, my left arm started hurting and then it started swelling. The following 2 days, my ankles and legs got swollen.
49 2021-04-14 lymph node pain, lymph node swelling Acute onset supraclavicular lymphadenopathy on the left side that started 6 days after receiving the... Read more
Acute onset supraclavicular lymphadenopathy on the left side that started 6 days after receiving the vaccine. Pain and swelling with a possible palpable lymph node. No fever or any other symptoms. Pruritic rash, very small localized papules, on the elbow of the same arm appeared in the same day as the vaccine and resolved spontaneously in 5 days.
49 2021-04-14 lymph node pain, lymph node swelling Patient contacted clinic with concerns of tenderness and pain and a description of swollen lymph nod... Read more
Patient contacted clinic with concerns of tenderness and pain and a description of swollen lymph nodes near clavicle.
49 2021-04-14 lymph node swelling Softball size lump at injection site, swollen lymph nodes under armpit, swollen lymph nodes in neck.... Read more
Softball size lump at injection site, swollen lymph nodes under armpit, swollen lymph nodes in neck. All reactions lasted for 10 days.
49 2021-04-14 swelling face Sore and achy body, no energy, slept for two days straight. Also right side of my face swelled up an... Read more
Sore and achy body, no energy, slept for two days straight. Also right side of my face swelled up and became super itchy on the day after the vaccine, by the second day it was only my eye (swelled shut and looked like black eye). One day three after swelling down but still looks like black eye. Now on day 4 after- less swollen but still itchy and swollen and black.
49 2021-04-15 lymph node swelling, swelling 1. Non-anaphylactic allergy (itchy throat, swollen lymph nodes, generalized swelling (couldn't take ... Read more
1. Non-anaphylactic allergy (itchy throat, swollen lymph nodes, generalized swelling (couldn't take ring off))...about 15 mins after shot...took Benedryl 2. Severe headache...about 25 mins after shot...lasted almost exactly 24 hours...took tylenol 3. Injection site/arm pain...also lasted about 24 hours
49 2021-04-15 lymph node swelling within a couple hours of receiving the vaccine i had a headache and felt tired. at 3am that evening... Read more
within a couple hours of receiving the vaccine i had a headache and felt tired. at 3am that evening i woke up with muscle, joint, bone aches that lasted through the night, uncomfortable enough that it prevented me from sleeping. I took tylenol the next morning and it felt better. by 2PM the next day I had a fever of 100. It increased to 101.5 by 6pm. i had chills, body aches, felt horrible (flu like). it started to go down around 9pm. I woke up the morning of the 16th feeling much better (vaccine was given morning of 14th), all symptoms gone, EXCEPT my armpit is hugely swollen and painful. it has grapefruit sized swelling and throbs. it is under my right arm, which is the same side I had the vaccination on.
49 2021-04-15 swelling face Face swelling, tongue swelling evening after vaccine. 2 days after vaccine until now, I have had an... Read more
Face swelling, tongue swelling evening after vaccine. 2 days after vaccine until now, I have had an increase in fatigue that I normally have due to long covid (original infection 8/13/2020).
49 2021-04-15 swelling face On April 11th, woke up with a swollen left eye and upper cheek, with redness. On April 12th, woke up... Read more
On April 11th, woke up with a swollen left eye and upper cheek, with redness. On April 12th, woke up with left eye nearly swollen shut, and entire left side of face red and puffy. As the day progressed, blisters appeared and began weeping. Which does sound like it could be a poison weed, right? I had zero contact with any poison ivy, sumac, oak, etc. I had not changed my diet, changed any soaps/detergents, etc. Contacted primary care provider who diagnosed issue as poison ivy and prescribed 40 mg of prednisone for 3 days, 20 mg for 2 days. By Thursday April 14th, issue was not improving and my entire face was swollen, red, hot and itchy. Went to the urgent care clinic who conferred with my primary doctor and they decided to increase my prednisone treatment to 60 mg for 3 days, 20 for 3 days. As of today, April 16th, the prednisone treatment does not appear to be helping, as face is still red, swollen, hot and itchy. This has also spread to my neck area, but not any where else on my body.
49 2021-04-15 white blood cell count increased hematuria. fevers, abdominal pain, fever 101, bodyaches
49 2021-04-16 lymph node pain Painful lymph nodes in neck-above collar bone began 7 days after vaccination. Shortness of breath. F... Read more
Painful lymph nodes in neck-above collar bone began 7 days after vaccination. Shortness of breath. Fatigue. Headache. Muscle soreness.
49 2021-04-16 swelling face Tingling in tongue within the hour after vaccine Metal taste in mouth day of vaccine 24 hours after ... Read more
Tingling in tongue within the hour after vaccine Metal taste in mouth day of vaccine 24 hours after vaccine, left side of face swelling. I have no fillers. Day 3 face still swollen.
49 2021-04-16 swelling face Eye bulging, face swelling, tachycardia. ER visit to stabilize, Opthomologist for eye bulge, Primar... Read more
Eye bulging, face swelling, tachycardia. ER visit to stabilize, Opthomologist for eye bulge, Primary care doctor for further testing, blood labs, endocrinologist visit and additional labs. Vision care for vision loss.
49 2021-04-17 lymph node swelling Side effects started with a headache and fatigue about 8 hours after shot. Did not sleep well, took ... Read more
Side effects started with a headache and fatigue about 8 hours after shot. Did not sleep well, took Tylenol in morning since headache did not go away. Headache came and went during the day after the shot. Not that severe. Also fatigue and slight muscle aches. Took about 3 dozes of Tylenol during that 24 hour day. Slept much better the 2nd night, awoke with left armpit hurting. There seems to be a lump in the left armpit and I assume it is a swollen lymph node. Continuing to hydrate a lot and rest as needed. Avoiding Tylenol unless pain gets severe. No signs of fever, some muscle aches in left arm. Injection site got more sore after 12 hours but is almost gone at 36 hours.
49 2021-04-17 lymph node swelling After my shot, I had low fever and was tired and reported those on the daily checker. On 4/16 my ri... Read more
After my shot, I had low fever and was tired and reported those on the daily checker. On 4/16 my right side lymph node on neck/ear/face started swelling and on Saturday it was very swollen and also noticed swollen lump at injection site on right arm, and both still there today...Sunday
49 2021-04-17 lymph node swelling Swollen lymph node in groin area; This is a spontaneous report from a contactable consumer (patient)... Read more
Swollen lymph node in groin area; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6208), via an unspecified route of administration, administered in gluteus medius right on 25Mar2021 at 09:00 as single dose for COVID-19 immunization. Medical history included ER+/HR+HER2- IDC and DCIS, left breast. The patient did not had allergies to medications, food, or other products. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), via an unspecified route of administration, administered in right buttocks on 04Mar2021 09:00 as single dose for COVID-19 immunization. Concomitant medication(s) included acetylsalicylic acid (BABY ASPIRIN), fish oil (OMEGA 3 FISH OIL [FISH OIL]) and curcumin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced swollen lymph node in groin area on 27Mar2021 at 06:00. The patient did not received treatment for the adverse event. The outcome of event was not recovered. The reporter classified the event as non-serious. No follow-up attempts are needed. No further information is expected.
49 2021-04-17 lymph node swelling her glands are still swelling; she still has excessive sweating; she is bleeding so much and feels l... Read more
her glands are still swelling; she still has excessive sweating; she is bleeding so much and feels like crap/Really bad periods the worst in 30 years; Burning of ribs Feeling like they are on fire; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular, administered in Arm Left on 29Jan2021 10:00 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included stress, allergies to Sulfa and Penicillin from an unknown date and unknown if ongoing. The patient was Intolerant to Codeine and Dilaudid. The patient previously took first dose of BNT162B2 on 08Jan2021 12:00 Lot Number: EL0142 for Covid-19 immunization and experienced Lymph swollen, Excess sweating, Headache and Sore. The patient experienced she is bleeding so much and feels like crap/really bad periods the worst in 30 years on 02Mar2021 02:00, burning of ribs feeling like they are on fire on 29Jan2021, her glands are still swelling on an unspecified date and she still has excessive sweating on an unspecified date. The outcome of the events was reported as Not recovered. Information on the lot/batch number has been provided. Other information has been requested.
49 2021-04-18 swollen extremities Caused severe swelling , and pain in my arm pit on the right side where the shot was administered.
49 2021-04-19 axillary mass Lump in left armpit, same side as vaccine (second dose),, VERY painful and makes arm movement (up, ... Read more
Lump in left armpit, same side as vaccine (second dose),, VERY painful and makes arm movement (up, above, back, and neutral) very uncomfortable and painful. Pressing on the bump causes a dripping feeling under the skin near the left breast. Have a doctor's appointment coming up. Lie bump (tonight ulcer), painful Severe back pain (had to visit spine specialist), need further testing
49 2021-04-20 lymph node swelling Day 1: Fever, chills Day 2: swollen lymph nodes under armpit; dizziness
49 2021-04-20 pancreatitis Headache, nausea, fatigue, malaise, two days later woke up at 4am with severe abdominal pain, caused... Read more
Headache, nausea, fatigue, malaise, two days later woke up at 4am with severe abdominal pain, caused pancreatitis flare and then diagnosed with thrombosis of hepatic and portal vein. Hospitalized for 11 days post diagnosis of pancreatitis and other complications after vaccination.
49 2021-04-21 systemic inflammatory response syndrome Patient received first COVID vaccine 3/29/21. Patient received second COVID vaccine 4/19/21 in the ... Read more
Patient received first COVID vaccine 3/29/21. Patient received second COVID vaccine 4/19/21 in the morning - patient developed headache and severe vomiting throughout the day 4/19/21 resulting in diabetic ketoacidosis (glucose 583 mg/dL) and systemic inflammatory response syndrome (SIRS) - patient admitted 4/19/21 in evening to ICU - patient discharged 4/21/21. Patient states she had COVID disease last year.
49 2021-04-22 lymph node swelling, peripheral swelling, swelling face, lymph node pain All this on the right side of the body. Injection site was on the right arm. Dizziness and weaknes... Read more
All this on the right side of the body. Injection site was on the right arm. Dizziness and weakness, swollen/painful lymph nodes (axillary, cervical, epitrochlear, under jawline and chin). Parotid gland swollen and painful. Entire right arm swollen with rash, Right check swelled. Right ear pain.
49 2021-04-22 swollen extremities Caller describes soreness in her arm and swelling under her armpit
49 2021-04-22 peripheral swelling Sore swollen arm Headache Chills Fever of up to 103
49 2021-04-22 swelling face Hives and welts appeared on my body and continue 5 days later. My face started to swell badly and I... Read more
Hives and welts appeared on my body and continue 5 days later. My face started to swell badly and I ended up on the ER. I have been advised to not get the second shot. This has been very bad, and showing no signs of letting up.
49 2021-04-23 lymph node swelling Swollen lymph nodes; pain in right armpit; Stiff neck; Dizziness; Fatigue; Headaches; This is a spon... Read more
Swollen lymph nodes; pain in right armpit; Stiff neck; Dizziness; Fatigue; Headaches; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration in right arm on 17Feb2021 15:00 as single dose and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9262) on 27Jan2021 15:00 in right arm as single dose for covid-19 immunization. Patient was 49-years-old and was not pregnant at the time of vaccination. Medical history included chronic migraine. Concomitant medication included sumatriptan succinate (IMITREX). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen lymph nodes and pain in right armpit, stiff neck, fatigue, dizziness, headaches on 18Feb2021 15:00. No treatment received for reported events. Patient not tested for COVID-19 after the vaccination. The outcome of the events was not resolved.
49 2021-04-24 anaphylactic reaction I waited about 30 minutes. Felt tingly and a bit light headed but cracked it up to being tired from... Read more
I waited about 30 minutes. Felt tingly and a bit light headed but cracked it up to being tired from the shot. I got in my car and about 5 minutes out driving in the middle of traffic, I felt like I was going to pass out like I had once before with anaphylaxis- at the wheel. There is no mistaking the feeling. I could not feel my pulse at all. Fortunately I had a EpiPin in my car and I was able to jab it in my leg and within a minute or two I had the energy to turn the car around and get back to the folks at site who were wonderful. I then took benadryl as advised and the EMS were called. I was taken to site where they gave me a steriod, pepsid and monitored me until I went home later that evening. I was told to take benadryl for the next 24 hours and I did.
49 2021-04-24 lymph node pain, lymph node swelling Painful, itchy swollen armpit / lymph nodes and dry, sore lips
49 2021-04-24 lymph node swelling Chills, numbness, tingling from shoulders to hands (tip of fingers), swelling of lymph nodes Sympto... Read more
Chills, numbness, tingling from shoulders to hands (tip of fingers), swelling of lymph nodes Symptoms are getting worse since Wednesday
49 2021-04-24 swelling face After sitting at the vaccination clinic for the required 15 minute, on the way home I noticed my li... Read more
After sitting at the vaccination clinic for the required 15 minute, on the way home I noticed my lips started to swell. Shortly thereafter my face started to swell. I asked my husband to take me to the emergency room, and it was noted in my charts that I had had an adverse reaction. I thought that was going to be the only symptom, but later on in the week I experienced vertigo, nausea, and my stomaching lurching. On Friday the week of my vaccination I noticed that my that my lips and face started to swell again, but went down shortly thereafter. My face and lips also started to swell today, but again went down. I told my husband is it happening because of stress or heat? I really do not understand why I am experiencing symptoms a week after my vaccine.
49 2021-04-24 swelling Full body rash and rash is worse around elbow, hip and knees. Swelling of areas where rash is worse... Read more
Full body rash and rash is worse around elbow, hip and knees. Swelling of areas where rash is worse started to appear a few days after second dose
49 2021-04-25 lymph node swelling Swollen lymph node on neck.
49 2021-04-25 peripheral swelling lt arm swollen, legs and feet swollen, hissing sound in head, bruising on arm, swollen stomach, swol... Read more
lt arm swollen, legs and feet swollen, hissing sound in head, bruising on arm, swollen stomach, swollen hands, redness aeound neck and breast are
49 2021-04-25 swelling Full body rash, red bumps, skin swells all over the full body, full arms, full legs and feet, butts... Read more
Full body rash, red bumps, skin swells all over the full body, full arms, full legs and feet, butts, chest. Itchy but not painful. First Treated with two 24-hr Allegra per say plus Benadryl every 4 hours and Clobetasol Propionate cream for 3 days. No improvements. Added prednisone treatment on the 4th day for 12 days.
49 2021-04-26 lymph node swelling Swelling of lymph nodes in the throat bilaterally and hives inside the mouth.
49 2021-04-26 lymph node swelling About 3 to 4 days after injection,I noticed swollen nodes under my left(injection arm); Rash on left... Read more
About 3 to 4 days after injection,I noticed swollen nodes under my left(injection arm); Rash on left,Rash worsened on my left arm expanded to my torso, right arm and legs; This is a spontaneous report from a contactable Other health care professional. A 49-year-old female non-pregnant patient (Other HCP) received first dose BNT162B2 (Pfizer Covid vaccine, Solution for injection, Lot number: EN5318) via an unspecified route of administration in arm left on 06Feb2021 11:00 AM at single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis. Concomitant medications included Levothyroxine, vitamin D (COLECALCIFEROL). No covid prior vaccination and no covid tested post vaccination. On 10Feb2021, the patient reported that about 3 to 4 days after injection, patient noticed swollen lymph nodes under her left arm (injection arm) and rash on left arm. Rash worsened on patient left arm, expanded to her torso, right arm, and legs. The patient received treatment for the events via unspecified treatment medications as anti-itch meds, antihistamine and steroid pack. The outcome for the events was not recovered.
49 2021-04-26 peripheral swelling 3 hours after Covid vaccine pt experienced itchy skin, chest tightness, trouble breathing and swelli... Read more
3 hours after Covid vaccine pt experienced itchy skin, chest tightness, trouble breathing and swelling of the arms, nasal congestion. The next day, developed a rash on the neck area. Pt took loratidine, hydroxyzine, benadryl and used hydrocortisone cream and had improvement after 4 days.
49 2021-04-27 lymph node swelling First day had joint pain and fatigue. Second day joint pain had minimized and fatigue was gone. Ho... Read more
First day had joint pain and fatigue. Second day joint pain had minimized and fatigue was gone. However, also has swollen and tender lymph nodes in arm pit and neck, but especially under arm
49 2021-04-27 lymph node swelling Chills, night sweats, muscle and joint ache, slight throat pain, lymph node swelling in right arm pi... Read more
Chills, night sweats, muscle and joint ache, slight throat pain, lymph node swelling in right arm pit, slight loss of appetite
49 2021-04-27 lymph node swelling This is a spontaneous report received from a contactable consumer (patient). This 49-year-old non-pr... Read more
This is a spontaneous report received from a contactable consumer (patient). This 49-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 26Mar2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (lot number unknown) on 12Mar2021 at 11:00 (at the age of 49-years-old) in the right arm for COVID-19 immunization. The patient reported experiencing swollen lymph nodes in both armpits, groin, and abdomen on 27Mar2021 at 06:00. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the event. The clinical outcome of swollen lymph nodes in both armpits, groin, and abdomen was not recovered, the clinical outcome of second dose administered on 26Mar2021 was recovered on 26Mar2021 at 14:00. It was also reported that the patient had not been tested for COVID-19 since vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
49 2021-04-28 oral herpes Cold sore appeared soon after COVID vaccination
49 2021-04-28 swelling face About 15 minutes after recievieng the vaccine I developed hives on my hands and arms, feet and legs.... Read more
About 15 minutes after recievieng the vaccine I developed hives on my hands and arms, feet and legs. I also had some swelling of my lip and some mild chest tightness. I was treated with oral Pepcid and Oral Zyrtec. My hives resolved after about 15 minutes as did my mild chest tightness. I was observed for an hour. Later that evening about 8, my face and lip began to swell, I had significant chest tightness, with severe coughing and wheezing. I also had hives again on my hands, neck and face. I used my Epipen and albuterol inhaler. My chest was still very tight and my cough was very bad. I went to the emergency room. I was given DuoNeb, Pepcid, Benedryl, and Prednisone. They were unable to start an IV so gave me oral medications. Over the next hour my symptoms resolved and I felt much better. I was discharged about midnight. Today I have a very sore throat from coughing so much and my body is very achy and I have diarrhea. I have had this same issue however the last time I needed to use Epi when I accidentally ate Shrimp.
49 2021-04-29 anaphylactic reaction Went to ED after vaccination reaction - diagnosis: Anaphylaxis CHIEF COMPLAINT: POSSIBLE ALLERGIC ... Read more
Went to ED after vaccination reaction - diagnosis: Anaphylaxis CHIEF COMPLAINT: POSSIBLE ALLERGIC REACTION (ptjust had 2nd COVID vaccine. c/o voice changes and changes in swallowing. pt is able to maintain secretions at triage. ) DIAGNOSIS at time of disposition: 1. Anaphylaxis, initial encounter This is a 49-year-old female that presents emergency department 1 hour after receiving her 2nd COVID vaccine (pfizer), and states that she waited her 15 minutes after receiving the shot and felt fine. She then reports that when she got to the car she started feeling some chest tightness a bit of more difficulty with her breathing and felt like her throat was scratchy and a bit tight as well. She has had complications with taking the flu vaccine as well as a tetanus shot. Where she has had rashes then enlarged lymph nodes. But never this reaction. She has never been hospitalized or brought to the ER due to anaphylaxis. She does not use an epinephrine pen at home. Patient states before the shot she was feeling well. She does not have any systemic symptoms like fever, nasal congestion or sore throat. Patient also denies any recent episodes of vomiting or diarrhea. This patient came in the emergency department was concerning signs and symptoms for anaphylaxis. The patient was immediately given a dose of IV Solu-Medrol 125 mg, IV Benadryl 50 mg, and 20 mg of IV Pepcid. Patient was placed on cardiac monitor. I went back to re-evaluate the patient she was feeling significantly improved within a short period of time. Patient was monitored in our emergency department for most 2 hours. Patient's symptoms had resolved. Patient was comfortable being discharged home. Patient has several allergies in her history. Patient was sent home with a prescription for prednisone as well as Pepcid. Patient also given a prescription for an epinephrine pen and told and instructed on how and when to use this. The patient is going to have someone pick her up as she was instructed that the Benadryl can make her very drowsy and a would be rather unsafe to drive. She was going to contact a family member to pick her up. Patient will return if she has any more symptoms
49 2021-04-29 white blood cell count increased ischemic stroke. tpa administered. transferred to higher level of care at 1300
49 2021-04-30 oral herpes Multiple Cold Sores on my bottom lip.
49 2021-04-30 peripheral swelling Presented to ED with swelling to right leg. Had ultrasound and has a DVT. Normal cardiopulmonary exa... Read more
Presented to ED with swelling to right leg. Had ultrasound and has a DVT. Normal cardiopulmonary exam with LCTAB and HRRR. No swelling to R calf. R calf is warm to touch, red, and TTP. Patient is well appearing, non-toxic and in no acute distress. Patient's US of the RLE that revealed a R calf DVT involving mid calf posterior tibial vein from her Dr.'s office. BMP was unremarkable. Prescribed the Patient Xarelto and she received her first dose in the ED today. Follow-up with PCP in the next 2-3 days. Return to the ED for new or worsening symptoms.
49 2021-04-30 swelling face My entire left eye socket which was completely swollen; right side face is so swollen, my chin, my c... Read more
My entire left eye socket which was completely swollen; right side face is so swollen, my chin, my cheek; Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 08Apr2021 (Lot Number: ER8733) as single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medication included amlodipine taken for hypertension; lisinopril taken for hypertension. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced right side face was so swollen, her chin, her cheek on 09Apr2021 04:00; allergic reaction on 09Apr2021 04:00; her entire left eye socket which was completely swollen on 13Apr2021 05:00. Clinical course: Patient stated she had two several reactions to the vaccine when she received this, her 2nd shot on 08Apr2021 and she was fine and she went to bed. She woke up 4 o'clock on 09Apr2021 morning and right side face was so swollen, her chin, her cheek, she called provider, who provided the vaccine, her primary care doctor saw her on 10Apr2021 and immediately he told her that probably she had an allergic reaction, so she had taken Benadryl that morning so it's go down and then 11Apr2021 night she went to the bed and she woke up on 13Apr2021 morning her entire left eye socket which was completely swollen, so and again it never happened to her before, so her husband just headed for 1st shot, after he had received information to where she would to call. She headed received that information and when she had her shot so he headed received information to call and she reflected that she had that reaction twice and in her face. Patient took the Benadryl on 09Apr2021 morning, before her whole face my right side swollen and then she took the Benadryl , she didn't take Benadryl on 11Apr2021 when she woke up, here was anything she needed to because she already had the reaction again so she woke up on 13Apr2021 morning at 5 O' Clock in the morning her whole face left eye socket and she was so swollen and it's still swollen it's going to take so long to slow down. Patient stated she still did have some swelling under the left eye, so things got slow down, she not took the Benadryl and so the major swelling gone right under the her eye, it's still pretty swollen, so If she look down take a look, she couldn't see she kind of lost. Patient stated it was still but not red but it was still there, definitely improved, because her eye was actually swollen much so on 13Apr2021 she was, it was improved. As for treatment, patient stated what she did was the 11Apr2021 when her left cheek and chin swollen, she actually took Xyzal which and that was 5 MG and 24 hours tablet. So when she went to primary care doctor on 10Apr2021, she told him that she took Xyzal, he gave her Benadryl because it would be stronger and on 13Apr2021 she took 525 MG Benadryl. Outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.
49 2021-04-30 swelling face Patient reported cheek swelling and could tell a difference when swallowing. I injected diphenhydra... Read more
Patient reported cheek swelling and could tell a difference when swallowing. I injected diphenhydramine 50mg IM into right deltoid. I monitored patient for 2 hours. She was aware the next step would be an epinephrine injection and I was prepared to administer . Over the two hour period she reported symptoms were not getting any worse. She did not want to go to emergency via squad and opted to have her husband pick her up. I reviewed epinephrine injection directions with both of them and instructed to call 911 if symptoms got any more severe.
49 2021-05-01 lymph node pain, lymph node swelling Swollen lymph node in armpit of arm that received shot; woke in morning with acute tenderness that p... Read more
Swollen lymph node in armpit of arm that received shot; woke in morning with acute tenderness that persisted for 3 days, with discomfort moving that arm and sleeping on that side; symptom gradually receded; no detectable pain after 8 days
49 2021-05-01 lymph node pain, swelling, lymph node swelling Lymph nodes on right side of body swollen so large I couldn't move my arm or leg without pain. Neck ... Read more
Lymph nodes on right side of body swollen so large I couldn't move my arm or leg without pain. Neck swelling was less extreme but still painful.
49 2021-05-01 lymph node pain The evening of the vaccine I had pain at the injection site that grew worse overnight. I repeatedly... Read more
The evening of the vaccine I had pain at the injection site that grew worse overnight. I repeatedly woke up whenever I rolled onto my left arm because of the pain. I took Tylenol the morning of the 30th. I started to get joint pain in my left elbow and fingers beginning around 9am. By 11am my whole body was sore and I was exhausted. At around 1pm I developed chills and a fever of 100.8. Beginning at 2pm I took 2 Tylenol every 4 hours. My temparature was between 99.8 and 101 until 05/01/21 at 9am. Besides the joint pain and fever, I had a headache, nausea and 2 enlarged lymph nodes: left armpit and left groin. The lymph node in my arm pit was hard, sore and got to be about as big as a small lime. It was so tender I could not put my arm down at my side. The lymph node in my going was enlarged but not as sore. I stayed in bed and slept from 5pm 4/30/21 to 9am 5/1/20. My temp when I woke up was 99.0. My only symptoms on 5/1/20 were headache and very large lymph node under left armpit. Although still large, it was softer than the day before. Today, 5/2/20 I still have headache and enlarged lymph node in left arm.
49 2021-05-01 lymph node swelling, peripheral swelling Day 1. After 15 minutes, intense hot flashes, continued all day, Left arm sore, swollen, nausea, sli... Read more
Day 1. After 15 minutes, intense hot flashes, continued all day, Left arm sore, swollen, nausea, slight headache. Day 2. Hot flashes, less intense, nausea, sore throat, slight headache, post nasal drip, slight cough and sneeze, Day 3. Swollen lymph nodes in throat, lost voice, chest sternum pain, slight headache, fatigue (called Dr). Day 4. No voice, body aches, nausea, head ache, chills, body aches, fatigue,post nasal drip, slight cough and sneeze . Day 5, chest and back pain, body aches, nausea, heartburn, still no voice, post nasal drip, slight cough and sneeze, headache, fatigue, chills. Day 6. Worst day of all! Intense headache that did not go away, almost went to Emergency Room, I was too tired to get up from the bed, body aches, chills, fatigue, still no voice, felt awful all day, I could not sleep because of the headache pounding, back hurt, it was painful to sneeze or cough,post nasal drip, slight cough and sneeze.. Day 7, Feeling slightly better, slight headache, body aches, post nasal drip, slight cough and sneeze. Day 8 felt 70% better, voice slightly returning.
49 2021-05-01 lymph node swelling Very sore throat, headache, eustachian tube pain, swollen lymph nodes (base of throat, collarbone ar... Read more
Very sore throat, headache, eustachian tube pain, swollen lymph nodes (base of throat, collarbone area, possible armpit), all on side where vaccine was given. Had sore arm the day of, but stretching the muscle helped.
49 2021-05-02 lymph node swelling 4:00am 4/28/21 - mild fever, chills, malaise/fatigue throughout the day. Moderate diffuse upper lef... Read more
4:00am 4/28/21 - mild fever, chills, malaise/fatigue throughout the day. Moderate diffuse upper left arm pain. Treatment with acetaminophen as directed on package. Fever/chills and malaise resolved by 4/29/21; arm pain reduced to mild and less diffuse. 7:30am 4/29/21 - pronounced left axillary lymphadenopathy 12pm 5/3/2021 - left axillary lymphadenopathy substantively resolved
49 2021-05-03 lymph node pain After the shot the pain went from my arm injection site to my neck and was painful. I felt tired and... Read more
After the shot the pain went from my arm injection site to my neck and was painful. I felt tired and nauseous. I went home and went to bed. The next day I had hot cold chills tiredness, and arm was incredibly painful. Then pain then spread to my armpit area and down my left breast area. . The next day my armpit was swollen up large I?m guessing the lymph nodes. It was extremely painful. I kept taking alieve and Motrin. The pain was unbearable by the Saturday evening. The next day the lump had gone down a little and I still felt under the weather. Then the pain in all my joints started. My elbows shoulders and knees being the worst. I have carried on taking pain relief but it?s has gotten so bad that I went to the dr and got given prednisone for 5 days 40 mg a day. The pain in my body is not going away. In fact I would say it?s getting worse.
49 2021-05-03 lymph node swelling, peripheral swelling, lymph node pain Fever averaging at 100.9 from 4/13/2021 thru 4/21/2021. Severe pain and swelling under arm, directly... Read more
Fever averaging at 100.9 from 4/13/2021 thru 4/21/2021. Severe pain and swelling under arm, directly below arm pit. Swelling of arm minimized by 4/21/2021, but the pain under arm by armpit persists as of today 05/04/21. Extreme lethargy form 4/13/21 thru 4/18/2021. The extreme arm pain, fever and lethargy was significant enough to go to the hospital on 4/16/2021, but I did not have the strength to shower or get ready to be taken to the hospital. Thus, I continued sleeping till the next day 4/17/2021, where I felt well enough to get out of bed, but continued to have extreme pain under my armpit and near my left breast. Significant arm discomfort, impeding my ability to perform simple household tasks such as folding laundry or lifting heavy items. till present day: 5/4/21. Severe congestion since implementation of dose 1 of Pfizer Vaccine on 4/13/2021 till present day: 5/4/2021
49 2021-05-03 swollen extremities Patient states, she received 2nd dose of pfizer COVID19 vaccination on 4/22/21 Pfizer ER8736 Since... Read more
Patient states, she received 2nd dose of pfizer COVID19 vaccination on 4/22/21 Pfizer ER8736 Since then with fatigue and generalized joint pains. Significant left arm pain (injection site), with left axilla swelling that has improved. Pt has not yet notifed VAERS.
49 2021-05-03 peripheral swelling I have ha-mrsa and the skin had a rash; Left arm swollen and red; Left arm swollen and red; I have h... Read more
I have ha-mrsa and the skin had a rash; Left arm swollen and red; Left arm swollen and red; I have ha-mrsa and the skin had a rash; Cellulite looking swelling and now skin extremely flaky and dry; Cellulite looking swelling and now skin extremely flaky and dry; Cellulite looking swelling and now skin extremely flaky and dry; This is a spontaneous report from a contactable consumer reporting for herself. A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 09Apr2021 at 17:30 (at the age of 49 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 17Mar2021 at 04:30 PM (at the age of 49 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included HA-MRSA/asthma, and had known allergies: sulfa. The patient was not pregnant at the time of vaccination. Concomitant medication included amoxicillin and doxycycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:00, the patient reported she has ha-mrsa and the skin had a rash, Left arm swollen and red, Cellulite looking swelling and now skin extremely flaky and dry. The patient did not receive treatment for these events. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
49 2021-05-04 lymph node swelling A week after the first shot I experienced large supraclavicle swelling increase on right side and an... Read more
A week after the first shot I experienced large supraclavicle swelling increase on right side and an enlarged lymph node that grew larger the following week. I also experience difficulty breathing and burning in my chest. I had no issues breathing, prior to the shot. And now I am almost a month out of my second shot and my supraclavicle swelling and lymph node are still there. I was told to give it 2 to 3 months. My chest x-ray came back with mild atelectatic changes without evidence of focal pulmonary consolidation. However, I was told I don't breath deep enough because the clusters in my lungs were not opening as they should. I didn't have this problem prior to the shot. And I am still having off and on breathing issues.
49 2021-05-05 lymph node swelling, axillary mass Patient reported lumps/swelling and pain under left arm ?lymp node area, lasted at least 3 weeks aft... Read more
Patient reported lumps/swelling and pain under left arm ?lymp node area, lasted at least 3 weeks after vaccine
49 2021-05-05 swollen extremities HUGE swelling under arm. About the volume of a softball or larger. Now, 20 days later, I am still ... Read more
HUGE swelling under arm. About the volume of a softball or larger. Now, 20 days later, I am still swollen. It is about 4 inches in diameter and feels about the volume of a racquetball. My underarm is convex, not concave like it should be. I feel a slight pinch or pressure under my arm.
49 2021-05-06 oral herpes 2 cold sores the next day after vaccine. usually get cold sores but haven't gotten one in over a yea... Read more
2 cold sores the next day after vaccine. usually get cold sores but haven't gotten one in over a year. treating with acyclovir
49 2021-05-06 swelling Fever, headache, joint pain, pain at the vaccination site, swelling, irritation, Faustian, fatigue a... Read more
Fever, headache, joint pain, pain at the vaccination site, swelling, irritation, Faustian, fatigue among others
49 2021-05-07 swollen extremities, swelling, peripheral swelling, swelling face, swelling, anaphylactic reaction Severe pain at site, arm, fingers, and shoulders for the first couple of days; and then itchiness of... Read more
Severe pain at site, arm, fingers, and shoulders for the first couple of days; and then itchiness of legs. April 27- manifestation of rash behind both knees and upper calves. April 30 swelling and edema in both calves. May 1- Swelling to left foot. Symmetrical pain in pressure points. May 2- Severe swelling to both feet, and both calves (left side, which was injection side, was worst on lower extremities). Right eye was almost swollen shut. Left eye was beginning to swell. Severe swelling to face, neck, jaw, and throat, as well as tightness of throat. Anaphylactic reaction. Emergency room visit on the May 2, May 3 was a bad day, filled with pain in joints and pressure points, as well as swelling in feet and calves. Followed up visit to pcp on May 4. Still have rash, itchiness, and swelling of lower extremities. Today, May 8, still experiencing swelling, pressure point pain, and manifestation of rash, as well as it's itchiness.
49 2021-05-07 swelling 2 weeks after vaccine noticed pain; Swelling; Tenderness; redness; lump on left leg; Superficial clo... Read more
2 weeks after vaccine noticed pain; Swelling; Tenderness; redness; lump on left leg; Superficial clot and other DVT clot found; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female consumer received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot ew0153 as single dose via unknown route at the left arm on 06Apr2021 11:30, at the age of 49 years, for COVID-19 immunization. The patient was not pregnant. Medical history included, in 1996 while on oral contraceptives had a blood clot in left leg. Prescribed Coumadin for year. Went off, bad leg swelling occurred. Prescribed compression stocking. Genetic test discovered Factor V Leiden mutation heterozygous. Since 1996-1998, have had bad swelling in left leg but no further clotting. Last time ultrasound was needed to confirm leg was just bad swelling was approximately 2007. No other clotting since around 1996-1998. Concomitant medications were not reported. On evening 20Apr2021, 2 weeks after vaccine, noticed pain, swelling, tenderness, redness and lump on left leg. Went to doctor on 21Apr2021. Ultrasound performed. Superficial clot and other DVT clot found. Prescribed Xarelto. The outcome of the events was reported as recovering. No covid prior vaccination and the patient was not tested for covid post vaccination.
49 2021-05-08 lymph node pain, lymph node swelling Painful, swollen lymph nodes in neck and armpit
49 2021-05-08 lymph node swelling I woke up with what at the time I assumed was a spider bite near my left armpit. Redness was diffuse... Read more
I woke up with what at the time I assumed was a spider bite near my left armpit. Redness was diffuse (could not see an actual ?bite? spot). Gradually got redder and larger and lymph nodes were swollen and very sore. This lasted about 7 days.
49 2021-05-08 swollen extremities 5/7/21 - 28 hours after shot-hives covering arms and legs-intense itch. Allegra taken and gone. 5/8/... Read more
5/7/21 - 28 hours after shot-hives covering arms and legs-intense itch. Allegra taken and gone. 5/8/21 - 6pm stomach and back covered with a sea of red skin. Arms, neck, legs, butt full hives. Intense itch and uncomfortable. Doctor told me to take Zyrtec twice a day for 3 days. Both days have swollen armpit, very uncomfortable.Took Advil.
49 2021-05-10 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: C... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Severe
49 2021-05-10 lymph node swelling, lymph node pain Swollen lymph nodes and it painful; Swollen lymph nodes and it painful; This is a spontaneous report... Read more
Swollen lymph nodes and it painful; Swollen lymph nodes and it painful; This is a spontaneous report from a contactable consumer reported for herself. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 11Apr2021 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number:ER8727) on 21March2021 Intramuscular, Right Arm for covid-19 immunisation. The patient experienced swollen lymph nodes and it painful (non-serious) on 11Apr2021 with outcome of not recovered. The patient took paracetamol (TYLENOL), 500mg, two times in a day for treatment. No follow-up attempts are needed. No further information is expected.
49 2021-05-10 lymph node swelling Swollen lymph node under armpit; fatigue
49 2021-05-10 peripheral swelling Pain on my armpit and my armpit is swollen; Pain on my armpit and my armpit is swollen; Headache; Ch... Read more
Pain on my armpit and my armpit is swollen; Pain on my armpit and my armpit is swollen; Headache; Chills; This is a spontaneous report from contactable consumer (patient). A 49-years-old female patient received second dose, via an unspecified route of administration (Batch/Lot number was not reported) on 25Apr2021 as Single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The historical vaccine included patients received first dose, via an unspecified route of administration (Batch/Lot number was not reported) on 03Apr2021 for covid-19 immunisation. The patient experienced chills and a little bit of a headache and started having pain on her armpit and her armpit was swollen in 2021. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
49 2021-05-11 lymph node pain Feeling inflammation in back, stomach, neck, lymph nodes aching/hurting and headache on left side al... Read more
Feeling inflammation in back, stomach, neck, lymph nodes aching/hurting and headache on left side all after 4 days to current.
49 2021-05-11 lymph node swelling was feeling some chest pain; she wakes up freezing; eyes felt really hot and dry; eyes felt really h... Read more
was feeling some chest pain; she wakes up freezing; eyes felt really hot and dry; eyes felt really hot and dry; slight fogginess; achiness; I tested positive for COVID; Restless body; Nausea; Weakness; Fast heartbeat; Headache; Chills; Muscle pain; Feeling unwell; high fever couldnt shake it at all; got congested/ Stuffy nose; facing joint ache; extremely tired/ Tiredness; Pain in arm/ whole hand just felt achy; Heart hurt when laying on side; Dizziness/ lightheadedness; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Apr2021 15:00 (Batch/Lot Number: EW0164) (at the age of 49 years old) at 1st dose, single for COVID-19 immunisation. Medical history included asthma and hypersensitivity (allergies). Concomitant medications included montelukast sodium (SINGULAIR) taken for hypersensitivity; formoterol fumarate, mometasone furoate (DULERA) taken for asthma; beclometasone dipropionate (QVAR); and levosalbutamol hydrochloride (XOPENEX). On unspecified date in Apr2021, she got pretty sick and swollen lymph nodes. On 23Apr2021, the patient experienced heart hurt when laying on side, high fever couldn't shake it at all, extremely tired/tiredness, headache, chills, muscle pain, feeling unwell, joint pain/ facing joint ache, dizziness/lightheadedness, fast heartbeat, pain in arm and got congested/ stuffy nose. On 24Apr2021, the patient experienced nausea and weakness. On 25Apr2021, the patient experienced restless body, her body also got extremely restless like she had restlessness lesions on whole body. On 26Apr2021, the patient tested positive for COVID-19. On unspecified date, the patient experienced chest pain, she wakes up freezing and her eyes felt really hot and dry and was exhausted, whole hand just felt super achy, slight fogginess and achiness. The patient had vaccination on Friday. On Friday night, she started not feeling well and then was like full blown all the Saturday all the Sunday (as reported). The patient got vaccination last Friday and had a severe reaction to the vaccination. She was extremely upset about it because now she tested positive for COVID. She was not really showing any symptoms and whatsoever before of any COVID like symptoms. Allergy was bothering her but no fever, no chills, no tiredness, no achiness and no nothing. She was nervous because she did realize that it wasn't FDA approved and now she was suffering positive, she started feeling a little better but still tested positive. It was reported that the event started at the time of report, 26Apr2021. The patient had a severe reaction. She had every symptom except that her arm didn't swell. She didn't have any rash in her body. She got pretty sick. She had a high fever couldn't shake it at all, got congested, facing joint ache and extremely tired. Her body also got extremely restless like she had restlessness lesions on whole body she couldn't lay down. The patient reported that it was hurting her so bad and she had to keep moving like she couldn't relax fall free. She had a severe reaction and doctor said she could have COVID knowing it and then got a shot and then came out full blown. The patient stated she was taking Tylenol (50mg, Not clarified), Tylenol Cold and sinus (325mg) for like a flu and Motrin (500mg). She had some time to shake the achiness and the fever was just coming back. She took Tylenol to help rid of fever and achiness, it didn't help and then she tried Tylenol cold and flu that help the little bit then she tried Motrin the Motrin help more with achiness but not hundred percent. The outcome of the events heart hurt when laying on side and fast heartbeat, both recovered on 26Apr2021; events high fever, tiredness, chills, muscle pain, feeling unwell, swollen lymph nodes and dizziness were recovering; events nausea, restless body and stuffy nose were not recovered; and unknown outcome for the other events. No follow-up attempts are needed. No further information is expected.
49 2021-05-12 lymph node swelling swollen lymph nodes left arm (resolved 6 weeks later), nerve pain left arm (resolved), headache (res... Read more
swollen lymph nodes left arm (resolved 6 weeks later), nerve pain left arm (resolved), headache (resolved), tingling in lips (resolved), numbness left side of face (continuing)
49 2021-05-12 oral herpes I developed a herpes sore on my top lip 2 weeks post injection for both doses. Treated topically at ... Read more
I developed a herpes sore on my top lip 2 weeks post injection for both doses. Treated topically at home with OTC Abreva cream, resolved about 1 week later. I also experienced oral discomfort on my hard palate and tongue about 24-48 following both injections. It was similar to a chemo side effect but not as severe, tenderness, kind of raw/burning sensation. Resolved on its own after several days
49 2021-05-12 swelling All over swelling, cough, severe pain in injected arm, headache, extreme fatigue (bedridden for the ... Read more
All over swelling, cough, severe pain in injected arm, headache, extreme fatigue (bedridden for the first day after the administration day). Still fatigued, cough is increasing
49 2021-05-13 lymph node swelling, lymph node pain Swelling and tenderness in limp node, same arm as shot was given
49 2021-05-13 swelling face After 8 days of receiving dose 1, I experienced swelling in my lips and face. It was not initially ... Read more
After 8 days of receiving dose 1, I experienced swelling in my lips and face. It was not initially correlated to the vaccine util the 2nd dose. After 4 hours of receiving the second dose I experienced swelling in the lips, face and tightness in throat.
49 2021-05-15 lymph node swelling, lymph node pain Very swollen and painful lymph nodes in left armpit (Same side as shot delivery)
49 2021-05-15 lymph node swelling Fever of 102 degrees, body aches, chills, fatigue began the following day and lasted 14 hours. Treat... Read more
Fever of 102 degrees, body aches, chills, fatigue began the following day and lasted 14 hours. Treated with over the counter pain reliever and sleep. 2 days after vaccine had swollen neck and lymph node on side of injection.
49 2021-05-17 lymph node swelling Lymph node swelling/ having lymph nodes on the left side of the back of her neck that were swollen; ... Read more
Lymph node swelling/ having lymph nodes on the left side of the back of her neck that were swollen; Fever; She felt really hot and sweaty for 2 days.; She felt really hot and sweaty for 2 days.; Muscle pain; She felt the pain in knees, hips, wrist, and elbows with second dose/Joint pain; She felt disabled like she can't move; Crazy fatigue; Joint pain had increased; Arm pain; Feeling like someone had punched her 10 times/ felt like someone punched her ten times at injection site; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 15Apr2021 13:30 (Batch/Lot Number: EL9262) as 2nd dose, single for covid-19 immunisation. Medical history included autoimmune disorder (ongoing), psoriatic arthropathy (ongoing), rheumatoid arthritis (ongoing), abdominal operation (appendix removed), Joint pain, anxiety, vitamin D deficiency, palpations, arrhythmias, hysterectomy and hypersensitivity (she has lots of allergies. anaphylaxis was a concern for her). Family history included her two sisters and mom had GI symptoms after the Covid19 vaccine. One of the two sisters works in healthcare. Concomitant medications included paracetamol (ACETAMINOPHEN) ongoing since unknown years at a dose of one 500 mg, ranges from 2 to 3 a day, liquid gel for arthralgia, hypersensitivity (she took it as she had to); atenolol tablet ongoing since at least 20 years at a dose of 100 mg oral, two times daily for palpitations, arrhythmia (she had lots of allergies and when she finds something that works, she leaves it alone); levothyroxine tablet ongoing since 10-15 years at a dose of 0.05 mg oral once daily for thyroid hormone replacement therapy; alprazolam tablet ongoing since at least 20 years at a dose of 1 mg oral 3-4 times a day for anxiety; vitamin D Nos ongoing since an unknown date at a dose of 50 mcg, softgel, once a day for vitamin d deficiency (If the deficiency goes lower her doctor would have her take two but right now she takes one). No other vaccine in four weeks. The patient previously took first dose of bnt162b2 in left arm (Lot number:ER8732) on 25Mar2021 at 14:30 for covid-19 immunisation and had experienced dizziness, vaccination site pain, hyperpyrexia, fatigue, pyrexia, myalgia, condition aggravated, pain in extremity, hyperhidrosis, feeling hot and took flu shot made her unconscious. It was reported that, patient was reporting on herself and had a question. She got the first vaccine on 25MAR2021. She had the second dose on 15APR2021. She asked the doctor about it because she does have several autoimmune issues. She mentioned she had gotten a flu shot in the past but the flu shot made her unconscious. It had no after effect, and it did not do anything. She had not received the flu shot in the last 20 years and had not gotten the flu either. For the flu shot she didn't have the Lot, NDC or EXP. At that time, she was working in healthcare and made everyone do it. It was a fluke and no after-effects. She also mentioned she had lots of allergies. Anaphylaxis was a concern for her. With the first shot, she couldn't describe it, but first 10 to 15 seconds less than a minute started feeling dizzy but not really, states it was like when you first wake up from surgery where you are confused. It was an odd sensation. Then it went away. She didn't think much about it. She didn't even feel the needle prick then half hour later it felt like someone punched her 10 times, which lasted for two or three days. She decided to sit extra time in the waiting room area. She later confirmed later that this was regarding the Pfizer Covid Vaccine. She mentioned that she takes Tylenol on a daily basis but did not take it the day she got the vaccine. She went on to explain that she had a list of what to expect but the first dose it wasn't that bad. Within 8 hours of both vaccines experienced crazy fatigue and was so tired. She has joint pain normally and was in a flare due to psoriatic and rheumatoid arthritis but after the vaccines the joint pain had increased. After a couple of days, it went back to how her pain normally was. Her main issue was with the second vaccine. The second shot on 15APR2021 did expect it to be worst. Dizzy: It went away. It was less than a minute and then it was gone. It happened while she was sitting in the seat. It was so strong and then it went away in a minute, it was gone. She felt like someone punched her ten times at the injection site: occurred with both doses, the first time it occurred starting 25MAR2021 She didn't even feel the needle prick, the injection itself did not hurt, then it felt like someone punched her hard 10 times. This started 20 to 30 minutes after getting the vaccine. When she got home no redness or really even swelling. Later confirmed no swelling. She had arm pain that lasted for 2-3 days and then it went away. The same thing occurred with the second dose on 15APR2021. Then it resolved on its own. She used icepack as a treatment. it did not kill the pain but made it more tolerable. She was just more sensitive. She confirmed that she recovered completely from the feeling like someone had punched her 10 times from both the first and second dose. Fatigue: It started 8 hours after vaccine on both 25Mar2021 and 15Apr2021. She thought she was home free. It was weird. She also mentioned with fatigue she started having a fever, muscle pain, and horrible joint pain all at the same time. They lasted 2-3 days and then she recovered completely. Fever: Started 25MAR2021 after the first vaccine and then started again on 15 APR 2021 after the second vaccine. She felt really hot and sweaty for 2 days. She said she does not feel get fevers very often. She had it 8 hours after both injections she wasn't sure why it took 8 hours. The first-time highest temperature about 101. Both times she took Tylenol every 6 hours for two days and as soon as the Tylenol wore off the fever would come back but the temperature would be lower. She confirmed she recovered completely after both occurrences. Caller initially stated she was taking Tylenol and then later clarified she was taking CVS brand acetaminophen. She mentioned she takes this one because she had a lot of allergies and cannot take the regular Tylenol brand due to the fillers in it, Tylenol bothers her. Caller referred to CVS acetaminophen as Tylenol throughout the report and then clarified at the end. Tylenol clarified as CVS brand acetaminophen. Did not had lot number, expiration, NDC. The lot number and expiration date are rubbed off the bottle and she cannot read them, there is a black smear where it says lot/exp. Muscle pain: Hit all at once and lasted 2 days for both vaccine doses. She recovered completely from both occurrences. and started within 8 hours for both doses. Joint pain: It started within the same time. Within 8 hours of both doses. She had joint pain every day but it amplified after vaccine doses. She felt disabled like she can't move. There was a difference. First time mostly was in her knees and hips. The second time it seemed to last longer, it aggravated the flare already there. She felt the pain in knees, hips, wrist, and elbows with second dose. States the wrist joint pain was really bad and she sometimes gets that with her rheumatoid arthritis but she was not having pain in arms, in her wrists and elbows before the injection. She has pain now but its the normal pain that she had felt prior to the injection. Lymph Node swelling: on saturday the 17APR2021 noticed her lymph nodes were swelling. She had a mammogram appointment. It was located under her left armpit. She called your doctor next day on the 18th because it was getting more painful. She was also having lymph nodes on the left side of the back of her neck that were swollen. That was part of the reason that she was calling because she wanted to see if that was normal. The lymph nodes swelling are all still there and they hurt. When probed for outcome caller did not clearly provide. She just mentioned that she was aware that it could happen under the armpit and figured that it would go away. But then she got one on the back of her neck which is also on the left side. She knows overtime that side effects have been added to our list. The doctors said if its persisting longer to call back and come in. Asked if it was normal. She did not have a cold or anything that would be causing it. she thought that the shingles vaccine was due next for her since she would turn 50, but she did not think she would get that. Treatment was received for events. The outcome of event lymphadenopathy was not recovered, whereas recovered for all other events. Description of Product Complaint: Description of complaint: While reporting on the Covid 19 vaccine caller mentioned details on other products. She first mentioned details about the flu shot. She mentioned she has gotten a flu shot in the past, but the flu shot made her unconscious. It had no after effect. She has not received the flu shot in the last 20 years and has not gotten the flu either. For the flu shot she doesn't have the Lot #, NDC or EXP. She also mentioned details about Tylenol clarified as CVS brand acetaminophen. She took Tylenol every 6 hours and as soon as the Tylenol wore off the fever would come back but the temperature would be lower. Did not have lot number, expiration, NDC. The lot number and expiration date are rubbed off the bottle and she cannot read them, there is a black smear where it says lot/exp. She mentioned she taken this one because she has a lot of allergies and cannot take the regular Tylenol brand due to the fillers in it, it bothers her. No follow-up attempts are needed. No further information is expected.
49 2021-05-17 swelling Eczema side of mouth; Inflammation size of baseball under right armpit; Inflammation size of basebal... Read more
Eczema side of mouth; Inflammation size of baseball under right armpit; Inflammation size of baseball under right armpit; This is a spontaneous report from a contactable reporter. A 49-year-old non pregnant female nurse reported for herself that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and expiry date: UNKNOWN), via an unspecified route of administration at right arm on 27Jan2021 07:00 at hospital as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination the patient did not receive any other vaccines within 4 weeks and did not received any other medications with in two weeks of vaccination. On an unspecified date in Jan2021 patient experienced Eczema side of mouth after first dose of vaccine, Inflammation size of baseball under right armpit, Same arm as vaccine. The patient did not receive any treatment for the events. Patient visited doctor or other healthcare professional office/clinic visit due to events. The outcome of the events Eczema side of mouth and Inflammation size of baseball under right armpit were not recovered. Follow-up attempts have been completed and no further information is expected.
49 2021-05-18 swelling face Face got very red; Face got very red, hot; Face got slightly swollen; Face got very red, hot and spl... Read more
Face got very red; Face got very red, hot; Face got slightly swollen; Face got very red, hot and splotchy; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 05Mar2021 at 09:30 (at the age of 49-years-old), as a first single dose for COVID-19 immunisation. The patient's medical history included asthma. The patient had previously experienced allergy when receiving Zithromax (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 05Mar2021 at 09:45, the patient's face got very red, hot and splotchy and was slightly swollen. The patient did not receive any treatment for the adverse events. The clinical outcome of face got very red, hot and splotchy and slightly swollen was recovered. No follow-up attempts are needed. No further information is expected.
49 2021-05-19 anaphylactic reaction I am anaphylactic survivor. I felt it instantly after the shot: pain up my neck, left side of my ba... Read more
I am anaphylactic survivor. I felt it instantly after the shot: pain up my neck, left side of my back & shoulders, then few minutes later metallic taste in mouth, then nose was stinging, then runny nose and then a few mins later shortness of breath. Told my family about it and they said it was probably side affect, minor/seasonal allergies and that I could take Claritin-D 24-hr. It appeared to have minimized the shortness of breath, which comes & goes every few (15 or 30) mins, but still runny nose. I took for 3 days. When I stopped taking Claritin-D 24-hr on Wed in the AM, in the afternoon, started to have difficulty breathing and runny nose. But it was stronger, shallow breathing. So I took Claritin-D 24-hr again but it wasn't working that well, so, took Benedryl at night as well. Then I took an additional Benedryl. I still have the symptoms but manageable with the allergy meds.
49 2021-05-22 swelling face 1. Hives: Noticed 12-20 hours after vaccination (early next morning). Developed itchy, red welts ... Read more
1. Hives: Noticed 12-20 hours after vaccination (early next morning). Developed itchy, red welts on neck, abdomen, upper legs, back. Lasted for 7 days. 2. Light-headed, dizziness, loss of balance: Within 3-5 hours of vaccination. Lasted 3 days. 3. Facial swelling: Noticed 12-20 hours after vaccination (next morning on waking). Lasted 5-7 days. 4. Fatigue: Started within 3-5 hours and lasted 3-5 days. 5. Headache: Within 3-5 hours; Lasted 3 days; Ibuprofen started 24 hours after vaccination and taken for 3 days 6. Injection site pain: Within 1-2 hours and worsened over 24 hours. Lasted 7 days; Ibuprofen started 24 hours after vaccination and taken for 3 days.
49 2021-05-23 lymph node swelling body aches, temp of 101 even while alternating advil and tylenol, swollen lymph nodes, red painful ... Read more
body aches, temp of 101 even while alternating advil and tylenol, swollen lymph nodes, red painful swollen rash on arm that burns and itches
49 2021-05-23 lymph node swelling Soreness at injection site after first and second doses for a few days. Soreness in left armpit (s... Read more
Soreness at injection site after first and second doses for a few days. Soreness in left armpit (swollen lymph nodes) after first dose for a few days. Tingling/burning/chilling sensation in feet (almost constant from onset till time of reporting - 10 days), sometimes also in legs and arms, and once in scalp. Rash at injection site two days after second dose (05/21/2021), still present at time of reporting. Swollen lymph node near left clavicle two days after second dose, still present at time of reporting. Swollen
49 2021-05-23 peripheral swelling There were not adverse events at the time the shot was administered. I started displaying symptoms ... Read more
There were not adverse events at the time the shot was administered. I started displaying symptoms on or around May 10th with tingling in fingertips that I couldn't pin point and joint pain in my left hand below my knuckles (palm side). Around May 17th, I got swelling in my feet (I took photos) and May 18th, I started to feel itching on the back of my left thigh with no symptoms of a rash. I woke up on May 19th with what looked like ant bites but by the 20th, I couldn't touch it. I went to urgent care on May 21st and was diagnosed with shingles.
49 2021-05-23 peripheral swelling Pfizer-BioNTech COVID-19 Vaccine EUA: during follow-up encounter with allergy clinic patient reports... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: during follow-up encounter with allergy clinic patient reports metallic taste within thirty minutes of vaccination. Two hours later developed headache and fatigue. Two days later developed lower extremity swelling, low heart rate (52 beats per minute), blister on neck/upper back, leg pain, neuropathy, and left arm bruising where immunized. Six weeks later symptoms are beginning to resolve. Patient advised to continue current medications for reaction.
49 2021-05-24 peripheral swelling Initially in the first 24 hours my arm became very swollen and hot and sore to touch. Gradually ove... Read more
Initially in the first 24 hours my arm became very swollen and hot and sore to touch. Gradually over the next few weeks I began to have weakness with numbness and tingling accompanied by hypersensitivity to touch. Increasingly unable to use my left arm to hold anything, steer the car, hook my bra, sleep on my left side...The pain gradually increased and radiated from the insertion of the deltoid up into my shoulder and down into my elbow. I tried bracing, I tried, cold packs, heat packs, tens unit, lymph drainage, and exercises. While I did not get any pain relief or return of strength with any of the above methods I did prevent loss of motion. At 8 wks post injection with no improvement and continued loss of f
49 2021-05-24 swelling face, swelling hives and swelling (whole body including mouth, tongue, face)
49 2021-05-24 swelling I had high fever for about 16 hours. Felt like vomiting, dehydration, blood pressure was very high, ... Read more
I had high fever for about 16 hours. Felt like vomiting, dehydration, blood pressure was very high, heartrate was very high and continues headache. After about 16 hours I ended up going to the Emergency Room. I was treated for high blood pressure, high heartrate, fever, dehydration and headache. I have never experience all of these symptoms at one time in my life. It was a very expensive experience for me. I was fine Thursdays all day until I got the vaccine, A few minutes after I got the Vaccine I felt a little bump on my forehead. I am usually very sensitive to a lot of things so i assumed it was noting. The actual fever didn't occur until 5 am in the morning. I know this experience is better than getting the actual COVID I just thought I would share my situation.
49 2021-05-24 swelling Lump in left neck - Ultrasound and MRI completed radiology reports shows inflammation, infection or ... Read more
Lump in left neck - Ultrasound and MRI completed radiology reports shows inflammation, infection or neoplastic Extreme fatigue Unexplained weight loss Achy spine Joint pain in elbows, knees, neck, shoulders Itchy Bruising Late period Brain fog Coordination/stability issues Sore Throat Headaches Night Sweats
49 2021-05-25 swelling face I had swelling on my forehead, between my eyebrows, down the bridge of my nose, and, both sides of ... Read more
I had swelling on my forehead, between my eyebrows, down the bridge of my nose, and, both sides of the bridge of my nose.; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 12Jan2021 09:30 (Batch/Lot Number: EJ1686) (at the age of 49 years old) as 1st dose, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included penicillin allergy. No other vaccine in four weeks and no other medications in two weeks. The patient experienced swelling on forehead between eyebrows, down the bridge of my nose, and both sides of the bridge of my nose on 13Jan2021 06:30. No treatment for the event. No COVID prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab: negative on 12Feb2021. The outcome of the event was recovered on unspecified date. Follow-up attempts are completed. No further information is expected.
49 2021-05-27 white blood cell count increased 49 y/o female without significant PMH other than anaphylaxis from a dental procedure, who presents ... Read more
49 y/o female without significant PMH other than anaphylaxis from a dental procedure, who presents to the emergency room with multiple complaints after receiving her second SARS-CoV-2 Pfizer vaccination today at about 3-3:30 PM, lot number not current available. The patient's significant other/boyfriend was driving when he noticed the patient suddenly started to complain of shortness of breath with chest pain and a maculopapular rash which later was followed by expressive aphasia and left hemiparalysis. She received Pepcid, solumedrol and Benadryl for the rash in the ER with improvement. Code neuro was called and TPA was given. Post TPA she was alert and oriented and she could currently write with her right hand and think of the words she has to say. She had associated blurry vision which has resolved after TPA was administered. She also was not able to move her left lower extremity nor her left upper extremity which is also improving to some extent after TPA administration. So far CT/CTA head and CTA neck are negative and she has been admitted for likely acute cerebral vascular accident.
49 2021-05-28 lymph node swelling Full Body Aches; Freezing Chills; Headache; Frequent Urination; Constant Yawning; Swollen Lymph Node... Read more
Full Body Aches; Freezing Chills; Headache; Frequent Urination; Constant Yawning; Swollen Lymph Node In Injection Arm; Fatigue; This is a spontaneous report from a contactable Other Health Care Professional, reporting for a 49-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262, Expiration date: unknown), via intramuscular, administered in left arm on 26Jan2021 at 16:45 (at the age of 49-year-old) as 2nd dose, single for COVID-19 immunization. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EJ1686) intramuscularly in left arm on 05jan2021.The patient medical history includes diabetes mellitus, obesity and smoker and concomitant medications include Metformin, Glipizide, Atorvastatin, Amlodipine, Omeprazole, Vitamin D, Fish Oil, Baby Aspirin. The patient had history of lisinopril allergy. Patient was not tested Covid-19 positive prior vaccination. On 27jan2021, 15hours 30 minutes after the vaccination, the patient experienced Full Body Aches, Freezing Chills, Headache, Frequent Urination, Constant Yawning, Swollen Lymph Node in Injection Arm, Fatigue. The reporter assessed all events as non-serious. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.
49 2021-05-30 peripheral swelling It felt weird from the get go. I felt it go into my arm. That night I could barely move my left arm.... Read more
It felt weird from the get go. I felt it go into my arm. That night I could barely move my left arm. It got better, but in the days that followed I got a pain in my neck and shoulder. I thought maybe I slept wrong. I ended up going to a physical therapist, a massage therapist, and a chiropractor to get some relief. I had some numbness and tingling down the left side of my arm with my ring finger and my pinky. I got no relief from that. I went to my doctor and he found a knot under my arm. I thought the swelling from that might have hit a nerve. My PCP sent me to another doctor, who is a surgeon. He ordered an ultrasound. When that came back, it came back as a swollen lymph node. I went and had a biopsy done. When it came back everything looked good. Last week, I was taking off my dress and I was like "oh that hurts!". The lump under my arm was bigger and was hurting. I am having another ultrasound done Friday. It is still swollen and it has been like this since a few days after Jan 6 2021.
49 2021-05-31 lymph node swelling Swollen lymph nodes in right under arm (armpit), back of neck right side, front of neck under chin r... Read more
Swollen lymph nodes in right under arm (armpit), back of neck right side, front of neck under chin right side. Duration lasted for 8-10 days.
49 2021-05-31 peripheral swelling Injection site has bruise; swelling in upper arm; redness appeared at base of swelling about 4 inche... Read more
Injection site has bruise; swelling in upper arm; redness appeared at base of swelling about 4 inches below injection; injection site tender; injection site is swollen; This is a spontaneous report from a contactable consumer (patient). A 49-years-old non-pregnant female patient received second dose BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot/batch no: EN6208) as a single dose on an unspecified route of administrated in right arm on 12Mar2021 at 12:30 PM for COVID-19 vaccination. Medical history included diabetes and Polycystic ovary syndrome (PCOS). The patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot/batch no: EN6201) as a single dose on an unspecified route of administrated in right arm on 19Feb2021 at 12:15 PM for COVID-19 vaccination. Concomitant medication includes atenolol (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), spironolactone l(MANUFACTURER UNKNOWN), humalog (MANUFACTURER UNKNOWN) and lant(MANUFACTURER UNKNOWN). Patient was allergic to penicilin, vicodin, moraphine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 13Mar2021 patient experienced Injection site has bruise, swelling in upper arm, redness appeared at base of swelling about 4 inches below injection site, injection site was swollen and tender. The patient reported that Injection site has bruise. Day two noticed swelling in upper arm. Day three redness appeared at base of swelling about 4 inches below injection site. Day 4 redness has more than doubled and tenderness has increased at the area of redness. The entire upper arm below injection site was swollen and tender. The events resulted in Doctor or other healthcare professional office/clinic visit, however it was unknown if treatment received for the adverse event. The clinical outcomes for Injection site has bruise, swelling in upper arm, redness appeared at base of swelling about 4 inches below injection site, injection site is swollen and tender was Not recovered. No follow-up attempts are needed. No further information is expected.
49 2021-05-31 swelling face Herpes Zoster Ophthalmicus (HZO); onset of symptoms 05/02/2021, including painful rash, blisters, fa... Read more
Herpes Zoster Ophthalmicus (HZO); onset of symptoms 05/02/2021, including painful rash, blisters, fatigue, headache, shooting and buring pain, swollen rash along forehead and over left eye.
49 2021-05-31 white blood cell count increased broke out in rash from head to toe, sores everywhere, high bp
49 2021-06-01 swelling face Why was the patient taking Covid-19 vaccine (Verbatim): because she is diabetic; swelling under eyel... Read more
Why was the patient taking Covid-19 vaccine (Verbatim): because she is diabetic; swelling under eyelids; swelling on chin and left cheek; had an allergic reaction with a rash; rash from neck up on chin and cheeks; This is a spontaneous report from a contactable reporter(patient herself). A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0176) via an unspecified route of administration, administered in right arm on 29Apr2021 at 14:30 as single dose for COVID-19 immunization. Other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. AE(s) following prior vaccinations was reported as none. Medical history included type 2 diabetes mellitus. It was reported that she ran out of medication and was not taking anything for diabetes. Family Medical History Relevant to AE(s) included that her father had a positive result after getting the vaccine. Her father has rheumatoid arthritis including pain all over. After getting the vaccine, the pain went away. Her father also had a rash on his arm that cleared up after getting the vaccine. No relevant tests were done as reported. Concomitant medication included Azo from 27 Apr 2021, ongoing and Nervive taken for nerve relief from 27 Apr 2021 and stopped taking it on 03 May 2021. It was reported that she was fine but had an allergic reaction with a rash from her neck up that was on her chin and cheeks around 1700-1800 on 29Apr2021. She had swelling under her eyelids on 30Apr2021 and on the bottom of her cheek on 30Apr2021. It was also reported that the patient took Covid-19 vaccine because she is diabetic. She was scheduled to get the second injection today(20May2021) and was asking if she should get it. She mentioned that she does not have a physician. She thought she had a reaction to it. Lot 1069C95021, Expiry Feb 2023.. The outcome of the events, off label use was unknown and rash from neck up on chin and cheeks and swelling on chin and left cheek was recovered on 11May2021, rash from neck up on chin and cheeks was recovered on 03May2021. Follow up attempts are needed. Further information has been requested.
49 2021-06-03 lymph node swelling, lymph node pain I received my 1st vaccine on Friday May 14 and I felt worse than when I had Covid back in November... Read more
I received my 1st vaccine on Friday May 14 and I felt worse than when I had Covid back in November. My fever was spiking and holding between 100 and 101 since Saturday along with my whole body hurt and armpits swollen-lymph nodes. Monday my stomach started hurting and had diarrhea Fever was back to 99 but still felt icky tired weird until Tuesday. Wednesday May 19th I felt a lot better but still not 100% still feeling a bit weird head feels weird and my lymph nodes are still a little enlarged( armpit also) Had about a week of not feeling bad and then May 27th I got a sore throat headache stuffed up tired.. by Wednesday June 2nd my neck lymph nodes was swollen and sore went in for strep/Covid test both negative . They gave me a antibiotic it?s helping a little throat not as sore and lymph not as swollen But my head still feels weird (kinda dizzy and off) like after my shot so I don?t k is if it is another flare up from the vaccine or not and I was supposed to get my second dose today June 4 but I canceled and rescheduled it but I?m nervous to get it in case all of this is from the initial shot
49 2021-06-03 lymph node swelling Swollen lymph node-left armpit; Swollen lymph node-left armpit. Verysore and achy.; Very sore and ac... Read more
Swollen lymph node-left armpit; Swollen lymph node-left armpit. Verysore and achy.; Very sore and achy; This is a spontaneous report from a contactable consumer, the patient. A 49-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Ep7534) via an unspecified route of administration in the left arm on 15Mar2021 at 10:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included Synthroid for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 17Mar2021 at 08:00, the patient had experienced swollen lymph node-left armpit, armpit pain and ache. The clinical outcome of the swollen lymph node, armpit pain and ache was not resolved. No follow-up attempts are needed. No further information is expected.
49 2021-06-03 oral herpes, peripheral swelling After the second vaccination have/had severe right arm swelling (still icing arm) entire upper arm s... Read more
After the second vaccination have/had severe right arm swelling (still icing arm) entire upper arm swollen no redness; hot to touch; Fever; chills; cold sore upper lip; This is a spontaneous report from a contactable other hcp. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN6198), dose 2 via an unspecified route of administration, administered in Arm Right on 03Mar2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Patient had previously received first dose of vaccine (Lot number: EM9809) in left arm on 10Feb2021 at 12:30. Patient did not receive other vaccine in four weeks of vaccination.Patient has not been tested for COVID, post vaccination. The patient's concomitant medications were not reported. On 03Mar2021, patient experienced severe right arm swelling (still icing arm) entire upper arm swollen no redness, hot to touch, fever, chills the next day lasting 2 days. Also now have a cold sore upper lip after the vaccination. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of after the second vaccination have/had severe right arm swelling (still icing arm) entire upper arm swollen no redness, hot to touch, fever, chills, cold sore upper lip. The outcome of all events was recovering. No follow-up attempts are possible. No further information is expected.
49 2021-06-07 peripheral swelling 7 days after first vaccine left arm developed hives and severe itching. 10 days after first dose Le... Read more
7 days after first vaccine left arm developed hives and severe itching. 10 days after first dose Left hand developed clear white itchy rash. 18 days after first vaccine SEVERE swelling in right left and knee as well as severe cramping in calf muscle. OTC meds, ice and heat...nothing helps. Can not put pressure on that leg at all.
49 2021-06-08 swelling face I was very tired for several days. My eyes and face were swollen for over a week. My arm has been r... Read more
I was very tired for several days. My eyes and face were swollen for over a week. My arm has been red and tender with a hard long lump to the right of the injection site for almost two weeks since the vaccination.
49 2021-06-11 lymph node swelling I have a itchy golf ball size swollen lymph node under the arm pit of the are I got my vaccine. 1st ... Read more
I have a itchy golf ball size swollen lymph node under the arm pit of the are I got my vaccine. 1st dose
49 2021-06-14 anaphylactic reaction After 10 hours of 2nd dose, I experienced anaphylaxis - rash all over my entire body, nausea, low bl... Read more
After 10 hours of 2nd dose, I experienced anaphylaxis - rash all over my entire body, nausea, low blood pressure and my body was shaking from being so cold even though I felt like I was on fire from the inside.
49 2021-06-15 anaphylactic reaction flushing, difficulty breathing, rapid heart pulse (146), elevated blood pressure (183/103). Last an... Read more
flushing, difficulty breathing, rapid heart pulse (146), elevated blood pressure (183/103). Last anaphylaxis 8 years ago with allergy shot; received 2 epi-pens. Fortunately, 2nd dose was done at the Urgent care setting.
49 2021-06-16 lymph node pain I am getting the sharp dull, it's a mixed feeling thing; It is dull, dark, and very deep into my bon... Read more
I am getting the sharp dull, it's a mixed feeling thing; It is dull, dark, and very deep into my bone it feels; Itching; Lymph nodes do not hurt as much as they did; Fever; Headache; This travelling pain; Its very weird, sort of maybe in my calf, or in my thigh or arm; Dizziness; This is a spontaneous report via Pfizer Sponsored Program. A contactable consumer (patient) reported a 49-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch Number: EW0186), intramuscular on 25May2021 (at an age of 49-years-old) as 2nd dose, single dose for covid-19 immunization. The patient's medical history included hashimoto's thyroiditis, pernicious anemia, from an unspecified date in 2002 and anxiety from an unspecified date. The patient's concomitant medication included Levothyroxine (MANUFACTUERER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose once a day for autoimmune thyroiditis; Vitamin d3 (VITAMIN D3), (MANUFACTUERER UNKNOWN), via an unspecified route of administration on an unspecified date at 1000 IU daily for pernicious anaemia (When probed for the treatment of Pernicious Anemia, Consumer stated, "Actually, I just received high levels of Vitamin D tablets. Like 50,000 units per week and then another 25 units each day. It is over the counter this time but it is Vitamin D3. So I take 1000 units per day. Yeah each day and then 50,000 units per week."); Escitalopram oxalate (LEXAPRO) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at two and a half tablets once a day for anxiety. On an unspecified date. The patient previously took first dose of bnt162b2 on 22Apr2021 (Batch/Lot Number: EW0169) for covid-19 immunization. On 26May2021, the patient experienced dizziness. On an unspecified date, the patient experienced I am getting the sharp dull, it's a mixed feeling thing, it is dull, dark, and very deep into my bone it feels, itching, lymph nodes do not hurt as much as they did, fever, headache, this travelling pain, its very weird, sort of maybe in my calf, or in my thigh or arm. The patient experienced with ongoing side effects it was been a little over a week since the vaccination patient had lot of itching with dizziness continuing and patient was getting the sharp dull, it was a mixed feeling thing. So, it was dull, dark, and very deep into my bone it felt. The patient reported that the only thing that improved was her Lymph nodes do not hurt as much as they did. But patient was still having the extreme dizziness, the fever, headaches, and this travelling pain that patient could not explain very well. When confirmed if the anatomical site of second shot was same for both shots, Consumer stated, "Yes I did and then the second shot, I had a lot of itching with it. Very very dizzy. Still very dizzy." It was very weird, sort of maybe in her calf, or in her thigh or arm. The pain that really hurt, they were instant. So, they did not stay long but it kind of took her breath away because hurt so bad but then it disappeared. The patient took Tylenol 500 mg to try and get my temperature down. It did not help with the dizziness and it did not help with these shocking pains and mixed Tylenol with 600 milligrams of Ibuprofen. The seriousness of the events was unspecified. The clinical outcome of the lymph nodes do not hurt as much as they did was recovering and for the dizziness, I am getting the sharp dull, it's a mixed feeling thing, it is dull, dark, and very deep into my bone it feels, itching, fever, headache, this travelling pain, its very weird, sort of maybe in my calf, or in my thigh or arm were not recovered. Further information is requested.
49 2021-06-16 lymph node swelling popping jags in my throat swollen lymph node on my larynx Treatment: albuterol inhaler
49 2021-06-16 lymph node swelling Patient experiencing swelling on left supraclavicular area. Patient denies any other symptoms at thi... Read more
Patient experiencing swelling on left supraclavicular area. Patient denies any other symptoms at this time.
49 2021-06-16 peripheral swelling Evening of 3/6, there was a little dull ache in my knees. I drove for vaccine and drove back3/7. Ev... Read more
Evening of 3/6, there was a little dull ache in my knees. I drove for vaccine and drove back3/7. Evening of 3/7, I noticed dull ache was more pronounced. After I showered, I noticed back of both knees were swollen. I saw my PCP and she said it was probably a Baker's cyst. After a week or so, I went back to PCP since swelling didn't go down. I had Ultrasound done and no baker's cyst was found and no blood clots. I had a CBC done and it was normal. I also saw an Ortho doc- ruled out Lupus, RA, Osteoarthritis. I didn't do any strenuous activities to pull something. I went through physical therapy, but I was still sore and knees got swollen in front top part of knee. They said I had to build up strength in my quads/hams to support my knee. PT place I went to overworked me with heavy weights. I then had MRI done and they found some chondromalacia and patellofemoral syndrome. I was switched to a different PT and it's working better but still dealing with swollen knees and upper thighs seems swollen too - not sure if that is related to my workouts and building muscles back. I have spend a lot of money and time seeing various doctors/specialists to figure out what is happening. It is very frustrating and a big part of me wished I did not get the vaccine as I was being extremely cautious with going out in public. My family and I didn't interact much with others and always distanced ourselves and wore masks indoors and sometimes outdoors if to close in proximity to people. I am reluctant to give my 13 year old son the vaccine as he has some of my genetics.
49 2021-06-17 anaphylactic reaction 15 minutes after vaccination patient complained of arm tingling and numbness as she attempted to che... Read more
15 minutes after vaccination patient complained of arm tingling and numbness as she attempted to check out. we asked her to stay a few more minutes to make sure she felt ok. she sat back down and started coughing. we asked her to take her mask off so she could breathe easier. she started to wheeze. we asked about previous allergies and she confirmed that she had anaphylaxis to 2 different vaccines (tetanus and MMR). we monitored her breathing which became more labored. she started to lose consciousness. we administered an epi-pen in the right thigh. within seconds her breathing relaxed. we called for the emergency department. they came and transported her to the ED for further evaluation. she was treated with antihistamines and solu-medrol and then released.
49 2021-06-17 lymph node swelling Large knot/lump in armpit of my left arm. Where my lymph node is located. Severe fever, chills and ... Read more
Large knot/lump in armpit of my left arm. Where my lymph node is located. Severe fever, chills and Migraine
49 2021-06-17 swelling Sore throat; ear fullness and discomfort/ear fullness in both ears; Headache; some uncomfortable swe... Read more
Sore throat; ear fullness and discomfort/ear fullness in both ears; Headache; some uncomfortable swelling on the side of the neck; Nausea; lower abdominal cramps; does not feel well/not feeling well; discomfort both sides of the neck; abdominal discomfort; has not been able to work since that time; This is a spontaneous report from a contactable physician. A 49-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Batch/Lot number was not reported), dose 1 intramuscular on 13Jan2021 as SINGLE DOSE for an COVID-19 Immunization. The patient medical history were not reported. The concomitant medications included ZITHROMAX, AUGMENTIN for upper respiratory bacterial infection and two drugs did not work. The patient experienced stated that he was calling on behalf of his wife that received the Pfizer Covid-19 Vaccine. The caller reported that his wife is a frontline worker and almost 3 weeks ago to the day on the 13Jan2021, she had the first dose that was organized through her work. She was fine until a week later on 20Jan2021 she experienced sore throat, ear fullness and discomfort in the ear, headache, and some uncomfortable swelling on the side of the neck. He said that she also experienced nausea and lower abdominal cramps. She did not feel well. And also reported discomfort both sides of the neck, abdominal discomfort. She has been the same way ever since and has not been able to work since that time. She is at the end of her Covid related leave that her work provides. He said that there was no fever, chills, shortness of breath, or cough. She has had several Covid PCR tests that have all been negative during that time period. She has not had Covid and has not been exposed to anyone with Covid. He said that because of her work she gets the seasonal flu shot. He said that she has not had a flu shot this year. In the past with flu shots, she gets the flu like symptoms. Caller said that she has no history of anaphylaxis or allergies otherwise. Stated that she is a physiotherapist and physiotherapy supervisor. Stated that they had arraigned the vaccine at work because she is an essential worker. Stated that they have spoke with an ear, nose throat specialist who thought this was a post vaccine reaction. Stated that they will be seeing an immunologist. Stated that she has insurance and is a high deductible. Wanted financial assistance for medical treatment starting up. Wanted help with the work situation because she has been off work for two weeks and will stay off work until this is resolved. Stated that he read online that Pfizer has a medical support fund. Stated that she has had repeated Covid RNA blood tests that are negative. Stated that she has not had history of allergies. Stated that she was treated with antibiotics that did not do anything. Stated that she saw her private primary care doctor on 27Jan. Stated that they can provide medical reports as far as correlation between the vaccine and the illness. Later clarified that the neck fullness is on both sides of the neck. Later clarified that she is experiencing ear fullness in both ears. The clinical outcome of the events were not recovered and the outcome of the events headache, nausea, lower abdominal cramps, has not been able to work since that time were unknown. Information on the Lot/batch number has been requested. Follow-up (03Feb2021): This is a follow up spontaneous report from a contactable physician. This physician reported for a patient (wife) that: Event onset date was updated. Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
49 2021-06-21 lymph node swelling The next day, I found a swollen lymph node above the left supraclavicular bone. (Testing showed I ha... Read more
The next day, I found a swollen lymph node above the left supraclavicular bone. (Testing showed I have two the larger is 1.5 x 1.0 x 1.7 cm and it has a thickened cortex.) It's still present. Not painful. It's quite prominent right now and yesterday I thought it was gone. So maybe that is because of the site of where it's at. It got measured by my regular doctor. I've had multiple doctor visits. I went to a specialist who did an ultrasound on June 11th. I have not had bowel symptoms. Have an appt with a general surgeon to have it checked on July 7th.
49 2021-06-22 peripheral swelling Within 5 minutes of injection, I started feeling faint and light headed, my skin was bright red with... Read more
Within 5 minutes of injection, I started feeling faint and light headed, my skin was bright red with a rash that was burning and itching. My throat and tongue were swelling. I also had tightness in my chest and difficulty breathing. At the vaccination site I was given Benadryl and about 10 minutes after that, they administered an Epi-pen. I was taken to the hospital and was treated with Mythlprednisolone sod suc (Soul-Medrol) and Famotidine. I was given an RX of Benadryl and Prednisone (Deltasone) that I took for the next week. For a couple weeks, I continued to have a rash and itchy skin and severe swelling of ankles and feet. On 4/22/21, I believe I was diagnosed with another reaction from the vaccine, Pericarditis. I spent 3 days in the hospital and I'm still taking Colchicine and Indomethcin from this event. I have been told I can not take the second dose of the vaccine at this time, but look back into this after September. I am also taking Alvesco and Combivent.
49 2021-06-22 swelling face, peripheral swelling Sudden unexplained 20 pound weight gain in one week. Difficulty breathing, walking and sleeping. Low... Read more
Sudden unexplained 20 pound weight gain in one week. Difficulty breathing, walking and sleeping. Lower leg, face and hand/arm swelling. General feeling of not feeling well. Constant headache. Took a diuretic twice a day for a week to assist with getting rid of excess fluid weight gain. Still trying to get rid of excess fluid weight gain in June.
49 2021-06-22 swelling face face hurt really bad; face swelled; she scared about the second shot; This is a spontaneous report f... Read more
face hurt really bad; face swelled; she scared about the second shot; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (no pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 09Feb2021 at 13:00 as 1st dose, single for covid-19 immunisation. Medical history included cancer (cancer face, had cancer removed reconstructive surgery have more procedure) from 22Jan2020 and ongoing. The patient had COVID-19 test with positive result on 14Oct2020. Concomitant medications were not reported. No known allergies. No other vaccine in four weeks. No other medications in two weeks. No Covid prior vaccination. No Covid tested post vaccination. On 09Feb2021 at 15:45, her face swelled and hurt really bad 3 hours after the shot, it had been 2 days and was feeling much better and swelling had gone down, she was scared about the second shot (second dose received on 02Mar2021 at 12:30). The events 'face swelled and hurt really bad' assessed as non-serious. The patient received diphenhydramine hydrochloride (BENADRYL), paracetamol (TYLENOL) as treatment for the events 'face swelled and hurt really bad'. Outcome for the events 'face swelled and hurt really bad' was recovered in 2021; of rest event was unknown. Information about Lot/ Batch number have been requested. Follow up (20Apr2021): Ne w information received from a contactable consumer included: medical history, lab data and reaction data (treatment details and outcome of events 'face swelled and hurt really bad' was updated from recovering to recovered). No follow-up attempts are possible; information about lot/batch number cannot be obtained.
49 2021-06-23 anaphylactic reaction Patient had anaphylactic reaction around at 6pm after getting 2nd vaccine (1st was also Pfizer) at 2... Read more
Patient had anaphylactic reaction around at 6pm after getting 2nd vaccine (1st was also Pfizer) at 2pm, and went to hospital. According to patient she did not do anything different on that day other than getting a vaccine.
49 2021-06-23 lymph node swelling High Blood pressure. Fever. Swollen lymph nodes. Swollen throat. Sweating. Faint. Disoriented. Pass... Read more
High Blood pressure. Fever. Swollen lymph nodes. Swollen throat. Sweating. Faint. Disoriented. Passing out. Dizziness. Light headed. Blurred vision. Headache nausea diarrhea runny nose sore throat hot and cold feel like I have a fever. Fatigue. Bed ridden. Couldn?t lift my head off the pillow.
49 2021-06-24 lymph node swelling Swollen lymph nodes; This is a spontaneous report received from a contactable nurse, the patient. A ... Read more
Swollen lymph nodes; This is a spontaneous report received from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: PF208ENG202), via an unspecified route of administration in the left arm on 17Mar2021 at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included pre-type-2 diabetes mellitus, lupus and COVID-19. Concomitant medication included metformin (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN); both for unknown indications, from unknown dates. The patient previously took penicillin for unknown indication and experienced an allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021, the patient experienced swollen lymph nodes. The patient did not receive any treatment for the reported event. The clinical outcome of the event swollen lymph nodes was not recovered. No follow-up attempts are needed. No further information is expected.
49 2021-06-24 lymph node swelling Painful and swollen arm, both at injection site and underarm in lymph nodes. Woke up to pain in the ... Read more
Painful and swollen arm, both at injection site and underarm in lymph nodes. Woke up to pain in the right side of chest, under left arm. Slight fever, body aches, occasional choking, dull headache in back of neck near base of skull.
49 2021-06-25 peripheral swelling I felt my legs like swelling; I had raised rash and both of them on both legs; they were red/I had s... Read more
I felt my legs like swelling; I had raised rash and both of them on both legs; they were red/I had scratchy redness on my arms; I had scratchy redness on my arms; raised rash; they just felt weird; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0191), via an intramuscular route on 21Jun2021 (at the age of 49-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included allergy. Patient allergic to medicines she don't take medicine because she always had a reaction to it like, like Morphine, Oxycodone, Ibuprofen, Tylenol. Patient don't took narcotics. The patient concomitant medications included cetirizine hydrochloride (ZYRTEC) tablet with dose 10 mg for allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jun2021 (5 minutes after vaccination), the patient experienced felt her legs like swelling that they just felt weird and within that 15 minutes after having the shot leg down and her legs, she had raised rash and both of them on both legs and they were red like red and so then, She had scratchy redness on my arms it's a reaction that she get when she take medicines and she had allergic reaction to them. Patient stated that wanted to have check up she had it last week. It's just the Blood test standard blood panel like CBC all the things just the mix of Cholesterol all that, Annual Blood work and said Yes everything was good. Patient took Diphenhydramine HCL (BENADRYL) tablet 25 mg as treatment. About 25 minutes after she got with the Pharmacist and he finally can get a thing It was about 25 minutes after the shot is when she got the Benadryl and it took about 30 minutes from the Benadryl 20-30 minutes that the redness is at least went down, she still had the raised rash but her legs were not red like red they were and now she was at home and it's pretty much subsided the reaction, she don't have the scratchiness and stuff she had few little spots here and there but not anything. The outcome of the events was recovering. Time (24hr) of vaccination: Consumer stated, "My appointment was at 2:30 but I think it was about 2:35 time I got it I don't know about 2:35, 2:40 something central time." Additional information has been requested.
49 2021-06-28 anaphylactic reaction anaphylaxis
49 2021-06-28 peripheral swelling within 5 minutes of shot, my legs started to swell then broke out into raised hives and bright red a... Read more
within 5 minutes of shot, my legs started to swell then broke out into raised hives and bright red all over. The pharmacist gave me Benadryl . Redness subsided after 30 minutes of Benadryl. Hives subsides after several hours later.
49 2021-06-29 lymph node swelling, lymph node pain Migraine; period started 2 days early the day after the shot and slightly heavier bleeding than usua... Read more
Migraine; period started 2 days early the day after the shot and slightly heavier bleeding than usual.; Headache; Fatigue; Mild fever of 99.9; Tenderness of lymph node under left arm; swelling and tenderness of lymph node; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in left arm on 22Apr2021 at 11:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included ZYRTEC and PRILOSEC for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in left arm on 01Apr2021 at 10:45 (at the age of 48-years-old) as a single dose, for COVID-19 immunisation. On 23Apr2021 the body temperature was measured and was found to be 99.9 (unspecified unit). On 23Apr2021 at 07:00 the patient experienced mild fever of 99.9 (unspecified unit), fatigue, swelling, tenderness of lymph node under left arm (lymph node tenderness) and headache. On the same day the patient also reported that period started 2 days early the day after the shot and slightly heavier bleeding (bleeding menstrual heavy) than usual. On 25Apr2021 3 days after the shot the patient had experienced migraine. The clinical outcome of events lymph node tenderness, swelling, bleeding menstrual heavy, headache, pyrexia, fatigue was recovered on an unspecified date in Apr2021; while that of the event migraine was unknown. No follow-up attempts are needed. No further information is expected.
49 2021-06-29 lymph node swelling Arm soreness at injection site - swollen, itchy and sore. That lasted for three days. I got some swe... Read more
Arm soreness at injection site - swollen, itchy and sore. That lasted for three days. I got some swelling in lymph node under the arm. I had all over body aches that I treated with ibuprofen and those lasted about 36 hours. On Wednesday, 3/31/2021, I got a sore throat and had really bad tonsillitis for about four days ( Wed- Sunday 4/4/2021). If I had a temp it wasn't significant. I didn't have spots in my throat - just a really bad sore throat. Around 4/5/2021, I started getting an ear infection later in that day. April 7, Ear infection got really, really, really bad. By 01:00 pm, my eardrum was starting to perforate. I had intense pain and fluid coming out of my ear. Called my doctor and he started me on antibiotics and Hydrocodone and high dose ibuprofen and compress helped. By 6:00 pm, it was done perforating. It took about 4 weeks for it to heal.
49 2021-06-29 lymph node swelling I've had swollen lymphnodes in my clavicles, my neck, and underneath my chin since I received the se... Read more
I've had swollen lymphnodes in my clavicles, my neck, and underneath my chin since I received the second dose of the vaccine. I was giving four rounds of antibiotics from my doctor, but they are still here.
49 2021-06-29 lymph node swelling Swollen lymph node around left collarbone; This is a spontaneous report from a contactable consumer.... Read more
Swollen lymph node around left collarbone; This is a spontaneous report from a contactable consumer. A 49-year-old adult non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 04Mar2021 at 17:15 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient medical history included obesity, arthritis and back stenosis. The patient had nuts allergy. Concomitant medications included unspecified antibiotic, vitamins and cough medicine from an unspecified date. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On an unspecified date in Mar2021 at 12:00, the patient experienced swollen lymph node around left collarbone. No therapeutic measures were taken as a result of adverse events. The clinical outcome of swollen lymph node around left collarbone was recovering at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
49 2021-06-29 swelling face, peripheral swelling Chills; Headache; Muscles hurt; Face swollen; Hands swollen; It hurts to walk; This is a spontaneous... Read more
Chills; Headache; Muscles hurt; Face swollen; Hands swollen; It hurts to walk; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in left arm on 19Mar2021 at 09:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. It was reported that the patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications (unspecified) were taken within two weeks of vaccination. On 19Mar2021 at 22:00, the patient experienced chills, headache, muscles hurt, hands and face swollen and hurts to walk. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, headache, muscles hurt, hands and face swollen and hurts to walk were not recovered at the time of this report. Information about lot number cannot be obtained. No further information is expected.
49 2021-06-30 anaphylactic reaction Anaphylaxis; This is a spontaneous report received from a contactable consumer or other non hcp. A 4... Read more
Anaphylaxis; This is a spontaneous report received from a contactable consumer or other non hcp. A 49-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EWU185) via an unspecified route of administration in left arm on 13May2021 at 19:00 (age at vaccination 49 years old, Pregnancy at time of Vaccination: No) as first dose, single for COVID-19 immunization. Medical history included Sjogren's syndrome, Reynauds, Ankylosis, Spondylitis and multi-nodular thyroid. Patient was allergic to Amoxicillin, Lamotrigine, Gabapentin, IV Contrast, peanuts, tree nuts and shellfish. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included lithium (LITHIUM), cariprazine hydrochloride (VRAYLAR) and amfetamine aspartate monohydrate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (MYDAYIS). Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced anaphylaxis on 13May2021 at 19:00. The event resulted in Emergency room/department or urgent care. The patient received treatment for the adverse event in hospital. The patient was hospitalized for anaphylaxis on an unspecified date in 2021. The outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
49 2021-06-30 lymph node swelling, swelling face Face swollen; Hives and itching, mostly upper body. Chest and arms/Hives all over the body; Swollen ... Read more
Face swollen; Hives and itching, mostly upper body. Chest and arms/Hives all over the body; Swollen gland under the left arm; Arm irritation on the sight of the shot; Itchy scalp, slightly swollen top lip; Itchy scalp, slightly swollen top lip; 3/5 Slight sore throat; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6199, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 05Mar2021 19:00 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to the vaccination. Medical history included asthma from an unknown date. The patient has allergy to penicillin and omeprazole magnesium. The patient's concomitant medications were not reported. Since the vaccination the patient had not been diagnosed with COVID-19. On 05Mar2021 19:30, post vaccination the patient experienced slight sore throat. On 11Mar2021 19:30, the patient had itchy scalp, slightly swollen top lip. On 12Mar2021, the patient felt arm irritation on the sight of the shot. On 13Mar2021, the patient had swollen gland under the left arm. On 15Mar2021, it was reported that the patient developed hives and itching, mostly upper body, chest and arms/hives all over the body. On 17Mar2021, the patient had her face swollen. On 17Mar2021, the patient had to go to the emergency room due to the events. The patient was treated with Zyrtec, Pepcid IV, Deltasone and Benadryl. The outcome of the events was reported as not recovered at the time of report. Information on Lot/Batch number was available. Additional information has been requested.
49 2021-07-01 peripheral swelling I have had muscle cramps, fevers, fatigue, headache, cough, shortness of breath , aches and pains ... Read more
I have had muscle cramps, fevers, fatigue, headache, cough, shortness of breath , aches and pains whole body, stomach pain, nausea, unable to sleep long periods. Taste and smell issues, itchy hives, swollen itchy eyes, swollen lower extremities.
49 2021-07-01 peripheral swelling fever shot to 103; Vomiting; Headache; Body pain; Arm swoll to double its size from shoulder to elbo... Read more
fever shot to 103; Vomiting; Headache; Body pain; Arm swoll to double its size from shoulder to elbow; Pain in my feet; Broke blood vessels in my upper body; Dry heaving.; Nausea; This is a spontaneous report received from a contactable consumer, the patient. A 49-years-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unknown route of administration on right arm the 20Mar2021 at 10:15 (age at vaccination 49-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis. The patient received unspecified medications within 2 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took VIOXX, LEVEQUIN and DEMEROL; developed allergy for all the drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 10:30 (within 15 minutes), the patient experienced nausea, overwhelming headache, body pain, right arm was swollen to double its size from shoulder to elbow and the patient broke her blood vessels in upper body from dry heaving. At 11:00, nausea led to vomiting and the patient could not hold any liquids. At 12:30, the patient had fever 103 (units unspecified). The events of vomiting and nausea were debilitating for the next 24 hours and patient's overall body pain became unbearable. The major effects lasted more than 24 hours. On an unknown date in Mar2021 (72 hours after vaccination), the patient was still feeling nauseated, body pain was still off and on, and patient felt she was having flu at that point and stated first 24 hours was a nightmare. Therapeutic measures taken as results of events and included treatment with BENEDRYL or TYLENOL, but she couldn't hold down anything. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of events nausea, vomiting, headache, body pain, arm swollen, pain in feet, fever, Injury to blood vessel of head and neck and dry heaves were recovered with sequalae on an unknown date in Mar2021. No follow-up attempts are possible. No further information is expected.
49 2021-07-07 peripheral swelling continuous pain in arm 2 days after shot, cant move swollen red mark on arm wont go away cant sleep
49 2021-07-08 peripheral swelling This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnan... Read more
This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 24Mar2021 at 10:30 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included birth control medications, herbal and dietary supplements; all for unknown indications from unknown date. The patient previously received tetracycline and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 24Mar2021 at 11:00, the patient experienced some headache and in night, the patient's upper arm and surrounding area was sore. On 25Mar2021, the day after the vaccination, the patient's arm was bit swollen and she had chills but doesn't show up as a fever. The patient reported that she did not seem to have headaches but felt that she was on a verge of getting a fever. The patient did not receive any treatment for the reported events. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events headache, upper arm and surrounding area was sore, swollen arm and chills were resolving. No follow-up attempts are possible. No further information is expected.
49 2021-07-13 peripheral swelling April 1st, I had leg pain and swelling. I went to the doctor - I had a blood clot in my leg. I had t... Read more
April 1st, I had leg pain and swelling. I went to the doctor - I had a blood clot in my leg. I had to go on blood thinners.
49 2021-07-13 swelling Came in for dose #2 of Pfizer Covid19 vaccine, reports severe allergy type reaction to dose #1. Sta... Read more
Came in for dose #2 of Pfizer Covid19 vaccine, reports severe allergy type reaction to dose #1. States waited 15 minutes in office after vaccination #1 then walked to her car. When arrived at her car, felt "heat" and "fullness" swelling of throat, chest, upper airway. States had fast heartbeat and severe dizziness and weakness, spinning. Denies rash, itching or hives or difficulty breathing. Because she was able to breathe, she stated she decided not to return to the hospital, went home. States resolved on its own, dizziness lasted into the next day. Per fact sheet for Recipients and Caregivers, this describes a severe allergic reaction to previous dose of Pfizer vaccine and dose #2 is contra-indicated. Discussed at length. Verbalizes understanding.
49 2021-07-16 peripheral swelling SORENESS AT INJECTION SITE, JOINT PAIN, VERTIGO, LEG SWELLING
49 2021-07-17 lymph node swelling, lymph node inflammation having paranoid issues; she was not able to sleep and she was up all night; psychotic break; dizzy; ... Read more
having paranoid issues; she was not able to sleep and she was up all night; psychotic break; dizzy; and possibly a neurological one as well; swollen lymph node; the right side of her body and leg especially and her arm are less strong; COPD; she was feeling worse; Sjogrens symptom; Dry Mouth; had autoimmune reaction to it; chest pain; unable to walk due to joint pain; Lymph Node Inflammation; fatigue was getting worse; Doesnt feel well; This is a spontaneous report from a contactable consumer or other non hcp. A 49-year-old female patient received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number ER8727 Expiry date 31Jul2021) dose 1 on 23Mar2021 and dose 2 via an unspecified route of administration, administered in Arm Right on 13Apr2021(Age at vaccination was 49-years-old) (Lot number was ER8731 and Expiration Date: 31Jul2021) as a single dose for COVID-19 immunisation. Medical history included, pyrexia and non-tobacco user from an unknown date and unknown if ongoing she is a non-smoker, tuberculosis from an unknown date and unknown if ongoing in 1976 , malaria from 1993 to an unknown date. The patient's concomitant medications were not reported. On 15Apr2021 lymph node inflammation or neoplastic spots, a 1.5cm spot on the parotid gland, fatigue was getting worse, doesnt feel well and unable to walk due to joint pain. Caller states it started with Lymph Node inflammation on the left side and she tried to wait two weeks, using a hot compress and it didn't get better so she went to her doctor on 27APR2021 and had her look at it. she also feels fatigue, exhausted, and she doesn't feel well. Caller states that is not normal for her, she is an avid biker, and rides long distance, and now she is barely walking some days. On 24Apr2021 she was in the ER for her chest pains, they recommended an Echo, but her insurance denied it. On 27Apr2021 had autoimmune reaction to it and possibly a neurological one as well and sjogrens symptom also had dry mouth. She was having paranoid issues and hearing things and hearing biofeedback. Caller states she was in the psych ward until 02Jun2021, then she came home. Patient stated she had a neuro appointment when she was in the psych ward and they recommended a lumbar puncture, but she hasn't done it yet, but she may be doing it shortly. She was not able to sleep, and she was up all night and dizzy due to these all events patient was hospitalized from 26May2021 to 28May2021. On an unspecified date patient had swollen lymph node the right, side of her body and leg especially and her arm are less strong and she was feeling worse.Patient stated she ran a bunch of tests like Lyme Disease, Mono, Chest X-Ray which showed COPD. The patient underwent lab tests and procedures which included chest x-ray: no copd on had chest x-rays that show no COPD, chest x-ray: COPD on 21May2021 Chest X-Ray which showed COPD, computerised tomogram: unknown, computerised tomogram thorax: unknown, lyme disease: unknown, on 21May2021, magnetic resonance imaging head: unknown. she was taking Zyprexa. Patient states first it was 10mg, then they cut it in half to 5mg, and now she is taking 2.5mg. Caller states she got out exactly a month ago. Patient states it took a few days more while she was at home to fully recover. Patient states she thinks she was part of a study. Patient stated she does remember everything that she was thinking, sometimes that is how it works, and the paranoia and it was not a pretty time. Patient was also on Meloxicam 7.5mg due to event psych disorder. Outcome of the events psychotic break recovered on an unknown date and had autoimmune reaction to it, sjogrens symptom, lymph node inflammation, fatigue was getting worse , doesnt feel well, unable to walk due to joint pain, dry mouth and chest pain not recovered and rest all the events were unknown.
49 2021-07-17 lymph node swelling L Supraclavicular nodes x 2 (node #1 size of dime; node #2 size of penny); L arm soreness at injecti... Read more
L Supraclavicular nodes x 2 (node #1 size of dime; node #2 size of penny); L arm soreness at injection site.; swelling at injection site.; tenderness at injection site.; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in left arm on 27Mar2021(at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included DM2, HTN, Vitamin D deficiency, seasonal allergies, eczema, catfish/nickel allergies. Concomitant medications included lisinopril; hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASA), metformin hydrochloride (METFORMIN ER), cholecalciferol (VITAMIN D3) for unknown indication from unknown date. The patient had known allergies to catfish and nickel. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021, the patient experienced L supraclavicular nodes x 2 (node #1 size of dime; node #2 size of penny); left arm soreness, swelling, tenderness at injection site. It was reported that nodes were still present at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events lymph nodes enlarged, left arm pain, vaccination site swelling and vaccination site pain was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
49 2021-07-17 peripheral swelling Actually vomited earlier because it made me vomit, that actually the head thing is horrible; It was ... Read more
Actually vomited earlier because it made me vomit, that actually the head thing is horrible; It was out of my sleep, cant sleep; Getting worried; It is really weird; Am laying in the black room because light is hurting my head so bad; Most terrific headache and each day, its getting worse and worse, and getting very, and my head, the pain is unbelievable; left arm blew up, its looks like a baseball and it's got hard, whole arm got all, It was so swollen for 4 days; Got the Pfizer shot and got sick for 3 or 4 days; This is a spontaneous report from a contactable consumer (the patient). A 49-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: ER8734; Expiration Date: 31Jul2021) via an unspecified route of administration, in left arm on 19Jun2021 13:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation; oxycodone hydrochloride, paracetamol (PERCOCET), route of administration, start and stop date, batch/lot number and dose were not reported for back disorder; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for headache; oxycodone, route of administration, start and stop date, batch/lot number and dose were not reported for back disorder, intervertebral disc protrusion. Medical history included back problems, severe spinal stenosis, Osteoarthritis, MALS (Median arcuate ligament syndrome, It was vascular problem under stomach, it's very rare and should undergo another surgery for that), severe back pain, herniated disc (11 herniated disc and the back operation), endometriosis (had 8 endometriosis surgery. Had been on oxycodone because had severe endometriosis), complement deficiency disease (it is a rare autoimmune disease), sickly, all from an unknown date and unknown if ongoing. On an unspecified underwent hysterectomy (had 8 pelvic surgeries including a hysterectomy and gained ton of weight). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Jun2021, the patient experienced most terrific headache and each day, its getting worse and worse, and getting very, and my head, the pain is unbelievable, left arm blew up, its looks like a baseball and it's got hard, whole arm got all, It was so swollen for 4 days, got the Pfizer shot and got sick for 3 or 4 days. On an unspecified date, the patient stated that actually vomited earlier because it made me vomit, that actually the head thing is horrible, it was out of my sleep, cant sleep, getting worried; it is really weird, am laying in the black room because light is hurting my head so bad. It was reported that the patient had the first Pfizer shot 8 days ago and now experiencing the most terrific headache started two days after getting the Pfizer shot and each day it was getting worse and head pain is unbelievable and now it was so uncontrollable. The patient stated that it's been a whole week and headache was getting worse. The patient stated that she was taking Tylenol and Percocet because of a bad back and my husband put ice all around my head and my temporal. The patient reported that she can't, it that plead, it hurt so bad and it felt like so much pain all over around her head. The patient stated she don't normally take Tylenol because it could cause liver problems but taking it after the shot a little bit after the headache and it was hardly controlling it. Consumer stated she has been taking oxycodone for 10 years because of back disease and 11 herniated disc, that not causing the headache, that's not something new, and never had headache like this in my life, it was out of my sleep, can't sleep, it was horrible. It was like somebody at both sides of my head like and they have like rice strips in there crushing it. The patient stated that as a treatment she tried Tylenol and Motrin the other day. Consumer stated, left arm blew up its looks like a baseball and it was got hard, my whole arm got all it was so swollen for 4 days and now it was okay, it went down. Consumer further stated that she was laying in the black room because light is hurting her head so bad. Consumer stated still experiencing event: When she got the shot and got sick for 3 or 4 days. Had a terrible headache and then she started feeling better. Now, on day 6th, 7th and 8th day after the first Pfizer shot, the headache came back and it is worse. The patient was supposed to go get her second shot in about 2 weeks but the pharmacist told her to come 2 or 3 weeks later i.e. on 17Jul2021 as she could go to 4 weeks because she had auto-immune diseases, already with problem and so worried about getting the shot. The patient was worried and wanted to talk to someone at Pfizer to find what should be done or it was normal, or should go to the hospital. The action taken in response to the events for Percocet, Tylenol and oxycodone was unknown. Therapeutic measures were taken as a result of most terrific headache and each day, its getting worse and worse, and getting very, and my head, the pain is unbelievable. The outcome of events "most terrific headache and each day, its getting worse and worse, and getting very, and my head, the pain is unbelievable" and "Got the Pfizer shot and got sick for 3 or 4 days" was not recovered, outcome for "Left arm blew up, its looks like a baseball and it's got hard, my whole arm got all, It was so swollen for 4 days" was recovered on an unspecified date in Jun2021 and outcome for rest all events was unknown. Information on Lot/Batch number was available. Additional information has been requested
49 2021-07-17 swelling face She got filler under her eyes, what they tear throughs; She had a big puff under her eye, and a grow... Read more
She got filler under her eyes, what they tear throughs; She had a big puff under her eye, and a growth on the side of her face; She had a big puff under her eye, and a growth on the side of her face; There was an infection from the filler; This is a spontaneous report from a contactable consumer (patient herself). Report 1 of 2. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm, dose 1 on 16Apr2021 at 09:30 (at the age of 49-year-old, Lot number: EWO164, Expiration date: 31Aug2021), dose 2 on 07May2021 at 11:30 (at the age of 49-year-old, Lot number: EWO170, Expiration date: 31Aug2021); Both for single for COVID-19 immunization. The patient's medical history included multiple sclerosis (she has had since she was 30). Reporter stated no, there are no medical conditions, and she was not on anything. Reporter was asked how long she has had multiple sclerosis for and stated since she was 30, but she was not good at math so does not know how long. Concomitant medications were unspecified medications. Family medical history relevant to adverse events were none. No prior vaccinations (within 4 weeks). She did not do vaccines honestly, she got what she got when she was a kid, and she did not do flu shots. She did not do those things. She was very against getting this. Adverse events following prior vaccinations were none. No vaccines administered on same date of the Pfizer suspect. It was reported that, reporter was calling about the Pfizer COVID-19 vaccine. She reported her experience at which time she also mentioned people who had a similar experience. Report 1 was reporter calling about herself. Reporter stated that she has been having some issues, she got the Pfizer vaccine, the first one, and it was 16Apr2021. Two weeks after that, she got filler under her eyes, what they tear throughs on an unspecified date in 2021. She looked like an alien: Reporter stated she got filler under her eyes, and she looked like an alien. She had a big puff under her eye, and a growth on the side of her face on an unspecified date in 2021. She has gone to every doctor and nobody knew. They gave her antibiotics and never saw anything like this. Reporter added that usually it was unheard of that there was an infection from the filler. She was given antibiotics, steroids, and all sorts of things. She looked like an alien: Reporter stated it was the left side that started with, and it was not really under control. On an unspecified date in May2021, she got her second shot, and a few days later she had the same effect under both of her eyes. Reporter stated she would be 50. Reporter stated none of her dermatologists, she just did not go to a girl who opened a place up because she did not do that, she went to a highly recommended dermatologist and after that when she did not know what to do, she went to several other dermatologists. She started to research. She saw a girl on the news who had half-moon puffs, but she had them also. She went to the dermatologist who did this and said it was only Moderna. Reporter stated no it was Pfizer and only three people have experienced this which was a lie unless she was just number 4 then. As she asked around or tells her story, people say oh that happened to my friend and my friend had that. It was not just Moderna. Reporter did not have any additional information on three people that she mentioned. Reporter did not want to file a report at this time for the girl that she mentioned on the news because she did not know her name and it was all over the news. Reporter looked at her phone and reads from a picture that her filled was on 25Jan2021 so it must have been on the 29. The 29 she looked like she was a monster. So, what they have been doing was putting the dissolver in - it was PRIVACY, and they have been like injection under her eyes with it to get rid of it or dissolve it. Reporter added that it was getting better, but she still has these things under her eyes. Reporter did not know any information on the filler. Reporter stated she has it written down in her bag. It was Volumna received on 25Jan2021. Reporter confirmed that she received the filler on an unspecified date in Jan2021. She received her vaccines on 16Apr2021 and 07May2021 and her symptoms she was reporting started after this. Reporter added she was totally fine, then she woke up with things under her eyes. It was unsightly, she looked like a monster. Reporter added she was sorry she got the vaccine to be honest. Reporter added she was stuck with this. Reporter asked the vaccine did not ever go away, did it. Stated she got them in her arm, wasn't that where people get them, and her left arm she thought. Antibody test said she had none, Indication: Her neurologist guilted her into getting it because she has multiple sclerosis and if she did not get it, she would die.Two weeks after her second vaccine, the neurologist sent her for an antibody test and when it came back it said she had none. Reporter stated her dermatologist things it may be because the medication she takes for her multiple sclerosis that she did not have antibodies. Reporter stated that the medication was Ocrevus infusion once every 6 months. It was a therapeutic infusion. Reporter added that her first infusion was 13Jul2017 and has no additional details regarding the medication. Reporter could not locate dose or any additional information. Investigations: Reporter stated no. Reporter did not have details on when she received the testing. She added that it was bloodwork aside from the antibody test. Nobody did anything else. No additional details provided. Reporter added the first time, there was a big thing on the side of her face, and she took antibiotics but could not remember what they were and a round of steroids on a 5 day taper. No additional details are known. The adverse events did not require a visit to emergency room. The adverse events required a physician office visit. She has been visited to several doctor's offices because of this adverse events. Patient cries every day and did not want to walk around with these things on her face. Reporter added she knew this whole phone call would be useless and she was tired of doctors always saying it could not be because she received the Moderna. Reporter was asked for clarification of her statement and states she did not received the Moderna, she received Pfizer. Reporter stated she could not be the only one this happened to. The doctor said it was only if you have Moderna, and she said no it was not because she had Pfizer. She felt like Pfizer should know. Other people have experienced this, and she just thought it was like she felt like Pfizer should know. Nobody else, not many people, would take time to call or thought to call. She followed a dermatologist who had people come to him with issues and he was in PRIVACY and gives steroids and antihistamines. She took Claritin, she did not think it was helping. Reporter was unclear on the timeline of when she received the vaccine and when she started having symptom. Reporter was asked if her symptoms began after receiving the Pfizer Covid-19 Vaccine and stated yes. Reporter confirmed dates of vaccines and dates of events and that they occurred after she received the vaccine. Reporter was heard several times talking to somebody in background and yelling. On an unspecified date in 2021, the patient underwent lab tests and procedures which includes antibody test: Negative and blood work: Unknown results. The outcome of the events was not resolved. Description of Product Complaint: Description of complaint: Reporter was calling about the Pfizer Covid-19 vaccine and how she experienced looking like an alien after receiving the vaccine. Reporter followed a dermatologist who had people come to him with issues and he was in PRIVACY and gives steroids and antihistamines. She took Claritin, she did not think it was helping. Reporter did not have manufacturer, NDC, LOT, or expiration and did not have the box because she threw it away since she only had 2 left. No additional details provided. Follow-up attempts are completed. No further information is expected.
49 2021-07-18 lymph node swelling The day following her second injection, she developed axillary adenopathy. Over the next 2 weeks she... Read more
The day following her second injection, she developed axillary adenopathy. Over the next 2 weeks she developed symptoms of headache, nausea, fatigue, frequent urination and dyspnea.
49 2021-07-20 swelling I remained at center for 30 minutes. After leaving, I developed hives within 10 minutes. The insides... Read more
I remained at center for 30 minutes. After leaving, I developed hives within 10 minutes. The insides of my nostrils and to tongue swelled.; nostrils swelled; tongue swelled; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 19Mar2021 at 16:00 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included asthma, penicillin and all variants allergy, latex allergy, plastic bags like grocery store allergy, pumpkins allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC) from an unknown date for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 16:45 (as reported), the patient remained at centre for 30 minutes. After leaving, experienced hives within 10 minutes, the insides of nostrils and to tongue swelled. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome for the events hives, nostrils swelling and tongue swelling was resolved on an unknown date in 2021. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
49 2021-07-23 swelling Swelling and redness similar to COVID arm
49 2021-07-27 axillary mass, lymph node swelling, neck mass lump on her underneath her arms; on her neck, there was a lump there also; body was aching; she has ... Read more
lump on her underneath her arms; on her neck, there was a lump there also; body was aching; she has a lump on her underneath her arms and lymph node swelling on the underarms and neck; Felt really sick; a little bit of fever; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Jul2021 as dose 1, single (at the age of 49 years) for COVID-19 immunisation. Medical history included having had the Covid virus before. The patient's concomitant medications were not reported. On 11Jul2021 (Sunday) in morning, the patient felt really sick and had a little bit of fever, body was aching and in afternoon, she had a lump on her underneath her arms and lymph node swelling on the underarms and also in her neck next to collarbone which began on Sunday. Then on 11Jul2021, she started feeling the lumps under the arm and on her neck, there was a lump there also. Patient further wanted to know if these were normal and if patient needs to go to the doctor. The outcome of events was unknown. Information on lot/batch number has been requested.
49 2021-07-27 lymph node swelling, lymph node pain Lymph nodes swollen and sore, extreme fatigue now lasting 12 weeks and counting. I have tried vit C... Read more
Lymph nodes swollen and sore, extreme fatigue now lasting 12 weeks and counting. I have tried vit C IVs and am still suffering extreme fatigue
49 2021-07-27 lymph node swelling SWOLLEN LYMPH NODES IN ARMPIT OF ARM THAT RECEIVED SHOT; This is a spontaneous report from a non-con... Read more
SWOLLEN LYMPH NODES IN ARMPIT OF ARM THAT RECEIVED SHOT; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Apr2021 at 11:15(at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and levothyroxine sodium (LEVOTHYROXIN),all from unknown dates and for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Mar2021 at 11:15(at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 04Apr2021 at 07:00, the patient experienced swollen lymph nodes in armpit(lymphadenopathy axillary) of arm that received the shot. The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event swollen lymph nodes in armpit was not recovered at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
49 2021-07-27 lymph node swelling Severe stomach pain; Swollen glands; Vomiting; Severe headache; Severe fatigue; Knot in arm; Sore ar... Read more
Severe stomach pain; Swollen glands; Vomiting; Severe headache; Severe fatigue; Knot in arm; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Mar2021 at 08:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. It was unknown whether the patient had any allergies to medications, food, or other products. Concomitant medications included ziprasidone (MANUFACTURER UNKNOWN), clonazepam (MANUFACTURER UNKNOWN) and fluoxetine (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Mar2021 at 08:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021, right after second dose, the patient experienced sore arm and knot in arm (muscle spasm). On 28Mar2021 at 20:00, two days after second dose, the patient experienced severe fatigue and severe headache. On 02Apr2021, one week after second dose, the patient experienced vomiting, severe stomach pain, swollen glands and severe fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported adverse events. The clinical outcome of the event sore arm, knot in arm (muscle spasm), severe fatigue, severe headache, vomiting, severe stomach pain and swollen glands was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
49 2021-07-27 peripheral swelling history included type 2 diabetes, high cholesterol, high blood pressure and neuropathy; all were fro... Read more
history included type 2 diabetes, high cholesterol, high blood pressure and neuropathy; all were from an unknown date and unknown if ongoing. Concomitant medications included metformin, ergocalciferol (VIT D), amlodipine and paliperidone (INVEGA [PALIPERIDONE]); all were taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient experienced My body got really hot, cold sweat, Right leg is swollen and my feet swollen; I got pain in my leg and headache. Consumer stated as, got a question, Pfizer vaccine yesterday for the first time and my body got really hot last night and I had like cold sweat last night. Is that one of the side effects. My body got really hot you know I had to take cold shower to cool down and my right leg was swollen and my feet swollen. I got type 2 diabetes, I got neuropathy in my feet (history). I got pain in my leg and it was my first shot. The patient further stated, I want to ask was this make me sweat, body was hot it make me sweat. I just want to know if this is the side effect. The patient took a cholesterol pill and took a blood thinner too. Only got really really hot sweat last night again, the day I got really really hot again like come home took a cold shower and cool down with a fan. I had no fever only got really really hot. Therapeutic measures reported as, patient took two Tylenol for the headache, it was like a slight headache. No investigation assessment reported. Outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
49 2021-07-27 swelling With the chills symptom I had severe tremors that lasted over 3 hours; With the chills symptom I had... Read more
With the chills symptom I had severe tremors that lasted over 3 hours; With the chills symptom I had severe tremors that lasted over 3 hours; Headache; Arm pain; Swelling; Muscle ache; Fatigue; Depressed appetite; Low body temperature ranging from 97.7 to the lowest at 97.0 within the 24 hours after the vaccine was received.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (non-pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP7533), via an unspecified route of administration on right arm on 21May2021 01:30 PM (age at vaccination: 49 years) as dose2, single for COVID-19 immunization at hospital. The patient medical history included Known allergies to Bandage adhesive. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient Concomitant medications within 2 weeks of vaccination included Multi-Vitamin. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6704), via an unspecified route of administration on Right arm on 30Apr2021 01:15 PM (at the age of 49 years) as dose 1, single for COVID-19 immunization. On 22May2021 12:15 AM, the patient experienced chills symptom she had severe tremors that lasted over 3 hours. she also had headache, arm pain and swelling, muscle ache, fatigue, and depressed appetite. In addition she had a low body temperature ranging from 97.7 to the lowest at 97.0 within the 24 hours after the vaccine was received. Since the vaccination, the patient has not been tested for COVID-19. The lab tests included test: Low body temperature, result: 97.7-97 (Low body temperature ranging from 97.7 to the lowest at 97.0 within the 24 hours after the vaccine was received) on 22May2021. It was reported that the awareness date 22May2021 is the same date that she began experiencing the symptoms. Due to the fatigue and feeling unwell she was not able to actually file the report until Sunday, 23May2021, but she did experienced the symptoms the previous day, Saturday, 22May2021. The patient did not receive any treatment for the events. The outcome of the events chills, tremors was recovered on 22May2021, while other events was recovering.
49 2021-07-28 lymph node swelling, lymph node pain Fully bed ridden; Extreme fatigue; fever/ fever averaged at 100.9; Extreme swelling under arm by arm... Read more
Fully bed ridden; Extreme fatigue; fever/ fever averaged at 100.9; Extreme swelling under arm by armpit; Pain continues below armpit; severe congestion; Dizzy and lightheaded; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 13Apr2021 at 08:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, herpes simplex (HSV), asthma, obesity, high cholesterol and had allergies to sulfates, shell fish, seasonal allergies. Concomitant medications included quetiapine fumarate (SEROQUEL) and valaciclovir (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 13Apr2021 at 09:15, the patient experienced dizzy and lightheaded after 30 minutes of dose. On 13Apr2021 at 17:15 the patient experienced extreme swelling under arm by armpit for a total of 10 days, pain continues below armpit 20 days after initial dose, severe congestion continues 20 days after initial dose, fever averaged at 100.9 for 8 consecutive days, starting at 8.5 hours after dose. On 14Apr2021 at 08:45 the patient experienced extreme fatigue and fully bed ridden starting 24 hours after dose for a total of 4 days. The events resulted in doctor or other healthcare professional office/clinic visit. On 30Apr2021, the patient underwent nasal swab and the result was negative. The clinical outcomes of dizzy, lightheaded, extreme swelling under arm by armpit, pain continues below armpit, severe congestion, fever averaged at 100.9, extreme fatigue and fully bed ridden were not recovered. No follow-up attempts are needed. No further information is expected.
49 2021-07-29 c-reactive protein increased C-Reactive protein blood test went up 30 points; She experienced a flare of her Crohn's Disease she ... Read more
C-Reactive protein blood test went up 30 points; She experienced a flare of her Crohn's Disease she never had in her life; She can't eat or hold anything down; She can't eat or hold anything down; it has gotten worse/ Event: Overactive flare was reported as worsened; overactive flare like she has never experienced in her immune system; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received BNT162b2 (COVID-19 vaccine, Solution for injection, Lot No: EW0271), via an unspecified route of administration, administered in Arm Left on 06Jun2021 as 1stdose, single for covid-19 immunisation (age at vaccination is 49 years). Medical history included crohn's disease from 2006 and ongoing. The patient's concomitant medications were not reported. The patient experienced a flare of her crohn's disease she never had in her in 2021, she can't eat or hold anything down in 2021, it has gotten worse/ event: overactive flare was reported as worsened on 2021, c-reactive protein blood test went up 30 points on 11Jun2021. The patient underwent lab tests and procedures which included c-reactive protein went up 30 points on 11Jun2021, C-Reactive Protein went back down the 30 points two weeks later. Patient received one dose of the Pfizer Covid-19 Vaccine. On unspecified date in 2021 she experienced a flare of her Crohn's Disease she never had in her life. She can't eat or hold anything down and it has gotten worse since she received the vaccine. She has had no relief, and no one knows what to do. She has held off receiving the second dose of the vaccine. She was advised to get a spike protein qualitative antibody test. She is asking what do the results mean. Her doctor and the lab could not help reviewing the results with her. She thinks she is going to end up in the hospital if this continues. Patient is asking should I take the second vaccine, having Crohn's Disease is there any information or trials other than immunocompromised people were not involved in the clinical trials and that people immune compromised may have a lower response. History and Investigations about the patient was C-Reactive Protein went back down the 30 points two weeks later. Upon follow-up16Jul2021 spontaneous report; contactable consumer (patient) reported about patient characteristics (Age at time of onset of reaction/event, sex, medical history and concurrent conditions, Patient medical start date, Reactions and events details, drug information, History and Investigations details). Outcome of the events were recovered/not resolved except C-Reactive protein blood test went up 30 points was recovered/resolved on unspecified date. Follow-up (16Jul2021): This is a follow-up spontaneous report. A contactable consumer (patient) reported about patient characteristics (Age at time of onset of reaction/event, sex, medical history and concurrent conditions, Patient medical start date, Reactions and events details, drug information, History and Investigations details.
49 2021-07-29 swelling face Exactly 20 minutes post-vaccination. Tongue felt odd like swelling; Exactly 20 minutes post-vaccinat... Read more
Exactly 20 minutes post-vaccination. Tongue felt odd like swelling; Exactly 20 minutes post-vaccination. Tongue felt odd like swelling, then left side of face to include ear and below left eye, upper and lower jaw affected (left side only). (Odd numbness)Complete left; (Odd numbness)Complete left side of face; Very little tingling in left side lower lip.; Still have some lingering weird feeling 3hr 45mins later.; This is a spontaneous report from a contactable nurse. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729), via an unspecified route of administration in the left arm on 07Apr2021 at 10:30 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications included zinc oxide (ZINC) from unknown date for unspecified indication and daily vitamin from unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 10:50, exactly 20 minutes post-vaccination, the patient experienced tongue felt odd like swelling, then left side of face to include ear and below left eye, upper and lower jaw affected left side only, odd numbness complete left side of face felt as if the patient had been injected by the dentist with lidocaine, very little tingling in left side lower lip which started to subside about 2 hours later, still have some lingering weird feeling 3hr 45 mins later. The events did not result in doctor or other healthcare professional office/clinic visit or emergency visit. No therapeutic measures were taken as a result of the reported events. On an unknown date, the patient underwent blood pressure test and the result was normal. On 07Apr2021, the patient underwent lab test and procedures which included BP, RR, HR and the results were found to be normal. The clinical outcome of the event very little tingling in left side lower lip was recovered on 07Apr2021 at 12:45. The clinical outcome of the events tongue felt odd like swelling, then left side of face to include ear and below left eye, upper and lower jaw affected (left side only), odd numbness complete left side of the face and some lingering weird feeling were unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
50 2021-01-03 lymph node swelling, lymph node pain Swollen painful lymph node left clavicle
50 2021-01-04 lymph node swelling, peripheral swelling temperature between 100.5 to 101.8, swelling of L arm (sever) and pain into arm pit, swelling of lym... Read more
temperature between 100.5 to 101.8, swelling of L arm (sever) and pain into arm pit, swelling of lymph nodes
50 2021-01-04 swelling face day of vaccine: dull headache for the majority of the day (I don't typically get headaches) 2 days ... Read more
day of vaccine: dull headache for the majority of the day (I don't typically get headaches) 2 days after vaccine: minor bilateral rash on face - both cheeks red, slightly raised bumps, no itching or pain, lasted for about 24-36 hrs
50 2021-01-04 swelling underneath my armpit is a little bit swelling; arm hurt a little bit more; headache; body hurting he... Read more
underneath my armpit is a little bit swelling; arm hurt a little bit more; headache; body hurting her; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH5730), via an unspecified route of administration on 28Dec2020 at single dose for Covid-19 immunisation. There were no medical history nor concomitant medications. The consumer received the vaccine on the 28Dec2020. She doesn't have a prescribing doctor. During the night after receiving the vaccine, her body was hurting her on 28Dec2020. She started to develop side effects 4-5 hours after receiving the vaccine. The side effects started during the evening the same day she got the shot. On 29Dec2020, the side effects were worse, she had a headache, and her arm hurt a little bit more. She then realized under her armpit was swollen a little bit / underneath her armpit was a little bit swelling on 30Dec2020. She talked to someone earlier about this and they told her to call her doctor. She had a lot of headaches. Everything is hurting her. The outcome of under her armpit was swollen a little bit was not recovered, of her arm hurt a little bit more was unknown. The outcome of the other events was recovering.
50 2021-01-05 anaphylactic reaction anaphylaxis; throat swelling; This is a spontaneous report from a contactable physician. A 50-year-o... Read more
anaphylaxis; throat swelling; This is a spontaneous report from a contactable physician. A 50-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension, lipids (as reported) and asthma. The patient was known allergies: codeine, iodine, shellfish, latex, and cefatrizine propyleneglycolate (CEFTIN). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in hospital. The patient experienced anaphylaxis and throat swelling on 22Dec2020 with outcome of recovered in Dec2020. The events were reported as non-serious. The events resulted in Emergency room/department or urgent care. Treatment of epinephrine, steroids, antihistamines, observation was received for the events. Information on lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis and throat swelling cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
50 2021-01-05 swelling face swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ w... Read more
swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ went down chills/fatigues soreness to injection site( which was excepted)
50 2021-01-05 swelling Patient stated after 15 minutes of getting vaccination and stated she felt like she felt light head... Read more
Patient stated after 15 minutes of getting vaccination and stated she felt like she felt light headed, felt like head and tongue were swollen, but they didn't appear to be swollen. Speech was clear. Treated with 25mg benadryl po and monitored for 45 minutes and patient stated symptoms resolved.
50 2021-01-05 white blood cell count increased Vaccinated 1510. Observed until 1530. at 1540 it was reported that she had chest tightness. no trou... Read more
Vaccinated 1510. Observed until 1530. at 1540 it was reported that she had chest tightness. no trouble breathing but substernal chest pain 8/10. Vital signs- Temp-97.9 Pulse-95 BP- 162/100 Resp- 22 oxygen saturation- 95 @ room air. 1600- transported to ER for evaluation and treatment.
50 2021-01-06 lymph node pain tinnitus, face tingling, lymph pain, general muscle pain
50 2021-01-06 swelling face warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u... Read more
warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u - stick neck, shoulder pain + heat, left cheek swollen been taking tylenol and benadryl saw PCP - received rx for prednisone
50 2021-01-07 anaphylactic reaction Anaphylaxis with a hives, itching, and airway involvement
50 2021-01-07 lymph node swelling Swollen Axillary Lymph Nodes up to the breast area.
50 2021-01-08 lymph node pain, lymph node swelling Swelling and pain under arms - no treatment (seemed to mostly subside when Celebrex was taken) Spot ... Read more
Swelling and pain under arms - no treatment (seemed to mostly subside when Celebrex was taken) Spot on tongue-no treatment still visible but no pain or irritation Other symptoms were expected and include injection site pain, heat rash likely from fever during the night but never had a recorded fever-subsided through day, fatigue, mild headache, overall just feeling like I was fighting a cold. (Viewed as immune response to me)
50 2021-01-08 peripheral swelling 01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and... Read more
01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and head congestion/sinus congestion, eyes hurt and bright red. 07:00am temp 99, took Tylenol 1000mg. 10:00am weakness and severe body aches and difficulty getting out of bed and almost fell several times and reported skin hurt. 2:57PM temp 102.7, took Tylenol 1000mg and Motrin 800mg , 06:00pm temp 100.4 took another 1000mg Tylenol and continued with symtpoms through the night and woke up around 3:30am 01/09/2021 soaking wet with sweat. 01/09/21 1:50pm continues with mild body aches and moderate headache.
50 2021-01-09 lymph node swelling Headache, Myalgia, Fever, Diaphoresis, swollen glands L>R Narrative:
50 2021-01-09 lymph node swelling After first shot notice a lump under my left armpit area. It didn?t quite go away and the after the ... Read more
After first shot notice a lump under my left armpit area. It didn?t quite go away and the after the second dose the lump got bigger and it?s a little tender this time. It?s been two days since the 2nd injection and doesn?t seem to be going down in size.
50 2021-01-09 swelling Low grade fever, large hard painful lump in right arm, achy joints
50 2021-01-10 lymph node swelling Headache, fatigue, lymph nodes inflamed, shoulders sore, runny nose, scratchy throat, resulted in ER... Read more
Headache, fatigue, lymph nodes inflamed, shoulders sore, runny nose, scratchy throat, resulted in ER visit.
50 2021-01-10 lymph node swelling lymphadenoma
50 2021-01-10 swelling, lymph node swelling Severe fatigue, joint pain and swelling, headache started on day after vaccine. Left arm pain at sit... Read more
Severe fatigue, joint pain and swelling, headache started on day after vaccine. Left arm pain at site of injection that progressed to L sided lymph node swelling on day after vaccine and has progressed to Left side lymph node swelling in L side of neck, axilla, Left side of breast, chest wall with pain still present and worsening 4 days after vaccine given (2nd dose)
50 2021-01-11 swelling Headache, Sedation, Myalgia, Arthralgia, Angioedema, Rash, Chills, fatigue, and tiredness Narrativ... Read more
Headache, Sedation, Myalgia, Arthralgia, Angioedema, Rash, Chills, fatigue, and tiredness Narrative:
50 2021-01-11 lymph node pain day 1: injection site pain, left neck/jaw area painful lymph node. After 24 hours: swollen lymph nod... Read more
day 1: injection site pain, left neck/jaw area painful lymph node. After 24 hours: swollen lymph nodes. At approximately 30 hours after injection - on face, neck, scalp - burning, blotchy, red rash (item 20 - recovered? yes to rash bcz I took Benadryl. lymph nodes still swollen)
50 2021-01-11 lymph node swelling not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she wa... Read more
not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she was hot and cold; dry throat; nausea; a little stomach upset; left arm was sore for several days too; Headache; muscle ache; joint pain; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable a 50-year-old female Registered Nurse reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 11:40 on Deltoid Left at single dose for covid-19 immunisation. Medical history included was none. There were no concomitant medications. The patient experienced headache, muscle ache, joint pain, left arm was sore for several days too on 17Dec2020; not feeling well, sore, runny nose, sore throat, swollen glands, sweats, chills, feeling like she was hot and cold, dry throat, nausea, a little stomach upset on an unknown date. The detail clinical course was provided as following: the nurse reported side effects and want to verify if side effects that "keep coming and going back every couple days" are "normal". Received first dose last 17Dec2020 and felt side effects on the evening. Returned on Monday last week, lasted until Friday, and back on 06Jan2021. The patient had developed a runny nose, sore throat, and feeling like she was hot and cold. She said she had sweats and chills, but no fever. She said she kept getting a warm sensation, and checked her temperature several times, but did not have a fever. She said she had a super dry throat, and her throat felt like a desert. She said she had swollen neck glands, clarifying the swollen neck glands were underneath her mandible. She said she had nausea, and a little stomach upset with no diarrhea. She said she was still not feeling well in her stomach. Reported last week she had 3 days with a nonstop headache, swollen glands, and a sore throat. She said the headache, swollen glands, and sore throat went away, but are back again, 06Jan2021. She said she was thinking what she was experiencing was more a side effect of the COVID-19 Vaccine than being ill because her symptoms went away and now were back. She said when a person was ill, the person got through the illness, and that was it, but her symptoms kept going away and coming back. Clarified the night of 17Dec2020, she had a headache and some muscle aches and joint pain, specifically in her neck. She said her left arm was sore for several days too. She said everything went away. She said she started feeling sick again last Tuesday, 29Dec2020, and felt ill through Friday, 01Jan2021. She said over the weekend she felt fine, and then on 06Jan2021, she was feeling ill with the same symptoms of a headache, sore throat, runny nose, and swollen glands. She said she thought it was odd that the symptoms came back again. She said maybe what she was experiencing were not side effects from the COVID-19 Vaccine, and she was ill. She said it was odd that she felt bad and then felt better, and then the symptoms come back again. Reported she can work through her symptoms, clarifying she had mild symptoms. The event outcome was unknown. All events were reported as non-serious. The events did not require a visit to: Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks): None. Relevant Tests: None. Treatment: Declined any Reported she was scheduled to get her second COVID-19 Vaccine dose on 07Jan2021. Information on the lot/ batch number has been requested.
50 2021-01-11 lymph node swelling Chills, body aches, terrible headache, nausea, tired for approximately 24 hours upon onset of sympto... Read more
Chills, body aches, terrible headache, nausea, tired for approximately 24 hours upon onset of symptoms Left axillary lymphadenopathy for approximately 3 days
50 2021-01-11 lymph node swelling Severe head pain, severe muscle pain, vomiting Fever 101.8, swollen right axillary lymph node
50 2021-01-12 lymph node swelling Chills, joint pain, fatigue the night of injection. The next day, my left underarm was swollen and s... Read more
Chills, joint pain, fatigue the night of injection. The next day, my left underarm was swollen and sore if I let my arm hang down at my side.
50 2021-01-12 swelling face Patient with warm feeling and swollen tongue day of vaccine, resolved tongue symptoms, now with resi... Read more
Patient with warm feeling and swollen tongue day of vaccine, resolved tongue symptoms, now with residual left cheek swelling.
50 2021-01-13 c-reactive protein increased HOSPITAL COURSE: Patient is a 50 y.o. female with a history of anxiety and migraine headaches who pr... Read more
HOSPITAL COURSE: Patient is a 50 y.o. female with a history of anxiety and migraine headaches who presented to hospital with cough and diarrhea. The patient had felt the symptoms on 12/31/2020 and eventually went to have a COVID test on 1/1/2021. She was subsequently positive but due to dehydration and diarrhea she came to the emergency department where she was admitted for remdesivir and dexamethasone. She was able to be weaned off any supplemental oxygen. Her diarrhea resolved. She is feeling well and will be discharged home in good condition.
50 2021-01-13 lymph node swelling Swollen lymph node warmth area fever pain
50 2021-01-13 lymph node swelling Two days after first vaccine, patient states that she experienced lymphadenopathy of left armpit. Re... Read more
Two days after first vaccine, patient states that she experienced lymphadenopathy of left armpit. Resolved without treatment after a week.
50 2021-01-13 peripheral swelling "I have had a headache and been fatigued for about 4 days along with what feels like cramps in my ar... Read more
"I have had a headache and been fatigued for about 4 days along with what feels like cramps in my arms and legs. My arm is red and lumped up but not as bad as it was second day. Also having cold chills as well."
50 2021-01-14 anaphylactic reaction We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on sta... Read more
We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on staff at the clinic and came in for her 1st dose of the Pfizer/BioNTech COVID vaccine. 10 minutes post-vaccination, patient started experiencing SOB, tingling fingers and face, and swelling of her lips and tongue. She moved herself outside to cooler air and then sent someone back inside to ask us for help. I ran outside with an EpiPen and immediately noted her pulse of 158 on her watch and she appeared to be experiencing an anaphylactic reaction. Patient stated she did not want to use the EpiPen but wanted to try chewing Benadryl instead first. I asked the staff for a blood pressure monitor and pulse oximeter. The 1st readings, approximately 12 minutes after vaccination, were HR 158, BP 155/105, and pulse ox 97%. Patient stated the Benadryl was working and her swelling was decreasing. The patient was not having trouble breathing at the time. I continued monitoring vitals and talking with the patient and approximately 20 minutes post-vaccination, she was improving (BP down to 134/80 and HR 120) but agreed we should call 911. She decided she wanted to move inside and lie down. I escorted her with support to a bed. Her vitals then increased again to BP 152/95 and HR 133 and her lips and tongue started swelling again. The patient appeared to be more labored in breathing then but still refused the EpiPen. Roughly 5 minutes after lying down, the medics showed up and took over and I went back to the vaccination area. I learned later that the patient refused to go to the hospital and after more observation was eventually allowed to leave with a friend/coworker driving her home.
50 2021-01-14 lymphatic obstruction Lymph edema; This is a spontaneous report from a contactable health care professional nurse, the pat... Read more
Lymph edema; This is a spontaneous report from a contactable health care professional nurse, the patient. A 50-years-old non-pregnant female patient (nurse) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; on 06Jan2021 as a single dose, for COVID-19 vaccination. Medical history included asthma, hypothyroidism and known allergy to penicillin. There were no concomitant medications. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 08Jan2021, The patient experienced lymph edema. No treatment was given for the event. The clinical outcome of lymph edema was not recovering. Information regarding lot number has been requested.
50 2021-01-14 swollen extremities 1/12/2021 @ 1045hrs - Received vaccine in left arm. 1/12/2021 @ 2200hrs - Vaccination site tendernes... Read more
1/12/2021 @ 1045hrs - Received vaccine in left arm. 1/12/2021 @ 2200hrs - Vaccination site tenderness, body/muscle aches. 1/12/2021 @ 2300hrs - Body/muscle aches, chills. 1/13/2021 @ 0300hrs - Body/muscle aches, chills, fever 99.0, general malaise. 1/13/2021 @ 0600hrs - Body/muscle aches, chills, general malaise, no energy. Did not report to work. 1/13/2021 @ 1000hrs - Symptoms continued. Took Advil 600mg PO. Slept from 1030-1230hrs. 1/13/2021 @ 1230hrs - No energy, very tired, rested the entire day. Took Advil 600mg every 4 to 6 hours. 1/13 to 1/15/2021 - Left arm site tenderness with raised, hard area at injection site. Left armpit soft tissue swelling, possibly lymphadenopathy. 1/15/2021 - Reported symptoms to provider, awaiting appointment.
50 2021-01-14 swelling old scar that I forgot that I have there, it just swelled up really bad; The injection site looked l... Read more
old scar that I forgot that I have there, it just swelled up really bad; The injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle; The injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle; The injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle; The injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle; Injection site began to itch; Injection site soreness; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142 (also reported as EL0140, pending clarification), expiry date: 03Mar2021 (also reported as 31Mar2021, pending clarification), intramuscular on the right arm on 08Jan2021 06:30 at a single dose for covid-19 immunisation. Medical history included heartburn, hot flashes, Grave's disease (father also has Grave's disease), had a thyroidectomy in Dec2015, menopause, weight loss, and appetite control, allergies, compromised immune status (brother and father side with autoimmune), respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, and diabetes type 2 diagnosed in 2019 (both parents and brother also with diabetes). Concomitant medications included levothyroxine sodium (SYNTHROID) in Dec2015 for Grave's disease and had a thyroidectomy, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) on 02Jan2021 for heartburn, phentermine for weight loss and appetite control, estradiol on 02Jan2021 for hot flashes and menopause, medroxyprogesterone acetate (PROVERA) on 02Jan2021 for hot flashes and menopause, prednisone for unexplained whelps (pending clarification), and cimicifuga racemosa (also reported as black cohosh) for hot flashes. The patient previously took metformin and experienced GI upset (she quit taking metformin/it was causing GI upset because they increased dose/current dose is 1,000mg twice daily increased from 500 mg twice daily) and generic levothyroxine sodium and experienced feels like crap. The patient had no previous history of immunization with the Pfizer vaccine. No additional vaccines administered on same date of the bnt162b2. No prior vaccinations within four weeks. The patient wanted to know if she can receive the second dose of the Covid vaccine after experiencing adverse events. On 08Jan2021, the patient experienced some injection site soreness, in which she took TYLENOL for. Around 14:30, she noticed that the injection site began to itch. Around 16:00, the injection site looked like "a small pox vaccine," in which appear red and scabby with a blue dot in the middle. The patient also reported, "scar that I have on my arm, it is not a reaction, it is an old scar that I forgot that I have there, it just swelled up really bad." Event injection site looked like a smallpox vaccine was assessed as serious-other medically important condition. No emergency room or physician's office required. Therapeutic measure was taken as a result of injection site soreness. Outcome of the event injection site looked like a smallpox vaccine was not recovered. Outcome of the events injection site soreness, injection site began to itch, vaccination site erythema, vaccination site scab, vaccination site discoloration, and old scar that I forgot that I have there, it just swelled up really bad was unknown.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event vaccination site discomfort cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
50 2021-01-15 peripheral swelling Swollen, painful, tender left deltoid Shaking chills Body aches, muscle aches, joint aches Fatigue, ... Read more
Swollen, painful, tender left deltoid Shaking chills Body aches, muscle aches, joint aches Fatigue, malaise
50 2021-01-17 swelling face SEVERE SWELLING OF LEFT EYE LID AND MILD SWELLING LEFT SIDE OF HER FACE. REDNESS.
50 2021-01-18 c-reactive protein increased Fever with chills and headache for atleast 4 days after 7 days of 2nd shot of Pfizer vaccine. No ac... Read more
Fever with chills and headache for atleast 4 days after 7 days of 2nd shot of Pfizer vaccine. No aches and pains or malaise or any respiratory symptoms. No immediate sideeefects at all. Negative for Covid and all labs except inflammatory markers like C-reactive protein and ESR elevated. Tested negative for the flu also. ESR 90, C-reactive protein 6.4.
50 2021-01-18 peripheral swelling Got vaccine at 11:30am. At 1:30p not feeling right, sweating, anxiousL hand swollen and tight, inj... Read more
Got vaccine at 11:30am. At 1:30p not feeling right, sweating, anxiousL hand swollen and tight, injection site looked normal. Assessed and was given Benadryl 50mg PO and lay down for an hour. Went home at 2:30p. Returned to work the next day and at noon felt feverish (100.0F), SOB, overall muscles ached and sore, injection site sore. My blood pressure was taken x 2 at 200/100 by nursing. I was driven to local ER and worked up. They could not determine if symptoms r/t to vaccine or not. My BP returned to normal. I was given a diagnosis of hypertension and a script for Lisinopril 5mg PO qd. I continue to have fluctuating high BP readings. My left hand swelling resolved. I plan to see my PCP as I have now s
50 2021-01-18 peripheral swelling Received vaccine at 11:30am. At 1:30p didn't feel well, noted that my left hand was swelling and fe... Read more
Received vaccine at 11:30am. At 1:30p didn't feel well, noted that my left hand was swelling and felt tight. The injection site looked OK. I was sweating and face was flushed. I was given Benadryl 50mg PO and lay down for an hour at work. I went home at 2:30p. The following day I went to work but at 12:00noon I was feverish (100.0F), dizzy, SOB, all-over sore muscles and my blood pressure was 200/100 taken twice by nurses at the facility. I was taken to the ER by car and had labs and work up in the ER. They were unable to determine if symptoms were vaccine related or not. I had taken first dose of hypothyroid medication on 1/14/21. They diagnosed hypertension and wrote me a script for Lisinopril 5mg PO daily. I continue to have high BP readings. My left arm at injection site is sore. The edema in my hand resolved the first day after the Benadryl dose.
50 2021-01-18 swelling face Patient reported an allergic reaction including hives and redness occurring 2 hours after receiving ... Read more
Patient reported an allergic reaction including hives and redness occurring 2 hours after receiving the vaccine. Patient reported face swelling, throat tightness, and slight difficulty of breathing later that same evening. Patient self treated with benadryl and her symptoms resolved.
50 2021-01-19 lymph node swelling, lymph node pain Swollen and very painful lymph nodes in neck, under arm, and upper chest swelling all on side of inj... Read more
Swollen and very painful lymph nodes in neck, under arm, and upper chest swelling all on side of injection. All accompanied by the usual fever, body, and joint aches which subsided at 48 hours after injection. Swollen and very painful lymph nodes in neck, under arm, and upper chest swelling still present.
50 2021-01-19 peripheral swelling 2-3 hours after the injection she began having joint achiness that progressed to body aches, fatigue... Read more
2-3 hours after the injection she began having joint achiness that progressed to body aches, fatigue and swelling in her hands and ankles. Symptoms were significant until 1/11/21 but have been improving.
50 2021-01-19 swelling face Delayed Localized allergic reaction. Approximately 24 hours after shot, I developed hives and swell... Read more
Delayed Localized allergic reaction. Approximately 24 hours after shot, I developed hives and swelling on cheeks, chin and swelling of lips. Immediately took 25mg of Benadryl. Sought treatment at an UTC for evaluation. I did not have trouble breathing and oxygen saturation was good, always above 97%. Upon reaching clinic 1 hour later, swelling and redness had gone down. Doctor diagnosed it as a localized allergic reaction to vaccine. I was given another 25mg of Benadryl and prescribed prednisone 20mg for 3 days. Swelling and redness has been intermittent since yesterday. All swelling and hives are confined to the face. I have been taking 50mg pf Benadry every 6-8 hours continuing this evening. It should be noted that I pre medicated with Benadryl the 2 nights before vaccination, the morning of, 1 hour after the shot and late evening the day I received the vaccine. I knew with my history of allergies I was at higher risk of allergic reaction. Please note the facial, eye and lip swelling began the following morning, 12 hours AFTER my last dose of Benadryl.
50 2021-01-20 lymph node swelling inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); ... Read more
inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); Temp 102; body aches; chills; lymph node in right armpit swelling sz golf ball; vertigo all lasted 2.5 days; migraine pain >10 on pain scale; rash on hands and arms; nausea; blurred vision; Ongoing headache and body aches 5 days now; This is a spontaneous report from a contactable Nurse (patient). A 50-year-old Female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 07Jan2020 at 09:00 a.m. intramuscular on right arm at single dose for COVID-19 immunization. Relevant medical history included hypothyroidism, post-traumatic stress disorder, anxiety and allergy to tetracycline. Concomitant medications included escitalopram oxalate (LEXAPRO), celecoxib (CELEBREX), levothyroxine, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]), colecalciferol (VITAMIN D [COLECALCIFEROL]) and paracetamol (TYLENOL). The patient received first dose of BNT162B2 on 18Dec2020 at 04:00p.m. intramuscular on right arm. On 07Jan2021 at 11:00 a.m. the patient experienced pyrexia with temperature of 102, body aches, chills, lymph node in right armpit swelling sz golf ball (as reported), nausea, migraine pain >10 on pain scale (as reported), rash on hands and arms, blurred vision and headache. On 08Jan2021 the patient underwent Nasal Swab SARS-CoV-2 test (Abbott) which resulted negative. No Treatment received for events. The patient recovered from vertigo on 09Jan2021. At the time of the reporting the patient had not yet recovered from headache and body aches, while was recovering from other reported events. Information about Lot/Batch number has been requested.
50 2021-01-20 swollen extremities, lymph node pain Large amount of edema under left armpit (size A cup) with very sore glands in same position.
50 2021-01-21 anaphylactic reaction Systemic: Anaphylaxis-Severe, Systemic: Seizure-Medium, Systemic: Tingling, tremors, convulsions, nu... Read more
Systemic: Anaphylaxis-Severe, Systemic: Seizure-Medium, Systemic: Tingling, tremors, convulsions, numbness and difficulty breathing -Medium
50 2021-01-21 peripheral swelling 3x2, red, hard, swollen, painful, itchy patch in arm
50 2021-01-22 swelling face, swelling, lymph node swelling Had swelling and lymph nodes in my neck, had face and neck swelling.
50 2021-01-24 lymph node swelling Typical sore arm right away. Next day, I felt something in my throat - like it was a lodged bone. Sh... Read more
Typical sore arm right away. Next day, I felt something in my throat - like it was a lodged bone. Short of breath and my heart was going faster than normal and short exertion. So I took an antihistamine - Allegra; tums; Tylenol; and took Prevacid. It didn't work. I was worried about my heart and that pressure on my throat. I went to my Dr. appt - she was able to get me in at short notice - and she examined me and did blood work and chest x-ray. Gave prednisone and albuterol . She said my lympyh nodes were swollen on my neck. Symptoms have resolved. And on second dose of vaccine I felt fine. But still have irregular heartbeat but I have a cardio appt coming up. I'm wearing heart monitor - Zeo - I mailed that on the 14 of January.
50 2021-01-24 swelling face Itchy face, tongue swelling, face swelling
50 2021-01-27 white blood cell count increased Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache t... Read more
Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache that would not be relieved with tylenol. I took a plane and arrived at 1130 pm. I went to bed shortly after arriving at my daughters house. Friday morning, I was unable to be woken up and my daughter called 911. I was in a coma. I suffered cardiac arrest during a CT to check for clots. I was resuscitated and put on life support. CT scan for clots, strokes, heart attacks were all clear. I was admitted to the C-ICU and on life support, on the ventilator, and was on 3 different medications at max dosage to keep my blood pressure barely surviving. The doctors told my daughter not to expect me to survive because they had no idea why I was suddenly so ill. A doctor then told my daughter that my kidneys were failing, and my liver was damaged. I also developed a high fever and had a high white blood cell count. They gave me Vancomycin and another antibiotic, and then the next the day a kidney doctor gave me lasix to flush out all of the excess fluid. I woke up on Saturday not knowing what had happened and was completely terrified and confused. My daughter was allowed into the ICU to see me and keep me calm, thankfully. She explained to me what happened. I am still in the hospital, as they are keeping me for observation and trying to determine if my kidneys will start working properly again. Prior to this, I have only ever had a kidney infection, and I thought before I might have had the start of a UTI. I do have chronic high blood pressure as well, a long term side effect from open heart surgery 10 years prior for an aneurysm, but aside from that I am relatively healthy 50 year old.
50 2021-01-28 axillary mass, lymph node swelling Woke up next morning with low grade fever, elevated heart rate, body aches, and sizable painful lump... Read more
Woke up next morning with low grade fever, elevated heart rate, body aches, and sizable painful lump swelling under arm that I got the shot in. Low grade fever resolved with motrin. Heart remained elevated for almost 48 hours. My resting heart rate is in the upper 50's. It was in the 90's during this time. Lump (swelling) under arm is getting smaller but still noticeably there 3 days later.
50 2021-01-28 peripheral swelling, lymph node swelling severe swollen lymph nodes to left arm pit ( injection arm); severe swollen lymph nodes to left arm ... Read more
severe swollen lymph nodes to left arm pit ( injection arm); severe swollen lymph nodes to left arm pit ( injection arm); developed very mild headache; severe chills; muscle aches; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient (pregnant: No) received second dose of bnt162b2 (lot number: EL1283), via an unspecified route of administration in left arm on 13Jan2021 07:45 at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included loratadine, progesterone, docosahexaenoic acid, eicosapentaenoic acid (OMEGA 3 FISH OIL), colecalciferol (D3), cyanocobalamin (B12). The patient previous received the first dose of bnt162b2 (lot number: EK5730), via an unspecified route of administration in left arm on 23Dec2020 06:00 AM for COVID-19 immunization. The patient experienced developed very mild headache on 13Jan2021 11:00, severe chills on 13Jan2021, muscle aches on 13Jan2021, severe swollen lymph nodes to left arm pit on 14Jan2021. The treatment paracetamol (TYLENOL) and ibuprofen (ADVIL) was used. The event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Approximate 4 hours post second vaccine dose, developed very mild headache, followed by, approximate 15 hours post second dose, severe chills, muscle aches, lasting about 8 hours, followed by, approximate 24 hours post second dose, severe swollen lymph nodes to left arm pit (injection arm), lasting approximate 24 hours. The outcome of events was resolved in Jan2021. Facility type vaccine: Hospital. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Not Known allergies.
50 2021-01-30 lymph node swelling Dec 18, 2020, 1st dose effect was just like flu-like symptoms; I just felt heaviness in my left shou... Read more
Dec 18, 2020, 1st dose effect was just like flu-like symptoms; I just felt heaviness in my left shoulder and a bit sore; I even proceeded to work after the shot and never thought that the effect of the 2nd dose is severe; Jan 6-8, 2021, (Wed-Fri) @ 11:00am - took covid vaccine 2nd dose, proceeded to work. @4:00pm - sent me home; felt the adversed reactions: left side weakness and numbness from shoulder to foot, fatigue, chills, headache; took naproxen as needed, helped somehow to ease the pain; chills were on and off; Jan. 9, 2021 (Sat ) - continuous monitoring, took Naproxen; No headache; Still present is left side weakness and numbness; new symptoms - sore/pain in left shoulder, swollen in and around left shoulder, underarm, chest and back; lymph node is also swollen and tender; chills in the evening; Jan 10 - continuous monitoring, symptoms still present with sore and pain, , taking naproxen as needed somehow helped when the med kicked in but pain?s back after the effect; Jan 11, took pain med, managed to go to work from 12:00nn continuous until 4:00pm; the pain got worsen, due to pushing and pulling of beds and wheelchairs with patients; I emailed the Covid19 Employee Health, CC'd to my Manager, informed them about my current condition and made PCP appt on Jan 15. Covid19 Employee Health replied in email with instructions to keep the appointment for Jan 15 and take covid test.. then my Manager sent me home. Jan 12, as per advice, took my Covid19 swab test, turned out Negative ; Jan 15, more pain and couldnt hold anything or even raise my left arm; in and around my left shoulder, chest, underarm and back are still swollen and tender. I went to my scheduled PCP appointment, they prescribed me Prednisone and Hydrocodone(PRN) for pain for 5 days and also recommended me to see a Specialist and a special test such as CT or MRI. If the pain doesnt go away, a follow up appointment was also advice. They are also expecting to send them paperworks related to this work injury/illness; Jan 18, continuous monitoring, sore and swelling still exist; emailed me saying that they been notified for my injury/illness report; In the link of the email, it said that they will send me the documents packet to be filled out and my PCP is also expecting for the papers but havent recieved yet; Jan 21, Yesterday was my 5th day of taking prednisone.. As of today, my left shoulder and around chest, underarm and back are still sore and swollen. The prednisone helped during the day but pain still present at night and when in bed. Some nights I hardly sleep even putting some pillows around.. During the day, I am trying to slowly raise my left arm holding it with my right hand and do some stretchings too. Despite all of these efforts, the progress is slow and pain is still exist. I sent an update to my PCP and to my Manager; My PCP sent me a reply saying that she would order for an Imaging but still waiting for the documents packet to be filled out and signed but havent received it yet. Jan 22, took pain med this morning, pain is just #5, but still hardly raise much of my left arm, still sore and swollen around my shoulder; chills and headace no longer present; i just experienced them on and off in my first 4 days after the 2nd dose; slowly raising my left arm with the help of my right hand; doing stretching too Jan 25, 2021. Today, I'm still out from work. my swollen left shoulder is subsiding but 'Im worried about the sore and swelling around it like in my chest, underarm and back. I can now raise my left arm but there is still pain, still weak and no grip. Yesterday, I got my claim number thru Portal and gladly received the hardcopy of the said docs packet on the mail today. I have also a follow-up appointment with my PCP tomorrow, 10:45am and hopefully will get an imaging order.
50 2021-02-01 lymph node swelling, lymph node pain left armpit and left breast lymph node swelling; left armpit and left breast lymph node swelling and... Read more
left armpit and left breast lymph node swelling; left armpit and left breast lymph node swelling and still hurting; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 15Jan2021 at 09:15 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history included the patient was a diabetic; penicillin, crustacean, rye, wheat and barley allergy; and COVID-19 diagnosed prior to the vaccination. Concomitant medications included metformin, atorvastatin, dapagliflozin propanediol monohydrate (FARXIGA) and an unspecified hormone replacement. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 15Jan2021 at 13:00, the patient experienced left armpit and left breast lymph node swelling, which was still hurting and swelling at the time of this report. The events resulted in a doctor or other healthcare professional visit. The patient was treated with ibuprofen (ADVIL) every 6-8 hours for pain. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of left armpit and left breast lymph node swelling and still hurting was not resolved at the time of this report. information on the lot/batch number has been requested.
50 2021-02-01 lymph node swelling Extreme body aches (muscles), Chills, tired, swollen and hard lymphoids, headache, nausea, pain in l... Read more
Extreme body aches (muscles), Chills, tired, swollen and hard lymphoids, headache, nausea, pain in lungs when breathing.
50 2021-02-01 lymph node swelling Received 2 doses of Pfizer vaccine, 2 weeks after second dose, started to have tachycardia, flushing... Read more
Received 2 doses of Pfizer vaccine, 2 weeks after second dose, started to have tachycardia, flushing, tremors, ina bility to take deep breaths. New diagnosis of Grave's disease and enlarged lymph nodes in chest.
50 2021-02-01 lymph node swelling On 1/17/21 at approximately 8:00 p.m., Patient noticed her lymph nodes were swollen on the left side... Read more
On 1/17/21 at approximately 8:00 p.m., Patient noticed her lymph nodes were swollen on the left side and she was unable to move her neck. She was better by 1/24/21
50 2021-02-01 lymph node swelling Adverse event: 2 of 7 people received a more concentrated dose of the vaccine. One vial of two was d... Read more
Adverse event: 2 of 7 people received a more concentrated dose of the vaccine. One vial of two was diluted incorrectly with less Normal Saline than require. This error was not noticed until person mixing vaccine said they were out of vaccine and did not have enough to get 5 dosages of 0.3ml. Two people mixed one vial of vaccine together demonstrating to the other. It appears the person making the error did not notice they did not have 1.8ml of NS but must have had some air and did not realize it. The error was noticed when all the vaccines were given and one person had not completed pulling up the vaccine. So, 2 of 7 patients received the incorrect dose of vaccine and it could not be determined which two received the incorrect dose. Patient reported next day of having swollen lymph nodes, soreness, chills, slight headache--
50 2021-02-01 swelling, lymph node swelling Next day following vaccine - lymph nodes in neck above clavicle swollen and soft tissue swollen. Th... Read more
Next day following vaccine - lymph nodes in neck above clavicle swollen and soft tissue swollen. The area below the clavicle- chest wall above left breast was swollen and tender. This has lasted going on a week and is starting to dissipate, but still there. Day after #2 vaccine I also had fever 100.5 for 12 hours, chills and headache. Brain fog for 2-3 days post vaccine
50 2021-02-01 swelling Developed rash & pruritus on neck w/ external swelling. Swelling & rash became worse, developed head... Read more
Developed rash & pruritus on neck w/ external swelling. Swelling & rash became worse, developed headache & neck pain. Took benadryl then saw MD. Started prednisone & hydrocortisone cream on 2/1/21.
50 2021-02-02 swollen extremities Hinchazón en el borde de la axila izquierda, dolor de cabeza, dolor en los huesos, fiebre, escalofr... Read more
Hinchazón en el borde de la axila izquierda, dolor de cabeza, dolor en los huesos, fiebre, escalofríos, sudoracion excesiva, dolor en parte baja de ambos pulmones.
50 2021-02-03 lymph node swelling SWOLLEN AXILLARY LYMPH NODE IN RIGHT ARM WHERE INJECTION WAS GIVEN
50 2021-02-03 peripheral swelling Swelling of forearm; trouble with movement in right hand; heaviness in same arm; Hives; itching; hea... Read more
Swelling of forearm; trouble with movement in right hand; heaviness in same arm; Hives; itching; headache that has turned into migraine.; headache that has turned into migraine.; This is a spontaneous report from a contactable other Healthcare Professional. A 50-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), intramuscular at right arm on 14Jan2021 13:00 at single dose for covid-19 immunization. Medical history included allergies to penicillin and sulfa. Concomitant medication included bupropion, propranolol, topiramate, sertraline, montelukast, alprazolam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the first dose of BNT162B2 (lot number: EL1284) on 27Dec2020 02:30 PM intramuscularly at right arm for covid-19 immunization. The patient experienced swelling of forearm, trouble with movement in right hand and heaviness in same arm. Hives, itching, headache that had turned into migraine. The symptoms started the day after the injection (15Jan2021). No treatment received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
50 2021-02-03 peripheral swelling her right hand is slightly swollen; Where she got the shot is a little red, warm, and swollen; Where... Read more
her right hand is slightly swollen; Where she got the shot is a little red, warm, and swollen; Where she got the shot is a little red, warm, and swollen; Where she got the shot is a little red, warm, and swollen; a little sore; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: 3248), via an unspecified route of administration in the right arm on 18Jan2021 at 08:40 A.M. (at the age of 50 -years-old) as a single dose, dose 2 for COVID-19 vaccination. Medical history was unknown. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), single dose, dose 1 in the left arm on 28Dec2020 and a flu vaccine on 29Aug2020. There were no concomitant medications. On 19Jan2021, the patient's right hand is slightly swollen. It was still mobile. She can move all digits. It was puffy and a little sore and where she got the shot was a little red, warm, and swollen. There were no relevant tests done. The patient had no emergency room or physician office visits. The clinical outcome of right hand is slightly swollen, puffy and a little sore and where she got the shot was a little red, warm, and swollen was not recovered.
50 2021-02-03 swelling face, swelling, oral herpes Headaches; pain/extreme body aches (worse than my fibromyalgia); a little difficulty to breath; extr... Read more
Headaches; pain/extreme body aches (worse than my fibromyalgia); a little difficulty to breath; extreme tiredness; swelling; woke up with my face swollen it went down after hot shower; Nauseous throughout the day; eyes burning; cold sores on my mouth; This is a spontaneous report from a contactable health care professional nurse, the patient. A 50-year-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3248), in the right arm on 19Jan2021 13:15 as a single dose, for COVID-19 vaccination. The vaccine was administered at a Public Health Clinic facility. Medical history included asthma, Fibromyalgia and known drug allergy to penicillin. Concomitant medication included diclofenac (DICLOFENAC), clonazepam (KLONOPIN). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 20:00, the patient experienced pain started at exactly 8:00pm; extreme body aches (worse than my fibromyalgia), a little difficulty to breath, extreme tiredness, swelling, woke up with my face swollen (it went down after hot shower). Nauseous throughout the day, eyes burning and cold sores on my mouth and Headaches. No treatment was received given for the event. The clinical outcome of pain, extreme body aches, difficulty to breath, extreme tiredness, swelling, face swollen, nauseous, eyes burning, cold sores on mouth and Headaches were recovering.
50 2021-02-03 white blood cell count increased Three weeks post vaccine I developed severe diffuse abdominal pain sending me to the emergency room.... Read more
Three weeks post vaccine I developed severe diffuse abdominal pain sending me to the emergency room. Work up revealed acute appendicitis and I was scheduled for emergency laparoscopic appendectomy the following day.
50 2021-02-04 peripheral swelling I started running a fever 101.8 and after 48 hours fever was gone. Swelling to my arm and my arm wa... Read more
I started running a fever 101.8 and after 48 hours fever was gone. Swelling to my arm and my arm was pink.
50 2021-02-04 white blood cell count increased ED COURSE / MEDICAL DECISION MAKING / TREATMENT PLAN: ED Course and Medical Decision Making: Patient... Read more
ED COURSE / MEDICAL DECISION MAKING / TREATMENT PLAN: ED Course and Medical Decision Making: Patient evaluated. Peripheral IV established labs obtained. I do have concern for adverse reaction secondary to the vaccine as her symptoms started she said shortly before an hour after receiving the vaccine is started with tingling in her tongue throat and her body. She has minimal cardiac risk factors. Given she was tachycardic she cannot be perked out. EKG obtained showed no acute ischemic ST elevation or depression. Initial troponin was not elevated. Patient received 500 mL bolus of normal saline she deceived Benadryl and part of Pepcid. While the Benadryl infusion was going on patient reported feeling lightheaded and her heart rate was noted to increase to the 130s briefly. The medications were stopped, the Benadryl had already finished however the Pepcid was not completed. Her heart rate proved quickly and the lightheadedness resolved. Repeat EKG obtained did show some mild ST depression inferiorly. A repeat troponin obtained at 2 hours remain negative D-dimer was elevated to 91 therefore CTA chest was obtained. This showed no evidence of pulmonary embolism there is small groundglass opacity left upper lobe which is likely related to atelectasis do not feel that this is infectious in etiology patient has not had cough fever or chills. She remained on cardiac monitor here without any further tachycardia and her symptoms had resolved. I do believe patient's presentation is secondary to adverse reaction to the vaccination. She was advised to take Benadryl at home and may also try over-the-counter Pepcid at home for her symptoms. Did not feel that steroids were warranted at this time. She is to follow-up closely with her primary care provider. I did advise if she has new or worsening symptoms she should return to the emergency department and she expressed understanding and agreement with this plan.
50 2021-02-05 peripheral swelling Bumps on finger, some swelling with pinkness around.
50 2021-02-08 peripheral swelling Pain, swelling, formation of large, red, warm, lump, and unable to lift arm. Took over the counter p... Read more
Pain, swelling, formation of large, red, warm, lump, and unable to lift arm. Took over the counter pain relievers, tried cold and warm compresses. Redness, warmth, and lump resolved after 3 weeks. Still will left arm pain. Painful to lift and abduct arm.
50 2021-02-09 lymph node swelling, peripheral swelling Swollen arm and swelling in armpit area size tennis ball. Tylenol. Day 3 and 4 post vaccine
50 2021-02-09 lymph node swelling Chills, slight fever, swollen lymph node (under left arm), body aches
50 2021-02-10 lymph node swelling, swelling face I experienced a hyper-reactive immune response after receving the first dose of COVID-19 vaccine on ... Read more
I experienced a hyper-reactive immune response after receving the first dose of COVID-19 vaccine on Friday 12/18/20. On Saturday, 12/19/20, I developed severe pharyngitis, swollen glands in my neck and jaw, blisters and ulcerations on my lips and area surrounding my mouth, intra-oral and buccal lesions, severe headache, photophobia and eye pain, myalgia, skin sensitivity, GI upset consisting of nausea and diarrhea, and lost my sense of taste and smell for 48 hours. I was not febrile. The symptoms were severe on 12/19 and 12/20, with improvement on Monday 12/21. I completed an event form with Pfizer documenting the hyper-reactivity.
50 2021-02-10 lymph node swelling Enlarged lymph nodes in axilla and by clavicle; headache, fatigue
50 2021-02-10 lymph node swelling Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmare... Read more
Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmares; euphoria; insomnia; waking up often red eye; Nasal Swab positive; Nasal Swab positive; This is a spontaneous report from a contactable nurse reported for herself. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot#Ek5730, on 28Dec2020 04:00 PM at single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. On 31Dec2020 the patient tested positive for the SARS-COV-2 virus (via nasal swab). The outcome of the event was unknown. On 27Jan2021 the patent experienced chills, lymph nodes swollen on chest, lump in throat, muscle aches pain at injection site, nightmares, euphoria, insomnia and waking up often red eye. The outcome of these events was reported as recovered and no treatment received. Lab data included Polymerase chain reaction: Positive on 31Dec2020.; Sender's Comments: Based on the current available information, the events Drug ineffective and COVID-19 are unlikely related to BNT162B2 vaccine. The events occurred 3 days after vaccination, when vaccine was not expected to achieve the effect. The case will be reassessed if additional information becomes available.
50 2021-02-10 lymph node swelling Enlarged lymph node; soreness above left clavicle; This is a spontaneous report from a contactable o... Read more
Enlarged lymph node; soreness above left clavicle; This is a spontaneous report from a contactable other health professional (patient). A 50-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 21Jan2021 08:00 at a single dose on left arm for COVID-19 immunization. The patient medical history were not reported. There were no concomitant medications. The patient previously took keflex [cefalexin monohydrate] and experienced allergies. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO142), via an unspecified route of administration on 31Dec2020 13:00 at a single dose on left arm for COVID-19 immunization. The patient experienced enlarged lymph node and soreness above left clavicle on 21Jan2021 20:00. No treatment received for the events. The outcome of the events was not recovered. The events were considered as non-serious. The patient was not pregnant. No other vaccines within 4 weeks prior to the COVID vaccine. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was at the Hospital. Information on the lot/batch number has been requested.
50 2021-02-10 lymph node swelling Left axillary lymphadenopathy
50 2021-02-10 peripheral swelling, lymph node swelling, lymph node pain Low grade fever began about 21 hours after shot. Very achy all over about 24 hours after shot. 36 ho... Read more
Low grade fever began about 21 hours after shot. Very achy all over about 24 hours after shot. 36 hours after shit the lymph nodes under my left arm began to swell and hurt. Over the course of the next 2-3 days after that, the nodes continued to swell and hurt down my arm past the elbow. A week after the shot it was all resolved
50 2021-02-10 peripheral swelling Fatigue for 12 days; severe pain to all joints especially knees and neck; severe pain to all joints ... Read more
Fatigue for 12 days; severe pain to all joints especially knees and neck; severe pain to all joints especially knees and neck; weakness; nausea; headache; feverish; swelling of left arm; malaise for 12 days; symptoms of pain lasted 12 days-I still don't feel 100%; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: e1 3246), via an unspecified route of administration at the left arm on 11Jan2021 at single dose for COVID-19 immunization. The vaccine was received in a nursing home. Medical history included seasonal allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 11Jan2021 04:00 PM, the patient experienced fatigue for 12 days, severe pain to all joints especially knees and neck, weakness, nausea, headache, feverish, swelling of left arm, malaise for 12 days, symptoms of pain lasted 12 days- I still don't feel 100%.The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. Events resulted to Doctor or other healthcare professional office/clinic visit. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 using Nasal Swab on 22Jan2021 and result was negative. The outcome of the events was recovering.
50 2021-02-10 peripheral swelling Arm burned from the inside out from injection site to finger immediately , walk to seat for obs sat ... Read more
Arm burned from the inside out from injection site to finger immediately , walk to seat for obs sat down immediately headache lump in throat then: tingling fingers , dizziness, swelling hands feet and face, flushed, turn bright & lump in throat bigger within 10 mins to the ER for treatment
50 2021-02-11 swelling reports fever blister within 1 hour that resolved and didn't require immediate treatment. next day d... Read more
reports fever blister within 1 hour that resolved and didn't require immediate treatment. next day developed myalgias but then came into the ED due to a feeling of tongue swelling and swelling of the neck, no n/v/d, no sob/wheezing/stridor
50 2021-02-12 lymph node swelling Vomiting, rigors, headache, left axillary lymphadenopathy and breast tenderness
50 2021-02-13 peripheral swelling Throat was a little swollen by the first nite. Second day had bump and red swollen rash on left arm ... Read more
Throat was a little swollen by the first nite. Second day had bump and red swollen rash on left arm size if silver dollar and by third day it had become a little larger and was itchy.
50 2021-02-14 swollen extremities swelling in L axilla hair loss swelling under L breast hives (happened after eating eggs, but never ... Read more
swelling in L axilla hair loss swelling under L breast hives (happened after eating eggs, but never had any history of egg allergy in the past)
50 2021-02-14 white blood cell count increased She received her 1st vaccine without any adverse or side effects. Within 30 seconds of her 2nd vacc... Read more
She received her 1st vaccine without any adverse or side effects. Within 30 seconds of her 2nd vaccine she became flushed, within minutes she developed hives starting on her hands and then becoming more generalized, as well as itchy palms. She also was hypertensive. The COVID vaccine clinic administered epinephrine and transfer her to the emergency department where she was given prednisone, Benadryl, and famotidine. ED notes do indicate she had some mild expiratory wheezing but on further discussion with her today this is a consistent finding after being diagnosed with asthma last year (more on this below). She was monitored for over 3 hours and discharged home. Her itching resolved in the ED, hives resolved about 3 hours after discharge and other symptoms resolved around 24 hours post vaccine. She did have labs drawn in the ED: troponin and C4 WNL. CBC showed leukocytosis with lymphocytosis and eosinophilia. No personal history of seasonal, perennial, food, or bee sting allergies; asthma history as below. She did have an episode of bilateral eye swelling in December that was evaluated by her PCP; she was treated with benadryl & prednisone and this took 3 days to resolve. She has no other history of anaphylaxis, hives or angioedema. She was able to show me pictures of this today.
50 2021-02-15 lymph node swelling Night of vaccine (2/13) headache and body ache; Morning after (2/14 am) site injection swollen, red,... Read more
Night of vaccine (2/13) headache and body ache; Morning after (2/14 am) site injection swollen, red, and hot. body was weak, headache; Night after (2/14 pm) nausea, headache, injection site swollen, hot to the touch, and red. lymph nodes swollen (right armpit); Two mornings after (2/15 am) throwing up (4 times), injection site more swollen, hot, swollen lymph nodes (right armpit), body was clammy; Two evenings after (2/15 pm) injection site swollen, hot, swollen lymph nodes (right armpit), body was clammy; Three mornings after (2/16 am) injection site swelling increased, red, hot, swollen lymph nodes (right armpit), redness line from site to right armpit into a red circle
50 2021-02-15 peripheral swelling I had the usual arm soreness. Foot pain started on 22nd and worse on 23rd. Left foot hurt the most. ... Read more
I had the usual arm soreness. Foot pain started on 22nd and worse on 23rd. Left foot hurt the most. This foot was the one that hurt a little before vaccine. It was in the center of my foot where the arch is but inside the foot - an achy pain. It would shoot through my foot with pain if I stepped a certain a way. I was limping a bit. I tried to stay off my feet as much as I could. It continued through Christmas holidays. December 28 -(my PCP) - she thought it was tendonitis - could see a red circle and swelling where most of the pain was. Dec 28 - x-ray of foot was done. There was no fractures Meloxicam - anti-inflammatory 15 mg daily starting 12/28/2020. Pain continued - trouble walking and started having hip pain and left leg pain maybe from compensating. I saw Dr. on January 7th. He said it was posterior tibialis tendonitis. He gave me a foot brace to wear - around ankle and foot. It helped but I was still having pain. I was still taking Meloxicam every day. A chiropractor and a physical therapist -they gave me foot exercises and leg exercises and that has been helpful - I see them once a week still. Dr check-up on February 9 and he ordered an MRI and I had that done on February 11th. Report says Tendinopathy and not tendonitis. I got the second dose on January 8th.
50 2021-02-16 lymph node swelling, lymph node pain After the first shot I just had a sore arm and nauseous for 4 days. After the second shot I had a s... Read more
After the first shot I just had a sore arm and nauseous for 4 days. After the second shot I had a sore arm (significantly more than after the 1st), had a massive headache for about 24 hours, but woke up this morning (2nd day after the shot) with swollen nymph nodes under my left arm along with pain and tenderness. It hurts to lift my arm or have anything putting any form of pressure on it.
50 2021-02-16 lymph node swelling Soreness in arm, extreme body aches, headache, low-grade fever, fatigue, Swelling in left armpit
50 2021-02-16 swelling face Flush face chest, swollen checks , lips, tongue, had issues talking
50 2021-02-17 c-reactive protein increased Please see weekly and daily updates. They are about 1 week behind timeline. Sxs started same day. Va... Read more
Please see weekly and daily updates. They are about 1 week behind timeline. Sxs started same day. Various sxs from high fever 103.1, body pains to complete spine, hips, various toes and left lower back over kidney felt sore.. Now shoulders hurt. Asked job for FMLA forms.
50 2021-02-18 anaphylactic reaction Patient with past medical history significant for anaphylaxis 2 months ago to iron infusion, receive... Read more
Patient with past medical history significant for anaphylaxis 2 months ago to iron infusion, received PCP clearance to receive COVID-19 vaccine. Patient given Pfizer vaccine # 1 (lot # EN6201). Approximately 12 minutes into 30 minute wait she began to report that she had a "sore/scratchy" throat and took Benadryl 50 mg PO (patients own supply). Patient took medication on her own and was given permission to take by NP. Patient was assessed by NP with breath sounds CTAB, no wheezing or stridor. No visible swelling of the lips, tongue or face. No rash. VS: B/P 124/73, HR 110, SaO2 100% on RA. During assessment she began to clear her throat and therefore was taken to Facility for further evaluation and monitoring. At Facility, pt was monitored for about 30 minutes. Pt admitted to be anxious about the vaccine. Pt received no medications from Facility. Pt instructed to use diphenhydramine Q6-8 hrs PRN. Pt was discharged to home.
50 2021-02-18 lymph node swelling 2/04/21, 1:00 PM, chilled "to the bone", temp of 101 degrees, very tired, nauseous - at 3PM took Adv... Read more
2/04/21, 1:00 PM, chilled "to the bone", temp of 101 degrees, very tired, nauseous - at 3PM took Advil and got a little relief - fever broke early morning of 2/05/21, remained nauseous for two days and exhausted for two weeks with brain fog Sore throat off and on, swollen glands off and on, occasional ear pain - this could be related to drainage, cause unknown 2/15/21 (about) sores began showing up - first two on the back of my left hand, then one on my left upper arm, today one on my right upper arm
50 2021-02-19 lymph node swelling Fever, Headache, Pain at injection site, Fatigue, Muscle pain, Chills, Joint pain, Injection site sw... Read more
Fever, Headache, Pain at injection site, Fatigue, Muscle pain, Chills, Joint pain, Injection site swelling and redness, Malaise, Lymphadenopathy
50 2021-02-22 swollen extremities Swelling at injection site leaving round circle that itches. Swelling under arm and tenderness in gl... Read more
Swelling at injection site leaving round circle that itches. Swelling under arm and tenderness in glands under arm. Muscle spasms in arms and chest. Slight nausea.
50 2021-02-22 peripheral swelling, swelling face Arm burning from the inside out from injection site right after injection; headache; tingling hand a... Read more
Arm burning from the inside out from injection site right after injection; headache; tingling hand and feet; swelling hands feet and face; swelling face; flushed; red all over wheel down to ED; lump in throat; Low blood pressure; high resting heart rate; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: e10140), via an unspecified route of administration at the left arm on 11Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included psoriatic arthritis, and allergies to shellfish, sulfa, bees, and, kiwi. The patient was not pregnant at the time of vaccination. Concomitant medication included naproxen sodium (ALEVE) and estradiol (ESTROGEN). The patient previously took naproxen (NAPROSYN) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm burning from the inside out from injection site right after injection on 11Jan2021 9:15. Seconds later the patient experienced headache, lump in throat, tingling hand and feet, swelling hands, feet, and face, flushed, red all over wheel down to Ed, low blood pressure, and high resting heart rate all on 11Jan2021. The events resulted in emergency room/department or urgent care. Treatment was received for the all the events reported as IV with added therapy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect product administration to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
50 2021-02-23 lymph node swelling Dull headache in back of head and back of neck rated 7/10. Bilateral swollen lymph nodes under arms.... Read more
Dull headache in back of head and back of neck rated 7/10. Bilateral swollen lymph nodes under arms. Swollen, soft, non tender
50 2021-02-24 peripheral swelling Painful joints - ankles, knees, hips, shoulder, elbows, wrists, and fingers Fatigue Painful swelling... Read more
Painful joints - ankles, knees, hips, shoulder, elbows, wrists, and fingers Fatigue Painful swelling of lower legs and ankles
50 2021-02-25 swelling face Salivary gland infection; Sjogren's syndrome (mouth inflammation); Sjogren's syndrome (mouth inflamm... Read more
Salivary gland infection; Sjogren's syndrome (mouth inflammation); Sjogren's syndrome (mouth inflammation); Lymph gland infection; Tooth disorder (rancid); Swelling in upper cheeks and ears; Swelling in upper cheeks and ears; Eyes are burning and a little bit dry; Eyes are burning and a little bit dry; Mouth really hurt to me; Flu; This is a spontaneous report from a contactable consumer reporting for herself. A 50-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# CL3302), via an unspecified route of administration, on 01Feb2021, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from Apr2020 to an unknown date, Sjogren's syndrome from 2015 and ongoing (was under control), fibromyalgia, autoimmune disorder, ongoing hormone level abnormal (taking estrogen), ongoing eye disorder. Concomitant medications included ongoing ciclosporin (RESTASIS) for eye disorder, famotidine (PEPCID), albuterol [salbutamol] (unknown manufacturer), ongoing estradiol (ESTROGEN) for hormone level abnormal. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation and experienced pain, asthma and nasal irritation. The patient experienced salivary gland infection (medically significant) in Feb2021 with outcome of unknown, Sjogren's syndrome (mouth inflammation) (medically significant) in Feb2021 with outcome of unknown, lymph gland infection in Feb2021 with outcome of unknown, tooth disorder (rancid) in Feb2021 with outcome of unknown, swelling in upper cheeks and ears in Feb2021 with outcome of unknown, eyes are burning and a little bit dry in Feb2021 with outcome of unknown, mouth really hurt to me in Feb2021 with outcome of unknown, flu in Feb2021 with outcome of unknown. The patient went to the emergency room for Sjogren's syndrome (mouth inflammation) and tooth disorder (rancid). On unknown date the patient underwent lab tests and procedures which included blood electrolytes: unknown results, full blood count: unknown results, investigation: unknown results, monocyte count: normal. Therapeutic measures were taken as a result of the events and included treatment with Salagen and Tylenol. The reporter stated she believed to have a reaction from the vaccine shot.
50 2021-02-26 peripheral swelling Injection site was bruise about 2 inches around and whole top arm was swollen and hard for 4 days. C... Read more
Injection site was bruise about 2 inches around and whole top arm was swollen and hard for 4 days. Could not raise arm without being in pain. Tired, headache behind the eyes, hard time breathing, chills (no fever) and dizziness. Still have headache and some dizziness and it has been a week and 2 days since the shot. Have not gone to the doctors. I have been treating myself with my inhalers and migraine medicine. Arm is better as far as soreness, but still have some bruising.
50 2021-02-28 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: All... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
50 2021-03-01 peripheral swelling dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purp... Read more
dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purple on the center of it; My legs were hurting like really heavy; I have not gone back to sleep and I feel like a bus hit me.; chills; the body ache; legs hurt really bad; fever; symptoms associated with the flu for a few days; feeling like really bad headache; nauseated; not feel so good; This is a spontaneous report from a contactable nurse. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiration date: unknown), via an unspecified route of administration from 28Jan2021 to 28Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure. Concomitant medication included verapamil for blood pressure. The patient received her first dose of BNT162B2 on 08Jan2021 and experienced arms a little sore. On 28Jan2021 at 18:00, the patient started feeling like really bad headache and then really nauseated. The patient took medicine and took Tylenol before went in to take her shot and started getting a headache again and not feel so good. On 29Jan2021 at 02:00, the patient stated that her legs were hurting like really heavy and had not been back to sleep since 2 o clock in the morning and she felt like a bus hit her. On 29Jan2021 at 11:00, the patient stated that her finger on the left side was numb and it has a little bit of purple on the center of it. On 29Jan2021, the patient experienced chills, body ache, her legs hurt really bad, fever, symptoms associated with the flu for a few days. On 30Jan2021, the patient experienced arm swollen. On 01Feb2021, the patient experienced dizziness and migraine. The patient already took Tylenol and ibuprofen. The outcome of the event chills, fever, flu symptoms, arm swollen was recovered on an unspecified date and the outcome of the other events was unknown.
50 2021-03-02 lymph node swelling, swelling "The shot itself was very unpleasant, the vaccine stung. The nurse was concerned about this since ... Read more
"The shot itself was very unpleasant, the vaccine stung. The nurse was concerned about this since it shouldn?t cause any discomfort at all. Other than immediate onset of a painful injection site no other symptoms occurred until later in the evening. I started feeling kind of yucky before I left work but nothing specific. By the early evening I was running a low grade fever and having muscle and joint pain. I didn?t sleep very well due to body aches and severe organ pain. At one point I woke up because my heart was beating so hard and fast I could feel it in my forehead. My lips and eyes were swollen and my neck was visibly swollen as well, I think due to the lymph nodes in my neck. My throat was some swollen but not enough to cause a breathing issue. The heartbeat issue didn?t last terribly long. I took a Benadryl to try and stop the reaction. I ran fever of a 102 give or take a few degrees either way for 2 ½ days. In addition, the injection site and whole shoulder area was swollen and hot with redness that wrapped around the front of my arm."
50 2021-03-02 lymph node swelling right cervical and axillary lymphadenopathy; This is a spontaneous report received from a contactabl... Read more
right cervical and axillary lymphadenopathy; This is a spontaneous report received from a contactable nurse (who is also the patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiry date: unknown), via an unspecified route of administration on the right arm, on 27Jan2021 13:15, at single dose, for COVID-19 immunization, at public health department. Medical history included hypertension (HTN), anxiety, depression, myalgia and penicillin allergy (PCN allergy). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Concomitant medication included losartan; hydrochlorothiazide, triamterene (MAXZIDE); cetirizine; colecalciferol (VITAMIN D); escitalopram oxalate (LEXAPRO). The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccination. On 29Jan2021, the patient experienced right cervical and axillary lymphadenopathy. No treatment was given for the event. The patient was recovering from the event. The reporter assessed the event as non-serious.
50 2021-03-02 peripheral swelling, lymph node swelling Arm soreness. This morning my armpit is very tender, sore and swollen. Very swollen in gland area. S... Read more
Arm soreness. This morning my armpit is very tender, sore and swollen. Very swollen in gland area. Soreness down my arm.
50 2021-03-03 lymph node swelling Patient reported a large fluid filled sac with a marble size lump. Patient reported she worsened fo... Read more
Patient reported a large fluid filled sac with a marble size lump. Patient reported she worsened for approximated 4 days then slowly started getting better. She massaged regularly to help lessen the size. At 3 week follow up, we were able to confirm she had a swollen lymph node surrounded by fluid filled sac. Patient was confident it was getting better. I advised to run this past a physician but felt it would be ok.
50 2021-03-04 swelling face Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recip... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recipient experience an allergic reaction. They reported throat closing. They were treated by EMS on site with methylprednisolone. Vaccine recipient took their own epinephrine and diphenhydramine. They were transported to emergency department. They reported with an allergic reaction and face swelling. They were administered famotidine. During reexamination, the patient?s symptoms improved and they were discharged to home. Registered 03/03/2021 10:38 AM, Discharged 03/03/2021 1:41 PM.
50 2021-03-05 axillary mass Appx 24 hours after the injection, the site of injection started itching very badly and a bright red... Read more
Appx 24 hours after the injection, the site of injection started itching very badly and a bright red solid spot appeared and a lump that was sore to touch. Redness was just smaller than a quarter at first. That was about 5:10pm 3/5 and then appx 8-9 hours later, while sleeping, I developed a severe cough and my nose was completely stopped up. Eyes were itching with drainage too. My husband got up and gave me a Benadryl and that calmed everything down so I could sleep again. This morning, my eyes were pretty red and still had some drainage. My cough is there but very faint and less frequent. My arm hasn?t stopped itching and the red spot is slightly larger at appx 1.5 inches tall and 1 inch wide. Still with a lump and soreness. I expected the lump and soreness.
50 2021-03-05 peripheral swelling Left shoulder is noticeable swollen and has noticeable pain. I have never had this kind of reaction ... Read more
Left shoulder is noticeable swollen and has noticeable pain. I have never had this kind of reaction when receiving flu shots. Fatigue, difficulty concentrating.
50 2021-03-07 lymph node swelling Swollen lymph nodes in neck and armpit and this morning started having severe pain in my left thumb/... Read more
Swollen lymph nodes in neck and armpit and this morning started having severe pain in my left thumb/wrist
50 2021-03-07 lymph node swelling Headache and fatigue the day after injection, lasted at least 24 hours. Sore arm at the injection si... Read more
Headache and fatigue the day after injection, lasted at least 24 hours. Sore arm at the injection site, the day of and up to at least 4 days after. Swollen lymph nodes under left arm (injection site arm) the day after and lasted at least 4 days.
50 2021-03-08 anaphylactic reaction anaphylaxis, treated with epinephrine,
50 2021-03-08 lymph node swelling Swollen lymph nodes in several places.
50 2021-03-08 peripheral swelling Left arm pain at site of injection, throbbing down the arm, burning sensation and heaviness. Inabil... Read more
Left arm pain at site of injection, throbbing down the arm, burning sensation and heaviness. Inability to raise arm and entire arm swollen. In addition to this on the first day of the adverse event flu like symptoms which lasted two days. Arm pain continues as at day four since adverse event started
50 2021-03-09 lymph node swelling joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection s... Read more
joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection site pain; malaise; muscle cramping; swollen lymph nodes; projectile vomiting; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN9581) via an unspecified route of administration in right arm on 03Feb2021 15:45 at single dose for covid-19 immunisation. Medical history included diabetes, hypertension (HTN), and gastrooesophageal reflux disease (GERD). Known allergies included xylometazoline hydrochloride (SUDAFED). Concomitant medication included omeprazole (PROTONIX), metformin hydrochloride, sitagliptin (JANUMET), empagliflozin (JARDIANCE), insulin glargine (BASAGLAR), escitalopram oxalate (LEXAPRO). There was no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient experienced joint pain, weakness, chills, diarrhea, dizziness, minor difficulty breathing, headache, injection site pain, malaise, muscle cramping, swollen lymph nodes, projectile vomiting, all on 04Feb2021 09:15 with outcome of recovering. No treatment received for the events.
50 2021-03-09 peripheral swelling Hands and feet swelling, Redness, Hives, Itchy Skin
50 2021-03-09 swelling face was fine at first then a little after 2 hours I started all of a sudden to get very light headed an... Read more
was fine at first then a little after 2 hours I started all of a sudden to get very light headed and dizzy....face felt very funny....swollen face and nausea along with slight fever and headache.
50 2021-03-10 lymph node pain, lymph node swelling On day 2 after vaccination I noticed generalized swelling under my left armpit & toward L breast. Sw... Read more
On day 2 after vaccination I noticed generalized swelling under my left armpit & toward L breast. Swollen & tender to touch. I am now on day 6 and swelling & tenderness r declining. On day 3 I noticed a swollen & tender lymph node on top of my L clavicle. One hour after my vaccination I had an issue with my vision that my eye doctor diagnosed as a visual migraine. I had never had one before.
50 2021-03-10 neck mass, swelling I have had major swelling above my collarbone between my shoulder and neck on the left side, the sam... Read more
I have had major swelling above my collarbone between my shoulder and neck on the left side, the same side as I received my shot. It is tender to the touch. After four days, I can feel harder masses inside.
50 2021-03-11 lymph node swelling, lymph node pain Post first vaccine L axillary lymphadenopathy. Post #2-L sub acute thyroiditis with difficulty swal... Read more
Post first vaccine L axillary lymphadenopathy. Post #2-L sub acute thyroiditis with difficulty swallowing, pain and significant lymph node swelling that became worse over a week.
50 2021-03-12 swelling 2/27/21 back of the neck started swelling, intestines gurgling, and a headache. 2/28/21 swelling to ... Read more
2/27/21 back of the neck started swelling, intestines gurgling, and a headache. 2/28/21 swelling to entire upper body and severe headache. Right front side a rib pushed out. Slept sitting straight up, could not put pressure on my spine at all. Spouse drove me to the chiropractor on 3/1/21 to have the rib adjusted. Six hours later my heart was literally pounding out of my chest for about a minute. Next day the swelling started to subside and can breathe again. Could lean back on my spine without any issues. Chiropractor on 3/3/21 and will go back next week. Intestines are still gurgling and 3/12/21 experienced diarrhea.
50 2021-03-13 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Medium
50 2021-03-14 lymph node swelling Swollen, sore armpit lymph node same arm as injection Chills, fever, body aches
50 2021-03-14 lymph node swelling Very large swollen lymph nodes in left armpit; neck, arm pain; neck, arm pain; headache; hot flashes... Read more
Very large swollen lymph nodes in left armpit; neck, arm pain; neck, arm pain; headache; hot flashes; low grade fever; This is a spontaneous report received from a contactable other healthcare professional (patient herself). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, formulation: Solution for injection and lot number: EL9265) via an unspecified route of administration on 03Feb2021 07:00 to Left arm at single dose for COVID-19 immunization. Patient medical history included Eosinophilia and colitis. Concomitant medications included Escitalopram, alprazolam and ibuprofen. Past drug included Wellbutrin and experienced allergy and first dose of BNT162B2 for COVID-19 immunization. On 03Feb2021 22:00 patient experienced Very large swollen lymph nodes in left armpit, neck, arm pain, headache, hot flashes, low grade fever still continues at 1 week after last dose. Seriousness was reported as non-serious. Patient did not receive any treatment for events. Outcome of events was not recovered. No follow-up attempts are possible. No further information was provided.
50 2021-03-14 peripheral swelling Immediately after receiving the injection, I experienced a headache right behind my eyes (similar to... Read more
Immediately after receiving the injection, I experienced a headache right behind my eyes (similar to sinus headache); after approximately 15 minutes, I experienced a ringing in my ears. I told the attending person, but she said it was probably due to being anxious about getting the shot. I left after being in the waiting area for 30 minutes and began driving home. My face felt very warm, so I opened the car window. I touched the side of my face and felt hives. My tongue felt thick, but I did not feel hives going down my throat. My torso started to itch and I had hives there as well. There was no raised area at the injection site. I became very itchy on my head, neck, and arms. When I arrived home, I took a dose of benadryl. Four hours later, I took a dose of zyrtec. My hives subsided and my tongue returned to normal, but I was still itchy. The next morning, I took a dose of claritin and called my doctor. In the afternoon, I took benadryl. In the evening, I took zyrtec. I continued this for 2 more days. The day after my vaccine, a node between my thumb and forefinger on my left hand was swollen and painful to the touch. My hand was swollen and my finger joints ached. I went to the doctor for an examination. The swelling and pain in my hand continued to worsen during the day and overnight. I kept ice packs on my hand and it felt better after 3 days.
50 2021-03-15 anaphylactic shock Thirty minutes after vaccination I went into anaphylactic shock. I kept clearing my throat and my ch... Read more
Thirty minutes after vaccination I went into anaphylactic shock. I kept clearing my throat and my chest felt really tight. I was really winded and the chest tightness got worse and my throat was closing. I was rushed to the ER and given IV Benadryl and Steroids with Oxygen and I was discharged after 3 hours. I was able to control it for the next few days with Benadryl. I still felt short of breath for the first three days and I still have headaches and since that event. I did not have any previous allergies before this event and had had the first dose of the vaccine.
50 2021-03-15 peripheral swelling 101 fever for 2 days now down to 99 fever very bad muscular pain for 2 days and still happening inte... Read more
101 fever for 2 days now down to 99 fever very bad muscular pain for 2 days and still happening intense headache unable to sit due to back pain could not sleep due to pain left underarm is VERY swollen
50 2021-03-15 swelling 20 minutes after vaccine injection Patient C/O tongue tingling, feeling swollen and puffy eyes. Pati... Read more
20 minutes after vaccine injection Patient C/O tongue tingling, feeling swollen and puffy eyes. Patient mildly swollen around eyes. VS Stable. IM Benadryl 50MG administered to right deltoid. O2 at 2L per NC administered. Improved for 10 minutes and then tingling and swelling returned. C/O of feeling lightheaded. Medicated with Epi pen to left thigh. Patient improved/stable and was sent via EMS to hospital for evaluation and treatment.
50 2021-03-16 lymph node swelling, lymph node pain Severe dizziness 1 hour after immunization, cleared after 1/2 hour. Starting day after vaccination,... Read more
Severe dizziness 1 hour after immunization, cleared after 1/2 hour. Starting day after vaccination, awoke with dizziness, nausea, chills. Diarrhea later in day. Starting 3 days after vaccine, painful and swollen and hard supraclavicular, Left axilla, cervical lymph nodes. Dizziness and nausea persist. Fatigue requiring 12 hours sleep. Paresthesias (tingling, "pins and needles"), both lower extremities, from toe to knee, unremitting, worst on day 2 after vaccination.
50 2021-03-18 lymph node swelling Swollen painful lymphnode under armpit.
50 2021-03-20 peripheral swelling A rash on my inner forearm near my wrists. It looked like tiny pinprick sized blood dots at first. N... Read more
A rash on my inner forearm near my wrists. It looked like tiny pinprick sized blood dots at first. Now it looks more like a traditional rash. Also a little swollen. I felt a wave of dizziness. That has passed.
50 2021-03-21 lymph node swelling Starting around 11 the night of vaccine, started getting jabbing pains in right armpit area, very sw... Read more
Starting around 11 the night of vaccine, started getting jabbing pains in right armpit area, very swollen lymph nodes and weakness in arm. Today is Monday and still hasn't subsided. Have been icing and taking ibuprofen every 4 to 6 hours. Left work early at 12:30.
50 2021-03-21 swelling collapse; respiratory distress; hypotension; tongue swelling; throat tightness; blood pressure abnor... Read more
collapse; respiratory distress; hypotension; tongue swelling; throat tightness; blood pressure abnormality; chest pain; increased swelling; skin changes; This is a spontaneous report from a non-contactable other hcp. A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration on an unspecified date) at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15 minute waiting period after the injection, the patient began to experience throat tightness. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, chest pain, collapse, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Treatment included: antihistamines. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A contributory role of vaccine BNT162B2 to the reported events cannot be excluded based on the plausible temporal relationship and product safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ehics Committees, and Investigators, as appropriate.
50 2021-03-22 lymph node inflammation Lymph notes all over my body are inflamed and tiredness (started 3/20/21 - the day after I received... Read more
Lymph notes all over my body are inflamed and tiredness (started 3/20/21 - the day after I received injection), and now COVID-arm (bruise at injection site, rash, pain) this started 3/22/21.
50 2021-03-22 lymph node swelling, axillary mass Swollen lymph nodes under my armpit. Once the swelling went down, I have two knots under my armpit ... Read more
Swollen lymph nodes under my armpit. Once the swelling went down, I have two knots under my armpit and a round patch on my right breast. I have regular mammograms once a year and I just completed one in October, 2020.
50 2021-03-22 peripheral swelling left ring finder tender on Monday 03/22/21, Woke up Tuesday, 03/23/21 finger swollen, as the day ha... Read more
left ring finder tender on Monday 03/22/21, Woke up Tuesday, 03/23/21 finger swollen, as the day has gone on it has gotten redder Called and spoke with a Teladoc doctor, said to take ibuprofen and ice, watch for 24/48 hours if gets redder or hot go and have it checked out for possible infection
50 2021-03-24 axillary mass After two days of fever and headache , I had some painful lumps on left underarm toward my left bre... Read more
After two days of fever and headache , I had some painful lumps on left underarm toward my left breast for three days. They disappeared for a couple of days and back again from yesterday. Its kind of burning in lumps with mild pain left side, arm, neck and back shoulder.
50 2021-03-24 swelling face evening around 4p.m. after the vaccine Adverse effect- lethargy, sleepy 03/23/21 felt cold, swollen... Read more
evening around 4p.m. after the vaccine Adverse effect- lethargy, sleepy 03/23/21 felt cold, swollen lip and face, lethargy, sleepy Ever have a reaction to a previous vaccine? If yes, what? no- usually gets 3 vaccines each month for allergies she didnt take the third dose this month because she was getting the COVID vaccine, area of injection usually gets swollen when she gets these vaccines and it goes away within a few hours Recommendations: please contact your PCP for recommendations since he has your medical records available, see what he recommends for you to take whether it be your prescribed allergy medication or any OTC items. If you are currently experiencing any Shortness of breath please visit your nearest Emergency Department, otherwise inform your PCP that you are experiencing swelling on your lips and that you experienced a swollen face that subsided. Consult with him on whether you should or shouldn't get the second dose vaccine, one of the contraindications for the vaccine is anaphylaxis so its better to take precaution.
50 2021-03-27 lymph node swelling Fever, body aches, chills, swelling of lymph nodes
50 2021-03-27 peripheral swelling Pain in left arm and running down into my fingers and joints - two weeks Pain on left side of my bod... Read more
Pain in left arm and running down into my fingers and joints - two weeks Pain on left side of my body 1-2 days All of my body ached 1-2 days Headache for a day or two (not extreme) Scratchy throat off and on for a few days Nauseous/ nothing sounded good to eat 3-5 days Upset stomach and rolling stomach with borderline diarrhea about 3 days Itchy all over (no rash at all) for a solid two weeks and now just occasionally Left hand and joints swelled slightly 2 weeks+ Tightness in chest 2 days and periodically for 2 days more
50 2021-03-28 lymph node swelling On Mar 26 I was achy and frigid. On Mar 27 I have poke up to a red rash on chest, face and neck, swo... Read more
On Mar 26 I was achy and frigid. On Mar 27 I have poke up to a red rash on chest, face and neck, swollen lymph nodes in throat, sore throat, and very large swollen lymph node in left arm pit. This lasted thru Sunday Mar 28. On Mar 29 I woke up to severe, frequent watery diarrhea and stomach gurgling along with burping and general gastro discomfort.
50 2021-03-28 lymph node swelling Pfizer-BioNTech COVID-19 Vaccine EUA Fever, chills, joint pain, muscle pain, nausea, swollen lymph n... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Fever, chills, joint pain, muscle pain, nausea, swollen lymph nodes, feeling unwell, tired, headache
50 2021-03-28 oral herpes was prescribed Valtrex and Zovirax same day which has caused the cold sores to subside; however, I s... Read more
was prescribed Valtrex and Zovirax same day which has caused the cold sores to subside; however, I still have issues with mouth ulcers
50 2021-03-28 swelling couldn't breathe or drive; heart throbbing in chest for a few minutes - very scary; front right rib ... Read more
couldn't breathe or drive; heart throbbing in chest for a few minutes - very scary; front right rib popped out; lack of appetite; swelling at back of neck/ entire upper body swelled up; intestines gurgling; headache/severe headache; Swelling in rib cage, collar bone; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9261, expiration date was unknown), via an unspecified route of administration, administered in the left arm on 12Feb2021 at 12:00 as a single dose for COVID-19 immunization. The vaccination facility type was reported as the public health clinic/facility. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiration date was unknown) on 22Jan2021 at 12:00 PM in the left arm at the age of 50 years, for COVID-19 immunization. Relevant medical history included Graves' disease from an unknown date and unknown if ongoing and had her thyroid removed on an unspecified date. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) for Graves' disease as she had her thyroid removed; levothyroxine sodium (SYNTHROID) for Graves' disease as she had her thyroid removed; and doxycycline taken for an unspecified indication; all start and stop date were not reported. The patient previously took codeine and had known allergy to this drug. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. The patient was not tested for Covid post vaccination. On 27Feb2021 at 06:00, the patient experienced swelling at back of neck, intestines gurgling, and headache. On 28Feb2021, the patient's entire upper body swelled up and her front right rib popped out; she had severe headache, lack of appetite, and slept sitting straight up as she could not put pressure on spine or lay down. On 01Mar2021, the patient's spouse took the patient to a chiropractor to adjust rib as she couldn't breathe or drive. Six (6) hours later on 01Mar2021, the patient experienced heart throbbing in chest for a few minutes - very scary. Swelling in rib cage, collar bone from an unspecified date in on Feb2021, and neck were subsiding by 11 pm. On 03Mar2021, the patient had her second chiropractic (chiro) visit to adjust neck. On 13Mar2021, gastronol was given for gurgling and the patient still had no appetite. The swelling was all better. The patient would need to go to the chiropractor about four more times to keep adjusting rib back in place. The adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all the events, which included chiropractic care for rib adjustment and gastronol. The patient recovered from the events "swelling at back of neck/ entire upper body swelled up and swelling in rib cage, collar bone" on an unspecified date, while the patient was not recovered from the rest of the events.
50 2021-03-29 lymph node swelling Headache, chest pain as pins and needles, shortness of breath, swollen throat, tounge, limpthotic no... Read more
Headache, chest pain as pins and needles, shortness of breath, swollen throat, tounge, limpthotic nodes, difficulty to breath and to swallow, weakness, disoriented, pain in body, difficulty to urinate, dizziness, blurry vision, nausea, tachardia, pulse rate increase, blood pressure increase, fatigue, body and muscle pain.
50 2021-03-29 lymph node swelling Itching at injection site (left arm); rash on left breast; rash on back (upper left side), swollen l... Read more
Itching at injection site (left arm); rash on left breast; rash on back (upper left side), swollen lymph nodes in left arm pit; bullseye around injection site (around 1 inch in diameter); sore throat; body aches; diagnosed with shingles on 3/24
50 2021-03-29 oral herpes The next day I developed what I thought was a cold sore around the top part of the right side of my ... Read more
The next day I developed what I thought was a cold sore around the top part of the right side of my lip, then 3 days after that I had a mild shingles outbreak on the right side of my face.,
50 2021-03-29 white blood cell count increased 3/29/2021 ERS Report: from Vaccination Clinic: Patient reported symptoms: Per ERS report: "Pt was ... Read more
3/29/2021 ERS Report: from Vaccination Clinic: Patient reported symptoms: Per ERS report: "Pt was walking to car after receiving her COVID-19 vaccine and a syncopal episode. Pt then had seizure like activity for approximately 1 min. Family states that she does have "stress seizures but is not on any anticonvulsants." Vital signs and blood sugar were assessed by onsite paramedic (AMR) and were within normal limits. Pt was then transported to hospital for further care." ED visit after Covid Vaccine 3/29/2021: HISTORY OF PRESENT ILLNESS: a 50 y.o. female who presents to the emergency department with history of bipolar and multiple psychiatric conditions including bipolar disorder. She presents today with episodes of ?seizure? and the desire to not speak to anybody. She has not been speaking to her husband since Friday and today while she was on the way out from getting a COVID vaccine fell to the floor and having shaking convulsing like episode. Husband states it lasted for 1 minutes and then resolved. He states that she has been unwilling to talk to him or medical staff and he does not know what is going on. He does affirm that she has been complaining about abdominal pain for the last 3 days and they did go to the hospital and have this worked up. He states that she has no known history of seizures and is not on any medications for this. CT head normal. Drug screen normal. Discharged to home.
50 2021-03-30 anaphylactic reaction Pt developed symptoms of anaphylaxis. Two doses of IM epinephrine were administered. 911 was called.... Read more
Pt developed symptoms of anaphylaxis. Two doses of IM epinephrine were administered. 911 was called. The patient was taken to the hospital via ambulance.
50 2021-03-30 lymph node swelling, lymph node pain Extremely swollen and painful lymph node under right arm
50 2021-03-30 lymph node swelling, peripheral swelling blood clots in arm/Blood Clots in Left Arm; swollen lymph nodes /Swollen Lymph Nodes in Left Arm; no... Read more
blood clots in arm/Blood Clots in Left Arm; swollen lymph nodes /Swollen Lymph Nodes in Left Arm; nodules were found on her lungs/Nodules in Lungs; arm swelling /Left Arm Swelling; Left Arm Redness; Left Arm Discomfort; Soreness at the Injection Site; This is a spontaneous report from a contactable consumer (Patient's Mother) calling on behalf of daughter. A 50-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date unknown), via an unspecified route of administration, administered in Arm Left on 05Mar2021 13:30 at age of 50 years old at single dose for covid-19 immunisation. There was no medical history. There were no concomitant medications. The patient did not have prior vaccinations within 4 weeks. No adverse events following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. The patient experienced the following after first dose. The patient experienced arm swelling /left arm swelling (hospitalization) on 09Mar2021 with outcome of recovering , blood clots in arm/blood clots in left arm (hospitalization) on 11Mar2021 with outcome of not recovered , swollen lymph nodes /swollen lymph nodes in left arm (hospitalization) on 11Mar2021 with outcome of not recovered , nodules were found on her lungs/nodules in lungs (hospitalization) on 11Mar2021 with outcome of unknown , soreness at the injection site on 05Mar2021 with outcome of not recovered , left arm discomfort on 08Mar2021 with outcome of not recovered , left arm redness on 09Mar2021 with outcome of not recovered. The patient was hospitalized from 11Mar2021 to 12Mar2021. On 05Mar2021 she began to have arm pain. 48 hours later, patient's arm started really hurting her, something about her arm being sore on the day of injection and reporter said she was going to be sore and when she got back from going away for the weekend, she thought uh oh, there was a problem here, this was not normal, not right. On 10Mar2021, she experienced swells arm swelling and went to urgent care which was diagnosed with swollen lymph nodes and given Cheplex prescription at urgent care. 11Mar2021, daughter was admitted to hospital by her provider. Daughter was found to have blood clots in arm and continued swollen lymph nodes. Daughter was given IV cheplex and Eliquis while in hospital. Daughter will have to be on Eliquis for next 3 months per reporter. The patient had her first vaccine, Pfizer, and became ill with blood clots, swollen lymph nodes, and wound up in the hospital. Reporter stated that she and the patient were worried about her getting the second shot. The patient was on blood thinners and was seeing a pulmonary doctor and hematologist. She didn't know about her getting the second shot and thought this should be reported. The patient was due for the second vaccine next week on 26Mar2021 and she was still sick, should it be postponed or what? The patient went the night before the hospitalization to the Urgent Care and the doctor prescribed Keflex, an antibiotic and saw her primary care doctor the next morning and she put her in the hospital. Reporter stated they were getting nervous and wanted to report for side effects. She stated the patient was home from the hospital but still sick really bad. The patient went to Urgent Care 10Mar2021, saw her primary care 11Mar2021 and was sent to the hospital 11Mar2021. Reporter later clarified that the patient was sent to the Emergency Room and after a few hours, she was sent upstairs to be admitted for a 24 hour hospital stay. The patient received Eliquis; Keflex as treatment. Fluids at the hospital, unknown type. Reporter stated they decided the patient wasn't doing really well and went to the Urgent Care that night and were given Keflex because they felt there was an infection. When they discovered it further that there were blood clots, the patient was told to stay on the antibiotic and given fluids and put on blood thinner, Eliquis, states patient had never been on a blood thinner before. Patient was admitted on 11Mar2021 for 24 hours. Reporter stated that they kept the medicine going and then felt she was stable enough to be discharged the next night at around 18:00 to continue with Keflex antibiotic and Eliquis for 3 months. Reporter stated they were told to contact a hematologist and pulmonary doctor for the nodules in her lungs and to contact her primary doctor if not doing better in one week, but they will probably contact her tomorrow. Reporter clarified that the patient had a chest x-ray a couple of months ago and everything appeared fine, so she thinks that the nodules developed after the vaccine. The patient had a chest x-ray on 11Mar2021 and nodules were found on her lungs, scheduled to follow up with lung doctor. Reporter stated whether they were there before or not was unknown. No follow up X ray yet. Reporter would like to know if daughter should get second dose? Second dose was scheduled 26Mar2021. Adverse events required visit to emergency room: Urgent Care the night before, follow up the next morning with primary doctor, the doctor got her in right away and said she needs to go to the hospital. Yes, patient went through the ER, doctor said that she would be coming and then after there a while, she was admitted to the hospital. Adverse events required visit to physician office. Patient saw the doctor on 11Mar2021 and was sent to the hospital. Information about lot/batch has been requested.
50 2021-03-30 lymph node swelling, swelling face Fever Chills Body ache Dry Cough Nasal Congestion Lymph nodes inflammation on the side of the injec... Read more
Fever Chills Body ache Dry Cough Nasal Congestion Lymph nodes inflammation on the side of the injection Tiredness Injection site pain Left cheek inflamation
50 2021-03-30 lymph node swelling I did not follow-up with the doctor as I slept for two days with difficulty. Severe allergic reacti... Read more
I did not follow-up with the doctor as I slept for two days with difficulty. Severe allergic reaction. My right side lymph node became severely swollen disrupting my ability to breath and very itchy. This lymph node on the front side of the neck was protruding making it difficult to swallow. Used breathing inhalers. Immediately leaving the vaccination site my temperature went high and I had to take off my shirt while I began to sweat profusely. When I arrive home I checked my temperature it would fluctuate between 98.6 and 101. My vision became extremely blurred for two days. I could barely see so I had to lay down and close my eyes and rest as I thought I was losing my vision. These symptoms were adverse while standing. General feeling of be unwell.
50 2021-03-30 lymph node swelling Grade 3 chills; body aches/pain; left underarm lymphnode swelling; This is a spontaneous report from... Read more
Grade 3 chills; body aches/pain; left underarm lymphnode swelling; This is a spontaneous report from a contactable other hcp (patient). A 50-years-old- non- pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: El9265, Expiration Date: unknown) via unspecified route administration in arm left on 08Feb2021 12:30 as a single dose for covid-19 immunisation. Medical history included allergies: PCN and first dose of covid vaccine received on 18Jan2021 at 12:00. Prior to the vaccination patient was not diagnosed with covid-19. Since the vaccination the patient had not been tested for Covid-19. The patient's concomitant medications were not reported. On 09Feb2021 at 02:00 the patient experienced Grade 3 chills, body aches, left underarm lymphnode swelling and pain. Patient had not been treatment for the adverse event. The outcome of the event was recovered.
50 2021-03-30 swelling face Under my eyes swelled up on both eyes. My face was red....it felt sunburned. I had welts on my in... Read more
Under my eyes swelled up on both eyes. My face was red....it felt sunburned. I had welts on my inner tighs and private area. Normal symptoms were sore arm and ache body. Bad headache
50 2021-03-30 swelling face Eye and face swelling. Sore muscles, fatigue
50 2021-03-31 lymph node swelling Headache- 48 hours Chills- 48 hours Fever- 12 hours Underarm pain (right side)- continuing- today is... Read more
Headache- 48 hours Chills- 48 hours Fever- 12 hours Underarm pain (right side)- continuing- today is day 5, I believe it is swollen lymph nodes. If not better I will go to Dr next week
50 2021-03-31 lymph node swelling Pfizer-BioNTech COVID-19 Vaccine EUA Swollen lymph nodes (under arm-size of a grapefruit) 3 days ras... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Swollen lymph nodes (under arm-size of a grapefruit) 3 days rash (2nd day) tiredness (3 days) nausea (3 days) body aches (3 days) injection site redness/swelling (one day)
50 2021-03-31 lymph node swelling In order, chills, nausea, severe vomiting, chest pain, shortness of breath, tingling in hands, heada... Read more
In order, chills, nausea, severe vomiting, chest pain, shortness of breath, tingling in hands, headache, fever, swelling under armpit of same arm vaccine received.
50 2021-03-31 oral herpes AERS completed because of being Tested positive for COVID-19 infection 14 or more days after being f... Read more
AERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:12/30/2020.pfizer Lot#EL0142 2nd dose:01/20/21.pfizerLot#EL3247 Diagnosed covid positive: 03/22/21 Exposure: Home Exposure Symptoms:Fatigue,insomia,cold sore, headache, chills, runny nose, loss of taste/smell
50 2021-03-31 peripheral swelling Noticeable swelling in left leg.
50 2021-04-01 lymph node swelling Swollen lymph node in underarm of left arm. Started shortly after 2nd dose of vaccine (Tuesday, 3/30... Read more
Swollen lymph node in underarm of left arm. Started shortly after 2nd dose of vaccine (Tuesday, 3/30/21) and is still present as of today (Friday, 4/2/21).
50 2021-04-01 lymph node swelling 1st dose 3/9/21- I received the injection at ~6:30pm & these symptoms began on 3/9/21 at ~ 8:30pm & ... Read more
1st dose 3/9/21- I received the injection at ~6:30pm & these symptoms began on 3/9/21 at ~ 8:30pm & lasted for ~24 hours after receiving the vaccine ?> Slight swelling & soreness at injection sight (right arm), low grade fever, tiredness, slight nausea 2nd dose 3/31/21 - I received the injection at ~12:35pm & these symptoms began on 3/31/21 at ~2:30pm & are ongoing as of this reporting on 4/2/21 ?> Tightness, large swelling, & extreme soreness at injection sight (left arm), extreme fatigue, headache, severe joint pain all over body, dizziness & feeling faint, severe stabbing pain in left side on back at shoulder blade that became worse with deep breathing or sitting upright, gland swelling on neck
50 2021-04-01 peripheral swelling Immediately after getting shot, I experienced the following: extreme drowsiness, dizziness, redness ... Read more
Immediately after getting shot, I experienced the following: extreme drowsiness, dizziness, redness all over, and feelings of being intoxicated?slow to speak hard to gather my thoughts. Was taken to ER and given Benadryl shot and another IV medication. While in ER both my hands swelled.
50 2021-04-01 swelling Tender/ soreness at injection site. Pain and swelling underarm area
50 2021-04-02 swelling Swelling, lump (larger than golf ball) , pain in the armpit
50 2021-04-02 swelling Pain at injections site, chills fever, intense back pain, swelling of back, headache
50 2021-04-03 lymph node swelling, lymph node pain Had very swollen lymph node on left side, bottom of neck, along my collar bone. Tender and sore, l... Read more
Had very swollen lymph node on left side, bottom of neck, along my collar bone. Tender and sore, like a pulled muscle but resolved itself within 36 hours. Very minor side effect, but wanted to report it for public health data gathering efforts.
50 2021-04-04 lymph node swelling Swollen and tender lymph node under left arm
50 2021-04-04 swelling My arm was sore by that evening. The next day, I got swelling in my armpit. There was no indention f... Read more
My arm was sore by that evening. The next day, I got swelling in my armpit. There was no indention from my armpit when I raised my arm. It looked different from other arm (completely). It was very swollen. No doctor visit. I took Advil after taking the pharmacist and she told me to take Advil. That helped with the swelling.
50 2021-04-05 c-reactive protein increased, peripheral swelling I could not work but my knees hurt so bad. I had an arthritis pain in my joints, wrist knee and my f... Read more
I could not work but my knees hurt so bad. I had an arthritis pain in my joints, wrist knee and my fingers. I was in a lot of pain and limping at the end of the day. I went to the ER and they did tests. A few days later I developed a rash on my thighs and when it started to spread to the other thigh. It looks like hives and it is was very itchy. The rash then appeared on my buttock and then to the other side. It proceeded to spread in patches in different areas of my body and then spread to the contralateral side of the same body area. I had swelling in my right hand on two fingers. A month after vaccination I also got a fever. All tests were negative except my CRP was elevated each time. I was prescribed Prednisone, but the rash still appears periodically, and my joints still hurt after 12 weeks. The rash is not as itchy when it appears. I have had another course of Prednisone after seeing the immunologist.
50 2021-04-05 lymph node swelling Swollen lymph nodes left armpit, pain along arm, some pain in jaw Extreme tiredness, lots of naps, b... Read more
Swollen lymph nodes left armpit, pain along arm, some pain in jaw Extreme tiredness, lots of naps, bit of brain fog
50 2021-04-06 lymph node pain, lymph node swelling IMMEDIATELY I started to get a headache which turned into a migraine that night. Migraine lasted 2 d... Read more
IMMEDIATELY I started to get a headache which turned into a migraine that night. Migraine lasted 2 days. within 24 hours i did get a low grade fever that only lasted less than 11 hours. 24 hours after I had a sore arm and my lymph nodes were swollen under my arm and near my collar bone. I was very sore in the lymph nodes area.
50 2021-04-06 lymph node swelling My left supraclavicular lymph node was swollen. I waited a couple of days and saw my doctor who thou... Read more
My left supraclavicular lymph node was swollen. I waited a couple of days and saw my doctor who thought it was related to the vaccine. It stayed swollen for a month.
50 2021-04-06 lymph node swelling Supraclavicular adenopathy, right sided
50 2021-04-06 lymph node swelling Swollen lymph node right side
50 2021-04-06 peripheral swelling Swelling of left arm, down to the wrist Swelling of the front and upper back, I couldn?t see my cla... Read more
Swelling of left arm, down to the wrist Swelling of the front and upper back, I couldn?t see my clavicle bones Stiff neck, left side only Skin felt tight, 10 minutes after receiving the immunization, like a bad sunburn Felt like there was something in my throat Body ache Headache Tiredness Nauseous
50 2021-04-07 lymph node swelling A rather large lymph node in my left arm pit was noticed the very next day after I received my secon... Read more
A rather large lymph node in my left arm pit was noticed the very next day after I received my second dose of the Pfizer COVID vaccine. This was not noticed after the first vaccine shot. Also I have experienced mild/moderate pain at injection site and general tiredness after both doses.
50 2021-04-07 swelling, neck mass Sore and swollen lump between neck/shoulder area.
50 2021-04-08 peripheral swelling pain and burning in injection site immediately that worsened. arm and hand swelling the point that h... Read more
pain and burning in injection site immediately that worsened. arm and hand swelling the point that her rings had to be cut off. difficulty moving arm due to swelling
50 2021-04-08 swelling, lymph node pain Severe arm pain in left arm, nausea, fatigue, rash, swelling, and pain under left arm
50 2021-04-09 axillary mass, swelling Pain Lump/swelling on neck (left side) Lump/swelling on Armpit (left hand) Constant pain
50 2021-04-09 lymph node pain Stiff neck; Lymph node pain; persistent pain on both sides of her back; Mild headache; Fatigue extre... Read more
Stiff neck; Lymph node pain; persistent pain on both sides of her back; Mild headache; Fatigue extreme; body was sore; bump at injection site that is sore; bump at injection site that is sore; Sleepiness; This is a spontaneous report received from a contactable consumer (patient). This 50-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN6198) via an unspecified route of administration on 08Mar2021 at about 21:00 (at the age of 50-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included vitamin D deficiency and hypothyroidism from about 4 years ago as of 2021, and morbidly obese. The patient had not had any other recent vaccinations. Concomitant medications included levothyroxine sodium (SYNTHROID) from at least 4 years ago or more as of 2021. On 09Mar2021, the patient experienced extreme fatigue, body was sore, at the place where the injection was there was a bump there that was sore, sleepy, and mild headache. On 10Mar2021, the patient experienced soreness, pain, and fatigue which were worse; everywhere on her body hurt, lymph nodes on the side and back of her head and down to her ear on both sides of her neck were hurting so bad; persistent pain on her back where her chest is, she didn't know what that was called, it was like someone punched her there on both sides. On an unspecified date the patient experienced sometimes she had a stiff neck that was new. The patient wanted to know if she should go to a doctor. The patient had blood work on an unspecified date with results of okay. The patient did not receive any treatment for the events. The outcomes of extreme fatigue, body was sore, at the place where the injection was there was a bump there that was sore, sleepy, mild headache, pain, lymph node pain, back pain, and stiff neck were unknown. No follow-up attempts are needed. No further information is expected.
50 2021-04-09 lymph node swelling, lymph node pain Rash on upper back and hives present constantly for 4 days starting 4 days after injection then int... Read more
Rash on upper back and hives present constantly for 4 days starting 4 days after injection then intermittent over first two weeks especially in evening. Had to get steroids After 1 week also noted swollen lymph nodes on entire right side of face sling jaw line up to temple extremely tender Unable to sleep for two weeks Finally got steroids again finishing now Nodes are still slightly tender and palpable entire body aching as well
50 2021-04-09 oral herpes Arm vaccine given swollen and red and hot, had fever 100-102 within hours for 5 days, joints hurt, s... Read more
Arm vaccine given swollen and red and hot, had fever 100-102 within hours for 5 days, joints hurt, shakes to point of not able to pick up glass of water, headache, extreme thirst, extreme tiredness and sleepy. I had vaccine on Wed. and had all of these symptoms until I stopped my Lithium Sunday and by Wed. I was feeling better. I drank as much water as I could and restarted my Lithium due to the side effects I had from stopping and I no vaccine issues today 4/9/2021 my issues from medication is starting to settle down. I only stopped the Lithium which is 600mg a day - I take 4 pills that are 150mg each.
50 2021-04-09 swelling face, swelling Left side of my face and entire tongue got pins & needles feeling about 17 minutes after shot. was g... Read more
Left side of my face and entire tongue got pins & needles feeling about 17 minutes after shot. was given a shot of Benadryl. For the next 4 days the sensation would repeat and I controlled it with Benadryl. My neck and face were swollen. The sensation also spread to left arm in the following days. Starting 4/7/21, the pins and needles feeling has returned to my left face. The swelling has never completely gone down on the left side of my face. The tingling is worse today and my body is itching.
50 2021-04-10 lymph node pain, lymph node swelling Very swollen and painful lymph nodes and tissue under arm. Very uncomfortable and I am now at day 8... Read more
Very swollen and painful lymph nodes and tissue under arm. Very uncomfortable and I am now at day 8 and it is not fully recovered.
50 2021-04-11 lymph node swelling Spleen is quite enlarged, I was informed this is not normal reaction from the Pharmacist I talked to... Read more
Spleen is quite enlarged, I was informed this is not normal reaction from the Pharmacist I talked to today, two days after vaccination day. ALL my lymph glands/nodes are quite swollen throughout my body!! Temp of 100.4 at its highest yesterday (Sunday, April 11th)! I have not had my spleen enlarge since the 1990's!
50 2021-04-11 lymph node swelling swollen lymph nodes in armpit of arm where the injection was given
50 2021-04-11 peripheral swelling Fatigue 3/31-4/7 headache 3/30-4/2 extreme achy muscles 4/1-4/5 Fever off and on 4/2-4/8 painful up... Read more
Fatigue 3/31-4/7 headache 3/30-4/2 extreme achy muscles 4/1-4/5 Fever off and on 4/2-4/8 painful upper arm and somewhat swollen 3/31-4/5
50 2021-04-12 swelling pt recieved vaccine at 1135 on 4/9, pt reported tongue swelling around 1130 the next day (4/10, 24 ... Read more
pt recieved vaccine at 1135 on 4/9, pt reported tongue swelling around 1130 the next day (4/10, 24 hrs after), presented to ED via EMS 1518, was diagnosed with angioedema likley due to ramipril, was intubated by 1624. pt had difficult intubation, was transferred to ICU, in critical condition on a ventilator, days later, after multiple cardiac arrests and multiple rounds of ACLS were performed, the pt was pronounced dead at 0127 on 4/12
50 2021-04-12 peripheral swelling, lymph node inflammation My first covid vaccine I had the chills and a 101 fever. My leg also swelled up and hurt from my lym... Read more
My first covid vaccine I had the chills and a 101 fever. My leg also swelled up and hurt from my lymphedema. My second shot I started a fever on 4-10 of 100.6. I also have the covid arm very swollen and red, itchy and painful. I feel my lymph node under my arm is tender and hurting too. Day 5 on april 13 and arm is still swollen.
50 2021-04-12 peripheral swelling Left hand ring finger and pinky swelling, bruising on pinky finger noted 7pm EST 4/8. Administered ... Read more
Left hand ring finger and pinky swelling, bruising on pinky finger noted 7pm EST 4/8. Administered 75mg Benadryl liquid, applied ice that evening 4/8, Administered 20mg loratidine and 1000mg Tylenol 4/9 am. Swelling resolved by 4/10, bruising resolved by 4/11. Restless leg 4/8 at bedtime. Left knee pain 4/9.
50 2021-04-12 peripheral swelling There were no side effects with the 1st dose. The 2nd dose resulted in the following: 4 hrs in: ... Read more
There were no side effects with the 1st dose. The 2nd dose resulted in the following: 4 hrs in: 2 hives on thigh 12 hrs in: More hives/welts on torso, feet, knees, elbows, hands, face, thighs 24 hrs in: fever, chills, body aches (expected) and extensive amount of welts, hives all over the body and swollen hands/feet, wrists/ankles to include itching and pain. The 2nd dose has triggered my Chronic Urticaria, which I first got in 2019 from what I believe was an ingredient in sunscreen (octinoxate). At that time it took me 1 long year to completely get rid of those hives and that was successful by using a series of prednisone (which was damaging to my system and hard to get off of) and then finally Xolair. I have not been off of the Xolair for even a year at this point and now, I am back to where I started. I believe that the PEGs in the Pfizer vaccine has activated my urticaria. I am now suffering with severe welts/hives and swollen hands. Prednisone is not an option due to it mixing with the vaccine and I managed to get a low dose of Xolair yesterday (4/12/21) but that shot is slow-absorbing and I might not see relief for 7-8 days. Additionally, my blood pressure was 160/100, which is consistent with presence of these welts/hives. This includes a rapid heart beat as well. Had I known this was a even a remote possibility, I would not have received the Pfizer vaccine. Chronic Hives is a life-altering issue as I have used a lot of sick time and missed events due to discomfort and swollen eyelids.
50 2021-04-12 peripheral swelling Within the first 5 minutes after the vaccination, I felt faint, lightheaded, dizzy, disillusioned, l... Read more
Within the first 5 minutes after the vaccination, I felt faint, lightheaded, dizzy, disillusioned, like I had vertigo also. I experienced these symptoms w/in the first 5 minutes once I left the designated vaccination area. My entire body felt hot, my face was red, I felt sweaty. I went to find a nurse nearby who walked me to an area to sit/rest so that she could monitor me. I did inform her that I had my EpiPen with me, however, she recommended that if I had Benadryl to take it immediately. She provided me w/water and I took one 25mg pill. She continuously took my pulse as I felt my heartbeat was fast, I had anxiety about the way I was feeling because I felt short of breath. While my throat/chest did not feel tight, I did feel a heaviness in my chest and my breathing was somewhat labored. My face became flushed and then pale/drained and I began to feel extremely nauseous w/in 10 minutes. The nurse continued to monitor/take my pulse/heart rate at this time. I did experience stomach cramps and had to go to the bathroom. I experienced diarrhea and continued to feel nauseous while in the bathroom. I continued to feel dizzy and just out of sorts so I was asked to remain at the hospital. I was asked if I'd like to be taken to the ER, however, I chose not to go to the emergency room because I did not want to incur any additional hospital charges if they were not going to utilize my EpiPen. I remained at Hospital vaccination clinic at the hospital for what I believe was approximately 2.5 hours. I did ultimately eat a small bag of pretzels and drank a small bottle of water. Thankfully, the Benadryl did help fairly quickly and tremendously to get me over the hump of symptoms and anxiety that I was feeling. Once I returned home, I literally just collapsed in bed and remained there basically sleeping for over the course of the next 48 hours. I followed a diet as my stomach was still upset. I did have a slight fever, but it did not get any higher than 99-100. I felt clammy the first day/evening, with subsequent chills, but ultimately, by Friday night and into Saturday, I felt well enough to get out of bed and move around the house. I felt back to some normalcy on Sunday. My left arm was swollen from Wednesday (day of vaccination) to Saturday. I could not lift my arm, or sleep on my left side due to the pain and I also couldn't lift my arm for approximately 48 hours.
50 2021-04-13 lymph node swelling, lymphatic obstruction Developed lymphadenopathy in left axilla that then developed into lymphedema in left arm. Also had w... Read more
Developed lymphadenopathy in left axilla that then developed into lymphedema in left arm. Also had weakness and pain in left arm. After 1 day also had lymphadenopathy and lymphedema in right arm. Had associated pain in bilateral hands, wrists, and forearms. Symptoms gradually resolved over 2 week time span.
50 2021-04-13 swollen extremities Pt came back to clinic after leaving with husband. States that she received vaccine and left and not... Read more
Pt came back to clinic after leaving with husband. States that she received vaccine and left and noticed edema to left arm, visible edema from left elbow to fingertips. Positive for brisk cap refill Positive distal pulses Denies numbness and tingling, denies pain. Edema or erythema to injection site Spontaneous improvement and continuous improvement at the clinic
50 2021-04-13 swelling face Second shot was given at 4:45pm; slight headache and sore arm around 8pm. Around midnight i was awa... Read more
Second shot was given at 4:45pm; slight headache and sore arm around 8pm. Around midnight i was awaken with my face twitching. More on my right side. This continued till about 4am. But I also felt pins and needles throughout my entire face. Around 3pm, i had swelling in my face to the point my eyes were close. Swelling got a tad better around 5am. Pins and needles continued till about 11am on 4/1/2021. I emailed primary doctor with a picture of my face. The nurse called me about 8am, and I told them that the swelling was going down. I was extremely tired since i was up all night....i went back to sleep and called the nurse office around 10am and said i was getting better.
50 2021-04-13 swelling face Swelling in face and throat
50 2021-04-14 lymph node pain, lymph node swelling swollen and tender lymph nodes chills fever low grade
50 2021-04-14 peripheral swelling ARM OF INJECTION IS STILL VERY SWOLLEN AND SORE. LOTS OF MUSCLE FUNCTION IN SITE ARM.
50 2021-04-14 white blood cell count increased 50 yo female with no medical history known to our system presents with Inferior STEMI with ventricul... Read more
50 yo female with no medical history known to our system presents with Inferior STEMI with ventricular fibrillation cardiac arrest. Unknown initial downtime without CPR. Arrived by rescue squad and taken emergently to Cardiac Catheterization Lab, required mid-LAD stenting. Therapeutic temperature management (TTM), now rewarmed. Currently intubated on mechanical ventilation, on norepinephrine, poor neurological responses, consider neurology consult for brain evaluation/prognostic recommendations. There is a progress note written by ED RN on 4/12/21 that states family reports she had "her 2nd COVID shot 1 week ago," but per Immunization Registry, only 1 COVID vaccine is recorded.
50 2021-04-15 lymph node swelling swollen, painful lump under left armpit
50 2021-04-15 lymph node swelling Arm soreness Swollen lymphnodes under arms Fibromyalgoa like symptoms that wrap around my chest and... Read more
Arm soreness Swollen lymphnodes under arms Fibromyalgoa like symptoms that wrap around my chest and back.
50 2021-04-15 oral herpes, swelling face Day 1: 3PM Sore throat, 11PM facial swelling, 4AM panic attack Day 2: 2PM, lasting for 3+ hours: N... Read more
Day 1: 3PM Sore throat, 11PM facial swelling, 4AM panic attack Day 2: 2PM, lasting for 3+ hours: Nausea, dizzy/faint/weakness, rapid heart rate (120-150 BPM), elevated blood pressure, chest pain and pressure, bronchoconstriction, pharyngeal constriction, sore throat, burning tongue, tinnitus ; 5PM chills, temp up to 101.5, intense lower back pain, headache, anxiety Day 3: intense headache, lower back pain Day 4: Mild headache, depression and fever blister later in the day Day 5: Deep depression, feeling of impending doom Days 6-16: Elevated anxiety, chest pain and pressure, bronchoconstriction, pharyngeal constriction, sore throat, burning tongue, tinnitus, GERD, esophageal spasms
50 2021-04-15 peripheral swelling Patient received her first dose Of Covid19 9 Pfizer-Biontech) on 03/26/2021 at 05:27pm.It was admini... Read more
Patient received her first dose Of Covid19 9 Pfizer-Biontech) on 03/26/2021 at 05:27pm.It was administered on her left arm , deltoid area. Her temperature at the time of injection was 96F. She stated she didn't experience anything until 2 days after the vaccination. She felt a swelling under her left arm , closer to her left breast. it was tender to the touch and painful to the touch. She also experinced swelling of her extremities.She looked up the symptoms online and it was reported as a side effect to Covid vaccine ( pfizer ) The swelling subsided after 2 days. She felt okay otherwise. She returned today and received her second dose.advised her to make an appt with her doctor and request evaluation from a medical proffesional.
50 2021-04-15 peripheral swelling Arm swelling, numbness/tingling, stiff in joints
50 2021-04-16 lymph node swelling Swollen tender lymph node in upper neck (under chin) on right side.; This is a spontaneous report fr... Read more
Swollen tender lymph node in upper neck (under chin) on right side.; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 10:30 (Lot Number: EL3247), at the age of 50-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included Hypertension, hypothyroidism, elevated platelets. The patient did not have COVID-19 prior vaccination. The patient previously took prednisone and experienced fast heart rate. Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX) taken for an unspecified indication from 25Jan2021 to 25Jan2021; irbesartan taken for an unspecified indication, start and stop date were not reported; amlodipine besylate taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium taken for an unspecified indication, start and stop date were not reported. The patient experienced swollen tender lymph node in upper neck (under chin) on right side on 13Feb2021 14:00 with outcome of not recovered. No treatment was given for the event. The patient has not been tested for COVID-19 post vaccination.
50 2021-04-16 swelling Noticed of redness swelling hive-like area around 5 a.m. this morning. That area has grown in size o... Read more
Noticed of redness swelling hive-like area around 5 a.m. this morning. That area has grown in size over the day. It is warm to the touch. It does not see him in the last couple of hours that it is getting any larger. When I noticed it this morning it was also tender to the touch that remains but it has been tender since I got my injection on Wednesday. The tenderness has progressed in size as with the hive- like swelling. It's now about the size of a a small orange. Prior to this morning or late last night did not know this any redness or swelling . The previous tenderness to touch was approximately about the size of a quarter with a small bruise.
50 2021-04-17 lymph node swelling, lymph node pain First dose: March 25, 2021 On April 9 I began to have dizziness and feeling as if the room was spin... Read more
First dose: March 25, 2021 On April 9 I began to have dizziness and feeling as if the room was spinning. I also had a feeling of tiredness and upset stomach. No vomiting and no fever. I had all of the classic symptoms of Benign Paroxysmal Positional Vertigo. By April 13, I had only a slight feeling of light-headiness and by April 15, I felt fine. I have never had vertigo before. Second dose: April 16 As of April 17 I have swollen lymph nodes under my left arm toward my left breast. The area is tender but is mostly felt during movement. I will be applying warm compresses to see if that makes a difference.
50 2021-04-17 lymph node swelling Swollen lymph node under arm are left side; hot flashes and teeth aching on left side
50 2021-04-17 peripheral swelling More swelling in left hand; Increase in joint pain; Common cold symptoms; Right ear felt weird; Incr... Read more
More swelling in left hand; Increase in joint pain; Common cold symptoms; Right ear felt weird; Increase blood pressure within 15minutes of the injection; This is a spontaneous report received from a contactable consumer (reporting on herself). A 50-years-old Non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration in Arm Right on 23Mar2021 16:15, as SINGLE DOSE for covid-19 immunization. Medical history included rheumatoid arthritis, hypothyroidism, hypertension all from an unknown date and unknown if ongoing. Concomitant medication(s) included prednisone (PREDNISONE) and meloxicam (MELOXICAM) both taken for an unspecified indication, start and stop date were not reported. The historical vaccine includes flu vaccine on an unspecified date. Patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 23-MAR-2021 18:00, more swelling in left hand, increase in joint pain, common cold symptoms, increase blood pressure Within 15minutes of the injection. Right ear felt weird. Patient was not received any treatment for the adverse reactions. Since the vaccination, patient was not tested for COVID-19. The outcome of the events recovered with sequelae. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
50 2021-04-18 peripheral swelling Patient received her 1st dose of Pfizer COVID vaccine on 02/26/2021. She noted some wheezing and sl... Read more
Patient received her 1st dose of Pfizer COVID vaccine on 02/26/2021. She noted some wheezing and slight shortness of breath and shared this information with her PCP at her regularly scheduled visit on 03/01/2021. PCP refilled inhaler at that time. Her shortness of breath progressively worsened, and she was seen by another provider as a walk-in at the office of her PCP on 03/13/2021. At that time, she was prescribed prednisone for 5 days, noting some improvement after a few days. She received her 2nd Pfizer COVID vaccine on 03/19/2021. The patient woke up on the morning of 03/20/21 with a swollen and painful leg and by 03/22/21 called PCP and was seen in the office. PCP ordered D-Dimer and LE ultrasound. Per the patient, the D-dimer was abnormal and the LE U/S showed a blood clot. PCP sent the patient to the ER, where a chest CT was ordered and showed a pulmonary emobolus. She was admitted overnight and started on Eliquis, and discharged the next day after seeing a hematologist.
50 2021-04-19 lymph node swelling The lymph nodes on my left side, by my collarbone and neck became swollen and sore. My entire collar... Read more
The lymph nodes on my left side, by my collarbone and neck became swollen and sore. My entire collarbone and neck area on left side is very sore to touch.
50 2021-04-20 lymph node swelling Vertigo and swollen glands in throat
50 2021-04-20 lymph node swelling On the night of the vaccine, my Lymph nodes below left, right ears and neck area swelled with a ras... Read more
On the night of the vaccine, my Lymph nodes below left, right ears and neck area swelled with a rash. My throat was burning as if I swallowed fire. This sensation still lingers. On 4/6/21 I woke up with pain on the left side of my neck to discover a small lump the size of the top and eraser. Today, 4/21/21 the lump is wider and I now have 2. My throat is still sensitive.
50 2021-04-21 lymph node swelling *4/4 Morning felt like I couldn't walk, knew my feet were their, but couldn't register to move for h... Read more
*4/4 Morning felt like I couldn't walk, knew my feet were their, but couldn't register to move for hr and then got up, EXTREME pain in center of my left armpit (to point of almost crying and it was worse than my kidney stone pain I had for a week) and all over pain in body-hard to even move much this day...I slept in 12 hr increments till next day. Noticed my Heart rate was very high constantly between 100-115 ( on my wrist monitor) * On 4/5 Woke up and told myself to get moving for day, arm was turning very red at this point and swelling bad along with armpit along edge and was hot and still painful. Was up for 7 hr.. I got in shower that evening and felt weird midway and my head felt like a whoosh and thought I was going to pass out (normal temp in shower) held onto shower got out was fine for about 20 min and then I started extreme shaking uncontrollably and teeth were chattering from chills. Went to get a Tylenol because I knew something was not right and within 30 min started sweating profusely with fever (I didn't even get up because I felt so crappy) *4/6 Woke up, felt a little better, arm, armpit and side of armpit red, hot and swollen still. Was up for 9 hrs, but when I went to bed and laid down, I felt like I couldn't breathe well...something told me to take a deep breath and I felt something like a pop in chest and then I felt like I was breathing better. Was not still feeling good on 4/7 but went back to work, on 4/8 felt a lot better, then woke 4/9 with Migraine and felt terrible and my heart felt weird...I called the Health Department and asked what to do and they recommended going to doctor... but a Nurse followed up with me which was very nice. Went to doctor and my Blood Pressure was 179/98 at that time. They ran blood work and prescribed me a antibiotic for my arm and armpit area. I want to add as well, not sure if this matters, but my shot was not in center of arm...it was closer to inner part of upper shoulder closer to chest.
50 2021-04-22 lymph node pain Chills, 102 fever, jack-hammering headaches, body aches, chest pain, dizziness, plugged ears, stiff ... Read more
Chills, 102 fever, jack-hammering headaches, body aches, chest pain, dizziness, plugged ears, stiff harm, sore lymph nodes. All finally went away after day 5 except still have chest pains.
50 2021-04-22 lymph node swelling painfully and visibly swollen lymph nodes in left collar bone, headache, nausea, soreness, fatigue
50 2021-04-22 lymph node swelling 4d later with right sided submandibular & parotid gland swelling to face with fever up to 100F
50 2021-04-22 peripheral swelling, lymph node swelling Blurry vision/Nausea/Dizziness/Extreme Fatigue/Dry Mouth/Swollen Lymph nodes under injection arm/ wi... Read more
Blurry vision/Nausea/Dizziness/Extreme Fatigue/Dry Mouth/Swollen Lymph nodes under injection arm/ widespread body aches/eye twitch right eye/facial numbness/swollen hands/weakness(difficulty getting out of bed) Currently on day 5 and showing marked improvement in most areas. Still some fatigue/weakness, swollen hands, and eye twitch/facial numbness but much better than previous days. Never had fever or significant headache like many have reported.
50 2021-04-22 swelling face Dizziness, rolling pain throughout the body, cold sweats, fever, nausea for approximately 15 hours. ... Read more
Dizziness, rolling pain throughout the body, cold sweats, fever, nausea for approximately 15 hours. Approximately a few hours later that same day facial pain on the right side of the face became swollen around the eye and check. The swelling lasted approximately 30 hours before subsiding.
50 2021-04-22 swelling ?Pfizer-BioNTech COVID-19 Vaccine EUA: patient present to clinic staing one day after vaccination ex... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA: patient present to clinic staing one day after vaccination experienced swollen, purple, and burning lips. Patient administered diphenhdramine and symptoms resolved over 1-2 days. Patient also reports nausea, decreased appetite. diarrhea, body aches, and frequent urination. Patient denies shortness of breath or fever. Patient advised to continue home management.
50 2021-04-22 swelling After 15 hours, felt rundown. Then fever started 2 hours later. Fever increased until (worst was 11p... Read more
After 15 hours, felt rundown. Then fever started 2 hours later. Fever increased until (worst was 11pm-2am ) it hit 102 F then took Tylenol. Fever was down to 101 by 6am and likely gone by 8am. Then hours of below temperature (only checked twice, had 96 then now 97.5). I didn't have much swelling at all and barely any pain at injection site.
50 2021-04-23 swollen extremities 4/16/21 Second Dose received. 4/17 and 4/18 noticed light swelling in ankles. No other effects. 4... Read more
4/16/21 Second Dose received. 4/17 and 4/18 noticed light swelling in ankles. No other effects. 4/19 - Emailed my Cardiologist about swollen ankles. Didn?t think about the vaccine as a potential cause. He scheduled an Echocardiogram for May. 4/20 to 4/22 - Edema is ankles and lower legs with pain on bottom left. Tried heat and elevation with no relief. 4/23 - Called Advice Nurse with recommendation to go to ER. ER determined a blood clot in left leg at the left posterior tibial vein measured at 6.3cm.
50 2021-04-24 lymph node pain high of 102 degree fever; Sever chills 1-4 am post vaccine; Woke up drenched several times; Muscles ... Read more
high of 102 degree fever; Sever chills 1-4 am post vaccine; Woke up drenched several times; Muscles felt like she's been shocked with high voltage; Tingling pain in bones and muscles; Tingling pain in bones and muscles; Tingling pain in bones and muscles; Lymph nodes in armpits and legs hurt; Lymph nodes in armpits and legs hurt; Headache approaching migraine; This is a spontaneous report from a contactable consumer (patient) reported that a 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729), via an unspecified route of administration, administered in arm left on 03Apr2021 16:15 (at the age of 50-years-old) as a single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. The vaccine was administered at the school or student health clinic. The patient medical history included occasional migraine headaches from allergies and hormones from an unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6204), administered in arm left on 13Mar2021 16:15 (at the age of 50-years-old) for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. On 04Apr2021, the patient experienced sever chills 1-4 am post vaccine. High of 102 degree fever 3:00 pm following day (04Apr2021) until falling asleep around 9. On Apr2021, the patient woke up drenched several times. Muscles felt like she's been shocked with high voltage. Tingling pain in bones and muscles. Lymph nodes in armpits and legs hurt. Headache approaching migraine. No treatments were received for the events. The outcome of the events was recovering.
50 2021-04-24 lymph node swelling Swollen lymph nodes in armpit on side of injection
50 2021-04-24 peripheral swelling, lymph node swelling Two days after I received my second covid vaccination shot, I woke up with a swollen arm, a swollen ... Read more
Two days after I received my second covid vaccination shot, I woke up with a swollen arm, a swollen hand, and hives on my back and on the back of my neck. As the day progressed I experienced a low grade fever, body aches, headache, and fatigue. I contacted urgent care and Telehealth. I was perscribed pain relief and an antihistamine. My fever broke last night however the swelling in my armpit and the body aches are still present.
50 2021-04-24 swelling Joints that were swollen became red, hot and more swollen including third toe on left foot, right an... Read more
Joints that were swollen became red, hot and more swollen including third toe on left foot, right ankle and foot, left hip, right wrist and right thumb.; hot and more swollen including third, toe on left foot, right ankle and foot, left hip, right wrist and right thumb; hot and more swollen including third, toe on left foot, right ankle and foot, left hip, right wrist and right thumb; Joints that were swollen became red, hot; This is a spontaneous report from a contactable other hcp. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 14:30 (Batch/Lot Number: ER8730) as SINGLE DOSE for covid-19 immunisation. Medical history included Small fiber peripheral neuropathy, Enteropathic Arthritis Associated With Inflammatory Bowel Disease , vulvodynia, frequent PVCs, allergy with pollen, mold, fungi, dander and dust. food sensitivities but no true allergies. Patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Mar2021, for covid-19 immunization and experienced fatigue and joint swelling. The patient's concomitant medications were not reported. The patient experienced joints that were swollen became red, hot and more swollen including third toe on left foot, right ankle and foot, left hip, right wrist and right thumb on 25Mar2021 20:00. Therapeutic measures were taken as a result of all events. Outcome of all events was not recovered. Case was reported as non-serious. No Follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : same patient different vaccine dose
50 2021-04-25 pancreatitis First one was 45 mins after injection. - Numbness of the left side of my face. The next day was tir... Read more
First one was 45 mins after injection. - Numbness of the left side of my face. The next day was tired and slept most of the day. This was the same as my first shot. Tuesday, I woke up with a stomach ache. Thursday because it did not get better, I went to the emergency room and was diagnosed with pancreatitis. Was given the option to be hospitalized or go home. I went home. Followed up with Dr's office Monday. I see GI Doctor this Wednesday. Still cannot eat, nauseous and stomach hurts.
50 2021-04-25 peripheral swelling Pfizer BioNTech COVID 19 Vaccine EUA Had a high fever of 102.7, extreme headache and body aches, nau... Read more
Pfizer BioNTech COVID 19 Vaccine EUA Had a high fever of 102.7, extreme headache and body aches, nausea, and extreme vomiting that led to dehydration. Extreme dizziness. Four days later on Saturday, my arm swelled badly and broke out into hives in a six inch radius around the injection site.
50 2021-04-26 lymph node swelling Lymphadenopathy and lymphatic cording limiting use of the arm and severe pain all the way to the wri... Read more
Lymphadenopathy and lymphatic cording limiting use of the arm and severe pain all the way to the wrist. Pain is constant, limiting sleep, and more severe with raising the arm above the head. Continuous pain three weeks after 1st shot.
50 2021-04-26 peripheral swelling, lymph node swelling Extreme chills, shivering, fever 102, itching at shot site, swollen arm, very tender and big swelli... Read more
Extreme chills, shivering, fever 102, itching at shot site, swollen arm, very tender and big swelling of lymph node in armpit.
50 2021-04-27 lymph node swelling Morning of the second day after vaccination: Red rash on chest between breasts, slightly itchy. Rash... Read more
Morning of the second day after vaccination: Red rash on chest between breasts, slightly itchy. Rash on two sides of the base of my neck Rash on the lateral side of my left breast. Large swelling in area of left underarm and breast. Not just a swollen gland, but puffy swollen tissue that when I lift my arm looks like there?s no armpit, it?s all swollen.
50 2021-04-27 peripheral swelling Significant muscle pain and swelling extending from left thigh over lower pelvic area.
50 2021-04-27 swelling face Shortly after receiving 2nd dose, client started to experience a constant and severe headache accomp... Read more
Shortly after receiving 2nd dose, client started to experience a constant and severe headache accompanied with a swollen face. Client has seen her PCP and was given a shot for tension headaches - did not relieve pain. Client went to ER 4/27/2021 and was treated with pain shots - little relief from pain. Client is still experiencing headaches and swelling. Client has an upcoming appointment with a neurologist in May.
50 2021-04-28 anaphylactic reaction Anaphylaxis. 36 hours after 2nd vaccination. Closing of of chest muscles, lungs, esophageal tract up... Read more
Anaphylaxis. 36 hours after 2nd vaccination. Closing of of chest muscles, lungs, esophageal tract up to back of throat. Resting heart rate of 133 BPM at triage in ER. Severe coughing which caused vomiting. Slight pink flushing of nose and cheekbones 30 minutes after shot, after leaving vaccination site, with no adverse reaction.
50 2021-04-28 swelling face Swollen red face itching skin is flaking. Sore throat, slight aches and pains. The swollen red f... Read more
Swollen red face itching skin is flaking. Sore throat, slight aches and pains. The swollen red face, and skin flaking was more severe on the second shot. The first shot I had just a sore throat , aches and pains.
50 2021-04-28 white blood cell count increased Extreme throat, mouth, soft pallate, jaw, and tooth pain (all teeth), headache, fever
50 2021-04-29 lymph node swelling Sore throat/enlarged right submandibular node 4/24 - resolved 1-2 days Macular/Papular/Vesicular ras... Read more
Sore throat/enlarged right submandibular node 4/24 - resolved 1-2 days Macular/Papular/Vesicular rash started 4/26 on torso - isolated to abdomen and back - possible widespread shingles Fever, chills started 4/28 and resolved 4/29
50 2021-04-30 anaphylactic reaction Anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient). A 50 -Yea... Read more
Anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient). A 50 -Year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER87306), via an unspecified route of administration, administered in left arm on 25Mar2021 at 21:27 (at the age of 50 years old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 the patient experienced Anaphylactic reaction. The patient visited emergency room on 25Mar2021 and and was released from the emergency room on 26Mar2021. The patient received treatment for the events. Caller stated from her understanding from her doctor she was not anaphylactic to anything in the shot but she had an anaphylactic reaction. Caller stated she wanted know since the vaccine is federally regulated and mandated and she has health insurance but her (Services name) and deductible is high and her being anaphylactic to the shot and receiving care and now receiving bills does Pfizer offer any help with that. Anaphylactic reaction: Caller stated this ended the next morning because it was overnight when she was released from the hospital. Caller clarified she was brought to the emergency room and was released from the emergency room. Treatment: Caller stated she was provided medication at the site of the (Name) and then put in an ambulance and was given medication then transported to the hospital. Caller stated the COVID vaccine she received was the first dose and last dose. Caller stated the physician office was not open and the hospital she wanted to go to was approximately 30 minutes away and she was transported to the nearest hospital to the facility location. The patient did not undergo any lab tests and procedures. The outcome of the events was recovered on 26Mar2021.
50 2021-04-30 lymph node swelling Headache - 29APR21 5:00pm - 30APR21 3:00pm Swollen lymph nodes (most notably in neck/throat area and... Read more
Headache - 29APR21 5:00pm - 30APR21 3:00pm Swollen lymph nodes (most notably in neck/throat area and under arms) 30APR21 2:00 AM - 01MAY21 9:00 AM Overall body aches/pains 30APR21 2:00AM - 01MAY21 09:00AM Fever/Chills - 30APR21 2:00AM - 01MAY21 9:00AM All resolved; no treatment taken
50 2021-04-30 peripheral swelling Chills, skin sensitive to the touch, sharp pains here and there, stiff neck and tired on Friday. La... Read more
Chills, skin sensitive to the touch, sharp pains here and there, stiff neck and tired on Friday. Late Friday night chills again low grade fever, sensitive to touch and swelling in one finger and sharp pains in legs and body. Weird feeling at times.
50 2021-04-30 swelling, peripheral swelling A Blood clot was found; Cellulitis; Migraine started within 24 hours; left calf pain/Leg increased i... Read more
A Blood clot was found; Cellulitis; Migraine started within 24 hours; left calf pain/Leg increased in swelling and burning pain; severe swelling and burning sensation; severe swelling and burning sensation; Leg increased in swelling and burning pain; Phlebitis; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199/EN5318), via an unspecified route of administration administered in left arm at doctor's office/urgent care facility on 12Mar2021 15:00 as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not COVID tested post vaccination. The patient had no other vaccines in four weeks. Medical history included high blood pressure and sleep apnea. Concomitant medications included amoxicillin, valsartan, amlodipine, and vitamin d [vitamin d nos]. The patient previously took doxycycline and experienced allergies. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. On 05Apr2021 at 03:00 PM, the patient experienced a blood clot was found, cellulitis, migraine started within 24 hours, left calf pain/leg increased in swelling and burning pain, severe swelling and burning sensation, leg increased in swelling and burning pain, and phlebitis. It was further reported that migraine started within 24 hours. 48 hour left calf pain that got increasingly worse leading to a severe swelling and burning sensation. The patient went to right time urgent care on Friday, 09Apr2021. The patient was diagnosed with cellulitis. It was also reported that pain increased swelling spread and went to emergency room (ER) on 10Apr2021 for ultrasound of leg. No clots and was advised if worsened to come back. The patient's leg increased in swelling and burning pain. The patient went to urgent care patient first on 11Apr2021 and then the doctor on Monday, 12Apr2021 where she was sent for a STAT ultrasound due to major pain and swelling. A blood clot was found. Phlebitis was diagnosis. The patient was sent to a vascular surgeon on 13Apr2021 and vein specialist on 15Apr2021. The patient was given Xarelto blood thinners and started taking them on 15Apr2021. All of this began 48 hours after taking the second vaccination (pending clarification) and has the patient worried. The events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from all events.
50 2021-05-02 lymph node swelling superclavicular lymphadenopathy on the left side
50 2021-05-02 swelling face, swelling Swelling and redness of face, neck and throat appeared about 30 minutes after vaccine. Patient took ... Read more
Swelling and redness of face, neck and throat appeared about 30 minutes after vaccine. Patient took hydroxyzine hydrocloride 25 mg within 45 minutes after vaccine. Redness and swelling receded about 30 minutes after taking hydroxyzine HCL, but symptoms came back after about 6 hours and a second does of the Hydroxyzine HCL was taken. Symptoms did not reoccur after second does of Hydroxyzine HCL.
50 2021-05-03 lymph node swelling, swollen extremities Pfizer-BioNTech COVID-19 Vaccine EUA: nine and eleven days after vaccination during clinic visit pat... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: nine and eleven days after vaccination during clinic visit patient reports left axillary swelling radiating down left arm. Subsequently developed numbness and tingling to left hand/fingers seven days after vaccination. Arthralgias, joint swelling, mylagias, and weakness also noted. After first visit patient prescribed methylprednisolone. Two days later patient returned to clinic with improvement in swelling but reports tremors and three new bumps on arm, palpitations, and weakness/numbness of 4th and 5th digits on left hand proximally. Patient referred to neurology and physical therapy with diagnosis of ulnar neuropathy.
50 2021-05-04 lymph node swelling, lymph node pain Approximately 24 hours after the second shot I noticed moderate neck pain on the left side around th... Read more
Approximately 24 hours after the second shot I noticed moderate neck pain on the left side around the collar bone. Upon self examination the area the lymph node in that area was significantly swollen, painful to the touch and squishy which is to say I did not hard. The skin in the area was red. I had several other symptoms that are being commonly reported. The symptoms listed below started to occur at approximately 4 hours after the second shot. These symptoms lasted for approximately 18 hours after the shot was administered. Headache, stomach ache, muscle cramps, fatigue, chills, overall body aches and dizziness. I contacted my doctor four days after regarding the lymph node concerns as the swelling was still a concern. I was seen the same day and advised to report back if the swelling did not go down. I am reporting this two days after my doctor's visit. The swelling is continuing to go down. The area is still somewhat painful when gently rubbed. The skin in the area is no longer red. I checked the box as not having recovered because the swelling has not completely gone away as of the time of this report.
50 2021-05-04 white blood cell count increased Shortness of breath, DOE, worsening daily from time of shot to now. PCP on 4/13, CXRAY 4/16, Pulmono... Read more
Shortness of breath, DOE, worsening daily from time of shot to now. PCP on 4/13, CXRAY 4/16, Pulmonology 4/26/21, ER 5/3/21 and admitted.
50 2021-05-05 anaphylactic reaction Rash at injection site with hives, anaphylaxis started. I took benadryl and topical cream and used i... Read more
Rash at injection site with hives, anaphylaxis started. I took benadryl and topical cream and used inhaler Also have extremely runny nose, congestion and fatigue
50 2021-05-05 c-reactive protein increased Fever within a couple of hours. Crushing muscle aches and pain. (rating 9/10) Disorientation. Headac... Read more
Fever within a couple of hours. Crushing muscle aches and pain. (rating 9/10) Disorientation. Headache. Nausea. Extremely severe fatigue. Difficulty breathing (wheezing, a corset 6x too tight around torso and elephant sized weights on shoulders). Worst from hours 26-68. Fatigue still lingers at a moderate level. Severe depression (without immediate previous prior indication) started after the 3 days of severe illness. Depression still at a moderate to severe level. Medical attention sought and anti-depressants prescribed. Ineffective. Labs post injection showed a nearly 3x increase in hsCRP from prior to injection as well as ANA titer pattern change.
50 2021-05-05 peripheral swelling Woke up on Saturday the day after the shot and fingers were swollen. Sunday started brain fog into t... Read more
Woke up on Saturday the day after the shot and fingers were swollen. Sunday started brain fog into the week and really bad on Wednesday.
50 2021-05-05 swelling, peripheral swelling, swelling face Patient was treated on 3/10/21 w/ 3 days of Bactrim for UTI. First COVID vaccine 3/18/21, that day d... Read more
Patient was treated on 3/10/21 w/ 3 days of Bactrim for UTI. First COVID vaccine 3/18/21, that day developed redness and swelling of face, low back, chest, feet. Rash is persistent to this date with no imprvovement. She had bloodwork to rule out, RA, Lyme, thyroid disease all within normal limits. Skin biopsy was done 4/1/21 which showed likely hypersensitivity reaction to drug or ssytemic allergic versus a connective tissue disease. Stains that were done argue against Lupus.
50 2021-05-06 swelling Fatigue Muscle or body aches Sore throat Congestion or running nose
50 2021-05-06 lymph node swelling Fever (around 101 F on 5/5/2021--resolved within 6 hours on 5/5/2021), Severe Headache (started 5/5/... Read more
Fever (around 101 F on 5/5/2021--resolved within 6 hours on 5/5/2021), Severe Headache (started 5/5/2021 about the same time as the fever. Headache has downgraded to minor headache by 5/7/2021) Swelling of lymph nodes in Left side arm pit (started 5/6/2021 and mostly resolved by 5/7/2021)
50 2021-05-06 peripheral swelling Arm swollen, body ache, headache, Chill and slight fever
50 2021-05-06 peripheral swelling Menstrual cycle was longer than usual (39 days vs 26-28 days), the duration of menstruation was doub... Read more
Menstrual cycle was longer than usual (39 days vs 26-28 days), the duration of menstruation was doubled and was heavy, experienced headaches and cramps for 4 days, experienced tightness in muscles especially in abdomen and legs for 3 days, both feet were noticably swollen for 2 days. Normally no cramps and never have headaches.
50 2021-05-06 swelling localized erythema/swelling. also reports mild headache, history of chest tightness but does not fe... Read more
localized erythema/swelling. also reports mild headache, history of chest tightness but does not feel this is related
50 2021-05-07 c-reactive protein increased, white blood cell count increased, systemic inflammatory response syndrome, high blood cell count 1st Pfizer Covid vaccination on April 1, 2021 Morning of April 2 she woke up with severe lower extre... Read more
1st Pfizer Covid vaccination on April 1, 2021 Morning of April 2 she woke up with severe lower extremity spasticity and the inability to mobilize. Presented to hospital April 3rd. Started high-dose intravenous Solu-Medrol on hospital day 3 and it was not until hospital day 4 that we begin to see improvement of her spasticity and ability to move her legs Felt to be acute myositis, most likely an immune mediated post vaccination event Received 1000 mg IV Solu-Medrol x5 days Course complicated by bilateral pulmonary embolisms in setting of severe spasticity and immobility Hospitalized 4/3/21-4/13/21 Discharged to rehab, on day of discharge requiring maximal assist to stand and for transfers
50 2021-05-07 peripheral swelling Fever 103; total and severe body ache; chills; vomiting; swelling of hands; dizziness; terrible and ... Read more
Fever 103; total and severe body ache; chills; vomiting; swelling of hands; dizziness; terrible and constant abdominal pain; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Apr2021 15:00 (at the age of 50-years-old) (Batch/Lot Number: ew0169) as SINGLE DOSE for covid-19 immunisation. Medical history included weight abnormal, Pituitary tumor extracted, known allergies_PCN. Concomitant medications included omeprazole. The patient received first dose of BNT162B2 for Covid-19 immunisation on 30Mar2021 at 50-years-old. (Product: Covid 19, Brand: Pfizer, Lot Number: ER8727, Lot unknown: False, Administration Date: 30Mar2021, Administration time: 01:00PM, Vaccine location: Left arm, Dose Number: 1). On 08Apr2021 16:45, the patient experienced Fever 103, total and severe body ache, chills, vomiting, swelling of hands, dizziness, terrible and constant, abdominal pain. I have O Negative Blood and high percentages of Neanderthal DNA (more than 97% of population). The events were assessed as serious (disability). The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included body temperature: normal on 08Apr2021 Fever 103. The outcome of the events was not recovered. The patient did not have COVID prior vaccination, and was not covid tested post vaccination.
50 2021-05-07 white blood cell count increased I was not having any congestion, allergies, or asthma during the week leading up to the COVID vaccin... Read more
I was not having any congestion, allergies, or asthma during the week leading up to the COVID vaccine. The day after the injection, I had flu-like symptoms but no congestion or asthma. The following morning, I woke up with severe body aches and a pulse-oximeter reading of 85% oxygen, and my regular reading is 95% or higher, even off the ventilator and on room air. I remained on my night ventilator and turned up my oxygen from my usual 2 liters to 5 liters. I used my airway clearance devices and had a breathing treatment, but my pulse-oximeter reading didn't improve at all. I was nauseated and took Odanestron. I had severe body aches and took Acetaminophen. It didn't help. I took my temperature, and it was 103.7 an hour after taking the Acetaminophen. I went to the emergency room and was admitted to the ICU with pneumonia. I have had pneumonia several times in my life, but this was an extremely sudden onset
50 2021-05-09 anaphylactic reaction anaphylactic response, lasted 5 to 10 minutes only: very sudden/rapid onset of full-body vasodilatio... Read more
anaphylactic response, lasted 5 to 10 minutes only: very sudden/rapid onset of full-body vasodilation, heart palpitations, chest tightening/difficulty breathing
50 2021-05-09 lymph node swelling Lymph node swelling under right arm and on right side of neck. Neck lymph node swelling caused verti... Read more
Lymph node swelling under right arm and on right side of neck. Neck lymph node swelling caused vertigo for a short time the next morning. Neck lymph node swollen for 3 days. Armpit is still swollen. Aches, joint pain, fatigue, fever 101 have resolved. Nausea continues.
50 2021-05-10 lymph node swelling, swelling, peripheral swelling swollen lymph nodes; her arm started swelling and it progressed to her neck, chest and head, the swe... Read more
swollen lymph nodes; her arm started swelling and it progressed to her neck, chest and head, the swelling persist; her arm started swelling and it progressed to her neck, chest and head, the swelling persist; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 as single dose for COVID-19 immunization. Medical history included HAE hereditary edema. Concomitant medication included steroids. The patient received the first dose of the PFIZER-BIONTECH on 23Mar2021 within 8 minutes her arm started swelling and it progressed to her neck, chest and head, the swelling persist. On 24Mar2021, she went to ER they treated her first with Benadryl and anti-inflammatory drugs and then with steroids, she's been taking steroids for a month; she was diagnosed with HAE hereditary edema. She also experienced swollen lymph nodes on unspecified date. Patient stated she hadn't had a facial surgery and the swelling persist and it's been a month, she hasn't received the second dose of the vaccine. Patient would like to know when this was expected to go away and how protected she was from the first dose of the vaccine because she's also taking steroids. The outcome of the events was unknown. This report was assessed as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
50 2021-05-10 lymph node swelling Patient reported left ear pain, swelling of lymph nodes anterior cervical area one week post second ... Read more
Patient reported left ear pain, swelling of lymph nodes anterior cervical area one week post second dose. Then developed painful rash on face- diagnosed with shingles of face and eyelid. Patient is being referred to ophthalmology for evaluation and treatment.
50 2021-05-11 lymph node pain, lymph node swelling Pfizer-BioNTech COVID-19 Vaccine - Ran 103.8 fever first night, 100.0 fever, body aches, nausea seco... Read more
Pfizer-BioNTech COVID-19 Vaccine - Ran 103.8 fever first night, 100.0 fever, body aches, nausea second day, third day and beyond Covid arm, fever in injection site area and lymph node swelling/pain for several days, shortly after that Shingles appeared under my neck near the site of the swollen lymph nodes pain area. (Dr said mild case, thankfully, and was already inactive when I saw her on 4/28.)
50 2021-05-11 lymphatic obstruction No symptoms or reaction except later lymphedema
50 2021-05-12 anaphylactic reaction Anaphylactic reaction. treatment with EpiPen. patient treated with own EpiPen. EMT called and was re... Read more
Anaphylactic reaction. treatment with EpiPen. patient treated with own EpiPen. EMT called and was retreated with EpiPen. Also given Benadryl by RPh on duty. given IM Benadryl by EMT. Throat swelled up and pt has trouble breathing
50 2021-05-14 lymph node swelling Swollen lymphnodes. Went away by 5/15; however I did not hear of this being g a side effect and tho... Read more
Swollen lymphnodes. Went away by 5/15; however I did not hear of this being g a side effect and thought I should report it.
50 2021-05-14 swelling face Non-severe allergic reaction, face swelling around mouth, itchy face and neck. Took Benadryl to rel... Read more
Non-severe allergic reaction, face swelling around mouth, itchy face and neck. Took Benadryl to relieve symptoms.
50 2021-05-16 lymph node swelling Cough started 10 minutes post shot. Felt like congestion in lungs. Persisted the remainder of the ... Read more
Cough started 10 minutes post shot. Felt like congestion in lungs. Persisted the remainder of the evening/night. Gone by next day. Fatigue day after shot. Swollen, sore lymph node in armpit of arm that received shot. Symptoms still ongoing.
50 2021-05-16 lymph node swelling Immediately after inject of the first Pfizer vaccine, she could taste the vaccine in her mouth. The... Read more
Immediately after inject of the first Pfizer vaccine, she could taste the vaccine in her mouth. Then developed her mouth started "watering profusely". She had to swallow constantly. Then swallowing became difficult, she had chest tightness, and numbness in hands/arms. S he was moved to the rescue area with "fire rescue". Her BP 160/105. EMS arrived, transfer recommended. You consulted with your daughter who is a nurse, and opted to return home. She was at the fairgrounds for 2 house. She did not receive medications. Was provided crackers and water. After arriving home, her initial symptoms resolved, but she felt nauseated and "terrible". Over the next 3 days she had swollen lymph nodes on the side of the injection and felt "like she had been hit by a truck". After 3 days, those symptoms resolved and she felt well.
50 2021-05-18 swelling face Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, to... Read more
Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; This is a spontaneous report received from a contactable female consumer (patient). A 50-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN6207, Expiration date was not reported), via an unspecified route of administration on 27Mar2021 09:00 first dose single for covid-19 immunisation. Medical history included fatty liver, diverticulitis, migraine and cigarette smoke. The patient concomitant medications were not reported. The patient previously took sulfonamide (Sulfa / FQ drugs) allergy to sulphonaminde and histamine allergy to histamine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received within 2 weeks of vaccination of antioxidant Green Tea and Liver Cleanse Tea and Vitamin C. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient experienced Tingling and Swelling of lower face, lips, tongue, throat on 28Mar2021 02:30 AM. Patient visited the emergency room. As per the reporter seriousness criteria for the events swelling of lower face, lips, tongue, throat was medically significant. Patient received treatment of Benadryl-self-administered prior to ER. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021430745 similar report from same reporter
50 2021-05-19 axillary mass Very large, painful lump (not a lymph node) under the injection arm, in axillary area that almost re... Read more
Very large, painful lump (not a lymph node) under the injection arm, in axillary area that almost reached my breast. Not warm to touch, but painful. Not an abscess or cyst.
50 2021-05-20 lymph node swelling, lymph node pain Starting at 10pm April 24, Severe headache, migraine level, both eyes watering, ears ringing, could ... Read more
Starting at 10pm April 24, Severe headache, migraine level, both eyes watering, ears ringing, could not look at light. Fever just under 101, rash on scalp starting around 12 midnight. Aches, exhaustion, slight stomach upset. Took Tylenol. Headache did not go away, felt likeTylenol did nothing. Fever and severe headache lasted 4 days. Aches lasted 5 days. On DAY 2 after vaccine, 2 hard, golf-ball sized lumps under left arm appeared, and some others slightly smaller (lymph nodes). Lumps were too painful to sleep on that side or do any normal physical activity. Fever and most aches resolved after Day 4, but Lymph nodes stayed golf ball size and painful for 3 weeks. At time of this report, it has been 4 weeks, postponed 2nd shot one extra week hoping nodes would improve, they have reduced in size but are still very swollen and sore. Also ache at sternum (??) has not resolved at all.
50 2021-05-21 lymph node swelling Very bad rash which was red and itchy under her breast area; Swollen lymph node under left arm large... Read more
Very bad rash which was red and itchy under her breast area; Swollen lymph node under left arm larger than right; She thought she had breast cancer; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 11Apr2021 14:30 as 1st dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that the patient received her 1st dose of the COVID-19 vaccine on 11Apr2021. About 10 days after, on 21Apr2021, she developed a very bad rash which was red and itchy under her breast area, along with a swollen lymph node. She has gone thru several doctors to which she was currently consulting a dermatologist. She stated that the dermatologist gave her a steroid shot and took a biopsy. She was treated with prednisone which did not help, antibiotics which also did not help, and steroid shots which helped for 2 days, after which the rash went back. She is taking Benadryl and Zyrtec for the rash, to which she mentioned that Benadryl is the only thing that helped it but caused her to get sleepy. Zyrtec took hours before it exhibited the affect. She is holding off on antihistamines because she needs to stay awake during the day. She mentioned that she is feeling a little better at the time of report, the rash has lightened but was still there and still itchy, but it seems to have toned down and it is not inflamed and red. She thought she had breast cancer, the lymph node under her left arm and along the breast has a strong itchy rash and the lymph node was swollen. The patient was aware of 42-day window that is allowable. She had already rescheduled her 2nd dose to be done on 16May2021, but her doctor recommended her to delay it again, the rash needs to calm down before the booster, second shot. She is concerned of what to do if she passes that 42-day window. She doesn't know if she feels safe to take the second vaccine. The outcome of the event "She thought she had breast cancer" was unknown, and for other events was unknown.
50 2021-05-24 peripheral swelling Itching of hands and swelling of hands on day 2. of 1st vaccine. Headache, tinnitus, body aches, ra... Read more
Itching of hands and swelling of hands on day 2. of 1st vaccine. Headache, tinnitus, body aches, rash, and overall tiredness. Itching on feet ,hands, arms, and hives on back, ribs, core body and neck with second vaccine
50 2021-05-25 anaphylactic reaction Minor allergic reaction; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb t... Read more
Minor allergic reaction; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; sore arm; This is a spontaneous report from a contactable consumer (the patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0151), dose 1, single dose via an unspecified route of administration, administered in arm left on 14Apr2021 for covid-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Past drug event included allergy to ampicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced minor allergic reaction, swollen, tingling, and numb tougue and lips and sore arm on 14Apr2021. Therapeutic measures taken as a result of minor allergic reaction, swollen, tingling, and numb tougue and lips. and sore arm included diphenhydramine (BENADRYL). The outcome of minor allergic reaction, swollen, tingling, and numb tongue and lips, sore arm was recovered with sequelae. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the known safety profile, a possible contributory role of BNT162B2 to the development of minor allergic reaction cannot be excluded.
50 2021-05-25 lymph node swelling Extremely sore and swollen glands; Itchy throat; This is a spontaneous report received from a contac... Read more
Extremely sore and swollen glands; Itchy throat; This is a spontaneous report received from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 12Mar2021 at 04:30 PM (at the age of 50-years-old) as a single dose for COVID-19 immunisation. No relevant medical history given. The patient reported of no known allergies. Concomitant medications include Magnesium (MANUFACTURER UNKNOWN), Levoxyl (MANUFACTURER UNKNOWN), Advil (MANUFACTURER UNKNOWN), Tylenol (MANUFACTURER UNKNOWN), Benedryl (MANUFACTURER UNKNOWN) for an unknown indication and unknown date. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. On 12Mar2021, the patient experienced itchy throat approximately 30-35 minutes after receiving the vaccination. On 14Mar2021, the patient experienced extremely sore and swollen glands on the back of neck. No treatment was received for the itchy throat and extremely sore and swollen glands. The clinical outcome of the event itchy throat & extremely sore and swollen glands was not recovered. Information about lot/batch number cannot be obtained. No further information is expected.
50 2021-05-27 swelling face, oral herpes, lymph node swelling Rash all over body similar to shingles. Swollen lymph nodes. Was in ER two different times due to th... Read more
Rash all over body similar to shingles. Swollen lymph nodes. Was in ER two different times due to the rash, and face swelling. Lip was swollen on right side similar to a very large cold sore that has lasted for 8 weeks. Very painful. Doctors also have tested me for an autoimmune disease, that has come back positive. ANA Titer 1:1280. Possibly this has brought to surface an underlying autoimmune disease due to the fact that I had Covid-19 so bad. Was hospitalized with it, and had neurological issues along with GI problems. No respiratory problems.
50 2021-05-28 swelling face, peripheral swelling Swelling of face and feet; swelling of face and feet; headache; Left arm where shot was administered... Read more
Swelling of face and feet; swelling of face and feet; headache; Left arm where shot was administered was hot to the touch.; This is a spontaneous report from a contactable other Health Care Professional (patient). A 50 years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: En6205 and expiry date was not provided) via unspecified route of administration in the left arm on 05Mar2021 at 02:15 PM as a single dose for COVID-19 immunisation (age at vaccination was 50 years). The patient's medical history was not reported. Patient had no known allergies. Patient's concomitant medication included melatonin, multivitamin and diphenhydramine HCL at 50 mg; all for unknown indication on unspecified dates (with in two weeks of vaccination). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Mar2021 at 02:30 PM (same day of vaccination) the patient experienced headache and Left arm where shot was administered was hot to the touch. Patient had swelling of face and feet on 06Mar2021. Headache happened right after shot, swelling was the next day (06Mar2021). Patient took Benadryl 50 mg twice as a treatment. The outcome the events headache and Left arm where shot was administered was hot to the touch was recovered on an unknown date in Mar2021; and the events swelling of face and feet were recovered on 06Mar2021. No follow-up attempts are possible. No further information is expected.
50 2021-05-28 swelling face Her throat was swollen; Bruise under chin/Her throat had bruising; She had an allergic reaction; Str... Read more
Her throat was swollen; Bruise under chin/Her throat had bruising; She had an allergic reaction; Strep throat.; She couldn't swallow water; she would jerk if she swallowed water and it was a hurting feeling going down. Her throat was so swollen she could hardly eat; Lip, Jaw and face swollen; Lip, Jaw and face swollen; Throat was going to close; This is a spontaneous report from a contactable consumer reporting for herself. A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0150) 17Apr2021 at single dose via an unspecified route of administration on arm left for COVID-19 immunization. Relevant medical history included ongoing hypertension, ongoing from 2016 Blood clot on her right kidney, ongoing from 2016 high cholesterol. The patient received first dose of BNT162B2 (Lot Number: ER8730) on 21Mar2021 around 11:00am on left arm and experienced allergic reaction, Face swollen, she was like the Nutty Professor doing the clump (as reported). Concomitant medications included warfarin for Blood clot on her right kidney and an unspecified product for cholesterol control. Patient reported her lip, jaw, and whole face were swollen around 19Apr2021 or 20Apr2021 until 22Apr2021. She says she went to Urgent Care, they gave her Benadryl, and admitted her to the hospital because they thought her throat was going to close starting from 20Apr2021 or 21Apr2021 until 21Apr2021. Starting from 09May2021 in the afternoon until 10May2021 in the night patient reported she couldn't swallow water; she would jerk if she swallowed water and it was a hurting feeling going down, she thought it was strep throat. Patient also reported under her chin was like a frog out on a log when they inhale and exhale (as such). Starting from Sunday night on 10May2021 her throat was so big and she presented a bruise under chin like someone put their hands up in there and choked her (as reported). Patient informed that her chin was swollen also. Patient went to the hospital where they tested her for strep and released her out of the hospital around 4:00pm. Patient reported she was admitted for one day on 10May2021 and they gave her Benadryl again, another medicine, throughout the day they even did a CAT scan. She says through the day she could start swallowing again. Patient got up Monday (11May2021) and went to the emergency room. She reported that under her chin was swollen where is throat. Her throat had bruising under it and her throat was swollen and she had to go back to the hospital. They gave her Benadryl for her swelling. During call about the Pfizer COVID-19 vaccine, patient reported she had both doses and had an allergic reaction to vaccine, she was assuming it was for BNT162B2. At the time of the reporting outcome for 'Bruise under chin' and 'She had an allergic reaction' was unknown. The patient recovered from Lip, Jaw and face swollen on 2Apr2021, from 'Strep throat' and from 'She couldn't swallow water; she would jerk if she swallowed water and it was a hurting feeling going down. The patient recovered from 'Her throat was so swollen she could hardly eat' and 'Strep throat' on 10May2021, from 'Throat was going to close' on 21Apr2021, while had not yet recovered from other reported events.
50 2021-05-28 swelling face an allergic reaction to the Pfizer; face swelling/She says she was like a actor doing the clump. She... Read more
an allergic reaction to the Pfizer; face swelling/She says she was like a actor doing the clump. She says her lip and jaw looked just like that; She says she was like a actor doing the clump. She says her lip and jaw looked just like that.; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 21Mar2021 11:00 (at the age of 50-year-old) as 1st dose, single for covid-19 immunisation. Medical history included ongoing high blood pressure, blood clot on her right kidney from 2016, high cholesterol from 2016. Concomitant medications included warfarin; cholesterol. The patient was calling about the Pfizer COVID-19 vaccine. She says she had both of them. She says she had an allergic reaction to the Pfizer; she is assuming it was the Pfizer. She says the 15th through the 19th she was like a actor doing the clump. She says her lip and jaw looked just like that. She says it was at a the pharmacy. She says she went to Urgent Care, they gave her Benadryl, and admitted her to the hospital because they thought her throat was going to close(it started 20Apr2021 or 21Apr2021 and ended on 21Apr2021). The patient stated she was started on a high blood pressure medication after the first time of being in the hospital with face swelling. Prior Vaccinations (within 4 weeks) there is no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. There is no AE following prior vaccinations. The patient says she has no allergies and was not sick at the time of either vaccination. There is no Family Medical History Relevant to AE. The outcome of the events was unknown.
50 2021-05-31 white blood cell count increased, sepsis Patient is a 50 year old female with history significant for autism, developmental disability, hyper... Read more
Patient is a 50 year old female with history significant for autism, developmental disability, hypertension, seizures, frequent falls, Tourette syndrome, s/p CVA. She presented 3/31/2021, through the Emergency Department from home with following an unwitnessed fall. She was found by her mother this evening on the floor at the bottom of a flight of stairs. She was last seen by her mother sometime in the morning. Patient not capable of providing history as verbalizations are limited at baseline to occasional single word expressions of needs. Patient was noted in the ED to have multiple bruises to her head, arms and legs in various stages of healing. Patient lives with her mother who is also her legal guardian. Mother was poor historian in the ED and was unable to help determine how long patient was on the floor. Patient's mother verbalized to ED provider that she is not able to supervise the patient at all times due to her own medical needs. ED provider noted that upon leaving the ED the patient's mother stated to staff that they should put the patient out of her misery. County Crisis Center was contacted by ED staff and a referral was made to Adult Protective Services. Patient does not answer review of systems questions when asked. Admit date: 3/30/2021 Discharge date: 4/5/2021 Primary diagnoses: Principal Problem: Severe sepsis, unknown origin, without end organ failure o Resolving, no fever o Vancomycin stopped. o Wbc improving, fever resolved o Blood cultures still negative o After 4days of IV antibiotics she was transitioned to oral augmentin whenDcing flagyl. o PCP to follow fever curve, white count... CT chest abdomen and pelvis negative at admission Blood cultures have remained negative Active Problems: Benign essential HTN Developmental disability Residual autistic disorder Fall o Most recent fall 03/30/2021, unwitnessed, possibly down unknown number of stairs o Followed by Neurology, for frequent falls, EEG on 01/18/2021 abnormal with focal epileptic seizures suspected, she has been started on Lamictal taper o Continue Lamictal as prior to admission Rhabdomyolysis o Due to Unwitnessed fall and immobile on floor for unknown number of hours on 03/30/2021 o CPK trending down. Kidney function has remained normal with ongoing IV infusion Hyponatremia Elevated troponin I level Cardiology, Dr. consulted from the ED, elevated troponin suspected to be secondary to rhabdomyolysis o Troponin 1.58 upon arrival, peaked at 1.88 and declining is subsequently o EKG demonstrates sinus tachycardia with 1st degree AV block and RBBB, rate 101, QTc 487 Echo was normal at 60% ejection fraction Closed anterior dislocation of right glenohumeral joint was reduced in the emergency department which will explain the large bruise over her right shoulder right shoulder active and passive range of motion intact Hypomagnesemia
50 2021-06-02 lymph node swelling Developed paresthesia (tingling, pins and needles) in legs and arms, intermittent, moves around; mor... Read more
Developed paresthesia (tingling, pins and needles) in legs and arms, intermittent, moves around; more predominant in feet and hands; tender left supraclavicular lymphadenopathy (same side as vaccine administration); This is a spontaneous report from a contactable physician (patient). A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EN6203), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 11:30 (at the age of 50 years old) as 2nd dose, single for COVID-19 immunization. Medical history included paraesthesia (10 years ago) lasting approximately 8 weeks, diagnostic evaluation was negative, self-resolved (no history of vaccination then), hypercholesterolaemia from an unknown date and unknown if ongoing. No known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included atorvastatin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb2021 12:15 as 1st dose, single for COVID-19 immunization. 06Mar2021 13:00, the patient developed paraesthesia (tingling, pins, and needles) in legs and arms, intermittent, moves around and more predominant in feet and hands. The patient also had tender left supraclavicular lymphadenopathy same side as vaccine administration. The patient did not receive any treatment for the events. The clinical outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
50 2021-06-02 peripheral swelling heart rate elevated; muscle pain; blood cell counts abnormal; equilibrium off; Blurred vision; Diarr... Read more
heart rate elevated; muscle pain; blood cell counts abnormal; equilibrium off; Blurred vision; Diarrhea; felt sick all day; sinuses feel off; pressure from headaches; Feeling hot and cold; Chill; fever 101.7 up to 103/ fever 103°F; foggy; Nauseous; tired; Light-headed; pain in arm; couldn't sleep; pain in arm; couldn't sleep; left arm sore and inflammed; swelling; headaches; This is a spontaneous report from contactable consumer (patient) or other non HCP. A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch number/Lot number: EW0162, Expiration date: unknown), via unspecified route of administration in arm left on 09Apr2021, at 1ST DOSE, SINGLE for COVID-19 immunization. Patient medical history included ongoing prediabetic , Chronic sinusitis on unspecified date in 2014 and patient had undergone sinus surgery on unspecified date in 2014, COVID-19, acid reflux, patient had family history of father had a heart attack and mother had a heart attack and they are both diabetic. Concomitant medication included pantoprazole (PANTOPRAZOLE) on unspecified date at 2021 to ongoing for acid reflex which was diagnosed years ago, but has been actively taking for 3 months until now, multivitamin on unspecified date. Patient did not received any other vaccines Prior to that Vaccinations within 4 weeks. Patient had no know illness at the time of vaccination. 09Apr2021 patient experienced headaches, Light-headed, pain in arm; couldn't sleep, left arm sore and inflammed; swelling, on 10Apr2021 patient experienced chills, fever 101.7 up to 103/ fever 103°F, foggy, Nauseous, tired, Diarrhea, felt sick all day, sinuses feel off; pressure from headaches, Feeling hot and cold. on 12Apr2021 patient experienced equilibrium off, Blurred vision. on an unspecified date patient experienced heart rate elevated, muscle pain, blood cell counts abnormal. Patient reported that she had her Pfizer BioNTech vaccine on Friday 09Apr2021 and has had some serious side effects. patient wants to understand why she had such bad side effects compared to other people. Husband and other people she knows didn't have any side effects and she did. She states her next shot on 30Apr2021 and when she got the Pfizer COVID-19 vaccine, she felt fine as stayed the wait time at the facility but got lightheaded when she got to her car. She reported that on 09Apr2021 she had the lightheadedness comes and goes and she also experienced a headache and her arm soreness inflammed; swelling on 09Apr2021 in Friday. She reported that her arm pain was so bad that she couldn't not sleep. She could not lay on it. she states it is a little better now, it still hurts, but she is able to roll off of it and get some sleep. Patient experienced chills and a fever from 101.7 up to 103 degrees and Feeling hot and cold on Saturday 10Apr2021. she stated that she was taking Ibuprofen for pain and fever, and was told she shouldn't take Ibuprofen, she should take Tylenol to break the fever and she took some Tylenol and her fever broke after taking Tylenol. Patient stated that on 10Apr2021 she had also felt foggy, nauseous and tired. She reported that she had COVID in Jun2020 and felt like COVID all over again. she had the same symptoms; really tired, could sleep for days. patient thinks she had a bit of an allergic reaction on her arm. It has improved, but now she has a red swollen splotch on her arm, and it is not even where they put the needle it is down a little bit lower. Patient reported that her heart rate was elevated as well. Patient reported that 12Apr2021 she felt like equilibrium is off, and had blurred vision, feels fine right now, but all she has done was slept since she got home from work yesterday and hasn't exerted herself today yet and right now she is not tired, she slept for 12 hours. Patient reported that she felt sick all-day and had diarrhea on 10 Apr2021 in Saturday, nausea started on Saturday, all she could eat was chicken noodle soup and she experienced it yesterday. she states yesterday she took some Tylenol, and got a chicken sandwich, since she had taken some medication, and then wanted to throw it up when she got home and she is not foggy now, but it comes and goes, the symptoms are intermittent, she doesn't know if she will be ok. she can still feel on 10 Apr2021 her had sinuses feel off and she had chronic sinusitis and whenever she gets sick her sinuses get attacked. she states she didn't think she would get side effects because she already had COVID, but apparently it is the opposite. Patient reported that she was being told so many different things and now she was scared to get the second shot and is freaking out. she reported that she had to cancel all the appointments at work yesterday day because of the events and she thought she would have the weekend to recover from any side effects but couldn't do her job yesterday. Patient was not their in-Emergency Room nor visited physician office. It was reported that blood cell counts abnormal, so her doctor has her going to see a hematology doctor on Thursday. It could be nothing but sending there to check. The patient underwent lab test and procedure which include blood cell counts abnormal on 10 Apr2021 Outcome of events headache, chills, fever, foggy, nausea, tired, equilibrium off, Blurred vision, felt sick all day, sinuses feel off; pressure from headaches, heart rate elevated, muscle pain were unknown, light-headed, Diarrhea, Feeling hot and cold were not resolved, pain in arm; couldn't sleep, left arm sore and inflammed; swelling, were resolving, Follow up (13Apr2021): This is a follow-up spontaneous report from contactable consumer. A 50-year-old female patient reported new information received which included event detail, relevant medical history, concomitant medication. No Follow-up attempts are needed. No further information is expected
50 2021-06-03 lymph node swelling The patient reported facial numbing for about 10 minutes, as well as head/clavical pain that lasted ... Read more
The patient reported facial numbing for about 10 minutes, as well as head/clavical pain that lasted hours, and a swollen lymph node and that lasted a day.
50 2021-06-03 lymph node swelling Sore joints; temp 100; chills; swollen lymph nodes in right armpit; mild headache; This is a spontan... Read more
Sore joints; temp 100; chills; swollen lymph nodes in right armpit; mild headache; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Right arm on 04Mar2021 14:30 (at the age of 50-years-old) as a SINGLE DOSE for COVID-19 immunisation. The patient's medical history was not reported and patient had no known allergies. Concomitant medication included atorvastatin, taken for an unspecified indication on an unspecified date received within two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EC-3249), via an unspecified route of administration, administered in Left arm on 11Feb2021 at 14:30 (at the age of 50-years-old) as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 05Mar2021 at 09:00, the patient experienced Sore joints, temp 100, chills, swollen lymph nodes in right armpit, mild headache. The patient underwent lab tests and procedures which included body temperature: 100 degrees on 05Mar2021. No treatment was received for adverse events. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
50 2021-06-03 swelling face my face was swollen; right side of my mouth and jaw hurting; right side of my mouth and jaw hurting;... Read more
my face was swollen; right side of my mouth and jaw hurting; right side of my mouth and jaw hurting; This is a spontaneous report from a contactable consumer (patient). A 50-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0186), dose 2 via an unspecified route of administration, administered in left arm on 16May2021 at 08:45 as 2nd dose, single for COVID-19 immunization (at the age of 50-years). Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0175), dose 1 via an unspecified route of administration, administered in left arm on 25Apr2021 as 1st dose, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Neither the patient diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received no other medications within 2 weeks of vaccination. On 18May2021, the patient woke up with the right side of my mouth and jaw hurting and her face was swollen. The first day, she tried to rinse with salt water and applied hot compresses to her face it didn't do anything. So she decided to do a tele doc video call the after the second day it wasn't getting better. The doctor prescribed antibiotics and told to her it was her tooth, however, she knew that it wasn't her tooth. The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021582710 different patient, same drug and event
50 2021-06-03 swelling patient reported swelling, knot in neck, right sided facial numbness. Injection site redness/sorenes... Read more
patient reported swelling, knot in neck, right sided facial numbness. Injection site redness/soreness. Also reported severe reactions to first dose Pfizer COVID 19 Vaccine (severe headache, muscle pain, injection site redness)
50 2021-06-04 neck mass two lumps that have appeared in my neck/on the left anterior and is the size of a large blueberry or... Read more
two lumps that have appeared in my neck/on the left anterior and is the size of a large blueberry or small grape/on the right anterior and is the size of a pea; This is a spontaneous report from a contactable consumer reporting for herself A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247) on 25Feb2021 at 11:15 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. The patient had not medical history. Concomitant medications were not reported. On 06Mar2021 at 12:30 pm the patient noticed two lumps that have appeared in my neck. One is on the left anterior and is the size of a large blueberry or small grape. The other is on the right anterior and is the size of a pea. Patient sawher primary care physician and she has ordered a CT scan to be performed and told patient that this could be potentially COVID vaccine- related. The patient received unspecified treatment. At the time of the reporting the patient had not yet recovered from the event. No follow-up attempts are possible. No further information is expected.
50 2021-06-07 lymph node swelling Swollen lymph node - left arm pit; naproxen, hot compress, massaging, stretching
50 2021-06-07 lymph node swelling This is a spontaneous report from a contactable consumer (reporting herself). This 50-year-old femal... Read more
This is a spontaneous report from a contactable consumer (reporting herself). This 50-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8729), via an unspecified route of administration in left arm on 14Apr2021 at 14:00 as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history included migraines (she takes migraine medication as needed). The patient's concomitant medications were not reported. None of the additional vaccines administered on same date of the Pfizer suspect. The patient received no other vaccination with 4 weeks of COVID vaccination. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7537, ER7534 or ER753U (lot number was handwritten on her vaccine record card, and she cannot read the last character), via an unspecified route of administration in left arm on 24 Mar 2021 at 14:00 as a single dose for COVID-19 immunization and experienced her arm was sore, Her period stopped after she got the covid vaccine and It has been almost 80 days, and she is still having extreme pain, in every part of her joints. On an unspecified date in Apr2021, the patient was experiencing joint pain throughout her body, was worse right after the vaccine but has gotten better but still experiencing pain, was wondering if this was a side effect of the vaccine. States she has already spoken with the safety department. On 15Apr2021, the patient's top left ear was in pain: Her ear was hurting on the same side she received the covid vaccine, her left side. Clarifies that her ear only hurt at the top, her cartilage part was what hurt. It was really odd, and very weird. It lasted for 4 or 5 days. On 15Apr2021, the patient's ear felt like it was burning and hurt painful. On an unspecified date in Apr2021, the patient was noticed a lymph node on the side of her neck on the same side she received the covid vaccine. On an unspecified date in Apr2021, every single point of her body hurt, every knuckle, finger and toe and it lasted about two weeks where it was very painful, but the patient still had it now. It began 2 or 3 days after she received the second dose of the covid vaccine. Now it has subsisted into feeling like a dull joint pain. Every point of her joints was weird, even padding of her feet hurt. Before her pain was a sharp joint pain. On an unknown date in 2021, the patient's having normal menstrual cycle till then but since receiving the vaccine she has not had one. She had spoked with her OB/GYN (obstetrics and gynaecology) and was advised to report to Pfizer, to which caller states she had already spoked with the safety department. The patient did not undergo any laboratory test. Event having normal menstrual cycle till then but since receiving the vaccine she has not had one resulted in Physician Office Visit. The outcome of the events Joint pain throughout her body, a lymph node on the side of her neck and every single point of her body hurt, every knuckle, finger and toe was resolving, top left ear was in pain and her ear felt like it was burning was resolved in Apr2021 and having normal menstrual cycle till then but since receiving the vaccine she has not had one was unknown. Followup attempts are possible, additional information has been requested.
50 2021-06-08 c-reactive protein increased Developed common side effects fatigue, aches and headache day 2. Day 6 developed severe temporal hea... Read more
Developed common side effects fatigue, aches and headache day 2. Day 6 developed severe temporal headache with palpable temporal scalp tenderness and neck ache with severe sleep disturbance lasting 3 days. After injection 2 developed similar but more symptoms day 5. Subsequent development of occipital neuralgia on left increasing frequency and duration with associated severe insomnia and chronic muscle spasms of neck, shoulders and chest. Also developed intermittent muscle cramps in legs, biceps and triceps as well as short lived muscle fasciculation. Treated with tizanidine, Medrol dose pack, Celebrex and massage with no relief. Occipital nerve block on 5/28 relieved occipital neuralgia but developed severe spasm of neck, shoulders, upper back and chest being treated with PT with reported mild improvement.
50 2021-06-08 oral herpes Wednesday, May 19, 2021 1st COVID-19 vaccination shot Summary: Wednesday, May 19, 2021 received my ... Read more
Wednesday, May 19, 2021 1st COVID-19 vaccination shot Summary: Wednesday, May 19, 2021 received my 1st COVID-19 vaccination shot. My body tried to reject it. I threw up 5 times. Ensued many unwanted side effects. I don?t think it would be good to get the 2nd vaccine dose. Given I am not fully vaccinated, I need an alternative solution to prevent being infected with the virus. Help!!!! Please Help!!! Bad Side Effects: Stuffy Nose Congested Nose Headaches Vomiting Nauseous Upset Stomach Unsettled Stomach Unusual Perspiration Pain in Left Arm Abnormal Period Menstrual Blood Clots Shoulder Pain/Tension Upper Back Pain/Tension Chest Pain/Tension Shooting Pain in Chest Heart Palpitations? Numbness Runny Nose Sneezing Profusely Allergies? Hoarse Voice Winded Dry Mouth Existing Worsened: Cold Sores Stomach Noises Snoring? Foot Numbness Ear Ringing Eye Floaters Joints Popping Sound Other Observations: Stomach Bloated Increased Flatulence Pseudo Conclusion: Given my body?s adverse reaction I don?t think it is wise to get the 2nd shot. It is obvious my body does not like it. I am disappointed because I really did not plan to get vaccinated; however, I felt I had no other option when the government made the announcement. When the government announced No masks for those vaccinated, I know there would be some NOT vaccinated & NOT wearing a mask thus putting me at risk. I am okay with wearing a mask for another year or even for the next 5 years. The doctors have said me wearing a mask is protecting others not necessarily myself. I concluded even if I continue to wear a mask there would be others (NO mask & NOT vaccinated) not following the rules potentially exposing me to the virus. Hence the only way to protect myself is to get vaccinated. The vaccine appears to have affected so many areas of my body. I regret getting the 1st shot, I want to remove every trace of it from my anatomy. Please let me know if it is possible to rid the vaccine along with all the bad side effects from my body. I do not want to subject my body to anymore of this vaccine; however, I still need a reliable solution to avoid being infected with the virus. I don?t know what to do. Details: Wednesday, May 19, 2021, I received my 1st COVID-19 vaccination shot around 3:30pm. The medical staff had all those being vaccinated to sit for at least 15 minutes for observation to be monitored. I stayed for monitoring for close to an hour (wearing my masks). I felt fine, I noticed my right nostril felt stuffy, congested with a slight burn sensation. I noticed a slight headache when I left. I had about 3 errands to do. 2 hours later I wasn?t feeling well. In addition to a stronger headache my stomach felt queasy. Around 6:30pm I had to pullover to vomit; I threw off my mask and threw up once and then a 2nd time. I sat in my car taking deep breaths until I felt I could make it home. I make it home around 7pm in time to throw up 3 more times, for a total of 5 times. The vomit tasted acidic, sour, citrusy, and metallic at times, and salty. I was only throwing up the vaccine it was mostly clear with white alka seltzer looking deposits. I last ate some crackers around 12 noon. Vomiting is NOT normal for me. I can?t remember the last time I threw up, many many many years ago. l had a headache, queazy stomach, and was exhausted; about 7:30pm tried to sleep. I got up around 10:30pm ate a few saltines and drank a little water but I still didn?t feel good so I didn?t eat anything else. Rough night trying to sleep, tossing and turning. Next day (Thursday day 2) I felt slightly better, not comfortable enough for real food so I drank plenty of water in small amounts and ate saltines; headache subsided. I also had more than usual underarm perspiration with a strong unfamiliar odor. Wednesday, May 19, 2021 1st COVID-19 vaccination shot It appears the vaccine affected my menstrual cycle. My period usually lasts for 3-5 days max, usually light blood flow on days 4 and 5. It was a normal light day 5 when I received the vaccine. After the vaccine, I began having heavy blood flow. The heavy blood flow is accompanied by blood clots. In the past I?ve had a blood clot here and there but not like this. Menstrual blood clots for 9 days after being vaccinated. This is NOT normal for my body. My period was 14 days. Prior to being vaccinated, I NEVER had a period last this long. To my surprise the vaccine affected my female organs. I am right handed, so the nurse recommended using my left arm for vaccination. Left arm where vaccine injected was very sore. Arm pain subsided after 3 days. Pain soreness tension primarily on my left side, shoulder, upper back, chest area. There is a shooting pain on left shoulder, down back to breast, chest heart area; pain comes and goes. Heart palpitations? Experienced this for over a week about 10 days. Numbness in left hand when I sleep on my left side, wake with my left hand numb. Numbness in both hands when I try to sleep on my back. Numbness in my feet after standing for about 15 minutes. Numbness in my leg and buttocks, primarily left side after sitting for an extended period of time. Before being vaccinated I only experienced numbness in my right foot after being on my feet for an extended period of over 4 hours. Last year my right foot/heel would began to hurt after being on my feet for an extended period of time (> 4 hours). Then there would be pins and needles sensation. The solution would be to rest and elevate my feet. I also replaced my shoes (proper support). Post vaccination even before the time my feet would hurt now my right foot goes numb within 30 minutes of standing even while wearing supportive shoes. My left butt cheek goes numb when I am sitting with my legs elevated; this was my most comfortable position pre-vaccination. Since the vaccine my stomach feels upset or unsettled especially in the morning. I am also noticing bloating and more gas than usual. My stomach is also excessively more noisy. Before the vaccine my stomach would make noises when I was hungry or hadn?t eaten, but now there are so many stomach noises almost nonstop all day and night long all the time My nose is feeling congested with a slight burn sensation since getting the vaccination. Immediately after getting the shot my right nostril felt stuffy, congested with a slight burn sensation. This congested feeling comes and goes, especially noticeable when wearing a mask. Prior to being vaccinated I had not experience this issue even as I have worn multiple masks for over a year with NO stuffy nose. Saturday, May 29, 2021 (day 10 post vaccination) I get cold symptoms; runny nose and sneezing. I haven?t had a cold in years; I don?t really get colds; if so the symptoms are mild and quickly dissipate. Now my nose has been running pretty much non-stop causing me to blow my nose just as often. I am also sneezing a lot. This is NOT normal for me. I drank plenty of liquids; however, running nose and sneezing continued leading to hoarse voice. These symptoms prevented me from sleeping. I don?t know if these are cold or allergy symptoms. I had NO allergies before the vaccine. These symptoms finally subsided after 3 or 4 days. My neighbors are waking up in the middle of the night (2am, 3am, 4am, 5am). I began to wonder if I am waking my neighbors possibly with snoring. I don?t really know, no evidence. Throat feels winded and dry when talking especially when I try to whisper. I have to drink a lot of water. Ringing in my ear started In 2019. I thought this phantom sound went away; however, post vaccination I?m hearing the ringing sound again. It seems worse than before. 2018 diagnosed with eye floaters. I am noticing floaters more since getting the vaccine. I usually see the eye floaters when going to light from dark. Post vaccination I am noticing the floaters even in dim light; not normal. I started getting Cold sores in 2006. I thought I had them somewhat under control. Since the vaccine l keep getting cold sores, this may be due to my menstruation. Recently within the past year, my shoulder and elbow joints sometimes make this popping sound when I exercise/move my arm. Post vaccination my shoulders and elbows are making the popping sound every time I move my arm. Now sometimes my knees and ankles are also making a popping .
50 2021-06-09 peripheral swelling potential myocarditis; severe fatigue; SOB; swelling of legs; This is a spontaneous report received ... Read more
potential myocarditis; severe fatigue; SOB; swelling of legs; This is a spontaneous report received from a contactable healthcare professional (patient) via COVAES. A non-pregnant 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 23Feb2021 (at the age of 50 years old; Lot Number: EN6202, unknown expiration) as 1st dose, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL); bupropion hydrochloride (WELLBUTRIN); esomeprazole sodium (NEXIUM); ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTI VIT); and curcuma longa rhizome, piper nigrum fruit (TURMERIC +). The patient experienced potential myocarditis on 15Mar2021. The patient cannot get into cardiology to confirm severe fatigue, SOB, and swelling of legs, which all started on 15Mar2021. The patient underwent lab tests and procedures which included PCR (nasal swab): Negative on 17Mar2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The events resulted in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. The patient had not yet recovered from the events. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Current information is limited and does not allow a full medical assessment. Myocarditis was not a confirmed diagnosis, but rather a provisional diagnosis based on reported symptoms. Case will be reassessed once receiving additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
50 2021-06-10 swelling One day after the second dose I felt a large lump, approximately 14mm right below my clavicle, I'm a... Read more
One day after the second dose I felt a large lump, approximately 14mm right below my clavicle, I'm assuming it was a clavicular lymph node. It has now subsided 30 days afterwards.
50 2021-06-12 peripheral swelling, lymph node swelling Pain left arm and hand 30 seconds post vaccine. Left arm and left axilla swelling and pain 6 hours ... Read more
Pain left arm and hand 30 seconds post vaccine. Left arm and left axilla swelling and pain 6 hours after vaccine. Lymphadenopathy left axilla 6 hours post vaccine. Diarrrhea with blood 6 hours post vaccine. All symptoms have persisted for 3 days. No fever.
50 2021-06-14 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Hyperventilation-Severe, Systemic: Vomiting-Mild, Additional Details: Patient received COVID vaccine. Suspected anaphylaxis and throat swelling and shortness of breath occurred within 1 minute of injection. 911 was called promptly and epipen was administered. first responder on 911 called recommended 324mg aspirin, which was also given. EMTs took patient to hospital and vitals were taken.
50 2021-06-14 lymph node swelling Swollen lymph nodes in the area between my neck and shoulder, swollen lymph nodes in my left armpit,... Read more
Swollen lymph nodes in the area between my neck and shoulder, swollen lymph nodes in my left armpit, swollen lymph nodes in my left breast, swollen lymph nodes in my left groin.
50 2021-06-14 swelling, axillary mass My underarm area and area near my breast became very sore (It hurt to put my arm down) and it appear... Read more
My underarm area and area near my breast became very sore (It hurt to put my arm down) and it appeared swollen and felt lumpy. The lumps seem to have disappeared and it's no longer sore or swollen.
50 2021-06-15 lymph node swelling After the vaccine was given, my heart began racing and I felt flush. I felt like the room was spinni... Read more
After the vaccine was given, my heart began racing and I felt flush. I felt like the room was spinning. The pharmacist took my blood pressure and it was 228/128. My heart rate was 122. My blood pressure is always 120/60. I was trying to call my husband but the room was spinning and I felt like I was going to throw up. I was flushed and my arms and legs felt numb. I was gasping at air because it felt harder to breathe. I tried to stand but had to sit back down. My blood pressure went down after 15 minutes but was still elevated. My heart rate has stayed high. I finally left and when I made it home, I threw up all night. My heart is continuing to be above 100. It has been racing for the past two days. I woke up the past two nights with spitting headaches and my heart rate at 113, 110. I am dripping in sweat both nights which has never happened to me. My glands are now swollen as well and I still feel lousy two days later.
50 2021-06-15 lymph node swelling The first thing I experienced was numbness and tingling on the left side of my face and excessive wa... Read more
The first thing I experienced was numbness and tingling on the left side of my face and excessive watering and irritation in my left eye as well as some pain on the top of my head n the left side. I also had very swollen lymph nodes in my neck on the left side. This lasted for a while. I saw a doctor about it about a week after it. I had dangerously high blood pressure. They sent me home with medication and told me to go to the ER if I had any chest pains. As for the tingling, they initially thought it was shingles. I had some bumps that were painful at the top of my hairline in the left side. I was given something to put on that. I was also sent to the ophthalmologist because my eye was still continuously watering, The tingling went away after another week or so. The swollen lymph nodes came and went for about a month. My eye still continues to have problems. Eventually the ophthalmologist guessed that I had shingles which was probably triggered by the vaccine. I am currently taking a steroid drops in my left eye.
50 2021-06-16 swelling About 30 minutes after injection my arm began to tingle and felt warm on the inside. I figured it wa... Read more
About 30 minutes after injection my arm began to tingle and felt warm on the inside. I figured it was normal, so i ignored it. It continued for about an hour. The following day my elbow ached and was difficult to move, but i figured that might be normal as well. The day after that, i noticed a small lump forming on the muscle of my elbow and it became a bit more painful. I figured it would go away but instead, over the next few days the mass got larger, more painful and I could no longer straighten my arm. I have no insurance and have not been working full time so also had no money, therefore i could not go to a doctor. Several days later I tried to lift a tea pitcher and it felt like something in my arm ripped. I called an urgent care and was told that due to it being vaccine related, they could not treat me. I then went to the health department and was again turned away. My last recourse was the hospital ER. The doctor did an ultra sound and blood tests. She saw the swelling and bruising, she felt the mass under my skin, but could not explain any of them. Since then my arm has develoiped more masses and the pain has spread to the bicep, fore arm and under arm areas.
50 2021-06-17 swollen extremities Edema in both hands and feet with 24 hours of second vaccine,has not resolved as of 17May2021; This ... Read more
Edema in both hands and feet with 24 hours of second vaccine,has not resolved as of 17May2021; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 50-year-old female patient received her second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Lot number: EN6201) administered on the right arm on 19Feb2021 as 2nd dose, single dose (at the age of 50 years old) for COVID-19 immunization. The vaccine was administered in a hospital. The patient's medical history included DCIS breast cancer on 2018 and known allergies to sulfa and sensitivity to gluten. The patient previously received BNT162B2, administered on right arm on 28Jan2021 (Lot number: EL9264), at the age of 50 years old, as 1st dose, single dose for COVID-19 immunization. The patient's concomitant medication included venlafaxine hydrochloride (VENLAFAXINE XR), propranolol, levothyroxine sodium (LEVOTHYROXINE), and biotin. On 20Feb2021, the patient experienced edema in both hands and feet in 24 hours of the second vaccine. There was no treatment given on the event. The adverse event resulted to Doctor or other healthcare professional office/clinic visit. The patient has not had COVID prior to vaccine. The patient has not been COVID tested post vaccination. The outcome for the event was not recovered/not resolved as of 17May2021.
50 2021-06-17 swelling The entire body was swollen. Heart inflammation. Heart ache. Difficulty breating. Dizziness and vert... Read more
The entire body was swollen. Heart inflammation. Heart ache. Difficulty breating. Dizziness and vertigo. The doctor proceeded to take blood work that confirmed heart inflammation doctor recommended meclizine 12.5 mg every day for vertigo and dizziness
50 2021-06-20 lymph node swelling, swelling swollen lymph nodes in neck, and general swelling in neck. this lasted for two weeks. At points duri... Read more
swollen lymph nodes in neck, and general swelling in neck. this lasted for two weeks. At points during that time my lower jaw was numb. Extreme headaches and stiff neck. Headaches would wake me in the middle of the night. Extreme exhaustion. Also I started having extreme digestive problems. Upper abdomen would spasm and go rigid. When this happened my heart would race and my blood pressure would go up. Had two weeks of zero appetite, and had trouble tolerating food for a month.
50 2021-06-20 lymph node swelling i have swelling in cervical lymph node of the neck area and pain in right shoulder
50 2021-06-22 white blood cell count increased Blood in stool/Rectal bleeding in my stool; blood in stool wherein they had to remove her bleeding p... Read more
Blood in stool/Rectal bleeding in my stool; blood in stool wherein they had to remove her bleeding polyp; High white blood cell count/White blood cell count has been like from 24 to 26 all the way up to like 33; Rectal bleeding in my stool; Have lost my 10 pounds; tired; Internal hemorrhage/ internal hemorrhage as well the 'follicles'/Started bleeding pretty bad; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 50 years of age), dose 2 via an unspecified route of administration on 18Mar2021 (Batch/Lot Number: EN6202) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included blood pressure high from an unknown date and unknown if ongoing. Concomitant medication included metoprolol taken for blood pressure measurement, start and stop date were not reported. Historical vaccine included BNT162B2, dose 1 on 25Feb2021 (at 50 years of age) (lot number: EN6202) for COVID-19 immunisation and the patient experienced tiredness. She did not have any other vaccine within four weeks prior to COVID-19 vaccine. The patient reported possible adverse event with the Pfizer COVID-19 vaccine. Throughout the whole pandemic (1.5 years), she hadn't gotten any bloodwork until recently. She said that she had been hospitalized twice. Her first hospitalization was due to the high white blood cell count and the second hospitalization was due to blood in stool wherein they had to remove her bleeding polyp and she would not be discharge because of her high WBC count. When she talked to her blood doctor, her blood doctor told her that she had another patient with the same manifestation, but the other patient had COVID-19. The patient was not sure if she had COVID-19 in the past. She will have more blood work and she will have a biopsy of her bone marrow. In the meantime, she was wondering if it may be an adverse event from the vaccine. She also mentioned that she was part of the clinical trial for the Pfizer COVID-19 vaccine. The patient mentioned that she doesn't know as she had not done blood work since prior to COVID-19 because she hadn't gone to the doctor, so she went to the doctor very recently like at the beginning of May maybe. She guessed that just for something else and she went fasting so they can do routine blood work and incidentally she had a very high white blood cell count (in May2021) and at this point they cannot figure out what was wrong with her. She added that she was very healthy, everything came back pretty normal. She doesn't feel sick, they hospitalized her once for that and then she was hospitalized for (incomplete sentence). She had colonoscopy, she had some issue with (incomplete sentence), they repeated the colonoscopy to put the 'clamp' and then they didn't let her go from the hospital because of the high white blood cell count and so, she guessed she was kind of wondering, if there have been a report on abnormal blood white cell after the Pfizer vaccine and it came earliest thought in her mind today when she was at new doctor who told her about another patient that have high white blood cell count but she had COVID. The patient did not have COVID that she knows, she did not have COVID. The patient added she does not consider it a bad reaction. She mentioned that she was tired. She had undergone multiple blood tests. White blood cell count has been like from 24 to 26 all the way up to like 33. She added that when she originally went to the doctor and when she got this blood work done the first one she was having a little tiny bit of rectal bleeding in her stool and that was because she went to the doctor and she did have a colonoscopy and they basically found some internal hemorrhage as well the follicles and the second time she repeated the blood work, the third time actually she started bleeding pretty bad, so she had to repeat colonoscopy so because of all of this trauma her doctor was repeating the white blood 'sheet' to take blood 'today' to look at her white blood cell a little bit more in depth now that her body was kind of healed for those colonoscopy. She mentioned that now, all this medical test if there was a possibility for her to find out if it could have to do with the vaccine. She added that right now she was 5 feet 6 inches, at that time she was 6 and about 195 pounds. She lost her 10 pounds which the patient commented as "that good news". The patient underwent lab tests and procedures which included biopsy of bone marrow with unknown result on 07Jun2021, blood work and repeated the blood work with unknown result on an unspecified date; Colonoscopy on an unspecified date with unknown result and in May2021 where they found some internal hemorrhage as well the 'follicles'; and white blood cell count: 24 to 26 on May2021 all the way up to like 33 and unknown result on 07Jun2021. The "high white blood cell count" and "Internal hemorrhage/ internal hemorrhage as well the 'follicles' started in May2021 while other events started on an unspecified date. The outcome of the events was unknown.
50 2021-06-24 lymph node swelling Swollen lymph node in arm pit; This is a spontaneous report from a contactable consumer, the patient... Read more
Swollen lymph node in arm pit; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine; Lot number: Ew0151), via an unspecified route of administration to the left arm on 07Apr2021 at 1130 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included Hashimotos. The patient had an allergy to Penicillin. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Concomitant medication included thyroid medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced swollen lymph node in the arm pit on 08Apr2021, the size of a golf ball. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any treatment for the adverse event. The clinical outcome of the event of swollen lymph node was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
50 2021-06-25 swelling face She was given Pfizer vaccination and immediately developed facial swelling and throat tightness. Sh... Read more
She was given Pfizer vaccination and immediately developed facial swelling and throat tightness. She was treated with Benadryl and observed. She came to my office for an allergy consult. Discussed avoiding second dose of vaccine. She complained of paresthesia's and recommended neurology evaluation.
50 2021-06-28 lymph node pain, lymph node swelling by the 9th day I developed excruciating headaches, shooting pain through the left temple to the le... Read more
by the 9th day I developed excruciating headaches, shooting pain through the left temple to the left eye, painful to open and close left eye, a bruise under the left eye and edema under the left eye, arthritic type pains and shooting pains through the body and arms, pains in hands and fingers; pains in the small vessels and big inner and bruises on the right elbow. Toughing veins on the arms and legs is painful. bursting pain behind ears, a mild feeling of angio-edema in my throat, pains lymphatic knots under arms,
50 2021-06-29 lymph node swelling LEFT LYMPH NODE SWOLLEN FEVER CHILLS BOWEL MOVEMENT ISSUE
50 2021-06-29 lymph node swelling felt like spine was being crushed; severe lymphatic swelling in axilla, chest, back and left breast;... Read more
felt like spine was being crushed; severe lymphatic swelling in axilla, chest, back and left breast; fever > 102F with tylenol for over 48 h then remained > 100F for 3 days; debilitating extreme pain in every cell for 24 hours; migraine; sores in mouth; lethargy; lt arm swollen hot, red itchy for a week and a half; lt arm swollen hot, red itchy for a week and a half; This is a spontaneous report received from a contactable other health care professional. A 50-years-old non pregnancy female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6206) via intramuscularly in left arm on 19May2021 07:45 (age at vaccination 50year old) as single dose for covid-19 immunization. Medical history included hypertension, Hypothyroid, High blood sugar TB test from an un-known date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included hctz (HCTZ), metformin (METFORMIN); levothyroxine sodium (SYNTHROID); ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE); olmesartan medoxomil (BENICAR). For all these concomitant products start and stop date and indication were not reported. The patient previously received first dose of BNT162B2 (Lot: EN6199) on 28Apr2021 09:00 AM (age at vaccination 50year old), via intramuscularly, in left arm for covid-19 immunisation. Historical vaccination include flu shot, and patient had history of receiving seldane for unspecified indication. Patient doent had covid prior vaccination and had not tested positive to covid post vaccination. The patient experienced felt like spine was being crushed, severe lymphatic swelling in axilla, chest, back and left breast, fever > 102f with tylenol for over 48 h then remained > 100f for 3 days, debilitating extreme pain in every cell for 24 hours, migraine, sores in mouth, lethargy, lt arm swollen hot, red itchy for a week and a half on 19May2021 19:15. The patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included body temperature resulted as 102 on 19May2021. The clinical outcome of the events recovered with sequelae on unspecified date in 2021. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
50 2021-06-29 peripheral swelling, swelling Swelling in armpit; Swelling neck; This is a spontaneous report from a contactable consumer, the pat... Read more
Swelling in armpit; Swelling neck; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER6213), via an unspecified route of administration in right arm on 18Mar2021 at 16:45 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medication included DUPIXENT for unknown indication, from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 08:00, the patient experienced swelling in armpit and neck on the same side where the shot was administered. It was unknown if the patient received any treatment for the adverse event. The clinical outcome of the event swelling in armpit and neck was not resolved at the time of reporting. No follow-up attempts are needed. No further information is expected.
50 2021-06-29 peripheral swelling Arm, pinky and thumb went numb, red, swollen, pain. Trouble breathing
50 2021-07-01 peripheral swelling pain and swelling in my left breast and left arm; pain and swelling in my left breast and left arm; ... Read more
pain and swelling in my left breast and left arm; pain and swelling in my left breast and left arm; pain and swelling in my left breast and left arm; pain and swelling in my left breast and left arm; pain and swelling in my left breast and left arm; This is a spontaneous report from a contactable nurse (patient). A 50-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9262), via an unspecified route of administration, administered in left arm on 28Jan2021 (age at the vaccination 50-year-old) as second dose single for covid-19 immunisation. Medical history included breast cancer survivor, extreme burning and ongoing swelling (I am a 16-year breast cancer survivor and had extreme burning and swelling at my tumor field). Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (Lot number: EH9899) via an unspecified route of administration, administered in left arm on 07Jan2021 12:00 PM for Covid-19 immunisation. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. if other vaccine in four weeks reported as no. On 28Jan2021 04:45 PM it was reported that patient 16-year breast cancer survivor and had extreme burning and swelling at my tumor field. Even today patient have pain and swelling in my left breast and left arm. Patient did not receive treatment for the adverse events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available currently available the reported events can be considered as an aggravation of the underlying medical condition, nevertheless the contributory role of the vaccine BNT162B2 to this aggravation cannot be excluded because of strong temporal relationship. The case will be reassessed if there is any new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
50 2021-07-01 peripheral swelling Went to had vaccine administered. Swelling in my hands 25 minutes after shot was administered. H... Read more
Went to had vaccine administered. Swelling in my hands 25 minutes after shot was administered. Had already arrived home, called and was transferred to the pharmacy and spoke to pharmacist. Pharmacist asked a series of questions, stated my reaction was not life threatening and recommended Claritin 10mg & Benadryl 50ml and to follow up with my doctor or go to the emergency room if I can't breath. Experienced more swelling in hand, wrists, feet, face tingling, right ear numbness, lips itching/swelling, extremely dry eyes, red eyes, swollen veins in my right eye, blurred vision in right eye, severe headaches, pain in both forearms, sporadic chest discomfort, fatigue, brain fog. Left a message at my doctors office stating my allergic reaction, received a call from nurse practitioner with same over the counter medicine pharmacist suggested plus Pepcid AC 20mg & warm compress. We to see the doctor the following Saturday symptoms hadn't subsided. All my blood work came back normal. Doctor said he hadn't see this before not sure what to do. Possibly steroids but felt my body would adjust. Also went to ER, had chest X-Ray and labs. All came back normal. Called my allergy doctor, also said they didn't know what to do, referred me back to my primary doctor or go to the ER. Went to the ER didn't know what to do and recommended I ask my primary doctor to send me to a cardiologist. I still have same symptoms and same initial over the counter medications. No course of treatment from anyone THEREFORE I told my doctor to refer me to Immunology & Allergy, Cardiologist, and Ophthalmologist. No sense of urgency and I'm awaiting appointments over a month out.
50 2021-07-02 peripheral swelling Pain and swelling in left leg, cannot stand on leg, hurt really bad.
50 2021-07-05 peripheral swelling Pt. went to pharmacy on 6/22/21 to receive the second dose of Pfizer-BioNTech vaccine, lot number E... Read more
Pt. went to pharmacy on 6/22/21 to receive the second dose of Pfizer-BioNTech vaccine, lot number EW0177. The day after the vaccine was administered, her lower arm was swollen, red and her elbow felt hot to the touch. It was too painful to fully extend her arm. There was a white streak across the reddish purple elbow area where it appeared as though there was an infection growing. She went to her normal doctors office, she saw his nurse practitioner who took an x-ray and gave her two intravenous injections of antibiotic (unknown type). One in each buttock and prescribed an oral antibiotic: Cephalexin 500 mg., and Ibuprofen 800 mg. From that day forward she was unable to move the arm at all and the medication did not bring the swelling or the infection down. She was very tired and her arm did not lessen in pain as the days passed. On June 29, 2021 she was in her bedroom and her older daughter was in her room and believed her mother was resting. At approximately 7:20 p.m., pts. husband returned from work and came into the master bedroom turning on the television. As he did so he made joke expecting pt. to laugh or comment, when she made no response he looked over at her and saw that she was laying on the love seat at an awkward angle. He moved to her side and saw her eyes were open but unseeing and saw that her dental prosthetic was partially pushed out of place. He removed and called EMS immediately, not detecting any obvious signs of life. Her daughter came into the room and immediately started CPR. Paramedics arrived in under 2 minutes and moved pt. to the living room where they could intubate a breathing pathway and carried on with attempts to revive her heart muscle for approximately 25 minutes before Paramedic called time of death at 8:02 p.m. Paramedics departed and the Police arrived staying until the Mortuary attendants came to the home at about midnight to accept pt. body for transport to its facility. The Family is seeking an autopsy and the coroner is claiming one is not necessary. The family believes it is absolutely necessary to ascertain whether or not the second dose caused her death as it seems is likely and whether she should have been advised of her heighten risk level. Regardless of COVID 19 Emergency measures, an autopsy is necessary and the family is determined to ensure that it is conducted. Pt. has had a history of the following: Adult onset Asthma, allergic reactions in skin rashes that were significant. Hypothrodism (Graves Disease) which proved to be difficult to find the right meds to bring it under control; prone to incidents of Atrial fibrillation which have escalated as she has aged; she has been treated for emergency visits for Tachycardia; she frequently has developed respiratory issues as a result of the asthma which often landed her in the emergency and days in the hospital on oxygen. She often experienced shortness of breath and chest pain and last year underwent emergency appendicitis. Her last episode of atrial fibrillation which landed in the hospital was 12/29/16. She has been on anticoagulants for many years. Since COVID 19 she may not have been able to afford her Eliquis prescription however which she did not disclose to any of her family members that she was struggling in this wasy. She is likely not to have been taking her Hypothyrodism (Graves) medication either since these medications have not been recovered since her death.
50 2021-07-05 swelling I experienced chest pain, SOB and a swollen back and lung after my second dose vaccine. I want to n... Read more
I experienced chest pain, SOB and a swollen back and lung after my second dose vaccine. I want to notify this for other patients. I lie down on my belly to expand my chest. Today I still have swollen of my left lung side, I believe it is due to the vaccine since it happened few hours after the vaccine. I also have chest pain that I went to the Emergency Room where they performed a chest x-ray, they did not find liquid in my lungs and my lungs are clear. The ER referred me to see a cardiologist. In April 2021 I had a small stroke, where my lips got numb and had very hard chest pain and my arm got sore.
50 2021-07-06 anaphylactic shock Anaphylactic shock 15 minutes after being vaccinated.
50 2021-07-07 anaphylactic shock not taking 2nd dose; lethargic/crash culd not move; anaphylactic shock; difficulty breathing/shallow... Read more
not taking 2nd dose; lethargic/crash culd not move; anaphylactic shock; difficulty breathing/shallow; difficulty breathing/shallow; tongue swollen and felt like bits of glass crystals were pushing out of my tongue for hours, like fiberglass; Severe weakness; shaking; chills; lethargic/crashed could not move; I got sicker and sicker and sicker; unknown collection of autism spectrum neurodevelopmental disorders; dysautonomia & all body systems dys- or mal-regulated and asynchronous; cognitive changes; Increasingly ill; feeling of dis-ease, something very wrong; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 21Apr2021 10:00 (at the age of 50-year-old) at dose 1, single for covid-19 immunisation. Medical history included Autism spectrum conditions (Autism spectrum conditions, but I don't know which genetic disorders or how many). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Yes too many to list here. Prior to vaccination, it was unknown whether the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date in on May2021 the patient experienced an-aphylactic shock, difficulty breathing/shallow, tongue swollen and felt like bits of glass crystals were pushing out of my tongue for hours, like fiberglass, severe weakness, shaking, chills, lethargic/crashed could not move and on 21Apr2021 10:00 unknown collection of autism spectrum neurodevelopmental disorders, increasingly ill, dysautonomia & all body systems dys or mal-regulated and asynchronous, cognitive changes, feeling of disease, something very wrong, i got sicker and sicker and sicker. Increasingly ill to 30 days when I was experiencing such toxicity I called and ambulance & went to ER. dysautnomia & all body systems dys or mal-regulated asynchronous. Cognitive changes, feeling of did-ease, something very wrong not a vaccine cycle of reaction and resolution: I got sicker and sicker and sicker. Acute stage/30 days after: difficulty breathing/shallow, tongue swallow and felt like bits of glass crystals were pushing out of my tongue for hours, like fiberglass; severe weakness, shaking, chills, lethargic/crashed could not move. Patient believe that patient experienced anaphylactic shock response 30 days after my first dose. Patient has an unknown collection of autism spectrum neurodevelopmental disorders and physiological developmental disorders; Autists have unusual and long protein sequences, every-thing is affected. stuck with some effects; not taking 2nd dose, please do better by all the people with genetic conditions and by non-males. Patient did not receive treatment for the adverse events. Adverse events led to the emergency room visit. Outcome of the event not taking 2nd dose was unknown and remaining all the events was resolved with sequel on an unspecified date in 2021. No follow-up attempts are needed. Information on batch/lot number cannot be obtained.
50 2021-07-07 guillain-barre syndrome Admitted after missing dialysis, reporting weakness in early June 2021. Guillian-Barre syndrome ide... Read more
Admitted after missing dialysis, reporting weakness in early June 2021. Guillian-Barre syndrome identified during admission. Currently admitted and receiving IVIG and plasmapheresis. Pt also with CMV colitis and hypotensive
50 2021-07-07 lymph node swelling Swollen lymph nodes in my left collar bone area and under my left armpit.
50 2021-07-07 lymph node swelling Directly after the vaccine, within less than an hour, I experienced a tightness in my throat, and sw... Read more
Directly after the vaccine, within less than an hour, I experienced a tightness in my throat, and swelling of my lymph area around my throat. I still had air, but was concerned for the noticeable tightness of throat which continued for hours. This was better the next day, but since then, I have not stopped ?spotting? in an irregular menstrual spotting and has not ceased. Yesterday however, 7/7/21, I was too tired to keep my eyes open in the afternoon, laid down for a power nap, and there was a noticeable irregular heartbeat twice, in which I was awoken from my nap twice due to what seemed to my heart not beating normally, my chest seemed heavy, and both times after waking from a nap and noticing, I noticed my left arm in the vein area slightly uncomfortable. I have also had to take ibuprofen for a headache yesterday and on one other occasion , and yesterday my lymph in my throat were swollen slightly again- and neither of these symptoms are normal for my own body . I did not get the 2nd dose yet , but due to tightness of throat, I don?t plan to either. I just feel like I should say something.
50 2021-07-08 peripheral swelling Swollen arm; Body ache; headaches; Arm sore; This is a spontaneous report from a contactable consume... Read more
Swollen arm; Body ache; headaches; Arm sore; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8730) via unspecified route of administration in the left arm on 22Mar2021 at 10:00 (at the age of 50-years-old) as a single dose for Covid-19 immunisation. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had not been tested positive for COVID-19 since having the vaccine. It was reported that the patient was on medication for blood pressure and thyroid. On 22Mar2021, the patient experienced arm pain, it was reported that the pain was really sore at upper arm and underneath arm. After 3 days, on 25Mar202, the patient woke up with whole body aching, headache and swollen arm. It was reported that the patient was taking TYLENOL since getting the shot. The clinical outcome of the events arm pain, headache, body ache and swollen arm were unknown. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No follow-up attempts are needed. No further information is expected.
50 2021-07-08 swelling Itch at injection site; swelling; small red splotches noted on right back, right arm, right leg; lar... Read more
Itch at injection site; swelling; small red splotches noted on right back, right arm, right leg; large area on upper arm with raised red patches, and continued itching; large area on upper arm with raised red patches, and continued itching; This is a spontaneous report received from a non-contactable nurse, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL0142), via an unspecified route of administration in the left arm on unspecified date in Jan2021, as a single dose for COVID-19 immunisation. Medical history included allergy (unspecified). Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN), atenolol, chlorthalidone (MANUFACTURER UNKNOWN), and amitriptyline hydrochloride (AMITRIPT): all for unspecified indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in Feb2021, the patient experienced itch at injection site two weeks after vaccination and over 3 weeks swelling and large area on upper arm with raised red patches and continued itching. The patient also experienced small red splotches noted on right back, right arm and right leg. Therapeutic measures were taken as a result of the reported events and included treatment with topical hydro cream with BENADRYL and unspecified oral medication. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the vaccination site pruritus, swelling, patchy rash and red blotches was recovering. No follow-up attempts are possible. No further information is expected.
50 2021-07-09 swelling face within 45 min developed allergic rxn symptoms - throat closing and facial swelling, paresthesia. Ov... Read more
within 45 min developed allergic rxn symptoms - throat closing and facial swelling, paresthesia. Over the following days after vaccine, pt developed muscle weakness, leg stiffness w./ trouble ambulating and chest pains. Using cane to walk at times. Has been on disability since vaccine.
50 2021-07-11 swelling face Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Mild
50 2021-07-13 peripheral swelling I had pained at the vaccination site with swelling and redness. I was fatigue, nausea, headache, ch... Read more
I had pained at the vaccination site with swelling and redness. I was fatigue, nausea, headache, chills, and body aches. I also loss my sense of smell as well. I was in bed for a few days after my shot. I also had brain fogs. I had swelling my lower extremities. I got tress in my mouth for 3 times now.
50 2021-07-13 swelling face, peripheral swelling Multiple complaints: arms turned red when going to bathroom. Went home and felt tire for next 4 days... Read more
Multiple complaints: arms turned red when going to bathroom. Went home and felt tire for next 4 days. 5 days later she had a syncipal event. AMS, BP was 70/50, slurring words. Went to ER - negative CT, MRI, EKG, given 5 bags of fluid. Went home with no dx and slept for 14 hours. woke up with facial swelling. Still has swelling of the arms and hands and a lacy rash. continued fatigue and joint pain.
50 2021-07-13 swelling face Oh I noticed around 11 that I had a very itchy spot on my arms near the injection site but also on m... Read more
Oh I noticed around 11 that I had a very itchy spot on my arms near the injection site but also on my neck, shoulder, my left arm, knees, stomach, breasts, and thighs. I Then check out areas that are itching and is raised urticaria. They got worse over the next few days. I also had some lip swelling and swelling around my jaw as well as some elevated heart rate. I called my doctors office and they prescribed me prednisone for five days to resolve the overactive immune issue. I have this happen a lot.
50 2021-07-13 swelling Swelling and pain in the left arm pit and peck muscle. Causing pain in the chest and difficulty brea... Read more
Swelling and pain in the left arm pit and peck muscle. Causing pain in the chest and difficulty breathing due to pain.
50 2021-07-14 peripheral swelling 50-year-old female while in observation presented with c/o localized burning and swelling on the lef... Read more
50-year-old female while in observation presented with c/o localized burning and swelling on the left arm at the site of injection approximately 5-10 minutes after receiving the first dose of Pfizer. EMS was alerted and patient was then evaluated and observed. Patient's left upper arm continued to swell to her hand and fingers which then progressed to a bluish tint and feel cold to the touch. Patient was recommended to be transported and evaluated further Hospital. Initial Vitals: HR- 74; BP- 183/105; O2 Sat- 98%; RR 22; Discharge Vitals: HR-75; BP- 142/88; O2 Sat-96%; RR-16
50 2021-07-15 lymph node swelling The day after the vaccine I had full body aches, nausea, chills and swollen lymph nodes (left axilla... Read more
The day after the vaccine I had full body aches, nausea, chills and swollen lymph nodes (left axillary & inguinal area). Everything except for swollen lymph nodes was gone in 4 days. The biggest complication is the swollen lymph nodes and an ache in my arm. The ache feels like a tourniquet is on my arm. I just had an ultrasound for my swollen lymph nodes. I saw my primary doctor on 6/23/21. I saw my gynecologist on 6/18/21.
50 2021-07-15 oral herpes Headache, Fever, Sore Throat, aches, pains, exhaustion, cold sores in and around mouth
50 2021-07-17 axillary mass Swelling in the right armpit, close to side of breast.; About 24 hours later a little bit of swellin... Read more
Swelling in the right armpit, close to side of breast.; About 24 hours later a little bit of swelling and aching transferred to left armpit as well.; Low grade fever -elevated just 1 above normal; Fatigue; Shooting pains in ankles and knees; Lessened appetite; slight nausea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the right arm on 27Mar2021 at 16:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included overweight, fatty liver and latex allergy. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), one dose one week prior and lansoprazole (MANUFACTURER UNKNOWN) on an unknown date; both for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the right arm on 06Mar2021 at 15:45 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 17:45, the patient experienced swelling of the right armpit close to side of breast and the swelling was painful. It was significant enough to be obvious through clothing. About twenty-four hours later a little bit of swelling and aching transferred to left armpit as well. The patient also experienced low grade fever (elevated just 1 degree above normal), fatigue, shooting pains in ankles and knees, lessened appetite and slight nausea. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events axillary mass, axillary pain, low grade fever, fatigue, shooting pain, decreased appetite and nausea was recovering at this time of this report. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
50 2021-07-17 lymph node swelling Swollen lymph under left arm; Headache; Body ache; This is a spontaneous report from a contactable c... Read more
Swollen lymph under left arm; Headache; Body ache; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8727), via an unspecified route of administration in left arm on 25Mar2021 at 17:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included that the patient was diagnosed with COVID-19. Concomitant medications included vitamin b12 (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN). The patient was allergic to morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since having the vaccine, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced swollen lymph under her left arm where the vaccine was received and also experienced headache and body ache. The patient had not received any treatment measure for the reported events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of swollen lymph, headache and body ache was unknown at the time of this report. No follow-up attempts possible. No further information expected.
50 2021-07-17 lymph node swelling This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant fe... Read more
This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 07:30 (at the age of 50-years-old) as a single dose for COVID -19 immunization. Medical history and concomitant medications were not reported. The patient had a history of allergy to nuts and narcotics. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 03Mar2021 at 07:15 (at the age of 50-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 13:00 (second day), the patient experienced swollen underarm lymph nodes and rash in legs and arms. No therapeutic measures were taken as a result of the events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of swollen lymph nodes and rash in legs and arms was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
50 2021-07-17 lymph node swelling Burning sensation in mouth; Several canker sores; Red spots in mouth; inflammation on throat; Sore t... Read more
Burning sensation in mouth; Several canker sores; Red spots in mouth; inflammation on throat; Sore throat; Lymph glands swollen; sore on the neck; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) in the right arm on 20Mar2021 at 17:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included controlled high blood pressure. The patient had a history of allergy to penicillin and sulfa. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) and olmesartan (MANUFACTURER UNKNOWN) for high blood pressure. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 19:00, 5 days after the vaccination, the patient experienced burning sensation in mouth, several canker sores appeared on day 6, 7 and 8 (date of this report), red spots in mouth and appearance of inflammation on throat, sore throat, lymph glands swollen and sore on the neck. The patient did not receive any treatment for the reported events. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events burning sensation in mouth, canker sores, red spots in mouth, inflammation on throat, sore throat, swollen lymph glands and sore on the neck was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
50 2021-07-18 c-reactive protein increased I have ongoing joint pain, all over pain like my blood hurts is the inly way to describe it. My dr r... Read more
I have ongoing joint pain, all over pain like my blood hurts is the inly way to describe it. My dr ran lyme tests and inflammatory markers and my C reactive protein was an 18. SED rate was normal. I just have flareups where every part of my body is in pain. I am going to seee a rheumatologist 7/20
50 2021-07-18 c-reactive protein increased SO after the second shot I had a very sore left arm. Within six hours I had a lot of pain in all of ... Read more
SO after the second shot I had a very sore left arm. Within six hours I had a lot of pain in all of my joints and muscles. On day two I woke up with a fever of 102.1, a massive migraine and nausea, vomiting and that lasted for about three days. Around day four everything went away except the joint pain. My pain level is always between a 4-6 now, prior to that it was a 6-8 and that is when I sought treatment from a DR. I contacted my DR about a week after my vaccine. I saw a Rheumatologist and got blood work too. I also am having short term memory problems as well which has begun after the vaccine as well so I do not know the time frame too well of everything that has happened. I do have two DRs coming up for both wrists and my knee, those are to be scheduled. I have been issues with working as well. I am very fatigued, have issues with short term memory loss and work retrieval, issues getting dressed in the morning due to joints being cramped.
50 2021-07-18 lymph node swelling Headache, unable to sleep at night, back pains, pains in arm, body pain , pain in right breast, wake... Read more
Headache, unable to sleep at night, back pains, pains in arm, body pain , pain in right breast, wake up with pain on side of face, swollen lymph node in breast
50 2021-07-19 peripheral swelling Fever; fatugue; body aches for 36 hours; swollen and itchy arm for 3 days which later resolved into ... Read more
Fever; fatugue; body aches for 36 hours; swollen and itchy arm for 3 days which later resolved into swollen; swollen and itchy arm for 3 days which later resolved into swollen; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; This is a spontaneous report from a contactable consumer (Patient). A 50-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 10:15 (at the age of 50-years-old) as dose 2, single for covid-19 immunization. Medical history included allergy to arthropod bite from an unknown date (fire ant allergy). Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (MINASTRIN 24 FE). cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin, amoxicillin, neosporin bacitracin neomycin sulfate polymyxin b sulfate] and experienced allergy. The patient took first dose of bnt162b2 (Lot number: EP6955), via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:15 as dose 1, single for covid-19 immunization. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 14Apr2021, the patient experienced Fever, fatigue, and body aches for 36 hours, swollen and itchy arm for 3 days which later resolved into swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks. The patient did not received treatment for adverse events. Outcome of events was recovered on unspecified date of Apr2021. No follow-up attempts are needed. No further information is expected.
50 2021-07-19 swelling Immediate allergic reaction to first dose of vaccine, tongue swelled, could not swallow, face hugely... Read more
Immediate allergic reaction to first dose of vaccine, tongue swelled, could not swallow, face hugely flushed, unusual allergic reaction compared to past. Was a drive-thru clinic in early January, and there were no medical staff present, no epi pen administered. 8 minutes later, the reaction began to pass, waited for another hour and the symptoms subsided somewhat. 3-4 swelling in neck, fatigue, issues affecting voice box, etc. Slowly has dissipated over time. Doctor recommended not to get the second vaccine, due to allergic reaction.
50 2021-07-20 lymph node swelling Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: SWOLLEN RIGHT BREAST ... Read more
Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: SWOLLEN RIGHT BREAST WITH RASH RUNNING DOWN CENTER OF BREAST-Severe, Systemic: Lymph Node Swelling-Medium, Additional Details: POST MASTECTOMY RIGHT BREAST BECAME SWOLLEN WITH RED RASH RUNNING LENGTH OF RIGHT BREAST. "HARD AS A ROCK" SOME SWELLING OF LYMPH NODES AND SHARP PAIN
50 2021-07-21 swelling Lump on collarbone or neck; This is a spontaneous report from a non-contactable consumer, the patien... Read more
Lump on collarbone or neck; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 01Apr2021 at 14:00 (at an age of 50-year-old) as single dose for COVID-19 immunisation. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route in left arm on 14Mar2021 at 16:00 hours as single dose for COVID-19 immunisation. The patient had known allergy to Morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.Post the vaccination, the patient was not tested for COVID-19. On 02Apr2021 the patient had lump on collarbone/neck. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the event of lump on collarbone or neck was not resolved at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained.
50 2021-07-21 white blood cell count increased Appendicitis, perforated appendix (maybe caused by swollen lymph nodes from vaccine?) Appendectomy 4... Read more
Appendicitis, perforated appendix (maybe caused by swollen lymph nodes from vaccine?) Appendectomy 4 day hospital stay with IV antibiotics 7 week recovery at home
50 2021-07-22 lymph node swelling Two days after the vaccine I noticed a bump on my left shoulder near my clavicle. My provider identi... Read more
Two days after the vaccine I noticed a bump on my left shoulder near my clavicle. My provider identified it as a lymph node. I had one Lymph node removed after investigation. There were two lymph nodes that were inflamed. I got an Ultrasound and a CT scan, and I had the Lymph Node removed 02/04/2021 which was within two weeks of my vaccine.
50 2021-07-22 swelling, lymph node swelling On day 3 after receiving the second dose of the Pfizer vaccine, all the lymph nodes on the left side... Read more
On day 3 after receiving the second dose of the Pfizer vaccine, all the lymph nodes on the left side of my body from behind my ear, down my jawline, down my neck, under my arm,; my upper torso well all enlarged and swollen; fever of 101 and was completely exhausted; completely exhausted; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration, administered in Left Arm on 15Apr2021 09:15 AM (at the age of 50 years old) as DOSE 2, SINGLE for COVID-19 immunisation at Pharmacy or Drug Store. Medical history included malignant melanoma (recovered). The patient has known allergies to Iodine, codeine, Cephdiner. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Device Date was reported as 12Jul2021.Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY); ascorbic acid, betacarotene, biotin, calcium carbonate, calcium phosphate, chlorine, colecalciferol, cupric oxide, ferrous fumarate, folic acid, iodine, magnesium oxide, manganese sulfate, molybdenum, nickel sulfate, nicotinamide, pantothenic acid, phosphorus, potassium chloride, pyridoxine hydrochloride, retinol acetate, riboflavin, selenium, silicon, thiamine, tin, tocopherol, vanadium, vitamin b12 nos, zinc oxide (MULTIVITAMINS AND MINERALS PLUS LUTEIN) and Birth control. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: unknown), as first dose in arm Left on 17Mar2021 as dose 1, single for COVID-19 immunization. On 18Apr2021, day 3 after receiving the second dose of the Pfizer vaccine, all the lymph nodes on the left side of my body from behind my ear, down my jawline, down my neck, under my arm, my upper torso well all enlarged and swollen. I had a fever of 101 and was completely exhausted. This lasted for 10 days before she started feeling better. The fever would come and go. No treatment was received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included pyrexia: 101 Fahrenheit on 18Apr2021. The outcome of the events was recovered on an unspecified date in 2021. Was requested for additional information Information about lot/batch number is requested.
50 2021-07-22 swelling Patient came into clinic today around 2:15pm on 07/23/2021 and informed staff that within 24 hours o... Read more
Patient came into clinic today around 2:15pm on 07/23/2021 and informed staff that within 24 hours of receiving dose #2 Pfizer COVID-19 vaccine that she experienced Left arm pain, swelling to her left shoulder/neck area that last 2 days, a d fever times 1 day and nausea times 1 day. Patient stated that swelling went away after 2 days.
50 2021-07-23 lymph node swelling Tumor in muscle of uterus area; Lymph nodes swollen; Chest pressure; trouble breathing; Bloodwork is... Read more
Tumor in muscle of uterus area; Lymph nodes swollen; Chest pressure; trouble breathing; Bloodwork is showing certain levels high; tired; forgetful; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3249), via an unspecified route of administration in arm left on 20Jan2021 at 14:00 (at the age of 50-year-old) as a dose 1, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration in arm left on 20Jan2021 at 14:00 (at the age of 50-year-old) as a dose 2, single for COVID-19 immunisation. The patient's medical history and concurrent conditions included herniated disks. The patient's concomitant medications received within 2 weeks of vaccination included gabapentin and oxycodone hydrochloride, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]). It was reported that, the patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On 01Feb2021 at 14:00, the patient experienced tumor in muscle of uterus area, lymph nodes swollen, chest pressure, trouble breathing, tired, forgetful. Bloodwork was showing certain levels high. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No prolonged hospitalization. Treatment received for the events was surgery. On 01Feb2021, the patient underwent lab tests and procedures which included bloodwork, resulted as high, certain levels high. The device date was on 11Jul2021. The outcome of the events was not recovered.
50 2021-07-25 swelling Soreness, swelling, headache, chills, fever, body aches, joint pain, muscle pain, runny nose, fatig... Read more
Soreness, swelling, headache, chills, fever, body aches, joint pain, muscle pain, runny nose, fatigue, upper and middle back ache, chest pain, and dizziness.
50 2021-07-26 c-reactive protein increased Inflammation throughout entire body, arthritic response in 2 fingers on right hand, pain in both upp... Read more
Inflammation throughout entire body, arthritic response in 2 fingers on right hand, pain in both upper thighs, at times to the point I could not stay still, Significant change in thyroid function lab tests. Extreme fatigue and continuous headaches.
50 2021-07-26 swelling APPROXIMATELY 5 TO 10 MINUTES AFTER SHOT, PATIENT COMPLAINED OF CRAMPING/PAIN IN FACE AROUND EAR. SW... Read more
APPROXIMATELY 5 TO 10 MINUTES AFTER SHOT, PATIENT COMPLAINED OF CRAMPING/PAIN IN FACE AROUND EAR. SWELLING AT BASE OF NECK AND BURNING IN CHEST AND BREAST AND TINGLING IN FINGERS AND HAND, ALL OF THIS ON LEFT SIDE WHERE SHOT WAS ADMINISTERED. PATIENT GIVEN AN ICE PACK TO APPLY TO SWELLING AND OBSERVED FOR AT LEAST 30 MINUTES. SWELLING WENT DOWN, PATIENT WAS OFFERED BENADRYL BUT DID NOT WANT TO TAKE UNTIL SHE GOT HOME. NO DIFFICULTY BREATHING OR PRESSURE IN CHEST. NO CHANGE IN MENTAL OR ALERT STATUS.
50 2021-07-27 lymph node swelling, lymph node pain Tender lymph node under left arm; Swollen lymph node under left arm; This is a spontaneous report fr... Read more
Tender lymph node under left arm; Swollen lymph node under left arm; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER7533) via an unspecified route of administration in the arm left on 30Mar2021 at 10:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included birth control pills (unspecified), ademetionine (SAM-E),LUTEIN (unspecified), magnesium (MANUFACTURER UNKNOWN) and Bu (unspecified); all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received minocycline (MANUFACTURER UNKNOWN), amoxicillin (MANUFACTURER UNKNOWN), ciprofloxacin (CIPRO); all started on an unknown date for an unknown indication and experienced allergy with all. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 19:00, the patient experienced swollen and tender lymph node under left arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events swollen lymph node under left arm and tender lymph node under left arm were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
50 2021-07-27 lymph node swelling, swelling injection site painful; Muscle pain; tiredness; felt drained of energy/weak; joint pain; that felt l... Read more
injection site painful; Muscle pain; tiredness; felt drained of energy/weak; joint pain; that felt like it was down to the bone marrow; swelling of lymph nodes in neck; Hoarseness; chills; fever; sore throat/throat soreness; vaccine made her sick as a dog; had the shits; she cannot even talk right; head and throat it feels swollen up; head and throat it feels swollen up/her throat was swole; I have, I called in, I do not remember yesterday, day before yesterday I believe. I do not remember what day it was; vision is blurry; This is a spontaneous report from a contactable consumer or other non-Health Care Professional (patient) via medical information team. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0186 and Expiry date: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 19May2021 12:23 (at the age of 50-years-old) as dose 1, single for Covid-19 immunization in Vaccination Facility Type School/Student Health Clinic. The patient medical history included 12 broken ribs, family medical history and concomitant medications were reported as no. History of all previous immunization with the Pfizer vaccine considered as suspect none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no problems with vaccines in past. The patient was not diagnosed with covid 19 and has not been tested for COVID-19 Since the vaccination. It was reported that patient experienced severe side effects after receiving first dose of vaccine. On an unspecified date in 2021, the patient experienced vaccine made her sick as a dog, her throat was swole, she cannot even talk right, Vision was blurry it was going and coming she never had a problem with my eyes, had the shits. On May2021 the patient experienced chills, fever, joint pain; that felt like it was down to the bone marrow, swelling of lymph nodes in neck, hoarseness, throat soreness that made her feel like she had a cold or some allergies. She was sick like a dog, head and throat it feels swollen up. On 19May2021 the patient experienced injection site painful, muscle pain, tiredness, felt drained of energy/weak. Patient stated that "I have, I called in, I do not remember yesterday, day before yesterday I believe. I do not remember what day it was but this my head, is this, this feels really, my head and throat it feels swollen up and I feel weak and yes my vision is blurry it's going and coming I never had a problem with my eyes. I need to go to work." Regarding medication patient stated that "I was taking, I only took from a lady that tried to help and 'nothing happened itself' (not clear) I didn't took (voice incomprehensible), I didn't took, it seem like I got a cold or something I don't know what is it. It's like my sinus and all of it and all this other, It's got my swollen throat and all of it, it messes with my vision. I got my throat is swelled up, my throat is swelled up and I am just thinking about." The report was not related to a study or program. The patient questioned that was the Pfizer covid-19 vaccine prohibited but being given anyway. Patient stated she has not established a new doctor yet since moved. Was told that her arm was going to be painful after the injection and that was normal, but what she had was not normal and different from the sheet she was given. Had all those side effects except she did not get any headaches. All of these are gone except for the swelling on her lymph nodes in neck. Thought that was what has got her hoarse, was her lymph nodes in the throat swollen. It started with soreness and made her feel like she had a cold or some allergies. She was sick like a dog, but all that is gone today and she was starting to feel better, she just has the hoarseness. Started to feel better last night between 6-8pm and went to sleep about 8-8:30pm and did not wake up until this morning. She woke up this morning and all the symptoms even in the arm was better, but she was hoarse. Her throat was not sore anymore, but still has lymph node swollen in throat. Has not seen a provider or emergency care, states a family member cared for her. Patient did not visit emergency room or physician office. The seriousness was unspecified. No investigation assessment were done and relevant tests were none. The outcome of events was unknown. Follow up attempts are needed. Further information has been requested.
50 2021-07-27 lymph node swelling Gums on right lower jaw is swollen, painful, tender to touch and is red; Gums on right lower jaw is ... Read more
Gums on right lower jaw is swollen, painful, tender to touch and is red; Gums on right lower jaw is swollen, painful, tender to touch and is red; Gums on right lower jaw is swollen, painful, tender to touch and is red; Pain in the jaw; lymphnodes could be a littlie swollen on the right side in the tonsil area; Little problem with breathing.; right arm at the injection site, is red, the size of quarter or dollar coin and hot,warm to the touch, pain is tolerant; Right arm at the injection site, is red, the size of quarter or dollar coin and hot,warm to the touch, pain is tolerant; Indigestion; Nausea; could not lay down straight; injection area is the size of a dollar coin and is red; injection area is the size of a dollar coin and is red; Feeling of Indigestion, upset stomach, not feeling herself; Wheezing; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6204; Expiration Date: 31Jul2021), via an unspecified route of administration in right arm on 12Mar2021 at 14:00 as single for covid-19 immunization. Medical history included arthritis from Sep2009 to an unknown date, covid-19 from Oct2020 to an unknown date, she stated that she had Covid in October and has lingering effects, such as wheezing and cough attacks but nothing too extreme. Concomitant medications included serratiopeptidase (SERRATIOPEPTIDASE) for wheezing, from Feb2021 to ongoing, found nodules on the x ray-why that was taking it; meloxicam for an unspecified indication from Sep2020 and ongoing for arthritis, 15mg once a day by mouth, ipratropium bromide, salbutamol sulfate (COMBIVENT) from Feb2021 to ongoing, at 2 sprays, inhalations in the morning, 1.68mg 8.77mg, 1ml for wheezing, started when she got Covid and started it again as regimen for wheezing. She stated that she takes an anti-inflammatory for her arthritis as a preventative. The patient not had history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She reported she got the vaccine on the right side. She reported her gums on right lower jaw was swollen, painful, tender to touch and was red, pain in the jaw and lymphnodes could be a littlie swollen on the right side in the tonsil area, stating this started on Saturday, 13Mar2021. Caller reported that she took naproxen 600 mg. She reported that she did not have symptoms on friday but woke up in the middle of the night and had indigestion/nausea on 12Mar2021. She stated that she had covid in October and was being treated for wheezing. She stated that she could not lay down straight and was very uncomfortable. She stated that the injection area was the size of a dollar coin and was red. She wanted to know if she should go to the dentist. She stated that she received the vaccine on Friday afternoon and she was having some symptoms. She stated that she doesn't know if it was a coincidence or not. She stated that on Friday she felt ok and came home and laid down. She stated that during the night, she doesn't know what time, she had what felt like indigestion but she didn't have a dinner or anything heavy to eat that night. She has an upset stomach doesn't feel herself. She also stated that she felt, not like a hard time breathing, but wheezing. Wheezing AE was started since recovering from Covid on Mar2021. She stated that on Saturday when she woke up, her gums on the right side were swollen. She stated that on her arm she noticed at the injection site, it was red, the size of quarter or dollar coin and hot, warm to the touch, the pain was tolerant. She stated that she was not sure if it was a coincidence or not because they did say something about the lymphnods and that may have something to do with her gums. Right arm at the injection site, was red, the size of quarter or dollar coin and hot, warm to the touch, pain was tolerant. She clarified that the upper part of her arm was white and she can see a red spot the size of a dollar coin. She felt nauseous on Saturday morning and her gums became swollen in the evening. Vaccine site on her arm was painful, a bit red, elevated and warm to the touch. She also has a little problem with breathing. She stated that she was supposed to go back at the end of March to her physician for a checkup for her Covid. She had an x-ray last time and was put on a medication and inhaler for her wheezing. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Oct2020. She took Naproxen (Expiration: Jul2021 Lot: 0CR0377) 600mg three times a day on Saturday and Sunday but her gums are still swollen, tender to the touch and bothersome. No family medical history relevant to adverse events was provided. The patient did not visit emergency room or physician office, she stated that she may need to go see dentist for her gums. The outcome of gingival pain was unknown, while with other events was not recovered No follow-up attempts are needed. No further information is expected.
50 2021-07-27 lymph node swelling mildly enlarged axillary lymph nodes; Pain radiating to entire arm and hand; Very intense pain at in... Read more
mildly enlarged axillary lymph nodes; Pain radiating to entire arm and hand; Very intense pain at injection site; Pain radiating to entire arm and hand; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL8982) via an unspecified route of administration in the left arm on 28Jan2021 at 14:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis and penicillin allergy. Concomitant medications were reported as not applicable. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3248) via an unspecified route of administration in the left arm on 08Jan2021 at 14:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 29Jan2021 at 02:00, approximately 12 hours after injection of 2nd dose, the patient experienced very intense pain at injection site and the pain radiated to entire arm and hand. The intense pain persists at injection site over 2 months post injection. The pain in left arm was causing limited motion range. Occasionally mostly during the night, very intense pain reoccurs at the time of report. On an unknown date in Feb2021, the patient experienced mildly enlarged axillary lymph nodes. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. On an unknown date in Feb2021 one week after 2nd dose, the patient underwent routing breast ultrasound screening and the result was mildly enlarged axillary lymph nodes. The clinical outcome of the events very intense pain at injection site, pain radiating to entire arm and hand, enlarged axillary lymph nodes was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
50 2021-07-27 lymph node swelling Swollen lymph node in left armpit; Soreness in left arm; This is a spontaneous report from a contact... Read more
Swollen lymph node in left armpit; Soreness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration on 28Apr2021 at 08:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW011A) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 16:30 the patient experienced swollen lymph node in the left armpit and soreness in the left arm. There was no information regarding the events whether resulted in doctor or other healthcare professional office/clinic visit, and the emergency room/department or urgent care. The clinical outcome of the events swollen lymph node in left armpit and soreness in left arm were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
50 2021-07-27 lymph node swelling swollen lymph node under left arm; tiredness; dizzy; soreness in shoulders up neck and back of left ... Read more
swollen lymph node under left arm; tiredness; dizzy; soreness in shoulders up neck and back of left side of head; soreness in shoulders up neck and back of left side of head; This is a spontaneous report from a non-contactable consumer, the patient. A 50-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 29Mar2021 at 10:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included Covid-19. The patient previously received cyclobenzaprine hydrochloride (FLEXERIL) on an unspecified date for an unknown indication and experienced drug allergy. Concomitant medications included allergy medicine from an unknown date for an unknown indication. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Mar2021 at 11:00, the patient experienced swollen lymph node under left arm, tiredness, dizzy, soreness in shoulders up neck and back of left side of head. No therapeutic measures were taken as the result of the reported adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swollen lymph node under left arm, tiredness, dizzy, soreness in shoulders up neck and back of left side of head were resolving at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
50 2021-07-27 swelling face I had an allergic reaction after the first dose, swollen face, itchy body and face. Headache.; I had... Read more
I had an allergic reaction after the first dose, swollen face, itchy body and face. Headache.; I had an allergic reaction after the first dose, swollen face, itchy body and face. Headache.; I had an allergic reaction after the first dose, swollen face, itchy body and face. Headache.; I had an allergic reaction after the first dose, swollen face, itchy body and face. Headache.; This is a spontaneous report from a contactable consumer (Patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date: was not reported ), dose 1 via an unspecified route of administration, administered in Arm Right on 19May2021 at 13:30 ( Age at vaccination: 50 years) as dose 1, single for covid-19 immunisation. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. The patient was previously diagnosed with COVID-19, and since the vaccination the patient tested for COVID-19. Concomitant medications were not reported. The patient previously took Penicillin, Codeine phosphate (CDOEIN) and acetylsalicylic acid (ASPIRIN E.C) and had Drug allergy. It was reported that she had an allergic reaction after the first dose, swollen face, itchy body and face and headache on 19May2021 at 17:00. The patient underwent lab tests and procedures which included sars-cov-2 test which was negative on 06Apr2021 Nasal Swab. The outcome of the events was recovering. Information on the lot/batch number has been requested.
50 2021-07-28 lymph node swelling, peripheral swelling left breast swollen; Numbness in both hands; Both hands swollen; Coughing; Super weak; Really tired;... Read more
left breast swollen; Numbness in both hands; Both hands swollen; Coughing; Super weak; Really tired; Severe headache; Left Armpit swollen and shooting pain; The shot site(upper left arm) started hurting within 12 hours and could not touch or sleep on left side; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150) via an unspecified route of administration in the left arm on 04Apr2021 at 12:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient reported of no known allergies to medications, food, or other products. Concomitant medications included paracetamol (TYLENOL EXTRA-STRENGTH) and clonazepam (MANUFACTURER UNKNOWN) 1mg three times a day and more pharma (unspecified) for an unknown indication and from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 within 12 hours after vaccination, the patient experienced shot site hurting (upper left arm) and reported that she could not touch or sleep on the left side. The patient reported that it did hurt when she tried to use her left arm. On 05Apr2021 at 20:00, the patient experienced left armpit and breast swollen and shooting pain, numbness in both hands, both hands swollen, coughing, super weak, really tired and severe headache. It was unknown if any therapeutic measures were taken as a result of the reported events. The event resulted in doctor or other healthcare professional office/clinic visit on 06Apr2021 at 14:45. The clinical outcome of the event left armpit and breast swollen and shooting pain, numbness in both hands, both hands swollen, coughing, super weak, really tired, severe headache and shot site hurting were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
50 2021-07-28 lymph node swelling The first shot was March 23, 2021 and I woke up with extreme pain down my right leg that early morni... Read more
The first shot was March 23, 2021 and I woke up with extreme pain down my right leg that early morning after the shot. It eventually didn't ache as much until I received my second shot April 13 th and then both my legs started to ache badly mostly during the night. I now remember that my first shot was in my right arm and my second shot was in my left arm. I had my mammogram done April 15th and they recognized enlarge lymph nodes under my right arm. They immediately scheduled a biopsy because this was never in my medical history. I had to first get an ultra sounds and then a biopsy. My legs continued giving me pain so, my Dr. prescribed meds for the inflammation and recommended I get a doppler done on my legs. During the doppler the first part of June, they saw two other swollen lymph nodes on the left and right of my groin area. The right side was larger. So, I went back to my doctor and then he ordered a CT scan to be done to make sure the lymph nodes were not cancerous. I got the CT scan in July 26th and by that time the lymph nodes were no longer swollen. My scan was considered normal.
50 2021-07-28 swelling, peripheral swelling After about 5-10 minutes after receiving the vaccine, patient stated that her arm started to feel li... Read more
After about 5-10 minutes after receiving the vaccine, patient stated that her arm started to feel like it was becoming swollen. Patient was monitored and Benadryl and EpiPens were prepared. Patient wanted to take the Benadryl and took 2 25mg caps. Patient had not eaten or drank anything prior to shot and water was provided. Pt became nauseas and described chest tightness and threw up both Benadryl caps as well as the small amount of water that she drank. BP ~160/110, HR: 65 after vomiting. EMS services arrived, and the patient was brought to the hospital for further evaluation
50 2021-07-29 lymph node swelling had a sore throat; chills; had a swollen lymph node on neck; This is a spontaneous report from a con... Read more
had a sore throat; chills; had a swollen lymph node on neck; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on an unknown date (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and past drug therapy. The patient did not take any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 22Apr2021, the patient experienced sore throat and chills for a few hours and swollen lymph node on the neck. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood test on an unknown date and was waiting on results and COVID-19 test on an unknown date and the results were unknown. The clinical outcome of the events sore throat and chills was recovered on an unknown date in Apr2021 and the outcome of the event swollen lymph node on the neck was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
50 2021-07-29 oral herpes soreness at injection site; Joint pain; headache; excessive thirst; cold sores all over lips; scratc... Read more
soreness at injection site; Joint pain; headache; excessive thirst; cold sores all over lips; scratchy throat; mild post nasal drip; This is a spontaneous report from a contactable other healthcare professional, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Apr2021 at 10:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included mild congenital pulmonary stenosis, chronic dry eye syndrome, and other food allergies all from an unknown duration. The patient previously took erythromycin (MANUFACTURER UNKNOWN), BACTRIM and doxycycline (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication and experienced allergy to these drugs. Concomitant medications included ethinylestradiol; segesterone acetate (ANNOVERA), calcium citrate; magnesium citrate (MAG CITRATE), ascorbic acid (VITAMIN C), curcuma longa (TURMERIC), and docosahexaenoic acid (DHA), vitamin B (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN); all taken for an unknown indication and received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 03Apr2021, the patient experienced joint pain, headache, excessive thirst, cold sores all over lips, scratchy throat, and mild post nasal drip all these symptoms lasting through the fourth day and also experienced soreness at injection site which was mild and last two days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events joint pain, headache, excessive thirst, cold sores all over lips, scratchy throat, and mild post nasal drip was not recovered at the time of this report and that of soreness at injection site which was mild was recovered on 05Apr2021. No follow-up attempts are needed; information about lot/batch number cannot be
51 2020-12-31 lymph node pain, lymph node swelling *12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, ... Read more
*12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, with pain, on Right side of body with increased sensitivity at Left Axillary/side of breast area. Onset on 12/30 Fever, Severe Body aches/joint pain, dry cough, chest pain with min SOB, Headache. *Exposure to 4 people on Sat 12/26 who have tested positive for Covid on 1/1/20 but their symptoms began 12/28 through 01/30.
51 2020-12-31 lymph node swelling on 12/25 all lymph nodes on the same side as the shot injection swollen, Joint Pain, not w=feeling w... Read more
on 12/25 all lymph nodes on the same side as the shot injection swollen, Joint Pain, not w=feeling weel. on 12/31 reported that the lymph nodes near clavicle have now swelled. The other lymph nodes have not ceased being swollen.
51 2021-01-04 anaphylactic reaction Headache, Anaphylaxis, UrticariaPruritus & NauseaVomiting
51 2021-01-04 lymph node swelling Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clav... Read more
Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clavicular probable lymph node which is large and painful. Possible neck lymphadenopathy as well.; Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clavicular probable lymph node which is large and painful. Possible neck lymphadenopathy as well.; Experienced numbness and tingling in left arm on day 1 which resolved; Experienced numbness and tingling in left arm on day 1 which resolved.; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 10:30 AM at left arm, at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and known allergies to amoxicillin. The patient was not pregnant at the time of vaccination. The patient experienced numbness and tingling in left arm on day 1 (23Dec2020) which resolved in Dec2020. 3 days later noted left clavicular probable lymph node which is large and painful on 25Dec2020 07:00 PM. Possible neck lymphadenopathy as well. No treatment was received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events numbness and tingling in left arm was recovered in Dec2020. The outcome of the other events was not recovered. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information about lot/batch number has been requested.
51 2021-01-04 swelling face lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/... Read more
lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; swelling in face; swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 28Dec2020 03:30 PM at single dose (lot number: EH9899) for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products. Concomitant medications include Estradiol received in two weeks. No other vaccine in four weeks. The patient was not pregnant. The patient experienced lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here that resembled sunburn, but was not painful; on 28Dec2020 04:00 PM. The patient took antihistamine (Claritin) and rest as treatment. All events were reported as non-serious. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovering.
51 2021-01-04 swelling face swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), to... Read more
swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ek5730, via an unspecified route of administration on 30Dec2020 at 12:00 (at the age of 51 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included lupus from an unknown date, and allergy to Celebrex (itching). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL), levothyroxine, vitamin D3, and zinc, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 30Dec2020 at 14:30, the patient experienced swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands. The patient received treatment for the events which included Pepcid, Benadryl and prednisone. The clinical outcome of swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
51 2021-01-05 lymph node swelling, lymph node pain felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling ... Read more
felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling going down arm/ tingling down to her fingers; A little nausea/nauseated; real tired/ exhausted; muscle aches, just achy feeling; a little dizzy; sinus congestion; feel bad enough; didn't have enough energy; swollen lymph node; its like a little bitty lump in her throat; lymph node's a little bit tender; stated that her head feels congested almost like sinus pressure; stated that her head feels congested almost like sinus pressure; This is a spontaneous report from a contactable nurse reported for self. This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 29Dec2020 15:15 at single dose for covid-19 immunisation. Medical history included migraine, stated that the pressure triggers migraines and she was not going there. Concomitant medications were not provided. Past drug history included stated she took Excedrin migraine because she has history of migraines. She stated it felt like she had the flu, didn't have a temperature and never had a temperature. The first symptom was a dry cough and arm hurt so bad it was tingling going down arm/ tingling down to her fingers and now it felt much better and was able to move. A little nausea/ nauseated, kind of like flu symptoms, was real tired/ exhausted, muscle aches, just achy feeling. She was going to get up and go to work but felt the same symptoms but a little dizzy. Right now, she was feeling a little better but she had this like sinus congestion and the dry cough. She felt bad enough and didn't have enough energy to attend her aunts funeral and was fine yesterday. She also had a little bit of a swollen lymph node. She was not having difficulty breathing or anything like that. She was trying to eat something and its like a little bitty lump in her throat and her lymph node's a little bit tender." She stated she was starting to feel tired. Stated right now head feels congested almost like sinus pressure. Stated she does not have a headache. Stated that she does not have a temperature. Stated that she feels like crap. Stated that she called the nurse at the hospital and she stated that with the vaccination some people are testing positive for Covid. Stated that she was told that if she was having symptoms that she should go get a Covid test. Wanted to know if she should get a Covid test. Wanted to know if she should get the rapid test or 3 day. Outcome of the events felt like she had the flu/ kind of like flu symptoms, dry cough, arm hurt, tingling going down arm/ tingling down to her fingers, nausea, real tired/ exhausted, muscle aches, just achy feeling, a little dizzy, was recovering. Outcome of the event sinus congestion, feel bad enough, didn't have enough energy, swollen lymph node, its like a little bitty lump in my throat, lymph node's a little bit tender, her head feels congested almost like sinus pressure was unknown. Information on the Lot/batch number has been requested.
51 2021-01-06 lymph node swelling had, headache, body aches, chills ,GI upset, heartburn, sweats the next day. then 2 days later had ... Read more
had, headache, body aches, chills ,GI upset, heartburn, sweats the next day. then 2 days later had loose stools, day 3 swollen lymph nodes in my next. day 4 rash on my back that was red, itched, burned . went away about 12 hours after they came.
51 2021-01-07 lymph node swelling Soreness in left arm at injection site similar to receiving flu vaccine. On 1/7/21 I had a headache,... Read more
Soreness in left arm at injection site similar to receiving flu vaccine. On 1/7/21 I had a headache, stiff/achy neck and shoulders and some chills. Upon waking on 1/8/21 my left armpit is sore and swollen.
51 2021-01-07 lymph node swelling injection site pain, lymphadenopathy Narrative: 12/18 received the vaccine. 12/19 injection site a... Read more
injection site pain, lymphadenopathy Narrative: 12/18 received the vaccine. 12/19 injection site and upper arm pain. 12/20 onset of supraclavicular lymphadenopathy. Still present 12/28. Nodes are palpable, mobile, and non-tender.
51 2021-01-07 swelling face Facial swelling, shortness of breath, nasal stuffiness, tachycardia >150, IV solumedrol, Benadryl an... Read more
Facial swelling, shortness of breath, nasal stuffiness, tachycardia >150, IV solumedrol, Benadryl and Pepcid Relief in symptoms upon discharge at 2330
51 2021-01-08 lymph node swelling, swelling Swelling and pain of armpit, axillary lymph nodes, axillary breast tissue, under arm at axilla. Pain... Read more
Swelling and pain of armpit, axillary lymph nodes, axillary breast tissue, under arm at axilla. Pain and swelling of deltoid
51 2021-01-08 lymph node swelling Myalgia SOFT TISSUE SWELLING RIGHT AXILLA, SWOLLEN UPPER ARM; Narrative:
51 2021-01-09 lymph node swelling Severe migraine 24 hours after the second vaccine Very swollen lymph nodes in the arm pit of the arm... Read more
Severe migraine 24 hours after the second vaccine Very swollen lymph nodes in the arm pit of the arm that received vaccine
51 2021-01-09 lymph node swelling Lymph nodes along left neck swollen, soreness bilateral arm pits, and soreness at symphysis pubis ar... Read more
Lymph nodes along left neck swollen, soreness bilateral arm pits, and soreness at symphysis pubis area. General headache.
51 2021-01-10 lymph node swelling 36 hours of intense pain all over , fever , rigors, visible swelling of joints , swollen lymph node ... Read more
36 hours of intense pain all over , fever , rigors, visible swelling of joints , swollen lymph node in armpit of left arm
51 2021-01-10 peripheral swelling, axillary mass Shortness of breath Arm pain Lump under left arm pit Pain goes across chest and down arm No fever Ac... Read more
Shortness of breath Arm pain Lump under left arm pit Pain goes across chest and down arm No fever Achy all over Left arm down to fingers and up the arm and across the chest to swollen arm under arm pit is in pain
51 2021-01-10 swelling face Received dose 2hours post dose, itching throat, ears. facial swelling. Bendryl 50mg taken. Symptoms ... Read more
Received dose 2hours post dose, itching throat, ears. facial swelling. Bendryl 50mg taken. Symptoms continued for the day of shot and day after shot. Day 2 additional Bendryl total 200mg taken before relief of symptoms. My PCP is aware of reaction and will place allergy on chart.
51 2021-01-10 swelling Immunization received at 3pm no reaction immediately. Next morning I woke up with acne type lesions... Read more
Immunization received at 3pm no reaction immediately. Next morning I woke up with acne type lesions on my face and a large elongated swollen area on my back. My face cleared up but I had to go to the MD and have the back wound incision and drainage.
51 2021-01-11 anaphylactic reaction anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry... Read more
anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation. Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip. Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin, morphine and experienced drug hypersensitivity. The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-01-11 lymph node pain, lymph node swelling Swollen under the axial lymph node with pain
51 2021-01-11 lymph node swelling, lymph node pain Headaches, body aches, pain at injection site (left arm sore) and exhaustion. lymph nodes in left ... Read more
Headaches, body aches, pain at injection site (left arm sore) and exhaustion. lymph nodes in left armpit became swollen and painful to the touch starting on 1/8/21 until 1/11/21.
51 2021-01-11 lymph node swelling Developed pain, redness and swelling (injection site) about 8-9 hrs. after receiving the vaccine. Sy... Read more
Developed pain, redness and swelling (injection site) about 8-9 hrs. after receiving the vaccine. Symptoms increased day 2 with swelling as big as a lemon fruit. Day 3 - aside from pain & swelling at the injection site, I developed Left axillary lymphadenopathy. Day 4 - severe headache lip numbness & body ache Took Ibuprofen 400 mg each day
51 2021-01-11 lymph node swelling 10 hours later after received vaccine developed Left arm pain . During the night wake up due to seve... Read more
10 hours later after received vaccine developed Left arm pain . During the night wake up due to severe left axillary pain irradiated to left scapula, left breast, also has adenopathy, bone ache and fatigue. Taken acetaminophen
51 2021-01-11 swollen extremities Puffiness at wrist of same arm of injection, 2 and 1/2" L x 1 and 1/2" W. Also reporting shooting pa... Read more
Puffiness at wrist of same arm of injection, 2 and 1/2" L x 1 and 1/2" W. Also reporting shooting pain alternating down left arm, right leg, and across chest and head
51 2021-01-11 peripheral swelling Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness ... Read more
Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness all over; Neck is also really sore; head hurt/headache was in the occipital area; mild pain at the injection site; Her whole arm is swollen and sore/Sore upper arm/arm achy; Her whole arm is swollen and sore/Sore upper arm; whole arm felt warm/warm to the touch; This is a spontaneous report from a contactable Nurse(patient). A 51-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization(reported as for work). She worked in the hospital. She just got it at work. She didn't have a prescribing doctor. Her first dose was 3 weeks before today. Her first vaccine was a Pfizer vaccine with lot:13551. She got the 2nd dose 20 days later. She got the second dose on 05Jan2021. Medical history and concomitant medications reported as none. Also reported she did have other medical conditions, but she got the go ahead to get the vaccine from her rheumatologist. Patient received her second dose of vaccine 05Jan2021 and was experiencing fever, chills, achiness during the night last night on 06Jan2021. She was asking if she was experiencing adverse events or Sars-COV-2 symptoms. At first, she had mild pain at the injection site, but then in the middle of the night, her whole upper arm became sore and swollen. Not just at the injection site. Onset date of sore upper arm was 05Jan2021. She developed rigors/chills. She had achiness all over. She checked her temperature a half an hour to 45 min ago, and it was 99.9-100.2. She usually runs 96-97. It was around 3-4 am that she felt chilled, but not feverish. She was just chilled/ had rigors. It was a couple hours later at 7 am that she felt feverish. They were not high readings. In the past 10 minutes, her head had started to hurt. Her neck was also really sore. Her headache was in the occipital area. It had only been 10 mins that this had came on, and it was about the same. It really hurt. Onset date of headache/ neck pain was 06Jan2021. Her whole arm was swollen and sore. It was warm to the touch. Her whole arm felt warm and achy. She had used an ice pack, and it did help some. She was assuming this was just an expected immune response. She just didn't want to put anyone at risk. She was always very careful. She mostly worked from home, but she was in the office yesterday with two masks and a face shield. She also used a lot of spray and hand sanitizer. The outcome of events fever, achiness, "Her whole arm is swollen and sore/Sore upper arm/arm achy" and headache, neck pain was not recovered, of chills was recovered in Jan2021, of other events was unknown. Sore upper arm was reported as worsened.
51 2021-01-11 swelling face Fatigue; Dizziness, Light-headed; nausea; diarrhea; swelling of face; muscle pain; chills; joint pai... Read more
Fatigue; Dizziness, Light-headed; nausea; diarrhea; swelling of face; muscle pain; chills; joint pain; Overall feeling of unwell; This is a spontaneous report from a non-contactable other HCP (patient). A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EK5730, via an unspecified route of administration on 31Dec2020 at single dose on arm right for COVID-19 immunisation. Medical history included fibromyalgia and known allergies: Rose hip tea and Diclofenac. No COVID prior vaccination. No pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included zolpidem tartrate (AMBIEN) and duloxetine hydrochloride (CYMBALTA). The patient experienced fatigue, dizziness, light-headed, nausea, diarrhea, swelling of face, muscle pain, chills, joint pain, overall feeling of unwell; all on 01Jan2021. No treatment received for the events. Outcome of events was not recovered. Since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
51 2021-01-12 lymph node swelling No reaction immediately after receiving vaccine. Next day, 1/10/2021, noted left axillary pain, min... Read more
No reaction immediately after receiving vaccine. Next day, 1/10/2021, noted left axillary pain, minimal pain at left deltoid injection site. Used Tylenol for ineffective relief of discomfort. Next day, 1/11/21, noted swelling and pain along left collarbone area on chest/neck area. Called to speak with Dr. Told that I had left supraclavicular lymph node swelling causing discomfort, and still had swelling of left axillary lymph node causing discomfort. Also noted minimal left groin lymph node enlargement with no pain. Told to monitor symptoms and continue to use Tylenol or Advil as needed. Recommended that I call back if symptoms worsen, change or have additional symptoms.
51 2021-01-12 peripheral swelling Rec'd vaccine on 1/9/21. On 1/11/21 she developed swelling to both hands to the point it caused pain... Read more
Rec'd vaccine on 1/9/21. On 1/11/21 she developed swelling to both hands to the point it caused pain.
51 2021-01-13 lymph node swelling, swelling Swelling on left neck chest collarbone. Swollen lymph nodes. Redness pain. Only on left side. Left a... Read more
Swelling on left neck chest collarbone. Swollen lymph nodes. Redness pain. Only on left side. Left arm was injection site. Malaise. Have appt today 1/14/2021 at 230 at doctor's office.
51 2021-01-13 lymph node swelling Axillary lymphadenopathy with swelling extending to left breast. Left Scilla lymph node size of gol... Read more
Axillary lymphadenopathy with swelling extending to left breast. Left Scilla lymph node size of golf ball
51 2021-01-13 lymph node swelling Itchy tingling sensation in mouth and throat, hives on torso and spreading, itchy eyes and inside ea... Read more
Itchy tingling sensation in mouth and throat, hives on torso and spreading, itchy eyes and inside ears, swollen lymph nodes in neck and groin area
51 2021-01-13 lymph node swelling 1/2/2021 - Went for mammogram. Abnormal reading on left breast 1/8/2021- Follow up mammogram. Left b... Read more
1/2/2021 - Went for mammogram. Abnormal reading on left breast 1/8/2021- Follow up mammogram. Left breast dense tissue. Had ultrasound- lymph node under left armpit, 6mm. Will have ultrasound again in 6-8 weeks, Employee's MD stated that if the lymph node is reduces in size - then it is probably due to the covid shot.
51 2021-01-13 peripheral swelling Bone pain all over for 15 min and then to the lower legs, constant 12/23 1AM, at 0530 goes to ER , g... Read more
Bone pain all over for 15 min and then to the lower legs, constant 12/23 1AM, at 0530 goes to ER , given morphine, Valium,zofran, dexamethasone and norco and discharge home. No relief with med. lower feet noted trace of swelling, jaw pain and epigastric discomfort. Leg pain subside after 3 days but with muscular pain esp the upper arms. Extreme fatigue and mild tenderness on the back of head. It?s been 3 weeks now and I have the fatigue, epigastric discomfort, loss 10 lbs of wt. muscle easily get sore.
51 2021-01-13 peripheral swelling received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breath... Read more
received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breathing something similar to allergy season belreathing, and a slight headache on my rr temple. This was nothing that stopped me or slowed me down that day. At approx 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches. I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not. Friday, (12/25/20)was Christmas and much of the day was non eventful. At approx 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours. Saturday, (12/26) 4:am and I have notice much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopefully, all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night. I have a history of whooping cough. And gastric bypass.
51 2021-01-14 lymph node swelling On the 1/11/2021 I noted a discoloration to the outer left axilla area- resembling bruising, and a r... Read more
On the 1/11/2021 I noted a discoloration to the outer left axilla area- resembling bruising, and a round, flat rash like area. I have swelling to my left axilla, with 3 points of pain with palpation within it. I also have tenderness in my left breast closest to my axilla.
51 2021-01-14 swelling face Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling... Read more
Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling face/eyes Muscle pain - legs Muscle weakness - legs New onset hypertension Dizziness
51 2021-01-17 lymph node pain Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fati... Read more
Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fatigue, bilateral orbital pain. No visual problems. Took Tylenol every 4 hrs and fever (101. 5)returns in 1-2 hrs. Pulse ox remained normal, 98%, but pulse was 99/min. Usually my resting pulse ox is 55/minutes. Was unable to go to work and see patients. Had these symptoms for 48 hrs even though stayed in bed, took Tylenol around the clock and drank plenty of fluids (2-3 liters of water in addition to natural orange and apple juices). Never lost appetite either, do eating my vegetables and fish diet. Ice cream help between Tylenol?s. Completely resolved after 72 hrs. Now still have LEFT injection site tender deltoid and left axillary tender nodes, improving as well. All along breathing fine, no cough or congestion or sore throat. No anosmia or dysgeusia. This was after my second Pfizer dose. After the First dose only had tenderness on the RIGHT deltoid muscle injection site and tender axillary node, resolved by now.
51 2021-01-18 lymph node swelling 9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 we... Read more
9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.
51 2021-01-18 peripheral swelling, swelling face Systemic: Mild swelling on right side of the face and legs
51 2021-01-20 anaphylactic reaction Systemic: Anaphylaxis
51 2021-01-20 lymph node inflammation Lymphadenitis developed in my axilla and extended down my right chest wall.; This is a spontaneous r... Read more
Lymphadenitis developed in my axilla and extended down my right chest wall.; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration in the right arm on 08Jan2021 10:45 at a single dose for COVID-19 immunization. There were no medical history. The patient had no known allergies to medications, food, or other products. The patient was not pregnant. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 29Dec2020 at the age of 51 years old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced lymphadenitis developed in her axilla and extended down her right chest wall on 09Jan2021. No treatment was received for the adverse event. Outcome of the event was recovering. Information about batch/lot number has been requested.
51 2021-01-20 lymph node swelling, swelling face 12 days after 2nd vaccine-started with fever/chills, cervical lymphadenopathy and redness/vesicular ... Read more
12 days after 2nd vaccine-started with fever/chills, cervical lymphadenopathy and redness/vesicular type eruption on nose. Fever/chills persisted through night, followed by 16hr N/V and worsening of eruption- vesicular/pustular on nose, then with subsequent right facial swelling.
51 2021-01-21 neck mass I felt fine after the vaccine. Did just have a little soreness at the injection site. Then a co-work... Read more
I felt fine after the vaccine. Did just have a little soreness at the injection site. Then a co-worker told me my voice was strange, was hoarse. I was feeling fine. The next day I lost my sense of smell. Talked to my PCP and he told me to get tested for COVID, to my surprise I was positive. That was on the 28 or 29 of December. I also developed a lump on my neck on the right side and my PCP prescribed a Z Pack. I finished it but it never went away. I developed another lump on my left side when I took the second dose and I am taking Doxycicline for it.
51 2021-01-21 neck mass Chills, nausea, I felt feverish but did not take my temperature, I had sweats, headache, warm and at... Read more
Chills, nausea, I felt feverish but did not take my temperature, I had sweats, headache, warm and at the injection site it swollen and red happened in the middle of the night. For the next 2 days I had extreme fatigue and after that I was fine (by Sunday). I did not have any energy but no chills or nothing. I took Tylenol and it helped me. I was able to return to work on Monday and as the day passed I started feeling like myself. I also developed a lump on my neck on 01/18/2021 on the left side (on my collarbone) and my PCP prescribed Doxycycline 2 tablets a day. I also developed a lump on my right side when I took the first dose and took a ZPack and that lump is still here on my neck.
51 2021-01-21 swelling face Minor Face and Throat swelling. Irregular eye lid movement. Lips num and felt twisted.
51 2021-01-23 lymph node swelling By 10pm on 1/23/21, I was experiencing chills, fatigue, and swollen lymph node in my right armpit a... Read more
By 10pm on 1/23/21, I was experiencing chills, fatigue, and swollen lymph node in my right armpit as well as soreness at the injection site (which started hours earlier). On 1/24/20, chills and extreme fatigue continued along with dull headache, lack of appetite, and general feeling of unwellness. Temperature at 3:30pm was 101.2F.
51 2021-01-25 lymph node pain, lymph node swelling diagnosed with Covid-19 after the 1st dose; diagnosed with Covid-19 after the 1st dose; Pneumonia; F... Read more
diagnosed with Covid-19 after the 1st dose; diagnosed with Covid-19 after the 1st dose; Pneumonia; Fever; Body aches; swollen lymph nodes under left armpit; Exposed to COVID; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that a 51-year-old female patient received the first does of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 08:30 in left arm at single dose for covid-19 immunization. The patient medical history was none. Family medical history was no. Patient had been taking vitamin supplements. No vaccinations were taken within 4 weeks. Patient received first COVID-19 Vaccine on 21Dec2020 around 08:30. Between that three weeks period, patient was diagnosed with COVID. Patient was exposed the following weekend. Took four tests to finally test positive within a four-day-span. Patient was exposed to COVID on 26Dec2020. On 28Dec2020, patient experienced swollen lymph nodes under left armpit. Progressively got more sensitive on 29Dec2020. Patient thought maybe it was a side effect of the COVID-19 Vaccine. Wednesday morning, 30Dec2020, around 10:00 patient noticed body aches. Around 12:00 patient noticed a fever. On 30Dec2020, patient had a 24-hour lab test to check for COVID. All other COVID tests performed were rapid tests. First COVID test was on 30Dec2020. Patient had another COVID test on 31Dec2020, and two COVID tests on 02Jan2021. Patient was tested positive for COVID on 02Jan2021. COVID test that resulted positive was a rapid test in the emergency room. Patient was diagnosed with Covid-19 after the 1st dose. Patient was in the emergency room with pneumonia which occurred on 02Jan2021. It was confirmed patient was discharged from the emergency room six to seven hours after arrival. Lot number from patient card was either EJ1685 or ET1685. Caller unable to confirm lot number from patient card. Chest X-ray was what sent her to emergency room labs and blood work done on 02Jan2021 in emergency room. Labs were done in clinic a couple days before flu and strep test both negative on an unspecified date. Patient didn't remember all tests and results. Outcome of all events were unknown. Caller would like to know whether she should take the 2nd dose or not. Information on the lot/batch number has been requested.
51 2021-01-26 peripheral swelling, swelling face Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, d... Read more
Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, difficulty breathing, swollen face, rash on the neck , torso and arms, itchiness of the eyes, chills . Took some benadryl, cream and pills. Next day malaise, swollen hands, body aches.
51 2021-01-27 lymph node swelling after received the pfizer vaccine. Within a day, I have a swollen Lymph Nodes on the side of the arm... Read more
after received the pfizer vaccine. Within a day, I have a swollen Lymph Nodes on the side of the arms that Vaccine was injected. It hurts when close left arm to my body.
51 2021-01-27 swelling rash on chest and upper back; sore throat; muscle twitching around left eye; Fatigue; headache; musc... Read more
rash on chest and upper back; sore throat; muscle twitching around left eye; Fatigue; headache; muscle aches; swelling on left side of body including facial, arm pit, and arm down toward elbow, upper back under shoulder blade; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284, expiration date unspecified), intramuscular on 12Jan2021, at 13:00 at single dose (left arm) for COVID-19 immunization. Medical history included Covid-19 (prior vaccination). The patient was not pregnant and had no known allergies. Concomitant medication included acetylsalicylic acid (ASPIRIN). On 12Jan2021, at 15:00, the patient experienced fatigue, headache, muscle aches, swelling on left side of body including facial, arm pit, and arm down toward elbow, and upper back under shoulder blade, rash on chest and upper back, sore throat, and muscle twitching around left eye. The patient had no treatment for the events. The patient had no other vaccine in 4 weeks; and patient was not Covid tested post vaccination. Outcome of the events was not recovered.
51 2021-01-28 swelling Angioedema within 5 minutes, epinephrine 0.3mg IM given at clinic site, transferred to emergency roo... Read more
Angioedema within 5 minutes, epinephrine 0.3mg IM given at clinic site, transferred to emergency room, given famotidine and diphenhydramine, methylprednisolone inj @ 1333. angioedemia resolved within 30 minutes from interventions.
51 2021-01-28 lymph node swelling severe headache and fatigue began about 3 p.m. on 1/21/21 (the day after vaccine administered). I w... Read more
severe headache and fatigue began about 3 p.m. on 1/21/21 (the day after vaccine administered). I went to bed early and slept later than usual and after about 9 1/2 hours of sleep, the headache and fatigue were only very minimal. On 1/22/21 when I woke up I had an enlarged lymph node under my arm about 2 inches in diameter. The lymph node was enlarged until 1/27/21
51 2021-01-28 lymph node swelling cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble... Read more
cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble finding words; extreme fatigue; nausea; achiness at joints; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL0140, expiry date unknown), via an unspecified route of administration (vaccine location: left arm), on 23Dec2020 17:00, at single dose, for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes - all on 24Dec2020. These symptoms never left up until day 21 when the patient received her next shot. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination, and had not been Covid-tested post vaccination. It was unknown if treatment was received for the adverse events. The patient was recovering from the events.
51 2021-01-28 lymph node swelling Started with body aches about 14 hours after injection progress to severe joint and bone aches espec... Read more
Started with body aches about 14 hours after injection progress to severe joint and bone aches especially in hands and feet . Stabbing random headaches , fever 101, chills, sweating these symptoms lasted about 24 hours . Then about about 36 hours I woke up in the morning with swollen lymph nodes under left arm very painful. All other symptoms have gone but swollen lymph nodes are persisting current time since dose is about 48hrs.
51 2021-01-28 swelling face Given 2nd dose of Covid vaccine on 1/9/21 and felt immediate jolt of pain in left shoulder and scapu... Read more
Given 2nd dose of Covid vaccine on 1/9/21 and felt immediate jolt of pain in left shoulder and scapula region and complained of not feeling well. Per ED note, mild facial swelling, no evidence of any other symptoms, given Benadryl, Steroids and Pepcid, monitored for 4 hours and discharged.
51 2021-01-31 peripheral swelling 1st shot on 1/5/2021 felt really tired and fatigued. Woke up at 5:30am on 1/6/2021 with chills and ... Read more
1st shot on 1/5/2021 felt really tired and fatigued. Woke up at 5:30am on 1/6/2021 with chills and a headache. Some light swelling and soreness at the injection site on the left arm. 2nd shot on 1/26/21 @ 4:15pm. Right arm swollen, muscle very sore and tight feeling. Some bruising. Half dollar sized knot at the inject site.
51 2021-02-02 peripheral swelling **Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze de... Read more
**Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze deviation at midnight and admitted to hospital (last seen normal around 7 pm 1/24/2021). Intubated in ED, ABG 6.98/17/186 on 40%, Bicarb <5, Scr 1.4, Lactate 1, Wbc 20.3, BP 101/45-- >95/41, Temp 94.3, RR 23-32. Acidotic and initially required norepineprine for hypotension management (stopped 1/26/2021 0400 am) 1/26 to 2/1/2021 - supportive care for encephalopathy (anoxic vs. ischemic brain injury), ARF, HTN, MSSA growth in resp culture (no respiratory distress, on antibiotic) 1/28 GCS:E4VTM4; 1/29 GCS: EV4VTM4 with intact protective reflexes, extubated 2 pm 2/1 arousable, follows very simple commands, non verbal
51 2021-02-03 peripheral swelling This employee sent me an email on 12/23/20. "Subject: Re: Attention Covid Vaccine Volunteers Hell... Read more
This employee sent me an email on 12/23/20. "Subject: Re: Attention Covid Vaccine Volunteers Hello, I had received my vaccine earlier today and just awoken to chest pains. I do not think it wise to be there for my shift in the next 8 hrs. I will stay and observe for additional symptoms. I was on vacay and had out-of-office notice set for my email. I discovered this email yesterday while catching up on emails. I immediately called her. She described the details of the events; stated she has not sought medical care; all symptoms resolved spontaneously but still has some intermittent, mild SOB> She sent me this email describing the reaction: Here explanation of the reaction: Thank you for the follow up. Below is a list of symptoms I experienced after I received my initial dose of the Pfizer vaccine. I am scheduled to receive my 2nd dose next week on the 13th of January. following up: I received my shot at 8:15 am, within approximately 45 min I felt a very slight heaviness to my breathing something similar to allergy season breathing, and a slight headache on my rt temple. This was nothing that stopped me or slowed me down that day. At ~ 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches. I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not. Friday, (12/25/20)was Christmas and much of the day was non eventful. At ~ 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours. Saturday, (12/26) 4:am and I noticed much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopeful that all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night." I advised she contact her PCP to determine if follow up is indicated given persistent, intermittent cough and SOB.
51 2021-02-03 swelling face She got her first vaccine o 12/30/20 and by 1/5 started noticing some swelling and numbness in her f... Read more
She got her first vaccine o 12/30/20 and by 1/5 started noticing some swelling and numbness in her face, it has slowly gotten worse and now has a drooping eye, worsening facial numbness and droop.
51 2021-02-04 lymph node swelling Fever at max 39.7, body aches, chills, headache, nausea Severe lymph node swelling armpit on the sid... Read more
Fever at max 39.7, body aches, chills, headache, nausea Severe lymph node swelling armpit on the side of injection ( size of a ping pong ball)
51 2021-02-04 lymph node swelling Around 7 p.m. patient felt chest weakness & minor SOB. Took Ibuprofen 400 mg PO. Woke up in middle o... Read more
Around 7 p.m. patient felt chest weakness & minor SOB. Took Ibuprofen 400 mg PO. Woke up in middle of the night, had increased SOB and chest weakness. Describes as felling "Not well." Drank water. Felt better. Went back to sleep. 2/4: Patient c/o nasal congestion, slight blurred vision, increased SOB/chest weakness, had body aches, slight swelling in neck lymph node (hx of swelling due to abscess). Felt better as day progressed but in afternoon @ 3:30 p.m. while at store with family, had to leave to sit in car due to fatigue and reoccurring SOB. Minor SOB episode throughout the day. Slept well at night. Took Ibuprofen 400 mg PO x1 which improved body ache.
51 2021-02-04 lymph node swelling 02/02/2021 at 11:30am breathing uneasy; I took Benadryl at home and slept for 10 hours. Pain to inj... Read more
02/02/2021 at 11:30am breathing uneasy; I took Benadryl at home and slept for 10 hours. Pain to injection site upon waking; I took Tylenol 8 hrs and drank 20 oz water. 02/03/2021 at 130am running nose and nausea started. At 9am I took some alka seltzer cold tabs. At 5pm I realized pain to right arm was worsening after full inspection I recognize swollen axillary lymph nodes; entire arm pit is swollen. I applied moist heat compress throughout the night and took more Tylenol. I hydrated with water and just layed around resting my body. 02/04/20 swelling continues with some decreased visible; pain to right arm pit continues and nausea continues.
51 2021-02-05 lymph node swelling Low grade fever and underarm swelling/soreness Fever lasted around 6 hours
51 2021-02-06 pancreatitis Stomach pain, stomach swelling and nausea off and on. Started on Tuesday morning. Went to the Emerge... Read more
Stomach pain, stomach swelling and nausea off and on. Started on Tuesday morning. Went to the Emergency Room on Friday afternoon and was diagnosed with Pancreatitis. Sent home with pain and anti-nausea meds.
51 2021-02-07 lymph node swelling Rt. arm rash, itching at the injection site. Pain and swelling under armpit and rt. chest area on r... Read more
Rt. arm rash, itching at the injection site. Pain and swelling under armpit and rt. chest area on rt. side (injection side), no treatment given at this time, Pain continues will see MD. Pain noted under armpit when lying on that side. Visible swelling of armpit and rt. chest area present.
51 2021-02-07 peripheral swelling Swelling and very painful arm. The size of a grapefruit. Fever, headache, weakness and body aches
51 2021-02-07 swelling Sore arm at the site of injection. Extreme pain and swelling in big right toe. Toe also felt hot to ... Read more
Sore arm at the site of injection. Extreme pain and swelling in big right toe. Toe also felt hot to the touch. I iced both locations and ultimately took 2 200mg Advil tablets. Arm is still tender the second day. The toe felt fine all day then at 5:30pm it started to feel like it was swelling again. I immediately took 2 200mg of Advil.
51 2021-02-08 lymph node swelling, swollen extremities Developed ache in arm of injection-site - but NOT at the site itself - rather all around it from elb... Read more
Developed ache in arm of injection-site - but NOT at the site itself - rather all around it from elbow to neck to scapula. Started about 12hours after injection (woke me at 4:00am). Then over the next several hours developed fever up to 101.5, ibuprofen reduced only to 100.4. This cycle continued through the following day, when temp peaked at 102.2 around 48hr post-injection. Added Tylenol to the ibuprofen, temp then decreased to 100.4. Woke the third day with un-medicated temp between 99-100 all day, but L axillary lymph nodes now swollen. Spent all 3 days on couch, resting and pushing fluids. No GI symptoms at all. Day 4 - Temp normal, but slightly dizzy. Pain and some edema from elbow to scapula to neck continued throughout and still continues now. Axillary lymph nodes still swollen and sore. Some nasal congestion, still a bit dizzy. Never had any pain (just tender to touch) at the actual injection site. Also, I never had any symptoms at all with the first injection. I see nowhere else to put this - I received the injection at my workplace.
51 2021-02-08 swelling Patient received the Pfizer Covid vaccine number 2 and about 15 minutes after the dose began itching... Read more
Patient received the Pfizer Covid vaccine number 2 and about 15 minutes after the dose began itching and showing some raised red hives on arms and scalp and a little on the back. we administered Benedryl 50mg IM and within about 10 minutes itching decreased and no additional symptoms have arrisen
51 2021-02-09 lymph node swelling Nausea; vomiting; body aches; chills; constipation; cramping; swollen lymph nodes in neck and under ... Read more
Nausea; vomiting; body aches; chills; constipation; cramping; swollen lymph nodes in neck and under arms; This is a spontaneous report from a contactable healthcare professional (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), intramuscular in the left arm on 22Jan2021 09:30 at a single dose for COVID-19 immunization. The patient's medical history included allergies to IV dye. The patient was not pregnant at the time of vaccination. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular in the left arm on 31Dec2020 09:30 at the age of 51 years old for COVID-19 immunization and codeine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 22Jan2021 10:00, the patient experienced nausea, vomiting, body aches, chills, constipation, cramping, swollen lymph nodes in neck and under arms. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
51 2021-02-09 swelling, lymph node swelling, neck mass Swelling in the area at the base of the neck on the left shoulder; swelling in the area at the base ... Read more
Swelling in the area at the base of the neck on the left shoulder; swelling in the area at the base of the neck on the left shoulder, (there was a small lump in that area); Soreness/tenderness in the area near the collarbone; Soreness/tenderness in the area near the collarbone; Pain in the left armpit; Swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELI283 and expiry date: unknown), via an unspecified route of administration on the left arm, on 18Jan2021 12:15 at single dose for covid-19 immunisation. Medical history included high blood pressure and seasonal allergies. Patient was not pregnant at the time of vaccination. Concomitant medication included losartan potassium, naproxen sodium (ALEVE) and unspecified OTC allergy medications. There were no other vaccines received within 4 weeks prior to COVID vaccination. The patient experienced pain in the left armpit and swollen lymph node on 23Jan2021 11:30. On 24Jan2021 17:00, patient experienced swelling in the area at the base of the neck on the left shoulder, (there was a small lump in that area) and soreness/tenderness in the area near the collarbone. Patient had not recovered from the events and had not received any treatment. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
51 2021-02-10 lymph node pain 2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch... Read more
2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch throat; body aches; dizziness; headache; lymp nodes tender; eye swelling; blurred vision; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; tooth pain; jaw pain; i also had leg and bilateral foot pain x 4 days; all my mucos membranes were red, irritated and blistered; all my mucos membranes were red, irritated and blistered; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 19Jan2021 10:45 at a single dose on left arm for COVID-19 immunization. Medical history included allergies: sulfa. Concomitant medication included bupropion (BUPROPION). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced 2 hrs after 2nd injection, 'felt like I was burning from inside out', Skin red, flushed, rash, scratch throat, temp, body aches, dizziness, headache, lymph nodes tender, eye swelling, blurred vision, 'blisters on the trunk of my body as well as lips and gums', tooth pain, jaw pain. All of these symptoms lasted 3 days (as reported), blisters and gum issues lasted 4 days (as reported). Patient also had leg and bilateral foot pain x 4 days. All mucous membranes were red, irritated and blistered. The adverse events were experienced on 19Jan2021 12:30. Therapeutic measures were taken as a result of the events which included Benadryl, steroid injection. The outcome of the events was recovering (as reported). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-02-10 peripheral swelling LT Arm Pain and swelling of arm and Lt hand , treated with hot and cold packs and pain relievers, s... Read more
LT Arm Pain and swelling of arm and Lt hand , treated with hot and cold packs and pain relievers, still have pain and swelling 5 weeks after shot
51 2021-02-11 swelling Swollen/ tender collar bone and area. Neck pain all on right side along with knot that maybe lymph n... Read more
Swollen/ tender collar bone and area. Neck pain all on right side along with knot that maybe lymph node swelling.
51 2021-02-14 anaphylactic reaction, swelling face Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Other- Anxiety/Panic-Medium
51 2021-02-14 lymph node swelling enlarged lymph node r axilla, no rash, no face/mouth swelling, afebrile, no swelling of extremity
51 2021-02-14 swelling Interaction with derma-fillers- no medical attention needed. Ice applied to the sore -mildly swollen... Read more
Interaction with derma-fillers- no medical attention needed. Ice applied to the sore -mildly swollen areas. Soreness subsided within 48 hours of onset.
51 2021-02-14 white blood cell count increased, swollen extremities Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up t... Read more
Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up to ankles, later rising up to her knees. Pt admitted to hospital on 2/6/21 for symptomatic anemia 2/2 vaginal bleeding. Patient received 4 units FFP, 4 units PRBC, 1 unit cryoprecipitate, and vitamin K 5 mg IV. Also started on medroxyprogesterone 20 mg PO TID. Alectinib d/ced due to worsening liver function. Evalauted by OB/GYN and Hematology. Diagnosed with DIC. Patient with worsening bilateral lower extremity edema and purpura with pain and weakness. Palliative care consulted. Patient passed away on 2/11.
51 2021-02-15 peripheral swelling At arm pain at 11:00 pm. The following day, my left arm swelled up from wrist to shoulder - three ti... Read more
At arm pain at 11:00 pm. The following day, my left arm swelled up from wrist to shoulder - three times it's size. I couldn't move my arm for 24 hours. Arm pain was gone after 24 hours. Two days after - I was freezing cold, on the couch. Following day, I called my doctor. He told me to rest. I had a high fever and I had body aches. I was really cold. I felt like I had the flu for about a week - missed a couple days of work.
51 2021-02-16 peripheral swelling, lymph node swelling General soreness at the injection site for 48 hours. 4 days later left arm (injection) swelling of ... Read more
General soreness at the injection site for 48 hours. 4 days later left arm (injection) swelling of armpit lymph node. And later entire arm. Very painful, tender, sore and with restricted movement. Home medical visit Sat and Monday with Doctor. Ice/heat, liquids, Ibuprofen compression sleeve and elevation
51 2021-02-17 swelling, lymph node swelling Symptoms have not gone away. I still have (on and off) the back of my left shoulder up my neck into... Read more
Symptoms have not gone away. I still have (on and off) the back of my left shoulder up my neck into my jaw is where it's hurting. This usually comes with a migraine, but I don't have one today. It's just odd because I've never had this before, all the symptoms all at once. I've noticed under my left arm pit on occasions, sometimes when I'm laying at night feel swollen and in my groan as well. I have had some weird symptoms. I do get chills of and on but not at this very moment. My left ear has became hurting where the jaw pain is. I have to have my ears cleaned every so after so not sure if that has to do with my pain going on. I saw the ENT on December 30 and going to see them again on February 24th.
51 2021-02-19 axillary mass Large lump in the left armpit area with pain to the touch. In the vaccine administration area, it is... Read more
Large lump in the left armpit area with pain to the touch. In the vaccine administration area, it is hot and very itchy to this day.
51 2021-02-21 lymph node swelling The day after felt very fluish. Very fatigued and had swollen lymph node above right collar bone.
51 2021-02-21 lymph node swelling On day 5 after receiving the vaccine I developed swollen lymphnodes under my left armpit and above m... Read more
On day 5 after receiving the vaccine I developed swollen lymphnodes under my left armpit and above my left clavical bone. My neck felt and under my chin felt sore and tender. It is day 9 and I still have the swollen nodes, soreness and tender feeling in neck, shoulder and chin.
51 2021-02-21 lymph node swelling Enlarged lymph nodes on left and right side of armpits and both breasts. The left side enlargement ... Read more
Enlarged lymph nodes on left and right side of armpits and both breasts. The left side enlargement was very visible to the naked eye and looked to be as large as a tennis ball. Both breasts where swollen and tender/sore. Right side enlargement of armpit as not as large (maybe the size of a golf ball).
51 2021-02-21 peripheral swelling Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. Th... Read more
Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. They asked me what are my allergies and medical history. I couldn't remember - so had brain fog at that time. My left ear, face, and neck (left side of head) is numb at that time. The symptoms were the same for two hours. Memory remained fogged. An hour or so after the incident - I called the advice nurse from medical clinic and I did remember the doctor's name. Pain on head and numbness remained for days. My auto-immune system was stimulated my doctor said. Everything kept cascading down - now I'm on post surgery 9 days and I'm on disability. I went to ER on January 18, I was complaining of left sided numbness, vomiting, headaches. Facial numbness (left), mild headaches. Left sided headache progressed to (similar to prior migraine headaches) migraine like. January 29, I emailed my physicians (in between the 17th and 29th). On the 29th, I went to see the doctor - joints - really swollen and painful and I cannot walk. I was given steroid shots. February 2, - appt with neurologist. February - with Dr. - for painful swollen feet; Feb 10 - appt with Rheumotologist - Feb 10 with Dr - a Specialist - , as well. Right foot is swollen as well as the left foot at this time. Dr. - axperatated the right ankle -he said it was infected. February 11, Dr said I have infected joints and need surgery. They did surgery on February 13th. Dr. the surgeon . Had surgery at medical facility for infected ankle. February 15 - discharged home. Appt with surgeon on the 16th. Appt with Primary on the 19th. Appt with my Rheumotologist today. Discharged - with Home Health care; Physical and Occupational therapist and nursing. I have been on bedrest since discharge. I need maximum care. Tomorrow I have a appt with surgeon to hopefully remove cast and sutures on surgical site.
51 2021-02-23 lymph node swelling Developed shingles. One day after vaccine: fatigue, intermittent headache on one side of head, achy ... Read more
Developed shingles. One day after vaccine: fatigue, intermittent headache on one side of head, achy body, tingling sensitive scalp, stiff neck. Two days after vaccine: rash and swollen lymph nodes behind and in front of ear, in a line down neck, and at collarbone. Rash on one side of body only, in a band from the back of neck, across ear, down side of jaw and neck to collarbone. Slight pain and sensitivity in entire arm where I received the vaccine, which is the same side of body as rash. Three days after vaccine: rash continues, some blisters erupt. Four days after vaccine: rash is worse, tingling and burning, painful welts;visited clinic and diagnosed with shingles and prescribed topical medications.
51 2021-02-24 swelling face, peripheral swelling 1/4 vaccination Within 24 hours, right away the area of injection site was swollen, hard, grew to th... Read more
1/4 vaccination Within 24 hours, right away the area of injection site was swollen, hard, grew to the size of my hand. The following day, I started getting hives, SOB, and my sinus swelled up, face and extremities. I took Benadryl and went to Urgent Care. Urgent Care put me on medication; vertigo, allergic reaction and sinus infection. Start taking Famotidine, Hydroxyzine-pamoate, prednisone. Followed up with PCM; benadryl Sinuses are still swollen, facial parts still swollen. Going to follow up with PCM I take a nebulizer. That medicine, the albuterol, inhaler Prevail.
51 2021-02-25 peripheral swelling At the vaccine administration location, patient experienced the following symptoms: tightness in che... Read more
At the vaccine administration location, patient experienced the following symptoms: tightness in chest, tightness in throat, nausea, ithcy tingley lips, burning lips, bumps/gives on inside of lips. Patient given diphenhydramine 25 mg oral solution PO x1. Vitals taken: WNL. Patient denied EMS transport to ER and transported self to ER. Per ED Provider Notes: Patient reports vaccine was given about 1.5 hours prior to arrival. Pt reported sensation of swelling of her arms, left eye itchiness, and itchiness on the inside of her lips. She denied any difficult, no abnormal sensation in her throat, throat swelling or swelling elsewhere in her mouth. Pruritus documented, no rash. Nausea. At the time of the ER provider examining patient. it is reported that patient was not having anaphylaxis but does have a flat appearing raised lesions on side aspect of upper lower lip. Pt treated with IV diphenhydramine, PO Prednisone and IV famotidine along with NS. Patient observed for 2.5 hours and then discharged. No swelling, itching or swelling and time of discharge and reports resolution of symptoms.
51 2021-02-25 swelling face About 15 min after administration, patient started c/o numbness/tingling in chin and lips. Patient w... Read more
About 15 min after administration, patient started c/o numbness/tingling in chin and lips. Patient was given oral diphenhydramine 50mg and notified EMS. When EMS arrived about 15 min later, patient initially declined to go to ER for eval. About another 15 min later, patient returned to clinic as face and chin were starting to swell slightly. Re-notifed EMS and the returned and picked up the patient. Patient left in awake condition, no respiratory distress.
51 2021-02-26 peripheral swelling Patient had immediate swelling to left hand (vaccine received in left arm). Bilateral grip strength ... Read more
Patient had immediate swelling to left hand (vaccine received in left arm). Bilateral grip strength equal, pulses equal bilaterally, ROM equal bilaterally. Patient is obese so it was difficult to detect swelling but her spouse stated her left hand "looked a little swollen." She was assessed by paramedics and given Benadryl 25 mg.
51 2021-02-27 lymph node pain, lymph node swelling Elevated blood sugar levels beginning 6 hours after injection; Diarrhea multiple times 5 hours after... Read more
Elevated blood sugar levels beginning 6 hours after injection; Diarrhea multiple times 5 hours after injection; Fever of up to 102.5 starting 12 hrs after injection; Chills and shaking starting 12 hrs after injection; Very swollen and tender lymph node above clavicle noticed approximately 42 hours after injection; Muscle and joint pain
51 2021-02-28 swelling, lymph node swelling I started having swelling, armpit got swollen (lymph nodes), top clavicle got really large and under... Read more
I started having swelling, armpit got swollen (lymph nodes), top clavicle got really large and under neck lymph nodes got swollen. I'm still exp swelling top clavicle lasting 2 months. I did see my PCP was told it was inflammatory response.
51 2021-03-01 anaphylactic reaction Swollen lips, mild anaphylaxis, hives all started 60 minutes after vaccination. We traveled from our... Read more
Swollen lips, mild anaphylaxis, hives all started 60 minutes after vaccination. We traveled from our home (approx 2 hr drive) & were on road. My husband is a physician & when we noticed symptoms administered Benadryl, Claritin, & famatodine.
51 2021-03-01 lymph node swelling Thickening of lymph node in left axillary.
51 2021-03-02 lymph node swelling, peripheral swelling, lymph node pain patient had pain in the arm that she received the vaccine; patient had pain in the arm that she rece... Read more
patient had pain in the arm that she received the vaccine; patient had pain in the arm that she received the vaccine. It was also a little swollen; the lymph nodes under that same arm was really swollen and there was some pain and discomfort along with it; the lymph nodes under that same arm was really swollen and there was some pain and discomfort along with it; This is a spontaneous report from a contactable other health professional (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9262, via an unspecified route of administration in the left arm, on an unspecified date at SINGLE DOSE for covid-19 immunization. Medical history included covid-19 diagnosed prior vaccination. Concomitant medication included spironolactone, linaclotide (LINZESS), paracetamol (TYLENOL) and caffeine, paracetamol (EXCEDRIN). On 30Jan2021, 20:45, the patient had pain in the arm that she received the vaccine. It was also a little swollen. As well as the lymph nodes under that same arm was really swollen and there was some pain and discomfort along with it. Outcome of events was not recovered. Patient did not receive treatment due to the events. Follow-up attempts are completed. The following information on the batch number has been obtained.
51 2021-03-02 lymph node swelling The lymph nodes on the left side of my neck are extremely sore. It feels tight and painful to move ... Read more
The lymph nodes on the left side of my neck are extremely sore. It feels tight and painful to move or sleep.
51 2021-03-03 peripheral swelling Numbness in fingers and hands, arms, legs, and feet. Right leg swollen. Knee 3 times the regular siz... Read more
Numbness in fingers and hands, arms, legs, and feet. Right leg swollen. Knee 3 times the regular size. Throbbing in feet and swollen, stiffness can't hardly bend right knee. Made my neuropathy worse. Head aches more, blurry vision, light sensitive, body aches, backache, coughing.
51 2021-03-04 lymph node swelling Headaches, underarm glands swollen, body aches, soreness, redness of arm, fever near area
51 2021-03-04 lymph node swelling Developed phantosmia immediately following shot 1. I smelled cigarette smoke 24 hours a day. It got ... Read more
Developed phantosmia immediately following shot 1. I smelled cigarette smoke 24 hours a day. It got slightly better then the phantosmia got worse. I have been smelling smoke for 53 days now. I also developed 2 large nodes in my left clavicle area. Same side as shots. I had to have an ultrasound and 1 was suspicious so now have to have an MRI. I have been to an ENT and my PCP who feel this was caused by the vaccine.
51 2021-03-05 lymph node swelling swollen lymph nodes under right arm week after first injection did not get better second injection... Read more
swollen lymph nodes under right arm week after first injection did not get better second injection was given in left arm a week after swollen lymph nodes underarm left arm now two weeks out have swollen lymph nodes everywhere neck behind ears back groin inner thighs
51 2021-03-07 peripheral swelling Right arm swollen. Pain in joints and muscle tissue. Headache and nausea. Inability to work or be pr... Read more
Right arm swollen. Pain in joints and muscle tissue. Headache and nausea. Inability to work or be productive for 5 days.
51 2021-03-07 swelling 02/20/2021-COVID vaccine injected high into the upper shoulder causing redness/soreness immediately ... Read more
02/20/2021-COVID vaccine injected high into the upper shoulder causing redness/soreness immediately at the site, ct felt neck swell 'like a balloon', monitored x 30 min, RNs at clinic determined not an anaphylactic reaction. PHN at site recommended after 24hrs to take antinflammatory and warm pack on site. Neck sensation continued x couple of days, referred to PCP for evaluation.
51 2021-03-08 lymph node swelling Dose was given at 2:20pm. On March 6th By 10pm tiredness began Slept for 11 hours Woke up on the 7th... Read more
Dose was given at 2:20pm. On March 6th By 10pm tiredness began Slept for 11 hours Woke up on the 7th with chills which lasted on and off as doses of tylenol wore off Muscle aches in arms and legs all day. Slept throughout the day feeling as if I could not get fully awake. By 10pm on the 7th,the night after the shot, I was back in bed. Woke up on the 8th feeling rested, no more body aches or chills....but a lump had appeared over night in my left armpit...i assume a swollen lymph node as it is on the side of the injection. Today is the 9th and the lymph node is still swollen.
51 2021-03-08 oral herpes Initial 48 hour period showed little to no reaction. Then chills and fever of 101 followed by more ... Read more
Initial 48 hour period showed little to no reaction. Then chills and fever of 101 followed by more chills and low grade fluctuating fever going on over 48 hours. The unusual event is that this reaction occurred 8 days after vaccination beginning on 3/7/21. Has not resolved completely yet as of 3/9/21. Because of the delay, I took a covid19 pcr test which was negative.
51 2021-03-09 lymph node pain, lymph node swelling The next day after I received the Covid 19 vaccine, my lymph node under my left arm ( the arm in whi... Read more
The next day after I received the Covid 19 vaccine, my lymph node under my left arm ( the arm in which I received the vaccine ) swelled to about the size of a softball, and was very tender for 3-4 days in duration.
51 2021-03-09 swelling face I had bad hives allergy reacción and swollen face ,
51 2021-03-09 swelling Saturday, day of shot, symptoms began with being tired about 4 hours after the shot and started with... Read more
Saturday, day of shot, symptoms began with being tired about 4 hours after the shot and started with being tired then led to extreme exhaustion and lethargy and loss of taste (salty and sweet), but had an appetite and drank a LOT of water, taking Tylenol around 6 pm; slept restless and in pain with fever and feeling both burning up and freezing cold with clammy chills. Couldn't settle. Approximately 3:30 am, had diarrhea until I had nothing in my system and developed uncontrollable shaking. Finally got some sleep after a hot bath. The next day, no appetite, drank little water and kombucha to settle my stomach, exhausted, feverish, napped off and on all day, right arm began hurting tremendously and right side including jaw and tongue felt swollen, took Tylenol in the morning and BC Powder pm before bed. Slept moderately well. Monday, napped off and on but started feeling better with only moderate exhaustion around 6 pm, but right arm was in pain. Tuesday, moderate exhaustion, had to nap for 2 hours mid-day, right side of body including tongue was swollen, arm in pain and entire upper arm muscle felt knotted. Went for a massage and worked out knot quite painfully. Today, moderate to mild exhaustion, upper right arm a bit sore, semi- decent appetite.
51 2021-03-11 lymph node swelling My left arm where the shot was administered, my underarm developed a huge swollen lymph node that la... Read more
My left arm where the shot was administered, my underarm developed a huge swollen lymph node that lasted for about 4 days before the swelling went down.
51 2021-03-11 lymph node swelling approx 18 hours after vaccine admin: chills, tiredness and body aches - rest, alternating ibuprofen,... Read more
approx 18 hours after vaccine admin: chills, tiredness and body aches - rest, alternating ibuprofen, tylenol - a nap resolved the tiredness, medication did not help the body aches or chills; symptoms resolved by approx 28 hours after admin; approx 48 hours after admin, swelling of lymph nodes in right armpit - tried ice, ibuprofen - did not resolve the condition or discomfort, however, heat has helped the discomfort, has not resolved as of 65 hours post vaccination
51 2021-03-14 bursitis, lymph node pain Loss of appetite, fatigue, nausea, fluid collection in elbow, tender lymph nodes in left side neck.
51 2021-03-14 lymph node swelling swollen lymph node under left arm causing pain; swollen lymph node under left arm causing pain; This... Read more
swollen lymph node under left arm causing pain; swollen lymph node under left arm causing pain; This is a spontaneous report from a contactable consumer reported for herself that a 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 51-years via an unspecified route of administration in left arm on 24Feb2021 at single dose for COVID-19 immunization. Medical history included high blood pressure; fibromyalgia; kidney stones. Patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included paracetamol (TYLENOL ARTHRITIS); enalapril; amlodipine; hydrochl (as reported). The patient historically received first single dose of BNT162B2 at the age of 51-years via an unspecified route of administration in left arm on 03Feb2021 03:00 PM for COVID-19 immunization. On 26Feb2021 06:00 AM, the patient experienced swollen lymph node under left arm causing pain. It was unknown if treatment was received for the adverse events. The events result in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
51 2021-03-15 swelling face 3 Hours after vaccination, I experienced swelling around my Left ear and Left Lower Jaw with a burni... Read more
3 Hours after vaccination, I experienced swelling around my Left ear and Left Lower Jaw with a burning sensation. The burning stopped with the fir dose of Benadryl 25mg (which I took every 8 hours for 3 additional doses) The swelling eventually decreased after 3-4 days.
51 2021-03-16 oral herpes 1/8-1/10/2021: prolong fever 102 1/8: vomiting 1/11-1/13: temp 101 to 99.9 1/8-1/16: headaches /mi... Read more
1/8-1/10/2021: prolong fever 102 1/8: vomiting 1/11-1/13: temp 101 to 99.9 1/8-1/16: headaches /migraines w/ double vision 1/11-1/16: thrush ,open fever blisters lips and mouth,+ swollen mouth, lips, tongue Treated at home w/ Tylenol q4,fluids, benadryal ,salt water mouth rinse. ice pack. Subsided 1/16/2021 . healthy prior to second vaccination
51 2021-03-17 oral herpes Mouth cold sore appeared (previous infection)
51 2021-03-17 peripheral swelling Swelling of arm began evening of injection and continues to get worse-hot, red, sore, and very swoll... Read more
Swelling of arm began evening of injection and continues to get worse-hot, red, sore, and very swollen. Headache began about 9 pm on 3/16 and is still present on 3/18. 3/17 body aches, chills, sweats, worse headache.
51 2021-03-17 swelling I received a mild rash and swelling. No big deal, and I have photos. I was happy to receive the vacc... Read more
I received a mild rash and swelling. No big deal, and I have photos. I was happy to receive the vaccine and look forward to the second injection.
51 2021-03-18 anaphylactic reaction Anaphylaxis. Five minutes after vaccination felt itching. Mouth, tongue, throat began swelling 10 mi... Read more
Anaphylaxis. Five minutes after vaccination felt itching. Mouth, tongue, throat began swelling 10 minutes after vaccination. Received Benadryl, then treated with treated with epinephrine or EpiPen. Transported by EMS to hospital where she received IV famotidine and methylprednisolone sodium succinate.
51 2021-03-18 peripheral swelling Numbness of the lips hands and feet. Swelling of the hands purple red rash a long arms. Highly eleva... Read more
Numbness of the lips hands and feet. Swelling of the hands purple red rash a long arms. Highly elevated blood pressure. Tunnel vision. Shaking. 30 minutes after receiving second vaccine for Covid.
51 2021-03-19 lymph node swelling Swollen lymph nodes ( both) at jawbones
51 2021-03-19 peripheral swelling Thursday night arm became sore, red, swollen and itchy. Took Benadryl. Next morning, not better. Arm... Read more
Thursday night arm became sore, red, swollen and itchy. Took Benadryl. Next morning, not better. Arm was hot, swollen, red, itchy and bruising occurred. All was on left arm at injection site.
51 2021-03-20 high blood cell count The day after the vaccine, pt experienced typical side effects of fatigue and fever that was control... Read more
The day after the vaccine, pt experienced typical side effects of fatigue and fever that was controlled by Tylenol. The fatigue was extreme and has continued to present day. Also, she has inability to focus and concentrate. She is nauseated daily intermittently. The main complication was in post vaccination day 5, she felt worse than before. Vertigo, nausea, extreme fatigue and inability to perform ADLs and spent most of the day in bed. Approximately 1 am the next morning she woke me, cold, clammy and pale collapsing on the side of the bed with a feeling of impending doom after having diarrhea saying ?something is really wrong.? She went back to the toilet, but had a syncopal episode from standing where she fell straight and flat on her back with no attempt to break her fall. She hit her head on the marble floor and shoe molding. She was unresponsive for 10-20 seconds with no palpable pulse or visible respiratory effort before becoming arousable. She was groggy, but oriented to person and place. She was amnestic for the event. She had an approximately 6 inch full thickness laceration to her posterior scalp that required staples. I took her BP- 85/56, pulse 50, respirations were normal. Ambulance called. Mild hypotension that responded to fluid bolus. CT of head was negative and other than non-specific leukocytosis, labs were normal (CBC, CMP, TFTs, Mg and PO4).
51 2021-03-21 swelling face Sight of injection hurt and was sore right away. After a few hours the sight of the shot became very... Read more
Sight of injection hurt and was sore right away. After a few hours the sight of the shot became very itchy and a little swollen, no redness. I felt achy and tired for rest of day. On 3/21/21 I awoke and felt very, very tired and unwell. Became incredibly nauseous, dizzy at times and had a very strong headache which lasted all day, chills, face was slightly swollen, muscle and joint aches. Injection site still hurt.
51 2021-03-22 lymph node pain Within 10 minutes I had a headache, racing heart and my tongue felt weird-tingly and numb. Within a ... Read more
Within 10 minutes I had a headache, racing heart and my tongue felt weird-tingly and numb. Within a half hour my lips tongue and throat were swollen. After an hour neck glands were sore and there were a few hives around injection site. Then I took Benadryl and the reaction didn't get any worse but continues into the next day. I have been taking Benadryl every 4 hours.
51 2021-03-22 lymph node swelling, lymph node pain Swollen lymph nodes in right side of neck. In front of ear. Per local Emergency Room, CT scan showed... Read more
Swollen lymph nodes in right side of neck. In front of ear. Per local Emergency Room, CT scan showed everything ok. Visible swelling and tender to touch for 4 weeks now.
51 2021-03-23 lymph node swelling pt reported slightly light headed ,felt like her neck was warm and left gland swollen, about 1/2 hou... Read more
pt reported slightly light headed ,felt like her neck was warm and left gland swollen, about 1/2 hour after vaccine, denied any difficulty swallowing, sob or chest pain(reported she had vaccine at other pharmacy and was fine after waiting 15 min.
51 2021-03-23 peripheral swelling Left arm swollen with big red hot knot. It was medium size early today now it?s spreaded wider and h... Read more
Left arm swollen with big red hot knot. It was medium size early today now it?s spreaded wider and hurts
51 2021-03-24 lymph node swelling Extremely swollen lymph nodes near left collarbone. Noted that injection was given relatively high ... Read more
Extremely swollen lymph nodes near left collarbone. Noted that injection was given relatively high on arm.
51 2021-03-24 lymph node swelling I experienced fever, joint pain, body aches from 12-36 hours after the injection. I experienced a sw... Read more
I experienced fever, joint pain, body aches from 12-36 hours after the injection. I experienced a swollen lymph node under the arm injected with the vaccine. Tylenol used for pain and fever.
51 2021-03-28 lymph node swelling Pfizer-BioNTech COVID-19 Vaccine Swollen lymph nodes (lymphadenopathy) left/right armpit. Left predo... Read more
Pfizer-BioNTech COVID-19 Vaccine Swollen lymph nodes (lymphadenopathy) left/right armpit. Left predominantly.
51 2021-03-28 swelling face Effects Lasted approx. 15 hours Sore Left Arm - (Expected), Tiredness, Headache, Muscle Pain, Chills... Read more
Effects Lasted approx. 15 hours Sore Left Arm - (Expected), Tiredness, Headache, Muscle Pain, Chills, Sweats, Joint Pain, Nausea, Throat felt swollen, Shallow Breathing, Swelling in Face (Left side of face for 48 hours), Weakness
51 2021-03-28 swelling Chills, fever x2 days. From shot #1. Chills, Fever x2 days, 2nd day swelling size of a quarter devel... Read more
Chills, fever x2 days. From shot #1. Chills, Fever x2 days, 2nd day swelling size of a quarter developed. 3rd day R arm swelling, hot to touch, sheering pain size half of a grapefruit. Tingling in right hand. Sought medical help.
51 2021-03-28 swelling Approximately 24 hrs after receiving my 2nd COVID Vaccine, I experienced swelling and tenderness in ... Read more
Approximately 24 hrs after receiving my 2nd COVID Vaccine, I experienced swelling and tenderness in the underarm area. As of Monday, it is slightly less tender and swollen but still has tenderness.
51 2021-03-29 anaphylactic reaction Patient developed anaphylactic reaction after vaccination. Patient pretreated with 50 mg of benadry... Read more
Patient developed anaphylactic reaction after vaccination. Patient pretreated with 50 mg of benadryl and 3 hours after vaccination had to take 50 mg more of Benadryl due to throat closing up, hives and increased heart rate. Went to physician assistant and received 50 mg Benadryl and medrol dose pak. Patient also used albuterol MDI. Symptoms resolved 6 hours after vaccination. Continued to have a headache, injection site pain and fatigue for 24 hours.
51 2021-03-29 lymph node swelling, swelling Soreness around site of shot that increased into moderate pain with mild swelling in upper arm and a... Read more
Soreness around site of shot that increased into moderate pain with mild swelling in upper arm and arm pit. Slight swelling of under arm lymph node that has resided, but the soreness persists.
51 2021-03-29 lymph node swelling Swelling in right armpit - initially swollen area was approximately 4 inches in diameter Diagnosed b... Read more
Swelling in right armpit - initially swollen area was approximately 4 inches in diameter Diagnosed by an urgent care physician as a swollen lymph node Swelling has slowly decreased; still present today - swollen area now approximately 1 inch in diameter
51 2021-03-29 swelling face The day after I received my second dose of Pfizer, I woke up with a swollen face that lasted for 2 d... Read more
The day after I received my second dose of Pfizer, I woke up with a swollen face that lasted for 2 days. My eyes, nose, cheek and lips were swollen. I also had, body aches, chill and a headache. I took Motrin, slept most of the day. The following day/day 2 most of the swelling was gone and my flu symptoms were gone. By day three all of the swelling was gone. I did not go to the doctor.
51 2021-03-30 lymph node swelling Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with... Read more
Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it)/Swell occurred 5 days post injection and remained for several days; Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding ear ache and rough throat; Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding ear ache and rough throat; Small hives on bottoms of feet and on hands; This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient received the first dose of bnt162b2 (formulation: solution for injection), via an unspecified route of administration in right arm on 30Jan2021 at 08:00 as single dose for COVID-19 immunization. The patient's medical history included psoriasis, psoriatic arthritis and lupus, and was allergic to Benzodiazepines. Concomitant medication included guselkumab (TREMFYA). The patient was not pregnant at the time of vaccination. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks and was not diagnosed with COVID-19. On 03Feb2021, the patient experienced very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding earache and rough throat. Swell occurred 5 days post injection and remained for several days. The patient also experienced small hives on bottoms of feet and on hands (the patient had psoriatic arthritis and lupus, so it was not unexpected). The patient was nervous, so underwent a COVID test on the sixth day (negative). The patient underwent lab tests and procedures on 05Feb2021 which include Qualitative PCR: negative and nasal swab: negative. 11 days out and the patient still have some lymph node swelling, but its nearly gone. The patient did not received treatment for the adverse event. The outcome of the events was recovering. Information on the lot/batch number has been requested.
51 2021-03-30 lymph node swelling swollen lymph nodes in right arm pit area
51 2021-03-30 peripheral swelling, lymph node swelling Patient received second dose of Pfizer BioNTech COVID Vaccine on 2/23/21. On 2/25 patient called PCP... Read more
Patient received second dose of Pfizer BioNTech COVID Vaccine on 2/23/21. On 2/25 patient called PCP office expressing swollen & painful lymph node to left clavicle/shoulder area . Same arm as injection. Pain 2-3/10. Pt denied any other symptoms. Managed with warm compress, however on 3/26/21 patient went to the emergency room with complaint of continued swelling and redness on left arm. Ultra sound of the upper extremity showed short segment Nonocclusive thrombus in the left proximal subclavian
51 2021-03-30 swelling face 2 hours after the shot i thought I had got bitten by a mosquito because I had an itchy raised bump o... Read more
2 hours after the shot i thought I had got bitten by a mosquito because I had an itchy raised bump on my jaw I looked in the mirror and my left side of my neck was flame red then it spread to the front of my neck then it spread to the right side. It started moving down to my chest. The rash started getting raised hives that looked like they were turning into blisters.. It was horribly itchy but the worst part is it felt like I had been scorched. Luckily I had antihistamines here on hand that eventually thank God turned it around. The next day on Monday I was in almost a comatose sleep like anesthesia I didn't know what day it was. Then on Tuesday my right side of my face went numb and felt like it was drawing down. My speech was slurry I was drooling out of my right side and I was having glitches with my memory. Today I'm still having speech difficulties gait problems and I'm hearing roaring in my ears. This is so terrifying.
51 2021-03-31 lymph node pain 1st Dose - effects surfaced apprx 5 days later - painful swollen lymph nodes 2nd Dose - effects surf... Read more
1st Dose - effects surfaced apprx 5 days later - painful swollen lymph nodes 2nd Dose - effects surfaced within hrs. Massive headache - affected peripheral vision, nausea, body aches, hot, and chills, mild dry heaves, vomitted once, weak & slightly faint, dizzy , sharp painful lymph nodes (left collar bone, Left underarm area, side of left breast, slight burning sensation, Thursday woke up with pain in back of knees, back, neck and head, in bed Wed evening through Friday, touch of diarrhea, bowel movement seemed to slightly alleviate headache, touch of stomach gas, back to work Monday, Tuesday woke up with massive headache again unable to lift head from bed, nausea, & chills unable to go to work. Wednesday back to work - got home felt fatigued slept from 5pm to 6:45 am.
51 2021-03-31 lymph node swelling Swollen armpit lymph nodes, sensitivity and left arm pain
51 2021-04-01 fluid retention, peripheral swelling I had the first shot on March 1st. My arm was a little swollen and sore for two days, and I was ext... Read more
I had the first shot on March 1st. My arm was a little swollen and sore for two days, and I was extremely tired, but other than that no adverse reaction. I received my second shot on March 19th, my arm again swollen and sore, and I could barely keep my eyes open the rest of the day. On 3/20/21, I woke at 8:30, feeling like I had hardly slept at all even though I had slept for 9 hours. I woke up wheezing, which led to me coughing and chills but no fever. The exhaustion I had felt after the first shot, was nothing compared to this. I thought it would go away, but it didn't. I also noticed a lot for fluid retention in my lower legs and stomach area. When I got on the scale, in the 20 days from the 1st shot til the day after the second shot I had gained 20 pounds of fluid. I was stunned. I could barely do a simple task, then I would have to sit down to rest for a minute, and would immediately fall asleep for 2 to 3 hours. I went to my doctor's on 3/22/21. They did a covid test, it was negative. The doctor said I was definitely wheezing and gave me the only sample inhaler that they had in stock Anorro to try to open up my airways. After a week, I was still having the issues, went back to doctor on 3/29/21 This time they perscribed 12 days of taper steroids. I am on day 4. I also received a referral to see a pulmonary specialist. I am still dealing with the exhaustion, wheezing and cough.
51 2021-04-01 lymph node pain 25 hrs after injection I was tired, muscle and joint aches, low grade fever, slight stomach upset an... Read more
25 hrs after injection I was tired, muscle and joint aches, low grade fever, slight stomach upset and had moderate lymph node pain( below armpit of injection arm).
51 2021-04-01 lymph node swelling, lymph node pain SWOLLEN LYMPH NODE UNDER ARM OF INJECTION SITE. SEVERE PAIN ON INJECTION SITE. HEADACHE. BODY ACHES.... Read more
SWOLLEN LYMPH NODE UNDER ARM OF INJECTION SITE. SEVERE PAIN ON INJECTION SITE. HEADACHE. BODY ACHES. SOME CURRENT RESIDUAL SWELLING AND SORENESS OF LYMPH NODE.
51 2021-04-01 peripheral swelling itching of hands and feet, swelling of hands and feet, shortness of breath
51 2021-04-01 swelling face very puffy and swollen face around eyes. Left eye mostly affected. Red and dry skin around eyes. V... Read more
very puffy and swollen face around eyes. Left eye mostly affected. Red and dry skin around eyes. Very irritated and painful. Healing, but still evident today.
51 2021-04-02 lymph node swelling, lymph node pain Sore and swollen left axillary lymph node x 3 days, headache x 3 days, low grade fever x 12 hours, d... Read more
Sore and swollen left axillary lymph node x 3 days, headache x 3 days, low grade fever x 12 hours, dizziness and nausea x 12 hours, fatigue x 3 days
51 2021-04-02 swelling, lymph node swelling, peripheral swelling headache; arm started aching; The lymph nodes in her arm are still swollen; Swelling in the armpits ... Read more
headache; arm started aching; The lymph nodes in her arm are still swollen; Swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/It is both armpits; Swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/It is both armpits; itching on both of her feet; red circle where she got the injection. It was the size of a dime and only there on 28Jan2021; arm that she got the vaccine in got very large; Swelling in the upper breast area/swelling in her upper chest; Swelling and pain in the neck/Neck pain; Swelling and pain in the neck/Neck pain; This is a spontaneous report from a contactable consumer. A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 15:00 as single dose for covid-19 immunization.Medical history included menopause or has been through menopause, Flu shot, hormonal issues, she started with a bizarre virus, whole lymph node response; It was lymph nodes in her neck, arm pits, and groin. Every two days she would have lymph nodes reacting, she had a little infection and inflammatory markers come back positive. Concomitant medication included probiotics, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). The patient previously took flu for influenza immunisation and experienced peripheral swelling, tetanus vaccine for immunisation, amoxicillin, and experienced drug hypersensitivity, flagyl [metronidazole] and experienced drug hypersensitivity. The patient reported adverse events associated with her first Pfizer COVID vaccine shot. She experienced swelling in the upper breast area, swelling and pain in the neck, swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared. She thought on whether to get the second shot of the vaccine considering these side effects since her doctor did not know why this was happening according to her. She thought she would report some side effects after one shot of the Pfizer COVID19 Vaccine. It was strange. She did not read the symptoms until seven days out. Then she saw some have reported a lot less. After the shot, that night she had swelling in her upper chest. She thought it was lymph nodes in the breast and chest area on the side she got the shot. The next day her arm that she got the vaccine in got very large. Then, she does not know if it was related, two days later she had itching on both of her feet. It was the tops of her feet and only for a couple of days. She is not counting that. Day five after the shot has been the main problem. Her armpits started itching like crazy. It was severe itching and swelling in her armpits. The itching lasted for three to four days. The lymph nodes in her arm are still swollen. It was five days after the shot. It was both armpits. The night of the shot she had a lot of neck pain and she thought it was probably the lymph nodes in the back of her neck. That has lasted and was slowly diminishing. The patient was not planning on getting it. There was an agency that for assisted living for people that need help. They were giving it and had extra doses. This guy in charge at the assisted living house offered it to caller and caller's husband because her and her husband run a behavior health counseling. He offered it to them as healthcare professionals. He was given a batch for the residential agency but had extras. She was going through menopause or has been through menopause. She has hot flashes and has hormonal issues. The first week of December she started with a bizarre virus. She got tested for COVID and it was negative. It was not a rapid test it was a sendoff. Through that illness she had a whole lymph node response which was super unusual. The doctor said it was really strange. It was lymph nodes in her neck, arm pits, and groin. Every two days she would have lymph nodes reacting. She had recovered from that and was back to normal. Four days before she got the shot all of that had resolved. Prior to getting the vaccine she had been tested for Lymphoma and it was negative, and she had a little infection, and her white blood count was normal. She had inflammatory markers come back positive prior to getting the vaccine. She went to the doctor on 27Jan2021 and asked if she should get the shot. The doctor said to do it because if she got COVID it would be worse. She was going to have a follow up with doctor for the ongoing stuff and he might do more test. Never in the course of any of that did she have itching armpits or swelling that lasted all this time. She never had chest swelling. The shot in the arm and it moved across her chest. It was reported that, back in the 90's, in 1993 or 1994, flu shots caused her arm to swell really large and stayed swollen for three months. That was the last three flu shots she got in the 90's. Then the doctor said not to get them. No one said why. She doesn't have allergy to eggs or anything that she knows to cause that. She has gotten all other vaccines and tetanus within the last 10 years. Her arm would kind of react but not like that. It went away in a reasonable amount of time. She didn't get a fever. The patient does not have NDC, lot and expiry for flu shots, other vaccines or tetanus to provide. When her kids were younger, they all had to be vaccinated for rabies. She did not have any reaction at all with those vaccines. She has allergies to antibiotics. She does not have lot numbers, NDC, or expiry for the antibiotics she was allergic to. She was allergic to Amoxicillin, Flagyl, Doxycycline, and Sulfa drugs. She has allergies to adhesive and contrast dye. No food allergies. She has allergies to dog and other environmental allergies. She does not take any medications for any of that. She has never had any anaphylactic shock of any kind. It has always been hives. The patient experienced swelling in the upper breast area/swelling in her upper chest, swelling and pain in the neck/neck pain, swelling and pain in the neck/neck pain, swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/it is both armpits, arm that she got the vaccine in got very large, itching on both of her feet, red circle where she got the injection. It was the size of a dime and only there on 28jan2021, headache, arm started aching and the lymph nodes in her arm are still swollen. Outcome of the events Swelling in the upper breast area/swelling in her upper chest and arm that she got the vaccine in got very large was recovering, outcome of the events Swelling and pain in the neck/Neck pain, Swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/It is both armpits, itching on both of her feet and red circle where she got the injection. It was the size of a dime and only there on 28Jan2021 was recovered and outcome unknown for other events. Information on the lot/batch number has been requested.
51 2021-04-04 swelling face 8:45-Vaccinated 9:20- C/O lightheadedness, tingling-throat/dry throat, facial swelling Vital signs w... Read more
8:45-Vaccinated 9:20- C/O lightheadedness, tingling-throat/dry throat, facial swelling Vital signs within normal, O2 sat 98-99 Symptoms improved after given water and observed in recumbent position. 9:50 discharged home.
51 2021-04-05 lymph node pain, lymph node swelling Swollen/tender lymph nodes under left arm
51 2021-04-06 lymph node pain, lymph node swelling Fever and chills, INTENSE body/joint pain - into the bones, tired, left armpit swollen (lymph glands... Read more
Fever and chills, INTENSE body/joint pain - into the bones, tired, left armpit swollen (lymph glands maybe), headache. Feels like COVID all over again. Fever appears to be gone this morning. Aches are significantly better but not great. Concerned about the large swelling under left armpit. It is painful.
51 2021-04-06 peripheral swelling 4/2/2021 11pm left hand red swollen 4/3/2021. Extreme fatigue slept 18 hours very exhausted all day ... Read more
4/2/2021 11pm left hand red swollen 4/3/2021. Extreme fatigue slept 18 hours very exhausted all day and night, woke up with face tingling from top of scalp to top of lips across entire area left to right . 4/5/2021. Chills and diarrhea, still fatigued and facial tingling continues 4/6/2021 tingly face continues 4/7/2021 tingly face continues
51 2021-04-06 peripheral swelling arm swollen, red, rash
51 2021-04-06 swelling Approximately 2.5 hours after vaccination, I experienced difficulty breathing, overheating, and a se... Read more
Approximately 2.5 hours after vaccination, I experienced difficulty breathing, overheating, and a sensation of my head, neck, and chest swelling up. Emergency inhaler was used. Ice packs were applied to head and chest areas for 45 min. Breathing eased up slightly after about an hour. Tightness in chest and neck for next 4 hrs. Continued bouts tightness in chest and neck with labored breathing, lightheadedness, and vertigo over next 8 days. Took Zyrtec 2 times daily, inhaler 3 times daily, and Flexeril 2 times daily. Went to Urgent Care on day 8 after calls to allergy dr and gp dr were not returned. Prescribed Prednisone to help with inflammation.
51 2021-04-08 lymph node swelling, lymph node pain Swelling of lymph nodes both right and left sides cervical, axillary and pectoral with mild discomfo... Read more
Swelling of lymph nodes both right and left sides cervical, axillary and pectoral with mild discomfort. Most notably on the left side there are 3 supraclavicular lymph nodes that are so swollen they are visible to the naked eye and are painful to touch/pressure (ex. seat belt strap).
51 2021-04-08 swelling face I got the shot on Satruday and then that evening, my arm was sore as expected. I had a little someth... Read more
I got the shot on Satruday and then that evening, my arm was sore as expected. I had a little something under my eye. Looked like a little bite. On Sunday, on my face I had what looked like sunburn under each of my eyes and on the side of both of my face. It felt tingly. The redness was there day into Sunday night. I took some Benedryl. On Monday, the red was gone but my eyes were puffy and had some swelling to my face and still had tinglng in my face. I called my PCP and she asked that I come in and see her. On Monday, I had a visit with my PCP, there was stil some swelling around my eyes. She was going to report it and would let me know if I could take DOSE 2. I was advised to not take DOSE 2. It was all better by Wednesday.
51 2021-04-08 swelling face tingling in right arm and leg, pain in left arm and leg, weakness in left arm and leg, swollen right... Read more
tingling in right arm and leg, pain in left arm and leg, weakness in left arm and leg, swollen right side of face, chest pain, and fatigue
51 2021-04-10 c-reactive protein increased Acute onset of chest pain at 2:00 am on 4/8/21. Arrived at ER via ambulance at 4:30 am. Chest pain w... Read more
Acute onset of chest pain at 2:00 am on 4/8/21. Arrived at ER via ambulance at 4:30 am. Chest pain was extreme pressure, in chest radiating up through neck and lower left chest. Constant, worse when lying down or breathing deeply. Evaluated in ER and subsequently admitted to the hospital. Diagnosed: Acute Idiopathic Pericarditis.
51 2021-04-10 lymph node swelling I had s these symptoms after both shots:fever, headache, flu symptoms, swelling all over including e... Read more
I had s these symptoms after both shots:fever, headache, flu symptoms, swelling all over including eyelids, joint pain. On 4/11, 11 days after second shot I developed burning/stinging nerve pain throughout body. Went to ER. All tests normal except my abdominal lymph nodes are swollen. Only mild pain relief with morphine. Being referred to a neurologist. Have never experienced this before. Only history of nerve damage is an injury in right foot. In extreme pain with no explanation yet.
51 2021-04-10 peripheral swelling Swelling in hands, itching in hands and peeling of skin, as well as 2 days of vomiting - reported by... Read more
Swelling in hands, itching in hands and peeling of skin, as well as 2 days of vomiting - reported by patient.
51 2021-04-10 swelling face Tingling and numbness from the bottom of my neck to the top of my head on the left side and the top ... Read more
Tingling and numbness from the bottom of my neck to the top of my head on the left side and the top 1/4 of my head on the right side. Numbness in my mouth and on the top of my tongue, but it did not affect my breathing or ability to speak. Swelling and tightness of my left cheek. The numbness/tingling lasted for 2-3 hours. The swelling lasted for about 3 full days. My mother called the Board of Health who said I should lay down. It helped. When I sat up, it started to spread again, so I laid down for about one hour. I later contacted my physician to see if I should get the 2nd shot.
51 2021-04-11 lymph node pain PT REPORTED ON 4/12/21 THAT DURING THE 15 MINUTE WAIT SHE WAS EXPERIENCING CHEST PAIN AND ELEVATED H... Read more
PT REPORTED ON 4/12/21 THAT DURING THE 15 MINUTE WAIT SHE WAS EXPERIENCING CHEST PAIN AND ELEVATED HEART RATE. HER HUSBAND TOLD HER IT WAS HER ANXIETY. ABOUT TWO HOURS LATER SHE DEVELOPED DIZZINESS AND COLD SWEARS. SHE IS ALSO EXPERIENCING LYMPH NODE PAIN.
51 2021-04-12 lymph node swelling, lymph node pain Swollen painful lymph node appeared on left collarbone 3 days after the injection. It resolved 2 day... Read more
Swollen painful lymph node appeared on left collarbone 3 days after the injection. It resolved 2 days later and had now reappeared the morning of the 14th day after injection.
51 2021-04-12 swelling face My shot was given in my left arm and the right side of my face became flush and slightly swelled - t... Read more
My shot was given in my left arm and the right side of my face became flush and slightly swelled - treated with benadryl
51 2021-04-13 peripheral swelling Lump in arm, redness, looks like there is a sore in that spot, entire arm is constantly in pain and ... Read more
Lump in arm, redness, looks like there is a sore in that spot, entire arm is constantly in pain and throbbing
51 2021-04-13 peripheral swelling 1. Swollen left underarm on shot arm presumed to be swollen lymph nodes. Did not go to Doctor. P... Read more
1. Swollen left underarm on shot arm presumed to be swollen lymph nodes. Did not go to Doctor. Pain also in shoulder blade as if lymph nodes swollen there also. Lasted over a week. 2. I was going through early stages of menopause. Hot flashes, night sweats, stopped ovulating, haven't menstruated in 8 months. Since the 2nd shot, about 5 days post vaccination, I have not had a single hot flash or night sweat. I also ovulated and it is to be seen if it brings my menstrual cycle back. Not a bad event, just thought it may be needed to be known if some women are on hormones, etc, as it may affect that.
51 2021-04-14 lymph node pain, lymph node swelling Body aches and chills starting around 11:30pm 4/12/21 persisting through next day. No fever. Resolv... Read more
Body aches and chills starting around 11:30pm 4/12/21 persisting through next day. No fever. Resolved by 4/14/21 Left axillary lymph node soreness and swelling, noticed 6am 4/14/21. Resolved throughout the day (took one dose of 400mg ibuprofen at 9am). Swelling returned - noticed at 6am 4/15/21. Took 400 mp ibuprofen at 8:30am.
51 2021-04-15 lymph node swelling, swelling face Patient reports that her symptoms started within 5 minutes of getting the vaccine. Started with fac... Read more
Patient reports that her symptoms started within 5 minutes of getting the vaccine. Started with facial numbing then followed by a bad headache and joint pain all happening within 15 minutes. Facial numbness was her first symptom that started. In the next hour she had chills, scratchy throat, itchy and dry eyes. Slept the rest of the day. The following day she had headaches, chills terrible body aches. 4/12/21 she developed facial swelling under her chin, lymph nodes inflamed/enlarged, chills, body aches, slight headache, cough. Took IB to help with symptoms. She still continues to have side effects today, (4/16/21) which include body aches, fatigue and still "not feeling right."
51 2021-04-15 lymph node swelling Experienced arm pain at injection site starting about 12 hrs after shot. About 24 hrs later, felt a... Read more
Experienced arm pain at injection site starting about 12 hrs after shot. About 24 hrs later, felt armpit pain on same side so likely swollen lymph nodes? Took ibuprofen evening of 4/9 with some relief. Now have dull pain left breast area/armpit a week later.
51 2021-04-15 lymph node swelling 3 large swollen lymph. Nodes discovered approximately 5 weeks after 2nd vax. Now at 11 weeks, still ... Read more
3 large swollen lymph. Nodes discovered approximately 5 weeks after 2nd vax. Now at 11 weeks, still present and unchanged in size.
51 2021-04-15 lymph node swelling Notice trobbing along the back of my ear, and noticed there were two knots had formed and causing so... Read more
Notice trobbing along the back of my ear, and noticed there were two knots had formed and causing some discomfort.
51 2021-04-16 peripheral swelling, lymph node swelling, lymph node pain High fever (101.9 by thermometer) and Swollen painful lymph node approximately an hour after the vac... Read more
High fever (101.9 by thermometer) and Swollen painful lymph node approximately an hour after the vaccine. Now the lymph node is larger and my arm is swollen?pain radiates from my left armpit down-past my elbow and towards my chest muscle.
51 2021-04-16 peripheral swelling Parked car after injection which was painless. Pain at wrist and tingling in hand. Right arm from w... Read more
Parked car after injection which was painless. Pain at wrist and tingling in hand. Right arm from wrist to scapula swollen and in pain. Pain at neck and couldn't tell if swollen. Lasted through the next day. Persistent right hand tingling lasted over 24 hours. Had to use left hand to type for work.
51 2021-04-17 lymph node swelling, lymph node pain Painful swollen lymph node in the left armpit (same side as injection), visible about the size of a ... Read more
Painful swollen lymph node in the left armpit (same side as injection), visible about the size of a golf ball. OTC pain medication (Motrin) helps as long as I continue to take. Without the OTC, pain is constant, even at rest. Also experience extreme fatigue for 3 days. The lymph node swelling is ongoing as of today (4/18).
51 2021-04-17 lymph node swelling Swollen lymph node above left collar bone with tenderness
51 2021-04-17 lymph node swelling Rash under left arm; Swollen lymph node; This is a spontaneous report from a contactable consumer (p... Read more
Rash under left arm; Swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (non-pregnant) received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, (Batch/Lot number was not reported), via an unspecified route of administration at the age of 51-year-old at arm left on 26Mar2021 09:00 at single dose for COVID-19 immunization. Medical history was not reported. The patient wasn't allergies to medications, food, or other products. Concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient experienced rash under left arm and swollen lymph node on 28Mar2021. The patient hasn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient hasn't received other medications within 2 weeks of vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There was no treatment for events. The outcome of events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained
51 2021-04-17 swelling face Rcvd injection at 10 am, 10:05 am rapid heartbeat, dizziness, weak. Sat down. 10:20 am heartbeat st... Read more
Rcvd injection at 10 am, 10:05 am rapid heartbeat, dizziness, weak. Sat down. 10:20 am heartbeat steadied, still a little disoriented but able to leave facility. 10:25am, left side of face swelled up. 10:30 am, in bed, slept for 3 hours, profuse sweating. Upon waking up, tired, swollen left side of face, headache, sore throat, injection site and other muscle pain. Back to bed 8pm, same symptoms. Sunday morning the 18th 8 am drenched with sweat, injection site pain, swollen left side of face. By noon, after taking daily medications and shower, cold compress on left side of face, swelling down, still feeling tired, but overall feeling better.
51 2021-04-18 lymph node pain, lymph node swelling Headache, stomach ache, injection site ache, swollen and painful lymph nodes, and mild fever next da... Read more
Headache, stomach ache, injection site ache, swollen and painful lymph nodes, and mild fever next day, dizziness and nausea started 3 days later
51 2021-04-18 lymph node swelling Had 2nd Pfizer shot in upper left arm. Developed swollen lymph nodes under left arm pit.
51 2021-04-18 swelling face At 1:29PM, shortly after vaccine administered, patient experienced facial swelling and difficulty br... Read more
At 1:29PM, shortly after vaccine administered, patient experienced facial swelling and difficulty breathing and epinephrine was administered and 911 was called. Patient experienced increased airway secretions, complained of headache and swelling improved with the epinephrine. Vitals: BP 138/98 mmHg, HR 76 beats per min, PO2 98% At 1:36PM facial swelling increased, lungs diminished, and a second epinephrine injection was administered. At 1:40PM EMS arrived, angioedema improving, secretions improving, and patient transported by EMS to emergency department.
51 2021-04-18 swelling face Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Ton... Read more
Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: leg pain-Mild, Additional Details: pt complained of fatigue, hives over upper half of body starting the day after vaccination and leg/thigh pain starting two days after vaccination
51 2021-04-19 peripheral swelling Legs swelled up and turned red. Leg swelling was so bad I couldn?t put my shoes on for one week afte... Read more
Legs swelled up and turned red. Leg swelling was so bad I couldn?t put my shoes on for one week after the shot and it didn?t return to normal for a few weeks after the shot. I also had night sweats beginning the night I received the Pfizer shot and they have continued - every night, since that time and currently have them. I also had moderate to severe pains in my hips, low back and legs more so, but all over my body it was painful in my muscles. This has not completely gone away. My strength in my legs and back was also less and created a limitation in my walking- I normally walk 10,000 steps everyday, but have to stop every 3,000 steps and sit down because of the pain and reduced strength in my hip and back. had headache and mild coughing, but that went away.
51 2021-04-20 lymph node swelling Chills, body aches, extreme exhaustion, headache, soreness at injection site, swollen lymph glands i... Read more
Chills, body aches, extreme exhaustion, headache, soreness at injection site, swollen lymph glands in armpit of injection arm
51 2021-04-20 peripheral swelling, lymph node swelling All my muscles and whole body is hurting; All my muscles and whole body is hurting; Chills; Joint pa... Read more
All my muscles and whole body is hurting; All my muscles and whole body is hurting; Chills; Joint pain; I had some wired nausea, I can even hardly eat; I had some wired nausea, I can even hardly eat; My heart rate is kind of low but it's been 125 for last 2 days; I have a rash; I feel dizzy and weak; cannot stand up and walk; I feel dizzy and weak; cannot stand up and walk; I feel dizzy and weak; cannot stand up and walk; My lymph nodes are very swollen; I have ray nods also that's circulation disorder; I feel like I have been freezing cold ever since I got the second shot; I got half fever; I have ray nods also that's circulation disorder; I feel like I have been freezing cold ever since I got the second shot; I got half fever; I have been passed out; I had mine my fever gone up to 104.9 and down to 103; my arm is swollen, hard and hurts terribly; my arm is swollen, hard and hurts terribly; whole arm get deep red; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, in the left arm on 01Apr2021 (Batch/Lot Number: EN6199) (at the age of 51 years old) at a single dose for covid-19 immunisation. Medical history included lupus and high blood pressure both from an unknown date. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonazepam (KLONOPIN) and topiramate (TOPAMAX) all taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 12Mar2021 (lot number: EN6198) (at the age of 51 years old) and reported that she was really not feeling well. On 01Apr2021, the patient got the second dose of covid vaccination and reported that she had a pretty serious side effect since the first one. The patient then reported her fever gone up to 104.9 and down to 103 and reported that she was worried about herself, not only the fever; her arm is swollen, hard and hurts terribly; patient reported that all her muscles and whole body is hurting and the chills, the joint pain of course the fever and further reported that had some wired nausea, she can even hardly eat. The patient then stated that within a few hours after her shot, she started having mild problems: swelling of her arm, her whole arm get deep red and throughout pain in her arm. The patient had a video call with her primary care doctor, the doctor said it's just normal, don't worry about it, the doctor didn't let the patient give all her symptoms (as reported). The patient further stated she have that pain and something is not right in her body and that she have been taking Tylenol. The patient also reported that her heart rate is kind of low but it's been 125 for last 2 days (as reported), patient reported that she has a rash, feel dizzy and weak, cannot stand up and walk, the patient have attended to go for her family house for the Easter and she was there for 15 minutes. Keep in mind Covid normally they all were vaccinated and it's been a very special time, but within 15 minutes the patient have been passed out and had been taking home and further reported that her lymph nodes are very swollen and her head is killing her. The patient have an electric blanket in her arm because she have chills so bad, her joints are hurting and she have ray nods (as reported) also that's circulation disorder and she feel like she have been freezing cold ever since she got the second shot. The outcome of the events was unknown.
51 2021-04-20 swelling face, swelling, anaphylactic reaction Experienced severe allergic reaction resulting in anaphylaxis requiring emergency treatment @ ER. S... Read more
Experienced severe allergic reaction resulting in anaphylaxis requiring emergency treatment @ ER. Swelling of face and neck, eyes swollen shut, hives on upper body, difficulty breathing.
51 2021-04-20 white blood cell count increased Double-vision due to misalignment of left eye. Examination resulted in a diagnosis of 6th nerve pals... Read more
Double-vision due to misalignment of left eye. Examination resulted in a diagnosis of 6th nerve palsy. Symptoms remain after two weeks, with slight improvement.
51 2021-04-21 lymph node pain, lymph node swelling Bicep hurting lymph node in left shoulder neck swollen an painful big knot coming up out of shoulder... Read more
Bicep hurting lymph node in left shoulder neck swollen an painful big knot coming up out of shoulder which is swollen lymph node cant lift left arm more than halfway was at cardiologist office this morning having echocardiogram an showed the lady she said i need to report this that all the swelling looks like golf ball in node the pain going all the way around back of neck an into other (right shoulder) was told that by noww 22cnd april that this shouldnt be happening that side effects shoulda done be gone
51 2021-04-22 swelling Pain reappeared at injection site about 10 days after injection. Pain radiated upward towards neck ... Read more
Pain reappeared at injection site about 10 days after injection. Pain radiated upward towards neck and was red and hot and there was swelling in my neck area, as well for 2 full days. Pain in neck area has since gone away, but there is still ongoing pain at the injection site. Daily headaches, nausea and sever fatigue, have been ongoing since the pain has come back. These symptoms are still happening.
51 2021-04-23 lymph node swelling Sore arm, swollen lymph nodes under left arm, metallic taste in mouth, 101 degree fever, chills, mus... Read more
Sore arm, swollen lymph nodes under left arm, metallic taste in mouth, 101 degree fever, chills, muscle aches, headache
51 2021-04-24 lymph node swelling Extremely swollen lymph node on collar bone. Tender and fire with movement.
51 2021-04-24 peripheral swelling Body aches, stiffness (especially lower back and hips), fatigue, swelling in left arm pit.
51 2021-04-25 lymph node inflammation approx. 12 min after shot , I started to notice a sharp pain at the base of my skull bone, behind my... Read more
approx. 12 min after shot , I started to notice a sharp pain at the base of my skull bone, behind my ears. pain lasted about 20 min. around 7:00 pm that night I started having lymph node swelling under my left arm. around 7pm I started having pain in my right achilles tendon. The lymph node swelling lasted approx. 3.5 days. The achilles tendon pain last about 24 hours.
51 2021-04-25 swollen extremities 40 minutes after receiving vaccine, patient had trouble swallowing and throat feeling "tight". Patie... Read more
40 minutes after receiving vaccine, patient had trouble swallowing and throat feeling "tight". Patient then proceeded to Emergency Center, was given IV Benadryl then discharged. Bruises started 4/15/21 on right arm, 3 bruises inner arm, 1 bruise to outer arm, bruise on wrist, right side of abdomen, and left ankle has edema, soreness and is pruritic. Pruritic symptom has resolved but still edematous. Recommended to contact provider if symptoms worsen. /22/21- Follow up: Patient stated she went to the ER on Monday 4/19/21 due to her concern of bruising on body and a little spots on body (but not itchy) that started. She stated blood work was done in the ER and it was normal she was informed that other than her lymphocytes were low it was nothing concerning . CT scan on head was normal. No fever, body aches, sob, chest pain. She stated that some of her bruises are starting to fade and the rash is still the same. Advised patient to monitor herself if spots get worse or itchy she can apply benadryl cream or hydrocortisone cream. Will follow back up on monday 4/26/21. , PharmD 4/26-Called the home and there was no answer. Message was left to call the covid hotline for further follow up.-JD
51 2021-04-25 oral herpes, lymph node pain Day 4 - Left underarm lymphe node painful Day 16 - Cold sore (Herpes Simplex HSV1) - Taking acyclovi... Read more
Day 4 - Left underarm lymphe node painful Day 16 - Cold sore (Herpes Simplex HSV1) - Taking acyclovir 2 tablets 12 hours apart
51 2021-04-25 swelling patient had throat/tongue/mouth tingling, swelling, throat closing sensation within 15 minutes of ad... Read more
patient had throat/tongue/mouth tingling, swelling, throat closing sensation within 15 minutes of administration of vaccine. She tells me she was administered benadryl, "steroid" and epi-pen and was transported to Hospital ER for observation where she was discharged home with epi-pen prescription.
51 2021-04-26 peripheral swelling At midnight I was running a fever, chills, aches and legs swollen.
51 2021-04-27 lymph node swelling Headache and achy the next two days. Day three swollen lymph nodes in left armpit for next three wee... Read more
Headache and achy the next two days. Day three swollen lymph nodes in left armpit for next three weeks. Third week, swollen lymph nodes in both armpits and groin area. Vomiting, nausea , headache and severe fatigue since vaccine and still continues.
51 2021-04-27 lymph node swelling Immediately after injection it felt as if My throat was being choked & my throat started to burn ...... Read more
Immediately after injection it felt as if My throat was being choked & my throat started to burn .... it lasted for about an hour.... after I was left with a horse sore throat & my esophagus hurt.... it still is hurting ....
51 2021-04-27 swollen extremities Painful, swollen underarm (left);
51 2021-04-27 swelling face Facial swelling (eye, tongue, lip), high BP, high HR, shaking, lower O2 (95), monitored for over an ... Read more
Facial swelling (eye, tongue, lip), high BP, high HR, shaking, lower O2 (95), monitored for over an hour while hooked up to BP machine and pulse oximeter, epi was brought out and kept nearby but not administered. Continued for several hours after I got home. Also had severe uterine cramping for about 12 hours even though I am in menopause.
51 2021-04-29 lymph node swelling 2 inch diameter swelling in left axilla (lymphadenopathy?)
51 2021-04-30 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium
51 2021-04-30 lymph node swelling Mild lymphadenopathy at right arm for two days starting on the second day after the injection
51 2021-04-30 peripheral swelling An hour or two after getting the FIRST Pfizer vaccine, my kids noticed my palms were bright red. The... Read more
An hour or two after getting the FIRST Pfizer vaccine, my kids noticed my palms were bright red. The veins in my fingers, palms and wrists looked swollen too. Today, I looked at a recipe I copied off the internet a few hours after the vaccination. I misspelled 6 words. (The word cup was misspelled "cub" and "cube", the word tablespoon was "tblsoops", chill was "chil", etc.) This is not normal for me. The next day, my palms were no longer red and the veins were back to normal. I did have any other reactions. I suspect our family had covid last March because my husband and I had symptoms that would later be added to the list. (loss of taste, digestive issues, dizziness, heart racing in addition to sore throat, body aches, breathing difficulty) My husband and I were sick for about 3 weeks then 3 weeks recovering. Our kids had a sore throat for 2-3 days only.
51 2021-04-30 swelling Hives, swelling, soreness, hot to touch
51 2021-05-02 lymph node swelling The evening of my second vaccine injection, I started feeling pain in my inner thigh/groin area. The... Read more
The evening of my second vaccine injection, I started feeling pain in my inner thigh/groin area. The pain started getting worse in the second week after the injection. It hurt when I walked, sat, bent down to pick up something. The second week after I also developed pain in my left arm on the outside of arm, but had pain when I lifted my arm. The pain was worse at and through the night and in the morning, seemed to get a little better as I moved. The third week, the pain in my groin area had some relief while the pain in my arm spread to the other arm and both arms now have pain. It is increased when I try to lift over my head making it difficult to wash, brush hair and also to get dressed. Hurts more at night and in morning but once I get going seems to get better. Starting 5/1/21 the pain came back in my leg and now continues to the other leg. Both arms now are still hurting. The left side seems to be worse, but both sides hurt. I can't get comfortable when I sleep, so I am up tossing and turning. Also hard to get in and out of bed and also up and down on furniture.
51 2021-05-02 lymph node swelling I was feeling fine only I felt a bubble near my collar bone tender swelling went to emergency room w... Read more
I was feeling fine only I felt a bubble near my collar bone tender swelling went to emergency room went to ER at 8:30am Dr checked my neck said i had Acute Lymphadentitis Unspecified - Lymphadenopathy no blood taken or scans made this assesment was by Touch and visual . I was prescribed an antibiotic DoxycyclineHyclate 100 mg 1 capsule by mouth twice a Day was told to get a mammogram after so i will take one 6 weeks after injection to make sure
51 2021-05-02 lymph node swelling Light headed at first, but subsided after about 10 minutes. Inj. sight was very tender & sore for 4... Read more
Light headed at first, but subsided after about 10 minutes. Inj. sight was very tender & sore for 4 days. It hurt to even move my arm. Lymph node under shot arm was very swollen & sore. I could not raise my arm, reach or carry anything of weight with injected arm. Neck muscles & back also seemed to be "stiff". All side effects seem to disappear on or about day 4.
51 2021-05-03 swelling face Pt recieved vaccination and departed after her observation period. She returned to the site shortly ... Read more
Pt recieved vaccination and departed after her observation period. She returned to the site shortly after reporting very mild facial swelling, rash to neck/chest, tingling and "a tickle in her throat." Initially she denied SOB, cough, tongue/airway swelling. HR 150/80, HR 87, SP0298%, RR: 16 unlabored. Small areas of erythema were appreciated to lateral neck and upper chest. No facial swelling, tongue/mouth swelling appreciated. No wheezing heard. Pt was given 50mg of Benadryl and 911 was called . At time of EMS transport, the pt developed a cough but vital signs remained WNL.
51 2021-05-04 lymph node swelling Substantial swelling and pain in left arm pit in lymph nodes
51 2021-05-04 lymph node swelling Apnea episodes, felt like she couldn't breathe; rash, small tiny pimple a rash; she could barely swa... Read more
Apnea episodes, felt like she couldn't breathe; rash, small tiny pimple a rash; she could barely swallow; Ears were itching, scratching her arms; Ears were itching, scratching her arms; really, really sick; Sore throat; throat and gland started swelling really big; throat and gland started swelling really big, glands were swollen; complaining about stomach; I noticed that my ear started swollen so bad; it is like an allergic reaction; Severe Flu-like symptoms, COVID-like symptoms; Migraine from back of her head, headaches; This is a spontaneous report from a contactable consumer reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 13Apr2021 (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Lyme disease. Concomitant medication was none. On 14Apr2021, the patient experienced severe flu-like and COVID-like symptoms which included body aches which was very strong, and feeling feverish, she was complaining about stomach, her throat and gland started swelling really big, her ear started to swell so bad, it is like an allergic reaction. On 15Apr2021, the patient experienced sore throat, and she got really, really sick. On 16Apr2021, the patient experienced glands were swollen, she could barely swallow, ears were itching, and she was scratching her arms. On 18Apr2021, the patient experienced I had rash, small tiny pimple a rash. On 19Apr2021, the patient experienced apnea episodes, felt like she couldn't breathe. On an unspecified date in Apr2021, the patient experienced, migraine from back of her head, headaches. On 16Apr2021, the patient went to urgent care, and she was tested for COVID, strep, influenza and they did a urine test, because she was also reporting stomach aches and pulmonary test. All the test results were negative. Cultures, to the previous tests were performed and everything was negative. The events required and emergency room visit and the emergency room doctor, didn't think it was an allergic reaction to the vaccine, because it took so long, to happen. The patient was treated for the events in the emergency room, with steroids, Benadryl and an intravenous infusion. The patient said that she was fine now. The outcome of the events was recovered on an unspecified date in Apr2021. Information on the lot/batch number has been requested.
51 2021-05-08 swelling, peripheral swelling Diagnosed with Rheumatoid arthritis involving multiple joints and Hypogammaglobulinemia officially o... Read more
Diagnosed with Rheumatoid arthritis involving multiple joints and Hypogammaglobulinemia officially on 5-6-2021 after extensive lab work. Symptoms began Feb 26, 2021. Right and left hand/shoulder/wrist/elbow/arm swelling, redness, pain.
51 2021-05-10 swelling Site: Pain at Injection Site-Medium, Systemic: swelling near the neck-Mild
51 2021-05-11 swelling i was the only one out of the 4 of us that the vaccine shot was painful. that afternoon my entire ... Read more
i was the only one out of the 4 of us that the vaccine shot was painful. that afternoon my entire body was extremely painful, i felt nauseous, i was scared, had chills, and could not eat. i cried multiple times it was so painful. i did not feel pain free until 2 days later. my arm on the second day has a hot red rash that is spreading and the size of a baseball. i plan on going to a clinic to have it looked at to make sure it is ok. the other 3 family members that got the vaccine at the same time did not have pain when the needle went in , only had a sore arm and mild chills the next day.
51 2021-05-12 lymph node swelling client stated that 24 hours post initial vaccination client developed rash on inner thighs and genit... Read more
client stated that 24 hours post initial vaccination client developed rash on inner thighs and genitals and swelling to lymph nodes under left arm and side of left breast. The rash got better with benadryl then resolved after 3 days. The swelling to lymph nodes have not yet resolved.
51 2021-05-12 swollen extremities On 5/5/2021 pt says the left side of her body became very sore from her shoulder to her elbow. On 5... Read more
On 5/5/2021 pt says the left side of her body became very sore from her shoulder to her elbow. On 5/10/21 she developed an x-shaped rash around her left arm pit and left breast. The lymph nodes are swollen under the left armpit. On 5/11/21 pt went to Dr. and was diagnosed w/ Shingles and prescribed Valtrex. She was told to take Ibuprofen for the pain.
51 2021-05-13 lymph node swelling Swollen, sore lymph node in left armpit
51 2021-05-13 swelling face, swelling About 30 minutes after getting the first shot of Pfizer vaccines, the left side of my body started t... Read more
About 30 minutes after getting the first shot of Pfizer vaccines, the left side of my body started to feel like getting swollen. Left half of my face started feeling swollen and tingling - like when your dental anesthesia was wearing off, and my left arm feeling swollen. I checked my left hand and my face on the mirror to see if they were really swollen, but they looked normal. I think it was more of the neurological effect. I can't remember if my left leg was also impacted. I think about 30 minutes or so, it started get better so I didn't go to see a doctor. About an hour after the shot, I think it was pretty much gone. Now, I may be too self conscious, but I feel like something wrong /weird with the left side of my body/face, but that may be my anxiety tricking me.
51 2021-05-14 swelling face Swelling in the face, hives and rash.
51 2021-05-15 peripheral swelling Later that evening after receiving my 2nd dose I began to experience mild joint pain. From the nex... Read more
Later that evening after receiving my 2nd dose I began to experience mild joint pain. From the next morning up to today?s date I am still experiencing abnormal joint pains and swelling in my knees, ankles and feet. Currently, on my right foot my 4 smaller toes and the upper part of my foot I?m having pain that is causing me not to be able to put all of my weight on it. I?ve had days where I could hardly get out of bed and honestly, just exhausted. I contacted my rheumatologist and was advised to just double up on my steroids. At this point I?m not sure there?s anything else to do, but to ride it out. I just felt that I should report it so that there could be considerations with regard to those who have lupus and mixed connective tissue disease. It truly has made my joint issues amplified.
51 2021-05-16 lymph node swelling swollen lymph node on left side of neck
51 2021-05-17 anaphylactic reaction Anaphylaxis occurred approximately 37 minutes after the vaccine
51 2021-05-18 peripheral swelling After first dose the next evening muscle and joint pain in left wrist, left lower arm and left hand.... Read more
After first dose the next evening muscle and joint pain in left wrist, left lower arm and left hand. Swelling in left wrist and hand difficult to close hand. Stinging pain in left wrist, left lower arm and left wrist. Stinging pain still comes and goes in left lower arm, wrist and hand. Pain and swelling has improved. Second dose in right arm was normal with no adverse reactions.
51 2021-05-18 swelling, swelling face Feeling a little dizzy here and there, so I am worried/ intermittent mild dizziness; Swelling in sof... Read more
Feeling a little dizzy here and there, so I am worried/ intermittent mild dizziness; Swelling in soft palate and uvula/Soft palate tingling then swelling including uvula (area tender from swelling); Having flare up with my rosacea/Redness on rosacea area; Soft palate tingling then swelling including uvula (area tender from swelling); Soft palate tingling then swelling including uvula (area tender from swelling); Soft palate tingling then swelling including uvula (area tender from swelling); Mild swelling around nose, eyes and lips (areas feel tight sort of burn); mild swelling around nose, eyes and lips (areas feel tight sort of burn); mild swelling around nose, eyes and lips (areas feel tight sort of burn); mild swelling around nose, eyes and lips (areas feel tight sort of burn); Swelling in my face and throat; Tingling; Swelling in my face and throat; Redness of rosacea really pop-up red and then my lips were just slight little swollen around my nose and around my eyes; Redness of rosacea really pop-up red and then my lips were just slight little swollen around my nose and around my eyes; This is a spontaneous report from a contactable consumer (Patient). A 51-years-old female patient non-pregnant received 1st dose of BNT162B2, (Pfizer covid-19 vaccine Formulation: Solution for injection, Lot number: EN6207) via an unspecified route of administration, administered in arm left on 13Mar2021 09:45 as 1st dose, single for covid-19 immunisation. Medical history included allergy, insulin resistance, food intolerance, yeast, rice, spaghetti squash, hybrid pumpkin, yogurt, asthma, Thyroid and Hypermobility in joints. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) for Allergy; levothyroxine for thyroid; vilazodone hydrochloride (VIIBRYD); phentermine hydrochloride, topiramate (QSYMIA) and allergy Shot. No other vaccine was received in four weeks. Known allergies are Amoxcillin, Bactrim DS, yeast, rice, spaghetti squash, hybrid pumpkin, Betadine alcoolico, Metrogel, yogurt. Other medical history includes Allergies, asthma in remission, adverse reactions to Welbutrin, Contrave, Oxcarzepazine, Victoza. Patient had surgeries. Patient had blood drawn to check calcium level but don't know if that was within the last 2 weeks. On 13Mar2021 patient stated that I had my first Covid vaccination yesterday (13Mar2021) and I did report "Online" (further not clarified, hence captured as initial report) because I did have some swelling in my face and throat and there was sometimes that I was feeling a little dizzy here and there, so what I am worried about is, if I am going to not have the next vaccination because I am scared of the disease too. That's why I called. When paraphrased the concern, consumer stated, Yes and now the swelling that I had was on my soft palate and my uvula. It started tingling and then I did have some swelling there and on my face, I have rosacea and, so was having the flare up with my rosacea anyway, and that made all the areas that I had the redness of rosacea really pop-up red and then my lips were just slightly swollen and it was a little swollen around my nose and around my eyes and the dizziness it was just here and there, it was not anything big but this is a kind of reaction that I have, the thing the soft palate of my throat I have had that before when I had eaten eat something yeast and something like that, so I do not know is the shot may be have yeast so but I have not had that kind of slight swelling there on my face before, that's what I called. When probed for other Medical condition, consumer stated, I actually have allergies, they were pretty bizarre (not clarified) and Allergist calls me his special patient and I have food intolerances, so that's, the things right they are a lot of them. The thing that has calls me the most trouble is yeast. It does not matter if it is baker's yeast or brewer's yeast or yeast extract and I have unusual one like spaghetti squash and hybrid pumpkin, the spaghetti squash was the pumpkin and having that spaghetti squash in the hybrid pumpkin mainly react to it. In response to other medical condition, consumer stated, "There are other medication, I do have some other health conditions, I have Hypermobility in my joints, and I have a lot of "weird" (not clarified) things that I had like surgeries for different thing too but the main, and I am considered insulin resistance and I have had reactive low blood sugar at a time. Shot at 09:45 on 13Mar2021, experienced Soft palate tingling then swelling including uvula (area tender from swelling), mild swelling around nose, eyes and lips (areas feel tight sort of burn), intermittent mild dizziness. Redness on rosacea area. Benadryl -1 at 10:30, 1 at 11am, 2 at 2:41pm experienced headache (pain, pressure) at 01:45, Advil -1 at 07:45 experienced face flushed/hot feeling. Benadryl was self-administered as treatment. No covid prior vaccination and the patient was not tested for covid tested post vaccination. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.
51 2021-05-18 swelling Swelling
51 2021-05-19 lymph node swelling Nausea; Soreness at the injection site; Dizziness; Headache; Lymphadenopathy under the arm andon nec... Read more
Nausea; Soreness at the injection site; Dizziness; Headache; Lymphadenopathy under the arm andon neck near collar bone (on the rightside); This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3247), via an unspecified route of administration in the right arm on 15Mar2021 02:00 PM (at the age of 51-years-old) as a single dose for COVID-19 vaccination. Medical history included penicillin allergy. The patient did not have any allergies to food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient past drug history included BNT162B2 (BNT162B2 Lot/batch no: EL3247), dose number 1 via an unspecified route of administration in the right arm on 22Feb2021 at 02:00 PM as single dose for COVID-19 immunization. On 16Mar2021 at 02:00 AM, the patient experienced Headache, Nausea, Dizziness, Soreness at the injection site, Lymphadenopathy under the arm and on neck near collar bone (on the right side). No therapeutic measures were taken for the event. The clinical outcome of the event Headache, Nausea, Dizziness, Soreness at the injection site, Lymphadenopathy was recovering at the time of the report. No follow-up attempts are needed. No further information is expected.
51 2021-05-19 lymph node swelling swollen lymph node in my left armpit the size of a grapefruit; chills; nausea; headache; fever; swea... Read more
swollen lymph node in my left armpit the size of a grapefruit; chills; nausea; headache; fever; sweating; burning/tingling in my entire arm,; fatigue; aches; burning/tingling in my entire arm,; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29Apr2021 (Batch/Lot Number: EW 0175) (at the age of 51 years old) as 1st dose, single for COVID-19 immunisation. Medical history included migraines from an unknown date and unknown if ongoing, and COVID in Mar2020 (including long haul effects such as loss of smell for 6 months and losing handfuls of hair). The patient's concomitant medications were not reported. It was reported that patient had COVID in Mar2020. She tested positive for antibodies in Apr2020. Upon receiving the first dose this past week, she ended up reacting just like she had COVID all over again. Within 4 hours she had chills, nausea, headache, fever, sweating, burning/tingling in my entire arm, aches, fatigue, etc, then she developed a swollen lymph node in the left armpit the size of a grapefruit. Acute symptoms persisted for 5 days (she was in bed the whole time) and she still have the swollen lymph node. She expected some symptoms for the second shot, but not the first. She was now very concerned about getting the second dose, especially since she read studies showing she could have as much protection after one shot since she had COVID as people who didn't have COVID. Additionally, she was a smaller woman and feel like maybe the dosage was too high. She was very healthy with no comorbidities except she had COVID previously (including long haul effects such as loss of smell for 6 months and losing handfuls of hair). The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient diagnosed with COVID-19. The patient has been tested for COVID-19 since the vaccination. PCR (Nasal swab) was done on 03May2021 with negative result. The outcome of events was recovering.
51 2021-05-20 swelling CLIENT VACCINATED ON TUESDAY. ON WEDNESDAY CLIENT NOTICED SOME SLIGHT NUMBNESS IN THE LEFT ARM, ARMP... Read more
CLIENT VACCINATED ON TUESDAY. ON WEDNESDAY CLIENT NOTICED SOME SLIGHT NUMBNESS IN THE LEFT ARM, ARMPIT AREA, SIDE OF THE BREAST. ON THURSDAY MORNING CLIENT REPORTS "VERY NUMB", SLIGHTLY PAINFUL AND TENDER. NO CHANGE IN PHYSICAL APPEARANCE BUT DOES FEELS SWOLLEN BY THE TOUCH. LEFT HAND WAS SWOLLEN IN JOINTS, AND WAS TENDER. CLIENTS REPORTS SOME ARTHRITIS. IMPROVEMENT OF ARM THE NEXT DAY. CLIENT WILL SEEK MEDICAL ADVICE IF SYMPTOMS WORSEN OR DO NOT IMPROVE. RECOMMENDED TO SPEAK WITH ONCOLOGIST TO SEE IF OTHER CLIENTS WITH BREAST CANCER AND HX OF DOUBLE MASTECTOMY HAVE NOTICED ANY REPORTS IN OTHER PATIENTS.
51 2021-05-21 swelling face, swelling Flu like symptoms, light headed, clogged ears, swollen neck and face, sore eyes, sore throat (first ... Read more
Flu like symptoms, light headed, clogged ears, swollen neck and face, sore eyes, sore throat (first day) , feeling spacey
51 2021-05-22 oral herpes I had my jaw rewired 20 years ago. The jaw, teeth started to hurt about a week after first dose. ... Read more
I had my jaw rewired 20 years ago. The jaw, teeth started to hurt about a week after first dose. Then 3 days after second dose, I got a big cold sore with several clusters. I NEVER get cold sore in warm months. If I do get one, it?s in the winter and just a small one. I use abreva at the first sign, and it goes away next day. But this cold sore, it is going the full blown 2 week recovery despite abreva. One week after my second dose, I got skin rash on my face cheeks, kinda like rosacea. I never had this before. All symptoms are still as of May 23.
51 2021-05-23 anaphylactic reaction, swelling face Patient got the Pfizer vaccine on 5/22 at about 4:30pm. She did not have an immediate reaction. Th... Read more
Patient got the Pfizer vaccine on 5/22 at about 4:30pm. She did not have an immediate reaction. The next morning she noticed some swelling in the face and it progressed to the jaw and then started to feel throat tightness at which point she went to the urgent care with an anaphylactic reaction. They gave her a steroid injection.
51 2021-05-24 pancreatitis Patient presented to the ED on 4/9/21 and diagnosed with diverticulitis. Patient presented to the ED... Read more
Patient presented to the ED on 4/9/21 and diagnosed with diverticulitis. Patient presented to the ED and was subsequently hospitalized on 4/20/21 with pancreatitis. These visits were within 6 weeks of receiving COVID vaccination.
51 2021-05-24 peripheral swelling Systemic: swelling in both feet, burning sensation in both feet-Medium, Systemic: Tingling (specify:... Read more
Systemic: swelling in both feet, burning sensation in both feet-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: patient reported that 48 hours following first dose she experienced swelling in both feet and a burning sensation in both feet. These symptoms have persisted for greater than 24 hours and have not subsided when reported at 4:42 pm 5/24/21
51 2021-05-25 peripheral swelling, lymph node swelling, lymph node pain Right arm swelled up within 5 minutes after shot, hard to move fingers with the swelling. Tingling,... Read more
Right arm swelled up within 5 minutes after shot, hard to move fingers with the swelling. Tingling, numbness. Next day intense pain at injection site, but swelling had gone down. Trouble sleeping first 3 nights after vaccine. Pain at injection site lasted until 4 days later when right shoulder joint began to hurt causing limited mobility. 7 days after vaccine lymph nodes very swollen and tender in left armpit and large swollen nodule next to right ear on scalp appeared. 9 days after vaccine still having pain and mobility issues with right shoulder. Have been generally fatigued, harder to exercise in the days after the vaccine.
51 2021-05-29 lymph node swelling Between 24-48 hours began have reactions not expected. Pain in LEFT foot and toes. Severe pain in LE... Read more
Between 24-48 hours began have reactions not expected. Pain in LEFT foot and toes. Severe pain in LEFT hand, fingers, wrist, and forearm. Then pain in BOTH wrists, hands, feet, and then lower back pain. The pain moved from scary levels to dull pain over the 2 weeks post-vaccination. I expect the pain will go away soon. The use of my hands was affected. Walking was affected. It felt like the lymph nodes around my ears, neck, face, eyes, chest, arms, abdomen, legs were all swollen. Can swollen lymph cause carpal tunnel like symptoms? Foot pain? Lower back pain? Began to have allergic like skin reactions 5 days post-vaccination. Burning eyes, itchy skin. Still experiencing itchy skin with red/warm face 13 days post-vaccine. Antihistamine relieves most symptoms. This vaccine does not seem sustainable for me as a yearly vaccine. (I had red palms after the 1st vaccine within hours. I am not sure if this was a reaction to the vaccine. I began taking antihistamine before the 2nd vaccine and did not get red palms. I have no idea if red palms were an early hint that I would be hyper sensitive to the vaccine.)
51 2021-06-01 swelling face Swelling of my tongue and face. Could still breath so didn't go to emergency room. Fully went away a... Read more
Swelling of my tongue and face. Could still breath so didn't go to emergency room. Fully went away after about 4 hours. Left arm could barely lift through the next day. Achy sinuses feeling through the next day.
51 2021-06-02 lymph node pain Sore and tender lymph nodes in left armpit; This is a spontaneous from a contactable consumer (patie... Read more
Sore and tender lymph nodes in left armpit; This is a spontaneous from a contactable consumer (patient). A non-pregnant 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6200), via an unspecified route of administration in left arm, on 22Feb2021 at 09:00 AM (at the age of 51 years), as single dose, for COVID-19 immunization. The patient had no medical history and no known allergies. The patient's concomitant medication included colecalciferol (VITAMIN D). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. On 01Mar2021 at 02:00 AM, the patient experienced sore and tender lymph nodes in left armpit. No treatment was administered for the adverse event. The patient had not been tested for COVID-19 post vaccination. The patient had not recovered from the event. No follow up attempts are possible. No further information is expected.
51 2021-06-03 lymph node swelling swollen lymph node in RT side of the neck; extreme discomfort; producing an earache; sore neck/shoul... Read more
swollen lymph node in RT side of the neck; extreme discomfort; producing an earache; sore neck/shoulder x 3 days which began the day after the injection; sore neck/shoulder x 3 days which began the day after the injection; This is a spontaneous report from a contactable other hcp (patient). A 51-years-old (non-pregnant) female patient received BNT162B2 (BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6205, expiration date unspecified), dose 1 intramuscularly, administered in Arm Left on 04Mar2021 11:30 (at the age of 51-years-old) as SINGLE DOSE for covid-19 immunization at School or Student Health Clinic. The patient was not pregnant at the time of vaccination. Medical history included fibromyalgia, migraine, attention deficit hyperactivity disorder, drug hypersensitivity (sulfa allergy) with supplementation therapy from an unknown date. Concomitant medications included pregabalin (LYRICA), naproxen (NAPROXEN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), cetirizine hydrochloride (CETRIZINE), vitamin b complex (VIT B COMPLEX), calcium (CALCIUM) tizanidine (TIZANIDINE); quetiapine fumarate (SEROQUEL) was taken for an unknown indication from an unknown start date at an unknown dose and magnesium (MAGNESIUM) taken for supplementation therapy, from unknown start date. The patient had not covid prior vaccination. The patient did not have any other vaccine in the past four weeks. On 05Mar2021 08:00AM, the patient experienced swollen lymph node in RT side of the neck, extreme discomfort, producing an earache and sore neck/shoulder for 3 days which began the day after the injection. The patient did not receive any treatment for events. The patient was not tested for covid post vaccination. The outcome of the events was reported as recovering at the time of report. No follow-up attempts are possible. No further information is expected.
51 2021-06-03 peripheral swelling States her cholesterol is always 75 and is now 200; facial droop or pain in her face; noticed her ar... Read more
States her cholesterol is always 75 and is now 200; facial droop or pain in her face; noticed her arms started getting numb and swelling up; noticed her arms started getting numb and swelling up; facial droop or pain in her face; talk with the slur; tingling in her fingers; ended up in the emergency room and had a stroke; she had blood clots on the brain from the stroke; she went into the ER her blood pressure was 200/180; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 51-year-old female patient received bnt162b2 (Lot Number: ER8730; Expiration Date: 31Jul2021), second dose via an unspecified route of administration, administered in left arm on 11Apr2021 (early in the morning) at the age of 51-year-old as 2nd dose, single for covid-19 immunization. Medical history included ventricular septal defect from an unknown date and unknown if ongoing (she was born with a hole in her heart but that had closed up and when she had the stroke, the hole opened back up and they told her she had blood clots on the brain from the stroke). There were no concomitant medications. The patient previous received first dose of bnt162b2 (Batch/Lot Number: ER2613; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in left arm on 21Mar2021 single dose for covid-19 immunization. The patient experienced stroke on 20Apr2021, she had blood clots on the brain from the stroke on 20Apr2021, blood pressure was 200/180 on 20Apr2021, her cholesterol is always 75 and is now 200 on an unspecified date, facial droop on an unspecified date, her arms started getting numb and swelling up on an unspecified date, pain in her face on an unspecified date, talk with the slur/ slurred speech on an unspecified date. The events her arms started getting numb and swelling up, pain in her face and talk with the slur/ slurred speech were serious per hospitalization; stroke, she had blood clots on the brain from the stroke, blood pressure was 200/180, her cholesterol is always 75 and is now 200 and facial droop were serious per hospitalization, medically significant. The patient was hospitalized for from 20Apr2021 to an unknown date. The events require a visit to emergency room and physician office. Caller states she is calling about the Pfizer shot and had the 2nd dose on 11Apr2021 and noticed her arms started getting numb and swelling up and she did not do anything about it but 2 days after that she called the facility where she had the Pfizer shot and they said to call her HCP and the HCP was out of town so she spoke with a nurse and was told to go to urgent care at that time. States she went to urgent care and they said her arm was swollen and to rub alcohol on it and she did that and a couple of days after that ended up in the emergency room and had a stroke. States the numbness and swelling was just the whole left side of her body and she went to the emergency room at the hospital on 20Apr2021 but on 16Apr2021 she went to the urgent care; states the numbness and swelling is better but comes and goes with the tingling in her fingers and the numbness, but her face is doing much better and she does not have the facial droop or pain in her face anymore; states her speech is back and she does not talk with the slur anymore. States the facial droop, face pain and slurred speech began when she went to the ER and that was on 20Apr2021 and is now completely resolved. Caller states the 1st dose of her Pfizer Vaccine was administered on 21Mar2021 with lot ER2613, the 2nd dose was administered on 11Apr2021 with lot ER8730; states both doses of the Pfizer Vaccine were administered in her left arm and her patient card does not have the NDC written on it but the expiry date for both doses of the vaccine is 31Jul2021. States the whole year of 2020 she was doing fine till she took the Pfizer Vaccine and that shot everything up regarding her cholesterol levels and Blood pressure which are all high; states her cholesterol is always 75 and is now 200; states she has high blood pressure and when she went into the ER her blood pressure was 200/180; states she was born with a hole in her heart but that had closed up and when she had the stroke, the hole opened back up and they told her she had blood clots on the brain from the stroke. The patient underwent lab tests and procedures which included cholesterol: 200 on 10May2021 (her cholesterol is always 75 and is now 200), blood pressure: 200/180 on 20Apr2021. The outcome of events for stroke, she had blood clots on the brain from the stroke, her blood pressure was 200/180, her cholesterol is always 75 and is now 200, tingling in her fingers were unknown, for other events was resolved on an unspecified date. Vaccination Facility Type: school. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks).
51 2021-06-05 peripheral swelling Big Swelling and not going down since injection for my second shot and is painful sometimes Has not... Read more
Big Swelling and not going down since injection for my second shot and is painful sometimes Has not sort treatment but sometimes take pain medication (Aleve)
51 2021-06-06 lymph node swelling At time of injection I got an instant headache. Next day felt odd, headache still there, injection ... Read more
At time of injection I got an instant headache. Next day felt odd, headache still there, injection site very sore, noticed extremely puffy lymph nodes in left armpit. Took Tylenol 500mg, no help. That night armpit more puffy and noticed lymph?s in left side of neck were puffy, still had headache. Could not sleep on left side because of pressure of body on arm. Next day still had headache and even more puffy lymph?s in arm and sore, took 600mg ibuprofen, eased headache, took 1000mg Vita C. Later took another 600mg ibuprofen, headache went away. Overnight still too puffy and sore to sleep on that side. Next day took 1000mg Vita C, 600mg ibuprofen. Went to work, noticed in the afternoon that the puffy swelling had reduced a little and not tender in the armpit, Neck still the same.
51 2021-06-06 swollen extremities, swelling, peripheral swelling, lymph node swelling I had the vaccine and after 3 hours I was exhausted, I was confused, couldn't think through, fever, ... Read more
I had the vaccine and after 3 hours I was exhausted, I was confused, couldn't think through, fever, swelling on my arm. I slept all night long until the next day and I had like flu like symptoms. In that period my husband tried to woke me up and I would eat something but it felt like I was in a dream, I felt like a zombie. For about a week after I was sick but not sick to not go to work . I had swelling on my neck, clavicle, and armpit, they were obviously lymph nodes. I was thinking about cancer because my dad died of Cancer. I made an appt with a doctor for a cancer check instead of going for the covid. Which after about 15000 tests I am cancer free. I found out that those symptoms could actually be part of the vaccine. They took a good look at it and order some tests and they said it was a reaction to an infection and I told them I had just had the vaccine and they did some tests and they said it was most likely the vaccine. After 2 weeks the lymph nodes started to go down. After the second shot I had the same symptoms but not as intense.
51 2021-06-07 axillary mass get two bumps under each arm pit but they went away a couple days late; fever; This is a spontaneous... Read more
get two bumps under each arm pit but they went away a couple days late; fever; This is a spontaneous report from a contactable consumer (patient herself). A 51-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247; Expiry date: unknown) via an unspecified route of administration on 22Feb2021 as single dose for COVID-19 immunization. Medical history included mammary duct ectasia from 1999 to an unknown date. Patient had not received any other products. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on 01Feb2021 for COVID-19 immunization. The patient's concomitant medications were not reported. Caller stated that she was calling to report not an adverse event, just the opposite, wanted to report an additional benefit to the Pfizer COVID vaccine, caller was a Pfizer employee, stated she also wanted to report that after she had her oldest daughter in 1999 she had a clogged breast duct under her right arm pit, and there has been a bump that comes and goes with her period under her right arm pit since then, saw a doctor many years ago and did so many tests, CT and ultrasounds, they were not concerned. Caller stated she had the first dose of the Pfizer COVID vaccine on 01Feb2021, then second dose was on 22Feb2021, stated she was not really paying any attention. She saw that article and then looking at her past three periods the bump did not bother her, it had not been an issue since the doses of the vaccine. Caller stated after the second dose, on Feb2021 she did experience a fever the whole next day, states she did initially get two bumps under each arm pit but they went away a couple days later, exact dates was unknown. Reporter seriousness for bump under right arm pit has disappeared and not bothered her was unspecified. The outcome of events was recovered on Feb2021.
51 2021-06-07 peripheral swelling, swelling face Patient's upper extremities and face swelled up. Eyes were also swollen shut. Injection site on left... Read more
Patient's upper extremities and face swelled up. Eyes were also swollen shut. Injection site on left arm was the size of a half dollar coin.
51 2021-06-07 peripheral swelling Pneumonia; congestion in one side of her head or in the upper front side, similar like a sinus infec... Read more
Pneumonia; congestion in one side of her head or in the upper front side, similar like a sinus infection; She had her ears going plugged, she had a bloody flavor and blood was coming little portion of her coughing; arm swollen; Rash; lot of stuffy nose; really bad runny nose; she can't breathe to sleep; ears going plugged; she had a bloody flavor and blood was coming little portion of her coughing; bronchitis symptoms; congestion in one side of my head or in the upper front side, similar like a sinus infection; This is a spontaneous report from two contactable consumers (patient and patient's husband). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose via an unspecified route of administration, administered in right arm on 17May2021 (Batch/Lot number was not reported) (at age 51 years old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date at age 51 years old for COVID-19 immunization. The patient reported she had the second shot for the vaccine (confirmed as Pfizer COVID vaccine) on 17May2021 almost at midnight and she had been really sick since Wednesday. She clarified that it was really bad from Monday (17May2021) but on the Tuesday (18May2021) she has her arm swollen and the rash but she thought it was normal and then from the 17May2021 up to the time of report she has been really, really sick, like bronchitis symptoms something like that and she had a lot of stuffy nose and she had congestion in one side of her head or in the upper front side, similar like a sinus infection. She had her ears going plugged, she had a bloody flavor and blood was coming little portion of her coughing, really bad runny nose and she can't breathe to sleep, she had to use (incomplete sentence). The patient's husband stated she got no treatment she did not go to the doctor. They wanted to know if she can take cold medicine because she was up with pneumonia. Outcome of the events was unknown. Information about lot/batch number has been requested.
51 2021-06-08 c-reactive protein increased After my Pfizer vaccine I experienced a low grade temperature, bilateral leg and bone pain, insomnia... Read more
After my Pfizer vaccine I experienced a low grade temperature, bilateral leg and bone pain, insomnia , hot flashes, night sweats, fatigue for 3 weeks, chronic cough, fatigue 3 weeks in duration, diarrhea, stomach pain, air hunger., anxiety. body pain. joint pain have gotten worst since vaccination.
51 2021-06-08 peripheral swelling, lymph node swelling Enlarge lymph node on the left neck area underneath the collarbone. Left arm had a tingling sensati... Read more
Enlarge lymph node on the left neck area underneath the collarbone. Left arm had a tingling sensation. Unable to walk on left foot due to swelling.
51 2021-06-08 peripheral swelling Two weeks after the vaccination, I saw a bump on my hand. When i am looking at the back of my hand,... Read more
Two weeks after the vaccination, I saw a bump on my hand. When i am looking at the back of my hand, my thumb, you could see my vein, my vein was a dark, greenish purple and usually I can't see my veins, I saw a little bump on my vein, the size of a lentil pea. The doctor asked if I had bumped it, but I had not bumped my hand. It began getting bigger, it went from the size of a lentil bean to the size of a quarter and changed color, it looked like it had clear or white fluid in it. The doctor said it was a firm mass and removed it to see if it wasn't cancer. The doctor said it was non-cancerous.
51 2021-06-08 peripheral swelling Within an hour of getting the vaccine, started to hurt on her right arm and then spread to her back,... Read more
Within an hour of getting the vaccine, started to hurt on her right arm and then spread to her back, swelling then started increased to softball size in rt arm. Area hard and hot. Later that night she had problems with nausea, tylenol was taken for pain. The symptoms lasted longer than a week, "I was in bed for a week, the pain in the arm lasted longer than that."
51 2021-06-08 swelling face, swelling Follicular Eczema; very bad rash/started on her face then spread to neck, arm, back, inner thighs an... Read more
Follicular Eczema; very bad rash/started on her face then spread to neck, arm, back, inner thighs and behind her knees and slowly spread on her body/Rash was also on shoulder; swelling; rash was inflamed and red; rash was inflamed and red; infection in her nostril/nostril infection, redness; infection in her nostril/nostril infection, redness; nose reaction which looked yellowish; Swelling and red was on the face; the yellow discharge on the side of her lip; in left thigh; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left thigh on 26Apr2021 at 08:20 (at the age of 51 years old; Lot Number: EW0176, unknown expiration) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient also received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via injection in left thigh on unspecified date (Lot Number: ER2613, unknown expiration) for COVID-19 immunization at the age of 51 years old. On 26Apr2021 at 08:20, the patient received her second dose of Pfizer COVID vaccine. On 27Apr2021, the patient developed a very bad rash in the late afternoon that is ongoing and is getting worse every day and not better. It started on her face then spread to neck, arm, back, inner thighs and behind her knees and slowly spread on her body. The rash kept adding body parts. Rash was also on shoulder. The patient talked about swelling, but not sure where it was and if it was related to rash. The rash was inflamed and red. The patient also has infection in her nostril/nostril infection, redness. Infection started at same time as rash. The patient sought medical help from two doctors and was treated with ointments and medications including Benadryl and a completed course of antibiotics. Antibiotics helped with the infection. The swelling went down. The patient clarified that she was given antibiotic for nose reaction which looked yellowish. Then it moved onto her face around her lip under her nose. Swelling and red was on the face. She did not have a fever. Dermatologist gave her ointment and she started another antibiotic for 1 day and then stopped because she was getting other side effects. She continued on the antibiotic ointment for around the lip because she was forming the same infection as 4 weeks ago. She is getting back to square zero. She said the ointment for her face and skin took away the yellow discharge on the side of her lip. She reported that the rash was increasing. She stated that other things were getting temporary relief from the antibiotic, the infection, but then it kept coming back. The infection was better with the ointment, but she is not sure if will stay better. The patient was asking for recommendations on how to manage as her doctors did not know how to treat. The patient was referred back to her doctor and was told that her doctor could call Pfizer or the CDC. Upon investigation on 14May2021, biopsy of left wrist was given name dermatitis involving hair follicle, Follicular Eczema. That was what doctor's best guess. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
51 2021-06-08 swelling covid arm; rash on right arm at site if injection. Itchy; swelling; persists still
51 2021-06-08 swelling tingling in finger tips; pain; swelling; fever; chills; tiredness; This is a spontaneous report from... Read more
tingling in finger tips; pain; swelling; fever; chills; tiredness; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 09Mar2021 at 10:00 (Batch/Lot Number: EL3247) (at the age of 51-years-old) as first dose, single dose for COVID-19 immunisation. Medical history included high blood pressure and Covid-19 prior to vaccination. Concomitant medications included amlodipine and carvedilol; both taken for an unspecified indication, start and stop date were not reported. On 10Mar2021 at 08:00, patient experienced tingling in finger tips, pain, swelling, fever, chills, tiredness. Patient did not received any treatment for the events. Patient had not tested for Covid post vaccination. Outcome of the events was recovering. No follow-up attempts needed. No further information expected.
51 2021-06-08 white blood cell count increased On January I had some blood tests done and my set rate was 111, white blood count 9.6, red blood cou... Read more
On January I had some blood tests done and my set rate was 111, white blood count 9.6, red blood count 4.01, hemoglobin 13.9, hemacrit 40.2 On 03/22/2021 after having the first dose my set rate 128, white blood count 12.1, red blood count 3.67 which is low, hemoglobin 12.9, and my hemacrit 36.1, platelets 153 On 05/06/2021 after having the second dose my set rate 122, white blood count 14.3, red blood count 3.63 which is low, hemoglobin 12.6, hemacrit 35.2, platelets 624. I still have stomach problems sometimes.
51 2021-06-09 swelling face Right side of face cheekbone area swelled (NO fillers!!), went numb to the touch but deeply painful... Read more
Right side of face cheekbone area swelled (NO fillers!!), went numb to the touch but deeply painful for the next 5/6 days
51 2021-06-12 peripheral swelling Patient called pharmacy on 06/13/2021 01:20 P.M.. She complained of swelling from her left knee to h... Read more
Patient called pharmacy on 06/13/2021 01:20 P.M.. She complained of swelling from her left knee to her toe since getting her first dose of the Pfizer vaccine on 06/11/2021 in her right arm. Her arms were not swollen. Just her left leg. Swelling started the night of 06/11/2021 and has not improved since then. She said she hadn't done any walking or any other movement that would cause this swelling. I told her to try putting on cold compresses and taking allergy medication to help with the swelling, and if it doesn't improve, to go see a doctor.
51 2021-06-13 swelling, peripheral swelling The day after the second vaccine I got bodyaches and a headache. The next day I had pain in my hands... Read more
The day after the second vaccine I got bodyaches and a headache. The next day I had pain in my hands and feet and they felt like they were swollen, but I had no swelling. Over the next week the sensation of swelling continued in my hands and feet and I have severe joint pain and mild swelling in my lower extremities. I have not felt well since.
51 2021-06-14 lymph node swelling, lymph node pain First dose January 6 2021, only pain in the arm. Second dose January 28, 2021, day after the shot,... Read more
First dose January 6 2021, only pain in the arm. Second dose January 28, 2021, day after the shot, had to leave work, chills, nausea, extreme weakness, joint pain, muscle pain. By the end of the day and continuing into the next two days, joint and muscle pain, hard painful swollen lymph nodes in armpits, neck, collarbone area, behind knees, inguinal area. Couch bound for 3 solid days. Swollen nodes lasted approx 1 week. Weakness persisted into week #2, about 10 days. Weight loss. Random bloodwork drawn for a physical on February 20, 2021 - fasting blood glucose was 407. Last two blood glucose levels, 2017 and 2019 were both 108. March 6, 2021 fasting glucose 347, HgbA1C 13.8%. March 15, 2021 fasting blood glucose 240, HgbA1C 10%. Joint pain persists. Started on Metformin 500mg po bid March 18, 2021. BGMs range from 475+ to 361 until March 30, 2021. April BGMs range 326-coming down to 209 and 198. Metformin increased May 24, 2021 to 1000mg po bid. bgms starting May 24, 2021 at 156, have come down to high 120s. Weight December 8, 2020 was 198. Weight loss of around 30 lbs, weight currently today 174.
51 2021-06-15 lymph node swelling I was incredibly tired the netxt day I couldn't get out the bed. On Monday or Tuesday I got a really... Read more
I was incredibly tired the netxt day I couldn't get out the bed. On Monday or Tuesday I got a really bad headache. Every time I moved my head it would hurt. I raised my left arm and my lymph nodes were swolen. I went to the doctor and was told to wait it out.
51 2021-06-15 lymph node swelling swollen lymph node under left arm associated with soreness; This is a spontaneous report from a cont... Read more
swollen lymph node under left arm associated with soreness; This is a spontaneous report from a contactable consumer reporting for herself. A 51-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 11Mar2021 14:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation . The patient medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; fluconazole (FLUCONAZOLE) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, cyanocobalamin, nicotinamide, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (T-VITES) taken for an unspecified indication, start and stop date were not reported. The patient experienced lymphadenopathy on 13Mar2021 10:30 with outcome of not recovered. Course of the event On second morning after second dose, I woke up with swollen lymph node under left arm, vaccination was also given in my left arm. It looks fatty/ swollen and has soreness/ pain associated with it. No follow-up attempts are possible; information about lot/batch number cannot been obtained
51 2021-06-15 lymph node swelling Feels like swollen lymph nodes:Right armpit Behind both ears Right side of neck; This is a spontaneo... Read more
Feels like swollen lymph nodes:Right armpit Behind both ears Right side of neck; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration, administered in left arm on 25Feb2021 at 11:30 AM (at the age of 51 years old) at first dose, single dose for COVID-19 immunisation. The patient has no relevant medical history and has no known allergies. The patient was not pregnant at the time of vaccination. The patient was taking unspecified medications in two weeks within vaccination. The patient reported that she felt like having swollen lymph nodes: right armpit, behind both ears, and at the right side of neck on 11Mar2021 at 09:00 PM. The patient has no COVID-19 prior to vaccination and was not COVID tested post vaccination. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
51 2021-06-15 oral herpes A huge fever blister appeared on day 2 after vaccine. I haven't had one in; This is a spontaneous re... Read more
A huge fever blister appeared on day 2 after vaccine. I haven't had one in; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in left arm on 05Feb2021 12:30 PM as 1st dose single for an unspecified indication. Medical history included hypertension, obesity, drug hypersensitivity and known allergies: Penicillin. Concomitant medications included Zoloft (sertraline hydrochloride), taken for an unspecified indication, vitamin C taken for an unspecified indication, vitamin D (colecalciferol) taken for an unspecified indication. The patient not had covid prior vaccination and post vaccination. On 07Feb2021 07:00AM, The patient experienced ‘A huge fever blister appeared on day 2 after vaccine. Patient stated she haven't had one in years and this one was bigger than ever. Treatment was not reported. The outcome of the event was not recovered. Follow-up (13May2021): Follow-up attempts completed. No further information expected
51 2021-06-16 swelling face Heart since beating really very fast; I can't even walk; Feel really drunk; Also numbness I guess my... Read more
Heart since beating really very fast; I can't even walk; Feel really drunk; Also numbness I guess my face; 'Swollen' face; Don't feel good; Dizzy; I am weak, if you look into my eyes I look I am really sick; I am tired; Headache; Sick; can not even speak; This is a spontaneous report received from a contactable consumer (Patient) or other non HCP. A 51-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0181, Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 12Jun2021 11:00 (at the age of 51-years-old) as first dose single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. On 12Jun2021, the patient experienced heart since beating really very fast, cannot even speak, feel really drunk, also numbness in face, swollen face, don't feel good, dizzy, weak, tired, headache, sick and can't even walk. Patient had some side effects from the shot today. Got the first dose this morning, since then her heart beating really very fast throughout the day, she actually felt really drunk, she cannot even speak to you, cannot even walk, she was out of it. Consumer stated, that was not worrying, she did not feel good, she did not really feel very good (voice not clear). She was tired, had a headache, her face was like either swollen or numb, she was dizzy, she was weak, she told that if someone look into her eyes, she looked like she was really sick, she can hardly even walk, felt like she drunk. The patient underwent lab tests and procedures which included heart rate: fast on 12Jun2021.The outcome of events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
51 2021-06-18 lymph node swelling Pain radiating to my back; Night sweats; Severely swollen Lymph Nodes with pain radiating to my back... Read more
Pain radiating to my back; Night sweats; Severely swollen Lymph Nodes with pain radiating to my back.; Severe chills; probably fever; This is a spontaneous report from a contactable patient. A 51-year-old non- pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN), via an unspecified route of administration on left arm on an unknown date in Mar2021 at 12:30 (at the age of 51-years-old), as single dose for COVID-19 immunisation. Medical history included high cholesterol and anxiety started on an unknown date. The patient's known allergy to sulfa meds and hazel nuts. Concomitant medications included Montelukast Sodium (SINGULAIR), Sertraline (ZOLOFT), Levothyroxine (MANUFACTURER UNKNOWN), Lovastatin (MANUFACTURER UNKNOWN); all for unknown indication, from unknown dates and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 17Mar2021 at 10:00, the patient experienced severely swollen lymph nodes with pain radiating to the back. The patient also experienced severe chills and night sweats (probably a fever but didn't take temp). The patient did not receive any treatments for the events. The clinical outcome of the events severely swollen lymph nodes with pain radiating to the back, severe chills, night sweats, probably fever was recovering at the time of reporting. Information about lot number cannot be obtained. No further information is expected.
51 2021-06-21 swelling, lymph node swelling, lymph node pain 1st Shot 04/15/2021, 2nd Shot 05/06/2021. On the weekend of April 24, I found a marble size lump abo... Read more
1st Shot 04/15/2021, 2nd Shot 05/06/2021. On the weekend of April 24, I found a marble size lump above my neck line on the left hand side. It was painful, moved around, and felt swollen. The following Monday April 26, I went into Urgent Care. Dr. stated that I had a small sausage sized, swollen lymph node. I flinched from pain several times. He sent me for bloodwork, chest x-ray, and ultrasound, which I did blood and x-rays on that same day. I had made appointment for ultrasound on May 13. Dr. also called me on that day to say that there were no signs of cancer and to follow up with my dr. I have appointment with her June 29.
51 2021-06-21 swelling Onset w/ myalgias, back pain and severe headache. Next day with swelling and shooting pain in Righ... Read more
Onset w/ myalgias, back pain and severe headache. Next day with swelling and shooting pain in Right arm (Injection was given in Left arm) Shooting pains in bilateral thighs. Migrating polyarthralgia, bilateral hand tingling. Debilitating pain and fatigue that is interfering with activities of daily living including employment
51 2021-06-22 peripheral swelling, lymph node swelling While still in the pharmacy right after the vaccine she started wheezing. Next morning had a low gra... Read more
While still in the pharmacy right after the vaccine she started wheezing. Next morning had a low grade temp, left arm was swollen and lymph nodes in left arm pit was swollen, left breast has a tender lump, terrible headaches and extremely tired. When trying to exercise she is having serve chest pain. Joint pains in shoulder and neck, muscles has pain and is making a popping sound. Right thyroid is swollen and is getting short of breathe.
51 2021-06-22 peripheral swelling SARS-COV-2; drug ineffective; Hurt to pick it up; Redness and heat; Swelling in the arm with a littl... Read more
SARS-COV-2; drug ineffective; Hurt to pick it up; Redness and heat; Swelling in the arm with a little knot; lost appetite; sick; itching off the arm/Itchy and wanted to scratch it/Really Itchy; arm pain/Arm got really sore; arms getting stiff and could barely move it/it got stiff; arm swelled up like a baseball and was really itchy and hot to the touch; arm swelled up like a baseball and was really itchy and hot to the touch; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration, administered in Arm Left on 18May2021 as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included immune system disorder. Patient was a kidney transplant recipient, being an immunocompromised patient would be a contraindication in getting the second dose of the vaccine. There were no concomitant medications. On 28May2021, the patient experienced itching off the arm and wanted to scratch it, arm pain got really sore, arms getting stiff and could barely move, pain, arm swelled up like a baseball and was really itchy and hot to the touch, redness and swelling in the arm with a little knot or mass, sickness and loss of appetite.The patient underwent SARS-COV-2 test which was positive on an unspecified date in the past. As the patient was immunocompromised wanted to know whether she could take the second dose. No follow-up attempts are possible. No further information is expected.
51 2021-06-22 swelling I am having swelling and discomfort on left side of my body since getting the Pfizer vaccine.
51 2021-06-25 lymph node pain racing heartbeat overnight; vertigo; exhaustion; foggy headedness; Headaches; Vision acuity lessened... Read more
racing heartbeat overnight; vertigo; exhaustion; foggy headedness; Headaches; Vision acuity lessened; Sore left underarm; extreme soreness in underarm area (lymph nodes she assumed) Lymph node pain; ad the tightness in chest; Slight trouble breathing; There was tightness in either muscles or lungs in the area, internally, below stern, slightly L&R; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (BNT162B2) at 51-years-old, dose 2 via an unspecified route of administration, administered in Arm Left on 29Apr2021 20:00 (Batch/Lot Number: ER8736) as DOSE, 2 SINGLE for covid-19 immunisation. No pregnant. Medical history included Allergies, obesity, Exercise-induced asthma (diagnosed), Sensitive to Codeine product. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included chlorpheniramine maleate; naproxen sodium (ALEVE). Historical Vaccine included BNT162B2 on 01Apr2021 at 51-years-old for COVID-19 Immunization (Dose Number : 1, Anatomical Location : Arm Left, Batch/lot number : ER8734, Start time: 08:00 PM) experienced Chills in the early evening first, fever overnight, Lethargic for approx a week. The second vaccine hit much, much harder. The patient experienced racing heartbeat overnight, vertigo, exhaustion, foggy headedness/ headaches, vision acuity lessened, extreme soreness in underarm area (lymph nodes she assumed). She still had the tightness in chest and also the sore left underarm, slight vertigo, and mild headaches, exhaustion, slight trouble breathing. The knots and soreness were still in left armpit. Right armpit was fine. There was tightness in either muscles or lungs in the area, internally, below stern, slightly L&R on 13May2021 15:00 with outcome of not recovered. The events were serious due to disability. Trying to get in to see a primary doctor for referral to a cardiologist, which is proving difficult. The patient hoped the symptoms can be lessened. She felt none of this prior to vaccines. The events resulted in Doctor or other healthcare professional office/clinic visit. Not resulted hospitalization prolonged, Treatment received: Unknown. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
51 2021-06-27 peripheral swelling after 2nd covid vaccination (2 weeks after) patients legs swelled up significantly. from her waist d... Read more
after 2nd covid vaccination (2 weeks after) patients legs swelled up significantly. from her waist down is "inflamed" Also states tiredness.
51 2021-06-27 peripheral swelling Bilateral leg swelling - still persists in lower leg, foot and ankle - muscle and joint pain- both s... Read more
Bilateral leg swelling - still persists in lower leg, foot and ankle - muscle and joint pain- both swelling and pain continues until now
51 2021-06-27 swelling Pain in the armpit and it?sswollen
51 2021-06-29 peripheral swelling When I first got the shot my arm was swollen and I had a fever. I also had body aches. When I got th... Read more
When I first got the shot my arm was swollen and I had a fever. I also had body aches. When I got the second shot my arm hurt worse, but it went away. A couple weeks later now, I am not able to remember sentences or word choices. There are certain words that I can't remember to spell and I am a good speller.
51 2021-06-30 oral herpes cold sore on her lip; This is a spontaneous report from a contactable consumer. A 51-years-old fem... Read more
cold sore on her lip; This is a spontaneous report from a contactable consumer. A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 21Jun2021 as dose unknown, single for (at the age of 51-year-old) covid-19 immunisation. The patient's medical history included herpes virus infection. It was reported that, when patient was 10 years old and her brother was 8 years old, they had the oral herpes virus. Patient stated her brother had a small case of it, but she on the other hand had a very bad case of it. Patient stated it went in her mouth, her throat and into her stomach. Patient stated which she thinks now may have been part of hand foot mouth disease. The patient's concomitant medications were not reported. The patient experienced cold sore on her lip on 23Jun2021. Reporter stated that she woke up this morning with it and it's ongoing. Caller states it doesn't disappear unless you have something to make it disappear with. The outcome of the event was not resolved. Information about lot/batch number has been requested.
51 2021-06-30 peripheral swelling Body ache like all over.; Headache; Left arm is swollen.; She got the rash.; Injection site is swoll... Read more
Body ache like all over.; Headache; Left arm is swollen.; She got the rash.; Injection site is swollen.; I started feeling really tired I mean so tired that I couldn't stay awake though I slept for several hours and then I woke up.; My arm was started to getting sore the first day a little bit but the next day which is yesterday was really-really bad.; I couldn't move my arm.; My neck is pretty bad and it's real bad. It's just got pretty much shit.; sick with the flu; sick with the flu; could barely even walk or walk up the stairs; cough; This is a spontaneous report from a Pfizer. A contactable consumer (patient) reported that a 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0185, NDC number, UPC number, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm, upper arm close to my shoulder on 16Jun2021 (at the age of 51 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included bipolar, fibromyalgia and osteoarthritis in hand; all were from an unknown date and unknown if ongoing verbatim. Concomitant medications included alprazolam (XANAX), quetiapine fumarate (SEROQUEL), oxycodone taken for fibromyalgia and tizanidine taken for muscle relaxant therapy, start and stop date were not reported. The patient received first dose of BNT162B2 (Lot no: EW0168) administered in left arm, upper arm close to my shoulder on 26May2021 for covid-19 immunisation. Consumer stated as no prior vaccination (within 4 weeks). The report received as, the patient stated as, I don't think it says on here but my last time the recent one when I got the shot is 2 O' clock that was my appointment time. The first one patient trying to think it could have been the same time as 2 or 3 O' clock. Route of administration was as in a shot. The patient states, she has an autoimmune disorder and several things wrong with her. The patient states, she received two doses of the Pfizer Covid-19 vaccine. She felt fine with the first dose, but with the second dose that the patient received on 16Jun2021, it took patient days to get better, and today is the first day she feels normal again. from 16Jun2021 to today 21Jun2021 she had a headache, body aches, all over like the patient was sick with the flu, could barely even walk or walk up the stairs, had a cough, and her left arm and hand had swollen up along with a little bit of rash where the shot was, and her injection site is swollen as well. The patient stated as, it was the same day it was like I got it up 2 O'clock I stay there for 15-20 minutes went home and then in couple of hours I started feeling really tired I mean so tired that I couldn't stay awake though the patient slept for several hours and then the patient woke up. The patient thinks her arm was started to get sore the first day a little bit but the next day which was yesterday was really- really bad. The patient had headache, body ache like all over, I couldn't move my arm what else. The patient neck was pretty bad and it's really bad. It's just got pretty much shit. The patient stated on treatment as, no medication for the rash, when I got my shot there is slight rash, I am keeping an eye on it to make sure it doesn't grow. Just I am taking Ibuprofen for the extra pain that I got. The patient stated, no, I need to go and to my doctor I am really tasked up for my physical and blood work. No investigation assessment reported. Outcome of the events was unknown. Additional information has been requested.
51 2021-06-30 peripheral swelling stomach cramping; At the site of injection there was bruising and whelps; Bruising on arm; then diar... Read more
stomach cramping; At the site of injection there was bruising and whelps; Bruising on arm; then diarrhea for 6 days and really bad explosive kind; welts and red swollen on arm and then chills and nausea and vomiting and more diarrhea and stomach pain lots.; welts and red swollen on arm and then chills and nausea and vomiting and more diarrhea and stomach pain lots.; welts and red swollen on arm and then chills and nausea and vomiting and more diarrhea and stomach pain lots.; welts and red swollen on arm and then chills and nausea and vomiting and more diarrhea and stomach pain lots.; welts and red swollen on arm and then chills and nausea and vomiting and more diarrhea and stomach pain lots.; welts and red swollen on arm and then chills and nausea and vomiting and more diarrhea and stomach pain lots.; welts and red swollen on arm and then chills and nausea and vomiting and more diarrhea and stomach pain lots.; Tired; I just I feel miserable; it's blowout, it making hard for me to work,; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 01May2021 09:00 (Batch/Lot Number: EW0171) as dose 2, single (at the age of 51-year-old) for covid-19 immunisation. Medical history included anxiety, depression and ocd from an unknown date and unknown if ongoing. The patient previously took codeine for hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA), bupropion hydrochloride (WELLBUTRIN), hydroxyzine hydrochloride (HYDROXIZINE). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number-ER8732) at left arm on 03Apr2021 09:00 as dose 1, single for covid-19 immunisation. On 02May2021, the patient experienced bruising on arm, then diarrhea for 6 days and really bad explosive kind and then welts and red swollen on arm and then chills and nausea and vomiting and more diarrhea and stomach pain lots. Tired. No fun at all and still dealing with this, 6 days out. Have had to be off work as well. Almost went to er last night. The patient stated she was on day 18 now after the second Pfizer shot, she had for covid and she still have stomach issues and diarrhea a lot of it every single day and she had been tested for every single thing as well as for Covid and she does not have any of that. She also stated that it is like every day, it's blowout, it making hard for me to work, there's lot of days she had to take a off so. She further stated she have had test Influenza A and B, two Covid tests and neurovirus toxin, every test available and nothing was coming back positive. So the first shot was on 03Apr2021. Caller stated she was having a really bad reaction to the Pfizer COVID 19 vaccine. She has extreme diarrhea, stomach cramping, and chills off and on. She has been tested by her doctor and everything has come back negative. She was going to the bathroom every 20 min. Now, within 1/2 to 1 hour after eating she has to go to the bathroom. She was not eating much. She started a heavy-duty antibiotic yesterday. She was taking Imodium. At the site of injection there was bruising and whelps I just I feel miserable. They subsided, but then after a bad bought of diarrhea, on about day 12, the red whelps returned. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent 2 covid tests on 06May2021, Nasal swab tests (a rapid one and one with results in 2 to 4 days), result was negative and another Nasal Swab, result pending. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events bruising on arm, then diarrhea for 6 days and really bad explosive kind, welts and red swollen on arm and then chills and nausea and vomiting and more diarrhea and stomach pain lots, tired was not recovered and for rest it was unknown. No Follow-up attempts completed. No further information is expected.
51 2021-07-01 swelling face, swelling Pt began complaining of tingling and swelling of left face, neck and throat about 15 minutes of vacc... Read more
Pt began complaining of tingling and swelling of left face, neck and throat about 15 minutes of vaccine. VS: 156/ 89, HR 84, O2 sats 99% on RA. Paramedics called after IM Benadryl 50 mg given. She was transported by ambulance to the ER. Pt also c/o migraine and of not eating all day.
51 2021-07-05 lymph node pain I am a Medicine Physician. I had many side effects after the Pfizer Vaccines. The first Pfizer Vac... Read more
I am a Medicine Physician. I had many side effects after the Pfizer Vaccines. The first Pfizer Vaccine side effects were worse in terms of the number and the severity of the side effects experienced. The main side effects that I am still having trouble with and going to physicians (ENT, Hematologist, and PCP) about are tinnitus, hearing loss, sinus pain and congestion, and headaches. On 4/24/2021 at about 1:30PM, the initial pain at the injection site upon injection of the first Pfizer vaccine felt like a flu vaccine. About 1 hour after receiving the first Pfizer injection, my entire face and neck became flushed. The flushing was present for 24 hours. Around 10:00PM on 4/24/2021, I developed a headache radiating to the back of my head and down my neck on the left side. I also developed severe sharp stabbing left sided sinus pain (felt like an ice pick jammed up into my nose). This pain had been been under good control with mometasone nasal washes which were started at the end of March 2021. I also developed left arm pain at the injection site that continued to worsen. During the night, I had about 3 episodes of brief 10-second-long chill-like cold tingling wave sensations from the tops of both thighs down to my feet (the soles of both my feet felt tingly) and also waves of multiple chill-like cold tingling sensations from the bottom of my rib cage and radiating up toward both shoulders and down to my elbows. When I awoke at 8:15am on 4/25/2021, my face was still flushed and my entire left arm was so painful that I could not move it. The sensation felt like it was a painful hematoma in my arm; however, fortunately, the arm showed no signs of hematoma—no bruising, no palpable hematoma. Also upon awakening, I continued to have severe sinus pain as well as left sided tooth and left jaw pain. I had left ear pain. The left ear felt like it was shut. I was slightly ataxic and felt foggy. At 9:20AM on 4/25/2021, I developed a low roaring or low-pitched harmonica sound in my ears. I also developed a severe pain in my left eye. My eyes were watering and "glassy" in appearance. Symptoms all seemed to be on the left side rather than the right side. At 10:45AM, I developed severe fatigue and laid down. While laying down, I had one chill-like cold tingling wave sensations from the tops of both thighs down to my feet and two waves of chill-like cold tingling sensations from the bottom of my rib cage and radiating up toward both shoulders and down to my elbows. I fell asleep for 3.5 hours. When I awoke at 2:15PM, it felt like I was getting up after having just been run over by a truck. My temperature was 99.5F. I continued to have a headache, mainly on the left side, throughout the day. I also had general malaise, nausea and decreased appetite the entire day. I was only able to eat 1 ½ bowls of soup, a piece of toast and a cup of hot tea for the entire day. At 3:45PM, I took Pseudoephedrine 60mg for the severe left sided sinus pain over my left eye and my headache and laid down. I had two waves of chill-like cold tingling sensations from the bottom of my rib cage and radiating up toward both shoulders and down to my elbows at 5:50 PM. The persistent left ear and jaw pain were resolved. The left sinus pain was slightly improved. The left arm was sore but slightly improved and I could move it around with less pain. I began to experience a general hot sensation over my entire body. My temperature was 99.6F. At 9:00PM, I took a shower. The shower made my arm feel slightly better. Around 10:00PM, while brushing my teeth, my forehead started to sweat and I again had hot sensations over my body. My left nose and my left arm were both sore. I had a difficult time sleeping, I had two episodes of the chill-like cold tingling sensations described above. I had nausea. I also awoke in the middle of the night to severe pain in my nose and nasal congestion used Afrin nasal spray. When I awoke at 8:30AM on 4/26/2021, I had a headache behind both eyes. My eyes were watering and they were very sensitive to light. I could barely open my eyes when I awoke because of the pain from the light of the day. My left arm pain was much improved and fully moveable. At 10:40AM, I noticed that my inguinal lymph nodes were very painful at the tops of both my thighs and walking was difficult because it made the pain worse. I also had lower back pain. At the start of the day, in terms of pain intensity: my groin lymph nodes and lower back were having the worst pain followed by the headache behind the eyes/ eye pain/ light sensitivity and then the sinus pain. I began to wonder if the vaccine was triggering some past symptoms that were suspicious of an immune/rheumatology problem whose symptoms had not been fully figured out. By 8:10PM, I was feeling that most all the symptoms were slowly improving. I still had slight left arm pain. I had a difficult time sleeping. At 5:00AM on 4/27/2021, I was sweaty, hot and nauseous a couple times. I took 1 Tums and went back to sleep. At 5:45 AM, I developed tingling sensations in the right calf for 45 minutes then chill like sensations down my entire leg twice. I fell back asleep and had bizarre dreams. I woke up startled because of a loud vacuum cleaner sound along with sounds of pots and pans banging in my ear. I had ear pain. I also heard a different mechanical type sound that moved from one side of my head to the other side of my head. I e-mailed to my hematologist at the Center about my side effects. I went to the lab to get my routine labs and INR. At 2:10PM, I developed severe fatigue and slept until 5:30PM. I had little appetite and ate half my supper. When I laid down to go to bed, I had vertigo (room spinning sensation) for about 1 minute. On 4/28/2021, most symptoms were improved or resolved. On 4/29/2021 at 1:00PM, I noted the painful inguinal groin lymph nodes bilaterally that had returned but not as severe as before. This time the lymph nodes hurt worse when sitting than standing. Originally, it hurt worse when standing. Between 4/30/2021 and the date of my second Pfizer vaccine on 5/15/2021, I continued to experience symptoms of tinnitus and occasional bilateral inguinal lymph node pain, pain in the eye/head from light sensitivity and sinus pain/headache. On 5/12/2021, I e-mailed my hematologist office at the center about my side effects.
51 2021-07-05 lymph node pain On 5/15/2021, I received my second Pfizer vaccine at around 1:40PM. Around 10:30PM, I developed hot... Read more
On 5/15/2021, I received my second Pfizer vaccine at around 1:40PM. Around 10:30PM, I developed hot sensation throughout my entire body and my left arm that received the injection as well as my bilateral inguinal lymph nodes became painful. I had restless sleep during the night because of generalized hot sensations and a sore arm. On 5/16/2021 at 11:45AM, I had bilateral groin lymph node pain. I also had tinnitus which was very apparent when there was silence. On 5/17/2021 a 5:40PM, I continued to have tinnitus, a sore left arm and sore bilateral inguinal lymph nodes. On 5/18/2021 at 4:17PM, overall, the number of side effects and their severity were less with Pfizer Vaccine #2 than with Pfizer Vaccine #1. The main side effects for Pfizer Vaccine #2 were fatigue and tiredness, tinnitus, arm pain, bilateral inguinal lymph node pain and nausea. Earlier in the day, I went to the lab to get an INR and wrote an e-mail about my symptoms to my hematologist office. By 5/22/2021, the fatigue/tiredness, arm pain, nausea and bilateral inguinal lymph node pain had subsided. The tinnitus and occasional ear pain on the left side continued but seemed to be improving. Between 5/23/2021 through 6/14/2021, my sinus pain/pressure and congestion on the left side reoccurred and lasted for about 2 days. I also continued to have intermittent sharp pain in my left ear and tinnitus. I also noticed that I was unable to hear birds chirping which I had been able to hear previously. My left ear felt shut and full and seemed to have two different pitches of tinnitus especially noticeable when the environment was quiet. I also had some tinnitus in the right ear which was of a different pitch than the left ear. My hearing did not seem as good. On 6/15/2021, I went to the local ENT to have him examine my nose/sinuses and my ear. I told him that the mometasone nasal sinus washes did appear to help the nasal pain/pressure and congestion but that a day or two after both the first and second Pfizer vaccines, the sinus nasal pain and pressure seemed to come back (despite the mometasone) and lasted for several days. I also told the ENT that after having had the first and second Pfizer vaccines that I had tinnitus; and that the tinnitus was worse in my left ear than my right ear. In addition, my hearing was not as good especially on the left side and that I was having intermittent sharp left ear pains. The ENT performed a rhinoscopy and said I did appear to still have some inflammation and congestion especially in the left side of my nose. He also examined my ears and said I had minimal ear wax and otherwise my ear exam visually looked normal. He told me tinnitus can mean hearing loss. He did a tympanogram which was normal in both ears. He did an audiogram (hearing test) which showed that the right ear had a mild loss at 250Hz then grossly normal hearing with excellent (100%) word understanding at a normal conversational level in a quiet environment. The hearing test showed the left ear had mild to slight Sensorineural Hearing Loss (SNHL) with excellent (96%) word understanding at a louder than normal conversational level, in a quiet environment. The ENT instructed me to continue my mometasone nasal sinus washes. On 6/16/2021, I went to the local PCP and explained to her that after the first Pfizer vaccine and the second Pfizer vaccine that I developed tinnitus primarily in the left ear but also the right ear. I told her I was having hearing loss, intermittent left ear pains and left sided sharp pain/pressure in my sinus and nose. I also told her that I had been having episodes of eye pains and headaches that were made worse with light. I also told her about the very painful bilateral inguinal lymph node pain that I experienced after both vaccines. I expressed concern as to the vaccine causing these symptoms via some autoimmune reaction. She prescribed for me a Medrol Dose Pack: Methylprednisolone 4mg to be taken 6 tabs on day 1 then 5 tabs then 4 tabs then 3 tabs then 2 tabs then 1 tablet.On 6/23/2021, I went to the local hematologist and discussed my sinus symptoms, left sided ear pain, tinnitus and hearing lost that occurred post-Pfizer vaccines. I explained that on 6/22/2021, I had completed the Medrol dosepack that my PCP prescribed and that the severity and number of occurrences of the loud high pitched tinnitus had decreased; but, I still had the low pitched tinnitus and hearing loss. I showed the hematologist the article, "Sudden Sensorineural Hearing Loss: Primary Care Update,". 2016 Jun; 75 (6): 172-4. I pointed out p. 173, Table, 1 which showed that Prednisone is an optimal drug for tinnitus and hearing loss: "Prednisone 60mg daily X 7 days then 40mg daily X 3 days then 20mg daily X 2 days then 10 mg daily X 2 days." The article also states, "Methylprednisolone dose packs are inadequate for therapy because of lower dosing and shorter length of treatment." My hematologist agreed it was reasonable to try a higher dose of Prednisone for a longer period of time. He also referred me a local rheumatologist for further discussion. On 6/24/2021, my local PCP prescribed the 2 week Prednisone taper outlined in the previous paragraph. I had sweating and generalized hot sensations throughout my entire body about 2-3 episodes a day (mostly at night) and lasting about 5-10 minutes while on the Prednisone Taper. My nasal congestion and sinus symptoms improved on the Prednisone taper. My ear pain has improved. I had ear popping sensations on the Prednisone Taper. The loud, harsh high-pitched tinnitus episodes decreased in frequency and intensity. I still have some low pitched tinnitus but it is not as loud. The tinnitus is worse when the surroundings are quiet. I also still have some hearing loss. On 6/29/2021, I obtained an INR which was high at 3.4. I e-mailed my hematolgist office and they felt the high INR was from the high dose Prednisone Taper. My Coumadin dose was adjusted.
51 2021-07-08 lymph node swelling Severe swelling, pain and fever in right armpit. Ice pack and Ibuprofen per doctors office. Still ... Read more
Severe swelling, pain and fever in right armpit. Ice pack and Ibuprofen per doctors office. Still painful and swollen but has gone down some. Temp. check on 07/06/2021 was 99.1 for next 2 days.
51 2021-07-08 lymph node swelling lymph node inflammation of varying intensity causing intermittently sore throat when swallowing, ten... Read more
lymph node inflammation of varying intensity causing intermittently sore throat when swallowing, tenderness to the touch, feeling of enlargement; also general sense or feeling of "being depleted"
51 2021-07-08 lymph node swelling 6/19/21 - 6/27/21: fatigue, muscle and joint aches 6/25/21 - 6/27/21: slight intermittent pain in ... Read more
6/19/21 - 6/27/21: fatigue, muscle and joint aches 6/25/21 - 6/27/21: slight intermittent pain in upper left abdomen. 6/27/21: very short chest pain 6/27/21 - 7/4/21: swollen lymph node in left thigh 7/4/21: sudden pain in center of upper abdomen that radiated to my back along with vomiting. Diagnosed with acute pancreatitis with a blood lipase level greater than 30,000. After testing and assessment, the medical team could not find a cause and advised me to report my case.
51 2021-07-11 lymph node swelling pain from left shoulder to fingers, swollen left lymph node, breast, chest pain left side. Severe ho... Read more
pain from left shoulder to fingers, swollen left lymph node, breast, chest pain left side. Severe hot flashes
51 2021-07-11 swelling face Swelling under left eye Swelling on left eye li Swelling on left side of face
51 2021-07-14 lymph node pain, lymph node swelling Swollen lymph node under that arm and pain up to neck, extreme fatigue for two months after, on and ... Read more
Swollen lymph node under that arm and pain up to neck, extreme fatigue for two months after, on and off fever 1 night. Brain fog- months after...overall unwell feeling.
51 2021-07-15 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: D... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe
51 2021-07-17 axillary mass Large lump under the right arm.; This is a spontaneous report from a contactable consumer, the patie... Read more
Large lump under the right arm.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 20Mar2021 at 12:00 (at the age of 51-years-old) as a single dose, for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on an unspecified date at 11:30, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 16:00, the patient experienced large lump under the right arm. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the event. The clinical outcome of large lump under the right arm was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
51 2021-07-17 swelling face Tinnitus in right ear, which is progressively getting worse. Whooshing sound in head, especially whe... Read more
Tinnitus in right ear, which is progressively getting worse. Whooshing sound in head, especially when laying down. Pressure behind eyes, intermittent swelling on upper cheek and eyelids. Vision problems, especially when changing position from laying down to getting up, sitting to standing, where there is a gray curtain that moves slowly across the field of vision. Head constantly feels pressured and almost as though there is fluid build up.
51 2021-07-18 peripheral swelling Location of site: At my job building. Throbbing pain hasn't stopped. Please help
51 2021-07-19 lymph node swelling, lymph node pain Rash around injection site on left arm.; swollen lymph nodes under left arm; painful lymph nodes un... Read more
Rash around injection site on left arm.; swollen lymph nodes under left arm; painful lymph nodes under left arm; Headache; Inappropriate schedule of vaccine administered.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had allergies to sulfa drugs (unspecified) and codeine (MANUFACTURER UNKNOWN). Concomitant medications included fexofenadine hydrochloride (ALLEGRA), mometasone furoate (NASONEX) and vitamin B complex (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 15Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 31Mar2021 at 18:00, 30 hours after vaccination, the patient experienced rash around injection site on left arm, extremely swollen and painful lymph nodes under left arm and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measure was taken as a result of events. The clinical outcome of the events rash around injection site on left arm, extremely swollen and painful lymph nodes under left arm and headache was not recovered and the outcome of inappropriate schedule of vaccine administration was unknown at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
51 2021-07-19 lymph node swelling Large swollen lymph node in armpit of shot; This is a spontaneous report from a contactable consumer... Read more
Large swollen lymph node in armpit of shot; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 15Jan2021 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, hypothyroidism and depression. The patient had history of allergy to several antibiotics (unspecified). The patient received other prescribed medications (unspecified) within 2 weeks of vaccination for an unknown indication and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Jan2021, the patient experienced large swollen lymph node in armpit of shot. The patient reported that the swollen lymph node went away after 2 weeks. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 05Feb2021 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient reported that 2 months later after the second dose of vaccination, he experienced swollen, red lymph node in the same armpit and reported it to be inflamed one week to date. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported event. The clinical outcome of the event large swollen lymph node in armpit was not resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
51 2021-07-20 lymph node swelling Small rash on injection site; Enlarged lymph sub clavicular lymph node left side; This is a spontane... Read more
Small rash on injection site; Enlarged lymph sub clavicular lymph node left side; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 30Mar2021 at 14:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies. Concomitant medications included probiotics (MANUFACTURER UNKNOWN) and omeprazole (JUICE PLUS OMEGA) for unknown indication from unknown date received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 09Mar2021 at 15:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had known allergies to several medications, food, or other products. On 01Apr2021 at 13:00, the patient experienced small rash on injection site and enlarged lymph sub clavicular lymph node left side. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events vaccination site rash and sub clavicular lymphadenopathy was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
51 2021-07-25 sepsis 7/15/21: Patient arrived to ER due to shortness of breath and dry cough with generalized fatigue. Pa... Read more
7/15/21: Patient arrived to ER due to shortness of breath and dry cough with generalized fatigue. Patient did test positive for COVID-19 on 7/15/21. Diagnosed with viral pneumonia with bilateral infiltrates, severe sepsis, acute hypoxic respiratory failure secondary to COVID-19, acute on chronic CHF. Completed a course of remdesivir, ceftriaxone and azithromycin. 7/25/21: patient discharged from hospital. Note: patient completed 2 COVID-19 vaccines series in May 2021. Patient received first dose of Pfizer COVID vaccine on 4/25/2021, followed by the second dose 21 days later, on 5/16/2021.
51 2021-07-27 peripheral swelling Random headaches on daily basis; my cycle is back in full swing day after my second dose; Bottom num... Read more
Random headaches on daily basis; my cycle is back in full swing day after my second dose; Bottom number of BP rising; Swelling in feet and legs.; Lightheartedness; I really feel that something is just not right; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot umber: EV0164, patient was 51-year-old and not pregnant at the time of vaccination) via an unspecified route of administration, administered in arm left on 23Mar2021 as dose 2, single for COVID-19 immunization. Medical history included ADHD, bipolar, depression, anxiety, colon cancer, migraines, bananas tree nuts, premenopausal. Concomitant medications included amlodipine besilate (5mg); ascorbic acid, ferrous fumarate (VITRON C) both was taken within 2 weeks of vaccination. The patient previously took dilantin [phenytoin] and experienced Allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot umber: EN6208) via an unspecified route of administration, administered in arm left on an unspecified date as dose 1, single for COVID-19 immunization. Patient does not receive other vaccine in four weeks. Reported that never had an issue with bottom number before only top. No COVID prior vaccination. Patient was not tested COVID post vaccination. On 16Apr2021 at 12:00, the patient experienced random headaches on daily basis, my cycle is back in full swing day after my second dose, bottom number of bp rising, swelling in feet and legs, lightheartedness, I really feel that something is just not right. The patient underwent lab tests and procedures which included blood pressure measurement resulted as bp rising on 16Apr2021 as bottom number of BP rising. Patient received treatment for events and increased BP medication. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
51 2021-07-27 swelling face Body was itching; Headache; Body is aching; Body pain; Numbness; Rash is still on my face and my che... Read more
Body was itching; Headache; Body is aching; Body pain; Numbness; Rash is still on my face and my chest; Eyes are red and itchy; Eyes are red and itchy; I have to be shaking shaking my self something; Joints are hurting me; Face is little bit swollen; Throat, I can't even eat anything; Loose appetite; This is a spontaneous report from a contactable consumer (Patient reported for herself). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0187) via an unspecified route of administration, administered in arm left on 08Jul2021 at 12:10 pm (at the age of 51-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had no medical history related to event. The patient had no Family medical history related to event. There were no concomitant medications. No vaccination received 4 weeks prior to COVID 19 Vaccine. On 08Jul2021, at night after the vaccination, the patient experienced body was itching, headache and body was aching, body pain. On an unspecified date in Jul2021, it would be 10 to 12 hours time after the vaccination, the patient experienced, joints hurting, face was little bit swollen, throat she cannot even eat anything, loose appetite, numbness, rash still on her face and her chest, eyes are red and itchy. The clinical course of the events as follows: she stated she took the first dose of Pfizer Vaccine on Thursday on 8thJul. The very day she took it, and she waited there for 15 minutes and then she went to home in the night. She could believe it would be 10 to 12 hours time, I was (incomplete sentence). She felt that her body was itching and the whole night she felt headache and her body started aching. She continued having headache, body ache, and even her joints were hurting, it came to a point, her thigh, the leg to the bottom of her buttock was trying to be numb and she had to be shaking herself something. She stated that she put alcohol to stop the itching and then she takes Tylenol for headache almost every 4 hours, she said that she put alcohol on her face, the part which was itching the most and because of that alcohol she put it, her skin turned black. Her face was little bit swollen and her throat, she cannot even eat anything and she loose appetite. She stated the numbness would not stay for long but the itchy and rash was still on her face and her chest. She stated that she does not know if she is supposed to go to the ER. She stated that her second dose is supposed to be on 29thJul. She reported basically, it stays the same as the first time she experienced the rashes, it was the same and not going away and it was not getting worst either. No Investigation Assessment was provided. The outcome of the events body was itching, and rash was still on her face and chest was not resolved and the outcome of the other events was unknown at the time of this report.
51 2021-07-28 lymph node pain Right arm pain in lymph nodes in underarm; Pain radiating from shoulder to fingers; Fingers numb; Fi... Read more
Right arm pain in lymph nodes in underarm; Pain radiating from shoulder to fingers; Fingers numb; Fingers numb and tingling; Pain on right side of body below shoulder; Right arm pain increases as the day goes on and with use.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 20Mar2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer in 2012, lymphoedema in left arm and mastectomy bilateral in 2012. The patient had no known allergies to medications, food, or other products. Concomitant medications included tapentadol hydrochloride (NUCYNTA) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN602) via an unspecified route of administration in the right arm on 27Feb2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 14:00, the patient experienced right arm pain in lymph nodes in underarm, pain radiating from shoulder to fingers, fingers numb and tingling, pain on right side of body below shoulder and right arm pain that increased as the day went on and with use. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with prednisone, advil 800 mg, every 4 hours and tylenol 1000mg in between. The clinical outcome of the events right arm pain in lymph nodes in underarm, pain radiating from shoulder to fingers, fingers numb and tingling, pain on right side of body below shoulder and right arm pain was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
51 2021-07-28 lymph node swelling Swollen lymph nodes in right breast; Feeling breast pain; Tenderness down part of arm, on the side; ... Read more
Swollen lymph nodes in right breast; Feeling breast pain; Tenderness down part of arm, on the side; Tenderness in under arm/armpit; This is a spontaneous report from a contactable pharmacist, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Mar2021 at 13:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included mild asthma and Monosodium Glutamate (MSG) intolerance. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received type 1 antihistamines and experienced slight allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 17:30, 5 days after the vaccination, the patient experienced swollen lymph nodes in the right breast, axils and underarm and felt breast pain, tenderness under arm, down part of arm, on the side and in armpit. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events swollen lymph nodes in right breast, axils and underarm and felt breast pain, tenderness under arm, down part of arm, on the side and in armpit was resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
51 2021-07-28 neck mass, lymph node swelling a lot of pain; a lot of little balls around her neck; her lymph nodes to be swollen.; This is sponta... Read more
a lot of pain; a lot of little balls around her neck; her lymph nodes to be swollen.; This is spontaneous report from contactable consumer (Patient herself). A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 09Mar2021 (at the age of 51-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had her first dose of the PFIZER-BIONTECH COVID-19 VACCINE on 09March2021. A week later after her first dose, on 16March2021, she reported that she woke up with a lot of pain and a lot of little balls around her neck. Her doctor ordered for her ultrasound and assessed her lymph nodes to be swollen. Further evaluation was conducted, and her oncologist assessed that she looks okay and should get the second dose. Her main question was that, given that it has been 77 days or 11 weeks past her 1st dose. Does she still need to get a second dose, or does she need to start over again with her vaccination. Spoke mainly on the Second Dose Later than 3 Weeks as advised by Agency. Advised of Pfizer-BioNTech COVID-19 Vaccine vaccination series to be given 2 doses given 3 weeks apart.1. The patient underwent lab tests and procedures which included ultrasound on unspecified date in Mar2021. Outcome of the events was unknown. Information on the Lot/Batch number has been requested. Follow up #1 (26Jul2021): Follow-up activities closed: Batch/lot number not available.
51 2021-07-29 lymph node swelling Fever; Headache; Tiredness; Swollen lymph nodes under left arm, left side of neck and base of head o... Read more
Fever; Headache; Tiredness; Swollen lymph nodes under left arm, left side of neck and base of head on left side; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 10:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia syndrome. The patient did not receive any concomitant medications. The patient was allergic to nonsteroidal anti-inflammatory drugs (NSAIDs). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 22:00, the patient experienced fever, headache, tiredness swollen lymph nodes under left arm, left side of neck and base of head on left side for extended time (7 days). The clinical outcome of fever, headache, tiredness, swollen lymph nodes was unknown at the time of this report. No follow up attempts are needed; Information about lot/batch number cannot be obtained.
52 2021-01-02 swelling Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for a few seconds it - did not go past 15 minute observation. Felt nauseated for a brief time - did not go past the 15 minutes. About 25 minutes after the tip of my tongue, section of my bottom lip and sides of my tongue were tingly. The tip of my tongue continues to be like that day #2 after and there is a small blood blister underneath the tip of my tongue. Parts of my body feel a little itchy an hour after vaccine and continues very infrequently at this time and it disappears in seconds.
52 2021-01-03 peripheral swelling Arm soreness Arm swelling Headache Right side neck pain Bumps on both cheeks (face)
52 2021-01-03 swelling face Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to b... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to benzonatate. Patient answered "no" to questionnaire about allergic reactions prior to vaccination. 11 minutes after vaccination, patient reported tingling of lips and swelling of face. Developed hoarseness. SWAT was called and patient given benadryl and taken to ED (1055). Patient received steroids and H1/H2 blockers in addition to epinephrine. Patient brought to ICU for monitoring. Patient continued on therapy and was discharged 1/2 at 1113. Patient returned to ED on 1/3 at 1558 with macular papular rash on leg, chest and back with itching on eyelids and face. No respiratory involvement. Patient given benadryl and predinisone and discharged from ED at 2016.
52 2021-01-04 peripheral swelling Nausea, lightheadedness, headache, fatigue, sore/swollen arm
52 2021-01-05 swelling face Fever, pain below the injection site, fatigue/weakness, facial swelling; her PCP sent her to the ER ... Read more
Fever, pain below the injection site, fatigue/weakness, facial swelling; her PCP sent her to the ER for IV fluids and oral Tylenol.
52 2021-01-07 lymph node pain, lymph node swelling Fever, chills, nausea, lymph node enlargement with pain
52 2021-01-07 swelling Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Ski... Read more
Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Skin is sore from the fever. Headache, temp 100.3. Weak and loopy, slept all day. Hurts under the arm. SOB.
52 2021-01-08 lymph node swelling Myalgia Left cervical lymphadenopathy, muscles feel weak. Narrative:
52 2021-01-10 swelling face 52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccin... Read more
52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccine received on 1.6. Patient has not worked since 1/6. Her symptoms started 1/7. She showed the provider a photo from her phone from 1/9 where her face was diffusely swollen and erythematous. She has not had dyspnea. She reports low grade fever off and on since vaccination. No n/v. She had stomach cramps for a whole, but those have fully resolved. At the visit on 1.11, her main symptoms are puffy eyes, and somewhat swollen and flushed face. Patient also reports dizziness, and still feels unsteady. Patient received a dexamethasone and depo-medrol injection in clinic on 1.11. Patient given return instructions. Provider will follow up in a few days to check on the patient.
52 2021-01-11 lymph node swelling swelling and tenderness with palpable lump and lymph nodes at rt clavicular region and right axilla,... Read more
swelling and tenderness with palpable lump and lymph nodes at rt clavicular region and right axilla, starting approximately starting 45 hours post injection and continuing at time of this report
52 2021-01-12 swelling face left side of face got swollen, 5 lb weight gain on 1/8/21, resolved on 1/12/21
52 2021-01-13 anaphylactic reaction Systemic: Anaphylaxis-Severe, Systemic: Nausea-Medium, Systemic: Fainting-Medium
52 2021-01-13 lymph node swelling apple size lymph node arm pit of immunized arm after 2nd dose
52 2021-01-13 swelling face I received the Pfizer #EL3246 Vaccine, exp 4/30/2021 on Jan 12, 2021 through the Health Department a... Read more
I received the Pfizer #EL3246 Vaccine, exp 4/30/2021 on Jan 12, 2021 through the Health Department and developed severe facial swelling, primarily around the right eye. The left eye has slight swelling. Please note: I had a previous reaction to Tetanus many years ago that included swelling. In addition, I have had headaches and gastrointestinal symptoms.
52 2021-01-13 swelling face PFIZER-BIONTECH COVID 19 VACCINE EVA Soreness in arm, up neck and into face/temple/cheek and jaw on ... Read more
PFIZER-BIONTECH COVID 19 VACCINE EVA Soreness in arm, up neck and into face/temple/cheek and jaw on injection side. Face /cheek feels sore, swollen and numb- coming from neck, into face, up to temple/forehand, into cheek and jawline. Is this possible Bells Palsy ?
52 2021-01-14 lymph node pain Woke up with moderate fatigue, nausea, more severe arm pain than day before; Woke up with moderate f... Read more
Woke up with moderate fatigue, nausea, more severe arm pain than day before; Woke up with moderate fatigue, nausea, more severe arm pain than day before; Felt sweaty/chills, neck lymph glands tender; Felt sweaty/chills, neck lymph glands tender; neck lymph glands tender; Moderate arm pain that night; This is a spontaneous report from a contactable Nurse (patient). A 52-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL1284), intramuscularly on 04Jan2021 16:30 at single dose for COVID-19 immunization. Anatomical Located at Arm Right. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication which the patient received within 2 weeks of vaccination included colecalciferol (VITAMIN D), tocopherol (VITAMIN E), magnesium, ibuprofen, paracetamol (TYLENOL). The patient previously took amoxicillin and experienced allergy. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient experienced Moderate arm pain that night on 04Jan2021 19:00 and woke up with moderate fatigue, nausea, more severe arm pain than day before on 05Jan2021. At 23 hours post injection on 05Jan2021, the patient also felt sweaty/chills, neck lymph glands tender. All symptoms gone at 48 hrs post injection. The patient did not receive any treatment for the reported events. The outcome of the events was recovered in Jan2021. This case reported as non-serious.
52 2021-01-14 lymph node inflammation I got my 2nd dose on Wednesday and felt fine all night. On Thursday, I started to have a low grade ... Read more
I got my 2nd dose on Wednesday and felt fine all night. On Thursday, I started to have a low grade fever with body aches and tiredness. On Thursday night about 6pm, I developed severe swelling under my left arm and down the left side of my ribs.
52 2021-01-14 white blood cell count increased I had no side effects after my vaccine on 12/24/20 until 1/8/21. On Friday, 1/8/21 at 830pm I began ... Read more
I had no side effects after my vaccine on 12/24/20 until 1/8/21. On Friday, 1/8/21 at 830pm I began with severe abdominal pain, low grade fever, nausea and loss of appetite. My abdominal pain persisted and worsened over the next 24-36hours. I presented to the ER on Sunday, January 10, 2021 at 8am with severe right lower quadrant pain, pelvic pain, nausea and low grade fever. I was promptly diagnosed with appendicitis and taken to the OR at approximately 2pm on the same day. In the OR my appendix was gangrenous, there was pus in the pelvic area nd fluid in my peritoneum. My appendix was not ruptured. My appendix was removed as well as part of the omentum. I remained in the hospital on IV Metronidazole and Ciprofloxacin for 2 days and was discharged on 1/13/21 at 9pm. I am continuing to recvoer at home on the same 2 antibiotics in oral form. I have a JP drain that is still in place. Of note I had two negative COVID 19 tests on 1/9/21 and 1/10/21. Both were PCR tests.
52 2021-01-16 lymph node swelling headache, muscle ache, fever, chills, fever, lymphadenopathy, injection site pain, tiredness
52 2021-01-16 swelling face I waited 15 per protocol walked back to my unit and noticed my face was puffy and lips felt numb. Th... Read more
I waited 15 per protocol walked back to my unit and noticed my face was puffy and lips felt numb. The Np on my unit looked in my throat and noticed my throat was red and swollen. No difficulty with breathing. Oxygen 100 on RA. Benadryl and additional Pepcid taken. Swelling in throat decreased, facial swelling dissipated as well. Lips were tingling for hours and dissipated after additional Benadryl taken.
52 2021-01-17 axillary mass Painful hard lump in left airpit
52 2021-01-17 peripheral swelling Received vaccine at 11:30 on 1/15, at 5:30pm developed itchiness from head to toe, took 25mg of Ben... Read more
Received vaccine at 11:30 on 1/15, at 5:30pm developed itchiness from head to toe, took 25mg of Benadryl 1/15 at 9:30pm developed hives on back, stomach, hips and upper thighs,, hands were swollen took 25mg of Benadryl 1/16 at 3am took another 25mg Benadryl hives and itching. 1/16 630am took 25mg Benadryl and Claritin hives and itching improving. 1/16 at 9am all but 2 hives resolved to oatmeal bath and applied hydrocortisone. 1/16 at 630pm felt throat was swelling, voice change, tingling lips and thick tongue took 50 mg of Benadryl went to ER around 730pm. Was given Pepcid and 50mg prednisone in the Emergency Room. 1/16 11pm.Discharged home with prescriptions for prednisone, Benadryl and epi-pen and Pepcid. Continues now with lingering sore throat
52 2021-01-18 lymph node swelling Headache, fatigue, swollen left axillary lymph node
52 2021-01-19 peripheral swelling RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FE... Read more
RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FEVER
52 2021-01-19 swelling face Approximately 15 minutes after receiving second vaccine dose, patient reported feeling light-headed ... Read more
Approximately 15 minutes after receiving second vaccine dose, patient reported feeling light-headed and a subjective swelling of her left cheek. Patient was tachycardic and hypertensive; taken to ER for observation. Received a dose of oral diphenhydramine 50 mg. Was ultimately discharged home in stable condition.
52 2021-01-20 swelling Severe swelling of left upper arm, left anterior chest wall; Severe swelling of left upper arm, left... Read more
Severe swelling of left upper arm, left anterior chest wall; Severe swelling of left upper arm, left anterior chest wall; Underarm and neck with pain; Underarm and neck with pain; Heat; Redness; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686; Expiration date was not reported) on 08Jan2021 (15:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 10Jan2021 (15:00), the patient had severe swelling on the left upper arm and left anterior chest wall; underarm and neck were with pain; was in heat; and had redness. The adverse events resulted in the patient having a visit on the doctor or other healthcare professional office/clinic. The patient had received treatment for the reported adverse events. The outcome of the events, 'severe swelling on the left upper arm and left anterior chest wall', 'underarm and neck were with pain', 'heat' and 'redness', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.
52 2021-01-21 swollen extremities GENERALIZED RASH WITH PRURITUS. SHORTNESS OF BREATH. EDEMA IN EXTREMITIES, FACE, NECK . FEVER. PATI... Read more
GENERALIZED RASH WITH PRURITUS. SHORTNESS OF BREATH. EDEMA IN EXTREMITIES, FACE, NECK . FEVER. PATIENT TOOK BENADRYL. SYMPTOMS RESOLVED NEXT MORNING
52 2021-01-22 lymph node swelling Dizziness, enlarged lymph nodes from axilla to mandible on same side as shot. Body aches, chills, h... Read more
Dizziness, enlarged lymph nodes from axilla to mandible on same side as shot. Body aches, chills, headache.
52 2021-01-24 lymph node swelling Neck pain b/l sides radiating upwards to the jaw, swollen PAINFUL cervical lymph nodes, Fatigue,
52 2021-01-24 lymph node swelling Fever of 99-99.5 body aches. Nausea. Lack of appetite. Next day swollen lymph nodes only left side.
52 2021-01-24 neck mass Lump on the left side of neck, pain on the underarm
52 2021-01-24 peripheral swelling Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and ... Read more
Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and shoulder became swollen; she also has something else going on in her shoulder; achy all over in her neck, arm, and shoulder; achy all over in her neck, arm, and shoulder; Felt sick to her stomach; her arm was sore that evening; This is a spontaneous report from a Pfizer Sponsored Program made from a contactable consumer (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EK5730) at single dose on left arm on 23-Dec-2020 for COVID-19 immunization. Medical history included sleep apnea; high blood pressure; COPD (chronic obstructive pulmonary disease). Concomitant Medication was nothing new, her normal medication, she took vitamins, and high blood pressure medication. She had had no positive test for Covid prior to the vaccine, she had had no antibody test, she had had no issues with vaccine in the past. The patient experienced left arm swelling in Jan2021 and pneumonia on 08Jan2021. The patient worked in a hospital and received her first dose on 23Dec2020 and she was supposed to get the second dose today but she was not at work today. She was wanting to know if she should go ahead and take the second dose because her arm was still swollen. The product was the Covid vaccine. She stated that her arm was still swollen, when she got shot she was fine, her arm was sore that evening (Dec2020) and then nothing, then a weekend after new years her arm and shoulder became swollen (Jan2021) and she had been to the ER and the doctor thought the swelling was because of the shot, but she also had something else going on in her shoulder (Jan2021). So in the meantime she went to the ER and they took X rays, and they told her that she was starting to develop pneumonia. She was going back to work tomorrow, being that she was on the antibiotics now, still had swelling in the arm, and had pneumonia, should she still get the 2nd shot. She noticed the swelling Saturday after New Years. She was also achy all over in her neck, arm, and shoulder (Jan2021). She felt sick to her stomach, this was all the first Week of Jan2021. She went to the ER, she was not admitted and came home the same day. She went to the ER on 08Jan2021. 08Jan2021 was also when the pneumonia was diagnosed. The name of antibiotic she was prescribed was doxycycline. She started it on Saturday 09Jan2021, she was prescribed 100 mg 2 pills a day for 10 days. When they did the X ray, they said that the pneumonia had showed up, or she was just starting to get pneumonia. Patient stated that she didn't believe because they made a comment about the way she was laying however she had been taking the medication and feeling better. She was schedule for the second dose today. She did reschedule for Friday, and wanted to know if she should still get it. In the ER, they said it could have been a blood clot and so they did a scan to find blood clots but it was negative. The outcome of event pneumonia was resolving; events left arm swelling and shoulder became swollen was not resolved. The outcome of rest evens was unknown..
52 2021-01-24 swelling face My face felt hot; face and lip were slightly swollen; face and lip were slightly swollen; This is a ... Read more
My face felt hot; face and lip were slightly swollen; face and lip were slightly swollen; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek4176) via an unspecified route of administration at left arm on 12Jan2021 17:00 at single dose for COVID-19 immunization. Medical history included COVID prior vaccination. Concomitant medication included unspecified medications. The patient previously took hydrocodone bitartrate paracetamol (VICODIN) and experienced known allergies. After approximately 45 minutes after vaccination, her face felt hot and her face and lip were slightly swollen from 12Jan2021 18:00. No treatment received. No other vaccine in four weeks. No COVID tested done post vaccination. The outcome of the events was recovering.
52 2021-01-25 lymph node swelling On same day of injection, recipient developed a headache, swollen lymph nodes under arm, red and war... Read more
On same day of injection, recipient developed a headache, swollen lymph nodes under arm, red and warm swollen injection site area
52 2021-01-25 lymph node swelling Extreme fatigue followed by swelling of lymph nodes, swelling of tongue, difficulty swallowing. Pati... Read more
Extreme fatigue followed by swelling of lymph nodes, swelling of tongue, difficulty swallowing. Patient took Benadryl 50mg and drank lots of water. Patient states she was severely dehydrated. Patient stated that she "should have probably gone" to the hospital but she did not. She did have an Epipen on her person if needed at the time but decided not to use it.
52 2021-01-26 peripheral swelling Swollen arm, redness, hot Headache Chills Body aches Runny nose Sneezing
52 2021-01-26 swelling face Face swelling and numbness, lightheaded, hot flashes with cold clammy skin
52 2021-01-27 lymph node swelling Injection site tenderness; fatigue; headache; fever; chills; muscle pain; axillary swollen lymph nod... Read more
Injection site tenderness; fatigue; headache; fever; chills; muscle pain; axillary swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular at left arm on 13Jan2021 at 16:00 at single dose for COVID-19 immunization. The patient medical history included hypertension and penicillin allergy, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took BIAXIN and experienced allergy on an unspecified date, the patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at left arm on 23Dec2020 at 15:45 at single dose for COVID-19 immunization. On 14Jan2021 at 03:00, the patient experienced injection site tenderness, fatigue, headache, fever, chills, muscle pain, axillary swollen lymph nodes. The patient outcome of the events was recovered.
52 2021-01-27 lymph node swelling slightly light headed; rt hand got red & hot; rt hand got red & hot; numb, heat in rt arm/right sid... Read more
slightly light headed; rt hand got red & hot; rt hand got red & hot; numb, heat in rt arm/right side of jaw felt numb; Blood pressure went up to something over 90; fatigued; it hurt to open my mouth (gland by rt ear felt swollen); got a line of inflammation in my rt inside cheek; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= EL0140), intramuscular at right arm on 23Dec2020 16:45 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication in two weeks included Multi vitamin, tocopherol (VITAMIN E), vitamin d3, bioidenticle estrogen/progesterone. The patient previously took Iodine, metronidazole (FLAGYL), Doxycycline, clarithromycin (KETEK); and known allergies to them. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient felt slightly light headed. Within 5 minutes right hand got red & hot, numb, heat in right arm & right side of jaw felt numb as if blew up balloons. Blood pressure went up to something over 90. The patient took a benadryl. Next few days v fatigued & on p.m. of 24th it hurt to open her mouth (gland by right ear felt swollen). The patient got a line of inflammation in her right inside cheek & a tissue mound that had not gone away. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
52 2021-01-27 lymph node swelling Lymphadenopathy; mild fatigue; Myalgia; This is a spontaneous report from a contactable physician (p... Read more
Lymphadenopathy; mild fatigue; Myalgia; This is a spontaneous report from a contactable physician (patient). A 52-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), intramuscular in the left arm on 12Jan2021 at 16:30 as a single dose to prevent COVID. The patient's concomitant medications were not reported and it was reported that she had no relevant medical history. The patient previously received the first dose of BNT162B2 on 22Dec2020 at 14:00. The patient did not receive any other vaccine/s on the same date as BNT162B2, did not have prior vaccination within four weeks of receiving BNT162B2, and did not experience any adverse event following prior vaccinations. The patient experienced mild fatigue and myalgia on 13Jan2021, and lymphadenopathy on 14Jan2021. Seriousness for the events was reported as serious (medically significant). The patient received her second dose of the Pfizer Covid Vaccine on 12Jan2021 at 16:30. She experienced mild fatigue and myalgia after 24 hours which has improved. She clarified that the mild fatigue and myalgia resolved by this morning. She felt lymphadenopathy in her lower neck and supraclavicular area. Stated it was almost fullness she can feel, there was no redness and it was not tender. She was hoping this was related to the vaccine that she got in her left upper arm. She went to the CDC and Pfizer website and saw that lymphadenopathy was mentioned but it was a small percentage. The patient declined any treatment. The events did not require a visit to the Emergency Room of Physician's office. Outcome of the events fatigue and myalgia was recovered on 15Jan2021, while for the event lymphadenopathy was not recovered. The reporter's causality assessment between the events and BNT162B2 for the events fatigue and myalgia was related, while for the event lymphadenopathy was unknown. Information about the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events fatigue, myalgia and lymphadenopathy are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-01-27 lymphatic obstruction Myalgia right lymphedema, fatigue, chills/sweats Narrative:
52 2021-01-27 swelling I just noticed my right neck is a little swelled. My neck looks thicker than usual.
52 2021-01-28 lymphatic obstruction Right arm lymphedema; This is a spontaneous report from a contactable nurse (patient). A 52-year-old... Read more
Right arm lymphedema; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date: unknown), intramuscular in the right arm, on 11Jan2021 13:00 at a single dose for covid-19 immunization. Medical history included migraines and penicillin allergy. Concomitant medication included rizatriptan. The patient took first dose of bnt162b2 (lot number: EL0140) on 23Dec2020 via intramuscular in the left arm for covid-19 immunization. The patient is not pregnant. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 12Jan2021, the patient experienced right arm lymphedema. Event was not treated. Outcome of the event was not recovered.
52 2021-01-28 swelling face Mild Soreness and fatigue first day; chills and light headache the next 2 days. Symptoms resolved on... Read more
Mild Soreness and fatigue first day; chills and light headache the next 2 days. Symptoms resolved on January 21. Generalized body itching started on January 26 and then woke up on January 27 with facial swelling. Instructed to follow-up with PCP or urgent care.
52 2021-01-28 swelling face Started to feel an irritation behand my right ear, then along my jaw line. Thought it was irritatio... Read more
Started to feel an irritation behand my right ear, then along my jaw line. Thought it was irritation from mask wearing. Then I had a burning sensation in my hair. Similar to a sunburn then getting chills. Wednesday night I noticed three pimple like bumps in my hair--right posteriorly. A bit itchy at times. Thursday right under my jaw line seems to have swelling. This morning it feels the same. Burning like irritation in my hair.
52 2021-01-31 anaphylactic reaction Anaphylaxis, tongue swelling, difficulty breathing, & hives, Ambulance transported pt to the nearest... Read more
Anaphylaxis, tongue swelling, difficulty breathing, & hives, Ambulance transported pt to the nearest ER, required Epinephrine injections 1mg IM X3, IV Methylprednisolone 50mg and IV Benadryl 50mg, pt had to be transferred to higher level of care due to ongoing symptoms and was kept until 1/24/21. Pt said staff at the ER told her they knew they should report the reaction to someone but didn't know how to report it.
52 2021-01-31 lymph node swelling Pt states first s/s at 1500 she started to feel body aches, HA, dizzy, nausea, loss of appetite chil... Read more
Pt states first s/s at 1500 she started to feel body aches, HA, dizzy, nausea, loss of appetite chills and fever of 100.7 with episodes of sweating profusely. 1/19/21 Pt states fever continues, body aches, (L) axillary lymph node swelling, HA, Nausea and a episode of Tachycardia that she recorded temp. ranged 101-102.2. 1/21/20 Pt stated to have cont. fever 102.2, HA, BA, sweating and lymph nodes swelling from (L) axillary to back painful. Pt States on 1/21/21 cont. sweating loss of appetite, nausea, weakness, fatigue injection site pain, no redness, warm, and palpable lump. Pt stated 1/23/21 body aches and fever. Pt resting drinking fluids as tolerated and taking advil 400 mg PRN 4mg Zofran
52 2021-02-01 lymphatic obstruction, swelling Chills, Fever, Myalgia, Rash, Hives, Lymphedema, and Swelling
52 2021-02-03 anaphylactic reaction Day 6 I felt extremely lethargic, fatigued and with extreme joint pain upon waking. I took lunch at ... Read more
Day 6 I felt extremely lethargic, fatigued and with extreme joint pain upon waking. I took lunch at 3:30 pm consisting of almonds, cranberries and cheese bites and 2 mandarin oranges. Approx 10 minutes after eating I began to cough uncontrollably and had difficulty clearing my throat. Drank water thinking orange juice had gone down wrong. 10 more minutes my bottom lip began tingling, tongue felt thick, chest tightness, light headed. I called clinic who suggested I call for medical emergency because of my previous anaphylaxis. Taken to ED, given epi pen, prednisone, pepcid, monitored and discharged after 2 hours
52 2021-02-03 swelling face, swelling, lymph node swelling Within 10 mins I had swelling, tingling and some numbness in my face and neck. I was checked by EMS ... Read more
Within 10 mins I had swelling, tingling and some numbness in my face and neck. I was checked by EMS at the site. Waited another 20 mins and the symptoms did not get worse or rapidly improve. I had a prescheduled doctor appointment and went directly to the doctor's office after the vaccine. Dr. confirmed that I had swelling and redness in my face and prescribed Methylpredsisolone 4mg 21 pack of steriods to take. That medication removed the symptoms. On 02/01/21, 24 hrs after the last dose of the pack, the face swelling and tingling returned. As recommended I took Benedryl 2 tablets / 3 doses. I returned to Doctor's office on Tues 02/02 where she prescribed Presnisone 20mg for 5 days after seeing the swelling in my face and she said my lymph nodes were swollen as well.
52 2021-02-03 swelling 2pm felt mild tired, muscle soreness. 8:30pm developed severe fatigue, chills. 10pm developed swolle... Read more
2pm felt mild tired, muscle soreness. 8:30pm developed severe fatigue, chills. 10pm developed swollen golf ball size knot. Tired but couldn't sleep. For 2 days severe hip bone pain, couldn't walk. day 2 H/A. Had constant severe urination. SOB, Low back pain. Entire skeletal system felt like she was in a car accident. Took 800mg ibuprofen. Had no energy 48 hours. 3rd day started to recover. Could not eat meals for 2 days.
52 2021-02-06 swelling face My eyes and face swelled up and my left eye has been red, itchy, and sore since then.
52 2021-02-07 axillary mass Thrombosis in right axilla at superficial tributary. No Pulmonary embolism. Axilla pain developed wi... Read more
Thrombosis in right axilla at superficial tributary. No Pulmonary embolism. Axilla pain developed within 48 hours of vaccine. 1 week later she noted a lump at axilla. Presented to clinic for evaluation on 2/8/21
52 2021-02-07 peripheral swelling lump on injection site, hot, redness size of hand, fever 100.0 for 2 days on and off, swelling of ar... Read more
lump on injection site, hot, redness size of hand, fever 100.0 for 2 days on and off, swelling of arm, fatigue, hangover feeling
52 2021-02-09 neck mass Lump on the left side of neck, pain on the underarm; Lump on the left side of neck, pain on the unde... Read more
Lump on the left side of neck, pain on the underarm; Lump on the left side of neck, pain on the underarm; This is a spontaneous report from contactable pharmacist. A 52-year-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246) via intramuscular in the left arm, on 12Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Patient is not pregnant. It was unknown if patient had COVID prior vaccination. It was unknown if patient received other vaccine in four weeks. Patient previously received first dose of BNT162B2 (Lot number: EL0140) via intramuscular in the left arm on 23Dec2020 at the age of 52 years for COVID-19 immunisation. Patient experienced lump on the left side of neck, pain on the underarm on 12Jan2021. It was unknown if patient received treatment for events. It was unknown if patient tested COVID post vaccination. Outcome of the events was recovering.
52 2021-02-10 lymph node swelling Swollen lymph nodes; This is a spontaneous report from a contactable other healthcare professional (... Read more
Swollen lymph nodes; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3246, expiration date was unknown), via an unspecified route of administration on the left arm on 13Jan2021 at 10:30 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Jan2021 at 10:00, the patient experienced swollen lymph nodes, which was considered non-serious. The adverse event did result in a doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse event. The patient was not recovered from the event.
52 2021-02-14 peripheral swelling starting around 8 pm 2/12, patient experienced sharp pain around the liver and gallbladder. by the t... Read more
starting around 8 pm 2/12, patient experienced sharp pain around the liver and gallbladder. by the time she went to bed, she was experiencing extreme bloating and gas, and developed diarrhea soon after. on saturday 2/13, the patient's arm began to swell and a rash developed on several parts of the body (trunk, arms, legs). swelling and hives went away after patient took benadryl, diarhhea and bloating have lessened, by are still present as of monday 2/15
52 2021-02-16 lymph node pain, lymph node swelling Tired Vaccine site tender Lymph node in arm pit slightly swollen and tender
52 2021-02-17 lymph node pain, lymph node swelling chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and i... Read more
chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and in front of my ear; swollen, sore glands to the left side of my jaw, underneath and in front of my ear/gland pain; nasal drainage to my left sinus/nostril; inside of her left cheek felt like there were lesions breaking out but there were none; her cheek and teeth were sore, as if she had a sinus infection; her cheek and teeth were sore, as if she had a sinus infection; sinus drainage became blood tinged. It is pale pink in in color, not constant/bloody drainage; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 18Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension from an unspecified date and appendectomy in 1991. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE). The patient previously took atropine sulfate (SULFAS ATROPINE, reported as Sulfa), quinolones and doxycycline and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (lot number: EL0142, expiry date not reported) in the left arm on 30Dec2020 at 5:30PM at single dose for COVID-19 immunisation. On 19Jan2021 02:00, she started with chills and by 24 hours, her temp got to 103.5 (fever). The patient took Tylenol. The temp stayed in the 100-101 range for the next 24 hours. Then, she started to have swollen, sore glands to the left side of her jaw, underneath and in front of her ear. The inside of her left cheek felt like there were lesions breaking out but there were none. She then had copious amounts of thin nasal drainage to her left sinus/nostril. Over the next few days, the gland pain subsided but she still had drainage and her cheek and teeth were sore, as if she had a sinus infection. She would occasionally take Tylenol and on occasion, took cold and flu medicine. Then, her sinus drainage became blood tinged. It was pale pink in in color, not constant, but when the drainage started, it was sudden and just drained with no warning. She smelled old blood. She turned in bed and the drainage occurred suddenly and she can taste old blood. Almost two weeks later, and she still had bloody drainage. Clinical outcome of the events was not recovered.
52 2021-02-17 lymph node swelling Enlargened lymph node in mouth; headache in temples; This is a spontaneous report from a contactable... Read more
Enlargened lymph node in mouth; headache in temples; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: E13302) solution for injection, via an unspecified route of administration in left arm on 11Jan2021 13:00 at a single dose for Covid-19 immunization. Medical history included lower back pain. Concomitant medications: patient received medications two weeks prior to vaccination. The patient had the first dose of the vaccine on 22Dec2020 at 1pm (lot/batch number: El0140) in left arm. Patient reported that after 2 days (13Jan2021), at around 3pm she got a headache in her temples that would not go away. She went to the urgent care Covid test done which was negative. Had ER visit for headache then with continued headache, then 2 weeks later another ER visit. She also had enlarged lymph node in mouth that was found 2 days ago (03Feb2021). Patient visited ER for the events. As treatment, patient was given Rocephin IV, migraine cocktail, morphine and Dilad. The patient underwent lab tests which included Nasal swab: negative on 16Jan2021 (Rapid test). Prior to vaccination, patient was not diagnosed with Covid-19. Outcome of the events was not recovered. No follow-up activities are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
52 2021-02-19 lymph node swelling Left Supraclavicular Lymphadenitis the day after receiving the vaccine in Left Deltoid
52 2021-02-20 swelling Mod to severe local reaction and redness, swelling. Fevers 101.4, nausea, HA, chills, body aches, fa... Read more
Mod to severe local reaction and redness, swelling. Fevers 101.4, nausea, HA, chills, body aches, fatigue lasting 24 hours.
52 2021-02-21 lymph node swelling Itching, swelling at injection site, pain, heart palpitations, lymph node swelling
52 2021-02-21 swelling face States 30-40 minutes post injection face and lips began to swell. Took Benadryl x3 and symptoms reso... Read more
States 30-40 minutes post injection face and lips began to swell. Took Benadryl x3 and symptoms resolved by next morning
52 2021-02-21 swelling ed in ER: given predisone and breathing treatment and was was released at 1:36 pm. Was given an Rx t... Read more
ed in ER: given predisone and breathing treatment and was was released at 1:36 pm. Was given an Rx to take 50 MG of Prevacid to take 1x a day for 5 days. Saturday: 2/20/2021 -- Took 50 mg of prevacid at 9 am and 10 mg of pepcid 4:50 pm. Eyes swelled, lump in throat Went to ER Was admitted for observation at hospital. Received predisone and benedryl through IV 1:30 bottom lip started to swell was given 25 mg of benadryl by mouth Around 7:30 am scalp started to itch - Was given 20 mg of predisone orally Around 9 am rash on face was given 50 mg of benadryl Around 2:30 pm Doctor came into room because my throat felt tight. She looked at it and said "its not too bad." She had the nurse give me benadryl via interveniously Was discharged around 3:30 pm on Sunday, February 21, 2021 Monday: 2/22/2021 Around 1:15 pm felt lump in throat, felt like my neck was swollen, took 25 mg of benadryl. Called Doctor. Took another 25 mg of Benadryl. Still didn't feel right. Went over to Dr office, my asthma and allergy doctor. At Dr office, I was given two injections of medication. (He told me what it was, but I cant recall the names.) He sent me home with the following instructions: zyretc 10 mg am and pm bendryl 25 mg every 4 hours as needed pepcid 20 mg am and pm predisone 20 mg 3x1 day tomorrow take 20 mg of predisone I am to call his office after 1 pm tomorrow 2/23/2021 to give status report on how I am doing
52 2021-02-22 axillary mass exhaustion, fever of 102, bone pain, chills, muscle/joint aches, headache, sweating, lump (size of s... Read more
exhaustion, fever of 102, bone pain, chills, muscle/joint aches, headache, sweating, lump (size of small apple) in my left armpit. All symptoms subsided by Wednesday except exhaustion and lump.
52 2021-02-22 lymph node pain, lymph node swelling I had light headedness,breaking out severe sweats, nausea and vomited (1). I was transported to ER w... Read more
I had light headedness,breaking out severe sweats, nausea and vomited (1). I was transported to ER with a 103.5 fever lasted for 10 days, Covid test, Epipen,swollen lymph nodes(right arm) painful,increased fatigue.During the 10 day period I had went to the ER again 5th day got tested for Covid and rechecked symptoms.
52 2021-02-23 lymph node swelling Strong, prolonged and persistent headache. Pain and upset stomach, inappetence. Generalized pain in ... Read more
Strong, prolonged and persistent headache. Pain and upset stomach, inappetence. Generalized pain in bones and joints. Fever. Pain and swelling in the armpit of the arm where I was vaccinated.
52 2021-02-23 lymph node swelling Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swal... Read more
Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 26Jan2021 (09:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included anemia and allergies. Concomitant medications included an unspecified allergy shot. The patient was not pregnant at the time of vaccination. On 26Jan2021 (12:15), the patient had felt pains; lymph nodes had swelled; had pain on tongue; extreme dehydration; fatigue; and difficulty swallowing. The patient had received diphenhydramine (BENADRYL) as treatment for the events, and drank lots of water. The outcome of the events, 'felt pains', 'lymph nodes swelled', 'pain on tongue', 'extreme dehydration', 'fatigue' and 'difficulty swallowing', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.
52 2021-02-24 lymph node swelling I have a 3 inch in diameter mass of swollen lymph nodes under my left arm (had both shots in left ar... Read more
I have a 3 inch in diameter mass of swollen lymph nodes under my left arm (had both shots in left arm). I read online that this is a sign of my body fighting the vaccine and it is a good sign. I went to my doctor just to have it checked out and because both of my eyes look like I have pink eye. My doctor isn't sure if my eyes have anything to do with the vaccine but said probably not. She said that I needed to report my mass as it is not one of the most common side effects. I also went to the health department, where I had both shots, and had them look at the mass. They said the same thing about my body fighting the vaccine. My doctor and the health department said that while they have seen the swollen lymph nodes from the shot, they haven't seen such a large mass like mine. Both of them said I needed to report this.
52 2021-02-25 swelling face Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild
52 2021-02-25 swelling, peripheral swelling Swelling. Obvious in hands, rings tight, could not remove. +3 pound weight increase overnight decrea... Read more
Swelling. Obvious in hands, rings tight, could not remove. +3 pound weight increase overnight decreased in 48 hours, persists in shot arm, axillary and arm
52 2021-02-28 anaphylactic reaction Anaphylaxis developed over the hours, preceded by confusion, rapid heart rate, tingling of face/arm... Read more
Anaphylaxis developed over the hours, preceded by confusion, rapid heart rate, tingling of face/arms/chest, and feeling like moving through water.
52 2021-02-28 peripheral swelling Pain and swelling in left armpit. I've been applying warm compresses to area off and on for a couple... Read more
Pain and swelling in left armpit. I've been applying warm compresses to area off and on for a couple of hours per day at home.
52 2021-02-28 swelling face Swelling in the face; This is a spontaneous report from a non-contactable other health professional.... Read more
Swelling in the face; This is a spontaneous report from a non-contactable other health professional. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration on 27Jan2021 (at the age of 52years) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling in the face on 28Jan2021. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was recovering. This case is non-serious. No follow-up attempts are possible. No further information is expected.
52 2021-03-03 swelling Pt after discussion with treating allergist elected to complete dose 1 of Pfizer COVID-19 vaccinatio... Read more
Pt after discussion with treating allergist elected to complete dose 1 of Pfizer COVID-19 vaccination. Per pt report she had premedicated with Benadryl 100mg po prior to immunization and brought along her prescribed epi-pen. After reciept of vaccination, she proceed to recovery area where she was dictated to 30 minutes of observation, approximately 7 minutes after inoculation began having symptoms consistent with upper airway swelling and self-administered epi-pen and called for medical assistance. EMS was then called and upon arrival found her in stable condition and transported the patient to emergency room at Hospital.
52 2021-03-07 lymph node swelling, lymph node pain Lymph node in right armpit was swollen and very tender for 4 days. Swelling subsided by 4th day. T... Read more
Lymph node in right armpit was swollen and very tender for 4 days. Swelling subsided by 4th day. Tenderness subsided by third day. 1st and 2nd day large and very painful.
52 2021-03-07 lymph node swelling 1/2 hour after receiving the vaccine she felt like her she felt like her throat was swelling and scr... Read more
1/2 hour after receiving the vaccine she felt like her she felt like her throat was swelling and scratchy. She said it scared her , and she ended up stopping at a store and took Benadryl and then she was ok. She?s doing better today but her Lymph nodes are swollen under her arm.
52 2021-03-07 peripheral swelling Side effects are rash on legs and Arms & itching on back On the 3rd day swelling a little bit on foo... Read more
Side effects are rash on legs and Arms & itching on back On the 3rd day swelling a little bit on foot
52 2021-03-09 lymph node swelling, lymph node pain glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side... Read more
glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side; vaccines were given in the left arm because she was left-handed; Back pain; spasms; fever; she felt like the inside of her eyes were on fire; She had a moist cough; spine pain; nausea; vomiting; She had numbness and tingling around the outside of mouth; She had numbness and tingling around the outside of mouth; She had pain in the arm at the injection site; knees would buckle; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302) at single dose on 27Jan2021 via an unknown route in left arm for Covid-19 immunization. She was diagnosed diabetes six years ago (as of 23Feb2021), and her last A1C was 6.1 in Dec2020, had chronic edema since her last child was born 26 years ago. Concomitant drugs included furosemide (LASIX) 400 mg twice daily, potassium 10 meg three times daily, omeprazole (PRILOSEC) 40 mg once daily, and metformin hydrochloride (METFORMIN ER) 1000 mg twice daily, all ongoing. She did not feel like the medication she takes are relevant because she had been taking them for a very long time. Historical Vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140) intramuscular injection in left arm on 04Jan2021 for Covid-19 immunization and experienced back pain, diagnosed with COVID in between the first and second vaccine, headache, arm pain at the injection area, severe back spasms in the thoracic and lumbar (AER 2021200627). Patient experienced back pain 2-3 days after the first dose, headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given Voltaren and Flexeril. She was taking 1 gram of Tylenol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. The reporter assessed headache, arm pain at the injection area, back pain, severe back spasms in the thoracic and lumbar were related to suspect vaccine. After the 2nd dose of the vaccine, patient experienced back pain in Jan2021, sharp, stabbing, crushing pain and spasms in Jan2021, fever for a couple of days in Jan2021, knees would buckle in Jan2021, glands were swollen and when swallows, sharp pain on one side on 09Feb2021, felt like the inside of her eyes were on fire in Jan2021, moist cough in Jan2021, spine pain in Jan2021, nausea and vomiting in Jan2021, numbness and tingling around the outside of mouth in Jan2021, pain in the arm at the injection site in Jan2021, injection site was about a silver dollar size and was red and warm to touch in Jan2021. The event clinical course was as follows: The second dose was given on 27Jan2021. She was getting over COVID and had to wait until the 27Jan2021 to get second dose. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021 with results of her PCR test on 13Jan2021. She was diagnosed with COVID in between the first and second vaccine due to an exposure not the vaccine. At hour 25 after receiving the second dose symptoms started. Severe back pain in the entire spine. It was sharp, stabbing, crushing pain and spasms. When the back would spasm her knees would buckle. She had a fever for a couple of days. 102 fever and she felt like the inside of her eyes were on fire. She has never had that before. She had a moist cough and still has a moist cough. The spine pain was better, but it is not gone away yet. Normally she does not have back pain. At first the pain was an 8 out 10 now (as of 23Feb2021) it was 5 out of 10. Also had nausea and vomiting. She had numbness and tingling around the outside of mouth. That lasted for two days. She had pain in the arm at the injection site. The injection site was about a silver dollar size and was red and warm to touch. She had pain at the injection site and pain in the arm. Both vaccines were given in the left arm because she was left-handed. She thought she would be using that arm more. She did go to Urgent Care after the second dose as well. They gave her a shot of Toradol and another prescription for Voltaren twice a day and Flexeril at bedtime because she can't stay awake when she takes it. She has missed work because of this. The back pain and cough was almost a month now (as of 23Feb2021). She reported no matter what she did she did not get it to go away. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of Tylenol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She has been taking 1000mg Tylenol three times a day and now she was taking it two times a day. She used Tylenol and generic, SunMark Acetaminophen (Lot number: OLE2349B, expiry: Sep2022). Regarding seriousness of headache, made a different in the vision. It was throbbing. for back pain: it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor. for arm pain at the injection area: gripping was not easy and moving her arm was painful. She is left handed. Heat worked better than ice. Ice made things worse. for cough: it had not been disabling. it was irritating because it had been almost 30 days. She knows it was different than the COVID cough because it was moist and when she had COVID it was a dry cough. Regarding seriousness of nausea and vomiting: it was debilitating and she couldn't go anywhere because she was throwing up with every move she made. The pain made it worse. The reporter assessed moist cough, nausea and vomiting, arm pain at the injection area were related to suspect vaccine. No investigation assessment performed. Outcome of fever, inside of her eyes were on fire, pain in the arm at the injection site was resolved. Outcome of back pain, moist cough was not resolved. Outcome of spine pain was resolving. Outcome of the other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the back pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including spine CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-03-09 lymph node swelling Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain, swelling and redness x 3 days Tiredness x ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain, swelling and redness x 3 days Tiredness x 2 days Headache x 2 days Muscle pain x 2 days Chills x 2 days Joint Pain x 2 days Fever up to 104.0 degrees x 2 days Nausea x 2 days Feeling Unwell x 2 days Swollen Lymph node left collarbone x 4 days
52 2021-03-09 swelling R hand pain, redness, swelling, weakness, tingling
52 2021-03-10 lymph node swelling Swollen left axilla noticed 2 days after 2nd covid vaccine2/4/21. (same side as the vaccine was giv... Read more
Swollen left axilla noticed 2 days after 2nd covid vaccine2/4/21. (same side as the vaccine was given) I had a mammogram done 2/16/21 and was told I had abnormal results in my left lymph nodes in axilla. I had a left axilla ultrasound done 3/9/21 and the lymph nodes are still abnormal. I have been asked to come back in 8 weeks for another ultrasound.
52 2021-03-11 lymph node swelling, swelling pt states that she started itching between the left shoulder and left breast. As she scratched her ... Read more
pt states that she started itching between the left shoulder and left breast. As she scratched her breast she felt a small bump and noticed a brown spot. She contacted her OB/GYN via portal to let her know that about these symptoms. The Doctor advised her to see a Dermatologist. She contacted her once again since she felt like something was wrong and was told again to see a Dermatologist. Pt saw Dermatologist on 3/4/2021 and was told it did not look skin cancer and ordered some cream. Pt let Dr. know that she had taken the vax recently and that she also has breast implants. The Doctor did a small exam but did not feel a lump, but this doctor is not an OB/GYN. Pt went to an already scheduled mammogram on 3/11/2021 but they would not complete the annual exam since she was having pain issues so she was rescheduled for a diagnostic exam on 3/17/2021. Pt believes she has felt swollen lymph nodes under her left arm and has had intermittent pain for about 3 weeks now. The pain seems to move around from breast to her back.
52 2021-03-11 swelling face Patient experienced rash and facial/mouth swelling approximately 5 minutes after receiving vaccine. ... Read more
Patient experienced rash and facial/mouth swelling approximately 5 minutes after receiving vaccine. Patient received Epinephrine 0.3 ml of 1 mg/ml solution IM, plus benadryl 50 mg p.o. Patient was transported to ED.
52 2021-03-12 peripheral swelling 15 min. after shot, my neck became warm and flushed, slightly red. By 30-40 minutes after shot, my f... Read more
15 min. after shot, my neck became warm and flushed, slightly red. By 30-40 minutes after shot, my face was also flushed and the inside of my mouth (mostly roof of my mouth) and lips were itchy/tingly. Then, I took 2 Zyrtec 10 mg. as instructed by my allergist if I had a reaction. Within an hour, the flushing and itchiness were gone. 2 days later - had strange pain, swelling, and warmth in upper left shin below knee. Worried about possible blood clot, I took 2 baby aspirin. Pain and swelling went away. Not sure if related to vaccine but unaware of anything else that could have been different.
52 2021-03-13 lymph node swelling Started experiencing nausea and swollen lymph nodes on Saturday, March 13.
52 2021-03-13 peripheral swelling Very bad pain in left arm, swelling from shoulder to elbow, swelling in left leg from just below kne... Read more
Very bad pain in left arm, swelling from shoulder to elbow, swelling in left leg from just below knee to toes feels like my skin is going to split. Right side is fine.
52 2021-03-13 swelling face Patient reports long history of taking ibuprofen/NSAIDS. After 2nd dose of vaccine 2/2/21 she took ... Read more
Patient reports long history of taking ibuprofen/NSAIDS. After 2nd dose of vaccine 2/2/21 she took took ibuprofen about 27-28 hours later on 2/3/21 due to aches/headache. She developed face/lip swelling and tingling. She was seen by provider via video visit and told she needed to be seen in person. She went to urgent care and was prescribed EpiPen PRN. On 2/22/2021 she was having some back-pain and took ibuprofen. About 1 hour later she developed same response with face swelling/tingling. She does feel her reaction is caused by the ibuprofen but she reports this being a new reaction since the vaccine since she routinely took ibuprofen prior to the vaccine.
52 2021-03-15 lymph node swelling Body aches, fatigue, lymphadenopathy left neck/axilla.
52 2021-03-15 peripheral swelling Unable to lift arm within 10 hours. In 18hrs was shaking and extremely cold. Had temp of 100.9. That... Read more
Unable to lift arm within 10 hours. In 18hrs was shaking and extremely cold. Had temp of 100.9. That lasted for 6 hours and transitioned to burning up. During this time I had severe pain in all joints from my neck to my hips. My fingers swelled as well. My legs felt fine and no headache. Tylenol and ibuprofen helped my fever but did not alleviate my pain symptoms. My shot was Friday evening. By sunday afternoon my fever was gone as well as the pain in all but my arm. But is was down to manageable.
52 2021-03-18 lymph node swelling Chills and Body Aches began the following morning after the injection and by 2:00 pm in the afternoo... Read more
Chills and Body Aches began the following morning after the injection and by 2:00 pm in the afternoon a large (ping pong ball sized) lump developed in the left axillary area that is very painful. The pain is constant when area is touched or with any arm movement. It feels like a knife is stuck inside my left axilla. I am guessing it may be a lymph node that swelled, but have not had it checked by a doctor. My last mammogram on November 16th, 2020 was clear and no indication of any lumps or swollen lymph nodes. This new lump appeared the following day after my Covid 19 vaccine.
52 2021-03-18 lymph node swelling Feel an armpit swollen lymph lump; Body warmer than usual; Injection site pain; This is a spontaneou... Read more
Feel an armpit swollen lymph lump; Body warmer than usual; Injection site pain; This is a spontaneous report from a non-contactable consumer reporting for herself. This is the second of two reports. A 52-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot En6201, via an unspecified route of administration in left arm on 23Feb2021 13:40 (at the age of 52 years) at single dose for covid-19 immunisation. The patient previously received the first dose of bnt162b2, Lot En9264, via an unspecified route of administration in left arm on 02Feb2021 13:30 (at the age of 52 years) at single dose for covid-19 immunisation and experienced injection site pain for 1 day. Medical history included high blood pressure. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Allergies to medications, food, or other products were none. Concomitant medication included losartan, vitamin d3, ubidecarenone (Q10). The patient experienced injection site pain on 23Feb2021, body warmer than usual on 24Feb2021, feel an armpit swollen lymph lump on 25Feb2021. Laboratory data included body temperature 37.3C on 24Feb2021, and normal on 25Feb2021. No treatment was received for the events. The events were non serious with outcome unknown. No follow-up attempts are possible. No further information is expected.
52 2021-03-18 lymph node swelling Fever; Muscle ache; Fatigue; Lymph node in left armpit swollen to the size of a small; laryngitus; l... Read more
Fever; Muscle ache; Fatigue; Lymph node in left armpit swollen to the size of a small; laryngitus; lips are also now swollen; earache; lingering cold symptoms/feels like a head cold; sore throat; slight cough; tongue significantly swollen; Less than 19 days between dose 1 and dose 2; Less than 19 days between dose 1 and dose 2; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself. A 52-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation . Medical history included psoriasis , blood cholesterol increased . Concomitant medication(s) included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced hypersensitivity and swollen tongue. The patient received the first dose of bnt162b2 vaccine on 04Feb2021. The patient experienced tongue significantly swollen on 23Feb2021 07:00 with outcome of recovering , fever on 23Feb2021 07:00 with outcome of recovering , muscle ache on 23Feb2021 07:00 with outcome of recovering , fatigue on 23Feb2021 07:00 with outcome of recovering , lymph node in left armpit swollen to the size of a small grapefruit on 23Feb2021 07:00 with outcome of recovering , laryngitus on 23Feb2021 07:00 with outcome of recovering , lips are also now swollen on 23Feb2021 07:00 with outcome of recovering , feels like a head cold on 23Feb2021 07:00 with outcome of recovering , earache on 23Feb2021 07:00 with outcome of recovering , lingering cold symptoms on 23Feb2021 07:00 with outcome of recovering , sore throat on 23Feb2021 07:00 with outcome of recovering , slight cough on 23Feb2021 07:00 with outcome of recovering. Swollen tongue was considered an Important Medical Event. The patient received the second dose 18 days after the first dose and this is considered an off label use. Follow up information has been requested.
52 2021-03-18 swelling face Fever of 102, Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue... Read more
Fever of 102, Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue, increased heart rate, wheezing, joint pain, severe nausea, diaherra, possible seizure, confusion.
52 2021-03-20 lymph node swelling Swollen lymph node under left armpit (not in the arm pit) kind of near side of breast. About 3 inch... Read more
Swollen lymph node under left armpit (not in the arm pit) kind of near side of breast. About 3 inches around. It showed up yesterday around 3 or 4 pm -and I have taken naproxen. Too soon for outcome.
52 2021-03-21 axillary mass Grapefruit sized lump in left axilla
52 2021-03-21 oral herpes I have broken out with fever blisters on my lips.
52 2021-03-21 peripheral swelling warm and itchy toes, look like chillblains, swollen, tender, red, and looking like burst blood vesse... Read more
warm and itchy toes, look like chillblains, swollen, tender, red, and looking like burst blood vessels on 2 toes on one foot, and one toe on the other foot, started on 16 or 17th, March, still visible on March 22 - used some home made remedies and some triamcinolone, acetonide cream 0.1 % for the inflammation
52 2021-03-22 peripheral swelling, lymph node swelling Pain in under arm and what appears to be a knot. Assuming it is a swollen lymph gland.
52 2021-03-22 peripheral swelling Patient states she had a rash on chest, palms on hands and stomach. She had swelling in the hands. S... Read more
Patient states she had a rash on chest, palms on hands and stomach. She had swelling in the hands. She said it started the day after receiving the vaccine.
52 2021-03-23 swelling Patient developed urticaria days 5-7 post vaccination. Day 7-10 developed angioedema tongue- not in... Read more
Patient developed urticaria days 5-7 post vaccination. Day 7-10 developed angioedema tongue- not involving lips.
52 2021-03-23 lymph node swelling, lymph node pain Eight days after the initial vaccine injection, a painful nodule appeared. I consumed a large amoun... Read more
Eight days after the initial vaccine injection, a painful nodule appeared. I consumed a large amount of (simple and complex sugar) calories (around 4,000) the night before 3/13/21. On the day of 3/13/21 I woke up with swelling and noticed a painful lump, the size of a small grape above the left medial clavicle, within the supraclavicular cervical triangle. Saw my doctor on 3/18/21 and she mentioned that the inflamed lymph node is probably due to the vaccine. The lump is still with me, the size is the same, however the area in and around the lump is not as tender and painful today 3/24/21. This coming Friday 3/26/21 is my appointment for the second dose of the Pfizer BioNTECH vaccine shot.
52 2021-03-23 lymph node swelling, lymph node pain Light headedness; Swollen/ painful lymph nodes in armpit.; painful lymph nodes in armpit.; This is a... Read more
Light headedness; Swollen/ painful lymph nodes in armpit.; painful lymph nodes in armpit.; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 52-year-old, reported as currently 51-years-old, female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6200) via an unspecified route of administration in the left arm on 19Feb2021 at 16:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing, and penicillin allergy from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID. Concomitant medications include paracetamol (TYLENOL) and synthetic elderberry [Sambucus nigra] syrup, both from unknown dates for unknown indications. The patient had not received any other vaccines in four weeks. The patient previously received the first dose of BNT162B2 (lot number EL9261) in the left arm on 29Jan2021 at 16:15 (at the age of 52-years-old) for COVID-19 immunisation. On 21Feb2021 at 08:30 the patient experienced swollen/painful lymph nodes in armpit and light headedness on the second day after the second dose. No treatment was provided for the events. The clinical outcomes of light headedness and swollen/painful lymph nodes in armpit were unknown. It was also reported that the patient had not been tested for COVID since vaccination.
52 2021-03-23 lymph node swelling, lymph node pain Arm at injection site and lymph node swelled to approximately 2 inches round the following morning w... Read more
Arm at injection site and lymph node swelled to approximately 2 inches round the following morning when I woke up. The arm is hot to the touch. Both places were extremely painful (especially the lymph node). The lymph node finally went down after 3 days. However, the lump at injection site is still large and now it's hard and it has the area has expanded to a "Covid Arm" rash, which covers my the majority of my upper arm. I was symptomatic with chills, aches for the first two days and the lump/lymph node issue is still happening and it's been 5 days.
52 2021-03-23 lymph node swelling Had vaccination shot #2 in right deltoid. Went to the observation area for the 15 minute period. Aft... Read more
Had vaccination shot #2 in right deltoid. Went to the observation area for the 15 minute period. After approximately 7 minutes, I felt my throat "swelling." I got up and went to the RN who administered shot. They called the RN over. Vital signs were stable, airway intact, able to speak full sentences. No shortness of breath. It took more effort to swallow. Right arm sore. They monitored me for another 15 minutes. No worsening symptoms. Swelling not improving. Recommended going to the ER (I'm an RN and this was administered at my hospital). Was escorted to ER. Hooked up to monitor. Slight redness noticed on both arms. No hives. IV started. Given IV Benadryl, famotidine, solu-medrol. No improvement. Hooked up to a monitor and given epi sub-Q. Monitored for approximately 60 minutes with improvement of throat swelling. Discharged to home with prescription for prednisone, famotidine and Benadryl x 5 days. At home, approximately 8 hours after shot, work up feeling itchy, took Benadryl PO with relief of symptoms approximately 45 minutes later. Followed up with MD on 1/21. No change in medications. Asymptomatic during the course of medications. Finished course of medications on the morning of 1/23. Later that evening started feeling tired, had chills, swollen glands. Went to bed early. On 1/24 symptoms continued including lack of appetite, increased fatigue, brain fog. Symptoms continued until 1/25 and gradually improved over the week.
52 2021-03-23 peripheral swelling her arm was swollen/ hand was also swollen; the joint in her shoulder felt like it was going to spli... Read more
her arm was swollen/ hand was also swollen; the joint in her shoulder felt like it was going to split off. It was extremely painful; her arm was swollen/ It was extremely painful; had been awake two nights unable to sleep due to pain; The pain was also creeping up her neck; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient (pregnant: no) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En7200), via an unspecified route of administration in left arm on 16Feb2021 at 14:00 at single dose for covid-19 immunisation. The relevant medical history included latex allergy and bee allergy, all from an unspecified date. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), modafinil and unspecified thyroid medication. The patient stated that her arm was swollen and the joint in her shoulder felt like it was going to split off. It was extremely painful. Her hand was also swollen and she had to remove her rings. She had been awake two nights unable to sleep due to pain. The pain was also creeping up her neck. The events started on 18Feb2021 at 22:00. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment included steroids and pain killers sling for arm. No covid prior vaccination and no covid tested post vaccination. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.
52 2021-03-24 anaphylactic reaction itchy-redness on arms, throat clear, allergic to ASA only= anaphylaxis history, positive NSAIDs, neg... Read more
itchy-redness on arms, throat clear, allergic to ASA only= anaphylaxis history, positive NSAIDs, negative dysphagia, negative airway or oropharynx component, admin 50 mg benadryl PO 12:45, admin famotidine 20 mg PO 1300, BP 130/80; HR 98; O2 sat 98% R.A., pharmacist monitored over time, pharmacist gave PO meds for home zyrtec and famotidine
52 2021-03-24 oral herpes Fatigue, chills, and high fever in excess of 103 degrees.
52 2021-03-24 swelling, swelling face I felt my throat closing up, making it more and more difficult to swallow or breathe; my throat felt... Read more
I felt my throat closing up, making it more and more difficult to swallow or breathe; my throat felt like a mild cold; more difficult to swallow; difficult to swallow or breathe; hives on my neck; swollen face and neck; swollen face and neck; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 12:00 (Batch/Lot Number: EN 620H) as single dose for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient previously took polio vaccine for immunization and experienced allergy, nickel and experienced allergy, chloroxylenol and experienced allergy, cetirizine hydrochloride (ZYRTEC) and experienced allergy, clarithromycin (CLARITIN) and experienced swelling face. The patient stated that, "After the vaccine was administered (18Mar2021 12:00) my throat felt like a mild cold making it a little more difficult to swallow. As I was sent to the high risk area I was monitored by a nurse. Upon leaving I got into my car that was warm inside. As I was driving I felt my throat closing up, making it more and more difficult to swallow or breathe. I went to a (store) and spoke to the pharmacist there. She advised me to take Benadryl immediately. She noticed hives on my neck and a swollen face and neck. As Benadryl took effect the hives receaded and the swelling of my face and neck went down. I went back to the vaccination site and seemed medical attention from the (Department name) Department team. They checked my vital signs and released me after a waiting period without any further medication being administered. I was given an appointment for 08Apr2021. I am concerned about an adverse reaction at the second appointment. Is it better to wait a little longer for the second dose to be given?" Patient is not pregnant. Therapeutic measures were taken as a result of the events included Benadryl. Outcome of the events was resolving.
52 2021-03-24 swelling Patient is experiencing redness, swelling and severe itching. The itching started 3/24/21 and was m... Read more
Patient is experiencing redness, swelling and severe itching. The itching started 3/24/21 and was mild, but patient stated it has progressively gotten worse.
52 2021-03-25 anaphylactic reaction Raised red rash on chest and anaphylactic symptoms
52 2021-03-25 lymph node swelling Flash of light and heat from head to toe 10 minutes after 1st dose. Numbness and tingling on face l... Read more
Flash of light and heat from head to toe 10 minutes after 1st dose. Numbness and tingling on face lips and tongue 60 minutes after 1st dose. Premedicated with Pepcid 20 mg and Benadryl 50mg 1 hour prior to 2nd vaccination with no adverse reactions occurring. Presented with popping, in ears, eye blurriness, numbness on face and head, swollen glands on bilateral neck, burning in chest happening in waves 2 -3weeks after 2 nd dose. Normal CPK, CBC and CMP results. 2/4/2021 episodes of heat throughout body, questionable palpitations, headaches, blurry vision, numbness on head and face, feeling faint and unbalanced during episodes. - comes in waves. Electric shocked under skin all over body and once in Bihar eyes. Normal brain MRI and follow up bloodwork. Visits to neurologist, GYN and ophthalmologist.
52 2021-03-25 peripheral swelling Day of injection started having pain in right armpit like a bruise. It has spread and very sore. It... Read more
Day of injection started having pain in right armpit like a bruise. It has spread and very sore. It is swollen also
52 2021-03-26 anaphylactic reaction Shortness of breath, swelling of throat, atypical anaphylactic
52 2021-03-27 lymph node swelling Pain and discomfort in right arm pit with a noticeable large swollen lymph nodes. Currently still s... Read more
Pain and discomfort in right arm pit with a noticeable large swollen lymph nodes. Currently still slightly swollen but not painful as of today 03/28/21. Second dose is scheduled for 04/10/21.
52 2021-03-27 peripheral swelling Approximately 10 minutes following vaccine, experienced L shoulder swelling (surrounding vaccine si... Read more
Approximately 10 minutes following vaccine, experienced L shoulder swelling (surrounding vaccine site) and swelling and pustular rash and swelling with redness of L hand
52 2021-03-28 peripheral swelling medium size red circle on arm-- with lump. Lump grape size/circle bigger than a plum. Tender to to... Read more
medium size red circle on arm-- with lump. Lump grape size/circle bigger than a plum. Tender to touch. No itchiness
52 2021-03-30 lymph node swelling Severe fatigue, headache, fever. When those symptoms started going away, my left underarm lymph node... Read more
Severe fatigue, headache, fever. When those symptoms started going away, my left underarm lymph node swelled and became extremely painful. As of the time reporting this my underarm still hurts.
52 2021-03-30 swelling After 1hour / 1 1/2hour from injection start tingling left side of tongue, lip, swelling the throat ... Read more
After 1hour / 1 1/2hour from injection start tingling left side of tongue, lip, swelling the throat After 2hours find a red burning rash under breast/torax.Called health clinic, the Triage nurse directed me to hospital.Went to the Emergency room. Main Hospital Team Dr. Diagnose:allergic reatcion+Yeast infection. 7:28PM gave 3 pills prednisone. Pescription for Prednisone 20mg 3for4days, nyastatin podwder for rush, epinephrine injection in case of anaphylaxis, benadryl as needed.While I was at ER, the tingling/swelling expand my entire body left side. This night I had to remove wedding ring, today the face still swelling/warming+almost same/little bit worsening simptoms
52 2021-03-31 lymph node swelling About 2 weeks after the first dose, my lymph nodes on the left side of my neck and behind my earlobe... Read more
About 2 weeks after the first dose, my lymph nodes on the left side of my neck and behind my earlobe were very swollen and it was hard to turn my head. Also had a terrible headache. The swelling lasted 5 days and has gone down now. The headache lasted 2 days. I had a slight fever and body aches and tiredness for about 5 days after the vaccine.
52 2021-03-31 lymph node swelling swollen lymph node under left armpit the day after receiving the 2nd Phizer shot. It was a large si... Read more
swollen lymph node under left armpit the day after receiving the 2nd Phizer shot. It was a large size, about the size of a golf ball
52 2021-03-31 peripheral swelling, lymph node pain Swelling of most of L arm, hot to touch,red,painful,armpit lymph node pain, Headache Tired Light hea... Read more
Swelling of most of L arm, hot to touch,red,painful,armpit lymph node pain, Headache Tired Light headed Joint pain Temperature Red cheeks, hot to touch Stiff neck Congestion Coughing
52 2021-03-31 swelling Mar 29-6pm Left arm injection site began to hurt and painful to touch Neck muscles on right side of ... Read more
Mar 29-6pm Left arm injection site began to hurt and painful to touch Neck muscles on right side of neck and tongue began to swell Extreme fatigue took over body Mar 29-8pm Rash and itching in following regions: Around collar area/bra line/buttocks/back of thighs/lower back/behind knees/in elbow crease/back of arms Injection site swollen and painful Mar 30-2am Painful abdominal bloating and gas nausea frequent urination chills/arms and feet would not warm up muscle pain joint pain Mar 30 2:30-3:30am vomiting-multiple times and loose stool elimination/turning to diarrhea continued chills and inability to warm up hands and feet complete fatigue Continued muscle pain/joint pain and injection site pain/swelling Mar 30 2:30pm Low grade fever (99.8) all other symptoms remain and limbs begin to warm up Slept from Mar 30th @ 7pm-Mar 31st-7am Mar 31 Woke at 7am and felt much better Injection site on arm still tender, but improving Fever gone/temperature normal (97.5) rash dissipated Joint and muscle pain lingering (reported side effects to Pfizer reporting mid day of Mar 30
52 2021-03-31 swelling Lightheaded, dizziness, tongue tingling and "feels" inflamed (I am able to swallow. I have had burn... Read more
Lightheaded, dizziness, tongue tingling and "feels" inflamed (I am able to swallow. I have had burning mouth syndrome for the past 3 years due to menopause it seems to be worse since the vaccine), tinnitus (also a preexisting condition but seems worse since vaccine)
52 2021-04-02 lymph node swelling She had an allergic reaction; swelling underneath her arm in the lymph node; Injection site swelling... Read more
She had an allergic reaction; swelling underneath her arm in the lymph node; Injection site swelling; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old female patient received the second dose Pfizer BioNtech COVID 19 vaccine (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number EN6201), Injected in left arm unsure if given in muscle, on 09Feb2021 15:17 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. First dose of Pfizer COVID 19 vaccine given on 19Jan2021, Lot EL3247, injected on left arm and unable to confirm if intramuscular. Patient reported that after COVID 19 vaccine second shot she had an allergic reaction and got it done late afternoon on Tuesday. The lymph node under he left arm pit is completely swollen and has been since yesterday early Wednesday (10Feb2021) morning around 04:30. The injection site also swelled up immediately (09Feb2021 15:17). She had all the other stuff too, but she is only concerned about these two. The outcome of the event swelling underneath her arm in the lymph node was not recovered, event Injection site swelling was recovering. and the outcome of the event hypersensitivity was recovered. No further details provided.
52 2021-04-02 peripheral swelling Itching, redness, swelling of palms
52 2021-04-03 lymph node swelling, neck mass I have a large lump on the lower portion of my neck on the same side as my shot was administered; Mo... Read more
I have a large lump on the lower portion of my neck on the same side as my shot was administered; Most likely lymph node very swollen.; This is a spontaneous report from a contactable 52-year-old female consumer reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9264) via an unspecified route of administration from 02Feb2021 at 08:30 am to 02Feb2021 at 08:30 am at single dose on left arm for covid-19 immunization. Patient was 52 years old and not pregnant at the time of vaccination. Patient's medical history included allergies to medications, food, or other products; Cipro and Keflex (dates unspecified). Historical vaccine included (other vaccine 4 weeks details, Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine; yes) BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL0142) via an unspecified route of administration from 12Jan2021 to 12Jan2021 at single dose on left arm for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as other. Concomitant drugs (List of any other medications the patient received within 2 weeks of vaccination: No) were not reported. Patient reported that on 04Feb2021 at 04:00 pm ‘'I have a large lump on the lower portion of my neck on the same side as my shot was administered. It is about the size of two grapes. Most likely lymph node very swollen. Treatment received for the adverse event was reported as no. The reported events were considered as non-serious (serious; no, seriousness criteria-results in death; no, seriousness criteria-life threatening; no, seriousness criteria-caused/prolonged hospitalization; no, seriousness criteria -disabling /Incapacitating; no, seriousness criteria-congenital anomaly/birth defect; no). Prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, has the patient been tested for COVID-19 was reported as no. The outcome of events was recovering.
52 2021-04-03 swelling noticed a painful lump, the size of a small grape above the left medial clavicle, within the supracl... Read more
noticed a painful lump, the size of a small grape above the left medial clavicle, within the supraclavicular cervicle triangle; noticed a painful lump, the size of a small grape above the left medial clavicle, within the supraclavicular cervicle triangle; woke up with swelling; This is a spontaneous report received from a contactable consumer. A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6199), via an unspecified route of administration administered in left arm on 05Mar2021 14:30 (at the age of 52-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a hospital. No other vaccine in four weeks. Medical history included eczema and known allergies: gluten, dairy and soy sauce. The patient had no concomitant medications. The morning of 13Mar2021 at 05:00, the patient woke up with swelling and noticed a painful lump, the size of a small grape above the left medial clavicle, within the supraclavicular cervicle triangle. It was still with the patient and she was about to see her doctor today. No treatment was received for the events. The patient had no covid prior vaccination and was not covid tested post vaccination. The outcome of the events was not recovered.
52 2021-04-04 lymph node swelling Sore Arm immediately. Body aches, chills, sweats, high blood pressure 156/105, sore joints, severe h... Read more
Sore Arm immediately. Body aches, chills, sweats, high blood pressure 156/105, sore joints, severe headache, nausea, swollen glands in neck and under arm pits and in breasts, could not lift arms without pain, walking hurt, swallowing hurt, chest and ribs hurt to breathe, insomnia, jitters, entire body was in pain, every ounce of my body and it hurt to even roll over in bed or get up and walk. This lasted for 5 days in a row and started the evening that I got the shot. I was perfectly well before the shot.
52 2021-04-04 peripheral swelling, swelling face swelling in face and hands--cannot make a fist without pain
52 2021-04-04 peripheral swelling Swollen hands and feet, high blood pressure, jitters, insomnia for 7 days.
52 2021-04-04 peripheral swelling Three hours after the injection of the 2nd dose, the right leg became swollen at a noticeable differ... Read more
Three hours after the injection of the 2nd dose, the right leg became swollen at a noticeable difference compared to the left leg. Extreme swelling around the ankle and the knee. Blood pressure at 136/83 and rate at 82 at 2pm. Doctor called and advised to go to the ER. Arrived at the ER and they reviewed vitals and discharged as they found a round red 1mm dot on the ankle and believed that a bug bit me shortly after the injection was given. It was possible a small gnat (no-see-ums) may have bit me as I did look down to scratch when I saw the swollen leg.
52 2021-04-05 lymph node swelling Tired, muscle aches (treated with Tylenol and gone in a day); swollen lymph nodes in left armpit (Ov... Read more
Tired, muscle aches (treated with Tylenol and gone in a day); swollen lymph nodes in left armpit (Over a week so far, treating as needed with Advil)
52 2021-04-05 swelling Immediate local itching, redness, swelling.
52 2021-04-06 anaphylactic shock Severe anaphylactic shock reaction. Hives, throat swelling, breathing affected, blood pressure spike... Read more
Severe anaphylactic shock reaction. Hives, throat swelling, breathing affected, blood pressure spiked 178/118, dizzy / lightheaded.
52 2021-04-06 peripheral swelling At 4am the day following the shot I woke up diarrhea, vomiting, a fever (101.4), chills/sweating, sq... Read more
At 4am the day following the shot I woke up diarrhea, vomiting, a fever (101.4), chills/sweating, squeezing chest pain, tightness in throat, swelling of hands/feet, joint pain and throbbing headache- by later in the day I had also developed a blister type rash on my upper butt crack. I got the shot on Weds- symptoms finally subsided by Sunday evening except the rash which on Sunday had crusted over and is now/currently dark red, flat and feels sore/tingly. I'm currently waiting f or a return call from my doctors office about how to treat the rash. This rash looks very similar to shingles. My 18 yr old daughter got the shot one day before me and has this same rash on her cheek.
52 2021-04-06 swelling face, peripheral swelling fainting; dizzy; tachycardia; high blood pressure; then numbness to left side of face swelling then ... Read more
fainting; dizzy; tachycardia; high blood pressure; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; This is a spontaneous report received from a contactable nurse (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 12Mar2021 at 09:30 (at the age of 52 years) at a single dose in the left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 12Mar2021, the symptoms the patient had were fainting, feeling dizzy, tachycardia, high blood pressure, then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head. The events resulted to doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any treatment for the events (as reported). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequel in Mar2021. Information on the lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to event fainting cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-04-07 lymphatic obstruction I had severe pain under my arms and in my chest area. I have severe swelling under both arms, espec... Read more
I had severe pain under my arms and in my chest area. I have severe swelling under both arms, especially my left arm. (Lymphedema). I had severe fatigue, nausea, headache, fever, and aches.
52 2021-04-07 swelling face, anaphylactic reaction I had an allergic reaction (anaphylactic) after both shots, Doses 1: I had taken Claritin the night ... Read more
I had an allergic reaction (anaphylactic) after both shots, Doses 1: I had taken Claritin the night before, I received the vaccine at 4:00 PM and I had red, hot and inflammation on my face 11 min before the shot, they let me in observation for 30 min. Doses 2: it was at 9:15 Am, I had taken Claritin the night before and 1 Benadryl 30 min before shot, I took another Benadryl just before vaccination and had allergic reaction (mild red, hot, and inflammation on my face) just few seconds after second shot, they let me in observation for 30 min. 3 hours after second shot, I had again allergic reaction: red, hot, and inflammation on my face, I took 2 Benadryl.
52 2021-04-08 anaphylactic reaction Anaphylaxis fast heart beat sob like being on fast treadmill tongue swelling super high blood pressu... Read more
Anaphylaxis fast heart beat sob like being on fast treadmill tongue swelling super high blood pressure the next two days after I had really bad migraine and high fever of 102.3° with bad fatigue for 4 days.
52 2021-04-08 lymph node swelling, lymph node pain Lymph node in left axillae swollen, "about the size of a lemon". Painful to the touch.
52 2021-04-08 peripheral swelling 1159-Vaccinated . 1215- C/o swollen hands and headache` 1235-Symptoms improved. Allergist on call ... Read more
1159-Vaccinated . 1215- C/o swollen hands and headache` 1235-Symptoms improved. Allergist on call notified. Recommended PO Benadryl. Ok to take at home.
52 2021-04-09 peripheral swelling 4/9 4:25pm: runny nose, headache, stuffy sinuses/pain- went away after 15 minutes 4/9 11:06pm: woke... Read more
4/9 4:25pm: runny nose, headache, stuffy sinuses/pain- went away after 15 minutes 4/9 11:06pm: woke up to speeding heart rate, labored breathing, thumb joint left hand hurts/pain, stomach nausea, racing in stomach, neck itchy, pin prickly hands and legs 4/10 4am: hand joints very stiff, can?t close hands, fingers extremely swollen and painful, injection site - severe pain, thirsty, dehydrated 4/10 7am: neck severely itchy, hands feels like they?re going to explode from pressure- swelling and red with pain, severely dehydrated, coated tongue and disgusting taste in mouth, feel nauseous, multiple head spasms continuing at approximately 15 min intervals, scalp itchy, pain at injection site
52 2021-04-09 peripheral swelling Severe joint pain and swelling in fingers.
52 2021-04-10 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Severe
52 2021-04-10 lymph node swelling swollen lymph node, right lower base of the neck, anterior to the clavicle, pea to peanut-sized
52 2021-04-11 peripheral swelling Felt arm slightly cold running down toward fingers. Slight nausea. Arm became progressively painful ... Read more
Felt arm slightly cold running down toward fingers. Slight nausea. Arm became progressively painful from site of injection down to fingers. Unable to sleep, swelling along arm down to fingers. Swelling going down very slowly, can now bend elbow and make fist but still painful if used.
52 2021-04-11 swelling, lymph node swelling Rash - started as warm raised area on right shoulder just above scapula near neck, mild itchiness, b... Read more
Rash - started as warm raised area on right shoulder just above scapula near neck, mild itchiness, burning, aching. Developed low grade fever, swollen/hard lymph nodes in my neck, rash resembled ringworm at first, now has scabbed areas where blisters would be, painful. I have never had chickenpox, was vaccinated as a child and titers show positive for immunity. I was diagnosed as having shingles at urgent care, and currently taking PO valacyclovir. I received the 2 nd dose of pfizer vaccination on 2/24/2021 and developed first sx approximately 4/6/21
52 2021-04-12 lymph node swelling Sore throat, fatigue, body aches, fever, swollen lymph nodes - bilateral neck, night sweats, diarrhe... Read more
Sore throat, fatigue, body aches, fever, swollen lymph nodes - bilateral neck, night sweats, diarrhea.
52 2021-04-12 lymph node swelling Within 15-20 minutes of receiving vaccine, I felt something in my chest. A slight pain or pang for a... Read more
Within 15-20 minutes of receiving vaccine, I felt something in my chest. A slight pain or pang for a few seconds then it went away. The next day, I had noticeable visible swelling of my left breast and lymph nodes under my left armpit even though injection was on rt arm. This was checked out by radiologist with a mammogram/ultrasound and lefts side looked fine, right side was suspicious of a legion which was biopsies and turned out to be fibrosis. Don?t know if there?s a connection to vaccine or not. What was equally if not more concerning were the chest pains which returned a few more times getting stronger that first week after the vaccine. It was a pulling sensation on the left side of my chest that, if 10x stronger, would feel (or be?) a heart attack. And that was after the 1st dose, so I am extremely hesitant to take the 2nd dose should those particular side effects intensify. I have googled it and can find no information about chest pains after the vaccine. On a side note, my first cousin went into cardiac arrest after receiving his vaccination. He was dead and they brought him back. I?d like to avoid this.
52 2021-04-13 swelling face Facial swelling, throat irritation, weakness, profuse sweating.
52 2021-04-13 white blood cell count increased PT VOICED SHE TOOK PFIZER VACCINE THIS PAST FRIDAY (4/9/21). LATER THAT EVENING SHE BEGAN HAVING COV... Read more
PT VOICED SHE TOOK PFIZER VACCINE THIS PAST FRIDAY (4/9/21). LATER THAT EVENING SHE BEGAN HAVING COVID-LIKE SYMPTOMS AND RIGHT SIDE CHEST PRESSURE (ON/OFF). ON 4/12/21 SHE BEGAN HAVING NAUSEA AND VOMITING AND COULDN'T KEEP ANYTHING DOWN SO SHE DECIDED TO CALL HER PCP. SHE WAS ADMITTED TO THE HOSPTIAL ON 4/13/21. PT VOICED SHE DIDN'T HAVE ANY PROBLEMS OR SYMPTOMS BEFORE SHE RECEIVED THE VACCINE.
52 2021-04-14 anaphylactic reaction Patient received 2nd Pfizer dose at 10:00 am. She left the facility after 15 minute wait time. Wit... Read more
Patient received 2nd Pfizer dose at 10:00 am. She left the facility after 15 minute wait time. Within the next 5 - 10 minutes she became SOB with respirations 40 per minute. She was taken to Medical Center and seen by 10:45 - 11:00 am. She was treated for anaphylaxis and was worked up for any other underlying problems. She had to be put on the vent due to acute respiratory failure. She was negative for COVID, pulmonary emboli and pneumonia. As her status declined, ED felt she needed higher acuity care. She was over the weight limit to be airlifted so she was transported by critical care ambulance to hospital where she is in ICU and on ventilator.
52 2021-04-14 lymph node swelling Low grade fever , malaise, fatigue, nausea, swollen lymphnodes in collarbone area, swollen arm at in... Read more
Low grade fever , malaise, fatigue, nausea, swollen lymphnodes in collarbone area, swollen arm at injection site. Rash at injection site, headache , chills , body and joint ace and pain
52 2021-04-14 oral herpes Little tiny cold sores in mouth.
52 2021-04-14 peripheral swelling Swelling of feet, hands,intense itch of hands, major hives, swelling in lips.
52 2021-04-14 peripheral swelling 04.06.21 I received my 1st Pfizer shot at 3pm. At 5pm, I had a headache, my neck was hurting and I b... Read more
04.06.21 I received my 1st Pfizer shot at 3pm. At 5pm, I had a headache, my neck was hurting and I began feeling so weak I could barely talk, I couldn't hold my eyes open. I took 3 Aleve. At 8pm, I started with shortness of breath just going downstairs plus my entire body felt like I was hit by a truck. My 3lb. Chihuahua would get on me and it felt like I was hit by a bat with a ripple effect into the surrounding area. I took 2 Tylenol PMs. On 04/07, at 6am, I woke up to my limbs extremely swollen and throbbing, this included both feet and especially both wrists and hands. My hands were worse than my feet. My left wrist/hand also had tingling. I was so weak I could barely get out of bed or talk, this continued through to 5:30pm same day. I called an Urgent Clinic and told her all my symptoms, she said were all "normal" until I got to my wrists/hands and limbs. Urgent Care told me it would be best to be seen in ER and evaluated. I immediately went to ER . This approximate time was 6:30pm on 04/07/21.
52 2021-04-14 swelling face Patient developed rash and swelling to the face approximately 15 minutes after 2nd covid vaccine was... Read more
Patient developed rash and swelling to the face approximately 15 minutes after 2nd covid vaccine was given. Prior to vaccine, she stated to pharmacist she had swelling at the injection site after first vaccine which is a typical reaction and it was decided to proceed since she did not have an allergic type reaction. Patient was given 50 mg of liquid Benadryl and asked to remain in the waiting area for an additional 15 minutes for observation with additional check ins. She did not want to seek additional medical attention and did not want us to call emergency services. Her throat and breathing was not obstructed. Her son was available to drive her home. She stated she did not have any questions or concerns at this time.
52 2021-04-16 lymph node pain Severe headache, nausea, dizziness, fever and sore lymph nodes started less than 24 hours after 1st ... Read more
Severe headache, nausea, dizziness, fever and sore lymph nodes started less than 24 hours after 1st dose and have continued since. On day 7 at the time of reporting this and still having side effects
52 2021-04-18 swelling face Similar to after first vaccination, I felt quite sick the next day with fever, body aches, fatigue, ... Read more
Similar to after first vaccination, I felt quite sick the next day with fever, body aches, fatigue, etc. I had COVID in March 2020, and it felt similar. I recovered in 24 hours, faster after second vaccine than first. But then Thursday night I developed hives on my inner arms. On Friday morning I woke up and my bottom lip was swollen in one corner. Swelling became worse. I took antihistamine, which seemed to help, and consulted with my doctor. But as the day continued my face became splotchy, my cheeks swelled and warm to touch, and the swelling moved to my upper lip. That evening the swelling became extreme. My doctor put me on prednisone. Next day swelling was reduced. By Sunday morning there was just slight swelling in face. By later Sunday swelling was gone. I also submitted a report after my first vaccination, which included warmth at vaccination site and rash on arm. And two days of feeling like I had COVID again.
52 2021-04-19 herpes virus infection Herpes Flare-up
52 2021-04-19 lymph node swelling On Friday 4/16/21 evening, I had my left tonsil spontaneously rupture without any provocation. I was... Read more
On Friday 4/16/21 evening, I had my left tonsil spontaneously rupture without any provocation. I was not eating or drinking but felt like I had something in my throat. I coughed it into a tissue, and it was a blood clot the size of a nickel. My tonsil had 2 places that it was oozing blood and continued to bleed for about 1.5 hours. It eventually tapered off and the redness/bruising disappeared over the next 48 hours. There was no pain, no warning - just a mouth full of blood. The tonsil that ruptured was on the same side as where I received the injection and I had swollen lymph nodes under my arm on that same side until Sunday 4/18. I can't help but think it was related to the vaccine as I had no other cold/hay fever/allergy symptoms of any kind to explain a bleeding tonsil.
52 2021-04-19 peripheral swelling my elbow got warm after shot, then day and a half later was the size of a golf ball, was also greeni... Read more
my elbow got warm after shot, then day and a half later was the size of a golf ball, was also greenish. still swollen but trying to nurse it back to normal. also my hands and toes are swollen.
52 2021-04-19 swelling face Swollen on my face ,
52 2021-04-19 swelling face Fever 100.5 - 102.00 4/16, 4/17, 4/18, Fatigue, body pain, nausea, headache 4/16, 4/17,4/18. Fatigu... Read more
Fever 100.5 - 102.00 4/16, 4/17, 4/18, Fatigue, body pain, nausea, headache 4/16, 4/17,4/18. Fatigue, body pain, nausea, facial / eye swelling, pain when walking in lower back and hamstrings 4/19, 4/20
52 2021-04-19 swelling, lymph node swelling, lymphatic obstruction Gradually over the last several weeks I have developed all over body swelling, lymphedema triggered,... Read more
Gradually over the last several weeks I have developed all over body swelling, lymphedema triggered, nodules under my arm, pressure on my chest, difficulty catching my breathe, out of breathe walking or even doing nothing, tired, elevated heart rate
52 2021-04-20 lymph node swelling 4/4/2021 - 4/7/2021 - Low fever (99.9 degrees), but oddly only in evening and overnight; severe enou... Read more
4/4/2021 - 4/7/2021 - Low fever (99.9 degrees), but oddly only in evening and overnight; severe enough to disrupt sleep - took Tylenol 4/5/2021 - 4/14/2021 - Two canker sores appear suddenly on my bottom inside lip on the left on 4/5;extremely dry mouth; tongue is swollen and pale; feels like I have cuts on my tongue; constantly drinking water; swollen tender lymph nodes all along the left side of the neck; sores in the back left side of tongue on 4/6. Took Advil intermittently, didn't reduce swelling of either the nodes or tongue, but helped with pain. 4/5/2021 - 4/10/2021 - Fatigue, aches, and chills through these days; took nap in the afternoon on Saturday 4/10 and suddenly felt much better after 4/8/2021 - lost taste for just one day; couldn't taste sweet in the morning and then couldn't taste salty in the afternoon 4/15/2021 - 4/21/2021 - canker sores and "cuts" on tongue reducing over these days; when I look at these sores/cuts on my tongue, I can't really see any cuts or sores...just looks like little bumps or swollen taste buds 4/15/2021 - 4/18/2021 - Lymph nodes on left side of neck still swollen but no longer tender and painful 4/15/2021 - 4/19/2021 - Severe headaches that made me take two Advils every 4-6 hours. Touching hair was sensitive and coughing or sneezing really hurt. 4/19/2021 - 4/20/2021 - Number of swollen lymph nodes slowly reduced in number; not painful. 4/20/2021 - Mostly feel good. No more headaches. Tongue just had two places where it felt like it was cut. Again, can't really see anything wrong when I looked at it. 4/21/2021 - Today I was mostly good. Just only one small swollen lymph node at base of neck on left side (not painful); one "cut" on the tip of my tongue on the left (little painful).
52 2021-04-20 oral herpes, swelling face Pfizer-BioNTech COVID-19 Vaccine EUA - 1st day severe arm pain on left side - Took 800 Mg Ibuprofren... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - 1st day severe arm pain on left side - Took 800 Mg Ibuprofren. 2nd day - severe chills, trouble breathing, intense dry heaves, could not keep down water without vomiting, intense muscle pain, intense fatigue, fever. Took 250 mg of tylenol later in the evening after able to hold down water. Left side of body still sore and face swelling on left side. 3rd day - nausea, severe headache - took 250 mg Tylenol and 800 Mg Ibuprofren throughout day with no relief. Still have pain and swelling on left side of face. Injection site is bruised with redness around and very sensitive to touch. Today (Day 4) - still have headache, face swelling on left side, fever blisters on lower lip, nausea, left side soreness and left arm still sore.
52 2021-04-20 sepsis COVID pneumonia; Hematological; bleeding; having hemoxysis; slight troponin increase; GI bleed; head... Read more
COVID pneumonia; Hematological; bleeding; having hemoxysis; slight troponin increase; GI bleed; headaches; COVID-19 test was positive; COVID-19 test was positive; nauseous; abdominal discomfort; body aches; This is a spontaneous report from a contactable physician. A 52-year-old female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age 52-year-old on 12Mar2021 at single dose for COVID-19 immunisation. Medical history included hemodialysis for many years, adherent to medical care, multiple DVTs and Pes (On anticoagulants), morbid obesity, Patient was on dialysis for renal failure and had lupus anticoagulant (positive), Afib, allergic to shellfish. Family history included renal failure and had lupus anticoagulant. Concomitant medications included warfarin sodium (COUMADIN); metoprolol; amitriptyline; calcitriol; ergocalciferol (VIT D); calcium; calcium acetate (PHOSLO); amiodarone; albuterol. The patient previously allergic to Cipro, clindamycin, doxycyclin, Lyrica, tetracycline. The patient previously was non-responder to hepatitis B vaccine. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 for COVID-19 immunisation. The patient hasn't been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient wasn't smoker/ former smoker. There was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. A nephrologist who reported patient in her hemodialysis unit who were vaccinated with BNT162b2 but were recently diagnosed with COVID-19. More detail is below on each patient. The patient COVID results were sent to the local health department for genetic sequencing (pending) and SARS titers were drawn (pending). Unfortunately, the HD unit does not have B/L information (although the B/L # was put on the patient's COVID vaccine cards, a record was not kept in the HD unit). Day she came in for dialysis she was already short of breath she said she'd had body aches for 5 days, got short of breath on 05Apr2021. The day before, started getting cough, nauseous, chills, abdominal discomfort on 04Apr2021. The patient was sent to the ER from dialysis and was admitted for SOB on 05Apr2021 and passed away on 09Apr2021 due to a GI bleed. Patient is over 500lbs so was unable to fit into hospital imaging equiment for CT scans or weight measurements. COVID-19 test was positive on 05Apr2021; the patient experienced COVID pneumonia on 05Apr2021. The patient admitted on 05Apr2021 to regular floor. The patient was moved to an Intensive Care Unit on 06Apr2021. The patient experienced short of breath on 05Apr2021 and required much more O2 than normal. Sometimes required BP support while on Dialysis and BP was 113/61 in ER. Pressure dropped to 100/70 and required mitrodrine after fluid was removed. The patient needed 4 liters supplemental O2 vs. only needing 2 liters at home. The patient experienced tachypnea and hypoxemia and no Respiratory failure. Respiration was 22. After 5 litres of O2 improved. Pulse 93 in ER. Cardiovascular: There was no heart failure, cardiogenic shock, Acute myocardial infarction, arrhythmia and myocarditis. The patient Had chest pain which resolved when O2 was administered. Gastrointestinal/Hepatic: There was no Vomiting, Diarrhea. The patient experienced nausea but no vomiting or diarrhea and complained of abdominal pain. There was no Jaundice and acute liver failure. Neurological: There was no altered consciousness, altered consciousness, encephalopathy, meningitis and cerebrovascular accident. The patient had headaches a couple days before admitting to ER. Hematological: There was no Thrombocytopenia, Disseminated intravascular coagulation. INR was 3 due to large dose of coumadin, and platelets were 180 and white count 6.8. Slight troponin increased at 0.37 at admittance, BNP 39. The patient started coughing up blood, having hemoxysis and bleeding on unspecified date. Laboratory test or diagnostic studies was reported that test for SARS-CoV-2 by PCR, or other commercial or public health assay. Xray showed vascular congestion with superimposed infiltrate which could represent pneumonia. Blood count was 11 and 36.7% at ER. Clinical chemistry: Sodium was 133; BUN was 68; Creatinine was 10. Evidence of hypoxemia: Pulse oO2 was 90 in ER. CT scans: unknown results. Urinalysis: On dialysis so does not make urine. The patient had received Remdesivir, from 06Apr2021, Hydroxychloroquine/chloroquine, Azithromycin from 06Apr2021 and Corticosteroids from 06Apr2021 for COVID-19. The outcome of event "GI bleed" was fatal, the event "chest pain" and "body aches" was recovered and other events was unknown. The patient died on 09Apr2021. An autopsy was not performed. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of the suspect drug cannot be excluded for the events vaccination failure, COVID-19, COVID-19 pneumonia, and sepsis. However, the patient's multiple medical comborbidities including renal failure requiring dialysis, lupus, and morbid obesity along with the risk of COVID-19 infection in light of the current pandemic are the more likely explanations for the development of these infections. The events gastrointestinal hemorrhage, hemorrhage, hemolysis and troponin increased are attributed to intercurrent medical conditions, and are considered unrelated to the suspect drug. The patient is currently on warfarin which may increase the risk for bleeds. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: GI bleed
52 2021-04-21 lymph node swelling, swelling face On Saturday, April 3rd I got my first Pfizer Covid shot. I didn?t have any side effects like what th... Read more
On Saturday, April 3rd I got my first Pfizer Covid shot. I didn?t have any side effects like what they said could happen such as Covid symptoms. On Tuesday, April 13th, 10 days after I had gotten the shot I noticed these red marks by my eye, it was in the morning and they came out suddenly so I thought I had gotten bit by some thing. Over those previous 10 days I noticed that my hands were extremely sore but I have arthritis in my fingers and can have tightening and soreness when the weathers bad so I chalked it up to that. Even though it was worse than what it normally would be. By Friday the 16th, the reddened areas of my face were swollen, my lymph nodes in my neck and around my ear started to swell. My cheek bone,in jaw bone, and eye socket were in terrible pain. I went to medical and they thought it was a spider bite that was getting infected they put me on an anabiotic. I have pictures. Saturday the 17th I was so exhausted! I could not get off the couch. I slept all day Saturday, literally getting up to take a couple of bites of food and either laying back on the couch are going back to bed. Sunday I woke up I felt better not 100% but I had some energy. The marks on my face were no different and now they are getting more painful burning, itching, still swollen and very painful to the touch. 4/20/21 nothing has gotten better. I went to the urgent care one of the PAs said it looks like it?s shingles.
52 2021-04-22 lymph node swelling Very lare, very painful swollen lymph node in left arm pit. Still present and painful 3 days after i... Read more
Very lare, very painful swollen lymph node in left arm pit. Still present and painful 3 days after injection. Actual injection site still sore and very bruised.
52 2021-04-22 swelling face Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of ... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Symptoms began 30min after dose. pt was on way home from vaccine then went to ER for treatment. was given benadryl at hospital then released.
52 2021-04-22 swelling face Swollen lower lip-starting on the left corner Swollen Left Side Cheek and Jaw White sensitive bumps ... Read more
Swollen lower lip-starting on the left corner Swollen Left Side Cheek and Jaw White sensitive bumps on tongue Getting worse each day. Today is Friday 4/23/2021
52 2021-04-23 lymph node pain, lymph node swelling Locked jaw, swollen lymphatic gland under left arm. Very painful.
52 2021-04-23 lymph node swelling Headache and body ache, tiredness about 12 hrs after receiving 2nd dose continuing until 24 hrs afte... Read more
Headache and body ache, tiredness about 12 hrs after receiving 2nd dose continuing until 24 hrs after receiving. Swollen lymph node on injection side noticed second morning after shot administered, continued into 3rd day after 2nd dose.
52 2021-04-23 peripheral swelling Swollen right foot. The big toe is the most swollen area.
52 2021-04-23 swelling face On April 7 I felt itchy arms which I thought was related to a soap that I was using at a hotel. That... Read more
On April 7 I felt itchy arms which I thought was related to a soap that I was using at a hotel. That day around 3 PM I felt exhausted and had to lie down. The next morning I woke up With a puffy face. The next morning I woke up feeling as if my teeth had punctured my inner cheeks around my job. Friday, 9 April I was still puffy and it was more pronounced on the left side of my face. From there it gradually became more swollen over the next few days before I went to urgent care.
52 2021-04-23 swelling got up twice during the middle of the night and fell twice; flu like symptoms; body aches; joint pai... Read more
got up twice during the middle of the night and fell twice; flu like symptoms; body aches; joint pain; headache; stinging; swelling; redness at injection site; tiredness; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number unknown, Expiration date unknown), via an unspecified route of administration in right arm on 08Feb2021 at 19:30 at a single dose for covid-19 immunization at Hospital. The patient's medical history and concomitant medications were not reported. NDC number of COVID-19 vaccine was unknown. On 08Feb2021, the patient experienced stinging, swelling, tiredness and redness at injection site. The tiredness started last night at 9pm. She had been sleeping on and off ever since. She took Benadryl at 08 p.m. last night and it went away. On 09Feb2021, she had body aches, headache and joint pain. She has had flu like symptoms since. She has had body aches and tiredness. She hasn't had a high fever. She was in bed. She got up twice during the middle of the night and fell twice because of the joint aches. She lost her balance. Her joints just gave out. She was steady on her feet. She was just slow. She was not taking Benadryl now. She just had ice on the back of her neck, and it was working. The headache was manageable without medication and ice. Therapeutic measures were taken as a result of stinging, swelling, and redness at injection site. The reporter classified the events as non-serious and assessed the causality between the event and the vaccines as related. The outcome of events stinging, swelling, tiredness and redness at injection site was recovered on 08Feb2021, outcome of body aches was recovering and outcome of other events was not recovered.
52 2021-04-24 anaphylactic reaction allergic reaction (anaphylactic); This is a spontaneous report from a contactable pharmacist (patien... Read more
allergic reaction (anaphylactic); This is a spontaneous report from a contactable pharmacist (patient). A 52-years-old female patient received second dose of BNT162B2 (BNT162B2), Via an unspecified route of administration, administered in Arm Right on 05Apr2021 09:15 (Batch/Lot Number: ER8737) as single dose for covid-19 immunisation. Medical history included hypersensitivity. There were no concomitant medications. The patient experienced allergic reaction (anaphylactic) (anaphylactic reaction) on 05Apr2021 09:15 few seconds after the second dose had taken Claritin the night before both shots and Benadryl 30 min before and on 2nd shot. 3 h later the reaction repeated and I took 2 more Benadryl Therapeutic measures were taken as a result of allergic reaction (anaphylactic) (anaphylactic reaction). The patient had recovered from the events. No follow-up attempts are possible. No further information is expected. .; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event anaphylactic reaction and the suspect vaccine BNT162B2.
52 2021-04-24 lymph node swelling, peripheral swelling had pain and soreness in the arm which has subsided now; There's a bump which is extremely sensitive... Read more
had pain and soreness in the arm which has subsided now; There's a bump which is extremely sensitive and is swollen; her hands had gotten puffy; injection site soreness in her left arm; pain in between my knuckles on both hands; This is a spontaneous report from a contactable consumer or other non-HCP. A 52-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ER8729), via intramuscular route of administration, in left arm on 10Apr2021 04:30 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had vaccination on Saturday at 4:30 and probably about 3 hours afterwards, patient noticed her hands had gotten puffy on 10Apr2021. However, patient had pain between the knuckles of both her hands on 10Apr2021. On the left hand, right where the wrist bends, there was kind of like a bump there that is very tender and up to the pointer finger, that knuckle is very tender (of her left hand). There was a bump which is extremely sensitive and is swollen on an unspecified date. On 10Apr2021(maybe 2 hours afterwards), the patient had injection site soreness in her left arm, after four hours her arm became noticeably sore. The patient woke up this morning and had pain and soreness in the arm had subsided greatly on an unspecified date, the soreness is almost gone. The pain with the bending of her wrist and the knuckle joint to her pointer finger on the left hand was staying the same. On 11 Apr 2021(yesterday), this pain came on noticed. She mentions she had not even taken her vitamins that day, she made sure she nothing prior to the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of event pain and soreness in the arm which has subsided now recovered on an unspecified date in 2021, outcome of pain in between my knuckles on both hands and her hands had gotten puffy was not recovered, outcome of there's a bump which is extremely sensitive and is swollen was unknown whereas outcome of site soreness in her left arm was recovering.
52 2021-04-26 lymph node swelling Severe body ache, itching rash, armpit swelling, breast pain, muscle pain, fever, chills, bone and j... Read more
Severe body ache, itching rash, armpit swelling, breast pain, muscle pain, fever, chills, bone and joint pain.
52 2021-04-26 oral herpes Within 2 days of my first covid vaccine, I had an outbreak of a herpes cold sore on mouth (HSV1) and... Read more
Within 2 days of my first covid vaccine, I had an outbreak of a herpes cold sore on mouth (HSV1) and genital area (HSV2). Lasted about a week. Before this outbreak, I had not had any outbreaks of HSV in 5 years. This outbreak was only the third outbreak I have had in my lifetime. I received my second Covid vaccine on 3/17/21. About 2 or 3 days later, the same reaction occured. I developed an outbreak, just like after my first Covid vaccine.
52 2021-04-26 peripheral swelling Swelling in right arm has not gone away. I now have to see a specialist and get x-ray and MRI to fin... Read more
Swelling in right arm has not gone away. I now have to see a specialist and get x-ray and MRI to find out why the swelling persists after having my first covid shot. I had the second shot with little adverse effects.
52 2021-04-26 swelling face 4/15/2021 I received the first Pfizer Covid 19 shot. 4/16/021 woke to find red rash at injection sit... Read more
4/15/2021 I received the first Pfizer Covid 19 shot. 4/16/021 woke to find red rash at injection site. 4/16/2021 at 10:30 am, left arm began to itch at injection site. No additional rash detected. At 6:00PM on 4/16/2021 I began to swell just under my left eye. By 10:00 pm both eyes and forehead had become swollen. Took two Bendadryl thinking that would help. By 8:00 am 4/17/2021 both eyes became nearly swollen shut and swelling had moved to upper lip. Went to ER. ER doctor on call prescribed a steroid shot and oral steroids to take starting the next day. Rx was for (3) 20mg prednisone 1x a day for 4 days. Sunday evening 4/18/2021 still had some swelling in face. Monday, minimal swelling in eye lids. I supplemented Cont'd: I also took Benadryl every 5-6 hours around the clock for four days (from 4/17/2021 - 4/20/2021) which seemed to help minimize the swelling. I also had significant flushing (redness) in my face from 4/17/2021 - 4/21/2021. On Wednesday 4/21/2021 I contacted my General Practitioner for a follow up appointment. During that visit, he said that it would not be good for me to get any further Covid 19 shots. I have canceled my appointment for the second shot. At this time, I have not had any additional side effects but, I will be monitoring over the course of the next several months.
52 2021-04-26 swelling Pfizer dose1 Neck pain, shoulder pain swollen collar bone area, cysts on left , pain in left arm, ex... Read more
Pfizer dose1 Neck pain, shoulder pain swollen collar bone area, cysts on left , pain in left arm, extremely fatigued. Body aches, zeo energy, malaise
52 2021-04-27 swelling face abrupt onset of abdominal pain that caused her to go home from work. The following morning at 5:30 ... Read more
abrupt onset of abdominal pain that caused her to go home from work. The following morning at 5:30 a she woke up with a swollen face, lips, periorbital region. No swelling of tongue, uvula or pharynx. Urticaria on arms. Resolved without therapy within 8 hours. Advised to NOT take ANY aspirin products and to stop losartan.
52 2021-04-27 swelling face Nose and throat feeling swollen. EMS at side.
52 2021-04-27 swelling Had small red area that started on 04/24/21 but then on 04/27/21 area became inflamed like a welt an... Read more
Had small red area that started on 04/24/21 but then on 04/27/21 area became inflamed like a welt and doubled in size. By end of day on 04/27/21 area was even more inflamed and itchy. By morning of 04/28/21 area has tripled in size though not itching as of now. Area is also warm to touch and is somewhat painful if pressed on. Area is also no completely circular as it is spreading to about the size in uneven circumference the size of a baseball. I am on daily antihistamines once daily but on 04/27/21 took it a second time. This did take away the itching but has not reduced the size of the rash/redness/swelling.
52 2021-04-28 lymph node swelling, lymph node pain Extreme fatigue, headache, muscle aches, lymph node pain and swelling under left arm
52 2021-04-28 peripheral swelling pt says she developed body aches and pains, dizziness, extreme fatigue, chills. She was lightheaded... Read more
pt says she developed body aches and pains, dizziness, extreme fatigue, chills. She was lightheaded and the fatigue was so bad that she felt like she had been drugged. Her right arm and hand were swollen and painful. There was a large knot around the injection site. The pain and swelling in right arm affected her mobility to work. Large varicose veins appeared on her forehead. These symptoms lasted about 4 days. She is better but says she still get large veins that appear on her forehead from time to time.
52 2021-04-28 peripheral swelling blood clot; swelling and pain in right leg; swelling and pain in right leg; right arm hurting tremen... Read more
blood clot; swelling and pain in right leg; swelling and pain in right leg; right arm hurting tremendously; This is a spontaneous report from a contactable Nurse. A 52-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Apr2021 13:45; at the age of 52-years-old, (Batch/Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypertension, ongoing memory impairment (She states that she was diagnosed either last year or the year before that she can't remember. She states that it is ongoing, but it is well controlled). Historical vaccine included vaccine to tetanus (About 3 or 4 years ago). There were no concomitant medications. The patient experienced blood clot (thrombosis) (disability) on 13Apr2021 with outcome of not recovered, swelling and pain in right leg (disability, medically significant) on 09Apr2021 with outcome of not recovered, right arm hurting tremendously (disability) on 01Apr2021 with outcome of recovered on 04Apr2021. The patient underwent lab tests and procedures which included ultrasound scan: positive on 13Apr2021 had a blood clot. Therapeutic measures were taken as a result of blood clot (thrombosis) included Xarelto and due to pain in extremity the patient received ibuprofen (7 ibuprofen every day); Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Thrombosis. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
52 2021-04-28 peripheral swelling within 15 minutes she developed lingering headache, major body aches, some chills and was light head... Read more
within 15 minutes she developed lingering headache, major body aches, some chills and was light headed. She became very fatigued. Her right arm was swollen and painful. Her symptoms lasted 3 days.
52 2021-04-29 lymph node swelling Rash, swelling at injection site , swelling in arm pit , swelling in right ear and throat. Tylenol a... Read more
Rash, swelling at injection site , swelling in arm pit , swelling in right ear and throat. Tylenol and ice
52 2021-04-29 swelling Painful arm, swelling, low grade fever, tired, itching
52 2021-04-29 swelling Lump in chest area day after vaccine that has not gone away.
52 2021-04-30 anaphylactic reaction Anaphylaxis - 50mgs benadryl , received 2 shots epinephrine, received succinate and methylPrednisolo... Read more
Anaphylaxis - 50mgs benadryl , received 2 shots epinephrine, received succinate and methylPrednisolone
52 2021-05-01 high blood cell count, white blood cell count increased 52F with no known PMH developed progressive chest pain on 4/30/2021, admitted to Medical Center 5/2/... Read more
52F with no known PMH developed progressive chest pain on 4/30/2021, admitted to Medical Center 5/2/2021 and found with NSTEMI with 95% proximal LAD occlusion w/ moderate thrombus successfully treated with drug-eluding stent x1. Pt received Pfizer vaccine #1 on 4/29. Of note, pt has not seen a doctor in several years, but labs notable for leukocytosis (WBC 14.0), polycythemia (Hgb 16.9) and thrombocytosis (PLT 959) concerning for undiagnosed polycythemia vera. If so, it is not clear whether her NSTEMI was a coincidence or whether the vaccine increased her risk of thrombosis.
52 2021-05-01 lymph node pain 3 days after shot, I experienced severe chest pain & shortness of breath which worsened when standin... Read more
3 days after shot, I experienced severe chest pain & shortness of breath which worsened when standing, and became so severe that I could not stand up. I remained laying down and after 6-8 hrs I could sit up and felt better throughout the remainder of the day. The following day I experienced pain in the lymph nodes in & under the armpit. The pain has mostly dissipated but tenderness still remains. It is worse under the left arm. I am concerned about the 2nd shot this week, Tues. 5/4.
52 2021-05-01 swelling face, anaphylactic reaction, peripheral swelling 2nd Anaphylactic episode resulting from vaccine shot 1. Tingling, itchy and swelling tongue and mout... Read more
2nd Anaphylactic episode resulting from vaccine shot 1. Tingling, itchy and swelling tongue and mouth. Throat constriction. Extreme swelling in face, right (non-shot arm), and 10 fingers. plus extreme joint pain, splotchy red- sunburn like rash on abdomen and legs, Self-administered 50 mgs of Benedryl and Epipen. Called Ambulance for emergency transport from home to hospital. Hospital administered tylenol and methylPREDNISolone sodium succinate.
52 2021-05-03 swelling face, swelling 0n 4-23-21 I was going to sleep when my arms started burning then my legs, my face and upper chest. ... Read more
0n 4-23-21 I was going to sleep when my arms started burning then my legs, my face and upper chest. I had a rash, swelling and redness that started in my arms to finally my head. It burned like I was on fire and my heart was racing more than usual. I put wet towels on my arms, legs and face. Took benadryl and after 4 hours took zyrtec. It took 4 hours for swelling to go away and the rest of the night for the redness to go away. I have taken either Benadryl or Zyrtec each day as I can feel the urge for the hot itchy stuff wanting to return. On the 27th of April I had another reaction just as described with swollen face. This time I woke up with it. Took additional benadryl with zyrtec. May 2nd had another full body rash with redness and swelling, this one went away quicker once I took benadryl. I elimanated anything new from my diet/supplements when this first happened but quickly there was not anything but my usual every day food and medication that was left to eliminate.
52 2021-05-04 lymph node swelling On April 28, (morning after the second dose) I woke up with fever, chills, & body aches; which I was... Read more
On April 28, (morning after the second dose) I woke up with fever, chills, & body aches; which I was prepared for. I didn't take any medicine--I just "toughed it out. On April 29th, the aforementioned symptoms continued, and the lymph nodes in my left armpit were swollen and sore. By April 29th, the fever & chills subsided. By April 30th the body aches were waning. The swollen and sore lymph nodes continued. By May 1, I started to develop hives on the left side of my face and neck. By May 3, the swollen sore lymph nodes had subsided, but the hives were in my hairline, across my torso, groin and legs. This is absolutely miserable. The hives are itchy, painful, and weeping.
52 2021-05-04 peripheral swelling Maculopapular rash ondorsal aspects of hands anand forearm starting 2 days after rash. Both arms swe... Read more
Maculopapular rash ondorsal aspects of hands anand forearm starting 2 days after rash. Both arms swelled up. Left arm- one which gt vaccine- had more serious symptoms. Scaling of skin subsequently with hyperpigmentation in the left forearm.
52 2021-05-05 peripheral swelling I have always had "silent" acid reflux but the day of my shot and still today, 3 full days later, my... Read more
I have always had "silent" acid reflux but the day of my shot and still today, 3 full days later, my reflux has been out of control. It is much worse than normal. This is the abnormal side effect I am reporting. I tried to Google it and see if others had this same issue. Very little is mentioned. Just minor heartburn. I also had all of the other typical side effects for the second vaccine. My arm is very sore, swollen, itchy, hot, red. I had 2 days of fatigue, tiredness, extreme body aches, joint pain, headache, nausea, diarrhea.
52 2021-05-05 swelling face Woke up the morning of April 7 with a swollen face, more pronounced on the right side, particularly ... Read more
Woke up the morning of April 7 with a swollen face, more pronounced on the right side, particularly noticeable in the right eyelid. My eye was not affected, no redness, or itching, or signs of irritation to the eye itself, just the whole right side of my face was swollen with particular focus on the eyelid. I visited my doctor on the same day and was seen by the NP who prescribed prednisone x10days. Symptoms resolved within 3 days.
52 2021-05-06 c-reactive protein increased 3 days after vaccine, I developed pins and needles/numbing in my arms, hands, legs and feet. I still... Read more
3 days after vaccine, I developed pins and needles/numbing in my arms, hands, legs and feet. I still have it today. I am continuing to go to different doctors and practitioners. Sometimes it gets a little better and then gets worse again.
52 2021-05-06 lymph node swelling, white blood cell count increased, lymph node pain, swelling 24 hours later my neck started swelling up, my left lymph node; abnormal mass in my neck which was m... Read more
24 hours later my neck started swelling up, my left lymph node; abnormal mass in my neck which was my lymph node; I developed a headache over the whole left side of my head; I could hardly move my neck; All of a sudden I kind of broke out in the sweat; Left side of my head just went totally numb; Started feeling tingling in my left hand; I went to eat some yoghurt and I could not swallow at all; Airway is being compromised by the swelling in my neck; I cannot walk my left leg is dragging, so I am lurking around having to hold on; My voice was like had to whisper; Right side of my body started shaking; Later that evening the numbness subsided. I could speak better my left lymph node was still sore; blood pressure went up; white blood cells count was really, really extremely high; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 13Apr2021 (Lot Number: EW0153), at the age of 52 years, as single dose for COVID-19 immunization. Medical history included covid-19 in Sep2020. Concomitant medication was not reported. The patient experienced 24 hours later, after vaccination, her neck started swelling up, her left lymph node; abnormal mass in her neck which was her lymph node, which required hospitalization. The patient she developed a headache over the whole left side of her head. She could hardly move her neck. All of a sudden she kind of broke out in the sweat, left side of her head just went totally numb. Started feeling tingling in her left hand. She went to eat some yoghurt and she could not swallow at all, airway was being compromised by the swelling in her neck. She cannot walk her left leg was dragging, so she was lurking around having to hold on. Her voice was like had to whisper. Right side of her body started shaking, Later that evening the numbness subsided. She could speak better, her left lymph node was still sore. Blood pressure went up, white blood cells count was really, really extremely high. The patient was hospitalized from 14Apr2021 to 16Apr2021. The clinical course was reported by the patient as follows: When probed for the reason of hospitalization, consumer stated, "The symptoms I had was, I got the vaccination in my left arm, 24 hours after getting the COVID vaccination shot on 13Apr2021, almost exactly 24 hours later my neck started swelling up, my left lymph node, which I was expecting to have that problem. And I could hardly move my neck and then I developed a headache over the whole left side of my head and behind my eye and it was hurting and then it hurt my ear. So, I was having ear ache too. So, that went on for about an hour and a half and then all of a sudden I kind of broke out in the sweat and the left side of my head just went totally numb and then I started feeling tingling in my left hand and so I went to the bathroom to see if my face was numb, to see if I had any paralysis of my face which I did not have any at all, it was just numb. So, then I am concerned, so I decide I am going to take an Aspirin and so before I took the Aspirin I wanted to eat something because I had not had anything to eat that day. I went to eat some yoghurt and I could not swallow at all, I couldn't swallow the yoghurt. So, then I am concerned my airway is being compromised by the swelling in my neck. So, I got to call # and then I cannot walk my left leg is dragging, so I am lurking around having to hold on and then when I called # my voice was like had to whisper and it was hard to get an information where I was at. Finally they arrived and I was taken into the ambulance and when I was in the ambulance my blood pressure went up and also the right side of my body started shaking, they took me to the hospital. I was in the hospital. I had MRI, a CT scan and all of those things and it was negative for a blood clot or anything, heart problems or brain bleed. So, they ruled all of that out, my white blood cells count was really, really extremely high that is what the doctor said and anyway so I was admitted in the hospital and now I can talk better and the numbness is going away on the 14th a day later which went on for the symptom. So, later that evening the numbness subsided. I could speak better my left lymph node was still sore and everything and of course they did noticed that in the scan, MRI stuff about the abnormal mass in my neck which was my lymph node.". The patient stated, "I was hospitalized on 14Apr2021 and I was released the evening of 16Apr2021. Treatment: the patient stated they did not treat her for anything except for the high blood pressure when out there and that is it. The clinical outcome of Lymph node pain was not recovered. The clinical outcome of the remaining events was unknown.
52 2021-05-06 peripheral swelling The following morning after receiving the 1st COVID-19 VACCINE (Pfixer) - puffy eyes, tingling and s... Read more
The following morning after receiving the 1st COVID-19 VACCINE (Pfixer) - puffy eyes, tingling and swollen lips, swollen bilateral hands, increased gastritis, low grade fever, headache, body aches. On 4-22-21: Red, slightly raised rash appeared on neck and chest. Still present today (5-7-2021) but only slightly.
52 2021-05-09 swelling My neck and goiter swelled and is still swelled right now. I still have a little neck pain on the ... Read more
My neck and goiter swelled and is still swelled right now. I still have a little neck pain on the left side from the bottom of the shoulder up my neck to my head where the vaccine was done and I am still experiencing extreme fatigue. I had a virtual visit with my doctor about my thyroid and the vaccine and she thought it was the normal side effects of the vaccine but it still continues and it has about 2 weeks. She wants to recheck my thyroid but not until 4 weeks after my second vaccine.
52 2021-05-10 peripheral swelling Her arm was swollen all the way down to her wrist; part under her arm pit was very sore and swollen;... Read more
Her arm was swollen all the way down to her wrist; part under her arm pit was very sore and swollen; extremely painful and relaxing by her side was uncomfortable; extremely painful and relaxing by her side was uncomfortable; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-years-old female patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection; Batch/Lot Number was ER8731; Expiration date: Unknown), via an unspecified route of administration in Arm Right on 14Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant was not reported. On an unspecified date, The patient stated she is calling regarding the Pfizer COVID19 vaccine and has some questions about that. Got the shot about 3 weeks ago and her arm was swollen. The part under her arm pit was very sore and swollen. It did not turn red. She had swelling in her armpit area, for 3-4 days it was very swollen, her arm was swollen all the way down to her wrist and really painful right underneath her arm, The part under her arm pit was very sore and swollen. It did not turn red. Even to put deodorant on was extremely painful and relaxing her arm by her side was uncomfortable. The patient would like to know whether she should get the next dose of the Pfizer COVID vaccine after the side effects she had from the 1st dose. She had called the doctor and they said that it happens sometimes. Does not know if she should get the second shot. Confirmed that the shot was the first dose of the COVID vaccine. Is signed up for the second shot 05May2021. She had COVID and does not want to get it again. Do not want to spread to others. On an unspecified date the patient underwent lab tests and procedures which included antibody test: positive for antibodies, sars-cov-2 test was negative. Had tested negative when she thought she had it and got an antibody test a few weeks later that was positive for antibodies. There is no product complaint to report. Yes, there is a medical information request. No follow-up attempts are needed. No further information is expected.
52 2021-05-12 anaphylactic reaction 4:11 pm tightness and swelling of throat; 4:30 pm anaphylaxis - s/sx swelling of throat and tongue, ... Read more
4:11 pm tightness and swelling of throat; 4:30 pm anaphylaxis - s/sx swelling of throat and tongue, difficulty swallowing, dysphonia, hypertension, low saturation, hoarseness; 4:35pm Tx Epinephrine 0.3 mg IM, ECG, Benadryl 75 mg IV, 5:05pm transport to hospital, ECG, 5:15pm ECG, 5:35 pm famotidine IV, methylprednisolone sodium succinate IV Have had chronic dysphonia since.
52 2021-05-13 swelling Bruise; She had a "goose egg" under her skin that was swollen, hard, painful to touch, red, and hot;... Read more
Bruise; She had a "goose egg" under her skin that was swollen, hard, painful to touch, red, and hot; She had a "goose egg" under her skin that was swollen, hard, painful to touch, red, and hot; She had a "goose egg" under her skin that was swollen, hard, painful to touch, red, and hot; She had a "goose egg" under her skin that was swollen, hard, painful to touch, red, and hot; She had a "goose egg" under her skin that was swollen, hard, painful to touch, red, and hot; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: ER2613; Expiration Date: Jul2021), via an unspecified route of administration, administered in Arm Left on 13Apr2021 14:15 (at the age of 52-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included, she lost 85 pounds in 9 months from an unknown date. The patient received first dose of bnt162b2 on 22Mar2021 in her left arm. Lot: EP6955. It might by SS, there are no dashes. It looks like EP or ER 6955. Expiration date: Jun2021. The patient's concomitant medications were not reported. Caller states that when she gets her second dose, she had it in the same arm that she received her first dose and reports the next evening she had a "goose egg" under her skin that was swollen, hard, painful to touch, red, and hot. Caller states she just assumed this was normal and did not think anything of it. She reports that over the last 3 weeks this has slowly gotten smaller and report it is the "size of an eraser" that she can feel if she presses on her skin. She states that she has also now noticed that there is a bruise and states that she did not initially have any bruising. Caller would like to know if this bruising is normal with the vaccine as she is concerned since it has been so long since she received her second dose. The patient didn't know who else to call. She had her first Covid shot and waited 3 weeks, then she got the second. She got the second one 3 weeks ago today, and she got it in the same arm. With the second shot she noticed by the next day, it didn't hurt to raise her arm and it didn't hurt until she touched it. She had a swollen area on her arm the size of a goose egg. Over the last 3 weeks it has finally shrunk and is now the size of a grain of rice. Now that it has shrunk, a bruise has appeared. She feels fine. She doesn't have Covid. She smokes, that's why she is coughing. She was wondering if this was something serious. It has been 3 weeks and she still has a bruise. Caller declines to provide a physician. She has not been to a doctor in years. She can't tell the last time she went to a doctor. The patient noticed the swelling the next day on 14Apr2021. She can still feel a little knot maybe the size of an end of a pencil. It has slowly gotten smaller over the last 3 weeks. It was the size of a goose egg, bigger than a regular chicken egg. She assumed it was because she had both shots in the same arm. She should have had it in her other arm. It would have been in the evening maybe around 2200 or 2300 at night because she was just about to go to bed. The lights were out in the living room and she came charging out of her bedroom and caught her arm on the door. She thought oh that hurts and put her hand over it and noticed a goose bump. The outcome of the event bruise was not recovered, swelling was recovering, and she had a "goose egg" under her skin that was swollen, hard, painful to touch, red, and hot were unknown. Follow up #1 (04May2021): This is a follow up-spontaneous report received from a contactable consumer reported that the date of vaccination, event and clinical information. No follow-up attempts are needed. No further information is expected. .
52 2021-05-14 lymph node swelling, lymph node pain Pfizer-BioNTech COVID-19 Vaccine EUA Day After - Medium to Heavy Fatigue - Mild Body Aches - Sorene... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Day After - Medium to Heavy Fatigue - Mild Body Aches - Soreness at Injection Point Day 2 - Medium Fatigue - Soreness at Injection Point Day 3 - Light Fatigue - Slight Swelling and Tenderness in Armpit (Lymph Node) of Injection Arm Day 4 - Slight but Easing Swelling and Tenderness in Armpit (Lymph Node) of Injection Arm
52 2021-05-14 peripheral swelling throat felt swollen ,and soar my lungs felt raw like when you have bad congestion; throat felt swoll... Read more
throat felt swollen ,and soar my lungs felt raw like when you have bad congestion; throat felt swollen; Arm swollen muscles very painful through neck into jaw down my left side into my leg ,down to ankle, jaw felt numb at times; Arm swollen muscles very painful through neck into jaw down my left side into my leg ,down to ankle; shoulder pain; nausea; chills; Jaw felt numb at times; extremely tired; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 23Apr2021 10:45 AM at the age of 52-years-old (Batch/Lot Number: ER8735) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included cardiomyopathy from an unknown date. The patient did not have known allergies. Concomitant medications included metoprolol and lisinopril, taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021 02:00 PM, the patient experienced arm swollen, muscles very painful through neck into jaw down my left side into my leg ,down to ankle, jaw felt numb at times ,shoulder pain went on for 7 days ,nausea ,chills ,extremely tired ,her throat felt swollen ,and soar her lungs felt raw like when you have bad congestion ,hard to function tired all week. The patient did not want to take 2nd dose too many side effects. Therapeutic measures were taken included Tylenol, Asprin, loratadine famotidine tums. The outcome of the events was resolving.
52 2021-05-16 peripheral swelling A small swollen lump under Left arm, sleepiness, fatigue
52 2021-05-16 swelling Six days after second injection my toes turned purple/red and swollen. The skin peeled off and I hav... Read more
Six days after second injection my toes turned purple/red and swollen. The skin peeled off and I have had numbness and pain since. Three weeks on, they are still painful and red
52 2021-05-17 lymph node swelling extreme fatigue for 4 days. minor constant headache daily since and still. Elevated Hear rate for 1... Read more
extreme fatigue for 4 days. minor constant headache daily since and still. Elevated Hear rate for 10 days after 1st shot and again after 2nd ( I wear an apple watch so I can keep track) Extreme anxiety, feeling of passing out. blackness coming from behind me. need to put my head down on my desk almost daily for 10 after 1st shot and still now sporadically. Smelling cigarette smoke when there is none around. Swollen lymph nodes in armpits, neck groin.
52 2021-05-18 lymph node swelling pt says next day after taking the vax she started having a burning joint pain in her left shoulder a... Read more
pt says next day after taking the vax she started having a burning joint pain in her left shoulder and the arm pit lymph node is swollen. The joint pain went across to the other shoulder joint. The pain went from her right shoulder down to her elbow, to her wrist down to her hip, knee and ankle. The pain moved to all of the joints on the right side of her body. Her blood pressure was going up. It went from 110/70 to 149/89. She gets a severe pain on the right side of her head like a headache. She has a constant ringing in her head. She has short term memory loss and expressive aphasia. She went to OB/GYN on 3/3/21. He sent her to see her PCP NP on 3/7/21. She was given a Medrol dose pack and antibiotics. Pt had lab work. She wasn't getting better so went back about a week later and saw Dr. She was prescribed 40 mg of prednisone. She was referred to Neurologist. He ordered her an MRI and EEG. The MRI showed 3 spots on it which doctor want overly concerned about but the EEG was abnormal so she was rescheduled for further testing on 9/28/21.
52 2021-05-18 peripheral swelling frontal headache for 3 days, left arm pain for 3 days and swelling, general fatigue for 1 week, redn... Read more
frontal headache for 3 days, left arm pain for 3 days and swelling, general fatigue for 1 week, redness on the tongue, middle anterior part as if it were burned, and the middle distal part a whitish plaque for two days as if I had oral candidosis, Then it started at 300 am I felt something so intense that I woke up, as if the brain were tipping me inside my head and vertigo began, everything turned me when I opened my eyes, as if I had drunk a lot of alcohol and everything gave around me when I opened my eyes, it was lake so strong that I felt that I was falling from my bed,I had to go to my primary doctor because when I changed the position of my head and lowered it, the severe vertigo began and I had to hold on to avoid falling.Then I decided to get the second dose to complete my vaccination despite these adverse effects, the doctor indicated drugs for vertigo and examined me, and now 2 weeks ago that after having a year without menstruation, I was already in menopause, I I have profuse bleeding with clots and I have been bleeding for 15 days.
52 2021-05-18 peripheral swelling Allergic reaction: swelling from her elbow to fingertips on left side, swollen eyes, coughing, swo... Read more
Allergic reaction: swelling from her elbow to fingertips on left side, swollen eyes, coughing, swollen tongue, elevated BP, sweating, tired Patient received benadryl 50mg, pepcid 20mg prior to vaccine due to history of allergies. Patient was sent by ambulance to the ER.
52 2021-05-19 anaphylactic reaction Anaphylaxis - started ten minutes after the vaccine. Ended up in an ambulance and to the emergency ... Read more
Anaphylaxis - started ten minutes after the vaccine. Ended up in an ambulance and to the emergency room. Was given benadryl and steroids through IV and was home about five hours later.
52 2021-05-19 lymph node swelling, neck mass Swollen glands in neck and loss of voice, weak, lightheaded, vomiting, chills, body aches, extreme t... Read more
Swollen glands in neck and loss of voice, weak, lightheaded, vomiting, chills, body aches, extreme thirst, constant sleep, heart rate high within 48 hours. At 48 hours, severe breathing issues and small sores on upper arms and chest. Now on day 5, shortness of breath continues, spells of sweating, no sleep for 2 days, and a fluid filled Knoton lower front neck. Had to miss a day and a half of work so far this week
52 2021-05-19 lymph node swelling Severe swollen lymph nodes on my whole left side, and multiple lumps scattered on my legs After 3 m... Read more
Severe swollen lymph nodes on my whole left side, and multiple lumps scattered on my legs After 3 month lymph nodes are still present, my Lymphocites count is very high and I have severe fatigue and generalized body/muscle ache and malaise, with recurrent episodes of fever that last a few hours and goes away
52 2021-05-20 lymph node swelling Swelling and pain in left armpit. Not treated as of today.
52 2021-05-20 swelling Within approximately 15 minutes appreciating the vaccination I began to feel light-headed and nauseo... Read more
Within approximately 15 minutes appreciating the vaccination I began to feel light-headed and nauseous. That sensation continued 4 the next week and finished approximately Friday, May 14th. An approximately May 11th, I started experiencing sporadic, cough, runny nose, sore throat, chills, headache, dull pain in eyes and sharp joint pain. Additionally I felt as if I had a fever but I had been taking Tylenol two to three times a day. Most of these symptoms drafted from approximately the 11th through 14th. I had a chest x-ray on the 13th with negative results. I have covid rapid test shortly before and again on the 14th both with negative results. I also noticed swelling at the base of my neck I'm around May 11th which has persisted to date. I am assuming this is due to swollen lymph nodes although such has not been confirmed by health professional. I reported my symptoms at the vaccination site. The nurse was prepared to use my EpiPen but such was not needed. I left the site after waiting about 45 minutes even though my nausea and lightheadedness remained. Presently I still have headaches throughout the day, sore throat and a hoarse voice.
52 2021-05-22 lymph node swelling Redness, rash under chin, swollen white spots by lymph nodes under chin, some neck rash Took Benadr... Read more
Redness, rash under chin, swollen white spots by lymph nodes under chin, some neck rash Took Benadryl and went away
52 2021-05-23 peripheral swelling PATIENT EXPERIENCED SWELLING IN ARM ABOUT 5 MINUTES AFTER VACCINATION.
52 2021-05-25 lymph node swelling April 5th 10-15 minutes after dose: tight throat and chest, congested, feeling out of it within 10-... Read more
April 5th 10-15 minutes after dose: tight throat and chest, congested, feeling out of it within 10-15 minutes after dose Later that day: tachycardia, burning sensation throughout body, tingling in nasal passage, arms and legs, lower back pain, lightheaded, joint pain, chills April 6th additional symptoms to above and ongoing at various degrees: migrating shock sensation, cold extremities, swollen lymph nodes, shaking, ear ringing, fatigue, muscle cramping and stiffness, unsteady while sitting and standing, back weakness, periodic cough, nausea
52 2021-05-26 lymph node swelling swollen lymph nodes in right armpit appeared after about 24 hours from vaccination, the bulge grew t... Read more
swollen lymph nodes in right armpit appeared after about 24 hours from vaccination, the bulge grew the size of chicken egg over th e next 2 days+ fullness/swollen ear canals, both ears. arm pit nodes returned to almost normal condition after 5 days from onset of symptoms, some discomfort remains under armpit but transient (sometime tender nodes are present and other times not). swollen ears remains a problem 2.5 weeks later, partial hearing loss due to swelling. no medical treatments
52 2021-05-27 peripheral swelling Immediate dizzyness followed by headache. Next day slight fever, fatigue, flare up of arthritis, sw... Read more
Immediate dizzyness followed by headache. Next day slight fever, fatigue, flare up of arthritis, swelling in ankles and by 3rd or 4th day, diarreha. 2nd dose had consult with on site doctor about my lingering symptoms. Doctor asked me a few questions. I already had Covid-19 back in January 14th, 2021. Doctor determined i should be fine. It got worse. I honestly felt like i had Covid-19 all over again, only worse beccause I was vomiting the next morninng. I had all the same exact symptoms that I had originally in January, only worse, besides vometing, arthritis flare up, feel like I have carpal tunnel syndrom, couldn't do anything with my right hand for 2 days, and the swelling of ankles/feet and hands. Do not let me forget about the fatigue and shortness of breath. I feel like i have been hit by a truck. I even had the fever for 1 day. It was only around 99, however, I naturally run at 97.7, so 99 is high for me. Personally, I feel like I received the vaccine too soon after actually having Covid-19. I am just praying that this arthritis and carpal tunnel symptoms go away. Oh and the random shooting pains all through out my body. I am still having that as well and it has been 8 days since my 2nd dose.
52 2021-05-30 swelling face 4 hours later, facial swelling, itching, redness, terrible headache. Headache lasted 4 days. For nex... Read more
4 hours later, facial swelling, itching, redness, terrible headache. Headache lasted 4 days. For next dose, pre-treated with Tylenol and Benadryl and she tolerated it.
52 2021-05-31 axillary mass Pain up and down back, arm at time of injection. Lasted rest of day. Next day arm still hurt and the... Read more
Pain up and down back, arm at time of injection. Lasted rest of day. Next day arm still hurt and then concentrated in arm pit, was sore to the touch and had a lump for a week.
52 2021-05-31 lymph node swelling, lymph node pain Shot was Friday 28May21 12:50 pm. I awoke Saturday with a sore arm, armpit and left ribcage into bre... Read more
Shot was Friday 28May21 12:50 pm. I awoke Saturday with a sore arm, armpit and left ribcage into breast. By night fall, it became Inflamed lymph nodes in armpit with slight swelling in left breast. This lasted throught Monday night. I also had a tender right armpit on Monday. A severe ocipital headache accompined this. I did a hot soak in the bath with epsom salt on Sunday. I took ibuprofen and excederine migrane for the headache and inflamation, along with hot and cold compresses, primaraly hot. Inflamaiton is almost gone, but still tender today, Tuesday 01Jun21. I notified my Doctor today. Side note, it is possible that I had an undiagnosed case of Covid-19 last February-March 2020.
52 2021-05-31 lymph node swelling under arm started to burn, went and looked and glands had swollen up to golf ball size; under arm st... Read more
under arm started to burn, went and looked and glands had swollen up to golf ball size; under arm started to burn; Pain in joints; headache on right side; This is a spontaneous report from a contactable other health care professional (patient). A 52-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration administered in right arm on 02Feb2021 11:00 as a single dose for covid-19 immunization. Medical history included asthma, gluten allergy, fructose allergy, lactose allergy. Concomitant medications included calcium, tea, green, diindolylmethane (DIM), Asthma inhaler and Vit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient has not been tested for COVID-19. The patient previously took historical vaccine of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unknown date as a single dose for covid-19 immunization. On 03Feb2021, the patient experienced pain in joints and headache on right side. In the evening at about 5:30, under arm started to burn, and glands had swollen up to golf ball size. No treatment was received for the adverse events. Seriousness of the events was assessed as non-serious by reporter. The outcome of the events was resolving. Follow-up attempts have been completed and no further information is expected. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
52 2021-06-01 lymph node swelling Injection site pain; Tierdness; joint pain; Headache; Chills; Swollen lymph node; Feeling unwell; Th... Read more
Injection site pain; Tierdness; joint pain; Headache; Chills; Swollen lymph node; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6208), via an unspecified route of administration in the left arm on 12Mar2021 at 16:30 (at the age of 52-year-old), at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included chronic knee pain. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Meloxicam, Rosuvastatin, empagliflozin (JARDIANCE), Valsartan, Fenofibrate, Amlodipine, Paroxetine and Hydrocodone (reported as hydrocidine). On 13Mar2021, the patient experienced favor chills, headache, joint pain, tiredness, swollen lymph nodes, feeling unwell, injection site pain/soreness. Events were resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovering. The report was reported as non-serious. No follow-up attempts are needed. No further information is expected.
52 2021-06-03 lymph node swelling Soreness at site of injections; muscle aches; swollen lymph node; sore throat; This is a spontaneous... Read more
Soreness at site of injections; muscle aches; swollen lymph node; sore throat; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was not reported) via an unspecified route of administration on 05Mar2021 at 14:45 (at the age of 52-years-old) in the left arm as second dose, single for covid-19 immunization. The patient medical history included asthma and had known allergies with PEN. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route on 14Feb2021 at 15:30 as 1st dose, single dose for COVID-19 immunization. The patient concomitant medications included lifitegrast (XIIDRA) and cannabidiol (CBD OIL). On 05Mar2021 at 22:00, the patient experienced soreness at site of injections, muscle aches, swollen lymph node and sore throat. The patient did not received treatment for events. The outcome of the events was not resolved. No follow up attempts are possible. Information about lot/batch number cannot been obtained.
52 2021-06-03 oral herpes About 2 weeks after second shot have had cold sores; This is a spontaneous report from a non-contact... Read more
About 2 weeks after second shot have had cold sores; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: Unknown) via an unspecified route of administration in the left arm on 13Feb2021 (at the age of 52 years old), as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: Unknown) via an unspecified route of administration in the left arm on 16Jan2021 at 10:30, as a single dose for COVID-19 immunisation. The patient medical history included asthma from unknown date. The patient did not received any other medications within 2 weeks of vaccination. The patient has allergies to medications, food, or other products and Sulfa was reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. About 2 weeks after second shot, The patient experienced cold sores one after the other so far four on 27Feb2021. Therapeutic measures were taken as a result of cold sores and included treatment with oral Famvir. The clinical outcome of the cold sores was recovering. Information about lot/batch number cannot be obtained. No further information expected.
52 2021-06-03 peripheral swelling I felt dizzy; arm for itchy; now it's all red; now it's all hot; now it's all swollen.; This is a s... Read more
I felt dizzy; arm for itchy; now it's all red; now it's all hot; now it's all swollen.; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number= Unknown) via an unspecified route of administration on 17Feb2021 at 18:00 in left arm as single dose for COVID-19 immunization. Patient had no known allergies. Patient had no other medical history. Other medications (concomitant) in two weeks included estrogen and progesterone. Patient did not receive any other vaccine within four weeks of suspect vaccine. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. On 06Mar2021 at 12:00 PM, 16 days and 18 hours after first dose of vaccine, patient felt dizzy, arm for itchy and now it's all red, hot and swollen. Patient did not receive any treatment for the events. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
52 2021-06-07 peripheral swelling Blurred vision; Thyroid inflamed; tingling all through out the whole body; blue hands/Black and blue... Read more
Blurred vision; Thyroid inflamed; tingling all through out the whole body; blue hands/Black and blue mark swollen on calfs; Pain in right leg; Black and blue mark swollen on calfs; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on an unspecified date (at the age of 52-years-old) (Batch/Lot Number: 648543) as single dose for covid-19 immunisation. Medical history included hashimotos. Concomitant medications included ergocalciferol (VITAMIN D); cyanocobalamin (VITAMIN B12) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was no pregnancy. The patient was no pregnancy at time of vaccination. Age at vaccination was 52 years. The patient experienced blurred vision, thyroid inflamed, tingling all through out the whole body, blue hands, pain in right leg and black and blue mark swollen on calfs on 15Apr2021. The events resulted in emergency room/department or urgent care. The patient was hospitalized for the events for 1 day. The report was serious with the seriousness criteria of hospitalization. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
52 2021-06-07 swelling face itchiness body wide; headache; tingling in mouth and face; tingling in mouth and face; swollen face;... Read more
itchiness body wide; headache; tingling in mouth and face; tingling in mouth and face; swollen face; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 09Mar2021 13:00 (Lot Number: EN6207) (at the age of 52-years-old) as 1st Dose, single dose for covid-19 immunization. Medical history included PFO/ASD (Atrial Septic Defect) , TIA (transient ischaemic attack), asthma, high BP (blood pressure), diabetic and obesity. Patient has known allergies in cinnamon, cloves, allspice, adhesives, mold and pollens. The patient was not pregnant and did not have COVID prior to vaccination. Concomitant medications included BP medication, zolpidem and cholesterol medication. The patient did not receive other vaccine in four weeks. The patient experienced itchiness body wide, headache, tingling in mouth and face and swollen face even after taking 2 BENADRYL on 09Mar2021 at 13:15. The patient was not tested for COVID post vaccination. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
52 2021-06-07 swelling whole body rash/an allergic reaction; still somewhat itchy at times; whole body rash/rash all over b... Read more
whole body rash/an allergic reaction; still somewhat itchy at times; whole body rash/rash all over body/rash is on both arms, her back , on the thighs of both legs, behind and the sides of both knee caps, and on her right ankle; rash as being red, swollen, rough in texture like it's prickly, like heat little bumps; rash as being red, swollen, rough in texture like it's prickly, like heat little bumps; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration, administered in left arm at age 52years on 22Jan2021 as single dose for covid-19 immunisation. Medical history included psoriatic arthritis, immune deficiency and heart attack these were at the age of 30, total 4 back surgery, high blood pressure (under control), high cholesterol (under control), birth control and heart disease (sister and mom had heart disease). Concomitant medications included hydrochlorothiazide, irbesartan (IRBESARTAN HCTZ) at 150-12.5mg once a day, atorvastatin (LIPITOR) at 20 mg, metoprolol 50 mg once a day, norethisterone (NORA BE) for birth control, apremilast (OTEZLA) at 40 mg twice a day, aminobenzoic acid, biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, lecithin, medicago sativa herb, nasturtium officinale leaf, nicotinamide, oryza sativa, petroselinum crispum leaf, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (SUPER B COMPLEX), fish oil at 1000 mg, vitamin c (ascorbic acid) at 1000 mg, vitamin d nos at 5000 iU dose, coenzyme q10 (ubidecarenone) once daily, omeprazole (PRILOSEC) at 20mg once a day, curcuma longa root (TURMERIC CURCUMIN) at 500 mg twice a day, alpha lipoic acid twice a day and fluorometholone (1 drop both eyes) once a day for all the drugs start and stop dates were not reported. Patient got first shot on 22Jan2021 after lunch at noon and since then has had a rash all over body. She has been taking Benadryl. Even the nurse who administered the vaccine at the time gave 2 Benadryl's. She was also taking Allegra 24 hours daily. She was due to get the second shot this Friday and wants to know if that was still okay. She has been taking Allegra since it happened. She only takes the Benadryl at night because it makes her tired. Caller stated that she has concerns about getting second dose or not. Patient second shot was scheduled on 12Feb2021. Patient clarified that on 22Jan2021 after the vaccine the rash started in 3-5 minutes after receiving the vaccine, the rash was on both arms, her back, on the thighs of both legs, behind and the sides of both kneecaps, and on her right ankle. She described the rash as being red, swollen, rough in texture like it's prickly, like heat little bumps, when she was rubs her hands on arm, she can feel the bumps. The rash was getting better but still somewhat itchy at times. It has been 2 weeks. She was wanting to know if she was still to get the second shot on Friday. Patient did not have Covid Vaccine product details to provide since she has left her Covid CDC card at home. The outcome of the event rash all over was recovering and unknown for other events. Information about Batch/Lot number has been requested. Follow-up (07MAY2021): Follow-up attempts are completed. No further information is expected
52 2021-06-09 lymph node swelling, swelling face arm is sore at injection area. More concerning I woke up before 5 AM heart was pounding and the left... Read more
arm is sore at injection area. More concerning I woke up before 5 AM heart was pounding and the left side of my face was swollen and my left I was hooded and almost shut, all subsided around 11 AM My lymph nodes in my left arm pit and outside of breast and inside rib cage started tingling swelling about an hour after shot , and left forearms feel tight today. Today is day 2 and left and right lymphnodes are sore in arm pits and joint pain in ankles and elbows,
52 2021-06-10 lymph node inflammation Serious arm pain that radiated to hand and across my back with inflamed lymph nodes on left side of ... Read more
Serious arm pain that radiated to hand and across my back with inflamed lymph nodes on left side of my body. Inflammation of lymph nodes lasted for 2 weeks arm pain continues almost 3 months later.
52 2021-06-10 lymph node swelling swollen Lymph nodes in left neck/clavicle area; This is a spontaneous report from a contactable phar... Read more
swollen Lymph nodes in left neck/clavicle area; This is a spontaneous report from a contactable pharmacist. A 52-year-old (non-pregnant) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via intramuscular route of administration in the right arm on 01Feb2021 (at the age of 52-year-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Medical history included breast cancer (CA) female "13 years post breast CA, chemotherapy and mastectomy". The patient's concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. on 01May2021, the patient developed swollen lymph nodes in left neck/clavicle area. CT scan done (unspecified date in May2021 with unknown results). When visited oncologist for evaluation (unspecified date in May2021), node was negative but the oncologist noted they were seeing this in post -CA patients. He acknowledged it was a bit farther out than usual, the vaccine was a possible reason. The clinical outcome of the swollen lymph nodes in left neck/clavicle area was resolving. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event "swollen Lymph nodes in left neck/clavicle area" cannot be completely excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-06-10 peripheral swelling Feet started to hurt, she couldn't put weight on her feet and they were turning black; Legs and feet... Read more
Feet started to hurt, she couldn't put weight on her feet and they were turning black; Legs and feet were hurting so bad; Legs and feet were hurting so bad; She couldn't put weight on her feet and they were turning black; She couldn't put weight on her feet and they were turning black; Legs and feet were starting to swell; Legs and feet were starting to swell; Her hands were black; Hands were starting to swell up; This is a spontaneous report from a contactable consumer (the patient). A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 at 17:00 (Lot Number: EW0151), at the age of 52 years, as a single dose for COVID-19 immunisation. Medical history included crohn's disease (Crohn's disease Diagnosed at age 25), thyroid disorder (thyroid Diagnosed in her 30's). Concomitant medication taken within two weeks of vaccination included vitamin b12, zinc, potassium, tocopheryl acetate (E-VITAMIN), cyanocobalamin (B12), and vitamin b complex (VITAMIN B), all taken for crohn's disease; levothyroxine taken for thyroid disorder, dicycloverine (DICYCLOMINE) taken for abdominal pain, and omeprazole (PRILOSEC). The patient experienced feet started to hurt, she couldn't put weight on her feet and they were turning black on 10Apr2021, hands were starting to swell up on 07Apr2021, her hands were black on 08Apr2021, legs and feet were starting to swell on 09Apr2021, legs and feet were hurting so bad on 10Apr2021. She couldn't put weight on her feet and they were turning black on 10Apr2021. The patient was hospitalized for feet started to hurt, she couldn't put weight on her feet and they were turning black on 10Apr2021. The patient received treatment. The verbatim clinical course was reporter as follows: The patient is calling about the Pfizer covid vaccine. The patient had the first dose on 07Apr2021. By 10Apr2021 the patient was in the hospital, they thought at first the patient had blood clots. The patient is still not back to work yet. They keep having the patient have tests done. The patients hands and feet turned black and were swollen up after she received the vaccine. The patient got the vaccine at 5:00pm on 07Apr2021, and that night her hands were starting to swell up. The patient thought it was because of her Crohns. Then the vessels in the patients fingers started busting, is what it looked like, and her hands were black and she couldn't hardly move them on 08Apr2021. Then the next day, 09Apr2021, the patient noticed her legs and feet were starting to swell. The next day, 10Apr2021, the patient was starting to look down and her legs and feet were hurting so bad she had to sit down when she was vacuuming. The patient thought she stepped on the vacuum cord when her feet started to hurt, she couldn't put weight on her feet and they were turning black. The patient propped her legs up and then soaked them in Epson salt and hot water and that made them worse. The patient went to healthcare facility on10Apr2021 and they said it looks like she has blood clots so they sent her to emergency room. In the emergency room they admitted the patient and did test after test. They gave the patient morphine for the pain that was shooting down her legs, it felt like needles were sticking in her legs. The patient was out of it for a couple of days because when she got that morphine she didn't know she was in the world. Morphine- unknown lot, NDC , and expiration dates for doses involved. They gave the patient gabapentin and that helped some. They were giving the patient so much Gabapentin during the day she couldn't function so they cut it back to giving it to at night. The patient was taking the Gabapentin 3 times a day, at the time, and she couldn't function on it. Gabapentin- unknown lot, NDC, and expiration date for the doses given in the hospital. The night of 07Apr2021 the patient couldn't really move her fingers and took it easy. 09Apr2021 is when this started in her feet. Then on 10Apr2021 the patient went to the hospital because the pain was so bad. By the end of the day the patient is still swollen. One leg was swollen more than the other but they are not black and blue like they were and they said its from nerve damage. The patient was so drugged up in the hospital, she didn't know her name. The patient has an EMG test scheduled on 04Jun2021. The patient was scheduled for the second shot on 28Apr2021 and didn't get it because she was told not to by her doctor and the hospital doctors. Test in the hospital was as follows: 10Apr2021: US venous leg bilateral, chest x-ray with one vw portable, CBC with differential, CMP, d-dimer, EFR, INR, active particle thromboplastin time, EKG. On 11Apr2021: TSH, TR3, CK, Magnesium, sars-cov-2antigenfia with reflux to covid rapid test- negative, aorta angiogram runoff with contrast, x-ray of the foot lateral and oblique. On 12Apr2021: Magnesium, CBC, BMP, ANA, ANA titer. On 13Apr2021: CBC,BMP, and a urinalysis with reflex. On 19May2021: MRI lumbar and spine with and without contrast was ordered by the neurologist. The patient reported that she thought that the hospital reported this so she went back to her paperwork and called today to report this event. The clinical outcome of She couldn't put weight on her feet and they were turning black, Legs and feet were hurting so bad, and Legs and feet were starting to swell was unknown. The patient was recovering from the remaining events. Additional information has been requested.
52 2021-06-13 swelling I have been having arm stiffness and pain in the injection site and some swelling in my arm pit
52 2021-06-13 swelling Red circle with hard bump and itchy, about 2inches in diameter
52 2021-06-15 lymph node pain, lymph node swelling Tiredness; headache; muscle pain; nausea; overall unwell feeling; lymph nodes under my right arm whe... Read more
Tiredness; headache; muscle pain; nausea; overall unwell feeling; lymph nodes under my right arm where injection was given, swelled to the size of a baseball, and was tender and uncomfortable; lymph nodes under my right arm where injection was given, swelled to the size of a baseball, and was tender and uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient (not pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number ENG202), via an unspecified route of administration, in Right Arm on 10Mar2021 at 09:45 AM(at 52 years) as single dose for covid-19 immunisation. Medical history included possibly allergy to sulphuric a long time ago. Concomitant medications were not reported. On 10Mar2021 at 08:45 PM, the patient experienced tiredness, headache, muscle pain, nausea, overall unwell feeling; her lymph nodes under right arm (where injection was given) swelled to the size of a baseball and was tender and uncomfortable. No treatment given. The final outcome of the events was not recovered.No follow-up attempts are possible. No further information is expected.
52 2021-06-15 swelling face Pt presented to pharmacy for a covid shot and received a dose of pfizer on 6/12/21. Later in the day... Read more
Pt presented to pharmacy for a covid shot and received a dose of pfizer on 6/12/21. Later in the day the pharmacist that administered shot realized that the patient had received a dose of moderna on 5/11/21. She called the patient to discuss the situation and to let us know of any potential side effects. Tonight 6/16/21 the patient calls the pharmacy and i discuss the situation with her. She said she started having severe body/bone/muscle aches on the afternoon of the pfizer shot which was 6/12. She said she knew that was somewhat normal but on 6/13 the body aches were worse and she started having swelling in her face and couldn't get her legs to work walking up two stairs without assistance. She started taking benadryl "around the clock". On 6/14 she said her symptoms were mostly unchanged, still having swelling in face and legs/arms hurting. On 6/15 she "blacked out" meaning she was sleeping and woke up and when she went to stand up her legs collapsed and she slid off the bed but she said she didn't hit her head. She said that happened two different times on 6/15. Today, 6/16 she called the pharmacy because her lips were the most swollen and sore they have been and it hurt to drink cold water and was hard to talk. She said she had to use her inhaler that morning because her chest was a little tight but she wasnt having any trouble breathing and her throat was fine. She said her face was still swollen and she looked like she'd been punched in the mouth. I counseled her to seek medical help asap since she was having trouble walking and the falling down and the face swelling hadn't gone away and she said she didn't want to go to the ER but would call her dr on the am of 6/17/21. I told her if anything changed she needed to go to ER or call 911. No other info at this time. 8:40 pm 6/16/21
52 2021-06-16 lymph node swelling Very painful ejection itself followed by immediate soreness and swelling. Severe soreness and swell... Read more
Very painful ejection itself followed by immediate soreness and swelling. Severe soreness and swelling over a couple of weeks. Once it started to abate I am left with significant immobility in the shoulder. I am unable to sleep on my left side, have weakness in my left arm, and numbness in my left arm and hand. This persists 3 months after the initial injection.
52 2021-06-17 anaphylactic reaction Anaphylactic reaction requiring IM epinephrine following dose #2 of Pfizer vaccine. Patient experie... Read more
Anaphylactic reaction requiring IM epinephrine following dose #2 of Pfizer vaccine. Patient experienced nausea ~30 minutes after administration and went on to experience throat tightness and SOB. During this reaction, the patient reported she had an anaphylactic reaction to an influenza vaccine in the past with an onset of ~2 hours s/p administration. This was not in her chart nor reported on intake. Epi-Pen 0.3 mg was administered and a Code Blue was called. Code team transported the patient to the ED.
52 2021-06-17 swollen extremities Headache, body aches, muscle aches, fever, fatigue, starting 24 hour after injection of the mRNA and... Read more
Headache, body aches, muscle aches, fever, fatigue, starting 24 hour after injection of the mRNA and lasting 2-3 days. Diarrhea on day 3. However, the headache, fatigue and muscle aches lasted 6-7 days. At that point, she began to develop pitting edema in both ankles and legs, this was worst on day 8-9 and is slightly improved, but still noticeable 2 weeks later. Also, left arm soreness for 3 days at the site.
52 2021-06-18 swelling Rash, Flushing Red skin upper abdomen, headache, fatigue, swelling in neck, pain in arm, cramps in c... Read more
Rash, Flushing Red skin upper abdomen, headache, fatigue, swelling in neck, pain in arm, cramps in calves, dizziness, vertigo. Symptoms began on June 15th, 2021 shortly after 2nd dose of Covid 19 Pfizer vaccine and continue until time of reporting June 19th, 2021. Rash and redness and leg cramps, swelling and arm pain lasted 24-72 hours. Others symptoms including headache and vertigo and fatigue continue to date of this reporting.
52 2021-06-20 peripheral swelling I experienced redness and swelling under my left armpit, discoloring as well.
52 2021-06-21 peripheral swelling, lymph node swelling Tightness in chest, heaviness in chest, SOB when lying down, pains in chest sitting or standing or l... Read more
Tightness in chest, heaviness in chest, SOB when lying down, pains in chest sitting or standing or lying down, aches in center of chest, heart fluttering, pain in center right side of chest by heart. Headache, blurry vision, pressure in chest when bending over, swelling on left leg, lymph nodes swollen pain under arms. Left arm sore, rash off and on with redness.
52 2021-06-22 lymph node swelling I started getting the arm lymph nodes being swollen right above my breasts and I was really scared. ... Read more
I started getting the arm lymph nodes being swollen right above my breasts and I was really scared. I am still tired from the vaccination. I saw the Dr. and they told me to place cold/hot compresses in my breasts. The swelling and pain is gone. The terrible nausea and diarrhea that I experienced had gone away after the day of the vaccination.
52 2021-06-22 swollen extremities Fever, headache, body aches, nausea, diarrhea, lymphedema of left leg and left face lasting three da... Read more
Fever, headache, body aches, nausea, diarrhea, lymphedema of left leg and left face lasting three days; plus severe fatigue lasting six weeks.
52 2021-06-23 swollen extremities Multiple blood clots (DVTs) to BLLE with gross edema, decreased mobility, stasis ulcers, kidney ston... Read more
Multiple blood clots (DVTs) to BLLE with gross edema, decreased mobility, stasis ulcers, kidney stones and ?fluid on kidneys? (NOS), hematuria, wound clinic treatments required, loss of ability to work, increased depression and stress r/t above.
52 2021-06-24 swelling face I have side effects where my face has been swollen, may be one to two weeks after that; its feel swo... Read more
I have side effects where my face has been swollen, may be one to two weeks after that; its feel swollen and it's not going down yet; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was unknown (reported as that EW69, she doesn't know it J or 35), and Expiration Date was not reported), via intramuscularly, administered in Arm Right on 04Apr2021 (at the age of 52-year-old) as a single for COVID-19 immunization. Medical history included dialysis and blood pressure high from an unknown date and unknown if ongoing. Concomitant medications included minoxidil, carvedilol, amlodipine, valsartan for Hypertension and ascorbic acid, biotin, cyanocobalamin, folic acid, nicotinamide, pantothenic acid, pyridoxine, riboflavin, thiamine, zinc (RENAPLEX) taken dialysis, start and stop date were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW7534, Expiration Date: Unknown), via intramuscularly, administered in Arm Right on 12Mar2021 as a single dose for COVID-19 immunization. On 04Apr2021, after the second shot, patient had side effects where her face has been swollen, may be one to two weeks after that and its feel swollen and it's not went down yet. Patient stated that no one had told her what was happening. Patient did not receive any treatment for adverse event. The patient underwent lab tests and procedures which included tyrosine Serum, magnesium Serum, Micro HLB, CBC Differential Platelets, Hemoglobin A13, Hepatitis B antibody, Hepatitis C, Micro Keratin Ratio and Metabolic Panel with unknown results on an unspecified date. The outcome of event was not recovered. Additional information has been requested.
52 2021-06-24 swelling Upset stomach; upset stomach and swollen and itchy; Body ache; Itchy rash; fever of 102.4 F; Extreme... Read more
Upset stomach; upset stomach and swollen and itchy; Body ache; Itchy rash; fever of 102.4 F; Extremely bad headache; This is a spontaneous report received from a contactable patient. A 52-year-old adult non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on 16Mar2021 at 13:15 (at the age of 52 years) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 16:00, the patient experienced rash, fever of 102.4 F, upset stomach and swollen and itchy, extremely bad headache and body ache. The patient underwent lab tests and procedures, which included body temperature measurement on 16Mar2021 at 16:00 and result was 102.4 F. No therapeutic measures were taken in response to the events. The clinical outcome of events itchy rash, fever, upset stomach, swelling extremely bad headache and body ache was recovered with sequalae. No follow-up attempts are possible; information about lot/batch number cannot be obtained
52 2021-06-28 lymph node swelling Severe fatigue started the following day, followed by severe axillary adenopathy on the left side (t... Read more
Severe fatigue started the following day, followed by severe axillary adenopathy on the left side (the side of the vaccine), then severe muscle spasm and radicular pain on the left arm, shoulder and neck
52 2021-06-29 lymph node swelling I had swollen lymph nodes and I received the symptoms when I had my mammogram.
52 2021-06-29 peripheral swelling I went to see my doctor because of swelling and pain on both ankles, feet, and legs. The doctor said... Read more
I went to see my doctor because of swelling and pain on both ankles, feet, and legs. The doctor said I have edema. The pain and swelling is still ongoing on my ankles, feet and legs.
52 2021-06-30 anaphylactic reaction had prior anaphylactic reaction, seen at ED; This is a spontaneous report from a contactable physici... Read more
had prior anaphylactic reaction, seen at ED; This is a spontaneous report from a contactable physician (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 17Jun2021 12:00 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Patient age at vaccination was 52-year-old. The patient medical history included sulfa allergy. Patient was not pregnant. Historical vaccine included 1st dose of BNT162B2 on 27May2021 at 12:00 pm via intramuscular in left arm for COVID-19 Immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID), duloxetine and fexofenadine hydrochloride (ALLEGRA), all taken for an unspecified indication, start and stop date were not reported. The patient had prior anaphylactic reaction on 17Jun2021. Event resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (Immediate risk of death from Event). Therapeutic measures were taken as a result of event included epi x 2, steroids, Benadryl. Outcome of the event was not resolved. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-06-30 peripheral swelling the bone marrow almost hurts; The caller can't move her left arm; Weak and tired; Weak and tired; he... Read more
the bone marrow almost hurts; The caller can't move her left arm; Weak and tired; Weak and tired; her left arm, it got swollen, very red and very painful; her left arm, it got swollen, very red and very painful; her left arm, it got swollen, very red and very painful; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0217) via an unspecified route of administration, administered in Arm Left on 17Jun2021 15:20 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen (ADVIL 12 HOUR,lot number OME2586A, expiry date Oct 2022) taken for an unspecified indication, start and stop date were not reported. The patient reported that her left arm got swollen, very red, and very painful after the first dose of the Pfizer BioNTech covid 19 vaccine yesterday,17Jun2021. The patient second dose is scheduled for 08Jul2021. She took Advil at 3:00 am and iced her arm and then the pain proceeded to run down her arm into her shoulder blade, the left side of her neck, and down into her left hand. The patient feels like she was kicked 4 times by a donkey or punched in the arm. It is like the patient has a Pop Eye Arm. There is a red spot where she was injected. The patient is also weak and tired. Other than the tetanus shot this is the worst thing that has ever happened to the her. The patient was told that if she is having this reaction then she is afraid of getting the second shot. The patient has given childbirth twice naturally and that was nothing compared to this. The patient still can't lift her arm, she feels like she has been shot with a gun, the bone marrow almost hurt. It is hard to say with the patient feeling weak and tired, she is pretty active at work and it was hot outside. The patient can't move her left arm. The patient had to call out of work today because it just wasn't happening ,can't sleep on her left side and has been tossing and turning. She stated when she woke up from the bed in the morning that couldn't lift her arm after receiving the vaccination and pain is an 8.5 on a scale of 1-10, she had taken Advil she stated that it didn't worked she bought the medication 5 weeks ago and product was described as Equate Ibuprofen, a bottle of 500 because of the reaction she was afraid to take the second dose of vaccination . Treatment was given for swelling, redness, pain in arm as Advil and ice. The outcome of the events asthenia, fatigue was not recovered and for all other events unknown. Follow-up attempts are needed. Information on the lot/batch number has been requested.
52 2021-07-04 peripheral swelling headache joint pain blurred vision tiredness diarrhea swelling feet numbness shortness of breath
52 2021-07-06 swelling face bp decreased; lightheadedness; facial swelling; lip swelling; tongue swelling; This is a spontaneous... Read more
bp decreased; lightheadedness; facial swelling; lip swelling; tongue swelling; This is a spontaneous report from a non-contactable other HCP. A 52-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6207) via an unspecified route of administration on 18Mar2021 as dose 2, single (at the age of 52-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. On 18Mar2021, during her 15 minute waiting period after the injection, the patient began to experience lightheadedness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, After rest and water, her bp decreased, still not normotensive. She felt like her dizziness was subsiding until we stood her up. Blood pressure increased. She sat back down, given more water, pb and cracker and lozenge. The reported seriousness of the adverse events was non-serious. At 11:21 she reported lightheadedness was mild. She was ambulated around bay but reports increased lightheadedness/dizziness. No sob, cp was reported. Patient feels well overall otherwise. Dizziness, facial swelling, lip swelling and tongue swelling were to be observed. On an unspecified date in Mar2021, the outcome of the event blood decreased was resolved while that of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between BNT162B2 and the reported blood pressure decreased cannot be completely excluded based on information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
52 2021-07-06 swelling, fluid retention, swelling face I cannot breathe; Nasal congestion; Swelling face; Hoarseness; Sob; Ear congestion; Swelling/fluid r... Read more
I cannot breathe; Nasal congestion; Swelling face; Hoarseness; Sob; Ear congestion; Swelling/fluid retention; Swelling/fluid retention; Bags under my eyes; A severe migraine; Massive headaches; Severe joint pain; This is a spontaneous report from a contactable other health care professional nurse. This nurse (patient) reported that a 52-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: ew 0179), dose 2 via an unspecified route of administration, administered in left arm on 21May2021 17:15 (Age at vaccination 52 years) as dose 2, single for covid-19 immunization. Medical history included autoimmune disorder (told i need genetic testing to figure out which one) , Allergy to antibiotics (all oral antibiotics), Latex allergy, Shellfish allergy (fish/shellfish), Allergy (preservatives in meds, demerol/codeine/antifungals, met allergy meds), Kidney stone and Avascular necrosis of bone (AVN bilateral hips). Concomitant medications included oxymetazoline hydrochloride (CLARITIN ALLERGIC). The patient previously took codeine, demerol and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unknown route of administration on Apr2021 at 05:15 PM in Arm Left (Batch/Lot number : ew0171) as dose 1, single for covid-19 immunization. On 22May2021 12:00 AM, the patient experienced i cannot breathe; nasal congestion; swelling face; hoarseness; sob; severe joint pain; ear congestion; swelling/fluid retention; massive headaches; bags under my eyes and a severe migraine. Patient was received steroids, steroid nasal spray and antihistamine as treatment for events. It was reported that if patient do not take prednisone patient get a severe migraine, extremely hoarse, swollen face and patient cannot breathe and joint pain severe. Patient had an auto immune problem and multiple drug allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient was received medications within 2 weeks of vaccination (Claritin). The clinical outcome of all events were not recovered. No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event dyspnea and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
52 2021-07-08 lymph node pain, lymph node swelling Tingling/paraesthesia/paraesthesia in leg,foot/paraesthesia in arm, hand; numbness; fever; chills; s... Read more
Tingling/paraesthesia/paraesthesia in leg,foot/paraesthesia in arm, hand; numbness; fever; chills; severe headache; swelling painful lymphnodes on neck; swelling painful lymphnodes on neck; stumbling/Trouble walking; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration, administered in Left arm on 02Mar2021 at 13:15 (at the age of 52 years) as Dose number Unknown, Single for COVID-19 immunization.The patient's medical history included environmental pollen and some fruit, nuts and soy along with Severe allergies and asthma, Cranial nerve palsy after viral cold and Trigeminus neuralgia. Patient's Concomitant medications were not reported. Patient did not receive any other vaccines within 2 or 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination.1 hour after injection, on 02Mar2021 at 14:30, the patient experienced Tingling, numbness and paraesthesia in leg, foot, arm and hand on left side of body. Followed by fever, chills, severe headache and swelling painful lymph nodes on neck.1 week after vaccination, no improvement on numbness in leg and foot but spreading over to right side as well. Trouble walking and stumbling at times.AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.No treatment received.The outcome of the events was not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
52 2021-07-08 lymph node swelling, peripheral swelling, swelling Fever 102, whole body pain, malaise, dizziness, heart palpitations, rapid heart rate, swollen left a... Read more
Fever 102, whole body pain, malaise, dizziness, heart palpitations, rapid heart rate, swollen left arm, swollen left neck, swollen arm pit, lymphnode swelling, nausea, sweating, elevated Blood pressure, brain fog
52 2021-07-08 peripheral swelling This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnan... Read more
This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient was allergic to penicillin. Concomitant medications were reported as no. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since having the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 25Mar2021 at 08:00, the patient experienced itching started in hands and progressively moved up arms. Hives on hands and arms, extreme itching. Hives moved to legs and feet with extreme itching. Hands are very red and hands are swollen. The patient received antihistamine treatment for reported events. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the reported events itching started in my hands and progressively moved up my arms, hives on hands and arms, hands are very red and hands are swollen was unknown. No follow-up attempts are possible; information about lot number cannot be obtained.
52 2021-07-08 peripheral swelling Pfizer-BioNTech COVID 19 Vaccine EUA Arm is warm and sore since 7/7/2021. On 7/9/2021 noticed sligh... Read more
Pfizer-BioNTech COVID 19 Vaccine EUA Arm is warm and sore since 7/7/2021. On 7/9/2021 noticed slightly swollen pink circle area down my arm
52 2021-07-08 swelling face Facial swelling and tingling both cheeks and nose. Nausea, Chills, no fever, tiredness, joint pain, ... Read more
Facial swelling and tingling both cheeks and nose. Nausea, Chills, no fever, tiredness, joint pain, muscle pain, headache. Stiff neck on left side, same side as injection site. Arm soreness at injection site
52 2021-07-08 swelling face left sided facial swelling, redness, severe pain started 06/30/2021,. Went to ER 06/03/2021 treated... Read more
left sided facial swelling, redness, severe pain started 06/30/2021,. Went to ER 06/03/2021 treated with Kflex QID without improvements
52 2021-07-10 swelling Swelling under left armpit into left breast area; shoulder blade area feels like a stiff neck sore t... Read more
Swelling under left armpit into left breast area; shoulder blade area feels like a stiff neck sore to turn head to the left; shoulder and shoulder blade very sore on left side wrist up to neck back; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199), via an unspecified route of administration in the left arm on 04Mar2021 at 19:30 (at the age of 52-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration in the left arm on 25Mar2021 at 19:30 (at the age of 52-years-old), as single doses for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Mar2021 at 05:00, the patient had swelling under left armpit into left breast area, shoulder and shoulder blade was very sore on left side wrist up to neck back and shoulder blade area felt like a stiff neck, sore to turn head to the left. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events swelling under left armpit into left breast area, shoulder and shoulder blade very sore on left side wrist up to neck back and shoulder blade area feels like a stiff neck sore to turn head to the left. The clinical outcomes of the events swelling under left armpit into left breast area, shoulder and shoulder blade very sore on left side wrist up to neck back and shoulder blade area feels like a stiff neck sore to turn head to the left were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected
52 2021-07-12 guillain-barre syndrome Diagnosis sensory ganglionopathy following a "GBS like" episode.; Onset of tingling/numbness the day... Read more
Diagnosis sensory ganglionopathy following a "GBS like" episode.; Onset of tingling/numbness the day following 2nd covid vaccine; Onset of tingling/numbness the day following 2nd covid vaccine; Diagnosis sensory ganglionopathy following a "GBS like" episode.; This is a spontaneous report received from a contactable consumer (patient). This 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0170) via an unspecified route of administration on 20Apr2021 at 09:45 (at 52-year-old), at single dose for COVID-19 immunization. Medical history included seasonal allergy gadolinium contrast MRI and allergic to metal (Nickel). Concomitant medications included vitamin b complex taken for an unspecified indication and ergocalciferol (Vit D) taken for an unspecified indication. It was mentioned that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8734) via an unspecified route of administration on 30Mar2021 at 09:45 (at 52-year-old), at single dose for COVID-19 immunization. On 21Apr2021 at 01:00 pm the patient experienced diagnosis sensory ganglionopathy following a "gbs like" episode, onset of tingling/numbness the day following 2nd covid vaccine. The patient underwent lab tests and procedures which included gadolinium contrast MRI which showed Known allergies: Gadolinium contrast MRI. On 23 Apr2021 the patient had primary care appointment. On 26Apr2021 she had neurology appointment. On 25Jun2021 she had neurological testing. The patient continued care and was referred to rheumatology. The patient had not recovered.
52 2021-07-12 lymph node swelling Soreness in arm administered; Soreness in neck; Soreness in back shoulder blade; Underarm lymph was ... Read more
Soreness in arm administered; Soreness in neck; Soreness in back shoulder blade; Underarm lymph was swollen and hurting; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6204), via an unspecified route of administration in the left arm on 08Mar2021 at 13:30 (at the age of 52-years-old) as a single dose for Covid-19 immunisation. Relevant medical history included allergies to foods (unspecified) and medications (unspecified). Patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient experienced soreness in arm administered from neck to back shoulder blade. The patient reported that this soreness lasted for two days. On an unknown date in Mar2021, a week after, the patient experienced swollen and hurting underarm lymph. Therapeutic measures were taken as a result of swollen and hurting underarm lymph which included treatment with Tylenol. The patient reported that the pain had started to lessen but was still present. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the event soreness in arm administered from neck to back shoulder blade was resolved on 18Mar2021. The clinical outcome of the events swollen and hurting underarm lymph was resolving at the time of report. No follow-up attempts are needed. No further information is expected.
52 2021-07-13 pancreatitis Friday 4/23 evening: stomach turning began; evening stomach pain intensified; Saturday 4/24: diarrhe... Read more
Friday 4/23 evening: stomach turning began; evening stomach pain intensified; Saturday 4/24: diarrhea began; severe abdominal pain began; abdominal pain intensified with food ; Sunday 4/25 to Monday 4/26: diarrhea and abdominal pain persisted; Tuesday 4/27: diarrhea subsided; abdominal pain; Wednesday 4/28: abdominal pain; regular visit to nutrition response practitioner; supplement schedule adjusted; Thursday 4/29: abdominal pain; Friday 4/30: doctor?s appointment/exam; bloodwork taken; upon physical exam, suspected pancreatitis and prescribed limited diet (broths, crackers) and fluids and to hold on any supplements, prescribed omeprazole and sucralfate; Saturday 5/1: abdominal pain; ultrasound performed; bloodwork/labs did not show elevation of pancreatic enzymes, eosinophils much higher than normal (2,500); Sunday 5/2: abdominal pain persisted, worse when hungry; limited diet; Monday 5/3: abdominal pain; messaging with doctor; called pharmacist who administered vaccine to ask questions; pharmacist consulted with others and suggested to wait until end of six weeks for second dose to assess health at that time, said probably safe, but may cause same reaction with second dose; Tuesday 5/4: abdominal pain; messaging with doctor; Wednesday 5/5: abdominal pain; messaging with doctor; referral to dr. for consultation on endoscopy; suspected ulcer; visit to nutrition response practitioner; resumed limited supplements; Thursday 5/6 to 6/3: Managed pain with adjusted diet and supplements; over this time, consistent pain began to subside; able to add foods back to diet and reach a feeling of being "normal", lost weight; Friday 6/4: Six weeks since first vaccine, did not feel confident to take second dose; Monday 6/7: Called health department for guidance, was told I would have to start over again with first vaccine dose, and that doctor should have complete VAERS form. Feeling better by this time, referral to doctor was made; Monday 7/12: Visited doctor and explained what happened, advised that the situation sounded like enteritis as an immune response to the vaccine; second dose would likely cause similar response.
52 2021-07-15 peripheral swelling Fever lasting two days, pain in the right arm. Significant swelling in hands and feet making it im... Read more
Fever lasting two days, pain in the right arm. Significant swelling in hands and feet making it impossible to grip things with hands. 10 days later, extreme paresthesias in the upper and lower extremities, face, and tongue lasted for two months. The numbness in the tongue and hands continue. Severe shortness of breath is continuing. Respiratory disorder continues, unable to clear my lungs after several Dr. visits and ER visits. Xray of the lungs, however, seems clear.
52 2021-07-16 peripheral swelling DVT blood clot in distal femoral vein. Felt warmth and saw swelling on right leg thigh. Observed for... Read more
DVT blood clot in distal femoral vein. Felt warmth and saw swelling on right leg thigh. Observed for 24 hours before seeking ultrasound which confirmed. Started blood thinners. 2 shots of Lovenox followed by Xeralto the next day. On Xeralto for 6 months.
52 2021-07-17 lymph node swelling, axillary mass Purple small lump inside armpit; Swollen lymph gland under left arm; This is a spontaneous report fr... Read more
Purple small lump inside armpit; Swollen lymph gland under left arm; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER2413) via unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient medical history included hypothyroidism, asthma. The patient had a known allergy to doyxcylene. The patient concomitant medication included leyvothroxine sodium (SYNTHROID) received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9262) via unspecified route of administration in the left arm on 04Mar2021 at 15:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 12:00, the patient experienced swollen lymph gland under left arm and after a week plus days of second shot of vaccination, the patient experienced purple small lump inside armpit. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of swollen lymph glands and axillary lump. The clinical outcome of the events swollen lymph glands and axillary lump was not recovered. No follow-up attempts are needed. No further information is expected.
52 2021-07-18 peripheral swelling SIDE EFFECTS FROM Pfizer- April 5, 2021, Lightheaded, equal Librium issues from top of stair, I?d fa... Read more
SIDE EFFECTS FROM Pfizer- April 5, 2021, Lightheaded, equal Librium issues from top of stair, I?d fall going downstairs like my muscles would give out or I couldn?t control their movement or lose balance, black outs, fatigue, seeing stars as if I was dehydrated. Muscle tightness in my back, legs, buttocks to the point they would lock up, stop working and the pain would be unbearable walking 10? to 15? (I was up to ½ mile walking prior to this) without any notice and I could not move, I would have to wait 15-20 minutes before I could move or just crawl in pain. Spasms throughout my body I cannot control, previous migraines are more frequent, severe, and so debilitating I would stay in bed up to 6 hours with ice on my neck in pure darkness. My dog would have to poop and pee in the house if my neighbor wasn?t home. This is continuing to this day. More in my hips now than other joints but the muscle tightness continues. The only thing that has gone less frequent to less than once a month is spasms have dissipated (July 2021) in time. At the end of July, 2021, Soft tissue damaged areas on my head started from a motorcycle accident from 2008, became so tender to the touch it was impossible to take a shower, my hygiene is suffering which puts my health in danger. The water touching my head would bring me to tears, I went from showering every day to once a week. I stopped going to the chiropractor because it hurts to be touched. I cannot lay down or sit more than a few minutes at a time, I use Lidocaine mixed with CBD balm all over my body and scalp. Memory fog, forgetfulness, confusion, double vision, major hair loss, bumps on my skin, tender stomach, shortness of breath without humidity and inside with air conditioner on (very rare for me), legs show signs of swelling, tingling, continual extreme numbness in my extremities, I?ve broken all my coffee cups, I?ve tried to get up and have fallen because I didn?t realize my legs were numb after sleeping or sitting. All my joints, bottom of my feet, heels neck shoulders. After going to the bathroom, I?m washing my hands, and if I don?t sit back down on the toilet, I will pee myself immediately. These side effects started around mid- May 2021 and have not gone away and stabbing chest pain on the left shoulder/neck area kinda like cardio spasms around my heart that go away after 15-30 second but excruciating pain happening 2-3 within a week waking me up I started Online Virtual classes in December 2020, one on one weekly courses with a therapist/case manager and weekly group courses , and completed them in June 2021. I elected to Virtual classes due to cancelled bed dates since beginning of 2019 due to COVID. I felt like a new person ready to start ?living for the first time? and get out and into a place with no humidity. Better for my health was my concern. It took watching the news once with massive destruction going on, children being killed by drive by shootings, fires destroying buildings and businesses I once visited, places I?ve where with my sister worked as a hair stylist, and brother used to live when we talked. So much hate, what happened to the world while I was fixing myself to be mentally healthier and vaccinated to be able to rejoin the community again? Since July 2021, I feel like something inside me snapped, broke ? the media coverage, the center misleading or changing COVID reports, leader doing nothing to stop the racism/hate damage control and deaths, has taken away all my hard work away from me! The misunderstanding of COVID, the vaccine side effects has scared to into believing I cannot leave my home, or I will die.
52 2021-07-20 peripheral swelling, lymph node swelling Swelling vaccinated arm (3-4 circumference); Redness; Swollen lymph nodes in arm pit; Joint pain; Mu... Read more
Swelling vaccinated arm (3-4 circumference); Redness; Swollen lymph nodes in arm pit; Joint pain; Muscle pain; Tired; Dizzy; Hot to touch; This is a spontaneous report from a contactable consumer, the patient. A 52-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 28Mar2021 at 10:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included covid-19 in march2020, DVT (deep vein thrombosis), pulmonary embolism, depression, migraine, cluster headaches and vocal cord dysfunction. The patient was allergic to steroids, tetanus, Compazine, apples and pineapple. Concomitant medications included sertraline hydrochloride (ZOLOFT) started on an unknown date for unknown indication, rivaroxaban (XARELTO) started on an unknown date for unknown indication, gabapentin (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication, verapamil hydrochloride (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication, olanzapine (OLANZ) started on an unknown date for unknown indication and pantoprazole sodium sesquihydrate (PROTONIX) started on an unknown date for unknown indication received within 2 weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 10:30 the patient experienced swelling in the vaccinated arm (3-4 circumference), redness, hot to touch, swollen lymph nodes in arm pit, joint pain, muscle pain, tiredness and became dizzy. The event resulted in emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events swelling arm, redness, swollen lymph nodes, joint pain, muscle pain, tiredness, dizzy and warm skin were not recovered. No follow-up attempts are needed. No further information is expected.
52 2021-07-21 sepsis Patient presented to the ED on 4/27/2021 with aphthous ulcer of tongue. Patient presented to the ED ... Read more
Patient presented to the ED on 4/27/2021 with aphthous ulcer of tongue. Patient presented to the ED on 5/30/2021 with sepsis and hyperlactatemia. These visits are within 6 weeks of receiving first dose of covid vaccination.
52 2021-07-22 swelling the right side of my neck swelled up; I could not speak or think properly; I could not speak or thin... Read more
the right side of my neck swelled up; I could not speak or think properly; I could not speak or think properly; blood pressure was 177 over 80 and kept going up/got to 205 over 100 and they took me to the hospital and it took 3 hours for it to get to a reasonable number of 149 over 80/blood pressure this high; feeling bad; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: er2613), via an unspecified route of administration on 23Mar2021 12:15 (at the age of 52-years-old) at dose number unknown, single in the left arm for COVID-19 immunisation. Medical history included corn allergy and asthma. The patient was allergic to lots of products in the store. The patient has a safe list from her dermatologist so she knows what kind of shampoo, clothes detergent, etc. she can buy. The patient had no COVID prior vaccination, was not tested for COVID post-vaccination, and was not pregnant at the time of vaccination. Concomitant medications included losartan and citalopram. The patient previously took lisinopril, lactose, and ammonia, and experienced allergies. The patient was vaccinated in a public health department. On 23Mar2021 12:15, the patient started feeling bad immediately. The patient stated, " they asked me to back up and I went left and ran over an orange cone that got stuck under my Prius because I misunderstood them". On 23Mar2021 12:15, the patient's blood pressure was 177/80 and kept going up. The patient's blood pressure got up to 205/100. The patient was brought to the hospital on 23Mar2021 and it took 3 hours for it to get to a reasonable number of 149/80 so the patient could go home. The patient never had her blood pressure this high. The patient was not anxious about getting the shot at all and felt normal before hand and these all happened very quickly. The patient will not get the second dose because she doesn't want to have a stroke. The next morning, on 24Mar2021, the patient's right side of her neck swelled up and she could not speak or think properly. It was reported that the events resulted in emergency room/department or urgent care visit. It was unknown if patient was given treatment for the events. Outcome of the events blood pressure high was recovered on 23Mar2021, and for other events was recovered on an unspecified date in 2021. Follow-Up (22Jul2021): Follow-up attempts are completed. No further information is expected.
52 2021-07-23 swelling, lymph node swelling My left arm where the injection was had swollen three times the normal size; Swelling; Dizzy; I used... Read more
My left arm where the injection was had swollen three times the normal size; Swelling; Dizzy; I used cold compress to stop itching and swelling; Lymphadenopathy; Arm Pain; Vomiting; Headache; Diarrhea; Muscle pain; Joint Pain; Nausea; Rash at the injection site; rash on the arm; Fever of 99.9; Fever of 101; This is a spontaneous report from a Contactable Consumer reported for self. This 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in Arm Left on 28Jun2021 17:00 at the age of 52-year-old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included COVID. Concomitant medication included hormone medication, It is Best 3 milligram, T 2 Milligram topical cream (Name not confirmed hence not captured in tab) and taking Progesterone 200mg. She felt great for 12 hours, like 5 O' Clock the next day (29Jun2021 5:00) left arm where the injection was had swollen three times the normal size. She had started getting a fever of 99.9 (29Jun2021) and she started getting dizzy, nausea, vomiting and diarrhea. It persisted for 14 days, the swelling on 29Jun2021, the headache, the muscle pain, the joint pain, the fever of 101 and the rash at the injection site and the lymph node, lymphadenopathy, diarrhea, vomiting and arm pain on 29Jun2021. So, every side effect that was documented as a side effect, had a rash on the arm that look like a flower and its incitingly. Treatment included took Benadryl to stop swelling but don't know if it helped, it took 4 days for the swelling to stop and used cold compress to stop itching and swelling. Lab data included had a full hormone panel and CBC Diffs (Unclear and not clarified) test were normal. Cholesterol and sugar were great, everything was great, except hormone. Outcome of the event Arm Pain, Lymphadenopathy, Rash at the injection site; rash on the arm, Joint Pain, Muscle pain, Headache, Diarrhea, Vomiting, Fever of 99.9; Fever of 101, Swelling was recovered in Jul2021. Outcome of other events was unknown. Information on the lot/batch number has been requested.
52 2021-07-24 peripheral swelling I had nausea, fever, swelling of left arm and armpit. Pain and discomfort in the arm where shot was ... Read more
I had nausea, fever, swelling of left arm and armpit. Pain and discomfort in the arm where shot was given came on and off. On May 26, 2021, I develop a strong pain from the left side of my neck to my elbow. Decided to see my physiatrist because I couldn't stand the pain. Got X-Rays and an MRI of the area but nothing came out in them. My physiatrist recommended therapy and medicine and after about a month, I started to feel some relief. About a week later, i noticed I had a rapid heartbeat and was feeling more tired than usual, and went to see Dr., he ordered a battery of tests.
52 2021-07-25 lymph node swelling Left arm was tender, lymph node under arm begin to get bigger the size of a golf ball, left leg feel... Read more
Left arm was tender, lymph node under arm begin to get bigger the size of a golf ball, left leg feels as though there is a continous charlie horse there.
52 2021-07-26 lymph node swelling On April 9th, 2021, I developed body inflammation and especially in the lower abdomen. I waited it ... Read more
On April 9th, 2021, I developed body inflammation and especially in the lower abdomen. I waited it for about a month until I had to contact my OBGYN, in early June 2021, because I started to feel pain in my lower abdomen and I noticed that a hernia was developing as well and swelling in my lymph nodes in my groin area. Dr. did an ultrasound of my uterus and ovaries to check for swelling, and the results came back normal urine test to check if I had a urine infection but that was negative. My general practitioner, ordered me an MRI for August 11, 2021, to check the swelling in my abdomen.
52 2021-07-27 lymph node swelling Sore and pin in arm of vaccination site for 7 days; Swollen lymph nodes in arm pit and neck (lympha... Read more
Sore and pin in arm of vaccination site for 7 days; Swollen lymph nodes in arm pit and neck (lymphadenopathy) under vaccination arm for more than 14 days; Sore throat; tired; Inappropriate schedule of vaccine administration; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on 03Jul2021 at 23:30 as dose 1 single and second dose (Lot number- Pfizer Evvo198 RX5449) via an unspecified route of administration in upper left arm on 03Jul2021 as dose 2 single for COVID-19 immunization. Patient's age at vaccination was 52-year-old). Medical history included Graves' disease, allergic to peanuts, Clidomiocin. Patient previously took Tapazol, Aspartame and experienced allergy. Concomitant medications included levothyroxine sodium (SYNTHROID), amitriptyline. COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. On 05Jul2021, patient experienced sore and pin in arm of vaccination site for 7 days, swollen lymph nodes in arm pit and neck (lymphadenopathy) under vaccination arm for more than 14 days, sore throat and tired for a week. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the adverse events. The outcome of the events was recovering.
52 2021-07-27 lymph node swelling I got little dizzy; I had swollen glands like my throat was really swollen then, I got extremely diz... Read more
I got little dizzy; I had swollen glands like my throat was really swollen then, I got extremely dizzy and had my ears were completely clogged; I had diarrhea and my skin was hurt; My ears like tearing me; have an ear infection your ear is full of fluid and your ear is very swollen and it's probably inflammation from the Vaccine; I got little dizzy; I had swollen glands like my throat was really swollen then, I got extremely dizzy and had my ears were completely clogged; I got little dizzy; I had swollen glands like my throat was really swollen then, I got extremely dizzy and had my ears were completely clogged; I had diarrhea and my skin was hurt; my heart was beating really fast; Throat was really tight like it's going to clogged; I am allergic to ingredients in the Vaccine; I just felt really weird; stomach hurt; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Right on 26Apr2021 (at the age of 52-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in Arm left on 05Apr2021 as single dose for covid-19 immunisation and experienced little dizzy, swollen glands, my throat was really swollen, ears were completely clogged, diarrhoea and my skin were hurt and allergic reactions. Patient reported I got my second Vaccine on 26Apr2021 and I didn't feel dizzy at all, when got my Vaccine the next day I woke up and my throat was swollen that I was when I swallowed like I am swallowing gland it that's how my glands were, I didn't only feel dizzy a little bit and then I had diarrhoea my stomach was hurt and I just know that but I thought that was side effects so I wasn't worry about it right, second one supposed to be worried and since then a weekend by my ears like tearing me so, I went to the doctor and I point that I had gone COVID Vaccine this is what happened and like why do I have this so it's been a week and the doctor checked my ear and said you have an ear infection your ear was full of fluid and your ear was very swollen you just have an ear infection and it's probably inflammation from the Vaccine, so they gave me amoxicillin for seven days, so seven days goes by I don't feel any better you know my ears still hurt but like my ears are clogged ,my throat still swollen, I had those white things in my throat it's not getting better so I see an ear doctor and he was like you don't have ear infection anymore you are fine just wait a week it will probably go away so another week and it doesn't go away so then, I see another ear doctor they gave hearing pass my hearing physically normal then they took hear testing in my ears and my nose and they told me we don't see anything and it is to ear super congested, I was like not congested my nose so fine right, so am I got my throat and my ear, my throat was really tight I kept saying that and then they said well we don't see anything just take some Flonase which was nasal spray it's a steroid on Saturday this pass Saturday, I woke before in the morning and throat was really tight like it's going to clogged and my heart was beating really fast and I just felt really weird so, I went to the emergency room and they said, they did a COVID test just to be sure they didn't think, I had COVID they told me that I had a systemic allergic reaction and that one of symptoms of an allergic reaction is your ears being clogged apparently he said I am allergic to ingredients in the Vaccine and I went to four doctors and none of them knew I was allergic reactions isn't that great so I guess I am allergic to the 'pack so I got a steroid shot and now all my symptoms are gone. Consumer stated I am not getting the shot again because, I am allergic to it but hopefully I can take that I have to find out for my administration next year yes there is not intelligence to taking that again because I am allergic to it. Patient visited to physician's office for the event ear infection and emergency room for the events throat was really tight, heart was beating really fast and felt really weird. The patient underwent lab tests and procedures which included heart rate: my heart was beating really fast on unspecified date. Therapeutic measures were taken as a result of the events with Flonase (nasal spray), amoxicillin and steroid shot. The outcome of the events was reported as recovered on unspecified date in 2021. Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021611507 similar report from same reporter
52 2021-07-27 swelling, lymph node swelling Severe headache; Left ear pain radiating to neck; Left ear lid was swollen; Neck swollen; Red neck; ... Read more
Severe headache; Left ear pain radiating to neck; Left ear lid was swollen; Neck swollen; Red neck; left ear lid was red; Enlargement of lymph nodes on the left side of the neck it lasted for 2 weeks; Ringing of both ears; Body pain; This is a spontaneous report from a contactable healthcare professional, a nurse. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an intramuscular route of administration in the left arm on 02Mar2021 at 10:45 (at the age of 52-yeas-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, blood pressure high and hypersensitivity lung disease. The patient previously received sulfa (MANUFACTURER UNKNOWN) and penicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Concomitant medications included insulin glargine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), Mutivitamines (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN) all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an intramuscular route of administration in the left arm on 08Feb2021 at 12:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021 after the first day of second dose of vaccine, the patient experienced body pain and again after one week. On 09Mar2021 the patient experienced severe headache, left ear pain radiating to neck, left ear lid/neck swollen and red, enlargement of lymph nodes on the left side of the neck which lasted for two weeks, then intolerable pain, medication for a week followed by intermittent pain with and without pain medications (duexis and gabapentin). Took omicef for the first week then levaquin for next week with antiviral (aclovior) and ringing of both ears. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had received pain medications/ antibiotics, antivirals for the adverse events. On an unknown date, the patient underwent computed tomography of the head and the result was negative, underwent aspartate aminotransferase (AST) investigation and the result was increased liver enzyme aspartate aminotransferase and underwent abdominal ultrasound (Abd) and the result was pending. On 12Mar2021, the patient underwent rapid COVID-19 virus test and the result was negative. The clinical outcome of the events body pain, severe headache, left ear pain radiating to neck, left ear lid/neck swollen and red, enlargement of lymph nodes and ringing of both ears was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
52 2021-07-27 swelling Headache; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; a... Read more
Headache; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; hot to the touch; pain and soreness on the injection site and arm; dry mouth; very thirsty; nauseouseness; some Pins and needless on my left arm/hand,face, neck and torso; Fatigue were I need to lay down and sleep; Mild shortness of breath like if I've been running and need to stop and catch my breath; Some mild diarrhea; This is a spontaneous report from a contactable consumer(patient). A 52-year-old non pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EN6200), via an unspecified route of administration on 05Mar2021 at 13:30 (at the age of 52-year-old) into left arm as a single dose for COVID-19 immunization at Public Health Clinic. The patient medical history Rheumatoid Arthritis, Fibromyalgia, Spinal Disk Compression. Concomitant medication(s) included calcium; levothyroxine; multivitamin. The patient had allergies to Penicillin, Sulfate Drugs, NSAIDS, Latex. The patient previously took Percocet, codeine and experienced allergy. On 05Mar2021 at 09:30 PM, the patient experienced Headache, a red lump with swelling, then itchy traveling redness around the arm, hot to the touch, pain and soreness on the injection site and arm, also dry mouth, very thirsty, some nauseouseness and some Pins and needles on my left arm/hand, face, neck and torso. Fatigue where she needs to lay down and sleep. Mild shortness of breath like if she has been running and need to stop and catch my breath, and Some mild diarrhea. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment medications were received for the adverse events. The outcome of the evens was recovering. No follow-up attempts are possible. No further information is expected.
52 2021-07-28 lymph node swelling I got little dizzy; I had swollen glands like my throat was really swollen then, I got extremely diz... Read more
I got little dizzy; I had swollen glands like my throat was really swollen then, I got extremely dizzy and had my ears were completely clogged; I got little dizzy; I had swollen glands like my throat was really swollen then, I got extremely dizzy and had my ears were completely clogged; I got little dizzy; I had swollen glands like my throat was really swollen then, I got extremely dizzy and had my ears were completely clogged; I had diarrhea and my skin was hurt; I had diarrhea and my skin was hurt; I got little dizzy; I had swollen glands like my throat was really swollen then, I got extremely dizzy and had my ears were completely clogged; This is a spontaneous report from a contactable consumer or other non-HCP. A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8737), via an unspecified route of administration, administered in Arm Left on 05Apr2021 as DOSE 1, SINGLE (at the age of: 52-year-old) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 05Apr2021 the patient experienced she got little dizzy; on 06Apr2021 she had swollen glands like her throat was really swollen then, she got extremely dizzy and had her ears were completely clogged. On 06Apr2021 the patient experienced she had diarrhea and her skin was hurt. The outcome of all events was recovered on Apr2021. Treatment was given for the reported events as steroid shot. Follow-up (05Jul2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021611449 similar report from same reporter
52 2021-07-28 lymph node swelling Felt like being in a fog; Dizziness; Very weak; Tiredness; Bad headache; Muscle pain; Chills; Fever ... Read more
Felt like being in a fog; Dizziness; Very weak; Tiredness; Bad headache; Muscle pain; Chills; Fever from 100 to102.7 for 10 hours; Severe joint pain; Nausea; Swollen lymph nodes; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 01Apr2021 at 17:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and hypothyroidism. The patient had a history of allergy to sulfa. The patient had received medication within two weeks of vaccination which were unspecified. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 11Mar2021 at 17:15 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 17:45, the patient experienced tiredness, bad headache, muscle pain, chills, fever from 100 to102.7 (units not specified) for 10 hours, severe joint pain, nausea, swollen lymph nodes, dizziness, very weak and felt like being in a fog. The symptoms went on for 72 hours and reported that 108 hours after the 2nd dose the patient still felt very tired and had a few aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events tiredness, bad headache, muscle pain, chills, fever, severe joint pain, nausea, swollen lymph nodes, dizziness, very weak and felt like being in a fog was recovering at the time of report. No follow-up attempts are needed. No further information is expected.
52 2021-07-29 lymph node swelling, lymph node pain Painful lymph node on left collar bone; Swollen lymph node on left collarbone; This is a spontaneous... Read more
Painful lymph node on left collar bone; Swollen lymph node on left collarbone; This is a spontaneous report from a contactable other healthcare professional, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 26Mar2021 at 09:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa (sulfonamide) allergy. The patient did not receive any medication within two weeks of the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Apr2021 at 09:00, approximately 6 days after the first dose, the patient experienced a very painful and swollen lymph node on left collarbone. The event did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event very painful and swollen lymph node on left collarbone was resolving at the time of this report. No follow-up attempts are needed; information about lot number cannot be obtained.
53 2021-01-02 lymph node swelling I noticed swelling of the lymph nodes under my left armpit, when i called my doctor's office the nur... Read more
I noticed swelling of the lymph nodes under my left armpit, when i called my doctor's office the nurse told me to put ice for 20 minutes. Ice was applied every day for 20 minutes, the swelling finally went down some today but the vein under my left arm is still tender.
53 2021-01-05 c-reactive protein increased In the end of December she developed right wrist pain and some mild swelling, then pain in both arms... Read more
In the end of December she developed right wrist pain and some mild swelling, then pain in both arms from elbows to hands, and then it started in the back on her thighs in hips bilaterally and her right ankle. She still has the headache that is unchanged x 1 month, but the other symptoms were new, and she had never had them before. She still has it and it is 1/6/21.
53 2021-01-05 peripheral swelling States she had swelling in her forearm and hand
53 2021-01-05 swelling face FEVER, BODY ACHES, AND FACIAL SWELLING started at 1200 on 01/06/2021. took 400 mg po motrin and 25 m... Read more
FEVER, BODY ACHES, AND FACIAL SWELLING started at 1200 on 01/06/2021. took 400 mg po motrin and 25 mg po bendaryl. At 4am took and additional 25 mg Benadryl po. and at 1000 took third dose of benadryl po 25 mg. Pt. states that he left eye is watering. Pt. states that she has a little bit of facial swelling still at 1023 am on 1/6/2021.
53 2021-01-06 lymph node swelling Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injectio... Read more
Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injection site swelling, injection site redness, nausea, swollen lymph nodes, sneezing, runny nose, dizziness and weakness, and slight chest pressure. Symptoms came and went but the palm sized redness and swelling at the injection site with extreme itching continues to this day. Used cold compresses, topical lotion for allergies, and Vaseline but nothing helped. Will try Benadryl.
53 2021-01-07 lymph node pain, lymph node swelling swollen/sore lymph node in left neck/clavicle area after about several days; swollen/sore lymph node... Read more
swollen/sore lymph node in left neck/clavicle area after about several days; swollen/sore lymph node in left neck/clavicle area after about several days; This is a spontaneous report from a contactable nurse (patient herself). A 53-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Solution for injection; lot number: EL0140; expiration date: not known), via an unspecified route of administration on 24Dec2020 08:00 (left arm) at single dose for covid-19 immunisation. Medical history included depression, hypertension (HTN), and high cholesterol. The patient had allergies with sulfa and beta blockers. The patient's concomitant medications were not reported. The patient previously took pravastatin sodium (PRAVACHOL) and experienced allergies. The patient was vaccinated at a hospital and was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2 vaccine and received other medications within 2 weeks of vaccination but were unspecified. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced swollen/sore lymph node in left neck/clavicle area after about several days on an unspecified date (reported as "01Dec2020", pending clarification). The reported events were non-serious. The patient did not receive treatment for these reported events. The outcome of the events was not recovered.
53 2021-01-07 lymph node swelling, peripheral swelling, lymph node pain 1/6/21: Received vaccine without any immediate reaction around 12:20pm. Took ibuprofen 400mg with di... Read more
1/6/21: Received vaccine without any immediate reaction around 12:20pm. Took ibuprofen 400mg with dinner that evening anticipating some body aches (which i had for 24h after dose 1). 1/7/21: Woke in the early AM with severe arthralgia, myalgia, restlessness, mild R arm swelling. Ate a small snack and took ibuprofen. All day 1/7/21: fatigue, myalgia, arthralgia (all of my large and small joints, my long bones, my intercostals, my large muscles stiff/ ached), and increasingly swollen R axillary lymph node(s) about the size of a large egg, extending into my upper chest. Food aversion at breakfast - could not tolerate eating more than a few bites. Slept almost all day except to re-dose ibuprofen and take a warm shower. Tolerating bland diet by evening. Tmax 99.3F forehead As of now 10:30am 1/8/21, myalgias are improving. Fatigue continues but is less. R axillary and chest lymph nodes are painful and swollen, up into my lower neck. Continuing to take ibuprofen with some food 3x per day
53 2021-01-07 peripheral swelling Headache; Sore arm; Swelling of the feet; This is a spontaneous report from a contactable consumer (... Read more
Headache; Sore arm; Swelling of the feet; This is a spontaneous report from a contactable consumer (patient herself). This 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 23Dec2020 at single dose for COVID-19 immunisation. She was working as a receptionist in a nursing home. Age at vaccination was 53-year-old. No relevant medical history and concomitant medications were provided. On unknown date after vaccination, the patient developed headache, sore arm, and swelling of the feet. The outcome of the events was unknown. Information on the lot/batch number has been requested.
53 2021-01-07 peripheral swelling My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; I... Read more
My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; It is just red and swollen and warm; This is a spontaneous from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included hypertension. Concomitant medication included lisinopril for hypertension. On an unknown date, her arm was rather red and huge almost looks like a, not a Hematoma but its about that big. She didn't feel bad otherwise. It was just red and swollen and warm. The outcome of the event was unknown.
53 2021-01-08 lymph node swelling, swelling Swelling on my neck shoulder axillary and chest on same side as injection site along with swelling a... Read more
Swelling on my neck shoulder axillary and chest on same side as injection site along with swelling and pain at the injection site And under my arm. I have also had insomnia.
53 2021-01-08 lymph node swelling 1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes... Read more
1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes left inguinal, fever of 102.3F, diaphoresis, chills, flushed face, change of taste and baseball sized swelling to injection site.
53 2021-01-08 swelling, lymph node swelling Left arm pit lymph node swelling, left side swelling
53 2021-01-10 lymph node swelling 1/8/21 AM headache over the eye, injection site sore arm; PM body aches, chills and shivering, fever... Read more
1/8/21 AM headache over the eye, injection site sore arm; PM body aches, chills and shivering, fever 107., joint pain --over the counter ibuprofen no relief, weakness in legs. 1/9/2021 body aches and fever resolved. Fatigue, weakness and joint pain, Tylenol --some relief. Swollen lymph nodes in left armpit and soreness; low back pain, shooting hip pain.
53 2021-01-10 lymph node swelling lymphadenopathy under right arm. still on going today
53 2021-01-10 swelling face At 8:00 pm, approximately 36 hours after my second COVID - 19 vaccine injection in my left deltoid, ... Read more
At 8:00 pm, approximately 36 hours after my second COVID - 19 vaccine injection in my left deltoid, my left upper lip began swelling. I took a Benadryl as I was already on prednisone. I had no problems during the night except a stuffy nose. On the following morning my face was swollen, more on the left. I took two more Benadryl during the day and on Sunday morning the swelling was gone. I had not other symptoms or complications.
53 2021-01-11 lymph node pain A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 ... Read more
A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 hour later. After 2 hours of the shot, the left arm began to be noticeably sore. 12 hrs post vaccine, I had flu-like symptoms. 24 hrs post vac, flu-like symptoms continued and the injection site had a visibly 2" swollen, red warm circle and raised area; also, I experienced considerable lymph node soreness in left underarm and under jaw (neck area) and itchiness at injection area. 36 hrs post vaccine, the flu-like symptoms subsided, but the injection site continued to grow to 3" red, warm and swollen area. Also I continued to have the itchiness, sore lymph nodes in the left arm (injection arm). Today is 48 hours post vac and I continue to have the red, raised, warm and itchy swollen circle at the injection site with soreness in the lymph node glands on left arm.
53 2021-01-11 lymph node swelling Patient developed supraclavicular lymph node nodule 7 days post vaccination on left side of body. C... Read more
Patient developed supraclavicular lymph node nodule 7 days post vaccination on left side of body. CT scan and biopsy completed 8 days post vaccination. Biopsy was normal/non-cancerous.
53 2021-01-11 swelling I have a red silver dollar sized hard lump that is red and warm
53 2021-01-12 anaphylactic reaction anaphylactic reaction; arm was really sore; tiredness; dizzy; This is a spontaneous report from a co... Read more
anaphylactic reaction; arm was really sore; tiredness; dizzy; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received bnt162b2 (Pfizer-biontech covid-19 vaccine), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunization. Medical history included shellfish allergy. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction on an unspecified date, dizzy on 31Dec2020, arm was really sore on an unspecified date, tiredness on an unspecified date. Event details: She was dizzy that day especially with changing positions, she didn't need to go to the doctor or anything. It wasn't severe. She was just a little dizzy. It's probably just the vaccine and it did go away. Her arm was really sore and went away after a few days. the tiredness, it wasn't a big deal. She did feel better about. it wasn't a serious anaphylactic reaction. It didn't happen right away. She had arm soreness. it wasn't immediate. She usually didn't have. It was really weird. She thought she was well hydrated. The outcome of event was really sore was resolved, outcome of other events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events due to temporal relationship. There is very limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
53 2021-01-12 anaphylactic reaction Anaphylaxis Narrative: After immunization felt nauseated and was diaphoretic, B/P 70/42, HR52, Fio2... Read more
Anaphylaxis Narrative: After immunization felt nauseated and was diaphoretic, B/P 70/42, HR52, Fio2 100%, RR 12. IV 18g started left AC she appeared initially to be a vagal response. NS initiated and then she started complaining of throat issues and not being able to move arms. HR decreased to 40 and 1M epinepherine 0.3mg given left deltoid. Fluids NS rapid infused and 50mg of benadryl given IV. 02 at 10 1pm via none rebreather started. VS 126/67, 84, 20 100% 02 sat. Taken to the ER for further evaluation.
53 2021-01-12 swelling 1ST VACCINATION PRODUCED NO SYMPTOMS AND WAS ADMINISTERED ON 12/21/20 2NS VACCINATION WAS APPROX. 6:... Read more
1ST VACCINATION PRODUCED NO SYMPTOMS AND WAS ADMINISTERED ON 12/21/20 2NS VACCINATION WAS APPROX. 6:30 PM ON 1/11/21 AND SYMPTOMS BEGAN WITH BEING AWAKENED BY FEELING ITCHINESS ON STOMACH AT APPROX 01:30 A.M. ON 1/13/21. PATIENT (I) OBSERVED BUMPINESS AND REDNESS COVERING ENTIRE STOMACH, BACK OF NECK AND ITCHINESS DOWN THIGHS AND ALONG UNDER SIDE OF ARM. TOOK BENADRYL OTC AND WENT BACK TO BED. AWOKE FOR WORK AT 04:30 AND SYMPTOMS ARE BETTER. NO SHORTNESS OF BREATH OR OTHER ALLERGY RELATED SYMPTOMS
53 2021-01-13 lymph node swelling, lymph node pain Severe myalgia; arthralgia; body stiffness; pain/pain under right axilla, extending to right chest a... Read more
Severe myalgia; arthralgia; body stiffness; pain/pain under right axilla, extending to right chest and neck; fatigue; Nausea; food aversion; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; first dose on 18Dec2020 15:30, second dose on 06Jan2021 12:15; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration on 06Jan2021 12:15 in right arm at single dose for COVID-19 immunization. Medical history included ADHD (attention deficit hyperactivity disorder), depression in remission, Known allergies: yes: Nitrofurantoin, cephalexin, penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Concomitant medication included ashwagandha (ASHWAGANDHA), rhodiola rosea (RHODIOLA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 15:30 for COVID-19 immunization. Adverse event on 07Jan2021 01:00: Severe myalgia, arthralgia, body stiffness, pain and fatigue in early AM of 07Jan2021, continuing into 08Jan2021, though improving. Nausea and food aversion on 07Jan2021, Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck still evolving as of this report. Treatment: Ibuprofen OTC, bed rest, warm showers, rest. The outcome of the events was recovering.
53 2021-01-13 lymph node swelling I experienced soreness at the sight of injection, lymph nodes swollen and sore under left arm, body ... Read more
I experienced soreness at the sight of injection, lymph nodes swollen and sore under left arm, body aches, chills, tiredness. I took 2 Aleve before injection and Benadryl 25mg at 9p after injection.
53 2021-01-13 lymph node swelling Lymphadenopathy and fatigue; Lymphadenopathy and fatigue; First dose of BNT162B2 administered on 17D... Read more
Lymphadenopathy and fatigue; Lymphadenopathy and fatigue; First dose of BNT162B2 administered on 17Dec2020 and second dose on 04Jan2021 (18 days apart); This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 04Jan2021 at 10:00 (second dose) on the right arm, and on 17Dec2020 at 15:00 (first dose) on the left arm; both via unspecified routes of administration at a single dose for immunization. Medical history included hypertension and liver disease. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), ibuprofen, paracetamol (TYLENOL), propanol, and sennoside a+b (SENOKOT). The patient experienced lymphadenopathy and fatigue on 05Jan2021 at 05:00. The patient did not receive treatment for the adverse events. Outcome of the events was not recovered.
53 2021-01-14 swollen extremities, lymph node pain, lymph node swelling Day 1- RUE injection site tender Day2- RUE Large knot at injection site, tenderness. Fatigue Day 3- ... Read more
Day 1- RUE injection site tender Day2- RUE Large knot at injection site, tenderness. Fatigue Day 3- Right Axillary lymph nodes swelling, grapefruit size, painful. Edema from injection site to fingertips with numbness to 3,4,5 digits. Fatigue and headache. Day 4- RIGHT sided lymph nodes swelling, palpable to neck, axillary and groin. Severe fatigue. Headache. Edema still complete to RUE- with numbness to fingers. Grapefruit sized axillary, slightly improved. NO FEVER, COUGH, DYSPNEA
53 2021-01-15 lymph node swelling Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very... Read more
Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very big, injection site is harder. Lower back at kidney sites are so painful. Weakness. No energy to lift up arms or legs. Have difficult to get up and get out of bed to get medicine or food. So sleepy, maybe because Tylenol 500mg q4h to help for pain but reduce just little from 10 down to 8 for a short time enough to get out of bed to get something. Ice pack at armpit, heat pat at lower back but just reduce the pain from 10 down to 9 only. No appetite. Eat lentil and rice porridge but indigestible and have to take Pepcid. All symptoms prolong until Friday 1/15/2021 around 1pm. I pushed myself hard to get up to drive to employee health for testing which I missed on Thursday due to unable to get up. After that the symptoms down to moderate that I able to report CDC. I wonder why 2 dose is so horrible to me.
53 2021-01-17 swollen extremities, lymph node swelling neck lymph node swelling; then 30 hours after receiving vaccine hands turned red and burned, pain an... Read more
neck lymph node swelling; then 30 hours after receiving vaccine hands turned red and burned, pain and swelling in arm pits. currently have increased paresthesia arms, hands, legs and feet
53 2021-01-18 lymph node swelling Fever up to 101.0, body aches, chills, fatigue, weakness, redness at injection site, tender at injec... Read more
Fever up to 101.0, body aches, chills, fatigue, weakness, redness at injection site, tender at injection site, swollen lymph nodes in neck, axilla, L breast, headache that started at 6 am the following day. I took Tylenol which did help fever and body aches. I had symptoms until 1/11/21 and started feeling better at 11 am.
53 2021-01-18 lymph node swelling left sided cervical adenopathy
53 2021-01-18 lymph node swelling Malaise, muscle ache, joint pain, abd pain, vomiting, swollen lymph node, headache, lightheadedness,... Read more
Malaise, muscle ache, joint pain, abd pain, vomiting, swollen lymph node, headache, lightheadedness, dizziness. Symptoms improved. Went to ER on 1/16/21, Covid test neg.
53 2021-01-19 swelling face, lymph node swelling ? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swellin... Read more
? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swelling of your face and throat ? A fast heartbeat ? A bad rash all over your body ? Dizziness and weakness
53 2021-01-19 swelling face Started having some blurry vision on the night of 01/17/2021 which lasted for 45 mins to 1 hour. The... Read more
Started having some blurry vision on the night of 01/17/2021 which lasted for 45 mins to 1 hour. The next day on 01/18/2021 at about 1445 started having some itchiness on the face[ cheeks, forehead and around lips] with chills on and off. My face became little puffy and swollen with redness. By the evening, I also ended up with high temperature 100 degree and started having body pain , mainly on the lower back . Took 600 mg Ibuprofen along with Vitamin C 1000 mg and Zinc 1 tablet at night. All my symptoms resolved by 01/19/2021 noon.
53 2021-01-19 swelling Hives beginning at 4 pm on January 17 and progressed to severe itching and swelling. Benadryl and Fa... Read more
Hives beginning at 4 pm on January 17 and progressed to severe itching and swelling. Benadryl and Famotidine taken. Admitted to ED at 4 am on January 18, Prednisone given. Symptoms were improving and discharged at 7 am the same day. Hives and itching were worse and facial edema and rash noted on night of January 18. Treatments included Benadryl and Famotidine. Morning of January 19, 40 mg Prednisone and Benadryl every 4-6 hours. Morning of January 20, hives and rash and itching persists on stomach, legs, arms, and ears. 40 mg of Prednisone and Benadryl. (Present time - hives, rash, and itching still persists with less severity)
53 2021-01-21 lymph node swelling, swollen extremities edematous changes in L axillary region with inflammed lymph nodes
53 2021-01-23 lymph node swelling At around 7pm I began to feel chills, body aches, no fever, injection arm beginning to hurt. During ... Read more
At around 7pm I began to feel chills, body aches, no fever, injection arm beginning to hurt. During the night I woke up because my body was shaking from chills even thought I was under my comforter in a warm room. My injection arm was hurting more and my arm pit of the injection arm felt throbbing and painful. In the morning I still had body aches, temp 99.2, my injection arm and arm pit are painful, my arm pit was swollen. I took 1,000 mg Tylenol. Now at 03:40pm I still have body aches, arm pit still painful but not as swollen as before, chills less frequent, temp 98.4.
53 2021-01-25 peripheral swelling Itching on the right knee and both legs below the knees. Swollen spot below right knee that itches.... Read more
Itching on the right knee and both legs below the knees. Swollen spot below right knee that itches. Right eye is swollen. I took allergy eye medicine , a 24 hour tablet of Allegra, and put Cortizone 10 on my legs below the knees. As of 1/26/2021 - the medicine has stopped the itching, but eye is still slightly swollen.
53 2021-01-25 swelling patient swelled up really large. had to remove rings and clothing. also felt very badly with headach... Read more
patient swelled up really large. had to remove rings and clothing. also felt very badly with headache for the next few days.
53 2021-01-26 lymph node swelling Extreme pain the left arm at Injection site along with swelling of the lymph nodes under the left a... Read more
Extreme pain the left arm at Injection site along with swelling of the lymph nodes under the left arm. Whole body inflammatory response. Treatment: Ice, Tylenol and Hydrocodone. Called physicians office to inform. Awaiting call back if anything needs to be done.
53 2021-01-26 lymph node swelling Fever, headache, chills, dizziness, fatigue, body aches, swollen lymph nodes under arm, cervical ... Read more
Fever, headache, chills, dizziness, fatigue, body aches, swollen lymph nodes under arm, cervical nodes. Started at 2 AM. After vaccine lasted until 1/23/2021
53 2021-01-27 lymph node swelling Had significant painful axillary lymphadenopathy on the injection side; This is a spontaneous report... Read more
Had significant painful axillary lymphadenopathy on the injection side; This is a spontaneous report from a contactable Other HCP. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 11Jan2021 at single dose for COVID-19 immunization. None Medical history. No covid prior vaccination. The patient's concomitant medications were not reported. On 13Jan2021, patient had significant painful axillary lymphadenopathy on the injection side that resulted in doctor/other healthcare professional office visit. No treatment received. The event outcome was unknown. No covid tested post vaccination. Information on the lot/batch number has been requested.
53 2021-01-27 lymph node swelling NauseaVomiting swollen lymph node, fatigue Narrative:
53 2021-01-27 lymph node swelling swollen painful 1cm lymph node under arm near left breast
53 2021-01-28 peripheral swelling Sore arm day one. muscle and joint pain in lower body. Extreme fatigue. swelling in hands and ankle ... Read more
Sore arm day one. muscle and joint pain in lower body. Extreme fatigue. swelling in hands and ankle that is still present.
53 2021-01-31 lymph node swelling, swelling Left Axilla/Underarm pain; Left Axilla/Underarm swelling; lymph node swelling; pain in neck.; Red ra... Read more
Left Axilla/Underarm pain; Left Axilla/Underarm swelling; lymph node swelling; pain in neck.; Red rash on both arms, chest.; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 26Dec2020 14:00 at single dose in left arm for COVID-19 immunization. Medical history included complete thyroidectomy in 2000 and known allergies included Sulfa. Concomitant medications included losartan, levothyroxine, thyroid (ARMOUR THYROID). The patient didn't receive other vaccine in four weeks. The patient had no covid prior vaccination and no covid tested post vaccination. The patient experienced left axilla/underarm swelling/pain, lymph node swelling/pain in neck. Red rash on both arms, chest on 27Dec2020. The patient did not receive the treatment for events. The outcome of the events was unknown. Information on the lot/batch number has been requested.
53 2021-01-31 peripheral swelling swelling and pain of first digit phalangeal-metacarpal joint, R hand, index finger (same side as va... Read more
swelling and pain of first digit phalangeal-metacarpal joint, R hand, index finger (same side as vaccine received)
53 2021-02-01 swelling face Facial swelling, itching, tightness, eyelid dropping
53 2021-02-02 swelling face Within one hour had tingling in right hand, tingling in tips and tongue, flushed and swelling in che... Read more
Within one hour had tingling in right hand, tingling in tips and tongue, flushed and swelling in cheeks, throat tightness and lethargy
53 2021-02-03 peripheral swelling first shot my arms and neck muscles went numb for several hours Second time my legs were in severe ... Read more
first shot my arms and neck muscles went numb for several hours Second time my legs were in severe pain and hard to make move-could barely walk. This lasted for about 8 hours. I had a small fever, my left leg and ankle swelled for several days and hurt mildly. I had a rash on my neck and body. I had fatigue like theonset of a fibro attack both times but second shot was much worst than first.
53 2021-02-07 swelling face SWELLING OF THE FACE AROUND BOTH EYES WITH ITCHING AND LIPS SWOLLEN AROUND SUNDAY MORNING AT 2:00 ... Read more
SWELLING OF THE FACE AROUND BOTH EYES WITH ITCHING AND LIPS SWOLLEN AROUND SUNDAY MORNING AT 2:00 AND BECAME WORSE LATER THAT MORNING. EXTREME TIREDNESS. TOOK BENADRYL TO RELIEVE THE ITCHING AND SWELLING.
53 2021-02-08 lymph node inflammation After receiving my vaccine, I had the normal arm soreness and low grade fever but the following day ... Read more
After receiving my vaccine, I had the normal arm soreness and low grade fever but the following day my fever went up to 102 even after taking Advil every 6 hours. On the 3rd day my arm continued to be sore and my fever continued but was between 100.7 and 101.4. On day 4 my fever started going down to 99 for the day but my arm continued to be sore where the injection was and my armpit was sore as well like something was swollen. Day 5, today, my fever finally broke but my arm has a red circle and knot where the injection was given, its still very sore and also itches and warm to the touch. Every time I raise it up, I get shooting needles in the area of the shot. I have severe fatigue and sweats when I get up to walk anywhere and I feel exhausted. I called and spoke to the nurse who spoke to my Dr. listed on this form. She told me all of my symptoms were normal and said that if I started throwing up or my arm got worse to call back. I was not asked to come in to have anyone look at my arm or see if there is something else going on with the symptoms I am having.
53 2021-02-09 swelling Chills; Body aches; Injection arm began to hurt; Body tremble; Armpit very painful; Arm pit swelling... Read more
Chills; Body aches; Injection arm began to hurt; Body tremble; Armpit very painful; Arm pit swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 23Jan2021 (11:45) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included early diabetes and high blood pressure. Concomitant medications included valsartan, sitagliptin (JANUVIA) and rosuvastatin. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on 02Jan2021 (when the patient was 53 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 23Jan2021 (19:00), the patient had chills; body aches; injection arm had begun to hurt; body tremble; armpit was very painful; and armpit was swelling. The patient had no fever. The patient had taken paracetamol (TYLENOL) as treatment for the reported events. The outcome of the events, 'chills', 'body aches', 'injection arm had begun to hurt', 'body tremble', 'armpit was very painful' and 'armpit was swelling', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.
53 2021-02-10 peripheral swelling, lymph node swelling left arm swollen, lymph nodes swelling headache, dizziness, generalized malaise form head to toe, ch... Read more
left arm swollen, lymph nodes swelling headache, dizziness, generalized malaise form head to toe, chills as well.
53 2021-02-14 lymph node swelling Nearly blacked out/passed out after I woke up on 2/14 Sluggish with chills and aches the rest of the... Read more
Nearly blacked out/passed out after I woke up on 2/14 Sluggish with chills and aches the rest of the day Noticed enlarged lymph node in the left arm pit region on 2/15
53 2021-02-14 peripheral swelling R Arm swelling & discoloration ; pain & redness in area of injection ; non-aphylactic. Area of sweli... Read more
R Arm swelling & discoloration ; pain & redness in area of injection ; non-aphylactic. Area of sweling & erythema on arm measures 8.5x6cm, with deeper nodular area measuring 4x2.5cm - no fluctuance to suggest abscess or soft tissue infection. TX with topical steroids & initate systemic steroids with prednisone x 5days.
53 2021-02-15 lymph node swelling nausea, headache, muscle aches, fatigue, swollen lymphnodes in armpit (left side)
53 2021-02-15 swelling face, oral herpes Cold sore type of reaction under my nose which has now spread to the ball of my nose with swelling
53 2021-02-18 swelling Vital signs: 124/74 right arm, HR 75, Pulse ox room air 99% Patient presented for 1st dose of COVID-... Read more
Vital signs: 124/74 right arm, HR 75, Pulse ox room air 99% Patient presented for 1st dose of COVID-19 Pfizer Vaccine. Post vaccination patient noted left arm pain to elbow and left supraclavicular swelling moving laterally. Noted tingling and pain then swelling in left neck/shoulder area. About size of a baseball. Patient given option to take benadryl 25 mg once before leaving or take it later if she is not improving. She prefers to take it now. Benadryl 25 mg PO x1 given at 1715 self-administered. Patient monitored for a total 40 minutes before being released. History of reaction to flu vaccination that resulted in arm swelling and high fever ~30 years ago. Vancomycin life threatening reaction.
53 2021-02-19 lymph node swelling, swollen extremities Supra clavicle swelling slowly decreasing and mild auxiliary edema resolved
53 2021-02-20 lymph node pain, lymph node swelling Inlarged and sore lymph gland left armpit. If I lay on left side experienced numbness in left arm an... Read more
Inlarged and sore lymph gland left armpit. If I lay on left side experienced numbness in left arm and hand.
53 2021-02-22 anaphylactic reaction Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure w... Read more
Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure was out of control; dizziness does not allow her to go to work; lingering dizziness; Get a tightening in her chest; Fatigue; Left side of temple toward the crown of head she has pressure on the left side of the body; Left side of temple toward the crown of head she has pressure on the left side of the body; lightheadedness; troponin kept increasing; Inflammation around heart; This is a spontaneous report from two contactable consumers or other non health professional (including patient self, a healthcare worker works with patients with lymphomas, a licensed massage/lymphatic therapist). This 53-years-old female received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, Expiry Date: 30Apr2021) at 0.3 ml single dose intramuscular injection in left arm on 22Jan2021 10:28 (also reported as 10:38) for Covid-19 vaccination. Medical history was none (also reported as no patient history). Concomitant drug was none (reported as no other products). Family Medical History Relevant to AE(s) was none. Historical vaccine included flu shot in Nov2020 for immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No other vaccines given the same day or 4 weeks prior. AE(s) following prior vaccinations was none. Patient never had a reaction to any vaccine or shot before. Patent experienced anaphylactic reaction on 22Jan2021, heart enzymes elevated on 22Jan2021, blood pressure was out of control on 22Jan2021, get a tightening in her chest on an unknown date, lingering dizziness on an unknown date, dizziness did not allow her to go to work on an unknown date, inflammation around heart on 22Jan2021, troponin kept increasing on 22Jan2021, fatigue on an unknown date, lightheadedness on an unknown date, left side of temple toward the crown of head she has pressure on the left side of the body on an unknown date. Seriousness for heart enzymes elevated and anaphylactic reaction was hospitalization from 22Jan2021 to 23Jan2021. The events anaphylactic reaction required a visit to Emergency Room, but not Physician Office. The event clinical course was as follows: patient received her 1st dose of the Pfizer vaccine she had an anaphylactic reaction. She was given 3-4 Epis on site (on 22Jan2021) before being transferred to the ER. In the ambulance, she was administered a 4th EpiPen (on 22Jan2021) before getting to the ER, and then admitted to the cardiac unit on 22Jan2021 for observation. Patient also reported Given 3-4 EpiPens on 22Jan2021 and EpiPen auto-injector was Lack of Effect. No Return Sample Received. When she first started having symptoms, her blood pressure was 128/73. When the symptoms got worse her blood pressure started increasing. Her blood pressure was 220/116, they had to admit her to the cardiac unit because her heart enzymes were elevated and her blood pressure was out of control. Her troponin kept increasing and had inflammation around her heart. Her symptoms of anaphylactic reaction went away that same day, 22Jan2021, at the vaccination from her anaphylactic reaction. Patient was discharged and released from the cardiac unit on that Saturday (23Jan2021 ) around 7:30pm. No one could tell her anything about this since she was still having lingering effects and was getting ready to locate a cardiologist and still has tightness in the chest. She mentioned the dizziness did not allow her to go to work. She experiences it on and off, not consistent but less severe than initially. She still had lingering dizziness and she had to drive for a majority of her day and that was concerning. She said that on the left side she will get a tightening in her chest. She said that no one knows what this means moving forward. Patient was concerned about the severity of the reaction and was still not back to normal. She had never had a reaction to any vaccine or shot before and has been in the military. She needed help, direction since she was still not at the full potential to work. She was still fatigued and has tightness of her chest and those are concerns for her. Patient mentioned a part of the symptoms she also had were lightheadedness and dizziness and that started after the vaccine and it's not as severe, but she still had it. On left side of her temple toward the crown of her head she had pressure on the left side of the body and that was the same side where she received the injection, on that left side. Outcome of anaphylactic reaction was resolved with sequel on 22Jan2021. Outcome of heart enzymes elevated was resolved on 23Jan2021. Outcome of blood pressure was out of control was resolved with sequel on 23Jan2021. Outcome of lingering dizziness was resolving. Outcome of left side of temple toward the crown of head she had pressure on the left side of the body, lightheadedness was not resolved. Outcome of tightness in the chest and fatigue was not resolved. Outcome of inflammation around heart and troponin kept increasing was resolved with sequel on an unknown date. Outcome of the other event was unknown.
53 2021-02-22 lymph node pain, lymph node inflammation 2/19/21 – 6:30 pm start feeling fatigue. Right arm carpel tunnel started twitching randomly and fre... Read more
2/19/21 – 6:30 pm start feeling fatigue. Right arm carpel tunnel started twitching randomly and frequently. This continued all evening and all the next day. 2/20/21 – Woke with fatigue, upper arm pain round injection site, muscle pain randomly over body, joint pain in previous arthritic sites. Continued all day randomly. General feeling of tiredness or unwell. Evening the pain worsed, muscles contracting around spine creating spinal pains and severe headaches. 2/21/21 – Woke feeling tired but better. 2/22/21 – In the evening started feeling pain in spine and muscles in middle to upper back and cervical region. Lymph nodes under jaws and side of neck are painful and inflamed. 2/23/21 – woke up feeling better.
53 2021-02-22 peripheral swelling 1st vaccine: Patient reports hives 4-6 hrs later, took Benadryl, itching stopped within 24 hrs, spot... Read more
1st vaccine: Patient reports hives 4-6 hrs later, took Benadryl, itching stopped within 24 hrs, spots remained (upper calf to her knee) 2nd vaccine: talked with her doctor who agreed it was a good idea to preload with Benadryl, she stated that she took several doses for 24 hours after vaccine and thought she was still in the clear. Wed 2/17 hives started at work, itching arms and legs, noticed hives/spots left elbow, several both hips, a few more on legs near previous spots from 1st dose, both fingers swollen and red with some bumps, felt "unwell" and achy "grumpy" for 24-48 hours- took Benadryl, could not take Benadryl 2/19/21 because she had to work, itching is better 2/19 and she feels okay, spots remain.
53 2021-02-24 lymph node pain, lymph node swelling slightly painful swollen lymph node on her left side near the clavicle and it was tender when touche... Read more
slightly painful swollen lymph node on her left side near the clavicle and it was tender when touched; slightly painful swollen lymph node on her left side near the clavicle and it was tender when touched; This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration on the left arm, on 26Jan2021 13:00, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The vaccine was administered at the workplace clinic. The patient experienced having a slightly painful swollen lymph node on her left side near the clavicle and it was tender when touched on 27Jan2021 10:00. No treatment was received for the adverse events. The patient had not recovered from the adverse events at the time of the report. The patient has not been COVID tested post vaccination.
53 2021-02-24 swelling Pfizer COVID-19 vaccination.
53 2021-02-25 lymph node swelling suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); suffering from a... Read more
suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); Headache; Chills; Nausea; swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1686), via an unspecified route of administration on the arm/deltoid, on 07Jan2021, at single dose, for covid-19 immunization. Medical history included suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP). The patient had questions about some side effects from the COVID vaccine. She stated she received the first dose on 07Jan2021. About a week after that or maybe 7 to 9 days after the first shot, she started having side effects and was given a handout of a different side effects and risk of the vaccine and; she had like 4 or 5 of the side effects on Jan2021 such as headache, chills, nausea and swollen lymph node. She started with the headache initially then the chills, and nausea, and then lymph node. Her lymph nodes were still swollen. She informed was due to get the "booster" vaccine this Thursday (28Jan2021) and she just wanted to call and see if she should still go and get the booster vaccine with the swollen lymph nodes. She added she did get a test for the COVID this past Thursday (21Jan2021), because of the symptoms, and it was negative. She had the test because she didn't know if it was the vaccine side effect because the side effect also fell in line with actual COVID symptoms. She wanted to make sure that she didn't have the virus. At the time of the report she had not recovered from the adverse events headache, chills, nausea and swollen lymph node and she did not receive any treatment for these. The outcome of the other remaining events was unknown.
53 2021-02-26 lymph node swelling, lymph node pain Lymph nodes swollen and sore
53 2021-02-26 lymph node swelling Severe fatigue, muscle pain, headaches, swollen cervical and axillary nodes for over 1 month. From ... Read more
Severe fatigue, muscle pain, headaches, swollen cervical and axillary nodes for over 1 month. From about 1/18/21 until now.Swelling in lymph nodes has subsided some in the last week and the fatigue has also subsided some. I saw my primary Dr, on 2/17/21 for a routine check up and he did note my lymph nodes were all swollen. I told him my symptoms and he stated I could be having an immune response to the COVID vaccine. I had none of the above symptoms before receiving the COVID vaccines.
53 2021-02-28 swelling Angioedema, team; recommended 60 minute evaluation . No further intervention Diagnosed with acute... Read more
Angioedema, team; recommended 60 minute evaluation . No further intervention Diagnosed with acute allergic reaction without anaphylaxis. 1120 135/85 24 RR 69 HR 100% O2 Sat. 1130 98% O2 Sat, 20 RR, 71 HR. 1140 98% 68 HR 20 RR. Discharged at 1140. Patient stable.
53 2021-02-28 lymph node swelling, oral herpes Large cold sore/lesion on top left lip - open - treated at home with abreva/hydrogen peroxide. Pain ... Read more
Large cold sore/lesion on top left lip - open - treated at home with abreva/hydrogen peroxide. Pain from top of lip to left eye, pain bottom lip, gland swollen under left side of mouth. Lips became very dry. Has not totally gone away, still treating at home no pain from lip to eye or mouth anymore gland not swollen. However intense pain lasted four days.
53 2021-02-28 swelling face Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers in... Read more
Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, unknown expiration), via an unspecified route of administration in right arm on 19Jan2021 at a single dose for COVID-19 immunization in a workplace clinic. Medical history included hypothyroidism, idiopathic thrombocytopenic purpura (ITP), and previously administered dermal fillers in Jun2020. The patient has no allergies to medications, food, or other products. Concomitant medications included levothyroxine, tamoxifen, and vitamin D. The patient also received her first dose of BNT162B2 (lot number: EJ1685, unknown expiration) for COVID-19 immunization in right arm on 29Dec2020. The patient experienced swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness on 21Jan2021. The patient received steroids and antihistamines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient recovered from the events on unspecified date. The events were assessed as non-serious. No follow-up attempts are possible. No further information is expected.
53 2021-02-28 swelling, swelling face Lost 100% of vision in left eye and 50% of vision in right eye; Numbness of face and neck; Numbness ... Read more
Lost 100% of vision in left eye and 50% of vision in right eye; Numbness of face and neck; Numbness of face and neck; Swelling of face and neck; Swelling of face and neck; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech, lot number EN6201), via an unspecified route of administration in right arm, on 10Feb2021 at 15:45, at single dose, for COVID-19 immunisation. Medical history included blood cholesterol increased. Patient did not have known allergies, did not have COVID-19 prior to vaccination and was not pregnant at time of events or vaccination. There were no concomitant medications. Patient did not receive other different vaccines in four weeks. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech, lot# EL3244), in arm left, on 20Jan2021 at 15:45, for COVID-19 immunisation. The patient experienced lost 100% of vision in left eye and 50% of vision in right eye on 10Feb2021 at 17:30 with outcome of recovered on 11Feb2021 at 07:30 (after 14 hours), numbness of face and neck on 10Feb2021 at 17:30 with outcome of recovered on 12Feb2021 at 09:30 (after 40 hours), swelling of face and neck on 10Feb2021 at 17:30 with outcome of recovered on 12Feb2021 at 09:30 (after 40 hours). Patient did not tested positive for COVID-19 after vaccination. No follow-up attempts are possible. No further information is expected.
53 2021-03-01 lymph node pain tingling above lip on Sunday, went into left cheek, tightness in eye muscle, lymph node pain, lt-hea... Read more
tingling above lip on Sunday, went into left cheek, tightness in eye muscle, lymph node pain, lt-headache in occipital bone -2/26 went to hospital, paralyzed in left side of face, bells palsy
53 2021-03-01 lymph node swelling LYMPHADENOPATHY (LYMPH NODE SWELLING IN THE AREA BETWEEN THE NECKA ND THE COLLARBONE ON THE SIDE OF ... Read more
LYMPHADENOPATHY (LYMPH NODE SWELLING IN THE AREA BETWEEN THE NECKA ND THE COLLARBONE ON THE SIDE OF INJECTION
53 2021-03-02 swelling Hives, bumps in the whole body, red and warm skin, itchy and swelling
53 2021-03-03 swelling Cannot determine if last digit is a U or J. 10 days post injection acute onset of pinched nerve i... Read more
Cannot determine if last digit is a U or J. 10 days post injection acute onset of pinched nerve in lower neck/ upper back where left arm connects. Numbness/weakness in left arm and pain upon lifting arms above shoulders. Either side but significantly worse on left side. Limited mobility to move neck and head without pain unless medicated. Muscle spasms left of spine in upper back/neck and tingling down left arm. Severe pinched nerve pain that got progressively worse from onset.
53 2021-03-04 lymph node swelling Swelling in lymph nodes on left side of body. Armpit area. Painful.
53 2021-03-04 lymph node swelling I had a swollen lymph node on left arm lasting 5 days.
53 2021-03-08 lymph node swelling Extreme swollen lymph nodes in my armpit
53 2021-03-08 peripheral swelling Very mild abdominal tightness within the first 15 min, no big deal and I did not report. About 4 hou... Read more
Very mild abdominal tightness within the first 15 min, no big deal and I did not report. About 4 hours later notice marked abdominal/gut tightness and bloating. Very fatigued. Swelling in extremities and moderate joint pain. Increased thirst. Next morning had sharp pleuritic type of chest pain increased with inspiration lasting about 20 min. Moderate/severe fatigue. Abd tightness, bloating, and fatigue continued for the next 48 hours and persisted but is milder today on 3/9. Continued fatigue. And the expected headache.
53 2021-03-09 lymph node swelling The next day, the lymph node on the left side on my underarm was swollen/enlarged. I felt feverish. ... Read more
The next day, the lymph node on the left side on my underarm was swollen/enlarged. I felt feverish. I went to the Dr and she ordered an ultrasound and an mammogram but I didn't get it because I heard on news that they advised to wait until the swelling had a chance to go down before getting an ultrasound and mammogram. The swelling went down after a week. It was so swollen I couldn't put my arm down. I will get my tests done for six weeks.
53 2021-03-09 swelling face Throat felt scratchy gave 50mg/mL IM benadryl. Face swelled up and turned red and her chest hurt. ... Read more
Throat felt scratchy gave 50mg/mL IM benadryl. Face swelled up and turned red and her chest hurt. Gave 0.3mg epipen vastus lateralis. Brought patient to ER via wheelchair
53 2021-03-10 swollen extremities injection pain, nausea, dizziness, headache immediately following injection pain, swelling in undera... Read more
injection pain, nausea, dizziness, headache immediately following injection pain, swelling in underarm 2 days following injection Continues to be problematic
53 2021-03-10 peripheral swelling pain and swelling in underarm area of same arm where received vaccination. This started approximatel... Read more
pain and swelling in underarm area of same arm where received vaccination. This started approximately 36 hours after vaccination. Has continued for more than 24 hours. Still swollen and sore at this time. Injection site is also still sore, but not severe, and no swelling or redness at the injection site.
53 2021-03-14 peripheral swelling I received the 1st vaccine on March 4th. Only had a sore arm. Then on March 10th I woke up before 2:... Read more
I received the 1st vaccine on March 4th. Only had a sore arm. Then on March 10th I woke up before 2:00 that morning itching all over. At 6:30 am I was covered in painful rash from behind my knees to my shoulders. It itches and hurts. I went to immediate care at which time they gave me a steroid shot, antihistamine tablets and a cream. Today it got so painful I went back to immediate care and was given a shot of epinephrine and given an epipen. The rash is raised and deep red. Very itchy and painful. It is now on my hands as well and they are stiff and swollen. Both doctors that I seen suggested going to regular physician before taking second dose of vaccine
53 2021-03-15 swelling Within 30 minutes of vaccine entire left side had numbness and tingling from left toes to left eye w... Read more
Within 30 minutes of vaccine entire left side had numbness and tingling from left toes to left eye with radiating pain in head and swelling of neck and throat. Numbness subsided within 24 hours followed by pain and sensitivities on entire left side for the next 24 hours. Swelling in throat continued for the next 24 hours following vaccine peaking the next day 36 hours after vaccine. Significant trouble swallowing liquids including salvia. Choking on solid foods the day following vaccine. Lips tingling continued for 48 hours after vaccine and subsided at end second day 3/12. Throat and esophagus swelling continues to this day - 6 days after vaccine with only slight improvement in swelling. Swallowing is still difficult as of 6 days following 1st vaccine. Spoke with EMT at vaccine site who recommended Benadryl. Benadryl started within 1.5 hours of vaccine administration. Contacted allergist who recommended 2-3 x dose of antihistamines for swelling. A dose of 3x was done for 4 days and decreased to 2x dose of antihistamines on Monday and continue at that level at time of report today.
53 2021-03-17 lymph node swelling neuropathy in left foot; HEADACHES/INTERMITTENT HEADACHES; NAUSEA; MUSCLE ACHES; BILATERAL LOWER ARM... Read more
neuropathy in left foot; HEADACHES/INTERMITTENT HEADACHES; NAUSEA; MUSCLE ACHES; BILATERAL LOWER ARM PAIN AND JOINTS/PAIN PROGRESSING TO CONSTANT SEVERE PAIN AND HAS MOVED INTO UPPER ARMS WITH PAIN WORSENING DAILY; BILATERAL LOWER ARM PAIN AND JOINTS; SWOLLEN LYMPH NODES IN ELBOWS; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284, expiration date: not reported) intramuscular in the arm left on 01Feb2021 08:00 at single dose for COVID-19 immunisation. Patient medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); and lamotrigine (LAMICTAL). The patient previously took codeine and experienced allergic reaction to drug; naproxen and sulfur and experienced drug allergy. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at the hospital. On 02Feb2021 06:00, the patient experienced neuropathy in left foot, headaches/intermittent headaches, nausea, muscle aches, bilateral lower arm pain and joints, swollen lymph nodes in elbows, pain progressing to constant severe pain and has moved into upper arms with pain worsening daily. No treatment received for the adverse event. Outcome of the events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event neuropathy peripheral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
53 2021-03-17 swelling, swelling face My eyes, face and neck were very swollen. My eyes hurt really bad and my vision was blurry. Face a... Read more
My eyes, face and neck were very swollen. My eyes hurt really bad and my vision was blurry. Face and neck itchy.
53 2021-03-18 lymph node swelling received vaccine @930 am, 3:30 pm felt weak, mild pain behind my eyes, sniffles, slept for 40 minute... Read more
received vaccine @930 am, 3:30 pm felt weak, mild pain behind my eyes, sniffles, slept for 40 minutes. Symptoms increased and continued through out the night, childs and sweats , overall feeling of weakness. Mentally slow processing, feeling foggy. Symptoms Cleared on Monday evening around 9pm. New symptoms on March 19th swollen glands roof of my mouth, neck, underarms. Painful, brain fog, exhaustion, chills and sweats, stuffy nose, headache.
53 2021-03-18 swelling On the night of the 15th when i received the vaccine my arm was sore and i was very tired. I woke up... Read more
On the night of the 15th when i received the vaccine my arm was sore and i was very tired. I woke up next day after a great sleep and arm was just a little sore but I was totally exhausted and napped through the day and went to sleep that night. Wednesday the 17th of march I woke up at 4:30 in morning with a screaming headache and my neck and shoulder muscles were extremely tight. I felt like my head was going to explode! I am not used to headaches but this one hurt pretty bad. I took Tylenol and used ice packs on head and neck and back shoulders. I used Electronic Muscle Stimulator Pads for 12 minutes on middle shoulder back area. That evening I was feeling a little better with small headache but when i was rubbing
53 2021-03-18 swelling Sore throat with coughing and swelling, fever chills muscle aches, headache
53 2021-03-21 lymph node swelling, swelling Lump, redness, and heat in injection site on the day after the second shot. The second day after t... Read more
Lump, redness, and heat in injection site on the day after the second shot. The second day after the shot developed swelling in the neck on left side between neck and shoulder area. Third day lymph node swelling and pain when swallowing. Arm still red, swollen and hot on third day after the shot. I have iced down both area which has not helped. I contacted occupational health as I work at a hospital and received the vaccine there. I was told to contact my PCP, which I did and am waiting to hear back.
53 2021-03-21 lymph node swelling FEVER, ACHES, SORE THROAT, SWOLLEN GLANDS, HEADACHE, STIFF NECK...SO FAR GOING ON TWO DAYS
53 2021-03-21 swelling face, lymph node swelling swollen lymph nodes; facial swelling; This is a spontaneous report from a contactable consumer (pati... Read more
swollen lymph nodes; facial swelling; This is a spontaneous report from a contactable consumer (patient). This 53-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 18Feb2021 at 14:00 (at the age of 53-years-old) as a single dose in the right arm for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine, the patient was no diagnosed with COVID-19. Concomitant medications included cetirizine (ZYRTEC) from an unspecified date for an unspecified indication. The patient previously received naproxen from an unspecified date for an unspecified indication and experienced allergy. The patient also had allergies to beeswax, honey, chemical aerosol sprays, and perfumes. On 18Feb2021 at 16:45, approximately three hours after the vaccine, the patient experienced facial swelling and swollen lymph nodes. The events were reported as non-serious. The patient went to the emergency room/department of urgent care as a result of the event and received treatment with high dose diphenhydramine (BENADRYL). The outcome of facial swelling and swollen lymph nodes was recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
53 2021-03-21 swelling face Transient face swelling, right eye dryness, cluster headaches since 03/05/21. Bells palsy symptoms ... Read more
Transient face swelling, right eye dryness, cluster headaches since 03/05/21. Bells palsy symptoms right side of face since 03/07/21. Swelling is transient symptom. Cluster headaches are transient symptoms. Bells palsy symptoms have not resolved. Treatment from PCP is steroid prescription started 03/20/21.
53 2021-03-22 peripheral swelling Left leg started hurting, and swoll up from my knee to my foot, and the next day was told to go to h... Read more
Left leg started hurting, and swoll up from my knee to my foot, and the next day was told to go to hospital. They found a blood clot in my leg .
53 2021-03-23 lymph node swelling lymph node under arm left arm swollen, left side gums imflamed and left eye eyelid imflamed.
53 2021-03-24 swelling Post COVID Vaccine injection 1639 numbness left lips, tingling in throat and feels tight BP 148/86 ... Read more
Post COVID Vaccine injection 1639 numbness left lips, tingling in throat and feels tight BP 148/86 - HR 75 1643 Epi 0.3 via pen Right thigh Feeling shaking Medical emergency called 1645 Benadryl IM right arm. Feeling flushed ED clinical staff here and transferred in own electric wh/chair. Husband with patient Allergy to CT Contrast - completely swollen shut
53 2021-03-25 lymph node swelling Body aches, fatigue, nausea, headache, lymph node above collarbone swollen.
53 2021-03-25 peripheral swelling Patient states her feet started swelling instantly and she felt nauseated and also felt warm. When ... Read more
Patient states her feet started swelling instantly and she felt nauseated and also felt warm. When her vitals were taken everything was normal. She asked to be transported to have further observation.
53 2021-03-26 axillary mass, lymph node swelling Pain, swelling, lump in left armpit lymph node. Muscle pain and discomfort in body. Pain in left ar... Read more
Pain, swelling, lump in left armpit lymph node. Muscle pain and discomfort in body. Pain in left arm at vaccine location.
53 2021-03-26 lymph node swelling, lymph node pain Swollen and painful lymph node on left collarbone, plus tender-to-the-touch nodes in left armpit. I... Read more
Swollen and painful lymph node on left collarbone, plus tender-to-the-touch nodes in left armpit. I consider this minor compared to contracting COVID-19
53 2021-03-28 lymph node swelling Hives to chest and arms, Swollen left neck lymph node, diarrhea, injection site warm
53 2021-03-28 swelling face One week after 1st vaccine, woke up with 3 blisters on inside of upper lip. No other side affects. ... Read more
One week after 1st vaccine, woke up with 3 blisters on inside of upper lip. No other side affects. After 2nd shot, I did have a slight headache, but not any different than the headache I get with seasonal allergies. No medicines required. Then 51 hours after the 2nd shot, I started having swelling on left side of the face (cheek area). Took Benadryl and iced it, swelling subsided slightly. Approximately 6 hours later, swelling return and is not more swollen than before. Taking additional Benadryl and Zyrtec and following up with an ENT doctor in AM if symptoms do no subside.
53 2021-03-30 lymph node swelling swelling to left underarm lymph node; pain at site; left arm "ache" with decrease in strength; This ... Read more
swelling to left underarm lymph node; pain at site; left arm "ache" with decrease in strength; This is a spontaneous report from a contactable other hcp. A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: El3249, expiration date: not reported) via an unspecified route of administration, administered in Arm Left on 27Jan2021(at the age of 53 years) as single dose for COVID-19 immunization. Medical history included hypothyroidism , migraine and rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included thyroid taken for an unspecified indication, start and stop date were not reported. The patient also took BCP in two weeks. The patient previously took cipro and experienced drug hypersensitivity, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Ek9231, expiration date: not reported) via intramuscular route of administration, administered in Arm Left at 09:15 on 06Jan2021 as single dose for COVID-19 immunization and experienced malaise. The patient experienced swelling to left underarm lymph node, pain at site and left arm "ache" with decrease in strength on 28Jan2021. The outcome of events was recovering.
53 2021-03-30 swelling face Pfizer-BioNTech Covid-19 Vaccine Swelling of face, lips and throat / Numbness
53 2021-03-31 lymph node swelling Soreness in arm and muscle aches lasting several days. Hot flashes lasted 3-4 days. Headache and f... Read more
Soreness in arm and muscle aches lasting several days. Hot flashes lasted 3-4 days. Headache and fatigue still lasting one week later. Swollen lymph nodes in neck and mild sore throat noticed approximately 5 days after and still lasting one week after shot.
53 2021-04-01 lymph node pain, lymph node swelling Site soreness, headache, within 5 hours, Fever (100.7), muscle pain, aches, chills, sweating at 16 ... Read more
Site soreness, headache, within 5 hours, Fever (100.7), muscle pain, aches, chills, sweating at 16 hours after vaccine and lasting through the next 24-36 hours. After this time large, swollen, very tender lymph nodes u under left armpit (same as injection) and slight tenderness under right armpit. This lasted another 2 days. Muscle pain in my lower back was the most intolerable of the symptoms as this continued well after my fever broke.
53 2021-04-01 lymph node swelling extreme neck stiffness, soreness on complete neck - all the way around and inflamed glands - hurts t... Read more
extreme neck stiffness, soreness on complete neck - all the way around and inflamed glands - hurts to turn or tilt head - sore to touch and affecting swallowing and voice - raspiness and cracking - dryness of throat
53 2021-04-01 peripheral swelling My left are is still swollen and is a little tender to touch. There is a big lump on my upper arm.
53 2021-04-01 swelling face Numbness on the roof of my mouth, near my throat. Hot flashes, sweating, high blood pressure, the fe... Read more
Numbness on the roof of my mouth, near my throat. Hot flashes, sweating, high blood pressure, the feeling of passing out, super hot throughout my body. Numbness in left cheek and upper lip. Swelling in left cheek and left eye. Dizzy.
53 2021-04-02 lymph node swelling Whole arm aches today. Injection site warm to touch and armpit lymph node very swollen
53 2021-04-02 peripheral swelling Itching on the right fifth finger, and slightly swollen. SBP 154 (pulse 95), 96% O2 sat. Final BP 15... Read more
Itching on the right fifth finger, and slightly swollen. SBP 154 (pulse 95), 96% O2 sat. Final BP 152/93 (pulse 91), O2 sat 97%.
53 2021-04-02 swelling face PUFFY/SWOLLEN AND IRRITATED EYES; SWOLLEN FACE; SNEEZING, CONGESTION, DIZZY, LETHARGY TINITUS.
53 2021-04-03 lymph node swelling Swollen lymph nodes on left side of neck and in left armpit area. Tender to the touch. General ache... Read more
Swollen lymph nodes on left side of neck and in left armpit area. Tender to the touch. General aches and injection site soreness. All symptoms are on the left side, the same side of the injection site. Started around 4 pm on Friday 4/2/2021. I took 500mg of Tylenol on Friday at 8pm, and at 2am on Saturday 2/3/2021.
53 2021-04-03 lymph node swelling swollen lymph node in vaccinated arm
53 2021-04-04 lymph node swelling Swollen lymph nodes- left underarm area and left groin area
53 2021-04-06 anaphylactic reaction This is a spontaneous report received from a contactable Consumer, the patient. A 53-years-old non-p... Read more
This is a spontaneous report received from a contactable Consumer, the patient. A 53-years-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, lot number, expiration date: not available) via an unspecified route of administration on left arm on 24Mar2021 09:15 at single dose for COVID-19 immunisation. The patient's medical history included Gastroparesis, allergies to medications, food, or other products: latex, yeast, wheat, guafanisen and Dextromethorphan. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 09:15 AM, patient experienced anaphylaxis within minutes of having the injection and began to feel flushing down throat, then down to chest. That was concerning but when suddenly, patient got really hot, ripped her mask off, and she realized that she was having difficulty breathing and it got worse as time went on, it was resulted in Emergency room/department or urgent care. Patient received Epi-pen, Benedryl, fluids as the treatment for the events. The outcome for the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
53 2021-04-06 lymph node swelling Woken up in the middle of the night with a pounding fast heart beat aprox 14 hers after injection. ... Read more
Woken up in the middle of the night with a pounding fast heart beat aprox 14 hers after injection. Other symptoms that were not as serious for the next day were a left side armpit lymph node with swelling and pain, soreness at injection site, chills, head swimming, eye puss , and intermittent nausea.
53 2021-04-06 peripheral swelling, lymph node swelling Afternoon of second vaccine- malaise and sore arm. 1/15- body aches, malaise, sore arm, swelling of ... Read more
Afternoon of second vaccine- malaise and sore arm. 1/15- body aches, malaise, sore arm, swelling of arm and tingling in hand that lasted 3 weeks. Red injection site with hard 3 inch diameter at the injection site. 1/15- chills and sweating, but no increased temperature 1/16-18- malaise, body aches, swollen lymph nodes in right axilla.
53 2021-04-07 swelling, swelling face, swelling Tuesday 6 go the first Pfizer Covid vaccine at the race track. In the past I have had angioedema and... Read more
Tuesday 6 go the first Pfizer Covid vaccine at the race track. In the past I have had angioedema and breathing issues but never severe enough to warrant going to hospital with several injections and from over the counter meds and prescription meds. So I was wary but decided to risk a jab. Straight up got tingling tongue and lips but after 15 min was just dizzy and roughly the same feeling. I am a slow up taker and excreter though. By the time I got home, about 20 min after the 15 min wait my neck on the injection side and swelled so much I no longer had a jaw and my eyes and cheeks were pretty puffy. Then the breathing issue started. I called the gp who said Tylenol, benedryl. Usually have them made because I have problems with additives but i don?t have any right now. So I used two ea kids chewable which allow me to have a dosage that works for me as I am sensitive to larger doses which can cause pvcs. Things were better but not good enough so took Zyrtec 10 ml/24 hr. If I had not had a similar experience with other injections this would have completely freaked me out. Thank goodness my quick treatment worked well enough that I felt confident worse was unlikely to happen, though the gp and allergist both wanted me to go to the er. Yesterday I did a repeat of Tylenol and benedryl in the morning and Zyrtec in the afternoon at two pm then Tylenol and benedryl again in the evening as I still had angioedema and felt tight in breathing. Repeat benedryl and Tylenol today but no Zyrtec as felt good enough to ride stationary bike a very slow Five miles. As to fever and other typical symptoms it has been hard to tell what is reaction and what is simply the vaccine doing its job. I did not take my temperature but have felt hot no general malaise. I recognize my symptoms are unusual but felt you should have them.
53 2021-04-07 bursitis Bursitis, right shoulder
53 2021-04-09 lymph node swelling 12 hours after vaccine, started with headache and dizziness, pain in knee , the tooth pain and jaw p... Read more
12 hours after vaccine, started with headache and dizziness, pain in knee , the tooth pain and jaw pain. few hours later sharp pain in bones, fever and chills added around 18 hours post vaccine, around 20 hours after vaccine I had a pulse of 118 feeling palpitation, flue like muscle achiness and weakness hit at night. I took Tylenol for it. the next day the lymph node in my arm pit same side vaccination (left) was swollen painful , and tender to touch. 2 days later I had runny nose with headaches.
53 2021-04-12 lymph node swelling, lymph node pain swollen lymph nodes under the left armpit and into the left breast area, radiating pain and discomfo... Read more
swollen lymph nodes under the left armpit and into the left breast area, radiating pain and discomfort that has persisted since onset, some numbness in the left arm.
53 2021-04-13 lymph node pain, lymph node swelling Swollen and tender right cervical lymph nodes - vaccine given in right deltoid.
53 2021-04-13 lymph node swelling Dizziness, severe HA, chest pain, back pain, swollen lymph nodes, stomach ache, metallic taste in mo... Read more
Dizziness, severe HA, chest pain, back pain, swollen lymph nodes, stomach ache, metallic taste in mouth. Fatigue
53 2021-04-13 neck mass, lymph node swelling After the first dose: I noticed a lump in the base of the neck and 2 other lumps around the neck. A... Read more
After the first dose: I noticed a lump in the base of the neck and 2 other lumps around the neck. Another lump behind my right hear. A few days later I had another big lump in the right side of my groin. I did not associate that with the vaccine and later I took the second dose of the vaccine. After the second dose I realized that I have more lumps around my neck and there were other ones developing under my chin and on the left side of my groin but a little bit smaller than the one on my right side which had become bigger and more painful.
53 2021-04-13 swelling face Face swelling within an hour of vaccination. Following day: itching, rash and sore throat (described... Read more
Face swelling within an hour of vaccination. Following day: itching, rash and sore throat (described as raw), cough Pt self-treated with diphenhydramine
53 2021-04-14 lymph node pain Fever, sore left underarm into chest area ( lymph nodes? ), headache, very tired ( napped all day t... Read more
Fever, sore left underarm into chest area ( lymph nodes? ), headache, very tired ( napped all day today morning into evening ). Tylenol helped
53 2021-04-14 lymph node swelling, lymph node pain Swollen and painful lymph node under right arm (in armpit area) noticed the day after the 2nd vaccin... Read more
Swollen and painful lymph node under right arm (in armpit area) noticed the day after the 2nd vaccine. Lymph node is still swollen and painful on day 3 after 2nd vaccine. Swollen and painful mass (I'm assuming it's a lymph node), in right clavicle area noticed on day 3 after 2nd vaccine. Swelling has increased slightly as the day continues.
53 2021-04-14 peripheral swelling Painful numbing, tingling and swelling in hands. Chest discomfort and shortness of breath. Swelli... Read more
Painful numbing, tingling and swelling in hands. Chest discomfort and shortness of breath. Swelling and breathing issues resolved within a few days. Numbing, tingling and pain in hands is slightly improved but ongoing.
53 2021-04-15 lymph node swelling Area in left armpit started to feel sore about 24 hours after the vaccination. Armpit area swollen, ... Read more
Area in left armpit started to feel sore about 24 hours after the vaccination. Armpit area swollen, and tender to the touch morning of April 16, 2021. Tenderness has extended out of the armpit area and up towards collarbone as has swelling. Afternoon of April 16, 2021. Onset of migraine like headache around 1 PM on April 16, 2021. Headache feels worse when sitting down..
53 2021-04-15 peripheral swelling Systemic: Body Aches Generalized-Severe, Systemic: cough, hand swelling & stiffness, hands warm to t... Read more
Systemic: Body Aches Generalized-Severe, Systemic: cough, hand swelling & stiffness, hands warm to the touch-Severe, Systemic: Joint Pain-Severe, Additional Details: Pt already has diagnosed autoimmune disorders and vaccine aggrevated & enhanced her symtpoms and she had to go to her Doctor and they prescribed her a Prednisone dose pack to reduce hand swelling, stiffness, and achiness. She also had to use her rescue inhalers and oxygen more often because it aggrevated her lungs.
53 2021-04-15 swelling face Reports face/neck rash beginning 2 days after 2nd Pfizer vaccine, different from her psoriasis rash.... Read more
Reports face/neck rash beginning 2 days after 2nd Pfizer vaccine, different from her psoriasis rash. She felt very itchy, with redness of head/neck area with swelling of face and eyes; worst day was 7 days after the 2nd shot. Saw her rheumatologist 2-3 days after shot and received a steroid shot, Pred-pak and is using topical calamine lotion. States rash is improving but still present. Face is now "splotchy" and eyes only swollen in AM.
53 2021-04-15 swelling Pt rcvd vaccine about 0855 and was being monitored for a minimum of 30 minutes per protocol. Pt with... Read more
Pt rcvd vaccine about 0855 and was being monitored for a minimum of 30 minutes per protocol. Pt without complaints initially while in 30 minute monitoring area. At approximately 0950 pt c/o feeling lips/eyes were swelling. Pt taken to tent w/ c/o HA. Volunteer MD assisted with monitoring: VS 165/96 HR 78 reg rate/rhythm, O2 sat 98 % on RA, lungs clear, skin warm slight diaphoresis noted. Supine on cot, cold compress provided, ice pack provided/to neck as requested. C/o lips eye are, face feeling swollen, c/o continued HA. Lip/facial swelling not visibly noted. Continued monitoring w/ VS 150/96, HR 74, sats 98% resp regular & lungs clear. Pt reported BP usually 120-125/70 and states she reacts to "a lot of things". Desired Benadryl, Volunteer MD gave pt 50 mg Benadryl. Pt desired sister to be called. Pt continued to c/o HA. BP 160/97 and pt reports taking her BP medications in am as prescribed. EMS called at 0955, EMS arrived, pt transported to ED per her request at 1010 for further monitoring. Reported by nurse, lead Monitoring RN.
53 2021-04-16 lymph node swelling 21 hours after 2nd shot developed tenderness, swelling and pain left armpit area possible interpecti... Read more
21 hours after 2nd shot developed tenderness, swelling and pain left armpit area possible interpectional nodes. Also experiencing nausea.
53 2021-04-16 lymph node swelling Swollen lymph node under the armpit of the right arm
53 2021-04-16 swelling face 40 minutes after receiving the vaccine I experienced hives, tachycardia, facial and throat swelling.... Read more
40 minutes after receiving the vaccine I experienced hives, tachycardia, facial and throat swelling. Treated onsite at the vaccination event with benedryl, taken to emergency room via ambulance and received an IV of Pepcid.
53 2021-04-17 lymph node swelling, swelling Lymph nodes began swelling 3 days after shot on left side of neck. The same side that shot was given... Read more
Lymph nodes began swelling 3 days after shot on left side of neck. The same side that shot was given. The swelling began in my neck along the collar bone. At first it felt like little knots, but by the end of the day the swelling had increased encompassing the entire area between my neck and shoulder as well as along the collarbone. I called my doctor who recommended warm compresses and tylenol as needed. I used warm compresses and essential oils to reduce the swelling. There was some immediate relief with the compresses and oils. Within 24 hours the larger area was no longer significantly swollen and continued to reduce over the next few days. However there are still knots and swelling present in my lymph nodes running along the collarbone on day 18 since the shot..
53 2021-04-17 lymph node swelling High blood pressure: 134 Sys, 119 Dia, 86 Pulse; Tachycardia; Headache; Severe dizziness; Difficulty... Read more
High blood pressure: 134 Sys, 119 Dia, 86 Pulse; Tachycardia; Headache; Severe dizziness; Difficulty talking and being able to express oneself; Fever; Muscular pain; Allergy and redness to left arm and chest; Swollen glands
53 2021-04-18 peripheral swelling after the first shot I had some severe headache, muscle ache, fatigue, injection site pain, sleepy, ... Read more
after the first shot I had some severe headache, muscle ache, fatigue, injection site pain, sleepy, and a little chills for a couple of days. But at the time of taking second shot the injection was very painful, after the second shot I had very bad headache, chills, real drowsy, muscle ache, fatigue, sleepy feeling, vomiting feeling for 3 days and also after about 20 hours of injection, on my right leg startedto have rashand itching . Itried to drink a lot of water, but evvery day it got worse and worse and after 6 days my whole right leg and part of my left leg was badly andseverwlt swelled up and my leg was filled up with my body fluid and was veryyy blacked and violet, and was itching crazily. I was rushed to the ER and received the treatment and it was recognized as the adverse and severe reaction and allergy to the stupid PFIZER COVID-19 VACCINE.
53 2021-04-19 lymph node pain 25 hours after shot became very tired, injection site sore, lymph node soreness. 40 hours after extr... Read more
25 hours after shot became very tired, injection site sore, lymph node soreness. 40 hours after extreme tiredness despite full night of sleep, intense pain in lymph node, unable to stand for more than a few minutes. Tuesday 8am symptoms have eased but remain. Lymph node swelling is notable. Still lethargic.
53 2021-04-20 anaphylactic reaction Patient reported itchiness and tingling in throat and lower extremities as well as hoarseness of voi... Read more
Patient reported itchiness and tingling in throat and lower extremities as well as hoarseness of voice. Reports that when she had an anaphylaxis reaction to shellfish it started the same way and progressed to occluded airway. Vitals were within normal limits and 911 was called for transport Hospital ED. Symptoms reported around 11:05, EMS arrived around 11:30 and patient transported around 11:40.
53 2021-04-21 lymph node swelling headache, joint pain, chills, swollen lymph gland (right armpit), low grade fever, fatigue, insomnia
53 2021-04-21 lymph node swelling Low grade fever and flushing to face and upper neck beginning around 5:30pm on Tuesday 20th of April... Read more
Low grade fever and flushing to face and upper neck beginning around 5:30pm on Tuesday 20th of April. 2 Ibuprofen taken orally. Temperature was normal when checked 45 minutes after taking ibuprofen. Pain, tenderness, and swelling of lymph node in Right armpit noticed approximately an hour after low grade fever. Lymph node became warm, quite swollen and painful with what seemed to be excess fluid around it. 2 Ibuprofen were taken at 11:30pm, no reducing in symptoms detected. Lymph node was still very swollen and painful the next morning so a warm compress was applied which provided a small amount of comfort but did not reduce swelling. By 11am on the 21st lymph node was so painful that I took 500mg Naproxen. Swelling of the lymph node reduced approximately an hour to hour and a half after taking Naproxen, but swelling was not entirely eliminated. Swelling of lymph node continues as of today, Thursday. Injection site pain, feeling 'bruised' as well as red and hard approx. size of nickel.
53 2021-04-22 swelling face 53-year-old female patient presents emergency department with complaint of left-sided facial numbnes... Read more
53-year-old female patient presents emergency department with complaint of left-sided facial numbness and left arm numbness. Patient states that around bedtime last night at 2100 patient was watching television with her husband when she developed a headache and noted some left blurred vision. She states she also developed left facial swelling with mild redness and some sore in her mouth. She woke up at 0600 this morning with new symptoms of left face and left arm numbness. She reports the facial swelling, redness, and sores, as well as left eye blurred vision have improved some. The symptoms have not interferred with her ADL or prevent her from functioning. She denies history of stroke, HTN, TIA. She reports that she received her second Pfizer COVID-19 vaccination on 2/9/21 and developed the above mentioned symptoms within about 24 hours. hief complaint numbness left side of her face, blurry vision on left eye, numbness left arm, blisters on hard palate after Covid vaccine administration-symptoms improving, still have some numbness left side of her face Muscle strength equal on the right and left, no mouth droop, normal speech Assessment and plan Acute left facial and left arm paresthesias Left eye blurry vision Headache Covid 19 vaccine administration 3 days ago Questionable TIA History of ocular migraine Palpitation Neurochecks MRI of the brain Check TSH, iron studies, B12, folic acid level, magnesium, echocardiogram MRI - normal CT angio - normal echo - normal symptoms rapidly improved after 1 day in the hospital other than some lingering mild blurry vision. pt was discharged after 1 night in the hospital
53 2021-04-24 anaphylactic reaction anaphylactic signs in throat; wheezing; This is a spontaneous report from a contactable consumer. Th... Read more
anaphylactic signs in throat; wheezing; This is a spontaneous report from a contactable consumer. This 53-year-old female consumer reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #EP7534) via an unspecified route of administration in right arm on 23Mar2021 01:30PM (at the age of 53-year-old) at single dose for COVID-19 immunisation. Relevant medical history included high blood pressure, seasonal asthma and allergies, depression, stomach ulcers and allergies to nuts and seafood. Concomitant medications included losartan, omeprazole (OMEPRAZOL), venlafaxine hydrochloride (EFFEXOR), ascorbic acid (VIT C), trazodone hydrochloride (TRAZODON) and cetirizine hydrochloride (ZYRTEC). On the evening of 23Mar2021 the patient had wheezing. On 24Mar2021 09:30AM she woke with rash on right side of face, followed by hives, then itchy head and neck, then in throat. When she got to rash stage, symptoms developed quickly, leading up to anaphylactic signs in throat. She called the doctor immediately (after taking Benadryl). The event resulted in doctor or other HCP office/clinic visit. Treatments included prednisone, Benadryl, famotidine, Zyrtec - 8 days. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Information on the lot/batch number has been requested.
53 2021-04-24 lymph node pain she began to feel like she was straining to take a deep breath. When she would take a deep breath (l... Read more
she began to feel like she was straining to take a deep breath. When she would take a deep breath (like a yawn), she would do her best to stifle it as her chest would experience an immense pain while inhaling deeply/diagnosed with pericarditis; fluid had accumulated around her heart; headache/migraine; patient's lymph nodes on neck were causing her discomfort; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 25Mar2021 10:45 (Batch/Lot Number: ER8730) as SINGLE DOSE for covid-19 immunization. Medical history included "Hypothyroid" (hypothyroidism) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took guaifenesin (MUCINEX) and experienced allergies. On 31Mar2021, the patient's lymph nodes on neck were causing her discomfort which continued throughout. Around 1:00 am on 03Apr2021, she began to have a very intense headache/migraine. She began a regimen of Tylenol (8/day) and Advil (6/day) to mitigate the pain. Although the pain would diminish when she took these over-the-counter medicines, the headache never went away. In the evening of Sunday, 04Apr2021, she began to feel like she was straining to take a deep breath. When she would take a deep breath (like a yawn), she would do her best to stifle it as her chest would experience an immense pain while inhaling deeply. On Monday, 05Apr2021, went to a Clinic as she was straining so hard to breath. After numerous tests, she was diagnosed with pericarditis and, because of this, fluid had accumulated around her heart which was drained in a procedure called pericardiocentesis. They initially drained 230 ml and then 74 additional ml from a drain they had placed. The patient was hospitalized due to the events. The patient underwent lab tests and procedures on 05Apr2021 which included Nasal Swab (sars-cov-2 test) with negative result. The outcome of events was reported as "recovering". The patient did not receive treatment for "patient's lymph nodes on neck were causing her discomfort" but received treatment for all of the other events. Follow-up attempts are completed. No further information is expected.
53 2021-04-24 lymph node swelling Soar arm that had the vaccine, horrible aches through the whole body, heavy chest and a swollen lym... Read more
Soar arm that had the vaccine, horrible aches through the whole body, heavy chest and a swollen lymphoid in the arm pit of the injection. Also fatigued.
53 2021-04-24 swelling Severe headaches; swelling; heavy dizziness; Heart palpitations; heavy body aches and pain; dry mout... Read more
Severe headaches; swelling; heavy dizziness; Heart palpitations; heavy body aches and pain; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 53-year-old female patient received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Formulation: Solution for injection, Lot number: Unknown, Expiry date: Unknown), via an unspecified route of administration in left arm on 10Apr2021 at 14:15 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included diabetes, high cholesterol. There were no known allergies. Concomitant medication included metformin 100 mg, atorvastatin 20 mg and lisinopril for unknown indication. The patient not had COVID prior vaccination. The patient had not taken any other vaccines four weeks prior vaccination. On 10Apr2021 at 14:30 (15-minutes after vaccination), patient experienced severe headaches, swelling, heavy dizziness, heart palpitations, heavy body aches and pain, dry mouth. The patient visited emergency room/ department or urgent care and was hospitalized for the events for one day on unspecified date. The patient was not tested for COVID post vaccination. Therapeutic measures taken as a result of events included intravenous drip, Prednisone. The outcome of all the events was recovering. Information about Lot/Batch number is requested.
53 2021-04-24 swelling Patient states right side of her neck is swollen and tender and has progressively extended up to her... Read more
Patient states right side of her neck is swollen and tender and has progressively extended up to her right ear. Patient is an employee so brought patient to Store Director and they discussed options for seeing a doctor, sick leave, etc.
53 2021-04-25 swelling face 6 hours after the second vaccine I experience typical symptoms of fever, fatigue and muscle aches. T... Read more
6 hours after the second vaccine I experience typical symptoms of fever, fatigue and muscle aches. Then 6 hours later I woke up with a swollen face, swollen eyes, welts, and hives. It burned and itched. I called the EMT and a doctor said I was not having an anaphylactic shock, but some sort of allergic reaction. He gave me a cortisone bill and proscribed an antihistamine. I took 50 mg. of cortisone for two days with 10mg. of an antihistamine. It subsided a bit, but at night, I swelled up again. Today I went to the doctor and got a cortisone infusion.
53 2021-04-25 swelling It felt immediate like my throat was closing up and mild itching but will going to the observation p... Read more
It felt immediate like my throat was closing up and mild itching but will going to the observation phase, it stopped. However, my shoulder was sore; by the next morning, it was a small knot under the skin. But most said that you could apply some alcohol to it; I did several times. But by Sunday, there was still swelling, and the bump is bigger. Thus I am going to call my primary physician to see what steps do I need to take.
53 2021-04-26 anaphylactic reaction This is a spontaneous report from a contactable consumer. A 53-year-old female patient received her... Read more
This is a spontaneous report from a contactable consumer. A 53-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 11Apr2021 09:15 (Lot Number: EP7533; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 53 years). Medical history included asthma, Blood pressure high, acid reflux , allergies: Sulfa, Lactose intolerant and allergies: Latex. The patient's concomitant medications were not reported. The patient had a historical vaccine of Flu shot (INFLUENZA) on an unspecified date for immunisation and experienced bad side effects. The patient previously took bactrim, minocycline, doxycycline, ciprofloxacin, Moxifloxacin, demerol, avelox, nitrofurantoin, naprosyn, motrin, perocet, tramadol and aleve and experienced allergies. The patient experienced anaphylaxis on 11Apr2021. It was also reported that she had an appointment for COVID Vaccine at 9:15AM. Received COVID Vaccine and was told to wait for 30 minutes. Within 10 minutes her chest starting getting tight with difficulty of breathing. Her throat was closing up, and she was light headed. She explained this to the administrator who asked if caller could get up to see the paramedic. As caller tried to stand up, she almost passed out. Had to sit there for a second and the second time was able to get up and made it in to the room. Was going in and out of consciousness. Had to stab her with an Epi Pen. She couldn't breathe. Her throat was closing up. Her tongue was swollen. She was in and out of consciousness. First Epi Pen didn't work. An IV was put in and was given something through it. She was jabbed with a second Epi Pen. Was still in and out of consciousness but she was starting to come back. Was given oxygen and a nebulizer. She does have asthma. Ambulance was called. Was told she was worked on for 20 minutes. When ambulance arrived she was able to get up and get on the cart. She was taken to the hospital. Was given medicine through her IV. Had to be kept at hospital because she had two Epi Pens and medication at the vaccine facility. Hospital wanted to make sure when the Epi Pens wore off she didn't go back into anaphylaxis. Was kept in ER for over four hours. Was given IV fluids. Her oxygen, heart rate, and blood pressure dropped at vaccination facility. Oxygen was 81. Blood pressure was 94. At hospital, her levels started to get better. Once she was given the second Epi Pen and whatever else she was given, the medication started to work and she had come through. At the hospital, someone came in and did bloodwork for research to see why this happened. Was prescribed Epi Pens by the doctor in the hospital and was advised to carry Epi Pens with her at all times. If she has another anaphylaxis, was advised to jab herself with Epi Pen and call right away. Was told her tongue was swelling. Attempted to obtain the outcome of the anaphylaxis. At the hospital, she was so out of breath walking to the bathroom. Was told at hospital now she is having side effects from the COVID Vaccine including the tiredness and headache she is experiences. Was told to take Tylenol and Benadryl, lay down and rest, and to make sure she drinks so she does not get dehydrated. Today, she feels nauseous, lightheaded and tired with a little headache. She feels better from yesterday. Is getting better and is having a little chills maybe an hour ago. She checked her temperature and does not have a temperature, but her insides feel warm . The patient was hospitalized for the event anaphylaxis on an unspecified date. Therapeutic measures were taken as a result of was going in and out of consciousness. Events for anaphylaxis, consciousness fluctuating, chest discomfort. dyspnea, throat tightness, presyncope and swollen tongue occurred on 11Apr2021 while the remaining events occurred on an unspecified date. The patient underwent lab tests and procedures which included blood pressure: dropped and 94, blood work: unknown results, heart rate: dropped, oxygen saturation: 81 and dropped on an unspecified date. Therapeutic measures were taken as a result of all the events. Outcome of the events was unknown.
53 2021-04-26 swelling Discomfort in left side of neck and shoulder; Swelling on left side of neck clavicle area and just b... Read more
Discomfort in left side of neck and shoulder; Swelling on left side of neck clavicle area and just below clavicle up above breast; dizziness; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP6955) via an unspecified route of administration on 27Mar2021 at 10:00 (at the age of 53-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included diabetes, gastroesophageal reflux disease (GERD), and high blood pressure. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included semaglutide (OZEMPIC), insulin degludec (TRESIBA), insulin lispro (HUMALOG), amlodipine, and loratadine from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EN6205) on 02Mar2021 at 10:00 as a single dose in the left arm for COVID-19 immunization. On 27Mar2021 at 10:30 (also reported as 15 minutes after the vaccine) the patient experienced swelling on the left side of the neck clavicle area and just below clavicle up above breast and discomfort in left side of neck and shoulder. The swelling began 15 minutes post vaccination and was accompanied by dizziness only when the neck was leaning to the left. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of swelling on the left side of the neck clavicle area and just below clavicle up above breast, discomfort in left side of neck and shoulder, and dizziness only when the neck was leaning to the left were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
53 2021-04-28 lymph node swelling, swelling face After shot 1, I had severe brain fog and a flare-up of my sarcoidosis with itching shins, fatigue, s... Read more
After shot 1, I had severe brain fog and a flare-up of my sarcoidosis with itching shins, fatigue, swollen lymph nodes. After shot 2, my system was initially fine. No reaction at all, in fact. But within 4 days, the sarcoidosis flare-up kicked in and has been building with nothing stopping it that normally works - rest being the big thing. I've slept 9-10 hours a night, plus naps as possible, and it has gotten progressively worse. Joints, lymph nodes in areas that aren't usually swollen joining the usual areas, facial swelling, itchy shins, and an incredible brain fog. I am beginning a course of prednisone today.
53 2021-04-29 lymph node swelling Sore arm, Exhaustion, heaviness, freezing couldn?t get warm, joint pain, achy, nerve pain, swollen ... Read more
Sore arm, Exhaustion, heaviness, freezing couldn?t get warm, joint pain, achy, nerve pain, swollen limp node in right armpit, diarrhea and upset stomach. Got Covid Arm(rash at the site of shot) 6 days after first dose.
53 2021-04-29 lymph node swelling L cervical lymphadenopathy
53 2021-04-29 peripheral swelling Swelling of Arm, pain under arm, knot at injection site w/redness,head / body ache and low grade fev... Read more
Swelling of Arm, pain under arm, knot at injection site w/redness,head / body ache and low grade fever/nausea.
53 2021-04-30 lymph node swelling swollen lymph nodes under her right arm; chills/Cold Chills; sore back/Back was hurting; sore arm/ar... Read more
swollen lymph nodes under her right arm; chills/Cold Chills; sore back/Back was hurting; sore arm/arm was sore and really hurting; This is a spontaneous report received from a contactable consumer(patient). A 53-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Formulation: solution for injection, Lot Number: EW0161, Expiry date: unknown), via an unspecified route of administration on 10Apr2021 at 09:00, as single dose for covid-19 immunisation. The patient medical history included first dose of bnt162b2 (Lot number: ER2613) received on 20Mar2021. On 20Mar2021, the patient Arm hurt bad, like really achy. The event recovered on 22Mar2021. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. Prior Vaccinations (within 4 weeks), Patient has had both doses of the Pfizer Covid Vaccine. On 11Apr2021, the patient experienced chills/cold chills, sore back/back was hurting, sore arm/arm was sore and really hurting, swollen lymph nodes under her right arm on 12Apr2021. She wanted to know if that was a side effect, what should she take, how long will that last, and is this normal. Caller clarifies that with the first one, her arm hurt bad, like achy. She never checked her lymph nodes then. The events were considered as non-serious. The outcome of the event was chills/cold chills reported as recovered on 12Apr2021 and other events were reported as recovering.
53 2021-04-30 peripheral swelling Client stated that during her 15-minute observation period, she experienced numbness and tingling in... Read more
Client stated that during her 15-minute observation period, she experienced numbness and tingling in her lips, which resolved within 4 minutes. She stated the sensation continued periodically for 2 days following the vaccine and lasted 3-4 minutes each time. She reported additional symptoms of headache for 2 days following first dose Pfizer COVID vaccine. 3 days following her first dose, her left middle finger became swollen, red, tingling and numb. She stated her left, middle finger issue resolved in 3 days.
53 2021-05-02 anaphylactic reaction Within 5-10 minutes, I started to cough. My elbows started to itch, then my face/ears. After 30 minu... Read more
Within 5-10 minutes, I started to cough. My elbows started to itch, then my face/ears. After 30 minutes, I told the head nurse that I was going to drive home as it didn't seem to be progressing further than a bit of cough and some very minimal itching. By the time I got to my car, it was a bit worse and I opted to just try to get home for a cold shower and Benadryl. After 10 minutes of driving, I turned around and went back to hospital with a full blown anaphylactic reaction -- throat closing, gasping for breath, unable to talk due to coughing. Nurse walked me through the hospital to the ER where I was given epinephrine injection in Rt thigh & 25 my Benadryl in Rt arm about an hour after vaccination.
53 2021-05-02 white blood cell count increased 4/22/21- Cough, body aches, Sore throat- Drive up COVID test 4/27/21- Cough, increased SOB- Office v... Read more
4/22/21- Cough, body aches, Sore throat- Drive up COVID test 4/27/21- Cough, increased SOB- Office visit, CBC, CMP. Given Augmentin, Azithromycin and Prednisone 4/30/21- Increased SOB- Office Visit, CBC, CMP, COVID CT and US
53 2021-05-03 lymph node swelling Large, painful (golf-ball size) swollen lump in armpit of vaccinated arm.
53 2021-05-04 lymph node swelling PATIENT STATES THAT WITHIN 2 WEEKS OF THE FIRST VACCINE SHE NOTICED BREAST SWELLING, NIPPLE INVERSIO... Read more
PATIENT STATES THAT WITHIN 2 WEEKS OF THE FIRST VACCINE SHE NOTICED BREAST SWELLING, NIPPLE INVERSION AND TENDER AXILA OF THE RIGHT BREAST. SHE RECEIVED THE SECOND VACCINE AS TOLD TO DO . SHE CAME IN FOR AN EXAM ON 4-16-21 AND WAS SENT FOR EVALUATION BY MAMMOGRAM.
53 2021-05-04 peripheral swelling the right arm is roughly 2" bigger than the left arm around it.; inflamed; Thought it was dry skin. ... Read more
the right arm is roughly 2" bigger than the left arm around it.; inflamed; Thought it was dry skin. That area is prone to dry skin.; pretty tired; shortness of breath; chest pain; rash/rash around right arm; Redness in right arm at mastectomy site, and warm to touch; Welts; red bumps; Itching; Nauseated; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the second dose of BNT162B2, via an unspecified route of administration in left deltoid on 19Apr2021 14:30 at single dose for COVID-19 immunisation. Medical history bipolar disorder, breast cancer, and slightly high blood pressure. Patient had a right mastectomy and had lymph nodes removed from the right side. In the spring, when everyone was mowing grass and it was real humid outside, she got welts on her body. It was temporary and went away. Patient would get really itchy. Concomitant medications included letrozole for breast cancer (the tumor in her breast was powered by hormones. This drug suppressed hormones) from 2017 and ongoing, omeprazole for constant heartburn from an unspecified date and ongoing, propranolol hydrochloride (PROPANOLOL) for anxiety from 2016 and ongoing, clonazepam for anxiety from 2016 and ongoing, and venlafaxine hydrochloride (EFFEXOR) for bipolar disorder from an unspecified start date and ongoing. Patient previously received the first dose of BNT162B2 in left deltoid on 29Mar2021 11:30 for COVID-19 immunisation and was really tired after the first vaccine. When she was a kid, her doctor put her on steroids. Never happened after age 12. Patient also got the influenza vaccine (flu shot) a couple of years before. The patient experienced redness in right arm at mastectomy site, and warm to touch, welts, red bumps, itching, and nauseated on 20Apr2021. Patient had a right mastectomy and had lymph nodes removed from the right side. In the area where that occurred, it had become red, inflamed, and a little welty. Not all of the welts were raised, they look like they were in the skin. There was redness and it was like someone scratched her and was kind of itchy. She took 2 diphenhydramine hydrochloride (BENADRYL). Patient was very sensitive to allergies, but was not allergic to anything. Sometimes she broke out in welts in the spring. Patient got the injection in the left side but the reaction was occurring in the right side. Patient was pretty tired, but she was concerned about the rash. Patient was concerned that the right arm was roughly 2" bigger than the left arm around it. Patient had been measuring the circumference, because nurses were paranoid about things like that. It was usually not 2" more around. Patient woke up this around 10:00 am. Around roughly 12:20 pm, or probably 10 after 12, she looked in the mirror and said there it was. She noticed the itching and thought it was dry skin. That area was prone to dry skin. The welty points of redness that were raised. It looked like someone had scratched across the area. It was red, and might be the end of one red scratchy area might be a bump. It looked like, if were to put hand where the nipple used to be and open up the area. That would all be covered. It included the upper arm and the inside of the shoulder, like the front side of the shoulder. It was raised and welty redness. Not all areas were raised and was bumpy. It was all pretty red and warm to the touch. The itchiness started more after she saw it, which was terrible. Patient took diphenhydramine hydrochloride because she was concerned about an allergic reaction. She also had scheduled medications that she took in the morning. Patient took 50 mg diphenhydramine hydrochloride this morning. Patient took at 12:10 pm when noticed these things. At first, she didn't think anything, she didn't think like it was the Pfizer shot or anything. It was just a normal day. Diphenhydramine hydrochloride had done nothing for the welts yet. Patient then felt kind of nauseated. It started when we first got on the phone. She couldn't put her finger on it. Patient went to the emergency room last Monday. The incident had nothing to do with any vaccine. She had chest pain and shortness of breath. They drew all of the labs. If she wanted to know if anything in the labs was different from then and now, she could. Everything was normal. She got an inhaler. They though it might be related to all of her allergies. The only way she would go see a doctor, is if she saw that the arm was getting much bigger, like it grew 2" more. If she had a hard time breathing, she would call 911. Patient had rash around right arm on 20Apr2021, in area of past breast mastectomy. Patient first noticed itching and the redness around 12:20 pm on 20Apr2021. Had gotten progressively worse. Patient did not see in the emergency department and was not hospitalized. Patient was not admitted to an Intensive Care Unit. Multiorgan were involved. Patient just noticed new area that formed. There were lines coming out of the area and came below the sleeve line. The red rash was spreading. It looked like something invisible scratched it. There was a triangle of three dots with a little scratch mark below the sleeve. There was another dot area on the forearm that itches, just like the other stuff did. Stomach had been feeling a little jumpy. Patient had already eaten breakfast. It was not horrible. Patient would watch it and drink ginger ale. Patient was asking what parameters should be for calling 911. She was home alone. This was not life threatening but if it turned into something bigger or if she noticed getting a bigger rash, she might have to call 911. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
53 2021-05-05 guillain-barre syndrome Guillain Barre Acute severe bilateral leg pain (3/30/2021), tingling, subsequent foot drop (4/13/21)
53 2021-05-05 lymph node swelling Lemon size swollen lymph node in axilla. Denied redness or warmth. C/O constant pain in Left arm a... Read more
Lemon size swollen lymph node in axilla. Denied redness or warmth. C/O constant pain in Left arm and pain increases with activity with pain more concentrated in L) elbow. Pain wakes her up at night. Took aleve, used heat and biofreeze to alleviate pain and didn't help. When having pain with activity c/o pain 7-8. 5/5/2021: Saw primary care provider. Started on Aleve 4 tabs daily for a week and Gabapentin 300mg PO daily.
53 2021-05-05 swelling Patient called pharmacy stating, unlike with the first dose, she now has a swollen, itchy raised bum... Read more
Patient called pharmacy stating, unlike with the first dose, she now has a swollen, itchy raised bump that is hot to the touch. States previous lifestyle caused several abscesses and this reaction feels similar albeit not as bad. Patient stated she has no symptoms beyond local symptoms. Advised patient that while some injection site reactions are to be expected that there can also be possibility for infections. Advised patient to reach out to primary care provider for observation if symptoms persisted or worsened in next 24-48 hours. Patient stated this is something that she can keep an eye on and will seek treatment if condition worsens.
53 2021-05-06 lymph node pain, lymph node swelling 1) pain and swelling in arm at/near injection site - started ~12 hrs after shot; much worse at 24 hr... Read more
1) pain and swelling in arm at/near injection site - started ~12 hrs after shot; much worse at 24 hrs after; still lingering at 7 days after. 2) pain and swelling of lymph node in armpit of arm that received injection - started ~24 hrs after shot; got worse over 2-3 days, then slowly started improving; still painful at 7 days after and worsened with exercise on day 7 (did not try to exercise until day 7). 3) fever, 99F to max of ~101 F - started ~24 hrs after shot; lasted ~1.5 days 4) headache - started ~12 hrs after shot; lasted ~2 days 5) body aches - started ~12 hrs after shot; lasted ~2 days 6) loss of appetite - started ~18 hrs after shot; lasted 1-2 days
53 2021-05-06 lymph node swelling Pain in armpit and upper back side of arm. Sore when touched. Swelling of lymph nodes in armpit. Sor... Read more
Pain in armpit and upper back side of arm. Sore when touched. Swelling of lymph nodes in armpit. Soreness, swelling, and pain decreasing over time but still present today, May 7th.
53 2021-05-06 lymph node swelling swelling of mouth, tongue and gums (resolved in 5 days) ; "pins and needles throughout body includin... Read more
swelling of mouth, tongue and gums (resolved in 5 days) ; "pins and needles throughout body including face" (resolved in 5 days); swelling in lymph nodes (greater swelling on vaccination side), resolved in 9 days. Reported to Dr. to confirm no known interaction with Trulicity.
53 2021-05-07 neck mass First symptoms were various lumps on my face and neck, which have not dissipated. The first were by ... Read more
First symptoms were various lumps on my face and neck, which have not dissipated. The first were by my lips and on my chin, followed by my neck and jawline. As of 2:30 am on 5-8-21, I have a severe sore throat which has not been eased by my usual methods of taking Advil cold & sinus and gargling with hot salt water. As I am reporting the severe sore throat at 3:47 am on 5-8-21, I do not know yet if I will be required to see a doctor. I consulted with my doctor about the skin effects, but she said that there was nothing that could be done for them.
53 2021-05-10 lymph node swelling, lymph node pain swooning feeling when elevating body temp (taking a bath); Fever; chills; body ache; headache; tremo... Read more
swooning feeling when elevating body temp (taking a bath); Fever; chills; body ache; headache; tremors; swollen sore lymph nodes (one week later under LEFT arm); swollen sore lymph nodes (one week later under LEFT arm); dizzy; extreme fatigue; elevated/irregular resting heart rate; elevated/irregular resting heart rate; weakness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 08Apr2021 08:15 (Lot Number: Ep7533) as SINGLE DOSE for covid-19 immunization. Patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose of vaccine in Arm left on 11Mar2021 08:15 AM (Lot Number: En6201) also at age of 53 years old for covid-19 immunization, experienced elevated resting heart rate, weakness, dizzy, extreme fatigue, headache. Medical history included Hashimoto hypothyroidism. Concomitant medications included levothyroxine; estradiol; progesterone; testosterone, all taken for an unspecified indication, start and stop date were not reported. The patient experienced fever, chills, body ache, headache, tremors, swollen sore lymph nodes (one week later under left arm), dizzy, extreme fatigue, elevated/irregular resting heart rate, swooning feeling when elevating body temperature. The events onset date were reported as on 09Apr2021 06:00 AM. It's unknown if patient received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
53 2021-05-10 lymph node swelling Swollen Lymph nodes (under right arm and neck); Nausea; Tiredness; Chills; Headache; Muscle pain; Jo... Read more
Swollen Lymph nodes (under right arm and neck); Nausea; Tiredness; Chills; Headache; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0150), via an unspecified route of administration in right arm on 10Apr2021 (at the age of 53-years-old) at 10:15 at single dose for COVID-19 immunization. The patient's medical history included sleep apnea, sulfonamide allergy and prediabetes. Concomitant medications included vitamin D and vitamin C. Prior to vaccination, the patient was not diagnosed with COVID-19 and was not pregnant. The patient experienced swollen lymph nodes (under right arm and neck), nausea, chills, headache, muscle pain, tiredness, and joint pain on 11Apr2021. The events were reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment of Naproxen 500mg. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was reported as recovering. No follow-up attempts are possible; No further information is expected.
53 2021-05-10 lymph node swelling Felt stinging in my right arm soon after vaccine injection; Felt slight sting in my neck and somethi... Read more
Felt stinging in my right arm soon after vaccine injection; Felt slight sting in my neck and something minor by my ear; Woke up with a very groggy feeling; couldn't look at self in the mirror and focus; arm was minorly sore; congestion in my head; fogginess; swollen lymph node behind my right ear; minor ache in right side of head/mild aching; sinus pressure in front of face now-near eyes and nose/sinus pressure; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 53-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8737) via an unspecified route of administration in the right arm on 31Mar2021 at 15:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies, asthma as a child and some sinus infection history which was reported as not usual, all from unknown dates and unknown if ongoing. The patient had no allergies to medications, foods or other product. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. Concomitant medications included Proflora women's Probiotic, Prebiotic, and cranberry, all from unknown dates for unknown indications. The patient reported that on 01Apr2021 at 08:00 she felt stinging in her right arm soon after vaccine injection and slight stinging in her neck and something minor by her ear. She reported the next day she woke up with a very groggy feeling and couldn't look at herself in the mirror and focus. She reported that on day 1 her arm was minorly sore, but this went away after day 2; she felt congestion in her head, fogginess, and swollen lymph node behind her right ear for 7 days. The reporter stated, "was thinking did the vaccine travel up to my head? Did I have a sinus infection?" The patient made appointments with an ear, nose, and throat doctor and a neurologist. The patient reported she improved slowly over 7 days and by day 8 still minor ache in the right side of head, ear node better. She reported day 9 sinus pressure in front of face now-near eyes and nose; day 10 mostly better in head but still some aching and sinus pressure, grogginess gone. No treatment was received for the events. The events required a physician office visit. The clinical outcomes of felt stinging in her right arm soon after vaccination, felt sting in her neck and something minor by her ear, woke up with a very groggy feeling, couldn't look at self in mirror and focus, swollen lymph node behind her right ear, arm was minorly sore, congestion in her head, fogginess, minor ache in right side of head/mild aching, and sinus pressure were recovered with sequel in Apr2021. No follow-up attempts are needed. No further information is expected.
53 2021-05-11 swelling face Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of... Read more
Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: PATIENT COMPLAINT ABOUT SWELLING AND REDNESS ON EYE AND FACE; PATIENT WAS CONTACTED 4HRS LATER AND WAS BETTER AFTER TAKING BENADRYL. SHE DECIDES TO SEE HER PCP AFTER
53 2021-05-11 swelling face Please see Continuation Page below
53 2021-05-12 lymph node swelling Swollen lymph node on left side of neck
53 2021-05-12 peripheral swelling Diagnosed with cellulitis in left arm. Left arm swollen, red and warm to the touch. Symptoms on May ... Read more
Diagnosed with cellulitis in left arm. Left arm swollen, red and warm to the touch. Symptoms on May 9-May 11 were fever, body aches, mild headache and eyes and nose running.
53 2021-05-12 swelling SWOLLEN LINGUAL FRENULUM - PER DR GOOGLE THIS CAN BE A REACTION TO A VACCINE - SEE LINK BELOW http... Read more
SWOLLEN LINGUAL FRENULUM - PER DR GOOGLE THIS CAN BE A REACTION TO A VACCINE - SEE LINK BELOW https://www.jaci-inpractice.org/article/S2213-2198(18)30586-5/abstract
53 2021-05-12 white blood cell count increased, c-reactive protein increased shortly after vaccine, experience chest tightness, palpitations, dyspnea, cough, sweating and fever.... Read more
shortly after vaccine, experience chest tightness, palpitations, dyspnea, cough, sweating and fever. Admitted to hospital 3 days later, found to have new pericardial effusion, secondary to acute pericarditis from possible vaccine. Pericardiocentesis removed 250ml proteinaceous material. Also experienced flash pulmonary edema which required intubation x1 day but resolved quickly.
53 2021-05-13 swelling face Face got shingles on its left side by my mouth but it's not a cold sore; red, hurt, little blisters ... Read more
Face got shingles on its left side by my mouth but it's not a cold sore; red, hurt, little blisters and itching on left side of my face; it's gotten bitter; side of my face by my mouth is red, it hurt, little blisters; side of my face by my mouth is red, it hurt, little blisters; they are itching this is on the left side of my face; side of my face by my mouth is red, it hurt, little blisters; Feels like my face is swelling; Left eye is itchy; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 22Apr2021 (Batch/Lot Number: ER8732) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included: Allergy, double amputee. Concomitant medications included lamotrigine (LAMOTRIGINE); alprazolam (XANAX); venlafaxine (VENLAFAXINE); aripiprazole (ABILIFY); diclofenac diethylamine (DIFENAC [DICLOFENAC DIETHYLAMINE]); diphenhydramine hydrochloride (BENADRYL); ibuprofen (IBUPROFEN); eszopiclone (LUNESTA); budesonide, formoterol fumarate (SYMBICORT); (ALBUTEROL); all taken for unspecified indications, start and stop dates were not reported. The patient had her (first) Covid shot yesterday and her face got shingles on it now and it's on the left side by her mouth but it's not a cold sore. Reported as "shingles, on the side of my face by my mouth is red, it hurt, little blisters and they are itching this is on the left side of my face/ Face got shingles on its left side by my mouth but it's not a cold sore; red, hurt, little blisters and itching on left side of my face; it's gotten bitter. My left eye is itchy and it feels like my face is swelling." The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
53 2021-05-14 anaphylactic reaction anaphylaxis; This is a spontaneous report received a contactable consumer (patient) from a 53-years-... Read more
anaphylaxis; This is a spontaneous report received a contactable consumer (patient) from a 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot Number: EP6955, expiry date not reported) via an unspecified route of administration on 30Mar2021 as first dose, single for covid-19 immunisation. Medical history included asthma and autoimmune disorder, both from an unknown date and unknown if ongoing. Patient received her 1st dose on 30Mar2021 but experienced a bad reaction (anaphylaxis) on an unspecified date in 2021. She was afraid to take her 2nd dose since its risky. She was asking if she can take an alternative vaccine for her 2nd dose (Moderna) or she needs to stop. She needed to know how to move forward for dose 2. She needed hospitalizing and it was to the point she needed to call 911 but it resolved and materialized at home. She clarified that instead of going to the hospital it was a close call at home. She said she used her rescue inhaler because she was an asthma person. She used her rescue inhaler over the course of a few days and it resulted in settling the issue. It lasted several days. She needed to also submit a safety report over to VAERS. She wanted to submit over there as well, online or call in. Her question was she had a really bad case and nearly had to go to the ER and thought she would die with dose 1, she waned to know if she should get dose 2. She looked it up through the CDC and it says do not continue dose if she had anaphylaxis. She reached out because she does not feel comfortable about the adverse effects. If she experienced adverse effects, she asks if she can get a different vaccine. The CDC website says she may chose to take different vaccine. She wants to know if she can take another vaccine. She wants to know what's in the Pfizer vaccine, asking what are in the ingredients. Right now, she has one vaccine in the system. She wanted to know how effective is it to prevent her from catching covid. How much protection does she have from one dose. The lady just read the statement to her that people who are immunocompromised she was told something that it would have a lower effect with the vaccine. She would like to file an official report with VAERS she wants to receive the information she needs about the vaccine through Pfizer and move forward. She contacted the CDC and usually with adverse effects Pfizer uses the reports of the vaccine. If she has need or medical assistance needed or she doesn't know reimbursement billing. If a medical fee was incurred. She said she had to get a chest x-ray on an unknown date with unknown result and it was an emergency she had to go to the doctor which was a medical expense. She wanted to know if she will be refunded. There is compensation on the FDA's website. On the website from the CDC that says Pfizer has compensation for reaction for the shot for medical expenses. She was informed that she would have to submit a written request to the legal department by mail. She repeatedly asked for a direct phone number for the legal department. She stated her lawyer would not know how to file the claim she would be mailing to them and asked if there is a website to know how to file the claim. Her legal papers. She stated Pfizer cannot be sued they are covered by the government. She wanted to know how effective is it to prevent her from catching covid and stated "the lady just read the statement that people who are immunocompromised have a lower effect with the vaccine". The event was reported as medically significant and life-threatening and patient stated that it had caused her for a physician visit. The patient recovered from anaphylaxis on an unspecified date in 2021.
53 2021-05-14 lymph node swelling Swollen lymph node in the neck.Congestion and mucus green and yellow?s color
53 2021-05-15 lymph node swelling, lymph node pain Sore arm as site, then chills, and Headache, and feeling of unwell. Then ache joints. Lost of app... Read more
Sore arm as site, then chills, and Headache, and feeling of unwell. Then ache joints. Lost of appetite and nasuea. and fatigue. Headache, and feeling of unwell ache joints lasted about 24 hour. Lost of appetite lasted about 3 days, Fatigue still have at day 6. Left arm lymph nodes started hurting and swollen about 48 hours after and lasted for 3 days.
53 2021-05-16 lymph node pain, lymph node swelling Started with 100.6 fever at 3am- 10pm following day 5/15/21 along with stomach ache, nausea and hea... Read more
Started with 100.6 fever at 3am- 10pm following day 5/15/21 along with stomach ache, nausea and headache 5/16/21 right underarm lymph node began slightly. Dark yellow pee, once. 5/17/21 - woke up with swollen lymph nodes, underarms and left side neck, right arm lymph node, painful.
53 2021-05-16 lymph node swelling Lymph nodes under my arm swelled up two days after second injection. Day three my underarm and brea... Read more
Lymph nodes under my arm swelled up two days after second injection. Day three my underarm and breast became very painful, felt like a burning sensation, even as swelling went down. This lasted over three weeks. I went to my OBGYN after two weeks who gave me a breast exam and stated it was reactive tissue from the vaccine.
53 2021-05-16 swelling Client reports on the morning after receiving her vaccine she experienced left sided sore throat pa... Read more
Client reports on the morning after receiving her vaccine she experienced left sided sore throat pain that progressed to spine pain and swelling at injection site up her neck and to L eye area. Symptoms lasted approximately 3-4 days. "It was concerning enough that I don't want to get the second vaccine".
53 2021-05-17 lymph node swelling I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I... Read more
I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on Apr2021 03:00 PM (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included prior to vaccination, the patient was diagnosed with COVID-19; had known allergies and other medical history. The patient had other medications received within 2 weeks of vaccination, name was unspecified. Reported Event: I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes. The events resulted in Emergency room/department or urgent care. adverse event start date 27Apr2021, adverse event start time 03:00 PM. No treatment received for events. The Serious was reported as No. The event outcome was not recovered. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
53 2021-05-19 peripheral swelling pneumonia; I've been very very sick; body ache; chills; nausea; so tired/very exhausted; fever 99.3F... Read more
pneumonia; I've been very very sick; body ache; chills; nausea; so tired/very exhausted; fever 99.3F; a very strong headache; sore throat; The arm is very hot and swelling; The arm is very hot and swelling; pain in the back, neck and everything; pain in the back, neck and everything; shortness of breath; My eyes are so hot and burning; earache; she is not feeling very well; she had a really sore arm in the area of the shot; her head is foggy this morning and all day; This is a spontaneous report from a contactable consumer. A 54-year-old female patient (Age at time of vaccination 54 years) received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 04May2021 at 16:00 (Batch/Lot Number: EW0176) as SINGLE DOSE for covid-19 immunization. Medical history included back injury, neck injury, Knee Surgeries, 2 Bulging Discs, Heel Spurs and Sciatic all on the left ongoing since 2010 and Covid-19 on 29Mar2020. The patient's concomitant medications were not reported. The patient experienced pneumonia, i've been very very sick, body ache, chills, nausea, so tired/very exhausted, fever 99.3f, a very strong headache, sore throat, the arm is very hot and swelling, pain in the back, neck and everything, shortness of breath, my eyes are so hot and burning, earache, she is not feeling very well, she had a really sore arm in the area of the shot and her head is foggy this morning and all day all on 05May2021. Consumer reported "Since this morning I've been very very sick. I'm sick. I have body ache, chills, nausea, so tired, fever 99.3F, a very strong headache, sore throat. The arm is very hot and swelling. I had Tylenol this morning nothing is working. The body ache is so horrible, pain in the back, neck and everything. I had covid on march 29 last year, I had pneumonia. I have lingering issues, body ache and pain, I still get very tired, shortness of breath; I feel like it's coming back after getting the vaccine. My eyes are so hot and burning, you know the sensation when you have a fever. Commented how she felt like she was getting covid again after getting the vaccine. Yesterday, 04MAY2021, she was vaccinated with the Pfizer Covid Vaccine. States it was her first dose and she is having a lot of side effects. Her temperature is 99.2, she has body aches, earache, headache, a little bit of shortness of breath, very tired, very exhausted and she is not feeling very well. She is wondering if this is a normal reaction for the first vaccine? States it feels like when she had Covid. Clarifies at she was fine last night other than she had a really sore arm in the area of the shot and it is really hot, like if she has a fever in the area. States at 9:30-10:00 a.m. this morning she started having a headache, chills, and nausea. She took a hot shower, and had some tea and took Tylenol. It is progressing worse and worse. States she has body aches and fever getting warmer and warmer, and her throat feels a little bit sore. States all of them are getting worse. She is staying home and laying down not trying to do a lot, drinking water and staying hydrated. States she spoke to a friend and she said she is not supposed to get these side effects with first one. Her body aches are horrible, it feels like when she got the virus, all the aches and pains. Her head is foggy this morning and all day, and she has issues with pain all over, so much body aches. States she is reporting her side effects and she read the side effects but it seems like when she had Covid last March and she is still going through a lot of issues with it, the pain Covid left her with. States she did a Covid test, and she had antibodies, but this feels like the virus again. States she has the same symptoms as when she got the virus. Treatment: Took 2 Tylenol and nothing seems to help. UPC and Expiration: Unknown Lot: 110856. Caller states the UPC and Expiration got erased because she has had it for awhile. Tylenol Rapid Release 500mg.Caller states she took a hot shower, and had some tea. Caller states she is staying home and laying down not trying to do a lot, drinking water and staying hydrated. The outcome of the event pneumonia was unknown. Outcome of all the other events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
53 2021-05-19 peripheral swelling "Big bright red and slightly swollen arm" She stated the redness was "Red as a Dodgeball" onset 05.... Read more
"Big bright red and slightly swollen arm" She stated the redness was "Red as a Dodgeball" onset 05.05.21 thru 05.08.21. . She also report generalized malaise "Tired & no Energy" during the same time frame. She did not call her allergist or PCP as advised date of injection if she were to have a reaction/side effects.
53 2021-05-19 swelling face, peripheral swelling Swelling of feet, legs, hands, arms and face; Swelling of feet, legs, hands, arms and face; itching ... Read more
Swelling of feet, legs, hands, arms and face; Swelling of feet, legs, hands, arms and face; itching in face and neck; This is a spontaneous report from a contactable consumer (Patient). A 53-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 17:30 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation at the age of 53-year-old. Medical history included severe back issues and "I have had 6 back surgeries", allergy to all Nsaids. The patient previously received bnt162b2, dose 1 administered in Arm Left on 16Mar2021 08:30 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation at the age of 53-year-old. Concomitant medications included hydrocodone, cefixime (FLEXERIL [CEFIXIME]), buprenorphine hydrochloride (BELBUCA), atorvastatin, clarithromycin, omeprazole, tinidazole (OTC-HP) taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and hasn't been tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling of feet, legs, hands, arms and face, itching in face and neck on 07Apr2021 02:00 with outcome of recovered in 2021. Therapeutic measures taken to all events included Benadryl and prescribed EpiPen. The events were assessed as medically significant. The events resulted in Emergency room/department or urgent care visit. It was reported as: Swelling of feet, legs, hands, arms and face as well as itching in face and neck after about 8 hours of receiving 2nd dose. 1st dose was unremarkable. The lot/batch number has been requested.
53 2021-05-19 swelling face I had the vaccine and after 10 minutes after my throat and esophagus were itching but it didn't clos... Read more
I had the vaccine and after 10 minutes after my throat and esophagus were itching but it didn't close up, they gave me water and I was able to drink it but someone told me I was flushing and my heart rate increased and they had EpiPen's ready but they wanted to do liquid Benadryl first and it calm everything down. The next day about noon time my face turn bright red and my right side was swollen and I did more liquid Benadryl and that was fine. 2 days after the shot my arm was itchy and the next day my arms were fine but the next day my legs were itchy and I took more liquid Benadryl and then I was fine after that. My doctor told me to not take the 2nd vaccine because of my allergic reaction.
53 2021-05-19 swelling face face swelling; cheeks were red and hot; cheeks were red and hot; hives on my neck; Allergic reaction... Read more
face swelling; cheeks were red and hot; cheeks were red and hot; hives on my neck; Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0169, expiration date not provided), 1st dose via an unspecified route of administration, administered in arm right on 20Apr2021 at age of 53 years old as a single dose for COVID-19 immunisation. Medical history included anxiety, known allergies: fruits with a seed in the center i.e. peaches, cherries, apricots etc (fruit allergy). Concomitant medication included sertraline. The patient experienced allergic reaction including face swelling, cheeks were red and hot and hives on my neck., all on 20Apr2021 12:30. No treatment received for the events. The outcome of the events was recovered in 2021. The report was reported as non-serious by reporter. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.
53 2021-05-20 oral herpes Fever blister. Treating with blistex
53 2021-05-22 swelling, swelling face Noticed 4/5 days later that my face had swollen, and broken out a bit but not serious to go to ER. D... Read more
Noticed 4/5 days later that my face had swollen, and broken out a bit but not serious to go to ER. Days later, swelling is all over my body; hands, face, legs, knees, feet, arms. I feel extremely heavy and in much pain from the gain on my legs. I weighed 143 day of shot...4/5 days later 10 pounds happened, but not from eating...its swelling.
53 2021-05-24 peripheral swelling Swelling arms , legs rapid heart rate and kidney failure, abnormal blood tests results.
53 2021-05-24 white blood cell count increased patient reports fevers, malaise and headaches since receiving her first shot on 3/30/21. Tolerated... Read more
patient reports fevers, malaise and headaches since receiving her first shot on 3/30/21. Tolerated the first shot on 3/9/21
53 2021-05-25 lymph node swelling Swollen lymph nodes under right arm; This is a spontaneous report from a contactable Healthcare Prof... Read more
Swollen lymph nodes under right arm; This is a spontaneous report from a contactable Healthcare Professional reporting for herself. A 53-years-old, non-pregnant, female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine in Hospital, via an unspecified route of administration, administered in right arm on 20Feb2021 09:30 (Batch/Lot Number: EN6200) as single dose for COVID-19 immunization. The patient's medical history was not reported. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine in right arm on 25Jan2021 06:00 PM (Batch/Lot Number: EL8982) as single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID post vaccination. Concomitant medication included omeprazole taken for an unspecified indication, start and stop date were not reported. The patient experienced swollen lymph nodes under right arm on 22Feb2021 06:00. No treatment was administered for the event. The event had not resolved yet at the time of the report. No follow-up attempts are possible. No further information is expected.
53 2021-05-26 peripheral swelling I woke up today May 27 with COVID arm. Raised but not itchy. Keeping tabs on it. Sent a message to m... Read more
I woke up today May 27 with COVID arm. Raised but not itchy. Keeping tabs on it. Sent a message to my primary making them aware. I will enter the info in VSAFE when I receive today's text link.
53 2021-05-27 lymph node swelling severe Dysuria tested positive for HSV1 Genital; Low WBC count and low lymphocytes; Low WBC count an... Read more
severe Dysuria tested positive for HSV1 Genital; Low WBC count and low lymphocytes; Low WBC count and low lymphocytes; patient developed 102.6 fever; nausea; Swollen groin lymph nodes; kidney infection; severe UTI; the patient experienced bad leg pain; rash on legs; This is a spontaneous report from a contactable other hcp (patient). A 53-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 22Apr2021 13:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included breast cancer and Hashimoto disease. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 at the age of 53-years-old on 01Apr2021 12:30 in the arm right for COVID-19 immunization. On 02May2021 22:00, the patient experienced bad leg pain, rash on legs, flowed by severe UTI and kidney infection. On 05May2021, day 3, the patient developed 102.6 fever, nausea, swollen groin lymph nodes, severe dysuria tested positive for HSV1 Genital, with bad lower pelvic pain, low WBC counts and low lymphocytes. The patient had 2 trips to ER in 3 days, missed 8 days of work due to the events. The patient received IV fluids, IV antibiotic, IV pain meds, anti-nausea as treatment for the events. The outcome of the event was recovered with sequel. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events and suspect drug BNT162B2 Cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.
53 2021-05-27 swelling face After 1st dose, had tingling and numbness on face, lips, tongue and all through right arm/hand/fing... Read more
After 1st dose, had tingling and numbness on face, lips, tongue and all through right arm/hand/fingers; tingling on lips and tongue lasted for about 24-26 hours; throat tightness about 7 hours; face/cheeks were flushed, hot/warm, and slightly swollen; hand, arm, and lips still have occasional periods of tingling/numbness through current date
53 2021-05-28 swelling face left side of cheek close to left bottom lip swollen; lips swelled; This is a spontaneous report from... Read more
left side of cheek close to left bottom lip swollen; lips swelled; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 53-year-old female patient (no pregnancy) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 06May2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. Medical history included allergies: Benzoyl peroxide. The patient received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 at 04:00 PM (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's concomitant medications were not reported. The patient experienced lips swelled at 4:00 am on 09May2021, she went to urgent care, took a corticosteroid shot, was put on steroids for a week; finished on 15May2021. On 17May2021, the patient woke up with her left side of her cheek close to her left bottom lip swollen. She was at the hospital now. This case was provided as non-serious by reporter. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The adverse event resulted doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment (steroid shot and medication) received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in May2021.
53 2021-05-28 swelling Within 3 hours of getting the vaccine on May 14, 2021 I could not bend my right leg, could not squat... Read more
Within 3 hours of getting the vaccine on May 14, 2021 I could not bend my right leg, could not squat down, and had terrible pain throughout the back of my right calf and surrounding my knee and upper right thigh. During the next 2 days the pain increased and the swelling increased to become very visible to others. The muscles in my calf and thigh were so tight and so bound up that it looked like balls under the skin, as if I was in a constant state of chronic, extreme charlie horse. And that is also what it felt like. So very painful that I could not bear my own weight without crying. By Tuesday, May 18, 4 days later, I was having to use a cane or have someone by my side because the pain was so extreme and my right leg would spasm and buckle without warning. I called my doctor and made an appt. Pain continued throughout the week. I had to switch to a walker. I saw my doctor on Friday May 21st at 11 a.m. He was concerned about the vaccine causing blood clotting and due to the swelling, binding of muscles, and pain that he noted, he ordered an ultrasound for later that day. I had the ultrasound at 2 p.m.. My results were negative for blood clots. I went home to ice my leg and elevate it until I could see a Dr again the next week as it was now after hours and the weekend. At or around 6:30 p.m. that same night, Friday, May 21, I was standing up at my dining room table and felt and heard a horrific snap or pop. It was so excruciating. I fell to the floor and landed on my bottom first and then my back and right shoulder. I had to be allowed to lay on the floor for at least 20 minutes before I could calm myself from the pain and fear of being lifted off of the floor. I required being carried to my chair because when I tried to walk, my right foot would just drag. I could not lift it at this time. My family decided I needed to go to the emergency room, as did the on-call after hours doctor at my doctor's office whom I called. I was taken to the hospital because when we called they said they would do an MRI in the E.R. We had to use a wheelchair. After admitting me and going through all of the events, they informed me that they would not do MRI's in the E.R. unless the patient met a certain criteria of trauma and I did not..in their opinion. They sent me home with crutches and prescriptions. That weekend was pure hell, although, the muscles seemed to be diminishing in hardness and tightness and swelling with each day after I felt the snap. Regardless, I called my niece on Sunday to ask her to come stay with me and help take care of me until someone would order an MRI because the horrific pain was still there at random moments of trying to maneuver myself to the bathroom and bed. Finally, an MRI was ordered and I had it done on Wednesday, May 26, at 4:00 p.m.. I did not get the results until Friday, May 28, at appx 4 p.m. Full Thickness Tear in the Posterior Horn Medial Meniscus. It is my own and my family's absolute belief that the Phizer shot caused the binding of my leg muscles, of which they were relentlessly bound for almost 2 weeks, with the 1st week being the most painful and traumatic, subsequently causing my meniscus to snap. Even my Dr believed it was a possibility because of the stats on the vaccine and the fact that I had not injured myself previously or on the day of the vaccination. The pressure that was put on those muscles from the binding/balling and swelling were too much for my muscles and tendons to withstand. The Dr bills, the ultrasound, the E.R. bills, the crutches, the prescriptions, the MRI will all be coming out of my pocket because I am an uninsured, unemployed woman trying to protect herself and her community by getting a vaccination that was supposed to be a positive thing. Only, instead, it has crippled me and now...now, I have to figure out how to come up with money for surgery, rehab, etc. Where is the justice in this? The fairness? The peace of mind? The safety? I want a phone call, in the least, from someone of the highest rank to help me understand all of this and what anyone intends to do about it. This is not acceptable, nor is it my responsibility.
53 2021-05-31 swelling face Swelling of tongue and face near right lower lip.
53 2021-06-01 lymph node swelling Caller experienced swelling of the eyelid after receiving the second dose of the vaccine; swollen ly... Read more
Caller experienced swelling of the eyelid after receiving the second dose of the vaccine; swollen lymph nodes; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21May2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) for covid-19 immunization. On 21May2021, the patient experienced swelling of the eyelid after receiving the second dose of the vaccine and also experienced swollen lymph nodes and has been using cold compresses and tea bags to remedy the swelling. Patient also mentioned that she had the photos of the AE she experienced take last Wednesday (19May2021) and yesterday (21May2021). Overall safety summary included in clinical studies, adverse reactions in participants 16 years of age and older included injection site swelling (10.5%). Clinical trials experience solicited local and systemic adverse reactions across both age groups, 18 through 55 years of age and 56 years and older, mean duration of swelling 2.3 days (range 1 to 34 days). No information found for swelling specifically in the eyelid area. Referred to HCP. The events were considered as non-serious. The outcome of events was unknown. Follow up attempts are needed. Further information has been requested.
53 2021-06-01 oral herpes developed a cold sore below my lower left lip; Herpes simplex1; This is a spontaneous report from a ... Read more
developed a cold sore below my lower left lip; Herpes simplex1; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162), dose 2 via an unspecified route of administration, administered in arm left on 15Apr2021 at 09:30 (at the age of 53-years-old) as single dose for COVID-19 immunisation. The patient's medical and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), dose 1 administered in left arm on 23Mar2021 at 11:00 for COVID-19 immunisation. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Apr2021, the patient developed a cold sore below her lower left lip and Herpes simplex 1. First cold sore ever in her life. Herpes simplex 1 with COVID social distancing and constant hand sanitizing for over a year, no idea how else she contracted that, or what would trigger it if 'dormant' in her body for years. Therapeutic measures were taken as a result of the events included Valtrex and Denavir. The outcome of the events was recovering. Information on batch number has been obtained.
53 2021-06-01 peripheral swelling pain all up the arm/As time passed the pain progressed up her arm. She couldn't straighten arm at al... Read more
pain all up the arm/As time passed the pain progressed up her arm. She couldn't straighten arm at all/When she lifts her arm up, it is still sore/her right arm wrist also has pain; now she also has pain in her right wrist/pain has started to increase in her left arm wrist/her right arm wrist also has pain; swelling at the injection site; left shoulder inoculation site edema/edema is minimal; left ear was burning; left eye had floater; left hand and wrist were double the size of right hand/it was so swollen it was a bite/because of the swelling. She couldn't even bend her knuckles at all; swelling in the right wrist/wrist doubled the size of right hand/it was so swollen it was a bite; entire arm where the vaccine was given was red and swollen/swelling in her left arm has increased; entire arm where the vaccine was given was red and swollen.; arm was warm; she has cried; intramuscular pain; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0182), intramuscular at the age of 53-year-old administered in arm left on 06May2021 10:40 at single dose for covid-19 immunisation. Medical history included chronic anemia, pulmonary embolism in both lungs (doesn't remember the years but she had 4 or 5 of them/maybe between 2016 and 2019), didn't have a bladder from Apr2020 (cystoscopy performed in Apr 2020), dehiscence of wounds, gastric bypass from Jul2007, two major blood clots in right arm from 2019 (because of infiltrated IV. One was 7mm and one was 8mm. A piece broke off of one of them within 24 hours and went into right lung), Smoker, allergy to antibiotics, slightly topical itch reaction to Morphine, cat scratch infection, had a reaction to IVP dye for kidney scan where her eyes started swelling. Concomitant medication included gabapentin (NEURONTIN) taken for left knee nerve pain from Mar2021 and ongoing. The patient previously took Doxycycline and experienced anaphylactic reaction, morphine and experienced slightly topical itch reaction. She received her first Pfizer COVID19 Vaccine on 06May2021 which was a Thursday. Everything was fine. Shot was in left arm. Wednesday, last week, which was six days later she woke up with her entire left hand and wrist doubled the size of right hand on 12May2021. A friend of hers is her in home nurse because caller has underlying health issues. They thought because it was so swollen it was a bite. Caller did Benadryl and RICE treatment. As the day progressed, she had pain all up the arm on 17May2021. She had an appointment with physical therapy. They said to get to the hospital. Her nurse met her for lunch and caller's arm was warm in May2021 and her nurse said to get to the ER. They wanted to rule out a blood clot. They didn't want to admit her, but she had severe issue with her arm that day. She was given pain medication, Benadryl, and had CT scan to rule out blood clot in ER. She couldn't move her neck to the left. She was there 8 hours. While there, her left ear was burning (on 12May2021) to the point it felt someone was ripping it off. In her left eye she had floater on 12May2021, like black fuzzy lines. Everything was on the left side. She didn't hit anything in the time between receiving the injection and 6 days later. She had not done nothing out of her normal routine. It is too much of a coincidence that this is the only thing she has had in the left arm. For 2 or 3 days since last Wednesday the entire arm where the vaccine was given was red and swollen in May2021. She didn't have an immediate side effect, but 6 days later she had a great amount of side effects. She can't say it is the vaccine. She has had a flu shot every year and pneumonia shot every 5 years with no side effect. She is anaphylactic or resistant to every oral antibiotic. Even with IV antibiotics there are only certain ones that can be use, but she has to be pretreated with 50mg of IV Benadryl. She was on Doxycycline all last summer oral and IV. After 4 weeks on it she was sent home with a temp medline for IV infusion. Within 3 hours of her giving herself the next dose she had an anaphylactic reaction. Her body does not immediately react to any side effects or adverse reaction. It can be days out and it hits all of a sudden. On last Wednesday she woke up around 7AM. She felt like it woke her up because of the swelling. She couldn't even bend her knuckles at all. As time passed the pain progressed up her arm. She couldn't straighten arm at all. Everything was on that Wednesday and on the left side. She had full range of motion on the right side. The hospital said it was intramuscular and she read that could possibly be side effect. This was her first dose. Left hand and wrist were double the size of right hand: It resolved. She noticed it around 7AM as the day progressed the swelling went down a little bit. That is when the arm started hurting and the swelling would come back. The swelling wasn't as significant as it was first thing in the morning. She has pictures she can provide if needed. Pain all up the arm: the pain has resolved except for the top of the arm where she received the vaccine. When she lifts her arm up, it is still sore. It wasn't sore the first 2 to 3 days or immediately following the inoculation. It is still very mildly sore. They also did an ultrasound when in the ER. At home she takes, not for this issue, Gabapentin 3 times a day. It was just filled and is in the pharmacy vial and she doesn't have NDC, lot, and expiry. Caller clarified that it is Neurontin 300mg not Gabapentin. She has been on Neurontin since Mar2021. She takes it for left knee nerve pain. For the pain meds she was given in the ER and the Benadryl she doesn't have NDC, lot, or expiry. The hospital administered 100mg of Benadryl. When they did the CT scan they did it with contrast. 40 years ago she had a reaction to IVP dye for kidney scan where her eyes started swelling. Anytime she has contrast solution she is always treated with 50mg of IV Benadryl. She has a slightly topical itch reaction to Morphine. In the ER, they gave her 40mg of IM morphine because they couldn't get a line going. She basically has no veins. They gave her 50mg of Benadryl subcutaneously in the inner area. Then before the CT with contrast, they gave her another 50mg of Benadryl. What she took at home was off brand. It is called Banophen Diphenhydramine HCI 25mg antihistamine. She took one when the reaction happened. The manufacturer is Major. NDC: 09045551-59. When providing NDC caller states, "Come on eyes." Lot number: P121325. Expiry: Aug 2022. Caller just found a sugar cookie from Panera Bread to eat. She was in (withheld) in mid October to late October. Unfortunately when she was down there with her best friend her cat scratched her and caller ended up in the hospital because of cat scratch infection. Even though they were very cautious and following all the CDC guidelines and wearing mask when she came home for 5 days she had many COVID symptoms. She went for a rapid test and it came up negative. She has been tested 15 times since last year because she has had so many surgeries. The reason she got the vaccine was with her underlying health conditions she doesn't want to die. What is interesting is her husband and son both after she felt ill coming home had the same symptoms she did. She is scheduled to get her next dose 27May2021. Is that normal to be scheduled 3 weeks apart? Her greatest concern is her nurse provider is not familiar with her. Her GI doctor and orthopedic surgeon said she should be ok. She wants to receive both as recommended. Her concern with the second vaccine is if the side effects that she experienced could be dramatically worse or result in a horrible outcome. When she spoke to the physician and the nurses and the medical care team they said there are no studies or reports where the vaccine is causing blood clots and what she was experiencing was not associated with the vaccine. When she looked up the vaccine, it said that intramuscular issues could be a rare side effects. Her thought was that it wasn't reported that it hasn't happened. Could intramuscular issues be a rare side effect? Caller clarified that she does not have the Doxycycline or any other antibiotics that she is resistant to or had reaction with to provide NDC, lot, and expiry. The last time she had it was when she had the temp medline put in. She had the reaction and spoke to the infectious disease doctor only in hospital. She threw all the vials and all the bags away. She torn up the lot numbers. The actual bottles she soaked them and then flushed the labels down the toilet. She has chronic anemia. It has been brought to her attention lately that she has critically low iron saturation. Low saturation should be 18 and her iron saturation level was a three. She had the blood test on the same day of the vaccine on 06May2021. On the 7th she had iron infusion. The vaccine was given at 10:40AM. The blood work was drawn at 02:40PM. The iron infusion was at 9:30AM on 07May2021. She received one unit. Adds she previously reported she had gotten the Pfizer COVID 19 vaccine and six days later she had severe side effects. States she was encouraged by her health care professional to go to the ER to rule out a blood clot which she did and the result was negative. Adds when she had the first dose of the vaccine 06May2021, intramuscular in the left shoulder; she had no side effects or anything. Six days later her left hand was swollen to double the size of the right had. She took a 25mg Benadryl that did nothing, which she previously reported. Adds at lunch yesterday she spoke to a friend who is an in home care nurse who has taken care of her before because of her other medical problems; and she encouraged the caller to do RICE treatment; rest, ice, compression and elevation for her wrists. This friend saw the hand at lunch and noticed that the caller was unable to straighten the left elbow and arm; she had great pain in the left elbow and from the hand up the arm. All of these events were previously reported. Caller mentions she is in so much pain and her symptoms are getting worse. New events reported today include the pain has started to increase in her left arm wrist; swelling in her left arm has increased. Caller mentions the physical therapist saw the edema especially on the left shoulder at the vaccination (inoculation) site on 17May2021 and said there is still swelling and she had not noticed this before. Caller clarifies later that day around 1700PM 17May2021, the caller attended a physical therapy treatment and the therapist noticed swelling at the injection site on 17May2021 which was not previously reported. Adds as the day went on yesterday, her right arm wrist also has pain; since yesterday through last night and today it has been at a 10. Adds she has cried in May2021. Mentions she feels she has limited use of her fingers that she noticed yesterday when she had the wrist pain; even picking up things or trying to chop chicken, she can't; she doesn't think she mentioned particularly the left wrist yesterday. Her main concern today is that the pain in her left wrist has increased and now she also has pain in her right wrist on 17May2021. Caller adds she put muscle rubs on; and ice. Her pain in her wrists has not responded to the Gabapentin. She applied three different topical solutions with no improvement in her pain: Generic muscle rub from store; Natureplex Ultra Strength muscle rub; NDC 67324002-01; Jul2022;Topical 5% pure lidocaine cream; Lot 20G13C1; Jul2022; OTC from the pharmacy, no box. Voltaren Gel; Dec2019; lot WN791; unable to locate NDC due to pain in her wrist. Adds the swelling on both wrists is minimal but the pain is incredible; excruciating. Just the edema is minimal; she has kept ice on it on and off; 20 minutes on and off. Adds she has never had pain like this before. Caller mention she did speak with doctor yesterday. Adds she was greatly upset when they told her after she had explained all of her symptoms, that intramuscular joint pain had been detected in May2021. The events results in Emergency Room Visit. The patient underwent lab tests included blood test: unknown results on 06May2021, Iron saturation: low (Low saturation should be 18 and her iron saturation level was a three) on unknown date, CT scan (to rule out blood clot): unknown results, ultrasound: Unknown results, COVID test: negative. The outcome of event left ear was burning and left eye had floater was recovered on 12May2021, the outcome of event Swelling of wrists, Vaccination site oedema and Wrist pain was not recovered and other events was unknown.
53 2021-06-06 lymph node swelling I developed extreme sensitivity to sound first, then sycope, then vertigo (urgent care visit 3/22/21... Read more
I developed extreme sensitivity to sound first, then sycope, then vertigo (urgent care visit 3/22/21) then swollen lymph nodes affecting my swallowing and causing pressure on my heart from axilla, sub scapular and nodes near throat such that my heart started to feel the pressure so I went to the ER. Internist there suggested immediate breast diagnostics.
53 2021-06-06 swelling welts began to appear on arm and shoulder within about 1.5 hours -2 hours after injection. Hot, swo... Read more
welts began to appear on arm and shoulder within about 1.5 hours -2 hours after injection. Hot, swollen, welts
53 2021-06-07 peripheral swelling, lymph node swelling Site: Swelling at Injection Site-Medium, Systemic: Diarrhea-Medium, Systemic: Lymph Node Swelling-Me... Read more
Site: Swelling at Injection Site-Medium, Systemic: Diarrhea-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Vomiting-Medium, Additional Details: patient reported diarrhea & vomiting which made her feel weak and dehydrated that she went to ER. Pt also observed swelling under her arm, numb and tingling in the arm.
53 2021-06-08 c-reactive protein increased, peripheral swelling Symptoms: Pain, swelling, stiffness in both hands, fingers, elbows, ankles and feet with difficulty ... Read more
Symptoms: Pain, swelling, stiffness in both hands, fingers, elbows, ankles and feet with difficulty to use and walk at times thought would get better, after a few weeks went to PCP on March 9, 2021 due to worsening symptoms. Referred to Rheumatologist. 1st visit March 19, 2021 started on Hydroxychlorquine for Rheumatoid Arthritis and labs ordered. 2nd visit May 11, 2021 started on Methotrexate due to ongoing symptoms. 3rd scheduled for August 26, 2021 with labs to be done every 3 months. Continue to have issues daily and does affect my ability to continue with my prior way of life due to fatigue, pain and swelling with stiffness.
53 2021-06-08 peripheral swelling severe sharp pains in my ankle that got worse and my ankle and leg were sensitized; severe sharp pai... Read more
severe sharp pains in my ankle that got worse and my ankle and leg were sensitized; severe sharp pains in my ankle that got worse and my ankle and leg were sensitized; foot swelled up; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number not reported, patient was not pregnant and 53-years-old at the time of vaccination), via an unspecified route of administration in Arm Left on 03Mar2021 as single dose for covid-19 immunisation. The patient's medical history included High blood pressure, low blood sugar, anxiety, Ulnar nerve damage, start and stop date was not reported, Patient had known allergies with Sulphate and Dicloxacillin and baclofen. Patient had no covid prior vaccination and not tested covid post vaccination. Patient had no other vaccine in four weeks. Patient received unspecified other medications in two weeks. Reported that patient was 9 weeks into my recovery from a bimalleolar fracture. I was cleared to walk and had been doing well with minimal pain and no swelling putting 50 percent weight on my foot. Within 24 hours of getting my vaccine, my foot swelled up, I began having severe sharp pains in my ankle that got worse and my ankle and leg were sensitized. I called my doctor 5 days later and was referred to physical therapy. The only difference during this time was the vaccine. On 04Mar2021, the patient experienced severe sharp pains in my ankle that got worse and my ankle and leg were sensitized, foot swelled up. Patient received treatment with Physical therapy and Voltaren cream. The outcome of reported events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
53 2021-06-08 swelling face, peripheral swelling tiredness; back became inflamed.inflammation in her lower spine; lower back pain; annular fissures; ... Read more
tiredness; back became inflamed.inflammation in her lower spine; lower back pain; annular fissures; tingling sensation; allergic reaction to the second one; she did the 2nd dose of the Pfizer COVID Vaccine in her right thigh; face got swollen; felt dizziness; headaches; had a half an apple sized swelling in her leg for a couple of days; left side arm was weak; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received a BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in Right thigh on 02Apr2021 10:30am (at the age of 53 years) as 2nd dose, single dose for covid-19 immunisation. Medical history included brain surgery on an unspecified date in 2014 to an unknown date, facial reconstruction on an unspecified date in 2015 to an unknown date, vestibular condition from an unknown date and unknown if ongoing, muscle flap operation on an unspecified date in 2015 (Transfer from her thigh in 2015 for her left cheek so her face after brain surgery. Patient had Gracilis free flap of her right thigh and had a new cheek and had calf nerves grow back). Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Lot: EN6208) on 12Mar2021 10:30am for covid-19 immunisation and experienced dizziness, headaches, left arm, it was swollen, bell's palsy, tingly feelings, tiredness and slurring of speech. The report received as, the patient 1st dose of the Pfizer COVID Vaccine was at 10:30am on 12Mar2021 and the 2nd dose was at 10:30am on 02Apr2021. The patient had brain surgery which saved her life, the HCP said maybe patient should rethink going for the 2nd dose of the Pfizer COVID Vaccine; patient followed up with neurologist and everybody weighed in the benefits outweigh the risk and patient was got the 2nd dose. The patient states she was one of those people who had an allergic reaction to Pfizer, she had both doses. Patient states after a while, the doctor said yes the caller may want to consider getting the second dose. The patient states the benefits outweighed the risk, but the other recommendation, which was brilliant, they said get it in her leg, she did have an allergic reaction to the second one, but not same way. The patient did the 2nd dose of the Pfizer COVID Vaccine in her right thigh and had inflammation in her lower spine after that; Caller states it was the characteristic tiredness. The patient how the shot feels like a shot in the arm or a horse kicked you, states she feels like the Pfizer COVID vaccine felt like a shot in the arm but never felt that pain and had swelling and had a half an apple sized swelling in her leg for a couple of days; The patient also did not feel the face drooping because the 2nd dose of the vaccine was done in her leg. The patient started to get really bad lower back pain and went to the HCP and was maybe sitting down too much; The patient does not have proper posture sometimes and does not want to stand. The patient saw a holistic HCP which is a chiropractor, and that HCP did not touch her spine; The patient saw that HCP on 14Apr2021, and she was diagnosed with annular fissures and they thought patient had a slipped bulging disc and never had that before but had a tingling sensation and they said to take a few weeks to recover. The second time Pfizer COVID vaccine targets places that are weak and that is the weak part in her body regarding her spine. Tthough she went a week and a half later, she thought it was too much zoom fatigue, but the doctor said it sounds like annular fissures. The patient keeps seeing her HCP and has recovered and has to say as soon as they said this is probably related because patient thought the he patient left side arm was weak and the weak side of the face that was where the transfer of nerves was and that had gotten swollen and did not work, she felt dizziness, headaches, she knew what to expect, but she got worried when she was getting a little bit more droopier than usual. The patient was fine and would say patient was better and thinks patient was completely recovered and from time to time still just feels a little tingling still and did not have that before; States because of her brain surgery, the neurologist said patient can tingle independently and does not normally tingle in that area but the patient was better and 90 percent better; The HCP said to give 12 weeks to recover and will see her again next week and sees the HCP every 2-3 weeks, so this was minor. Said they needed the discs to get fluid in them, so they are healing; The neurologist was thinking of those people that as we all learn to live alongside covid she does things to avoid exposure to covid. States the HCP told her if she gets the live version of the covid virus due to how she reacted to the vaccine how would it protect her and obviously it protects her but could give her bells palsy again. The patient back was inflamed, fortunately, there was no slipped disc or bulging discs, it was just annular fissures. It was locally the right thigh, lower back, left arm, left side of the face and it's kind of thematically, spatially related. The patient underwent lab tests and procedures which included blood glucose; computerised tomogram; magnetic resonance imaging head all were normal on an unspecified date. Outcome of the events was unknown.
53 2021-06-09 swelling face Bells Palsy/ little bit more droopier than usual/facial droop; allergic reaction; blood pressure wen... Read more
Bells Palsy/ little bit more droopier than usual/facial droop; allergic reaction; blood pressure went up to normal, which was not normal for her, as its very low/ 120/70, which was normal, but not great for her and was high for her; dizziness; headaches; tingly feelings/still just felt a little tingling still; got the shot in her left arm and it was swollen; slurring of speech; face got swollen and definitely impacted her speech; This is a spontaneous report from the contactable consumer (patient herself) and physician via Medical Information. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 12Mar2021 at 10:30 at the age of 53 years old (Batch/Lot Number: en6208, Expiration date: unknown) as the 1st dose, single dose for COVID-19 immunization. Relevant medical history included brain surgery in 2014 and facial reconstruction in 2015, further reported as transplant or transfer from her thigh in 2015 for her left cheek, so her face after brain surgery in 2014 was reconstructed in 2015 and she could have a symmetrical face; and vestibular condition from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was asking for accommodations Pfizer would provide to advocate for people working from home to minimize their risk of exposure to COVID-19. The patient was a teacher, who taught languages and she often had students with hearing disabilities and had to take her mask down so they could see her lips. She reported that she was fully vaccinated but was concerned about being exposed to people who haven't been vaccinated and asked if there were any recommendations or accommodations being offered by Pfizer to assist her with trying to work from home. The patient received her second vaccine dose on 02Apr2021 at 10:30 AM with lot number: ep7533. The patient reported experiencing Bells Palsy after being vaccinated on an unspecified date in Mar2021 and was asking how long or much protection she had against COVID-19, because her understanding was that because she reacted to the vaccine in this way, if she got COVID-19, she might experience the same type of reaction to COVID-19 and she didn't want to experience Bells Palsy again. The patient reported that she had "distinct reactions" to both the first and second doses and was told by her neurologist that because its a live virus and she had a reaction to it, she had the potential to get the same symptoms from COVID-19. The patient further asked if the Pfizer-BioNTech COVID-19 vaccine could shed the virus and was provided with references. Upon follow up, the patient stated that she was one of those people who had an allergic reaction to Pfizer, she had both doses. The patient stated she thought she was better off vaccinated. After the first dose, she did have the characteristic symptoms and people thought she was having a stroke; she was fine, but it freaked out her husband. She stated she should know as she has had facial reconstruction and did have it in the left arm. The patient got vaccinated at a clinic in a neighboring area and called her primary care doctor. The patient stated her blood pressure went up to normal on an unspecified date in Mar2021, which was not normal for her, as its very low. She stated she had the characteristic dizziness, headaches, tingly feelings, and Bells palsy on an unspecified date in Mar2021. She stated her primary care doctor asked her where she got the shot, she said in her left arm and it was swollen on an unspecified date in Mar2021. The patient stated she did go to the emergency room, which was scary. She stated she spent a year and a half trying to stay away and stated everybody got to see her at her baseline, which was a semi-symmetrical face. The patient stated after a while, the doctor said yes the patient might want to consider getting the second dose. The patient stated that because of the brain surgery, she was able to quickly write an email to many doctors who could weigh in. The patient stated that the doctor said the benefits outweighed the risk, but the other recommendation, which was brilliant, they said to get it in her leg. The patient stated she did have an allergic reaction to the second one, but not the same way and stated it was the characteristic tiredness on an unspecified date. The patient stated her husband got Moderna and was out a whole day. The patient also stated she had the slurring of speech, the face, and it took a couple of days to go away, but it did and then she was back to her as-symmetrical face as she could have. The patient stated the second time though she went a week and a half later, she thought it was too much zoom fatigue, but the doctor said it sounded like annular fissures. The doctor then asked if she did get her vaccine and she told the doctor she did. The patient didn't know if that's a thing; she thought she would bring that up, because her back became inflamed. The patient further stated that for the first dose, her face got swollen and definitely impacted her speech, which promoted her to go to the emergency room. She stated she felt dizziness, headaches, she knew what to expect, but she got worried when she was getting a little bit more droopier than usual. The patient stated that for the second time (dose), it took about 12 weeks to recover and she had been able to recover; she stated her back was inflamed and fortunately, there was no slipped disc or bulging discs, it was just annular fissures. The patient stated that a doctor in the area said that it made sense; it was locally the right thigh (second dose) - lower back, left arm (first dose) - left side of the face, and its kind of thematically and spatially related. The patient stated she got this at the hospital way back in Mar2021. The patient stated they did a brain magnetic resonance imaging (MRI), computerized axial tomography (CAT) scan, and diabetes test. The patient stated that to live the pandemic, she was worried that she had eaten too many cookies, but everything came back normal, as normal for her. She stated clearly she had got issues, but they were issues long before the vaccine. The patient was one of those people who definitely had something happening and people were saying no that can't be. She stated it was evident that yes, it was Bells palsy, she had never had. She stated she had had facial paralysis that was taken care of by Gracilis surgery. She stated it was experimental when she did it, but it's not so experimental anymore after her brain surgery. The patient stated Pfizer might want to hear her happy ending. The patient stated her daughter got Pfizer a few weeks prior reporting, so she's fully vaccinated and they had their first hug since 2020 and it was just an emotional thing. The patient stated she followed up with a neurologist and she was going to see him in the middle of June, she sees him every couple of months, mostly for work accommodations. The patient stated that the idea being if Bell's plays was her reaction from a dead form of the virus, even getting sick with it would indicate that this could happen to her in a different context. She stated that since she's a teacher, it's a good thing for her to know as she went back to work, she'd been able to work online, she'd probably not going to be able to argue for that unless her doctor argued for her. She stated her neurologist would know more of the story. She stated she saw her primary care doctor for her annual physical after she was fully vaccinated. She stated the follow-up was with a neurologist. The patient further stated she was fine and was not fine at the time of the reported events, but it was better to get the vaccine than to get COVID-19. She stated her mother and sister were all vaccinated. The patient further stated that on her 1st dose, she felt like someone had taken a hammer to her head and was headachy and not feeling great and was taken to room to wait; stated her blood pressure was taken and it was 120/70, which was normal, but not great for her and was high for her as she normally had a very low blood pressure. She went home and might be an hour after getting home, she realized her face was swelling and got the 1st dose of the vaccine to the left side of her upper arm and her face started to swell and she did have brain surgery in 2014 and stated in 2015, she had Gracilis free flap of her right thigh and had a new cheek and had calf nerves grow back together again and had to learn to walk again at that time, because they spliced the nerves, which was not a transplant but a transfer. The patient stated the flap made her face back symmetrical as possible and used her face and able to drink coffee, smile and keep food in her mouth; stated her face kind of drooped anyway, but this was more than that. The patient stated her husband said she had been traumatized and just to relax and she kind of got Bell's Palsy, which she had never had before and got diagnosed with it and was swollen and started having slurred speech; stated she had facial droop and got to the hospital, which was emotional and getting the Pfizer COVID vaccine was emotional and she was trying not to add to her issues. The patient stated was able to see formal field and everyone thought she was having a stroke, but she was not having a stroke and everybody said it couldn't be the Pfizer vaccine; it had to be something else. The patient stated her healthcare professional (HCP) asked about her baseline and her husband had photos of her and she was not normally symmetrical in her face. They did scans, MRI brain and everything checked out normal, which was a blessing and several HCPs were getting results and she did not have diabetes. The patient stated she was trying to be careful during the pandemic with her health and they kept her in the emergency room from 11-12 pm to 8:00 pm and she was saying she was hungry and thirsty and did not know they did not want her to eat or drink and wanted to make sure she could swallow and she was ok swallowing, but had dribble on the left side of her face with the drooping. She stated she saw her primary HCP before she went to the emergency room and he asked which side she got the Pfizer COVID vaccine on and that was kind of where he had the idea that this could be related to the vaccine and the reported events occurred so close to when the vaccine was administered and the reported events occurred immediately after the vaccine; she stated her blood pressure was ok and she ate a cookie and maybe had not enough breakfast and got worse. The patient stated her slurred speech and Bell's palsy lasted a day or two and everything went back to normal, stated because she had brain surgery, which saved her life; the HCP said maybe she should rethink going for the 2nd dose of the Pfizer COVID Vaccine; she followed-up with her neurologist and everybody weighed in the benefits outweigh the risk and she got the 2nd dose. She did the 2nd dose of the Pfizer COVID Vaccine in her right thigh and had inflammation in her lower spine after that; stated how the shot felt like a shot in the arm or a horse kicked you; stated she felt like the Pfizer COVID vaccine felt like a shot in the arm, but never felt that pain and had swelling and had a half an apple sized swelling in her leg for a couple of days; stated she also did not feel the face drooping, because the 2nd dose of the vaccine was done in her leg. With the second dose, she started to get really bad lower back pain and went to the HCP and was maybe sitting down too much; stated she did not have proper posture sometimes and did not want to stand. She stated she saw a holistic HCP, which was a chiropractor and that HCP did not touch her spine; stated she saw that HCP on 14Apr2021 and she was diagnosed with annular fissures and they thought she had a slipped bulging disc and never had that before, but had a tingling sensation and they said to take a few weeks to recover. She stated she kept seeing her HCP and had recovered and had to say as soon as they said this was probably related, because she thought the Pfizer COVID vaccine targeted places that were weak and that was the weak part in her body regarding her spine; stated her left side arm was weak and the weak side of her face that was where the transfer of nerves was and that had gotten swollen and did not work. She stated she was fine and would say she was better and thought she was completely recovered and from time to time still just felt a little tingling still and did not have that before; stated because of her brain surgery, the neurologist said she could tingle independently and she did not normally tingle in that area, but she was better and 90 percent better; stated the HCP said to give 12 weeks to recover and she would see her again next week and would see the HCP every 2-3 weeks so this; said they needed the discs to get fluid in them so they were healing; stated her daughter got the Pfizer COVID Vaccine and is doing well. The patient underwent further lab tests and procedures, which included Brain MRI, CAT scans, and diabetes test, which were all normal on an unspecified date. The patient was recovering from the event "tingly feelings/still just felt a little tingling still," while she recovered from the rest of the events on an unspecified date.
53 2021-06-10 anaphylactic reaction anaphylaxis; new allergic reactions to items which was never allergic to before: nuts, sea food, hai... Read more
anaphylaxis; new allergic reactions to items which was never allergic to before: nuts, sea food, hair color; new allergic reactions to items which was never allergic to before: nuts, sea food, hair color; period on already menopause over one year; This is a spontaneous report from contactable reporting for herself. This 53-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02May2021 at 13:15 (at 53 years of age), in left arm, for immunization. The first dose of BNT162B2 vaccine was administered on an unknown date and she experienced hives. Medical history included COVID, allergy to Aspirin, ibuprofen and MIT/CIT/BIT and menopause. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02May2021 at 14:30 the patient experienced anaphylaxis. A couple of days to weeks later, on an unspecified date in 2021, triggered several new allergic reactions to items which was never allergic to before: nuts, sea food, hair color; also triggered, after 2 weeks of the shot, period on already menopause over one year. At hospital anti-histaminic and anti-inflammatory treatment was administered. The events required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The events were reported serious as life-threatening and medically significant and had not yet resolved. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021642412 same reporter/patient/product, different dose/event.
53 2021-06-10 lymph node swelling, lymph node pain lymph nodes in her legs were swollen; lymph nodes in her legs were painful; severe gluten allergy; s... Read more
lymph nodes in her legs were swollen; lymph nodes in her legs were painful; severe gluten allergy; staff tried 5 to 6 times in both arms trying to get blood; difficulty breathing/couldn't breathe; a herpes outbreak on her buttocks/herpes simplex outbreak/7 quarter size areas on her left butt and down her left leg; a rash completely covering her hands, head and ears; hand were itching/head was itching/ears were itching; loses 3-4 lbs after each episode and has lost a total of 12 pounds; an upset stomach; four other allergy attacks/ allergic reaction during a barbeque; urticaria/ a rash from the bottom of her breasts to her nose; lip swelling; This is a spontaneous report from a contactable consumer (patient). This 53-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727; Expiration Date: 31Jul2021), via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 53-year-old) as single dose for COVID-19 immunization. The patient provided the following for her medical history described: As a teenager, she was very allergic to everything- foods, vegetables, apples, tomatoes, avocado, raw almonds and pollen: Her throat would swell, and her face would swell up but would take cortisone and it would be good the next day. After her pregnancies, her allergies subsided and were well managed for 15 years. In the past, she was taking RECTODELT for her allergies to food and normally it would help with that. It worked quick, within 15 minutes. She also has ongoing herpes simplex and sometimes it's on her butt. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for hypersensitivity, start and stop date were not reported; dexamethasone (manufacturer unknown) taken for malaise; naproxen (manufacturer unknown) taken for pain; naproxen sodium (ALEVE) taken for an unspecified indication. The patient previously received Flu vaccination in Aug2020. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205; Expiration Date: 30Jun2021), via an unspecified route of administration in the right arm on 27Feb2021 (at the age of 53-year-old) as single dose for COVID-19 immunization. The patient reported that she received her second Covid-19 vaccine on 20Mar2021, and she didn't have a reaction right away. On 04May2021 she had an allergic reaction completely different than what she's used to. She explained that she had a BBQ (barbeque) and she ate vegetables and had half a glass of rose wine, and she went to bed around 11:00PM on 04May2021. On 04May2021 at night she woke up in the middle of the night with difficulty breathing, an upset stomach, and a rash completely covering her hands, head and ears. On 04May2021, she took some cortisone, RECTODELT, a 100mg prednisone suppository, but it didn't help. She has a doctor friend who had given her some medications. Her doctor friend had given her an antihistamine liquid, CELESTAMINE N 30ml, and a cortisone liquid, SENISTIO 20ml, and those two medications combined helped her symptoms. The next day it was better. On 06May2021 she couldn't breathe so her doctor friend told her to go to the emergency department (ED) so she went to the emergency room on 06May2021 in the middle of the night. She also did have an outbreak when she went to the emergency room. She had it so very bad. She had about 7 quarter size areas on her left butt and down her left leg and the lymph nodes in her legs were swollen and painful. The emergency room checked her blood pressure and it was fine, they checked her oxygen level and that was fine, they did an EKG and that was ok, and they did blood work and that was ok too. In the emergency department, she did have an IV and they gave her Cortisone in her IV. She had the IV in her right arm and when she received the Cortisone her arm was getting warm and then she felt flushed through her whole body. It was really strange, and she was super scared. Also while she was in the emergency room, the emergency room staff tried 5 to 6 times in both arms trying to get blood and he tried to go in her lower arm and she finally asked that someone else try to get blood. They discharged her and told her to follow up with her primary care physician (PCP) and an allergy doctor. Since 04May2021, she has had four other allergy attacks. She loses 3-4 lbs after each episode and has lost a total of 12 pounds. She reported she saw her primary care doctor on 18May2021 and received a prescription for steroids for a herpes outbreak on her buttocks and went down her legs. During her doctor visit on 18May2021, she had allergy testing done: She is allergic to almost everything, and she can only eat chicken and rice because she now has a severe gluten allergy. She was told to take 2 Allegra per day for 10 days and was given 1mg dexamethasone to take if she feels really bad. When she saw her family doctor, her doctor asked her if she had been in a fight because her arms looked so bad from all the needle sticks trying to get blood. It was very painful. She doesn't think the allergic reaction was related to the emergency room staff not being able to get blood from her. And she does drink a lot so she doesn't get dehydrated. She had some allergy tests and those came back that she's allergic to almost everything. The doctor also prescribed Valacyclovir HCl 1gm tablet for the herpes simplex. Her doctor told her to take it for another week and then stop taking it and then start again if she has another outbreak. The Acyclovir she was taking wasn't working. It was Acyclovir 800mg in a pharmacy bottle (Discard by date: 14Aug2021). Her gynecologist gave her Naproxen to take for pain. She does a lot of yoga and when her joints are hurting she takes Aleve. She did take Aleve on the day of her first Covid 19 vaccine and she drank a lot of water and a lot of Gatorade. The patient reported that the itchy head, hands, and ears happened 3 or 4 more times. She's thinking this could be related to the Covid-19 vaccine, that the Covid-19 vaccine triggered her allergies. This past Monday/Tuesday (May2021) she had her most recent allergic attack (she is not sure if it was from eating potato chips or just taking one Allegra that day), she had difficulty breathing, lip swelling, urticaria/ a rash from the bottom of her breasts to her nose. She had an EpiPen nearby and she took an 100mg suppository of prednisone. Her doctor told her to take 2 Allegras everyday indefinitely. She is feeling better today and was able to go to a yoga class- but still has the rash. She saw her PCP yesterday (25May2021) and got a prescription for valacyclovir, she is to take it for 7 days and then start again if it flares up again. She is getting an inhaler today for if she has difficulty breathing again due to an allergic reaction. Her doctor thinks this may all be caused by a histamine intolerance from the shot, her other HCPs do not believe its vaccine related. Her doctor also said that it could be due to a bad mosquito bite that she got two weeks before her first allergic reaction or due to a teeth whitening procedure that she had issues that she also received before the allergic reactions started. The clinical outcome of the events " urticaria/ a rash from the bottom of her breasts to her nose" was not resolved, and the outcome of the events, difficulty breathing/couldn't breathe, "a herpes outbreak on her buttocks/herpes simplex outbreak/7 quarter size areas on her left butt and down her left leg", "four other allergy attacks/ allergic reaction during a barbeque", an upset stomach, "a rash completely covering her hands, head and ears", loses 3-4 lbs after each episode and has lost a total of 12 pounds, lip swelling, hand were itching/head was itching/ears were itching, lymph nodes in her legs were swollen, lymph nodes in her legs were painful, severe gluten allergy and "staff tried 5 to 6 times in both arms trying to get blood" were unknown.
53 2021-06-11 swelling face severe shingles on the right upper face. Right eye and right face was swollen. Visited ER room, alm... Read more
severe shingles on the right upper face. Right eye and right face was swollen. Visited ER room, almost hospitalized. Crack was detected on the cornea. 1) Anti-inflammatory, antiviral and antibiotic medicine were given to the first 10 days at the maximum doses each day. 2) Blisters were crusted after 2 weeks 3) severe nerve pain after the rash was gone. 4) Lyrica was prescribed but didn't show much effect in reducing the pain.
53 2021-06-12 lymph node swelling "Pfizer-BioNTech COVID-19 Vaccine EUA. I had injection site pain (right arm), tiredness, headache,... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA. I had injection site pain (right arm), tiredness, headache, muscle pain, chills, joint pain, fever of 100.2, nausea, swelling of lymph nodes in my right armpit area. I spent the whole day and night in bed. I had the fever for most of day, but when I woke up the following morning 6/13/21 the fever was gone and I was feeling much better. I am still a little sore and tired but I feel like I can get up and get through the rest of my day.
53 2021-06-13 white blood cell count increased, sepsis 53 yo woman with no PMH was diagnosed with COVID-19 by PCR on 5/7/21. She had a mild illness with co... Read more
53 yo woman with no PMH was diagnosed with COVID-19 by PCR on 5/7/21. She had a mild illness with cough and fevers but did not require hospitalization. Her symptoms lasted about 1 week. She got her first dose of Pfizer COVID vaccine on 5/29 around 11 am. Within 4 hours (around 3 pm) she started to develop extreme fatigue, which she attributed to vaccine. This was followed by nausea, vomiting and diarrhea later that same day. The symptoms got worse on 5/30. Her diarrhea/GI symptoms resolved on 5/31. That day, she had a fever to 101.3. She continued to have fatigue, and started to have dyspnea, and presented to hospital on 6/1/21. On arrival to ED her vitals were 88/41, 36.1, 125, 18, 95% on RA (13:22). She become more hypotensive with nadir BP 63/48, HR 109 at 17:30, at which time she was started on norepinephrine. Physical exam at admission was notable for clear lungs, tenderness to palpation in the midepigastric and LUQ areas, and the absence of rash. Admission labs: WBC 31.3, Hb 14.2, Hct 43.0, Plt 144, MCV 96, 85% neutrophils, BNP 3117, Na 132, K 3.8, CO2 19, Cl 95, BUN 35, Create 4.62, gluc 133, protein 6.1, alb 2.2, TB 5.5, DB 2.9, Alk phos 159, ALT 47, AST 33, lactate 4.2, troponin I 0.047, random cortisol 93. Strep pneumo and legionella antigens negative. Hepatitis serologies, HIV test, all negative. COVID test by PCR was positive on 6/1/21. She was admitted to the ICU. The day following admission (6/2) CRP 32.4, ESR 106, LDH 399, ferritin 1626, procalcitonin 54.85. CT A/P unremarkable except for bilateral patchy airspace opacities. RUQ US unremarkable, including Dopplers. Echocardiogram (TTE) with LV systolic function mod-severely globally reduced, EF 35%, no valvular disease. Dopplers of LE showed small non-occlusive thrombus in R common femoral. The patient was seen by Infectious Diseases on HD#2 (6/2/21) and IVIG was recommended and administered due to suspicion for MIS-A. She had also been started on cefepime, vancomycin and metronidazole on admission. Blood, urine and resp cultures were negative. She continued to have high norepinephrine requirements, reaching 0.34 mcg/kg/min on 6/3. Due to ongoing shock (cardiogenic vs septic), a Swan-Ganz was placed on 6/4/21. RAP 11 mmHg, RV 38/10 mmHg, PA 40/20 (27) mmHg, PCWP 19 mm Hg, CO 5.75, CI 2.8, SVR 1100, MvO2: 70%. These were consistent with distributive/septic shock rather than cardiogenic. The patient was able to be weaned from pressors on 6/5/21 at 11:55. Throughout her entire hospital stay, she was comfortable with no respiratory distress, and no abnormalities in mentation. She was transferred to the general medical floor and completed 7 days of antibiotics for empiric sepsis treatment. Labs at discharge on 6/8 showed procalcitonin 5.43, CRP 8.8, LDH 362, Ferritin 1511, TP 5.9, ALT 17, AST 29, Alk phs 158, TB 1.3, Alb 1.6, Create 0.98, WBC 32.5, Hb 7.8, Hct 22.9, Plt 100, neutrophils 70%. She was feeling well without complaints, and will follow up as an outpatient. She was prescribed Xarelto for DVT.
53 2021-06-16 lymph node pain, lymph node inflammation, lymph node swelling Patient presents to clinic with headache, body aches, rash, and enlarged, swollen and tender left su... Read more
Patient presents to clinic with headache, body aches, rash, and enlarged, swollen and tender left supraclavicular lymphadenitis.
53 2021-06-16 lymph node swelling, lymph node pain Chronic and severe all over body ache; Muscle aches; Swollen and painful joints; Swollen and painful... Read more
Chronic and severe all over body ache; Muscle aches; Swollen and painful joints; Swollen and painful joints; Headache; Fatigue; Back spasms; swollen/painful lymph nodes under both armpits; swollen/painful lymph nodes under both armpits; This is a spontaneous report from a contactable consumer (patient). A 53-Year old Female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EW0150, on 16Mar2011 11:00 at single dose in right arm (at the age of 53-year-old) for COVID-19 immunization. Medical history included Depression, Attention deficit hyperactivity disorder (ADHD), Hashimoto's disease, Fibromyalgia, Rheumatoid disease, and known allergies Latex. Concomitant medication included unspecified medication. The patient did not receive other vaccine in four weeks. The patient received Other medications in two weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. On 17Mar2021 12:00, the patient experienced Chronic and severe all over body ache, muscle aches, swollen and painful joints, headache, fatigue, back spasms and swollen/painful lymph nodes under both armpits. She had appointment with PCP for referral to rheumatologist 09May2021. All events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for events. Lab data included HLA-B27 gene positive. The outcome of all events was not resolved. Follow-up actions are needed. Further information has been requested.
53 2021-06-17 lymph node swelling woke up the next day feeling sick and it got worse; She said that she got sick after taking the firs... Read more
woke up the next day feeling sick and it got worse; She said that she got sick after taking the first dose to the point that she was going to the hospital; body aches; Fever; Headache; had lymph node swelling; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for herself that the 53-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE) at the age of 53-year-old, dose 1 via an unspecified route of administration, administered in Arm Left on 27May2021 14:00 (Batch/Lot Number: EW0185) as 1st dose, single for covid-19 immunisation. Medical history included covid-19 from Dec2020 to an unknown date. Family Medical History was none. Concomitant medications included ongoing probiotic and Multivitamin and she explains she doesn't really take medication, only supplements like a probiotic and a multivitamin. The patient experienced she said that she got sick after taking the first dose to the point that she was going to the hospital (illness) (hospitalization) on 28May2021 with outcome of recovered , had lymph node swelling on an unspecified date with outcome of unknown, body aches on 28May2021 with outcome of recovered, fever on 28May2021 with outcome of recovered, headache on 28May2021 with outcome of recovered, woke up the next day feeling sick and it got worse on 28May2021 10:00 with outcome of recovered. The patient underwent lab tests and procedures which included body temperature: 103.6 on unknown date (Her fever was 103.6, this was the highest), body temperature: 101.8 on unknown date (It would go down to 101.8), body temperature: 102.5 on unknown date (she still had 102.5, would not drop), body temperature: 103.2 on unknown date (It was at 103.2 and it wouldn't drop, that is when she showered). Therapeutic measures were taken as a result of she said that she got sick after taking the first dose to the point that she was going to the hospital, body aches, fever, headache. Consumer wanted to know the coverage of protection after one dose of the Pfizer OCVID-19 vaccine. She also would like to verify if the first dose primes the immune system, helping it recognize the virus and if the second dose boosts the immune system. Consumer (53-yr old female) has taken the first dose of the Pfizer COVID-19 vaccine. She said that she got sick after taking the first dose to the point that she was going to the hospital. She also mentioned that she had lymph node swelling that lasted for about a week. She wanted to know if the adverse events with the second dose of the vaccine are grater than those of the first dose's. Consumer mentioned that she had COVID-19 infection back in Dec2020. She wanted to know if having COVID-19 would increase her immunity and would it act as the first dose of vaccination. "The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19." Caller wanted to know if she could only take one dose of the vaccine. Consumer also mentioned that she had lymph node swelling that occurred for about a week. Warm transfer of a caller reporting that she came down with COVID in Dec2020. On 27May2021 she got her first dose and after the dose she became so sick, worse than when she had COVID. It was too the point that her husband almost took her to the hospital. She explains she has read articles about the first dose, and how it is getting a person ready for the second. That the second dose is supposed to be a lot harder that the first dose. The caller wonders if she should take the second dose. Consumer reports that she wants the coverage from the vaccines and to be protected but at the cost of what she went through with the first dose, she is scared to take the second dose. The events started the following day, after the vaccine. She got the vaccine at 2pm then woke up the next day feeling sick and it got worse. The events lasted about a day and a half with the worst part being from about 10am on 28May2021 until about 7am on 29May2021. When talking about the sick feeling the caller explains she still had body aches till about 5pm on the 29May2021 but they were not as severe, which is what she had expected. Treatment: The following day on 28May2021 in the morning she took 400mg of Ibuprofen which was 2 of them, and they did not help. UPC: 8113107845, Lot: The first digit is a 0 or O followed by AE3334A, Expiry: Nov2021. Then she took 2 Excedrin mid-day and that didn't help. UPC: 8113136703, Lot: WJ1984 followed by a G or 6, Expiry: Aug2022. Then that evening she took 1000mg Tylenol which she later clarified as Equate pain reliever pain extra and that didn't help much. UPC: 8113111254, Lot: 0KV1625, Expiry: Aug2022. Her fever was 103.6, this was the highest. She also took cool showers to control the fever and this would help a little for about 30 minutes. It would go down to 101.8. At midnight, she took another 1000mg of the Equate pain reliever and 2 hours later she still had 102.5, would not drop. The body aches were terrible. She also had a headache and that was mild. It was the body aches that were unbearable, she could hardly walk they were so severe, and the fever. It was at 103.2 and it wouldn't drop, that is when she showered. She felt so sick, she couldn't move. The caller explains she has never been that sick, even with the flu. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none.
53 2021-06-18 lymph node swelling, lymph node pain Hot, swollen, painful lymph nodes, temp 100.1F, pain of ovaries
53 2021-06-18 peripheral swelling COVID arm. Intense swelling and pain on most of upper arm
53 2021-06-20 lymph node swelling, sepsis Pt. presents to ER on 06/02/2021 stating "has not felt right for a long time". Pt. is not sure how l... Read more
Pt. presents to ER on 06/02/2021 stating "has not felt right for a long time". Pt. is not sure how long of time that she has not felt right. Pt. reports this am going to the refrigerator and was not able to grasp a pop. Pt. reports having right hand weakness that started this am. Pt. reports not being able to grasp her phone either due to the right hand weakness. Pt. was found to have an initial temp of 100.4 which spiked to 103.1, HR tachy at 126, BP 108/71, O2 sat on RA 98% and respirations 18. Pt. received and IV lock, fluids, CXR, EKG and CT of ABD and pelvis for c/o abd pain/discomfort and Lab were obtained. Pt. received Rocephin 1 gm IV and Zosyn 3.375 gm IV times 1 dose of each in ED. Pt. was transferred to Hospital in another area for diagnosis of sepsis and fever of unknown origin for higher level of care.
53 2021-06-22 anaphylactic reaction, peripheral swelling not getting rid of a huge red it's 2 inch red circle around the injection area; abnormal EKG; could... Read more
not getting rid of a huge red it's 2 inch red circle around the injection area; abnormal EKG; couldn't breath/shortness of breath; like an anaphylaxis reaction; chest pain; she was coughing a lot; having a flare up of asthma; rash started getting red and bumps started/bumps moved down her left arm; bumps on her left arm; skin colored bumps; developed a Covid rash/rash; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose via an unspecified route of administration, administered in Deltoid Left on 08Jun2021 17:30 (Lot number was not reported) at age of 53 years old as a single dose for covid-19 immunisation. Medical history included asthma from 2014 and ongoing, hypothyroid, allergy to cat, cipro. The patient had no Family Medical History Relevant to events. Concomitant medication included levothyroxine taken for hypothyroidism from an unspecified start date and ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration on 21May2021 (Lot number was not reported) at age of 53 years old as a single dose for covid-19 immunisation and No reaction on previous exposure to vaccine. The patient experienced couldn't breath/shortness of breath (medically significant, life threatening) on 13Jun2021, like an anaphylaxis reaction (medically significant, life threatening) on 13Jun2021, developed a covid rash/rash (medically significant) on 08Jun2021, chest pain (medically significant) on 13Jun2021, rash started getting red and bumps started/bumps moved down her left arm (medically significant) on 10Jun2021, bumps on her left arm (medically significant) on 10Jun2021, abnormal ekg (medically significant) on 13Jun2021, she was coughing a lot (medically significant) on 12Jun2021, having a flare up of asthma (medically significant) on 12Jun2021, not getting rid of a huge red it's 2 inch red circle around the injection area on 14Jun2021, skin colored bumps on 09Jun2021. The outcome of the event 'abnormal ekg, having a flare up of asthma, skin colored bumps', all was unknown, 'she was coughing a lot and like an anaphylaxis reaction' was resolving, and the other events was not recovered. The patient underwent lab tests and procedures which included chest x-ray: Negative, electrocardiogram: abnormal, Flu Test: negative, metabolic function test and Labs, Cardiac Workup: all unknown results, COVID test: negative, all on 13Jun2021. The patient went to Emergency Room on 13Jun2021. She is on her way out of town, but she just moved to that area, so she will be seeing her doctor tomorrow for follow up from the ER. Prior Vaccinations (within 4 weeks) was None. AE(s) following prior vaccinations was none. Events 'bumps on her left arm, not on the deltoid area, but in front of her deltoid, in the bicep area were 15 raised bumps that were the same color as her skin; developed a Covid rash', 'bumps moved down her left arm', 'bumps went down her other arm, right arm and fully covered it and the bumps became bumps on top of bumps and were turning red', 'couldn't breath and dyspnea; like an anaphylactic reaction', ' Red Circle Around Injection Site Related', 'Abnormal EKG', 'Chest Pain on the right side, a little stabbing pain' were reported as related to suspect vaccine. Clinical course: After 2nd dose of Pfizer covid vaccine on 08Jun, caller experience rash that got worse 1st and 2 day and by the 4th day had shortness of breath, chest pain and like an anaphylaxis reaction, went to ER, was put on IV Decadron, prednisone, and Benadryl. Is still taking prednisone and Benadryl, looking to see if any data on 4 or 5 day effect from this? once she goes off the prednisone and Benadryl her symptoms come back. Still taking medications , when time for next dose, her symptoms start to come back. Once someone has taken medication , what is data on medication and recovery for these side effects? she was concerned, she read up on Adverse reactions and long term effects, she had no problem with first shot., She know second shot you can have problems, when rash started gets stating red and bumprted and 3 days later woke up and couldn't breath, took Benadryl and her in halers and it startled her again in the middle of the night where she needed to get to the ER. She had an abnormal EKG to follow up on and some chest pain. She was concerned because it's the vaccination. She had read the cardiac situation, she read it all. She read about the covid rash, but it turned into something else, now where they gave the injection, the prednisone and Benadryl not getting rid of a huge red it's 2 inch red circle around the injection area, this came up yesterday, not sure if it's because she got the other injection in her arm. When she got her second covid shot, all the symptoms that were described to you and the other agent was reported, this event didn't get written down where this red ring that just came up after the 2nd covid shot. She was currently having, on prednisone tapered dose 60mg on 2nd dose, When She waited to take it at 10, she had a hard time breathing, it was wearing off. Caller states she is a nurse as well. Caller states she is going to write this up of course. Caller states she got her first vaccine and it seemed to go well and then she got the second vaccine and apparently from the literature she was reading, she developed a Covid rash. Caller states on the second day after the vaccine, she had bumps on her left arm, not on the deltoid area, but in front of her deltoid, in the bicep area were 15 raised bumps that were the same color as her skin. Caller states she thought all was fine, she saw this was a common effect. Caller states the day after that, the bumps moved down her arm and she thought no problem, she wasn't concerned, she could breath and was fine. Caller states she called the pharmacy and they said she doesn't need to be worried, patients get bumps some times, so she said okay fine. Caller states the next day, so the 3rd day after, the bumps went down her other arm. Caller states on the 4th day after, she was coughing a lot. Caller states she has asthma and used her inhaler. Caller states she was going to the gym, and said oh, this is getting worse, so she took half of a Benadryl. Caller states she went to meet her daughter for dinner and it was getting worse, so she took the other half, and it seemed to help. Caller states she woke up at 02:00a.m. and she couldn't breath. Caller states the ER is 4 miles away, and when she got there they gave her IV Decadron. Caller states she had an abnormal EKG and dyspnea. Caller states she is now on a tapered dose of prednisone and Benadryl 2-3 times a day. Caller states now she has a big red lump on her arm, even with the medicine, the big red lump is probably 1-2 inches in circumference around the injection site. Caller states she is looking for any data as far as this 4-5 day effect she had or if there are any long term effects from this? Caller states she needs to ease her mind, once she is out of the prednisone and Benadryl, is she going to be alright? Caller states she wants to find out if there are any other reports like this. Caller clarifies the first day after, on her left deltoid muscle, she got risen skin colored bumps. Then the second day after, the bumps went down her left arm. Then on the third day, the bumps went down her other arm and fully covered it and the bumps became bumps on top of bumps and were turning red. Caller states on the fourth day after, when she went to the gym on the 12Jun2021, that evening she thought she was having a flare up of asthma and she was ignoring the bumps because she looked up the Covid rash thing and then started having problems breathing and on 13Jun2021 she went to the ER for like an anaphylactic reaction and cardiac workup. Caller states she still has a red circle around the injection site that has worsened, like where the medication was injected. Caller states the Prednisone and Benadryl aren't helping it. Benadryl: UPC, Lot, Expiration Unknown, states it is ordered every 4-6 hours 50mg. Prednisone: NDC, Lot, Expiration Unknown. States it is a tapered dose 60mg x 2 days, 40mg next 2 days and then 20 mg for the following 2 days and she wants to say it is at least 6-8 days of prednisone. Caller states she also had chest pain on the right side and she is still having it on the right side area, it is a little stabbing pain. Caller states her side effects prodromal effect, they came in stages and built on one another. Caller states her symptoms are persisting, if she doesn't take the prednisone dose, when it is time to take medicine. Caller states when she woke up, she tried to wait as long as she could and the side effects started up again and she couldn't breathe good, states she took it around 10:00am. Treatment: Caller states she has Asthma and took her Inhalers Dulera 100mcg/5mcg and Albuterol, Benadryl, Prednisone, IV Decadron, Breathing Treatments. Caller states she went to the ER at 3:25a.m. on the morning of 13Jun2021 and they observed her for a while in the ER. Suspect product: First vaccine dose received on 21May2021, LOT:UNKNOWN. Second vaccine received on 8Jun2021, LOT: Unknown. Caller states they were given at the drug store given directly on time. Caller states when the SARS 1 vaccine came out, she was working in the ER and he got the vaccine for that but was fine. The patient had not receive any recent vaccines for any other conditions prior to the event being reported. The patient had not received any recent vaccines for SARS-CoV2 other than PfizerBioNTech COVID-19 Vaccine prior to the event being reported. The patient had not received any other vaccines around the time of PfizerBioNTech COVID-19 Vaccine vaccination. The patient was not hospitalized. The patient require medical intervention included Adrenaline; Corticosteroids; Antihistamine; IV fluids;Oxygen; Bronchodilators; Other Details: ER 13Jun2021. IV Decadron, Benadryl, Breathing Treatments, Prednisone. Organ involvement Multiorgan involvement included below Respiratory; Cardiovascular; Dermatological Respiratory Unknown. The event require the initiation of new medication included Benadryl and Prednisone, Z Pack. Caller stated she still has a red circle around the injection site that has worsened, like where the medication was injected. Caller states the Prednisone and Benadryl aren't helping it. Benadryl: UPC, Lot, Expiration Unknown, states it is ordered every 4-6 hours 50mg. Prednisone: NDC, Lot, Expiration Unknown. States it is a tapered dose 60mg x 2 days, 40mg next 2 days and then 20 mg for the following 2 days and she wants to say it is at least 6-8 days of prednisone. Follow-up attempts are needed; information about lot/batch number has been requested.; Sender's Comments: based on available information, the events were considered related to suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).
53 2021-06-23 peripheral swelling severe pain in vaccinated arm requiring evaluation by health care professional, arm is swollen, no l... Read more
severe pain in vaccinated arm requiring evaluation by health care professional, arm is swollen, no lymphadenopathy, no sign of infection, Rx provided for meloxicam
53 2021-06-24 peripheral swelling, lymph node swelling arm became sore; it feels like a little pain; under my arm pretty swollen where I had took this shot... Read more
arm became sore; it feels like a little pain; under my arm pretty swollen where I had took this shot; its swollen and it's very irritating and little painful; I felt like little pain under my armpit; I saw that it was real swollen under my armpit on the left hand side I took a shot at; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old female patient received BNT162B2(CONMITARY, Solution of injection, Lot Number: ER8729; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in Arm Left on 09Jun2021 (at the age of 53-years-old), as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm became sore, it feels like a little pain, under my arm pretty swollen where she had took this shot, its swollen and it's very irritating and little painful, she felt like little pain under my armpit, the patient saw that it was real swollen under my armpit on the left hand side she took a shot at on an unspecified date. Therapeutic measures were taken as a result of arm became sore, it feels like a little pain, under my arm pretty swollen where she had took this shot, its swollen and it's very irritating and little painful, she felt like little pain under my armpit, she saw that it was real swollen under my armpit on the left hand side she took a shot at. The outcome of the events was unknown. Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021695222 Same reporter/ drug, different AE/ patient
53 2021-06-24 peripheral swelling Arm became sore; it feels like a little pain,I felt like little pain under my armpit; Under my arm p... Read more
Arm became sore; it feels like a little pain,I felt like little pain under my armpit; Under my arm pretty swollen where I had took this shot,its swollen and it's very irritating and little painful; This is a spontaneous report received from a contactable consumer (patient) or other non-health care professional. A 53-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8729, Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 09Jun2021 (at the age of 53-years-old) as 1st dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. it was unknown that patient was pregnant. On 09Jun2021 patient experienced Arm became sore, it feels like a little pain, I felt like little pain under my armpit, under my arm pretty swollen where I had took this shot, its swollen and it's very irritating and little painful. Consumer stated, her son had a Doctor Appointment where she did a check-up, they did a check-up, so, we went to the clinic and now as they took his check-up, they asked him if he took the shot and want to take Pfizer shot, you know and he was like No, so, he could go ahead and take the Pfizer shot and I said what he taking it, I am taking also, I am also 53 years old so that is my first shot and his first time taken this shot also he could get back to his school so the nurse told us when we got home to take Tylenol so we both took a Tylenol. On 09Jun2021, later that night arm became sore so we both put alcohol on our arm, that was Wednesday so Yesterday I put alcohol on my arm it feels like a little pain, I felt like little pain under my armpit do you know later that night under my arm started hurt a little bit, I didn't know what it was, so the day she got up this morning and took a shower under my arm pretty swollen where she had took this shot under my arm today swollen you know that was, it was little painful. Consumer stated, mean basically right you know like I would never thought that, you know everybody got it shot and everybody got different side effects but it so happen I happened this side effect on my arm and its swollen and it was very irritating and little painful. Reporter state, it got expiration date 31Jul and on the back of the card they got the date that I go back, 30Jun. Other Medical Conditions: Consumer stated, she don't take no medications, she had took any prescription, she had been feeling Swollenness in her left arm since she took the shot and it was swollen and it was very irritating and little painful you know it was on my second, not her second, On her left side of the shoulder where she took the shot and rub an alcohol and took a Tylenol and she got painful later that night she pore some more alcohol on it, this arm was hurting and Irub alcohol on here, later that night when she was laying on the bed, she felt like little pain under her armpit on next morning she saw that it was real swollen under her armpit on the left hand side she took a shot at. Treatment was received for the event Arm became sore. The outcome of the events was reported as unknown. Follow-up attempts are needed. further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021695141 Same reporter/ drug, different AE/ patient
53 2021-06-26 lymph node swelling painful large swelling in armpit of side vaccine received.
53 2021-06-29 lymph node swelling This is a spontaneous report from a contactable consumer, the patient. A 52-year-old adult non-pregn... Read more
This is a spontaneous report from a contactable consumer, the patient. A 52-year-old adult non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8727) via an unspecified route of administration on left arm on 18Mar2021 at 07:00 as a single dose (at the age of 53-year-old) for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6205) via an unspecified route of administration on left arm on 28Feb2021 at 15:30 as a single dose for COVID-19 immunisation. The patient reported no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested positive for COVID-19. On 20Mar2021 at 12:00, the patient experienced swollen lymph nodes on injection arm and on 21Mar2021, the patient experienced lower back pain. No treatment was received for these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of swollen lymph node and lower back pain was recovered. No follow-up attempts are needed. No further information is expected.
53 2021-06-29 swelling face itchiness of face and upper boy(abdomen, back, arms, neck);; redness on the face; itchy throat; head... Read more
itchiness of face and upper boy(abdomen, back, arms, neck);; redness on the face; itchy throat; headache; swelling of the face (eyes,nose, lips); This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: EN6208), via an unspecified route of administration in the left arm on 21Mar2021 at 10:30 (at the age of 53-year-old) as single dose for COVID-19 immunisation. Medical history included sickle cell, fibromyalgia, asthma. The patient was allergic to sulfa drugs. The patient had not received any medications in two weeks prior vaccination. The patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021, the patient experienced minor itchiness of face and upper body (abdomen, back, arms, neck), slight redness on the face, itchy throat, headache and swelling of the face (eyes, nose, lips). The clinical outcome of the events itching, redness of face, itchy throat, headache and swelling of the face were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
53 2021-06-30 pancreatitis She was then admitted to the hospital for pancreatitis; She received the Pfizer Covid-19 Vaccine on ... Read more
She was then admitted to the hospital for pancreatitis; She received the Pfizer Covid-19 Vaccine on 25Feb2021 and her second dose on 12Mar2021; She received the Pfizer Covid-19 Vaccine on 25Feb2021 and her second dose on 12Mar2021; Clotting in systems/ Clotting in the liver and heart duct; All kinds of inflammation; She had gallstones or whatever; fogginess/has a foggy brain; sluggish; nap-y/wants to sleep all the time; Cough; lost taste and smell; lost taste and smell; 102 fever; aches and pains like a bad flu; aches and pains like a bad flu; she feels really tired/ she still has fatigue and like it is complete exhaustion; Chills; Nausea; Diarrhoea; She feels very slow; 1st dose 25th feb2021,second dose 12 march 2021; She contacted COVID-19 virus while in the hospital from her roommate; inflated in her belly; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer Sponsored Program COVAX US Support. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EN6206), via an unspecified route of administration, administered in left upper arm on 12Mar2021 at 11:30 as dose 2, single dose for COVID-19 immunization (at the age of 53-year-old). Medical history included Wegener's disease from 2019 and ongoing, immunocompromised and she has a rare autoimmune disease from an unknown date and unknown if ongoing. Concomitant medication(s) included rituximab abbs (RITUXIMAB ABBS) taken for Wegener's disease from Nov2019 to Jan2021. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: E69264) via unspecified route of administration, administered in left upper arm on 25Feb2021 at 11:30, as single dose for COVID-19 immunization. It was reported that on 12Mar2021 the patient received second dose of vaccine and on an unspecified date in Mar2021, the patient was admitted to the hospital for pancreatitis (hospitalization) and she contacted covid-19 virus while in the hospital from her roommate and experienced clotting in systems/clotting in the liver and heart duct, all kinds of inflammation, she had gallstones or whatever, fogginess/has a foggy brain, sluggish, nap-y/wants to sleep all the time, cough, lost taste and smell, 102 fever, aches and pains like a bad flu, she feels really tired/she still has fatigue and like it is complete exhaustion, chills, nausea, diarrhoea, she feels very slow and on an unspecified date in 2021 had inflated in her belly and reported that the patient received the first dose of vaccine on 25Feb2021 and her second dose on 12Mar2021. The reporter stated that four days after receiving her second dose of vaccine she was admitted to the hospital for pancreatitis where she contacted COVID-19 virus while in the hospital from her roommate and after that she came home from the hospital, she also tested positive for Covid which was a little soon to be fully vaccinated. Six to seven days into the second vaccine she was placed with a roommate. She added that she was negative, but it was festering in her and the hospital separated them immediately. She got home 8 days later and developed a cough and went to urgent care and was like, come on man. She also stated that it was 15Mar2021 or 16Mar2021, maybe 15Mar2021 and the 16Mar2021 she was admitted to the hospital. She was admitted for 8 days because of the pancreatitis and further stated that maybe it was 13 or 14, she does not know, she has Covid fog. She added that she came home and then went to urgent care on 15Mar2021. She stated that she needs to get on a trial, she was screwed, and she needs help. She was on Ritxumab which was a medication that counteracts the vaccine, and the FDA knows this and mentioned that it is on the list of some medications that are immunocompromising and does not work with the vaccine. Caller stated her rheumatologist has been trying to get her into trials. She further added that the Covid-19 rapid was negative, and the PCR was positive, and she did not have additional dates or details. The next day, she had a cough before the PCR test came back. She lost her taste and smell, she had 102 fever, no taste or smell, aches and pains like a bad flu. She stated that she took Mucinex which she takes when she gets a cough. It got rid of the cough, fever, aches, pains, and chills. The no taste, the no smell, and everything else. The diarrhea, the nausea, and all that other nonsense she had. She was sure she had protection from the vaccine. She had pancreatitis, a lot of clotting in systems and added that then she got pancreatitis again and they thought it was her gallbladder. She was not sure; they did more testing before this because she had a lot of clotting in systems. They did not know why, if it was from the vaccine doing wacky nonsense or clotting in her heart and all this other stuff. She stated that before surgery, her gallbladder was causing pancreatitis and they wanted future testing before her liver ruptured and all that crap. She was diagnosed with pancreatitis again before she could get all of the other tests done. Caller does not know specific dates of events. Three weeks after Covid, or maybe two weeks after Covid, it resolved itself maybe in Mar or end of Apr and May. Four weeks after or maybe 3 weeks after Covid, everything resolved. Nothing was wrong with her liver, and they took her gallbladder out. She also stated that all of the clotting was due to an infection and whatever, it was resolved itself. Clotting in the liver and heart duct. All kinds of inflammation were gone, and she was able to have surgery on her gallbladder and they took it out as she had gallstones or whatever. It was Jun whatever and she was still inflated in her belly. Caller states call handler does not need to know about that and provides no additional details. She also stated that after second vaccination she had fogginess, sluggish, and nappy and that after Covid, she just has a foggy brain thing whatever they call that the fogginess where you cannot remember things or form sentences. She feels very slow. A little big sluggish and like nap-y, like she was not a nap person, but she feels really tired. She stated she was just shutting off her phone alarm. She added that she still has fatigue and like it is complete exhaustion and she just wants to sleep all the time. Patient also mentioned that she had not taken Ritxumab from 3 months prior to being vaccinated and she had taken it in Jan, and she was supposed to take it every 6 months. It was a chemotherapy drug, but she took it in Jan, and nobody told her, and nobody knew that you should not take it at a certain time before getting vaccinated and nobody knows this, there were no alerts and it was nobody's fault, it was too soon, and no other information was known. Infusion centre people put her in a chair for 6 hours and stick the thing in her arm for the drip. She has to have every 6 months for at least three years. Caller states she has Wegener's disease since 2019, which was what this was for. The reporter was nervous with all of the clotting they thought it was clotting and it was from the infection and pancreatitis and nothing related to the vaccine. While she went for her second pancreatitis when she did that she got tested for antibodies and here was she now had Covid. She goes for her second round of Rituximab in July and they will run the test for B cells because that is the marker. Antibody B marker for any kind of resilience for Covid. Caller does not provide additional details. She also stated that she did not know what to take and stated if she takes Mucinex d as soon as she gets a cough or Advil cold and sinus or sinus and allergy if she gets stuffed up or itchy eyes and that is all she ever takes. The product complaint team provided the conclusion as 'The complaint for Lack of Effect with the product for the COVID-19 Vaccine was investigated. The investigation included review of manufacturing records, analytical results at the time of lot release, retained reference samples, deviations, and complaint lot history trends. The final scope was limited to include the reported finished goods lot EN6206, fill lot EN5339, the bulk formulated drug product lot EN5327. No returned complaint sample was received. All deviation investigations performed during the manufacturing process of the lot were reviewed. The conclusion of all investigations confirmed there was no quality issue which would affect the quality of the lot. No root cause or CAPA were identified as the complaint was not confirmed'. On Mar2021, the patient underwent lab tests and procedures which included antibody test which result showed tested negative for antibodies, culture performed which was positive and body temperature was 102 Fahrenheit and on 15Mar2021 the COVID-19 rapid showed negative and PCR test was positive. The event pancreatitis was considered serious (hospitalization) and for other events it was not specified. The outcome was unknown for the events of Inappropriate schedule of product administration, Off label use Feeling abnormal, Sluggishness, Somnolence, Cough, Depressed mood and patient was not recovered from the events of fatigue and abdominal discomfort and outcome of events pancreatitis, drug ineffective and covid-19 Coagulopathy, Inflammation, Cholelithiasis, Taste loss, Anosmia, Pyrexia, Pain, Influenza like illness, chills, nausea, Diarrheas was recovered in 2021. Information on Lot/Batch number was available. Additional information has been requested.
53 2021-07-01 swelling Patient stated being ok after 15 min observation time. She came back a few minutes later to the clin... Read more
Patient stated being ok after 15 min observation time. She came back a few minutes later to the clinic stating she felt a burning, numbing and swelling sensation near on her right neck/throat area. Her vitals were taken at 10:25am and read BP-140/84, HR-75, RR-18, O2 sat-98% at room air. She was given water and observed. she was talking and had no difficulty in drinking water, she had no complaint of having difficulty drinking. she stated it was feeling a bit better than when she first felt it. vitals were taken again in 10:45 and read BP-128/82, HR-70, RR-20, and O2 sat-97% at room air. Provider came in to exam patient and informed patient to monitor symptoms and if they got worse to return to clinic or go to hospital. Patient stated feeling better after being observed by the provider and was released home. Pt was contacted by phone at 4:17pm she stated the sensation and numbness had gone away and felt better.
53 2021-07-05 peripheral swelling I felt like I had blood clots; because of the buzzing feeling going through my body.; my arm hurt ve... Read more
I felt like I had blood clots; because of the buzzing feeling going through my body.; my arm hurt very bad; my tongue swelled up; I was extremely ill; I was suicidal for the first time in my life; 10 days after first shot my arm swelled up; This is a spontaneous report from a contactable consumer (patient reported for herself). A 53-year-old no-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on an unspecified date in Apr2021 at 12:00 (at the age of 53-year-old) as single for covid-19 immunisation. The patient medical history included asthma and osteoarthritis. The patient had no known allergies. Concomitant medications included Alprazolam (XANAX) and Fluticasone propionate (FLOVENT), all taken for an unspecified indication, start and stop date were not reported. The patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8734), via an unspecified route of administration, administered in Arm Left on an unspecified date in Apr2021 as single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient was not tested for COVID-19 since the vaccination. 06May2021 20:00,10 days after first shot, patient arm swelled up and later that night she was suicidal for the first time in her life and had to call for help. She stated that she had photos and video of a magnet sticking to her arm on 27May2021, 03Jun2021 and 17Jun2021. After 17Jun2021, In Jun2021, the patient arm hurt very bad, her tongue swelled up and she was extremely ill. She stated that she would never do it again. She felt like she had blood clots on 17Jun2021 because of the buzzing feeling going through my body. No treatment was received to treat the events. The reporter assessed the event as non serious. It was reported that the events were not resulted into the seriousness criteria of death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. The patient was resolved from all the events on an unspecified date in 2021.
53 2021-07-07 peripheral swelling Body aches, hands hurt felt swollen, muscles aches still.
53 2021-07-08 lymph node swelling Loss of appetite; Severe headache; Fever of 103.8; Left underarm lymph node swollen to the size of a... Read more
Loss of appetite; Severe headache; Fever of 103.8; Left underarm lymph node swollen to the size of an egg; Joint pain; Injection site swell up to the sizeof my hand; Very fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the left arm on 22Mar2021 at 13:00 (at the age of 53-years-old) as a single dose, for COVID-19 immunisation. Medical history included asthma, high blood pressure, osteoarthritis and overweight. Concomitant medications included tiotropium bromide monohydrate (SPIRIVA RESPIMAT), budesonide, formoterol fumarate (SYMBICORT), meloxicam (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN); all for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left arm on 02Mar2021 at 15:00 (at the age of 53-year-old) as a single dose, for COVID-19 immunisation. The patient had a history of allergy to tree nuts. The patient did not receive any other vaccine in four weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 04:15, within 24 hours the patient had fever of 103.8 (unspecified units), left underarm lymph node swollen to the size of an egg, severe headache, joint pain, injection site swollen up to the size of hand, loss of appetite and had very fatigue. The patient reported that after 48 hours, body temperature went down to 101.6 (unspecified units) everything else the same. It was reported that on day 3, the body temperature of the patient had reduced to 100.5, appetite came back, still had some fatigue, joint pain reduced, lymph node still swollen and very painful, injection site still size of hand. The patient did not receive any treatment for reported events. The clinical outcome of the event loss of appetite was resolved on 25Mar2021 while the clinical outcome of the events fever of 103.8, left underarm lymph node swollen to the size of an egg, severe headache, joint pain, injection site swollen up to the size of hand and very fatigue was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
53 2021-07-10 lymph node swelling Fever; Chills; vomiting; body aches; wobbly legs and arms/weakness in legs and arms; headache; nause... Read more
Fever; Chills; vomiting; body aches; wobbly legs and arms/weakness in legs and arms; headache; nausea; lightheaded; Swollen and red and hot at the injection site; Swollen and red and hot at the injection site; Swollen and red and hot at the injection site; fatigue; swollen lymph node in chest; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via unspecified route of administration in the left arm on 22Mar2021 at 15:30 (at the age 53-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic pericarditis. The patient was allergic to penicillin. Concomitant medications included colchicine (MANUFACTURER UNKNOWN) 20 mg, bifidobacterium infantis; lactobacillus acidophilus (PROBIOTIC), fish oil (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198); via unspecified route of administration in the left arm on 01Mar2021 at 15:30 (at the age 53-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 22Mar2021 at 20:00, the patient experienced fever, chills, vomiting, body aches, wobbly legs and arms, headache, nausea, light-headed, swollen and red and hot at the injection site, fatigue, weakness in legs and arms and swollen lymph node in chest. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatments for the events. The clinical outcome of the events fever, chills, vomiting, body aches, headache, nausea, lightheaded, vaccination site swelling and vaccination site erythema and vaccination site warmth, fatigue, weakness in legs and arms and swollen lymph node in chest was not recovered. No follow-up attempts are needed. No further information is expected.
53 2021-07-12 peripheral swelling, swelling face My body started to swell up including my face and my legs my arm and my throat; My body started to s... Read more
My body started to swell up including my face and my legs my arm and my throat; My body started to swell up including my face and my legs my arm and my throat; My body started to swell up including my face and my legs my arm and my throat; My legs were tingly; Felt like it was closing it didn't close but it was swelling up; My whole body shake like everything was shaking really bad and so I ended up going to hospital in ambulance; "via subcutaneous route"; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via subcutaneous route, administered in arm left in shoulder area on 06Jun2021 at 16:30 (age at vaccination was 53-years-old) (Batch/Lot Number: EW0196) as DOSE 1, SINGLE for covid-19 immunization. Medical history included ongoing hay fever (I take allergy medication for hay fever you know for regular allergy). Concomitant medication included gliclazide (CLARITIN) taken for hay fever, start and stop date were not reported. Prior vaccination (within 4 weeks) was reported as no. The patient stated I just wanted to report my reaction to the vaccine for record purpose. I got the 1st shot, within few hours my body started to swell up, including my face and my legs my arm and my throat. I felt like it was closing it did not close but it was swelling up and my whole body shake like everything was shaking really bad and so I ended up going to hospital in ambulance and they put me on oxygen I could breath but I think they were just worried so they put me on oxygen, and then I spent 5 days in hospital in recovering from it, I just want you guys to know when you collect your data that this was one of the side effects. Patient also stated that her legs were tingly. The event my whole body shake like everything was shaking really bad and so I ended up going to hospital in ambulance resulted in hospitalization. Period of hospitalization was reported as 06Jun2021 to 10Jun2021 (duration 5 days). When asked patient if still experiencing events, the patient stated no, I am fine now, in the hospital they pumped with a lot of fluid and including lot of electrolyte, I had follow-up visit with my doctor and I am very healthy now I am fine, I think they just needed to flush it out of my system. The outcome of the events was recovered on an unspecified date in Jun2021. Information on the lot/batch number has been requested.
53 2021-07-12 swelling face Swelling on left side of face/cheek 2 days after vaccination; lasted approx 1 week following antihis... Read more
Swelling on left side of face/cheek 2 days after vaccination; lasted approx 1 week following antihistamines & steroids; additional swelling 3 weeks later (4/20/21; similar course of treatment and time) and slight swelling 6 weeks later (6/8/21; just zyrtec at night, resolved after 2 days). Saw dermatologist listed, referred me to Internal Med Doctor (blood work normal), then referred to ENT Doctor (seasonal allergy testing normal, possible slight mold/dustmite allergy). Next option CT scan.
53 2021-07-13 peripheral swelling I began to have arthralgias and joint swelling, My legs started swelling and I developed a rash on l... Read more
I began to have arthralgias and joint swelling, My legs started swelling and I developed a rash on left leg. My PCP ran a battery of tests and indicated my A1c was elevated and I had inflammatory labs. I was referred to doctor, rheumatologist and I saw him in late April, early May. Doctor diagnosed me with psoriatic arthritis and told me I was in an immune flare. About 2 weeks or so later I had left leg swelling and the rash to left leg was hot and weepy. I was referred to vascular study and diagnosed with a posterior tibial DVT. My providers suggested I file this report.
53 2021-07-13 swelling significant swelling between collarbone and neck on the side of injection; pain in collarbone; This ... Read more
significant swelling between collarbone and neck on the side of injection; pain in collarbone; This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6205), via an unspecified route of administration in left arm on 17Mar2021 at 13:00 (at the age of 53-year-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included allergy to bixin, asthma, antiphospholipid syndrome and raynauds. Concomitant medications included acetylsalicylic acid (ASPRIN), gabapentin, pantoprazole, cetirizine hydrochloride (CETRIZINE), unspecified medication. The patient previously received rofecoxib (VIOXX) and experienced allergy to Vioxx. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 at 16:15, the patient experienced significant swelling between collarbone and neck on the side of injection, pain in collarbone area. Also moderate swelling in the same area on the other side. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test and procedure which included PCR (other): Unknown results on 22Mar2021. No treatment medications were taken for the events. The clinical outcome for the swelling neck and bone pain was not resolved. No follow-up attempts needed. No further information expected. Amendment: This follow-up report is being submitted to amend previously reported information: VAERS Primary Reporter Addl Qualification updated to patient, age at vaccination updated to 53 years old, narrative relevant sentence updated, past drug event #5 reaction added and coded as drug allergy, allergies to bixin added as relevant med history, vaccine start date/time updated to 17Mar2021 at 13:00, vaccine facility information added, concomitant drug vita removed, then concomitant therapy checked, final sentence in analysis tab updated to no follow-up attempts needed. No further information expected.
53 2021-07-17 lymph node swelling soreness in left shoulder; soreness in arm; soreness in upper back; headache that feels like pressur... Read more
soreness in left shoulder; soreness in arm; soreness in upper back; headache that feels like pressure; headache that feels likepressure; fatigue; tingling in face; sore swollen lymph nodes on left sideof neck; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, obesity, pars planitis (eyes). The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), acetyl salicylic acid (ASPIRIN), paracetamol (TYLENOL), fish oil (MANUFACTURER UNKNOWN), vitamins (MANUFACTURER UNKNOWN). On 12Mar2021 at 23:00, the patient experienced soreness in left shoulder, arm, upper back. headache that feels like pressure plus a tingly spacey feeling in head, fatigue, tingling in face, sore swollen lymph nodes on left side of neck. It was reported that some of effects happened first 3 days and stopped, recurred day 15, day 16, day 18 (today). No therapeutic measures were taken for the reported events. The events did not result in doctor's or other healthcare professional office/clinic visit. The clinical outcome of the events soreness in left shoulder, arm, upper back, headache that feels like pressure plus a tingly spacey feeling in head, fatigue, tingling in face, sore swollen lymph nodes on left side of neck were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
53 2021-07-17 lymph node swelling Sore arm; Tiredness; Arthralgia; myalgia; fever; headache; strange dreams; Nausea; swollen gland (ne... Read more
Sore arm; Tiredness; Arthralgia; myalgia; fever; headache; strange dreams; Nausea; swollen gland (neck); This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the right arm on 09Mar2021 at 16:15 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and gluten allergy (Gluten sensitivity). Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in the right arm on 16Feb2021 at 16:45 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received other vaccines within four weeks prior to the COVID-19 vaccine. On 10Mar2021 at 01:00, the patient experienced sore arm, tiredness, arthralgia, myalgia, fever, headache, strange dreams (bizarre dreams), nausea and swollen gland in neck (gland in neck). The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome for the events sore arm, tiredness, arthralgia, myalgia, fever, headache, vivid dreams, nausea and gland in neck was resolved on unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
53 2021-07-18 lymph node swelling, lymph node pain The day after the second shot April 6, 2021, I had a swollen lymph node and a very swollen and painf... Read more
The day after the second shot April 6, 2021, I had a swollen lymph node and a very swollen and painful right armpit. On approximately April 30 2021, I had a large swollen lymph node above my right collar bone, and a series of smaller swollen lymph nodes along my neck to the an area near the mastoid sinus behind my right ear. On approximately July 10, 2021 I had a swollen lymph node and moderate pain in right armpit. On July 19, 2021 the swollen lymph node and enlarged right armpit returned. PLEASE NOTE that the incidents of lymph node and armpit swelling that occurred in July were smaller and less painful than the initial event that occurred the day after my second injection.
53 2021-07-18 peripheral swelling after first shot, massive headache for 3 days, then deep bone aches that set in and were still going... Read more
after first shot, massive headache for 3 days, then deep bone aches that set in and were still going as of 7/8/2021. the bone aches were so severe that they impacted walking and movement. I was also extremely lethargic & was taking naps when I never do this. in addition, fingers, feet and ankles swelled significantly. this required treatment of steroids by rheumatologist.
53 2021-07-18 peripheral swelling patient states left hand thumb palm area very itchy swollen feels pins and needles
53 2021-07-19 lymph node swelling Swollen lymph node under left armpit; This is a spontaneous report from a contactable consumer, the ... Read more
Swollen lymph node under left armpit; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 22Mar2021 at 10:15 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism. The concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from an unknown start date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. On 24Mar2021 at 09:00, the patient experienced swollen lymph node under left armpit. The patient did not receive any treatment for the event. The clinical outcome of the event swollen lymph node under left armpit was recovering at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
53 2021-07-20 lymph node pain, lymph node swelling I woke up 2 days after the shot was administered and my left armpit lymph nodes were severely swolle... Read more
I woke up 2 days after the shot was administered and my left armpit lymph nodes were severely swollen. It looked like a tennis ball was cut in half and under my skin. I didn?t do anything except take some Tylenol and Motrin. Neither of those helped. It was painful to the touch. I wasn?t able to even put on a shirt. It was gone within 6 days. I had no other issues aside from this. I had no fever, no headaches or anything.
53 2021-07-20 swelling Pt. states that after receiving the Phizer 2nd dose 05/21/2021, 3 weeks after starting experiencing ... Read more
Pt. states that after receiving the Phizer 2nd dose 05/21/2021, 3 weeks after starting experiencing release of pressure/swelling, pain from Non-Specific Mixed Tissue Disease lessening's. States pain and pressure release lasting about a week's time. 06/16/2021 Primary visit stating possible "placebo effect".
53 2021-07-22 swollen extremities, swelling face, peripheral swelling After receiving the first COVID-19 vaccine dose I have experienced severe joints pain and joints sti... Read more
After receiving the first COVID-19 vaccine dose I have experienced severe joints pain and joints stiffness. Also, for a week I had excessive tiredness. More concerning is the postmenopausal bleeding. After 15 months of menopause I started bleeding, having a full period cycle with all the PMS symptoms. The period continued for the next two months.
53 2021-07-25 peripheral swelling Pain in both legs, swelling, and pain in joints both legs, knees, ancles an hips.
53 2021-07-27 lymph node swelling Left armpit pain; Feels like swollen lymph nodes; Nausea; Chills; Left arm pain; Dose 2 administrati... Read more
Left armpit pain; Feels like swollen lymph nodes; Nausea; Chills; Left arm pain; Dose 2 administration date 23May2021; Dose 2 administration date 23May2021; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received second dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Batch/lot number: EW0185) via an unspecified route of administration in left arm on 23May2021 at 15:00 (at the age of 53-years-old) as single dose for COVID-19 immunization. Medical history of the patient included Hyperactive bladder from an unknown date and unknown if ongoing. Patient had no known allergies. Other medications (concomitant) in two weeks included mirabegron (MYRBETRIQ) taken for an unspecified indication, start and stop date were not reported; solifenacin succinate (VESICARE) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. Patient previously received first dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Batch/lot number: unknown) via an unspecified route of ad-ministration in left arm on 31Mar2021 as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 23May2021 at 17:00, patient experienced left armpit pain, feels like swollen lymph nodes, nausea, chills, left arm pain. Treatment received in response to the events included Motrin. Outcome of the events Left armpit pain, feels like swollen lymph nodes, nausea, chills, left arm pain was not recovered. Follow-up attempts are needed. further information is expected.
53 2021-07-27 lymph node swelling Swollen lymph nodes, checked 3 months later with ultrasound and seems resolved; This is a spontaneou... Read more
Swollen lymph nodes, checked 3 months later with ultrasound and seems resolved; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6199) via an unspecified route of administration, administered in left arm on 06Mar2021 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization. Medical history included dystonia and migraines. The patient concomitant medications were not reported. The patient previously took erythromycin and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was yes. Prior to vaccination was the patient diagnosed with covid-19 was no. Since the vaccination, the patient did not test for covid-19. Patient is not pregnant at time of vaccination. On 16Mar2021, the patient experienced swollen lymph nodes, checked 3 months later with ultrasound and seems resolved. The patient underwent lab tests and procedures which included ultrasound scan with results resolved. No treatment received for the adverse events. The outcome of the event was resolved on an unspecified date.
53 2021-07-27 lymph node swelling Higher heart rate; loss of appetite; Burning of skin all over; Fatigue; Joint pain; Headache; Inject... Read more
Higher heart rate; loss of appetite; Burning of skin all over; Fatigue; Joint pain; Headache; Injection site pain; Fever; Chills; Muscle pain; Feeling unwell; Lymph node swelling; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 14Mar2021 at 14:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included PASC (Post-acute Sequelae of COVID-19). Patient had no allergies to medications, food, or other products. Concomitant medications included celecoxib (CELEBREX) 200mg for 2 times a day and salbutamol (ALBUTEROL INHALER) as needed, both from unknown dates for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 29Mar2021, the patient underwent SARS-CoV-2 (nasal swab) and the result was negative. On 15Mar2021 at 00:00, the patient experienced joint pain, fatigue, burning of skin all over, headache, injection site pain, fever, chills, muscle pain, feeling unwell, lymph node swelling, loss of appetite and higher heart rate. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. . The clinical outcome of the events of joint pain, fatigue, burning of skin all over, headache, injection site pain, fever, chills, muscle pain, feeling unwell, lymph node swelling, loss of appetite, higher heart rate was recovered with sequelae on an unknown date. No follow-up attempts are needed. No further information is expected.
53 2021-07-27 swelling trouble sleeping; didn't feel very good; soreness in her arm; hurt like a regular kind of needle; ho... Read more
trouble sleeping; didn't feel very good; soreness in her arm; hurt like a regular kind of needle; hot and cold sweats; hot and cold sweats; headache; swelling; This is a spontaneous report from contactable consumer. A 53-years-old adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0176) via an unspecified route of administration, administered in left arm on 23May2021 at 17:30 as Dose 1,Single for COVID-19 immunization. The patient's medical history included ongoing factor v deficiency, COVID-19 in March 2020. The patient's concomitant medications were not reported. It was reported that, when patient got the first shot, patient did not felt very good after getting it and had the soreness in her arm, it did not really hurt at the injection site when they did it, it hurt like a regular kind of needle. The patient was getting hot and cold sweats after getting it and had a mild headache Patient did not felt good. She only probably slept 2 hours a night for the first whole week that time in Jun 2021 because her head was killing her and it wouldn't let her sleep. Trouble sleeping is still ongoing, its gotten better, it's improved, but its still not good. The patient underwent lab tests including Antibody test with No antibodies found in Oct 2020 and COVID-19 test resulted positive on an unspecified date. The outcome of headache was resolving and hot and cold sweats and trouble sleeping was not resolved The outcome of events didn't feel very good, soreness in her arm, hurt like a regular kind of needle, swelling, chest pain and hot and cold sweats was unknown. No further information was provided.
53 2021-07-29 lymph node swelling can't breathe, taste or smell; sneezing; can't breathe, taste or smell; can't breathe, taste or smel... Read more
can't breathe, taste or smell; sneezing; can't breathe, taste or smell; can't breathe, taste or smell; Congestion; strep throat/she felt like she had strep throat or a sinus infection; Tonsils hurt; Swollen lymph nodes on right side; Chills; Body aches; Injection site on her arm hurt; Tired; sinus infection/she felt like she had strep throat or a sinus infection; She has been experiencing this constant smell of ammonia scent. It almost smells like pee pee to her.; This was a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 11:20 (at the age of 53-years-old) as single dose for covid-19 immunization (Because she wants to be protected) at Hospital. Medical history included asthma from an unknown date and unknown if ongoing. It was reported that she had asthma as a child, but she grew out of it, stress; She used to take pills for stress, but she stopped the stress and doesn't take pills anymore, overweight she was 120 pounds. She has gained about 30 pounds she used to be over 300 pounds, she was overweight, so she had gastric bypass surgery. She smokes cigarettes. She was not a heavy drinker anymore. She does not socialize with people much. She was born a preemie (premature baby). Her health was pretty good. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine were None. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Prior Vaccinations (within 4 weeks) was None. Family Medical History Relevant to the event were None. On 09Apr2021, the patient experienced tired, injection site on her arm hurt. On 10Apr2021, she had tonsils hurt, swollen lymph nodes on right side, strep throat, chills, body aches and Congestion and Whenever she turns her head, she has extreme pressure. Her right neck lymph node was painful to touch. she can't breathe and taste or smell; she has been experiencing that was constant smell of ammonia scent. It almost smells like pee pee to her and sneezing on 16Apr2021. She had sinus infection and she has been experiencing that was constant smell of ammonia scent. it almost smells like pee pee to her on an unspecified date in Apr2021. Congestion was reported as worsened. It was reported that, after that, she was of course tired. She pretty much had all of the symptoms. Then a week later, her tonsils started hurting and her lymph nodes on her right side were swollen. Whenever she turned her head, she had extreme pressure. Her right neck lymph node was painful to touch. A couple of days ago, she felt like she had strep throat or a sinus infection. She can't breathe, taste or smell. Now for several days, she had been experiencing that was constant smell of ammonia scent. It almost smells like pee pee to her. She did not pee pee on herself. She had control over her bladder and bowels. She took today off of work. She has been catching chills. She felt better about the tonsil part. She was born a preemie. She normally gets shots and deals with it. She did not expect the covid vaccine to be any different. She prayed over the covid vaccine. She worked in customer service. She took reservations, she helps patients get rides for back and fourth to the doctor's office. She just relocated and She received the covid vaccine at hospital. The last time she weighed herself, she was at her sister's house and she was 120 pounds. She has gained about 30 pounds since then. She was proud of herself for gaining that weight. She thought she has gained it in all of the right places. She was never meant to be 120 pounds. She had gastric bypass surgery because she used to be over 300 pounds. Stress and heat melted the weight off of her. She removed the stress and now she was gaining weight back. She needs to find a primary care physician; she has not been to the doctor in a few years. She was asking for any primary care physician recommendations. Tired, it has been coming and going, but it has gotten better. The day that she received the first dose of the covid vaccine, she came home and went to sleep. The also slept all day the next day. Chills had been coming and going but are now better. At first, she had constant chills. She gets angry when she gets cold. Injection site on her arm hurt was Began on 09Apr2021. It lasted for 3 or 4 days and then recovered completely. It was not disabling or a problem. Congestion began on 10Apr2021. It started to get really bad on Friday, 16Apr2021, that was the day it hit her like a ton of bricks. She started sneezing, and could not breathe, smell or taste. She got stopped up and could not breathe out of her nose. She felt dry and had to breathe out of her mouth. Swollen lymph nodes on right side. Whenever she turned her head, she has extreme pressure. Her right neck lymph node was painful to touch: She had right sided lymph node pressure. If she puts her finger up to her lymph node, the pain picks up and intensifies. She thinks that it must still be irritated. Tonsils hurt, whenever it started, it felt like she getting strep throat. Her throat was not raw and hot anymore. Began on 10Apr2021. It was recovered completely now. It subsided after a couple of days. She felt better now because she can swallow. She did not know the exact end date. She had been experiencing that was constant smell of ammonia scent. It almost smells like pee pee to her: She can breathe but was still stopped up and has pressure in some areas. It began a couple of days ago, mainly yesterday. She had been smelling it today too. It was ongoing. She will just be breathing and will smell it. It was not constant, but it was happening often. At work, she sits in a corner. Because of covid, her and her coworkers are spaced out pretty good. No one sits directly next to her. She knows that the smell was not coming from herself or her coworkers. The scent was just there everywhere. She was irritated about that was. She knows that her normal senses are not functioning normal. She knew that something was off. Her second dose was scheduled for 30Apr2021. Because she wants to be protected. She has done good with not catching covid. She was trying to protect herself and others. She was a caretaker, she used to be her cousin's caretaker. She was an essential worker. She works in a public office. In May, her family was going to take a vacation. She wanted to protect her elders. She was a smoker. She did not have any medications, medical history or testing that she feels was relevant to that was report. Her health was pretty good. She had asthma as a child, but she grew out of it. She used to take pills for stress, but she stopped the stress and doesn't take pills anymore. She was overweight, so she had gastric bypass surgery. She was healthy. She smokes cigarettes. She was not a heavy drinker anymore. She does not socialize with people much. Event did not require a visit to Emergency Room or Physician Office. She was going to Hospital today to get checked out. The outcome of the events tonsils hurt, injection site on her arm hurt was recovered on Apr2021 while the event body aches resolved on 12Apr2021. The outcome of the events tired, felt like she had strep throat, and chills was recovering. The outcome of the events swollen lymph nodes on right side, and congestion was not recovered. The outcome of the events can't breathe, taste or smell, a sinus infection, sneezing, and she has been experiencing this constant smell of ammonia scent. it almost smells like pee pee to her was unknown. No follow-up attempts are possible. No further information was expected.
54 2020-12-31 swelling Raised red area, that did not itch but became a circle of scabs
54 2021-01-04 anaphylactic reaction Anaphylactic reaction requiring two doses of Epinephren to control. Still having issues; other vacci... Read more
Anaphylactic reaction requiring two doses of Epinephren to control. Still having issues; other vaccine same date product received; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm at 12:30 PM on 18Dec2020 at single dose for COVID-19 immunization, and first dose of other Pfizer vaccine same date product (other vaccine same date lot number: elt9899) on right deltoid on 18Dec2020 for unknown indication. Medical history reported as none. Concomitant medication included vitamin C and colecalciferol (VITAMIN D). The patient experienced anaphylactic reaction at 12:30 PM on 18Dec2020 requiring two doses of epinephren to control. still having issues, resulted in: Doctor or other healthcare professional office/clinic visit, Hospitalization in Dec2020. days hospitalization: 1. The patient received treatment: 2 doses of epinephrine, solumedrol, benadryl, IV and O2 for event anaphylactic reaction to vaccine. The outcome of anaphylactic reaction was not recovered. Lot/Batch and Expiration date has been requested.; Sender's Comments: The information available in this report is limited and anecdotal and does not allow a medically meaningful assessment of the case. There is a plausible temporal association between vaccines administration and onset of the reported event. It is unclear what is the nature of the vaccine co-administered with BNT162b2. Currently no information is available on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.
54 2021-01-04 lymph node swelling, swelling Fever began on 24th around 10 with chills. Took Tylenol for low grade fever about 12:30 pm. Subsided... Read more
Fever began on 24th around 10 with chills. Took Tylenol for low grade fever about 12:30 pm. Subsided for 6 hours and then 6:30 that evening it returned at 100.7. Again 6 hours later, fever was 100.4. Christmas day, still had fever around 100. Then again that afternoon. Lymph node swelling underneath the arm. The site of the injection I had a large knot. Very swollen, small bruise, hot, and red. No streaking or red lines. Lymph node underneath the arm was about the size of a ping pong. I did not want to go to the ER. I called the nurse line and was triaged over the phone. I was instructed to take BP and pulse and gave numbers over the phone. BP was a little elevated, but nothing to extreme. I pretty much stayed laying down. It sucked the life out of me. I used hot compress and cold compress on site of the injection. It was late Saturday evening when I decided to see a change in the size of the lymph node. By Sunday, the 27th, there was no fever. Not even on Saturday. By Sunday, the lymph node had subsided as well. I did get a headache, but it was like a nagging headache. My left shoulder in the muscle area towards the neck area, I had soreness.
54 2021-01-05 axillary mass LARGE AMOUNT OF SWELLING WITH FIRM MASS ON THE UNDERSIDE OF HER ARM, STARTED 5 DAYS POST INJECTION ... Read more
LARGE AMOUNT OF SWELLING WITH FIRM MASS ON THE UNDERSIDE OF HER ARM, STARTED 5 DAYS POST INJECTION , WENT TO WALK IN AND WAS PRESCRIBED STEROIDS AND ANTIBIOTIC, NO IMPROVEMENT AS OF 2 DAYS LATER
54 2021-01-05 c-reactive protein increased, lymph node swelling PATIENT RECEIVED VACCINE ON DEC 18TH. ON DEC 30, PATIENT BEGAN EXPERIENCING HAND AND JOINT PAIN THA... Read more
PATIENT RECEIVED VACCINE ON DEC 18TH. ON DEC 30, PATIENT BEGAN EXPERIENCING HAND AND JOINT PAIN THAT SPREAD TO ENTIRE UPPER BODY. SHOOTING PAINS UP HER NECK AND DOWN HER ARMS. DEVELOPED ITCHY RASH ALL OVER UPPER BODY AS WELL AS HEADACHE AND SWOLLEN LYMPH NODES. CRP WAS 3.6 AND SED RATE 25. COVID TEST WAS NEGATIVE. PATIENT PUT ON MEDROL DOSE PACK AND SYMPTOMS RESOLVED IN 5 DAYS
54 2021-01-05 lymph node swelling patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joi... Read more
patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joint pain and had to take analgesics. Pain radiated through her upper body and at times was shooting. she was unable to perform ADLs. She then developed an itchy rash all over her upper body as well as a headache and swollen lymph nodes. Covid test was negative, CRP was 3.6 and sed rate was 25. all other labsl WNL, symptoms resolved after 5 days
54 2021-01-05 swelling face 20 minutes after receiving the vaccine, patient felt her lips swelling. She then noticed facial swel... Read more
20 minutes after receiving the vaccine, patient felt her lips swelling. She then noticed facial swelling and chest tightness. She then developed erythema to her chest area. She immediately was evaluated. Denies any SOB or difficulty breathing. Denies any itching or hives.
54 2021-01-05 swelling face Approximately 10 minutes after injection tingling in right hand, red splotchy skin on palm of hands ... Read more
Approximately 10 minutes after injection tingling in right hand, red splotchy skin on palm of hands and forearms. Approximately 15-20 minutes after injection. Tingling in feet and lower extremities. Thirty minutes after injection slight itching at injection site. Approximately 1 1/2 hours after injection splotchy red skin inside both thighs and mild generalized itching. At 2:00 pm that day of injection tingling began in face with slight swelling in cheeks. Itching lasted 3 days. Currently intermittent itching since Monday 01/03/2021.
54 2021-01-07 lymph node swelling Extreme fatigue, swollen lymph node near collarbone, nausea on day two post second vaccination
54 2021-01-07 swelling face I woke up 6 hours after the vaccine with significant swelling in my face; This is a spontaneous repo... Read more
I woke up 6 hours after the vaccine with significant swelling in my face; This is a spontaneous report from a contactable nurse, the patient. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL0140, via an unspecified route of administration on 29Dec2020 at 07:30 (at the age of 54 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergies to azithromycin and compazine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 29Dec2020, the patient stated she woke up 6 hours after the vaccine with significant swelling in her face. It did not affect her breathing. She took 50 mg Benadryl . The swelling was gone 4 hours later. The clinical outcome of swelling in her face was recovered on 29Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
54 2021-01-07 swelling, swelling face At night I felt fatigue and palpitations and could not sleep. Next morning the palpitations and fati... Read more
At night I felt fatigue and palpitations and could not sleep. Next morning the palpitations and fatigue went away but I start with a rash and very itchy and noticed my face swelling up. I took some prednisone I had home and Benadryl and went to the ER. They monitored me and medicated me and told me to keep with the Benadryl. On the 24th I started with the rash and on the 26th no more rash. My second dose is scheduled on the 13th and I will see my PCP on the 12th to decide if I should have the second dose. I am not allergic to anything and thought I would die on 12/24. I was swelling up in less than a minute after I woke up it was awful. I also have a consultation with an allergist on Tuesday before the vaccine.
54 2021-01-09 lymph node swelling 15 hours of feeling febrile with no fever and severe body aches - next day woke with a painful and v... Read more
15 hours of feeling febrile with no fever and severe body aches - next day woke with a painful and very swollen arm pit in the arm where i was vaccinated, today is day 2 of swollen painful arm pit.
54 2021-01-10 anaphylactic reaction 10days after receiving vaccine developed an anaphylactic allergy after eating shellfish which I was ... Read more
10days after receiving vaccine developed an anaphylactic allergy after eating shellfish which I was never allergic to. I developed a red itchy rash over the entire body with throat tightening. Went to ER where I was treated with H1 H2 blockers steroids. After being treated and observed for a few hours I re developed the rash and symptoms again requiring further treatment and observation.
54 2021-01-10 peripheral swelling Pain and swelling with numbness into left arm and into neck. Also body aches and chills with cramps ... Read more
Pain and swelling with numbness into left arm and into neck. Also body aches and chills with cramps in arms and legs. Feelings of restless, stomach upset. Knee charley horses.
54 2021-01-11 lymph node swelling Symptoms: severe (high fever (101.6F), body ache, headache, shivering, lymphadenopathy) Treatment:... Read more
Symptoms: severe (high fever (101.6F), body ache, headache, shivering, lymphadenopathy) Treatment: Tylenol 325mg (650mg Q4hrs) followed by Naproxen 250mg (Q12hrs), lots of fluids and rest Time Course: 2 days
54 2021-01-12 swelling face Woke up on the 24th with a puffiness in the face, patient looked at the back of her throat and noti... Read more
Woke up on the 24th with a puffiness in the face, patient looked at the back of her throat and noticed some swelling, pt was able to maintain the airway. Pt was able to stay monitor sx which resolved the next day.
54 2021-01-13 lymph node swelling, lymph node pain I just wanted to inform you of my reaction that I had with my Covid Vaccine #2: (all resolved within... Read more
I just wanted to inform you of my reaction that I had with my Covid Vaccine #2: (all resolved within 24-48 hours ~ except the Right Axillary Lymph Node Swelling and Pain ~ This is still currently present, please let me know if you want me to let you know when this last symptom/reaction resolves?) Fatigue Sore Right Arm (injection) Chills Fever Headache Cough Right Axillary Lymph Node Swelling and Pain
54 2021-01-13 lymph node swelling Axilla lymph node swelling of the vaccinated arm. Swelling began the day after vaccination. Reporte... Read more
Axilla lymph node swelling of the vaccinated arm. Swelling began the day after vaccination. Reported to Employee Health 2 days after vaccination and area measured 70mm at that time. No tenderness noted to palpation. Patient is taking ibuprofen. Encouraged to follow with PCP if swelling continues.
54 2021-01-13 lymph node swelling Chills , body aches, fatigue, swollen lymph nodes in right axilla, throat, and under right clavicle
54 2021-01-13 swelling Systemic: swelling on entire left side of body
54 2021-01-14 lymph node swelling Lymphadenopathy under left clavicle 2 days post injection. Also had minor headache 1 day post vacci... Read more
Lymphadenopathy under left clavicle 2 days post injection. Also had minor headache 1 day post vaccination which resolved by day 2. No medical treatment needed at this time.
54 2021-01-14 swelling face 1st covid vaccine received on 12/31/2020. On 1/2/2001 in the am had her right eye and cheek swollen,... Read more
1st covid vaccine received on 12/31/2020. On 1/2/2001 in the am had her right eye and cheek swollen, headache and chills by afternoon mouth and right eye was drooping. Was prescribed RX prednisone on 1/15/2021. Current symptom (1/15/2021) is mouth drooping, other swelling and eye drooping resolved. Reports has occurred twice before. About 7 years ago with unknown etiology, lasted for about 6 months, Occurred again about 5 years ago with unknown etiology and lasted about one month.
54 2021-01-15 lymph node swelling Low grade fever, severe joint pain and headache 16 hours post injection. Headache for over 72 hours.... Read more
Low grade fever, severe joint pain and headache 16 hours post injection. Headache for over 72 hours. Large swollen right supraclavicular lymph node noticed at 72 hours post injection. Painful and warm to touch approx size golf ball. Entire right clavicle swollen and painful.
54 2021-01-18 lymph node swelling Body aches and swollen glands under left arm for first 28 hrs. After 28 hrs fever built up to 101.2... Read more
Body aches and swollen glands under left arm for first 28 hrs. After 28 hrs fever built up to 101.2 along with rapid heart beat, increased body aches, pounding heart and sweating. Symptoms lessoned in the morning. Fever returned the next evening (Friday 1/15). Cleared by Saturday except for tiredness. Entire episode completed by Saturday morning 1/16/21. No hospitalization or MD visit. Would have visited my Primary MD, but they referred me to the organization administering the vaccine. Vaccine was given out at work, there isn't a medical clinic available for employees.
54 2021-01-18 swelling, lymph node swelling Severe Headache began on Sunday 1/17/2021, then Monday 1/18/2021 I developed Left axillary lymph nod... Read more
Severe Headache began on Sunday 1/17/2021, then Monday 1/18/2021 I developed Left axillary lymph node edema and left groin swollen lymph node.
54 2021-01-18 swelling, lymph node swelling Arm sore at injection site for a few days. I noticed several days later that my neck (part between ... Read more
Arm sore at injection site for a few days. I noticed several days later that my neck (part between neck & shoulder) was swollen. I had a few lumps. I had swollen lymph nodes.
54 2021-01-19 lymph node swelling SWOLLEN AXILLARY LYMPH NODE ON INJ ARM Narrative:
54 2021-01-19 peripheral swelling Sore right arm where I received the shot. Swelling and soreness in my shoulder. Sore neck.
54 2021-01-19 swelling face Face (cheeks, forehead, chin) red (sunburn look) and swollen. Occurred several hours after re... Read more
Face (cheeks, forehead, chin) red (sunburn look) and swollen. Occurred several hours after receiving vaccine.
54 2021-01-19 swelling face Swelling in my face. I went to the ER on Saturday Morning 1/16/2021 at 10;30 am. I was put on Predni... Read more
Swelling in my face. I went to the ER on Saturday Morning 1/16/2021 at 10;30 am. I was put on Prednisone and sent home. The swelling was due to too many antibodies in my system.
54 2021-01-20 lymph node swelling Pain & swelling in left lymph node under left arm. Noticed it Dec. 23, 2020, saw healthcare provide... Read more
Pain & swelling in left lymph node under left arm. Noticed it Dec. 23, 2020, saw healthcare provider Dec. 28, it had not gotten better. I was to watch it. Pain eventually went away Jan. 4, 2021. Received 2nd covid vaccine Jan. 6, 2021.
54 2021-01-20 peripheral swelling sore and swollen left arm within a couple hours, later same day some fatigue, next day some aches, ... Read more
sore and swollen left arm within a couple hours, later same day some fatigue, next day some aches, and low grade temperature. Mild headache started suddenly around 8 hours after injection and continued for about 16 hours.
54 2021-01-20 swelling Swelling in axilla
54 2021-01-21 anaphylactic reaction It felt similar to the beginning of an anaphylactic reaction I had a few years ago to a random food ... Read more
It felt similar to the beginning of an anaphylactic reaction I had a few years ago to a random food (never found out what the allergen was). About 20 minutes after receiving the vaccine, my throat felt strange, my sinuses started getting congested, my ears started plugging. I felt dizzy when walking. I spent extra time at the clinic under observation. About 40 minutes after receiving the vaccine, I suddenly felt like I was being sucked into a vacuum and thought I was going to pass out. I alerted the nurses, who checked my vital signs and put me on O2. My heart rate was normal, my BP was high, my O2 sat was 100%. After about 5 minutes I started to feel normal, they removed the O2. They continued to observe me for another 15 minutes, until I felt better. As I drove home (about 1 hour 10 min after receiving the vaccine), my face and lips became numb. I continued driving home and the numbness resolved in about 10-15 minutes. I notified my doctor of the event and she advised me not to get the second dose and to report the event.
54 2021-01-21 lymph node swelling SORENESS AT SIGHT, NO ENERGY/ SWOLLEN LYMPH NODES
54 2021-01-21 swelling redness, swelling and slight itchiness to left arm
54 2021-01-24 lymph node pain Very sore right arm radiating under my arm, neck, and right breast area. Very tender to palpate lym... Read more
Very sore right arm radiating under my arm, neck, and right breast area. Very tender to palpate lymph nodes under right arm and neck. Tender right breast as well. Symptoms from the first night after the second vaccine and still 13 days later.
54 2021-01-24 peripheral swelling Extreme pain with swelling of left upper arm at injection site. Pain and swelling continues down arm... Read more
Extreme pain with swelling of left upper arm at injection site. Pain and swelling continues down arm to hand. Started 1/20/2021 and continues to worsen. Pain unbearable.
54 2021-01-24 peripheral swelling On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain. Swelling in pm and pain continu... Read more
On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain. Swelling in pm and pain continued x 4 days, then, local tenderness persisted for additional week. Onset of HA 1/18/21 through 1/25/21 for 6 of the 7 days, for a few hours duration and relieved with Aleve qd to BID. On 1/22/21 noticed Left shoulder muscle weakness, visible atrophy of muscle and dull pain in shoulder/arm and neck. clicking in the joint with rotation movement. spoke with Director of Rehab and advised to contact and seek medical care. Call placed to PCP 1/23/21 with office closed for the weekend. due to non-urgent symptoms, opted to wait for appointment on Monday. Continued pain and symptoms through the weekend with feeling of instability in the shoulder. spoke to company for Q/A on 1/24/21 and sought medical attention with appointment for care on 1/25/21.
54 2021-01-24 swelling On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain. Swelling in pm and pain continu... Read more
On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain. Swelling in pm and pain continued x 4 days, then, local tenderness persisted for additional week. Onset of HA 1/18/21 through 1/25/21 for 6 of the 7 days, for a few hours duration and relieved with Aleve qd to BID. On 1/22/21 noticed Left shoulder muscle weakness, visible atrophy of muscle and dull pain in shoulder/ arm and neck. Clicking in the joint with rotation movement. Spoke to Director of Rehab and advised to contact CDC and seek medical care. Call placed to PCP 1/23/21 with office closed for weekend. Due to non-urgent symptoms, opted to wait for appointment on Monday. Continued pain and symptoms through the weekend with feeling of instability in the shoulder. Spoke to CDC for Q/A on 1/24/21 and sought medical attention with appointment for care on 1/25/21.
54 2021-01-26 lymph node swelling Large amount of swelling in my left armpit
54 2021-01-27 lymph node swelling The patient reported numbness, tingling, and heaviness in vaccinated arm which travelled up neck, to... Read more
The patient reported numbness, tingling, and heaviness in vaccinated arm which travelled up neck, to eyelid and side of face. This prompted a visit to urgent care and urgent care sent the patient to the ED for stroke rule-out. The ED did not believe patient was experiencing a stroke and administered 10 mg of IM decadron. The patient's symptoms resided overnight but the next day developed red bumps all over upper palate of mouth. The patient went to her PCP which did not test for strep at this time. The red bumps developed into ulcers with white heads and the patient went back to the PCP which performed a rapid strep test which was negative. The PCP was concerned for mono due to lymph node swelling. The patient's palate has improved slightly but they still feel fatigued.
54 2021-01-27 lymph node swelling She noticed redness, itchy swelling around the injection site, along with a sore arm and a shotty ly... Read more
She noticed redness, itchy swelling around the injection site, along with a sore arm and a shotty lymph node in the right axilla
54 2021-01-27 swelling face, swelling Lip and facial swelling on the left side of my face. Took 50 of benadryl which took several hours to... Read more
Lip and facial swelling on the left side of my face. Took 50 of benadryl which took several hours to work. Was placed on 3 days of prednisone to decrease the swelling. Prednisone did decrease the swelling. Spoke with my primary doctor on the phone as it was after hours by the time I called him who prescribed the prednisone.
54 2021-01-28 lymph node swelling pt states she has sore left arm around the injection site and looks like she had two injection marks... Read more
pt states she has sore left arm around the injection site and looks like she had two injection marks. Pt states she has had headaches and pain in the clavicle area with swelling in her lymph nodes on the left side.
54 2021-01-30 swelling Pain , swelling , fatigued , sleeping
54 2021-01-31 lymph node pain, lymph node swelling Feel tired, chill, mild fever(100.9F), Whole body ache(muscle, bone, nerve pain) with headache, Sens... Read more
Feel tired, chill, mild fever(100.9F), Whole body ache(muscle, bone, nerve pain) with headache, Sense of smell and taste lower down, tonsil swelling, Lymph node swelling and pain.
54 2021-01-31 swollen extremities body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; ... Read more
body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; a little swelling; throat dry at night; joint pain/ankle pain; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 08Jan2021 14:00 at a single dose for COVID-19 immunization. The patient medical history was none. Patient's concomitant medications were not reported. The patient previously took cortisone. It was reported that the patient got the vaccine on 08Jan2021 and started having the headaches right after. Still has some pain in the forehead and temples area. Has had neck pain, overall body aches, joint pain, pain in ankles and legs that still happens with getting up and down from sitting position. Overall pain is improved but still there, still has pain in ankles and legs. Got the shot in the left upper arm and having real bad armpit pain and a little swelling there. It has gotten a little better, but mostly hurts when moving and laying down. Has had a cough since she got the vaccine, it's mostly a dry cough and not really wet and mostly in the morning. She drinks a lot of fluids throughout the day and still has a little cough off and on. During the night her throat is really dry and which causes more coughing which she did not have before the vaccine. They are mostly concerned with the cough and the stuff when read online about the side effects that last about 2-3 days, but these have been since she got the vaccine. They know this is also know and not much known about it or what is normal yet, but they want to know if she could get the second vaccine, would it be okay. It was stated that the seriousness of the events is in the middle of not serious and medically significant. She is worried about the cough since it is ongoing, when reads online the side effects are listed as 2 or 3 days and her side effects have been going on since she got the vaccine which is worrisome. The outcome of the events cough and throat dry was not recovered, event pain was recovering, while the outcome of the rest of the events was unknown. Information on the Lot/batch number has been requested.
54 2021-01-31 peripheral swelling fever, nausea, rash all over body, painful swollen knees and hands, and shortness of breath. She ha... Read more
fever, nausea, rash all over body, painful swollen knees and hands, and shortness of breath. She had an eppy-pin she used.
54 2021-02-03 swollen extremities Swelling of left axilla, approximately baseball sized starting 2/3/2021 unresolved
54 2021-02-03 swelling face 10-15 minutes after injection splotchy redness forearms, palm of hands. Approximately 1 hour after i... Read more
10-15 minutes after injection splotchy redness forearms, palm of hands. Approximately 1 hour after injection splotchy redness both legs. Approximately 2 hours after injection tingling around neck, tingling in lips and swelling and tingling right side of face and voice change hoarseness.
54 2021-02-04 lymph node swelling, lymph node pain Swollen/painful left axillary lymph glands.
54 2021-02-04 peripheral swelling HEADACHE, TEMPERATURE 101.4, DEEP MUSCLE ACHES, FATIGUE. AFTER DAY TWO AFTER INJECTION I STILL HAD A... Read more
HEADACHE, TEMPERATURE 101.4, DEEP MUSCLE ACHES, FATIGUE. AFTER DAY TWO AFTER INJECTION I STILL HAD A HEADACHE THAT I COULD'NT GET RELEIF FROM WITHOUT MIGRAINE MEDICATION. DAY 3 I HAD A VERY SORE AND SWOLLEN ARM BUT OTHER SYMPTOMS SUBSIDED. DAY 4 A LITTLE FATIGUE BUT FEELING GOOD.
54 2021-02-09 lymph node pain Very sore right arm; Very sore right arm, right underarm; right breast pain; Tender lymph nodes unde... Read more
Very sore right arm; Very sore right arm, right underarm; right breast pain; Tender lymph nodes under the right arm, and the right side of the neck; Tender lymph nodes under the right arm, and the right side of the neck; tender right breast; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3248) via an unspecified route of administration in right arm on 12Jan2021 10:15 at single dose for COVID-19 immunization. Medical history included HTN (hypertension) hereditary. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN HCTZ), verapamil hydrochloride (VERAPAMIL). The patient previously received the first dose of bnt162b2 (Lot number: EK5730) on 22Dec2020 11:00 in right arm for COVID-19 immunization. Events started from 12Jan2021 18:00 included very sore right arm, right underarm, and right breast pain onset the evening of the second dose, tender lymph nodes under the right arm, and the right side of the neck, also, tender right breast. All symptoms still present 13 days later, but better. The adverse event result in Doctor or other healthcare professional office/clinic visit. This is a non-serious report per reporter. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
54 2021-02-10 lymph node swelling Headache, slight fever-100, swollen lymph nodes under arm and on neck
54 2021-02-10 swelling dry and reddened rash; the rash is so itchy and swollen; the rash is so itchy and swollen; This is a... Read more
dry and reddened rash; the rash is so itchy and swollen; the rash is so itchy and swollen; This is a spontaneous report from a contactable Nurse. A 54-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL9261) vaccine , via an unspecified route of administration in the left shoulder on 18Jan2021 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient received the first dose of BNT162B2 vaccine on 28Dec2020. The patient experienced dry and reddened rash in the anterior side of her neck in the shape of her thyroid. on 22Jan2021 with outcome of not recovered , the rash is so itchy and swollen on 22Jan2021 with outcome of not recovered. The reported events were considered Important Medical Events. The patient used her son's eczema cream, clarified as "Elcom" or "Elecom" but the events worsened.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
54 2021-02-15 peripheral swelling patient came back in after four or more hours from vaccine administration with complaint of redness ... Read more
patient came back in after four or more hours from vaccine administration with complaint of redness on her fingertips. no itching, shortness of breathe noted. did assess that patient had additional redness and some slight swelling on the left hand as well. Patient received the vaccination in that arm.
54 2021-02-17 lymph node swelling, peripheral swelling Initial swelling on lymph node under the left axilla with pain and warm to touch on 2-5-21. Contact... Read more
Initial swelling on lymph node under the left axilla with pain and warm to touch on 2-5-21. Contacted MD who prescribed Augmentin 500 mg BID for 10 days. On day 13 after vaccine the swelling went away. Joint pain began on Feb 5th including hips, knees , ankles, wrist and elbows and continues to today. Rash began on both legs (thighs and calf) and hands. Raised rash non pustule red in color. This began approximatly 1 week post vaccine. Right hand began swelling on 2/16/21 with pain and redness. On 2/17/21 swelling increased and increased pain. Pain in right hand and wrist is worse on 2-18-21 (pain scale 6)
54 2021-02-18 anaphylactic reaction Anaphylaxis
54 2021-02-18 peripheral swelling, lymph node swelling swollen left arm down though elbow area, swollen underarm area, swollen and pain left side of breast... Read more
swollen left arm down though elbow area, swollen underarm area, swollen and pain left side of breast up near under arm, could not lift left arm, painful down arm, up neck area, still having pain in arm. Pain is subsiding gradually daily, still noticeable.
54 2021-02-22 peripheral swelling Bilateral subcutaneous swelling in each arm that has persisted for 1 month following vaccine (had do... Read more
Bilateral subcutaneous swelling in each arm that has persisted for 1 month following vaccine (had doses in separate arms and nodules developed after each vaccine)
54 2021-02-22 swelling Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with dimin... Read more
Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with diminish flow, tingling of the lips and tongue, pressure, tightness and pain in the chest. shortness of breath, right sided weakness and tingling of limbs and face. 50 ml of Benadryl, and 2 shots of epinephrine was given before transported to the Emergency Room via Ambulance On 2/22/2021 was sent to Urgent Care with the same symptoms. Urgent care sent me back to the Emergency room with heart arrythmias, chest tightness, tingling of lips and tongue.
54 2021-02-23 lymph node swelling fever, - up to 102, chills, headache, muscle aches, joint aches, tiredness, injection site pain and... Read more
fever, - up to 102, chills, headache, muscle aches, joint aches, tiredness, injection site pain and swelling, swollen lymph nodes in underarms- more pronounced in arm where shot was received.
54 2021-02-23 swelling Hives/swelling/puritis (of head/face, neck, chest, arms) and elevated blood pressure. IM Benadryl at... Read more
Hives/swelling/puritis (of head/face, neck, chest, arms) and elevated blood pressure. IM Benadryl at vaccination site IM steroid and prescription for steroids in ED
54 2021-02-24 peripheral swelling I noticed a slight swelling of my palms near the wrists on the following morning of my first dose of... Read more
I noticed a slight swelling of my palms near the wrists on the following morning of my first dose of the Covid vaccine. I took a dose of pseudoephedrine and the swelling went down. Other reactions were tiredness and injection site pain.
54 2021-02-25 lymph node swelling Still experiencing Swollen Lymph nodes under arms
54 2021-02-25 peripheral swelling Fatigue and chills the first 24 hours then itchy, swollen bump on arm at day 7, 8 ,9 ( still swollen... Read more
Fatigue and chills the first 24 hours then itchy, swollen bump on arm at day 7, 8 ,9 ( still swollen currently at day 9)
54 2021-02-28 lymph node swelling pain above nipple, underarm lympnode is swollen
54 2021-02-28 lymph node swelling Armpit on injection side began to form a lump. Swelling progressed into my Left breast. Went into ... Read more
Armpit on injection side began to form a lump. Swelling progressed into my Left breast. Went into my clinic 2/25/2021 and was examined- was told this was a very common side effect of the vaccine.
54 2021-03-02 swelling face Rash, hives, swelling face, mouth tongue, nose, ears, eyes. Beet red face. Blood pressure normally... Read more
Rash, hives, swelling face, mouth tongue, nose, ears, eyes. Beet red face. Blood pressure normally low 110/70 but went from 166/86 at 1333 HR 80 02 100%, then BP 163/88 at 1404 HR 74 02 100%, then at 1409 HR 68 BP 175/110 RR24 O2 100% 1405 - 911 called took benadryll at 1330 (25 mg) then again 1349 took 2nd dose of benadryll 25 mg liquid capsules. PT has adverse reactions to epinephrine. 1412 tongue swelling. by 330 pm patient went home prepared to go to ER if anything changed. She walked around in cool air and had hives move around her body. Not shot in upper right arm. It was tasted during injection. Then after the shot reactions kicked in at 20 minutes moving up the right side primarily same as shot side. Arms, chest, and face flush off and on. Swelling moved around.
54 2021-03-03 swelling 10 minutes after the first dose, I developed a severe headache and a sharp increase in blood pressur... Read more
10 minutes after the first dose, I developed a severe headache and a sharp increase in blood pressure. My blood pressure returned to normal within 40 minutes but I had a persistent headache for 19 days. After second dose, the headache returned with greater severity and my PCP had to prescribe a course of prednisone to help reduce the pain. There was no blood pressure change with the second dose. I also had profound fatigue and was in bed for 48 hours after both doses. My current condition is that the headache and swelling has resolved on right side of temple after 3 days on prednisone but I still have selling and pain, though reduced on left side. I also had typical pain at site injection and received both doses in my right arm.
54 2021-03-05 swelling face 3/6/21 5:07am, woke with red, swollen face like a shellfish allergy reaction. Top of chest right bel... Read more
3/6/21 5:07am, woke with red, swollen face like a shellfish allergy reaction. Top of chest right below neck was red. Face and red area of chest itchy. Went to quick care, received steroid injection and prescriptions for hydroxyzine and prednisone.
54 2021-03-06 peripheral swelling Symptoms occurred with 2nd covid dose. Pfizer lot number is unclear and may not be correct due to s... Read more
Symptoms occurred with 2nd covid dose. Pfizer lot number is unclear and may not be correct due to sloppy handwriting. Days 1-5 with increasing left arm soreness at injection site. Also increasing left wrist joint pain, left elbow joint pain, and left shoulder joint pain. Day 5 and 6 were the worst for joint pain. Very uncomfortable. No fevers. Day 7 with swollen left arm pit and swollen left breast. Arm pit and breast with mild pains and painful to touch or move. Joint pains subsiding . Days 8 -14 continues with the same symptoms of left arm pit swelling, left breast swelling and pains. No skin discoloration and no warmth. No change in swelling , discomfort or pain from days 8-14, but not any better. Can?t wear bra or do yoga.
54 2021-03-08 lymph node swelling pea size node palpable left clavicular region; almond size node palpable left axillary region
54 2021-03-11 oral herpes Cold sore, mouth sores, itchy burning eyes, abdominal rash, itchy skin head to toe, vertigo, dry cou... Read more
Cold sore, mouth sores, itchy burning eyes, abdominal rash, itchy skin head to toe, vertigo, dry cough, shortness of breath, traveling leg pain, development of ear infection, dizziness
54 2021-03-11 peripheral swelling Swollen arm, underarm area left side of breast. Weakness in arm, gradually diminishing daily
54 2021-03-11 swelling face, swelling At the time of the injection, I had numbness in my left fingertips, and my tongue was bitter/burning... Read more
At the time of the injection, I had numbness in my left fingertips, and my tongue was bitter/burning for few minutes. The Doctor in place informed that it was a normal reaction. Everything was going well until I went to sleep. I woke up in panic due to not being able to breath. I felt like my brain, face, eyes, and nose were swelling. My chest was compressed. Then I remembered I didn't take any medication; therefore, I took two Advil. After and hour, I noticed that by sitting or walking , I began to feel better. I went back to sleep in a seated position around 4:30. Not sure if I want to take the 2nd dose. I'm frighten. Have an appointment with my Doctor on March 22nd.
54 2021-03-13 lymph node swelling Fatigue, nausea, headache, pain at injection site, pain in right side of my neck and swollen muscle ... Read more
Fatigue, nausea, headache, pain at injection site, pain in right side of my neck and swollen muscle and lymph gland in right front collar bone. All symptoms were within hours of administration except the swollen lymph gland. The gland was about 36 hours after administration. I have not pursued treatment at this point.
54 2021-03-14 lymph node swelling SHORTNESS OF BREATH ,PRESSURE IN CHH EST, NAUSEA, FEVER 101-102, SWOLLEN NECK GLANDS
54 2021-03-15 lymph node pain, swelling Soreness at injection site on the first day, around 24 hours later developed all over aches, lighthe... Read more
Soreness at injection site on the first day, around 24 hours later developed all over aches, lightheadedness, chills, and weakness to the point of not being able to ambulate. This lasted for two days, then started getting extremely swollen, sore lymph nodes under left arm to the point of not being able to tolerate wearing a bra along with dizziness and nausea. This has persisted for two days so far.
54 2021-03-15 lymph node swelling Swollen, painful neck gland(s) left side of neck. Low grade if any fever but feeling feverish and i... Read more
Swollen, painful neck gland(s) left side of neck. Low grade if any fever but feeling feverish and indisposed, tired, fatigued. NOT my energized self.
54 2021-03-16 swelling face feeling of warmth and swelling on the face
54 2021-03-17 lymph node swelling SWOLLEN GLANDS, INJECTION SITE
54 2021-03-17 swelling c/o acute onset occipital headache, R. throat swelling, neck swelling, tongue swelling, difficulty ... Read more
c/o acute onset occipital headache, R. throat swelling, neck swelling, tongue swelling, difficulty swallowing saliva by report. No resp difficulty. Resp 16/min - nlabored SPO2 98%, HR 101, BP 160/85. 12:30pm Epi 0.3mg given R. thigh via auto injector by anaphylactic type reaction. All transport to closest ER.
54 2021-03-18 lymph node pain, lymph node swelling flu-like symptoms (tired, body aches) for first evening and third evening after vaccination. Also sw... Read more
flu-like symptoms (tired, body aches) for first evening and third evening after vaccination. Also swelling/tenderness under right arm (lymph nodes?) and right breast that lasted two weeks. Vaccine was administered in left arm. No swelling/tenderness at vaccinated area. I am usually really sore at vaccinated area after flu shots.
54 2021-03-18 lymph node swelling, swelling face I have been feeling tired since the vaccine and have had a chronic low-grade headache since as well.... Read more
I have been feeling tired since the vaccine and have had a chronic low-grade headache since as well. Things have been okay until a couple of days ago. I am a fanatic about skincare. I developed a water blister-type rash on the right side of my chin ( not in my mouth). The very next day, my neck started to hurt, and I noticed that my lymph node is swollen on the right side of my neck, just under my jaw. The blisters have crusted over, but my chin and a bit of my cheek are swollen.
54 2021-03-19 lymph node swelling Under my right arm in my arm pit is hurting and it feels like maybe my lymph nodes are swallen.
54 2021-03-20 swollen extremities Itching, , severe headache, swelling or lump under right armpit with severe pain, pain in area of ... Read more
Itching, , severe headache, swelling or lump under right armpit with severe pain, pain in area of injection , chest pain , runny nose, chills, fever, nausea, fatigue, muscle and body aches especially on right side.
54 2021-03-21 lymph node pain Starting at 5 p.m. on March 18th (two days post-vaccine), pain began in the lymph node area of the l... Read more
Starting at 5 p.m. on March 18th (two days post-vaccine), pain began in the lymph node area of the left side of the neck. It became increasingly painful on March 19 in the evening (especially after dinner) and overnight (around 3 a.m.) and more painful in the evening on March 20th after dinner. On March 20th, I took 800 mg ibuprofen (4 tablets) at 6 p.m. to relieve the pain. My husband is an Emergency Physician and indicated that is the dose I should take given the pain. At 1:00 p.m. on Sunday the lymphnodes on the left side of the neck began hurting again (excruciating pain) and I again took 800 mg of ibuprofen to relieve the pain. This occurred after having lunch (a burger) at noon. However, at 1:30 p.m. the left side of my face began to feel numb. I had little control of the left side of my mouth and could not close my left eyelid properly. The numbness lasted for about 20 min and then subsided. After 40 min (2:10 p.m.) it felt better and I had a few potato chips left over from my lunch. The numbness started again about 10 min later and lasted about 20 min. The face went numb again the evening of March 22nd for 20 min despite remaining on ibuprofen 3 times a day.
54 2021-03-21 swelling face When I laid down for bed my tongue felt weird on my left side. I looked in the mirror and the left ... Read more
When I laid down for bed my tongue felt weird on my left side. I looked in the mirror and the left side of my face was swollen around the cheek. I have a little soreness around the jaw. My left are was sore to the touch and slight stiff where I cannot raise my arm all the way. I took 2 Benadryl tablets.
54 2021-03-22 white blood cell count increased Approximate 20 hours after receiving dose #2 of vaccine, presented with symptoms of stroke: aphasia... Read more
Approximate 20 hours after receiving dose #2 of vaccine, presented with symptoms of stroke: aphasia, unable to process thoughts quickly, unable to write legibly, jarbled speech. I was working night shift at the hospital. I was immediately taken to the emergency department. Placed on monitor, labs drawn, neurochecks, EKG. Could not identify some simple pictures, could not recall my co-workers name ( worked with her for 25 years). CT done within 15 minutes of symptoms. MRI completed. Episode lasted approximately 45 minutes.
54 2021-03-24 anaphylactic reaction severe fatigued/fatigue; red eyes; fever; Darkened skin in face; Itchy scalp and subsequent hair; ha... Read more
severe fatigued/fatigue; red eyes; fever; Darkened skin in face; Itchy scalp and subsequent hair; hair loss; headaches; Anaphylaxis; hives; itching breathing, lips, throat impacted; itching breathing, lips, throat impacted; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 23Feb2021 at 01:00 PM (at age of 54-year-old) as SINGLE DOSE for covid-19 immunisation, Lot Number: EN6198. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 03Feb2021 in Left arm for COVID-19 immunisation, Lot number: EL8982. Medical history was not reported. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. On 23Feb2021 within 20 mins patient experienced anaphylaxis, hives, itching breathing, lips, throat impacted. On 23Feb2021 at 02:00 PM (also reported as over next week) patient experienced severe fatigued; red eyes; fever; darkened skin in face; subsequent results, Itchy scalp and subsequent hair; seeing hair loss continuing and fatigue, headaches ongoing thus far. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatments received included Anaphylaxis medicine, intravenous (Iv) administration; prescript. Patient had not recovered from the events, at the time of the report.
54 2021-03-24 lymph node swelling Injection site pain for one week after vaccination Tiredness and Fatigue for one day after vaccinati... Read more
Injection site pain for one week after vaccination Tiredness and Fatigue for one day after vaccination Nausea and Vomiting. Vomited 4 times over the course of 6 hours. Slept for 5 hours and felt better. Swollen lymph nodes for 3 days after vaccination.
54 2021-03-25 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lightheadness-Medium
54 2021-03-25 lymph node swelling pain in left arm, swollen lymph node in the neck on the left side, measures approximately 1.5 cm, no... Read more
pain in left arm, swollen lymph node in the neck on the left side, measures approximately 1.5 cm, not painful, movable.
54 2021-03-25 lymph node swelling Severe pain in left arm outside of injection, move down the whole arm to the bottom arm was numb for... Read more
Severe pain in left arm outside of injection, move down the whole arm to the bottom arm was numb for over 12 hours. Left side of the neck pain, left lymph node glands under the arm severely swollen, earache and left side, and extreme fatigue. Now 43 hours later after the injection I can move my arm but still cannot touch the site of the injection, left ear still hurts, left side of neck still painful but better. Can now lift arm above had but still feels very heavy. The lymph node glands under her left arm has reduced in size but still sore to the touch. I?ve been taking ibuprofen for the last two days to help with the discomfort.
54 2021-03-25 swelling face Immediate runny nose and terrible headache. After about 8 minutes, lip feeling weird. After 25 min... Read more
Immediate runny nose and terrible headache. After about 8 minutes, lip feeling weird. After 25 minutes of receiving shot, numb chest, neck, lower fac3 - and swelling of throat and lower face. The numbness and swelling lasted for approximately 3 hours.
54 2021-03-25 swelling The morning after the vaccine, I woke up with rash, swelling and inflammation everywhere that I have... Read more
The morning after the vaccine, I woke up with rash, swelling and inflammation everywhere that I have eczema and psoriasis. I took prednisone and the symptoms lasted about 24 hours.
54 2021-03-25 swelling Sore Arm, light swelling.
54 2021-03-27 lymph node swelling Mild sore arm x 2days , fatigue x2days and lymphadenopathy of bilateral axillae and swelling of righ... Read more
Mild sore arm x 2days , fatigue x2days and lymphadenopathy of bilateral axillae and swelling of right breast x5 days
54 2021-03-27 peripheral swelling High fever 103 to moderate fever 100 continuously over 48 hours. Pain at injection site immediately ... Read more
High fever 103 to moderate fever 100 continuously over 48 hours. Pain at injection site immediately after shot. Underarm swelling began at 36 hours after vaccine.
54 2021-03-28 anaphylactic reaction Acute anaphylaxis - throat closing. Given Benadryl.
54 2021-03-28 lymph node pain Sensitivity under right ear at lymph glands, no treatment; lasted two days
54 2021-03-28 lymph node swelling Enlarged lymph node under arm pit size of golf ball
54 2021-03-29 lymph node swelling Swelling in lymph nodes through out body- initially in groin then under both arms. Intense fever tha... Read more
Swelling in lymph nodes through out body- initially in groin then under both arms. Intense fever that broke in 3 hours, then ongoing fever and chills for 12 hours. 24 Hours later- still have swelling in lymph under left arm where injection was. By 56 hours post injection lymph still swollen and arm very sore.
54 2021-03-31 anaphylactic reaction March 31 - received vaccine and immediately within 2-3 minutes experience moderate anaphylaxis: Thro... Read more
March 31 - received vaccine and immediately within 2-3 minutes experience moderate anaphylaxis: Throat constricted, rapid heartbeat, hot flash, tingly face. But breathing was normal throughout. Within minutes was given EpiPen, followed by intravenous Benadryl. Then taken to ER to later receive steroids. Was observed in ER for 4 hours, with no reoccurrence of symptoms. Prescription for Prednazone (3 day course) and Benadryl (as needed). Epi Pen if needed. April 1 - Next day, felt totally normal. Slight soreness in arm, and very minor fatigue. was able to work, drive, and go about normal activities.
54 2021-03-31 peripheral swelling, swelling face Swelling of face and fingers. Redness to bilateral cheeks with noted mild puffiness. Benadryl 25mg P... Read more
Swelling of face and fingers. Redness to bilateral cheeks with noted mild puffiness. Benadryl 25mg PO given, another 25mg PO given 15 minutes later. Reported symptoms better. No swelling in face, decreased in hands 15 minutes after second dose of Benadryl.
54 2021-03-31 swelling Burning lips that day and then swollen, peeling lips for more than 1 mo after
54 2021-03-31 white blood cell count increased Thursday, March 18, 2021, 11:00 pm Around 12 hours after the vaccine, I started having stomach cramp... Read more
Thursday, March 18, 2021, 11:00 pm Around 12 hours after the vaccine, I started having stomach cramps and began having diarrhea. About an hour later (around midnight), I fainted while seated on the toilet and fell face first into the tiled floor. My forehead and mouth/teeth apparently broke my fall and I realized when I came to, I had chipped my two front teeth. There was a good amount of blood and soon after my house mates came to find me, they got me up to lean over the toilet as then I began getting sick and throwing up. They called the paramedics as I kept throwing up. The paramedics tended to me and after two does of an anti-nausea pill, I was able to at least keep a bit of water down. ....
54 2021-04-01 lymph node swelling, peripheral swelling Swollen arm and arm pit area with burning sensation intermittent. Still feel pain off and on after ... Read more
Swollen arm and arm pit area with burning sensation intermittent. Still feel pain off and on after 5 days in my armpit/breast area
54 2021-04-01 peripheral swelling Swelling, big lump in arm
54 2021-04-02 peripheral swelling Her temperature was 101 degrees; her arm is swollen; Dizzy; Lightheadedness; Nauseous; Shakiness; ar... Read more
Her temperature was 101 degrees; her arm is swollen; Dizzy; Lightheadedness; Nauseous; Shakiness; arm swollen; back hurts; hot where she got the injection; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0142), via an unspecified route of administration on Left arm on 08Feb2021 at single dose for covid-19 immunisation. Medical history included Flu on an unspecified date. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), at single dose for covid-19 immunisation. The patient reports, she received her second shot yesterday and her arm hurt like any shot would. She says today she feels really sick, after being fine yesterday. She says today she is dizzy and lightheaded. She says she took Advil, her temperature was 101 degrees Fahrenheit even with Advil, and every time she gets up she feels lightheaded and shaky. She says her back hurts when the Advil wears off, it is ok now because she is laying down, and she also feels a little nauseous. She says that her arm is swollen and hot where she got the shot, and this started today. She says that yesterday it just hurt like she got the flu shot. She says that she took Advil 200mg, she took two of them this morning at 06:00AM or 07:00AM, and then two more at 01:00PM. LOT: DY3057, EXP: May2023. She says by 11:00AM her fever was 101 degrees Fahrenheit, and now with the Advil it is 100.7 degrees Fahrenheit. Caller says that her lightheadedness and shakiness feel about the same. The seriousness was reported as non-serious. The outcome of the events unknown. Information on the lot/batch number has been requested.
54 2021-04-03 lymph node swelling High Fever (103); chills; body aches; headache; nausea; fatigue; pain at injection site; injection s... Read more
High Fever (103); chills; body aches; headache; nausea; fatigue; pain at injection site; injection site swelling and redness; lymphadenopathy; injection site swelling and redness; This is a spontaneous report from a contactable consumer(patient). A 54-year-old female (non-pregnant) patient received second dose of BNT162B2 (Solution for injection, Lot number: EL9269, Expiration date: unknown), in left arm on 11Feb2021 at 03:30 PM, at single dose for COVID-19 immunization. The patient historical vaccine included first dose BNT162B2 (lot number: EL8982) left arm on 21Jan2021, at single Covid-19 immunization. Patient medical history and concomitant medications were not reported. After second shot Patient experienced High Fever (103), chills, body aches, headache, nausea, fatigue, pain at injection site, injection site swelling and redness, lymphadenopathy on 12Feb2021 at 09:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was recovered.
54 2021-04-03 swelling face, lymph node swelling Initially rapid heart rate for 15 min then back to normal. later was tired, went to bed early woke... Read more
Initially rapid heart rate for 15 min then back to normal. later was tired, went to bed early woke up at 2 am and had swelling in face, throat and swollen eyes. Took Pepcid for itchy eyes. In the morning took Benadryl and slept on April 2. Hours later, most of the swelling was gone. Felt like a cold was coming on, running eyes, running nose, sneezing and loss of taste. 48 hours later, cold symptoms linger feeling tired. Still feel some swelling in the glands on neck .
54 2021-04-05 c-reactive protein increased Rash
54 2021-04-05 lymph node swelling, swelling face Symptons: swollen face, lips, eyes, lymph nodes, rash on face, bad itching on face, extremely dry f... Read more
Symptons: swollen face, lips, eyes, lymph nodes, rash on face, bad itching on face, extremely dry face and lips Treatment: steroid shot and steroid pack and Benadryl tabs as needed for itchy
54 2021-04-05 swelling face Patient waited 15 minutes and then left the store. about 30 minutes later the patient called the pha... Read more
Patient waited 15 minutes and then left the store. about 30 minutes later the patient called the pharmacy stating her tongue started to tingle and her face was starting to swell.
54 2021-04-06 lymph node swelling, swelling face After 2nd covid vaccine: 18-24 hours body aches; 36 hours swollen lymph node under right arm pit wh... Read more
After 2nd covid vaccine: 18-24 hours body aches; 36 hours swollen lymph node under right arm pit which lasted 2-3 days (same arm as vaccine). Also, sporadic sharp pain in left groin/pubic area that started approximately same time lymph node under armpit was swollen. Still getting sporadic sharp pains today (4/7/21) but armpit no longer sore or swollen.
54 2021-04-07 swelling Arm pain, redness, swelling, severe headache, fatigue, muscle soreness, chills.
54 2021-04-08 oral herpes The day after had fever, chills, headache, dermal pain, aches, could not smell, and fever blisters i... Read more
The day after had fever, chills, headache, dermal pain, aches, could not smell, and fever blisters in mouth. The fever has improved, dermal pain went away, still has headache, body is soar, fatigued, and cannot smell. to stay home form work until 10 days from onset of symptoms due to the fact that we are not sure if it is covid or not.
54 2021-04-08 peripheral swelling They began as red bumps on both arms when I woke up the following morning. The majority of the red ... Read more
They began as red bumps on both arms when I woke up the following morning. The majority of the red bumps/hives were on the left arm where I got the shot. The left arm was sore and slightly swollen. They bumps/hives became itchy and some spots spread and were raised up with a leathery appearance. I took Benedryl capsules for the first week, but became disoriented and dizzy, so stopped taking it. Used calamine and aloe vera as topical treatments. It is now 11 days from the first vaccine and I'm down to only 6 red hives on the left arm and 3 on the right arm. The right arm does have a large rash where I have scratched the hives and there is a quarter size rash has developed.
54 2021-04-08 peripheral swelling Systematic Inflamation 7 days post injection. Swollen hands/feet (10 days), Hiccups, stomach crampin... Read more
Systematic Inflamation 7 days post injection. Swollen hands/feet (10 days), Hiccups, stomach cramping (no nausea or diarrhea ), neck nerve pain that went behind shoulder blade (couldn't move for 3 days), bubbles in the back off my mouth after eating (looked like big blisters filled with fluid but never popped). Low blood pressure (99/65), low body temperature with chills (95.3F), dizzy on standing, blue finger tips loss of balance all lasting 1 day (most likely caused by mild reynod's). Subsided by day 17.
54 2021-04-08 swelling Swelling of lips, tongue and neck within 15 minutes of injection. Was monitored for 30 minutes. Sw... Read more
Swelling of lips, tongue and neck within 15 minutes of injection. Was monitored for 30 minutes. Swelling did not progress and went down throughout the day. Lost sense of taste for a day. Arm became very sore the day after receiving injection. Felt like I had the flu in that one arm. Pain was a 7 on 1-10 pain scale with 10 being the worst. Arm continues to hurt from 3 inches above elbow up to shoulder joint to this day. After receiving 2nd shot in right arm on 01/09/2021, the left hurt worse than the right arm. The right arm did not hurt immediately after the shot like the left one did. I can pinpoint and place my finger on the place I received both injections still. Both continue to hurt in the same areas up my forearms.
54 2021-04-08 swelling 2nd day swollen red lumps , very itchy all over body from the neck down, chest, stomach, arm thighs,... Read more
2nd day swollen red lumps , very itchy all over body from the neck down, chest, stomach, arm thighs, calf for 5 days, with mild itching lingering and redness after 5 days, swelling went down after 5 days
54 2021-04-09 anaphylactic reaction Anaphylaxis - hives, sensation of throat tightness, shortness of breath, sweating, hypertension, tac... Read more
Anaphylaxis - hives, sensation of throat tightness, shortness of breath, sweating, hypertension, tachycardia Treated immediately at vaccine site with epi-pen, Benadryl 50mg with improvement in symptoms. Transported to the ER where symptoms subjectively were returning and treated with famotidine 30mg and IV Solumedrol 125mg. Monitored for 3 hours further in the ER and discharged home with prednisone taper and prescription for Epi-pen.
54 2021-04-09 lymph node swelling, lymph node pain Swollen lymph node - significant swelling and pain. Swelling lasted through the 2nd vaccination and ... Read more
Swollen lymph node - significant swelling and pain. Swelling lasted through the 2nd vaccination and the pain in the lymph node lasted for a week.
54 2021-04-09 lymph node swelling SUPRACLAVICULAR ADENOPATHY - SWOLLEN, TENDER LEFT SHOULDER, NECK, EARACHE, TOOTHACHE
54 2021-04-11 lymph node swelling Lymphadenopathy or lymph node enlargement below left ear. Took ibuprofen for pain.
54 2021-04-13 lymph node swelling Received the shot in my left arm on March 27, 2021. By 4:30 p.m., on March 28, 2021, I had a fever ... Read more
Received the shot in my left arm on March 27, 2021. By 4:30 p.m., on March 28, 2021, I had a fever of 102.4, aches, headache. March 29, 2021, woke up and took a shower and noticed my left lymph node was swollen (size of half a grapefruit. No pain or heat coming from the area. Was still swollen on March 30, 2021 and placed a call in for the doctor to contact me. The doctor contacted me on March 31, 2021 and I was placed on an antibiotic. The swelling went down in my lymph node in a few days from starting the antibiotic. I am still not feeling well, low energy and breathing is not right. Deep breaths are difficult and still have body aches.
54 2021-04-13 lymph node swelling swollen nodes under the arm persisting after 3 days
54 2021-04-13 peripheral swelling, axillary mass Two days following the shot, I had swelling and a lump in my right armpit. The following week, 7 or... Read more
Two days following the shot, I had swelling and a lump in my right armpit. The following week, 7 or 8 days following my vaccination, I started experiencing chest discomfort to the left of my sternum. This continued for 4 days and then seemed to start getting better by day 5 so I did not seek treatment but was concerned it could be heart or lung issue. A few days after I began to experience swelling and tenderness in my left armpit which later went away.
54 2021-04-13 peripheral swelling At site location ; COVID19 Vaccination, 1st shot light headache for a day. second shot symptoms of m... Read more
At site location ; COVID19 Vaccination, 1st shot light headache for a day. second shot symptoms of mild headache for 2-3 days, right arm sore for a few days, both feets swollen with red rashes top of both foots. (right top foot darker rash). Still have swelling on both foot.
54 2021-04-14 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Medium, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium, Addi... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium, Additional Details: temp within normal range, BP 149, 146, then 161. had a fast heartbeat so drink 2 small water bottle and shaking hands a liitle.\r\npharmay monitored her more than 1 hour and 30 minutes. she is ok to go home. (previous event happened on last december d/t epinephrine inj at dental office)
54 2021-04-14 lymph node swelling, lymph node pain Severe joint pain in lower body, fever 101.4 lasting 48 hours; visibly swollen and painful lymph nod... Read more
Severe joint pain in lower body, fever 101.4 lasting 48 hours; visibly swollen and painful lymph node above collar bone on right side; no appetite for 24 hours; slight cough, abdominal pain/cramping beginning after 48 hours; headache; malaise; sore arm at injection site. Unable to go to work for three days (and counting).
54 2021-04-14 lymph node swelling Lymph node swelling came up on the left side of neck/collarbone. Noticed very early Monday morning, ... Read more
Lymph node swelling came up on the left side of neck/collarbone. Noticed very early Monday morning, 03/29/21. Today, 04/15/21, the swelling is almost gone.
54 2021-04-14 peripheral swelling Got the vaccine, shortly after that had a feeling of having a novocaine shot numbing feeling from he... Read more
Got the vaccine, shortly after that had a feeling of having a novocaine shot numbing feeling from her right side of her arm, her shoulders, head/neck, and then to the left arm. This then passed. That evening she was tired, sleepy and then the next day she had a bad headache. (possibly related to menstrual cycle beginning). She took Excedrin for that and when she woke up the 2nd day she was fine. Then on 4/12/21 she had her hair pulled up and reached the back of her neck and felt a pimple like feeling on the back of her neck. She then had her daughter look at her neck who informed her that she had a red rash, squeezed it and it popped and then noticed she had several on her neck. She then had the numbness return that she had on the right hand side of her face, her arm and a little down her leg. She went and got some Vitamin E ointment and rubbed it on the back of her neck, which seemed to resolve the rash eventually. Then that numbness feeling went away within an hour or two. The following night she also had recurrence of the same events from the previous day. Last night 4/14/21, she had the rash again on the back of her neck, and had actually moved down into her back area, down to her shoulder blade the same pimply type rash, and numbness down her side. She now has the same feeling around her ear area. She tried again the vitamin E ointment which did not help anything. She then took a Vitamin D pill which did not seem to do anything either. She woke up multiple times during the night as she still had the feeling and did not go away. When she woke up she felt sort of okay, has the rash, had the feeling of having had a headache/achy feeling, and can feel the rash on the back of her neck again. She has a call into her doctor to see if she can be seen. She has also noticed that her right arm had some swelling around the elbow area, but last night's episode she could definitely tell that it was swollen and the skin tight in the upper inside of the elbow and up to about the armpit.
54 2021-04-15 lymph node swelling Pain that started at deltoid now very strong in armpit. Caller took 1000mg of APAP to treat pain. 4/... Read more
Pain that started at deltoid now very strong in armpit. Caller took 1000mg of APAP to treat pain. 4/14-Caller called back and stated has mild - moderate axillary lymphadenopathy . She has taken Tylenol 1 g Adv: Usually symptoms are resolved within 48 hours, she can try and put some cold compresses on and off and take OTC NSAIDS , like Motrin if she is not allergic to it. Call us back with any questions. PCC will f/u 4/15-patient states that fever has come down. feeling much better.
54 2021-04-15 lymph node swelling unbearable itching, wheezing, shortness of breath, extremely swollen lymph nodes
54 2021-04-15 peripheral swelling woke about 5am day after receiving 2nd shot with pain at injection site, headache, swelling /pain un... Read more
woke about 5am day after receiving 2nd shot with pain at injection site, headache, swelling /pain under left arm, pain/ache in left leg, and redness and hardness around injection site. I took two doses of aspirin and one dose of cold & flu medicine during the day (4/7) and one dose of liquid cold & flu medicine before bedtime. 4/8 - fever and headache gone, still have the rest of the side effects, took aspirin at bedtime for leg pain. 4/9 - still have rest of side effects, took aspirin at bedtime for leg pain. 4/10 -4/12 - leg pain gone, still mild pain at injection site and underarm still swollen with mild pain. 4/13 - all side effects gone.
54 2021-04-16 peripheral swelling Swollen armpit towards the front, only hurts with certain movements of that arm.
54 2021-04-16 swelling face Patient received her 1st dose of Pfizer. Patient stated that se began to feel her face swelling. I... Read more
Patient received her 1st dose of Pfizer. Patient stated that se began to feel her face swelling. I asked her to remove her mask and could see the her face, mouth and tongue was swollen and she was tachypneic. I called a Nurse Alert (Rapid Response) and the Nursing staff brought the emergency kit. 911 was called by another nurse. Epi and Benadryl were administered intramuscularly. Patient was placed on continous pulse ox and vital sign monitoring. O2 was given to the patient. Clients vitals began to stabilize despite the continued swelling of her mouth and tongue. Firetruck arrived at 733pm and the ambulance arrived approx 3 minutes later. Patient transported to the hospital accompanied by her spouse.
54 2021-04-18 lymph node swelling, swelling face She got the vaccine, and got a racing heart, tightness and heaviness in her chest immediately. When... Read more
She got the vaccine, and got a racing heart, tightness and heaviness in her chest immediately. When she got to the nurse she relayed that to her. Later she felt unwell, and that her heard in a vice. She then went to the restroom and noticed swelling immediately under eye, and spread to the top of her checked and became dizzy around 1:00 AM that morning. Her lymph does swell and had to see a doctor a week later. Her doctor did an EKG, chest x-rays. She could not rid of the tightness of chest that would not go away. She gave her anti-inflammatory medicines and gave her a script for new inhaler, and is still having the tightness of the chest now. This was not on and off and had to see a doctor. She is taking her inhaler and taking Benadryl as she is now break and can't afford to go back if she has a problem. She got really, really ill and had 10 of the possible effects and then got the severe side effects. With the swelling, breathing difficulty and swelling of the face was advised not to get the 2nd vaccine. She told the nurse at the vaccine site what she was experiencing and was informed by her that it was pre-vaccine anxiety and was dismissed.
54 2021-04-19 lymph node swelling supraclavicular lymph node enlargement
54 2021-04-20 fluid retention I did not see or feel the pharmacist insert a needle into my arm. What I saw was a square little box... Read more
I did not see or feel the pharmacist insert a needle into my arm. What I saw was a square little box pressed against my skin and then she said it was done. I felt absolutely nothing and was surprised that the injection had been administered. The day after I felt all right just a very sore arm. But the following day some side effects started occurring which still have not gone away after three weeks. Severe fatigue not able to function at normal level, exercise I can only do about a third what I usually do. Brain fog. Listlessness. All muscles and joints achy and burning all of the time, skin flaring up red, sensation of systemic inflammation. Tremendous water retention, picked up about 7 pounds without any dietary change. Urination is scant even though I drink about 64 ounces of water a day. Stool is a lot less than it used to be, and I?m usually very regular . I wake up very groggy and tired in the morning. Very heavy sensation in the body. What I should mention is that I was about 80 pounds overweight and tests showed heightened inflammation markers two years ago. Since then I lost about 30 pounds on a high-protein diet with 4 to 5 times a week exercising and strength training. The heightened inflammation disappeared as well as the chronic tinnitus in 2018. . Two days after I had the vaccine, all my inflammation symptoms tinnitus, water retention and weight gain returned, despite no change to my diet or exercise regime.
54 2021-04-20 peripheral swelling My upper/mid left arm, is very swollen. It has been since the day I received the vaccine-happened al... Read more
My upper/mid left arm, is very swollen. It has been since the day I received the vaccine-happened almost immediately. My arm is also very painful, tingly, all the way down to the fingers. This swelling and pain has not subsided at all, since I received the vaccine. I went to the hospital the same evening. I was given an antihistamine, Ibuprofen, and ice, and told there was nothing more they knew to do. A week later, I went to my former family physician, and was given an antibiotic for a week. (do not remember the name). Nothing changed after a week so on Tuesday, April 20, I went to the ER. They gave me a test to check for a blood clot, as well as a Percocet pill and an hour after a shot of Morphine. There was not evidence of a blood clot, and I came home. There is still swelling today, though now I have a course of Wal-Dryl, 25 mg Allergy caps , 24 pills. 1 every 4 hours, a course of Prednisone, 20 mg, 20 pills, and oxycodone/Acetaminophren 5-325 mgs for pain, 18 caps, 1 every 4 hours. I have also called the County Health Department who advised to see an Infectious Disease Doc. I am still in pain, and swollen. I haven't had a fever, but am feeling warm, tired and achy.
54 2021-04-20 swelling face Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of ... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Excessive Salivation-Severe, Additional Details: Patient reveived vaccine at 10 AM, left store around 10:15, and noticed symptoms beginning at 10:35 upon arriving at home. Pt only called her physician after the weekend, but mentioned her symptoms were subsiding Sunday eve into Monday morning. Pt has lupus and believed this was initially at problem with her lupus, but physician office says this could have been a reaction to the vaccine
54 2021-04-21 lymph node swelling Sudden onset of enlarged, swollen, lymph nodes in underarm and clavical area.
54 2021-04-22 lymph node swelling Fever over 100; extreme soreness in whole body, horrible headache, swollen lymph node in left armpit... Read more
Fever over 100; extreme soreness in whole body, horrible headache, swollen lymph node in left armpit, difficulty moving left arm
54 2021-04-23 lymph node swelling pain; swelling of left axillary lymph node; This is a spontaneous report from a contactable consumer... Read more
pain; swelling of left axillary lymph node; This is a spontaneous report from a contactable consumer (patient, self-reported). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN 5318 and expiration dates were not reported), via an unspecified route of administration in left arm on 12Feb2021 at 12:30 PM, as single dose for COVID-19 immunisation. The medical history included R hip arthritis and allergy codeine causes nausea and vomiting. The concomitant medication included naproxen, ibuprofen, calcium, vit D and glucosamine. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL 9261 and expiration dates were not reported), via an unspecified route of administration in right arm on 21Jan2021 at 06:30 PM, at single dose for COVID-19 immunisation. On 13Feb2021 at 12:00 PM, patient experienced pain and swelling of left axillary lymph node. No any other vaccine administered in four weeks. The corrective treatment was not required for the AE. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the patients event was recovering.
54 2021-04-23 lymph node swelling Glandular swelling and discomfort near right armpit
54 2021-04-24 lymph node swelling pass out; sharp pain on the left side of her chest that continually got worse; it seemed muscle or l... Read more
pass out; sharp pain on the left side of her chest that continually got worse; it seemed muscle or lymph node related; This is a spontaneous report from a contactable consumer (patient) reported that a 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ep6955), via an unspecified route of administration, administered in arm left on 23Mar2021 15:45 (at the age of 54-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the Pharmacy/drug store. The patient was not pregnant at the time of vaccination. The patient medical history included Hashimoto's from an unknown date. The patient had known allergies to shellfish. The patient had no covid prior vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); vitamin c [ascorbic acid] (VITAMIN C); colecalciferol (VITAMIN D); cyanocobalamin (B 12); magnesium; and cetirizine hydrochloride (ZYRTEC); all were taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 16:30 45-minutes after getting the shot the patient had a sharp pain on the left side of her chest that continually got worse. It seemed muscle or lymph node related - and eventually got to the point where she couldn't easily move without feeling like she was going to pass out from the pain. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events included prescription pain reliever and muscle relaxant. The outcome of the events was recovered. The patient did not covid tested post vaccination.
54 2021-04-24 swelling face cheeks, chin and marionette lines/ swelling; bruising; cheeks, chin and marionette lines/ pain; chee... Read more
cheeks, chin and marionette lines/ swelling; bruising; cheeks, chin and marionette lines/ pain; cheeks, chin and marionette lines/ pain; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Mar2021 at single dose for COVID-19 immunization, started to receive hyaluronic acid, lidocaine (RESTYLANE L) from 23Mar2021 for unspecified indication. Medical history was not provided. Concomitant medications were not provided. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Patient injected to cheeks, chin and marionette lines with hyaluronic acid, lidocaine on 23Mar2021 and experienced swelling, bruising, and pain in Mar2021. Patient took Arnica, ibuprofen and applied ice; bruising resolved, other events were ongoing. Action taken with hyaluronic acid, lidocaine was unknown. Outcome of the event bruising was recovered while other events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
54 2021-04-24 swelling she woke up feeling like she was getting a cold; shivering; sweating; running a fever; feel uncomfor... Read more
she woke up feeling like she was getting a cold; shivering; sweating; running a fever; feel uncomfortable; armpit swelling and soreness; armpit swelling and soreness; arm being sore; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left (left upper arm, near the top of her shoulder) on 06Apr2021 14:00 (Batch/Lot Number: EW0151) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Her arm started to feel sore immediately after getting the vaccine on 06Apr2021. It stated that as the day went on, the soreness was getting more pronounced. When the syringe went in, she felt it, like it had crossed the cartilage or something. A few hours after that, the soreness was settling in and it was getting more sore. By the end of the day, it was more sore. Her arm was sore most of the day yesterday (07Apr2021) and was uncomfortable. Her arm is still sore today (08Apr2021) but not as bad as it was. Wednesday morning, yesterday, she woke up feeling like she was getting a cold, she was shivering. Yesterday, she spent the whole day in bed, shivering, and sweating, and running a fever. By the time she got to bed, she was feeling a little better so she thought she would be feeling better this morning. Her fever started yesterday mid-morning around 9:30 or 10:00 am. The fever lasted the whole day and subsided in the evening. She clarifies she may have a little bit of a fever now but she has not taken her temperature yet. If she does have one, it is very mild. In the middle of the night, she started to feel uncomfortable, like right under her armpit, it was sore. She woke up this morning and stated it was pretty noticeable, there was swelling kind of like under her armpit, but its more towards her chest a little. The area was very uncomfortable and very sore. She confirmed she started feeling the armpit swelling and soreness overnight last night. It's still very uncomfortable and sore. Treatment included she took 2 Acetaminophen pills, 500mg each, yesterday around 2pm and took 2 pills before going to bed last night around 8:00pm. The adverse events didn't require a visit to emergency room or physician's office. Patient had blood work in Mar2021 that showed that she had antibodies in her system. In Dec2020, patient's husband was positive for Covid and she was negative. The outcome of event feel uncomfortable unknown, armpit swelling and soreness was not recovered, the other events was recovering. No follow-up attempts are needed. No further information is expected.
54 2021-04-25 peripheral swelling Right arm badly hurting, pain and swelling in under arm and breast on the right side. Very very pain... Read more
Right arm badly hurting, pain and swelling in under arm and breast on the right side. Very very painful.
54 2021-04-26 lymph node pain, swollen extremities, lymph node swelling I noticed my left underarm was bothering me on Saturday night, a day after I received my 2nd shot. ... Read more
I noticed my left underarm was bothering me on Saturday night, a day after I received my 2nd shot. The lymph nodes were swollen and sore to the touch. Today is Tuesday, and it is still bothering me.
54 2021-04-26 peripheral swelling Presented to the ED on 4/25 with severe R calf swelling and pain x4-5 days. Found to have ACUTE THRO... Read more
Presented to the ED on 4/25 with severe R calf swelling and pain x4-5 days. Found to have ACUTE THROMBOSIS IN THE DEEP VEINS OF THE RIGHT FEMORAL, POPLITEAL, POSTERIOR TIBIAL, PERONEAL VEINS and ACUTE THROMBOSIS IN THE DEEP VEINS OF THE RIGHT CALF. Admitted for systemic anticoagulation and possible catheter-directed thrombolysis given extent of clot burden and symptoms.
54 2021-04-26 swelling Patient states she was experienced some swelling patrolled and feel like she?s gonna pass out. ENS w... Read more
Patient states she was experienced some swelling patrolled and feel like she?s gonna pass out. ENS was called, and patient was examined by one of the EMS personnel.
54 2021-04-26 swelling Decreased breathing, swelling from head to pelvis, broken blood vessels over entire torso, enlarged ... Read more
Decreased breathing, swelling from head to pelvis, broken blood vessels over entire torso, enlarged right side of throat, hard to swallow
54 2021-04-27 anaphylactic reaction Felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn'... Read more
Felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe; almost like she couldn't breathe/Difficulty Breathing; Felt funny in her chest, like a really weird, really warm and heavy feeling/ warm feeling in the chest; having an anaphylactic reaction from the vaccine; Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress; Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress; Very sore right arm where she was given the injection; felt like she was punched several times in her arm; Injection site bruising; This is a spontaneous report from a contactable nurse(patient). The nurse reported similar events for herself and her husband. This is the first of two reports. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 54 years of age), dose 1 intramuscular, administered in arm right on 10Mar2021 16:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included severe asthma which started as a child and then it went away and then as an adult it got severe around 2010 and ongoing, she was an asthmatic and would panic and start feeling worse. She had ongoing chronic obstructive pulmonary disease (COPD), brain surgery in 2007, low immune system, allergies to cephalosporins, pulmonary and stomach issues; and bradycardia (as her BP usually runs 90/45 and she is bradycardic). Concomitant medications included tiotropium bromide (SPIRIVA RESPIMAT), salbutamol sulfate (PROAIR HFA), fluticasone propionate, salmeterol xinafoate (ADVAIR HFA), salbutamol (VENTOLIN [SALBUTAMOL]), and montelukast (MONTELUKAST), all taken for asthma, chronic obstructive pulmonary disease from an unspecified start date and ongoing; clarithromycin (CLARITIN [CLARITHROMYCIN], omeprazole, phenytoin sodium, azelastine, ipratropium bromide, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), and ipratropium bromide, salbutamol sulfate (DUONEB), all taken for an unspecified indication from an unspecified start date and ongoing; prednisone taken for an unspecified indication from 2021 and ongoing as she was on this steroid 2 weeks before the vaccine; and azithromycin which she takes prophylactically for her low immune system from an unspecified start date and ongoing. She was on a lot of medications period and most are for her pulmonary and stomach issues. The patient previously took propofol, Versed, Nitrous Oxide, and Percocet wherein the patient had drug hypersensitivity and anaphylactic shock with these; adhesive from nicotine patch made her arm to get red and swollen (Dermatitis contact). She previously took EpiPen for anaphylaxis. It was reported that on 10Mar2021, the patient had the first dose of the vaccine and it felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe. She got her vaccine at a hospital in their clinic and she was transferred from the vaccine clinic to the ER. Stated she was given a shot with an Epi-pen in her thigh at the clinic and transferred to the ER. In the ER, she was given Benadryl and watched for 4 hours. She would state this was medically significant because of airway, breathing, circulation and she felt like she couldn't breathe. She added that it was kind of weird and freaky. She mentioned that along with that, shortly before she was released from the ER, she experienced a very sore arm where she was given the injection. She heard that was very common so she dealt with it. However as the night progressed, it got increasingly worse, it almost felt like she was punched several times in her arm. It probably started between hour 3 and 4 after receiving the vaccine. She added that she had a very sore right arm where she was given the injection; felt like she was punched several times in her arm. It was not serious, just annoying and it was gone 3 days later. She had injection site bruising on 10Mar2021. She stated that she knows this because she was a nurse, but a lot of times, people experienced this reaction when they are given Dilaudid wherein they get a warm feeling in their chest, so they push it really slow and dilute it with saline so it doesn't have the respiratory factor. She stated that this was kind of what the feeling was like for her and it was scary because she didn't expect it. She stated that the ER team that assessed her said, because she wasn't used to that feeling, she may have had a panic attack and that may have made it worse. After she was treated, she spoke with her husband and he had the shot two minutes before her and he had the same feeling but he didn't freak out and didn't want to appear weak. Stated he told her he had the same feeling and it lasted 5 minutes and then it went away. Stated since she got scared, it made it worse. She doesn't know if she had a panic attack that made it worse. She stated that of course her husband didn't tell her that until she was out of the ER, that it does go away. That made her feel better because she wasn't the only one that experienced that. States he didn't say anything about it, because he was worried about her, he said it was a warm feeling in the chest and not being able to breathe but he didn't want to say anything because she was an asthmatic and would panic and start feeling worse. She mentioned that they weren't going to let her get the second dose, so she went to an allergy doctor and told them what happened and about her husband having the same reaction and because she was severely immunocompromised. Stated the hospital said they were not giving her the second dose unless an allergist says it is safe and sets a protocol and he had to write a letter to the hospital. Stated she was pre-medicated 24 hours before the vaccine with 50mg Benadryl, 50mg Benadryl the day of the shot and 50mg of Benadryl two days after the shot. Stated she will have full immunity on 14Apr2021. She added that she had a pulmonary doctor, brain cancer doctor, ENT doctor, stated they don't know if it was caused by the vaccine, but they are pretty sure she had a reaction but they can handle it with pre-medicating her. She received the second vaccine on 31Mar2021. She mentioned that she was happy to be able to get her second shot. She stated that at first they didn't want to give it to her because of her reaction but she kept calling. So she went to a hospital to saw an allergist and he had to sign off that it was safe to give her the second shot and under what circumstances. Stated she had the letter from the hospital that she was seen by them and she needed to be pre-medicated and it had to be given at a hospital that had the ability to intervene quickly and she needed to be watched for at least 30 minutes after the vaccine. She mentioned that to go through what she went though, and not be able to get would have been disappointing. Because of her immune system, it is important to get the shot and there was a way around the reaction which worked for her. She added that even having an anaphylactic reaction from the vaccine, she was able to recover quickly. Stated with having asthma, COPD and a low immune system, she may not recover from Covid. It makes sense they evaluated it and came up with a solution and a pre medication protocol and when and how long and she was still able to get the shot because it is important. Answers to follow up questions indicated that on 10Mar2021, the patient had the first dose of the vaccine and it felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe. She was given the shot and getting ready to get out of the chair and her husband was about to sit down for his shot. Stated she would say the time of the course of the reaction was within under 5 minutes of her injection. The patient required medical intervention with Epi-Pen, Benadryl, and Duo-Neb. The patient was not hospitalized because she was immunocompromised, it was better to watch herself at home and because she had an Epi Pen at home in case she has that sort of reaction returning over a 72 hour period. Stated they instructed her husband and told them if she felt any different to come back to ER. She was not admitted to the ICU. Organ involvement included: Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress. The event required initiation of new medication or other treatment or procedure including Epi-Pen, Benadryl, DuoNeb. Patient have a history of previous allergies: Medication Allergies to Cephalosporins, Anesthesia medications: Propofol, Versed, Nitrous Oxide, Percocet: Anaphylactic shock; Adhesive from nicotine patch, caused her arm to get red and swollen. She takes EpiPen as she had previous history of allergies and since she had multiple medication allergies and had a history of quickly going into anaphylaxis, stated her BP usually runs 90/45 and she was Bradycardic. She did not receive any recent vaccines for any other conditions prior to the events being reported. She did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. She has not received any other vaccines around the time of the Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient recovered from 'felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe', Difficulty breathing, and 'warm feeling in the chest' on 10Mar2021; while having an anaphylactic reaction from the vaccine, Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress were recovered on an unknown date; Vaccination site pain recovered on 13Mar2021 and Injection site bruising recovered on 18Mar2021. Therapeutic measures were taken as a result of all events except Vaccination site pain and Injection site bruising. Relatedness of drug to reactions/events: Reaction assessed for events "felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe", 'very sore right arm where she was given the injection; felt like she was punched several times in her arm.' and Injection site bruising: Method of assessment: Global Introspection: Drug result: Related. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, the Company considered all serious and non-serious events as possibly associated to BNT162B2 injection, due to a plausible chronological sequence. Current patient conditions of asthma, chronic obstructive pulmonary disease and allergic diathesis may have been considered as favoring factors in development of reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2021406773 same reporter and drug, similar events, different patient
54 2021-04-27 axillary mass ?Pfizer-BioNTech COVID-19 Vaccine EUA: patient reports nausea, fever, headache, and axillary mass (p... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA: patient reports nausea, fever, headache, and axillary mass (painful, worsening, red, and unable to put arm down) after vaccination. Patient advised home management: antihistamines, topical steroids, ice (when able to tolerate) and to rest.
54 2021-04-29 lymph node swelling Patient had extremely enlarged lymph nodes in the crook of her neck. Her doctor told her it would su... Read more
Patient had extremely enlarged lymph nodes in the crook of her neck. Her doctor told her it would subside with time. She was not given any medication for it.
54 2021-04-29 peripheral swelling, swelling face Immediate redness in face (similar to Rosacea). Approximately 30 minutes later, swelling in face, ha... Read more
Immediate redness in face (similar to Rosacea). Approximately 30 minutes later, swelling in face, hands and feet, dizziness, and fatigue. Swelling in face, hands and feet, fatigue, fever x 3 days. Dizziness x1 day. Rosacea x1 day. Since vaccine, I have had bouts of shortness of breath, and occasional pain in my left breast area near the heart.
54 2021-04-29 peripheral swelling 04/19/2021 at 8:00am woke up with a very bad headache. Temperature of 101.2. Sat in dark room with i... Read more
04/19/2021 at 8:00am woke up with a very bad headache. Temperature of 101.2. Sat in dark room with ice bag on head and use of tylenol. Drank soda and sat quietly. 04/20/2021 7:30 am. Headache gone with fever. Left arm is now very swollen. Hot to touch. Itchy. Achy. And about a 4? wide rash band on my left arm near crease/ elbow. 4-29/2021 rash is still slightly visible but fading. No heat emitting from it.
54 2021-04-30 peripheral swelling brain fog; Mild Headache; swelling in hands; fever; joint pain; Extreme Fatigue/ severe fatigue; Diz... Read more
brain fog; Mild Headache; swelling in hands; fever; joint pain; Extreme Fatigue/ severe fatigue; Dizziness; This is a spontaneous report received from a contactable consumer (patient). This 54-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 14:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history, no known allergies to medications, food, or other products, had not been diagnosed with COVID-19 prior to vaccination and had not received any other vaccines within 4-weeks prior to the COVID vaccine. The patient had no concomitant medications. On 30Mar2021 at 19:00 the patient experienced extreme fatigue and dizziness four hours after vaccination; six hours post-vaccination the patient experienced mild headache, swelling in hands, fever, and joint pain. The patient further reported the next day she had mild hand swelling, severe fatigue, brain fog and mild joint pain. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of extreme fatigue, dizziness, mild headache, swelling in hands, fever, joint pain, and brain fog were recovering. It was also reported the patient had not been tested for COVID-19 since vaccination. No follow-up attempts are needed. No further information is expected.
54 2021-05-02 lymph node swelling Swollen Lymph Nodes on Right side of neck. Stiffiness to neck and tenderness to touch on Right side... Read more
Swollen Lymph Nodes on Right side of neck. Stiffiness to neck and tenderness to touch on Right side of scalp and neck as well as inside of Right elbow. Moderate to Sever Headache mostly on Right side of head and back of Right eye, low grade fever from 99 to 101.7, Doctor stated to take Ibuprophin 3 times a day, this has provided mild relief of the pain. The tenderness on the neck makes it difficult to sleep. I have been using an icepack to help relieve the pain on the neck and head with some relief on pain.
54 2021-05-02 peripheral swelling Right foot pain/swelling, redness. could not walk, could not tolerate any weight on foot. Today is... Read more
Right foot pain/swelling, redness. could not walk, could not tolerate any weight on foot. Today is 5/3 and still have slight pain.
54 2021-05-03 fluid retention FIRST VACCINE GAVE ME A SORE ARM, TEMPORARY FLU LIKE SYMPTOMS (48 HRS) AND MADE ME CRY UNCONTROLLABL... Read more
FIRST VACCINE GAVE ME A SORE ARM, TEMPORARY FLU LIKE SYMPTOMS (48 HRS) AND MADE ME CRY UNCONTROLLABLY. SECOND VACCINE GAVE ME A SORE ARM, RINGING IN MY LEFT EAR THAT LASTED 30 MINUTES IMMEDIATELY AFTER VACCINE, FEVER, SEVERE BODY ACHES THAT MOVE AROUND MY BODY AND ARE ONGOING (6 WEEKS SO FAR), HEADACHES AND MIGRANE HEADACHES DAILY. (ONGOING 6 WEEKS SO FAR). I ALSO HAVE LOTS OF WATER RETENTION AND UNSURE IF THAT IS PART OF THE VACCINE OR NOT. I ALSO HAVE SEVERE PAIN IN MY LOWER LEFT ABDOMEN THAT MAY OR MAY NOT BE RELATED. IM ALSO VERY TIRED, BUT THAT MAY BE DUE TO THE ONGOING PAIN I FEEL DAILY.
54 2021-05-04 anaphylactic reaction I had mild anaphylaxis immediately after receiving the second dose. I did not make too much of it as... Read more
I had mild anaphylaxis immediately after receiving the second dose. I did not make too much of it as I have a lot of allergies and carry an epi-pin that I have never had to use. Approximately an hour later I suspect I had a seizure at home. I got my allergy shots yesterday 3/5/2021 and approximately an hour later I started having the same sort of "spells" for a lack of a better word that persisted through the night. The same exact feeling as the second vaccine injection without the anaphylaxis.
54 2021-05-05 pancreatitis Pancreatitis confirmed by lipase >40,000 and CT imaging. Symptoms began on 4/30/21, which was 6 days... Read more
Pancreatitis confirmed by lipase >40,000 and CT imaging. Symptoms began on 4/30/21, which was 6 days following vaccine administration. The patient was hospitalized for 5 days and discharged in good condition. No cause was identified of pancreatitis. Patient has no history of pancreatitis and does not drink alcohol.
54 2021-05-06 lymph node swelling Soreness in my arm at the injection site, pain/burning along a vein leading up to left side of my ne... Read more
Soreness in my arm at the injection site, pain/burning along a vein leading up to left side of my neck and shoulder, swelled lymph node along my left collar bone, 3-4 smaller swelled lymph nodes along my left shoulder cap, fatigue , nausea, headache and diarrhea
54 2021-05-06 peripheral swelling Mild Itching of fingers and injection site 10 minutes after injection. Moderate itching of hands, fe... Read more
Mild Itching of fingers and injection site 10 minutes after injection. Moderate itching of hands, feet, and neck area. throughout rest of evening. 3AM no more itching, nausea, felt feverish, ( highest temp 99.9) arm very sore took Tylenol every 4 hours. Thurs AM, hot and cold chills throughout the day, entire arm very sore, hands and feet red, hot, swollen, arthritis very painful, Tylenol helpful. Slept most of day and night, felt like I had not slept in days. Friday symptoms persist but beginning to subside.. as of 5:18 PM symptoms light and tolerable. Swelling in hands and feet almost normal, not as tired, body temp fine, only very slight headache occuring.
54 2021-05-07 lymph node swelling Lump in (left side) of neck. I felt fine. Felt lump in neck at 4:30pm Friday May 7,2021. It was ab... Read more
Lump in (left side) of neck. I felt fine. Felt lump in neck at 4:30pm Friday May 7,2021. It was about the size of an almond. Over the next 5+ hours it grew. Went to the ER 10:30pm. EKG , CT scan, blood work. Discharged 6:30am May8, 2021.
54 2021-05-07 white blood cell count increased all side effects still happening and have been for over a month breast pain (have implants from 1... Read more
all side effects still happening and have been for over a month breast pain (have implants from 1999 and have hysterectomy since 15 years ago) weight gain fatigue infection in body, mostly in bladder area but at this point unidentified blood results all significantly off from recent CBC tests done in 2021 lymphocytes, monocytes, WBC high RBC low, sodium low glucose high, basophils (have at least 4 results to compare to over past 6 months, cbc and chem panel) low tsh headaches heart issues tightness hypertension trouble breathing
54 2021-05-08 lymph node swelling Fatigue on first day (Wed) 2 hours after through 72 hours, muscular aches 18-72 hours after, fever 1... Read more
Fatigue on first day (Wed) 2 hours after through 72 hours, muscular aches 18-72 hours after, fever 100.9 around hour 24, chills hours 24-30 after, fever dropped to 99 on Fri-Sat, swollen lymph node under L arm 48 hrs after & continuing, lymph node swollen L collar bone area 72 hrs after & continuing.
54 2021-05-09 lymph node pain Within 23 to 24 hrs of 1st shot, felt faint and legs wobbly. Lied down on kitchen floor with legs ra... Read more
Within 23 to 24 hrs of 1st shot, felt faint and legs wobbly. Lied down on kitchen floor with legs raised for about 5 to 7 minutes. Then within an hour had chills and a fever of 100.1, took Tylenol, then had hot spells. Went to bed about 830pm. Next morning felt fine except for soreness in left underarm, lymph node area in addition to slight pain in injection site. 4 days later underarm less pain but still slight pain at injection.
54 2021-05-10 bursitis Bursitis; pain to hip joint/Left hip pain; numbness to hand and fingers; numbness to hand and finger... Read more
Bursitis; pain to hip joint/Left hip pain; numbness to hand and fingers; numbness to hand and fingers; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER2613) intramuscular, administered in arm left on 25Mar2021 at 13:25 (at the age of 54-years-old) at a single dose for covid-19 immunisation. Medical history included ongoing asthma diagnosed 4-5 years ago, sjogren's syndrome 11 years ago, systemic lupus (came right after the sjogren's disease), rheumatoid arthritis (in october eleven years ago), fibromyalgia 11 years ago, blood disorder 11 years ago. she cannot think of the other one. There is another breathing one that starts with a C and she does not remember the name of it. She does not have diabetes. She has autoimmune diseases. She has a weird birth defect but did not feel it was relevant. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Lot EN6205) on 03Apr2021, injected intramuscularly in right arm for covid-19 immunisation. The patient experienced pain to hip joint, numbness to hand and fingers in Mar2021 and Bursitis on an unspecified date. It was reported that the patient had second shot on 25Mar2021, and not long after she started experiencing Left hip pain and was not sure what she had done to it. When she saw her rheumatologist, she did an X-ray and found she had bursitis of her left hip. She has also been experiencing problems in her fingertips and toes. She did not realize it until she went through paperwork that they give you that on their it says bursitis of left hip and hand and foot pain is a side effect. She wanted to know if this was all related and if others have had this. Her rheumatologist is sending to neurologist and wondering if she needed to go there or not, or if it is related to the vaccine. She said she grabbed her infusion card. She has been on the same medications for 11 years and did not feel they were relevant. She first had the X-ray of hip and back 2 weeks ago. It showed compression fractures in back and bursitis in left hip. She already had the compression fractures previously diagnosed about 9 years ago. She went to the ER a few days after that for follow up and they did another X-Ray. It did not show any changes. When she went back to her Rheumatologist, she gave her a Bursa shot in left hip. They also sent to emergency room for that. The pain was awful, she could not get into the bed. No additional Vaccines was administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not experience adverse event following prior vaccinations. The patient underwent lab tests and procedures which included Xray of hip and back: bursitis on xray of hip: showed bursitis on left hip, x-ray: Xray of hip Showed Bursitis on left hip and Xray of back showed compression fracture on back. The outcome of the events pain to hip joint, numbness to hand and fingers was not recovered and was unknown for the event Bursitis. No follow-up attempts are needed. No further information is expected.
54 2021-05-10 swelling 3 weeks after 1st vaccine starting 4/10/21, I developed weird and painful swelling, bright red with ... Read more
3 weeks after 1st vaccine starting 4/10/21, I developed weird and painful swelling, bright red with blisters on my right baby toe. Saw a Dr. podiatrist on 4/15/21. He hadn't seen anything like this...but treated it as a staph infection and put me on Sulfamethoxaz-ole-tmp DS for ten days. ( I received 2nd injection COVID vaccine on 4/13/2012)... I needed to fly out of state 4/19/2012 for a family issue ..toe wasn't improving. could not wear enclosed shoe on that foot, swelling on toe so bad that it caused the skin to spit open in several sites and small area of black was at the top of toe from blood. I saw a dermatologist on 4/20/2021 Dr. Solis in Westerly RI and he felt that the antibiotic was doing its job. The blisters had disappeared and even tho still very swollen it was starting to heal. Recommended finishing up the antibiotic that Dr had put me on. It slowly improved and by 4/30/2021 was much better but never completely returned to normal. On 5/7/2021 it came back again..blisters, red and swollen. Saw Dr. on 5/10
54 2021-05-11 lymph node swelling Shingles on left side trigeminal nerve with headaches, rash and swollen left eye, swelling in nymph ... Read more
Shingles on left side trigeminal nerve with headaches, rash and swollen left eye, swelling in nymph nodes
54 2021-05-11 swollen extremities Reported generalized edema on face and hands. She was noted to have some flushing. She called 911 an... Read more
Reported generalized edema on face and hands. She was noted to have some flushing. She called 911 and was brought to ED for treatment. She received IV fluids and antihistamine in the ER. She was discharged the next day and was presccribed an antihistamine for 5 days. She is fully recovered.
54 2021-05-12 bursitis I had my first shot on Dec 22nd, 2020. I had my second shot on Jan 12th 2021. On May 7th, 2021 I st... Read more
I had my first shot on Dec 22nd, 2020. I had my second shot on Jan 12th 2021. On May 7th, 2021 I started a period 6 years or so menopaused. This is not normal. I am seeking treatment from my OB dr. 2 weeks after the 2nd shot, I noticed my shoulder was not getting much better, it was achy still. I started to have more shoulder pain. It has continued to get worse. I now have been diagnosed with bursitis at the place where they inserted the needle for the 2nd shot. It continues to alter my way of life, as It is hard to get ready in the morning, and also hard to use my arm to pick things up and bring back to me. So extending my arm out in front of me and brining it back, to drink a cup of coffee gives me much pain.
54 2021-05-12 swelling face Within a couple of days, my vision was blurry and I felt like there was something in my eyes. They w... Read more
Within a couple of days, my vision was blurry and I felt like there was something in my eyes. They were irritated and didn?t respond to allergy drops or artificial tears. Around 5/6/2021, I noticed a bump/swelling on my left eyebrow. It was tender, and continued to swell for days. Approx. 5/10 I noticed some other bumps on my face and forehead. I began to feel shooting pain into my scalp, and i would be awakened by the throbbing in my eye and brow.
54 2021-05-13 swelling 1 Inch below the actual injection site began a quarter size red, swollen, painful spot. By end of 5/... Read more
1 Inch below the actual injection site began a quarter size red, swollen, painful spot. By end of 5/13/21 had become the size 4 inch x 1.5 inch oval. Went to Emergency Room to make sure was not a blood clot. Doctor said was not a blood clot. He also did ultrasound to make sure no abscess or other was present. Nothing present. Prescribed antibiotics for Cellulitis but I have not started that treatment.
54 2021-05-17 lymph node swelling 102 degree fever starting about 15 hours following the 2nd dose (last about 24 hours) Chills Body ac... Read more
102 degree fever starting about 15 hours following the 2nd dose (last about 24 hours) Chills Body aches Fatigue/tiredness Swollen lymph nodes (armpit under injection site)
54 2021-05-19 peripheral swelling Swollen, red on the base of the hands.
54 2021-05-23 lymph node swelling On the evening I received my shot I ran fever, my body ached terribly my from my neck down and BOTH ... Read more
On the evening I received my shot I ran fever, my body ached terribly my from my neck down and BOTH epitrochlear nodes located on the inside of my elbows were swollen (large - like small round balls). The right side was larger than the left one. They are still swollen today. I have not seen a doctor.
54 2021-05-23 swelling Approximately 1 month after receiving both phizer vaccines I began having a sore throat. I went to u... Read more
Approximately 1 month after receiving both phizer vaccines I began having a sore throat. I went to urgent care who referred me to a hospital which evaluated me as having an abscess on my throat which made my neck swell. They treated me with a dose of dexametasone intravenously and sent me home with augmentin 875mg. I took the medication as prescribed and after 8 days I?m finally feeling better. I believe that the vaccine may have weakened my immune system to where I caught the sore throat. I am still practicing the CDCs guidelines wearing masks, washing, hands and social distancing because although I?m fully vaccinated I don?t want to contract the virus.
54 2021-05-23 swelling Itching began on Tuesday May 18 at 10pm on my thighs; then itching continued to back of the legs and... Read more
Itching began on Tuesday May 18 at 10pm on my thighs; then itching continued to back of the legs and knees with a slight swelling feeling. So much that I needed to look and see if I had gotten bit or something. I changed out of jeans and then saw my legs had developed rashes in large sections; some looked like hives, some like little red bumps, some with just read splotches. I washed my legs thinking maybe a bug or allergen and put anti itch cream on one leg to see if it would help or if I needed anything else. I went to bed shortly after and then woke at 6am (Weds. May 19) and when I changed out of pj's, noticed rashes also at the injection site; the itching continued to come and go and when it would begin to itch, the rash/bumps would appear without scratching. The rashes would continue on primarily the legs and glutes but also injection side and a little on the shoulder/back of the same side of the injection site and small rash on each ear. This continued for three days intermittently. The rashes stayed for about 1-2 hours then new ones would appear as the old ones faded. Friday, I was finally itch-free by later in the evening. I did not take any medication or apply any more anti itch cream despite the intense itching sensation. I took pictures for documentation if you need them.
54 2021-05-27 lymph node swelling Swollen glands in the right arm.
54 2021-05-27 swelling face PATIENT WAS FINE IMMEDIATELY AFTER. ABOUT 13 MINUTES LATER, SHE CAME TO RPH ASKING IF GOOSE BUMPS A... Read more
PATIENT WAS FINE IMMEDIATELY AFTER. ABOUT 13 MINUTES LATER, SHE CAME TO RPH ASKING IF GOOSE BUMPS ARE NORMAL. SHE SAID HER SKIN WAS MORE PINK THAN NORMAL, WHICH RPH COULD NOT SEE. SHE STARTED HAVING TINGLING DOWN THE ARMS AND LEGS AT APPROX 15 MINUTES. HEADACHE STARTED SHORTLY AFTER. NO ITCHINESS, INCREASED HEARTRATE OR RESPIRATORY DISTRESS. 17 MINUTES, PATIENT STATES HER FACE FEELS LIKE A TIGHT MASK. 911 CALLED. PATIENT IS COMPLETELY RESPONSIVE AND CALM, BUT CONCERNED. 32 MINUTES, MEDICS ARRIVE AND TAKE VITALS. BP IS ELEVATED, PULSE OX NORMAL, LUNGS ARE NORMAL. MEDICS STATE THERE IS NOTHING LIFE THREATENING AND PATIENT MAY GO TO THE HOSPITAL IN AMBULANCE OR WITH HER CHILDREN IF SHE WANTS TO. PATIENT WALKS TO FRONT OF STORE SAYING HER FACE WAS SWELLING.
54 2021-05-28 swollen extremities Next day felt like flu symptoms hot/cold took Tylenol went to bed, next day felt better but now arm ... Read more
Next day felt like flu symptoms hot/cold took Tylenol went to bed, next day felt better but now arm red, sore, hot to touch and swollen/ lump at injection site. Also lump under armpit/sore, applied ice & took ibuprofen, next day arm still ref/hot/lump, armpit still sore, but less of a lump.
54 2021-05-30 lymph node swelling, lymph node pain Afternoon of the day after I got my 2nd dose, I started feeling ?ugh?. Tired, feverish (no fever a... Read more
Afternoon of the day after I got my 2nd dose, I started feeling ?ugh?. Tired, feverish (no fever at first), headache. By next day, I was feeling body aches and felt more ?ugh?. Low grade fever around 99...got up to 100 once. I noticed swollen lymph nodes in my left armpit and tenderness. Probably was sore for 6 days, then went away. As far as the other symptoms, they were gone by the 4th day after I got my vaccine (2nd dose).
54 2021-05-31 peripheral swelling - Teeth nerve pain - Extreem thirst - Swelling and warm hands and feet and aching - Ear pain and ti... Read more
- Teeth nerve pain - Extreem thirst - Swelling and warm hands and feet and aching - Ear pain and tinnitus and muffled sound (hearing loss) - Neck pain - Lower Back pain (4/19) - Middle back pain - Hiccups - Dry leathery skin (skin around fingernails and toenails peeled, hang nails (toes and fingers), lips cracked peeled overall skin looked dry wrinkled) no amount of oil or lotion helped. - Mouth painful blisters in the back that never popped just went away - Narcolepsy like tired episodes 35 minutes after vaccine 2x since - Dizzy when standing (evening of vaccine) - Knee patella dislocated and both knees seem unstable like they are going to dislocate entirely when leg is twisted like turning. - Tender to the touch and pain under left rib cage 4/13/21 one episode of narcolepsy weird tire episode that lasted a total of maybe 10 minutes with complete waking up just as I laid down to nap. Right arm hurt but not bad. Chills with a temperature of 97.1F and later was drenched in sweat with a temperature of 97.8F. Woke up super thirsty and was so thirsty for several days drinking 1.5 gallons of water and still being thirsty even when I tried some salt pills. 4/16/21 Really red, swollen and itchy eyes (allergies) with sinus headache 4/17/21 lower back went out slowly all day till I was stuck in bed with ice. Right arm tingling like pins and needles. Lips super dry cracking and peeling. 5/14/21 started prednisone
54 2021-06-03 peripheral swelling Arm tingle a few minutes after 2nd vaccine; Next day sore arm; 100.8 fever/ Fever lasted 12 hours; T... Read more
Arm tingle a few minutes after 2nd vaccine; Next day sore arm; 100.8 fever/ Fever lasted 12 hours; Then itchy and swollen arm end of day 3; Then itchy and swollen arm end of day 3; This is a spontaneous report from a non-contactable consumer (patient). A 54-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided), via an unspecified route of administration in left arm on 03Mar2021 at 15:30 (at the age of 54-years-old) as a single dose for covid-19 immunisation. Patient had known allergy to neomycin. Medical history included chronic venous insufficiency (CVI) and lymphedema. Concomitant medication included apixaban (ELIQUIS) and acetylsalicylic acid (ASPIRIN). Patient did not receive other vaccine in four weeks of vaccination. Other medication in two weeks included apixaban (ELIQUIS) and acetylsalicylic acid (ASPIRIN). Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. Patient had previously received first dose of vaccine in left arm on 09Feb2021. On 04Mar2021 at 12:00, arm tingle a few minutes after 2nd vaccine. Next day sore arm and 100.8 fever lasted 12 hours. Then itchy and swollen arm end of day 3. Need a Benadryl. No treatment was received. The outcome of all events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
54 2021-06-03 peripheral swelling She had sever swelling on her left arm the size of a baseball, bruised, numb and painful. Treated it... Read more
She had sever swelling on her left arm the size of a baseball, bruised, numb and painful. Treated it with ice, no pressure on arm. Took two days to go down.
54 2021-06-03 swelling face Initial Evaluation: Throat tightening for few seconds only. Swelling on face near eye, tingling on l... Read more
Initial Evaluation: Throat tightening for few seconds only. Swelling on face near eye, tingling on lips Patient is alert and responsive. Refused to call 911, she stated she felt better. BP 149-91 Pulse: 82 02 96%. Given oral benadryl capsule 25 mg. Patient feels better, throat tightening resolved, little swelling on right side of face on right eyelid. Alert and oriented x4, no shortness of breath, no chest pain. Patient advised to go to the ER for further evaluation. Patient agrees to go to the ER but refused to go via nonemergent ambulance or 911. Patient prefers to go by herself to the ER. Refused to call ambulance.
54 2021-06-04 swelling face, swelling, lymph node swelling Left side neck & jaw lymphadenopathy and swelling; Left side neck & jaw lymphadenopathy and swelling... Read more
Left side neck & jaw lymphadenopathy and swelling; Left side neck & jaw lymphadenopathy and swelling; Left side neck & jaw lymphadenopathy and swelling; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number not reported, patient was not pregnant and 54-years-old at the time of vaccination), via an unspecified route of administration in Arm Left on 01Mar2021 at 15:00 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced left side neck & jaw lymphadenopathy and swelling. reported that patient not received other vaccine in four weeks, reported that left arm injection site is normal, no treatment received for AE. Patient had not COVID prior vaccination and not tested COVID post vaccination. Reported that NKDA (No Known Drug Allergy). The outcome of reported events was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
54 2021-06-06 peripheral swelling Ten days after my second COVID vaccine, I woke up one morning and could barely walk. My feet were v... Read more
Ten days after my second COVID vaccine, I woke up one morning and could barely walk. My feet were very painful. My calves, ankles, forearms, wrists and base of my skull were experiencing "charlie horse" like sensations. Prior to this occurrence, nine days after my first COVID vaccine, I experienced what appeared to be an infection in my right index finger, no explanation how it happened. There was no incident leading up to it. My finger bled on the top side for no known reason and then a discolored painful bump appeared near the fingertip (on the palm side of my hand). I could not bend my finger. It was extremely swollen and painful. I visited the doctor about this on 1/15/21 and was prescribed a 10 day anti-biotic. I completed the regimen. The swelling and pain went away. The discolored raised bump did not. The spot which bled healed with no problem. This report is difficult to navigate. To make sure the dates of my COVID vaccines are clear and the onsets of my symptoms--- 1st Pfizer shot was given on Tuesday, January 5, 2021 in my right arm. The onset of first symptoms occurred on Thursday afternoon, January 14. I visited the doctor for this the following day (January 15). 2nd Pfizer shot was given on Tuesday, January 26, 2021 in my left arm. The onset of symptoms as described below began early morning 10 days after the second shot was administered. I woke up with these symptoms (as described below).
54 2021-06-07 herpes virus infection Aprox. two hours after vaccine I had one small blister show up on the palm of my left hand. Later t... Read more
Aprox. two hours after vaccine I had one small blister show up on the palm of my left hand. Later that day it was three blisters and over the next several days turned into a cluster of blisters. After conversations with PCP and vaccine administration site, I got an appointment with new PCP on May 7, 2021 where he said the blisters were consistent with herpetic vesicles and I was treated with acyclovir which dried up the blisters. On May 18, 2021 I had my second Covid vaccine at the same facility as the first vaccine. (Pfizer ER8727). The blisters returned the next day (May 19, 2021). I contacted Dr via email message and he gave me another 7 day round of acyclovir. The blisters dried up almost completely. On aprox. June 3, 2021 I had 3 or 4 blisters and by June 4, 2021 I had multiple blisters covering an area. Went back to Dr on June 7, 2021 where he referred me to a Dermatologist. That appointment is scheduled for June 23, 2021
54 2021-06-07 peripheral swelling Patient came in for her second dose of the Covid-19 immunization. She stated that the arm had hurt s... Read more
Patient came in for her second dose of the Covid-19 immunization. She stated that the arm had hurt since her last shot, was swollen and she thought had a foreign body left inside the arm. She believed the needle had broken off in the arm. I reviewed her paperwork from the previous shot and no notes were made regarding the integrity of the vaccine administration. I examined her arm by touching and feeling the area of the vaccine but could not feel anything inside the arm. She was referred to the ER for evaluation, In the ER they performed an Xray but did not find anything inside the arm. She was diagnosed with cellulitis and was prescribed antibiotics.
54 2021-06-08 lymph node swelling Body aches; Sore throat; Fever; Headache; Nausea; Cough; chills; Swollen lymph nodes; Feeling tired;... Read more
Body aches; Sore throat; Fever; Headache; Nausea; Cough; chills; Swollen lymph nodes; Feeling tired; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via unspecified route of administration in left arm on 10Mar2021 at 15:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Medical history included gastroparesis. The patient was allergic to penicillin, Bactrim and Cipro. Concomitant medications included Estradial (MANUFACTURE UNKNOWN), Topamax (MANUFACTURE UNKNOWN), Imitrex ( MANUFACTURE UNKNOWN) and Wellbutrin (MANUFACTURE UNKNOWN), from an unknown date. On 12Mar2021 at 18:45 patient experienced body aches, sore throat, fever, headache, nausea, cough, chills, swollen lymph nodes and feeling tired. The patient did not receive treatment for the reported events. The clinical outcome of the body aches, sore throat, fever, headache, nausea, cough, chills, swollen lymph nodes and feeling tired was recovering. No follow-up attempts are needed. No further information is expected.
54 2021-06-09 lymph node swelling, lymph node pain minor swelling & tenderness of left axillary lymph node; minor swelling & tenderness of left axillar... Read more
minor swelling & tenderness of left axillary lymph node; minor swelling & tenderness of left axillary lymph node; This is a spontaneous report from a contactable consumer (Patient). A 54-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3248, Expiration Date: not reported) via an unspecified route of administration in left arm on 21Apr2021 11:00 as 2nd dose, single dose for COVID-19 immunization. The patient previously took first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EL3248, Expiration Date: not reported), via an unspecified route of administration, in left arm on 31Mar021 10:00AM at single dose for COVID-19 immunization. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Medical history included hypothyroidism, hypertension, osteoarthritis and asthma. Patient had known allergies to shellfish, bee venom, seasonal allergies, dust & mold.Concomitant medication(s) included within 2 weeks of vaccination, levothyroxine sodium (SYNTHROID); liothyronine sodium (CYTOMEL); lisinopril; budesonide, formoterol fumarate (SYMBICORT); diphenhydramine hydrochloride (BENADRYL). On 22Apr2021 19:00,The patient experienced minor swelling & tenderness of left axillary lymph node. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the adverse event. The outcome of the events was resolved on 28Apr21 at 05:00. No follow-up attempts are needed. No further information is expected.
54 2021-06-09 swelling Swelling pain Redness and sensation
54 2021-06-10 peripheral swelling, swelling swollen arm; 2 days later hives under chin on left side/ hives on left cheek/ hives on her left trun... Read more
swollen arm; 2 days later hives under chin on left side/ hives on left cheek/ hives on her left trunk, face, and arm; throat started to close; mouth started to itch; swollen itchy eyes; swollen itchy eyes; sneezing; swollen lump in shoulder immediately; This is a spontaneous report from a contactable consumer (the patient). A 54-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EW0167), via an unspecified route of administration in the left arm on 21May2021 17:00 (at the age of 54-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma, allergies, leaky heart valve, fusion feet, cholesterol, triglycerides, ulcers, and allergy to sulfa and bananas. The patient had a negative COVID-19 nasal swab in Jan2021, and twice in Apr2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: montelukast sodium (SINGULAIR), fexofenadine hydrochloride/ pseudoephedrine hydrochloride (ALLEGRA D), diphenhydramine hydrochloride (BENADRYL), citalopram hydrobromide (CELEXA), eicosapentaenoic acid ethyl ester (VASCEPA), budesonide/ formoterol fumarate (SYMBICORT), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 19:00, within 2 hours of vaccination, the patient experienced swollen itchy eyes, mouth started to itch, sneezing, throat started to close; swollen lump in shoulder immediately. Two days later (23May2021), hives under chin on left side. The next day (unspecified date) she got hives on left cheek, then a few days later (unspecified date), hives on her left trunk. It was also reported she had hives on left side of trunk, face, and arm, and had a swollen arm. For treatment, the patient took 3 BENADRYL and 20 mg of prednisone. The outcome of the events was recovering. Since the vaccination, the patient has been tested for COVID-19 on an unspecified date (unknown results).
54 2021-06-17 peripheral swelling Swelling in legs, ankles & feet.
54 2021-06-20 oral herpes Vaccine dose 1 on 4/6/21, 2 on 4/27/21. 1-Symptoms of Graves disease possibly experienced around end... Read more
Vaccine dose 1 on 4/6/21, 2 on 4/27/21. 1-Symptoms of Graves disease possibly experienced around end of April/begin May 2021-Graves disease flare detected by elevated T3, T4 and suppressed TSH levels on 5/17/21, in treatment with methimazole. 2-Herpes simplex/cold sore on the lip, treated with valacyclovir, resolved. 3-Tinnitus experienced around 4/20/21, not resolved.
54 2021-06-21 guillain-barre syndrome 6/8 Patient presented in the Ed with weakness, tingling and numbness in the hands and lower extremit... Read more
6/8 Patient presented in the Ed with weakness, tingling and numbness in the hands and lower extremity. She reports symptoms for the previous 3 days. LP remarkable for elevated proteins (80) with 0 WBC and RBC. Recent questionable URI and a few episodes of diarrhea were reported. Pt had "stocking-glove paresthesias suggestive of Guillain-Barre Syndrome and was placed on IVIG therapy. Discharged from the hospital improved on 6/19/2021.
54 2021-06-22 swelling, lymph node swelling When the shot was given it hurt like any normal Vaccine or shot that I have been given before. But,... Read more
When the shot was given it hurt like any normal Vaccine or shot that I have been given before. But, the next day I woke up and my armpit was swollen and the underneath part of my arm was very tender to the touch. These symptoms lasted a little over a week total. I went back to the clinic on 5/25/21 just due to how long it was staying swollen and tender wanted to make sure that this was something that needed to be documented. Doctor advised me to not take the second dose due to my reaction to the first dose. I had Covid 19 back in October of 2020.
54 2021-06-23 swelling After the first shot iexperience slight dizziness, was told to sit for 15 minutes, which I did. On... Read more
After the first shot iexperience slight dizziness, was told to sit for 15 minutes, which I did. Once the time lapsed I was told to report my info to the CDC and they would monitor it, which I did. After the second shot given on February 19, 2021, about a week later it's when I experience this sore pain in my neck, which felt like a lump, so I called my Dr to get in to see him asap, he requested the ultrasound then the CT scan.
54 2021-06-24 peripheral swelling rash all over the body/ rash on torso; Temperature 103.9/Fever up to 103; felt like her body was bei... Read more
rash all over the body/ rash on torso; Temperature 103.9/Fever up to 103; felt like her body was being attacked inside, stinging all over inside and settled in the joints/pain; felt like an army of ants were crawling and attacking inside; Pain all over but especially in joints; Arm swelled; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 04Mar2021 at 05:30 AM (Batch/Lot number and expiry date were not reported) (at the age of 54-years-old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included brain trauma that has resulted in some chronic health issues. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medications were not reported. On 04Mar2021, the patient received the first dose and she had an immediate reaction which lasted almost 14 days. She called the County health department and they told her that it was normal to have that reaction that severe for some people and that she can receive her second vaccine and she spoke with her doctor who said that she will not go forward until they figure out what happened. She was told by the County to take Tylenol and go to bed for a while. The patient had a rash all over the body and had a temperature of 103.9. She felt like her body was being attacked inside, stinging all over inside and settled in the joints. She felt better for approximately two weeks, 14 days not great but better. She felt little better and on 24Apr2021, she experienced the exact same reaction that is 10 times worse and it settled in her joints, which has been awful and it was not going away and she changed 4 doctors now and they all said there was nothing that they can do when you have a reaction to the vaccine. Patient was asking if there is something that she can do so that maybe she can get her life and body back and she was very sick and doesn't know what to do. Upon follow up on 09Jun2021, seriousness criteria was reported as disabling /incapacitating. On 04Mar2021 at 05:45, the patient experienced an immediate reaction: the patient's arm swelled, felt like an army of ants were crawling and attacking inside, had fever up to 103 and did not break with Tylenol (directed to take and told this all was normal). The patient also had rash on torso, pain all over but especially in joints. Patient gradually felt better after fourteen days. Then on 04Apr2021 (as reported), she had the very same reaction but so much worse and it has never left, except for no rash. The fever lasted 14 days but is gone. She saw the doctor to assure it wasn't something other than the shot and assured he could not see that it was anything else and it would take a while to dissipate. Patient saw a functional medicine doctor to treat naturally, to no avail. She saw her primary physician who also has no idea how to treat. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the events joint pain, stinging, arm swelled and rash all over the body was not recovered, while for fever was recovered on 18Mar2021. Information on the batch/lot number has been requested.
54 2021-06-26 lymph node swelling, lymph node pain Extreme lethargy, body felt hot no fever, chills, joints pain, dizziness, large swelling of the left... Read more
Extreme lethargy, body felt hot no fever, chills, joints pain, dizziness, large swelling of the left side lymph nodes from armpit to breast hard and painful at touch.
54 2021-06-26 swelling, peripheral swelling Patient had vaccine administered in her left upper arm at 1100am and by that evening she had signifi... Read more
Patient had vaccine administered in her left upper arm at 1100am and by that evening she had significant swelling to her right upper thigh/groin area. On 06/25 the area of swelling measured 9 inches long by 5 inches wide. No erythema, warmth, tenderness, or fever.
54 2021-06-27 lymph node pain, lymph node swelling Axillary lymph nodes are swollen and tender. No fever, chills.
54 2021-06-28 axillary mass woke up with pain under left arm and felt a lump by left breast, mammogram and ultrasound was done a... Read more
woke up with pain under left arm and felt a lump by left breast, mammogram and ultrasound was done and the doctor does not know what it is. there is now an biopsy scheduled because the doctor does not know what the lump is.
54 2021-06-29 peripheral swelling Pain in both lower extremity; Swelling in both lower extremity; Red spots; Hives; This is a spontane... Read more
Pain in both lower extremity; Swelling in both lower extremity; Red spots; Hives; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6205) via an unspecified route of administration in left arm on 18Mar20219 (at the age of 54 years old) at 14: 00, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 15:00, the patient experienced pain and swelling in both lower extremity, red spots and hives. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of pain and swelling in both lower extremity, red spots and hives was not recovered at the time of reporting. It was reported unknown whether the patient received any therapeutic measures. No follow-up attempts are needed. No further information is expected.
54 2021-06-30 lymph node pain, lymph node swelling Fist even was a mild reaction of soreness at sight, odd metallic taste for about a week. Second dose... Read more
Fist even was a mild reaction of soreness at sight, odd metallic taste for about a week. Second dose I began with with pain and swelling in my lymph glands under the arm where injection was given. I went to the clinic after several days of this worsening. Instructions per dr were to let it ride for another couple of days so my natural immunity could do it's job. But, if worsened to return. They called with follow-up. Swelling had subsided, and pain lessened. But, it spread to other lymph on the left side. Additionally, I had an odd taste again. The immune system was working but pain only lessened about early June. On June 16, 2021, I awoke with a pain in my center chest, like a pulled muscle. It has since spread across my diaphragm area under the breasts. This may or may not be related. It is still uncomfortable but not as severe today, at 2 weeks+. I had my least clear mammogram on March 4,2021 (3D) prior to March 9, 2021 first COVID19 injection.
54 2021-06-30 swelling Covid-19 diagnosis; Covid-19 diagnosis; still feeling weak; short of breath; swelling; pain in her a... Read more
Covid-19 diagnosis; Covid-19 diagnosis; still feeling weak; short of breath; swelling; pain in her arms and in her back; pain in her arms and in her back; dark black spots on her stomach and legs where the knots were; knots in her stomach; rash in her stomach; This is a spontaneous report received from a contactable female consumer. A 54-year-old female patient received second dose of bnt162b2 (Formulation: Solution for injection PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 22Apr2021 14:30 (at the age of 54-years-old) as dose 2, single and received first dose via an unspecified route of administration, administered in Arm Left on 01Apr2021 14:30 (Batch/Lot Number: EN6201) as dose 1, single for covid-19 immunisation. Medical history included ongoing blood pressure high (Has had for over 30 years), diabetes mellitus from 2020 and ongoing and covid-19 from 24Feb2021 to an unknown date. The concomitant medications were not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date the patient experienced covid-19 diagnosis, covid-19 diagnosis, still feeling weak, short of breath, swelling, pain in her arms and in her back, pain in her arms and in her back and dark black spots on her stomach and legs where the knots were. On 26 Apr2021 the patient experienced knots in her stomach and rash in her stomach. It was reported that she is still feeling weak and short of breath as a result of Covid-19 diagnosis?. It was reported that she is still having symptoms of Covid that she had on 24Feb2021. After getting the Covid 19 vaccine, she had knots in her stomach and a rash. Her doctor gave her pain medicine and some cream to resolve it. The patient reported that she went to see the doctor and he said that it didnt look it came from the shots; he thought it was a riser. She reported that knots went down by themselves, she didn't even get the cream he prescribed for her. But she still has dark black spots on her stomach and legs where the knots were. The first spot she noticed was under her bra after she got the 1st dose of the Covid 19 vaccine, and the knot was real hard. She thought it was just a side effect from the 1st shot. She did not tell the doctor about that and was just monitoring it. When she got the 2nd dose, another spot popped up, and that's when she called him and let the doctor know. She reported that the swelling and the knots have gone down; she just has the dark black spots where the knots were that are left. She never got the cream because she couldn't afford the cream that the doctor prescribed. She had pain in her arms and in her back and was given muscle relaxer for that and Tylenol. The name of the cream the doctor prescribed was Mupirocin cream, but she never used it. Therapeutic measures were taken as a result of pain in her arms and in her back. The patient visited physicians office on 26Apr2021 and not emergency room. The patient had no relevant test, no family medical history. The patient had no prior vaccinations. The patient was not vaccinated with any other vaccine on the same day. The outcome of the event knot in her stomach and rash in her stomach were resolving, for rest of the events the outcome was unknown. Follow up needed, further information has been requested.
54 2021-07-02 peripheral swelling Left ear and left side of face from my eye toward ear went numb/Numbness; Left ear and left side of ... Read more
Left ear and left side of face from my eye toward ear went numb/Numbness; Left ear and left side of face from my eye toward ear went numb/Numbness; hands swelled/Hands are still showing swelling on day 7; terribly sore arm; light headed; chills(but no fever); This is a spontaneous report from a contactable consumer or other non health care professional(Patient herself) of 54-year-old (non-pregnant) female patient received the first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Left arm on 09Apr2021 08:15 (at the age of 54-years-old) at a single dose for covid-19 immunisation at Pharmacy or Drug Store. Medical history included none and Concomitant medications were not reported. No Known allergies reported. No Allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, patient had not been tested for COVID-19. On 09Apr2021, the patient experienced Left ear and left side of face from my eye toward ear went numb, hands swelled, had to take jewelry off. Numbness went away by next morning. Hands were still showed swelling on day 7, still not able to put jewelry on. She had some Normal side effects earlier in the day, terribly sore arm, light headed, chills (but no fever). No treatment was received for the events caused. The outcome of events was recovering. Information on the lot/batch number has been requested.
54 2021-07-03 lymph node swelling After second dose- I experienced worsening Inflammation and intense pain within 2 days of getting VX... Read more
After second dose- I experienced worsening Inflammation and intense pain within 2 days of getting VX. This lead to inability to move head/neck side to side or lift arm. tingling sensation traveling down arm and into fingertips. Numbness of fingertip "pad". Muscle knots/maybe lymph node knots peaked at 6 weeks and slowly decreased by week 12. Numbness and tingling started around week 4 peaked at week 7 and slowly slowly went away by week 12.
54 2021-07-04 c-reactive protein increased Developed Acute Pericarditis.
54 2021-07-08 lymph node swelling This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnan... Read more
This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the right arm on 19Mar2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic lung disease and diabetes. The patient had a history of allergy to SEPTRA and CARDIOLITE. The concomitant medications included metformin (MANUFACTURER UNKNOWN), empagliflozin (JARDIANCE), losartan (MANUFACTURER UNKNOWN), acetylsalicylic acid (BABY ASPIRIN) and HCTC for unknown indication received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the right arm on 23Feb2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 23Mar2021, the patient experienced hard tender lump at injection site with size of a quarter which was still there after one week. swollen, hard, painful lymph node on the right ear, quite large, about 2 1/2 inches long. No therapeutic measures were taken for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the vaccination site lump and painful lymphadenopathy was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
54 2021-07-08 swelling 103.4 fever, severe body aches, headache,chills, muscle pain, extreme fatigue and tiredness, nausea,... Read more
103.4 fever, severe body aches, headache,chills, muscle pain, extreme fatigue and tiredness, nausea, diarrhea, feeling unwell, muscle weakness, arm pain with swelling and itching and now possible shortness of breath
54 2021-07-09 white blood cell count increased, c-reactive protein increased, peripheral swelling 10 days after the second injection, I went to the hospital because I had abdominal pain and had been... Read more
10 days after the second injection, I went to the hospital because I had abdominal pain and had been throwing up. They found blood in my urine, but no other reason for the right flank pain or abdominal pain. At one point my arms were swollen and would wake me up with intense pain - tingling and numb Lyme Disease - Doxy for a 4 weeks - no help, not retested for it 2 UTIs - Ciprofloxacin (500 mg - 10 days) and another antibiotic before that
54 2021-07-11 anaphylactic reaction I've been having seizures and dyskinesia which is MS related. I've also had weakness and leg paralys... Read more
I've been having seizures and dyskinesia which is MS related. I've also had weakness and leg paralysis so that I have to use walker when I'm out and about and that's all come out since leaving hospital. I've been dealing with terrible fatigue, being winded, having no strength, weakness since leaving hospital on April 20 and it keeps getting worse. I'm seeing my PCP tomorrow 07/13/2021. A week ago I was seeing a hematologist that I got in touch with and she was trying to give me iron to help with anemia even though numbers aren't bad, but I'm so symptomatic since vaccine, but I'm allergic to iron. She tried something else on June 28 and I had an anaphylactic reaction and that was to deal with fatigue and symptoms of anemia. The seizures and Dyskinesia prompted my MS doctor to want me to get a new set of MRIs but because my crohn's is so bad I don't have time to do any of this. Today I was scheduled for July 29 to see where blood clots were formed in my legs from the vaccine. I've been experiencing intestinal hemorrhaging since being on blood thinners, it oozes out of my stoma because I have an ileostomy and that's a new symptom as well. That's probably why my anemia is so bad because I'm having the intestinal hemorrhaging. July 28 I have intestinal scoping.
54 2021-07-11 swelling face After 4 hours of 1st injection started to feel heat and swelling of face. In the morning woke up t... Read more
After 4 hours of 1st injection started to feel heat and swelling of face. In the morning woke up to red swollen cheeks and eyes. Itching sporadic over entire body. Eczema that was dormant flared on legs and upper arms. Severe headache which did not respond to Tylenol.
54 2021-07-12 lymph node pain, lymph node swelling Minimal pain innodes under right arm; Pain in neck.; Very painful, swollen lymph nodes under the lef... Read more
Minimal pain innodes under right arm; Pain in neck.; Very painful, swollen lymph nodes under the left arm.; Pain in left.; Pain in shoulder.; headache; fever; body aches; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 11:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos thyroiditis. Concomitant medications included T3 and T4 thyro meds (medicines). The patient had known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. On 26Mar2021 at 21:00, the patient experienced very painful, swollen lymph nodes under the left arm. There was minimal pain in the nodes under the right arm. The patient also had pain in the left arm, neck and shoulder. Then the patient experienced headache, fever and body aches for two days following injection. It was reported that lymph nodes under the left arm were still swollen. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included the treatment with ibuprofen. The clinical outcome of headache, fever and body aches was recovered on 28Mar2021; while the outcome for painful swollen lymph nodes under the left arm, painful nodes under right arm, pain in left arm, neck, and shoulder were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
54 2021-07-12 peripheral swelling Patient was administed the Pfizer Covid vaccination. She was waiting in the waiting room for 15 minu... Read more
Patient was administed the Pfizer Covid vaccination. She was waiting in the waiting room for 15 minutes. After 7 to 10 minutes she notified staff that her arm was swelling and she did not feel right. Pharmacist went to talk with patient. Her arm was swelling and her head did not feel right. She reported she was dizzy and felt faint. 911 was called immediately. Theyresponded and after examination patient was transported to hospital.
54 2021-07-13 lymph node swelling Pain in arm, joint pain, swollen gland in armpit (very painful and large), sensitive skin, fatigue
54 2021-07-13 lymph node swelling After my first vaccine on 12/17/2020 I had swollen clavicle glands on the left side (same side as my... Read more
After my first vaccine on 12/17/2020 I had swollen clavicle glands on the left side (same side as my vaccine) and never seen a physician concerning the swelling After my second vaccine on 01/09/2021 received vaccine in opposite arm (Right Arm) and again my clavicle gland swelled on the side that I received the vaccine On 07/03/2021 I became sick with what I thought was a head cold on 07/06/2021 I tested positive for COVID-19
54 2021-07-15 swelling Reoccurrence of previously resolved allergic angioedema and rash.
54 2021-07-15 swelling face My face was swollen especially around my eyes.
54 2021-07-17 lymph node swelling painful, burning lump left breast; Swollen lymph nodes; painful, burning lump left breast/ lot of pa... Read more
painful, burning lump left breast; Swollen lymph nodes; painful, burning lump left breast/ lot of pain with this lump and some slight burning; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN5318, patient was 54-year-old at the time of vaccination), via an unspecified route of administration in Arm Left on 21Apr2021 at 10:00 as single dose for covid-19 immunisation, as she works in a lab and comes into contact with a lot of things and deals with blood. Medical history included, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. No illness/AE and family Medical History Relevant to AE(s) reported. There were no concomitant medications. Patient did not receive prior Vaccinations within 4 weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: GR8733, patient was 54-year-old at the time of vaccination), via an unspecified route of administration in Arm Left on 31Mar2021 as single dose for covid-19 immunisation. It was reported that patient had done some research that showed it could be a side effect and was wondering if it had been reported. She reports that she had seen her HCP and went yesterday for mammogram, and now they want to biopsy the lump. She was asking if it had been reported as she was trying to weigh it out and see what this was. Reported that patient want to know how Long Side Effects Last, specifically Swollen lymph nodes are likely to had resulted from a robust vaccine-elicited immune response. Referred to HCP for guidance on her symptoms. Emailed attached CONS-what are the risks of the vaccine. Reported that she went to the doctor and found out she had a lump in her left breast. When she got there, they asked her if she had taken the shot, and she said yes. She looked up the side effects and that was one of the side effects, a lump in the breast after taking the shot. The lump is the same size. She was having a lot of pain with this lump and some slight burning. She went to the doctor yesterday, and they did a mammogram and an ultrasound. They couldn't tell exactly what it was, and she had to go and do a biopsy. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient experienced painful, burning lump left breast, lot of pain with this lump and some slight burning, swollen lymph nodes on an unspecified date in 2021 and the patient experienced painful, burning lump left breast on 04Jun2021. It was reported that time of Onset (24-hour clock) was about 07:30-08:00. Reporter seriousness for Lump in left breast was unspecified. Patient visited Physician Office for AE(s). No hospitalization was reported. The patient underwent lab tests which included mammogram and ultrasound breast resulted as unknown result, they couldn't tell exactly what it is, Date: 28Jun2021 (Not confirmed). The outcome of event painful, burning lump left breast was not recovered and outcomes of events painful, burning lump left breast/ lot of pain with this lump and some slight burning, swollen lymph nodes was unknown.
54 2021-07-19 peripheral swelling Strange pains in unusual places, not just injection site. Headache started on left side of neck head... Read more
Strange pains in unusual places, not just injection site. Headache started on left side of neck heading to bad headache. Headache ceased upon sleeping, but was still present when awakened by nature around 2am. Woke up around 6am and still have headache. Just noticed my feet swelling, left is moreso than right. Slight dizziness (even while sitting). This morning, throat feels tight, as if being choked.
54 2021-07-19 swelling * Headache as well as pain in the neck, shoulders, and back * Racing heartbeat and heart palpitation... Read more
* Headache as well as pain in the neck, shoulders, and back * Racing heartbeat and heart palpitations * Ongoing pain, swelling, stiffness in the hands and fingers, elbows, knees, ankles, and feet * Ongoing tiredness and fatigue
54 2021-07-27 lymph node pain, lymph node swelling Severe swollen glands. Started in lymph node near collarbone on the side where I got the injection.;... Read more
Severe swollen glands. Started in lymph node near collarbone on the side where I got the injection.; Lymph nodes in neck were painful; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 30Mar2021 at 10:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and asthma. The patient did not have any allergies to food, medications, or other products. Concomitant medications included metformin (MANUFACTURER UNKNOWN), dulaglutide (TRULICITY) and dapagliflozin propanediol monohydrate (FARXIGA) all from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Eng204) via an unspecified route of administration in the right arm on 07Mar2021 at 15:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 16:00, 3 days after the vaccination, the patient experienced severe swollen glands started in the lymph node near the collarbone on the side where she got the injection and lymph nodes in the neck were painful in the next days. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the event severe swollen glands started in the lymph node near the collarbone and lymph nodes in the neck painful were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
54 2021-07-27 neck mass, lymph node pain, peripheral swelling, lymph node swelling A week or so after first dose, observed a lot of muscle pain in my shoulders, upper back, neck, and ... Read more
A week or so after first dose, observed a lot of muscle pain in my shoulders, upper back, neck, and head I attributed it to stress and hard work. I used muscle creams and percussion massager to try to alleviate the pain. I was also fatigued. It wasn't until July 8th that I noticed that the lymph node on the left side of my neck near my collar bone was very swollen (once I pointed it out, people could see it). That was the cause of my pain. My husband and I took a very short hike, less that half mile, but included many stairs and some uphill and downhill traversing. On Saturday July 10th, I was extremely fatigued, and my lower left hip ached. I used muscle creams to try to alleviate that pain. On Thursday July 15th,
54 2021-07-28 lymph node swelling Swollen lymph node on left side between shoulder and neck; This is a spontaneous report from a conta... Read more
Swollen lymph node on left side between shoulder and neck; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8734) via an unspecified route of administration in the left arm on 30Mar2021 at 07:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient did not receive any medication within two weeks of vaccination. The patient did not have any allergies to medication, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 03Mar2021 at 07:00(at the age of 54-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 12:00, the patient experienced swollen lymph node on left side between shoulder and neck. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event swollen lymph node on left side between shoulder and neck was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
54 2021-07-28 lymph node swelling Swollen left shoulder lymph node. Size of a plum. Dr. told me that this was a known reaction to covi... Read more
Swollen left shoulder lymph node. Size of a plum. Dr. told me that this was a known reaction to covid vaccine and to do nothing. Swelling has decreased. Now size of a marble.
54 2021-07-28 swelling face I was having severe jaw pain on the right side of my face. I started having a tingling feeling in my... Read more
I was having severe jaw pain on the right side of my face. I started having a tingling feeling in my fingers and my toes. I started having memory loss, confusion, migraines and swelling on the right side my face and my eyes was swollen shut. I am also having ringing in the right ear.
54 2021-07-29 axillary mass egg-sized lump in left armpit; I got a rash on chest, face, neck, and behind the ears; I got a rash ... Read more
egg-sized lump in left armpit; I got a rash on chest, face, neck, and behind the ears; I got a rash on chest, face, neck, and behind the ears; I got a rash on chest, face, neck, and behind the ears; I got a rash on chest, face, neck, and behind the ears; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 18:00 as dose 2, single for covid-19 immunisation Medical history included blood cholesterol increased, hypertension, depression. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was Reported that, egg-sized lump in left armpit and about 40 hours after injection, got a rash on chest, face, neck, and behind the ears on 07Mar2021 14:30 with outcome of recovering No follow up attempts are possible. No further information is expected.
54 2021-07-29 lymph node swelling Body aches through neck, shoulders, back; Body aches through neck, shoulders, back; Body aches throu... Read more
Body aches through neck, shoulders, back; Body aches through neck, shoulders, back; Body aches through neck, shoulders, back; Temp of 100.4; Swollen lymph nodes in left armpit - very painful; swollen lymph nodes in left armpit - very painful; Tired - very tired; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0182) via an unspecified route of administration in the left arm on 02May2021 at 14:30 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medication. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0153) via an unspecified route of administration in the left arm on 04Apr2021 at 14:15 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03May2021 at 12:00, the patient was experienced body aches through neck, shoulders, back, temp of 100.4,swollen lymph nodes in left armpit - very painful and tired - very tired. The patient underwent lab tests and procedures which included body temperature on 03May2021 and the result was 100.4 (units unspecified). The clinical outcome of body aches through neck, shoulders, back, temp of 100.4,swollen lymph nodes in left armpit - very painful and tired - very tired were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
55 2021-01-02 swelling face, anaphylactic reaction 25 minutes after receiving the injection, there was a sudden onset of facial swelling, hives, itchin... Read more
25 minutes after receiving the injection, there was a sudden onset of facial swelling, hives, itching and airway constriction. I had already left the drive-thru vaccination clinic and was driving to the hospital emergency room where I work. I informed my colleagues of my symptoms and was treated for anaphylaxis with IV diphenhydramine and famotidine over several hours. I was given a prescription for a prednisone taper for the next 6 days.
55 2021-01-03 swelling Arm soreness Swelling Overall body feeling shaky
55 2021-01-04 anaphylactic reaction Agitation, Sedation, Anaphylaxis, Rash & HYPOtension
55 2021-01-04 lymph node swelling noted swollen lymph node left armpit area, slightly tender
55 2021-01-04 swelling face 6 days after my shot, I developed an itchy rash with moderate swelling on face mostly, neck and wris... Read more
6 days after my shot, I developed an itchy rash with moderate swelling on face mostly, neck and wrists. I am not sure of the cause - it was clearly some kind of allergy, possibly a contact allergy, but I am not sure if it is connected to the vaccine or not. I was advised to report it. It was bad enough to have been prescribed prednisone
55 2021-01-05 white blood cell count increased Severe right lower quadrant pain, anorexia over 12 hours. Went to the emergency department. Lab resu... Read more
Severe right lower quadrant pain, anorexia over 12 hours. Went to the emergency department. Lab results showed elevated WBC and CT scan showed acute appendicitis. Admitted for urgent surgery: laparoscopic appendectomy. Was hospitalized from 12/26/20-12/28/20.
55 2021-01-06 lymph node swelling, lymph node pain Swollen, sore lymph nodes
55 2021-01-06 lymph node swelling Same evening body aches and injection site was painful. In 24 hrs my lymph nodes were swollen, also ... Read more
Same evening body aches and injection site was painful. In 24 hrs my lymph nodes were swollen, also neck and arm pit. I also had headaches and body aches across my shoulder, neck and back.
55 2021-01-06 swollen extremities Patient initially experienced headache, body aches, arm pain, and swelling under the armpits. Patien... Read more
Patient initially experienced headache, body aches, arm pain, and swelling under the armpits. Patient managed symptoms with ice packs. Symptoms have resolved as of 1/6/2021
55 2021-01-07 lymph node pain, lymph node swelling 1/7/2021: 1200 PM H/A 1700 - 1100 PM Chills with continued shaking 1100 PM Febrile 102.5 1100 PM ... Read more
1/7/2021: 1200 PM H/A 1700 - 1100 PM Chills with continued shaking 1100 PM Febrile 102.5 1100 PM Swollen/Painful lymph nodes -left axilla
55 2021-01-07 lymph node swelling Dose 1 site soreness Dose 2 severe muscle and bone pain, chills, night sweats, fever, axillary lymph... Read more
Dose 1 site soreness Dose 2 severe muscle and bone pain, chills, night sweats, fever, axillary lymphadenopathy, fatigue, nausea-evaluation for symptoms- no prescribed treatment
55 2021-01-07 oral herpes At 330 am I got the chills and could not go back to sleep, after an hour went back to sleep around ... Read more
At 330 am I got the chills and could not go back to sleep, after an hour went back to sleep around 530 am started running a fever of 100.3 and had a severe headache and body aches. Fever went down with tylenol, but had headache all day. Fever did come back later in the day resolved with Tylenol. Next day fine but did have cold sores inside mouth . Head ache on 1/8 no fever or anything.
55 2021-01-07 swelling Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and ... Read more
Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and had general body aches, which has continued into 1/8/21.
55 2021-01-08 anaphylactic reaction Patient felt tongue swell, and then her throat started to close. -Anaphylaxis
55 2021-01-10 axillary mass The morning after the shot I woke up with chills, total body aches, headache and extreme fatigue. I ... Read more
The morning after the shot I woke up with chills, total body aches, headache and extreme fatigue. I broke my wrist last year and the ache in that wrist was awful. Motrin helped but this persisted throughout the day. General feeling of being unwell for the whole day and evening. The second day after the shot I woke up feeling better but in my armpit on the arm I received the shot it felt like I had a lump in my arm pit and it is sore. This is still there today, the third day after the shot.
55 2021-01-12 lymph node pain, lymph node inflammation 12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck.... Read more
12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck. 12/24/20 @ 0600 vomited x 2. Headache, runny nose, fatigue, general achiness---became worse as the day progress to include both hips and knees becoming painful. Shortness of breath with pulse ox levels of 91-97% on room air. Heart rate 104-124 bpm for 9 hours, Chest discomfort, cough, achy fingers, mild hand tremors, flushed face, nausea, decreased appetite, fatigue, chills . 12/25/20 @ 0120--severe muscle and joint pain---self medicated with 1000mg acetaminophen, stomach pain---used digestzen. tossed and turned until after 0428. 0920--increased area of painful lymph nodes: left arm axilla, breast and back of neck. Fatigue continues---although less than the day before 12/26/20 through 12/28/20 symptoms continue to decrease. 12/29/20----woke up feeling great. Took the stairs at work---no shortness of breath. At work received the mail out Covid test-----results were positive ( no symptoms of covid)
55 2021-01-12 lymph node pain, lymph node swelling On 1/7/21, seven days after receiving the first vaccine, I noticed a swollen and painful lymph node ... Read more
On 1/7/21, seven days after receiving the first vaccine, I noticed a swollen and painful lymph node in my neck on the right side. The lymph node was about the size of a large gumball. The next day I started having pain in the lymph nodes of my arm pit on the right side. The symptoms are still present six days later and I now have some swollen and tender lymph nodes in the antecubital area of the same arm. I am scheduled to get my second dose on 1/21/21. I have not had any other side affects that I know of other than feeling a little tired and mild headache on and off but that didn't seem unusual for me. The lymph node in my neck seems to be getting a little smaller as of today 1/13/21.
55 2021-01-13 peripheral swelling, lymph node swelling Egg sized lymphadenopathy under right arm 36 hours after 2D injection; flu symptoms; joint aches; mu... Read more
Egg sized lymphadenopathy under right arm 36 hours after 2D injection; flu symptoms; joint aches; muscle and joint aches; arm pain; arm pain and swelling; 1st dose of BNT162B2 on 17Dec2020 15:45/ 2nd dose on 06Jan2021 14:30; 1st dose of BNT162B2 on 17Dec2020 15:45/ 2nd dose on 06Jan2021 14:30; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 06Jan2021 14:30 at single dose for COVID-19 immunisation. Medical history included mild hypertension and arthritis. The patient was not pregnant. No Covid prior vaccination, no Covid tested post vaccination. No known allergies. Concomitant medication included estradiol, norethisterone acetate (COMBIPATCH), meloxicam, propanol. The patient previously received 1st dose of BNT162B2 in left arm on 17Dec2020 15:45 for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced egg sized lymphadenopathy under right arm 36 hours after 2D injection (08Jan2021 03:00), after flu symptoms of muscle and joint aches, arm pain and swelling at 20 hours (07Jan2021 12:00). No treatment received for the events. The outcome of events was not recovered. This case was reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of lymphadenopathy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
55 2021-01-13 peripheral swelling Burning, itching, painful rash over back, stomach and groin. Rash and swelling in hands and ankles
55 2021-01-14 lymph node pain Reaction delayed - self-care: Day 1 body aches, bad headache, Day 2 sore feet and heel especially, r... Read more
Reaction delayed - self-care: Day 1 body aches, bad headache, Day 2 sore feet and heel especially, rash on right arm. Lymph nodes sore on neck on Day 2.
55 2021-01-14 swelling Pain at shot location; swelling; chills; headache; body aches; fatigue; This is a spontaneous report... Read more
Pain at shot location; swelling; chills; headache; body aches; fatigue; This is a spontaneous report from a contactable other healthcare professional (hcp). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) first dose on 18Dec2020 13:00 (lot 121820, expiry date not reported), then second dose on 08Jan2021 15:30 (lot EK9231, expiry date not reported); both intramuscular in the left arm at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient was not pregnant at the time of the vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The vaccines were administered in a hospital. On 09Jan2021 06:30, the patient experienced pain at shot location, swelling, chills, headache, body aches and fatigue. Post vaccination, patient had COVID test nasal swab (PCR) on 05Jan2021 and the results was negative. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The patient did not receive any treatments in response to the events reported. The patient was recovering from the events pain at shot location, swelling, chills, headache, body aches and fatigue.
55 2021-01-17 swelling face, peripheral swelling 12/27/20 - Presented to urgent care with Nausea, swelling on face and hands, SOB. Was given dose of... Read more
12/27/20 - Presented to urgent care with Nausea, swelling on face and hands, SOB. Was given dose of SoluMedrol 125mg and sent to the emergency room. 12/27/20 Presents feeling sick, body aches, chills, nausea, rash and vomiting. SOB better. Given Zofran and IV fluids in ER. D/C home with prednisone and Zofran. D/C dx: Acute allergic reaction, Nausea and vomiting
55 2021-01-18 lymph node swelling 55-year-old female presented to urgent care on 1/13/2021 with headache, body aches, temp up to 100.2... Read more
55-year-old female presented to urgent care on 1/13/2021 with headache, body aches, temp up to 100.2 Fahrenheit, sore throat, and some left axillary lymph node swelling. She also had some erythema and edema to the vaccination site. She received this vaccination on January 11. Her symptoms started January 12. On January 14, 2021, patient returned to urgent care for worsening erythema and discomfort at injection site. Patient was given supportive care and discharged home.
55 2021-01-18 lymph node swelling Lymphadenopathy in right arm with intense pain, also intense pain on the back from shoulders to the ... Read more
Lymphadenopathy in right arm with intense pain, also intense pain on the back from shoulders to the waist. Arthralgia, specifically on both ankles, fever , dizziness, and nausea. treated with acetaminophen and rest.
55 2021-01-20 lymph node swelling Fatigue, nausea, headache, right axillary lymphadenopathy
55 2021-01-20 swelling face HALF HOUR AFTER SHOT IN LEFT AREM MOUTH TASTED LIKE METAL THEN ANOTHER HALF HOUR MY LEFT CHEEK, TONG... Read more
HALF HOUR AFTER SHOT IN LEFT AREM MOUTH TASTED LIKE METAL THEN ANOTHER HALF HOUR MY LEFT CHEEK, TONGUE, TEETH, JAW, NECK WENT NUMB, I CAN FEEL IT NUMB AROUND MY LEFT EYE TO. ITS LIKE BELLS PALSY WHEN I TRY TO SMILE LEFT SIDE OF LIPS GO DOWN ANSLEFT SIDE OF LIPS ARE NUMB AND THELEFT SIDE OF FACE IS SWALLEN AND JAW IS TIGHT.CHEEK FEELS THICK, TINGALING IN ARM DOWN LEFT ARE TO PINKY FINGER. SORE ARM WHERE SHOT IS. TIGHTNESS IN SHOULDER. CALLED NURSE SAID TO WATCH IT STILL THE SAME AFTER ALL NIGIHT, STILL NUMB ANS SWALLEN BUT CAN EAT BREATH AND TALK.
55 2021-01-21 swollen extremities, lymph node swelling Severely swollen lymph nodes in armpit and chest on side of injection for 48 hours (unresolved at th... Read more
Severely swollen lymph nodes in armpit and chest on side of injection for 48 hours (unresolved at this time) Fever 100.5-100.9 x 30 hours Severe muscle and bone aching x 36 hours Chills x 18 hours
55 2021-01-21 swelling face, swelling I pretreated with zyrtec, pepside and benedryl. I had swelling on the second day in the left , my no... Read more
I pretreated with zyrtec, pepside and benedryl. I had swelling on the second day in the left , my nose, cheeks that stayed for days.
55 2021-01-21 swelling Left Groin lymph node inflammation 12 -23 - 2020 worsening over 3 weeks antibiotics started on ... Read more
Left Groin lymph node inflammation 12 -23 - 2020 worsening over 3 weeks antibiotics started on 1/12/2021
55 2021-01-22 lymph node swelling After waiting the 15min post vaccine, went to my car, I took 1 Tylenol 500mg pill and ate a banana, ... Read more
After waiting the 15min post vaccine, went to my car, I took 1 Tylenol 500mg pill and ate a banana, noticed trouble swallowing, coughed up some banana , took a drink of water. I then felt my lymph nodes in my neck were swollen. Waited another 15 min in the parking lot, went back into the to use the bathroom and to make sure symptoms were not progressing. At this point it had been approx 45min post vaccine and no other symptoms. 24 hrs later symptom had resolved.
55 2021-01-24 axillary mass On 1/20/21 awaken at 1 am with excruciating pain right arm, shoulder, neck, head and right axilla. S... Read more
On 1/20/21 awaken at 1 am with excruciating pain right arm, shoulder, neck, head and right axilla. Sever shivers, sweating, whole body aches, lethargic, nausea, loss of appetite, low grade fever, developed golf tennis ball size lump right axilla.
55 2021-01-24 oral herpes viral pinkeye; cold sores covering lips and skin around mouth; symptoms of urinary tract infection (... Read more
viral pinkeye; cold sores covering lips and skin around mouth; symptoms of urinary tract infection (UTI); Chills; elevated temp 99 degrees,/elevated temp 101.4 degrees,; This is a spontaneous report from a contactable other health care professional (patient). A 55-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration at left arm on 08Jan2021 12:45 at single dose for covid-19 immunization. The vaccine was administered at hospital. Medical history included migraine headaches. The patient had no allergies to medications, food, or other products. Concomitant medication included vitamin d3 and sumatriptan. No other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 via an unspecified route of administration on 18Dec2020 12:45 PM at Left arm at single dose for covid-19 immunization. On 09Jan2021, the patient had chills and elevated temperature of 99 degrees; on 10Jan2021, the patient had chills and elevated temperature of 101.4 degrees, symptoms of urinary tract infection (UTI); on 11Jan2021, the patient was prescribed cephalexin for UTI; on 12Jan2021, the patient had cold sores covering lips and skin around mouth; on 13Jan2021, the patient was prescribed antiviral for cold sores, the patient was developed and diagnosed with viral pinkeye, prescribed steroid eye drops. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.
55 2021-01-25 lymph node pain, lymph node swelling lymph nodes in neck swollen/tender; lymph nodes in neck swollen/tender; Swelling of lips; gums red a... Read more
lymph nodes in neck swollen/tender; lymph nodes in neck swollen/tender; Swelling of lips; gums red and swollen; gums red and swollen; soft palate; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on the left arm on 07Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical history included hyperthyroidism, menopause and COVID prior vaccination. The patient is not pregnant. Concomitant medications included salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), dexamethasone (DEXAMETHASONE), methimazole (METHIMAZOLE), estrogens conjugated (PREMARIN), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID; BETACAROTENE; CALCIUM SULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL ACETATE; RIBOFLAVIN; THIAMINE MONONITRATE; TOCOPHERYL ACETATE; ZINC OXIDE]), azithromycin (Z-PAK), and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient had no other vaccine in four weeks. The patient previously took Erythromycin (EES) and Levaquin and experienced allergies. The patient experienced swelling of lips, gums red and swollen, soft palate, lymph nodes in neck swollen/tender on 08Jan2021 at 10:00. The patient had not tested for COVID post-vaccination. No treatment was administered for the events. The events had not resolved.
55 2021-01-25 swelling, swelling face, lymph node swelling Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; ... Read more
Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Cold, chills, and felt like freezing to death; Cold, chills, and felt like freezing to death; Felt like drunk driving; Cold, chills, and felt like freezing to death; Severe headache; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 07Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included rheumatoid arthritis (RA). The patient's concomitant medications were not reported. The patient experienced cold, chills, and felt like freezing to death, felt like drunk driving, severe headache and dizziness on 07Jan2021; swollen glands, neck, face, and ear on left side on 12Jan2021; tender on an unspecified date. The patient received COVID-19 Vaccine on 07Jan2021 at approximately 11:45. She felt like drunk driving: She waited the 15 minutes and was fine. Afterwards, she got into her truck and was literally weaving. Had to really concentrate to keep the truck in a straight line. She had severe headache: Did not go into work on Friday because headache was so bad. It was almost a migraine. She could still feel it, but it was not as severe. Patient known it's five days out, but yesterday (12Jan2021) she got up and glands on left side of neck were swollen. That side of her face and ear was swollen. It was very pronounced. She still swollen today (13Jan2021). Patient stated she worked with dementia and didn't know if she should go into work when she was still swollen and tender. The patient took Benadryl (Lot: P119936, Exp: Apr2023) as Equate Allergy Relief at 25mg, two capsules at night for the reaction. The patient had been taking it every night since she received the COVID-19 Vaccine. Headache was still there. This morning woke up with swollen glands, neck, ear, and face on the left side. The outcome of events "cold, chills, and felt like freezing to death" and dizziness was recovered on 10Jan2021; of event "Felt like drunk driving" was recovered on an unspecified date; of event severe headache was recovering; of event "Swollen glands, neck, face, and ear on left side" was not recovered; of event Tender was unknown. Information on Lot/Batch number has been requested.
55 2021-01-26 lymph node swelling Chills; Enlarged lymph nodes; Body aches in her back and shoulders; Body aches in her back and shoul... Read more
Chills; Enlarged lymph nodes; Body aches in her back and shoulders; Body aches in her back and shoulders; fever of 99.6/low grade; Sore arm; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the right arm on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included urinary tract infection (UTI) from 06Jan2021 and ongoing. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), in the left upper arm with no issues. At first, she just had a sore arm on 08Jan2021. Then this morning, on 13Jan2021, she was having chills, enlarged lymph nodes, body aches in her back and shoulders, and a fever of 99.6. It is low grade but does not take much. She has been checking her temperature every 4 hours and it is not any different. She was taking paracetamol (TYLENOL) for a few days to ward anything off. Today (13Jan2021), she laid off the paracetamol to see if she really did have a fever. She did not want to mask it. So, she is taking paracetamol for that off and on. She talked to one person who said the symptoms should last 1-2 days. Then another person said they could last up to a week. She hopes that it is related to the vaccine. She will be mad if she gets COVID after doing all of this. Outcome of the sore arm was recovered on 09Jan2021 and of the remaining events was not recovered.
55 2021-01-27 lymph node pain Very painful lymphnode in arm of injection; pain radiating down arm into fingers; This is a spontane... Read more
Very painful lymphnode in arm of injection; pain radiating down arm into fingers; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 12Jan2021 at 16:00 at a single dose in the clinic for COVID-19 immunization. The patient received the first dose on 22Dec2020 at 16:00 on the left arm for COVID-19 immunization. The patient's medical history was not reported. Patient is not pregnant at the time of vaccination and did not have COVID prior to vaccination. Concomitant medication included ibuprofen and tramadol. The patient experienced very painful lymphnode in arm of injection, pain radiating down arm into fingers on 13Jan2021 at 17:00. Outcome of the events was not recovered. Information of lot/batch number has been requested.
55 2021-01-27 peripheral swelling Redness of cheeks and nose, achy joints, redness, swelling and itching of bilateral hands. Took 2 hy... Read more
Redness of cheeks and nose, achy joints, redness, swelling and itching of bilateral hands. Took 2 hydroxyzine about 6 hours apart. Symptoms resolved and did not return.
55 2021-01-27 swelling Swelling behind left ear. Mastoiditis ruled out by CT; This is a spontaneous report from a contactab... Read more
Swelling behind left ear. Mastoiditis ruled out by CT; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 08Jan2021 at 15:30 (at the age of 55-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took tetracycline hcl (MANUFACTURER UNKNOWN) and thimerosal (MANUFACTURER UNKNOWN); both on unknown dates for unknown indications and experienced drug allergy. On 12Jan2021 at 06:00, the patient experienced swelling behind left ear. The event required a visit to the emergency room and physician's office. A computed tomogram in Jan2021 ruled out mastoiditis. The patient was started on antibiotics to see if the swelling would resolve. The clinical outcome of the swelling behind the left ear was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
55 2021-01-28 lymph node swelling Woke up 11 hours after vaccinated with chills and weakness/tiredness. Felt like sandbags were weighi... Read more
Woke up 11 hours after vaccinated with chills and weakness/tiredness. Felt like sandbags were weighing me down. I also had a migraine, nausea, joint discomfort mostly in my shoulders hips, lower back and base of head. I slept most of the day into the next day and felt better approximately 46-48 hours after the vaccine administration. Slight headache continued and swollen lymph nodes in the armpit noticed day 2 and continue to this day. Alternated Tylenol 1000mg PO w/ Advil 400ng PO.
55 2021-01-28 swelling face Dizziness for 4 days Swollen face Increased Heart Rate and Blood Pressure
55 2021-01-30 lymph node swelling Fever 103.4, axillary lymph node size of an orange, symptoms beginning with slight headache proceede... Read more
Fever 103.4, axillary lymph node size of an orange, symptoms beginning with slight headache proceeded on to high temp for 24 hours and enlarged lymph node interfering with activities of daily living.
55 2021-01-31 lymph node swelling, swollen extremities edema lymph node left axilla , nausea,
55 2021-01-31 peripheral swelling After approx. 10hours of receiving the vaccine in my left arm-shoulder at work , I was sleeping and ... Read more
After approx. 10hours of receiving the vaccine in my left arm-shoulder at work , I was sleeping and was awakened With: SEVERE CHILLS - teeth chattered in my head & legs shook -uncontrollably for over 9 hours FEVER- 103 Degrees -on & off for 8 hours BURNING - STINGING - in both hands and turned red 1-2 days LEFT ARM - sore- swollen 1 week [LEFT ARM - still has aches and stiffness] HEADACHE- -top of head for 2 days JOINT PAIN -all over for 3-4 days WEAKNESS- for over 72 hours
55 2021-01-31 swelling, lymph node swelling The day after the vaccination I had redness around my whole shoulder and arm. On the third day I dev... Read more
The day after the vaccination I had redness around my whole shoulder and arm. On the third day I developed swelling of my shoulder and neck with horrible pain when I breathe. I went to urgent care and had an x-ray which was clear and they were treating me for myalgia with Motrin. I refused any narcotic pain medication or a Toradol shot. The pain never stopped on the 19th I went to Work Force Safety and reported it and I was examined by the nurse practitioner who saw all the swelling and the pain that I was in. That nurse practitioner told me if it wasn?t better in a few days to go to the emergency room to be examined. On January 23 , I developed swelling and pain went underneath my armpit it?s a burning pain that?s constant since the third day after my injection. My blood pressure was 153/104 and I was having nausea and not feeling well at all. On January 25 the pain and swelling were still there I went to work for a few hours and I went to the emergency room. They gave me lidocaine patch and Zofran for the nausea my blood pressure was 159/103 and I had an ultrasound to rule out a blood clot there was no blood clot but there was lymphadenopathy under my arm hurt and swelling and inflammation around the shoulder. The chest x-ray showed left pleural effusion / Pneumonia. My oxygen saturation was 93 and they wanted to admit me but I am a single mom with a new diabetic 14-year-old at home so they let me go home with a pulse oximeter and a prescription for doxycycline For 10 days. They called me the next day from the emergency room to follow up with a pulmonologist and cardiologist. On January 28 I saw the pulmonologist who did an ultrasound in his office and saw the fluid on my left lung. He said that most likely because the technique of the injection was so high in my shoulder that they probably had a nerve and I did have the swelling in the lymphadenopathy and all the pain and it hurt when I breathe so I wasn?t breathing correctly and I was splitting my arm against me and that?s how I probably developed plural effusion and pneumonia. I am following up with him on February 4. I still have shortness of breath and my oxygen saturation is 93. I am also on two inhalers that the pulmonologist ordered.
55 2021-02-02 anaphylactic reaction Systemic: Anaphylaxis-Severe
55 2021-02-03 lymph node pain, lymph node swelling I got my first Covid19 shot (Pfizer) at noontime on Wednesday January 27, 2021 12 hours later, abou... Read more
I got my first Covid19 shot (Pfizer) at noontime on Wednesday January 27, 2021 12 hours later, about 12pm I start having side effect: Left Arm sore, hurt to lift (arm that was injected) Farting up a storm in my sleep Wednesday night, waking me up constantly, horrible weird smell, my poor husband, I moved to the couch and stunk up the first floor. Then diarrhea few hours later, about 4am, slight intestinal cramps, not bad. I was able to get ready and go to work for 6am. On Thursday January 28 Farting was over, thank goodness. As the morning went on I felt like I did when I originally had the Covid19 in May. I had to leave work at 10:30am due to: aches every where in body Especially neck hurt My left arm hard to lift or use (injection was in left arm), hard to think and concentrate (brain fog), chills Able to eat some soup Slept several hours at home, felt slightly better, than slept nine hours that night On Friday January 29th felt much better and arm hurt less to lift it. On Saturday January 30th Under my arm, glands are swollen and hurt to touch. All other symptoms have subsided Sunday January 31, glands under arm are better, much less sore Monday February 1st glands under arm, back to normal
55 2021-02-03 peripheral swelling After an hour and a half to two hours after injection, I began to have an allergic reaction but it w... Read more
After an hour and a half to two hours after injection, I began to have an allergic reaction but it was slight. Cheeks turned red and under right eye was slightly swollen and slightly itchy it continued for about 45 min and then my feet and lower legs began to feel the same. The tops of my feet were red for approximately 10 min and then all symptoms subsided. No other problems afterwards
55 2021-02-05 lymph node swelling Arm pain radiating to forearm, muscle pain in armpit area, swollen lymph armpit area left side of br... Read more
Arm pain radiating to forearm, muscle pain in armpit area, swollen lymph armpit area left side of breast
55 2021-02-05 lymph node swelling All over achiness, low grade fever (100), swollen lymph nodes right side of neck and above collar bo... Read more
All over achiness, low grade fever (100), swollen lymph nodes right side of neck and above collar bone on right side
55 2021-02-07 swelling Patient started by complaining of a metallic taste in their mouth shortly after administration. a fe... Read more
Patient started by complaining of a metallic taste in their mouth shortly after administration. a few minutes later it had evolved into numbness and tingling across the entire mouth and down the throat. Physical exam presented mild swelling
55 2021-02-08 swelling face Slight swelling and tingling of lips, cheeks, and tongue. Lasted about 20 - 30 minutes from onset.... Read more
Slight swelling and tingling of lips, cheeks, and tongue. Lasted about 20 - 30 minutes from onset. Consulted EMTs onsite but as no difficulty breathing and symptoms were reducing, nothing administered by EMTs.
55 2021-02-08 swelling SWELLING, REDNESS, PAIN AT SITE, VERY TIRED
55 2021-02-10 lymph node pain, lymph node swelling My lymph node under my left arm is swollen to the size of a big lemon & it hurts. My bra bothers it.
55 2021-02-13 lymph node swelling Swollen glands in neck
55 2021-02-14 lymph node pain, lymph node swelling At 725 pm was extremely tired. Went to bed. Woke up at 1030 pm with out of control shaking and fev... Read more
At 725 pm was extremely tired. Went to bed. Woke up at 1030 pm with out of control shaking and fever of 102. Body aches and pains. Had to put on extra clothes and blankets. Went to work in am but had to leave early due to ongoing body pains and fever of 101. Also, inflamed lymph node in axilla of shot arm- very painful. Felt better by Sat late morning. Please note I am strawberry blonde as is coworker who had same response. Other individuals with us with very mild symptoms.
55 2021-02-14 lymph node swelling Left supraclavicular adenopathy of significance including virchow's nodes. (Also a fever, that was ... Read more
Left supraclavicular adenopathy of significance including virchow's nodes. (Also a fever, that was expected, of 100.7.)
55 2021-02-17 anaphylactic reaction anaphylactic reaction; Chest tightness; This is a spontaneous report from a contactable consumer. A ... Read more
anaphylactic reaction; Chest tightness; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261), via an unspecified route of administration on 30Jan2021 09:30 at single dose for covid-19 immunisation. Medical history included severe peanut allergy. Concomitant medication included diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), both for severe peanut allergy. She went to the Emergency Room after having an anaphylactic reaction on 31Jan2021. She was in the emergency room for four hours. She has taken Solu-Medrol and Benadryl. She has a severe peanut allergy that she had this medication for it. The anaphylactic reaction last for 24 hours. She also experienced chest tightness on 31Jan2021 that continued. She was given Epinephrine, Solu-Medrol and Benadryl in the ambulance. Therapeutic measures were taken as a result of anaphylactic reaction and chest tightness. The outcome of anaphylactic reaction was recovered on 31Jan2021, for chest tightness was not recovered. No follow-up attempts are possible. No further information is expected.
55 2021-02-17 lymph node swelling, lymph node pain lymph node soreness size of small orange/enlarged lymph node; Fever of 103.4/Day 3 still temp of 100... Read more
lymph node soreness size of small orange/enlarged lymph node; Fever of 103.4/Day 3 still temp of 100; lymph node soreness size of small orange; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) on her left arm, via an unspecified route of administration on 29Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included asthma. Patient previously took codeine and experienced allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 (first dose). The patient experienced Fever of 103.4 lymph node soreness size of small orange on 30Jan2021 at 01:00AM. Day 3 still temp of 100 and enlarged lymph node. The patient also had a covid test on 24Jan2021 which tested negative.
55 2021-02-17 lymph node swelling Lump under the armpit (possible enlarged lymph node) for about 5 days. Intense heartburn or chest ... Read more
Lump under the armpit (possible enlarged lymph node) for about 5 days. Intense heartburn or chest tightness 3 days after the vaccination - unsure if it's related to vaccine. Resolved overnight.
55 2021-02-18 swelling High degree of swelling
55 2021-02-20 lymph node swelling 12/29 vaccination 1/7 I noticed the swelling in L arm pit; golf ball size. Tingling down arm. 1/8 P... Read more
12/29 vaccination 1/7 I noticed the swelling in L arm pit; golf ball size. Tingling down arm. 1/8 PCM; ball of fluid with hard lymph nodes. Put on antibiotics for 14 days. 1/11 mammogram; negative/zero abnormalities. Lymph nodes WERE VERY enlarged; verified.
55 2021-02-21 lymph node pain, lymph node swelling FIRST ROUND ONLY A SORE ARM FOR A FEW DAYS. SECOND ROUND ON 2/20/21 AFTER A FEW HOURS I STARTED TO H... Read more
FIRST ROUND ONLY A SORE ARM FOR A FEW DAYS. SECOND ROUND ON 2/20/21 AFTER A FEW HOURS I STARTED TO HAVE HOT FLASHES WITH FEELING THE CHILLS.. IN THE EVENING MY LEFT HAND WAS LIKE ICE BUT MY RIGHT SIDE WAS NORMAL AND WARM. CHILLS / NO FEVER . COLD HAND WAS GONE IN THE MORNING.. ABOUT 5 AM HORRIBLE HEADACHE WITH BLURRED VISION... TOOK TYLONAL AT 9AM.. FELT BETTER BY 11AM. CHILLS/AND SLEPT MOST THE DAY. I DO NOT BELIEVE I EVER HAD A FEVER. SUNDAY LEFT ARMPIT LYMPH NODES SWOLLEN AND SORE. MONDAY FEELING BETTER BUT LYMPH NODES STILL ACHE LIKE A BRUISE. I DO NOT BELIEVE I EVER HAD A FEVER.. JUST CHILLS. OH>>>. RIGHT SIDE OF MY NECK WAS STIFF FOR A BIT THE FIRST DAY.
55 2021-02-21 lymph node swelling Cold sweating, lethargy, nausea and vomiting , swollen lymph nodes under left arm. Lasting a little... Read more
Cold sweating, lethargy, nausea and vomiting , swollen lymph nodes under left arm. Lasting a little over 48 hours. Lymph nodes under left arm are still slightly swollen.
55 2021-02-23 lymph node swelling Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Me... Read more
Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: She had a horrible taste in her mouth
55 2021-02-26 lymph node swelling Swollen lymph node (R axillary) burning sensation in armpit/radiating down arm, fatigue, joint pain.
55 2021-02-28 swelling Angioedema (both eyes swollen shut) took medication prescribed by primary care physician; resolved i... Read more
Angioedema (both eyes swollen shut) took medication prescribed by primary care physician; resolved inn48 hours
55 2021-02-28 peripheral swelling severe pain and swelling in left lower leg. Diagnosed with 2 DVTs 3 days later in emergency room.
55 2021-03-01 swelling face Per patient's report: She received her first dose of Pfizer COVID-19 vaccine and developed soreness... Read more
Per patient's report: She received her first dose of Pfizer COVID-19 vaccine and developed soreness at localized injection site and felt sleepy, otherwise no adverse reaction signs or symptoms patient reported. On 2-19-21 at 2:30 PM she received her second dose of the Pfizer COVID-19 vaccine at a mall. She reports the lot number of the vaccine was EL9269. She was monitored for 15 minutes after receiving the second dose. She and her husband left and took the car to a car wash where she fell asleep on her way home and her husband woke her up when they got home. At about 320 or 3:25 PM, she noticed that her face felt puffy and she had a sensation that her face was sliding down, she developed tongue swelling, blurry vision, dizziness, and she reports that she was talking funny/slurring her words. Her husband got a flashlight and looked in her throat and said that her throat was swelling. She felt like falling asleep. Her husband used her EpiPen on her. The EpiPen worked right away to improve the symptoms. She took no other treatments at home. Her husband drove her to the hospital where she slept the entire way. She never developed rash, flushing, skin itching, wheezing, coughing, chest tightness, shortness of breath, nausea, vomiting, diarrhea, fevers, chills, or joint pains. She does not know if she passed out, she states it was hard to stay awake. She reports having some abdominal cramping and churning for the following 2 to 3 days afterwards. She was discharged from the hospital ED where she was never admitted. They gave her an albuterol inhaler to use every 4 hours for 6 days after she left the ED. She went home at about 10:00 PM and went to bed about 10:30 PM. She woke up at 3:00 AM crying and then fell back asleep and woke up again around 7:30 AM. She did not develop any local injection site reactions on her arm this time.
55 2021-03-05 lymph node swelling, lymph node pain, peripheral swelling Extreme pain in right arm, worst in arm pit. Lymph nodes area. Started 25hrs after injection. Inc... Read more
Extreme pain in right arm, worst in arm pit. Lymph nodes area. Started 25hrs after injection. Including fever. Fever gone in 12 hours. Lymph node pain and swelling continues including bruising under right arm. Left arm swelling very minimal but right nodes continue to get worse 3 days in. Today
55 2021-03-06 lymph node pain Oralpharynx irritated, mild itchy sensation within 5 mins of injection. Did not resolve or worsen. ... Read more
Oralpharynx irritated, mild itchy sensation within 5 mins of injection. Did not resolve or worsen. Resolved after taking an antihistamine about an hour later. Took 1 Alavert. Next morning started feeling generally unwell with body aches, fatigue, mild chills. Took Tylenol or Advil every 4-6 hours for 36 hours after injection which helped symptoms. Axillary lymph nodes on injection side became tender and sore in about 24 hours after injection and lasted about a week before resolving.
55 2021-03-06 lymph node swelling Bump under left arm pit,- very sore, body aches
55 2021-03-07 lymph node swelling Swelling of lymph nodes in neck by the throat and sinuses feel stuffy. Feel tired.
55 2021-03-07 swelling, lymph node swelling 1st Dose: No problem; just a bit of fatigue 1 day following inoculation. 2nd Dose: My shot was sch... Read more
1st Dose: No problem; just a bit of fatigue 1 day following inoculation. 2nd Dose: My shot was scheduled for 3:40 PM, but probably didn't receive until 4:20 PM. At night, I had insomnia. The next morning, my fever went up to 101.2, I had swelling of the neck, my arm @ injection site, swollen lymph nodes in my left armpit, body aches, occasional stabbing pains in random places (back, arm, leg, etc.), extreme fatigue, it lasted for 1.5 days and then the fever dropped to 99. By the second day the fever was gone, body aches gone & only thing left on day 2 is swollen lymph nodes in arm pit, arm soreness at inoculation site, and fatigue. Day 3 slight fatigue, a bit of soreness in arm and armpit.
55 2021-03-08 peripheral swelling Thirty hours in, I had joint aches in my spine (mainly neck and low back); low grade fever; nauseate... Read more
Thirty hours in, I had joint aches in my spine (mainly neck and low back); low grade fever; nauseated; headache. I felt like everything was it was swollen and tight - I couldn't wear my watch on my wrist. Almost like lymph system - nothing tight in my arm pits; felt like my pants were too tight in my groin - my body was swollen by my lymph nodes. Developed all kinds of gas in my stomach. I was having chest pains - 3 or 4 times a month before the vaccine - after the vaccine - I'm having the chest pains daily. That lasted for about 12 hours. Next day, 22nd, I developed diarrhea for 24 hours. 9 days later - I got numbness and tingling started radiating down my wrist into my fingers; lower calf to my feet and I had to go see my orthopedic surgeon - it was radiating down into my feet. He sent me to a podiatrist and he doesn't know. Those symptoms still haven't resolved. When I wake up - it's a low level and by night time my feet would get so numb and tingly it drove me crazy and then it went into my hands. Went to my doctor on March 2nd - my doctor thought I was having a histamine response in my body. I took an antihistamine - and half my symptoms went away. My esophagus is going into spasms - and I am trying to see a GI specialist. I was taking Benadryl last week but I got too tired. So I take 2 Benadryl at night now and I'm taking a Zyrtec (generic) at the day - it takes the edge off but doesn't resolve the symptoms entirely. Eleven day - I developed a floaty in my right eye - a black spot. I went to my eye doctor - it looks like my eye is healthy -but floaty is not going away. So talking on the phone, My throat is starting to swell up and feels like something back there and the more I talk pretty soon I start losing my voice (happening now on the phone). They added to my meds: Pepsid, Viscus lidocaine; Mylanta after every meal; Pantoprazole; Sucralfate; gave me another one but I haven't taken it yet: Hyoscyamine - for really bad spasms and I haven't had another really bad one since I went to ER (besides taking the antihistamines). I have seen 5 specialists all together.
55 2021-03-10 lymph node swelling Swollen lymph nodes from left breast and under my left arm pit and hot to the touch.
55 2021-03-10 peripheral swelling, swelling Swelling on the skin of the chest, arms and leg the day after the injection lasting until the next d... Read more
Swelling on the skin of the chest, arms and leg the day after the injection lasting until the next day. Tingling in the mouth for about an hour and a half on the same day.
55 2021-03-12 lymph node swelling swollen lymph node in the left armpit received the vaccine in the left arm.
55 2021-03-13 lymph node swelling Headache and fatigue beginning the evening of March 13th, Early the morning of the 14th, woke to my... Read more
Headache and fatigue beginning the evening of March 13th, Early the morning of the 14th, woke to myalgias and body aches. Low grade fever. Swollen lymph node in right shoulder. Some relief with Motrin.
55 2021-03-14 lymph node swelling Left arm pain day after injection followed by left arm pit swelling of gland with pain, low grade fe... Read more
Left arm pain day after injection followed by left arm pit swelling of gland with pain, low grade fever,headache.
55 2021-03-14 swelling face About 5 minutes after injection I had stiffness in right hand and neck and shoulders. The stiffness... Read more
About 5 minutes after injection I had stiffness in right hand and neck and shoulders. The stiffness started to go away at 20 minutes later. 15 minutes after I left test site (35 minutes after injections, my tongue, lips, and face started swelling and had trouble swallowing an hour later). I ate a frozen popsicle and the swelling in tongue and lips started to go down. Hours later I took my blood pressure medicine (Lisinopril) I started to have tightness in face and jaw area, burning sensations in ears, jaws and back of my head and headaches. I contacted health care provider after hours number. They scheduled a video appointment with doctor. The doctor advised me not to take blood pressure and any other medications for another day and to put warm compressor on shoulders to relieve some of the tightness in jaws. I was also advised to call 911 or immediately come to healthcare facility if swelling re-occurred. A follow up appointment with primary care provider is scheduled on 3/17/21. I do not have any symptoms at the time of this report, March 15, 2021 at 1:23 pm.
55 2021-03-16 swelling 4 days psot vaccine patient developed eye angioedema and hives resulting in ED visit. 6 days post v... Read more
4 days psot vaccine patient developed eye angioedema and hives resulting in ED visit. 6 days post vaccine she devleoped flu like sxs with positive covid 19 test results on day 8 post vaccine as per pateint. 10 days post vaccine patient with dyspnea and hypoxemia-admitted to hospital.
55 2021-03-17 swelling Following vaccination in R arm felt tightness in her R hand and back of her neck within 5 min, staye... Read more
Following vaccination in R arm felt tightness in her R hand and back of her neck within 5 min, stayed for observation for about 20min and was feeling better so left - but about halfway home lips started to swell, tongue started to feel thick and throat started hurting - ate a popsicle which seemed to help. Then that evening took her usual dose of lisinopril and about an hour later noticed tightness developing in her neck and new headache, followed by swelling of lips and tongue. Took tylenol arthritis which she usually takes for her neck problems, and went to bed, but a couple of hours later developed burning in her ears and jaw, headache persisted, and swelling seemed to have gone down with ice chips. Lisinopril d/c'd on 3/14, converted 3/17 to losartan which she started at 5pm and within 2 hours had recurrent angioedema for which she was told to call emergency responders, used EpiPen, discharged from ED after 4 hours with another change in BP medication and Medrol dosepak. Allergist recommends no further COVID vaccines.
55 2021-03-18 swelling face AFTER I LEFT THE VACCINE SITE ABOUT 5 MIN LATER MY FACE AND LIPS STARTED TO SWELL. THE LIP SWELING R... Read more
AFTER I LEFT THE VACCINE SITE ABOUT 5 MIN LATER MY FACE AND LIPS STARTED TO SWELL. THE LIP SWELING RESOLVED ABOUT 15 MINS AFTER ONSET AND THE FACIAL SWELLING ABOUT AN HOUR AFTER ONSET.
55 2021-03-19 lymph node swelling, lymph node pain The day following the vaccine, I began to feel pain underneath my arm pit. The next morning when I ... Read more
The day following the vaccine, I began to feel pain underneath my arm pit. The next morning when I woke up, the lymph nodes underneath my arm were swollen and painful.
55 2021-03-19 lymph node swelling With 24 hours pain at site of injection that traveled through shoulders and neck. Severe neck pai... Read more
With 24 hours pain at site of injection that traveled through shoulders and neck. Severe neck pain/swollen glands/- 2 days later pain traveled to mouth and throat- on day 5 in the evening starting run a fever with severe night sweats/Chills/no appetite/fatigue . I have never experienced this feeling before --- the amount of sweat coming out of my body was like a demon was being released. I felt these severe symptoms for about 4 days . One week later from onset of night sweats/c hills/ fatigue I still have these symptoms but not as severe.
55 2021-03-19 swelling face, swelling Swelling of face and neck, eyes itchy, red rash on face and large patches of rash on face, neck and ... Read more
Swelling of face and neck, eyes itchy, red rash on face and large patches of rash on face, neck and chest.
55 2021-03-20 lymph node swelling enlarged anterior axillary lymph node; My breast tumor grew to size of golf ball in six months; This... Read more
enlarged anterior axillary lymph node; My breast tumor grew to size of golf ball in six months; This is a spontaneous report from a contactable other health care professional. A 55-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL0142), intramuscular, administered in Arm Right on 12Jan2021 08:00 AM and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3249) intramuscular, administered in Arm Right on 29Jan2021 08:00 AM as single dose for COVID-19 immunisation. Medical history included breast cancer, restless legs syndrome, insomnia, hypertension, PALB2, CKD, NF1, and few known allergies to codeine, Morphine and Mollusks from an unknown date and unknown if ongoing. The patient's concomitant medications included Lasix, Kdur, anastrozole, requip, Metoprolol, trazadone, nortriptyline, melatonin, MV, Vit C. On 23Jan2021 04:00, the patient experienced enlarged anterior axillary lymph node and reported my breast tumor grew to size of golf ball in six months on an unspecified date. approximately 7-10 days following first injection on 12Jan2021 noted an enlarged anterior axillary lymph node. I watched it for approximately one week. It was slightly larger but definitely not smaller Received 2nd covid vaccine on 29Jan2021. notified provider on 01Feb2021 ordered US done 09Feb2021. I have PALB2 mutation, breast cancer post chemo, a RUL and LLL lung nodules. I am being told it is from my first Covid vaccine and to recheck in two months. My breast tumor grew to size of golf ball in six months. I am unsure of exact date it became enlarged or what day i noticed it. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events Not recovered.
55 2021-03-21 lymph node swelling 48 hrs after vaccination severe stomach cramps/pain after eating spicy food (curry) 4 days after va... Read more
48 hrs after vaccination severe stomach cramps/pain after eating spicy food (curry) 4 days after vaccination severe stomach cramps/pain after eating spciy food 4 days after vaccine armpit of vaccine site arm (left) had dark/purpleish discolored area about 5 cm and moderate swelling . Discoloration has now resolved, slight swelling remains.
55 2021-03-22 peripheral swelling, swelling, lymph node pain Headache, Angioedema, SWOLLEN FINGERS, LYMPH NODE PAIN, INJECTION SITE PAIN Narrative:
55 2021-03-22 swelling face face swelling, rash on cheeks, eyes,nose, sore arm,
55 2021-03-23 axillary mass 3/22/21: Pain and swelling at injection site around 4p. Chills, nausea and extreme exhaustion around... Read more
3/22/21: Pain and swelling at injection site around 4p. Chills, nausea and extreme exhaustion around 5p. Just got in the bed to sleep off the symptoms about 6:15p. 3/23/21: Pain and swelling at injection site persisted. Also had pain under left arm that radiated to left breast, down left side, up the neck and upper left back as day progressed. Went to take a shower around 4:30p and noticed the lump/swelling under left arm, beside left breast. Area of the lump was tender to the touch. Went to Patient first to get checked out and was prescribed steroids to reduce the pain, swelling and inflammation.
55 2021-03-23 swelling face Numbness and swelling in left cheek and under chin, feeling faint.
55 2021-03-23 white blood cell count increased Day of shot developed pain in entire right side(chest area), also acid reflux and nausea. That went ... Read more
Day of shot developed pain in entire right side(chest area), also acid reflux and nausea. That went away about 12 hours after the vaccine. Ten days after I developed a slight pain in right lateral side that progresses to constant pain in 2 places on right side including under right clavicle. I had pain upon taking in a deep breath. Saw MD after 4 days of these SXS. Performed labs, Chest x-ray and EKG. All were essentially normal except elevated WBC count. Have 2 COVID test which were both normal. Md said possibly some sort of inflammation and suggested taking anti-inflammatories which did not help much at all with SXS. After a few more days the SXS changed to constant chest pain(pressure), SOB upon exertion and pain behind knee. F/U with MD again and it was decided to wait a few more days. Upon suggestion from friend asked MD to perform D-Dimer lab test. The result was 4,400. My normal value should have been 550. Sent to ER. CT of chest, EKG and more labs performed. CT revealed large bilateral pulmonary embolisms in pulmonary arteries. Started on blood thinners. Ultrasound of left leg revealed large DVT. Sent home after 2 days on blood thinners. SXS stopped after a few days.
55 2021-03-24 peripheral swelling, swelling, swelling face Patient is been complaining of swollen arms, breast, face and neck. she's also having burning sensat... Read more
Patient is been complaining of swollen arms, breast, face and neck. she's also having burning sensation all over body, especially breast area. Patient has also blue spots on upper Thigh. Patient also complaining of weakness, body aches, and abdominal pain sometimes. Patient also today is complaining about head ache and feeling confused.
55 2021-03-24 peripheral swelling Patient's hands started swelling about five minutes after receiving vaccine. No signs of allergic re... Read more
Patient's hands started swelling about five minutes after receiving vaccine. No signs of allergic reaction on trunk or airway. Patient took 50 mg of diphenhydramine and was observed in the pharmacy for 30 minutes. No worsening of symptoms over that time. Reported event to physician. Followed up with patient two hours later, no worsening of symptoms and swelling was almost gone.
55 2021-03-25 anaphylactic reaction pt stated that she felt a little funny and lightheaded after taking the covid vax. Her skin started... Read more
pt stated that she felt a little funny and lightheaded after taking the covid vax. Her skin started feeling a little prickly and she developed rash on her extremities and upper chest. She started having trouble speaking, her voice got hoarse and she started coughing. She had an intense headache, fatigue and could barely speak. She was taken to the UrgentCare . She was given EPI pen and steroids injections. Paramedics were called and she was taken to a hospital, where she was monitored after getting those injections and given Pepcid and IV fluids. She was diagnosed w/ Anaphylaxis from adverse reaction to vaccine. She discharged and sent home to FU w/PCP. Her appt w/ her PCP on 3/25/2021 she was taken next door by wheelchair to all allergist Dr. She noticed that her respiratory symptoms were improving while she was there as her Pepcid medication was wearing off. Pt is convinced that she is allergic to the ingredient Polyethylene Glycol. She is still taking prednisone medication and continuing to improve.
55 2021-03-25 lymph node swelling INCREASE IN BLOOD PRESSURE 50 POINTS, AND INCREASE IN HEARTRATE 30 POINTS IN FIRST 30 MINUTES SORE A... Read more
INCREASE IN BLOOD PRESSURE 50 POINTS, AND INCREASE IN HEARTRATE 30 POINTS IN FIRST 30 MINUTES SORE ARM AT INJECTION SITE DAY 2, FATIGUE DAY 2, NAUSEA AND EASILY DEHYDRATED DAY 2-5 SWOLLEN LYMPH NODES DAY 8-10 ON RIGHT SIDE ONLY
55 2021-03-25 lymph node swelling Achiness through upper torso plus a lump in arm pit of left arm. Rubbed self down with arnicare f... Read more
Achiness through upper torso plus a lump in arm pit of left arm. Rubbed self down with arnicare for achiness the day following shot, cleared up that situation within. Iced the lump at the same time but still tender on 2nd day continue to ice off and on.
55 2021-03-25 swelling Having all kinds of trouble in walking; sick on my stomach and was throwing up; sick on my stomach a... Read more
Having all kinds of trouble in walking; sick on my stomach and was throwing up; sick on my stomach and was throwing up; Pain; sick on my stomach and was throwing up; Headache; Hips, legs and neck is a little swelled; my hip down were pain; arm was very sore; could not move arm; arm was very sore; could not move arm; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received second dose of BNT162B2 (pfizer-biontech covid-19 vaccine, Formulation: solution for injection, lot number: EL3246; Expiration Date: 30Apr2021) via intramuscularly on right arm as single dose on 14Jan2021 for covid-19 immunisation. The patient received first dose on 24Dec2020 and she didn't have any reaction, no nothing. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient work at the hospital in the kitchen and don't have any health issues before, none. Laboratory data included, Multiple blood work, 3 MRIs, Chest X-ray, EKG, EMG. On 15Jan2021, after receiving second dose patient stated, it's been almost a month, she had all kinds of trouble, in walking, hips, legs and neck is a little swelled. she had a major headache the last four days, her arm was very sore, she was sick on her stomach, she was throwing up. The next day she could hardly walk. She used a walker. She was out of work and did physical therapy, from her hip down were pain and was hard to walk and it spend like that for a month now and it's now 17Feb2021. Patient hospitalized cause she couldn't walk. She spent six days in a hospital (28Jan2021 to 3Feb2021), they are not sure if it is related to that. They are not even sure what's going on. They can't tell what's wrong. Patient started the treatment with "Gabapentin-300 mg, twice a day, still taking, start date: Consumer stated, " she don't remember. Acetaminophen-codeine 3-1 tab every 6 hours as needed, still taking, start date: Consumer stated, "Last week, I don't know." She was just wondering why she had all these side effects. The outcome of the event she was sick on her stomach was unknown and all of the event was not recovered.
55 2021-03-28 lymph node swelling Chills and tiredness the day after on Sunday. Sunday evening noticed the lymph nodes in my armpit of... Read more
Chills and tiredness the day after on Sunday. Sunday evening noticed the lymph nodes in my armpit of the arm I received the shot in were swollen and sore. Still experiencing it today(Monday).
55 2021-03-28 peripheral swelling upon injection felt the heat of medication 230 pm 3/25/2021 felt dizzy, with headache, and neck pain... Read more
upon injection felt the heat of medication 230 pm 3/25/2021 felt dizzy, with headache, and neck pain 600 pm 3/25/2021 swelling of arm, felt the heat on injection area, headache persistence, having heat flashes through the night & morning 9am 3/26/2021 headache comes and goes, arm still the same very sore, heat flashes persistence, dizziness, 3/27/2021 symptoms still all the same, seek medical attention from my primary doctor 3/28/2021 received prescriptions acetaminophen 500mg and meclizine
55 2021-03-28 swelling Per EMS, " very mild rash/bumps that began to come up while in observation area. Patient's vitals we... Read more
Per EMS, " very mild rash/bumps that began to come up while in observation area. Patient's vitals were assessed and within normal limits. No SOB, chest pain, or low blood pressure." She was given oral Benadryl 25 mg to self-administer and reported relief felt.
55 2021-03-29 lymph node pain, lymph node swelling Painful and tender area in armpit of the arm that got the shot. Assuming lymph node swollen and tend... Read more
Painful and tender area in armpit of the arm that got the shot. Assuming lymph node swollen and tender.
55 2021-03-29 swelling Since having the shot, I have noticed a great amount of swelling in my neck, even making it hard for... Read more
Since having the shot, I have noticed a great amount of swelling in my neck, even making it hard for me to breath at night when laying down to sleep. I also feel heart palpatations, even when laying down and it feels like irregular or racing heart rate, to the extent that I have to sit up and focus my mind on calming my heart rate. I also feel easily out of breath even in doing small activities. I have a lack of energy and I am sleeping a lot and still always feeling tired, I also have brain fog unless I drink a ton of coffee. I have no mental clarity for much of the day. I wonder if I will ever regain my full health prior to getting the shot. I also got really sick about 2 weeks after the shot with a really sore throat and chills and I didn't get better even when taking antibiotics. It's been a few weeks, and I am still not feeling normal.
55 2021-03-30 anaphylactic reaction Anaphylaxis, confirmed by ER; This is a spontaneous report from a contactable other healthcare profe... Read more
Anaphylaxis, confirmed by ER; This is a spontaneous report from a contactable other healthcare professional (HCP). A 55-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6200, expiration date was unknown), intramuscularly, administered in the left arm on 19Feb2021 at 12:15 PM as a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. The patient's medical history and concomitant medications were not reported. The patient previously took codeine and hydrocodone bitartrate, paracetamol (VICODIN), from which she had known allergies. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She was not tested for COVID post vaccination. On 19Feb2021 at 12:15 PM, the patient experienced anaphylaxis, confirmed by emergency room (ER). The adverse event (AE) resulted in a doctor or other HCP office/clinic visit and emergency room/department or urgent care visit. Therapeutic measures were taken as a result of anaphylaxis, confirmed by ER, which included epinephrine, steroids, and antihistamines. The patient recovered from the event on an unspecified date.; Sender's Comments: Based on known drug safety profile and temporal association, the causal relationship between bnt162b2 and the event anaphylactic reaction cannot be excluded.
55 2021-03-30 lymph node swelling Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe nec... Read more
Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe neck pain; right cheek numb/sometimes left cheek numb feeling in lower cheeks/numbness in chin; hot flash in ears; chest pain; intense shoulder/shoulder pain/elbow pain; feels like it runs up the nerves; Pain in shot site left arm and pain in right arm in the same; severe headache/intense headache/pressure headache/bad headache; body pain at night; Pain in shot site left arm and pain in right arm in the same; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm at the age of 55-years (non-pregnant at the time of vaccination), on 06Feb2021 at 01:45 PM at a single dose for COVID-19 immunisation. The patient's medical history included diabetes, high blood pressure, lacunar infarct, anemia, and non-rheumatic mitral regurgitation. The patient had no known allergies. Concomitant medications included losartan, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and acetaminophen. The patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. It was reported that Immediately after the shot, severe neck pain that wrapped up my face, right cheek numb, hot flash in ears, chest pain, intense shoulder, elbow pain, feels like it runs up the nerves, severe headache, ear pressure, lymph node swollen behind right ear on 06Feb2021 at 01:45 PM. Headache, body pain at night on 06Feb2021. O7Feb2021, numbness in right cheek, sometimes left cheek numb feeling in lower cheeks and intense headache. On 08Feb2021, ear pain, pressure headache, shoulder pain, cheeks numb left work early not feeling good at all headache very bad with acetaminophen (TYLENOL). Second vaccine shockingly painful side effects day of shot and days after. Pain in shot site left arm and pain in right arm in the same. Temp elevated night 100.9 F. On 09Feb2021, Off work vice grip headache, ear pain. On 10Feb2021, bad headache, numbness in cheeks remain, numbness in chin. The outcome of the events was recovering. It was also reported that post vaccination, the patient had not been tested for COVID.
55 2021-03-30 peripheral swelling, anaphylactic reaction hands got very swollen and rash and itchy beyond itch; hands got very swollen and rash and itchy bey... Read more
hands got very swollen and rash and itchy beyond itch; hands got very swollen and rash and itchy beyond itch; Anaphylaxis; Double vision; Right eye is going cross eyed/Left eye is dropping; Right wrist pain increased dramatically after the vaccine; Throat starting to close/Throat started tightening; severe rash- latus stranding, purple dots, and hives from face all the way down to toes; severe rash- latus stranding, purple dots, and hives from face all the way down to toes; This is a spontaneous report from a contactable consumer (the patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 19Feb2021 10:00 (Batch/Lot Number: EN6201), at the age of 55 years, as single dose for covid-19 immunisation. Medical history included ongoing asthma diagnosed 3 years ago, ongoing gastrooesophageal reflux disease diagnosed 4 years ago, ongoing hypertension diagnosed 4 years ago, ongoing food allergy: allergic to eggs, shellfish, dairy/lactose intolerant, ongoing allergies to environmental: standard- hay fever, dust, mold, ongoing allergies to dogs and cats, contrast media reaction (IV contrast CT scan dye- respiratory distress, throat tightens), urticaria, pruritus. She had Covid on 18Dec2020 and "Covid rash it attached her muscular system. She had muscular pain in the wrist and hip on the right side and mild double vision." The patient previously took vitamin k 2 and experienced anaphylactic reaction, Toradol and experienced urticaria, influenza vaccine and experienced rash at the injection site, at the age of 34 years (because she's allergic to eggs). The patient received the first dose of bnt162b2 on 29Jan2021 Lot: EL3247; 9:30 AM; Right arm for covid-19 immunisation and she did not have any symptoms whatsoever with the first shot. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. Vaccination Facility Type: Hospital. Concomitant medications included omeprazole taken for gastrooesophageal reflux disease; lisinopril taken for hypertension; montelukast sodium (SINGULAIR) taken for asthma; salbutamol sulfate (INHALERIN) taken for asthma; start and stop date were not reported for all. The patient experienced anaphylaxis on 26Feb2021 with outcome of unknown, throat starting to close/throat started tightening on 19Feb2021 with outcome of recovered, severe rash- latus stranding, purple dots, and hives from face all the way down to toes on 19Feb2021 with outcome of not recovered, double vision on 20Feb2021 with outcome of not recovered, right eye is going cross eyed/left eye is dropping on 20Feb2021 with outcome of not recovered, right wrist pain increased dramatically after the vaccine on 20Feb2021 with outcome of not recovered, hands got very swollen and rash and itchy beyond itch on an unspecified date with outcome of unknown for Hand swelling and recovered for Localised itching. Therapeutic measures were taken as a result of the events: Benadryl, Zyrtec, Pepcid, New glasses for double vision, Prednisone 7 day ween. The patient underwent lab tests which included Hematology test on unknown date with unknown results; Immune markers on 11Mar2021 with unknown results. Clinical course: The patient received the vaccine on 19Feb2021at 10:00 AM and five minutes after, her throat started tightening and they put her in observation for another hour and then her throat felt fine and they let her go. Caller confirmed she was not referring to this occurrence as anaphylaxis. The anaphylactic reaction occurred days later. She mentioned from 19Feb2021-26Feb2021, her symptoms were progressing and then on 26Feb2021, it was full blown out; the actual anaphylaxis was 26Feb2021. Between this, she had severe double vision, severe rash from face all the way down to toes, one eye going cross eyed (right eye), left eye is still drooping. On 20Feb2021, she started having double vision that started with the sunlight and fluorescent lights and the next day she couldn't see anything without double vision, and her eye started going cross eyed. She still cannot see normally now. She is under eye doctor care for that too. The patient was treated with Epi-Pen into leg and then into the Emergency Room. She received 50 mgs of Benadryl and 125 mg of Solu-Medrol IM injection, but still have to give Epi because her throat was still closing. Her airway was intact and no nebulizer treatment needed. The patient reported also that her hands got very swollen and rash and itchy beyond itch. The patient reported that her weight at that point was 204, the she had been on Prednisone for a week, and her weight has gone up to 210 now. After her throat closed on the 26Feb2021, caller reports she gained 7 pounds while on it for one week. Caller stated she was also put on prednisone when she got diagnosed with asthma, reactive airway. She confirmed her throat stop closing immediately after the Epi. The patient was also treated with 25 mgs of Benadryl, Zyrtec, and Pepcid a day. Outcome for throat closing was improved with medication. Outcome for rash was not improved and she is taking medicine to counteract it; itch went away when she took the Zyrtec. Regarding right wrist pain, it increased dramatically after the vaccine. Caller reports it felt like a spiral fracture down the ulna and it started to ache on 20Feb2021, by the next day it hurt a 5 out of 10. By 22Feb2021, she was wearing a splint, it was 8 out of 10, and she felt like she fractured it and it was swollen on the ulnar side. Regarding eye disorder, she is now under the care of an eye doctor for her severe double vision, eye crossing, and eye drooping. The blurred eyes give bad balance and that kind of stuff. The cross eyedness gives her poor peripheral vision and also her depth perception has now been compromised. They say the glasses will fix it. As of 22Feb2021, a new pair of special lenses with prisms were ordered for her. The patient was not hospitalized.
55 2021-03-31 anaphylactic reaction anaphylaxis approx. 25 minutes after injection - took 50mg benedryl and recovered within 90 minutes... Read more
anaphylaxis approx. 25 minutes after injection - took 50mg benedryl and recovered within 90 minutes of injection
55 2021-03-31 lymph node swelling I received my shot in right buttocks. After a week the lymph nodes in right groin area were signifi... Read more
I received my shot in right buttocks. After a week the lymph nodes in right groin area were significantly swollen.
55 2021-04-01 lymph node pain Day one after 1st dose: Woke up with joint and muscle pain, headache, chills, low grade fever (up t... Read more
Day one after 1st dose: Woke up with joint and muscle pain, headache, chills, low grade fever (up to 101.5F). Side effects increased in severity over the course of the day and into the night. Took one 500 mg Tylenol capsule in the afternoon against the headache. Day two after 1st dose: All side effects (above) were completely gone, but lymph nodes in the arm pits were very tender.
55 2021-04-04 swelling 3 episodes of abrupt and transient hypertension (max measured 218/113) with fever (38.1 C), marked h... Read more
3 episodes of abrupt and transient hypertension (max measured 218/113) with fever (38.1 C), marked headache and dyspnea on March 3, 4 and 7, requiring visits at Emergency Department (ED) on March 4 and 7. Episode on March 3 and 4 lasted few hours and self-resolved (2 liters iv saline on 3/4 at ED). Episode on March 7 required use of iv Atenolol at ED and oral Atenolol for the next 5 days. Starting March 5, flashes and floaters (?oily? spot in the right eye). All symptoms disappeared after March 12, except for the floaters in the right eye.
55 2021-04-04 lymph node swelling starting about 12 hours after the second Covid-19 vaccine injection in left arm: fever, body aches... Read more
starting about 12 hours after the second Covid-19 vaccine injection in left arm: fever, body aches, strong headache, general "flu like symptoms" about 24 hours afterr injection: cotinued fever, continued body aches, continued headache, red rash on arm at injection site, swollen lymph nodes on left side of body, unable to sleep 36 hours after injection: slight fever, continued body aches, continued red rash at injection site, continued swollen lymph nodes, unable to sleep comfortably
55 2021-04-05 lymph node swelling Had developed symptoms 24 hours afetr, extreme fatigue, chills, fever, unable to move legs this last... Read more
Had developed symptoms 24 hours afetr, extreme fatigue, chills, fever, unable to move legs this lasted 3 and a half days. 3/ 28 was in bed all day, arm pain and lymphnodes were swollen under arms.
55 2021-04-06 lymph node swelling Redness and swelling in the vaccine area. Arm pain and swollen glands
55 2021-04-06 peripheral swelling At 1045am, c/o tingling in lips and mouth. Gave Benadryl 25mg PO at 1048am and contacted Dr. Started... Read more
At 1045am, c/o tingling in lips and mouth. Gave Benadryl 25mg PO at 1048am and contacted Dr. Started shaking at 1050am. At 1100am, no tingling in lips. At 1110am, shaking stopped. At 1116, c/o tingling in throat and right hand swelling. EMS called to assess. At 1120am, monitored by EMS. At 1140am, left site feeling better. Instructed not to schedule second dose at drive through setting and to contact PCP for further recommendations. Instructed to take another Benadryl at home or go to ER for any further reactions. Also instructed to keep Epi-Pen at all times.
55 2021-04-07 anaphylactic reaction Patient experienced anaphylaxis with second dose of vaccine, epinephrine 0.3mg IM (as EpiPen) was ad... Read more
Patient experienced anaphylaxis with second dose of vaccine, epinephrine 0.3mg IM (as EpiPen) was administered, and patient went to hospital via ambulance.
55 2021-04-07 lymph node swelling Fever, chills, body aches, swollen glands under arms neck and head then a rash on front of legs th... Read more
Fever, chills, body aches, swollen glands under arms neck and head then a rash on front of legs that burned
55 2021-04-07 peripheral swelling large red bump on arm near vaccination, sensitive, swollen, sore to touch achy left arm and underarm
55 2021-04-08 peripheral swelling Sore arm, hip and calf left side. Lump under left arm. Fever, nausea, metallic taste, chills, wors... Read more
Sore arm, hip and calf left side. Lump under left arm. Fever, nausea, metallic taste, chills, worse than when I had covid
55 2021-04-08 peripheral swelling AT 10:45 AM PT C/O TINGLING IN LIPS AND MOUTH. GAVE PT BENADRYL 25MG PO AT 10:48 AM AND CONTACTED DR... Read more
AT 10:45 AM PT C/O TINGLING IN LIPS AND MOUTH. GAVE PT BENADRYL 25MG PO AT 10:48 AM AND CONTACTED DR. WAITED WITH PT EXTRA TIME. PT HAD STARTED SHAKING AT 10:50 AM. AT 11:00 AM LIPS NOT TINGLING. AT 11:10 AM, STOPPED SHAKING. AT 11:16 AM C/O TINGLING IN THROAT AND RIGHT HAND SWELLING. EMS CALLED TO ASSESS. AT 11:20AM PT BEING MONITORED BY EMS. AT 11:40 AM PT LEFT SITE, FEELING BETTER. PT TOLD NOT TO SCHEDULE 2ND DOSE AT ANY DRIVE THRU SETTING.
55 2021-04-08 swelling face 1.5 hrs after 1st dose of covid19 pfizer vaccine, pt developed pruritic rash on neck and upper back,... Read more
1.5 hrs after 1st dose of covid19 pfizer vaccine, pt developed pruritic rash on neck and upper back, swelling beneath eyes bilaterally and SOB noticed as increased use of rescue inhaler. States is "not having that hard a time of breathing".
55 2021-04-09 lymph node pain, lymph node swelling My lymph node at my left shoulder close to my neck is swollen, tender and hurts and I can feel the n... Read more
My lymph node at my left shoulder close to my neck is swollen, tender and hurts and I can feel the node moving.
55 2021-04-09 oral herpes 4-5-21 at 6:00 p.m.: stiff neck, fatigue 4-6-21 at 2:00 a.m.: Migraine, stiff neck, pain in right... Read more
4-5-21 at 6:00 p.m.: stiff neck, fatigue 4-6-21 at 2:00 a.m.: Migraine, stiff neck, pain in right cheekbone, leg cramps, pain in arm 4-6 thru 4-7: Fever, migraine, muscle cramps, throbbing pain in legs and hips, unable to lift left arm, fatigue, chills, nasuea, cold sores and mouth liasons (on pallate and bottom gum, left side, hoarse voice 4-7 thru 4-9: Only Hoarse voice, cold sores and mouth liasons 4-10: Only cold sores and mouth liasons remain
55 2021-04-09 swelling Hives, swelling, pain
55 2021-04-11 lymph node swelling Fever, High heart rate Friday and Saturday - typically 60 HR was >90 for 16 hrs Lymph node swelling
55 2021-04-11 swelling face, peripheral swelling The nurse said I had to stay for 30 minutes. At 15 minutes, they made us leave. My reaction happened... Read more
The nurse said I had to stay for 30 minutes. At 15 minutes, they made us leave. My reaction happened at 20 minutes while we were on our way home. I got sick to my stomach. Then my cheeks swelled up. I had some troubles breathing. The next day, my arm was swollen and painful, and I ached all over and was tired.
55 2021-04-11 swelling Patient reported allergic reaction after receiving 1st dose with associated facial rash, swelling an... Read more
Patient reported allergic reaction after receiving 1st dose with associated facial rash, swelling and pruritis. No SOB or difficulty swallowing. After discussing risks vs benefits, 2nd dose was not administered today.
55 2021-04-13 oral herpes Severe headache woke me up in the night after vaccine -resolved after putting ice pack on neck and h... Read more
Severe headache woke me up in the night after vaccine -resolved after putting ice pack on neck and head, night 2 woke again in the night with severe headache repeated ice pack felt better but I felt like something was wrong so made apt with my PCP that morning. BP was very high, was shaky and had low grade pain in back neck/ spine. BP slowly came down. Day 3 had 2 episodes of chest pain in am had an ekg later that day and it came out ok. No events detected. Going into week after vaccine (days 5-8) ongoing pain mid back/ spine and developed a cold sore ( had not had one in over a year) 4/12 woke with Head and neck pain but not as severe as first couple days. Still don?t feel ?quite right? but functioning ok.
55 2021-04-13 peripheral swelling stated that while she was getting her 2nd shot, that she called the HD to report swelling of her rig... Read more
stated that while she was getting her 2nd shot, that she called the HD to report swelling of her right hand and development of blisters. States that the employee told her that was not a side effect and told her to move her arm about to increase absorption. She mentioned that blisters formation and later popped with refness and pus drainaing from her left hand. MD was consulted who was concerned about a blood clot but doppler was negative. Today, remnants of that swelling persists but the redness has gone away. blister is dried and healing with no s/s of redness, drainage, however, top part of hand is swollen. Encouraged to elevate left arm to promote return to normal size of arm. Notified to call HD a
55 2021-04-13 swelling 55 yo F reported rash with 2-3 cm wheel that first appeared 2-4 hours after 1st dose of Pfizer COVID... Read more
55 yo F reported rash with 2-3 cm wheel that first appeared 2-4 hours after 1st dose of Pfizer COVID vaccine. Rash first appeared on L palm, then right palm, then L foot. Rash cleared in approximately 1 week. She endorsed mild pruritis without dyspnea, swelling, wheezing.
55 2021-04-14 lymph node swelling, swelling face 2days after my teeth! My teeth are in so much pain only on the left side and now I have swollen glan... Read more
2days after my teeth! My teeth are in so much pain only on the left side and now I have swollen glands in my neck left side! My face is getting puffy on the left side as well! I just want to know am I the only one!? I am now laying on a heating pad around that area! And taking tylenol because ibuprofen makes it worse! I would do this over again but want to know if it is normal and how long will it take for it to come out of my teeth!? Thank you!
55 2021-04-14 lymph node swelling 2 days of mild soreness at injection site; swollen lymph nodes under jaw/sore throat and fatigue for... Read more
2 days of mild soreness at injection site; swollen lymph nodes under jaw/sore throat and fatigue for 4 days after injection --everything was better after a week.
55 2021-04-14 lymph node swelling Mild chills one day after with some muscle aches. 2 days of alot of soreness at injection site; swol... Read more
Mild chills one day after with some muscle aches. 2 days of alot of soreness at injection site; swollen lymph nodes under jaw/sore throat and fatigue for 4 days after injection --everything was better after a week.
55 2021-04-14 peripheral swelling Client reports swelling in both hands after receiving the vaccine Fire Rescue evaluated patient. Pa... Read more
Client reports swelling in both hands after receiving the vaccine Fire Rescue evaluated patient. Patient had her own Benadryl and self administered 25 mg. orally. Swelling began to decrease and BP lowered as well. No presence of hives or SOB. Per Fire Rescue no further evaluation needed. Client released at 12:00pm.
55 2021-04-14 peripheral swelling Had a reaction 25 minutes after receiving the vaccine. swelling tongue, hands and feet. Dizzy, nause... Read more
Had a reaction 25 minutes after receiving the vaccine. swelling tongue, hands and feet. Dizzy, nausea, felt like I was going to throw up. Cold sweat. Lasted for about 25 minutes. Felt okay the next two days, then starting Friday 4/9 the dizzy and nausea came back. Tightness in chest and so dizzy having trouble working a full day at work. Some times it would go away and I would feel fine, then it would come back. I haven't had one day where I have felt good the whole day since.
55 2021-04-14 sepsis R06.03 - Respiratory distress J18.9 - Multifocal pneumonia K72.90 - Liver failure without hepatic co... Read more
R06.03 - Respiratory distress J18.9 - Multifocal pneumonia K72.90 - Liver failure without hepatic coma, unspecified chronicity (CMS/HCC) U07.1 - COVID-19 A41.9 - Sepsis, unspecified organism
55 2021-04-15 anaphylactic reaction Anaphylaxis - throat swelling
55 2021-04-15 lymph node swelling Swollen supraclavicular lymph nodes on left side
55 2021-04-15 lymph node swelling sore arm,fatigue,swollen lymph nodes and constant and on going headaches at least 3 to 4 times daily... Read more
sore arm,fatigue,swollen lymph nodes and constant and on going headaches at least 3 to 4 times daily.
55 2021-04-15 swelling Patient received dose of vaccine on 4/7/21. Patient noted area of blanchable redness on 4/16/21 abou... Read more
Patient received dose of vaccine on 4/7/21. Patient noted area of blanchable redness on 4/16/21 about 2 inches distal to the vaccine site. Area of redness is 3.5 cm x 4.5 cm. Slight swelling, tender to touch, and slight itching. No drainage, opening of the skin, or flaking. Unclear if related to vaccine, but given uncertain etiology and proximity to site of injection reporting as possible adverse reaction. Plan for patient is to currently monitor, and advise office with new or worsening symptoms.
55 2021-04-16 lymph node swelling Vaccine at 1115a. Hydrated after the vaccine a lot. Was fine most of the day and evening, except f... Read more
Vaccine at 1115a. Hydrated after the vaccine a lot. Was fine most of the day and evening, except for increasing soreness of arm at injection site. Woke up at 2a with headache, then sleepless most of the night. Sore arm. Headache and general feeling of nausea thru mid afternoon, 2p. Sensitive skin, occasional slight chills. Headache turned very severe mid afternoon. Fever of 101. Took 2 Excedrin around 530p, used ice pack on head and neck. Felt slightly better around 7p and was able to eat some food. Noticed swelling under my arms that evening, particularly left arm. Headache mostly gone by 930p. Slept 9 1/2 hours. Seem recovered, except for sore arm and continued lymph node swelling.
55 2021-04-18 lymph node pain At time of injection, a significant portion of the vaccine spurted out of my skin and ran down my ar... Read more
At time of injection, a significant portion of the vaccine spurted out of my skin and ran down my arm, the following morning there was a large lump under the injection site that was soft, movable and painful, also there was a slight rash around the injection site, after some squeezing and itching, the lump became hard and painful, the rash covered more area of the arm and the pain spread under the arm to the lymph nodes.
55 2021-04-19 lymph node swelling patient received shot on 9th has had about 10 days of diffuse pain, extreme fatigue, nausea and vomi... Read more
patient received shot on 9th has had about 10 days of diffuse pain, extreme fatigue, nausea and vomiting, diarrhea and diffuse lymphadenopathy on exam. Lines up pretty well with receiving the second dose as symptoms started within 24 hrs of second dose. She does have other medical co-morbidities but they had been improving of late. treated symptomatically for now monitoring and getting basic labs
55 2021-04-20 swelling, c-reactive protein increased Patient experienced self-limited angioedema of the lips resulting in perioral numbness that persiste... Read more
Patient experienced self-limited angioedema of the lips resulting in perioral numbness that persisted for 2 weeks before resolving. Errythematous papulovesicular rash on dorsum of both great toes. Thrombocytopenia with platelet count of 129,000.
55 2021-04-20 swelling This was my second dose. About 1 minute after vaccination Both sides of my mouth released saliva th... Read more
This was my second dose. About 1 minute after vaccination Both sides of my mouth released saliva that tasted like copper. My neck started swelling up like a bullfrog and I felt pressure on both sides of my throat and had difficulty swallowing. I was closely monitored in the clinic and treated with Pepcid and Zyrtec. The swelling receded. Within 10 minutes after medication and I went home. The coppery taste lingers.
55 2021-04-23 lymph node pain, lymph node swelling I noticed my lymph node - there was a lump/bump there. My whole left side was sore - around the clav... Read more
I noticed my lymph node - there was a lump/bump there. My whole left side was sore - around the clavicle left side.. I consulted the health practitioner at work and she told me to go to my practitioner. My practitioner sent me to get a sonogram and a CT. By then I got the second dose, 1/21/2021. In time they all went back to normal (shrunk). It took about a month after the second vaccine for everything to subside and get back to normal. No treatment.
55 2021-04-23 lymph node swelling TIREDNESS, HEADACHE (MIGRAINE),, MUSCLE PAIN, CHILLS - SEVERE, JOINT PAIN, NAUSEA, FEELING UNWELL, S... Read more
TIREDNESS, HEADACHE (MIGRAINE),, MUSCLE PAIN, CHILLS - SEVERE, JOINT PAIN, NAUSEA, FEELING UNWELL, SWOLLEN LYMPH NODES (LEFT ARM ONLY)
55 2021-04-23 peripheral swelling Salvage vaccine was given greater than 6 hours after reconstituted. The patient was contacted and wi... Read more
Salvage vaccine was given greater than 6 hours after reconstituted. The patient was contacted and will follow up with her doctor. Patient experienced sore arm and shoulder. She also experienced swelling of her hands
55 2021-04-24 anaphylactic reaction felt like precursor to an anaphylactic response; Rapid heart rate; metallic taste; throat pressure; ... Read more
felt like precursor to an anaphylactic response; Rapid heart rate; metallic taste; throat pressure; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 56-Year-old female (non-pregnant) patient received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot was not reported) via unspecified route of administration and administered in left arm on 07Apr2021 14:00 as single dose for COVID-19 immunization. The patient no medical history and known allergies includes shellfish allergy and penicillin allergy, Levaquin, doxycycline were reported. The patient concomitant medications within two weeks included as Linzess, Prilosec, miralax, vitamin D were reported. Patient was not on other vaccines within four weeks. Patient had no Covid prior to vaccination and not tested for covid post vaccination. On 07Apr202 14:00 PM, the patient experienced rapid heart rate and metallic taste and dry mouth and throat pressure- felt like precursor to an anaphylactic response. Symptom onset was immediate and was decreased in 8 hours but still present 24 hours later. No therapeutic measures were taken. The outcome of the events was recovering.
55 2021-04-24 anaphylactic reaction Anaphylactic reaction; Eyes swollen; This is a spontaneous report from a contactable Other Health Ca... Read more
Anaphylactic reaction; Eyes swollen; This is a spontaneous report from a contactable Other Health Care Professional (reporting on her-self). A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EP6955 and Expiry date was not re-ported), via an unspecified route of administration on 06Apr2021 13:35 as single dose for COVID-19 immunization. Medical history included diabetes mellitus, fibromyalgia, intervertebral disc de-generation, post-traumatic stress disorder, back disorder all from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported; gabapentin (GABAPENTIN) taken for fibromyalgia, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for fibromyalgia, post-traumatic stress disorder, start and stop date were not reported; naproxen (NAPROXEN) taken for back disorder, start and stop date were not reported. The patient previously 'Incurin' and 'Epitab' and experienced anaphylactic reaction. Historical vaccine includes first dose of bnt162b2 for covid-19 immunisation. It was reported that on 06Apr2021 at 13:35, patient had her second BNT162B2 vaccine. she ended up having an anaphylactic reaction was hospitalized and just got out today. She also want to say she have a history of having anaphylactic reaction from three different medication 'Incurin' and 'Epitab'. Patient stated that she had nothing wrong after the first one. Patient is a Nurse but not working right now. she was disabled (Further not clarified if consumer is physically disabled or financially) but she was a nurse. Patient was hospitalized on 06Apr2021. patient stated, she, was better. Her eyes are still swollen but she breathing when she went to hospital. Consumer stated for laboratory work Well in hospital they got lab, not before the vaccine and in the hospital they did lab when she got admitted in the hospital. Patient stated since she got in the hospital she have to take Prednisone for 5 days and Benadryl (treatment) for 5 days. she just got out of the hospital. The outcome of the event Anaphylactic reaction was recovering and for event eyes swollen was not recovered.; Sender's Comments: The events was considered related to suspect drug based on strong temporal association and known safety profile of the drug. however, the contribution of age and underlying medical conditions cannot be excluded.
55 2021-04-24 lymph node pain, peripheral swelling It is not comfortable. It goes under arm all the way under her boob and down her side. It is not com... Read more
It is not comfortable. It goes under arm all the way under her boob and down her side. It is not comfortable and cannot rest; It is not comfortable and cannot rest; Pain and Soreness in left shoulder; Muscle under right arm real sore like lymph nodes are sore/cannot lift her arm; Muscle under right arm real sore like lymph nodes are sore/cannot lift her arm; Muscle under right arm real sore like lymph nodes are sore/cannot lift her arm; Right arm swollen/arm was swelling/right arm is swollen underneath and on top; her arm was swelling and really hurting; has not been able to sleep in about 2 days because of this; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 55-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0150) intramuscularly in left arm on 01Apr2021 10:00 at single dose for COVID-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: diabetes diagnosed 3-4 years ago, blood pressure abnormal, and hiatal hernia. She has to take Prilosec for a hiatal hernia but has been taking it for years. Concomitant medications included omeprazole magnesium (PRILOSEC) for hiatal hernia, and blood pressure medication and diabetes medication. She previously received the first dose of BNT162B2 on 04Mar2021 (Lot EN6202) in right arm in the muscle for COVID-19 immunisation. She took the second one on Thursday and it was not bothering her until Friday night until Saturday morning. On 03Apr2021 05:00, it woke her up and it felt like it went in the muscle under her arm. It was real sore like lymph nodes are sore and she cannot lift her arm. She got the second shot on Thursday morning and that is what caused it. Sometime toward daybreak on Saturday morning is when she first felt that her arm was swelling and really hurting on 03Apr2021 05:00. Her right arm is swollen underneath and on top. On 04Apr2021 08:00, pain in left shoulder is like when old people say they have pleurisy in the back. She has not been able to sleep in about 2 days (Apr2021) because of this. No ER or physician's office required. She felt like going but did not took Ibuprofen. She thought it was going to be great because she did not have any symptoms, but this has whooped her. It is not comfortable. It goes under arm all the way under her boob and down her side. It is not comfortable and cannot rest. She read over the paperwork and saw that there were Lymph nodes and she wanted to know if there was anything she can do for it. She is just taking blood pressure medication and diabetes medication and has been on them for several years. Event outcome of not comfortable and cannot rest, insomnia was unknown, while for others was not recovered.
55 2021-04-24 lymph node swelling Symptoms: one day after- slight pain at injection location, some body ache. Two days after: swollen ... Read more
Symptoms: one day after- slight pain at injection location, some body ache. Two days after: swollen lymph node, left underarm.
55 2021-04-24 swelling face lips were swelling; swelling inside of cheek as well; heaviness in chest/felt like someone was stepp... Read more
lips were swelling; swelling inside of cheek as well; heaviness in chest/felt like someone was stepping on her chest; shortness of breath; really bad stomach ache; Inside of cheek felt rough; This is a spontaneous report from a contactable consumer (the patient). A 55-year-old female patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration (at the age of 55 years) on 22Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient reported that she was very sensitive to a lot of things, so she opted to stay for half an hour (after vaccination). Once she got in the car, she took her mask off, and realized her lips were swelling. She turned around and went back, and they let her sit for a little while longer. The swelling eventually stopped, but she did have swelling inside her cheek as well. It also felt like someone was stepping on her chest the rest of the day, she experienced shortness of breath, heaviness in chest, a really bad stomach ache, but didn't really eat much so didn't think that it was from food. Inside her cheek felt rough. The lip swelling went away without medication. The outcome of swelling inside her cheek, felt like someone was stepping on her chest, shortness of breath, heaviness in chest, a really bad stomach ache, cheek felt rough was unknown. No follow-up attempts are possible, information on lot number cannot be obtained.
55 2021-04-24 swelling face About 40 minutes after vaccination she developed diffuse hives and severe pain in the injected arm
55 2021-04-24 swelling a low grade fever; she is swollen under her armpit, which is very sore; she is swollen under her arm... Read more
a low grade fever; she is swollen under her armpit, which is very sore; she is swollen under her armpit, which is very sore; headache; body aches; tiredness; This is a spontaneous report from Pfizer sponsored program support. A contactable 55-year-old female consumer (patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration on 10Apr2021 as single dose for COVID-19 immunization. Patient had historical vaccine first dose of BNT162B2 (at 55-year-old) for COVID-19 immunization. The patient medical history was not reported. Patient concomitant medications included paracetamol (TYLENOL); ibuprofen, diphenhydramine citrate (IBU-PROFEN,DIPHENHYDRAMINE CITRATE). On 11Apr2021, the patient experienced headache, body aches, tiredness and on 13Apr2021, patient experienced a low grade fever, she is swollen under her armpit, which is very sore. Patient reports on Sunday, 24 hours after administration, she started experiencing a headache, body aches, and tiredness. She reports today, 3 days later, she has a low grade fever and she is swollen under her armpit, which is very sore. She called to ask how long she typically experience the side effects after her second dose of the vaccine given on Saturday afternoon, 10Apr2021. She was feeling a terrible headache, achiness, arm sore and feeling exhausted with low grade fever and she is taking Tylenol and Ibuprofen, she wanted to know how long she will take these medications. There was no PQC. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
55 2021-04-27 peripheral swelling tongue swelling, R arm swelling, b/l arm hives 13h after immunziation
55 2021-04-27 peripheral swelling After the second dose about 3 or 4 days later my face started feeling sunburned and then peeled off ... Read more
After the second dose about 3 or 4 days later my face started feeling sunburned and then peeled off starting in left hand corner near hairline of forehead and progressing through the rest of my face. I did not report this on the app at the time because I did not link it to the vaccination. This has happened 3 times since April 2, 2021. Starting April 12, 2021 I noticed my legs starting swelling during the day. On April 27, 2021 I noticed a rash on the inside of both legs right above the ankles. I have also been very sleepy and tired during the month with bouts of nauseousness. Since my blood pressure was high 141/85 (taken by my school nurse where I work) while on medication on 4/27/2021 and legs swollen, with rash she recommended calling the doctor. The doctor scheduled an appointment for 4/28/2021. The doctor said he feels the repetitive face burning/peeling with the swollen legs and rash is a delayed allergic reaction to the COVID vaccination along with Vasculitis. He gave me a Methylprednisolone Dose Pack of 4mg.
55 2021-04-27 swelling face 4 to 5 days after receiving vaccine, she noticed rash under left arm extending to deltoid area to el... Read more
4 to 5 days after receiving vaccine, she noticed rash under left arm extending to deltoid area to elbow, itchy red. Used cortisone cream to help with itch. next morning she noticed her left lip was swollen, numbness on left upper lip and swollen face. Only lasted for around 24 hours. Notified Dr and hasn't heard much from them. Was advised to speak with Dr in regards to it and getting approval for 2nd dose. She feels better today and never seeked care for this.
55 2021-04-28 anaphylactic reaction Chest Tightness , difficulty speaking , ANAPHYLAXIS
55 2021-04-29 lymph node swelling, swelling, swelling face After the 1st dose, I had sore arm and days later I had itchy rash around my right arm pit and my gl... Read more
After the 1st dose, I had sore arm and days later I had itchy rash around my right arm pit and my gland with swollen in the arm pit. After 2nd vaccine, sore arm and was tired for about 48 hours. Days later I'd noticed little itchy bumps on my left eye lid. On the night of 4/23, now both eye lids were itchy and a bit red. Throughout 4/24, eye lids got a little more swollen and still itchy and red, and by the evening my lips started to tinkle and a little bit swollen (it felt like I'm getting a cold sore) and I had noticed a few little bumps on the edge of my upper left side of lip (in a straight line). Throughout 4/25 my eye lids and lip were a little more swollen and feels like I'm having cold sore/sunburn. I
55 2021-04-29 lymph node swelling Very swollen lymph nodes under left arm. Started the following day and lasted 11 days.
55 2021-04-29 lymph node swelling Symptoms - Fever, body aches, swollen lymph nodes, nausea, headache, chills Treatment - Tylenol and... Read more
Symptoms - Fever, body aches, swollen lymph nodes, nausea, headache, chills Treatment - Tylenol and rest
55 2021-04-30 axillary mass In addition to common flu symptoms, I developed a painful large lump about the size of a lemon in my... Read more
In addition to common flu symptoms, I developed a painful large lump about the size of a lemon in my armpit. Also temporary vision improvement in both eyes.
55 2021-04-30 lymph node swelling felt tenderness; felt a nodule; Swollen lymph node; Tired; This is a spontaneous report from contact... Read more
felt tenderness; felt a nodule; Swollen lymph node; Tired; This is a spontaneous report from contactable consumer. A consumer (patient) reported for herself that the 55-year-old female patient received first dose of bnt162b2 (BNT162B2, Pfizer Covid-19), via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:40-10:45 (Batch/Lot Number: ER8727) as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced tired on 26Mar2021 13:00 with outcome of recovered, felt tenderness on an unspecified date with outcome of unknown, felt a nodule on an unspecified date with outcome of unknown, swollen lymph node on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of tired. The clinical course was reported as follows: She received her second dose at 1040 yesterday. Her first dose was fine, she was just tired. Today she was fine in the morning, she was is a little tired now, she seems to have a swollen lymph node like up on her neck, right above her clavicle. She noticed it was a side effect and is asking if it is temporary. She felt tenderness, felt a nodule. Caller asking will it go away in 48hours. Caller doesn't have a physician at this time. She got tired today at 1230. That was the primary symptom the first day after the first dose also. It was not so much that she couldn't function, she was just tired. Caller works remotely. She went and sat on the couch hoping to take a 15 minute cat nap. She laid down and thought why is her neck sore? She touched the area and felt the nodule. This was 1230-100pm this afternoon about 25-26 hours after the second shot. It's not worse or better. She was tired after the first vaccination on 25Mar2021 at 1040 or 1045. It started on 26Mar2021 about 24-28 hours after around 1300. It stopped on 27Mar2021, she awoke feeling fine, and recovered completely. Second dose LOT EW0158, left arm injection She is on no medications, she takes vitamin C and vitamin D in the mornings. She has no medical conditions. Caller tried here first and figured she would start here and if it was recommended to her to see a physician, she has one she has been referred to. No AE require a visit to Emergency Room or Physician Office. No relevant tests. No follow-up attempts are needed. No further information is expected.
55 2021-04-30 lymph node swelling new or worsened muscle pain; she has no memory of Sunday; pain that went up to her shoulder and acro... Read more
new or worsened muscle pain; she has no memory of Sunday; pain that went up to her shoulder and across her neck as the day went on; pain that went up to her shoulder and across her neck as the day went on; her legs and feet felt like they had cement blocks on them; tiredness in her arms; could barely walk; experiencing pain at the injection site in her left arm; injection site in her left arm with redness; She states that she felt like she was going to need to be hospitalized and just felt "out of it" and like she was "just existing; lymph nodes "the size of a plum pit"; chills; fever; sweating profusely; headache; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored program. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot# unknown), via an unspecified route of administration on 26Mar2021 (Friday) (at the age of 55-years-old) as single dose for COVID-19 immunisation. Medical history included asthma, diabetes. Patient contracted COVID-19 on 13Mar2020 and was ill for 3 weeks with no long-lasting effects. The patient concomitant medications were not reported. On 27Mar2021 (one day after vaccination, Saturday), patient experienced her legs and feet felt like they had cement blocks on them and could barely walk, tiredness in her arms, experiencing pain at the injection site in her left arm, injection site in her left arm with redness, felt like she was going to need to be hospitalized and just felt out of it and like she was just existing, lymph nodes (the size of a plum pit), chills, fever, sweating profusely, headache, pain that went up to her shoulder and across her neck as the day went on, and on 28Mar2021, she has no memory of sunday, and on unspecified date, new or worsened muscle pain. The patient had all these symptoms for half a day on Monday. Patient spoke to the CDC and the Board of Health but did not get any guidance. She also states she spoke to her doctor who thinks that because of her previous COVID-19 diagnosis, she has antibodies, and this was why her reaction was so severe. Patient wanted to know if there have been any reports of anyone else who has had these extreme symptoms after their first dose of the vaccine after having COVID-19 as well and she was definitely not going to get the second dose of the vaccine. The outcome of all the events was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
55 2021-05-02 fluid retention ( H/O bilateral mastectomies with reconstruction and right breast radiation in 2014.) New onset rig... Read more
( H/O bilateral mastectomies with reconstruction and right breast radiation in 2014.) New onset right breast discoloration, discomfort, and swelling that started three days after second dose of COVID vaccine. Vaccine was given in right arm. There are no s/s of bacterial infection, no fever, chills, or drainage.
55 2021-05-02 lymph node swelling, peripheral swelling Swelling of the injection site both times. After the second dose experiencing swelling of the arm, ... Read more
Swelling of the injection site both times. After the second dose experiencing swelling of the arm, tenderness, lymph nodes under the arm pit in the same arm of the injection.
55 2021-05-02 lymph node swelling Sore right arm with tenderness under the arm and pronounced blood vessels. on 5/1 and 5/2 started to... Read more
Sore right arm with tenderness under the arm and pronounced blood vessels. on 5/1 and 5/2 started to develop swollen lymph nodes. Will monitor and take tylenol/motrin- dual action form Q8H. Will report to the hospital with worsening symptoms such as change in vision, whole arm numbness, and or increasing size of lymp nodes under arm.
55 2021-05-03 peripheral swelling Swollen painful fingertips , and tinnitus.
55 2021-05-04 peripheral swelling, swelling face Face Swollen, Headache, Body aches, Muscles Spams, Arm Swollen
55 2021-05-04 peripheral swelling The next day my whole body was hurting for 3 days, then then I started getting swelling in my ankle ... Read more
The next day my whole body was hurting for 3 days, then then I started getting swelling in my ankle the left first then the right. the back bone of the foot turned really red, then my eyes are swollen up, my right eye turned blood red, my neck swelled and it's still swollen, I had swelling in my hands and two days ago my legs started swelling and the right is worse than then left. Yesterday and day before my groin had a lump and the doctor said it's my lymph node. I went to the ER and they said it was the lymph node, I'm getting worse instead of better. After the first injection I got a rash and a nodule came up and now I have a bunch of nodules, I also have Panniculitis Mesentery. I also have pictures of my eyes, my swollen feet, and ankles.
55 2021-05-04 swelling I got first shot on Friday April 9. On Monday the 12th, I got small rash on lower left arm, NOT at t... Read more
I got first shot on Friday April 9. On Monday the 12th, I got small rash on lower left arm, NOT at the injection site, but below it. By Tuesday the rash spread all over my body and got much worse. I was having short episodes of breathlessness and feeling a bit dizzy, and on the 15th I went to ER because the rash was getting worse and was creeping towards my face. The rash was red, kind of looked like a million mosquito bites, caused some swelling, and very itchy in the first few days. I was very uncomfortable and unable to sleep well. I tried Benadryl before I went to ER but it made me overly tired. At the ER the doctor diagnosed me with allergic reaction to the shot. He prescribed a course of Prednisone to calm the rash. I had a very active rash for OVER two weeks between April 12 to the week of April 26, and there is still remnants of the rash today, which I hope do not reactivate at any time. I could figure out the timeframe of most active rash better by looking at my notes and doctors but that is a general summary.
55 2021-05-05 sepsis cough, malaise, fatigue OTC medications sepsis
55 2021-05-05 swelling After almost 10 days after the injection my neck was in a lot of pain. I couldn?t turn it. Soon afte... Read more
After almost 10 days after the injection my neck was in a lot of pain. I couldn?t turn it. Soon afterwards, the whole left side of my neck swelled up including near the clavicle of my neck. My initial symptom after the vaccine was only a sore arm and headache.
55 2021-05-06 lymph node swelling, lymph node pain Swollen, painful lymph node under left arm. Same arm vaccine was administered
55 2021-05-06 lymph node swelling Patient started having unilateral shoulder pain 2 weeks following dose 1 of Pfizer injection, then p... Read more
Patient started having unilateral shoulder pain 2 weeks following dose 1 of Pfizer injection, then progressed to bilateral hip pain. Received 2nd dose and the following day had severe pain in arm, extensive lymphadenopathy. Pain in shoulders and hips increased, having difficulty with bending and ambulating, sciatic pain, cannot lift left arm at all at this time, difficulty sleeping due to pain and increased heartrate at night. Suspect development of autoimmune reaction post vaccination. Encapsulated shoulder requiring surgical intervention.
55 2021-05-07 lymph node swelling Shingles; bad back pain; felt like something was not right; checked my temperature and it was 102.1/... Read more
Shingles; bad back pain; felt like something was not right; checked my temperature and it was 102.1/fever broke; but I had body aches; My ear my neck my nose my mouth and underneath my chin the lymph node was swollen; Then I had these lesions / sores starting to appear on my face, my nose , my lips and in my mouth all on the left side; my mouth was horrible much difficulty eating and pain was pretty intense; my mouth was horrible much difficulty eating and pain was pretty intense; This is a spontaneous report from a contactable consumer. This patient reported for 2 patients. A 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 10:30 at the age of 55 years-old(Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included High Blood Pressure , Vertigo, Meniere"s Disease, Gallbladder removed, Cluster of Calcifications and Nodules removed in left breast (benign) , Plaque Psoriasis ( had it very bad on hands and feet) Methotrexate (7 tablets I take on Saturdays)Methotrexate ( 7 tablets i take on Saturdays), also lots of enviromental allergies I was tested few years ago, possibly Augmentin and Clindamycin The patient's concomitant medications were not reported. The patient reported that on 13Mar2021, I was awoken up with bad back pain and I felt like something was not right . I checked my temperature and it was 102.1 . The fever broke but I had body aches etc And the left side of my face wasn't feeling right . My ear my neck my nose my mouth and underneath my chin the lymph node was swollen. Then I had these lesions / sores starting to appear on my face, my nose , my lips and in my mouth all on the left side, my mouth was horrible much difficulty eating and pain was pretty intense. Immediately scheduled appointments with my medical doctor and my dermatologist. The dermatologist biopsy and came back as Shingles . He immediately put me anti viral drug and my medical doctor put me on amoxicillin, Acyclovir, Gabapentin. I was out of work for 4 weeks cause I work in a Supermarket ( Deli). The patient did not have COVID prior to vaccination nor tested positive after vaccination. The outcome of the events was recovered with sequelae. No follow-up attempts are needed. No further information is expected.
55 2021-05-07 peripheral swelling Redness and swelling of arm.
55 2021-05-07 swelling face, swelling 4/15/21 - right outer ear pain. 4/19/21 - saw Dr. on demand - prescribed Amox-Clav 875-125 mg 2X a d... Read more
4/15/21 - right outer ear pain. 4/19/21 - saw Dr. on demand - prescribed Amox-Clav 875-125 mg 2X a day. 4/20/21 - right facial swelling - went to urgent care. Dr. said to stay on prescription given to fight bacteria infection. 4/27/21 - saw Dr. - prescribe Azithromycin 250 mg 2 tablet a day and Ciproflox-dexamerh ear drop. Again - diagnose as bacteria ear infection. 4/29/21 -right face paralysis-extreme pain. 4/30/21 - went to urgent care - extreme pain - Dr. directed to go to Hospital Emergency Room for CT scan and blood work. Diagnosed from Hospital ER is 1. Otitis external of right ear. 2. Facial nerve palsy 3. Ramsay Hunt Syndrome - auricular. Prescription-Acyclovir 400MG tablet 5x per day for 7 days. Prednisone 50 mg daily for 7 days. Hydrocodine-acetaminophen 5-325 mg as needed. Ask to follow up with ENT specialist on paralysis. Appointment made for 05/10/21 afternoon. Pain and swelling persisted throughout ordeal.
55 2021-05-08 lymph node swelling Heart palpitations and arrhythmia lasted several days after both first and second dose. Second dose ... Read more
Heart palpitations and arrhythmia lasted several days after both first and second dose. Second dose produced racing heart rate and concerning palpitations and arrhythmias(flutters), supraclavicular swelling L side baseball sized. Hives broke out over the swelling and down the neck. NO issues with breathing so I took Benadryl, applied ice and hydrocortisone cream swelling went down significantly and hives disappeared by evening. 9 days post second injection swelling slight/moderate swelling L supraclavicular remains. Blood pressure spike was noted at Dr. appt. 158/89. I started taking my own blood pressure at home averaging 151/100 . BP has been gradually decreasing and palpitations and arrhythmias have ceased.
55 2021-05-10 anaphylactic reaction waited in store for the required 15 minutes. Got in car to drive home . Stopped at light about 1030 ... Read more
waited in store for the required 15 minutes. Got in car to drive home . Stopped at light about 1030 and heart raced to 160 and very dizzy. I am a nurse and brought with me the epipen, benadryl repetab kids 12.5mg and proair...just in case. I was wearing my fitbit and it read 160. I took 50 of benadryl and was able to get home safely, Still felt very dizzy and heart rate dropped to 110 within 15 minutes. Sat in chair with feet elevated above heart. Then at around 11 started with severe chills that lasted about an hour. Obviously the benadryl knocked me out for about two hour. When woke up from nap my Heart rate was back in 70s chills gone. injection site hurt for several days and had knot in left arm for a week. I have type AB blood and have a PA1 stress hormone verified by specialty labs by doctor when I was pregnant in 2004.
55 2021-05-10 swelling face inflammation of the jaw muscle; dizzy; nausea; right side of my face swollen; her lips tingle a litt... Read more
inflammation of the jaw muscle; dizzy; nausea; right side of my face swollen; her lips tingle a little bit; head felt heavy above her eyes; Paraesthesia oral; had a minor UTI; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EP7533), via an unspecified route of administration in right arm on 07Apr2021 at 12:20 as single dose for COVID-19 immunization. Medical history included carpal tunnel syndrome (from: Jan2021), ear trouble predating vaccination. Concomitant medications included atorvastatin calcium (LIPITOR) 10mg taken once daily by mouth for cholesterol (taking for two years), cholecalciferol 2000IU; take once daily by mouth for vitamin D low (taking for two or three years). There was no prior Vaccinations within 4 weeks. On 07Apr2021 (A few minutes later, about 20 minutes after the vaccination), she felt dizzy and nauseous. Later on she noticed when she looked in the mirror, the right side of her face looked swollen. Adds her lips tingle a little bit at the same time as she got the dizziness and nausea. She called her doctor since this was immediately and not 24 hours later. Now weeks have passed and the right side of her face is still swollen; she is still dizzy and the nausea comes and goes. Adds her head felt heavy above her eyes too when she first felt the dizziness and nausea. It was reported that she went to the emergency room about week ago. They did a CT scan, EKG and drew blood and they told her the CT looks good; everything was normal except she had a minor UTI, urinary tract infection, and she was treated with antibiotics. Then later she went to visit her doctor and she said it looks probably like migraines triggered by the vaccine, and mentioned a lot of other theories, she can not remember them all. Adds she never gets the flu shot and the last vaccination she had was 30 years ago. Her doctor had a lot of theories and told her not to take any medication and to give her body a chance to recover. Caller added she also went to the dentist who did x rays and said everything looked fine. Then yesterday she went to the ENT, Ear, Nose and Throat specialist doctor for the dizziness and her face. The ENT doctor did some tests and said it was not vertigo or migraine because migraine comes and goes but hers does not go away. Then the ENT said he thinks it is inflammation of the jaw muscle. Caller adds her ear does not feel good sometimes. The ENT doctor said if connected jaws are not the same that can cause dizziness. He told her to take Aleve but she has not started it yet. She read somewhere today that in Israel other people have reported muscle inflammation, like heart muscle, and she is asking has that happened before with other people. The ENT also mentions she may be tightening her your teeth at night but she doesn't think she does that. Caller clarifies she had problems with her ear when she was very young and very rarely her ear is not comfortable when she sleeps on her side. But she does not sleep on her side anymore because her arms get numb. Adds she has carpal tunnel in both arms starting in Jan2021, predating treatment with the vaccine. Stated she was doing bike exercising and it caused the carpal tunnel. With regard to the swelling in the right side of her face, she stated no one can see it but if you touch it you can tell it is swollen and her husband can tell it was not big swollen but sometimes it gets bigger. Her doctor told her not to get the second dose until all the side effects go away or we know more. Mentioned her left arm was swollen from the carpal tunnel and the sports medicine doctor told her to take Advil. She took two weeks of Advil and her hand was fine. But then three weeks passed and her hand did not feel good again and looked a little swollen so she took Advil again for three days but she interrupted it 48 hours before the vaccine. She has not taken anymore Advil since then and she has not started it back. She was told to take ten 200mg daily but she only took two at lunch, one in the middle and one at night and it worked. The week before the vaccination, she took only 3 a day for 3 days then stopped it 48 hours before the vaccination. Provides for the Ibuprofen she took UPC 096619088041; lot SEP2021; expiration date P116896. This was the product she referred to as Advil. Caller asks isn't it the same thing. Caller mentioned she thought maybe it was a bad batch, referring to her vaccination, and adds she contacted someone that she knew who had the vaccine at the same location two hours later and they did not have any trouble; did not feel anything at all. A clone report is created to document the daughter's experience. It was reported that Pfizer COVID 19 vaccine; treatment first dose 7Apr2021; provides lot number from vaccination card but does not see NDC or expiration date. No specific results were provided other than the UTI. Patient visited to emergency room and physician office visit. Patient was not admitted to hospital. Family history included the patient mother had moderna with no side effects, brother had both Pfizer doses with no side effects, one daughter had one dose of the Pfizer with nothing and the other daughter had both Pfizer doses and had fever but nothing major. A clone report is created to document the daughter's experience. This is report 1 of 2. Caller was provided with phone number, option 3, and hours of operation for COVID-19 Vaccine only, Monday through Friday 8a-8p Eastern Time and Saturday and Sunday 9a-3p Eastern Time; prior to transfer to hold line due to high call volume. The outcome of the events dizzy, nausea, right side of my face swollen, head felt heavy above her eyes was not recovered and outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected
55 2021-05-11 swelling face Extreme Dizziness immediately; Face Swelling; Rapid heartbeat; Joint Pain; This is a spontaneous rep... Read more
Extreme Dizziness immediately; Face Swelling; Rapid heartbeat; Joint Pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262) (age at vaccination was 55 Years and non-pregnant at the time of vaccination) via unspecified route of administration on 26Jan2021 14:00 in left arm as single dose for COVID-19 immunization. The patient's medical history included Sjogrens Syndrom and high Blood Pressure. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. Concomitant medication (list of any other medications the patient received within 2 weeks of vaccination) included Losartin 100mg, HCT 25mg. On 26Jan2021, the patient experienced extreme dizziness immediately, face swelling, rapid heartbeat, joint pain. It was unknown whether the patient received any treatment for the events. These events resulted in emergency room/department or urgent care. The outcome of the events was reported as not recovered. Follow-up attempts are completed. No further information was expected.
55 2021-05-12 peripheral swelling Patient called at 10:51am. She stated that she had questions about vaccine. Patient states she recei... Read more
Patient called at 10:51am. She stated that she had questions about vaccine. Patient states she received 2nd Covid19 vaccine on 03/26/2021. The next day, om 27th of March, she awoke with bumps and swelling on arms. Right side was worse than left arm. (The vaccine was administered in left arm). She denies having fever, shortness of breath, dizziness, chest pain, or any other distress symptoms. The bumps are irritating and causes her to scratch. Because of the scratching , her skin has holes where the bumps are. As of today , the bumps are still there but she noticed a spreading rash on breast, chest, and neck. Patient states the rash/hives on her breast , chest,and neck area are not the same as the bumps on her arms. Patient states that she does not have insurance and has not seen a physician in 2 years. Was refused a Gold Card because her lack of a permanent resident. She has PO Box listed as her resident. Encouraged/advised patient to seek medical attention to be assessed by a healthcare professional. (Suggested going to clinic ,will see walk-in patients without insurance).
55 2021-05-14 peripheral swelling 5 hours after injection: Headache, Neck Stiffness, Low Back Pain, & Very tired. An hour later my sy... Read more
5 hours after injection: Headache, Neck Stiffness, Low Back Pain, & Very tired. An hour later my symptoms increased: Fever of 101.6 which lasted for 3 hours. Chills, Shivering, Exhaustion. Nausea. After my fever broke, my Legs started Kicking involuntarily,. They kicked Constantly for 2 hours. (It was scary and out of the ordinary.) So much so that my knees hurt. If I forced my lag to stop kicking, my ankles and feet start jittering. If I get up to walk around my feet swell up. I was Still nauseous. I was unable to eat Lunch or Dinner. At bed time I was able to eat a bowl of cereal, and my legs finally stopped kicking. Nausea subsided. Next morning felt achy and had a runny nose. 34 hours after vaccination. felt tired, had chills and nausea again. I had to take a nap. The following day I felt like I was back to normal.
55 2021-05-14 swelling Headache; First day after vaccination as feeling the blood vessels on the front of her head expand a... Read more
Headache; First day after vaccination as feeling the blood vessels on the front of her head expand and feel swollen, and states that this feeling was also in the back of the head/ Feeling like deep vessels in front of her head; Dizzy/Dizziness; She felt dizzy, with light seeming to make it worse; Eyes were "swollen and red."; Eyes were "swollen and red."; She want to sleep on more often; This is a spontaneous report from a contactable consumer. This 55 year old female consumer (patient) reported for herself that: A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE;Solution for injection;), dose 1 via an unspecified route of administration on Apr2021 as SINGLE DOSE for covid-19 immunisation.Medical history included seasonal allergy from an unknown date and unknown if ongoing , seasonal allergy from an unknown date and unknown if ongoing Her daughter, who has not yet received the vaccine, has seasonal allergies to things like pollen and certain food allergies as well, such as allergies to shrimp and crab , seasonal allergy from an unknown date and unknown if ongoing Her daughter, who has not yet received the vaccine, has seasonal allergies to things like pollen and certain food allergies as well, such as allergies to shrimp and crab , food allergy from an unknown date and unknown if ongoing Her daughter, who has not yet received the vaccine, has seasonal allergies to things like pollen and certain food allergies as well, such as allergies to shrimp and crab. The patient's concomitant medications were not reported. The patient experienced headache , first day after vaccination as feeling the blood vessels on the front of her head expand and feel swollen, and states that this feeling was also in the back of the head/ feeling like deep vessels in front of her head , dizzy/dizziness, she felt dizzy, with light seeming to make it worse eyes were "swollen and red." , eyes were "swollen and red.", she want to sleep on more often on Apr2021 Caller states that her daughter, who has not yet received the vaccine, has seasonal allergies to things like pollen and certain food allergies as well, such as allergies to shrimp and crab. Caller would like to know if because of her daughter's allergies, which she state are "severer than mine", it would be for her to receive a dose of the Pfizer BioNTech COVID-19 vaccine.Response: Spoke from the attached document regarding contraindications to receiving a dose of the vaccine and sent list of ingredients to caller via email that her daughter could review with a HCP to help determine if there is anything in the vaccine she should be aware of based on her allergies.Caller is a 55 year old female who is calling on behalf of her 20 year old son who received his first dose of the Pfizer BioNTech COVID-19 vaccine this morning. Caller states that her son has autism and when he received his vaccination this morning, she was holding him and states that after the nurse injected the needle and then pulled it out, she saw "water" and fluid on the floor and then reports blood came out that took "4-5 cotton balls" to clean up. Caller is concerned now because she does not believe her son got the full dose of the vaccine and wants to know if there is a way to tell if he did get any of the first dose. Caller mentions the possibility of him getting an antibody test doneCaller also reports that she and her husband received their first doses of the Pfizer COVID-19 vaccine last week and states that her husband did not have any symptoms but she did. She reports having a headache that she describes on the first day after vaccination as feeling the blood vessels on the front of her head expand and feel swollen, and states that this feeling was also in the back of the head. She reports that the second day she felt dizzy, with light seeming to make it worse and reports it occurring during the day. She also reports that her eyes were "swollen and red." She states that now, one week later, it has gotten better, stating at one point that she still felt dizzy at times and then stating later that she no longer has any symptoms of dizziness. She reports that overall her reaction was "very minor" and is not sure if it is caused by the vaccine itself or could possibly be due to her seasonal allergies (she states that she read online that it is "probably allergies"). She also mentions that she had a friend who received the Pfizer COVID-19 vaccine and said her arm was sore after. She states that this friend told her that side effects were worse after the second dose of the vaccine. DSU: E-transmitting AE as caller declined warm transfer.Response: Let caller know that there is no information available to speak from regarding how to tell if her son got a full first dose of the vaccine. Spoke from the attached documents regarding how the first and second dose of the vaccine work and CDC's recommendations that antibody testing not be used as a form of testing to see if immunization occurred. Referred caller to HCP for further guidance. Let caller know that she could have her son's HCP call us himself/herself on her son's behalf to see if there is any further information that could be provided to a HCP specifically. Provided her with option #3 and also gave her this INT number to use as reference.Question: Caller states that her son has autism and when he received his first dose of the Pfizer BioNTech COVD-19 vaccine this morning, she was holding him and states that after the nurse injected the needle and then pulled it out, she saw "water" and fluid on the floor and then reports blood came out that took "4-5 cotton balls" to clean up. Caller is concerned now because she does not believe her son got the full dose of the vaccine and would like to know if it would be safe for him to get the second dose in this situation. She is concerned about any side effects that he may experience with the second dose if he did not truly receive a first dose of the vaccineResponse: Let caller know that there is no information available to speak from regarding the safety of getting the second dose after a possible invalid first dose. Spoke from the attached documents risks associated with getting any dose of the vaccine. Referred caller to HCP for further guidance. Let caller know that she could have her son's HCP call us himself/herself on her son's behalf to see if there is any further information that could be provided to a HCP specifically. Provided her with option #3 and also gave her this INT number to use as reference.Question: Caller would like to know if the Pfizer BioNTech COVID-19 vaccine works on the new variants. Response: Spoke from these two press releases regarding variants: Question: Caller states that she was told that if someone has an allergy to vaccines that are similar to the COVID-19 vaccines, such as flu or tetanus vaccines, it would still be ok to get the Pfizer BioNTech COVID-19 vaccine. Caller would like to know if this is true because she does not know what vaccines would be considered "similar" to the Pfizer BioNTech COVID-19 vaccine.Response: Spoke from the attached document regarding contraindications to receiving a dose of the vaccine and let caller know that because I am only trained to speak about the Pfizer COVID-19 vaccine, I could not safely say what other vaccines out there would be considered "similar." Referred caller to HCP for further guidance.Question: Caller states that she heard that the second dose of the Pfizer BioNTech COVID-19 vaccine is worse in terms of side effects and would like to know if this is true.Response: Spoke from the FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION PFIZER-BIONTECH COVID-19 VACCINE Prescribing Information Tables 1-4 (LAB-1457-7.0. Revised: 06 April 2021) to let caller know that overall there was a greater percentage of participants who reported side effects following the second dose versus the first dose in the clinical trial.Call was transferred .Transferring agent stated, "She already get the first dose. I am not sure what date actually she had it. After the first dose she felt headache, dizziness and she said that she kind of feeling like deep vessels in front of her head and she kind of feel she would like she want to sleep on more often."When paraphrased the concern, consumer stated, "I had a vaccine actually two weeks ago. So last week I week a lot of headache."In response to file safety report, consumer stated, "My question is this is normal reaction for vaccine Consumer was provided with the number of Pfizer Medical Information timings 8 am-8 pm Monday- Friday, 9 am-3 pm Saturday-Sunday as per EST.Consumer hung up the call abruptly.So further probing could not be done. Hence, Product details (LOT#, Expiration date, NDC#, UPC#) and other patient's details were unknown.Limited information was available over the call. outcome of the events was for Dizzy/Dizziness,She felt dizzy, with light seeming to make it worse was recovered outcome of Eyes were "swollen and red was recovering outcome of other events was unknown No follow-up attempts are needed; information about lot/batch number cannot be obtained.
55 2021-05-15 lymph node pain First day 37,7 max of fever, pain at injection site, tiredless and little headache. Second day injec... Read more
First day 37,7 max of fever, pain at injection site, tiredless and little headache. Second day injection site swelling and redness (round more than 10 cm of rush) and pain near lymph nodes under the same arm of vaccine injection site.
55 2021-05-18 lymph node pain, lymph node swelling Patient stated she felt a node that formed on the left side of her collar bone about 2 hours after s... Read more
Patient stated she felt a node that formed on the left side of her collar bone about 2 hours after she received the vaccine on 5/16/21. Patient received the vaccine in the left arm. Patient stated the pain and size progressively increased. Patient called the pharmacy on 5/18/21 stating the node was about a quarter size and very painful. Patient was advised to contact her primary care doctor for further evaluation and to take some ibuprofen/Tylenol for pain.
55 2021-05-19 lymph node pain, lymph node swelling With my first shot, my arm became sore 8-10 hours after the injection and stayed that way for about ... Read more
With my first shot, my arm became sore 8-10 hours after the injection and stayed that way for about 24 hours. With my second shot (also in the left arm), I had the same reaction as the first injection; however, about 3 days later I woke up with a large lump under my left armpit. Over the next few days, I had swelling on the left-side of my left breast, swelling under the breast and below the left collarbone. This has been very painful, especially at night when I lay down. During the day, it seems to drain (relieving some of the pressure). As of today, I am 6 weeks out, and I still have some swelling on the outer left of my left breast. The lump under my arm has disappeared and the swelling under my collarbone has gone as well. Now I am dealing with sore muscles in my neck and shoulder on my left-side. I believe this to be because I could not hold my arm in a normal position for a number of weeks. My doctor ordered physical therapy for this issue.
55 2021-05-19 sepsis Clinical Support, 5/4/2021, Family Medicine - LPN, Close exposure to COVID-19 virus, Dx, Covid-19 S... Read more
Clinical Support, 5/4/2021, Family Medicine - LPN, Close exposure to COVID-19 virus, Dx, Covid-19 Screening Reason for Visit. ED to Hosp-Admission Discharged 5/6/2021 - 5/8/2021 (2 days), Hospital, DO, Last attending, Treatment team COVID-19 virus infection, Principal problem, Medical Problems , Hospital Problems, POA, (Principal) COVID-19 virus infection- Yes, Hypokalemia- Yes, Diarrhea- Yes. Presenting Problem/History of Present Illness/Reason for Admission Hypoxia [R09.02] COVID-19 virus infection [U07.1] Severe sepsis Hospital Course, Pleasant 55-year-old female admitted to the hospital with signs of severe sepsis with associated acute hypoxic respiratory failure. Was found to be febrile, tachycardia, tachypneic, hypoxic on admission. Chest imaging did reveal patchy infiltrates consistent with viral pneumonia. Was diagnosed with COVID-19. Started on antiviral, corticosteroid, and received antibiotic therapies while in hospital. Improved significantly over the course of 2 days and was able to titrate back to room air. I recommended discharge home, she will continue to isolate until 14 days from initial diagnosis. Recommended the use of albuterol as needed, and she will continue a taper of prednisone. She will follow-up with PCP in 7 to 10 days
55 2021-05-20 c-reactive protein increased, white blood cell count increased Patient developed severe nausea and vertigo as well as generalized weakness, which started May 5. P... Read more
Patient developed severe nausea and vertigo as well as generalized weakness, which started May 5. Progressed to the point that she was unable to ambulate on her own at home and family called ambulance on 5/8/21 to take her to Health Care facilty. She received IV fluids, meclizine and ondansetron with gradual improvement. Still required walker and assistance by the time of discharge on May 13, 2021
55 2021-05-22 lymph node swelling fever body aches strong headache like something pressuring /squeezing my head inflammation of lymph... Read more
fever body aches strong headache like something pressuring /squeezing my head inflammation of lymph nodes in my neck area diahrrea on 2nd day
55 2021-05-22 lymph node swelling Left armpit swollen, hard and slight pain started 14 hours after shot. After another 24 hours, hard... Read more
Left armpit swollen, hard and slight pain started 14 hours after shot. After another 24 hours, hardness went away, just swollen.
55 2021-05-24 lymph node swelling On 04/15/2021 in the evening around 8pm I started feeling very tired and sleepy. My left side from t... Read more
On 04/15/2021 in the evening around 8pm I started feeling very tired and sleepy. My left side from the top of my head all the way to my left side of my leg felt numb and painful. My left side of throat felt numb, too. I felt dizzy and wanted to go to sleep.
55 2021-05-24 peripheral swelling About 2 hours after receiving the vaccine, patient reports having experienced swelling and pain of t... Read more
About 2 hours after receiving the vaccine, patient reports having experienced swelling and pain of the right wrist, left arm, and left hand, making use of her arms difficult. She also experienced a headache. The following morning 5/25, she woke up with these symptoms still occurring, only "worse" and states it is hard to/painful to hold the phone. Patient does not plan to seek medical attention at this point, she plans to wait and see if the swelling/pain/headache get better over the course of the day.
55 2021-05-25 swelling swelling of my lips and nose; sensation of having an allergic reaction; my lips are red and feel as ... Read more
swelling of my lips and nose; sensation of having an allergic reaction; my lips are red and feel as if they are burning; This is a spontaneous report from a contactable consumer (patient) A 55 year old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730) on 13Feb2021 at 12:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications included venlafaxine, levothyroxine sodium and cetirizine hydrochloride (ZYRTEC ALLERGY). The patient received first dose of BNT162B2 on 23Jan2021 on left arm. On 15Feb2021 at 09:30 the patient experienced had slight swelling of her lips and nose. She had the sensation of having an allergic reaction but can breath fine. The edge of her lips were red and feel as if they were burning as does the skin adjacent to the lips. Consumption of most foods makes it feel as if her lips are on fire (as reported). At the time of the reporting the patient had not yet recovered from reported events.
55 2021-05-26 lymph node pain Joint pain in shoulders, arms and hands. Side/rib pain, lymph nodes
55 2021-05-30 lymph node swelling, lymph node pain Lethargy approximately 12 hours after injection, lasting approximately 24 hours Swollen and tender l... Read more
Lethargy approximately 12 hours after injection, lasting approximately 24 hours Swollen and tender lymph node under right armpit approximately 48 hours after injection
55 2021-05-31 lymph node swelling Rash on left forearm; Chills; swollen lymph nodes; Sore right arm; This is a spontaneous report from... Read more
Rash on left forearm; Chills; swollen lymph nodes; Sore right arm; This is a spontaneous report from a contactable other hcp (patient herself). A 55-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Left arm on 29Jan2021 at 13:30 (at the age of 55-years-old) as a single dose for covid-19 immunisation. Medical history included first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown) administered in left arm on 08Jan2021 (at the age of 55-years-old) 13:30 for covid-19 immunisation, hypothyroidism, GERD, and unspecified allergies. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication received within 2 weeks of vaccination on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 30Jan2021 at 12: 00 AM, the patient experienced, Chills, swollen lymph nodes, Sore right arm, Rash on left forearm on day 4 and 5 post 2nd vaccine. No treatment was received for adverse event. The reporter assessed adverse events as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The outcome of the events was not recovered. Information on the lot/batch number has been requested. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
55 2021-05-31 peripheral swelling, c-reactive protein increased Chest pain, shortness of breath, joint myalgias, lower extremity swelling, low grade temp, cough, co... Read more
Chest pain, shortness of breath, joint myalgias, lower extremity swelling, low grade temp, cough, congestion started on 5/25/21. Admitted to hospital and given Xopenex treatments, tessalon Perles, IVFs,. Also had zofran, toradol, and acetaminophen as needed. Cough controlled with medication, myalgias to joints improved, afebrile, chest pressure improved by discharge on 5/28/2021
55 2021-05-31 swelling face Two days after shot my bottom lip started to swelling, this happened fur more times on random days ... Read more
Two days after shot my bottom lip started to swelling, this happened fur more times on random days each time getting worse and spreading on my face. Dr put me on steroid, pepcid and allergy pills for a week . Not getting swelling anymore but still have tingling in lip often ?
55 2021-06-02 swelling Onset of neck tightness, tingling, difficulty swallowing, reported angioedema of soft palate, nausea... Read more
Onset of neck tightness, tingling, difficulty swallowing, reported angioedema of soft palate, nausea. Sent to ER via wheelchair with ongoing sensation of choking and one episode of vomiting. Sensation of difficulty breathing. Administration of epipen upon arrival to ER. Following this, VSS and no further noted angioedema. Overall began to feel better. Additionally treated with solumedrol, benadryl and pepcid. No rash at any point. No labs drawn. Observed x 5 hours with no return of sx.
55 2021-06-06 lymph node swelling Next day I got rash, redness, and swollen lyph nodes on left arm, hot to touch and itchy on injecti... Read more
Next day I got rash, redness, and swollen lyph nodes on left arm, hot to touch and itchy on injection site. I also had aches and pains which little by little started to get worse and turned into spasms in my right side of my back, shoulder blade and elbows swollen and hurting. The my right started to hurt and continued elbow pain. To find out there is now inflamation in my blodd.
55 2021-06-06 sepsis Initial fever with neck, back and right thumb pain. Eventual diagnosis of sepsis. Four day hospital... Read more
Initial fever with neck, back and right thumb pain. Eventual diagnosis of sepsis. Four day hospital stay. Discharged home on Keflex antibiotic and meds for back pain. Four weeks later diagnosed with low EF of heart. Receiving meds to improve EF.
55 2021-06-07 guillain-barre syndrome This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant fe... Read more
This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6203, expiration date not provided), 2nd dose via an unspecified route of administration, administered in Arm Left on 05Mar2021 at age of 55 years old as a single dose for COVID-19 immunisation; mepivacaine hcl (manufacture unknown), via an unspecified route, date, dose for an unspecified indication. Medical history included Shingles. Concomitant medication included enalapril maleate (VASOTEC) taken for blood pressure. The patient previously took morphine and experienced allergies, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9265, expiration date not provided), 1st dose via an unspecified route of administration, administered in Arm Left on 11Feb2021 as a single dose for COVID-19 immunisation. The patient experienced guillane-barre syndrome, tingling and numbness in the legs, arms and lower face, severe headache, imbalance, disorientation, muscle spasms, diarrhea, all on 16May2021. The action taken in response to the events for mepivacaine hcl was unknown. The outcome of the events was not recovered. No treatment received for the events. The patient was not pregnancy at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Pfizer is a marketing authorization holder of [mepivacaine hcl] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [mepivacaine hcl] has submitted the same report to the regulatory authorities.
55 2021-06-07 swelling, peripheral swelling Swollen arm/arm had swollen up; Swollen arm, It was also warm and hot/it is warm, has heat to it; it... Read more
Swollen arm/arm had swollen up; Swollen arm, It was also warm and hot/it is warm, has heat to it; it is hot and warm; It was long, swelling is like the shape of a football/swelling is from the shoulder and started to go downward; This is a spontaneous report from a contactable consumer (Patient's husband). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN0186), via unspecified route of administration in the Left arm, on 18May2021 at 12:00 PM (at the age of 55-year-old), as a single for COVID-19 immunisation. Medical history and concomitant medications were not reported. There was no family medical history relevant to AE. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not received any additional Vaccines administered on same date of the Pfizer Suspect. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 27May2021, Yesterday around the afternoon her arm had swollen up, it is warm a little, has heat to it and it was long (clarified it was long as for the swelling is in shape of like a football). The swelling was from the shoulder and started to go downward. They tried to put an ice pack on it because it was hot and warm. They were wanting to know if there was anything to worry about and what are the side effects if she would experience and whether she need to pay attention especially, since it was been 9 days of vaccination. And whether the patient wanted to go hospital or it would be fine. The reporter also stated that he also wanted to take the shot but had worries on how safe it is for him to take it for himself. The adverse event does not resulted in Emergency Room or Physician Office. There was none relevant tests. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
55 2021-06-08 lymph node swelling fever; Pain at injection site; Headache; Runny nose; itchy eyes; Body aches; Swollen glands; This is... Read more
fever; Pain at injection site; Headache; Runny nose; itchy eyes; Body aches; Swollen glands; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 16:00 (at the age of 55-years-old) as single dose for COVID-19 immunization. The patient had no relevant medical history. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive other vaccines in 2 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 03Mar2021 at 07:00, the patient experienced pain at injection site, headache, runny nose and itchy eyes, body aches, swollen glands. On 07Mar2021 at 07:00, after day 6, the patient started running a 102 fever. Adverse events resulted in doctor or other healthcare professional office or clinic visit. Post vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Fever: 102 on 07Mar2021, Nasal swab test on 09Mar2021: Result pending. The clinical outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
55 2021-06-08 lymph node swelling rash started to spread on the right leg/ rash still spread to the whole body/full body rash; allergi... Read more
rash started to spread on the right leg/ rash still spread to the whole body/full body rash; allergic reaction to something; hives; Itching; random nerve pains; enlarged lymph nodes on both sides of the neck (Left lymph node is larger).; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 07Apr2021 at 14:30 (at the age of 55 years old; Lot Number: EW0151, unknown expiration) as 2nd dose, single for COVID-19 immunization. Medical history included ongoing reflux. Concomitant medication included pantoprazole for reflux since Dec2019. The patient also received her first dose of BNT162B2 on 17Mar2021 at 14:30 in left arm (at the age of 55 years old; lot number: EP6955) for COVID-19 immunization and experienced small rash on the lower left leg/little red rash on her left lower shin and the rash developed into some really bad itching. The patient received her second dose on 07Apr2021 and after some time, the rash started to spread on the right leg. She went to an urgent care and was told that she was having an allergic reaction to something. The rash still spread to the whole body. The doctor asked her if she had been hiking and she said she hasn't hiked in 20 years. She had no changes to the food she's eating, no laundry changes. The urgent care doctor prescribed prednisone and an antibiotic. The rash didn't get better. The rash turned into a full body rash and hives. She does not know the name of the antibiotic. Both bottles or containers of the prednisone and antibiotic have been thrown away. After she finished the prednisone and antibiotic, she went to her primary care doctor and the doctor agreed the rash looked like an allergic reaction. The patient also experienced itching. She was sent to a dermatologist and was prescribed second antibiotic and a steroid topical oil which somehow helped relieve the rash. The rash is clearing up now, she's finally not itching. This has been going on for two months. She also stated random nerve pains and enlarged lymph nodes on both sides of the neck (left lymph node is larger). The dermatologist did take a skin specimen or skin biopsy from her lower left leg and her right arm about 2-3 inches above her wrist on 18May2021 with unknown results. Those areas were deeper than a skin scraping, those areas had to be sutured. She does not have any results from the skin biopsy. She's guessing on the timing of when the rash first appeared on her left leg, she would guess about a week after receiving the first COVID-19 vaccine. At that time, it was only on her left leg. She still thought it was just a mosquito or spider bite, she didn't think it was related to the COVID-19 vaccine. The rash on her left leg was still present when she received her second COVID-19 vaccine. About 24 or 36 hours after she saw the dermatologist, she had improvement in her rash. The patient was also prescribed doxycycline 100mg capsules, take one capsule twice a day for 30 days. The steroid oil is fluocinolone acetonide topical oil 0.01%. Prior to her seeing the dermatologist the rash was spreading into a new area every day, it was almost full body, the rash was everywhere, every day there was more rash. Both doctors that she saw told her that the medication had nothing to do with her rash. She saw her primary care on 12May2021. She saw the dermatologist on 18May2021. Her primary care doctor wanted her to follow up with some blood work after seeing the dermatologist. She has not followed up with her primary care doctor yet. No vaccines administered on same date with the Pfizer vaccine. No prior vaccinations (within 4 weeks). The events resulted in physician office visit. The patient was recovering from rash and allergic reaction; recovered from itching on unspecified date; while unknown outcome for the remaining events. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
55 2021-06-09 peripheral swelling Heart palpitations, swelling in calves and ankles, headache, achy thighs, lethargic
55 2021-06-10 white blood cell count increased 55 y.o. female with a lifetime history of insulin-dependent diabetes that presented to the emergency... Read more
55 y.o. female with a lifetime history of insulin-dependent diabetes that presented to the emergency room just a few hours after she started having a left-sided neurologic deficit. The patient reports that she had a stroke several years ago but for some reason was told to not take aspirin and was not started on Plavix. Irregardless, the patient came in with a very significant left-sided neurologic deficit. She states that she could not speak, she had left facial droop, left arm weakness, and left leg weakness. She initially had an NIH stroke scale in the emergency room of 11. Initial CT of the head showed nothing acute. Consultation with neurology was obtained and the patient was sent for a CTA of the head and neck. No large vessel occlusion was identified and shortly after this the patient's NIH stroke scale reduced to 2 and shortly after this the neurologic deficit completely resolved and stroke scale return to 0. At that point, the patient was diagnosed with a TIA and admitted to the hospital for observation. This morning she states she feels fine. She has no neurologic deficit whatsoever. She denies any sensory or strength deficits this morning at all. The patient sugars have been a little bit high, but otherwise she had an uneventful evening
55 2021-06-13 lymph node swelling arm pain on the injection site and arm pit. enlarge lymph node, headache, fatigue, low grade fever, ... Read more
arm pain on the injection site and arm pit. enlarge lymph node, headache, fatigue, low grade fever, chill. These took about 10 days I took Tylenol and sleep a lot
55 2021-06-13 peripheral swelling Day 1 -5 (4/19- 4/23) - Sore L-Upper Arm, Mild Headache, Fatigue Day 6 -7 (4/24 - 4/25) - Mild Cons... Read more
Day 1 -5 (4/19- 4/23) - Sore L-Upper Arm, Mild Headache, Fatigue Day 6 -7 (4/24 - 4/25) - Mild Constipation Day 8-10 (4/26-4/28) - Mild Loose Stool 4/28 - 5/21 - Shortness of Breath, Dry Cough, Right side Pain, Swelling in Feet (more on Left Foot) 5/4 - Dr. visit 5/21 - Went to Emergency symptoms worsened
55 2021-06-15 peripheral swelling burning sensation /I had burning in my hands; Hives; Stinging; they're a little swollen; tingling al... Read more
burning sensation /I had burning in my hands; Hives; Stinging; they're a little swollen; tingling all over; I broke out in a rash at my neck; This is a spontaneous report from a contactable consumer who reported for herself, a 55-year-old female patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration, administered in left arm on 10Mar2021 at 12:30 (at the age of 55 years old) as first dose, single dose for COVID-19 immunization. Medical history included allergic to penicillin. Concomitant medication included ibuprofen (ADVIL). On 10Mar2021 at 16:30, the patient experienced hives, stinging, burning sensation within 4 hours of the injection. She further stated that 4 hours after administration of vaccine, she broke out in a rash at her neck and was tingling all over. She had burning in her hands and they're a little swollen. Urgent care put her on BENADRYL and prednisone twice and she doesn't know what to do because it's 'burny'. She was still feeling the tingling. The patient did not have COVID prior vaccination, and was not COVID tested post vaccination. The outcome of the events rash and swelling of hands was unknown, while the outcome of the remaining events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
55 2021-06-16 herpes virus infection Her blood pressure can be normal for two solid days and then have a reading of 170/110. Her blood pr... Read more
Her blood pressure can be normal for two solid days and then have a reading of 170/110. Her blood pressure was about that high when she got to ER on 10Apr2021, in spite of Propanol.; Her heart started flipping around in her chest; a little localized pain to her right arm where the injection was given; whole body was aching; Caller was so ill she barely ate or slept for three solid days.; Caller was so ill she barely ate or slept for three solid days.; After the vaccine, her joints ached to move. To move her elbow was 10x worse than normal. To get up and walk on her knee, to use that joint, was 10x harder and hurt 10x worse than usual; left knee and left elbow were inflamed; Very dehydrated; aching something terrible, like all of her joints; pain in her neck; Herpes outbreak; Really dizzy and felt weak; Really dizzy and felt weak; her mouth was extremely dry, had a weird metallic/chemical kind of taste; her mouth was extremely dry, had a weird metallic/chemical kind of taste; horrendous burning on the left side, just on the lower part of her rib cage and encompassed the whole top of her stomach; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 15:00 (Batch/Lot Number: EW0150) as single dose for COVID-19 immunisation. Medical history included 2 time breast cancer survivor: The latest cancer (second time) was in February of last year, she lost a quarter of her breast again to six 1mm atypical lobular hyperplasia tumors all together in her right breast. Operated on a year ago. They did follow up scan in Sep2020. She was cleared for one year. Osteoarthritis: Patient had several places in her back, but the MRI's shown osteoarthritis was more prominent in her neck. On 18Sep2019, she was injured in whiplash type car accident. Neurosurgeon did complete MRI on all three sections (cervical, thoracic, and lumbar) two weeks after accident. He just redid a second neck MRI and the osteoarthritis is worse, lots of bone spurs. She does have osteosclerosis/arthritis, mainly in her spine, but she also has Carpal tunnel and a bad knee. Degenerative disc disease was diagnosed long ago. Spinal stenosis was diagnosed long ago. She had a previous surgery, 18 years ago, a fusion at C5 and C6 in her neck. She had injured both her left knee and elbow in past from falling down/tripping because of her vision. Sprained Elbow over extended backward, messed-up joint. Fell on left knee: No surgery but did mess up the joint but were inflamed. Borderline diabetic/pre-diabetic started in 2016, she was trying to control with diet. The patient had a little acid reflux, a little chronic pain. She contracted herpes when she was 27 (in 1991). Concomitant medication(s) included propranolol (PROPRANOLOL) taken for blood pressure measurement from Jan2020 to an unspecified stop date; fluorouracil (FLUOROURACIL) taken for skin cancer, start and stop date were not reported. Propranolol: can take one in morning if not too late, sometimes have to wait until 1100 or 1200 and then as needed if later in day or evening have sudden rise can take second one or half of a tablet. Started taking Propranolol after noticing a drop in Potassium and other minerals/electrolytes. She went into kind of an a-fib event with very low potassium, determined have sinus tachycardia secondary to something else. Sometimes, her blood pressure is 100/72, so she can't touch it. She kind of has to use it throughout the day as needed. Her blood pressure goes up and down because of her sinus tachycardia. Her normal blood pressure was considered low normal. Fluorouracil: She was not doing full body treatment (she has done full body before and those are wicked). She was only spot treating a couple places on her face, left arm and right top of shoulder (not where the vaccine was given). In current spot treatment. Battling basil cells and squamous cells since age 32. Been taking about 23 years now and currently in treatment for a couple that tested positive for basil cell. The patient previously received flu shot in sept of 2017, first ever had other than vaccines for school as a child and she got so sick with the Flu in Feb2018 for 10 days, she about died. She never took the flu shot again. Other than that, she has never had any other vaccines unless as a child. The patient had no Prior Vaccinations (within 4 weeks). Family Medical History Relevant to AE(s) was none. The patient received their first dose Pfizer Covid Vaccine on 31Mar2021 and was due to have second shot. The patient had immediate side effects, as well as had some after getting home for at least a week or better. She had immediate reaction and was made to stay in the store for 30 minutes to monitor. The facility has it set up where you go across to another area just across from the Pharmacy once you received the vaccine, and there was a lady there that puts a 15 minute timer on chairs and makes you sit down. The lady just stood there and monitored everyone, making sure no one was having any problems. As soon as the caller sat down, the caller said to her girlfriend who was sitting in front of her, "oh my God, I don't feel right." The lady monitoring everyone asks the patient if she was feeling okay. The patient responded no, and that she was feeling really dizzy and felt weak. The lady pulled over another chair and made the patient put her legs up and she went and got the pharmacist. The pharmacist and additional pharmacist who gave vaccination to the patient also came over. The pharmacist instructed someone to go get a "pulse ox finger reader thing", which was placed on the patient's finger. The pharmacist asked if patient felt anything else which the patient was. As soon as the her feet were put up and the lady went to get the pharmacist, she noticed her mouth was extremely dry, just like a dessert, and she had a really weird taste in her mouth. She clarified it was like a metallic kind of taste, or a chemical kind of taste. She has never tasted anything like that- she was not sure what to compare it to other than it just wasn't right. The pharmacist monitored the pulse ox after it was placed on her finger. Her oxygen level was good at 98 and her heart rate was good in the 80's. The timer was turned to 30 minutes instead of the original 15. All of this took place within the first 5 minutes after the patient sat down. The pharmacist instructed the lady to keep a close eye on patient and to keep the pulse ox on her finger. She kept her feet up the entire time. She couldn't have anything to drink after, the Pharmacist said no, and said if she had any further issues, to call 911. She made it through that 30 minutes. She held onto her girlfriend's arm going out of the store because she felt like her legs were kind of weak and rubbery. She didn't seem to be as dizzy, but the caller still had a real dry mouth and weird taste. States her girlfriend who drove was her neighbor and the patient doesn't drive. When the patient was dropped off at her place, a couple hours later, the patient was being cautious and on guard. Drinking water seemed to alleviate the dryness some in her mouth and kind of got rid of that taste. But then, she noticed horrendous burning on the left side, just on the lower part of her rib cage and encompassed the whole top of her stomach-literally was between belly button and bottom of breast, just that center area of her trunk, from rib cage to rib cage. She explained the burning started on her left side and moved across like fire toward her other rib cage. The burning lasted probably about 5-10 minutes. She tried not to panic and asked herself if she had eaten. She received the vaccine at 1500 and she had eaten lunch. She hadn't been sick or anything from lunch. She doesn't have any stomach issues that would cause intense burning. Caller has a little acid reflux, but wasn't burping or anything. This was just like instant, "on fire" pain that went from left to the right, right through the middle of her trunk area. Then, the burning went away about 5-10 minutes later. She ate dinner and carried on with evening. She noticed the next day, 01Apr2021, maybe late morning (10:00 or 11:00, before lunch), she had the same burning feeling again in the same spot. The left bottom part of her rib cage had real intense burning that went across her mid section from left to right, in between belly button and bottom of breast. Again, the burning lasted about the same, 10-15 minutes. It burnt so bad caller didn't eat lunch. She also noticed when getting up that next morning, 01Apr2021, she was aching something terrible, like all of her joints. She had a little localized pain to her right arm where the injection was given. However, she had no rashes or swelling. She was breathing okay- she was keeping an eye out on that, especially since having immediate reaction. The burning feeling in her stomach area, ribcage to rib cage, was off and on for about 3 or 4 days. She felt like she was dying because her whole body was aching. Her joints were hurting when she got up or down, sat up or got down, get up to walk. She does have osteosclerosis/arthritis, mainly in her spine, but she also has Carpal tunnel and a bad knee. She clarifies anywhere she had previous injuries kind of got inflamed to the max. It was hard to sleep. She clarifies her neck was inflamed. She had a previous surgery, a fusion at C5 and C6 in her neck. Her last MRI 2 years ago showed osteoarthritis. The pain in her neck began the following day, 01Apr2021 and is ongoing. She is going to get a nerve block because it is so bad. States the pain is persisting, definitely hasn't improved even with rest. She clarifies after the vaccine, everything was hurting 10x worse. Also, her left knee and left elbow were inflamed- she had injured both her left knee and elbow in past from falling down/tripping because of her vision. After the vaccine, her joints ached to move. To move her elbow was 10x worse than normal. To get up and walk on her knee, to use that joint, was 10x harder and hurt 10x worse than usual. She noticed the pain/aching the following day, 01Apr2021 upon getting up and down. If she leaned over to look at her phone with her head down, it was like "wow what's going on with my neck". She is used to having a little chronic pain, but not like that. If she could get by with two Tramadol a day, she isn't hurting that bad. She has never been on anything stronger than Tramadol 50mg or Tylenol #3 for her neck, even after surgery 18 years ago. She goes back in forth between Tramadol 50mg or Tylenol #3. If she could go that long without going to a pain clinic and or being on a higher dose/stronger, this was not a good ride. She took two Tylenol Extra Strength in the middle of the day and also taking her prescription, Tramadol one 50mg, twice a day (in the morning and at night), and she could not get this pain under control for 3-4 solid days. She doesn't normally hurt like that. She didn't want to take more Tramadol (she is only prescribed it twice daily) so she took two Tylenol mid-day to get through the pain. She was on Propranolol, has sinus tachycardia and she can't take Ibuprofen or any other the counter (OTC) anti-inflammatory drugs. She has to get it by prescription and she only gets when she needs it which isn't very often. Generally, the Tramadol keeps the pain enough where caller can function. Receiving the COVID-19 vaccine, must have caused major inflammatory issues that she usually doesn't deal with. She doesn't lift things- she is 55 and hurt. She doesn't get out and do jumping jacks. The vaccine laid her up. She felt like she was dying- that's how sick she for about 4 or 5 days. She couldn't sleep, couldn't eat, couldn't move, she couldn't function. Every time she moved, it hurt. If she rolled over in sleep or got up, it hurt meaning her neck, her elbow, left knee and wrist hurt. She states she has carpel tunnel and doesn't like to have surgeries unless she has to. She was just aching all over. She was too sick to eat and too sick to sleep. She was so ill she barely ate or slept for three solid days. She got very dehydrated. She had to go to the hospital to get rehydrated, that's how bad it was. She clarifies she went to the emergency room and they checked her blood work and all. They rehydrated her and sent patient home. The patient left a message for her doctor, and the doctor called her and advised the caller to get Gatorade zero- she has to watch her sugar because she is pre-diabetic. She started bouncing back. About the 5th day, she started to sleep once she got rehydrated and past the worst of the pain/inflammation in her joints. Then, she went into a herpes outbreak which she had not had in probably 5 years. She had to deal with this for another 10 days. The herpes outbreak began maybe about 3rd or 4th day after receiving the vaccine. She started feeling like she was going get a blister and did. She didn't take any antiviral drugs, she never has, she always just let her body fight it. The outbreak has been gone for a few days. The dry mouth and weird metallic/chemical taste tended to subside later that day on 31Mar2021, after she drank some coffee and lots of water as she was trying to wash it down. That symptom did subsided the following morning, 01Apr2021. She believes this has resolved completely. Every now and then, a couple days following, she may have had an odd taste but she kept eating and drinking and it finally went away. Just following this event, she had one of those swallowing tests where they went down her mouth with a tube, and she was having trouble swallowing at the same time. She states when she gets sick like this and is experiencing untreated pain, it's hard for her to sleep and eat, and that's how she got so dehydrated. Finally by 10Apr2021, she was so dehydrated her doctor sent her to the emergency room. Following feeling dizzy and weak right after the vaccination, she had a couple dizzy bouts. However, this could have just been her dehydration or her blood pressure coming and going/low blood pressure events. They say she has sinus tachycardia secondary to something else going on, but they don't know what it is. So, she can't always get up and take Propranolol. Sometimes, her blood pressure is 100/72, so she can't touch it. She kind of has to use it throughout the day as needed. Her blood pressure goes up and down because of her sinus tachycardia. Her normal blood pressure is considered low normal. She had a couple of little off balance/dizzy spells but she laid down and then it subsided. She took her blood pressure and it was low when these spells happened. Her blood pressure can be normal for two solid days and then have a reading of 170/110. Her blood pressure was about that high when she got to ER on 10Apr2021, in spite of Propanol. She went to the ER and she called her doctor and did a phone visit prior to going to emergency room. She went to the ER on 10Apr2021. The doctor did a phone visit with patient on 08Apr2021. That's when the doctor told her to go get Gatorade zero. The patient also sent neighbor after the carnation instant breakfast mix and milk to get something in stomach and tried to get herself rehydrated. By 10Apr2021, patient was too far gone, she had been really sick and was too dehydrated. Her heart started flipping around in her chest, and because she is prone to having low potassium (she couldn't check at home), she called into the office and the doctor told her to go into the ER in which she did on 10Apr2021. She explained her blood work came back okay while in the ER. She was given two bags of fluid and released her as being dehydrate and they rehydrated her. The patient stated that, just that it was really bad experience and obviously something about her body didn't like the vaccine, whatever it was. She would like to follow up but she was going to talk to doctor on 06May2021, did report to doctor about the burning in her stomach. She has never felt anything like that ever. It was really in left of her side, kind of tucked where patient's in lower rib cage area. The patient doesn't feel too comfortable about the second shot especially with inadequate pain. She was scared to death to go through this again (with the second dose). The patient was due to see the doctor and wanted to wait and reschedule second dose Pfizer Covid Vaccine, if the doctor thinks she should get the second dose after she speaks with doctor. Outcome of event had a weird metallic/chemical kind of taste was recovered in Apr2021; aching something terrible, like all of her joints, pain in her neck was not recovered and all other events was unknown. No follow-up attempts are needed. No further information is expected.
55 2021-06-16 oral herpes Cold sore on my lips; This is a spontaneous report received from contactable Nurse (Patient). A 55-y... Read more
Cold sore on my lips; This is a spontaneous report received from contactable Nurse (Patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient's past medical history and concomitant medication was not reported. It was reported that 5 days after the administration of vaccine, the patient experienced cold sore on her lips on 17Mar2021. The patient was treated with Abreva cream on the area. It was stated that she just don't know if that was the reaction to it and don't know why she developed a cold sore which she never ever had and just want to know if it was safe to get the second shot. The patient did not receive any other products. The outcome of event was recovering. No follow-up attempts are possible. No further information is expected.
55 2021-06-16 oral herpes Cold sore; this breakout was bad; This is a spontaneous report received from a contactable consumer.... Read more
Cold sore; this breakout was bad; This is a spontaneous report received from a contactable consumer. A 55-Year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration, in arm left, on 25Mar2021 at 09:30 AM (at the age of 55 years, non-pregnant), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. There was no history of allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Mar2021, the patient had experienced Cold sore (I am so curious if you have ever heard this, have not had one in years and this breakout was bad). The treatment received for the adverse event was reported as anti-viral. Outcome of the event was reported as recovering/resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
55 2021-06-16 swelling, peripheral swelling and a pain and swelling on her left foot; and a pain and swelling on her left foot; She also felt wa... Read more
and a pain and swelling on her left foot; and a pain and swelling on her left foot; She also felt warm.; joint pain; swelling that radiated from her arch; the mark was still there on 18May2021 but the area is wider but lighter; exhibiting slight pain on scale of 1 to 4 time to time; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: FW0168) via an unspecified route of administration, administered in Arm Right on 18May2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Medical history included diabetic. There were no concomitant medications. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EW0172) on 26Apr2021 for covid-19 immunization and experienced dark marking over arch on side of foot. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. As after first dose she reported having a darkening and dark marking on her arch on the side of her left foot and after 2nd dose the mark was still there on 18May2021 but the area was wider but lighter and a pain and swelling on her left foot, with the pain level of 4 out of 10. She also felt warm. She also mentioned being diabetic and never having a problem on her feet before. Her HCP said that she would be undergoing tests. She also reiterated that joint pain was not same as foot pain and that her side effect should not be reported under joint pain. Reporter wanted to ask if these side effects have been reported yet. Reporter stated she got the second shot on 18May2021 and the mark was still there but maybe a week in a half after that she started exhibiting slight pain on scale of 1 to 4 time to time, swelling that radiated from her arch and it felt warm. Reporter also reported that, she went to see a podiatrist and she was prescribing a venous doppler to check it out. she wanted to notate this and how she had no issues with her feet previously. Patient stated felt warm started a week in a half after 18May2021. All events occurred in an unknown date in May2021. Patient visited to clinic. Patient stated she has taken Ibuprofen as treatment for felt warm, but she did not want to take it every day. The outcome of the events She also felt warm, swelling that radiated from her arch and exhibiting slight pain on scale of 1 to 4 time to time was not recovered and for other events was unknown Follow up needed, further information was requested.
55 2021-06-18 lymph node pain Hallucinations; Arm pain; Joint/lymph pain; joint/lymph pain; Splotchy red spots and itching; Splotc... Read more
Hallucinations; Arm pain; Joint/lymph pain; joint/lymph pain; Splotchy red spots and itching; Splotchy red spots and itching; Felt like my arms and legs were not connected, a disconnected feeling to reality, like the world was moving around me, trees were closing in; Extreme fatigue; Could not hardly move; Slept for 2 days straight; Loss of appetite; Digestive issues; Feel a little out of sorts; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female (not pregnant) received second dose of BNT162B2 (lot number - EW0182) on Arm left on 20May2021 (at age of 55-year-old) 10:30 AM at single dose for Covid-19 immunisation. Medical history included Hypersensitive to meds, peanuts bother her, Splenic Hemangiomas, Hypoglycemia. Concomitant medications included paracetamol (TYLENOL) and origanum minutiflorum oil (OREGANO OIL). Historical vaccine included first dose of BNT162B2 (lot number -EW0170) on Arm Right on 29Apr2021 (55-year-old) 01:15 PM for Covid-19 immunisation and experienced some brain fog, arm pain, horrible joint/lymph gland pain, feeling of small needles poking me in the head, a disconnect with her arms and legs and fatigue. This lasted about 4 days. Facility where the most recent COVID-19 vaccine was administered:Doctor's office/urgent care. No other vaccines within 4 weeks prior to the COVID vaccine. The second vaccine had arm pain, joint/lymph pain, splotchy red spots and itching, felt like her arms and legs were not connected, a disconnected feeling to reality, like the world was moving around me, trees were closing in, and hallucinations. That last for 5 days. Then there was extreme fatigue... could not hardly move and slept for 2 days straight. At this point, I had a loss of appetite and digestive issues. Events onset date was 20May2021. All in all it last almost 2 weeks. Still feel a little out of sorts but feeling better. The outcome of the events was recovering. No treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
55 2021-06-21 lymph node swelling Chills - experienced different times for approximately 1 month Severe Fatigue - lasted approximately... Read more
Chills - experienced different times for approximately 1 month Severe Fatigue - lasted approximately 1 month Headache - lasted approximately 1 month Muscle pain - lasted approximately 1 - 2 months Swollen lymph nodes - ongoing with slight pain with tenderness Frozen Shoulder - ongoing - under doctor's care (physical therapy - 6 - 8 weeks); issue not resolved.
55 2021-06-22 guillain-barre syndrome Numbness and weakness Left Leg; Numbness and weakness Left Leg; diagnosis Guillain Barre; This is a ... Read more
Numbness and weakness Left Leg; Numbness and weakness Left Leg; diagnosis Guillain Barre; This is a spontaneous report from a contactable consumer (patient). A non-pregnancy 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 24Mar2021 at 13:15 (at age of 55 years old, no pregnancy, Lot Number: EP6955) as a single dose for covid-19 immunization. No medical history and concomitant medications. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. On 21May2021, the patient experienced numbness and weakness left leg. On 29May2021 Emergency room misdiagnosed Sciatica couldn't bear weight used wheelchair. Went to primary 02Jun2021, followed by Neurologist diagnosis Guillain Barre. Confirmed by spinal tap at hospital after ER visit and 5 day stay at hospital with immunoglobulin treatments. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Since the vaccination, the patient was not had been tested for COVID-19. The outcome of the events was not recovered.
55 2021-06-24 lymph node swelling Swollen lymph nodes Right side of body neck, underarm and groin areas; Fever; Headache; Diarrhea; Th... Read more
Swollen lymph nodes Right side of body neck, underarm and groin areas; Fever; Headache; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 07Apr2021 at 1545, as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, melanoma and squamous cell skin cancers and small intestines bacterial overgrowth and also had drug allergy to erythromycin antibiotic. The patient did not take any concomitant medications within two weeks of vaccination. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 at 1730, as a single dose for COVID-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19 and also did not receive any other vaccine within four weeks of vaccination. Since the vaccination, patient not tested positive for COVID-19. On 04Apr2021 at 0300, the patient experienced Swollen lymph nodes on the right side of body at neck, underarm and groin areas and also had fever, headache and diarrhea. Therapeutic measures were not taken. The clinical outcome of all events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
55 2021-06-24 swollen extremities After 1st Dose:Fatigue lasting for several weeks. Occasional A-Fib episodes lasting less than 60 sec... Read more
After 1st Dose:Fatigue lasting for several weeks. Occasional A-Fib episodes lasting less than 60 seconds. On 5/17/2021 I experienced an A-Fib episode lasting 40 minutes and was seen at the ER and was treated for dehydration, and severe Electrolyte deficiency : Potassium, Calcium and Magnesium. Began to experience edema of lower legs which resolves 80 % after bedrest and returns the following day with activity. After 2nd dose: ( 5/20/2021) experienced Extreme Fatigue, Headache, Joint Pain, Muscle pain immediately following vaccine. Extreme Fatigue, Muscle Pain in Shoulders, Neck, Calves and almost daily mild A-Fib episodes continue up to and including today.
55 2021-06-28 lymph node pain, lymph node swelling Enlarged, painful, right under arm lymphnode. Started about 7-10 days after shot given. Lasted 7-8... Read more
Enlarged, painful, right under arm lymphnode. Started about 7-10 days after shot given. Lasted 7-8 days.
55 2021-06-28 peripheral swelling 01/08/2021 About 2:30AM in the morning, I was awoken with leg pan and took ibuprofen, went back to b... Read more
01/08/2021 About 2:30AM in the morning, I was awoken with leg pan and took ibuprofen, went back to bed, next morning got up for shower, right leg was swollen and discolored. Husband took me to ER, and they did n ultrasound and then a CT scan and a covid test, they found multiple clots up and down my leg, also found an opaque infiltrate on upper left lung , multifocal PE with a larger PE on right side. I did have possible exposure to covid 19 on 12/21/2021 and my profession is an operating nurse.
55 2021-06-29 lymph node swelling About 15 seconds after the vaccine my arm and my hand started to go numb. Later that night i starte... Read more
About 15 seconds after the vaccine my arm and my hand started to go numb. Later that night i started to have a throbbing pain around the injection site. On the 22nd I still had pain in the injection area. I put hot and cold compresses on it. On the morning of the 23rd I woke up with a migraine headache and a low grade fever. I was also extremely hot. I also was very tender and sore in the arm. I took 2 Excedrin migraine medications. The hot sensation did not go away. It was so bad that even a fan did not help. My doctor stated that I had lymph nodes that were swollen and inflamed. The Excedrin took away the migraine but not the feeling of being hot. On the 21st, I also felt very lethargic after the vaccine. I stayed out of work on the 22nd. I was sent home on the 23rd from work due to the symptoms I was having. I also had swelling under my arm as well. This past Sunday was the first day that I was able to do my normal activities.
55 2021-06-29 lymph node swelling This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non pregnant fe... Read more
This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration on 17Mar2021, at 12:30 on left hand, as a single dose (at the age of 55 years) for COVID-19 immunisation. The patient medical history included asthma, hypertension, and high cholesterol. The patient was not allergic to medications, food, or other products. Concomitant medication included Irbersartan/ HCTZ (MANUFACTURER UNKNOWN) 150-12.5 mg and atorvastatin (MANUFACTURER UNKNOWN) strength 200 mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021, the patient experienced very sore arm the night of the injection and on 18Mar2021, the patient experienced headache, severe body ache and swollen lymph nodes which caused a lot of pain in my armpit until three days after injection. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of painful arm, headache, general body pains and swelling of lymph nodes was recovered. No follow-up attempts are possible. No further information is expected.
55 2021-06-29 swollen extremities Leg/feet swelling (edema); Aches; Wheezing; Difficulty catching my breath (like the patient had bron... Read more
Leg/feet swelling (edema); Aches; Wheezing; Difficulty catching my breath (like the patient had bronchitis); Headache; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in left arm on 16Mar2021 at 14:15 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history included diabetic, blood pressure, cholesterol, neuropathy and depression. The patient had allergic reaction to original MMR vaccine in 1965. Concomitant medications included insulin (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), LYRICA and ZOLOFT for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 17Mar2021 at 12:00, the patient had leg/feet swelling (edema), headache, aches, wheezing and difficulty catching breath (like she had bronchitis). The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of leg edema, headache, aches, wheezing and difficulty breathing was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
55 2021-06-29 oral herpes Cold sore (mouth); This is a spontaneous report received from a contactable consumer, the patient. A... Read more
Cold sore (mouth); This is a spontaneous report received from a contactable consumer, the patient. A 55-years-old, female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 15Mar2021 at 14:45 as a single dose for COVID-19 immunisation. The patients medical history included sore mouth. The patient mentioned that she had experienced cold sores infrequently for the past 40 years. It was reported that patient had no allergies to medications, food or other products. The concomitant medication included Nexium for unknown indication. The patient received it within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 22Feb2021 at 14:45 as a first dose for COVID-19 immunisation. It was reported that, prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced cold sore mouth on 18Mar2021 at 22:00 (3 days after receiving vaccine). No treatment was received as a result of the event. The clinical outcome of cold sore mouth was not resolved. Information about lot/batch number cannot be obtained. No further information is expected
55 2021-06-29 sepsis Patient presented to the ED and was subsequently hospitalized for sepsis with acute organ dysfunctio... Read more
Patient presented to the ED and was subsequently hospitalized for sepsis with acute organ dysfunction.
55 2021-06-30 guillain-barre syndrome Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face; Gillian Varre Syndrome -... Read more
Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face; Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face; Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face; Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received 2nd dose of BNT162B2 Covid-19 vaccine, at the age of 55 years old, on 24Mar2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient experienced Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face. Ended up in hospital 19Apr2021. Outcome of the event was unknown. Information about the lot/batch number has been requested.
55 2021-06-30 peripheral swelling Very strange rash on her right hand above the wrist and inside of the arm/ Rash on her left breast; ... Read more
Very strange rash on her right hand above the wrist and inside of the arm/ Rash on her left breast; Rash, several bumps as they are very itchy; Rash on her left breast which after few hours become like a very red blood; High fever; Muscle pain; Whole body was hurting/ everything was hurting; Swollen hands; Feet were hurting; Shivering; She did not have much power/ Shutting down; Very tired; Catching cold; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0168), via an unspecified route of administration in left arm on 16Jun2021 (at the age of 55-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were none. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8736), via an unspecified route of administration on 26May2021 (at the age of 55-year-old) as dose 1, single for COVID-19 immunisation. It was reported that, reporter stated, yes, she would like to report unusual reaction to the Pfizer that she got on 16Jun2021. Patient know that it was normal to have fever, shingles etc. but she got a very strange rash on her right hand above the wrist and inside of the arm on 17Jun2021. The rash look like a chicken pox. Rash, several bumps as they are very itchy on 17Jun2021, and she was not touching them and also, she have rash on her left breast which after few hours become like a very red blood on 17Jun2021. Still experiencing: Reporter stated, no. First was a high fever on 17Jun2021 and she felt like a muscle pain on 17Jun2021, everything was hurting like swollen hands on 17Jun2021, the feet were hurting on 17Jun2021, whole body was hurting on 17Jun2021. Patient got shivering and high fever on 17Jun2021. Patient took the Tylenol, she did not have much power on 17Jun2021. Patient was like a very tired on 17Jun2021 but in the few hours she have to repeat that Tylenol because the fever return it and in the evening in the same situation, she was shutting down on 17Jun2021, she had fever she have 101. Patient took the Tylenol, she took the nap. When she woke up, she noticed the rashes. It was in the afternoon. The rashes appeared on her right arm and on her breast. No fever she took the Tylenol at 8:00 clock. Patient slept without any problems during the night. Patient still feel like she was catching cold on an unspecified date in Jun2021, but it was like 20% not that much and she do not thought so she take Tylenol. This should be noted that itchy portion to warn other people taking the vaccine so that they would be aware of such things. No investigation assessment. The patient underwent lab test and procedure which included body temperature: 101 on an unspecified date in Jun2021. The patient was treated with Tylenol for the events shivering, feet were hurting, swollen hands, whole body was hurting/ everything was hurting, muscle pain, high fever. The outcome of the events rash, high fever, muscle pain, swollen hands, shivering was resolving and unknown for the other events. Information on lot/batch number was available. Additional information has been requested.
55 2021-06-30 swelling Hot pain spots on top and back of head progressing to an intense nerve pain over two weeks moving f... Read more
Hot pain spots on top and back of head progressing to an intense nerve pain over two weeks moving from head down the back.; Hot pain spots on top and back of head progressing to an intense nerve pain over two weeks moving from head down the back.; sleepness nights; a burning pain at top of vertebrae with a swelling feeling inside the head; a burning pain at top of vertebrae with a swelling feeling inside the head; This is a spontaneous report from a contactable consumer reporting for herself. This 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL3247) at single dose in left arm at age of 55-year-old on 02Apr2021 11:00 for COVID-19 immunization. The first dose was on 05Mar2021 11:00 in left arm, Lot number: EN6204, at age of 55-year-old. Medical history included endometriosis from 1999; trigeminal nerve neuralgia from 2011. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021 15:00, patent had hot pain spots on top and back of head progressing to an intense nerve pain over two weeks moving from head down the back. Pain continued with similar intensity over the next 7 weeks causing sleepiness nights until treated with steroids at week 9 where sleeping became possible. Condition continued at week 10 but a burning pain at top of vertebrae with a swelling feeling inside the head. Steroid treatment was ongoing. The adverse events result doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The treatment received for the adverse events was gabapentin, acyclovir, prednisone. The outcome of events was not recovered. Follow up attempts are needed. Additional information can be requested.
55 2021-07-02 lymph node swelling Swollen lymph nodes under right arm; This is a spontaneous report from a contactable consumer, the p... Read more
Swollen lymph nodes under right arm; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the left arm on 13Mar2021 at 11:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and acid reflux. The patient had known sulfa allergy. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient received other medications (unspecified) within 2 weeks of vaccination. On 20Mar2021 at 10:00, after one week of vaccination, the patient experienced swollen lymph nodes under right arm. The patient did not receive any treatment for the event. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of swollen lymph nodes under right arm was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
55 2021-07-04 lymph node swelling A golf ball size swollen lymph node in the armpit and then on day two it tripled in size and traver... Read more
A golf ball size swollen lymph node in the armpit and then on day two it tripled in size and traversed down the entire axillary area. On day two I also had soreness at site of injection and some pain. It was difficult lifting my arm. My fiancée who was a medic for 30 yrs did research online and found this had been reported during some tests. He agreed to watch it closely and marked border areas to ensure no spreading/growth. We closed my business for 7 days & It cleared up after a week gradually improving each day until resolved...utilized some Motrin to treat duscomfort. FYI I have a mammogram later this week. He us adamant I get this on file as May gave future impact if boosters needed later, as such he is filling this out for me.
55 2021-07-04 swelling, swelling face Patient reported to pharmacy on July 5th to report swelling and pain in right side of face and neck.... Read more
Patient reported to pharmacy on July 5th to report swelling and pain in right side of face and neck. She was on her way to emergency room or clinic seeking steroids to calm the reaction
55 2021-07-05 swelling face Throat tight. Patient stating inflammation in throat and changes in voice. Rash at administration si... Read more
Throat tight. Patient stating inflammation in throat and changes in voice. Rash at administration site. Shortness of breath, Puffy face
55 2021-07-06 swelling face Left arm and then left hand began to tingle. Left inside mouth cheek began to swell. Slowly my tongu... Read more
Left arm and then left hand began to tingle. Left inside mouth cheek began to swell. Slowly my tongue, uvula, throat, and top of mouth began to swell and feel raw. I did not call for the medic. I must have been in shock from the reaction. I took a Benadryl tablet there and two more during that day. I developed hives on my left hand palm, one on my right palm, and a couple on both wrists. I took one Benadryl for each of the next three days and as needed during the next two weeks.
55 2021-07-07 peripheral swelling, axillary mass Pt. describes swelling in arm with lumps around axilla and mid upper ark States fourth and fifth fin... Read more
Pt. describes swelling in arm with lumps around axilla and mid upper ark States fourth and fifth fingers on left had are numb and weak.
55 2021-07-08 lymph node swelling, lymph node pain I took the first dose of the vaccine(lot number) on 05/19/2021, and I took the second dose (lot numb... Read more
I took the first dose of the vaccine(lot number) on 05/19/2021, and I took the second dose (lot number EW0196) on 06/16/2021,The injection site started to swell and be very painful and the lymph nodes under the armpit were very swollen and painful, I also had tiredness and a headache and I don't really get headaches. The whole left arm was also very painful. This lasted for two and a half days.
55 2021-07-08 lymph node swelling, swelling face face swelling swollen lymp nodes, site pain, site redness, itching, headaches, sick
55 2021-07-08 peripheral swelling sharp pain; Developed swelling on both arms on elbow joints and on knee joints.; Developed swelling ... Read more
sharp pain; Developed swelling on both arms on elbow joints and on knee joints.; Developed swelling on both arms on elbow joints and on knee joints.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: SMPHO ER2613) via an unspecified route of administration in the right arm on 25Mar2021 at 10:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and asthma. The patient had a history of allergy to penicillin and sulfa drugs. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: SMPHO EN6202) via an unspecified route of administration in the left arm on 02Mar2021 at 11:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 11:30, the patient had experienced swelling of both arms, elbow joints, knee joints and at 16:30 (after 06 hours of vaccination), she had experienced sharp pain which ran through the right side of the body. The patient did not receive any treatment for the adverse events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events developed swelling on both arms on elbow joints and on knee joints and sharp pain was unknown at the time of report. No follow-up attempts are needed. No further information is expected.
55 2021-07-12 swelling Severe hives on ankles, itchy, red raised hives, swollen and still have mild moderate hives at vario... Read more
Severe hives on ankles, itchy, red raised hives, swollen and still have mild moderate hives at various spots; Swollen lips; Itchy; Swollen; Warm injection site; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the right arm on 18Mar2021 at 11:15 (at the age of 37-years-old), as single dose for COVID-19 immunisation. Medical history included chronic idiopathic urticaria. The patient was allergic to amoxicillin. Concomitant medications included cetirizine hydrochloride (Zyrtec), escitalopram oxalate (LEXAPRO), lorazepam (ATIVAN), hydroxyzine (MANUFACTURER UNKNOWN); all taken for unknown indication and from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 13:30, the patient experienced itchy, swollen and warm injection site (itchiness was continued). On 22Mar2021 (Day 4 after shot), the patient experienced severe hives on ankles, itchy, red raised hives, swollen and still have mild moderate hives at various spots and including swollen lips. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events and included self-treatment with ZYRTEC and ZANTAC. The clinical outcomes of the events itchy, swelling, Injection site warmth, hives and swollen lips was not resolved at the time of report. No follow up attempts are possible. No further information is expected.
55 2021-07-12 swelling Hives; heat that comes from inside body that itches; itching from the inside like poking through ski... Read more
Hives; heat that comes from inside body that itches; itching from the inside like poking through skin; bruises; broken skin; skin raises up and spreads all over and gets bigger and bigger and gets more itchy and scratches more and skin breaks; This is a spontaneous report from a Pfizer sponsored program. A 54-year-old female contactable consumer (patient) reported. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 29May2021 (age at the time of vaccination was 55-year-old) as dose 1, single, dose 2 via an unspecified route of administration, administered in Arm Left on 19Jun2021 (Batch/Lot number was not reported) as dose 2, single to prevent getting covid and my kids wanted me to get it (reported verbatim). Medical history included flushing and allergy to chemicals from an unknown date and unknown if ongoing (Caller states that she is allergic to alcohol and she has the Asian flush). Hysterectomy from an unknown date and unknown if ongoing (She had a hysterectomy 17 years ago). Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) and any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none. The adverse events following prior vaccinations was reported as none. She states the only medication that she added is Metamucil powder in her smoothie every other day. She says she is pretty healthy. She has family members that also have Asian flush. She states she has several cousins who drink beer and then have red face but no hives. She has not had alcohol since she was 19 years old because she states if she does, she has to pay for it big time). Concomitant medications included plantago ovata (METAMUCIL [PLANTAGO OVATA]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other medication prior to COVID-19 Vaccine. The patient did not experience any adverse event prior to COVID-19 Vaccine. On 29May2021, the patient reported that she had her first dose, and she was unsure what was going on, so she waited 5 weeks to see if she was thinking correctly. The caller stated she felt a heat that comes from inside her body that itches, and she scratches it without knowing and itching from the inside like poking through skin. She wakes up with hives, bruises (Hours later she notices bruising), and broken skin. She reported that skin raises up and spreads all over and gets bigger and bigger and gets more itchy and scratches more and skin breaks. Hours later she notices bruising. She stated that she was allergic to alcohol and that this happened when she comes into contact with it. Caller states she got the first vaccine on 29 May 2021 and she waited 5 weeks to get the second vaccine on 19 Jun 2021. She did not want to make her reaction worse. She states her pharmacist told her this was ok. Caller stated she does not know what was in the vaccine. She just wanted to call in and let us know just in case someone else has the same problem as her. Caller stated she was part of the study. She stated that anyone like her should be aware of this. Caller stated she asked pharmacist about events and was told to go to emergency room for testing. Caller stated that the ER said there is nothing to test. She stated she went to ER and told doctor her race, and most had Asian flush which was lack of digesting alcohol. She said ER could not give her steroids because of COVID, might counteract the vaccine. Caller said the ER doctor did not have information since COVID was only 6 months out. She was told to take Benadryl and use hydrocortisone. She says Benadryl makes her sleepy so she does not take it. Hydrocortisone does not help with the hives and didn't make the hives go away. Caller stated that her daughter got the same vaccine at the same place and did not have any problems. Treatment medication included cold shower, Benadryl, and hydrocortisone. She said Benadryl made her sleepy, so she did not take it. Outcome of all the events was reported as unknown. Information about batch no/lot no has been requested
55 2021-07-17 lymph node pain, lymph node swelling Swelling of lymph nodes in Left armpit. Very sore to touch.; Swelling of lymph nodes in Left armpit... Read more
Swelling of lymph nodes in Left armpit. Very sore to touch.; Swelling of lymph nodes in Left armpit. Very sore to touch.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were reported as no. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 02Mar2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination. Since having the vaccine the patient had not undergone a COVID-19 test. The patient experienced swelling of lymph nodes in left armpit which were very sore to touch on 23Mar2021 at 20:00. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was taken as a result of the adverse events. The clinical outcome of the event swollen lymph nodes and the lymph node pain were not recovered at the time of this report. No follow-up attempts possible. No further information expected.
55 2021-07-17 peripheral swelling Weakness; Warm heating sensation in body mostly in breast; pressure between shoulder blades; Swollen... Read more
Weakness; Warm heating sensation in body mostly in breast; pressure between shoulder blades; Swollen arms; Blue/ grey spots on upper thigh; Heaviness in arms; Pressure in head; Tingling sensation in head; Numbness in left arm fingers; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in left arm on 03Mar2021 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in left arm on 08Feb2021, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04Mar2021, the patient experienced weakness, warm heating sensation in body mostly in breast, pressure between shoulder blades, swollen arms, blue/ grey spots on upper thigh, heaviness in arms, pressure and tingling sensation in head, and numbness in left arm fingers. It was reported that patient was seen by primary care provider, emergency room department, infectious disease specialist and rheumatologist. No answers to what was happening, other than this could be a reaction to the vaccine. The patient reported that, it was 22 days since received second Pfizer shot and was still in pain, she felt like a different person and not getting any help or find answers to what was going on. The events resulted in doctor or other healthcare professional office/clinic visit/ emergency visit. The patient did not receive any treatment for the events. The clinical outcome of events weakness, sensation of warmth, sensation of pressure, swollen arm, spot pigmented, heaviness in arm, head pressure, tingling sensation and numbness in fingers was not resolved. No follow-up attempts are needed. No further information is expected.
55 2021-07-17 swelling, swelling face On Friday, 4/9, I experienced a fever of 103.3, sore throat, earache on the left side, swelling on t... Read more
On Friday, 4/9, I experienced a fever of 103.3, sore throat, earache on the left side, swelling on the neck and face, swollen tonsils, white stains on my tonsils, headache, toothache, and terrible muscle pain. When I went to the emergency room on 4/10, I received a dose of dexamethasone 15ml and was instructed to take Tylenol. On 4/11, I had no further symptoms after taking the dexamethasone. On 4/12 in the AM, my fever (101.4 F), sore throat, earache on the left side, toothache, headache, more swelling on the neck started to occur. I took Tylenol for the symptoms.; I was feeling very tired and weak the entire time and experienced severe dizziness. On 4/13, my body started to bruise up on the left side of my body (foot). Then, I developed a bruise on my left shin and left hand. I had severe tremors and shakes. I went back to the emergency room on 4/13 and lost consciousness in the waiting room. My left tonsil started to develop black spots on it. My doctors at the emergency room did not know what this was. I was given dexamethasone via IV and clindamycin 150MG X3/day X 6 days. On 4/13, my left buttocks developed shingles. On 4/16, I had a visit at my doctor's. I still had swelling on the face and neck, my bruises grew in size. My doctor prescribed me Valacyclovir 1gm X1 tablet X 3/day X 1 week. From 4./16, these symptoms persisted for about 10 days before I began to feel better.
55 2021-07-19 oral herpes Patient reports she broke out in cold sores starting 2 days after receiving the vaccine, extending f... Read more
Patient reports she broke out in cold sores starting 2 days after receiving the vaccine, extending from her upper lip all the way down to her chin. Cold sores are still visible at time of reporting (7/20/21). Patient reports NO other symptoms other than described above.
55 2021-07-22 sepsis Sepsis; appendicitis; intussusception of the distaileum; allergy attack; fever 100.6-102.6; Upset st... Read more
Sepsis; appendicitis; intussusception of the distaileum; allergy attack; fever 100.6-102.6; Upset stomach; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Batch/Lot Number: EN6204) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Pending clarification) (Batch/Lot Number: ER8730) as SINGLE DOSE for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included breast cancer survivor, unspecified allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX) taken for immunisation on 12Feb2021. The patient received other medications within 2 weeks of vaccination. The patient experienced allergy attack, fever 100.6-102.6, upset stomach on 23May2021, on 26May2021 Computerised tomogram (CT) showed intussusception of the dista ileum. Went to emergency room (ER), treated for sepsis. Surgery 26May2021 showed appendix wrapped around small intestine forcing telescoping. Appendix and adhesions and lymph node removed. Biopsy showed appendicitis. Adverse events resulted in emergency room/department or urgent care and hospitalization. Patient was admitted to hospitalization for 3 days. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Covid test (Nasal Swab): negative on 26May2021, and Covid test (Saliva Test): negative on 25May2021. The outcome of the events was recovered.
55 2021-07-22 swelling face This is a spontaneous report from a contactable other healthcare professional. A 55-year-old non-pre... Read more
This is a spontaneous report from a contactable other healthcare professional. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via intramuscular route of administration in the right arm on 01Apr2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, high blood pressure, knee issues, back problems and bladder issues. The patient was allergic to food, medications, or other products. The patient received unspecified medication within two weeks prior to the vaccination. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via intramuscular route of administration in the right arm on 11Mar2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 15:30, half an hour after vaccination, the patient felt right side of face and throat were swollen up. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the events right side of face and throat were swollen up were resolved on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
55 2021-07-24 swelling face Hives, swelling in face & throat, severe itching & heat
55 2021-07-25 lymph node swelling i recently am diagnosed with the lymph nodes. I think it's because of the vaccination
55 2021-07-27 lymph node swelling Swollen lymph nodes; Swollen tongue at time of administration; This is a spontaneous report from a c... Read more
Swollen lymph nodes; Swollen tongue at time of administration; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 01Apr2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included allergy, asthma and bipolar. Concomitant medications included lamotrigine (LAMICTAL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), clonazepam (KLONOPIN) and primidone (MANUFACTURER UNKNOWN) on an unknown dates for unknown indication. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 12Mar2021 at 14:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced swollen tongue at the time of administration. On 03Apr2021 at 16:00 two days after vaccination, the patient experienced swollen lymph nodes. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office or clinic and emergency room or department or urgent care. The clinical outcome of the events swollen tongue and swollen lymph nodes were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
55 2021-07-27 lymphatic obstruction Swelling began apx 16 hrs later in left breast area, beginning to show in right breast, now concerne... Read more
Swelling began apx 16 hrs later in left breast area, beginning to show in right breast, now concerned for swelling to continue and/or lymphadema; lymphadema; Anatomical Location- Left leg; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection and Lot Number: EP7533), via an unspecified route of administration, in Leg Left on 02Apr2021 12:45 (at the age of 55-years-old) as dose 1, single for COVID-19 immunization. Medical history included breast cancer (Still receiving treatment, Double mastectomy 02Jun for breast cancer, incl lymph node removal right side. Expanders placed during surgery for implants at later date) and known allergies: Penicillin. Concomitant medications included gabapentin, trazodone, celecoxib (CELEXA) and ergocalciferol (ERGOCALCIFEROL). The patient experienced swelling began apx 16 hrs later in left breast area, beginning to show in right breast, now concerned for swelling to continue and/or lymphadema on 03Apr2021 07:00, anatomical location- left leg on 02Apr2021 and lymphadema on 03Apr2021 07:00. Prior and Since the vaccination, was the patient diagnosed with COVID-19 reported as no. For breast swelling and Lymphedema emergency room visit reported as yes and the treatment were reported as unknown. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
55 2021-07-27 swelling Stinging throat; Swollen neck; Sore arm; Nausea; Dizzy; Very weak; Ear ache; Light sensitivity; Body... Read more
Stinging throat; Swollen neck; Sore arm; Nausea; Dizzy; Very weak; Ear ache; Light sensitivity; Body aches; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733), via an unspecified route of administration in the left arm on 03Apr2021 at 14:30 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid. Concomitant medication included levothyroxine sodium (SYNTHROID 175), vitamin B+ (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), vitamin E (MANUFACTURER UNKNOWN), all taken from unknown dates for unspecified indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 03Mar2021 at 15:00, the patient experienced stinging throat, swollen neck, sore arm, nausea, dizzy, very weak, ear ache, light sensitivity and body aches. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events stinging throat, swollen neck, sore arm, nausea, dizzy, very weak, ear ache, light sensitivity and body aches was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
55 2021-07-28 lymph node pain, lymph node swelling Brief Dizziness/multiple heart palpitations(few with dizziness)/1 episode of brief tachycardia with ... Read more
Brief Dizziness/multiple heart palpitations(few with dizziness)/1 episode of brief tachycardia with dizziness /dry cough. All sx x?s five months/enlarged tender supraclavicular lymph nodes x?s 6 months (currently slightly enlarged and non tender)/loose stools x?s two months
55 2021-07-28 lymph node swelling Diarrhea; Swollen lymph; Rash located in thetummy area; This is a spontaneous report from a contacta... Read more
Diarrhea; Swollen lymph; Rash located in thetummy area; This is a spontaneous report from a contactable healthcare professional, the patient. A 55-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via intramuscular route of administration in the right arm on 05Apr2021 at 13:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had a history of allergies to medications, food, or other products. The patient had received other medications (unspecified) within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021, the patient had experienced swollen lymph, rash located in the tummy area and diarrhea. The patient did not receive any treatment for the reported events. The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swollen lymph, rash located in the tummy area and diarrhea was resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
55 2021-07-28 peripheral swelling weird feeling in my mouth; red, however like broken blood vessels near mouth and cheek; Lips still f... Read more
weird feeling in my mouth; red, however like broken blood vessels near mouth and cheek; Lips still feel strange.; Itchy, left had; Itchy left had and swollen; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 06Apr2021 at 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic reaction to antibiotics and penicillin allergy. Concomitant medications included tramadol (MANUFACTURER UNKNOWN), cannabis sativa (CANNABIS), lisinopril (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT) all from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 16:00 the patient experienced weird feeling in mouth, sat for 20 min, checked out. Took off mask and was red, however like broken blood vessels near mouth and cheek. Itchy left hand and swollen. Lips still feel strange. No shortness of breath or swelling. Patient took Benadryl. The events resulted in emergency room/department or urgent care. The clinical outcome of events oral discomfort, redness of face, lip discomfort, itching, swollen arm was resolving at the time of reporting. No follow-up attempts are needed. No further information is expected.
55 2021-07-28 swelling face she grinds her teeth; Second dose: severe pain in the right side of her face; Second dose: right sid... Read more
she grinds her teeth; Second dose: severe pain in the right side of her face; Second dose: right side of her face has stayed swollen and sore; Second dose: right eye is sore; her right temple is sore; Second dose: slight deviated septum; woke up in the middle of the night again with horrible pain; Second dose: brain felt like it was to big for her skull; Second dose: her eyes felt like they were going to fall out; Second dose: vomiting; Second dose: diarrhea; Second dose: resting heart rate of 97 beats per minute which is around 30 beats per minute higher than her normal resting heart rate; Second dose: chest pain; Second dose: mouth hurt horribly/still having an issue waking up in pain; next day after receiving the second dose she was definitely sick/ungodly sick; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 14Apr2021 15:40 (at the age of 55-year-old) (Batch/Lot Number: EW0153; Expiration Date: 31Jul2021) as dose 2, single for covid-19 immunisation. Medical history included reduce acid (hyperacidity). Concomitant medication included omeprazole taken as acid reducer. The patient received first dose of Shingrix on 19Jun2020 as immunization and experienced arm was extremely sore/ caused a really really really sore arm and second dose of Shingrix on 31Aug2020; flu vaccine on 23Nov2020; and first dose of bnt162b2 for covid-19 immunisation on 23Mar2021 and experienced soreness at the injection site that was pretty minimal; and she stated she felt fine after getting both doses of the vaccine. On 15Apr2021, the next day after receiving the second dose, she was definitely sick, she almost called an ambulance. She had rescheduled a dental appointment 12 days after the 2nd dose to have a cavity filled and she was given Novocain at both dental appointment on 26Apr2021 and 28Apr2021. The day after, on 27Apr2021, she felt ungodly sick, her brain felt like it was too big for her skull, her eyes felt like they were going to fall out, she had vomiting, diarrhea and a resting heart rate of 97 beats per minute which was around 30 beats per minute higher than her normal resting heart rate. She does normally check her heart rate and it's normally in the upper 60's beats per minute and lower 70's beats per minute. She also had chest pain and that prompted her to check her heart rate. Even though it was 97 beats per minute she knows that was normal range but it's high for her. She has had x-rays, CAT scans and her doctor's haven't found anything. She felt fine up until her dentist appointment and felt fine until she received the Novocain. She was asking if this was related to the Covid 19 vaccine were these side effects to be expected, and how long will these symptoms last. She has gone to several doctor appointments since receiving the Covid 19 vaccine and no one can find anything. She has had dental x-rays and endodontist took 3D dental x-rays to check for nerve issues for facial pain and swelling and she had a facial scan and had seen an Ear, Nose, and Throat doctor. The only thing anyone can suggest was that she grinds her teeth so she got a mouth guard. On an unspecified date, she had some severe pain in the right side of her face the other day so she put ice on it. She has taken Aleve, Tylenol, and Ibuprofen and the pain doesn't stop. It took hours, sometimes 4 hours before her face will start feeling better. But the pain has been consistent the last few days. The right side of her face has stayed swollen and sore. She clarified she was having right side facial pain and right-side facial swelling. She stopped going to the doctor because the doctor's aren't finding anything. She never knows when her face will start hurting, her face was still swollen today, 14Jul2021, and a little sore but it's not excruciating like it has been. On an unspecified date, her right eye was sore, and her right temple was sore. She can feel that her right face was swollen. She reported she had the first filling in a small cavity at the dentist on 26Apr2021. Later that night, she woke up and her mouth hurt horribly. She had to go back to the dentist on 28Apr2021 for another cavity filling on the other side of her mouth and she mentioned to the dentist that she had felt when the Novocain wore off with the small filling and the dentist told her that she shouldn't have felt anything because the cavity was so small. That Friday, 30Apr2021, she woke up in the middle of the night again with horrible pain and she thought this was weird. On Sunday, 02May2021 she had laid down to take a nap and woke up again in pain. On 03May2021, her dentist had her come back in and took dental x-rays again and he did not see what could be causing her pain. He thought maybe the pain could be related to a nerve issue. She was able to get an appointment with an endodontist the next morning, 04May2021 and had the 3D dental x-rays and the endodontist said it didn't look like she needed any root canal, and the nerves looked okay. The endodontist told her she grinds her teeth so he suggested a mouth guard. He suggested she try an over the counter mouth guard first. She got the mouth guard and a couple days later she was still having an issue waking up in pain. She called her primary care doctor and saw him on 20May2021. Her primary care doctor sent her for a CT scan on 26May2021. She doesn't think it was of her whole head but she's not sure. She thinks it was just a CT scan of the right side of her face and head. On 09Jun2021, she saw an Ear, Nose and Throat doctor and he told her she had a slight deviated septum but most people have a slight deviated septum. That doctor told her that he didn't find anything in her ears, nose, or throat that would be causing her issue. So, she's just been living with it, not ever knowing when her pain will come back. The pain used to just occur at night but the pain was starting to bother her during the day and her face was staying swollen. The Ibuprofen, the Aleve, and nothing was taking the pain away. She suggested that maybe there's an interaction with the Covid 19 vaccine and her being deathly sick after getting the vaccine that created this issue. She had seen different doctors and cannot tell if the vaccine has something to do with it. Her primary care doctor also gave her a prescription of Amitriptyline HCl 25 mg to take every night at bedtime as needed. She can't take it because it makes her completely sleepy the whole next day. She'll wake up in the morning and by 8:30AM-9:00AM she wants to take a nap. She tried taking half a tablet but it still makes her sleepy. She guesses she just can't take that medicine. The medications she has tried that aren't taking the pain away were as follows: acetaminophen 500mg, naproxen sodium 220mg, Orajel didn't work either and ibuprofen 200mg. She had put the Ibuprofen up because her husband was on so many medications and he can't take certain medications for pain so she puts her medications out of reach because her husband had a stroke and can't remember what medicine he can take and what he can't take. She started the other day taking Aspirin 81mg thinking maybe that will help if she takes a low dose Aspirin 81mg every day, no help yet. She was also prescribed Levofloxacin 500mg on 23Apr2021 for 10 days. She reported she did have a regular medical checkup with annual blood work on the Monday after the second Covid 19 vaccine. There were no additional vaccines administered on the same day of the covid19 vaccine and no prior vaccinations (within 4 weeks). Outcome of events vomiting, diarrhea recovered on an unspecified date; second dose: severe pain in the right side of her face, right side of her face has stayed swollen and sore, right eye is sore, her right temple is sore, second dose: mouth hurt horribly/still having an issue waking up in pain, woke up in the middle of the night again with horrible pain was not recovered; and outcome of the rest of events was unknown.
56 2021-01-03 anaphylactic shock They have my injection listed as Moderna which is a mistake. The Manufacturer is Pfizer. On the 23rd... Read more
They have my injection listed as Moderna which is a mistake. The Manufacturer is Pfizer. On the 23rd. I went into anaphalactic shock admitted to the ER, given an epinephrine drip, I was given iv bolises, chest xray, vitals were taken and blood was drawn. ABGs and chest xray and lactic acid tests were administered. I have to carry a epi pen and need to see a pulmonologist, I have triggers now where I need an emergency inhalor and was put on a course of steroids and my heartbeat is 20 beats higher than usual. I was really tired and having abdominal pain .
56 2021-01-03 lymph node swelling, white blood cell count increased This patient is a 56 y.o. female presenting to the emergency department with a chief complaint of a ... Read more
This patient is a 56 y.o. female presenting to the emergency department with a chief complaint of a possible reaction to the COVID vaccine onset 2 days ago. The patient states that she has had a fever, chills, adenopathy, and body aches since her vaccination. Her highest recorded temperature was 101F, and she has been taking Tylenol. She states that her biggest concern is the adenopathy under her right armpit which is painful to touch. She denies any masses. She saw her PCP on 12/24 and had blood work done, which showed an elevated white count of 17.
56 2021-01-03 swelling face After I got the vaccine around 30 minutes later I started to feel a headache and pain on my face was... Read more
After I got the vaccine around 30 minutes later I started to feel a headache and pain on my face was not to bad and I tought is a normal symptom but the pain and swelling an my face is increasing every day, even my teeth hurts and I'm taking Gabapentin 100MG 3 times a day. I am not sure if the vaccine components triggered my Trigeminal Neuralgia and if it's okay to get the second dose, I will see my Dr. tomorrow 01/05/21
56 2021-01-03 swelling 12/31/20 - Pain and swelling at injection site, as well as pain and swelling in left arm pit that is... Read more
12/31/20 - Pain and swelling at injection site, as well as pain and swelling in left arm pit that is not relieved with Tylenol. This has continued beyond 72 hours.
56 2021-01-06 swelling Patient received COVID vaccine at 0939, during observation period reported tingling of tongue and li... Read more
Patient received COVID vaccine at 0939, during observation period reported tingling of tongue and lips approx. at 1010. Benadryl 25mg by mouth administered. Patient continued to be monitored for additional 1hr. Benadryl improved symptoms, patient denied SOB and remained calm throughout. Swelling and tingling improved. Patient went back to work in hospital where received vaccine. Patient confident in monitoring return of symptoms while on site working. Patient reports list of allergies and has dealt with symptoms of allergic reactions before. This RN checked on patient after vaccine clinic and residual tingling remained but otherwise patient "felt good". Called patient at 1707 to follow up. Patient reports minor residual burning on lip otherwise other symptoms resolved. Continues to denies difficulty breathing, " I feel fine"
56 2021-01-07 lymph node swelling HEAD ACHE, MUSCULAR ACHES, FEVER, CHEST PAIN AND IRREGULAR HEART RATE, EDEMA, ITCH, ERYTHEMA, ENLARG... Read more
HEAD ACHE, MUSCULAR ACHES, FEVER, CHEST PAIN AND IRREGULAR HEART RATE, EDEMA, ITCH, ERYTHEMA, ENLARGEMENT OF LYMPH NODE
56 2021-01-07 peripheral swelling ON 1/4/21, DEVELOPED FEVER, ARM SWELLING, CHILLS, AND BODY ACHES AROUND 8PM AND LASTED ABOUT 24 HOUR... Read more
ON 1/4/21, DEVELOPED FEVER, ARM SWELLING, CHILLS, AND BODY ACHES AROUND 8PM AND LASTED ABOUT 24 HOURS.
56 2021-01-09 peripheral swelling 1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, ... Read more
1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, total body/muscle/joint aches, migraine headache, nausea, heart palpitations, as well as very sore, swollen arm. Had to spend the day in bed. Most symptoms relieved by the next 24 hours except arm pain and fatigue. 2nd vaccine: Similar, but worse symptoms developed approximately 12 hours after vaccine. All of the aforementioned symptoms, but fever of 101.4 and arm wasn't quite as sore. As above, had to spend a day in bed.
56 2021-01-10 anaphylactic reaction Anaphylactic reaction
56 2021-01-10 lymph node swelling SWOLLEN & SORE LYMPH NODE UNDER LEFT ARM PIT, NOTICED ON FRIDAY 1/8/21 THOUGH 1/10/21 AM. SWELLING ... Read more
SWOLLEN & SORE LYMPH NODE UNDER LEFT ARM PIT, NOTICED ON FRIDAY 1/8/21 THOUGH 1/10/21 AM. SWELLING STARTED TO DECREASE BY SUNDAY AFTERNOON 1/8/21, SWELLING DOWN BY SUNDAY NIGHT 1/8/21
56 2021-01-10 peripheral swelling 10 days post vaccination presented to ED with LUE swelling redness and pain. Treated with antibiotic... Read more
10 days post vaccination presented to ED with LUE swelling redness and pain. Treated with antibiotics and f/u w Allergy to determine whether to have second dose
56 2021-01-10 swelling Armpit is swollen
56 2021-01-11 swelling face Date/time/when adverse event started: 12/31/20 noticed a white streak noted from R eyelid straight ... Read more
Date/time/when adverse event started: 12/31/20 noticed a white streak noted from R eyelid straight down to the R jaw. Numbness, tingling feeling from R mid cheek moving toward R ear. Swelling of the face at this site as well. Paresthesia feeling, abnormal sensations at this same area of the face. These issues continues even to today. Initially, I experienced a H/A on the R sided above my eye which has not been occurring lately. On 1/8/21 I was seen by the NP at and was dx. with Bell?s Palsy. The NP noticed that when I initially speak my mouth doesn?t move properly, but once I get my words started then my mouth moves properly. My smile is noticed to be abnormal. The NP then sent me to ER for evaluation with the dx. Of Bell?s Palsy and because of another potential medical condition there?s a high risk for a stroke. A CT scan and blood work were obtained. A f/u script for a MRI of the brain has been ordered as well. Discharge paperwork states: Bell?s Palsy. Currently, I am taking a tapering dose of Prednisone and Valtrex as prescribed.
56 2021-01-12 lymphatic obstruction Fever chills 12 hours after shot, lymphadema in umderarm 48 hours later
56 2021-01-12 peripheral swelling UrticariaPruritus swelling in fingers Narrative:
56 2021-01-12 peripheral swelling UrticariaPruritus swelling in fingers Narrative:
56 2021-01-13 lymph node pain, lymph node swelling A week later I felt tenderness on my clavicle and discovered a swollen left supraclavicular lymph no... Read more
A week later I felt tenderness on my clavicle and discovered a swollen left supraclavicular lymph node still there and tender a week later
56 2021-01-13 swelling PATIENT HAS SWOLLEN, RED FACE, HEADACHE, INCREASE BLOOD PRESSURE, INCREASE HEART RATE, TROUBLE BREAT... Read more
PATIENT HAS SWOLLEN, RED FACE, HEADACHE, INCREASE BLOOD PRESSURE, INCREASE HEART RATE, TROUBLE BREATHING AFTER 2 HOURS OF ADMINISTRATION OF VACCINE. PATIENT WENT TO THE ER AND GOT EPIPEN AND ORAL BENADRYL AND ORAL ATIVAN. PATIENT IS RECOVERING NOW.
56 2021-01-17 lymph node swelling swollen axillary lymph node under left arm
56 2021-01-17 swelling face, peripheral swelling I sat for 15 minutes and felt fine but when I was leaving I had to climb up a set of stairs, after d... Read more
I sat for 15 minutes and felt fine but when I was leaving I had to climb up a set of stairs, after doing that I felt light headed and out of breath. That continued for about 15-20 minutes. At 30 minutes after the injection my voice went hoarse. About an hour after I had a serve bullet like headache in one point in my head, I took Tylenol and lasted for about 5 hours. I started taking Benadryl (25mg), the headed improved, but when I woke up in the morning the next day I had all over swelling to the the point where I couldn't make a fist and had facial swelling . The facial swelling lasted for 5 days. My co worker took my vitals signs but everything was normal. For the next 5 days I had facial swelling that increased, hands got better. I continued to Benadryl . After the 5th day things finally started to get better. I did go back to have my second dose. I contacted my PCP but he was out of town .
56 2021-01-18 lymph node swelling Approximately 24 hours after receiving the vaccine, left armpit and under arm became swollen and ten... Read more
Approximately 24 hours after receiving the vaccine, left armpit and under arm became swollen and tender to the touch. Notified primary care physician during routine visit, PCP advised to notify her if symptoms did not resolve. Swelling resolved 4 days after onset, arm remained somewhat sensitive to the touch. Patient was also extremely tired for 2 days after the vaccine but otherwise fine.
56 2021-01-20 lymph node swelling 3 hours post innoculation, sore throat with swollen glands, chills, shaking and a mild headache. S... Read more
3 hours post innoculation, sore throat with swollen glands, chills, shaking and a mild headache. Shortly thereafter, started experiencing uncontrolled itching and my skin was bright red (flushed) from above pubic bone and up to top of my head. (nothing on lower extremities). No fever (98.1) and no visible rash. The itching became so uncontrollable, I took 25mg Benadryl and remained taking it every 4 hours until 1/21/21. A very fine, red rash appeared on 1/20/21 in the early morning. The rash was, mainly at my fatty areas, breasts, abdomen and hips, but the Benadryl helped to control the itching. The Benadryl did not take away the itching entirely. As of this morning, the rash has faded, but i'm still itching, mildly, in my abdomen and out edges of my breasts. I am going to try to stop the Benadryl this morning and see how I do. If not better, will go see my PCP.
56 2021-01-20 peripheral swelling Body ache; Headache; Light fever; Sore arm; neck pain; It's swollen under my right arm; This is a sp... Read more
Body ache; Headache; Light fever; Sore arm; neck pain; It's swollen under my right arm; This is a spontaneous report from a contactable (patient). A 56-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm, on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included hydrochlorothiazide for hypertension. Patient reported that on Friday (Jan2021), she took her first dose of vaccine. She didn't have any reaction right away but after like 8 to 9 hours in Jan2021 she had body ache and headache, light fever. She knew this sore arm would be, it always will be there, she knew it's now under her arm, it's swollen under her right arm that she took the vaccine, was swollen. Patient took ibuprofen (MOTRIN, Expiry Date: Jun2023) 200 mg orally two times a day for treatment. Her body does not as hurt as it used to after taking it, but she still has neck pain and her arms still hurting and right now under her right arm that she took the shot that was swollen, patient said she still has 'this band' (not clarified further) in her neck right now. Patient works in the healthcare. She does cut skin. She took it at her work. Patient did blood test three months ago (Oct2020) at her doctor's office. Outcome of sore arm was not recovered, outcome of body ache was recovering, outcome of other events was unknown. Information on lot number/batch number was requested.
56 2021-01-22 swelling face swelling and blistering of skin around nose, right eye and right cheek. started 4 days after inject... Read more
swelling and blistering of skin around nose, right eye and right cheek. started 4 days after injection and worsened over 4 additional days before seeking medical treatment
56 2021-01-22 swelling Vaccine given at 7:30 am no symptoms until 7pm when temp started to climb, by 11pm temp was 104.5 ... Read more
Vaccine given at 7:30 am no symptoms until 7pm when temp started to climb, by 11pm temp was 104.5 despite Tylenol and ibuprophen. I also experienced joint pain and swelling over entire body. These were the same symptoms I had to an antibiotic years ago. The doctors referred to it as serum sickness.
56 2021-01-23 swelling fell down on Thursday and got vaccine on Friday, Had swelling and resolved now with purple area larg... Read more
fell down on Thursday and got vaccine on Friday, Had swelling and resolved now with purple area large where swelling was and migrating to feet and experiencing dizziness, heart is racing; gasping for air over phone but able to speak a complete sentences
56 2021-01-24 lymph node swelling Tachycardia pulse 130's, palpation, lymph node swelling, brain fog ( difficulties concentration)
56 2021-01-24 lymph node swelling Swollen throat glands + sore throat, beginning January 1, 2021 through January 7, 2021. Stiff and s... Read more
Swollen throat glands + sore throat, beginning January 1, 2021 through January 7, 2021. Stiff and sore right shoulder and neck (muscular and joint pain), mid-January through present. Multiple Canker Sores on lower lip, January 22 through present.
56 2021-01-24 swelling face face swelling and pain where I had dermal fillers put in in August 2020. Started with upper lip on ... Read more
face swelling and pain where I had dermal fillers put in in August 2020. Started with upper lip on 1/22/21 and then my eyes were swollen, bruised and painful upon waking 1/23/21 and lasted until early morning of 1/25/21. My whole face was sore to touch during this time. I also had fatigue and headache starting 1/21/21 which lasted a few days along with fever, chills, body aches and sore left armpit which started early morning 1/22/21. I had expected these last symptoms so was not alarmed. I was not warned about the facial swelling and that was a bit scary.
56 2021-01-25 lymph node swelling, swollen extremities Chills 1/23 Swollen lymph nodes in axillary of arm vaccine was administered
56 2021-01-25 swelling FATIGUE ON DAY OF VACCINE. SYMPTOMS SET IN AROUND 9:30 PM ON 1/19 - CHILLS, SWELLING, MILD HEADACHE,... Read more
FATIGUE ON DAY OF VACCINE. SYMPTOMS SET IN AROUND 9:30 PM ON 1/19 - CHILLS, SWELLING, MILD HEADACHE, EXTREME FATIGUE; FOGGINESS AND FEVERISH. SYMPTOMS BECAME MILDER AOUND 8PM ON 1/20 - TEHN OVERHEATED BUT CLEARERE. GRADUALLY GETTING BACK TO NORMAL TODAY 1/21. VERY DEHYDRATED. TOOK ADVIL. DRANK LOTS OF FLUIDS
56 2021-01-27 lymph node pain Body aches, Tenderness under right arm - lymph node association, mid to lower back pain,
56 2021-01-27 lymph node pain Tenderness under arm, - lymph node association, mid to lower back, site swelling Ibuprofen 400 mg ... Read more
Tenderness under arm, - lymph node association, mid to lower back, site swelling Ibuprofen 400 mg relieved symptoms
56 2021-01-27 peripheral swelling Swollen, Large Red whelp with hard knot inside arm. Burning and itching sensation. Ibuprofen and i... Read more
Swollen, Large Red whelp with hard knot inside arm. Burning and itching sensation. Ibuprofen and ice packs did not improve area.
56 2021-01-27 swelling face Experienced warm feeling, nausea and itching of lips within 10 minutes of administration. After app... Read more
Experienced warm feeling, nausea and itching of lips within 10 minutes of administration. After approximately 40 minutes noted itching in throat. Returned to vaccination area approximately 60 minutes after injection for guidance and instructed to ED. Noticed lip swelling and facial swelling later in ED, had mask on entire duration, did not note when first occurred. Lip itching, throat itching relieved with Benadryl, prednisone and pepcid all given po, released to home after 4 hours observation. Throat itching persists on day 2, some relief with benadryl Q 4 hours.
56 2021-01-27 swelling face I had facial swelling where my eyes were almost swollen shut and violent diarrhea.
56 2021-01-27 swelling face Face, neck, arms turned bright red; Face extremely swollen; Nausea; This is a spontaneous report fro... Read more
Face, neck, arms turned bright red; Face extremely swollen; Nausea; This is a spontaneous report from a contactable healthcare professional. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), intramuscular (left arm) on 12Jan2021 10:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included lamotrigine. The patient experienced Face, neck, arms turned bright red, Face extremely swollen, Nausea; all on 12Jan2021 10:45 AM. The outcome of the events was recovering.
56 2021-01-28 swelling face I feel ok during the observation period, after I left I felt pain on my face and numbness and tingli... Read more
I feel ok during the observation period, after I left I felt pain on my face and numbness and tingling. My face was swollen on the left side and my head on the left side hurt. I took some tylenol and went to bed. I had body aches. The body aches went away after the third day. Only my face hurt and it was kinda swollen. I called my doctor on the 5th day and he prescribed Gabapentin. The pain increased more and more each day.
56 2021-01-29 lymph node swelling Headache fatigue chill fever nausea diarrhea lymph node swelling. Pain itchiness
56 2021-01-29 swelling face, peripheral swelling Numbness tingling in bilateral hands and feet at 4 1/2 hours post vaccine then swelling of hands fa... Read more
Numbness tingling in bilateral hands and feet at 4 1/2 hours post vaccine then swelling of hands face lips and tongue. At 6 hrs post vaccine. Core temperature below 95. Severe headache , lightheaded dizziness at 4 1/2 post vaccine Severe muscle weakness and pain start at 8 hrs post vaccine . All symptoms last 48 hrs post vaccine Took aspirin, ibuprofen and Benadryl
56 2021-01-31 swelling Pt reported swelling (now improving) of her cosmetic fillers. This has been reported with Moderna's ... Read more
Pt reported swelling (now improving) of her cosmetic fillers. This has been reported with Moderna's vaccine but not yet with Pfizer's to my knowledge.
56 2021-02-01 lymph node swelling Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; Shi... Read more
Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; rash; right inguinal large tender lymphadenopathy appeared same time; fatigue; muscle aches; This is a spontaneous report from a contactable nurse reporting for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) via an unspecified route of administration on 12Jan2021 14:00 at single dose in left arm for COVID19 immunisation. Patient age at time of vaccination was 56 Years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) administered on 22Dec2020 at 14:00 in left arm. The patient has allergies to Duricef, milk, almonds. Prior to vaccination, the patient was diagnosed with COVID-19. The patient received unspecified concomitant medications. On 13Jan2021 the patient experienced Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; rash appeared 18 hours after 2nd Covid vaccine; right inguinal large tender lymphadenopathy appeared same time; also had normal fatigue, muscle aches from vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. As treatment for the events the patient received Acyclovir 800 mg QID x 7 days and terrasil ointment. The events were reported as non serious. Since the vaccination, the patient has not been tested for COVID-19. The events had not resolved.
56 2021-02-01 swelling left armpit and under arm became swollen and tender to the touch; left armpit and under arm became s... Read more
left armpit and under arm became swollen and tender to the touch; left armpit and under arm became swollen and tender to the touch; arm remained somewhat sensitive to the touch; Patient was also extremely tired; This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL1284, on 06Jan2021 09:30 Intramuscular at single dose in left arm for COVID-19 immunization. Medical history included Anxiety and depression, Chronic pain in right foot, tendinopathy of right foot since 2015, Derangement of medial meniscus, Environmental allergies, Fatty liver H/O, hypothyroidism since 25Jan2013, Health care maintenance, Hyperlipidemia since May2016, thyroid nodule since 25Jan2013, Obesity, Prediabetes. Concomitant medications included salbutamol (ALBUTEROL), levothyroxine and omeprazole. The patient previously received first dose of BNT162B2 lot number=EH9899 on 16Dec2020 11:00 AM via Intramuscular at left arm at 56-year-old. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately 24 hours after receiving the vaccine, left armpit and under arm became swollen and tender to the touch on 07Jan2021 08:00. Notified primary care physician during routine visit, PCP advised to notify her if symptoms did not resolve. Swelling resolved 4 days after onset, arm remained somewhat sensitive to the touch. Patient was also extremely tired for 2 days after the vaccine but otherwise fine. No treatment was received for all events. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The outcome of all events was resolved.
56 2021-02-02 anaphylactic reaction Anaphylaxis: abrupt throat swelling, shortness of breath, facial redness, GI distress
56 2021-02-02 lymph node swelling Headache Fever, achy,redness at injection site, swollen lymp nodes, itching Narrative:
56 2021-02-02 lymph node swelling Very enlarged lymph nodes in left axilla size of a grapefruit
56 2021-02-04 anaphylactic reaction patient had an anaphylactic reaction to the second dose of covid vaccine and was given 2 Benadryl an... Read more
patient had an anaphylactic reaction to the second dose of covid vaccine and was given 2 Benadryl and 2 doses of epi pen before being take by EMS to hospital
56 2021-02-06 swelling face, swelling, peripheral swelling Awoke at 414am with itching scalp, palms, eyelids, skin folds (neck, elbows, knees, hips), welts, sw... Read more
Awoke at 414am with itching scalp, palms, eyelids, skin folds (neck, elbows, knees, hips), welts, swelling in eyes, hands, face, neck.
56 2021-02-07 c-reactive protein increased Post vaccine day 1 (after 2nd dose) Was at work, began feeling very poorly in the late afternoon - w... Read more
Post vaccine day 1 (after 2nd dose) Was at work, began feeling very poorly in the late afternoon - went home & went to bed, slept through night and had sweats on and off. Post vaccine day 2- Fatigue, abdominal discomfort and pressure, constipated. Nausea and vomiting developed, with dehydration. Constipated, symptoms consistent with Crohn's flare. Went to ER but due to long wait was not seen by physician. Gradually improved, saw GI specialist day 4, felt much better by day 6. Bowels not quite back to normal 2 weeks later
56 2021-02-07 swollen extremities, lymph node pain Woke up Saturday morning with soreness and swelling in right armpit. Bothersome. Ended up taking ibu... Read more
Woke up Saturday morning with soreness and swelling in right armpit. Bothersome. Ended up taking ibuprofen and Tylenol in the afternoon. Seemed to relieve soreness. Today just a little sore. Swelling seems to have gone away.
56 2021-02-07 swelling complaint of increased swelling, pain and redness at injection site and circumference of left are 3 ... Read more
complaint of increased swelling, pain and redness at injection site and circumference of left are 3 days after second COVID injection right deltoid are measure 18.5inches Left deltoid measured 20 inches with hardness and redness
56 2021-02-09 anaphylactic reaction Patient had anaphylactic reaction to vaccine and was given #2 Benadryl and #2 doses of Epi-Pen befor... Read more
Patient had anaphylactic reaction to vaccine and was given #2 Benadryl and #2 doses of Epi-Pen before being taken to hospital by EMS.
56 2021-02-09 swelling Hot painful red rash on abdominal area; Hot painful red rash on abdominal area; welts; swelling; Thi... Read more
Hot painful red rash on abdominal area; Hot painful red rash on abdominal area; welts; swelling; This is a spontaneous report from a contactable other hcp. A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration at single dose left arm on 23Jan2021 11:15 for covid-19 immunisation. Medical history included thyroid disorder, breast cancer female, migraine, allergy to sulfonamide and topamax, food allergy. Concomitant medications included levothyroxine, liothyronine (NP THYROID), multivitamin, plant based calci. The patient experienced hot painful red rash on abdominal area on 23Jan2021 18:00, welts on 23Jan2021 18:00, swelling on 23Jan2021 18:00. No treatment received. The outcome was not recovered. Information on the lot/batch number has been requested
56 2021-02-10 c-reactive protein increased Sob, low grade fever, bodyaches initially. Then persistent low grade fever, elevated liver GGT, ALT... Read more
Sob, low grade fever, bodyaches initially. Then persistent low grade fever, elevated liver GGT, ALT, AST, CRP nonhs, mild changes wbc diff, mild hepto and splenomegaly,
56 2021-02-10 lymph node swelling While waiting the 15 minutes after vaccine, after 8 minutes, my body got very hot, clammy, sweating,... Read more
While waiting the 15 minutes after vaccine, after 8 minutes, my body got very hot, clammy, sweating, and about to pass out. Nurse took my oxygen levels and heart rate, below 40. Blood pressure very low. Called 911. Put oxygen on me, gave me Epipen, and checked sugar levels. Next heart rate, a few minutes after first one, 40 heart beats and blood pressure coming back up. Gave me water and orange juice. Next check, heart rate up to 88 and blood pressure they said was getting back to normal but don't remember numbers. I was still trying to feel back to myself after a half hour to 45 minutes. My doctor says not to get 2nd dose in which I'm due on 2/21/2021. I started to feel back to myself around an hour later. I did not go to hospital due to me feeling better. After shot, regular symptoms, sore arm, fatigued, lymph nodes felt swollen, and sniffles and sneezing. No fever. I called my physician on 2-1-2021 to let her know what happened.
56 2021-02-11 anaphylactic reaction Anaphylaxis, itching, tightness of the throat, shortness of breath, low oxygen levels Treatment: 1... Read more
Anaphylaxis, itching, tightness of the throat, shortness of breath, low oxygen levels Treatment: 1 Benadryl 1130am, 1 Epipen 1155am, 1 Epipen 1225, steroids intravenously 1pm Outcome: Released home
56 2021-02-11 peripheral swelling 1/25 L sore shoulder. 1/26 L sore shoulder. 1/27 L burning sensation running down arm from shoulder... Read more
1/25 L sore shoulder. 1/26 L sore shoulder. 1/27 L burning sensation running down arm from shoulder to wrist. 1/28 L forearm and wrist began to swell and be very painful, complete loss of all wrist range of motion this continued thru Monday 2/8 This was so painful that I sought medical treatment from a MUSC health, Lanc MD on 2/5. He examined my wrist and sent me for an X-ray, X-ray was negetaive. Monday 2/8 the pain was subsiding from my wrist and began to start in my L shoulder. Wed 2/10 The pain had moved under my breast radiating from my L front around my back, severe along with shortness of breath. I went to ER for a complete work up including a CT to rule out a blood clot. All test negative all blood work normal. Except it did reveal that I had a UTI. I have never had a UTI in my life. I was started on a anitibiotic for the UTI. I still have the pain under my L breast. Unknown reason.
56 2021-02-11 white blood cell count increased I received my vaccine at 6:55am on 12/30/2020. I waited about 20minutes in the observation area. I f... Read more
I received my vaccine at 6:55am on 12/30/2020. I waited about 20minutes in the observation area. I felt fine and went to work. It was a normal day of rooming patients, I had lunch of yogurt and blueberries about 2 pm I started feeling very hot and "off". I went to the front of the office and checked my temp which was normal. As I walked down the hall to the back of the office I started feeling very nauseous, dizzy and my legs felt like jello. I sat down in my chair and got more dizzy so I put my head in my hands. The other MAs were asking me if I was ok but I couldn't think of the words and then I couldn't get the words out for about 10 seconds. When I did arouse again I was told I was slow to answer questions after
56 2021-02-12 oral herpes Arm, shoulder, neck soreness and extreme sensitivity to touch. Can wear a bra because of the sournes... Read more
Arm, shoulder, neck soreness and extreme sensitivity to touch. Can wear a bra because of the sourness. I also have a small area under the clavicle where there is a lump that also is extremely sensitive to touch. I developed a cold sore (herpes) on my chin. This is an area I've never had an outbreak on. This is still the case 4 days later.
56 2021-02-14 swelling Angioedema extending from the right side lower lip back to my ear and under my jaw on the right side... Read more
Angioedema extending from the right side lower lip back to my ear and under my jaw on the right side/Doctor's diagnosis was angioedema secondary to vaccination; This is a spontaneous report from a contactable Other HCP (patient). This 56-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL1283) at single dose on 22Jan2021 09:00 in left arm for COVID-19 immunisation. The first dose (Lot#: EK9231) was received on 04Jan2021 at 02:30 PM in left arm. Medical history included known allergies to penicillin. Patient also had known allergies to cefalexin monohydrate (KEFLEX) in the past. There was no other medications in two weeks. There was no other vaccine in four weeks. There was no covid prior vaccination, no covid tested post vaccination. Patient experienced angioedema extending from the right side lower lip back to my ear and under my jaw on the right side on 25Jan2021 at 03:00 AM. It resulted in emergency room (ER)/department or urgent care and treatment included epinephrine, steroids, and diphenhydramine hydrochloride (BENADRYL). She went to ER due to side effect of the vaccine - Doctor's diagnosis was angioedema secondary to vaccination. The outcome of event was resolved in Jan2021.; Sender's Comments: Based on the compatible time association and drug's safe profile, the angioedema is possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
56 2021-02-14 swelling face Numbness lower face; swelling lower face and tongue; lump in throat (throat closing); extreme thirst
56 2021-02-14 swelling face 1/21/2021- First Dose- Following day mild muscle soreness at site, ongoing fatigue, never feels res... Read more
1/21/2021- First Dose- Following day mild muscle soreness at site, ongoing fatigue, never feels rested or wants/needs to sleep, a lot. Noticed abdominal pain, but did not connect the two. 2/11/2021- 2nd dose- Two hours later (approx) moderate pain at site, my head/mind felt "off", out of sync like one side of brain slower, affected balance. It was strange, and unpleasant. 2/12/2021- Groggy, face/eyes swollen, did not feel well, but not so bad I could not go to work. It was a 50 mile drive, and as I drove the same feeling of not thinking straight did not want to drive. The feeling of being unwell escalated quickly. Congestion, muscle aches throughout, sore throat, chills, and a need to catch my breath caused dizziness. I pulled over, called work, and made my way home where I went directly to bed. My head ached, abdominal (sharp) pains, especially after ingesting fluids. or food similar to gall bladder pain, but not close to its worse intensity still, continues. 2/15/2021- Update- Nearly 96 hrs. passed: What remains is: Feeling exhausted, need to sleep, more frequent and intensifying abdominal pains, headaches, pain in left lung/easily winded, and site pain expansion. Injection arm (left) pins & needles, and fingers ice cold, neck pain (stiffness).
56 2021-02-15 lymph node swelling 1/7/21 arm soreness overnight, 10 AM 1/8/21 next morning pt noticed pulse was about 135 resting, pt... Read more
1/7/21 arm soreness overnight, 10 AM 1/8/21 next morning pt noticed pulse was about 135 resting, pt went to work and felt out of it, overall unwell feeling, went to walk in clinic, blood pressure was high even after meds, EKG showed tachycardia but normal rhythm, pt went home went to bed at 2 PM slept until next morning, 1/9/21 fatigue, swollen lymph node under left arm, small lymph node in neck also swollen, headaches, flushed/grey looking, as of 2/16/21 pt is feeling much better
56 2021-02-19 peripheral swelling The area is swollen with redness, soreness and itches sometime. It Underarm area sore. Yesterday I b... Read more
The area is swollen with redness, soreness and itches sometime. It Underarm area sore. Yesterday I began rubbing alcohol on the area. I hope this is common and will disappear soon.
56 2021-02-21 oral herpes, swelling face The doctor offer me some ointment for the cold sore but I am using something so I declined. Told me... Read more
The doctor offer me some ointment for the cold sore but I am using something so I declined. Told me to take NSAID for bump under my chin. I forgot to tell her about the pain in my left rib area.
56 2021-02-22 lymph node swelling fairly severe, headache, lymph node swell
56 2021-02-23 swelling sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft pala... Read more
sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; scratchy throat on eating red meat, milk, or cheese; muscle and joint pain; earache; pain was all over; muscle and joint pain; headache; exhaustion; pain at injection site; slight fever; mild nausea; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264), on right arm via an unknown route of administration on 03Feb2021 13:45 for COVID-19 immunization. Medical history included VonWillebrand's and history of lyme disease. The patient had allergy to peanut and allergy to latex. Concomitant medications included unspecified vitamin supplements. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302) on Left arm, on 13Jan2021 13:30 for COVID-19 immunization. Patient stated, "After first shot in left arm, only on her left side she had: Muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered. Second shot in right arm: Same as above (muscle and joint pain, earache, headache, exhaustion, and pain at injection site), although no eye drainage and pain was all over with slight fever, mild nausea in Feb2021. Lasted from 12 hours to 36 hours after the test. Arm remained sore longer, but not problematic. Bizarre possible response: 6 days after second shot on 09Feb2021 17:30, the patient experienced sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes, scratchy throat on eating red meat, milk, or cheese. Patient did not need epi-pen but needed double dose of benadryl. Events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Benadryl and epi-pen on hand was received as treatment for events. The events were assessed as non-serious by the reporter. Outcome of events muscle and joint pain, earache, headache, exhaustion, pain at injection site, pain was all over, slight fever, mild nausea was recovered in Feb2021, whereas outcome for other events was reported as unknown. No follow-up attempts are possible. No further information is expected.
56 2021-02-24 peripheral swelling Informed would like to discuss her reaction to the Covid vaccine. States received the vaccine 12/21... Read more
Informed would like to discuss her reaction to the Covid vaccine. States received the vaccine 12/21 at 10:15 a.m. Approx 1500 - 1600 , the same day the injection site had "normal soreness, like a flu shot". On 12/22 woke up around 7 a.m. and couldn't move the affected arm due to pain. Reports it hurt to move her fingers. Temp was 99.5, maximum. The upper arm was swollen. On 12/23, temp is 97.6. Feels "normal soreness, like a flu shot
56 2021-02-24 peripheral swelling Covid fingers - left ring finger swollen and black and blue (with a bump) - from base of the finger ... Read more
Covid fingers - left ring finger swollen and black and blue (with a bump) - from base of the finger to the joint as of 4pm on 2/24. On 2/25 in the morning the black and blue has extended beyond the knuckle toward the end of the finger but only about 1/4" beyond the knuckle. Right hand, middle finger, black and blue between the knuckle nearest the hand and the knuckle nearest the finger tip. No swelling. This was noticed about 9pm on 2/24. Covid Toes - possibly - red bumps on toes same toe, both feet, red. Toes next to pinky toe.
56 2021-02-25 lymph node swelling Vaccine received at approximately 1010 on 1/11/21. I felt fine...just some soreness at the injectio... Read more
Vaccine received at approximately 1010 on 1/11/21. I felt fine...just some soreness at the injection site. Overnite, intense HA noted that slightly subsided after 400mg ibuprofen, completely subsided by end of day 1/12/21. Body aches, malaise and a feeling that my left axillary lymph nodes were enlarged. All of these symptoms were at the worst in the middle of the night but all pretty much subsided by eve of 1/12/21.
56 2021-02-25 swelling Rash on upper thighs, abdomen/stomach and crease of arms. Noticed the morning after injection light ... Read more
Rash on upper thighs, abdomen/stomach and crease of arms. Noticed the morning after injection light red, slightly raised. Doesn't really bother me. No itching, burning or problems breathing. Took a Claritin and worked on 2/25. When I got home from work on2/25 showered and took a Benadryl. Rash is still here this morning. On my arms it is much lighter but still the same everywhere else.
56 2021-02-28 peripheral swelling I noticed on my forearm red spot(bruise under the skin),swelling right arm and into hand. The swelli... Read more
I noticed on my forearm red spot(bruise under the skin),swelling right arm and into hand. The swelling lasted for about a week and the spot faded after time.
56 2021-02-28 swelling Pt described a difficulty swallowing, slight swelling, and a brief time of altered mental status abo... Read more
Pt described a difficulty swallowing, slight swelling, and a brief time of altered mental status about 30 minutes after vaccine administration. Pt was able to calm down and described a slight alleviation in symptoms. Pt denied hx of anaphylaxis. Medics were dispatched to the location to transport. No medications given by health department or EMS on scene.
56 2021-03-01 oral herpes On February 14, five days after second Covid shot, patient woke up with ulcer in corner of left eye ... Read more
On February 14, five days after second Covid shot, patient woke up with ulcer in corner of left eye and growing pain in eye itself. Eye was watering and red and very painful. Symptoms persisted. On February 24, patient went to Urgent Care who found ulcerations on cornea and referred to ophthalmologist, Dr., who suspected herpes sores, perhaps due to an immune system reaction to the second Covid shot. Treated with eye drops (Moxifloxacin, 0.5% 4 times daily), and oral antiviral (Valaclyclovir HCL, 500 mg 2 tablets three times daily). Eye is MUCH improved, but the ulceration has not entirely disappeared. It is to be hoped that completing the Moxifloxacin and Valclyclavir regimen will completely clear the damage, but there is some concern that there may be permanent scarring. A fourth examination is scheduled for March 10.
56 2021-03-01 swelling Within 12 hours I had extreme fatigue, extreme muscle/body ache, chills, brain fog. This lasted for ... Read more
Within 12 hours I had extreme fatigue, extreme muscle/body ache, chills, brain fog. This lasted for about 48 hours. After 48 hours the rash started on top on both ankles. That lasted probably 8 days and didn't get better with cream. The muscle aches started in my neck and upper body and about 11days ago decided to settle in my knee (right). I though I maybe slipped or fell but didn't because of the pain. The pain is cross between a cramping muscle and shin pain. I've been walking with a limp. I got in yesterday with my PCP and sending me for an ultrasound to rule out a blood cot. He doesn't believe it is because it moves, I don't have any swelling or redness. I have just been really fatigue. I had BP done to make sure my Thyroid is ok and it is. The past 3 nights it has stopped waking me up at night. I've been doing epsilon salt baths, I can't put weight on it and still walk with a limp. I go for ultrasound tomorrow.
56 2021-03-02 lymph node swelling 12/18 1st vaccination 12/27 COVID + 1/10 2nd vaccination Later that evening, I had tightness on R s... Read more
12/18 1st vaccination 12/27 COVID + 1/10 2nd vaccination Later that evening, I had tightness on R side chest. Rapid HR. Pulse 144. Lasted 3-4 minutes. Called 911. HR had gone back down to 78, normal BP, normal EKG. Tachycardia 1/11 lymph nodes swollen under armpit on R side. Sore arm. Had another episode 2 days later; Tachycardia. Went to Dr 1/13/2021. Full work up. Started on BP medicine.
56 2021-03-02 lymph node swelling Lymphadenopathy Very swollen, sore and red lymph nodes on the left side of the neck
56 2021-03-02 lymph node swelling VOMITING for two days after shot and ondansetron prescribed, SWOLLEN GLANDS ON LEFT SIDE NECK AND CL... Read more
VOMITING for two days after shot and ondansetron prescribed, SWOLLEN GLANDS ON LEFT SIDE NECK AND CLAVICAL AREA, NUMBNESS IN HANDS AND FINGERS, RAISED BLOOD PRESSURE, 103F FEVER on DAY AFTER SHOT
56 2021-03-04 axillary mass Initially ( on the night of 2-26-2021 while taking a shower), I noticed a lump under my left armpit.... Read more
Initially ( on the night of 2-26-2021 while taking a shower), I noticed a lump under my left armpit. It was slightly swollen and sore/painful to the touch...after about 3 to 4 days this subsided. On Monday ( March 1, 20201) until the present I have had intense pain at the nap on my neck -it is a stiffness and tightness. It is intermittent and can only be relieved with ibuprofen
56 2021-03-06 swelling face Vaccine at 6:00 PM Thursday, 3/4/21, symptoms started Friday afternoon 3/5/21 (About 20 hours after... Read more
Vaccine at 6:00 PM Thursday, 3/4/21, symptoms started Friday afternoon 3/5/21 (About 20 hours after vaccine) my cheeks and eyelids became slightly red and felt irritated and felt like a bad sunburn.. Woke up on Saturday 3/6/21 at 8:00AM and the left side of my face and eye was swollen and red rash covered most of cheeks on both sides and well an the entire eyelids on both eyes as well as my far head. Was very painful and felt like a bad burn. Went to Urgent Care and was prescribed over the counter products and said rash is most likely a related to Covid Vaccine and to report it to VAERS. As of 6:45 PM on 3/7/21 as I am filling this out my face is still the same as it was Saturday still red in the same places and still sore.
56 2021-03-07 lymph node swelling, lymph node pain EXTREME SWELLING OF LEFT LYMPH NODE WITH PAIN.
56 2021-03-07 lymph node swelling, lymph node pain Swollen tender lymph nodes on back of neck
56 2021-03-07 lymph node swelling sharp, unremitting R axillary pain; lymphadenopathy/swelling; This is a spontaneous report from a co... Read more
sharp, unremitting R axillary pain; lymphadenopathy/swelling; This is a spontaneous report from a contactable physician, reporting for herself. A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269), intramuscularly at the right deltoid on 04Feb2021 12:30 at a single dose for COVID-19 immunization. Vaccination was done in a Public Health Department. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no other medications received within 2 weeks of vaccination. There were no known drug allergies. The patient previously received fist dose of BNT162B2 (lot number: EL3246), intramuscularly at the right arm on 14Jan2021 14:30 for COVID-19 immunization. On 05Feb2021 22:00, the patient developed sharp, unremitting right axillary pain and lymphadenopathy. She had a normal mammogram earlier this year and no injuries or other reasons to suspect this pain and swelling was due to anything other than a reaction to the 2nd COVID-19 vax. The patient was not worried nor upset, just wanted to pass along this information. No treatment was received. The outcome of the events was not recovered.
56 2021-03-07 lymph node swelling Swollen lymph nodes in the right side of neck
56 2021-03-08 lymph node swelling On March 1 2021, day of vacinne arm was achy. Then Tuesday afternoon eyes started itching. By 7:30pm... Read more
On March 1 2021, day of vacinne arm was achy. Then Tuesday afternoon eyes started itching. By 7:30pm my left eyes was bloodshot. Really, really red. I put some over the counter eye drops in both eyes on Tuesday night and Wed every 4 hours. Redness subsided 24 hours later, but eyes were still itchy. They Thursday night my left gland started swelling. On Friday it was very swollen. I could cup my hand around the swelling from check to neck. It hurt to swallow. I took my temperature every few hours and it was never elevated. It was always normal . I took an ibuprofen, 800 mg and just relaxed around 5:00 pm. Still swollen on Saturday, but going down, Took another 800. mg of ibuprofen Saturday night around 8:00 pm and swelling continues to go down, but still swollen as of Tuesday, March 9, my birthday. I did receive my Tetanus shot, preventative on February 15, 2021.
56 2021-03-09 lymph node swelling Lymphadenopathy in the glands of the armpit were the first and second shot were given; Strong headac... Read more
Lymphadenopathy in the glands of the armpit were the first and second shot were given; Strong headache; Mild tiredness; chills; low fever; This is a spontaneous report from a contactable Consumer. A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 (Lot Number: EW 5318) via an unspecified route of administration at SINGLE DOSE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL 3248) on 13Jan2021 without expected adverse event (arm pain and tiredness). The patient had lymphadenopathy in the glands of the armpit were the first and second shot were given on 05Feb2021. Strong headache (not improving with Acetaminophen 500 mg on 04Feb2021, Mild tiredness, chills and low fever on 03Feb2021. The patient started Tylenol for the common symptoms expected after the shot that day (as recommended by the vaccination center). Tiredness started that day. The strong headache started late afternoon of 04Feb2021 (less than 24 hrs. from reporting). On 05Feb2021 around 8:00 the armpit swollen. There was not a sudden but a progression of symptoms. The patient didn't report the events aware that are common from vaccination, and reported (1 hour, 25 minutes) about the armpit swollen. The patient stated that the tiredness was indicated as a common effect so not report it Tylenol was recommended. The strong headache started late on 04Feb2021 and the armpit swollen the day after 05Feb2021 (Early in the morning). The patient took rest on the weekend and changed from Tylenol to Naproxen. Headache and swollen armpit (left side where the shot was given) disappeared. Feeling well since yesterday (currently without medication). The outcome of the event strong headache and Lymphadenopathy in the glands of the armpit were the first and second shot were given was recovered and outcome of all other events was unknown. No follow-up attempts are possible. No further information is expected.
56 2021-03-10 lymph node swelling, swelling initial normal soreness in arm at injection site, followed by fatigue and flulike symptoms going on ... Read more
initial normal soreness in arm at injection site, followed by fatigue and flulike symptoms going on 14 days now. Some improvement but continue to feel somewhat breathless at times, extreme fatigue (abnormal for me), decreased appetite, muscle aches (severe at times), tightness in my jaw on left side with noticeable jaw clicking that I have never had, and on day 3 woke with severe, noticeable swelling in my left axilla (egg shaped and protruding) and my left neck/jaw -- also seems to be in the lymph node area. Underarm swelling improved but still have a sense of tightness in my neck and jaw.
56 2021-03-10 lymph node swelling Swollen supra clavicle node
56 2021-03-10 lymph node swelling Fatigue Headache Muscle pain Chills Joint pain Low fever Swollen left arm lymph nodes
56 2021-03-10 swelling face, lymph node swelling 03/04/2021- Difficulty breathing and chest tightness, off and on throughout day. 03/05/2021- Face s... Read more
03/04/2021- Difficulty breathing and chest tightness, off and on throughout day. 03/05/2021- Face swelling on the left side and also swollen lymph nodes, symptoms still continue 03/11/2021.
56 2021-03-11 lymph node swelling, lymph node pain Day 2 after the shot I began to feel chills and fatigue. My temperature was 102.2 when I checked it.... Read more
Day 2 after the shot I began to feel chills and fatigue. My temperature was 102.2 when I checked it. Later that same day it had gone up to 102.4. I had no appetite and extreme fatigue. Took Tylenol which lowered the fever. Day 3 my temperature stayed at 102.4 and I had painful, swollen glands along my left clavicle, as well as fatigue. Also, the injection site became hot and swollen. Day 4, my temperature has gone down but I have a terrible headache, swollen clavicle glands and a chain of swollen nodes (?) from the base of my skull down the back of my neck on the right side. My left arm is still hot and swollen at the injection site. I've had to miss two days of work.
56 2021-03-11 swelling Patient presents with generalized swelling/lump left clavicular area which began after receiving sec... Read more
Patient presents with generalized swelling/lump left clavicular area which began after receiving second dose of covid vaccine and persistent at 6 weeks post second dose
56 2021-03-12 swollen extremities I got my second Covid-19 dose on Thursday morning 3/11/2021 at 9:35 am. I was feeling uncomfortable ... Read more
I got my second Covid-19 dose on Thursday morning 3/11/2021 at 9:35 am. I was feeling uncomfortable in my left armpit since Friday 3/12/21 noon, but I only realized it was swollen when I went to take a shower around 8:00 pm. I'm feeling it swollen, burning and mild pain.
56 2021-03-12 peripheral swelling About 2 hours after receiving the vaccine, I became very nauseated. I than begin vomiting. I vomit... Read more
About 2 hours after receiving the vaccine, I became very nauseated. I than begin vomiting. I vomited probably around 7-8 times (maybe more), and the last 2 times there was nothing left in my stomach to come up and I was just heaving. I also had moderately severe lower abdomen cramps (just above my pelvic bone). It felt like my insides were twisting at times, and the pain was constant cramping with moments of pretty severe twisting doubling over pain. I had chills just before the vomiting started, and felt like I had a slight fever, but because of the constant nausea/vomiting I did not take my temperature (all I have is an oral thermometer). To get the pain to stop, I had to lay down on a bed and put pressure on my stomach sides to ease the cramping. I tried taking Pepto-bismol to stop the nausea and vomiting, but immediately vomited that up too. The vomiting finally stopped after 2 times of dry heaving and nothing left to come up. The severe lower abdomen stomach cramping calmed down around 1 or 2 am. Today I feel weak, my right arm is very sore and slightly swollen, and as of the time of this report at 2:30pm I have only eaten some saltine crackers today. My stomach still feels weak, even though the nausea, cramping, and vomiting have gone away now.
56 2021-03-13 lymph node swelling Left Under arm swollen and pain, some pain in arm
56 2021-03-13 peripheral swelling, lymph node swelling Swelling in arm on day 1 and 2, headache for two days, Lymph node swollen Day 3.
56 2021-03-14 lymph node swelling Swollen lymph nodes under arm, small red, dry area on arm, pimple style sores
56 2021-03-15 lymph node pain, lymph node swelling pain in R arm/bicep swollen lymph nodes over right clavicle, with redness and pain on palpation
56 2021-03-15 lymph node swelling I had a swollen lymp node in my left armpit; This is a spontaneous report from a contactable consume... Read more
I had a swollen lymp node in my left armpit; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient reported that first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot# EL9264), via unspecified route of administration on 04Feb2021 13:45 at single dose in the left arm for covid-19 immunization. Medical history included hypertension. Concomitant medications included Lycortin, Norvasc, Carvedilol, Aspirin, Doxycycline. The patient reported as, I had a swollen lymp node in my left armpit on 08Feb2021. Outcome of the event was not recovered.
56 2021-03-15 peripheral swelling Itching started in feet immediately after shot. Weird pain in lower middle back. Itching progresse... Read more
Itching started in feet immediately after shot. Weird pain in lower middle back. Itching progressed to entire body after about an hour. Took 12.5 mg Benadryl, then took 12.5 mg two hours later. Next day arm was swollen and aching, itching continued. Took 625 mg Tylenol Arthritis, 25 mg. Hydroxyzine every 8 hours for two days.
56 2021-03-15 peripheral swelling 2/22/2021 1st Dose: Within 2 hours: severe pain from neck to fingertips on L arm. Lasted approximate... Read more
2/22/2021 1st Dose: Within 2 hours: severe pain from neck to fingertips on L arm. Lasted approximately 4 days. Within 4 hours: severe headache, took 2 500mg Tylenol about 3-4 times over the course of 48 hours. Headache subsided on 3rd day. 3/15/2021 2nd Dose: Within 1 hour: weakness, pain from neck thru fingertips in L arm, throat swelling, came home took 2 Tylenol 500mg gel caps at 4:00pm. Napped until 7:00pm. Temperature was 97.5. Thought I was feeling better. Went to bed at 11:00pm. By 2:30am I was awaking, restless sleep, pain all over body, every joint. Finally got out of bed at 11:30am today. Nerves and joints feel as tho on fire. Both arms and hands very swollen. Toes swollen. Nauseous. No appetite. Hurts to move, sit or lay down. Have rested all day. 6:40pm temperature is 99.8. Feel awful. Shooting pain like electricity down both arms into hands extremely sensitive to cold - feels like fire.
56 2021-03-15 swelling face, peripheral swelling severe swelling of face; including eyes, under eyes, checks. Swollen hands and swollen feet. Went ... Read more
severe swelling of face; including eyes, under eyes, checks. Swollen hands and swollen feet. Went to Hospital Emergency Room. Given IV steriod and benedryl shots. Put on steriod pack and follow up with PCP who recommends I do not get the 2nd shot due to adverse reaction
56 2021-03-17 swelling, lymph node pain, lymph node swelling Chills began 11 hours after shot and continued for 4 hours. Mild fever ( 99.5) began 11 hours after ... Read more
Chills began 11 hours after shot and continued for 4 hours. Mild fever ( 99.5) began 11 hours after shot and continued on and off until 60 hours after the shot. All over body aches and skin sensitivity began 11 hours after the shot and continued for 36 hours and then resolved. Swollen lymph node at left armpit began 11 hours after the shot and was/is uncomfortable and at times painful. Initially the swelling was very pronounced and interfered with arm movement. The swelling has diminished a bit now (75 hours after the shot), but there is still some swelling and occasional pain.
56 2021-03-18 lymph node swelling Large (size of orange) swollen lymph nodes under left arm. Used warm compresses and Advil Still co... Read more
Large (size of orange) swollen lymph nodes under left arm. Used warm compresses and Advil Still continuing as of 03/19/2021 but swelling is lessening.
56 2021-03-18 peripheral swelling "PFIZER COVID 19 VACCINE EUA". Patient received first dose Pfizer vaccine (right deltoid) today at v... Read more
"PFIZER COVID 19 VACCINE EUA". Patient received first dose Pfizer vaccine (right deltoid) today at vaccination site. Due to Pt's hx of moderate allergice reaction to IV iodine during a medical procedure "years ago", pt placed on 30-minute ovservation period. Approx 10 minutes into observation, pt notified staff that she felt some itching on her right arm in crease of elbow. Pt. also saw what she described as bumps or hives the size of a half dollar. Pt moved to private restroom and redness and swelling found progressing behind pt's right knee 5 minutes later. IM Benedryl administered to patient and transport medic unit called. Full report given to transport crew. Pt transported to ED.
56 2021-03-18 swelling face Swollen lip and chin about 12 hours after vaccine; doctor has advised to try Tylenol PM
56 2021-03-19 lymph node swelling Headaches on day 6,7,8 Swollen lymph node on neck ...same side as the injection And still present
56 2021-03-23 anaphylactic reaction Pt received 2nd covid-19 pfizer shot at 3/6/21, pt had anaphylactic reaction within 30min - tongue s... Read more
Pt received 2nd covid-19 pfizer shot at 3/6/21, pt had anaphylactic reaction within 30min - tongue swollen, slurred speech, dysphonia. Was given benadryl, epipen and decadron transferred to ER where she was given additional benadryl and solumedrol and observed. Pt discharged from ER after period of observation.
56 2021-03-23 lymph node swelling Swelling of lymph node under the injection arm. Swelled to size of golf ball and lasted one week. ... Read more
Swelling of lymph node under the injection arm. Swelled to size of golf ball and lasted one week. Fatigue lasted 2 days.
56 2021-03-23 peripheral swelling Swollen & sore arm for 4 days. Gas for 18-20 hrs. Nausea for 2 wks. Headache on left side is still o... Read more
Swollen & sore arm for 4 days. Gas for 18-20 hrs. Nausea for 2 wks. Headache on left side is still occurring.
56 2021-03-24 lymph node swelling After my first dose Pfizer vaccine, I developed enlarged lymph nodes found in a calcium scan. I unde... Read more
After my first dose Pfizer vaccine, I developed enlarged lymph nodes found in a calcium scan. I underwent CT scan, mammogram and ultrasound of the axilla. They thought it could be breast cancer or lymphoma. Today my lymph noes are still present.
56 2021-03-24 lymph node swelling Pt received 1st dose COVID vaccine on 2/24/21. When she returned for 2nd dose on 3/17/21, reported t... Read more
Pt received 1st dose COVID vaccine on 2/24/21. When she returned for 2nd dose on 3/17/21, reported that she had "fatigue for 3 days afterward, but also worked long hours those 3 days". Reported "swollen glands in throat and neck" on the 3rd day "that lasted about 8 hours". Reported "she could breathe fine through nose" and denied any other difficulties breathing. Stated her grandson "said she didn't sound right when she was sleeping" but pt denied any difficulty breathing or sleeping. Denied any rash, itching, or other s/s allergic ran/anaphylaxis. Did not seek medical care.
56 2021-03-25 swelling face Burning in center of chest that led to tightness in chest and a dry cough. Swelling of face and sore... Read more
Burning in center of chest that led to tightness in chest and a dry cough. Swelling of face and sore throat
56 2021-03-26 lymph node swelling Fever, chills, shaking, body aches, and underarm lymph nodes swelled more
56 2021-03-27 peripheral swelling Swollen under arm swelling and painful Same arm as the injection site began 24 hours after receiving... Read more
Swollen under arm swelling and painful Same arm as the injection site began 24 hours after receiving vaccination (3/21/21) stopped (3/23/2021)
56 2021-03-27 swelling face Woke up at 6{00 am the next morning with a left swollen cheek, swollen tongue and a left stiff neck.... Read more
Woke up at 6{00 am the next morning with a left swollen cheek, swollen tongue and a left stiff neck. I took half of a Zytec antihistamine, one Advil and drank extra water. Applied an ice pack. Stiff neck stopped at 36 hours. Swollen tongue stopped at 48 hours. Left cheek swelling went down by 50 % at 72 hours.
56 2021-03-27 swelling, peripheral swelling Sarcoidosis was in remission. I am now in full blown flare with severe joint pain and stiffness, swe... Read more
Sarcoidosis was in remission. I am now in full blown flare with severe joint pain and stiffness, swelling, redness. Extremity swelling. Coughing and chest pain. Extreme fatigue. Today, the pain is so bad I am on the couch. Doctors visit tomorrow
56 2021-03-28 lymph node swelling, lymph node pain 24 hrs after vaccine red hot swollen >5cm area at injection site, severe body aches, head ache, and ... Read more
24 hrs after vaccine red hot swollen >5cm area at injection site, severe body aches, head ache, and chills, 75hrs from vaccine swollen axillary lymph nodes (same arm as vaccine) >10cm in diameter, very painful with pressure on the inside of the left arm extending to the elbow.
56 2021-03-28 swelling 3/26/2021 - Approximately 20 minutes after the injection I started having tingling in my right hand.... Read more
3/26/2021 - Approximately 20 minutes after the injection I started having tingling in my right hand. Same side as injection. I started having tingling and itchy gums itchy throat and itchy ears. My throat swelled up on both sides. All of the above in mild form. I was still sitting in my car in the parking lot & remained there for an additional 30 minutes to make sure it did not get worse. I subsequently ate lunch and continued with my day. Around 9:45pm I went to bed and found that when I would lie down I experienced increased difficulty in swallowing as neck was still swollen both sides under ears and around jaw line. At 10:00pm I took 1 single 25mg Benadryl tablet. Swelling subsided noticeably within 20 minutes. The following day (3/27/2021) much improved with only slight swelling on the left side of my throat under my left ear and along jaw line. Right arm sore from shoulder down to my wrist. By the end of the day my arm was no longer sore. Left side of my throat was still slightly swollen. At bedtime I took 1/2 of a 25 mg Benadryl tablet. Felt fine on Sunday however i still feel as if i have slight swelling
56 2021-03-28 swelling Fever 100.4, severe headache, diarrhea, nausea, lack of appetite...fever lasted 36 hours then droppe... Read more
Fever 100.4, severe headache, diarrhea, nausea, lack of appetite...fever lasted 36 hours then dropped to 97.3...symptoms severe missed 5 days of work...brain felt like it was swollen, also felt dizzy...started feeling like able to do daily routine on Saturday 3/27...but still weak and tire easily. Also, since this..my poop looks yellowish and floats every time. To be honest I am afraid of getting the 2nd vaccine.
56 2021-03-29 fluid retention, swelling face Patient had swelling of her face five days after the vaccine and fluid accumulated under her eyes. ... Read more
Patient had swelling of her face five days after the vaccine and fluid accumulated under her eyes. This lasted for 3 days and she took Benadryl to make the symptoms bearable.
56 2021-03-29 lymph node swelling Rash on face, still here after 3 weeks; day after was tired, nauseated, muscle and joint paint, swol... Read more
Rash on face, still here after 3 weeks; day after was tired, nauseated, muscle and joint paint, swollen lymph nodes, that has resolved itself
56 2021-03-29 lymph node swelling Headache, tiredness, lump under my right armpit
56 2021-03-29 swelling face two hours after vaccination I experienced injection site felt like it was hit with a bat, tired, diz... Read more
two hours after vaccination I experienced injection site felt like it was hit with a bat, tired, dizzy, headache, muscles and joint pain every where like I had the flu, chills, nausea, face and throat swollen and knots on throat, my mouth had sores on my gums, I had a cough and had to take medication for that, sore throat, my fever was up and down.
56 2021-03-29 swelling face I had the Pfizer vaccine for Covid. My neck started to break out in hives on my neck around 45 min ... Read more
I had the Pfizer vaccine for Covid. My neck started to break out in hives on my neck around 45 min after the shot. Then my face started to turn red and swell up. I then started to have more urticaria hives on my face. I went to the Urgency room and they gave me a epinephrine shot, steriods, Pepcid and Benadryl. The hives and redness started to disappear right after the shot.
56 2021-03-30 lymph node swelling, peripheral swelling, fluid retention Evening of injection. Serve pain in whole arm and arm pit into part of right chest first night. Swel... Read more
Evening of injection. Serve pain in whole arm and arm pit into part of right chest first night. Swelling of right arm to hand, fluid in and around arm pit. Next day, fever 102.7 headache, joint pain, muscle pain, and arm still affected. Day 2, still fluid in arm pit area and headache. Evening of day 2 ran fever of 102.6 with pain on right side of ne k and headache. Day 3 headache and fluid in and around arm pit has subsided a bit.
56 2021-03-30 lymph node swelling The side effect with the second dose of Pfizer-Biotech was swollen lymph nodes (lymphadenopathy) on ... Read more
The side effect with the second dose of Pfizer-Biotech was swollen lymph nodes (lymphadenopathy) on the left armpit. The side effect began on March 27, 2021, around 2:00 am. As of March 31, 2021, there are still side effects but not as bad as March 27th.
56 2021-03-30 oral herpes Head ache every day starting the day after, 3-day later, rash in throat (cold sores or something sim... Read more
Head ache every day starting the day after, 3-day later, rash in throat (cold sores or something similar on roof of mouth), rash under right arm and rash on lower left-back.
56 2021-03-30 swelling face There was an allergic reaction that caused itchiness all over the body as well as facial swelling.
56 2021-03-30 swelling face Swollen lip and cheek, chin right side(3/24) Welts on both thighs 3/25, 3/25 Dr. prescribed prednis... Read more
Swollen lip and cheek, chin right side(3/24) Welts on both thighs 3/25, 3/25 Dr. prescribed prednisone 10 day pack
56 2021-03-31 swelling angioedema; swelling of lips; numbness in tongue and mouth; This is a spontaneous report from a cont... Read more
angioedema; swelling of lips; numbness in tongue and mouth; This is a spontaneous report from a contactable other hcp. A 56-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 16Mar2021 09:30 (Batch/Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant. No Known allergies. The patient took other medications (many, none new) in two weeks. The patient experienced angioedema, swelling of lips, numbness in tongue and mouth on 16Mar2021. The AEs resulted in Doctor or other healthcare professional office/clinic visit. The patient received zyrtec and allegra and epi pen for prn use. No covid tested post vaccination. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the compatible temporal association and the product's known safety profile, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the event angioedema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
56 2021-03-31 lymph node swelling Ha,malaise, body aches, nausea , vomiting,diarrhea,, bilateral ear aches, swollen glands under chin... Read more
Ha,malaise, body aches, nausea , vomiting,diarrhea,, bilateral ear aches, swollen glands under chin,
56 2021-03-31 peripheral swelling Migraine with pain level of 9; nausea, joint aches to where moving is difficult and extremely painfu... Read more
Migraine with pain level of 9; nausea, joint aches to where moving is difficult and extremely painful. hand swelling; chills and low grade fever.
56 2021-04-02 lymph node pain, lymph node swelling Swollen underarm. Very painful
56 2021-04-03 swelling Swelling, pain and redness that continues to spread 3 days after injection.
56 2021-04-04 lymph node swelling, peripheral swelling swollen left hand, chills, headache, body aches, swollen lymph nodes in left armpit, fatigue, post m... Read more
swollen left hand, chills, headache, body aches, swollen lymph nodes in left armpit, fatigue, post menopausal bleeding/spotting/cramping, increased pain in healing right torn rotator cuff
56 2021-04-04 peripheral swelling everything hurts, no energy, arm swelled and turned red. headache.
56 2021-04-05 anaphylactic shock Within 3 minutes of receiving the Pfizer shot I began to feel dizzy. Five minutes later I went into ... Read more
Within 3 minutes of receiving the Pfizer shot I began to feel dizzy. Five minutes later I went into anaphylactic shock. At the site, 911 was called. Before the ambulance arrived, I was given 100mg of Benadryl and 3 Epi Pens were injected into my left leg. The ENTs did not give me anything in the ambulance. At the ER, I was treated by the doctors and nurses that help with my anaphylactic shock reaction to the vaccine.
56 2021-04-05 swelling face Swollen lips and face/ tingling Difficulty swalling Difficulty breathing VERY thursty Very soar thro... Read more
Swollen lips and face/ tingling Difficulty swalling Difficulty breathing VERY thursty Very soar throat Racing heart rate High blood pressure Went to the ER. They were able to lower my racing heart with a beta block. Still suffering elevated heart rate and high blood pressure. No prior history of heart problem or high blood pressure.
56 2021-04-05 swelling face Face turned hot and red about 30 minutes after the vaccination. A few minutes later, a tingling sens... Read more
Face turned hot and red about 30 minutes after the vaccination. A few minutes later, a tingling sensation began, followed by a general feeling of fullness throughout my face, as if my face was swelling. This was very concerning, and I began checking in the mirror for physical swelling in my face. The sensations of tingling and fullness continued for 30-45 minutes. My face was still red and hot for 6 hours after the vaccination.
56 2021-04-05 swelling After about 15 min I started to get numbness, tingling , and swelling on my entire left side. It inc... Read more
After about 15 min I started to get numbness, tingling , and swelling on my entire left side. It included difficulties seeing and lack of hearing on the left side. I could feel the "blood flow" in my head, which was super uncomfortable, because I was afraid of getting a stroke. I went to report to the Medical Doctor on side at the Convention Centre. They kept monitoring blood pressure and my responses. Nothing really was done. Symptoms stayed for about 1.5 hours the same. After that they decreased but my side was still numb and swollen (not back to normal). However, I left to go home. After about 24 hours those symptoms were gone and only headache, fatigue remained. I received my second vaccination on 04/04/2021 at about 1:15P: Pfizer, Lot#ER8733 There, I used my right arm. Same thing, after about 15 min, I started to get tingling, numbness, difficulties hearing and seeing. Headache was worse than the first time. Again I remained under observation for about 1h. No results. Symptoms lessened. I went home. At night I developed nausea, severe kidney pain, had to vomit several times, and had a weird hot feeling inside my body=could feel my blood flow. It felt as if it was really hot. it was extremely scary, as I again was afraid of developing a stroke. Now, 2 days later, I still am feeling extremely weak, nauseous, headaches, some numbness.
56 2021-04-06 lymph node swelling, lymph node pain Beginning 5 days after injection on March 16, I started experiencing back pain. The next day, the 17... Read more
Beginning 5 days after injection on March 16, I started experiencing back pain. The next day, the 17th, a small red rash started near my navel with itching and started with headache and malaise. Later that same day I looked on my abdomen and right torso and notice an additional red rash on my right torso, under my arm, leading from my navel. Itching became intense and the pain started. Vesicles stared on the 18th and I was unable to get an appointment until the 19 the where the MD confirmed Shingles. I was started on Valtrex (generic) 1 tab bid for 7 days. The pain was so intense, I was unable to have any clothing, bedding touch the area. I had a fever, chills, intense pain, with inability to raise right arm due to pain. There was also a lymph node that was tender and swollen under my right arm. Treatments included Calamine lotion and OTC Lidocaine applied topically and the fever and headache were managed with Tylenol 500 mg every 3-4 hours until it became unbearable and I requested additional pain meds. The MD gave me Oxycodone which helped some. The lymph node were no longer tender and sore by day the 28th or so. The lesions/vesicles started to dry up by 04/02/21 but the itching persisted and remained very painful. The back pain persisted throughout with difficulty sleeping due to the pain. By the 4th of April, the lesions had dried completly and all the scabs had fallen off. Some of the nerve pain persisted but clothing was more bearable by this time. As of today, there is some itching that remains and some back pain with some tenderness on my right torso.
56 2021-04-07 swelling face Left cheek, eye socket and nose felt numbness and tingling and slight swelling of left side of face.... Read more
Left cheek, eye socket and nose felt numbness and tingling and slight swelling of left side of face. It started around 10:30 am and most of the numbness and tingling eased up by 3:30 pm, except for numbness in eye socket and tingling in nose. Pain in left arm and woozy feeling most of the day, pain in left collar bone and down left shoulder blade and left breast. The pain has been consistent but not extreme. I have used Tylenol so the pain is bearable.
56 2021-04-08 swelling, swelling face Angioedema; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; swelling fac... Read more
Angioedema; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; This is a spontaneous report from a contactable nurse (patient herself). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration on 17Mar2021 06:00 PM as single dose in right arm for COVID-19 immunisation at Pharmacy or Drug Store. The patient's medical history included idiopathic angioedema and no chronic health conditions. Patient had allergies to medications, food, or other products included Zithromax - anaphylactic, several other antibiotic - rash, hornet and wasp sting allergies. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 18Mar2021 at 10:00 AM, the patient experienced angioedema - swelling face, eyes, lips and throat which occurred 16 hours after injection. Event resolved with use of Benadryl. Prior history of angioedema. Since symptoms resolved with Benadryl, I did not seek further medical care. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events were recovered in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
56 2021-04-08 lymph node pain Side effects began about 14 hours after 2nd dose. Fever, extreme pain in back, legs, head and arm pi... Read more
Side effects began about 14 hours after 2nd dose. Fever, extreme pain in back, legs, head and arm pits. Dizziness. Still experiencing side affects 30 hours later.
56 2021-04-09 lymph node swelling After 2 minutes a lot of bitterness in the mouth that lasted 4 hours, burning in the tears in both e... Read more
After 2 minutes a lot of bitterness in the mouth that lasted 4 hours, burning in the tears in both eyes that disappeared a few minutes later and a strange sensation in the ear that still continues, on day 6 after having vaccinated inflammation in the armpit glands left that continues.
56 2021-04-10 lymph node pain I had a sore arm, headache and chills on April 9 and 10. On April 11, I woke up about midnight with... Read more
I had a sore arm, headache and chills on April 9 and 10. On April 11, I woke up about midnight with chills, headache, sore lymph node in left arm and nausea. I had vomiting and diarrhea with severe dizziness and felt like I was going to pass out.
56 2021-04-10 lymph node swelling chills, body aches, joint pain, swollen lymph node in left underarm
56 2021-04-10 lymph node swelling A few hours after injection, I noticed pain in my right arm at injection site with redness. Also a b... Read more
A few hours after injection, I noticed pain in my right arm at injection site with redness. Also a bit of nausea, and chills. I also experienced headache and congestion. The following day I had a very strong headache and very strong pain at injection site as well as swollen lymph nodes. On the third day I still have headache and pain in my arms as well as a swollen lymph nodes
56 2021-04-10 peripheral swelling 102.5 fever, chills, severe headache, body aches, nausea, vomiting, arm pain and swelling
56 2021-04-12 anaphylactic reaction allergic reaction/Allergic anaphylactic reaction; lungs were filling up with fluid; throat was closi... Read more
allergic reaction/Allergic anaphylactic reaction; lungs were filling up with fluid; throat was closing; Main trouble is breathing and is out of breath; legs sore; Throat sore; Cough; hard for her to walk; tired; trying to swallow a tablet and digest it and it gets stuck; trying to swallow a tablet and digest it and it gets stuck; breathing was heavy; choking; trying to swallow a tablet and digest it and it gets stuck; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 24Mar2021 (Lot Number: ER2613) as a single dose for to prevent COVID (covid-19 immunisation). Medical history included having blood clot from 2019 to Mar2021 which the patient stated a couple of weeks ago (Mar2021), she had an ultrascan in her leg and the blood clot was not there, but she is on medication. The patient has recovered completely from blood clot (not ongoing). Concomitant medication included warfarin (WARFARIN) to prevent from having blood clot ongoing since Jun2019. The patient previously took gabapentin for pain but had throat started closing, allergic reaction, coughing and was intubated until she was released from hospital; and albuterol [salbutamol] for dyspnoea but had nebulizer to open up her airways and prevent closing and did not work (drug ineffective). The reporter mentioned that the patient ended up in the ICU because of the COVID vaccine. As soon as the vaccine was administered within seconds, the patient experienced a reaction and was given an epi pen, another epi pen even an epinephrine drip and was sedated and intubated. The reporter mentioned that they gave the patient the first shot of epi pen and it did not work, and she was given a second one and a third one plus steroids. By the time the ambulance people arrived, they hooked the patient up to an IV and gave her additional epinephrine and administered another epinephrine. The ambulance guy told her; she does not need to keep up with them because they needed to go to the hospital ASAP because the patient is not getting better but getting worse. Once the patient got to hospital, she was intubated because her throat was closing. The reporter stated that the patient has allergies to begin with and this was worse than the first time she had to be intubated. The epi pens did not work, the patient was intubated and then had to be sedated. The patient was on Propofol in order to sedate her and later on in the evening was given Fentanyl to relax her then the epinephrine drip was removed at 6 pm on 24Mar2021. The epinephrine drip was started in the emergency room and the patient could not be moved to the intensive care unit until she was somewhat stable. The patient was moved to the intensive care unit and was there overnight and by the time next morning she was able to be extubated where they removed the tube from her around 9:30 to 10:00 25Mar2021. Of course, the patient was taken off Propofol, but she went through a lot and her legs are sore, throat is sore, and is coughing on 25Mar2021 because of the side effects from being intubated and that she went through a lot. The intensive care unit doctor said that the patient can no longer have the vaccine and she would only be 70% protected till whenever they are not sure how long the vaccine will last. The adverse events almost took the patient's life which made the reporter angry at that. The reporter is not sure what the contents in the vaccine that it in the other drugs and vaccines since there is something that is contained in all of them and the patient was not allowed to have any whether it is the Pfizer or Moderna and it is even up for discussion for even the flu shot because of the reaction and there does not want to be any chances and that everything should be proceeded with caution. The reporter wanted to know what is in the COVID 19 vaccine to see about what could have caused the allergic anaphylactic reaction. The reporter stated and the fact that the epi pen did not work, she was taken aback. The reporter added that the doctor had a hard time intubating because of her throat but they were able to intubate from the second time. The reporter stated that it is taking a while but her wife is recovering and feeling it is taking a while taking a little bit longer. The reporter also stated that they kept the patient in the intensive care unit overnight and after the tube was removed in the morning, by the late afternoon she was moved to a different floor to continue to be observed and the intensive care doctor said 2 days out her wife would be safe to go. The patient stood up but it was hard for her to walk on 25Mar2021 because it could have been from the epi pen, but she is not sure. The patient stated the side effect came out of the allergic reaction and it was on Thursday 25Mar2021. Patient stated the main trouble is her breathing, she is out of breath still and really sore throat on 25Mar2021. The patient stated that the leg sore is still ongoing and is about the same. It was mentioned that the throat sore was still ongoing but some days are worse and some days are better. The patient stated that when she has a problem trying to swallow a tablet and digest it and it gets stuck on Mar2021. It was stated that the cough was not going away. The cough comes and goes away. She will cough for five minutes constantly and then it disappears then she will fall asleep and wake up coughing. It's as if she is choking (Mar2021). When she is talking, she coughs more. With regards to the allergic anaphylactic reaction, the patient stated she is experiencing the aftereffects of the allergic reaction and being intubated like being out of breath. The patient stated that will come in time and that's what happens when she gets intubated. Her breathing was heavy and comes back fully with rest on Mar2021. This has taken a lot out of her. She was feeling tired which was still ongoing it is about the same but comes and goes on 25Mar2021. The patient is experiencing lingering side effects and the patient does not feel as if she has recovered completely. It was also mentioned that the patient was intubated on 24Mar2021 to 25Mar2021. It was reported that treatment of the patient included Epi Pen, Epinephrine Autoinjector USP 0.3 mg (Epinephrine injection manufacturer was Mylan) which the patient was given at least three injections (two in the right leg and 1 on the left) then received another in the ambulance (unknown site). Patient received an Epinephrine drip and it was like 0.1 mg all the way up until 6 pm (only on 24Mar2021). The epinephrine drip was started when patient was intubated at the hospital. It was given for patient's allergic reaction through IV. The patient's lungs were filling up with fluid so her airway was restricting her from breathing and to prevent damage of the lungs that is when the intubation came in. The patient also received Prednisone which the reporter does not recall when this medication was started it may have been after the epinephrine drip was removed but she is not sure if they started the prednisone after or if it was the same evening which the reporter kind of thinks it was. The reporter stated that the patient took Propofol 24Mar2021 to 25Mar2021 which was given through the patient's IV and was given to help her airways being intubated, they sedate their patients. The patient also received fentanyl which must have been added either right before Epinephrine drip was removed or after but reporter does not recall. Patient was given Fentanyl 24Mar2021 to 25Mar2021 through her IV. Patient received this medication to relax because sometimes it is like some patients tend to want to sit up and kind of hear you, hear what people are saying and to relax patient sometimes because they can get scared and not exactly sure what is going on. The events anaphylactic reaction, pulmonary oedema, throat constriction and breathing difficult. The patient underwent lab tests and procedures which included lung was checked from a CT scan was unknown results on 12Jun2019, D dimer test was elevated on an unspecified date, ultrascan in her leg (ultrasound scan) blood clot was not there on Mar2021 and weight was probably weighs 180 or her weight may be a little less like 175 on an unspecified date. The outcome of the events anaphylactic reaction and throat constriction were recovering, as for the events leg pain, throat sore, cough and tiredness were not recovered while the outcome of the other events was unknown.
56 2021-04-12 swelling, swelling face Hives on face 20 minutes after injection, angioedema follow with swollen face, eyes and itching on f... Read more
Hives on face 20 minutes after injection, angioedema follow with swollen face, eyes and itching on face. Within 5 hours all over itching, drainage from eyes throat itching
56 2021-04-12 c-reactive protein increased Patient is having myalgias, intermittent fevers, headaches, arthralgias, and chills still at 12 days... Read more
Patient is having myalgias, intermittent fevers, headaches, arthralgias, and chills still at 12 days after the vaccine
56 2021-04-12 lymph node inflammation Day 1-2 - Sore arm and injection site Day 1 -4 - Mild headache, somewhat lathargic Day 7 - 14 ... Read more
Day 1-2 - Sore arm and injection site Day 1 -4 - Mild headache, somewhat lathargic Day 7 - 14 - Swollen and sore left arm, forearm, hand, wrist into thumb; Sore left shoulder and left back/shoulder. Several lumps in neck, approximately 3 - 4, diagnosed by doctor as Lymphadenitis.
56 2021-04-12 lymph node swelling upper back & shoulder blades pain one day after vaccination, then left neck pain (swollen lymph node... Read more
upper back & shoulder blades pain one day after vaccination, then left neck pain (swollen lymph nodes on the left neck) 4 days after the vaccination. mild headaches since one days after vaccination
56 2021-04-12 lymph node swelling swollen glands, sore throat, tingling on rt side of leg
56 2021-04-13 lymph node swelling, lymph node pain Woke around 5:30 am the morning after the 2nd shot with chills and body aches. Had severe fatigue, ... Read more
Woke around 5:30 am the morning after the 2nd shot with chills and body aches. Had severe fatigue, joint and muscle aches all day. Took ibuprofen every 5 to 6 hours. The 2nd day after the shot, no chills, but continued fatigue and body aches although better than the day before (continued taking ibuprofen). The 3rd day, swollen and tender lymph nodes under my left arm and over my left clavicle. Lymph nodes continue to be swollen and tender 5 days after shot. Energy level has returned to normal and body aches are gone.
56 2021-04-13 lymph node swelling I HAD THE PFIZER VACCINE ADMINITERED AT FACILITY ON 3/31/21. THIS WAS THE FIRST DOSAGE. ON DAY 5 I H... Read more
I HAD THE PFIZER VACCINE ADMINITERED AT FACILITY ON 3/31/21. THIS WAS THE FIRST DOSAGE. ON DAY 5 I HAD PAIN IN MY LEFT LEG FROM GROIN TO CALF. BY DAY 5, I BEGIN TO LIMP, MY LEG WAS BURNING, INCREASED PAIN AND I COULD FEEL WHAT I BELIEVE TO BE BLOOD CLOTS AND MY LYMP NODE IN MY LEFT GROIN FELT SWOLLEN. OVER THE COURSE OF 2 DAYS, THE PAIN BECAME WORSE. I CONTACTED MY DOCTOR AT FACILITY FOR A TELEPHONE INTERVIEW IN REGARDS TO WHAT I STATED ABOUT THE PAIN. CLOTS, SWOLLEN LYMP NODES ETC.. AND EXPLAINED THAT THIS OCCURED AFTER OBTAINING THE COVID-19 VACCINE. I WAS ADVISED TO HAVE A DOPPLER PERFORMED AT THE ER. I WENT TO THE ER LATER THAT EVENING AND WAS TOLD THAT DOPPLERS WERE NOT COMPLETED AFTER 4 P.M. BLOOD WORK WAS PERFORMED BY HOSPITAL. MY LAB WORK WAS NORMAL AND I WAS ADVISED THAT I WOULD BE CONTACTED THE NEXT MORNING FOR AN APPOINTMENT FOR THE DOPPLER. ON 4/8@1:00 PM, I HAD THE DOPPLER PERFORMED AT HOSPITAL. I WAS TAKEN BACK TO THE ER AND WAS INFORMED THAT I HAVE DVT AND THIS WAS POSSIBLY LIFE THREATING. I HAD NO PRIOR HISTORY OF CLOTS. I'M CURRENTLY TAKING ELIQUIS FOR THE BLOOD CLOTS, WEARING A COMPRESSION GARMENT AND TYLENOL FOR PAIN. I WAS ADVISED TO HAVE ANOTHER DOPPLER COMPLETED IN 6 MONTHS
56 2021-04-14 lymph node swelling, lymph node pain headache, fever, chills, aches (18 hours) painful swollen lymph nodes under right arm (7 hours at ti... Read more
headache, fever, chills, aches (18 hours) painful swollen lymph nodes under right arm (7 hours at time of report and continuing)
56 2021-04-14 peripheral swelling She got her vaccine and the arm had swollen up, red and hot to the touch and then after a couple of ... Read more
She got her vaccine and the arm had swollen up, red and hot to the touch and then after a couple of hours she could not lift it to move it, she could not move it backwards. This then moved up her arm, across the shoulders and to the neck on the right side. She took Ibuprofen. The arm feels fatigued, but she can move it, but the range of motion is not as easy as it used to be. It still feels swollen, but there is nothing that you can see.
56 2021-04-16 lymph node swelling, peripheral swelling I have a very swollen left leg. It began slowly and became worse. I thought that I sprained my lef... Read more
I have a very swollen left leg. It began slowly and became worse. I thought that I sprained my left knee on March 13th. (I had my first vaccine shot in my left arm on March 11th. ) I thought that I would let it heal. My second shot was April 1st and my left leg became very painful after that. I went to the Doc. for a knee sprain, was sent to Orthopedic. I received an X-ray and an MRI. There is tricompartmental osteoarthritis, with 2 degenerative meniscus tears. It occurred to me today that my knee joint may be reacting to the vaccination. I did have swollen lymph nodes on my left side in neck and under my arm after the second shot. My knee has had arthritis and possibly the degenerative meniscus tears but it has never become swollen and inflamed. The swelling and pain has persisted for over 2 weeks now. I?m not sure if it is related but I thought that I should share this with you. If there is anything that you can help with, please do. I have been so very grateful for the vaccination. Thank you!
56 2021-04-16 swollen extremities Pain all over, very fatigue, foggy, chest tiredness, exhaustion with ambulation, plum size swelling,... Read more
Pain all over, very fatigue, foggy, chest tiredness, exhaustion with ambulation, plum size swelling, pain and redness under right armpit, slight sore throat, ear ache, and stuffy nose gradually got worse since 23 April
56 2021-04-16 peripheral swelling I started having pain under my armpit and some swelling, then pain went up to my armpit and swelling... Read more
I started having pain under my armpit and some swelling, then pain went up to my armpit and swelling that it hurt when I have my arm next to my body! It disturbed my sleep and my daily comfort I had to keep my arm away or on a pillow at night. For two days I used heated pad and took the supplement Oregano oil (1 capsule/day) as I suspected it was my lymph glands, the third day the pain was slight in my armpit and felt a little pain in my left shoulder blade.
56 2021-04-16 swelling face Facial numbness; Puffiness; This is a spontaneous report from a contactable consumer . A 56-years-ol... Read more
Facial numbness; Puffiness; This is a spontaneous report from a contactable consumer . A 56-years-old female patient received the second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0142 and expiry date was not provided), via an unspecified route of administration, administered in Arm Left on 04Jan2021 15:30 as single dose for COVID-19 immunisation. Medical history included Early menopause, hypothyroidism from Oct2020 still ongoing and Pollen-Seasonal allergies, Sinus congestion. The patient previously took first dose of historical vaccine BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EH9899 and expiry date was not provided), via an unspecified route of administration, administered in Arm Left on 14Dec2020 15:30 as SINGLE DOSE for covid-19 immunisation and experienced Facial Numbness, swelling, flushed, Extreme fatigue 24 hrs after vaccine, multi joint pain, Also felt 'a little bit' of nausea, Funny- Brain fog. Concomitant medications included estrogens conjugated (PREMARIN) taken for premature menopause as 0.625mg Daily, levothyroxine sodium (SYNTHROID) taken for hypothyroidism as 50mcg daily in Am with water 30minutes prior to eating. Past drug event included Codiene(CODEINE) which causes nausea and cetirizine hydrochloride(ZYRTEC) for seasonal allergies. patient was given antihistamines; Zyrtec 1/2 tablet daily for seasonal allergies.On Jan2021, the patient experienced facial numbness and puffiness. Treatment received for the events reported. Outcome of the events was unknown.
56 2021-04-19 lymph node swelling Return of injection site soreness at rest but increasing with range of motion, swollen lymph nodes ... Read more
Return of injection site soreness at rest but increasing with range of motion, swollen lymph nodes in axilla injection side (L). And limited range of motion due to pain. Pain continues currently but lymph node seem to have returned to normal. Pain mainly with movement today but does intermittently occur at rest. I haven?t seen the physician because I felt this would resolve after researching the side effect awesome online medical resource sites.
56 2021-04-19 peripheral swelling, swelling face Day after vaccine bilateral swelling of nose, 2nd day right side facial swelling, each day facial sw... Read more
Day after vaccine bilateral swelling of nose, 2nd day right side facial swelling, each day facial swelling would increase. Went to Urgent Care. Started immediately on Keflex and Deltasone. It took a week for the facial swelling and cellulitis to clear up. At the same time I was experiencing right and left hand numbness and finger tightness at night and AM. Can not make a fist or clench my fist together. The metacarpophalangeal was swollen and causing severe pain. Dr ordered CBC, CMP, Arthritis Profile, and ANA.
56 2021-04-20 lymph node swelling Blacked out; feel light headed; unbalanced; Having trouble to focus with my eyes; Head feels full; L... Read more
Blacked out; feel light headed; unbalanced; Having trouble to focus with my eyes; Head feels full; Lymph nodes in head, neck and under arms swollen; very high blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 10:45 (Batch/Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Six days after the vaccine (on 23Mar2021 10:15 ), the patient started to feel light headed, unbalanced. Blacked out on March 23rd for a very short time. Having trouble to focus with his eyes. Head feels full. Lymph nodes in head, neck and under arms swollen. Very high blood pressure and now needing medication for that. These last two weeks have been a nightmare and thinking he was going to die and was in the Emergency room. No treatment was received for the events. Event blacked out seriousness was medically significant. The events outcome was not recovered.
56 2021-04-21 swelling Nausea, sharp pain in lower calves, pain in temple, tight pressure around forehead, pain in lower le... Read more
Nausea, sharp pain in lower calves, pain in temple, tight pressure around forehead, pain in lower left back of head, slight temperature, lightheaded dizziness, swollen stomach and nausea, tightness in chest, rapid heart rate, ice cold feeling in feet, some chills, tight constricting feeling in neck.
56 2021-04-22 anaphylactic reaction pt had the 1st dose of COVID-19 vaccine and had oral swelling, tongue swelling and difficulty swallo... Read more
pt had the 1st dose of COVID-19 vaccine and had oral swelling, tongue swelling and difficulty swallowing. patient was transferred to the ED. IV access was established and patient was given IV fluids, IV Benadryl, famotidine and Solu-Medrol for initial management of possible allergic reaction. Patient was later given 0.5 mg IM epinephrine for treatment of anaphylaxis. Patient was observed in the emergency department for 3 hours with no return of symptoms. and discharged.
56 2021-04-22 lymph node swelling I just spent 14 hrs in the ER trying to treat, what I was sure to be, an ovarian cyst. The pain had ... Read more
I just spent 14 hrs in the ER trying to treat, what I was sure to be, an ovarian cyst. The pain had been building over the past mo. I procrastinated going to the ER, because I wanted my 2nd dose b4 going, which was yesterday. I had exams, pelvic, ultrasounds, Cat scans, labs, etc & they found nothing. I can barely walk without doubling over. 4 wks ago I had an L-5 block & trigger point injections with steroids, due to inflamed nerve roots, & inflamed L thigh. 1 wk later, I had my 1st shot, L arm. Within days my abdomen began hurting mildly, but I thot it'd subside. It never occurred to me that it could be related to the vaccine. 2 wks later, it was unbearable & I thot it an ovarian cyst. I waited for my 2nd shot appt, b4 going to ER, in case I was hospitalized. I didn't want to ruin my 2nd dose, as I have lung issues. ER Dr said, I had "undetermined inguinal pain". Then, I found a study about women, hormonal changes & the vaccine. I saw that lymph nodes can get inflamed after a vaccine. Now, I think I had a vulnerable area on my L side, then rec'd steroids L side, which lowered my immune system. Next, I rec'd my 1st shot L side, & my "inguinal lymph node" on L side became inflamed. It got progressively worse, & now my 2nd dose was yesterday, also on my L side, & has aggrivated it even more. Tomorrow I see my pcp. It feels exactly like my ovary's swollen, & the inguinal lymph node's located right in the same place, so after all tests have been negative, I suspect a connection & I'll discuss with pcp for more testing & treatment.
56 2021-04-22 peripheral swelling Injection in left arm on Sunday, 3/28 - 4PM. By Tuesday, 3/30 - I stared feeling unusually / more t... Read more
Injection in left arm on Sunday, 3/28 - 4PM. By Tuesday, 3/30 - I stared feeling unusually / more than normal tired. By Thursday, April 1, 2021, symptoms of headache, body aches, extreme tiredness where all I wanted to do is sleep, depression, a bit of nausea continued and by 4/1 I had to go home from work. My lower calves (both legs) and ankles and feet were swollen, throbbing and felt like there were pin pricks / tingly sensation in my legs. I stayed home from work on that Friday, April 2, slept and slept. I tried to do minimal tasks that exhausted me - like wash dishes. I took aspirin - drank a ton of water and had lay with both legs elevated. By Sunday I was fine.
56 2021-04-22 swelling face Same rash as 2 previous events: Rash started in the face and traveled to neck, torso, and legs. Itch... Read more
Same rash as 2 previous events: Rash started in the face and traveled to neck, torso, and legs. Itching. This time the rash was accompanied by significant facial swelling.
56 2021-04-22 swelling face Same as 2 previous events: sudden onset rash on face, neck, torso, arms, and legs New symptom with t... Read more
Same as 2 previous events: sudden onset rash on face, neck, torso, arms, and legs New symptom with this event included significant swelling of the face
56 2021-04-23 lymph node swelling She had a lymph tissue lumps fever chills muscle aches headache. She said she felt about 50% better ... Read more
She had a lymph tissue lumps fever chills muscle aches headache. She said she felt about 50% better the following day. She eventually succumbed and passed away.
56 2021-04-23 peripheral swelling Red swollen arm. Brown blister
56 2021-04-23 swelling face Patient was complaining of swelling in face and an itchy throat.
56 2021-04-25 peripheral swelling 1) Scleritis - left eye - previously controlled scleritis flared. I was on 5 mg of prednisone dail... Read more
1) Scleritis - left eye - previously controlled scleritis flared. I was on 5 mg of prednisone daily, but my doctor increased it to 15 mg daily and added 1 drop of 0.5% prednisone solution, 4x per day. The flare-up was on 4/21, saw my doctor on 4/23 in the am; had second shot in the afternoon. HORRENDOUS inflammation of left on on 4/24, still being resolved. 2) Postmenopausal menstrual bleeding on 4/24, 4/25, and 4/26. I've called my oby-gyn who referred me for a pelvic ultrasound on May
56 2021-04-27 swelling Angioedema; chest tightness; SOB; This is a spontaneous report from a contactable nurse (patient). T... Read more
Angioedema; chest tightness; SOB; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar events for different doses. This is the second of two reports. A 56-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8734) administered in right arm on 07Apr2021 at 18:00 (at the age of 56-years-old) at single dose for COVID-19 immunisation. Medical history included prior history of idiopathic angioedema, several other antibiotics allergies - rash, hornet and wasp sting allergies; no chronic health conditions. Patient was not pregnant. No COVID prior vaccination; no COVID tested post vaccination. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken at 50 mg for 3 for 12 hours pre-dose; no other vaccine received in four weeks. The patient previously took ZITHROMAX and experienced allergies - anaphylactic; the patient received the first dose of BNT162b2 (lot number: EP7534) on 17Mar2021 at 06:00 pm (at the age of 56-years-old) administered in the right arm for COVID-19 immunisation and experienced angioedema. The patient experienced angioedema, chest tightness, shortness of breath (SOB); initial reactions started around 12:00 noon on 08Apr2021, slowly continued to get worse throughout the day. Had to go to emergency room (ER) that evening. Angioedema reoccurred the following night and again on 10Apr2021. Another trip to ER on 10Apr2021 due to angioedema, chest tightness and SOB. The events were treatment with BENADRYL, SOLUMEDROL IV, PEPCID IV, nebulizer. The patient had recovered from the events in Apr2021.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Angioedema, Chest Tightness and shortness of Breath. Consider also possible contributory effects from patient's medical history The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021330573 same patient, vaccine different dose
56 2021-04-27 lymph node swelling Severe swelling, redness and pain in right arm pit (Lymph Noles) and right arm; Seen by doctor and h... Read more
Severe swelling, redness and pain in right arm pit (Lymph Noles) and right arm; Seen by doctor and had to get a shot for inflammation, and 2 prescriptions. Around 11:30 pm on 4/27/21, had nausea, diarreah, chills/shaking uncontrollably and headache.
56 2021-04-27 swelling face, peripheral swelling, white blood cell count increased Patient tells me 2 days prior to vaccine on 3/3 (Pfizer) she had mild hives?not unusual for her in ... Read more
Patient tells me 2 days prior to vaccine on 3/3 (Pfizer) she had mild hives?not unusual for her in the spring. They typically occur along with seasonal allergies and she thinks the hives are unrelated to current rash. She went ahead and had the 1st Pfizer vaccine on 3/3. She developed a new circular rash at the injection site on the left arm and new rash over the left side of her back described as ?on fire?. she was seen for a telemedicine clinic visit diagnosed with possible shingles and was prescribed treatment. Did not improve significantly. She went ahead and had the second Pfizer jab on 3/24. She developed extreme tenderness at injection site. the rash that was on her back got much worse and spread. The rash occurs any place she scratches, has blood drawn or gets a band-aid placement. After that second shot she also noticed that her hip joints feel ?weak and unhinged". . Has also had similar symptoms of weakness in bilateral shoulders. Feels like her leg muscles are weak (points specifically to quadriceps). She has trouble repositioning herself and doing normal activities that she had been doing without difficulty just a few weeks ago. Her RN notes that she can get out of bed and walk to bathroom but is unsteady and shuffles. Has also noticed facial and periorbital swelling with purple discoloration and darkness around eyes. Had a faint pink rash extending from eyelids up over brows that has now decreased. Feels her legs are puffy and swollen.
56 2021-04-27 swelling face After 1st vaccine had an endocrine reaction -- facial swelling (moon-face) along with thrush. Also ... Read more
After 1st vaccine had an endocrine reaction -- facial swelling (moon-face) along with thrush. Also had severe headache.
56 2021-04-28 lymph node swelling, lymph node pain Patient with significant painful lymphadenopathy 2 days after first Covid vaccine, 18 days after sec... Read more
Patient with significant painful lymphadenopathy 2 days after first Covid vaccine, 18 days after second Covid vaccine
56 2021-04-28 peripheral swelling My arm immediately hurt at injection site. Later that evening my arm swelled and was more painful, a... Read more
My arm immediately hurt at injection site. Later that evening my arm swelled and was more painful, all the way down to my elbow. I took Ibuprofen In the night while I slept my arm swelled more and became even more painful and swollen, all the way down to my thumb. I took Acetaminophen. In the morning I had an upset stomach and diarrhea (that lasted off and on for over 3 weeks), but the pain and swelling eventually subsided within 3 days.
56 2021-04-29 anaphylactic reaction Anaphylaxis
56 2021-04-29 lymph node swelling, lymph node pain I have a lymph node on my left side of my neck that is swollen and painful. ( near the clavicle)
56 2021-04-30 lymph node swelling I felt tingling in the feet hands and mouth; After a lot of sleep; second day strong pains began in ... Read more
I felt tingling in the feet hands and mouth; After a lot of sleep; second day strong pains began in the back; Inflammation in the ganglia; shortness of breath; High or slow heart rate; I began to feel strong pain in my spine, legs and joints; I feel uncoordinated to speak; I began to feel strong pain in my spine, legs and joints; It is a horrible feeling.; This is a spontaneous report from a contactable consumer (patient herself). A 56-years-old non-pregnant female patient started therapy with bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0162), via an unknown route on 16Apr2021 at 1:00 pm in the arm left as a single dose for COVID-19 immunization. The patient's medical history included hypertension and a liver problem. Patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient 2 weeks prior to the COVID vaccine included Bisoprolol (5mg). Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. The patient did not have allergies to medications, food or other products. On 17Apr2021 at 14:30, the patient felt tingling in her feet, hands and mouth and became very sleepy. On the second day after vaccination, patient felt strong pain in her spine, legs and joints and neck. The patient also reported neck lymph nodes inflammation and shortness of breath. Patient reported that high or low heart rate and she felt uncoordinated to speak. Patient described that it as a horrible feeling. The outcome of the events was not resolved. It was unknown if the patient taken any treatment due to AE. No follow-up attempts are needed. No further information is expected.
56 2021-04-30 swelling face Left side face swelling; This is a spontaneous report from a contactable consumer reported for herse... Read more
Left side face swelling; This is a spontaneous report from a contactable consumer reported for herself. This 56-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) via an unspecified route of administration in the left arm (reported as "left shoulder") on 07Apr2021 13:00 as a single dose for covid-19 immunisation. Medical history included asthma diagnosed as a child. The patient stated it's not ongoing, it's more during seasonal allergies. She took Singulair to help. Concomitant medications were unknown. The patient had Pfizer covid19 vaccine on Wednesday 07Apr2021 and left side face swelling yesterday on 08Apr2021. It's on the left side of the face. It started around the eye and currently she can feel it running down the side of the face. Left side face swelling was reported as worsened. The patient asked if she would be okay to get the second vaccine. She stated she was not in pain, but was concerned that she won't be able to get the second vaccine. She had not treated the swelling yet, and was not sure if she should see her doctor. She was scheduled for the second dose of the vaccine. The patient had no prior Vaccinations (within 4 weeks). Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
56 2021-05-01 fluid retention My legs filled with fluid, causing weight gain of 2 pounds overnight. I got eczema. I had a slight h... Read more
My legs filled with fluid, causing weight gain of 2 pounds overnight. I got eczema. I had a slight headache. I contacted a family member who is a doctor and did the following: drank plenty of water, wore compression stockings, cut back on salt, elevated legs when possible. The doctor suspected that it was a histamine release that caused the fluid retention, so he suspects I am allergic to something in the vaccine. I am on Claritin daily (including the days before and after receiving the vaccines).
56 2021-05-02 c-reactive protein increased April 9, excrutiating pain in Left foot. April 10, excrutiating pain in right foot. April 11, pain... Read more
April 9, excrutiating pain in Left foot. April 10, excrutiating pain in right foot. April 11, pain in both feet. Can hardly walk, all of a sudden out of nowhere! Went to Urgent care April 12th. Unknown. Podiatrist April 14th, Unknown. Another Podiatrist April 21st, Unknown, but orders X-Rays. Show nothing. Walking like a crippled person in pain. Again, all of a sudden out of nowhere!. Sunday, April 25, excrutiating pain, weight-bearing on right foot. Husband carries me to the car and drives to ER . NOTE: All physical exams did not cause pain when manipulating joints.
56 2021-05-02 peripheral swelling Joint swelling and pain in fingers and feet since vaccination day. Joint pain ( intermittent) in kne... Read more
Joint swelling and pain in fingers and feet since vaccination day. Joint pain ( intermittent) in knees since vaccination day Headache for five days Nausea for the days
56 2021-05-04 lymph node swelling terribly sick; terrible headache; aches started/ Everything was hurting; her left arm where she got ... Read more
terribly sick; terrible headache; aches started/ Everything was hurting; her left arm where she got the vaccine, under her arm, her lymph nodes swelled to the size of a little kid's ball; Part of her left breast near the swollen lymph node was sore; back was hurting; couldn't even sleep with her ankles together in bed because she was hurting; couldn't even sleep with her ankles together in bed because she was hurting; low grade fever/ feeling feverish; congestion; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 56-years, at single dose in left arm on 05Apr2021 11:30 (Lot Number: ER8735) for covid-19 immunisation. The patient medical history was not reported. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) also at age of 56-years, at single dose in left arm on 15Mar2021 13:45 (Lot Number: EP7534) for covid-19 immunisation. The patient had no side effects from the first covid-19 vaccine. Concomitant medications included ongoing estradiol and atenolol; montelukast sodium (SINGULAIR); ongoing rosuvastatin calcium. The patient reported that her side effects were terrible. She felt fine after her vaccine but that night on 05Apr2021, she became terribly sick. She had a terrible headache. Then aches started. In her left arm where she got the vaccine, under her arm, her lymph nodes swelled to the size of a little kid's ball, liked a toddler sized ball. She was sure it was the lymph node. Part of her left breast near the swollen lymph node was sore. It was just really terrible. Her back was hurting. Everything was hurting. She couldn't even sleep with her ankles together in bed because she was hurting. She was totally miserable. She also had a low-grade fever. She thought she would feel better the next day but her symptoms went on the whole week. As far as she could tell her symptoms were over on 10Apr2021. By 10Apr2021, she didn't feel bad anymore and the lymph nodes under her arm had gone down. And she had been taking Tylenol (took 2 tablets almost every time) and different things for her headache and feeling feverish. She had to take something for her aches. She had no idea her symptoms were going to continue that long. She also took Mucinex because she had congestion and she wanted to try and dry herself up. She had called her primary care doctor and was told to go to the emergency room but she never went. She was already miserable enough, she didn't want to sit in the emergency room. The patient did not take vaccines and probably hadn't had a vaccine since she was a teenager and that was a long time ago. She has no known allergies to medications. It was reported that the adverse events did not result in a visit to Emergency room or Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome for event congestion was recovering, while for remains event was recovered on 10Apr2021. No follow-up attempts are needed. No further information is expected.
56 2021-05-05 lymph node swelling Shortness of breath (decreased peak flow and fev for 10 days as of time of report), brain fog, fatig... Read more
Shortness of breath (decreased peak flow and fev for 10 days as of time of report), brain fog, fatigue, enlarged lymp nodes still exist as of time of report.
56 2021-05-05 swelling face a red, raised welp on forehead with a complaint of headache. Patient also complained of being dizzy ... Read more
a red, raised welp on forehead with a complaint of headache. Patient also complained of being dizzy and had fatigue for the next 24 hours. Took tylenol and Benadryl
56 2021-05-08 peripheral swelling, lymph node swelling 48 hours after injection I became sick very tired slept for 2 days and then I felt like I had the fl... Read more
48 hours after injection I became sick very tired slept for 2 days and then I felt like I had the flu I was very fatigued and my whole body aches and I had pain besides my chronic pain that has stayed shortness of breath countinues cough swelling of feet that just started recently my suger out of control April 23rd had pre-op testing my sugar was at 500 I had MRSA I had a quiet heart attack as well as a constant egg going down my left side where I had injection that is constantly aching and also pain in my chest and underneath my rib cage on the left side. I did go to the emergency room two weeks after I had my shot because the doctor my primary could not give me any answers and I questioned him about the second shot and he had no answers. My surgery has been canceled. My back surgeon mentioned something about my lymph nodes that they were swollen which is what he thought was water build up in my left side of my neck during an MRI he then did a CAT scan checking to see what that was and he mentioned my lymph nodes. I originally went for MRI because I had had several falls into surgeries in my neck and he was checking to see if anything collapsed and that's when he found through the CAT scan that my lymph node was enlarged. I still carry the cough heart palpitations and fatigue and I have put off the second shot but nobody can give me answers so I did research and saw about the MRSA the diabetes and as well as the swollen lymph nodes
56 2021-05-09 peripheral swelling, swelling face weakness, runny nose, diarrhea, inflammation, chest pains, anxiety, swollen face, fingers, brain fog... Read more
weakness, runny nose, diarrhea, inflammation, chest pains, anxiety, swollen face, fingers, brain fog,
56 2021-05-09 peripheral swelling Pfizer-BioNTech COVID-19 Vaccine EUA Extreme joint pain, nausea, dizziness, swelling in hands, rapid... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Extreme joint pain, nausea, dizziness, swelling in hands, rapid heart rate, headache, injection site pain, very tired
56 2021-05-10 anaphylactic reaction anaphylaxis; headache with numbness; headache with numbness; blurred vision and nausea from headache... Read more
anaphylaxis; headache with numbness; headache with numbness; blurred vision and nausea from headache; blurred vision and nausea from headache; has been trapping food since in her throat; had irritation in her throat; coughing; coughing; off balance; couldn't see straight; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6207), via an unspecified route of administration, administered in Left Arm on 18Mar2021 10:30 (at age of 56 years old) as single dose for COVID-19 immunisation. Relevant medical history included: Asthma, immune problems, upper respiratory stuff, all ongoing; Her Diagnosed allergies include iodine fish, Propofol, and preservatives, sleep apnea, had COVID in Jan2021, and had a cough (Jan2021) from that. There were no concomitant medications. The patient previously took iodine, propofol and had allergies. Patient took first dose on 18Mar for reason that patient has lost all allergies that cannot be detected by blood work. After first short she was told to wait an extra 15 mins not vitals taken she can leave a felt like a specimen unpaid but paying with life. Patient started coughing while everyone watched her so she said she better take Benadryl cause she doesn't wanna die. Patient left had off balance couldn't see straight. She was the one that had all side effects from vaccine as well as COVID signs. She had research medicine/food that cause her to have anaphylaxis. Patient found same ingredients in vaccine but food and drug said it ok. Patient was an experiment. She need to no from your board it is ok for me to take 2nd vaccine. Patient should be getting paid. Her doctor making it seem it up to her she gotta go out and get and epi pen she cant afford. In running out of gloves and mask. The patient experienced Anaphylaxis, has been trapping food since in her throat, headache with numbness, Cough, blurred vision and nausea from headache, all on 18Mar2021. Caller has been coordinating with the CDC by email. Since day one she had a bad reaction to the COVID vaccine. This has been going on a month now. The CDC advised her not to get the second shot. She has went back and forth with the doctor. She had anaphylaxis from the vaccine. Her throat closed. She had irritation in her throat. She has been trapping food since in her throat. This has been since the anaphylactic reaction. She has to chew her food as fine as possible. She tries not to eat that much. This is still the same. It hasn't improved or worsened. She has also had a headache with numbness that is pretty much 24 hours a day. This started right after. She really felt it the next day. She tried to take Tylenol for four days, three times a day, and nothing happened. It was not going away. Her doctor also put her on a migraine medication, but it didn't work either. The headache has worsened over time. No medication is helping, and the doctors are confused. The migraine medicine is not helping. Her pressure is going up and down. She is wondering if she needs an emergency echo to see what is going on. She is still having bad effects. No doctor knows what to do. She has been to a lung specialist. Her cough just keeps getting worse. The cough started to get worse after the vaccine. She had COVID in Jan2021, and had a cough from that, but the vaccine made it worse. It is a ruff cough. She is on cough suppressant medication. Caller did not have a prescribing doctor. She got it at the hospital. She figured that was the safest, and since she is a patient there they emailed her because she was eligible to get it. She is mostly calling because the doctors don't know how to help. She is about to pass out from this headache. She is even losing vision from the headache. She feels like she is going to have a heart attack before her time. They are trying to figure out why her head is hurting. They do not think it is a migraine. Her headache is a 9/11 or a 10/12. She feels like after the vaccine she has been chemically off balance. She wants to get her thyroid checked too. Mostly because her food is getting trapped in her throat. Her throat is irritated and hoarse. The headache has given her blurred vision, and a felling like she is going to throw up. She feels off balance from the blurred vision. Caller had difficulty seeing information on Tylenol and Nurtec. She asked her husband to help. They cannot read the lot on the Tylenol. She has been to so many specialists to try to find answers, and no one has a clue. She saw on Pfizer's paperwork that she needs to reach out to a immunologist. Her allergist had no clue. From the world trade centers falling she has ongoing issues from that. She has sleep apnea, allergies, asthma, etc. She spent 30 minutes being monitored at the hospital. She had started coughing. Her husband said she needed water. She always carries Benadryl with her. Finally she felt like she needed to take her Benadryl. It saved her. She knows the Benadryl probably won't work forever, but she cannot afford an epi Pen. Time of Onset (24 hours clock): right after vaccine (18Mar2021). All events require a visit to Physician Office. She didn't have to go the ER. She was lucky with the Benadryl. She takes Benadryl with her everywhere even to restaurants. No Prior Vaccinations (within 4 weeks). Treatment received for coughing, headache with numbness, blurred vision and nausea from headache. The outcome of the event has been trapping food since in her throat, had irritation in her throat, headache with numbness, blurred vision and nausea from headache was not recovered, for other events was unknown.
56 2021-05-10 swelling 56 yo Female had a symptoms of anxiety and hyperventilation syndrome ( likely associated anxiety) .... Read more
56 yo Female had a symptoms of anxiety and hyperventilation syndrome ( likely associated anxiety) . She has prior history of anaphylaxis to bee sting and treated in the hospital 1-1/2 years ago. She also had allergy to oral Lipitor (?(verbal history) oral mucosal swelling but not anaphylaxis) She also has history of anxiety. She did not indicate any Only meds include Lipitor. She was sleep deprived ( 5 hrs of sleep ) last night . She received her 1st Pfizer IM dose at 11:17 am and 18 minutes later ( 11:35 am) called the attention of the nurse that she had numb sensation of her lips and peri oral area, ?itchy with burning sensation of her throat?, but able to breath well without tongue or throat tightness. She admitted she felt nervous , and felt transient chest tightness . She continued to be alert and oriented, appeared pink , no near syncope but was breathing deep and fast ( 22/min) with sigh breaths. She was alert , oriented to place and person but lightheaded. No focal weakness or deficits, but her lips felt numb with paresthesia , mild localized angioedema of lips, tongue appeared normal with Mallampati score 2. Initial vital signs showed stage 2 hypertension , 144/88 mmHg ( MAnual BP) , HR 63/min SpO2 97-98%, RR22/min, with occasional sigh breaths. She did not develop stridor or hoarseness throughout observation. She was moved to a Gurney, HOB 45 degrees , transferred from observation area to another area for close monitoring. VS were repeated every 10 minutes , BP ranged from 137/78 to 142 /84 mmHg, SpO2 98% on room air, RR 20-22/min. HR 60 to 63/min . On exam , remained alert and oriented to time,place and person, verbalized chest tightness at the onset ( 11:35am) resolved after knowing she had no throat tightness, no stridor , her Lungs were clear to auscultation. She did not develop stridor , appeared comfortable , with normal voice tone and clear speech ; her lips had subtle angioedema ( subjectively felt thick ) but did not progress, tongue normal on exam without angioedema. Eye exam normal, no eyelid swelling. Chest clear breath sounds to auscultation, no wheeze, Heart RR,normal resting HR , no murmur , good and equal radial pulses. Distal Upper extremities were initially cold to touch , pink, but eventually became warm and well perfused. Due to localized sensation of numbness of lip with subtle angioedema, She was kept under close observation until full recovery. We deferred epipen auto injection since she did not progress to anaphylaxis, had no stridor, no throat tightness , resolved ? burning sensation? of throat, no hypotension, no wheeze and with improved sense of well being within the subsequent 30 minutes and 60 minutes of observation . She indicated that her experience with bee sting was worse, felt better today .She was given diphenhydramine 25 mg PO which she took without difficulty. She was able to sit up, brought to the restroom to urinate accompanied by female EMTs, was transported via wheelchair and upon return insisted on walking without difficulty, had normal gait. She allowed to rest for another 20 minutes ( total of 80 minute observation. She was able to stand up, observed to have normal gait , was escorted to her car with no further incident. She verbally agreed to have her condition reported to VAERS. Since she was given Benadryl 25 mg PO which she drank with water without difficulty. She was not allowed to drive her car, and her mother picked her up form the vaccine clinic. VS upon discharge : BP with mild hypertension 138/82mmHg, HR 62/min, RR20/min, Sp02 98% on room air. She was advised to monitor symptoms at home ( based on Pfizer handout guidelines which was discussed with her). If she has similar symptoms of anaphylaxis ( similar to her bee sting 1-1/2 year ago ) advised to give herself Epipen autoinjector which she has at home, to inform her Mom , and call 911. Follow up phone call done 6 hours after the incident , she answered her cell phone, had normal voice tone without stridor and verbalized she is feeling better , no recurrence of symptoms , no other concerns. She was advised to follow up with her PCP for further advise regarding BP control. Based on above events , we discussed with her to avoid mRNA COVID 19 vaccine and discuss alternative COVID 19 vaccine with her PCP. She verbalized understanding .
56 2021-05-10 lymph node swelling "ache" in the middle finger of her hand; she "doesn't feel much" as if her arm is numb; she cannot d... Read more
"ache" in the middle finger of her hand; she "doesn't feel much" as if her arm is numb; she cannot do much with that arm, her hand is also "stiff"; hurting ang burning when she moves her arm; swollen gland/lymph between her shoulder and neck, near the bone; she feels the "pressure" in that arm; "ache and a bruise" where the vaccine was injected; "ache and a bruise" where the vaccine was injected; This is a spontaneous report from a contactable consumer (reported herself). A 56-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) administered in left arm via an unknown route of administration, on 20Apr2021 as SINGLE DOSE for covid-19 immunization. Historical vaccine included first dose of BNT162B2. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient stated after receiving second dose on left arm patient had "ache and a bruise" where the vaccine was injected, "but it was gone the next day". On 21Apr2021, patient had experienced "swollen gland/lymph between her shoulder and neck, near the bone" on the same side she received the injection, plus it is "hurting ang burning" when she moves her arm. She specified her left arm "is hurting" all the way to her "shoulder" and the pain extends to "the back of that shoulder". She said she feels the "pressure" in that arm but when she "pinches it", she "doesn't feel much" as if her arm "is numb". She mentioned she cannot do much with that arm, her hand is also "stiff", and she has difficulty using it. She added yesterday, she started to have "ache" in the middle finger of her hand. She asked if her symptoms were reported as side effects to the vaccine. The outcome of the events were unknown. No follow-up attempts were needed; Information about lot/batch number cannot be obtained.
56 2021-05-10 swelling 1ST DOSE PFIZER VACCINE REACTION: April 6: Received first dose of Pfizer vaccine. April 6-10: ... Read more
1ST DOSE PFIZER VACCINE REACTION: April 6: Received first dose of Pfizer vaccine. April 6-10: Felt sick with mild flu-like symptoms. Better each day after that, and eventually back to normal. April 23: 17 days after vaccine began to feel unwell. April 24: Face, neck, and chest were quite red, not feeling well. April 25: Woke up feeling awful, darker and deeper red from head to knees, face and neck puffy/swollen. Exhausted, heavy eyes and head, slight wheeze at night. Skin on face and neck slightly thickened, in some places, and warm to touch. Felt like heart was pounding, but don't think pulse was elevated. Took Benadryl (3 tablets in 24 hours), antacid, and felt slightly better. April 26: Still red, but lighter shade. Redness in face and body faded more with each day. April 28: Saw a dermatologist who suggested this was DRESS syndrome. Asked if lab tests were necessary/useful; he said not at this time. May 1: Looking pretty normal.
56 2021-05-11 lymph node swelling Swollen lymph glands; fatigue; soreness behind her eyes; light sensitive; Arm pain; chills; headache... Read more
Swollen lymph glands; fatigue; soreness behind her eyes; light sensitive; Arm pain; chills; headache; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 0.3 ml injection, Lot#: EW0162, Expiration Date: 31Jul2021) at single dose on 18Apr2021 12:50 in left upper arm muscle for COVID-19 immunization. The first dose was on 28Mar2021 (Expiry Date: 31Jul2021) at 1400 or 1500, and experienced shingles, arm pain, headache, fatigue and some chills. Medical history included shingles in the past, with the second vaccine patient had just cleared up from the shingles. Patient clarified shingles was pretty cleared up, it was not active and doctor said she could get the second vaccine. There was on other products taken. Prior vaccinations (within 4 weeks) was no. Patient experienced swollen lymph glands on 20Apr2021; arm pain, chills and headache on 18Apr2021; fatigue and soreness behind her eyes on 19Apr2021. Days later she got the second vaccine, patient was having regular side effects of arm pain, fatigue, and swollen lymph glands. She had gotten shingles before, and sometimes it popped up at different times. She didn't have other underlying condition like some people who had immunodeficiencies or arthritis. The arm pain after first and the second vaccine started the day of the vaccine. That arm pain from the second vaccine woke her up at 3am, it was so bad. It seemed to subside more quickly. Today it's still there, but not as bad. It was almost not noticeable. Patient felt more fatigue after the second vaccine today and yesterday. She felt more fatigued today and clarified it was persisting as of now. The lymph glands felt tender in her neck, which started today and was ongoing. Patient also had chills after the second vaccine, but was improving. Patient also had a headache after the second vaccine, which resolved today. It also felt sore behind her eyes. Patient stated it had to happen with her in the past as a flu symptoms. They were light sensitive, and if she moved them to the right and left she had soreness behind her eyes. This started yesterday and was ongoing. She did not have the soreness behind her eyes with first dose. She was not sure if it's associate with the headache. The outcome of events arm pain and chills was recovering. The outcome of event headache was recovered on 20Apr2021. The outcome of rest events was not recovered. No follow up attempts are needed. No further information is expected.
56 2021-05-11 peripheral swelling About an hour after the 2nd dose, I started to feel faint/dizzy/tired/nauseous. After a day, I noti... Read more
About an hour after the 2nd dose, I started to feel faint/dizzy/tired/nauseous. After a day, I noticed arthritic pains in both shoulders. The left arm joint pains went from shoulder to finger tips (prior, I was being treated for stiff finger joints in my left hand). Since the shot, most of the problems have gotten better, but I'm still left fatigued most of the time, and have slightly increased swelling in my left hand fingerjoints.
56 2021-05-11 swelling face Received second dose Pfizer vaccine today. Post vaccine 30 minutes patient reported "swelling of to... Read more
Received second dose Pfizer vaccine today. Post vaccine 30 minutes patient reported "swelling of tongue and lips feeling puffy/tingly". Denies difficulty swallowing or breathing. Taken per wheel chair to ED for evaluation. The patient is a 56 yo F presenting with possible vaccine reaction. The patient received her 2nd dose of Pfizer vaccine today. Approximately 30 minutes after vaccine she had some lip and tongue tingling and felt like her throat was "tight". She denies difficulty swallowing, breathing, rash, nausea or vomiting. She has an epi-pen which she did not use. Denies any complications with 1st dose. Allergies: Sulfa antibiotics, Ciprofloxacin, Eggs or egg-derived products, Milk-related compounds, Nut [peanut-containing drug products], Other (non-food), Soybean-containing drug products, Zithromax [azithromycin dihydrate], Biaxin [clarithromycin], Cephalosporins, Levaquin, and Penicillins No evidence of anaphylaxis. Hemodynamically stable. Patient re-evaluated and feels at baseline. Discussed return precautions Received benadryl 25mg PO, famotidine 20mg PO, and solu-medrol 125mg IV in ER
56 2021-05-11 swelling 4 days after 2nd vaccine dose woke up with a bruising feeling on face and when she came home she not... Read more
4 days after 2nd vaccine dose woke up with a bruising feeling on face and when she came home she noted red and swelling on right cheek. Improved with some topical corticosteroids and antihistamine and then seemed a bit on the left later that night.
56 2021-05-15 guillain-barre syndrome On 5/6/21, patient developed BLE progressive weakness, numbness/tingling, then progressed to BUE num... Read more
On 5/6/21, patient developed BLE progressive weakness, numbness/tingling, then progressed to BUE numbness/tingling weakness, presented to Hospital 5/8 ED, discharged, then presented to 5/9 Hospital, eventually diagnosed with AIDP / GBS. Given IVIG 5d course through 5/14. Required mechanical ventilation 5/14. Pending ongoing management at Hospital Neurologic Intensive Care Unit
56 2021-05-16 swelling face I informed nurse of present allergies. I was taken closer to side door where paramedic waiting in pa... Read more
I informed nurse of present allergies. I was taken closer to side door where paramedic waiting in parking lot. I received the vaccine and suddenly I developed blurred vision and became dizzy. My face and throat began to swell up. I could not speak. I was taking in ambulance to hospital. BP 180/120 I was held in ER for 6 hours and release after six hours. I was give IM Benadryl while in ambulance
56 2021-05-17 lymph node swelling I was given the Pfizer Vaccine at the hospital on both separate occasions. I had an adverse reactio... Read more
I was given the Pfizer Vaccine at the hospital on both separate occasions. I had an adverse reaction w/ the second vaccine - about 4 to 5 days after given the shot, I developed a large swollen gland the size of a golf ball on the right side of my neck, also the glands under my right arm were swollen as well. It was tender and painful. The shot was administered on my right arm.
56 2021-05-19 peripheral swelling She got her vaccine, her arm was swollen last night. When she woke up this morning the area of the ... Read more
She got her vaccine, her arm was swollen last night. When she woke up this morning the area of the vaccine was bubbling. It looks like fluid. It started out as a little bit but it's gotten worse and the area is getting worse and the skin is bubbling and swelling. It is warm to touch and itching, and does not want to touch it. She went to the pharmacy where she got the vaccine and they told her to give us a call.
56 2021-05-19 swelling, lymph node pain, lymph node swelling When first shot was given in left arm, within a week left side of neck developed a swollen lymph whi... Read more
When first shot was given in left arm, within a week left side of neck developed a swollen lymph which you could visibly see swelling. When 2nd COVID Vaccine was given it was given 4/26/21 in the right arm; back of neck became swollen within a couple of days stomach started hurting. On 5/12/2021 I was admitted into the hospital due to severe abdominal pains; it was discovered to be the result of swollen lymph nodes in the stomach. Currently taking large doses of Ibuprofen.
56 2021-05-20 lymph node swelling 6 hours after injection developed swelling of lymph nodes in neck and throat. saliva glad became sw... Read more
6 hours after injection developed swelling of lymph nodes in neck and throat. saliva glad became swollen and ruptured. Symptoms resolved within two hours
56 2021-05-22 lymph node swelling Lymphadenopathy to left armpit - with pain on day 1 , mild warmth, small pea sized nodule palpable a... Read more
Lymphadenopathy to left armpit - with pain on day 1 , mild warmth, small pea sized nodule palpable at 4:03 am . Also had nausea, headache and sharp electrical type sensation to my lower jaw bone that radiated left to right, soreness to left arm of injection. Day 2 only swollen lymph nodes with change in size to kidney bean size and pain still present. Day 3 left side lymph node with 2 sites one pea sized the other walnut sized both painful to touch and noticeable when moving arm during activity. Day 4, both sites still present same sizes and tenderness continues along with mild discomfit during movement with activities.
56 2021-05-25 lymph node swelling Arm pain, large, red, itchy rash in area of the vaccination. Swollen supraclavicular lymph node on ... Read more
Arm pain, large, red, itchy rash in area of the vaccination. Swollen supraclavicular lymph node on right side.
56 2021-05-25 lymph node swelling Symptoms of full-body chills; swelling of lymph nodes; headache; nausea; This is a spontaneous repor... Read more
Symptoms of full-body chills; swelling of lymph nodes; headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received second dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number not reported) (non-pregnant at the time of vaccination) via intramuscular route of administration on 23Feb2021 15:15 in arm left as single dose for COVID-19 immunisation. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included hypertension. Concomitant medication included escitalopram, alprazolam, amlodipine taken for an unspecified indication. Historical vaccine included first dose of BNT162B2 on 03Feb2021 in the right arm at single dose for COVID-19 immunisation. No COVID prior vaccination. The patient was not tested for COVID post vaccination. On 24Feb2021 04:00, the patient experienced full-body chills, swelling of lymph nodes, headache and nausea. Outcome of the events were not recovered. Follow-up attempts are completed. No further information was expected.
56 2021-05-26 peripheral swelling, swelling face Missed second dose of the Pfizer COVID vaccine; left arm swollen; face swollen and whelped up; can't... Read more
Missed second dose of the Pfizer COVID vaccine; left arm swollen; face swollen and whelped up; can't use her left arm like she used to; started losing her voice; asthma attack: coughing and wheezing, became short of breath; As per agent, caller reported shoulder and wrist hurting; asthma attack, swelling of arm and difficulty using her arm and itchiness.; caller reported shoulder and wrist hurting; asthma attack, swelling of arm and difficulty using her arm and itchiness.; As per agent, caller reported shoulder and wrist hurting; asthma attack, swelling of arm and difficulty using her arm and itchiness.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that the 56-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 17:00 (Batch/Lot Number: ER8731, Expiry Date: 11Apr2021) as 1st dose, single for covid-19 immunisation. Medical history included covid-19 from Nov2020 to Dec2020 (She says she got COVID around Thanksgiving. She says she is not sure when she recovered but that it was within 2 weeks. She says it was somewhere in the first or second week of DEC2020), ongoing asthma when she was 28 she thinks, ongoing chronic obstructive pulmonary disease (COPD, She says she is not sure when this condition started because they are off and on with it. She says they started treating her 3 or 4 years ago for it.), ongoing high blood pressure (She says they started treating her about 2 maybe 3 years ago for this condition.), ongoing hypersensitivity: allergic to penicillin, sulfa, aspirin, iodine, CAT scan dye, roaches, tree pollen, grass pollen, cat and dog dander, roach droppings, everything, dust mites since in her 30's: for about 20 some years, ongoing arthritis condition since about 5 or 10 years ago. Concomitant medications included fluticasone (FLUTICASONE) nasal spray at 50 mcg, 2 squirts in each nostril once a day for allergies for over 10 years; meloxicam oral at 7.5 mg as needed (2 tablets by mouth every with meals)(She says she doesn't have to take it every day); omeprazole at 40 mg every day for acid reflux for over 10 years; sertraline at 100 mg, 2x/day for depression (When asked how long she has been taking this she says it hasn't even been a year yet; about 6 or 9 months.); furosemide oral at 40 mg, 1x/day for over 20 years for buildup of fluids; azelastine nasal spray via Nasal at 1x/day (spray in nose once day in each nostril) for allergies; montelukast sodium Singulair at 10 mg, 1x/day for asthma and allergies for over 20 years; amlodipine at 5 mg, 1x/day for high blood pressure 2, maybe 3 years ago; potassium at 20 meq, daily to put the potassium back in that the water pill takes out for over 20 years, Trellogy for about 2 years she thinks and all ongoing. The patient experienced asthma attack: coughing and wheezing, became short of breath (medically significant) on 08Apr2021 with outcome of recovered on 13Apr2021 , as per agent, caller reported shoulder and wrist hurting; asthma attack, swelling of arm and difficulty using her arm and itchiness on 08Apr2021 with outcome of recovered, left arm swollen on 09Apr2021 with outcome of unknown , started losing her voice on 08Apr2021 with outcome of recovered on 13Apr2021, face swollen and whelped up on 09Apr2021 with outcome of not recovered , can't use her left arm like she used to on 08Apr2021 with outcome of not recovered , missed second dose of the pfizer covid vaccine on 29Apr2021 with outcome of unknown. The outcome of the event itchy was recovered on 14Apr2021. The outcome of the event wrist started hurting was recovered on 08Apr201. The outcome of the event shoulder started hurting was not recovered. The clinical course was reported as follows: the consumer developed a severe allergic reaction after the first dose of the pfizer covid vaccine. As per agent, caller reported shoulder and wrist hurting; asthma attack, swelling of arm and difficulty using her arm and itchiness. advised by hcp not to get 2nd dose what can she can do get fully covered. She says she wish she had know this back when she had the shot. She says on 08APR2021 she had the first shot and had a severe allergic reaction to it. The consumer says she had a severe allergic reaction. She elaborates and says her shoulder started hurting and it went down to her wrist, then all of the sudden she was itchy, she started losing her voice like her voice is doing right now, and she ended up having an asthma attack, the next day her arm swelled up, and her face swelled up and whelped up. For her shoulder she says she can't really do hardly anything with that arm. She says she means her left arm and that she is left handed. She says if she puts too much weight on it is sore. For the itchiness she says that lasted for over a week but on Tuesday she went to her primary care provider and they gave her a prednisone shot which helped a whole lot. She says her breathing went back to normal and her voice came back. The consumer does not know the dosage of the prednisone; she says it was Solu-Medrol and that's all she knows about it. She says quietly that she went to the doctor on 13Apr2021. The consumer says she forgot to say that she was coughing and wheezing too. She confirms that this was a part of the asthma attack and that she also became short of breath. She says all of that was on 08APR2021. She says the issues she is having with her voice right now is from something else. No further information provided. The consumer clarifies that when she lost her voice on the 08Apr2021, that ended 13Apr2021 and she recovered completely from that. She says her left arm is sore but not swollen. She says the swelling lasted for over a month. She is not sure the exact day it ended and says the only effect is she can't use her arm like she used to. For the face swollen and whelped up she says it goes down, the welts go away, and they come back in the morning. She confirms it is ongoing and persisting. She says the shoulder started hurting right after the shot which was at about 4:00pm or 5:00pm. She says the wrist started hurting about 5 minutes after the shoulder did. She says the itchiness occurred about 5 or 10 minutes after the shot. She says that everything occurred between 4:00pm and 5:00pm within 5 to 10 minutes after the shot. She confirms that by everything she means everything that occurred on 08Apr2021. She says she noticed her left arm was swollen, the next day in the afternoon and that her face was swollen and whelped up the next day, in the morning. The consumer says that 08APR2021 was her first dose and that she hasn't had the second shot. She says she was supposed to go back on the 29Apr2021 to take the second shot but didn't get it. The caller says her doctor told her not to get it. She asks does she need to get the second shot and what can she do to get fully covered. She says she takes just the normal medicine that she always takes. Vaccination Facility Type: The Pipkin Building. She says it was a pop-up station. No Vaccine administered at Military Facility. She says the military was there. Additional Vaccines administered on same date of the Pfizer suspect was none. AEs require a visit to not emergency Room but Physician Office and She says she went to the doctor because she thought she was having an allergic reaction to the COVID shot. She confirms she went to the doctor on 13Apr2021. Prior Vaccinations within 4 weeks (List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s)) was none. AE(s) following prior vaccinations: She says no, not to vaccines. No further information provided.The caller denies being sick at the time of vaccination. Family Medical History relevant to AE(s) was none. She says she is the sickest person. Relevant Test was none.
56 2021-05-26 peripheral swelling Blood clots have developed in both legs. Started with swelling in feet and ankles and went to the d... Read more
Blood clots have developed in both legs. Started with swelling in feet and ankles and went to the doctor. Ultrasound showed clot in artery behind left knee and second clot in right calf.
56 2021-05-28 lymph node swelling has some little nodules floating around that she can feel; she experienced swollen lymph nodes in he... Read more
has some little nodules floating around that she can feel; she experienced swollen lymph nodes in her neck. She said they are still swollen, moving a little.; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3248) via an intramuscular route of administration on 25Jan2021 in left arm as single dose for COVID-19 immunization. Previously the patient included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3248) via an intramuscular route of administration on 06Jan2021 at 02:10pm on left arm as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 27-Jan-2021 the patient reported that she experienced swollen lymph nodes in her neck. She said they were still swollen, moving a little. Caller wanted to know how long it takes for them to go away. The caller explained that the swelling had improved and was not as bad and not as tender to the touch as it was previously. However, on an unknown date in 2021 she felt nodules all up in there. Her lymph nodes were originally swollen on both sides her neck and now it seems to be swollen on one side, she doesn't really know. Caller made the comment that she wished they would make the Vaccine Record Card fit in a regular wallet. The caller mentions the writing is so tiny and that she needed to get in better light. Callers believed the beginning letter of the Lot number was an E or it could be an F. She thinks it was an E. It was mentioned that the patient did not receive any other products, had no history and no investigation was done, she did not require emergency Room and physician Office visit, no prior vaccinations (within 4 weeks) was done, and no relevant test were done. The outcome of has some little nodules floating around that she can feel was unknown and Swollen lymph nodes was recovering. Follow-up attempts are completed. No further information is expected.
56 2021-05-29 swelling Swelling & tenderness on left collarbone (same side as vaccine). Symptoms of tenderness subsided af... Read more
Swelling & tenderness on left collarbone (same side as vaccine). Symptoms of tenderness subsided after several days. Swelling was diminishing each day. Slight swelling in collarbone still remains approximately 3 weeks later.
56 2021-05-31 lymph node swelling Since 1 week after my first Pfizer Covid19 vaccine, I have had dark circles under my eyes, swelling ... Read more
Since 1 week after my first Pfizer Covid19 vaccine, I have had dark circles under my eyes, swelling under my eyes and swollen glands in my neck (beneath both ears)
56 2021-05-31 peripheral swelling raised bumps under both arms; Cough; This is a spontaneous report from a contactable consumer, the p... Read more
raised bumps under both arms; Cough; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration, in the right arm on 11Mar2021 (at the age of 56-years-old) as a single dose for COVID-19 Immunisation. Medical history included asthma, sinus issues and sore throat. Prior to the vaccination, the patient was not diagnosed with COVID-19 and tested negative for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included doxycycline (Manufacturer unknown) for an unspecified indication. The patient was allergic to amoxicillin. On 12Mar2021, the patient experienced raised bumps under both arms. It was reported that the bumps looked like hives but they're not itchy for the patient. It was reported that these bumps started to appear the day after the shot. On an unspecified date in Mar2021, the patient had cough but unsure if it's from my sinus cold or from the vaccine. The patient did not receive any treatment for the events. The clinical outcome of the raised bumps under both arms was not recovered and the outcome of cough was unknown. Information about lot/batch number cannot be obtained. No further information is expected.
56 2021-05-31 swelling face Milder facial numbness and swelling; Milder facial numbness and swelling; extreme fatigue; This is a... Read more
Milder facial numbness and swelling; Milder facial numbness and swelling; extreme fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL0142, expiry date:not reported), dose 2 via an unspecified route of administration on 04Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EH9899, expiry date: not reported) via an unspecified route of administration on 14DEC2020 as SINGLE DOSE for covid-19 immunisation and experienced flushed swollen face, thick swallowing, mild facial numbness, gastrointestinal pain, nausea, extreme fatigue and mild joint pain. All resolved 2 days post 1st vaccine dose except mild facial numbness. The patient medical history was not reported. Concomitant medications included estrogens conjugated (PREMARIN) .625 mg daily for an unspecified indication for the past 18 years and ongoing, cetirizine hydrochloride (ZYRTEC) 5mg daily for an unspecified indication for more than 10 years and ongoing, levothyroxine sodium (SYNTHROID) 50mcg taken for an unspecified indication from Oct2020 and ongoing, multivitamins and calcium for the past 28 years. On an unspecified date, the patient experienced milder facial numbness and swelling, extreme fatigue. The outcome was events was unknown. No follow-up attempts are possible. No further information is expected.
56 2021-05-31 swelling face bottom of face is still swollen- Feels like there's liquid in it; Had plastic surgery and those scar... Read more
bottom of face is still swollen- Feels like there's liquid in it; Had plastic surgery and those scars are redder today; headache; arm was hurting; swollen face/ swelling in face/ bottom of face is still swollen- Feels like there's liquid in it; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 30Jan2021 (Batch/Lot number was not reported) (at the age of 56-years-old) as 1STDOSE, SINGLE for covid-19 immunisation. Medical history included facial surgery/face lift on Nov2020 and plastic surgery from an unknown date and unknown if ongoing. The concomitant medications were not reported. The patient previously took botox on Nov2020. The patient stated that had a face lift in Nov2020 and her face was slow to heal. Patient reported a swollen face after receiving the first dose of the pfizer covid 19 vaccine along with a headache on 30Jan2021. Patient wanted to know was the swollen face because her facial surgery had not healed or was it a reaction to the vaccine. On Sat- 30-40 min later, patient had swelling in face and her arm was hurting yesterday- headache today and bottom of face was still swollen and Feels like there's liquid in it. In Nov caller had plastic surgery and those scars were redder today. Patient wanted to know what she could take for her headache that she thought was related to the pfizer covid 19 vaccine. The patient was enquiring about any information regarding the use of the pfizer-bioNTech covid-19 Vaccine in people who have cosmetic fillers or Botox. Patient stated that she never had anaphylaxis to a vaccine and she had face lift surgery in Nov. Wanted to know if she had an allergic reaction to the vaccine or if it was from the surgery and she was not fully healed. Also stated that her left arm was hurting yesterday but was fine today. Outcome of the events swollen face/swelling in face/ bottom of face is still swollen- Feels like there's liquid in it and headache was not recovered. Outcome of the events arm was hurting, bottom of face is still swollen- Feels like there's liquid in it and had plastic surgery and those scars are redder today was unknown. Information on the lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
56 2021-05-31 swelling Numbness of the area where the vaccine was given, ganglion under the armpit, swelling from shoulder ... Read more
Numbness of the area where the vaccine was given, ganglion under the armpit, swelling from shoulder to chest, redness of the arm eventually and that goes down to the forearm.
56 2021-06-01 lymph node swelling, c-reactive protein increased muscle pain; headaches; swollen glands; the arm where the vaccine was injected could not be lifted a... Read more
muscle pain; headaches; swollen glands; the arm where the vaccine was injected could not be lifted and I still have difficulty lifting it; stiff neck; pain it causes in my back, legs, neck; lack of strength making it difficult for me to sleep; lack of strength making it difficult for me to sleep; The levels my doctor sees for the CReactive protein QT test have doubled.; 4 days with fever; This is a spontaneous report from a contactable consumer (patient herself). A 56-year-old female patient received BNT162b2 (BNT162b2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection) via an unspecified route of administration on 07-APR-2021 11:30 (Lot number: GW0151, Expiry date: Unknown) as 2nd dose, single dose for COVID-19 immunisation. Medical history included Ankylosing Spondylitis, Hypothyroidism, uveitis. The patient previously received first dose of BNT162b2 on 07-MAR-2021 11:45 (Lot number: EN6207, Expiry date was unknown) for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient was not diagnosed with COVID 19 since the vaccination. Concomitant medications included levothyroxine sodium (SYNTHYROID), folic acid (MANUFACTURER UNKNOWN), methotrexate and adalimumab (HUMIRA) for an unknown indication. On 08-APR-2021 09:30(after 21 hours) experienced fever and on an unknown date muscle pain, headaches, swollen glands, the arm where the vaccine was injected could not be lifted and still have difficulty lifting it, stiff neck, pain it causes in her back, legs, neck, lack of strength making it difficult for me to sleep, lack of strength making it difficult for me to sleep, the levels her doctor seen for the C-Reactive protein QT test have doubled. The patient visited doctor and told him that since she received the vaccine her body was not the same and the pain do not stop. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included C-Reactive protein QT test have doubled on 12Apr2021 was 7500 and on 26Apr2021 was 8510. Therapeutic measures were taken for the events with Medrol-Valium-Mobic. The outcome of the event fever was not recovered and rest of the events was unknown. Follow-up attempts are possible. Further information is expected.
56 2021-06-01 swollen extremities This is a spontaneous report from a contactable consumer, the patient. A 56-year-old female patient ... Read more
This is a spontaneous report from a contactable consumer, the patient. A 56-year-old female patient received first dose of BNT162B2 (COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on Monday 24May2021 (age at vaccination: 56 years) at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 24May2021 night, the patient started feeling tingling in her left foot. Patient stated that tingling went away for a little bit but came back worse. The patient felt like the toes were on fire. On an unspecified date in May2020, the patient stated that she also has edema in her left leg. Patient was asking whether this was a normal reaction after the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
56 2021-06-01 swelling, lymph node swelling This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female pat... Read more
This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received the first dose of BNT162B2(COVID-19 VACCINE, formulation: solution for injection, (Batch/Lot number was not reported) via an unspecified route of administration on 14May2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 14May2021 the patient experienced barely walk (gait disturbance). In May2021, for a good 8-9 days under armpit and breast side of vaccine, swollen (swelling), still feeling pain and tenderness (pain), still feeling pain and tenderness (tenderness), pain under my arm pit (axillary pain), still tired (fatigue), lymph node swollen (lymphadenopathy). The patient was still tired and feel like it's not her, still pain under my arm pit, breast is not swollen, it's a little tender, not like it was last week. Still tired, pain under armpit, not going away, it's tolerable but not comfortable. After this experience, the patient was hesitant to get the second dose. Her appointment was scheduled on 04June2021. The doctor said to wait an extra week. The clinical outcome for I could barely walk was unknown, and the clinical outcome for the events swelling, still feeling pain and tenderness, still pain under my arm pit, still tired, lymph node swollen was not recovered. Information on lot/batch number has been requested.
56 2021-06-01 swelling Swelling in the arm pit of her left arm /swelling feels like a sore water pouch; Swelling in the arm... Read more
Swelling in the arm pit of her left arm /swelling feels like a sore water pouch; Swelling in the arm pit of my left arm with small circular bruising; I have swelling in the arm pit of my left arm with small circular bruising. It hurts and aches/swelling felt like a sore water pouch; The ache was also felt through my whole arm; This is a spontaneous report from a contactable consumer (patient) via a sponsored program. This non-pregnant 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 30Apr2021 at 13:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications were not reported. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. On 30Apr2021 at 16:30 the patient experienced swelling in the arm pit of her left arm with small circular bruising. She reported it hurt and ached and she had to take ibuprofen to sleep. The ache also was felt through her whole arm. The swelling felt like a sore water pouch. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of swelling in the armpit of her left arm with small circular bruising, it hurt and ached, swelling felt like a sore water pouch, and ache was felt through her whole arm were reported as recovered in 2021. It was also reported that since vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed; information about lot number cannot be obtained.
56 2021-06-02 pancreatitis 30 minutes after receiving the shot I became dizzy, head hurt, burning eyes, fatigue and nauseous. T... Read more
30 minutes after receiving the shot I became dizzy, head hurt, burning eyes, fatigue and nauseous. The second day to present day, all the symptoms from first day plus a stomachache. Over the course of the next week, all symptoms continued then chest pains and a high resting pulse began. Eight days after the shot I went to the emergency room for chest pains and all the symptoms from above. I followed up with primary care three days after ER visit and was told of a possible pancreatitis. My gastroenterologist does not have time in his schedule to see me anytime soon. I?m in the process of trying to get an appointment with a gastroenterologist. If symptoms worsen I will go back to emergency room. I?m waiting to be accepted by a office for treatment.
56 2021-06-02 swelling face Rash on right cheek, itchy, raised, deep red, uncomfortable followed in a few days by nerve pain. Af... Read more
Rash on right cheek, itchy, raised, deep red, uncomfortable followed in a few days by nerve pain. After taking a steroid and anti- viral drug for 1 week, the inflammation decreased and it was no longer uncomfortable. The nerve pain is now gone as of 6/3, and my rash is much small and no longer itches.
56 2021-06-05 swelling face, lymph node swelling 1. Swollen lymph nodes--axillary, left upper chest, arm. Also left side of face--cheek, jaw, throa... Read more
1. Swollen lymph nodes--axillary, left upper chest, arm. Also left side of face--cheek, jaw, throat (tonsil). This began within half and hour of vaccination and lasted about 3-4 days. Also happened similarly on second dose (4-16-21, same location). 2. Left upper arm pain. Still ongoing at this time (June 6, 21). Mild to moderate. Occasionally up into neck to behind ear. Difficult to lift left arm from straight out (away from body) further up. Was not affected by second dose.
56 2021-06-06 c-reactive protein increased The next morning after I woke up with real bad nausea, diarreah, headache, shakes and chills but nev... Read more
The next morning after I woke up with real bad nausea, diarreah, headache, shakes and chills but never developed a fever. And to date I am still experience random symptoms listed associated. I developed pain down both arms, down my neck and chest area also. I have fallen 2 different times but is unsure of why I am now falling
56 2021-06-07 guillain-barre syndrome It started with feeling run down, are started hurting, started running fever, so then it proceeded t... Read more
It started with feeling run down, are started hurting, started running fever, so then it proceeded to feel nothing on my left side, feeling like with no strength at all. My left side start going down with no feeling. It stated with CIDP. GBS. Then I was admitted into the hospital on Sunday 03/28/2021. I was there for four days. Discharged on 03/31/2021.
56 2021-06-07 peripheral swelling Right upper chest pain at end of inspiration and when lying flat - 5/10/2021-5/10/2021. Left calf pa... Read more
Right upper chest pain at end of inspiration and when lying flat - 5/10/2021-5/10/2021. Left calf pain and swelling 5/15/2021 to present. DVT diagnosed 6/1/2021.
56 2021-06-11 swelling next day, got welling of neck, fever, trouble breathing
56 2021-06-12 swelling Almost immediate (next day) started having numbness in left fingers 3-5, heavy, glove like feeling i... Read more
Almost immediate (next day) started having numbness in left fingers 3-5, heavy, glove like feeling in left hand, pain down left arm gradually intensifying in frequency and severity over 6-7 weeks. Cervical MRI ordered due to intense, sharp, stabbing left arm pain and numbness down ulnar side of left arm. Admitted to Medical Center on June 11, 2021 due to findings on MRI and worsening of symptoms. Drs. have narrowed down the DX to likely Acute Transverse Myelitis- pending results from a spinal tap done June 12, 2021. Currently still admitted for pain control and IV steroids to control swelling on spinal cord.
56 2021-06-13 swelling face Pt received the first dose on 04/30/2021, with no side affects. She received the second dose, 05/21... Read more
Pt received the first dose on 04/30/2021, with no side affects. She received the second dose, 05/21/21 and tolerated it well that day, the following day she had mild chills and shakes. Two days after receiving the vaccine she started having episodes of syncope. When she felt this coming on she would lay down in bed. Had a few episodes where she was nauseas and would vomit. At approximately 2:00pm she blew her nose and when she did she felt a pop under her right eye. Immediately there was swelling under eye, pockets of blood where bruising started. She was taken to Medical Center. After being seen it was determined that she had a Orbital Floor Blowout in her right eye socket. She was questioned as to trauma to the eye, abuse, etc. There was none - she had not fallen or hit anything either. There was no other evidence of an external injury that caused this. No history of injury to this eye or facial trauma at all. She had to see a plastic surgeon the following day and an ophthalmologist. She had to have surgery to place a titanium mesh plate under her eye. Follow Up Appointments are still happening.
56 2021-06-14 lymph node swelling A few after the vaccine dose 2 you couldn't see well prescription glasses, both eye were blurry, tha... Read more
A few after the vaccine dose 2 you couldn't see well prescription glasses, both eye were blurry, that latest for 2 weeks. Swelling under the left arm that latest for 2/3 days
56 2021-06-15 lymph node swelling a breast ultrasound revealed swollen lymph nodes on left side under armpit; This is a spontaneous re... Read more
a breast ultrasound revealed swollen lymph nodes on left side under armpit; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EK9231), via an unspecified route of administration in arm left on 01Jan2021 at 11:00 as a 1st dose, single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. Age at vaccination was 56 years. The patient's concomitant medications included raloxifene hydrochloride (RALOXIFENE [RALOXIFENE HYDROCHLORIDE]), vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]), krill oil, levocetirizine dihydrochloride (XYZAL) and Multivit. It was reported that, no other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 20Jan2021 at 11:00 AM, the patient experienced a breast ultrasound revealed swollen lymph nodes on left side under armpit. Treatment was not received for the event. On 20Jan2021, the patient underwent lab tests and procedures which included breast ultrasound, resulted as swollen lymph nodes on left side under armpit. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL8982), via an unspecified route of administration in arm left on 01Feb2021 as a 2nd dose, single dose for COVID-19 immunization. The outcome of the event was unknown. Follow-up attempts completed. No further information expected.
56 2021-06-15 swelling face So the day I go the shot, I got a fever of about 101, I took Tylenol so it didn't last super long. I... Read more
So the day I go the shot, I got a fever of about 101, I took Tylenol so it didn't last super long. I went home and went to bed and probably slept about 14 hours. The next day I had a fever again and got extremely nauseas, I was also very very tired. I had nausea for about a week and the fever subsided after about a day. When that finally went away, three weeks later I started to get a severe pain in my right buttocks area that was excruciating. I took medicine thinking it would go away and then I started getting a rash and the pain was all underneath that rash. I went to the DR and he said it was 100% shingles but fit the description so he treated me for that and it lasted about two weeks more. He gave me gabapentin to help with the pain. It was considered a mild outbreak of shingles. A couple weeks later my face swelled up on the left side. I went to my dentist and found out that my body was rejecting one of my teeth, I had to be treated for an infection in my mouth and then do a temporary bridge.
56 2021-06-16 lymph node swelling, peripheral swelling Within five minutes of receiving the vaccination part states that she did not feel face got hot and... Read more
Within five minutes of receiving the vaccination part states that she did not feel face got hot and jaw got hot and hurting, was hlight headed heart, blood pressure went up and heart palpitation, tough swelling and slightly fainted and she waited 45 minutes an tough went down jaw was hearting finger and feet swell and chest was hurting like someone was sitting on her chest, stomach cramps and heart rate was at 100. Called the Dr. told to take Benadryl and Tylenol for pain. Told to take Benadryl and Tylenol before the second dose and was told to have a driver to take her. The second vaccination the jaw was hurting and chest was heavy and glad swelling and left side swelling on the leg and vision was blurry and lodes was swollen and a fainting spell that day. Still have pressure in chest and extremely fatigue and vision is on and off blurry and nausea and diareeha.
56 2021-06-16 peripheral swelling I had swelling under right armpit, swelling of the feet, no taste,no appetite, could not get enough ... Read more
I had swelling under right armpit, swelling of the feet, no taste,no appetite, could not get enough sleep, weird smells, and redness around the shot and armpit.
56 2021-06-16 swelling face Numbness of lower face; swelling of lower face and tongue; swelling of lower face and tongue; sensat... Read more
Numbness of lower face; swelling of lower face and tongue; swelling of lower face and tongue; sensation of lump in throat (throat closing); extreme thirst; low grade fever; This is a spontaneous report from a non-contactable consumer. This 56-year-old female consumer received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN5318) via an unspecified route of administration of single dose (at the age of 54-year-old) on 14Feb2021 at 04:00 PM on right arm for COVID-19 immunization. Patient's allergies included allergies of Soy, corn and honey. The patient's medical history and concomitant medications were not reported. On 14Feb2021, at 04:30 PM patient experienced numbness of lower face, swelling of lower face and tongue, sensation of lump in throat (throat closing), extreme thirst and low grade fever. It was reported that patient required emergency room and patient was monitored for vitals 4.5 hr; and treatment of anti inflammatory and antihistaminic was given. It was reported that patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
56 2021-06-16 swelling The 2nd shot very bad migraine; chills; sore arm; swollen armpit; swollen breast all right side, ver... Read more
The 2nd shot very bad migraine; chills; sore arm; swollen armpit; swollen breast all right side, very painful; swollen breast all right side, very painful; couldn't sleep; constance ache and shooting pain to my nipple on this right side; back swollen; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0170), dose 2 via an unspecified route of administration, administered in Arm Right on 27Apr2021 14:00 (at the age of 56-year) as 2nd dose, 0.3 ml single dose for COVID-19 immunization. Medical history was none provided (Patient history: No). Concomitant medication(s) included LISINOPRIL, OMEPRAZOLE; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and LORATADINE taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). The patient previously received first dose of BNT162B2 (Batch/Lot Number: EW0158) via an unspecified route of administration, administered in Arm left on Apr2021 02:00 PM (at the age of 56-year), 0.3 ml for COVID-19 immunization and experienced migraine, sore arm on the left side the 1st shot. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient stated, both shots very bad migraine a mile sore arm on the left side the 1st shot. The 2nd shot very bad migraine chills and sore arm (29Apr2021 at 12:00) Wednesday the day after. Thursday morning 2nd shot swollen armpit, swollen breast all right side, very painful all day Thursdays all night thursday couldn't sleep (29Apr2021 12:00). Friday the swelling had my right side to the center of my back swollen (2021). Call my doctor went in that friday afternoon she stated it was a reaction to the shot my lymph Nodes. that Saturday and Sunday I couldn't put my bra on due to the swelling. The medication I was giving help some with the swelling and pain. On Monday the next the swelling is not the same but as of today I am still swollen and have a different pain it's more of a constance ache and shooting pain to my nipple on this right side (2021). armpit and breast very swollen. Treatment (Medication) was used for adverse events. Patient visited Doctor or other healthcare professional office/clinic for events. Therapeutic measures were taken as a result of the 2nd shot very bad migraine, chills, sore arm, swollen armpit, swollen breast all right side, very painful , couldn't sleep, constance ache and shooting pain to my nipple on this right side, back swollen. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.
56 2021-06-16 swelling dizziness; heart was racing/rapid heart beat; throat was closing; felt like her throat/neck was swel... Read more
dizziness; heart was racing/rapid heart beat; throat was closing; felt like her throat/neck was swelling; felt like her throat/neck was swelling; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (BNT162B2- PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, with a needle, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 14Mar2021 at 11:30 (at the age of 56 year-old) as First dose, SINGLE DOSE for covid-19 immunisation. Patient took Covid-19 vaccine to protect against covid-19. Medical history included ongoing Blood pressure diagnosed probably 7 years ago and Abdominal aortic aneurysm burst from an unknown date and unknown if ongoing. AE(s) following prior vaccinations reported as none. Family Medical History Relevant to AE reported as none. No relevant test was performed. Concomitant medications included losartan and metoprolol been on it for years, taken for blood pressure from an unspecified start date and ongoing. Patient was not received any additional vaccine on same date of COVID-19 vaccination. Patient was not received any other vaccine prior four weeks of vaccination. On 14Mar2021 the patient experienced dizziness, heart was racing/rapid heartbeat, throat was closing and felt like her throat/neck was swelling. She reported that immediately after received her first dose of the Pfizer-Biontech Covid19 vaccine, yesterday, she had dizziness, her heart was racing, and she felt like her throat was closing. She was treated on site with benadryl and was able to leave 30 minutes later. She may not be able to get the second dose due to severe reaction after the first dose. She received her first dose yesterday, 14Mar2021, and she had an immediate reaction like within a minute or minute and a half of receiving the vaccine. She felt dizziness, rapid heartbeat, and felt like her throat/neck was swelling. She clarifies she doesn't know if it was swelling, it may have been psychological. She could have just gotten herself worked up once she was in that situation all happened immediately after the vaccine at 11:30 AM. She clarifies further she doesn't think they saw swelling in her throat because they didn't give her an epi-pen, she was given Benadryl. She reported that the symptoms stopped within a half hour after the Benadryl. The patient underwent lab tests and procedures which included heart rate: rapid on unspecified date. Patient was not visited to emergency room and Physician Office for the events. Therapeutic measures were taken as a result of the events with benadryl. The outcome of the events was reported as recovered on 14Mar2021. No follow-up attempts are possible; Information about lot/batch number cannot been obtained.
56 2021-06-17 lymph node swelling, lymph node pain Mild body aches; Headache; Swollen lymph node in right armpit the size of 1/2 orange and some pressu... Read more
Mild body aches; Headache; Swollen lymph node in right armpit the size of 1/2 orange and some pressure and mild pain.; Swollen lymph node in right armpit the size of 1/2 orange and some pressure and mild pain.; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number EW0161 and expiration date: 31JUL2021) via intramuscular, on right arm, on 11Jun2021 at 17:00, (at the age of 56-year-old), as 2ND DOSE, SINGLE DOSE for covid-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. The patient is not pregnant at the time of vaccination. The patient had no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number:EW0151 and expiration date: not reported) via intramuscular, on Left arm, on 21May2021 at 17:35,(at the age of 56-year-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine.The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. After the vaccination patient has not been tested for COVID-19. It was reported that on 12Jun2021, the patient spent the afternoon at a hot (90 degrees) and sunny festival. The patient came home and watched TV for several more hours of no symptoms. The patient noticed the swollen lymph node described as swollen lymph node in right armpit the size of 1/2 orange and some pressure and mild pain as the patient went to bed on 12Jun2021 at 19:00. On 13Jun2021, the next day, it was more painful and increased in pain, the 3rd day the patient finally took an ibuprofen. On 15Jun2021 at 17:15, it seemed to lessen in pain without drugs but the patient will probably take another dose to sleep. On 13Jun2021, the patient experienced mild body aches and headache. The patient underwent lab tests and procedures which included body temperature: 97.8 on 11Jun2021 and 98.8 on 12Jun2021. Therapeutic measures taken in response to the event headache included administration of Excedrin, 1 pill by mouth on 13Jun2021 and ibuprofen by mouth on 15Jun2021 and ongoing lymph node in right armpit the size of 1/2 orange and some pressure and mild pain. It was reported that the ibuprofen helped. No treatment was given for the event mild body aches. Outcome of the event Swollen lymph node in right armpit the size of 1/2 orange, and some pressure and mild pain was recovering and the events mild body aches and headache recovered in Jun2021.
56 2021-06-19 lymph node swelling Fever, bodyaches and Swollen lymph node in neck region
56 2021-06-20 c-reactive protein increased Severe joint pain in neck, shoulders, elbows, wrists, hands, fingers, knees, ankles, feet, toes. Mo... Read more
Severe joint pain in neck, shoulders, elbows, wrists, hands, fingers, knees, ankles, feet, toes. Moves around day to day to different joints. Window from 10-11 am until 5-6 pm not as severe, Unable to function some days due to pain and swelling.
56 2021-06-21 peripheral swelling gained 5 pounds after each dose; really bad edema; foot's all swelled up; enlarged heart; rapid hear... Read more
gained 5 pounds after each dose; really bad edema; foot's all swelled up; enlarged heart; rapid heart beating; feels like she's going to die; soreness of the arm; throwing up; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, in Arm Left on 06Apr2021 (Batch/Lot Number: ER8735) (age at vaccination 56 year) as single dose for covid-19 immunisation. Medical history included ongoing blood cholesterol increased for over 25 years , stress, anxiety, post-traumatic stress disorder. Concomitant medication(s) included atorvastatin (LIPITOR) for blood cholesterol increased. The first dose of vaccine was administered on 16Mar2021 (lot EP753T) in arm left and patient reported weight gain (5 pounds). After having the second dose of vaccine, on 03May2021, patient experienced enlarged heart, and rapid heart beatings. Patient reported she had to go twice to the hospital, had to call 911, had to get a doppler on her chest, she's been to the cardiologist 5 times just in the last month. Caller states she has to go for a cardiogram on the 16th and may have to have open heart surgery. Patient reported that since having the Covid shot, she's had nothing but trouble. She's not just having soreness of the arm and throwing up. Patient reported that next day, she gained 5 pounds, she retained water or something, she has really bad edema, her foot's all swelled up now. Patient underwent EKGs, Chest X-rays, where it says she has an enlarged heart, rapid heart beating, she had a doppler heart monitor for 3 days. Caller states she has to get a cardiogram, an MRI. Caller states she has heart rhythm problems she feels it in her body. Caller states the doctors didn't say she had heart rhythm problems, but she feels fluttering in her heart. Outcome of events was unknown.
56 2021-06-22 peripheral swelling, lymph node swelling Fever, body ache, headache, back ache, joint pain, chills, shakes, painful lump under arm pit, lump ... Read more
Fever, body ache, headache, back ache, joint pain, chills, shakes, painful lump under arm pit, lump at injection sight, swollen arm, red rash, generalized itching around arm, itching over entire body, red spots spreaded
56 2021-06-23 swelling After the second COVID vaccine on 4/11, pt has become allergic to almost all foods, with reactions d... Read more
After the second COVID vaccine on 4/11, pt has become allergic to almost all foods, with reactions described as dizziness, swelling, throat swelling, a rash, and abdominal bloating
56 2021-06-24 guillain-barre syndrome Pt started with headaches sinus pain. Was treated at her family doctor for a sinus infection. These ... Read more
Pt started with headaches sinus pain. Was treated at her family doctor for a sinus infection. These symptoms did not go away and on 5/7/2021 she started getting tingling and numbness in her hands and feet. On 5/8/2021 she was taken to the Hospital and blood work and MRI was taken but did not see anything. She was told to follow up with her family physician on Monday 5/10/2021. She got worse in the evening and had trouble walking. She was taken to another hospital at 4:00 A M on 5/9/2021. On 5/9/2021 the neurologist thought she may have a chemical imbalance. After getting and MRI, blood work and and EMG on 5/10/2021 she was diagnosed with Gillian Barre syndrome and treatments
56 2021-06-24 lymph node pain Moderate fever; chills; spasms at injection site; severe muscle pain; lymph node pain; sore throat;... Read more
Moderate fever; chills; spasms at injection site; severe muscle pain; lymph node pain; sore throat; fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in her left arm on 17-MAR-2021 at 10:45 AM (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patient medical history included Type 2 diabetes, hypertension, high cholesterol, sleep apnoea, obesity. The patient past drug history was not reported. Concomitant medications included Amlodipine (MANUFACTURER UNKNOWN), Losartan (MANUFACTURER UNKNOWN) and Janumet (MANUFACTURER UNKNOWN) Lantus (MANUFACTURER UNKNOWN) Crestor (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 17Mar2021 6.00 PM the patient experienced moderate fever, chills, spasms at injection site, severe muscle pain, lymph node pain sore throat, and fatigue. The patient did not receive treatment for the reported events. The clinical outcome for Moderate fever, chills, spasms at injection site, severe muscle pain, lymph node pain, sore throat, and fatigue. was not recovered at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
56 2021-06-29 guillain-barre syndrome I60.9 - Nontraumatic subarachnoid hemorrhage, unspecified I62.00 - Nontraumatic subdural hemorrhage,... Read more
I60.9 - Nontraumatic subarachnoid hemorrhage, unspecified I62.00 - Nontraumatic subdural hemorrhage, unspecified G61.0 - Guillain-Barre syndrome G61.0 - Acute inflammatory demyelinating polyneuropathy
56 2021-06-29 lymph node swelling skin rash/rash; swollen lymph nodes/swollen lymph nodes on my right neck; has a bruise on the back o... Read more
skin rash/rash; swollen lymph nodes/swollen lymph nodes on my right neck; has a bruise on the back of her neck or like her muscle got hurt; has a bruise on the back of her neck or like her muscle got hurt; asthma/allergic asthma; ear hurts; Shingles; This is a spontaneous report from a contactable consumer(patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 08:00 (at the age of 56-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included Allergic asthma from an unknown and was ongoing. The patient concomitant medications were not reported. The patient with a history of allergic asthma who received the first dose of the COVID19 vaccine on (Monday) on 22Mar2021 at 8 AM. About 8 hours later around 3 PM (Monday) on 22Mar2021 she started to start felling some asthma /Asthmatic, like dealing with bad allergies because she has allergic asthma. It just got like she had dealing bad allergies. Not bad, but similar to when she is exposed to a lot of dust. She took her spray as she periodically took it. On (Wednesday) on 24Mar2021 (36 hours after), she noticed a skin rash and swollen lymph nodes on the right side of her neck, which was the opposite side of where she got her shot, she got shot on the left side on her arm. It feels like she has a bruise on the back of her neck or like her muscle got hurt. Sometimes her ear hurts too. She got the vaccination on her left side. She doesn't know if this was fairly typical or not. She was uncertain if she should get the second dose because she heard second shot is worse. The patient received the treatment spray for asthma. She has rash and swollen lymph still and she was wondering is it safe for me to take second dose giving that she has have this symptom. She saw Doctor on Friday (26Mar2021) and she told her that she got shingles, the rash, it turned out to be Shingles. She asked has a lot of people reported shingles. Her second dose scheduled for 12Apr2021. The outcome of skin rash/rash and swollen lymph nodes/swollen lymph nodes on my right neck was not resolved. The outcome of asthma/allergic asthma has a bruise on the back of her neck or like her muscle got hurt, ear hurts, shingles was unknown. No follow-up attempts are possible. No further information is expected.
56 2021-06-29 swelling face High heart rate for most of the day; Body aches; Running nose; sneezing; eye infection; rash on face... Read more
High heart rate for most of the day; Body aches; Running nose; sneezing; eye infection; rash on face and swollen; rash on face and swollen; This is a spontaneous report from a contactable Consumer (patient). A 56-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 13:00 (at the age of 56-years-old) as a dose 1, single for COVID-19 immunisation. Patient's medical history included seasonal allergy, mycotic allergy (mold), drug hypersensitivity to Penicillin and food allergy to wheat, all were from an unknown date and unknown if ongoing. Concomitant medications received within 2 weeks were not specified. Patient received Allergy shot (Other vaccine) on Left arm within 4 weeks on 01Mar2021. Patient did not have covid prior vaccination. On 03Mar2021 at 13:00, the patient experienced High heart rate for most of the day. Body aches, running nose, sneezing and then had an eye infection, rash on face and swollen that lasted for several days. On 09Mar2021 doing better but not fully recovered. Patient did not have any treatment for the events. He had been tested for covid post vaccination. The patient underwent lab tests and procedures which included heart rate: high, on 03Mar2021 and sars-cov-2 test (Nasal Swab) with unknown result, on 01Mar2021. The outcome of all the events were recovering. No follow-up attempts are possible. No further information is expected.
56 2021-07-02 lymph node swelling Vomiting for two days after shot and ondansetron prescribed; swollen glands on left side neck and cl... Read more
Vomiting for two days after shot and ondansetron prescribed; swollen glands on left side neck and clavical area; numbness in hands and fingers; raised blood pressure; 103F fever on day after shot; This is a spontaneous report from a contactable consumer (patient) reported for herself that, A 56-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 03:45 (at the age of 56-years-old) as dose 2, single for covid-19 immunization. Medical history included known allergies to Latex. There were no concomitant medications. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive Other medications in two weeks of vaccinations. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. Patient took first dose of bnt162b2 (Batch/Lot Number: EM9809), in Arm left, on 08Feb2021 03:45 for covid-19 immunization. On 02Mar2021, the patient experienced vomiting for two days after shot and ondansetron prescribed, swollen glands on left side neck and clavical area, numbness in hands and fingers, raised blood pressure and 103f fever on day after shot. The events resulted to physician office visit. (serious: no, as reported). The patient underwent lab tests and procedures which included blood pressure measurement: raised and body temperature: 103 fahrenheit on 02Mar2021. Treatment was received for the adverse events as ondansetron. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
56 2021-07-02 swelling face rash on cheeks, jawline and neck; facial swelling; itch skin around jawline, some welting.; This is ... Read more
rash on cheeks, jawline and neck; facial swelling; itch skin around jawline, some welting.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8731), via an unspecified route of administration in left arm on 21Apr2021 at 14:45 (at the age of 56 years old) as single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734), via an unspecified route of administration in left arm on 29Mar2021 at 05:45 PM (at the age of 56 years old) for covid-19 immunisation. The patient's medical history was not reported. The patient had known allergies to sulfa based meds, chlorine, latex, wasp sting, seasonal environmental allergy (spring). Concomitant medications received within 2 weeks of vaccination included gummy multi-vitamin, fish oil, calcium, magnesium. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. No symptoms for 1st dose. 2nd dose received around 2:45 pm and on 21Apr2021, around 8:45 pm patient experienced itch skin around jawline, some welting. Woke up following day with rash on cheeks, jawline and neck, took 2 Benedryl before bedtime, following day some facial swelling rash lower back. Emailed Dr. instructed to take Zyrtec day, and Pepcid then Benedryl at night. Followed instructions, following morning woke up to even more facial swelling once oval face was square. Went to walk-in clinic for steroid shot. The event resulted in: Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event: injection of dexamethasone and dexamethasone. Reporter considered events as non-serious. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
56 2021-07-05 lymph node swelling Fatigue started in the afternoon and took about 2 weeks to feel I no longer needed a daily nap. Lymp... Read more
Fatigue started in the afternoon and took about 2 weeks to feel I no longer needed a daily nap. Lymph nodes swelled up in both underarms and took about 1 week to resolve. Extreme body aches started Tuesday and lasted 24 hours. Slight chest pain and feeling like I couldn't catch my breath for about a week. Slight headache but nothing like when I had COVID-19. It felt very similar to when I had COVID-19 and triggered my body to react. This is why I have chosen not to do a 2nd dose.
56 2021-07-05 peripheral swelling I'm 56 and very healthy, never sick, never take meds and see a doctor for well-woman only. 3-4 week... Read more
I'm 56 and very healthy, never sick, never take meds and see a doctor for well-woman only. 3-4 weeks after the 2nd dose I started feeling my hands and feet were swollen and very painful to bend. It really hit me on March 28, 2021 I couldn't grab my sheets/blankets when I was cold and My feet hurt so badly I could barely walk. Also, I was very tired, dry eyes, dry mouth, A friend of mine said it sounded like rheumatoid arthritis. I researched it and went to doctor on March 29. She knows I've been healthy and laughed at my self-diagnosis. I have no family history of RA. I told my doctor I thought I got this because of the vaccine. My doctor ordered x-rays and blood work. On March 31st she called me and said my RF and CCP were off the charts, that I have RA and that I need to see a rheumatologist.
56 2021-07-08 lymph node swelling Fever; Body aches; headache; injection site pain and swelling; injection site pain and swelling; Swo... Read more
Fever; Body aches; headache; injection site pain and swelling; injection site pain and swelling; Swollen lymph nodes just felt crappy.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 24Mar2021 at 11:15 (at the age of 56-years old) as a single dose for COVID-19 immunisation. Medical history included diabetics. The patient had a history of allergy to antibiotics. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. On 24Mar2021 at 23:00, the patient had experienced fever, body aches, headache, injection site pain and swelling and swollen lymph nodes just felt crappy. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, body aches, headache, injection site pain and swelling and swollen lymph nodes just felt crappy was resolved on an unknown date in Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.
56 2021-07-11 lymph node swelling, lymph node inflammation, peripheral swelling 5 days after first injection lymph node in left arm became swollen. days later tenderness and swell... Read more
5 days after first injection lymph node in left arm became swollen. days later tenderness and swelling started traveling down my arm. day after second injection. lymph node became larger, entire arm more painful and swollen, and vein's all the way down to wrist was swollen, painful, and felt like a rubber band being stretched. could not lift up my arm. first was diagnosed with Lymphadenitis and was prescribed amoxicillin. days after kept getting worse so put on Bactrim for 2 weeks and was sent for an MRI of my arm for possible blood clot in arm. No clot detected . Today arm better, still have a small lump under arm and still feed some tightness/pulling/burning in my left arm.
56 2021-07-11 lymph node swelling After first dose: swelling of lymph nodes behind left knee; arm soreness; slight headache; slight f... Read more
After first dose: swelling of lymph nodes behind left knee; arm soreness; slight headache; slight fatigue After Second dose: arm soreness; slight headache; sore throat; overall body aches; fatigue; fever; dry eyes; muscle weakness; rash and itching at injection site
56 2021-07-11 peripheral swelling Morning after second dose, experienced severe pain running up the left side of neck, top of head and... Read more
Morning after second dose, experienced severe pain running up the left side of neck, top of head and right side of neck - severe ear aches, both ears - Still happening Following Monday (today) my left arm is swollen, red and radiating heat
56 2021-07-12 lymph node swelling High fever; Chills; Body aches; Headache; Loss of taste; Diarrhea; Swollen lymph nodes in arm pit an... Read more
High fever; Chills; Body aches; Headache; Loss of taste; Diarrhea; Swollen lymph nodes in arm pit and up left side of neck; Earache; Congestion; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left at age of 56 years (not pregnant) on 17Jun2021 14:00 (Lot Number: EP7533) as single dose for covid-19 immunisation. The patient medical history included Hoshimoto's thyroiditis, hypothyroid, Sjogren's Syndrome, mixed connective tissue disease, mitral valve prolapse, fibromyalgia, carotid artery disease. Concomitant medications included unspecified drugs the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose1 at left arm at age of 56 years on 20May2021 14:00 (Lot number EW0162) for COVID-19 immunization. On 18Jun2021 03:30am, The patient experienced high fever, chills, body aches, headache, loss of taste, diarrhea, swollen lymph nodes in arm pit and up left side of neck, earache, congestion, loss of appetite. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. No treatment received. The outcome of the event was recovering. Lot/batch number is available; Additional information has been requested.
56 2021-07-12 lymph node swelling Considerable swelling in the lymphnodes; Quite painful in left armpit; This is a spontaneous report ... Read more
Considerable swelling in the lymphnodes; Quite painful in left armpit; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old-non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 25Mar2021 at 09:00 (at the age of 56-year-old), as a single dose for COVID-19 immunisation. Medical history includes COVID-19. The patient did not have allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced considerable swelling in the lymph nodes and quite painful in left armpit. The patient did not receive any treatment for the events. The clinical outcome of the events considerable swelling in the lymph nodes and quite painful in left armpit was resolving at the time of this report. No follow-up attempts are needed. Information about lot/ batch number cannot be obtained.
56 2021-07-12 peripheral swelling, swelling face, swelling Had shot on thursday at 6pm had a very sore arm and back all day friday. saturday about 8 am my wri... Read more
Had shot on thursday at 6pm had a very sore arm and back all day friday. saturday about 8 am my wrist started to itch n so did the inside of my elbows. i went to the bathroom n i was completly covered in hives i was beet red n my neck face eyes hands were completly swollen and i threw up. i took two benadryl and it helped alot took three more throughout the day n i was fine. sunday am about 8 again same thing only much more intense itching oh and my heart was beating very rapidly both days took benedryl again and it helped but then went to urgent care because my face was still swollen n wouldnt go down n since it happened twice i was not going to go through that again. ch
56 2021-07-14 swelling Patient was concerned she might have an adverse reaction to the covid 19 vaccine due to her long lis... Read more
Patient was concerned she might have an adverse reaction to the covid 19 vaccine due to her long list of allergies, and patient stated that the doctor told her to only get the Pfizer vaccine. We administered the Pfizer vaccine and as patient was waiting, she started noticing that she felt a pressure in her head around 10 minutes into her waiting period. Then the patient said the pressure spread to her ears. She began to feel woozy. Finally when the pressure hit her neck area, she accepted some benadryl liquid. We administered 10ml of benadryl generic around 12:10 pm. We had offered the patient ice packs numerous times, but she declined. However, the patient did accept a snack and something to drink. Then around 12:25 pm, the patient stated that the swelling/pressure in her neck was a little worse, so we decided to administer another 10ml of liquid benadryl generic. After about another 15-20 minutes, the patient said the swelling in the throat was no longer getting worse, and that it was, in fact, getting better. The patient stayed in the pharmacy area for a little over an hour.
56 2021-07-17 fluid retention, swelling, swelling face throat felt tight; swelling over the body, really bad over the body and face, she noticed that I am ... Read more
throat felt tight; swelling over the body, really bad over the body and face, she noticed that I am still filled with fluid; She thought she had an allergic reaction to the new environment; She looks like an Alien from outer space and thought was it was the vaccine. She has not felt quite right. She felt a little off; swelling over the body, really bad over the body and face, she noticed that I am still filled with fluid; facial and eye swelling; facial and eye swelling; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: EN6208, Expiration Date: Unknown), via an intramuscular, administered in left arm in the muscle on 22Mar2021 at 17:15 (at the age of 56-year-old) as a single dose for covid-19 immunisation at Clinic. The patient had no medical history and did not administered any concomitant medications. No additional vaccines administered on same date of the Pfizer Suspect and no prior vaccinations received within 4 weeks. The patient family medical history was none. Relevant lab tests were not performed. After the first dose of Pfizer covid 19 vaccine on 22Mar2021, she flew out of town the next day, 24 hours later, and about 3 days into her trip away on 26Mar2021, she noticed her face (facial) and eyes became swollen, was reported as worsened. She is home now, and it did not go away. She thought she had an allergic reaction to the new environment. Her eyes are so swollen, and her throat felt tight (throat tightening) on 29Mar2021. It was unknown and it was progressively happening. She has taken Benadryl. She just thought it was a change in environment because she was in a desert environment and she lived in a humid environment. She looks like an Alien from outer space and thought was it was the vaccine. She has not felt quite right and felt a little off. No emergency room or physician office required for the events. She stated that she went to urgent care because they are not going away, was chalking it up to her traveling and being on the plane as she was in dry desert air and lived in humidity. She had been home several days, it was not going away with Benadryl or anything. It was 3 to 4 days later, she got treated at urgent care, because her reaction was swelling over the body, really bad over the body and face. They put her on prednisone for 5 days to reduce the swelling. Patient came today (as per report) from her OB, GYN, and she noticed that she was still filled with fluid. She is reluctant to tell her whether to get the second dose or not and enquired whether it is safe to get the second dose, which is due on monday. She did not require an epi pen and not a hypochondriac. This doctor also told her, that she believes you can get it up to 42 days later. She would like to know if there are any other people who are experiencing this side effects. The reporter assessed the events as non-serious. The outcome of the events facial and eye swelling, throat felt tight, swelling over the body, really bad over the body and face was not recovered and the rest of the events was unknown. No follow up attempts are possible. No further information is expected.
56 2021-07-17 lymph node swelling Rash on face that is still here 3 weeks later.; tiredness; Headache; nausea; swollen lymph nodes; mu... Read more
Rash on face that is still here 3 weeks later.; tiredness; Headache; nausea; swollen lymph nodes; muscle and joint pain; muscle and joint pain; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA vaccine, lot number: EL9263) via an unspecified route of administration in left arm on 06Mar2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient didn't take any concomitant medications. The patient was allergic to sulfa drugs. Prior to vaccination, the patient had not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Mar2021 at 16:00, the patient experienced rash on face, tiredness, headache, nausea, swollen lymph nodes, muscle pain and joint pain. It was reported patient had rash on face that was still there 3 weeks later. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of adverse event rash on face, which included treatment with cream. The clinical outcome of the event rash on face was not recovered, while of tiredness, headache, nausea, swollen lymph nodes, muscle pain and joint pain was recovered on unknown date at the time of this report. No follow-up attempts are needed. No further information is expected.
56 2021-07-17 lymph node swelling Large swollen lymph node to the left of my left breast.; This is a spontaneous report from a contact... Read more
Large swollen lymph node to the left of my left breast.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number EK8734) via unspecified route of administration in the left arm on 27Mar2021 at 10:00 (at the age 56-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity. The patient had no known allergies to medications, food and other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EN6200) via unspecified route of administration in the left arm on 06Mar2021 at 10:00 (at the age 56-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 29Mar2021 at 20:00, the patient experienced large swollen lymph node to the left of left breast, was not quite under the arm and lymph node was painful. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of painful lymphadenopathy was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
56 2021-07-17 lymph node swelling she had a pet scan and lymph node illuminated on right arm, not big but could see on pet scan.; Thi... Read more
she had a pet scan and lymph node illuminated on right arm, not big but could see on pet scan.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left at the age of 56-year-old on 01Apr2021 (Lot Number: ER8737) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Stage 4 melanoma that went to her bone from 2014, had a pituitary tumor removed in 2014 a month after they removed her ischium bone. The patient's concomitant medications were not reported. The patient previously took Yervoy from 2014 to an unknown date for immunoadsorption therapy, took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on arm right at the age of 56-year-old on 11Mar2021 (Lot number: EN6208) for covid-19 immunisation. Since her second vaccine, she had a pet scan and lymph node illuminated on right arm, not big but could see on pet scan. She had her first vaccine on 11Mar2021, and the second vaccine on 01Apr2021. She got them three weeks apart. She got one in her left arm and one in her right. She just recently had a PET scan. She has a history of cancer, stage 4 melanoma that went to her bone in 2014. Initially they said last week her cancer was okay. Then, they said they wanted her to come in. They don't want to alarm her but want her to get an Ultra Sound. They noticed her lymph node was illuminated on her right arm. It is not very big. She was told they are seeing this with the vaccine. They told her they are seeing this basically all over the countries, on pet scans from people that have had the covid vaccine. They haven't said it's cancer but just a reaction to the vaccine. She got the PET scan a week ago on the 22Jun2021 or the 23Jun2021. She can't feel it, so she doesn't know if it has changed. She doesn't remember which arm she got each one in, but she knows she did alternate arms. The patient underwent lab tests and procedures which included positron emission tomogram: lymph node illuminated on right arm, not big but could see on pet scan on an unknown date (reported as 22Jun2021 or the 23Jun202). The outcome of the event was unknown.
56 2021-07-17 lymph node swelling 48 hours after vaccination, developed swollen lymph nodes on right neck (front and back); Red rash s... Read more
48 hours after vaccination, developed swollen lymph nodes on right neck (front and back); Red rash spots on neck; 8 hours after, started to feel asthma; Felt like when exposed to a lot of dust and very allergic to dust mites; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: ER8730) via unspecified route of administration in left arm on 22Mar2021 at 08:00 as a single dose (at the age of 56-years-old) for COVID-19 immunisation. The patient had known allergies to sulfonamides and monosodium glutamate. The patients medical history included hypertension and asthma. The concomitant medications included valsartan (MANUFACTURER UNKNOWN) 180 mg used once daily for an unknown indication and multivitamin for women (MANUFACTURER UNKNOWN) for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 22Mar2021 at 15:00, 8 hours after the vaccine shot, the patient felt the asthma as she has allergic asthma and felt like when she was exposed to a lot of dust as she was very allergic to dust mites; On 24Mar2021 at 08:00, 48 hours after the shot, the patient experienced swollen lymph nodes on right neck (front and back) and red rash spots on the neck. No treatment was received for the events. The clinical outcome of the reported events was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
56 2021-07-17 peripheral swelling, lymph node swelling She had swelling in the lymph nodes of both armpits; She got her second COVID-19 Vaccine dose on 12A... Read more
She had swelling in the lymph nodes of both armpits; She got her second COVID-19 Vaccine dose on 12Apr2021, and had swelling in her arm; She got her second COVID-19 Vaccine dose on 12Apr2021, and had a little feeling of being tired for 2 days.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 56-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number and Expiration date was unknown) via an unspecified route of administration on 12Apr2021 (at the age of 56-year-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on unspecified date in 2021 as a single dose for COVID-19 immunization. Patient got her second COVID-19 Vaccine dose on 12Apr2021, and had no big things happened/did not experienced any big reaction, except swelling in her arm (arm swelling), and a little feeling of being tired for 2 days on an unspecified date in Apr2021. She said after those 2 days she had been feeling well. She said the day before yesterday (29Jun2021), she had swelling in the lymph nodes of both armpits. She said she was going to see her doctor (about the swollen lymph nodes) but wanted to doublecheck with Pfizer to see if having the swollen lymph nodes in both armpits so long after her second COVID-19 Vaccine dose was normal. She said she knew of other people who had swollen lymph nodes in their armpit the day after getting their COVID-19 Vaccine shot. She said the swelling in the lymph nodes of both armpits was strange for her, and she wanted to contact Pfizer to see what to do to prepare for her doctor's appointment. She took tylenol and she was feeling better. She did not feel it anymore on left arm, but still feels on right arm. She stated that her husband said that patients had been reporting this effect days after, but it was been weeks after the vaccine. The outcome of the event she had swelling in the lymph nodes of both armpits was not recovered and the rest of the events was recovered on an unspecified date in Apr2021. Follow-up attempts are needed. Further information is requested.
56 2021-07-18 lymph node swelling Swelling of lymph nodes around left side of body (specifically breast area)
56 2021-07-19 axillary mass Sick with low grade fever and fatigue for 5 days. Large lump under arm receiving the injection which... Read more
Sick with low grade fever and fatigue for 5 days. Large lump under arm receiving the injection which was sore to the touch for about 3 days.
56 2021-07-20 lymph node swelling, swelling Enlarged axillary lymph nodes, ( left), left side of neck swelling, fever ( 100.5). Patient evaluate... Read more
Enlarged axillary lymph nodes, ( left), left side of neck swelling, fever ( 100.5). Patient evaluated in ED on 07/18/2021, f/u at Health Center on 07/21/2021
56 2021-07-21 lymph node swelling, swelling Rash; Swollen supraclavicular lymph node; Swelling; red patch (approx. 2-1/2 inches); pain and itchi... Read more
Rash; Swollen supraclavicular lymph node; Swelling; red patch (approx. 2-1/2 inches); pain and itching in the area of the shot; pain and itching in the area of the shot; Chills; tiredness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0183), via an unspecified route of administration, administered in right arm on 22May2021 13:00 (at the age of 56 years old) as dose 2, single for COVID-19 immunization. Medical history included endometrial cancer from Jul2020 to 26Mar2021, radical hysterectomy from an unknown date, ongoing obesity, seasonal allergies from an unknown date, and latex allergy from an unknown date. Concomitant medications included fluticasone propionate (FLONASE); and famotidine; both taken for an unspecified indication. The patient was previously vaccinated with dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0172) on 01Mar2021 01:00 PM, right arm, for COVID-19 immunization. The patient experienced rash and swollen supraclavicular lymph node on 23May2021 10:00. She also reported swelling, red patch (approx. 2-1/2 inches), pain and itching in the area of the shot, chills, and tiredness on 23May2021 07:30. No treatment was received for the events. The patient was recovering from the events. Follow-up attempts are completed. No further information is expected.
56 2021-07-21 lymph node swelling Numbness in lower extremities; Mild body aches; Fever; A large swollen gland located near collar bon... Read more
Numbness in lower extremities; Mild body aches; Fever; A large swollen gland located near collar bone on the left side of body.; Severe headache; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6207) via an unspecified route of administration on 29Mar2021 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN 6203) via an intramuscular route of administration in the left arm on 08Mar2021 at 12:00 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 05:00, the patient experienced severe headache, fever, mild body aches occurred the day after second vaccination and experienced a large swollen gland located near collar bone on the left side of her body and numbness in lower extremities. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of severe headache, fever, mild body aches, large swollen gland and numbness in lower extremities were not recovered. No follow-up attempts are needed. No further information is expected.
56 2021-07-22 lymph node swelling 1 large inflamed lymph node; Swollen lymph nodes; This is a spontaneous report from a contactable co... Read more
1 large inflamed lymph node; Swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the left arm on 13Mar2021 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications included daily multivitamins (MANUFACTURER UNKNOWN) for unknown indication and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021, the patient reported of swollen lymph nodes; left clavicle (large) & armpit (armpit discovered by doctor). Swollen left clavicle node had then gone down. On 26Mar2021, the patient had swollen lymph nodes on right side back of neck. The patient had one large inflamed lymph node and smaller ones into hair line. They became pink/red, warm, protruding, reduced with ibuprofen but did not go away. It had become more enlarged and irritated in the evening and at night. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the Swollen lymph nodes and Inflammation, which included treatment with ibuprofen. The clinical outcome of the events swollen lymph nodes and inflammation were not resolved. No follow-up attempts are needed. No further information is expected.
56 2021-07-22 lymphatic obstruction This is a spontaneous report from a Pfizer-sponsored program Pfizer RxPathways via a contactable con... Read more
This is a spontaneous report from a Pfizer-sponsored program Pfizer RxPathways via a contactable consumer reported for herself. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) at the age of 56-year-old, as single dose for covid-19 immunization. Medical history included back surgeries, reported she had a history of back surgeries in the past all of which she recovered well from and mild osteoarthritis in the past. The patient's concomitant medications were not reported. The patient received the historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date for Covid-19 immunization. On an unspecified date in 2021, she seemed to be having an ongoing reaction to the vaccine resulting in edema, parasthesia and severe joint pain. She was concerned at this point and would like to know how long it can take for the inflammation in her body to subside. She was extremely healthy and fit and have never experienced anything like this. Caller was calling about the covid vaccine. She was having long term reactions. She had seen several doctors, internist, vascular doctor, neurologist, and orthopedist. Her symptoms were severe joint swelling and pain in her knees and thumbs, she had mild osteoarthritis, paresthesia, neuropathy and severe edema. She is an armature athlete. She was scared because her symptoms were not going away. She wanted to do more than reporting bad side effects she would like to speak to someone to see if there are any other people reporting this. Within a couple weeks began to experience the following symptoms: severe inflammation and joint pain, pain in knees and thumbs, mild osteoarthritis in the past that was now severely inflamed, paresthesia described as pins and needles, neuropathy in the hands and feet falling asleep, burning sensation, severe edema, and lymphedema in the legs. Caller reported she was still experiencing the pain right now and it felt like her knee and thumb joints are on fire. Caller had sought medical care from the orthopedic, vascular, and neurologist. They had checked for DVT and autoimmune diseases. Caller was seeking information if other patients have reported these long lasting symptoms. The outcome of the event severe edema, paresthesia described as pins and needles, severe joint pain was not recovered. The outcome of the other events was unknown. Information on the batch/lot number has been requested.
56 2021-07-22 swelling face slight bronchial swelling; Bleeding; bloody stools; pain/body aches unable to get out of bed; nausea... Read more
slight bronchial swelling; Bleeding; bloody stools; pain/body aches unable to get out of bed; nausea; tired; Projectile Vomiting burning; Stomach pain; Face swelling eyes; Face swelling eyes; esophagus pain burning; Immediately Tongue swelling; Chest pain; diarrhea burning; This is a spontaneous report from a contactable consumer (patient self). A 56-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 23Apr2021 14:00 (Batch/Lot number was not reported) (at the age of 56-year-old, not pregnant) as dose 1, single for COVID-19 immunisation. Medical history included ehlers danlos syndrome, ulcerative colitis, rheumatoid arthritis (ra), known allergies sulfa some local anesthetic. Concomitant medications included chlordiazepoxide (LIBRIUM); clonidine; fluticasone propionate, salmeterol xinafoate (ADVAIR); azelastine hydrochloride, fluticasone propionate (DYMISTA); cycloben. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was other. Since the vaccination, the had not patient been tested for COVID-19. On 23Apr2021 14:15, immediately tongue swelling/face swelling eyes, slight bronchial swelling, pain, nausea, tired, projectile vomiting burning, diarrhoea burning, stomach pain, esophagus pain burning, body aches unable to get out of bed, bleeding, bloody stools, chest pain. It was horrendous. The events resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage]. Therapeutic measures were treatment 28 days prednisone several medications. heart 'mon'. Outcome of the events was not resolved. Information on Lot/Batch information has been requested.
56 2021-07-23 swelling 8 hours after the vaccine sensation of tongue swelling (not visible). Tongue weird feeling since th... Read more
8 hours after the vaccine sensation of tongue swelling (not visible). Tongue weird feeling since then. Increase in frequency of baseline urticaria and angioedema.
56 2021-07-25 peripheral swelling Month later blood sugar went to hyperglycemia your prior dosage insulin was not working and blood in... Read more
Month later blood sugar went to hyperglycemia your prior dosage insulin was not working and blood increased to 300-500 range. Prior range was 100-200 blood sugar range. Increase insulin, April/May sugar levels went to hyperglycemia and having to sick insulin. Body swelling leg, foot, and ankle and he is on a lot of medicine and checking to see if in congestion heart failure and upcoming test to check for blood clots.
56 2021-07-27 lymph node swelling Injection site reaction (half-dollar sized), fever >100 , swollen lymph node under left arm x 7 days
56 2021-07-27 lymph node swelling Swollen lymph nodes under both arms, around both sides of neck and in groin; Swollen lymph nodes und... Read more
Swollen lymph nodes under both arms, around both sides of neck and in groin; Swollen lymph nodes under both arms, around both sides of neck and in groin; Swollen lymph nodes under both arms, around both sides of neck and in groin; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the arm left on 16Apr2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 10Mar2021 at 13:30 as a single dose for COVID-19 immunisation. The patient previously received DTaP vaccine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced rash and severe lymph node reaction (not specified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 17Apr2021 at 09:00, the patient experienced swollen lymph nodes under both arms, around both sides of neck and in groin. The clinical outcome of the events swollen lymph nodes under both arms, around both sides of neck and in groin were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
56 2021-07-27 swelling Inability to raise arm without incredible pain; Bruising and swelling from breast to shoulder on rig... Read more
Inability to raise arm without incredible pain; Bruising and swelling from breast to shoulder on right side; Bruising and swelling from breast to shoulder on right side; Kidneys sore; Sick to stomach; Headache; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 01Apr2021 at 16:00 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient previously took flu shot on an unknown date for immunisation and experienced that her body did not tolerate the flu shot. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 04:00, the patient experienced inability to raise arm without incredible pain, bruising and swelling from breast to shoulder on right side, kidneys were sore, sick to stomach and headaches. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events inability to raise arm without incredible pain, bruising and swelling from breast to shoulder on right side, kidneys were sore, sick to stomach and headaches were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
56 2021-07-28 lymph node swelling, lymph node inflammation This is a spontaneous report from a contactable physician (physician). A 56-year-old female patient ... Read more
This is a spontaneous report from a contactable physician (physician). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 09Jun2021 09:30 (at the age of 56-year-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hyperlipidaemia, prediabetes, no prior history of respiratory disease, non-smoker. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX); duloxetine; pantoprazole; and liothyronine. Historical vaccine included BNT162B2 dose 1 on 09May2021 at 09:30 AM (at the age of 56 years old) in the left arm for COVID-19 immunization. The patient was not pregnant. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She had no known allergies. It was reported that on 09Jun2021 09:30, the patient had immediate pain, soreness injection site. On 09Jun2021 21:30, 12 hours post injection the patient had chills, body aches, headache and nausea. On 11Jun2021, 48 hours post injection, she had ipsilateral auxiliary and supraclavicular adenopathy. In Jun2021, 4-5 days post injection, she had substernal chest discomfort radiating to back, continued nausea/chills/headache. In Jun2021, 18 days post injection with continued symptoms seen in ER and diagnosed with RLL pneumonia/pneumonitis. She was treated with antibiotics. 2 weeks later (2021) still same symptoms but now episodic coughing and more shortness of breath. Diagnosed with viral syndrome and placed on albuterol inhaler and prednisone. No resolution to date. No prior history of respiratory disease, no smoker. She had been tested for COVID-19 since the vaccination which included PCR (nasal swab) test with negative result on 12Jul2021. The events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events including antibiotics, prednisone, and albuterol inhaler. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
57 2021-01-04 peripheral swelling some swelling on the underside of this same arm; This is a spontaneous report from a contactable con... Read more
some swelling on the underside of this same arm; This is a spontaneous report from a contactable consumer(patient). A 57-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685) at single dose via an unknown route in her right arm on 20Dec2020 09:50 for Covid-19 immunization. Medical history and concomitant drug were not provided. Past drug history included a reaction to an antibiotic, cefadroxil (DURICEF). Patient received her initial Covid-19 vaccine in her right arm and noted some swelling on the underside of this same arm on 21Dec2020. She wanted to know if this might be associated with the vaccine. Patient stated she had that got the vaccine on 20Dec2020 at 9:50AM in the right arm, that on Monday the next day, 21Dec2020, she got this swelling under her arm. Patient stated did not know if it had anything to do with that, wanted to know if it is a side effect. Patient stated that the swelling started on Monday the next day, 21Dec2020. Patient stated the swelling has improved but she was going to the doctor to make sure everything was okay. Patient stated that years ago she had a reaction to an antibiotic, cefadroxil. She asked her doctor if she should get the shot because of that and they told her she should, states this happened like 25 years ago as of 30Dec2020, no details known. Outcome of the event was resolving.
57 2021-01-05 lymph node swelling Lymphadenopathy
57 2021-01-07 peripheral swelling burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swe... Read more
burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swelling in left arm; tingling swelling in left arm; pain left groin left leg with muscle weakness; pain left groin left leg with muscle weakness; vomiting; tiredness; weak; This is a spontaneous report from a contactable Nurse. This 57-year-old female Nurse (patient) received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on 29Dec2020 08:00 (at the age of 57-years) as single dose, Intramuscular in left arm for COVID-19 immunization. Medical history included allergies to penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant. Concomitant drugs included ASA (ASA), Famotidine (FAMOTIDINE), ergocalciferol (VIT D), ascorbic acid (VIT C), zinc (ZINC), magnesium (MAGNESIUM). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not test for COVID-19 after vaccination. On 29Dec2020 15:00 the patient experienced 'Burning Upper Nose/Throat', 'Heart Racing', 'Headache', 'Numbness', 'Tingling Swelling in Left Arm', 'Pain Left Groin Left Leg with Muscle' 'Weakness', 'Vomiting', 'Weak', and 'Tiredness'. The patient did not received treatment as a result of the event. The outcome of event 'Burning Upper Nose/Throat' was recovered on unspecified date, 'Heart Racing' was recovered on an unspecified date, 'Headache' was recovered on unspecified date, 'Numbness' was recovered on unspecified date, 'Tingling Swelling in Left Arm' was recovered on unspecified date, 'Pain Left Groin Left Leg with Muscle' was recovered on unspecified date, 'Weakness' was recovered on unspecified date, 'Vomiting' was recovered on unspecified date, 'Weak' was recovered on unspecified date, and 'Tiredness' was recovered on unspecified date. Information on the lot/batch number has been requested.
57 2021-01-08 swelling Headache, Fever fatigue, pain, swelling, redness at injection site. left jaw and left axilla pain. l... Read more
Headache, Fever fatigue, pain, swelling, redness at injection site. left jaw and left axilla pain. left rib pain radiating to the back
57 2021-01-10 lymph node swelling headache swollen glands in throat injection site soreness
57 2021-01-10 lymph node swelling left sided axillary and cervical lymphadenopathy
57 2021-01-10 lymph node swelling injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, l... Read more
injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, lymphadenopathy, blurry vision, dizziness; Tylenol 1 tab X 3 times per day during 3 days
57 2021-01-10 lymph node swelling Sore throte, headache, body aches, wet couph, glands are swollen, and runny nose
57 2021-01-10 lymph node swelling Body Aches, headache, Swollen Lymph nodes
57 2021-01-10 peripheral swelling, anaphylactic reaction Her voice became raspy, she could hardly talk, she could barely talk; her hand and whole arm swelled... Read more
Her voice became raspy, she could hardly talk, she could barely talk; her hand and whole arm swelled up; her hand and whole arm swelled up; Trouble breathing; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EK9231, exp date Apr2021), via an unspecified route of administration in the right arm, on 29Dec2020, at single dose, for COVID-19 immunization and diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration, at unknown posology, on 29Dec2020 (20 minutes prior to taking bnt162b2), for anaphylactic reaction. Medical history included ongoing thyroid disorder. Concomitant medications included apixaban (ELIQUIS), diltiazem (unknown trade name), losartan (unknown manufacturer), rosuvastatin calcium (CRESTOR), levothyroxine (unknown trade name), ongoing levothyroxine sodium (SYNTHROID) for thyroid disorder and metformin (unknown trade name). Previously the patient received unspecified influenza vaccine (reported as flu shot) for immunisation, on unspecified date, and experienced anaphylactic reaction treated with Benadryl. On 29Dec2020, an hour after getting the vaccine, the patient experienced her voice became raspy, she could hardly talk, she could barely talk with outcome of unknown, her hand and whole arm swelled up with outcome of unknown, trouble breathing with outcome of unknown. The reporter stated that her voice and everything reacted and made her go to the emergency room on 29Dec2020. She reported that had adverse effect more than normal. The event "Her voice became raspy, she could hardly talk, she could barely talk" caused patient's hospitalization on unknown date. The action taken as a result of the events with diphenhydramine hydrochloride was post-therapy. Therapeutic measures were taken at the emergency room as a result of the events and included treatment with Topcid and Benadryl every 6 hours, 2x 40 mg of steroid. The information on the lot/batch number has been requested. Follow-up (02Jan2021): New information received from the same contactable healthcare professional reporting for herself includes: patient's details, medical history, events updated, vaccine lot# and exp date, concomitant, seriousness of event "Her voice became raspy, she could hardly talk, she could barely talk" added as hospitalization, historical vaccine, suspect Benadryl details, therapeutic measures updated.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
57 2021-01-10 peripheral swelling HEALTH CARE WORKER ARMS WAS SWOLLEN , ITCHY, HARD AND PAINFUL AFTER SECOND DOSE OF GETTING PFIZER C... Read more
HEALTH CARE WORKER ARMS WAS SWOLLEN , ITCHY, HARD AND PAINFUL AFTER SECOND DOSE OF GETTING PFIZER COVID-19 VACCINE
57 2021-01-10 swelling Swollen knuckle at base of left thumb, pain when touched, pain with moving at first, including if ma... Read more
Swollen knuckle at base of left thumb, pain when touched, pain with moving at first, including if making a fist. Now pain when holding a mug or glass but not other movement. Still swollen at time of report 1/11/2021 but much less painful. On the 28th and 29th of December I took 200mg ibuprofen, 3 or 4 doses over the two days, with some benefit.
57 2021-01-11 c-reactive protein increased Patient had mild bilateral knee and hip pain 1 month ago, then she received her 1st dose of COVID va... Read more
Patient had mild bilateral knee and hip pain 1 month ago, then she received her 1st dose of COVID vaccine on 12/14/20. Her joint pain worsened then on 1/4/21 she received her 2nd dose of COIVD vaccine on 1/4/21 and then her pain increased in spread up to her shoulders. She was seen at immediate care on 1/11/21 because her joint pain had worsened throughout and her shoulder pain was making it difficult to raise her arms above the level of her shoulders. Her pain was made worse w/ movement.
57 2021-01-12 swollen extremities 1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red ... Read more
1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red swollen arms, dizziness, blurred vision, gastrointestinal symptoms, blood sugar 143, blood pressure 86/40, pulse 87, oxygen 88. We gave diphenhydramine 50mg at 2:16 pm. Then at 2:35 pm her symptoms were not improved her blood pressure was 80/40 so we gave one dose of 0.3mg epinephrine by auto-injector and called an ambulance. Post epinephrine her vision improved but her skin was still red and starting to itch. She was talking and said she was feeling a little better. She was taken by ambulance to the hospital for additional treatment. There was not reaction visible at the injection site it appeared to be all systemic.
57 2021-01-13 lymph node swelling Swollen Lymph node in arm pit that has not subsided as of today 1/14/2021
57 2021-01-14 anaphylactic reaction difficulty breathing and stridor; difficulty breathing and stridor; noises on inspiration; dizziness... Read more
difficulty breathing and stridor; difficulty breathing and stridor; noises on inspiration; dizziness; headache; sore throat; Anaphylaxis developed within 2 hours of injection; This is a spontaneous report from a contactable other health professional (patient). A 57-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration in arm left on 08Jan2021 09:00 at single dose for covid-19 immunisation. Medical history included Idiopathic Angioedema, Hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported. Reported Event: Anaphylaxis developed within 2 hours of injection. 9:00 am injection; 9:05 am Developed sore throat, 9:20 am Developed dizziness and headache, 10:00 am developed noises on inspiration, 10:20 am Presented to Emergency Services, 10:40 am IV (intravenous) diphenhydramine (BENADRYL) and dexamethasone (DECADRON), 10:45 am difficulty breathing and stridor, 11:00 am intramuscular Epinephrine, 11:10 am Racemic Epi Nebulizer, 11:20 am Breathing improved, 14:00 Discharged home. The adverse events result in Emergency room/department or urgent care. The outcome of all the events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis reactions considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition included Idiopathic Angioedema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-01-14 peripheral swelling Mild reaction; Left arm swelling; This is a spontaneous report from a contactable nurse. A 57-year-... Read more
Mild reaction; Left arm swelling; This is a spontaneous report from a contactable nurse. A 57-year-old female nurse reported for herself that received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0142, Expiry Date 31Mar2021), intramuscular into the left arm on at single dose on 05Jan2021 for COVID-19 immunization. The patient's medical history was none and the patient did not receive other products. The patient reported that when I received the vaccination she patient experienced mild reaction left arm swelling. She did not had it before this vaccine. At the time of reporting it is gone down now. She did not take any treatment.
57 2021-01-14 peripheral swelling Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt ... Read more
Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt swollen, especially the right. Within a few more hours my arm became heavy and I had some general muscular achiness. By approximately 11pm I had intense muscular pain on the back of my legs making it difficult to stand. It felt like I had been hit repeatedly with 2x4s. About that time my posterior ribcage hurt also. I couldn't sleep, turning frequently as my hips hurt. This is what I felt like when I had COVID. Intense pain. At 0630 (1/14) I got out of bed and felt I was going to faint, was extremely nauseous (I did not vomit) and had a very bad, global headache. I had to lay down again. My temp was 100.1 orally. I could not go to work. I was able to take Tylenol. It helped the pain but two hours later my temp was 100.8. I could not get out of bed until 6pm, I felt delirious when I tried. I was able to go to work on 1/15. Of note, following my first dose of COVID vaccine (Pfizer BioNtech Lot #EH9899 on 12/23/20) I had site soreness, heaviness of my left arm, T of 99.5 same day (about 10-12 hours post vaccination), and mild body aches for about a day.
57 2021-01-16 peripheral swelling I noticed pruritic erythematous papules on my right little finger as I woke up the next morning (6:0... Read more
I noticed pruritic erythematous papules on my right little finger as I woke up the next morning (6:00 am) after the vaccine. The affected area has increased in size (about 2.5 x 1 cm now), and the finger is slightly swollen, with pain in the proximal interphalangeal joint when pressure is applied. Two days ago (1/15/2021; 8 days after vaccination), a small pruritic purple papule (2-3 mm) appeared on my ring finger over the distal interphalangeal joint, same hand, and the area is slightly painful when pressure is applied; today, the papule measures 3 x 5 mm. Skin lesions in both fingers are on the dorsal surface. I will seek medical attention.
57 2021-01-17 lymph node swelling Right axillary lymphadenopathy/pain one day after 2nd vaccination x3 days. Resolved.
57 2021-01-17 oral herpes Fever, Chills, Headache, Body aches, cold sore after 48 hours
57 2021-01-18 lymph node pain, lymph node swelling SWOLLEN, PAINFUL LYMPH NODES, UNDER CHIN, OVER COLLAR BONE AND AT BASE OF SCULL BEHIND LEFT EAR . ... Read more
SWOLLEN, PAINFUL LYMPH NODES, UNDER CHIN, OVER COLLAR BONE AND AT BASE OF SCULL BEHIND LEFT EAR . ALL ON LEFT SIDE. NODE OVER COLLAR BONE IS VERY PAINFUL TO TOUCH AN D VERY SWOLLEN
57 2021-01-20 swelling face At 10am feel hot, took temp was 102.7; At 10am feel hot, took temp was 102.7/ Temp at 12am was 101; ... Read more
At 10am feel hot, took temp was 102.7; At 10am feel hot, took temp was 102.7/ Temp at 12am was 101; Red all over; Face swelling; Shot site was red; Allergic reaction; Hives; Around 8pm start to feel chill; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: el1284), via an unspecified route of administration on 09Jan2021 09:30 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included HTN, GERD, IBS, known allergies: PCN, IV contrast. Concomitant medications included lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN), linaclotide (LINZESS). The patient previously took morphine and percocet [oxycodone hydrochloride;paracetamol]; and experienced known allergies. The patient received first dose of bnt162b2 on 19Dec2020 09:30 at right arm. Lot number: el1284. The patient got the 2nd shot at 09:30, went back to work was fine, got home at 07:15pm, around 8pm on 09Jan2021 start to feel chill. On 09Jan2021 20:45, the patient was reported to be red all over, took 650 of Tylenol. Face swelling, the shot site was red. Went to bed at 9pm. Temp at 12am was 101. Went to the ER 12:50am. They stated the patient was having allergic reaction and hives (reported as 09Jan2021 20:45). The ER gave the patient Benadryl IV, Prednisone IV, Pepcid. They discharge the patient with Prednisone and Pepcid. On 10Jan2021 at 10am feel hot, on the same day took temp was 102.7. The patient had to miss work 1 day of work sunday 10Jan2021. The patient received treatment for the events. The patient visited the ER for the events. The outcome of the events was recovering.
57 2021-01-21 anaphylactic reaction, lymph node swelling Patient had vaccine at 1430. At 1600, patient returned to vaccine clinic complaining of swollen glan... Read more
Patient had vaccine at 1430. At 1600, patient returned to vaccine clinic complaining of swollen glands and feeling of potential throat swelling, asking for benadryl. Patient states she has had an anaphylactic reaction in the past, but never to a vaccine or medication. Vital signs taken - BP 166/90, pulse 103, SpO2 100%. Patient monitored for few minutes and continued to feel additional tightness in her throat. Crisis nurse called and patient transported to ED for further evaluation. diphenhydramine 25mg PO given in ED at 1838. Pt reports self taking ibuporfen 600mg at 1535. She has had anaphylaxis in the past 5 years ago to food (treated with solumedrol and benadryl) and once walking thorugh the park>25 years ago an
57 2021-01-23 lymph node swelling, swelling Around 3 am on 1/18/2021 I woke up with a very sore lymph node on my lower head left side. Within a... Read more
Around 3 am on 1/18/2021 I woke up with a very sore lymph node on my lower head left side. Within a few hours lympnodes in my neck, behind my ear and on my collar bone were all swollen and painful. On Wednesday 01/20/2021 I developed hives on my scalp, in my left ear, and on and around all swollen lymph nodes. I left work on 1/20, still couldn't go to work 1/21 on 1/22 I saw Dr. Who have me a shot of Kenalog and some triamcinolone cream for hives. I tried to work, but only lasted 4 hrs and went home. It is now one week since vaccine number two and on top of still raw spreading hives, and swollen glands , I now have a sharp pain constantly shooting through my left temple which is relentless. I am miserable.
57 2021-01-24 lymph node pain Tingling and numb tongue and lips; Tingling and numb tongue and lips; loss of sensation to my right ... Read more
Tingling and numb tongue and lips; Tingling and numb tongue and lips; loss of sensation to my right entire side from the back of my head, face and down to my right foot, which included my back scapular region and both right extremities; sore tender lymph nodes under right arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 08Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included COVID-19 prior vaccination. Concomitant medication included levothyroxine. The patient previously took essential oils and experienced known allergies. The patient experienced tingling and numb tongue and lips, loss of sensation to her right entire side from the back of her head, face and down to her right foot, which included her back scapular region and both right extremities. Also, sore tender lymph nodes under right arm. All events started from 08Jan2021. This has been going on for 4 days as of 12Jan2021. No other vaccine in four weeks. Covid test done post vaccination: nasal swab on 12Jan2021, pending result. The outcome of the events was unknown. Information about lot/batch number has been requested.
57 2021-01-24 lymph node swelling I received the second dose on 1/20/2021 at 630 am. I felt very fatigued on 1/21/2021 and slept most... Read more
I received the second dose on 1/20/2021 at 630 am. I felt very fatigued on 1/21/2021 and slept most of the day, and at 730 pm I noticed a large, moveable, painful swollen lymph node above my left clavicle .
57 2021-01-24 lymph node swelling Elevation of the lymph node in the left armpit with tenderness
57 2021-01-24 lymph node swelling Supraclavicular lymphadenopathy
57 2021-01-24 lymph node swelling Patient called Occ Health Office on 1/21 and was advised to be seen by HCP given the length of time ... Read more
Patient called Occ Health Office on 1/21 and was advised to be seen by HCP given the length of time that had passed since she received the vaccine. She was seen in urgent care. Notes from that encounter states, "...presents for swollen lymph nodes x 3 days, received second covid vaccine on 1/13/21 and had dental procedure that day, just finished bactrim. Physical exam as above; non-toxic, well-appearing, afebrile in NAD. Cervical adenopathy present along with L>R inguinal lymphadenopathy, bilateral inguinal lymphadenopathy. She has received the second covid vaccination and this seems consistent with post vaccination adenopathy. No dental abscess/infection or evidence of tonsillar exudates to suggest strep pharyngitis. Upon discussion with ED staff physician, she reports she has been working excessively and feels fatigued. She was encouraged to take the day off of work today and was given a work note. Encouraged PCP follow up to ensure improvement in symptoms. The ER research team was contacted and will chart review and follow up regarding adenopathy after second covid vaccine. Reviewed return to ED precautions. In ED labs were drawn, EE was given Ibuprofen and advised to follow up with PCP is symptoms persist or worsen.
57 2021-01-25 peripheral swelling Sat. 1/23 knuckles very red, Sun. 1/24 Knuckles red and dry, Mon 1/25 Knuckles red and swollen, no ... Read more
Sat. 1/23 knuckles very red, Sun. 1/24 Knuckles red and dry, Mon 1/25 Knuckles red and swollen, no pain. Tues. 1/26 had 30 seconds where it was hard to breathe, "like gasping for air".
57 2021-01-27 lymph node swelling Received vaccine on Friday morning 1/8/21. On Sunday evening 1/10/21 noticed a lump on left collarb... Read more
Received vaccine on Friday morning 1/8/21. On Sunday evening 1/10/21 noticed a lump on left collarbone area. Saw CRNP on the afternoon of 1/11/21. She examined and felt it was an enlarged lymph node. Order ultrasound which was performed 1/18/21 and bloodwork. Awaiting results from all testing. Lump is still present at this time.
57 2021-01-27 lymph node swelling malaise, generalized myalgias, low grade temp (99.2) noted 1/24/21, lasting 12 hrs. Left sided cerv... Read more
malaise, generalized myalgias, low grade temp (99.2) noted 1/24/21, lasting 12 hrs. Left sided cervical adenopathy noted 1/25/21, persisting.
57 2021-01-28 lymph node swelling Neck pain/tenderness, Shoulder tenderness moving to right side, lymphadenopathy
57 2021-01-28 swollen extremities fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected ar... Read more
fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected arm); numbness in hand (vaccine affected arm) with edema of hand; broke all the blood vessels in both eyes; O2 saturation's dropped to 86%; Headache within 1 hour; This is a spontaneous report from a contactable nurse. A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on arm right from 14Jan2021 12:00 to 14Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation. Medical history included End-Diastolic Heart Failure, osteopenia and arthritis. Concomitant medication included losartan, furosemide (LASIX [FUROSEMIDE]), metronidazole (FLAGYL [METRONIDAZOLE]) and omeprazole. The patient took his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), from 22Dec2020, 09:00 AM to 22Dec2020, 09:00 AM on Left arm (patients age: 57 years). The patient previously took tetracycline and erythromycin and had known allergies. On 14Jan2021, the patient had headache within 1 hour, then also on 14Jan2021, at 23:00 the patient also had fever 103.9F at 12 hours, constant coughing, O2 saturation's dropped to 86%; broke all the blood vessels in both eyes; severe body pain; numbness in hand (vaccine affected arm) with edema of hand. Outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events broken blood vessel in eye and oxygen saturation low. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-01-28 peripheral swelling increased heart rate after that it started getting worse; a warm feeling in her chest like tingling;... Read more
increased heart rate after that it started getting worse; a warm feeling in her chest like tingling; kind of short of breath; left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand; Chills; Fatigue; GI problems; still have some issue, did not feel good, off and on; SARS Covid antibodies test says positive; This is a spontaneous report from a contactable other nurse (patient) from a Pfizer sponsored program Pfizer First Connect. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose (lot number: EJ1685) on Deltoid Left for covid-19 immunisation. Medical history included Paroxysmal supraventricular tachycardia. The patient's concomitant medications were not reported. The patient experienced a warm feeling in her chest like tingling; kind of short of breath, it went away like she said it was just breath it was like for couple of minutes and then it went away and then she was just fine till it's been long here honestly about 3 or 4 days later; got shot in her right arm but left hand start swelling up first a little bit and then her left arm start swelling up and it's just and then that's the base and then her right hand start very, very mild swelling in her right hand. The hospital think there as some clot or something weird but she did not and then that started going down after that it just started going down and went away and never had swelling since then but this was going to long but this was something weird happened to her. She got chills, She got fatigue. She had increased heart rate after that it started getting worse. She had Paroxysmal supraventricular tachycardia, she had that always but it's been control. She walked 5 miles daily a day, she was in shape, she had lot since then, so it's been under control, she never had problem with it until after she got the shot, her heart rate was she had to add medication, she never have to add. She took metoprolol (Treatment) so she added that and she added more and that's thing get it under control and then she take herself back off because she felt like it was under control but she had GI problems since, now she was getting better now, still have some issue, did not feel good, off and on. The patient underwent lab tests and procedures which included blood test: good on 04Jan2021 (blood work to see if something was going on to her heart, because she had short breath, and everything was good), weight: 166 or 164, SARS Covid antibodies test IgM on 04Jan2021: positive. Treatment: Nurse stated, "No, not now, I had a heart-rate monitor, it's what for see what is my heart rate, to locate and see what's going on." Outcome of left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand was recovered.; Sender's Comments: There is not a reasonable possibility that event heart rate increased is related to BNT162B2. The event is most likely due to underlying paroxysmal supraventricular tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-02-02 oral herpes, lymph node swelling Jan 28 4:30am - woke up to excruciating muscle pain in left leg. As the day progressed, I had the f... Read more
Jan 28 4:30am - woke up to excruciating muscle pain in left leg. As the day progressed, I had the following symptoms: injection site pain, fatigue, headache, muscle pain, chills, fever (ranging from 100.3 to 101.7) nausea, swollen lymph nodes Jan 29 achy, chills, headache, injection site pain, swollen lymph nodes, trouble falling asleep Jan 30 - headache, throat hurt, achy, slight sniffles, got a cold sore, ear pain, trouble falling asleep Jan 31 - ear pain, headache, slight aches, trouble falling asleep Feb 1 - feeling better, some ear pain, trouble falling asleep
57 2021-02-03 swelling face Received my 1st Pfizer vaccine 1/10/2021. Did great! Received my 2nd Pfizer vaccine 1/31/2021 1130... Read more
Received my 1st Pfizer vaccine 1/10/2021. Did great! Received my 2nd Pfizer vaccine 1/31/2021 1130 am 6 hours later at 6:30 pm ate packaged veggie dumplings and 15 min later my tongue swelled and my face felt swollen and itchy. Took Benadryl 25mg, Allegra 180mg and Pepcid 20mg with relief. 6 hours later, awoke with itchy throat and face and took Benadryl 25mg with relief. Next morning, 2/1/2021: 8 am ate my regular breakfast of peanut butter on toast and 15 minutes later my face started itching. Took Allegra 180mg with relief. 11:30 ate pretzels and face started itching `15 minutes later. Everything I ate that day caused me to itch 15 min afterwards just like when I would have food reactions when first diagnosed with Alpha Gal and my IGE histamine levels with 3x normal. I increased my Allegra 180mg to 3x a day for 24 hours and Pepcid 20mg to 2x a day for 24 hours. 48hours after vaccine I was able to decrease Allegra 180mg to 2x a day with Pepcid 20mg to 2x a day and was able to eat bland food without itching afterwards. My allergist felt the 2nd vaccine may have caused an inflammatory response and flared up my alpha gal symptoms.
57 2021-02-03 swelling Report of body aches, fever, swelling, dry throat, redness and pain at the injection site day 1 pos... Read more
Report of body aches, fever, swelling, dry throat, redness and pain at the injection site day 1 post vaccination. Treatment: Tylenol, Outcome: no improvement does not interfere with ADLs.
57 2021-02-05 lymph node pain Fever of 100, nausea, injection site pain, lympnoid pain right side into right breast, stiff neck, ... Read more
Fever of 100, nausea, injection site pain, lympnoid pain right side into right breast, stiff neck, all over pain ,achness, headache, fatigue and all over chills. Took tylonal and went to bed for 14 hours. Still experiencing pain, slight headache and achness all over. Fever and nausea gone.
57 2021-02-05 lymph node swelling Swollen and painful lymph nodes in armpit of left arm
57 2021-02-05 peripheral swelling RUE 4 in x 4 in large, painful, raised area that has decreased in size and pain but still remains.
57 2021-02-10 swelling face Blood pressure was also a little elevated on 22Jan2021, 196/106/ 179/101 on 27Jan2021; severe left ... Read more
Blood pressure was also a little elevated on 22Jan2021, 196/106/ 179/101 on 27Jan2021; severe left facial swelling; facial abscess; This is a spontaneous report from a contactable health care professional (nurse practitioner). A 57-Year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unknown date in Jan2021 for Covid-19 immunization. Medical history included hypertension diagnosed for years as of 27Jan2021, and dental cleaning (also reported unsure if it was after or before vaccine). Concomitant drug was reported as "none". She not sure of the exact date of administration, stated patient came in to the office to be seen on Friday morning, 22Jan2021. Patient told caller at that time that she had the vaccine last week as of 27Jan2021, was seen for severe left facial swelling, onset of symptom was on Wednesday 20Jan2021. She was treated for facial abscess with Clindamycin 300mg 4 x a day for 10 days, she took first dose of treatment on Friday 22Jan2021. She followed up with doctor on 27Jan2021 and was improved, about 75%better. Her Blood pressure was also a little elevated on 22Jan2021 visit, it was 196/106 and on 27Jan2021 it was 179/101, did not know if this related to vaccine or symptoms. Patient reported that she went to dentist and had cleaning, unknown exact date of cleaning, unsure if it was after or before vaccine. She stated that doctor thought the symptoms could be due to dental cleaning not the vaccine. Patient went to ENT on Monday 25Jan2021 and they cleared her of anything ENT related from her neck up; scoped her and looked at her sinuses, and everything was fine. The ENT doctors told the patient that it appeared to be a reaction to the vaccine and advised her not to get the second dose. The reporter inquired whether patient should get the second dose. No Investigation Assessment was performed. The event severe left facial swelling was reported as serious with seriousness criteria of other medically important condition. Outcome of the event severe left facial swelling and facial abscess was resolving. Outcome of the other event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the outcome of treatment, the reported events severe left facial swelling, facial abscess, and elevated BP are likely intercurrent medical conditions and are unrelated to suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
57 2021-02-11 lymph node swelling, swelling Swelling, pain, knot in lymph node in underarm of shot arm
57 2021-02-11 lymph node swelling STARTED HAVING AXILLARY PAIN NEXT DAY AND FELT SOME NODE SWELLING BUT IT SLOWLY WENT AWAY. THEN I HA... Read more
STARTED HAVING AXILLARY PAIN NEXT DAY AND FELT SOME NODE SWELLING BUT IT SLOWLY WENT AWAY. THEN I HAD THE SECOND DOSE IN THE SAME ARM AND STARTED PAIN ANS SOME SWELLING BACK TO THE SAME LEFT AXILLA.I HAD BODY ACHES AND TIRED NESS THE NEXT DAY, I TOOK TYLENOL ES 2 TABS.
57 2021-02-13 lymph node swelling Fever, swollen lymph glands, sore throat, fatigue, nausea, vomiting
57 2021-02-13 lymph node swelling Swollen Gland Body Aches headache
57 2021-02-14 peripheral swelling On 1/11/21, the next day the arm was swollen, hot, bruised, and so swollen that she had to use an XL... Read more
On 1/11/21, the next day the arm was swollen, hot, bruised, and so swollen that she had to use an XL shirt, wears M. Had red splotches on it, pain and swelling for 7 days after the vaccine. There was red splotches on the arm, but now 2/15/21 there are now white dots where the red lines used to be. Did not take anything for it, as she did not know what to do. She called her doctor, but they did not address the problem. When she went to work on 1/12/21 had another lady that is a corporate nurse and told her that it was bad. Arm is still hurting, and is in the process of recovering. If she pushes on the location of the vaccine it does hurt. She has not and will not take the 2nd vaccine.
57 2021-02-15 lymph node swelling Swollen painful lymph node under left arm
57 2021-02-16 lymph node swelling Severe migraine pain for 2 days and on second day, severe swelling under the underarm on the right a... Read more
Severe migraine pain for 2 days and on second day, severe swelling under the underarm on the right arm.
57 2021-02-17 peripheral swelling, swelling face, swelling R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; ... Read more
R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; decreased hearing to my R ear; The pain was worse in my R jaw- both upper and lower teeth pain; The pain was worse in my R jaw- both upper and lower teeth pain; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; decreased taste on the R side of my tongue; fatigue; muscle aches; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL 3248, Expiration date: Apr2021), via an unspecified route of administration at the left arm on 14Jan2021 08:15 at a single dose for covid-19 immunization. The vaccine was administered in a hospital. Medical history includes shrimp allergy. The patient was not pregnant at the time of vaccination. Concomitant medication was not reported. Historical vaccine includes 1st dose of bnt162b2 for COVID-19 immunization on 24Dec2020 09:30 AM, at the left arm, Lot number: EK9231 and Expiration date: Apr2021 at age of 57 years. The patient developed extreme fatigue, some muscle aches on 18Jan2021. She woke up with painful (pins and needle sensation) swollen hands. Took some TYLENOL and elevated them for a few hrs. The swelling subsided by the afternoon. On 19Jan2021, she developed R sided neck and facial swelling with nerve pain. The pain was worse in her R jaw- both upper and lower teeth pain, nerve pain extending from the side of my R ear up to my R eye and temple area. Feeling of heaviness to her R eye, R cheek, R side of her tongue, decreased hearing to her R ear (sounds muffled like being under water), decreased taste on the R side of heer tongue. Took benedryl and tylenol all day. On 20Jan2021, after a restless night due to the nerve pain (not relieved by tylenol) went to work but the swelling worsened so she was sent to the ED. They treated me with IV decadron, IV benedry, IV zofran- which immediately took away the swelling. The events result to Emergency Room/ Urgent Care Visit. Prior to vaccination the patient was not diagnosed with COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021, the patient had Nasal Swab, PCR, covid test result was negative. The events were assessed as non-serious by the reporter, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
57 2021-02-19 swollen extremities Shooting pain down entire arm and arm pit. Swelling of armpit, shoulder and elbow, loss of muscle s... Read more
Shooting pain down entire arm and arm pit. Swelling of armpit, shoulder and elbow, loss of muscle strength of entire arm. Inability to move arm. Symptoms continuously got worse for next 5 days. Pain started to decrease on February 6 and symptoms gradually improved over the following week.
57 2021-02-19 swelling face Received 2nd Covid vaccination on 1/6/2021 0830. On 1/9/2021 upon waking up I noticed lips swollen (... Read more
Received 2nd Covid vaccination on 1/6/2021 0830. On 1/9/2021 upon waking up I noticed lips swollen (right upper and left lower) seemed like fluid filled pockets but later lips were completely swollen, the next day my chin became very hard and swollen, no tongue edema noted, no other swelling of face noted. It is now 6 weeks later and I continue to have lip and chin edema. Have been on high dose steroids but rebound within 48 hours. I am currently on antihistamine regimen of Allegra, Singulair, Pepcid and Atarax x one week with continued swelling, although it does lessen throughout the day but every morning I am very swollen despite medication regimen.
57 2021-02-20 lymph node pain Sore tenderness under left armpit and left side of neck. General tiredness and lethargic, mild heada... Read more
Sore tenderness under left armpit and left side of neck. General tiredness and lethargic, mild headache.
57 2021-02-20 sepsis She received 2nd COVID vaccine on 1/7//21. On 1/13/21, she developed sore throat, earache, dizziness... Read more
She received 2nd COVID vaccine on 1/7//21. On 1/13/21, she developed sore throat, earache, dizziness, dyspnea, diarrhea, vomiting and fever. She required hospitalization on 1/18/21 for Acute hypoxic respiratory failure secondary to bilateral Pneumonia with left pleural effusion. Sepsis secondary to Gram-Positive bacteremia (strep pneumococcus). UTI. Acute Kidney Injury
57 2021-02-23 lymph node swelling Patient had second vaccination on 2/19, and later in the evening started to feel achy, and tired, an... Read more
Patient had second vaccination on 2/19, and later in the evening started to feel achy, and tired, and had swelling under arm, that is still there, though it has gone done. She satted it feels like it spread to her breast. She also stated she had a twitching on the side of her mouth that lasted a second. She denies, fever, SOB, chest pain, rash, or any other symptoms. She stated she is taking Tylenol every 6 hours which is helping. RN reviewed red flags to call 911. RN reviewed would folllow up tomorrow with her.
57 2021-02-23 peripheral swelling Days 1-3 pain at site of injection much more than other vaccines that subsided but to this date has ... Read more
Days 1-3 pain at site of injection much more than other vaccines that subsided but to this date has not gone away completely. Low grade fever and fatigue for about a week, lots of sleeping! Mild wheezing and sinus congestion, headaches. Day 4 I developed swelling in the lower legs and feet, that lasted about a week, still some fatigue and ongoing sinus congestion but feeling better, then a few days later in the 2/16 developed sudden onset moderately severe pain and tenderness in the upper right abdominal quadrant in the area of the live, gallbladder and pancreas up near and under the ribs and around to the flank and a small aspect of the back, with abdominal swelling belching and bile diarrhea and indigestion
57 2021-02-23 swelling Weakness to left leg. Swelling to left armpit and left breast.
57 2021-02-24 peripheral swelling General fatigue, severe swelling in arm with pain, hives on scalp with horrible itching, diarrhea, s... Read more
General fatigue, severe swelling in arm with pain, hives on scalp with horrible itching, diarrhea, stomach pain, severe back pain, nausea.
57 2021-03-01 lymph node swelling injection site pain, injection site swelling, muscle pain, chills, swollen lymph nodes, nausea
57 2021-03-02 lymph node swelling high fever 101 or something; her armpits and lymph nodes were very swollen.; her hand was kind of he... Read more
high fever 101 or something; her armpits and lymph nodes were very swollen.; her hand was kind of heavy; This is a spontaneous report from a contactable nurse (patient) reported that a 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on the left arm on 28Jan2021 at a single dose for Covid-19 immunization. The patient medical history included that she was diabetic, and she have had COVID and she have been in long term for COVID from Jul2020 and unknown if ongoing. Concomitant medication included metformin. The patient received the vaccine on Thursday morning (28Jan2021) and the next day (29Jan2021), her hand was kind of heavy and that night through Saturday (30Jan2021). On an unspecified date, the patient spike very high fever 101 (no unit reported) or something all through non-stop; her armpits and lymph nodes were very swollen. As treatment, patient took Tylenol for the events. The outcome of her hand was kind of heavy was recovered on 30Jan2021, high fever 101 or something was unknown, and armpits and lymph nodes were very swollen was not recovered. The patient stated that she would like to be tested for her immunity before receiving her second dose since she thought that she still have low immunity from Jul2020 because she have been in very long term of Covid.
57 2021-03-03 lymph node swelling reports having soreness in left arm at site of injection site. developed loss of appetite that afte... Read more
reports having soreness in left arm at site of injection site. developed loss of appetite that afternoon after receiving vaccine. noticed shortness of breath while walking the dog. sunday evening, developed left axillary lymph node swelling. also with fever 99.8 - 100.2 degrees F. had night sweats saturday evening (2/27/2021 PM). also with headache after vaccine.
57 2021-03-03 swelling Swollen neck area now about 5 cm diameter. Has increased over time. Back of neck - starts at base of... Read more
Swollen neck area now about 5 cm diameter. Has increased over time. Back of neck - starts at base of skull just under hairline. Tender to touch. Limits mobility range (hard to turn head, tilt forward and back). Started with small 1m area Sunday night on 2/28 and has continued to grow. No fever. No pain anywhere else on body
57 2021-03-04 swelling became very sore under my armpit and now it is very swollen and sore; became very sore under my armp... Read more
became very sore under my armpit and now it is very swollen and sore; became very sore under my armpit and now it is very swollen and sore; This is a spontaneous report from a contactable other health professional (patient). A 57-year-old non-pregnant female patient received second dose of BNT162B2 (Solution for injection, Batch/Lot number: 9262) via an unspecified route of administration in the left arm on 31Jan2021 at 09:15 (at the age of 57-years-old) as a single dose for Covid-19 immunisation. Medical history included diabetes. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included metformin hydrochloride/sitagliptin phosphate monohydrate (JANUMET) and rosuvastatin. The patient previously received first dose of BNT162B2 in left arm on 10Jan2021 at 01:15 PM for Covid-19 immunisation. The patient stated two days after 2nd vaccine, 02Feb2021, she became very sore under her armpit & now it was very swollen and sore. Seriousness criteria was considered as non-serious. No treatment was received for the adverse events. The outcome of the events was not recovered.
57 2021-03-05 lymph node swelling I began running a fever 3/2 of 101, notice swelling in lymph nodes on right side of neck. Trouble sw... Read more
I began running a fever 3/2 of 101, notice swelling in lymph nodes on right side of neck. Trouble swallowing. Fever escalated to 103 at 1am 3/3. By 9am 3/3 neck was much more swollen and swallowing more difficult. By 3/4 fever down to 101.3 but throat so swollen difficult to talk, drink, unable to eat. Went to ER at 3:30pm 3/4.
57 2021-03-05 swollen extremities Rash to neck and left hand dorsum at digits 3,4 with mild edema and itching. Symptoms started about ... Read more
Rash to neck and left hand dorsum at digits 3,4 with mild edema and itching. Symptoms started about 24 hours moted to have rash on right side of neck that developed into two papules by the next day, 36 hours after vaccine started with rash to dorsum of right hand at digits 3,4 with mild edema at base of fingers.
57 2021-03-06 swelling First does given 2/5/2021 no reactions except sore arm next day Second dose given 3/5/2021 Headache ... Read more
First does given 2/5/2021 no reactions except sore arm next day Second dose given 3/5/2021 Headache next day and on 3/7/2021 now have swollen knot on left side of neck, area around somewhat swollen as well.
57 2021-03-07 lymph node swelling, lymph node pain painful, swollen lymph nodes in armpit of right arm. feeling much better today, 3-8-21, but pain not... Read more
painful, swollen lymph nodes in armpit of right arm. feeling much better today, 3-8-21, but pain not completely gone. ibuprofen and acetominophen used to treat.
57 2021-03-07 peripheral swelling, c-reactive protein increased Vaccine received from off site facility. Unknown site or lot number. Patient started to experience... Read more
Vaccine received from off site facility. Unknown site or lot number. Patient started to experience joint pain the evening of vaccine. Joint pain leading to joint swelling in both knees, wrist and elbow. No fever. Lower leg swelling. Complaint of extreme pain.
57 2021-03-08 anaphylactic reaction Anaphylaxis - rash and hives from head to toes, severe itching, difficulty breathing, and chest pain... Read more
Anaphylaxis - rash and hives from head to toes, severe itching, difficulty breathing, and chest pain. Oxygen Saturation was at 87 when I arrived. Treated with dexamethasone sod phosphate PF last given at 5:45 PM, diphenhydrAMINE (Benadryl) last given at 5:45 PM, EPINEPHrine last given at 5:45 PM, famotine last given at 6:08 PM, GI cocktail oral suspension last given at 6:44 PM, hydrocortisone last given at 8:18 PM, LORazepam last given at 5:48 and 6:45 PM, ondansetron last given at 5:48.
57 2021-03-09 lymph node swelling Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild,... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient did not have any anaphylaxis, main complaint was mild tightness under chin between jaw and lymph nodes 20 minutes post immunization lasting for a max of 30 minutes. Also mild tingling in forearm a few minutes after injection.
57 2021-03-09 swelling fever; chills; back pain; injection site redness w/ itching & heat; injection site redness w/ itchin... Read more
fever; chills; back pain; injection site redness w/ itching & heat; injection site redness w/ itching & heat; injection site redness w/ itching & heat; injection site redness w/ itching & heat; swelling under arm; head ache; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: F19264), via an unspecified route of administration on 05Feb2021 09:45 at a single dose for COVID-19 immunization. The patient's medical history included hypothyroidism and sulfer allergy. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID) and rosuvastatin. The patient previously took the first dose of bnt162b2 (lot number: EL1283) in the right arm on 15Jan2021 at the age of 57 years old for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 05Feb2021 20:30, the patient experienced fever, chills, back pain, injection site redness with itching and heat, swelling under arm, and head ache. No treatment was received for the adverse events. Outcome of the events was recovering.
57 2021-03-11 lymph node swelling Increase in arthritis/joint pains starting day after vaccine; Intermittent headaches. 12 days after... Read more
Increase in arthritis/joint pains starting day after vaccine; Intermittent headaches. 12 days after vaccine, patient donated blood. 13 days after vaccine with chills, fatigue, body aches, headache, feeling feverish, but normal temperature, right neck gland swollen
57 2021-03-14 swelling . Caregiver for my 78 y/o Day 1: 3/9/21 - low grade headache. Day 2: 3/10/21 - headache stronger (... Read more
. Caregiver for my 78 y/o Day 1: 3/9/21 - low grade headache. Day 2: 3/10/21 - headache stronger (took Tylenol); Day 3: 3/11/21 - debilitating headache. Couldn't work. Eyes hurt. Headache felt like hammers hitting the side of my head. I was so concerned I wanted to go to the hospital. The headache stopped around 2pm on March 11. Day 5: 3/14/21 - face has welts on my left cheek (shot was in the left arm).
57 2021-03-14 swelling, swelling face Severe itching, hives, facial and neck swelling, breathing trouble
57 2021-03-15 swelling face Developed itching and swelling of face and tongue, confirmed SOB.
57 2021-03-15 swelling Had a shingles outbreak on left mid/lower back. Reddened raised lesions, pain & itching. Prescribe... Read more
Had a shingles outbreak on left mid/lower back. Reddened raised lesions, pain & itching. Prescribed Acyclovir for 10 days. Symptoms subsided over time. Some residual itching at times still
57 2021-03-18 lymph node swelling Swollen lymph nodes on right side of neck, top of ear, down side of face, down to collar bone, some ... Read more
Swollen lymph nodes on right side of neck, top of ear, down side of face, down to collar bone, some soreness in armpit
57 2021-03-18 peripheral swelling Itchy face, red inflamed and itchy hands, ringing of the ears
57 2021-03-19 peripheral swelling My arm 2 days after the second dose started to itch terribly and became red and swollen
57 2021-03-20 lymph node swelling, lymph node pain lymph node under left arm down to the left breast was swollen and painful; body aches; weak; lymph n... Read more
lymph node under left arm down to the left breast was swollen and painful; body aches; weak; lymph node under left arm down to the left breast was swollen and painful; temp of 99.4 to 99.9; chills; joints ached; fatigued; With in 3 hours of injection, I got hot and flushed in my face; This is a spontaneous report from a contactable nurse (patient). A 57-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not available) via intramuscular on right arm on 13Jan2021 14:15 (02:15 PM) (at the age of 57-years-old) at single dose for COVID-19 immunisation at Workplace clinic. The patient's medical history included Asthma and Arthritis. The patient had allergies to medications, food, or other products (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. Historical vaccine included first dose of influenza vaccine at the age of 57 years in nasal on 02Dec2020 which was given within 4 weeks prior to the COVID vaccine and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown via intramuscular on left arm on 23Dec2020 14:15 (02:15 PM) (at the age of 57-years-old) at single dose for COVID-19 immunisation. On 13Jan2021 at 17:00 (05:00 PM), within 3 hours of injection, the patient got hot and flushed in her face. The next morning on 14Jan2021, she woke up and her lymph node under left arm down to the left breast was swollen and painful. The patient also had a temperature of 99.4 to 99.9 and had chills and body aches enough to keep her home from work. The patient had joints ache and felt weak and fatigued. This lasted for about twenty-four hours. The reporter assessed the events as non-serious. The outcome of the events was recovered in Jan 2021. Information regarding lot/batch number has been requested.
57 2021-03-21 swelling Skin redness and minor swelling. 25mg Benadryl PO
57 2021-03-22 lymph node swelling Headache, Myalgia, Arthralgia, Nausea Vomiting, INECTION SITE PAIN, SWOLLEN GLANDS
57 2021-03-22 swelling face Patient presented with progressive facial swelling and shortness of breath
57 2021-03-23 lymph node swelling rash, red hot under shot arm. Swollen glands under shot arm
57 2021-03-23 peripheral swelling Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Inject... Read more
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Redness and swelling of both arms starting at wrists and itching on left arm. Subsided after about 45 minutes. Advised Benadryl, but wanted to wait until she got home as she had a bit of a drive and didn't want to drive drowsy.
57 2021-03-23 swelling face, lymph node swelling complete insomnia I can go 3 days without sleep and try all kinds of medication and nothing works, s... Read more
complete insomnia I can go 3 days without sleep and try all kinds of medication and nothing works, sinus problems worse then before and headaches and sore body. right now the sides of my face feels swollen and my lymph nodes are swollen
57 2021-03-23 swelling face Vaccine administered on 3/6/2021. On 3/8/21, symptoms of small fiber polyneuropathy greatly amplifie... Read more
Vaccine administered on 3/6/2021. On 3/8/21, symptoms of small fiber polyneuropathy greatly amplified and continue to present. On 3/12/2021, woke up with left side of face feeling slightly swollen extending from jaw up through eyelid-appearance unchanged, no loss of facial muscle control; sensation still present-has not improved or worsened. This symptom has not been a symptom previously experienced as part of the small fiber polyneuropathy. On 3/14/2021, woke up with upper and lower gums feeling slightly swollen across entire expanse (left and right); sensation still present-has not improved or worsened. This symptom has not been a symptom previously experienced as part of the small fiber polyneuropathy.
57 2021-03-24 swelling Initially intense headache, body aches, irritability, chills followed by severe angioedema of lips a... Read more
Initially intense headache, body aches, irritability, chills followed by severe angioedema of lips and face with urticaria
57 2021-03-24 lymph node pain, peripheral swelling Heart shaped rash appeared 6" below injection site; excruciating lymph node pain; pain in tricep, un... Read more
Heart shaped rash appeared 6" below injection site; excruciating lymph node pain; pain in tricep, under arm; hard lump at injection site; Swelling down to hand and fingers; 99.3 fever; pain in tricep, under arm; This is a spontaneous report from a contactable healthcare professional (patient). This non-pregnant 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 21Feb2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or concomitant medications. The patient reported she had allergies to medications, food or other products. Prior to vaccination the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number unknown) on 31Jan2021 at 16:00 (at the age of 57-years-old) in the right arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 21Feb2021 at 22:00 the patient experienced a heart shaped rash six inches below the injection site 8 hours after the shot. 10 hours later the patient had excruciating lymph node pain and pain in the tricep, under arm and hard lump at injection site. She also experienced swelling down to hand and fingers and 99.3 fever. The events were reported as non-serious and didn't require hospitalization. No treatment was provided for the events. The clinical outcomes of heart shapes rash six inches below injection site, excruciating lymph node pain, pain in tricep under arm, hard lump at injection site, swelling down to hand and fingers, and 99.3 fever were reported as not recovered. It as also reported that since vaccination the patient had not been tested for COVID-19.
57 2021-03-24 lymph node swelling Swelling of the lymph node under my right arm, which is the arm I received the shot. Significant sw... Read more
Swelling of the lymph node under my right arm, which is the arm I received the shot. Significant swelling and tenderness. No other symptoms.
57 2021-03-24 oral herpes I had had a severe reaction to the flu shot I received on 9/28/21...developed Bell's Palsy. The sym... Read more
I had had a severe reaction to the flu shot I received on 9/28/21...developed Bell's Palsy. The symptoms lasted a few weeks. Most of the symptoms resolved, but I still have areas of weird sensations that has not gone away. For the immediate treatment, I was given a prescription for steroids and was told I shouldn't have any additional problems for future vaccinations. I was scared to get the COVID vaccine thinking I could have another severe reaction, but I was assured it should not happen again. I had the COVID vaccine on 3/10/21. Yesterday, 3/24/21, exactly 2 weeks to the day, I'm feeling like the Bell's Palsy symptoms are returning. I have had a large fever blister on my mouth and one side of my face is feeling somewhat numb.
57 2021-03-25 lymph node swelling Extreme breast pain, both right and left for six days. Swollen lymph glands in both arm pits.
57 2021-03-25 swollen extremities Severe Head ache Body aches Temp spike Chilling Lump under arm
57 2021-03-25 swelling, peripheral swelling, lymph node swelling Bilateral cervical adenopathy: swollen lymph nodes in neck, armpits and groin. Significant, obvious,... Read more
Bilateral cervical adenopathy: swollen lymph nodes in neck, armpits and groin. Significant, obvious, very painful swelling extending around back of neck and down left arm. No sore throat, fever.
57 2021-03-26 lymph node swelling day 2 - Left arm sore - like when you get a tetnus day 3 - whole arm and hand sore, some joint pain ... Read more
day 2 - Left arm sore - like when you get a tetnus day 3 - whole arm and hand sore, some joint pain and fatigue - very tired end of day 3 - Lymph nodes swollen - under left arm 4th day lymph nodes swollen in neck and under arm - left side took Tylenol 2 x a day starting day 2 by 7th day, was no Tylenol needed, lymph nodes gradually went down.
57 2021-03-27 peripheral swelling left scars to her left breast still, that look like white crust on them/scars on her left breast; le... Read more
left scars to her left breast still, that look like white crust on them/scars on her left breast; left scars to her left breast still, that look like white crust on them; bumps on her chest that won't heal up; skin blistered up like shingles centered to her left breast in the middle; spots were white and puffy, and some left a bump around; pain in her left chest still from the middle to her arm down to her elbow; pain goes from her front to the back of her shoulder blade and around; nerve pain; every once in a while she loses her grip with her left hand though not too much and she can grab again what was slipping; bumps on the left side of the chest/still has lumps, some were white and some have busted open; broke out with what thought as a nurse was shingles; arm swelling after the injection; pain/stabbing pain/nagging pain; pain in her arm that went to her chest area/Under her arm and going down she feels a pinching sensation; Her left arm was swollen at the injection site; This is a spontaneous report from a contactable nurse (patient) from the medical information team. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in the left arm on 22Jan2021 at a single dose (at the age of 57-years-old) for COVID-19 immunisation. The patient was given the vaccine in a pharmacy/drug store. Medical history included diabetes and hypertension. There were no concomitant medications. The patient experienced arm swelling after the injection, then a little later on in the day experienced pain. The next day or so, she got bumps on the left side of the chest. Thought it was shingles and was given medicine for shingles but ended up not being shingles. She still has lumps, some were white and some have busted open, approximately 4. She still had arm pain and back. Arm was still swollen. Went back to doctor on 10Mar2021 and gave another round of antibiotics. Still has a stabbing pain from the from to the back. "1 cm to 1.5 cm." She had scheduled for a breast screening done. She was still having pain almost 2 months later. The patient provided further information: the patient only got her first dose of the vaccine. Her side effects began that day then gradually got worse. Her left arm was swollen at the injection site since 22Jan2021 and was still swollen at the time of the report. A couple of hours afterwards as the day went on, she had pain in her arm that went to her chest area. The next day (23Jan2021), she broke out with what thought as a nurse was shingles, but was just in one little spot, so she went to the doctor and gave her medicine, antibiotics, and then she took those for 7 days three times a day. The first antibiotic she was on when they thought it was shingles was azithromycin (ZITHROMAX). After then, the pain would not go away and has left scars to her left breast still, that look like white crust on them. She has pain in her left chest still from the middle to her arm down to her elbow. She has two different types of pain, and when she went back to the doctor a day before (10Mar2021), she was given more antibiotics. The pain goes from her front to the back of her shoulder blade and around and was a stabbing pain. Under her arm and going down she feels a pinching sensation that won't go away, and was all the time. They wouldn't give her the second vaccine dose while she was on antibiotics that appointment reached its due. The pharmacist came on 05Mar2021 which would be her third appointment to get the vaccine and told the pharmacist her reaction to the COVID shot. The pharmacist asked to look at her injury and then wouldn't give the vaccine to her. Her doctor gave her some pain medication that would be good for nerves. She can't take gabapentin and doesn't like to take pain pills for the nerve pain, so she does paracetamol (TYLENOL) and ibuprofen every other time to relieve the pain. She says she has been taking paracetamol 500mg extra strength twice a day by mouth, and ibuprofen 400mg twice a day by mouth. She was wondering if there was any information on if her pain would get better since she doesn't want to stay the same or for it to get worse that what it is. It was a nagging pain that she can't seem to get rid of and every once in a while she loses her grip with her left hand though not too much and she can grab again what was slipping. The gabapentin for her nerve pain gave her side effects, she was taking 300 mg one pill four times a day. She took about three days worth and starting in Feb2021 she thought. The new antibiotic given on 10Mar2021 that she takes for the bumps on her chest that won't heal up was cefdinir 300 mg. She says after her vaccine her skin blistered up like shingles centered to her left breast in the middle, which she thought originally would spread all around but it didn't, it stopped right there. She says that the spots were white and puffy, and some left a bump around in them where they healed up. She says her doctor wanted her to get a mammogram done, which is scheduled for the first Monday in Apr2021. No labs were done, "they just looked at them". The patient felt bumps on the left side of the chest was medically significant because the scars and bumps have been there a while and several were not healing well. The patient has not recovered from the events. Information on the lot/batch number has been requested.
57 2021-03-28 oral herpes A massive cold sore developed on my lower lip. I have not had a flare up like this in years. I'm co... Read more
A massive cold sore developed on my lower lip. I have not had a flare up like this in years. I'm concerned that because I was vaccinated to stop a virus, it is causing my cold sores to flare up? It is unusually painful.
57 2021-03-28 swelling face Patient with onset of facial tingling and sensation of facial swelling and tongue swelling approxima... Read more
Patient with onset of facial tingling and sensation of facial swelling and tongue swelling approximately 10 min after receiving the second dose of her COVID-19 vaccine. This persisted throughout evaluation. She received the first dose of her COVID-19 vaccine 3 weeks prior, without adverse effects. She had progression of symptoms during her evaluation, with some chest pressure, described as a sensation of a brick sitting on her chest, duration approximately 10 min at the time of evaluation, continual, approximately 3/10 on pain scale, persisting chest pressure worse with deep breathing. Oxygen saturations were stable at 95%, anterior breath sounds clear with good air exchange, distant heart sounds. Good peripheral pulses, perfusion difficult to assess since fingertips were cold due to cold external air temperatures. She was transferred from private vehicle to ambulance and oxygen was placed and EKG obtained as below. She was then transferred to hospital for further evaluation. Of note, the patient reported that during the day prior to receiving the second dose of her vaccine, she had worsening shortness of breath with need for supplemental oxygen, 2L by nasal cannula, with activity and at rest. Onset prior to her evaluation after her vaccination. This is above her baseline of nocturnal oxygen use. She was feeling poorly prior to presenting for the vaccine. She had been hospitalized with intubation for CHF exacerbation in the week prior to 2nd dose COVID-19 vaccine administration.
57 2021-03-29 anaphylactic reaction Patient complained of itching, said previous anaphylaxis started with a deep itch. Vitals stable and... Read more
Patient complained of itching, said previous anaphylaxis started with a deep itch. Vitals stable and no shortness of breath. Patient had pre medicated with prednisone and Benadryl. As itching continued urgent care MD ordered epinephrine to be administered
57 2021-03-29 c-reactive protein increased, swelling Bilateral parotid and submandibular gland sialoadenitis ? intense swelling, purulent drainage, pain,... Read more
Bilateral parotid and submandibular gland sialoadenitis ? intense swelling, purulent drainage, pain, overlying skin edema requiring multiple antibiotics (bactrim, azithromycin, clindamycin) and steroids including ER visit
57 2021-03-29 lymph node pain I was tired and lethargic feeling Friday evening then Saturday was basically the same Sunday was the... Read more
I was tired and lethargic feeling Friday evening then Saturday was basically the same Sunday was the worst I felt like I was going to throw up I had pain in my lower right side of my back also pain in my neck lymph node areas also pain in my knees it seems like it targets previous injuries also I had a low-grade fever nauseousness chills couldn't sleep fatigued just terrible feeling this morning is Tuesday March 30th I'm starting to feel better but I still really weak just really weak and my throat has been sore since like Saturday.
57 2021-03-29 swelling face Patient developed fatigue shortly after vaccination. Approximately 3-4 hours after vaccination, she... Read more
Patient developed fatigue shortly after vaccination. Approximately 3-4 hours after vaccination, she developed diffuse facial swelling. There was no dyspnea, tongue swelling, dizziness, hives, itching. She has no history of dermal fillers or other cosmetic facial procedures. She monitored at home, did not seek medical attention. Swelling was resolved by the following morning when she awoke from sleep.
57 2021-03-30 peripheral swelling, lymph node swelling Underarm lymph node swelling; pain; knot on the shot arm only; This is a spontaneous report from a c... Read more
Underarm lymph node swelling; pain; knot on the shot arm only; This is a spontaneous report from a contactable consumer (patient). 57-year-old non- pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), at 57 years of age, via an unspecified route of administration on 10Feb2021; 09:30 at single dose for covid-19 immunization. The patient medical history included Obesity, high blood pressure, asthma and unknown if ongoing. No known allergies. Concomitant medication included Amlodipine Besylate, Atorvastatin and Escitalopram. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Feb2021;06:00 patient experienced Underarm lymph node swelling, pain, knot on the shot arm only. The events were considered as non-serious. No treatment was given for the events. Patient did not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was unknown.
57 2021-03-30 peripheral swelling Approximately 18 hours after shot, woke up with extreme chills; body shaking head to toe; fever of 1... Read more
Approximately 18 hours after shot, woke up with extreme chills; body shaking head to toe; fever of 100.5; Left arm very sore; it was swollen and very red; it was swollen and very red; it feels itchy; This is a spontaneous report from a contactable consumer. This 57-year-old female consumer(patient) reported that:A 57-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247)dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 07:45 asfor covid-19 immunisation .The patient medical history was not reported. The patient experienced approximately 18 hours after shot, woke up with extreme chills on 12Feb2021 01:00, body shaking head to toe on 12Feb2021 01:00 and, fever of 100.5 on 12Feb2021 01:00 and, left arm very sore and on 12Feb2021 01:00 and it was swollen and very red on 12Feb2021 01:00 and , it was swollen and very red on 12Feb2021 01:00 and, it feels itchy on 12Feb2021 01:00 and.The patient underwent lab tests and procedures which included body temperature: 100.5 on , body temperature: 101.9 and Approximately 18 hours after shot, woke up with extreme chills, body shaking head to toe and fever of 100.5 Took 600mg Ibuprofen, an hour later fever was 101.9, took 400mg Ibuprofen. Left arm very sore noticed that it was swollen and very red on Saturday. Swelling continued to get worse & redder & is still present today (Monday) & it feels itchy. Fever finally stopped Sunday evening. Every time the fever returned it took 1000 mg Ibuprofen and about 2 - 2-1/2 hours to go down and outcome of the events was not recovered. No follow-up attempts are possible; information about lot number cannot be obtained.
57 2021-03-31 lymph node swelling Lymph Node swelling left armpit Fever Chills Headache Body Aches Nausea
57 2021-04-01 lymph node swelling 29Mar2021 Approx. 5pm = slight pain at injection site (left upper arm) when I lift my arm 30Mar2021 ... Read more
29Mar2021 Approx. 5pm = slight pain at injection site (left upper arm) when I lift my arm 30Mar2021 Approx. 1pm = Nasty persistent headache with fatigue 30Mar2021 Approx. 8:30pm = Tiredness + chills. I went to bed. 31Mar2021 Approx. 11am = Felt good except for slight pain in left armpit when I move my arm. 01Apr2021 woke up at 6:30am feeling like I have a golf ball in my left armpit which look swollen compare to my right armpit (no problem here). Additionally, itching, readness on left arm skin 2 inches below vaccine injection site spreading towards my armpit. 02Apr2021 Left armpit still swollen but the golf ball feeling less prominent than the day before.
57 2021-04-02 lymph node swelling, lymph node pain Random dizziness, headache and left arm injection site slight swelling. Now under arm area/ armp... Read more
Random dizziness, headache and left arm injection site slight swelling. Now under arm area/ armpit is slightly swollen and very tender. Started taking ibuprofen for inflammation and headache
57 2021-04-02 swelling I woke up at approx. 2:30 am the next morning with my mouth (tongue and lips), eyes, and inside of ... Read more
I woke up at approx. 2:30 am the next morning with my mouth (tongue and lips), eyes, and inside of nose on fire, as if dipped in hot sauce. Anywhere I touched burned. It felt like it was coming out of my pores, and I jumped into the shower to rinse off, spreading "it" everywhere. The redness and blisters would migrate every hour or so. One minute it was my tongue, then it would show up on my chest. I called the advice nurse who instructed me to take a Benedryl. My tongue and throat were tingling. The Benedryl helped, and I was able to go back to bed but woke up four hours later worse than before. I called again and my PCP was alerted. via email. She prescribed a run of Prednisone and that stopped it, however after the run was over, it started again. A second run of Prednisone was taken. Upon completion, my throat started to tingle again, then stopped. I have pictures of the hives, swelling, and blisters on my tongue, lips, eye, and chest, I cannot take the second dose, per PCP.
57 2021-04-03 peripheral swelling Within a few hours of shot, my headache worsened significantly and got nauseous and lost appetite. F... Read more
Within a few hours of shot, my headache worsened significantly and got nauseous and lost appetite. Felt terrible and went to be early. Did not sleep well. Woke up Wed 3/31 feeling better but lightheaded/dizzy; dull headache; arm swollen /sore. Thursday 4/1 still lightheaded and more dizzy when I bent down or turned suddenly; arm still sore. Friday 4/2 morning left side of face started to feel numb/tingling , then left fingers/hand, then left toes/foot, then left calf. Checked possible stroke symptoms and no other symptoms so called Dr. NP said to go to ER since it was unilateral numbness/tingling. Admitted to ER about 11:15am and did stroke protocol to rule out stroke...got CT scan, EEG, and MRI with & without dye. All normal. Discharged about 5:45pm. Very lethargic. Sat 4/3 still lightheaded/dizzy and lethargic. Woke up about 3am early Sun (Easter 4/4) in cold sweat and nauseous; vomited; hardly slept. Feel very lethargic today and still lightheaded/dizzy.
57 2021-04-04 lymph node swelling Lymph nodes in left armpit were swollen and painful. Got better after a few days.
57 2021-04-04 lymph node swelling Lymph node swelling as large as an egg. Pain in underarm and shoulder, neck area as well as injectio... Read more
Lymph node swelling as large as an egg. Pain in underarm and shoulder, neck area as well as injection site in arm. Fever, chills, muscle aches. Started within 24 hours. Lasted more than 72 hours. Lymph node is still swollen.
57 2021-04-04 lymph node swelling Left under arm swelling and discomfort.
57 2021-04-04 swelling face Patient walked into the clinic this morning to report significant LEFT sided facial swelling. She de... Read more
Patient walked into the clinic this morning to report significant LEFT sided facial swelling. She denied any respiratory distress, difficulty swallowing or any other symptoms at that time. She states she noticed the swelling when she woke up this morning. She had not attempted any OTC medication prior to coming to the clinic. She was ordered to go to the ER for further evaluation and treatment.
57 2021-04-06 lymph node swelling soreness in arm, no feeling well, swollen lymph glands for 2-3 days following injection; bad nausea ... Read more
soreness in arm, no feeling well, swollen lymph glands for 2-3 days following injection; bad nausea and dizziness when tying to move on Day 8 - can not get out of bed due to the nausea.
57 2021-04-06 pancreatitis Pancreatitis episode, after two years with no episodes . I had 2 drinks the evening before, but do... Read more
Pancreatitis episode, after two years with no episodes . I had 2 drinks the evening before, but do not have alcoholic pancreatitis, due to gall bladder surgery
57 2021-04-08 lymph node swelling Pt. had intial sore arm soon after vaccine. She developed a large swollen supraclavicular lymph nod... Read more
Pt. had intial sore arm soon after vaccine. She developed a large swollen supraclavicular lymph node 1 day after shot. She also has headache.
57 2021-04-08 swelling, swelling Angioedema (swelling to tongue and side of neck) that started 4 days after vaccination. Swelling imp... Read more
Angioedema (swelling to tongue and side of neck) that started 4 days after vaccination. Swelling improved with steroids, epi, Benadryl and observation. Patient is on lisinopril (has been on for some time) and this is likely precipitated the event.
57 2021-04-08 swelling Face became red , burning sensation, light puffy swelling feeling 20 min after shot. Zyetac given si... Read more
Face became red , burning sensation, light puffy swelling feeling 20 min after shot. Zyetac given side effects went away. Returned 6 hrs later same symptoms benadryl given. No further issues
57 2021-04-09 swelling face my gums were slightly inflamed or puffy, particularly the upper gums; Left side of face slightly swo... Read more
my gums were slightly inflamed or puffy, particularly the upper gums; Left side of face slightly swollen/left side of face was slightly puffy; full muscular control of my face; Polyneuropathy symptoms were stirred up; Throat felt slightly itchy; Left upper forearm pain; Pain upper arm; This was a spontaneous report from a contactable consumer, the patient. A 57-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration in left arm on 06Mar2021 at 08:11 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing seasonal allergy, asthma (very mild), polyneuropathy from Aug2020 and ongoing, anxiety, and sinusitis. Patient was tested positive for Covid in Jan, she tested positive on 14Jan2021. This was a mild case and antibodies were confirmed afterwards. It was 7 weeks after she tested positive that there were confirmed positive antibodies. Concomitant medications included bupropion (MANUFACTURER UNKNOWN); gabapentin (MANUFATURER UNKNOWN), guaifenesin, pseudoephedrine hydrochloride (SUDAFED) (MANUFACTURER UNKNOWN) and Wilson's Wash (MANUFACTURER UNKNOWN). The patient previously took theophylline for asthma and experienced swelling face and pharyngeal swelling. On 06Mar2021, the patient experienced throat felt slightly itchy, left upper forearm pain, pain upper arm. On 09Mar2021, the patient experienced polyneuropathy symptoms were stirred up. On 12Mar2021, the patient experienced full muscular control of my face, at 05:30 she experienced left side of face slightly swollen/left side of face was slightly puffy. On 14Mar202, the patient experienced my gums were slightly inflamed or puffy, particularly the upper gums. It was reported that patient received the 1st dose on 06Mar2021 and Friday on 12Mar2021, when woke up, the left side of face was slightly puffy, face looked normal and had full muscular control of face, but it just went form the jaw all the way to the eyelid only on the left side. On 14Mar2021, gums were slightly inflamed or puffy, particularly the upper gums. Patient called neurologist the next day, 15Mar2021, went to see him on Thursday to have him take a look. He confirmed there was no muscular damage, but the left side of my face when poked was duller than the right side. It started 2 weeks ago today, it hasn't gotten worse and hasn't gotten better. Patient was scheduled to get 2nd dose this Sunday but going to hold off because she was concerned about this side effect. Patient tried using Claritin and Benadryl to see if that might make it go away, but it didn't. Her face does not look disfigured in any way. It's not getting worse or better. Just staying the same. She also has polyneuropathy. She got it in Aug2020 from a needle biopsy of the lymph node in her left breast. It was supposed to decrease over time over one or two years. Prior to having Covid she didn't think about it most days. When she got Covid it stirred up the symptoms. When she got the vaccine it also stirred up the polyneuropathy symptoms. She started to notice it being stirred up 09Mar2021. Her neurologist said it was her immune system working and it was aggravating it. On 12Mar2021, she had the left face thing, which was completely new, she never had symptoms like that. It has been 2 weeks and hasn't gotten worse, hasn't gotten better. She was super healthy. She doesn't drink, doesn't smoke, and exercises every day. On the needle biopsy last year by the radiologist in Aug2020. She got small fiber polyneuropathy, which causes tingling prickly sensations in different parts of the body. It was acute form and will go away in a year or two. By Jan it had minimized, but Covid stirred up the symptoms. The neurologist said any illness can cause polyneuropathy symptoms to increase. Then they started to subside. When she got the vaccine, by that Tuesday the polyneuropathy symptoms were greatly aggravated, by the 09. She was confident that they would resolve and have lessen in severity. The clinical outcomes of the left side of face slightly swollen, throat felt slightly itchy was not resolved, for the throat felt slightly itchy, left upper forearm pain was resolved on 06Mar2021, for the pain upper arm was resolved on 07Mar2021 and for event Polyneuropathy symptoms were stirred outcome was resolving. No follow-up attempts are possible. No further information was expected.
57 2021-04-10 lymph node swelling, swelling THESE SIDE EFFECTS FOLLOWED MY 4/8/21 SECOND PFIZER VACCINE: 36 hours post second Pfizer vaccine I e... Read more
THESE SIDE EFFECTS FOLLOWED MY 4/8/21 SECOND PFIZER VACCINE: 36 hours post second Pfizer vaccine I experienced debilitating full body pain; 48 hours post vaccine a 101 degree fever; 60 hours post-vaccine debilitating sharp pains in right thoracic region (difficulty drawing breath); 72 hours post-vaccine experienced swelling and tenderness in right underarm (right deltoid was site of injection); 72 hours post vaccine swelling and tenderness in neck on right side.
57 2021-04-11 lymph node swelling First dose received 4March2021, mild discomfort in right breast. Second dose received 2April2021, e... Read more
First dose received 4March2021, mild discomfort in right breast. Second dose received 2April2021, extreme discomfort in right breast. Had lymnodes removed from right arm in 2005, no cancer. Multiple breast surgeries on right breast. Right arm had two knots near the lymnode area and very painful in my breast breast after the second vaccine. Still experiencing mild pain and soreness in right breast. Scheduled mammogram on 21April.
57 2021-04-12 anaphylactic reaction 2nd dose - In addition to the flu like symptoms routinely reported I had also had anaphylaxis approx... Read more
2nd dose - In addition to the flu like symptoms routinely reported I had also had anaphylaxis approx. 24 hours after the shot. It happened between 6-11 pm on 4/12 (the day after receiving the vaccine at 6 pm on 4/11). It did not impact my breathing, but I had itchy welts and hives over most of my trunk and arms and upper legs. I took a Claritin and it helped relieve the symptoms. After the 1st dose on 3/20/2021 I also experienced mild rash like symptoms and hives for several weeks following the vaccine.
57 2021-04-12 peripheral swelling, lymph node swelling Headache-immediately lasting 4-7 days intermittently Fever-4 days Nausea (Weakness and Dizziness) M... Read more
Headache-immediately lasting 4-7 days intermittently Fever-4 days Nausea (Weakness and Dizziness) Muscle spasms and joint pain Fever -4 days Chills Fast heartbeat Cotton mouth/tightness in throat Chest tightening Tiredness Injection site pain, swelling of arm glands/nodes
57 2021-04-13 swelling Hives and swelling beginning on head and neck and then extending down the arms and body. Joint pain... Read more
Hives and swelling beginning on head and neck and then extending down the arms and body. Joint pain. Redness and swelling at injection site >10cm. Not relieved by OTC antihistamines (Zyrtec). Required prescription prednisone to resolve.
57 2021-04-14 lymph node pain, lymph node swelling Severely swollen lymph nodes in left arm pit arm of the injection also swollen lymph nodes on collar... Read more
Severely swollen lymph nodes in left arm pit arm of the injection also swollen lymph nodes on collarbone at neck. Painful to put my arm down or lift anything with my left arm, stabbing pain in lymph nodes in armpit, feels like an underwire stabbing me in the armpit Going on day three. Pain Keeps me awake at night.
57 2021-04-14 peripheral swelling MY ARM IS RED, SWOLLEN, AND VERY HOT
57 2021-04-15 peripheral swelling Symptoms first occurred approximately 26 hours after injection (4:30 pm following day). Initial sym... Read more
Symptoms first occurred approximately 26 hours after injection (4:30 pm following day). Initial symptom was mild headache progressively increasing in severity with pain between the eyes and at top of left eyeball. Pain in both shoulder joints, swollen fingers, inability to sleep, dry throat, abdominal pain in liver & spleen, pain in mouth, nausea, vomiting. Symptoms lasted approximately 14 hours until 6 am.
57 2021-04-15 swelling Early morning after second dose: severe pain in left side of neck progressing up to forehead causing... Read more
Early morning after second dose: severe pain in left side of neck progressing up to forehead causing severe headache, dry hacking cough, difficulty breathing. Saw PCP, Dr that day and was prescribed steroids to assist with breathing and cough syrup. Next day same side effects but meds helping, nervous energy. Note: had nervous energy after first dose on first few days as well. April 10, 2021, four days after second dose: phlegm building up in head and chest, coughing with little phlegm, so thick it causes choking with eyes and nose running, leading to loss of breath and almost loss of consciousness, severe headaches, continued neck pain with swelling appears to have radiated from left arm injection site, continued difficulty breathing, severe nausea and stomach cramping, body aches especially in legs, hot flashes mixed with chills (back and forth.) No fever, however. Contacted PCP. As of April 16, 2021, side effects continue with weakness in limbs, extreme lethargy and sleepiness, but restless sleep that's interupted by coughing/choking.
57 2021-04-15 swelling Initially had some pain into her left neck, then developed severe swelling with CT scan showing infl... Read more
Initially had some pain into her left neck, then developed severe swelling with CT scan showing inflammation/infection of parotid gland on ipsilateral side she received the vaccine
57 2021-04-16 lymph node swelling Violent itching, injection site side and face. Extreme eyes watering, nose running excessively. Face... Read more
Violent itching, injection site side and face. Extreme eyes watering, nose running excessively. Face beet red. BP 140/80 Sent home told to take Benadryl. Glands swollen and sore scratchy throat at home. Took Benadryl. Slept. Now 6 hours later glands swelling and extreme itchiness returning. Watery eyes
57 2021-04-16 lymph node swelling Swollen sore lymph node in left armpit and left supraclavicular lymph node
57 2021-04-16 peripheral swelling Very soon after getting the vaccine I noticed tenderness when I put on deodorant. Soon after that, ... Read more
Very soon after getting the vaccine I noticed tenderness when I put on deodorant. Soon after that, my arm began to swell and the I would feel constriction, pain when I attempted to stretch out my arm. I was having headaches, fatigue and pain. Although improving, I am continuing to have slight swelling, tenderness and pain in my left arm and hand, 2 and 1/2 months later. I am using warm compressions, ace bandage and Tylenol.
57 2021-04-16 swelling, swelling face The Left side of my face is swollen from the neck up to check bones. No treatment - no other ad... Read more
The Left side of my face is swollen from the neck up to check bones. No treatment - no other adverse effects as of yet. Just swollen face (one side)
57 2021-04-17 anaphylactic reaction anaphylaxis, requiring 3 epi pins, emergency transport, ER and inpatient treatment, 2 days hospitali... Read more
anaphylaxis, requiring 3 epi pins, emergency transport, ER and inpatient treatment, 2 days hospitalization, pcp followup.; A 57-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9266), via an unspecified route of administration, administered in Arm Left on 13Mar2021 10:00 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma and thyroid disorder. Concomitant medications included fluticasone; sodium propionate (PROPIONATE) and levothyroxine sodium. The patient previously took alatrofloxacin, pencillin, bactrim, levaquin and sulfa and experienced known allergies. The patient experienced anaphylaxis, requiring 3 epi pins, emergency transport, er and inpatient treatment, 2 days hospitalization, pcp followup on 13Mar2021 10:15. The patient was hospitalized for for 2 days on an unspecified date. Therapeutic measures were taken as a result of anaphylaxis included epinephrine, breathing treatments, speech therapy. Outcome of the event was unknown.
57 2021-04-17 lymph node swelling, lymph node pain tip of left ring finger turned white and numb/finger was completely white and the rest of her hands ... Read more
tip of left ring finger turned white and numb/finger was completely white and the rest of her hands were blue and red and white and yellow; tip of left ring finger turned white and numb; her finger felt funny; Reynauds phenomenon; sore arm; fever; chills; headache; swollen lymph node in the armpit of the arm she got her Covid 19 vaccine in; swollen lymph node started with a sharp pain and it's very sore; left foot, it was pulsing and throbbing all night; feet were modeled red, blue; feet were modeled red, blue; very sick; needed her glasses trying to give her primary care doctor's phone number; has something like gout in her foot; The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 57-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EW0150; expiry: 31Jul2021), via an unspecified route of administration in left arm on 31Mar2021 01:30 as single dose for covid-19 immunisation. The vaccination facility type was a warehouse. The vaccine was not administered at a military facility. No previous immunization with the Pfizer vaccine considered as suspect. No vaccines administered on same date with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks) and no following prior vaccinations. Medical history included covid-19 in Nov2020. The patient had no concomitant medications. The patient had the first dose of bnt162b2 on 31Mar2021 and 12 hours later (on 01Apr2021), sore arm, fever, chills and headache. Got a swollen lymph node in armpit, same arm as injection left side, today tip of left ring finger turned white and numb. She thinks it was Reynauds phenomenon. The patient called and told nurse in her doctor's office and they said if it was painful, it could be a pain clot. It was painful at first, that lymph node started 24 hours later with a sharp pain, and then she just assumed it could be a lymph node. Swollen lymph node started with a sharp pain and it was very sore. The nurse told the patient to call Pfizer. The patient was fine until the tip of her finger happened. The patient said If it was painful it could be a blood clot, would need an x ray and asked if did the shot cause this. The complete ring finger left hand, the patient looked it up and it said it could happen to her feet and she looked, and her feet were modeled red, blue it was bizarre. Never happened before. The patient was not happy about getting the vaccine, she already had covid in November of last year (2020). The patient wouldn't have called if it wasn't for her finger. Not just her feet, her hands got like this too. The patient didn't want to get the second shot. The patient asked if there was any information or mandate on timing information for the second dose, should she needed to postpone it. The patient asked if what was the efficacy after first dose as she felt like she was immune because she had the virus and now the vaccine. She was very hesitant to get the Covid 19 vaccine. She thinks her body created Covid 19 antibodies. A couple days ago she was very sick. The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows (in 2021). Even putting on deodorant she can tell it's there, it was very sore and there's a lump. Today (on 01Apr2021), she noticed the tip of her finger got white it was numb. She looked it up online and she thinks it was Reynaud's phenomenon. She has a picture if Pfizer needed it. The finger was on the same arm that she received her vaccine in. It was the ring finger on left hand. Once it started happening her finger felt funny and felt numb. She put her finger under warm water. She reported that the white color was maybe a third of the way down towards her knuckle. She was asking if this was normal or has this been reported. She had called her doctor today and spoke with the nurse who told her to call the CDC and report her symptoms. She needed her glasses trying to give her primary care doctor's phone number. The patient wanted to add that she has something like gout in her foot and on that side too, the left foot, it was pulsing and throbbing all night. She's had this pain in her left foot, she thinks its gout because it was all the symptoms of gout and she had it for a while, it hurts off and on but that night it was hurting and throbbing. She has not been diagnosed with gout in that left foot. She still has a headache but today she felt good except for her finger turning white and going numb. The lymph node in her armpit hurts. Her doctor's nurse told her if its painful to the touch it could be a blood clot so she was nervous about that. The tip of her finger was completely white and the rest of her hands were blue and red and white and yellow. She reported that her finger was back to normal now. She didn't want to get too inoculated since she also had the Covid 19 virus. The events did not require visit to emergency room nor physician office. The outcome of the events was unknown for thrombosis, Raynaud's phenomenon, erythema, cyanosis, illness, visual impairment, and gout while for the remaining events was recovering.
57 2021-04-17 oral herpes My second shot was on a Thursday, felt fine. Woke up on Friday with the typical aches, low- grade f... Read more
My second shot was on a Thursday, felt fine. Woke up on Friday with the typical aches, low- grade fever (100.9), headache, fatigue, and nausea that everyone else is describing. Did not take any Tylenol or advil. Pushed fluids and napped. Saturday I felt better but not 100 %. Rested, hydrated and took ibuprofen on Saturday evening. Sunday morning, I felt much better but noticed a sore in my left nare. I applied acyclovir cream. I can get cold sores when stressed, not sleeping or too much sun. An hour later I notice a cold sore on my upper lip, then my lower lip. Mid -morning I have 5 cold sores. Sunday evening I notice a 6th cold sore under my nose. I have been hydrating and applying acyclovir to each sore almost every hour. I am writing this report to inform you of the cold sores since I have not heard that they are an expected reaction. I did not call my doctor.
57 2021-04-17 swelling face breathing out; cheeks, lips, and mouth started quivering/trembling; cheeks, mouth and lips started q... Read more
breathing out; cheeks, lips, and mouth started quivering/trembling; cheeks, mouth and lips started quivering and twitching; swelling sensation on her left side of her face; left cheek area felt swollen and tingly; pressure around the eye sockets; Could this be a sign of Bell's Palsy, and is it likely that she develop Bell's Palsy?; This is a spontaneous report from a contactable consumer (reporting for herself). A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8734, expiry date not reported), via an unspecified route of administration, administered in left arm on 30Mar2021 14:00 at a single dose for covid-19 immunization. Medical history included has back issues, but nothing serious probably for about 7 years and patient stated that she had a Pilates injury and after that her back has never been the same; and patient stated that she was pretty healthy, adding that she was allergic to sulfa, cow's milk, wheat, and almond. Family medical history relevant to events reported included mom has osteoporosis, and severe dry eye syndrome. The patient's concomitant medications were reported as she doesn't take any regular medicines but she does take regular supplements and herbs and stated that she was very lucky. Patient stated that Pfizer COVID-19 vaccine was the he one she trusted the most and she doesn't want to die from COVID if she gets it. Patient received her dose in her left arm, at the time of administration, on 30Mar2021 14:00, she was breathing out, then her "cheeks, lips, and mouth started quivering/trembling and it was definitely noticeable". Patient further stated that while it was being administered her cheeks, mouth and lips started quivering and twitching. She also reported that immediately afterward (30Mar2021), she experienced a swelling sensation on her left side of her face, "kind of how it feels when you have novocaine, but no visible signs of swelling or drooping". Her left cheek area felt swollen and tingly. She stated that it felt swollen but it didn't look swollen, like when you go to the dentist. She also experienced pressure around the eye sockets. She added that both areas under eye sockets felt a little bit weird, tight or something but not like a pain, hard to describe. All of these symptoms resolved within a few hours, and 24 hours later she's "pretty much back to normal". The pressure around eye socket, lasted for a few hours; while trembling and quivering only happened when the shot was being administered, and 24 hours later, she was pretty much back to normal. Patient asked if this has this been reported before and if she should she get her second dose. Patient stated if this could this be a sign of Bell's Palsy, and was it likely that she develop Bell's Palsy (30Mar2021). Patient stated that all her family have all received their doses and no one had this kind of reaction. She wanted to take the second vaccine, just doesn't want to have a stroke or heart attack or anything like that. She stated that all of her events are completely gone except she still has a little bit of swollen feeling left in her cheek on a scale of 1-5 with 5 being the worst, she would say it is a 1, its pretty much gone, the swollen feeling. She stated that provider was aware of the events because she called and told her yesterday. Her family got their vaccines either moderna or Pfizer and have had no issues, other than typical ones such as forearm, a little bit of nausea, or fever but nothing like what the caller has experienced. She was the only one in her family that has had this issue. She did not have any kind of rash, no fever nausea or headache, and stated it was just like getting her flu shot. The patient did not require emergency room and physician office visit. The event swelling sensation on her left side of her face was recovering. The outcome of the other events reported was recovered on 31Mar2021.
57 2021-04-19 lymph node swelling I came off my immuno suppressant for two weeks after taking the shot to try to build up an immune re... Read more
I came off my immuno suppressant for two weeks after taking the shot to try to build up an immune response. After that, I had swollen lymph nodes in my left breast that lasted for one month and a major cardiac sarcoidosis flare that increased in intensity for eight weeks. I have now started prednisone In addition to Micophenolate 1000 mg twice a day to come the flare. One month prior to the shot, I had had a clean PT scan?no flare.
57 2021-04-19 lymph node swelling Pfizer-BioNTech COVID-19 Vaccine EUA Chills, joint pain, swollen lymph node, fever, muscle pain, nau... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Chills, joint pain, swollen lymph node, fever, muscle pain, nausea, injection site pain, tiredness, skin hypersensitive to touch and fabric and achy. Joint pain and muscle pain started within 5 hours. Most other symptoms came on about 20 hours post injection, around 11:30 am. Rested, drank liquids. Took 1 Advil at 3 pm. By 6 pm symptoms were gone - tiredness lingered.
57 2021-04-19 peripheral swelling Deep vein thrombosis was the diagnostic from the after effects of the second vaccination. Blood cot... Read more
Deep vein thrombosis was the diagnostic from the after effects of the second vaccination. Blood cot caused leg swelling and pain They did a cat scan & MRI Treatment was being given Eliquis (4 pills a day for 7 days) (2 pills after) It is a blood thinner and must follow up with my doctor.
57 2021-04-20 lymph node swelling Swollen lymph node under right are, slight tingling in right ear canal, slight tingling of exterior ... Read more
Swollen lymph node under right are, slight tingling in right ear canal, slight tingling of exterior right chin, increased hearing issues in right ear since time of vaccine.
57 2021-04-21 lymph node swelling 2nd Dose - Supraclavicular lymphadenopathy 1st Dose - 30 minutes after injection experienced ache ac... Read more
2nd Dose - Supraclavicular lymphadenopathy 1st Dose - 30 minutes after injection experienced ache across clavicle. Lasted short time, approximately 1 hour.
57 2021-04-21 swelling Started with a bump which was a little larger than a pea size. I was given the Pfizer eura at the ti... Read more
Started with a bump which was a little larger than a pea size. I was given the Pfizer eura at the time. I had no redness around the bump but was swollen and some bruzing and very sensitive to the touch with some hot sensation. Had some tingling sensation down the arm and under armpit. At this time symtons are not as they were when first given the vaccine but I do still feel some dull senstion in arm and in the shoulder area sometimes the feeling comes and goes but it's been well over a month now.
57 2021-04-22 lymph node pain Initial Shot - Swelling in the sinus' and some dizziness, exhaustion and arm pain: Lasted for day a... Read more
Initial Shot - Swelling in the sinus' and some dizziness, exhaustion and arm pain: Lasted for day and a half Second Shot - Exhaustion, Swelling in the sinus' and dizziness, Arm Pain, Pain which appeared to be in lymph nodes (under arm and side of breast), Fever x3 days: Lasted for about a week Subsequent - I have had three periods since the vaccine. I have been in menapause for 7ish years. Periods started out minor for the first one limited bleeding and 2-3 days. The second one, about a month later, was a full week of heavy bleeding. The third one came 4 days after the last one. I am currently experiencing the third one.
57 2021-04-22 lymph node swelling Swelling lymph nodes in armpit and clavicle; swelling and pain at injection site; swelling and pain ... Read more
Swelling lymph nodes in armpit and clavicle; swelling and pain at injection site; swelling and pain at injection site; a little rash in right forearm; This is a spontaneous report received from a non-contactable consumer (patient). A 57-years-old female patient received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 57-years-old, via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:30 AM (Lot Number: EW0151) as single dose for covid-19 immunisation. Medical history included Diabetes, Hypertension, Neuropathy, Radiculopathy. No allergies to medications, food, or other products. Concomitant medications included metformin hydrochloride; losartan; atorvastatin (LIPITOR); clonidine (CATAPRESS); clonazepam (KLONOPIN). Patient received first dose of BNT162b2, at the age of 57-years-old, administered in Arm Left on 03Mar2021 10:15 AM (Lot Number: EN6207) for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling lymph nodes in armpit and clavicle on 07Apr2021 21:00 with outcome of recovering, swelling and pain at injection site on 07Apr2021 21:00 with outcome of recovering, a little rash in right forearm on 07Apr2021 21:00 with outcome of recovering. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
57 2021-04-22 swelling face Big allergic reaction. Sneezing, nasal drip, face swelling and some breathing issues. Taking Loratad... Read more
Big allergic reaction. Sneezing, nasal drip, face swelling and some breathing issues. Taking Loratadine (Claritin) brought some relief to all symptoms.
57 2021-04-23 lymph node swelling Clavicular Lymph node Swelling and discomfort ongoing not resolved to date.
57 2021-04-24 anaphylactic reaction Anaphylactic reaction to second dose vaccine
57 2021-04-24 c-reactive protein increased I became extremely tired and my legs were so sore. I had a very hard time getting out of bed, puttin... Read more
I became extremely tired and my legs were so sore. I had a very hard time getting out of bed, putting my shoes and socks on and bending over. It is so painful that i shake when I bend over. I have also had a headache on and off since then. I called the CDC, Health Dept, amd my doctor and was told that was normal. When I went for my secoond shot the nurse who administered the shot said it was my lymph nodes. I went to my doctor who ordered some bloodwork. My SED Rate West was 38, CRP Extended range was 59.62 and my RBC was 4.15. These are not typos! These were completed on March 11, 2021.
57 2021-04-24 peripheral swelling Joint pain; swollen hand, can't close hand, can't grip; swollen hand, can't close hand, can't grip; ... Read more
Joint pain; swollen hand, can't close hand, can't grip; swollen hand, can't close hand, can't grip; Slightly swollen middle finger; This is a spontaneous report from a contactable consumer (Patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) dose 1 via an unspecified route of administration, administered in Arm Left on 10Apr2021 12:30 as single dose for covid-19 immunisation. Medical history included Type 2 Diabetes and high cholesterol. Concomitant medication(s) included Metformin, Atorvastatin and Vitamin D. The patient experienced joint pain, swollen hand, can't close right hand, can't grip. Patient did not have covid prior vaccination and not tested for covid post vaccination. Patient did not have known allergies. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
57 2021-04-24 peripheral swelling Swelling at the injection site; Her arm was the size of an egg and it was hard; A significant drop i... Read more
Swelling at the injection site; Her arm was the size of an egg and it was hard; A significant drop in her platelet level; She was tired for 24 hours; This is a spontaneous report received from a contactable consumer (patient) and via a Pfizer-Sponsored program. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 25Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 27Mar2021 the patient experienced a significant drop in her platelet level and on unspecified dates the patient experienced swelling at the injection site, her arm was the size of an egg and it was hard and she was tired for 24 hours. The patient stated that she received the first dose of the Pfizer COVID-19 vaccine on 25Mar2021 and she then had routine blood work done on 27Mar2021 (also reported as 29Mar2021) which showed a significant drop in her platelet level. She stated that she normally had a platelet count on the lower side, but the platelets were quite a bit lower than the last bloodwork she had done. She stated that she had blood work last on 24Mar2021 which is why she knew. She stated that her platelets dropped after she got the first dose. She checked the internet for side effects of the vaccine and she did see that some people had reported that a lowered platelet count could happen. She stated that she was doing research to investigate if this was truly a side effect of the vaccine. She wanted to know if this had been reported before. She would like to know before she got the second vaccine. The patient also stated that she also had swelling at the injection site, her arm was the size of an egg and it was hard, and she was tired for 24 hours. The patient wanted to know if she would still need to wear a mask after having received both doses if she decided to go out in public or visit others and she wanted to know how effective the first dose was if she decided not to receive the second dose. The clinical outcomes of the events a significant drop in her platelet level, swelling at the injection site, her arm was the size of an egg and it was hard and she was tired for 24 hours were all unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
57 2021-04-25 lymph node swelling Swollen lymph gland under arm of shot.
57 2021-04-26 c-reactive protein increased, swelling face On April 1st lost all eye sight in right eye for a few minutes and wet feeling in right quad all da... Read more
On April 1st lost all eye sight in right eye for a few minutes and wet feeling in right quad all day (thought my leg was wet all day but wasn't). On April 2 woke up to stabbing pains in eye and couldn't see in right eye. Went to (Regular doc) that afternoon (Vision in left eye 20/25, right eye 20/70)she referred me to Opthamologist right then. Opthamologist diagnosed me with Optic Neuritis in right eye (50% loss of brightness and color). Referred to Neurologist, hands and legs going numb, bad vertigo. Neurologist ordered 3 MRIs with and without contrast (Brain, Thoracic spine and cervical spine). All clear. Numbness, vertigo continues. On April 18th woke up with swollen/red cheeks and fluid build up under both eyes.. same place a where filler was injected into face. On April 19, did a wide range of blood work...all normal except CRP was 25.1. Gave me penicillian and steroid shot, and 7 day steroid pack. Vertigo and numbness continued. On April 27th symptoms seem to be a better but everyday this moves around my body with different symptoms like one day my left hand is numb and the next it's my right hand. Eyesight still not normal. Vision in right eye is blurry, compared to left.
57 2021-04-29 bursitis Site: Pain at Injection Site-Medium, Additional Details: patients arm still hurts. it might have bee... Read more
Site: Pain at Injection Site-Medium, Additional Details: patients arm still hurts. it might have been given up too high causing bursitis.
57 2021-04-29 peripheral swelling Huge swelling of left breast and under arm, remaining seroma from left breast became abscessed and w... Read more
Huge swelling of left breast and under arm, remaining seroma from left breast became abscessed and was I & D'd with approximately 1/4 cup of green pus. Wound left open to continue draining. Given 1 Gram of Rocephin and 7 days of Bactrim. After 5 days, saw original surgeon who advised packing with 1/4 inch packing material in hopes of seroma healing inside out. Also had major body aches, severe headache 102.5 fever, etc. for 24 hours.
57 2021-04-29 swelling face Facial fillers have ballooned up, cheeks and lip really swollen and red
57 2021-04-29 swelling I had my first dose of the Pfizer COVID-19 vaccine on Tuesday, April 27, 2021. On Wednesday morning... Read more
I had my first dose of the Pfizer COVID-19 vaccine on Tuesday, April 27, 2021. On Wednesday morning, April 28th, I noticed that my knees we swollen. As the day progressed, I became tired and vacillated between being chilled and hot. I did not have any other symptoms. On Thursday, April 29th, I noticed that my clothes were fitting very snug. It appears that the COVID-19 vaccine has caused my body to become swollen. To test this theory, I put on a pair of pants that I wore on Monday, April 26, 2021, which were baggy. And the same pants are tight. I am scheduled for my second dose of the COVID-19 vaccine on May 18, 2021.
57 2021-04-30 lymph node swelling Sharp pain and aching over entire body, weakness, all joints in pain, headache, swollen lymph node b... Read more
Sharp pain and aching over entire body, weakness, all joints in pain, headache, swollen lymph node by left jaw
57 2021-04-30 peripheral swelling Vein protruding, extreme arm pain and swelling, high fever, sensitivity to touch
57 2021-04-30 peripheral swelling her left arm that is swollen; This is a spontaneous report from a contactable consumer. A 57-years-o... Read more
her left arm that is swollen; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 03Apr2021 11:00 as SINGLE DOSE (at the age of 57-years) in Arm Left for covid-19 immunization. The patient had no relevant medical history. The patient did not receive any prior vaccinations (within 4 weeks). The patient's concomitant medications were not reported. On 03Apr2021 at 12:00, the patient's left arm was swollen after her first shot. She reported that her left arm that is swollen, the arm she got the shot in. It was still swollen and worsened. She enquired whether she should go to the hospital. The patient did not receive any treatment. The outcome of event was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
57 2021-04-30 peripheral swelling Genital swelling; hand swelling; Feet swelling; Chills; Headache; This is a spontaneous report from ... Read more
Genital swelling; hand swelling; Feet swelling; Chills; Headache; This is a spontaneous report from a contactable consumer (patient, self-reported). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7533 and expiration date was not reported), via an unspecified route of administration on 30Mar2021 14:50, as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6208), via an unspecified route of administration on 09Mar2021, as single dose for COVID-19 immunization and experienced same event (chills, headache, swollen hands, feet and genital). It reported that on 31Mar2021 patient experienced chills and headaches that went away after a day. And next day on 01Apr2021 experienced Feet swelling and on 05Apr2021, hand and genital swelling. Patient mentioned that the swelling on her hands and feet went away but her genitals are still a little swollen. She mentioned that genital swelling gets a little less day by day. She will be seeing her doctor and would like to know what to tell him before getting treatment. Caller stated the first day she took Tylenol for her headache just one Tylenol and it went away. Caller stated she had all these symptoms after the first dose as well. Adverse events does not require a visit to emergency room and no physician office. No prior vaccinations within 4 weeks and no adverse event following prior vaccinations. The outcome of the event chills and headache were recovered on 01Apr2021, feet swelling was recovered on 02Apr2021 and hand swelling was recovered on 06Apr2021 and the outcome of the event genital swelling was recovering. Follow-up (15Apr2021): This is a spontaneous report from a contactable consumer. Patient demographic, event details, corrective treatment information's were updated and Caller stated she had all these symptoms after the first dose as well. No follow-up attempts are needed. No further information is expected.
57 2021-04-30 swelling face She had problems with her heart; lot of stress; Swelling and redness of face; Swelling and redness o... Read more
She had problems with her heart; lot of stress; Swelling and redness of face; Swelling and redness of face; Triglycerides over 400; Severe vertigo; Blood pressure went high/blood pressure went up to 185/115; 150/95/; Fell; Ocular migraine; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 03Apr2021 08:00 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure. It started about 20 years ago. It was from stress. Family Medical History included her father had kidney disease, but she did not have any problems with her kidneys. She had a blood test and it was fine. The patient's concomitant medication included usual blood pressure medication. Patient went and had the first shot of the Pfizer Covid-19 Vaccine on 03Apr2021 (also reported as 04Apr2021), and she did okay on it until the following Friday (09Apr2021), 6 days later. She actually had to call her daughter to get her from work. She was suffering from severe vertigo, her blood pressure went high, she fell, and she had ocular migraine on 09Apr2021. Her blood pressure went up to 185/115 which was tested on 12Apr2021. She had problems with her heart at the time (unknown date). She broke out and had swelling of her face and redness on 13Apr2021. She went to the doctor and he had her on steroids. This was with the first dose. She was concerned about the second shot. She was due to do it again in about a week, and she was still not over the one. She had been out of work the whole time. Her blood pressure was still kind of high because she did suffer from volatile blood pressure with stress on her body. Her blood pressure would fluctuate, but it had never been that high. It happened when her body was under a lot of stress. It was still high, but not as high. It was about 150/95. That was normal for her. It was like bam, it all hit her hard. Triglycerides over 400 on 12Apr2021. The migraine had gotten better. It's gone. Her migraine was completely gone. As far as the problems with her heart, her blood pressure was fluctuating and would go up and all of a sudden drop. It was not often, it did it when she was under a lot of stress. She just didn't know if the shot had put her body under stress. The swelling and redness on her face was still there. Outcome of severe vertigo, blood pressure went high was resolving. Outcome of fall, problems with her heart and stress was unknown. Outcome of ocular migraine was recovered on 09Apr2021. Outcome of swelling and redness of face was not recovered. No Follow-up attempts are needed. No further information expected.
57 2021-04-30 swelling, lymph node swelling swollen submandibular lymph nodes; swelling/swelling went to the back, the shoulder blade up the lef... Read more
swollen submandibular lymph nodes; swelling/swelling went to the back, the shoulder blade up the left side of her neck; swelling/swelling went to the back, the shoulder blade up the left side of her neck; redness; pain started at injection site; pain went from her elbow to shoulder and then up her shoulder and up to the neck; pain went from her elbow to shoulder and then up her shoulder and up to the neck/she still has arthritic type pain in left arm socket.; couldn't lift her left arm at all; deep ache/ to her back; crying; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 12Apr2021 at 16:30 (lot number reported as "EN or W 0161, EN0161 or EW0161") at a single dose for COVID-19 immunisation. Medical history included diabetic from 2008, blood clots , COVID-19 (reported as April; year unknown), insulin dependent in 2014 , Protein S deficiency, genetic disorder that makes her have blood clots, neuropathy. Concomitant medications included warfarin sodium (COUMADIN) taken for Protein S deficiency, genetic disorder that makes her have blood clots from 2007 to an unspecified stop date; gabapentin taken for neuropathy from Sep2019. Patient stated that she gets a mild case of the flu when she gets the flu vaccine, but she doesn't remember back to childhood. She got an MMR booster about 20 years ago and had no problems then. Family Medical History: both parents had diabetes; mother has Protein S deficiency as well that causes blood clots. The vaccine was administered at healthcare facility. The patient did receive previous immunization with a Pfizer vaccine. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient received her first shot on Monday 12Apr2021 and was fine until 12 hours later. Her arm swelled up and she couldn't lift it. Then the swelling went to the back, the shoulder blade up the left side of her neck. She could feel her lymph nodes and so she was icing it, taking Tylenol and the swelling has gone down. The redness was gone but she still has arthritic type pain in left arm socket. She can lift and move the left arm, but it hurts, and it also hurts when she turns her head to the right. She received the Pfizer COVID vaccine in her left arm. The pain started at injection site and then went from her elbow to shoulder and then up her shoulder and up to the neck. Her family was commenting on her neck being swollen. She received her shot at 4:30 PM on 12Apr2021. The redness and swelling started at around 5:00 AM on 13Apr2021. A couple hours after Pfizer COVID vaccine injection the pain started. She waited for 30 minutes because she takes coumadin for a history of blood clots, nurse wanted to wait to make sure her arm wouldn't bleed. She has been taking Benadryl ointment and icing it for 3 days as treatment for the events. She got up at two this morning to go to the bathroom and noticed she could still feel the pain when she turns her head to the right. She had swollen submandibular lymph nodes and could feel two of them before. When she woke up, she could not feel her lymph nodes. Everything has recovered except for the pain. The patient stated that on the first day the symptoms were disabling, and she couldn't lift her left arm at all. They got better once she started icing it and rested instead of doing chores. She keeps popping Tylenol every 6 hours, Benadryl and refilling ice bag with one ice bag on neck and one ice bag on arm. There was a deep ache right now in the socket that goes up her neck and down the shoulder blade to her back. Right now, she doesn't like to be in any pain and would say the pain was mild compared to how it was, the pain was so bad she was rocking and crying. Her brother gave her one of her mother's pain pills, one Vicodin because she was in so much pain. She can control the pain now with the extra strength Tylenol. She got the Pfizer COVID vaccine for lots of reasons. She has a lot of health problems, she had COVID virus last April and that was why she was having this reaction since she already has antibodies. She takes care of her mother who was sicker than she was. She was out in the real world and she doesn't want to bring anything home or get anything herself. She thought gabapentin would have made it to where she did not have the arthritic pain from vaccine. She takes gabapentin for neuropathy. She was diabetic and that may have something to do with it too. Patient stated that everyone else in her family got Johnson and Johnson and nobody had reactions. She was supposed to get at the Johnson and Johnson shot first but with the shortage it was switched over the to Pfizer COVID vaccine. This was her first dose of the Pfizer COVID vaccine. Redness and swelling started at around 5:00 AM 13Apr2021. Pain started around 6:30 PM. The events did not require emergency room visit or hospitalization. She was at the urgent care yesterday where she gets her INR checked and the nurse said she didn't see any swelling but believed she was in pain because the she didn't want to lift the left arm. The reporter assessed the events swelling, redness, and pain were considered serious (disabling). Outcome of the events vaccination site pain, neck pain, arthralgia, and back pain was recovering, for event crying was unknown, for event swollen submandibular lymph nodes was recovered on unspecified date, while for events swelling, joint swelling and redness was recovered on 16Apr2021. Information on the lot/batch number has been requested.dft; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate
57 2021-04-30 swelling headache; nausea; light headed/ dizziness; unsteady gait; vomiting; chills; sweats; superficial bloo... Read more
headache; nausea; light headed/ dizziness; unsteady gait; vomiting; chills; sweats; superficial blood clot; pain to back of Rt knee; bruising; swelling; This is a spontaneous report from a contactable Nurse. A 57-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, administered in Arm right on 31Mar2021 (Batch/Lot Number: EW0150) (at age of 57-year-old) as single dose for COVID-19 immunisation. Medical history included osteoarthritis, and migraines. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2, intramuscularly, administered in left Arm on 10Mar2021 (at age of 57-year-old) (Lot number: EN6207) for COVID-19 immunisation. It was unknown if other vaccine in four weeks. It was unknown if COVID prior vaccination. The patient experienced onset of pain to back of Rt knee, bruising, and swelling on 06Apr2021. She called doctor on 09Apr2021, provider diagnosed her with superficial blood clot. Treating with applying warm compress to area. Client had onset of headache, dizziness, nausea, light headed, unsteady gait, vomiting, chills and sweats on 10Apr2021. Patient called doctor on 14Apr2021, they recommended covid-19 testing, results are negative on 12Apr2021. Symptoms ongoing since 14Apr2021. The outcome of events was not resolved.; Sender's Comments: Based on plausible temporal association, a causal association between the reported event thrombosis and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
57 2021-05-01 lymph node pain, swelling My lips are numb. My left side is swollen and numb. There's a little soreness in my left arm, but... Read more
My lips are numb. My left side is swollen and numb. There's a little soreness in my left arm, but very sore in my left armpit (lymnodes) My skin feels itching today. I felt a burning sensation and numbness last night.
57 2021-05-02 peripheral swelling The day after she noted a burning pain in thighs her down both legs and her back and also involves b... Read more
The day after she noted a burning pain in thighs her down both legs and her back and also involves both her forearms. Any movement, especially walking causes more pain in there legs and back. It is difficult for her to separate whether this is in the muscles or joints. The pain has been getting worse and over the last few days she has noted swelling of her LLE and says that she can't put her shoe on. Despite the swelling on the L, she says the R leg hurts more.
57 2021-05-03 lymph node swelling Nausea, fatigue, body aches, swollen lymph nodes in right arm pit
57 2021-05-05 c-reactive protein increased Patient received vaccination midday on 4/30, had mild generalized myalgias on 5/1, by evening of 5/2... Read more
Patient received vaccination midday on 4/30, had mild generalized myalgias on 5/1, by evening of 5/2 had generalized weakness of all extremities causing her to be unable to ambulate was found down on the floor. Admitted to the hospital on 5/1 and transferred to our medical center on 5/2 with persistent weakness. Physical exam concerning for possible transverse myelitis versus myositis versus vaccine reaction with 4/5 strength in all 4 extremities
57 2021-05-06 anaphylactic shock anaphylactic shock; I started to pass out; tingle in her lip/her tongue was tingling; her BP was 150... Read more
anaphylactic shock; I started to pass out; tingle in her lip/her tongue was tingling; her BP was 150 something over 90 she thinks she heard 159 before they gave her; her throat is starting to close up; trouble swallowing; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 17Apr2021 at 14:45 (Batch/Lot Number: EW0162), at the age of 57 year, as single dose for COVID-19 immunization. Medical history included anaphylactic reaction to spider bites, pruritus, ongoing hypersensitivity, ongoing allergy to arthropod sting. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Lortab [hydrocodone bitartrate;paracetamol] and experienced drug hypersensitivity, singulair and experienced drug hypersensitivity. Concomitant medication included neocell super collagen, 6g collagen six per day as supplement. On 17Apr2021 the patient experienced anaphylactic shock, reported as medically significant. The patient reported "I started to pass out. She had tingle in her lip/her tongue was tingling. Her BP was 150 something over 90 she thinks she heard 159 before they gave her; her throat was starting to close up, she had trouble swallowing. She went to the hospital straight from the clinic where she received the vaccine. The patient reported the following: she went for shot at 14:30 and they didn't take her in until like 14:45. Patient stated after the shot, she sat down and knew she had to wait for at least 30 minutes because 10 years ago she had a couple events of anaphylactic shock due to spider bites. So patient stated she knew she should wait. Patient stated she started reading her book and had trouble swallowing at 5 minutes later, but she decided to keep reading book. Patient stated that 10 minutes she started to feel a tingle in her lip and then she started paying attention. Patient stated she then went over to the staff and found someone who was not busy and explained to them what was happening. Patient stated that staff member walked her over to the nurses station and at that time her tongue was tingling and this is not even 15 minutes later. The patient stated they gave her 10 ml of Benadryl and at about 15:05 at about 15:20 they had to give her the epinephrine because her throat was starting to close up and they called 911. The patient stated unfortunately the epi didn't; it may have slowed it down but she started to pass out. She don't know what her oxygen level was at that point. The patient recalled that her BP was 150 something over 90, she thinks she heard 159 before they gave her the Benadryl or at the same time. The patient stated once the EMT's showed up they gave her an IV and gave her steroids and that stopped her throat from closing and they gave her oxygen and that made her feel so much better. The patient stated it's like reliving the story here and her throat is starting to close up, patient clarified she is just choking up thinking about it and denied that her throat is actually closing up during call. The patient stated they did a lot of testing after did not show any signs of clotting which was good. Patient stated she did have trouble breathing, and they checked heart and her heart was fine. Patient states her throat, that is the part she needs to talk with her doctor about. Her throat didn't start to completely relax. Patient stated it was still tight on Sunday and Monday and that was a little concerning for her, but as far as lab work, no. Patient stated she was not admitted to the hospital, she spent 5 hours in the emergency room (ER) for observation and got sent home with an epi pen which she is not going to get and steroids which she finished yesterday. Patient stated she is not going to get the EpiPen because she does not foresee any need for it due to the amount of money it costs. Patient stated it costs $232 dollars and that is just too much, not to mention the amount of money she will have to give to hospital for the bill due to this event. Patient stated she is pretty clear that she won't or shouldn't get the next shot. The clinical outcome of Anaphylactic shock was recovered on 20Apr2021. The clinical outcome of her throat is starting to close up was not recovered. The clinical outcome of the remaining events was unknown.
57 2021-05-08 swelling Broke out in hives seven days after my first shot, waited about a week to see if they would go away,... Read more
Broke out in hives seven days after my first shot, waited about a week to see if they would go away, treated with Prednisone and Zyrtec, no change, they got worse. A week or so later went to an allergist a couple of days before my second shot who assured me it wasn't from the vaccine, prescribed Triamcinolone Acetonide which helped with the swelling but kept getting outbreaks, went to my dermatologist about 1 and 1/2 weeks later who took a biopsy and said the biopsy showed a "drug" reaction. Told me to wait it out another month until it got through my system. That was 3 days ago and I'm still breaking out.
57 2021-05-08 systemic inflammatory response syndrome, sepsis Severe joint pain, fevers, severe headaches, cough, severe fatigue, the first week. Second & 3rd wee... Read more
Severe joint pain, fevers, severe headaches, cough, severe fatigue, the first week. Second & 3rd week -Positive D dimer,low o2 sat.s. high fevers and body/joint pain. 4-6 week-Hemoptysis, Systemic inflammattory response syndrome, sepsis, acute bronchitis, uveitis and vertigo. Info below is for answer 21 1 admissions to Hospital was 4 days 2nd admission to Another Hospital. 6 day stay Most of the treatment was antibiotics, oral steroids, steroid drops for my eyes and breathing treatments to open my airway.
57 2021-05-09 swelling Date and time adverse event started: 1st dose 2-3 days post-vac at unk time. 2nd dose 4/30/2021 imme... Read more
Date and time adverse event started: 1st dose 2-3 days post-vac at unk time. 2nd dose 4/30/2021 immediately after injection. Date and time of vaccination: (list both if they received both shots): 1st dose 4/9/2021 ~1100. 2nd dose 4/30/2021 ~1300. Brand and lot of vaccine: Pfizer 1st dose LOT#: E(E/U)50151. 2nd dose LOT#: EW0171 . Caller reports that with 1st dose her mother felt very tired, and she was achy and had pain all over her body for couple of days. 2nd dose, caller reports her mother had immediate pain during injection (pt felt like the the person who gave her the shot injected too high up on her left arm) bc she felt instant pain. 5/1/2021 pt cannot move her left arm, her neck is swollen (does not hurt when touched or swallow) and there's pain to the left side of her neck when she turns her head to the right. What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these): 1st dose pt took Tylenol, this helped per symptoms went away on the 4th day post-vac. 2nd vaccine, pt have not tried anything. Ever have a reaction to a previous vaccine? If yes, what? None. ***NOTE*** Recommend caller the pt can take Tylenol or Ibuprofen to see if that will help with the pain; also recommend to stay hydrated. Advised the swelling in her neck may take up to 10 days to resolve. Recommend if her symptoms does not get better in a couple of days to take her to hospital to be evaluated since pt does not have health insurance. 5/5-Patient has taken Tylenol to alleviate symptoms, swelling in the neck has decreased, minimal pain as of now. Reports feeling much better.
57 2021-05-10 anaphylactic reaction Presented to the emergency room 5/3/21 after the development of multiple symptoms after her second C... Read more
Presented to the emergency room 5/3/21 after the development of multiple symptoms after her second COVID vaccine on Friday. Symptoms consisted of perioral tingling, some possible oral swelling, and then subsequent shortness of breath with labored breathing. Initial treatments in the emergency room did result in some symptomatic benefit, however, the patient continued to have an oxygen requirement and demonstrated persistent symptoms of anaphylaxis. She was then admitted to the intensive care unit for higher level intervention.
57 2021-05-10 axillary mass Fever for two days; injection site pain - for two days. Body pain for about three days. Then after t... Read more
Fever for two days; injection site pain - for two days. Body pain for about three days. Then after those I got COVID symptoms and was tested positive. After I had COVID - I had axilla lump pain; cough; fever; upper respiratory cough; body aches for about 10 days; I was off of work for about two weeks. I had to go through the Medical group through my doctor and was given a bronchial dilator prescription and that helped clear up the symptoms. I still have discomfort in my lymph nodes - under my arms.
57 2021-05-10 lymph node swelling Swollen cervical/neck lymph node glands - left & right (Has not yet subsided) Stiffness, achiness in... Read more
Swollen cervical/neck lymph node glands - left & right (Has not yet subsided) Stiffness, achiness in neck & upper back Fever, chills, body aches, dizziness, nausea Soreness & itchiness & lump/swelling at vaccine sight - left arm
57 2021-05-10 lymph node swelling Injection site turned red, hard and swelled up; Injection site turned red, hard and swelled up; My a... Read more
Injection site turned red, hard and swelled up; Injection site turned red, hard and swelled up; My axilla and peck muscle was swollen to 3 times it's size; feel a big swollen node; Flu type symptoms; This is a spontaneous report from a contactable other-HCP (Patient). A 57-year-old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269), via unspecified route of administration, administered in left arm on 04Feb2021 at 09:30 AM (at the age of 57-years) as single dose for COVID-19 immunisation. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3249), administered at left arm on 12Jan2021 at 09:45 AM as single dose for COVID-19 immunisation. The patient medical history included osteoarthritis. Patient had no known allergies. Concomitant medications included levothyroxine and acyclovir. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 05Feb2021 at 11:30 AM (26-hours after vaccination), patient experienced flu type symptoms and at 09:30 PM (36-hours after vaccine), injection site turned red, hard and swelled up. On 06Feb2021 (morning), axilla and peck muscle swollen to 3 times its size. Patient received ibuprofen and Benadryl for treatment, and it went down a little however, patient can still feel a big swollen node that appeared a day before. No specific treatment was given for swollen node. Since the vaccination, patient was not tested for COVID-19. The outcome of all the events was not recovered.
57 2021-05-10 swelling, lymph node swelling Pain in neck, ear, and really bad headache in the base of the skull. Left arm aches and sometimes f... Read more
Pain in neck, ear, and really bad headache in the base of the skull. Left arm aches and sometimes feels numb and heavy. Sharp head pain in spot by ear. Shoulder hurts but does not hurt to move in any direction. No pain where the injection site is. Thought I was having a stroke of some kind. Didn't happen right after shot but a few days later. Swelling on side of neck and hurts to touch. Lymph nodes seems to hurt under clavicle
57 2021-05-11 swelling face About 18 hours after the vaccination, I noticed itching on the back of the head, then welts, then t... Read more
About 18 hours after the vaccination, I noticed itching on the back of the head, then welts, then terrible buttocks itching and welts. 20 hours later one droopy eye. 32 hours later swollen shut eyes , lips and checks swollen. Back and buttocks were red and extremely itchy! Was treated with Anthistamine at Emergency Room. 4 days later I was recovered with steroids!
57 2021-05-12 swelling face pt had allergic reaction. migraines, swelling of lips and face, itchiness all over body started 5/... Read more
pt had allergic reaction. migraines, swelling of lips and face, itchiness all over body started 5/11/2021- still occurring today 5/13/2021
57 2021-05-13 lymph node swelling (thinking it's swollen neck lymph nodes); sore neck; Shingles; upper torso skin HURTS; This is a spo... Read more
(thinking it's swollen neck lymph nodes); sore neck; Shingles; upper torso skin HURTS; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in arm left on 27Apr2021 at 09:15 (at the age of 57-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included psoriasis, migraine and known allergies to some medications from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: EW0150), on 06Apr2021 at 14:00 for COVID-19 immunisation and experienced sore arm. The day the patient received the second dose, she felt fine. Woke up on the 2nd day (28Apr2021 04:30) to sore neck (thinking it was swollen neck lymph nodes) and upper torso skin hurts (she feels like it's the shingles again). Two (2) ibuprofen (MOTRIN) has helped, but the MOTRIN is wearing off. Therapeutic measures were taken as a result of neck pain and skin pain; no treatment received for other events. The outcome of the events was recovering.
57 2021-05-13 swelling, peripheral swelling Approximately 3 days after I received this second COVID vaccine, all the joints in my body (neck, sh... Read more
Approximately 3 days after I received this second COVID vaccine, all the joints in my body (neck, shoulders, elbows, wrists, fingers, hips, knees, ankles, and toes) experienced swelling and significant pain. The worst was the left arm where I had received the second vaccine shot. Despite Prednisone tapers and NSAIDS, the pain and swelling continue, particularly on the left arm side. I cannot even straighten three of my left hand fingers and cannot make a tight fist to this day. If the vaccine did not cause this directly, then it triggered a significant Sjogren's flare that has not been alleviated with the usual medications that have worked in the past with joint pain. This is worse than any flares I have had previously. I already submitted an adverse report about the sudden abscessing of my right breast cyst that had been sitting there for decades after the first COVID shot. I believe these events are related to the vaccine.
57 2021-05-15 peripheral swelling 1 st shot: Swelling in arm/Pain, headache. Tired, Muscle aches. lasted 2 days. (No Fever). 2 nd shot... Read more
1 st shot: Swelling in arm/Pain, headache. Tired, Muscle aches. lasted 2 days. (No Fever). 2 nd shot: Swelling in arm/Pain, Extreme Headache, Fever 101.5, Extreme muscle aches, nausea, vomiting. These symptoms lasted 2 days.
57 2021-05-15 peripheral swelling In addition to just usual arm pain and tired on day on vaccine #1 12/23/2020; after 24 hrs had sudde... Read more
In addition to just usual arm pain and tired on day on vaccine #1 12/23/2020; after 24 hrs had sudden onset extreme weakness, brain foggy, anorexia, extreme sleepiness, my weakness prevented me to continue typing my notes using my hand and walking out of room, made me immediately turn back to rest. Took 20mg prednisone and slept. Symptoms resolved after 2 hrs of sleep in chair in office. Next day took usual dose 2mg back. Doing ok but then after few days (Lee?s than a week) had paresthesia like (burning needle pin) migratory on different parts of upper and lower extremity. No motor weakness. This has gone on even after 2nd vaccine. 1/13/2021. It got better in February but then came back in April with increased frequency and intensity with small blisters on firearms both sides where burning sensations felt. Now it also made me feel weak, sleepy, hands and feet Paine with mild spindle like puffiness of fingers with pain on pip more than mcp. Had to increase prednisone 10mg a day and felt tolerable but wheN go below 5mg, the pain of hand and feet and frequency of dysesthesis and blister was not well tolerated to do my routine work
57 2021-05-16 herpes virus infection Client states she developed a generalized rash (hands, wrists, knees, stomach, groin, neck, face) on... Read more
Client states she developed a generalized rash (hands, wrists, knees, stomach, groin, neck, face) on the 7th day after her first dose of the Pfizer vaccine - itchy/some of the rash blistered - saw an MD who diagnosed it as a herpes infection - saw her usual provider who diagnosed it as an allergic reaction rash - prescribed antibiotics and prednisone - some of the rash remains and is itchy but no longer blistered.
57 2021-05-16 lymph node swelling supraclavicular swelling and discomfort
57 2021-05-16 swelling Swollen and painful left side of neck by shoulder blade. Symptoms noticed on May 15 with swelling, r... Read more
Swollen and painful left side of neck by shoulder blade. Symptoms noticed on May 15 with swelling, redness and pain. Swelling and nodule size of a lemon. Today still hurts with nodule about size of a quarter. Feels warm when touched.
57 2021-05-17 peripheral swelling I experienced sever pain to my left arm with swelling. The pain radiated from, my left arm to my nec... Read more
I experienced sever pain to my left arm with swelling. The pain radiated from, my left arm to my neck, head and all the way down to my fingertips. I also had numbness sensation. I tool Tylenol for pain and an anti-inflammatory medication. I did continue to have unexplained muscle spasm and fatigue. I went to see my PCP to evaluate my fatigue and muscle spasm that has not resolved.
57 2021-05-18 swelling face Numbness; Swelling occurred in the area between my mouth and chin on the left side of my face; When ... Read more
Numbness; Swelling occurred in the area between my mouth and chin on the left side of my face; When touching the area there is a lump that measures between an inch and two; Speech is weird; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration on 03Mar2021 04:00 PM in the left arm at 2nd dose, single for COVID-19 immunisation. The patient age at vaccination was 57 Years. Medical history included IBS (inflammatory bowel disease) and recently the patient was developed a sensitivity to shrimp that results in hives. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Batch/Lot number: EL9282) received in left arm on 10Feb2021 05:00 PM for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine and not received other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 Prior to vaccination and after the vaccination. On 05Mar2021 7:15 AM, the patient had swelling occurred in the area between my mouth and chin on the left side of my face up and my speech is weird. It almost feels like I went to the dentist and got a shot of novocaine in that area. When touching the area there is a lump that measures between an inch and two. I took two Benadryl at 7:35 or so and the swelling has started to decrease but is still there, as well as the numbness. Therapeutic measures were taken as a result of numbness (hypoaesthesia), swelling occurred in the area between my mouth and chin on the left side of my face (swelling face), when touching the area there is a lump that measures between an inch and two (mass) with Benadryl and novocaine. The patient reported that she do not know if this was happened before but potentially having a reaction to the vaccine that she got on Wednesday part of face has swelled up. Outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
57 2021-05-19 peripheral swelling Heart palpitations body shaking lost of weight headache. Went to the emergency room on 4/19/2001 I w... Read more
Heart palpitations body shaking lost of weight headache. Went to the emergency room on 4/19/2001 I was the diagnosed with Graves disease I am now on medication. I now have suffered with burning and swelling in my arms and hands I am back in the hospital. I have been very sick since vaccine was administered
57 2021-05-20 lymph node swelling 5/15/2021, 10:45 am-Twinge in left side of neck muscle; 1:30 pm-mild headache, lower back pain left ... Read more
5/15/2021, 10:45 am-Twinge in left side of neck muscle; 1:30 pm-mild headache, lower back pain left side only; 3:30 pm-plantar fasciitis pain left foot only; 5:39 pm- mild body aches left side only; overnight during sleep-moderate body aches entire body. 5/16/2021- woke up with severe headache, moderate body aches whole body, mild chills whole body; plantar fasciitis pain left foot only continued; 1:30 pm-fever 100.2; mild to moderate nausea througout rest of day;these symptoms continued for about 24 hours. 5/17/2021- previous days symptoms subsided late morning; 11:00 am-feel like left collar bruised; 4:00 pm-discover lump left side of neck above collar bone. 5/18/2021-Wake up with moderate headache and nausea which supplies by late morning. Lamp on left side of neck by collarbone still there. 5/19/2021-lump on left side of neck still there; pain underneath left arm,. 5/20/2021-lump on left side of neck still there; pain underneath left arm, tweaking pain inside left thigh, left armpit near lymph node occasional pain and tender. 5/22/2021-woke up to severe headache and nausea which subsided by noontime. L ump on left side of neck still there.
57 2021-05-21 swelling face, anaphylactic reaction Anaphylactic reaction; increased heart rate; painful; Face was bright red and puffy; Face was bright... Read more
Anaphylactic reaction; increased heart rate; painful; Face was bright red and puffy; Face was bright red and puffy; I couldn't breath; Rash on left arm; Dizzy; injection site enlarged and swollen like 5 inches; injection site enlarged and swollen like 5 inches; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the arm left on 06May2021 at 08:50 AM (lot number: EW0173) as single dose for COVID-19 immunisation. Medical history included blood pressure high (patient thought the diagnosis date was last year, she was not taking any medication it's mild high blood pressure) and surgery (6 weeks ago). Concomitant medications were not provided. No medication before the shot. Yesterday (06May2021), the patient had the Pfizer (first) shot and was since then patient was in Emergency Room. The patient experienced after having covid vaccination, anaphylactic reaction. Patient got the shot 06May2021 at 8:50 and the reaction started and that change of her body and increased heart rate and everything, increased quickly for 10-15 minutes. Patient stated she was very painful (Covid vaccination) for few hours. Patient was still experiencing some symptoms. She added, there was new symptoms her face was bright red and puffy and injection site had enlarged and swollen like 5 inches, after her injection an Ambulance came and they rush her to the emergency room and they gave her Benadryl and Epinephrine (treatment) because she couldn't breath, she had a rash on left arm, dizzy, increased heart rate and she could not breath and in the Hospital they gave her "Morsef-Metho prednisone (Further not clarified) (treatment). Hospitalization not clarified. Lab data included heart rate was increased on unspecified date. Treatment received for the event included on prednisone 20 mg 2 tablet for 4 days and then Cetirizine 10 mg, one tablet by mouth twice daily for 4 days. The outcome of the events not recovered.
57 2021-05-22 swelling Pt broke out in itchy rash (hives) on right side of chin/mouth. It is the same side as her dental w... Read more
Pt broke out in itchy rash (hives) on right side of chin/mouth. It is the same side as her dental work and no where else on her body. She is on antibiotics (amoxicillin) for dental issues but has been on the amoxicillin for a few days and the rash started later the day/the next day after her vaccine so she thinks it was caused by her vaccine. She was told to take Benadryl, apply cortisone and use ice if needed. The area appeared swollen but pt states that this was because of dental work.
57 2021-05-23 oral herpes Marked nerve pain along spine/back and back of arms, plus fever blisters on lips
57 2021-05-26 peripheral swelling Breast pain; Neck pain; Swelling in armpit; Shoulder pain; Pain in armpit; This is a spontaneous rep... Read more
Breast pain; Neck pain; Swelling in armpit; Shoulder pain; Pain in armpit; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number: UNKNOWN), via unspecified route of administration on 02Mar2021 at 09:30 (at the age of 57-years-old) as unknown single for Covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included other medication used in 2 weeks. The patient did not have any allergies to medications, food, or other products. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced armpit pain, shoulder pain, swelling arm, pain neck and breast pain on 02Mar2021 at 15:00. No therapeutic measures were taken for armpit pain, shoulder pain, swelling arm, pain neck and breast pain. Outcome of event of armpit pain, shoulder pain, swelling arm, pain neck and breast pain was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
57 2021-05-26 swelling face face swollen; mild to moderate joint pain in knees and hip; Sore arm (injection site); This is a spo... Read more
face swollen; mild to moderate joint pain in knees and hip; Sore arm (injection site); This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not known), via unspecified route of administration in right arm on 15Mar2021 at 13:00 (at the age of 57-years-old), as a single dose for COVID-19 Immunisation. The Medical history included hypothyroidism. Concomitant medication included synthroid 75 ug QD for unknown indication from unknown-to-unknown date, and COVID vaccine on 22Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and the patient had not been tested for COVID-19 Since having the vaccine. The patient experienced mild to moderate joint pain in knees and hip, face swollen, Sore arm (injection site) on 16Mar2021 at 6:00. No treatment was taken for the events. The clinical outcome of the pain in joint, swelling face and vaccination site pain was unknown. Information about lot/batch number cannot be obtained. No further information is expected.
57 2021-05-29 oral herpes Cold sore on lip 9 days after vaccine. Received the 2nd dose and had a cold sore again 9 days after... Read more
Cold sore on lip 9 days after vaccine. Received the 2nd dose and had a cold sore again 9 days after the vaccine
57 2021-05-31 swollen extremities 57 y/o female with past medical history of Asthma who presents with palpitations post vaccination ad... Read more
57 y/o female with past medical history of Asthma who presents with palpitations post vaccination administration. Patient states that this is her second dose in the two-dose series. Patient denies previous reaction with first dose. Patient states that received todays vaccination to the R arm. Patient states that she was nervous prior to receiving todays injection and that she suffers from anxiety (undiagnosed). Patient also states that she takes Albuterol daily and Montelukast. This NP explained to patient that Albuterol is a rescue medication and not a controller, that she is taking the medication incorrectly. I advised the patient to follow up with her primary physician to discuss a controller such as Pulmicort instead of using a rescue drug as maintenance. NP, CNO and Paramedics at patient side. Patient with noted peripheral edema. Patient initial vitals showed tachycardia and hypertension. Patient initial vitals (153/88 BP, 127 HR, 98% RA, Resp 16 and EKG Sinus Tachy). Patient states that her palpitations come and go. Patient denies sore throat, difficulty swallowing, chest pain or difficulty breathing. Patient monitored for 30 mins with no improvement of symptoms (Patient remained Hypertensive (171/88, 172/87, 174/94) and Tachycardia (105-127) and it was determined to call Fire Rescue. Fire Rescue assessed patient and advised to seek further medical attention but patient refuses. Patient signed AMA with rescue and patient was provided with the AshBritt Logistics and IEM Health AMA form, patient signed and ambulated off site without difficulty.
57 2021-05-31 peripheral swelling Both knees tightened up, with swelling (fluid on both knees), on 04/12/21, my right index finger had... Read more
Both knees tightened up, with swelling (fluid on both knees), on 04/12/21, my right index finger had a sharp shooting pain in the mid knuckle that radiated up and down my finger. My finger swelled up and was extremely painful to touch or use. The pain increased and knuckle became itchy and tight as if I had a hive on it. The pain and swelling lasted for 9 or 10 days. Finger felt normal on or about 04/21/21. Both knees continue to be swollen and painful in front and back, with going up and down steps, and sitting down and standing up. I have not yet contacted my primary care physician. I was hoping my knee pain would go away on its own.
57 2021-05-31 swelling Tongue tingling, numbness, ?mild swelling - self-resolving.
57 2021-06-01 lymph node pain This non-serious spontaneous report (USASP2021068522) was reported to Amgen on 03/MAY/2021 by a cons... Read more
This non-serious spontaneous report (USASP2021068522) was reported to Amgen on 03/MAY/2021 by a consumer and involves an approximately 57 year old female patient who had swollen lymph node for reported 'node on the right side under the chin/jaw is hurting and swollen [PT: lymph node pain], never knew to leave her sureclick out at room temperature before injecting has not been doing it previously patient states optumrx told her enbrel could be frozen for four days [PT: wrong technique in product usage process], she had been storing in the freezer instead of in the fridge [PT: product storage error] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel, Single Dose Prefilled Autoinjector on an unknown date. On an unknown date in the past that happened when she took something she had allergy. On 20/MAR/2021, the patient had COVID-19 vaccine and on an unknown date in 2021 the patient's lymph node on the right side under the chin/jaw was hurting and swollen. The patient wanted to know was her system building antibodies from the vaccine or could this happen from being off Enbrel because the patient had been off it a couple weeks. On 23/APR/2021, a few days ago, Friday or Saturday (30/APR/2021 or 01/MAY/2021) the patient stated that her son put her Enbrel in the freezer instead of in the fridge, which she just noticed after having attempted three doses. She stated they malfunctioned when she pulled the cap straight off and it looked like more came off than normal. When the patient pressed down the patient was not sure the needle was even going in. It stuck down but the color didn't change. Also the patient stated that she never knew to leave her Sureclick out at room temperature before injecting and had not been doing it previously. No treatment information was received. The outcome of the events lymph node pain, wrong technique in product usage process, product storage error was reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the event lymph node pain. The causal relationship between the events lymph node pain, wrong technique in product usage process, product storage error and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested.
57 2021-06-01 peripheral swelling, swelling face swelling and numbness in lip and chin area of face. fingers on right hand numb, tingling sensation... Read more
swelling and numbness in lip and chin area of face. fingers on right hand numb, tingling sensation, and swelling. symptoms have lessened since this morning but still prevalent.
57 2021-06-01 white blood cell count increased, peripheral swelling Severe pain in every joint. Pain so intense i could not stand or even pull myself off the couch. Too... Read more
Severe pain in every joint. Pain so intense i could not stand or even pull myself off the couch. Took ambulance to Medical Center. Admitted. Severe swelling left knee and left thumb joints to wrist. Excruciating pain. Non-ambulatory, HBP
57 2021-06-02 peripheral swelling red rash wrist, itching, about a 3-4 inch area; red rash wrist, itching, about a 3-4 inch area; Jaw ... Read more
red rash wrist, itching, about a 3-4 inch area; red rash wrist, itching, about a 3-4 inch area; Jaw up to ear, under eye, eye lid, down her neck, left side of windpipe, back of neck, shoulder and left side of forehead lost sensation, lost sensation in part of arm above elbow.; tingling sensation in mouth, tingling lip; upper lip went numb; tingling half face; Headache; left arm swelled up; Elevated Heart Rate; Brain fog; dry mouth; funny sensation in her mouth; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0158, Expiration Date: 31Jul2021), via an unspecified date of administration in left arm on 14May2021 at 09:35 (at the age of 57-year-old) at first dose, single for COVID-19 immunization. The vaccine was administered at hospital. The patient did not receive other vaccine within four weeks prior to the first administration date of the COVID-19 vaccine. Relevant medical history included dental work to left upper molar done on 11May2021. She was given anesthesia and stated all this resolved. She had the procedure at 10:00. The patient was not receiving concomitant medications. On 14May2021 within 10 minutes of receiving shot the patient experienced tingling sensation in mouth, tingling lip, half face, and upper lip went numb. Her jaw up to ear, under eye, eye lid, down neck, left side of windpipe, back of neck, shoulder and left side of forehead lost sensation. Left arm swelled up and lost sensation in part of arm above elbow. The patient went to the emergency room for these symptoms and she was monitored there. The patient stated she is about 90% resolved of these symptoms, but they are not completely gone. On 14May2021 had headache that has resolved but she keeps having a sensation like she is about to get a headache on the left side of her forehead and also had elevated heart rate. She stated that her heart rate was elevated for many hours. It was still higher than normal for her when she left the emergency room. On 17May2021 had right red (rash), very itchy area on right wrist. Came on all of the sudden and was fire red and very itchy, was about a 3-4 inch area. Dissipated within an hour. She is still experiencing brain fog since an unspecified date in May2021, it is improving; but she had to take a half a day off of work the day before reporting to rest. Dry mouth and a funny sensation in her mouth are still lingering since an unspecified date in May2021. The patient stated that she called her doctor's office the day before and is awaiting a call back. She says the emergency room doctor told her to follow-up with her doctor and that the emergency room doctor also advised her not to get the second vaccine. They stated that she could potentially have a long-lasting vaccine effect. The patient asked what are the risks of her getting the second shot since she had such a severe reaction that is taking so long to resolve. Rash resolved on 17May2021, headache resolved on 14May2021, final outcome of heart rate increased was unknown, dry mouth and a funny sensation in her mouth had not resolved, while all the remaining events were resolving.
57 2021-06-02 swelling Postmenopausal Menstruation, bleeding and cramping; Small lump in the inner thigh; inappropriate sch... Read more
Postmenopausal Menstruation, bleeding and cramping; Small lump in the inner thigh; inappropriate schedule of vaccine administered; Extreme premenstrual syndrome in breast and under armpits and under lymph nodes; Passing small blood clots; started having periodic premenstrual symptoms, like cramps; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0151), via an unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunization. The patient's medical history included cysts (fibrocystic cysts in her breast and a baker's cyst behind the knee many years ago), Ovarian surgery, blood pressure and blood potassium. The patient's concomitant medications were not reported. The patient stated that she read an article online about the women who took the Pfizer vaccine should report if they were having menstrual issues. She stated that she took her first dose of the Pfizer vaccine on 13Apr2021, and on 12May2021 she started having periodic premenstrual symptoms, like cramps. She stated that she has her regular menstrual cycle now, and she had cancelled her second dose. Because of her side effects she put off her 3 week booster shot that was scheduled for 28Apr2021 at 1400. She did not show up and was waiting to hear from a couple physicians regarding a lump on her inner right thigh that was moving around. She had trouble finding it the next day. She checked the other side to see if it had to do with fat composition or whatnot. It disappeared and she did follow up with her primary physician on it. Her primary physician said that if it had been a blood clot, she would have felt pain, but was not sure about that. Patient stated that she has not been able to find the lump. The patient's physician said that the patient could reschedule the vaccination as she could have it within 42 days. The patient stated that about a week and a half ago, she experienced extreme premenstrual syndrome in her breast and under her armpits and under her lymph nodes, cramping on monday and tuesday and some time yesterday, and the last 2 days she has been passing small blood clots like menstrual. The patient stated that the PMS has subsided somewhat. The patient has been taking ibuprofen. She has not had PMS or a period for at least 5 years. Last night, the patient stated that she was on the internet reading articles regarding the Covid vaccination and menstruation issues, and it is being reported but not fully. The patient described as: it seems like they were trying to keep it hush. The patient had side effects so bad over the weekend, the past weekend. The patient scheduled an appointment with a gynecologist whom she will visit in the middle of June because of these symptoms. The patient stated that she was afraid that she will get a mammogram and was not sure what's going on. Patient described that it was a kind of weird. The patient noticed the lump around approximately 24Apr2021 or 25Apr2021. It would have been between 2 and 3 weeks after the first shot, not even 3 weeks. The patient stated that she visited her physician in the first week of May and told her physician that she was having trouble finding it, then she felt it and didn't feel it again. It made her very queasy the first time she felt it. The patient stated that she had cysts in the past. She had fibrocystic cysts in her breast and a baker's cyst behind the knee many years ago. The patient stated that the cysts felt weird like soft and were moving around. It made her queasy. The patient stated that she has had the premenstrual syndrome in her breast and under her armpits and under her lymph nodes for at least a week. She used to get this during her monthly cycle during that time, she forgot what they call is severe PMS. The patient stated that she was going through very severe PMS just like that up until 2015. There was a year she had an ovarian mass removed and her fallopian tubes. She only has one ovary left. Once her period went away it went away. She never suffered, maybe slight PMS until she was fully into menopause. It has been this last week. She couldn't get out of bed because she had cramping and was in pain. She never used to cramp except in high school. The patient sated that she doesnt really feel lumps in her lymph nodes, it is just very tender and her nipples were highly sensitive. Underneath and along her rib cage and under her armpits is very warm to the touch. It is like a very bad premenstrual syndrome. It is definitely not warm or hot anymore, it has gotten better. The swelling has gone down, and she last noticed any blood clotting last evening and the clots were tinier like little dots. The blood clots started on monday 17May2021. The patient had cramps when she was in bed in the morning, then after she took pain medicine it subsided. The patient stated that she had no cramping today. The first time she had cramping was Monday 17Apr2021. The last time she had cramps was yesterday. The worst was on tuesday on 18May2021. Tuesday night was the worst for the blood clots too. She doesn't know. She hadn't had them for 5 years then it came upon recently. She doesn't know if she has recovered completely. She doesn't know if the cramps or the blood clots will return. If it goes like a normal cycle like before pre-menopause it will go away and then come back the next month. The patient stated that after she urinated today, she did not see any blood, and she was not using a pad. The blood clots have pretty much cleared up. The patient stated that she was reading and looking on the internet at ingredients and it was so scary and she was really scared. Patient stated that it was 42 days since her first dose. It would have been 42 days yesterday within the time limit to have the second shot of the booster. Now it is the forty third day and she has not had it. She was reading that it can be given 90 to 120 days. She is getting mixed messages. The people she lives with are high risk, and that's the only reason she got it. The case was assessed as serious. The patient stated that she was taking Ibuprofen and her symptoms subsided somewhat. Treatment was taken for events. The outcome of the events was resolved for cramps and resolving for other events. Information for lot number has been requested.
57 2021-06-03 lymph node pain I woke up at 6 am with numbness in my left arm and hands, I went to work and it kept progressing, I ... Read more
I woke up at 6 am with numbness in my left arm and hands, I went to work and it kept progressing, I took Claritin, drove home and slept for 2 days, I was totally out of it, I only got up to go to the bathroom or drink something. I was good for 24 hours then I was so fatigued slept 2 more days, I woke on the 18th I was numb, I woke up drooling, my whole left side was numb I had some drooping in my face and my boob. I did a tele med visit that morning , My doctor started me on a prednisone pack, Lymph nodes and my breast for very tender on left side. I went to see neurologist bc symptoms were not getting better and I was extremely fatigued, which is not me, I also have sever hip pain, that I never have had before. The neurologist diagnosed me Sensory deficit disorder on the left side of my body.
57 2021-06-04 swelling This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant fe... Read more
This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN 6199 and Expiration Date: unknown) via an unspecified route of administration in left arm in Mar2021 at 05:15 PM as 2nd dose, single dose for COVID-19 immunization. Medical history included high cholesterol and allergies (food, environment and mold trees). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient received Vitamin D, Vitamin C, Vitamin B12, Zyrtec, Singular and simvastatin in two weeks of vaccination. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269 and Expiration Date unknown) via an unspecified route of administration, in left arm in Feb 2021 at 16:30 as single dose for COVID-19 immunization. Patient did not receive any other vaccine in four weeks. On 07Mar2021 at 12:00, the patient experienced left side of neck has swollen knot and area around it. No treatment was provided for the event. On an unspecified date, event resolved. No follow-up attempts are Possible. No further information is expected.
57 2021-06-07 fluid retention, swelling face, swelling could not catch her breath if she moved; face swelled, too, it was hard to go down everyday; there i... Read more
could not catch her breath if she moved; face swelled, too, it was hard to go down everyday; there is too much fluid in her body; she believes it's swelling; stomach hurt; abdomen hurt; bloating/swell of stomach; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179, Expiration date: 31Aug2021), via an unspecified route of administration on 10May2021 between 07:00-10:00 (at the age of 57-year-old), as 2nd dose, single dose in left arm for COVID-19 immunisation. The patient's medical history included heart dis-functioning, body was slowed and a little overweight. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8731, Expiration date: 31Jul2021), via an unspecified route of administration on 19Apr2021 between 07:00-10:00 (at the age of 57-year-old), as single dose in left upper arm for COVID-19 immunization and experienced stomach hurt and abdomen hurt. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021 morning, after the second shot, the patient experienced stomach hurt, abdomen hurt and bloating/swell of stomach. Patient reported that her stomach was bloated and felt she could not catch her breath if she moved, for which the patient went to the emergency room on 30May2021 and got released on 31May2021. Doctor told her that there was too much fluid in her body. After second shot, patient's face swelled, too, it was hard to go down every day. Her stomach got extended like a balloon. Patient believed it was swelling. When patient was due for her second dose, she really didn't want to get it, because she felt hurt so bad and the doctor advised her to get the shot to be on the safe side. The patient underwent lab tests and procedures which included chest X-ray: normal on 30May2021. The clinical outcome of the events stomach hurt, abdomen hurt, bloating/swell of stomach was not resolved and clinical outcome of all other events was unknown.
57 2021-06-08 swollen extremities Patient presented to the ED on 5/13/2021 with perforation of sigmoid colon due to diverticulitis and... Read more
Patient presented to the ED on 5/13/2021 with perforation of sigmoid colon due to diverticulitis and was subsequently hospitalized. Patient received second vaccination dose on 5/21/2021, and on the same day patient presented to the ED on 5/21/2021 with pedal edema. These visits are within 6 weeks of receiving COVID vaccination.
57 2021-06-08 peripheral swelling had swelling all the way up her arm and to her shoulder and to the shoulder blade and almost down to... Read more
had swelling all the way up her arm and to her shoulder and to the shoulder blade and almost down to the elbow; hematoma; hot and its feels like a line a fire into her palm where it was on the nerve; The second dose, the caller was down for about three days.; Second dose: extreme nausea ; Second dose: extreme headache ; Swelling at the injection site; This is a spontaneous report from a contactable female consumer (patient) reported for herself. A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0178, Expiration date: unknown), via unspecified route, administered in left arm on 27May2021 (at the age of 57-year-old) as 2nd dose, single dose for COVID-19 immunisation. patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW976, Expiration date: unknown), via unspecified route, administered in right arm on 06May2021 (at the age of 57-year-old) as 1st dose, single dose for COVID-19 immunisation. The patient medical history includes ulcer. Concomitant medications were not reported. The patient historical vaccines include allergy shots and she experienced swelling as a reaction. The swelling happened after every allergy shot, she ever had, this was 20 years ago. The swelling would start about a day later. The caller would get one allergy shot on a Monday and then one shot on a Friday. The caller also explained he was diagnosed in the fall of 2020 and the caller cannot take Ibuprofen because of this. On 27May2021, after the vaccination, the patient experienced vaccination site swelling, had swelling all the way up her arm and to her shoulder and to the shoulder blade and almost down to the elbow. The swelling is very raised and hot and it felt like a line of fire into her palm where it was on the nerve. The caller thinks it's a hematoma now. The swelling is now the size of an egg in both shape and depth on 29May2021, patient experienced headache and nausea for 2 days. On an unspecified date patient also experienced feeling down for 3 days. The reporter assessed all events as non-serious. The caller explained he will not get the booster vaccine if Pfizer offers it. also explained that Swelling at the injection site has improved and now it is down to the hematoma the size of an egg. The hematoma is sitting on a nerve and the only thing the caller can do is ice it until it goes away. The outcome of the events mentioned as vaccination site swelling recovering. Nausea, headache and fatigue recovered on 31May2021 and the outcome of peripheral swelling and burning sensation was unknown. No follow-up attempts possible. No further information expected.
57 2021-06-10 lymph node swelling Systemic: Lymph Node Swelling-Medium
57 2021-06-14 lymph node swelling 57 y.o. female with PMH significant for multiple comorbidities including history of obstructive slee... Read more
57 y.o. female with PMH significant for multiple comorbidities including history of obstructive sleep apnea, chronic left shoulder pain s/p surgery in the past, right carpal tunnel surgery recently, came into the ER from home with complaint of shortness of breath. Patient was in her usual state of health at least until last Tuesday when she got her second Covid shot, starting Wednesday she started to have pleuritic chest pain, followed by shortness of breath. Shortness of breath progressively was getting worse, increased on exertion, subsequently was short of breath at rest and even on talking. Patient also noted frothy sputum tinged with blood. Secondary to above patient initially had a televisit with PCP early this morning and was instructed to come to ED. On further questioning patient denies complains of associated nausea, vomiting, diarrhea abdominal pain. Denies any fever, chills. Denies any other complaints of melena or hematochezia In the ED further work-up including a CT angio pulmonary showed evidence of PE. pt was treated and discharged the next day on Xarelto. On 6/13/21, pt presented back to ED with Chest heaviness and shortness of breath for 3 days Patient with recent diagnosis of unexplained pulmonary embolism. She was loaded with Xarelto for 21 days and subsequently is taking the full daily dose now. Ultrasound of legs was not performed to her initial hospitalization. CTA was repeated today and does not show new pulmonary emboli. CTA on May 17 showed small pulmonary emboli in the lobular in segment mental left lower lobe pulmonary arteries as well as a segmental right middle lobe and lingular pulmonary arteries. She had a left pleural effusion. This was later tapped. Cardiac echo obtained on 518 showed a small pericardial effusion. LVEF at that time was normal. RV systolic pressure was estimated at 36 mmHg. This is only slightly elevated. The patient is normally very active and wanted to get back to her normal activities. On Thursday she did some exercise and subsequent developed her current symptoms of chest heaviness and shortness of breath. She backed off on the exercise. She now came to the emergency room. Troponin is negative. EKG has nonspecific changes. Repeat CTA is now not showing pulmonary embolism. There is no significant pericardial effusion or pleural effusion seen. No evidence of recurrent pulmonary emboli and pt was discharged home.
57 2021-06-14 sepsis I almost died when I arrived at the hospital. I was admitted and stayed there for 6 days for treatme... Read more
I almost died when I arrived at the hospital. I was admitted and stayed there for 6 days for treatment. My blood pressure was 30/50. The Doctors did not know what was wrong and ended up being diagnosed with a septic kidney and the Dr. said that normally that occurs from a UTI and I have never had a UTI; however, now, I have three and I just came from the Dr.'s office today with another checkup.
57 2021-06-14 white blood cell count increased On Day 4 post vaccine I started getting heaving slime drainage in the back of my throat causing gagg... Read more
On Day 4 post vaccine I started getting heaving slime drainage in the back of my throat causing gagging and choking, Day 5 post vaccine I have extreme fatigue, headaches, nausea, severe stomach cramping and muscle pain and on Day 12, I am still experiencing symptoms which affect my ADLs. At the advice of the Nurse Line I went to the ER on Day 10, which resulted in symptoms consistent with bilateral fluid in ears, sinus drainage, severe stomach cramping, nausea, and extreme fatigue. Zofran was given, mucinex, and diagnosis of Lymes - which later test was negative. No definitive Diagnosis at this time.
57 2021-06-15 lymph node swelling Neck ache right away after injection. Next morning I had swelling in lymph nodes under my armpits on... Read more
Neck ache right away after injection. Next morning I had swelling in lymph nodes under my armpits on both sides. My left side was more swollen. I also had fatigue for 3 days.
57 2021-06-16 swelling hemorrhagic cyst; Breast pain and tenderness began after 2nd shot; Breast pain and tenderness began ... Read more
hemorrhagic cyst; Breast pain and tenderness began after 2nd shot; Breast pain and tenderness began after 2nd shot; uterine tract infection; abdominal pain; swelling; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 57-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (also reported as on 28Mar2021, pending confirm) (Batch/Lot Number: ER8731) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 57 years old. Patient was not pregnant. Medical history included Colon surgery in 2017, followed by colon cancer chemotherapy in 2017- 2018, follow up CT scans performed every 6 months. CT scan on 04Apr2021 showed no observation of cyst on ovary. Historical vaccine included first dose of COVID 19 vaccine (Brand: Pfizer; Lot number: ER8733; Vaccine location: Left arm) on 28Mar2021 11:00 AM). Concomitant medications included cetirizine hcl (CETIRIZINE HCL) 10 mg taken for an unspecified indication, start and stop date were not reported. The patient experienced hemorrhagic cyst (medically significant), breast pain and tenderness began after 2nd shot, uterine tract infection, abdominal pain, swelling, all on 19May2021 with outcome of not recovered. The patient underwent lab tests which included CT scan: no observation of cyst on 04Apr2021, ultra sound Retroperitoneal of uterine, ovaries, kidneys, bladder, a complex lesion was identified in right ovary measuring 14.3 x 15.7 x 8.2 cm on 25May2021. Adverse event reported as: Breast pain and tenderness began after 2nd shot and lasted approximately 30 days. On 19May2021 had symptoms of uterine tract infection, abdominal pain, swelling. On 25May2021, primary care doctor ordered an ultra sound Retroperitoneal of uterine, ovaries, kidneys, bladder and a complex lesion was identified in right ovary measuring 14.3 x 15.7 x 8.2 cm, may represent a hemorrhagic cyst. Left ovary not visualized. Followup is planned with gynecology surgeon. AE resulted in: Doctor or other healthcaremprofessional office/clinic visit. The treatment received for events included: antibiotic to treat infection. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Additional information is requested.
57 2021-06-18 lymph node swelling This is a spontaneous report from a contactable consumer or other non-health care professional (pati... Read more
This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: EW0173), via an unspecified route of administration, administered in arm left on 12Jun2021 10:00 (at the age of 57-year-old) as single dose, for COVID-19 immunization. The medical history included ongoing low blood platelet (this was diagnosed 3 years ago, at least). The patient's concomitant medications were not reported. The patient did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine and did not receive additional vaccines administered on same date of the Pfizer vaccine. The patient stated that she saw something on the information the caller was given after receiving the first dose Pfizer Covid Vaccine about if the patient was on a blood thinner or had a blood disorder and she reported low blood platelets. On 13Jun2021, the patient didn't really have any problems besides a sore arm (next day after receiving the first dose Pfizer COVID-19 Vaccine) and got really sick. On 14Jun2021, the patient began to have nausea around midnight today, which was awful but the nausea was kind of improving and still had the nausea; the patient had vomiting began around midnight on the same day, it had been few hours since vomited and patient did not feel very good but it had improved; had vomiting began around midnight and had been a few hours since the patient vomited and she did not feel very good; the patient stated that everything came on at once between midnight and she was referring to chills which was not all the time, just got the chills and goose bumps and the chills have improved, bad headache which she had not felt this way, dizziness which was off and persisting, and muscle pain and thought that it was just stiff neck but it was all over and the muscle pain was the same; the glands under the ears are swollen and really hurt and patient stated that it started later after everything else started, which was right under the ears. The patient stated that patient went to bed fine and woke up just sick (got really sick last night). The patient stayed in bed most of the time. The caller states the glands under the ears being swollen and hurting is persisting. The patient mentioned that the headache got better for a little bit and then came right back. Therapeutic measures were taken as a result of bad headache with one rapid release Tylenol. The description of Product Complaint included: Description of complaint: The caller reported a bad headache after receiving the first dose Pfizer COVID-19 Vaccine. The caller took one rapid release Tylenol. The headache got better for a little bit and then came right back. The caller also stated she did not had her glasses on and was trying to find the information requested on the bottle. The caller asked her husband for assistance finding the information on the medication bottle. Product was Equate extra strength Acetaminophen 500mg; Lot: P123338; Expiration: Dec 2023; Product strength and count size dispensed: 500mg, 225 gel caps count size; and the sample of the product was available to be returned, if requested. The reporter was informed she may possibly receive a mailer in 3-10 business days and the packaging was sealed and intact. The patient taking Pfizer Covid Vaccine to get vaccinated against COVID-19. The patient was unable to provide address, telephone number or email and informed that she had not been to the doctor in a while. Further added that, the patient stated that she had one more dose of the Pfizer COVID-19 Vaccine to take in three weeks. The outcome of the event pain in arm, nausea, vomiting, chills was resolving; the outcome of the event got really sick, glands swollen, dizziness, muscle pain was not resolved; while the outcome of the event bad headache, goosebumps, localized pain, and neck stiff was unknown. Information on Lot/Batch number was available. Additional information has been requested.
57 2021-06-18 lymph node swelling Noticed swollen lymph node under left arm.; This is a spontaneous report from a contactable consumer... Read more
Noticed swollen lymph node under left arm.; This is a spontaneous report from a contactable consumer, patient. A 57 years old non pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID 19 mRNA Vaccine; Lot number: EN6203) via unspecified route of administration in the left arm on 16Mar2021 at 9:45 am, as a single dose for COVID 19 immunisation. Medical history included mild asthma, only have one half of thyroid on unknown date. Patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID 19 mRNA Vaccvine; Lot number: EL3247), (age at vaccination was 57 years old) via unspecified route of administration in the left arm on 23FEB2021 at 9:00 am, as a single dose for COVID-19 immunisation. Patient was found to be allergic to honey. Concomitant medications reported were Synthroid tabs 50 mcg (UNKNOWN MANUFACTURE); QVAR RediHaler 80 mcg (UNKNOWN MANUFACTURE) for unknown indication from unknown date. Unknown, prior to vaccination the patient was not diagnosed with COVID 19. On 17Mar2021 10:00 am the patient experienced swollen lymph nodes. Since the vaccination, the patient had not been tested for COVID 19. The patient did not receive treatment for the reported events. The clinical outcome for swollen lymph nodes was recovering. No follow up attempts are possible. No further information is expected.
57 2021-06-19 white blood cell count increased Developed symptoms of Appendicitis in the evening of 6/15/21 and had an emergency Appendectomy on 6/... Read more
Developed symptoms of Appendicitis in the evening of 6/15/21 and had an emergency Appendectomy on 6/16/21. Presently experiencing surgical incision infection and recovering from the emergency appendectomy Started oral antibiotic on 6/19/21 Post-op follow up appt scheduled for 6/29/21
57 2021-06-20 lymph node swelling Supraclavicular adenopathy - 5-6 palpable nodes. Still present >24 hours later.
57 2021-06-22 swelling face On June 23, 2021 three hours following COVID-19 vaccination patient complaints of face swelling with... Read more
On June 23, 2021 three hours following COVID-19 vaccination patient complaints of face swelling with edema, palpitations, skin rash and respiratory difficulties. She visited the emergency room were symptoms were controlled and she was discharge home.
57 2021-06-23 peripheral swelling Two days after first Phyzer shot, I awoke to what felt like my entire right leg feeling electrocuted... Read more
Two days after first Phyzer shot, I awoke to what felt like my entire right leg feeling electrocuted. It only lasted maybe 20 seconds and then it went completely away That evening I noticed that I was starting to get swollen in my legs and by Thursday evening it had become much worse and for the next few days I needed to use Hydrocholorthiazide to start reducing the sudden and very uncomfortable swelling, which did work. During that time my oximeter was flashing with oxygen levels below ninety and my heart rate was flashing into the low forties. I was out of breathe, even while I was lying down. My blood pressure was also dropping. Eventful I went to the hospital on 04/16/21. My heart was always racing and all of the other sudden symptoms, after realizing that all of this was happening after my first Phyzer shot on 04/06.. I was admitted into the hospital on 04/16 and I was discharged the evening of 04/18/21. All of those side effects went away.
57 2021-06-23 swelling Lumps around the groin area
57 2021-06-28 lymph node swelling lump at meating of top of shoulder and left arm the next day and also vomiting the next day
57 2021-06-28 peripheral swelling 3/10/2021 right knee swollen and extremely painful. This was first call to dr. Ok after few days... Read more
3/10/2021 right knee swollen and extremely painful. This was first call to dr. Ok after few days. Then, 3/10 knee, 3/23 hip, 4/2 right pointer finger swollen extreme pain, 4/4 neck limited range of motion.4/8 -4/14 left shoulder. 4/16 start 800 mg ibuprofen. 4/16 red patch back of hand. 4/20 right shoulder pain unable to hold steering wheel. No range of motion. Start one week prednisone . Sent to Rheumotologist. Start with 40 mg. 4/23 right foot toes swollen and ache. 5/1 swollen left ring finger but no pain. 5/2 swollen right ankle no pain. 5/2 swollen left hand fingers and red patch extreme pain and no sleep.800 mg ibuprofen and etodolac no help. 5/16 left hand again swollen extreme pain. 5/22 left hand. 5/25 right hand. 5/27 shoulder,. 6/4 feet.
57 2021-06-29 peripheral swelling unable to use my arm as it is still swollen; unable to use my arm as it is still swollen and painful... Read more
unable to use my arm as it is still swollen; unable to use my arm as it is still swollen and painful; This is a spontaneous report from a contactable consumer (patient). This 57-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 03Apr2021 at 12:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included suspected COVID-19 in Jan2021; the patient stated she probably had COVID at New Year but was not tested and she spent a few days in bed and was exhausted for all of Jan2021. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received some antibiotics from unknown dates for unknown indications and experienced allergies; the second dose of shingles vaccine on 09Feb2021 in the left arm (at 57-years-old) for immunisation and experienced a bad reaction; and the first dose of BNT162B2 (lot number unknown) in the right arm on 13Mar2021 at 12:15 (at 57-years-old) for COVID-19 immunisation and experienced very painful and swelled up. The patient reported that since getting the second shot in her left arm on 03Apr2021 she had been unable to use her arm as it was still swollen and painful. Her doctor put her on a week of steroids, anti-inflammatory medications and muscle relaxers to try and reduce the swelling. The patient reported having had a shingles shot in that arm in early Feb2021 with a bad reaction that went away after a week; which was why she had the first shot of BNT162B2 in her right arm , which swelled up immediately and was very painful but started feeling better the next day. The events were reported as non-serious and did not require hospitalization; the event resulted in a physician office visit. The clinical outcomes of unable to use her arm as it was still swollen and painful were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
57 2021-06-30 swollen extremities 1. Severe headache. I developed a severe headache the next day that was a migraine but more resistan... Read more
1. Severe headache. I developed a severe headache the next day that was a migraine but more resistant than typical. It was severe and limited activity completely--put me to bed. It eventually responded to treatment but returned once the medication wore off for a total duration of about 3 days. I have chronic migraine and the severity and frequency of migraine substantially increased and remained increased after this vaccine, despite treatment adjustments by my neurologist, for about 2.5 months. Afer 2.5 months there was improvement in migraine, however not yet to baseline before the vaccines. I also had a severe headache for 1 day after the 1st dose in the series on 3-18-21 and some lesser increase in my migraine disorder, but only for about 2 weeks and then seemed to settle down a week before the 2nd dose. My ability to work is still limited because of this. I have limitations in work re-existing due to migraine that are worse since the vaccine. 2. Axillary swelling. The day after this vaccine, I noticed swelling and pain in my R axilla. It got worse over time. After about 3 days the pain subsided but the swelling persisted for about 10 days. At the worst, perhaps 3 days post-vaccine, I felt like I had a foam ball in my axilla when I had my arm resting against my body. I did not feel specific adenopathy or lumps. Just very soft swelling, filling the entire axilla. I am reporting as myself but am an MD After the 1st dose I noted swelling in R axilla incidentally in the shower 1 week after vaccine. It was gone in a couple days and there way no pain at any time.. I also had fatigue, marked, starting several hours after each dose and lasting through the next day. I had chills and body aches the day after the 2nd dose, but not the first. However, I was not febrile. Other than the migraine, my other side effects appear to have resolved.
57 2021-07-01 peripheral swelling I was at work and my arm started feeling very sore. It started hurting. By the time I got home from ... Read more
I was at work and my arm started feeling very sore. It started hurting. By the time I got home from work, my body was starting to ache. It progressively got worse to where I couldn't do anything. It was like everything hurt and I was like that for 3 days. I was a little bit better for about 3 weeks and it started all over again. It was to the point that I would go to work, come home, sleep, get up in the morning, get dressed, go back to bed, and then finally go to work. My legs, feet, ankles, knees all hurt. I could barely walk. I have a high pain tolerance. I was putting something in the refrigerator and got on my knees and starting sobbing because it hurt so much. I went to the doctor and they had me take some Tylenol and Aleve. It didn't help. Then my feet were swelling so bad that they were huge. I went back to the doctor and they ended up doing some blood work. They ended up testing me for rheumatoid arthritis and my numbers were very high. Now I have to see a rheumatoid arthritis doctor and he has me on some medicine. They had to put me on steroids to bring all the swelling down. It is somewhat manageable now, but it still hurts. I was in so much pain that I almost went to the ER, but I never did.
57 2021-07-03 swelling face, swelling Head face and jaw felt swollen like when a dentist administers novalvaine the pain in head and press... Read more
Head face and jaw felt swollen like when a dentist administers novalvaine the pain in head and pressure was causing me to lose my cognitive it was very scary I felt near death I talked myself through it kept moving my legs walk-in in place and ate yogurt and drank liquids to stay calm it started dissipating I 20 minutes by 3:30 symptoms subsided to slight headache
57 2021-07-05 lymphatic obstruction White blood cells were below 1 on Monday, repeat labs Wednesday they were above 1; Worsening lymphed... Read more
White blood cells were below 1 on Monday, repeat labs Wednesday they were above 1; Worsening lymphedema since Jan2021 or Feb2021; Joints hurt; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on 02Jun2021 (age at vaccination: 57-year-old) as dose number unknown, single for COVID-19 immunization. Medical history of the patient included adhesive tape allergy, iodine tincture allergy, lymphedema (worsening lymphedema since Jan2021 or Feb2021). Concomitant medications included Tocopherol (Vitamin E), naproxen sodium (Aleve), fulvestrant (Faslodex), Levothyroxine, Multivitamin capsule, Vitamin D for unspecified indication, started and stopped on an unspecified date. Patient previously took Macrobid on an unspecified date for an unspecified indication and experienced allergy. On an unspecified date in Jun2021, patient white blood cells were below 1 on Monday and her white blood cells were above 1 on Wednesday, worsening lymphedema since Jan2021 or Feb2021, joints hurt. MD is aware. Outcome of the events were unknown. Information about lot/batch number has been requested.; Sender's Comments: Limited information of white blood cell count prior to vaccine preclude a comprehensive causality assessment, underlying medical conditons of lymphedema and allergy may be contributory to events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
57 2021-07-06 peripheral swelling Burning throat 5 minutes after injection. Day after injection- sore throat, fever, body aches, naus... Read more
Burning throat 5 minutes after injection. Day after injection- sore throat, fever, body aches, nausea, vomiting, extreme thirst, arm burning, arm swollen, arm temperature hot, ear pain left side, neck pain left side, muscle cramps
57 2021-07-06 swelling Day 6 post second injection developed raised rash with itching, swelling, tenderness & warmth.
57 2021-07-10 lymph node swelling swollen glands in neck; This is a spontaneous report from a contactable health care professional, th... Read more
swollen glands in neck; This is a spontaneous report from a contactable health care professional, the patient. A 57-year-old non-pregnant female patient received an unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 16:00 (at the age of 57 years old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within two weeks of vaccine. On 26Mar2021, patient experienced swollen glands in neck. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event swollen glands in neck was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
57 2021-07-10 peripheral swelling Her feet feels like they are swollen; Dizziness; Nausesation; weird feeling from her knees down. It ... Read more
Her feet feels like they are swollen; Dizziness; Nausesation; weird feeling from her knees down. It is like a coldness, it feels like she has wet socks on. She feels it down to her ankles; weird feeling from her knees down. It is like a coldness, it feels like she has wet socks on. She feels it down to her ankles; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EW0173; Expiration Date: Aug2021), dose 1 via an unspecified route of administration, administered in Deltoid Right on 05May2021 around 2'clock or 3'clock (57 years age at the time of vaccination) as dose 1, 0.3 mL single for COVID-19 immunisation at Other- Stadium. Medical history included ongoing Pseudo Tumor (Has a VP shut for this), Kewari-1 (Commented this is a congenital birth defect), ongoing Renal dysplasia (Commented she has a stent in her kidney for this), ongoing all her valves are leaking, Tethered spinal cord (Had surgery for this years ago). Concomitant medications included blood pressure pills and a water pill, but no additional details provided. Patient reported that after first dose patient has had a weird feeling from her knees down. It is like a coldness, it feels like patient has wet socks on. Patient felt it down to her ankles. Patient was wondering if patient should get the second dose on 26May2021. Weird Feeling from knees down: It started that night on 05May2021. Patient was having issues with her shoes. Patient feet felt like they are swollen. Patient mentioned she does takes a water pill and has a VP Shunt. Her shoes feel tight on her. It is like Patient was retaining water. Patient was having swollen ankles and her feet were swollen. When probed for outcome and if event was still ongoing patient stated it was coming and going. Patient also later added Patient was having dizziness. It was periodically. Clarified it started the next day, 06May2021 . When probed for outcome patient sated it was like patient gets period of it. It was like a little vertigo. It comes and goes. Patient later clarified and confirmed outcome as it was getting better. Nauseation started the following day, on 06May2021. Patient initially stated it was pretty much going away. Later clarified and confirmed it has gone away. Patient had a little bit yesterday, but now Patient has recovered completely. The outcome of event Dizziness was recovering, for Nausesation was recovered on 16May2021 and for all rest events was unknown.
57 2021-07-11 guillain-barre syndrome Guillen Barre, Short term cognitive memory issues
57 2021-07-11 swelling Large asymmetrical rash appeared next day 7/8. Red, hot to touch, swole , very painful. Day 7/9: sa... Read more
Large asymmetrical rash appeared next day 7/8. Red, hot to touch, swole , very painful. Day 7/9: same symptoms, but worse. Rash was larger, and slightly itchy, very painful to touch. 7/10: redness stated to subside, still painful, slightly itchy. 7/11: symptoms lessening, but tender; 7/12: mostly gone, slight pain still noticeable . Was this a Type III Hypersensitivity or Allergic Arthus Reaction? ?Covid arm??
57 2021-07-12 lymph node swelling Severe headache/ back of head ached; neck ached; Nausea; fatigue; muscle pain; chills; swollen lymph... Read more
Severe headache/ back of head ached; neck ached; Nausea; fatigue; muscle pain; chills; swollen lymph nodes - left neck; generally feeling unwell; This is a spontaneous report from a contactable other health care professional, the patient. A 57-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via unspecified route of administration in the left arm on 26Mar2021 at 10:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as COVID-19 on unspecified date. The patient was allergic to aspirin and penicillin. Concomitant medications were reported as karma cleanse, hepata tox, heverts lymph detox and H, (MANUFACTURER UNKNOWN) for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. On 26Mar2021 at 11:30 patient experienced severe headache, back of head and neck ached, nausea, fatigue, muscle pain, chills, swollen lymph nodes of left neck and generally feeling unwell. The patient did not receive treatment for the reported events. On 21Jun2020, the patient had nasal Swab resulted positive, whereas on 03Aug2020 and 01Oct2020 it was negative, respectively. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of all the events severe headache, neck pain, nausea, fatigue, myalgia, chills, lymphadenopathy and malaise were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
57 2021-07-14 peripheral swelling Pain and mild swelling in left arm which had previously resolved lymphedema. Shot was administered i... Read more
Pain and mild swelling in left arm which had previously resolved lymphedema. Shot was administered in right arm.
57 2021-07-17 oral herpes tingle of cold sore left upper lip; painful bump on right side of tongue; Canker sore middle of lowe... Read more
tingle of cold sore left upper lip; painful bump on right side of tongue; Canker sore middle of lower lip; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 28Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma, diabetes, canker sores oral, cold sores. The patient had environmental allergy and peanut allergy. Concomitant medications included insulin (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ), amfetamine aspartate, amfetamine sulfate, dexamfetamine sulfate and dexamfetamine saccharate (ADDERALL), levothyroxine sodium (LEVOXYL), losartan (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC) all for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 07Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021, the patient experienced canker sore oral. It was reported that the patient had painful bump on right side of tongue, likely turning into a canker sore on 31Mar2021, might be tingle of cold sore left upper lip this evening on 31Mar2021. The patient mainly worried because these were not reported side effects, but were possibly symptoms of COVID. The patient would like to be able to see complete list of side effects of vaccine. The patient did not receive any treatment for the adverse events. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event canker sore middle of lower lip, painful bump on right side of tongue and tingle of cold sore left upper lip was not recovered. No follow-up attempts are needed. No further information is expected.
57 2021-07-17 peripheral swelling Trigeminal neuralgia; soreness at the injection site; pain in every single joint on that left side (... Read more
Trigeminal neuralgia; soreness at the injection site; pain in every single joint on that left side (pain in that left ankle, left knee, left elbow, left wrist); My ankle and my leg totally swelled up I couldn't even walk; the pain is originating right like my hip, not my hip bone more towards my buttocks but on the bone.; My ankle and my leg totally swelled up I couldn't even walk; the pain is originating right like my hip, not my hip bone more towards my buttocks but on the bone.; My right side of my body, my elbow my hands, its very, it's not like it hurts it's swell and its hurts.; All my veins were sticking out of my arm; could see my veins through my hand; see they were right under my skin on both sides in my hands and both sides my lower arm.; I couldn't even move my arm.; She weight 117lbs 3 days ago. She weighs 113lbs; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration administered in left arm on 28Mar2021 at 12:30 (at the age of 57-year-old), as a single dose for COVID-19 immunization at Pharmacy/drug store. The patient medical history included ongoing chronic obstructive pulmonary disease, emphysema, anxiety, car accident (1998), bacterial pneumonia (2 years ago in November), pain, arthritis, anxiety and cannot sleep. When she was in a car accident and she had two surgeries on her and she needed a third surgery but she told the doctor no. She had a fusion, a laminectomy at C4 through C6. Her second surgery, her doctor told her that he couldn't fuse a plate to a plate in her neck, so the second surgery he removed the plate and fused C4 through C7. He told her if he fused C3 then she wouldn't be able to move her jaw. The doctor used cadaver bones on her first operation. She doesn't remember the doctor telling her if he fused C3 she wouldn't be able to move her jaw and the pain doctor put on 2 fentanyl patches and they were taking them off every 2 days and they kept doing epidurals and that's ridiculous. Her doctor asked her why she kept getting epidurals when her neck was fused. She reports this was in relation to a card accident she was in in Feb1998. In Nov2019, she went to sleep and she was throwing up in her sleep and she aspirated and she wasn't even sick. She went to bed and her husband woke up and heard her and called the ambulance and she ended up in the ICU for 3 days in a comatose state. She had no idea where she was. She didn't remember a thing. She woke up in the ICU and saw her daughter. She had to be sedated in the ICU, she reports she was punching the nurse. She was diagnosed with bacterial pneumonia. She stated she had no symptoms of pneumonia at all and she would know because she gets pneumonia every single year. They never tested her for Covid 19 in Nov2019. Maybe they didn't even know about Covid 19 at that time. She had COPD and couldn't got the shot earlier but had go to doctor to fill out, because he fills out these forms but she guess he didn't have any form that was available to fill out so you gonna see it today like and does not now she was able to get vaccine. 2 years ago in November, she had Pneumonia and everyone said that it was impossible that you have COVID but was on deathbed she was actually didn't remember anything when she went the bed until she woke up 4 days later, was in I.C.U for 3 days and wasn't able to get new appointment to get an test to see if she has antibodies to that, if had antibodies to the COVID because she couldn't even take appointment because they are making it so hard on things they don't have computer themselves and don't know how to do that on her cell phone to attach that Medicare card so she wasn't able to get appointment her daughter had to do it for me. Both her husband and she had COPD and she's sure she has emphysema.She has not been diagnosed with emphysema but her mother had it and she knows so much about things. She was in a car accident while a long time ago and had all kind of pain killers, currently on morphine sulfate extended release from years (she takes morphine immediate release 30mg just once a day when needed. She reports the morphine immediate release makes her speed up, like speed talking like she's a crazy. The dose is too much for her. It was prescribed when she weighed 98 lbs., now she weighs more) taken for pain at a dose of 60 mg twice a day and morphine sulfate immediate release at a dose of 30 mg as needed (once a day), alprazolam (ZOLAM) taken for severe anxiety at an unknown dose for four times a day, amitriptyline but not for depression but for as sleeping pills at a dose of 100 mg once a day (before bedtime), diazepam at a dose of 10mg four times daily taken for muscle relaxant therapy (she can't sleep very well) from an unspecified start date and ongoing. The patient did not take any prior vaccinations (within 4 weeks). Patient was still using the products and further stated that they never even asked her if she was on any kind of medicine or if ever had like any kind of bleeding disorder or anything like that and when she got home she got to leave the whole thing and what do you call it, she had 2 things Trigeminal neuralgia, she hated its like you are getting brain freeze but it goes to eye and its one of those painful conditions known to mankind and like its kind a irrational but when its really cold or she was under lot of stress it it comes back and always have to check with doctor if it happens again and she had COPD, never been diagnosed but she knows she have because her grandmother did and the other thing was bleeding thing its called Von Willebrand factor and that causes easy bleeding and bruising and she did not bruise or bleed easily but she knowns because they had to test her son when he was young and her ex-husband didn't have it and her mom and aunt were twins and they used to bruise easily both of them all the time and knew her son got it from her. Patient did not receive any prior Vaccinations (within 4 weeks) and did not had history of previous immunization with the Pfizer vaccine. Patient reported that, it wasn't an allergic reaction where she had to go the hospital and get a EpiPen or anything like that but she got the shot in her arm on Sunday (28Mar2021). When she went to sleep everything was fine but when she woke up she couldn't even move her arm and on 29Mar2021, she had the mild reaction of soreness at the injection but it was considerably the most that with her leg, ankle and leg totally swelled up, and couldn't even walk, she was supposed to go to doctor, but anyway she can't, she was driving and her legs with whole ankle swollen and it also its not going down side arachnoid nerve but the pain was originating right like in hip, not her hip bone more towards my buttocks but on the bone, she forgot her anatomy and then its affecting all her joints, she had pain in that left ankle, left knee, left elbow, left wrist, she had pain in every single joint on that left side except her hip because she already has pain in her hip. Her joint pain and swelling started the next day after the Covid 19 vaccine. She had arthritis (Intent:History) too but never got affected like this where everything will joint on her right side of my body, elbow, hands, its very, it's not like it hurts it's swell and its hurts. After receiving vaccine patient went to the doctor, couldn't get a schedule for today, so in two days or so, she make sure and was able to get vaccine again. Since 10 years of age, due to her son marriage with all work she was on her feet like 3 days then had run out at the very last moment and couldn't even dance or walk on her leg and don't remember if it was my right or left but the same thing happened. Swelled her whole ankle got swollen up and couldn't walk for 2 or 3 days. Further stated that all gone away. It was just she couldn't move up her arm at all yesterday." When confirmed that she got the first shot on Sunday, (Later confirmed as 28Mar2021). Patient had swelling only on left side but not right side. When she woke up this morning it look like all her veins were sticking out of arm that say its very weird way to describe the blood in veins (stated she could see her veins through hand, as anyone couldn't see them but see they were right under her skin on both sides in hands and both sides of lower arm actually). She put her legs up and feel may swelling goes down little more, her husband keeps on telling to walk on it but if she walk on it, it swells more. Her weight was 112 yesterday (as reported as probably). Now it was 111. Patient was concerned over the lady at the (name) that gave the Covid 19 vaccine. The lady at (name) didn't even asked what medications she's on. She's not allergic to anything but she was in a car accident a long time ago. For everything to swell up like that was ridiculous. She got the Covid 19 vaccine on the left side and her joints on the left side were terrible. It was only on her left side. She reports the joint pain and swelling is gone and only lasted a couple days. She's supposed to be resting but that's impossible when you have a 10 year old and a 13 year old living with her. All the swelling and joint pain occurred on the left side of her body, nothing on the right side. The same side as she got the Covid 19 vaccine in her left arm. She had to wait until she was eligible for the vaccine when they opened it up for people over 50 years old. Patient weighs 117lbs 3 days ago (as per report), now she weighs 113lbs and that's in clothes. When the patient went for regular physician office visit but she mentioned about the reactions to the vaccine that was pain and swelling in her joints on the left side. Patient did not receive treatments for the events. She was worried about going back and having anaphylactic shock with the second Covid 19 vaccine. She enquired who is going to give her the epi pen if she needs it. Her doctor said if she has any doubts, if she goes into anaphylactic shock, will get an ambulance and told her to expect to have a severe reaction to the second vaccine Covid 19. The reporter assessed the events as non serious. The outcome of the event soreness at the injection site was recovered on 30Mar2021 and the rests of the events was unknown.
57 2021-07-17 swelling face eye lids where swollen; around eyes was burning; skin waspeeling all over face; cheek swelling; This... Read more
eye lids where swollen; around eyes was burning; skin waspeeling all over face; cheek swelling; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old adult non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 23Mar2021 at 09:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus. Concomitant medications included multi vitamin gummies (MANUFACTURER UNKNOWN), B12 gummies (MANUFACTURER UNKNOWN), vitamin D3 gummies (MANUFACTURER UNKNOWN) and vitamin C gummies (MANUFACTURER UNKNOWN) for unknown indication, from an unknown date and unknown if ongoing. The patient was allergic to nickel. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, at 11:00, after 2 hours of receiving the vaccination, the patients lower half of right cheek started to swell. On 24Mar2021, on the next day, both eye lids were swollen and the area under eyes were also swollen, skin around eyes was burning and skin was peeling all over face. Therapeutic measures were taken as the result of adverse events, which include treatment with antihistamines (FENISTIL). The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of burning sensation, cheek swelling, eye lid swelling and skin peel was recovered on an unknown date in Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
57 2021-07-17 swelling face swelling of face and throat; swelling of face and throat; bad rash all over body; numbness on her fa... Read more
swelling of face and throat; swelling of face and throat; bad rash all over body; numbness on her face; allergic reaction from her nose down to her chin; tongue still feels heavy; This is a spontaneous report from a contactable consumer. This 57-year-old female consumer (patient) reported for herself. A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0202, Expiry date: unknown) via an unspecified route of administration in Arm Left on 27Jun2021 14:45 (at the age of 57-years-old) as single dose for covid-19 immunization. Medical history included patient was diagnosed about 10 or 20 years ago for thyroid nodules from an unspecified start date and ongoing. Family medical history includes: Father has high cholesterol, no cancer in her family. Her dad has thyroid conditions. Patient didn't have any other vaccine prior to vaccination (within 4 week) and no adverse event prior vaccination. Concomitant medication included thyroid (ARMOUR THYROID) taken 0.25 one tablet daily for thyroid nodule. Sign of severe allergic reaction include swelling of face and throat, bad rash all over body. Upon follow up on 29Jun2021 patient reported that on 27Jun2021 15:20 patient experienced allergic reaction from her nose down to her chin, her face was numb like she had Novocain. And when patient woke up in morning and recovered (28Jun2021) from numbness in her face but tongue still feels heavy. Patient states she had COVID, and it was not severe and felt like it was not enough to put a vaccine in her body. She felt like with delta strain it may be more severe than the other strain. Patient feel like she was pressured to have it, took it for piece of mind. Patient received treatment for allergic reaction and numbness. The outcome of the event allergic reaction from her nose down to her chin, her face was numb like she had Novocain recovered on 28Jun2021 and tongue still feels heavy unknown. Referred to HCP for further clinical recommendations.
57 2021-07-17 swelling face after 9 hours swollen tongue.; tingling lip; tip of tongue tingling; left side of face swollen; This... Read more
after 9 hours swollen tongue.; tingling lip; tip of tongue tingling; left side of face swollen; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via unspecified route of administration in the left arm on 27Mar2021 at 15:30 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. The patients medical history included high blood pressure, obese. The patient had no known allergies. Concomitant medication included, lisinopril (MANUFACTURER UNKNOWN), unspecified multi vitamins (MANUFACTURER UNKNOWN), ergocalciferol (VITAMIN D), ascorbic acid; rosa canina (VITAMIN C) for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not tested positive for COVID-19. Since the vaccination the patient had not been tested for COVID-19. About 9 hours after shot on 28Mar2021 at 12:30, the patient woke up with swollen tongue and took Dimetapp. Awoke 7 hours later on 28Mar2021 at 07:30 and noted left side of face was swollen and lips and tip of tongue were tingly and took Dimetapp again. Adverse events did not result in Doctor or other healthcare professional office/clinic visit. Therapeutic measures taken for swollen tongue, swollen face, tingly lip and tip of tongue included Dimetapp. The clinical outcome of swollen tongue, swollen face and tingly lips, tongue tip was unknown. No follow-up attempts are needed. No further information is expected.
57 2021-07-17 swelling Left armpit hurts; feels like a golfball size knot; This is a spontaneous report from a contactable ... Read more
Left armpit hurts; feels like a golfball size knot; This is a spontaneous report from a contactable other health care professional, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 27Mar2021 at 12:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had allergy to sulfa drugs. Concomitant medication included sertraline (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 07:00, the patient experienced left armpit hurts and felt like a golf ball size knot. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events armpit hurts and felt like a golf ball size knot were not recovered at the time of this report. Information about lot/batch number cannot be obtained; No follow-up attempts are needed;
57 2021-07-19 oral herpes very sore arm; 48 hr after injection developed PVC's - in/out of geminy for 3 days; generalized fati... Read more
very sore arm; 48 hr after injection developed PVC's - in/out of geminy for 3 days; generalized fatigue which worsened over time with worsening of pvc frequency; Shingles-type nerve pain left trunk; Shingles-type nerve pain left trunk; eruption of herpes in corner of mouth; scalp pain; unifocal pvc's at first, which slowly progressed into more frequent and multifocal pvc's , worsening with any increased activity; unifocal pvc's at first, which slowly progressed into more frequent and multifocal pvc's , worsening with any increased activity; This is a spontaneous report from a contactable Nurse (Patient). A 57yearsold female patient received bnt162b2 (PFIZER BIONTECH COVID19 VACCINE, solution for injection, Lot Number: EL3302, at age of vaccination 57 years), dose 2 via an unspecified route of administration, administered in Arm Left on 10Jan2021 15:00 as dose 2, single for covid19 immunisation. Medical history included Hypothyroidism and allergies (Mild latex, mild food allergies associated with latex). Concomitant medication(s) included levothyroxine, thyroid (ARMOUR THYROID), asa, colecalciferol (VITAMIN D), ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10). Previously patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Dec2020 10:00 AM (Batch/Lot Number: ELO140) as dose 1, single for covid19 immunisation. From first injection patient experienced sore arm for few hrs, fatigued 2 days, felt cold (wore jacket) and x2days (afebrile). The patient did not receive any other vaccine in fourweeks. It was unknown if patient had covid prior vaccination. Patient did not test covid post vaccination. On 12Jan2021at 01:00 PM, the patient experienced very sore arm x 3 days, 48 hr after injection developed PVCs in/out of geminy for 3 days then geminy resolved but remained with what seemed like unifocal pvcs at first, which slowly progressed into more frequent and multifocal pvcs , worsening with any increased activity (ex: walking from parking lot to work place), generalized fatigue which worsened over time with worsening of pvc frequency. Lasted almost exactly 4 months from day of injection (15 weeks). About to request cardiology referral, increased ASA intake to 350 mg bid (was 81 mg qd) (selfprescribed) and pvcs progressively resolved over 4, 5day period then stopped completely. Energy returned. Also, developed scalp pain (abt 10 d, resolved then returned), then developed Shinglestype nerve pain left trunk, and also 2x over that 4 mo. had neareruption of herpes in corner of mouth (in remission x40 yrs). Patient received treatment for the event extrasystoles, and no treatment was taken for other events. The outcome of event scalp pain was recovered with Sequel.The outcome of event very sore arm, 48 hr after injection developed PVCs in/out of geminy for 3 days, unifocal pvcs at first, which slowly progressed into more frequent and multifocal pvcs , worsening with any increased activity was recovered on 15Jan2021. The outcome of the events all others was recovered on unspecified date 2021. No followup attempts are possible. No further information is expected
57 2021-07-19 peripheral swelling I am worried that the vaccine has messed up my immune system and caused my RA to come back; I am wor... Read more
I am worried that the vaccine has messed up my immune system and caused my RA to come back; I am worried that the vaccine has messed up my immune system; My fingers started swelling; The pain and swelling in my hands is now excruciating and it is starting in my feet; My fingers are starting to twist and curl; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 57-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203 and expiration date was not reported), via an unspecified route of administration in arm left on 04Mar2021 at 12:30 as dose 2, single (age at vaccination 57-year-old) for COVID-19 immunisation. Medical history included rheumatoid arthritis from an unknown date, Thyroid Disease from an unknown, Hashimotos from an unknown date. The patient previously took levaquin and experienced hypersensitivity. Historical vaccine information included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number EL9261), via an unspecified route of administration in arm left on 12Feb2021 at 12:15 PM for COVID-19 Immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications within 2 weeks of vaccination includes compounded Thyroid med, compounded est/test cream. The patient reported that worried that the vaccine has messed up her immune system and caused RA to come back, her fingers started swelling, the pain and swelling in her hands was now excruciating and it was starting in her feet, her fingers were starting to twist and curl on 10Apr2021. Patient had RA in the past but had been in remission for over a year and a half. About a month after getting the 2nd COVID vaccination her fingers started swelling and hurting. The pain and swelling in her hands was excruciating and it was starting in her feet. Her fingers were starting to twist and curl. She was worried that the vaccine has messed up her immune system and caused her RA to come back way worse than it ever was. This was coming on fast and very severe. She won't be able to work much longer if something wasn't done to reverse the pain and damage. The patient underwent lab tests and procedures which included x-ray: unknown on an unknown date. Therapeutic measures were taken as a result of events includes medication for the pain and inflammation, x rays. The outcome of the events were not resolved. Follow-up actions are needed. Further information has been requested.
57 2021-07-19 peripheral swelling Patient began to experience pins and needles in upper lip and left cheek within 15 minutes of vaccin... Read more
Patient began to experience pins and needles in upper lip and left cheek within 15 minutes of vaccination. Later that evening her chin, ears, and around her eyes developed hives and were very itchy. She also developed swelling under both arms the following day.
57 2021-07-20 anaphylactic reaction Moderate anaphylaxis, sneezing, very runny nose, coughing, asthmatic episode
57 2021-07-20 peripheral swelling Feet and legs swell and have pain, itch and subcutaneous hemorrhage. Heart rate increases. Heart h... Read more
Feet and legs swell and have pain, itch and subcutaneous hemorrhage. Heart rate increases. Heart has cardiopalmus and sometime feel stopping . The skin color of feet and leg becomes brown.
57 2021-07-20 swelling face goosebumps; chills; chest was completely red; face was swollen a little more; getting panicky; the s... Read more
goosebumps; chills; chest was completely red; face was swollen a little more; getting panicky; the sides of her lips were burning; eyes were swollen a little; her mouth was swollen, on top of her mouth and the sides of her cheeks; there were hives on top of her palate/ getting hives all over; lips were swollen; her legs started itching/she was itching all over her body/ears were itching; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old female patient received an unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265; Expiration Date: May2021), via an unspecified route of administration on 02Feb2021 (at the age of 57-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she had the vaccine on 02Feb2021 (Tuesday) and she didn't felt bad. Then on 04Feb2021 (Thursday) her legs started itching and by 05Feb2021 (Friday) she was itching all over her body and her mouth was swollen, on top of her mouth and the sides of her cheeks, she could feel with her tongue on her palate, there were hives on top of her palate, after that day she was able to eat little by little because every time she would eat, her mouth would swell so she would stop and let it go down and then continue eating. She never felt like her breathing was compromised, she never felt like she could not breath. On 05Feb2021 (Friday) she was worse, so on Friday and Saturday (06Feb2021) she had hives on her body and her mouth was getting even more and her lips were swollen, everything was on the inside of her mouth. On 05Feb2021, she wrote itching down, she left out Saturday 06Feb2021 the top of mouth felt almost like she had hives but there was nothing major as the day progressed the sides of her lips were burning and she as itching all over body she was getting worse but still nothing major. There was nothing major Saturday night. Also 06Feb2021 at 10 pm she was getting worse she got home she was eating her mouth felt like it was itching, her ears were itching when finished dinner, she felt worse her eyes were swollen a little she took 2 Benadryl and by 10:30 she was better and at 10: 30 she fell asleep. On 07Feb2021 at 6:30 the inside of her lips, especially the top one was swollen and her palate was swelling and she read it and called CDC she called someplace else she tried to do that. Then 07Feb2021 (Sunday) she was itching on her body that was getting worse, she was getting hives all over her she went to work and worked until 9 still felt the same. Also, on 07Feb2021 she took pictures of the hives, she tried to eat breakfast. She clarifies she went to work on 07Feb2021 and she was getting panicky so she had to get someone to replace her, her mouth was swollen and by the time she got someone replace her it was like and hour later and she was a little better emotionally but she felt very scared. She takes pictures every day, she felt like that was important. She says she tried to eat breakfast every time she tried to eat her mouth gets more swollen, its her mouth not her throat. She says at 10:30 on 07Feb2021 she felt better with her swelling on her mouth, she was still itchy all over her body. She took 2 Benadryl and 1 Zyrtec. At 10 am she took pictures. She clarifies on 07Feb2021 she arrived home at 10 PM she took 2 Benadryl and Zyrtec, she fell asleep and the itching woke her up at 4:30 AM that would be Monday early AM. She applied Benadryl cream all over her body and she felt asleep, she woke up at 10 am and ate breakfast then felt asleep again. On the 08Feb2021 at 12:32 PM she woke up again and she was worse her chest was completely red and her face was swollen a little more, her itching was worse. She called her doctor she never answers. She took more pictures because it was worse she has written the pictures were taken at 12:30 pm. She has noticed a big difference yesterday and today her mouth was much worse before yesterday and today. On 08Feb2021, she went to the doctor at 4:30 and her doctor gave her an injection of some kind of steroid. No further information provided. She also gave her pack to take of steroids for 6 or 5 days and she prescribed an Epi pen. She said to take Benadryl every 4-6 hours and Zyrtec one time at night. She got up this morning and she was a little better now she was at work and she felt so bad, everything was itching, and she has goosebumps and chills but she has no fever she has not had a fever at all since got the vaccine. She has the packaging for her steroid. It says the name is Methylpred 4 mg pack (NDC 5974600103, lot number 20K0042P, expiration Aug2022). Day quantity 21 she thinks that is what it how many tablets. Outcome of the events her legs started itching/she was itching all over her body/ears were itching, her mouth was swollen, on top of her mouth and the sides of her cheeks, there were hives on top of her palate/ getting hives all over and lips were swollen was not recovered and was unknown for all other events. Follow-up attempts are completed. No further information is expected.
57 2021-07-21 lymph node swelling Armpit pain; Hot to touch; large red looking welt approx 4-5 inches width; swollen lymph nodes armpi... Read more
Armpit pain; Hot to touch; large red looking welt approx 4-5 inches width; swollen lymph nodes armpit; swollen lymph nodes at site of injection; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 31Mar2021 at 10:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient medical history included diabetes. Patient received other medication in 2 weeks which included dulaglutide (TRULICITY) for unknown indication and start date. The patient did not report any allergy to food, medication and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, 16 hours after 2nd vaccine, the patient woke at night with armpit pain, swollen lymph nodes armpit and at site of injection, hot to touch with large red-looking welt approx. 4-5 inches width. Three days later, still swollen at site, warm to touch with welt look and slight expansion of redness area. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/ department or urgent care. The clinical outcomes of the events armpit pain, hot to touch, large red-looking welt approx. 4-5 inches width, swollen lymph nodes armpit, swollen lymph nodes at site of injection were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
57 2021-07-22 lymph node swelling Starting on Feb 1st, I woke up and I had enlarged neck lymph nodes, they continued and still exist. ... Read more
Starting on Feb 1st, I woke up and I had enlarged neck lymph nodes, they continued and still exist. They are chronically enlarged lymph nodes. When I saw Nurse Practitioner, she id a physical exam and advised I would need a neck xray, which did confirm they are enlarged
57 2021-07-22 swollen extremities My left arm, shoulder, under arm, armpit, and breast had a noticeable amount of edema that has not r... Read more
My left arm, shoulder, under arm, armpit, and breast had a noticeable amount of edema that has not resolved. Also by the end of week one my left knee was also swelling. Pain in arm is constant.
57 2021-07-25 lymph node swelling 01/29/2021 Felt lightheaded immediately after vaccine, nauseous, lymph nodes in neck swelled, one un... Read more
01/29/2021 Felt lightheaded immediately after vaccine, nauseous, lymph nodes in neck swelled, one under right arm was very big by bedtime. Fatigue. I had shortness of breath a few hours later. I have a difficult time catching my breaths sometimes too. Bad headache with sharp pain. Still experiencing these symptoms. Memory fog continues to this day. I have been accepted into the COVID clinic and will have my first visit on August 31st. Visited ER. I have also had debilitating widespread body cramps. 03/05/2021 Neck lymph nodes swelled, left and right. Headache was very pronounced but dull. All side effects from vaccine one persist into vaccine two. I continue to be extremely fatigued, I missed work the entire month of January. My neck is so stiff and this is a new side effect that just began with the second vaccine.
57 2021-07-25 peripheral swelling Vaccines were administered. Patient reports upper arm pain in the left upper arm that has been ongoi... Read more
Vaccines were administered. Patient reports upper arm pain in the left upper arm that has been ongoing since getting her first COVID vaccine in March. She states her arm was swollen almost immediately after the first vaccine, she did not report this to anyone. Patient reports pain is worse with lying down, aching and tingling pain, constant pain like needles are sticking in her arm, and hurts when raising her arm up putting on her clothes. She reports no problems after the 2nd vaccine which was given in her right arm. She states that the arm did swell right after the injection but is not sure how long it took for swelling to go down.
57 2021-07-26 swelling face The patient reported a "lupus-like" rash on her face after receiving the vaccine. She described her ... Read more
The patient reported a "lupus-like" rash on her face after receiving the vaccine. She described her face as very red, swollen, puffy, and pimply but not itchy. She also stated that the rash was worse on the left side of her face than the right side. She also stated that she had a sick stomach, diarrhea, and drowsiness on the first day after the vaccine. She stated that she is feeling much better now other than the rash on her face that has not gone away. The patient stated that she had a history of anaphylaxis in the past, but the doctors were never able to determine the cause.
57 2021-07-27 lymph node swelling Swollen, red, hot, painful injection site; Headache; Fever; Fatigue; Chills; Swollen lymph nodes und... Read more
Swollen, red, hot, painful injection site; Headache; Fever; Fatigue; Chills; Swollen lymph nodes under armpit; Swollen, red, hot, painful injection site; Swollen, red, hot, painful injection site; Swollen, red, hot, painful injection site; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 30Mar2021 at 10:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine and COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included topiramate (TOPAMAX), escitalopram oxalate (LEXAPRO) and cetirizine hydrochloride (ZYRTEC); all from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 02:00, the patient experienced swollen, red, hot, painful injection site 2 days post injection 6 cm, headache, fever, chills, swollen lymph nodes under armpit and fatigue. Injection site and lymph node still swollen and painful 6 days after injection. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of swollen, red, hot, painful injection site 2 days post injection 6 cm, headache, fever, chills, swollen lymph nodes under armpit and fatigue and included treatment with 50 mg diphenhydramine (BENADRYL), 800 mg ibuprofen (MANUFACTURER UNKNOWN) and ice. The clinical outcomes of swollen, red, hot, painful injection site 2 days post injection 6 cm, headache, fever, chills, swollen lymph nodes under armpit and fatigue were recovering. No follow-up attempts are needed. No further information is expected.
57 2021-07-27 peripheral swelling Slight itchy feeling underneath skin; Red unraised 2.5 inch circle around theinjection site- red ras... Read more
Slight itchy feeling underneath skin; Red unraised 2.5 inch circle around theinjection site- red rash like; Small raised bump size of nail bed; Arm felt slightly sore; Felt dizzy and lightheaded; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EN6207) via an unspecified route of administration in the right arm on 19Mar2021 at 16:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Concomitant medications included phentermine (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On (19Mar2021), Day 1 of initial injection, arm did not hurt. Day 2 (20Mar2021) experienced small raised bump size of nail bed (arm swelling) and arm felt slightly sore (pain in arm). On day 12 (30Mar2021), unknowingly found red unraised 2.5-inch circle around the injection site, red rash like (vaccination site erythema) slight itchy feeling underneath skin (pruritus). The patient felt dizzy and lightheaded for those 12 days as well. The patient called the 800 and asked if she should report it. She was informed that those were slight side effects that usually went away within 5 days after the shot. She asked if she should report considering it was well after that timeframe and she was informed that she could if she wanted to. She also had picture if needed. She was assuming that she had a slight allergic reaction but was wondering if anyone else had the same thing happened for that length of time. She decided to wait until the day before going to doctor. By then it had disappeared so she did not report it anywhere else. The patient was scheduled for her second dose on 09Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of light headed, arm swelling, pain in arm, vaccination site erythema and pruritus were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
57 2021-07-27 swelling face Head-to-toe itchy rash; Day after shot had swelling of face; This is a spontaneous report from a con... Read more
Head-to-toe itchy rash; Day after shot had swelling of face; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 16Mar2021 at 14:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. The concomitant medication was taken by the patient (unspecified) within two weeks prior to COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 day after the shot, the patient experienced swelling of face and on 23Mar2021 by day seven, the patient experienced head-to-toe itchy rash. The events resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures were taken as a result of events which included treatment with prednisone oral and topical steroid cream from an unspecified date in 2021 and unknown if ongoing. The clinical outcome of the events head-to-toe itchy rash and swelling of face were recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
57 2021-07-28 swelling face Left side of my face became swollen; Itched all over my face and my body was itchy; Incredibly nause... Read more
Left side of my face became swollen; Itched all over my face and my body was itchy; Incredibly nauseous; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 30Mar2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included sjogren's, fibromyalgia, crohn's, osteoarthritis (OA), degenerative disc disease (DDD), hypothyroidism. The patient had known allergies to medications, food or other products. Concomitant medications included oxycodone (MANUFACTURER UNKNOWN), hydroxychloroquine phosphate (PLAQUENIL), febuxostat (ULORIC), baclofen (MANUFACTURER UNKNOWN), potassium chloride (Kcl) (MANUFACTURER UNKNOWN), pregabalin (GABAP); all from an unknown date for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the arm left on 09Mar2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, 3 days after second vaccination, the patient experienced the left side of her face became swollen, itched all over face and body was itchy and was incredibly nauseous. The first two days the patient slept. all day both days. The patient had other meds that patient took that would not fit on section. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of itchy, swollen face and nausea were unknown. No follow-up attempts are needed. No further information is expected.
57 2021-07-29 lymph node swelling Skin rash; swelling of lymph nodes in left armpit (same arm where the injection was received); This ... Read more
Skin rash; swelling of lymph nodes in left armpit (same arm where the injection was received); This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the arm left on 01May2021 at 16:30(at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not received any concomitant medication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 10Apr2021 at 12:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021, the patient experienced skin rash and swelling of lymph nodes in left armpit (same arm where the injection was received by patient). The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events skin rash and swelling of lymph nodes in left armpit was not recovered. No follow-up attempts are needed. No further information is expected.
58 2020-12-31 peripheral swelling Hands turned red with slight swelling. Face and chest with red blotches. Nausea and pounding heart ... Read more
Hands turned red with slight swelling. Face and chest with red blotches. Nausea and pounding heart rate. This is the same symptoms I experience if I drink alcohol. I drank water and it got better in an hour. At night, my scalp was itching all nite. My scalp was red on the right side only which was the site of the vaccine. It is now 2 days later; the itching is gone but scalp has red blotches although they have faded at lot.
58 2021-01-03 lymph node swelling 12/17/2020 VACCINE 12/18/2020 SWOLLEN LYMPHNODES IN GROIN, FATIGUE 12/21/2020 EXPERIENCED A STEMI;... Read more
12/17/2020 VACCINE 12/18/2020 SWOLLEN LYMPHNODES IN GROIN, FATIGUE 12/21/2020 EXPERIENCED A STEMI; RUSHED TO ER; FELT LIKE COULDN'T BREATHE, INCREASED HR CARDIAC CATH
58 2021-01-05 peripheral swelling Swelling of my arm and hand; Swelling of my arm and hand; This is a spontaneous report from a contac... Read more
Swelling of my arm and hand; Swelling of my arm and hand; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EL0140), via an unspecified route of administration, on 30Dec2020 at 04:30 PM (at the age of 58-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the right arm. Medical history included Allergy induced asthma. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included montelukast sodium (SINGULAIR) (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN), estradiol (ESTROGEN) (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Sulfa (MANUFACTURER UNKNOWN) and Keflex (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced allergy. On 31Dec2020, the patient reported "Swelling of my arm and hand." The patient did not receive any treatment for the events. The clinical outcome of the events swelling of my arm and hand was recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
58 2021-01-06 lymph node swelling Sore arm, following day fatigue , swollen lymph node right neck and sore axilla on right side. Third... Read more
Sore arm, following day fatigue , swollen lymph node right neck and sore axilla on right side. Third day, swollen lymph node to left neck lasting several days . Did not prevent me from doing anything.
58 2021-01-07 anaphylactic shock After 4 minutes of vaccine administration (at 10:00am) patient developed respiratory difficulty and ... Read more
After 4 minutes of vaccine administration (at 10:00am) patient developed respiratory difficulty and swallowing problems. A Rapid Response code was activated for an Anaphylactic Shock. One dose of Epinephrine 0.3mg IM and two doses of Benadryl 50mg IV were administrated. Vital Signs at 10:02a.m: BP 197/107mmhg, HR 103bpm and O2 Saturation:99%. Vitals Signs at 10:07a.m: BP 211/110mmhg, HR 110bpm and O2 Saturation:98%. At 10:07a.m patient was transfer to the ER by the Rapid Response team.
58 2021-01-07 lymph node swelling I had a mammogram on 1/6/2021. The mammogram showed that I had inflamed lymph nodes in my left brea... Read more
I had a mammogram on 1/6/2021. The mammogram showed that I had inflamed lymph nodes in my left breast, which is the same side on which I received the injection (left arm). I had an ultrasound the same day. The same radiologist read the mammogram and the ultrasound. There were multiple axillary lymph nodes on the left side.
58 2021-01-07 peripheral swelling Soreness , fatigue , Arm swollen , Sore to the touch .
58 2021-01-10 lymph node swelling, lymph node pain Second COVID immunization from Pfizer at 0930 sat. (No symptoms at all with first immunization) Sym... Read more
Second COVID immunization from Pfizer at 0930 sat. (No symptoms at all with first immunization) Symptoms of fatigue began approx. 12 hrs. late, then fever after midnight, chills, body aches, severe headache, abd cramping, and extreme fatigue. Highest fever recorded was 101.8 the next day (Sunday) around 4pm. Didn't take Tylenol or Motrin. As of writing this (Monday 12:07 pm) my fever is gone but headache and extreme fatigue remain. Injection site still sore and today I notice I have a very swollen and painful lymph node left axilla opposite injection site. I had to call in sick today and possible will tomorrow if the extreme fatigue and headache don't go away.
58 2021-01-11 lymphatic obstruction, oral herpes, lymph node swelling, swelling lymph node swelling and lymphedema in the right forearm side and the right upper arm; lymph node swe... Read more
lymph node swelling and lymphedema in the right forearm side and the right upper arm; lymph node swelling and lymphedema in the right forearm side and the right upper arm; cold blister on lip; significant swelling on the right side of the base of her neck near her clavicles; slightly itchy scalp; redness, swelling, tenderness at injection site; redness, swelling, tenderness at injection site; redness, swelling, tenderness at injection site; This is a spontaneous report from a contactable Registered nurse reporting for herself. A 58-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (Batch/lot number: EL0140), in Hospital, by intramuscular route in right upper arm on 23Dec2020 at 08:30, at 58-year-old of age, at single dose for COVID-19 immunization. The patient had no relevant medical history. She didn't receive any prior vaccinations within 4 weeks. There were no concomitant medications. The patient reported that it has been 2 weeks since she received the COVID-19 Vaccine now and she still has a considerable amount of lymph node swelling and lymphedema in the right forearm side and the right upper arm. The nodes on the right side of her neck around the clavicle have been quite swollen for about 2 weeks. She has the list of side effects so she was not concerned, as this was listed but now she's not sure. When she got the vaccine she had the expected redness, swelling and tenderness at injection site (onset reported as 23Dec2020). On the evening of the 24Dec2020 she had an itchy scalp but she didn't see any rash and that only lasted a short time. On 29Dec2020 the patient had a significant swelling on the right side of the base of her neck near her clavicles that wrapped around to the posterior of her neck and was assessed as medically significant. She treated it by putting ice on it in the evening. On 30Dec2020 the swelling seemed to be slightly decreased but it is still a visible lump, the nodes are firm and there is swelling around those and it has not improved since the 30Dec2020. On 30Dec2020 she noticed a little cold blister or hive on the center of her lower lip and that was resolved by 03Jan2021, she did not have fever and did not feel sick, but her main problem is the swollen lymph nodes around base of neck around clavicle and it is considerably swollen there. The patient reported that last night (06Jan2021) it looked like her right arm was swollen, she thinks she is having lymphedema on the right arm, her right forearm is half an inch circumference larger than her left arm and was measured at her work. The patient reported she is seeing her new primary care doctor on 26Jan2021 and will follow up with the doctor. The patient wanted to know if she should get the second dose scheduled for the next week or should wait until the swelling resolves. Moreover the patient asked how long do the side effects usually last (specifically systemic side effects). The events "redness, swelling and tenderness at injection site" and "slightly itchy scalp" resolved on 25Dec2020, the event "Cold blister on lip" resolved on 03Jan2021. The event "Swelling on the right side of the base of her neck near her clavicles" had not resolved yet at the time of the report. All the reported events were assessed as related to the COVID-19 Vaccine by the Primary Source Reporter (Method of assessment:Agency).; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events swelling and lymphadenopathy cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
58 2021-01-11 peripheral swelling 1//7/2021, day vaccine was administered; within a couple hours I began to experience fatigue, headac... Read more
1//7/2021, day vaccine was administered; within a couple hours I began to experience fatigue, headache and R arm pain where vaccine was given.1000 mgs. Tylenol was taken, which offered very little relief. 1/8/2021; I awoke with extreme fatigue, unable to sit up, nausea, and diarrhea with stomach pain, headache, which wasn't unrelieved by 1000mgs of Tylenol, unable to raise R arm due to swelling and pain, aching and weakness all over body, joints, and muscles. It also caused a Fibromyalgia flare-up, which I wasn't experiencing prior to vaccine. It was 1/10/2021 before I was starting to feel better.
58 2021-01-12 anaphylactic reaction Systemic: Anaphylaxis-Severe
58 2021-01-14 lymph node swelling, lymph node pain Patient is concerned about lymph nodes, says that they developed under her arm as swollen and tender... Read more
Patient is concerned about lymph nodes, says that they developed under her arm as swollen and tender. Slight fatigue
58 2021-01-15 lymph node swelling, swollen extremities Axilla swelling, Reactive lymphadenopathy
58 2021-01-15 oral herpes Fever chills aching and nausea and diarrhea and fever blister
58 2021-01-15 peripheral swelling The patient received the vaccine and went to sit for a 15 minute rest period. 5-10 minutes after she... Read more
The patient received the vaccine and went to sit for a 15 minute rest period. 5-10 minutes after she sat down, she stated she had swollen fingers and hands, and felt chest tightness. She was then transported to the ED in a wheelchair.
58 2021-01-18 peripheral swelling Finger tips on right hand tingling and painful. Slightly inflamed and swollen. Just monitored for im... Read more
Finger tips on right hand tingling and painful. Slightly inflamed and swollen. Just monitored for improvement.
58 2021-01-19 lymph node pain, swelling Left Axcillary pain and swelling with, moderate lymph node tenderness. Pain Grade 7/10. Discomfort d... Read more
Left Axcillary pain and swelling with, moderate lymph node tenderness. Pain Grade 7/10. Discomfort developed during the late night following injection.
58 2021-01-19 lymph node swelling Swollen lymph node in area of left collar bone and lower neck
58 2021-01-20 lymph node swelling DEVELOPED LUMP IN RIGHT ARMPIT AND PAIN IN RIGHT ARM MORNING AFTER INJECTION
58 2021-01-20 swelling, swelling face I had the shot in my left arm. Stayed for about 10 minutes and headed out. I told my coworker my ton... Read more
I had the shot in my left arm. Stayed for about 10 minutes and headed out. I told my coworker my tongue felt like it was a little swollen. A little later on I felt like something was on my neck so I reached up felt some swelling on my lower neck and shoulder. Before reaching back to work my face felt like it was swelling only on the left side. As the day went by the workers at my school could tell that my face was swelling. Got home called the hospital and the told me to go to the ER. I went and they checked me out and put me on prednisone and benadryl. Second day I still feel like my face feels numb and still have to swelling at the bottom of my neck.
58 2021-01-21 peripheral swelling Pt. developed itching of her upper palate almost immediately after the vaccine, transiently dizzy bu... Read more
Pt. developed itching of her upper palate almost immediately after the vaccine, transiently dizzy but that resolved quickly . Over the next few minutes she also developed erythroderma of bilateral forearms and hands, slight swelling of hands, reddened palms. We assessed her vital signs below, kept her in observation over the next 40 minutes. She denied difficulty breathing, she questioned if her voice was different, but was not detectable to 2 observors. Lungs remained clear, no stridor, no capillary refill delay. Gradually symptoms improved, erythroderma and hand swelling resolved over about 15 minutes. Pt. then noted possible tongue swelling, on the sides at 25 minutes post vaccine but again, no difficulty with breathing or swallowing. Vital signs continued to improve, pt. then stated itching was gone and tongue felt better so she was released and advised to return to E.R. in event of change. Pt. is a phyician.
58 2021-01-21 swelling face Post-Vaccination Paresthesia course: About Sunday, 1/17/2021, I began to feel a numbing sensation s... Read more
Post-Vaccination Paresthesia course: About Sunday, 1/17/2021, I began to feel a numbing sensation spreading on the top of my head. Since I was recovering from a severe allergic reaction to the Covid vaccine (numb, swollen lips, face, tongue), I initially thought it may be a recurrence. However, by the morning of Tuesday, 1/19/2021, the numbness was complete from the tops of my eyebrows, over my scalp, my ears and down the center of my back to my buttocks. The numbness was bilateral. Alarmed, I went to the Emergency Room. (I am a hospital pharmacist there.) The ER consulted Neurologist. After MRI results, diagnosis was Post-Vaccination Paresthesia. I was released from work by the ER through 1/21/2021. The height of the paresthesia was 1/21/2021. This included some auditory buzzing and mild blurred vision. Today, 1/22/2021, I am beginning to regain feeling on my back and forehead. I estimate that I have regained about 50% feeling on my scalp.
58 2021-01-22 lymph node swelling Extremely enlarged lymph nodes on same side of injection. Supraclavicular. Still present two weeks l... Read more
Extremely enlarged lymph nodes on same side of injection. Supraclavicular. Still present two weeks later but smaller in size
58 2021-01-24 peripheral swelling Right arm noted yesterday to be swollen, warm reddened and purple employee states seem to be getting... Read more
Right arm noted yesterday to be swollen, warm reddened and purple employee states seem to be getting worse. m Vaccinated on Friday
58 2021-01-25 swollen extremities Flu like symptoms, swollen armpit and shoulder pain. Treatment take Tylenol and ice the area. Curren... Read more
Flu like symptoms, swollen armpit and shoulder pain. Treatment take Tylenol and ice the area. Currently still having symptoms.
58 2021-01-26 lymph node swelling Large uncomfortable lymphadenopathy in L neck/clavicle area, the size of a lemon. It hurt to move m... Read more
Large uncomfortable lymphadenopathy in L neck/clavicle area, the size of a lemon. It hurt to move my neck, and is very tender to touch. It is still present now, 10 days after receiving the vaccination. I saw my MD today who assured me it is a typical appearance for a lymphadenopathy, but it still bothers me, especially never having had such an occurrence before.
58 2021-01-27 c-reactive protein increased Fever starting 15 hours after vaccination and continuing for three weeks and still having fever to 1... Read more
Fever starting 15 hours after vaccination and continuing for three weeks and still having fever to 102
58 2021-01-28 lymph node swelling Arm pain at injection sight 6 hours later along with swollen glands. Four days later a migraine hit... Read more
Arm pain at injection sight 6 hours later along with swollen glands. Four days later a migraine hit around 2:00 pm and lasted at least 12 hours. Also swollen shoulders and shoulder and back pain. The following week I experienced sudden shortness of breath that last for approximately 10 minutes while I was at work with profuse sweating on my lower back. The shortness of breath occurred agin the next day while working around the home. and lasted about 5 minutes.
58 2021-01-31 lymph node swelling Jan 31, 430 pm - Red splotches front part of neck, chest, shoulders. A red welt above Left clavic... Read more
Jan 31, 430 pm - Red splotches front part of neck, chest, shoulders. A red welt above Left clavicle, did not itch, but burning sensation. Small node swelling in the clavicle space. Asthmatic flare in the evening and at midnite. Feb 1 - Less redness on skin, but, welt still present. Having chest tightness in the morning and continues as of this report.
58 2021-01-31 lymph node swelling Pfizer-BioNTech COVID-19 Vaccine Low grade fever, chills, body ache, swollen lymph nodes, headache,... Read more
Pfizer-BioNTech COVID-19 Vaccine Low grade fever, chills, body ache, swollen lymph nodes, headache, tired, upset stomach and blisters on my tongue
58 2021-01-31 swelling face Face swelling, fever, vomiting muscle and joint pain. I also have what looks like hives on my eyelid... Read more
Face swelling, fever, vomiting muscle and joint pain. I also have what looks like hives on my eyelid. I?ll still achy.
58 2021-02-04 lymph node swelling, lymph node pain Developed Shingles lesions on my right lower leg. Blisters/vesicles. I noticed this at 1:00am Thur... Read more
Developed Shingles lesions on my right lower leg. Blisters/vesicles. I noticed this at 1:00am Thursday, February 4, 2021. Went to my local Urgent Care facility on Thursday , 2/4/21 morning, 9:20am. Diagnosed with Shingles. Prescribed Valacyclovir 1gm BID. Started first dose on Thursday, 2/4/21 at approx. 10:45am. Currently experiencing burning sensation in the area of lesions. Swollen lymph node in right groin area with pain/ache feeling surrounding the right groin lymph node.
58 2021-02-04 peripheral swelling 2/1 awakened with multiple fingers swollen and painful middle joints only. Sausage fingers. This inc... Read more
2/1 awakened with multiple fingers swollen and painful middle joints only. Sausage fingers. This increased in severity I took nsaids topical steroids Saw rheumatologist who ordered prednisone snd multiple lab tests. Suspect autoimmune reaction triggered by vaccine in some way. Also have migraine
58 2021-02-07 peripheral swelling, swelling Edema / swelling from chest down to feet. 1st day after vaccine I noticed some swelling in my fee... Read more
Edema / swelling from chest down to feet. 1st day after vaccine I noticed some swelling in my feet, 2nd day after vaccine I had 2+ edema in my legs & feet, 3rd day after vaccine I had 3+ pitting edema in my feet and swelling from my chest/abd down to my feet. I initially did not contribute this to the Covid vaccine but thought I was having complications from my surgery. However, I had not had any adverse reactions from my surgery and I had been going to follow up visits weekly with the surgeon. I went to the ER on 1/24/21 because I had gained 13 lbs. in fluid over a 3 day period and thought it could be a DVT or CHF.
58 2021-02-07 swelling Itchy, swollen skin around eyes, face, ears, neck, under left breast, and arms.
58 2021-02-08 lymph node pain, lymph node swelling Starting day 5: extremely painful and inflamed lymph nodes, particularly under arms. Day 9: develop... Read more
Starting day 5: extremely painful and inflamed lymph nodes, particularly under arms. Day 9: developed Cellulitis in left upper arm at injection site
58 2021-02-09 lymph node swelling After about 4 hours, I developed a large swelling of about the size of a goose egg under my right ar... Read more
After about 4 hours, I developed a large swelling of about the size of a goose egg under my right arm pit on the lymph node. The swelling was painful. I went in to see my doctor the next afternoon at 3:20 p,m, and the swelling had shrunk in half. Soft and moveable. No fever or rash or muscle aches other than the pain of the lump.
58 2021-02-09 peripheral swelling Chills; Muscle and joint ache; Muscle and joint ache; Headache; Injection site pain; Tingling; Numbn... Read more
Chills; Muscle and joint ache; Muscle and joint ache; Headache; Injection site pain; Tingling; Numbness; Muscle weakness; Swelling and pain in left arm; Swelling and pain in left arm - all the way down to hand; Swelling and pain in left arm - all the way down to hand; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL3248) at single dose, in the left arm, on 21Jan2021, at 11:45 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Relevant medical history included allergies to sulfa drugs and to wasps, fibromyalgia (autoimmune issues), rosacea, rheumatoid arthritis (RA) and frozen shoulder (L). Concomitant medications, received within 2 weeks of vaccination, included cannabidiol (CBD OIL), vitamin D (ergocalciferol), biotin and meloxicam (MEL). On 21Jan2021, at 03:00 PM, the patient experienced chills, muscle and joint aches, headache, injection site pain, tingling and numbness, muscle weakness, swelling and pain in left arm - all the way down to hand. No treatment was received. The patient did not recover from the events at time of this report. The case was assessed as non-serious (seriousness criteria-results in death: no, seriousness criteria-life threatening: no, seriousness criteria-caused/prolonged hospitalization: no, seriousness criteria-disabling/incapacitating: no and seriousness criteria-congenital anomaly/birth defect: no). Post the vaccination, the patient has not been tested for COVID-19.
58 2021-02-10 axillary mass Chills lump/soreness in armpit of the arm for the vaccine extreme lower back pain....3 days
58 2021-02-10 lymph node swelling Sore throat, headache, cough, neck pain times 2 days. Stated she was fine the first day, second and ... Read more
Sore throat, headache, cough, neck pain times 2 days. Stated she was fine the first day, second and third day she developed flu like symptoms. On day five, she developed lymph node swelling, severe headache rated 10/10, stated pain is radiating up from ther neck causing her not to be able to turn neck. Temperature 102.3, BP 151/103
58 2021-02-11 swelling face facial/ tongue swelling, hives, shortness of breath, trouble swallowing
58 2021-02-14 axillary mass Developed a lump in left axilla(lymph node?) about golf ball sized. Lasted about 24 hours before beg... Read more
Developed a lump in left axilla(lymph node?) about golf ball sized. Lasted about 24 hours before began to resolve. Over next 48 hours resolved completely. Extreme discomfort!
58 2021-02-16 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe
58 2021-02-16 lymph node swelling bad swollen lymph node under right arm pit injection swelling low fever really bad chills headache ... Read more
bad swollen lymph node under right arm pit injection swelling low fever really bad chills headache injection pain tired cough cold low fever pain
58 2021-02-16 swelling On 1/13/21 my 2nd injection I was fine the next day I felt fine but in the afternoon around 2:30 I n... Read more
On 1/13/21 my 2nd injection I was fine the next day I felt fine but in the afternoon around 2:30 I noticed my left side of my neck was swollen so I had asked 2of the M.D.'s and a N.P. to check it and they felt 2 lumps along with the swelling and asked me to keep a eye on it, After a few days the swelling in my neck was gone but the lumps were still there so they asked me to contact my PCP which I did and a few days later she ordered a ultra sound which I had done on 2/4/21 and the results showed there were 3 lumps. I was asked by my PCP to wait 2-3weeks to see if they subside and if not she will order a new ultra sound(which I am waiting to hear back from her)
58 2021-02-18 lymph node swelling Everything was good the first day. The next morning, I had severe chills that lasted about 6 hours. ... Read more
Everything was good the first day. The next morning, I had severe chills that lasted about 6 hours. During that time, I started getting a temp, the highest was 103.3. I called my doctor and she seemed convinced that it was something else because she hadn't seen that reaction before. I then had developed a headache. The fever took several days to go away. My doctor (via phone) told me to take Tylenol. I also had tingling in my right hand, extreme fatigue, joint stiffness and swollen lymph nodes, which remained swollen for at least a week. I was in bed for over 24 hours. It eventually started it get better after a few days. I also had an antibodies test before I got the vaccine and two days later I found out I had positive antibodies--and this was 6 months later (I had COVID in July). I had the same reaction with Dose 2.
58 2021-02-20 lymph node pain, lymph node swelling One hour after injection I experienced pain on the right side of my face. My preauricular lymph nod... Read more
One hour after injection I experienced pain on the right side of my face. My preauricular lymph node is painful and swollen two days after the second Covid vaccine.
58 2021-02-23 peripheral swelling Left upper extremity DVT and pulmonary embolism diagnosed 2/24/2021. Arm swelling started 02/23/2021... Read more
Left upper extremity DVT and pulmonary embolism diagnosed 2/24/2021. Arm swelling started 02/23/2021.
58 2021-02-26 pancreatitis Idiosynchratic Pancreatitis Started to feel radiating severe pain in my back that accompanied severe... Read more
Idiosynchratic Pancreatitis Started to feel radiating severe pain in my back that accompanied severe bloating and pain in the stomach area. Tried Gas-x, pain meds, mineral water. Went into the emergency room at MCR at 3 am. Received blood work, ultrasound and a CT scan. The results were the Pancreatitis. I was sent home with Zophran, and hydrocodone and instructions to be on a clear liquid diet for 48 hours. Released from the ER around7:30 am on Feb 27, 2021
58 2021-02-28 lymph node swelling 24 hours after the 2nd injection I experienced the following: Slight soreness at sight Low grade fe... Read more
24 hours after the 2nd injection I experienced the following: Slight soreness at sight Low grade fever 101 Extreme fatigue Brain fog - or difficulty focusing on work related tasks These symptoms resolved within 24 hours, 3 days after the 2nd injection I developed a lemon sized nodule in my arm pit that was mildly painful to touch. This resolved within 3 days.
58 2021-02-28 lymph node swelling Large painful Lymphadenopathy on L side of neck near clavicle, the size of a lemon; This is a sponta... Read more
Large painful Lymphadenopathy on L side of neck near clavicle, the size of a lemon; This is a spontaneous report from a contactable other healthcare professional (the patient). A non-pregnant 58-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231), intramuscular in the left arm, on 17Jan2021 at 08:30 AM (at the age of 58 years) as a single dose for COVID-19 immunization. Medical history included high cholesterol. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included estradiol (ESTROGEN), pravastatin. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 12:00 PM, the patient developed large painful lymphadenopathy on the left side of neck near clavicle, the size of a lemon. The event was reported as non-serious. Therapeutic measures were taken as a result of large painful lymphadenopathy on left side of neck near clavicle, the size of a lemon. The clinical outcome of the large painful lymphadenopathy on the left side of neck near clavicle, the size of a lemon was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
58 2021-03-01 lymph node swelling Broke out it a hot rash the first night. Both my knees exhibited excruciating pain to where it fel... Read more
Broke out it a hot rash the first night. Both my knees exhibited excruciating pain to where it felt I was having knee surgery without anthesis nothing helped with the pain. General aches through out whole body settling in the joints. Fatigue, migraine headache, loss of smell on and off through day. Loss of appetite on and off. Injection site has a large redden area warm to touch approximate size of a silver dollar if not bigger, lymph node under left arm pit is swollen and sensitive to the touch, movement aggravates the arm pit. Evening time body breaks down in an allergic rash.
58 2021-03-02 peripheral swelling lip swelling 3 times the normal size, skin peeling to right forearm, both hands itching, swelling of... Read more
lip swelling 3 times the normal size, skin peeling to right forearm, both hands itching, swelling of both hands. unable to grasp with both hands, dark spot in middle of hand.
58 2021-03-03 lymph node pain Right Under arm Lymph node and right breast discomfort/ pain
58 2021-03-04 swelling face Patient developed urticarial rash and some facial swelling. She took oral antihistamines with relief... Read more
Patient developed urticarial rash and some facial swelling. She took oral antihistamines with relief. She was given cetirizine to take after she was examined the day following her vaccine.
58 2021-03-10 lymph node swelling, lymph node pain After a few days past the first dose, I noticed a pain on the left side of my chest near my armpit. ... Read more
After a few days past the first dose, I noticed a pain on the left side of my chest near my armpit. Through palpation my primary care dr noticed a large swelling which was very painful when she pressed down on it. She sent me for a diagnostic mammogram which was completed with no issue noted by the radiologist. The technician mentioned that the vaccine has caused lymph node swelling in some women. After about 1.5 more weeks the pain went away.
58 2021-03-11 lymph node pain painful lympnoes
58 2021-03-12 lymph node swelling Fever, headache, fatigue and swelling in armpit about size of ping pong ball
58 2021-03-14 lymph node swelling Migraine headache, severe body ache pain, runny nose, swollen glands in the neck, arms, legs, feet, ... Read more
Migraine headache, severe body ache pain, runny nose, swollen glands in the neck, arms, legs, feet, and hand swelling.
58 2021-03-14 swelling face I have a history of acute and delayed allergic reactions to food and drugs. I received Pfizer vacc... Read more
I have a history of acute and delayed allergic reactions to food and drugs. I received Pfizer vaccine at approx. 12:00 Noon on 13MAR2021. I experienced minor lower lip swelling at 9:30 PM (the lower lip, left side only). Went to bed approx. 10:30 PM and experienced mild chills. I woke up at ~3:30 AM with full facial swelling (forehead, brow, eyes, under eyes, facial lines, jowls and full lower lip only - now right side engaged and more pronounced than the left side) and mild full body hives. I took a Zyrtec. The itching of hives subsided in approx. 30 minutes. The facial swelling and lower lip swelling subsided in approx. 12-hours. I took and have photos of my face and lips.
58 2021-03-15 lymph node pain, lymph node swelling The adverse event occurred the next morning when the pain from the injection sight on the left upper... Read more
The adverse event occurred the next morning when the pain from the injection sight on the left upper arm felt like it moved into my armpit and left side lymph nodes. Very painful accompanied it. The day after that the lymph nodes in my left collarbone area became swollen and painful with an increased fever, chills, headache that lasted for a week. I got the vaccine on a Thursday (3/4/21) and went to my doctor on Monday (3/8/21) to get checked out. This was only my first vaccine. I had a bad case of Covid-19 in June-July 2020 and my husband passed from Covid-19 at that time. I still have swelling in my left collarbone lymph nodes today.
58 2021-03-16 peripheral swelling swollen fingers; joint started hurting; cannot hold fine item; My both hand fingers were drum sticks... Read more
swollen fingers; joint started hurting; cannot hold fine item; My both hand fingers were drum sticks painful/Fingers hurting, I am cutting and dropping things more frequently; This is a spontaneous report from a contactable nurse (patient). A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EN9899) intramuscularly in the left arm on 26Dec2020 at 08:30 (at the age of 58-years-old) as a single dose for COVID-19 immunization. Medical history included migraine from an unspecified date and unspecified if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications ("other medications in two weeks") were reported as none. The patient previously received epinephrine on an unspecified date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 06:00 the patient experienced swollen fingers, joint started hurting, cannot hold fine item and my both hand fingers were drum sticks painful/fingers hurting, I am cutting and dropping things more frequently. The events all resulted in doctor visits and were all serious for disability or permanent damage. The clinical course was reported as follows: "I developed swollen fingers, joint started hurting. My both hand fingers were drum sticks painful (as reported). I had no idea what was going on, things getting my ankle knees (as reported). I consulted internal medicine; I was referred to Rheumatology Clinic. All blood work was negative. All serology testing done was negative. Joints hurting. The doctor asked me to start taking Motrin which made my situation worse. I gave up. Miserable situation. I consulted another FPC who advised I give it time. I cannot hold fine item. Fingers hurting, I am cutting and dropping things more frequently. I am a healthy person. No medication. No complications." The patient asked if there were any solutions. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EN9231) intramuscularly in the left arm on 15Jan2021 (at the age of 58-years-old) as a single dose for COVID-19 immunization. The patient received treatment for the adverse events which included Ibuprofen 400mg for pain. The clinical outcomes of the events swollen fingers, joint started hurting, cannot hold fine item and my both hand fingers were drum sticks painful/fingers hurting, I am cutting and dropping things more frequently were all not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
58 2021-03-16 swelling Swelling, pain, burning sensations under skin, sore/tight muscles, headache, nausea, irritability, t... Read more
Swelling, pain, burning sensations under skin, sore/tight muscles, headache, nausea, irritability, tired
58 2021-03-17 lymph node pain, lymph node swelling Headache, Fever, INJECTION SITE PAIN, SWOLLEN LYMPH NODE (GROIN)/TENDERNESS Narrative: Other ... Read more
Headache, Fever, INJECTION SITE PAIN, SWOLLEN LYMPH NODE (GROIN)/TENDERNESS Narrative: Other Relevant History:
58 2021-03-17 lymph node swelling Dizziness, Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, INJECTION SITE PAIN, SWOLLEN GLA... Read more
Dizziness, Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, INJECTION SITE PAIN, SWOLLEN GLANDS, MALAISE Narrative: Other Relevant History:
58 2021-03-18 axillary mass, lymph node swelling arm sore to touch; swollen/puffed up underneath her arm, thinks is a swollen lymph node; swollen/pu... Read more
arm sore to touch; swollen/puffed up underneath her arm, thinks is a swollen lymph node; swollen/puffed up underneath her arm, thinks is a swollen lymph node; Itchy; restless; seems like she has a rash in her upper chest neck area, neckline; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EK9231) via an Intramuscular route of administration on 27Jan2021 at single dose on left arm for covid-19 immunization. The patient medical history included allergies. The patient concomitant medications were not reported. On 27Jan2021, in evening patient was really restless that night because she was itchy. Physician stated that patient has been experiencing some itching, but it seems like she has a rash in her upper chest neck area, neckline. The itching/rash has stayed the same so far. On 28Jan2021, next day morning It was really sore to touch, like when patient was putting deodorant on, its all puffed out underneath her arm that she had the vaccine administer in. It's swollen, but patient thinks its her lymph node. It doesn't feel like its effected any other one, but just that one lymph node. The outcome of the event Itchy, rash was not recovered while outcome of rest all events was unknown.
58 2021-03-18 lymph node swelling The next day after vaccine chills, vomiting and swollen lymph nodes of left armpit
58 2021-03-18 peripheral swelling I had a sebaceous cyst on my left ring finger it was a big bump but later that night it was gone
58 2021-03-18 swelling face hives, itching, facial swelling. woke up next morning after vaccine with just one or two hives, prog... Read more
hives, itching, facial swelling. woke up next morning after vaccine with just one or two hives, progressed by evening of that day, lips swelled and were numb feeling, felt like a lump in my throat, throat felt swollen but no pain or difficulty breathing. Took 2 Benadyl(generic) at 9:30pm and again at 3:30am
58 2021-03-19 swelling face Fever 102.7, chills, swollen face, feeling unwell, muscle pain, headache, pain
58 2021-03-20 lymph node swelling Sore swollen lymph nodes in my underarm left side. Swollen sore lymph nodes groin both sides; This i... Read more
Sore swollen lymph nodes in my underarm left side. Swollen sore lymph nodes groin both sides; This is a spontaneous report from a contactable Other-HCP (patient). A 58-year-old female started to receive dose of first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: Ek573), via an unspecified route of administration on 11Jan2021 3:30 Pm in left arm, dose number: 1 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: En5318) on left arm, dose number: 2, on 02 Feb 2021 as single dose. The patient medical history included allergies to Penicillin. The concomitant medications included Estrogen (ESTRADIOL), medroxyprogesterone, venlafaxine, alpraz (ALPRAZOLAM) at an unspecified date at an unknown dose. The patient experienced Sore swollen lymph nodes in her underarm left side. Swollen sore lymph nodes groin both sides on 03Feb2021, 05:00 AM. The outcome of events was recovered.
58 2021-03-20 swelling face Severe red rash and swelling on right side of the of my face/Spreading gradually to other areas of m... Read more
Severe red rash and swelling on right side of the of my face/Spreading gradually to other areas of my face and scalp; Severe red rash and swelling on right side of the of my face; extremely tender and hot to the touch/ very painful; Extremely tender and hot to the touch; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265), via an unspecified route of administration in left arm at the age of 58-years (non-pregnant at the time of vaccination), on 10Feb2021 at 08:30 AM at single dose (dose number: 1) for COVID-19 immunization. The patient's medical history included alopecia areata and allergy to Xatham gum. Concomitant medication included valsartan at 160 mg. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. It was reported that on 10Feb2021 at 03:00 PM, "severe red rash and swelling on right side of my face. Extremely tender and hot to the touch. Spreading gradually to other areas of my face and scalp. Very painful". The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received diphenhydramine (BENADRYL) and 20 mg prednisone for 5 days and paracetamol (TYLENOL) as treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
58 2021-03-21 axillary mass About 9 hours after injection, the site started to ooze clear liquid. A perfect small circle of skin... Read more
About 9 hours after injection, the site started to ooze clear liquid. A perfect small circle of skin appeared to be burned off. I cleaned it. Next morning still oozing. Now it is scabbing over day on day 3 Armpit feels like I have a golfball in it.
58 2021-03-21 bursitis Shoulder hurt after shot and continued. Saw doctor on the 19th and was diagnosed with bursitis. No... Read more
Shoulder hurt after shot and continued. Saw doctor on the 19th and was diagnosed with bursitis. No symptoms before the vaccine.
58 2021-03-21 lymph node pain I woke up Sunday morning (about 40 hours after the vaccine) with pain in my shoulders, clavicle, col... Read more
I woke up Sunday morning (about 40 hours after the vaccine) with pain in my shoulders, clavicle, collarbone - also had pressure on collarbone, sensitive to touch, and some cough. Pressure and cough have subsided this morning , pain is still present. It hurts once in a while when swallowing and neck area I checked the lymph nodes at hurt some (I examined my neck like a doctor would to feel for possible swollen lymph nodes but can't tell if they are swollen or not). I put "no" under recovered because the pain is still there.
58 2021-03-24 peripheral swelling Rash all over body, body aches, teeth hurting Right leg numbness tingling swelling pain From day ... Read more
Rash all over body, body aches, teeth hurting Right leg numbness tingling swelling pain From day one
58 2021-03-24 swelling face, anaphylactic reaction 58 Y female here for concern of allergic reaction due to covid vaccine. Received second dose of pfiz... Read more
58 Y female here for concern of allergic reaction due to covid vaccine. Received second dose of pfizer vaccine yesterday. Today awoke feeling funny, felt some tightness in throat, trouble swallowing, more sob, palpitations, headache. When she arrived at work this morning, started dry heaving very nauseated and had to go home. Driving home, she saw her face and noticed it was swollen. No prior hx of allergic reactions. No other new meds or foods in that time. No chest pain. 58F with likely allergic reaction anaphlyaxis to pfizer vaccine. No severe facial swelling, tongue swelling, wheezing but symptomatically concerning given throat tightness, subjective facial swelling (I did see some mild periorbital edema but unable to observe other differences but she could). Not on any ace inhibitor. Less likely chf, acs, pna/ ptx, asthma Pt symptomatically improved a lot after epi, benadryl Observed and deemed stable Dc with prednisone and pepcid
58 2021-03-25 swelling, swelling face 58 y/o F with history of drug allergy (anaphylaxis from penicillin, facial swelling/diarrhea from do... Read more
58 y/o F with history of drug allergy (anaphylaxis from penicillin, facial swelling/diarrhea from doxycycline), seasonal allergy, mild intermittent seasonal asthma developed facial angioedema, erythematous, non-pruritic macules on her face/chest, and a "tiny bit" of chest tightness 5 hours after Pfizer vaccine. Responded to benadryl. 24 hours later facial swelling returned. On 3rd day after vaccination, swelling had fully resolved. No history of dermal fillers. No history of miralax use. Has tolerated influenza vaccine. No recent other vaccines. Skin testing to miralax, methylprednisolone and triamcinolone was negative. I advised her to avoid second dose of Pfizer vaccine.
58 2021-03-25 lymph node swelling Headache. 18 hours after shot to 35 hours after shot. Went to bed for 11 hours. Overall achiness. 1... Read more
Headache. 18 hours after shot to 35 hours after shot. Went to bed for 11 hours. Overall achiness. 18 hours after shot to 35 hours after shot. Went to bed for 11 hours. Axillary lymphadenopathy. 36 hours after shot and continuing. No treatment.
58 2021-03-25 peripheral swelling Headache, Congestion, Stuffy nose, Ear ache, Left Auxilia Swollen - Can not bring arm down Pain on l... Read more
Headache, Congestion, Stuffy nose, Ear ache, Left Auxilia Swollen - Can not bring arm down Pain on left arm injection site
58 2021-03-25 peripheral swelling Arm still sore,. dizzy, feet and ankles swollen, stomach hurts, all my muscles hurt,. headac... Read more
Arm still sore,. dizzy, feet and ankles swollen, stomach hurts, all my muscles hurt,. headache,. nausea,. feel tired no energy
58 2021-03-27 swelling Hives, swelling, itching started at 10:15am.
58 2021-03-28 swelling face Patient is spanish speaker only, 10 minutes post vaccination, lower lip became numb, eyelid and chee... Read more
Patient is spanish speaker only, 10 minutes post vaccination, lower lip became numb, eyelid and cheeks were swollen, syncope, dysphagia occurred. As of today, only has numbness in lower lip. Recommended for her to see provider right away. Patient says she does not have insurance. Recommended some income based clinics but call was disconnected, called back but no answer.
58 2021-03-29 lymph node swelling Developed cellulitis in left arm; Knots in arm where there was pain; Knots in arm where there was pa... Read more
Developed cellulitis in left arm; Knots in arm where there was pain; Knots in arm where there was pain/ Large golf ball size nodule on collar bone (lymph gland?); Fever 101 for 3 days; Headache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number: FN6198 or EN6198 and Expiration date were not provided) on 02Mar2021 15:15 via unspecified route of administration in left arm at SINGLE DOSE for COVID-19 immunization. The patient's medical history included stage 4 metastatic breast cancer, allergies to Penicillin and Cephalexin. The patient's concomitant medications included palbociclib (IBRANCE), letrozole and cetirizine hydrochloride (ZYRTEC). On 07Mar2021, the patient experienced cellulitis in left arm, painful spots in arm as if a bruise but not bruised but knots in arm where there was pain, bright red in left arm and felt hot from elbow to hand, severe swelling of left arm from elbow to hand, peeling of skin on left forearm, large golf ball size nodule on collar bone (lymph gland), fever 101 for 3 days and headache. The patient visited doctor or other healthcare professional office due to events and treated with antibiotics. The patient did not take other vaccine in four weeks. The patient did not have Covid prior to vaccination and not tested post vaccination. At time of report, the patient was recovering from all the events. Information on the lot/batch number has been requested.
58 2021-03-30 lymph node pain Extremely painful lymph node behind right ear.
58 2021-03-30 peripheral swelling Extreme pain in left side of back below ribs, prescribed a pain medication Myalgia swelling in feet ... Read more
Extreme pain in left side of back below ribs, prescribed a pain medication Myalgia swelling in feet and legs bleeding in left eye conjunctiva hemorrhage I was tested by blood urine and CT of Aorta and nothing was found to be the cause of the pain or bleeding except the blood pressure was elevated. I told Doctor I had the covid shot and began experiencing the symptoms the next day. I took all my medications and did not have a problem with the pressure. She could find no physical outside of covid cause and sent me home the next morning.Symptoms began 3/27/21 and I was in the ER by 6pm on 3/29/21 and stayed until 3/30/21.
58 2021-03-30 swelling face allergic reaction to the first dose; Felt like her throat was constricting; Very flustered while dri... Read more
allergic reaction to the first dose; Felt like her throat was constricting; Very flustered while driving home, somehow missed her exit; face is swollen; fast heartbeat; heart racing really fast; This is a spontaneous repot from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199), intramuscular in the muscle of upper left arm (deltoid left) on 03Mar2021 17:15 at a single dose for COVID-19 immunization. The vaccine was administered at a pharmacy, not a facility. No other vaccines were administered on same date of BNT162B2. The patient did not receive any other vaccines within 4 weeks prior to receiving BNT162B2. Medical history included hormone replacement therapy, high blood pressure, and "very sick she guessed from a cold and had asthma" on 2011 (from 10 years prior to the report; this was the only time she had asthma, and her physician said her asthma can come on because of being sick). The patient stated that she generally has higher blood pressure than she would like, but she is otherwise very healthy, and never had an allergic reaction to anything. Family history relevant to the adverse events was none. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) for high blood pressure, valacyclovir (VALACYCLOVIR), rosuvastatin (ROSUVASTATIN), omega-3 nos (OMEGA-3 NOS, capsule), estrogen (ESTROGEN) for Hormone replacement therapy, progesterone (PROGESTERONE, 100 mg capsule) for Hormone replacement therapy, all were from unspecified date and ongoing. It was reported that patient gets her flu shot every year and never had an adverse reaction. The patient reported that she had an allergic reaction to the first dose of PFIZER-BIONTECH COVID-19 VACCINE she received last Wednesday (03Mar2021) after an hour after she received it (18:45) while driving. She mentioned that she saw on the package insert what a severe allergic reaction would include. She experienced swelling of the face and a fast heartbeat but no difficulty of breathing on 03Mar2021. The patient further explained that she had her first dose of the PFIZER-BIONTECH COVID-19 VACCINE on 03Mar2021 around 17:15 at a pharmacy. She left the pharmacy around 17:30. While she was driving home, she started to feel her heart racing really fast and felt like her throat was constricting within about 30 minutes of being administered the vaccine, by around 17:45. She was very flustered while driving home which is usually about 30 minute drive; but somehow she missed her exit and it was rush hour so it was about 18:15 when she got home. When she got home her husband asked her if she had been crying because he said her face looked weird. She told him he thinks her face is swollen. All of these events lasted maybe 1-2 more hours or less after she got home around 18:15, maybe a few hours before she recovered completely. She was expecting soreness and pain from the PFIZER-BIONTECH COVID-19 VACCINE but was not expecting the fast heartrate or swelling. She was reading through the information she got from the pharmacy for the PFIZER-BIONTECH COVID-19 VACCINE because she was a little concerned about getting the second dose due to these events. She has never had an allergic reaction to anything before and wondered if she should go to a hospital for her second dose of the PFIZER-BIONTECH COVID-19 VACCINE in case she has these events again, or a worse reaction. She asked about these events and dosing recommendations for the Pfizer. The reported adverse events did not require a visit to the emergency room or physician office. The patient was not hospitalized. Outcome of the events was recovered on 03Mar2021.
58 2021-03-30 swelling, peripheral swelling, swelling face numbness, tingling and swelling on the right side of face and head down right arm and chest; numbnes... Read more
numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206), via an unspecified route of administration on 08Mar2021 at 11:15 (at the age of 58 years) at a single dose in the right arm for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included irbesartan; nifedipine; spironolactone; and estradiol. The patient did not receive any other vaccines within 4 weeks prior COVID vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not pregnant at the time of vaccination. On 08Mar2021 at 11:30, the patient experienced numbness, tingling and swelling on the right side of face and head down right arm and chest. The events resulted to Emergency room/department or urgent care visit. The patient was hospitalized on an unspecified date due to the events. Patient was given Benadryl antihistamine w/IV Cat-Scan other work up as treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.
58 2021-03-31 lymph node swelling Patient had swollen lymphnodes the size of baseballs the next days and her kidney function decreased... Read more
Patient had swollen lymphnodes the size of baseballs the next days and her kidney function decreased after getting the 1st dose.
58 2021-03-31 lymph node swelling I woke up throughout the night first night with left arm very sore feeling like an elephant trunk. I... Read more
I woke up throughout the night first night with left arm very sore feeling like an elephant trunk. In AM I woke up and felt ill. Throughout the day my temperature went up to 102 by the afternoon. I had headache, bad muscle pain and aches and generally felt miserable. Also, the gland under my arm pit was extremely swollen for 3 full days the size of a baseball. It hurt to rest my arm to my side. That second night, I took fever reducer before I went to bed. Fever broke and I soaked through 3 pairs of pjs. The next day my fever went up to 100.7. I didn't take any more fever reducer. Third day it went up to 99.7. Fourth day normal temp but then I had extreme fatigue starting fourth day to where I barely had energy to sit up or even walk to the bathroom. I tried to do my online remote work that week but only worked 1/3 my schedule due to extreme fatigue. One day I was in the kitchen and had to drop to the floor and rest to get enough energy to walk back to my bedroom. The extreme fatigue lasted a good 5-6 days then the following week I pushed through my online work without reducing my hours but would go straight to bed right afterwards due to fatigue. I have struggled with Epstein Barr virus since I was 23 and get fatigued after getting strep or exercising too much or other illnesses so chalked it up to the EBV. I still had minor stabbing pain under my armpit until the past couple of days. My energy is now back to normal.
58 2021-03-31 lymph node swelling Nausea, headache day after injection. 1/2 baseball size swelling under right arm 2 days after inject... Read more
Nausea, headache day after injection. 1/2 baseball size swelling under right arm 2 days after injection
58 2021-03-31 lymph node swelling Feverish feeling in face, slightly dizzy , felt like nodes under left side of chin were getting tigh... Read more
Feverish feeling in face, slightly dizzy , felt like nodes under left side of chin were getting tighter, i.e., labored breath slightly, felt like heart was racing for a few seconds. Sat down and waited for 10 minutes. Feelings subsided. Did not report this to the pharmacist.
58 2021-03-31 peripheral swelling Sore arm, migraine, fingers swelling
58 2021-04-01 swelling 1/15 vaccination I didn't have any problems except a super sore arm. Tuesday afternoon, I had a ras... Read more
1/15 vaccination I didn't have any problems except a super sore arm. Tuesday afternoon, I had a rash, super bright red, that covered where clothing was under my scrubs on my legs, partly on arm. Lasted until Friday afternoon, 1/22. Hives plus red areas. It did expand to my face, beyond where clothing was. It was not itchy, swollen uncomfortable. 1/22 Dermatologist. They took pictures and compared to the pictures online with the CDC. The doctor stated I should not take any more vaccines based on what we know right now with the vaccines. I did go see an allergist. Dr. stated needed pics and notes. And she said yes, you should NOT have any more vaccinations. I kept taking the Zyrtec for week and half.
58 2021-04-02 lymph node swelling Around ten and a half hours after my injection, I started to experience extreme fatigue. Went to be... Read more
Around ten and a half hours after my injection, I started to experience extreme fatigue. Went to bed and woke up an hour later to a severe headache. Through the night I had fever (100.7), chills, muscle aches which kept me up all night. Around 1:00 pm the following day I finally started to feel better. Rested throughout the day and slept fine that evening. The next day I woke up with a swollen lymph node under the armpit of my left arm which received the vaccine. That tenderness went away around three days later.
58 2021-04-02 swelling face, swelling 3 weeks after second dose, March 20 2021 started with severe hives all over the body, including scal... Read more
3 weeks after second dose, March 20 2021 started with severe hives all over the body, including scalp and face, swelling. Presently on: Prednisone, Levocetirizin-E, Pepcid, Triamcinolone cream.
58 2021-04-03 lymph node swelling six days after my 1stPFZER dose93/23/2021 I had cold chills,fever ,headache ,swollen lymph nodes,ve... Read more
six days after my 1stPFZER dose93/23/2021 I had cold chills,fever ,headache ,swollen lymph nodes,very bad lower abdominal pain(I almost went to the emergency room for)but did not seek a doctor as the severe abdominal pain eased up after 48 hours as wells as the other symptoms
58 2021-04-03 lymph node swelling headache; sore throat; swollen glands on right side of throat; This is a spontaneous report from a c... Read more
headache; sore throat; swollen glands on right side of throat; This is a spontaneous report from a contactable nurse (patient herself). A 58-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E19261), intramuscularly in left arm on 04Feb2021 at 08:00 as a single dose for COVID-19 immunisation. The patient's medical history included osteoporosis, essential tremor, right hip replacement; All from an unspecified date in 2019 to an unspecified date. Concomitant medications included other medications in two weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E41284), intramuscularly in left arm on an unspecified date in Jan2021 at 14:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation, codeine, and experienced known allergies: Codeine, meloxicam and experienced known allergies: Meloxicam, erythromycin and experienced known allergies: Erythromycin. No COVID prior vaccination. No other vaccine in four weeks. No COVID tested post vaccination. On 14Feb2021 at 06:00 AM, the patient experienced headache almost daily since #2 (just suttle), sore throat and swollen glands on right side of throat 11 days after #2. The patient was treated with over-the counter treatment for the events. The outcome of the events was recovering.
58 2021-04-03 swelling face Left side of my face swollen up. Left Jaw muscle swollen. Last one day, full recovery on second day.
58 2021-04-04 lymph node swelling, lymph node pain The lymph nodes under my left arm swelled -- some are the size of walnuts. They are painful and ach... Read more
The lymph nodes under my left arm swelled -- some are the size of walnuts. They are painful and achy. Managed with Tylenol. I've heard from friends that it's a common occurance, but I'm not reading about it in the media as a side affect.
58 2021-04-04 lymph node swelling Myalgia, malaise, headache, burning pain in right axilla for 3 days. Then, lymphadenopathy in right ... Read more
Myalgia, malaise, headache, burning pain in right axilla for 3 days. Then, lymphadenopathy in right axilla
58 2021-04-04 peripheral swelling Approximately 18 hours after receiving the second Pfizer COVID-19 injection, I experienced chills, f... Read more
Approximately 18 hours after receiving the second Pfizer COVID-19 injection, I experienced chills, fever, extreme tiredness, and nausea. Approximately 24 hours after receiving the injection, I experienced swelling, extreme tenderness and slight pain under my left armpit. After about two days, I didn't experience symptoms any longer.
58 2021-04-05 lymph node swelling rash difference place legs arms back and swollen gland
58 2021-04-05 peripheral swelling Covid arm - rash, warmth, itch, swelling, pain sensation like "bee sting" Started 24-26h after vacci... Read more
Covid arm - rash, warmth, itch, swelling, pain sensation like "bee sting" Started 24-26h after vaccine On day 2 of rash now
58 2021-04-06 lymph node swelling a couple of hours after the shot, I started to get dizzy, stomach a little off. a headache started.... Read more
a couple of hours after the shot, I started to get dizzy, stomach a little off. a headache started. with in 3 hours from the vaccination time, I had bad-not severe headache pain on the left side of my head. throat/neck gland swelled. heart was racing. the pain went from my vaccination site up my shoulder blade to the back of my neck and up into the left side of my head. once I laid down the heart racing slowed down. I was able to fall asleep and slept for 3 hours. when I awoke, I had slight headache, dizziness was gone, swelling in my neck was gone, heart rate back to normal. I had much discomfort in my shoulder. the following day I was extremely tired. by the end of the day I felt much better.
58 2021-04-06 lymph node swelling Sore throat 3am after injection in prior mid-afternoon; and Swollen lymph nodes noticed 9am after in... Read more
Sore throat 3am after injection in prior mid-afternoon; and Swollen lymph nodes noticed 9am after injection in prior mid-afternoon
58 2021-04-06 lymph node swelling 1. Severe hip STIFFNESS within 15 minutes, worsening over period of hours to involve low back, then ... Read more
1. Severe hip STIFFNESS within 15 minutes, worsening over period of hours to involve low back, then over next day felt terrible stiffness throughout entire pelvis and adjacent joints; gradual improvement over 3 or 4 days, almost completely resolved, with some nagging reminders now and again, until today, with returning stiffness, like a flare up, lasting the entire day so far, along with severely heightened stiffness in finger joints. 2. SWOLLEN GLANDS at throat, most noticable beginning 4/1/2021, worse upon waking, and has gotten progressively worse each morning, now reminiscent of mumps (as a child). Settles down as day progresses. No sore throat or fever to report, however.
58 2021-04-06 swelling face tingling sensation around the face, lips and throat--sensation of swelling of cheek--no swelling of ... Read more
tingling sensation around the face, lips and throat--sensation of swelling of cheek--no swelling of tongue, no CP or SOB IM 50mg Benadryl given and observed in medical tent for 60 minutes. Vitals stable, improved symptoms during the observation time.
58 2021-04-06 swelling Swelling back of neck lasted 2 hours, arm pain for 24 hours: tiredness ongoing past 2 days; flushed... Read more
Swelling back of neck lasted 2 hours, arm pain for 24 hours: tiredness ongoing past 2 days; flushed face, but no fever. Headache 24 hours.
58 2021-04-07 lymph node swelling Injection shot swollen and red and lymph nodes in neck swollen
58 2021-04-07 peripheral swelling Chills (possibly before I realized I was having side-effects) Extreme Fatigue Extreme Muscle Sorenes... Read more
Chills (possibly before I realized I was having side-effects) Extreme Fatigue Extreme Muscle Soreness (hurt to touch my own body, to sit, to lay) Extreme Joint Pain (swollen hands from trying to use computer)
58 2021-04-07 swelling face right sided facial swelling, throat clearing; 1st vaccine - facial swelling 9 hrs after vaccine; ... Read more
right sided facial swelling, throat clearing; 1st vaccine - facial swelling 9 hrs after vaccine; resolved with zyrtec.
58 2021-04-08 swelling tongue paresthesia Narrative: Immediately following administration of first dose of Pfizer COVID19 ... Read more
tongue paresthesia Narrative: Immediately following administration of first dose of Pfizer COVID19 vaccine, patient reported pruritus, bumps on sides of R then L neck, and tingling/stinging sensation of the R side of her tongue without swelling of tongue/lips elsewhere. Patient took personal supply of diphenhydramine 50mg and was transported to ED for further evaluation. Upon arrival to ED, no additional symptoms reported. She denied any areas of urticaria/hives at that time and stated the neck is the only area of rash she noted, and she currently has pruritus only around the neck area and still notes small bumps. Her tongue felt improved but not normal and she denied any tongue/oral swelling, wheezing, dyspnea, chest pain, syncope, LH, palpitations, confusion, n/v/d/abd pain HA, focal neurological complaints, seizures, or any other acute symptoms. Patient had an extensive history of multiple other allergies. Diagnosis included early angioedema and second dose not recommended by ED provider. Methylprednisolone and famotidine administered in ED. Patient discharged from ED with prednisone and famotidine. Previously prescribed epinephrine for anaphylactic seafood allergy.
58 2021-04-08 lymph node pain 24 hours after receiving the shot I started to feel achy, tired, and got the chills. That lasted to... Read more
24 hours after receiving the shot I started to feel achy, tired, and got the chills. That lasted to the next morning and then I had pain in my left arm pit near my lymph nodes and breast. This pain went away in a day or two.
58 2021-04-09 peripheral swelling developed acute delirium; redness in arm; Right arm swelling; After that very wild, I was screaming.... Read more
developed acute delirium; redness in arm; Right arm swelling; After that very wild, I was screaming. Very scary. My memory was gone; she passed out at home; she is very depressed has anxiety; she is very depressed has anxiety; panic attack; gained 16 pounds; vomited; loss of appetite; body ache/pain; This is a spontaneous report from a contactable Other HCP (patient). A 58-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: NN6206 and expiration date: Not available), via an unspecified route of administration in the right arm on 04Mar2021 12:00 as a single dose for COVID-19 immunisation. Medical history included removed brain tumor, she has sciatic nerve damage on left arm and left leg and is paralyzed, coma, chronic body aches, seizures, bad vision, high blood pressure and three brain surgery, short term memory. The patients historical vaccine included Flu vaccine injection in right arm deltoid muscle. The patient's concomitant medications included Oxycodone (5mg three times a day tablet) been taking for 3 years since she has brain tumor removed and for chronic body aches and Lyrica. On an unknown date, the patient gained 16 pounds. In Mar2021, the patient experienced she passed out at home and she was very depressed, anxiety, panic attack, body ache/pain, vomited and loss of appetite. On 04Mar2021, the patient experienced right arm swelling, screaming, scary, memory was gone. On an unknown date, she experienced developed acute delirium. On 06Mar2021, the patient had redness in arm. The patient was in the hospital for 4 days and was admitted on 14Mar2021. Her memory came back little by little and side effect of vaccine it says that if she had side effects from first one do not take second dose because it is worse and she is scared to be admitted to the hospital and does not want to experience that again. She was taking pain medication and did not tell her she cannot take Tylenol of course with body aches they did not tell her. It was not specific acute delirium it is a psychiatric disorder and she was wild and has never been like that before, she was tied up to the bed. The reporter states that she is disabled. She has bad vision and she is by herself at home. She is 5 1/2 already going down. She is not going to get the second one until get report results because it is ridiculous, and she is very nervous as she was admitted at night to the hospital. Body ache happened 24 to 36 hours after vaccine not that severely unusual as it went away, and she has a chronic illness and is in a wheelchair from chronic pain. Reporter stated she could not swallow liquid or eat food and she was scheduled for a cat scan, but she could not go since she has been on the phone with Pfizer to get truth and fairness. Reporter stated yesterday this started getting better. Reporter stated was discharged from hospital last Tuesday but had pain at home. Developed acute delirium: stated when she woke up in the ER the next day in few hours she was admitted and in the ER she was crazy and tried running even though she cannot run because she is paralyzed and she did not remember nothing. Reporter stated no she did not get it that when she was discharged, it had been 48 hours. Pain started 48 hours after the vaccine. She has chronic pain the pain is not that excruciating, and it has stopped. She could not remember what happened but just knew it was redness and hurt a lot. Her memory and everything came back. States she had MMR (as provided by Reporter ) done, because of pain in her whole body and everything came back negative. She had terrible pain, she asked to be given pain medication, and was given pain medication. Reporter stated it disappeared about one week now it disappeared and has recovered completely. Reporter stated black and blue inflammation and it does not hurt and the pain it went away. She was discharged from the hospital and discharge paper said second vaccine on 26Mar2021. She has been taking Oxycodone pain medication, reporter thinks she even got a higher dose since the pain was excruciating. The patient did not take any vaccines with 4 weeks. No Relevant Tests were performed. While providing an AE for the COVID vaccine she took Tylenol and Motrin as treatment, on top of it, but the pain didn't go away. She has been taking Oxycodone pain medication, reporter thinks she even got a higher dose since the pain was excruciating. The clinical outcome of events gained 16 pounds, passed out at home, depressed, anxiety, panic attack, body ache/pain, vomited and loss of appetite, right arm swelling, screaming, scary, developed acute delirium, redness in arm was unknown whereas of memory gone it was recovering/resolving.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events peripheral swelling, amnesia, delirium, loss of consciousness, depression, anxiety, panic attack, and erythema and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
58 2021-04-10 lymph node swelling 24 hours after Vaccine... injection site pain, chills, fever, fatigue, headache, feeling unwell, aw... Read more
24 hours after Vaccine... injection site pain, chills, fever, fatigue, headache, feeling unwell, awoken lymph nodes. Stayed in bed 16 hours. All symptoms disappeared in 24 hours.
58 2021-04-10 swelling face Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of F... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Hypertension-Mild, Additional Details: pt states heart rate increased, inside of lips swell, exhausted, tip of tongue tingling, taste of chemicals in mouth. it is subsiding now. we were monitoring her for 30 minutes. may need follow up
58 2021-04-11 lymph node swelling, lymph node pain Headache-1 day Swollen and EXTREMELY TENDER lymph nodes in my left armpit-3+ days
58 2021-04-11 peripheral swelling, lymph node pain, lymph node swelling Day 1&2: Aches,slight fever, headache Day 3: breast tenderness, followed by lymph node under right ... Read more
Day 1&2: Aches,slight fever, headache Day 3: breast tenderness, followed by lymph node under right arm swelling/very painful (12 hours after tenderness began) face swelling under eyes, hand swelling and hand joint pain Days 3/4/5: joint pain spreading throughout body. Some sharp pains in various joints Day 5/6: migraine again, not as severe (responded to my medicine better) day 6 migraine better (didn't take medicine)(zololatriptan) Sharp pain in my lower right side (like the ovarian cyst pain I had when I was ovulating)
58 2021-04-11 swelling 2 Events: Evening following 2nd injection, I went from having no dental issues to having severe toot... Read more
2 Events: Evening following 2nd injection, I went from having no dental issues to having severe tooth pain on lower left jaw, roughly 4-5 teeth in from back molar. Swelling began within hours accompanied by intense pain and sensitivity. By that Sunday evening, swelling had extended up to left eye, over to bottom of ear, and down neck to baseline and half way to center jaw line. Bruising present. Throbbing was constant. Made emergency dental appointment for Monday, but by that Sunday night, I could not stand it any longer and was afraid the swelling would extend to my throat. Went to ER, who diagnosed an abcess under the tooth root. Perscribed pain pills and antibiotics. Saw dentist Monday, who scheduled me for an emergency root canal on Tuesday. Got root canal on a tooth I never had problems with before, although there certainly could have been an issue brewing but not yet pronounced. Anyway, he also drained what he called an unbelievable amount of infection fluid (pus) after making an incision in my gum line and basically squeezing my face to get as much out as he could. Said he never saw anything like it. And for me to go from 0 to that in a matter of days was incredible. I thought perhaps it was an immune response? At the same time that I was experiencing the dental issue, I started to develop a strong dry cough. I have a light former smokers cough, and have had pneumonia many times, but this cough was different. Every day it has gotten strongly, but is very much intermittent. I now go into fits of coughing that last one to two minutes and so strong and to the point where I have either fractured my rib directly beneath my right breast, or something else is going on. These fits can last minutes, but never result in expulsion of phlegm. The coughing fits also occur if I take a deeper breath, walk too far, laugh, or talk too long. Very strange. I am very fatigued and have been since the onset of the dental issue reported above. While the dental issue is gone since the absess was drained, the cough is still present, and wakes me up every single night too with coughing fits. The cough has loosened up a bit. I would go to the doctor, but I am in the middle of a move from MO to AZ, and just arrived in AZ after a 3 day drive. So, first off, I am reporting this issue. And next, I will seek a new doctor in Arizona if this cough continues.
58 2021-04-12 lymph node inflammation I felt very down, lymph nodes appeared in my left clavicle. Very painful. I put ice on and take ibup... Read more
I felt very down, lymph nodes appeared in my left clavicle. Very painful. I put ice on and take ibuprofen for the pain. Today 5 days later I feel better the lymph nodes and the pain have diminished.
58 2021-04-13 lymph node swelling Swelling and pain of supra clavicle/neck lymph nodes on left side
58 2021-04-13 lymph node swelling swollen lymph nodes under armpits, pain on arm
58 2021-04-13 swollen extremities Large, very sore, lump under left arm pit and side of left breast. Chills, tiredness, low grade fe... Read more
Large, very sore, lump under left arm pit and side of left breast. Chills, tiredness, low grade fever, body aches and pains in neck and lower back mostly.
58 2021-04-14 bursitis After first dose, pt had persistent L deltoid pain. Within 24h after second dose, she had fever and ... Read more
After first dose, pt had persistent L deltoid pain. Within 24h after second dose, she had fever and worsening redness and swelling of the L deltoid. She eventually was admitted and found to have a sub deltoid bursitis that required incision and drainage. Fluid was inflammatory but cultures off of antibiotics remained negative.
58 2021-04-16 lymph node swelling Fever 101.1, chills, lymph node under left arm swollen and very painful, neck aches,bilateral should... Read more
Fever 101.1, chills, lymph node under left arm swollen and very painful, neck aches,bilateral shoulders ache,upper back aches,bilateral wrist aches,nauseous,extreme fatigue, chest pain anxiety short of breath
58 2021-04-16 swelling Left side of neck swollen and painful this morning. Prior 24 hours had fatigue.
58 2021-04-18 lymph node pain Achy upper arm muscle (from both shots) Sore & tender Lymph nodes. So far it's lasted a week, altho... Read more
Achy upper arm muscle (from both shots) Sore & tender Lymph nodes. So far it's lasted a week, altho the intensity has lessened.
58 2021-04-18 peripheral swelling Sever tingling and numbness all over my body, face, arms, fingers, legs, feet etc, Chills, Tiredness... Read more
Sever tingling and numbness all over my body, face, arms, fingers, legs, feet etc, Chills, Tiredness, headache, muscle pain, nausea, tenderness in the arm, swelling, Swelling hands and feet, dizzy
58 2021-04-20 swelling face Hives on body, in mouth; facial swelling, swelling around eyes. New reactivity to soaps, shampoos, ... Read more
Hives on body, in mouth; facial swelling, swelling around eyes. New reactivity to soaps, shampoos, makeup, - seems to be things containing PEG and palm oil and coconut. Also reacted with mouth hives from avocado. Hives still present as of today 4/21/2021, but reducing in frequency and severity. Some hives present after first vaccine, and did contact physician . They remained up until 2nd dose at which time they increased in frequency and amount. Had throat swelling, swollen eyes and hives around eyes after ingesting salmon post 2nd vaccine. Not a previous food allergy. Shortness of breath was exacerbated after first dose of Pfizer, with significant increase in shortness of breath and accompanying throat tightness after 2nd dose.
58 2021-04-20 swelling I got a Mighty sore arm about 4 hours after injection. 30 hours later I began to feel agitated and g... Read more
I got a Mighty sore arm about 4 hours after injection. 30 hours later I began to feel agitated and grouchy. I woke up about 44 hours after vaccine with a painful and swollen left thumb joint. I felt strangely tired. While walking a couple of hours later I felt drunk and dislocated from my body. 48 hours after receiving the vaccine, I felt a shocking jolt to my entire body. Immediately my left arm began a deep painful tingling from my shoulder to my fingertips, then began to feel numb and tingling and as if it were swelling. I lost my vision, felt like I was going to pass out, turned extremely pale, broke out in a cold sweat, then my shins and feet began to tingle. I felt as though I couldn?t breathe. My vision came back but my body felt dislocated and my head a cinder block. It took great concentration to move my limbs and speak. I couldn?t find the words I wanted. This lasted for about 15 minutes just like a complete shock to my nervous system. I was very irritable and exhausted for 4 days following.
58 2021-04-20 swelling Three days after my second vaccine, I had blood in my stool. Has not happened since. 24 days afte... Read more
Three days after my second vaccine, I had blood in my stool. Has not happened since. 24 days after my second dose, I developed supraclavicular swelling (puffiness) on my right side. Also discomfort in my neck. I still have it.
58 2021-04-21 swollen extremities inflammation in sinuses and ears, sore throat-was tested for strep and covid and both negative. Deve... Read more
inflammation in sinuses and ears, sore throat-was tested for strep and covid and both negative. Developed tinnitus in left ear(same side as shot) on day 5 and had plugged ear. Have never had tinnitus in the past. Blood pressure went up by 30 points. Have generally not felt well since vaccine. Doctors called it an adverse immune reaction. Week 3-thyroid swelled and am now dealing with that. Went for ultrasound today
58 2021-04-21 oral herpes Initially after shot, had headache and sore arm. @ 10:00 pm began with chills, escalated to very hig... Read more
Initially after shot, had headache and sore arm. @ 10:00 pm began with chills, escalated to very high fever, shaking, severe joint pain, massive migraine headache, cough, aches and pains all over body. Could not get out of bed. Intense reaction lasted until Tuesday around 8:00 am. Then fever came and went for rest of day, migraine, cough, runny nose, burning sinuses, exhaustion and aches and pains continued through day. By 9:00 pm Tuesday evening, migraine moved to bad headache, aches and pains/joint pain subsided, cough and sinus issue remained along with exhaustion. Wednesday 6:00 am regular headache, minor cough, minor cold like symptoms with some runny nose and sinus burn.
58 2021-04-21 peripheral swelling 2.24 - Received 1st dose of vaccine at 2 pm Pfizer EN6202. Left arm. Had a little soreness in arm ... Read more
2.24 - Received 1st dose of vaccine at 2 pm Pfizer EN6202. Left arm. Had a little soreness in arm next day and several days later a little bruise. 2.27 - Noticed around 6 little pimples on my scalp. Just scratched them, they scabbed, thought it was odd. 2.28 Noticed little pustules on my legs. In the coming days they appeared all over my torso and some on my arms as well. Also a few spots on hands, inside ears was scaly and very dry skin on sides of nose where it connects with face. 3.9 Contacted Dr. Rhuemotology, about bumps thinking they might be an reaction to Humira which was started in the fall. She didnt think it was Humira and suggested dermatologist. Contacted Nurse bVie as well. She didnt think it was the Humira. 3.17 Appointment with Dr. Dermatology, She did a punch biopsy on left leg and took a bacterial culture from pustules under left breast. Notes said after pustules on head appeared on legs, axillae, under breasts, genital area. Papules. Pustules w/ erythema 3.20 Started having issues with left eye, dry and a bit painful. Felt like it was perhaps scratched. 3.22 Dr. prescribed Triamcinolone Cream. Result of biopsy, etc. was that it was not an infection, not psoriasis. It was spongiotic dermatitis which is an eczema rash or reaction to a medicine. 3.22 - Vaccine Received 2nd vaccine dose, same place, 2 pm. Pfizer EN6206 Left arm Did not have soreness, redness, etc. at injection site. 3.22 Left eye very painful. Ophthamology, 3.24 Dr. diagnosed epithelial basement membrane dystrophy. Protocol was Besivance (besifloxacin ophthalmic suspension, 0.6%) 1 drop 3x/day for 3 days Genteal gel 4x a day Muro 5% ointment (sodium chloride hypertonicity ophthalmic ointment, 5%), 1 application at bedtime 3.29 Follow up with Dr. She noticed rash on my face that wasn't there before ? under left eye and on eye lids of both eyes. Issue had healed 80%. 3.31 Contacted Dr. about RA flare. 4.1 Was prescribed Methylprednisolone 4 mg dosepk. Took immediately and started to feel better within hours. Elbow swelling went down, energy overall went up. 4.2 Elbow pain greatly reduced, body pustules and bumps going away. 4.10 Elbow pain back, flexibility compromised. 4.22 First day without noticing any new pustules. Elbow pain diminished. Most of elbow flexibility has returned. Left eye issue may
58 2021-04-22 axillary mass Patient had extreme pain, fatigue, chills, fever. Patient developed lump in arm pit, approx 1 cm tha... Read more
Patient had extreme pain, fatigue, chills, fever. Patient developed lump in arm pit, approx 1 cm that is still there currently. Patient could not get out of bed for over 24hrs post 2nd dose. Reporting kidney pain and full body pain.
58 2021-04-22 lymph node swelling The next day I realized the lymph nodes under my arms were swollen, in the arm of the vaccine was wo... Read more
The next day I realized the lymph nodes under my arms were swollen, in the arm of the vaccine was worse, today it is less swollen in the arm of the vaccine, in the other it has disappeared, I only took Tylenol.
58 2021-04-22 swelling face, oral herpes Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injec... Read more
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Severe, Additional Details: Blistering in mouth, urgern diagnosed with infection in arm. Severe redness/sweliing at injection site, more than six inches surrounding site. TPrescribed cephalexin 500 mg (as needed if arm swelling continues, pt did not take) and valtrex 1 gram for fever blisters
58 2021-04-22 swelling, swelling face Immediate chest tightness. 10 minutes in severe burning at on upper arm and pain. At same time entir... Read more
Immediate chest tightness. 10 minutes in severe burning at on upper arm and pain. At same time entire stomach area, abdomen began with intense itching. No hives, swelling or redness. Tachycardia present 139. sPO2 97, respiration?s 22. Stayed in observation for 30 minutes, when outside and in car left eyelid itching and now swollen. When home Dyspnea began and itching and prickling sensation began systemically all over body. Took 25 mg. Diphenhydramine and 20 mg. Famotidine. 20 minutes later worse and now upper lip swollen and numb, facial puffiness, nose extremely swollen and red, neck swollen and upper chest red. Got Epi Pen and drove 25 minutes to ED. No issues with breathing, or swelling of throat, tongue or uvula. BP 151/91, HR 112, respiration?s 18 at triage taken into ED and given 60 mg. po of Prednisone observed 4 hours. At 2 hours symptoms began to return to baseline, tachycardia resolved now 87. Discharged with 50 mg. Prednisone daily for 4 days, Diphenhydramine 50 mg. q6h for 13 doses and Famotidine 20 mg. bid x3 days. Referred to immunologist.,
58 2021-04-22 swelling Over all body rash - giant hives and swelling
58 2021-04-23 lymph node swelling Red rash in the back of my left leg and swollen lymph node in my left leg groin area.
58 2021-04-23 swelling 5 inch area bruised/swollen/harden/with blisters
58 2021-04-24 lymph node swelling 8 hours after receiving injection, started having a sore throat. 48 hours after injection noticed a... Read more
8 hours after receiving injection, started having a sore throat. 48 hours after injection noticed a small grape size lump/knot close to collar bone (lymph node?) on left side which is the injection side. 72 hours after injection, I had lost my voice, not totally. Sounds like I'm whispering when I talk. I also had the normal reported sore arm, but was quite bothersome for 3+ days. I have also noticed some shortness of breath and still quite tired after doing several small chores. I am currently on day 11 after injection, and have another smaller lump/knot beside the first one that appeared by my left collar bone. The only side effect that has dissipated is the sore arm, I still am having fatigue, shortness of breath, lumps near collarbone and loss of voice. I have not seeked medical treatment since I have no health insurance. I felt like these would subside, but have not so far. I am really hesitant to receive my 2nd dose since claims are that it is worse that the first, regarding side effects. I feel that my body has not recuperated from trying to build up my immunity. As stated above, my side effects have not subsided as of today's date, 11 days after receiving the 1st dose injection.
58 2021-04-24 swelling face Sinuses felt congested/Feels like left side of head is congested; Left ear ache/inflammation; Moment... Read more
Sinuses felt congested/Feels like left side of head is congested; Left ear ache/inflammation; Momentary buzzing sound in left ear; Vertigo at night; Feeling foggy; Autoimmune fluid response (injection left arm); Left eye felt inflamed; Face felt swollen/fluid; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in the left arm, on 30Mar2021 at 14:00 (Batch/Lot Number: 8733), at the age of 58 years old, as a single dose, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included asthma, Crohn's disease, and asymptomatic mild thrombocytopenia. The patient had allergy to penicillin, sulfa, preservatives, azithromycin (ZPACK), dust, mold, and sulfites; she also had seasonal allergies. Additionally, allergy to food included wheat, rye, oats, barley, quinoa, tomato, potato, celery, peas, banana, cantaloupe, strawberries, chocolate, tea, beef, and caffeine. In 1982 the patient reacted to an unspecified allergy shot with anaphylaxis and 4-day delayed reaction of serum sickness including liver dysfunction, swelling, rash, nausea, not being able to keep food or liquid down, treated with hydroxyzine (ATRAX) (started at day 5 of serum sickness which helped clear it up). The patient had not had COVID-19 prior to vaccination withy BNT162b2. Concomitant medications included mesalazine (LIALDA), cetirizine hydrochloride (ZYRTEC), mometasone furoate (ASMANEX), fluticasone propionate (FLONASE), and vitamin D. The patient had not received any other vaccines during the 4 weeks prior to BNT162b2 administration. The patient stated that 20 minutes after vaccination her left eye felt inflamed and 3 hours after vaccination her face felt swollen/fluid. The patient stated waking-up on 04Apr2021 at 06:00 AM with momentary buzzing sound in the left ear, ear ache/inflammation, sinuses feeling congested, lightheaded/dizziness all day, vertigo at night and on the following morning when lying on the left side, and feeling dizzy/lightheaded for 3 more days. The patient also reported feeling foggy, feeling like her left side of head was congested, and autoimmune fluid response (injection left arm) (as reported), all on 04Apr2021. Due to the events, the patient consulted a doctor or other healthcare professional office/clinic visit. No treatment was required for the events. The patient was not tested for COVID-19 after vaccination. The patient was recovering from all reported events with the exception of buzzing year which resolved on 04Apr2021.
58 2021-04-24 swelling face She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my... Read more
She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my tongue and cheeks; cold rush throughout my body; hot flash; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 58 years of age), dose 2 via an unspecified route of administration, administered in arm left on 06Apr2021 09:45 (Batch/Lot Number: ER8734) as a single dose for COVID-19 immunisation. Medical history included acid reflux, pre type II diabetes, Hashimoto's disease and possible Sjogrens; she was allergic to shellfish and berries. The patient had unspecified concomitant medications. The patient previously took and had allergies to sulfur, epinephrine and lidocaine. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number EN6207) (at 58 years of age), dose 1 in the left arm on 16Mar2021 for COVID-19 immunisation. The patient was not pregnant. The patient had no covid prior vaccination. She has not been tested post vaccination. It was reported that on 06Apr2021 10 AM, after just 13 minutes (as reported) of the shot, the patient experienced swelling of her tongue and cheeks along with a cold rush throughout her body followed by a hot flash. She felt unstable and felt like she might pass out. The events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events- treatment included BENADRYL day 1 and Prednisone added day 2. The patient was recovering from the events.
58 2021-04-24 swelling face Shortness of breath; itching; hives; face swollen; This is a spontaneous report from a contactable c... Read more
Shortness of breath; itching; hives; face swollen; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered on the left arm on 26Mar2021 09:45 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included thyroid disease, HBP (high blood pressure), mild depression, ADD (attention deficit hyperactivity disorder), and migraines. Patient was not pregnant. There no other vaccine in four weeks. Other medication were taken in two weeks. The patient previously took sumatriptan (IMITREX) and zolmitriptan (ZOMIG) and experienced allergy. The patient experienced shortness of breath, itching/hives, face swollen on 27Mar2021 14:00 that resulted in clinic/ emergency room visit. Patient was given IV steroid, Benadry, Prilosec at hospital. Patient was not diagnosed with covid prior to vaccination and had been tested (nasal swab) post vaccination on 28Mar2021 with negative result. Outcome of the events was recovered with sequel.
58 2021-04-24 swelling, lymph node pain pain by my ear on my face/ lymph node; throbbing pain; swelling; experiencing discomfort; This is a... Read more
pain by my ear on my face/ lymph node; throbbing pain; swelling; experiencing discomfort; This is a spontaneous report from a contactable consumer (patient reported herself). A 58-Year-old non-pregnant female patient received second dose of BNT162B2 (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration to her right arm on 19Feb2021 02:30 PM (Lot number: EN 6201) as single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications were reported as none. She was allergic to celecoxib (CELEBREX) (Known allergies: Celebrex). Other medical history was none. Facility type vaccine: Other. The patient previously took first dose of BNT162B2 (COVID 19, Pfizer) to her right arm on 29Jan2021 02:30 PM as single dose for Covid-19 immunization. Other medications in two weeks was reported none. It was reported that, on 19Feb2021 05:00 PM, three hours after receiving the second vaccine experienced pain by ear on face. With a little research she found out there was a lymph node called preauricular. She had throbbing pain and swelling. It was been three days since Covid shot and still experiencing discomfort. No Covid tested prior/post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
58 2021-04-25 c-reactive protein increased 101.3 temp developed 12 hrs after 2nd Vaccine. Fatigue and weakness lasted until I woke up on 1/26/2... Read more
101.3 temp developed 12 hrs after 2nd Vaccine. Fatigue and weakness lasted until I woke up on 1/26/2021 at 0500. Felt much better & no fever only problem was bilateral Lumbar pain. This pain was mild at first then worsened in the next two weeks also radiating to bilateral hips and buttock. Worsening stiffness and loss of range of motion. Bending over or lifting legs particularly thighs to get in and out of my car was very difficult & painful. Got MRI of the back with was negative.Orthopedic Surgeon?s PA I saw. She felt it was probably a lumbar strain from possible exercise I had done.. Symptoms improved after activity & PT but returned in a day or so & worsened at a night. In the last month spread to shoulders. Got my Internist involved then. Inflammatory markers done 4/13/2021. C Reactive Protein positive at 2.8. Slightly anemia as well. All other markers negative. Polymyalgia Rheumatica diagnosed. Started on Prednisone 20mg 4/14/2021. Symptoms improving greatly.
58 2021-04-25 lymph node swelling, swelling face About a week after the second dose, the right side of my jaw swelled up. It is very tender and painf... Read more
About a week after the second dose, the right side of my jaw swelled up. It is very tender and painful, like a huge swollen gland on my jawline. Aspiririn and ibuprophin do not help vert much.
58 2021-04-25 pancreatitis Patient went to an emergency room for pain and fever and was diagnosed with pancreatitis, something ... Read more
Patient went to an emergency room for pain and fever and was diagnosed with pancreatitis, something she has never had an issue with before the vaccine.
58 2021-04-25 swelling face Patient had the second Pfizer COVID vaccine on 4/20/21 in her left arm. Within 2-3 days, she noticed... Read more
Patient had the second Pfizer COVID vaccine on 4/20/21 in her left arm. Within 2-3 days, she noticed left facial swelling, left facial droop, left ear sensitivity, left eye blurriness. She had a HA for 5 days. She took NSAIDs as needed. States symptoms are persisting.
58 2021-04-25 swelling Local swelling (arm bled quite a bit when she injected the vaccine - nurse said, "well, we have a bl... Read more
Local swelling (arm bled quite a bit when she injected the vaccine - nurse said, "well, we have a bleeder." Arm pain spread to shoulder and then up neck to occipital lobe under skull. Resembles feeling of pinched nerve. Massive headache and unable to rotate head in normal range.
58 2021-04-26 peripheral swelling Patient was vaccinated with an undiluted dose of Covid-19 Pfizer immunization. I called patient and... Read more
Patient was vaccinated with an undiluted dose of Covid-19 Pfizer immunization. I called patient and let her know of our mistake and told her that the dosage given was not harmful, but she may have an extremely sore arm. She stated that she did have sore arm with swelling. She took Tylenol and it relieved her symptoms. She states that she is doing great.
58 2021-04-26 systemic inflammatory response syndrome Patient developed body aches 2 days after vaccination. She subsequently developed cough and shortnes... Read more
Patient developed body aches 2 days after vaccination. She subsequently developed cough and shortness of breath that led to being hospitalized with pneumonia 5 days after vaccination. Pneumonia proved to be rhinovirus by respiratory PCR. Currently is receiving supportive care by mechanical ventilation with ARDS. Question is why such a severe response to rhinovirus infection and whether vaccine induced an inflammatory response causing ARDS / diffuse lung injury.
58 2021-04-27 lymph node swelling after vaccine working arm, all blood in head rushed to feet, lightheadedness, felt like she was goin... Read more
after vaccine working arm, all blood in head rushed to feet, lightheadedness, felt like she was going to drop or die, tremors, body felt like it was growing fur, lymph nodes under tongue, fingers, toes, started to swell.teeth chattering, restless legs, itching legs, sugar swings
58 2021-04-27 peripheral swelling, lymph node swelling 102 DEGREE FEVER, SEVERE HEADACHE (OCULAR MIGRAINE), JOINT PAIN AND BODY ACHES, DIARRHEA AND SWOLLE... Read more
102 DEGREE FEVER, SEVERE HEADACHE (OCULAR MIGRAINE), JOINT PAIN AND BODY ACHES, DIARRHEA AND SWOLLEN LYMPH NODES UNDER ARMPITS (SIZE OF SMALL TANGERINE) FOR 4 DAYS - SINCE THEN PERSISTANT HEADACHE (MODERATE), JOINT PAIN, SWOLLEN FEET, TACHYCARDIA, DIZZINESS, LIGHT HEADED, ODD RAISED RASH THAT COMES AND GOES
58 2021-04-27 peripheral swelling When I initially received the shot with in 15 minutes my pointer finger on my right hand became stif... Read more
When I initially received the shot with in 15 minutes my pointer finger on my right hand became stiff and swollen. The following week, I experienced headache & neck soreness - approximately 7 days after the vaccine. On Friday, I went to the see my doctor for for abdominal pain on my left side. I was diagnosed with Diverticulitis. I was able to take medication and required no hospitalization. Once on meds the swelling and stiffness in my finger subside but returned once meds were stopped. I assume this was due to the anti-inflammatory effect from antibiotic. Please note, I received a full check up and blood work two weeks prior to getting my vaccine. I have had diverticulitis twice before: First occurance: 8/18 - hospitalized 4 day , Second occurance: 4/19 - meds only / no hospitalization. I believe the vaccine caused extreme inflammation in my body and
58 2021-04-28 swelling face Patient presents to the site for her COVID vaccine. She completed her questionnaire to receive the v... Read more
Patient presents to the site for her COVID vaccine. She completed her questionnaire to receive the vaccine and it was determined that she was eligible. She denies any contraindications at this time. She received her vaccine @ 9:40 am and was seated in the vaccine waiting area. She alerted the nurse that she was beginning to feel dizzy around 9:45 am. At that time this NP was alerted and arrived to patient side. The patient was complaining of dizziness, tingling and swelling to the left side of her face, but denies any trouble breathing or swallowing. She was helped to the floor and laid supine and the first set of vitals were obtained. EMS on scene and they hooked her to their EKG machine which obtained the blood pressure and normal sinus rhythm was noted during the entirety of the episode. Monitored patient in supine position until 9:57 am, then she sat up. She reports that she is diabetic and did not eat this morning, so finger stick was obtained which resulted at 105, orange juice was given to patient upon her request. At 10:03 25 mg of benadryl was given due to patient still complaining of facial tingling. Patient's husband was called at that time. She refused to be transported to hospital by EMS. At 10:16 am patient was up to chair and still complaining of facial tingling, but denies shortness of breath or difficulty swallowing. Husband arrived at 10:25 am and transported the patient by private vehicle to the emergency room.
58 2021-04-28 swelling Hives, vomit, 104.5 fever, chills, body aches, joint pain, swelling, diarrhea, fatigue, nausea, no e... Read more
Hives, vomit, 104.5 fever, chills, body aches, joint pain, swelling, diarrhea, fatigue, nausea, no eating , pain, welts, 4 werks
58 2021-04-30 lymph node swelling, lymph node pain swollen lymph nodes that are "extremely swollen and very painful."; swollen lymph nodes that are "ex... Read more
swollen lymph nodes that are "extremely swollen and very painful."; swollen lymph nodes that are "extremely swollen and very painful."; she has incredible pain; fever; experienced shivering that wouldn't stop; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was experiencing swollen lymph nodes that were "extremely swollen and very painful." She had incredible pain and it was hard for her to put her arm down or to reach forward or backwards. On 10Apr2021 she had a fever and experienced shivering that wouldn't stop. The event outcome was unknown. No follow-up attempts are needed. information about lot/batch number cannot be obtained
58 2021-04-30 peripheral swelling Nauseated, heart racing, arm pain, muscle aches throughout body, vomiting, extreme headache, extreme... Read more
Nauseated, heart racing, arm pain, muscle aches throughout body, vomiting, extreme headache, extreme fatigue, chills and fever. At the moment going on 5 days Ist one on 4/06/2021 was nauseated arm pain and fatigue for the first week second week arm turned red and swollen third week got a bruise and when they gave me the second shot they still saw the bruise on the right arm
58 2021-05-02 axillary mass 1 day after vaccine lumps under arms and along collarbone, migraine, chills, fatigue, breast enlarge... Read more
1 day after vaccine lumps under arms and along collarbone, migraine, chills, fatigue, breast enlargement. 3rd day after vaccine left ear pain, difficulty swallowing, but could breath, fever,migraine, chills, ,fatigue, tender breast, breast enlargement. My primary said not to get second dose. Also rash on right arm.
58 2021-05-02 oral herpes Feels like a very light sinus headache, developed a cold sore
58 2021-05-04 lymph node swelling Systemic: Abdominal Pain-Medium, Systemic: swollen lymph nodes under left arm pit-Medium, Additional... Read more
Systemic: Abdominal Pain-Medium, Systemic: swollen lymph nodes under left arm pit-Medium, Additional Details: patient also reported what she describes as menstrual cramping - though she is post menopausal. asked if ab pain upon exam was attributed to enlarged spleen - md didn't because pt followed up with gynecologist who stated that they have seen causes of menstrual like pain in their post menopausal women. still dealing with slight pain - fu with me again - patient chose to get second dose
58 2021-05-04 peripheral swelling Pt presented with persisting right leg pain that seemed to spread to the hip. Pain appeared approxim... Read more
Pt presented with persisting right leg pain that seemed to spread to the hip. Pain appeared approximately 1 day after receiving second dose of Pfizer COVID vaccine. Second dose received on 4/29/2021. Additionally, the patient experienced fever, chills, and fatigue, which had resolved by her presentation to the clinic on 5/3/2021. Pt noted the pain was partially positional, but was constant and found little relief with tylenol purchased over the counter. On physical exam, swelling of the lower extremity was noted with decreased hip ROM. Pain was ellicted on palpation of the calf. No erythema was noted. Pt was sent for Venous Duplex Ultrasound of both legs which was positive for deep vein thrombosis in the right leg.
58 2021-05-05 anaphylactic reaction Vaccine administered. Patient started coughing, scratchy throat, and mucous within 8 minutes. Pt was... Read more
Vaccine administered. Patient started coughing, scratchy throat, and mucous within 8 minutes. Pt was treated for anaphylaxis with epinephrine, albuterol, prednisone, xyzal. Pt recovered in the office and was monitored for 2 hours.
58 2021-05-06 lymph node pain i had the second shot on friday, besides arm hurting, didn't really feel bad until monday, had fever... Read more
i had the second shot on friday, besides arm hurting, didn't really feel bad until monday, had fever hovering over 100, chills, feeling wiped out, no energy, painful glands, continue feeling more or less the same from monday thru wed. fever down by wednesday, had bad headache on thursday and friday. still struggling with a headache as i type...hope it'll go away soon.
58 2021-05-08 swelling, oral herpes, lymph node swelling DAY AFTER SECOND DOSE - GOT CHILLS/FEVER/HEADACHE SEVEN DAYS LATER DEVELOP SEVERE HEADACHES, FEVER B... Read more
DAY AFTER SECOND DOSE - GOT CHILLS/FEVER/HEADACHE SEVEN DAYS LATER DEVELOP SEVERE HEADACHES, FEVER BLISTER -CANKER SORE IN THE RIDE SIDE OF MY CHIN - CHILLS/FEVER 101-103 - SWOLLOW LYMPH NOSE AND KNOTS IN THE BACK OF NECK AND TENDER RISE INTHE LEFT SIDE MY HEAD.
58 2021-05-10 lymph node swelling After the second dose I had fever, body aches and swollen lymph nodes. I went to the doctor and got ... Read more
After the second dose I had fever, body aches and swollen lymph nodes. I went to the doctor and got antibiotics. Nine days after the vaccine I got Bells Palsy and I have not been able to work since then. I noticed when I gargled that night the water was coming out. The following day was a holiday and everything was closed. I was able to see my doctor. My left eye was not closing and I had difficulty eating because the left side of my face was effected. I had to tape my eye shut at night. It is very sad and upsetting because I don't know if it will get better. I have seen a Neurologist. It has been four months and I am still getting therapy for the Bells Palsy. Physical therapy since 04/19/2021 with electrical stimulation. My eye closes a little better and my smile is a little straighter.
58 2021-05-10 swelling she had huge hives all over the left arm and inside the left arm blew up; Alcohol for the itching an... Read more
she had huge hives all over the left arm and inside the left arm blew up; Alcohol for the itching and it seems to take the itch off; She also had swelling after first shot it started on 07Mar2021 got to be the size of a half dollar; that was gone in like 2 days; then reoccurred with second dose; her upper bicep swelling, like a bee sting; That she still has a lump like the size of like a Nickle in her arm and she could move it; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 03Apr2021 14:00 (Batch/Lot Number: ER8729) (at the age of 58-year-old) as single dose for covid-19 immunisation. The patient medical history were not reported. Concomitant medications included none. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 administered in Arm Right on 06Mar2021 14:00 (Batch/Lot Number: EN6206) for covid-19 immunisation and experienced hurt at the vaccine site, hives both arms, itching and swelling. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient Family medical history relevant to events included none. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated after her first shot her arm hurt for a couple of days, at the site, but went away. She also had swelling after first shot it started on 07Mar2021 got to be the size of a half dollar; that was gone in like 2 days; then reoccurred with second dose on an unspecified date in Apr2021. The patient stated after her second shot, within 30 minutes of receiving it, she had huge hives all over the left arm and inside the left arm blew up. She stated she pulled over from driving and her daughter took pictures of it. She stated her daughter went for her first shot as the caller was having her second shot and her daughter wanted to know what to expect so she took pictures. It went away, it was gone in about 2 hours, like you could see where it was, but it was not as raised and itchy. The patient noted hives on the wrist of her right arm, inside the forearm, the upper bicep, that they mostly stayed on her upper body. She stated the next day the hives, raised area went away. She stated 3-4 days later she noticed her upper bicep swelling, like a bee sting, started spreading and had blew up. The patient stated it looked like a very large pork chop. She stated her daughter took pictures and outlined the area and dated it with a pen in case it got bigger. Caller stated it was the width of her bicep and raised and that she had very big biceps. She stated she would put cool water on it and also alcohol for the itching and it seems to take the itch off. After the second dose the hives popped out within like 30 minutes driving in the car huge hives popped out, went away the next day, could still see them but not raised; they would then pop out here and there, but unlike the first dose hives, with second shot she had a really big blast of a reaction with hives, but they didn't pop out as frequently after the second one, they were just here and there. The patient stated her sister experienced, after the shot, an area that had spread like a bee sting. The patient stated she was fine now. That you could still see the area, but it wasn't constantly raised or itchy. That she still has a lump like the size of like a Nickle in her arm and she could move it. The swelling did itch unknown if from skin stretching or actual reaction. The patient did not visit emergency room and physician office. Relevant tests were none. The outcome of the events that she still has a lump like the size of like a Nickle in her arm and she could move it was not recovered and other events was recovering. No follow-up attempts are needed. No further information is expected.
58 2021-05-11 systemic inflammatory response syndrome R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC) N17.9 - AKI (acute kidney injury) ... Read more
R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC)
58 2021-05-13 peripheral swelling 58F w/o significant PMHx presenting to ER with arteriolar thrombosis. Two weeks prior, pt developed ... Read more
58F w/o significant PMHx presenting to ER with arteriolar thrombosis. Two weeks prior, pt developed swelling and pain in left foot (~1 week post vaccine #2). She went toto urgent care and was prescribed ketoconazole cream. She then developed multiple ulcers on her left foot. She presented to ED on 5/12/21. Arterial duplex reviewed complete occlusion of mid-distal SFA into the popliteal and posterior tibial arteries. Pt now returned and ready to be admitted. Of note, pt is a 20 year smoker, half pack a day. Denies any personal or family hx of previous clots. Arterial duplex reviewed complete occlusion of mid-distal SFA into the popliteal and posterior tibial arteries
58 2021-05-14 lymph node swelling Strong pain; Burning in legs, arms and different part of the body; Pins and needles in different par... Read more
Strong pain; Burning in legs, arms and different part of the body; Pins and needles in different parts and electric shock sensation; Pins and needles in different parts and electric shock sensation; Neck lymph nodes inflammation; Body temperature swings from cold to hot and the other way around; This is a spontaneous report from a contactable consumer (patient, reported for herself). A 58-year-old female patient (who was not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0171 expiry date: unknown) dose 2 via an unspecified route of administration in left arm on 29Apr2021 01:15 PM (at the age of 58-years-old), as single for Covid-19 immunization. The patient did not have any medical history. She had known allergies: hives with yellow fever vaccine 7 years prior to this re-port. Concomitant medication in two weeks included EMERGEN-C (MINERALS NOS, QUERCETIN, THIOCTIC ACID, VITAMINS NOS). The patient received first dose of BNT162B2 (solution for injection, lot number: EW0151 expiry date: unknown) via an unspecified route of administration in left arm on 08Apr2021 01:15 PM (at the age of 58-years-old), as single for Covid-19 immunization. She did not receive any other vaccine same date of suspect product or within four weeks. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 05May2021 09:00 AM, She experienced extremely strong pain and burning in legs, arms and different part of the body, pins and needles in different parts and electric shock sensation, neck lymph nodes inflammation, body temperature swings from cold to hot and the other way around. This was the second day, and she did not have relief yet. It was stated that Tylenol 500mg and Ibuprofen 200mg did not relief absolutely anything. On an unknown date, the patient was hospitalized. The patient did not receive any treatment for other events. The patient underwent lab tests and procedures included Body temperature: swings from cold to hot on 05May2021. The outcome of all events was not recovered.
58 2021-05-14 swelling Swelling feet and hands; Tingling and numbness in my entire body, in the face, arms, leggs etc/pins ... Read more
Swelling feet and hands; Tingling and numbness in my entire body, in the face, arms, leggs etc/pins and needles; Tingling and numbness in my entire body, in the face, arms, leggs etc; Migraine; Muscle pain; Tiredness; Chills; Nausea; Dizziness; Strong flue like symptoms; short breath; severe headache; tenderness/frozen arm; unable to move left arm where it was vaccinated; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm at the age of 58-years, on 14 Apr 2021 at 11:00 at a single dose at left arm for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported.no known allergies. she did not receive any other vaccines within 4 weeks prior to the COVID vaccine. it was unknown whether the patient was patient diagnosed with COVID-19 Prior to vaccination. Since the vaccination,the patient has not been tested for COVID-19. on 14 Apr 2021 02:00 PM, the patient experienced Tingling and numbness in entire body, in the face, arms, legs, unable to move left arm where it was vaccinated, migraine, muscle pain, tiredness, chills, nausea, dizziness, swelling feet and hands. She also felt flue like symptoms, tenderness/frozen arm, tingling and numbness all over the body even face, mouth. Like pins and needles, swelling hands and feet, short breath, dizzy, nausea, severe headache. There was no treatment received for the events. The outcome of events migraine, muscle pain, tiredness, chills, nausea, dizziness, swelling feet and hands Was not recovered; whereas the outcome of other events was reported as Recovered/Resolved with Sequel. No follow-up attempts are needed. No further information is expected.
58 2021-05-16 lymph node swelling I was released a bit early from the drive through, driving on the way home my soft palate/back of mo... Read more
I was released a bit early from the drive through, driving on the way home my soft palate/back of mouth started swelling making it hard to swallow?soon my lymph glands on my neck swelled. Thinking it was an allergic reaction, I took my Allegra and nose spray flonase. As the day went on, both decreased but didn?t leave until 24 hours but neck lymphs still slightly swollen today. Very scary, and there was no one to contact after from the site.
58 2021-05-17 swelling face This is a spontaneous report from a non-contactable consumer (patient). A 58-years-old female patien... Read more
This is a spontaneous report from a non-contactable consumer (patient). A 58-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Apr2021 16:45 (Batch/Lot Number: EN0161) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took lisinopril and experienced allergy. After getting shot about 1/2 hr later tongue on right side started going numb and right side of face started to swell on 16Apr2021 17:30. Therapeutic measures were taken included steriods and antihistamine. Patient visited doctor or other healthcare professional office/clinic visit for events. Outcome of events was recovered. No follow-up attempts are possible. No further information is expected.
58 2021-05-17 swelling After the first injection I experienced hot redness around the bridge of my nose which I just though... Read more
After the first injection I experienced hot redness around the bridge of my nose which I just thought may be irritation from wearing procedure masks at work. After the second dose, the redness and heat spread to my cheeks and forehead (More dominant on the left side of forehead). this was accompanied by some swelling around the eyes and bridge of nose. It gets worse later in the day, around 3pm and feels like my head is burning. I also experienced gum pain on the bottom right. I did a course of Prednisone and a course of Penicillin- prescribed by my dentist. Neither changed it at all. I am now putting aloe on my face twice a day and have just begun a course of Chinese herbs. The aloe is soothing but not changing the redness. It is too soon to tell if the herbs are helping as I just began that course of treatment yesterday. I am also trying acupuncture to relieve the heat in my face but have just started that as well.
58 2021-05-18 lymph node pain, lymph node swelling Swollen lymph node, very tender, moves when pressed, at collar bone on right hand side of body
58 2021-05-18 swelling 45 minutes after getting the vaccine I couldn't stand. My right leg felt like it was being sawed off... Read more
45 minutes after getting the vaccine I couldn't stand. My right leg felt like it was being sawed off from my hip. The pain would change from my foot, hand, etc. It also caused me to be horribly inflamed. I was red and swelled for 2 weeks. For 3 days the pain was so bad, I wanted to go to urgent care. I am very scared about the second vaccine.
58 2021-05-19 peripheral swelling my left hand and my foot swell; my left hand and my foot swell; my entire body hurts; I had the temp... Read more
my left hand and my foot swell; my left hand and my foot swell; my entire body hurts; I had the temperature almost like I got the flu; my head is really hurting; I feel disoriented; I am cold but like I am hot really hot. I felt like I am burning up; This is a spontaneous report from a contactable consumer or other non hcp. A 58-year-old female patient received BNT162B2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 (Batch/Lot Number: EW0160; Expiration Date: 31Aug2021) as 2nd, single dose for covid-19 immunization. Medical history included ongoing diabetes mellitus, ongoing thyroid disorder. The patient's concomitant medications were not reported. The patient stated "I take medicine for diabetes. I take thyroid medication. I have been taking the medication for the past, it's been some years now." The patient previously took BNT162B2, dose 1, on an unspecified date. On 07May2021 the patient experienced my left hand and my foot swell, my entire body hurts, i had the temperature almost like i got the flu, my head is really hurting, i feel disoriented, i am cold but like i am hot really hot. i felt like i am burning up. The patient stated that "I take Tylenol, I work for the government. A lot of medical workers do. A nurse said you take Tylenol . So, that's what I have been taking but it is not working." The outcome of the events were unknown. No follow-up attempts are possible. No further information is expected.
58 2021-05-19 peripheral swelling my left hand and my foot swell; my left hand and my foot swell; I had the temperature almost like I ... Read more
my left hand and my foot swell; my left hand and my foot swell; I had the temperature almost like I got the flu; my head is really hurting; Body hurting; I feel disoriented; it is not working; It started in the area where they shot me and then it became my entire arm and then my whole body just hurt though; I am cold but like I am hot really hot. I felt like I am burning up; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 07May2021 (Batch/Lot Number: EW0160; Expiration Date: 31Aug2021) as second dose single for COVID-19 immunization. Historical Vaccine of BNT162B2 was received as a first dose on an unspecified date. Medical history included diabetes mellitus, infectious thyroiditis from an unknown date and unknown if ongoing. She stated, takes medicine for diabetes and thyroid medication. I have been taking the medication for the past, it's been some years now. Concomitant medications with paracetamol route of administration, start and stop date were not reported for an unspecified indication. The patient experienced my left hand and my foot swell (hand swelling and swelling of feet), had the temperature almost like she got the flu, my head is really hurting, body hurting, she felt disoriented, it is not working, it started in the area where they shot me and then it became my entire arm and then my whole body just hurt though, I am cold but like I am really hot. I felt like I am burning up on an unspecified date. Consumer stated, she took Tylenol, and she work for the government. A lot of medical workers do. A nurse said you take Tylenol. So, that's what I have been taking but it is not working. She stated, there was no need to have any treatment. I got the vaccine. I came home. I lay on the bed yesterday when I left there so, it was just started hurting. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
58 2021-05-19 sepsis 3/18, admiteed 2 days after covic vaccine with SOB, rib pain, emesis. Patient had metastatic ovarian... Read more
3/18, admiteed 2 days after covic vaccine with SOB, rib pain, emesis. Patient had metastatic ovarian cancer on chemotherapy who was admitted to the intensive care unit with severe sepsis with septic shock and acute hypoxemic respiratory failure requiring intubation mechanical ventilation. She was started on broad-spectrum antibiotics, but did not have an obvious source of infection. She remained on mechanical ventilation, with profound metabolic acidosis. She required high doses of norepinephrine and vasopressin drips, but on arterial blood gas had a pH of 6.98. The patient had a cardiopulmonary arrest in the intensive care unit. 1 round of ACLS protocol was performed, with return of spontaneous circulation. After discussion with the patient's mother by phone, she opted for DNR status, comfort care, and to allow for natural death. The patient was kept on mechanical ventilation, and she passed away.
58 2021-05-19 swelling pt states she got very nauseated immediately after taking the covid vax. She has had joint pain, vo... Read more
pt states she got very nauseated immediately after taking the covid vax. She has had joint pain, vomiting, fatigue, fever, and chills. She got a burning sensation in her eyes and poor vision. She had a tele-visit w/ her PCP about 7 days after getting vax. She was told to take Tylenol 500 up to 8000mg for the pain, but the amount of meds has hurt her stomach. She still had these symptoms and got the 2nd dose on 4/17/2021 in the right arm. Her symptoms got worse. She had to stop working due to the joint pain in her leg, arm, and shoulder. She feels like something is swollen on the right side of her body in her ear and her throat. She is having heart palpitations and breathing differently. She has had blood work and still waiting on the results. She had a negative Covid Test. She is still in alot of pain and she feels like it has changed her whole life. She is no longer a happy person as it has affected her mood.
58 2021-05-20 lymph node swelling Swollen lymph node right clavicle
58 2021-05-21 oral herpes, swelling face severe allergic reaction; difficulty breathing; swelling of face and throat; swelling of face and th... Read more
severe allergic reaction; difficulty breathing; swelling of face and throat; swelling of face and throat; fast heartbeat; a bad rash all over the body; dizziness; weakness; pain at injection site on left arm/left arm started hurting; tingling hot pins all over; tingling hot pins all over; nausea; swelling on opposite shoulder on the right; back pain; chest pain; a cold sore on her lip; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that side effects began on 27Feb2021. Side effects included tingling hot pins all over, nausea, pain at injection site on left arm/ left arm started hurting, swelling on opposite shoulder on the right, back pain, chest pain and a cold sore on her lip. She went to the doctor a couple times and reported to her doctor that all her symptoms stopped on 04May2021. She was scheduled to go back to the doctor on 14Jun2021 and they are going to test her for antibodies. She would like to know since her side effects lingered for so long, if she should receive the second dose? She wants to receive the vaccine and be fully vaccinated but she doesn't want to go through this all over again. Everyone in her family was vaccinated and they did not have any side effects. Her doctor didn't want to tell her yes or no if she should receive the second dose. After reading the severe allergic reaction side effects that include difficulty breathing, swelling of face and throat, a fast heartbeat, a bad rash all over the body, dizziness and weakness, the patient stated that she has all of those side effects in the middle of the night and worse. Her doctor told her that a lot of stuff happened to her and it lingered for so long in a person that doesn't usually have reactions so she should hold off and mask up and social distance and come back for her appointment in June where she will be tested for antibodies. Her doctor did blood work and took pictures and made a report and told her to call and make a report as well. Outcome of the events was recovered on 04May2021. Follow-up attempts are needed. No further information is expected.
58 2021-05-23 c-reactive protein increased Patient previously healthy, developed Graves disease via lab testing 4/16/21, is also undergoing wor... Read more
Patient previously healthy, developed Graves disease via lab testing 4/16/21, is also undergoing workup for thyroid nodule, also had significantly elevated LFTs but it is unclear of cause for this, they have been down trending.
58 2021-05-23 lymph node swelling Extreme pain and swelling in armpit. Pain in groin, hip, leg (all on vaccine side). Hot flashes and ... Read more
Extreme pain and swelling in armpit. Pain in groin, hip, leg (all on vaccine side). Hot flashes and upset stomach.
58 2021-05-23 lymph node swelling I waited 30 minutes after the shot, then left the building to head home. About 10 minutes after that... Read more
I waited 30 minutes after the shot, then left the building to head home. About 10 minutes after that, I developed hives on face, neck, chest & arms. I had a very bad headache, swollen glands, stiff neck and some upper back and abdominal pains, slightly blurry vision. I went back to the facility and was checked out there. Was advised "not to worry" and sent home. I took Benedryl that I had brought from home which helped with the hives. Took Tylenol after coming home.
58 2021-05-24 peripheral swelling Patient received vaccine in left deltoid on 5/12/21. On 5/14/21 started to have left upper arm swe... Read more
Patient received vaccine in left deltoid on 5/12/21. On 5/14/21 started to have left upper arm swelling, pain, warmth. Had doppler done on 5/18/21that showed left brachial vein DVT. Started on Eliquis immediately At followup on 5/25/21, swelling reduced, pain and warmth resolved.
58 2021-05-24 swelling face Adrenaline rush, chills, fever, vomiting, headache, facial swelling especially around eyes. Chills ... Read more
Adrenaline rush, chills, fever, vomiting, headache, facial swelling especially around eyes. Chills & fever from 9PM to 3AM the next morning was followed by vomiting 5/11 AM. The headache and swelling lasted 4 days. 5/14/21 I was almost back to normal.
58 2021-05-25 anaphylactic reaction APPROXIMATELY 22 MIN. AFTER RECEIVING VACCINE, CLIENT BECAME LIGHT HEADED, DIZZY, SHORT OF BREATH, T... Read more
APPROXIMATELY 22 MIN. AFTER RECEIVING VACCINE, CLIENT BECAME LIGHT HEADED, DIZZY, SHORT OF BREATH, THROAT SWELLING, EYES WATERING, BLOOD PRESSURE DROPPED, TIGHTNESS IN CHEST. 911 CALLED. PARAMEDICS GAVE IV EPI. AND TRANSPORTED CLIENT TO HOSPITAL ER. MD DIAGNOSED ANAPHYLAXIS DUE TO COVID VACCINE. IN ER, CLIENT WAS GIVEN PREDNISOLONE AND ALBUTEROL TREATMENT. CLIENT RESTED IN ER WHILE BEING MONITORED. CLIENT THEN RELEASED TO GO HOME.
58 2021-05-25 swelling 2nd dose received. AFter a few minutes, patietn reporting "fuzzy lip" sensation. No swelling, angioe... Read more
2nd dose received. AFter a few minutes, patietn reporting "fuzzy lip" sensation. No swelling, angioedema, chest pain, shortness of breath, tongue swelling, airway obstruction or difficulty speaking or diaphoresis. No issues with 1st dose. Monitored for 30 minutes. Symptoms improved/resolved and patient was discharged from clinic.
58 2021-05-26 lymph node swelling Low grade fever; Chills; Achy; Swollen lymph nodes; Headache; Blisters on my tongue; Tired; This is ... Read more
Low grade fever; Chills; Achy; Swollen lymph nodes; Headache; Blisters on my tongue; Tired; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: not reported), via an unspecified route of administration, administered on left on 27Jan2021 (at age of 58-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient has not received vaccine in four weeks. The patient has not received other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19 .The patient concomitant medications were not reported. The patient had known allergies and had Reaction to Codeine 30 years ago. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: not reported) via an unspecified route of administration 06Jan2021 at 08:30 AM (at age of 58-year-old) on right arm at single dose for COVID-19 immunization. On 28Jan2021 at 01:00 PM, the patient experienced Low grade fever, chills, achy, swollen lymph nodes, headache, tired and blisters on tongue. Th events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was recovered. Information about lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no fur-ther information is expected.
58 2021-05-26 lymph node swelling Developed high fever night of obtaining 2nd vaccine that got as high as 103. Swollen lymph nodes and... Read more
Developed high fever night of obtaining 2nd vaccine that got as high as 103. Swollen lymph nodes and glands lasted for 2 days. Three days later, tremors feeling possible seizure but did not have one. Additionally stated to have muscle spasms, weakness and muscle contractures mainly right side extremities and lower back and pelvis area started. The muscle spasms have continued to occur just not every day any more. I had muscle spasms in my leg last night so would not say all symptoms have resolved yet.
58 2021-05-26 peripheral swelling shingles; couldn't sleep; limping; arthritis is acting up/ throbbing, aching, tightening, and painfu... Read more
shingles; couldn't sleep; limping; arthritis is acting up/ throbbing, aching, tightening, and painful; pain is in one leg in the thigh; leg was swollen and painful and spread up to her hip; muscle spasms in her legs; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 28Apr2021 09:00 am (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included ongoing diabetes had for about 6-7 years, ongoing arthritis patient has had for years, started when she was little; family medical history included her dad had rheumatic fever and high blood pressure. Concomitant medication(s) included ongoing metformin taken for diabetes. Patient was borderline due being overweight, if she lost weight it would probably go away. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No additional Vaccines Administered on Same Date of the Pfizer Suspect other than the first dose. Prior Vaccinations (within 4 weeks) was none. Patient received first shot on 02Apr2021 8:40 am (Lot: EP7334) in left arm for covid-19 immunisation. It was noted that with the first shot, there was pain and it turned red at the injection site that last 6 days and then that went away. She took Tylenol and hot water in the shower to treat this event. Caller reported that the first dose just swelled her arm. Expiry and NDC are unknown for both shots. The patient experienced arthritis is acting up/ throbbing, aching, tightening, and painful; pain is in one leg in the thigh; leg was swollen and painful and spread up to her hip and muscle spasms in her legs on 29Apr2021, shingles, couldn't sleep and limping on an unspecified date. Caller stated that she had both doses of the vaccine. Agent called back to verify that the doses were the Pfizer covid 19 vaccine and the date of the second dose. Caller stated that her second dose of the Pfizer covid 19 vaccine was on 28Apr2021. Caller reported that after the second dose she was diagnosed with muscle spasms in her legs by one doctor and the ER doctor told her that her arthritis is acting up. Caller stated it felt like she got the second shot in her leg. Caller reported that the pain is in one leg in the thigh on the side that she got the shot on. Caller stated her doctor wants her to go to a neurologist thinking it could be shingles. Caller stated the doctor called a medication in for her for shingles. Caller stated she was using the heating pad and taking flexeril and neurontin. Caller stated she has not gotten any sleep. Caller stated she missed work yesterday and today. Caller stated she has pain in her legs and wanted to know how long that will last. Caller, reporting on the Pfizer COVID shot, and who explained that after getting the shot her leg started acting up the next morning. She explained that it has been throbbing, aching, tightening, and painful. She went to the emergency room and they told her they think is it is her arthritis; that the shot irritated and made it worse. She was given a shot, they thought maybe it startd with a T or like Tylenol, but it was something for pain. They wanted to give pain medication to take with her but she refused; told them she would just do Aleve and Tylenol. She still got no relief so she went to her medical doctor and they told her it was muscle spasms, the nurse said she could feel a knot. They treated it and that didn't help. Finally her doctor gave her Neurontin yesterday. She has been taking that since 12 noon yesterday through today and she will say it is getting better explaining that she hasn't able sleep but now can get cat naps. Caller reported she is a caretaker, like a medical assistant. She had been missing days from work because of this. The doctor was going to try and find her a specialist, a neurologist. When asked Primary / Prescribing Healthcare caller stated she saw in the emergency room and as a medical doctor because her normal primary care doctor retired. She didn't have contact details for either of these doctors. The shot was given by some people. It was clarified that this was after the second shot. The second shot was on 28Apr2021. She explained she was limping cause it hurts so bad, ever since she got the second shot. Neurontin was started yesterday and since starting it she is better, she was able to sleep some where she couldn't sleep before. Caller reports the product is in a pharmacy bottle with the NDC: 65862-0523-05. Name and NDC captured as provided by the caller. When asked about the products taken that didn't offer relief, everything prior to the Neurontin the caller only had the Flexeril bottle handy. She didn't have the name of the medication, the shot given in the emergency room and didn't want and pain medication from there because she didn't want to get hooked on pain pills. She also took Aleve and Tylenol. Gave her Flexeril, on 06May2021 it was filled. It is in a pharmacy bottle, no manufacturer, Lot or Expiry, NDC: 48547-0400. There are little number and hard to read but confirmed it is in pharmacy bottle. Treatment: she did have blood work but was told her cholesterol and everything was fine, everything was good. AE(s) required a visit to emergency room on 02May2021. And resulted in physician office, doctor on 10May2021. AE(s) following prior vaccinations was none. Caller received her second dose of the covid-19 vaccine and the next day woke up and her leg was swollen and painful and spread up to her hip. Caller went to the emergency room and was given medication which she states helps a little. Investigation included blood test with unknown result on unspecified date. The event outcome for all events was unknown.
58 2021-05-26 swelling face 30 minutes later, facial swelling, dizziness. No symptoms with second injection
58 2021-05-27 lymph node swelling I can't eat; can talk now unlike before; Vomiting; Nauseated; I had a Bell's palsy after the vaccine... Read more
I can't eat; can talk now unlike before; Vomiting; Nauseated; I had a Bell's palsy after the vaccine; temperature happened; body ache; My lymph nodes are swollen; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (Pfizer COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in left arm on 08Jan2021 (Lot Number: EL1283) as single dose for COVID-19 immunization. Medical history included hypertension, asthma and gallstones from an unknown date and unknown if ongoing. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. The patient previously received 1st dose of bnt162b2 (Pfizer COVID-19 vaccine), via an unspecified route of administration, administered in left arm on 21Dec2020 (Lot Number: EH9899) as single dose for COVID-19 immunization. Second dose was on 08Jan2021 and then after that, the patient had those like lower mouth pain, experienced a headache and the temperature and the body ache and everything all happened. Lymph nodes are swollen already and so patient went to doctor and they gave Augmentin (treatment) on 17Jan2021. The patient saw how her face was looking, she had a Bell's palsy after the vaccine. She didn't worked since January until the time of report because of so many tests that she did and have spent a lot of money already. She was depressed for how many months and can't eat and face has droop and eyes was hurting a lot, it is kind of emotional thing and spending a lot of money already on tests and everything. Still experiencing Bell's palsy, still have some droop in face but can talk now unlike before but every time she talks there is saliva coming out in left face. For the treatment of events: they gave Augmentin, that is the antibiotic, the tablet, 3 times a day. The other one is Valtrex, 1 gram, three times a day also. There is another one, it is Medrol, one tablet three times a day. Also, as patient was having the headache that time, taking (not clear) two tablets every six hours. Anti-nausea over the counter medicine as needed because of vomiting and nauseated always that time. The Medrol they gave twice on that time after she finish the first Medrol, they gave her Prednisone three times a day also. Outcome of event Bell's palsy was not recovered, for event can talk now unlike before was recovering, for the other events was unknown.
58 2021-05-28 swelling face Pfizer=BioNTech COVID-19 Vaccination. about 25 minutes post shot thru 45 minutes post shot, very red... Read more
Pfizer=BioNTech COVID-19 Vaccination. about 25 minutes post shot thru 45 minutes post shot, very red slightly swollen face, pinching paind in left wrist/hand. Then on 4/20 thru 5/21m extremely achey thru upper back down both arms thru hands, more on left side. Diarrhea on morning of 5/29. No fever or chills as of 5/29
58 2021-06-01 lymph node swelling headache; sore throat; red bumps on the upper roof of my mouth; problems with swallowing; my glands ... Read more
headache; sore throat; red bumps on the upper roof of my mouth; problems with swallowing; my glands were also swollen; scratchy throat; problems with swallowing (hurt); This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 07:00 (Batch/Lot Number: EN6203) as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took codeine and experienced drug hypersensitivity. No other vaccine in four weeks was given to patient. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. It was reported that on 25Mar2021, the patient started with a headache, in which she took tylenol then shortly thereafter she had a scratchy throat, sore throat and problems with swallowing (hurt), this continued throughout the day and into the evening. The next day same thing but she also noticed red bumps on the upper roof of my mouth, and noticed her glands were also swollen. Therapeutic measures were taken as a result of headache (headache). The outcome of the events was reported as not recovered. Information on lot/batch number has been requested. Follow-up (12May2021): Follow-up attempts completed. No further information expected.
58 2021-06-01 swelling Severe swelling and armpit pain on injection side; Severe swelling and armpit pain on injection side... Read more
Severe swelling and armpit pain on injection side; Severe swelling and armpit pain on injection side; severe hip pain; overall pain and tingling in left side; overall pain and tingling in left side; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 05Apr2021 at 16:45 (at the age of 58-years-old) as 2nd dose, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included rosuvastatin (ROSUVASTATIN), vitamin c [ascorbic acid] (VITAMIN C) and vitamin d [vitamin d nos] (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient previously took bactrim and experienced drug hypersensitivity. The patient previously received first dose of BNT162B2 (Lot number was unknown), via an unspecified route of administration in arm left on 05Apr2021 at 16:45 for covid-19 immunization. On 29Apr2021 at 15:45, the patient experienced severe swelling and armpit pain on injection side, severe hip pain on injection side, overall pain and tingling in left side. The reporter classified the events as non-serious and stated the events result doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
58 2021-06-02 oral herpes, c-reactive protein increased chills and achiness 3 days after vaccine. New fevers starting 4/28/21 along with fatigue and malaise... Read more
chills and achiness 3 days after vaccine. New fevers starting 4/28/21 along with fatigue and malaise. Symptoms of fever and malaise lasted about 2 weeks. Oral cold sores developed after fever.
58 2021-06-03 peripheral swelling Severe muscle spasms and seizing. Was caught by surprise with the onset and off balance and ended up... Read more
Severe muscle spasms and seizing. Was caught by surprise with the onset and off balance and ended up falling into a wall and broke my arm. now have to have surgery. Also entire arm swollen and black and blue.
58 2021-06-07 guillain-barre syndrome This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0171), via an unspecified route of administration on 28Apr2021 as 1st dose, single dose for COVID-19 immunization. Medical history included immune deficiency 2 months prior in 2021. The patient's concomitant medications include unspecified medications that the patient has been taking "forever". The patient did not start any new medications recently. She did not have any other vaccinations the same day as the Pfizer COVID-19 vaccine or in the four weeks prior. She says she hadn't had a vaccine in years. The patient reported that she got the vaccine then went grocery shopping and felt great, her arm didn't even hurt, and she didn't feel the shot going in. She says she went to bed and got up 4:00AM to get ready for work, and as soon as her alarm went off on 29Apr2021 she felt really weird. On 29Apr2021, she went to stand up and went to her knees since she couldn't walk and had to crawl to the bathroom. She was in the worst pain in her life/pretty bad pain. Her body was cramping. She was having cramps to her legs and just like every muscled from her foot to her hips and in her hips were cramping, severe cramping, the whole leg. She says she lost feeling and still has some numbness. Patient says her brain is a little foggy as well. The patient took pain medications and Neurontin which is helping her numb feet and tingling in extremities. She also had an icy feeling in her legs, though they are warm always although they feel icy, if she touches them they are warm, like normal body temperature. Patient clarified Neurontin as gabapentin 300 mg, says the doctor has started her out one at night before bed, and she just was given it, so she has only taken two days of it. She says they wanted to see how it affected her, and wanted her to call so they could decide how much to give her, so they started her at the lowest place. She says it didn't effect her worse than she already was, but she thinks they were holding off to see what the neurologist came up with too. The patient also had a little incontinence of bowel and bladder on an unspecified date in 2021. She says she went to the emergency room the day she woke up with the adverse reaction, on the "29th". She says that they gave her Morphine IV. She says that they did no tests, or blood tests, then they sent her home with pain meds and said that this will probably get worse before it gets better, and to follow up with her doctor. She says she followed up with her doctor the next morning. She says that the pain meds made her sleepy, but did not take care of the pain. She says that she went to see her doctor, who sent her to a different hospital, and there she was admit from emergency. She was given an unspecified muscle relaxer which was the one she threw out, her pain wasn't muscle, it was nerve, so she threw it out. She was given Hydrocodone, substituted for Norco. They also gave her, maybe a Tramadol pill, in the hospital. She says she spent 7 days in the hospital, had two ER visits, and doctor visits. The patient underwent lab tests and procedures which included antinuclear antibody: positive 2 months prior in 2021. The patient had her "proteins" tested which were good and also did a spinal tap and were still good in her fluid both on an unspecified date in 2021. The other neurologist wanted to do an EMG (not yet done), because sometimes it can still be fine and not higher proteins. She says mostly they have been going by her symptoms. She has not been diagnosed yet with Guillain-Barre, since she still needs to see a neurologist for the conduction study. She added she will consult with her neurologist, continue to take her Neurontin, and have the physical therapy. The outcome of the events was unknown.
58 2021-06-07 lymph node swelling, swelling face Site pain; tiredness; mild headache; muscle pain; chills; fever; not well; swollen lymph nodes; swol... Read more
Site pain; tiredness; mild headache; muscle pain; chills; fever; not well; swollen lymph nodes; swollen face; aching; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on 08Mar2021 15:00 (at the age of 58-years-old) as unknown, single dose for COVID-19 immunisation. Medical history included COVID-19 (prior to vaccination) and Penicillin allergy; both from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) and vitamins (taken by the patient every day); both taken for an unspecified indication, start and stop dates were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient was not tested for COVID post vaccination. On 09Mar2021 12:00 PM, the patient experienced site pain, tiredness, mild headache, muscle pain, chills, fever, not well, swollen lymph nodes, swollen face and aching. No treatment was taken for the events. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
58 2021-06-07 peripheral swelling patient called to report that her feet is swollen for a couple days
58 2021-06-08 peripheral swelling tingling; numbness; Feels little lumps and bumps in her arm; dull pain in the upper arm. Is probably... Read more
tingling; numbness; Feels little lumps and bumps in her arm; dull pain in the upper arm. Is probably the worst around the elbow and goes all the way down into the hand and thumb,; This is spontaneous report received from a contactable Nurse (Patient). A 58-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Lot Number: EN6204), via an unspecified route of administration on 10Mar2021 at 12:00 (at the age of 58-year-old) as 2nd dose, single dose in left arm for COVID-19 immunization at hospital. The patient's medical history included COVID-19 from Dec2020, as she actually got COVID virus over Christmas. Concomitant medications were not reported. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Lot Number: EN6200), via an unspecified route of administration on 17Feb2021, as single dose in left upper arm for COVID-19 immunization. The patient's historical vaccine included flu vaccine in October, which was the last vaccine she received. On an unspecified date in Mar2021, within a week or two, the patient experienced symptoms that mimicked radiculopathy, where you have a nerve situation that moves down the arm into the fingers, causing tingling and numbness, in the thumb. Patient thought it was maybe thoracic outlet syndrome. Patient experienced dull pain in the upper arm, probably the worst around the elbow and goes all the way down into the hand and thumb and has tingling and numbness. Tingling and numbness continued for a while, tingling comes and goes, but numbness was constant. Dull pain worsened when she was not using her arms, which was strange for radiculopathy. Typically, movement would make it worse. When her arm was still, while watching television or during her sleep, it woke her up. But was almost better while cleaning the house. Patient could feel the declination and was getting worse than before. Patient visited Physician's office, saw surgical physician, and told him about dull pain, tingling and numbness. He ordered a CT scan and some X-rays. Patient assumed a possibility of clot, not deep vein thrombosis or anything. Patient felt like little lumps and bumps in her arm and does not know if it was because of age or what was going on. Treatment medication included Tylenol and ice. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: positive, on an unspecifies date. The clinical outcome of the event dull pain in the upper arm, probably the worst around the elbow and goes all the way down into the hand and thumb, was not resolved. The clinical outcome of all other events was unknown. Follow-up attempts needed. Additional information has been requested.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events and the administration of the vaccine cannot be excluded.
58 2021-06-08 white blood cell count increased 06/08/2021-Received vaccine at Urgent Clinic. Pt found down at home. Brought to Hospital ED, with c... Read more
06/08/2021-Received vaccine at Urgent Clinic. Pt found down at home. Brought to Hospital ED, with cardiac arrest (STEMI), where she later died.
58 2021-06-09 swelling About 6 hours post vaccine, I woke up with fever, chills and shaking. I took ibuprofen and Tylenol ... Read more
About 6 hours post vaccine, I woke up with fever, chills and shaking. I took ibuprofen and Tylenol . I could not go to work and stayed home. These symptoms lasted about 48 hours. About a week after the vaccine, I started having angioedema. I notice my tongue started to swell. I also noticed my lips and the inside of my mouth was swelling too. It would start from the left inside of my mouth and migrate to the right side. I took Benadryl. The swelling lasted for about 4 days and started to slowly go away. About a week later, I started getting body rashes on random parts of my body. It had it on my ears, underarms, under my breasts, thighs, hands, legs and trunk. The rash would randomly appear and dissapear and could last from 12 hours to several days. I went to se a doctor and was prescribed Allegra, Zyrtec and steroids. I got another 2nd opinion with Dr and got blood work done. I still am suffering from random rashes and notice it will flare up when I don't take my antihistamine medications. The rash is very red, blotchy, can be raised, itchy, painful and very uncomfortable. I never know when I would get them or how severe it may be.
58 2021-06-09 swelling face 3-25-21 approx(pt unsure) lump on collar bone. Left sided of face swollen around week three. after 2... Read more
3-25-21 approx(pt unsure) lump on collar bone. Left sided of face swollen around week three. after 2nd dose lump behind the ear. Had sonogram done and was told it was an infected salivary gland.
58 2021-06-10 swollen extremities, systemic inflammatory response syndrome N17.9 - Acute kidney failure, unspecified R65.10 - Systemic inflammatory response syndrome (sirs) of... Read more
N17.9 - Acute kidney failure, unspecified R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction VOMITING PERIPHERAL EDEMA
58 2021-06-11 sepsis Severe Pneumonia; Sepsis; This is a spontaneous report from a contactable consumer (patient). A 58-y... Read more
Severe Pneumonia; Sepsis; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 14:00 (Batch/Lot Number: EW0750) as 1st dose, single for covid-19 immunisation. Medical history included asthma and GERD (gastrooesophageal reflux disease). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously took pencillin and sulfa [sulfanilamide] both which patient experienced allergies. On 28Apr2021, the patient experienced severe pneumonia and sepsis with symptom of fever which began around 29Apr2021. The events required hospitalization from 05May2021 to 09May2021. The patient was treated with IV and oral antibiotics, oxygen and breathing Tmt. The patient underwent lab tests and procedures which included nasal swab on 26Apr2021 which result was negative. The outcome of the events was recovering. Follow up needed, further information has been requested.
58 2021-06-16 lymph node swelling Swollen Lymph node in right armpit
58 2021-06-17 peripheral swelling Approximately 10 days after I received my second COVID vaccine (Pfizer) my index fingers and thumbs ... Read more
Approximately 10 days after I received my second COVID vaccine (Pfizer) my index fingers and thumbs in both hands became very swollen. The swelling continued to ebb and flow over the next couple of weeks and often included swelling and inflammation in all my fingers and hand joints/knuckles, my left ankle, left toes, left elbow. As of today (6.18.2021, my left index finger is still very swollen and painful with limited mobility and more minor swelling/inflammation is still present in all my fingers, some of my left toes, my left elbow and left ankle.
58 2021-06-17 swelling face She has been afraid to get her second dose; sweating like she is in the sauna; Dizziness; Weakness; ... Read more
She has been afraid to get her second dose; sweating like she is in the sauna; Dizziness; Weakness; Difficulty breathing; couldn't hardly talk, had to whisper; fast heart beat; swelling of throat; shaking really bad; swollen face; she feels hot like she's in a sauna; severe allergic reaction; This is a spontaneous report from a contactable consumer or other non-health care professional. A 58-years-old female patient received bnt162b2 (BNT162B2solution for injection, Batch/Lot number was not reported) via intramuscular route of administration and administered in left arm on 23Apr2021 12:00 as single dose for COVID-19 immunization. The patient didnt had any another vaccines on 23Apr2021. The patient didnt had any another medications prior four weeks. Medical history included angina pectoris from 2006 and ongoing She takes Diltiazem 180mg once daily by mouth. She has been on it for years. Concomitant medications included diltiazem (DILTIAZEM) taken for angina pectoris. On 23Apr2021 at 12:00 patient had a severe allergic reaction to the Pfizer Covid-19 vaccine. Her side effects were difficulty breathing, difficulty swallowing, fast heartbeat, dizziness, weakness, and she feels hot like she is in the sauna. Confirmed details with caller, who said she did not have difficulty swallowing, but did have swelling of her throat and couldn't hardly talk, she had to whisper. She also said she was sweating like she was in the sauna instead of she feels hot like she is in the sauna. Immediately after the Covid-19 injection she had all these symptoms. Within two hours she was completely back to normal. Her mom came to get her in a wheelchair because she was shaking really bad. She used a wheelchair which was provided to her by them. This occurred half an hour after the injection. An emergency medical technician (EMT) came and the caller's symptoms started to dissipate by the time they got there. She said they took her vitals and was told that they were all fine. She does not remember what vital signs were taken or what the results were. She did not get nothing after getting the vaccine for her side effects. The EMT was going to give her an epi-pen but she declined it. She did not take anything for her symptoms. Caller thought she was supposed to wait a month, which was a couple of days ago. She was listening to the automatic thing and was told she was supposed to wait three weeks. She has been afraid to get her second dose of the Covid-19 vaccine. Her doctor said it was ok to get. caller reports that the EMT did a blood sugar test on 23Apr2021 and initially stated the result was 23. Clarified with caller result is 123. She also had her vitals taken, but does not know the results, she was so out of it. Has regular medications that she has been taking for a long time but doesn't feel that they are relevant. Caller provided no further product names. The patient underwent lab tests and procedures which included heart rate: fast, investigation, physical examination on 23Apr2021.The outcome of events was recovered and outcome of event she has been afraid to get her second dose was unknown.
58 2021-06-18 peripheral swelling Events besides flu like symptoms are arm swelling and palpitations for 3 days or more. Severe musc... Read more
Events besides flu like symptoms are arm swelling and palpitations for 3 days or more. Severe muscle pain with swelling and hardening with heat in my right upper thigh which continues to linger since the vaccine. Wakes me up at night when i'm trying to rest, it feels better upon walking around but if I sit down or lay down it bothers me. Not sure if anyone else has reported this. I have never had this pain before ( I did get the shingle vaccine 2-3 months prior to this shot so I don't know if it was an interaction).
58 2021-06-18 swelling, peripheral swelling body began to swell; Swelling in her feet; had a lot of swelling in her joints; could not walk or pi... Read more
body began to swell; Swelling in her feet; had a lot of swelling in her joints; could not walk or pick up her arms and feet.; screamed in pain; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via intramuscular in left arm on 19Jan2021 at 18:00 for COVID-19 immunization. The relevant medical history included high blood pressure & diabetes from unspecified date, allergy to penicillin from unspecified date. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of vaccination. The patient took the vaccine on 19Jan2021 and she started feeling very still on Friday, by Monday she could not walk or pick up her arms and feet. She screamed in pain and her body began to swell so she went to urgent care and had to be placed on steroids. She could not wear shoes for 3 months due to swelling in her feel and they continue to swell, so she was forced to wear compression stockings. She continued to see a rheumatologist and had to take therapy for 3 months. She was healthy before the shot, but after her body was not the same and she had a lot of swelling in her joints after the first vaccine. The events onset date was reported as 22Jan2021 at 08:00 AM. The events resulted in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab test included nasal swab showed negative in Jan2021. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering. Information on lot number/batch number was requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events swelling, peripheral swelling, joint swelling, gait disturbance and pain cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
58 2021-06-19 swelling face After the second Pfizer shot I broke out in hives all over my body, and on my corneas. The hives hav... Read more
After the second Pfizer shot I broke out in hives all over my body, and on my corneas. The hives have not totally resolved and I still have flare ups of swollen face and eyes, and itchy spots on limbs. My corneas have begun to clear up and my vision is coming back. Nothing other than prednisone addresses the allergic reaction. It flares whenever I stop taking the prednisone.
58 2021-06-20 axillary mass I don't know if this is an adverse effect or something that has just happened. I have two masses/lum... Read more
I don't know if this is an adverse effect or something that has just happened. I have two masses/lumps under my left arm (near the breast) and am going for further evaluation (mammogram and ultrasound) on June 29, 2021.
58 2021-06-22 peripheral swelling, lymph node swelling Client with left arm soreness and swelling the night of injection, woke with enlarged lymph node in ... Read more
Client with left arm soreness and swelling the night of injection, woke with enlarged lymph node in left side of neck and axillae, with nodule noted left clavicle area. Client to follow up with her PCP.
58 2021-06-22 peripheral swelling I had covid arm with swelling and rash it lasted about 4 weeks. I used hydrocortisone for rash swell... Read more
I had covid arm with swelling and rash it lasted about 4 weeks. I used hydrocortisone for rash swelling lasted approximately 4 weeks
58 2021-06-22 swelling She states that as she was walking, they felt like cement, got very heavy; arm where she got the sho... Read more
She states that as she was walking, they felt like cement, got very heavy; arm where she got the shot swelled up, was red, and pain was there; arm where she got the shot swelled up, was red, and pain was there; arms started hurting; really bad pains in her legs and feet; really bad pains in her back and side on the right side; side started hurting really, really bad; lower abdomen started hurting/ Lower abdominal pain; head started hurting really, really bad like it was going to explode; whole right side swelled up; started feeling nauseous; throat was also hurting; it was like she was dizzy; started peeing blood; Joint pain; body was aching; skin was itching; arm where she got the shot swelled up, was red, and pain was there; Sinus congestion; basically dropped to her knees. Caller states she was in so much pain; she had recently found out her son and his wife contracted the COVID vaccine/Clarified with caller that she was referring to the COVID virus.; This is a spontaneous report from a contactable consumer(patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0183; Expiration Date: Aug2021) via an unspecified route of administration, administered in Arm Left on 21May2021 12:30(at the age 0f 58-year-old) as single for covid-19 immunisation. Medical history included nephrolithiasis from 2021 and ongoing, Kidney stones, lupus-like syndrome from Nov2019 and ongoing, lupus, rheumatoid arthritis from Nov2019 and ongoing, rheumatoid arthritis, gastroenteritis radiation from Feb2019 and ongoing, chemical colitis, haematuria from 30Jan2021 and ongoing, Recurrent haematuria, arthralgia from Aug2020 and ongoing, Joint pain, ocular hyperaemia from 22Jun2020 and ongoing, Floaters in her eyes, cardiac failure, Heart failure.The patient's concomitant medications were not reported. The patient experienced she had recently found out her son and his wife contracted the covid vaccine and she clarified that she was referring to the covid virus. on 21May2021 arms started hurting, really bad pains in her legs and feet, really bad pains in her back and side on the right side, side started hurting really, really bad, lower abdomen started hurting/ lower abdominal pain, head started hurting really, really bad like it was going to explode, whole right side swelled up, started feeling nauseous, throat was also hurting, it was like she was dizzy, started peeing blood, joint pain, body was aching, skin was itching, arm where she got the shot swelled up, was red, and pain was there, sinus congestion, basically dropped to her knees and patient stated that she was in so much pain. she stated that actually is trying to reach her doctor and she couldn't take the shot on Friday, 11Jun2021, says the doctor told her not to take the shot until she could see her regular physician about everything, including the peeing incident. she wants to see her doctor and ask to see a gynaecologist, says those are things she's going to do before she takes the second shot. The patient underwent lab tests and procedures which included computerised tomogram: kidney stones. They diagnosed her kidney stones and haematuria or whatever it was about a month ago. The outcome of the events headache was not recovered, nausea was recovering and remaining events it was unknown.
58 2021-06-23 lymph node swelling About 2 days after the vaccine, I noticed enlarged lymph nodes in the left arm pit. I could not rai... Read more
About 2 days after the vaccine, I noticed enlarged lymph nodes in the left arm pit. I could not raise my arm over my head for 3 days. At day 4 post vaccine, I also noticed enlarged lymph nodes around my groin area. I consulted with the doctor via telehealth who advise to keep an eye on it and to report back if not resolved in 1 month. On 3/11/2021 I had break through menstrual bleed. It was a small amount of blood for 24 hours then it stop. I had a pap done which was normal and I have not had another episode. I followed up with my gyno. I am menopausal and have not had a menstrual cycle since 2014.
58 2021-06-23 swelling Immediate symptoms arm pain, dizziness then within an hour bad headache. Arm pain pretty bad for al... Read more
Immediate symptoms arm pain, dizziness then within an hour bad headache. Arm pain pretty bad for almost 2 weeks. Arm pain had just gotten better and I went for a routine nuclear stress test. The evening after the test I was woken by thump in my back and chest about 5 times. After waking, I would become extremely dizzy. I got up went to the bathroom each time. Every time I tried to go back to sleep I would be woken by thump again. Byy Wednesday I was in the ER with Tachycardia. Pain in left side and heart racing continued. I was in the ER again 4/30 and 5/3. I lost 10 Lbs My left side pain throughout my ribs, back, should blade and stomach distension still occurring. The left side of my back and my left breast are swollen. I have had mammogram, CT scan, ultasound and MRI's plus many visits and calls to many different specialists - heart, GI, Endocrinologist, OBgyn, and primary care doctors over the past 2 months with no answer as to what occurred. I am taking metropol for the heart racing and it has helped but the left side swelling and pain is persistent. I am not sure if this relates to the shot but maybe a combination of the 2? I do not know what happened to my body, but have never experienced anything like this before. And I had a nuclear stress test at age 40+ with no problems. My heart was fine but it was completed because of family history, lyme disease and babesia.
58 2021-06-24 lymph node pain, lymph node swelling Swollen lymph nodes; Painful swollen lymph nodes; This is a spontaneous report received from a conta... Read more
Swollen lymph nodes; Painful swollen lymph nodes; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in left arm on 03Mar2021, at 09:30 hours (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history included chronic fatigue and epstein Barr virus. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), norvasc (MANUFACTURER UNKNOWN) and acebutolol (MANUFACTURER UNKNOWN), for an unknown indication. Prior to vaccination the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination patient had not been tested for COVID-19. The patient had penicillin allergies. On 14Mar2021, the patient experienced very painful swollen lymph nodes under arm and up to shoulder (4 days after shot and not much relief). The patient did not receive any treatment for events. The clinical outcome of the events swollen lymph nodes under arm and up to shoulder and painful lymph node was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
58 2021-06-28 anaphylactic reaction Anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-p... Read more
Anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 11Jun2021 16:30 (at age of 58 years old) as single dose for COVID-19 immunization. Medical history included mast cell activation syndrome, ehlers danlos syndrome, allergic to garlic, allergic to beef, known allergies: Narcotics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included verapamil; pregabalin (LYRICA); famotidine; loratadine (CLARITINE); cromolyn sodium. The patient previously took omalizumab (XOLAIR), salbutamol (ALBUTEROL), Sorbitol, clindamycin, diclofenac diethylamine (VOLTAREN), sildenafil citrate (ZOLTAN), all had drug allergy. The patient had Anaphylaxis on 11Jun2021 03:30 PM. This case was Serious with Seriousness criteria-Life threatening. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse event (epinephrin). The outcome of the event was unknown. Information on the lot/batch number has been requested.
58 2021-06-29 lymph node swelling nausea; vomiting; left underarm lymph node swollen to about softball size; Extreme congestion; eyes ... Read more
nausea; vomiting; left underarm lymph node swollen to about softball size; Extreme congestion; eyes were sealed closed with gunk; red face; itchy face; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the left arm on 18Mar2021 at 10:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, diabetes, von willebrands, sleep apnoea, asthma and lymphedema. The patient had a history of allergy to lactose, soy, orange, tuna, salmon and environmental grass, trees and pollen. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), VICTOZA, metformin (MANUFACTURER UNKNOWN), GLIMEP for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 19Mar2021, the patient had experienced extreme congestion, eyes were sealed closed with gunk next morning, red and itchy face. On 21Mar2021 (2 days after), the patient experienced nausea, vomiting, left underarm lymph node swollen to about softball size. Therapeutic measure was taken as result of events and included treatment with methylprednisolone. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of events extreme congestion, eyes were sealed closed with gunk, red face, itchy face, nausea, vomiting and swollen lymph nodes were resolving at the time of this report. No follow up attempts are needed. No further information is expected.
58 2021-06-29 peripheral swelling From patient written report : "After my first dose, it took about 20 minutes, I felt pressure on my ... Read more
From patient written report : "After my first dose, it took about 20 minutes, I felt pressure on my chest and had a metal taste in my mouth. After an hour or so, I had a needle sensation in my hands and feet. In my left leg, it felt like electricity was shooting through my leg. It took a few weeks for most symptoms to subside. My taste is still not right, many things are now bitter. I find that my hands are still swollen. Still have a slight needle sensation in my hands and feet. My right arm where I had the shot never hurt."
58 2021-06-29 swelling, peripheral swelling I had COVID back in March 2020, and was left with long hauler syndrome. The intermittent symptoms th... Read more
I had COVID back in March 2020, and was left with long hauler syndrome. The intermittent symptoms that I still have going into the 1st dose are sore neck, exhaustion, heart racing, SOB, hair loss, hypertension, brain fog and decreased cognitive function. Start on the next day after the vaccine, my arm felt a little warm and a little sore. On day 3, at the injection site, it was raised and red about the size of a quarter and my arm was sore and swollen. No medication taken at this time. By day 7, I started getting extreme fatigue, shortness of breath, bad head ache, my neck seemed to be swelling and body aches and pains and racing heart rate. This was followed by nausea, ache and pains and low grade fever which lasted a week and starting the improved. On 3/25/2021 I went to get a COVID test as recommended by my doctor, which was negative. On 3/26/21, I got a flu test, also negative. On 3/27/2021, I got another COVID test, also negative. I also got an antibody test at a walk in clinic which was negative for COVID antibodies. Currently, I am still having mild to moderate COVID like symptoms.
58 2021-07-01 bursitis Subacromial bursitis of the right shoulder that is resolving with time and therapeutic exercise prog... Read more
Subacromial bursitis of the right shoulder that is resolving with time and therapeutic exercise program.
58 2021-07-01 lymph node swelling Sore, puffy underarm, same side that was vaccinated. Swollen lymph node.
58 2021-07-01 peripheral swelling During the week of May 24th I experienced lower chest pain. On the following weekend my left leg swo... Read more
During the week of May 24th I experienced lower chest pain. On the following weekend my left leg swole up. I went to the emergency room on the 31st and was diagnosed with a PE and DVT. I do have family history of PE, so I was tested for Leiden Factor V which was positive.
58 2021-07-01 swelling, lymph node swelling ongoing burning sensation in her throat; neck pain; left shoulder pain/lot of shoulder pain; fatigue... Read more
ongoing burning sensation in her throat; neck pain; left shoulder pain/lot of shoulder pain; fatigue/ very tired; throat was red/Throat definitely red; my left arm hurt me quite, that's where I got the injection; Both earaches bringing in the ear; sore throat; glands are starts swelling now/there is swelling gland/Swelling glands kind of feeling.; left arm hurt; With my ears I can hardly hear you asking me the last question; her vocal cords were swollen; Confused; I am still not feeling well; I feel awful; Frustration/Frustrated; she had fluid in her ear; increase in acid reflux; bilateral earache; ringing in her ear; back of her neck was swollen; This is a spontaneous report from a contactable consumer or other non Healthcare Professional. A 58-years-old female patient received first dose of BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EW0168; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Arm Left on 10May2021 (at the age of 58-years-old) as dose 1, single for covid-19 immunisation. (Reason for no lot number: of COVID-19 vaccine: Other: Consumer stated, EW O or 0 probably it's a 0, EW0168). Medical history included hypertension (Verbatim: high blood pressure), hypothyroidism, PE blood clot and DVC blood clot, hydronephrosis of left kidney, TMJ disorder. Concomitant medications included rivaroxaban (XARELTO) 10 mg daily taken for PE blood clot and DVC blood clot., start and stop date were not reported; levothyroxine sodium (SYNTHYROID) 37 and half mg taken for hypothyroidism (Under active Thyroid), start and stop date were not reported; Ongoing metoprolol 75 milligrams a day (50mg one in the morning and half in the evening 25 mg in evening) taken for High blood pressure, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Family medical history relevant to A.E: Consumer stated, No. On 12May2021, patient experienced burning sensation in her throat, neck pain, left shoulder pain/lot of shoulder pain, fatigue/ very tired, left arm hurt where the patient got the injection, both earaches bringing in the ear, sore throat, throat was red, swelling glands kind of feeling. On an unknown date in 2021, the patient experienced her vocal cords were swollen, bilateral earache, ringing in her ear, back of her neck was swollen, increase in acid reflux, she had fluid in her ear, confused, still not feeling well, feel awful, frustration, glands are starts swelling now/ there is swelling gland. The patient stated that she was getting all kind of conflicting opinions from the doctors that she has seen but always was curious as to whether, what she was dealing was a common side effect after having receive the first vaccine because she held off having the second vaccine because patient was not just feeling well since the first one and don't know what timeline is to get the second one. Patient stated that she thought there is a weekend it would be pretty much gone because I have a lot of friends as such she know it will go after two day well I went into the next week and I was still experiencing all of these things and so she now waited into the next week. Patient stated "I didn't have an appointment so I went to a sister you know of my PCP and saw one of their doctors then they said, all well we dont think its vaccine may be you have allergy take Zyrtec (Treatment), So I took Zyrtec and I took that for the entire week and then it was going into the next week and I still was not feeling well". Patient saw another Doctor and that doctor said, he checked her glands he said your glands are starts swelling. Patient was in the second week and ENT doctor "he said, well, your throat definitely red and so he like, go home and gargle with water but anyways then I saw two other doctors. I saw ENT. I had week because ENT people had long schedule that going to wait your turn so I had waited out. All ENT they looked into my throat they didnt see anything, terrible going on they looked into my ears and said, your ears are clear and then I reached out again another week with that like, I am now like six weeks into this". Patient underwent lab tests which included antibody test: reactive on 14Jun2021. Therapeutic measures were taken by the patient as a result of her vocal cords were swollen included Zyrtec and took medication for 9-10 days but it didnt help so I quit and one time the patient mentioned. Patient stated, The Ibuprofen, I took was 200mg each tablet. Patient took two mortin tablets 200mg each from over the counter and one dose of Tylenol 500mg for pain. Patient stated that "ibuprofen I only took one dose for that one time I took that on 15th that was the first time I took Motrin since the vaccine I don't usually take Motrin because I am not suppose to take it. I had blood, I had blood clot, PE blood clot and DVT blood clot. So, I dont take Motrin very often." Patient queried whether its okay to get the vaccine you know, past the time line, "because I am at 6 weeks now". Consumer stated she was at 6 weeks now and just didnt know what she should, still getting the second dose or not, because she didnt know if she was out of that window time where it's safe to get it. When informed about the Medical Information Department, consumer stated, With my ears I can hardly hear you asking me the last question. Consumer hung up the call. So no further probing including pharmacy details and treatment details could be done. Hence limited information available over the call. The outcome of the events, ongoing burning sensation in her throat, , neck pain, left shoulder pain, fatigue/ very tired, left arm hurt, bilateral earache, ringing in her ear, back of her neck was swollen, neck pain, left shoulder pain/lot of shoulder pain, fatigue/ very tired, my left arm hurt me quite, that's where I got the injection, Both earaches bringing in the ear had not recovered. The outcome of the events, her vocal cords were swollen, increase in acid reflux, throat was red/Throat definitely red, she had fluid in her ear, sore throat, glands are starts swelling now/there is swelling gland/Swelling glands kind of feeling, Confused, I am still not feeling well, I feel awful, Frustration/Frustrated, left arm hurt, With my ears I can hardly hear you asking me the last question were unknown. Information on Lot/Batch number was available. Additional information has been requested.
58 2021-07-05 swelling My back swelled up and was covered with hives and welts. I couldn't lift anything. Several episode... Read more
My back swelled up and was covered with hives and welts. I couldn't lift anything. Several episodes of severe chest pain, I thought it might be a heart attack at first. Exhaustion and not feeling well for about 4 weeks after the shot. Still having diarreha, not sure if it's from the shot or my IBS but I wasn't having it prior to my 2nd dose.
58 2021-07-06 lymph node swelling, lymph node pain Rash over torso, underarms and on chest. Visited dermatologist for steroid cream to treat. Also p... Read more
Rash over torso, underarms and on chest. Visited dermatologist for steroid cream to treat. Also painful swollen lymph nodes under arm where vaccination was received.
58 2021-07-07 peripheral swelling, swelling 3 days after 1st shot, I had had swollen joint on my right thumb, it lasted for 3 days, then I had ... Read more
3 days after 1st shot, I had had swollen joint on my right thumb, it lasted for 3 days, then I had keen pain , lasted for a day. No treatment.
58 2021-07-07 peripheral swelling Headaches, my fingers swell up
58 2021-07-08 lymph node swelling Swollen lymph node over collar bone; This is a spontaneous report received from a contactable consum... Read more
Swollen lymph node over collar bone; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 17Mar2021 at 14:15 hours (at the age of 58-years) as a single dose for COVID-19 immunisation. Medical history included chronic inflammation and COVID-19 from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medications included low dose naltrexone (MANUFACTURER UNKNOWN) and esomeprazole magnesium (NEXIUM) received medications in two weeks. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccination. On 20Mar2021 at 08:00 hours, the patient experienced swollen lymph node over the collar bone. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event swollen lymph nodes was resolving at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
58 2021-07-08 lymph node swelling stabbing pain in eye; stye forming; ulceration under eyelid; pinky toe; Headache; Earache; Swollen g... Read more
stabbing pain in eye; stye forming; ulceration under eyelid; pinky toe; Headache; Earache; Swollen gland in neck; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non pregnant female patient received the first dose BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot no: EN6203) via an unspecified route of administration in the left arm on 06Mar2021 at 06:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within 2 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 07Mar2021 at 18:00 the patient had experienced headache, earache, glands swollen and on 14Mar2021, she had pinky toe, stabbing pain in eye, stye forming which followed by ulceration under eyelid. It was reported that all events occurred on left side of body and lasted for 2 days moving from a different area each time. Adverse events resulted in the doctor or other healthcare professional office/clinic visit. The patient was treated with gentamicin for the reported events. The patient underwent COVID-19 virus test post vaccination, which included SARS-CoV-2 RT PCR (Nasal swab) test on 15Mar2021 and the result was found to be negative. The clinical outcome of the events headache, earache, swollen gland in neck, pinky toe, stabbing pain in eye, stye forming and ulceration under eyelid was resolved in Mar2021. No follow-up attempts are needed. No further information is expected.
58 2021-07-08 peripheral swelling, lymph node swelling slight itching and small bump onright arm.; small bump on right arm; discomfort with small knot in l... Read more
slight itching and small bump onright arm.; small bump on right arm; discomfort with small knot in lower right abdomen; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA vaccine; Lot number; En6208) via an unspecified route of administration in the right arm on 20Mar2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and type 2 diabetes. The patient had a history of allergy to shellfish and PAC (perennial allergic conjunctivitis). Concomitant medications received within two weeks of vaccination included valsartan (MANUFACTURER UNKNOWN) and metformin hydrochloride (MANUFACTURER UNKNOWN) for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 24Mar2021 at 16:00, the patient had experienced slight itching and small bump on right arm. She had noticed discomfort with a small knot in lower right abdomen on Wednesday. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events slight itching and small bump on right arm, discomfort with small knot in lower right abdomen were not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
58 2021-07-08 peripheral swelling but did want to take a look at the rash; stabbing feeling in her left wrist; left arm injection site... Read more
but did want to take a look at the rash; stabbing feeling in her left wrist; left arm injection site pain/ Left arm pain near injection site going towards her back; tingling on the left arm; rash on the injection site/Rash on arm near injection site that feels like a bump and is itchy; itchiness; right middle and index finger swelling; arm swelling; something was at the back of her throat; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN5318 at the age of 58-year-old), dose 1 intramuscular, administered in arm left on 08Feb2021 as single for covid-19 immunization in clinic at a fitness centre. Not a military facility. Time the vaccination was given to the patient between 11:45-11:50. Medical history included allergic to bees, penicillin and benadryl (when she got stung by a bee) and thyroid. Lot number, expiration date and manufacture were unknown for penicillin and benadryl as it was couple of years before. When she had stung by a bee (she had EpiPen with her she had not used it she kept ready in case). The Concomitant medications included levothyroxine sodium (SYNTHROID) taken 75 ug, once a day for thyroid (took for 2 years). The patient previously took benadryl and experienced drug hypersensitivity. The patient did not receive any other additional vaccines administered on same date of the suspect drug. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 08Feb2021 18:00, the patient experienced tingling on the left arm where she got injection, rash on the injection site/Rash on arm near injection site that feels like a bump and is itchy , itchiness, right middle and index finger swelling, arm swelling and something was at the back of her throat. On 09Feb2021 12:00, the patient experienced left arm injection site pain/ Left arm pain near injection site going towards her back. On 09Feb2021 15:00, the patient experienced stabbing feeling in her left wrist. On an unknown date, the patient sated that but did want to take a look at the rash. Clinical course the patient had the first one on (08Feb2021) Monday and was fine and did not feel anything until 6 hours later. On 08Feb2021 18:00, she then had tingling on left arm where she got shot. The patient felt like needles like her hand was falling asleep. Her hand felt kind of big and she looked at her hand and saw that her fingers were swollen. The tingling started 6 hours after receiving the vaccine. It had lessened and comes and goes. Her doctor just said to keep moving her arm. The site was also red and when she passed her hands over it, it feels like a bump and was itchy. The injection was on left arm, but for some reason, she felt the same on right arm. That went away and only lasted a couple of hours. She did not get tingly feeling on right hand, but right hand did had finger swelling that was just on the middle and index finger. When you try to make a first you feel a tightness and that was just on the left side. It had improved when she took Ibuprofen. She took it to help the swelling to go down on shoulder and helped with tingling and swelling of fingers. She could breathe and swallow but did not know if something was swollen. She had not taken motrin this morning yet. When she takes it, everything looks fine for a while. The swelling goes down and she feels better. The patient reported that her left arm near injection site, she is beginning to feel pain going towards back of her arm. The stabbing feeling in her wrist comes and goes. She was not sure if she should take second dose and was scared to get it. The patient received treatment for the events tingling on the left arm and right middle and index finger swelling with Ibuprofen. No emergency room or physician's office was required to the patient. The outcome of the events tingling on the left arm and rash unknow. The outcome of the events rash on the injection site, itchiness, arm swelling, something was at the back of her throat, left arm injection site pain and stabbing feeling in her left wrist was not resolved.The outcome of the event right middle and index finger swelling was resolving. Follow-up attempts completed. No further information expected.
58 2021-07-10 peripheral swelling blood clot right leg in groin area; cyst in left leg behind the knee; Both of her legs started swell... Read more
blood clot right leg in groin area; cyst in left leg behind the knee; Both of her legs started swelling up; muscle spasms in her leg; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0182) via unspecified route of administration in in left upper arm on 09Jun2021 at 11:00am, at patient age of 58-year-old, as a single dose for COVID-19 immunisation. The patient medical history included Covid-19 in Oct2020. The patient concomitant medications was none. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number RA7886) via unspecified route of administration on 19May2021 at 11:00am, at patient age of 58-year-old as a single dose for COVID-19 immunisation and experienced diarrhea. In Jun2021, the patient experienced blood clot right leg in groin area, cyst in left leg behind the knee. This is affecting her health and she has a lot of bills racking up. She had not had any blood clots or anything like this till after the shots. Blood clot and Cyst occurred around the same time. Both of her legs started swelling up. She went to the doctor on 14Jun2021 since both legs were swollen and it would not go away. They did an ultrasound of the vein, a test called HCUS vein extremity was done. She had another test called a DUP scan and one called XTR vein complete. When querying results, she reported that one of the tests found the main clot and then went into check that there was nothing missed. She did not know exactly when the blood clot and cyst started but 14Jun2021 is when it started to take a toll on her body. She knew it did not feel right but did not know why. She was fine before that. Regarding cyst outcome, she can see and feel it more. Sometimes it gets to where if someone were to put their hands around her leg and squeeze real tight with pressure, it is very odd. As treatment, she was on an acetylsalicylic acid (BABY ASPIRIN). She has an appointment made to see a specialist for medical oncology and hematology. Since the second shot she had muscle spasms in her leg so bad that even when she stood up, she could not get it to stop, it was so painful and never had anything like that before. The events did not require a visit to emergency room, but required a visit to physician office. The outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.
58 2021-07-10 swelling face Patient received her shot in the afternoon and called us 3 or 4 hours later to report she was experi... Read more
Patient received her shot in the afternoon and called us 3 or 4 hours later to report she was experiencing swelling in her cheeks. She did not have any shortness of breath or swelling. She took a benadryl on 7-9-21 and again on 7-10-21 and on 7-11-21 she stated her swelling has gone down significantly.
58 2021-07-11 c-reactive protein increased Started with joint inflammation and pain in right knee and progressed over weeks with overall muscle... Read more
Started with joint inflammation and pain in right knee and progressed over weeks with overall muscle tightness, stiffness and pain. Joints affected are knees, big toes and small bone at base of right thumb. Right knee is the most severe with pain, stiffness and muscle tightness and weakness - making prolonged walking or going upstairs / getting down or up from the floor difficult. Other odd symptoms are random pains throughout muscles/ joints the "move" from place to place and tingling or zapping pains in bones of feet and legs. Toes turn blue/purple. I was fine before the injections and was doing an at home walking program. Can no longer do this without pain and have limited endurance. To me this appears to be an autoimmune reaction.
58 2021-07-12 lymph node swelling, lymph node pain stomach cramps; dizziness; axillary lymph node enlargement and pain; Fever 102; body aches; severe c... Read more
stomach cramps; dizziness; axillary lymph node enlargement and pain; Fever 102; body aches; severe chills; joint pain; headache; nausea; axillary lymph node enlargement; local site reaction/pain; local site reaction/pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an intramuscular route of administration in the left arm on 25Mar2021 at 09:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and hypothyroidism. Concomitant medications included HCTZ (hydrochlorothiazide) (MANUFACTURER UNKNOWN), Withania somnifera (ASHWAGANDHA), levothyroxine (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an intramuscular route of administration in the left arm on 04Mar2021 at 09:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient previously received morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Mar2021 at 19:00, the patient experienced fever 102, severe chills, body aches, joint pain, headache, nausea, stomach cramps, dizziness, local site reaction/pain, and axillary lymph node enlargement and pain. The symptoms began 10 hours post injection and lasted 48 hours. The patient did not receive any treatment for events fever, chills, general body pain, joint pain, headache, nausea, stomach cramps, dizziness, axillary lymph nodes enlarged, vaccination site pain, vaccination site reaction and lymph node pain. The clinical outcomes of the events fever, chills, general body pain, joint pain, headache, nausea, stomach cramps, dizziness, axillary lymph nodes enlarged, vaccination site pain, vaccination site reaction and lymph node pain were recovered on 27Mar2021 at 19:00. No follow-up attempts are needed. No further information is expected.
58 2021-07-12 lymph node swelling Swollen lymph node in left neck base, left and right armpit; discomfort and second day is the same w... Read more
Swollen lymph node in left neck base, left and right armpit; discomfort and second day is the same with arm pit discomfort; This is a spontaneous report received from a contactable consumer, the patient. A 58- years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7533) via an unspecified route of administration administrated in the left arm on 25Mar2021 at 13:00(at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to sulpha drugs. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date and for an unknown indication received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via an unspecified route of administration administrated in the left arm on 04Mar2021 at 13:00 as a single dose for COVID-19 immunisation. The patient was also allergic to epinephrine and codeine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 26Mar2021 at 16:00 the day after the vaccine the patient experienced lymph nodes in left neck base swelled and were very uncomfortable. Then lymph nodes in left armpit swelled and caused discomfort, second day was the same with right armpit discomfort. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests which included nasal swab on 20Mar2021 and tested negative post vaccination. The clinical outcome of the event swollen lymph node and discomfort was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
58 2021-07-12 swelling face On 05/12/2021, my eyelid, on my right eye, started swelling and it started swelling down into my ch... Read more
On 05/12/2021, my eyelid, on my right eye, started swelling and it started swelling down into my cheek. I saw Dr. 05/14/2021. The doctor diagnosed me with an infection in the eyelid and she prescribed the antibiotic, Tobramycin. The swelling lasted for like 5 days.
58 2021-07-16 lymph node swelling Patient received vaccine and was observed for 15 minutes. She received Pfixer EW0185 at 8:32 She lef... Read more
Patient received vaccine and was observed for 15 minutes. She received Pfixer EW0185 at 8:32 She left the covid center and was in car and stated that she felt a little SOB and that her left gland felt swollen. This was 8:55. Took her back to the observation center 9:05 Allegra 9:15 Vitals 180/102 HR 99 Pulse ox 100% resp 20 Gave Allegra at 9am- vis- 150/94 HR 85 Pulse ox 100% Resp 20 Feeling a little better She did let me know that she met with her private allergist this past Thursday 7/15/21 and he told her she could have vaccine. They also did more testing to foods, environment and medication- results are not all in as of yet 9:30 153/93 HR 75 98% Resp 18 States feeling better - gland not as swollen 9:50- 155/91 states her blood pressure meds were stopped about 6 months ago and she has noticed that it has been going up. Told her to consult her PCP She is feeling better. Instructed to take Allegra at home that her allergist prescribed if needed. Go to ER if she gets SOB or other symptoms get worst. She will also notify her allergist. Was taken to bathroom by nurse and left with her husband. Feeling much better.
58 2021-07-17 peripheral swelling, lymph node swelling, swelling face throat closure; her face very puffy/she had a lot of swelling to where she doesn't look like herself... Read more
throat closure; her face very puffy/she had a lot of swelling to where she doesn't look like herself anymore; swelling on lymph nodes around arms; brain fog; her right arm where she got her injection had more swelling than anything on her left side; This is a spontaneous report from a contactable consumer (patient). A Female patient of 58-years age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose on right arm via an unspecified route of administration on 29Mar2021 (Batch/Lot number was ER 2613), (Expiration date- 31Jul2021)at dose 1, single for COVID-19 immunisation. Medical history include Hypertension, Hypothyroidism, Prediabetes, Asthma. No concomitant medications reported. She says she had her first dose of the shingles vaccine over 6 months ago, that was a long time ago, which she had that early, that's about it. She says the last vaccine before this one was the flu vaccine, in September 2019. she has COVID brain that she had when she had the shot, it felt like she was drugged for two days, the fog that comes with COVID when you get COVID, like that. Caller clarifies that she has not had COVID. she called to report side effects and to hopefully get information about whether or not to get second dose. She says she wanted to report adverse side effect to the COVID-19 vaccine, she got the first dose on 29Mar and she had throat closure. She says she got assistance by paramedics, and she took her Albuterol, which helped. She says two days later, her face very puffy, she had a lot of swelling to where she doesn't look like herself anymore. She says she also had swelling on lymph nodes around arms. She says for her throat closure she did not go to the hospital, they put her in a wheelchair and wheeled her to a private cooler location with a lot of air conditioning and she was fine, they checked her out and she was ok, her Albuterol worked for her throat. Albuterol inhaler: 66993-019-68, LOT/EXP She says this information is covered by part of her inhaler and she doesn't have the box the cartridge came in, and doesn't want to remove it. She says her swelling is a bit better, her face is just a little swollen, her face and neck and all. She says her lymph node swelling is a little down, her right arm where she got her injection had more swelling than anything on her left side, and it is a little bit better. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.
58 2021-07-17 peripheral swelling Itchy rash; Hives over body; Fingers swelled; Eyelids swelled; lips swelled; Lump in throat; This is... Read more
Itchy rash; Hives over body; Fingers swelled; Eyelids swelled; lips swelled; Lump in throat; This is spontaneous report from contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 2613) via an unspecified route of administration in the left arm on 17Mar2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included lymphoma in 2012-13. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), Cholecalciferol (VITAMIN D3), Calcium pantothenate; Nicotinamide; Pyridoxine hydrochloride; riboflavin; Thiamine hydrochloride (B COMPLEX) and Esomeprazole magnesium (NEXIUM). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Since the vaccination, the patient was not tested for COVID-19. On 18Mar2021 at 07:30, the patient experienced, itchy rash, hives over body, fingers, eyelids and lips swelled and felt like a lump in her throat. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient took Benadryl as therapeutic treatment for the reported events. The clinical outcome of the event itchy rash, hives over body, fingers, eyelids and lips swelled and lump felt in her throat resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
58 2021-07-17 peripheral swelling I got my first vaccine,I had pain on side of my head, one side; swelling on arm, it was paining me f... Read more
I got my first vaccine,I had pain on side of my head, one side; swelling on arm, it was paining me for days; This is a spontaneous report from a contactable consumer or other non hcp. A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0186) via an unspecified route of administration, administered in arm left on 26May2021 as single dose for COVID-19 immunization. Medical history included thyroidectomy from 2016 to an unknown date. Concomitant medications were not reported. The patient stated I I had a thyroid surgery I am not on medication. It's no medical history I have I only had a surgery in throat I had in 2016 and my thyroid hormones are no more I am not on medication. The patient stated i got my first vaccine, i had pain on side of my head, one side, swelling on arm, it was paining me for days and after 2 weeks she did not feel any pain on May2021. Therapeutic measures were taken with Tylenol, strength 800mg, took two tablets as a result of event I got my first vaccine, I had pain on side of my head, one side. The patient underwent lab tests and procedures which included blood test: unknown (I am not diabetic). The outcome of events was recovered.
58 2021-07-18 peripheral swelling after the 2nd dose, 2 days later the patient felt she has arthritis, legs and hands were swollen, nu... Read more
after the 2nd dose, 2 days later the patient felt she has arthritis, legs and hands were swollen, nuckles are swollen and painful and the patient can barely walk. she hiked 4 miles a day and now she cannot even go room to room
58 2021-07-19 lymph node swelling very large moveable lymph node on left clavicle; whole arm is sore; breast tissue is sore; whole arm... Read more
very large moveable lymph node on left clavicle; whole arm is sore; breast tissue is sore; whole arm and into her breast tissue is sore and into my neck; This is a spontaneous report from a contactable other healthcare professional, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 25Mar2021 at 10:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism, hypertension, cholesterol high, fibromyalgia. The patient had allergy with mold me flex. Concomitant medications received within 2 weeks of vaccination was reported as 'my prescribed meds'. The patient previously received cefaclor (CECLOR) and clarithromycin (BIAXIN), both for an unknown indication and experienced drug allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 16:00, the patient experienced very large moveable lymph node on her left clavicle, whole arm and into her breast tissue were sore and into neck. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the event very large moveable lymph node on left clavicle, whole arm and into her breast tissue is sore and into neck were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
58 2021-07-21 peripheral swelling, fluid retention, swelling face After 1 got the 1 st dose vaccine, a few hours later around 1pm, I was having blurred vision. I f... Read more
After 1 got the 1 st dose vaccine, a few hours later around 1pm, I was having blurred vision. I felt very tired, nausea and exhausted and I went home and went to bed. I did take some Tylenol to help relieve my symptoms. I also had left leg swelling, my face was puffy and I was just not feeling good. I had problems focusing, brain fog, complete fatigued, absolutely no energy and completely worn out. I have issues with blood circulation on the left side of my body and I had fluid rentention on my torso and my face. The swelling lasted for 10 days. I still have some swelling but not as bad as before. I do wear compression socks to help alleviate the swelling accumlation. I also have right side numbness on my face, foot and back. I also have difficulty talking and expressing words and getting words out. This lasted for 2 weeks. I still have this deficit and it comes and goes. It is not as bad as before. I have neck and back pain and my headaches are very bad. The pain can be measured 8/10. I did go to the ER and did run a bunch of test, labs, MRI- which came back normal. I followed up with my PCP and will be following up with neurology and pain clinic.
58 2021-07-24 fluid retention, peripheral swelling Sharp pain to *temple of head,* Irradic heart BP & *Pulse * Severe Swelling of Limbs Extra On the Le... Read more
Sharp pain to *temple of head,* Irradic heart BP & *Pulse * Severe Swelling of Limbs Extra On the Left Side Arms got rash that was bumpy and would burn *Also Sternum to Waiste Water retention took weight 185 To 207 over night *** Still occurring Sweeting profusely, Temperature {My norm is 87.8} Heavy breath wheezing Mucus white crystallized/hard Nebulizer air pro inhailet high 101.8 & very low 94° Dehydration Diarrhea stomach cramps chills
58 2021-07-26 fluid retention Nausea, headache, body inflammation & significant fluid retention, joint aches & pains, muscle pain... Read more
Nausea, headache, body inflammation & significant fluid retention, joint aches & pains, muscle pain, weight gain
58 2021-07-27 lymph node swelling, lymph node pain Lymph node pain; Loss of bladder control; Neckache; Fever; Chills; Headache; Lymph node swelling; Bo... Read more
Lymph node pain; Loss of bladder control; Neckache; Fever; Chills; Headache; Lymph node swelling; Body aches; Shortness of breath on exertion; Extreme fatigue- slept 35hrs; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm left on 24Apr2021 at 15:15 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism and Meniere's disease. Concomitant medications include DEVA multivitamin and mineral supplements. Past drug history includes codeine. The patient previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm left on 03Apr2021 at 10:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 at 22:30 the patient experienced fever for 24 hours, chills, headache; neckache, lymph nodes swelling/pain, body aches, loss of bladder control, shortness of breath on exertion and extreme fatigue(slept 35 hrs). The clinical outcome of the event fever for 24 hours, chills, headache; neckache, lymph nodes swelling/pain, body aches, loss of bladder control, shortness of breath on exertion and extreme fatigue were resolved with sequelae. No follow-up attempts are needed. No further information is expected.
58 2021-07-27 lymph node swelling Headache; Night sweats; Swollen lymph node in armpit; Mild all over body itching; This is a spontane... Read more
Headache; Night sweats; Swollen lymph node in armpit; Mild all over body itching; This is a spontaneous report from a contactable consumer, the patient. A 58-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm left on 11Mar2021 at 14:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN SR), calcium (MANUFACTURER UNKNOWN), vitamin b 12 (MANUFACTURER UNKNOWN) and vit D (MANUFACTURER UNKNOWN) all for unknown indication, from unknown date within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. In Mar2021, the patient experienced headache, night sweats, swollen lymph node, armpit and mild all over body itching. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, night sweats, swollen lymph node, armpit and itching all over body were recovered. No follow-up attempts are needed. No further information is expected.
58 2021-07-27 peripheral swelling Arm was swollen; Arm can't move; This is a spontaneous report from a contactable consumer or other n... Read more
Arm was swollen; Arm can't move; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 58-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in Arm Right on 19May2021 (age at vaccination: 58-years-old) as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. The patient got the vaccine on Wednesday, 19May2021, then after she got that shot she came home, her arm was swollen she could go to work since Wednesday and Thursday her arm could not move, so she called off at work. Patient did not receive any treatment for the events. The outcome for the events was unknown. Follow-up attempts are needed. Further information is expected.
58 2021-07-27 swelling Chills; Fever; Extreme tiredness; Nausea; Swelling; Extreme tenderness; Slight pain under left armpi... Read more
Chills; Fever; Extreme tiredness; Nausea; Swelling; Extreme tenderness; Slight pain under left armpit; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 30Mar2021 at 15:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to aluminium when used as a preservative for an injection. Concomitant medications included vit B12 (MANUFACTURER UKNOWN), vit D (MANUFACTURER UKNOWN) and fiber. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 10Mar2021 at 15:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, approximately 18 hours after second vaccine the patient experienced chills, fever, extreme tiredness and nausea. On 31Mar2021, approximately 24 hours after second vaccine the patient experienced swelling, extreme tenderness and slight pain under left armpit. After about two days, the patient did not experience symptoms any longer. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events chills, fever, extreme tiredness, nausea, swelling, extreme tenderness and slight pain under left armpit was resolved on 02Apr2021. No follow-up attempts are needed. No further information is expected.
58 2021-07-28 sepsis Patient presented to the ED and was subsequently hospitalized for pneumonia of right lung, Sepsis wi... Read more
Patient presented to the ED and was subsequently hospitalized for pneumonia of right lung, Sepsis with acute hypoxic respiratory failure without septic shock within 6 weeks of receiving COVID vaccination.
58 2021-07-29 peripheral swelling body hurting/body hurts/body aches; can hardly walk; weakness; swollen arm/; Swollen arm where the i... Read more
body hurting/body hurts/body aches; can hardly walk; weakness; swollen arm/; Swollen arm where the injection was given; This is a spontaneous report from a contactable consumer (patient herself). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FA7485), via an unspecified route of administration, administered in left arm on 13Jul2021 (age at vaccination: 58 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included covid-19, ongoing diabetes mellitus, sinusitis, thyroiditis and pain. Concomitant medication(s) included topiramate (has been on for a couple of years) taken for headache; gabapentin (has been on for a few years); levothyroxine sodium (THYROXINE) (has been on for a couple of years) taken for thyroiditis; estradiol; montelukast sodium (SINGULAIR) 10mg taken for sinusitis; pravastatin; metformin 500mg taken for diabetes mellitus and hydrocodone taken for pain in her back and down her legs. On 13Jul2021, the patient's body was hurting/body hurts/body aches, can hardly walk, weakness, swollen arm where the injection was given which started yesterday evening and has gone down some since she soaked it. The patient stated that body pain started last night, or actually yesterday when she was at work; weakness started yesterday evening, it was about the same and has not gotten better. There was no treatment was given for the adverse events. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency room and physician's office. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on an unknown date. The outcome of the event pain, gait disturbance, asthenia, was not recovered; peripheral swelling, vaccination site pain was recovering. There was no product quality complaint (PQC) present.
59 2021-01-02 lymph node swelling Large soft as well as hard swollen lymph glands and nodes in neck and clavicular region and severe ... Read more
Large soft as well as hard swollen lymph glands and nodes in neck and clavicular region and severe muscle aches and pains in upper body and neck.
59 2021-01-04 anaphylactic reaction Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea ... Read more
Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea and numbness and tingling in fingertips 5 minutes after administration of vaccine and proceeded to bathroom. Patient with unwitnessed vomiting prior to RN assessment. RN assessed patient and taken safely to private evaluation room. AED pads applied per protocol. Epi-Pen administered. EMS called. Vital signs stable. Patient complained of itching and erythema in left arm around injection site. MD evaluated patient and advised to be further assessed in ER. Patient continuously evaluated by RN and EMS. Patient transported to ER in stable condition.
59 2021-01-04 anaphylactic reaction after the vaccine on the 19th I woke up with a bad headache and sore throat, not intense I just fel... Read more
after the vaccine on the 19th I woke up with a bad headache and sore throat, not intense I just felt like I was getting sick I took Motrin, Over the weekend I had significant heart beating which was very out of the ordinary I saw my physician. It felt anaphylactic. Dr did not prescribe anything I was asked to watch my symptoms
59 2021-01-04 swelling pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit ... Read more
pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; It goes up and down, feels sort of like catching the flu; This is a spontaneous report from a contactable Pharmacist reporting for herself. A 59-years-old female patient received bnt162b2 (BNT162B2) vaccine , intramuscular in the left upper arm on 23Dec2020 10:30 at single dose for Covid-19 immunisation . Medical history included ongoing hypertension , Covid-19 from 25Mar2020 to an unknown date treated with azithromycin. In Jun2020 she had antibodies against COVID-19. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE). The patient experienced pain/soreness at the injection site, swelling, chills, muscle and body aches, headache and feels sort of like catching the flu on 23Dec2020 with outcome of not recovered. The soreness started about 4 hours after the injection and during that night it progressed with the chills and body/muscle aches. Did take Tylenol to help and took it throughout the night and the day after and drinking fluids. Stated if condition goes on much longer or worse then she will have to go to the hospital. Lot/Batch and Expiration date has been requested.
59 2021-01-05 lymph node swelling On day after vaccine had chills and fever(99.7) for ~ 24 hours. Also had muscle and joint pain, very... Read more
On day after vaccine had chills and fever(99.7) for ~ 24 hours. Also had muscle and joint pain, very sore arm at injection site, mildly swollen lymph nodes. All noted on handout to be possible side effects. ***Day 2 after vaccine has very red rash all over neck, chest, abdominal and back areas with some itching that lasted ~ 72 hours but was less visible each day after initially noted. No medical treatment sought as resolved on its on
59 2021-01-05 swollen extremities 6:15 pm Chilling, cold to touch, afebrile. 10 pm woke up still chilling afebrile. Swelling in righ... Read more
6:15 pm Chilling, cold to touch, afebrile. 10 pm woke up still chilling afebrile. Swelling in right axilla. Tightness around upper arm/axilla area. No redness at injection site. 5 am weakness in lower legs, shakey/jittery, and dizziness. Bp 129/75, HR 65, resp 16, O2 say 96. 9 am dizziness subsided 11 am weakness in legs subsided, axilla swelling subsided, soreness remains.
59 2021-01-05 peripheral swelling, lymph node swelling Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of... Read more
Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; This is a spontaneous report from a contactable Other Health Professional (patient). This 59-year-old female Other Health Professional (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ej1685) on 21Dec2020 11:00 AM at single dose in Left arm for covid-19 immunization. Medical history was hypertension, hypothyroidism. Concomitant drug included levothyroxine/liothyronine (NP THYROID), HCTZ, Amlodipine. No other vaccine in four weeks. Started with aches in the back NA increased temp swollen lump nodes under the arms and neck bottoms of the feet swollen from 27Dec2020 with outcome was recovered. No treatment. No covid prior vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19: negative on 28Dec2020. No follow up attempts are needed. No further information is expected.
59 2021-01-05 peripheral swelling, swollen extremities 1/5/20: 6:15 pm Became tired, chilling, afebrile, cold touch, soreness at injection site. 9:00 ... Read more
1/5/20: 6:15 pm Became tired, chilling, afebrile, cold touch, soreness at injection site. 9:00 pm dizziness, tightness around right upper arm, swelling in right axilla. afebrile. 1/6/20: 5:00 am; chilling subsided. dizziness, weakness and jittery feeling in both legs, soreness at injection site, no redness, swelling in axilla slightly improved. Heart rate 72, respirations 16, 02 sat 96%. bp 129/75. 9:00 am: dizziness, right axilla swelling gone. Soreness in right axilla, weakness in lower extremeties improving. 11:00 am : weakness and jiters subsided, right axilla remains sore.
59 2021-01-06 swelling, swelling face Angioedema swelling and redness of face; eyes swollen Narrative: Employee was seen in the clinic the... Read more
Angioedema swelling and redness of face; eyes swollen Narrative: Employee was seen in the clinic the following day and symptoms had resolved.
59 2021-01-06 lymph node inflammation Vaccination 1/5 @ 10:30 am - mild left arm discomfort @ injection site, otherwise no symptoms On 1/... Read more
Vaccination 1/5 @ 10:30 am - mild left arm discomfort @ injection site, otherwise no symptoms On 1/6 eve, approximately 10 pm, noted worsening to severe pain in left anterior shoulder/ subclavicular area into axilla with prominent & well delineated area of swelling & tenderness, most prominent in & just below axilla, associated with numbness & tingling down the ulnar side of arm to 2 fingers (ring & little finger).
59 2021-01-06 lymph node swelling stomach cramps, nausea, dizziness, subjective fevers, bilateral swelling cervical nodes, denies sore... Read more
stomach cramps, nausea, dizziness, subjective fevers, bilateral swelling cervical nodes, denies sore throat, mild headache, denies respiratory difficulties. States that with 1st vaccine had hives inside rt elbow and wrist,
59 2021-01-06 swelling face Patient's states that she woke up at 3 am on 1/7/2021 with left sided facial swelling and lip swelli... Read more
Patient's states that she woke up at 3 am on 1/7/2021 with left sided facial swelling and lip swelling and she went back to sleep and woke up again around 5:30 am and swelling had gone down, and then at 10:30 am patient reports that left facial swelling and left lip swelling completely resolved. Pt. denies taking anything to resolve swelling of left face and lip.
59 2021-01-07 lymph node swelling 1-7 middle of the night was achy and had headache. Thursday headache became more severe and had body... Read more
1-7 middle of the night was achy and had headache. Thursday headache became more severe and had body aches. Thursday night had a low grade temp and the headache got severe and she developed lymph node swelling in R axilla. She continues with headache that is bad and body aches but no fever today 1-8-2021
59 2021-01-07 oral herpes Oral Herpes outbreak, severe
59 2021-01-08 lymph node swelling left side lymph node swelling x3 days, began on 1/3/21, also has fatigue, has been afebrile, no othe... Read more
left side lymph node swelling x3 days, began on 1/3/21, also has fatigue, has been afebrile, no other issues Narrative: Has not required medical attention yet. Today now feels there may be some ear pressure. Advised to f/u with PCP if ear begins to bother her more and update Occ. Health. No known exposures to anyone who has tested positive for COVID-19 infection.
59 2021-01-09 swelling I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 210... Read more
I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 2100 on 1/8, began to develop a lot of pain at the injection site. Within 2 hrs of that time, I developed other symptoms, which include total body (bone and joint) pain (especially in my knees), and what I would describe as a "bad sunburn type" rash across my cheek bones, bridge of my nose, and orbital area. Small raised bumps to this area, with swelling, and a feeling of pins and needles stabbing me all across my face. My airway was fine, and at no time did I feel shortness of breath. I was unable to sleep due to the bone and joint pain, and felt the need to walk continually (it was more painful to stay in one position). These symptoms persisted throughout the day (Saturday 1/9/21), noting at 5pm I described myself "miserable" to my friends and family. All symptoms described above, were at their most elevated intensity between the hours of 1700 - 0400. At 0400 Sunday (1/10/21) I felt a gradual release of the body aches, enough so that I could sleep until 0800. At this time, 1300 (Sunday 1/10) I note that I still feel "flu type" body aches, but constant pain has diminished in intensity by estimated 50%. The sunburn type redness and swelling across my face/orbital area has also less by 50% (there is still redness, mild swelling, warmth, and some raised bumps across this area; pins and needles feeling is gone).
59 2021-01-10 lymph node pain, lymph node swelling soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 o... Read more
soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 of 101.3; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; had joint pains/knees and hip joint pain; severe fatigue; muscle pain; This is spontaneous report from a contactable nurse (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in right arm on 30Dec2020 14:15 at first single dose (0.3 cc, but really uncertain of dose) for covid-19 immunization. Medical history included COVID virus from Nov2020 to 2020 (The patient was not hospitalized. It was a mild case and lasted about 10 days. she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue). The patient's concomitant medications were not reported. The patient did not receive any other vaccines at the same time or 4 weeks prior. No problems with vaccinations in past or events. Caller reported she had the first injection of the Pfizer BioNTech COVID-19 vaccine on the 30Dec2020 and having some side effect symptoms and her supervisor recommended for her to report these things, they are not life threatening, obviously, but things were still lingering. Side effect of severe fatigue started on the 31Dec2020 and lasted for 72 hours. It was so severe, now it is mild. The patient reported soreness around the injection site. Had a fever on the night of the 31Dec2020 of 101.3 and had that for 6 hours then it dissipated and was gone. Had never had a fever after injections before. Had severe arm pain that usually goes along with an injection. It started also that night of 31Dec2020. She had rolled over in the middle of the night and it hurt. That lasted for about 48 hours, but it has improved. Had some muscle aches since 31Dec2020 but that had improved and had joint pains since 31Dec2020. What was worrisome was the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes, since 31Dec2020. The patient was still having that and that is why she was so concerned because shouldn't that have gone away after a week. Had knee and hip joint pain, but that had improved. Again, mentioned she had never had that before with an injection. The patient received vaccine at her workplace. Some of her coworkers got it the same day and no one else has this. Mentioned she did have COVID virus back in Nov2020 and wonders if this correlates with her getting the vaccine. Was not hospitalized or notified she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue. This is the same way she felt back when she had the virus back in November. The patient was concerned about having these side effects would it be okay for her to get the next injection in 3 weeks. AEs did not require a visit to emergency room and physician office. No further details provided. Outcome of the events Fever was recovered, of event swollen and painful lymph nodes was not recovered, of events knees and hip joint pain, fatigue, muscle pain, severe arm pain was recovering, of event soreness around the injection site was unknown. The reporter considered the events severe fatigue, fever, swollen lymph nodes and pain under right arm, knees and hip joint pain as serious (medically significant). The reporter considered the events severe fatigue, fever, severe arm pain, muscle ache, swollen lymph nodes and pain under right arm, knees and hip joint pain as related to BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
59 2021-01-10 swelling sore throat, headache, swelling and very, very sore feeling in the left arm, tingling in the tips o... Read more
sore throat, headache, swelling and very, very sore feeling in the left arm, tingling in the tips of fingers (feeling pricked in the fingertips).
59 2021-01-11 lymph node swelling swollen axillary lymph nodes on the same side vaccine was given. Prescribed Ibuprofen 600 mg tablet... Read more
swollen axillary lymph nodes on the same side vaccine was given. Prescribed Ibuprofen 600 mg tablet by primary physician
59 2021-01-11 swollen extremities, c-reactive protein increased After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I dev... Read more
After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I developed a goose egg size swelling under my left armpit, numbness, tingling in my hands, and feet that proceeded with coldness and parlor of my hands, this has occurred daily along with headaches, reddish blotchy patches on my skin. My symptoms progressed on 7 Jan to needle prick sensations all over my body, to include the numbness and tingling, cold hands and feet. On 8 Jan I went to see my doctor and explained my symptoms, labs were drawn. 12 Jan i was placed on Medrol Dose pack, symptoms stills present.
59 2021-01-12 lymph node pain, lymph node swelling Rash and swollen lymph node on my left side of my neck very painful to touch .Day before I had a ... Read more
Rash and swollen lymph node on my left side of my neck very painful to touch .Day before I had a check up with my doctor with no symptoms.. Injection on left high upper arm redness around . Muscles pain and tremors of my hands , tired Diarrhea for two days and sweats.
59 2021-01-13 lymph node swelling Multiple, large, hard and soft swollen lymph nodes in neck and above and below clavicle in same arm ... Read more
Multiple, large, hard and soft swollen lymph nodes in neck and above and below clavicle in same arm as vaccine given; severe aches and pains in neck and upper back; severe aches and pains in neck and upper back; This is a spontaneous report from a contactable nurse (patient). A 59-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EH9899; expiration date: unknown), via an unspecified route of administration right arm on 21Dec2020 12:00 PM at a single dose for covid-19 vaccination. Medical history included latex allergy. The patient's concomitant medications were not reported. The patient previously took telithromycin (KETEKS) and clonidine, but both had allergies. The patient received the most recent COVID-19 vaccine administered in a hospital. The patient reported that she had multiple large, hard and soft swollen lymph nodes in neck and above and below clavicle in same arm as vaccine given, severe aches and pains in neck and upper back on 27Dec2020. The patient did not received treatment for the adverse event. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering.
59 2021-01-13 swelling face The patient developed swelling of left jawline and L side of lips that began 12-14 hours after injec... Read more
The patient developed swelling of left jawline and L side of lips that began 12-14 hours after injection. She denies any other symptoms. Denies itching or pain of area. Denies swelling of tongue or throat. Denies shortness of breath. Was seen by her PCP and symptoms were attributed to angioedema due to ACEi medication.
59 2021-01-14 anaphylactic reaction At 09:30 am patient complaints of H/A, nausea, SOB and cough. Vitals signs BP 159/103 mmHg, HR 79 bp... Read more
At 09:30 am patient complaints of H/A, nausea, SOB and cough. Vitals signs BP 159/103 mmHg, HR 79 bpm and O2sat 100%. A rapid response code for an anaphylactic reaction was activated at 9:35am. Patient was transferred to the ER vital signs were BP 173/123mmHg , HR 106 bpm, Dxt 93 and O2sat 94%. One dose of Epinephrine 0.3mg IM, D5W 20g/250ml IV, Benadryl 50mg IV and Solu-Cortef 200mg IV were administrated.
59 2021-01-14 swelling face Resident had facial swelling this morning along with uncontrolled muscle movements and tremors. Resi... Read more
Resident had facial swelling this morning along with uncontrolled muscle movements and tremors. Residents blood pressure was elevated as well and she complained of nausea. Resident was fine this morning and the past several days with no complaints. This resident has a history of muscle spasms and tremors as well as some catatonic states in the past.
59 2021-01-15 anaphylactic shock anaphalactic shock reaction, epi injection by hospital emergency staff at vaccine site, emergency r... Read more
anaphalactic shock reaction, epi injection by hospital emergency staff at vaccine site, emergency room admission . We were very lucky vaccine site was Hospital was concerned that this might happen as patient had a previous anaphalactic shock by antibiotic injection few years ago
59 2021-01-18 lymph node swelling I received my shot in upper left arm 1/15/21 @ 1:45pm and on Sunday 1/17/2021 in am I'm noticing pai... Read more
I received my shot in upper left arm 1/15/21 @ 1:45pm and on Sunday 1/17/2021 in am I'm noticing pain on the left side of my breast and armpit area. I felt my lymph nodes and they are swollen as well. I stopped wearing a bra because it was painful.
59 2021-01-18 lymph node swelling Pt developed injection site tenderness and bruising three days after vaccine. Pt has been self admin... Read more
Pt developed injection site tenderness and bruising three days after vaccine. Pt has been self administrating Benadryl at home. Pt also has bilateral lymphadenopathy in her armpits.
59 2021-01-19 lymph node pain 48 hours after second vaccine I woke up with pain under my left arm (arm I got the vaccine in) lymph... Read more
48 hours after second vaccine I woke up with pain under my left arm (arm I got the vaccine in) lymph node. Sore and tenderness lasted 24 to 36 hours.
59 2021-01-20 swelling face left side of face swelling, especially left eye area and around left side of mouth; This is a sponta... Read more
left side of face swelling, especially left eye area and around left side of mouth; This is a spontaneous report from a contactable nurse. A 59-year-old female patient received second dose of bnt162b2 (BNT162B2, lot number: EKG9231, expiration date: not reported), via an unspecified route of administration, on 12Jan2021 10:00 AM on left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The vaccine was administered at a hospital. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included gerd (Gastroesophageal reflux disease) and allergy to grapefruit. Concomitant medication included esomeprazole magnesium (NEXIUM). The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: Elo 140, expiration date: not reported), via an unspecified route of administration, on 23Dec2020 09:00 AM on left arm for COVID-19 immunization. The patient experienced left side of face swelling, especially left eye area and around left side of mouth, on 13Jan2021 11:00 PM. Since the vaccination, the patient has been tested for COVID-19: Nasal swab on 01Oct2020 (as reported) with negative result. The treatment received for the adverse event was Otc (over-the-counter) Benadryl. Outcome of the event was recovering.
59 2021-01-21 anaphylactic reaction Systemic: Anaphylaxis-Medium, Systemic: Chills-Severe, Systemic: Generalized Body Aches -Medium, Sys... Read more
Systemic: Anaphylaxis-Medium, Systemic: Chills-Severe, Systemic: Generalized Body Aches -Medium, Systemic: Headache-Severe, Systemic: Vomiting-Mild
59 2021-01-21 lymph node swelling, lymph node pain WITHIN 24 HOURS I DEVELOPED A MILD HEADACHE AND THE INJECTION SIGHT IS RED, WARM, SWOLLEN AND THE SI... Read more
WITHIN 24 HOURS I DEVELOPED A MILD HEADACHE AND THE INJECTION SIGHT IS RED, WARM, SWOLLEN AND THE SIZE OF AN HALF DOLLAR. THE LYMPH NODE ON MY RIGHT SIDE IS ALSO SWOLLEN. ON DAY 2, I HAD FLU LIKE SYMPTOMS WITH A FEVER OF 100.8 THAT SUBSIDED WITH TYLENOL. THE INJECTION SITE BECAME ITCHY ON DAY 3 AND IS STILL RED, WARM, SWOLLEN AND THE SIZE OF AN EGG AND MY LYMPH NODE IS STILL SWOLLEN AND SORE.
59 2021-01-21 swelling Received 1st dose of vaccine on 12/21/2020. Developed rash and itchiness on (R) hand between (2) m... Read more
Received 1st dose of vaccine on 12/21/2020. Developed rash and itchiness on (R) hand between (2) middle and (3)ring finger a couple days afterward. Started to go away. Received second dose of COVID-19 on 1/11/2021. Rash continued to worsen. Noticed red rash on neck starting around 1/17/2021. Describes as "just a few red bumps and really itchy". "It felt like poison ivy itching". 1/20/2021, rash appeared to look like hives, swelling, and itchiness intensified. 1/22/2021, swelling subsided some, continues with rash and itchiness.
59 2021-01-24 swelling face Patient received COVID-19 vaccine (unknown which manufacturer or lot) and began noticing swelling in... Read more
Patient received COVID-19 vaccine (unknown which manufacturer or lot) and began noticing swelling in her cheeks and nose nearly immediately. She denies any SOB. Symptoms self resolved in about half an hour and she is currently feeling fine. She does have swelling if she takes Naprosyn containing products. Patient reports vaccine was given on 1/22/21 and second dose is scheduled for 2/15/21 and is not sure if this will be contraindication for her second dose.
59 2021-01-25 lymph node swelling ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/hea... Read more
ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/heavy chest; bad head cold/heavy duty cold; stuffy nose; headache; Swollen glands; Sore throat; Chills; Nausea; Runny nose; This is a spontaneous report from a 'contactable consumer and a physician. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EJT685, expiry date not reported) intramuscular in the left arm on 19Dec2020 at single dose for COVID-19 immunisation. On 11Jan2021, the patient felt tired/very fatigued, had body aches, chest heaviness/heavy chest, bad head cold/heavy duty cold, stuffy nose, headache, swollen glands, sore throat, chills, nausea, runny nose, ears are plugged, and diarrhea. On 12Jan2020, the patient experienced cough and stuffy head. Therapeutic measures were taken as a result of bad head cold. Clinical outcome of the events was unknown.
59 2021-01-26 lymph node swelling swollen lymph nodes under arm of injection; This is a spontaneous report from a contactable other he... Read more
swollen lymph nodes under arm of injection; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular in the right arm on 08Jan2021 10:45 at a single dose for COVID-19 immunization. The patient's medical history included allergies to penicillin and diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient previously took ciprofloxacin (CIPRO) and experienced allergies to ciprofloxacin. The patient had not been tested for COVID-19 since the vaccination. The patient experienced swollen lymph nodes under arm of injection on 11Jan2021 08:00. No treatment was received for the adverse event. Outcome of the event was not recovered.
59 2021-01-26 lymph node swelling Swelling of Lymph nodes under arm on side of injection Chills
59 2021-01-26 lymph node swelling Large, painful cervical adenopathy and painful swallowing limited to L side, onset 1 d after receipt... Read more
Large, painful cervical adenopathy and painful swallowing limited to L side, onset 1 d after receipt, severe X 5 d, cervical adenopathy persistent at d 10
59 2021-01-26 oral herpes nause, stomach cramps, fever blisters, lethargic, weakness
59 2021-01-26 peripheral swelling Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest... Read more
Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest pain; Right calf pain/cramping; Right calf pain/cramping; Fever; Chill; Body aches; Severe headache; Left arm swelling; left arm swelling, redness, knot; left arm swelling, redness, knot; Pain at injection site; Fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 11Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 (COVID prior vaccination: Yes) and known allergies to penicillin and erythromycin. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 07:15, for COVID-19 immunization. The patient experienced shortness of breath w/min exertion, right calf pain/cramping, fever, chill, body aches, severe headache, left arm swelling, redness, knot and pain at injection site, dull chest pain, fatigue, throat tightness/numbness on 11Jan2021. The events resulted to emergency room/department or urgent care visit. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: The 59-year-old patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021, and experienced shortness of breath w/min exertion, dull chest pain, throat tightness/numbness and other symptoms on the same day. Considering plausible temporal relationship, the events were probably related to the second dose of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
59 2021-01-27 lymph node swelling Back and joint pain Lymph node swelling Injection site swellingf Fever
59 2021-01-28 lymph node pain, lymph node swelling Tiredness; mouth sores; it looked red and swollen and it hurt; patient cannot really eat; gum inside... Read more
Tiredness; mouth sores; it looked red and swollen and it hurt; patient cannot really eat; gum inside cheek have white spots on it; it looked red and swollen and it hurt; it looked red and swollen and it hurt; It was more of the cheek inside the mouth, that's painful; It was not open sore but it was just red; Tenderness of lymph nodes/Lymph node is kind of tender; swelling of the lymph node; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: not sure EL3249 or EU3249), via an unspecified route of administration on 11Jan2021 at single dose at left deltoid for covid-19 immunization. Medical history included hypertension, hypothyroidism, heartburn. Concomitant medications included levothyroxine for hypothyroidism, olmesartan, hydrochlorothiazide, amlodipine, omeprazole for heartburn, alprazolam. Patient had the tiredness, mouth sores or something like that in Jan2021. When patient look at her cheek, the gum inside cheek have white spots on it and it looked red and swollen and it hurt, especially the left side and that bothered patient because patient cannot really eat and it hurt. It was more of the cheek inside the mouth, that's painful. It's not open sore but it's just red and like tender. And also patient had a tenderness of lymph nodes on the left neck. For causality, the patient thought so because nothing has changed since before patient got the vaccine. Patient didn't have any of this, especially the sore in the mouth. Patient cannot eat on the left side because it hurt. But the rest of the symptoms which was the tiredness and the swelling of the lymph node, lymph node was kind of tender but it's only on the left side, that's listed as the side effects. But the sores in the mouth was not listed that's why patient was worried about that. Lab work: results were okay. The tiredness, it was like patient got it in the morning, so patient slept. Patient went straight after work, then patient slept. When patient started getting ready for work and the alarm went off, patient was extra tired so I called out sick, but patient was okay. For treatment, patient took naproxen sodium (ALEVE) and then, because patient was at work and yesterday it was really bothering patient because it was hurting. It started hurting really more when the evening was on. Then patient took paracetamol (TYLENOL), then the nystatin solution, patient tried to swish and it helped a little bit with the pain. Due date for the next dose was 08Feb2021. Outcome of events was unknown. Information on the lot/ batch number has been requested.
59 2021-01-28 peripheral swelling Swelling and redness of the arm, the size of an orange; Swelling and redness of the arm, the size of... Read more
Swelling and redness of the arm, the size of an orange; Swelling and redness of the arm, the size of an orange; Headaches; Tiredness; Feeling unwell; This is a spontaneous report from a contactable other health professional. A 59-year-old female patient (pregnant: No) received second dose of bnt162b2 (lot number: EL1283), intramuscularly in left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included sertraline hydrochloride (ZOLOFT), ibuprofen. The patient previous received first dose of bnt162b2 (lot number: EK5730) intramuscularly in left arm on 21Dec2020 11:30 AM for COVID-19 immunization. The patient experienced swelling and redness of the arm, the size of an orange, headaches, tiredness, feeling unwell on 13Jan2021 06:00. No treatment received. The outcome of events was resolving. The event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No covid prior vaccination. No covid tested post vaccination. Not known allergies. Facility type vaccine was hospital. No other vaccine in four weeks.
59 2021-01-31 lymph node swelling Lymphadenopathy, severe Left SI joint and low back pain, including Left leg down to foot. chills,hea... Read more
Lymphadenopathy, severe Left SI joint and low back pain, including Left leg down to foot. chills,headache, nausea, Ibuprofen every 12 hours with Tylenol in between. Warm compresses
59 2021-02-01 lymph node swelling Next day following 2nd dose of Pfizer vaccine, developed a sore left arm at the injection site. that... Read more
Next day following 2nd dose of Pfizer vaccine, developed a sore left arm at the injection site. that evening felt exhausted after work, fell asleep around 6:30 pm woke up around 8 pm and went to bed around 9:30 pm took Aleve for achy body. Friday morning, Jan 27th woke up with left arm pit and side of left breast swollen, tender to touch. and left arm very sore to lift up. Apply cold packs, taking Tylenol and area of tenderness lasting multiple days.
59 2021-02-02 anaphylactic reaction Moderate anaphylaxis 1 hour after the injection which lasted for approximately 10 minutes. Heart p... Read more
Moderate anaphylaxis 1 hour after the injection which lasted for approximately 10 minutes. Heart pain and shortness of breathe which started within 15 minutes of the injection. The heart pains lasted 8-10 days. Headache, fatigue and shooting muscle pains throughout the body starting 2 hours after injection and lasting 8-10 days.
59 2021-02-03 lymph node swelling Due to my personal history of atypical cells in left breast, I had my routine annual MRI the day aft... Read more
Due to my personal history of atypical cells in left breast, I had my routine annual MRI the day after my vaccine booster. the MRI noted two enlarged lymph nodes.
59 2021-02-03 lymph node swelling Swollen lymph node. Noticed breast tenderness the night of receiving vaccine. Breast area tenderne... Read more
Swollen lymph node. Noticed breast tenderness the night of receiving vaccine. Breast area tenderness. Noticed lump Sunday, 1/31 AM. As of today, significantly smaller, but still there. If I had not just had a mammogram, would have thought it was some rapid growing breast cancer.
59 2021-02-03 lymph node swelling Woke with lymphadenopathy and tenderness left supraclavicular area
59 2021-02-04 peripheral swelling Patient reported swelling started in knuckles of both hands 2 days after receiving the vaccine, cont... Read more
Patient reported swelling started in knuckles of both hands 2 days after receiving the vaccine, continued to worsen until date she received the second dose. Described as throbbing, feels like arthritis.
59 2021-02-04 swelling Pain , swelling very achy in ankles and knees for a few days. Later serious pain in hands and finge... Read more
Pain , swelling very achy in ankles and knees for a few days. Later serious pain in hands and fingers, numb feeling, tingling for about a week. Still have.
59 2021-02-06 anaphylactic reaction Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest. T... Read more
Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest. Treatment: dexAMETHasone sodium phos (PF) given at 4:49 pm. diphenhydrAMINE (Benadryl) given at 4:46 pm. famotidine (PEPCID) given at 4:47 pm.
59 2021-02-06 swelling face Extreme headache, nausea, body aches, flushed skin, swelling of face, diarrhea
59 2021-02-06 swelling Pain, swelling (hive), itching, photophobia in Left eye, and pain in injection site Right arm.
59 2021-02-08 peripheral swelling Less than 72 hours after receiving the Pfizer vaccine for COVID-19 I had severe joint pains in my ri... Read more
Less than 72 hours after receiving the Pfizer vaccine for COVID-19 I had severe joint pains in my right hand up into my right elbow and swelling of all my right fingers except my right thumb. It took several days for the symptoms to clear and required that I take one PTO day since I couldn't type or hold a mouse.
59 2021-02-09 oral herpes Charlie horses in legs; multiple cold sores on lip; Chills; Fatigue; headache; cold sweats; This is ... Read more
Charlie horses in legs; multiple cold sores on lip; Chills; Fatigue; headache; cold sweats; This is a spontaneous report from a contactable nurse (patient herself). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unable to locate or read the details), via an unspecified route of administration on 19Jan2021 13:00 at single dose in right arm for COVID-19 immunization. Medical history included psoriasis, high blood pressure, thyroid removal. The patient had no Known allergies. The patient other concomitant medications in two weeks included guselkumab (TREMFYA), levothyroxine sodium (SYNTHROID), aspirin (acetylsalicylic acid), bupropion hydrochloride (WELLBUTRIN), nebivolol hydrochloride (BYSTOLIC). Prior vaccination, the patient had not had COVID, not tested post vaccination. No other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 19Dec2020 at 12:00 PM at single dose in right arm for COVID-19 immunization. The patient experienced charlie horses in legs, multiple cold sores on lip, chills, fatigue, headache, cold sweats on 20Jan2021 07:00. The patient did not received treatment for events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Jan2021. The outcome of the events charlie horses in legs, multiple cold sores on lip, chills, fatigue, headache, cold sweat was recovered in Jan2021. Information on the Lot/Batch number has been requested.
59 2021-02-10 lymph node swelling Painful cervical adenopathy; overlying erythema of skin; Painful swallowing on side of vaccine; This... Read more
Painful cervical adenopathy; overlying erythema of skin; Painful swallowing on side of vaccine; This is a spontaneous report from a contactable physician. A 59-year-old female patient received first dose of intramuscular (PFIZER-BIONTECH COVID-19 VACCINE) on 17Jan2021 at 14:45 at a single dose in left arm for Covid-19 immunisation at the age of 59-year-old. Lot number was EL0142. Medical history included Hashimoto's thyroiditis, Gastrooesophageal reflux disease (GERD), obesity, anxiety, Known allergies (Seasonal pollen, dust, dander). The patient was not pregnant. Historical vaccination included influenza vaccine on 21Dce2020 for immunization. Concomitant medications included aluminium hydroxide gel, dried, magnesium carbonate (PEPCID), sertraline hydrochloride (Zoloft) and lorazepam. On 18Jan2021, the patient experienced painful cervical adenopathy, overlying erythema of skin, painful swallowing on side of vaccine with onset day 1 post vaccine, start of improvement on day 5, the patient was still with adenopathy on day 10. The patient was treated with ibuprofen and acetaminophen. The patient recovered from the events with lasting effects. Prior to vaccination the patient did not have Covid-19; since vaccination the patient was not tested for Covid-19.
59 2021-02-10 lymph node swelling first injection 01/21/2020- resulted in painful left deltoid region- similar to that after a tetanus... Read more
first injection 01/21/2020- resulted in painful left deltoid region- similar to that after a tetanus shot. swelling, pain to touch and pain with movement or when positioned onto that side. decreased over 36-48 hours second injection 02/09/2020 306 pm received injection left deltoid. Awakened at 1237 am 02/10/2020 with chills, inability to get warm, headache, lightheadedness, sensation of heart pounding, nausea and moderate site tenderness. up most of the night. Nausea resolved about 10 hours after the symptoms resolved, remained without appetite. Fatigue, overall just tired, just not feeling well. temp max about 20 hours after onset of symptoms 101.5 temp broke when awakened from sleep in sweat at 327am 02/11/2020. on /2/11/2020 7am mild- moderate intermittent headache persists. Easy fatigue-as an example- fed cat took dog out and was tired and went back to bed.. Appetite better. felt better than I had on 02/10/2020, but not normal. Noted upon awakening is left axillary lymphadenopathy moderate and mild on the right- unable to press arms down to side as increased pain. also supraclavicular tenderness.
59 2021-02-10 swelling face Pt called in our triage line experiencing redness and swelling on Lt. side of face, states had vacci... Read more
Pt called in our triage line experiencing redness and swelling on Lt. side of face, states had vaccine given thru work and did well after administration. Woke up next day with swelling in Lt. side of face and puffiness, tried applying ice but caused itchiness, no other sxs reported. Pt was advised to come in and be seen in clinic for evaluation. pt then was added to the schedule same day 2/11/2021 @ 1:45pm .
59 2021-02-11 lymph node inflammation, axillary mass Dose 1 just got a little red at site of injection & i was a little tired. (was received on 1/18/21 @... Read more
Dose 1 just got a little red at site of injection & i was a little tired. (was received on 1/18/21 @ 9:30am) Dose 2 it got red, hot & a lump at the site of injection. Also, had lump under armpit, was told it was lymphadenopathy, had moderate pain in lower back & mild pain in other joints, also developed fever of 99.4 (my normal temp is 97.4) & chills. This was mostly on the 1st & 2nd day after the vaccine. the swelling under armpit & in arm are better but not completely gone yet & it is now day 4 after the injection (injection on 2/8/21) (was received on 2/8/21 @ 10:37am)
59 2021-02-13 herpes virus infection Herpes outbreak on the 12 day after getting the first Pfizer dose. The outbreak is the same as usual... Read more
Herpes outbreak on the 12 day after getting the first Pfizer dose. The outbreak is the same as usual, but I have been taking antiviral medication for a full year and have had no outbreaks during that time.
59 2021-02-13 lymph node swelling Bilateral shoulder and hip joint pain. Also swollen glands in left shoulder and under arm.
59 2021-02-14 anaphylactic reaction Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; A... Read more
Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL9269), via an unspecified route of administration into left arm on 06Feb2021, at 15:15 as first single dose for covid-19 immunization. Medical history included high blood pressure from an unknown date, known allergies to peanuts, tree nuts from an unknown date (elaborated as allergies to peanuts, non-steroidal-anti-inflammatory drugs (NSAIDs), tree nuts, penicillin), from unknown dates. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) and unspecified multivitamins. No other-vaccines were given with four weeks. On 06Feb2021, at 15:45, the patient experienced adverse event: anaphylaxis reaction. high blood pressure. body shivering. rash on neck and chest. The events were serious as they were life-threatening. The events were noted as resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and was life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included blood pressure measurement: high on 06Feb2021. Therapeutic measures were taken as a result of the adverse events; dexamethasone sodium phos- diphenhydramine (BENADRYL), famotidine. No covid infection was noted prior to vaccination. No covid test has been administered post vaccination. The outcome of events was recovered in Feb2021.
59 2021-02-19 swelling Redness which is hot to touch. Swelling in the same area of redness, firm/hard to touch. This is a c... Read more
Redness which is hot to touch. Swelling in the same area of redness, firm/hard to touch. This is a couple of inches below the injection site. There was no pain or any feeling whatsoever when given the injection.
59 2021-02-23 lymph node swelling, lymph node pain One week after 1st vaccine dose, hard lump from lymph node in Right axillary with general pain/swell... Read more
One week after 1st vaccine dose, hard lump from lymph node in Right axillary with general pain/swelling. About 4 days later lymph node started to soften but the swelling and pain remained. AT time of 2nd dose the swelling and pain were less, but not fully resolved, so dose give in left thigh. Four days after second dose, right axillary lymph node harden with increased pain/swelling. Lymph node soften over the course of a week, but the swelling and pain continues 2 weeks post dose (2/24/21). Treated with lymph-edema message/exercises, ice, and NSAID (Celebrex alternating with Acetaminophen) throughout and continuing.
59 2021-02-24 lymph node swelling, swelling face, swelling Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and ... Read more
Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; elevated heart rate; rash on face, neck and chest; Enlarged lymph nodes; dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on right arm on 09Feb2021 at 15:45 at a single dose for COVID-19 immunisation in the hospital. Medical history was none. The patient had no allergies to medications, food, or other products. Concomitant medications included furosemide (LASIX) and other blood pressure meds (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 09Feb2021, at 16:45 the patient had difficulty breathing, swelling in face, neck, throat and tongue, elevated heart rate, rash on face, neck and chest, enlarged lymph nodes and dizziness. The patient assessed the events as non-serious. Steroids, Benadryl, Pepcid, antibiotics were given as treatment in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the events.
59 2021-02-24 lymph node swelling Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen... Read more
Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen lymph glands right armpit; sore injection site; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 12:30, at single dose, for COVID-19 immunization, at the workplace clinic. Medical history included penicillin allergy, hypertension (HTN), obesity, hypothyroidism, iron deficiency anemia, s/p gastric bypass in 2010 (11 years), and GERD. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. Concomitant medications (other medications in two weeks) included amlodipine benazapril, levothyroxine and pantoprazole. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0140, expiry date: unknown) received at 59 years of age, via an unspecified route of administration on the left arm, on 04Jan2021 12:30, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 26Jan2021 at 01:00, the patient experienced fever 100-103, severe chills, body and joint aches, weakness, fatigue, swollen lymph glands right armpit and sore injection site. The patient was not tested for COVID-19 post vaccination. No treatment was given for the events. The patient was recovering from the events.
59 2021-02-27 swelling face Face turned red for about 2 hours, swollen face
59 2021-02-28 lymph node pain, lymph node swelling fatigue; swollen lymph nodes above the left clavicle that sore; swollen lymph nodes above the left c... Read more
fatigue; swollen lymph nodes above the left clavicle that sore; swollen lymph nodes above the left clavicle that sore; This is a spontaneous report from a contactable health care professional nurse, the patient. A 59-years-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL 3246), via unspecified route of administration in the left arm on 20Jan2021 at 13:00 (at the age of 59-years-old) as a single dose, for COVID-19 vaccination. Medical history included asthma (Chronic Asthma but controlled). The patient had no known allergies. Concomitant medication included Albuterol, Singular, Zyrtec, multi vitamin. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 25Jan2021, The patient experienced fatigue, swollen lymph nodes above the left clavicle that sore. Reported non serious adverse event of fatigue, swollen lymph nodes above the left clavicle that sore and still present on 27Jan2021. No treatment was given for the events. The clinical outcome of the events fatigue, swollen lymph nodes above the left clavicle that sore was not recovered.
59 2021-02-28 peripheral swelling nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest o... Read more
nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest of the body; arm swelling and pain; arm swelling and pain / pain was more severe in the arm; This is a spontaneous report from a contactable health professional, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9263,), via an unspecified route of administration on 26Jan2021 12:00 (at the age of 59-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included penicillin allergy, congenital heart defect. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK4176) on 05Jan2021 at 16:00 (at the age of 59-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 27Jan2021 at 00:00 (on the 2nd day), the patient experienced arm swelling and pain. On 28Jan2021 (the 3rd day), the patient was nauseated, and the pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell. The events resulted in a doctor or other healthcare professional visit. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of arm swelling and pain, nauseated, pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell was not resolved.
59 2021-03-01 swelling felt sick; sore throat with blisters/ vesicles; had a really bad sore throat; tired; achy; her neckl... Read more
felt sick; sore throat with blisters/ vesicles; had a really bad sore throat; tired; achy; her necklines were swollen; redness in back; she was exposed to someone who previously had Covid-19; This is a spontaneous report from a Pfizer-sponsored program and from a Pfizer-sponsored program. A contactable nurse (reporting for herself) reported that a 59-year-old female patient, received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0142), via an unspecified route of administration on 11Jan2021 (at the age of 59) as a single dose for COVID-19 immunization. The patient's medical history included depression from an unknown date. The patient's concomitant medications included duloxetine hydrochloride (CYMBALTA) from an unknown date as an antidepressant. The patient previously received first dose of BNT62B2 (Lot number EJ1685) on 21Dec2020. The patient experienced feeling sick for 3 days after receiving the second dose. The patient may have been exposed to someone who previously had COVID-19 on 27Jan2021 and experienced really bad sore throat with blisters and tiny bubbles on the back of her throat, redness back there and there was little vesicle (called it "Covid throat"); was tired and achy and her necklines were swollen a week later on an unknown date in Feb2021. The patient underwent lab tests which included Rapid COVID Test on 10Feb2021 and 12Feb2021 with negative results; herpes test on an unknown date with negative results and strep test on an unknown date with negative results. Therapeutic measures were taken as a result of the event COVID-19 exposure which included tetracycline on the 10th (stopped on the 12th as the tests negative). The outcome of the events throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19 was unknown. Follow up (16Feb2021): New information received from a contactable healthcare provider and from a Pfizer-sponsored program includes: product details (lot numbers, second dose information), new events (throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19), and lab data.; Sender's Comments: Event blisters and tiny bubbles on the back of throat represents an intercurrent medical condition and unrelated to BNT62B2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
59 2021-03-02 lymph node swelling Pain, swollen gland, flu, chills, tinnitus, fatigue
59 2021-03-03 peripheral swelling her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a ... Read more
her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a lacey honeycomb pattern of red with white blotches; her cheeks were bright red; top of her hands to her wrist and lower arms were very red; felt light headed/faint and dizzy; tightness in her chest; the tightness that she felt the day before was in her lungs or throat; This is a spontaneous report from a contactable Physician reporting for his/her sister. A 59-year-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration at single dose in Jan2021 (12 days before reporting) for COVID-19 immunisation. Medical history included Hashimoto's autoimmune disease, enlarged thyroid, goitre. The patient's concomitant medications were not reported. In Jan2021, as soon as she got the injection, the patient felt both her hands swelling and tightness, underside of the forearms had a lacey honeycomb pattern of red with white blotches, top of her hands to her wrist and lower arms were very red, her cheeks were bright red, felt light headed/faint and dizzy, tightness in her chest and thought it was her heart. She was monitored for an hour but was told it probably wasn't an allergic reaction. Symptoms began to fade at that time. Next day she felt good and thought the tightness that she felt the day before was in her lungs or throat. The outcome of events was recovering. The events were reported as non serious. Reporter was referred to HCP or vaccination provider to determine if this was a severe allergic reaction and if she should receive the second dose of the vaccine. Information on the lot/batch number has been requested.
59 2021-03-06 lymph node swelling Headache, bodyache, chills lasted two days. Sore arm at shot, swollen lymph nodes under arm still th... Read more
Headache, bodyache, chills lasted two days. Sore arm at shot, swollen lymph nodes under arm still there.
59 2021-03-07 anaphylactic shock Anaphylactic shock - throat restricting, tongue swelling, racing heart, rash predominantly on chest ... Read more
Anaphylactic shock - throat restricting, tongue swelling, racing heart, rash predominantly on chest and neck. PB was elevated, dizzy, weak. Symptoms escalated quickly. Immediately flagged help from nearby medic.
59 2021-03-07 lymph node pain, lymph node swelling Lymph nodes under same arm as injection was received are swollen and painful.
59 2021-03-07 oral herpes Breakout of 4 cold sores lower left lip despite 400mg daily prophylactic acyclovir.; This is a spont... Read more
Breakout of 4 cold sores lower left lip despite 400mg daily prophylactic acyclovir.; This is a spontaneous report from a contactable nurse. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK4176, intramuscular in the left arm, on 22Jan2021 15:00 at SINGLE DOSE for covid-19 immunization. Medical history included depression, SEM, Herpes Simplex 3 and BET. Concomitant medications included sertraline, clonazepam and propranolol. The patient also had thiomersal allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 25Jan2021, the patient experienced breakout of 4 cold sores lower left lip despite 400mg daily prophylactic acyclovir. The outcome of event was recovered. Follow-up attempts are completed. The information on the batch/lot number has been obtained.
59 2021-03-07 peripheral swelling Swelling under are, size of 1/2 baseball. Sore and painful. Resolving
59 2021-03-09 lymph node swelling Lymph node swelling in left armpit
59 2021-03-09 lymph node swelling Left arm under armpit very sore including swollen lymph nodes.
59 2021-03-10 axillary mass Tired and a sore lump under my left armpit.
59 2021-03-10 swelling Distal tingling x 4 extremities, swelling, erythema of posterior pharynx, able to swallow saliva, no... Read more
Distal tingling x 4 extremities, swelling, erythema of posterior pharynx, able to swallow saliva, no tongue, lip or facial swelling, heart rate 90, respirations 16, lungs clear, 50 mg of Benadryl administered IM right deltoid at 11:33 AM with good effect, transported to the Medical Center via ambulance with advanced life support capability at 11:52 AM.
59 2021-03-10 white blood cell count increased I began to feel ill on that Wednesday morning. I had had a bilateral mastectomy in Nov of 2020, and ... Read more
I began to feel ill on that Wednesday morning. I had had a bilateral mastectomy in Nov of 2020, and tissue expanders are still in place. I reached a fever of 103.6 and had pain and extreme redness in my right tissue expander. I also had all axillary lymph nodes removed from that side in December 2020. On Friday I was still feeling ill and noticed redness, so I immediately contacted my doctor and was instructed to meet him at the hospital. I was admitted and placed on antibiotics and had my tissue expander removed The next morning after no improvement from antibiotic infusion. I had a wound vac placed and stayed in the hospital for one week and had my expander replaced on that following Saturday. I am not planning on taking the second shot.
59 2021-03-11 lymph node swelling Pfizer-BioNTech CoVID-19 Vaccine . Routine Office visit 3/11/21 with surgeon, previous melanoma as... Read more
Pfizer-BioNTech CoVID-19 Vaccine . Routine Office visit 3/11/21 with surgeon, previous melanoma as follow up. She advised my lymph nodes were swollen on the right side in my groin and under my arm. I also received my COVID vaccine in my right arm. Doctor will do another follow up in 30 days on 4/15/21.
59 2021-03-11 swelling face 9 hours after injection, injection site started to swell significantly. after putting a cool towel a... Read more
9 hours after injection, injection site started to swell significantly. after putting a cool towel and then trying to put covered ice pack, started having significant joint and muscle and scar tissue pain in hands knee and feet and hip. Then bicep muscles tensed up in both arms and then relaxed several times, as well as pain in collarbone and tightness up neck as well as swelling of face and top lip. I did not know if I was going to have a stroke and if I needed to go to an emergency room but the symptoms subsided. Some diarrhea next day. I understand from my therapist that multiple people have reported the significant muscle issues and it is not printed anywhere as a side effect which would help.
59 2021-03-13 swelling I already filled out a AE report on 3/5 but I need to amend to add diarrhea that had not stopped. I ... Read more
I already filled out a AE report on 3/5 but I need to amend to add diarrhea that had not stopped. I had to go to Urgent Care on 3/13 for IV fluids and still feeling sick all-over, headaches and muscle aches. Tested negative for Covid at Urgent Care. Initial report included headaches, body aches, injection site pain, swelling and bruising.,feeling sick all-over.
59 2021-03-14 lymph node swelling, peripheral swelling A lump appeared under the armpit (golf-ball sized). It is painful. Also appearing on upper arm on th... Read more
A lump appeared under the armpit (golf-ball sized). It is painful. Also appearing on upper arm on the same side (on inside of arm). No color.
59 2021-03-14 peripheral swelling 03/04/21 - pain, swelling, redness , left arm 03/05/21 - pain, swelling, redness , left arm, fever... Read more
03/04/21 - pain, swelling, redness , left arm 03/05/21 - pain, swelling, redness , left arm, fever 101 03/06/21 - pain, swelling, redness , left arm, fever 100 - 101, fever varied 03/07/21-03/14/21 - itchy left arm , pain left arm, fatigue, loss of appetite, dizziness 03/15/21 - fatigue, dizziness, general body aches
59 2021-03-15 lymph node swelling, axillary mass Right underarm lymph nodes swollen and is a large mass. It is still swollen. I noticed it on Sunday,... Read more
Right underarm lymph nodes swollen and is a large mass. It is still swollen. I noticed it on Sunday, 3-14. I received my first Covid shot on Friday, 3-12, and my underarm is still swollen today, 3-16-21.
59 2021-03-17 anaphylactic reaction Anaphylaxis - Diffculty breathing, chest heaviness, wheezing Reaction began 1:05 pm, Admitted to ER ... Read more
Anaphylaxis - Diffculty breathing, chest heaviness, wheezing Reaction began 1:05 pm, Admitted to ER at 1:52, Released at 4:00 pm
59 2021-03-17 lymph node swelling Woke on the morning after the shot 2/27/21 with a low grade fever (100), fatigue, headache, joint an... Read more
Woke on the morning after the shot 2/27/21 with a low grade fever (100), fatigue, headache, joint and muscle pain and slightly swollen lymph nodes in my neck. Within a few hours, my body was completely covered in large hives from head to toe. I rested or slept most of the day and by the afternoon, the fever had subsided. By the next day headache, joint/muscle pain and swollen lymph nodes diminished. I still felt fatigue and the hives were awful. Began taking Benadryl with no relief. Called my primary care doctor to report; increased Benadryl dosage to 2 every 4 hours. There was some relief during the day, but the large doses of benadryl were making me anxious/nervous, racing heart, shakes. Decreased following another call to Doctor and began taking Antronex; decreaed side effects, but little affect on the hives during the evening/overnight hours. At times I would be completely covered in them, other times they were localized (bottoms of my feet, face, neck, eyes). Returned call to Doctor, again suggested Prednisone. (I typically have strong reactions to steriods and wanted to avoid if at all possible) Began first dose 3/18/2021. Experiencing some relief already.
59 2021-03-18 lymph node swelling Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and l... Read more
Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and lips and hardening of lymph gland in left chest. This lasted for hours. Injection site pain only lasted about 24 hours. Since then, I still have numbness on the right side top of head and intermittent EXTREME tinnitus that interferes with my ability to concentrate, communicate and sleep. It comes and goes but the volume is beyond anything I have ever experienced. Then it goes away. The right side of my head has stayed numb. Will this go away? Should I get the 2nd dose or not?
59 2021-03-18 lymph node swelling Had Covid fairly bad I got pneumonia with it; Super tired; 103 to 104.6 fever; Glands in neck and un... Read more
Had Covid fairly bad I got pneumonia with it; Super tired; 103 to 104.6 fever; Glands in neck and under arm on the side where got the shot swelled up; hurt quite badly; huge swollen lymph nodes; Body ache; Could barely walk; could walk to shuffle my feet; joints stiff; Horrible headaches; Diarrhea; I was dizzy and foggy; Night I break out into a horrible sweat in night like I have to change my pajamas twice; I am like wet; Arm sore/My arm was just little bit sore; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot Number: EN6202) (at the age of 59) as a single dose, for covid-19 immunisation. Medical history included an unspecified heart condition and a flu shot un an unspecified date. Concomitant medications included levothyroxine sodium (SYNTHROID) and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE). The patient stated, "I am calling about the side effects I had from my Covid shot vaccine. I am concerned about getting the second one because my reaction was so big. I got it on Saturday, this past Saturday about 12:45 I think 12:30 and I did fine, the shot didn't hurt at all. That night I was a little bit tired but that's it. My arm was just little bit sore. The next day I got up, I still felt good I went to work for 2 hours and then about 12 o'clock it hit me all at once. This Sunday I ran anywhere from a 103 to 104.6 fever and that was me taking Tylenol and I took Tylenol every 4 hour because my fever was still high. The glands in my neck and the glands under my arm on the side where I got the shot swelled up, they are still swollen. My whole body ached. I had Covid fairly bad I got pneumonia with it all for "two weeks" (not clarified) but my fever was not as high as got with the shot, the vaccine like I could barely walk after the vaccine because my joints were so stiff only way I could walk was to shuffle my feet, it was horrible. I had a fever yesterday all day but it was only in the 102.3 and 4, it never went back to 103. Glands in my arm and my neck hurt quite badly. My arm where I got it, it wasn't swollen but I get the same reaction when I get a Flu shot (unspecified shot) so that's not a big deal. I got horrible headaches. I had diarrhea all day Sunday and yesterday and so this morning my fever is only right around 101 like 101.1, 101.2, I am still super tired and also yesterday and day before I was dizzy and foggy. I still have a slight fever today. My lymph nodes are still swollen, my neck and under my arm, my arm where I got the shot is still swollen and sore but I can tolerate that. My joints are stiff a little bit but not nearly as bad as they were, so I don't know if I should get the second shot, everyone says the second shot is worst like all those heart palpitations start with it as well." One of my other symptom is at night I break out into a horrible sweat like I have to change my pajamas twice. It was last night and the night before. I am like really wet." The outcome of the events was not reported.
59 2021-03-18 swelling face Swelling to upper lip and around nose. Tongue tingling. Patient given 25mg of liquid Benadryl. Withi... Read more
Swelling to upper lip and around nose. Tongue tingling. Patient given 25mg of liquid Benadryl. Within approximately 20 minutes the patient's swelling began to subside. Patient felt better and tongue was no longer tingling.
59 2021-03-19 lymph node swelling Swollen lymph node on collar bone, went to ER, they did ultrasound and chest x-ray on 01-11-21 sugge... Read more
Swollen lymph node on collar bone, went to ER, they did ultrasound and chest x-ray on 01-11-21 suggested follow up with doctor. 1/14/21 saw the doctor. He recommended a CT scan. The CT scan was completed on 1-29-21 and found multiple swollen lymph nodes throughout neck and chest. A biopsy was ordered. A needle biopsy was performed on the swollen lymph node on the collar bone on 2-2-21. No cancer was found. It was recommended to observe and wait and redo in 3 months if necessary. The swelling has been gradually lessening and is almost gone.
59 2021-03-20 peripheral swelling Left leg swollen,veins in leg very pronounced,leg aching,bruising to arms and legs,right lower leg b... Read more
Left leg swollen,veins in leg very pronounced,leg aching,bruising to arms and legs,right lower leg bright red spots appeared ,headache very bad,back of head hurting like a baseball bat had whacked it,
59 2021-03-21 lymph node swelling 8 days after the vaccine, my left upper arm at the site of the injection began to feel itchy and unc... Read more
8 days after the vaccine, my left upper arm at the site of the injection began to feel itchy and uncomfortable. On day 9, a red circular, itchy rash appeared. This expanded on day 10 (today). It is sore, itchy, red, has bumps, and my lymph node under my left armpit may be enlarged. Shoulder is slightly uncomfortable.
59 2021-03-22 lymph node swelling The lymph node on my collar bone on the same side, the left as both doses of my vaccine. After the s... Read more
The lymph node on my collar bone on the same side, the left as both doses of my vaccine. After the second dose the lymph node became more enlarged. It is the size of a marble that is still noticeable after eleven weeks. I am due to get an Ultrasound on the area to access the problem. Besides that, I just had mild headaches and tiredness for a short period. Second dose numberEL0142
59 2021-03-22 swelling face Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM... Read more
Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM I started to get very red and my face was swollen then I started to have a difficultly in breathing then I felt dizzy and I had a high fever and I started vomiting. and my blood pressure was very high. Then I called 911 and I was transferred to the Emergency hospital.
59 2021-03-23 lymph node swelling Swollen lymph node over left clavicle.
59 2021-03-24 lymph node swelling swollen lymph nodes under arm patient is taking Aleve for symptoms, recommended HCF eval if sx pers... Read more
swollen lymph nodes under arm patient is taking Aleve for symptoms, recommended HCF eval if sx persist
59 2021-03-24 lymph node swelling On March 10th I felt pain in my right armpit for 36 hours and the lymph nodes were swollen in my arm... Read more
On March 10th I felt pain in my right armpit for 36 hours and the lymph nodes were swollen in my armpit. On the evening of March 10th I felt tired and unwell similar to having the flu. The next morning the flu like symptoms were gone
59 2021-03-24 lymph node swelling Went for mammogram the week following vaccination and had swollen lymph nodes in the armpit area. W... Read more
Went for mammogram the week following vaccination and had swollen lymph nodes in the armpit area. Was told that other women were experiencing the same thing.
59 2021-03-26 anaphylactic reaction Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Dif... Read more
Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: Eye ball rotating
59 2021-03-26 lymph node swelling, swelling Swelling at the neck, over left clavicle . Painful to touch. Lymphoid seem to be enlarged
59 2021-03-26 lymph node swelling 3 hours after shot I hit metallic taste in my mouth, I then became so severely tired and light heade... Read more
3 hours after shot I hit metallic taste in my mouth, I then became so severely tired and light headed. Got chills. Hot & cold nauseated . It?s three days later I?m still very tired. Headaches , throats feels swollen , glands swollen. I feel like I got the flu! When is this going to end ?
59 2021-03-27 oral herpes High temp for two days after shot and then low grade temp for three days Headache Nausea Chills Bo... Read more
High temp for two days after shot and then low grade temp for three days Headache Nausea Chills Body aches Joints hurt Left eye became bloodshot and hurt Cold sores inside and outside of mout
59 2021-03-28 lymph node swelling, fluid retention First Vaccine received on Feb. 28, 2021 in right arm with mild fever and lethargy beginning around s... Read more
First Vaccine received on Feb. 28, 2021 in right arm with mild fever and lethargy beginning around six hours after injection and lasting for several days-manageable with Tylenol. Second Vaccine received on March 22, 2021: very small amount of soreness in left arm for first day. Begun to feel ill after about 15 hours. Fever of 100 with major body aches and chills for about 24 hours after this, not managed by Tylenol this time. Forty-eight hours after the injection the soreness at the injection site was minimal but there was major swelling and pain in the lymph nodes underneath the left arm as well as general fluid retention all over ( five pound weight gain overnight). This swelling and pain was also present in the left chest area and continued for about four days with extreme discomfort. At this point, one week after the injection, the pain and swelling in the left armpit is reduced to mild discomfort and fluid retention has also reduced.
59 2021-03-28 lymph node swelling, lymph node pain Painful, swollen lymph node under the jaw, left side Painful lymph node near armpit, left side Extre... Read more
Painful, swollen lymph node under the jaw, left side Painful lymph node near armpit, left side Extreme fatigue
59 2021-03-28 swelling Local swelling and soreness at injection site Difficulty sleeping following injection for one night
59 2021-03-29 c-reactive protein increased Previously well woman with no history of knee arthritis or dermatitis. 13 days after vaccine adminis... Read more
Previously well woman with no history of knee arthritis or dermatitis. 13 days after vaccine administration, began to experience myalgias, arthralgias (especially knees, shoulders), fatigue, conjunctival injection, papular rash to L arm>trunk and other extremities. Day 17 after vaccine, seen in ED for above symptoms with neg COVID, HIV, Hepatitis testing. Day 21 after vaccine, seen again in office with persistent arthralgias, noted to have ESR and CRP elevated, returning to normal by 34 days after vaccine. Seen by me on day 47 after vaccination with persistent fatigue, mental fog, and arthralgias in knees.
59 2021-03-29 oral herpes A cold sore developed just above my lip, on the right side. I typically get one maybe once every two... Read more
A cold sore developed just above my lip, on the right side. I typically get one maybe once every two years. This seems to have come out of nowhere. Not sure if the vaccine activated the virus or this is cirumstantial.
59 2021-03-30 lymph node swelling Delayed reactions: 6 days after shot, swollen & painful lymph nodes under left arm Delayed reactions... Read more
Delayed reactions: 6 days after shot, swollen & painful lymph nodes under left arm Delayed reactions: 9 days after shot, hot, red, painful swelling at injection site on left arm, approximately 2" diameter Patient using ice, Tylenol, and Benadryl to manage symptoms
59 2021-03-30 swelling face Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of ... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: swelling in mouth - tongue/throat. white spots on lip/mouth. vaccine given 11:07, sx started ~11:17, benadryl given 11:20, EMS arrived 11:34. Patient was fine and stable, left with husband a few minutes later. counseled on what to do if symptoms reemerge.
59 2021-03-31 swelling face Pt received 1st Dose of Pfizer vaccine on 03/29/21. Mother reported that patient began to experience... Read more
Pt received 1st Dose of Pfizer vaccine on 03/29/21. Mother reported that patient began to experience Fever; Drooping & Swelling on right side of face on 03/30/21. Swelling is decreasing but there is still some drooping. The patient is Epileptic and is also taking Dilantin and Phenobarbital to control the seizures.
59 2021-04-01 swelling face At vaccine center, patient reported shortness of breath and facial swelling. Epi pen given and patie... Read more
At vaccine center, patient reported shortness of breath and facial swelling. Epi pen given and patient went to the ED.
59 2021-04-02 peripheral swelling Pain and swelling in lower legs (anterior compartment syndrome) which began on 3/15/21, 5 days after... Read more
Pain and swelling in lower legs (anterior compartment syndrome) which began on 3/15/21, 5 days after vaccination. Pain and swelling continue without abating after 2 weeks of rest, compression, ice, elevation. Stye in left eye - possibly due to inflammation in eyes. Treating with moist heat.
59 2021-04-03 lymph node swelling Swollen lymph node in armpit; injection site arm
59 2021-04-03 swelling face Patient reports around midnight the day of 1st covid vaccine that she felt a sensation in her face, ... Read more
Patient reports around midnight the day of 1st covid vaccine that she felt a sensation in her face, and began to get swelling and rash on right side of face. She states that it progressively got worse. Upon waking patient took a Benadryl tablet, and came to the pharmacy to get further direction. Initially on 3/17/21 she was directed to call primary care doctor (who is located about an hour from home) and if symptoms worsened or she started having issues around mouth or trouble breathing seek an urgent care or emergency room. Patient reported on 4/3/2021 that she had contacted doctor and they wanted her to continue the benadryl until resolved but did not believe that the reaction warranted a steroid and instructed that she could get second dose of vaccine.
59 2021-04-04 lymph node swelling, lymph node pain I developed what I believe to be a swollen lymph node on my neck just above my collar bone on the sa... Read more
I developed what I believe to be a swollen lymph node on my neck just above my collar bone on the same side of where I received my shot. It was small after the first dose and became larger and painful after the 2nd dose. This concerns me.
59 2021-04-04 peripheral swelling 25 minutes Post injection: Left eye issues. Itchy, swollen behind the eye and feeling like something... Read more
25 minutes Post injection: Left eye issues. Itchy, swollen behind the eye and feeling like something was in it or irritating it. It kept driving me to check if something was in it. I put in renu eye drops and did not think any more of it. 40 minutes post injection: both feet red and swollen left foot about half of the top, the whole right foot looked like a giant hive or welted area across the whole top of foot. The injection site began being quite sore, and it also looked welted and felt hot to the touch. I kept checking my left rib cage and my left thumb as I was sure there was going to be hives, because I could not stop rubbing or scratching them as they itched so badly. I continued itching and feeling weird tingly sensations and either rubbed or scratched these areas to no avail. Even my head itched terribly by the second day. 45 minutes post injection: Tightness and scratchiness in throat appeared and my throat was sore, my voice began going out and my voice got hoarse. There was about a two inch area of my throat in which I felt I needed to keep trying to clear something that was stuck. (This made no sense to me as I was able to drink water without any issues.) I had a slight cough every time I stopped drinking, so I continually drank water while I was not trying to sleep. My chest was tight, but because I have asthma I took albuterol and thought nothing of it. (This really did not help, but I did not get worse either.) About an hour after the shot, I constantly felt on the verge of shaking, much like when you have a fever, but I did not think to check my temperature until the following morning when I was extremely tired, felt like I had a sinus headache and possibly did have a fever. My temperature was 99.4 degrees farenheight. At this point, I felt very flu-ish and achy. My armpit area hurt a lot and I chewed two aspirin. I experienced wheeziness, chest tightness, and hoarseness the second and third day as well. I had the morning congestion and stuffiness as well as the need to keep clearing my voice still as of this morning but to much less degree as the initial onset. The skin itchiness is still ongoing, but to a much lesser degree than previously had.
59 2021-04-05 lymph node swelling, lymph node pain Woke up last night with a large swollen lymph node near my left collar bone (shot was in left arm). ... Read more
Woke up last night with a large swollen lymph node near my left collar bone (shot was in left arm). I can't get in to see my health care provider until the 14th of April. I am under care of a Naturopath in the meantime--castor oil packs, warmth, and tomorrow, some lymphatic herbs. No history of breast cancer. It's painful but not unbearable. Thought it important that this is recorded, though I expect to be fine--I wish I had heard about it before I went looking for it online as a possibility, though.
59 2021-04-05 lymph node swelling Lymph node swelling and discomfort in left arm pit, heart palpitations, joint discomfort.
59 2021-04-05 peripheral swelling Injection at 9:55 am. Itchy eyes and root of mouth started 15 minutes after injection. I waited for... Read more
Injection at 9:55 am. Itchy eyes and root of mouth started 15 minutes after injection. I waited for an additional 15 minutes at facility and the symptoms went away on their own. At 12 noon at home malaise set in. I rested off and on for the remainder of the day. At 4 pm, pain and swelling in right arm. No treatment. Also, at the same time pain in vaginal area started. Pain remained for remainder of the evening and night. The next morning the pain had lessened some, however not totally. I can not think of any cause for the vaginal pain, just that it started several hours after vaccine was administered.
59 2021-04-05 swelling, swelling face, anaphylactic reaction anaphylaxis response Swelling of neck/face/eyes, difficulty in breathing
59 2021-04-06 swelling face Started to feel little light headed they gave me ice water about 12 minutes after shot, at 30 went t... Read more
Started to feel little light headed they gave me ice water about 12 minutes after shot, at 30 went to car .when took off mask my cheeks where fire engine red and quite swollen, mouth was feeling tingly, went back to facility, nurse said to take my Benadryl and if gets worse call doctor,. My face stayed swollen and sides of neck got red and pills felt stuck deep in back of my throat. Started taking Zyrtec,Allegra,Benadryl in a rotation every 2-3 hours in between, could take up to 4 doses of each anti histime in a day. nurse practitioner 4/2 11:30am, she added 2 doses of Pe I?d to the rotation. I continue to have face/mouth swelling intermittently and pills still feel stuck in my throat. Arm swelled day for at injection site with a sand dollar size red rash:pain ful. On 4/2-4/4 had horrible headache..
59 2021-04-07 lymph node swelling Red, swollen, very sore, hot nickel size welt at injection point 24 hours after injection. It grew t... Read more
Red, swollen, very sore, hot nickel size welt at injection point 24 hours after injection. It grew to the size of a half dollar, still swollen and sore. Lymph nodes were swollen and sore at armpit. Now 48 hours symptoms are nearly subsided. Just thought you'd like to know.
59 2021-04-08 lymph node swelling 1st, cramping legs, 2nd- nausea-3rd-very tired- 4th sm headache-5th sore body,- 6th next day (4-8-2... Read more
1st, cramping legs, 2nd- nausea-3rd-very tired- 4th sm headache-5th sore body,- 6th next day (4-8-21) right armpit lymph node hurts- swollen
59 2021-04-08 swelling face, swelling Ears filled with fluid, tongue swelling, lips swelling, face and neck swelling, rash all over body, ... Read more
Ears filled with fluid, tongue swelling, lips swelling, face and neck swelling, rash all over body, itch all over body, burning skin after 1 week. Multiple episodes (at least 10) over the course of 3 weeks - resulted in 3 trips to the ER. Received injected or oral steroids at the ER. This caused loss of work and a great deal of stress. Was put on a course of oral steroids and antihistamines by allergist following ER visits. Had a prior reaction to the flu shot in October 2020. Everything above but the rash and itching. also resulted in a trip to the ER
59 2021-04-08 swelling face Pt. received her 2nd dose of the vaccine and while waiting in the pod she complained the left side ... Read more
Pt. received her 2nd dose of the vaccine and while waiting in the pod she complained the left side of her tongue was tingling. She was given some water to sip. Then stated that she felt her left cheek droop and her left eye is not focusing as well as before. Stated she did not have a reaction after her first dose. A droop was not noted on her face. Pt. initially refused (thought it would take too long) but then agreed to be taken to the E.D. and ambulated instead of using a w/c. Upon arrival, she stated that her tingling seemed to have worsened and it was now on her buttocks, she reported to an RN who came to triage her.
59 2021-04-09 lymph node swelling On Thursday, April 8th, a little over 24 hrs after my second dose, I noticed my left arm felt stiff... Read more
On Thursday, April 8th, a little over 24 hrs after my second dose, I noticed my left arm felt stiff and sore. I realized the source of pain was from my underarm , the pit felt swollen and very quickly I could not lift my arm up nor out to the side. I used a microwaveable heating pad both Thursday and Friday night. Today is Saturday and it is about 75% better although it is still sore to touch. I do suffer with fibromyalgia and if not for the armpit swell, and how quickly it all progressed, I would have thought it was ?frozen shoulder?, something I have experienced before. There did also feel like a big knot in the pit and the muscle was ver painful to touch as well as felt like a knot was in it too.
59 2021-04-10 lymph node swelling Swollen lymph node under arm pit if injection site arm
59 2021-04-10 lymph node swelling Could taste the injection in the back of my throat and nasal cavities soon after the injection. Neck... Read more
Could taste the injection in the back of my throat and nasal cavities soon after the injection. Neck felt swollen as I was getting in my car to leave Mild headache early evening and into the following day Developed Itchy Rash by bedtime: upper chest and back and base of neck - which is the reason that I am submitting this form. The rash is still itchy. Have used OTC allergy meds and calamine spray
59 2021-04-11 lymph node swelling swollen lymph nodes under arm and by neck
59 2021-04-12 lymph node swelling, lymph node pain Swollen and tender lymph nodes in left armpit
59 2021-04-12 lymph node swelling 7 days after my 1st Pfizer shot I developed a "vaccine arm" (red, raised skin rash on the left arm a... Read more
7 days after my 1st Pfizer shot I developed a "vaccine arm" (red, raised skin rash on the left arm around the injection point. The size was about 2 inches in diameter. I also felt swollen lymph nodes under my arm in the armpit area. Both the skin rash and the swollen lymph nodes lasted for about 1 week and gradually went away.
59 2021-04-13 fluid retention I received the vaccine on March 24, on a Blue Day, when I was physically at work. I stayed in the o... Read more
I received the vaccine on March 24, on a Blue Day, when I was physically at work. I stayed in the office until 5:00 pm and felt normal. I could feel the place of the injection, but that was all. The next day, March 25, I worked from home. I woke up with a medium pain in the arm at the place of the injection and with a headache. I said to myself, these are normal reactions following the vaccine. The headache did not go away, although I took a Ibuprofen rapid tablet of 400 mg. In the afternoon I checked my blood pressure and it was 171/90 and the pulse 86. I took immediately additional blood pressure medicine (Captopril and Tertensif) to lower it. In 2 hours it lowered it to 166/89 P81, at the advice of my physician, whom I called, I took the medicine I take for blood pressure Atacand and a pill to eliminate the water in the body. Finally at 9:00 pm the blood pressure measured 149/81 P71. On March 26 I came to work, with my blood pressure device, and at noon it was 198/94 P95. I took two pills of Atacand and Furosemid and I came to the physician measured a blood pressure of 159/95, and subsequently 144/86. She did an EKG which was normal. On March 27, Saturday the blood pressure ranged between 132/74 P72 in the morning and 104/60 P 65 in the evening, taking only my usual medication for blood pressure. And since then my blood pressure returned to normal taking only my usual treatment. On March 29 I went to my cardiologist who examined me and did not find anything out of the ordinary, told me to continue with the same treatment, and monitor the blood pressure twice a day. She of course, as anyone else, could not say it was due to the vaccine, but she could not dismiss the fact that maybe the vaccine had an influence over the blood pressure. She encouraged me to take also the second dose of the vaccine.
59 2021-04-13 peripheral swelling Fever 101º/ Extreme Chills (3 days) Stomach ache (5 days) Strange/adverse sense of smell (3 days) S... Read more
Fever 101º/ Extreme Chills (3 days) Stomach ache (5 days) Strange/adverse sense of smell (3 days) Strange/adverse sense of taste (3 days) EXTREME lethargy /sleepiness (10 days) Aggravation of arthritis in left knee (could not walk normally for 8 day, but the condition still persists and now includes swelling) Loss of use of left arm - no range of motion, pain, etc. (ONGOING) Numbness of left leg in various stages (ONGOING) Complete numbness of left leg with sudden loss of use of left leg, resulting in a fall (March 27, 2021) Shoulder swelling in muscle at the front of left shoulder, resulting in pain with use of arm (ONGOING).
59 2021-04-15 swelling face Started with headache about 20 minutes after shot, then gradually over the next 45 minutes itchy & ... Read more
Started with headache about 20 minutes after shot, then gradually over the next 45 minutes itchy & puffy upper lip, cheeks, eyelids, tightness at back of mouth. all cleared up about 45 minutes after onset so all lasted about 1.5 hours
59 2021-04-15 swelling face Symptoms within a few minutes of vaccine administration: body aches and headaches (although these tw... Read more
Symptoms within a few minutes of vaccine administration: body aches and headaches (although these two specifically are not uncommon for pt), jaw pain, left arm shaking until bedtime that night, twitching (also not uncommon for pt per seizure disorder). Symptoms resolved by next morning at 7am, but within 2 hours, symptoms returned, including swollen face that is painful to the touch, intense fatigue, burning/throbbing/tingling sensation in arms and legs, worsening of arthritic pain, jaw pain, chills/hot flash-like episodes, decreased appetite, stinging sensation in the eye, home measurement had pulse ox 98% and HR at 93 bpm (pt endorsed). Note that pt was COVID positive on Dec 1st, 2020
59 2021-04-16 peripheral swelling I have Rheumatory arthritis and since my second shot I have had a major flare up. Five days after th... Read more
I have Rheumatory arthritis and since my second shot I have had a major flare up. Five days after the shot I have developed swelling and unable to use my right arm and hand also extreme rib pain. It has been many years since ive had such pain. I also have a broken heel (unheeling due to arthritis} that has become very painful
59 2021-04-16 swelling face, anaphylactic reaction Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient waited in the observation area after getting vaccinated for 15 minutes, went home and started feeling anaphylactic symptoms around 30 minutes after and drove back to the pharmacy to seek medical attention. She was panicked and hyperventilating upon arrival and I had the patient sit down and to take deep breaths. I was about to give her benadryl but she complained of swollen throat and having a hard time breathing. I injected her with epi-pen and within 5 minutes she was better.
59 2021-04-17 swelling face Facial swelling and numbness
59 2021-04-17 white blood cell count increased she was in distress with her throat starting to swell, her tongue started to swell and she was cover... Read more
she was in distress with her throat starting to swell, her tongue started to swell and she was covered with the hives and rash from head to toe.; her lips and tongue began to swell; her lips and tongue began to swell; rash on her palms, hands, elbows, and left hip/rash all over her body; elbows were red; hive rash on her palm and hand and elbows and it was strange and her elbows were red and were itchy on the palms like red and itchy; developed hives/rash on her palms, hands, elbows, and left hip; WBC count was high; liver was not doing great; post COVID vaccine delayed allergic reaction; pain in her right ear; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:15 (Batch/Lot Number: EL9266) as SINGLE DOSE for covid-19 immunisation. Medical history included arrhythmia, ear infection. Concomitant medication(s) included propranolol (PROPANOLOL [PROPRANOLOL]) taken for arrhythmia from Apr2020 to an unspecified stop date. The patient previously took augmentin [amoxicillin;clavulanic acid] for ear pain and experienced rash on her elbows and palm and arm. Caller stated on Friday 05Mar2021, which was the 11th day after getting the Pfizer COVID Vaccine although she noticed symptoms on the 10th day 04Mar2021 after receiving the vaccine, states she noticed she had a hive rash on her palm and hand and elbows/rash on her palms, hands, elbows, and left hip and it was strange and her elbows were red and were itchy on the palms like red and itchy and she could see the rash starting on the left inside forearm; from there as the day wore on into the next day the rash became worse and more areas of the body were covered with the rash. States she made an appointment on that Monday morning with her HCP and had gone into the HCP office at that time; states on 08Mar2021, she was in distress with her throat starting to swell, her tongue started to swell/ her lips and tongue began to swell and she was covered with the hives and rash from head to toe. Caller states she was started on Prednisone at her HCP office and it was one of those dose packs; states she has no lot numbers to provide. Later on that evening she needed to go to the emergency room and she had become more severe and had a big dose of Prednisone at the emergency room and at that time the HCP there did believe she was having what is considered a post COVID vaccine delayed allergic reaction and hives; states she was in the emergency room early and was there past midnight and thinks she presented to the emergency room on 09Mar2021 and then most recent results she has of her paperwork were from 09Mar2021 to 10Mar2021; no further details provided by the caller. Caller states she was in the emergency room rolled over to the next day on the 09Mar in the evening around 10:30pm and concluded her ER visit on the 10Mar after 12:30. Caller states the HCP gave her the 40mg dose of Prednisone by injection and she has no lot number; states then at the ER, they gave her Prednisone 125mg IV and she has no lot number; they gave her hydroxyzine which is Atarax by IV and gave her Pepcid for her stomach at the same time; no lots for the Pepcid or Hydroxyzine. States the reason for her visit was allergic reaction, allergy hives, post covid delayed reaction. States she let them know at the site that before the vaccine she felt like she might have had an ear infection and was not taking anything no vitamins or anything like that and no Tylenol or anything for a week or so prior because she wanted nothing to be in her system other than the vaccine should anything happen. Had the vaccine that day, later on that afternoon contacted her HCP felt like she had ear infection, no fever but had fullness and some pain in her right ear. Saw her HCP at that time and took a look inside her ear and felt that she did have an ear infection without fever but was painful to the touch around her ear underneath her ear; prescribed Augmentin which she has taken before. Started taking one Augmentin pill on the 23rd in evening which would be Tues 23Feb2021 for the 1st dose, 500mg and dose supposed to take following the next day was to take two tablets one tablet twice per day which she did finish up around 10 days of that on 04Mar. The day before all this started with the rash she finished Augmentin, went to the HCP and two things happened; she was taking Augmentin and had the Pfizer COVID Vaccine. States she had the rash on her elbows and palm and arm and she was like that coincides with the Pfizer vaccine but also was on Augmentin and had been on that before with no problems; thought it was either the vaccine or being on the Augmentin as the reason for the rash but narrowed it to the vaccine. States she ended up in the hospital that evening on Monday evening of 09Mar and it was something they had not seen but were prepared to see could happen and concluded the rash was from the vaccine. Caller states she went to see her immunologist at the conclusion of this event and she was still covered in hives and rash and did step her down on the Prednisone and prescribed her hydroxyzine and topical itch stuff. Caller states she has no lot numbers to provide for the topical stuff or the hydroxyzine or Prednisone. States the HCP concluded she could not receive the 2nd dose of the Pfizer COVID Vaccine or any other vaccine that comes forward and she is not a candidate because of this reaction he can't safely say it would be ok to get a 2nd dose of the vaccine; states she can't receive a 2nd dose of any covid vaccine and it worried her because she has to be ok with having had the 1st dose of the vaccine and wants to know where she stands with that and what to do and she just doesn't know. States it is not she herself saying she can't get the 2nd dose of the covid vaccine but under her HCP advice and two ER visits and many doses of Prednisone and she presented how she looked and that prompted the HCP to say no 2nd dose for her. States she was taking Prednisone started two days of 50mg then 2 days of 40mg, then 30mg, then 20mg, then 10mg and that brought down the amount in her system; states she was given Hydroxyzine 1-2 tablets every 4 hours of 25mg and has no lot numbers for the Prednisone or Hydroxyzine. Caller states instead of taking Benadryl she was taking the topical stuff because Benadryl was not really working and she took Benadryl 25mg tablets in the beginning to try to get the itching out of her system and she felt really really tired and was so tired from taking the Benadryl; caller states she has no lot numbers to provide for the Benadryl. She was given a prescription for Hydroxyzine and the thinks it tended to work better and she did not take a drastic amount of it but it could cause drowsiness and she did feel a lot better from taking it but did not have a really bad feeling of feeling really dopey and sleepy with it because she felt bad enough and did not want to feel bad. States she kept on this for the 10 days or more of a 14 day course and was feeling like until it started to subside. On an unspecified date it was reported that Her WBC count was high and her "liver was not doing great" but recent bloodwork shows it has returned to normal. The patient was hospitalized for the events developed hives/rash on her palms, hands, elbows, and left hip, elbows were red, hive rash on her palm and hand and elbows and it was strange and her elbows were red and were itchy on the palms like red and itchy, her lips and tongue began to swell, WBC count was high, liver was not doing great, post COVID vaccine delayed allergic reaction. The patient underwent lab tests and procedures which included white blood cell count: returned to normal on an unspecified date, white blood cell count: high on Mar2021. Therapeutic measures were taken as a result of the events except for WBC count high and liver was not doing great. The outcome of the events was unknown.
59 2021-04-18 guillain-barre syndrome Gillion bar syndrome, spinal tap confirmed on April 17, 2021 Pain started in her back in April 10th... Read more
Gillion bar syndrome, spinal tap confirmed on April 17, 2021 Pain started in her back in April 10th 36 hours after shot went down her back to but and legs. Friday April 16,2021 she could not walk. Hospital on the 16th by the 17th her arms and hands were affected. Still in the hospital to current date receiving IVIG to see if that will work for her.
59 2021-04-18 lymph node swelling LUMP IN LEFT LYMPH NODE IN MY NECK
59 2021-04-19 lymph node swelling 1)-Pain at injection site for first 5 days; 2)- Periodic reoccurring bouts of nausea accompanied by ... Read more
1)-Pain at injection site for first 5 days; 2)- Periodic reoccurring bouts of nausea accompanied by fever, headache, fatigue,rash that looks like measles on my cheeks and nose, body ache and chills lasting 2-6 hours that began 2 hours after receiving the injection and it has not subsided and it has been 8 days; 3) -Periodic cognitive issues i.e., cant recall words, misplacing items i.e., put food items in cabinet instead of refrigerator, etc; 4)-swollen glands in back and front of neck.
59 2021-04-20 lymph node swelling 2 swollen lymph nodes above collar bone on side of vaccination (right side of 2nd dose). loose mova... Read more
2 swollen lymph nodes above collar bone on side of vaccination (right side of 2nd dose). loose movable nodule about the size of pistachio nut in its shell.
59 2021-04-20 neck mass Left neck adenopathy/mass with pain, limited ability to open the mouth. Solumedrol IM and oral bene... Read more
Left neck adenopathy/mass with pain, limited ability to open the mouth. Solumedrol IM and oral benedryl provided, patient sent to ED for observation, management
59 2021-04-20 swelling face red swollen face and hives on both sides of neck, monitored by facility nurse took benadryl helped t... Read more
red swollen face and hives on both sides of neck, monitored by facility nurse took benadryl helped to calm inflamation 30 minutes later had a rush of heat go thru my body and hives appeared 6 minutes after injection Fever and sore muscles for two days after
59 2021-04-20 swelling 58-year old female presents with 1 day(s) of moderate trauma skin ( bruises, cuts, and scrapes) that... Read more
58-year old female presents with 1 day(s) of moderate trauma skin ( bruises, cuts, and scrapes) that is worsening. Patient has associated edema (and ecchymosis anteromedial right lower leg mid leg to ankle). Patient denies limited range of motion, and fever greater than 100.4. Patient had Pfizer vaccinations finished about 4 weeks ago. Last week carrying package under right arm and developed ecchymosis. Yesterday hit right anterior leg with wet air of pants doing laundry and developed swelling and ecchymosis of left medial anterior leg. States has history of easy bruising. Also is pharmacy tech given COVID-19 vaccinations. Recently stuck finger with clean needle and bleed for quite some time.
59 2021-04-21 lymph node swelling Extreme swell of axillary lymph nodes at the inoculated arm and pain at the site. Other normal kno... Read more
Extreme swell of axillary lymph nodes at the inoculated arm and pain at the site. Other normal known side effects: fever, chills, body aches, headache.
59 2021-04-21 peripheral swelling Very bad headache , dizzy now I am not talking right. Have not feel right since. Arm is still red a... Read more
Very bad headache , dizzy now I am not talking right. Have not feel right since. Arm is still red and swollen
59 2021-04-22 lymph node swelling Upon going to bed, I experienced severe chills and shaking for 5 hours. Also severe headache, jaw, ... Read more
Upon going to bed, I experienced severe chills and shaking for 5 hours. Also severe headache, jaw, body and neck pain. Lymphnodes were swollen. Body aches; fever and nausea and fatigue. This lasted until 8 pm the next day (4/22). I am still experiences chills, fever, nausea, fatigue and general malaise as of 4/23/2021
59 2021-04-23 lymph node pain, lymph node swelling On April 8th my Lymph Nodes in my left arm pit and left side of my stomach started to hurt and swell... Read more
On April 8th my Lymph Nodes in my left arm pit and left side of my stomach started to hurt and swell. I went to the Dr. On 4/14/2021 because pain became worse. On 04/15 I got a rash with severe pain. I went to the ER and was diagnosed with Shingles
59 2021-04-23 swelling face Patient reported adverse effect of covid vaccine dose one during her second dose appointment. Patie... Read more
Patient reported adverse effect of covid vaccine dose one during her second dose appointment. Patient self reported that 12 hours after she received dose 1 of her covid vaccine she woke up with her cheek swollen on her right side. Also part oher her lip and the inside of her ight cheek was swollen. Patient reported she spoke with her oncologist, who recommended she take benadryl. She took Benadryl a few times a day for a couple days, which helped her symptoms. Her symptoms lasted for 1-2 days. Patient reported per d/w her oncologist she took Benadryl as a pre-medication for dose 2 of the covid vaccine.
59 2021-04-24 lymph node swelling SWOLLEN LYMPH NODE NEAR UNDERARM, SOME PAIN-SAME SIDE AS SHOT. (4/21-4/23) LETHARGIC & FEELING ILL, ... Read more
SWOLLEN LYMPH NODE NEAR UNDERARM, SOME PAIN-SAME SIDE AS SHOT. (4/21-4/23) LETHARGIC & FEELING ILL, WEAK, SLOW/DULL BRAIN-EXECUTIVE FUNCTIONING IS LABORED , SOMEWHAT BREATHLESS AFTER SIMPLE ACTIVITY 4/21 AND CONTINUES THROUGH 4/25 (TODAY). TEMP ROLLS FROM 98 TO 99-COMES IN WAVES. LOSS OF APPETITE. VIVID ACTIVE DREAMS. TAKEN SOME ADVIL, TYLENOL PM, BUT NOT CONSISTENTLY.
59 2021-04-24 swelling Right side of face, below jaw at neck swelling and numbness, hives all along neck line, stiffness in... Read more
Right side of face, below jaw at neck swelling and numbness, hives all along neck line, stiffness in face on right side for 24 hours. Pharmacist advised that I purchase Benadryl immediately and then contact my doctor and call 911 if I couldn?t breathe.
59 2021-04-25 lymph node swelling Initially just a sore arm and itching and then each day progressively worse dizziness headache eye p... Read more
Initially just a sore arm and itching and then each day progressively worse dizziness headache eye pain nauseated swollen lymph glands difficulty breathing now 2 weeks!
59 2021-04-25 swelling face mild upper lip and facial swelling over course of one hour; normal vital signs. no progression to a... Read more
mild upper lip and facial swelling over course of one hour; normal vital signs. no progression to anaphylaxis treated with cetirizine 10 mg x 1
59 2021-04-25 white blood cell count increased Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department reporting three weeks... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department reporting three weeks of progressively worse dyspnea on exertion with chest tightness and tachycardia. Initial vital signs within normal ranges. Patient admitted to hospital for observation and testing but left against medical advice before completion.
59 2021-04-26 lymph node swelling Muscle pain & weakness started at bed time on day of vaccination. Woke up next morning still in pain... Read more
Muscle pain & weakness started at bed time on day of vaccination. Woke up next morning still in pain with chills. Slept from noon on 2nd day until 7:00 a.m. the next day, then slept off/on all day & night until the following morning. The muscle pain had mostly subsided when I began to notice more pain in my left shoulder (the injection side) & armpit. My armpit/lymph nodes swelled throughout the day, so I used warm/moist compresses and Tylenol to help alleviate the pain. That was yesterday, and today the area remains painful & I'm continuing my home treatment of compresses & Tylenol.
59 2021-04-26 peripheral swelling Tiredness, headache, muscle pain, chills, fever, stomach pain, redness, pain and swelling in area
59 2021-04-26 peripheral swelling Blood pressure was high, pain in left arm, lump and pain on my left shoulder blade, chills and low ... Read more
Blood pressure was high, pain in left arm, lump and pain on my left shoulder blade, chills and low grade fever. I took Tylenol and the chills and fever went away Friday night, The pain in my arm went away by Sunday, 4/25. My blood pressure went down after drinking more water. I can still feel the lump but its not as painful.
59 2021-04-27 lymph node swelling, axillary mass Sore arm at injection site later in the day and well into the next few days after. Also big lump in... Read more
Sore arm at injection site later in the day and well into the next few days after. Also big lump in armpit (lymphadenopathy) several days after vaccine. Very sore.
59 2021-04-27 lymph node swelling Woke up with a sore-stiff underarm and swollen lymph node. Advised to take tylenol and ice the area... Read more
Woke up with a sore-stiff underarm and swollen lymph node. Advised to take tylenol and ice the area for the next few days. Today is day 3, still a little sore and swollen but it is going down.
59 2021-04-27 lymph node swelling left sided supraclavicular lymphadenopathy
59 2021-04-27 peripheral swelling On 4/20/21 pt says she had swelling in left arm and 101 fever. She started cramping in her right ca... Read more
On 4/20/21 pt says she had swelling in left arm and 101 fever. She started cramping in her right calf. After a week of her leg hurting , on 4/27/21 she went to hospital. She had blood test and doppler. She was diagnosed w/ DVT of lower right extremity. She was prescribed Xarelto and to FU w/ PCP in a week.
59 2021-04-27 swelling face, peripheral swelling Right index, middle and ring finger swelling, abdominal distinction, facial swelling, Left fingers s... Read more
Right index, middle and ring finger swelling, abdominal distinction, facial swelling, Left fingers swelling. Had to take pain relievers to use hands for activities of daily living.
59 2021-04-27 swelling Patient reports receiving 2 Pfizer COVID vaccines. The first one was on 3/17/21 with lot # EN6207 wi... Read more
Patient reports receiving 2 Pfizer COVID vaccines. The first one was on 3/17/21 with lot # EN6207 with no adverse reactions. She received her second one on 4/5/21 with lot #EP7533. She reports she started "feeling bad" 4/6/21-4/11/21. She noticed left sided neck swelling on 4/11/21. She went to urgent care and was seen by an NP and was told to go to for a CT scan the next day since it was on a Sunday. Patient reports she went home and had further left sided neck swelling and difficulty breathing. She "couldn't catch her breath". EMS was called and she was transported per her request to Hospital. She had a 9 day hospital stay and was told she was having a severe reaction to the vaccine and that she had pneumonia with fluid in her lungs and fluid around her heart. She was treated with 2 antibiotics, IV fluids, and a diuretic. Patient had a follow up with her primary care on Monday 4/26/21 with NP and was told her heart and lungs sounded clear. She has a follow up appt scheduled with her lung doctor Dr on 5/24/21. Patient did not say why she has seen a lung doctor before but that she had been seeing this doctor prior to this adverse reaction. She was told in the hospital that it was not normal to be having this much swelling. Patient states she still feels weak and is still somewhat short of breath.
59 2021-04-28 peripheral swelling Swelling tongue, throat, ankles, hands, headache, stuffed nose
59 2021-04-28 peripheral swelling a few hours later she was fatigue, the next day there was sore muscles and the arm was sore, the sor... Read more
a few hours later she was fatigue, the next day there was sore muscles and the arm was sore, the soreness of muscles were gone but the arm was more swollen. There is no pain unless pressing directly on it but there is swelling.
59 2021-04-29 peripheral swelling Limb swelling, left ankle, hard in center, slightly tender
59 2021-04-29 swelling Just under 48 hours after the vaccine on 4/10/2021, I experienced a large swelling on either side of... Read more
Just under 48 hours after the vaccine on 4/10/2021, I experienced a large swelling on either side of my neck, up and down the neck. I assume it was my lymph nodes. I felt as if someone was pushing my Adam's apple. Unpleasant and scary as I though it might get worse and I would choke. This lasted most of the day Saturday. The same swelling and pressure in my throat occurred after the second Pfizer shot on 4/29/2021 (Lot Number: EW0153 ; 7/21/2021). This time it happened more quickly. Five hours after I received the shot. (Vaccine received at 11:30 am). The pressure in my throat lasted throughout the afternoon. I also felt burning and tingling at the site of the FIRST vaccine at this time.
59 2021-04-30 lymph node pain acute lymphatic response/severe pain in lymph nodes, the ones around her ovaries/severe pain like cy... Read more
acute lymphatic response/severe pain in lymph nodes, the ones around her ovaries/severe pain like cysts except both sides were hurting; had trouble catching breath with the pain; arm pain; brain fog/head started feeling foggy and weird; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 16:00 (Lot Number: EN5318, Expiry date: 31May2021) on left arm at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. Historical Vaccine included flu shots. The patient stated her physician told her she had an acute lymphatic response. She added there was something about 3 am (18Mar2021) because she woke up at 3 am and had severe pain in some of her lymph nodes. In particular, the ones around her ovaries. She added that she was old and her ovaries had not worked in a long time. She had severe pain like cysts except both sides were hurting. She also had trouble catching breath with the pain. This lasted 45 minutes and subsided. The next morning 18Mar2021, when she got up some of her lymph nodes were very panful and there was one even that was a node visible down her throat almost at the base of her neck in the center. She could see it sticking out, it was crazy. It went down in about three days. The pain and the weirdness in all of her other lymph's was about 3 or 4 days. It was an odd response and people told her it was just her body acting like a young person and was going to work. This was the first issue she had with the vaccines. The patient also experienced brain fog after first vaccine on 17Mar2021: within 2 or 3 minutes of having them her head started feeling foggy and weird. It was after the first vaccine, she thought it was psychological but it did not go away and it was not psychological. It was like a weird foggy and like taking sinus medication, no additional details. When it happened with the first vaccine, it did not concern her as much as the first one. It went away after the first vaccine probably late that evening (17Mar2021), around 10:30 pm right when her arm started to hurt. She did not have arm pain that was severe. She added maybe it lasted a day. The next day it hurt but it was not anything bad, it just hurt to touch it and to lift it hurt for a day. Maybe this was for 36-40 hours before the pain went out. The outcome of event "trouble catching breath with the pain" was resolved on 18Mar2021 03:45, outcome of event "brain fog/head started feeling foggy and weird" was resolved on 17Mar2021, outcome of other events were resolved in Mar2021. No follow-up attempts are needed. No further information is expected.
59 2021-04-30 peripheral swelling they did an ekg and it was abnormal, I have 2 extra heartbeats; having a hard time walking moving he... Read more
they did an ekg and it was abnormal, I have 2 extra heartbeats; having a hard time walking moving her muscles; having a hard time walking moving my muscles/Every muscle and joint ached severely; having a hard time walking moving my muscles/Every muscle and joint ached severely; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; I have had fluttering and my heart feels like it is jumping in my chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 08:45 at single dose in left arm for COVID-19 immunisation. Medical history included Hypothyroidism, fibromyalgia, Type 2 diabetes. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medications included atorvastatin, duloxetine, glimepiride, and levothyroxine. The patient had not received other vaccine in four weeks. The patient previously received pregabalin (LYRICA) and had allergies. On 02Apr2021 12:00, the patient had Redness and swelling in left arm for 2 days with pain. 2 days after shot (04Apr2021) she was having a hard time walking moving her muscles. Every muscle and joint ached severely nothing helped the pain. Now she was 13 days past the shot with muscle pain. She went to doctor yesterday (14Apr2021) and they did an EKG and it was abnormal. She had 2 extra heartbeats in Apr2021. Since shot she had had fluttering and her heart felt like it was jumping in her chest. The patient had Blood work in Apr2021. The outcome of all events was not resolved. Information on the lot/batch number has been requested.
59 2021-04-30 swelling swelling all on the site; a little bit of soreness/her arm was sore; This is a spontaneous report fr... Read more
swelling all on the site; a little bit of soreness/her arm was sore; This is a spontaneous report from a contactable consumer or other non-health care professional. A 60-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8727) via an unspecified route of administration in right upper arm on 18Mar2021 around 15:00 PM as single dose for COVID-19 immunization (at 59 years old). Patient received the second dose of (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration in right upper arm on 08Apr2021 as single dose for COVID-19 immunization. Medical history included ongoing COPD; Unsure of diagnosis date but it was maybe 10 years ago, ongoing Chronic kidney disease stage 3; Unsure of diagnosis date but probably more than 20 years ago and it is stable. They check it every 3 months and it is stable. Historical vaccine included flu shots and pneumonia shots; she has had flu shots and pneumonia shots and has never had any reaction to anything before. Patient mentioned that she is on medication (unspecified) but she has been on them all her life there is just about nothing new that was taken at all. On 18Mar2021, patient experienced swelling all on the site and a little bit of soreness/her arm was sore. Outcome of the events was recovered on 19Mar2021. Follow-up (20Apr2021): This is a follow up spontaneous report received from a contactable consumer reported that no new AE was reported. No follow-up attempts are needed. No further information is expected.
59 2021-05-01 lymph node swelling swollen lymph nodes under arm, headache
59 2021-05-02 swelling Lesions over body. Started as small bumps then grew into large patches ones hands, arms and legs. Al... Read more
Lesions over body. Started as small bumps then grew into large patches ones hands, arms and legs. All areas infected have swollen. Can not make fist with right hand
59 2021-05-03 swelling Throat closed up when I woke up the next morning. Same symptoms as previous angioedema episodes.
59 2021-05-04 lymph node swelling patient experienced reaction after covid shot. had a swollen lymph node on bottom front of neck. Had... Read more
patient experienced reaction after covid shot. had a swollen lymph node on bottom front of neck. Had rash on right arm (just below site of administration) which patient characterized as red and about the size of 2 quarters (currency) and was not itchy. occurred a few days following vaccine and has nearly dissipated. patient requested rph file report.
59 2021-05-04 swelling face Patient received vaccine on Saturday and on Sunday she said that she developed itching all over and ... Read more
Patient received vaccine on Saturday and on Sunday she said that she developed itching all over and the left side of her face swelled slightly.
59 2021-05-05 anaphylactic reaction Reaction: Anaphylaxis, numbness in the nose area and heaviness in the chest Severity: High
59 2021-05-05 swelling face Got light headed 12-14 minutes after shot, at 30 minutes in car took off mask had red fire engine ra... Read more
Got light headed 12-14 minutes after shot, at 30 minutes in car took off mask had red fire engine rash on cheeks/chin and face swelling, roof of mouth felt slightly swollen and lips tingly feeling slightly swollen, pills felt stuck in back of throat. went back in facility they told me to take Benadryl and go to doctor or ER if it gets worse, took Benadryl and Zyrtec and started past allergic reactions protocol, up to 4 Zyrtec and 4 Allegra in a day and Benadryl as needed. QNasl. Saw nurse practitioner who added Pepcid 2times a day. Did this for 3 weeks pills still feel stuck at back of throat on and off in a day.
59 2021-05-09 lymph node swelling Very swollen lymph node near my left ear and jaw
59 2021-05-10 oral herpes, lymph node swelling fever blister; swollen lymph nodes; injection site soreness; This is a spontaneous report from a con... Read more
fever blister; swollen lymph nodes; injection site soreness; This is a spontaneous report from a contactable consumer (patient, self-reported). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Apr2021 as SINGLE DOSE for covid-19 immunization. Medical history included covid-19 on an unknown date. The patient's concomitant medications were not reported. Approximately on unspecified date in Apr2021 (After receiving the vaccine), the patient experienced a fever blister, swollen lymph nodes and injection site soreness. Caller stated that she called to report these symptoms and stated: "I've had covid before and want to take every precaution possible". Should she get the second dose of the vaccine. The clinical outcome of the events was unknown. No PQC involved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
59 2021-05-10 swelling Mouth broke out; zit that broke out on the top of her eyebrow. There are hard little bumps; they wer... Read more
Mouth broke out; zit that broke out on the top of her eyebrow. There are hard little bumps; they were red and hard; Arm was sore; puffy/swollen; She had a breakout on her face, a couple of lesions, and her mouth broke out.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included allergic to Penicillin, crustaceans, shellfish, and mushrooms. Those were what she usually had a breakout for. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced drug allergy and second degree burns. Her reaction to amoxicillin was probably 15 years before. The patient had a reaction to her first Covid-19 shot. She took the first shot last Tuesday. She had a breakout on her face, a couple of lesions, and her mouth broke out. It looked like a reaction. She took a couple of diphenhydramine hydrochloride (BENADRYL), and it was going away. Her second shot was scheduled for next Tuesday 11May2021. She needed to know if there was anything in the shot that would cause this. She was leery of taking it. She was okay with it, and the diphenhydramine hydrochloride was fine. She did contact her doctor. That was it, she had nothing else just the breakout. She thought it was maybe Thursday 22Apr2021 or Friday 23Apr2021 that she noticed the breakout on her face. She started trying to take some diphenhydramine hydrochloride. It was rapid when it happened, not slow. She saw these as almost like a reaction. She had welting on the skin similar to a reaction to dust mites. There was this thing she thought was just a zit that broke out on the top of her eyebrow. There were hard little bumps. One had gone away, and the other was still there. It was almost like when she had a breakout of zits was kind of what she would say. It was dissipating. She started taking rounds of diphenhydramine hydrochloride to stop the reaction, and it was working. She was concerned about the second shot. She didn't know if it was an allergic reaction to amoxicillin or any other type of medicine if it was in there. That was what she was concerned about. Before she got the second shot she needed an idea of what might have happened. The lesions came a day or so after the breakout on her face. She would say Sunday 25Apr2021 was when she saw the lesions above her eyebrows. It was right at the beginning of her eyebrow. It was really hard at first. It was not itching, just like zits. Similarly, they were red and hard. Once again she started the diphenhydramine hydrochloride and saw a little bit of difference, but had to keep putting on topical Aquaphor and cocoa butter. She had to keep putting it on there, it was just swollen. The lesions were puffy and red. There was just one left, it was going down. Her mouth was the number one thing. She thought it was from wearing a mask. She had never had a breakout with a mask before. She took the shot on Tuesday, and her arm was sore just for 24 hours. She noticed her mouth broke out Thursday or Friday for sure when she woke up. At first she just kind of forgot about the shot and didn't put two and two together. She took diphenhydramine hydrochloride. It was the same type of reaction she would have if it was amoxicillin. She really needed to know if she should anticipate something with the second shot. Outcome of event a breakout on her face, a couple of lesions, and her mouth broke out was resolving, and of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
59 2021-05-10 systemic inflammatory response syndrome R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ... Read more
R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction E87.1 - Hypo-osmolality and hyponatremia
59 2021-05-11 lymph node swelling painful adenopathy and swelling of left axilla started about 2 days after the patients 2nd Pfizer va... Read more
painful adenopathy and swelling of left axilla started about 2 days after the patients 2nd Pfizer vaccine (left arm)
59 2021-05-11 peripheral swelling, swelling face Chills, shakes, fever over 102, severe joint pain and muscle pain, swelling in hands and face, nause... Read more
Chills, shakes, fever over 102, severe joint pain and muscle pain, swelling in hands and face, nausea, arm swollen to size of softball, feeling like the worse case of a bug I have ever had.
59 2021-05-11 swelling Patient presented with complaints of itching, hives and swelling around areas of hives. Hives noted ... Read more
Patient presented with complaints of itching, hives and swelling around areas of hives. Hives noted on arms, legs and back
59 2021-05-12 swelling face Swelling of the face, fast heartbeat, dizziness weakness tiredness terrible headache muscle pain chi... Read more
Swelling of the face, fast heartbeat, dizziness weakness tiredness terrible headache muscle pain chills sweated at night swollen site injection nauseated feeling unwell diarrhea arm pain extreme feeling very very weak .
59 2021-05-13 fluid retention Worsening HTN w/ fluid retention and blurry vision
59 2021-05-13 lymph node swelling, swelling Per patient's physician: Supraventricular Lymphadenopathy. Patient states her neck (clavicle) in ve... Read more
Per patient's physician: Supraventricular Lymphadenopathy. Patient states her neck (clavicle) in very swollen and painful (size of golf ball). Should resolve itself in approximately 2 weeks.
59 2021-05-17 lymph node swelling Swollen lymph nodes under arm (armpit).
59 2021-05-18 guillain-barre syndrome AIDP (Acute Inflammatory Demyelinating Polyradiculopathy); This is a spontaneous report from a conta... Read more
AIDP (Acute Inflammatory Demyelinating Polyradiculopathy); This is a spontaneous report from a contactable Physician. A 59-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) vaccination at the age of 59 years old as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included bunion surgery between CCPD and vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had acute onset peripheral and central demyelination as confirmed on MRI (magnetic resonance imaging) brain and spine with and without contrast. AIDP (Acute Inflammatory Demyelinating Polyradiculopathy) confirmed with two NCC/EMG (NCC Electromyography). Patient presented with lower extremity weakness, upper and lower motor neuron signs, somnolence, upper extremity dysmetria, and right lower facial droop. This occurred 22 days after first vaccine. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment received for the adverse event included PLEX (Plasmapheresis) x 5 treatments, and methylprednisone x 5 days followed by prednisone taper. The outcome was recovering. Information of the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the event AIDP (Acute Inflammatory Demyelinating Polyradiculopathy) cannot be excluded completely. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
59 2021-05-19 peripheral swelling When I got the vaccine I had a metallic taste. I waited the 15 minutes and no problem. I went to wor... Read more
When I got the vaccine I had a metallic taste. I waited the 15 minutes and no problem. I went to work and after some minutes I had swelling in my throat and arm and I went to the ER. My airway was not fully shut but they gave me steroids and other stuff and then I was fine. I waited about 2 hours and I was fine later.
59 2021-05-21 lymph node swelling knot above her shoulder blade on her collar bone; swollen gland around her left collarbone; back spa... Read more
knot above her shoulder blade on her collar bone; swollen gland around her left collarbone; back spasms; nausea; sore arm in her left arm which was the injection arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 17Apr2021 (Batch/Lot Number: ER8733; Expiration Date: Jul2021) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included nifedipine (NIFEDIPINE) taken for blood pressure increased from Feb2021 and ongoing; betacarotene, bioflavonoids nos, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (MULTIVITAMIN & MINERAL) taken for immune system disorder from 2020 and ongoing; 1-alpha-hydroxyvitamin d3 (1-ALPHA-HYDROXYVITAMIN D3) taken for immune system disorder, bone disorder from 2020 and ongoing. The patient stated she received her first Pfizer Covid vaccine dose on 17Apr2021. That same day she started to experience nausea which resolved. She also experienced a sore arm (injection arm was left arm) for a few days, which has resolved. She reported back spasms on 26Apr2021 which have since resolved. She stated she began to have a swollen gland around her left collarbone on 27Apr2021 which continues to be swollen. Around 5-6 days after, she experienced a knot above her shoulder blade, on her collar bone. She went to get her 2nd shot today, and told them about the knot, it does not hurt, and they advised she go see a doctor. The outcome of the event knot above her shoulder blade on her collar bone was unknown, event swollen gland around her left collarbone was not recovered while other events were recovered on an unspecified date.
59 2021-05-22 lymph node swelling about 3 days after receiving the vaccination for covid, I developed a rash under my right arm pit I... Read more
about 3 days after receiving the vaccination for covid, I developed a rash under my right arm pit I bought Lotrimin lotion and spray and treated myself for 10 days. I also have swollen Lymph nodes under left chin between my jaw and my ear.
59 2021-05-25 swollen extremities Headaches (mild), increase in fasting glucose 30% from 124 to 155 or more, fatigue, weight gain 5lbs... Read more
Headaches (mild), increase in fasting glucose 30% from 124 to 155 or more, fatigue, weight gain 5lbs or more, edema of the feet and hands (mild).
59 2021-05-25 swelling Within 2 minutes and her heart rate was over 112 beats per minute. Alsolso felt dizziness, lighthead... Read more
Within 2 minutes and her heart rate was over 112 beats per minute. Alsolso felt dizziness, lightheaded, vertigo, brain fog, tinnitus, rash on upper back, puffy red lips, white spots on the soles of the feet, stomach cramps, had problems forming sentences,had a hard tine even trying to call husband, itchy eyes, felt itchy and hot on her injection arm, had difficulty breathing, had to to take deep breaths, chills, freezing, headache, tongue started to swell, neck started to swell in the thyroid area, started to feel tired and sleepy, had to get assisted to the bathroom, the walls started to move in. The patient took Claritin 1 hour and a half i because they didn't want to give her her epi pen because her heart rate was too high and she is allergic to Benadryl. Stayed at the site for 2 hours, drank a lot of water, couldn't walk and she had to stay in a wheelchair. She said it took around 2 weeks to feel normal. She had spells of feeling dizzy and confused with brain fog for 2 weeks. Felt tinnitus for around 10 days after the vaccine. tinitis lasted 10 days brain fog 2 weeks: didn't know how to figure out how to turn car on. fatigue lasted about 4 weeks white spot on feet went away 2 weeks.
59 2021-05-25 swelling Muscle soreness; High fever; Coughing; Chills; Sore throat; lump and swelling...above her collarbone... Read more
Muscle soreness; High fever; Coughing; Chills; Sore throat; lump and swelling...above her collarbone; lump and swelling...above her collarbone; This is spontaneous report from a contactable consumer (patient). A 59-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date as a single dose for COVID-19. The patient received dose 2 of the vaccine on Tuesday morning. She felt fine at first but that evening she had muscle soreness. On Wednesday she had a high fever, coughing, chills, and sore throat. The fever went away that evening. "Yesterday" (23Apr2021) between 16:00-17:00 the patient noticed where the seatbelt goes a lump and swelling on the same side the vaccine was injected above her collarbone. The patient had an appointment with a dermatologist but if her symptoms resolved before the appointment she would cancel it. The outcome of fever was recovered. The outcomes of muscle soreness, coughing, chills, sore throat, lump, and swelling were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained
59 2021-05-28 peripheral swelling, swelling Rigger, redness and swollen neck hands and feet, rashes neck feet abdomen
59 2021-05-28 peripheral swelling The day after my second injection I began to feel Painful Numbness & Tingling in my hands/arms and m... Read more
The day after my second injection I began to feel Painful Numbness & Tingling in my hands/arms and my legs and feet. Swelling of my legs & feet, socks leaving big indents in my skin. Off and on headaches, an intense itch at times, all over, blisters on my butt(2) that "popped" and left the skin open and raw. I also just feel "off", do not feel like myself, a little bit unsure about my footing...
59 2021-05-28 swelling face Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of ... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
59 2021-06-01 c-reactive protein increased 5/16/21 Pt presented to a free standing ED with complaints of cough, body aches, nasal congestion an... Read more
5/16/21 Pt presented to a free standing ED with complaints of cough, body aches, nasal congestion and otalgia that started around 5/11/21. In the ED she had audible wheezing, mild tachypnea (RR19) and her RA pulse ox was 88-943%. She was placed on oxygen and found to be positive for SARS-CoV-2. CXR showed possible pneumonia and she was transferred to a tertiary care facility for admission. She was discharged on 5/21/21 Acute hypoxic respiratory failure, resolved Covid-19 Virus Infection Date of onset of symptoms: Approximately 7 days prior (5/15/2021) Symptoms present on admission: Nasal congestion, myalgias, productive cough of yellow-green sputum, diarrhea Date of covid positive test: 5/16 Vaccination status: vaccinated, received only first dose Imaging: CXR with lobar pneumonia Oxygen requirements on admission: 2 L Current oxygen requirements: None Medical therapy: Oral prednisone, not a candidate for remdesivir Inflammatory markers: CRP 18.1, ferritin 111, D-dimer 0.62, LDH 174 Community-acquired pneumonia Given lobar appearance on CXR and productive cough of green/yellow sputum I do feel it prudent to cover the patient for community-acquired pneumonia Treated with Azithromycin, Augmentin Acute on chronic kidney disease Baseline serum creatinine approximately 1.1-1.2, presenting serum creatinine 1.94 Prerenal versus intrinsic renal 2/2 infection Creatinine trending down to 1.24 at time of discharge COPD with acute exacerbation IV Solu-Medrol initially, transition to oral prednisone Schedule bronchodilators Started Symbicort per hospital formulary, and held home Flovent while hospitalized Antibiotic coverage as above
59 2021-06-01 lymph node swelling 3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with l... Read more
3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with lumps under my skin and felt hot.; 3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with lumps under my skin and felt hot.; Could not lift my arm and the pain was like an 8 of 10.; 3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with lumps under my skin and felt hot.; Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non stop until 6pm that evening.; Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non stop until 6pm that evening.; Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non stop until 6pm that evening.; Also my left arm hurt so bad for 3 days; with lumps under her skin; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EWO179) via an unspecified route of administration on left arm on 03May2021 11:30 as 2nd dose, single for covid-19 immunization. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EWO158) via an unspecified route of administration on left arm on 12Apr2021 at 10:30 as 1ST DOSE, SINGLE for COVID-19 immunisation. Known allergies were none. Medical history and concomitant medications were not reported. She did not take any other vaccine in four weeks and no other medications within two weeks. On 06May2021 at 20:30 3 days & 9 hours after 2nd vaccine patient reported that she broke out in a rash on her chest neck and behind her ears, with lumps under her skin and felt hot. Took Benadryl at 21:00, in morning rash moved to stomach and left side. Event resulted in Doctor or other healthcare professional office/clinic visit. Then took Claritin and it disappeared. Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non-stop until 18:00 that evening. Also, her left arm hurted so bad for 3 days that she took Tylenol on day 2 after vaccine. Could not lift her arm and the pain assessment was like an 8 of 10 on 06MAY2021. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. The clinical outcome of all events was resolved on an unspecified date of 2021. No follow-up attempts are possible. No further information is expected.
59 2021-06-06 c-reactive protein increased Three days after receiving the first dose, I woke to significant joint pain and stiffness. It was e... Read more
Three days after receiving the first dose, I woke to significant joint pain and stiffness. It was extrmely difficult to move around as well as ascend and descend stairs and transition from sit <->stand without great effort. Pain and discomfort was so high that I often felt extreme fatigue going up/down 1 flight of stairs. These adverse events lasted for at least 3 weeks post my second vaccination. 4/3/21 PCP visit for knee pain (R>L) xrays taken referred to Sports Medicine 3/9/2021 visit to Sports Medicine more xrays and ultrasound referred to Rheumatology 4/9/2021 Rheumatology full exam (to rule out rheumatoid arthritis(?) then additional bloodwork) 5/3/2021 Gastronterology appointment (in flare) prescribed steriod and suppository 5/28/2021 Emergency Department visit per direction of GI's office prescribed tapered course of steriods (Prednisone) and antibiotic (Flagyl)
59 2021-06-06 lymph node swelling She stated that after her second dose she developed a swollen lymph node under her armpit of the arm... Read more
She stated that after her second dose she developed a swollen lymph node under her armpit of the arm she got the vaccine in. I explained to her that this is a normal thing and is a known side effect, however she then stated that she now has a raw, red, open skin rash under her armpit on in the same spot the swollen lymph node was. She stated she has been dealing with this for weeks and that it is not responding to any treatment. The patient stated she has not been to her Dr. yet because she hasn't had time, but this has been going on for weeks since her second dose.
59 2021-06-07 swelling face, swelling couldn't read or write; couldn't read or write; inflammation in the tongue; cannot turn from her nec... Read more
couldn't read or write; couldn't read or write; inflammation in the tongue; cannot turn from her neck because it was swollen; couldn't sleep and toss and turn; Sweating; sharp pain in her head; pain from her neck; sharp pain coming from her ear; feeling the pain/feeling the pain when laying down and she cannot handle the pain; It hurt, even when eating her throat hurt and it hurt to swallow and pass food; gaining weight; cheek and tongue swollen, it was swollen; cheek and tongue swollen, it was swollen; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Jan2021 (at age of 59-year-old) as single dose for covid-19 immunisation. Medical history included ongoing human immunodeficiency virus (HIV). The patient's concomitant medications were not reported. Patient received the first dose of Covid vaccine on 28Jan2021. Patient had inflammation in the tongue and she cannot turn from her neck because it was swollen. It was been 3 months since she received the vaccine (Apr2021). She went to the emergency room and also to her primary care provider and they just cannot find anything. She has had it, the vaccine, and it was good and she had good health when she got the first dose. Mentioned she couldn't read or write. On unspecified date in 2021, she would like to file a safety report because at night she couldn't sleep and it felt like a sharp pain in her head and she started sweating. Feels the pain from her neck and sharp pain coming from her ear. She couldn't sleep and toss and turn. Told the doctor and was informed to buy pills to sleep and even with the pills the pain still wakes her up. Clarified pills as Melatonin. Mentioned she had called before to this number (Pfizer), but they just do not answer. Has tried this number a couple days ago. Had not spoken to safety. Wanted to know what to do because she was feeling the pain. What was she going to do during the day when feeling the pain when laying down and she cannot handle the pain. She went 3 times to the emergency room and 3 times to the primary care provider and they cannot recommend anything because this was from the shot she was given. Wanted to know if the doctor couldn't give her any medicine, why did they give vaccine to her. Said if she took this to the tv or media and said she got the vaccine and it was not working and cannot get any good advice for a doctor what was she to do. Not sure if it was because she does not understand because she does not read or write. Has been gaining weight even though she did not eat. The inflammation of the tongue was noticed since the first vaccine. She had called the doctor and he told her to take allergy pills. So she went to the pharmacy, got it and nothing it did help her. She still felt like that with the cheek and tongue swollen, it was swollen. Clarifies pilled as Benadryl. Issues, pain with neck have all been since the first vaccine and it got worse after the second dose. It hurt, even when eating her throat hurt and it hurt to swallow and pass food. Went to the emergency room 15 days after the second dose because she could not handle the pain. The sharp pains, sweating, pain in ear came and gone and really felt it when laying down she felt the sharp pain in the head. Had to be upside down in order to feel better. The pain waked her up from sleep. No other vaccines given the same day and no problems with vaccines in past. At clinic there were tests ordered and exams, x-ray for the neck and on Tuesday they took 5 bottles of blood to see what the labs look like. When she was at the emergency room, they took x-rays and the doctor ordered those exams and all came out fine. They gave her the shot (covid) so soon because she has HIV. She was perfectly fine for 19 years and was fine with all her medicines and treatments. All exams came out fine and everything. Clarified HIV (human immunodeficiency virus) diagnosed and treatment/medications were before she received the Covid vaccines. The outcome of the events "feeling the pain/feeling the pain when laying down and she cannot handle the pain", "gaining weight", "cheek and tongue swollen, it was swollen" was unknown, for other events was not recovered. Information about lot/batch number has been requested.
59 2021-06-08 peripheral swelling This is a spontaneous report form the contactable consumer (patient). A 59-year-old female patient r... Read more
This is a spontaneous report form the contactable consumer (patient). A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL3247, NDC number and Expiry Date: Unknown) via an unspecified route of administration in left arm on 16Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included autoimmune disorder (diagnosed 35 years ago) and has not been experiencing any symptoms from that just some very minor symptoms very recently. Concomitant medication was not reported. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Patient had previously received first dose of vaccine (Lot no: EP7534) on 26Mar2021 and had left arm swelling (injection arm) and pain, along with migraines and fatigue which resolved after a week. Immediately the same day as the 2nd dose of the vaccine, the patient had pain in her left (injection) arm/hurting and restricted movement in her left arm. On an unspecified date (after the second dose), patient was extremely tired, very fatigued and had migraines along with pain and swelling in her left (injection) arm. The pain in her arm continued for about 6 weeks. Patient did not remember what got better and what got worse and forgot about it, but the pain never went away. The swelling got better but was not as bad. No treatment was received for the events. Events did not require visit to emergency room or physician office. The outcome of events pain in her left (injection) arm was swelling and hurting and restricted movement in this arm was not resolved while for other events fatigue and migraine was unknown. Additional information has been requested.; Sender's Comments: Agent, caller is a consumer that reported her side effects after receipt of both doses of Pfizer COVID vaccine, however her question is if she can get further clarification if possible, regarding if she should go have quantitative antibody testing that will tell her if she is protected or not? caller was warm transferred by Agent and caller stated "I got information that I did not understand", caller asked: "How do I know if my second dose worked if I had this side effects?. E-transmitted duplicate AE, caller did not provide additional AE details Response: Responded per documents attached and referred for discussion. Offered to send PRD by email, but caller declined and stated her HCP will have that information. Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller stated from prior INT: "I got information that I did not understand" Caller stated she also did not understand information provided by Agent during this follow-up INT. Response: Referred back to her HCP for specific recommendations and medical advice regarding antibody testing, and offered to email the PRD from response provided in prior Request and Interaction, but caller declined and stated her HCP will have that information.
59 2021-06-08 swelling She already took Tylenol yesterday because of headache and high hernia and high hernia is swelling; ... Read more
She already took Tylenol yesterday because of headache and high hernia and high hernia is swelling; I got headache; I have a higher hernia and after the Tylenol it made my high hernia to swell, it made my stomach open up and I got sick; stomach open up; I got sick; high hernia is swelling; This is a spontaneous report from a Pfizer sponsored program via contactable consumer (patient, self-reported). A 59-year-old female patient (age at vaccination: 59 year) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 02Jun2021 at 13:05 PM, as a single dose for COVID-19 immunization; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; ibuprofen (IBUPROFEN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she already took Tylenol (Captured as suspect) yesterday because of headache and high hernia and high hernia was swelling; she got headache. She had a higher hernia and after the Tylenol it made her high hernia to swell, it made her stomach open up and she got sick on 02Jun2021. The patient stated, she wanted to find out if it was okay for her to take the Ibuprofen (captured as suspect) because she was told that we are taking the shot, she already had her second shot, this was her second, she had it was second, but they told her to take Tylenol and she had a higher hernia and after the Tylenol it made her high hernia to swell, it made her stomach open up and she got sick. She got headache like so and all and she mean she just, she was for bed off. So, she wanted to find out if it was okay to take as Ibuprofen and two doses of the Tylenol. The action taken in response to the events for Tylenol and Ibuprofen was unknown. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
59 2021-06-09 lymph node swelling Lymph Node swelling under armpit - same arm as injection, this began 2 days after the injection and ... Read more
Lymph Node swelling under armpit - same arm as injection, this began 2 days after the injection and has persisted.; This is a spontaneous report from a contactable non-health care professional. A 59-year-old non-pregnant female patient received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration, on left arm on 12Mar2021 at 11:00 (at the age of 59-years-old) as single dose for COVID-19 immunisation. Medical history included hyper tension, occasional migraines, depression. Concomitant medications included MD-cholesterol( MANUFACTURER UNKNOWN) ,curcumin( MANUFACTURER UNKNOWN), fluoxetine(PROZAC) , tekturna( MANUFACTURER UNKNOWN), amlodipine besylate( MANUFACTURER UNKNOWN), baby aspirin (MANUFACTURER UNKNOWN), losartan-hctz 100 ( MANUFACTURER UNKNOWN), magnesium ( MANUFACTURER UNKNOWN)and tylenol (MANUFACTURER UNKNOWN) . The patient had not received any other vaccines within four weeks prior to the COVID vaccine and was not been diagnosed with COVID-19. Patient experienced Lymph Node swelling under armpit - same arm as injection on 14Mar2021 at 13:00. The patient did not receive any treatment for reported events. The clinical outcome of event Lymph Node swelling was not recovered. No follow-up attempts are needed. No further information is expected.
59 2021-06-10 swelling Pain, warmth, swelling for > 2 weeks. Peeling skin, loss of pigmentation of skin
59 2021-06-10 swelling urticaria, swelling L axilla, unusual odor to urine. symptoms persist 6/11/2021
59 2021-06-12 lymph node swelling swollen lymph node left axilla
59 2021-06-16 lymph node swelling Muscle pain; Low grade fever; Fatigue; headache; swollen lymph nodes; Hives; This is a spontaneous r... Read more
Muscle pain; Low grade fever; Fatigue; headache; swollen lymph nodes; Hives; This is a spontaneous report received from a contactable other healthcare professional, the patient. A 59-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in her left arm on 26Feb2021 at 9:45AM (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient medical history included hypothyroidism. The patient past drug history included received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9810) via an unspecified route of administration in her left arm on 04Feb2021 at 9:30 AM as a single dose for COVID-19 immunisation. The patient has allergies to medication and food sensitivities, seasonal allergies, pollen, dust mold. The patient was diagnosed with COVID-19 prior to vaccination. The patient has not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since having the vaccine, the patient was not tested positive for COVID-19. The patient concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) cataplex C (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), Vit-D (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN) within two weeks of COVID-19 vaccination. On 27Feb2021, the patient experienced low grade fever, fatigue, pain joints/muscles, headache, swollen lymph nodes. head to toes hives. The therapeutic measures taken included benadryl (MANUFACTURER UNKNOWN) on an unknown dose after calling a doctor. But it was stopped due to an unknown side effect. Started Antronex which was further mentioned as tolerable during day but not at night. It was also mentioned that the same medicine was continued week three with no relief and later began 10 day/5 mg Prednisone (MANUFACTURER UNKNOWN) on 18Mar2021. The clinical outcome of events low grade fever, fatigue, headache, swollen lymph nodes were resolved and hives was not resolved at the time of the report. No follow-up attempts are needed. No further information is expected.
59 2021-06-16 lymph node swelling Pain in left breast near armpit; Suspect swollen lymph nodes; This is a spontaneous report received ... Read more
Pain in left breast near armpit; Suspect swollen lymph nodes; This is a spontaneous report received from a contactable consumer. An 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206, Dose number: 2) via unknown route of administration on the left arm on 16Mar2021 at 11:15 hours as a single first dose for COVID-19 immunisation. The patient's past drug history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW6198) via an unspecified route of administration on 24Feb2021 at 15:15 hours as single first dose for COVID-19 immunisation. Medical history included arthritis. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ZYRTEC, Rousuvastatin (MANUFACTURER UNKNOWN), Vitamin D (MANUFACTURER UNKNOWN), XHANCE for an unknown indication since an unspecified date and was unknown if ongoing. On 17Mar2021 at 7:00 hours, the patient experienced pain in left breast near armpit. The pain was still present 2 days after the vaccine. The patient suspected it was swollen lymph nodes but the patient was concerned about another cause and was concerned it would persist. The clinical outcome of the events pain in left breast near armpit and suspect swollen lymph nodes was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.
59 2021-06-16 swollen extremities Pain in left thigh/pain in her arm; Swelling in left thigh; Extensive bruising on left thigh; Extens... Read more
Pain in left thigh/pain in her arm; Swelling in left thigh; Extensive bruising on left thigh; Extensive bruising and swelling in her left thigh/ pain in left thigh was reported as worsened; Nausea; This is a spontaneous report from a contactable consumer. A 59-years-old female patient (age at time of onset of reaction) reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration in left arm on 26May2021 at 14:30 as a 1st dose, single dose for covid-19 immunization. Medical history included COPD, allergies to flu and pneumonia vaccines, she had cancer twice, also had cancer on scalp and developed pneumonia and partial lung removed all from an unknown date and unknown if ongoing. The patient stated that she was cancer free and didn't had chemo over a year. The patient did not receive any previous immunization with the Pfizer vaccine considered as suspect or additional vaccines administered on same date of the Pfizer suspect. The patient did not receive prior Vaccinations within 4 weeks and didn't experienced any adverse event. She was not able to think of any family history. Investigation assessment was not reported. Concomitant medications included citalopram (CITALOPRAM) taken for depression from an unspecified start date and ongoing 40mg one a night at bed, acetaminophen;hydrocodone (ACETAMINOPHEN;HYDROCODONE) taken for arthritis of body from an unspecified start date and ongoing 10mg plus 325, started about 5 years ago, cefdinir (CEFDINIR) 100mg she thinks and doxycycline (DOXYCYCLINE) 875mg she thinks both taken for pneumonia, start and stop date were not reported, Started sometime in May. She took the COVID 19 shot a week or so after she finished these. The patient experienced nausea on 26May2021, instead of experiencing pain in her arm, extensive bruising and swelling in left thigh on 04Jun2021 and pain in left thigh on 06Jun2021 at 02:00, she reported she didn't recognize it, but it happened to catch her eye. She woke up in morning and found a new location of bruising. That was concerning her, because she had bruising in other locations of that leg in the left thigh area on the hip side. The new bruise was on the inside of thigh. She had a bruise on front part of her leg and on the side, it was really bad and was running down her leg. She was trying to get some direction because she didn't notice the symptom on the paperwork that she received. She went back to the pharmacy and they suggested she call Pfizer. She was going to talk to her primary care doctor to see if she recommends that she get the second shot. Relevant tests were not reported. Therapeutic measures were taken and the patient was treated for nausea, she has had previous reactions to the flu vaccine and she knows it was different from that, but she was having a reaction. She knows nausea was a part of it and she's been experiencing the nausea, but this with her leg was totally new, she has medication for this and was taking something for the nausea. The outcome of all the events was not recovered. Information about lot/batch number has been requested.
59 2021-06-16 oral herpes outbreak of herpes on her lip; Herpes AE: states it is getting worse, it started as one now she has ... Read more
outbreak of herpes on her lip; Herpes AE: states it is getting worse, it started as one now she has seven to eight.; tching around the site of injection, spots of itching, no pattern, little tiny red raised dots, one arm, one near ankle, bunch on her back. So small remind her of tiny insect bites.; Flu Like Symptoms; Low Grade Fever; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EW0164) via an unspecified route of administration in the left arm, on 22Apr2021 at 18:00, as 2nd dose, single dose for COVID-19 immunization. Historical vaccine included the patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EW0150) via an unspecified route of administration, as 1st dose, single dose for COVID-19 immunization. Medical history included oral herpes. Concomitant medications were not reported. On 23Apr2021, the patient experienced herpes outbreak, Arm, Itching around the site of injection, spots of itching, no pattern, little tiny red raised dots, one arm, one near ankle, bunch on her back. So small remind her of tiny insect bites, flu Like symptoms and low Grade Fever. The patient stated nothing happened with the first vaccine. The patient stated that she wanted to self report, and she had some drive time, so she was calling to self report a side effect. The patient also stated she doesn't know how common it was but she read shingles was something that was reported in rheumatology. She had an outbreak of herpes on her lip and used to getting one spot once or twice a year, usually with extreme weather changes. The patient reported that 8-12 hours after the shot, she had multiple outbreaks, 7-8 outbreaks where the lip meets the skin. The patient had called her physician to order Valtrex. The patient also stated what she saw on the websites, there have been reports of shingles outbreaks. Stated she had shingles before, but not the shingles vaccine. The patient received treatment Benadryl and Valtrex. Additional vaccines administered on same date of the Pfizer Suspect was none. Prior Vaccinations within 4 weeks was both doses of the Pfizer Covid Vaccine. The outcome of the event oral herpes was not recovered. Outcome of the event condition aggravated was unknown. Outcome of the event vaccination site pruritis was recovering. On 24Apr2021, the outcome of the event flu like symptoms and pyrexia was recovered. No follow-up attempts are needed. No further information is expected.
59 2021-06-16 oral herpes Headache, Nausea, Vomiting, Bleeding Gums, Fever Blisters, Oral Lesions. Metal Taste in Mouth. Only ... Read more
Headache, Nausea, Vomiting, Bleeding Gums, Fever Blisters, Oral Lesions. Metal Taste in Mouth. Only Able to eat soft foods. Jan-May. Took 3 rounds of antiviral. Also went to dentist because of oral pain.
59 2021-06-16 peripheral swelling MY arm is a tad swollen; It kinda hurt. It doesn't hurt unless I lay or press on it/Arm was aching a... Read more
MY arm is a tad swollen; It kinda hurt. It doesn't hurt unless I lay or press on it/Arm was aching a little bit; headache; was actually worried of getting the shot because I am on 3 different main pill (Unspecified medications) that I take every day and now I have not taken them; This is a spontaneous report from a contactable consumer (patient) from a Pfizer- sponsored program. A 59-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an intramuscular route on 07Jun2021 (at the age of 59-years) as 1st dose, single dose in the right arm for covid-19 immunisation. The patient medical history included COPD, high blood pressure, chronic lung disease (e.g., emphysema and chronic bronchitis, idiopathic pulmonary fibrosis, and cystic fibrosis), moderate to severe asthma, smoker. When confirmed if the patient had any vaccination 4 weeks prior to Pfizer COVID 19 Vaccine, patient stated, "I am supposed to go back as far as I know for second dose, 3 weeks on 28th". The patient concomitant medications were not reported. On unspecified date, the patient experienced arm was a tad swollen. It kinda hurt. It doesn't hurt unless she lay or press on it and arm was aching a little bit. Other than that she took it pretty well. She had a headache but didn't last too long. Patient stated that she has heart pills that she takes twice a day. She stopped taking it yesterday. She stated, I didn't know if it would interfere/ how it would interact with it. She also has blood thinner and acid reflux. Patient wants to knew when she can continue taking her medications. Patient was actually worried of getting the shot because she was on 3 different main pill (Unspecified medications) that she take every day and now she had not taken them. Patient stated that she didn't underwent any lab test but she took a scan like 3 or 4 month since she had anything like that then. The patient took Tylenol as a treatment for events. The outcome of the events was unknown. Follow-up attempts are needed. Information about lot/batch number requested.
59 2021-06-16 white blood cell count increased white blood cell count was very high; This is a spontaneous report from a Pfizer sponsored program. ... Read more
white blood cell count was very high; This is a spontaneous report from a Pfizer sponsored program. A contactable 59-year-old female consumer (patient) received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation; palbociclib (IBRANCE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 125 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. Historical vaccine included Pfizer Covid Vaccine, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient stated, she had a little rough patch after she got the Pfizer Covid Vaccine. The patient experienced white blood cell count was very high, and it was normally not that high on an unspecified date. The patient underwent lab tests included (PET Scan) positron emission tomogram was come back to show that my tumor had not grown and what I was shrinking. The outcome of event was unknown. The action taken in response to the event for palbociclib was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
59 2021-06-17 swelling I first developed a soft tissue knot on the arch of my left foot about 4-5 days after my 1st inject... Read more
I first developed a soft tissue knot on the arch of my left foot about 4-5 days after my 1st injection which went away after 4 days then after my second injection I developed another knot on the arch of my left foot (same spot) this time it was hard and sore (painful to the touch) then over the next couple of weeks the knot swelled up and became more painful. I contacted my Doctor and reported and have been seeking care with him since as knot has decreased in size but still exist and still swells and painful from time to time.
59 2021-06-19 swelling, peripheral swelling, swelling face Patient had the adverse reaction that evening at home several hours later at 10 pm. She had swelling... Read more
Patient had the adverse reaction that evening at home several hours later at 10 pm. She had swelling of the face, neck, eyes, and arms. She had a weird feeling in her head and balance issues. She saw a doctor for this issues. She reported to us the reaction a few weeks after the fact. most everything has resolved except the balance issues and pressure feeling in head.
59 2021-06-20 peripheral swelling 5/22/2021 I had the second dose and in 5/24/2021 I started to notice I was losing strength in my arm... Read more
5/22/2021 I had the second dose and in 5/24/2021 I started to notice I was losing strength in my arm and I could not do normal things that I do, I could not even brush my teeth, anything above me I could not pull down, the pain in my wrist and hand it was pretty bad, and it just kept escalating daily and I was doing exercises and massaging it to help relieve the pain. After 2 weeks I finally took Ibuprofen, then I went to urgent care and they gave me a shot of a muscle relaxer and a steroid because I woke up crying that day because my whole body was in pain by that time. They did a blood panel, and the result was that I have rheumatoid arthritis. They recommended to do an x-ray because my hand was very swollen. 3 weeks prior to feeling that way my doctor did a blood panel and said keep doing what you are doing because I was very healthy.
59 2021-06-21 swelling, bursitis 5 days following my first Covid vaccine I developed pronounced olecronon bursitis for the first tim... Read more
5 days following my first Covid vaccine I developed pronounced olecronon bursitis for the first time. The swelling was not resolved for weeks - - but once I took a continuous course of anti-inflammatory for over a week it did resolve. My doctor suggested that I should include this experience here as a potential consequence of the vaccine. The elbow does look changed, following the inflammation process - - there appears to be some remodelling/shape change.
59 2021-06-23 swelling patient report that after the shot she couldn't swallow, her neck was swollen , and she was short of... Read more
patient report that after the shot she couldn't swallow, her neck was swollen , and she was short of breathe, chest felt heavy, swelling on left knee
59 2021-06-24 lymph node swelling Shoulder pain; Swollen Lymph Node under Arm; Headache; This is a spontaneous report from a non-conta... Read more
Shoulder pain; Swollen Lymph Node under Arm; Headache; This is a spontaneous report from a non-contactable consumer reporting for herself. A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EL9264; Expiration date was not reported), dose 1 via an unspecified route of administration, in left arm on 07Feb2021 at 10:30 (at the age of 59-years-old) as 1ST DOSE, SINGLE for COVID-19 immunisation. Patient received no other vaccine in four weeks. The patient was not diagnosed with COVID, prior vaccination and the patient was not tested for COVID, post vaccination. The patient medical history and concomitant medications were not reported. The patient previously took Penicillin and experienced drug hypersensitivity (allergies). The patient had experienced shoulder pain, swollen lymph node under arm, headache on an unspecified date. Patient did not received treatment for the events. The outcome of the events was recovering at the time of this report. No follow-up attempts are possible. No further information is expected.
59 2021-06-24 swelling Individual woke up this morning with what she described as a pocket of fluid along her right collar ... Read more
Individual woke up this morning with what she described as a pocket of fluid along her right collar bone. She states that it is sore to the touch but not discolored. She has been using ice to help with the pain
59 2021-06-25 peripheral swelling, oral herpes, axillary mass, lymph node swelling itchy all over; sudden stabbing pain first in her left arm near her underarm but a little lower then... Read more
itchy all over; sudden stabbing pain first in her left arm near her underarm but a little lower then in the left lower leg; felt a heaviness in her arms, she couldn't move her arms/The heaviness that was in the caller's arms is now in the thighs and it was an effort to walk; swollen glands in her throat; swelling the right foot and right calf; Dizzy spells; couldn't taste her tea; petechiae and large red cherry angiomas all over the place; petechiae and large red cherry angiomas all over the place; felt a heaviness in her arms, she couldn't move her arms/The heaviness that was in the caller's arms is now in the thighs and it was an effort to walk; felt a heaviness in her arms, she couldn't move her arms; head hurt; eyes hurt; throat hurt; eye lids and under the eyes was puffy; the whites of her eyes were pinkish; tons of bumps all over the place under her arms, on her trunk and buttocks; left wisdom tooth, the gum around it, was inflamed and tender and hurt; left wisdom tooth, the gum around it, was inflamed and tender and hurt; tons of bumps all over the place under her arms, on her trunk and buttocks; itching nose; stuffy nose; sneezing like a lot like "achoo achoo achoo achoo."; teeth hurt and tingled and felt like there was metal in her mouth; teeth hurt and tingled and felt like there was metal in her mouth; upper lip of her mouth was tingling and felt cold; upper lip of her mouth was tingling and felt cold; flashes of heat in her body; This is a spontaneous report from a contactable consumer or other non Healthcare Professional (Patient, reported for self) A 59-years-old female patient received bnt162b2 (BNT162B2,Solution for injection, Batch/Lot Number: EW0187), dose 1 via an unspecified route of administration, administered in Arm Right on 03Jun2021 at 4:00 pm as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included primary immunodeficiency syndrome from Jan2019 to an unknown date (Verbatim: Primary immunodeficiency syndrome), hypotension (Verbatim: Low blood pressure) from 2018 to an unknown date Low blood pressure , hypersensitivity (Verbatim: Allergy) from an unknown date and unknown if ongoing, reaction to excipient from an unknown date and unknown if ongoing (Verbatim: intolerance to synthetic fragrances). Additional Information for Other Conditions: Latex and sulfa drugs. The patient's concomitant medications includes mitodrine (The patient takes it when she feels sluggish and its hard to breathe, usually when its raining) from an unspecified date an unknown if ongoing. Events: 2 hours after the vaccine the caller had an itching nose, a stuffy nose, then sneezing like a lot like "achoo achoo achoo achoo." The caller's teeth hurt and tingled and felt like there was metal in her mouth which there is, fillings. The Reporter's upper lip of her mouth was tingling and felt cold. Then the caller had flashes of heat in her body. On Friday 04Jun2021, the reporter woke up and was lying in bed and felt a heaviness in her arms, she couldn't move her arms. Then the caller realized she couldn't lift her arms in the shower to wash her hair and when she forced her arms it was very painful. The Reporter's head hurt, eyes hurt, throat hurt, eye lids and under the eyes was puffy, and the whites of her eyes were pinkish. The caller had tons of bumps all over the place under her arms, on her trunk and buttocks. Some of the bumps are quite large and some are smaller. The Reporter's bottom left wisdom tooth, the gum around it, was inflamed and tender and hurt and she couldn't eat on that side of her mouth or brush her tooth. The Reporter took acetaminophen and got on with the day. The caller's throat hurting got worse because there were swollen glands on Saturday. The Reporter was taking acetaminophen daily and so it masked the swollen eyes. On 05Jun2021 the reporter woke up and this time she noticed in the shower and after the shower that she had petechiae and large red cherry angiomas all over the place. They were on the caller's neck, clavicle, trunk, arm, and thighs, it was really frightening. They are now a part of the caller's body, some are larger some are smaller. There is one really large on the left abdomen and its raised and the reporter can feel that one. Most of them are fat but you can actually feel some of them. The heaviness that was in the caller's arms is now in the thighs and it was an effort to walk. The reporter also woke up with swollen glands in her throat, more on the right side, she got the injection in the right arm. The caller also had swelling the right foot and right calf. Saturday evening the reporter had a dizzy spell which was strange and she had to sit down. This improved the next day. Then the caller couldn't taste her tea. On 06Jun2021 the reporter's throat was still sore and the glands were still swollen, her eyes were still sore, her head hurt and she still had the dizzy spell. The reporter had a sudden stabbing pain first in her left arm near her underarm but a little lower then in the left lower leg, then the left eye. The reporter has had broken toes and a broken foot so she wears a compression stocking on her left toe and she has a lymph flow residual its improving every year slowly. On 07Jun2021 the reporter head and throat hurt, the glands are tender and the petechia and red cherry angiomas still present. On 08Jun2021 the inflammation around the gums subsided. The caller thinks it might have been because she took CoQ10. The caller started taking CoQ10 around that Friday or Saturday because she remembered it is good for teeth. On 09Jun2021 the reporter was itchy all over, all day. It was like prickly almost like little stabbings and itching. This improved the next day. On 10Jun2021 the reporter feels better but the petechia is still present. On 11Jun2021 the reporter feels like herself, she still has petechiae and red cherry angiomas and she has a new body. The reporter stated that these symptoms did not happen right away and that they were delayed in onset possibly because of her immunodeficiency disorder. The reporter also added that after she returned home from receiving the vaccine and was cooking later that evening she noticed her upper lip was tingling and felt "full" but she did not look in the mirror to see if it was swollen. Reporter wanted to know if she should receive the second dose of the Pfizer COVID-19 vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. Pfizer had advised to consult her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Reporter was referred to speak to her healthcare provider. There were no Investigation Assessment. Treatment received includes: acetaminophen and CoQ10 to treat the swelling and pain. The clinical outcome of the events, petechiae and large red cherry angiomas all over the place, throat hurt, couldn't taste her tea, had not recovered; Outcome of the events, itching nose, stuffy nose, sneezing like a lot like "achoo achoo achoo achoo", teeth hurt and tingled and felt like there was metal in her mouth, teeth hurt and tingled and felt like there was metal in her mouth, upper lip of her mouth was tingling and felt cold, upper lip of her mouth was tingling and felt cold, flashes of heat in her body recovered on 04Jun2021 and events, left wisdom tooth, the gum around it, was inflamed and tender and hurt, itchy all over had recovered on 08Jun2021; Outcome of the events, head hurt, eye lids and under the eyes was puffy, swelling the right foot and right calf, Dizzy spells were recovering; outcome of the events, felt a heaviness in her arms, she couldn't move her arms/The heaviness that was in the caller's arms is now in the thighs and it was an effort to walk, felt a heaviness in her arms, she couldn't move her arms, eyes hurt, the whites of her eyes were pinkish, tons of bumps all over the place under her arms, on her trunk and buttocks, swollen glands in her throat, sudden stabbing pain first in her left arm near her underarm but a little lower then in the left lower leg, The heaviness that was in the caller's arms is now in the thighs and it was an effort to walk were unknown. Information on Lot/Batch number was available. Additional information has been requested.
59 2021-06-26 peripheral swelling Numbness, tingling, and swelling in arms and swelling at the injection site for several days. Around... Read more
Numbness, tingling, and swelling in arms and swelling at the injection site for several days. Around April 24, 2021, I began experiencing swelling and moderate pain in my left hip around the surgery scar (hip surgery 2020). This muscle swelling and pain continues, particularly in the morning. Medical appointments My general physician twice and my orthopedic surgeon once because of these problems. They assess the inflammation to be an autoimmune response.
59 2021-06-29 lymph node swelling swollen lymph node under armpit on same side as vaccine 48 hours later; Discomfort on side of vaccin... Read more
swollen lymph node under armpit on same side as vaccine 48 hours later; Discomfort on side of vaccine site by collarbone the first day; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received an unspecified dose number of BNT162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727), via an unspecified route of administration to the left arm on 18Mar2021 at 0900 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks of the COVID-19 vaccine. Concomitant medications included lexipro (MANUFACTURER UNKNOWN). On 19Mar2021, the patient experienced discomfort on side of vaccine site by collarbone the first day and swollen lymph node under armpit on the same side as vaccine, on 20MAr2021 reportedly 48 hours later. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any treatment for the adverse events. The clinical outcome of discomfort and axillary lymphadenopathy was unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
59 2021-06-29 peripheral swelling, c-reactive protein increased My left leg and foot are swollen and numb.
59 2021-06-30 lymphatic obstruction developed pain in my left arm; Within two weeks it was so painful I could not move out of bed; Withi... Read more
developed pain in my left arm; Within two weeks it was so painful I could not move out of bed; Within two weeks it was so painful I could not move out of bed; developed myofascial and now it is into lymphodemia also; developed myofascial and now it is into lymphodemia also; have nerves that are entrapped and numbness in arm and fingers.; have nerves that are entrapped and numbness in arm and fingers.; unable to work; have nerves that are entrapped and numbness in arm and fingers.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Er8737 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 at 10:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Crohns disease. Concomitant medications included anastrozole, propranolol, and azathioprine. The patient previously took sulfa 12 and experienced drug hypersensitivity, humarap and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 08Apr2021 at 12:00, the patient developed pain in left arm. Within two weeks it was so painful she could not move out of bed. She developed myofascial and now it is into lymphodemia also. Also have nerves that are entrapped and numbness in arm and fingers. She was unable to work. The outcome of all the events was not recovered.
59 2021-07-01 swelling face, oral herpes Burning and swelling on the right side of my face. Breaking out in cold sores on the said side of my... Read more
Burning and swelling on the right side of my face. Breaking out in cold sores on the said side of my face. Pain and clogging in my right ear.
59 2021-07-03 c-reactive protein increased Sore upper arm with muscle and joint pain, fatigue that never went away.
59 2021-07-06 fluid retention, swelling Starting 4 to 5 days after vaccine I became short of breath and developed foot and total body swelli... Read more
Starting 4 to 5 days after vaccine I became short of breath and developed foot and total body swelling with petechia on feet and decreased urine output. I am a physician so I fluid restricted myself, wore compression stockings and took lasix. The lasix had little effect though i was able with fluid restriction to become volume depleted enough that I became orthostatic at day 10 after the vaccine with a resting blood pressure in the low seventies systolic at which point the foot swelling had not disappeared but also at which point i started taking fluids again, also with no increase in urine output which remained at less than 100 to 200 cc per day. i presumed that i was undergoing acute tubular necrosis and was waiting to see if it resolved on its own between 10 to 14 days after onset. when symptoms had not resolved by friday january 29th and I was becoming more fatigued and was 10 pounds over my normal dry weight I decided to contact my primary care physician Dr the following Monday but the next day, Saturday the 30th of January I began a huge diareses which continued through sunday and I began to feel much better. I did not contact Dr at that point as the symptoms were resolving and I did not feel that I needed any treatment. I figured at this point that I had had a reaction to the covid vaccine but after consulting other physicians at the medical center where I work it was unclear if anyone had seen such a reaction before and I contacted Dr office to report the event. His office told me they dont report the event. When I asked them why not they said because they dont. They suggested that I might be able to find a reporting form on the Phizer site. I dropped the entire incident until today when I found my vaccination card which lists this web site to file potential complications.
59 2021-07-06 lymph node swelling On May 21st I had an excessively swollen lymph node under my jaw. It did not reduce and by the 24th... Read more
On May 21st I had an excessively swollen lymph node under my jaw. It did not reduce and by the 24th I went to the Urgent Care facility near me. A mono spot was done and it was negative. The Dr. gave me an antibiotic shot and put me on antibiotics (10 days). He advised if it was not better within 24-48 hours to go to the ER. The swelling improved but did not resolve and on the 27th I returned to the urgent care for follow up. They sent me to the ER. The ER performed a CT Scan which showed that my lymph node was necrotic and that other lymph nodes were enlarged and they referred me an ENT. Dr. ordered another 10 days of antibiotics and a biopsy which was performed on June 7th. The results came back negative for cancer. I was referred to my dentist to ensure there were no abscesses. The Dentist confirmed that whatever caused the issue with the lymph nodes was not dental related. I am following up with a primary care physician and have an appointment July 9th. Please note that I had no other symptoms other than the issues with the lymph nodes. I am new to the area and had to get a new primary care physician and will pursue follow up after the initial appointment tomorrow.
59 2021-07-08 lymph node swelling On the evening of 6/18/21 a golf ball sized lump appeared on the left armpit. By 6/20/21 the lump en... Read more
On the evening of 6/18/21 a golf ball sized lump appeared on the left armpit. By 6/20/21 the lump enlarged to the size of a softball. Was prescribed oxycodone for pain and Zyrtec for the immune response. The patient took Tylenol and Motrin for the pain instead due to work obligations. On 6/22/21- the swelling had decreased back down to a golf ball and felt that the issue would continue to resolve.
59 2021-07-08 peripheral swelling Arm swollen; black and blue bruise; small lump under the skin; This is a spontaneous report from a c... Read more
Arm swollen; black and blue bruise; small lump under the skin; This is a spontaneous report from a contactable (patient). A 59-year-old non-pregnant female patient received first dose BNT162B2 (solution for injection, Batch/Lot number and expiry date was not reported, age at vaccination: 59-year-old), via an unspecified route of administration, in Arm Left on 03Mar2021 02:30 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ginkgo biloba leaf (GINKO BILOBA [GINKGO BILOBA LEAF]) and vitamins. The patient previously had codeine, dilaudid, and morphine allergies. On 03Mar2021 03:00, the patient experienced arm swollen, black and blue bruise and small lump under the skin. The patient did not receive any corrective treatment. The patient did not receive any other vaccine in four weeks. The patient was not tested positive for covid prior and post vaccination. The outcome of events was recovered. No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained
59 2021-07-11 oral herpes Outbreak of cold sores in, on and around my nose with one on my cheek under left eye.; This is a spo... Read more
Outbreak of cold sores in, on and around my nose with one on my cheek under left eye.; This is a spontaneous report received from a contactable consumer, a patient (reported for self). A 59-years-old (non-pregnant) female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot no: UNKNOWN), via an unspecified route of administration in the right arm on 19Mar2021 at 19:45 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history included transient ischemic attack (TIA) and hypertension. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASP) all for unspecified indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot number: unknown) via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 22Mar2021, approximately 3 days after second injection, the patient had an outbreak of cold sores in, on and around her nose with one on her cheek under her left eye. No cold related symptoms, so the patient was not sure if this was brought on by the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of cold sores was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
59 2021-07-12 peripheral swelling I had a swollen itchy arm and my entire body was itchy. I took Benadryl to relieve the symptoms. The... Read more
I had a swollen itchy arm and my entire body was itchy. I took Benadryl to relieve the symptoms. The swollen itchy arm lasted for 4 days.
59 2021-07-12 swelling The infected areas are best described as red, swollen, itchy, scally, and leaves a dark ring or dark... Read more
The infected areas are best described as red, swollen, itchy, scally, and leaves a dark ring or dark areas. The infected areas resemble chicken pox, ringworm, and fine bumps that look like a heat rash.
59 2021-07-15 swelling face, anaphylactic reaction Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Visual Changes/Disturbances-Severe
59 2021-07-15 swelling 6/10/21 went to ER cause headache, dizziness, hoarse,fatigue. They took EKG, Chest Xray, blood 3 tim... Read more
6/10/21 went to ER cause headache, dizziness, hoarse,fatigue. They took EKG, Chest Xray, blood 3 times cause first 2 clotted. Swabbed for Strep. all came back negative . ER doctor suggested rest, drink plenty of fluids and Ibuprofen also suggested flowwup with a primary care doctor. 6/18/21 saw ENT who send a tune up my nose to my throat where my vocals were the size of grapes. ENT prescribe Fluticasone spray 2 times a day. Still can't speak. Family Care doctor prescribe 7/2/21 Methprednisolone 21 pills
59 2021-07-17 swelling fever; pain going through arms, then legs, then left side near arm; swelling in extremities, especia... Read more
fever; pain going through arms, then legs, then left side near arm; swelling in extremities, especially fingers; tiredness; some pain in calves; This is a spontaneous report from a contactable consumer (Patient). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Jun2021 12:00 PM (Lot unknown: True, Lot unknown reason: Other, Lot unknown reason other: EW0168) (at the age of 59-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included seasonal allergies, headache, (nothing but seasonal allergies and headaches) and Known allergies: penicillin. If covid prior vaccination: No, If covid tested post vaccination: No. Facility type vaccine: Other. Concomitant medication(s) included acetylsalicylic acid (ASPRIN) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; pseudoephedrine taken for an unspecified indication, start and stop date were not reported; spironolactone taken for an unspecified indication, start and stop date were not reported. If other vaccine in four weeks: No. The patient previously took povidone-iodine [BETADINE] and experienced drug allergies (Known allergies: penicillin, betadine). The patient experienced pain going through arms, then legs, then left side near arm (non-serious) on 18Jun2021 14:30 PM, swelling in extremities, especially fingers (non-serious) on 18Jun2021 14:30 PM, fever (non-serious) on 20Jun2021, tiredness (non-serious) on Jun2021, some pain in calves (non-serious) on Jun2021. For events, pain going through arms, then legs, then left side near arm, outcome was recovered with sequelae in unspecified date in Jun2021, swelling in extremities, especially fingers, outcome was recovered with sequelae in unspecified date in Jun2021, fever, outcome was recovered with sequelae in unspecified date in Jun2021, tiredness (non-serious), outcome was not recovered, some pain in calves (non-serious), outcome was not recovered.
59 2021-07-17 swelling Right side neck swelling pressure in lower head and shoulder; This is a spontaneous report from a co... Read more
Right side neck swelling pressure in lower head and shoulder; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204) via an unspecified route of administration in the right arm on 24Mar2021 at 09:15 as a single dose (at the age of 59-years-old) for COVID-19 immunisation. The patient had a history of allergies (unspecified) to medications, food and other products. Medical history included type 2 diabetic mellitus, high blood pressure and NASH (Non-alcoholic steatohepatitis). The patient received other medications (unspecified) within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via an unspecified route of administration in the right arm on 03Mar2021 at 15:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 4:00, after 3 days of vaccination the patient had experienced right side neck swelling pressure in lower head and shoulder. The patient did not receive treatment for the reported event. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event right side neck swelling pressure in lower head and shoulder was not resolved. No follow-up attempts are needed. No further information is expected.
59 2021-07-19 lymph node pain Pain around the side and back of knee; Left elbow area pain. Believe its the lymph node.; Pain top o... Read more
Pain around the side and back of knee; Left elbow area pain. Believe its the lymph node.; Pain top of left foot.; Feels like bruised, but its not.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809), via an unspecified route of administration in the left arm on 31Mar2021 at 12:45 (at the age of 59-year-old), as a single dose for COVID-19 immunisation. Medical history included cancer, amputation, cardiomyopathy and fibromyalgia. The patient had no allergies to medications, food or other products. Concomitant medications included heart and pain medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 16:00, the patient experienced left elbow area, much pain when bending it. The patient reported it was of the lymph node, most definitely not the joint. The patient feels like it was bruised but it was not. Pain around side and back of knee and top of left foot. Not as severe as elbow area. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for feeling abnormal, foot pain, lymph node pain and knee pain. The clinical outcomes of the events feeling abnormal, foot pain, lymph node pain and knee pain was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
59 2021-07-19 peripheral swelling, lymph node swelling Right arm pit is sore; Right arm pit swollen.; Possibly the lymph nodes; This is a spontaneous repor... Read more
Right arm pit is sore; Right arm pit swollen.; Possibly the lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 29Mar2021 at 17:00(at the age of 59-year-old), as a single dose for COVID-19 immunisation. Medical history included blood pressure high, iodine allergy and shellfish allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 08Mar2021 at 17:00 (at the age of 59-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 06:00, the patient experienced under right arm, in the armpit was sore and swollen. Possibly the lymph nodes. The patient did not receive any treatment for the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events right arm pit sore, swollen and swollen lymph nodes were not recovered at the time of reporting. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
59 2021-07-19 peripheral swelling Itchy rash on right leg that moved to left leg, face, under left arm, both elbows & lower back on ri... Read more
Itchy rash on right leg that moved to left leg, face, under left arm, both elbows & lower back on right side Gradually worsened on right leg until it was purple & swollen & with peeling, burning skin. Took prednisone three different times over the course of a month. Also got nauseous & sick one day with headache and extreme tiredness & loss of smell. Took covid test- negative. Went to dermatologist who said it was extreme dermatitis & Excema. Rx given of topical steroid. Symptoms subsided after 2 weeks. Still have excena on one elbow & face- forehead, ears & chin.
59 2021-07-20 swollen extremities petechial hemes on both of my lower legs. They were inpatches as well as scattered randomly; They we... Read more
petechial hemes on both of my lower legs. They were inpatches as well as scattered randomly; They were deep red and purple in color and were notelevated or blister-like.; significant edema of my lower legs and ankles; fatigue; This is a spontaneous report from a contactable healthcare professional. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 19Mar2021 at 11:15 AM (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history included ductal carcinoma in situ (reported as DCIS), osteoporosis, psoriasis, eczema, sulfa allergy, penicillin allergy and allergy to gluten. Concomitant medications included calcium carbonate; magnesium oxide; colecalciferol (CAL-MAG-D) as a supplement from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 23:45 (one week after the vaccine), the patient experienced fatigue, petechial hemes on both of her lower legs which were in patches as well as scattered randomly. They were deep red and purple in color and were not elevated or blister-like. There was significant edema in her lower legs and ankles. Her right leg more affected than her left leg. On 27Mar2021, dermatologist suggested to get blood work to rule out low platelets. On 28Mar2021, the patient's lymphocytes were low. On 29Mar2021, the hemes seemed to be fading and leg swelling was resolved without any treatment. The patient had improvement until 31Mar2021 when new spots developed on both lower legs (looked a little different), not itchy and again fatigued. The events resulted in doctor or other healthcare professional office/clinic visit. On 31Mar2021, the patient underwent saliva pool testing and the result was unknown. The patient did not receive any treatment for the events. On 01Apr2021, the patient underwent biopsy and the result was unknown. The clinical outcome of the petechiae, purple red macule, lower leg edema and fatigue were not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
59 2021-07-25 peripheral swelling, swelling Slight Headache and arm soreness right after vaccine but then I started feeling bad - aches, body ac... Read more
Slight Headache and arm soreness right after vaccine but then I started feeling bad - aches, body aches and pain and increased reflux and started having diarrhea. I was feeling sick eating. It went off and on and off and on for awhile. Then exhaustion and it's hard to move. Joint pain and muscle cramping. I thought maybe I had Celiac Disease. I had skin rashes and I started having almost like moles that would pop up and be filled with blood and they itched like crazy. Lack of sleep but still bone tired exhaustion. Nausea is constant, I can get the heaves but I don't vomit. I made an appt with a gastroenterologist. I went in to get tested. I was told I was nuts about it being food allergies. He said I was obsessed with food. I have increased anxiety now and I have never been an anxious person. People were starting to say I needed to talk to someone for anxiety. I am feeling increased worse as days go by. I have some increased yellowing of skin and some yellowing in my eyes. I am losing weight because I can't even eat. I have pain and swelling in my mid-section. I can't sleep, can't lay on stomach (from car wreck) or either side or on my back. I get a low-grade fever and then chills. My ankles are swelling. I have chest pain, it's terrible. A couple of times, I have almost gone to ER because it feels like a heart attack. I know that it's in my esophagus, and it hurts right in the middle of my chest, it hurts when I swallow. It's like a pressure. It's hard and it's a tremendous buildup of pressure in my esophagus. Knuckles are swelling. Joint pain. I have pale stools, like a tan yellow. Goes between diarrhea to not really constipation. Lately it has been more toward normal. It's getting real hard to function.
59 2021-07-27 lymph node swelling Swollen lymph nodes on left collarbone; Fatigue; This is a spontaneous report from a contactable con... Read more
Swollen lymph nodes on left collarbone; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 at 16:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included no serious illness and had full left hip replacement. The patient had no known allergies The concomitant medication was taken by the patient (unspecified) within two weeks prior to COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6205) via an unspecified route of administration in the left arm on 05Mar2021 at 16:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 08:00, eight days after vaccine, the patient experienced swollen lymph nodes on left collarbone and fatigue day three through eleven. The events resulted in doctor or other healthcare professional office or clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the events swollen lymph nodes and fatigue was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
59 2021-07-27 swelling face, white blood cell count increased, lymph node pain Developed candida on her tongue; white blood cells were elevated; extreme face swelling; extremely p... Read more
Developed candida on her tongue; white blood cells were elevated; extreme face swelling; extremely painful lymph nodes in her neck due to swelling; Enormous fatigue; energy is still not normal; was only having some leg pain; she got the shot in her thigh; became hard to swallow; the skin is very tight; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0177; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Thigh Left on 01Jul2021 at 15:00 as dose 1, single (at the age of 59-years-old) for COVID-19 immunization. The past Medical history included ongoing ileostomy from 1997; ongoing Delta Granule Storage Pool Deficiency, diagnosed about 3-4 months ago. In Feb2021, patient had the 1st shingles vaccine, but it was applied incorrectly so she had bursitis after that. She does not have the Lot/NDC/Expiry to provide. Concomitant medications included omeprazole (PRILOSEC [OMEPRAZOLE]) taken for gastric disorder from an unspecified start date and ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19 and not received any other vaccine within 4 weeks. It was reported that after the 1st dose of vaccine the patient was okay the first day and started having a terrible reaction. On 01Jul2021, patient was only having some leg pain the evening same day and the day after because she got the shot in her thigh. It was reported patient did yoga stretches on (02Jul2021) Friday the 2nd, and the leg pain was gone by the 3rd (03Jul2021); and stated until 03Jul2021 around 15:00 she felt great. But then exactly 48 hours later after vaccination, On 03Jul2021 at 15:00, patient had extreme face swelling and pain in the lymph nodes in her neck and also had Enormous fatigue. States that she walked 7 miles the morning of 03Jul2021, then by the afternoon around 3pm it felt like she hit a brick wall. There were about 3 days where she could not move. States that her energy is still not normal; she is still very tired. On Saturday, 03Jul2021, it felt like a switch was turned and her life was changed. The swelling in her face and lymph nodes got so bad in her face and neck that it was extremely painful and became hard to swallow, so her husband took her to the ER on 04Jul2021. She saw her Hematologist on 05Jul2021 (Monday) and told her that her white blood cells were elevated and No treatment received and also she Developed candida on her tongue. States that she is on her 3rd medication to get rid of it, but it is still the same. States that the problem now is that the face swelling is not going down. She still has very big cheeks and pain in her lymph nodes. Patient visited Immunologist on 12Jul2021 due to the continued swelling and pain in her face and lymph nodes. She saw an Immunologist by video call, who she also saw before she got the shot, but he doesn't know what to do. He told her that he has never seen a reaction to the Pfizer vaccine like this before. Caller states that this is very painful because of the swelling in her neck, the skin is very tight, like she has ping pong balls in her cheeks, and she is having to hold her neck because the lymph nodes there are swollen and always hurt. States that she is a teacher and must talk a lot and it always hurts. States that it's been 12 days, it's not getting any better and she is miserable; she cries all the time. She doesn't know how to get her face back and not have this pain. States that she is on her 3rd medication to get rid of it, but it is still the same. She was supposed to get the 2nd dose on 23Jul2021, but her doctors don't think she should get it because of the reaction she has had to the 1st dose. The patient underwent lab tests and procedures which included blood test: wbc elevated on 05Jul2021. Events resulted in Emergency Room and Physician Office visit. Therapeutic measures were taken as a result of developed candida on her tongue (oral candidiasis). The event outcome recovered for Leg pain on 03Jul2021, Unknown for Drug administered at inappropriate site and white blood cells were elevated and Not recovered for rest of the events. Follow-up attempts are completed. No further information is expected.
59 2021-07-29 lymph node swelling Swollen lymph nodes just above my collar bone on each side.; This is a spontaneous report from a con... Read more
Swollen lymph nodes just above my collar bone on each side.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 30Mar2021 at 10:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication included estradiol-noreth (MANUFACTURER UNKNOWN) since an unknown date for an unknown indication. The patient had no past drug therapy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Apr2021 at 09:00, the patient experienced swollen lymph nodes just above her collar bone on each side. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event swollen lymph nodes just above her collar bone on each side was not resolved at the time of the report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GR8737) via an unspecified route of administration in the left arm on 20Apr2021 at 11:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. No follow-up attempts are needed. No further information is expected.
59 2021-07-29 peripheral swelling Chest pain; Very much sourness of breath; Cold like from inside out it was very weird; No energy at ... Read more
Chest pain; Very much sourness of breath; Cold like from inside out it was very weird; No energy at all.; Headache, started like at temples and went up to like my forehead and I really have a headache at all; Twinkling my toes; Feet were very swollen; This is a spontaneous report from a contactable consumer (patient). A 60 years old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Right on 16Apr2021 (at the age of 59 years old) (Batch/Lot Number: EN6199) as dose 1, single for covid-19 immunisation. Medical history included ongoing smoker (I done smoke). The patient's concomitant medications were not reported. Date of administration of first shot: 16Apr2021. Consumer stated, "Side effects, I had chest pain, very much sourness of breath and , I've never had this problem before ever, I done smoke, I am not over weight, I had cold like from inside out it was very weird, no energy at all, headache and it started like at temples and went up to like my forehead and I really have a headache at all, twinkling my toes and I still have that and my feet were very swollen." Product details (Expiration date, NDC#, UPC#): Consumer stated, "I have a paper for this vaccination so it says, so it has a LOT#, so if you want me to go and get the vaccination card well it will take me a couple of minutes, you want me to get it, I have to go stairs and get it". No therapeutic measures were taken as a result of events. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.