Pfizer

Onset of rash (red bumpy, itchy) on right and left forearms and right and left lower legs about 4 days after administration of vaccine dose #1. Rash continue to expand became bumpy and skin was red on both arms beyond elbows and on legs. Rash started to appear on left side of stomach. Saw physician on Monday 2/1/2021 was was prescribed course of 10 mg Prednisone and 10 mgHydroxyzine HCL. After 5 days, not much improvement, then saw physician on Friday 2/5/2021 and was prescribed MethyPrednisolone 4mg dosepk tablets and 25 mg Hydroxyzine HCL. Started dosepk on Friday 2/5/2021 but after 3 days on dosepk, rash has lessened on arms and legs but has spread across torso and some on upper arms.

aprox. 2 hours after receiving dose patient began to experience hives all over body, with more concentrated on his legs. patient self medicated with Benadryl 25mg every 6 hours with no relief of symptoms. two days later patient presented to pcp and was prescribed Benadryl 50mg every hours hours for 7 days and prednisone taper. at time of reporting patient is still experiencing symptoms of itching.

caller (son) stayed w/ the pt for about an hour after he received the vax and the pt stated the only symptoms at that time was some achiness on the arm around the injection site. Son went home after that. He tried to contact him on 3/1/2021 but wasn't able to reach him. On 3/2/21 the brother tried to contact him and wasn't able to reach him. They contacted the police dept on 3/2/2021 around 8:00 AM to do a well check. Pt was found on the couch like he had fallen asleep but was deceased. They suspect he probably expired on 3/1/2021. No autopsy will be conducted per the son.

beginning 1 day after the vaccination my patient developed an itchy papular rash o f back, scalp, chest and arms minimal relief with lyderm

allergic reaction; he developed a rash on the arm in which the vaccine was received; This is a spontaneous report from a contactable consumer (patient's spouse). A 90-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose, for covid-19 immunisation . Medical history and concomitant medications were not reported. The wife stated that her husband is 90 years old and he experienced an allergic reaction after receiving the first dose of the Pfizer COVID-19 vaccine. She stated he developed a rash on the arm in which the vaccine was received, on part of his waist and below. His doctor has told him that he would be okay to receive the second dose of the vaccine. "The doctor I took him to put him on 50 mg Benadryl 3 times a day for 7 day, then they also put him on Prednisone. We did not think he had allergy but I am thinking that about 8 months ago I used the new laundry detergent."The outcome of the event was not reported.

Dark bruise at the inner part of my right thigh, near the groin, the size of three quarters (of Dollar), my right leg became weak, could not fold, have difficulty walking

Dime to nickel sized red blotches on both shoulders, chest, back and lower back 10-12 in all. They are not raised, not itchy. There are there just in color; His lower back on Saturday that look darker than the other ones; This is a spontaneous report from two contactable consumers (one is patient and other is patient's daughter) via medical information team. A 90-year-old male patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, expiration date: unknown), via an unspecified route of administration, on left arm on 20Jan2021 at 11:30 AM at the age of 90 years old at a single dose to Prevent COVID (COVID-19 immunization). The patient medical history was none. Family medical history was none. Relevant tests was none. Concomitant medications were none. Patient's daughter stated, her father received the Pfizer vaccine on wednesday 20Jan2021 then on 22Jan2021 (Friday) patient noticed (but not sure exactly when the rashes appeared) a rash after the first dose. The rashes are described as "dime to nickel sized red blotches on both shoulders, chest, back and lower back 10-12 in all on 22Jan2021. They are not raised, not itchy. There are there just in color. No other side effects, no difficulty breathing. Should he receive the second dose? Would it be ok if they prescribed him a steroid to clear it up?" was asked. Patient's daughter says he is 90 and he received it 20Jan2021 and next week he is supposed to receive the second dose and he is not sure when they appeared but he knows that he noticed 3 days later, it could have been sooner but he just didn't look at him self in the mirror. He noticed some spots on him maybe like a nickel size on his shoulder, chest, arm and on his backside, they are a little bit red, they are flat, not raised they are not itchy. They are not causing him a problem at they are just there. But they are concerned because he has to get second dose so they are wondering should he get it still or could it cause any problems. He confirmed it was actually 2 days after the vaccine that he noticed the rash. It was Friday the 22Jan2021 when he noticed it. They are ongoing and the patient thinks the spots may be a little bit lighter now, just a little bit. Patient's daughter says she noticed a couple on his lower back on Saturday that look darker than the other ones. She says it is hard for him to see all of them. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior and Since to vaccination, the patient was not diagnosed with COVID-19. Patient had not recovered from the event rash and for other events it was unknown.

He has developed a red spot on his arm where they gave him the vaccine; The red spot is slightly warm to touch; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received second dose of BNT162B2 via an unspecified route of administration in left arm on 01Apr2021 13:00 (Lot Number: ER8734, expiration date was unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included apixaban (ELIQUIS) taken as blood thinner for a long time about four or five years now. The patient previously received first dose of BNT162B2 via an unspecified route of administration in left arm on 11Mar2021 at 13:00 (Lot Number: EN6206, expiration date: 24Mar2021) for covid-19 immunisation. He had no reaction at all after his first dose. After a couple days of second dose of BNT162B2 in Apr2021, the patient had developed a red spot on his arm where they gave him the vaccine. The red patch was about as big as his hand. The red spot was slightly warm to touch He felt that it might have increased in size over night. It was not sore, and his arm was not impaired at all. The outcome of event "a red spot on his arm where they gave him the vaccine" was not recovered. The outcome of event "The red spot is slightly warm to touch" was unknown. No follow-up attempts are possible. No further information is expected.

Pfizer-BioNTech COVOD-19 Vacine EUA was received January 15, 2021 in the left arm muscle. The next day an itchy rash appeared on the forearms. The entire next week the rash continued to increase and appear on the body trunk as well as legs and arms. We used hydrocodone 10 applied to the rash and used Benadryl 25 mg orally. We saw our Primary Care physician, who diagnosed the allergy to the vaccine. He advised not taking the second dose. After 10 days, the itchiness is subsiding as well as redness and bumps.

Approximately 36 hours after first dose, he developed generalized hives, no angioedema, no anaphylaxis. He did go to urgent care and was given oral steroids prior to my visit with him, hives had mostly resolved at my visit on 1/27/21-- although he remained dermatographic. He has no prior h/o hives or allergies

Patient (now deceased) received 1st dose of Pfizer-BioNTech vaccine around December 21, 2020 and was noticed to be scratching, fatigued, and unresponsive by a family member on December 24, 2020. He received the second dose of the same vaccine around January 22, 2021. Pockmarks and bleeding scratch marks were noted by a family member on the patient's face prior to this second dose. On January 28, 2021 a family member was alerted that the patient was suffering from severe bullous pemphigoid- a skin condition that has never been experienced by the patient, has been reported to be related to COVID-19 viral infection, and to T-cell responses promoted by vaccines. A corticosteroid was given, but did not work. Blisters developed to the point hands had to be dressed.

AT the time of the injection there was a nodule that formed under the injection site. There was no discoloration, pain, paresthesias or any subjective or objective abnormality other than the palpable "nodule." This was presumed to be a possible hematoma possibly due to puncture of a small vessel. The IM injection was not affected that we know of.

broke out with a terrible rash to his chest, groin and back with terrible itching; broke out with a terrible rash to his chest, groin and back with terrible itching; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3246 and Expiration Date unknown) via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included heart burn. The concomitant medications were reported as omeprazole (PRILOSEC) for heart burn. Patient took the Pfizer vaccine on 13Jan2021 and 1 and a half days later (evening of 14Jan2021) he broke out with a terrible rash all over his body on his chest, groin and back with terrible itching. He reports that he went to Urgent care/clinic and was prescribed prednisone for 6 days and reports that there is still a little bit there but the rash appears much better and stopped itching. The rash, it practically eliminated the rash there are still some signs of it but at the height of it, it was very vibrant and red. Also the second day he started taking another pill, Prilosec 20 mg for heart burn and he doesn't know if the rash was caused by the vaccine or the Prilosec but his question is, is that going to deter him from taking the second dose on 03Feb2021. Patient thinks he started the Prilosec either on the 14Jan2021 or 15Jan2021 and he stopped, after 2 tablets he stopped taking it because he wasn't sure, he didn't want to aggravate anything if it was caused by the Prilosec. Now asking for guidance of if he should receive the second dose. Treatment for events was prednisone. The outcome of itching was recovered in Jan2021. The outcome of rash was recovering. No follow-up attempts are possible. No further information is expected.

1 day after shot pt developed grogginess, chills in the evening, and the next morning, 2 days later scarlet red rash appeared on bilateral legs, left worse than right, ongoing, evaluated for possible cellulitis, versus vasculitis (elevated CRP), and venous stasis dermatitis, versus drug eruption (as he was placed on augmentin). seen at acute care, local dermatology and ER within 6 days. Rash abating and now followed by extensive lower extremity swelling.

91 y.o. Male with diabetes, pacemaker, hypertension, history of DVT on anticoagulation, who had his second dose of Covid vaccine on 2/17. After that, he experienced left arm swelling then developed a diffuse rash on his trunk and groin, and went to urgent care on 2/25 at that time noting blisters forming in multiple areas. At that time he was started on a 10-day prednisone taper from 40 mg down and referred to dermatology. However, he then came to the ED on 3/13 complaining of worsening of this blistering rash he described as itchy, not painful, and not associated with fevers or chills. Per his daughter he was mildly confused and complaining of fatigue. In the ED, he was afebrile with normal vital signs. WBC 13.4 with neutrophil predominance, mild anemia, acute kidney injury with creatinine of 1.7, CRP 16, lactate 2.1, Covid PCR negative. No imaging was done. Blood cultures were obtained but no antibiotics were started. He was started on high-dose Solu-Medrol and topical steroids and antihistamines as well. ID consult requested for further recommendations.

There was brusing over several days that extended down the arm, past the elbow. Photos available.; This is a spontaneous report from a contactable consumer, the patient. A 91-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 06Feb2021 at 15:00 (at the age of 91-years-old) as SINGLE DOSE for covid-19 immunisation. Historical vaccine include Dose 1, on 16Jan2021 at 15:00, Left Arm. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was a Hospital. The patient medical history were not reported. Concomitant medication were administered but drug names were not provided. Patient has no known allergies. On 06Feb2021, The patient experienced there was bruising over several days that extended down the arm, past the elbow. Photos are available. The clinical outcome of the event Bruising was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

pt notes prolonged left arm pain after second covid vaccination. pain is shooting/deep, worse at night, waking him from sleep. starts at injection site, radiates downward. exam = benign, from shoulder, no weakness, no sign for impingement. rounded 2cm soft tissue nodule which is soft, is palpated. xray neg for bony abn. very bothersome trialling gabapentin, as tylenol rtc and topical nsaids= ineffective and pain seems to be neuropathic

Face turned extremely red. Right eye almost swelled shut, nose, lips, ear swelled and very red on Friday, March 5, 2021. Swelling began to subside somewhat on Monday, March 6 after taking Benadryl.

Immediate mid section itching and hives; Immediate mid section itching and hives; Extremely swollen left arm and hand within two days; Hives turned to water blisters; This is a spontaneous report from a contactable consumer. A 91-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient had no medical history and no known allergies. The patient had no prior COVID vaccination, no COVID test post vaccination and no other vaccine in the last four weeks. The patient had unspecified concomitant medications for the last two weeks. The patient experienced immediate mid-section itching and hives. Extremely swollen left arm and hand within two days. Hives turned to water blisters, unaffected by prednisone. Blisters first appeared on arms, back and stomach and advanced to underarms and groin area. Hospitalization for five days was necessary. The events started on 09Feb2021. Intravenous steroids and antibiotics were given as treatment. The second dose of BNT162B2 was given on 18Feb2021 11:00 on the left arm. The outcome of the events was recovered. Information on the lot/batch number has been requested.

Resident returned to the memory support unit at 1500. Resident was than toileted and transferred in to bed per his request. At 1515 resident was observed face down beside bed, resident sustained a 1inX1in eccyhmotic/hematoma to the forehead. Neuro Checks with in normal limes Vital signs: 100/52, 100, 97.2, 28. Resident sent to ED for further medical evaluation via EMS.

Got shingles on his back six days after the Pfizer vaccination. Probably not related to the vaccine but wanted to report just in case.

After one shot, significant flare up of localized chronic psoriasis on buttock. Started spreading to other buttock, down inner thigh and scrotum. After second shot, his back, neck, underarms and face are covered with psoriasis and it has spread less in less severe form to legs, arms, abdomen, and probably other places I don?t know about yet. We are using sunlight, clobetisol and low gluten/no nightshade diet to try to control. Also one dose of 20 mg prednisone at ER, oral

Shingles; This is a spontaneous report from a contactable nurse. A 92-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 30Jan2021 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. Medical history included blood pressure. Concomitant medications included rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported and an unspecified blood pressure medication. The patient experienced shingles on an unspecified date too weeks later; he never had shingles before. The outcome of event was unknown. Therapeutic measures were taken as a result of shingles included "some cream". Follow-up attempts are completed. The following information on the batch number has been requested.

Shingles and Hospitalization within 30 days of vaccination. 2/18/21 PCP ordered outpt wound for shingles and unstageable decubitis ulcer (unknown onset date of shingles). Seen in ER on 2/19 and admitted discharged to rehab unit on 2/23/21. reported 1-2 week history of generalized weakness and frequent falls, poor oral intake and shingles. 2/19/21 pt c/o heart racing and irregular. Found to be in Afib with RVR. 2nd dose of Pfizer given 3/19/2021 went to ER 3/24 for pneumonia.

diabetic; He didn't eat much last night and didn't eat this morning.; temperature was 100.3.; Nausea; feeling dizzy; Rash; face real red; shaky and jittery; shaky and jittery; This is a spontaneous report from a contactable consumer. A 92-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0167), via an unspecified route of administration in left arm on 29Apr2021 at 14:30 (at the age of 92-years-old) as unknown, single dose for COVID-19 immunization. Medical history included patient first diagnosed as pneumonia, reporter was unsure pulmonary lung infection and pneumonia are the same and treated 3-4 weeks ago for a pulmonary lung infection and type 2 diabetes mellitus. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No adverse event prior vaccinations. Patient did not perform any relevant test. Patient took a lot of medications after being in rehab but concomitant medication was not reported. Vaccine was not administered at (Privacy)Facility. On 30Apr2021, the patient experienced nausea, feeling dizzy, temperature, developed rash, red face and shaky and jittery. Patient had been bringing up stuff from lungs some of the stuff bothers and makes patient nauseated, didn't eat much last night and this morning. Patient was diabetic so she thought it might be related to a sugar thing. Patient won't drink any water and temperature was 100.3. She put a cold towel on face and it came to normal color and face was real red before, on 30Apr2021. Diabetic on an unspecified date. Reporter asks would that condition aggravate the side effects of the vaccine. Patient did not visit to physician office and emergency room. The patient underwent lab tests and procedures which included body temperature: 100.3 on 30Apr2021. The outcome of the event nausea was recovered and rest of the events are unknown. Follow-up attempts completed. No further information expected.

PER SPOUSE, HE HAD A CUT ON HIS LEG THAT DID NOT STOP BLEEDING. THEY WENT TO CLINIC TO GET IT CAUTERIZED. DAY LATER HIS BODY HAD MULTIPLE BRUISES, THEN HE WAS EVEN BLEEDING FROM HIS PENIS. AT HOSPITAL THEY TOLD HIM HE HAD LOW PLATELETS AND WAS BLEEDING OUT. HE WENT INTO HOSPICE AND PASSED AWAY ON 5/8/2021

death Narrative: 92 yo male seen in clinic on 12/30/2020 for transfusion, hbg 6.9. PMH includes HLD, CKD, myelodysplastic syndrome, DM, prostate cancer, HTN. Pt also received COVID19 Pfizer vaccine the same day. The patient denied any prior severereaction to this vaccine or its components. Post-transfusion, patient had a mechanical fall (per patient he was seated and used the cane to help him stand. However the cane slipped on the floor causing the patient to fall, patient hit his head and injured his right hip, no loss of consciousness at the time). Rapid response team was called and patient was admitted to the ED. Pt was found to have subcapital right femoral neck fracture, scalp contusion, and TBI (per ED provider's note). Ortho evaluated and said patient wasn't a surgical candidate. During his hospitalization, patient tested positive for COVID19 on 1/12/2021, pt was asymptomatic at the time. On 1/13/2021, pt exhibited mild URI symptoms, no respiratory distress. He was started on cetirizine, Montelukast, albuterol, and inhaled steroids to manage his symptoms. Dexamethasone was started on 1/14/2021. Chest Xray was ordered on 1/17/2021, pt's respiratory was slowly getting worse, resting O2 sats were in the high 80s and low 90s with IS. On 1/18/2021, CXR shows patchy bilateral airspace opacities suspious for pneumonia of bacterial or viral etiology. Pt was started on remdesivir 01/18/2021 (5 doses, from 1/18-1/22/2021). Pt required 5-6 LPM of oxygen at rest. Pt was then transferred to the ICU. His oxygen demand continued to increase and his condition worsened. On 2/14/2021, pt started to desat into the 70s on max high flow. Patient/family agree to comfort care. Medical cause of death was listed as "acute hypoxic respiratory failure due to COVID19." Patient expired 1/24/2021.

Low platelets, thrombocytopenia, bleeding from mouth, large bruising, purpura, petechiae, rash of pinpoint-sized reddish-purple spots on lower legs. Treated with at least 2x2 units of platelets, IVIG for several days (at least), diagnosed as ITP, immune thrombocytopenia. Developed aspirational pneumonia in hospital. Admitted with platelets at 1x10^9/L; discharged on day 5 with 79x10^9/L. Patient had ITP 10 years earlier and was recovered from it.

Sleeping more than usual and off balance. He fell and split his head on right side. Called rescue and brought to hospital. Had a hematoma and was sent to rehab for two weeks. Lost hearing to the right ear which was his better ear. Had second shot on March 15th and tired sleeping most of day. Two days after shot, he went to get up and fell cuttiing his head in the back. We were able to stop bleeding, applied ice and facility gave us bandaging material. Still healing and sleeping most of the day and night.

Pt presented to the ER 3/10/2021 c/o inability to ambulate and progressive weakness and muscle pain. Pt received his 2nd covid 19 vaccination on 2/15/21 and was dx with shingles a week later of the l ear. Pt reported he was weak after vaccine and never really got better progressing to inability to ambulate and groin/muscle pain resulting in the er visit. He was evaluated by PT and was found to be 2 assist with rapid decline. He was living independently prior to this using no assistive devices. He was admitted to the hospital and ultimately discharged to rehab on 3/12/21 where he remains presently according to the daughter.

shingles in his forehead and close to his eye but not in eye; lesions; swelling, pain and inflammation; swelling, pain and inflammation; swelling, pain and inflammation; This is a spontaneous report from a contactable consumer. A 93-year-old male patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number: EL3302), via unspecified route of administration on 22Jan2021 at 14:00 (at the age of 93-years-old) as a single dose for COVID-19 immunisation. It was reported that patient had a lot of medical conditions and takes a lot of medications (unspecified) (but nothing she thinks is related to the vaccine). Additional vaccines administered on same date of the pfizer suspect was none. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 07Feb2021 patient had lesions showed up and he was diagnosed with shingles he had symptoms 2-3 days prior: he was on a medical treatment with a viral medication, prednisone, ibuprofen and Tylenol. On Tuesday they went to see his ophthalmologist because he has shingles in his forehead and close to his eye but not in eye, his ophthalmologist said that after 10 days with the viral medication and 5 days with prednisone, he should be able to get the second dose of the vaccine. She would like to know if the vaccine could have caused him shingles. He was on a viral medication and was put on prednisone for swelling and inflammation on an unknown date in Feb2021. The patient was also alternating Tylenol and Advil for pain. The patient did not visit emergency room. The outcome of the events lesions, swelling, pain and inflammation was unknown while for shingles was not recovered.

Injection site pain/discomfort Narrative: From 12/17/20 COVID-19 Screen note at23:06, vet reported some discomfort to right upper arm (where received vaccine) but that the pain was "ok". No additional pain reported in subsequent notes.

Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium; symptoms lasted 1 day

he wasn't attracted to food for a day; arm began hurting at the right top of his arm and right shoulder area; planned in 2 weeks, will be his second COVID-19 Vaccine shot; This is a spontaneous report from a contactable Consumer(patient). The 94-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm on 08Jan2021 at single dose for COVID-19 immunization in a nursing home. Medical history included he was hospitalized with the COVID-19 Virus and pneumonia in Apr2020. He was in the hospital for 2 weeks, the hospital treated him one COVID-19 Vaccine (he doesn't know what they did in the hospital when he had the COVID-19 Virus in Apr2020), then he went to rehab for 6 weeks, he was gone from his residence for a total of 8 weeks, he also had throat problem, and a swallowing issue for a long time before he received the COVID-19 Vaccine, he had a constant clearing of his throat. He had tiny bits of bacon that may cling on to the edge of his throat, and block his swallowing temporarily. Once he cleared his throat, he went back to swallowing. When he cleared his throat, it took care of his swallowing problem, but not permanently. The patient's concomitant medications were not reported. The patient experienced His arm began hurting at the right top of his arm and right shoulder area after receiving the COVID-19 Vaccine (where he received the COVID-19 Vaccine) on 08Jan2021. He said everything was OK, he was feeling some pain, but the pain was nothing to even keep him awake. The next day after receiving the vaccine(09Jan2021), he had no desire for any food, and didn't eat anything, he didn't want anything to eat/ he wasn't attracted to food for a day. He was having a recap of the effect of getting the Vaccine shot. He said the COVID-19 Vaccine shot affected his stomach's desires and so forth. He had been eating now for the past 2 days. There was no treatment received. He also clarified under the COVID-19 Vaccine program with Pfizer, the COVID-19 Vaccine shot planned in 2 weeks, will be his second COVID-19 Vaccine shot. He said the COVID-19 Vaccine is so new, and people are on a tight schedule to get the COVID-19 Vaccine shot. Outcome of arm began hurting and Appetite lost was recovered in Jan2021. Information on the lot/batch number has been requested.

OX SATURATION AS LOW AS 74, TEMPERATURE OF 100.5, DYPHORETIC, SHAKING, HOT TO TOUCH, PALE, FEELS TERRIBLE COUGHING

sight impairment/did not see very well/unable to read during report; injection site pain; tiredness; muscle pain; feeling unwell; frequent urination every 15 minutes; signs of severe allergic reaction including dizziness, weakness and sight impairment; signs of severe allergic reaction including dizziness, weakness and sight impairment; signs of severe allergic reaction including dizziness, weakness and sight impairment; This is a spontaneous report from two contactable consumers. A 95-year-old male patient received 1st dose of BNT162B2 (Pfizer BioNTech COVID-19 Vaccine ), via an unspecified route of administration in upper right arm on 16Jan2021 11:00 at single dose for vaccination. Medical history included diabetes from 1950 (also reported as 1991) and ongoing. There were no concomitant medications. The patient experienced not in very good shape/terrible reactions on 16Jan2021 12:00. Requested information regarding events relative to the product. Further clarified this event as to include injection site pain; tiredness; muscle pain; feeling unwell; frequent urination every 15 minutes; signs of severe allergic reaction including dizziness, weakness and sight impairment. Patient clarified that all of these events had onset of about 12:00pm-1 hour after Pfizer BioNTech COVID-19 Vaccine administered (16Jan2021 12:00) and had for the most part remained the same since onset, but for sight impairment was on 18Jan2021. The patient did not see very well; caller had to read some of the information provided in this report from forms that patient was unable to read during report. The muscle pain was marginal. The weakness was the same or worse. He wanted a pain reliver or pill. Patient did not plan to get the second dose due to adverse events. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No emergency room/physician office visit. Family medical history relevant to the events was none. The outcome of injection site pain was recovered on 18Jan2021, tiredness, feeling unwell, dizziness was not recovered, muscle pain, frequent urination every 15 minutes was recovering, severe allergic reaction, weakness, sight impairment was unknown. Information on the lot/batch number has been requested.

L hand edema, hematoma which burst and caused bleeding sending pt to the ER for pressure dressing and 2 stitches. L hand and arm progressively got more edematous and bruised looking (severely black/blue/purple) and the hand continued to bleed and swell on 2/6/21. Severe arterial and venous issues and apparent blood clots. On 2/7/21 there were also lumps noted on left inner thigh. Pt. stopped eating or drinking on 2/8/21 and expired on 2/12/21.

Per his son: LEFT ARM TURNED BRIGHT RED FROM HIS SHOULDER DOWN TO HIS ELBOW Reportedly has improved slowly; son was concerned as his dad did not have this reaction to the first dose, and is on Plavix.

On March 7, early morning, patient's right chest was bright red with a dense pancake size rash over his original rash.

Eczema; rash/ Full body rash; This is a spontaneous report from a contactable consumer (patient's son). A 95-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in arm right on 06Mar2021 (at the age of 95-years-old) as single dose for COVID-19 immunisation. The patient's did not had any medical history including any illness at time of vaccination. The patient's concomitant medications were not reported. It was unknown whether the patient had history of any previous immunization with the Pfizer vaccine that would be considered as suspect. The patient did not administer any additional vaccines on same date of the Pfizer suspect. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE on 11Feb2021 (at the age of 95-years-old) for COVID-19 immunisation. The patient did not receive any prior vaccinations within 4 weeks. The consumer reported that post 2nd dose vaccination, the patient developed a rash that has been ongoing for 12-14 weeks now. The rash initially appeared on his torso and his entire body (full body rash). Currently, some of which has subsided in some areas but the rash was still evident all over his body. The patient went to his primary care doctor and also a skin doctor and they tried to sort out what it could be. The patient's physicians tried multiple treatment regimens to treat that but to no success. The consumer reported that it seems to coincide with the shot. The patient has had no medication changes. The consumer was not necessarily looking to report the side effects at that point as he didn't know if the vaccine was the cause, but they have not been able to explain it. The consumer was unsure of exact date of the event. However, he thought it was 12Mar2021. The consumer further stated that it was either the end of March or the middle of March. He attempted to confirm the rash broke out on rash on a Saturday with his father. The patient underwent biopsy a couple of weeks ago (May2021), the rash was tested and he thought it came back as eczema. The patient went to urgent care first and followed up a week later with his primary care doctor regarding the rash. The events required a visit to emergency room and physician office. There was no family medical history that pertained to the rash. The consumer would like to know if that has been reported side effect in relation to the administration of the vaccine and would like to seek treatment recommendation or remedy in line with the event. The outcome of all the events was not resolved. Information on Lot/Batch number has been requested.

Immediate hardened bump at injection site. 15 minutes later, purplish bruising. 2nd day post vaccination bruising noticed but diminished.

Both nipples on my chest, they hurt. I would say they are sore.; Area on the right leg itches; Does not feel well; This is a spontaneous report from a contactable consumer (patient's wife) and a non-contactable consumer (patient). A 96-year-old male patient received the second dose of BNT162B2 (BNT162B2, Solution for injection, lot number: 5L3248, expiry date: not reported), via an unspecified route of administration, on 03Feb2021 at a single dose for COVID-19 immunization. Medical history included thyroid (disorder) and triple bypass a number of years ago. Concomitant medications included apixaban (ELIQUIS), dutasteride (DUTASTERIDE), famotidine (PEPCID), fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), furosemide (FUROSEMIDE), nebivolol hydrochloride (BYSTOLIC), simvastatin (CRESTOR), and he also takes cholesterol and thyroid medicine. The patient previously received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EL0142, expiry date: not reported), on 12Jan2021 for COVID-19 immunization (at the age of 96-year-old). The patient reported that both of his nipples hurt and his right leg itches on 07Feb2021. He further clarified, "My wife just told you that the symptoms that I am experiencing are, both nipples that would be the both nipples on my chest, they hurt. I would say that they are sore, and I have a area on the right leg itches and that just started. All these symptoms just started. Otherwise, I am okay." The patient's wife also reported that the patient does not feel well at the time of the report. The patient did not receive any treatment for the reported adverse events. Outcome of the events was unknown.

Bell's Palsy diagnosis. Following 2nd administration of Pfizer COVID vaccine, 97 year old male found on the floor by housekeeping. Sent to ER due to cuts and bruises. MRI ruled out Stroke. Patient presented with a droopy eye & mouth on one side of face. Complained of ear pain on the same side. Patient also tested positive for COVID without any presenting symptoms via PCR test. Patient's will to live has decreased.

About 5 days after second dose he developed a red rash.. blotchy. Then a few days later he was very weak, especially his hands and had difficulty swallowing. Today the rash developed liquid filled pustules.

Puritis without rash to upper back and upper right arm. The upper back resolved withing a few hours. The upper right arm persists. Thirdy days after first COVID vaccine. No reaction from second dose which was given 1/21/21 in the left arm