Pfizer

Immune system & inflammation symptom reports

Female, 60 - 75 years

Age Reported Symptoms Notes
60 2021-01-04 peripheral swelling, swelling face SWELLING OF HANDS AND FACE, LASTED FOR ABOUT 2 HOURS
60 2021-01-04 peripheral swelling Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm c... Read more
Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm cough; Bronchospasm cough; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Spasm; she has a lot of allergies; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 to 23Dec2020 at 0.3 mL single on left deltoid to prevent getting the COVID vaccine, for protection. Medical history included ongoing asthma diagnosed in her mid twenties, in the 80s, she had asthma when she was a child, then it stopped and resurfaced in her mid twenties, ongoing eczema diagnosed years already, a long time ago and unspecified allergies with medications. There were no concomitant medications. She received the vaccine on 23Dec2020. She has a lot of allergies in Dec2020, and had some side effects, and she got through it ok. Her side effects were some swelling of arm, a rash developed, like 5cm x 4cm at site of injection, chills and shivers, and a bronchospasm cough on 24Dec2020. Arm swelling event started 24 hours later, no more, it was stable for 24 hours, and the 3rd day, went down, was a little raised, the next day was flat but still red. She had recovered completely. The 4th day was a good day. The patient stated she had some allergy shots she had to go through before, this was no different. Rash was no more, it was gone by 27Dec2020. She was still able to go to work. Chills and shivers started 24 hours later, and took for 48 hours intermittently, she had since recovered completely. The patient stated this was all nothing different than getting like the flu shot. Bronchospasm cough event only took another 48 hours, the difference was, even when she calls it bronchospasm, it was close to when she had an asthma attack, but no chest tightness, shortness of breath, she just would cough, spasm in Dec2020 and stop. She had recovered completely. The patient stated she had no symptoms at all before the vaccine, she was healthy, she made sure nothing was going on, that she was not tired, had no cold, she took no medications for this, as she wanted to know how her body reacted and if it can handle it. They says it was ok to take paracetamol (TYLENOL), but she did not, but the second dose she would, now that she knows and she was comfortable through it. She did have some mild eczema flare ups, itchiness and sores that came up in Dec2020, but nothing to run to the hospital to the doctor for. Clarifies this occured after she received the vaccine. The outcome of the event allergies, mild eczema flare ups, itchiness and sores were unknown. The outcome of rash at site of injection was recovered on 27Dec2020. The outcome of other events was recovered in Dec2020. The causality between Pfizer COVID vaccine with some swelling of arm, rash developed 5cm x 4cm at injection site, chills and shivers, bronchospasm cough was related (Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection). Information on the lot/batch number has been requested.
60 2021-01-05 lymph node swelling, oral herpes Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in b... Read more
Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.
60 2021-01-05 peripheral swelling hand was swollen and itchy on the same arm where the injection was; back of hand was swollen and itc... Read more
hand was swollen and itchy on the same arm where the injection was; back of hand was swollen and itchy on the same arm where the injection was; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration (Deltoid Right) from 26Dec2020 15:00 at single dose for Covid-19 immunization. The patient's medical history included chronic pain and insomnia. Concomitant medications included hydrocodone and temazepam. The patient reported, "On 26Dec2020 I got my first immunization for COVID and today (30Dec2020) I woke up and the back of my hand was swollen and itchy on the same arm where the injection was". The patient further stated "It never have happened before I don't have any reaction at the injection site but it was kind of odd that it kind of showed up on the back of my hand, it feels like an allergy kind of thing." The patient tried the Voltaren Gel to try and get the inflammation down, but it didn't help, and she took some Benadryl it doesn't seem to help much. The patient's next shot is due on "12Jan2021". The outcome of events was unknown.
60 2021-01-08 lymph node swelling Arthralgia chills, swollen glands, fatigue x 2 days;
60 2021-01-10 lymph node swelling, lymph node pain Patient reported soreness/painful up into clavicle area of right side where injection occurred. Pati... Read more
Patient reported soreness/painful up into clavicle area of right side where injection occurred. Patient also reports swollen and painful lymph nodes on right side where injection occurred.
60 2021-01-10 lymph node swelling, swelling face Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache... Read more
Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache/ So much pain in my head; Couldn't talk; Complete brain fog; nausea; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (Patient) reported that received bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included Atrial fibrillation, Chronic Lyme, Lupus and Autoimmune. Concomitant medications included Metoprolol at 12.5 mg for Atrial fibrillation and acetylsalicylic acid (BABY ASPIRIN). No diabetes, no hypertension. None of the usual common diseases. Registered Nurse stated, "I received vaccine this past Wednesday. I was just talking to a couple of my colleagues and honestly I received the vac. at work. I did not really read through the paperwork and was 'weird' sharing reactions to the vaccine which for me was pretty bad reaction and thought like I need to go through your paperwork and report it. So I thought I should call and just give some information. The usual fatigue which I go to after being normal, my arm was not sore. However, as the week progressed into Friday I had a constant headache but it was manageable and then by Friday night my glands swelled, my nerves behind my ears, my neck and I was extremely fatigued, bad headache and went to bed and I had not gone out and finally I got out today I spoke with my Physician yesterday. What happened it looked like an encephalopathy but my head swelled, my face was all swollen, complete brain fog, fatigue and I couldn't talk. I was in so much pain in my head resulting in (incomplete sentence)." Lab work included the only thing is the PCR swabbing. No blood test. Registered Nurse further stated, "I don't know if that is important. But I will tell you and if it is you can send me the questions. I do have a history of Autoimmune. So my Physician thought that this was just like an enhancement of like my bodies reaction I have Chronic Lyme and I have lupus like my ANA has always been stressful. But we think that it is a family thing. No treatment for the Lyme. I did a lot of antibiotic and a lot of naturopathic stuff but that is in the past. But anyhow for anything else what I did was when I got the injection they said try and just take Tylenol not Ibuprofen but there was no way I was going to make it through with just that . So I took Ibuprofen. I called my Physician yesterday morning because I was not sure about what was is happening and I thought it might be secondary sinus infection or something else going on and it reassured me that it is definitely due to the vaccine. He said it is just your body's reaction, take the Ibuprofen, hydrate. Had me take what I had in my house Tigan for nausea. So I was extremely nauseous from the severity of the headache." Registered Nurse stated, "I just wanted to let you know what happened and the intensity of what it was because normally I would expect a headache. But this was a 'go dated'. Registered Nurse stated, "I guess the only question that I have is so do my work has this question and I was going to call my doctor tomorrow may be might know it better. I know that I have to take the second dose. But I understand the second round can be worse than the first. Is there anything that they are recommending that I can do may be prior to ease the reaction?" The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported clinical manifestations including swelling face and head swelled, which was suspected as encephalopathy by the reporting nurse, was probably related to the bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), due to temporal relationship. The subject's underlying Chronic Lyme, Lupus and Autoimmune were likely the risk factors to the onset of the 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.
60 2021-01-10 lymph node swelling Woke up morning after 2nd dose of COVID-19 vaccine with noticeable left armpit swelling (noticed whi... Read more
Woke up morning after 2nd dose of COVID-19 vaccine with noticeable left armpit swelling (noticed while applying my deodorant for the day). Swelling was the size of large lemon. Smaller amount of swelling noticed in right armpit, also. Vaccinations had both been done in my LEFT arm and greater swelling was in left armpit. Had fever, chills and headache this same day requiring me to take round the clock doses of Tylenol. By the following day, fever and chills were gone but swelling of armpit still present. Swelling is slowly diminishing but still present by day 3, as I send this notification.
60 2021-01-10 swelling 1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to t... Read more
1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to touch, swelling 3" x 3", small raised blisters. 01/11/2021: symptoms are subsiding; pink, warm to touch, swelling 2" x 2", blisters fading
60 2021-01-12 lymph node swelling The day after my arm was very soar for at least 48 hours, no fever just laying around. I had low ene... Read more
The day after my arm was very soar for at least 48 hours, no fever just laying around. I had low energy for about three weeks and I'm just now feeling better. Around the 26th my lymph nodes swelled up (three of them) . I called my PCP, he told me to take Tylenol is painful and to put warm compress if they were uncomfortable. They are still there, they don't hurt or painful.
60 2021-01-12 swelling At 4hrs post vaccination experienced extreme muscular pain between shoulder blades. The following we... Read more
At 4hrs post vaccination experienced extreme muscular pain between shoulder blades. The following week, as far as I can recall, I began to have tingling from the right shoulder blade down to my hand. I thought I may have a pinched nerve and went to the walk in clinic to be seen by the nurse practitioner that is in the same office as my primary. She examined me and thought it sounded like a pinched nerve and said I was swollen in the area of complaint. Cervical and thoracic x rays were taken (normal) and was told to take Flexeril and steroids. Pain was getting worse and primary told me to begin taking Meloxicam and have physical therapy. I have been doing both beginning 1-11-2021. Pain continues with no improvement. Do not know if my symptoms are caused from the Covid shot, but just seemed to me that it was quite a coincidence that muscle pain began on the same day as receiving the shot.
60 2021-01-14 swelling face, swelling Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection... Read more
Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection site red, BP went to 170/120, very fatigued and throat closing.
60 2021-01-14 swelling Received dose 1 of Pfizer Covid vaccine on 12/22/20, reported she noticed small bump on the side of ... Read more
Received dose 1 of Pfizer Covid vaccine on 12/22/20, reported she noticed small bump on the side of her neck the next day or so. No systemic symptoms. Did not seek treatment/evaluation. Received second dose (lot EK9231) on 1/13/21 and reports that the bump is tender and has gotten bigger.
60 2021-01-17 swelling 01/05/2021 AT 6PM: BODY ACHES, SEVERE HEADACHES. LOCAL SORENESS, SWELLING
60 2021-01-18 lymph node swelling Swelling to left axillary lymph node; This is a spontaneous report from a contactable nurse (patient... Read more
Swelling to left axillary lymph node; This is a spontaneous report from a contactable nurse (patient) reported for herself that a 60-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685) via an unspecified route of administration at left arm, on 17Dec2020 16:30 at single dose for COVID-19 immunization. Medical history included cherries and peach allergies. Patient was not pregnant at the time of this report. Concomitant medications were not reported. The nurse received the vaccine at Hospital. She reported swelling to left axillary lymph node since 17Dec2020, no treatment received, event was not recovered at the time of this report (09Jan2021). Nurse denied having COVID prior vaccination. She had tested COVID through nasal swab post vaccination which revealed negative on an unspecified date. She did not receive other vaccine in four weeks, she had the second dose of BNT162B2 (Lot number EK9231) via intramuscular at left arm on 06Jan2021 01:45 PM at single dose for COVID-19 immunization. Outcome of the event was not recovered.
60 2021-01-19 swelling face Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. To... Read more
Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. Took Tylenol Day 6: diagnosed with Bells Palsy by PCP 1/8: went to doctors for evaluation by PCP of symptoms currently patient still experiencing swelling of the right side of face and slight itching
60 2021-01-21 lymph node swelling right deltoid pain, fatigue, headache, neck pain, low back pain, right axillary lymph node swollen/d... Read more
right deltoid pain, fatigue, headache, neck pain, low back pain, right axillary lymph node swollen/discomfort
60 2021-01-25 peripheral swelling Very swollen and erythematous arm; Very swollen and erythematous arm; chills; severe neck pain; myal... Read more
Very swollen and erythematous arm; Very swollen and erythematous arm; chills; severe neck pain; myalgias; This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient (not pregnant) received first dose of bnt162b2 (Lot number: Ek5730), via an unspecified route of administration in left arm on 22Dec2020 11:30 at single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing (COVID prior vaccination: Yes). There were no concomitant medications. The patient experienced very swollen and erythematous arm, chills, severe neck pain, myalgias, all on 22Dec2020 14:00. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment given. The outcome of events was resolved. Facility type vaccine: Hospital. No other vaccine in four weeks. No other medications in two weeks. No COVID tested post vaccination. Not known allergies or other medical history.
60 2021-01-27 lymph node pain, lymph node swelling arm pain; light headedness; abdominal pain; swollen, tender lymph node left axillary area; swollen, ... Read more
arm pain; light headedness; abdominal pain; swollen, tender lymph node left axillary area; swollen, tender lymph node left axillary area; This is a spontaneous report from a contactable nurse (patient). A 60-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK4176; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 08:30 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no known allergies. There were no concomitant medications. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 18Dec2020 10:30 at a single dose for covid-19 immunization. The patient experienced arm pain, light headedness, abdominal pain and swollen, tender lymph node left axillary area on 08Jan2021 04:00 PM. The patient received treatment for the adverse events includes acetaminophen (TYLENOL) and ibuprofen (MOTRIN). The outcome of the events was recovered on in Jan2021.
60 2021-01-27 lymph node pain Had normal site pain, fatigue and began running fever of about 100.0 the evening of injection howeve... Read more
Had normal site pain, fatigue and began running fever of about 100.0 the evening of injection however the fever has continued x7 days, getting as high as 101.9. I began noticing soreness in the lymph nodes in my neck and underarms on the evening of 1/25 and that lasted until midmorning of 1/27.
60 2021-01-27 peripheral swelling Red, warm rash around injection site cold sweat, chills, and swelling to Left arm
60 2021-01-28 lymph node swelling FLU LIKE SYMPTOMS STARTED 3AM 1/29/2021 WITH GENERALIZED BODYACHE, LEFT AXILLARY PAIN, TENDER LEFT C... Read more
FLU LIKE SYMPTOMS STARTED 3AM 1/29/2021 WITH GENERALIZED BODYACHE, LEFT AXILLARY PAIN, TENDER LEFT CERVICAL NODES, HOT AND COLD FLASHES AND HEADACHE. NASAL CONGESTION.
60 2021-01-28 swelling, lymph node swelling Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain ... Read more
Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain Headache
60 2021-01-29 swelling 2? diameter redness/swelling, soreness, some itching, resolved after 2 days
60 2021-01-31 lymph node inflammation 6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days... Read more
6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days later 12 hrs after vaccination: Nausea, vomiting, headache, body aches, fever (100.7 at peak), chills. Lasted approximately 36 hours. 48 hours after vaccination: vaccinated arm has tingling sensation and weakness when raised, armpit lymph nodes tendor/sore - still have this symptom 3 days later. Took Aleve to alleviate symptoms. It lessened them somewhat but I was still not able to function fully for several days.
60 2021-02-01 anaphylactic reaction Systemic: Anaphylaxis-Severe; symptoms lasted 1 day
60 2021-02-01 lymph node swelling 6 days after injection, I noticed a 5x5 cm sized lump under my left arm.
60 2021-02-04 lymph node swelling Radiating pain the first night in the arm and in the muscle behind her breast. Continual head ache w... Read more
Radiating pain the first night in the arm and in the muscle behind her breast. Continual head ache with fatigue and sore throat swollen glands since the vaccine in the evenings.
60 2021-02-06 swelling face Swelling of face & throat; rapid heart beat Hospital I received, a steroid shot & Hydroxyzine pill a... Read more
Swelling of face & throat; rapid heart beat Hospital I received, a steroid shot & Hydroxyzine pill and Rex?s + contact regular doc 3 Rx-1) 40 mg Prednisone for 4 days 2) Hydroxyzine 25mg as needed 3) Epi pen RETURNED TO ER 2/5/21 same symptoms after taking prednisone; told to take Hydroxyzine even though I have no rash & rare itchiness. ON GOING SYMPTOMS; UNRESOLVED
60 2021-02-07 lymph node swelling Swollen glands; severe headache; muscle pain; extremely tired; body hurts; This is a spontaneous rep... Read more
Swollen glands; severe headache; muscle pain; extremely tired; body hurts; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number El3248/expiration date: unknown), via unknown route of administration, on 09Jan2021 12:30 PM (at the age of 60 years old) as a single dose on left arm for COVID-19 immunisation for COVID-19 immunisation at a Public Health Clinic/Veterans Administration facility. Relevant medical history included breast cancer last year. The patient had no allergies to medications, food or other products. Relevant concomitant medications were not provided. 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. It was reported that the patient experienced swollen glands, severe headache, muscle pain, extremely tired, body hurts on 14Jan2021. The outcome of the events swollen glands, severe headache, muscle pain, extremely tired, body hurts was not recovered. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19.
60 2021-02-07 peripheral swelling high fever/100.1 degrees Fahrenheit/100.8 degrees Fahrenheit/99.8 degrees Fahrenheit; arm swelling; ... Read more
high fever/100.1 degrees Fahrenheit/100.8 degrees Fahrenheit/99.8 degrees Fahrenheit; arm swelling; arm was very sore; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via an unspecified route of administration in left arm on 20Jan2021 15:15 at single dose for COVID-19 vaccination. Medical history included ongoing coeliac disease diagnosed four years ago in 2017, allergic to dairy and corn, COVID in Nov2020. There were no concomitant medications, no other recent vaccinations and had started no new medications. The patient had a reaction with a high fever, a headache, and her arm was very sore after vaccination, that were similar to how she felt when she had COVID in Nov2020. The patient's arm was swollen and sore that evening on 20Jan2021. Her first fever was yesterday morning on 21Jan2021, probably at about 10:00AM or 11:00AM, and at that time it was 100.1 degrees Fahrenheit then later in the afternoon at 02:00PM it was 100.8 degrees Fahrenheit. She took Tylenol, applied cold moist cloth, drank lots of liquid for treatment, and she did sleep. Tylenol was clarified to be generic pain reliever, Acetaminophen 500mg. Acetaminophen 500mg, EXP Apr2021, LOT P114992, UPC: 1191717759. Her temperature improved after taking this medication, and it was 99.8 degrees Fahrenheit before bed. She hadn't taken any Acetaminophen this morning on 22Jan2021, but she took two tablets the first time yesterday on 21Jan2021 and then one tablet right before bed. She didn't go to the doctor for this. The outcome of events was unknown.
60 2021-02-08 lymph node swelling, swelling face her face got swollen; lymph node right there it was extremely swollen and very tender and very painf... Read more
her face got swollen; lymph node right there it was extremely swollen and very tender and very painful; She had a lump at the site of the injection; chills; headache; flu like symptoms; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine , via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation . Medical history included hypertension. Concomitant medication included telmisartan (MICARDIS). On 30Dec2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced her face got swollen on an unspecified date with outcome of unknown , lymph node right there it was extremely swollen and very tender and very painful on an unspecified date with outcome of unknown , she had a lump at the site of the injection on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown , flu like symptoms on an unspecified date with outcome of unknown. The events swollen face and lymph adenopathy were considered important medical Events. The remaining events were considered non serious. The patient stated she got the second vaccine shot of Pfizer on Wednesday the 20Jan2021. She got like a weird side effect like under her armpit it got really swollen and painful, like the lymph node right there it was extremely swollen and very tender and very painful. It still is but not as much. The next day the right side of her face was swollen The patient received Tylenol as treatment for the events. Follow up information has been requested.
60 2021-02-09 lymph node swelling Axillary lymph node-grape size, on side of injection site painful, movable and tender 5 days after t... Read more
Axillary lymph node-grape size, on side of injection site painful, movable and tender 5 days after the vaccine injection. No longer tender but still same size
60 2021-02-09 lymph node swelling lymphadenopathy along the left collar bone; This is a spontaneous report from a contactable other hc... Read more
lymphadenopathy along the left collar bone; This is a spontaneous report from a contactable other hcp (patient). This 60-Year-old female no pregnant patient received,at hospital, the second dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from lot# EL3246 on left arm on 14Jan2021 07:30 at SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. No other vaccine in four weeks.The patient previously took ibuprofen and experienced drug hypersensitivity.First dose details : lot number=EK9231,administration date= 24Dec2020,administration time= 07:30 AM,vaccine location= Left arm,dose number= 1.The patient experienced lymphadenopathy along the left collar bone on 16Jan2021 06:00 .No treatment received.Event outcome was not recovered. No covid prior vaccination,No covid tested post vaccination.
60 2021-02-10 lymph node pain Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the ne... Read more
Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the neck. Then my arm pit was swollen, hot and the swelling went down my arm. I also had diarrhea, Nausea, slight head ache, chills, body ache with a temp of 101.5. Went to the doctor yesterday because of my armpit swelling, hot to touch and it had a red band. She said where they gave it was not in a muscle. It was given sub Q & that it went into my lymph gland and leaked down my arm to swell. Right now I just have on and off nausea , pain in my lymph glands in my arm pit. The swelling and pain has gone down and the other symptoms have faded away.
60 2021-02-10 swelling, axillary mass For about 24 hours soreness in left arm near injection site, more swelling and a lump under left arm... Read more
For about 24 hours soreness in left arm near injection site, more swelling and a lump under left arm and burning sensation under left arm and chest area where I typically have swelling and numbness due to lymphedema post mastectomy. Resolved within 24 hours with no treatment.
60 2021-02-14 swelling face 2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYE... Read more
2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.
60 2021-02-16 swelling face facial swelling, facial stinging, flushing approximately 45 minutes after vaccination. Persisted ~12... Read more
facial swelling, facial stinging, flushing approximately 45 minutes after vaccination. Persisted ~12 hours
60 2021-02-17 fluid retention, peripheral swelling This is a spontaneous report from a contactable consumer. A 60-year-old female patient received sec... Read more
This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, subcutaneous on 20Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included diabetes, anaemia, blood pressure, cholesterol. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EU9899, in the left arm on 30Dec2020 15:00 at SINGLE DOSE for COVID-19 immunization and experienced swelling and redness at the site. Concomitant medications included liraglutide (VICTOZA), labetalol (LABETALOL), diltiazem (DILTIAZEM), valsartan (DIOVAN), rosuvastatin, metformin, aspirin and iron. The patient thinks that it wasn't given to her intramuscularly. This is a potential inadvertent subcutaneous administration of the BNT162B2. This patient received her second dose on 20Jan2021 on the side of her arm and reported that it was swollen, red, and hot, but has gotten 100 times better' over the last 6 days since administration. She was asking for efficacy of the incorrectly administered dose. It was further stated that in the middle of the night, her arm was red almost like a little bullseye and she said that she was getting burning, and pins and needles down her arm, and a fullness in her hand like her hand was swollen. She said that she still kind of feels it. As the days progressed on day 2, 3, and 4, the swelling got more intense, the circular red swollen area got worse to the size of like a small baseball. She was feeling okay other than that. Today was day 6 and it was not as red and was more black and blue, swelling went down 80 percent, she still feels a little bit of the pins and needles and the fullness in her hand. She said that there was like a big knot that was very hot. It was a hard like knot at the injection site. The injection site was really big, round, hot, red, and had a knot that lasted; adds it is still there but 99% better; and she had tingling down her arm with pins and needles in her hand. She noticed it was little red a couple of hours, like 8 hours later; but by the next day it was circular, more red, swollen, itchy, and burning down her arm. By the third day, the site had a big, red, hard knot; still burning down her arm and with pins and needles down her arm. She added that her hand felt like a fullness in her hand filled with fluid. By Friday the swelling at the site was gigantic. The site swelling is improved but the redness was more of a black and blue now. Her arm has been very dark red, discolored, swollen, painful and has nerve pain described as "hot tingling down the arm like pins and needles" to her hand. She states that she has a very large knot at the injection site. This was in her non-dominant arm. She spoke with two of the pharmacists that she works with and they looked at her arm and both felt like she may have received the injection subcutaneously instead of intramuscularly. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
60 2021-02-17 lymph node swelling Fever 101, Muscle and Joint aching, tired. Lymph node swollen in left armpit
60 2021-02-17 peripheral swelling This is a spontaneous report from a contactable consumer. A 60-year-old female patient started to re... Read more
This is a spontaneous report from a contactable consumer. A 60-year-old female patient started to receive bnt162b2 (manufacturer unspecified), lot number: EL4238, via an unspecified route of administration in the left arm, on 21Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included arthritis. Patient's known allergies are Penicillin, Peanut and Dairy. 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 hasn't been tested for COVID-19. There were no concomitant medications. The patient's whole/entire arm was killing her; she was hurting across her shoulder blades down to fingers. Her elbow and wrist were hot and she was feeling a tremble in hand which she has never had before. She later added that her joint in elbow and shoulder was now reaching down to her arm. She couldn't even wear her watch today to her work, it felt swollen, like there was liquid in it. She also can't lift her arm, move and the pain was like going into her back. The patient was taking Aleve and Advil and "it doesn't take away all but it takes away enough that she can function." She also bought a topical ointment to help numb the area and she was wearing a pain patch on my back. The outcome of events was reported as 'not recovered'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
60 2021-02-25 swelling face Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some... Read more
Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some shortness of breath.
60 2021-02-28 lymph node swelling Swollen and very sore lymph glands in left armpit/chest with pain/tenderness on the underside of arm... Read more
Swollen and very sore lymph glands in left armpit/chest with pain/tenderness on the underside of arm where injection was given; ice was used to reduce swelling and was alternated with heating pad. soaked in warm bath with epsom salts. relief was finally achieved by taking 1 Aleve liquid gel capsule - 220 mg. Swelling and pain began within 24 hrs after injection and pain increased intensely by hour 36. Some tenderness to touch still in lymph glands in armpit/chest and to underside of arm. minimal tenderness at actual injection site - no more than normal for a injection.
60 2021-02-28 peripheral swelling Pfizer. My right hand was swollen up like a catchers- mit. Very painful in thumb joint at a level ... Read more
Pfizer. My right hand was swollen up like a catchers- mit. Very painful in thumb joint at a level 10. Was swollen for 5 days, then fever chills, body aches (fever 0f 100.2) Right hand was so painful was intolerable, truly had to wait for it to pass, nothing helped except for soaking in Epsom salt bath, which was short live. Have had arthritis in this thumb but not for approximately 8 years. Entire hand was swollen and not useable.
60 2021-03-01 c-reactive protein increased Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had pa... Read more
Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had patient remove mask and reported facial drooping. Transferred to ED for acute, painless, unilateral facial paralysis with no forehead sparing most likely secondary to Bell?s Palsy. Patient was monitored and discharged with prescriptions for valacyclovir 1000mg tid and prednisone 50mg qday x 7 days
60 2021-03-01 c-reactive protein increased Vaccine given 2/9/21. On the afternoon of 2/12/21 I began to have joint pains in my right wrist. By ... Read more
Vaccine given 2/9/21. On the afternoon of 2/12/21 I began to have joint pains in my right wrist. By 2/10/21 in the morning both elbows, knees and wrists were sore. Elbows and right knee felt warm to the touch. Nodules or red spots developed around the joints. I could barely walk or climb in and out of the car, the bed, and had a very difficult time standing up from the toilet or a low chair or couch. No fever, but did have a few chills with teeth chattering at least twice.
60 2021-03-03 lymph node swelling SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSE... Read more
SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSEA, SWOLLEN LYMPH NODES UNDER BOTH ARMS, FEELING UNWELL
60 2021-03-04 lymph node swelling Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on m... Read more
Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on me, I immediately tasted something weird in my mouth. It was not as metallic tasting as usual. More plasticy. Shot did not hurt. Was told to stay in 30 minutes waiting area.I did. The taste remained in my mouth. I left at 10:34 am feeling OK, except for weird taste. As I drove off the parking lot, I noticed that my mouth and tongue were tingling, with worst of it on my left side. My throat did not seem to be affected, so I continued driving. Some nasal congestion and coughing. The tingling turned into numbness in my mouth and tongue, all the way back to top of throat. I called my primary care doctor at 12:10 pm and left a message. I received a call back at 2:15 pm from nurse. She told me to take Benadryl and have someone take me to Urgent Care right away to get my vitals checked. I did not take Benadryl, as CDC said it could mask anaphylactic reaction. I called a friend and she took me . I noticed that my lymph nodes in my neck were swelling and painful. We arrived at 2:45 pm. My vitals were checked, heart and breathing listened to and was checked briefly for swelling in mouth and throat. There was no swelling. He said he had never heard of this tingling reaction and claimed it is just a side effect and not a serious reaction and that it would probably last a couple of days. He recommended that I watch for new symptoms and take Benadryl. That was $30. We left at 3:10. We left. I noticed that the numbness was spreading to my lips and up the left side of face and I was getting super tired. Also, my mid to lower back started hurting a lot. I took a Benadryl. 4:30 pm still have same numbness. My eyes got super dry and itchy. My head started to hurt. Some coughing. 5:10 pm dry eye and numbness, more swollen lymph nodes and chills. Pain in calves, upper back, same on both sides. 6:38 weirdly, from the bottom of my thumb to halfway up my arm there is pain. Both arms simultaneously. Worse on the left. 8:11 pm after bundling up and using a heating pad, plus extra heat, chills are lessened. Lymph nodes very sore in neck. Eyes are not quite as dry. Everything else is the same. 8:48 pm jaw really aches. Intestinal discomfort. Going to bed. 10:39 pm pain from jaw extended up into left ear. Upper part of throat hurts. March 5, 2021 4:00 am. Body aches have lessened. Left arm sore at shot area. 5:45 am eyes definitely dry, but not nearly as dry as yesterday. Numbness in mouth , tongue and face has lessened, but still uncomfortably present. Definitely worse on the left side. Little bit of tingling on the left, mostly on cheek from chin to ear. Headache gone. Lymph nodes sore and swollen . 7:00 am went on a walk. Noticed some achyness throughout body. Very tired. 10:51 am The tingling and numbness remain in my mouth, tongue and cheek up to my left eye. Very tired. Lymph nodes still swollen and sore.
60 2021-03-04 peripheral swelling Red, itchy, bumpy, swollen rash on right shoulder extending to right breast. Swelling of left hand... Read more
Red, itchy, bumpy, swollen rash on right shoulder extending to right breast. Swelling of left hand, stiffness, hard to move fingers, same rash as above between fingers.
60 2021-03-04 swelling face I received vaccine. Noted at the 30 minute post wait vaccine site feeling a very slight like it was ... Read more
I received vaccine. Noted at the 30 minute post wait vaccine site feeling a very slight like it was hard to take a deep breath 15 minutes after receiving the vaccine. I took my pulse. It was 90. I did not tell the medical monitor people. My husband drove me home after the 30 minute watch period was up. At 1:15pm I gave myself an albuterol neb to. Post tx home pulse ox was 95% pulse 96. No n/v, no itching. Breathing felt improved . I did a home peak flow reading which was 240. My personal best baseline is 350. I auscultated my anterior chest. Diminished, clear, no wheezing. I sat calmly. My husband noticed the left side of my face was mildly swollen. Amazing! For him to notice! it was very slight around cheek bone to jawline. I sent him to get otc Benadryl. I took 25 mg po . At 2:20 pm Pam was 300 p02 sat 98% pulse 96. Lips felt tingling, no swelling. Speech clear. Swallowing intact Drank water, low sodium soup. 3:30 pm did another albuterol next. Sat 95% after neb . Pulse 89. 20 minutes post neb peak flow reading 320. Started feeling chills. Temp outside a nice seventy degree day. Wrapped self 6 blankets,winter hoody fleece, heating pad and finally fell asleep. Family watched me sleep. Woke up 7pm. Still felt cold. Had fluids, urinated, breathing ok. Went back to sleep. 11 pm woke up, peak flow 300, did neb, took Benadryl wore my cpap machine and went to bed till today.
60 2021-03-04 swelling face 4 hours after vaccine, had the following Reaction : -Big Chills -Nausea -Small amount of swelling o... Read more
4 hours after vaccine, had the following Reaction : -Big Chills -Nausea -Small amount of swelling on Face, Ankles, & Wrists -Very tired = fatigue / sleep
60 2021-03-06 peripheral swelling Swollen arm,unable to lift,unable to lay on,achy arm and wrist,tingly fingers from 7pm same day til ... Read more
Swollen arm,unable to lift,unable to lay on,achy arm and wrist,tingly fingers from 7pm same day til 3:30 next day(Friday March 5)Slept all day,made appointment with Primary, took dosages of Ibuprofen
60 2021-03-07 swelling, swelling face On the day of the shot, by Noon I could feel the vaccine moving into my throat and my face. My thr... Read more
On the day of the shot, by Noon I could feel the vaccine moving into my throat and my face. My throat and left cheek started to swell and turn slightly red. I took more Benadryl and called my allergist in the afternoon. They told me I needed to get to the hospital for treatment. At the hospital, they gave me steriods, benadryl and Pepcid in an IV. After allowing this to work, they sent me home with a steriod prescription for 60Mg for the next 5 days. They asked me to follow up with my allergist if I had other issues , they also told me that I would not be able to get the 2nd dose of the vaccine. Over the next several days, I continued to have issues with this redness that had grown over my entire face. I looked like I was totally sunburned. I did not feel well, the redness was very hot, and I struggled with some breathing. I made an appointment on Monday morning with my allergist, and they adjusted my allergy medicine and gave me more asteroids for 5 more days. They advised me to use my nebulizer treatments as needed to remove the heaviness in my chest. This redness and swelling has moved around my body, almost as if I can see where the vaccine is at in my body. It went from my head to my chest/back and right arm. Down to my abdomen, and then down below my knees. In the morning, it is usually in my face and then it moves around during the day. I can feel this fluid moving around in my body because the redness brings swelling/fluid. This last saturday 3/6/2021 was horrible, it was in my right ear and right foot. It was very painful and made me very dizzy. I struggled to walk. Then on Sunday morning, I felt fine all day. Today Monday, it feels like it is in my right foot again, but I feel like It is getting better.
60 2021-03-07 swelling swelling, itchy spots: , itchy knot on hip, itchy spots: under breasts, ears, and palms-- swollen li... Read more
swelling, itchy spots: , itchy knot on hip, itchy spots: under breasts, ears, and palms-- swollen lips
60 2021-03-08 swelling face Facial swelling and total body itching
60 2021-03-09 peripheral swelling FLARE OF A RASH ON MY LOWER LEGS, HIGHLY INFLAMED AND SWOLLEN, DR. PRESCRIBED TRIAMCINOLONE ON 02/12... Read more
FLARE OF A RASH ON MY LOWER LEGS, HIGHLY INFLAMED AND SWOLLEN, DR. PRESCRIBED TRIAMCINOLONE ON 02/12/21. IT IS BETTER BUT NOT GONE AT THIS TIME.
60 2021-03-10 lymph node swelling, lymph node pain My Arm Pit and my Breast on my right side of my body became so painful as if I had a major injury or... Read more
My Arm Pit and my Breast on my right side of my body became so painful as if I had a major injury or surgery. Tylenol and Aspirin could not control the intense pain. The pain was excruciating!! I also had aches, fever, chills and tender lymph nodes in my neck. The excruciating pain last 3-4 days. 7 days later I still have tenderness in my breast and arm pit.
60 2021-03-10 swelling face, peripheral swelling On March 6, I experienced swelling of the face, hands, throat accompanied by hives/rash over body.
60 2021-03-11 swelling 1538 Patient received vaccine and felt neck swelling and chest tightness.
60 2021-03-11 white blood cell count increased Patient administered Covid Vaccine (Pfizer, 1st dose) at approximately 2:46PM. At approximately 150... Read more
Patient administered Covid Vaccine (Pfizer, 1st dose) at approximately 2:46PM. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance 1526: 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.
60 2021-03-14 lymph node swelling swollen lymph nodes; tiredness; diarrhea; This is a spontaneous report from a contactable consumer (... Read more
swollen lymph nodes; tiredness; diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 10Feb2021 09:15 at single dose for COVID-19 immunisation in workplace clinic. The patient's medical history included AFib, hypertension, known allergies: TB test (allergies to medications, food, or other products: TB test). Concomitant medications included apixaban, digoxin, metoprolol, enalapril; the patient received all the drugs within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), in left arm on 20Jan2021 09:15 AM 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 was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On an unspecified date in 2021, the patient experienced swollen lymph nodes, tiredness, diarrhea. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was recovering.
60 2021-03-15 swelling face This patient was vaccinated approximately 1 hour prior to presentation here with her first dose of t... Read more
This patient was vaccinated approximately 1 hour prior to presentation here with her first dose of the Pfizer COVID-19 vaccine. She felt fine right after her vaccination but as she drove to her destination where she was going to take a walk, she started to develop left-sided facial burning and swelling. That prompted her to call her PCP in that office recommended she come back to the vaccination clinic to be evaluated. I evaluated her at approximately 2 PM.. She was feeling well for the most part with the exception of left-sided facial burning and swelling and a little bit of redness over her left cheek. She denied fevers, chills, itching, other areas of rash, difficulty speaking, difficulty swallowing, tongue swelling, lip swelling, wheezing, chest pain, or difficulty breathing. She recalls a penicillin allergy at age 5 or 6 but cannot remember the reaction. She has never reacted to a vaccine before. Initial vital signs included a blood pressure of 134/73, a pulse that was 70 and regular, and an oxygen saturation of 100% on room air. She had normal mental status and her lungs were clear. The left side of her face was slightly swollen over her left cheek as compared to the right with some slight increased flushing on the left side. There was no stridor, she was speaking comfortably, and her lungs were clear with good airflow. Her heart demonstrated S1 and S2 with regular rate and rhythm. I administered 2 doses of Benadryl, 25 mg with each dose about 15 minutes apart with her last dose at approximately 2:25 PM. I rechecked her vital signs at 2:50 PM and her blood pressure was 138/79 with a pulse of 70 and regular and an oxygen saturation of 99% on room air. Her lungs were clear and she was moving good air. I did take a relook at her face which was improved with decreased swelling. At 3 PM, because she was doing much better, I discharged her to home with instructions to use Benadryl 50 mg when she got home and then 25 to 50 mg every 4 hours today. If she develops any respiratory symptoms such as difficulty swallowing, cough, breathing difficulty, swollen tongue or swollen lips, as well as increased facial swelling, she will call 911 to be evaluated. She should not get the second Pfizer COVID-19 vaccine.
60 2021-03-16 swelling face As I pulled up for the 15 minute wait period the symptoms started 5 minutes after I received my vacc... Read more
As I pulled up for the 15 minute wait period the symptoms started 5 minutes after I received my vaccine. A tingling feeling up my left arm to back of my neck. My neck stiffened and then my throat started to close. Not to where I can't swallow but just like when I eat food that I'm allergic too, it closes up. The nurse that was overseeing me was holding the umbrella over my car window with the rainfall. All of a sudden their was lightning & thunder. The nurse threw the umbrella because she was shocked from the lightning. She started to talk to all the other around her and forgot about me. Since I could still swallow I didn't get her attention. When she returned she asked me the time so I had to pull my phone out. She didn't know the time of my 15 minutes and sent me away. As soon as I got out of the parking area but still inside amusement park, I started to feel my cheeks becoming numb and my right eye was blurry. I quickly moved over to the side lane still inside of amusement park and waited. I called my husband and told him that with the heavy rain I didn't feel safe driving with my right eye being blurry. I waiting another 15 minutes before driving home. That evening the blurriness came back, my eye's & forehead was tender to touch but no headache. Only pressure in my head. My symptoms of closed throat, swollen cheeks, pressure in my head and blurriness continued on Friday, March 12th, Saturday, March 13th, Sunday, March 14th and Monday, March 15th. As of today, no other systems other than feeling my body has inflammation.
60 2021-03-16 swelling face 40 hours after COVID-19 mRNA vaccination patient awoke in the middle of the night with itch, swellin... Read more
40 hours after COVID-19 mRNA vaccination patient awoke in the middle of the night with itch, swelling, rash on left eyebrow. Subsequent 6 days rash developed into typical herpes zoster (shingles) rash localized over left eyebrow.
60 2021-03-17 lymph node swelling swollen lymph nodes (felt like a lump) in neck and rash on lower lip and chin
60 2021-03-17 lymph node swelling Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness ... Read more
Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness and soreness in arms; Heaviness and soreness in arms; has a sore spot only where the COVID vaccine was; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN9581), via an unspecified route of administration on 04Feb2021 at 10:20 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included ongoing multiple sclerosis. There were no concomitant medications. The patient previously received the first dose bnt162b2 (Lot: EL3249) on 14Jan2021 for COVID-19 immunisation and experienced couldn't re stand. The patient experienced could stand, couldn't walk on 05Feb2021, frontal headache, heaviness and soreness in arms on 04Feb2021, swollen lymph nodes in left arm on 05Feb2021, neck ache on 04Feb2021 at 22:00, had a sore spot only where the covid vaccine was in Feb2021. Event details: The patient had the second COVID vaccine on 04Feb2021. Was fine that day. Had heaviness in her arm and little bit of headache. Was fine the day of the shot. 04Feb2021, felt a little heavy in the arm where she got the COVID shot. Received COVID vaccine in left arm. Drove home and was fine. Sat down and watched TV and had a frontal headache. Took Tylenol. By the time she went to bed, around 10:00 PM, her neck was so sore to turn from side to side. On top of her arms where shoulder pads would be is there the heaviness was. Both arms became sore. It was manageable and she took Tylenol. Eventually it went away. Friday morning 05Feb2021 when she got up, got to the point where she got out of bed and couldn't get up. There was no possible way for her to get up. Her husband had to buy her a 3-in-1 potty chair so she could just stand and pivot, seriousness was provided as disabling, could understand hospitalization, but confirmed she never went to the hospital. Could not rest that day or go back to the bathroom. Didn't walk anywhere. Was in a chair that she could sleep in. Husband bought her a potty chair. Was able to use the lift on the lift chair later that afternoon. Definitely debilitating. Sister who was an orthopedist nurse had to help her and secured she wouldn't fall. The patient had swollen lymph nodes only in the left arm on 05Feb2021. At time of reporting the patient had a sore spot only where the COVID vaccine was. It was not red. Only sure up underneath and when it was touched. The outcome of events could stand, couldn't walk, heaviness and soreness in arms was resolved on 06Feb2021, outcome of other events was unknown.; Sender's Comments: Based on available information, due to close temporal association, a possible contribution roe of bnt162b2 to the onset of "unable to walk" cannot be excluded. 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.
60 2021-03-18 lymph node swelling pt. called stating she recieved her first COVID vacc. past weekend, now having swollen lymph nodes a... Read more
pt. called stating she recieved her first COVID vacc. past weekend, now having swollen lymph nodes and trouble swallowing. Pt. was advised to go to UC or ER. Pt. presenting today for Swollen glands (had 1st dose vaccine on Saturday, Monday started having swollen glands in neck
60 2021-03-18 swelling Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fat... Read more
Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fatigue Day 3: unable to lift left arm, headache Day 4: sore arm, 3" oval shaped red spot next to shot spot: swollen, raised, itch Day 5: arm better, red spot still itch Day 6: able to lift arm, less sore, red spot smaller, still itch, shot spot still itch too Day 7: arm almost back to normal, red spot diasppeared Day 8: all 10 toes red, swollen, extremely itch, unbearable especially at night Day 9 - 10: different toes itch more each night Day 11 (3/17): visited urgent care - diagnosed fungal infection Day 11: visited Primary Care Physician : referral to visit Podiatrist Day 13 (3/19): visited Podiatrist - diagnosis COVID Pfizer Vaccine side effect, prescription: Betamethasone
60 2021-03-19 c-reactive protein increased, high blood cell count Pt was admitted 6 weeks post second covid vaccination with c/o sudden onset of generalized abdominal... Read more
Pt was admitted 6 weeks post second covid vaccination with c/o sudden onset of generalized abdominal pain, nausea, vomiting and diarrhea resulting in 2 syncopal episodes. CBC showed leukocytosis with neutrophilia which resolved. She was treated with IV fluids and antiemetics and was discharged on 3/19/2021
60 2021-03-19 lymph node swelling Swollen Lymph Nodes under arm where shot was given,; Flue like symptoms - no doctor visits yet
60 2021-03-19 peripheral swelling The patient's arm was slightly red in color and swollen. When felt, there seemed to be a lump where ... Read more
The patient's arm was slightly red in color and swollen. When felt, there seemed to be a lump where the vaccine was given after 5 days.
60 2021-03-20 lymph node swelling Large swelling in lymph node above left clavicle the size of a 50 cent piece Injection in the lef... Read more
Large swelling in lymph node above left clavicle the size of a 50 cent piece Injection in the left arm Use warm compresses for 3-4 days and it went away
60 2021-03-21 lymph node swelling Swollen lymph nodes under arms and in groin, headache, pain at injection site, tiredness, fever, chi... Read more
Swollen lymph nodes under arms and in groin, headache, pain at injection site, tiredness, fever, chills, felt unwell
60 2021-03-21 lymph node swelling extreme fatigue, headache, nausea, muscle aches, joint pain, low grade fever, chills, swollen lymph ... Read more
extreme fatigue, headache, nausea, muscle aches, joint pain, low grade fever, chills, swollen lymph nodes in neck and under arm, treatment was motrin 600 mgs q6hrs from 2/18/21-02/22/21 returned to work on 02/23 lymph nodes still slightly enlarged as of today, 03/22/21
60 2021-03-21 lymph node swelling Rash and hives, itchy and swollen lymph node on right neck - appeared approximately 24 hours after s... Read more
Rash and hives, itchy and swollen lymph node on right neck - appeared approximately 24 hours after second dose of vaccine. Received one shot of steroid and prescribed a 6 day dose of oral steroid.
60 2021-03-21 oral herpes Loss of appetite morning after vaccine, headache, body aches, chills, face flushed. Fever started af... Read more
Loss of appetite morning after vaccine, headache, body aches, chills, face flushed. Fever started afternoon. 99.4. Took Tylenol but it gradually rose to 102.3. Took 3 hours for fever to go down. By 5:30 fever was gone & I was feeling better. Next day I felt great but by three days later I had a fever blister & very sore, dry and stuffy nose which lasted two weeks. And headache as well. I?m thinking because of stuffy nose. I did have Covid last March/April 2020 so I have heard that I would have side effects.
60 2021-03-21 swelling face About 45 minutes after the injection two large spots on the face had hives, moderate swelling beneat... Read more
About 45 minutes after the injection two large spots on the face had hives, moderate swelling beneath right side of lip, minor swelling beneath left side of lip. Took Zyrtec and symptoms went away.
60 2021-03-21 swelling face 3-22-21 11AM TC: PT STATES ON '3-19-21 7PM SHE HAD SWELLING OF HER TONGUE AND RT SIDE OF FACE AND NE... Read more
3-22-21 11AM TC: PT STATES ON '3-19-21 7PM SHE HAD SWELLING OF HER TONGUE AND RT SIDE OF FACE AND NECK; SHE CALLED HER PCP WHO HAD HER SUE HER EPI PEN - THE SWELLING RESOLVED. ON 3-20-21 SHE ALSO HAD A EARACHE, HEADACHE AND BLOODY NOSE. HAS TAKEN TYLENOL.'
60 2021-03-22 lymph node swelling Flu-like symptoms: headache, fatigue, dizziness, nausea, swollen lymph nodes, sore arm beginning th... Read more
Flu-like symptoms: headache, fatigue, dizziness, nausea, swollen lymph nodes, sore arm beginning the evening of injection. All symptoms, except sore arm, gone by morning. No treatment given.
60 2021-03-22 swelling face Swollen face; Swollen puffy eyelids and below eye; itchy rash on face,neck, and chest; This is a spo... Read more
Swollen face; Swollen puffy eyelids and below eye; itchy rash on face,neck, and chest; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 14Feb2021 at 12:30 at single dose for COVID-19 immunization. Medical history included allergies to dust mites, dogs, and corn; Hashimoto's thyroid; and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. She was not pregnant and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fluvoxamine maleate (LUVOX), thyroid (ARMOUR THYROID), and amlodipine. The facility where the most recent COVID-19 vaccine was administered was reported as other. The patient experienced swollen face, swollen puffy eyelids and below the eye, and itchy rash on face, neck, and chest on 14Feb2021 at 17:30. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was told to take ALLEGRA and PEPCID in the morning and CLARITIN AND PEPCID in the evening by the allergist. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were assessed as non-serious. Information on the lot/batch number has been requested.
60 2021-03-23 lymph node swelling, swelling Felt abnormal and went to bed. Woke up at 9:35am with 101.7 temperature and called into work to advi... Read more
Felt abnormal and went to bed. Woke up at 9:35am with 101.7 temperature and called into work to advise I will not be coming in. I went back to bed no food no medicine, Most information I read and was aware is that it would be better with sleep. Only to wake up at 8:30pm with a 102.7 had 500 mg acetaminophen went back to bed. Woke up Thursday morning at 9:45am fever free. Friday afternoon I noticed swelling on my left neck area. Just inside my left clavicle. I made a Dr appointment for Monday and Dr. found several Lymph nodes swollen as well as under my left arm pit area. Due to some chest pain she sent me for a chest x-ray.
60 2021-03-23 lymph node swelling Pain in left shoulder, radiating to axilla and elbow with painful swollen lymph node.
60 2021-03-23 lymph node swelling Swollen lymph nodes under the arms, joint pain throughout but highly concentrated on the right side ... Read more
Swollen lymph nodes under the arms, joint pain throughout but highly concentrated on the right side of body and arm
60 2021-03-23 swelling I was submitting my events daily on website and two days it tells me my session has expired and won'... Read more
I was submitting my events daily on website and two days it tells me my session has expired and won't let me report anything. On Sunday night, March 21st, I started with very painful joint and muscle aches with fatigue. The next morning I felt terrible and could barely function, I had a bought with diarrhea that lasted almost the entire day and had no energy. I developed a large lump on my left clavicle area that seemed to be filled with fluid. My knees I had replaced are still very painful today ( 7 days post vaccine). I phoned my Dr. yesterday and they told me to take 1000mg of Tylenol 3 times a day. I am doing this now for the second day with some relief. I feel this is very unusual to feel this way 7 days after the vaccine. On day 1-2 the only symptoms were a sore arm from the vaccine. Saturday was actually a good day with no symptoms, the other symptoms started on Sunday. I feel like my heartbeat is irregular also but my BP is good. I would like to be able to to report daily on v-safe like I was the first few days.
60 2021-03-25 lymph node swelling Initially, mild nausea, immediately (with 15 minutes of administration) . Resolved promptly within 3... Read more
Initially, mild nausea, immediately (with 15 minutes of administration) . Resolved promptly within 30 minutes of injection. Then, three hours after administration (at approx. 12.30 p.m.), the following symptoms in order of severity: 1. Severe tiredness/fatigue. Lasted 4 hours. Resolved when I took a half hour nap. 2. Sore throat. Still present at 10.30 pm. 3. Swollen lymph nodes (lymphadenopathy). Significant improvement after 4 hours from onset (3 hours after administration). However, still present at 10.30 p.m. 4. Feeling unwell/malaise. Resolved after I took a nap. 5. Dry eyes. I had to remove my contact lenses and put on eyeglasses when I got home at approx. 2pm. 6. Dry mouth. Unresolved, even with drinking a lot of water and tea. Symptoms were fairly severe. I had to leave work and go home to rest. I was unable to drive myself home.
60 2021-03-25 swelling face Patient reported facial swelling to the right cheek area and pain around the left eye socket. These... Read more
Patient reported facial swelling to the right cheek area and pain around the left eye socket. These symptoms appeared overnight, and the patient first noticed them upon awakening.
60 2021-03-25 swelling At 11:15 am of 3/26/21, after taking a shower, I was applying cream on my neck and I noticed a huge ... Read more
At 11:15 am of 3/26/21, after taking a shower, I was applying cream on my neck and I noticed a huge lump on the left side of my neck. Being an MD ( anesthesiologist), I examined the lump and felt like a size of a walnut in a shell. I immediately called my Primary and I went to his office. We discussed about my Covid vaccine. And he requested Chest X-ray. In the future, head and neck CT.
60 2021-03-27 lymph node swelling Flu like symptoms the next day. Most concerning was swollen lymph nodes under left armpit.
60 2021-03-27 lymph node swelling Tender and swollen left armpit.
60 2021-03-27 lymph node swelling 1. Some Swelling and redness at injection site 2. Some lymph node swelling and discomfort under righ... Read more
1. Some Swelling and redness at injection site 2. Some lymph node swelling and discomfort under right arm Outcome not known yet, swelling and redness seem to be lessoning.
60 2021-03-27 swelling face, lymph node swelling First dose I was fine,second dose I had reactions next day with face swelling lip swelling tired ne... Read more
First dose I was fine,second dose I had reactions next day with face swelling lip swelling tired next day swelling went down then I have big lymph node knots on both sides of neck with chills and fatigue. I am on third day and still have nodes on neck and tired with chills. My eyes fill little swollen also.
60 2021-03-28 lymph node swelling, swelling Swelling, redness and itching in arm pit of left arm and into lymph nodes. itching only when rubbed... Read more
Swelling, redness and itching in arm pit of left arm and into lymph nodes. itching only when rubbed.
60 2021-03-28 lymph node swelling Swollen lymph node under left arm.
60 2021-03-28 lymph node swelling Swollen Lymph Nodes, chills, headache, nauseous stomach, pain radiating in left boob & left back, an... Read more
Swollen Lymph Nodes, chills, headache, nauseous stomach, pain radiating in left boob & left back, and tireness
60 2021-03-29 lymph node swelling, lymph node pain Swollen lymph node under left armpit. Painful and burning feeling.
60 2021-03-29 lymph node swelling Swelling of the lymph node under left arm
60 2021-03-30 lymph node swelling After typical flu like reaction for 2- 3 days, symptoms of Epstein Barr- extreme exhaustion, muscle ... Read more
After typical flu like reaction for 2- 3 days, symptoms of Epstein Barr- extreme exhaustion, muscle weakness and aching, swollen glands and headache started about day 5 and have been severe times one month.
60 2021-03-30 lymph node swelling Moderate aches, fatigue and headache for 24 hours followed by lymph node inflammation in left armpit... Read more
Moderate aches, fatigue and headache for 24 hours followed by lymph node inflammation in left armpit which is ongoing, though improving slightly every day.
60 2021-03-31 lymph node swelling, lymph node pain Swollen, painful lymph node under arm pit. Fever. Chills. Achy.
60 2021-04-01 lymph node swelling she thought she was getting Bell's Palsy; Lymph nodes swelled; This a spontaneous report from a cont... Read more
she thought she was getting Bell's Palsy; Lymph nodes swelled; This a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 17:30 (at the age of 60years) as single dose for Covid-19 immunization. There was no medical history; no known allergies. The patient is not pregnant at the time of vaccination. Concomitant medications included colecalciferol (VITA D); ascorbic acid (VITAMIN C); fish oil; ubidecarenone (COQ10); magnesium; and zinc; all taken for an unspecified indication, start and stop date were not reported. 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 reported that her lymph nodes swelled on the same side where she received the shot. Also, the left side of her checks down to neck and shoulders felt weird, she can't quite explain the feeling; she thought she was getting Bell's Palsy which is one of the adverse reactions. She was alarmed as she was unaware of the swelling of the lymph nodes. The adverse events occurred on 19Mar2021 (16:30). There was no treatment received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering. Information about lot/batch number has been requested.
60 2021-04-01 lymph node swelling fever of 100.1 for 8-9 hrs. day after shot , swollen lymph nodes in right arm pit, slight headache, ... Read more
fever of 100.1 for 8-9 hrs. day after shot , swollen lymph nodes in right arm pit, slight headache, fatigue, slight cough, 2 days
60 2021-04-01 oral herpes Left arm- extremely sore shoulder to elbow, foggy headache, chills, fever blisters, sluggish.
60 2021-04-02 lymph node pain, lymph node swelling Severe joint pain (shoulders, elbows, hips, knees, ankles); chills; overall body aches. Lasted a lit... Read more
Severe joint pain (shoulders, elbows, hips, knees, ankles); chills; overall body aches. Lasted a little more than 24 hours, although the severity lessened on the 2nd day. Did not take any medicine to treat symptoms. Resolved by day 3. Enlarged, painful lymph node (right arm pit); lasted 5 days. Dull headache; lasted 3 days.
60 2021-04-02 peripheral swelling Swelling right underarm, ongoing; minor body ache throughout and felt like cold coming on, no fever,... Read more
Swelling right underarm, ongoing; minor body ache throughout and felt like cold coming on, no fever, 12 hours. Did not seek treatment.
60 2021-04-04 lymph node swelling Body between very hot and chills Lymph nodes swollen Extreme headache weak entire body pain
60 2021-04-04 swelling face Immediate taste of an antibiotic in mouth, numbing of lips and tongue within 3 minutes of vaccine. ... Read more
Immediate taste of an antibiotic in mouth, numbing of lips and tongue within 3 minutes of vaccine. Slight swelling on right side of face. Reported to primary physician and referred to neurologist. Second dose was canceled.
60 2021-04-04 white blood cell count increased Cold Feet, Nausea, Vomiting, Diarrhea/abdominal cramps. The diarrhea and abdominal cramps/stomachach... Read more
Cold Feet, Nausea, Vomiting, Diarrhea/abdominal cramps. The diarrhea and abdominal cramps/stomachache are still happening as I write this report today April 5, 2021.
60 2021-04-05 anaphylactic reaction Received first shot on 3/15/21. On 3/25/21, I developed a rash (hives) around 6:30-7pm. After dinner... Read more
Received first shot on 3/15/21. On 3/25/21, I developed a rash (hives) around 6:30-7pm. After dinner, around 7:30pm I noticed that my lips were swollen and the rash was spreading. Took one Benadryl and waited 1 hour. Condition worsened so left for ER around 8:45pm. Once there, I was diagnosed with an anaphylatic reaction. I was given Prednisone, Pepcid and Benadryl intervaneously. The Benadryl injection caused my throat to close for a few seconds. Things calmed down so we waited an hour to see if I was responding. There was not a lot of improvement so ER doctor decided to use Epinephrine (EP pen injection). After 2 hours of observation, I was set home to follow up with primary care physcian.
60 2021-04-06 peripheral swelling 3/10/21?first shot. Felt fine. 3/19/21?started to get rash on upper left arm?shot arm. 3-20-21?r... Read more
3/10/21?first shot. Felt fine. 3/19/21?started to get rash on upper left arm?shot arm. 3-20-21?rash spread to upper right arm and a few spots on my knees 3/23/21?blood draw. Platelets almost doubled since my last count three weeks prior. Increase anagrelide to two pills twice a day. 3/31/21?second dose. Shot again the left arm Felt fine that day. 4/1/21?felt tired. 4/2/21?really feel tired and skin feel tingly like a rash coming on. Had chills. By evening upper arms were red, sore, swollen, rash covered and warm to the touch. 4/3/21---Slept a lot of the day and still in a fair amount of pain. Upper arms and hands red, sore and swollen. Took an over the counter antihistamine Zyrtec, which helped with the swelling. 4/4/21?Continued with Zyrtec 4/5/21?Continued with the Zyrtec. Skin in my arms seems to be ?drying out? a bit and swelling down. 4/6/21?Arms and hand still red but swelling down.
60 2021-04-06 swelling pt says that her right arm became very sore. The muscles in her right knee became sore. Her knee s... Read more
pt says that her right arm became very sore. The muscles in her right knee became sore. Her knee seemed to have locked up. By the next day it became very painful and still. The pain is going up towards the thigh and then going down the calf muscle. Pt has taken Advil and used ice compressions for the pain. She says the pain and swelling seem to be less present today but is still there and will see an orthopedic doctor if she doesn't improve.
60 2021-04-07 anaphylactic reaction anaphylaxis with stridor and diffuse wheezes. No rash, GI symptoms. Received epinephrine, bronchodil... Read more
anaphylaxis with stridor and diffuse wheezes. No rash, GI symptoms. Received epinephrine, bronchodilators, IV steroids, histamine blockers, epinephrine drip. ICU admission
60 2021-04-07 swelling angioedema of the lip (resolved). Unclear if 2/2 vaccine or lisinopril
60 2021-04-07 axillary mass Large tennis ball size lump in L armpit
60 2021-04-07 lymph node swelling Swollen lymph node on the left side of the neck.
60 2021-04-07 oral herpes March 28: Bright red cheeks, extreme thirst, cold sores, severly chapped lips, clammy sweat (contin... Read more
March 28: Bright red cheeks, extreme thirst, cold sores, severly chapped lips, clammy sweat (continued through entire series of symptoms) March 31 - April 2: Fever, Chills, Excrutiating muscle and joint pain, nausea, severe headache. Unable to function, think clearly, or eat/drink. No vomiting April 2 - April 5: Severe upper stomach pain and burning/soreness under right side rib cage. Uncontrollable watery diahhrea. Unable to eat the first two days of this. Able to drink some. April 5 to current: Still fighting the diahhrea but pain stopped. Have been on the BRAT diet since April 4th. Began taking a prescription from doctor to help with diahhrea on April 8. Still experiencing dizzyness, lack of clarity.
60 2021-04-07 peripheral swelling Side of right foot got very red and swollen, then turned to large bruise covering little toe, and pa... Read more
Side of right foot got very red and swollen, then turned to large bruise covering little toe, and part way down foot. Next bruised spread out.
60 2021-04-09 anaphylactic reaction Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor; ... Read more
Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor; Anaphylaxis; chest hurt to breathe; Itching in my arms and chest in the evening.; rash; This is a spontaneous report from a contactable healthcare professional (patient). A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Left arm on 15Mar2021 at 17:00 (Batch/Lot Number: EP8534) as SINGLE DOSE for covid-19 immunisation. Medical history included Only occasional migraines. Never anything like this and known allergies: Some grasses. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported; betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES) taken for an unspecified indication, start and stop date were not reported. On 18Mar2021, at 8pm, the patient reported that "3 days after 2nd shot I started itching in my arms and chest in the evening. Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor. My rash was worse and spreading and chest hurt to breathe and I had bumps on head so we called # and nurse and my husband drove me to (Name). They gave me an IV and epinephrine shot and Pepcid and did CT scan of head and blood work. Diagnosed Anaphylaxis. They sent me home a couple hours later with prescription for Epi pens Zyrtec and Famotidine. Over the course of Friday my rash/hives got worse and spread over my body and my lips /mouth started to swell. I called the nurse who suggested I come back in and they checked by throat to ensure it wasn't closing up and gave me ibuprofen and Benadryl and sent me home. Rash/hives worse and spread all over body and face when I woke up Saturday morning (today). Plan to see specialist Sunday or Monday." The outcome of the events was not recovered. The patient was not tested for COVID-19 after vaccination.
60 2021-04-09 bursitis Pfizer-BioNTech COVID-19 Vaccine EUA I had normal pain at the injection site after the shot, which ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA I had normal pain at the injection site after the shot, which went away after a couple of days. A few days later a different part of that upper arm and shoulder became painful to move certain ways. I saw my primary care physician and he said the shot must have nicked the bursa under the muscle. He diagnosed bursitis and prescribed diclofenac gel.
60 2021-04-09 lymph node swelling Left shoulder blade pain, headache and swollen lymph node in left arm pit
60 2021-04-11 lymph node swelling u1st Pfizer vaccine on 3/17/21 the next day I only has pain with swollen area in left arm around sho... Read more
u1st Pfizer vaccine on 3/17/21 the next day I only has pain with swollen area in left arm around shot location. My 2nd Pfizer vaccine on 4/7/21 the next day around 4pm I started all the symptoms until chills, aches and pains, fever, and nausea, This was severe Thursday evening and most of Friday. Friday night I had swollen lymph nodes in the armpit and near the collarbone on my shot arm. This was very uncomfortable. Saturday the chills, aches and pains, fever, and nausea started to go away. Sunday mostly swollen lymph nodes and aches and pain in joints. Sunday night swollen lymph nodes stared to go down. Monday am still a bit tired but feeling better
60 2021-04-11 lymph node swelling Slightly swollen lymph node on left side and recurring but not constant earache.
60 2021-04-11 swollen extremities Swelling and pain under left armpit
60 2021-04-11 peripheral swelling 4/7/21. Sweating profusely,no fever. 4/8/21 .Swollen left upper arm (2× it's size).Intense itching... Read more
4/7/21. Sweating profusely,no fever. 4/8/21 .Swollen left upper arm (2× it's size).Intense itching entire left arm for 24 hours
60 2021-04-11 peripheral swelling My arm was sore immediately. As the hours progressed after the shot, my left upper arm became very ... Read more
My arm was sore immediately. As the hours progressed after the shot, my left upper arm became very swollen, hard, and painful enough to wake me in the middle of the night. The hard lump was as big & wide as my right hand and began 2 inches above my elbow up to the place of injection. When my morning alarm went off, I was very fuzzy and extremely weak. I was unable to go to work or remember a lock combination I use every day. My energy began to return the next day enough to work a half day but returned to bed for the afternoon. The tiredness was all but gone by 8:30 pm. Reaction began Sunday morning and was gone by Tuesday night.
60 2021-04-11 peripheral swelling Headaches, body-aches, intermittent fever, irritated eyes, swollen arm.
60 2021-04-11 swelling face facial swelling and eye swelling lasting over 4 weeks,short of breath,
60 2021-04-12 axillary mass Painful, swollen lump in left armpit.
60 2021-04-12 lymph node swelling Swelling in left armpit, same side as injection. Lasted about 6 days.
60 2021-04-12 lymph node swelling The usual sore muscle. VERY swollen lymph nodes.
60 2021-04-13 lymph node swelling Swollen Lymph Nodes in Left underarm
60 2021-04-14 swollen extremities Swelling right arm pit, very large size of a lemon, severe pain, resolving with warm compresses afte... Read more
Swelling right arm pit, very large size of a lemon, severe pain, resolving with warm compresses after 4 days.As of 4/15/2021 slight persistent swelling. Severe chills, no fever 4/8/2021 thru 4/9/2021, diminishing over time. Severe headaches, starting 4/9/2021, lasting for 6-8 hours, refractive to acetomenaphin, ibuprophen. Continuing through 4/14/2021. Suspected gallbladder involvement.
60 2021-04-16 peripheral swelling experienced extreme pain on my inner thigh on my left leg; It was hot to the touch, very red and swo... Read more
experienced extreme pain on my inner thigh on my left leg; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; difficulties to sleep and walk; difficulties to sleep and walk; Superficial Thrombophlebitis; This is a spontaneous report from a contactable consumer (patient). A 61 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL9263, expiry date not reported), at the age of 60 years old, via an unspecified route of administration, administered in left arm on 02Feb2021 09:00 at a single dose for covid-19 immunisation. The patient then received the second dose of covid-19 immunisation on 23Feb2021 08:00 AM (lot EN6200), via an unspecified route of administration, administered in the left arm. Medical history included rheumatoid arthritis and multiple sclerosis, both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination and the events. The patient no covid prior to vaccination. The patient's concomitant medications were not reported. The patient was not tested for covid post vaccination. Soon after COVID-19 vaccination, on 21Feb2021, patient experienced extreme pain on inner thigh on left leg. It was hot to the touch, very red and swollen causing difficulties to sleep and walk. Patient then saw a vascular doctor for the pain on 16Mar2021 and was advised that patient have superficial thrombophlebitis (since 21Feb2021) and was prescribed to take Xarelto 15 mg for two weeks. Therapeutic measures were taken as a result of the events reported which included Xarelto 15 mg and had a venous ultrasound of area on an unknown date (unknown results). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events reported was recovering.
60 2021-04-17 axillary mass, lymph node pain bad case of jet lag; glands under my arms got very sore; lumps under my arms; This is a spontaneous ... Read more
bad case of jet lag; glands under my arms got very sore; lumps under my arms; This is a spontaneous report from a contactable consumer (patient). A 60-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 26Mar2021 14:00 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation at a workplace clinic. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included losartan and sertraline hydrochloride (ZOLOFT). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 for COVID-19 immunization. The patient also previously took codeine and experienced allergies. On 28Mar2021 08:00, the patient felt like a very very bad case of jet lag. Also, the glands under her arms got very sore and felt like there were lumps under her arms. The events were not treated. The outcome of the events was recovering.
60 2021-04-17 lymph node pain tenderness in lymph nodes under the arm of the arm that received the shot; This is a spontaneous rep... Read more
tenderness in lymph nodes under the arm of the arm that received the shot; This is a spontaneous report from a contactable consumer reported for herself. A 60-year-old female patient received second dose of bnt162b2 (Lot Number: ER8732) via an unspecified route of administration in left arm on 29Mar2021 13:15 as single dose for covid-19 immunisation. Medical history included asthma, NAFLD (Fatty liver), high blood pressure, high cholesterol. Patient was not diagnosed with COVID-19 prior to vaccination. Patient not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, with unspecified medications the patient received within 2 weeks of vaccination. Patient received first dose of bnt162b2 (lot number: EN6205) on an unspecified date in Mar2020 10:15 PM in left arm. On 30Mar2021 09:00 AM, patient experienced tenderness in lymph nodes under the arm of the arm that received the shot. The event outcome was recovering. No treatment received. Patient had not been tested for COVID-19 since the vaccination. No follow-up attempts are needed. No further information is expected.
60 2021-04-18 lymph node swelling Shingles-left shoulder blade and left breast (vaccine in left arm); began two days after vaccine wit... Read more
Shingles-left shoulder blade and left breast (vaccine in left arm); began two days after vaccine with tingling on shoulder blade, then red rash, then painful blisters; stinging/stabbing pain; inability to sleep due to discomfort Lymphadenopathy-swelling in my left breast and chest; much discomfort
60 2021-04-18 lymph node swelling Left axillary lymph nodes swollen to size of a deck of cards
60 2021-04-18 lymph node swelling Following my first Covid 19 Pfizer vaccine 03/11/21: **Note, I went through 1 1/2 days dull ache i... Read more
Following my first Covid 19 Pfizer vaccine 03/11/21: **Note, I went through 1 1/2 days dull ache in arm no concerns > days 2--5 went through a HYPER-WELL (no age aches, prior-hurt finger didn't ache, energy, ladies room habits back to what I reported to daughter "age 20!" for these four days, amazing, enjoyable, then > day 6 very early am woke up with swollen neck lymph nodes half-palm sized rocks on neck, breathing difficulties (lungs not neck), bad dull intrusive headache (different pain from Migraine, or low-hydration pain), cough dry and have called this my HYPER-CRASH because I could barely walk, backward C-shape abdomen hurt (dull ache big always + frequent stabbing pains from below bra bottom line to left abdomen down side then curving to my right across bottom abdomen at both leg-attaches-to-abdomen locations. Difficulty breathing, pain, extreme swelling over upper abdomen when I even drank water to swallow morning Hydrochlorothiazide pill and would stay swollen for 4-8 hours with continued surprise to me gulps of air throughout period, weak, nausea but not vomiting, dizzy, unable to walk more than a few steps at a time, fever taken and wavered from 95 to 99 degrees (my usual body registered 97.8 degrees) but never over 99 degrees, and only over 97.8 degrees perhaps three times very little above it and only for a few hours. >>I went to Urgent Care in person no better at all on 3/24/21/roughly day 12 after vaccine shot 3/11/21 (Urgent Care) which took blood and urine tests determining roaring infection and blood in tests and a CT CONTRAST scan should be ordered by my PCP asap at appt PCP already scheduled 3/26/21 but she couldn't order CONTRAST version the PCP would need to and she prescribed three antibiotics to take over next 2 weeks >> I went to PCP 3/26/21/day 14 after vaccine shot and he ordered CT Scan but insurance required pre-auth and they refused it at first so PCP referred me to GI SPECIALIST who again referred me for CT CONTRAST test, which I did have on Friday afternoon 4/16/21 (Clinic), and I await the results today 4/19/21. Today I continue to have pain abdomen, though softer and throbbing, same C-shaped region, HUGE issue even drinking water with Hydrochlorothiazide pill only for many hours as abdomen swells at bottom bra-line center in a palm size mound for hours, and back hurts badly, solid headache which may be only right side of head more than left but I am taking nothing for any symptoms afraid of GI issue. NOTING AGAIN: Yes I was diagnosed roughly 2015 with a single incidence of diverticulitis/osis by GI SPECIALIST in Town and went through series of Colonoscopies and tests, but tests only determined incidental few polyps removed over all tests and no incidents at all since that. Knowing what I know of my body and health, the trigger seemed to be the first shot of Covid 19 Pfizer vaccination which remarkably seemed to react first with a few days of better health than I have had for decades (eating, moving, energy etc. for my age), where after days of extreme great health and energy (where I went nowhere, and still did not push myself much) my body then crashed to unable to move much or even breath normally for many days after and with a multi-level infection in my gut that needed three antibiotics and after those I still hurt in the same locations. I cannot confidently rule out the Vaccine as the cause, and what I know of my body suggests in fact some "overdrive" function in my system was triggered and then caused the crash that resulted in infection and that continues to interfere with my walking, eating, moving, breathing, and even drinking a small glass of water today. Final note: PCP confirmed I should take the second Vaccine Pfizer shot, which I did on 4/1/21 - same site, Lot #EW0150, after which second vaccine shot I had the same two days of dull arm pain, and I continued to finish the antibiotics until finished (but pain though softer continues to today). I did not experience a #-Days HYPER-WELL episode then HYPER-CRASH after this second vaccine shot, only the arm ache, but throughout was still very unwell (breathing, pain, no activity, weak, unable to eat, swelling, headache, cough intermittent, back hurts, etc.) throughout, and same to this day 4/19/21 as I await CT CONTRAST results. I felt compelled to share I feel this was triggered by the first Vaccine shot, and would not have happened had I not had the Vaccine shot. Thank you.
60 2021-04-19 peripheral swelling Sat (4/17): severe chills for two hours starting at 11:55 pm Sun (4/18): woke and could not walk acr... Read more
Sat (4/17): severe chills for two hours starting at 11:55 pm Sun (4/18): woke and could not walk across the room without falling down due to dizziness, was nauseated, strong headache, fever of 102 all day, bedridden Mon (4/19): Fever was reduced but nausea, headache still persisted all day, continued chills. Right middle finger began to swell and turn purple Tues (4/20): Lost feeling/sensation in right middle finger, head feels off, nausea still persists, stomach pains. Called doctor and had televisit with nurse practitioner
60 2021-04-21 lymph node swelling Fever, chills ,sore arm and lymph nodes swollen in arm pit of left arm
60 2021-04-21 oral herpes, swelling face Red rash mostly under right eye, but small place under left eye as well. Does not hurt or itch, just... Read more
Red rash mostly under right eye, but small place under left eye as well. Does not hurt or itch, just swollen and red. Also developed a fever blister/cold sore on upper lip at the same time. It's been about 23 days since first shot and I still have the rash under my right eye, but cold sore is gone. Did not see doctor. Treated cold sore with Blistex and just put vaseline on rash at night.
60 2021-04-21 oral herpes Cold sores around mouth and chin. Accompanied by severe nausea. They are still breaking out so unsu... Read more
Cold sores around mouth and chin. Accompanied by severe nausea. They are still breaking out so unsure how bad yet or if hospital is needed.
60 2021-04-21 peripheral swelling On 4/10/21 I had fever and severe chills. On 4/11/21 the fever broke. I was fine but weak. On the ni... Read more
On 4/10/21 I had fever and severe chills. On 4/11/21 the fever broke. I was fine but weak. On the night of 4/11/21 (9:00pm) fever returned. I took advil and went to sleep. On 4/12/21 I woke up with my arm very swollen and it was hot to touch. By the afternoon I was worse and the area was turning red so I went to the Urgent care and diagnosed with Cellulitis (which I have never had and didn't understand at first what this was about). I was treated and returned to my regular Doctor for follow up. I still have this thing and although it's better it's not gone as of this report and it is causing me distress in typing, cleaning and so on.
60 2021-04-23 lymph node swelling 6 hours after the injection, i developed lymph node swelling on my collar bone approx. 3 in x 3in ar... Read more
6 hours after the injection, i developed lymph node swelling on my collar bone approx. 3 in x 3in area, headache, watery ices and sneezing that lasted 48hours. As of today, April 24th the swollen lymph node is still present
60 2021-04-23 lymph node swelling Swollen lymph nodes under right arm 29 to 30 hours after receiving vaccination. Still experiencing s... Read more
Swollen lymph nodes under right arm 29 to 30 hours after receiving vaccination. Still experiencing swollen lymph nodes 4 days later.
60 2021-04-23 peripheral swelling Day after shot (Saturday 10 April) - nausea, headache, 101.5 fever, body aches, arm soreness, tired... Read more
Day after shot (Saturday 10 April) - nausea, headache, 101.5 fever, body aches, arm soreness, tiredness 2nd day after shot (Sunday 11 April) - slight headache, tiredness, red rash around injection site and itching. My arm was also swollen and more sensitive to touch than movement. The itching wasn't bad enough that I needed to take any meds. I just wanted to report this adverse reaction to the second shot.
60 2021-04-24 lymphatic obstruction, peripheral swelling Swelling lower left arm and hand. Intensified to include entire left arm. Deep bruised ache feeling.... Read more
Swelling lower left arm and hand. Intensified to include entire left arm. Deep bruised ache feeling. Heaviness. Could not fit arm through sleeve. Became difficult to use hand due to swelling. Due to swelling now have carpal tunnel in left hand with numbness & painful tingling.
60 2021-04-24 white blood cell count increased 3/19/21: patient is a 60yo female who presented with complains of facial droop. The sister reports t... Read more
3/19/21: patient is a 60yo female who presented with complains of facial droop. The sister reports the patient complained about headache in the left temporal area around 8-9pm, reports having the same pain throughout the week but today was stronger, and the sister noticed she had facial droop and was unable to open her left eye. The patient also reports abdominal discomfort the the epigastric region and LUQ that started today and was associated with nausea. She denies diarrhea or fever. Of note patient reports having Covid Pfeizer vaccine yesterday and 5 minutes later being were unable to speak with edema in her lips and tongue, associated with SOB. She was taken to a ER, was given epipen, albuterol, benadril, prednisone and was discharged home at night with improvement on her symptoms. Patient discharge note on 3/22/21: Admitted for facial paresthesias in setting of arnold-chiari malformation, HTN, HLD, after covid vaccine, neuro work up neg, discharged home on 3/22/21.
60 2021-04-25 swelling face Adverse event: Pt received first dose Pfizer COVID-19 vaccine on 4/13 at approximately noon. She st... Read more
Adverse event: Pt received first dose Pfizer COVID-19 vaccine on 4/13 at approximately noon. She states later that evening, approximately 6pm, she noticed her right eyebrow and corner of mouth "looked funny", as they did not raise in symmetry with the left side of her face. She denied any other noticeable deficits in the head/neck, upper and lower extremities. Treatment: none Outcome: patient reached out to our facility and asked whether or not she should get the second dose. I described the risk / benefit ratio of not receiving the second dose. Pt states she would research the topic further on her own before making a decision. I advised the patient may report the incident to V-safe as well.
60 2021-04-26 lymph node swelling I had all this pain at the injection side; tired; headache; chill; throat pain; fever; nausea; swoll... Read more
I had all this pain at the injection side; tired; headache; chill; throat pain; fever; nausea; swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/expiration date: unknown) via an unspecified route of administration on 23Feb2021 (at age of 60 years) at single dose for COVID-19 immunization. Patient relevant medical history included chronic obstructive pulmonary disease (COPD). Patient concomitant medications were not reported. After receiving covid-19 vaccine patient started running really high temperature and pain at the vaccination side, really tired, headache, chill, throat pain, fever, nausea, Patient said swollen lymph nodes, throat has been sore on unspecified date. Patient stated that run temperature but took Tylenol and it took it down it was high, but I still have the soreness. Patient also mentioned having COVID 19 infection months ago. Treatment received for events was unknown. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
60 2021-04-26 lymph node swelling Multiple swollen lymph nodes under both underarms and right groin. Also noticed flare up of arthri... Read more
Multiple swollen lymph nodes under both underarms and right groin. Also noticed flare up of arthritic pain in left knee
60 2021-04-27 lymph node swelling After the first dose, developed a skin rash behind the knee. With the second dose I have a skin rash... Read more
After the first dose, developed a skin rash behind the knee. With the second dose I have a skin rash in multiple places and an inflamed lymph gland under my right arm.
60 2021-04-28 white blood cell count increased 50 year old female had 1st Covid Pfizer vaccine on 3/18/21 and second dose on 4/14/21. Developed muc... Read more
50 year old female had 1st Covid Pfizer vaccine on 3/18/21 and second dose on 4/14/21. Developed mucosal bleed in tongue and lips. Went to the ER on 4/25/21 and found to have WBC 8.1, Hb 10.2, Plt 10K. Peripheral smear showed thrombocytopenia, no platelet aggregates. WBCs were normal. RBCs showed mild normochromic, normocytic anemia. Patient was started on Prednisone 60mg x 3 days. PLT increased to 75K on 4/27/21 and patient was discharged on 4/27. She was seen in the outpatient clinic on 4/29/21, on Prednisone 50mg . Her Prednisone taper is planned at 50mg x 3d, 40mg x 3d, 30mg x 3 days, 20mg x 4 days, 10mg qd then office visit scheduled again to monitor response. Bleeding spot from the tongue, and lips resolved.
60 2021-04-29 peripheral swelling One hour post vaccine - severe SOB lasting maybe 30 min, followed by right leg/ankle/foot swelling -... Read more
One hour post vaccine - severe SOB lasting maybe 30 min, followed by right leg/ankle/foot swelling - not painful, but would not resolve with furosemide 40 mg. Severe Swelling persisted for over 2 weeks before eventually resolving. My concern is I?m due to get #2 vaccine 5/2/21 and am worried about possible blood clot as I have a past history of a blood clot (left leg) 14 years ago.
60 2021-04-30 anaphylactic reaction, swelling face Caller states the patient had an anaphylactic reaction twice that caused her to go to the emergency ... Read more
Caller states the patient had an anaphylactic reaction twice that caused her to go to the emergency room; couldn't swallow; right side of the patient's face swelled up and her lips were numb; right side of the patient's face swelled up and her lips were numb; face numb; hands itching; tongue had swelled up; voice was scratchy; This is a spontaneous report from a contactable consumer, Reporter's sister via Pfizer-sponsored. A 60-year-old female patient received the second dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Ex-piry Date: Unknown) via an unspecified route of administration on 01Mar2021 on an unknown ana-tomical location as a single dose for COVID-19 immunization. Caller provided that her sister got the vaccine for COVID Prevention and because the patient has a handicapped, bedridden husband who has MS and is immune compromised, and it was to help prevent him from getting sick. Caller reported that the patient received the product during the daytime, all the women at the patient's job, which was home health payroll, everyone left to get the vaccine during work hours, like in the AM at around lunch time. Patient's medical history and concomitant medications were unknown. Patient has not received any prior vaccinations within 4 weeks. Patient had no other vaccines on the same day as the suspect product. Patient received first dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Expiry Date: Unknown) on 08Feb2021 with no reaction. She worked for a health agency and the whole office went and got it. Caller provided that her sister had a reaction the first time, on 03Apr2021, where her sister woke up with itching started in her hands and ended up migrating to her whole body. By morning patient's tongue had swelled up, couldn't swallow and her voice was scratchy, like the caller couldn't understand her sister's speech well. Caller provided that her sister went to the ER and said there was a whole team giving her urgent care, medication, and such. Caller reported that her sister said the ER didn't find anything in her bloodwork, and the caller did not think the patient was being treated for any other medical conditions, and caller did not think her sister is on any medications, but caller said to not quote her on that. Caller knew her sister had a weight problem, but she did not know if her sister needed blood pressure medication or anything. Caller reported her sister said that the bloodwork from the ER did not find any-thing, and the patient was not admitted to the hospital. Caller reported that at this time, her sister's adverse events were no longer ongoing as her sister was given Steroids, like Prednisone, Benadryl and Famotidine, and she took those products as recommended by the doctor. Caller did not know the end date of her sister's events; all she knew was that the reaction initially started on 03Apr2021. Caller stated that her sister was allergic to nothing, and she has never had incidences of itching like that, where the itching was so bad that she was stripping down and the patient's daughter was patting the patient down with witch hazel. Caller stated that ER released the patient and gave her some medications and such. Caller stated that a day or so later, there was a second round of reaction: the right side of the patient's face swelled up and numb and her lips were numb, like when people have a dental procedure. Lips were numb for a while. Upon completion of the medications she was given, the reactions stopped. Patient regularly saw the family doctor. She would go back to see her Doctor on Thursday. HCP Information was unknown to the caller, but caller stated that her sister had been recommended to go to her PCP and get an Epi Pen. Caller stated that knock on wood, so far, her sister was holding her own, and it had not happened again. Caller stated that she was reporting the data that her sister gave to her after having the Pfizer vaccination. Caller stated the patient had an anaphylactic reaction twice that caused her to go to the emergency room. No relevant tests were done. Caller stated that she had the dates that she had her shots and where she had her shot at. Caller stated somebody called and reported it already. Caller stated she was trying to press three but never could figure out which prompts was. Caller stated they said if she called this number, they would tell her at the medical information department if this occurrence has happened to other people, like statistics. Caller stated they tried to call this number, but it was too long of a wait. Caller stated that she did not have the vaccination card, she never asked for them. Caller does not have card with her at time of call for LOT, NDC, Expiry date. Caller stated that she knew that all the COVID vaccines are just in the Emergency Use Authorization stage and in clinical trials, but caller really thought that all manufacturers should be advertising that they would like feedback from patients. Caller has not heard anything from any of the manufacturers saying that people are welcome to reach out and report side effects. Caller states that she only knew to call because she used to be a Home Health Worker, and she thought this is an important data. Caller has never seen on any of her 19 TV channels about calling to report. Caller stated that the girl who first answered her call, read a clinical data sheet about joint pain being seen in 23% of patient's and not knowing a percentage for anaphylactic reactions, caller was wondering if this was true. Caller verified that she just wanted to ask basically that patient was not alone, if other people might have had that happen too. Caller stated that she tried to call, and it would ask another question and it would say press 1 or 2, then it would ask other questions and it would say press 1 or 2, she never got an option 3. Caller asked: how much percentage, has anyone reported this side effects weeks after the second dose. Caller was wondering if this reaction could have been from the vaccine. Investigation Assessment: No. The outcome of the events were unknown. Information on the lot/batch number has been requested.
60 2021-04-30 anaphylactic reaction Anaphylactic reaction; it started like a flushed feeling; She felt woozy; she still feels a little t... Read more
Anaphylactic reaction; it started like a flushed feeling; She felt woozy; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she is just a little uncomfortable, just a little today, not too bad; She adds that she is having a hard time focusing; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8731 and expiry date unknown, Solution for injection), via an unknown route on 12Apr2021 at 15:05 (at the age of 60-years-old) at single dose on left arm for COVID-19 immunization. Relevant medical history included allergies, asthma, she had anaphylaxis in the past to allergies. (Unspecified allergens). The patient added that she had issues for about a year before her surgeon had to do a surgery on her throat. She added she was fortunate because her thyroid was in her airways 14 years ago and her body exploded with allergies and her throat closed a lot. When the doctor did the surgery, the doctor opened her throat up more so that if she had another anaphylaxis it would not result in death. Concomitant medications was not reported. On the same date, after the vaccination the patient had anaphylactic reaction. She stated that happened 62 minutes, it might have been 64 minutes and also stated a few minutes after 60 minutes. The vaccination facility released her after 30 minutes at 15:35 and when she realized something was happening it was 16:10 when the patient realized what it was that she was experiencing. The vaccine facility held onto her for 30 minutes, so she got the vaccine around 15:05 and they watched her for 30 minutes. She believed it was around 65 minutes later that she started noticing something was happening. The patient started like a flushed feeling. She does not know to describe it, it was like she had a drink or something like she felt flush or something over her system like a wave or something. It was like a strong drink or something. She does not drink a lot but it was like woohooo, a wave of something, and then she felt woozy. It was not too bad at first, she was at a bank drive through and she was not driving. The patient was going to pick something up so she stopped for 5 to 10 minutes. She was on the phone with a friend. She felt woozy. The patient asked her husband to buy diphenhydramine (Benadryl). Her husband called back when she got done at the bank, and she was only 10 minutes from her house. The patient had her EpiPen with her. The patient was feeling better and she still feels a little tight in her throat and the way she explained it yesterday was that it was like someone had their finger down her throat, it was uncomfortable. She was just a little uncomfortable, just a little today, not too bad. She added that she was having a hard time focusing. Today, the patient felt tight, scratchy, and hoarse. It was not like it was last night. The patient did not receive any treatment for the events. Outcome of the events were unknown. Description of Product Complaint: Description of complaint: Consumer reporting an AE for the Pfizer COVID 19 vaccine mentions that they told her not to take the flu vaccine because she would get sick. Her flu symptoms would go on for 2-3 months. If she got the flu shot in September or October, she would not feel well through Christmas. Caller adds that she never got the flu again when she stopped the vaccine. Caller does not know manufacturer, NDC, lot or expiration date for the flu vaccine she had that made her sick Caller does not have any information about the Benadryl - and she does not have the bottle that she took that made her sleepy because she added that the only bottle she had was the one that her husband bought yesterday and it was not opened and she had not taken it. Caller added that she had not taken Benadryl in 14 years since before her surgery. Caller adds it might have been 15 years, she would have to remember that. AE identified after call completed. No NDC, lot or expiration date provided for Benadryl caller took 14 to 15 years ago. Follow-up attempts completed. No further information is expected.
60 2021-04-30 anaphylactic reaction anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both,... Read more
anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.
60 2021-04-30 lymph node pain Injection site arm pain for 5 days, followed by pain in left neck and left collarbone lymph node app... Read more
Injection site arm pain for 5 days, followed by pain in left neck and left collarbone lymph node approximately 1 week after injection. 10 days after injection pain in collarbone increased, area tender and discomfort when bending forward and shrugging.
60 2021-04-30 swelling face C/o facial fullness, jaw/facial heaviness, dizziness, and slight speech slurring 5 mins after vaccin... Read more
C/o facial fullness, jaw/facial heaviness, dizziness, and slight speech slurring 5 mins after vaccine. No CP, SOB, dyspnea, blurry vision, HA, redness, swelling, rash noted. A&O x 4, able to speak full sentences. VS stable: 88. 97%, 144/86, BS: 116. EKG: NSR. Neuro exam normal, muscle strength intact, facial symmetry, no facial droop noted. Advised pt to transport to hospital but pt refused transport. Observed for total 45 mins.
60 2021-05-01 swelling face C/O FACIAL FULLNESS, HEAVINESS, JAW, HEAVINESS, DIZZINESS, SLIGHT SPEECH SLURRING 5 MIN AFTER VACCIN... Read more
C/O FACIAL FULLNESS, HEAVINESS, JAW, HEAVINESS, DIZZINESS, SLIGHT SPEECH SLURRING 5 MIN AFTER VACCINE
60 2021-05-02 c-reactive protein increased 4/9/21 Pt had URI symptoms. She was seen at a Minute Clinic. Tested negative for Sars-Co-V-2 4/12 Ha... Read more
4/9/21 Pt had URI symptoms. She was seen at a Minute Clinic. Tested negative for Sars-Co-V-2 4/12 Had continued symptoms. Test positive for SARS-CoV-2 4/15 Treated with mAB 4/17 Presented to ED w/nausea and decreased appetite. Vitals stable. No hypoxemia. +electrolyte imbalance K+ was 2.9. Given IFV and K repletion and discharged to home 4/19 Started on Zpack and Decadron as outpt 4/21 Returned to ED with increasing SOB and reported home pulse ox 75-82% w/ exertion. In ED, sats in low 90's. Tachypnea with RR24-28. CTA + for PNA and new PE Discharge summary : Pulmonary embolus Likely secondary to COVID-19 infection; HRT possibly contributing Chest CTA showed a small subsegmental pulmonary embolus in the left lower lobe. Flattening of the interventricular septum possibly indicating acute right heart strain Lovenox 1 mg/kg twice daily in the hospital and transitioned to Eliquis at discharge Patient currently on estrogen placement therapy-discontinued Covid-19 Virus Infection Date of onset of symptoms: 4/9/2021 Symptoms present on admission: Productive cough, dyspnea Date of covid positive test: 4/12/2021 Vaccination status: First dose given on 3/31/2021 Special isolation anticipated end date: 4/22/2021 if symptomatically improving Imaging: Chest CTA with interval worsening of diffuse interstitial infiltrates Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: Continue oral Decadron 6 mg daily Consultants following: None Inflammatory markers: LDH 306, ferritin 507, CRP 54.3 and D-dimer 2.07 Disharged on codeine cough syrup and Tessalon for persistent cough
60 2021-05-02 lymph node swelling, lymph node pain Swelling of lymph nodes in left breast, armpit. Painful to touch, and unable put arm down at side fo... Read more
Swelling of lymph nodes in left breast, armpit. Painful to touch, and unable put arm down at side for two days. This did not start until about 2 days after second vaccination. I had no adverse reactions from 1st vaccine. No other symptoms. Went away after 2-3 days of swelling. I took 2 Aleve twice a day for pain. Now it is fine.
60 2021-05-03 lymph node swelling Left arm pain starting on 4/26/21 and then redness at the site of injection started that spread outw... Read more
Left arm pain starting on 4/26/21 and then redness at the site of injection started that spread outward from there. Was raised, warm, and red. On 5/4/21 slightly pink in color but still mildly warm to the touch and mildly swollen. Still painful on the left deltoid when lifting arm because of the mild site swelling that remains. Swollen lymph node in the left armpit on 4/24 and 4/25 but then resolved.
60 2021-05-03 lymph node swelling swollen node, extreme pain in my left armpit, some pressure in my chest as a result of the pain in a... Read more
swollen node, extreme pain in my left armpit, some pressure in my chest as a result of the pain in armpit area
60 2021-05-03 swelling I woke up 4/26/21 with what looked like 2 bug bites on my left cheek. By morning of 4/27/21, it was... Read more
I woke up 4/26/21 with what looked like 2 bug bites on my left cheek. By morning of 4/27/21, it was completely swollen. I experienced itching, pain & vibrating pulses in this area. The swelling enlarged over the next several days. On 4/22/21, I had gone to my annual dermatology appt at Derm. I had to have 2 spots frozen off my face. One on my left cheek & one on my forehead. Since the swelling was occurring near the area I had frozen on my left cheek, I called Dr at Derm & was seen by them for a wound check follow up on 4/28/21. She did not know what it was but did not think it was related to her procedure. She took a culture & had it tested. Her best guess was that it was either an infection or Shingles. Since the results of the culture was going to take several days, she gave me a RX for ValACYclovir. This was just in case it was shingles. Even with this medication, the swelling, itching, burning & pulsating continued. On 5/4/21, I woke up & noticed a significant reduction in the swelling on my left cheek. I also received a follow up message from Dr that the results showed negative for Shingles. However, they have no idea what caused the issue on my left cheek. She recommended that I notify CDC as it may or may not be related to the Covid shot.
60 2021-05-04 peripheral swelling blood pressure (BP) went over 269/149, it made my blood pressure go up.; left side of middle back ha... Read more
blood pressure (BP) went over 269/149, it made my blood pressure go up.; left side of middle back had some excruciating pain; Nauseous; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I got a mark on my arm, my arm started swelling; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0164/expiration date: 30Jun2021), via an unspecified route of administration, on 16Mar2021 (at the age of 60 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 EN6208/expiration date: not provided), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced a headache. Relevant ongoing medical history included Diabetes Type II from about 5 years ago in 2016, fibromyalgia diagnosed about 6 years ago in 2015, and high blood pressure. Concomitant medication included gabapentin from an unspecified date at 600mg 3x/day for fibromyalgia, empagliflozin (JARDIANCE) from an unspecified date at 10mg 1x/day for Diabetes Type II, clonidine from an unspecified date at 30 mg, 2x/day for high blood pressure and labetalol from an unspecified date at 200 mg, 2x/day for high blood pressure. On an unspecified date in Mar2021, the patient experienced her blood pressure (BP) went over 269/149, it made my blood pressure go up, which required hospitalization overnight. Also on an unspecified date in Mar2021, the patient experienced a mark on her arm, and her arm started swelling. On 16Mar2021, the patient experienced major body ache, described as it started hurting the minute she put it in her arm, excruciating pain and pain in the neck down the arm, and she was nauseous. She described that she couldn't get out of the bed because of so much body pain. On 21Mar2021, the patient experienced her left side of middle back had some excruciating pain. The clinical course was as follows: I had a major body ache with the second vaccine. I did not have any problem except the headache with the first one but I took second one on this past Friday, I got very nauseous, it started hurting the minute she put it in my arm, which is on the left side. I got a mark on my arm, my arm started swelling. Saturday morning I couldn't get out of the bed because of so much body pain, Sunday my left side my middle back I had some excruciating pain I rushed to the doctor to the ER, my BP went over 269/149 and they had to give me pain medicine and BP medicine to reduce the blood pressure. I made it to the doctor and I'm getting medicine for the pain. I woke up in the morning there's pain in the neck down the arm and it's aching, the side I got the shot, the side is hurting, excruciating pain in my arm. I had to go to the ER straight to my doctor's office, they wouldn't let me drive or anything straight to the ER where they administered 2 doses of pain medicine and 3 doses of blood pressure, the pain was so intensive it made my blood pressure go up, the doctor said all of this was coming from the vaccine." Relevant lab data on an unspecified date in Mar2019 included blood pressure 269/149. The patient received treatment for the events blood pressure high, body pain, neck pain, pain in arm, and back pain. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446955 same reporter/patient/drug, different event in separate dose
60 2021-05-05 lymph node swelling Patient developed bilateral cervical lymphadenopathy on 4/21. She was started on Augmentin 4/23 with... Read more
Patient developed bilateral cervical lymphadenopathy on 4/21. She was started on Augmentin 4/23 without improvement. At time of my exam on 4/27/21 she had a large right fixed submandibular neck mass. CBC 4/27/21 showed mild monocytosis, and US 4/27/21 showed bilateral hypoechoic LNs (R>L with largest node adjacent to R submandibular gland 3.2cm in size) concerning for systemic abnormality such as lymphoma or metastatic disease. Patient was switched to clindamycin on 4/27/21, but developed drug rash, so was ultimately treated with 10-day course of Augmentin and Bactrim with complete resolution of lymphadenopathy when next examined 5/6/21.
60 2021-05-05 swelling Moderna COVID-19 Vaccine EUA: during telehealth encounter nine days after vaccination patient report... Read more
Moderna COVID-19 Vaccine EUA: during telehealth encounter nine days after vaccination patient reports a lump under the collarbone. The provider documented arm redness and a diagnosis of cellulitis and prescribed antibiotics.
60 2021-05-06 peripheral swelling SORE THROAT, COUGH, NASAL CONGESTION, LEG SWELLING, BURNING FEELING TO BOTTOM OF BILATERAL SOLE OF F... Read more
SORE THROAT, COUGH, NASAL CONGESTION, LEG SWELLING, BURNING FEELING TO BOTTOM OF BILATERAL SOLE OF FEET
60 2021-05-06 swelling face, peripheral swelling Extreme fatigue, fever 100.2, hands & face very swollen, no appetite.
60 2021-05-06 swelling face Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eye... Read more
Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eyes it is swollen; She was having severe diarrhea; having severe dry heaves; vomiting bile; It had dehydrated her/lead to dehydration; Her throat closing up and it being sore from vomiting and dry heaving; couldn't swallow to get any fluids in; Her throat closing up and it being sore from vomiting and dry heaving; she was struggling with having a dry mouth; puffiness; Headache; severe muscles aches/Muscles pain; feeling nauseous; Was a little warm on her arms/ it was warm to the touch; it just looked like a bee sting and it wasn't super sore; sensitive to the touch; It had big red spots; had a little tiredness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 16Apr2021 at 10:00 (at age of 60 years old, Lot Number: EW0ISO) as single dose for covid-19 immunization. Medical history included she had lupus, sjogren's syndrome. The patient's concomitant medications not reported. The patient previously took Pneumonia Vaccine on 04Mar2021 (Anatomical Location: Left arm); took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 at 10:00 (at age of 60 years old, Lot Number: the lot number starts with ER something and then it ends with a 3) as single dose for covid-19 immunization; took azathioprine for lupus and had allergic reaction; took belimumab (BENLYSTA), subcutaneous from an unspecified date (Lot Number: PV7G; Expiration Date: Jun2023, NDC: 49401-088-01, Number on the side: 0147098) to an unspecified date, self injection once a week for lupus. She gets it through the VA and it is subcutaneous use and the manufacturer is company. she was immunocompromise, she had lupus, so she was off of her medication (BENLYSTA) for a month per the CDC guidelines. She wanted to let Pfizer know that as well. For her first COVID vaccine she was originally scheduled to go 6 to 7 days after she had her pneumonia shot and they told her that she would have to wait 2 weeks before having her COVID shot and she did. Other than that she had followed the guidelines and she had been able to take her regular medications but she had to stop her Benlysta because of her immune system and everything. She had been following through on what the CDC has said. Patient stated that she just did a follow up with her doctor because of what happened after her second Pfizer COVID vaccine and her doctor recommended her to let Pfizer know about the side effects that she was having. On Friday 16Apr2021 she had her shot at 10 AM and it was no big deal, it was a little warm on her arms. She stated that it just looked like a bee sting and it wasn't super sore, it was warm to the touch and sensitive to the touch. It had big red spots and there has really been no change since it began. It looks about the size of a bee sting and it was still there. She had a little tiredness and she was not hungry but when she woke up at 06:40 the next morning (17Apr2021) on Saturday she was having severe dry heaves and vomiting bile and she could not get it under control. It had dehydrated her and she was having severe muscles aches. She had the severe dry heaves and the vomiting that lead to dehydration and then she went to the emergency room and she got replenished and they had given her something for feeling nauseous and eventually she was released 3 to 4 hours later. They gave her pills as well so she was doing well now and she hasn't done anything since she went to the emergency room with the vomiting and feeling nauseous. She went there about 1030 to 1040. Before she went she couldn't stop and she told herself that if it didn't stop on the 5th time then she was going to go to the emergency room and it got really bad so she had to call 911 to come and get her. Then she was having severe diarrhea on Sunday (18Apr2021) and the only way she could stop that was for her husband to pick up antidiarrheal pills. That only went away because of the medicine from the pharmacy. She had the over the counter medicine and she took Imodium. She hasn't been eating a lot so she hasn't had a bowel movement since she took that medication. When she had diarrhea there was no substance, it was very watery. And now today (unspecified date) she was having another reaction that she was seeing and it was just itching on her hands and her feet. She had been continuing to take the Benadryl and something that they gave her in the emergency room and she had taken Tylenol for the little headache that she has had. She had a slight headache and she was still taking Tylenol like they had recommended. This began the same time as she was vomiting on 17Apr2021 when she was going through all of that she had the slight headache. But her biggest concern was during this time when initially on Saturday (17Apr2021), her throat closing up and it being sore from vomiting and dry heaving, she was having the dry heaves her airway closed shut and she couldn't swallow to get any fluids in. Her concern was that the back of her throat was killing her and it was totally closed up so she had to go to the emergency room. She had recognized this because in the past she has had a medication where she had an allergic reaction (she thinks it is the medication that they gave her for lupus because she has been on several different things. She thinks azathioprine but she can't recall exactly but she thinks that might of been the one that did it to her) and it had closed her esophagus up the same way like this. This time it got worse to where she couldn't even swallow water no less a pill. This was on 17Apr2021. When she went to the emergency room they gave her the hydrocortisone to take it down and she actually had felt better while she was waiting for the saline drop. She was able to swallow when her airway was opened again by the time they treated it with the hydrocortisone. Around 16:00 she was better when she left the emergency room that same day 17Apr2021. She doesn't really have a sore throat, it is pretty fine. It seems to be okay she thinks that once the dry heaves and all that stopped it helped to relax that. She was a little raspy from the whole thing and she was struggling with having a dry mouth but that even had been resolved as far as her throat. She had no other reactions than what she explain but she also had a lot of muscles pain but that was to be excepted because it says that on all that she has read. She had had all of the reactions listed except for fever. She had had chills and then when clammy and then was clammy and had chills. She had all of those side effects listed on the sheet and when she went on Saturday following her vaccine to the emergency room most of the side effects were treated in emergency room. They gave her Pepcid, hydrocortisone through her IV and gave her Zofran for the vomiting and they said to keep taking acetaminophen. They gave her cetirizine for allergy or the itching or whatever and they also gave her famotidine which she thinks is Pepcid. Since being off the lupus drug she was getting her symptoms again such as sensitivity to light, inflammation and the dry heaves didn't help so under her eyes it was swollen and she just takes it as it was because she was not on her medication and she had something else injected inside of her. Also, she had Sjogren's disease too so her eyes were already drier than normal and she had had puffiness since 17Apr2021 when she was vomiting. She just wanted to make sure that Pfizer got that information because she didn t see that listed. The only side effect she was related was the swollen glands and she has glands in her throat but she wanted to be sure that Pfizer had that data just in case if it could help someone else. Again, she wants to reiterate that with her first dosage she had no problems. She couldn t even see the mark and all of this is stemming from the second dose of the COVID vaccine. The outcome of the events "Dry heaves, Bilious vomiting, Dehydration, Her throat closing up and it being sore from vomiting and dry heaving, Unable to swallow, Dry mouth, Nauseous" was recovered on 17Apr2021. The outcome of events "Feeling of warmth, Vaccination site pain, Hyperaesthesia, Vaccination site erythema, Tiredness" not recovered. The outcome of the event "Headache" was recovering. The outcome of other events was unknown. No follow up attempts are needed. No further information is expected.
60 2021-05-07 lymph node swelling, swelling High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; ... Read more
High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; Joint and muscle pain; Blurred vision; Persistent cough; My glands started hurting; My ears hurt specially on the right where the shot was given everything is the worse; Sore throat; Jaw pain; my neck under my chin is swollen and painful; my neck under my chin is swollen and painful; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW016) via an unspecified route of administration in right arm on 19Apr2021 at 17:15 as SINGLE DOSE for covid-19 immunization. Patient was 60 years old at the time of vaccination. Medical history included rheumatoid arthritis, COPD, chronic empyema, asthma, chronic bronchitis, gastritis, irritable bowel syndrome, blood pressure high and digestive disorder, all from an unknown date and unknown if ongoing. Concomitant medications included quetiapine fumarate (SEROQUEL), POTASSIUM CHLORIDE, albuterol sulfate (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), FLUNISOLIDE, FLUOXETINE, HYDROCHLOROTHIAZIDE, IPRATROPIN, METOPROLOL, MONTELUKAST, PANTOPRAZOLE, FAMOTIDINE and LOSARTAN, all taken on unspecified date for unknown indication. In Apr20, the patient had high fever of 107.5 degree fahrenheit, dizziness, nausea, headache, fatigue, joint and muscle pain, blurred vision, persistent cough, my glands started hurting, my ears hurt specially on the right where the shot was given everything was the worse, sore throat, jaw pain and neck pain, my neck under my chin is swollen and painful, abscess in my gum and swelling and blisters in my mouth. On unspecified date, the patient underwent lab tests and procedures which included body temperature 107.5 degree F, blood test which she does every year and she had a follow up every 6 months. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
60 2021-05-07 lymph node swelling body aches; Headache; sleepiness; Fatigue; Chills; body temperature: 97.5-98.7; Ear pain; sense of f... Read more
body aches; Headache; sleepiness; Fatigue; Chills; body temperature: 97.5-98.7; Ear pain; sense of fullness in ears and lymph nodes; sense of fullness in ears and lymph nodes; I feel pretty awful after this first dose.; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 03Feb2021 17:40 (Batch/Lot Number: EL9269) as single dose at the age of 60-year-old for COVID-19 immunisation, offered at the health system she works for and administered at hospital. Medical history included ongoing acoustic neuroma on 8th cranial nerve left side, on the side she felt the intense ear pain, diagnosed 2007-2008, thyroid cancer from 2004 and thyroid removed, her hormone levels are normal, COVID-19 in Dec2020. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). There were no concomitant medications. The patient experienced I feel pretty awful in Feb2021 with outcome of unknown, ear pain on 03Feb2021 with outcome of not recovered, sense of fullness in ears and lymph nodes on 03Feb2021 with outcome of recovered on 05Feb2021, body aches on 04Feb2021 with outcome of not recovered, headache on 04Feb2021 with outcome of recovering, sleepiness on 04Feb2021 with outcome of not recovered, fatigue on 04Feb2021 with outcome of not recovered, chills on 04Feb2021 with outcome of not recovered, body temperature: 97.5-98.7 on 04Feb2021 with outcome of unknown. The events did not require a visit to Emergency Room or Physician Office. The course of events was as follows: Patient expected that since she just had COVID in Dec2020, she thought her response to the vaccine would not be severe because she already had some immunity from the infection. The evening of the vaccine, on 03Feb2021, she experienced ear pain and a sense of fullness in her ears and lymph nodes. The ear pain was almost immediate after vaccination. On 04Feb2021, the next day, she woke up with a headache. It was an unusual headache. It did not go away with Tylenol. Then about halfway through the day, she developed significant body aches like when she had COVID. She also experienced extreme sleepiness like when she had COVID too. She took Motrin and had to lie down during her work day. The Motrin did help. Then mid morning 04Feb2021, she got a chill. She couldn't get warm enough. She had no fever. She checked multiple times. Her temps ranged from 97.5-98.7 on 04Feb2021. She experienced fatigue. She did not know the seriousness for any of the side effects she experienced. As of 05Feb2021, her headache has improved. She was still experiencing sleepiness and fatigue. The chills she developed mid day. She had not them right now. She has better and worse moments just like when she had COVID. She was worried about the second one. The patient underwent lab tests and procedures which included body temperature: 97.5-98.7 on 04Feb2021, COVID-19: positive in Dec2020. No other relevant tests. Therapeutic measures were taken as a result of headache and sleepiness. A Product Complaint was filed.
60 2021-05-09 herpes virus infection, oral herpes Fatigue next day and severe outbreak of herpes simplex on lips inside and out; nares
60 2021-05-12 peripheral swelling Patient reports after first dose on 4/8/21 they had red rash on left arm, itchiness at site of injec... Read more
Patient reports after first dose on 4/8/21 they had red rash on left arm, itchiness at site of injection, then itchiness spread over face and body and lasted for one week. Then on 4/28/21 patient had swelling in their thighs and went to the ER and was diagnosed with Urinary Tract Infection. Patient reports after second dose of pfizer on 5/8/21 getting headache, joint pain, fever, cough, itchiness all over body/face, under right armpit. Symptoms started between 4-7pm on Saturday 5/8/21. Patient reports having fatigue on Sunday 5/9/21 and Monday 5/10/21. Patient self treated at home and took tylenol, ketorolac, and benadryl for symptoms.
60 2021-05-12 swelling Swelling in my arm, collar bone and neck. Difficulty breathing from 1:30 to 5:30 am
60 2021-05-13 peripheral swelling, white blood cell count increased 1st noticed red spots on both arms below the elbows and on my chest on 4/7/21. I had an upcoming app... Read more
1st noticed red spots on both arms below the elbows and on my chest on 4/7/21. I had an upcoming appt. w/ a dermatologist on Friday 4/16, so I waited to see him before doing anything. He wasn't sure what it was, but thought with the location it could be Polymorphic Light Eruption. Was given TRIAMCINOLONE ACETONIDE CREAM 0.1% for the itch. On Monday 4/19 I call the dermatologist to ask if Sunlight Eruption would spread and was told no. It had spread to my thighs, calves, feet, back and the rest of my arms by this time and the itching was uncontrollable. On Monday the 19th I started my version of a dose pack with 30 mg of Prednisone for 6 days.
60 2021-05-16 anaphylactic reaction Anaphylaxis (lip swelling, generalized hives, shortness of breath) within 30-45 minutes of vaccine.... Read more
Anaphylaxis (lip swelling, generalized hives, shortness of breath) within 30-45 minutes of vaccine. Because patient has a history of anaphylaxis, she was able to treat it by giving herself epinephrine, oral antihistamines, and nebulizer treatment with levalbuterol every few hours for the next 3 days. She recovered and did not report this until 5/12/21.
60 2021-05-17 swelling face severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; sever... Read more
severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Mar2021 10:30 (Batch/Lot Number: unknown) as 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 medical history was not reported. Concomitant medications included chlorthalidone; diltiazem; doxepin; famotidine (PEPCID AC); fexofenadine hydrochloride (ALLEGRA). The patient experienced severe systemic itching, facial swelling, hives on back, flushing on chest, face, arms, hands on 18Mar2021 10:45. The 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). Treatment received for the adverse events included diphenhydramine (BENADRYL) and steroids. The outcome of events was recovered in 2021. Information on the batch number has been requested.
60 2021-05-18 swelling, swelling face, peripheral swelling Rash on face; Rash on neck; swollen tongue; swollen lips; swollen face; itchy hands/Itchy; Lip tingl... Read more
Rash on face; Rash on neck; swollen tongue; swollen lips; swollen face; itchy hands/Itchy; Lip tingling; Swelling of the arms; swelling and tingling; swelling and tingling; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer (patient) reported that a 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206, Expiry Date of Covid-19 Vaccine: Unknown), via an unspecified route of administration on 05Mar2021 03:00 PM in the left arm at 1st dose, single for COVID-19 immunisation. The patient age at vaccination was 60 Years. Medical history included vertigo, migraines, Sjogren's syndrome (diagnosed about 10 year ago), thyroid cancer, diabetes and high blood pressure. known allergies included Latex, daptomycin, ceftaroline fosamil, doxcycline, fremanezumab-vfrm. The patient had second shingles shot with Shingrex and she got a few chicken pox rash around the shot itself but that's pretty normal, the onset age was 58 years and at the age of 60 years old at the time of the last flu vaccine, and has received multiple flu shots in the past with unknown brand of flu vaccine. On 05Mar2021 03:15 PM, the patient experienced rash on face, rash on neck, swollen tongue, swollen lips, swollen face, itchy hands/Itchy, lip tingling, swelling of the arms and swelling and tingling. The report received as, on 05Mar2021, received her first Pfizer Covid vaccine dose. 10 minutes later patient had an allergic reaction which included swelling of her lips and tongue, rash on her body, and swollen and itchy hands. The patient reported a second reaction on 07Mar2021, which were the same symptoms as the first and then another (3rd) reaction on 12Mar2021. She has been to the ER 3 times and was prescribed oral steroids and was given a steroid injection each time. She feels that each time the steroid injection wears off, the symptoms return. She wants to know how long this side effect could last. The patient had allergic reactions to it and patient as now had three allergic reactions to it and was wondering have you had other people that have had multiple allergic reactions if the steroid they were given has run out. The patient was given Decadron on day 1 and it ran out in a couple of days because it's a short-acting steroid, then they gave her the longer-acting five-day steroid, betamethasone, patient was taking oral, but it's not as good as the beta methasone shot, patient was asking to have we had other people who have needed more steroids even though the shots have stayed in their system. She wants to know if she is going to have more allergic reactions down the road as the steroids' run out. The patient had three injectable rounds of steroid shots on 05Mar2021, 07Mar2021, and 12Mar2021 and had two courses of oral steroids on 05Mar2021 and 12Mar2021. The patient said 10 to 15 minutes after receiving the shot, had lip swelling and tingling, rash on face, then within a half hour started to swell up. The patient stated that at the center where she got her vaccination, they gave her Benadryl but noticed her symptoms getting worse, packed her up in an ambulance to hospital, and there they gave her Decadron and Pepcid and more Benadryl. The patient states it wasn't anaphylaxis but was an allergic reaction. This was on 05Mar2021, right after getting the shot. It is explained the events improved when given the medications at the ER. She still gets a little itchy once in a while but she is on oral steriods and 50 mg of Benadryl every day. This is her third injectable and second round or oral steriods. Caller has not NDC, Lot, or Expiry for those product as they are from the pharmacy. She also has no NDC, Lot, or Expiry for the Benadryl being used, it is also from the pharmacy. The patient informed as, this was her first Covid vaccination and she was not getting the second one. The patient husband and daughter have had their Covid vaccines and had no reactions at all. The patient was not had covid prior and post vaccination. The patient was not received other vaccine in four weeks. Abd received many daily prescriptions and supplements medications in two weeks. Adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events and treated with Benedryl, Steroids, Pepcid. Outcome of the events itchy hands/Itchy, swelling of the arms, swelling and tingling was unknown, for remaining events outcome was recovering. Follow-up attempts are required. Further information was expected.
60 2021-05-20 swelling face Patient reports 7 weeks prior to her 1st dose of pfizer she received a cosmetic filler in her face. ... Read more
Patient reports 7 weeks prior to her 1st dose of pfizer she received a cosmetic filler in her face. on 5/4 the location where the filler was placed began to swell to the size "of a ping pong ball." As of today (5/21) it has still not resolved. Patient is taking oral prednisone.
60 2021-05-20 swelling face 2.5 days after my second dose, the gum behind my right wisdom tooth & inside cheek became swollen, w... Read more
2.5 days after my second dose, the gum behind my right wisdom tooth & inside cheek became swollen, which I have never experiences. After 2 weeks, my cheek was basically ok & about 2.5-3 weeks the swelling of my gum subsided. I did go to the dentist the weekend after my vaccination & she didn't find any dental issues. I took Tylenol for 6 days, but it was not really helpful, then Advil which reduced the swelling immediately! Also, I used hot/cold compresses outside of my cheek & warm tea bags on my gum.
60 2021-05-21 peripheral swelling left arm swelling and pain
60 2021-05-23 lymph node swelling went in for a CT scan for a fracture and the doctors noticed swollen lymphodes on the left side, wen... Read more
went in for a CT scan for a fracture and the doctors noticed swollen lymphodes on the left side, went in for another scan last Thursday (5/21/2021) and they were still swollen
60 2021-05-25 lymph node swelling tiredness; headache; muscle pain; feeling unwell; swollen lymph nodes; hives with pain in them; pain... Read more
tiredness; headache; muscle pain; feeling unwell; swollen lymph nodes; hives with pain in them; pain; I got Shingles; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 03Mar2021 13:15 (also reported 15Mar2021 13:30) (Batch/Lot Number: ENG198) (at the age of 60 years old) as 1st dose, single for COVID-19 immunisation. Medical history included stage 3 kidney disease and thyroid disorder. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was in doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient had other medications received within 2 weeks of vaccination (unspecified). On 03Mar2021, the patient experienced tiredness, headache, muscle pain, feeling unwell, swollen lymph nodes, hives with pain in them, pain and she got shingles. The events resulted in doctor or other healthcare professional office/clinic visit. The treatment received for the adverse event included Valtrex, anti biotic and creme. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event shingles was unknown; and not recovered outcome for the other events. No follow-up attempts are needed. No further information is expected.
60 2021-05-26 c-reactive protein increased Myopericarditis, chest pain, pericardial effusion, pleural effusion
60 2021-05-26 neck mass Really bad stiff neck; lump in the neck/lymph node that is a lump in her neck above the collar bone ... Read more
Really bad stiff neck; lump in the neck/lymph node that is a lump in her neck above the collar bone on left side; body aches/Bones aching kind of like the beginning of COVID; headache; having a fever of 101F; Sick; This is a spontaneous report from a contactable consumer. This female consumer reported for herself that: Serious: No Patient characteristics: Sex: Female Reaction(s)/Event(s): MedDRA version for reaction/event term LLT: N/A Reaction/event in MedDRA terminology (LLT): Medical Information Potential AE Drug(s) Information: Characterization of drug role: SUSPECT Proprietary medicinal product name: PFIZER-BIONTECH COVID-19 VACCINE Active Substance Information Active Drug substance names: PFIZER-BIONTECH COVID-19 VACCINE Narrative case summary and further information: Case narrative: Originating AE Request: REQ-# Attachments: 1 Reporter Subtype: Patient PQC Present: No AE Present: Yes Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller said she has been transferred from hospital and has reported the AEs (possible duplicate AE); Caller got the first dose of the Pfizer BioNTech COVID-19 vaccine on 25Jan2021 3:22PM in (State name). The next day (26Jan2021), she ended up having a fever of 101F, stiff neck, headache, lump in the neck, and body aches. Her fever broke the next day (27Jan2021) and the other symptoms slowly went away also that day. She mentioned that she had COVID-19 in Jul. She got hospitalized because of pneumonia. She got discharged for that then 14 days later she was hospitalized again because of her high grade fever and collapsed left lung. She also mentioned that she has an autoimmune disease "immunoglobulin anemia" and she has infusions once a week with a medication called "Hiventa". She said that she came from a family of doctors and her uncle who is an immunologist recommended her to call Pfizer to see if we do have recommendations about taking the second dose of the Pfizer vaccine considering her conditions. (This REQ pertains to her AEs after her first dose) Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller mentioned that she had COVID-19 in Jul. She got hospitalized because of pneumonia. She got discharged for that then 14 days later she was hospitalized again because of her high grade fever and collapsed left lung. She also mentioned that she has an autoimmune disease "immunoglobulin anemia" and she has infusions once a week with a medication called "Hiventa". She said that she came from a family of doctors and her uncle who is an immunologist recommended her to call Pfizer to see if we do have recommendations about taking the second dose of the Pfizer vaccine considering her conditions. Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller said her uncle who is an immunologist recommends her to go the Emergency Room if her fever breaks to 103F or higher because her lung might collapse. She wanted to know if Pfizer has any recommendations on that. Follow-up (03Feb2021): This is a follow-up spontaneous report from a contactable consumer. This 60-year-old consumer reported for herself that: Patient characteristics: Age at time of onset of reaction/event: 60 Age at time of onset of reaction/event (Unit): YEAR Weight (kg): 58.97 Height (cm): 164 Sex: Female Relevant medical history and concurrent conditions: Structured information (Patient episode name): COVID-19 Patient Medical start date: Jul2020 Patient Medical comments: Verbatim: COVID-19 Relevant medical history and concurrent conditions: Patient Medical start date: 2013 Patient Medical continuing: Yes Patient Medical comments: Verbatim: Connective tissue disease Relevant medical history and concurrent conditions: Structured information (Patient episode name): Gamma globulinemia Patient Medical start date: 2013 Patient Medical continuing: Yes Patient Medical comments: Verbatim: Gamma globulinemia Relevant medical history and concurrent conditions: Patient Medical start date: 18Nov2020 Patient Medical continuing: No Patient Medical end date: 18Nov2020 Patient Medical comments: Verbatim: Bladder surgery Relevant medical history and concurrent conditions: Structured information (Patient episode name): Pleurisy Patient Medical start date: 2016 Patient Medical continuing: No Patient Medical end date: 2016 Patient Medical comments: Verbatim: Pleurisy Relevant medical history and concurrent conditions: Structured information (Patient episode name): Pneumonia Patient Medical comments: Verbatim: Pneumonia Relevant medical history and concurrent conditions: Patient Medical start date: 2016 Patient Medical continuing: No Patient Medical end date: 2016 Patient Medical comments: Verbatim: West Nile Virus Relevant medical history and concurrent conditions: Patient Medical start date: 2015 Patient Medical comments: Verbatim: Sick with all kinds of weird viruses Reaction(s)/Event(s): Reaction/event as reported by primary source: Sick Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: UNKNOWN Reaction(s)/Event(s): Reaction/event as reported by primary source: Bones aching kind of like the beginning of COVID Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED Reaction(s)/Event(s): Reaction/event as reported by primary source: Really bad headache Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED Reaction(s)/Event(s): Reaction/event as reported by primary source: Fever Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED Reaction(s)/Event(s): Reaction/event as reported by primary source: Really bad stiff neck Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED Reaction(s)/Event(s): Reaction/event as reported by primary source: lymph node that is a lump in her neck above the collar bone on left side Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: UNKNOWN Results of tests and procedures for investigation of the patient: Date: Nov2020 Test: Bloodwork Result: Enlarged red blood cells More information available (Y/N): No Results of tests and procedures for investigation of the patient: Date: Jan2021 Test: Bloodwork Result: Normal More information available (Y/N): No Drug(s) Information: Characterization of drug role: SUSPECT Proprietary medicinal product name: Pfizer COVID-19 vaccine Batch/lot number: EL9263 Dosage text: Unknown strength/volume/dose injection to left arm 15:22 Pharmaceutical form (Dosage form): Injection Indication for use in the case: Vaccination Date of start of drug: 25Jan2021 Action(s) taken with drug: UNKNOWN Drug(s) Information: Characterization of drug role: CONCOMITANT Proprietary medicinal product name: Hizentra Dosage text: 9 grams subcutaneously once weekly Indication for use in the case: Gamma globulinemia Date of start of drug: 2014 Narrative case summary and further information: Case narrative: Submitted by Call Centre 1 Ref: #; ININ: # Selected Report Type: Initial Patient Ethnicity: (Ethnicity withheld) Is the patient also the reporter? Yes Reporter type: Consumer or other non-health professional Reporter telephone: (Phone withheld) Primary / Prescribing Healthcare Professional Info HCP name: Dr. (Name) HCP Occupation/Specialty: Primary Care Physician HCP postal address: (Address withheld) HCP telephone: (Phone withheld) Dates for Sick: (From: Jan2021 To: Unknown) Dates for Bones aching kind of like the beginning of COVID: (From: Jan2021 To: Unknown) Dates for Really bad headache: (From: Jan2021 To: Unknown) Dates for Fever: (From: Jan2021 To: Unknown) Dates for Really bad stiff neck: (From: Jan2021 To: Unknown) Dates for lymph node that is a lump in her neck above the collar bone on left side: (From: Jan2021 To: Ongoing) Is Pfizer COVID-19 Vaccine a Pfizer product? Yes Pfizer COVID-19 Vaccine manufacturer: Unspecified Dates for Pfizer COVID-19 Vaccine: (Start: 25Jan2021 Stop: Unspecified) NDC number of Pfizer COVID-19 Vaccine: Unknown Expiry Date of Pfizer COVID-19 Vaccine: Unknown Other Products: Yes Dates for Concomitant Products Hizentra: (Start: 2014 Stop: Ongoing) Patient History: Yes Patient history: COVID-19 (From: Jul2020 To: Unspecified) Additional Information for Other Conditions: Hospitalized in Jul2020 for this with double pneumonia, left lung collapsed. Because had double pneumonia and collapsed lung she has to see a Pulmonologist for another chest X-ray to see the damage that COVID has done. Patient history: Connective tissue disease (From: 2013 To: Ongoing) Patient history: Gamma globulinemia (From: 2013 To: Ongoing) Additional Information for Other Conditions: 2013 all her cells, everything collapsed: B cells, T cells, C cells were all below average; that's when they realized she had autoimmune disorder Gamma globulinemia and connective tissue disease. Patient history: Bladder surgery (From: 18Nov2020 To: 18Nov2020) Patient history: Pleurisy (From: 2016 To: 2016) Additional Information for Other Conditions: Thinks initially had this in 2016.Hospitalization related to this. Patient history: Pneumonia (From: Unspecified To: Unspecified) Additional Information for Other Conditions: Had pneumonia like 7 times so she is susceptible. Because of this history she has gotten the Pneumonia vaccine and Prevnar 13 vaccine. Prevnar 13 when she was too young, in her 50s like 4-5 years ago because had pneumonia so many times. Prevnar 13:Lot/NDC/Expiry: Unknown, does not have product. She thinks there is a Prevnar 23 now she will have to look into. Patient history: West Nile Virus (From: 2016 To: 2016) Additional Information for Other Conditions: Hospitalized for this. Patient history: Sick with all kinds of weird viruses (From: 2015 To: Unspecified) Additional Information for Other Conditions: Started getting sick a lot with all kinds of weird viruses that she was hospitalized for starting when she moved to (State name) around 2015 Investigation Assessment: Yes Additional Context: This consumer was administered her first dose of Pfizer COVID-19 Vaccine 25Jan2021. She reported before she got Pfizer COVID-19 Vaccine she had history of COVID in Jul2020. After administered Pfizer COVID-19 Vaccine she initially started getting sick unknown date and time, but either around night of 25Jan2021 or 26Jan2021. Sick further described as: started with her bones aching kind of like the beginning of COVID, then really bad headache, then fever. She also had a really bad stiff neck that went away. Fever started at night she thinks 26Jan2021; Temperature reached 101 degrees Fahrenheit; by the next day when she woke up her fever broke. She still had a little bit of a headache. As the day went on all the sick symptoms went away. She still has a lymph node that is a lump in her neck above the collar bone on left side-that is the only thing still ongoing with unknown outcome. The bones aching kind of like the beginning of COVID felt like she did in the beginning when she had COVID in Jul2020. She recovered completely from all the other events on unknown dates. She is not sure if she should call her surgeon about the lymph node that is a lump in her neck. She thought it was kind of unusual to have that kind of a reaction to the first dose of Pfizer COVID-19 Vaccine; she called to ask if these events are normal with the first dose of the Pfizer COVID-19 Vaccine; and if there are recommendations regarding getting the second dose relative to these events. Reporter: Email: Unknown. Primary: Email: Unknown. Pfizer COVID-19 Vaccine: NDC/Expiry: Unknown, this is not on the CDC vaccine record card she was given. Second dose is scheduled 15Feb2021 Unknown if dose will continue unchanged at this point Primary/Prescriber: Email: Unknown. VACCINE SUPPLEMENTAL FORM: Patient Details: Patient Last Name: (Name) Patient First Name: (Name) Address: (withheld) City: (withheld) State: (withheld) Zip Code: (withheld) Phone: (withheld) Patient Age at Time of Vaccination in Years: 60 Pfizer Suspect Vaccine and Vaccination Details: Vaccine Lot Number: EL9263 Vaccine Lot Expire Date: Unknown, not on CDC vaccine record card Time the Vaccination Was Given (24 hour clock): 15:22 Anatomical Location of Administration of Pfizer vaccine considered as suspect: Arm Left For US Only: Vaccination Facility Type: They turned a sports stadium parking lot into a vaccination center For US Only: Vaccine Administered at Military Facility?: No For US Only: Vaccination Facility Address: Facility Name: (withheld) Address: (withheld) City: (withheld) Zip Code: Unknown State: (withheld) Phone: Unknown 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): None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: Vaccines If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: None. Adverse Event (AE) Details: Provide the time of onset of AE(s): Adverse Event: Sick Time of Onset (24-hour clock): Unknown Adverse Event: Bones aching kind of like the beginning of COVID Time of Onset (24-hour clock): Unknown Adverse Event: Really bad headache Time of Onset (24-hour clock): Unknown Adverse Event: Fever Time of Onset (24-hour clock): Unknown Adverse Event: Really bad stiff neck Time of Onset (24-hour clock): Unknown Adverse Event: lymph node that is a lump in her neck above the collar bone on left side Time of Onset (24-hour clock): Unknown Did any AE(s) require a visit to: Emergency Room?: No Physician Office?: No If the patient was hospitalized, how many days was the hospital stay?: Not applicable, not hospitalized. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. AE(s) following prior vaccinations: None. Patient's Medical History (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: All relevant information documented in formal fields of other conditions. Family Medical History Relevant to AE(s): Father has heart disease; has a defibrillator; pacemaker and celiac disease. Cancer runs in her family. All of her sisters have had breast cancer, all of her cousins have had breast cancer, all 3 of her aunts died of breast cancer; and another aunt died of leukemia myeloma acute. Relevant Tests: She takes care of herself and has mammograms. She had some bloodwork done in Nov2020 before bladder surgery, and that bloodwork showed enlarged red blood cells. They did follow up bloodwork in Jan2021 and everything came back normal with that bloodwork. Because cancer runs in her family so strongly she is under the care of a hematologist and cancer specialist. She has bloodwork done every 3 months because when providers looked at her history and hospital history her bloodwork is all over the place, up and down historically. Is there a Product Complaint: Yes Description of Product Complaint: This consumer was administered her first dose of Pfizer COVID-19 Vaccine 25Jan2021. She reported before she got Pfizer COVID-19 Vaccine she had history of COVID in Jul2020. After administered Pfizer COVID-19 Vaccine she initially started getting sick unknown date and time, but either around night of 25Jan2021 or 26Jan2021. Sick further described as: started with her bones aching kind of like the beginning of COVID, then really bad headache, then fever. She also had a really bad stiff neck that went away. Fever started at night she thinks 26Jan2021; Temperature reached 101 degrees Fahrenheit; by the next day when she woke up her fever broke. She still had a little bit of a headache. As the day went on all the sick symptoms went away. She still has a lymph node that is a lump in her neck above the collar bone on left side-that is the only thing still ongoing with unknown outcome. The bones aching kind of like the beginning of COVID felt like she did in the beginning when she had COVID in Jul2020. Pfizer COVID-19 Vaccine: NDC/Expiry: Unknown, this is not on the CDC vaccine record card she was given. Follow-up (13May2021): 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.
60 2021-05-26 peripheral swelling allergic reaction; she couldn't get warm; chills; rash all over; swelling in her arms and legs; diar... Read more
allergic reaction; she couldn't get warm; chills; rash all over; swelling in her arms and legs; diarrhea; Extremely tired; headache; Nausea; her blood pressure was taken and it was 165/40.; her blood pressure was taken and it was 165/40.; throwing up; dizzy; Numb on body on right side; This is a spontaneous report from a contactable consumer (patient). A 60-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 04May2021 08:30 (Lot Number: EW0172) as 1st dose, single for covid-19 immunisation. The patient medical history was reported as none. There were no concomitant medications. Patient had investigation assessment. No additional administered vaccines. No Prior vaccinations within 4 weeks. The patient had an allergic reaction to the first dose of the Pfizer covid 19 vaccine and wanted to know if she should take the other one. The patient had throwing up, numb on body on right side, dizzy, nausea on 04May2021; headache and extremely tired on 05May2021; diarrhea on 06May2021; rash all over, swelling in arms and legs, chills on 08May2021; her blood pressure was taken and it was 165/40 mmHg on 04May2021, she couldn't get warm on an unspecified date. Events did not require a visit to emergency room or physician office. The outcome of events rash all over, swelling in arms and legs, chills was not recovered; event throwing up was recovered on 04May2021; numb on body on right side was recovered on 06May2021; events diarrhea, headache and extremely tired was recovered on 07May2021; events dizzy and nausea was recovered in May2021; of other events was unknown.
60 2021-05-26 peripheral swelling It was swollen up pretty big/My arm swelled up. It almost looked like I had a big muscle; Feeling re... Read more
It was swollen up pretty big/My arm swelled up. It almost looked like I had a big muscle; Feeling really sick; Her arm was hurting/Sore arm; I did have COVID, the virus; Slight headache; Weak; I don't even feel that well right now with the first shot; So I think this was an allergic reaction to the medicine because its not real clear; She was pale and dizzy/kind of dizzy; She was pale and dizzy; Nauseated; She's tired/I just feel tired; I just feel like I am dragging; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0176) dose 1 via an unspecified route of administration in the left arm on 04May2021 (at the age 60 years old), as single dose for COVID-19 immunization. The patient's medical history included patient had a pulled tendon for which she was wearing a boot, hypothyroidism for which the patient was taking Synthyroid since 1991, COVID-19 in Dec2020 and was sick from Dec2020 to Jan2021, it took patient a month to get over it. The patient's concomitant medication included Diclofenac Sodium delayed release tablets 75mg, two times a day for 2 pulled tendons in her foot. On 05May2021, patient's arm was hurting/Sore arm. On 06May2021, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle, feeling really sick. On an unspecified date in May2021, patient did have COVID, the virus, patient was pale and dizzy/kind of dizzy, felt nauseated, tired/ just feel tired like patient was dragging, slight headache, weak, patient didn't even feel that well right now with the first shot and patient thought that this was an allergic reaction to the medicine because it was not real clear. Patient was started on Diclofenac Sodium 75mg two tabs daily- started on Tuesday, the same day she got her Pfizer Vaccine. On an unspecified date, patient had ultrasound of the leg to check for clots, but she did not have any. The patient reported that her arm was still really sore, and she was not as nauseous and pale as she was last night but then was tired and slept all night. She just felt tired. The patient did not receive any treatment for the adverse events. Patient wanted to know if this could be a reaction between the medication (Diclofenac Sodium) and the vaccine and also wanted to know if she was allergic to something in the vaccine and how many days side effects might last, patient did not know anyone who got sick after the first dose. Patient was scheduled for the second dose of the vaccine on 26may2021. Outcome of the pale and nauseated was recovering, patient's arm was hurting/sore arm, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle not recovered was not recovered while for the other events was unknown. Patient reported that her 83-years-old mother got Moderna and her arm was a little sore after the first dose and nothing after the second shot. No follow-up attempts are needed. No further information is expected.
60 2021-05-27 anaphylactic reaction anaphylaxis; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A ... Read more
anaphylaxis; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 60-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 20May2021 11:00 (Batch/Lot Number: EW0165) as single dose for covid-19 immunisation (age at vaccination was of 60 years). Medical history included rheuatoid arthritis, surgical asplenia. Patient also allergic to Pineapple. No other vaccine was recieved by the patient in four weeks. The patient received other concomitant medications in two weeks. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 14:30 (Batch/Lot Number: EW0169) as single dose for covid-19 immunisation (age at vaccination was of 60 years). On 21May2021 12:15, the patient experienced short of breath, increasing difficulty breathing, anaphylaxis, in order hoarseness, voice sounds like laryngitis, in order hoarseness, voice sounds like laryngitis, lips tingling, eyes swelling, wheezing, dizziness. Patient took 50mg Benadryl at 12:30 with no relief and went to ER. The ER (emergency room) diagnosed anaphylaxis and started treatment at 13:37. EpiPen, famotidine (Pepsid), SoluMedrol PF was given as treatment. Patient recovered with lasting effects. No covid prior vaccination was reported. Patient was not tested for covid post vaccination. Outcome of all events was recovered with sequelae. Follow up attempts are needed. Further information has been requested.
60 2021-05-27 lymph node swelling Lymphadenopathy of axilla, neck progressing to painful lymphadenopathy requiring steroid treatment t... Read more
Lymphadenopathy of axilla, neck progressing to painful lymphadenopathy requiring steroid treatment to improve symptoms
60 2021-05-27 swelling Redness, swelling, itchy, heat
60 2021-05-28 lymph node swelling, swelling face headache; severe rashes in my forehead; bumps puffy face; swollen lymphnodes on the right side; sens... Read more
headache; severe rashes in my forehead; bumps puffy face; swollen lymphnodes on the right side; sensitive to touch itching, and burning; sensitive to touch itching, and burning; This is a spontaneous report from a contactable other hcp (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EN6201), dose 1 intramuscular, administered in Arm Right on 11Feb2021 at 10:30 (at the age of 60 years old) as 1st dose, single for COVID-19 immunization. Medical history included hypothyroidism, mild hypertension, acid reflux 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 was allergic to aspirin, NSAID, shellfish and some other fish. Concomitant medications included atorvastatin calcium (ATORVASTATIN CALCIUM); metoprolol tartrate (METOPROLOL TARTRATE); omeprazole (OMEPRAZOLE); levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. On 25Feb2021, 15 days after the first dose she got a headache, severe rashes in my forehead, bumps puffy face, swollen lymph nodes on the right side only sensitive to touch itching, and burning. The symptoms are beginning to subside now but was scheduled to get her 2nd dose on March 4th. She would like some guidance. The patient was treated with antibiotics. The patient visited physician office due to events. The outcome of the events was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
60 2021-06-01 swelling face The first day when I woke up I had really bad back pain and I was really sleepy. towards the afterno... Read more
The first day when I woke up I had really bad back pain and I was really sleepy. towards the afternoon I became very itchy. The itching and hives would become increasingly worse. I didn't take it for anything. On Saturday I went to work still itching I called the nurse at work on the hotline and explained what was happening. I was told to take Benadryl but could not because it would make me drowsy. I finished work and took the Benadryl after. I also started to break out into hives, the itching was turning into hives. On Sunday I got up for work and the hives were large and like welts. This was all over my body. The itching was still present as well. I was advised to go to an urgent care or a doctor. On Monday morning I woke up and everything was swollen: my face, my lips. I went to the Dr's office where they gave me steroids and an epi pen as well as oral steroids. After the steroids, the swelling went down after a few days. The itching had also ceased. The itching lasted from Friday up until Monday when I got the steroid shot on Thursday.
60 2021-06-02 fluid retention First, vaccine caused pain. Second vaccine, caused patient pain and to retain fluid. Patient had an... Read more
First, vaccine caused pain. Second vaccine, caused patient pain and to retain fluid. Patient had an MRI of shoulder and culture of fluid. Fluid tested positive for staph.. Patient was given doxycycline for 10 days. Fluid was drained at hospital. Patient was admitted for overnight stay. Patient has incision in front and back of shoulder. She was diagnosed with tendonitis.
60 2021-06-02 lymph node swelling painful swelling of one or more lymph nodes; tennis ball sized knot in the arm; achy; pain and sligh... Read more
painful swelling of one or more lymph nodes; tennis ball sized knot in the arm; achy; pain and slight swelling at the injection site; pain and slight swelling at the injection site; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Lot Number: EN6203 and Expiry date: Unknown), dose 2 via an unspecified route of administration, on 05Mar2021 at 10:45 as 2ND DOSE, SINGLE for covid-19 administered in Arm Left immunization. Medical history included osteoarthritis, fibromyalgia, asthma and allergy to several foods. The patient did not receive any other vaccine in 4 weeks. Patient was not covid positive prior vaccination. The patient previously took celebrex and experienced Celebrex. Historical vaccination included the patient received dose 1 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiry date: Unknown), on 06Feb2021 at 10:45 am for COVID-19 immunization . On 05Mar2021 at 18:00, the patient experienced pain and slight swelling at the injection site, tennis ball sized knot in the arm and achy on 06Mar2021 and painful swelling of one or more lymph nodes on 07Mar2021. It was reported that on evening of injection (Friday) the patient had pain and slight swelling at the injection site. The next day (Saturday), she had a tennis ball sized knot in the arm which was slightly achy but not really painful. When she woke up on the second after the vaccine (Sunday) she noticed a somewhat painful swelling of one or more lymph nodes under her left arm extending slightly into her left breast. A hot shower has alleviated some of the swelling and pain so far. she expected this would ease up in the next few days. If it does not, she would seek medical advice. No treatment was given for the events. Patient was not tested for covid post vaccination. Outcome of the events were resolving. No follow-up attempts are possible. No further information is expected
60 2021-06-02 peripheral swelling shot entry is the size of an apple; heart palpitations; diarrhea; blisters in her mouth on her cheek... Read more
shot entry is the size of an apple; heart palpitations; diarrhea; blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips; Because of the blisters she had a hard time breathing and couldn't can't eat; had a fever of 102°F; weak; tooth throbbing; body aches; food tasted like crap for anything that she could get into there; Because of the blisters she had a hard time breathing and couldn't can't eat; Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling; injection arm was "swollen so bad" from her neck to her fingertips; vomiting; lightheaded, dizziness; Migraine headache/migraine; her arms swollen down to her fingertips which she could not sleep on her left side; could not get out of bed; 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), via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot Number: EWO182) as single dose for COVID-19 immunisation. Medical history included allergic reaction to back yard tree and had sniffles and watery eyes prior to shot. There were no concomitant medications. The patient received her first Pfizer Covid vaccine dose on 18May2021. That evening she began to experience side effects. Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling. She had Migraine headache and vomiting. At 5 AM the following day 19May2021, she was vomiting, had diarrhea, a migraine, and then developed blisters in her mouth. Because of the blisters she had a hard time breathing and couldn't can't eat, had a fever of 102 degree F, was feeling weak, had to crawl to bathroom. She reported that 24May2021, was the first day that she felt ok. It was reported that her arms swollen down to her fingertips which she could not sleep on her left side, blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips, stated that she could not go to her dentist appointment the following day because of blisters and her tooth was throbbing on 19May2021. Stated that she had migraine headaches with vomiting, diarrhea, heart palpitations, weak, 102 fever, food tasted like crap for anything that she could get into there. The patient is supposed to go on 08Jun2021 for her second shot and was told that the second is worst than the first. Stated that she refused second shot. Stated that she could not get out of bed. Stated that she has a 7 and 8 year old to take care of by herself. Stated that the shot entry is the size of an apple on 24May2021. Clarified that she had the shot in her left arm. Caller stated that she had the Covid shot 18May2021 and she still does feel well today. Clarified that the blisters all started at the same time. Stated that she has had no heart palpitations since 5am this morning (24May2021). Stated that her fever is 99.9 Caller keeps rambling on; unable to clarify details with each event. Stated that the migraine is now a headache. She wants to know what would happen if she doesn't get the second dose of the vaccine. The patient received no treatment. Outcome of the events could not sleep on her left side, could not get out of bed was unknown; peripheral swelling was recovered with sequelae on 23May2021, vomiting was recovered with sequelae on 24May2021; Heart palpitations was recovered on 24May2021; Fever, migraine, couldn't lift up her arm, hard time breathing was recovering; all other events was not recovered. Follow up attempts needed. Further information is expected
60 2021-06-03 swelling face Bright red rash starting to turn purple; raised, angry rash raised, angry rash all overback, chest, ... Read more
Bright red rash starting to turn purple; raised, angry rash raised, angry rash all overback, chest, abdomen, neck and face.; raised, angry rash all over back, chest, abdomen, neck and face; Swollen right side face including cheek, eye and ear; This is a spontaneous report from a contactable consumer, the patient. A 60-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 right arm on 16Mar2021 at 10:45 AM (at the age 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Lyme disease, PCOS, asthma, rosacea, Hashimotos thyroiditis, diverticulosis, celiac and IBS. Multiple food and drug allergies reported. The patient did not receive any other medications 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 was not tested for COVID-19. On 17Mar2021 at 05:00 AM, patient experienced raised, angry rash all over back, chest, abdomen, neck and face. Rash was bilateral and worse on right side. Patient also experienced Swollen right side face including cheek, eye and ear and bright red rash started to turn purple as the day passed. The patient did not receive any treatment for the events. The clinical outcome of rash all over back, chest, abdomen, neck and face, swollen face and red rash was recovering. Information about lot/batch number cannot be obtained. No further information is expected
60 2021-06-06 lymph node swelling 2nd dose: Stinging a few minutes after shot, I felt really woozy, and then started shaking all over... Read more
2nd dose: Stinging a few minutes after shot, I felt really woozy, and then started shaking all over having a hard time processing and talking. Went home the next day (Wed) fever, chills, headache, 24 hours better, returned to work on Thursday, day (2). Day (3), Friday, I noticed a red rash at the site of the injection earlier in the day, but no symptoms, just a little tender. Friday evening I noticed a little SOB, a little burning sensation under my skin on both forearms, and a couple times felt a little dizzy, but I didn't think much about it. Day (4) Saturday morning, I went to spin class, I felt a little off, halfway through spin class I noticed I was struggling with some breathing, thought it was because I was wearing mask, but pushed through. Ran a couple of errands afterwards and then noticed the SOB was continuing, my skin started burning again under forearms and now my legs with tingling into my feet. At this point I decided I probably needed to go home. On my way home my chest started to hurt in the very center of my chest, and slowly felt like some pressure, with squeezing sensation. Then starting at the center of my chest I could almost feel what felt like a numbness creepy from my chest to my throat. I went to the ER. My legs felt really wobbly and had a difficult time walking, and was feeling dizzy. They ran a variety of blood work and tests. They noted my D-dimers were elevated and (4) lymph nodes enlarged. They ran an additional series of test and released me at 10pm with follow-up to cardiologist. I am still experiencing SOB, not as bad, and the burning sensations under my skin.
60 2021-06-07 lymph node swelling a week after the 1st dose, i start having a migraine behind my left ear for a while and then it move... Read more
a week after the 1st dose, i start having a migraine behind my left ear for a while and then it moves at the back of my head and after on the right side. I also have body ache at night and lower back pain. it comes and goes until the time come for the second dose. at first, I simply take tylenol and green tea. After the second dose, the next day, i discover a swollen lymph nod between my neck and my shoulder but closer to my neck area. The following day, I went to my doctor who prescribes a steroid and an antibiotic. However the med is over and i am still having the migraine from time to time and when have it, i also have lower back pain. This week i also feel pain in my ears
60 2021-06-07 peripheral swelling She could not sleep the whole night; Right hand is swollen; She has a sprained wrist; Her hand, that... Read more
She could not sleep the whole night; Right hand is swollen; She has a sprained wrist; Her hand, that is somewhat in pain from the sprain, and is most of the time fine, was in; Her left knee was hurting her a lot worse; Sore arm; First dose: sore arm; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6206) via an unspecified route of administration (age at vaccination 60-year) in Left Arm on 09Mar2021 as single dose for COVID-19 immunization. Medical history included accident (The accident was 25 years ago, and they told her that she had shrunk an inch from the accident. It is hard for her to say) and cardiac disorder (Her dad has heart disease) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 09Mar2021 the patient experienced sore arm after receiving first dose; On 30Mar2021 her hand, that is somewhat in pain from the sprain, and is most of the time fine, was in; her left knee was hurting her a lot worse; sore arm; her right hand is swollen and she has a sprained wrist. On 30Mar2021 09:30 she reported she could not sleep the whole night. The seriousness of all the event was reported as non-serious. Her left knee was hurting her a lot worse was recovering. The clinical outcome for all other events was unknown. No follow-up attempts are needed. No further information is expected.
60 2021-06-07 peripheral swelling Hypersensitivity; I feel like I have a arthritis like rheumatoid arthritis in my hands; little tende... Read more
Hypersensitivity; I feel like I have a arthritis like rheumatoid arthritis in my hands; little tender on the arm; little tender on the arm and it is swollen and little itchy; itchiness on the arm; little tender on the arm and it is swollen and little itchy; itchiness on the arm/ feet are swollen; mild chills; body aches; weird muscle; fatigue; Diarrhea; had marking on my legs actually in elbow area; had like ulcers in my mouth; I lost in the meantime, currently now I am 108 pounds; Bone Ache; blistering in the mouth; blisters; sandpaper like rash on the hands and the feet's; mild rash and itchiness on the arm; This is a spontaneous report from a contactable consumer reported for self. This 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 17Feb2021 Arm Left at the age of 60-year-old as 2nd dose, single (Lot # EN6201) for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Anatomical location: Left Arm for covid-19 immunisation. The patient had it, 2nd one was then on 17Feb2021, 10 days later had a guess what you call hypersensitivity because that is the thing can relate to and the they had at the urgent care (emergency room visit) and then the hospital (further not clarified) because had therapy in multiforme. Symptoms on 27Feb2021 and then had gone through an urgent care that following Tuesday and Thursday went back. So, thought it was from that. She had the initial little tender on the arm and it is swollen and little itchy and then had mild chills and body aches initially and did not take, that is better than other people are having with headaches and everything else but it was 10 days later that had this multiforme beginning of this blisters (27Feb2021), sandpaper like rash on the hands and the feet's (27Feb2021), blistering in the mouth (27Feb2021) and had that everything multiforme all over body it is in neck and head. After the 2nd shot on 17Feb2021. She have been mild rash and itchiness on the arm and then little bit of mild chills and mild body ache, it was nothing serious or anything took a steroid and then 10 days later have little bit of sensitivity on index finger and middle finger and then from the next day had marking on legs actually in elbow area, thought it was mosquito bit because of the experienced of itchiness and then it progressed and migrated upward had sandpaper and blisters on face, hands and feet. The rash was on under, it progressed from the ankle and up through the shoulder and had the blister and sandpaper, rash feeling on hands and on feet and then had like ulcers in her mouth. She also had weird muscle and bone aches, body aches and fatigue and diarrhea and everything but she still had she felt like she had a arthritis like rheumatoid arthritis in hands and feet are swollen. She lost in the meantime, currently now was pounds. Treatments included a corticosteroid shot (Further not clarified) and took steroid for the 5 days at the hospital (further clarification unknown) they give her the shot, corticosteroid shot and then took the pills for the 5 days. Outcome of the events was unknown.
60 2021-06-07 swelling face I had a headache, chills, and a fever. Then I had tingling in my head. I started breaking out in a r... Read more
I had a headache, chills, and a fever. Then I had tingling in my head. I started breaking out in a rash all over my face, especially on the right side and near my eye. My face swelled up completely. I went to the ER. I was diagnosed with Shingles. I was given nerve pain medication. Later I saw another ER doctor and I was given an antiviral & steroid medication, but I was nervous to take it. I then visited my PCP, where they checked my eye.
60 2021-06-10 peripheral swelling Started out as joint pain and heaviness. Progressed to extreme swelling in both hands. Progressed to... Read more
Started out as joint pain and heaviness. Progressed to extreme swelling in both hands. Progressed to upper arm pain. Treating with steroids. Treating with occupational therapy. So far refractory to steroids.
60 2021-06-10 peripheral swelling really bad flare up of rheumatoid arthritis; she had a fever of 101.5 degrees Fahrenheit; she had ch... Read more
really bad flare up of rheumatoid arthritis; she had a fever of 101.5 degrees Fahrenheit; she had chills; After her second COVID-19 Vaccine, she had a headache; After her second COVID-19 Vaccine, she was tired; her hands and feet got real swollen; She said she hadn't felt right; hadn't felt right; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 60-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0162) via an unspecified route of administration in left arm on 23Mar2021 between 17:20-17:30 as 1st dose, single dose for COVID-19 immunization. Medical history included ongoing rheumatoid arthritis (from 2003), she has had rheumatoid arthritis for almost 20 years. Concomitant medication included Xeljanz XR 11mg. On 24Mar2021, patient had fever of 101.5 degrees Fahrenheit, chills, headache, she was tired. On an unspecified date in Mar2021, her hands and feet got real swollen, she had not felt right since she had COVID-19 Vaccine. It was reported that patient received her second shot of Pfizer (COVID-19) Vaccine on 13Apr2021 and experienced really bad flare up of rheumatoid arthritis in Apr2021. The patient stated she got both doses of the Pfizer (COVID-19) Vaccine, and after her second (COVID-19) Vaccine, she had a really bad flare up of rheumatoid arthritis. The patient stated her doctor put her on Prednisone for 2 weeks. Reported she had received her second COVID-19 Vaccine dose right before her 61st birthday. She said she went to her rheumatologist, and her rheumatologist told her she should report her side effects to Pfizer. She said she already reported her COVID-19 Vaccine side effects on V-Safe. Patient took 1 Tylenol (8HR Arthritis Pain Extended Release 650mg, Lot Number: LPA095, Expiration Date: Aug2020) for a fever of 101.5 degrees Fahrenheit. She said the Tylenol helped her fever, providing. Reported the Tylenol 8HR Arthritis Pain Extended Release 650mg was expired, but the product still worked. Patient stated for Rheumatoid Arthritis Flare Up, her rheumatologist prescribed 1 Prednisone 5mg tablet, once a day, for 2 weeks. She said she saw her rheumatologist on 17May2021. She said she completed her Prednisone 5mg prescription, and the Prednisone 5mg tablets were dispensed in a pharmacy bottle, and she didn't have the Prednisone 5mg NDC, Lot, and Expiration Date. Reported she was feeling better now, but wanted to report her Pfizer BioNTech COVID-19 Vaccine side effects to Pfizer, so she could help other people with rheumatoid arthritis. Reported she continued to take her Xeljanz XR 11mg while she took the Prednisone 5mg tablets, providing the Xeljanz XR 11mg (NDC Number: 0069-0501-30, LOT Number: DJ2906, Expiration Date: 31May2022). Reported she was feeling better now, but she was not 100%. She said she could actually walk now. She said she still had swelling in her hands and feet. She said the swelling had improved in her hands, saying she could make a fist now, but she couldn't wear her wedding ring. She her sandals still felt tight on her feet. Reported she was very reluctant to get a COVID-19 Vaccine booster shot in 12 months with her auto immune disease. She said she was not going to get the COVID-19 Vaccine booster, if she was going to have the same reaction she had after her second COVID-19 Vaccine dose. Patient asked if Pfizer had done any studies with people who had rheumatoid arthritis and the COVID-19 Vaccine. The outcome of the event fever, chills, headache was recovered on 25Mar2021 and outcome of the other events was recovering. Follow up attempts are needed. Further information has been requested.
60 2021-06-10 swelling face Erratic blood pressure. Decreased heart rate. Weakness. Fatigue, increase in PVC?s. I am an athlete ... Read more
Erratic blood pressure. Decreased heart rate. Weakness. Fatigue, increase in PVC?s. I am an athlete and was simply unable to workout due to response. I did workout the two days after the vaccine and perhaps I shouldn?t have done that. The following week I was exhausted and ended up I?m emergency room with dropping pulse rate and erratic blood pressure, swelling in my face and ankles.
60 2021-06-12 fluid retention, peripheral swelling, swelling face May 1, 2021 ? Received 1st Covid19 shot around 3:00PM at a Pharmacy. No concerning reaction. May 2,... Read more
May 1, 2021 ? Received 1st Covid19 shot around 3:00PM at a Pharmacy. No concerning reaction. May 2, 2021 ? Arm a little sore at site of shot. Not a problem. Later afternoon some posterior leg muscle pain. Not severe. May 3, 2021 ? Bowels are hardened and a little difficult to push out. In the afternoon definite pain in various places in the large posterior muscles of both legs. In the evening abdominal cramping. A little tired feeling. May 4, 2021 ? Bowels hardened. Abdominal cramping. Deep specific areas of pain in both my posterior leg muscles including: calves, hamstrings, gluteals ? felt like someone sucker punched me up and down the backs of my legs. Right thigh is going numb while I work. Forearms and hands are going much more numb. Extreme fatigue by afternoon, to the point I had to sleep for a while. Diarrhea by early evening. May 5, 2021 ? Hardened bowels. Pain in legs is less severe but still there plus pains in inner thigh. Slight headache (I very rarely get headaches), extreme fatigue by afternoon, Debilitating, I had to take a nap. Thigh continues to go numb off and on while I work. My forearms and hands are tingling and going numb at times. May 6, 2021 ? I am noticing mild headache comes and goes, am experiencing ringing in head like I had with past concussion. Extreme fatigue by afternoon and have to lie down. My bowels are less hardened but still not regular. Still have deep pains in legs muscles but not as severe. Joints are achy: wrists, elbows, hips, knees. May 7, 2021 ? Same as day before. Also realize my blood pressure is running high. May 8, 2021 ? One Week Since Shot. Have noticed I am not able to focus in on specific things as well as normal. The fatigue is debilitating at times. It is affecting my daily chores. I have definitely gained weight, joints continue to be achy and stiff. Less headaches and leg pains are much less. No more abdominal cramping. Bowels are still a little hard. May 8, 9, 10, 11, 12 ? Still more tired than usual but not as debilitating. Bowels are better. My joints and muscles are still sore but not as bad. I am noticing swelling in my arms and legs and face ? feels like I am retaining fluid. I have occasional periods where I am not mentally focused/ forgetting things/ not as observant. Ringing in head happens from time to time. Blood pressure is higher than normal. May 13, 14, 15, 16, 17, 18 ? No more leg muscle pains but continue to have fluid retention. My joints are more sore than normal. Thigh and forearms are no longer going numb. Still more tired than normal but no longer need naps. Mental clarity is better but still feel ?off.? May 19, 20, 21 ? Exhausted. Completely exhausted. Legs and arms and face swollen. Bowels are hardened again. I feel like I have regressed. No deep muscle pain. Joints are stiff again. Mentally out of it. Not able to intently focus. Blood Pressure is up again. May 22, 23, 24 ? Body edema continues. On Sunday the 23rd my face literally swelled up! I took a benedryl and did lymph drainage massage on myself. It eventually went down after several hours. Never experienced difficulty breathing, my parotid glands did not seem to be swollen. May 25 to June 13 - Some days I feel okay, other days I am having swelling in legs, arms / seems like I am still retaining fluid, still more tired than I was before the Covid shot/ still have times a don't focus in as well as normal / joints are stiff at times from swelling and right thigh goes numb off and on when standing.
60 2021-06-13 peripheral swelling Severe headache, vomiting, nauseous, swollen arm
60 2021-06-15 swelling Right arm pain, swelling and redness starting 5/28 lasting 3 days. Chills x2 days starting 5/31/21. ... Read more
Right arm pain, swelling and redness starting 5/28 lasting 3 days. Chills x2 days starting 5/31/21. Constant cough starting 5/31/21 and continues.
60 2021-06-16 lymph node swelling Fever12 hrs Fatigue 12 hrs Swollen Breast Glands left side on going
60 2021-06-16 lymph node swelling Swollen lymph nodes in neck; rash on chin; This is a spontaneous report from a contactable consumer.... Read more
Swollen lymph nodes in neck; rash on chin; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: unknown) via an unspecified route of administration in the Arm Left on 13Mar2021at 12:45 PM (at the age of 60-year-old) for COVID-19 Immunisation. Facility where the COVID-19 vaccine was administered was pharmacy or drug store. Medical history was reported as seasonal allergies, high blood pressure, high cholesterol. Concomitant medications were reported as CLARITAN-D, atorvastatin(MANUFACTURER UNKNOWN), propranolol(MANUFACTURER UNKNOWN), losartan(MANUFACTURER UNKNOWN) for unknown indication from unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not tested for COVID-19. Patient had not symptoms associated with COVID-19. The patient was not enrolled in clinical trial. Information about ethnicity and race is reported. Patient did not have allergies to medications, food, or other product. On 15Mar2021 at 08:00 AM, the patient experienced swollen lymph nodes in neck 2 -5 days after injection rash on chin 2-5 days after injection and the clinical outcome of these events were recovering at the time of this report. The patient did not receive treatment for the events. No follow-up attempts are possible; information about lot number cannot be obtained.
60 2021-06-16 swollen extremities feeling like legs were made of jello.; Very hot; flushed face; weak; Merely nauseated; This is a spo... Read more
feeling like legs were made of jello.; Very hot; flushed face; weak; Merely nauseated; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 05Mar2021 at 12:45 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included hashimoto's thyroiditis. Patient had allergies to penicillin. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN) for an unknown indication. On 05Mar2021 at 13:30, patient experienced very hot, flushed face and weak and feeling like legs were made of jello. This lasted for approximately 3 hours. On 05Mar2021, patient experienced merely nauseated. On 17Mar2021, patient underwent lab tests nasal swab (PCR) and result was negative. No therapeutic measures were taken for the reported events. The clinical outcome of the events very hot, flushed face and weak, feeling like legs were made of jello and merely nauseated was recovered/ resolved on 05Mar2021. No follow-up attempts are needed. No further information is expected.
60 2021-06-17 lymph node swelling When she took her Pfizer vaccine on 5/29/2021, she had a feeling of pressure around her heart that m... Read more
When she took her Pfizer vaccine on 5/29/2021, she had a feeling of pressure around her heart that made her anxious on Day 2 and Day 3, Lymph node under her left arm was swollen the size of a credit card for Days 3 & 4 post vaccine. Had a fever on Day 4 & 5 after the Covid Vaccine. Would wake up in the night with her bed soaked with sweat and she would have to change her clothes. She had a horrible smell in her nostrils. Had diarrhea.
60 2021-06-18 lymph node swelling Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; Within 1 ho... Read more
Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; Pain in the right side of her leg and in her stomach; Caller stated she has been vomiting mainly from the draining that is choking her.; Throat tightened up and glands swell; Barely able to breath, shortness of breath; Pain in right side, below her breast; Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; She was so sick; Caller stated she has been vomiting mainly from the draining that is choking her.; Headaches; Pain in the right side of her leg and in her stomach; Burning in her chest and throat/ pain was in the right side of the chest; Burning in her chest and throat/ throat has been like its on fire; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 02Jun2021 (Batch/Lot Number: EW0177) as 1ST DOSE, SINGLE for covid-19 immunisation. Time the Vaccination Was Given: Between 12:00 and 1:00pm. Medical history included when she was a child, she had bronchial asthma. Has not had any problems in years. Prior Vaccinations (within 4 weeks): No, has been years. Has not even had the flu shot in 3 years. The patient's concomitant medications were not reported. Caller stated she had the first dose of the Pfizer covid 19 vaccine and stated she is having a reaction. Caller stated it feels like she has covid. Caller stated she got the vaccine 3 days ago and within 1 hour had tightness in her chest, wheezing and her throat started to tighten up. All she could do was wheeze. Her throat started tightening up and her glands started swelling. Caller stated she then had draining down the back of her throat. Caller reported burning in her chest and throat. Caller reported pain in the right side of her leg on 02Jun2021 and in her stomach. Caller stated she has been vomiting on 02Jun2021 mainly from the draining that is choking her. Caller stated she is still draining but not vomiting. Caller reported she is having headaches. Caller was concerned about what she should do, go to her doctor or go to the ER. Caller wanted to know how long the symptoms should last. Caller stated she is 52 hours out from the vaccine, Throat tightened up and glands swell, Barely able to breath, shortness of breath, pain on 02Jun2021. She was so sick. She was barely able to breathe within an hour and has been in pain. It is now a struggle, with shortness of breath. Her throat has been like its on fire, and lungs filled with a huge amount of drainage in the back of her throat. Is having right leg pain and pain in her stomach. It is not severe pain, but there is some pain there, is having a lot of burning sensation with the drainage. It now feels like she has Covid now. She read in the paperwork that this could not cause Covid. She was perfectly fine when she had the vaccine. She has no allergies. Does not know what to do. It has been 48 hours. She was perfectly fine until an hour later. She contacted the pharmacy and they didn't do anything. She then contacted this number to report this. Her biggest concern was the severe drainage. There were globs of drainage down the back of her throat. Her chest tightened prior to that and she was wheezing. She has not had bronchial asthma since she was a child. Has had no flus, or nothing. Had the pain after the burning in her chest, the pain was in the right side of the chest. Pain in right side of leg: Hasn't stopped completely. Still has pain in the right leg and in the chest. It is barely any better. It is probably because it is in one spot in the calf on her right leg. The pain in the right side, below her breast. The pain seems to be in the right side. Pain in stomach: Seems to be both sides. Has gotten better some, in the stomach. Vomiting: Was vomiting from all the drainage, it was choking her. It started within 2 hours. She is still experiencing the drainage, but not the vomiting. Has also been experiencing headaches. Shortness of breath: Was the same time as the tightness in the chest. It was within an hour after she left. They kept her there 15 minutes and she was fine when she left. Within the hour, she could barely breathe. She didn't know if she should go to the emergency room or if it would get better in a few days. The shortness of breath and wheezing is not worse, but is constant and really hard. Her breathing is really labored. She is not having pain, other than the tightness and wheezing, which she can hear. It is like she had asthma for years, or pneumonia. Outcome of events Wheezing, Chest burning, Throat burning sensation, headache, and Shortness of breath, pain of was not recovered, of Pain in leg, Stomach pain was recovering, of Vomiting was recovered in Jun2021, of others was unknown.
60 2021-06-18 peripheral swelling Low fever; chills; severe headache; body aches; sore arm; This is a spontaneous report received from... Read more
Low fever; chills; severe headache; body aches; sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6204) via an unspecified route of administration on the left arm on 18Mar2021 at 10:15 as single dose for COVID-19 immunisation. The past drug history included BNT162B2 (BNT162B2); Lot no: EN6202 via unspecified route of administration administered on 25feb2021 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 vaccine. Medical history included High Cholesterol, heart disease on an unknown date. Concomitant therapies were not reported. The patient experienced Low fever, chills, severe headache, body aches, sore arm on 19Mar2021 after vaccination. No therapeutic measures were taken for the events. The clinical outcome of the events Low fever, chills, severe headache, body aches, sore arm were reported as resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
60 2021-06-21 axillary mass I developed a lump between my left breast and armpit (lymph node?)
60 2021-06-21 lymph node pain I had pulsing/fluttering around my heart. Arm pain. Lymph pain. Severe vomiting and diarrhea.
60 2021-06-22 swelling face Patient stated that her face swelled up about 2 hours post vaccine. Client notified me at her appoi... Read more
Patient stated that her face swelled up about 2 hours post vaccine. Client notified me at her appointment of her second dose. Dose was not administered and she was referred to clinic for that dose due to our rural location and lack of emergency services. I called the client to find out how she did with the second dose, she stated they did not administer it. She informed me at that time that she thinks she also had shortness of breath following the first dose while she was driving to work 1 hour away. All symptoms resolved on their own with no treatment.
60 2021-06-24 lymph node swelling, peripheral swelling My hand and fingers were swollen and, unable to stretch fingers; Fingers were very stiff; My hand an... Read more
My hand and fingers were swollen and, unable to stretch fingers; Fingers were very stiff; My hand and fingers were swollen and, unable to stretch fingers; Fingers were very stiff; Mild headache at back of neck; swollen lymph nodes; This is a spontaneous report from a contactable other-health care professional (patient). A 60-year-old non-pregnant female patient (not pregnant at the time of vacciantion) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN5318), via intramuscular route of administration in right arm on 04Feb2021 at 10:00 AM (at the age of 60 year 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: EK4176), via intramuscular route of administration in right arm on 14Jan2021 at 10:00 AM (at the age of 60 year old) for covid-19 immunisation. Medical history included high blood pressure, high cholesterol, seizures from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included vitamin c [ascorbic acid]; colecalciferol (D); zinc; elderberry [sambucus nigra]; paracetamol (TYLENOL), high blood pressure med, seizure meds, high cholesterol med. The patient had no other vaccine in four weeks. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Feb2021 at 02:30 AM, patient experienced hand and fingers were swollen and, unable to stretch fingers; fingers were very stiff; mild headache at back of neck and swollen lymph nodes. The patient did not received treatment due to the events. The outcome of events was recovered on an unspecified date in 2021. Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
60 2021-06-24 lymph node swelling Arm & hand numb during night after injection; lymphadenopathy in left armpit (injection given in lef... Read more
Arm & hand numb during night after injection; lymphadenopathy in left armpit (injection given in left arm); This is a spontaneous report from a Non-contactable Nurse (Patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261), via an unspecified route of administration, administered in left arm on 02Feb2021 (at the age of 60-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included allergic to penicillin and Imipramine, and hypertension. Concomitant medication(s) included Elderberry Syrup, Zicam, HCTZ, lisinopril; all for unknown indications from unknown dates and unknown if ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 12Jan2021 as 1st dose, single 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 03Feb2021, patient experienced arm and hand numb during night after injection, lymphadenopathy in left armpit. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
60 2021-06-27 peripheral swelling Patient reports having a sore arm that is warm to the touch after getting her second Pfizer COVID-19... Read more
Patient reports having a sore arm that is warm to the touch after getting her second Pfizer COVID-19 vaccine. She also reports some continued soreness and itchy feeling in her left arm which is about the size of a hand. She reports that this adverse reaction has improved since it started on 6/23/21 but it is still present ~5 days later. She will continue to monitor, and will report back to us and her primary care physician.
60 2021-06-28 lymph node swelling Day of First shot: headache, sore arm, extreme exhaustion, feeling that some virus or illness was c... Read more
Day of First shot: headache, sore arm, extreme exhaustion, feeling that some virus or illness was coming on, intermittent chills. 36 hours after first shot: sore arm, headache, stomach ache (upper and lower), cramping, swollen gland on front of neck (just one gland). Had all of these symptoms on my second shot too, but not as bad. I did not have a swollen throat/neck gland, BUT had shortness of breath/asthma reaction on my second shot, and chest & sinus congestion. The intermittent asthma/shortness of breath, (haven't had in a long time), was without wheezing. I used my albuterol rescue inhalor and it seems to help me get through these boughts. The asthma came on at about 29-36 hrs and has lasted 6 days so far.
60 2021-06-28 swelling I do not think this is an adverse reaction at all. My lower back started swelling and having pain. ... Read more
I do not think this is an adverse reaction at all. My lower back started swelling and having pain. My chiro is caring for me. I reported this on my form because it asked for new symptoms. The only reaction I have had is my left arm has remained and still is very painful and the pain is deep into my arm at the exam site. I have not told my PCP.
60 2021-06-29 lymph node swelling Loss of smell; Loss of taste; Slightly swollen lymph nodes; This is a spontaneous report from a cont... Read more
Loss of smell; Loss of taste; Slightly swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 60-years old 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 20Mar2021 at 16:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergies to sulfur ingredient. 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 included vyvanse (MANUFACTURER UNKNOWN), dosage 40mg 1xday for unknown indication, omeprazole DR (MANUFACTURER UNKNOWN), dosage 40mg for unknown indication from unknown date. On 21Mar2021 at 08:00 (as reported), patient experienced loss of smell, loss of taste and slightly swollen lymph nodes. The clinical outcome of the events of loss of smell, loss of taste, slightly swollen lymph nodes were unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
60 2021-06-29 peripheral swelling Reaction on arm; Itchy; Red; swollen arm; This is a spontaneous report from a contactable consumer, ... Read more
Reaction on arm; Itchy; Red; swollen arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-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 left arm on 11Mar2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to Sulfa, eggs and shellfish. 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 VIIBRYD, quetiapine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and spironolactone (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 20Mar2021 at 10:00, the patient had reaction on arm on the ninth day following the vaccine. The patient reported that it was itchy, red and swollen. 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 reaction on arm, itchy, red and swollen was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
60 2021-06-29 peripheral swelling Swelling and pain under the arms; Swelling and pain under the arms; This is a spontaneous report fro... Read more
Swelling and pain under the arms; Swelling and pain under the arms; This is a spontaneous report from a contactable consumer, the patient. A 60-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 02Mar2021 at 8:45 as a single dose for COVID-19 immunisation. Medical history included thyroid. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), metoprolol ER succinate (MANUFACTURER UNKNOWN). The patient had a history of drug allergy to hydrocodeine. 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 24Feb2021, the patient underwent lab test included a nasal swab and the result was negative. On 02Mar2021, the patient developed swelling and pain under the arms. No treatment was received for the events. The clinical outcome of the events swelling and pain under the arms was resolved on an unknown date. Information about lot number cannot be obtained. No further information is expected.
60 2021-06-29 swelling, swelling face Patient complained of swollen neck, ear, and jaw tendon. Wanted it to be reported. It happened abou... Read more
Patient complained of swollen neck, ear, and jaw tendon. Wanted it to be reported. It happened about 5 days after she received the vaccine.
60 2021-06-30 lymph node swelling, lymph node pain Swollen lymph nodes : left armpit, breast; right neck above an below collar bone and into armpit. Ab... Read more
Swollen lymph nodes : left armpit, breast; right neck above an below collar bone and into armpit. Above collarbone is a hard nodule with swollen line over collarbone that radiates toward armpit; Swollen lymph nodes: Very painful.; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route on the right arm on 12Mar2021 16:30 (at the age of 60-year-old) as a single dose, for COVID-19 immunisation. Medical history included mitral valve prolapse, Penicillin allergy, Sulfa allergy, contrast agents allergy and shellfish allergy. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN), cranberry pills (MANUFACTURER UNKNOWN) and b complex (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient previously took cefaclor monohydrate (CECLOR)and cefalexin monohydrate (KEFLEX) for unspecified indication from unknown dates and experienced drug allergy. 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 positive for COVID-19. On 15Mar2021, the patient experienced swollen lymph nodes from left armpit, breast, right neck above and below collar bone into armpit (lymph nodes cervical swollen). There was a hard nodule with swollen line over collarbone which radiated toward armpit and was very painful (lymph node pain). The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of event and included the treatment with X-ray with CT scan to follow (No details to confirm if patient underwent these investigations). The clinical outcome of events lymph nodes cervical swollen and lymph node pain was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
60 2021-06-30 lymph node swelling Headache; Dizziness; Fatigue; Nausea; Swollen lymph node; Sore arm; This is a spontaneous report fro... Read more
Headache; Dizziness; Fatigue; Nausea; Swollen lymph node; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old 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 20Mar2021 at 10:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included losartan (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and labetalol (MANUFACTURER UNKNOWN), all for unknown indication within two weeks of vaccination. The patient did not receive any other vaccines within 4 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 been tested positive for COVID-19. On 20Mar2021, at 19:00, the patient experienced headache, dizziness, fatigue, nausea, swollen lymph nodes, sore arm. 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 treatment for the reported events. The clinical outcome of the events headache, dizziness, fatigue, nausea, swollen lymph nodes and sore arm was resolved on an unknown date in Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.
60 2021-06-30 peripheral swelling In the week after receiving the second vaccine, I developed various joint pains and muscle pains, at... Read more
In the week after receiving the second vaccine, I developed various joint pains and muscle pains, at times severe. The first event was both knees becoming very stiff and sore. It lasted about 24 hours. A day later, both my hands became swollen and stiff. Ibuprofen seemed to alleviate the problem. Since that time, at approximately 3-4 day intervals I developed pains in hands and knees again as well as ankles, bicep muscles, wrists, and jaw. This has continued for the last 3 months, and is now only in one of the pair of joints at a time, as in just one knee, not both at the same time. My right wrist is most commonly affected.
60 2021-07-08 lymph node pain, lymph node swelling Patient reported several itchy wheals/hives that started on the writs of the arm the vaccination was... Read more
Patient reported several itchy wheals/hives that started on the writs of the arm the vaccination was given in, and some on the opposite arm. They were limited, not widespread. These began the day following vaccination. Roughly 12 hours post-vaccination she stated she had a severe headache that woke her up. This headache continued 7 days, peaking on day 3. She almost went in for treatment, but did not end up doing so. She also reported swollen, tender lymph nodes in axilla on side of vaccination, as well as a blood nose.
60 2021-07-08 lymph node swelling Swelling in glands/lymph nodes; earache (right ear); burning and tightness in chest; burning and tig... Read more
Swelling in glands/lymph nodes; earache (right ear); burning and tightness in chest; burning and tightness in chest; Aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 60- 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 15Mar2021 at 15:15 (at the age of 60-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 been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling in n glands/lymph nodes, earache (right ear), burning and tightness in chest, aches and fatigue on 19Mar2021. The patient underwent lab tests and procedure which included COVID test (Nasal swab) on an unknown date and tested negative. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The clinical outcome of events swelling in n glands/lymph nodes, earache (right ear), burning and tightness in chest, aches and fatigue was not resolved. No follow-up attempts are needed. No further information expected.
60 2021-07-08 peripheral swelling Headache; Fever; chills; Body ache; Nausea; Swollen armpit; This is a spontaneous report from a con... Read more
Headache; Fever; chills; Body ache; Nausea; Swollen armpit; This is a spontaneous report from a contactable consumer, the patient. A 60-years-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 23Mar2021 at 09:30, (At the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, atrial tachycardia, thyroid disease and Hashimotos disease. Concomitant medications taken within 2 weeks prior to vaccination include Levothyroxine (MANUFRATURER UNKNOWN) and Diltiazem hydrochloride (CARTIA) both for unspecified indications. 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 left arm on 02Mar2021 at 10:00 as a single dose for COVID-19 immunisation. The patient was allergic to codeine and demerol. Prior to 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 any other vaccines within four weeks prior to the COVID-19 vaccine. On 23Mar2021, the patient experienced headache, fever, chills, body aches, nausea and swollen left armpit. The adverse event had not resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care. The patient did not take any medication for headache, nausea, chills, fever, swollen arm, general body pain. The clinical outcome of the events headache, nausea, chills, fever, swollen arm, general body pain was recovering at the time of this report. No follow-up attempts possible. No further information expected.
60 2021-07-10 swelling Rash; Swelling on my collar bone; High Fever; Dizziness; Headache; This is a spontaneous report from... Read more
Rash; Swelling on my collar bone; High Fever; Dizziness; Headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0177, Expiration Date was not reported), via an unspecified route of administration, administered in Deltoid Left on 16May2021 (at the age of 60-year-old) as single dose for COVID-19 immunisation. Anatomical site of vaccination was left shoulder. The patient medical history included thyroid. Concomitant medications included levothyroxine (LEVOTHYROXINE); acetylsalicylic acid (ASPIRIN (E.C.), 81mg); metoprolol (METOPROLOL). The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. It was reported that, patient stated that she was calling because she had her second shot on Sunday, she had a reaction to the shot which was normal, which was the high fever and dizziness and a headache but today she had rash and it was swelling on her collar bone. She did not know if that was another reaction to that, she knew the rash was normal, but she did not know about the swelling on her collarbone. Patient was asking was that okay or there was something she should do. Consumer stated, she just was wondering about the swelling on the collarbone was that something she need to worry about, or should she just take some like Benadryl or something for allergic reactions to it or what she should do. Events still experiencing includes the rashes and swelling on the collar bone. Consumer stated, just today, she got her blood work done. She did not know it was just her thyroid check and her cholesterol check. The patient underwent lab tests and procedures which included blood test: unknown on 18May2021. Consumer stated, "Rosuvastatin" (Not appropriately clarified hence, not captured in tab). No treatment received. The outcome of the event swelling on her collar bone was not resolved and unknown for other events. Information on lot/batch number was available. Additional information has been requested.
60 2021-07-11 swollen extremities Hi I got my second Covid shot on Saturday July 10. Shot was in the left arm. Severe headache withi... Read more
Hi I got my second Covid shot on Saturday July 10. Shot was in the left arm. Severe headache within five minutes like last time. Felt like a migraine. After an hour the worse pain was in my left breast & armpit. My left armpit was swollen significantly & my breast felt like I was punched or stabbed. I couldn?t lift my left arm. I applied heat & ice alternately & took Tylenol. Then whole body ached like the flu. No worries there, it?s the swollen left armpit & pain in breast that is bad. Yesterday it got worse. I continued with heat, ice & Tylenol. I took today off because the pain is severe & I can only lift my arm half way up. The severe pain feels like how you feel after a surgery when pain meds start to wear off. Do you know how long this will last?? Thanks & have a great day.
60 2021-07-11 peripheral swelling LA- 1st Covid Vaccine. IMMEDIATELY after Vaccine: Tingling & NUMBNESS to my fingertips. By Nine PM... Read more
LA- 1st Covid Vaccine. IMMEDIATELY after Vaccine: Tingling & NUMBNESS to my fingertips. By Nine PM the night of vaccination, arm pain 10/10 with severe swelling, no mobility and feeling of a dislocated shoulder and elbow. Severe pain the next day accompanied by loud "Cracking" of my L Shoulder and L Elbow. Ongoing Shoulder/Arm pain with decreased mobility and numbness to the fingertips along the ulnar nerve & "cracking". Taking Motrin. Rotational shoulder pain. Consult Dr. 4/22/21. Consult Dr. (orthopedics)-- Prednisone prescribed. Pain improved a bit for 4 days- then pain and rotational problems continued. On 07/12: Visit to Dr., Orthopedics at hospital-- 2nd Prednisone dose pack. Continued from 1st page: 2nd Prednisone dosepak prescription. Was told my Dr. that I had probable improper administration (wrong location- too high) of Covid vaccine and severe, prolonged inflammatory response. I have been referred to physical therapy to improve mobility. Physical Therapy will call me for consult. Problem ongoing... I am tired of filling out this form and keeping it on my desktop.
60 2021-07-11 swelling face Face bright red & swollen, red rash all over my body, headache, dizziness within the first few hours... Read more
Face bright red & swollen, red rash all over my body, headache, dizziness within the first few hours of vaccination. The first evening my headache got significantly worse. I was extremely thirsty, very tired, nauseous, vomiting, diarrhea, muscle pain, chills, fever, my left arm was very sore & swollen @ the injection site. I slept for longer periods of time than normal, very disoriented & not clear on my thoughts & memory for days after.
60 2021-07-12 swelling face hives on my knees; light sensitivity; concentration difficult throughout experience; felt very dizzy... Read more
hives on my knees; light sensitivity; concentration difficult throughout experience; felt very dizzy; Knees swollen; neck discomfort; headache; area swollen from nose to chin; sore injection site,; fatigue; foggy during day; felt my heart beating hard within 5 minutes of vaccine; my lips were numb; I felt a little trouble swallowing.; Had chills; had swelling around lips/mouth; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no : ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 11:300 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. The patient had no Medical history. Concomitant medications included with supplements. The patient previously received Sulpha Drugs 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 24Mar2021 at 11:00, the experienced heart beating hard within 5 minutes of vaccine and her lips were numb and she felt a little trouble swallowing, and had chills, and had swelling around lips/mouth. On 25Mar2021, the Patient experienced area swollen from nose to chin and Had headache, sore injection site, fatigue, foggy during day. On 26Mar2021, the patient experienced Fatigue and neck discomfort. On 27Mar2021, the patient experienced very dizzy, Knees swollen and Could not sleep on injection site. On 28Mar2021, the experienced hives on her knees, Light sensitivity and concentration difficult throughout experience. The patient underwent lab tests and procedures, which included Blood pressure on unknown date and resulted normal. The patient called clinic for instructions and receive Benadryl for lips numbness, heart beating hard, trouble swallowing and chills. Patient had called doctor and awaited to call back. The clinical outcome of felt heart beating hard, numb lips, trouble swallowing, chills, area swollen from nose to chin, headache, fatigue, foggy during day, neck discomfort, dizzy, swollen knees, hives on knees, light sensitivity and concentration difficult was not recovered and of the vaccination site pain was recovered on 26mar2021. No follow-up attempts are possible. No further information is expected.
60 2021-07-17 peripheral swelling, swelling feels hot to touch; Swollen; Having the redness on the arm/tiny redness; Arm feels hard inside like ... Read more
feels hot to touch; Swollen; Having the redness on the arm/tiny redness; Arm feels hard inside like its inside the muscle; Redness on her arm (where the injection was given)/bit of redness, tiny redness, the size of a penny; This is a spontaneous report from a contactable consumer or other non-HCP. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180), via an unspecified route of administration, administered in Left Arm on 27Jun2021 10:00 as DOSE 2, SINGLE (at the age of 60-year-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180) administered in Left Arm on 06Jun2021 at 12:00 for covid-19 immunization and had a little bit of tiredness and sleepiness. On 27Jun2021 the patient experienced redness on her arm (where the injection was given) and bit of redness, tiny redness, the size of a penny. On 28Jun2021 the patient experienced feels hot to touch, swollen, having the redness on the arm/tiny redness, arm feels hard inside like its inside the muscle. The patient's arm feels hot to the touch and swollen: The next morning, 28Jun2021, in the morning, the caller finds out that her arm is swollen, not the whole arm, but the area where the caller received the second dose Pfizer Covid Vaccine, it was maybe 5 to 6 centimeters that it was swollen. The patient arm feels hard inside like its inside the muscle. Her arm was hard when touching the muscle, will feel hardness inside when touching arm. Her arm feels hot to the touch and swollen: The arm felt hot, warm, and swollen. Her arm feels hot to the touch and swollen: In the night hours, maybe about 2000, the callers arm swelling was already 9.5 centimeters, the swelling grew. All day on 28Jun2021, the caller was putting a little ice pack and wet and cold things onto the arm. Today, 29Jun2021, in the morning the caller finds out the size is the same. Her arm feels hard inside like its inside the muscle: The hardness in the caller's arm muscle is a little less. The caller doesn't feel the big chunk inside of the arm. There is a little less hardness. Her arm feels hot to the touch and swollen: The swelling is the same. The size is the same on the arm. Her Has redness on arm where the second dose Pfizer Covid Vaccine was given: The color is the same on the arm. Therapeutic measures were taken as a result of swollen. The outcome of event arm feels hard inside like its inside the muscle was recovering. The outcome of rest all events was not recovered.
60 2021-07-19 axillary mass Pain right underarm area; Severe headache; swelling in right underarm area; This is a spontaneous re... Read more
Pain right underarm area; Severe headache; swelling in right underarm area; This is a spontaneous report from a contactable consumer, the patient. A 60-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 25Mar2021 at 15:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and did not receive any concomitant medications. 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 04Mar2021 at 15:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to 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 17Mar2021, the patient had undergone nasal swab test for COVID-19 and the result was negative. On 26Mar2021 at 17:30, the patient experienced pain and swelling in right underarm area and severe headache. The adverse 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 events pain and swelling in right underarm area and severe headache. The clinical outcomes of the events pain and swelling in right underarm area and severe headache were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
60 2021-07-19 lymph node swelling Found a lump on left side of my breast. Diagnostic mammo/ultrasound found a second, more questionab... Read more
Found a lump on left side of my breast. Diagnostic mammo/ultrasound found a second, more questionable lump in deep left axilla.
60 2021-07-21 anaphylactic reaction New onset eczema- Filed earlier report about being bitten by fire ants two weeks after second covid ... Read more
New onset eczema- Filed earlier report about being bitten by fire ants two weeks after second covid shot and having anaphylactic reaction with no prior history of insect bite allergies and have been bitten alot including the harvester ant. Now have epipen. Then started fire ant shots in June and developed butt tingling/numbness and muscle and body aches after 2nd fire ant shot. By third shot on on July 1st, I had fatigue, extreme musculoskeletal pain and developed a rash. It was really scary so went to the allergist who referred me to my GP. She thinks it is serum sickness. Saw the dermatologist today about the rash and it started about 3 to 4 days after the third fire ant shot. I have never had eczema in my life either. After three weeks from July 1st, am starting to feel better. Not sure if serum sickness caused by molecular mimicry hypersensitive immune syndrome caused by Covid vaccine or not, but there are a lot of immune mediated things happening to me in less than 3 months. My brother developed pericarditis after the second Pfizer shot and I told him to file a VAERS as well.
60 2021-07-21 lymph node swelling, lymph node pain swollen lymph node in left shoulder; swollen lymph node in left shoulder that moves and was painful ... Read more
swollen lymph node in left shoulder; swollen lymph node in left shoulder that moves and was painful first couple days; This is a spontaneous report from a contactable consumer, the patient. A 60-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 26Mar2021 at 14:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient medical history included GERD, blood pressure high, clot blood and the patient was allergic to albuterol. Concomitant medications included xerolto (MANUFACTURER UNKNOWN), bystolic (MANUFACTURER UNKNOWN) and pantoprazole (MANUFACTURER UNKNOWN) taken with in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 05Mar2021 at 14:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. 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. On 27Mar2021, the patient experienced lymphadenopathy and lymph node pain. The patient reported that she had swollen lymph node in left shoulder that move and was painful first couple days but subsided, still swollen but less so one week later. 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 lymphadenopathy and lymph node pain were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
60 2021-07-22 peripheral swelling Swelling in breaststroke and under left arm; Swelling in breaststroke and under left arm; This is a ... Read more
Swelling in breaststroke and under left arm; Swelling in breaststroke and under left arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN8727) via an unspecified route of administration in the left arm on 27Mar2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was receiving unspecified concomitant medications. The patient previously received penicillin (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN) on unknown dates 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 COVID-19 vaccine. On 31Mar2021, the patient experienced swelling in breaststroke and 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 event swelling in breaststroke and under left arm. The clinical outcome of the event swelling in breaststroke and under left arm was resolving at the time of the report. No follow-up attempts are needed. No further information is expected.
60 2021-07-22 swelling Fever; body aches; rash on chest and stomach; rash on chest and stomach and swollen where rash is; T... Read more
Fever; body aches; rash on chest and stomach; rash on chest and stomach and swollen where rash is; This is a spontaneous report from a contactable consumer, the patient. A 60-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 the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure. 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 concomitant medications. Allergies to medications, food, or other products was reported as Bo. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. On 01Apr2021 at 00:00, the patient experienced fever, body aches, rash on chest and stomach and swollen where rash was. The events resulted 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, body aches, rash on chest and stomach and swollen where rash was were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
60 2021-07-27 axillary mass In my arm pit of my left arm it swelled up; In my arm pit of my left arm it swelled up and was very ... Read more
In my arm pit of my left arm it swelled up; In my arm pit of my left arm it swelled up and was very painful; Dose 1 Start date: 20210203/ Dose 2 Start date: 20210218; This is a spontaneous report from a contactable other healthcare professional, the patient. A 60-year-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 in the left arm on 18Feb2021 at 13:00 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included low thyroid. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) on an unknown date for unknown indication. 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 03Feb2021 at 10:45 (at the age of 60-years-old), as a single dose for COVID-19 immunisation (The vaccine was administered outside the range of 19-42 days (15 days) resulting in Inappropriate schedule of vaccine administered and medication error). The patient past drug therapy included lisinopril (MANUFACTURER UNKNOWN) on an unknown date for unknown indication. 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. On 21Feb2021 at 03:00, the patient's arm pit of the left arm swelled up and was very painful. Her doctor put her on steroids and the pain went away but the swelling has not totally gone away and is sometimes painful. The patient went back to her doctor 6 weeks later with the complaint that it was still swollen and sometime painful. The doctor ordered an ultrasound and blood test but all was negative. It was still swollen and sometimes painful that has not gone away yet. On an unknown date, patient underwent lab tests and procedures which included ultrasound and blood test and the results were negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included treatment with steroids. The clinical outcome of the events arm pit of the left arm swelled up and was very painful was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
60 2021-07-27 peripheral swelling excruciating pain in the bones; sharp neck pain; Headache; sore throat; Difficulty swallowing and br... Read more
excruciating pain in the bones; sharp neck pain; Headache; sore throat; Difficulty swallowing and breathing; Difficulty swallowing and breathing; Swollen and blistered on the right leg; Swollen and blistered on the right leg; itch and hurt; itch and hurt; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration in Arm Right on 04May2021 10:00 (at the age of 60 years old) as single for COVID-19 immunisation at Hospital. Medical history included lupus erythematosus, rheumatoid arthritis, fibromyalgia. Concomitant medication received within two weeks included baclofen (SOLOFEN), clonazepam (KLONOPIN), trazodone hydrochloride (TRAZODON) all taken for an unspecified indication, start and stop date were not reported and Plasma Capilar. The patient previously took tramadol and experienced allergies, ultacit and experienced allergies, ultram and experienced allergies. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Arm Right on 13Apr2021 08:00 (at the age of 60 years old) as single for COVID-19 immunisation. Patient did not have COVID prior to vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced excruciating pain in the bones, sharp neck pain, headache, sore throat, difficulty swallowing and breathing, swollen and blistered on the right leg, itch and hurt on 06May2021 16:00. Event reported as, After three days excruciating pain in the bones. Still sharp neck pain. Headache and sore throat. Difficulty swallowing and breathing. Swollen and blistered on the right leg. They itch and hurt. The pain in the neck is excruciating. Adverse events resulted in emergency room/department or urgent care. Treatment given for adverse events included toradol, sodomedrol, ataraxia, norflex. Patient did not tested for COVID post vaccination. Outcome of all the events were not recovered. Information about/lot batch number is requested.
60 2021-07-27 swelling the aches and pains were severe and affected all of her joints; cramping up in her calves and it hur... Read more
the aches and pains were severe and affected all of her joints; cramping up in her calves and it hurts; sight issues; She could barely move; arthritis; she has real sensitivity to light; She still has pain in her knees when she walks, it's almost like her knees want to give out. Severe pain in hips; severe pain was also in her back, hips and neck; severe pain was also in her back, hips and neck; aches and pains; Diarrhea; Severe fatigue; a little bit of swelling; pain at the site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0169; Expiration Date: Aug2021, at the age 60-year-old), dose 1 via an unspecified route of administration, administered in arm left on 27Apr2021 13:00 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Prior vaccinations (within 4 weeks), adverse events following prior vaccinations, patient's medical history (including any illness at time of vaccination), family medical history relevant to adverse events and relevant tests: none. Caller stated she had the shot and a reaction with the first shot and haven't had the second. She clarified she was referring to the covid 19 shot. On 27Apr2021, she had the first vaccine. The day of the vaccine, she experienced normal swelling, a little bit of swelling (not much), and pain at the site, which was normal. The pain went away but she doesn't know it went away. No treatment received. Then, after a few days, she started out with aches and pains but then it got to the point, the aches and pains were severe and affected all of her joints. She could barely move. Her husband had to help her on and off the toilet and that lasted a good week. She also mentions she had diarrhea. She doesn't know. It was probably a couple days later after receiving the vaccine. She was still having diarrhea, but it had improved. She has been taking Imodium. Patient reported that 2 days after she got the shot, she was severely fatigued and that's when the aches and pains started. Caller doesn't know the exact date. If she stands for more than 5 minutes, she has cramping up in her calves and it hurts. She confirms she has recovered with lasting affects. She adds she also has arthritis which might be a factor. She clarifies the aches and pains started on third day. She believes the third day, she is not exactly sure. The aches and pains got worse. When she says severe fatigue, she means she was in bed all day. Time of onset: She would say the fatigue started the 2nd or 3rd day. She provides the start date as: 29Apr2021. The severe fatigue is better than it was but hasn't gone away. She makes the comment she doesn't know why she reacted so bad to the first vaccine. She mentioned she was supposed to go on 18May2021 and get second shot, but she cancelled it. She explains this is one of the reasons she is calling. She needs to know should she get the second shot. Patient wanted to be protected against covid the best she could, her husband has major heart issues and she can't have him being exposed to the virus and she needs to get a shot. She's scared. DSU agent stated we suggest caller reach out to her primary care provider if she has questions on whether or not to get the second vaccine we wouldn't be able to provide her with any medical advice over the phone. Caller stated her doctor said not to take the second shot because she had such a severe reaction to the first one. Her main problem is that she is having sight issues. She has her husband read off the product information from her vaccine record card because she can't really see it. She has always been near sighted but this is to the point, she has real sensitivity to light, that's her main concern right now. First, she had severe pain and then had sight issues. She explained the sight issues started about two weeks in after receiving the first dose, it was right after the severe pain. It has persisted. She has an appointment on Thursday to see her ophthalmologist. She mentions its hard to get into her ophthalmologist. The severe pain started on the 4th day after receiving the first dose, around 30Apr2021. The severe pain lasted a good week, week and a half. She still has pain in her knees when she walks, it's almost like her knees want to give out. Other than that, it's better. She mentions the severe pain was also in her back, hips and neck. Her doctor prescribed diclofenac, 50 mg. She mentions she can see this dose because its bolded and its bigger. No emergency visit. The doctor said to call and see what Pfizer had to say about the second shot because she is really nervous. The outcome of event a little bit of swelling was resolved, diarrhea, fatigue was was not recovered and outcome of all other events was unknown. No follow-up attempts are needed. No further information is expected.
60 2021-07-28 lymph node inflammation, lymph node swelling lymphadenitis; gland swelling; periorbital edema; severe muscle cramping; This is a spontaneous repo... Read more
lymphadenitis; gland swelling; periorbital edema; severe muscle cramping; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 21May2021 08:00 am (batch/lot number EW0161 and expiry date unknown) at 60 years of age as dose 1, single for covid-19 immunization. The patient informed that the facility where the most recent COVID-19 vaccine was administered was in the hospital. Medical history included graves disease. The patient had no covid prior vaccination/was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included levothyroxine for unspecified indication from unspecified. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In May2021, the patient experienced lymphadenitis, gland swelling, periorbital edema, severe muscle cramping. The events resulted to emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. The patient was hospitalized for 1 day due to the events. The patient underwent lab tests and procedures which included COVID-19 (BP) (nasal swab) on 24May2021, 01Jun2021, 10Jun2021, 15Jun2021, 21Jun2021, 29Jun2021, and COVID-19 (RAPID) (nasal swab) on 24Jun2021; all negative. The patient received treatment of prednisone w/taper, magnesium. The outcome of the events was not recovered.; Sender's Comments: The contributory role of the suspect product bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), (batch/lot number EW0161 and expiry date unknown) to reported events is possible based on temporal association and known profile of the product.
60 2021-07-28 sepsis Patient hospitalized for bacteremia, severe sepsis with acute organ dysfunction within 6 weeks of re... Read more
Patient hospitalized for bacteremia, severe sepsis with acute organ dysfunction within 6 weeks of receiving covid vaccination.
61 2021-01-03 lymph node swelling Small bowel obstruction with diffuse bowel and pelvic lymphadenopathy 36 hours after injection; Smal... Read more
Small bowel obstruction with diffuse bowel and pelvic lymphadenopathy 36 hours after injection; Small bowel obstruction with diffuse bowel and pelvic lymphadenopathy 36 hours after injection; This is a spontaneous report from a contactable physician (patient). A 61-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), intramuscularly on 21Dec2020 12:30 to at single dose on left arm for COVID-19 immunization in hospital. Medical history included crohn's disease. No known allergies. Concomitant medications within 2 weeks of vaccination included estradiol, progesterone, colestipol hydrochloride (COLESTID), ustekinumab (STELARA), cyanocobalamin (B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced small bowel obstruction with diffuse bowel and pelvic lymphadenopathy 36 hours after injection on 22Dec2020 22:00 with outcome of recovered in Dec2020. The adverse events resulted in emergency room/department or urgent care, hospitalization for 3 days. Therapeutic measures were taken as a result of event included inpatient observation, nothing by mouth (reported as NPO), intravenous fluids. No COVID prior vaccination, COVID test nasal swab was negative on 23Dec2020 post vaccination. It was not reported as serious.; Sender's Comments: There is not a reasonable possibility that reported events small bowel obstruction and lymphadenopathy are related to BNT162B2 vaccine. The patient had underlying Crohn's disease, which put patient at risk of developing the event. 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.
61 2021-01-06 lymph node swelling Immediately after receiving the vaccine, patient developed sensation of throat numbness in the back ... Read more
Immediately after receiving the vaccine, patient developed sensation of throat numbness in the back of the throat. Patient denied SOB, wheezing, throat swelling, stridor, rash, chest pain, tongue swelling. One dose of diphenhydramine 25 mg PO suspension and referred to the Mount Sinai emergency department. Sensation resolved after a total of 30 minutes (10 minutes after receiving diphenhydramine). Vital signs and physical exam were WNL with the exception bilateral submandibular adenopathy. Patient was observed in the ED for approximately one hour with no clinical change and was subsequently discharged home.
61 2021-01-07 lymph node swelling pain in her whole arm; numbness in right cheek/numbness in arm/hand; Swollen lymph nodes; This is a ... Read more
pain in her whole arm; numbness in right cheek/numbness in arm/hand; Swollen lymph nodes; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Dec2020 12:12 at SINGLE DOSE at right arm for covid-19 immunisation. Medical history included SVT this was recognized at least 20 years ago, around the age of 30, she started to deal with high blood pressure, allergic to penicillin. The patient's concomitant medications were not reported. The patient previously took codeine, levothyroxine: allergic to codeine, levothyroxine. The patient also previously took Tylenol with Codeine and that was horrible and she can't ever take it again, when she was around the age of 40 years old. The patient received the COVID vaccination around Wednesday 30Dec2020 at 12:12 p.m. She was perfectly fine until late Thursday afternoon 31Dec2020, around 3:30-4:00 pm. She started to have swollen lymph nodes. It was only a little bad at first and then she started getting more and more swelling. She spoke with her facility's RN who suggested she use some cold and warm packs/compresses and also take some Tylenol to deal with it. She has had the swelling for this many days now. It's not bad swelling but she her lymph nodes are still so swollen. She thought it was a regular reaction, but now it's been too long. Her lymph nodes are not swollen humongous. There is no redness. Her lymph nodes are not hard, just swollen. The swelling was a little bit better on Friday and Saturday but yesterday, it started bothering her again. She has had pain in her whole arm on an unspecified date. On 03Jan2020, her face also started to feel funny. She clarifies by "feeling funny", she meant she started to experience numbness in her right cheek, only her cheek, like when one gets a vaccination when they go to a doctor's office/dentist office and it starts working and one can feel it getting numb. She also experienced numbness in her arm. She clarifies when she puts pressure on her arm (like putting her arm on the desk), she feels numb in her hand. She verifies the numbness in both her cheek and arm started occurring on 03Jan2020 around 7-8pm. She is fine today and then she'll start to feel the numbness again in her cheek and arm. She clarifies the numbness comes and goes. It comes in the morning and then goes away and then the numbness starts again. She started to feel numb in her face and cheek, like when one gets a Novocain at the dentist office and it starts working- it's like the same feeling. The outcome of the events Swollen lymph nodes and numbness in right cheek/numbness in arm/hand was not recovered, while unknown for the other event. Information on the lot/Batch number has been requested.
61 2021-01-07 swelling face, swelling 1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after... Read more
1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after receiving the vaccine, at 2 PM started with itching of scalp, arms, legs, rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck. Took 50 mg Benadryl w/ some relief. 630 PM symptoms reoccur, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER at 830 PM
61 2021-01-10 lymph node pain, lymph node swelling Lymph node swelling under left arm and aching down left arm and side of chest. Lymph node painful to... Read more
Lymph node swelling under left arm and aching down left arm and side of chest. Lymph node painful to touch.
61 2021-01-10 lymph node swelling On 01/10/2021 started feeling Chills then 102.5 fever lasting 2 hours, took 2 Tylenol and fever went... Read more
On 01/10/2021 started feeling Chills then 102.5 fever lasting 2 hours, took 2 Tylenol and fever went down to normal. Later I realized that I had two swollen lymph nodes on the left side of my neck. Next morning 01/11/2021 at woke up noticed another swollen above the hollow of the clavicle.
61 2021-01-11 peripheral swelling fever; nausea; general feeling of unwell; soreness at site; redness; whole upper arm was swollen aft... Read more
fever; nausea; general feeling of unwell; soreness at site; redness; whole upper arm was swollen after the injection; This is a spontaneous report from a contactable other HCP (patient, Respiratory Therapist) reported that a 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , Batch/lot number: EJ1685) via an unspecified route of administration on 21Dec2020 around 6:00 PM in left upper arm at 0.3mL single dose for COVID Prevention. The patient's medical history was covid at the end of Apr/May2020 with shortness of breath, seasonal allergies and allergies to "some anitbiotics." The concomitant medications was reported as none, received no other vaccines on the same day as the COVID vaccine. The patient experienced soreness at site, redness and swelling, fever, nausea, general feeling of unwell 3 days. Patient stated, "I had covid at the end of April/May with shortness of breath. I thought I would have less reaction from the vaccine. I know someone who was out of work for a while week after the vaccine." States that she read that the 2nd dose is supposed to have worse side effects than the first. If she had bad side effects from the 1st dose, will the 2nd be worse? Also asking if the side effects are the immune system reacting or just an allergic reaction. Patient was anxious about getting her second COVID shot on 11Jan2021. Patient stated that she had all the side effects listed, for three days. Patient stated that she didn't mind the side effects at the time, she had fever, soreness at the injection site, nausea, and a general feeling of unwell, but Patient stated that she could not work like that. Patient stated that her question was, statistically she has read that the side effects from the second shot are supposed to be worse than the first shot, but she was wondering, if she had bad side effects from the first shot, will her side effects be worse after the second, or will they maybe be lessened because she already had bad side effects. Patient reported that she did fill out the VSafe significant because she had to work on the third day after her shot, which was Christmas Eve, and work, was so busy and she did not feel well. Patient stated that she does have two days scheduled off work after her next injection, but it is the third day that she was worried about because she does not want to work feeling like that. Patient stated that the arm soreness started that same day (21Dec2020). At first, Patient reported that the arm soreness resolved, but then she states that it is still a little sore to the touch. So Patient confirmed that it is ongoing but improved. Patient reportsed that the fever started the day after the injection, 22Dec2020 and it has resolved. Patient reported that the last day she recorded a fever was on 24Dec2020. Patient stated that she woke up on 24Dec2020 and her temperature was normal, so she went to work and she did not feel so well at work, but they were so busy that she barely noticed, and then when the Patient went home that night, she took her temperature and it was 100 degrees Fahrenheit. Patient reported that the nausea started on 22Dec2020, which was mild at times, but then she got to where she did not want to eat. Patient reported that the nausea has resolved but she was not entirely sure when it resolved because she had been so busy at work on 24Dec2020, and it was hard to tell what she was feeling because she was non-stop busy that day. Patient stated that she was nauseous for a full three days, and she remembered that she did not eat much on the 24th either. So Patient stated that her nausea may have resolved on the third day after her injection, but it is unknown to her what day exactly that it resolved. Patient was also experiencing the general feeling of unwell from 22Dec2020 for a few days, but stated that by 25Dec2020 she felt okay. Patient also included that her left arm was also swollen, like her whole upper arm was swollen after the injection in Dec2020. Patient stated that she also experienced redness, there was a like a red mark that was further down her arm than the injection site in Dec2020. The outcome of soreness at site was recovering. Patient confirmed that both the swelling and redness had resolved in Dec2020.The outcome of fever was recovered on 24Dec2020. The outcome of general feeling of unwell and nausea was recovered on 25Dec2020.
61 2021-01-12 lymph node swelling I have a swollen node in my Left Arm pit, the size of half of a tennis ball
61 2021-01-12 swelling face Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias o... Read more
Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias of both sides of lower face, lips and face swelling. This resolved in @ 20 minutes. Next day developed excessive fatigue with difficulty talking and a heavy sensation in the chaste with an event of fullness sensation of the right soft palate and tongue.. This became worse on the second day for which needed treatment with Medrol pack and antihistamins.
61 2021-01-13 anaphylactic reaction Systemic: Anaphylaxis-Severe, Systemic: Fainting, Systemic: Pharmacist submitting: unable to determi... Read more
Systemic: Anaphylaxis-Severe, Systemic: Fainting, Systemic: Pharmacist submitting: unable to determine if anaphalaxis or panic attack, patient experienced facial weakness, chest tightening, tremmors, inability to breathe, and fainting within 10 min of administ
61 2021-01-14 lymph node pain, peripheral swelling, swollen extremities, lymph node swelling Received the 2nd vaccine at 10am on 1/11/21 intramuscular in the right arm. At 3pm on the same day, ... Read more
Received the 2nd vaccine at 10am on 1/11/21 intramuscular in the right arm. At 3pm on the same day, I had a painful swolle lymph node on left side of neck. That same evening I developed pain, swelling, in my right armpit radiating to the right upper breast and down my right arm with a swollen lymph node under the right arm pit. The pain was about a number 7 on a scale of 1 to 10. The pain and swelling still persist today on 1/15/2021 Still painful, especially to touch. Still radiating down the arm. Lymph node still swollen The pain is about a 2 on a scale of 1 to 10
61 2021-01-15 peripheral swelling Total body rash with severe ankle and feet swelling and peeling that continues even after getting v... Read more
Total body rash with severe ankle and feet swelling and peeling that continues even after getting vaccine more than 3 weeks ago
61 2021-01-17 lymph node inflammation i1/13/21 at about 2;45 pm, I had my second Covid vaccination. had pain on site on left arm 1/14/21 ... Read more
i1/13/21 at about 2;45 pm, I had my second Covid vaccination. had pain on site on left arm 1/14/21 woke up feeling a little tired, went to work. went home early at 1:30 pm, feeling a little chilly. no fever. 1/15/21 in the morning noted pain on Left armpit ( injection site is left arm), pain from left shoulder blade to right shoulder blade. took advil. In the afternoon, about 4:00 pm, noted some swelling and soreness on left armpit. took Advil.. 1/16/21, Called employee health to report this. Advised to take advil and monitor and call pcp if symptoms persists.
61 2021-01-17 lymph node swelling Noticed early this morning a large swollen area above my left clavicle. This was about 36 hours aft... Read more
Noticed early this morning a large swollen area above my left clavicle. This was about 36 hours after my vaccination.
61 2021-01-17 peripheral swelling Hands are hurting, looks like I have some bleeding under the skin on my left hand, middle finger, ha... Read more
Hands are hurting, looks like I have some bleeding under the skin on my left hand, middle finger, hands are swollen and have a spotted look on the underside. Tried taking over counter meds, nothing is helping with pain.
61 2021-01-18 anaphylactic reaction tri-phasic anaphylaxis
61 2021-01-18 swelling face, swelling itching of scalp, arms, legs; rash; abdominal hives; facial swelling; difficulty swallowing; swellin... Read more
itching of scalp, arms, legs; rash; abdominal hives; facial swelling; difficulty swallowing; swelling back of neck; inj site very sore; fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK923) , via an unspecified route of administration on 29Dec2020 09:45 at the first single dose at arm left for covid-19 immunisation. Medical history included known allergies: Sulfa. The concomitant drug was unspecified. The patient previously took cipro and experienced drug hypersensitivity. On 29Dec2020, the patient expected side effect of inj site very sore and fatigue for 24 hours. On 06Jan2021 14:00, the patient started with itching of scalp, arms, legs ,rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck, took 50 mg Benadryl w some relief. 630 PM symptoms reoccurred, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of the back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER. The patient received Prednisone 50 mg orally and for the 4 days. The outcome of event inj site very sore and fatigue was recovered on 30Dec2020; the outcome of events was recovered.
61 2021-01-18 swelling face Systemic: 6 hours after vaccine lost voice, 8 hours after mouth, tongue, throat itching. next morni... Read more
Systemic: 6 hours after vaccine lost voice, 8 hours after mouth, tongue, throat itching. next morning had face and lip swelling and tingling. self treated with antihistamines. resolved after 3 days.
61 2021-01-18 swelling Chills, swelling, warm to touch , redness on the right arm inject site area and very itching
61 2021-01-18 swelling Patient's right side of neck starting swelling after 10-15 minutes of vaccination. Patient received ... Read more
Patient's right side of neck starting swelling after 10-15 minutes of vaccination. Patient received Benadryl and the swelling slowly went down. Patient stayed for another 20 minutes for watch and left.
61 2021-01-19 lymph node pain Painful lymph node in the arm where she had the vaccination and radiates to her breast
61 2021-01-19 lymph node swelling Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours... Read more
Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours after injection (I took 2 Tylenol and took a 3 hour nap) o Tired o Left Eye twitch o Blurred double vision o Headache o Nauseous ? Side Effects started about 5 - 6 hours after injection (I took 2 Tylenol a Benadryl and used my Ventolin inhalator) o Tired o Watering eyes o Sore tongue o Headache o Nauseous o Heavy feeling in chest ? Side Effects started some time during the night after injection o Muscle cramping in both legs and opposite arm of injection site o Low fever 100.3 Sunday side Effects (I took 2 Tylenol and took a 3-4 hour nap) o Tired o Left Eye twitch o Watering eyes o Sore tongue o Excessive thirst o Swollen neck glands o Nauseous (only after eating) o Muscle cramping in both calves o Blurry vision in the evening o Runny nose Monday side Effects (Went to work) o Tired o Left eye lid twitch o Swollen neck glands o Nauseous o Runny nose o Achy body o Diarrhea Tuesday side Effects (Went to work) o Left eyelid twitch o Swollen neck glands o Runny nose o Sore throat o Diarrhea BLOODY Wednesday side Effects (went to work) o Swollen neck glands o Runny nose o Sore throat Note: I have several Allergies that require me to take an allergy pill every day. I also use an inhaler as needed. My symptoms were not any worse than when I have a bad allergic reaction, I have received shots of Epinephrine for my allergies and did not feel one was necessary.
61 2021-01-24 c-reactive protein increased At day 20 after the vaccination I got up in the middle of the night & could barely walk. My knees we... Read more
At day 20 after the vaccination I got up in the middle of the night & could barely walk. My knees were very painful 10 out of 10. As the day progressed it got worse & I needed a walker & eventually a wheelchair.
61 2021-01-24 c-reactive protein increased On day 20 after the vaccination my knees starting getting sore- by 3 am I could barely stand on them... Read more
On day 20 after the vaccination my knees starting getting sore- by 3 am I could barely stand on them- as the day progressed I had to use a walker & by late afternoon a wheelchair. The pain in my knees was a 10 out of 10.
61 2021-01-24 lymph node swelling, lymph node pain Enlarged, sore lymph node right mid clavicle. 0.8mm; sore lymph node right mid clavicle. 0.8mm; This... Read more
Enlarged, sore lymph node right mid clavicle. 0.8mm; sore lymph node right mid clavicle. 0.8mm; This is Spontaneous report from a contactable Nurse (patient). A 61-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EL1238, intramuscular in arm right on 09Jan2021 13:00 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 on 19Dec2020 at 10:00 AM, lot number: EH9899, Intramuscular in arm left for covid-19 immunisation. The patient did not receive other vaccine in four weeks. The patient medical history was not reported. The patient did not have covid prior vaccination, and she was not tested for covid post vaccination. There were not known allergies. Concomitant medication included acetylsalicylic acid (ASPIRIN), and colecalciferol (VITAMIN D). The patient experienced enlarged, sore lymph node right mid clavicle. 0.8mm on 11Jan2021 18:00. The patient did not receive treatment. The outcome was not recovered.
61 2021-01-26 c-reactive protein increased unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffnes... Read more
unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment. 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.
61 2021-01-26 swollen extremities Monday afternoon, January 25, I started feeling achy and chilly. Just not well. I work 5 a.m. to 1... Read more
Monday afternoon, January 25, I started feeling achy and chilly. Just not well. I work 5 a.m. to 1:30 p.m. I went straight home from work. I took shoes off and got in bed. I was very cold and felt that the coldness was from inside out especially in my hands. I covered with a sheet and 3 blankets with an extra blanket to my feet and used winter gloves on my hands. I got up at 5 p.m and felt better. Tuesday morning, January 26 at 3 a.m. when I got up to shower, I noticed a soreness and large swelling under left armpit, ? lymphadenopathy. All others symptoms had passed. Continues to be the same on today, January 27. Seeing MD on Thursday, January 28.
61 2021-01-27 lymph node swelling 12/31/20:left a message saying she got the vaccine 5 days ago and is experiencing severe neck pain t... Read more
12/31/20:left a message saying she got the vaccine 5 days ago and is experiencing severe neck pain that shoots down her neck and back : saw PCP - f/u 1/8/21 :I still have a little neck pain left and my glands are still slightly swollen. Getting my 2nd dose today. I have paperwork from Pfizer that I need to fill out for their data keeping. Pain was excruciating for nearly 2wks and started to settle down a few days ago, where I don?t have to sit with a heating pad or take motrin and flexaril. f/u 1/28/21-"My neck still hurts, worse on certain days, but is bearable. I haven?t had any imaging done and just heard of another person with same symptoms. My 2nd dose was fine. No pain at all, not even at injection site. I will keep you posted if anything changes. I?m hoping it will just go away on it?s own. I?ve heard it takes months". Referred employee back to PCP.
61 2021-01-28 swelling day after shot. Woke up at 3:00 Am with severe pain in my right arm with redness and swelling around... Read more
day after shot. Woke up at 3:00 Am with severe pain in my right arm with redness and swelling around the shot area.
61 2021-01-31 lymph node pain, lymph node swelling Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness... Read more
Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness in arm, headache, and fever of 99.4 at about 2:30am on 1/18/2021. Side effects persisted all day on 1/18/2021 but relieved with acetaminophen 325mg every 6 hours. All side effects resolved by morning of 1/19/2021. Around 4:30pm on 1/19/21 started having pain in left axilla which was due to swollen lymph node. The pain and swelling progressed over the evening and pain radiated to chest, throughout left arm, and shoulder. All of these side effects continued all day on 1/20/21 but started getting better around 6pm. All side effects resolved by morning of 1/21/2021.
61 2021-01-31 swelling face Face swelling and redness. for 3 hours.
61 2021-02-02 lymph node swelling, lymph node pain Left gland/ Lymph node in armpit very swollen and painful. Headache and Fever
61 2021-02-03 lymph node pain, lymph node swelling Extremely painful enlarged lymph nodes under right arm. Remain painful 11days later. It is about the... Read more
Extremely painful enlarged lymph nodes under right arm. Remain painful 11days later. It is about the size of a baseball.
61 2021-02-07 swelling Angioedema
61 2021-02-07 lymph node swelling facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no it... Read more
facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no itching. Didn't notice until I left the vaccine site and was on the way home in car because covered by mask. Note I am a very fair skin, freckled red haired woman. I was very, very nervous and had gotten myself to the point of tears. Perhaps the flushing was from that. Have had similar flushing when drinking red wine. Swelling in lymph node in supraclavicular area on same side as shot. Has happened with Flu shot once. Slight fever for a short period of time and fatigue. I continue to have slight shortness of breath from having covid on. 4/3/20. Nothing different.
61 2021-02-07 lymph node swelling She had significant fatigue the day after the injection along with a sore arm and intermittent heada... Read more
She had significant fatigue the day after the injection along with a sore arm and intermittent headache. Starting about 72 hours after the vaccine she noticed a swollen lymph node at the base of her neck on the side of the injection. The lymph node, sore arm and intermittent headache are still present.
61 2021-02-09 lymphatic obstruction, lymph node swelling Fever,chills and uncontrollable shaking. Lymph nodes enlarged. Under layers of bedding and couldn't ... Read more
Fever,chills and uncontrollable shaking. Lymph nodes enlarged. Under layers of bedding and couldn't get warm. Fever got up to 102.5 on that Saturday about 25 hours after vaccine. Also, felt weak and very tired. Early Sunday morning about 2am, I woke up to my gown dripping wet from sweating. I changed went back to sleep and woke up again about 7am to the same thing. I did take Tylenol and Ibuprofen for the fever. I spent all Sunday in bed, no more shaking but chills and Fever persisted through out the day. Monday, I felt better initially until about 8 pm and symptoms started all over but harsher because know my Lymphedema flared up
61 2021-02-13 lymph node swelling 6:00 am next day woke with a really bad backache hard to walk or bend or pick up something. Felt li... Read more
6:00 am next day woke with a really bad backache hard to walk or bend or pick up something. Felt like that all day...very hard and stiff near back middle rib area both sides. Felt better if rested but if got up bad again. Very uncomfortable continued until the following morning. Got up today am 2/14 feel a lot better but slightly still there. Also had lymph node swelled a little in same arm as shot under collarbone. Hopefully my back isn't as bad as yesterday. Had to lay in bed a lot 2/13.
61 2021-02-13 lymph node swelling Wokke up around 3:00 a.m. 3 nights after vaccine. Violent vomiting 3-4 times, then diahhrea for abou... Read more
Wokke up around 3:00 a.m. 3 nights after vaccine. Violent vomiting 3-4 times, then diahhrea for about half hour. Thought I had food poisoning. Sever headache shortly after. Sunday, slight fever, listless, some muscle aches, joint pain. Sunday night, headaches returned. Monday, slight fever, muscle aches, swollen lymph nodes under right armpit. Some mild muscle aches and joint pain. Monday night, headache again. Tuesday, same symptoms. Wednesday, some joint pain, swollen lymph node, otherwise fine.
61 2021-02-14 lymph node swelling Severe all arm pain for short period of time, chills, headache, fatigue, swollen lymph nodes and con... Read more
Severe all arm pain for short period of time, chills, headache, fatigue, swollen lymph nodes and continuing nausea.
61 2021-02-16 swelling face Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101... Read more
Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101 - 2 days headache - 5 days nausea - still have diarrhea - 6 days Sore and stinging left arm (received vaccine), sore upper and lower back and neck. Felt like I was kicked in those areas - still have Fatigue - 6 days, lessening Toes bright red at the top and are painful, areas on bottom of toe as well - still have
61 2021-02-16 white blood cell count increased 61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief compl... Read more
61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine (Pfizer) on 1/28/21. Upon arrival to triage she was obviously dyspneic with significantly low oxygen saturations. O2 sats on arrival were 65%, improved to mid 90's with O2 6 liters per NC. Admitting diagnosis: hypoxic respiratory failure post COVID vaccine. Lab work shows an elevation of the BUN and creatinine at 31 and 1.71 which is slightly higher than her usual baseline levels. BNP is elevated at 2 448 with a mildly elevated troponin. Procalcitonin is also elevated. Patient's white blood cell count is 11.07. Full viral panel including COVID-19 is not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, Thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 2/8/2021 and then VV ECMO cannulation on 2/13/2021. EGD done 2/14/2021 as unable to pass the TEE probe during cannulation prior day (unable to complete due to abnormal anatomy). Acute pupil exam change in the early am hours of 2/15/2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. GOL engaged and patient not an organ donation candidate. Therefore discussion with sister at bedside resulted in decision for cessation of life support. Patient expired shortly after support withdrawn and pronounced dead on 2/15/2021 at 11:11 AM.
61 2021-02-19 swelling face Pt stated itchy and swelling face at the time of her first vaccine, She did not report this at the t... Read more
Pt stated itchy and swelling face at the time of her first vaccine, She did not report this at the time of the 1st dose and took benadryl when she returned home. Upon receipt of her 2nd dose, she notified the vaccinator, the medical OIC was notified. Benedryl was administered prior to onset of symptoms. Pt was instructed to be observed for 30 mins and observation was notified.
61 2021-02-22 lymph node swelling Swollen Lymph Nodes under left arm
61 2021-02-23 lymph node swelling Received first COVID vaccination at 3:50pm and 5-10 minutes later began to experience pain and throb... Read more
Received first COVID vaccination at 3:50pm and 5-10 minutes later began to experience pain and throbbing in jaw and lower molars. pain began moving forward. tongue began to tingle and mouth went numb. Glands were swollen and pain was experienced in both ears, under both eyes and cheek bones. Also experienced pain in the top and back of head.
61 2021-02-23 peripheral swelling Red circular swelling at injection site; forearm and wrist swollen, wrist itchy.
61 2021-02-24 lymph node swelling Woke up on 02/24/2021 with sweeling under the right arm (between armpit and breast). Swelling is sta... Read more
Woke up on 02/24/2021 with sweeling under the right arm (between armpit and breast). Swelling is stated to be the size of a softball in diameter. Client was asked to follow-up with her primary care physician.
61 2021-02-24 swelling, lymph node swelling Had my 2nd vaccine 1/28/21. On 2/3/28, I has rashes, redness & itchiness upper chest. On 2/5/21, My ... Read more
Had my 2nd vaccine 1/28/21. On 2/3/28, I has rashes, redness & itchiness upper chest. On 2/5/21, My lymph nodes right neck is swollen, also painful mass around 2x3cm below right clavicle near the sternum. I also have flu-like symptoms, body weakness especially lower extremities. Rashes and itchiness upper chest still present. 2/9/21 : Lymph node swelling of right neck & below right scapula still present. Rashes & itchiness upper chest still present but controlled with hydroxyzine tablet. Flu-like symptoms still present. 2/11/21: Rashes & itchiness minimal, less medication needed. Lymph node swelling less, still gets tired easily. 2/19/21: lymph node below right clavicle bigger for 1 day. No more lymph node swelling right neck. Still gets tired easily. 2/24/2021: Lymph node below right clavicle 1x1 in size, not painful.
61 2021-02-25 white blood cell count increased [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)
61 2021-02-27 swelling face Pain at the injection site was typical for vaccination and was essentially gone by the next day. Hea... Read more
Pain at the injection site was typical for vaccination and was essentially gone by the next day. Headache started within one hour after vaccination and was severe 4 hours after vaccination. Next day morning I woke up with all my face swollen, runny nose, headache, stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year and dizziness. Face edema and runny nose subsided 3 days after injection. Stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year persists 7 days after injection. Dizziness and foggy head became worth 7 days after injection.
61 2021-03-01 swelling face Moderate fatigue - unresolved mild headache - unresolved diarrhea - resolved 2/19/2021 joint pain - ... Read more
Moderate fatigue - unresolved mild headache - unresolved diarrhea - resolved 2/19/2021 joint pain - resolved 2/22/21 increased blood pressure - resolved 2/19/2021 swollen eye lids and upper checks - resolved 2/22/2021
61 2021-03-03 swelling face numbness in her lips; swelling in her face; her tongue was feeling funny; her throat was feeling str... Read more
numbness in her lips; swelling in her face; her tongue was feeling funny; her throat was feeling strange; she had itchiness to her right hand; started to develop hives; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 01Feb2021 at 09:00 (at the age of 61-years-old) at 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 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. The patient experienced numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, she had itchiness to her right hand, and started to develop hives on 01Feb2021. The clinical course was reported as follows: Approximately 3 hours after receiving the vaccine, the patient started to experience numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, and she had itchiness to her right hand and started to develop hives. The patient stated that she cannot take diphenhydramine hydrochloride (BENADRYL), but she did take cetirizine hydrochloride (ZYRTEC) to help with the symptoms. The patient was still having symptoms at the time of reporting. Therapeutic measures were taken as a result of all of the events as aforementioned. The clinical outcome of numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, she had itchiness to her right hand, and started to develop hives was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
61 2021-03-04 peripheral swelling Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly reso... Read more
Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly resolved some memory issues and headache still 2 days later
61 2021-03-06 fluid retention On day 2, I developed confusion and could not focus making it impossible for me to complete my work ... Read more
On day 2, I developed confusion and could not focus making it impossible for me to complete my work at my job. The confusion made driving dangerous. By Friday, I went to my PCP and they noticed that my blood pressure was only 90/58 and they were concerned so she told me that she was calling my cardiologist who said to reduce the dose of my Diltiazem from 180 mg daily to 120 mg daily. She also said to take a few days off of taking the Diltiazem. I have also had a serious increase in Tachycardia. That evening I went to the ED because I was so weak and couldn't breath well. I am also retaining a lot of fluid. The lab work indicated an elevated Pro-B-Natriuretic Peptide level of 227. I am still not well and each doctor I have spoken to said they believe it is due to the vaccine. I do not know if I should take the second dose.
61 2021-03-06 swelling face At 0900 this morning my face next to the right side of my mouth started itching. I immediately felt ... Read more
At 0900 this morning my face next to the right side of my mouth started itching. I immediately felt it swell. I looked in the mirror and could see the left lower part of my face (lower cheek by the edge of my mouth) swell and my right upper lip started to swell. I took a Benadryl (25mg oral tablet) and my roommate drove me to the Emergency Room. That area of my face continued to swell and impacted my lower lip as well. My lips were numb and tingling and I could feel my cheek swell more inside my mouth as it was touching my teeth. I was monitored (vital signs and pulse ox) for 90 minutes and received 20 mg of pepcid oral tablet and 10 mg dexamethasone oral tablet- both 1x only.
61 2021-03-07 lymph node swelling arm soreness at injection site (both vaccines); fever <100.6F x 24 hours; delayed headache x 3 days;... Read more
arm soreness at injection site (both vaccines); fever <100.6F x 24 hours; delayed headache x 3 days; enlarged left breast lymph nodes; This is a spontaneous report from a contactable health care professional (patient) reported for herself. A 61-year-old non-pregnant female patient (Patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL0140, expiry date: unknown) via an Intramuscular on 28Dec2020 at 12:00 PM (at the age of 61-years-old) on Left arm at single dose and second dose (lot number; EL0142, expiry date: unknown) via an intramuscular route on 19Jan2021, at 08:30 AM on left arm at single dose; both for COVID-19 immunization. Medical history included hypothyroidism and hyperlipidemia. Patient received unspecified concomitant medications (Other medications the patient received within 2 weeks of vaccination (unspecified)). Patient had no Allergies to medications, food, or other products. On an unknown date, the patient had arm soreness at injection site (both vaccines); on 20Jan2021, at 05:00 am, patient had fever less than 100.6 F x 24 hours, delayed headache x 3 days for 3 days, enlarged left breast lymph nodes (routine mammogram/sonogram was 2 days post injecting on left arm). No treatment was received for the adverse 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. Since the vaccination, the patient has been tested for COVID-19. On 25Jan2021, patient underwent nasal swab (SARS-COV-2-BY-NAAT) test and resulted as negative. Seriousness of the events was reported as non-serious. Outcome of the events was recovered on an unknown date in Jan2021.
61 2021-03-07 peripheral swelling swelling and muscle pain in rt arm
61 2021-03-10 peripheral swelling I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was... Read more
I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was as if the effects of my infusions were cancelled. Extreme widespread stiffness, pain, joint swelling and heat, muscle weakness and pain. I also had swollen lower lip and have had an increase in headaches and nausea. Two weeks after the injection I awoke with my right arm swollen, hard, and itchy. The arm and my lips have resolved, but I am still having all the other problems. I have reported these symptoms to both my primary doctor and my rheumatologist.
61 2021-03-12 peripheral swelling Received Pfizer vaccine at the Hospital on March 12, 2021 at 10:05 a.m. No reaction at that time. O... Read more
Received Pfizer vaccine at the Hospital on March 12, 2021 at 10:05 a.m. No reaction at that time. One hour later my ears and scalp began to itch. I had chills and severe nausea. Severe stomach cramping. Rash covering arms, legs, scalp, back and shoulders, Hives across chest and down both arms. Swelling and hives on palms of hands. Difficulty breathing. Symptoms began one hour after vaccine and continued to worsen. Was treated at Center for allergic reaction. Was given Benedryl and Famotadine, then released.
61 2021-03-13 lymph node swelling Around 12;00pm on 3/13 , I felt muscle aches through back, shoulders, neck. Sore at site of vaccin... Read more
Around 12;00pm on 3/13 , I felt muscle aches through back, shoulders, neck. Sore at site of vaccine and Headache. I felt tired and rested around 1:00p.m. Took 1 extra Strength Tylenol. Then started getting chills. Felt like I had swollen lymph node on ride side of throat when swallowing and had some pain going up into my ride ear. These symptoms lasted all evening. I didn't feel like eating dinner so rested and took 2 extra strength Tylenol at 9:00 p.m. and went to bed. Woke up early in morning with bad headache so I took another 2 extra strength Tylenol around 6:00am. I finally started feeling better around 9:00am.
61 2021-03-13 swelling Redness, flushing, swelling
61 2021-03-14 peripheral swelling Had severe headache, chills, fever, whole body aches, joint pain, swollen arm, very hard lump and ho... Read more
Had severe headache, chills, fever, whole body aches, joint pain, swollen arm, very hard lump and hot at injection site. All this started the day after injection .so severe that it felt like I had covid AGAIN! Couldnt eat or hardly get out of bed the day after shot and the second day after the shot I still felt the same but was able to eat . The third day after shot, my fever went away and most of the body aches except I still have the headache and my arm is still hot, and swollen. Just have been taking tylenol this whole time and cold wash cloth for fever and swelling.
61 2021-03-15 lymph node swelling A lump developed in the area between my shoulder and neck on the same side as the vaccine was given.... Read more
A lump developed in the area between my shoulder and neck on the same side as the vaccine was given. Information provided with vaccine provided a link which after review makes me think this lump is a swollen lymph node.
61 2021-03-15 swelling face Within minutes of getting the shot in my left arm I started to feel the left side of my neck getting... Read more
Within minutes of getting the shot in my left arm I started to feel the left side of my neck getting stiff. It felt like the stiffness was creeping up my neck. After about a hour I felt my ear lobes tingling and the left side of my face in the jaw area seemed a bit swollen and felt a little numb. It resolved and I had only a sore injection site the next day and no other symptoms. I'm wondering if I should be concerned about getting the second shot
61 2021-03-15 swelling face Swelling around eye Face is slightly swollen Soreness at infection site
61 2021-03-16 peripheral swelling Pt called clinic stating that 12 hours after getting vaccine she noticed swelling of left breast and... Read more
Pt called clinic stating that 12 hours after getting vaccine she noticed swelling of left breast and left arm. States that left breast noticeably bigger that the right. Almost double the size from the swelling. Left arm having swelling that started on the inner aspect of the upper arm and has spread down to the elbow. Stated it is tender to the touch and having pain in muscle with moving arm. Not hot to touch. No redness, rash, bruising, shortness of breath, or tightness in throat. Offered an appointment for evaluation at the clinic, but patient declined and preferred to continue to monitor at home. Discussed that if swelling increases or persist to contact the clinic fo an appointment.
61 2021-03-17 lymph node pain, lymph node swelling Swollen and tender axillary lymph node Narrative: Patient received her second COVID vaccine on 3/9... Read more
Swollen and tender axillary lymph node Narrative: Patient received her second COVID vaccine on 3/9/2021 in her left deltoid. On 3/11, patient called the facility to report a "swollen lump" in her left axila, which she had noticed that day (two days post-vaccine). She additionally reported the area to be tender to palpation. The area was slightly warm, but not hot. She denied drainage or fever. She denied any other symptoms other than increased fatigue since vaccine. On 3/16, patient contacted the facility again to relay that her post-vaccine symptoms had resolved. She reported her affected lymph node was still slightly swollen but much improved from initial onset.
61 2021-03-17 swelling bruise to her back; rash on back of neck/rash all over her body; redness; swollen area back of neck/... Read more
bruise to her back; rash on back of neck/rash all over her body; redness; swollen area back of neck/ swollen area to her back; a lot itchier; This is a spontaneous report from a contactable Nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via intramuscular on left deltoid on 21Jan2021 at 14:00 at single dose to prevent Covid 19. The relevant medical history included obese from an unspecified date. Concomitant medications were reported as none. The patient experienced rash on back of neck/rash all over her body on 26Jan2021 at 19:30, swollen area back of neck/ swollen area to her back on 26Jan2021 at 10:00, redness on 26Jan2021 at 19:30, bruise to her back on 27Jan2021 at 10:00, a lot itchier in Jan2021. The nurse stated that she wanted to report that she had the Pfizer vaccine last Thursday. Stated that two days prior to the report that a rash started on the back of her neck and stated yesterday it was a lot itchier (as reported). Stated that she got undressed to put her PJs on and noticed that she had a fine raised rash everywhere and it was swollen. Stated that she went through her house to see if there was anything that could have caused it. Stated that she went to that doctor at the time of the report and was started on Prednisone taper. Stated that the doctor was concerned about the Prednisone reducing her ability to prevent antibodies. Stated that the doctor stated that he was unsure if she should get the second dose. Caller wanted to ask questions about these things. Had not started the Prednisone yet. Stated that there was redness to the back of her neck and back. Stated that the swelling was to the back of her neck and back. The events did not require a visit to Emergency Room but required a visit to Physician Office. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The event bruise to her back was reported as non-serious, while the events rash on back of neck/rash all over her body, swollen area back of neck/ swollen area to her back and redness were reported as serious due to medically significant. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "rash on back of neck/rash all over her body", "swollen area back of neck/ swollen area to her back and redness" and the administration of the COVID-19 vaccine, BNT162B2, based on the plausible temporal association and lacking alternative explanations. 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.
61 2021-03-18 lymph node swelling 1. Started Mar 8: Swollen lymph nodes on the right side behind the ear and at the root of sculp. ... Read more
1. Started Mar 8: Swollen lymph nodes on the right side behind the ear and at the root of sculp. Painful, in 4 days started fading away, in 6 days no pain , in 9 days completely gone. 2. started Mar 9: High Blood pressure - 167/97; was taken Amlodipine ( 2*2.5 mg); in 4 days it stabilized. 3. started Mar 14: Fever, treated with Tylenol taking every 6-8 hours. on Mar 19 temp is normal. 4. on Mar 18 Dr. took blood and urine tests. No sings of any abnormality. Came to conclusion - should be vaccine side-effect, report to.
61 2021-03-20 lymph node swelling Chills; Fever; Pounding headache; Swollen lymph nodes on left side; This is a spontaneous report fro... Read more
Chills; Fever; Pounding headache; Swollen lymph nodes on left side; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 09:45 AM (Batch/Lot Number: EL3247), at the age of 61-year-old at the time of vaccination, as SINGLE DOSE for covid-19 immunisation . Medical history included chronic lymphocytic leukaemia (CLL) and former breast cancer. Concomitant medication included tamoxifen 20 mg taken for an unspecified indication, start and stop date were not reported. The patient received dose 1 of vaccine on 15Jan2021 01:00 PM at left arm, lot number: EL1283. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. On 05Feb2021 22:00, the patient experienced chills, fever, pounding headache, swollen lymph nodes on left side. The outcome of the events was recovered. The patient took Tylenol as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19.
61 2021-03-21 swelling face Patient DOB 5/16/1959 received 1st dose of Pfizer Lot # ER8730 and was waiting in the 15 minute obse... Read more
Patient DOB 5/16/1959 received 1st dose of Pfizer Lot # ER8730 and was waiting in the 15 minute observation section when she stated that she felt "swelling of her face and tingling of her lips." Blood pressure was 196/98, HR 85, O2 97%, Temp 98.1. Patient was alert and oriented x 4. Patient stated that she was very anxious today and has allergies to dairy and pollen. Patient confirmed that her husband was on the way to pick her up and drive her home. EMT administered 25 mg of Benadryl PO at 12:32 pm. Patient observed for an additional 50 minutes until her husband arrived to pick her up at 1:22 p.m. Patient stated that she was feeling better and was able to walk unassisted with her husband. informed patient to go to ER or call 911 if symptoms worsen.
61 2021-03-21 swelling face Face Swelling, lips swelling, felt like inside of mouth was thickening. Called doctors office and s... Read more
Face Swelling, lips swelling, felt like inside of mouth was thickening. Called doctors office and spoke to oncall doctor. He recommended to take antihistamine. On way home -stopped at gas station and got Benadryl. Took Benadryl twice Saturday and Sunday. Had cold chills and sweating Sunday night. Stomach pain and diarrhea Monday.
61 2021-03-21 swelling Rash on my abdomen and arms started about 5 days after the vaccine. Rash is itchy and looks like ra... Read more
Rash on my abdomen and arms started about 5 days after the vaccine. Rash is itchy and looks like raised bug bites. Itching mostly at night. Will break out in different areas on arms from day to day. Abdominal rash remains constant. Started using OTC cortisone to minimize the itch and started taking Zyrtec for the itch. It still remains as of this report and hasn't gotten any better.
61 2021-03-22 lymph node pain, lymph node swelling Around 11, 11:30 the pain woke me up because it was so bad. It was hot and there was a big lump unde... Read more
Around 11, 11:30 the pain woke me up because it was so bad. It was hot and there was a big lump under my left arm pit (was very tender). I did not go to sleep like that. I did not have any symptoms by the time I went to bed. I also felt hot, and then cold, then hot, then cold, I would feel too hot and then too cold, freezing, I could not keep my temperature under control. I had to call in at work during the weekend I was feeling so bad. I had a lump under my armpit the size of a fist and I could not close my arm completely. It was huge and painful. I decided to go to a clinic over the weekend (unsure if Saturday or Sunday) to seek medical care and they ran some labs and a CBC to check for infection. All results came well no infection. They suggest to keep taking Tylenol. By Monday or Tuesday I started feeling well enough to return to work. The lump was still present and took about a week to go down. The injection site also was sore for a while, about a week also like the lump.
61 2021-03-22 swelling Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was nor... Read more
Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was normal and thought I might feel flying for a bit but that it would wear off so I did not report feeling anything at the clinic. I left the clinic and got in the car to drive home and felt a weird feeling in my throat reminiscent of my esophageal spasm and then it felt like someone had their hand on my throat squeezing my throat and felt like I needed to take deep breaths to expand my lungs. Within a minute or two at most, my lips, tip of my tongue, tip of my nose and face beside my lips and under my cheeks started to tingle and go numb. My insides felt swollen. I had a doctors appointment and went there after picking my son up at home. I reported my feeling to my doctor who prescribed a steroid for 3 days and told me to also take Benadryl or Claritin, which I did. However, today is day 4 after my vaccine and today is the first day my insides don?t hurt.
61 2021-03-23 lymph node swelling I had swollen and very, very painful - the muscle on top of my shoulder (Trapezius) on the right sid... Read more
I had swollen and very, very painful - the muscle on top of my shoulder (Trapezius) on the right side and I took Advil late at night time because it was so painful I couldn't sleep. My arm was not sore but that muscle was. That seemed to calm it down (Advil). The next morning, I was very swollen under my right armpit - I figured it was my lymph node. It was uncomfortable and very noticeable - quite swollen for three days. It took about a week to go back to normal. I also had abnormal fatigue and that took longer to resolve - that took about two weeks to be resolved.
61 2021-03-24 lymph node swelling On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 10... Read more
On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 102. On 3/22/21 and continue to have swelling in my left armpit (Lymph node area), spasms in my left shoulder blade and surrounding soft tissue adjacent to my left armpit and neck area. I have experienced soreness in that arm/shoulder but not at the injection site - overall bicep and clavicle area. I have been able to alleviate symptoms to a degree by taking a tylenol once or twice a day but the pain is limiting some of my daily activities to a degree.
61 2021-03-24 peripheral swelling Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tigh... Read more
Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tightening of chest every so often; acid reflux; hot flashes; sweating; stomach aches; upper abdominal pain radiating to back; severe fatigue; Dizzy/dizziness; stomach feels odd; Headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6198), via an unspecified route of administration, administered in upper left arm on 25Feb2021 9:00 (at the age of 61-year-old) as single dose for virus (COVID-19 immunisation). Medical history included chronic pain, pancreatitis, allergic to medications, old injury in her right arm, menopause and an ongoing mass in parotid lobe discovered in 2019 with CT scan. MRI performed in Mar2020 and CT scan in Oct2020. She stated that they are just watching it because it has not changed. Well defined borders are present, caller stated that doctor was unconcerned. Her mother had heart disease. Ongoing concomitant medications included ibuprofen for chronic pain and gabapentin from 2019 for chronic pain. The patient also took unspecified medication for pancreatitis. She has taken all kinds of stuff after pancreatitis but they do not work. The patient got deadly ill from the flu shot. Unsure of onset age, vaccine/brand name, or vaccination date. She stated that it was before 2003, possibly in the late 1990's or early 2000's. The patient had no history of all previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. On unspecified date the patient experienced diabetes; on 25Feb2021, the patient experienced dizzy, stomach feels odd, hot flashes, severe fatigue, sweating, stomach aches, acid reflux, upper abdominal pain radiating to back; on 26Feb2021 she experienced tightening of chest every so often; and in Feb2021, she had headache. It was further reported as follows: The patient stated that she took the Pfizer shot, clarified that she received the Covid-19 vaccine, on 25Feb2021, not quite 2 weeks ago. She stated that she had a little bit of a reaction after receiving the vaccination while there, so they were monitoring her. She has been experiencing hot flashes, sweating, and stomach aches for 2 days. She cannot get rid of hot flashes and that she has not had a hot flash in 2 years. She states that she has been down for 2 days with fatigue, that it's really bad. She is inquiring if the side effects that she is experiencing are common side effects and if it is ok to get 2nd shot. Her second vaccine is scheduled for 17Mar2021. She stated that she wanted to take the time to make a report as she is allergic to medications. While inquiring about dates of vaccines and side effects, she stated that she was experiencing tightening of chest every so often. She stated that she only had a few days of stomach pain and she has not stopped eating. She is unable to concentrate (unspecified date) and she has been experiencing headaches, experiencing them twice in 2 weeks. She also reported that she has been having upper abdominal pain radiating to her back. This concerns her, every time she gets it, it scares her. She had pancreatitis when she was 36. It is a nightmare thought. Does this sound like maybe she is possibly starting Diabetes? She reported that this shot has triggered everything. She has an old injury in her right arm. Her arm is killing her, her hands are swelled up, she has acid reflux again, she felt terrible. She stated that the dizziness not as strong as it was at the beginning. The fatigue it comes and goes and that she has spurts where she is energetic. She stated that it's more on than off. She is no longer having stomach aches. She compared the pain to pains of constipation. She also stated that she was constipated after receiving the vaccine on unspecified date. She had nausea at the beginning. The tightening of chest happened off and on, the last day that she experienced tightening of chest was on Sunday. For acid reflux, she is taking Zegerid as treatment, 20mg 20 mg capsules by mouth once daily as needed. She started this on 02Mar2021. She experienced upper abdominal pain yesterday and some this morning, but it was mostly in her back this morning. Her Sweating is off and on. She experienced headache just a couple of times but that she has not had one in a while. She stated that they lasted only an hour or two, and that she does not usually get headaches. She suggested that these may be due to sinuses and weather change. She has been taking Ibuprofen twice a day as treatment. But she normally takes Ibuprofen for chronic pain. Supposed to be 3 times a day but she does not want to take that much. She stated that all of this could also be stress related and that this could also be menopause. The patient recovered from stomach aches on 02Mar2021. The outcome of the events dizzy, sweating, tightening of chest every so often, upper abdominal pain radiating to back, headache was recovering; the outcome of stomach feels odd, hot flashes, severe fatigue, acid reflux was not recovered. The outcome of the remaining events was unknown.
61 2021-03-24 swelling Red, swollen circle approximately 2 inches in diameter with rash
61 2021-03-25 anaphylactic reaction Pasting clinicians note below: Patient is 61 year old female with hx of anaphylaxis presenting for C... Read more
Pasting clinicians note below: Patient is 61 year old female with hx of anaphylaxis presenting for Covid-19 vaccine, Dose #1. She developed itching in there throat within 30 minute waiting period. She was taken to Rapid Response Room. Symptoms progressed from itchy throat, to congestion in throat/upper chest, clearing her throat, watery eyes. Then dry cough. No nausea, no vomiting, no light headed feeling. No facial swelling No hives. OBJECTIVE: Vitals - 154/97, 105, 100%RA Neck - Supraclavicular mild retractions, end inspiratory stridor CV: tachy, regular, no murmur pulm - diminished breathe sounds throughout, no wheezing. Speaking full sentences. Assessment/ Plan: Anaphylaxis to Covid-19 Vaccine: - emergency responders - epi 0.3 mg IM administered to L mid outer thigh at 9:35 am by me - epi 0.3 mg IM administered to R mid outer thigh at 9:41 am because symptoms not subsiding by me -benadryl 50 mg IM x 1 L deltoid by RN 9:45 am - Itching in throat subsided but still retracting and clearing throat so albuterol 3 puffs given at 9:50 am Vitals stable entire time (see midas report) EMS arrived to transport to local hospital.
61 2021-03-25 peripheral swelling 3 days after completing vaccine series, pt develop right leg pain and swelling, which progressed lat... Read more
3 days after completing vaccine series, pt develop right leg pain and swelling, which progressed later on to shortness of breath after a week.
61 2021-03-25 swelling Sore arm for about 3 days. Then a week later I suddenly got cold hands, legs, stiff neck, swollen he... Read more
Sore arm for about 3 days. Then a week later I suddenly got cold hands, legs, stiff neck, swollen head, dizzy, multiple bowel movements, week leg muscles, tired. Lasted about 1 hour for initial wave, then was tired and out of commission for about 3 hours afterwards.
61 2021-03-26 anaphylactic reaction Severe itching all over, anaphylactic, took two allergy pills and medical test on music related to t... Read more
Severe itching all over, anaphylactic, took two allergy pills and medical test on music related to the nostril shot of Flonase
61 2021-03-27 anaphylactic reaction Anaphylactic Redness Asthma
61 2021-03-27 lymph node swelling Pain Lymph node inflammation Fever Aching Resolution after 3 days
61 2021-03-28 lymph node swelling After receiving the vaccine on Saturday afternoon, the right arm started hurting(normal side effect)... Read more
After receiving the vaccine on Saturday afternoon, the right arm started hurting(normal side effect) but by late Sunday afternoon (24 hours later) the lymph nodes in my right armpit started swelling. The size of a plum as of Monday afternoon. (48 hours)
61 2021-03-29 lymph node swelling Fever (103°) chills and body aches lasting 28 hours, (RESOLVED) swollen lymphnodes armpit has (NOT... Read more
Fever (103°) chills and body aches lasting 28 hours, (RESOLVED) swollen lymphnodes armpit has (NOT RESOLVED)
61 2021-03-29 oral herpes Lips were red and sunburned like with pain. Following day, fever blisters broke out. (common when... Read more
Lips were red and sunburned like with pain. Following day, fever blisters broke out. (common when my lips get sunburned). Treated with Carmex at onset and they went away in a couple days, fairly quickly.
61 2021-03-29 peripheral swelling, axillary mass Fever, headache, aching neck, arms and hands. Fingers felt stiff and swollen, hard to move, but stil... Read more
Fever, headache, aching neck, arms and hands. Fingers felt stiff and swollen, hard to move, but still looked normal size. Developed an egg size lump under left armpit that was very painful.
61 2021-03-29 peripheral swelling Pt c/o tingling, swelling in right arm, distal edema noted (mild; no SOB, rash, or hives. Benadryl ... Read more
Pt c/o tingling, swelling in right arm, distal edema noted (mild; no SOB, rash, or hives. Benadryl 25 mg PO @1020; 1030 Edema improving, no other s/s. Pt states B/P is normal for her. Pt stayed 1 hour past injection. Edema resolving. Staqtes feeling much better. Tingling resolved. B/PP 100/60.
61 2021-03-29 peripheral swelling Dizzy about an hour later. Worked through it. Itching/swelling as in first dose in arm but handled w... Read more
Dizzy about an hour later. Worked through it. Itching/swelling as in first dose in arm but handled with anti-itch sprays and cremes. In afternoon, nauseated and dry heaves. After 9:00PM, high fever, aches, constant chills throughout the night. Extreme thirst. Fever through the next day and used a COVID sick day. Symptoms gone by morning of 03/27/2021.
61 2021-03-29 swelling Once injection given, felt like Electric shock immediately afterwards, bleed a little, area swelled,... Read more
Once injection given, felt like Electric shock immediately afterwards, bleed a little, area swelled, painful and turned a purple /black. The next day my neck, shoulder and area where injected swelled and painful. Muscles aches all over. After about 3-4 days leg muscles stopped hurting but muscles in left arm continue to be bothersome, from my shoulder down to my thumb muscle spasms throughout the day. To this day 3/29/21 I continue to have muscle spasms from my shoulder down my left arm.
61 2021-03-30 lymph node swelling chills; injection site pain; headache; muscle pain; fever/tiny fever; impacted lymph nodes/lymph nod... Read more
chills; injection site pain; headache; muscle pain; fever/tiny fever; impacted lymph nodes/lymph nodes are impacted a little bit; nausea/feeling nauseous; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6206) via an unspecified route of administration, administered in Arm Left (left shoulder), at the age of 61-year-old, on 03Mar2021 19:00, as SINGLE DOSE for covid-19 immunisation. The patient medical history was overweight, diagnosed COVID last Apr2020 she had it for 17 days and had every symptoms. The patient tried to give antibodies for many months and she was told she had two different kinds of antibodies which prevented her from doing that. The patient has long hauler symptoms which are nerve pain in her thighs and mouth. The patient's concomitant included an unspecified medication (she takes something but not relevant). The patient did not receive any vaccine within 4 weeks prior. The patient previously received shingles vaccine on 14Feb2020 and tetanus shot on an unspecified date (years ago) both given for immunization and her arm hurt/ pain at the injection site (if she touches it, it hurts). On 03Mar2021 at 7PM, after receiving first dose, she felt blah described as she developed injection site pain which is dissipating but still there, headache, muscle pain, tiny fever, impacted lymph nodes, nausea/ feeling nauseous which she didn't have before. The patient can get up and walk around. On 04Mar2021, the patient had chills in the afternoon. It was just a little fever. The patient took Tylenol and Advil in the afternoon and it helped it go away. The patient took one of each. It was reported that the COVID headache is like none other and she had the headache again. For the COVID headache if you take things it doesn't make it go away. When the patient said she had the headache again she meant she had the same headache that she had in April. The events did not require ER or physician office visit. Outcome of injection site pain was not recovered while it was unknown for the other events. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.
61 2021-03-30 lymph node swelling Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appet... Read more
Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible, No further information available
61 2021-03-30 peripheral swelling Uncontrollable chills for 4 hours until I fell asleep followed the next day by painful swelling unde... Read more
Uncontrollable chills for 4 hours until I fell asleep followed the next day by painful swelling under the left arm.
61 2021-03-30 swelling Very painful lump in fat tissue starting next morning. Red spot starting that evening, gradually gro... Read more
Very painful lump in fat tissue starting next morning. Red spot starting that evening, gradually growing for 4 days. Hot, hard lump and redness still present after 5 days. No irritation/ pain in muscle at all this time. Lump and pain localized in fat tissue only.
61 2021-03-31 lymph node swelling, lymph node pain I have had symptoms that mimic Breast Cancer Nipple discarge Nipple redness Lymph Node Pain Swellin... Read more
I have had symptoms that mimic Breast Cancer Nipple discarge Nipple redness Lymph Node Pain Swelling Discomfort
61 2021-03-31 lymph node swelling Swelling/discomfort in armpit of arm corresponding with covid vaccine injection. Although swelling... Read more
Swelling/discomfort in armpit of arm corresponding with covid vaccine injection. Although swelling/discomfort continues, it is lessening with time.
61 2021-04-01 pancreatitis Severe abdominal pain, leading to ER visit and diagnosed with Pancreatitis. Severe pain started 30 m... Read more
Severe abdominal pain, leading to ER visit and diagnosed with Pancreatitis. Severe pain started 30 minutes after the vaccination.
61 2021-04-01 swelling face Face swelled almost double in size. Severe headache very fast heart rate nausea diarrhea about 3-4 ... Read more
Face swelled almost double in size. Severe headache very fast heart rate nausea diarrhea about 3-4 minutes after leaving the vaccine site. Symptoms begin to decrease then stop within 5 minutes. Face remained somewhat swollen for about an hour. Headache remained for about 6 hours then arm hurt for about 6 hours. Diarrhea remained for 24 hours
61 2021-04-01 swelling Woozy, felt like body was swelling, then numb, then tingling, then like a rag doll. Headache, nauseo... Read more
Woozy, felt like body was swelling, then numb, then tingling, then like a rag doll. Headache, nauseous. Red rash all over face. Very fatigued. Most of it lasted all day.. Next day, Friday, still very fatigued and a slight headache that comes and goes. Everything else was gone. Had no problems with breathing. No fever. Had no treatment.
61 2021-04-01 swelling on 4/1/2021 my left clavicle was very sore. then noticed it was swollen - looks like lymph nodes. ... Read more
on 4/1/2021 my left clavicle was very sore. then noticed it was swollen - looks like lymph nodes. praying & hoping it will go away. other than that, slight headache nite of shot & day after (4/1) was also extremely tired. i did have the covid on 12/9 & it turned into pneumonia.
61 2021-04-02 lymph node swelling Fever, fatigue, headache, full-body aches, swollen glands
61 2021-04-03 swelling development of rash on both arms, torso, side of face, right hand - redness, swelling, terrible itc... Read more
development of rash on both arms, torso, side of face, right hand - redness, swelling, terrible itching
61 2021-04-05 swelling face Her face started swelling and turned red and her throat felt tight.. She was given .3 cc of epineph... Read more
Her face started swelling and turned red and her throat felt tight.. She was given .3 cc of epinephrine . She felt better then we had to repeat the dose in about 15 more minutes. She could still breath easily but she did not feel better after the second epinephrine shot. She was sent to the ER in an ambulance
61 2021-04-06 lymph node swelling Complained of swollen glands, difficulty swallowing and had pursed lip breathing. Vitals= 140/83, Pu... Read more
Complained of swollen glands, difficulty swallowing and had pursed lip breathing. Vitals= 140/83, Pulse= 69, no O2 obtained. 2nd set of vitals= 136/71, P 67. Gave 50 mg of Benadryl, IM, right deltoid by S. Lisman, RN. Pt took one dose of albuterol inhaler (RX'd to her by PMD). EMS was called and arrived on scene to assess patient. Patient refused transport. Observed patient in observation area of an additional 30 minutes. 1:30-1:45 pm. S. Lisman educated patient on signs and symptoms of worsening condition and when to call 911. Pt advised to accept transport if, signs and symptoms return post Benadryl is no longer in her system.
61 2021-04-06 peripheral swelling Did fine day of shot but next morning woke up felt like I got hit by a Mack Truck my left arm that ... Read more
Did fine day of shot but next morning woke up felt like I got hit by a Mack Truck my left arm that I received shot swelled alot. I not experience that with previous flu shots or my pneumonia shot. I felt weird and sort of sick for 2 weeks.
61 2021-04-06 peripheral swelling In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash ac... Read more
In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As if this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday
61 2021-04-06 swelling face In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash ac... Read more
In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As of this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday. Feel cold.
61 2021-04-07 swelling In order of occurrence: Chills/Face and neck hot and itchy, red rash on face Back itchy, red rash ac... Read more
In order of occurrence: Chills/Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As of this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday. Feel cold. Note that after my shot I was out until about 4:30 pm. While out, I noticed that my face and neck felt hot and my neck was getting itchy, but I did not check it. After returning home, the itchiness, chills. etc. slowly increased until at 6:30 pm I was very
61 2021-04-08 anaphylactic reaction, white blood cell count increased Anaphylaxis leading to intubation and hospitalization
61 2021-04-08 lymph node pain Developed fever up to 102 degrees F as of 9 PM on the day of vaccination, plus muscle and joint ache... Read more
Developed fever up to 102 degrees F as of 9 PM on the day of vaccination, plus muscle and joint aches, chills, and headache. These symptoms continued the next day along with sore arm, and fever went up to 103.6 degrees F. By bedtime on the second day, March 16, fever, aches and pains, and headache were gone. However, I felt very fatigued and I was sweating profusely all night. I had to get up and change soaked clothing three times during the night. Within 3 days, my arm was still very sore and the lymph nodes in the armpit of the vaccinated arm became very sore. I also began having diarrhea several times per day on approximately the third day after vaccination and this has continued to the present.
61 2021-04-08 lymph node swelling Fever >101, muscle aches, joint pain, swollen lymph nodes, INCREASED HEART RATE performing normal ta... Read more
Fever >101, muscle aches, joint pain, swollen lymph nodes, INCREASED HEART RATE performing normal tasks
61 2021-04-08 lymph node swelling About 36 hours after my first dose, I woke up very thirsty and with "gummy," sticky eyes. My moistu... Read more
About 36 hours after my first dose, I woke up very thirsty and with "gummy," sticky eyes. My moisture-producing glands, particularly my salivary glands were significantly affected and I had, in effect, (drug-induced?) Sjogrens Syndrome. My salivary glands felt uncomfortable, perhaps because they were swollen. The symptoms have diminished somewhat in the past two weeks, but have not resolved. I visited my PCP on 04/02/2021 and she advised to see her again if the symptoms did not continue to resolve on their own. Note that in 2014, I had a similar, but more severe reaction to a single dose of Nitrofurantoin and regained nearly complete salivary gland function after 9-12 months.
61 2021-04-08 peripheral swelling Within twenty fours hours, left foot swollen after 1 and 2nd dose.
61 2021-04-09 peripheral swelling back of arm has a bit and has gotten bigger and it was not the injection site where the mark is gett... Read more
back of arm has a bit and has gotten bigger and it was not the injection site where the mark is getting bigger; back of arm has a bit and has gotten bigger and it was not the injection site where the mark is getting bigger; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 09Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that patient had the shot on the 09Mar2021 back of arm has a bit and has gotten bigger and it was not the injection site where the mark is getting bigger. The outcome of the event was unknown. Information on batch number has been requested.
61 2021-04-10 lymph node swelling Tiredness started on 4/8/21 at approximately 2:00 pm. Chills and body aches started on 4/8/21 at ap... Read more
Tiredness started on 4/8/21 at approximately 2:00 pm. Chills and body aches started on 4/8/21 at approximately 5:00 pm. Swelling and soreness of the lymph nodes in the right armpit started during the night of 4/8/21. It is currently 1:55 pm on 4/11/21, at this reporting. The lymph nodes are still swollen and sore. All other side effects were gone as of 4:00 pm on 4/9/21. I have been taking Ibuprofen regularly for the pain and swelling. Swelling has gone down slightly.
61 2021-04-11 lymph node swelling Patient received her second Pfizer covid vaccine on Tuesday 4/6/21. She said she had been doing yard... Read more
Patient received her second Pfizer covid vaccine on Tuesday 4/6/21. She said she had been doing yard work before she came to get her vaccine. After she received her vaccine she felt fine. On Tuesday night she started to feel some itchiness. She said the itchiness got worse over the next two days. She talked to her husband and he advised her to take Benadryl so she took two Benadryl. On Wednesday she had some soreness at her injection site. Very early Thursday morning she noticed a golf ball sized knot in her armpit. She said it was sore and if she rubbed it, it felt like it was pushing into her breast. She said it felt like pressure going all the way to her breast bone and along her esophagus. She ended up calling EMS and her blood pressure was up to 181/107 and had a high heart rate. She said she never had any hives but did have some throat, tongue, and lip swelling and said that her throat felt raw. The EMS gave her 2 nitroglycerin tablets and 5 aspirin. She spent Friday and Saturday in the hospital. She said the hospital did all kinds of cardiac tests on her and everything can back clear besides a leaky heart valve. She said she is feeling much better now and that the hospital was not sure if it was a reaction to the vaccine, something else, or a combination of things that caused it.
61 2021-04-12 lymph node swelling Two days after receiving the vaccine, the front of my neck developed a very itchy, warm rash, my lym... Read more
Two days after receiving the vaccine, the front of my neck developed a very itchy, warm rash, my lymph glands on the right side of my neck swelled so much that it was difficult to swallow even liquids without pain, and I had a fever of about 100. The itchy area on my neck continued to worsen, and despite the application of OTC anti-itch medications and me taking Benedryl, it got larger and warmer, and the itching became even more severe. At one point my throat was so swollen, I started to think it was closing up and that I'd need to go to the hospital. The discomfort continued into the next day when I contacted Teledoc, and was prescribed an antibiotic, and prednisone, which helped. The itching is still present, but managed by regular spraying of an aerosol cortisone. And the swelling has gone, but there are slight scars like one would get from a scrape. My throat is much better, and my fever is gone.
61 2021-04-12 lymph node swelling 4/9/2021: mild headache, arm soreness, muscle aches, tiredness and chills beginning about 6pm. 4/10/... Read more
4/9/2021: mild headache, arm soreness, muscle aches, tiredness and chills beginning about 6pm. 4/10/2021: headache moderate, muscle aches and joint pain moderate; chills, tiredness, diarrhea beginning in the morning and ending early afternoon; 4/11/2021: woke at 5am because left arm (injection site) hurt; arm mildly swollen along with armpit lymph nodes in left arm, tiredness. 4/12 & 4/13: armpit lymph nodes still a little swollen and tender, arm tender, slight tiredness, other symptoms have resolved but lymph node swelling continues
61 2021-04-12 peripheral swelling The morning after the second injection, Woke up nauseated, some vomiting, intermittent chills, no fe... Read more
The morning after the second injection, Woke up nauseated, some vomiting, intermittent chills, no fever. All symptoms were gone within 6 hours. Within a few weeks (timeline not exact) a lump was noticed under the left armpit, which remains
61 2021-04-13 guillain-barre syndrome Diagnosed as Guillan-Barre?Syndrome
61 2021-04-13 lymph node swelling Systemic: Lymph Node Swelling-Medium, Additional Details: Pt has experience some lymph node swelling... Read more
Systemic: Lymph Node Swelling-Medium, Additional Details: Pt has experience some lymph node swelling 3 weeks after the first dose. She experience it in her left axillary.
61 2021-04-13 lymph node swelling Swollen lymph nodes under right arm (same side as vaccine). No other symptoms.
61 2021-04-13 peripheral swelling, swelling Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills... Read more
Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.
61 2021-04-13 peripheral swelling Joints aching and sweats Third day back ache and swelling of hands 04-14-2021. Swelling of hands ... Read more
Joints aching and sweats Third day back ache and swelling of hands 04-14-2021. Swelling of hands back aches still.
61 2021-04-14 lymph node swelling Metallic taste 2 min later. High blood pressure 5 min later. Swollen lymph mode on collarbone 10 da... Read more
Metallic taste 2 min later. High blood pressure 5 min later. Swollen lymph mode on collarbone 10 days later.
61 2021-04-14 peripheral swelling Not sure exactly when this problem began, but definitely after vaccination. Both hands feel very art... Read more
Not sure exactly when this problem began, but definitely after vaccination. Both hands feel very arthritic. Most proximal knuckle of left long finger is visibly enlarged and painful to any pressure. That finger is very uncomfortable almost all the time. Neither heat nor Ibuprofen decrease pain. No specific finger on the right hand is more affected, but that hand is frequently painful and stiff. Again, neither heat nor Ibuprofen have any effect on the pain. I had not noticed these symptoms prior to Covid-19 vaccination.
61 2021-04-14 peripheral swelling Largest flare of Rheumatoid Arthritis I've ever had in 8 years. I could barely move fingers on eith... Read more
Largest flare of Rheumatoid Arthritis I've ever had in 8 years. I could barely move fingers on either hand without a lot of pain and could only make half a fist because of swelling. Reaction appeared to involve both hands and left elbow only. It was very sudden and required a visit to the Rheumatologist for relief.
61 2021-04-14 swelling Broke out in itchy, swollen, red rash. Began as single spot on right eyelid withing 4 hours of recei... Read more
Broke out in itchy, swollen, red rash. Began as single spot on right eyelid withing 4 hours of receiving vaccine. Spread over first week, across temple and forehead and chin, later on belly (which spread to cover 1/4 torso below waist on front side), between legs on both sides at top of inner thighs, latter on outer thighs of both legs. Felt like needles pricking skin if fabric touched skin. Lasted three weeks. However, at three weeks I am sill not over the rash. I can now function normally, even though the skin is still red and slightly itchy. Oddly, the rash was strong on the right side of my body with a fainter mirror image on the left side. I reported all this on the V-SAFE app.
61 2021-04-15 swollen extremities Day after 2nd dose patient developed erythematous rash with underlying edema on legs and back. 7 day... Read more
Day after 2nd dose patient developed erythematous rash with underlying edema on legs and back. 7 days later patient developed similar rashes on forearms and arms. Rash is made up of papules with surround erythema/edema (~5cm max diameter) and is pruritic and burning. Associated myalgias and fatigue
61 2021-04-16 lymph node pain I had some site soreness for several days...nothing too bad. Took some Tylenol for it. Two days afte... Read more
I had some site soreness for several days...nothing too bad. Took some Tylenol for it. Two days after injection I got pretty bad diarrhea that lasted several days. I also got the chills/shakes the second night. Then I got a pretty bad Eczema flare...on my breasts. It continues at week two. My left armpit HURT terribly for almost a week. Tylenol did not relieve it at all. I also had quite sore Lymph nodes across my chest/side of neck.
61 2021-04-16 peripheral swelling Swollen portions of hands, portions of feet, knees. Inflamed, red, hot, itchy and very, very painful... Read more
Swollen portions of hands, portions of feet, knees. Inflamed, red, hot, itchy and very, very painful. The issues move from area to area and seem to inflame fatty areas most. I thought this would go away and didn't document with pictures, like I should have. I now have a couple of pictures and will continue to do so. I've tried hot baths, cold packs, hot packs, elevating the area and topical relievers. I couldn't feel the heat of the pain reliever on the affected area. This has been absolutely debilitating and I've had to miss some work because of it.
61 2021-04-17 swelling I had a full blown red rash all over my body; red lesions all over my leg and my back and red marks ... Read more
I had a full blown red rash all over my body; red lesions all over my leg and my back and red marks and scratches all over my chest, my back, legs; it downed the swelling and the itch but I still have red rashes and scratch and red marks all over my body; had a severe reaction; The next day after vaccine I had extreme hives, red welps all over by body from head to toe; This is a spontaneous report received from a contactable consumer. A 61-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2; Formulation: Solution for injection), via unspecified route of administration on Left arm on 24Mar2021 12.00 at single dose for covid-19 immunization and second dose of bnt162b2 (BNT162B2; Formulation: Solution for injection), via unspecified route of administration on Left arm on 24Mar2021 12.00 at single dose for covid-19 immunization. Relevant medical history includes Von Willebrand Type 2 bleeding disorder. Concomitant medications include Lisinopril. It was reported that the next day after vaccine I had extreme hives, red welps all over by body from head to toe on 25Mar2021 at 13.00 PM and treated with Prednisone/Atarax and resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient not diagnosed with COVID-19. Patient weather tested positive for COVID-19 since having the vaccine is unknown. Upon follow up on 31Mar2021, there wasn't side effects with the first shot, it was with the 2nd shot, developing rash on the second day, red rash, welts, swollen, severe scratch marks on chest, swelling on shoulders and welts, arms with welts and scratch marks, and major scratch marks and welts on lakes, and big old red patch on my left calf. The next day went to Clinic and saw a doctor, he couldn't even believe it, he was gasping at what he saw, gave me prednisone for severe allergic reaction, today is the last day of treatment, I started prednisone on Friday and the last day is today. It did take down swelling itching and pain, now I am left with patches, welts, scratches on my chest and red lesions and big red patch on my left calf. Can send pics if you want. I want to know how to get rid of the patches, or when will they go away? can you suggest what I can take? I am going to go to a haematologist next week, because I do have a bleeding disorder. It looks to me like these are going to be the scars and they are not going to go away. It feels like someone took their nails and just scratched., looks like they aren't going to go away. " Response: Spoke from attached document: explained that Pfizer is unable to provide treatment and management recommendations and referred to HCP. Offered to email document for review with HCP, and for links for latest information and reporting. Upon follow up on 31Mar2021, I had my 2nd vaccine of the Pfizer Vaccine on 24Mar2021 and the next day I started seeing a rash, mild rash and then on the 25mar2021 I had a full blown red rash all over my body and red lesions all over my leg and my back and red marks and scratches all over my chest, my back, legs and so I went to my doctor on the 26mar2021 they prescribed Prednisone and so I am on my last of the Prednisone, it downed the swelling and the itch but I still have red rashes and scratch and red marks all over my body, I had a severe reaction." Consumer stated, " I took pictures, so I can send them, so they can see what it did I don't know. Well I wanted to see like what Pfizer can do to help me, this is like not going away any time soon, I going to see another one of my doctor next week." Consumer was informed about the role of Pfizer Drug Safety and permission to probe: consumer stated, " Well actually I'm expecting a call from my doctor, I need to take his call." The outcome of the events for "Urticaria" was "Not recovered", for "Rash", "Skin lesion", "Swelling", and for "Reaction aggravation" was "Unknown". No follow-up attempts are possible; information about lot/batch number cannot be obtained. Follow-up (31Mar2021): New information received from a contactable consumer: New clinical information (Product details, and new adverse event information) added. Follow-up (31Mar2021): New information received from a contactable consumer: New clinical information added. No follow-up attempts are needed. No further information is expected.
61 2021-04-18 anaphylactic reaction anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely r... Read more
anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely red all over body; Abnormal liver enzymes; Hr became Brady with widening if qtinterval; leg cramps; neuro s/s migraine severe; throat closed; Weight gain 15+ lbs on body non pitting edema; non pitting edema; extreme leg pain; breathing problems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 via an unspecified route of administration in right arm on 27Mar2021 16:45 (Lot Number: er8733, expiration date was unknown) as single dose for covid-19 immunisation. Medical history included asthma, brain disorder, arthritis, vertigo. Patient had known allergies. It was unknown if patient had COVID prior vaccination. She was not pregnant at the time of vaccination. Patient did not have other vaccine in four weeks. She used other medications in two weeks. The patient experienced anaphylaxis within 5 minutes went home extreme leg pain. Her throat closed and she had short of breath (SOB). She had extremely red all over body. She went back to emergency department (ED). Electrocardiogram (EKG), X-ray and blood work were done. She had c/o leg cramps. Her weight gain more than 15 lbs on body with non-pitting edema. She received treatment for events. She had abnormal liver enzymes, abnormal heart problems and breathing problems. Anaphylactic condition was to step down was on bipap epi (Epinephrine injection) Benadryl 50 mg every 4 hours and intravenous steroids along with fluids. Renal replacement therapy (RRT) called the next day. Patient didn't remember exact cause. Neuro s/s migraine severe Ajovy taken Uberlvy and not else remembered (as reported). Heart issues maintained and pulmonary showed improvement. Ear, nose, and throat (ENT) consult with scope done showing vocal cord dyskinesia. Heart rate became brady with widening if qt interval. She transferred to telemetry 2 d and echo done. Monitor patient for low heart rate 24 hours. Patient released from hospital on 06Apr2021 evening. At home patient continue to have organs change every 24- 36 hours keeping video monitoring and pictures. All events occurred on 27Mar2021 16:45 and resulted 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). The duration of hospitalization was 6 days. Patient tested COVID-19 via nasal swab on 01Apr2021 with negative result. Benadryl 50 mg she had around the clock, steroids and epi used as treatment. The outcome of all events was not recovered. No follow up attempts are possible. No further information is expected.
61 2021-04-19 anaphylactic reaction Six days after my 2nd vaccine I had an anaphylaxis reaction. Out of the blue while I was driving my... Read more
Six days after my 2nd vaccine I had an anaphylaxis reaction. Out of the blue while I was driving my face started to burn like acid was rubbed on it. It got really hot and turned very bright red. Then my lips began to feel like they had been sunburned badly. Then my forearms both started burning and also turned bright red. I was very anxious. Had two bouts of diarrhea. All this occurred within about a 20 minute time-frame. I chewed up 4 children's Benadryl (50mg) and the redness, burning and anxiousness subsided mostly. My heart rat was still over 100 bpm even after 6 hours. (Usually my HR is 68-70 bpm). I slept for 12 hours and the next day seemed fine. This has occurred two more times since that first time. The 2nd reaction being 5 days after that first one and the 3rd reaction being 5 days after that. Same reaction, same treatment and same outcome.
61 2021-04-22 guillain-barre syndrome 02/24/2021 Guillain Barre' Syndrome 04/19/2021 Renal Failure with other complications
61 2021-04-24 anaphylactic reaction Anaphylaxis-swelling of eyes, tongue, and injection site, rash/hives, shortness of breath, and dizzi... Read more
Anaphylaxis-swelling of eyes, tongue, and injection site, rash/hives, shortness of breath, and dizziness; Anaphylaxis-swelling of eyes, tongue, and injection site.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration, administered in right arm on 05Apr2021 16:00 as single dose for COVID-19 immunization. Medical history included known allergies: yes and hypertension. The patient was not pregnant. Concomitant medications included metoprolol succinate (TOPROL XL), lisinopril dihydrate (LISINOPRIL), and cetirizine hydrochloride (ZYRTEC). The patient had no other vaccine in 4 weeks. On 05Apr2021 16:15, the patient experienced anaphylaxis-swelling of eyes, tongue, and injection site, rash/hives, shortness of breath, and dizziness. The events resulted in emergency room/ department or urgent care. Therapy for the events included prednisone, antihistamine, and intravenous (IV) fluid. The patient did not have covid prior vaccination and was not Covid tested post vaccination. Outcome of events was recovering. Information about lot/batch number has been requested.
61 2021-04-24 lymph node swelling, lymph node pain Having injection site pain; Nausea; Can hardly hold her head up; She slept all day yesterday, and sl... Read more
Having injection site pain; Nausea; Can hardly hold her head up; She slept all day yesterday, and slept all night; She just gets hot; Feeling unwell; blood pressure was out of control; lymph nodes are not as bad, they are hurting; She is having hot flashes; Tiredness/ she is still tired; Muscle and joint pain; swollen lymph nodes under arm; muscle and joint pain; Chills; Headaches; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old-female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: CR8732 or LR8732) first dose on 03Apr2021 08:30 on right arm at single dose for COVID-19 immunization. Medical history included ongoing High blood pressure (Has had a long time), Breast cancer (Has had 6 years) and covid in Feb2021. History of all previously immunizations was No. Prior vaccincations wtihin 4 weeks was No. AE's following prior vaccinations was No. Concomitant medications included anastrozole (ARIMIDEX, strength 20 mg) for breast cancer (Has not taken the last 3 days, Did not want to take with the shot), bisoprolol fumarate, hydrochlorothiazide (BISOPROLOL HCT) for Blood pressure (States that she was taking 5-6.25mg and increased dose to taking 10 in the morning and 5 at night) and ongoing Vitamins. States that in Feb2021 had Covid and had gotten over that and was discharged. States that she might have had mild Covid and with all of the variances coming out, she wanted to get the vaccine. States that she got her first dose on Saturday (03Apr2021) and didn't know if she hadn't waited long enough. Caller states that she has been having terrible reactions. Has been having injection site pain but even had that with the flu shot. States that she has been experiencing tiredness, headaches, muscle pain, chills, joint pain, and lymph nodes under her arm were swollen where she got the shot. Has also been experiencing nausea and can hardly hold her head up. States that she slept all day yesterday, and slept all night. Woke up this morning feeling a little bit better, then the side effects took a hold of her again. Caller states that cancer meds made her gain weight and hasn't been able to get rid of it. Noticed Tiredness yesterday (04Apr2021) when she woke up. States that she had the vaccine on Saturday the 03Apr2021 at 8:30am, started to have headache that night. States when she woke up yesterday (04Apr2021), she started experiencing all of the other symptoms, tiredness, headaches, muscle pain, chills, joint pain, and lymph nodes under her arm were swollen where she got the shot. States that when she woke this morning, had thought everything was a little better but, then it hit her again. Clarifies she is still tired, and the headache still has not gone away. This morning (05Apr2021) she is having hot flashes, not so much the chills. The chills are still there but not nearly as bad, she just gets hot. She has been experiencing nausea and feeling unwell. States that the lymph nodes are not as bad, they are hurting but, not as bad. States that it is hopefully doing what it is supposed to do. States that she has been taking only Tylenol but has not taking it yet today. States that she is super scared to get the second shot. If this happened with the first shot, is terrified for the second shot. States that she has been taking Tylenol every four hours and is such a lightweight that she has only been taking one Tylenol every four hours. Caller states that she is supposed to be back 24Apr2021 for second shot but does not know if she can go through with it. States that this was recently increased when her blood pressure was out of control when she had gotten Covid. States that she was taking 5-6.25mg and her dose was increased dose to taking 10 in the morning and 5 at night. States that she is not taking as prescribed but she was too chicken to take the 10mg. States she will be back to see her doctor on 16Apr2021. States that she hates taking any medicine. Tests: States that she had bloodwork done Friday (02Apr2021) but has no idea of the results. States she will be seeing her doctor 16Apr2021 to go over the results. Vaccination facility type was Hospital drive up. Vaccine administered at military facility was No. No events required to ER. Caller states she has contacted her doctor to find out about her future vaccination. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
61 2021-04-24 lymph node swelling, swelling face face and throat swelling and redness; face and throat swelling and redness; mild face swelling; lymp... Read more
face and throat swelling and redness; face and throat swelling and redness; mild face swelling; lymph nodes swelling in armpits; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; Lot Number: ER8737 and expiration date was not reported), via an unspecified route administered in right arm on 31Mar2021 at 12:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. The patient had no known allergies to medications, food or other products. The patient's medical history included ductal carcinoma in situ (DCIS). The patient previously 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, date and dose for COVID-19 immunization. The patient was not pregnant. It was reported that no other vaccine was given in four weeks but patient had received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced mild face swelling and lymph nodes swelling in armpits on day 1 (01Apr2021) after vaccination. On day 2 and 3 after vaccination, the patient had only mild face swelling. On day 4 (04Apr2021), the patient experienced severe face and throat swelling and redness. The patient rushed to the emergency room (ER) but conditions reduced by 80% by the time of arrival at the ER. The patient took diphenhydramine (BENADRYL) tablets and the doctor prescribed an epinephrine autoinjector (EPIPEN) and told her to keep on hand. From day 5 to day 8, mild facial swelling still exits. On day 9 (09Apr2021), patient had just a trace of facial swelling. It seems like conditions were getting normal. The outcome of the event facial swelling was recovering at the reporting time. The outcome of lymph nodes swelling in armpits and severe face and throat swelling and redness was recovered at the reporting time on Apr2021. No follow-up attempts are possible. No further information is expected.
61 2021-04-24 swelling Noticed swelling in my neck on 5th day after 2nd dose of vaccine, Tuesday April 20th. Was seen in ... Read more
Noticed swelling in my neck on 5th day after 2nd dose of vaccine, Tuesday April 20th. Was seen in urgent care on Wednesday evening April 22, diagnosed with parotitis and prescribed Augmentin. Continued to worsen, was treated on Friday April 23. I received IV antibiotics while in ER. Am continuing to take clindamycin and metronidazole. Condition is improving.
61 2021-04-25 oral herpes Upper & lower lip swelling , blisters/cold sore on each side of mouth, few bumps on roof of mouth, s... Read more
Upper & lower lip swelling , blisters/cold sore on each side of mouth, few bumps on roof of mouth, severely chapped lips. Lip swelling lasted 5 days, bumps on roof of mouth lasted 1 day, chapped lips lasted 2.5 weeks but are still very dry and blisters/cold sores are not as visible but skin at corners of mouth are red and tender and opening mouth to eat causes discomfort
61 2021-04-25 peripheral swelling After 2nd shot within 24 hours my arm swelled up and became itchy , achy and red . As the night prog... Read more
After 2nd shot within 24 hours my arm swelled up and became itchy , achy and red . As the night progressed it became worse and now 3 days later my arm is swollen, itchy, achy, and red from my elbow up to my shoulder at the place of injection. Went and seen my Dr. today.
61 2021-04-27 anaphylactic reaction, swelling I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pai... Read more
I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.
61 2021-04-27 lymph node swelling Tiredness; Chills; Fever; Doesn't feel good, weak; Lymph node swollen, hurts, can't touch it; Nauseo... Read more
Tiredness; Chills; Fever; Doesn't feel good, weak; Lymph node swollen, hurts, can't touch it; Nauseous; Headache; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old female patient received the second dose of BNT162B2 (COMIRNATY Formulation: Solution for injection) via unspecified route of administration as a SINGLE DOSE on 07Apr2021 02:35PM for COVID-19 immunization. The patient had no relevant medical history and family history. Patient received historical vaccine of first dose BNT162B2 (COMIRNATY) via unspecified route of administration in left arm on 17Mar2021 02:35 PM for COVID-19 immunization. Medical history and concomitant medication was not reported. No family history. Patient reported as does not think her medications had anything to do with the events. she takes all the same medications and didn't have any events with the first vaccine. On 07Apr2021 at 14:35 after second vaccine she got headache right after that and still ongoing. On 08Apr2021 lymph node under arm swollen hurts and she can't touch it and still ongoing, she was nauseous around 5 or 6 in evening. On 08Apr2021 2:00 AM she had chills, tiredness, doesn't feel good weak and fever was 100.5 then it went higher and lower. Second shot on Wednesday and she really sick was 25 percent better today. No Prior Vaccinations (within 4 weeks). The outcome of event recovered for Chills, Fever on 09Apr2021, Nauseous on 08Apr0221 and not recovered for Tiredness, Headache, Doesn't feel good, weak, Lymph node swollen, hurts, can't touch it. No follow-up attempts are needed. No further information is expected.
61 2021-04-28 anaphylactic reaction Anaphylaxis- patient unconscious briefly prior to receiving Epinephrine. After injection, patient sl... Read more
Anaphylaxis- patient unconscious briefly prior to receiving Epinephrine. After injection, patient slightly arousable- transferred to ED via EMS.
61 2021-04-30 lymph node swelling Day of shot, extreme fatigue along with slight additional aches, headache as usual. Lemon-sized lymp... Read more
Day of shot, extreme fatigue along with slight additional aches, headache as usual. Lemon-sized lymph node outside armpit of shot. On 5/1 noticed a bruise on side of breast and chills. No fever. Hopefully all will be gone soon otherwise will see physician.
61 2021-04-30 peripheral swelling Chills; She was feeling achy and fluish; She was feeling achy and fluish; Swelling of left foot/Swel... Read more
Chills; She was feeling achy and fluish; She was feeling achy and fluish; Swelling of left foot/Swelling of right foot; Headache; Fatigue/felt tired; dizziness/Little dizzy; not feeling too good /Feeling hot/like a low grade fever/fever; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on 02Apr2021 (at the age of 61-year-old), at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 02Apr2021, patient had headache, fatigue/felt tired, dizziness/little dizzy, and not feeling too good /Feeling hot/like a low grade fever/fever. She reported that to her doctor. On 03Apr2021, patient had swelling of left foot. On 11Apr2021, patient had swelling of right foot. On unknown date, patient experienced chills, lasted for a quarter of a day, "Friday". On unknown date, patient was feeling achy and fluish. Patient stated when she took her first dose she woke up and had slight swelling of her left foot (03Apr2021). She reported her foot would go and would elevate it. She then experienced it again on 08Apr2021, 09Apr2021, and 12Apr2021. She also had swelling of her right foot on 11Apr2021. She was wondering if she should get the second dose of the vaccine, scheduled on 23Apr2021. The swelling was mostly in her left foot and it started day after vaccine. With elevation her left foot was better. It went down for a few days and she didn't have any swelling, then it started back again on 11Apr2021 and 12Apr2021, and it was "Saturday" or something then she had it again. She kept it elevated and it would go down some and come back. Her right foot had gone down but her left was still up. Patient was a little dizzy on 02Apr2021 right after the injection. Saturday she was dizzy and then the fatigue set in and that was Saturday and Sunday. The fatigue started leaving. It was worse and then started feeling better. Patient had headache on 02Apr2021. The headache started that afternoon with a full effect the evening of 02Apr2021, 03Apr2021 and the first part of Thursday she felt it then as well. She wasn't so bad Monday as far as the fatigue. She didn't have the fever on Sunday. As far as the fatigue clarified it started that evening of the vaccine. The only thing that stayed was the headache and fatigue. Everything else felt pretty good right after and she was mostly her normal self that Wednesday. Other than that as far as Wednesday she was a little bit fatigued. She tried going to work and worked through it. She was able to sit down here and there when she felt bad. She went to work Saturday and Sunday. It was a lot better. She told her daughter she was not feeling too good and went and laid down and she started feeling hot. It was like, not how a bad fever felt, but like a low grade fever. That evening she had the hotness, maybe later like 1800 or 1900, up until Saturday. It wasn't all day Saturday. It was not like a bad fever, just hot. It went away. She was feeling achy and flu-ish. She laid down and went to sleep and tried to get up the next morning. She took something like paracetamol( TYLENOL) and called the doctor Friday. They told her to use fever reducers because of the fever. When she went in to see the doctor on Tuesday she could do a little with the fatigue and after that would do a little bit and start to felt tired. She would go back and lay back down. She took 3 days off. Other than that it was like having the flu or something. She has had flu shots and had a reaction to it and it would go as time went on. She asked what's going on with this. She had the flu shot 3 different times and only one time had a reaction. She never had swelling or anything, that's what she was concerned about. The reaction to the flu shot was years ago, and she didn't have a foot reaction. The outcome of the event "swelling of feet", "fatigue" was recovering; of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
61 2021-04-30 swelling face She will be deceased, most likely, if she does.; arms really heavy, can hardly lift them; arms reall... Read more
She will be deceased, most likely, if she does.; arms really heavy, can hardly lift them; arms really heavy, can hardly lift them; She feels sick and unwell; face little swollen; chest pain; pressure in chest; ears ringing; Difficulty breathing; Migraine headache; heart palpitations; Chills; nausea; really red face, cheeks; back pain a lot worse; very high fever; This is a spontaneous report from a contactable consumer (patient) A 61-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 08Apr2021 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation . Age at vaccination :61 years. Medical history included ongoing epilepsy (started at 16 years old. Has not had a seizure in years, maybe 20 years) ,herniated disc and chronic back pain from 2003 and ongoing , Heart septal defect (repaired) and seizure disorder.Concomitant medication(s) included carbamazepine (CARBAMAZEPINE)at 200 mg, 1x/day taken for seizure from an unspecified start date and ongoing. The patient experienced "she will be dead, most likely, if she does" on an unspecified date , difficulty breathing on 10Apr2021 with outcome of unknown , very high fever (on 08Apr2021 with outcome of recovering , migraine headache on 10Apr2021 with outcome of recovering , heart palpitations on 10Apr2021 with outcome of not recovered , back pain a lot worse on 08Apr2021 with outcome of not recovered , ears ringing on 10Apr2021 with outcome of recovering , chills on 09Apr2021 with outcome of recovering , nausea on 09Apr2021 with outcome of not recovered , pressure in chest on 10Apr2021 with outcome of not recovered , chest pain on 14Apr2021 with outcome of not recovered , arms really heavy, can hardly lift them (non-serious) on 15Apr2021 with outcome of recovering , really red face, cheeks on 09Apr2021 with outcome of not recovered, face swelling on 14Apr2021 with outcome of not recovered and She feels sick and unwell on 14Apr2021 with outcome of not recovered. Clincal course was reported as follows:On 08Apr2021 she had her vaccine. She is running a fever and has every side effect on the template from the pharmacy. She is not doing good and should probably be in the hospital. She can not drive her self, or have anyone else drive her. She feels really bad and is afraid of a clot. This is from the first shot and she is not getting another. She will be dead, most likely, if she does.She can hardly lift her arms up. She did not see this in list of side effects and doesn't know what that is.She tried to make a claim with Covid compensation number, but was unable to connect with them. Her symptoms started 3 days ago. She did this in case she had to. She read she has to keep her fever down. She just took some Tylenol.She didn't look for few days at the paperwork provided to her after the vaccine. She was seeing side effects and she got nervous, this is why she didn't call earlier.She is having trouble breathing now and has never been so sick. Caller asking how long the side effects last and needs to talk with Medical Information.Her Mother recommended she receive the vaccine and told her of all these people coming across the boarder and that they may bring Covid with them.She had a septal defect repaired in her heart. She doesn't know if there could be something wrong with that, but her doctor and heart doctor said she is fine. They haven't found anything from the testing she had had.Her difficulty breathing is on and off. It started 2-3 days after, and she doesn't know with her heart palpitations and if there could be damage. That's why she called the Covid compensation.The first day, she had a very high fever and headache. She didn't take her temperature, but she knew it was a fever. Today it is not as high as it was, it's not bad.She had a migraine and took something for it and it went away for hours. She took aspirin, Bayer Back and Body, and her fever and headache went away for hours.She experiences heart palpitations. Every time she eats they get worse. She has reported this to her physician. Her Physician said to take Tylenol and gets exercise. She recommended she doesn't lay up and caller thinks she wanted her to go to the hospital. Caller's mother can't drive and her sister is dying of cancer. Caller lives near her mother but she can't drive. She's older and caller can't ask her to do that.Her palpitations are sometimes there.She has a back injury from someone hitting her from behind. It is extreme back pain. It worsens after she gets a vaccine. She gets on the heat pad. She doesn't have anything for it, just some patches.Her ears are not ringing now and might be getting better. She had chills, but they're better today.She had nausea. It's better today. Yesterday, when talking to her doctor caller was advised to exercise. That makes her feel worse. It's not a big thing. She feels sick and unwell.Her face is really red and maybe a little swollen. Her Physician was thorough and she even asked about it, and commented it sure is red.Caller lays in bed and keeps her feet up. She knows she's got to move around, her Physician told her to.Caller is concerned about a blood clot. She is having pressure and pain in her chest. It has been the same. What's new is chest pain yesterday and did not feel bad, but it is noticeable. She hopes it doesn't get worse. What is new is her arms feel really heavy and she can't hardly lift them.Her facial redness worsened with her fever. The Tylenol is working, her fever is going down, but her arms are still heavy, but better.Treatment received for arms really heavy, can hardly lift them and very high fever.Additional information:Vaccination Facility Type: Pharmacy/Drug Store . No COVID Prior Vaccinations
61 2021-05-01 lymph node swelling Covid tongue (oral thrush) plus ulcers along with sore throat and swollen lymph nodes in neck. Start... Read more
Covid tongue (oral thrush) plus ulcers along with sore throat and swollen lymph nodes in neck. Started two to three days after second vaccination. Typical symptoms fatigue, headache occurred between 24-48 hours of getting the second shot.
61 2021-05-02 lymph node swelling Patient came to the pharmacy today and states she received her 2nd dose on 04/28 and after 72h start... Read more
Patient came to the pharmacy today and states she received her 2nd dose on 04/28 and after 72h started to feel a lump on left side of neck and and swelling. I explained lymphadenopathy was a rare side effect of vaccine occurring in less than 0.3% o f the population.
61 2021-05-03 swelling face Allergic Reaction at testing site transported to ED via EMS from home. Throat and facial swelling , ... Read more
Allergic Reaction at testing site transported to ED via EMS from home. Throat and facial swelling , tight breathing Treated with Benadryl and Epinephrine
61 2021-05-05 peripheral swelling Pt woke up at 1 am on 5/1/21 and noticed a small red bump on the inside of her arm, between her elbo... Read more
Pt woke up at 1 am on 5/1/21 and noticed a small red bump on the inside of her arm, between her elbow and wrist. Tuesday morning 5/4/21 patient noticed several blotchy red spots around injection site and now her whole right arm is swollen. She reports a bump at the injection site. It is very painful and warm to touch. Gabapentin 100mg tid started on 5/3/21, Cipro 500mg BID x 10 days started on 5/4/21 and Prednisone 20mg QD x 7 days started today, 5/6/21. Pt also reports having lifted a 70#box of tile that resulted in her "pulling a muscle" in her shoulder/neck area on her right side. She has been icing the site.
61 2021-05-06 peripheral swelling Swelling, redness, rash, heat and pain in lower arm below elbow half way to wrist. Awoke with pain S... Read more
Swelling, redness, rash, heat and pain in lower arm below elbow half way to wrist. Awoke with pain Sunday May 2nd and a red spot on forearm about the size of a 50 cent piece. Monday 5/3 started to spread down the side of my arm, I started icing it and it continued to enlarge. Thur May 6, 2021 was the worst day swelling had dropped down in my arm and made elbow swollen and very tender also. Today May 7 my arm is slightly better but still red rash, swollen and hurts.
61 2021-05-09 lymph node swelling excessive fatigue went on for two weeks. would lay down for a 20 min nap and wake up 4 hrs later. Sw... Read more
excessive fatigue went on for two weeks. would lay down for a 20 min nap and wake up 4 hrs later. Swollen glands under my arms. Hot flashes(which I've never had not even when in menopause) Flare up of my arthritis. Headaches. General feeling of malaise.
61 2021-05-11 swelling Arm injection site soreness did not resolve and spread into arm resulting in continued pain for a mo... Read more
Arm injection site soreness did not resolve and spread into arm resulting in continued pain for a month after. On May 3 I went to see the orthopedic doctor to discuss the continuing pain from injection. Doctor noted swelling, loss of mobility and administered a cortisone shot to help heal the inflammation. I have started physical therapy on doctors recommendation to regain the lost mobility.
61 2021-05-13 lymph node swelling 1st and 2nd dose- swollen glands; injection site pain in right arm; 2nd dose- shingles/shingles blis... Read more
1st and 2nd dose- swollen glands; injection site pain in right arm; 2nd dose- shingles/shingles blisters; felt quite ill/not feeling well; second dose- extreme pain in left hand/sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 08Mar2021 (Batch/Lot Number: EN6208) (at the age of 61-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included breast cancer (2-time breast cancer survivor), had lymph nodes removed, and has low thyroid. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for low thyroid from an unspecified start date and ongoing; ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+) taken for an unspecified indication from an unspecified start date and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication from an unspecified start date and ongoing; famotidine (PEPCIDAC) taken for an unspecified indication from an unspecified start date and ongoing; esomeprazole sodium (NEXIUM) taken for an unspecified indication from an unspecified start date and ongoing. Patient previously took shingles vaccine on an unknown date (reported as number of years ago) for immunization, flu shots on an unknown date for immunization and also previously took the 1st dose of BNT162B2 (Batch/lot number: EN6200) (at the age of 61-years-old) on 15Feb2021, intramuscular administered in the right arm for COVID-19 immunisation, and experienced injection site pain in right arm, sore arm and swollen gland. Patient stated having what was considered typical, like a sore arm and did have some swollen glands with the first and second dose. It was also reported that after 1st and 2nd dose, there was injection site pain in right arm. After second dose she developed shingles, or what was later found out to be shingles, she had extreme pain in her hand. She thought it was injured or something, it was very painful. She got shingles blisters on her hand, and then also got some on her arm, the opposite arm as the injection. Her dermatologist and internist verified it was shingles. Her internist said it may have been triggered by the vaccine. She clarified it started in the palm of her hand and then traveled up her arm on the opposite side of the vaccine, she got the vaccine in the right arm and the shingles in the left arm. She felt quite ill as a result of the shingles. Her dermatologist put on Valtrex, three times a day. It helped with the spread; it stopped spreading. Her dermatologist was not associating it with the vaccine, and she was not sure she was either. After not feeling well for several days she told internist and he was confident that the vaccine was what caused the shingles. She doesn't remember for sure the event extreme pain in left hand, but it was within a few days after the 2nd dose. The swollen glands started within 24 hours, as well as, the sore arm. It wasn't anything she didn't expect. Like with the flu shot maybe a little worse, but it wasn't severe. Her sore arm was not ongoing. It recovered completely by the next day. Swollen glands came back when the shingles first happened, but they initially began within 24 to 48 hours, for both doses. After the second dose she took two extra strength Tylenol again on the first night again; she just took it once after the 2nd dose. Pain in the hand was 98 to 95 percent better. Her doctor did whole blood work up (unknown results) just to see her white count (unknown results) to rule out something else. The blisters were too small for the dermatologist to scrape and get a biopsy. She did not get the most current 2 dose vaccine for shingles, she only got one dose and that was a number of years ago, she was going to get it but then COVID happened. The outcome of event herpes zoster and pain in extremity was resolving while for other events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
61 2021-05-13 peripheral swelling By 12:50 hands were starting to swell; chest pain; heart palpitations; pulse felt like her heart was... Read more
By 12:50 hands were starting to swell; chest pain; heart palpitations; pulse felt like her heart was racing very hard; non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia; non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia; blood pressure was up; throat felt like it was starting to tighten; eyes itchy; eyes itching much worse; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (COMIRANTY; Solution for injection; Lot number and expiration date: unknown), via an unspecified route of administration in left upper arm on 22Apr2021 12:10 (at the age of 61-year-old) as unknown single for COVID-19 immunization. This report was not related to a study or programme. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse events following prior vaccinations was first time had flu shot made her very ill, next year doctor suggested she should just have half of a shot instead of full shot to see if she tolerated it and she was able to tolerate that. She had not any other problems with flu vaccines in general. Some of the other vaccines, she was just supposed to take Benadryl with them because of some of the filler ingredients people put in things. She had previously had the 1 dose shingles vaccine, but she had gotten probably shingles probably a couple of months after that so they encouraged her to get the 2 part shingles vaccine at a later date and told her to do the pre-medicate routine like Benadryl day before, day of and at least 2 days after shingles vaccine doses and if any major problems call for help. She did not have a noticeable problem from the 2 part shingles vaccine. Some of the times depends on what filler ingredients people use. She was allergic to nutmeg which was used as an emollient oil or it's called Myristicin something or other oil; if something has too high a dose of mannitol it can cause a problem. She has a very long list of allergies and high sensitivities; if it was a high enough sensitivity it goes in allergies list, even though it may not be a true allergy. Family has lots of allergies. Regarding prescribed indication additional details: She had 3 doctors who initially advised her to get the vaccine including her primary care physician, oncologist and haematologist; this was because she was a high risk person because of various health issues. Her haematologist 2-3 months ago when she had her last appointment with him he was saying to get the shot and prescribed the epi-pen at that time; no one was having it yet, but he expected she would have some sort of reaction to it not able to be covered by Benadryl alone. Medical history included ongoing platelet disorder Verbatim: Unidentified platelet disorder, Lots of allergies, cardiac murmur, ongoing asthma, osteoarthritis, glucose tolerance impaired, hypoglycaemia slow thyroid and back and neck pain. Concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) taken for hypersensitivity (50mg taken as needed), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for hypersensitivity (10mg daily), fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma (250/50 twice daily), levothyroxine sodium (SYNTHROID) taken for hypothyroidism (137mcg-1 tablet daily), methylphenidate hydrochloride (RITALIN) (20mg tablet twice daily), salsalate, colestyramine (QUESTRAN LIGHT) (2-500mg tablets 3 times daily), sucralfate (CARAFATE) (1mg tablet 4 times daily-dosage verified with caller as milligrams and captured as provided), loperamide hydrochloride (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) (2.5/0.25 takes 2 tablets of that 4 times daily), calcium carbonate (CALCIUM OYSTER SHELL [CALCIUM CARBONATE]) (Alternates dose of 500mg and 1000mg on days takes Vitamin D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) (250 mg), vitamin D (50,000 units every other day taken), vitamin B12 (1mg injection every 14 days), clonazepam (KLONOPIN) (2-1mg tablets at bedtime), montelukast sodium (SINGULAIR) taken for asthma (10mg tablets at bedtime) and cefixime (FLEXERIL [CEFIXIME]) taken for back pain, neck pain (10mg tablets 3 times daily as needed). On 22Apr2021, Onset time: She had a note saying her eyes itchy at 12:20, but they were itching before that because she waited long enough to report it; so onset time was less than 10 minutes when her eyes started itching. Then her pulse; she could feel chest pain; heart palpitations; pulse felt like her heart was racing very hard. They did check her pulse while she was in their initial observation and her pulse was only in the 70s, but oxygenation was at 96%.When at doctors office less than 1 hour before that reading, oxygenation was at 98%.Recorded at 12:30 eyes itching much worse, throat felt like it was starting to tighten, heart felt like it was starting to race. By 12:50 hands were starting to swell. She had already been pre-medicated with Benadryl before this before she went down to get the Pfizer Covid-19 Vaccine, she had Benadryl in her system. She had that same morning with her morning meds had taken Zyrtec and Benadryl in anticipation of getting the possibility of getting the Pfizer Covid-19 Vaccine because she has to pre-medicate for vaccines just in case she starts to react in anyway. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines was not administered on same date of the Pfizer Suspect. Emergency Room taken from the location where vaccine administered-they gave her Pfizer Covid-19 Vaccine shot had her sit for basic observation then sit for extended observation. In that time period telling them her symptoms were going on, increasing. They gave her another 50mg Benadryl even though she had already had 1 before and then called emergency room, took her down, left her in waiting area even though she had heart and chest palpitations. Physician Office seen prior to event on 20Apr2021, seen after event 27Apr2021. Primary Care Physician didn't hear anything in lungs either visit. Not admitted to hospital; seen in emergency room, theoretically she got treated; however her basic blood pressure and stuff even with what they were doing was higher than when she was triaged in the ER; blood pressure was up and something else,oxygenation level moderately reduced from when she came down to when she was just let go; however her symptoms were worse when she was leaving than when she got there. She knows what they gave her while she was there was IV of normal saline, solumedrol and IV Benadryl. Thinks they later gave her Tylenol tablets. Finally got them to do an EKG because kept saying her chest was getting worse but that was several hours after she was back there even though came there having chest pains. In her opinion this hospital was not taking reaction seriously. Not admitted to hospital even though symptoms were worse and blood pressure higher on discharge, well above her normal levels. Currently trying to get them to explain why they took so long to do anything for her. Finally did a chest x-ray on 22Apr2021:discharge papers say abnormal x-ray and they gave a couple of different possibilities as to what that might be so Primary Care Physician wrote a prescription to get a follow-up chest x-ray to make sure that everything is fine and back to normal and not ongoing or progressing or anything because they gave some strange things: what their impressions were: findings: there is non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia. It says the left lung appears clear; cardiomediastinal silhouette is within normal limits; impression restates non specific right findings there is non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia. This was from front and lateral views of the chest x-ray at 19:00pm 22Apr2021. 2 ECGs: She guesses this is what they call EKG not, relevant point is that in the notes there for the records: Says abnormal ECG compared with blah blah blah, hard to find when exactly they wrote this, trying to get the exact wording for each of the two. Machine results CED, which caller explained is what they call themselves now instead of ER, notes for MD interpretation; one done at 17:53 , other at 21:32. They both say there was slightly different readings, however both say abnormal ECG. One of the wordings that is in both. She had no further details to provide regarding relevant testing/investigations. She had to be in the ER back in the room for several hours before they would do the EKG and that's only because she said I have chest pain and standard procedure is to do an EKG, had been back there for hours, they had done no tests, the only thing they did was basic blood panel, had not done a troponin or heart enzymes test, had not done EKG that's why she knows they were not taking her seriously at all; if someone says chest pains and you don't do anything in the standard protocol they are not taking you seriously. On this Monday, 2 days ago she had gone down to pick up the records from the ER to go to Primary Care Physician appointment 27Apr2021, finally actually got to speak to someone who said they would get back to her on 27Apr2021 to look into why the EKG tests were not done for someone having chest pains. That's one of the first things you do for someone having chest pain, no matter what the source. Frustrated with them because they're still not communicating back, they had not taken her seriously while she was there; unknown if they were actually going to be reporting, as they were still trying to convince her to get the second dose of Pfizer Covid-19 Vaccine. If she reacted to the first dose in first 10 minutes, second dose could be much more of a reaction. With the amount of anti-histamines in her system with Benadryl and Zyrtec and she was still starting to react in under 10 minutes. It's possible to be one of the inactive ingredients but she doesn't see anything in the pamphlet provided that she could identify at first glance as being the culprit to the problem other than 2 possibilities: potassium chloride and other is monobasic potassium phosphate. There is a possibility of her having a reaction to those because she was known to react to certain potassium products; sometimes it was the inactive ingredients. She definitely would have wanted to get the second part of the Pfizer Covid-19 Vaccine series until after she was not getting the medical attention she needed after reaction to the first dose. Because ideally you're supposed to have it at the same location, that just made her very nervous at the prospect of worse reaction at location that did not take her serious the first time. She was a big fan of Pfizer thought they do a great job; she had not known it was a 2 parter, not that it should make much difference. When her Primary Care Physician was saying second dose of Pfizer Covid-19 Vaccine was out of the question and she had been saying to people that she did not think it would be prudent to take the second part, they kept trying to say oh you need to get the second part, talk to so and so so they can convince you to get it, and doctor is going no. She reacted to ringers lactate or lactated ringers whatever the name is, her retired nurse sister sat and watched her getting some ringers lactate prior to surgery for her tear duct and saw her starting to break out in red splotches, patient said she was itching. Action taken in response to the events was drug withdrawn. The outcome of the events was reported as unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
61 2021-05-14 swelling local swelling, redness, itching, warmth
61 2021-05-17 swelling face hives on her mucous membranes/got a few hives on shoulder; bumps; then itching inside nostril and ot... Read more
hives on her mucous membranes/got a few hives on shoulder; bumps; then itching inside nostril and other mucous membranes/whole mucous membrane area down there still feels sensitive or irritated or something/burning feeling in mucous membranes, itching and stinging; then itching inside nostril; hives/red flushy skin/itching; touches something like the remote, patient felt very cold; itching on forehead and on back and on shoulder and in other places/itching; flushing; At first had a funny taste in mouth right away; did have diarrhea a lot when first got home; By evening face was flush red; face was probably a little bit puffy; even today every so often where hair touches face is sensitive/All openings to body are sensitive; mucous membrane area down there still feels sensitive or irritated; got goosebumps right away; burning feeling in mucous membranes; stinging; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: ER8736), via an unspecified route of administration in right arm on 28Apr2021 08:15 (at the age of 61-years-old) as 1 st dose, single for covid-19 immunisation. No prior vaccinations (within 4 weeks). No family medical history relevant to the events. No additional vaccines administered on same date of bnt162b2. Medical history included strong reaction to bee stings, allergies/some nuts, allergies/shellfish, allergies to a sulfa drug, allergies, hives, red flushy skin and itching (noted from all allergies that never had anaphylaxis before but gets hives or red flushy skin and itching from some or all of these). There were no concomitant medications. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced allergies. The patient received the first dose of bnt162b2 yesterday (on 28Apr2021 at 08:15) and had a reaction to it. The site of the injection for first dose was fine, nothing around the site. On 28Apr2021, the patient experienced at first had a funny taste in mouth right away (vaccination facility said they had never heard that before; gone momentarily after first dose/went away completely); then itching inside nostril and other mucous membranes (within five minutes of receiving the first dose); by evening face was flush red (coloring part was completely gone away); face was probably a little bit puffy; even today every so often where hair touches face is sensitive and will get itchy again; did have diarrhea a lot when first got home (lasted 15-20 minutes and then it was over); right away had itching on forehead and on back and on shoulder and in other places; whole mucous membrane area down there still feels sensitive or irritated or something. All openings to body are sensitive; continued to have burning feeling in mucous membranes, itching and stinging. Skin was really sensitive, when patient felt warm if pushed up sleeves, arm got a little cool and got goosebumps right away. If the patient touches something like the remote, patient felt very cold, skin seemed very sensitive all over. The patient took temperature to see if had a fever, temperature was 98.6, exactly normal, usually runs lower than that but definitely wasn't a fever. The patient left the vaccination facility after half an hour, nothing seemed life threatening. On 29Apr2021, the patient experienced that even today overnight got a few hives on shoulder, back up by shoulder area on one side and noticed the bumps, felt where the bumps were but they are not as big and they were itchy occasionally but not very itchy. (were better now). The events did not require emergency room or physician office visit. The patient stated that it wasn't anaphylactic reaction. The patient have read online that if have a reaction in less than four hours, it was considered severe. The patient was a little concerned when got the shot and was reassured at the vaccination facility that they had not seen anaphylaxis. The patient was wondering if it was okay to get the second dose or should the caller hold off. The patient asked if her symptoms were categorized as a severe allergic reaction (in 2021) and thereby contraindicate her from getting her second dose. The outcome was recovered from taste disorder and diarrhoea on 28Apr2021, from flushing and swelling face on 29Apr2021, from erythema in 2021; recovering from pruritus, piloerection, skin disorder and sensitive skin; not recovered from mucosal pain, burning sensation mucosal, pain, mucosal disorder and nasal pruritus while unknown for the remaining events.
61 2021-05-19 swelling face After vaccine, 2 hours later my eyes, lips were swollen. They said acute dehydration and my heart st... Read more
After vaccine, 2 hours later my eyes, lips were swollen. They said acute dehydration and my heart started pounding wildly. I went home and took Benadryl the next day I had breathing problems, 3rd day woke up with numb arm and went to ER and developed arm and left numbness and tingling that's still there today. I still have swelling in face and tongue and sores in my mouth and I have to ice myself at bedtime. and still wake up with difficulty breathing. I'm scheduled for an MRI because doctors said it's an adverse event to vaccine and I've also had hives. I will probably go back to ER because I'm having asthma issues again. I checked with my doctor about my medical records to know if I should get the vaccine and was told to get the vaccine. I have left side numbness and that's why I'm getting the MRI to rule out everything.
61 2021-05-21 high blood cell count Patient received 2nd Pfizer COVID Vaccine on 05/07/2021 and patient reports two days later she began... Read more
Patient received 2nd Pfizer COVID Vaccine on 05/07/2021 and patient reports two days later she began to feel increasingly short of breath and was found to be hypoxic at 66% requiring increased supplemental oxygen, thought to be due to sudden COPD exacerbation, requiring IV Solu-medrol, Duo-nebs and Albuterol. Required hospitalization for 2 days and discharged on antibiotics and prednisone.
61 2021-05-23 lymph node swelling Lymph nodes in neck glands swelled causing it difficult to swallow. Joints have been achy for weeks.
61 2021-05-26 peripheral swelling Adverse symptoms: bilateral lower leg / ankle swelling. Pt said that she experiences bilateral leg... Read more
Adverse symptoms: bilateral lower leg / ankle swelling. Pt said that she experiences bilateral leg swelling after immunizations.
61 2021-05-27 swelling body swelling; Swollen joints; Ulcers in her mouth; Migraine headache; Constant diarrhea; Brain fog;... Read more
body swelling; Swollen joints; Ulcers in her mouth; Migraine headache; Constant diarrhea; Brain fog; This is a spontaneous report from a contactable consumer reporting for herself. A 61-years-old 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 20Apr2021 09:00, at 61 years of age, (Batch/Lot number ER8737) as single dose for COVID-19 immunization. Medical history included thyroid disorder from an unknown date and ongoing (she has had it for years), hypertension started about 8 years before this report and ongoing, immunodeficiency from an unknown date and ongoing, her spleen has been removed and she is immune compromised and has had COVID. The patient reported that after the first dose of Pfizer-BioNTech COVID-19 mRNA Vaccine administered on 30Mar2021 at 09:00, she had mild diarrhea, body aches, fever and headaches and she felt she had COVID. The patient's concomitant medications were not reported. In Apr2021 the patient experienced body swelling, assessed as medically significant, swollen joints, ulcers breaking out inside her mouth and a 24 hour migraine headache. Ulcers started about 3 days in from the 2nd dose, they come and go. She keeps them at bay by using Listerine. She understands that whatever is happening in her lower gastrointestinal tract is coming up into her mouth. The patient added she is a neuro-muscular therapist and had an understanding of how her body works. The body swollen started a week after the shot (also reported as immediately after the shot). It continues at the time of the report and it is persisting. The patient stated "she has a little bit of COVID brain". Moreover, the mild diarrhea after the first dose changed to constant diarrhea after the second dose. It is water and with intense cramping and is constant. She reported she is on the BRAT diet. "It won't hold so she is living on Gatorade and white rice". Over the past week, her joints in her hands and in her body have become swollen. Horribly swollen to the point she couldn't get her pants on because her knees and ankles were so swollen. Her hands last week started swelling and the pores around her joints look like blisters. The patient added she has had severe brain fog since an unknown date which was ongoing at the time of the report. The headache has not left as well, the outcome of all the events was unknown at the time of the report. The patient has not been to the Emergency Department or her Physicians office, but was going at the day of the report. No follow-up attempts are needed. No further information is expected.
61 2021-05-28 lymph node swelling, peripheral swelling Diarrhea; Stomach pain; Stiff neck; Vertigo; Swelling of hands and feet; skin dryness and cuts appea... Read more
Diarrhea; Stomach pain; Stiff neck; Vertigo; Swelling of hands and feet; skin dryness and cuts appeared; skin dryness and cuts appeared; She did not have any smell and taste; She did not have any smell and taste; Fever; Chills; Coughing; Her lymph node glands were swollen between her legs; Right arm was of no use it was so painful it felt like it would break off of the shoulder; Nauseous; Dizzy; Difficulty walking; Exhaustion; The moisture in her skin was almost like it was sucked out and lesions started opening up almost like a papercut; Tachycardia/heart beating out of her chest; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 11:30 (Batch/Lot Number: EN6198) age at vaccination of 61-years-old at 0.3 ml single for covid-19 immunisation. Medical history included bell's palsy from an unknown date and unknown if ongoing, endometrial cancer from an unknown date and unknown if ongoing, rheumatoid arthritis from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (Penicillin allergy), rubber sensitivity from an unknown date and unknown if ongoing, illness from an unknown date and unknown if ongoing (sick for the past 11 years). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included levofloxacin (LEVOFLOXACIN) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; cyclobenzaprine (CYCLOBENZAPRINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfonamide and experienced hypersensitivity, mycin [benzathine benzylpenicillin] and experienced hypersensitivity. The 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: Hospital. On 25Feb2021 at 1230, she was dizzy, nauseous, vertigo, swelling of hands and feet, tachycardia/heart beating out of her chest, difficulty walking, her right arm was of no use it was so painful it felt like it would break off of the shoulder and her left arm was the arm she got the shot in and it had no reaction at all, she did not have any smell and taste, fever, chills, coughing, her lymph node glands were swollen between her legs and the other weird thing is that the moisture in her skin was almost like it was sucked out and lesions started opening up almost like a papercut, skin dryness and cuts appeared, she could hear the noise of it opening up on fingers it was like a popping, she had a stiff neck and like everyone she had exhaustion. The patient experienced stomach pain and diarrhea on 27Feb2021 those are the things she had and her family won't leave her alone, they think she should get the second injection but she is terrified. She has gotten no help from her doctor. No treatments were given for the events. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 28Nov2020 (Nasal Swab). The patent was not recovered from the events. No follow-up attempts are needed. No further information is expected.
61 2021-05-31 peripheral swelling, swollen extremities As of 6/1/2021, pt presented with 3 weeks progressively worsening dyspnea on exertion and associated... Read more
As of 6/1/2021, pt presented with 3 weeks progressively worsening dyspnea on exertion and associated lower extremity pitting edema up to hips and was found to have acute bilateral pulmonary emboli, including a large thrombus seen in the left main pulmonary artery. Also admitted to nausea, orthopnea, PND, chronic leg swelling no worse than usual, and a productive cough with creamy white sputum.
61 2021-06-01 lymph node swelling That evening when she laid down she had some neck soreness; she woke up she saw the swollen lymph no... Read more
That evening when she laid down she had some neck soreness; she woke up she saw the swollen lymph nodes.; She also experienced fatigue; arm soreness; This is a spontaneous report from a contactable consumer or other non-health care profession. A 61-years-old female patient received second dose of BNT162b2 (solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 21Apr2021 (at the age of 61-year-old) as a single dose for covid-19 immunisation. Medical history included ongoing lymphadenopathy three narrowing's in her neck and needs to get surgery on it. The patient's concomitant medications were not reported. Historical vaccine include first dose of BNT162b2, via unspecified route of administration on unspecified date (at the age of 61-year-old) at a single dose for COVID-19 immunisation. On 21Apr2021, on evening of same day of vaccination, the when the patient laid down, she had some neck soreness, and the next morning when she woke up she saw the swollen lymph nodes. She still has swollen lymph nodes now. She also experienced fatigue and arm soreness and she just put some alcohol on that and it resolved. Therapeutic measures were taken as a result of arm soreness. The patient was called to see if this is a side effect/ how long it lasts and She cannot get her neck injections or surgery until it resolves. The outcome of some neck soreness and fatigue were unknown, swollen lymph nodes was not recovered, , arm soreness was recovered. Information on the lot/batch number has been requested.
61 2021-06-01 sepsis Reaction began within a few hours of vaccination. Patient had fever, chills and diarrhea within a f... Read more
Reaction began within a few hours of vaccination. Patient had fever, chills and diarrhea within a few hours of receiving the vaccine. By 4:30am on 3/31 she could not walk and her legs went numb. An ambulance was called and the EMTs had to carry her out of the house. She was taken to Hospital where they started treating her for an infection but her fever went up over 103F so they ventilated her to try to control the fever. They did blood tests during that time and got the infections disease unit trying to figure out what was causing her symptoms. Doctors diagnosed sepsis. They continued to do blood test and cultures but could not determine the cause. They did MRIs as follow-ups because she was not responding. The fever never went down. She was awake for a few days (ventilator still in) and then started getting worse again. This is about 1.5 weeks post vaccination. They did an MRI and found a bleed on her brain and the infection had spread to her heart valves. Symptoms began within hours of vaccination. She was take to the hospital the morning after the vaccine and never came home. Patient died after 2 weeks in the ICU.
61 2021-06-02 lymph node swelling The adverse reaction was swollen left facial gland. I did not seek treatment. I placed a warm compre... Read more
The adverse reaction was swollen left facial gland. I did not seek treatment. I placed a warm compress on my face. I lasted for about 6 hours.
61 2021-06-03 swollen extremities Severe underarm and left breast swelling that lasted 5 days with pain, chills, fever, body aches and... Read more
Severe underarm and left breast swelling that lasted 5 days with pain, chills, fever, body aches and fatigue still present 7 days later
61 2021-06-03 sepsis bleed on her brain; the infection had spread to her heart valves; she could not walk; legs went numb... Read more
bleed on her brain; the infection had spread to her heart valves; she could not walk; legs went numb; sepsis; fever / fever went up over 103 F; chills; diarrhea; This is a spontaneous report received from a contactable consumer. A 61 years old female received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7533) on 30Mar2021 (at 61 years of age), in right arm, for COVID-19 immunisation. The patient received the first dose of BNT162B2 vaccine on 09Mar2021 (lot EN6202), at 61 years of age, in right arm. No other vaccines were given within 4 weeks prior to the COVID vaccine. Medical history included connective tissue disorder - scleroderma. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included methotrexate. On 30Mar2021, within a few hours of receiving the second vaccination, she had fever, chills and diarrhea. By 4:30 AM on 31Mar2021 she could not walk and her legs went numb. An ambulance was called and the EMTs had to carry her out of the house. She was taken to hospital where they started treating with antibiotics her for an infection but her fever went up over 103 F, so they ventilated her to try to control the fever. They did blood tests during that time and got the infections disease unit trying to figure out what was causing her symptoms. Doctors diagnosed sepsis. They continued to do blood test and cultures but could not determine the cause. They did Magnetic Resonance Imaging (MRIs) as follow-ups because she was not responding. The fever never went down. She was awake for a few days (ventilator still in) and then started getting worse again. They did an MRI and found a bleed on her brain and the infection had spread to her heart valves. She died on 14Apr2021 after 15 days of hospital care and Intensive Care Unit (ICU) care. The events were reported with a fatal outcome. It was unknown if autopsy was performed. Since the vaccination, the patient had not been tested for COVID-19.; Reported Cause(s) of Death: chills; diarrhea; she could not walk; legs went numb; sepsis; bleed on her brain; the infection had spread to her heart valves; fever / fever went up over 103 F
61 2021-06-03 swelling face headache; Hands were cold; Nauseous; Swollen face; This is a spontaneous report received from a cont... Read more
headache; Hands were cold; Nauseous; Swollen face; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution. A 61-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Eke199), via an unspecified route of administration, administered in right arm on 12Mar2021 as single dose for covid-19 immunization at the age of 61-years old. Medical history included drug allergy to salidine from an unknown date and thyroid removal 2008/cancer from an unknown date. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 (Sofia 2) on an unspecified date with unknown results. The patient's concomitant medications included levothyroxine sodium (SYNTHROID), route of administration, start and stop date, were not reported for an unspecified indication taken within two weeks of vaccination. The patient experienced headache, hands were cold, nauseous and swollen face on 12Mar2021, at 16:15. The events were reported as after receiving the vaccine, headache for 2 days, swollen face 1 day; hands were cold for 2 days, and she was nauseous 3 days. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included negative nasal swab on 02Feb2021. The outcome of events were as follow: headache recovered on 13Mar2021, hands were cold recovered on 14Mar2021, nauseous recovered on 15Mar2021 and swollen face recovered on 13Mar2021.
61 2021-06-07 lymph node swelling She is worried it is a kind of blood clot.; She is worried it is a kind of blood clot.; Swollen lymp... Read more
She is worried it is a kind of blood clot.; She is worried it is a kind of blood clot.; Swollen lymph nodes in right leg; This is a spontaneous report from a contactable consumer(Patient). A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 23May2021 as 2nd DOSE, Single for covid-19 immunization. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity. No family medical history reported. The patient's concomitant medications were not reported. 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, administered in Arm left on 02May2021 as single dose for covid-19 immunization. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. It was reported that, on 26May2021, after getting the second dose of the Covid vaccine, she had swollen lymph nodes in her right leg. She was worried and asks what to do and She asked if she needs to go to Urgent Care. she is worried it is a kind of blood clot. She asks if Pfizer will call her doctor and then call her. All she had were swollen lymph nodes. They are getting big and big. She confirms they are getting bigger. No relevant tests reported. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
61 2021-06-11 swelling face Joint pain; Tiredness; muscle pain; swelling of face; swelling of throat; difficulty breathing; Diar... Read more
Joint pain; Tiredness; muscle pain; swelling of face; swelling of throat; difficulty breathing; Diarrhea; This is a spontaneous report from a contactable consumer. A 61-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 10:30 (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunization. Medical history included sjogren's syndrome, arthritis, fibromyalgia and systemic lupus erythematosus. Concomitant medications were not reported. 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-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, patient has not been tested for COVID-19. On 16Mar2021 at 18:30, the patient experienced Joint pain, tiredness, muscle pain, swelling of face, swelling of throat, difficulty breathing and diarrhea. The events were not treated. The patient was recovering from the events. Amendment: This follow-up report is being submitted to amend previously reported information: Relevant Med History 2, the verbatim was updated from Arthritis NOS to Arthritis and Relevant Med History 4, the verbatim was updated from Lupus syndrome to Lupus and Narrative regenerated per original source document. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
61 2021-06-14 white blood cell count increased nausea, vomiting, diahrea, body aches, low grade temperature, lethargic, yellow cast to my skin tran... Read more
nausea, vomiting, diahrea, body aches, low grade temperature, lethargic, yellow cast to my skin transported by EMS to the hospital and was given IV fluids and IV antibiotics Still having liver tests done every two months
61 2021-06-15 peripheral swelling hand swelling , difficult to make fist and bend fingers occasional wrist pain still swollen since sh... Read more
hand swelling , difficult to make fist and bend fingers occasional wrist pain still swollen since shot 4/30/21
61 2021-06-16 lymph node swelling has a mass under her left arm pit and every time she moves her arm it hurts; has a mass under her le... Read more
has a mass under her left arm pit and every time she moves her arm it hurts; has a mass under her left arm pit and every time she moves her arm it hurts; swollen lymph node; it got bigger and got black, that the black and blue is going down but the mass is still there; This is a spontaneous report from a contactable consumer. A 61-year-old female consumer (patient) received bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration on 07Jun2021 at 09:00 (61-year-old age at vaccination) as single dose in left arm for COVID-19 immunisation. Medical history reported was rash and ongoing thyroid. Patient previously took first dose of bnt162b2 on 12May2021 and experienced had side effects of massive headache and very tired that started the same day in the evening. Concomitant medications reported was levothyroxine sodium (SYNTHROID) as thyroid medicine. Caller stated that against her better judgment and what she went through with the 1st one, they told her not to get this, she got the 2nd dose and now she has a mass under her left arm pit and every time she moves her arm it hurts. Stated it was under her arm pit and hurts pretty bad and she is really worried what the drug did to her. Stated that things are going underreported, and she was really really worried. has a mass under her left arm pit and every time she moves her arm it hurts was reported as worsened. Caller stated she wished she never got it and will tell other people and doctors don't know. Stated she should have taken the chloroquine like they told her to. Caller stated she doesn't know what the hell is wrong with her now and that she was perfectly fine before this. Caller stated she had her 2nd dose on 7Jun2021 and noticed the mass under her left arm pit immediately within a few hours of getting it. stated it got bigger and got black, that the black and blue is going down, but the mass is still there. stated when she lifts her arm and puts it down it hurts pretty bad, and she was very very concerned. Caller provided that she thought it was a swollen lymph node and it was not going away and she felt it was getting worse. Caller stated she got the 1st dose in her right arm at 10am and her 2nd dose in her left arm at 9am. Pure stupidity so she would not get Covid, and she wouldn't have gotten it anyway and would never do it again and she was trying to tell her kid not to do it. Stated she doesn't trust anything that was not really approved, and she knew better. Regarding concomitant medication, Caller stated nothing different than anything else she has been taking. States she takes thyroid medicine and has been taking it for over 10 years and this has nothing to do with that. Caller stated she has a rash and nobody knows where that was from and she was on Dupixent and there is no contraindication with Pfizer according to (Withheld), and (Withheld) told her not to get the vaccine and she should have listened and they put it in writing and she should have listened because of the Dupixent and the rash and that told her oh yes all their patients that are on Dupixent are on the Pfizer as well. Caller clarified that she had the rash and was taking the Dupixent before receiving the Covid vaccines. Caller stated she had Dupoxint and she always gets that had has not had any reactions. States her last dose was the 1st week of May2021. Caller stated she can't take the flu shot and they knew that. Caller states she does not have the NDC, lot, expiry, or doses to provide as it was 20 years ago. Caller received the 2nd dose of the Pfizer covid 19 vaccine on 07Jun2021, mass under left arm pit, turned black and got bigger, the black and blue going down, but lump is bigger. Having a lot of pain, raises arm puts it down hurts pretty bad and very concerned. It's still there feels it's getting worse; her doctor doesn't know. Caller stated, when she put it (her arm) down, it feels like a huge mass under my armpit. she should never have done this. her doctor has heard that you can get swollen lymph nodes, she was not sure this was a lymph node. Outcome of the events was not recovered. Information about the Lot/batch number has been requested.
61 2021-06-16 oral herpes Huge cold sore on my upper right lip; This is a spontaneous report from a contactable consumer (pati... Read more
Huge cold sore on my upper right lip; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6203, Expiration Date: not reported) via an unspecified route of administration in right arm on 27Feb2021 18:45 as 1st dose, single dose for COVID-19 immunization. Medical history included known allergies to Penicillin and other medical history was reported as none. Patient did not receive any other vaccine in four weeks and received other unspecified medications in two 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 28Feb2021, the patient experienced huge cold sore on my upper right lip. Patient was treated with Famciclovir. The outcome of the event was reported as recovering. No follow up attempts are Possible. No further information is expected.
61 2021-06-16 peripheral swelling Her arm hurts below the vaccination site in her left arm and the center area to an inch above her el... Read more
Her arm hurts below the vaccination site in her left arm and the center area to an inch above her elbow; Fatigue; A slight cough; Her left arm began to ache and shake/left arm pain; Her left arm began to ache and shake/left arm shaking; She had arm pain when woke up the next day, and the 28th she had slight swelling; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 27Mar2021 (at the age of 61-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated on Sunday morning while taking a phone call her left arm began to ache and shake and she had to end the call. Caller states her arm hurts below the vaccination site in her left arm and the center area to an inch above her elbow. Caller states she can't use her left hand too much because it starts to ache and shake, says she was holding the phone talking to someone and after about 50 minutes her arm hurt, then 5 minutes later it started to shake and she had to stop using her hand to hold the phone. She says she had the same problem driving to work last night, she works night, she couldn't use her left arm driving for the trip because it was shaking. then she couldn't do as much of her usual work because it starts to shake and she needs two hands to do her job. She says today she also has a little bit of a cough and fatigue. The patient reported that since it was after her first dose that she had these problems she would like to know if it is safe for her to have her second dose that is scheduled for 24Apr2021. She could use her left arm now and was currently holding the phone in that hand to see if the event reoccurs. She says her arm aches above her injection site to two inches below her elbow, and when it shakes it was like her arm was having a seizure. She was used to having 4 hour phone calls to stay in touch with people and holding a phone for long periods of time was not unusual for her, but her arm could not hold it after that 50 minute call. She had arm pain when woke up the next day, and the 28th she had slight swelling by Saturday afternoon or evening, then she woke up more swelling the next day. She said this was at a mass vaccination site she got her first dose. She had a constant ache, and she hasn't taken any Ibuprofen for it. Since she has been holding the phone this call, it has begun aching more, she has been holding the phone 15 minutes, and it started to ache, but there was no shaking yet. States she is scheduled for the second dose on 24Apr2021. She would like to know if her side effects are normal and if she should receive the second dose. Outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.
61 2021-06-17 swelling face, swelling Bright red rash, intense itching, skin peeled like from bad sunburn - multiple areas. Hives - abdome... Read more
Bright red rash, intense itching, skin peeled like from bad sunburn - multiple areas. Hives - abdomen, upper back, forearms and hands. Intense extended itching! Facial, eyelid and neck swelling. Fri May 7th (last area that week) - Face and neck also developed bright red rash and itching. As rash decreased skin felt dry and papery. Did peel /exfoliate. Last area to have response.
61 2021-06-17 swelling chest was real tight and felt like her heart was going to come out of her chest; heart beating reall... Read more
chest was real tight and felt like her heart was going to come out of her chest; heart beating really fast and pumping hard; shivers; tired a lot; It could have been swollen for a while, she probably just got used to it; headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in arm left on 16Feb2021 (at the age of 61-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient medical history was not reported. Family history included patient husband has cancer and had it twice, just finished treatment, heart trouble on her dad's side. He lived to be 90 and had 2 bypasses and had clogged arteries. Patient did not receive any other vaccines within 4 weeks prior vaccinations. The patient concomitant medication included losartan at a dose of 50 mg 1x/day taken for blood pressure high, vitamin D NOS 1x/day, zinc maybe once a week, acetylsalicylic acid (BABY ASPIRIN Chewable) did not take it regularly maybe 2 or 3 times a week; ascorbic acid, cobalt sulfate, copper sulfate, ergocalciferol, ferrous fumarate, magnesium sulfate, manganese sulfate, nicotinamide, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, vitamin b12 nos, zinc gluconate (MULTIVITAMIN (16)) 2 or 3 times a week, once in a while. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E69262) via an unspecified route of administration, administered in upper arm right on 21Jan2021 at a 1st dose, single dose for COVID-19 immunization, losartan for blood pressure high (has been taking for probably 2 years), patient takes the flu shots yearly. The patient experienced tired a lot, it could have been swollen for a while, she probably just got used to it, headaches on an unspecified date in 2021, shivers on 17Feb2021, chest was real tight and felt like her heart was going to come out of her chest, heart beating really fast and pumping hard on 18Feb2021. Patient stated she is calling regarding the Pfizer Covid 19 vaccine. Patient took that and after watching things and having complications, she got on this one website and it said to call, so she did. It was her heart. After the second shot, that day, there was nothing. Then, patient had shivers the next night and then the next night it felt like her heart was going to come out of her chest. Patient was taking Benadryl because she knew it was an anti-inflammatory. After the shot, patient sat for 10 to 15 minutes, then she was gone. After the second shot, patient had shivers the second night, all night long. Then, the next night, she felt like her chest was just real tight. Patient could tell her heart was pumping hard. Patient thought it was going to come out of her chest. Patient though, she didn't know what to think. It was beating really fast and swollen like it was pumping hard. After that, patient was just tired a lot. Patient is just now getting to where she is not tired like she was. It could have been swollen for a while, she probably just got used to it. Patient did not clarify this statement but did mention swollen in regards to her heart previously. Patient is still feeling tired but feeling a little bit better. Patient was never having headaches, and she started having headaches after. It could have been weeks after but does not know exactly when it started. She has not been having them now for about a month. Younger ones don't need to be taking this. Feels like it affects the heart and with everything else they don't need. Patient had a physical examination. Patient thinks she mentioned to her the bad shivers and the heart thing. She does not know if she told her about her heart coming out of her chest. The patient received Benadryl, Tylenol, Aspirin, Advil as a treatment medication for the events. Outcome of the events was unknown. Information about Lot/Batch number was available. Additional information has been requested.
61 2021-06-18 swelling, peripheral swelling Arm being swollen but underneath the arm in my armpit I notice it's pretty swollen; Under my arms it... Read more
Arm being swollen but underneath the arm in my armpit I notice it's pretty swollen; Under my arms it's swollen; Arm being swollen but underneath the arm in my armpit I notice it's pretty swollen; Under my arms it's swollen; Arm is sore; Chills; Headache; Fever; Tired; First it started of with I think it was tiredness, 'jerking' and then fever."; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0217) via an unspecified route of administration in Arm on 11Jun2021 as second dose, single for COVID-19 immunization. Medical history included Blood pressure high from an unknown date and unknown if ongoing. Concomitant medications included vitamin d, paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported, since patient had the shot. Consumer stated Dose of Vitamin D as it for High blood pressure medicine further clarification was unknown. It was reported that the patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0177) via unspecified route of administration on 18th May 2021 as 1st dose, single for covid-19 immunization. It was reported that the patient did not receive any vaccine within 4 weeks prior to the COVID 19 Vaccine. Consumer stated she was calling regarding a side effect that she noticed after she had her shot-on Friday the 11th of this month (11th june2021) and stated she had all the symptoms except for a few started Saturday on 12jun2021, her arm was sore and she had the chills and when she went to bed, had headache. First it started off with she thinks it was tiredness, jerking and then fever and still experiencing. On 13jun2021, she noticed that her arm being swollen but underneath the arm in her armpit she noticed it was pretty swollen under her arms and confirmed the name of the vaccine as Pfizer Covid 19 vaccine and patient stated no treatment was received and took Tylenol before vaccination. Reporter seriousness for all the reported events as unspecified. There was no investigation assessment. The outcome of the events was not recovered.
61 2021-06-22 swelling face This morning, approximately 48 hours after her COVID vaccination, patient states she woke up with sw... Read more
This morning, approximately 48 hours after her COVID vaccination, patient states she woke up with swelling on her cheek and under her left eye, which progressed to her forehead. She sought medical attention from her PCP's office since she was unsure of what was happening. They told her they felt it was related to the vaccination and prescribed an antihistamine.
61 2021-06-24 anaphylactic reaction Patient presented to the ED immediately after receiving dose 1 of vaccine with anaphylactic reaction... Read more
Patient presented to the ED immediately after receiving dose 1 of vaccine with anaphylactic reaction. Patient had hives, difficulty swallowing. was given epinephrine, prednisone taper and benadryl.
61 2021-06-28 fluid retention On March 31 I woke up and had a hard time breathing. My DR told me to go to the ER immediately so I ... Read more
On March 31 I woke up and had a hard time breathing. My DR told me to go to the ER immediately so I did. So when I got there, I was put on the bypap and had the respiratory issue, my EKG changed where I had heart problems. My liver enzymes were elevated and my kidney enzymes were elevated. I gained 10 pounds of fluid in three days of being in the ER. I went to intensive care for worsening conditions, ended up having severe migraines and not being able to see correctly. They gave me Benadryl 50mg IV along with epinephrine, all within the first two days. I was in the hospital for a week that I can tell you. Within three weeks later my liver enzymes did go back to normal. I did go to my PCD for follow up, I saw an allergist specialist as well. I couldn't walk correctly, and had a hard time breathing as well. It was like all my organs were affected. Even right now I am still fatigued and I only got the first vaccine, back in March. These all are worsening symptoms as well. I also lost my hair as well. All my nails broke, it was just like, everything happening at once.
61 2021-06-28 swelling face About 40 minutes after vaccination, started a tingling in the right side of my face tongue and chee... Read more
About 40 minutes after vaccination, started a tingling in the right side of my face tongue and cheek, throat closing, swollen lips and face on right side. Swollen in areas of the right side of my face. I called urgent care who said start Benadryl every for hours. Found I was allergic to polysorbate 80.
61 2021-06-29 lymph node pain Itchiness; redness on arm below injection point; tenderness and around lymph node under arm.; pain u... Read more
Itchiness; redness on arm below injection point; tenderness and around lymph node under arm.; pain under arm; Hard knot at injection site; Hard knot and tenderness at injectionpoint; This is a spontaneous report from a contactable consumer, the patient. A 61-year-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 right arm on 18Mar2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN) taken from unknown dates for unknown indications. Prior to vaccination, on an unknown date, 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, the patient was not diagnosed with COVID-19. On 18March2021, the patient experienced a hard knot and tenderness at injection site; on 19Mar2021, experienced pain under arm; on 20Mar2021, redness below injection point and tenderness around lymph node underarm and 3-4 days later to vaccination, experienced expanded redness on arm below injection point with pain and itchiness. Therapeutic measures were not taken as a result of the events. The clinical outcome for events vaccination site lump, vaccination site tenderness, armpit pain, itchiness, redness and lymph node tender were recovering. No follow-up attempts are possible. No further information is expected.
61 2021-06-29 lymph node swelling Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Sw... Read more
Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Swollen lymph nodes; This is a spontaneous report received from a contactable consumer, the patient. A 61-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 on left arm on 18Mar2021 at 09:45 (at the age of 61 year) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, asthma and food allergy (some food sensitivities). The patient received unspecified medication within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration on left arm on 25Feb2021 at 09:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Past drug history also included DEMEROL for which patient developed allergy. 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 18Mar2021 at 15:30, the patient experienced vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell and swollen lymph node. No therapeutic measures were taken in response to the events. The clinical outcome of the events vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell and swollen lymph node were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
61 2021-06-29 lymph node swelling Discomfort at injection site; Lymphadenopathy; Nausea; Headache; Severe fatigue; This is a spontaneo... Read more
Discomfort at injection site; Lymphadenopathy; Nausea; Headache; Severe fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included ovarian cancer, diabetes, hypertension and adhesives allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. 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. On 18Mar2021 at 16:00, the patient experienced severe fatigue, headache, lymphadenopathy, nausea and discomfort at injection site. The patient did not receive any treatment for the events. 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 events of severe fatigue, headache, lymphadenopathy, nausea and discomfort at injection site was recovered on an unspecified date in Mar2021. No follow-up attempts are possible. No further information is expected.
61 2021-06-30 lymph node swelling On 4/1, 7 days after the vaccine, the back of my head started itching. Then my neck itches. I has so... Read more
On 4/1, 7 days after the vaccine, the back of my head started itching. Then my neck itches. I has some swollen lymph nodes in the back of my neck. On 4/10, a rash began on my left forearm. It was extremely itchy. On 4/11, it was on my left and right forearm and my chest and legs. Since then it has spread everywhere. By spots, I mean it starts as a spot but then turns into a big rash. There was a rash with 2 weeks and 2 days past the vaccine and since then the rash has spread all over my body. It was awful, I did not ever have skin problems. On 4/19, I went to the dermatologist who prescribed a steroid cream. On 5/11, I went to an allergist/immunologist, he also agreed that it was from the vaccine. I have no idea how long this will last since it is in my body. The itching is much more tolerable now. It itches more in the mornings but it is not such a nuisance now. It has gone in some areas but new ones do keep coming. I'd like to emphasize that this still going on. This is a rash that has been going on since it started. Dermatologist
61 2021-06-30 peripheral swelling, swelling, lymph node swelling arm puffiness; her left breast was swollen; had a lot of arm aches where the injection site was; Bod... Read more
arm puffiness; her left breast was swollen; had a lot of arm aches where the injection site was; Body aches; swelling in her lymph nodes; had some nerve tingling in her finger; Arm swelling; swelling under her left side of the arm, the left armpit; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9264, expiry date unknown), via an unspecified route of administration in left arm on 04Feb2021 at 17:30 in the beginning of February (at the age of 61 years old) as single for COVID-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3302), via an unspecified route of administration in left arm on 14Jan2021 in the middle of January (at the age of 61 years old) for COVID-19 immunization and experienced no reaction. Medical history included headache. No family medical history relevant to adverse events was provided. No concomitant medications were reported. Patient occasionally took Excedrin or Avil expectorant for headaches and experienced no reaction on previous exposure to drug but did not take any prescription medication. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient did not administer any vaccine on same date with the Pfizer vaccine considered as suspect. Patient had no problems with the first injection received on 14Jan2021; all the events started after she received the second dose of the vaccine. On 05Feb2021, patient had body aches. 14 or 15 hours after the injection, patient's arm started aching. Patient had a lot of arm aches on the injection site. Patient took Tylenol for the body aches, which lasted a few hours and recovered on 05Feb2021. Patient was having a lingering symptom. On 06Feb2021, patient's left arm, in the armpit, had puffiness, it was not sore in the tissue and she did not know if it is the muscles or tissue. Patient had swelling under her left side of the arm, the left armpit and noticed the lymph node and got scared. Her arm really hurt on the third day and it was worse than the second day. Swelling eventually went down but not completely. She said it stayed the same and she has not noticed any more improvement for the last few months. She kept thinking it would go down more but it was the same. Patient stated that no one would notice the swelling, but she noticed a protrusion when she lifted her arm up. It did not hurt it was just there. When she lifted her arm up, the left arm was noticeably different than the right armpit. Patient's left breast was also swollen with the whole site near the armpit on 06Feb2021. Swelling started to go down but it took days. Patient had some nerve tingling in her finger on the left side and maybe in her arm, which did not last long, and she figured it was from the swelling pushing on the nerves. She did not notice it that weekend, so it might have been a few days after the weekend when she received the second vaccine. Patient had a gynecologist appointment at the beginning of April and gynecologist did not seem to be concerned, he said it could be her lymph node. Patient did not feel like she needed to go see a doctor because most of the swelling had gone down and just the lingering puffiness was still there, and she kept thinking it was going to go away and it just needed a few weeks. Swelling still had not gone down and patient had given it a few months. Events did not require a visit to emergency room or physician office. No relevant tests were performed. Outcome of the events swelling in her lymph nodes was unknown while of arm puffiness was not recovered. Outcome of the events her left breast was swollen, Arm swelling and swelling under her left side of the arm, the left armpit was recovering. Events "had a lot of arm aches where the injection site was and had some nerve tingling in her finger" recovered on an unspecified date.
61 2021-06-30 swelling face, peripheral swelling my face swelled up like a balloon, it turned burnt red, it was burning/redness; my face swelled up l... Read more
my face swelled up like a balloon, it turned burnt red, it was burning/redness; my face swelled up like a balloon, it turned burnt red, it was burning; My arms swelled up like balloon; Red rash all over my arm; allergic reaction; her face and ears had swollen up like a balloon; her face and ears had swollen up like a balloon; arms were burning and swelling; arms were burning and swelling; had a rash in the arm and neck; This is a spontaneous report from a 61-year-old female contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 21Mar2021 at 09:30 as 1st dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 21Mar2021, patient received Pfizer Covid19 vaccine first dose on Sunday at 9:30 a.m. and 2 hours later at around 12 o'clock she experienced that her face and ears had swollen up like a balloon, arms were burning and swelling, had a rash in the arm and neck, they took her to the ER and gave her Epinephrine and Benadryl. Some doctors advised not to get second one and some others advised it was not an allergic reaction and wanted to know if this was an allergic reaction to the vaccine or not. On 09Apr2021 it was reported that her face was red like someone burnt her. It was burning. She was taken by ambulance to the emergency room. Her face was hot, burning, burnt red like she had been in the sun for 4 days, and became red like she had a third-degree sunburn. They took her to the Emergency Room. She developed bilateral arm swelling 5 minutes after the vaccine. She still has a little rash. Her face was a little puffy yesterday but is better today. She only ate in the morning and didn't eat lunch before the vaccine. About 2.5 hours of vaccine administration later her face started swelling, redness, with burning. Both arms started to swell with a rash developing. Caller has seen two providers who said the symptoms were allergic reactions to the vaccine. She also seen two other providers who said it was not a reaction to the vaccine. Caller asking if she should take the second Pfizer Covid 19 vaccine. Patient is confused about getting second dose. It was reported that my arms swelled up like balloon; Red rash all over my arm and just wanted to know if she should get her second shot and asked whether she was getting the second shot on Monday or not. The clinical outcome of the event her face and ears had swollen up like a balloon, arms were burning, and swelling was resolved, the event had a rash in the arm and neck was resolving and rest of the events was unknown.
61 2021-07-01 lymph node swelling Enlarged lymph nodes
61 2021-07-01 swelling face Shingles on left side of face under eye down to lip. Swelling. Severe headaches, fatigue and weight ... Read more
Shingles on left side of face under eye down to lip. Swelling. Severe headaches, fatigue and weight loss. shingles has subsided but all other symptoms are still there.
61 2021-07-04 lymph node pain, lymph node swelling Swollen lymph nodes in the left shoulder area/upper chest, very painful to touch. Still larger than... Read more
Swollen lymph nodes in the left shoulder area/upper chest, very painful to touch. Still larger than normal, but with no pain. Strange nerve pains, shooting down left arm (only a few times, couldn't wear my fitbit because it seemed more frequent with it on); has settled down since then. I've been in menopause for 14 years with no hot flashes,etc.; I started having hot flashes again after the second shot. I've been more tired than normal and not felt 100% healthy since the second shot.
61 2021-07-06 anaphylactic reaction Anaphylaxis; Rash; urticaria; This is a spontaneous report from a contactable Physician. This Physic... Read more
Anaphylaxis; Rash; urticaria; This is a spontaneous report from a contactable Physician. This Physician reported in response to other health professional letter [sent to physician] via follow-up. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8732) via intramuscular in the right deltoid on 12Apr2021 (at the age of 61-years-old) as dose 2, single for covid-19 immunisation. Medical history included history of previous allergies to PNC (penicillin), codeine, amitriptyline and latex. Patient received antihistamine for the treatment of allergies. Concomitant medications included trazodone, vitamin C (ascorbic acid), calcium citrate, linum usitatissimum seed (FLAXSEED), topiramate (TOPAMAX), zolmitriptan (ZOMIG), norethindrone (norethisterone), ethestradiol (desogestrel, ethinylestradiol (ETHISTREL)), esomeprazole sodium (NEXIUM), valaciclovir hydrochloride (VALTREX), linaclotide (LINZESS), cyanocobalamin (VITAMIN B12), and colecalciferol (VITAMIN D) all taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP7534), via intramuscular in the left deltoid on 22Mar2021 (at the age of 61-years-old) as dose 1, single for covid-19 immunisation and on an unknown date in Mar2021 patient had rash/hives. The patient did not receive any recent vaccines, for any other conditions and for SARS-CoV2 other than Pfizer-BioNTech Covid-19 Vaccine, prior to the event being reported. On 13Apr2021, the patient experienced anaphylaxis with signs and symptoms rash and urticaria. First saw patient on 13Apr2021, 1 day after 2nd dose, she reported rash/hives since 1st dose in Mar. The patient required medical intervention with corticosteroids and antihistamine. It was reported that Pfizer product had a causal effect to the adverse event. The outcome of all the events was recovered in 2021. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Anaphylaxis, rash, urticaria and the suspect drug BNT162B2.
61 2021-07-06 lymph node swelling, peripheral swelling Swelling, erythema and pain right upper extremity associated with fever, chills, weakness and fatigu... Read more
Swelling, erythema and pain right upper extremity associated with fever, chills, weakness and fatigue. Swelling extends from shoulder to mid humerus and extend from the axilla down to the level of the breast. Large palpable mass adjacent to right breast. Seen in PCP's office on 6/29/21. Started on Bactrim without responce. Currently on Clindamycin
61 2021-07-06 swelling face, peripheral swelling It did not matter where or how hard the doctor hit here right knee; She has complications with havin... Read more
It did not matter where or how hard the doctor hit here right knee; She has complications with having no taste; She was itching on her right arm, wrists and fingers; She was tomato red from head to toe; Her throat and face was swollen; Her right hand and arm was swollen; She began having vagina spasms. She literally felt like half of a fish was inside of her vagina, and it was flopping around.; Her chest felt heavy; Her right knee had no reflex what so ever.It did not matter where or how hard the doctor hit her right knee, it did not move; The bubble blisters on her wrist; She started getting bubble blisters on her arms, fingers, and over her chest, above her boobs; Her left but cheek, back of leg and knee cap all felt numb, but also felt on fire at the same time. It just really hurt; Excruciating pain in her left butt cheek, back of leg, and knee cap; Her urinary tract started burning. She was peeing, and peeing and peeing. She was using the bathroom a lot; her urinary tract started burning. She was peeing, and peeing and peeing. She was using the bathroom a lot.; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient (self-reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 13:00 (Batch/Lot Number: ER8737) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergy to shellfish and allergy. Concomitant medication included estrogens conjugated (ESTROGENS CONJUGATED) taken for an unspecified indication, start and stop date were not reported. She received the first dose of the covid vaccine on Thursday, 01Apr2021. She felt fine over the weekend. By Monday evening, 05Apr2021, she started not feeling very good. She received her covid vaccine in her right arm. Around 1:00, her left butt cheek was in excruciating pain, then the pain spread to the back of her leg, and to her knee cap. Her left but cheek, back of leg and kneecap all felt numb, but also felt on fire at the same time. It just really hurt. By 4:00PM, she was hurting so bad, and it moved to her vagina and left leg. It did not bother her right leg. It was only bothering her vagina, butt cheek and left leg. About 16:00 to 16:30, her urinary tract started burning. She was peeing. She was using the bathroom a lot. Her husband came home around 5:30PM and co convinced her to take a hot shower. By 8:00PM, she could not take it anymore. She sent her husband to go get her something for a urinary tract infection. Her husband got her some cranberry juice, and over the counter AZO medication for urinary tract infection. Her back of leg was hurting. She had her husband look at it, but nothing showed up. She did not know that you could not see a blood clot visually. She laid on the sofa and fell asleep. About 1:00, she woke up itching. She was itching on her right arm, wrists and fingers (medically significant). She went to the bathroom, and woke her husband up because from head to toe she was tomato red. She took some Benadryl and went back to her bed. She was still in pain in her left leg, butt cheeks and vagina. She began having vagina spasms. She knows that what she is about to say sounds gross, but she does not know how else to describe it. She literally felt like half of a fish was inside of her vagina, and it was flopping around. She stayed awake and was worried. She was thinking about going to the hospital. She called her doctors on call number, and her they told her to go see her doctor first thing the next morning. Her throat and face were swollen also. She was still red all over. She has shellfish allergies. Her chest felt heavy also. Her doctor looked her over and checked for a urinary tract infection. She took AZO over the counter medication, so the urinary tract infection did not show up. Her tests did grow cultures, but no urinary tract infection showed up. While she was at the doctor, the doctor checked her reflexes. Her left knee had a reflex. Her right knee had no reflex whatsoever. It did not matter where or how hard the doctor hit here right knee. She saw a nurse practitioner, not a doctor. The nurse practitioner did not want to give her a steroid shot. The nurse practitioner wanted her to hold on to as much of the covid vaccine as possible. The nurse practitioner told her to take four Benadryl's a day until her symptoms stopped. She got about 16 minutes from her doctor's office, and she started getting bubble blisters on her arms, fingers, and over her chest, above her boobs. The bubble blisters lasted for two days. Now she has red spots where some of them were. She went to the doctor on a Tuesday. The bubble blisters did not alleviate until Saturday or Sunday. She was told not to get the second dose of the covid vaccine. Her symptoms after the first dose were scary. Her doctor said that she did not have an urinary tract infection, but her sample grew cultures. Her doctor told her that her urinary tract burning had nothing to do with covid. She is an esthetician, she does facials. She knows of three or more people that are her age, in their 60s that have not had a urinary tract infection for the past 25 years. Those people all had a urinary tract infection after getting the covid vaccine. No further information provided. Her symptoms began on Monday, 05Apr2021. Over the weekend, her arm was extremely sore. Excruciating pain in her left butt cheek, back of leg, and kneecap: Her left but cheek, back of leg and knee cap all felt numb, but also felt on fire at the same time. Began on 05Apr2021. It began as a tingle. She knew that it was hurting a lot. At first, she could not pinpoint what it was. The pain moved to her vagina and left leg: Clarifies that it moved down her left leg, over her vagina, to her knee cap. It kept going and stopped at her other leg. She takes Estrogen vaginally. She states that Benadryl helped slow down all of that down. 08Apr2021 through 11Apr2021, she was recuperating. She has complications with having no taste: She does not taste metal, or anything. She feels like she is having trouble cooking, but her husband tells her that her cooking has been wonderful. The food she makes tastes horrible to hear. She feels like her sense of taste is getting a little bit better. Her urinary tract started burning. She was peeing and peeing and peeing. She was using the bathroom a lot: Began about 16:30. She did not have an urinary tract infection, but her sample did grow cultures. She was prescribed Amoxicillin on 07Apr2021. Her symptoms had lessened by 07Apr2021. She does not know if she needed the Amoxicillin. 07Apr2021 through 09Apr2021, she felt so much better. She was itching on her right arm, wrists and fingers: Began about 1:00 on 06Apr2021. She took four Benadryl a day. The itching was annoying to her in certain spots. The itching lasted through 13Apr2021 or 14Apr 2021, she is not sure the end date. She was tomato red from head to toe: Began about 1:00AM on 06Apr2021. It went away 08Apr2021 or 09 Apr 2021. The redness went away the same time as the swelling. Her throat and face was swollen: Began about 1:00 on 06Apr2021. It went away 08Apr2021 or 09Apr2021. Her right hand and arm was swollen: Began about 1:00 on Apr 06 2021. It went away 08Apr2021 or 09Apr 2021. She began having vagina spasms. She literally felt like half of a fish was inside of her vagina, and it was flopping around: Her vagina hurt before she went to sleep. But the spasms did not start until the middle of the night. The spasms lasted all day, for a good ten hours. The vagina spasms have not happened again. Her chest felt heavy: Began about 1:00 on 06Apr2021. Her right knee had no reflex whatsoever. It did not matter where or how hard the doctor hit her right knee, it did not move: Began Tuesday, 06Apr2021. Now she thinks that her knee is just fine. It was just weird. She started getting bubble blisters on her arms, fingers, and over her chest, above her boobs: The bubble blisters lasted for two days. Now she has red spots where some of them were. The bubble blisters lasted until the evening of 07Apr2021. Most of the bubble blisters have went away. The bubble blisters on her wrist went away around 08Apr2021. Indication was she has three children. One of her children is an extreme democrat. Her other two children are democrats. Her democrat daughter did not have anything to do with her if she did not get the covid vaccine. At her age, she could not risk it. She has a lot of junk going on. She is allergic to everything. She has five bulging discs. Her two republican daughters did not want her to get the covid vaccine, they wanted her to wait and see how it affected everyone else. Her democrat daughter was losing it. Outcome of the event She has complications with having no taste was recovering. Outcome of the event It did not matter where or how hard the doctor hit here right knee and Her left but cheek, back of leg and kneecap all felt numb, but also felt on fire at the same time. It just really hurt was unknown. Outcome of the events she began having vagina spasms. She literally felt like half of a fish was inside of her vagina, and it was flopping around was recovered on 06APR2021. She started getting bubble blisters on her arms, fingers, and over her chest, above her boobs was recovered on 07Apr2021. Excruciating pain in her left butt cheek, back of leg, kneecap and Her chest felt heavy and The bubble blisters on her wrist was recovered on 08Apr2021. Her urinary tract started burning. She was peeing and peeing and peeing. She was using the bathroom a lot was recovered on 09Apr2021. Outcome of the other events was recovered on unspecified date in APR2021. Information on Lot/Batch number was available. Additional information has been requested.
61 2021-07-06 swelling I experienced after my vaccine, I had little swelling, redness and a little tender. I also had a sli... Read more
I experienced after my vaccine, I had little swelling, redness and a little tender. I also had a slight headache that came and went. My symptoms cleared pretty fast within a few days.
61 2021-07-10 lymph node swelling Event: Malaise was reported as worsened/ Event: soreness under arm down to wrist was reported as wor... Read more
Event: Malaise was reported as worsened/ Event: soreness under arm down to wrist was reported as worsened.; She was on another medication for nausea; right tonsil area sore; right tonsil area sore/felt like the right of her throat in the tonsil was swollen; headache; Malaise over my body; swelling is affecting her tongue; aching that goes down her neck, across the shoulder blade and down her arm to the injection site; lymph glands feel tighter in her neck; soreness under arm down to wrist; soreness under arm down to wrist; This is a spontaneous report from a contactable consumer(patient). A 61-year-old female patient received first dose bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9266), dose 1 via an unspecified route of administration, administered in right arm on 08Mar2021 07:20(at the age of 61years) as DOSE 1, SINGLE for covid-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing, ovarian cancer from 1996 to an unknown date, ongoing neuropathy, ongoing complex regional pain syndrome, ongoing dry eye and ongoing fibromyalgia. Years ago she had chemo for ovarian cancer. The chemo triggered migraines. She was on Cisplatin, Bleomycin and VP 16. She was on another medication for nausea. NDC, Lot and Expiry are unknown to caller. She is on disability for several things. She developed migraines, neuropathy, complex regional pain syndrome and severe dry eyes and fibromyalgia after having the chemo and ovarian cancer. Concomitant medications included cisplatin taken for ovarian cancer from an unspecified start date and ongoing; bleomycin taken for ovarian cancer from an unspecified start date and ongoing; etoposide (VP-16) taken for ovarian cancer from an unspecified start date and ongoing. Patient did not receive other vaccination within 4 weeks prior to vaccination no relevant tests were reported patient didn't received other medications. On 08Mar2021 the patient experienced right tonsil area sore right tonsil area sore felt like the right of her throat in the tonsil was swollen, headache, malaise over my body, swelling is affecting her tongue, aching that goes down her neck, across the shoulder blade and down her arm to the injection site, lymph glands feel tighter in her neck, soreness under arm down to wrist, soreness under arm down to wrist , event malaise was reported as worsened event soreness under arm down to wrist was reported as worsened on an unspecified date, she was on another medication for nausea on an unspecified date investigation assessment was not reported. Clinical course of events: Caller received the first dose of the Covid-19 vaccine this morning. On her way home about 30-45 after receiving the vaccine she started feeling like the right side of her throat in her tonsil was swollen. She did not have any breathing problems. She was aching that goes down her neck, across the shoulder blade and down her arm to the injection site. The lymph glands feel tighter in her neck. She has a headache. She feels like she has malaise. She came home and ate. She did not experience any nausea. She did not eat before going to get the vaccine. She asked if this is normal. She did take Tylenol. The swelling seems like it is affecting her tongue. She can tell with her speech. She has a history of neuropathy. She is wondering if this could have hit a nerve. The headache just started in the last hour. She is prone to migraines. When her neck muscles get involved she gets a migraine. They could have accidentally hit a neve. The soreness keeps getting farther down her arm. Therapeutic measures were taken as a result of the events. She was on another medication for nausea. The outcome of the events tonsillar disorder, tonsillar hypertrophy, malaise, swollen tongue, pain, pain in extremity, arthralgia, was not recovered and the outcome of the event headache was recovered and the outcome of the events lymph gland infection, condition aggravated, nausea was unknown. No follow-up attempts are possible; No further information is expected.
61 2021-07-10 swelling face Face Swelling; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old ... Read more
Face Swelling; This is a spontaneous report from a contactable consumer, the patient. A 61-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 24Mar2021 at 23:15 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, diabetes, hypertension, depression, obesity, sleep apnoea, arthritis, glaucoma, psoriasis and rosacea. The patient was allergic to penicillin and sulphadrugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), aripiprazole (ABILIFY), venlafaxine hydrochloride (EFFEXOR), atorvastatin calcium (LIPITOR) and irbesartan (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date. 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. On 25Mar2021 at 08:00, the patient experienced face swelling. The adverse event resulted in doctor or other healthcare professional office or clinical visit. The patient was treated with BENADRYL for face swelling. The clinical outcome of the swelling face was resolved on an unspecified date in Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
61 2021-07-11 swelling One week following after the vaccination, my arthritis has gotten worse. I'm having cramps in my leg... Read more
One week following after the vaccination, my arthritis has gotten worse. I'm having cramps in my legs. The cramps in my legs had me go to the doctor. Doctor also notice I had more swelling were my arthritis is. I'm started taking the supplements, calcium, potassium, and magnesium, it's a combination to deal with the leg cramps. And the doctor gave me an osteopathic adjustment. The AE are disabling and impairing my function. I am also having muscle cramps in my abdomen.
61 2021-07-14 anaphylactic shock I went into antiflactic shock, brought over to the hospital, was given intravenous drugs and benadry... Read more
I went into antiflactic shock, brought over to the hospital, was given intravenous drugs and benadryl. Had to stay for 6 hours.
61 2021-07-17 lymph node swelling Ringing in ears; stiff neck; swollen lymph nodes; it is distracting me; This is a spontaneous report... Read more
Ringing in ears; stiff neck; swollen lymph nodes; it is distracting me; This is a spontaneous report from a contactable consumer, the patient. A 61-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 on the right arm on 22Mar2021 at 03:45 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included ascending aortic aneurysm. Concomitant medications were not reported. 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. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 at 03:45, the patient experienced ringing in ears, stiff neck, swollen lymph nodes and distracting. The patient also reported that ringing started 3 minutes after getting shot and it was distracting her. No therapeutic measures were taken as the result of reported adverse 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 ringing in ears, stiff neck, swollen lymph nodes and distracting were unknown. No follow-up attempts are needed. No further information is expected.
61 2021-07-17 oral herpes This is a spontaneous report from a contactable consumer, the patient. A 61-years-old non-pregnant f... Read more
This is a spontaneous report from a contactable consumer, the patient. A 61-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) on 04Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunization and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, mitral valve prolapse (MVP) and osteoarthritis. The patient did not have allergies to medications, food, or other products. 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. On an unknown date in Mar2021, after first vaccine the patient experienced cold sore - left side of tongue for a couple of days. On 25Mar2021 after Second vaccine, the patient experienced cold sore- right side of tongue for a couple of days. 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 the events cold sore (after first vaccine) and after second vaccine was recovered on an unknown date in Mar2021. No follow-up attempts are needed; information about lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021357059 same patient/drug/event occurred in different place
61 2021-07-17 peripheral swelling big red lump on side of right foot; Swelling over the bank of the ankle; Big red lump on side of rig... Read more
big red lump on side of right foot; Swelling over the bank of the ankle; Big red lump on side of right foot hurts to even touch. Left foot severe pain; Big red lump on side of right foot; Severe foot and leg pain; This is a spontaneous report from a contactable consumer, the patient. A 61-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 left arm on 18Mar2021 at 16:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and high blood pressure. The patient was allergic to doxycycline and sulfa drugs. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN), trazadone (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN) and buspar (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates. 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. Since the vaccination, the patient had not tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administartion in the left leg on 26Feb2021 at 16:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. On 22Mar2021 at 07:00, 4 days after the vaccination, the patient had severe foot and leg pain. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure taken as a result of severe foot and leg pain included tylenol (MANUFACTURER UNKNOWN), anti-inflammatory drugs (MANUFACTURER UNKNOWN) and zpak (MANUFACTURER UNKNOWN). The pain eased for a couple of days but then was back again, worse than before. On an unknown date, the patient had a big red lump on side of right foot which hurt even to touch, left foot had severe pain and swelling over back of ankle. The clinical outcome of the events severe foot and leg pain, big red lump on side of right foot which hurts, left foot severe pain and swelling over back of ankle was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
61 2021-07-17 peripheral swelling swollen wrists; swollen hands; swollen knees; red hands; severe generalized reaction of significant ... Read more
swollen wrists; swollen hands; swollen knees; red hands; severe generalized reaction of significant swelling at all extremities and face; Upset stomach; loose stool; eye burning sensation; skin peeling in both hands; This is a spontaneous report from a contactable consumer, the patient. A 61-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 10Mar2021 at 14:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient had known allergies to some food (beans, pistachios, lactose intolerant), chemicals (in respirators, formol, latex etc), environmental, (dust, pollen, some trees) and medicine (tetracycline). Concomitant medications included claritine (MANUFACTURER UNKNOWN),vitamin C (MANUFACTURER UNKNOWN) and d3 (MANUFACTURER UNKNOWN) since 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 COVID-19 vaccine. The patient experienced red hands, severe generalized reaction of significant swelling at all extremities and face, upset stomach, loose stool, eye burning sensation and skin peeling in both hands on 10Mar2021 at 14:45. The patient experienced swollen wrists, hands and knees after 19 days after the first vaccination on an unknown date. The patient received treatment for the reported events included claritin and benadryl. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events red hands, severe generalized reaction of significant swelling at all extremities and face, upset stomach, loose stool, eye burning sensation, skin peeling in both hands, swollen wrists, hands and knees were not recovered at the time of this report. No follow up attempts are needed. No further information is expected
61 2021-07-17 swelling Left arm pit swollen and sore; Left arm pit swollen and sore; This is a spontaneous report from a co... Read more
Left arm pit swollen and sore; Left arm pit swollen and sore; This is a spontaneous report from a contactable consumer, the patient. A 61-years-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 29Mar2021 at 13:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included osteopenia. The patient received other medication within two weeks of vaccination which included Vitamin D (MANUFACTURER UNKNOWN) and a Multi-Vitamin for unknown indication. The patient received vaccine within four weeks prior to the vaccination which included 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 08Mar2021 (at the age of 61-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 31Mar2021 at 17:00 the patient experienced left arm pit swollen and sore. 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 events. The clinical outcome of the events left arm pit swollen and sore was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained
61 2021-07-17 swelling Swollen armpit on left arm. The shot was given into the left arm; This is a spontaneous report from... Read more
Swollen armpit on left arm. The shot was given into the left arm; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old adult 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 61-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date received within 2 weeks of vaccination. The patient was allergic to shellfish, cats and dogs. The patient had not received any other vaccine within four 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 27Mar2021 at 00:00, the patient experienced swollen armpit on left arm. 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 the result of adverse events. The clinical outcome of swollen armpit on left arm was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
61 2021-07-18 peripheral swelling, swelling face Site: Swelling at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongu... Read more
Site: Swelling at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: patient reports on right arm had swelling as well as right side of face : cheeks, eyes will go to see urgent care
61 2021-07-19 peripheral swelling My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my thro... Read more
My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; I had a bad reaction because of any other medication consider allergic to it.; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via intramuscular route of administration in Arm Left on 14Jun2021 as single dose for covid-19 immunization. Medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medication included propanol taken for hypertension, start and stop date were not reported. In Jun2021 patient had her 1st shot of vaccine, 3 weeks ago and just, had a, she thinks, a had a bad reaction because of any other medication consider allergic to it. Her arm had a rash on it and its swollen. It was always on her arms and hands. It went up to her throat so, and she was sick right away after she had this. She had really awful three days after she had the shot. This does not mean that she was having allergic reaction, she stated. She stated she should not get the second shot. Patient stated it started hours after the shot. The person actually right away, I don't know it was the vaccine necessarily or the person giving me the shot but I am wondering if he or his arm, start turning black and blue. She doesn't have the vaccination card. 13Jun, 14Jun I guess she confirmed as 14Jun2021. Consumer stated, her second shot is due. The LOT number for the first dose, this, she can tell this person had very bad handwriting. It's look like EW0101. Treatment taken for Adverse Event with Benadryl, Diphenhydramine 50 mg, Norco 10/325 mg. Therapeutic measures were taken as a result of the events. The clinical outcome of the events was unknown. Information on the lot/batch number has been requested.
61 2021-07-22 lymph node pain Ongoing muscle aches in arm up through neck. Only on the second shot location.. Achiness continuing ... Read more
Ongoing muscle aches in arm up through neck. Only on the second shot location.. Achiness continuing and persistent 4 months later. And not improving. It's minor but noticeable. Reported initial side effects back in March but this has not gone away. In the neck area it seems as though it may be lymph nodes as well.
61 2021-07-22 peripheral swelling Numbness and tingling on lips and tongue, fatigue, throat tightening, back of thigh swelling, fever... Read more
Numbness and tingling on lips and tongue, fatigue, throat tightening, back of thigh swelling, feverish, and pain. lasted at least 3 days but resolved. All issues completely resolved in a week.
61 2021-07-27 lymph node pain, lymph node swelling Kidney pain; Jaw lymph nodes swelling; Jaw lymph nodes pain; Fatigue; Injection arm pain; This is a ... Read more
Kidney pain; Jaw lymph nodes swelling; Jaw lymph nodes pain; Fatigue; Injection arm pain; This is a spontaneous report from a contactable consumer, the patient. A 61-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 left arm on 05Apr2021 at 10:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, asthma, high bp (blood pressure high), obese (obesity), arthritis and disc problems. The patient received many unspecified medications within two weeks of vaccination. The patient previously took sulfa (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy on 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 05Apr2021 at 12:00 the patient experienced kidney pain, jaw lymph nodes swelling (swollen lymph nodes) and pain (lymph nodes pain), fatigue and injection arm pain (pain in arm). The patient did not receive any treatment for the reported 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 the events kidney pain, jaw lymph nodes swelling, jaw lymph nodes pain, fatigue and injection arm pain were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
61 2021-07-27 lymph node pain, lymph node swelling Severe pain in lymph node(s) under left arm, in arm pit; Severe swelling and pain in lymph node(s) u... Read more
Severe pain in lymph node(s) under left arm, in arm pit; Severe swelling and pain in lymph node(s) under left arm, in arm pit.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK6213) via an unspecified route of administration in the left arm on 29Mar2021 at 14:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease) from an unknown date and allergy to sulfa's. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) taken for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 08Mar2021 at 14:15 (at the age of 61-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 at 07:00, the patient experienced severe swelling and pain in lymph node(s) under left arm, in arm pit. The patient received shot on Monday and had absolutely no reaction, not even a sore arm, until she woke up on Friday morning. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of severe swelling and pain in lymph node(s) under left arm, in arm pit and included application of heat and massage (as tolerable). The clinical outcome of the events severe swelling and pain in lymph node(s) under left arm, in arm pit was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
61 2021-07-27 lymph node swelling feels crummy; Chills; a little headache; Low grade fever; a lump under her arm/has a lump under her ... Read more
feels crummy; Chills; a little headache; Low grade fever; a lump under her arm/has a lump under her right arm, this is also the injection site arm/swollen lymph node; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Right on an unspecified date as single dose for covid-19 immunization (age at vaccination: 61-year-old). Previously the patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Right on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date post vaccination, the patient woke up with chills in the morning, a little headache and a low-grade fever. The patient also reported that there is a lump under her arm, her right arm, the same arm she received her vaccine in. The lump is not at the injection site, it is under her armpit. The patient also felt crummy. The outcome of the events was reported as unknown at the time of report. Information on the lot/batch number has been requested.
61 2021-07-27 peripheral swelling Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting dow... Read more
Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; This is a spontaneous report received from a contactable other HCP. A 61-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9261), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 10:00 (at the age 61-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included thyroiditis (Verbatim: Hoshimoto's Thyroiditis), food allergy known_allergies: Stadol, Demerol, fish. Concomitant medication(s) included levothyroxine sodium (THYROXINE) for an unspecified indication. The patient previously took stadol for drug hypersensitivity, demerol for drug hypersensitivity, bnt162b2 dose: 1 (Lot: EL3248) via unspecified route of administration, administered in left arm on 14Jan2021 at 10 AM 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 has been tested for COVID-19. It was stated that "Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pain. I spent three weeks being barely able to walk or stand and unable to leave my home. It was another three weeks before I could walk 1/2 mile comfortably. I had difficulty regulating heat and cold, had hyperhydrosis, decreased appetite and lethargy. My knee and calf were swollen and discolored. I went to the ER, Physical Therapy, and finally my MD, who said it was an inflammatory reaction to the vaccine. I still have some hip, leg, and back pain. I had x-rays to confirm it was not a musculoskeletal problem. I did not hurt my back. Pain medication did little to help. Until this time, I had never had an xray. Before this I was in exceptionally good health. I have finally returned to daily walking and yoga. I am a Registered Nurse with 40-year experience and a Doctorate", in Feb2021at 05:00 AM. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Feb2021, physiotherapy: unknown on an unspecified date (inflammatory reaction to the vaccine), x-ray: unknown on an unspecified date. Therapeutic measures were taken as a result of events. Outcome of the events was recovering. Follow-Up (30JUN2021): Follow-up attempts are completed. No further information is expected.
61 2021-07-27 swelling Pain at injection site; base of neck hurt; felt a lump near my collarbone, lump was floating and mov... Read more
Pain at injection site; base of neck hurt; felt a lump near my collarbone, lump was floating and moving, hurt/tender to the touch; collar bone area swollen; This is a spontaneous report from a contactable consumer reported for herself. A 61-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for Injection, Lot number: EN6205) via an unspecified route in the right arm on 06Mar2021 at 10:00, as a single dose for covid-19 immunization. Medical history included covid-19, allergic to Lipitor, statins, high blood pressure and slightly overweight. Concomitant medications included naproxen sodium (ALEVE), minocycline, VITAMIN C (ascorbic acid), VITAMIN D (colecalciferol) and quinapril hydrochloride (ACCUPRIL). Prior to vaccination, patient was diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. On 07Mar2021 (Sunday) at 15:45, patient experienced pain at injection site, base of neck hurt, felt a lump near collarbone, lump was floating and moving, hurt/tender to the touch and collar bone area swollen. Adverse events resulted in doctor or other health care professional clinic visit. Patient went to dermatologist today felt that it may be nothing and was prescribed to minocycline a day for a week. The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
61 2021-07-27 swelling Patient mentioned she was in a lot of pain and swelling; Patient mentioned she was in a lot of pain ... Read more
Patient mentioned she was in a lot of pain and swelling; Patient mentioned she was in a lot of pain and swelling; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021093868). This case was split from master case 2021755177 for a 61 years old female patient taking BNT162B2 and experienced pain and swelling. This non-serious solicited report (USASL2021093868) was reported to Amgen on 16Jun2021 by a consumer from a commercial program (PSP00086). A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Apr2021 (age at vaccination was 61 years) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 30Apr2021 (age at vaccination was 61 years) dose 2, single for COVID-19 immunization. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No co-suspect medications were reported. The patient's concomitant medications included diclofenac (topical), calcium, Vitamin D (ergocalciferol), start and stop date unknown, taken for unspecified indication. Concomitant medications included diclofenac, calcium and ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) all taken for an unspecified indication. The patient began etanercept (Enbrel) with Reusable Autoinjector 50 milligram, qwk (lot number: 1104398, expiry date: 31Jan2023) on 02Jun2021 and (lot number: 1121827, expiry date: 30Apr2023), taken for rheumatoid arthritis. The patient experienced ran down leg/then was a few drops on floor, had stomach ache, indigestion, low grade fever while receiving Enbrel, Reusable Autoinjector. On an unknown date in Jun2021, the patient stated that she had a stomach ache after taking Enbrel, had indigestion the day she takes the injection and the day after and for two days she had a low grade fever of 98.8 and 99. The patient stated that her rheumatologist was aware. On 16Jun2021, the patient took her Enbrel injection. The patient stated when she gave her third injection today, the Enbrel ran down leg and then was a few drops on floor not a puddle. She did not remember the status button flashing green the green bars in the progress bar. The patient stated that the AT (AutoTouch) did not alarm or have a red light. She did not feel the needle stick. She thought it was uneven. No treatment information was received. The outcome of the events accidental exposure to product, abdominal pain upper, dyspepsia, pyrexia were reported as unknown. Action taken with Enbrel and Reusable Autoinjector was reported as unknown for the events abdominal pain upper, dyspepsia and pyrexia. The causal relationship between the events accidental exposure to product, abdominal pain upper, dyspepsia, pyrexia and Enbrel, Reusable Autoinjector was not provided by the consumer. Additional information was received on 01Jul2021 reported to Amgen by a consumer from a commercial program (PSP00046b) and involved a patient who stated part of the injection didn't go in, it went onto the floor, stress, flare in her knees/lot of pain, lot of swelling, while receiving Enbrel with Reusable Autoinjector. The patient stated she had five injections of Enbrel with Enbrel AutoTouch and Enbrel Mini Cartridge for treatment of rheumatoid arthritis. She had been instructed to use once a week. On an unknown date in 2021, the patient then further clarifies that she may have more like four and half injections due to she was under a lot of stress, she does not think the injection was level or even. Patient had a death in the family and her daughter had fallen and she was distracted. She did answer a bunch of questions when she stated this and she did contact her doctor and was instructed to take another dose and she just did not. Patient had been able to administer successful injections later, she had no problems with the injector. Patient stated it was a bad day, part of the injection didn't go in, it went onto the floor. The patient then mentioned that she just wants to walk. Patient was having a flare in her knees and that was why she was given the Medrol dosepak (methylprednisolone). Patient also had some diclofenac topical which she would try first. Patient stated she would like to walk and bend her knees. She had a lot of swelling. Patient had a lot of swelling and her doctor said a lot of people that didn't have underlying conditions had pain and swelling. Patient mentioned she was in a lot of pain and swelling. Patient received the Pfizer COVID-19 vaccines. The outcome of the event stress, arthralgia, joint swelling, was reported as unknown. Action taken with Enbrel, Reusable Autoinjector was reported as unknown for the events stress, arthralgia, and joint swelling. The causal relationship between the events stress, arthralgia, joint swelling, and Enbrel, Reusable Autoinjector was not provided by the consumer. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
62 2021-01-05 lymph node pain, lymph node swelling Swelling, and warmth at injection site, right arm; Swelling, and warmth at injection site, right arm... Read more
Swelling, and warmth at injection site, right arm; Swelling, and warmth at injection site, right arm; swollen and tender right axillary node under right arm; swollen and tender right axillary node under right arm; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140), intramuscular on 22Dec2020 10:30 at first single dose at arm right for covid-19 immunisation . Medical history included breast cancer, allergy to penicillin, levaquin, neosporin, cocoa butter. Concomitant medication included vitamin c [ascorbic acid]. The patient experienced swelling, and warmth at injection site, right arm, swollen and tender right axillary node under right arm on 28Dec2020 16:00. No treatment for events. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.
62 2021-01-05 peripheral swelling 1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white no... Read more
1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white noise in ears, fatigue lacinating pain ankles, knees ,wrist and finger joints; pain along nerves and vessels fingers with right fourth DIP ulnar side small vessel bleed hematoma 4 cm x 4cm swelling; NO trauma sedenatry Saw Urgent care 1/4/21 -with negative covid 19, strep and flu tests said was repsonse to vaccine Saw primary 1/5/21 Dr hopsital, said probably had covid before and was repsonse to vaccine. 1/6/21; all fingers still swollen no pain most other symptoms improving but TIRED
62 2021-01-05 peripheral swelling swelling and joint pain in the little finger on left arm; swelling and joint pain in the little fing... Read more
swelling and joint pain in the little finger on left arm; swelling and joint pain in the little finger on left arm; She got a bruise at the injection site; It bled a little bit when she put it in; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231), via an unspecified route of administration on the left arm, on 28Dec2020 at 14:15 at a single dose for Covid-19 immunization. Medical history included environmental allergies, she has allergies and can have an asthmatic attack from cat dander and perfume, blood pressure (abnormal) and sleep (disorder). Concomitant medications included ongoing lisinopril for blood pressure, colecalciferol (VITAMIN D), acetylsalicylic acid (BABY ASPIRIN), paracetamol (TYLENOL). The patient previously took novocaine but was allergic. She got all this information when she got the vaccine on Monday at (place name) in (state name). It tells all the side effects from the first injection. She wanted to report that it is the same arm that she got the vaccine in. She has swelling and joint pain in the little finger on left arm. It says you can have joint pain, but nothing about swelling. She thought she better report it. This was her first shot. She is supposed to get the second one on 18Jan2021. She wanted to make sure she can take it. She received the vaccine on 28Dec2020. She laid around that day. Today is the first day she doesn't have arm pain and swelling at the injection site. It was the first time she has had arm pain. She has never had that with flu shot. The arm pain started within the 15 minutes she was observed. It hurt like hell until that day. She got a bruise at the injection site. It bled a little bit when she put it in. Swelling and joint pain in the little finger on left arm: she doesn't know if it was later that day. She can't remember. She really noticed it yesterday. She has never had joint pain or swelling. She doesn't have any problems with arthritis. Now her little finger is bigger than the rest of her fingers. It hurts because of the swelling. She doesn't want to take anything. It might be fluid. She has a high pain tolerance. She keeps bending it thinking it will get better. It isn't as bad, but its still swelled up. At first she thought it was better, but it is still pretty swollen. To her this is a reaction. She was thinking if she took paracetamol before, it wouldn't hurt as bad, but she can't remember if she took it that morning. She takes 500mg before bed for the heck of it at night. It helps her sleep better. She has allergies and can have an asthmatic attack from cat dander and perfume. They think she was allergic to the preservative in the flu shot, but she has never had any trouble with the flu shot since. She has environmental allergies. They thought she was allergic to Novocaine once at the dentist office. Who knows, it only happened once. She's been to the dentist many times and who knows what they injected and why she reacted that way. She felt like she was going to pass out. They don't give it to her anymore. She doesn't know what was in it. She is worried since this vaccine is emergency authorization. She doesn't want to get the next one and have a worse reaction. She is not sure if she should be worried. The events of swelling and joint pain in the little finger on left arm were assessed as medically significant. Outcome of the event of 'swelling of fingers' was not recovered, the other events were unknown.; Sender's Comments: There is a reasonable possibility that the event joint pain was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the event swelling with BNT162b2 can not 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.
62 2021-01-07 lymph node swelling Patient 00037022 DOB 03-21-1958 received 2nd dose Pfizer lot EL1284 on 1-6-2021 in left arm. She ha... Read more
Patient 00037022 DOB 03-21-1958 received 2nd dose Pfizer lot EL1284 on 1-6-2021 in left arm. She has not had history of reaction before. Starting from midnight that night she has fever between 100.6-101.2, body aches and stiff neck. She also has swollen left arm pit, head ache, Pruritus breathing. She has a history of afib and last night she had two runs of it and took metoprolol.
62 2021-01-07 lymph node swelling Fine pin point rash and itching noted 45 minutes after shot given. Rash noted to neck,spine,hips,upp... Read more
Fine pin point rash and itching noted 45 minutes after shot given. Rash noted to neck,spine,hips,upper back,upper chest and bend of both arms.Benadryl 25 mg OTC 1/6/21 and 1/7/21.Itching. Itching decreasing 1/8/21. Having copious side effects also of injection site pain,tiredness,headache,joint and muscle pain,nausea,lymphadenopathy and feeling unwell.1/6/21,1/7/21 but feeing better when tylenol 500mg ing system to relieve aches and pains
62 2021-01-07 lymph node swelling Swollen lymph nodes in left ancillary and into the left breast.
62 2021-01-09 peripheral swelling About 13 hours after injection I started having extreme chills and shaking. Took 2 Ibuprofen and the... Read more
About 13 hours after injection I started having extreme chills and shaking. Took 2 Ibuprofen and the chills subsided during the night and then had mild/moderate body aches for about another 12 hours. About 48 hours after the injection the top half of my arm is currently slightly swollen, red and hot to the touch.
62 2021-01-10 lymph node swelling swelling in left axilla pain in L axilla
62 2021-01-11 peripheral swelling some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was real... Read more
some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was really scared; Excruciating pain on left ear; swelling in arm; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: ES1685, Expiry date: 01Mar2021) via intramuscular (left deltoid) on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She stated she is very healthy and don't have any medical conditions. She further stated that it was a scary moment, she don't want to take any chances, she was really frightened (28Dec2020). She made a complaint to let know her experience with the vaccine. Her cousin took the vaccine and told her she needed to report these events. The patient stated she experienced side effects after the first dose of the vaccine: Excruciating pain on left ear, locked jaw, her left upper arm was hurting on 28Dec2020. The pain went in her jaws and she was unable to open her mouth on 28Dec2020. She took 2 Benadryl and it relieved her. She saw on television if you experienced any side effects to take Benadryl. She also took Tylenol for the pain. She also had swelling in arm on an unspecified date in Dec2020. She also experienced some memory loss described as short-term memory loss on 30Dec2020. She stayed in bed after the vaccine, she was really scared, and stated she had memory loss and she don't have any memory problems. She was unable to remember if her car was black. She was looking for a white car. She drives a black car. She stayed in bed all day on Tuesday. Patient was asking what will happen if she does not take the second vaccine. The same morning while she was waiting to get the vaccine, a co-worker sent her a video of a woman who had received a COVID vaccine. She does not know which one. The woman experienced Bell's Palsy. The woman was crying and her face was turning side ways. She stated some people were talking negatively about the vaccine. She stated doesn't want her face to be deformed. She stated what are the cons of not taking the second vaccine. Reporter assessed the events as non-serious. Outcome of the events some memory loss and locked jaw/unable to open mouth was recovered on 30Dec2020, outcome of the events excruciating pain on her left ear, pain went in her jaws, her arm was hurt was recovering. Outcome of swelling in arm and she was really scared was unknown.
62 2021-01-12 anaphylactic reaction, lymph node swelling 1st 24 hrs just arm soreness, 2nd 24 hrs itching and fatigue, 48 hrs, anaphylaxis, hives, rash, itch... Read more
1st 24 hrs just arm soreness, 2nd 24 hrs itching and fatigue, 48 hrs, anaphylaxis, hives, rash, itching, lymph swelling, chills
62 2021-01-14 swollen extremities body aches, chills, cough, headache, nausea--soreness/swelling left armpit
62 2021-01-14 peripheral swelling Body aches, chills, cough, headache, nausea, soreness and swelling of L arm pit.
62 2021-01-17 swelling Swelling, itching, in the throat. One hive
62 2021-01-18 lymph node swelling Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling ... Read more
Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob. Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.
62 2021-01-18 peripheral swelling Once i received the 2nd dose- My arm swollen for 3 days - continue to be red as thought rash going... Read more
Once i received the 2nd dose- My arm swollen for 3 days - continue to be red as thought rash going over the top half of arm around the injected area. chills , body aches, fever. stayed in bed the next 3 days. 4 day sweating, and low grade fever , fatigue very weak.
62 2021-01-19 lymph node swelling Headache, dizziness, swollen glands chin/throat sore throat and chills. Extreme fatigue. Covid tes... Read more
Headache, dizziness, swollen glands chin/throat sore throat and chills. Extreme fatigue. Covid test and ruled out.
62 2021-01-19 swollen extremities Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling ... Read more
Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob. Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.
62 2021-01-20 lymph node swelling cervical lymphadenopathy, started 1 day after vaccine administration
62 2021-01-20 peripheral swelling tongue itching; lips itching; face feels flushed; left hand is tingling or numb (the palm)/left hand... Read more
tongue itching; lips itching; face feels flushed; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; palm of left hand was itchy; inside of nose; it feels like someone is pinching nose/It's swelling; inside of nose; it feels like someone is pinching nose/It's swelling; face has a rashly feeling; This is a spontaneous report from a contactable consumer reported for self. This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on an unspecified date at single dose in left arm for COVID-19 immunisation. The patient medical history and concomitant mediations not provided. The patient reported that she had the vaccine at her work, waited 15 minutes and left the clinic. About 20 minutes then, her tongue was itching, lips were itching; face felt flushed. Face had a rashly feeling. Her left hand was tingling or numb (the palm). Her palm of left hand was tingling and itchy. The inside of nose; it feels like someone is pinching nose. It was swelling. The patient stated "Whenever I get stung by bees, this is how I feel". The patient stated that it was mild. She stated she was having a reaction, but not severe enough maybe it will subside. Her left arm is where she got the injection and it was left hand that was puffy and tingling. The patient stated that she also had N95 mask on and she guess she get that reaction from it. The patient stated that she was just wondering what she should do, if she should just go by some diphenhydramine hydrochloride (BENADRYL). The outcome of events was not reported. Information about lot/batch number has been requested.
62 2021-01-21 swelling Patient was given the Pfizer vaccine at 9:27 on 01/21/21. At about 5 minutes post vaccine she was n... Read more
Patient was given the Pfizer vaccine at 9:27 on 01/21/21. At about 5 minutes post vaccine she was noted to have some throat clearing but denied any concerning symptoms. At 9:40 she began experiencing fluttering in her chest and at 9:41 she was noted to have some chest tightness and wheezing. She was given Benadryl 50 mg oral at 9:42 but then symptoms began to progress and she started to have angioedema of her upper lip and her hands/arms started itching and she was noted to have some early hives. Epipen 0.3 mg was given at 9:45. She continued to have some swelling of her upper lip and chest tightness and soulmedrol 125 mg IM was given at 9:49 and then she was placed on O2 via NC at 2 L. At 9:50 she stated that her throat swelling was starting to improve and her chest tightness and wheezing was getting better. EMS arrived at about 9:51 and report was given and care turned over to them. They left the clinic at 10:00 without further incident.
62 2021-01-24 lymph node swelling Within 10 min after injection had pain in left side of neck and jaw. was given 800mg Ibuprofen and t... Read more
Within 10 min after injection had pain in left side of neck and jaw. was given 800mg Ibuprofen and took for a few days. On Jan 6, 2021 supraclavicular swelling occurred near base of neck size of a baseball and lt neck pain. Saw physician on 1/8/21 and have soft tissue swelling
62 2021-01-24 swelling Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; ... Read more
Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; Swelling; This is a spontaneous report from a contactable nurse (patient). A 62-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 08Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included ibuprofen and paracetamol (TYLENOL). 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 previously took first dose of bnt162b2 (lot number: Ek5730, expiry date not reported) in the right arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 08Jan2021 at 18:00, the patient experienced brain fog, headache, muscle spasm at injection site, severe fatigue, joint pain, driving difficult and swelling. It was unknown if treatment was received for the adverse events. Clinical outcome of the events was not recovered.
62 2021-01-25 lymph node pain, lymph node swelling runny nose; slight cough; Lethargy; very tired; no appetite; Severe body aches; chills; fever; my ly... Read more
runny nose; slight cough; Lethargy; very tired; no appetite; Severe body aches; chills; fever; my lymph nodes under my injection arm became swollen and sore; my lymph nodes under my injection arm became swollen and sore; This is a spontaneous report from a contactable other HCP (patient). A 62-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: 0140) intramuscular in right arm on 11Jan2021 15:30 at single dose for COVID-19 immunization. She received the first dose of BNT162B2 (lot number: 0140) intramuscular in left arm on 21Dec2020 16:15 for COVID-19 immunization. Medical history included Sulfa and PCN allergy. There was no other medical history. There was no concomitant medications. There were no other medications in two weeks, no other vaccine in four weeks. The patient experienced severe body aches, chills, and fever starting approximately 8-10 hours after vaccine on 11Jan2021. These symptoms were accompanied by a runny nose and slight cough on 12Jan2021 08:00. Lethargy, very tired, no appetite also on 12Jan2021 08:00. Symptoms resolved with Tylenol, Nyquil, and one day of deep sleep. On the second day (Jan2021), her lymph nodes under her injection arm became swollen and sore. Patient is not pregnant. Events were recovered on Jan2021.
62 2021-01-25 lymph node swelling Left axillary lymphadenopathy with pain
62 2021-01-25 swollen extremities Patient self-reported to the hospital's electronic ADR reporting system. In her own word, "After 2... Read more
Patient self-reported to the hospital's electronic ADR reporting system. In her own word, "After 2nd dose of Pfizer COVID-19 Vaccine 1/15/21, the injection site became swollen , itchy, and painful. The following day, under my armpit was swollen and painful. This lasted for 5 days".
62 2021-01-26 lymph node swelling Woke up at 5am 1/26/21 with Headache, body aches, ax temp 100.4. Left arm pain with enlarged lymph ... Read more
Woke up at 5am 1/26/21 with Headache, body aches, ax temp 100.4. Left arm pain with enlarged lymph nodes left axillary area. Fatigued. Headache became debilitating around noon. Extra strength Tylenol decreased temperature and body aches but did not help with headache. Fatigued all day. 1/27/21 10amFatigued, headache, body aches gone.
62 2021-01-27 fluid retention Vaccine given high up on shoulder, not 3 finger widths down. Persistent pain right shoulder and uppe... Read more
Vaccine given high up on shoulder, not 3 finger widths down. Persistent pain right shoulder and upper arm, positional discomfort. Pocket of fluid accumulation above right clavicle.
62 2021-01-27 fluid retention Persistent shoulder and upper arm discomfort. Positional discomfort, pocket of fluid above right cla... Read more
Persistent shoulder and upper arm discomfort. Positional discomfort, pocket of fluid above right clavicle. I believe injection was given improperly, too high up on shoulder, not 3 finger widths down.
62 2021-01-27 swelling approx. 15-20 min after vaccine admin, pt c/o "ha, fatigue", evaluation by EMT, vs 158/86 100, spo2 ... Read more
approx. 15-20 min after vaccine admin, pt c/o "ha, fatigue", evaluation by EMT, vs 158/86 100, spo2 97, p=101, pt reports that this bp is "normal for her", she remained alert aned oriented, progressed to feeling "flushed from head to waist", at 5:05 pm, pt feels that these s/s r/t "very busy all day,this is the first time I have sat down all day", bp 168/95, 103, spo2 96, cool pack applied to back of neck, pt reports increase in feeling , "flushed", 1720- pt c/o "my neck feels swollen, my jaw hurts", denies shortness of breath, or chest pain, no hives observed on head, or abd, pt agrees to more advanced eval at ER, husband notified, 1730, pt experiences dry heaves, no emesis, bp 179/109, Ambulance called to transport to ER, IV initiated by EMT, 1740, pt to stretcher, with ambulance crew, report given, pt continues to deny shortness of breath, and chest pain, she remains alert and oriented.
62 2021-01-31 anaphylactic reaction Systemic: Anaphylaxis-Severe, Systemic: Exhaustion, Systemic: Nausea
62 2021-01-31 lymph node swelling, lymph node pain behind my ear I feel like it's like the gland is swollen; behind my ear I feel like it's like the gl... Read more
behind my ear I feel like it's like the gland is swollen; behind my ear I feel like it's like the gland is swollen/saw the swelling and it's painful, pain a little bit, painful; This is a spontaneous report from a contactable consumer (reported for herself). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration in the left arm on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she had the first dose of vaccine and it was on Tuesday afternoon (12Jan2021) and this morning (16Jan2021), she woke up and felt behind her ear, she felt like it's like the gland was swollen, so she wanted to know if anything to concern about it or she should wait few days or asked if is this normal for the gland could be swollen from an infection but. The further stated she didn't take anything as treatment but stated, its just this morning she woke up and she saw the swelling and its painful, pain a little bit, painful. The outcome of the events was unknown. Information on Lot/Batch number has been requested.
62 2021-02-01 lymph node swelling Caller states she received her 2nd dose of covid vaccine on Friday afternoon. Saturday morning she s... Read more
Caller states she received her 2nd dose of covid vaccine on Friday afternoon. Saturday morning she started with Left arm redness, swelling and soreness. Today the redness and swelling measures about 4x6. She also reports noticing a swollen lymph node to her left arm today. She denies fever. She has been taking tylenol and motrin, but has not tried compresses to injection site. She will call her PCP to schedule an appointment for tomorrow.
62 2021-02-01 swelling face fever and facial swelling
62 2021-02-02 swelling Headache, NauseaVomiting, Muscle aches ,swelling right side of neck, fatigue, night sweats, fever,. ... Read more
Headache, NauseaVomiting, Muscle aches ,swelling right side of neck, fatigue, night sweats, fever,. Narrative:
62 2021-02-07 lymph node swelling Headache, Fever chills times four days, mouth sores, swollen lymph nodes, joint pain, fatigue.
62 2021-02-12 lymph node swelling, lymph node pain The day of the shot, I was fine. But I went to bed at about 10:00 that night and slept very little... Read more
The day of the shot, I was fine. But I went to bed at about 10:00 that night and slept very little. I was chilling so badly that I couldn't get to sleep! When I got out of bed in the morning, I could barely move due to severe muscle pain. I did very little all day, suffering from what felt like the flu: chills, loss of appetite, and "brain fog" such that I couldn't read or think clearly. My head felt warm, but I never took my temperature. The next morning, I noticed hives on my chest between my breasts and around the armpit of my left arm. The following morning, now about 45 hours after my second injection, I still had pink hives, and my left armpit was swollen so that it wasn't concave, as it always is, but convex. Touching my armpit hurt, and I think some gland in it was swollen. Similarly, a gland on the left side of my neck was swollen and painful to the touch. Today, now the fourth day since the injection, the hives have subsided, and my glands are almost back to normal. Overall, I am very glad to have had the opportunity to get the vaccine, but I haven't felt that sick in years.
62 2021-02-13 lymph node pain, lymph node swelling Tender and swollen left axilla (probably lymphadenopathy) for 3-4 days. Resolved without treatment.
62 2021-02-16 peripheral swelling Swollen lt. arm, severe body aches and pain, headache, excessive sweating for 14 hrs. Missed work o... Read more
Swollen lt. arm, severe body aches and pain, headache, excessive sweating for 14 hrs. Missed work on 1/27/2021. 8 hrs.
62 2021-02-17 lymph node swelling Swollen lymph nodes in left armpit, some injection site soreness. Lymph node swelling occurred appr... Read more
Swollen lymph nodes in left armpit, some injection site soreness. Lymph node swelling occurred approx 1 day after vaccine
62 2021-02-19 lymph node swelling Greatly enlarged axillary lymph node. Fever. Body aches. Headache. Augmentin
62 2021-02-19 swollen extremities, lymph node swelling Felt severe muscle pain and aches the next day starting about 2:00 pm . Went to bed about 6:30 that ... Read more
Felt severe muscle pain and aches the next day starting about 2:00 pm . Went to bed about 6:30 that night. Woke up in the middle of night and I could tell I had a "huge lump" in my Lt armpit. The lump is very sore. No redness or hot to touch. I am going to watch it over the next few days. If it gets bigger or red, I will seek medical advise. I am guessing it is a inflammatory reaction to the vaccine and my lymph nodes are inflamed there. No other lymph nodes are swollen any where else.
62 2021-02-19 peripheral swelling Hives on torso on day of vaccination (Thursday), Friday, hives on upper left arm (3? diameter) in th... Read more
Hives on torso on day of vaccination (Thursday), Friday, hives on upper left arm (3? diameter) in the evening . Saturday afternoon, both upper arms with the same dimension. Sunday afternoon,torso, both hands, palms , fingers (swelling), wrists. Monday afternoon, front torso. Tuesday afternoon, both wrists, upper right arm. Wednesday afternoon, full length of left arm and upper right arm, both palms. Thursday morning, both palms, left for arm. Thursday afternoon, torso. Friday late evening, torso. Started cortisone cream on Friday, Benadryl on Saturday, switched to Allegra on Thursday.
62 2021-02-21 anaphylactic reaction The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teet... Read more
The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; pain in neck; pain in left shoulder; The shortness of breath lasted over; My lips were tingly; I could feel the end of my nose. My throat was closing/throat closing a little bit; I had pain in my arm; my muscles ached.; The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; anaphylaxis; allergic reaction to the first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN5318), via an unspecified route of administration on 22Jan2021 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included drug allergies from an unknown date. There were no concomitant medications. The patient experienced anaphylaxis on an unspecified date in 2021. The patient had a little bit of an allergic reaction to the first dose of the Pfizer COVID 19 vaccine in 2021, it was not severe enough to use an Epipen. The shortness of breath from 22Jan2021 18:00 lasted over a week. Her lips were tingly from 22Jan2021 14:30, she could feel the end of her nose. Her throat was closing from 22Jan2021 14:30. She had pain in her arm from 22Jan2021 11:00, and her muscles ached from an unspecified date in 2021, the left side of her face, ear, throat and teeth hurt (facial pain from an unspecified date in 2021, ear pain from 22Jan2021 23:00, throat pain from an unspecified date in 2021, tooth pain from 22Jan2021 23:00), pain in left shoulder from 22Jan2021 20:30, pain in neck from 22Jan2021 23:00. She did have to take Benadryl for treatment of shortness of breath. She felt better after 1.5 weeks. The outcome of events anaphylaxis, allergic reaction, muscles ached, Facial pain, Throat pain was unknown, outcome of event pain in arm was resolving, outcome of event tooth pain was resolved on 23Jan2021, outcome of shortness of breath was resolved on 01Feb2021, outcome of other events was resolved on 24Jan2021.
62 2021-02-21 peripheral swelling, swelling face 01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Calle... Read more
01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Called dr and had a Telemed call with NP on Tues. 01/26. Predisone and Benadryl was prescribed. Thurs. 01/28 Call to let them know that it wasn?t working. I went into the office for one shot of Solumedrol. This help and they were gone. They gave me second dose of Predisone to take in case it came back and to continue the Benadryl. 02/8 Second vaccine. Hives began that night: arms, torso, thighs, hair. Call the Dr. on 02/10 and suggested I go to an allergist. Went to allergist on 02/11 she said to only take one Predisone, Allegra one am and one at noon, then take zertek at nighttime. The Predisone created a major brain fog, I had to stop. Saw the allergist on 2/18, she agreed to get off the Predisone. 02/11 I passed out in the am and when I woke up with vomit running down my face. Still suffering with hives this entire time. 02/17 my face, lips, tongue started to swell and I had chest pain for 90 minutes. My feel swelled and I have hives so bad on my feet I could not walk or put on shoes. 02/20 Woke up with sweat on my chest. My hands were so swollen I had to have my wedding ring was cut off . 02/21 I went to the Urgent Care and received a shot of Solumedrol. They said this should last me for a few days. 02/21 woke up 3 time throughout the night soaked in sweat.
62 2021-02-24 swelling bulging on her side; pain/It hurts; symptoms of acute pancreatitis; This is a spontaneous report fro... Read more
bulging on her side; pain/It hurts; symptoms of acute pancreatitis; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Feb2021 at single dose in left arm for COVID-19 immunisation at the age of 62-year-old. Lot number was EN3318, expiration date 31Mar2021. Relevant medical history and concurrent conditions included ongoing Primary immunodeficiency syndrome, ongoing lupus, ongoing Type 2 diabetes since 2001, sleep disorder. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date at single dose for COVID-19 immunisation (lot number was lot number EJ1686 or EJL1686). Past drug history included HIZENTRA for Immune system disorder (for years). Concomitant medications included ongoing sitagliptin phosphate (JANUVIA) for Type 2 diabetes, ciprofloxacin, trazodone and alprazolam for sleep disorder, methocarbamol as muscle relaxant. On 06Feb2021, the patient experienced symptoms of acute pancreatitis. The patient has spoken to a Doctor and a Nurse practitioner. The patient refused to go to the hospital. She was drinking an incredible amount of fluids, and she was taking stuff for pain. The patient took Tramadol too, but it did not do anything; it did not ease any pain; she did not seem to respond to it. The patient was bulging on her side, it hurt. The patient did not recover from acute pancreatitis, the outcome of other events was unknown.
62 2021-02-26 peripheral swelling high heart rate, muscle aches and pains, left arm still hurts, still swollen in areas. My arm flet ... Read more
high heart rate, muscle aches and pains, left arm still hurts, still swollen in areas. My arm flet like it had a fever at injection sight. I was pale in face.
62 2021-02-27 lymph node swelling Experiencing swollen, very tender lymph nodes under armpit. Taking Tylenol for pain. Symptoms are g... Read more
Experiencing swollen, very tender lymph nodes under armpit. Taking Tylenol for pain. Symptoms are getting better.
62 2021-02-28 peripheral swelling Moderate swelling of upper thighs. First right leg then both legs.
62 2021-02-28 swelling face Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoar... Read more
Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoarseness, severe fatigue, headache, brain fog for first 20 hrs, then intermittent eyelid and face swelling, hoarseness, fatigue and brain fog for the next 3 days, followed by mast cell activation symptoms of fatigue, puritis, and mild racing heart in the evening for the last two days. For the past 3 years I have been medication free and virtually symptom free. The symptoms of the last few days are consistent with those I had during the years when my MCAD was active. I am concerned that the vaccine has reactivated the hyper-sensitivity of my mast cells.
62 2021-03-02 lymph node swelling One day after vaccine severe body aches and sore arm. I had covid 19 in October 2020 and found the b... Read more
One day after vaccine severe body aches and sore arm. I had covid 19 in October 2020 and found the body aches after the vaccine to be worse than having the virus itself. Second day after vaccine I noticed lymph node in my armpit to be very swollen. This was the same side of my body the shot was given. I am worried about getting the second dose but I am still going to get it.
62 2021-03-04 lymph node swelling Rash, itching, swollen lymph nodes under right arm
62 2021-03-04 swelling I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day... Read more
I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day 10 after the vaccine and my mast cell reactivity symptoms have increased by the day--internal and external swelling, flushing, pruritis, wheezing, tightness in chest, as well as pain and pressure in arm pits, groin, and ears. By late afternoon I am severely fatigued, weak, and foggy-headed. These symptoms are consistent with those I experienced during the twenty years when my mast cell disease was unstable. Through identification of my triggers and avoidance of the same, I have been symptom and medication free for the past three years--until taking the Covid-19 vaccine. It appears that the vaccine has reactivated an excessive degranulation response in my mast cells and that response is getting worse as my body responds to the vaccine. I realize that the percentage of persons who suffer from a condition like mine is small, but I would have appreciated having the information that I am submitting to you when I was weighing the pros and cons of vaccination. I know from the twenty years of navigating this disease that there is nothing that can be done at this point other than taking various H1 and H2 blockers. This vaccine appears to be undoing the hard-won level of stability achieved through years of careful lifestyle management.
62 2021-03-08 lymph node pain Within minutes after receiving shot I became completely dizzy, lightheaded and started to faint. EMT... Read more
Within minutes after receiving shot I became completely dizzy, lightheaded and started to faint. EMT came to my aid and took vitals all looked OK. I stayed in place until I felt better about 30 minutes. For the rest of that day and the next day I was extremely tired, a little nauseous, and kind of out of it. The third day I had very sore left arm at site and very sore and tender lymph notes on left side of Arm and trunk. Six days after the shot I came suddenly down with a massive headache and diarrhea. Al has since resolved and I am on day eight.
62 2021-03-08 peripheral swelling My left upper arm was red, swollen, knotted for 9 days after my 1sf shot. The knot and swelling has ... Read more
My left upper arm was red, swollen, knotted for 9 days after my 1sf shot. The knot and swelling has subsided but the area is still red and itching.
62 2021-03-09 swelling face Very prominent swelling of the lips and right side of face
62 2021-03-09 swelling 2nd dose of the COVID-vaccine administered on the morning of 2/18/21. Within the hour after adminis... Read more
2nd dose of the COVID-vaccine administered on the morning of 2/18/21. Within the hour after administration, severe pain on left shoulder (site of administration) was experienced. Swelling, consistent aching pain, and limited range of motion/inability to lift arm over her head. Motrin for 2 days was self administered with improvement in severity of pain but recurred when Motrin discontinued. Motrin was taken as needed thereafter and was the pain continued until 2/26. Employee was followed up on 3/10 and verbalized that the pain had fully resolved. No further interventions.
62 2021-03-10 lymph node swelling, lymph node pain Fever (101) Swelling, pain under arm that was vaccinated, lymph nodes Body chills Headache
62 2021-03-10 swelling face After 1 hour facial swelling; After 45 minutes cheeks red; After 30 minutes face felt very hot; Stro... Read more
After 1 hour facial swelling; After 45 minutes cheeks red; After 30 minutes face felt very hot; Stronger pain at injection site than with yearly flu shot; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old female patient (who was not pregnant at time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 25Jan2021 13:15, as single dose for COVID-19 immunization, at hospital. Medical history included Allergy to All pain relievers and anti-inflammatory drugs and over the counter, allergies to penicillin and Allergies to sulfites all types. Patient was not allergic to Keflex injections, but allergic to the pull form. Concomitant medications included amlodipine, fluticasone propionate (FLONASE), famotidine (PEPCID AC), calcium, colecalciferol (CALCIUM/VIT D) and one a day multi vitamin (within 2 weeks of vaccination). Patient previously took cefalexin (KEFLEX), Bacitracin, Neomycin, Lidocaine, Prednisone; had allergies with these all medications. Historical vaccine included influenza vaccine (FLU SHOT) and had Pain at injection site. 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. Since the vaccination, patient has not been tested for COVID-19. After 30 minutes of vaccine, face felt very hot. After 45 minutes cheeks red. After 1-hour facial swelling. Took 1 Benadryl tablet after noticing swelling. Heat and redness then faded. Facial swelling reduced over the next 24 hours without more Benadryl. Stronger pain at injection site than with yearly flu shot, for which patient was not received treatment. Seriousness of the events was reported as non serious. Outcome of the events was recovered in Jan2021. Information on the lot/batch number has been requested.
62 2021-03-10 swelling At time of injection, severe burning, bruising, and then a very large swelling/lump, redness/rash, a... Read more
At time of injection, severe burning, bruising, and then a very large swelling/lump, redness/rash, and pain. At three days post vaccine now and redness/rash almost gone, swelling some diminished but still very present, pain some diminished but still present, and bruising still present.
62 2021-03-11 lymph node swelling Exactly 12 hrs after second injection I had 103 temperature, severe shakes and chills. Both knees an... Read more
Exactly 12 hrs after second injection I had 103 temperature, severe shakes and chills. Both knees and arms at the elbows swelled and the elbow and Lymph nodes on my right inner elbow are still swollen. I am just now able to grip anything with my Left hand. I had both vaccines in my right arm. I am predominantly left handed. This has affected my work asin which I am still working full time.
62 2021-03-11 peripheral swelling Right hand swelling with no numbness or tingling. Looked in no acute distress. Observed for 30 min... Read more
Right hand swelling with no numbness or tingling. Looked in no acute distress. Observed for 30 minutes and discharged home in a stable condition.
62 2021-03-11 swelling face Patient has allergies to several medications and keeps epipen on hand with her always. Was asked to ... Read more
Patient has allergies to several medications and keeps epipen on hand with her always. Was asked to sit for 30 minutes after vaccine. At minute 27 she started getting swelling and redness of her lips and face slightly. She normally takes Benadryl when this happens so gave her a Benadryl 50mg one dose. Her throat then became tight in a few minutes and she said that she needed an epipen because she was starting to have a little bit of trouble breathing. Gave epipen and her symptoms resolved within a few minutes. Kept her for 15 minutes. She stated that she knew she would be ok and asked if she could leave. I stated she needed to see the ER if she had any more trouble. I also consulted with her to check with her doctor about getting the 2nd dose because more than likely it's not recommended.
62 2021-03-13 lymph node swelling Headache first 30 min, malaise 6-7 hrs after , joints shoulders and hands/fingers x48 hrs moderate /... Read more
Headache first 30 min, malaise 6-7 hrs after , joints shoulders and hands/fingers x48 hrs moderate /severe then lessening, Swollen Armpit lymph node 3 in x 4 in for 48 hrs then getting smaller . Severe to moderate pain . Congested all days , needed Inhaler first 24 hrs , benedryl and decongestant , naproxen and Tylenol needed all days