Pfizer

Skin & localized to injection site symptom reports

Female, 60 - 75 years

Age Reported Symptoms Notes
60 2020-12-31 itchy rash, rash Patient was discharged at 1:25 came back at 1:36 with itchy rash on forearm, given Benadryl 50mg IM.... Read more
Patient was discharged at 1:25 came back at 1:36 with itchy rash on forearm, given Benadryl 50mg IM. Assessed by doctor working clinic at 2:15, rash was fading and itching resolved. No breathing or airway issues, was discharged.
60 2020-12-31 rash I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Ligh... Read more
I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Lightheaded , some dizziness that night. Forced the water intake. 12-30-2020, went to work, as the day went on the rash on my face and neck into upper chest increased and Hypertension. I went to the ER Dept at Hospital. IV Fluids and IV Benadryl and oral Prednisone and Prednisone to be taken at home. Face and neck rash goes away and comes back as of Jan 1 2021.
60 2021-01-02 injection site pain No symptoms or pain with initial injection. I came home about 2 hours after the injection and took ... Read more
No symptoms or pain with initial injection. I came home about 2 hours after the injection and took one 200mg ibuprofen and one 500mg acetaminophen and put an ice pack on the site briefly. Later that afternoon I developed pain at the injection site that progressively got worse over the course of the evening so bad that I could not raise my left arm of touch the site. I put an ice pack on again and that night I slept with a heating pad on. I would rate the pain 8/10. When I woke the next day the pain was still there, but not as severe. I got in the shower and let the hot water beat on the injection site and that seems to help a lot. The pain gradually lessened over the course of the day to a 2/10. By the following day (3rd day post injection) the pain had completely subsided. There was no redness or swelling at the site and I did not have any other symptoms other than the intense injection site pain.
60 2021-01-03 injection site pain * Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, ... Read more
* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, cold and unable to get warm even with multiple blankets * Severe dizziness and vomiting * Headache not relieved by Ibuprofen; took 25 mg Benadryl at midnight
60 2021-01-03 rash, redness 12/18/20 08:00PM Mild headache; 12/19/20 headache resolved; chills, loose bowel movement, fatigue. ... Read more
12/18/20 08:00PM Mild headache; 12/19/20 headache resolved; chills, loose bowel movement, fatigue. 12/20/20 loose bowel movement, rash on back and disappeared face red lips swollen. 12/21/20 symptoms continued medications taken Benadryl. Imodium; rash resolved and loose bowel movements later in the day. Abd discomfort, pain and nausea present since vaccine given.
60 2021-01-03 hives Hives
60 2021-01-04 redness, itchy rash, rash Red, itchy rash to both upper and lower extremities and upper back. Started 1/01/2021 to present. T... Read more
Red, itchy rash to both upper and lower extremities and upper back. Started 1/01/2021 to present. Treated with prednisone 60 mg x 5 days and trimcinolon 0.025% topically
60 2021-01-04 injection site swelling, injection site hardening, injection site bruising Immediately after injection into patient's left deltoid, site swelling and felt firm. Some bruising... Read more
Immediately after injection into patient's left deltoid, site swelling and felt firm. Some bruising noted. Ice applied and patient monitored for over 30 minutes. Patient did complain of scratchy throat while being monitored, but refused Benadryl at this time. Patient will notify her physician of this reaction to the vaccine.
60 2021-01-04 injection site swelling, injection site pain Injection site pain and swelling the day after vaccination
60 2021-01-04 rash, itchy rash, rash with redness Red, itchy rash to upper back, both upper and lower extremities.
60 2021-01-04 vaccination site pain Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a... Read more
Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a non-contactable other-HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231) (Brand= Pfizer), via an unspecified route of administration on 24Dec2020 07:15AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was workplace clinic. None medical history. The patient's concomitant medications was not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies included Ibuprofen based pain medicine. On 24Dec2020, patient experienced injection site pain; chills; facial flushing. 25Dec2020 fever. 26Dec2020 rhinorrhea. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. No follow-up attempts are possible. No further information is expected.
60 2021-01-04 vaccination site rash, eczema, itchy skin 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 redness 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 itchy skin, injection site redness INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINES... Read more
INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINESS, TIREDNESS, MUSCLE PAIN, CHILLS ALL BY 13:30PM AND LASTED FROM 1.04.21 AND CURRENTLY ON 1.06.21 STILL TIRED, DIZZY, HEADACHE, CHILLS AND ITCHY BUT IS BETTER THAN ON 1.04.21.
60 2021-01-05 itchy skin Itching but no hives; dizziness; slight headache; This is a spontaneous report from a contactable nu... Read more
Itching but no hives; dizziness; slight headache; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received first dose of BNT162B2 (Batch/lot number: EK5730) intramuscular at Left arm, on 31Dec2020 at single dose for covid-19 immunisation. Medical history included mild Hypertension (HTN), Hypothyroidism, Anxiety, Gastrooesophageal reflux disease (GERD), Hyperlipidemia. Known allergies included Shellfish, SSRI, Demerol, Codeine. The patient did not have covid prior vaccination. Patient had no other vaccine in four weeks. Concomitant medication included lisinopril, levothyroxine, aluminium hydroxide gel, dried, magnesium carbonate (PEPCID), bupropion hydrochloride (WELLBUTRIN), atorvastatin calcium (LIPITOR), acetylsalicylic acid (BABY ASPIRIN), vitamin c [ascorbic acid], calcium, linum usitatissimum seed oil (FLAX SEED OIL), glucosamine, curcuma longa (TURMERIC), ubidecarenone (COQ 10), collagen. The patient experienced itching but no hives, slight headache, dizziness on 31Dec2020 15:30. The patient received Benadryl 25mg for the events. The patient did not have covid tested post vaccination. The outcome of events was recovering.
60 2021-01-05 itchy skin 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 2021-01-05 rash macular BLOTCHES OVER ENTIRE BODY NO OTHER SYMPTOMS. TREATED WITH BENADRLY OBSRVED 30 MIN AND RASH RESOLVED
60 2021-01-05 vaccination site swelling, vaccination site redness, vaccination site itchiness Golf ball size swelling below the injection site. Arm is red and itchy; Golf ball size swelling belo... Read more
Golf ball size swelling below the injection site. Arm is red and itchy; Golf ball size swelling below the injection site. Arm is red and itchy; Golf ball size swelling below the injection site. Arm is red and itchy; This is a spontaneous report from a contactable other-HCP (patient). This 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 28Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included pulmonary embolism and known allergies: penicillin. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), vitamin b complex (VITAMIN B), ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), tocopherol (VITAMIN E), received within 2 weeks of vaccination. Facility that the most recent COVID-19 vaccine administered was in Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 14:45, the patient experienced golf ball size swelling below the injection site. Arm was red and itchy. No treatment received for the adverse event. Outcome of the events was recovering. This report was assessed as non-serious. Information about Lot/batch number has been requested.
60 2021-01-06 injection site pain, redness 30-40 min felt flush skin on body face bright red. Numbness tingling in hands and feet. Took some a... Read more
30-40 min felt flush skin on body face bright red. Numbness tingling in hands and feet. Took some advil. Over next two days on and off hot flashes tingling numbness on hands and feet. Very cold feet couldn't get warmed up till wrapped up on heating pad. Ño fever but felt chills. Sore arm site of injection.
60 2021-01-06 injection site pain APPROXIMATELY 24 HOURS AFTER THE INJECTIONS I RAN A FEVER OF 100.7, BODY ACHES OVER ALL JOINTS, EXT... Read more
APPROXIMATELY 24 HOURS AFTER THE INJECTIONS I RAN A FEVER OF 100.7, BODY ACHES OVER ALL JOINTS, EXTREME FATIGUE AND HEADACHE ADN THE INJECTION SITE WAS PAINFUL. I HAD THE COVID VIRUS DIAGNOSED 10/23/2020 WITH THE EXACT SAME SYMPTOMS EXCEPT I RAN A HIGHER TEMP
60 2021-01-06 injection site pain Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. wit... Read more
Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. without any issues. Came home, had 2 glasses of wine, as usual, at 1:00 a.m. feeling body aches and headache continued sleeping, woke up at 9:00 a.m. with dry heaves with phlegm with small streaks of blood, rapid heart rate, fatigue with body aches, pain in location of injection, occasional headache, loss of appetite. The body aches, fatigue continued the following day, appetite returned slightly. Thankful these were my scheduled days off from work. Third day after injection body aches dissipating able to go out of the house to do errands.
60 2021-01-06 injection site swelling Single raised bump at inject site - no redness or pain
60 2021-01-06 skin hardening, skin irritation, redness, itchy rash intensely pruritic rash, starting around neck initially and then presenting in perianal area, moving... Read more
intensely pruritic rash, starting around neck initially and then presenting in perianal area, moving up lower back with sharp linear demarcations, also perinasal bilat . Also on eyelid with periorbital edema rt>lt. Typical appearance of contact derm with raised indurated intensely pruritic lesion except almost exact opposite in distribution (flexoral/internal aspects of skin) and no known exposures. Now day two and rash is becoming more well demarcated, more red and inflamed and spreading in distribution face, neck and lower back. There is no logical explanation for this rash.
60 2021-01-07 itchy rash, rash arm was sore; she has like underneath her neck, underneath her armpits, underneath her breast, on he... Read more
arm was sore; she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach; inherited some type of reaction like a rash, its itchy; 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: EJ1685, Expiry Date: Mar2021, via an unspecified route of administration on left arm from 29Dec2020 to 29Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, Hypertension (verbatim: Blood Pressure High), thyroid disorder (verbatim: Thyroid), cholesterol. The patient's concomitant medications were not reported. The patient stated she got her vaccination on 29Dec2020, that's Tuesday and her arm was sore the next day (30Dec2020) but she have inherited some type of reaction like a rash, its itchy, her hands are itching like crazy, she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach that's not so itchy it's the hands that's itchy. The patient was asking what should she do. The outcome of the events was unknown. When asked for treatment for the events, the patient stated, "I was doing some, I take an Aleve, Aspirin and then I was taking some Benadryl capsule for allergy."
60 2021-01-07 hives, rash chills; fatigue; small rash on left arm (size of half dollar); 1 pinpoint spot "hive": under chin, o... Read more
chills; fatigue; small rash on left arm (size of half dollar); 1 pinpoint spot "hive": under chin, on right arm, under left foot; This is a spontaneous report from a contactable nurse (patient). A 60-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284), via intramuscular route of administration in the right arm on 28Dec2020 at 05:30 AM (at the age of 60 years-old) as a single dose for COVID-19 vaccination. Medical history included diabetic and asthma. The patient's allergies included sulfa, iodine, shellfish and latex/rubber. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were other medications the patient received within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 28Dec2020 at 06:30 AM, the patient experienced chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The report was reported as non-serious. The patient was not treated for chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The clinical outcome of chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
60 2021-01-07 vaccination site pain, vaccination site redness, vaccination site mass very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt real... Read more
very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt really really sick/ didn't feel good/felt very bad; Sweating; Nauseous; loose stool; her injection site had a lump and was red; a little pain in her arm/ it was just a little sore; her injection site had a lump and was red; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 11:30 at single dose in the arm for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient received the vaccine 29Dec2020 at 11:30 am. She went to work at 11 at night and only had a little pain in her arm. At 4 am on 30Dec2020, she felt really sick. She felt like her blood pressure dropped. She was very dizzy. She was scared. She didn't feel good. She felt like she was going to faint and was sweating. She was going to try to finish her work and go home. She went to the house, and was very sick. She got into bed because she believed she needed rest. At 3 pm on 30Dec2020, nothing was wrong. She was going to rest more. That night time on 30Dec2020, she felt better. She had also got nauseous. She stated the symptoms only lasted a day, and also said the side effects only lasted from 4 o'clock to 8 o'clock when she got home. She did go to the bathroom and experienced loose stool. She felt very bad when she laid down in bed. By 10 o'clock pm (30Dec2020) she felt better. The patient said she had no problem moving her arm as it was just a little sore. When she got home from work her husband noticed her injection site had a lump and was red. Her arm recovered in a week's time. The patient stated she would go for her second shot on 13Jan2021. The symptoms which started on 30Dec2020 04:00 (dizzy/felt like her blood pressure dropped/she felt like she was going to faint, feeling sick/bad, sweating, nauseous, loose stool) were resolved on 30Dec2020. The events pain in her arm and injection site lump and red were resolved on an unspecified date in Jan2021. Information about lot and batch number was requested.
60 2021-01-07 vaccination site swelling Sudden onset nausea; Swelling at injection site.; abdominal cramps; single episode loose stool; This... Read more
Sudden onset nausea; Swelling at injection site.; abdominal cramps; single episode loose stool; This is a spontaneous report from a contactable nurse, the patient. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140), via an unspecified route of administration on 30Dec2020 at 09:15 (at the age of 60-years-old) as a single dose, in the right arm for COVID-19 vaccination. Medical history included lymphedema, lipedema, depression, osteoporosis, osteoarthritis, hypothyroid, malabsortion with vitamin deficiencies, anemia, and allergy to latex. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, however it was reported the patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took thimerisol and influenza vaccine both from unknown dates to unknown dates for unknown indications and experienced allergy. On 30Dec2020 at 10:00, the patient experienced sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site. The patient did not receive any treatment for the events. The clinical outcome of the events sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
60 2021-01-08 injection site pain Fever "shaking", fever, and soreness at injection site Narrative:
60 2021-01-08 injection site pain Headache very fatigue, soreness at injection site Narrative: stayed home from work
60 2021-01-08 itchy skin c/o itching and pressure in her head. Narrative: c/o of itching and pressure in head. Staff gave Di... Read more
c/o itching and pressure in her head. Narrative: c/o of itching and pressure in head. Staff gave Diphenhydramine HCL VS 178/85, 72, 18, 98% O2sat. at 1340 states she felt better.
60 2021-01-08 rash papular, itchy rash, rash, rash with redness Had initial vaccine on 12/21/2020. Broke out in rash reported in a previous report file. After 2nd i... Read more
Had initial vaccine on 12/21/2020. Broke out in rash reported in a previous report file. After 2nd injection, at some of the exact locations of healing rash from 1st, new eruptions of red raised pruritic rash occurred. Lower abdomen, top of right ribs and nape of neck.
60 2021-01-08 rash, rash with redness, itchy rash Approximately 24 hrs after injectio rash occurred to groin area & lower abdomen. Then appeared in mu... Read more
Approximately 24 hrs after injectio rash occurred to groin area & lower abdomen. Then appeared in multiple patchy areas. Over next 10 days rash appeared on right of mid sternum, right upper ribs, coccyx area, nap of neck. Rash was small red bumps any extremely pruritic
60 2021-01-08 rash SkinRash & NauseaVomiting
60 2021-01-10 injection site redness, injection site pruritus Redness and itch at injection site for 48 hours
60 2021-01-10 injection site pain, blister, redness, skin warm 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 2021-01-10 injection site pain Injection site slightly sore to the touch, very slight sore throat and very slight headache
60 2021-01-10 injection site 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 skin burning sensation, rash On the 3rd day after the injection I felt a burning sensation on the skin of my neck then with in 10... Read more
On the 3rd day after the injection I felt a burning sensation on the skin of my neck then with in 10 minutes the feeling spread over my whole body. Not an itch just a burning and slight red patches on my: Neck, upper back and inner side of my arms. It wasn't like a hot flash I was expecting hive welts but that didn't happen.
60 2021-01-11 itchy skin, redness, rash Patient developed a rash on her neck beginning on the right side and continued to increase around he... Read more
Patient developed a rash on her neck beginning on the right side and continued to increase around her neck. She is still experiencing redness today. She also has some itching of her scalp. She did not require intervention.
60 2021-01-12 injection site rash, rash macular, rash with redness Received Pfizer vaccine on January 7 at approximately 5:20PM. This morning on January 13 at 5:20 AM... Read more
Received Pfizer vaccine on January 7 at approximately 5:20PM. This morning on January 13 at 5:20 AM, I noticed a rash on my left upper arm/deltoid at the vaccine site. Rash is flat and red, approximately 8 cm x 8 cm, but not circular.
60 2021-01-12 itchy skin Pfizer-BioNTech COVID-19 vaccine EUA - Client reports "after 45 minutes post injection, started hav... Read more
Pfizer-BioNTech COVID-19 vaccine EUA - Client reports "after 45 minutes post injection, started having mild itching in my trunk, arms and left Hand. itching increased so took Benadryl 50 mg PO, stayed for 15 minutes then left work to go home. Once home itching increased, eyes started swelling and started losing my voice. Husband took me to the ER at Hospital, arrived approx. 6.10 pm. Treated with Benadryl, Solu medrol and Pepcid, all thru IV. Condition improved and client sent home with script for Pepcid, Medrol dose pack and Atarax.
60 2021-01-12 rash papular, rash, rash with redness Initially, sore throat, body aches and headache, then on 1/11/21 she developed red raised rash on he... Read more
Initially, sore throat, body aches and headache, then on 1/11/21 she developed red raised rash on her neck and chest. Denies difficulty breathing however she reports her throat is very painful, scratchy, dry and irritated. For treatment patient took a zyrtec 24 hour 10 mg tablet on 1/11/21 which reduced some inflammation of rash, however still present 1/12/21. Has increased fluids, is taking tylenol and tea with honey. These were self care done by patient. MD suggested to Zyrtec every 6-8 hours as needed for symptom control. Ibuprofen / tylenol as needed for headache if no provider has told you not to use these in the past. If any progressive Sx than you should be seen at URI clinic.
60 2021-01-12 vaccination site pain Her arm was a little sore; The soreness at the injection site lasted 2 days; This is a spontaneous r... Read more
Her arm was a little sore; The soreness at the injection site lasted 2 days; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration (arm left) on 08Dec2020 (lot unknown) at SINGLE DOSE; and second dose via an unspecified route of administration on 06Jan2021 at SINGLE DOSE (lot number EJ1685) for COVID-19 immunization. The patient medical history was not reported. The patient was taking unspecified concomitant medications (same medications that she usually takes and has not started anything new). Patient reported that she was fine after the first shot. Her arm was a little sore on Dec2020 and that was it. The soreness at the injection site lasted 2 days and then recovered completely. She has no breathing difficulties or anything similar. Outcome of the event "Her arm was a little sore" was unknown while recovered for " The soreness at the injection site lasted 2 days" on Dec2020.
60 2021-01-13 shingles 4 days after receiving Covid shot in left arm, shingles appeared on right scapula area, 3 days late... Read more
4 days after receiving Covid shot in left arm, shingles appeared on right scapula area, 3 days later shingles appeared on right upper lateral arm form shoulder to forearm
60 2021-01-13 itchy skin Patient received her first dose of COVID-19 vaccine at 9:27 am. Around 9:40, the patient complained ... Read more
Patient received her first dose of COVID-19 vaccine at 9:27 am. Around 9:40, the patient complained of head tingling and body itchiness.
60 2021-01-14 injection site redness 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 itchy skin, injection site pain Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus,... Read more
Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down. She went to see her doctor last week and was treated with benadryl.
60 2021-01-14 itchy skin 10 minutes after receiving vaccine pt. c/o severe itching on face and neck. No hives, shortness of ... Read more
10 minutes after receiving vaccine pt. c/o severe itching on face and neck. No hives, shortness of breath or distress noted. Pt. declined to take Benadryl or Epinephrine - requested to go to hospital for evaluation.
60 2021-01-14 itchy skin I got the vaccine in the AM and I was fine all day just a little itchy in the morning. Around 2AM in... Read more
I got the vaccine in the AM and I was fine all day just a little itchy in the morning. Around 2AM in the morning I had high fever, chills, and a very bad headache, and shooting pain like a shock in legs and arms (I had the same when had covid around 04/2020 and was out of work until June 2020 - I developed double pneumonia). It lasted until 11AM the next day. Got a covid test around noon and it was negative and on the 25th I started feeling better. Got second dose on 01/13/2021 had the same symptoms but not as severe.
60 2021-01-14 hives About 15 minutes after injection c/o mild tingling to lips. No other symptoms. VSS (BP 103/68, O2 99... Read more
About 15 minutes after injection c/o mild tingling to lips. No other symptoms. VSS (BP 103/68, O2 99%, RR 17, HR 68). no wheezing, SOB, swelling, chest pain, dizziness, abd pain, NV. about 15 minutes later, lip tingling improved but began c/o generalized urticaria with mild erythema to left upper chest. patient well appearing at that time, A&Ox3, no increased WOB, SOB, hives, facial swelling, facial redness. Patient reports she experienced same urticaria about 24-48 hours after 1st COVID vaccine dose, treated at home with po benadryl with improvement. Placed on continuous monitoring and administered 25 mg Benadryl po with improvement in symptoms. About 30 min after benadryl administration symptoms resolved. Offered ER evaluation to which patient declined. She works within hospital and agrees to seek emergency medical care should symptoms return or worsen. can continue to take benadryl at home and monitor closely.
60 2021-01-15 injection site pain Soreness at injection site x 48 hours--no treatment Slight twitching in left eyelid x 48 hours--no t... Read more
Soreness at injection site x 48 hours--no treatment Slight twitching in left eyelid x 48 hours--no treatment--still have a little twitching in the eye but seems to be getting better
60 2021-01-15 injection site pain soreness at site x 24-48 hours--no treatment slight twitching of left eye x 1 week--no treatment
60 2021-01-15 rash, itchy skin Arm and joint pain, itching, rash
60 2021-01-17 injection site pain, injection site redness, injection site warmth I received the Pfizer COVID-19 vaccine on 1/7/21 which resulted in slight redness and soreness at th... Read more
I received the Pfizer COVID-19 vaccine on 1/7/21 which resulted in slight redness and soreness at the site. This gradually dissipated over a few days, but not completely. On Friday, 01/15/21 a couple hours after exercising (elliptical and hand weights) at the site of vaccination was redness, soreness, and heat. Upon waking up Saturday, 01/16/21, the redness, soreness, and heat had increased - area was 6cm x 7cm - contacted pcp and was advised to go to Urgent Care, which I did and was prescribed Doxycycline for possible cellulitis. Today, 01/18/21, sx's have much improved.
60 2021-01-17 itchy skin itching all over, restlessness, patient allergic to benadryl.
60 2021-01-17 itchy skin patient states that she had a reaction with the first vaccine but not until after she left the clini... Read more
patient states that she had a reaction with the first vaccine but not until after she left the clinic here. She states she had tingling in her lips and throat, she states she has already taken Benadryl 25mg prior to coming here today. Within 10 minutes of receiving vaccine she began with tingling of throat and lips, feeling woozy and ears itching. After speaking with healthcare worker the patient was given Benadryl 25mg IM. A medical alert was then called due to patient c/o chest pain. She was taken to the ER as a precaution.
60 2021-01-17 itchy skin itching all over
60 2021-01-17 itchy skin PATIRNT PRESENT THROAT AND BODY ITCH
60 2021-01-17 rash Clammy, sweating and rash to BUE and chest. Patient will be seeing PCP for treatment.
60 2021-01-18 itchy skin Pt presented with itchy hands, itchy face
60 2021-01-18 itchy skin 6PM DAY OF SHOT ITCHING IN EXTREMITIES LOWER LEGS AND ARMS JUST ABOVE WRIST. PAINFUL LOWER BACK PAIN... Read more
6PM DAY OF SHOT ITCHING IN EXTREMITIES LOWER LEGS AND ARMS JUST ABOVE WRIST. PAINFUL LOWER BACK PAIN. TOOK TWO BENEDRYL AND SYMPTOMS RESOLVED BY AM. 1/16 HAD SYMPTOMS OF AN ON-COMING COLD, SLIGHT SORE THROUGH, SINUS PRESSURE AND FELT WARM. NO TREATMENT OTHER THAN FLUIDS AND REST AND RESOLVED BY MORNING. 1/17 AND 1/18 ONLY SYMPTOM MILD FATIGUE
60 2021-01-18 rash began having tingling to face & tongue @ approx 0915 progressed to tongue and mouth swelling and ras... Read more
began having tingling to face & tongue @ approx 0915 progressed to tongue and mouth swelling and rash to face
60 2021-01-19 itchy skin 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 2021-01-20 injection site pain, injection site swelling, injection site redness, injection site pruritus Injection site got really red started about a quarter in diameter and swelled to about 9 inches in ... Read more
Injection site got really red started about a quarter in diameter and swelled to about 9 inches in diameter. Itched and was painful. Lasted about 1 weeks time. Ibuprofen and diphenhydramine.
60 2021-01-20 rash macular taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the co... Read more
taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the corners of my mouth; sore arm; nausea; headache; This is a spontaneous report from a contactable consumer. This consumer reported for that the 60-year-old female patient who received first dose of bnt162b2 (Pfizer Pfizerbiontech covide-19 Vaccine EUA), via an unspecified route of administration on 03Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. She is not pregnant. Medical history included Known allergies: Penicillin sulfa. No other vaccine in four weeks. Concomitant medications included in two weeks: escitalopram oxalate (LEXAPRO), valaciclovir hydrochloride (VALTREX). The patient experienced Day 1 sore arm, nausea, headache from 05Jan2021 12:00AM, Day 2 nausea from 06Jan2021, Day 3 rash around the corners of my mouth from 07Jan2021, Day 4 bumps on roof of mouth from 08Jan2021, Day 5 red spots on roof of mouth from 09Jan2021, Day 6 Continued red spots went to Doctor, Day 7 taking new meds for allergic reaction from 11Jan2021, Day 8 headache mouth improving. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Treatment was received included Doxycycline. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
60 2021-01-20 hives, itchy skin 1. Fever lasting 30 hours. It began approximately 11 hours after my shot, and ended 30 hours later.... Read more
1. Fever lasting 30 hours. It began approximately 11 hours after my shot, and ended 30 hours later. Fever ran about 102 degrees most of the time. 2. Chills 3. Loss of appetite and body aches lasting approximately 3 days 4. Hives in armpits, worse on the side of the injection. I noticed it 48 hours after the injection, and I still have them 1 week later. They are much better, but still visible and itchy. 5. Sensitive and painful gums
60 2021-01-21 rash INJECTION 1===back ache, heat from waist down to top of knees, no fever INJECTION 2===rash on top of... Read more
INJECTION 1===back ache, heat from waist down to top of knees, no fever INJECTION 2===rash on top of both legs- no fever
60 2021-01-24 bruising BRUISING, IT STARTED ON LEFT THIGH AND WENT TO LOWER LFT ABDOMEN WITH FIRST INJECTION. AFTER 2ND IN... Read more
BRUISING, IT STARTED ON LEFT THIGH AND WENT TO LOWER LFT ABDOMEN WITH FIRST INJECTION. AFTER 2ND INJECTION IT WENT TO THE RIGHT THIGH AND HAD SMALL BRUISES.
60 2021-01-24 injection site bruising, injection site pain 12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours l... Read more
12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours later turned into sweating/heat. Mild upset stomach throughout. Soreness/brusing at injection site. After 18 hours headache persisted with mild body aches and upset stomach. Still soreness /brusing at injection site. 24 hours after injection very mild backache. No headache. Soreness at injection site. No other issues.
60 2021-01-24 injection site bruising Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; T... Read more
Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; Things started looking funny/ Funny feeling in her ears; Deaf and couldn't hear; Leg cramps in both legs and toes curled out/ muscle spasming; Dizzy; nauseous; Threw up twice; Bruise at injection site; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3246) via an unspecified route of administration on the arm left on 05Jan2021 around 12:00 PM at single dose for COVID-19 immunization. The patient used to get legs cramps when she was pregnant with her twins, but it was only one leg. The patient stated she delivered six children, was in car accidents, and had surgeries. And the patient stated the pain from the COVID-19 Vaccine was beyond any other pain she has experienced. The patient needed glasses to read patient card. And stated her eyesight was going. The patient was pretty healthy. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks. And the patient did not receive additional vaccines on same date that administered BNT162B2. The patient experienced deaf and couldn't hear on 06Jan2021 09:00, leg cramps in both legs and toes curled out on 05Jan2021 19:00, dizzy on 05Jan2021, nauseous on 05Jan2021, threw up twice on 05Jan2021, things started looking funny on 06Jan2021 09:00, pain through whole body and tremoring on 06Jan2021 10:00, bruise at injection site on Jan2021. All the events (except for event bruise at injection site) were reported as seriousness as life threatening. Clinical course: the patient worked nightshift. Laid down that afternoon to take a nap and got up around 10:00. Around 05Jan2021 19:00 PM had sever leg cramps in both legs where her toes were curled out. Leg cramps after vaccine wouldn't go away and it was in both legs. Just wouldn't go away. Around 05Jan2021 21:00 PM it went away. The patient was dizzy, nauseous, and threw up twice on the night of 05Jan2021, and going into 06Jan2021. The patient went to the couch in the hotel room and started going deaf. She couldn't hear anything on 06Jan2021 around 09: 00 AM. Things started looking funny on 06Jan2021 around 09: 00 AM. Woke up at 09:35. Hour after that there was pain through her whole body and everything was hurting at 10:00 AM on 06Jan2021. The patient was tremoring at 10:00 AM on 06Jan2021. Couldn't reach the phone to dial 9-11. Thought she was going to die. Last until about noon and then started to go away. Doesn't know if it is safe to take the second vaccine. Doesn't know if these are thing that should have happened to her. She started to get real concerned. Went into hotel room and started feeling dizzy again. Stopped haring things. Funny feeling in her ears. Was seeing things, got dizzy, and everything got dark. Everything lasted until 12:00 PM on 06Jan2021. Everything was good now. The patient had a bruise where injection was in Jan2021. Stated it was nothing compared to what she went through. Woke up around 10:00 AM. Then went back to sleep and got up around 18:00 PM. She felt fine. Her whole body was sore from the muscle spasming. The outcome of the event bruise at injection site was unknown, of the event leg cramps in both legs and toes curled out was recovered around 05Jan2021 21:00, the outcome of other remain events was recovered on 06Jan2021 12:00. The reporter considered (method of assessment: Global Introspection) that all the events were related to BNT162B2.; Sender's Comments: All the reported events were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, it is worth noting that the 60-year-old female patient had car accidents history and had surgeries. All the events started when she worked nightshift, including leg cramps in both legs and toes curled out, nauseous, threw up twice, pain through whole body, tremoring and transient deafness. Patient did not get rest after vaccination may a risk factor to the onset of the events. 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 2021-01-24 injection site swelling, injection site pain Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at s... Read more
Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at site of injection with swelling- took total of 4 tylenol over a course of 20 hours- symptoms lasted about 20 hours- arm swelling and pain lasted about 3 days
60 2021-01-24 itchy skin, hives, rash I had a rash on my face, started with itchy nose and eyes. The hives spread to the neck. I told the ... Read more
I had a rash on my face, started with itchy nose and eyes. The hives spread to the neck. I told the male nurse that was present and he said that had Epinephrine, I had benadryl and he said that I could take one. Half an hour later my rash got worse and I took 20 mg prednisone that I had for my asthma. During the next two days I have had palpitations, fatigue and tiredness. Today my blood pressure was high and I have never had it like that before.
60 2021-01-24 itchy skin, hives 7 hours after the injection, I broke out in hives in my torso. Over the next 2 days, it has spread ... Read more
7 hours after the injection, I broke out in hives in my torso. Over the next 2 days, it has spread to my whole body. I am taking Benadryl to try to relieve the itching.
60 2021-01-24 hives Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate... Read more
Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer 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 2021-01-25 redness 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 2021-01-25 injection site pain Slight fever, 99.2, with chills and muscle aches. Event occurred about 2:00 am on 01/26/2021. I took... Read more
Slight fever, 99.2, with chills and muscle aches. Event occurred about 2:00 am on 01/26/2021. I took a Tylenol went back to bed. No fever upon waking. Minor muscle aches and mild soreness at injection site.
60 2021-01-25 rash with redness Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestio... Read more
Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestion; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown, vaccine location: right arm), intramuscular on 04Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included hypertension/high blood pressure controlled, GERD/acid reflux, fast heart rate, and prediabetic. Concomitant medications included losartan, metoprolol, gemfibrozil (LOPID), aspirin [acetylsalicylic acid], atorvastatin, vitamin D3, zinc, magnesium, ascorbic acid (VIT C), vitamin B complex (VIT B COMPLEX), alpha-d-galactosidase (BEANO), angelica keiskei leaf, sambucus nigra extract (SAMBUCOL), and unspecified stress supplement. The patient is not pregnant. The patient received a flu shot administered on the right arm on 28Oct2020 and pneumo vacc administered on the left arm on 28Oct2020. The patient received no other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: COVID PCR) on 22Dec2020 with result negative. On 04Jan2021 13:15, the patient experienced bumpy red rashes in arms and legs, shortness of breath, mild chest pain, severe dizziness, and congestion. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering. Information about lot/batch number has been requested.
60 2021-01-25 rash, injection site pruritus, injection site rash 1 hour after vaccine -itchy injection site and small rash starting on top of left arm, took 50mg of ... Read more
1 hour after vaccine -itchy injection site and small rash starting on top of left arm, took 50mg of Benadryl 1 hour after Benadryl- rash was spreading to the whole arm , neck and intermittent labored breathing started patient was taken to hospital and received 2 doses of epinephrine and nebulizer treatment
60 2021-01-25 rash, itchy skin, redness 25 minutes status post the vaccine patient experienced head itchiness. Patient was brought to the tr... Read more
25 minutes status post the vaccine patient experienced head itchiness. Patient was brought to the triage room and had fine rash on chest. BP noted to be 190/90, HR 60, RR 16, sat 100%, and no SOB/difficulty breathing. Allergy on call was paged and patient was given zyrtec. After given zyrtec patient was monitored for two hours. There was a redness on patient's neck which was continually lessened, HR, RR, and sat remained stable throughout. Sat remained between 150-170 for the next hour. After 2 hours the redness on neck has completely resolved and BP 153/79. Allergist on call notified. Plan was to have patient go to ER if she experienced SOB, chest pain, or headache.
60 2021-01-25 vaccination site rash, redness Received Pfizer vaccine on January 7 at approximately 5:20PM. This morning on January 13 at 5:20 AM... Read more
Received Pfizer vaccine on January 7 at approximately 5:20PM. This morning on January 13 at 5:20 AM, I noticed a rash on my left upper arm/deltoid at the vaccine site. Rash is flat and red, approximately 8 cm x 8 cm, but not circular.
60 2021-01-26 bruising First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and ... Read more
First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.
60 2021-01-26 dry skin, skin tightness, rash, redness There are two events I am reporting, one each from the first dose on 12/19/20, and the second dose o... Read more
There are two events I am reporting, one each from the first dose on 12/19/20, and the second dose on 1/9/21: Approximately 53 hours after Dose #1: Redness on hands and wrist, rash-like small dot appearance on hands and wrists, skin dryness and tightness of hands. I experienced no itching of hands or wrists. Approximately 53 hours after Dose #2: Small, painful red pustule-like occurrence on base of right thumb, with the appearance of a few small dots in it. I experienced no itching of thumb or hand. These events both occurred within the same timeframe following the vaccine doses. Following the first event I was seen in the ER. I checked out fine and they could not say exactly what this was. They said it did not appear to be an allergic reaction to the vaccine because it was not systemic and I had no other symptoms such as trouble breathing. They thought perhaps it was coincidental...I work in the hospital as a radiologic technologist where I hand-wash and hand-sanitize all day. Perhaps I just over-washed that day? However I've worked there for 17 years and never had this happen. The redness and rash dissipated by end of day. Following the second event I did not follow up with any medical provider. This pustule I got happened while I was at home, and otherwise I felt fine so I left it at that. It took several days for the pustule to go away. I hope you don't mind but I am writing to report this information in the event it may be helpful to you and I am also reporting it because I want to know if what I experienced could be considered an immune response to the vaccine? Another words, not an allergic response but an immune response ? I can find absolutely nothing about this on-line and no one knows what to make of it. Thank you.
60 2021-01-26 itchy skin, hives, redness, rash RASH STARTED 2 DAYS AFTER VACCINE ON MY WRISTS, AND SLOWLY WENT UP MY ARMS BY SUNDAY MORNING. BY MO... Read more
RASH STARTED 2 DAYS AFTER VACCINE ON MY WRISTS, AND SLOWLY WENT UP MY ARMS BY SUNDAY MORNING. BY MONDAY MORNING RASH WAS ON MY LEGS, CHEST, BACK AND ARMS. ITCHY, RED AND RAISED WELTS IN PLACES. JUST UNCOMFORTABLE. IT'S NOW WEDNESDAY AND IT'S SLOWLY GOING AWAY, STILL RED AND ITCHY. I DID NOT GO TO MY PCP. I DID SHOW MY RASH TO MY INFECTIOUS DISEASE PHYSICIAN AT OUR HOSPITAL. I HAVE BEEN TAKING AN ANTIHISTAMINE THAT HAS HELPED.
60 2021-01-26 skin peeling, itchy rash, rash papular, rash, hives, itchy skin, rash vesicular like an anaphylactic reaction but not in her throat; itching and inflammation, in eyes as well/eyes ... Read more
like an anaphylactic reaction but not in her throat; itching and inflammation, in eyes as well/eyes were swollen and itchy; itching and inflammation, in eyes as well; swelling on her eyes and itching on her eye lids; swelling on her eyes and itching on her eye lids; welts; whelps on her hip, inflamed and itchy/general arthritis symptoms; Headache dull; shingle like rash on tailbone, genital area / raised itchy rash on the tailbone like shingles; itching on her face that she couldn't see / raised itchy area on her left cheek and eyes; rash / rash down her thighs/rash that was across her body; rash vulva; swelling / vulva was swollen; itching / itching around the genital area, vulva; itching / itching around the genital area, vulva; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse (patient) worked in outpatient mental health reported that a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, Expiry Date: Apr2021) via an unspecified route of administration on 04Jan2021 at 16:20 in the left arm at single dose for COVID-19 vaccination. Vaccine administered at hospital and not military facility. No additional vaccines administered on same date of the Pfizer suspect. Medical history included ongoing Graves' disease (the patient had her thyroid irradiated away for Grave's disease 25 years ago). Family Medical History was none. Concomitant medication included ongoing levothyroxine 1.25 mcg once daily by mouth Graves' disease taking for 25 years. Prior vaccination within 4 weeks was none. The patient received her Pfizer COVID 19 vaccine on 04Jan2021. Since then she started to experience a genital itch immediately; a rash that was across her body; eyes were swollen and itchy; new itchy rash 13Jan2021. She felt okay going home then she started to have itching around the genital area. She thought she might have a yeast infection but she didn't have any other symptoms for a yeast infection. Her vulva became swollen from 05Jan2021 and itchy from 04Jan2021 and she noticed rash around her body. It all started in the genital area. The next day the rash spread down her thighs and she noticed an itchy place on her face, but you couldn't see it. Her thighs were inflamed and she noticed patches of angry whelps on her hips as well as a itchy rash area on her tailbone that seemed more like shingles; size of a quarter; raised, itchy, rash, that felt like it was radiating out. Then she noticed the rash on her face on her cheek, general swelling on her eyes and itching on her eye lids. Now the genital itching was less and most of her symptoms were improved but her eye was driving her crazy and it was more swollen on the outside. She tried to treat her eyes with eye drops Dry Eye Relief (manufacturer Similasan; no UPC seen, lot number: 15942; expiration date: Sep2022, ingredients include Belladonna) but it didn't help. They were still itchy and weepy. The eye drops were not working. She also treated the rash and itching with Benadryl at night and it improved the symptoms overall. She took Tylenol (UPC 300043760; lot number: PMA003; expiration date: Aug2022) and Bayer Aspirin (81mg; lot number: NAA93E1; expiration date: Feb2023. No UPC code on bottle) every day for general arthritis symptoms, but they didn't touch her dull headache she has had on and off since the vaccine. Before she got the vaccine, she had a little tag on her vulva, it was tiny. Now after experiencing the itching, swelling, rash on her vulva, the tag was gone. It just took a layer of skin right off. It was not uncomfortable but the whole layer of the skin was gone. It was very uncomfortable while it was happening but now it was okay. When she noticed these symptoms, she tried to call occupational health and a institute but didn't get anyone. She also contacted her HCP but had not heard back. It seemed to her like a lot of side effects and a lot of itching. She didn't have it in her throat, but all that itching seems a lot like an anaphylactic reaction. She was curious whether we would recommend her to take the second dose since they say the reaction to the second dose was worse. She had multiple COVID tests that have all come back negative. A friend tested positive so she had a test; and she had a test when she traveled. The events did not require a visit to physician or emergency room. The patient had reactions: itching, rash, swelling, welts, shingle like rash on tailbone, genital area, hips moving to her face, itching and inflammation, in eyes as well. She wanted to know if the 2nd dose was recommended. It was "like an anaphylactic reaction but not in her throat." itching around the genital area, vulva started from 04Jan2021, vulva was swollen started from 05Jan2021; Rash vulva started from 06Jan2021 to 10Jan2021; rash down her thighs started from 07Jan2021; Raised itchy rash on the tailbone like shingles started from 06Jan2021, whelps on her hip, inflamed and itchy from 07Jan2021; itching on her face that she couldn't see started from 06Jan2021; raised itchy area on her left cheek and eyes started from 07Jan2021; Headache dull started from 06Jan2021. The events Headache dull, itching on her face that she couldn't see; whelps on her hip, inflamed and itchy and raised itchy rash on the tailbone like shingles were reported as non-serious by the reporter and other events were considered as medical significant by the reporter. Investigation assessment for the events was reported as No. The outcome of the event anaphylactic reaction, inflammation in eye, welts was unknown, outcome of the event Rash vulva was recovered on 10Jan2021; of Headache dull, swelling eye was not recovered, of other events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
60 2021-01-27 injection site 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 injection site rash, injection site warmth, injection site redness Red, warm rash around injection site cold sweat, chills, and swelling to Left arm
60 2021-01-27 rash Rash across face, part of her cheeks over her nose; Arm sore; Received two vaccine within 10 minutes... Read more
Rash across face, part of her cheeks over her nose; Arm sore; Received two vaccine within 10 minutes of each other and now to be re-vaccinated again the second dose; not enough research can guarantee if that's safe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0140, expiry:Mar2021), intramuscular on 12Jan2021 at a SINGLE DOSE then intramuscular on 12Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included blood cholesterol increased, fistula, surgery on 18Dec2020. It was stated, "Sure, I am hoping you can help me. I am one of the legal guardians for our younger sister who has special needs. She is residing in a group home, group home in the city area she is currently been out of it because she has surgery. They have made arrangements for them to still ask for them to receive the first Pfizer Covid 19 Vaccination just this past Tuesday so I go from up there from my home in city and we had a problem in there they screwed up and ended up vaccinating her twice within 10 minutes. I asked the pharmacist, there I asked the RN what does that mean for her I mean I didn't know what that meant but normally we would sat for 15 minutes, they made her sat for 30 minutes. The nurse was there from the group home monitored her blood pressure and temperature and then we got in the car proceeded to drive 3 and half hour. They said just watch for temperature, labored breathing, take her to the emergency room call 911, the only thing she did have about an hour after she broke out that was "malar" (not clarified) rash across her face part of her cheeks over her nose that lasted for about 30 minutes. The next day her arm was sore which was going to happen but here is my question though she received two vaccine within 10 minutes of each other and now they are wanting her to be re-vaccinated again which would have been the second dose, supposedly on 02Feb2021. Nobody can tell me if that's safe or if that's okay, they can't guarantee, they all kept telling me, the nurse says, I called the pharmacist kept saying there's not been enough research to know if it's safe for her to get that next vaccine, so I don't know what to do." The reporter also stated, "IM, Both went for IM, first one went into her left arm and second shot was given in her right arm." The patient underwent lab tests and procedures which included blood pressure measurement: unknown result on an unspecified date, blood test: unknown result on 05Jan2021, body temperature: unknown result on an unspecified date, sars-cov-2 test: unknown results pre-surgery and post-surgery. The outcome of the event rash across face, part of her cheeks over her nose was recovered and arm sore was unknown.
60 2021-01-27 vaccination site pain tongue on the side is bruised; it was a big black spot that she noticed this morning while brushing ... Read more
tongue on the side is bruised; it was a big black spot that she noticed this morning while brushing her tooth; right arm being sore started after 1.5 hours after the shot; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose in the right arm for covid-19 (immunization). There were no medical history and concomitant medications. Patient had got her Pfizer Covid vaccine on 13Jan2021 and thought she had a reaction and wanted to know if anyone had this reaction. On 14Jan2021, patient stated on right side where got shot on that her tongue on the side was bruised. She stated that her arm hurt last night. She stated this was her first dose. She later clarified that it was her right arm. Patient stated that it was a big black spot that she noticed this morning while brushing her tooth (14Jan2021). Her right arm being sore started after 1.5 hours after the shot (13Jan2021). No treatments received in response to the events reported. The events "tongue on the side was bruised" and "it was a big black spot that she noticed this morning while brushing her tooth" were not recovered. The outcome of the event "right arm being sore started after 1.5 hours after the shot" was recovered on 14Jan2021.
60 2021-01-28 redness, rash, injection site reaction I received the vaccine at approximately 8:10 a.m. Approximately 12 hours post-injection, I began to ... Read more
I received the vaccine at approximately 8:10 a.m. Approximately 12 hours post-injection, I began to feel malaise and fatigue. Upon waking around midnight, I had developed a 102.4 degree (F) fever, total body ache, headache, chills, and cough. Most symptoms lasted approximately 24 hours. The headache, although now mild, persists into the third day. On the third morning following the injection, I woke to find a slightly painful triangular-shaped red, raised patch on the same arm as the injection (left). The "rash" measures approximately 4.5 cm x 7 cm.
60 2021-01-28 redness 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 2021-01-28 itchy skin itchy, swollen soft pallet, need to cough started approx. 15 mins after vaccine given and continued ... Read more
itchy, swollen soft pallet, need to cough started approx. 15 mins after vaccine given and continued and plateaued for hour and half. Benadryl and prednisone given in ED. Monitored and D/C with no further progression of sx.
60 2021-01-28 rash with redness, rash Swelling of lips and tongue Intense itching Bright red rash on neck, face
60 2021-01-29 redness, itchy skin 2? diameter redness/swelling, soreness, some itching, resolved after 2 days
60 2021-01-31 injection site swelling, injection site pain 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 2021-01-31 rash, itchy rash, rash macular Patient received their first dose of Pfizer vaccine on 1.27.2021. Patient reports little red spots t... Read more
Patient received their first dose of Pfizer vaccine on 1.27.2021. Patient reports little red spots that are itchy on their legs, thighs, and chest that started the day after receiving the vaccine. The patient states that they are NOT experiencing any facial swelling, scratchy/itchy throat/ShOB. Patient states the rash has improved with over the counter medications. Encouraged the patient to reach out to provider with any more worrisome or bothersome conditions, including worsening of rash. Reviewed when the patient should seek emergency care.
60 2021-02-01 injection site nodule 6 days after injection, I noticed a 5x5 cm sized lump under my left arm.
60 2021-02-01 injection site pain, injection site redness, injection site mass, injection site warmth headache, joint & bone pain, red lump at injection site, injection site warm to the touch, soreness ... Read more
headache, joint & bone pain, red lump at injection site, injection site warm to the touch, soreness at injection site, some wheezing 40 x 40 mm
60 2021-02-01 injection site pain Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On ... Read more
Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On 1/25/21 I also had fever (highest was 101.4), chills, weakness, and aching bones. I also had a terrible headache that started 1/20 and lasted until 1/ 28 or 1/29. There was the normal injection site soreness on the evening of the first day.
60 2021-02-01 injection site pain Arm sore at site.
60 2021-02-01 itchy skin, redness noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; noticed 3 lumps the ... Read more
noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; This is a spontaneous report from a contactable consumer reported for self. This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EK9231) at single dose on left arm on 03Jan2021 at 0830AM for COVID-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Medical history was none. Family medical history was none. Relevant test was none. Prior Vaccinations (within 4 weeks) was none. There was no concomitant medication. Patient received 1st dose on 03Jan2021. Yesterday (18Jan2021), she noticed 3 lumps the size of finder tip on her shoulder that were red and itchy. Across her cleavage, she noticed another 3-4 lumps. She noticed last night, 18Jan2021, three lumps on her shoulder that were really itchy and red and three or four across her cleavage area but not as large. She was just checking, she knew it said could have swollen lymph glands. Patient mentioned she tried to set the phone thing set up where they call you but she could not do it. The shoulder lumps were on her left side and about the size of tip of her little finger. She tried Witch Hazel; she rubbed it on and that soothed it a little at that time. she was scheduled for the second dose of the vaccine on the 25Jan2021. Patient asked if this was normal and what could the end result possibly be. The adverse events did not require a visit to physician or ER. The outcome of events was not resolved.
60 2021-02-01 itchy rash, injection site rash, rash with redness, rash papular Rash raised, red, warm, and itchy in area covering about 7 cm underneath injection site. This starte... Read more
Rash raised, red, warm, and itchy in area covering about 7 cm underneath injection site. This started on Feb. 2. Also had fever of 100 degrees, body aches, headache for about 36 hours, it started 12 hours after I received the vaccine.
60 2021-02-01 rash, itchy rash, shingles Developed chills, a low grade fever and headache on same day of her vaccination. The next day, she ... Read more
Developed chills, a low grade fever and headache on same day of her vaccination. The next day, she developed an itchy rash on her left arm which became panful. She saw her PCP who diagnosed shingles.
60 2021-02-01 sensitive skin Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, s... Read more
Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, sensitive to touch, movement and unable to lift arm beyond 45 degree angle. 17 hours after vaccine chills, fever of 102, muscle aches, severe headache, fatigue. 53 hours after vaccine, fever 101, severe headache, muscle aches, fatigue. Arm pain much less severe.
60 2021-02-01 skin warm, redness FEVER FOR ABOUT 24 HOURS, HEADACHE FOR ABOUT 24 HOURS AND LEFT ARM RED AND WARM TO TOUCH FOR 36 HOU... Read more
FEVER FOR ABOUT 24 HOURS, HEADACHE FOR ABOUT 24 HOURS AND LEFT ARM RED AND WARM TO TOUCH FOR 36 HOURS
60 2021-02-01 vaccination site pain, vaccination site redness, vaccination site warmth slight redness and soreness at the site/at the site of vaccination was redness, soreness, and heat; ... Read more
slight redness and soreness at the site/at the site of vaccination was redness, soreness, and heat; slight redness and soreness at the site/at the site of vaccination was redness, soreness, and heat; at the site of vaccination was redness, soreness, and heat; possible cellulitis; This is a spontaneous report from a contactable other HCP. A 60-years-old female patient receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 16:45 at single dose (lot number: EK4176) for covid-19 immunisation. Medical history included hypertension (HTN), anxiety, arthritis, seasonal allergy, known allergies: Penicillin, Sulfa, Bactrim. No covid prior vaccination. Concomitant medication included losartan, citalopram, cetirizine. The patient experienced vaccine resulted in slight redness and soreness at the site. This gradually dissipated over a few days, but not completely. On 15Jan2021 a couple hours after exercising (elliptical use and hand weights) at the site of vaccination was redness, soreness, and heat. Upon waking up 16Jan2021, the redness, soreness and heat had increased - area was 6cm x 7cm - contacted pcp and was advised to go to (urgent care withheld) which she did and was prescribed Doxycycline for possible cellulitis. Today 18Jan2021, redness, soreness, and heat have much improved. Treatment received for the events. Events resulted in physician office/clinic visit. Outcome of events was recovering.
60 2021-02-02 itchy skin Developed Itching and feeling of tightness in back of nose/throat. Advised employee to go to ED. Was... Read more
Developed Itching and feeling of tightness in back of nose/throat. Advised employee to go to ED. Was given 1L fluid, Solu-Medrol and Benadryl. No swelling of airways was observed and no respiratory distress noted. ED discharged patient to home.
60 2021-02-02 hives, rash, itchy skin Itching, rash, hives
60 2021-02-03 injection site pain minor local injection site pain , SOB, palpitation, chest tightness. 1/14 sx started and she reporte... Read more
minor local injection site pain , SOB, palpitation, chest tightness. 1/14 sx started and she reported to job 1/15. She had hard time to ambulate wearing a facemask. 1/17 sx fully resolved.
60 2021-02-04 skin spots admitted to hospital with platelet count of 8,000; petechiae; This is a spontaneous report from a co... Read more
admitted to hospital with platelet count of 8,000; petechiae; This is a spontaneous report from a contactable physician. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) via Intramuscular on 18Jan2021 into left arm at a single dose for covid-19 immunization. Medical history included hypothyroidism and neomycin allergies. The patient did not get covid prior vaccination. Concomitant medications included calcium, levothyroxine sodium (SYNTHROID), trazodone, tocopherol (VIT E) and no other vaccine in four weeks. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9261) via Intramuscular on 28Dec2020 into left arm at a single dose for covid-19 immunization. 24 hours after injection she developed petechiae and was admitted to hospital with platelet count of 8,000 on 20Jan2021 22:00, the patient has ITP with baseline platelet count of 60,000. All events lead to hospitalization for 5 days (PENDING CLARIFICATION) and received IgG and oral Dexamethas as treatment. On 20Jan2021, the patient did Sars Co V 2 RNA test via Nasal Swab and result negative. The outcome of the events was recovering.; Sender's Comments: Based on a close chronological association, a causal relationship between events petechiae and thrombocytopenia and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The case will be reevaluated 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 2021-02-04 rash At 2:30 pm after being in observation for 30 minutes, patient became concerned about a rash to her l... Read more
At 2:30 pm after being in observation for 30 minutes, patient became concerned about a rash to her left arm. There was a small area that had a lace modeling appearance. Patient denied any pain or itchiness to this area and there were no hives. Patient very anxious and concerned and asked if she could take her own liquid Benadryl which she had on hand. She was offered Benadryl from the clinic but refused and really wanted to take her own. Approval from supervisor obtained and Benadryl was verified. VS BP 110/60, HR 76 and pulse ox 98% at 2:35 pm. Patient denied any other signs and symptoms of allergic reaction except anxiety. VS repeated at 2:55pm and were; BP 110/60, HR 68, Pulse ox 100%. No change in condition and patient felt good enough to leave. Patients sister accompanied her to the clinic today and will stay with her tonight.
60 2021-02-05 injection site reaction, hives Nothing major. A weeping painful welt to the right of injection site started overnight on the day o... Read more
Nothing major. A weeping painful welt to the right of injection site started overnight on the day of injection. Did not report Subsided several days later
60 2021-02-05 rash Client complaining of rash on upper chest and feeling flush . evaluated by EMS. BP 140/94, P 90, O2 ... Read more
Client complaining of rash on upper chest and feeling flush . evaluated by EMS. BP 140/94, P 90, O2 97% Lungs clear.Client called family to pick her up and take to her PCP.
60 2021-02-06 rash Developed rash at back. Resolved spontaneously at one week post vaccination. Vaccine #2 given 3 week... Read more
Developed rash at back. Resolved spontaneously at one week post vaccination. Vaccine #2 given 3 weeks later @ 2/7/21. Rash reported when patient came in for Pfizer vaccine #2 (after resolved). Did not report to healthcare system or present to medical care for evaluation.
60 2021-02-07 itchy skin Pt had vaccine at about 1pm, did well, went back to work. At 2pm, pt came back to say she was itchin... Read more
Pt had vaccine at about 1pm, did well, went back to work. At 2pm, pt came back to say she was itching all over arms, back hands, scalp. BP 138/62, gave one diphenhydramine 25mg po. At 2:15-- same symptoms, no worsening. At 2:30pm, per pt less itchy; NO n/v; NO thickening feel of tongue/throat; pt will take Allegra at 6pm; will notify Dr/ER if any worsening of symptoms
60 2021-02-07 rash, vaccination site pain injection site pain; chills; muscle aches; fatigue; Rash on torso, arms; This is a spontaneous repor... Read more
injection site pain; chills; muscle aches; fatigue; Rash on torso, arms; This is a spontaneous report from a non-contactable other hcp (patient). A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 14:30 at single dose in Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Medical history was none. Concomitant drug received within 2 weeks of vaccination included Multivitamin. The patient previously received first dose of BNT162B2 on 29Dec2020 03:15 PM at single dose in Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After 6 hrs on 19Jan2021 21:00 PM, the patient experienced injection site pain. After 12 hrs the patient experienced chills, muscle aches, fatigue in Jan2021. The patient experienced Rash on torso, arms 36 hours after in Jan2021. The outcome was Recovering. No treatment received for events. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible, information about batch number cannot be obtained.
60 2021-02-08 injection site redness, injection site swelling, skin warm left upper arm redness and swelling. She reports she got the second Pfizer COVID-19 vaccine on Mond... Read more
left upper arm redness and swelling. She reports she got the second Pfizer COVID-19 vaccine on Monday 2/1. She reports the area is red right after the vaccine. She reports she has had increased swelling, redness, warmth. She reports she did have reaction to her first vaccine with redness and swelling, but that occurred 10 days after. She reports she has had some fever and body aches that she associates with having the second vaccine. Constitutional: Negative for chills and fever. HENT: Negative for sore throat. Eyes: Negative for visual disturbance. Respiratory: Negative for cough and shortness of breath. Cardiovascular: Negative for chest pain. Gastrointestinal: Negative for abdominal pain, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Positive for joint swelling and arthralgias. Negative for back pain. Skin: Positive for color change. Negative for rash. Neurological: Negative for weakness and numbness.
60 2021-02-08 injection site mass 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 2021-02-08 hives HIVES ALL OVER
60 2021-02-08 hives The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and g... Read more
The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and globus sensation pale and tremulous. Nurse noted that she had a 4mm hive above her lip. The treatment of the reaction was: o Epinephrine: x1 Transferred to ED
60 2021-02-09 injection site pain 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 rash fatigue; low grade fever; incredible body ache; rash/looks like measles on her face; first dose 22De... Read more
fatigue; low grade fever; incredible body ache; rash/looks like measles on her face; first dose 22Dec2020, second dose 15Jan2021; first dose 22Dec2020, second dose 15Jan2021; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) on 15Jan2021 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient previously received first dose of BNT162B2 (lot number: EL0140) on 22Dec2020 at single dose for COVID-19 immunization, and experienced fatigue, low grade fever and rash. The patient received the vaccine and had minor side effects that were explained like fatigue, low grade fever, everything responded to the ibuprofen (ADVIL) a NSAID. The booster received on time on 15Jan2021 and she had a quite a challenge with it for about a week, she had the increased fatigue, really incredible body ache, the fever went away in about 2 days but fatigue lasted definitely a full week. About the 3rd day a rash started and that was not going away, she was not sure what to so about it, it became worst if she exercise, very prominent if she exercise. It's been a little over a week with symptoms of fatigue and body ache went away. The rash that she can not get rid of; It was very disturbing the rash; looks like measles on her face. Treatment included the body ache was responding to ibuprofen but fatigue she just trying to take more rest. Lab data included CBC (Full blood count) on unspecified date, that was normal. The outcome of fatigue, low grade fever, incredible body ache was recovered on unspecified date, outcome of other events was not recovered. Causality assessment from the reporter between the vaccine and events was related.
60 2021-02-09 vaccination site swelling positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous re... Read more
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer reported for herself. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL3249, exp.date May2021 on 15Jan2021 16:00 at single dose for COVID-19 immunization, via unspecified route of administration at the left arm. The patient had get earlier in January a DPT (diphtheria, pertussis, and tetanus) vaccine in the left arm. The patient had have a Pneumonia and Shingles vaccines in the last 2 years and she had no problems in past with vaccines, but stated she did get a little bit of swelling and had to put heat to the area with vaccines, but never had a fever afterwards. The patient had not medical history. Concomitant medications were not reported. No other vaccines given the same day. Since 16Jan2021, he started having symptoms, fever, cough and Diarrhea. On 17Jan2021 the patient was positive to SARS-CoV-2 test. On 19Jan2021 she received monoclonal antibody therapy. The outcome of the event was not recovered.
60 2021-02-10 injection site pain 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 2021-02-10 injection site pruritus on 2/6/2021 woke up in am with headache, chills, temperature . Symptoms continued with chills, sweat... Read more
on 2/6/2021 woke up in am with headache, chills, temperature . Symptoms continued with chills, sweating, lethargic with muscle aches and pains along with temp. Temperature returned to normal in pm on 2/7/2021. Muscle aches and pains, itchy at injection site and being tired lasted another couple of days. Feeling back to normal by 2/10/2021
60 2021-02-10 injection site swelling, injection site warmth, skin warm, injection site pain, injection site redness 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 itchy skin Evening of vaccine. Slight itching. Day after vaccine - Headache, mild "fever /chills" No Rigor, All... Read more
Evening of vaccine. Slight itching. Day after vaccine - Headache, mild "fever /chills" No Rigor, All over body aches worse than flu, fatigue.
60 2021-02-10 rash macular, redness, injection site pain The skin on my arms and legs (mostly noticed arms) looked marbled red immediately after vaccine. It... Read more
The skin on my arms and legs (mostly noticed arms) looked marbled red immediately after vaccine. It is still there but not as bad as it was initially. I googled skin conditions and it looks like Livedo reticularis. I went to my Cardiologist on 2/5/21 and he took bloodword CBC, Prothrombin Time and bloodwork was normal. Cardiologist told me to go to a dermatologist. My arm was sore also where the injection was and it was hard to lift my arm. That lasted one day. I also had aches and pains and was fatigued on 2/3/21 for 24 hours.
60 2021-02-10 skin warm pt reported mild dull headache and warm head.given water and saltines with improvement. BP slightl... Read more
pt reported mild dull headache and warm head.given water and saltines with improvement. BP slightly elevated. Pt admitted to stress. Monitored for additional 30 min. Pt felt ok to go.
60 2021-02-10 hives On Tuesday she woke up with a headache that gradually worsened. The headache was behind the right ey... Read more
On Tuesday she woke up with a headache that gradually worsened. The headache was behind the right eye, the right ear, and the teeth on the right side also hurt. Nothing helped taking Acetaminophen; Ibuprofen. She went to sleep around 4:00 am finally, and then woke up 6 hours and the headache was gone. Then you had hives located behind the right ear and down the neck, into the right shoulder. They are also in her scalp. They have now down to the tops of her legs, hips, and back and are spreading. She called her doctor who called her in some prescriptions.
60 2021-02-12 hives Urticaria on the arm
60 2021-02-14 injection site pain Injection site pain, body aches, lightheadedness, chills
60 2021-02-14 itchy skin, redness, injection site pain Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbea... Read more
Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbeat with severe pressure and chest pain. Ongoing muscle and joint pain that moves from location to location. Redness on chest and facial - cheeks.
60 2021-02-14 itchy skin 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 2021-02-14 rash papular, rash, itchy rash About 30 hours after vaccine I had bumps on my shoulder blade on left side where I received the vacc... Read more
About 30 hours after vaccine I had bumps on my shoulder blade on left side where I received the vaccine - a rash that itched. It lasted about 4 or 5 hours - I put Calamine lotion on it and that soothed it. I also experienced a little itching of eyes and a slight itching in mouth. About 9:30 pm I had a rapid heartbeat for about 30 or 40 minutes. The itching sensation continued off and on the next day but bumps weren't visible any longer. The itchy eyes continued off and on for the next day as well.
60 2021-02-14 vaccination site pain Soreness at site of injection; loose bowels; This is a spontaneous report from a contactable consume... Read more
Soreness at site of injection; loose bowels; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported for 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247) via unspecified route of administration on 26Jan2021 at 02:30 PM in left arm at single dose for COVID-19 immunization in the workplace clinic. There was no other vaccine administered in four weeks. Medical history included gluten intolerant. No Known allergies. Concomitant medication included calcium, ergocalciferol (VIT D), ibuprofen (ADVIL), multivitamin. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior to vaccination. The patient experienced soreness at site of injection and loose bowels on 27Jan2021 at 07:15 AM. No treatment was received for adverse effects. The patient was not tested for COVID post vaccination. The outcome of events was not recovered. No follow-up attempts possible. No further information expected.
60 2021-02-15 redness, itchy skin Patient was premedicated with Zyrtec 10 mg at 2:15 prior coming to her second appointment. She repo... Read more
Patient was premedicated with Zyrtec 10 mg at 2:15 prior coming to her second appointment. She reported similar symptoms from pfizer Vaccine first dose after 25 minutes of observation for the second vaccine. Reported slight itchiness and facial redness. sightly less than previous dose. The allergist on call was notified, ordered Zyrtec 10mg. Zyrtec 10 mg a/o. Initial BP 176/76 HR 64-sat 100% RA. . BP186/80 - HR 54. HR 60 BP 168/78, Observation 1:1 by RN maintained. BP prior dc 152/79 Hr 58.
60 2021-02-15 injection site pain 8:30 pm - extreme shivering, teeth chattering, extremities freezing cold, particularly the feet; sev... Read more
8:30 pm - extreme shivering, teeth chattering, extremities freezing cold, particularly the feet; severe body aches; injection site throbbing; upset stomach and a feeling of nausea. Temperature 100.2 at 8:45. Took temp every hour. By midnight temp reached 102.7. Head ache started. Couldn?t sleep on my left side because of the extreme pain around the injection site and down my left arm. Finally fell asleep around 2:30 and woke at 5:30. Fever was gone. Temp read 98.9. Body aches still present but not as severe. Arm pain had eased but head ache remained most of the day. Felt much better but just very tired.
60 2021-02-15 hives, injection site bruising, injection site discolouration, injection site redness, injection site mass The day of the vaccine there was no reaction. Day 2 I woke up with red angry lump at the injection s... Read more
The day of the vaccine there was no reaction. Day 2 I woke up with red angry lump at the injection site, about the size of a 0.50 cent piece. Later that day I had a fever of 102.5 and chills. Day 3 the redness had spread and still had the lump. Day 4 or 5 the color changed to purple and the lump had decreased. It took about a week for the lump to go away. I still have a discoloration on my arm where the vaccine was given. It looks a bruise but no pain. The whole time the area blanched well. The first dose I had on my left arm and the next day I had a small welt with redness. I am on my second round of steroids to try and get my asthma under control and had to increase my Advair to the highest dose. My doctor put me on a antibiotic as well with the second round of steroids. My asthma is a little better but not at my baseline.
60 2021-02-16 rash 2nd dose pizer 2/11; 2/12 fatigue, body aches, 2/16 rash noticed 5PM (bra line, breast, back, legs,... Read more
2nd dose pizer 2/11; 2/12 fatigue, body aches, 2/16 rash noticed 5PM (bra line, breast, back, legs, down thighs at bedtime, under arms), rash was spreading, pt put calamine lotion on rash, woke up 2/17/21 and rash is gone.
60 2021-02-17 redness, skin discolouration, vaccination site redness, vaccination site mass, vaccination site itchiness, vaccination site warmth 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 skin discolouration Toes are showing skin changes and having tingling sensation
60 2021-02-18 injection site pain Fever, pain in the arm where I got the shot. nauseated
60 2021-02-18 hives Hives on the neck, breast and torso .
60 2021-02-20 pain of skin Left shoulder has periodic pain and stinging as if someone with a heavy hand is giving me an injecti... Read more
Left shoulder has periodic pain and stinging as if someone with a heavy hand is giving me an injection now. The pain wakes me up at night. Sometimes in the day I feel the pain level at about a 6.
60 2021-02-21 vaccination site swelling Large red bump 2 inches below vaccination site. Seems to be getting bigger.
60 2021-02-22 rash, itchy rash, rash with redness Round rash the size of a 50 cents coin. Itchy and red. The area turns white when I lift my arm.
60 2021-02-23 injection site pain, redness, injection site swelling The vaccine was not injected into the muscle as prescribed. The nurse pinched up the fat on my arm w... Read more
The vaccine was not injected into the muscle as prescribed. The nurse pinched up the fat on my arm with a short needle. My upper arm swelled almost to the size of a baseball and was red and painful for over one week. I think it was administered SQ although intended to be IM. I am a nurse and thought to myself at the time of injection that the proper technique for administering the shot was not followed, but thought perhaps I could be wrong and the extra swelling might be normal with the second injection. My first injection was in left arm and did not swell and was only sore for a few days. If administered SQ, will the vaccine dose be effective?
60 2021-02-23 injection site pain Other than mild soreness at the injection site she experienced no adverse reactions during the first... Read more
Other than mild soreness at the injection site she experienced no adverse reactions during the first 24 hours post-vaccine. On the second day after vaccination she developed chills without fever followed by the appearance of rhinorrhea and sinus headache that persisted for about one week. As she has a past history of genital herpes and this resembled her prodrome for recurrence she self-administered valacyclovir for several days. On the eighth day after vaccination she noted mild hand tingling. The following morning she awoke with numbness and hyperesthesia of the left shin that is still present.There was no persistent tingling and no pins and needles sensation
60 2021-02-23 itchy skin, rash with redness, redness Pt reported slight tongue "tingling" and also has a small patch of flat erythematous area on her ski... Read more
Pt reported slight tongue "tingling" and also has a small patch of flat erythematous area on her skin about 8 minutes after the vaccine was administered. She does report the reddened area is itchy. She denies SOB, denies airway tightness, denies chest pain. Her vitals at 1356 hours are a HR of 66, BP of 139/74, RR of 18, Sats 100%, RR 16. Pt took a PO benadryl at 1347 hours per her request as she had already declined further EMS care (ALS and ambulance declined). Her Sxs resolved by 1356 hours. She stayed a few more minutes to be sure her symptoms were completely resolved and left POV at 1407 hours. She will follow up with her physician as soon as she leaves. She has been notified that her symptoms could return.
60 2021-02-23 rash, itchy rash I had the shingle injection in between the two covid injections. I've had a itchy rash for 6 weeks ... Read more
I had the shingle injection in between the two covid injections. I've had a itchy rash for 6 weeks on my legs and torso. Some raised welts and some regular rash. Nothing over the counter seems to help much.
60 2021-02-23 skin burning sensation Felt burning towards the ears and cheeks and some numbness, reported not having any difficulty brea... Read more
Felt burning towards the ears and cheeks and some numbness, reported not having any difficulty breathing but felt like she had to take off her mask to get "air", slight numbness in the arms and felt flushed.
60 2021-02-23 hives, skin discolouration, injection site pain 2/9: redness and blue color and pain around the shot site 2/13: fever 101F, body ache, headache, tir... Read more
2/9: redness and blue color and pain around the shot site 2/13: fever 101F, body ache, headache, tiredness, - Tylenol every 5 hours 2/14: fever 99 F, body ache, headache, tiredness, hives on chest, stomach, back, arms, - Tylenol every 6 hours 2/15: no fever, hives fading out 2/16: tiredness, hives cleared up
60 2021-02-24 redness 1010 pt c/o eyes draining clear fluid, generalized tingling, redness Dr notified and assessed order ... Read more
1010 pt c/o eyes draining clear fluid, generalized tingling, redness Dr notified and assessed order received to administer po benadryl 25 mg po 1030 symptoms resolving continued to monitor for additional 30 min. 1100 pt stable and symptoms resolved left premises this time.
60 2021-02-24 itchy skin, rash, rash macular itchy, chickenpox type rash on armpit, back, and trunk
60 2021-02-24 rash 10 min. After shot developed rash to chest, torso. On 4th day developed SOB, chest pain and fatigue.
60 2021-02-25 injection site pruritus, rash, itchy skin, injection site redness Itchiness and Rash: Multiple body areas: between and under breasts, lower back area, under arms. ... Read more
Itchiness and Rash: Multiple body areas: between and under breasts, lower back area, under arms. It was also on my left arm around the injection site but that has gone away. Date of 1st dose: 1/8/2021 - ELO140 Date of 2nd dose: 1/29/2021 - EJ1686
60 2021-02-25 itchy skin 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 2021-02-26 rash, itchy rash While in observation area, patient reported to EMT a rash and itchiness in abdominal area. EMT notif... Read more
While in observation area, patient reported to EMT a rash and itchiness in abdominal area. EMT notified lead nurse on site. EMT assessed patient and reported blood pressure 142/90 mmHg, regular pulse 60 bpm, and respirations 16 breaths per minute. Patient denied difficulty breathing, difficulty swallowing, and chest pain. Patient revealed history of allergies to unspecified medications. Patient offered diphendyramine. Patient refused diphenhydramine. Patient advised to wait 15 minutes for further observation. Lead nurse assessed patient. Patient reported decreased itchiness and denied difficulty breathing, difficulty swallowing, and chest pain. Patient advised to seek emergency care if symptoms progress. Patient left observation area with steady gait.
60 2021-02-26 rash, hives Pfizer-BioNTech COVID-19 Vaccine EUA Rash/hives, 2 Benadryl at 7:30P
60 2021-02-27 rash papular, rash Rash on neck last for one week. After one week, small bumps still remain 10 days later. Bumps are fo... Read more
Rash on neck last for one week. After one week, small bumps still remain 10 days later. Bumps are focused vertically from chin
60 2021-02-28 itchy skin itching to head, face, neck, arms, chest, back 20 minutes after administration
60 2021-02-28 vaccination site swelling, vaccination site redness swelling at the site; redness at the site; This is a spontaneous report from a contactable consumer ... Read more
swelling at the site; redness at the site; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: EU9899), via an unspecified route of administration in the left arm on 30Dec2020 at 15:00 as a single dose for COVID-19 immunisation. Medical history included anemia, diabetes mellitus, blood cholesterol abnormal, blood pressure abnormal, and low FE. The patient had no additional vaccine/s administered on the same date as BNT162B2, had no prior vaccinations within four weeks, and had no family medical history. Concomitant medications included liraglutide (VICTOZA; taking for 8 years), labetalol (taking for 20 years), diltiazem (CD taking 20 years), valsartan (DIOVAN; taking for 20 years), rosuvastatin (taking for 10 years), metformin (taking for 20 years), aspirin [acetylsalicylic acid] (taking for 10 years), and iron; all are ongoing. On 30Dec2020, the patient experienced swelling at the site and redness at the site. The patient stated that after the first dose, she noticed a little bit of swelling and redness at the site that went away in 48 hours. She had no relevant tests done. The events did not require any visit to a physician or to the ER. Outcome of the events was recovered.
60 2021-03-01 redness, skin warm 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 2021-03-01 redness I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I ... Read more
I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I was getting some sputum or phlegm coming up,, no cough, on short of breath no nasal discharge. During the night I woke up because the phlegm was much worse and abundant I wanted to sleep so at first was swallowing it, then it was so much that I got up and went to the bathroom. That is when I noticed that the palms of my hands were scarlet red. on both hands and not on the wrists or any where else. by morning it was gone but I did have diarrhea and still a cold mild nausea feeling in my stomach. Yesterday , 3 days later, still had diarrhea and nausea and was tired,,symptoms are not severe, but since these are not typical symptoms for me. I figured they will go away, but also I figured that I should communicate the reaction . I am scheduled for my 2nd shot in 3 weeks,
60 2021-03-02 injection site pruritus, injection site redness, injection site swelling Metallic taste in mouth that dissipated after about an hour, redness/swelling at injection site and ... Read more
Metallic taste in mouth that dissipated after about an hour, redness/swelling at injection site and itching that persisted for 3-4 days.
60 2021-03-02 itchy rash, rash with redness 8 days later got Covid arm, itchy red rash on arm
60 2021-03-03 shingles Shingles erupted on right hip/buttock
60 2021-03-04 bruising Pfizer COVID vaccine. Bruise on LEFT HAND of the left arm where I received the shot within 1 hour.
60 2021-03-04 injection site pain 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 rash macular COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient dev... Read more
COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD
60 2021-03-04 itchy rash, rash with redness 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 2021-03-06 rash with redness, itchy rash, rash Four days after vaccination my trunk was covered with a red rash that was slightly itchy. The next d... Read more
Four days after vaccination my trunk was covered with a red rash that was slightly itchy. The next day it spread partly down my arms and legs. On day 6 I had malaise and fatigue and lessening of rash.
60 2021-03-07 redness, skin warm 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 redness left arm became red and tender 2 days after the shot- and has continued for a total of 3 days withou... Read more
left arm became red and tender 2 days after the shot- and has continued for a total of 3 days without change
60 2021-03-07 injection site discomfort Almost immediate discomfort at injection site, followed by sore shoulder (left) and neck pain as wel... Read more
Almost immediate discomfort at injection site, followed by sore shoulder (left) and neck pain as well as headache for 24 hours. One week later, severe joint pain for 48 hours.
60 2021-03-07 itchy rash, rash 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 injection site pain Injection site pain, muscle pain, could not raise arm up high, chills, whole body ached, joints hur... Read more
Injection site pain, muscle pain, could not raise arm up high, chills, whole body ached, joints hurt, weak, mild consistent headache, nausea, skin sensitivity, feeling like a bad case of the flu for 30 hours. Getting better by Sunday evening. Still not 100% as of Tuesday. Slight headache comes and goes like a sinus infection would feel like.
60 2021-03-08 injection site reaction This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier t... Read more
This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier today when she says she felt immediately a flushing of her left arm where she had received the vaccination and then some tingling and abruptly followed with difficulty swallowing tongue enlargement, and feeling like she had to "search for my air". This required her to turn her head leftward to assist in her breathing. She has no associated pruritus. She was given an intramuscular injection of epinephrine at the clinic where she received the vaccination and EMS was activated. She did not demonstrate any changes in her phonation or signs of stridor and there was no wheezing or signs of facial or oral swelling on arrival of paramedics. She received additional intramuscular injection of epinephrine and IV Benadryl and Solu-Medrol at that time followed by an albuterol inhalation treatment and transported here as a medical alert. She reports the symptoms are similar to what she is experienced with multiple bee sting allergic reactions in the past. She is never required intubation. She never develops any facial swelling or urticaria.
60 2021-03-08 itchy skin Facial swelling and total body itching
60 2021-03-08 vaccination site pain Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 60... Read more
Soreness at injection site; 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: EL9265, via an unspecified route of administration, in the right arm, on01Feb2021 11:30 at SINGLE DOSE for covid-19 immunization. Medical history included diabetes, high cholesterol, high blood pressure and penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced soreness at injection site on 01Feb2021 11:30. The outcome of event was recovered. No follow-up attempts possible. No further information expected.
60 2021-03-09 injection site pain mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after in... Read more
mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after injection lasting 2 days. Headache, nausea and weakness day after vaccination lasting 24 hours.
60 2021-03-09 injection site swelling, injection site pain On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3... Read more
On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3, chills, body aches and weakness On day 4 after second dose had severe back pain, painful to walk, despite taking Motrin. Went to doctor and had MRI done. Then by early February started having insomnia, hard time falling asleep and staying asleep . I feel the second dose of vaccine might have caused my immune system to become over active. The back is now ok after rest and physical therapy but the insomnia still persist.
60 2021-03-09 itchy skin, redness Within 15 minutes after 2nd COVID-19 mRNA vaccination (Pfizer) today, patient reported itching of le... Read more
Within 15 minutes after 2nd COVID-19 mRNA vaccination (Pfizer) today, patient reported itching of left forearm (vaccine administered in left deltoid), which then also started in right arm and upper back. Slight redness noted on left forearm where patient had been scratching but no visible hives or rash. Patient denied any difficulty breathing, shortness of breath, throat tightness or itching. Diphenhydramine 25mg PO x1 dose administered. A few minutes after diphenhydramine administration, patient reported that her eyes had become itchy. 20 minutes after diphenhydramine dose, patient denied any worsening of symptoms, reported lessened itching and opted to leave clinic.
60 2021-03-09 itchy skin sever headache itching over entire torso both began about an hour after injection. Lasted through th... Read more
sever headache itching over entire torso both began about an hour after injection. Lasted through the evening and night Took Tylenol
60 2021-03-09 rash with redness, rash papular, rash raised, red rash bilateral hands from inside of thumbs to mid-forarm. provided 50mg of diphenhydram... Read more
raised, red rash bilateral hands from inside of thumbs to mid-forarm. provided 50mg of diphenhydramine. observed patient for additional 30 minutes. rash decreased in severity and there were no other symptoms (difficulty breathing, increased heart rate, etc)
60 2021-03-09 rash with redness, itchy rash Vaccination was a 7:45 am Monday. On Tuesday at mid morning I started showing an allergic reaction.... Read more
Vaccination was a 7:45 am Monday. On Tuesday at mid morning I started showing an allergic reaction. Itchy red spots all over head, ears and neck, some on lower part of body. Swollen lip. Took two benadryl at 1:45 am Wednesday . This helped to ease the itching. Had a headache so on Wednesday morning I took two Tylenol and made a Dr. appt. Also was weak and faintish on Wednesday when I got up. Dr's said to keep taking anti-histamines and report to ER if tongue or throat starts to swell.
60 2021-03-09 rash 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 2021-03-09 skin peeling, rash, itchy rash, rash with redness, rash papular burning itchy red bumpy rash started on left elbow, then spread to right elbow. Went to dermatologi... Read more
burning itchy red bumpy rash started on left elbow, then spread to right elbow. Went to dermatologist on 2/24 for biopsy (gluten rash, psoriasis) and was prescribed Clobetasol 2x day. Rash dried up with skin flaking and peeling in about 5 days. Second vaccine received 3/4, no rash as of 3/10
60 2021-03-09 vaccination site pain Fever ranging from 100 to 100.9; Chills; Headache; Soreness at site of injection; This is a spontane... Read more
Fever ranging from 100 to 100.9; Chills; Headache; Soreness at site of injection; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249), via an unspecified route of administration in left arm, on 05Feb2021 at 12:30 PM, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231) on 13Jan2021 at 01:45 PM for COVID-19 immunization (in left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 06Feb2021 at 02:00 AM, the patient experienced fever ranging from 100 to 100.9 accompanied by chills and moderate headache as well. Fever subsided by the morning of 07Feb2021 and headache was mild by then. The patient also experienced soreness at site of injection on 06Feb2021 at 02:00 AM only if she touches it. No treatment was administered for the adverse events. The patient has not been tested for COVID-19 post vaccination. The patient was recovering from the events.
60 2021-03-10 injection site pain, itchy rash Itchy rash looks like mosquito bites on legs, stomach and arms; soreness at injection site, tirednes... Read more
Itchy rash looks like mosquito bites on legs, stomach and arms; soreness at injection site, tiredness
60 2021-03-10 rash Rash around neck area
60 2021-03-10 hives, rash On March 6, I experienced swelling of the face, hands, throat accompanied by hives/rash over body.
60 2021-03-11 injection site pain Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started aro... Read more
Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started around 1 pm March 8 and subsided by 8 am March 9
60 2021-03-11 itchy skin Itching, coughing, wheezing,
60 2021-03-11 hives, itchy skin Patient was receiving an IVIG infusion at the time of reaction. Patient has had infusion many times... Read more
Patient was receiving an IVIG infusion at the time of reaction. Patient has had infusion many times in the past with no reaction, so we are possibly attributing the reaction to her recent COVID vaccine. Severe hives/boils from neck to knees Itching IV methylprednisolone was administered in the home to control reaction. Her MD prescribed famotidine and loratadine to assist with relieving her symptoms.
60 2021-03-12 itchy skin, hives whole body sever itching. Scratched shin raw, back had hives, abdomen continues to sporadically itc... Read more
whole body sever itching. Scratched shin raw, back had hives, abdomen continues to sporadically itch. Never experienced itching of this nature this before. MUCH BETTER, but not fully resolved. (My Mother had same response to her second Moderna COVID19)
60 2021-03-13 redness I have a swollen uvula with blood red spot on the side. It is hard to swallow and it burns. I will ... Read more
I have a swollen uvula with blood red spot on the side. It is hard to swallow and it burns. I will call my doctor tomorrow morning.
60 2021-03-13 injection site pain, injection site redness, injection site rash red rash around injection site soreness at injection site had bump on injection site body aches head... Read more
red rash around injection site soreness at injection site had bump on injection site body aches headache
60 2021-03-13 injection site pain, itchy skin Burning sensation at injection site, felt itching in ears when administered. Felt sore since vaccine... Read more
Burning sensation at injection site, felt itching in ears when administered. Felt sore since vaccine was administered. Today, 03/14, woke up feeling very sore and around 11:45am I began to feel chills, body aches, headache and fever.
60 2021-03-13 injection site pain INJ. PAIN 3/11/2021 TIREDNESS 3/12 &13/2021 HEADACHE 3/11 & 12/ 2021 MUSCLE PAIN 3/11 & 12/2021 C... Read more
INJ. PAIN 3/11/2021 TIREDNESS 3/12 &13/2021 HEADACHE 3/11 & 12/ 2021 MUSCLE PAIN 3/11 & 12/2021 CHILLS 3/12 & 13/2021 JOINT PAIN 3/11/12/13/2021 FEVER 3/12/13/2021 102.5 & 100.2 FEELING UNWELL 3/12/13/2021 I JUST KEPT TAKING TYLENOL TILL I FELT BETTER. I AM FINE TODAY. 3/14/2021
60 2021-03-13 injection site pain Extreme energy within 30 minutes of injection Followed about 2 hours later by extreme fatigue (slep... Read more
Extreme energy within 30 minutes of injection Followed about 2 hours later by extreme fatigue (slept over 3 hours between 11am and 3pm) Severe pain at the injection site and muscles surrounding it (approx. 8pm) continuous as of this report (3/14/21 12:45am) Pain in the lower left jaw (approx 9pm) continuous as of this report (3/14/21 12:45am)
60 2021-03-13 skin peeling, injection site pain, injection site rash 2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:... Read more
2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves. Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore. Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone. No headache
60 2021-03-14 itchy skin Left eye began watering, itching, swelling. Itching under left breast.
60 2021-03-14 rash papular, rash with redness Within 30-40 mins, I had a raised red mark starting at the base of my throat running up to my left ... Read more
Within 30-40 mins, I had a raised red mark starting at the base of my throat running up to my left nostril. There was a lighter red mark on the right side that stopped just above my chin. There was no burning, itching or soreness associated just the raised red marking. It started to dissipate within 2 hours
60 2021-03-14 vaccination site bruising, vaccination site warmth, vaccination site redness Injection site warm, raised, and red; Injection site warm, raised, and red; Left arm felt bruised af... Read more
Injection site warm, raised, and red; Injection site warm, raised, and red; Left arm felt bruised after she got the injection; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL9262, first dose) solution for injection intramuscular in the left arm on 08Feb2021 at 12:00 (at the age of 60-years-old) at single dose for COVID-19 vaccination. Medical history included obesity, arrhythmia (that was fairly under control, and was not life threatening) and palpitations (palpitations from time to time, but this medication did not cause that). Concomitant medications included escitalopram oxalate (LEXAPRO) and lisinopril. Historical vaccine included flu vaccine in Oct2020 and experienced bruised after the injection. After the vaccination, the patient experienced injection site warm, raised, and red on 08Feb2021. The patient experienced left arm felt bruised after she got the injection in Feb2021. The patient has had no treatment for her arm yet. The outcome of the events injection site warm, raised, and red and left arm felt bruised after injection was unknown.
60 2021-03-15 redness 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 2021-03-15 haematoma Immediately after vaccination, hematoma started to form. Ice was applied to affected area
60 2021-03-15 injection site pain About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hou... Read more
About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hours having bouts of diarrhea every 5 to 10 minutes along with chills and feeling hot and abdominal pain. This morning on the 16 of March I feel okay with some fatigue and sore right shoulder at injection site.
60 2021-03-15 itchy skin 3/12 ? Got vaccine at 1:40 pm and within about 1-2 minutes, I felt a sensation of heat in my throat ... Read more
3/12 ? Got vaccine at 1:40 pm and within about 1-2 minutes, I felt a sensation of heat in my throat and upper chest. It got a bit worse and then improved over the next few hours. I also experienced a scratchy/itchy sensation in my throat and a slightly itchy feeling on the skin of my neck and upper chest. No wheezing or swelling. Took 25 mg Benadryl at bedtime. 3/13 ? Sensations continued, still fairly mild, but with occasional tingling on lips in addition to other symptoms. Took 25 mg Benadryl at bedtime. 3/14 ? Feeling about the same; still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime. 3/15? Symptoms continue to improve, but I?m still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime.
60 2021-03-15 rash Allergic reaction to COVID-19 vaccine (rash on stomach - left side) Began 03/08/2021 cleared up and ... Read more
Allergic reaction to COVID-19 vaccine (rash on stomach - left side) Began 03/08/2021 cleared up and then reoccurred 03/11/2021 still evident 03/16/2021
60 2021-03-16 redness, itchy skin 60 yo woman who 3-5 minutes post vaccination developed facial itching and erythema, initially in her... Read more
60 yo woman who 3-5 minutes post vaccination developed facial itching and erythema, initially in her eyes and nose. Administered 50 mg diphenhydramine PO. In the minutes thereafter, the pruritis spread to the upper lip, then face and scalp, and became more generalized (but mild) on limbs. She also reported a "dry throat" sensation, but denies throat tightness or itching and did not have any respiratory compromise for the hour that she remained under observation. Symptoms subsided and patient left the facility. Followed up with her later by phone to inform her that her immediate allergic reaction was a contraindication to her receiving the second Pfizer COVID-19 vaccine and that she should not return for a second appointment. Advised that she seek allergist consultation given her history of multiple allergies, and to determine whether there was a common substrate for any of them. Said that she could possibly consider the Johnson&Johnson vaccine thereafter, if she did not have any known allergies to components of it.
60 2021-03-16 haematoma Hematoma to left arm. Metallic taste. Numbness in face and tongue.
60 2021-03-16 injection site pain Dizzyness, nausea, severe headache, painful arm, sore throat, fatigue.
60 2021-03-16 rash macular, redness, itchy rash generalized pruritic rash and redness, patient describes symptoms as "red and blotchy" Patient takin... Read more
generalized pruritic rash and redness, patient describes symptoms as "red and blotchy" Patient taking Benadryl to relieve symptoms. Recommended to see primary provider if symptoms worsen.
60 2021-03-16 itchy rash Slightly itchy rash on neck, face, shoulders and chest.
60 2021-03-16 rash, shingles, itchy skin 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 itchy skin Patient presented to ER around 5pm on 3/13 complaining of skin itching - this involved the forearms,... Read more
Patient presented to ER around 5pm on 3/13 complaining of skin itching - this involved the forearms, chest, under her breast, lower back and trunk. She took Claritin and used hydrocortisone cream before coming into the ER. She received diphenhydramine 50mg PO and prednisone 60mg PO in the ER. she was discharged home with prescriptions for Zyrtec 10mg, Diphenhydramine 50mg a Prednisone taper.
60 2021-03-17 rash, itchy skin I already alerted you to the rash and itching. I got a headache starting about 30 minutes after the ... Read more
I already alerted you to the rash and itching. I got a headache starting about 30 minutes after the shot. I started having what looked like bruising all along the veins in my arms and hands. Still have that. I went to the doctor and also found that I had high blood pressure and an elevated heart rate. BP 140/90 and Heart rate 85. My normal heart rate is between 55-60 and my usual blood pressure is 108/70. The doctor gave me a steroid shot. This morning, my blood pressure and heart rate were still high and I still had a headache. Then the headache stopped and I took my blood pressure and it was down to around my usual 108/70 and the heart rate was 60. So hopefully I'm starting to recover from this shot.
60 2021-03-17 rash swollen lymph nodes (felt like a lump) in neck and rash on lower lip and chin
60 2021-03-17 hives, itchy skin, redness Face begin to itch, then neck. About 20 minutes later started to notice large hives on face and nec... Read more
Face begin to itch, then neck. About 20 minutes later started to notice large hives on face and neck. Very red and itchy. Went to pharmacy to get Benedryl and pharmacist suggested to go to ER immediately. Went to ER and was evaluated and kept for observation. No swelling of tongue or difficulty breathing. Stayed for observation and given prednisone (deltasone) . Given an epi pen and instructed to take benedryl. Hives subsided. No reactions since that night. Arm a bit sore but nothing severe. Seeing an allergist next week as followup.
60 2021-03-17 vaccination site pain 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 injection site hardening, injection site bruising, injection site bleeding Date and time adverse event started: 3/18/21 1520 immediately 1707 Caller states about 2 hours ag... Read more
Date and time adverse event started: 3/18/21 1520 immediately 1707 Caller states about 2 hours ago called was given Pfizer in the Left deltoid. Felt slight pain then when needle withdrawn started bleeding. Pressure was applied for about 45 minutes dressing changed two times. now has a band aid over the area. Area is starting to bruise and the patient is getting a headache. Patient has a grape sized hard knot at the injections site. Patient using ice indirectly for 10 minutes on 10 minutes off. Caller questions if vaccine went into the blood stream will it be effective, or does the vaccine need to be placed in the muscle to have time to replicate to be effective. . Does caller need another first shot.
60 2021-03-18 injection site pain, injection site swelling, injection site inflammation Had vaccine on Tuesday, 3/9 and on Thrusday night and Friday evening , my right elbow area was very ... Read more
Had vaccine on Tuesday, 3/9 and on Thrusday night and Friday evening , my right elbow area was very sore. The pain is very localized and responded to a couple of days of ibuprophen. Started again this week and the arm is swollen/inflammed. Uncomfortable for daily activities like typing or eating. Does respond to ibuprophen. Trying to rest it and have it in sling to rest it.
60 2021-03-18 injection site pain Injection site pain, Fatigue Narrative: Other Relevant History:
60 2021-03-18 itchy skin, injection site redness, redness, injection site pruritus, injection site 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 2021-03-18 itchy skin Itching mostly on upper body, chest back, arms &neck w/o rash started on 3/11/2021 & stopped on 3/1... Read more
Itching mostly on upper body, chest back, arms &neck w/o rash started on 3/11/2021 & stopped on 3/15/2021
60 2021-03-18 psoriasis Psorisis has become active after a very long period of it been in remision
60 2021-03-19 redness, injection site nodule 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 2021-03-19 redness, skin warm, itchy skin, pain of skin Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, ... Read more
Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, violent headache, chills fevers ,dry heaves, red and hot arm developed after couple days lasted about six days spread to 4x6 inches got itchy then sore to touch. Became vague and almost disoriented, had to sleep due to overwhelming fatigue w vile headache
60 2021-03-19 injection site pain Headache, injection site pain, nausea, tiredness, joint pain
60 2021-03-19 injection site swelling swelling where shot was given and could not lift my arm for 2 days. Nausea for 2 days and really ... Read more
swelling where shot was given and could not lift my arm for 2 days. Nausea for 2 days and really tired.
60 2021-03-19 rash, itchy skin, hives 3 days after 2nd dose of Pfizer vaccine I started getting itching, rashes and hives all over. Went t... Read more
3 days after 2nd dose of Pfizer vaccine I started getting itching, rashes and hives all over. Went to bed about 10:30. Got up about 4:30 am to use bathroom, felt lightheaded and blacked out and apparently hit my head on something. Realized ears were closing up and had soreness in chest that made deep breath's difficult. Called 911 and nursing line and decided to go to Emergency Dept. Did CT scan for bumps on head and IV and gave me epinephrine and Pepcid. Was discharged with prescription for Epi Pen, Zyrtec, and Pepcid. Still have rash and hives but not as extensive, comes and goes.
60 2021-03-20 itchy skin Chills, itching, swelling of lips, itchy eyes, sore joints,
60 2021-03-21 erythema multiforme (skin lesion) Due to 4 days progressive worsen skin lesion. Lesion as erythema multiform, generalized on hand, for... Read more
Due to 4 days progressive worsen skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg; Oral ulcer; Chill; Body ache; Joint pain; Joints swelling; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (HCP). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201), via unspecified route of administration in the left arm on 17Feb2021 as single dose for COVID-19 immunization. Medical history included hyperlipidemia. The patient had no known allergies. The patient is not pregnant. There were no vaccine in four weeks. Other medications in two weeks included cholesterol med. The previously received the first dose of BNT162B2 on 26Jan2021 12:00 intramuscular at left arm (lot number: EL9262) for COVID-19 immunization. The patient was seen at urgent care on 04Mar2021 due to 4 days progressive worsened skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg from 28Feb2021 (12:00 AM). Patient presented with chill, body ache, joint pain, joints swelling and diarrhea since second dose of vaccine on 17Feb2021. She also has oral ulcer at the same time when rash started on 28Feb2021. Vital sign was stable, no shortness of breath (SOB) and no chest pain. Events resulted in Doctor or other HCP office/clinic visit. The treatment for the events included Hydroxyzine 25 mg prn. It was unknown if patient had COVID prior vaccination or if COVID tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Erythema multiforme cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
60 2021-03-21 injection site pain, injection site swelling, injection site redness, injection site warmth, injection site pruritus, injection site bruising Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injecti... Read more
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient stated started next day, reddness, used coritsone and the spot began to grow, now is red and hot to touch, but no longer painful. Thinks it may be celluilitis and is going to check with primary MD as follow up.
60 2021-03-21 injection site pain pain from vaccine site up back of neck, tingling lips and glassy eyes
60 2021-03-21 injection site pain 8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscl... Read more
8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness. Initially I noticed my knees hurting with radiating pain up into my thighs. My head hurt, particularly at the back of my skull, near my neck. My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder. I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms. She told me I could take either and alternate if I felt I needed to maximize relief. I noticed the joins in my toes and fingers were hurting. It was frightening to experience tightness in my chest and back muscles. I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted. I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get. I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse). I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding. She encouraged water and more painkiller. As the day wore on, I felt less achy and more shaky/jittery. My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy." As I write this 36 hours after my injection, my symptoms are subsiding. Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body. It isn't a fever - just an odd sensation that something is still going on.
60 2021-03-21 injection site pain 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 injection site pain Injection site pain Narrative:
60 2021-03-21 injection site pruritus, injection site pain, injection site swelling, injection site warmth Injection site hot red swollen itchy burning
60 2021-03-21 injection site swelling, injection site pain Headache, site of injection hurt, swollen injection site, slight fever and chills
60 2021-03-21 itchy skin, rash, hives 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 hives 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 2021-03-22 redness Red swollen eyes, runny nose, congestion, fatigue, and small amount of shortness of breath. Lasted a... Read more
Red swollen eyes, runny nose, congestion, fatigue, and small amount of shortness of breath. Lasted about two days
60 2021-03-22 injection site pain Severe headache 101 temp Nausea Intense pain at injection site Intense body pains
60 2021-03-22 injection site tingling At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fing... Read more
At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fingers. Pain to the back of my neck, a flush of warmth to my upper body and difficulty breathing. Felt like a truck ran over my chest. I was weak, dizzy and nauseous as well. The tingling sensation also affected both my legs. The RN took to their infirmary area and began taking my vitals. Vitals seems normal, Blood Pressure and Pulse were high. I am asthmatic but did not bring my inhaler with me. Because of my difficulty breathing, they decided to inject me with Benadryl which is all they had. After about twenty minutes, my breathing started to calm down and blood pressure began coming down as well.
60 2021-03-22 injection site pruritus, injection site pain, injection site swelling Extreme arm pain, swelling at injection site as well as intense itching. Used extra strength Tylen... Read more
Extreme arm pain, swelling at injection site as well as intense itching. Used extra strength Tylenol, store brand antihistamine and extra strength Benadryl cream.
60 2021-03-22 injection site swelling, injection site redness She started noticing about an hour and a half after she got her vaccination that the injection site ... Read more
She started noticing about an hour and a half after she got her vaccination that the injection site started turning red and her arm started swelling from her shoulder down to her hand. She has started taking Advil and icing her arm. It has improved since the evening after she received her vaccination.
60 2021-03-22 itchy skin Pt developed dyspnea, significant voice changes and pruritus. Symptoms almost completely resolved.0
60 2021-03-22 itchy rash 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 2021-03-22 rash, itchy rash Pfizer-BioNTech COVID-19 Vaccine EUA: nine and thirteen days after vaccination patient evaluated for... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: nine and thirteen days after vaccination patient evaluated for persistent, raised, pruritic rash on chest. Patient reports reaction is similar to previous allergic reactions to shrimp. Did not take any medications to treat rash prior to first evaluation. Patient denies wheezing, dyspnea, fever, chills, myalgias, arthralgias, bleeding, nausea, mouth sores, and angioedema. Vital signs within normal ranges. Patient advised to use diphenhydramine.
60 2021-03-22 rash Headache, Fever, Rash, RASH NOT AT INJECTION SITE Narrative:
60 2021-03-23 injection site pain Symptoms were minor--soreness at injection site for 2 days, loose stool the day after injection, and... Read more
Symptoms were minor--soreness at injection site for 2 days, loose stool the day after injection, and minor headache and fatigue on the day after injection through the following day (2 days after injection).
60 2021-03-23 itchy skin, rash with redness At approximately 11:05, patient, reported to her vaccinator that she had a reaction of rashes and it... Read more
At approximately 11:05, patient, reported to her vaccinator that she had a reaction of rashes and itchiness after she received the first dose of Pfizer BioNTech Covid-19 Vaccine (LOT# EN6198; exp. 06/30/2021) on 02/27/21 at 10:59 AM. Vaccinator immediately reported to lead nurse at vaccination site. Lead nurse assessed patient history. Patient reported reported itchiness on torso, scalp and left breast approximately 5 minutes after first dose. Patient offered oral diphenhydramine in observation area. Patient declined diphenhydramine. Patient went home and stated she noticed redness and rashes before going to bed. Patient reported redness and rashes extending from deltoid to elbows on both left and right arms. Patient took bendadryl to alleviate symptoms. Symptoms lasted for approximately 3 weeks. Patient also reported no reaction to prior vaccinations. Patient reported talking to her doctor after first dose. Patient advised to apply hydrocortisone cream before 2nd dose of Pfizer and to take benadryl after 2nd dose was given. At approximately 11:11 lead nurse elevated situation. Lead nurse advised to not give patient her 2nd dose of Pfizer, offer Janssen as her 2nd dose, and recommend patient to see an allergist. Patient agreed to take Janssen as her 2nd dose. Lead nurse recommended patient to see an allergist and took patient contact information to set up her appointment for Janssen as her second dose.
60 2021-03-23 itchy skin Pruritis, shortness of breath Patient to the hospital via EMS. Vitals remained stable and lungs cle... Read more
Pruritis, shortness of breath Patient to the hospital via EMS. Vitals remained stable and lungs clear. Vitals upon discharge 164/99, HR 86, oxygen saturation 98%. Patient was observed until 12:15pm and was wheeled out to her transportation service.
60 2021-03-23 shoulder injury related to vaccine administration, injection site pain She has shoulder injury related to vaccine administration with decreased range of motion of shoulder... Read more
She has shoulder injury related to vaccine administration with decreased range of motion of shoulder, pain at deltoid and pain with overhead activities that persists, albeit some improved, for 2.5 months post vaccination
60 2021-03-24 injection site pain this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400m... Read more
this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400mg ibuprofen before going to bed around 11pm. by 1 am on 3/24 I was running a fever, shivering & my inj arm was very sore/felt heavy. Took 400 more ibuprofen, fever reduced before too long. Also felt slightly nauseous during the night & into the day of 3/24. around 2 pm got a bad headache. more ibuprofen, still felt a little nauceous, tho that subsided in early a.m. 3/25. Also was coughing quite q bit most of 3/24, but that may have been due to allergy stuff. experienced some mild diarrhea on 2 occassions 3/24. Symptoms are fairly well abated by 10a.m. 3/25.
60 2021-03-24 itchy skin, rash Body aches and chills at first. On Sunday 3/21, my fever spiked to 103.7. called doctors office. Was... Read more
Body aches and chills at first. On Sunday 3/21, my fever spiked to 103.7. called doctors office. Was told to take Tylenol for fever and if it didn't drop to the walk in or ER. It finally dropped later that evening. Then the next day 3/22 i have a rash on my arm i received the vaccine in. On 3/24 it was worst. put a call back into the doctors. Said if it continues to get worst to go to the ER. I put ice and cortisone cream on it which helped take the itching away.
60 2021-03-24 itchy skin After coming into the observation post vaccination, the patient told the nurse that she was itchy. T... Read more
After coming into the observation post vaccination, the patient told the nurse that she was itchy. The nurse assessed her and did not note any hives but did see scratch marks. Soon after, the patient stated she felt hot and had a headache. She quickly noted that her throat had begun to also hurt at that time. EMT's came over to assess her, per the nurses request the EMT's at that time suggested to the patient that she be further evaluated at the hospital. She accepted the transport to the ER.
60 2021-03-24 hives, itchy skin Suddenly broke out with itchy hives inside arms and legs.
60 2021-03-25 injection site swelling Right arm biset swollen. Body aches
60 2021-03-25 itchy skin Itching from my head that progressed to my knees by early afternoon. No hives or anything else. Res... Read more
Itching from my head that progressed to my knees by early afternoon. No hives or anything else. Resolved after two doses of benadryl about 4 hours apart. Woke up next morning feeling fine.
60 2021-03-26 redness, itchy skin 2nd dose of Pfizer COVID vaccination at 1pm. Had sudden onset itchiness, erythema, difficulty breath... Read more
2nd dose of Pfizer COVID vaccination at 1pm. Had sudden onset itchiness, erythema, difficulty breathing and lip swelling at 7pm. Brought to ED, given epipen and methylprednisolone. Monitored closely overnight, symptoms resolved by AM.
60 2021-03-26 injection site redness, injection site reaction, injection site nodule Red circle around injection site, knot at injection site
60 2021-03-26 injection site pain Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., s... Read more
Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., slept 13 hours, On March 17, woke at 10 am. Nausea, fever, chills gone, but totally exhausted with burning sensation at shot site and soreness in upper right arm. Remained in bed all day, asleep by 6 pm. Remained exhausted through March 23. Any physical activity caused shortness of breath and further tiredness. Exhaustion dissipated by March 24, 2021
60 2021-03-26 itchy skin Itchy on upper body
60 2021-03-26 rash Left leg rash. Right leg rash
60 2021-03-26 skin discolouration Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip complete... Read more
Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip completely white that lasted about 10 min. Once color returned I soon became dizzy and weak feeling in my legs followed with vomiting. I then felt a little better with mild light headedness.
60 2021-03-26 skin warm 1-After 5 minutes of taking the vaccine I started to sneeze few minutes later it pass. At about 12mi... Read more
1-After 5 minutes of taking the vaccine I started to sneeze few minutes later it pass. At about 12midnight My arm was sore and in pain and very warm to the touch 2- on Tuesday morning I was very cold and very tired . 3- Around none or so I notice my self cleaning my mouth the left side , it feel like you just where out of the Dentist , like went you anesthesia from the dentist is running out. I have feeling but it almost feel like my drooling like my saliva is out of my mouth and also my left eye felt heavy and at first very watery and the dry . My left side of my mouse feel different and I?m connately cleaning my mouth.
60 2021-03-27 injection site pain Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness... Read more
Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: vomiting-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
60 2021-03-27 injection site swelling, injection site redness 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 injection site swelling, injection site pruritus painful arm and shoulder, also bump at injection site arose and is itchy
60 2021-03-27 itchy skin, rash macular Patient walked to medical tent complaining of itchy, blotchy skin chest and hand; voice breaking; t... Read more
Patient walked to medical tent complaining of itchy, blotchy skin chest and hand; voice breaking; throat uncomfortable, shaking BP 164/74 P 111 02 97%. Epi 0.3mg IM administered transferred to EMS for hospital transfer.
60 2021-03-28 redness, itchy skin 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 injection site pain Extreme headache for 3 days weak and tired very sore arm at injection site
60 2021-03-28 itchy skin, injection site mass Very large lump that itches.
60 2021-03-28 itchy skin, hives itchy welts on legs and arms, lasting for 4-5 days after, after 2 nd dose, one left leg and arm agai... Read more
itchy welts on legs and arms, lasting for 4-5 days after, after 2 nd dose, one left leg and arm again lasting for 4-5 days, then then staring again on the 17th of March.
60 2021-03-29 redness, hives Shortness of Breath; Urticaria; Bronchospasms; Flushing; redness; This is a spontaneous report from ... Read more
Shortness of Breath; Urticaria; Bronchospasms; Flushing; redness; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot EN5318) via an unspecified route of administration in left arm on 09Mar2021 at 10:00 AM (at the age of 60-years-old) at single dose for COVID -19 immunisation. Medical history included systemic lupus, asthma, rheumatoid arthritis, thyroid cancer. She had allergies for antibiotics, pneumovax and morphine. She had taken other medications in two weeks. No other vaccine in four weeks was received. She experienced urticaria, bronchospasms, itchiness, shortness of breath, flushing/redness on 09Mar2021 at 10:15 AM. The adverse event was resulted in emergency room/department or urgent care. She was treated with IV fluids, benadryl, decadron and solumedrol. She did not have COVID prior vaccination and COVID tested post vaccination. Outcome of events was ecovering. No follow-up attempts are possible. No further information was expected.
60 2021-03-29 itchy skin, rash rash; itchiness; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregn... Read more
rash; itchiness; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration, in the right arm on 26Feb2021 at 15:45 (at the age of 60-years-old) as single dose for COVID-19 immunisation. Medical history included cardiac murmur, allergy to walnuts, and shellfish, allergy to penicillin, bilateral stenosis of ureters, and obesity; all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received unspecified concomitant drugs within 2 weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took morphine and experienced drug hypersensitivity. On 26Feb2021 at 17:00, the patient experienced rash and itchiness. The patient was given diphenhydramine (BENADRYL) as treatment for the events, rash and itchiness. The patient recovered from the events, rash and itchiness on an unknown date.
60 2021-03-30 redness, rash with redness Important to share: I had a strong case of Covid in March, 2020. No hospitalization and no need to g... Read more
Important to share: I had a strong case of Covid in March, 2020. No hospitalization and no need to go to hospital but I was very sick for three weeks. Oddly, after Covid I had odd heart pains and erratic high blood pressure. I saw a cardiologist and my heart was fine but it lasted on and off for months. I've been very well for months now. 1) The day after the shot, I felt tired and had a headache, which is expected and no big deal. The evening after the shot I experienced a lot of pain around my heart area. It was very similar to what I experienced post-Covid but more painful. It hurt enough that I went to the ER at Hospital in because of the chest pain. EKG, chest x-ray, and all blood tests were normal. 2) The next day, I fell asleep on a hammock in my backyard. I was wearing jeans and a sweater so the sun wasn't directly on me but I noticed later that the outside of my R leg and the inside of my L leg were covered in a red, lacey-looking rash. Oddly, my arms and torso had no rash. I called my Internist (Dr.) who asked me to email photos. She said it looked like an allergic reaction to the vaccine and advised me to submit info on this site and to take a benedryl. The rash was definitely where the warm sun hit me.
60 2021-03-30 redness pt. c/o of tingle on her lip & back of her throat a little redness on nose & cheeks. no shortness ... Read more
pt. c/o of tingle on her lip & back of her throat a little redness on nose & cheeks. no shortness of breath. lungs all clear & vitals BP=142/88; P=82; O2=95%. Hx= tachycardia
60 2021-03-30 injection site pain Pain at injection site, extreme back and body aches, headache, dizziness, low grade fever. Ibuprofen... Read more
Pain at injection site, extreme back and body aches, headache, dizziness, low grade fever. Ibuprofen & Acetaminophen As of 4:00pm on following day of injection, reactive symptoms still occurring...
60 2021-03-30 injection site pain Severe pain where shot was administered for 3 day. Very Bad Sinus Headache for 4 days. I still hav... Read more
Severe pain where shot was administered for 3 day. Very Bad Sinus Headache for 4 days. I still have this symptom not as severe but every time I cough I get the pain in the center of my forehead or if I bend to get something from the floor. I never had this before till I received the first shot.
60 2021-03-30 rash After developing blood blisters in my mouth and a rash on my feet & legs, I phone the Advice Nurse ... Read more
After developing blood blisters in my mouth and a rash on my feet & legs, I phone the Advice Nurse and had a phone consult with Dr. I had a blood test the following morning and recieved a call the next morning at 5:40 a.m. directing me to my local Emergency Department as my platelets measured only 16. I checked in 3/30/21 and following a new blood test showing my platelet count was down to 2, a Gastroenterologist diagnosed me with severe ITP. I then was treated with prednisoone, plasma transfusion and IGG (i think) infusion. An additional blood test showed my platelet count rose to 50. A CT scan showed no abnormalities.
60 2021-03-30 hives hives - benadryl
60 2021-03-31 injection site redness, injection site pain Fatigue- 36 hours Fever (100-102) -48 hours Chills - 48 hours Sore/red arm at injection site - 1 wee... Read more
Fatigue- 36 hours Fever (100-102) -48 hours Chills - 48 hours Sore/red arm at injection site - 1 week
60 2021-03-31 injection site pain, injection site warmth, injection site swelling I woke up the morning after my second Pfizer vaccine with severe body aches, chills, mild headache, ... Read more
I woke up the morning after my second Pfizer vaccine with severe body aches, chills, mild headache, low-grade fever, puffy injection site that felt warm to the touch and hurt. The worst of it was the whole body aches and chills, which made me feel like I have felt in the past when I have had the seasonal flu. The symptoms lasted all day, with the chills finally leaving by around 10 pm. By the following morning, so about 48 hours after the shot, I felt pretty much normal. I was told I could get these side effects, and don't think they are unusual per se, but thought it was my duty to report them for longitudinal studies.
60 2021-03-31 injection site pain Site soreness immediately following vaccine which dissipated quickly. HOWEVER, 4 days AFTER vaccine ... Read more
Site soreness immediately following vaccine which dissipated quickly. HOWEVER, 4 days AFTER vaccine experienced extreme vertigo, dizziness, nausea which required an ER visit. Side effects still lingering next day.
60 2021-03-31 injection site pruritus, injection site pain Headache chills fever upper respiratory cough, muscle aches, earache, stomach ache, pain at inject... Read more
Headache chills fever upper respiratory cough, muscle aches, earache, stomach ache, pain at injection site and itching
60 2021-03-31 itchy skin, hives Low grade fever; itchy throat and face/slight hives, cold compress; few hours Tues: fatigue; Wed: ok... Read more
Low grade fever; itchy throat and face/slight hives, cold compress; few hours Tues: fatigue; Wed: okay; Thurs: all day diarrhea; Fri: morning diarrhea; Sat. okay; Sun and Monday; Sneezing and runny nose; Tues: runny nose
60 2021-03-31 rash Medical Information Potential AE; rash on her lower stomach area; This is a spontaneous report from ... Read more
Medical Information Potential AE; rash on her lower stomach area; This is a spontaneous report from a contactable consumer (patient). A 60 year old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on 19Mar2021 as a single dose for COVID-19 Immunization. The patient's medical history and concomitant medication were not reported. It was reported that Yesterday morning patient developed a rash on her lower stomach area. Patient wanted to know she could treat this at home with cortaid or anti itch cream or should she see her family physician and get an antibiotic. The outcome for the events was unknown. Information on the lot number and batch number has been requested.
60 2021-04-01 shingles, blister The day after the vaccination, there was pain on my left side (my vaccine shot was in my right arm).... Read more
The day after the vaccination, there was pain on my left side (my vaccine shot was in my right arm). By Saturday 3/27/21 (day 4), a localized rash appeared on my left side (midriff area) which looked like herpes blisters. The area was sensitive to touch and painful. The pain had spread to my left back area. Started 1000 mg Valacyclovir 3 times a day on 3/30/21, after I saw the doctor and she confirmed it was probably shingles. The rash and sensitivity/pain are still present today, 4/2/21, on day 10 after the vaccine.
60 2021-04-01 shingles Shingles on my scalp
60 2021-04-01 injection site bruising Brusing at injection site on day of shot, dizziness 3 days after shot
60 2021-04-01 injection site pain Left arm- extremely sore shoulder to elbow, foggy headache, chills, fever blisters, sluggish.
60 2021-04-01 injection site pain Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Ch... Read more
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: Patient reported vitals from ER BP=107/70, Liver tests were off due to dehydrated per ER , had fever ,sweats then chills and Headache followed by fatigue for a few days. Patient did notify her PCP
60 2021-04-01 injection site rash Left forearm rash. Using Tylenol, topical numbing cream. See previous vaccine adverse event recorded... Read more
Left forearm rash. Using Tylenol, topical numbing cream. See previous vaccine adverse event recorded this AM. No changes. Advised to contact PCP if rash is getting worse.
60 2021-04-01 injection site swelling, injection site redness Fever of 102.5, swelling in left arm with redness exceeding three inches by 2 inches in left arm, ch... Read more
Fever of 102.5, swelling in left arm with redness exceeding three inches by 2 inches in left arm, chills, extreme fatigue
60 2021-04-01 injection site swelling Lump at the injection site the size of a plum and pain in the area. Slowly subsided, but took 1 wee... Read more
Lump at the injection site the size of a plum and pain in the area. Slowly subsided, but took 1 week to no longer have a visible lump or pain and soreness.
60 2021-04-02 redness Flushing /redness of face starting 50 minutes after vaccine Hot feeling of face & mouth & slight ti... Read more
Flushing /redness of face starting 50 minutes after vaccine Hot feeling of face & mouth & slight tingling in mouth that lasted 3-4 hours Low grade fever 99.4 about 3-4 hours after vaccine All resolved within 5-6 hours
60 2021-04-02 itchy rash, rash It started as small itchy bumps on my right arm at elbow. Progressed to welps and finally a rash ove... Read more
It started as small itchy bumps on my right arm at elbow. Progressed to welps and finally a rash over my right arm. It never moved beyond the arm. I googled when I realized it was my vaccine arm. I have had allergic reactions before, but this was limited to my right arm. Found a condition called COVID Arm.
60 2021-04-02 rash, rash macular rash on thighs, abdomen and back. Large red spots. do not itch. do not break open. just spot... Read more
rash on thighs, abdomen and back. Large red spots. do not itch. do not break open. just spots. increased lethargy
60 2021-04-02 vaccination site pain Sore left arm at injection site; Tingling feeling on forehead; Slight headache; neck pain; This is a... Read more
Sore left arm at injection site; Tingling feeling on forehead; Slight headache; neck pain; This is a spontaneous report from a contactable Pharmacist. A 60-years-old female patient received BNT162B2 ( BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247) first dose via an unspecified route of administration, administered in left arm on 18Feb2021 9:15 as single dose for COVID-19 immunization. Vaccination administered facility Workplace clinic. The patient medical history included Osteoporosis; irritable bowl syndrome. The patient concomitant medications included : Citracal; Centrum; Vit D (ergocalciferol); Colace; Evening Primrose (oenothera biennis), ascorbic acid, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, chromium picolinate, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium borate, magnesium oxide, manganese sulfate, nickel sulfate, nicotinamide, panax ginseng root, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium metavanadate, sodium molybdate, sodium selenate, stannous chloride, thiamine mononitrate, tocopheryl acetate, zinc oxide (CENTRUM ENERGY). On 18Feb2021 10:00 patient experienced with sore left arm at injection site (vaccination site pain), tingling feeling on forehead, slight headache, and sore neck on left side. The outcome of the event was recovering. Follow-up information was received on (25-MAR-2021): No new medically significant information was received on this case.
60 2021-04-03 injection site mass, injection site warmth, injection site pruritus, injection site redness early AM, pea size lump at injection site, itching which grew to a date size lump with reddening and... Read more
early AM, pea size lump at injection site, itching which grew to a date size lump with reddening and hot to touch by 5PM same day. lump and redness grew larger over next few days, with itching sensation. red mark the size of a grapefruit (5"). no pain in arm at injection site, yet swelling/lump and very large red covid burn.
60 2021-04-03 itchy skin Day 1 - within 5 minutes I felt extremely sleepy and my eyelids were heavy 15 - 2... Read more
Day 1 - within 5 minutes I felt extremely sleepy and my eyelids were heavy 15 - 20 minutes of receiving the vaccine, I was experiencing itchiness - like hives or from allergic reaction (I had them previously from allergy test reactions and allergic reactions). It was generally all over, but then I started itching under my arms. At that point, we informed the medical person who was monitoring our waiting section. He asked if I had any Benadryl, and I responded that I did. I took 12 ml (?) of Benadryl liquid and the effects subsided somewhat. I slept and when I woke up, I was itchy again and my stomach was cramping. I took more Benadryl and over the next 5 days got better.
60 2021-04-03 rash Rash over the body, after both 1st and 2nd Covid-19 vaccineations
60 2021-04-03 rash chills; body aches; under arm/neck/torso/inner thigh rash; diarrhea; This is a spontaneous report fr... Read more
chills; body aches; under arm/neck/torso/inner thigh rash; diarrhea; This is a spontaneous report from a contactable consumer (patient reported herself) reported in response to non-HCP letter sent in cross-referenced case. A 60-Year-old female patient received second dose of BNT162B2 (COVID 19, Pfizer/BioNTech, Formulation: Solution for injection, Lot number: EL3247, Expiration Date: May2021) via an unspecified route of administration on 16Feb2021 02:45 PM at single dose to her left arm for Covid-19 immunization. Facility type vaccine: Workplace clinic. The patient's medical history was not reported. Known allergies included gluten intolerant. Historical vaccine details included: product: COVID Pfizer, vaccine date: 26Jan2021, lot number: EL3247, vaccine location: arm left, Expiration Date: May2021, time the vaccination was given: 14:24 (24hour clock), anatomical location of administration of Pfizer vaccine considered as suspect: arm left, events: soreness at site of injection and loose bowels; fine now; did not receive any treatment. Concomitant medications included lisinopril, MULTIVITAMIN, ongoing ergocalciferol (VIT D), ongoing calcium and ibuprofen (ADVIL) from an unspecified date to an unspecified date. Covid was not tested prior or post vaccination. On 17Feb2021 01:45 PM, the patient experienced chills, body aches, under arm/neck/torso/inner thigh rash and diarrhea. Outcome of the events was not recovered.
60 2021-04-04 redness 12:35PM STATES SHE IS LIGHT HEADED; FOREARMS RED - PLACED ON FLOOR WITH FEET ELEVATED.12:40 MOVED TO... Read more
12:35PM STATES SHE IS LIGHT HEADED; FOREARMS RED - PLACED ON FLOOR WITH FEET ELEVATED.12:40 MOVED TO COT PER WHEELCHAIR. A/O, PINK, W/D, RESP REG WITH EASE. 12:48 'FEELS BETTER'. 1:50PM FEELS BETTER - HUSBAND HERE TO DRIVE PT HOME. NO REDNESS TO ARMS; NO ACUTE OR OBVIOUS DISTRESS NOTED.
60 2021-04-04 injection site pruritus, injection site redness Redness around injection site, very itchy
60 2021-04-04 rash with redness, blister, skin burning sensation, skin irritation, rash Pfizer-BioNTech COVID-19 Vaccine EUA I received my 2nd shot on 3/26 in my left arm. I had no reacti... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA I received my 2nd shot on 3/26 in my left arm. I had no reaction to either shot. On Thursday, 4/1 I got a rash on my lower right arm. I had just used a Brillo pad to scrub a pot. Although I have used them many times with no problem, I thought maybe the soap got on my arm and irritated it and didn't think anything of it. As the day went on, the rash got more red, burned, and started to form tiny blisters. I had Clobetasol Ointment home and put that on it. The blisters started healing but the rash is still red. On Sunday, I felt an irritation on the same arm but near my arm pit. When I got home, I found a similar rash (2 patches). This burned just like the other rash. I put the same ointment on. Now I thought I better research because it seemed odd. I read about other rashes but they were on the same injection site arm. I thought I better report this just in case it is from the shot. The original first patch is still red but does not burn.
60 2021-04-04 rash papular, shingles, hives Started feeling unusual burning in right arm ( opposite from vaccine side), from wrist to elbow then... Read more
Started feeling unusual burning in right arm ( opposite from vaccine side), from wrist to elbow then elbow to shoulder. Attributed it to tennis elbow from strenuous hitting, then got raised welts like hives following evening on right shoulder. Rash appeared and I started to suspect shingles. ( have never had before) saw doctor on 3/30/2021 and got shingles diagnosis. I believe it is due to the vaccine and have spoken to multiple medical professionals that believe there is a connection. I have had racing heartbeat, numbness on right side of face, severe pain in right ear.
60 2021-04-04 rash, itchy skin Itchy skin followed by rash with bumps and itching under both arms. The rash has not gotten better i... Read more
Itchy skin followed by rash with bumps and itching under both arms. The rash has not gotten better in fact it's worse now then it was when injection was first received.
60 2021-04-04 rash, rash with redness, injection site mass, rash vesicular, skin peeling, itchy skin Itchy hand, wrist and ankles, small lumps 50+ size of pea or smaller started 6 days after vaccinatio... Read more
Itchy hand, wrist and ankles, small lumps 50+ size of pea or smaller started 6 days after vaccination. Continued 4 more days (today) as they turned red, blistery, bubbled, popped, skin pealed on the larger areas (less than the size of a dime). Moved up to shoulders, and on legs up to thighs. Possible one on tongue. Antihistamine will take down the itchiness although initially adding Benadryl too.
60 2021-04-05 injection site pain Received shot on Friday afternoon. On Saturday morning had sore arm at injection site. Then develo... Read more
Received shot on Friday afternoon. On Saturday morning had sore arm at injection site. Then developed very achy shoulder, with ache spreading up neck and down back on left side. Some fatigue as well. Aches dissipated after a couple of hours, but fatigue continued and worsened on Sunday and continued into Monday. Also on Monday, woke up nauseated, and it continued, on and off, throughout the day until bedtime. Nausea gone on Tuesday, but still a bit more tired than usual.
60 2021-04-05 itchy skin Facial flushing, neck flushing, throat itching, skin itching, lips tingling, body hot
60 2021-04-05 rash, itchy rash Small itchy rashes but not at the site of the the shot in upper right arm. Rash started two days af... Read more
Small itchy rashes but not at the site of the the shot in upper right arm. Rash started two days after 1st shot given on right side upper arm. Rashes only on left side of body on right thigh, right wrist and right side of face. No other side effects. A few smaller spots popping up four days after shot on right thigh. Rashes are small and one the wrist is very itchy - mild rashes. No treatment from healthcare provided was needed.
60 2021-04-05 hives, rash 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 2021-04-05 hives patient came back to the store with hives, administered 10ml diphenhydramine liquid
60 2021-04-06 dry skin, skin warm, rash, injection site rash, redness 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 redness, rash facial flushing - red, warm rash to face
60 2021-04-06 redness, skin warm About 45 minutes after shot my face got very hot and bright red.
60 2021-04-06 skin infection at injection site, injection site bruising, injection site redness, injection site pain Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injec... Read more
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Error: Infection / Cellulitis (diagnosed by MD), Additional Details: pt says went to md cellulitis at injection site due to not given in correct spot
60 2021-04-06 pain of skin, rash On 3/31/21 woke with severe skin pain on entire left thigh. On 4/4/21 the pain continued and then th... Read more
On 3/31/21 woke with severe skin pain on entire left thigh. On 4/4/21 the pain continued and then there was a rash all around my thigh. The pain is still present and the rash has gotten worse. I went to my doctor on 4/6/21 and he says the event is caused by the vaccine. He said the symptoms resemble shingles but also varies from shingles.
60 2021-04-06 skin spots, bruising Lower right leg vein popped out about 1/2-3/4" - didn't feel anything; Lots of petechiae from back t... Read more
Lower right leg vein popped out about 1/2-3/4" - didn't feel anything; Lots of petechiae from back to feet; Blood blisters; Turned into bruise; This is 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 right on 07Mar2021 21:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included allergies: anesthesia and thrombocytopenia that developed during childbirth (went away after a few weeks). The doctors said that it may have been a drug reaction. Concomitant medication included omeprazole (PRILOSEC). The patient previously took codeine and experienced allergies -severe nausea. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. On 08Mar2021 18:00, patient's lower right leg vein popped out about 1/2-3/4" but did not feel anything. It later turned into a bruise. Lots of petechiae from back to feet and blood blisters noticed; large on torso. AE resulted in: doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment received for AE. It was also reported that the events caused hospitalization. Platelets were tested last week (unspecified date in 2021) and are on low end of normal range. Outcome of the events was unknown. Information on the lot/batch number has been requested.
60 2021-04-06 rash with redness The evening after I got my last pfizer covid 19 shot , I felt a red , hot rash, on my right buttock.... Read more
The evening after I got my last pfizer covid 19 shot , I felt a red , hot rash, on my right buttock. It was not raised. I did not seem like hives. I took Benadryl . I slept the night. It was a little less red the next day. Then, around 2pm the next evening (4/7) I had another red patch on my other buttock.
60 2021-04-06 rash Fever ranging from 99.5-101.5, fatigue, loss of appetite, rash, began 24 hours after the shot and co... Read more
Fever ranging from 99.5-101.5, fatigue, loss of appetite, rash, began 24 hours after the shot and continued for 48 hours. Used Advil, which could have been the cause of the rash but I am not certain. I often get rashes when I have a virus, and and Advil seems to make them worse. It was a little unusual in that it spread to my legs and back, as well as my face and torso. It was completely gone after 4 days.
60 2021-04-06 rash Patient reports of feeling flush. She reports she feels she has a rash on her hands. Reports of shor... Read more
Patient reports of feeling flush. She reports she feels she has a rash on her hands. Reports of shortness of breath, Blood pressure elevated and elevated Heart rate. Duration: 30+ minutes.
60 2021-04-06 hives, itchy skin, redness Hives including 1 that was blister like; Redness on arm; itching; arm soreness; This is a spontaneou... Read more
Hives including 1 that was blister like; Redness on arm; itching; arm soreness; This is a spontaneous report received from a contactable consumer. A 60-year-old (age at vaccination) female consumer reporter for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; ER8727) via an unspecified route of administration on 23Mar2021 at 11:45 am at single dose on left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Vaccine was administered at hospital facility. Patient's medical history included COPD mild (Chronic obstructive pulmonary disease) and allergies to medications, food, or other products (unspecified). Concomitant medications included (received within two weeks of vaccination) inhaler and vitamins (drug name unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Hives including 1 that was blister like, redness or arm, itching and arm soreness on 23Mar2021 at 01: 15 pm. Self- warm compression initially then iced was the treatment given. It was unknown if the patient was diagnosed with covid-19 prior to vaccination. Patient was not tested for covid-19 since the vaccination. The outcome of events was unknown. information on lot expiry has been requested.
60 2021-04-07 redness, bruising 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 2021-04-07 injection site redness, injection site pain, injection site warmth Woke up Wednesday morning and a large square red patch on right arm. When I touch it, the site is wa... Read more
Woke up Wednesday morning and a large square red patch on right arm. When I touch it, the site is warm to the touch. Also, arm is sore. Pfizer shots
60 2021-04-07 injection site pain, injection site warmth, injection site swelling, injection site pruritus, injection site redness Injection site was red, warm, large lump, very itchy and tender on Day 2. I took Tylenol. Day 3 th... Read more
Injection site was red, warm, large lump, very itchy and tender on Day 2. I took Tylenol. Day 3 the same. Day 4 today, lessening of the symptoms
60 2021-04-07 rash with redness, hives, injection site reaction Flu like symptoms for two days after. Developed red rash on top of both forearms, Hives in various p... Read more
Flu like symptoms for two days after. Developed red rash on top of both forearms, Hives in various places on body. Sores inside mouth.
60 2021-04-07 scab, shingles, rash I started with a headache the next day on my right eye. That lasted for two days and then develope... Read more
I started with a headache the next day on my right eye. That lasted for two days and then developed into a swollen eye. By the forth day I started getting a rash on my forehead and scabs which was finally diagnosed on the 5th day as shingles. The Shingles lasted about a week, but the side effects of the shingles now is terrible. It has developed in to neuralgia. Right side of face is still numb and my eyes are very sensitive to light.
60 2021-04-08 shingles I got shingles 2 weeks after first dose. Doctors say get second dose 3 weeks later (today) but bc I ... Read more
I got shingles 2 weeks after first dose. Doctors say get second dose 3 weeks later (today) but bc I have shingles I?m waiting a week or two. Listening to my two pharmacist friends and my gut/common sense. There are many people with my same story online who have gotten shingles after the first or second dose of the Covid vaccine. I don?t know how there can?t be a connection. My pharmacy?s and two doctors told me the vaccine lowers your immune system so it makes sense you would be more susceptible to getting shingles. One pharmacist said this: The common thing is to wait till it?s gone before second dose because there have been no studies done with patients with shingles and so they say wait till it?s gone just to be safe. If you have active shingles, do not get vaccinated 2nd dose until healed. Even if it is past the 42 days, it?s still fine to get the next shot. Another pharmacist said this: As of 4/8/21, the CDC does not state specifically that you cannot get the shot tomorrow due to taking valacyclovir or due to active shingles infection. In my personal opinion, If it were me I would wait until off the Valacyclovir and the shingles has gone away just to be sure your immune system is at full force. Hope that helps.
60 2021-04-08 itchy skin, injection site rash Itching, rash at and around injection site.
60 2021-04-08 rash papular, rash with redness, itchy rash Rash. Raised red. Looks like measles. Right arm. Shoulder and back. Very itchy. Taking benadryl and ... Read more
Rash. Raised red. Looks like measles. Right arm. Shoulder and back. Very itchy. Taking benadryl and applying hydrocortisone. Rash is still itchy after 2 days. Not going away yet
60 2021-04-08 hives, itchy skin, rash All over rash and hives and itching on body including face around eyes and mouth, scalp itching and ... Read more
All over rash and hives and itching on body including face around eyes and mouth, scalp itching and tongue feeling funny at times but no swelling as far as I can tell. As of 04/09/2021 I have started taken Benadryl in hopes that would help. A little headache here and there. Have taken Tylenol for that.
60 2021-04-09 injection site pain Muscle soreness at injection site and lymph nodes in left armpit within six hours of vaccination. L... Read more
Muscle soreness at injection site and lymph nodes in left armpit within six hours of vaccination. Lasted three days. Also had overall body aches, fever (up to 101.2) and chills. Lasted approximately 14 hours beginning on 3/31/2021.
60 2021-04-09 injection site pain 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 itchy skin, rash 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 itchy skin tightness in chest; Headache; dizziness; shortness of breath; nausea; itching; severe pain in both k... Read more
tightness in chest; Headache; dizziness; shortness of breath; nausea; itching; severe pain in both knees; numbness in both thighs; 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), dose 1 via an unspecified route of administration, administered in Arm Right on 21Mar2021 14:30 (Batch/Lot number was not reported) at the age of 60 years old, as single dose for covid-19 immunization. Medical history included sleep apnea, history of breast cancer left side lumpectomy, chemotherapy, radiation, asthma, osteoarthritis, vestibular disorder, allergies to unspecified medications and food, and GERD (gastrooesophageal reflux disease). The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included lisinopril (LISINOPRIL); hydrochlorothiazide; hydroxyzine; and meloxicam (MELOX); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 03:00, the patient experienced tightness in chest, headache, dizziness, shortness of breath, nausea, itching, severe pain in both knees, and numbness in both thighs. The events resulted in: doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The events were treated with Benadryl, solution medrol pf, sodium chloride. The patient has not recovered from the events. The patient has not been tested for COVID post vaccination. The events were reported as non-serious. Information on the lot/batch number has been requested.
60 2021-04-09 itchy skin Patient DOB 10/4/1960 was vaccinated on 3/17/2021 with 1st dose Pfizer, lot ER2613 expiration date 6... Read more
Patient DOB 10/4/1960 was vaccinated on 3/17/2021 with 1st dose Pfizer, lot ER2613 expiration date 6/30/2021. Patient reports medical condition includes hypertension. Allergies include sulfa and amoxicillin. Patient informed RN that after receiving the 1st dose she experienced "itchy thighs" within 3 hours that resolved 3 days later. Patient denied rash, heat, or redness. Medication includes blood pressure medication. RN notified PHN who texted PHN Supervisor, Manager, and QAS. Per medical team patient is to wait until 28 days post 1st Pfizer dose before receiving Janssen vaccine. Patient changed timing of itching to starting the next day after vaccine. Per medical team, patient is advised to consult with her provider first.
60 2021-04-10 injection site pain, itchy skin, hives First injection on 3/14/21 Migraine Headache, dizziness and mild hives lasting about 24 hours. Thes... Read more
First injection on 3/14/21 Migraine Headache, dizziness and mild hives lasting about 24 hours. These symptoms started about 30 minutes after injection. Injection site arm pain starting several hours later and lasting about 2 days. The second dose was given on 4/4/21. Hives starting about 2 hours after injection and more moderate than mild. They are larger. There are many more covering most of my body and they itch. I have had them for 7 days and am managing them with benedril. The second dose also caused mild arm pain at the injection site.
60 2021-04-10 injection site pain Mild soreness at injection sight
60 2021-04-10 injection site pain Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mediu... Read more
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: Thirty minutes after shot, patient passed out and urinated on herself. Plus, had what she discribed as a seizure.
60 2021-04-10 injection site pruritus Feeling feverish and achey, hot but not registering any high temperature. Headache. Nauseous and i... Read more
Feeling feverish and achey, hot but not registering any high temperature. Headache. Nauseous and itching at injection site. This all started at 12 hours after the shot, almost to the minute. I have been taking Ibuprofen for the aches and headache, drinking water and eating small meals, trying to rest.
60 2021-04-10 injection site rash approximately 12 hours after vaccination 4/10 woke up with severe muscle aches, arms, shins, ankles ... Read more
approximately 12 hours after vaccination 4/10 woke up with severe muscle aches, arms, shins, ankles and headache. Also felt nauseous. In morning had very slight fever and sore throat. Overnight on 4/10 woke up with extreme tightening feeling in center of chest Today 4/11 have rash on arm where I received vaccination in an area that covers an oval about 5 x 8". Took Ibuprofen in am for pain then tylenol for slight fever and pain. have marked rash to see if it spreads.
60 2021-04-10 itchy skin itching to face and facial flushing. hypertensive 151/108,78, 16,99% RA. After some time the patient... Read more
itching to face and facial flushing. hypertensive 151/108,78, 16,99% RA. After some time the patient Blood pressure improved 146/92. refused transport
60 2021-04-10 itchy skin Patient felt itching on hands, back, and face but no hives were present. Oral Benadryl administered.... Read more
Patient felt itching on hands, back, and face but no hives were present. Oral Benadryl administered. Observed for 45 minutes. Patient felt much better after Benadryl administration.
60 2021-04-10 rash with redness, rash, rash papular Raised red rash on both lower legs, some on the front of the legs ... mostly on the back of the legs
60 2021-04-11 bruising, injection site mass, injection site hardening Extreme pain from top of left shoulder to the elbow. Unable to stretch, scratch my neck, wash my ba... Read more
Extreme pain from top of left shoulder to the elbow. Unable to stretch, scratch my neck, wash my back or put on my seatbelt. The are aches so much that I can not sleep at night. I am unable to lay on my left arm. I have a large hard lump on my left arm at the injection site. Weakness in left hand. Unable to raise my arm to remove my shirt. The pain seems to be getting worse. Left inner leg bruises and pain.
60 2021-04-11 redness Feeling EXTREME dizziness and nausea that does not let up or subside. Unable to stand. feeling dizzy... Read more
Feeling EXTREME dizziness and nausea that does not let up or subside. Unable to stand. feeling dizzy. Sudden whole body heating up. Face turns red. Symptoms do not get better.
60 2021-04-11 hardening, injection site mass 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 injection site bruising, injection site pain bruising, pain in arm that still persists at site of injection, fatigue
60 2021-04-11 injection site redness, injection site swelling Arm pain immediately afterwards. Beginning at 18 hours after vaccination: excruciating headache, nau... Read more
Arm pain immediately afterwards. Beginning at 18 hours after vaccination: excruciating headache, nausea, diarrhea, elevated temperature/flushing, chills, fatigue, swelling and redness at injection site. Unable to eat or drink anything for 12 hours. Symptoms started to ameliorate after taking 1,000mg of acetaminophen around 28 hours after injection. 48 hours after vaccination, most symptoms had passed except for some residual headache and fatigue. Short fainting spell at 49 hours but did not pass out.
60 2021-04-11 injection site bleeding Bleeding at injection site. Seven minutes after being seated for observation, I fainted and vomited... Read more
Bleeding at injection site. Seven minutes after being seated for observation, I fainted and vomited while I was out for 5 minutes. An ambulance was called and took vitals for the 20 minutes after I awoke and vitals were all good, so I declined going to the hospital.
60 2021-04-11 injection site pain, injection site 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 injection site pain 102.9 degree fever off an on for about 18 hours after the first dose. Subsided by 9am the morning a... Read more
102.9 degree fever off an on for about 18 hours after the first dose. Subsided by 9am the morning after the vaccine. Also, injection arm (non-dominant arm) incredibly sore to the point of not being able to raise it, but deep tissue massaging the site alleviated this symptom by 32 hours after vaccination. Filling this out for data collection purposes. Did not take any anti inflammatory or anti-fever medications to combat. Simply sweated out the fevers and drank lots of water.
60 2021-04-11 itchy skin 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 hives, skin mass Within 30 minutes I had a headache, fatigue that lasted 2 days. I had small hives on my face startin... Read more
Within 30 minutes I had a headache, fatigue that lasted 2 days. I had small hives on my face starting day 2 lasting 2 days. I had a lump behind left ear that lasted 5 days. I have had ringing in my ears, louder in the left ear, since the injection, for 2 weeks now. It is quite loud and annoying. I have recovered from all side effects except the ear ringing.
60 2021-04-12 injection site redness, injection site warmth injection site red, hot
60 2021-04-12 injection site hardening, injection site pain, injection site warmth, injection site redness, injection site swelling Sweats Abdominal Cramps Body Aches Severe Fatigue Swelling and Redness and Induration and Warmth and... Read more
Sweats Abdominal Cramps Body Aches Severe Fatigue Swelling and Redness and Induration and Warmth and Tenderness to Palpation at site of injection after the second shot All symptoms started about 8 hours after the second dose and have continued to today. Today is the first day the symptoms seem to be decreasing in severity a little. Symptoms are worse at the end of the day.
60 2021-04-12 injection site pruritus, injection site rash Rash at injection site, severe itching at injection site, continued headaches, stomach issues, metal... Read more
Rash at injection site, severe itching at injection site, continued headaches, stomach issues, metal taste in mouth, fatigue.
60 2021-04-12 itchy skin, skin warm, skin discolouration, pain of skin, hives APPROX 2 HRS AFTER VACCINE GIVEN, STARTED TO GET HIVES, SELF MEDICATED WITH BENEDRYL, BY THE NEXT MO... Read more
APPROX 2 HRS AFTER VACCINE GIVEN, STARTED TO GET HIVES, SELF MEDICATED WITH BENEDRYL, BY THE NEXT MORNING I HAD SEVERE HIVES ALL OVER MY BODY, CONTINUED WITH BENEDRYL. ON THURSDAY MORNING WENT TO URGERT CARE AND WAS GIVEN STEROID AND ANTI ITCH PILLS. ON SATURDAY SYMPTIOMS WERE NO BETTER SO WENT TO ER CLINIC AND WAS PRESCRIBED PREDNISONE AND ADDITIONAL ANTI HISTIMINES. HIVES WERE COVERING MY ENTIRE BODY AND WERE CAUSEING MY SKIN TO BE A PURPLE, DARK RED COLOR. I AM ON DAY 7, STILL HAVE SPOTS WHERE HIVES HAVE BEEN, STILL ITCH, SKIN IS SORE AND WARM TO THE TOUCH. I HAVE 2 FULL DAYS OF MEDS TO KEEP TAKING.
60 2021-04-12 rash Rash on left arm and left torso Started valcyclavir
60 2021-04-13 injection site redness, injection site pain joint pain, chills, malaise, tiredness, injection site pain and redness
60 2021-04-13 injection site pain 04/07/21 at 1205 Pt. sitting in Vaccination monitoring area post first dose Pfizer vaccine (lot ER87... Read more
04/07/21 at 1205 Pt. sitting in Vaccination monitoring area post first dose Pfizer vaccine (lot ER8733); noted to be tearful with hand over chest. Voiced "feels like heat is beating fast all of a sudden". 1207 Pt. moved to monitoring cot into semi - reclined position. 1208 BP 140/82, HR 103, O2 sat 99%, R 20. Skin slightly clammy with no skin redness / rash or throat / tongue edema. 1208 EMS called to site. Pt denies medical hx or any allergies. 1213 Pt. voiced "HR starting to feel better, only notes some lightheadedness / spacey feeling; P 91 / Sat 98%. 1215 BP 132/78, P 65, R 18, Sat 98% - Voiced "thinks everything is okay now; notes only dull ache at right arm injection site. Pt. also called husband to site at time. 1217 EMS arrives and pt. assessed. 1226 EMS provided pt. education on self monitoring & hospital f/u. Pt. declines transport to hospital; will monitor self at home with assist of husband: sitting on side of cot. 1228 EMS departed scene and pt. husband now present; P - 61 and O2 98%. 1229 Pt. and husband voiced readiness to leave. Educated to let pt. PCP know about events post vaccination. Pt. voiced understanding and will just monitor self at home. Both ambulated to from site together
60 2021-04-13 injection site pain Moderate soreness at injection site that started 10 1/2 hours or so after I received the 1st shot. T... Read more
Moderate soreness at injection site that started 10 1/2 hours or so after I received the 1st shot. The soreness lasted about a day and a half.
60 2021-04-13 injection site swelling, injection site redness Patient reported redness and swelling at injection site.
60 2021-04-13 skin burning sensation Immediate trigeminal nerves triggered, mouth tingled, slightly dizzy, blurred vision. 1/2 hr later ... Read more
Immediate trigeminal nerves triggered, mouth tingled, slightly dizzy, blurred vision. 1/2 hr later felt like skin burning on face and arms looking like a sunburn, small fiber neuropathy kicked up throughout body. Next morning slight headache and slight dizziness, slight sweating. Subnormal temp all day. Burning feeling, sunburned skin continues as it comes and occasionally lessens.
60 2021-04-13 hives, itchy skin, rash All over rash and hives and itching on body including face around eyes and mouth, scalp itching and ... Read more
All over rash and hives and itching on body including face around eyes and mouth, scalp itching and tongue feeling funny at times but no swelling as far as I can tell. As of 04/09/2021 I have started taken Benadryl in hopes that would help. A little headache here and there. Have taken Tylenol for that.
60 2021-04-14 injection site bruising, injection site pain pt says that her arm was very sore after taking the vax but then she developed a fist size bruise at... Read more
pt says that her arm was very sore after taking the vax but then she developed a fist size bruise at the injection site. there is no fever or soreness any longer but the bruise has been there for almost 2 weeks. She went to PCP Dr. on 4/12/2021 and she was told it was not a bruise and to contact the vax manufacturer since he wasn't sure what it was.
60 2021-04-14 injection site pain, injection site redness Injection site red and sore Chills Temperature 99.8
60 2021-04-14 nerve compression In addition to common symptoms listed on the CDC website ( soreness in arm, muscle and body aches, f... Read more
In addition to common symptoms listed on the CDC website ( soreness in arm, muscle and body aches, fatigue) I experienced tingling and numbness in hands and feet, and tingling in the face. It got progressively worse over the next few days, and started getting better each day after Sunday 4/11/20. I went to my doctor?s office yesterday, and since he was not available, I saw the nurse practitioner. She checked me out and did a needle test as well. She said that although this is not listed on the common side effects, that it appears to be a side effect. She said since I am getting better each day, it will likely resolve itself in a week or two. She feels that my nerves are inflamed. I was not prescribed anything, and since I do take a dose of gabapentin each day, this should help.
60 2021-04-14 itchy rash, skin warm, rash, rash with redness Client reported receiving COVID vaccine second dose on 04/12/21 at 1:30 pm, adverse reaction began l... Read more
Client reported receiving COVID vaccine second dose on 04/12/21 at 1:30 pm, adverse reaction began later that day at 3:30 pm. Client report a rash started on both arms, then felt rash went to her ears, they felt like they were getting bigger as well. Rash moved to other parts of her body such as face, trunk, and legs. Rash is itchy, reddish in color, warm to touch, and very painful all over. Client also report getting the same rash after first COVID vaccine on 03/22, but that rash only lasted 2 days. Client seen by PCP for this recent reaction, prescribed hydroxyzine and a hydrocortisone cream. Client report no improvement and plan to contact PCP again regarding rash.
60 2021-04-15 bruising Pt was given second dose of vaccine on 0412/2021. She developed severe pain of forearm and wrist. Sh... Read more
Pt was given second dose of vaccine on 0412/2021. She developed severe pain of forearm and wrist. She had applied ice to site and today noticed a bruise on her inner wrist (4 x 2 inch). Denies taking any blood thinner and denied trauma. No warmth or pain at this time. She took 800 mg Ibuprofen night before vaccine for back injury. She applied ice to site. PCC: Advised to FU with pcp, urgent care or ED for cbc and coags. Although Pfizer vaccine has not been known to cause clotting issues and sx could be unrelated it is best to r/o. Caller will be going to home on Friday and said she might wait to fu with pcp there.
60 2021-04-15 shingles, rash Extreme arm pain began 4/7, Shingle rash outbreak on 4/9, diagnosed with Shinges on 4/11. Prescribe... Read more
Extreme arm pain began 4/7, Shingle rash outbreak on 4/9, diagnosed with Shinges on 4/11. Prescribed Valtrex for 7 days
60 2021-04-15 itchy skin, rash, hives her eye looks like a bee stung her eyelid, it is swollen; hives on face; rash on her legs and her le... Read more
her eye looks like a bee stung her eyelid, it is swollen; hives on face; rash on her legs and her legs were itching; rash on her legs and her legs were itching; This is a spontaneous report from contactable consumer (patient). A 60-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/lot number: EK9231; Expiration Date 30Apr2021) via unspecified route of administration in right on 11Jan2021 at 16:00 as single dose for COVID-19 immunisation. The patient medical history not reported. historical vaccine included BNT162B2 (First dose: 21Dec2021; Lot number: EL0140; Expiration Date: Mar2021) and concomitant medications were not reported. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021, the patient reported hives on face that were red and bumpy. They are not as bumpy but it is still red like her face looks sunburned red and her eye is swollen, rash on her legs and her legs were itching, on 03Feb2021 her eye looks like a bee stung her eyelid it is swollen. Treatment received for the events with Prednisone. The outcome of the events (Urticaria, rash, pruritus) was unknown, her eye looks like a bee stung her eyelid, it is swollen was not recovered. Description of Product complaint: Caller was calling about the Pfizer COVID vaccine. She says she wanted to report having a reaction. She had hives, like a rash and her eye looks like a bee stung her eyelid, it was swollen. She had a rash on her face and her legs and her legs were itching, it was like hives on her face that were red and bumpy. They are not as bumpy but it was still red. She has been taking Prednisone and she was not sure if that is why its getting a little bit better but it was still really red and itching and the swollen eye was a new thing. Her Prednisone was in an amber color pharmacy bottle and does not see an NDC lot or expiration on there.
60 2021-04-15 rash Rash on injected arm. ( not at injection site)
60 2021-04-15 hives Hives on both hands immediately following injection. Given Benadryl 12.5mg PO by EMS.
60 2021-04-16 bruising, vaccination site pain Bruising; Soreness and pain in left arm at site; Soreness and pain in left arm at site, under arm pi... Read more
Bruising; Soreness and pain in left arm at site; Soreness and pain in left arm at site, under arm pit; Soreness and pain in left arm at site, under arm pit and around breast; This is a spontaneous report from a contactable other 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 26Jan2021 (Batch/Lot Number: EL9261) as single dose for covid-19 immunisation (age at vaccination was 60 years). No other vaccine in four weeks and other medications in two weeks were reported. No Known allergies and no other medical history were reporter. Historical vaccine included dose 1 via an unspecified route of administration, administered in Arm Left on 05Jan2021 at 07:45 AM, (Batch/Lot Number: EK4176) as single dose for covid-19 immunisation (age at vaccination was 60 years). Following mammogram 26 days after (as reported) second dose the patient experienced bruising and soreness and pain in left arm at site, under arm pit and around breast on 19Feb2021 at 16:00. The patient recovered with lasting effects. No treatment was received for the events. No covid reported prior vaccination. Covid wasn't tested post vaccination. The patient underwent lab tests and procedures which included mammogram: unknown result. Outcome of events was recovered with sequelae on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.
60 2021-04-16 redness 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 2021-04-16 injection site redness, injection site swelling, injection site pain, injection site warmth Injection on 04/08/2021; On 4/16/2021 injection site in Right Arm became swollen and red like a ?tar... Read more
Injection on 04/08/2021; On 4/16/2021 injection site in Right Arm became swollen and red like a ?target?, warm to the touch and sore. Reporting on 04/17/2021 so do not know the outcome of said event
60 2021-04-16 itchy skin itchy lips, then itchy scalp and feet. started 45min after shot. lips may have been swollen or may h... Read more
itchy lips, then itchy scalp and feet. started 45min after shot. lips may have been swollen or may have seemed that way because of itchiness. I could not see them. lips issues ended within an hour from starting and the rest of itchiness ended after 2-3 hours. headache next day and lifting arm soreness next day.
60 2021-04-16 hives Hives all over entire body
60 2021-04-17 injection site pain Fever 101.0; chills; fatigue, throwing up, soreness at injection site
60 2021-04-17 injection site pain Shot 1: Site soreness (severe) lasting 1 week, fever, chills, headache, tiredness 48 hours. Shot 2: ... Read more
Shot 1: Site soreness (severe) lasting 1 week, fever, chills, headache, tiredness 48 hours. Shot 2: Site soreness (not as bad as shot 1) for 1 week. 48 hours tiredness, headache, chills, fever. Next 48 hours: tired, headache. One week later starting experiencing dizziness, fatigue, tinnitus. Continuing off and on one month after 2nd vaccine. Have a good then several bad days. Seems to be getting worse and more chronic. Wake up tired but not dizzy and within 45 minutes dizziness starts up and continues through until late afternoon. Fatigue is chronic and fairly bad no matter how much sleep I get. Tinnitus (which I have never had before) is consistent but not super severe. Never had dizzy spells or vertigo before either.
60 2021-04-17 vaccination site pain Site injection soreness; Site injection soreness, fatigue; This is a spontaneous report from a conta... Read more
Site injection soreness; Site injection soreness, fatigue; This is a spontaneous report from a contactable consumer (Patient) or other non hcp. A 60-years-old female patient received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN8730) dose 1 via an unspecified route of administration, administered in arm Left on 29Mar2021 02:00 as single dose for covid-19 immunisation. Medical history included blood cholesterol increased. Concomitant medications included simvastatin (SIMVASTATIN), ergocalciferol (CALCIFEROL VIT D), omega-3 (OMEGA-3 NOS) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. She experienced site injection soreness and fatigue. The patient did not receive treatment for the events. The outcome of the events were recovered. No follow-up attempts are needed. No further information is expected.
60 2021-04-18 blister, shingles, rash with redness 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 injection site redness, rash with redness, injection site warmth, injection site rash Three hours after receiving the 2nd dose, right arm begin to ache. Felt ache down the arm into the h... Read more
Three hours after receiving the 2nd dose, right arm begin to ache. Felt ache down the arm into the hand and fingers. Body aches and chills through out the night ache across the shoulders, neck and up toward the base of the neck and lower back. Next day symptoms were slightly worse I developed a slight headache became very listless had to go to bed. Friday night, the injection site arm developed a red rash that was warm to the touch.
60 2021-04-18 injection site swelling After vaccine administration in the right deltoid muscle, patient's arm swelled at the injection sit... Read more
After vaccine administration in the right deltoid muscle, patient's arm swelled at the injection site. Patient was given one dose of 25mg Benadryl as a precaution.
60 2021-04-19 shingles Small lesion appeared under right shoulder blade on back, thought it was a bite and put triple antib... Read more
Small lesion appeared under right shoulder blade on back, thought it was a bite and put triple antibiotic cream on it, radiating pain through right breast - took 200mg Advil every 6 hours for 3-4 days. Made dr appt after a photo taken looked to me like shingles. Dr diagnosed herpes/varcella zoster. No further treatment.
60 2021-04-19 injection site pain I experienced the known, Headache, body/joint pain, injection site pain....what followed was severe ... Read more
I experienced the known, Headache, body/joint pain, injection site pain....what followed was severe abdominal pain followed by frequent diarrhea & high levels of gas. This started approx 10 hours after my second injection(on Wed 4/14/21)and lasted until midday 4 days (Sunday 4/18/21). I did not run a temperature. After waiting for it to go away (48 hours), I called COVID-19 line and they said to go to BRAT diet. I did that & added Pedialyte to replenish electrolytes & help with the extreme fatigue(over and above my usual MS fatigue). I also treated the extreme gas with gas-x chewable tablets. The diarrhea was like prepping for a colonoscopy, nothing stayed in my system & the stools were very loose & yellow in color.
60 2021-04-19 injection site swelling, injection site redness Dose 1: Redness, swelling at injection site, Headache, dizzy, nauseous, fever over 100 degrees F. Ev... Read more
Dose 1: Redness, swelling at injection site, Headache, dizzy, nauseous, fever over 100 degrees F. Everyday or every other day. Diarrhea, muscle aches, joint aches, neck pain, fatigue all lasting 2-3 weeks. Still had 100 degree fever the night before Dose 2. Told nurses at Super Station about all the side effects from first dose and they had me take a Benadryl before 2nd shot, stay 30 min. for observation, then they told me to take Tylenol when I got home, which I did. Taking 2-3 more over the next day or so. Did not get redness or swelling at shot site, did have headache, fever, fatigue, muscle and joint pain, but much more muted than with the first dose with no medication. I continue to have a fever of 100 degrees about every 2-3 days. Some days I have diarrhea or feel headachy and have to be in bed most of the day. Usually fever is first symptom on those days. It's been 3 weeks since last dose and my fever was 100 yesterday and spent 15 hours in bed.
60 2021-04-19 itchy skin, redness Redness to face/arms, Itching to body Shortness of breath, Feeling it move to my mouth, throat, nose... Read more
Redness to face/arms, Itching to body Shortness of breath, Feeling it move to my mouth, throat, nose, so far some symptoms have lasted 3 days
60 2021-04-19 rash with redness, itchy skin Sore arm 2 days after vaccine with red rash. Soreness and itching on arm on day 3
60 2021-04-19 rash On Sunday I felt a little achy and after working from 12 -4 pm came home and went to bed because I ... Read more
On Sunday I felt a little achy and after working from 12 -4 pm came home and went to bed because I had the chills. I know I had taken my temperature around 10 am and it was 100.1 degrees. After I went to bed I know my fever escalated, but I didn't check it again, thinking it was just the reaction to the shot. I did take some Ibuprofen, too. Monday I felt fine. On Tuesday 4/20/21, I noticed after my shower a rash on my neck and chest area. I have been taking a Women's One A Day vitamin for about a week, but that is the only thing other than the Ibuprofen I have taken. I will call my Dr to report as well.
60 2021-04-20 redness, rash Adverse effect of vaccine, initial encounter Rash - Notes that rash started after she received the... Read more
Adverse effect of vaccine, initial encounter Rash - Notes that rash started after she received the second COVID dose but unable to state exactly when the rash started - Vaccine received in left arm and has a rash to left upper arm and chest - + redness - Denies fever, chills, itchingPlan: - Likely related to recent COVID vaccine - Will have clinic RN submit VAERS report - Recommend a moisturizer - Pt will continue to monitor for worsening symptoms - Follow-up with PCP as needed for concerns
60 2021-04-20 injection site numbness Right facial/injection site numbness Vital Signs: BP 150/100 HR 76 (84) Resp 20 O2Sat 98 Skin Sign... Read more
Right facial/injection site numbness Vital Signs: BP 150/100 HR 76 (84) Resp 20 O2Sat 98 Skin Signs: Clammy, diaphoretic Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Initial Treatment: Observation, patient remained AOx4. Assessed/evaluation by Doctor. 12:10 PM Vital Signs: BP 138/90 HR 74 Resp 20 O2Sat 93 Skin Signs: Clammy (mild), Diaphoretic Circulation: Cap refill <2sec Follow up Treatment: Patient states numbness in face has lessened in severity Notes: Encouraged patient to continue hydration at home Disposition: Home with friend
60 2021-04-21 shingles Reactivation of shingles.
60 2021-04-21 injection site bruising I really don't know if this is at all related to the second vaccination but we were encouraged to re... Read more
I really don't know if this is at all related to the second vaccination but we were encouraged to report any odd experience. About 27 hours after receiving the second shot, what appears to be a menstrual cycle began. I last had my period in 2015. For additional context, I have a history of fibroids and still have a good sized one. In late February I had a spotting issue but what I'm experiencing now is a full on period. I was already in contact with my PCP and an OB/GYN for testing related to the Feb. spotting event and as a result of that will be having an endometrial biopsy and hysteroscopy. Outside of the above, I had a sore arm and bruising at the injection site. Thank you
60 2021-04-21 injection site hives, injection site swelling, injection site pain, injection site redness Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec... Read more
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient reported significant swelling and a 4 inch raised hive at injection site. Patient took Benadryl and it went down and resolved after a few days. Reaction started on day 8 after injection.
60 2021-04-21 itchy skin, hives Patient reported that she had itching and hives 24 hours after receiving 1st dose of Covid vaccine. ... Read more
Patient reported that she had itching and hives 24 hours after receiving 1st dose of Covid vaccine. Pt. reports taking benadryl and hives going away after unspecified time.
60 2021-04-21 rash, rash with redness 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 rash, skin discolouration 1) Extensive spots, reticular discoloration of the legs, some spots redder than others. In calves of... Read more
1) Extensive spots, reticular discoloration of the legs, some spots redder than others. In calves of both legs. 2) Sharp breast pain, on the left breast,
60 2021-04-21 rash, skin irritation, shingles Developed fatigue and nausea two days after vaccine. Began to have skin irritation the same day. Dev... Read more
Developed fatigue and nausea two days after vaccine. Began to have skin irritation the same day. Developed a rash five days after vaccine and was diagnosed with shingles six days after vaccination. Took Enbrel and methotrexate two days after vaccination.
60 2021-04-21 skin warm, cellulitis 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 2021-04-21 hives Hives - head, neck, arms, chest and trunk.
60 2021-04-22 skin irritation Severe skin reaction:vacuolar interface dermatitis
60 2021-04-22 redness, itchy skin, hives Individual arrived to post vaccine area moments after COVID 19 Pfizer vaccine dose 1. Individual not... Read more
Individual arrived to post vaccine area moments after COVID 19 Pfizer vaccine dose 1. Individual noted some redness itching and hives to the forehead, neck, and arms bilaterally. Individual denied difficulty breathing, denied tongue lip or throat swelling. Individual had no issues handling saliva, no stridor/objective shortness of breath. Vital signs: 153/90 HR 71, O2 100% taken by post vaccine nurse. Individual given 25mg PO Benadryl at 11:20, monitored by post vaccine nurse until 12:40. At 12:35 symptoms resolved. Escorted by sister, instructed/agreed not to drive.
60 2021-04-22 shingles, rash Shingles rash onset 4/16.
60 2021-04-22 injection site pain Injection site pain, extreme tiredness, ?hangover? headache/awful headache, joint pain, 101 degree f... Read more
Injection site pain, extreme tiredness, ?hangover? headache/awful headache, joint pain, 101 degree fever, feeling unwell, no appetite (but not nauseous) X 1-1/2 days Sore arm/difficulty raising arm X several days; tolerable
60 2021-04-22 injection site pain Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mediu... Read more
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Nausea-Medium, Systemic: Vomiting-Severe, Error: Incorrect Reconstitution
60 2021-04-22 itchy skin, skin warm At time of injection- immediate warm sensation in stomach, neck and face. Slight flush color in face... Read more
At time of injection- immediate warm sensation in stomach, neck and face. Slight flush color in face. Itching in face and forehead however NO signs of hives or labored breathing. Intake if fluids. No Benadryl or Epi-pen required. Symptoms diminished and left facility in 10-15 minutes. 2-3 hours later- body aches, mild nausea and mild headache. NO Tylenol 1 am- woke from sleep- Headache . Took 2 Tylenol. Went to sleep. Woke at 6 am- string body aches, nausea, and very sore arm. NO headache. Took Tylenol. Stated in bed with fluids until 2 pm. Little appetite. Slight headache in evening. Achey feeling subsided . Next day - Mild body aches and nausea. Took one Tylenol. No appetite.
60 2021-04-22 rash post vaccine pt was noted to have a light rash on upper extremities, c/o of tightness in chest. Pt o... Read more
post vaccine pt was noted to have a light rash on upper extremities, c/o of tightness in chest. Pt offered Benadryl and refused as pt had a full schedule planned today. Pt expressed that she was feeling well enough to leave on her own. Pt was released at 10:47 am vital as follows: 1032 BP 136/89 HR 94 RR 20 SpO2 97% 1040 BP 137/91 HR 92 RR 20 SpO2 98% 1045 BP 138/90 HR 83 RR 18 SpO2 99%
60 2021-04-22 hives Hives to all extremities except LUE
60 2021-04-23 shingles, rash Shingles/rash/bites or something around mid section where shingles would normally appear. Link I fou... Read more
Shingles/rash/bites or something around mid section where shingles would normally appear. Link I found on line was for rare reaction in women.
60 2021-04-23 shingles Mild case of Shingles on right hand
60 2021-04-23 injection site redness, injection site hardening, injection site swelling, injection site warmth Injection site is warm to the touch, red in color, swollen and very firm to the touch.
60 2021-04-23 injection site rash, injection site pruritus, rash with redness, sensitive skin 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 2021-04-23 itchy skin, rash vesicular, rash, shingles, pain of skin On 3/15/2021 my neck and scalp began to itch/hurt. . On 3/18/2021 my scalp broke out in rash consist... Read more
On 3/15/2021 my neck and scalp began to itch/hurt. . On 3/18/2021 my scalp broke out in rash consisting of blisters that wept and formed crusts. On 3/19/2021 I was diagnosed with shingles and started on an anti-viral medication and gabapentin.
60 2021-04-23 itchy skin Systemic: Allergic: Itch Generalized-Medium, Additional Details: Administered second dose on right a... Read more
Systemic: Allergic: Itch Generalized-Medium, Additional Details: Administered second dose on right arm. Client reported no reaction after first dose except for sore arm. No history of allergies or adverse reactions from vaccine. Reported generalized itchiness. Gave 50 mg Benadryl. Client's husband drove her here and back home. First dose of vitals: 97.7 degrees F, 82 bpm, 98% O2, 130/94 BP, RR 16 at 1756. Second dose of vitals taken 1815: 72 bpm, 98% O2, 97 degrees F, BP 120/80. Client left approx. 1830 reports decreased generalized itchiness.
60 2021-04-23 rash Severe dizziness, rare front or left headache with pain, pain in both eyes and left eyelid tremor, d... Read more
Severe dizziness, rare front or left headache with pain, pain in both eyes and left eyelid tremor, diarrhea, muscle and joint pain, stiff fingers, feet and leg muscles, rash all over the body, fatigued and shortness of breath, tiredness.
60 2021-04-23 hives, itchy skin, redness Local Reaction o hives, itchy, red R arm/L arm Systemic Reaction o neck, scalp, stomach, arms: hi... Read more
Local Reaction o hives, itchy, red R arm/L arm Systemic Reaction o neck, scalp, stomach, arms: hives, itchy; runny nose, scratchy throat Pt reported reaction started just under 2 hrs post covid vaccine, and had not resolved at time of call 3.5 hours later
60 2021-04-24 bruising 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 redness Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc... Read more
Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) lump in my throat; turned red on my face and neck and chest and arms; when I get nervous; between my eyes on my forehead felt like a round circle (no bump) (past the bridge above eyebrows). It didn't hurt, but I felt something; felt odd; felt like my eyes were moving back and forth; very very cold; hands were ice cold; This is a spontaneous report received a contactable consumer, the patient. A 60-year-old adult female received the first dose BNT162b2 (solution for injection; batch/lot and expiry information not reported) as a single dose via unspecified route on 14Mar2021 (at 60-years-old), for COVID-19 immunisation. Relevant medical history included high blood pressure, and diabetes. There were no concomitant medications or past drug history reported. The patient reported that she had a couple of reactions the first day, so she was afraid to take the second one. The patient stated that within eight minutes she had a lump in her throat, which she gets when she is nervous and was unsure if from shot or nervousness. The patient reported that then she turned red on her face, neck, chest, and arms. The patient reported that the redness lasted about six or seven hours and did not bother her at all. The patient explained that then between her eyes on her forehead felt like a round circle (no bump) past the bridge above eyebrows. The patient stated that it did not hurt but felt like something. The patient also stated that she felt like she was going to get headache, though did not. The patient reported that it just felt odd. The patient also stated that she felt like her eyes were moving back and forth. Though when she looked in the mirror, they were fine. The patient stated that the eyes happened three times but by the time she looked in the mirror they looked fine. The patient added that she never felt sick or anything though about six or eight hours later she got very very cold which only lasted about a minute. The patient stated that her hands were ice cold and then it all went back to normal. The outcome of the events turned red on my face and neck and chest and arms was recovered on an unspecified date in Mar2021 after 6-7 hours. The outcome of the event she got very very cold was recovered on an unspecified date in Mar2021 after one minute. The outcome of the events hands were ice cold, and felt like my eyes were moving back and forth was recovered on an unspecified date in Mar2021. The outcome of the events, lump in my throat, get nervous, between my eyes on my forehead felt like a round circle (no bump), felt something, and felt odd, was unknown. Information on lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
60 2021-04-24 injection site pain Fever, chills, muscle aches, malaise, site pain extending down arm and into shoulder, headache, naus... Read more
Fever, chills, muscle aches, malaise, site pain extending down arm and into shoulder, headache, nausea. Adverse events lasted 2 days. Treated with tylenol.
60 2021-04-24 injection site swelling, injection site redness, injection site pruritus, injection site rash, rash, itchy skin Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic:... Read more
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient complained of redness, some swelling, and itchyness,and a rash at the site of injection and that was on the chest as well that lasted about 14 days and she treated it with hydrocortisone cream
60 2021-04-24 rash, itchy skin Four days after I felt a sore area on my shoulder. Next morning I had a rash on my shoulder and dow... Read more
Four days after I felt a sore area on my shoulder. Next morning I had a rash on my shoulder and down my arm. The worst areas were my shoulder and inside elbow. It was like a burn. Felt and looked like a motorcycle muffler burn I once had. I waited it out and it began to hurt less and itch. After 6 days it is only a pink area where it was broke out.
60 2021-04-25 injection site pruritus 04/26/21 @ 1324 Patient c/o itching at injection site right arm. Upon assessment, there was no redne... Read more
04/26/21 @ 1324 Patient c/o itching at injection site right arm. Upon assessment, there was no redness, swelling, Skin Temp WNL, no skin discoloration at the injection site. VS 97% O2, 87HR, BP: 190/98. 1330 - Benadryl was administered 50 mg tab by mouth. 1345- Patient states, "I feel better, I no longer have itching on my arm".
60 2021-04-25 rash, skin discolouration, itchy skin pt was waiting in the waiting area , after 5 minutes patient started itching and had pink skin due t... Read more
pt was waiting in the waiting area , after 5 minutes patient started itching and had pink skin due to rash
60 2021-04-26 psoriasis Body aches, skin feels like its burning but no fever, psoriasis flared up on my legs and it had been... Read more
Body aches, skin feels like its burning but no fever, psoriasis flared up on my legs and it had been cleared up, frequent chest pains.
60 2021-04-26 rash Patient had flushing/sweating, rash. Given Benadryl 25 mg PO. Patient stable, released from vaccinat... Read more
Patient had flushing/sweating, rash. Given Benadryl 25 mg PO. Patient stable, released from vaccination site.
60 2021-04-26 skin discolouration I have a dark circle on my arm where the vaccine was given..the circle is dark.
60 2021-04-26 hives Hives - on thighs, belly, lower back, rear of arms. I've had hives previously and these progressed ... Read more
Hives - on thighs, belly, lower back, rear of arms. I've had hives previously and these progressed as I've experienced before. Treated with OTC antihistamines and aleve for 1 week, then video visit with PCP. Prescribed Montekulast 1 per day, and hives improved within 24 hours and continually improved until gone as of today April 27 - approx 2 weeks after symptoms started.
60 2021-04-26 vaccination site haemorrhage This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt1... Read more
This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 12:30 (at the age of 60-years-old) (Batch/Lot Number: ER-8730) as SINGLE DOSE for covid-19 immunization. Medical history included Hypothyroid, High Blood Pressure. Concomitant medications included levothyroxine sodium (SYNTHROID); losartan potassium (LOSARTIN); amlodipine; hydrochlorothiazide; all taken for unspecified indications, start and stop dates were not reported. On 27Mar2021 13:30, the patient experienced Bleeding at the site, fainting and vomiting while passed out for 5 minutes. The patient believes the injection was too high and she hit a vein. It was further reported that the patient is not a squeamish person and have never had reactions to any shots or blood draws in the past. The event fainting and passed out was assessed as serious (medically significant). Therapeutic measures were taken as a result of bleeding at the site. The patient did not receive treatment for the events fainting, passed out, and vomiting. The outcome of the events was recovered.
60 2021-04-26 vaccination site pain, injection site redness, itchy skin, rash with redness, rash macular, rash papular Patient complained of vaccine site feeling burning & on fire. area red, scattered red raised macula ... Read more
Patient complained of vaccine site feeling burning & on fire. area red, scattered red raised macula rash with itching on upper arm and axilla at 4:40pm. Cetirizine 10mg oral given, ice pack applied at 4:45pm. Redness and burning improved at 5:10. No signs of respiratory distress or signs of anaphylaxis. Reported to physician. Patient to take Cetirizine for next few days. Ambulated to car without any incident, daughter driving.
60 2021-04-26 vaccination site pain 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 2021-04-27 shingles jaw pain, stabbing in ear, face broke out, went to urgent care, shingles
60 2021-04-27 itchy skin, shingles, rash Had prior pain from shoulder blade up to neck and ear. Lasted 3-4 days. Had been increasingly Itchy... Read more
Had prior pain from shoulder blade up to neck and ear. Lasted 3-4 days. Had been increasingly Itchy. On 4/23/2021, rash on shoulder neck. Went to dr rash not there. Treated for shingles. Rash reappeared later that evening. Husband received vaccine same date/time. Being Treated for shingles. He reported his event
60 2021-04-27 rash papular, itchy skin I got one papulovesicle on my left side of back with a little itching at first day and became seven ... Read more
I got one papulovesicle on my left side of back with a little itching at first day and became seven papulovesicles today with the paint the left side of breast. I had suffered Herpes zoster 20 years ago. I thought this symptoms might be reactivation of Zoster.
60 2021-04-27 rash 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 redness 1) Slight redness in neck/chest area approx. 75 mins after shot 2) Tingling, pins&needles on both si... Read more
1) Slight redness in neck/chest area approx. 75 mins after shot 2) Tingling, pins&needles on both sides of face between jaw and cheekbones approx 90 minutes after shot that lasted for about 10-15 minutes. This was followed by numbness around cheekbone area that gradually went away by 4/29/2021 Emergency room doctor gave me antihistamine and I took antihistamine 6 hours later before bedtime and twice the following day. I also used a coldpack on my face. 3) Two days after shot 4/29/2021, slight numbness at tip of my little finger on right hand started in the morning.
60 2021-04-28 redness 1/11/2021: Within 40 minutes of receiving 2nd dose Pfizer vaccine, began having tingling bilateral a... Read more
1/11/2021: Within 40 minutes of receiving 2nd dose Pfizer vaccine, began having tingling bilateral arms proximal & distal. Following day, developed a temperature to 102F which remained x4 days. Since this time, has had continued tingling of the arms & low grade temperature (99F) & has begun having weakness of her upper extremities only with hypersensitivity to heat, as well as touch, but interestingly having decreased sensation to touch of her fingers, feeling as though she wears gloves, with no weakness anywhere else on her body. She has also beginning to develop a sense of decrease cognition. She has been seen by Neurology who felt this was a neurologic hypersensitivity reaction. Initially when she began having complaints following injections/day 1, she was given Benadryl with no improvement beyond causing her to sleep. Since this time she has also been placed on prednisone with no interval improvement. Relates no cutaneous lesions beyond mottling of her arms/no frank urticaria dermatitis etc., and has had no GI complaints or cardiovascular sequela. 4/19/21: This 60 y.o., female is referred by MD for evaluation of bilateral hand pain, weakness and numbness starting shortly after the 2nd dose of her COVID vaccine (5 her). The patient has generally been in excellent health. On Monday, January 11th at 9:20 a.m. she received the 2nd dose of COVID vaccine (Pfizer), in the left deltoid. She had no immediate reaction but while driving about 45 min later developed numbness and tingling bilaterally in her face, lips, tongue and hands. She awakened at about 3:00 a.m. with fever of 102, no abnormal sensations in her face but pain, redness and sensitivity in both hands. Systemic symptoms resolved in several days. Hand symptoms have continued to date. Pain can range as high as 8/10. She has marked sensitivity such that if she or someone else touches her hands it is extremely painful. She sleeps with opera gloves to protect them. She has not had neck pain but has developed grip weakness and has to use 2 hands to hold a cup of coffee. She has never had adverse reactions to vaccines in the past. She has had no immunologic disorders. She initially saw Dr. who tried a short course of steroids without benefit. She took gabapentin 200 mg followed by 100 and slept for hours without a change in the pain. NSAIDs have been ineffective. No other medications have been tried. She has had nothing to suggest a symptomatic COVID infection. 4/23/21: The patient continues to have bilateral hand sensitivity and temperature lability. The EMG showed diffusely slow sensory conductions, consistent with the non correctable low temperature of her hands. Motor conductions were notable for slowing in the right median motor with drop in amplitude proximally but with waveforms that did not suggest conduction block. All motor terminal latencies and F response latencies were normal. Overall the study is probably normal within technical limitations but if necessary should be repeated in about a month with her hands warmer. The nortriptyline was just approved yesterday and the blood tests 2 days ago. She will start the nortriptyline over the weekend and let me know if it is tolerable or effective. She will get the blood work done early next week and I will review the results with her. HISTORY: This patient with bilateral hand dysesthesias and temperature lability following COVID vaccination comes in for neurophysiologic testing. Notably the nortriptyline was just approved and she has not yet started taking it. Similar the blood test were just approved 2 days ago and she will have them drawn next week. Her symptoms have not changed since he was here last.
60 2021-04-28 itchy skin, hives Pt mentioned to the vaccinator that she had developed hives after her first shot that she received o... Read more
Pt mentioned to the vaccinator that she had developed hives after her first shot that she received on 3/2/2021. She complained of itchiness and hives and had to take benadryl for 2 days until they were gone. PT stayed at recovery area for 30 minutes to monitor for any anaphylactic response. She left without further issues. Contact information given to Pt in case anything develops later today.
60 2021-04-28 itchy skin Extreme itching hands, arms and face
60 2021-04-28 itchy rash, rash Symptoms: Skin rash (exanthema) initially appeared on left arm on 4/27 (4th day after vaccination) a... Read more
Symptoms: Skin rash (exanthema) initially appeared on left arm on 4/27 (4th day after vaccination) and extended to upper back over the following 1 -2 days. Eventually the skin rash appeared over both left and right arms as well as full back. No pain but itchy. Syptom still persists as of today (4/29) Hemorrhoid broke and blood came out (4/29). Time course: 4 - 5 days
60 2021-04-29 eczema A very bad Flare up of Eczema on right hand. Very unusual since I have my eczema under control.
60 2021-04-29 rash, rash maculo-papular, itchy rash Onset of pruritic maculopapular rash on trunk that spread to neck 55 hours after vaccination. Respo... Read more
Onset of pruritic maculopapular rash on trunk that spread to neck 55 hours after vaccination. Responded to treatment with H1 and H2 blockers. No steroids required. No anaphylaxis noted.
60 2021-04-29 rash 60 yo female received her first pfizer vaccine on 3/20/21; she tested positive for Covid on 4/1/21 a... Read more
60 yo female received her first pfizer vaccine on 3/20/21; she tested positive for Covid on 4/1/21 and took tylenol and motrin for her symptoms. She broke out with a rash on her right lower back on 4/6/21 that spread to her left lower back after one day and then moved to her chest. She was concerned that she had a shingles outbreak. (of note, she had a shingles vaccine in Fall 2020). She reports she did not have a medical evaluation to determine the diagnosis of this rash. She did not put anything on the rash. The rash lasted approximately 5 days and resolved spontaneously. She has not symptoms now and was calling to ask if she could get her second vaccine.
60 2021-04-30 shingles, rash Patient has shingles with severe pain and rash
60 2021-04-30 injection site 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 injection site pruritus, injection site warmth, injection site swelling, injection site rash ?Vaccine arm ?as described in the clinic, Delayed Large Local Reactions to mRNA-1273 Vaccine against... Read more
?Vaccine arm ?as described in the clinic, Delayed Large Local Reactions to mRNA-1273 Vaccine against SARS-CoV-2 April 1, 2021 N Engl J Med 2021; 384:1273-1277 DOI: 10.1056/NEJMc2102131 Red rash at vaccine site, itching, swelling, hot to the touch .
60 2021-04-30 injection site reaction Client received her first Pfizer-BioNTech COVID-19 Vaccine at about 12 noon on 04/09/2021 with lot n... Read more
Client received her first Pfizer-BioNTech COVID-19 Vaccine at about 12 noon on 04/09/2021 with lot number ER8731 exp. 07/2021. Client's daughter reported to EMT that her mother's arm was twitching at the site of the injection. Patient has a history of Carpal tunnel syndrome for the last 10 years, stroke in 2010, and asthma requiring an albuterol inhaler. Vital signs at 1232pm revealed: blood pressure of 172/120, pulse of 64, and respiratory rate of 16 breaths per minute. Vital signs at 1242pm were 168/132, pulse of 62. Blood pressure at 1256pm was 190/110. EMS was offered to client but was declined, client was alert and oriented. No medications or interventions were indicated or administered. Client stated would follow-up with medical provider on own. At 1300 client and daughter left the site, reporting feeling fine, however, symptoms noted were not resolved. Client stated would go to Hospital for further evaluation as that is where medical records are.
60 2021-04-30 itchy skin 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 rash, shingles Rash on side of body shingles like; Rash on side of body shingles like; This is a spontaneous report... Read more
Rash on side of body shingles like; Rash on side of body shingles like; This is a spontaneous report received from a non-contactable consumer. A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 06Apr2021 14:00 as single dose for covid-19 immunization in pharmacy or drug store. The patient medical history and concomitant medications were not reported. No Pregnancy.Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included Covid-19 vaccine, dose 1 for covid-19 immunisation. The patient experienced rash on side of body shingles like on 10Apr2021 with outcome of not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained
60 2021-04-30 rash Fatigue and malaise. Then on 4/6/21 experienced intense skin sensitivity/pain (especially on back) ... Read more
Fatigue and malaise. Then on 4/6/21 experienced intense skin sensitivity/pain (especially on back) and chills, followed by a papule type rash on elbows, hands, fingers, back, and at the gluteal fold. Rash on fingers and back were also itchy. The rash had subsequently resolved, but it returned again accompanied by skin sensitivity/pain on my back along with nausea and lightheadedness on 4/29/21. It has not resolved as of this day.
60 2021-04-30 rash Rash; This is a spontaneous report from a non-contactable consumer (Patient) via Medical Information... Read more
Rash; This is a spontaneous report from a non-contactable consumer (Patient) via Medical Information Team. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 15Apr2021 (at the age of 60-years), as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient took 1st dose of COVID-19 VACCINE. On 16Apr2021 (one day after vaccination), patient had rash. Patient wanted to know if she can take Benadryl for the rash. Patient stated that she received documentation that this normally happened within an hour, and now this reaction occurred one day later and was asking about any information on side effects. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
60 2021-04-30 vaccination site pain Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Diz... Read more
Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Dizzy; Fatigue; Energy decreased; not feeling as much energy as before; Pain upon movement; walk about a block but then starts to hurt; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program, based on the information received by Pfizer (Manufacturer Control No: 21K-163-3774842-00). Solicited report from a consumer of a 60 year old female with events of heart/atrial flutter, atrial fibrillation, eye surgery and arm surgery and non-serious weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt with humira 40mg/0.4ml (adalimumab). The patient had a relevant medical history of tobacco use/four cigarette sticks per day, seropositive high titer rheumatoid arthritis, fingers swelling, joint pain, joint swelling and lost of blood flow in hands and legs. On unknown dates, the patient experienced eye surgery, arm surgery, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt. In 2020, the patient experienced heart/atrial flutter and atrial fibrillation. In Sep2020, the patient experienced weight gain due to attempting to stop smoking. On 24Feb2021, the heart/atrial flutter and atrial fibrillation resolved. Covid-19 vaccine was also considered suspect. The patient had eye and arm surgery in the past. On 24Feb2021, she underwent pulmonary vein cryoballoon ablation surgery for the atrial fibrillation and atrial flutter. She had a procedure done and went into her heart and froze the nerve endings that were causing the atrial fibrillation, and also fixed the flutter in her heart. The causality as per reporter for this procedure was reported as no reasonable possibility. She still recovering. She discontinued the Humira two weeks before the surgery and took her last injection on 10Feb2021 and was paused it for four weeks, but she started back it on 10Mar2021. She follows up with her surgeon at the end of the month and she hopes this helps got her off of the blood thinners and other medicines, she been on for this. She stated that this was not related Humira. She was advised by her physician to increase the exercise to lose some weight. With her lower back issues, she was hoping that when she got off of the blood thinners, she could do pain shots again and start exercise. She could walk about a block but then she started to hurt. She had been careful with her diet also, cut out the salt also. This had nothing to do with Humira and she did not want to be contacted about this again for this also. She felt fuzzy, it took her most of the morning to get woken up. Her Doctor thinks once she would off of the blood thinners she would be back to normal. Other than that she feels fine. She does not wanted to be contacted about this. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received first dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown. She agreed to have physician contacted. Blood thinner was also considered as co-suspect. Other medical history included abstains from alcohol, contrast dyes allergy manifested by scratch throat, allergy manifested by bowel movements (oral medications for rheumatoid arthritis; up to eight times a day and slept 15 hours per), prevent esophagus damage, heart, low thyroid, and attention-deficit/hyperactivity disorder. The patient's concomitant medications included pantoprazole to prevent esophagus damage, metoprolol for heart, levothyroxine for low thyroid, vortioxetine hydrobromide (TRINTELLIX) for depression, and dexamfetamine sulfate (DEXTROAMPHETAMINE) for attention-deficit/hyperactivity disorder. The patient underwent laboratory tests and procedures which included blood work: everything was fine in Jan2021; chemical stress test and treadmill stress test: confirmed atrial fibrillation and atrial flutter in Sep2020; body weight: gain in Sep2020; and X-ray: confirmed atrial fibrillation in Sep2020. The action taken in response to the events for adalimumab and apixaban was unknown. The patient recovered from atrial flutter and atrial fibrillation on 24Feb2021. Outcome of Feeling abnormal and Pain upon movement was unknown. The patient had not recovered from the remaining events. Change History: On 05Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, past drug information, laboratory/diagnostic procedures and narrative description. The events of "atrial flutter", "atrial fibrillation" and "weight gain due to attempting to stop smoking" were added. On 11Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "LOWER BACK ISSUES" and "WALK ABOUT A BLOCK BUT THEN STARTS TO HURT" were added. the event of "atrial flutter" was amended to "heart/atrial flutter". On 08Apr2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "felt fuzzy", "got first dosage of covid-19 vaccine and experienced sore arm", "fatigue and dizzy from the blood thinners after surgery" and "still not feeling as much energy as before" were added. Causality for humira 40mg/0.4ml(adalimumab): The reporter's causality for the event(s) of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood THINNERS after surgery unknown onset and fatigue and dizzy from the blood thinners after surgery unknown onset with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of felt fuzzy, still not feeling as much energy as before and walk about a block but then starts to hurt was not provided. Manufacturer opinion is that there is no reasonable possibility that the events of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery unknown onset, fatigue and dizzy from the blood thinners after surgery unknown onset, still not feeling as much energy as before and walk about a block but then starts to hurt are related to humira 40mg/0.4ml(adalimumab). The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information , the events of sore arm, fatigue and dizzy could be related to the suspected drug of BNT162B2. The other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
60 2021-05-02 injection site pain, injection site tingling, injection site numbness History of pain at injection site along with numbness/tingling with first dose. Doctor onsite approv... Read more
History of pain at injection site along with numbness/tingling with first dose. Doctor onsite approved to inject 2nd dose to thigh.
60 2021-05-03 redness, rash vesicular, itchy rash, rash with redness Client describes a tingling in her legs, feet and arms that started about 6-8 hours after receiving ... Read more
Client describes a tingling in her legs, feet and arms that started about 6-8 hours after receiving the shot. She also felt her face getting red and feeling hot and took Tylenol after going to bed. The next day, she had a rash on her forehead, scalp, neck, arms (elbows to hands) and ankles - red and a little itchy. She used soap and alcohol which had helped previously with other sensitive skin issues. This did not help for this and she starting using hydrocortisone cream, which helped some, but the rash returns. The rash which appears on her forehead has blisters.
60 2021-05-03 shingles Right facial itching/burning/tingling, swelling, redness, blurred vision; later found to have shingl... Read more
Right facial itching/burning/tingling, swelling, redness, blurred vision; later found to have shingles
60 2021-05-03 injection site redness, injection site warmth, injection site pain, injection site 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 injection site pain, skin discolouration, injection site swelling When the shot was administered into my left arm, I immediately felt pain down my left arm and into m... Read more
When the shot was administered into my left arm, I immediately felt pain down my left arm and into my left hand began to tingle. After waiting 15 minutes, my arm stopped hurting and my hand stopped tingling. At 3:00 AM 4/13/2021, I woke up to my left arm numb and a light purple color and my left hand was numb and my finger tips were tingling. I got a heating pad and placed the heating pad on my left arm, at the injection site, and then began to massage left hand and left arm. After 15 minutes my left hand stopped tingling and the numbness in my left arm stopped and the color to my left arm came back to the same color as my right arm. There is continued soreness and some swelling at the injections site of my left arm.
60 2021-05-03 injection site pain L.arm pain that began after receiving the vaccine and has persisted, now >5 weeks from vaccine admin... Read more
L.arm pain that began after receiving the vaccine and has persisted, now >5 weeks from vaccine administration. The pain is located in the L.upper arm but can move around. No redness, rash, heat, swelling, or other symptoms. No fever, chills, or sweats
60 2021-05-03 injection site pain Mild but noticeable shortness of breath occurred within an hour or two of receiving the vaccine. Not... Read more
Mild but noticeable shortness of breath occurred within an hour or two of receiving the vaccine. Not serious enough to seek medical attention. Subsided after about 4-5 hours. Arm soreness at the site for several days.
60 2021-05-03 injection site pain Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: syncope-Mild, Additional Details: Patient reported throat tightness and difficulty breathing. immediately after patient lost consciousness. patient was repositioned and one injection of epinephrine was given. paramedics came within 10 minutes and carted her off to hospital.
60 2021-05-03 itchy skin, rash 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 hardening, bruising, redness 1/7/2021 vaccination 1/8/2021 bruise/pain R lower leg, hard warm to touch. Painful and sore. Progre... Read more
1/7/2021 vaccination 1/8/2021 bruise/pain R lower leg, hard warm to touch. Painful and sore. Progressively got worse; red, bluer. 1/10 or 1/11 ER . Ultra sound on leg. 10cm clot. Put me on aspirin, warm compresses. Had to increase aspirin up to 2x day. It eventually cleared. Referred to surgeon. Found some other veins their inspecting further. *have not had any more clots
60 2021-05-04 rash Rash and hives on and around neck and chest and under chin.
60 2021-05-05 redness, cellulitis 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 2021-05-05 injection site redness Severe flu-like symptoms. Chills, fever, headach, body aches. Arm is red from vaccine site to almost... Read more
Severe flu-like symptoms. Chills, fever, headach, body aches. Arm is red from vaccine site to almost elbow. Very sore arm.
60 2021-05-05 injection site pain PAIN AT INJECTION SITE, BODY ACHES, CHILLS, FEVER, FATIGUE
60 2021-05-06 itchy skin, vaccination site redness, vaccination site pain 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 2021-05-06 rash rash spreading
60 2021-05-07 shingles Shingles.
60 2021-05-07 rash vesicular, blister started scratching and now the holes are open on areas to her chest; stated that the left side of he... Read more
started scratching and now the holes are open on areas to her chest; stated that the left side of her face is hard as a rock; Has rash on left side of face down to chest with blistery spots; could not breathe/cannot catch her breath every now and then; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 60-year-old, dose 1 via an unspecified route of administration, administered in right arm on 17Apr2021 (Lot Number: EW0171) as single dose for COVID-19 immunisation. Medical history included high blood pressure; and bad feet since 2004. The patient's concomitant medications were not reported. The patient had first vaccine on 17Apr2021. On 18Apr2021, she had a reaction, could not breathe. She cannot catch her breath every now and then and had to use the Epipen. Has been using nebulizer. Has more Epipens in case something else happened. Stated that she has a rash on the left side of her face down to her chest with blistery spots and that the left side of face was hard as a rock on 19Apr2021. Stated that the rash was worst on her chest. Has put some cream on the rash but it burns. Had a pain cream called Volten that she put on it because the rash was painful but that made it worst. Stated that she started scratching and now the holes are open on areas to her chest on 21Apr2021. Stated that she had to wear low shirts because her shirts were rubbing her chest. Stated that she was told by her doctor not to take the second shot that was scheduled for 17May2021. Stated that she has scheduled doctor's appointments that were fine. The patient wanted to know if she could get something in writing to submit with her passport stating the she could not have the second shot. The outcome of the event could not breathe/cannot catch her breath every now and then was recovered with sequel, and for the rest of the events was not recovered.
60 2021-05-07 vaccination site pain I started feeling worst anymore and woke up and my arm was sore; little sore onthe injection site; I... Read more
I started feeling worst anymore and woke up and my arm was sore; little sore onthe injection site; I started feeling worst anymore and woke up and my arm was sore; Rigorous, just shaking uncontrollably; Fever; profuse sweating; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 60-years-old female (non pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: en6201), dose 1 via an unspecified route of administration on 20Feb2021 13:30 (at the age of 60-years-old) as SINGLE DOSE for covid-19 immunization. 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. There was other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 to vaccination. Medical history included drug hypersensitivity, seasonal allergy, blood pressure increased, vascular device user from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had the Covid vaccine on Saturday afternoon and didn't feel anything. She was really impress the way it went. Sunday, on an unspecified date, she started feeling worst anymore and woke up and her arm was sore. It was not that big deal. Then by Sunday night on 21Feb2021 , she started to have a severe not chills but rigorous she meant just rigorous, just shaking uncontrollably and then her fever went up. This was same thing Monday and sweat so bad so profusely (on 21Feb2021). But it was such a violent reaction, she was wondering was that normal. She was enquiring that she should get second dose or what. She meant it was, she better today. She felt like she had been drunk to (statement incomplete). She had not none of today but that was terrible. She asked was that normal. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment for the adverse event rigorous, just shaking uncontrollably, fever and profuse sweating. The outcome of event i started feeling worst anymore and woke up and my arm was sore, little sore on the injection site was unknown. The outcome of rest event was not recovered. No follow-up attempts are needed. No further information is expected
60 2021-05-09 injection site pain, jaundice April 1, dark urine April 2, Fatigue, injection site pain dark urine April 3, Extreme fatigue, dark ... Read more
April 1, dark urine April 2, Fatigue, injection site pain dark urine April 3, Extreme fatigue, dark urine Jaundice went to urgent care, they advised i go to ER as they felt i needed an abdominal scan to see why i had so much bilirubin in my urine. Went to Hospital. CBC showed my hemoglobin was 5.9. Went down to 4.9 before first transfusionhad CT SCan and sonogram.. Was admitted and disagnosed with hemolytic Anemia brought on by Covid Vaccine. had 5 blood transfusions over the course of my 8 day hospital stay. As of 5/06/21 My hemogloblin is 10.3 and has been at this level for past three weeks, I am currently under the care of a hemotologist
60 2021-05-10 injection site swelling, itchy rash, injection site reaction Sore throat, fatigue, swollen itchy rash at injection site
60 2021-05-10 rash Fatigue; Started feeling sick again on 30Mar2021 and she could not move and ended up vomiting; start... Read more
Fatigue; Started feeling sick again on 30Mar2021 and she could not move and ended up vomiting; started feeling sick again on 30Mar2021 and she could not move and ended up vomiting; Vomiting/throwing up; Vomiting/throwing up; Rash; 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 at the age of 60 years old, administered in arm left on 29Mar2021 (Lot Number: ER8734) at single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus which diagnosed almost 10 years ago, obesity, sjogrens disease, knee replacements which done like 10 years ago on both knees and she did not know the exact dates of the knee replacements, asthma. Concomitant medications included loratadine taken for an unspecified indication from 13Mar2021 and ongoing; hydrochlorothiazide taken for sjogrens disease from an unspecified start date and ongoing; fluoxetine taken for an unspecified indication as antidepressant from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTEC) taken for asthma from an unspecified start date and ongoing; montelukast sodium (SINGULAIR) taken for asthma from an unspecified start date and ongoing. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 60 years old, administered in arm left on 08Mar2021 (Lot Number: EN6206) for covid-19 immunisation, and experienced sickness to her stomach, fibromyalgia flared up, heaviness in the muscle of her arm and vomiting within 24 hours after the vaccination. The patient also previously took shingles shot for immunization. The patient experienced vomiting/throwing up on 30Mar2021, rash on 30Mar2021, fatigue on an unspecified, started feeling sick again on 30mar2021 and she could not move and ended up vomiting on 30Mar2021. After the 2nd dose within 24 hours the patient started feeling sick again on 30Mar2021 and she could not move and ended up throwing up and got a rash that appeared on her left arm; stated she had both doses of the Pfizer COVID Vaccine in her left arm and the rash is a little above where the vaccine doses were administered. She had the 2nd Pfizer COVID vaccine on 29Mar2021 and has been coming in and out of feeling good and bad since then and for the rash she has she used the Triamcinolone Acetone cream and the rash seems to subside and then flares back up and when the rash flares back up she gets sick again. Stated the Triamcinolone Acetone cream is 0.1% with lot 0LT0435, expiry date Sep2022. She just got over this this weekend and was sick on Friday, was ok on Saturday and then on Sunday she could not move and was sick. The rash had gotten larger than when it first appeared and when it does flare it itches and was hot and she also has Sjogrens disease in that rheumatology thing and has had the shingles shot 2 years ago; states she has no name of the shingles shot to provide but had it 2 years ago in September. The patient stated this was not shingles and she had the shingles shot and this does not look like shingles to her. She stated she takes several different asthma medicines (cetirizine hydrochloride and montelukast sodium) and made the reported event not as severe and the rash is not as severe. The outcome of the event rash was not recovered, of the other events was unknown. No follow-up attempts are needed. No further information is expected.
60 2021-05-10 hives Same-day reactions -within 5 minutes: hives in face and neck - a few more minutes later: swollen li... Read more
Same-day reactions -within 5 minutes: hives in face and neck - a few more minutes later: swollen lips (had to take Benadryl and 20 mg of prednisone that I was carrying because the hospital only had the epipen) - within 24 hours: shortness of breath, palpitations - couple of days later: admitted to the ER with pneumonia and PVC arrhythmia
60 2021-05-10 vaccination site pain pain in her right arm; there is pain in her right breast and under arm.; there is pain in her right ... Read more
pain in her right arm; there is pain in her right breast and under arm.; there is pain in her right breast breast and under arm; there is pain in her right breast breast and under arm; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for 60-year-old female patient (reporter wife) that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) On 07Apr2021 administered at right arm as a single dose for COVID-19 immunization. The past medical history and concomitant medication was not reported. On 07Apr2021, patient had experienced pain in her right arm where she received the vaccine. Patient reported that she could hardly lift up the arm because of the pain, there is pain in her right breast breast and under arm. The patients second dose was due today 29Apr2021 but she did not want to get it because of the pain. Patient is going to see an MD tomorrow for treatment. The clinical outcome for the events were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
60 2021-05-11 shingles, rash Shingles - intense internal left abdominal and side pain, followed by skin rash on left side a week ... Read more
Shingles - intense internal left abdominal and side pain, followed by skin rash on left side a week later. Treated with pain medication, and anti-virus medication. Still experiencing some pain and some rash 2 months later, at the time of this report. Currently continuing pain medication.
60 2021-05-11 injection site pain, injection site swelling March 31, 2021 - second injection was given left arm top and slightly right-not centered in the delt... Read more
March 31, 2021 - second injection was given left arm top and slightly right-not centered in the deltoid muscle. I yelled, "Ouch," when given the injection because it was very painful.. Since then, my left shoulder has been swollen and painful. The pain keeps me up at night so I am not getting the needed sleep. I sometimes wake up in excruciating pain from sleeping on my left arm, which although I try not to, it's my normal sleeping position. I feel pain throughout the day and my arm range is limited. May 12, 2021 - treatment is ice 5-minutes a day; aspercreme with lidocaine, arm movement exercise and Alleve.
60 2021-05-11 itchy skin, vaccination site itchiness throat closed up and my tongue feels thick; throat closed up and my tongue feels thick; I couldn't ... Read more
throat closed up and my tongue feels thick; throat closed up and my tongue feels thick; I couldn't swallow; severe itching in the shot area; severe itching in chest area; 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: EW0170) via unspecified route on right shoulder (right arm) unknown single for COVID-19 immunization on 23Apr2021 at 60-year-old. Medical history and concomitant medication were not reported. 15 minutes after the patient took the shot (23Apr2021), patient throat closed up and tongue felt thick, the patient couldn't swallow but the patient was medical services at the bin where the patient had the shot. After about 30 or 40 after minutes (23Apr2021), maybe 30 minutes after the shot, the patient started doing lot of itching, severe itching in the shot area in the shoulder in chest area, severe itching was given some diphenhydramine hydrochloride (BENADRYL) and it did a help so but still had itching in chest area. Outcome of the event severe itching in chest area was not resolved, outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.
60 2021-05-12 itchy skin, rash with redness, injection site pruritus, injection site reaction 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 2021-05-13 itchy skin, blister, hives, skin peeling, rash macular 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 2021-05-13 vaccination site pain Arm pain at site of injection; This is a spontaneous report from a contactable consumer. A 60-years-... Read more
Arm pain at site of injection; 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), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 15:30 (Lot Number: EL9269, Expiration date: unknown, at the age of 60-years-old) as first dose, single dose for covid-19 immunisation. Medical history included ongoing hypothyroid. No known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported and supplements (vitamins). No covid prior vaccination. Covid not tested post vaccination. The patient experienced arm pain at site of injection on 23Feb2021 20:30. No treatment was received. The outcome of the event was not recovered.
60 2021-05-14 rash, itchy skin severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, sev... Read more
severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, severe itching and rash; 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: ER8732), dose 2 via an unspecified route of administration, administered in arm left on 22Apr2021 12:30 as 2nd dose, single for covid-19 immunisation. Medical history included fibromyalgia, ongoing diabetes type2, non-Alcoholic Cirrhosis, ongoing Chronic fatigue syndrome (CFS), spinal degeneration, hypo thyroid, gallbladder removal, hernia repair, hysterectomy, restless leg syndrome, sleep apnea, Known allergies with Wellbutrin, Naltrexone, tape. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198) administered in arm left on 23Mar2021 12:30 for COVID-19 Immunization. The patient reported to ER with severe swelling of lips and tongue, severe itching and rash on 30Apr2021 09:15. The adverse event result in emergency room/department or urgent care. The patient received treatment (IV of Solumedrol and Benedryl) for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Covid test post vaccination with Nasal swab and result was negative. The outcome of the events was resolved with sequelae.
60 2021-05-15 injection site swelling, injection site pain starting 1st day of injection pain at injection site and radiating up to shoulder with swe... Read more
starting 1st day of injection pain at injection site and radiating up to shoulder with swelling around the site area. Nausea . starting days 2 & 3 pains increased up further on left side of the arm to neck (left side only) , switched from taking Ibuprofen 800mg throughout the day after day 3 - 4 body aches and pains in left leg/thigh muscles , switched to Tylenol 1000mg everyday from day 1 rubbing down multiple time daily with rubbing alcohol , nightly alcohol with Epsom bath soaks. pains for about 2 weeks before relief. May 11 no pain just still tiredness . Yesterday and today believe all resolved .
60 2021-05-15 itchy skin, rash, redness Redness, rash getting bigger, itchy. applied hydrocortisone/eucerin cream combo (5/16/21) helped wit... Read more
Redness, rash getting bigger, itchy. applied hydrocortisone/eucerin cream combo (5/16/21) helped with itch
60 2021-05-15 itchy rash, rash Joint pain lasting 30 days, rash on ALL parts of body starting one week after 2nd dose STILL active,... Read more
Joint pain lasting 30 days, rash on ALL parts of body starting one week after 2nd dose STILL active, itching, painful. Steroid pack and cream used with no results.
60 2021-05-16 shoulder injury related to vaccine administration Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
60 2021-05-16 hives 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 rash she had a fever of 101F (her normal body temp is 96.8F); rash on her forehead; little pustules; head... Read more
she had a fever of 101F (her normal body temp is 96.8F); rash on her forehead; little pustules; headache; little trouble breathing; This is a spontaneous report received from a Pfizer sponsored program via a contactable consumer (patient) reported for herself. A 60-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown, Expiry date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was 60 years) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included she had an anaphylactic reaction twice in her life, once to macadamia nuts, and once to "an allergy shot with dust stuff in it". She had a complicated allergy history. Also reported allergies to corn and Benadryl and allergic to an ingredient in benadryl, originally reported as "polypropylene glycol", but later corrected to "polyethylene glycol". The patient was allergic to corn and poly-something in BENADRYL so she couldn't take it anymore. Co-suspect medication included diphenhydramine hydrochloride (BENADRYL). She stated that after the first dose, she had fever of 101F (her normal body temp is 96.8F), a rash on her forehead, and a headache, and noted that on the second day she 'had a little trouble breathing' but said it might be from seasonal allergies. Pretty normal reactions- her normal body temperature was 96.8F had a fever of 101F that's one of the regular side effects and a little bit of a problem breathing- on the second day. Rash on forehead right away, headache too. kept a cold compress and kept switching it every couple of minutes b/c of the fever little pustules. When she put the cloth on regularly it soaked her skin. Rash went away after she had 2 anaphylactic rxn - macadamia nut & allergen shot that had dust stuff in it. She treated the fever and forehead rash with cool compresses and kept switching it every couple of minutes, putting the cloth on regularly it soaked in skin and noted that the rash had what appeared to be 'little pustules" and thought the rash may have been caused by the fever because they resolved at the same time. She had a side effect after the first dose of the vaccine. She asked whether she could receive the second dose and whether she should get the second dose. The nurse that gave her husband his shot said that the reactions to the second dose were more severe. She received the response stating that provided contraindications and discussed potential signs and symptoms of severe allergic reaction as listed in 'CONS-what are the risks of the vaccine (v5.0)' and when they would expect them to occur. Confirmed that fever was commonly reported and that common AEs were more frequently reported after dose 2 in clinical trials (Tables 1-4). Referred caller to her HCP or vaccination site for additional guidance and monitoring. Confirmed that polyethylene glycol is an ingredient in the Pfizer Covid19 vaccine. She should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They referred her to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Her healthcare provider knew her health situation and had access to information that can better help inform that decision. The caller was unsure if she should take 2nd dose of COVID vaccine. Bendadryl no longer Pfizer but unclear when she developed allergy to it. The outcome of events she had a fever of 101F (her normal body temp is 96.8F), rash and little pustules was recovered on an unknown date. The outcome of the events headache and little trouble breathing was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Follow-up (16Apr2021): New information received from a Pfizer-sponsored program via a contactable consumer (patient) reported for herself included: Added Benadryl as co-suspect medication.
60 2021-05-17 hives, itchy skin 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 2021-05-17 hives hives; This is a spontaneous report from a contactable physician via Pfizer sponsored program. A... Read more
hives; This is a spontaneous report from a contactable physician via Pfizer sponsored program. A 60-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation Solution for injection, Lot Number unknown, Expiry date: 31Jul2021) via an unspecified route of administration on 20Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 20Apr2021 patient Stated that hives experienced almost immediately after receiving the first dose Pfizer Covid Vaccine. Outcome of the event was recovered. Follow-up attempts are needed. Further information has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, urticaria cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate.
60 2021-05-18 itchy skin, rash 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 2021-05-18 itchy rash Numbness; Headache; Dizziness; extreme fatigue; muscle aches; she saw white flashes in front of the ... Read more
Numbness; Headache; Dizziness; extreme fatigue; muscle aches; she saw white flashes in front of the eyes; She got some bumps that are itchy on the ankle; Bell's palsy; facial paralysis; Lyme disease/had a bunch a symptom and flare up; Lyme disease/had a bunch a symptom and flare up; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 15Apr2021 12:00 (Batch/Lot Number: EW0158) at single dose for COVID-19 immunisation. Medical history included High Blood pressure, Chronic Lyme's Disease, Rocky mountain spotted fever, Psoriasis. She had Bells Palsy with her Lyme's disease 15 years ago. She also added that she was diagnosed about a year with rocky mountain spotted fever. Lyme's disease and rocky mountain spotted fever are both tick born diseases. She also had Bells palsy with the rocky mountain spotted fever. She had mild psoriasis, once a year she got little spots on both arms little patches of skin that were scaly, other then shots been. Concomitant medications included routine blood pressure medication .Patient stated she reported the side effects to the nurse on the other line. she wanted to know if you have information on the vaccine given to individual with Lyme disease. she received the first shot of the Pfizer COVID-19 shot on 15Apr2021. she had a bunch a symptom and flare up. she had facial paralysis which began 24 hours after receiving the vaccine. she worried about getting my second shot. Patient also wanted some clarification on the reported Bell palsy post vaccination. Patient stated that she was calling about the covid vaccine, she had had chronic Lyme disease for a long time and when she got the vaccine it triggered a lot of old symptoms. She was trying to call doctor and health department. She was scheduled for the second dose on this coming Monday 03May2021. She wanted to question if there was research on people with Lyme's diseased. The symptoms she experienced was bells palsy, noticeable numbness in lips to nose to cheeks that occurred about an hour and a half after shot, the bells ballsy was in the center of her face clarifying on both sides of the face. She spoke for a living and her face went numb that didn't make sense. She also still had a headache for 2 weeks every day, she saw white flashes in front of the eyes, some dizziness, extreme fatigue, and muscle aches. She also went to the chiropractor once a week for back pain and it hadn't been helping. The Chiropractor said that a bunch of patients have been complaining since the shot that the chiropractic wasn't working as well. She got some bumps that are itchy on the ankle, no bugs are outside yet, it's a couple itchy bumps, she didn't know if it's related. Patient clarifies that the bumps she had was 1 on ankle and 1 on hip, and 1 below belly button, it started a couple days ago. No follow-up attempts are needed. No further information is expected.
60 2021-05-18 rash, scab, blister After 1 shot had doctor appt and was notice that my kidneys function has declined slightly, then 7 ... Read more
After 1 shot had doctor appt and was notice that my kidneys function has declined slightly, then 7 days after the second shot I notice these blisters on my right lower leg near ankle filled with clear liquid it was a rash of multiple blisters. After about 7days they begin to go down I did not try to pop them I just took pictures each day and now they have went down today is May 19th 2021. and the area has dark scabs that seem to be going away.
60 2021-05-19 itchy rash, rash with redness, rash Pt says she started getting red, round, flat, itchy marks on her skin that looks like bug bites. If... Read more
Pt says she started getting red, round, flat, itchy marks on her skin that looks like bug bites. If she scratches them they start to whelp. They are on her forearm, left hand on the upper part of her thumb, forehead and ankle that are itchy. There are a couple on the inner part of her thighs that are not itchy. She uses alcohol wipes to help with itch. On 5/18/21 pt went to her PCP. She was told to report her symptoms to us.
60 2021-05-19 vaccination site pain, vaccination site warmth, vaccination site redness, vaccination site rash about 1+ hours ago, she came down with a massive headache; it as a "bright, red, rashy and blotchy"/... Read more
about 1+ hours ago, she came down with a massive headache; it as a "bright, red, rashy and blotchy"/her (left) arm was bright red with a (blotchy) rash (across her left arm); it was "hot as hell"/her (left) arm was hot as hell; She had a blotchy rash across her left arm; She had injection site soreness for 3 days after receiving her first COVID-19 Vaccine; couldn't move her arm at all; left arm was a little tender to move; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in left arm on 27Apr2021 (lot number: EW0171) at single dose for COVID-19 immunization. The relevant medical history included ongoing multiple allergies, ongoing peanut allergy, ongoing reaction to sulfites (sulfites in wine gave her a headache), ongoing reaction to preservatives (She said she would become anxious & then turn bright red & become short of breath. She said sometimes her tongue would turn pale & white looking & she would faint. She said she carried Benadryl with her & the Benadryl took care of her reactions. She said Benadryl had been her "MO" for treating reactions. She said the doctors don't want to give her an EpiPen unless her reaction is a documented as an anaphylactic reaction) and sensitive to the epinephrine (used in dental treatments caused her to become short of breath, and faint). Concomitant medications included potassium acetate from Apr2021 and ongoing for an unspecified indication. The patient previously took Benadryl from unspecified date to treat her peanut allergy and won't help her allergic reaction to peanuts; also took Benadryl from unspecified date for reaction to preservatives. The patient said that 8 days after the injection, she experienced a massive headache and the left arm where she received the vaccine had a red "circle" around the injection site. She described it as a "bright, red, rashy and blotchy" and said it was "hot as hell". She explained her son and husband were vaccinated right after her, by the same person, and they didn't develop anything. She explained she thought her reaction was due to the preservative in the vaccine as she had a lot of allergies. She expressed her concern about potentially developing anaphylaxis to the second dose of the vaccine after her reaction to the first. She asked for the risk associated with taking the second dose of the vaccine after such reaction to the first. The nurse furtherly reported that about 1+ hours prior to the report (clarified as the time of the report, 06May2021), she came down with a massive headache. She said her husband brought her home something for her headache. She said her (left) arm was bright red with a (blotchy) rash (across her left arm). She said her (left) arm was hot as hell. Reported she had a hesitation to take the COVID-19 Vaccine because she had a lot of allergies to begin with, but nothing that caused an anaphylactic reaction. On 27Apr2021, she had injection site soreness for 3 days after receiving her first COVID-19 Vaccine and her left arm was a little tender to move at that time, but not as bad as after receiving a TB (vaccine) shot. She said after the TB vaccine shot, she couldn't move her arm at all. She reported her symptoms came out of nowhere, and she believed her headache and left arm rash were directly related to the COVID-19 Vaccine. She said her son and husband went immediately after her for their COVID-19 Vaccines, and had the same exact person administer the COVID-19 Vaccine. She said neither her son, nor husband, had a reaction from the COVID-19 Vaccine. No further details provided. The events did not require a visit to Emergency Room or Physician Office. Treatment for headache included 1 Extra Strength Tylenol 500mg caplet. Treatment for left arm blotchy rash included a cold compress on her left arm. She said she also took Benadryl (clarified as Walgreens Children's Dye Free liquid "Wal-Dryl" Diphenhydramine). She said she preferred to use the children's liquid Diphenhydramine because when she had a reaction, sometimes her throat felt like it was swelling. The outcome of the event left arm was a little tender to move and couldn't move her arm at all were recovered on an unspecified date, for event injection site soreness for 3 days after receiving her first COVID-19 Vaccine was recovered in Apr2021, while the other events were not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events headache, Vaccination site erythema, Vaccination site warmth, and Vaccination site rash and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
60 2021-05-20 blister First vaccine on April 5th, 24 hours later I had painful blisters in my chest Second vaccine on Apr... Read more
First vaccine on April 5th, 24 hours later I had painful blisters in my chest Second vaccine on April 26. Had no immediate symptoms but on May 13 I started having pain in my gums, then severe canker sores all over my mouth. Could not eat, sleep or talk. I thought it was mouth infections and went to see my dentist but I was told they were canker sores. He thought it was unusual to have that many especially when I had not diet change, eat home cooked meals, with normal stress level. He asked about the vaccine. Later I googled on the internet and found out other Pfizer patients had same reaction.
60 2021-05-21 rash macular, redness, hives, itchy skin I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of th... Read more
I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of the steps when you getting to walk down the stairs; Severe allergic reaction; I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of the steps when you getting to walk down the stairs; My body was red and I had blotches bumps all over me my back under my right breast; My body was red and I had blotches bumps all over me my back under my right breast; My entire body was inflamed; Started getting hives on my back, under my right breast, both arms and both legs and thighs and I started getting bump. I broke out in hives in sleep in middle of night; I woke up out of my sleep in the middle of the night like the wee hours of the morning itching; I had like difficulty breathing; I had severe headache and I had it like all week; severe headache; My pressure went up like 140 over 100; high blood pressure; This is spontaneous report from a contactable consumer (Patient herself). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0172), via an unknown route route on 04May2021, as a single dose, for COVID-19 immunization. Patient's medical history included seasonal allergy (using an inhaler), Asthma and Diabetes. The patient's concomitant medications included insulin. On the same day of vaccination on 04May2021, at the first hour, the patient had a severe allergic reaction. The patient also experienced severe headache and I had it like all week and her pressure went up like 140 over 100 and then like the next day you know I had like difficulty breathing. On the third day, The patient also had a severe allergic reaction. The patient stated that her entire body was inflamed and then she started getting hives on her back, under the right breast, both arms and both legs and thighs. The patient also experienced bumps. The patient further stated that she had dizziness and was going to pass out when she had to walk down the stairs. The patient also stated that she broke out in to hives in her sleep in the middle of the night. The patient had itching at the wee hours in the morning. The patient stated that she went and looked in the mirror and her body was red and I had blotches bumps all over her back under my right breast. The patient wanted to know whether she can take the second shot. The patient asked whether the vaccine was going to affect her and if so, she cannot take it. Patient was supposed to take the second shot on 26May2021. The patient did not had any physician visit for the events. The patient used Benadryl as treatment medication for the events. The patient asked whether the vaccine was going to affect her and if so, she cannot take it. Patient was supposed to take the second shot on 26May2021. The outcome of the events was unknown. Information about batch/lot number was available. Further information was expected.
60 2021-05-22 rash, shingles, scab Shingles. Right arm, hand, shoulder Was given antiviral medication, lidocaine cream, pain medication... Read more
Shingles. Right arm, hand, shoulder Was given antiviral medication, lidocaine cream, pain medication for 14 days. As of 4/23/2021 symptoms of rash, scabbing, burning sensation still present.
60 2021-05-23 injection site pain, injection site redness, injection site hardening, injection site pruritus, injection site swelling Swollen injection site, red itchy, hard, painful. Whole arm pain. Tylenol and also Benadryl at nigh... Read more
Swollen injection site, red itchy, hard, painful. Whole arm pain. Tylenol and also Benadryl at night.
60 2021-05-23 injection site pain Sore arm on injection site. Next day, headache, body aches and tired for about 3 days. Twitch in lef... Read more
Sore arm on injection site. Next day, headache, body aches and tired for about 3 days. Twitch in left eye from day 2 and still happening. No treatment needed medically so far.
60 2021-05-23 rash, itchy rash Severe Puritic Body Rash that started as Pustules and progress to full blown Cellulite to Boils. Ra... Read more
Severe Puritic Body Rash that started as Pustules and progress to full blown Cellulite to Boils. Rash over upper 1/3 of body and arms as well as buttock lesions and Left foot. No Sleep from 5-6-2021 to today 5-24-2021. Atarax and Steroids and Antibiotics have not helped.
60 2021-05-24 itchy skin Pt reported itching all over the body about 5-10mins after the vaccine. I gave her 25mg of Diphenhyd... Read more
Pt reported itching all over the body about 5-10mins after the vaccine. I gave her 25mg of Diphenhydramine solution by mouth immediately and asked her to monitor the symptoms and let us know. She mentioned she has Lupus and is not on any drugs for it right now. Other pharmacist called her Dr and the patient herself called Dr to report the reaction. Dr sent a prescription for Prednisone 10mg and she took 2 tabs right away.
60 2021-05-25 injection site pain Headache, Myalgia, Fever, INJECTION SITE PAIN
60 2021-05-25 rash Tongue swelling, facial numbness, rash to both arms, tachycardia, headache, eye pain, elevated b/p 2... Read more
Tongue swelling, facial numbness, rash to both arms, tachycardia, headache, eye pain, elevated b/p 210/103, dizziness, and shaky. Epinephrine given with relief of swelling within 20 min. Two hours later reports vomiting and diarrhea.
60 2021-05-25 hives, shingles 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 2021-05-25 vaccination site pain Injection site pain; Nausea; Fever (unknown temperature); Chills; Body aches; Bad headache; This is ... Read more
Injection site pain; Nausea; Fever (unknown temperature); Chills; Body aches; Bad headache; This is spontaneous report from contactable consumer, the patient. A 60-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3248), dose number 2, via an unspecified route of administration in the right arm on 15Mar2021 at 01:00 PM, (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown, whether the patient was diagnosed with COVID-19, prior to vaccination. Since the vaccination the patient was not tested for COVID-19. The patient had no current illness. Past drug history included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3248), dose number 1 via an unspecified route of administration in the right arm on 22Feb2021 at 01:15 PM, as a single dose for COVID-19 immunisation. Medical history included allergy to ibuprofen and breast cancer. Concomitant medications included daily vitamin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), 81 mg aspirin (MANUFACTURER UNKNOWN) all for unknown indication. On 15Mar2021 at 01:00 PM, the patient experienced bad headache, body aches, fever (unknown temperature), chills, nausea and injection site pain. The injection site pain was minimized. No therapeutic measures were taken for the events. The clinical outcome of bad headache, body aches, fever (unknown temperature), chills and nausea were unknown. The clinical outcome of injection site pain was resolving. Action taken with BNT162B2 was not applicable No follow-up attempts are needed. No further information is expected.
60 2021-05-26 eczema, itchy skin, redness It's like eczema in skin/patches like an eczema; Itchy; little blots of red; Allergic reaction; Pain... Read more
It's like eczema in skin/patches like an eczema; Itchy; little blots of red; Allergic reaction; Pain Whole Left arm; Headaches; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Deltoid Left on 03Apr2021 12:00 (Lot Number: EN6198) as 1st dose, single, and via an unspecified route of administration, administered in Deltoid Left on 24Apr2021 12:00 (Lot Number: ER8737) as 2nd dose, single for COVID-19 immunization. Medical history included Crohn's disease and immunodeficiency from an unknown date. The patient is not on other medication and doesn't take anything. On 04Apr2021, the next day after vaccination of the first dose, the patient had pain whole left arm and headaches and took Tylenol. On 05Apr2021, patient experienced it's like eczema in skin/patches like an eczema, little blots of red, that is really itchy, and allergic reaction. The patient took an antihistamine. On 25Apr2021, after the second dose, the patient again had pain whole left arm and headaches and on an unspecified date after the second dose had the same patches like an eczema not clearing still itching. Patient was still taking antihistamine. No emergency room and physician's office visit was done. The outcome of the events was not recovered.
60 2021-05-26 redness, itchy skin Exhaustion; Red itchy arm; Red itchy arm; This is a spontaneous report from a contactable consumer, ... Read more
Exhaustion; Red itchy arm; Red itchy arm; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-Sponsored Patient Support Program. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6201), via an unspecified route of administration in the right arm on 12Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included allergies (had a reaction to a lot of things in life), headaches since she was about 12 years old, supraventricular tachycardia, cardiac loop which died, normally had abnormally low blood pressure her whole life (normally 98 would be high and 58-60 as the bottom number would be normal). Concomitant medications were not reported. On 12Mar2021, the patient experienced red itchy arm. After the vaccination, she was told to sit in the sitting area because she had an unspecified underlying condition and had a reaction to a lot of things in life, just allergies basically. The patient's arm was red. Within a couple minutes and all of a sudden, she had streaks down it and it started getting very itchy. The red, itchy arm lasted about half an hour. On 13Mar2021, the patient experienced heavy duty exhaustion for a week - she thought she was just tired from stress. The clinical outcome of "red itchy arm" was resolved on 12Mar2021, of exhaustion was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021539682 same patient, different dose number and event
60 2021-05-26 rash 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 skin warm, redness developed cellulitis with right breast. I am 2 years post radiation for right breast cancer. No tra... Read more
developed cellulitis with right breast. I am 2 years post radiation for right breast cancer. No trauma has occurred this year to right breast. Area of radiation of right breast became red hot weeping with an unknown abscess that developed internally in the area of right breast where cancer was. This area was treated with 2 round of antibiotics with out being fully cleared up. New area of redness has developed again in the right breast yesterday 5/26/21. Another round of antibiotics will be started today. The only introduction of anything placed on body or skin is the vaccine.
60 2021-05-27 blister Pt had first COVID19 vaccine at Pharmacy on 5/25/2021. It was Pfizer vaccine. Pt came in to see me o... Read more
Pt had first COVID19 vaccine at Pharmacy on 5/25/2021. It was Pfizer vaccine. Pt came in to see me on 5/26/2021 with blisters on right great toe, right 2nd toe. Painful only secondary to wearing shoes. Pt has good pulses and trace edema bilaterally which is normal for her. Pt reports the blister on her right great toe appeared on 5/26/2021 and the blister on right 2nd toe appeared on 5/27/2021
60 2021-05-27 itchy skin, redness, skin warm Redness, swelling, itchy, heat
60 2021-05-28 skin burning sensation, rash, itchy skin 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 2021-05-28 vaccination site pain aching all over; her arm hurt very bad where she got shot, right arm, "her arm was killing her; shoo... Read more
aching all over; her arm hurt very bad where she got shot, right arm, "her arm was killing her; shooting from her arm up to her neck; chills; feeling really unwell; heart started beating a little bit fast; shortness of breath; tiredness; headache; muscle pain; joint pain really bad; really weak; Back Pain; Throat Hurting; injection site pain; 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: EP7533), via an unspecified route of administration in the right arm on 12May2021 08:30 (at the age of 60-year-old) as single dose for COVID-19 immunization. Medical history included allergic to dye (last time she had black dye, her head was itching and burning like fire and her head is still red and her hair is falling out by handfuls), back injury ongoing since 2004, and ongoing diabetes mellitus that started 14.5 years ago. The patient was tested negative on the COVID Nasal swab on 08Nov2020. The patient was hospitalized for 7 days for COVID-19 from 07Feb2021 or 08Feb2021 when she had "diarrhea coming out both ends", and when she had come home, she had on/off head spinning for 2 weeks and in a month her head stopped spinning. She waited 90 days before getting the vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not enrolled in a clinical study or a program. Concomitant medications included naproxen (NAPROSYN E) taken as needed for back pain. On 12May2021, the patient experienced injection site pain. On 13May2021, she started experiencing aching all over for about 8 hours and has been hurting all morning from 08:00, "her arm hurt very bad where she got shot, right arm", "her arm was killing her; shooting from her arm up to her neck", tiredness, couldn't hardly walk legs were hurting started today worse, headache, muscle pain, really bad joint pain, chills, feeling really unwell, really weak, heart started beating a little bit fast and shortness of breath. she has no swollen lymph nodes. She stated her back wasn't hurting yesterday and now today (13May2021) she has back pain so much so that she can't hardly get out of bed. She also stated throat hurting. She reported that the persistent/significant aching all over for about 8 hours & "her arm hurt very bad where she got shot, right arm" were serious due to disability/incapacity. If it keeps up like this, she doesn't know if she will take the second one. She is scheduled for her second one on 02Jun2021. Later, she stated, "I was aching about 8 hours. After that I think I had took a Tylenol" but she can't be sure. The clinical outcome of the event "aching all over" was resolved after 8 hours on 13May2021 around 16:00. The clinical outcomes of the events chills and heart started beating a little bit fast were resolving, the events injection site pain, "her arm hurt very bad where she got shot, right arm", "her arm was killing her; shooting from her arm up to her neck", tiredness, headache, muscle pain, joint pain really bad, really weak, throat hurting were not resolved, while the events feeling really unwell, shortness of breath and back pain were unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
60 2021-05-28 vaccination site rash, vaccination site pain, vaccination site redness Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The ra... Read more
Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; This is a spontaneous report from a contactable consumer(patient). This 60-year-old (non pregnant) female Patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: unknown), via an unspecified route of administration in the left arm, on 26Jan2021 at 08:00 (at the age of 60-year-old), as single dose, for COVID-19 immunization, in the hospital. Medical history included Penicillin allergy from an unknown date and unknown if ongoing. Patient had no other known illnesses. The first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number EK5730, Expiration date was not reported), received via an unspecified route of administration, administered in left arm on 05Jan2021 at 13:00 for COVID-19 immunization. Concomitant medication was not reported. Prior the vaccination, was not diagnosis with COVID-19.post vaccination, no COVID test was performed. On 29Jan2021 at 6:00, patient experienced Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 postinjection. No treatment was received for the events. The outcome of the events was reported as not recovered. Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
60 2021-05-30 itchy rash, psoriasis Outbreak of psoriasis with rash and severe itch - I don't think the vaccine caused the psoriasis but... Read more
Outbreak of psoriasis with rash and severe itch - I don't think the vaccine caused the psoriasis but it may have made it spread more or quicker. If this has happen to others with psoriasis, than maybe a warning should be given, so an informed decision can be made for future doses.
60 2021-05-31 injection site inflammation, injection site redness, injection site warmth Two days following the first dose of the Pfizer vaccine, the patient developed redness around the in... Read more
Two days following the first dose of the Pfizer vaccine, the patient developed redness around the injection site that was hot to the touch. The redness/inflammation did grow to a larger area than just the injection site. I counseled on icing and treating with tylenol, ibuprofen, or benadryl and reporting back if the inflamed area continued to expand to a larger portion of her arm.
60 2021-05-31 itchy skin Watery itchy eyes; Watery itchy eyes; Itchy nose; itchy nose and throat; itchy head, neck, and body;... Read more
Watery itchy eyes; Watery itchy eyes; Itchy nose; itchy nose and throat; itchy head, neck, and body; headache; Tiredness; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received first single dose of BNT162B2 (lot Number: PFIZER BION TECH MANUFACTURING) via an unspecified route of administration into left arm on 13Mar2021 at 09.30 AM for COVID-19 Immunisation. Medical history included allergy to salmon, carbamazepine (TEGRETOL), ketorolac tromethamine (TORADOL), lithium, morphine (MORFINE), nova cane, ciprofloxacin (CIPRO), Sulfa, hyoscyamine sulfate methenamine methylthioninium chloride phenyl salicylate phosphoric acid sodium (URELLE), and contrast media allergy. Prior to vaccination patient was not diagnosed with covid-19, and since the vaccination the patient had not been tested positive for COVID-19. Concomitant medications were not reported. The patient experienced watery itchy eyes, itchy nose and throat, itchy head, neck, and body, headache and tiredness on 13Mar2021 at 09.45 am. The adverse events resulted in doctor or other healthcare professional office/clinic visit]. The patient was administered with 2 diphenhydramine hydrochloride (BENADRYL) as a therapeutic measure on an unspecified date. The patient was recovering from all the adverse events at the time of reporting. No follow-up attempts are needed. No further information is expected.
60 2021-06-01 rash, redness Within 10 days of dose one, severe outbreak rosacea or rash-like effect on face: hot, red and bumpy.... Read more
Within 10 days of dose one, severe outbreak rosacea or rash-like effect on face: hot, red and bumpy. Had to see MD for treatment. Also after #2 dose, lot EW0161 given 05/24/2021, same symptoms developed after 7 days from shot date. Again saw doctor this time for treatment.
60 2021-06-01 rash Chills and fever; Chills and Fever/Fever has gotten better went from 103to99; Broke out in rash; Thi... Read more
Chills and fever; Chills and Fever/Fever has gotten better went from 103to99; Broke out in rash; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), dose 2 via an unspecified route of administration, administered in right arm on 18May2021 at 08:30 as single dose for covid-19 immunization. Medical history included breast cancer from 19Jun2019. She had surgery in Jul2019, a lumpectomy and they did radiation on her left breast in Sep2019 and Oct2019 then she went into remission. The patient's concomitant medications were not reported. No prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. The patient previously received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number: unknown) in right arm on 27Apr2021 at 08:30 (at the of 60-year-old) as single dose for covid-19 immunization. She got the shot on Tuesday. When she got her shot she did not start having a reaction until Thursday night. Then Thursday 20May2021 until 22May2021 not having chills anymore, running low grade fever. She had chills and fever on 20May2021 around 5:00 to 6 in the evening. She clarified that it has not went away she is still having a reaction. Her fever has gotten better went from 103 to 99. She took Tylenol and packed herself in ice. Around midnight she broke out in rash on left breast, abdomen and side. It started Thursday (20May2021). It has continued and is persisting. She has taken Benadryl every six hours and ice packs. She is a breast cancer survivor. She is going try to go to the doctor today because her rash is not going away. A visit to emergency room or physician office was not required. The outcome of the events chills was recovered on 20May2021, fever was recovering; rash was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
60 2021-06-01 rash First covid vaccine 21Dec2020 Had second shot 08Jan2021; Rash in groin / lower abdomen; This is a sp... Read more
First covid vaccine 21Dec2020 Had second shot 08Jan2021; Rash in groin / lower abdomen; This is a spontaneous report from a contactable physician. This Physician reported for a 60-year-old female patient in response to HCP letter sent in cross reference case. A 60 year old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EH0899, Exp. Date: 31Mar2021, NDC: 59267-1000-01), via intramuscular in left arm on 08Jan2021 at 10:29 at a dose of 0.3 ml as a single dose for COVID-19 immunization. The patient had no history of allergies to vaccines or injectables. The patient did not receive any recent vaccines for any other conditions prior to the event. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine. The patient's BMI was 26 to 99. The patient had no AE's prior vaccination. The patient's medical history and concomitant medication refer the case 2020512502. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL1284, Exp. Date: 30Apr2021, NDC: 59267-1000-01), via intramuscular in left arm on 21Dec2020 at 12:52 at a dose of 0.3 ml as a single dose for COVID-19 immunization. After the second dose of vaccination in less than six hours, the patient had no new areas of rash irruption but had new rash at groin, went to her R sternal border and under her breasts, worked its way up to lower abdomen over a few days. A week later occurred on a couple of places on my right chest, sacral area, and nape of neck. The rash was extremely pruritic, red, raised and took another shot prednisone taper and took Benadryl. The patient did not undergo laboratory test. No other symptoms were present. The patient was letting know this in case anyone else has had this issue, that the vaccine can cause a rash. The patient was not sure if this was a side effect or an allergy but if a yearly vaccine was needed, the patient did not think the patient should get the Pfizer vaccine. The patient did not hospitalized and admitted to an intensive care unit (ICU). The patient felt well and declined exam or further medication. No further action was required, and patient was explained that it was difficult to say what the rash was due to but this was not a contraindication to further COVID vaccines and rash may not be vaccine related. The predisposing factors were cestice history and multiple medications. Culture was not performed. The patient did not use any antipyretic. The patient had not experienced any anaphylactic reaction and just a rash 24hrs after both COVID vaccine doses. The patient had no multiorgan involvement, dermatological/mucosal, generalized urticaria (hives), generalized erythema, angioedema (not hereditary), generalized pruritus without skin rash, generalized prickle sensation, localized injection site urticaria, red and itchy eyes, gastrointestinal. Outcome of the event rash in groin / lower abdomen was recovered and other event was unknown. Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
60 2021-06-01 hives, itchy skin 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 blister, vaccination site 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 2021-06-02 hardening, rash with redness, itchy rash pt received pfizer at outside location. Reports day after receiving vaccine had rash for 5 days. R... Read more
pt received pfizer at outside location. Reports day after receiving vaccine had rash for 5 days. Rash: bright red indurated splotches. Located on buttocks, truck thighs, arm. Pruritic and tender. Resolved 5 days later, except for erythematous patch on left medial thigh.
60 2021-06-02 vaccination site pain, vaccination site 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 vaccination site pain Headache; pain; site pain; Dry cough; Sneezing; This is a spontaneous report (letter response) recei... Read more
Headache; pain; site pain; Dry cough; Sneezing; This is a spontaneous report (letter response) received from a contactable consumer. This 60-years-old female consumer reported. A 60-years-old female patient received second dose of BNT162B2 (BNT162B2, Pfizer-BioNTech COVID-19 Vaccine, Solution of injection, Lot Number: EN6208), via intramuscular, administered in left arm on 31Mar2021 at 11:30 (at the age of 60-year-old) as 2nddose, single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (Lot number: EN9899) on 23Dec2020 at 10:00 via intramuscular, administered in arm left for COVID-19 immunisation and tested positive for Covid (drug ineffective), symptoms similar to flu, Loss of taste, Loss of smell, Body ache, On 28Dec2020 she went to hospital to get neurocloral infusion. Medical history included, seasonal allergy and concomitant medications included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]); metoprolol (METOPROLOL); atorvastatin (ATORVASTATIN). On an unspecified date, the patient experienced headache, pain, site pain, dry cough, sneezing. The patient still had dry cough. The patient did not require medical intervention. The patient was visited the emergency department. The patient was not hospitalized. The patient was not admitted to an Intensive Care. There is no information about organ involvement. On 27Dec2020, the patient underwent lab tests and procedures which included covid-19: positive. Patient was treated with Advil also took Vit D, Vit C, Zinc Nuletomy for sneezing and dry cough. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The outcome of the event dry cough was not resolved and other events was unknown. No follow-up attempts are needed. No further information is expected.
60 2021-06-03 redness odd sensation in her mouth; difficulty swallowing; mouth full of saliva; Her face, neck and chest we... Read more
odd sensation in her mouth; difficulty swallowing; mouth full of saliva; Her face, neck and chest were all very red and flushed; Her face, neck and chest were all very red and flushed; This is a spontaneous report from a contactable consumer (patiemt). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration on 04Mar2021 13:00 (at the age of 60-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included shellfish allergy from 2011 and ongoing (patient had an Epi-pen prescription on her patient portal information but she has never filled or used that prescription), pneumonia in 2017 and 2018 (occurred 2 years in a row, probably around 2017 and 2018), bronchitis from 2016 (one year bronchitis without Pneumonia, may have been 2016), prediabetic (Onset date: Probably 2015), obesity (Onset Date: Probably 2000), compromised immune status, blood pressure and thyroid. Concomitant medications included lisinopril taken for blood pressure from 2016 and ongoing; atenolol taken for blood pressure from an unspecified start date and ongoing; amlodipine taken for blood pressure from an unspecified start date and ongoing; hydrochlorothiazide taken for blood pressure from an unspecified start date and ongoing; levothyroxine taken for thyroid from 2016 and ongoing. On 04Mar2021 about at 13:50 the patient experienced odd sensation in her mouth, difficulty swallowing, mouth full of saliva, and her face, neck and chest were all very red and flushed. The patient stated that it was a slight reaction. The patient reported that she received her first dose of Pfizer COVID-19 Vaccine on 04Mar2021. She waited the 30 minutes and then left. As she was driving home felt she felt an odd sensation in her mouth, had difficulty swallowing and her mouth filled with saliva; so she pulled over and she looked in the mirror she was all red, her face, neck and chest were very flushed. She just did some breathing and tried to relax. She called her doctor and waited to hear back from her but didn't yesterday. She tried to drink water and just relax; she did not feel like she had to go to the emergency room. Her doctor got back to her today and had a teleconference. The patient did not have other vaccinations within four weeks prior to the first administration. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
60 2021-06-03 rash with redness, rash papular, rash 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 2021-06-03 vaccination site redness, bruising, vaccination site swelling needle was put in and burned like hell and her head kind of exploded; arm was throbbing; pain rotate... Read more
needle was put in and burned like hell and her head kind of exploded; arm was throbbing; pain rotated out everywhere after 30 minutes; burn a little regarding; incapacitated; injection site swelled and turned red; injection site swelled and turned red; non-anaphylactic reaction; nightmare; Bruise; This is a spontaneous report from a contactable consumer (patient). A 60-year-old (age at vaccination) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 22Feb2021 (lot number: EN6198; expiration date: 30Jun2021) as 1st dose, single, dose 2 via an unspecified route of administration on 15Mar2021 (lot number: EN6204; expiration date: 30Jun2021) as 2nd dose, single for COVID-19 immunisation and varicella zoster vaccine rge (cho) (SHINGRIX), via an unspecified route of administration, administered in left deltoid on 01May2021 (lot number was 9NH54 and expiration date was 14Oct2022), at an unknown, single dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient family history included shingles (caller mother had shingles). On an unspecified date, the patient experienced needle was put in and burned like hell and her head kind of exploded, arm was throbbing, pain rotated out everywhere after 30 minutes, burn a little regarding, incapacitated, injection site swelled and turned red and non-anaphylactic reaction. The clinical course of the event was reported as: caller stated that her pharmacist told her to report because she had Shingrix vaccine injection on 01May2021 and had a non-anaphylactic reaction but her reaction was epic and her pharmacist said that the company would want to know this information for the numbers related to the product. It was reported that her weight was when she was fully dressed. The caller stated for Shingrix vaccine, the needle was put in and burned like hell and her head kind of exploded and that was epic. The nurse said it did burn a little regarding the patient stating Shingrix vaccine burned upon administration; stated the nurse let her go but she wanted to stay in the store for a few minutes and it felt really awkward; her head settled down and her arm was throbbing and started screaming; stated the pain began in her lower back and her arm, head and right side of her hip and moved throughout her body and the pain rotated out everywhere after 30 minutes the pain settled down and she just had the pain in her arm. She stated the area where Shingrix was injected was almost like a baseball sized circle and was read and she had to drive to care for her parents and that made this a nightmare. She removed the band aid from the injection site because the band aid caused a bruise and the injection site swelled and she remembers taking the band aid off and not being able to put ice on it and could not bear the pain. She could not put ice or clothes on top of the injection site and could not take it. She reported her head was just killing her and it was ridiculous to had to use that arm and to lift it like a disabled arm, she would say she was incapacitated and only if forced could she do something under those conditions. She stated the injection site swelled and turned red and just continued to swell, turn red and was burning and hurting and did not go farther and was the size of a baseball. She reported that the other symptom was she had her head back down and no pain in her back anymore, no pain in her chest anymore, and no pain in her legs anymore. She stated the pain after Shingrix vaccine was localized but gave her a headache; states using that arm was insane and if she was not forced to use the arm she could not use it effectively and this was not an anaphylactic reaction and the reaction was not moving anywhere else; stated the area of the injection site is now black all around it like the nurse gave a bad vaccine but she did not do a bad job; stated she could see the dot where the Shingrix vaccine went in. Stated the indication for which she had Shingrix vaccine was that her mother had shown up with shingles and they took her to the emergency room on Sunday (as reported) with a rash that began to bubble so the caller called for her mother; stated her mother was transported to the hospital and the caller had been wearing gloves and thought it was contagious and it was shingles; states the six doctors for her mother in the ER pressed the caller to get Shingrix vaccine. Caller stated the reported reaction for Shingrix vaccine lasted 11 days and sort of calmed down and all she could see now was the red dot where the vaccine was administered; stated she was sure she would have to do Shingrix again due to her reaction and did not have an anaphylactic reaction but wanted to report this as she was told. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
60 2021-06-03 vaccination site pain I was unresponsive, he could not wake me up; Had pain in my neck on the same site of the shot; Had p... Read more
I was unresponsive, he could not wake me up; Had pain in my neck on the same site of the shot; Had pain in my neck on the same site of the shot.; Nerve pain; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration, administered in left deltoid (left arm) on 17May2021 (at the age of 60-year-old, Batch/Lot Number: EW0177) as a single dose for Covid-19 immunization. Medical history included the patient had a child arrhythmia; she believed it was from 1996 but it pretty much controlled and prior to vaccine. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. This report was not related to a study or programme. The patient stated that she had a concern because she took the first COVID vaccine on the 17May2021 and she was due to get the second one on the 07Jun2021 however she had some concern today. The patient stated that she had some changed episode of reactions on 17May2021, she started having pain, after she took the first one, on the same day, she had pain in her neck on the same site of the shot and had some effect of pain, a nerve pain and it had devastated to the back of her neck where she had her thick neck and she had to use warm pack on the back of my neck. It would be about 4'O clock in the morning which would be on the 18May2021 her husband was observing her because he is a nurse and he could not wake her up, he tried everything possible to wake her up and he attempted to perform cardiopulmonary resuscitation (CPR) on her, so she was concerned about putting herself again such an event taken place. The patient went to the emergency room. They took her to the emergency room however she got her name administered in 'first a clinic' and he was able to stabilize her. The patient went to the emergency room and when she got there it was like a concerning so when she got there, she was not seen by the doctor because she was feeling little better but the context person, and they did concern that some of the episode she had, she saw the effect after COVID vaccine, she was concerned because she was due for the second vaccine and this was the first episode which she had, and she was concerned whether not should, she take the second shot, she went on her and she reported. The patient could not get this anyone, all she got was the worst. They took her to late but whatever she never got a chance to speak with anyone in her life, you know she do consult with her doctor has followed her so she was concerned now that she would have a second shot, she did not know if she could really take it. When concern confirmed the patient stated that she did have adverse reactions to the Covid-19 shot. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.
60 2021-06-04 vaccination site pain severe chills; severe soreness in shot area; lethargic; This is a spontaneous report from a contacta... Read more
severe chills; severe soreness in shot area; lethargic; This is a spontaneous report from a contactable other HCP. A 60-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810), via an unspecified route of administration, administered in Left Arm on 10Feb2021 as single dose for (at the age of 60-year-old) covid-19 immunization. Medical history included arrhythmia neonatal, thyroid disorder, gout and umbilical hernia. Other medical history reported as tachy-Brady syndrome, thyroid, gout, umbilical hernis. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination and post vaccination, patient had tested with covid 19. No known allergies reported for the patient. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); allopurinol (ALLOPURINOL); and digoxin (DIGITEK). These Other medications are administered in two weeks. On an unspecified date the patient experienced severe chills, severe soreness in shot area and lethargic. No treatment received for the event. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.
60 2021-06-06 rash with redness, injection site reaction, injection site pain 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 shingles Shingles outbreak on same side as vaccine administration. The last outbreak of shingles I had was ap... Read more
Shingles outbreak on same side as vaccine administration. The last outbreak of shingles I had was approximately 5 years ago.
60 2021-06-07 rash, shingles 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 2021-06-07 rash, itchy skin, blister 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 rash severe headache; major rash with prickle feeling on face, chest, both arms; major rash with prickle ... Read more
severe headache; major rash with prickle feeling on face, chest, both arms; major rash with prickle feeling on face, chest, both arms; lethargic; This is a spontaneous report from a contactable other-healthcare professional (patient) reported for herself. A 60-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6202, Expiration date: Unknown) via an unspecified route of administration, in the left arm on 03Mar2021 11:45 AM (at the age of 60-year-old) as 2 ND DOSE, SINGLE for COVID-19 immunisation at public health clinic. The patient medical history included tachy-Brady syndrome, thyroid, gout and umbilical hernis. The patient had no known allergies. The patient previously received her first shot of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN9810, Expiration date: Unknown) via an unspecified route of administration, in the left arm on 10Feb2021 (at the age of 60-year-old) as 1 ST DOSE, SINGLE for COVID-19 immunisation and had severe chills, severe soreness in shot area, lethargic. The patient received the medication within 2 weeks included Synthroid, Allupurinol and Digitex. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 03Mar2021 at around 15:00, the patient had experienced severe headache, major rash with prickle feeling on face, chest, both arms and lethargic. The patient did not received treatment for adverse events. The outcome of all events was resolving. No follow-up attempts are possible. No further information is expected.
60 2021-06-07 skin burning sensation, rash developed a "severe reaction"; body aches; constant rash; burning sensation on the back; fever; she ... Read more
developed a "severe reaction"; body aches; constant rash; burning sensation on the back; fever; she feels uncomfortable; has stomach issues; Tired; This is a spontaneous report from a contactable consumer or other non hcp. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number was not reported expiry date was not reported) dose 1 via an unspecified route of administration on 04Mar2021, as FIRST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient developed a severe reaction, with body aches, constant rash, burning sensation on the back, fever, she feels uncomfortable, tired, and has stomach issues. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
60 2021-06-08 shingles Major case of shingles; This is a spontaneous report from a contactable consumer (patient herself). ... Read more
Major case of shingles; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EP6955, NDC number: Unknown, Expiration date: Unknown), via an unspecified route of administration, administered in Left arm on 25Mar2021 at 07:30 (at the age of 60-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included covid-19, a year ago in March. The patient had no allergies to medications, food, or other products. Other conditions and Investigations were not provided. Concomitant medications included losartan (LOSARTAN) taken for an unspecified indication, levothyroxine sodium (SYNTHROID) taken for an unspecified indication on an unspecified date received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination in march a year ago. The patient has not been tested for COVID-19 since the vaccination. It was reported other vaccine same date details: 25Mar2021. It was reported that, the patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0167), via an unspecified route of administration, administered in Left arm on 13May2021 at 11:00 for covid-19 immunisation. On 10Apr2021 at 13:00, the patient had Major case of shingles/shingles two weeks after her first dose of the shot, which she reported to Pfizer already. Adverse event resulted in Emergency room/department or urgent care. Treatment for adverse event included Valtrex. The patient received 14 days of antiviral therapy after the first dose for shingles. She wanted to know if she can take the antiviral again prophylactically, so she does not have shingles again after her second dose yesterday (received after 50 days from the first dose). Caller stated that others have developed shingles after the vaccine so it would be a side effect. She said she has two doctors that said for her to wait to have her second shot, until her shingles symptoms cleared up, so she had her second shot yesterday. She said she had her second COVID shot at about 50 days out from her first dose. She said her question was that she was wondering because she was not sure if she might get another case of shingles from the second shot, if she should start an antiviral medication to prevent that, but she doesn't want to jeopardize the Pfizer COVID-19 vaccine. She says she has seen where a lot of different people, including four of her neighbors, got shingles after getting the Moderna or Pfizer COVID-19 shot. The reporter wanted to know if she can start an antiviral medication to prevent getting shingles again from the Pfizer COVID-19 vaccine and if antiviral would affect the efficacy of the Pfizer covid vaccine and interfere with the vaccine? She said her first dose LOT: EP6955. She said this dose was injected in her left arm. The reporter declines to complete reports on her neighbours who had shingles after their first doses and said she doesn't have their information to provide. She said she told them they should report it, she said she doesn't know their information, but her colleague also has two friends that got shingles as well. No further details reported, captured, or documented about her neighbors or her colleague's friends. Caller said that she has no new things to add to her previous report. The reporter assessed event as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused or prolonged hospitalization, Disabling or Incapacitating, Congenital anomaly or birth defect. The outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021551647 same reporter/drug/event, different patient
60 2021-06-08 shingles Approximately 5 days after the patient received her first dose of the Pfizer COVID vaccine, she deve... Read more
Approximately 5 days after the patient received her first dose of the Pfizer COVID vaccine, she developed shingles. She was properly treated and received her 2nd dose on 5/5/21
60 2021-06-08 rash, shingles, itchy skin I woke up one morning with a rash on my left torso. I called my doctor. The nurse practitioner diagn... Read more
I woke up one morning with a rash on my left torso. I called my doctor. The nurse practitioner diagnosed it as Shingles. I was prescribed an antiviral for seven days. I experienced some tiredness and achiness as well. There was itchiness from the rash that occurred but it gradually went away. Though the rash itself took 4 weeks to completely go away.
60 2021-06-08 vaccination site pain Slight headache; sore arm where vaccine was administered; This is a spontaneous report from a contac... Read more
Slight headache; sore arm where vaccine was administered; This is a spontaneous report from a contactable consumer (patient herself) reported that a 60-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in left arm on 10Mar2021 at 10:00 AM as a single dose for COVID-19 immunisation. The patients medical history included High blood pressure and has no allergies. Concomitant medications included Rosuvastatin 10mg, and Metoprolol Tartrate 50mg. 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. On 10Mar2021 at 10:00 AM, the patient experienced Slight headache and sore arm where vaccine was administered. No treatment was received for the adverse events. The patient was not diagnosed with Covid-19 prior vaccination and has not been tested for Covid-19 post vaccination. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
60 2021-06-08 vaccination site swelling, redness, itchy rash, skin swelling, vaccination site itchiness, vaccination site rash hurt more; rash itching; redness; Developing the short sight like a rash and it's you know kind of p... Read more
hurt more; rash itching; redness; Developing the short sight like a rash and it's you know kind of puffy and hot; Developing the short sight like a rash and it's you know kind of puffy and hot; at the injection site is itchy, rash and swollen; at the injection site is itchy, rash and swollen; at the injection site is itchy, rash and swollen; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female consumer (patient) reported that: A 60-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0177; Expiration date: Unknown), via unspecified route of administration injected in upper left arm on 27May2021 as single dose for covid-19 immunization. The patient medical history included immediate allergy to penicillin. The patient's historical vaccine included first does of bnt162b2 on 06May2021. Past drugs included penicillin and fexofenadine (ALLEGRA). The patient called to inquire that she had taken fexofenadine (ALLEGRA) in the past and whether she can put diphenhydramine (BENADRYL) on it. She was responded from the attached CONS. The patient stated that she had received the second dose of bnt162b2 on 27May2021. She stated that on an unspecified date in 2021, it hurt more, and she was experiencing rash and itching. She said, the week prior to that little bumps on legs which was last Tuesday and dose was given on Thursday. She was asking if this was a reported adverse event greater than Day One post vaccination. The patient was responded from attached and Full EUA Prescribing Information 6.1 Clinical Trials Experience LAB-1457-9.0 Revised: 19May2021. The patient stated that she had called three times and was given VAERs information. The AE was E-transmitted and she was referred to HCP. The report was not part of study or program. The patient stated that she had developed short sight like a rash and it was kind of puffy and hot on an unspecified date in 2021. The patient did not specify seriousness of the events itchy rash, puffy skin and feeling hot. The patient stated that she got her second shot last Thursday, which was on 27May2021 and she noticed some redness and stuff, but she didn't get sick at all after the next day or anything like that, but today she was developing the short sight like a rash and it was kind of puffy and hot. She did not know if that was normal. She inquired whether most people will get the reaction right away. She confirmed that it was Pfizer COVID-19 vaccine. When informed about the Pfizer medical information department for the concern, the patient stated that they gave her a number and said to press 3 already. She was informed that after dialing the number, she needs to press option 3 to reach the department. The patient stated that that's what she did and then they asked her for another option and then another option. So, she pressed option 3, then option 2 and then option 1. The patient was informed that in order to reach the Pfizer Medical Information Department she needs to press option 3 and if she pressed option 1 then she would reach Department. The patient stated that she did exactly the same and that's how she got connected to the Pfizer Department. She was informed the role of Pfizer drug Safety Department and asked for permission to probe questions, upon which the patient replied that she just wanted to talk to somebody who could tell her whether it was okay. She wanted to check if anybody has had it and said that she was actually at work and was trying to get to the Pfizer drug Safety Department before 8 o' clock. The patient was provided with timings of Pfizer medical information department as 8 AM to 8 PM on Monday to Friday and 9 AM to 3 PM on Saturday and Sunday, EST. The patient was unwilling to complete the report. Hence, limited information was available. The patient called again and stated that she experienced "injection site is itchy, rash and swollen" on an unspecified date in 2021. She was unsure about the lot number whether it was EW "O" 117 or EW "zero" 117. Expiry date of the covid-19 vaccine was unknown. The patient stated that she called because she had the second shot on last Thursday, and she did not know because she did not have any reaction to it, but today (on an unspecified date in 2021) "at the injection site is itchy, rash and swollen". She wanted to know whether it was normal. She confirmed that the shot was of Pfizer Covid 19 vaccine. She confirmed her second shot was on last Thursday, on 27May2021. She stated that the first shot was three weeks apart to that. She did not recall the exact date, but believed it to be Thursday. She stated it was 06May2021, which was 21 days apart. She was unsure of the lot number whether it was EW, zero or O, 177. The outcome of the events were unknown. Further probing was not done hence limited information available over the call.
60 2021-06-10 redness, rash, itchy rash Itching rash and redness started on right hand move to wrist top of hand then under right eye cheek ... Read more
Itching rash and redness started on right hand move to wrist top of hand then under right eye cheek then neck, chest , back then went to Dr. told me to use the cream she prescribed Triamcinolone using the rash has spread to some parts of both legs and breast still using medicine on legs and breast area
60 2021-06-10 vaccination site pain soreness at site of vaccine when lifting arm and some movements, tender to touch-mild; This is a spo... Read more
soreness at site of vaccine when lifting arm and some movements, tender to touch-mild; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955) via an unspecified route of administration administered in left arm on 13Mar2021 at 13:45 (at 60 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included allergic rhinitis and known allergies: peanuts and penicillin. The patient previously took vancomycin and experienced allergies. Concomitant medications included fluoxetine, fluticasone propionate (FLONASE), calcium, vitamin B complex (B COMPLEX), and colecalciferol (VIT D3); all from unspecified date for unspecified indication. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced only soreness at site of vaccine when lifting arm and some movements, tender to touch-mild; non-serious on 13Mar2021. No treatment received for the events. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
60 2021-06-10 vaccination site pain This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pr... Read more
This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via an unspecified route of administration in the left arm on 17Mar2021 at 12:00 pm (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (BP) and oyster allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via an unspecified route of administration in the left arm on 24Feb2021 at 11:00 am as a single dose for COVID-19 immunisation. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. On 18Mar2021, patient experienced soreness at injection site, headache and chills. No therapeutic measures were received for any event. The clinical outcome of the events soreness at injection site, headache and chills was resolved on 18Mar2021. No follow-up attempts are needed. No further information is expected.
60 2021-06-12 injection site pain Pain in my left arm and shoulder. I cannot raise my arm above my head. I have sharp pain in my arm... Read more
Pain in my left arm and shoulder. I cannot raise my arm above my head. I have sharp pain in my arm, I cannot put any weight on that arm. I went to a shoulder specialist who prescribed Physical Therapy.
60 2021-06-12 injection site pain 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 2021-06-12 rash vesicular patient received Pfizer covid vaccine on 5/12/21. pt called and spoke to rph about having chest pain... Read more
patient received Pfizer covid vaccine on 5/12/21. pt called and spoke to rph about having chest pain and SOB. she was advised to seek medical help. pt went to urgent care according to pt she had an abnormal EKG and was referred to her pcp and cardiologist. In addition to the chest pain and SOB, she also reported having a blistering rash on her back She finally able to see her pcp and her cardiologist. Per pt, EKG is back to normal . She is only complaining about the blister scabs on her back
60 2021-06-13 redness, rash papular, rash, itchy skin, injection site rash The next day when I woke up after receiving the vaccine, I was feeling very itchy everywhere. I had ... Read more
The next day when I woke up after receiving the vaccine, I was feeling very itchy everywhere. I had rash around the injection site and my extremities (both ankles, back, left arm). I did not take any medications. The rash went away very quickly within 8 hours but I was still feeling very itchy and wanting to scratch constantly. After 2 days, I decided to go to the doctor. I was prescribed 1 week of oral steroids (Prednisone 20mg) and hydroxyzine 25mg. The redness went away, but I could still feel the raised bumps. After 4 days of steroids, I started to feel much better and the itchiness went away.
60 2021-06-13 rash I broke out with a rash all over my body along with a 101 temperature for the week. The Nurse Practi... Read more
I broke out with a rash all over my body along with a 101 temperature for the week. The Nurse Practitioner thought that it may have been COVID and it went on for three weeks. I ended up with the symptoms but not the virus so they worked to get me back to normal.
60 2021-06-15 redness 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 2021-06-15 rash patient seen in ER for rash on left arm, chest, neck and left leg
60 2021-06-16 rash with redness Almost immediate bright red rash all over hands - front and palms. looked like hands dipped in red p... Read more
Almost immediate bright red rash all over hands - front and palms. looked like hands dipped in red paint.; This is spontaneous report from 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: LOT #EN6207) via an unspecified route of administration in the left arm on 18Mar2021 at 14:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included was not reported. concomitant medications includes herbal supplement. The Patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient experienced immediate bright red rash all over hands from front and palms. Looked like hands dipped in red paint on 18Mar2021 at 14:30. Adverse event result in Doctor or other healthcare professional office/clinic visit and no treatment was received for the event. The clinical outcome of the red rash was recovering. No follow-up attempts are needed. No further information is expected
60 2021-06-16 rash 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 vaccination site itchiness, vaccination site pain On my right arm here got the second shot, I noticed there is a scar; I was keep scratching my arm an... Read more
On my right arm here got the second shot, I noticed there is a scar; I was keep scratching my arm and that was where I got the vaccine shot then it irritate; On my right arm here got the second shot, I noticed there is a scar; I was keep scratching my arm and that was where I got the vaccine shot then it irritate/ then feels itchiness and scratching; On my right arm here got the second shot, I noticed there is a scar; I was keep scratching my arm and that was where I got the vaccine shot then it irritate; Yes, my arm is sore/ then I noticed it's going to sore on their/ Outcome of event: Consumer stated, "It's getting worsened because it's scratching in arm, it's getting sore."; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0165 and expiration date: 31Aug2021), second dose via an unspecified route of administration, administered in right arm on 25May2021 at 08:30 (at the age of 60-yeasr-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing, no investigation assessment was reported. Concomitant medications included adalimumab (HUMIRA); gabapentin (GABAPENTIN); celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported. Historical vaccine given to patient previously was dose 1 received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EW0165 and expiration date: 31Aug2021), via an unspecified route of administration, administered in left arm on 04May2021 at 08:30, as a single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. It was reported that, on 25May2021, her right arm here got the second shot. The patient stated the first one was fine, and this was her second one. she put the bandage on it and then she thought it was okay and then took it off and then feels itchiness and scratching and look at and noticed there was a scar on it. The patient noticed there was a scar for the second time and for first time when she saw it, it was like five days after, and she was keep scratching her arm and that was where she got the vaccine shot then it irritates then no then she felt it again and then she noticed it's going to score on their and she wondered she want to know what she should supposed to do. The patient stated it was getting worsened because she was scratching in arm and it was getting sore. The patient just wants to know, what can she do with her arm. Should she go to the hospital or should she do anything. Treatment of the event, consumer stated no she did not want to take. The outcome of the events was unknown. Information on batch/Lot number was obtained. Further information has been requested.
60 2021-06-17 redness lost sense of taste; felt really tired; Her whole face and neck was really red and felt like it was ... Read more
lost sense of taste; felt really tired; Her whole face and neck was really red and felt like it was on fire; trouble breathing; face felt like it was on fire; headache; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0168), via an unspecified route of administration, administered in left arm on 19May2021 09:00 (age at vaccination: 60 years) as 1st dose, single dose for covid-19 immunisation. The patient's medical history included ongoing multiple allergies. She has had allergies her whole life. Concomitant medication included rosuvastatin calcium (CRESTOR OD) taken for blood cholesterol increased which she has taken it for 15 or 20 years; fenofibrate (LIPOFEN) taken for blood cholesterol increased, which probably she has taken it for 15. On 19May2021, she experienced multiple symptoms 15 minutes after initial vaccination including, trouble breathing which started maybe an hour after she had the vaccine, face felt like it was on fire which lasted for 2 or 3 days, headache, felt really tired and her whole face and neck was really red and felt like it was on fire; on 21May2021, the patient lost sense of taste. Her sense of taste is back now. She thinks her tiredness has gone away. The adverse events did not require emergency room visit or a physician's office visit. The patient did not get other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient feels hesitant about getting her second dose of the vaccine tomorrow and would like some guidance, asking if she should get her second dose or not. The outcome of the event dyspnoea was reported as not recovered; burning sensation, erythema was unknown; headache was recovered on 24May2021, Ageusia was recovered on 23May2021 and tiredness was recovered on May2021. Information on Lot/Batch number was available. Additional information has been requested.
60 2021-06-17 rash Severe aches and pain; chills; Fatigue; Full body rash; first dose on 04Mar2021 at 08:00 AM/second d... Read more
Severe aches and pain; chills; Fatigue; Full body rash; first dose on 04Mar2021 at 08:00 AM/second dose on 17Mar2021 at 08:30 AM; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Not known) as a single dose via unspecified route in right arm on 17Mar2021 at 08:30 AM (at the age of 60-year-old) for COVID-19 immunisation. The patient medical history included known allergies to penicillin and non-steroidal anti-Inflammatory drugs (NSAIDS). Patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Not known) as a single dose via unspecified route on 04Mar2021 at 08:00 AM (at the age of 60-year-old) for COVID-19 immunisation of event rash, swollen lips, tingle lips. Concomitant medications included biotin and multi vitamin (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021 at 17:00, the patient experienced severe aches and pain, chills, fatigue and full body rash. The treatment was taking Benadryl and Tylenol received for the events. The clinical outcome of severe aches and pain, chills, fatigue and full body rash was not recovered at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
60 2021-06-17 rash patient started developing a rash 4 days after vaccine. Rashes are located in different locations su... Read more
patient started developing a rash 4 days after vaccine. Rashes are located in different locations such as wrist, forearm, underarm, each leg near knne, one on chest. Patient does not report any SOB or issues breathing.
60 2021-06-21 shingles, rash macular On the morning of April 8, 2021, dull, achy lower back pain woke me up and did not subside throughou... Read more
On the morning of April 8, 2021, dull, achy lower back pain woke me up and did not subside throughout the day. The next morning, April 9, 2021 (2 weeks to the day of my 2nd Pfizer vaccine dose), I noticed a few spots on my lower left to middle torso. The pain was increasingly unbearable. I immediately suspected possible shingles and went to ER where I was diagnosed with shingles. I was prescribed a 10 day dose of antiviral acyclovir along with Percocet. As of this date, despite various OTC remedies as well as completing all medications prescribed, I still have inflammation, pain that intensifies throughout the day, as well as periodic numbness, primarily on my left side (which was the site of the original shingles attack).
60 2021-06-24 shingles I got shingles. I got the shingles shot that should have prevented me from getting the shingles. I w... Read more
I got shingles. I got the shingles shot that should have prevented me from getting the shingles. I went to the doctor and was diagnosed with it.
60 2021-06-24 itchy skin her voice feels a little weak; having problems breathing; lot of Phlegm; coughing a lot; fingers sta... Read more
her voice feels a little weak; having problems breathing; lot of Phlegm; coughing a lot; fingers started tingling; waves of nausea; light headedness; She started to itch; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN8203 and expiration date 30Aug2021), via an unspecified route of administration in left arm on 01Mar2021 at 14:30 (age at vaccination 60-year-old) as single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus, hashimoto's disease, high cholesterol and high blood pressure. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. On 01Mar2021, with a few minutes just driving to the waiting spot she was having problems breathing. There was plenty of staff there in the hospital parking lot to help. They were monitoring her oxygen and her heart also on 01Mar20210, patient experienced lot of phlegm, coughing a lot, fingers started tingling, waves of nausea, light headedness and on 03Mar2021, patients voice felt a little weak. She was treated with Benadryl and an inhaler. The outcome of event having problems breathing, fingers started tingling, light headedness, waves of nausea was recovered on 01Mar2021. The outcome of event lot of Phlegm and coughing a lot was recovering at the time of reporting. The outcome of itching and her voice feels a little weak was unknown. No follow-up attempts are possible. No further information is expected.
60 2021-06-27 itchy skin, skin warm 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 injection site pain 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 redness, itchy skin 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 hives, rash papular, itchy skin Area on back of right thigh, two places on right ankle - raised rash with hive-like symptoms. Very ... Read more
Area on back of right thigh, two places on right ankle - raised rash with hive-like symptoms. Very itchy.; Area on back of right thigh, two placeson right ankle - raised rash with hivelikesymptoms. Very itchy.; Area on back of right thigh, two placeson right ankle - raised rash with hivelikesymptoms. Very itchy.; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration on the right arm on 11Mar2021 at 00:00 hours (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patients medical history was not reported. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and estrogen (MANUFACTURER UNKNOWN) all for unknown indication. The patient had allergies to codeine, sulfa and naproxin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. On 15Mar2021 at 12:00 hours, the patient experienced area on the back of the right thigh, two places on the right ankle had raised rash with hive-like symptoms and were very itchy. No therapeutic measures were taken for the events. The clinical outcome of the events raised rash, urticarial symptoms and itchy was not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
60 2021-06-29 vaccination site redness, vaccination site itchiness Large, red, itchy spot around injection site; Large, red, itchy spot around injection site; This is ... Read more
Large, red, itchy spot around injection site; Large, red, itchy spot around injection site; 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: EN6207), via an unspecified route of administration in the left arm on 12Mar2021 at 12:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as stage 3B kidney disease/ pacemaker. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included diltiazem (MANUFACTURER UNKNOWN), baby aspirin (MANUFACTURER UNKNOWN), multi-vitamin (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN), all taken for unknown indication and from an unknown date. On 18Mar2021, the patient experienced large, red, itchy spot around injection site that appeared about 1 week after vaccination. No therapeutic measures were taken as a result of the adverse events. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event large, red, itchy spot around injection site was not resolved at the time of this report. No follow up attempts are needed. No further information is expected.
60 2021-06-29 vaccination site pain, vaccination site itchiness, vaccination site redness, vaccination site mass Sore at the injection site; Itchy at and around the injection site; Red at the injection site; Sligh... Read more
Sore at the injection site; Itchy at and around the injection site; Red at the injection site; Slight lump at the injection site; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the right arm on 11Mar2021 at 18:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was unsure if the patient had any allergies to food, medications, or other products. The patient did not receive any medication within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021 at 16:00, after one week of vaccination, the patient experienced redness, soreness, slight lump and also itchy at and around the vaccination site. The adverse events result in a visit to the doctors or other healthcare professional office/clinic visit. The patient was treated with antihistamines for the reported events. The clinical outcome of the events redness, soreness, slight lump and, itchy at and around the vaccination site was not recovered. No follow-up attempts are needed. No further information is expected.
60 2021-06-30 shingles Patient stated that 2 weeks after receiving 2nd dose of Pfizer vaccine, she developed Shingles. Pati... Read more
Patient stated that 2 weeks after receiving 2nd dose of Pfizer vaccine, she developed Shingles. Patient stated that she saw her doctor to be treated for shingles. Patient was prescribed anti-viral medicine and Gabapintin. Patient states that she still has shingles.
60 2021-06-30 injection site reaction Pfizer-BioNTech COVID-19 Vaccine EUA: After receiving dose 1 on 5/19/21 & 2nd dose on 6/9/21, I noti... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: After receiving dose 1 on 5/19/21 & 2nd dose on 6/9/21, I noticed daily, low-grade headache and continued muscle soreness in my left arm at the injection site that was used for both vaccines. I had frequent flushing/burning in my cheeks. As of 7/1/21, these symptoms linger but are becoming lesser. I treat the headache as needed with OTC ibuprofen. Note: When I contracted & was treated for Lyme's disease in or @ 2010, I had severe daily headaches for 1 year & then they went away. The covid vaccine side effects seem to be similar to the Lyme disease side effects.
60 2021-06-30 itchy skin On Sunday night, my hands became very itchy; overnight my entire body became itchy; This is a sponta... Read more
On Sunday night, my hands became very itchy; overnight my entire body became itchy; 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 unspecified route of administration on right arm on 20Mar2021 (at the age of 60-year-old) at 11:15 AM as a single dose for COVID-19 immunisation. Medical history included asthma and Chronic obstructive pulmonary disease (COPD). The patient reported no known allergies to medications, food, or other products Concomitant medications included spiriva (MANUFACTURER UNKNOWN), SYMBICORT, montelukast (MANUFACTURER UNKNOWN), FLONASE and prednisone (MANUFACTURER UNKNOWN) for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID post vaccination. On 21Mar2021 at 08:30 PM patient experienced generalised itching. It was reported that on Sunday night, the patients hands had become very itchy; overnight her entire body became itchy but she did not develop a rash or hives and her breathing was fine. Although it was Tuesday and she still had itchiness. Therapeutic measures were taken as a result of event and included self-treatment with benadryl. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event generalised itching was not recovered. Information about lot/batch number has been requested.
60 2021-06-30 rash, shingles I went into the hospital with chest pains on the left side of my body (developed a rash that wrapped... Read more
I went into the hospital with chest pains on the left side of my body (developed a rash that wrapped around on side of my body and I went to the ER where the Doctor saw red marks all over my body (developed shingles a month after taking the vaccine) and was placed on antivirals for 7-days days by the PA in my doctor's office. I have never had Shingles before. The pain was very severe and it didn't go away until a month later. I was referred to a Cardiologist to perform a stress test to ensure my heart was ok.
60 2021-07-01 injection site pain, injection site hardening, injection site mass, itchy skin Itching on the arm (started within the first hour) and sore and my arm felt heavy (injection site a... Read more
Itching on the arm (started within the first hour) and sore and my arm felt heavy (injection site arm). Hard to lift my arm. I noticed my fingers were swelled up. The itching never has gone away. I still get it. The swollen fingers took about two weeks to go away. I hadn't been able to take my wedding rings off. Heaviness didn't go away. When I got the second shot that got worse (heaviness). March 28 was date of second Pfizer vaccine - LOT# ER8730. The itching felt more prominent and I couldn't scratch by that time so I would try to rub it lightly to calm it. I would put warm compresses on my arm jus to fall asleep. I went to the doctor - I had to see a resident doctor in the office - that might have been 6/2/2021. He prescribed me to take two Aleve's morning and night. And he prescribed a muscle relaxant and Naproxen but none of that worked. I can't extend my arm unless I use my other arm to do it. It wakes me up at night. They also prescribed physical therapist and I had my second Physical therapy appt yesterday but it just hurts - they have scheduled me for12 sessions. I had realized there was a lump on the arm on the first week of May. Now the lump is bigger and you can feel hardness inside. Doctor could see it. The lump is a little lower to the right of the injection site. If I put my three middle fingers together it kind of covers the size - so it's the width of three finger. And that hurts - it wakes me up at night even if I'm not sleeping on it. I'm usually pretty tolerant of pain and I don't usually have time to go to the doctor but this is how bad it hurts - I had to go to the doctor. My physical therapist says they have had patients come in with those same symptoms after their vaccines. I also get lightning bolt pain on the left side of top of my hand - on my left hand. It feels like a neurological issue.
60 2021-07-01 rash macular, itchy rash, bruising Urticarial vasculitis; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raise... Read more
Urticarial vasculitis; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raised bullseyes blotches with bruises in the middle; This is a spontaneous report received from a contactable nurse (patient). A 60-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: el1284 expiration date: unknown), via an unspecified route of administration in left arm on 06Jan2021 at 10:00 AM (at the age of 60 years old), as single dose for covid-19 immunization. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing. The patient had known allergies to sulfa and Wellbutrin. Concomitant medications the patient received within 2 weeks of vaccination included famotidine; and vitamin d for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EK5730 expiration date: unknown), via an unspecified route of administration in right arm on 16Dec2020 at 10:00 AM (at the age of 60 years old) for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced urticarial vasculitis developed symptoms On 06May2021, with pruritic raised bullseyes blotches with bruises in the middle. Treated with unspecified iv steroid, antihistamines and continued steroids and taper to colchicine. The adverse event result in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient was hospitalized for one day. The outcome of events of Urticarial vasculitis, Pruritic raised bullseyes blotches with bruises in the middle was recovering. Reporter considered events as serious. Information on Lot/Batch number was available. Additional information has been requested. ; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
60 2021-07-01 rash Possible anaphylactic shock, acute kidney injury, shock liver, hypotension, rash, thrombocytopenia. ... Read more
Possible anaphylactic shock, acute kidney injury, shock liver, hypotension, rash, thrombocytopenia. Full body rash, abdominal pain, vomiting, diarrhea, RLE pain, fever, dizziness, body aches, headache. Sx onset 06/26/2021 after receiving COVID vaccine #2 the same day. Pt went to medical facility on 06/30/2021 and was sent to ED. Pt admitted to ICU 06/30 - 07/02. Transferred to general medical floor on 07/02/2021.
60 2021-07-01 skin discolouration Bottom of both feet were very blue/purple, bottom of my feet became very red and eventually returned... Read more
Bottom of both feet were very blue/purple, bottom of my feet became very red and eventually returned to the normal color; Numbness in my hands and feet; Became very cold; 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: ER2613) via an unspecified route of administration in left arm on 23Mar2021 (at the age of 60 years) at 11:00 as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication included CRESTOR for an unknown indication. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination the patient had not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 23Mar2021 at 19:00, the patient became very cold whereas the temperature remained 97.3 (unspecified units) and bottom of the feet turned blue/purple. The patient took a warm bath after which the bottom of the feet became red and eventually turned normal. The hands and feet had numbness. No treatment was received for the adverse events. The clinical outcome for the events feeling cold, feet turned blue/purple and numbness of hands and feet were recovering. No follow-up attempts are possible. No further information is expected.
60 2021-07-01 skin discolouration Neck started turning black, tingling in breast and nipples
60 2021-07-01 vaccination site pain I am so confused; There is a sore there where I got it; I got a burning sensation in my whole body, ... Read more
I am so confused; There is a sore there where I got it; I got a burning sensation in my whole body, like a hot flash almost.; I got a burning sensation in my whole body, like a hot flash almost.; I am not taking the second shot; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, in Left Arm on 28May2021 (at the age of 60-years-old), as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history included Fibromyalgia syndrome; Diabetes; Conversion disorder; Arthritis; and consumer stated, "I have a Pacemaker. The patient's concomitant medications included insulin aspart (NOVOLOG) taken for diabetes mellitus; gabapentin (GABAPENTIN) taken for neuropathy peripheral; tizanidine (TIZANIDINE) taken for muscle relaxant therapy; meloxicam (MELOXICAM) taken for inflammation; and Klonopin. Consumer stated, no prior vaccinations within 4 weeks of prior vaccination. On an unspecified date, the patient reported that she was so confused, there is a sore there where she got it, she got a burning sensation in her whole body, like a hot flash almost, and she supposed to get the second shot on 07June2021but she was not taking it. She further stated that she had a bad reaction to the Pfizer shot. They had to put her in a nursing home. On an unspecified date, the patient underwent lab tests and procedures which included blood test: unknown, and sars-cov-2 test: unknown. The outcome for all the events was unknown. Information about batch/Lot number has been requested.
60 2021-07-02 injection site pain, rash, hives Left-arm shot area very sore first 24 hours. Slight headache. Left work nauseous feeling day after... Read more
Left-arm shot area very sore first 24 hours. Slight headache. Left work nauseous feeling day after. Slept very heavily 2nd night 2nd day woke up with hives on my left arm as the day progressed had a rash on my chest, stomach, back, and arms causing my anxiety to spike. Went to urgent care. Informed that I have hives,/rash, anxiety and that it had been day 2 of vaccine from pharmacy on Thursday
60 2021-07-04 shingles, rash Shingles, pain then rash (never had before)
60 2021-07-05 rash, pityriasis rosea (viral rash) Developed skin rash on back which progressed to armpits and groin area
60 2021-07-05 skin abrasion, injection site pain fever, sore arm at site, flu-like symptoms for 32 hours following the vaccine Today (7/6/21) I have... Read more
fever, sore arm at site, flu-like symptoms for 32 hours following the vaccine Today (7/6/21) I have dry mouth, dry eyes, sores on torso, tender thyroid, cracking skin, constant metallic taste in mouth, food tastes awful and irritates my mouth. Water helps to calm but symptoms never go away.
60 2021-07-06 injection site warmth, injection site redness, injection site pain, injection site swelling Worst part so far is inability to sleep, feels like heart racing since at least 07/06/2021 around n... Read more
Worst part so far is inability to sleep, feels like heart racing since at least 07/06/2021 around noon or 1:00; many many feelings like heart flip flops during same period - these things are continuing. injection site still hot, red and swollen and painful. Had fever 100.4 to 101.6 for twelve hours, head and body aches, joint pain - the fever and aches and pain started subsiding today. - the fever, aches and pains I understand are fairly common. Really had not expected the feeling that my heart is racing and flip flopping or the inability to sleep - may have got two hours last night - so that is why I am reporting. Not planning to seek medical care unless it continues another night or two.
60 2021-07-06 itchy skin The day after my second dose of the covid19 vaccine, I developed itchiness all over my body. It itch... Read more
The day after my second dose of the covid19 vaccine, I developed itchiness all over my body. It itches everywhere, every day, all the time. Feels like I have ants crawling on me all the time, it is so intense it sometimes wakes me up at night. There is no rash, no welts, no redness, just intense itching that moves around my body. Chest, back, thighs, legs, feet, arms, shoulders, scalp, face. antihistamines have no effect (Benadryl, Zyrtech, diphenhydramine), OTC itch cream and Calamine lotion do not work. Cool showers work briefly. I have never before experienced anything like this.
60 2021-07-07 injection site warmth, injection site swelling, injection site reaction, injection site pain, injection site redness, rash macular I got my first dose of the vaccine on the advice of my Rheumatologist. I have not been able to see h... Read more
I got my first dose of the vaccine on the advice of my Rheumatologist. I have not been able to see him yet. Two days after the first dose my left arm was really bothering me. My arm was red below the injection site and it was hot, raised up and painful. I couldn?t sleep on that side. I was very tired that week. I used antibiotic ointment and alcohol pads with a cold washcloth. I went back to the pharmacy. It looks better now after eight days. It is a little splotchy now, but the pain has gone down. I have also had more joint pain since I got the vaccine but that may be because I have not had any Embrel for two weeks. It feels like my Rheumatoid Arthritis is flared up.
60 2021-07-08 itchy skin Itching, bloody nose, palpitations, headaches for the week following, one severe, nausea
60 2021-07-08 hives, itchy skin, injection site hives 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 2021-07-10 redness, rash Lupus-like butterfly rash appeared pinkish 6 day after the first shot. A black spot appeared on nos... Read more
Lupus-like butterfly rash appeared pinkish 6 day after the first shot. A black spot appeared on nose side of nose two weeks after first shot and both sides of chin began to turn pinkish/red. Six weeks later, received second shot. One week after the second shot, the black spot on the nose slowly began to spread (noticeable every other day). Two weeks after second shot, pinkish butterfly rash (both cheeks and across nose) as well as both sides of chin began to get darker and spread.
60 2021-07-10 rash 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 2021-07-10 rash Migraine within 5 minutes, rash on chest & both upper arms
60 2021-07-11 rash with redness, rash, redness, injection site pain, injection site swelling 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 vaccination site pain, hives 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 2021-07-15 hives Monthly facial hives - have suddenly appeared for no reason every month for the last 3 months - no n... Read more
Monthly facial hives - have suddenly appeared for no reason every month for the last 3 months - no new products had been introduced - same hygiene routine and food. Disappear after a week or so.
60 2021-07-17 redness, vaccination site redness 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 2021-07-17 shingles Shingles; This is a spontaneous report from a contactable consumer (Patient). A 60-years-old non pre... Read more
Shingles; This is a spontaneous report from a contactable consumer (Patient). A 60-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 (age at the time 60-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: FN6205) via an unspecified route of administration in the left arm on 09Mar2021 (age at the time 60-year-old) as dose 1, single for covid-19 immunisation. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. List of any other medications the patient received within 2 weeks of vaccination reported as some. On 14Apr2021, the patient experienced shingles. The patient visited the doctor or other healthcare professional office/clinic visit for the adverse event. Therapeutic measures were taken as a result of shingles. The outcome of the event was not recovered. Follow-up (30Jun2021): Follow-up attempts are completed. No further information is expected.
60 2021-07-17 itchy skin bad allergic reactions; itchy on my hand, fingers and feet; This is a spontaneous report from a cont... Read more
bad allergic reactions; itchy on my hand, fingers and feet; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old non pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, administered in Arm Left on 14Feb2021 09:45 as DOSE 1, SINGLE for COVID-19 immunization. Patient is allergic to Solumedrol, Methylprednisolone and Penicillin. Patient took shots of methyprednisolone and Solumedrol shot, 2 weeks before the Pfizer vaccine shot. The 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. Patient had a bad allergic reaction off the methyprednisolone and Solumedrol shot. Possibly patient still had it still in the system. Patient had had itchy on the hand, fingers and feet from the Pfizer vaccine shot on 14Feb2021. Adverse event resulted in emergency room/department or urgent care and received treatment with Benadryl for the adverse event. Event recovered on an unspecified date. Since the vaccination, patient underwent sars-cov-2 test/nasal swab: negative on unspecified date. Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected.
60 2021-07-17 rash with redness Day 3 woke up with dizziness; Vertigo; Feel soreness in arm almost right after shot. Moved arm and m... Read more
Day 3 woke up with dizziness; Vertigo; Feel soreness in arm almost right after shot. Moved arm and massaged.; Developed a red rash at site for next 12 hours.; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 25Mar2021, (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient was allergic to amoxicillin and erythromycin. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021, at 07:00, the patient felt soreness in arm almost right after shot, moved arm and massaged and also developed a red rash at site for next 12 hours. Developed a red rash at site for next 12 hours. On 27Mar2021, the patient woke up with dizziness and vertigo. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events soreness in arm, vertigo and dizziness was not resolved, while the clinical outcome of red rash was resolved. No follow-up attempts possible. No further information expected.
60 2021-07-17 rash, vaccination site itchiness, blister, shingles Painful blisters and rash on left side, starting as small boils, diagnosed as Shingles, after second... Read more
Painful blisters and rash on left side, starting as small boils, diagnosed as Shingles, after second vaccine.; Painful blisters and rash on left side, starting as small boils, diagnosed as Shingles, after second vaccine.; Painful blisters and rash on left side, starting as small boils, diagnosed as Shingles, after second vaccine.; Sore, reclarified as left arm after the first and second vaccine; Fever, after the second vaccine; Muscle pain, after the second vaccine; Itching, left arm at the injection site, after second vaccine; Left side of body aching, after the second vaccine; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8735, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 03May2021 17:00 (at the age of 60-years-old) as dose 2, single for covid-19 immunisation in pharmacy. No vaccines administered on same date of the Pfizer suspect. The patient did not have prior vaccinations within 4 weeks. The patient did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Medical history included glucose tolerance impaired from 2020 and ongoing (patient stated probably last year), blood cholesterol increased from 2020 and ongoing (patient states at about the same time as diagnosed with prediabetes). Family medical history was none. Concomitant medication(s) included naproxen taken for arthralgia from an unspecified start date to 10May2021; valaciclovir hydrochloride taken for herpes zoster from 12May2021 and ongoing. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8729, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 11Apr2021 17:45 (at the age of 60-years-old) as dose 1, single for covid-19 immunisation in pharmacy and experienced she fell in the office and she had knee pain, Sore, reclarified as left arm after the first and second vaccine. On May2021, the patient experienced, muscle pain, after the second vaccine, itching, left arm at the injection site, after second vaccine, left side of body aching, after the second vaccine. On 04May2021, the patient experienced sore, reclarified as left arm after the first and second vaccine, fever, after the second vaccine. On 10May2021, the patient experienced painful blisters and rash on left side, starting as small boils, diagnosed as shingles, after second vaccine. The events resulted in physician office visit. Patient stated she was not sure if she had to call, but she still was in pain, and she wants Pfizer to know, so she can help other people. Patient stated she had her second dose of the vaccine and then the following day she was sore in morning. Patient stated she had a fever for 3 consecutive nights. Patient stated because she had normal effects, the vaccine was probably working. Patient stated on the third night she had muscle pain. Patient stated her left side of her body was aching and she used a pad on it for the muscle pain. Patient stated on 09May2021 or 10May2021, she had blisters that were painful on her left side. Patient stated that the blisters were diagnosed as Shingles. Reclarified, patient stated she had a video visit with her primary care doctor. Patient stated that and she noticed the rashes and blisters on the left side of her body. Patient stated they started as small boils and then blistered. Muscle pain started probably on morning of 05May2021 or 06May2021. Itching, left arm at the injection site, after second vaccine started on 05May2021 or 06May2021 and confirmed the itching is not like it first started. Left side of body aching, after the second vaccine started on noon of 05May2021 or 06May2021. Patient stated when she went to the urgent care for her knee pain, they gave her Naproxen Patient stated she stopped taking it when the rash and blisters appeared. Patient was thinking she was allergic to the medications, not the shingles. Patient stated she has high cholesterol and diabetic medications that she doesn't take. Patient stated she checks her blood sugar, and they are normal. Therapeutic measures were taken as a result of muscle pain, after the second vaccine with a pad on it and Motrin. Patient stated that when she takes Motrin it helps with the pain, but then it comes back when the medication wears off. The outcome of the event sore, reclarified as left arm after the first and second vaccine was recovered on an unspecified date of May2021. The outcome of the event fever, after the second vaccine was unknown. The outcome of the events muscle pain, after the second vaccine and itching, left arm at the injection site, after second vaccine was recovering and not recovered for other events. Information about Lot/Batch number is available. Further information has been requested.
60 2021-07-17 hives, vaccination site pain pain in injection side; cherry angioma; fatigue; muscle weakness; chills; fever; diarrhea; skin rash... Read more
pain in injection side; cherry angioma; fatigue; muscle weakness; chills; fever; diarrhea; skin rash (urticaria); on day five start of abdominal pain; 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 no: EN6205) via an unspecified route of administration in the right arm on 13Mar2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included cholinergic urticaria, lactose and fructose intolerance. The patient's allergic history included rhinitis, animal fur, mites, dust, NSAIDS (Nonsteroidal Anti-Inflammatory Drugs) causes urticaria. 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 vaccination, the patient was not diagnosed with COVID-19. On 18Mar2021, the patient experienced abdominal pain. On 20Mar2021 at 10:00, the patient experienced pain in injection side, fatigue and muscle weakness, chills, fever, diarrhoea, skin rash (urticaria), cherry angioma. Since the vaccination, the patient had been tested negative for COVID-19 on 21Mar2021. As a corrective measure the patient received cetirizine for all the events. The clinical outcomes of the events, pain in injection side, fatigue and muscle weakness, abdominal pain, chills, fever, diarrhoea, skin rash (urticaria), cherry angioma were recovering. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Patient's Postal Code added, Verbatim was updated for medical history. Relevant Med History Rhinitis was deleted as it is the reaction of animal fur, mites, dust allergy, Lab data "Rapid Diagnostic RNA test" deleted as it can be combined with PCR (Nasal Swab), Vaccine Facility Information added.
60 2021-07-17 vaccination site pain Pain; shoulder and armare still sore; This is a spontaneous report from a contactable consumer, the ... Read more
Pain; shoulder and armare still sore; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old female non-pregnant patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202), via an unspecified route of administration in arm right on 12Mar2021 at 12:15 (at the age of 60-years) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medication included unspecified herbal supplement/vitamins taking from over 5 years. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EM9809), via an unspecified route of administration in arm left on 19Feb2021 at 9:15 (at the age of 60-years) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine 4 weeks prior to 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 12Mar2021 at 13:45, the patient experienced pain less than one day later the vaccination, waited for the pain to resolve but it had not, and it was continuing to get worse, the patient shoulder and arm are still sore, the pain is getting progressively worse and not it hurts to lift the arm when comb the hair or to put dishes in the cabinet but it hurts to lift arm up and it hurts when the patient pick up objects of 8 ounces or more. No therapeutic measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event vaccination site pain and pain in arm was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
60 2021-07-17 vaccination site pain Pain at injection site; extreme back and body aches; headache; dizziness; low grade fever; Body ache... Read more
Pain at injection site; extreme back and body aches; headache; dizziness; low grade fever; Body aches; This is a spontaneous report from a contactable other health care professional. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733), via intramuscular route of administration in the right arm on 30Mar2021 at 15:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were included levothyroxine sodium 12mcg (MANUFACTURER UNKNOWN) taken from unknown date for unknown indication; duloxetine hydrochloride 20mg (DULOXETINE HCL), estradiol; estriol (BIEST) 4(80/20) unknown units, progesterone (Prog 80) (MANUFACTURER UNKNOWN) and prasterone (DHEA) 8mg/g (MANUFACTURER UNKNOWN) taken as hormone replacement therapy from an unknown date and multi vitamin (unspecified) taken from unknown date for unknown indication. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021, at 03:00 the patient had pain at injection site (vaccination site pain), extreme back and body aches, headache, dizziness, low grade fever. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of pain at injection site, extreme back and body aches, headache, dizziness, low grade fever was recovering at the time of this report. No follow-up attempts are needed. No further information is expected
60 2021-07-19 redness Lips swollen and Redness of face on the day of the vaccine.
60 2021-07-19 injection site pain The morning following vaccination, the patient reported pain and heaviness in middle portion of her ... Read more
The morning following vaccination, the patient reported pain and heaviness in middle portion of her left arm (the arm that received the vaccine). The patient stated that the pain was fairly localized around the elbow area, with the area of the pain starting about six inches below the elbow and stopping about six inches above the elbow. The pain made normal activities uncomfortable and became more intense as the day progressed. The patient also reported noticing occasional shooting pains originating at her shoulder and traveling down her left arm. She did not mention any systemic signs or symptoms nor did she report any areas of redness or swelling. After about a week of the elbow-area pain, the patient sought care at an urgent care provider who ordered x-rays of her arm, which did not show any detectible damage. After that visit, the patient saw her primary care doctor for the arm pain as well as for routine care. The patient noted that the provider suggested possible nerve involvement due to the vaccine and/or its administration and mentioned to the patient that the arm pain should improve over the next few months. The patient regularly sees her primary care doctor and a cardiology due to poorly controlled hypertension.
60 2021-07-19 rash with redness Pain seems to be in shoulder area and bicep area; aching/ stabbing pain; Bump reappeared with red it... Read more
Pain seems to be in shoulder area and bicep area; aching/ stabbing pain; Bump reappeared with red itchy rash; Extreme pain and mobility issues with left arm that lasted from time I received vaccine but really worsened on 4/2/21./ Could not even lift my arm any distance from body in any direction; mobility issues/ did not had full mobility; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 30Mar2021 at 12:30 (Lot Number: EN6208) at the age of 60-year-old as single dose for COVID-19 immunization. Medical history included allergies to medications and food. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included estradiol, antihistamines, vitamins and progesterone. The patient experienced extreme pain and mobility issues with left arm that lasted from time received vaccine but really worsened on 02Apr2021. On 04Apr2021, the patient went to urgent care. Went again to primary care doctor 4/8/21. It was gotten better each day but still did not had full mobility and had some pain. The patient could not event lift arm any distance from body in any direction. Extreme pain on scale of 1-10, a definite 10. Aching, stabbing pain. Bump reappeared with red itchy rash on the 07Apr2021, but was not severe. And improved today the 10Apr2021. Still not able to fully extend arm up above head. Pain seems to be in shoulder area and bicep area. At 2nd application, they prescribed Prednisone as treatment for events. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.
60 2021-07-21 eczema, rash 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 rash, itchy skin, hives Similar to allergic/immunity response; Intense and long term hives; rash; itching; burning on neck, ... Read more
Similar to allergic/immunity response; Intense and long term hives; rash; itching; burning on neck, back of neck (top of back), chest, arms, legs; Unable to sleep; 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: 8727) via an unspecified route of administration on 29Mar2021 (at the age of 60 years old) as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Known allergies was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced similar to allergic/immunity response, intense and long term hives, rash, itching, burning on neck, back of neck (top of back), chest, arms, legs, unable to sleep on 08Apr2021. Event reported as intense and long term hives, rash, itching, burning on neck, back of neck (top of back), chest, arms, legs. Similar to allergic/immunity response. Nothing at injection site or on torso or face. Unable to sleep, work, leave house. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse event included prednisone, antihistamines, steroid oil, EpiCeram. Since the vaccination, the patient has not tested for COVID-19. Outcome of the events were not recovered. Follow-up attempts are completed. No further information was expected.
60 2021-07-21 vaccination site pain pain/heaviness in left arm; pain/heaviness in left ram; pain/heaviness in left arm; sweats; chills; ... Read more
pain/heaviness in left arm; pain/heaviness in left ram; pain/heaviness in left arm; sweats; chills; diahrea; Weakness; nausea; fatigue; low tolerance to sound and light; low tolerance to sound and light; vertigo; feeling cold; headaches; muscle/joint pain in all extremities; muscle/joint pain in all extremities; diminished sense of taste; blurred vision; confusion; mood changes; increased sleep; physical agitation; difficulty breathing; Aggravation/exacerbation of underlying neurological/ pulmonary conditions; Pain in injection arm persists; This is a spontaneous report from a contactable consumer or other healthcare professional (patient). A 60-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9261) via an unspecified route of administration in Arm Left on 29Jan2021 07:00 (age at vaccination 60 years old, Pregnant at Time of Vaccination No) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, vertigo from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing None in past 5-6 years, arthritis from an unknown date and unknown if ongoing, affective disorder from an unknow