Pfizer

DEVELOPED RASH ON NECK AND SHOULDERS. RECEIVED 25MG DIPHENHYDRAMINE BY MOUTH AT 10:15AM. RASH RESOLVED BY 10:30AM

Sunday Morning (2:00 AM) 01/24/2021 woke up with severe chills (body hot), breathing hard. Lasted about 45 minutes. took Advil and used the CPAC to calm my breathing down. Then slept until 9:00 am. But after I woke, I felt tired the rest of the day. I am doing fine now. I am not sure if this was a side effect of the covid vaccine or not. But I thought I let you know.

I write today because On January 20, I received my first Pfizer covid vaccination. I have felt no side effects but when I read the story of the doctor who died of bleeding after that vaccination, I became concerned because I do get minor petechiae from the blood thinner and then yesterday (1/25) I noticed a petechiae different from the rest. It was on my back and was bigger than the few tiny pinpoint ones from the medication. I am wondering if the vaccine made the difference and if my platelet count is going down. Is it possible that the vaccine might interact with blood thinners and create Thrombocytopenia? I have never heard of that disease before, but I think it can exist unknown or maybe be started by the vaccine. I will be watching for any additional petechiae, but would it be good to get a platelet test to see if something has gone wrong? The doctor with zero platelets, no symptoms and death by bleeding has caused me concern and if blood thinners, my eczema or undiagnosed Thrombocytopenia cause issues for vaccines, that information would be good to know. I am a 76 year old male in generally good health. My fitbit walking target is at least 4 miles/day and I usually reach that. At 5? 9? and 172 pounds I enjoy golf weekly when winter is over. Two issues do exist. Twenty seven months ago while searching for the cause of some PVCs the doctors put in a stent and scarred a diagonal artery causing what they said was a heart attack. Recovery was quick and subsequent tests indicate the heart was healed and working fine. I have no heart symptoms, but since then have been on first Brillinta and now Clopidorgrel (Plavix) plus baby aspirin. Second, last August I was diagnosed with eczema which might be psoriasis which I think is autoimmune related. It is annoying at times but the prescription cream helps.

Weak; Chills and completely ice cold; Chills and completely ice cold; Really sore in injection arm; Joints hurt; This is a spontaneous report from a contactable consumer (patient). This 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 12:00 on arm Left at single dose for covid-19 immunisation. Lot number is EL3, then a number he cannot read, followed by 46. Medical history included type 2 diabetic. No concomitant medications. His joints hurt on 11Jan2021 in later afternoon. It is not worse, but not better. On 12Jan2021, chills and Woke up during night completely ice cold. Had to get a blanket and finally went back to sleep. Feels weak. Doesn't know what happened. Still feels chill. After midnight on the 12Jan2021. Is a little bit better. He was really sore in injection arm on 11Jan2021. Outcome of the event Joints hurt was not recovered. Outcome of the events Chills and completely ice cold was recovering. Outcome of the event Really sore in injection arm was not recovered. Outcome of the event Weak was unknown. Information about lot/batch number has been requested.

a sore developed under the end of the band aid strip used to cover the injection site. The injection hole disappeared but the sore and some redness around it still present. The sore is about 1/8" around. Both upper arms are sore.

Rash and itching on arm and shoulder in area of injection site. Broken skin (not due to scratching) Symptoms still ongoing

Pain where I had the vaccine; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old (also reported as 72-year-old, pending clarification) male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in the left arm, on 20Jan2021 09:00, at single dose, for COVID-19 immunization, at a public health department. Medical history included diabetes, blood cholesterol abnormal (reported as cholesterol) and blood pressure high (reported as high pressure, pending clarification). The patient had no known allergies. Concomitant medication included amlodipine, atorvastatin, cyclobenzaprine, and losartan potassium (COZAAR). The patient did not have other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient reported he had "pain where I had the vaccine" on 20Jan2021 at 14:00. No treatment was given for the events. The outcome of the event was not recovered.

rash which slowly spread from chest to entire upper torso and next day spread to buttocks and upper thighs

Pronounced soreness near injection site; Mild flu-like symptoms; vivid dream; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration in left arm on 22Jan2021 21:30 at a single dose for COVID-19 immunization. Medical history included none. Concomitant medication included levothyroxine sodium (THYROXINE), vitamin D, tamsulosin. The patient experienced pronounced soreness near injection site, mild flu-like symptoms, and vivid dream on 23Jan2021 01:00. Pronounced soreness near injection site. Mild flu-like symptoms strong for two hours and then diminishing with time. Very, vivid dream, detail rich, color, flashing light. No treatment received for the events. The outcome of the events was recovered on an unspecified date. The events were assessed as non-serious. Facility where the most recent COVID-19 vaccine was administered was Hospital. No other vaccines received within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been been tested for COVID-19.

Pain the underneath part of left arm, pain in tendon of left ankle and rash on left side around to the middle of back which itches severely and is very tired

Rashl beginning on pack and spreading to other areas over several days. Received second vaccination on 2/10/21. Went to ER on 2-12-21 for treatment. Condition now resolved. Meds: Epinephrine, Claritin, Prednisone. CBC blood test.

This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration at the left deltoid on 26Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the Pfizer covid vaccine on 26Jan2021. When he came home that day his left arm swelled up and had a knot at the injection site. States he went right out, clarifies he went to sleep for hours. The next day (27Jan2021) when he woke up, he rubbed the area and it was sore. Three days ago (30Jan2021), he started running out of breath, he would walk to the mailbox and have to stop since he was out of breath. He never had that happen before. He was not sure what it was or if something else going on. He would have no breath whatsoever if he gets up to walk. When he was sitting still he was ok. If he gets up to walk to the bathroom, he was out of breath by the time he gets to the bathroom. States he was not short of breath as long as he was not doing anything. States it was crazy though when he starts walking and he gets out of breath. This has never happened to him before. He does not know if it was the vaccine or something else. He saw the shortness of breath was one of the side effects. He wants to find out what he should do and if he should go to the hospital. Advised to contact hcp. He asks if he was supposed to go back for the second shot. He has an appointment with his doctor in the next two weeks for all the medications he takes. The outcome of the events was unknown.

Patient had itching after the 2nd dose Pfizer vaccine was given. Given diphenhydramine 25 mg PO. Patient had reported hives after first dose.

Sore arm at the injection site; Exhaustion; Achy body; Low-grade fever; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 26Jan2021 14:30 at single dose for Covid-19 immunization administered at Hospital. The patient's medical history Have a stent in my heart, mild heart attack 2+ years ago, and Covid-19. The patient's concomitant medication included acetylsalicylic acid (BABY ASPIRIN) at 83 mg, metoprolol, and evolocumab (REPATHA). On 26Jan2021 21:30, the patient experienced Sore arm at the injection site, exhaustion, achy body, low-grade fever. The patient did not received treatment for the events. The reporter assessed the events as non-serious. The outcome of the events was recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19

on 2/13, noticed red band across eyelid of right eye and eye looked a little off. Didn't think much of it. Week of 2/21 noticed rash on forehead on right side. 2/28 rash had spread to top of head and right forehead and right eye is now swelling.

Patchy red skin on both thighs. Slightly itchy.; Patchy red skin on both thighs. Slightly itchy.; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 21Jan2021 at 09:45 at a single dose on left arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced patchy red skin on both thighs, slightly itchy on 21Jan2021. Therapeutic measures were taken as a result of both events (steroid cream). The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Quite tired; He has a slight headache; he felt achy/Body aches and pains; Injection site pain; Had a fever 99.7F, 99.9 fever, later 101F; discomfort/slight injection site discomfort; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number EL9263, expiry date not reported), intramuscular on 26Jan2021 12:00 at a single dose in the left arm for COVID-19 immunization. Medical history included years ago he did have an issue with a lung disease when he went to (country name); he did have COVID 19 in Mar2020 and he recovered from that; high blood pressure; psoriatic arthritis diagnosed 30 years ago; and non-smoker. Family medical history included that they are all smokers in his family, and he is not. His sister died of pancreatic cancer and his mother died of oat cell lung cancer. Concomitant medications included valsartan (DIOVAN 160 mg) for high blood pressure at 160 mg, daily started 3.5 years ago to an unknown date; and patient was taking some health store vitamins. The patient previously took infliximab (REMICADE) on unspecified dates 5 years ago as Arthritis medication administered IV and apparently it lowered his immune system and he wound up in the hospital with a lung infection. He recovered completely. He does not have a lot or expiration. It was administered in the doctor's office and he does not go to that doctor anymore. It was reported that patient had no prior vaccinations (within 4 weeks). He had second dose of Shingles vaccine and it was close to 4 weeks ago. Shingrix administered on upper left arm received it at an in-store clinic, and patient had slight injection site discomfort. No other vaccines administered on same date of the Pfizer suspect. Patient received the first dose of the Covid 19 vaccine on 26Jan2021 at noon, with just a bit of discomfort. He seemed to be fine except slight injection site discomfort, also reported as injection site discomfort on left upper arm, on 26Jan2021. Later that night (also reported as last night 26Jan2021 23:00) he felt achy, he had bad body aches and pain and still has it this morning. Injection site pain worsened last night and now it has improved. He woke up in the middle of the night, and had a fever 99.7 F, 99.9 fever and later it went as high as 101 F (26Jan2021). He took Advil and Tylenol. The body aches improved after he took 2 Tylenol when he took his temperature. He took temperature about 1.5 hour ago. He went into bed and waited and took it again about 1/2 hour ago and it went up to 101. He then took Tylenol and took his temperature again. This morning (27Jan2021) his temperature was now back/down to 99.3 F. He was still feeling aches but not as bad as before. He might still have a slight temperature now, but it has improved. He believed vaccination was given in the muscle because it was in the upper part of his arm where the skin is thinner. He had a slight headache and was quite tired (27Jan2021). Patient asked if there's anything he should do or be concerned about. He was scheduled for the second dose on 16Feb2021 and he heard that the second dose was stronger than the first one, that after the second dose there may be more side effect, and he wanted to know if this is true and wanted to know if he can get the second dose. Therapeutic measures were taken as a result of the events discomfort/slight injection site discomfort, he felt achy/body aches and pains, fever, and injection site pain. Patient had no ER or physician's office required. The events discomfort/slight injection site discomfort, he felt achy/body aches and pains, fever, and injection site pain were recovering. The outcome of the event tired and headache was unknown.

Rash over entire body except the face. Massive hives under arms and on elbows and stomach. Treated with Prednisone and benadryl for 10 days. Mostly cleared after 5 days of 2 prednisone per day, changing to 1 per day after that.

Pt reported feeling faint approx 10 min after receiving vaccine. He disclosed that he had not eaten anything before the vaccination. Monitoring revealed BP of 150/74, HR 52, O2 93%. He felt better after 10 min and was released to self. In follow-up he stated he went home and had something to eat and felt much better. Only sequela was pain at site if injection.

Numbness and tingling in right leg about 4 days after 2nd vaccination, moved to right foot. Then moved to left foot but didn't affect left leg.. Feet are cold now, legs are okay now, just the feet. Hands, lips, & tongue, & face feel numb and tingly too. Spoke with Dr on phone. Client stated he took Tylenol for a couple of days after vaccination. Stated injection site is black & blue. Client still dealing with numbness & tingling. Waiting to speak with Dr again. Phone call to office.

No problem at first 9 days after injection I woke up with a very sore spot of the injection/his arm is hurting, the same arm he received the injection in; his arm is hurting, states it is his left shoulder and arm, the same arm he received the injection in; his arm is hurting, states it is his left shoulder and arm, the same arm he received the injection in/could be a sign of an infection; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: El3247; expiration date: unknown) at vaccination age of 76-year-old via an unspecified route of administration in the left arm on 02Feb2021 12:00 at a single dose for covid-19 immunization. The patient's medical history concomitant medications were none. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the COVID-19 vaccine in a public health clinic/veterans administration facility. The patient reported that there was no problem at first 9 days after injection. He woke up with a very sore spot on the injection on 11Feb2021. The event did not received treatment for the adverse event. The patient considered the event was non-serious. The patient has not been tested for COVID-19 since the vaccination. The patient further stated that got the Pfizer Covid vaccination on 02Feb2021, but he had no reaction and everything was fine. He mentioned that this morning (11Feb2021) which was 9 days later, his arm was hurting. He stated that it was his left shoulder and arm, the same arm he received the injection in which was given the injection by the employer. The patient wanted to know if it is normal to experience this type of reaction 9 days later. He was wondering if it could be a sign of an infection. The patient was encouraged to reach out to his healthcare provider. The outcome of the events was not recovered.

Fever 100.8 Chills Injection site pain 2days Body ache 3 days Fatigue 4 days All went away on their own

Body rash appearing a few days after first shot. I tried to treat myself with anti rash/itch over the counter medication. Finally i was seen at urgent clinic and treated for ALLERGIC CONTACT DERMANITIS and RHUS DERMATITIS on 2/22/2021. I asked about possibility of adverse reaction to vaccine. They said not likely. Informed them that i was getting second shot on 2/23/2021. They said mention this rash. I did and was told not to worry by personnel administrating the second vaccine

My body ached everywhere. This was similar to the onset of a cold. The injection site on my left shoulder started to get stiff and aching according to #5 above. This spread throughout my body. The discomfort subsided by 9:00 a. m. on 03/12/2021. The duration seems to have been 36 or so hours. I feel good as of 11:30 a. m. 03/12/2021. I am providing this information if it is useful for any CDC purposes statistical or otherwise.

Very red face; Broke out in rash that eventually covered my whole body; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: El3248), via an unspecified route of administration from 29Jan2021 11:00 to an unspecified date at single dose for covid-19 immunization. Medical history included 2 knee replacement, diabetic, high blood pressure, anemic and allergies to penicillin. Concomitant medication included insulin, paracetamol (TYLENOL) and metformin. The patient previously took Benadryl and experienced drug hypersensitivity. The patient experienced very red face and broke out in rash that eventually covered my whole body on 29Jan2021 at 18:15. The outcome of the event was not recovered.

Pain in left calf Had ultrasound on left leg 3-16-2021 DX: hematoma left leg Told to apply hotpack q20 min off & on

Sore developed under the bandaid placed on injection site; there was a big red dot and it was itchy; there was a big red dot and it was itchy; Also both my arms are stiff and i have some pain.; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot #: El9263), via an unspecified route of administration on 28Jan2021 09:30 at single dose at Left arm for covid-19 immunization. Medical history included stents for my heart. Concomitant medication included metoprolol, acetylsalicylic acid (BABY ASPIRIN), furosemide and clopidogrel. The patient previously took gefalexin and levaquin and experienced drug hypersensitivity. On 29Jan2021 08:00, sore developed under the bandaid placed on injection site and the patient reported as, he received first dose on 28Jan2021, right afterwards the next morning I removed the band aid they had placed and there was a big red dot and it was itchy. Also both my arms are stiff and i have some pain. I got the injection on the Left arm but the Right arm feels the same. I spoke with my doctor he told me to put bacitracin on it for few days but it's still there. It's less itchy but the red dot is still there its 2-3 inches from the injection site and also said, I think I'm going to skip the second dose. A red sore developed under the band aid that was applied to cover the injection site. It is under the right edge of the band aid. The area where the exact needle penetrated is healed. Both arms are sore at the top by where they meet the shoulder. Outcome of the events were not recovered.

popular erythematous rash in patches, scattered from right shoulder down the right arm, with mild itching. no edema. no vesicles. no pain. no treatment required. suspicious for early shingles vs "covid arm." started on day 3 after vaccine, and worsened over next several days.

Rash (spots) appeared on legs, stomach and arms; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 11Feb2021 (at the age of 76-year-old) as single dose for COVID-19 immunization. Medical history included ongoing esophageal cancer. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included zolpidem (MANUFACTURER UNKNOWN), ondansetron (MANUFACTURER UNKNOWN), chemotherapy and radiotherapy, both for esophageal cancer. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Feb2021, the patient experienced rash (spots) appeared on legs, stomach and arms, and that rash does not itch, burn or cause discomfort. No treatment was received for the adverse event. The clinical outcome of the rash (spots) appeared on legs, stomach and arms was not resolved.

Within 1/2 hour of vaccine, patient states he had fever, chills, shortness of breath, aches, throughout the body - "eyeballs hurt" - "hair hurts" loss of appetite, lost his sense of taste, increased hoarseness, decrease O2 saturations.

pt states that a few days after he got the Covid 2nd dose his arm became sore around the injection site. Pt says it started throbbing and sore and has been this way for almost 2 weeks but is not getting any better. He says the throbbing very painful. will contact his PCP for medical advice.

This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 30Jan2021 08:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that on 01Feb2021 07:00 AM patient experienced rash and welts mostly on right arm. Some on other parts of body. Patient did not have COVID-19 prior vaccination, Patient did not COVID-19 tested post vaccination. Outcome of the event was not recovered. Information on the lot/batch number has been requested.

1. Rash on both arms 2. some hair loss on left forearm 3. worsening of arthritis in hands, wrists, knees & back

Went to urgent care 4-5-2021. Doctor said I have shingles on my right side of my head. Doctor told me to report it sinice I have had 2 vaccine shots.

Vaccine kicked my Restless Leg Syndrome into high gear, making it impossible to sleep. Did not sleep for 2 nights in a row, until finally the reaction started to subside. Also, the vaccine gave me a minor case of hives rash. This has not subsided yet. But the RLS is NOT a minor problem, it is major, to me.

It was itchy like crazy; both of his arms are as stiff and achy at the top; both of his arms are as stiff and achy at the top; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received bnt162b2 (BNT162B2, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL9263) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient had two side effects and the second shot would be coming up and he was nervous about what he should do. The main side effect is that they put a band aid on where injection was to protect site. The next morning, he took it off and on the edge of the band aid, there was a red dot about 1/8 to 1/4 inch around. It was itchy like crazy, he did not scratch it. That dot was staying there. The doctor told him not to do anything to it and just put a little bacitracin on it. He did not provide any information for the Bacitracin such as a dose, lot or expiration. The next side effect was both of his arms which was stiff and achy at the top. The injection arm feels exactly like the right, but only the left one got the injection. He would like to know if he should be concerned with second dose or not. The outcome of the events was unknown.

I had the second shot at the same place on 2-11-21. At the time, I only had soreness of the left arm at the injection site and virtually no other symptoms except a mild headache for a few hours. However, during the month or so between the vaccines and post-vaccine period, I developed pain in both shoulders with moderate-severe rotator cuff symptoms. This was pain in reaching in almost any direction. Also, I began to notice heaviness in both upper legs, front and back, which in a week or so progressed to tiredness and then to achiness, and finally to pain when I would squat, bend over, or get up from a chair. I have never had either symptom before.

This is a spontaneous report from a contactable physician. A 76-year-old male patient received BNT162B2 (BNT162B2), dose 1 intramuscular on 25 Feb 2021 (Batch/Lot Number: EN6198) at single dose for COVID-19 immunization administered at clinic. Medical history included hypertension, blood cholesterol increased, myocardial infarction, colon cancer (had surgery for that and also had chemotherapy), coronary artery disease (30% blocked coronary artery), covid-19 from 19May2020 to an unknown date. Concomitant medication(s) included lisinopril for hypertension; amlodipine; rosuvastatin for blood cholesterol increased; evolocumab (REPATHA), subcutaneously at 140 mg (twice a month) for blood cholesterol increased. The patient reported, he was diagnosed positive with COVID-19 on 27May2020 from which he seem to have recovered without any residues of symptoms or side effect. He received first Pfizer COVID vaccination at noon time this past Thursday 25Feb in a vaccination clinic set up, the following day Friday the 26 he woke up the next morning and entire body was so sore from head to toe and could hardly get himself out of bed, but when he got up, he was having difficulty walking, so anyway he stayed in bed all day on 26 and 27. He initially had a slight temperature, some chills, slight cough, runny nose and those symptoms except for the cough seem to have resolved, what hasn't resolved is about every 30 or 40 minutes or so he had been having to urinate ever since 26Feb2021 night, his mouth has been constantly very dry. Still urinating every half hour 45 minutes and ongoing. Mouth has been very dry and had a couple of areas where it seems like maybe he had bit his lip or something, maybe when he was sleeping. It was nothing like that in mouth anymore but the mouth is still constantly so dry like dehydrated and no matter how much of fluid he drank that doesn't seem to help it and what in fact has also caused was on yesterday morning he had been a little constipated on Friday night and then yesterday morning had a severe case of diarrhea. Now he had not had another bowel movement since yesterday morning as no appetite and feeling so lousy, and so tired and fatigued. He had been feeling even much worse since getting the vaccine. He still feels very fatigued, very sore all over, very tired, still have the slight cough and he would say that's about it. Outcome of events for cough, pain and tiredness was not recovered and for the rest of the events it was unknown. No follow-up attempts are possible. No further information is expected.

Shingles Two rounds of steroids and Valtrex Pain, then rash, very sensitive skin, cured inapprox. 4 wks. after starting treatment.

a little soreness to his arm after injections/ injection site soreness/arm soreness; viral infection warts came off/ one came off and then another started peeling up off his skin/the third one was peeling up at the edges/ Unexpected therapeutic benefit; he pulled up on it and tore it off and it bled a little; This is a spontaneous report from Pfizer-sponsored program from a contactable consumer (Patient). A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 (Lot Number: EM9809) at the age of 76 years old as single dose for COVID-19 vaccination. Medical history included Bypass surgery from 2014, stent placement from 2014 (got this within 2 days of his bypass), Diabetic from 2001 and ongoing; viral infection warts on his right arm from 2020 (had been there about a year) that were 3/8 of an inch to a half inch thick, and were always hanging on stuff. The patient's concomitant medication included unspecified medication (patient had been on the same meds for years. No further details provided about his other medications). Caller said he had no recent vaccinations the day of or four weeks prior to the Pfizer COVID-19 vaccine doses. Caller had his first dose of the covid-19 vaccine on 17Mar2021, caller stated that he had three big warts on his arm that he was going to have removed at the dermatologist, three days after receiving the vaccine the first wart was gone (Mar2021), the next day the second wart came off and the 3rd day the last wart was still anchored but was pulled off while working on the lawn mower, caller had his second dose (lot number: ER2613) on 07Apr2021. Consumer calling about the Pfizer COVID-19 vaccine shot, not to complain, he was actually happy they were gone. Caller clarified that he had viral infection warts on his right arm that were 3/8 of an inch to a half inch thick, and were always hanging on stuff. He said he went to a dermatologist for cancers and showed him those and they said for him to make an appointment to come back for insurance, and that they would probably have to take them off. He said after he got the first Pfizer COVID-19 vaccine dose, three days later one came off and then another started peeling up off his skin. He said that the third one was peeling up at the edges after the other one turned loose when he bumped it on the deck, so he pulled up on it and tore it off and it bled a little, but it is gone and hasn't come back, so he was proud of it. He says he didn't know if the warts coming off was because of vaccine, but when he took care of warts before he had them removed in the past or burned off. He said that he wanted to give Pfizer the information in case they could use the same medication to help with getting rid of warts without having them removed. He said he was proud the warts are gone, he didn't know if any others had this reaction to this medication, where their warts come off. He said other than this he just had a little soreness to his arm after injections in Mar2021. He said maybe they can make a cream or something to put on warts to make them come off. He said he didn't know if call handler ever experienced warts like this, but he had some burned off years ago, and they sell a wart remover that was smelly that you have to get on the wart that was an acid. No further details provided about the wart remover. He says maybe the could use the COVID vaccine to develop something with this pur-pose. For viral infection warts came off: Caller said that his warts he first had a while back, he knew they were on there the last time he went to see his dermatologist because he asked about them. He said he usually went to see his dermatologist between October and December at the end of every year, so those warts had been there about a year. He said that he noticed the first wart was gone within 3-4 days after his first Pfizer COVID-19 vaccine shot, and they were all gone within about 5-6 days, they were gone way before he went back for his second dose. He said he thought it was great they were gone. For injection site soreness: Caller said his arm soreness went away within 3-4 days, after the first dose it took 3 days, and after the second shot it took an extra day, so about 4 days. He said he did no treatment for the arm soreness. Caller says that the only thing that his viral warts coming off could be associated with was the Pfizer COVID-19 vaccine, and he was happy that they did come off. Description of complaint: Unexpected therapeutic benefit. No Investigation Assessment. The outcome of the event "a little soreness to his arm after injections/ injection site soreness/ arm soreness" was recovered on an unspecified date, of the other events was unknown. No follow-up attempts are needed. No further information is expected.

he pulled up on it and tore it off and it bled a little; had three big warts on his arm/the other one turned loose when he bumped it on the deck; the first wart was gone within 3-4 days after his first Pfizer COVID-19 vaccine shot, and they were all gone within about 5-6 days; the first wart was gone within 3-4 days after his first Pfizer COVID-19 vaccine shot, and they were all gone within about 5-6 days; injection site soreness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) and a physician reported that a 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 17Mar2021 (lot number: EM9809) at single dose for COVID-19 immunization. The relevant medical history included bypass surgery from 2019, stent placement from 2014, diabetic from 2001, ongoing viral infection wart (those warts had been there about a year) from an unspecified date. Concomitant medications were reported as none. The patient had three big warts on his arm that he was going to have removed at the dermatologist, three days after receiving the vaccine the first wart was gone, the next day the second wart came off and the 3rd day the last wart was still anchored but was pulled off while working on the lawn mower. The patient clarified that he had viral infection warts on his right arm that were 3/8 of an inch to a half inch thick and were always hanging on stuff. He said he went to a dermatologist for cancers and showed him those and they said for him to make an appointment to come back for insurance, and that they would probably have to take them off. He said after he got the first Pfizer COVID-19 vaccine dose, three days later one came off and then another started peeling up off his skin. He said that the third one was peeling up at the edges after the other one turned loose when he bumped it on the deck, so he pulled up on it and tore it off and it bled a little, but it was gone and hadn't come back, so he was proud of it. He said he didn't know if the warts coming off was because of vaccine, but when he took care of warts before he had them removed in the past or burned off. He said that he wanted to give Pfizer the information in case they could use the same medication to help with getting rid of warts without having them removed. He said he was proud the warts were gone, he didn't know if any others had this reaction to this medication, where their warts came off. He said other than this he just had a little soreness to his arm after both injections. He said maybe they could make a cream or something to put on warts to make them come off. He said he didn't know if call handler ever experienced warts like this, but he had some burned off years ago, and they sell a wart remover that is smelly that you have to get on the wart that is an acid. No further details provided about the wart remover. He said maybe the could use the COVID vaccine to develop something with this purpose. The patient said that his warts he first had a while back, he knew they were on there the last time he went to see his dermatologist because he asked about them. He said he usually went to see his dermatologist between October and December at the end of every year, so those warts had been there about a year. He said that he noticed the first wart was gone within 3-4 days after his first Pfizer COVID-19 vaccine shot, and they were all gone within about 5-6 days, they were gone way before he went back for his second dose. He said he thought it was great they were gone. He said his arm soreness went away within 3-4 days, after the first dose it took 3 days. He said he did no treatment for the arm soreness. The patient stated that the only thing that his viral warts coming off could be associated with was the Pfizer COVID-19 vaccine. The outcome of the event injection site soreness was recovered on an unspecified date, while other events were unknown. No follow-up attempts are needed. No further information is expected.

Feb 3, 2021. Five days after first vaccination, had severe dizziness upon awakening. Could barely stand up. Dizziness and lightheadedness has persisted on and off for almost two months. Felt much better for about 3 weeks and then it re-occurred and continues to this day (5/3/21). On the evening of 4/29/21, actually passed out and hit the floor incurring head laceration. Epley procedures have had no effect. Doctors have not found cause. Cardiologist has me starting on a monitor, but I'm sure that's not the issue. Dizziness comes and goes and is not always present. Have never experienced these symptoms before. No history of vestibular problems. Very distressing.

Reddness occurred recently, both arms; hard lump at the injection site; Severe right shoulder joint pain; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration, administered in left arm on 18Mar2021 at 10:15 (at the age of 76 years) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included Amlodipine/Valsartan 5/160mg Tab, Finasteride 5mg. Patient was not aware of allergies. The patient previously had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number:EN6205) via an unspecified route of administration, administered in right arm on an unspecified date in Feb2021 as single dose for COVID-19 immunisation and experienced swelling, redness, hard lump and a small blister. Patient was not diagnosed with COVID-19 prior the vaccination. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021, reddness occurred recently both arms, had a hard lump at the injection site and severe right shoulder joint pain. The patient did not receive treatment for events. Patient was not tested for COVID-19 since the vaccination. The outcome of the events was not recovered. No follow up attempts are needed. No further information is expected.

severe allergic reactions; Skin is starting to blister, like a poison ivy breakout, where the rash is located.; Elevated heart beat, feels flushed; Elevated heart beat, feels flushed; Itching; Broke out in a rash; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration in left arm on 20Apr2021 10:00 (Lot Number: EW0171) as single dose for covid-19 immunisation. Medical history included ongoing diabetic reported as 10 years ago. No other products. No investigation assessment. No prior vaccinations within 4 weeks. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. On 20Apr2021 after 10 am, patient experienced broke out in a rash, it improved when he took his medication, that he was given in the hospital, but then the rash came back as the medications wears off. About a half hour after the vaccine on 20Apr2021 10:30, patient had itching, when he took the medicine it helped the itching, but as the medicine wears off, the itching came back, with a vengeance. He went to the emergency room, yesterday for treatment. He was released and made contact with his family physician. He was taking Famotidine 20 mg by mouth once a day, and Benadryl every 25 mg, 2 pills, by mouth every 4 hours. He had some relief with these medications, but then started to feel the events as he got closer to taking his next dose. An hour or so after the initial shot on 20Apr2021 11:00 and then at the hospital, patient had elevated heartbeat, felt flushed. He seemed ok, but he wasn't sure, what his heart rate was, as he felt flushed once in a while. This morning on 21Apr2021, skin was starting to blister, like a poison ivy breakout, where the rash was located, it was about the same as when he took the medicine it helped, but as the medicine wears off, it came back. He had severe allergic reactions. Events required a visit to emergency room and physician office. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Swelling, reddness, hard lump and a small blister at point of injection in the right arm.; Swelling, reddness, hard lump and a small blister at point of injection in the right arm.; Swelling, reddness, hard lump and a small blister at point of injection in the right arm.; Swelling, reddness, hard lump and a small blister at point of injection in the right arm.; Severe right shoulder joint pain.; This is a spontaneous report from a contactable consumer, the patient. A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), dose 1 via an unspecified route of administration, administered in right arm on Feb2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was 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 and not tested for COVID-19 since vaccination. Patient was not allergies to medications, food, or other products. Concomitant medication included amlodipine, valsartan, and finasteride. In Feb2021, the patient experienced swelling, redness, hard lump, and a small blister at point of injection in the right arm, severe right shoulder joint pain. Treatment was not received for the adverse event. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown) via an unspecified route of administration on 19Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. on 19Mar2021, the patient experienced left kneecap went numb/started to come back, but just a little bit around the edge of the kneecap (hypoesthesia); on an unspecified date, the patient experienced knee pain/started getting pain, nothing severe/having pain even in bed when he repositioned/pain in the knee which made it to where it hurt to walk/walking I had pain and its making me limp this morning, knee pain/started getting pain, nothing severe/having pain even in bed when he repositioned/pain in the knee which made it to where it hurt to walk/walking I had pain and its making me limp this morning (gait disturbance), back pain, starting in the lower back and it kept getting worse, up my back, pain the size of a dime, like where your kidney is, lasting about 30 seconds, then it would wrap around to my appendix, bothered me all day (back pain), soreness to their arm where the injection was given. The clinical outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Extremely Swollen and extremely red left elbow; Extremely Swollen and extremely red left elbow; This is a spontaneous report from a non-contactable consumer. This 76-year-old male patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unknown route in the left arm, on 11Feb2021 12:00 (at the age of 76-year-old) at single dose for COVID-19 immunisation. No relevant medical history was provided. Relevant concomitant medications included methotrexate and calcium folinate (LEUCOVORINE). On 11Feb2021, the patient developed extremely swollen and extremely red left elbow. The events were assessed as non-serious. Both events required emergency room visit. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Chills for two days after the first vaccine. rash on right foot and right arm after the second vaccine which lasted several days and then dried up. At that point I had cold sweats and chills which started today about 10 AM. I texted Dr. who advised me that the rash should disappear in a few days. She was correct and a couple of days later texted that she had no concerns about the cold sweat and chills.

Severe throbbing headache, which lased until visit with doctor on 4/6/2021. Received Toradol injection, Thigh. Headache tapered off, then resumed one week later. Doctor ordered a prednisone taper, which ended the headache. Also, had a two week abdominal rash, beginning 2/27/2021 which was treated with Clobetasol Propionate .05% to resolve severe itching.

Herpes zoster right buttock with associated inguinal and penile pain.; Herpes zoster right buttock with associated inguinal and penile pain.; Herpes zoster right buttock with associated inguinal and penile pain.; This is a spontaneous report from a contactable Physician. A 76-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- El9263) via intramuscularly in right arm on 03Feb2021 at 08:30 AM as 2nd dose, single dose for COVID-19 immunization at Clinic. Medical history included crohns, allergic to some seafood, hypertension, hyper cholesterol. Concomitant medication included adalimumab (HUMIRA). Patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- El3246) via intramuscularly in right arm on 13Jan2021 at 08:45 AM as 1st dose, single dose for COVID-19 immunization. On 09Apr2021 at 14:00 PM, patient experienced herpes zoster right buttock with associated inguinal and penile pain. Therapeutic measures were taken as a result of the events included Ibuprofen, acetaminophen, lotions. Patient had not been covid tested post vaccination. The outcome of the events was not recovered. No follow-up attempts are possible . No further information is expected

Right after the vaccine, I had a slight ache at the injection site - that lasted a couple of days at the most. June 12th, I had a diarrhea. The surgeon who took care of my rectum - his office ordered a stool sample. I picked it up and took it back the same day - positive result for C Difficile - oral solution of Vancomycin - 2.5 ml every 6 hours for 10 days. I see the surgeon for the post op check on July 13th and maybe he'll re-test at that time.

Developed Covid Foot; feet were swollen and red and typically for Covid toes; Developed Covid Foot; feet were swollen and red and typically for Covid toes; This is a spontaneous report from a contactable physician. This physician reported for a 76-year-old male patient that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown, expiration date: not reported) via an unspecified route of administration on an unspecified date in Jun2021 (Exact date of the first vaccine unknown, it was about 7 days ago) as dose 1, single for COVID-19 immunisation (at the age of 76-year-old). The patient medical history and concomitant medications were not reported. The patient got the PFIZER COVID 19 VACCINE, and after about 24 hours on an unspecified date in Jun2021, developed pink-red feet with swelling, especially toes and especially great toes, very similar to Covid foot- toes that been seen with the actual disease, had improved significantly since then, now the question was he needed the second vaccine and were worried about the above reaction to the first dose of vaccine. The patient's feet were swollen and red and typically for Covid toes (start date: Jun2021). The patient had Covid feet (start date: Jun2021), and the toes were involved. It was reported that slowly it had improved significantly, but the patient was due for his second shot and he was worried about if he will have more issues with the second shot. The patient had significantly improved, about 90% improved and could get the information about the Covid vaccine later if needed. The patient wanted to get some help and information with how to proceed with the second vaccination. Reporter's seriousness for the events was medically significant. The outcome of both the events was resolving. Information on the lot/batch number has been requested.; Sender's Comments: Based on the plausible temporal relationship, the association between the events of swelling of feet and redness and the suspect product of BNT162B2 cannot be completely ruled out. 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.

itching rash; rash; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269, Expiration date was not provided), via an unspecified route of administration in left arm on 08Feb2021 at 09:40 AM (at the age of 76-year-old) as a dose 2, single for COVID-19 immunisation. The patient's medical history included (including any illness at time of vaccination) was Parkinson's. The family medical history relevant to AE(s) was reported as no. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3249, Expiration date: 31May2021), via an unspecified route of administration in left arm on 18Jan2021 (at the age of 76-year-old) as a dose 1, single for COVID-19 immunisation. No Prior vaccinations (within 4 weeks). History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. On 09Feb2021, at 02:30 Am, the Rash and itching started around early 2:30AM this morning. The rash woke him up this morning, it started with the itch. The reporter confirmed the rash and itching started 09Feb2021. It was reported that, the patient was called about the Pfizer Covid Vaccine. Stated that, he woke up this morning with a bad rash and bad itch on most of the body. The reporter clarified that, he already had his first dose, however this event occurred after the second dose. The rash and itching started around early 02:30 AM this morning. The rash woke him up this morning, it started with the itch, the reporter confirmed that, the rash and itching was started on 09Feb2021. He woke up this morning with a bad rash and bad itch on most of the body. He Received the vaccine 08Feb2021 morning. Stated that, he called because he would just like to get this itch over with. Stated that, he had no issues with vaccines in the past. He would like to know how to get rid of this. The caller was referred to his primary care doctor. The caller stated that, he will get treatment from his primary care physician. Stated that, the patient has not been in the emergency room and has not seen any doctor about this yet. The outcome of the events was not resolved. Follow-up attempts completed. No further information expected.

Adverse event #1: approximately 12 hrs after receiving the first dose while at home he became paralyzed and fell to the floor. This soon wore off and he was able to get up so medical assistance was not requested. This never happened before. Adverse event #2: approximately 6 weeks after the 2nd dose he noticed onset of swollen lips and large hives over the body. He was started on steroids/montelukast/cetirizine. 2 weeks after stopping the steroids/monteluklast he again broke out in intermittent hives. Pt has never had hives before. He continues to take ceterizine for this issue. He did not see an immunologist for this problem.

Itching; Scaliness of the skin, Similar to eczema; Scaliness of the skin, Similar to eczema; swelling of the right leg, Now also swelling in left leg.; dryness of skin; chills; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route, administered in Left Arm on 04Mar2021 at 13:30 (76-year-old at time of vaccination) as a Dose 1, single for Covid-19 immunization. The patient's medical history included diabetes mellitus, blood pressure. The patient received diabetic medication and blood pressure medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 infection. On an unknown date in 2021, the patient had experienced itching, scaliness of the skin, similar to eczema, swelling of the right leg, dryness of skin, chills. Now also swelling in left leg. The adverse event resulted the patient to visit Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19 infection. The patient received antibiotics, benadryl, lotion for skin as treatment medications for the resulted events. The outcome of the events was not recovered. Information on the batch/lot number has been requested.

vomited; nausea/ felt sick to his stomach; felt woozy; didn't feel well; right deltoid soreness; This is a spontaneous report from a contactable physician (patient). A 77-years-old male patient received the first dose of BNT162B2 (Lot: EH9899), via an unspecified route of administration in deltoid right, on 24Dec2020 11:30 at single dose for COVID -19 immunization. Medical history included pulmonary embolism half a dozen years ago. He has had no problems with Deep Vein Thrombosis or pulmonary emboli since then, since half a dozen years. He has had a battery of lab tests 2 months ago, his blood glucose was high, it was 106 mg. The potassium was ok. He has had no issues with vaccines in the past. He had an antibody test last Jul2020 because he had bacterial lower urinary tract prostate infection. Concomitant medication included rivaroxaban (XARELTO) at 10 mg a day and cefalexin sodium (CEPHALEXIN) at 500 mg three times a day, well approximately 3, sometimes he forget a dose. The physician reported possible side effects of Covid vaccine. The physician received the vaccine on 24Dec2020 at 11:30 in the late morning and felt fine. He woke up on 25Dec2020 and at 2:30AM he was sick to his stomach and vomited and didn't feel well the rest of the day. Since then he had been okay, he had occasional nausea and vomiting. He clarified that on 24Dec2020, in the late evening, his appetite which was usual, was robust. Then on 25Dec2020 at 2:30 in the morning he vomited, and had no trouble since then. From what he read, nausea and vomiting are observed following the injection. On 24Dec2020 just before bed, he had a light supper, his appetite was robust, then unexpectedly he woke up sick to his stomach and went back to bed on 25Dec2020. He clarified that he had not vomited since the one episode on 25Dec2020. He also added that he has not been nauseous since then. Caller also added that he felt a little woozy on Holiday 25Dec2020, it only lasted up until the evening of 25Dec2020. He had the 1 episode vomiting on 25Dec2020 and felt woozy until late evening of 25Dec2020. His right deltoid where he received the vaccine was a little bit sore on 24Dec2020, and he was still having a little bit of soreness, it is slight, not very tender, he is unable to do usual morning exercises with out noticing the discomfort, the exercise he is doing is chin ups, the soreness is not intense and it never was. The lab test in 2020 included Height: under 5 feet 5 inches. Weight: about 165lbs or 167lbs. He had no positive test for COVID prior to the vaccine. All the tests were negative. The 1st one was nasopharyngeal, and all the next ones after were nasal swabs. He thought they are all reverse transcriptase tests. The last time he had a COVID test they did a nasal swab, it was this morning, and before that was last Monday or Tuesday, but he thought more so Monday. He had one PCR test. The outcome of the events vomited, nausea and felt woozy was recovered on 25Dec2020. The outcome of the event right deltoid soreness was recovering. The outcome of the other event was unknown. The 2nd dose for Covid vaccine was schedule for 14Jan2021.

THE NIGHT OF VACCINATION DAY, RESIDENT BEGAN C/O SEVERE PAIN IN THE INJECTION ARM. THE DAY AFTER THE VACCINE, HE BEGAN HAVING MOOD ISSUES, VERBAL AGGRESSION/OUTBURSTS (ABNORMAL FOR THIS RESIDENT), DIZZINESS AND A SEVERE HEADACHE HE RATED AT 10/10 PER PAIN SCALE THAT DID NOT RESOLVE WITH SEVERAL DOSES OF PAIN MEDS.

THE NIGHT OF VACC DAY, C/O SEVERE INJ ARM PAIN. THE FOLLOWING DAY, HE BEGAN DISPLAYING VERBAL AGGRESSION AND OUTBURST TOWARDS STAFF WHICH IS OUT OF NORMAL FOR HIM, INCREASED DIFF REMEMBERING SHORT TERM, C/O DIZZINESS AND SEVERE HEADACHE RATED 10/10 ON PAIN SCALE NOT RELIEVED WITH SEVERAL DOSES OF PAIN MEDS AND RANDOM DIZZINESS

Very sore upper right arm at site of innoculation. By 01.25 pain had resolved. 01.25.2021, 12 Noon, Very sore jaw, right side.

sore arm/soreness in the arm; a little swelling, slight swelling/there was a little swelling where it was injected; This is a spontaneous report from a contactable consumer (patient). This reporter reported similar events for two patients. This is 1st of 2 reports. A 77-year-old male patient received first dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 11Jan2021 12:00 at single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus. Family Medical History was None. The patient previously had pneumonia shot that he had a pretty bad reaction to one time. It was hard to explain, he had sloughing to the skin on the left arm. Under the left arm was hanging down about 3-4 inches. There was some fluid of some sort. He went to the clinic and they gave him something and it went away and he was told not to get another one. It was about 8-9 years ago. The patient's concomitant medications were not reported. The patient experienced sore arm and a little swelling, slight swelling on 11Jan2021. The patient noticed the soreness in the arm about 2-3 hours after getting the shot, but it was getting better, but there was a little swelling where it was injected. There was slight swelling, but not much. The outcome of event "sore arm/soreness in the arm" was unknown; of event "a little swelling, slight swelling/there was a little swelling where it was injected" was not recovered. Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026404 same reporter/product, different patient.

No reaction originally; but 10 days after receiving the PFIZER-BioNTech COVID 19 Vaccine EUA I had severe pain in my left (vaccine site) upper arm muscle and shoulder joint; and was unable to lift my arm up away from my left hip. I have been experiencing these severe symptoms since the 10th day after receiving the COVID Vaccine (now the 12th dasys after the vaccine)

It's really itchy on my back; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (Patient) A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 31Dec2020 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. Patient informed that since an unspecified date it was really itchy on my back, it was no terrible hype but really for the last 3 days (as reported). Patient also mentioned that she should get her booster this coming week (as such). At the time of the reporting event outcome was unknown. The information on the lot/batch number has been requested.

intense itching/ itching on his hips and on his back; gets red whenever he scratches it; after the injection his arm got a little sore; Feels like it is hot; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246, expiry: 30Apr2021) intramuscularly into the left arm on 06Jan2021 at a single dose for covid-19 immunisation. Medical history included nerve damage, brain damage, disability from 1997, anxiety, major severe depression, occupational exposure to heavy metal uranium, chronic obstructive pulmonary disease (COPD), early stage emphysema and diabetes. Concomitant medication includes unspecified medications for brain damage, anxiety and major severe depression. It was reported that after the injection, his arm got a little sore on 06Jan2021. On 13Jan2021, patient experienced intense itching; further reported as itching on his hips and on his back which gets red whenever he scratches it. It was also reported that the more he would scratch it, the more intense the itching would get. On an unspecified date in Jan2021, the patient also feels like it is hot. The patient applied EUCERIN cream and CORTISONE 10 for the events "intense itching/ itching on his hips and on his back" and "gets red whenever he scratches it". The patient was scheduled for his second dose on 27Jan2021. Outcome of event "intense itching/ itching on his hips and on his back" was not recovered while for the events "after the injection, his arm got a little sore", "gets red whenever he scratches it" and "feels like it is hot" was unknown.

Thrombocytopenia, SkinRash, Rash & ElevatedBunSCr Narrative: Petichial rash. Patient had IV contrast dye 1/19 no reaction. Patient on Apixiban for a. fib.

Rash all over my body started about 14 days after the injection. As of 2/6/2021 the rash is still there but is slowly going away.

Very Sore upper left arm with deep bruises covering significant part of upper left arm below injection site.

Headache; Horizontal red line of swelling at the injection site; Horizontal red line of swelling at the injection site; Nausea; Circular rash on the shoulder; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 20Jan2021 (12:30) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization. Medical history included high blood pressure (HBP); atrial fibrillation (atrial fib.); sleep apnea; heart disease; contrast dye allergy; and mold allergy. Concomitant medications included losartan, carvedilol (COREG) and piroxicam (MAXIDENE). On 22Jan2021 (08:00), the patient had headache; horizonal red line of swelling at the injection site; nausea; and circular rash on the shoulder. The patient did not receive any treatment for all the reported events. The outcome of the events, 'headache', 'horizonal red line of swelling at the injection site', 'nausea' and 'circular rash on the shoulder', was not recovered. The patient was not diagnosed with COVID-19 prior to the vaccination, and was not tested post-vaccination.

Severe pain in upper left arm muscle (vaccine site); Severe pain in upper left arm muscle (vaccine site)/ also in my left shoulder joint; Severe pain in upper left arm muscle (vaccine site)/ also in my left shoulder joint/ unable to lift my left arm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 13Jan2021 12:45 at single dose for COVID-19 immunization. Medical history included high blood pressure and cholesterol from an unknown date and unknown if ongoing. Concomitant medication included medication for high blood pressure and cholesterol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that initially, there was no adverse reaction, but 10 days later on 24Jan2021 07:00 AM, the patient stated, "I experienced severe pain in upper left arm muscle (vaccine site) and also in my left shoulder joint. Also unable to lift my left arm. The lower arm and fingers function normally. These symptoms continue through today 12 days after the vaccine ". The outcome of the events was not recovered. No treatment was given to the patient for the events. The events were considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and were not a congenital anomaly/birth defect. Information on the lot/batch number has been requested.

moderate pain at injection site rt arm. lots of body/ joint pain. chills. headache. no fever . lasting 24 hrs

Pfizer-BioNTech COVID-19 Vaccine EUA Six days after second dose developed large red itchy patch on arm near injection site. Approximately 2 and a half by 4 inches in size

At the time of injection, injection site immediately began to swell to approximately 2 cm diameter, No stridor, wheezing, or other sx. Blood Pressure 115/85, HR 60, SaO2 99%, Temp 97.7 F po. No progression of edema or any symptoms. Evalluated by rapid response team, patient opted to not go to the ER. Released after observation.

Initially sore arm at injection site, on 2/1/21 continues with drowsiness, sore throat, stuffy nose, productive cough with yellow phlegm, congestion

Fall 2/4 hospital admission 2/7/21 with death on 2/8/2021. Patient continued to decline on Bipap he was a DNR/DNI and family decided on comfort measures and he expired 2/8/2021.

Hypothermia/A temperature of 93.7 orally/temperature was 92.7/went down to 93.2 degrees; Chills; The arm he received the injection in was tender however progressed to mild to moderately painful/arm was suddenly painful; Shaking; Injection site tenderness; This is a spontaneous report from a contactable physician (patient). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9262, expiry: unknown), via an unspecified route of administration in the left arm on 26Jan2021 15:30 at a single dose for protection from the virus at the Physician Office. Medical history included type 2 diabetes mellitus from 2011 and ongoing. The patient also thought he had a Covid respiratory infection in Feb2020. He had a prolonged moderate to severe respiratory infection. He thought at first that he had the flu, but he had a flu shot. He thinks he had Covid. He had antibody studies in May2020 (last spring) that were negative. The patient has no concomitant medications. The patient previously had influenza vaccine (flu shot). The patient reported hypothermia after getting the first dose of the Pfizer Covid 19 vaccine. On the same day of vaccination (26Jan2021), he had injection site tenderness. The next day, (27Jan2021), his arm was suddenly painful; he began to have chills 29 hours after receiving the vaccine (27Jan2021) and was shaking. He also had a temperature of 93.7 orally, confirmed with two different digital thermometers. He took his temperature with a new electronic thermometer that he purchased at a pharmacy. His temperature was 92.7 on 27Jan2021. He repeated it with another electronic thermometer. The first evening (27Jan2021), his temperature went to 96.5 to 98 degrees. Then it went down to 93.2 degrees. He covered up with blankets and his temperature increased and the chills stopped. He stated that this was hypothermia. He had low temperatures the following day (28Jan2021) as well, his temperature was 93-94 degrees. His temperature was 93.7 degrees. Other times he checked his temperature and it was 96.5 degrees. When his temperature was low the first time, it only lasted for about three hours. The second time it happened he went to bed and covered up. It lasted for an hour or two. He noticed it again two days ago. The patient also stated the arm he received the injection in was tender however progressed to mild to moderately painful when he experienced the chills and low temperatures. The arm tenderness after getting the vaccine was very mild. He noticed it when he rolled over on his arm. He took some Tylenol for it. His son is an internist. He said the hypothermia was medically significant. His son also said hypothermia is equivalent to a fever in the elderly. The patient wanted to know if there have been any reports of hypothermia after the administration of the vaccine. He has concerns about this occurring after the second dose. He is scheduled to receive the second dose on 15Feb2021 or 16Feb2021. The outcome of the event hypothermia was recovered on 30Jan2021 and pain in arm recovered on 27Jan2021. The outcome of the other events was unknown. The events hypothermia, arm pain and injections site tenderness were assessed as related to BNT16B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported hypothermia and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

2-3 weeks after COVID vaccination, patient presented to hospital with anemia and thrombocytopenia and intracranial hemorrhage. L axillary mass (same side as Pfizer vaccine admin site) found on exam. Bone marrow biopsy demonstrated Burkitt's Lymphoma. He is undergoing treatment at hospital

Pfizer COVID vaccine first shot Jan. 16 2021 SECOND SHOT 2/6/21 first shot developed rash on left upper leg and blisters on lt foot. was almost gone then after second shot sunday morning woke up with rash both upper legs, bach and many blisters on feet, has been same but more rash on both legs and body , many blisters on both feet could hardly walk sunday and monday after second shot

I've had shingles around the back of my neck for three days so far, diagnosed by by Primary care. Treatment: Prescriptions for Valcyclovir and Gabapentin. As this came out of nowhere just two weeks after my first Covid shot andI have seen reports of a few similar cases around the world, I thought that CDCshould at least have this information as a possible side effect , worth some later research.

1. Pain at site of injection started about 6 hours post second vaccine injection (7-8 on a 0-10 scale) that lasted for almost 48 hours, most intense during the day following injection. No treatment for that. 2. Significant fatigue on the morning 14 hours following the injection (could have started during the night) . Difficult to maintain balance. Just rested the whole day. Unable to exercise on stationary bike. 3. Low grade fever (just under 99 F; base line for me has been 97.6 F) in the evening following injection, gone next morning. No treatment.

itched everywhere ears, scalp legs and arms.; headache; tired; itchy nose; This is a spontaneous report from a contactable consumer (patient) A male patient of an unspecified age received BNT162B2 (Solution for injection, Lot/Batch number was not reported) via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient received the first vaccine on 21Jan2021. He had a headache, tired and itchy nose. He took a benadryl and it went away. On 25Jan2021 that he itched everywhere ears, scalp legs and arms. The symptoms went away 30 minutes after Benadryl. The patient was not getting any better and maybe a little worse. The outcome of the events was recovered on an unspecified date of 2021.

Sudden development of rash all over body, flushed face, tired, weak, headache, temperature 97.8, blood pressure 108 over65, pulse 75. Sat down, took prednisone 20 mg and benedryl. Symptoms lasted for a couple of hours. Rash took several hours to reduce. Continued prednisone overnight. Next morning seemed very improved. IT TRULY SEEMED LIKE AN ANAPHALXIS REACTION. Waiting for Health Dept. nurse manager to call back. As noted, this Anaphalixis occurred 72 hours after the vaccination.

Rash- left calf, ankle to knee; Received BNT162B2 with medical history of Psoriatic arthritis; Received BNT162B2 with medical history of Psoriatic arthritis; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EJ1686), via an unspecified route of administration in the left arm on 20Jan2021 10:15 at SINGLE DOSE for Covid-19 immunisation. Medical history included type 2 Diabetic, Psoriatic arthritis and had heart disorder, allergic to sulfa drugs. He did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included warfarin, sitagliptin phosphate, aspirin (acetylsalicylic acid). The patient experienced rash in the left calf, ankle to knee on 22Jan2021 08:00 (no treatment). The outcome of event was not recovered.

2 days after 2nd dose of Pfizer vaccine pt developed stuffy nose, SOB, but no cough, fever, or chills, then developed an itchy rash on Rt foot that spread to arms and legs resulting in a peticheal rash/lesions on dorsum of feet, shins, thigh, mid abdomen, medial arm and back. Dermatology consult felt due to allergic purpura, and vasculitis possible but less likely. Platlet count in the normal range.

Patient described the event as "severe anaphylaxis" that included redness all over the body and a rash on the face, with a strange feeling in the esophagus but no trouble breathing. The patient self-medicated with prednisone and did not seek medical care. Symptoms resolved later the same day they appeared. The patient indicated he had an appointment unrelated to this event scheduled with his primary care physician on March 3, 2021, and was advised to discuss the reaction with the physician at this appointment.

About 24 hours after the injection, I had extreme fatigue and difficulty getting out of bed. along with body aches in both arms and a seizure like blank stare and couldn't move my arms and legs for a short time. Briefly I had shakes in both arms but no fever, chills, or headache. By the next morning the injection arm (left) was achy with no other prominent symptoms.

Dizziness and nausea, fever peaking at 101.4 deg, chills lasted for 2 days. Severe muscle aches, strong joint pain, persistent tiredness, bowel irritation lasted for more than 3 weeks so far. Examined by doctor but no treatment prescribed. Rash in right arm was visible on fourth day, below shoulder where second shot was received. Severe pain in left shoulder on third day, where first vaccine shot was received 3 weeks before second shot. Most symptoms are improved at this time, but still some tiredness and muscle and joint pain.

Ten days after 2nd Pfizer vaccine developed severe pruritus and re/activation of Zoster pain.Bx revealed hypersensitivity reaction with eos. Treated with topical steroids and low dose prednisone .Resolved by 75% by March 6

Following Dose 1, Right Arm became sore at injection site for 4 days, at which time Right armpit became very tender touch and was swollen about size of silver dollar, approx. 1/2 inch thick. Soreness at injection site subsided over the next 17 days, but tenderness in armpit only diminished slightly. Following Dose 2, Right Arm was once again sore at injection site for about 4 days, but tenderness to the right armpit became more pronounced, with swelling increasing to the size of a hockey puck. Size of swelling was easily visible to the eye. Armpit became more tender to the touch, and has diminished only slightly in size,, as of this reporting. Mass remains soft to the feel, but easily defined in size and location. I have taken OTC pain killers to help with the discomfort. Will continue to monitor its progress, unless notified otherwise. Do not anticipate seeing my physician at this point. Have consulted the Web, and have noted that this is a lesser side effect of this vaccine, if swelling remains localized to the injection site. Thought I should report this side effect only because of the size of the swelling that occured.

hives on the injected arm/ diagnosed by his physician as shingles; experienced pain and itching near the injection site; experienced pain and itching near the injection site; red splotches under his arm and on his chest; chest that were itching; This is a spontaneous report from a contactable consumer (patient).A 77-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 29Jan2021 (vaccine location: right arm) at single dose for COVID-19 immunisation. The patient's medical history was included Prediabetes. The concomitant medications were reported as metformin at 1000mg by mouth for Prediabetes and blood pressure medication. Patient got his first shot on 29Jan2021, about 3-4 days later (in Feb2021) it started hurting/ pain and itching near the injection site, he found red splotches under his arm and on his chest and chest that were itching. Later, patient developed hives on the injected arm, he was able to get to the doctor today to see him, doctor diagnosed him with shingles and gave him some medicine. Patient wanted to know if it is safe to proceed with the next dose since it was scheduled 20Feb2021. The outcome of red splotches on arm and chest that were itching was recovering. The outcome of other events was unknown. Information on the batch/Lot number has been requested.

3-3-21 unable to open jaw, sweating (sweating resolved). 3-4-21 swelling to chin area with redness. took tylenol reports it helped him. asked if he had any fever, wife reports "no". called PCP spoke with his nurse, pending further instruction from PCP and or nurse. Wife called back states her Husband has abscess tooth, so feels maybe related to that. Wife states he was given Amoxicillin yesterday at MD office. She states he is feeling better today, eating slowly.

On 2/25 he started having severe itching all over for the knees up. On Friday he had facial swelling and swelling with both hands and puffy fingers. Between his fingers he became very red and his face was red.

1st vaccination Friday. I was fine on Friday. Saturday woke with sore throat, neck, mucus, sore muscles and weak. By mid-afternoon had to go to bed and slept for hours. Got up at 9PM and went back to bed at 11PM. Sunday was better, but this AM (Monday) awakened with itchy skin, pins and needles on hands and feet (gone now) and total exhaustion. Had difficulty breathing (better now), can barely lift arms and had to miss work and went back to bed. I am reporting this because I am scheduled for a 2nd shot on the 26th and not certain it's a good idea.

got a sore arm and it was somewhat inflamed at the site of the injection; got a sore arm and it was somewhat inflamed at the site of the injection; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL9269), via an unspecified route of administration on the arm on 06Feb2021 (at the age of 77years) at single dose for COVID-19 immunization. Medical history included cholesterol. Concomitant medication included atorvastatin (LIPITOR) for cholesterol (besides that, everything was fine and the range was normal because he was taking the pills). The patient received his vaccination yesterday (06Feb2021) at a hospital. On 07Feb2021, the patient got a sore arm and it was somewhat inflamed at the site of the injection. The patient have taken paracetamol (TYLENOL). The patient have checked the website and various other aspects. They said number 1, having a reaction like it was a good thing because it indicates his immune system was functioning as it should because of the foreign particle, which was encouraging and then it mentioned one should, if there was ice available put ice on the swelling to like cool down the inflammation and if one did not have the ice, one should use a cold wash support. The patient asked if that knowledge was a possible remedy. The outcome of the events was unknown.

After Does 1, I broke out into hives, I was given prednisone and the swelling and itching did go down. After dose 2, The hives returned and I developed plaque psoriasis all over my body in perhaps 20 locations. I was given prednisone again, the itching stopped but The psoriasis remains and is getting worse. As a note, I have had psoriasis for most of my life on my hands and feet, but after this experience I have psoriasis all over my body.

low temperature (96.5); Chills; slight tremors; soreness at injection site; This is a spontaneous report from a non-contactable consumer (patient). A 77-years-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration on 10Feb2021 08:15 at age of 77-years-old at arm left at single dose for COVID-19 immunisation. Medical history included bladder cancer, high blood pressure and no known allergies. Concomitant medication included allopurinol, amlodipine, valsartan, indapamide, atorvastatin (LIPITOR), pregabalin (LYRICA), metformin hydrochloride (MEDFORMIN), metoprolol succinate (TOPROL) and vitamin supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the 1st dose of BNT162B2 on 18Jan2021 at age of 77-years-old for COVID-19 immunisation. The patient experienced chills, low temperature (96.5) and slight tremors, soreness at injection site on 10Feb2021 06:00 (as reported). No treatment was received for the adverse events. The events outcome was recovered on an unspecified date in Feb2021. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.

Red spot at injection site that lasted for days until second injection, nurse looked at it and said it looked ok. Red spot started to bleed and went to doctor, listed above, and received antibiotic to take 10 days and tube is ointment for spot.

Almost immediately felt swelling at the injection site, which I felt as being normal. Next day when I woke up felt a slight headache , abnormal vision issues that included sparkles, blurred vision and a general tiredness. Did not feel refreshed as I normally do when I wake up in the morning. As the day went on sparkles and vision issues remained and headache got worse. Went to bed earlier than normal and next day when woke up the symptoms got worse, I felt like I had a migraine. Vision issues persisted. Laid down around 11AM and took a nap and when I woke up I noticed a blotch in my left eye reminiscent of the shape of a fish (looked like a shark) and it had different colors. Bright yellow and black almost kind of an iridescent green and orange. The shape was still just the colors were different. I panicked and called the optometrist and explained what happened. They wanted to see me right away. I was able to be seen in the afternoon. They looked at it, did two tests and came with the diagnosis of a branch retinal artery occlusion. I visited my neuro- ophthalmologist on 01/28 and he confirmed the diagnosis had previously given. He then ordered fedrate and a couple of other tests. They also did a visual acuity in the left eye (20/30) and color vision (8/8 normal) and color plates and intraocular pressure (16 OS)

Itchy pink splotches head to toe became noticeable irritation during the second night after the vaccination, confirmed in the morning. Went to urgent care the following Monday afternoon. Consultation verified the symptoms. Doctor concluded that the timing indicated a reaction to the vaccination rather than a reaction to the penicillin that I had been taking several days for a UTI. I have never had any problems with any of the medications or supplements that I take regularly. The doctor prescribed Prednisone, Cetirizine, and Tagamet, which I am currently taking. There has not yet been any reduction in my extensive symptoms.

pt stated he had a head ache about 15 minutes after getting the vax but subsided quickly. When he woke up the next morning he had tightness in his chest that last a while and then went away. A couple of days later he had a dizzy spell which would come and go. This lasted about 3 days. He had another episode of tightness in his chest. On 3/7/2021 he developed a red rash on his chest that had a hive in the middle of it that was itchy. He started getting itchy spots on the top of his hands, fore arms, top of his ears, and the top of his head. At this time he only has slight rash on his chest and shoulders that are not itching.

Progressive Left arm pain/shoulder soreness that began 5 days prior to hospital presentation. Seen in ambulatory clinic 7 days prior to presentation, given ibuprofen and percocet without relief. New swelling and erythema brought pt to hospital. Around time of vaccination, the pt was using triamcinolone for left forearm rash (described as small, more-spotty and resolved quickly). MRI revealed an abscess (10 x 6.8 x 1 cm) deep to the deltoid muscle and along the lateral aspect of the left proximal humerus. He also has another abscess within the posterior deltoid muscle (3.1 x 2.1 x 2.8 cm). There is surrounding myositis, fasciitis and cellulitis.

About 1 week after 2nd shot, fairly large rash area appeared on inside of left elbow area. Still there after 2 1/2 weeks.

mental fog/bit of fog; foggy; Nausea; very sleepy; tired; Injection site pain/pain to the injection site; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in the left arm on 19Feb2021 08:40 at a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (Afib) about 10 years ago (2011). Concomitant medication included unspecified medications including blood thinner and Afib medications. The patient takes 6 medications: some of those medications for 40 years, some for a bit less. There were a couple more added for his heart because 10 years ago he had a case of Afib and the doctor who has now retired took him from 3 meds to 6; and has had no issues for the last 10 years. The patient had his first dose on 19Feb2021 at a clinic and was due/scheduled for his second on 12Mar2021. The patient had severe reactions to the first one so he wanted to know if he should accelerate second shot or stay within three weeks. His reaction was for the first two weeks, he had severe nausea, etcetera, which was getting better that week. He gives 20-minute presentations each morning and the participants in the presentation were nice about it but they say that the patient has fog and thought he should see if he should go in sooner as they were worried about him. His only symptoms remaining after two weeks of severe reactions was that he was very sleepy. All that was left was being tired and mentally in a bit of fog (also reported as mental fog). The patient only had pain to the injection site for a day and was not an issue, then it didn't take long for him to start getting extremely tired and have nausea. He says all he knows was that from the sheet listing severe reactions, he had every one during the first couple weeks (unspecified), though he never had a fever. He says this week he felt better and he was starting to eat, this was not normal for him to be tired all the time, but at least he was not sick. He says he didn't treat the pain or nausea, because he was healthy as a horse, and has no problems with a vaccine, shots don't bother him other than having soreness the first day. The patient was just foggy and tired. The patient was recovering from nausea. The patient recovered from injection site pain on 20Feb2021. The patient has not recovered from mental fog/bit of fog and tired. The outcome of the remaining events was unknown. Information on the lot/batch number has been requested.

72 hrs. after dose #1 had a severe anaphalaxis reaction.; red rash; pressure dropped to 102/65/75 pulse; Tired; light-headed; weak; This is a spontaneous report from a contactable consumer (patient) and another consumer (receptionist). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Feb2021 15:00 (Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation. Medical history was not reported. The patient did not have COVID prior vaccination. Concomitant medication(s) included simvastatin, losartan, finasteride and tamsulosin. The patient previously took codeine and experienced allergies. On 28Feb2021 15:00, 72 hrs. after dose #1, the patient had a severe anaphalaxis reaction. His whole body turned into a red rash, temp was 97.8, pressure dropped to 102/65/75 pulse. Tired, light-headed, weak. Immediately took Prednisone (20 mg)and benedryl. Was going to call 911, but symptoms subsided slowly. The patient did not test COVID post vaccination. The outcome was recovered.

Client states he developed blisters on 04/03-/21 starting at lower right buttocks radiating to the right leg onto his penis. Client visited Dr and was diagnosed with shingles. Dr prescribed valtrex and prednisone. Client reports symptoms improving.

Pain/pain in the right arm/most severe pain patient had ever had; patient would say 30 times worse than any fly shot for example; Pain into shoulder area, deltoid muscle nearly totally paralyzed; pain down arm to elbow; This is a spontaneous report from a contactable Physician (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263; expiration date: unknown), via an unspecified route of administration on right arm on 21Jan2021 at 14:30 (02:30 PM) at the age of 77 years old at a single dose for COVID-19 immunisation. Medical history included S/P CABG in 2015, S/P ruptured appdx in 2007. He was asymptomatic, major operations (laparotomy and open-heart surgery) and a retired surgeon. He was still solo skydiving from 14,000 feet with no problems. Allergies were none. Concomitant medications included losartan, metoprolol, vit D (ergocalciferol), aspirin (acetylsalicylic acid) and lipitor (atorvaostatin). It was reported that no problems at all until approximately 10 hours post injection. The most severe pain patient had ever had; patient would say 30 times worse than any fly shot for example. Pain into shoulder area, deltoid muscle nearly totally paralyzed, pain down arm to elbow. Got one hour of sleep that night. Amazingly, at about 11 a.m. the next morning while still in severe pain (R arm) all symptoms immediately disappeared. Like a switch was thrown. Two major operations in patient life (laparotomy and open heart surgery) and patient also a retired surgeon. Patient was not exaggerating the degree of this pain in the right arm. Have felt great ever since and would get Shot # 2 tomorrow. The events onset date reported as 21Jan2021 11:30 PM. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No treatment received for the events. The patient recovered from all the events on an unspecified date in 2021.; Sender's Comments: Based on temporal association and known vaccine safety profile, the reported events are assessed as related to BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

On 04/08/2021 red splotchy areas on left and right arms just above the inside crook of the elbows and on both upper legs on the inside areas close to the groin. On 04/09/2021 more red splotchy areas on lower back, more areas on the legs and arms. Did not c/o of itching on 4/8 but did on 4/9 Temp not taken on 04/08/2021 but skin was cool. Temp taken 04/09/2021 and was 98.6 Doctor offices closed so no one was called.

This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of BNT162B2 (solution for injection) via an unspecified route of administration, in left arm on 09Feb2021 (Batch/Lot Number: EN5318; Expiration Date: 31May2021) at single dose for covid-19 immunization. Medical history included diabetes mellitus from 2004. There were no concomitant medications. The patient said yesterday morning he had whelps on his left and right legs with some swelling, also whelps to upper left arm and left elbow. He clarified that he had slight swelling to his legs, with little whelps or hives to his legs and calves. He had done no treatment, though last night before bed he put alcohol, clarified to being Swans 70% rubbing alcohol with a swab where it was itching, it seems to be getting better, it doesn't itch as much. Swans 70% rubbing alcohol LOT: 0501407, EXP Sep2023, UPC: Number. Outcome of itching was recovering, and outcome of other events was unknown.

weight loss; no appetite; breathing is shallow; low oxygen 89%; muscle aches; imbalanced; can't sleep; blood pressure down/128/68/and 132/76; weird dreams; minimal injection site pain; This is a spontaneous report from a contactable pharmacist. A 77-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection) via an unspecified route of administration, administered in Arm Right on 13Feb2021 17:15 (Batch/Lot Number: EL9209) as single dose for covid-19 immunisation. patient medical history about 20 years ago for a torn ACL and also general surgery. Concomitant medication(s) included levothyroxine taken 100 ug once a day for an unspecified indication from 2018 and ongoing; atorvastatin (LIPITOR) oral 100 mg, once a day taken for blood cholesterol increased from an unspecified start date and ongoing and vitamins Cs and Bs as supplements. The patient experienced minimal injection site pain on 14Feb2021, can't sleep, blood pressure down 128/68/and 132/76, no appetite, breathing is shallow, muscle aches, imbalanced, low oxygen 89% and weird dreams on 26Mar2021. weight loss on 27Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021, body temperature: 98.3 on 26Mar2021, oxygen saturation: 89 % on 26Mar2021, blood pressure measurement: 132/76 on 28Mar2021, body temperature: 98.3 on 28Mar2021 and oxygen saturation: 95-96 % on 28Mar2021, body temperature: 100.8 on an unspecified date and oxygen saturation: 96 % on 29Mar2021. The report considered as a serious. The outcome of the events can't sleep , weight loss, no appetite, breathing is shallow, muscle aches, imbalanced and weird dreams was reported as not recovered, minimal injection site pain was reported as recovered as 15Feb2021 . blood pressure down/128/68/and 132/76 and low oxygen 89% was reported as recovering,; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be completely excluded. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

in hot and sweaty; thought a truck hit him and he must've over done it. He said that as the day went one he felt worse.; headaches; he felt so bad; He has not moved around much at all; watery eyes; sneezing; abdominal pain; gas; tender if you touched directly at the injection site; in hot and sweaty; weight loss; Mucousy Mouth; Hoarse voice; low oxygen; weird dreams; can't sleep; blood pressure down; no appetite; breathing is shallow; muscle aches; imbalanced; Weakness; Fever; minimal injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 77-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9209, Expiration date was not reported), via an unspecified route of administration on 06Mar2021 17:15 as single dose for covid-19 immunisation. Medical history included ongoing high cholesterol. Concomitant medication included levothyroxine, tablet via oral from unknown date 2018 at 100 uCi, once a day for chemical thyroid condition, atorvastatin calcium (LIPITOR, tablet) via oral 10 mg once a day for blood cholesterol increased. Historical vaccine included first dose of BNT162B2 on 13Feb2021 for covid-19 immunisation. The patient experienced mucousy mouth, hoarse voice, weight loss on 27Mar2021, low oxygen, weird dreams, can't sleep, blood pressure down, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, Fever 26Mar2021, patient hot and sweaty, in hot and sweaty, thought a truck hit him and he must've over done it. He said that as the day went one, he felt worse, headaches, he felt so bad, He has not moved around much at all, watery eyes, sneezing, abdominal pain, gas and tender if you touched directly at the injection site on an unspecified date, minimal injection site pain on 14Feb2021. As per the reporter seriousness criteria reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021 and 132/76 on 28Mar2021, temperature: 100.8 on an unspecified date and 98.3 on 26Mar2021 and 98.3 on 28Mar2021, Pulse oximetry: 89 % on 26Mar2021, 95-96 % and 96 % on 29Mar2021. The outcome of the event mucousy mouth, hoarse voice, weird dreams, can't sleep, weight loss, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, fever was not recovered, minimal injection site pain was recovered on 15Feb2021, blood pressure down recovering and unknown for other events.

Substantial flu-like symptoms. Chills. Mild ache near injetion site next morning for less than hour. Cured with 1000mg Acetaminophen several hours later.

psoriasis its been the worst ever in his 40 years; started itching; It had welts; red marks; He sees his leg is all red, almost looks like shingles.; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received the second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 10Feb2021 'about 3PM' (Batch/Lot Number: EM9810; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunization. Facility in which the vaccine was administered was a hospital Medical history included psoriasis (In the summer, his psoriasis is greater and in the winter, his skin is more dry) . Patients family history (patients daughter) includes coeliac disease and psoriasis. The patient's concomitant medications was reported as 'taking regular medication for years' (details not provided). Historical Vaccine Dose 1 received 22Jan2021 between 1100-1300, (Lot: EL3246 Expiration Date: 30Apr2021, Route of administration: left arm). No other vaccines were given within 4 weeks. Caller has received flu Vaccine and Pneumonia Vaccine in the past and had no problem at all. Caller mentioned he will be 78 years old in May. On 10Mar2021, The patient experienced psoriasis really got bad, terrible, on both legs its been the worst ever in his 40 years, started itching/ itch like crazy, He has never seen psoriasis this bad in his life. It was up his legs, on the elbows, few patches on the sides and it had welts,, it was almost like welts or like red marks his on upper thighs and side. Caller has one big patch on the side of thigh and one in the back of the thigh. Reports the patches were always there but seems they got worse and redder. It was as red as anything up on the side, both of his legs got really big. He never saw them this bad in his life on an unspecified date. The clinical outcome of the events was unknown. Caller also inquired how long it would take to get the immunity from the 2nd dose of the covid vaccine. Patient states this has to be from the vaccine because in 45 years he has never had psoriasis this bad. As a result of the event the patient visited his Dermatologist (this was the same Dermatologist he has been going to for years. He last visited the dermatologist September or October and was given the regular cream). The caller told the dermatologist it might be due to the Pfizer Covid Vaccine, and the dermatologist said it may be due to stress. Patient stated he is not under stress or stressed out. Caller states he uses different creams, but clarifies the one his dermatologist gave him as treatment is called Betamethasone Dipropionate cream 0.05. Caller states he was given him 3 tubes of cream because the caller guesses his psoriasis is so bad. Caller reported a little improvement, stating it doesn't itch as much he guesses because of the cream. He sees his leg is all red, almost looks like shingles. He clarifies the psoriasis is on both legs and calves, but one calf is not as bad; on his thigh, on the side, and one patch is on the back of his thigh. He has had Psoriasis on both legs as years went on but very little. The cream helped out, also sun and salt water,, but he's never seen it this bad. Everything broke out like crazy. No Follow-up attempts are needed. No further information is expected. The clinical outcome of the events was recovering while almost looks like shingles was unknown. No Follow-up attempts are needed. No further information is expected.

welts in the arm and in the leg; This is a spontaneous report from a contactable consumer (Patient). A 77-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN0151), via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:00 as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications were not reported. After 2 days he got small scratches on my hands, arms, neck, chest and face at 11:30 those of the hand disappeared those of the arm lasted two days together with those of the neck those on the chest, a very large slot was made from the size of the hand to the height of the heart and he still have it tomorrow it is already a week of the second dose of the vaccine those on the face on the right side disappeared after 2 days, those on the left side swelled up or grows a lot have gone decreasing but are still present and he started to leave today welts on my arm and leg on 05Apr2021. Treatment received with Benadryl. The outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.

05/03/2021 I awoke and I had multiple joints hurting when I got up at 5:20 to go to work..During the day Monday, I had to take 1 turmeric pill for pain. The pain went away. Monday night I was extremely sleepey, and when I woke up to go to bed about 11:30 I notice some of the joint pain had came back esp the left arm. 05/04/21 , I noticed the area around the v site on the left arm had a red rash about 3x34" and a knot about the size of a golf ball raised and very hard. Joints were hurting in L arm, legs, and right arm and wrist. About 10 AM i took 1 ALEVE and within 2 hours the rash was almost gone on L arm at v site, and the swelling at the v site was also getting smaller. Took 1 more ALEVE at the time point and I felt fantistic. Same as today, great day, no pain.

shingles; so he thought it was just a pulled muscle; Back pain; soreness in the arm; This is a spontaneous report from a contactable other health professional via the Pfizer-sponsored program. A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 77-years-old), administered in Arm Left on 26Jan2021 13:30 (Lot Number: EL9263) as 1st dose, single for COVID-19 immunization. Medical history included penicillin allergy. It's been 25-30 years ago and he can't take it. He gets swollen and hives and sick. There were no concomitant medications. The patient previously received a shingles shot about 5-6 years ago and flu shot Nov2020. The patient experienced soreness in the arm on 26Jan2021, back pain on 30Jan2021, so he thought it was just a pulled muscle on Feb2021, shingles on 15Feb2021. The patient received the first COVID shot on 26Jan2021 and didn't really have a reaction, but soreness in the arm a couple of days. He then started having back pain and he is a very active person so he didn't think anything of it. Spouse told him that he needs to see the doctor because she thought he had shingles. They do not know if it's associated to the COVID shot or not. They need to also cancel his appointment for tomorrow because the doctor does not want him to get his second COVID shot since he is on medication for the shingles. Mentions again, his arm was a little sore, but then 4 days after that he had back pain. He is an exceptionally active person, and excavation construction worker and still works and so he thought it was just a pulled muscle. Then a few days later, pain was awful and area was sensitive to touch and it looked a little swollen and he had nothing else. A couple days later he kept saying it bothered him and it was all the way around to his side. It was fine at first it started with a little rash and so he went to the doctor today and diagnosed with shingles. Therapeutic measures were taken as a result of shingles which included valacyclovir (Was given Valacyclovir 1 gram tablet to take three times daily to help the shingles). Adverse events required a visit to Physician Office. The outcome of the event "soreness in the arm" was recovered on 28Jan2021, for Back pain and shingles was not recovered, for "so he thought it was just a pulled muscle" was unknown. No other vaccines given the same day or 4 weeks prior. No problem with vaccines in past. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of Herpes zoster,sorenessin the arm,backpain,pulled muscle cannot be excluded.But also consider.medical history of allergic drug history and other relevant medical history.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

flushed; elbow hip pain covid; elbow hip pain covid; appearing toes red swollen painful; appearing toes red swollen painful; appearing toes red swollen painful; elbow hip pain covid; This is a spontaneous report from a contactable other hcp (patient). A 77-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: el3247), via an unspecified route of administration in arm left on 19Jan2021 at 08:30 AM as single dose for COVID-19 immunisation. Medical history included htn (hypertension). Patient had allergy from Indocin. Concomitant medication included (other medications the patient received within 2 weeks of vaccination) lisinopril (LISINOPRIL). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 at 08:30, the patient experienced flushed, elbow hip pain covid appearing toes red swollen painful still on day 8. The events were considered as non-serious. Patient reported no for seriousness criteria-results in death, seriousness criteria-life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating and seriousness criteria-congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Treatment was received for the adverse event (home care). The outcome of the events was reported as not recovered. Follow-up attempts are completed. No further information is expected.

red blotches on his back and looked in mirror and saw it all on his legs and thighs and it was coming through skin.; feel something under skin; looked like red rash broke out on his thighs and seemed like the shingles; looked like red rash broke out on his thighs and seemed like the shingles; muscle spasms on the left side of his back; Stiffness and it was hard to straighten up, and it was catching in his left hip and lower part of his back and it was pretty severe; Stiffness and it was hard to straighten up, and it was catching in his left hip and lower part of his back and it was pretty severe; 2nd dose, 3 mg single; This is a spontaneous report from a contactable consumer (who is also the patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration, administered in the left arm, on 01Mar2021 (also reported as 02Mar2021) a little before 10:00 close to an hour after arriving at 09:00, as 2nd dose, 3 mg single, for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), administered in the left arm shoulder, at 0.3 mg, for COVID-19 immunization. On 02Mar2021, the patient started having muscle spasms in the lower part of his back. The patient clarified that the muscle spasm was on the left side of his back which was the same side as the vaccination. On the same day, 02Mar2021, the patient experienced stiffness and it was hard to straighten up, it was catching in his left hip and lower part of his back and it was pretty severe. On 05Mar2021, the patient could feel something under his skin that looked like red rash broke out on his thighs and seemed like the shingles or something and he didn't know what that was. He stated that he saw red blotches on his back and looked in mirror and saw it all on his legs and thighs and it was coming through skin. The patient was recovering from muscle spasms, stiffness, and joint stiffness. The outcome of the remaining events was not recovered.

Shingles and other unknown rashes and eruptions, 1st VAX in right arm 03/02/21), 2nd VAX in left arm (03/31/21). Both arms showed shingles or shingles like symptoms. Ended up in ER today (05/22/2021) for symptoms that couldn't be resoled by dermatologist.

Within 5 days of receiving the first vaccination I got a rash under my watch band. A couple of days after that it turned into a blister. I removed the watch and the rash and blister went away. I thought it might have been the manmade material the band was made out of. So, I tried and expensive metal watchband and the same thing happened. I have tried on several occassions since to wear a watch and each time a rash has started to appear.

headache; fever of 99.9; itching from belly to knees with hives the size of quarters; itching from belly to knees with hives the size of quarters; This is a spontaneous report received from a contactable consumer reported for himself. A 77-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Expiry date: unknown), via intramuscularly, on 30Mar2021 (at 10:40) single dose on left arm for COVID-19 immunization. Historical vaccination included the patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, on 09Mar2021 (10:10). The patient medical history and concomitant medications were not reported. The patient had COVID in October 2020 and was hospitalized for 17 days. No vaccines were taken prior 4 weeks. On 30Mar2021, by evening (at 17:00), the patient experienced a fever of 99.9, headache that was the worst, itching from belly to knees with hives the size of quarters. All the events lasted for one day. Allegra tablet was taken as a therapeutic measure fore itching from belly to knees with hives the size of quarters. The reporter assessed all events as non-serious. The outcome of the events was resolved on 31Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Pain in some muscles in leg; Itching throughout body; Headaches; Chills; Dizzy at times; Pain in joints; This is a spontaneous report received from a contactable consumer. A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) as a single dose via unspecified route of 1st dose on 26Feb2021 at 8 AM for COVID-19 immunization. The patient's medical history included prostate cancer low grade, penicillin allergy and sulpha allergy. He was allergic to Gadolinium when he had it for an MRI or Cat Scan. He broke out into a rash for a few days. Concurrent medical condition and concomitant medication were not reported. Patient did not test positive before vaccination. 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. The patient believe he had COVID in Mar2020 on and off until Aug2020 but did not had any trouble breathing or fever. On 27Feb2021 20:00, the patient experienced chills, dizzy at times, pain in joints, runs, headaches and so on. Actually his normal temperature dropped from 98.4 to 96.4. When he had BNT162B2, 8 days later (06Mar2021) he had pain in some muscles in his legs and then had major itching throughout his body for about 36 hours. He took strong doses of B12, B, C, D3, Zinc, olive leaf extract, baby aspirin, Dandelion root tea. Clinical outcome of all the events were reported as recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

PATIENT CAME IN AND SAID ARM WAS SPLOTCHY WITH BRUISES AND UPPER ARM FELT KNOTTED UP ABOUT A WEEK AFTER GETTING A PFIZER COVID SHOT. PATIENT DOESN'T RECALL HITTING HIS ARM ANYWHERE. UPON QUESTIONING, PT IS ON BLOOD THINNERS. ARM IS NOT RED, RAISED, AND DOES NOT HAVE A RASH.

Muscle soreness; slight headache on top of head; hearing constant high pitched hissing noise/Wheezing sound in head, not ringing but like wheezing sound like hissing; Sore in my left arm where they give me shot; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EN6201), via an unspecified route of administration, on 03Mar2021 14:00 PM (at age of 77-year-old), as single in Arm Left, for Covid-19 immunization. The patient's medical history included high blood pressure, high cholesterol, diabetes, gout, sciatica, and penicillin allergy. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EL9262), via an unspecified route of administration, on 10Feb2021 14:00 PM (at age of 77-year-old), as single in Arm Left, for Covid-19 immunization. The patient's concomitant medications included telmisartan (MICARDIS) at dose of 80mg per day, insulin glargine (LANTUS), clonidine (CLONIDINE), simvastatin (SIMVASTATIN), gabapentin (GABAPENT) and insulin (INSULIN) taken for diabetes mellitus. Prior to vaccination, the was not patient diagnosed with COVID-19 and since the vaccination, had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient stated that he had second dose on Pfizer, on 03Mar2021 (on last Wednesday). He was a veteran and had the shot 2 o'clock in the afternoon. Then six hours after his shot, he had the sore in his left arm where they give him shot and then he had sore. He had little bit of headache, but not much so he took some Tylenol as a treatment. The next day, Thursday it disappeared, and he had little bit of sore, but his headache seems like disappeared. But, yesterday around noon time he suddenly heard wheezing sound in his head, he thought it was from his ear, but it was not, it felt like inside his head. It was like a wheezing sound, not ringing but like wheezing sound like hissing, something like that. Sometimes it was little bit higher, sometimes it was low. Right now, it was steady on, the sound was still there but he could hear everything plus the sound that made, therefore he called if it was normal or side effect of what he had. He tried to call his doctor today (on Saturday) but he never answered yet, so he had to call and report. The patient confirmed that it was after the second dose of Pfizer vaccine. On 03Mar2021 16:00, the patient experienced sore in my left arm; slight headache on top of head; hearing constant high pitched hissing noise/wheezing sound in head, not ringing but like wheezing sound like hissing; and sore in my left arm. The patient received treatment for the event headache. The patient was provided with the number of Pfizer Medical Information. The outcome for the reported events was not resolved. No follow-up attempts are needed. No further information is expected.

Patient presented to the ED on 6/7/21 with worsening redness and swelling of his legs. He had presented to the ED with the same complaints on 5/29/21 but was discharged back to his group home. On the 5/29 visit, he was tested for COVID as part of standard protocol, and was found to be COVID positive (asymptomatic) despite receiving 2 doses of Pfizer vaccine (1/15 and 2/5). On the 6/7 ED visit, pt was initially found to be hypoxic (89% on room air) in the ED, but once he was admitted and transferred to the COVID floor, he was found to be 95% on room air and supplemental O2 was discontinued. Patient has remained asymptomatic for COVID during his hospitalization, and has not required COVID treatment.

Shingles; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206, Expiration Date: was not reported), via an unspecified route of administration, administered in Arm Left on 07Mar2021 as a SINGLE DOSE for covid-19 immunization. The patient's medical history included hypertension. The patient previously took diphenhydramine and experienced drug hypersensitivity and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM9810, Expiration Date: was not reported), via an unspecified route of administration, administered in Arm Left on 07Fb2021 12:15PM, as a SINGLE DOSE for covid-19 immunization. Concomitant medications included Benazepril, baclofen, Hydrochlorothiazide and cyanocobalamin (B-12). No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On an unspecified date Mar2021, the patient experienced shingles. No treatment taken for adverse event. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.

Rash; Itch all over my body - second dose; Hard time breathing through mask - second dose; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0150, expiration date unspecified), via an unspecified route of administration, administered in Arm Right on 21Apr2021 12:15 as single dose for covid-19 immunization. Medical history included Broke femur of right leg from 09Nov2020 to 09Nov2020 (he was hospitalized for the broken femur from 09Nov2020 until 15Nov2020 or 16Nov2020), Surgery to repair broken right femur from 12Nov2020 to 12Nov2020, ongoing COPD (Chronic obstructive pulmonary disease) (Chronic COPD, he was diagnosed with chronic COPD at least 13 or 14 years ago), ongoing Asthma, on-going bronchitis, he's been in either a walker or a wheelchair (he is still not fully recovered), hospitalized for the broken femur on 09Nov2020 (reported that he was hospitalized for the broken femur from 09Nov2020 until 15Nov2020 or 16Nov2020), rehabilitation from unknown date to 14Dec2020 (reported that he had rehabilitation following his hospital discharge and got out of the rehab facility on 14Dec2020). Concomitant medications included apixaban (ELIQUIS) taken for Blood clots in leg after surgery from Apr2021 and ongoing as 5 mg, 2x/day (one in the morning and one at night). Previously the patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number CR2613, expiration date unspecified), via an unspecified route of ad-ministration, administered in arm left on 30Mar2021 as for covid-19 immunization. No additional administered vaccines. No prior vaccinations (within 4 weeks). No family medical history relevant to adverse events. He reported that what was happening was that he itches all over his body. He reported that he had little bumps and he itches all the time. Her reported that he got some anti-itch stuff and he's been putting that on it.He reported that he just did what he thought was necessary for the itching. He reported that he thought he could take anti-itch stuff and try to correct it that way, but he was still itching. He stated that naturally you say not to itch, but he still itches and he scratches. He reported that he guesses the scratching makes it worse. He reported that his children recommended that he take Benazine or something so that is what he has been doing. He reported that he just got out of the hospital anyway because he broke his femur.He reported that he's been in either a walker or a wheelchair and that he is still not fully recovered from that, so that was one of his deals. He reported that he also has blood clots. Reported that the itching seems a little better but right now it was on his back and it was difficult to put the cream on there. The rash started on the second day, he started itching on the back of his head, he thought it was dandruff or something, so that happened the first day after, and the following day he got itching all over. Was using some itching stuff they get from the pharmacy, they said take certain meds, so he talked to the pharmacy about that, his wife did, and he started doing that, but it's continued on for a week, he did not know if he was doing ok, or if he should be doing something else, or continuing doing what he is doing. Trouble breathing through mask: He reported that he received the Covid-19 vaccine at 12:15 PM on 21Apr2021 and he had physical therapy at 3:00 PM following the vaccine. He reported that he then had a hard time breathing through his mask at physical therapy. He reported that he always has a hard time breathing one way or the other, and that the difficulty breathing through his mask was present before he received the Covid-19 vaccine. Blood clot in leg: reported that after he was discharged from rehab, he went to his own family doctor because his ankle and leg were still swollen. He reported that his physician sent him to (place name) to have a vascular done. He reported that the physician in (place name) determined that he had blood clots in his leg. He reported that he was sent to the emergency room and he started that stuff for about a week until he went to a regular vascular doctor and the physician determined what the caller should be doing. He reported that he was diagnosed with the blood clots after he got out of rehab at (place name). He reported that he went to see his regular doctor on 30Mar2021 and that it had to be after that that they sent for vascular. Rash: His wife reported that the caller has been scratching himself bloody. His wife reported that the rash came out on Friday, 23Apr2021. He reported that he was in a wheelchair. He reported that he has been using anti-itch products but is still itching. His wife provided product details. His wife reported that the patient has already used one tube of the Benadryl Anti-Itch cream. Benadryl Anti-Itch Cream (second tube): Strength: Diphenhydramine 2%, Zinc Acetate 0.1%; Package size: 1 ounce tube; Lot Number: 0051LZ; Expiration Date: Nov2022, Benadryl Tablets: Strength: 25 mg tablets; Package size: 100 tablets; Lot Number: KHL0001; Expiration Date: Jul2022, Benadryl Liquid Capsules: Strength: 25 mg capsules; Package size: 24 caplets; Lot Number: 1795511; Expiration Date: Jul2022, Benadryl Extra Strength Itch Stopping Cream (first tube): Package size: 1 ounce tube; Lot Number: 3290LZ-1; Expiration Date: Oct2022. There was product complaint. Patient was using Benadryl tablets, Benadryl Anti-Itch Cream, and Benadryl Liquid Capsules and is still itching. The imprint with lot number and expiry date on the Benadryl Extra Strength Itch Stopping Cream was little hard to read. Benadryl Anti-Itch Cream (second tube): Strength: Diphenhydramine 2%, Zinc Acetate 0.1%; Package size: 1 ounce tube; Lot Number: 0051LZ, Benadryl Tablets: Strength: 25 mg tablets; Package size: 100 tablets, Benadryl Liquid Capsules: Strength: 25 mg capsules; Package size: 24 caplets, Benadryl Extra Strength Itch Stopping Cream (first tube): Package size: 1 ounce tube. Additional lot numbers: Benadryl Anti-Itch Cream (second tube): Lot Number: 0051LZ; Expiration Date: Nov2022, Benadryl Tablets: Lot Num-ber: KHL0001; Expiration Date: Jul2022, Benadryl Liquid Capsules: Lot Number: 1795511; Expiration Date: Jul2022, Benadryl Extra Strength Itch Stopping Cream (first tube): Lot Number: 3290LZ-1; Expiration Date: Oct2022. Sample of the product available to be returned, if requested. Packaging sealed and intact. The outcome of breathing difficult and itchy was not recovered, rash was unknown. No follow-up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021479091 same patient, different dose/event

very mild soreness at the injection site when touched; This is a spontaneous report from a contactable consumer (patient) reported for himself. This consumer reported similar events for two patients (husband and wife). A 77-year-old male patient received bnt162b2 (Lot Number: En6204; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in left arm on 11Mar2021 (at the age of 77 years old) as single dose for covid-19 immunization. The patient previously received bnt162b2 (Lot Number: En6201; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in left arm on 18Feb2021 at 11:00 AM (at the age of 77 years old) as single dose for covid-19 immunization. Medical history included diabetes, enlarged prostate, and the patient had known allergies. The patient had no other vaccine in four weeks. Concomitant medications in two weeks included metformin, glimepiride, tamsulosin, latanoprost. Neither his wife nor he had any adverse event other than very mild soreness at the injection site when touched on 11Mar2021 11:00 AM. How can they be sure that the vaccine was viable or if it was not temperature controlled not effective. He was concerned. The patient had not COVID prior vaccination and did not have COVID tested post vaccination. No treatment for the event. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021290939 same reporter/drug/AE different patient

red spots on feet that kept getting worse and traveled up lower extremities. He went to dermatology at UH and had biopsy completed which is being further evaluated with lab testing. Final diagnosis biopsy results: interface dermatitis with a lymphocytic infiltrate and erythrocyte extravasation. These findings could be seen in pigmented purpuric dermatosis, a drug eruption,, viral exanthem or connective tissue disease such as a cute cutaneous Lupus erythematosus, subacute cutaneous lupus erythematosus and dermatomyositis.

RASHES ON FACE, ARMS, LEGS, SCALP & SCALP HAS LARGE SPOTS WHERE THERE IS NO PIGMENT. THE DR. HAS PRESCRIBED TOPICAL MEDICATION WHICH IS HELPING

Grover's disease; rash is on my back, on my chest and abdomen; Grover's disease; rash is on my back, on my chest and abdomen; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ELM9810), via an intramuscular route on 04Feb2021 at 13:30 (at the age of 77-years) as 2nd dose, single in the left arm for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications included Tamsulosin tolterodine for bladder control, Multiple vitamins & mineral supplements from unknown dates and unknown if ongoing and Betamethasone, hydrocortisone (CORTIZONE) for Grover's disease rash from 04Feb2021 to 15May2021. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3249), via an intramuscular route on 14Jan2021 at 13:30 (at the age of 77-years) as 1st dose, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Feb2021, the patient experienced Grover's disease; rash is on my back, on my chest and abdomen. Patient stated that he consulted dermatologist and he identified a rash and identified it as Grover's disease rash. He noticed it was developing in February. It was diagnosed on February 18th. He did not think it might result from the vaccine but he still nursing it, it had gotten better. He suggested, patient should call just to double check. Patient wants to knew whether or not, this rash might have resulted from the vaccine. The patient underwent lab tests and procedures which included Dermatology tests for annual physical was Minor skin lesions on 18Feb2021. Patient stated that he had a blood test. It was good, no problems. Blood test was on 09Mar2021, just a part of my general physical and everything was okay. Patient stated that It's getting better but it still hadn't gone away. He was treating it with Betamethasone and not Cortisone ointment. He finished with the betamethasone and now treating it with Cortisone. The patient visited to physician office. The outcome of the event was recovering. Follow-up attempts are possible. No further information is expected.

Accident with left arm/banging his arm into the chair and it ripped the skin on the top layer of his arm; Accident with left arm/banging his arm into the chair and it ripped the skin on the top layer of his arm; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 77-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EI.9267), via an unspecified route of administration, administered in Arm Left on 09Feb2021 13:30 as single dose for COVID-19 immunisation. The patient was taking COVID Vaccine Right thing to do and also high risk because has Type II Diabetes. Medical history included ongoing Diabetes Type II, Blood pressure high, dry eye, Neuropathy, patient was allergic to a number of medications and allergic to certain things (but not sure if those are considered a vaccine), allergic to Penicillin and Tetracycline and eye stroke (Doctor told to take because has dry eye and was informed could get something referred to as eye stroke). Concomitant medications included BAYER ASPIRIN, 81 ng, daily for Blood pressure, Gabapentin 400 mg, five a day for neuropathy, Glipizide 5 mg, two pills two times daily for Diabetes, Lisinopril 20/25 mg once a day for Blood pressure high, and Systane ultra twice daily for dry eye and eye stroke. The patient previously took tetracycline and experienced drug hypersensitivity. It was reported that patient was not prior vaccinated within 4 weeks. On 02Mar2021, the patient experienced accident with left arm/banging his arm into the chair and it ripped the skin on the top layer of his arm which was considered serious as medically significant event and for which patient visited to local emergency room but not physicians office and the HCP gave him a tetanus shot. The doctor there said he would not have any problems with getting the second shot. It was reported that patient was supposed to get his 2nd dose on 02Mar2021 but due to the storms) they were not able to get the vaccines in on time and his appointment was changed to next Tuesday. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.

a red rash and itching around the injection site; a red rash and itching around the injection site; red doughnut like area around the injection site; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EL9263) via an unspecified route of administration in left arm (upper left shoulder area) on 25Jan2021 at 19:00 as single dose for COVID-19 immunisation. There were no additional vaccines administered on same date of the Pfizer Suspect and prior vaccinations (within 4 weeks). The patient's medical history had pacemaker. Patient's Medical History (including any illness at time of vaccination) was none. No historical vaccination, he has never had a reaction to a vaccine. Concomitant medications were not reported. On Saturday 06Feb2021, the patient started experiencing a red rash doughnut like area and itching around the injection site. He was due for his second dose and wants to know if he should be concerned. The patient explains he got a shot about 3 weeks ago and thinks he was having a reaction. He explains he has a red doughnut like area around the injection site. It is round and with little dots and was red. He was wondering if that was something to worry about and was this serious. He was scheduled for the second dose in the next 2 or 3 weeks and wants to know should he get the second dose. Adverse event following prior vaccinations was none. There was no family medical history and tests relevant to adverse event. His wife put a little cortisone cream as treatment to help with the itching. The outcome of the event was not recovered. Follow-up (09Feb2021): New information from same consumer included: Patient details, Relevant medical history, Product and events details and clinical information added. Follow-up (11May2021): Follow-up attempts completed. No further information expected.

Hives; Bruising; Fever of 102, almost 103; GI problems; This is a spontaneous report from a contactable consumer (patient). This 77-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 05Mar2021 18:00 (Batch/Lot number was not reported) (at the age of 77-year-old) as dose 2, single for covid-19 immunisation. Medical history included blood pressure abnormal (was taking blood pressure medications to bring it normal), hard of hearing with hearing aids. Concomitant medication(s) included Losartan taken for blood pressure. Patient received first dose of BNT162B2 on 10Feb2021 06:00 PM (Lot number: EL3247). Patient was reporting a possible side effect from the Pfizer COVID shot in March. Around 02Apr2021 patient had hives, the broke out and he went to different doctor, dermatologist, the allergist, regular doctor. He was in the hospital for 3 days because the hives were actually pretty bad to the point where they were bruising and the blood vessels were 'worsening' from the top of head to the sole to feet, every part of the body. Now patient tried 3 times to get rid of them by using Prednisone given by doctor and the antihistamines. As soon as go off to Prednisone the hives come back and retrieved. Patient did all kind of test for that and never find what's causing the problem, doctors couldn't find the cause of hives. The only thing they point to, is the fact that the month patient had the vaccine shot that developed this, 3 times. Patient got the both shots the first and the second shots and after the second shot, the day after he developed fever of 102, almost 103 and that pretty well went away, they said that could happen and that did. It went away after one day and he was fine, then this other stuff started later. Patient was experiencing lot of GI problems, he thought this is due to COVID shot. Treatment included Prednisone, Antihistamine (Unspecified Medication) as well Allegra, Zyrtec and Benadryl. when he was on prednisone, the hives went away. When off Prednisone they came right back. When went down to lower doses, they came right back again. He was not taking Prednisone anymore. The outcome of Fever was recovered, of other events was not recovered. Information on lot/batch number has been requested.

Rash lower back, itching on back, leg, lower stomach.; Rash lower back, itching on back, leg, lower stomach.; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) solution for injection, via an unspecified route of administration on left arm on 07Jan2021 17:15 at a single dose for COVID-19 immunization. Medical history included hypertension, kidney disease stage 3, UTI (urinary tract infection), enlarged prostate, and known allergy to penicillin. Concomitant medication included amlodipine, benazepril, tamsulosin, ergocalciferol (VIT D), and unspecified multivitamin. The patient experienced rash lower back, itching on back, leg, lower stomach on 09Jan2021 at 2pm. No treatment received. The events were reported as non-serious. The patient was not diagnosed with Covid-19 prior to vaccination. The patient has not been tested for Covid-19 since the vaccination. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

hypoxemia, urinary retention Narrative: Transferred from facility to ED with 1 day of fevers, hypotension, and c/f new oxygen requirement and admitted to acute care ward on 1/14/21. Tachycardia resolved w/ fluids. Patient was ruled out for PE and infectious workup negative. Fevers, hypoxia resolved overnight. Medicine Team felt symptoms were side effects from COVID vaccine (2nd dose received 1/13). He was treated for possible cellulitis at L shin wound (warm and tender to touch with mild erythema, without fluctuation) with 14-day cephalexin course, however cellulitis not deemed severe and unlikely contributing. Regarding urinary retention, the Discharge Summary stated, "Urinary retention seemed new in the last day. Pt on condom cath during admission, urinating well." Discharged 1/15/21 and returned to facility.

headache; chills; fever; muscle soreness; injection site soreness; This is a spontaneous report from a non-contactable consumer (wife). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 14Jan2021 19:00, the patient had headache, chills, fever, muscle soreness and injection site soreness. Outcome was unknown. Information on batch number has been requested.

Pt complains of itching, redness, and bump at vaccine site on left deltoid which started last night. Pt useing hydrocortisone cream and was given oral Prednisone 10mg x 5 days.

injection site pain to right arm; Chills; Headache; light fever; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELL742) on his right arm, via an unspecified route of administration on 14Jan2021 07:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got injection site pain to right arm, chills, headache and a light fever; all on 14Jan2021 19:00. It was also stated that the injection site pain was severe and is now less. Also reported that the patient recovered from the chills during the night completely. The patient took a couple of aspirin last night and will take some more this morning as treatment. The outcome of the event chills was recovered on 14Jan2021, not recovered for event light fever while recovering for the remaining events.

site soreness; nasal stuffiness; difficulty breathing; throat began closing up; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient (also reported as age at vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982), via an unspecified route of administration on 14Jan2021 at 12:00 at a single dose on the left arm for COVID-19 immunization. Medical history included two recent right shoulder surgeries. Concomitant medication included oxaprozin. The patient previously took oxycontin and experienced allergies and an unspecified allergy shot last 06Jan2021 on the left & right arm. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021 at 01:30, the patient was having difficulty breathing and throat began closing up. Patient's wife was going to call 911 but after about an hour, incident appeared to be getting better. On the next day (16Jan2021), the patient felt better with minor site soreness and nasal stuffiness. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.

Sore arm at site of injection; balance problems (from a couple hours after injection continuing and worsening somewhat morning after.

terrible headache lasting 3 days after injection; elevated temperature on day 2 of 102; sore and red arm at injection site; sore and red arm at injection site; body aches; This is a spontaneous report from a contactable Consumer. A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number PFREL3246), via an unspecified route of administration on 09Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included COPD, Asthma, Atrial Fib, Hypertension, covid-19. The patient previously took levaquin and underwent allergies:Levaquin. The patient experienced body aches, elevated temperature on day 2 of 102, sore and red arm at injection site, terrible headache lasting 3 days after injection. No treatment received. No Covid tested post vaccination. The outcome of the events was resolved.

I had some pain around the shot area; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 at 14:30 at single dose in left arm for COVID-19 immunisation at the age of 78-year-old. Lot number was EL3302. The medical history and the concomitant medications were not reported. The patient had some pain around the shot area on 19Jan2021 at 17:30 and he took TYLENOL, 2 tablets 500 mg each within 4 hours of receiving the shot. 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 recovered from the event.

the injection site started to inch and it got a red blotch about 2 inches in diameter; the injection site started to inch and it got a red blotch about 2 inches in diameter; soreness; This is a spontaneous report from a contactable consumer reported for himself. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247) via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. Medical history included idiopathic thrombocytopenic purpura (ITP). Concomitant medications included romiplostim (NPLATE) for ITP. The patient stated he received his first dose of the vaccine on 15Jan2021, some soreness on 15Jan2021 afterwards but nothing that noticeable and about a week later on the 22Jan2021, the injection site started to inch and it got a red blotch about 2 inches in diameter. Just about it started a week after the injection. So, he was wondering if that was to be expected or was it unusual or how he should proceed. The events were reported as non-serious. No treatment received for events. Due date for the next shot was 05Feb2021. The outcome of event the injection site started to inch and it got a red blotch about 2 inches in diameter was not resolved, and of soreness was unknown.

His left foot was swollen up really bad, red and tender and he could not walk on it; His left foot was swollen up really bad, red and tender and he could not walk on it; His left foot was swollen up really bad, red and tender and he could not walk on it; His left foot was swollen up really bad, red and tender and he could not walk on it; This is a spontaneous report from a contactable consumer (patient's wife). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261 with Expiration Date 31May2021), via intramuscular, on 22Jan2021 (at 09:00) at a single dose on the left arm for COVID-19 immunisation. Relevant medical history included ongoing restless legs syndrome and ongoing acid reflux. Relevant concomitant medications included omeprazole ongoing from an unknown date for acid reflux and gabapentin ongoing from an unknown date for restless legs syndrome. Her husband had the injection on Friday 22Jan2021. The next morning his left foot was swollen up really bad, red and tender and he could not walk on it. He has had problems like that before and he had it checked and was told it is not gout. It did not go away and she called the nurse on Sunday morning, and the nurse did not think it was a reaction and told her that a lot of times it is swelling in the lymph nodes. He was advised to go and see a podiatrist on Monday. He saw the podiatrist yesterday morning and the podiatrist gave him a one injection that contained Lidocaine, dexamethasone, and depomederol. After injection, the swelling right down and his foot was ok. The patient went to go get the Moderna injection and she asked those giving the injection if it was ok for her husband to get that injection from the podiatrist. She was told that people are not supposed to take paracetamol (TYLENOL) or ibuprofen. She was told that they did not think it was a good idea for her husband to get that injection from the podiatrist and it may have wiped out the benefit of the Pfizer COVID VACCINE. His foot was 95% recovered, he could walk on it and the swelling was down. The patient was recovering from the events.

Itching, rash all over body, large blisters on chest and face. Started exactly 24 hours after 2nd shot. came very fast , within five minutes of no problems.

On 2/5/21 I noticed a rash on the upper right portion of my back. I confirmed with Doctor that this was the shingles virus and he prescribed Valacyclovir HCL 1 Gram,1 tablet 3 times per day, which has now begun to clear up the rash.

Injection site developed numbness and tingling of left arm that began 45-60 minutes after reciving the vaccine on 2/8/2021. Resolved within an hour or so, then no strength between thumb and index finger. Symptoms resolved that night. On 2/10/2021 patient had difficulty picking up things and had less strength than usual. Patient stated he felt clumsy.

First shot on 01/18/21: Very mild case of hives across upper chest from shoulder to shoulder Second shot on 02/13/21: More severe but still mild case of hives across entire chest from shoulder to shoulder NB: Have never previously experienced a case of hives or any adverse reaction to vaccination in my entire life

Have constant pain in right upper arm shoulder, have taken Ibuprofen 800mg per day reliefs pain for about 12 hours. My arm movement seems to be good and is not painful when I move it. I have to elevate my arm in a sling type position as the day goes on it gets more painful otherwise. I have called my doctor but have not heard back from him, I am expecting him to call me today, so I can get his opinion on what might be wrong with my shoulder. I have my second virus short scheduled for Feb. 25,2021 at 9:30 am at the same place.

This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248), via an unspecified route of administration on 23Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient had soreness in the shoulder for only one day and he had bruising. No treatment received. The outcome was unknown.

First dose given 01/21/21, 2nd dose February 11th 1:30 pm Both first and second dose, first dose only soreness at injection site, second dose had soreness, nausea, cramps in stomach, wheezing, fatigued, chills, vomiting,, diarrhea Symptoms have mostly subsided, just a little stomach craming and fatigue

shingles on right upper arm which is clearing up now after 2 weeks. Still some aching in right shoulder

Dizziness; Hypoglycemia; Hypotension; Generalized rash; This is a spontaneous report from a non-contactable healthcare professional. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318; dose 1) intramuscularly on 25Jan2021 (at the age of 78-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history and concomitant medications were not reported. On 25Jan2021 during the 15 minute waiting period after the vaccine, the patient experienced dizziness. He denied difficulty breathing and swallowing. A differential diagnosis of systemic reaction (hypoglycemia, hypotension, generalized rash) was provided. The patient was given unspecified treatment and follow-up response was good. The patient denied dizziness when standing up and walking to leave the medical evaluation bay and clinical outcome of dizziness was completely resolved prior to discharge. No follow-up attempts are possible. No further information is expected.

Low grade fever on 2.24.21, severe pain in the left skin dermatome under the left nipple, redness size of 3x2 inches with several small blisters under the left nipple, area is very sensitive to touch by clothing Tramadol 3 times a day The redness is not getting larger, but the pain is not abating

severe edema lower extremities Both feet red and swollen pustular rash all over the abdomen, back,legs, and arms severe itching

Experiencing extreme itching on site of vaccine.; This is a spontaneous report from a contactable consumer reported for himself. A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot # EN6201, via unknown route at left arm on 18Feb2021 at 12:15 (at the age of 78-year-old) at single dose for covid-19 immunization. The patient received the first dose of the same vaccine on 28Jan2021 at 12:15 AM at the left arm from lot # EL3248. The patient experienced extreme itching on site of vaccine. The outcome of the event was not recovered. No COVID prior vaccination. Patient has not been tested for COVID-19. Adverse event result in hospitalization, Life threatening illness, Disability or permanent damage, Congenital anomaly.

Mild soreness at the injection site; This is a spontaneous report from a non-contactable consumer (patient). A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EM9809), via an unspecified route of administration on left arm on 08Feb2021 at the age of 78 years old at a single dose for COVID-19 immunisation at Doctor's office/urgent care. Medical history included high cholesterol. Allergies to medications, food, or other products was none. Concomitant medications included unspecified medications. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received at the age of 78 years old on an unknown date for COVID-19 immunization. On 08Feb2021, the patient experienced mild soreness at the injection site. The patient assessed the event as non-serious. It was unknown if the treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the event. No follow-up attempts are possible. No further information is expected.

Right arm was barely sore where injection administered; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of BNT162B2 (Lot number: EL0142), via an unspecified route of administration on 11Jan2021 17:05 at single dose in the right arm for vaccination. Medical history included eye vitamin/To maintain good eye health, eye disorder, Heart supplement, heart disorder and he had his last annual physical with Pneumocystis pneumonia (PCP) in Oct2020. He had his flu shot in Sep2020. Concomitant medication included ramipril taken for probably at least 15 years, started in his 60s; atorvastatin taken for probably at least 15 years, started in his 60s. He believes this is the generic product for Pfizer Lipitor; acetylsalicylic acid (ASPIRIN CHILDREN) taken for probably at least 15 years, started in his 60s; ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS) (also reported as "Advanced Retinol Eye Study Disease") for eye vitamin/To maintain good eye health; bioflavonoids nos, lecithin, quercetin, ubidecarenone (CO-Q-10 PLUS) taken for probably at least 15 years, started in his 60s for Heart supplement; and unspecified multivitamin taken daily and probably taken all his life, all ongoing. This patient reported he was administered his first dose of Pfizer COVID-19 vaccine on 11Jan2021. There were no side effects; his right arm was barely sore where injection administered on 11Jan2021. Onset probably about 19:05-20:05 and he had recovered completely by the next morning when he woke. He had no discomfort during the night, no pain or throbbing, he felt very normal the next morning. He clarified that he has no medical conditions, no flu or illnesses of any other kind. He had his last annual physical with PCP in Oct2020; he has a twice yearly check-up with the Cardiologist that will be coming up soon. Stated that today is the 21st day and he is scheduled to get his second dose at 3:00pm. He asked how the incremental immunity builds up percentage wise after getting the first and second dose of Pfizer COVID-19 vaccine. He asked if there is any restriction or limitation on taking products like Tylenol, Advil or Aspirin before getting the Pfizer COVID-19 Vaccine; and if those products are ok to use to potentially treat side effects from the Pfizer COVID-19 Vaccine such as if patient has sore arm or something; and how soon after the second dose side effects can kick in-he believes the briefing documents he was given for the Pfizer COVID-19 Vaccine said 2-14 days. He asked this particularly because he has an hour drive home after this second dose and wanted to know what to anticipate before attempting to drive home. His wife thought someone told her not to take any Tylenol, Advil or Aspirin before getting the Pfizer COVID-19 Vaccine which they had not heard of elsewhere, and saw no mention of that in the briefing documents given for the Pfizer COVID-19 Vaccine. The with outcome of the event was recovered on 12Jan2021.

There was a significant drug interaction with Efudex Cream that I was applying topically to a pre-cancerous 2-cm-diameter lesion on my left shin. On the day of my first Pfizer shot, the Efudex treated lesion was progressing normally from the desquamation (scabbing and shedding of epithelial scales) to the erosion stage (starting to form a shallow 2.5-cm-diameter ulcer). Starting about Saturday 30 January (three days after the first Pfizer shot) and slowly increasing for the next four days, the Efudex-treated ulcer became deeper, the peripheral 12-cm-diameter skin became redder, and the left foot and ankle became increasingly swollen. My RN-wife and I (a former medical-research physicist) began research andChronic health conditions: nasal polyps, precancerous bleeding actinic keratoses, Cramp-Fasciculation Syndrome (leg & foot cramps), early macular degeneration bilateral, hearing loss bilateral. Chronic health conditions: nasal polyps, precancerous bleeding actinic keratoses, Cramp-Fasciculation Syndrome (leg & foot cramps), early macular degeneration bilateral, hearing loss bilateral.DVERSE EFFECTS, TREATMENT, AND OUTCOME: discovered that Efudex should not be given concurrently with any of a long list of immunizations. This is an Efudex problem that should gain another immunization onto that list. Being within a week of finishing the Efudex regimen, we monitored the Efudex-treatment area and the peripheral area carefully. On Thursday 4 Feb (eight days after the first Pfizer shot), the ulcer began unusual drainage, the 12-cm-diameter peripheral area became inflamed, and swelling of the left ankle and foot increased to almost skin-tight - I can upload photos if you need. Time for immediate action. My excellent Dermatologist stopped Efudex and started me on Bactrim by mouth for 10 days, and Gentamicin topical antibiotic on the ulcerated central area and Triamcinolone topical corticosteroid on the peripheral and swollen areas for three weeks. Good choices. Improvement was immediate and continued improving for the next three weeks. By the time of the second Pfizer shot on 24 February, the central area was healing well, in the late-reepithelialization stage (regrowth of epithelial tissue that now formed a completely-covering scar tissue with no oozing), and with all inflammation and swelling completely gone. After the second Pfizer shot (taken 20 days after stopping Efudex), there were zero adverse effects of any kind. NOTE: There were absolutely zero other adverse effects of any kind throughout the entire series: no chills, fever, headache, nausea, vomiting, diarrhea, change in pulse or blood pressure (120/70 range), loss of taste or smell, sore throat, cough, lung congestion, fatigue, feeling of being unwell, shortness of breath, injection-site swelling or redness, hives, swelling of face, decreased kidney function, or other adverse cardiovascular, neurological or pulmonary effects. There was no additional joint pain above my normal osteoarthritis. After both shots, I felt a slight normal-range injection-site soreness for the next few hours, but no site swelling, rash, redness, or other problem. We recommend that this immunization be added to the Efudex ‘proscribed or warned' list.

lethargic, like a big fog hit me, loss of energy, loss of balance heavy red ichy rash developed over arms, chest, waist, REALLY ITCHY Prescriptions taken: Levocetirizin E5 mg --1 tablet daily; Hydroxyzine HCL 25mg --two tablets at bedtime, 1 tab every 8 hours as needed

Shingles (shooting and sharp pain in back and chest/ ash on his chest back on rt side and under his armpit, inflamed and bubble-like); This is a spontaneous report from a contactable consumer. This 78-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot number: EN5318/exp. date May2021), intramuscular on 04Feb2021 at 07:15AM at single dose on left arm (at age of 78 years old) for covid-19 immunisation at a hospital. Medical history included was none. There were no concomitant medications. It was reported that Patient received 1st dose of BNT162B2 on Thursday, 04Feb2021. Sunday night, he started experiencing shooting and sharp pain in back and chest (on 07Feb2021). On 09Feb2021, as he was getting ready for bed, he found a rash on his chest and back on the right side and under his armpit. It was inflamed and bubble-like. He went to the doctor office this morning (10Feb2021), took his shirt off and the doctor immediately said "you got shingles". The patient was told the COVID-19 vaccine opened the door for the shingles virus to come out. He stated that the doctor put in a prescription for Valacyclovir, dose is unknown and has to take it for a week. Patient has not had prior vaccination within 4 weeks of COVID-19 vaccine.

3/16 Experienced extreme lethargy. 3/18 noticed injection site swelling and redness. There was also itching.

20 hours after Pfizer immunization C/O left hand pain with dime size hard lump located on palm of hand.

Rash appeared on chest on 2/20/21 after first shot on 2/11/21. Consulted with dermatologist . Prescribed Triamcinolone. After second shot on 3/4/21 rash moved to whole body, from head to knees two days later. (Not on face or hands). It was inflamed dots like measles or chicken pox with extreme itching. Returned to Dr. He took a biopsy and prescribed Clobetasol for head. Rash and itching increased, with welts in head and spots over body. March 18- Dr.administered a cortisone shot (60 mg.). Relief for 4 hours and then rash and itching increased. March 25- Dr. administered a second cortisone shot. No change March 26- Saw rheumatology. She prescribed prednisone 10mg twice daily. famotidine, and zyrtec (instead of Allegra). Itching and intensity of the rash (red spots) have decreased.

back started hurting/back aching and hurting; Chills; coughed once and stomach rolled; chest tightness; coughed once and stomach rolled; arm started hurting; my neck got stiff; can't sleep; This is a spontaneous report from a contactable consumer via medical information team. A 78-year-old male patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Right on 12Mar2021 11:00 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included HIV positive ongoing (Diagnosed 8 years ago); Psoriasis ongoing (over 5 years that he was diagnosed); Diabetes from 2017 and ongoing; Family History includes operation on face for melanoma. Concomitant medication included abacavir sulfate, dolutegravir sodium, lamivudine (TRIUMEQ) at 600 mg, 1x/day; then 50 mg, 1x/day; then 300 mg, 1x/day ongoing all were via orally for hiv infection; metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET XR) orally 50 mg, 1x/day for diabetes ongoing; adalimumab (HUMIRA) from an unspecified start date and ongoing at 40 mg every 14 days for psoriasis. It was reported on friday the 12Mar2021 week patient took the shot at a hospital. On the 13Mar2021 his arm started hurting and his neck got stiff. The 14Mar2021 his back started hurting like a knife, chest and back was tight. He states his back hurts and has chest tightness; coughed once and his stomach rolled up on 14Mar2021. On the 15Mar2021 same result, back aching and hurting. The 16Mar2021 he went to the hospital and took the x ray of his back and front and couldn't find nothing. States his lungs were ok and everything was ok so he doesn't know what is going on. Clarified that he went to the Emergency Room at the hospital, he was not hospitalized. He was treated in the ER and released the same day. on the 17Mar2021 his back was killing him. he can't sleep in Mar2021. He states that he still hurts this morning and has chills on 17Mar2021. The outcome of the events Cough; Stomach discomfort; Neck stiff; vaccination site pain was recovered on 14Mar2021; Chest tightness; Chills, Back pain was not recovered; Sleep disorder was unknown.

eye blurriness; gate affected; auto immune system deterioration; practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); heart/organ issues; heart/organ issues; brain fog; joint and muscle stiffness/joint stiffness; joint and muscle stiffness; blood; limb numbness/toe numbness; neurological deficit; soreness injection site; mild right temporal headache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of bnt162b2 (BNT162B2, formulation: solution for injection)Batch/Lot # EP7534, via an unspecified route of administration in the right arm on 22Mar2021 14:00 (at the age of 78-years-old) as SINGLE DOSE for COVID-19 immunization. Medical history included heart dysfunction, heart surgery, kidney function abnormal and neural dysfunction. Concomitant medication included silodosin (RAPAFLO) at 8 mg daily. The patient previously took bnt162b2 (administration date=03/03/2021, administration time=02:15 PM, vaccine location=Left arm, dose number=1). On 23Mar2021 05:45, the patient experienced auto immune system deterioration, practitioner shook bottle and injected discolored (brown) vaccine right arm (# 2 injection march 22, 2021 - 2pm), heart/organ issues (cardiac disorder), brain fog, joint and muscle stiffness/joint stiffness, joint and muscle stiffness, limb numbness/toe numbness, neurological deficit, soreness injection site, mild right temporal headache. On 24Mar2021, the patient experienced eye blurriness, gate affected. Practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection 22Mar2021 - 2pm). The patient was concerned about current and future adverse effects as it relates to auto immune system deterioration, heart/organ issues, brain fog, joint and muscle stiffness, blood, limb numbness, neurological deficit and whether such existing health issues have been exacerbated by vaccine injection : currently soreness injection site, mild right temporal headache, toe numbness, joint stiffness, 24Mar early morning eye blurriness, gate affected. The patient did not receive any treatment for the events. The outcome of the events was unknown. Follow-up (25Mar2021) and (31Mar2021): This is a follow-up spontaneous report from a contactable consumer. New information included: Lot/Batch number of the second dose, medical history updates.

#2 vaccine given R. arm 3/31/2021 Left side of face red noticed 4/8/21, today 4/14/21 very red all r side of face and neck

Received his vaccine, he had soreness in the arm, but nothing else. On 3/3/21 he went to hospital ER with diagnosis of kidney stones, had a morphine injection, Flomax and a prescription for Oxycontin and Flomax. At that time he was experiencing also in his right eye swelling and it was reddish, and there was an itching around the eye, and there was a couple blotches on top of his head and his cheek, but did not mention it as he was there for kidney stones. On 3/9/2021 he saw a Urologist, Dr. and that morning he passed a kidney stone. The urologist took an x-ray and did not see any more. The eye then became an issue on 3/9/21 and he made an appointment to see the eye Dr., Dr. at Eye institute on 3/11/21 @ 9:00 AM. The doctor diagnosed shingles on the face and right eye, and she put him on 2 medications (Durezol ophthalmic drops). He is still on that medication still 4/16/21. The other medication that they prescribed for him was Valacyclovir which he took 3 times a day, they reduced it from 1000 mg to 500 mg twice a day. The swelling of the eye itself has gone down a little bit. He is still seeing the eye doctor, and has a FU on 5/5/21 as it is getting better but still has symptoms. He did get a single dose Shingrix shot a couple of years ago.

rash; pain is coming; diagnosed with shingles; This is a spontaneous report received from a contactable consumer (patient's wife). A 78-years-old male patient received second Dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265), via an unspecified route of administration at a right arm on 12Feb202 at a single dose for covid-19 immunisation. The patient medical history included cancer, asthma. Caller states against his better judgement, has had cancer and has a tendency towards asthma, so he felt that he was at risk. Historic vaccine included first dose Pfizer Covid Vaccine, (BNT162B2, lot no: EL3246) at left arm, on 22 Jan 2021. Caller states he doesn't remember exactly, the first maybe the left arm and second in the right arm. Concomitant Products: Caller states nothing out of the ordinary, has had his routine medications. The patient's prior vaccinations were reported as none. On 22Mar2021, patient was diagnosed with shingles. On an unspecified date, Patient has rash and pain is coming. The report received as, caller states she is calling to report that after her husband got his second Covid shot on 12 FEB 2021, two weeks ago, he was diagnosed with shingles. Caller states she actually read an article online this morning with news that said some of the side effects are shingles. Caller states when he first got them, she jokingly said oh it's from the Covid. Caller states now after reading more and more, it could possibly be a side effect. Caller states they are drying up because the patient went to the clinic the same day that they noticed the rash and he got Valtrex. the rash on the right side from the middle of his belly around the side and have stopped at the spine and Caller states that stopped the progression of them. Caller states they are on the right side from the middle of his belly around the side and have stopped at the spine. Caller states there is no more breaking out now. Caller states the rash is better, but now the pain is coming. Caller states the clothing touching it is painful. Caller states the pharmacist suggested Asper cream with lidocaine because it calms the nerve pain. Caller states that helps for a while. Outcome of events was not recovered (reported as ongoing). No follow-up attempts are needed. No further information is expected.

pain in left arm (Vax site) migrated down to elbow & forearm; pain in left arm (Vax site) migrated down to elbow & forearm; pain in left arm (Vax site) migrated down to elbow & forearm; This is a spontaneous report from a contactable physician. A 78-years-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 26Mar2021 14:00 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. Medical history included osteoarthritis. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID) and finasteride (PROSCAR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain in left arm (Vax site) migrated down to elbow & forearm on 27Mar2021 with outcome of recovered. The patient received treatment: ibuprofen. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

arm was a little sore; Little rash, red dots on inside of bicep; This is a spontaneous report from a contactable consumer(Patient). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1via an unspecified route of administration, administered in Arm Left on 25Jan2021 16:35 as single dose for covid-19 immunisation. Medical history included mitral valve prolapse. The patient's concomitant medications were not reported. Had Pneumonia shot and yearly Flu shot. Had no reaction. Has no NDC/Lot/Exp to provide for Pneumonia and Flu shot. On 25Jan2021 in evening patient had a little rash on inside part of bicep. There were little red dots. It itched for a while. Next day was gone. Stated he was shrinking and provided height as 5 feet 11 inches. First time the dots were there it itched a little bit, next morning it was gone. Had no reaction to COVID-19 Vaccine. Had no fever, nothing else. Next day his arm was a little sore. Patient clarified rash and red dots occurred on both arms. Patient thought rash and red dots were something else like detergent or he didn't rinse soap off in the shower. his doctor didn't seem to think it was anything serious. No prior vaccinations within 4 weeks. Had a family medical history of diabetes runs in family, but most other people had that in their eighties and nineties.The outcome of the event little rash on inside part of bicep, little red dots was recovered on 26Jan2021 and for other it was unknown.

I have developed a very painful region in the left deltoid muscle and the right deltoid muscle is less severe. It prevents me from lifting my arm(s) higher than the elbow, and significant weakness in the both arms, especially the left. My kneecaps also have significant weakness and pains and makes standing difficult. this developed the day after the shot. I also have significant fatigue all the time since receiving the shots. The second shot (Right arm) was given March 5th.

developed rash to the chest, head and all over the body/Rash looked like measles; Scalp was extremely itchy; dermal hypersensitivity reaction; This is spontaneous stimulated report received from a contactable health care professional. A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in right arm on 04Mar2021 (Lot Number: EN2605) as single dose for covid-19 immunisation; hydrocodone bitartrate, paracetamol (NORCO), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included gastrooesophageal reflux disease (GERD), hyperlipidaemia, chronic lymphocytic leukaemia (CLL), Degenerative joint disease (DJD). No allergies to medications, food, or other products. Concomitnat medications the patient received within 2 weeks of vaccination including amlodipine, celebrex, lipitor, omeprazole. The patient previously took first dose BNT162B2 on 11Feb2021 for covid-19 immunisation via intramuscular at left arm, developed rash on chest bilaterally on 20Feb2021. Went to dermatology, doctor gave triamcinolone for treatment. The most recent COVID-19 vaccine was administered at hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Few days after second dose patient developed rash to the chest, head and all over the body. He went back to dermatology and had biopsy near his hair line. Scalp was extremely itchy, so given clobetasol. Rash looked like measles. Not on face or hands. Saw derm again on 18Mar2021, received cortisone injection with second one on 25Mar2021- first shot-4 hours of relief from itching, rash lessened temporarily and then new areas started developing. BX results (as reported): some of the features raise possibility of angiolyphoid hyperplasia with eosinophilia but favors dermal hypersensitivity reaction. No swollen lymph nodes that patient notes. Patient is extremely itchy. Taking benadryl and taking allegra during the day. Only change recently has been switching norco from 7.5/325 three times a day to 5/325 four times a day. Wonders if the increased APAP dose caused the rash. Events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Treatment received for adverse events included pepcid, benadryl, clobesatol, allegra, Zyrtec. The event outcome for events was recovering.; Sender's Comments: Based on the temporal relationship, the association between the events measles-like rash, itchiness, and dermal hypersensitivity with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Little soreness; This is a follow-up spontaneous report from a Pfizer-sponsored program. A 78-year-old contactable male consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced little soreness on the site where it has been injected. Patient took treatment as opioid (pain medication). Outcome of the event was unknown. Information on the lot/batch number has been requested.

A little over a week ago I was admitted to a local hospital having been diagnosed with Guillain?Barré syndrome, a debilitating condition where the body?s auto immune system attacks the nervous system resulting in peripheral numbness in one?s hands, feet and legs. This condition was diagnosed by a neurologist. Following his diagnosis, I spent 8 days in the Hospital and was treated for 5 days with a daily dose of 400ml of immune globulin (IVIG) to rebuild the damage to my nervous system. On April 10, I began to feel the onset of Guillain Barré syndrome as the bottoms of my feet suddenly began to tingle and feel numb. The next day I tripped while returning our waste management garbage cans to our garage. Fell face forward onto the driveway and was bruised pretty bad. The next day my BP zoomed to 224/160. 911 was called and I was taken to our local hospital fearing and thinking that I was having a heart attack. I spent 4 days in the hospital being checked for a possible heart attack and all the while my Guillain Barré syndrome was progressing undiagnosed. I was discharged and instructed to see a neurologist for the tingling and numbness in my hands, legs and feet. Within 15 minutes of the neurologist consult, a few days following my discharge, I was told I had Guillain Barré syndrome and get to a hospital. I left his office and went straight to the emergency room and I spent the next 8 days there and was discharged Tuesday, 4 May 2021. Several hospital neurologists treating me believed the vaccination triggered the syndrome as do I. It's not being widely reported even though there have been several Facebook postings of people saying the same thing as me.

On March 2, he woke up feeling bad and had a fever of 102.7. He took tylenol and liquids all day and the fever came down to around 100. The next morning he woke up complaining of excruciating pain in his left arm (site of the injection). He couldn't stand to have anything touch it, couldn't move it and couldn't sleep because of the pain. The next morning he woke up very weak, wasn't able to speak clearly, wasn't making sense. He had a telemedicine appointment scheduled that morning for another matter. The doctor took one look at him and said we should have him evaluated asap. I took him to the emergency room at Hospital. They did some tests and said he was septic and immediately put him into the ICU. He was started on IV antibiotics while the blood cultures were growing out. It was determined that the bacteria was Strep G but they were unable to identify the source. He was put on a ventilator and an echo cardiogram was done. It was believed that the source of the infection was his pacemaker and I was told the pacemaker would have to be removed. They couldn't do it at that hospital. He was transferred to another hospital. The doctors at that hospital determined the pacemaker was not the source. It was believed by some doctors that the source of infection was the injection site. The infection was cleared from his body and the ventilator was removed after 2 weeks. He lived another 2 weeks but never was able to recover. Until the day he was put on paliative care, he expressed pain in the arm where he had received the vaccination. He died at 5:30 a.m. on April 1, 2021.

During his 30 minute waiting period after the injection, the patient began to experience itching; Systemic reaction (hypoglycemia, hypotension, generalized rash); Systemic reaction (hypoglycemia, hypotension, generalized rash); Systemic reaction (hypoglycemia, hypotension, generalized rash); This is a spontaneous report from a non-contactable Other Healthcare Professional reporting for a patient. A 78-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6206) via an unknown route of administration on an unknown date as first dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, during his 30 minute waiting period after the injection, the patient began to experience itching and the differential diagnosis was systemic reaction (hypoglycemia, hypotension, generalized rash). Patient complained of itching of skin (chronic vs new itching). It was reported that patient denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, lightheadedness, dizz. Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, dizziness and headache facial swelling, lip swelling and tongue swelling. Patient was discharge as stable to go home and follow up with PCP. Patient reported immediately upon getting back to the bay that he doesn't think it's anything but his chronic itching that he gets. Patient declines feeling like this is an allergic response like he had in the past. Benadryl given as requested. The outcome of the events was unknown. No follow-up attempts were possible. No further information was expected.

Itchy red rash around neck and sides of face.; Red rash; This is a spontaneous report received from a contactable consumer. A 78-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EP 7534), via an unspecified route of administration on the arm left on 17Mar2021 at 11:30, as single dose for COVID-19 immunisation. Medical history was reported as heart disorder, diabetes, high blood pressure and allergy to bee sting and venom. Concomitant medication was reported as atorvastatin (MANUFACTURER UNKNOWN) at a dose of 80 milligram, glimepiride (UNKNOWN MANUFACTURER) at a dose of 02 milligram and atenolol (UNKNOWN MANUFACTURER) at a dose of 25 milligram for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 2 weeks prior to the COVID-19 vaccine. On 19Mar2021 7:30, the patient experienced itchy red rash around neck and sides of face and red rash. The patient did not received treatment for the reported events. Patient did not visit to the doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care for adverse event. The clinical outcome of events itchy rash was not recovered. The clinical outcome of red rash was unknown. No follow-up attempts are possible. No further information is expected.

Unbearable itching constantly from head to toe non-stop. No over the counter or prescription medicine has worked. Red marks appear everywhere before the itching starts. This is an everyday all day nerve wrecking itch ever since the second injection

Whole boy itchy skin; Skin felt like sun tan burn; Headache; Some itchy welts on stomach; This is a spontaneous report from a contactable consumer (reporting himself). This 78-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in left arm on 17Feb2021 at 11:00 as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient received unspecified medications in two weeks of vaccination. The patient did not experienced COVID prior to vaccination. The patient did not test for COVID post vaccination. The patient was allergic to penicillin. The patient's medical history and concomitant medications were not reported. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. On 17Feb2021 at 14:00, the patient experienced whole boy itchy skin, skin felt like suntan burn, headache, some itchy welts on stomach which was more severe than first dose. The evets resulted in doctor or other healthcare professional office/clinic visit. The patient took allergy consultation, prescriptions and Benadryl as treatment medication for the events. The patient not recovered from the events. Follow-up (12May2021): Follow-up attempts completed. No further information expected.

First vaccine 2/18/21, raised rashinner arms, arm pits, body sides,stomach inner thighs. After seconddose moved to upper thighs and back; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Feb2021 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6199) via an unspecified route of administration in the left arm on 11Mar2021 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis. The patient had no known allergies. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN) for unknown indications and duration. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced rash on the inner arms, arm pits, body sides, stomach inner thighs after receiving the first dose. On 23Feb2021, the patient experienced rash on the upper thighs and back. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received first steroid shot and on 29Mar2021, the patient had taken prednisone p (MANUFACTURER UNKNOWN) as a treatment for the adverse event. The clinical outcome of the events generalized rash was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Skin started itching everywhere; Skin started feeling sunburned everywhere; Some little raised bumps on his stomach like a little area of that itched/On his stomach he had the little welts that started to itch; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 11:00 (at the age of 78 years old) (Batch/Lot Number: EN6201; Expiration Date: Jun2021) as single dose for COVID-19 immunisation. Medical history included allergies. The patient's concomitant medications were not reported. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jan2021 (Batch/Lot Number: EL3249; Expiration Date: Jun2021) as single dose for COVID-19 immunisation and experienced itching all over his body. States he took Benadryl regularly for the side effects but after 4-5 hours of taking the Benadryl, his symptoms returned. After a few days the itchiness resolved. States he went to allergist and received a prescription for prednisone, epipen and Benadryl with instructions for use by allergist. He was instructed to take Benadryl prior to the 2nd shot of the vaccine. He was instructed to take Benadryl if reaction post vaccine shot was mild and instructed to use epipen and call if he had a bad reaction. Also instructed to take Prednisone if Benadryl was not working. Received his second vaccine shot yesterday and, in the afternoon, developed a sun burning sensation on his skin in addition to itchiness and a welt on his stomach. The patient took Benadryl and within 30 mins symptoms resolved. He had had to take Benadryl regularly (every 4-5 hours) as his symptoms returned about 4 hours after a dose of Benadryl. States he has not needed the epipen or prednisone and would like to know if Benadryl deactivates effectiveness of vaccine. The patient wanted Pfizer to conduct clinical trials/have information on how antihistamines may interfere with the vaccine and asked if there is a blood test he can take after a period after the second vaccine dose to determine effectiveness of the vaccine. Concerned about his reaction as wondering if he should avoid the vaccine if a booster is indicated down the road and especially if his reaction is consider serious reactions and asked about the half-life. This consumer called to ask if Benadryl he has taken would affect the efficacy of the Pfizer COVID-19 Vaccine that he has been administered. He has allergies so he took a Benadryl approximately 2 hours before being administered the vaccine around 11:00. After second dose was administered, he felt ok, he waited on site for about 30 minutes for monitoring like you are supposed to. About 2 hours after vaccine was administered his skin started feeling sunburned everywhere and skin started itching everywhere. In response to events he took another Benadryl. About 30 minutes after taking Benadryl the events went away. About 4-5 hours later the events came back the same way as when they started. He had some little raised bumps on his stomach like a little area of that that itched. His body itched all over but it felt horrible sunburned. He took another Benadryl and in about 30 minutes the events kind of cleared up, it was good. About 4 hours after that the Benadryl wore off, the events came back so he took another Benadryl. Today the events are ongoing but a lot milder than it was on 17Feb2021. It seemed like every 4-5 hours the events would come back but milder today. His question is since he had to take Benadryl or he would have been itching all over the place; and he did not want to go to emergency room which he probably would have had to if he had not taken the Benadryl; and he would like an answer, not a maybe; since he had to take Benadryl and taken Benadryl again today and got the Pfizer COVID-19 Vaccine shot yesterday, is the Benadryl counteracting the efficacy of the Pfizer COVID-19 Vaccine. He has had no other vaccines or immunizations other than the first dose of Pfizer COVID-19 Vaccine. He took Benadryl pill 2 hours before he went for the second dose of Pfizer COVID-19 Vaccine; had the second dose of Pfizer COVID-19 Vaccine shot, nothing happened until he would say maybe around 13:00; because he waited 30 minutes after the shot; got in the car and came home. Around 13:00 he started getting the itchiness but this time his skin felt like it was sunburned everywhere. He was not out in the sun, it is snowing there, there are clouds, no sun; skin all over felt like it was sunburned. On his stomach he had the little welts that started to itch; He took Benadryl. He did not want to use the Epi-Pen because the allergist said he had to call # if he used the Epi-Pen and he did not want to do that. Benadryl cleared it up; did not make it go away; about 4 hours later events started back; so he took Benadryl again; and about 4 hours later events came right back; it did that all night. Today, right now, he took a Benadryl let's say about 4-5 hours ago and events are not coming back like that. If events do not come back, he probably won't take another Benadryl. Events are a lot milder now, seems like they are going away. The Benadryl works. His concern is because he did hear on TV from one of those TV doctors on one of those daily regular daily talk shows that his idea was, and caller reported it is unknown how accurate the information is; but the doctor said avoid taking medications like Aspirin, Tylenol or antihistamines, all that stuff when you get your shot because it could affect the efficacy of the shot. Caller is not sure he is right; because his allergist just said take the Benadryl in case of anaphylactic shock which he did not have. Would like to know if this a waste of all this stuff he did because what they did now was he interfered with the action of the vaccine. No other vaccines were administered on same date with the Pfizer vaccine considered as suspect. The adverse events required visit to Physician office and not required to visit Emergency room and was not hospitalized. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering. No follow up attempts are possible. No further information is expected.

experiencing in his left arm where the bump is a sensation of being red/ redness, heat and itching are in the location of the injection; redness, heat and itching are in the location of the injection/ feels hot; intermittent itchiness/ redness, heat and itching are in the location of the injection; it was just sort of like rash; it's a delayed allergic reaction; I have only minor discomfort; Pfizer Covid-19 vaccine that was given at an angle and a bump occurred; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL0261; NDC number, UPC number and expiry date: unknown) via an unspecified route of administration in left arm on 05Feb2021 (age at the time of vaccination was 78-year-old) as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure and epilepsy both from an unknown date and unknown if ongoing. The patient had low level of sodium in his system because of phenobarbital. The patient's wife had metaplastic breast cancer and passed away 12 years ago. The patient's concomitant medications included phenobarbital; phenytoin (DILANTIN [PHENYTOIN]); riboflavin (VITAMIN B 2); cyanocobalamin (VITAMIN B 12 [CYANOCOBALAMIN]); vitamin D3; vitamin C [ascorbic acid]; tocopherol (VITAMIN E [TOCOPHEROL]); colecalciferol (VITAMIN D [COLECALCIFEROL]); calcium; ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) all taken for an unspecified indication, start and stop date were not reported. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176; NDC number and expiry date: not reported) on 15Jan2021 for COVID-19 immunization and experienced dizziness, headache and chest discomfort. The patient received second dose and reported that the injection was given at an angle and then there was bulb (bump) on his arm for 4 months. In Jul2021, the patient had feeling of sensation in his arm, feeling of the thing red, felt hot and had inter massive itchiness. The patient reported that the redness, heat and itching were in the location of the injection (area was in the upper portion of his left arm, almost by his shoulder). At first, the patient didn't really give it much attention because it was just sort of like rash and then it started becoming little bit attended and becoming little bit like heat there, the patient had no fever at all during the whole period. He had only minor discomfort and itching. The patient asked if anyone had experienced the sides effects which the patient felt at the injection site (feeling hot and intermittent itchiness). The events were reported as non-serious. The patient found an article on news entitled rare COVID arm phenomenon, a harmless immune response to vaccination, and the patient said that the article was talking about COVID arm, about where in 1st trial 344 people had the COVID arm but in the 2nd trial 64 people had COVID arm but this was the late body reaction that initially occur 10 to 14 days after the injection. The patient got 4 rounds of house treatment. The patient had been to safety and medical information. The patient had an article that he found online that covers all the symptoms that he had, that indicates that it was a delayed allergic reaction and that was the minor incidence and its extremely rare even on the global level. The patient reported that it occurred within the company Moderna, the other vaccine company like Pfizer that produced the 1st 2 vaccine. It was kind of same technology that they use, and the indication was that it will go away if an individual basically takes an aspirin or some anti-inflammatory for a few days. The patient was concerned about it because the way the owner of report said that the initial allergic reaction occurs with people within 10 to 14 days, the patient was 4 months after the effect and had symptoms. The patient explained the way he received injection. The patient reported that they may have given him the vaccine at an angle which created a small pocket through the medicine to stay into regional muscle and later it was released into his system and the patient experienced side effect, that was the minor side effect by description and he had an article that he can refer and even had a quotation medical journal of medicine, what they called a COVID arm phenomenon. The patient gave the reference of the website to other two ladies, where the rare phenomenon called the Covid arm was listed in detail. The patient further stated left upper right arm almost at the shoulder level. The patient did not receive any treatment medication. Investigations was not reported. The outcome of all the events was unknown.

shingles left chest painful maculopapular labs with elevated igg and igm vzv still painful lesions still present no crusting or weeping no past hx of shingles vaccine

Rash is itching; rash under his arms from armpit to elbows underneath and on his sides below his belly button and in the groin area and on his buttocks; This is a spontaneous report from a contactable consumer (patient's wife). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at the right arm on 02Jan2021 00:45 at a single dose for COVID-19 immunization. Medical history included hard of hearing, surgery to remove the cancer, cancer broke his arm and he had a reverse shoulder replacement (medical conditions predating treatment with Pfizer COVID 19 vaccination); kidney failure that is better, muscle (disorder), blood pressure (abnormal), anxiety and radiation. The patient was previously given oxycodone, Ativan, and Xanax to take as needed after his surgery, but he has not taken them since Oct2020. Concomitant medication included sertraline hydrochloride (ZOLOFT) for anxiety, amlodipine for blood pressure, metoprolol for blood pressure, tamsulosin hydrochloride (FLOMAX) from Sep2020 for kidney, carisoprodol (SOMA) from 22Oct2020 for muscle relaxant, ferrous sulfate, docusate sodium (STOOL SOFTENER), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) all were ongoing and other unspecified products. The reporter stated that she and her husband got the vaccine on 02Jan2021 and the husband has developed a rash under his arm from his arm pit to elbow underneath, on his sides, below his belly button and in the groin area and on the buttocks. Rash was itching on 06Jan2021. She wanted to know could the COVID 19 vaccine cause this 4 days later. The patient noticed the itchy rash four days later on Wednesday afternoon 06Jan2021. He took Benadryl 25mg tablet by mouth that night before bed and then in the morning and put over the counter itch relief cream on it so in the night around 0200AM not too long after taking the Benadryl, the rash went away, pretty much gone. Today it seems to have come back and now it was worse because he has it on his buttocks. He didn't have it there at first. Mentioned that the patient also took a cool shower before going to bed. Wife mentioned that she just looked the rash right now and it was improved. Asking should he continue taking his relief or stop and let the doctor look at it? Advised caller to consult HCP. He is planning to get the next vaccine 23Jan2021. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The events did not require a visit to physician office and ER. No prior vaccinations (within 4 weeks). No relevant family medical history. No relevant tests done. Outcome of the events was recovering. Information on the Lot/Batch number has been requested.

head rush Narrative: Patient provided juice/water, cleared by monitoring staff to leave vaccination clinic

Injection received in left arm (shoulder) - a sore has developed near his arm pit about the size of a dime. It has a scab and is red.

Small bruise appeared one day after injection, expanding to 3/4 inch diameter over several days and to 2 inch diameter after 6 days.

Development of rash that started on the right side of the face starting about 4 hours after the injection,, then spread over the next 24 hours to the trunk and extremities. Most florid and confluent on the face. Minimal itching. No other systemic symptoms. Feels well otherwise.

Rash starting on the right side of the face, spreading onto the trunk and then onto the extremities. Rash is confluent on the face, less intense in other areas, not very itchy. Feels well otherwise.

experiencing some arm pain where the injection was given; This was supposed to be under 70 Degrees Fahrenheit. They were keeping it out side and giving the injection; This was supposed to be under 70 Degrees Fahrenheit. They were keeping it out side and giving the injection; This is a spontaneous report from a contactable consumer (consumer). A 79-year-old male patient received first dose of BNT162B2 (lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose in the arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. This patient reports receiving his first injection of the Pfizer-BioNTech COVID-19 vaccine and experiencing some arm pain where the injection was given. Also he just noticed that when the nurse was going to give it to him that she had the syringe with the vaccine in it in her hand. She talked to him several minutes before administering. He thought this was supposed to be under 70 Degrees Fahrenheit. They were keeping it outside and giving the injection. He doesn't understand why they had it out in the weather. It was kind of warm in the state. The outcome of the events was unknown. Information on the lot/batch number has been requested.

On 1/29/21, patient started to feel soreness of left side of toro. On 2/4/21, patient started to see rash of painful area. On 2/7/21, pt came to Urgent Care for evaluation, diagnosed with shingles, and prescribed valacyclovir 1g, one tablet by mouth every 8 hr for 7 days. Patient has history of shingles in 1984. Patient has never have COVID19 illness.

REPORT GIVEN BY HIS WIFE. DAY ONE: ITCHING IN ODD AREAS OF BODY (UNDER ARMS AND BACKSIDE). NEXT DAY FEELING TIRED. FRIDAY HE DID FEEL WELL AND O2 LEVEL 91% - 88% THEN A RASH WAS NOTED FROM NECK DOWN TO LEGS. WIFE TOOK HIM TO THE HOSPITAL SATURDAY MORNING. IN ER FOR ALLERGICE REACTION, BUT THEN TOOK A TURN FOR THE WORSE AND WAS PLACED ON BI PAP MACHINE FOR ABOUT 5 HOURS. DISCHARGED AFTER 5 DAYS IN HOSPITAL. ALLERGIST CALLED I N TO CONSULT-

The normal site pain from the needle stab, and several minutes later a sympathetic pain in the right shoulder. Sounds crazy, but the same thing happened to my sister and one of her friends. Sometime later after arriving home, I developed chills. At 10:30 pm I took two extra strength acetaminophen capsules (500 mg, ea.). That eliminated both the chill and the right shoulder pain by 11:30. Today, the 18th, I am feeling fine except for the injection site pain.

Red rash on bilateral cheeks with onset date 2/1/2021. Macules of 3/8 inch. Redness of skin on left forearm best described as macules at sites of previous skin burns or scrapes, with onset date of 02/05/2021. Treated with topical hydrocortisone . Resolved by 2/19/2021.

On February 18 or 19, noticed a 5 mm. purpuric skin lesion on right hand, not painful. On about February 19, perhaps in the evening, noted varied perhaps 5 mm discolorations on ankles that in retrospect were probably resolved mild purpuric lesions. On the same evening, noted very mild tenderness in the calf (soleus muscle) regions bilaterally feeling like mild muscle fatigue. On February 21 at about 6 AM, before showering, noted bright cherry red lesions on/under skin of both ankles and more severely on the posterior calf of both lower legs above the calf tenderness. The skin was flat and not tender. Calf tenderness was slightly worse (though still mild). Lesions turned purpuric, fading in hours.

A 4 inch red rash appeared on 2/13/21. continued both sides of arm to elbow and then inside of arm above wrist by 2/20/21. disappeared by 2/24/21.

rash worsened; compromised immune system with the Multiple Myeloma/ getting the COVID-19 Vaccine; compromised immune system with the Multiple Myeloma/ getting the COVID-19 Vaccine; This is a spontaneous report from a contactable nurse for her husband. A 79-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration at left arm on 26Jan2021 06:00 at single dose for covid-19 immunisation. Medical history included plasma cell myeloma from Oct2018, a compromised immune system with the Multiple Myeloma, rash from Dec2020 and ongoing. The patient had a diagnosis of multiple myeloma and had developed a slight rash on his left arm to lenalidomide (REVLIMID) before receiving the COVID vaccine, Benadryl was taken and after 3 days, it was gone. It was only on his upper arms. She said a rash was a known side effect of the lenalidomide. The nurse giving his vaccine shot noticed his slight rash on his left arm. Concomitant medication included lenalidomide (REVLIMID) for 2.5 years for multiple myeloma in remission. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The past drug included bortezomib (VELCADE), the patient was administered a chemo agent (bortezomib) at the oncology center every 2 weeks and the oncology center held off giving his chemo shot 2 weeks before he received his first COVID-19 Vaccine on 26Jan2021. The reporter said her husband would not restart the chemo shot until he sees his oncologist again. She clarified her husband has now been off the bortezomib for a month, as of 01Feb2021. The patient experienced rash worsened on 28Jan2021. By 28Jan2021 the rash had spread to his trunk and by 29Jan2021 to his back. She clarified his rash was a dry rash, with no blisters or oozing. Her first thought was to get an ointment or a spray. He has now been given prednisone instead of a dose pack and the rash was gone/ the rash cleared up almost immediately and will stop lenalidomide for a couple weeks and continue the round of prednisone. The doctor could alter his therapy as needed. On 04Feb2021, the rash was gone but her husband's doctor wants him to finish his prescribed course of Prednisone. She clarified the Prednisone (manufacturer: Actavis) 40 mg was started on 01Feb2021, the rash started fading fast. By the next day (Tuesday, 02Feb2021) the rash was really fading, and now (04Feb2021) the rash was totally not there. The doctor told her husband to take one Benadryl, and to continue taking the Benadryl if his rash itches. She said her husband's latest blood work didn't indicate anything. She said her husband's labs were always off, but were normal for having Multiple Myeloma. Both doctors want to keep her husband off of the lenalidomide. Reporter seriousness was reported as medically significant . The patient was treated for Multiple Myeloma for the past 2-1/2 years. He had been doing well, and his cancer doctors approved of him getting the COVID-19 Vaccine. The oncologist wanted her to call Pfizer to see if she can find anything about the COVID-19 Vaccine and how it pertains to the lenalidomide and her husband's Multiple Myeloma. She said her husband was almost 80 years old and very active. She said her husband had been in remission Multiple Myeloma for a year and his blood work was fine. By the time her husband starts taking lenalidomide again, he would be off of lenalidomide for almost 4 weeks. She said her husband's oncologist said he was going to cut back her husband's lenalidomide milligram dose and change his lenalidomide frequency to every other day when he resumes the lenalidomide. The reporter checked her husband's blood pressure (130/76) on 29Jan2021, after his rash worsened. She saidnot require a visit to emergency room or physician office. The rash event outcome his pulse was fine, and she tested his blood sugar and it was fine. She said he had no temperature, clarifying his temperature was 97.6. The event did was recovering. The drug result was reported as unrelated. The reporter and her husband's doctors don't think his rash has anything to do with the COVID-19 Vaccine. The patient asked if Pfizer can point her in any direction with regard to her husband's situation. She said she read the COVID-19 Vaccine is a dead virus, but wants to know if her husband should be cautious in getting the second COVID-19 Vaccine dose. She said her husband's doctors know that the rash was not precipitated by the COVID-19 Vaccine, but his rash did get worse after he got the first COVID-19 Vaccine dose. His second dose was due 16Feb2021. The reporter was wondering if she should delay the second dose of the vaccine, the vaccine would make the rash worse.; Sender's Comments: Based on the information currently provided, the rash worsened after 2 days following the vaccine use thus a contributory role of BNT162B2 might not be fully excluded towards the event onset. Severe allergic reaction is the known risk for the product and Rash faded soon under Prednisone. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate

a little bit of itching; kind of hives; uncomfortable at times, at his feet, and ankles; he has rashes; terrible skin; This is a spontaneous report from a contactable consumer (reporting for himself). A 79-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: unknown), via an unspecified route of administration from 09Jan2021 to 09Jan2021 at single dose for COVID-19 immunization. The patient's medical history Ablation surgery. The patient's concomitant medications were not reported. On an unspecified date, the patient had a little bit of itching, kind of hives, he did not break out, he was uncomfortable at times, at his feet, and ankles. The patient has rashes, and terrible skin. The outcome of the events was unknown.

welts and rash on back and chest with second shot; welts and rash on back and chest with second shot; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265, expiration date: May2021), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunisation. Medical history included ablation surgery from an unknown date about two to three months ago. The patient's concomitant medications include an unspecified blood pressure medicine. The patient previously received the first dose of BNT162B2 (lot number: EL3248, expiration date: Apr2021) on 09Jan2021 for COVID-19 immunization and experienced had a little bit of itching, kind of hives, uncomfortable at times, has rashes, terrible skin. On 30Jan2021, Saturday evening, it was reported that the patient experienced welts and rash on back and chest with second shot and were probably worse on Sunday, he doesn't know if it is better today or not, perhaps it is a little better. The outcome of the events was recovering.

not been feeling well at all; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL9262, expiry date unknown), via an unspecified route of administration at the left arm on 29Jan2021 13:15 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he had an injection site pain on 29Jan2021. It was still sore after 3 days and the day afterwards he was not been feeling well at all on 30Jan2021. He was not sure if it has any effect on it, but had a pacemaker put on the right side of his chest in a week before getting the shot so he was not sure if that could affect how he was feeling. The outcome of the event 'injection site pain' was not recovered and the outcome of the event 'not been feeling well at all' was recovering. The vaccination facility type was hospital. The vaccine was not administered at the military facility.

Pain developed in right arm at injection site. Pain very slowly diminished for 10 days. First day temperature of 101.3F. Very debilitating, making it difficult to dress and to sleep. Hand to take anti anxiety drugs to help sleep for 8 days. I had COVID -19 and was hospitalized from Nov.16 to Dec. 4 2020. Then 2 weeks in bed before able to walk downstairs. Not a pleasant experience!

2nd Pfizer Covid-19 vaccine received by patient on 2/24/2021 & patient developed a rash on his right shoulder on 2/25/2021. Rash remains present & has spread to lower chest, so patient completed a virtual visit with PCP's office today, 3/11/2021. Patient reports blisters when rash initially started; patient denies fever, chills, pain at this time. PCP notes that scabs have developed & rash has spread to lower chest. PCP states 'Do not recommend medications at this time given time of rash course & no new lesions present. Tylenol for pain. Advised that rash should resolve after a month.'

He was itching behind both ears and now it is in the crack of his butt and on his butt cheeks; It is big, welty, and red; It is big, welty, and red; Rash was reported as worsened.; Rash; This is a spontaneous report from a contactable consumer or other non hcp. A 79-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, lot #: EL3302), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EL3302) as SINGLE DOSE for covid-19 immunisation. Medical history included gingival disorder from an unknown date and unknown if ongoing. Concomitant medications included doxycycline hyclate (DOXYCYCLINE HYCLATE), chlorhexidine gluconate (CHLORHEXIDINE GLUCONATE) taken for gingival disorder from 21Jan2021 to 06Feb2021. On 06Feb2021, the patient experienced rash, on an unspecified date he was itching behind both ears and now it is in the crack of his butt and on his butt cheeks, it is big, welty, and red, rash was reported as worsened. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of he was itching behind both ears and now it is in the crack of his butt and on his butt cheeks (pruritus). The outcome of the events was not recovered. The outcome of the event rash was reported as worsened was unknown.

3-7-21 spouse first noticed red spots on face by spouse; also bloody nose later; pt stated that two weeks prior (2-21-21) patient noticed spots on L leg (calf) and assumed it was a rash. Saw PCP on 3-8-21 at health clinic who dx petechiae and ordered a blood draw. Repeated blood draw 3-9-21. Transported via car to ER 3-10-21 and later tranferred where he was treated by hematologist. Patient dropped to 0 platelets

On 03/11/2021 pt noticed a red rash, itchy, spots from knees down to ankle. Pt applied Aveeno lotion to effected areas, which provided some symptom relief. The redness and itchiness are going away slowly and the skin is returning to normal color. 3/22-Red rash, itchy, spots from knees down to ankle- Started 03/11/2021- Diminishing but still present

79 y/o males with hx Parkinson's Dz and prostate CA received 2nd Pfizer dose 3/20/2021. Client had no adverse reactions to dose 1 of Pfizer. Several days after 2nd dose client noticed injections site on right arm was itching, red in color and warm to touch. 3/26/2021 went to urgent care and received steroid for reaction. Client is experiencing no pain, just itching and redness at injection site. Client was instructed to report reaction to DOH.

I am not sure that this is a result of the vaccine but I have been diagnosed with shingles and I did take the shingles vaccine in 2014 and was waiting the required two weeks to take the shingrix vaccine when I started to have issues that made me think I might have shingles. I had cataract surgery on my left eye on March 17 but I don't think that had any bearing on me getting shingles. I have heard that others have developed shingles after being vaccinated for covid-19. That is only hear say and i have no direct information about that, So far my case of shingles is moderate.

Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; night sweats; under left armpit tenderness; enlarged swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM6201), via an unspecified route of administration at arm left on 05Mar2021 02:00 pm at SINGLE DOSE for covid-19 immunisation. Medical history included heart bypass. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) at the age of 79-years-old, via an unspecified route of administration at arm left on 12Feb2021 02:00 pm at SINGLE DOSE for covid-19 immunisation. The patient experienced cellulitis and red hot swelling upper arm and lower arm, also night sweats, under left armpit tenderness and enlarged swollen lymph nodes, all on 12Mar2021 10:00 pm. Treatment with prescription of Bactrim DS 2x daily 160 mg & Tylenol. Events outcome was recovering. No covid prior vaccination. No covid tested post vaccination.

sore arm; injection site pain; extreme fatigue/Exhaustion; a little headache; chills; muscle pains which makes them a little achy overall; sleepy; feel like they have Covid all over again; feel achy; feel lousy; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248) via intramuscular in left arm on 28Jan2021 at single dose for COVID-19 vaccination. The patient medical history included Covid. Concomitant medications were not reported. On 29Jan2021 the patient was experiencing a sore arm, injection site pain, extreme fatigue, a little headache, chills, and muscle pains which makes them a little achy overall. It was reported that she and her husband both received the vaccine yesterday and stated that they feel like they have Covid all over again on 29Jan2021. She stated that they had Covid already and stated that they have chills and are achy 29Jan2021. Caller said that they are also having that Covid exhaustion. Their arms were quite sore too from the shot, but they did not expect to feel lousy on 29Jan2021. They have been sleepy all afternoon and stated that they sat down and just passed out, caller clarified that they went to sleep on 29Jan2021. Yesterday they were ok. The outcome of the events sore arm, injection site pain, a little headache was unknown, extreme fatigue/exhaustion, muscle pains which makes them a little achy overall, sleepy, feel like they have Covid all over again, feel achy, feel lousy was recovering, chills was resolved on 29Jan2021. No follow-up attempts are possible. No further information is expected.

urticarial type rash on the left side of anterior torso and left arm. mildly itchy. mild irritability.

Three days after the second Pfizer shot I had high temperature, sore throat, breaking out on the skin on the neck and face, hands, which has lasted for the past nine days

Developed shingles. While correlation doesn't mean causation I'm suspicious that COVID vaccine work on immune system and shingles crops up when that immune system fails to suppress the chicken pox vaccine.

He had his second shot and had rashes that have come out on his thighs and his wife said, he had them on his, just above his waistline and on his right shoulder blade; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Feb2021 (at the age of 79-years-old) (Batch/Lot Number: EL9262; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism taking levothyroxine. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for hypothyroidism, start and stop date were not reported. The patient previously took bnt162b2 (BNT162B2), dose 1 on 22Jan2021 (at the age of 79-years-old) (Batch/Lot Number: EK9231; Expiration Date: 30Apr2021) as SINGLE DOSE for covid-19 immunisation. Consumer stated, he was not sure but he thought he had a reaction to the Covid shot. He had his second shot and had rashes that have come out on his thighs and his wife said, he had them on his, just above his waistline and on his right shoulder blade and they were approximately of a size of a dime and they were pink but they were not raised and they donot itch. The patient did not receive any treatment for the event. Outcome of the event was unknown.

He reported that he had puffiness around his lips and he was itching like crazy; itchiness; This is a spontaneous report from a contactable consumer or other non hcp. A 79-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: EN4809) as SINGLE DOSE for covid-19 immunisation. Medical history included surgery (three or four years ago) and gastrooesophageal reflux disease. Concomitant medication(s) included metformin; metoprolol; acetylsalicylic acid (BABY ASPIRIN); amlodipine; rosuvastatin; ezetimibe; famotidine (PEPCID [FAMOTIDINE]) for gastrooesophageal reflux disease; irbesartan and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient reported, he received his first shot of the Pfizer BioNTech COVID-19 vaccine on 04Feb2021 and is scheduled to receive his second on 22Feb2021. States that after his first dose, he experienced puffiness around his lip and itching like crazy with scratching his forehead, scalp, and shoulder. He hasn't experienced these symptoms for the last 4-5 days and reports it wasn't nasty. It doesn't last long. It has been tolerable. He remembers when he got the Shingles shot he had some itchiness. At the end of this week, he has to get the second shot. The outcome of event Lip swelling was recovered and for itchiness it was unknown on 06Feb2021.

pain at injection site; This is a spontaneous report from a contactable consumer. A 78-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EC9267, Expiration date: unknown) via an unspecified route of administration on 27Feb2021 13:30 on left arm at single dose for COVID-19 Immunization. The patient's medical history included Multiple Sclerosis and allergies to Solumedrol. 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 vaccination, patient had not tested for COVID-19. Patient received too many lists of medications in two weeks (not specified). On 27Feb2021 13:45, Patient experienced pain at injection site. Patient did not receive any treatment for the event. The outcome for the event was recovering. No follow-up attempts are needed. No further information is expected

Long distance vision slightly blurred for 3 days.; Hands were slightly red for two days; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received fist dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9261), via an unspecified route of administration in left arm on 08Feb2021 at 15:45) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced long distance vision slightly blurred for 3 days on 09Feb2021. Now fine. Hands were slightly red for two days on 09Feb2021. Now fine. Both me and my wife hands were red for the same time. No treatment received for the reported events. The outcome of the events was resolved on an unspecified 2021.

* 4/9/2021: Father in law went to get blood drawn for his INR (before 10am) * 4/9/2021: He started seeing some spots develop on his back. he did not tell anyone * 4/12/2021: Spots spread on his back. He told my mother in law. My sister in law took him to an urgent care. They ran blood and said results would take 3-4 days *4/16/2021: Urgent care said results could take two weeks. My sister in law took him to the medical center. They diagnosed shingles but also said his heart rate was low. My father in law was talking in circles/not making sense/acting confused so they ran the EKG to check pacemaker * 4/16/2021: Heart rate stabilised and they discharged with topical treatment for his shingles

rash; This is a spontaneous report from a contactable consumer. A 79-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 (Batch/Lot Number: el9269) as SINGLE DOSE for covid-19 immunization. The medical history of patient included vascular disease, chronic lymphocytic leukemia, squamous cell. The concomitant medications included Atorvastatin, Metoprolol, multivitamin, low dose As. The patient previously took amoxicillin and experienced drug hypersensitivity, doxycycline and experienced drug hypersensitivity. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/LOT no el3294) dose 1 on 20Jan2021 at 10:30 via an unknown route of administration in left arm as single dose for COVID-19 immunisation. On 13Feb2021, the patient had rash that appeared about 4 inches in diameter and continued to enlarge around arm above elbow and on the inside of arm down to watch band through 20Feb2021. Patient did not receive any treatment. Patient did not have covid prior vaccination. Patient did not have covid tested post vaccination. The outcome of the event was recovered on 24Feb2021.

chest pains; cough; rash; This is a spontaneous report from contactable consumer (patient) via Medical information Team. A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 22Jan2021 at 14:15 (Lot Number: EL3248) as single dose; dose 2 via an unspecified route of administration, administered in right arm on 12Feb2021 at 14:30 (Lot Number: EN6201) at the age of 79 years as single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Mar2021 the patient experienced chest pains, and cough, which required hospitalization from 05Mar2021 to 08Mar2021. The patient informed that he had some stress with son and daughter to point where he had some chest pains. After a week or two of conversation involving patients son and granddaughter culminated into this. The patient informed that when he went to the hospital because of chest pains, patient was already use to that and wasn't worried about it. The patient stated he didn't want to go to the hospital, called the doctor but because of Covid, the doctor wouldn't see the patient. The patient stated he shouldn't have been in the hospital at all. In terms of the cough, he simply called the doctor because the patient wanted cough medicine or something for that, temporary thing coming on. Patient stated the cough did not linger, and it was never treated. The hospital got into the chest pain and jumped on the heart situation and patient thinks they saw dollar signs or something. The patient wasn't very happy with them. The patient informed that he was given a blood thinner, Heparin IV during time hospitalized. The hospital decided to hold the patient over and they gave the patient Heparin IV for a good part of three days. The patient reported that he was discharged on 08Mar2021, and on 10Mar2021 the patient noticed the rash. The patient reporting experiencing rash after receiving both doses of the Pfizer covid-19 vaccine. The patient was thinking the combination of Plavix and heparin only three weeks after having the Pfizer Covid Vaccine could possibly be a side effect of rash. Therapeutic measures were taken as a result of rash. The doctor gave the patient Clobetasol Propionate and patient did treat rash with that. The doctor said to apply for 2 weeks and come in on one week. It has already improved. The patient mentions that he was also taking Calamine lotion and some spray and they all seem to be working. Patient didn't want to keep taking Clobetasol because it is a steroid and he had been using for a month and didn't want to do that. The clinical outcome of rash was recovering. The clinical outcome of the remaining events was unknown.

injection site soreness; This is a spontaneous report from a contactable consumer. A 79-years-old male patient received BNT162B2 (COMIRNATY, formulation solution for injection) via an unspecified route of administration on 27Jan2021 20:30 (Batch/Lot number: Unknown) as single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. It was reported that no underlying Heath conditions. Patient in good overall health. On 28Jan2021 8:00 the patient experienced injection site soreness. The event was considered as non-serious by reporter. The outcome of event was unknown. The action taken in response to the event for bnt162b2 was not applicable. Information on the lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Two weeks and one day after receiving second dose of COVID19 vaccine, patient experienced extreme sharp pain in injection arm (left arm: injection site, shoulder and elbow) as well as muscle in opposite leg and hip that prevented him from walking. Pain has minimized since then (report is one week after incident) but patient still feels some minor pain, and says he will report to his primary care provider if symptoms persist for one week. Patient took aspirin for pain, which helped.

I had a full on body rash, started slowly the night I received the first dose. Spread from my back, to the rest of my body and lasted for two months. Two or three hours after the injection, I had issues walking on my left leg for about 6 or 8 hours.

Loss of breath, unable to stand, loss of memory, oxygen level became low, dizzy, weakness, blood pressure declined, diarrhea, vomiting, injection sight swollen, disoriented, shakes, was freezing, uncontrollable bowls, unknown substance coming from mouth, loss of strength in arm

Extreme muscle pain over entire body; Headache; Skin pain; Chills; Sweat; Hard to keep my balance; This is a spontaneous report from a contactable consumer, patient. A 79-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on unknown date (at the age of 79-year-old) as a single dose for COVID-19 immunization. Medical history included blood pressure high. The patient had known allergy with sulfa drugs. The patient taken other medications (unspecified) within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced extreme muscle pain over entire body, headache, skin pain, chills, sweat, hard to keep his balance on 15Mar2021 at 23:00. Therapeutic measures included treatment with high doses of Tylenol. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme muscle pain over entire body, headache, skin pain, chills, sweat, hard to keep his balance was recovered on an unknown date. Information about lot/ batch number cannot be obtained. No further information is expected.

Started breaking out with eczema; This is a spontaneous report from a contactable consumer (patient himself). A 79-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6206; expiration date was not reported), via unspecified route of administration, in the left arm, on 10Mar2021 at 10:00 (at the age of 79-year-old), as single dose for COVID-19 immunization. The patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications included ongoing allopurinol (strength: 150mg) for gout from unspecified date, taken it for 2 or 3 years and also reported other unspecified concomitant products. The patient's historical vaccine included first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number: EN9809; expiration date was not reported), via unspecified route of administration, in the left arm, on 19Feb2021 (at the age of 79-year-old), as single dose for COVID-19 immunization. Patient got both shots of the COVID Vaccine in mid Mar2021, and he had no side effects and was doing good. About a month later, and he has never had it, he started breaking out with eczema in at the beginning of May2021 at late afternoon. He also went to a dermatologist. Patient had an appointment on 18May2021. When asked if it had improved, was persisting, or had worsened, he states it was not serious and was breaking out in little patches here and there. The dermatologist gave him a steroid cream. No additional vaccines administered on same date of the Pfizer Suspect. Patient did not receive any prior vaccinations within 4 weeks. Patient did not receive any emergency room and physician office visit for eczema. Outcome of the event was unknown.

her husband received one injection to his left arm and his arm was black and blue; Periodic episodes of feeling itchy/itching to his back, abdomen, some to the upper parts of his legs/thigh area and had a little bit to his head clarified to being his scalp; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This report refers to the husband. An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246, expiry date: 30Apr2021, NDC number of Pfizer COVID-19 vaccine: 59267- 1000-2), via an unspecified route of administration on 06Jan2021 18:00 at single dose in the left arm for COVID-19 vaccination. Medical history included joint surgery which he just had one at the end of December of last year (2020) and had a procedure in Sep (unknown year); and prostate cancer which he had surgery February last year for this. The patient's concomitant medications were not reported. The nurse (patient's wife) reported that the patient received the Covid -19 Vaccine around 6 o'clock on Wednesday evening. So basically 2 days ago and neither one of them seem to show any major reaction but yesterday sometime during the day, he started noticing a little bit of itching in his abdominal area and his back, no sign of whatsoever of a rash, there is no evidence of a rash at all but it is bothering him off and on today and she just didn't notice that was related in anyway. It's not in any of the paperwork we received and it's no rash and he is not having trouble breathing anything like that but he is having these periodic episodes of feeling itchy. When paraphrased the above concern, nurse stated, "That's right, the back, basically yes and no other area right across the abdominal area and some occasionally little bit on his leg but more often on his back and it is not constant and there is no visible rash and he doesn't have a history of drug allergies. He is not one who generally reacts and he has no temperature, his vital signs are good. They just wanted to know if something we should be concerned about or whether there is been any report of this, she asked if they should call the doctor or what should they do. On 12Jan2021, the nurse called again and she stated that on 07Jan2021 (Thursday), the patient experienced random itching and continued in to Friday. Furthermore, she stated that the day after he got the shot, and he is 80 with no history of drug reactions he had itching to his back, abdomen, some to the upper parts of his legs/thigh area and had a little bit to his head clarified to being his scalp. She says that she went to the drug store and got him some Benadryl. She says her the itching went away then on Thursday, and the next day he works part time, so he went to work on Friday and it started again. He was better on Saturday. She would like to know if this is a possible side effect, or if there might be a problem with him getting second dose. She said that the itching was in random places, it was the second night that she gave him the Benadryl that knocked him out, clarified he was sleepy after taking the Benadryl. She says she never saw a rash on his skin, and Saturday the itching was mitigated considerably. She said on Friday night she had got a little nervous, since the patient is 80 and has some health issues but no issues with medications in the past to their knowledge. He was better the next day. She says she doesn't know if his itching was associated with the vaccine. Also reported that the patient received one injection to his left arm and his arm was black and blue afterwards. The outcome of the event "Periodic episodes of feeling itchy/itching to his back, abdomen, some to the upper parts of his legs/thigh area and had a little bit to his head clarified to being his scalp" was recovered on 09Jan2021; for event "her husband received one injection to his left arm and his arm was black and blue" was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021028800 same reporter/drug, different event

Red area on the left side under the arm pit severe burn like a hot iron stating to heal 01/20/2021 pealing

Patient's wife called this morning stating that her husband has passed away last night. After receiving first dose of Pfizer COVID-19 vaccine at around 0830, patient remained in the Immunizations Department for the 15-minute monitoring period. Per wife, patient's only complaint was pain at the injection site. At 1300, wife states that patient complaint of dizziness which "dissipated after a few minutes" followed by a headache which "dissipated after a few minutes" as well. Then patient complained of nausea, no vomiting and "couldn't relax." Per wife, from around 1400/1500, patient stayed on his recliner while still having a conversation with her--"he didn't get up to eat." Last conversation they had was around 2000/2100. Per wife, at around 2100/2200, patient was quiet and when she checked on him, "he wasn't responding anymore." Wife then called 911, "but they couldn't revive him."

Soreness at injection site beginning 0230 hrs following an injection at 1400 hrs the day previously. Self-administered 1000 mg Acetaminophen PO. Just in second day now. Soreness less. Taking 500 mg Acetaminophen PO Q8hours

rash on the belly; This is a spontaneous report from a contactable consumer. An 80-year-old male patient (reporter's boss) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK9231) in the Hospital (a family member that works there and the worker's were allowed to pick one of their family members to give the vaccine to) via an unspecified route of administration on 10Jan2021 at 11:30 AM at a single dose on the left upper arm for COVID-19 immunization. The patient had no medical history. Concomitant medication included simvastatin (manufacturer unknown), dutasteride (manufacturer unknown) and montelukast (manufacturer unknown) all from an unknown date and unknown if ongoing. The reporter stated that her boss received the first dose on 10Jan2021 and developed a rash on the belly. She wanted to know if he could take the second dose as scheduled or if he needs to wait. He was scheduled in 3 weeks. He has a rash all over his belly and the doctor said it was like a reaction to the vaccine. She does not know if he has to go the ER or what. His primary care physician (PCP) ordered him Benadryl pills and ointment. The reporter confirmed that the patient was ordered both oral and ointment. The outcome of the event was not recovered.

Patient received first dose of the COVID-19 Moderna vaccine on 1/19/2021 at an outside facility (no lot #, route, or site available to me in electronic charting). Pt began having hypoxia, SOB, and a dusky appearance of extremities on 1/29/2021 and was brought by EMS to our hospital. PT is a DNR and family had been looking into a hospice sign up due to dementia and general decline in the weeks prior to hospitalization. Pt tested positive on admission for COVID-19 via PCR test on 1/29/2021. Pt continued to have respiratory decline, was put on comfort care per wishes of family/advanced directives, and he passed away the evening of 1/30.

After unknown time after injection, patient developed rash at injection site. Patient reported afterwards. Unknown intervention.

between 24 and 48 hours after receiving first vaccine patient broke out into blisters all over body. Particularly severe on shoulders, arms and inner thighs. Blisters were not itchy, but broke open and discharged. Patient put on oral steroids course and antibiotic doxycycline. Testing revealed that it was in fact an allergic reaction.

generalized itching 3 days after first vaccine given follow by drug rash in different parts of body starting one week after vaccine and persisting to today 2/4/2021

Arm was sore this morning and red; Arm was sore this morning and red; his left side of his face was swollen into his left side of his neck; his left side of his face was swollen into his left side of his neck; Headache; This is a spontaneous report from a contactable consumer. A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248) on right arm, via an unspecified route of administration on 21Jan2021 10:15 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) (home oxygen), heart disease, high blood pressure and diabetes. The patient's concomitant medications were not reported. The patient got the shot (vaccine) yesterday (21Jan2021) at 10:15 at the veteran administration. He got a headache right after that, just a slight headache. His arm was sore this morning (21Jan2021) and red and his left side of his face was swollen into his left side of his neck. The patient didn't receive any treatment for the problem and didn't visit any Physician Office/ Emergency Room. The outcome of events was unknown.

rash all over his back and it itched like crazy and then started bleeding; rash all over his back and it itched like crazy; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EK4176, via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunisation. Medical history included heart disorder from an unknown date. Concomitant medications included a lot of medications for his heart and stuff. In Jan2021 the patient experienced rash all over his back and it itched like crazy and then started bleeding when he scratched. He received Benadryl tablets lotion on it as treatment. The outcome of the events was unknown.

Approximately 18 minutes after administration of Pfizer COVID-19 vaccine IM 1st dose patient c/o having tongue swelling, hives to chin and facial redness. Administered Epi 0.3 mg IM to right deltoid approximately 20 minutes after vaccine administered. Right arm noted to have swelling at site of vaccine administration. IV access obtained and diphenhydramine 50 mg IV administered. NS IV started and approximately 100 ml given prior to EMS arrival. Pt did state he felt better after Epi 0.3 mg IM dose and diphenhydramine 50 mg IV dose provided. Pt alert and able to speak in complete sentences throughout event. Tongue swelling improved after epinephrine and diphenhydramine administered. Pt transported by EMS emergently to local emergency department for further observation and treatment.

Severe thrombocytopenia. Administration of dexamethasone and IVIG immune globulin. Petechiae over bilateral lower extremities and feet. Ecchymosis.

Patient is an 80 year old male who has a history of multiple medical problems, including body mass index of 30, hypertension, dyslipidemia, giant-cell arteritis on a slow prednisone taper (currently 2 mg daily), past pulmonary embolism on warfarin, sleep apnea, history of diverticulitis (treated in August 2020), past abdominal surgeries (including umbilical hernia repair ×2 and open recurrent incarcerated epigastric hernia repair with mesh in October 2020), chronic anemia, and type-2 diabetes. The patient had received the first dose of the COVID-19 (SARS-CoV-2) vaccine on January 31, 2021 and the second dose on February 21. He presented to his primary care provider?s office on February 22, 2021 with complaints of 10 days of progressive weakness and muscle soreness. The weakness had reportedly involved the bilateral thighs and arms and was associated with muscle aches. Blood pressure measured 90/40 mmHg and examination was notable for symmetrical proximal weakness in the upper and lower extremities. The peripheral blood leukocyte count measured 3.5 x10e3/µL, hemoglobin 8.3 grams per deciliter and platelets 147 x10e3/µL. A peripheral blood smear was consistent with neutropenia and normocytic anemia with 9% circulating blasts. Total CK measured 1424 U/L. The patient was referred to hematology/oncology and rheumatology and had appointment scheduled for both on February 26. With the above background, he presented to emergency room on February 24 with altered mental status and continued weakness. He was taken to the hospital by emergency medical services. A temperature of 103 degrees Fahrenheit was recorded when emergency medical personnel had arrived. The peripheral blood leukocyte count was 1.4 x10e3/µL for an ANC of 0.8 x10e3/µL. Hemoglobin was 8.1 g/dL and platelets 111 x10e3/µL. A few schistocytes and teardrop cells were noted. The serum creatinine was 1.47 mg/dL. AST was 174, ALT 91 and alkaline phosphatase 93 U/L. The lactic acid level of the venous blood was 2.1 mmol per liter. A repeat total CK was 4631 U/L. Sedimentation rate measured 34 mm/h and CRP 52.3 mg/L. Urinalysis showed 0-2 wbc?s/hpf, 0-2 rbc?s/hpf, 3+ blood, negative nitrites, negative leukocyte esterase. A haptoglobin level of the blood was within normal limits. The lactic acid level of the venous blood was 2.0 mmol/L. LDH measured 838 U/L. A ferritin level was 3464 nanograms/mL. A test for COVID-19 (SARS-CoV-2) was negative. A chest radiograph showed minimal streaky right basilar atelectasis, trace left effusion and a mildly enlarged cardiac silhouette. A head CT showed no acute abnormality. An abdominopelvic CT without contrast was limited by motion artifact. No acute intra-abdominal or pelvic finding was noted. Nonspecific soft tissue stranding was seen in the right inguinal region. There was no soft tissue gas or drainable fluid collection. Cultures of specimens of the blood were obtained. The patient was started on empiric cefepime, vancomycin and doxycycline and admitted for further care. A peripheral blood smear for intracellular parasites was negative. The admission blood cultures came back positive for E. coli. With the blood culture results, the vancomycin and doxycycline were discontinued. The E. coli isolate has since been determined to be pansusceptible. A MRSA PCR of the nares was negative. He was found on exam to have swelling, cellulitis and exquisite pain of the right groin area on February 25. Surgical consultation was pursued. They did not feel that he had necrotizing fasciitis. The CT scan of the abdomen and pelvis was repeated with contrast, revealing increased extensive subcutaneous edema of the right groin region with extension into the thigh musculature and mild extension into the right inferior pelvis. There was no associated soft tissue gas or drainable abscess. A bone marrow biopsy was performed February 25. Results showed acute undifferentiated leukemia with 60-70% infiltration of the bone marrow with blasts. The blasts were negative for lineage markers. He was faintly CD33 positive. He is felt to likely have acute myeloid leukemia. Cytogenetics are pending.

Pulled his band aid there was a little blood; This is a spontaneous report from a contactable consumer (wife of patient). An 80-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 27Jan2021 at single dose (left arm) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Her husband had his first dose today but at a different location and when he pulled his band aid there was a little blood. This was his first dose and it was given in his left upper arm. Outcome of event was unknown. Information about Lot/ Batch has been requested.

Moderate allergic reaction; itchy skin; itchy eyes; Headache; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 9263), via an unspecified route of administration in right arm on 24Jan2021 11:45 at a single dose for COVID-19 immunization. Medical history included Diabetes2, HiBloodPress and HiCholesterol. Concomitant medication included lisinopril, simvastatin, and unspecified diabetes medication. On 26Jan2021, the patient experienced moderate allergic reaction, itchy skin, itchy eyes and headache. The patient was taking antihistamines with some relief for moderate allergic reaction, itchy skin, itchy eyes. There was no treatment for headache. The outcome of the events was recovering. Prior and since the vaccination, the patient was not tested for COVID-19. The events were assessed as non-serious.

bad body rash; shingles; This is a spontaneous report from a contactable consumer (wife). An 80-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) via an unspecified route of administration in the right arm on an unspecified date (about three weeks ago) at a single dose for COVID-19 immunisation. There were no medical history and no concomitant medications. The reporter noted that both she and her husband took the Covid vaccine about 3 weeks ago, stated is time to take the second part. She read the pamphlet that came with it when we got the vaccine, said that a person could have a bad body rash. She stated her husband has had a bad body rash on an unspecified date. Noticed the rash right away, maybe the day or two after and it has persisted since, it was a nightmare for him, that she thought it was shingles on unspecified date. They went to the dermatologist and he told them it could be attributed to him eating red meat. The reporter wanted to know what they should do for it. Investigation assessment was noted as no. The outcome of rash was not recovered and of shingles was unknown.

Rash/hives all over his body and large swollen lump on the back. Itchy and irritable. Doctor prescribed Benadryl and Prednisone 10 mg.

10/5 :Fri 2:00 PM Nausea,9:30 PM Fell down and could not get up without assistance, unable to walk or setup, Dizzy and confused, bad itchy rash on body including large red spots(stomach, back, legs, arms, head , neck) Sat 10/6 admitted at Hospital tests results dehydration. Continued problem with walking. Tues 10/9 visit with primary doctor. Pictures were taken of his body and entered in computer at Clinic. Walking issues getting better.

until the vein opened up and was squirting out blood; until the vein opened up and was squirting out blood; a severe itching rash; This is a spontaneous report from a contactable consumer. An 80-year-old male patient (reporter husband) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on 29Jan2021 12:00 at SINGLE DOSE in left arm for COVID-19 immunisation. Medical history included ongoing asthma Onset Date: Probably about 20 years ago, ongoing chronic obstructive pulmonary disease Onset Date: Probably about 20 years ago, ongoing overweight Illness/AE: Little overweight. There was none family medical history relevant to AEs. There were no concomitant medications. The patient received first dose of bnt162b2 (Lot number: EC3246) on 08Jan2021 in Left arm for COVID-19 immunization. The patient experienced a severe itching rash on 01Feb2021 with the outcome not recovered. Area where a vein is very close under the skin itching that he scratched until the vein opened up and was squirting out blood on 24Feb2021 with unknown outcome. The rash hasn't gotten worse, and it is staying the same. The AEs require a visit to: Emergency Room and Physician Office. The patient underwent lab tests and procedures which included biopsy: unknown results on 25Feb2021, Bloodwork: Nothing showed up on this test. This is a non-serious report. The outcome of event a severe itching rash was not recovered, outcome of the other events was unknown. This consumer reported she and her husband were administered second dose of Pfizer COVID-19 Vaccine on 29Jan2021. Her husband apparently has had a reaction of very itchy rash to the Pfizer COVID-19 Vaccine. She reported that the patient saw the Dermatologist and the Dermatologist thinks the Reaction of very itchy rash is a reaction to the Pfizer COVID-19 Vaccine. Regarding testing/investigations related to this report caller provided that the primary care physician ordered bloodwork and nothing showed up in that. Biopsy was taken 25Feb2021 to see if reaction of very itchy rash is related to the Pfizer COVID-19 Vaccine When queried if any adverse event required Emergency room visit, physician's office visit or hospitalization caller reported that the patient was seen in the emergency room, but not admitted to the hospital on 24Feb2021 related to patient's event of area where a vein is very close under the skin itching that he scratched until the vein opened up and was squirting out blood event-they got that situated in the emergency room. Emergency room staff were the ones that recommended that the patient start Claritin. Dermatologist office visit was regarding the reaction of very itchy rash. The patient is taking Claritin and using Calamine lotion or Calamine spray for these events. Reaction assessed: Reaction of very itchy rash, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.

Muscle ache; Spasms/buttock spasms/ muscle cramps; Injection site hurt; walking difficulty; walking painful; both legs are hurting; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3242), via an unspecified route of administration in the left arm on 06Feb2021 (at the age of 80 years-old) as a single dose for COVID-19 immunization. Ongoing relevant medical history included myopathy, neuropathy, neurological issues, and chronic pain. Additional medical history included the patient also had spinal cord surgery several years ago and sensation issues for a lot of years. The patient's concomitant medications were not reported. On an unknown date the patient experienced muscle ache, muscle spasms, injection site hurt bit, walking difficulty and walking painful. On 10Feb2021 the patient experienced both legs are hurting. The patient reported that they had the first vaccine on the 06Feb2021 and the injection site hurt a little bit and a couple of days went by and then the patient had the muscle aches and all of a sudden it was severe with muscle cramps and spasms from the buttocks down the leg on the left side. The patient stated that now both legs are hurting a lot from about 10Feb2021. The patient stated that he could barely walk and it was very painful to walk. The patient stated he was using a walker, cane, and holding onto objects when walking. The patient said it is a little better, but the patient still has to take baby steps and the patient is currently having a buttock spasms. The patient stated they have the second appointment 27Feb2021 and the patient is leery of taking the second dose as the patient has not been able to function for the last 2.5 weeks and is not sure about getting the second dose. The clinical outcome of the muscle ache, injection site hurt, walking difficulty, walking painful and both legs are hurting was unknown. The outcome of the event muscle spasms/buttock spasms/ muscle cramps was not recovered.

Site: Swelling at Injection Site-Mild, Additional Details: Patient received the vaccination and then immediately developed a hard knot at the site of the injection, it was slightly bigger then a marble. The patient had no other symptoms and felt mild discomfort at the site. He stayed at the store for roughly 45 minutes after the shot with no change.

Shaking Uncontrollably, Sweats, Dry mouth, sore all over, injection site was swollen, memory loss, confusion

mild difficulty breathing; swelling lymph nodes; feels like he got the flu; nausea; pain at injection site; headache; tired; Low Appetite; This is a spontaneous report received from sponsored program , from a contactable consumer (patient's son). An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an unknown date in Feb2021, as single dose for COVID-19 immunisation. After receiving the first dose of the BNT162B2, approximately in Feb2021, the patient experienced pain at injection site, headache, swelling lymph nodes, nausea, tired, mild difficulty breathing and low appetite. He also felt like he got the flu. The patient's medical history and concomitant medications were not reported. It was informed to reporter to consult HCP since his father was experiencing mild difficulty breathing which require immediate medical attention. All the other side effects except low appetite have been reported with the BNT162B2. The vaccine might vary person to person the side effects listed are not different from one dose to another. These side effects could occur with either dose. The duration of the symptoms is undetermined and asked him to consult his HCP if symptoms worsen or don't go away. No treatment was received for the events. The outcome of the events was unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.

Red, itchy rash on legs and arms. It started four and a half days after the 2nd COVID vaccination. It lasted approximately 2 days. I treated it with hydrocortisone cream which reduced the itchiness somewhat.

Received 1st Pfizer dose 3/2/2021, on 3/4 pm he started not feeling well. On 3/5 he slept through the day and was not feeling well. He reported his legs and back were hurting, and he had difficulty walking due to problems with his balance. He got up at 9pm and fell in the bathroom. He was dizzy. His wife assisted him back to bed. He was not able to sit, he would fall over. On 3/6 his balance was still off. His wife assisted him to the car and took him to the Hospital. They treated him for dehydration and discharged him. On 3/7 he developed a rash over his body, "big red spots". 3/8 his wife called the physician , who saw him the following day, on 3/9. He was advised not to take the 2nd Pfizer vaccine. The rash lasted 5-6 days. At the time of this report, his symptoms have resolved. His wife reports she completed a VAERS. His report number is 346254

rash all over his body; This is a spontaneous report from a contactable nurse (patient's spouse). An 80-year-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular at the age of 80-years-old, administered in Arm Left on 17Feb2021 13:30 (Lot Number: EN6201) as a single dose for COVID-19 immunization. Medical history included recently, the patient had retinal detachment and had surgery for that on 18Jan2021, then he had to go back 26Feb2021 to have surgery on the same eye, he has a pacemaker. Concomitant medication included unspecified eye drop. The patient previously received bnt162b2 (BNT162B2), dose 1 intramuscular at the of 80-years-old, administered in Arm Left on 29Jan2021 11:00 (Lot Number: EL9263) as a single dose for COVID-19 immunization. The patient experienced rash all over his body on 19Feb2021. Reporter's husband (patient) has a rash all over his body. The rash has not bothered him. Reporter noticed the rash 3 days after he received the second dose, clarified as she noticed the rash 2 days after he received the second dose. Reporter just happened to walk into the room while patient's shirt was off. She was like "Oh my goodness, what is that." She has looked a couple of more times at patient's rash. After patient first gets out of the shower, his rash is more pronounced. She is not sure if it is because of the warm water or washing up that makes it more pronounced. She can run her hand over the rash and still feel it. The rash had gotten slightly better. Reporter stated that the rash has not concerned her until it has not gone away. Reporter is trying to decide whether or not to take patient to the doctors office since the rash has not went away. The outcome of the event rash was unknown. The event was considered as serious (medically significant).; Sender's Comments: Based on available information, a possible contributory role of subject product, BNT162B2 vaccine cannot be excluded for the reported event of rash, based on temporal relationship and the known product safety profile. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Patient started having rash on his feet the same day and it was getting all over his body and also started swelling. he was even hospitalized. dr recommended not to get the second dose of covid vaccine

Developed a rash over neck, back arms and spreading.; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 12:00 (Batch/Lot number: FL9265) at single dose for covid-19 immunisation. Medical history included none. The concomitant medications were not reported. The patient reported, developed a rash over neck, back arms and spreading on 08Feb2021 on doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken with Triamcinolone 0.1% Cream for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient not been tested for COVID-19. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.

Pt developed rash/hives to neck/chest/back/ head & scalp/ Left arm & Left hand. L arm/hand swelled up & open, draining wounds developed. OPen areas to neck/back developed. UNresolved with Rx & OTC TX

Painful and shingle-like reaction. Throbbing pain down the neck and left shoulder. Symptoms persist almost 14 days after vaccine completion.

Soreness at site of injection, slight headache and nausea, general body aches and pains. Lasted for two days then subsided. Temperature 100.7 degrees F at 7 AM on 04/16/2021 declined to 97.6 degrees F. by 4 PM 04/17/2021 (normal for me)

Could not sleep for two days; Sweaty; Chills; Face and palms got really red; Indigestion; Constipation; deathly sick over the weekend; This is a Spontaneous report from a contactable consumer (patient). An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EM6207), second dose via an unspecified route of administration, administered in Arm Left on 20Mar2021 15:00 (Batch/), single dose for covid-19 immunization. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing Diagnosed with COPD 3-4 years ago and is not taking any medication for it, (blood pressure) hypertension from an unknown date and unknown if ongoing had been taking Atenolol for blood pressure. Concomitant medication included atenolol. The patient had the first dose of bnt162b2 vaccine (Lot EN6023) on 27Feb2021 for covid-19 immunization and experienced hypertension aggravated. He went back to doctor and had been taking Atenolol for blood pressure. It has always been dose 50/25. His blood pressure was up just a bit and he cannot verify who this girl was that changed it to 100/25. He did not like the way he felt and eliminated it and went back to the previous dose. He had two over a period of 2-3 days. It is in a pharmacy vial. He does not have a lot or expiration for the Atenolol 100/25. The date his blood pressure was up was for the past couple of times.Usually, it is 120/60-70 and then it jumped up to 150/60-70 and that is why it needed to be changed. It was filled on 18Mar2021, which was after first vaccine but before second dose. Patient got deathly sick over the weekend on 02Apr2021. He had the shot on 20 Mar 2021, and it has been more than the two days you could have a reaction. He was deathly sick. On 02Apr2021, he had just about all of the symptoms; sweaty, chills, face red, and hands red, indigestion, constipation and could not go to the bathroom. He was about as sick as he had ever been. He know it is not supposed to be that long. He could not sleep for two days. His face and palms got really red. He did not have a fever. He walked the floor and only slept 2 hours in two days. On 31Mar2021, he goes to a pain center and got shots in his neck. He asked the doctor if his shot had anything different than he had been getting and he confirmed that it was no different. He never had a reaction before the one he got on 31Mar2021, and thought it may have been the virus shot. He said one other thing happened and is not sure if it had anything to do with it or not. He just started to feel worse and worse. Today is the first day he felt better. He is 80 and has not been this sick. It got really bad but today it is much better. He did not sleep for two days and last night he slept and feels better. For the indigestion, it got worse before it got better. For constipation, he got relief last night and that is why he feels better today. NO ER or physician's office required- He had a previously scheduled office visit for pain center. The outcome of the events was recovering. The event insomnia was assessed by the reporter as medically significant. Information on Lot/Batch number was available. Additional information has been requested.

left cheek was swollen and red; left cheek was swollen and red/red dots on the skin near his left eye; This is a spontaneous report received from a contactable consumer (patient) reported for himself. A 80-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date was not provided), via an unspecified route of administration, in last week Tuesday, on 06Apr2021, as a single dose for COVID-19 immunisation. Patient medical history included hernia and relapsing polychondritis. Concomitant medications were not reported. Upon call E-transferring to unit the patient mentioned that his symptoms started last week and he was able to notice a couple a days ago that his left cheek was swollen and red and he thought that it was sunburn but it started to itch a couple of days ago and his cheek was swollen to about the size of a softball in circumference and about 1/8th to 1/16th of an inch thick which takes up the whole check. He further stated that he also had red dots on the skin near his left eye. He mentioned that he will be seeing his Cardiologist shortly for a hernia that appeared. The patient has an extremely rare condition called Relapsing Polychondritis in which his ears bleed from and takes steroids for it. He is asking for what to do with his swollen cheek and should he proceed with his Hernia operation. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Received first dose COVID 19 vaccine and started to notice subtle hair loss on head and turning gray quickly. Received second dose COVID 19 vaccine and within 24 hours noticeable head hair loss (hair now completely gray/white) and in immediate days following noticed hair loss to arms, facial hair not growing in (i.e. beard) as well.

blisters on lift hand: sunday rash on both hands and apparent 100 small blisters on the back of each hand; monday doth hands and forearms torned solid red; either monday evening or tuesday evening my whole body itched and continued to do so for the next day and half. Except for the itching i felt fine

This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reported). A 80-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8735, Expiration date 31 Jul 2021), via an unspecified route of administration in right arm on 22Apr2021 at 10:30 as single dose for COVID-19 immunization. Medical history included malignant melanoma from an unknown date in Dec 2019 (ongoing), illness from an unknown date. Concomitant medications included nivolumab (240 mg/m2) taken for malignant melanoma, start and stop date were not reported. The patient previously took penicillin b and experienced hypersensitivity. On 22Apr2021 patient got the 1st dose and on 25Apr2021, The patient experienced he broke out in a rash/he says the red dots are still there on his body with outcome of not recovered, itching with outcome of not recovered , his is a little blurry with outcome of unknown , rashes all over his stomach with outcome of unknown. The patient underwent lab tests and procedures which included positron emission tomograms on 19 Jan 2021. Therapeutic measures were taken as a result of he broke out in a rash/he says the red dots are still there on his body (rash), itching (pruritus). The CDCs Advisory Committee on Immunization Practices (ACIP) has provided interim considerations for the use of COVID-19 mRNA vaccines (like the Pfizer-BioNTech COVID-19 Vaccine) during the Emergency Use Authorization. These interim considerations state that antihistamines (like diphenhydramine) should not be taken prior to vaccination to prevent allergic reactions, including anaphylaxis (anaphylaxis is a serious and potentially life-threatening allergic reaction). Follow-up on (26Apr2021): The patient took COVID 19 vaccine to protect his wife and himself for immunity against COVID 19. He said that is a fusion solution and he started taking this a month after the doctor cut the melanoma out of his head and it was cancerous, clarified as melanoma and he is on the last treatment. On the last PET scan, there was no melanoma on any place on his body. He says the PET scan was probably at least 2 months ago. He says he had a "C scan" last week but he hasn't gotten the results of that. He stated that took a couple Benadryl and it doesn't seem to be quite as bad as it was. He says the red dots are still there on his body. He confirms the rash has improved a little bit. He initially provides the Lot number ER3735. He has trouble reading his vaccination card, stating his is a little blurry. He gets his wife's card to compare as him and his wife received the vaccine at the same time. He explains his wife's card says ER8735, he believes the Lot number is probably the same on his card but the top part of the number 8 isn't connected and it made it look like an 8. He gets his magnifying glass out and confirms the Lot number is ER8735. He says that this is his first dose of the COVID-19, The patient did not receive any other vaccine in four weeks. The outcome of the events rash and itching was recovered and the outcome event little blurry was unknown. No Follow-up attempts are needed. No further information expected.

Rash on inner from armpit to wrist itchy, red, blotchy; Rash on inner from armpit to wrist itchy, red, blotchy; Rash on inner from armpit to wrist itchy, red, blotchy; This is a spontaneous report from a contactable consumer (patient). A 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: Elo142), via an unspecified route of administration on 21Jan2021 at 12:00 PM as a single dose for covid-19 immunisation at Doctor's office/urgent care. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks. On 21Jan2021, the patient experienced rash on inner from armpit to wrist itchy, red, blotchy. No treatments were received for events. The patient was not recovered from the events. Follow-up attempts are completed. No further information is expected.

Skin rash on his whole body; Urticaria; Right mouth swelling/left mouth swelling; Swelling face; Lower lip is swollen; Touches his face, the skin feels thicker; This is a spontaneous report from a contactable physician (patient). An 80-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Apr2021 as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that about 13 days ago, on 22Apr2021, he had the Pfizer Covid-19 Vaccine. He thinks that about one week or 8 days later he had a skin rash on his whole body. Treatment of skin rash on his whole body was applied. The patient added that he took Benadryl 25 mg only once and and a few hours later the rash faded. One day later, it was completely gone and was no more (as reported). Today, this morning (as reported), the patient woke up and his right mouth right below the chin to the mouth area to the lower lip is swollen. The patient adds that his body had urticaria. He took Benadryl, another one, 25 mg and one or two hours later his body urticaria disappeared. Right mouth swelling: the patient adds that his face was swollen below the cheek to lower the lip line and it is not disappearing but seems a little bit smaller. It used to be a bump and now it feels like skin is still thick but he feels better on the right side. Left mouth swelling: the patient adds that he thought probably he would caller interrupts statement and says he does not know why but it turned to the left side, the left lower lip and it became swollen again (as reported). The right side has come down a little more but still feels like the inside of his mouth on the right side, he does not feel anything now, except when he touches his face, the skin feels thicker (as reported). Now, it has become to the left side left lower lip area, and lower chin. He does not know what to do. The patient confirms that this was his first dose of the Pfizer Covid-19 Vaccine. The outcome of the event "Skin rash on his whole body" and "Urticaria" was resolved, the outcome of the other events was unknown. No follow up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Assuming a plausible drug-events temporal association and considering the nature of the reported events suggestive of a possible allergic reactions (the events urticaria and skin rash are also mentioned in the safety profile reported of the suspect product), the company deems there is a reasonable possibility that all the reported events are related to BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administration. The impacts 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.

blistering rash to back and abdomen; blistering rash to back and abdomen; This is a spontaneous report from a contactable consumer or other non hcp. A 80-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL3246), dose 1 via an unspecified route of administration, administered in Arm Right on 20Jan2021 14:00 as SINGLE DOSE for an unspecified indication. Medical history included hypertension, asthma and drug hypersensitivity from an unknown date. Concomitant medication(s) included benazepril, hctz (HCTZ), atorvastatin, montelukast for an unspecified indication. The patient experienced blistering rash to back and abdomen on 22Jan2021. Therapeutic measures were taken as a result of blistering rash to back and abdomen. Outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Had inflammation on face red as a beet; Malaise; had arm hurt, Left arm; Headache; Weakness; Dizziness; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Apr2021 07:30am, at the hospital, (at the age of 80-years-old) as single dose for Covid-19 immunisation. Medical history included eczema from an unknown date and unknown if ongoing, drug hypersensitivity to penicillin (about 21 years old, Inflammation and redness, system gets flush), sulfonamide derivatives. The patient previously took aspirin (e.c.), keflex, sulfur, cellcept and experienced hypersensitivity to all. Concomitant medication included dupilumab (DUPIXENT) taken for eczema, start and stop date were not reported. The patient had inflammation on face, red as a beet, (dermatitis) (non-serious) on an unspecified date with outcome of unknown , malaise (non-serious) on an unspecified date with outcome of unknown, had arm hurt, left arm (pain in extremity) (non-serious) on an unspecified date with outcome of unknown , headache (non-serious) on an unspecified date with outcome of unknown , weakness (non-serious) on an unspecified date with outcome of unknown , dizziness (non-serious) on an unspecified date with outcome of unknown. The clinical course was as follows, at about 4pm the patient went outside, he "felt flushed, but didn't look in the mirror a friend told me to put sunblock on. I looked at my face and saw my face beet red. I just laid down, my arm felt bad, like a Charlie horse, like someone smacked me in the arm." Caller states his symptoms are, "basically inflammation through the body, then headache, weakness, dizziness, malaise, one good thing, no fever or nausea. Some uneasiness, vacillation, physical weakness. The patient don't drink alcohol, drink water and took Tylenol after the vaccine. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

rash/itchy spots located on his upper chest, shoulder and back; rash/itchy spots located on his upper chest, shoulder and back; This is a spontaneous report from a contactable consumer (Patient himself). This is report 1 of 2. A 80-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: PHFEEL9263, Expiration date: Unknown) via intramuscular route of administration in left arm on 28Jan2021 12:00 as single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. No prior vaccinations within 4 weeks. No additional vaccines administered on same date of the Pfizer suspect. On 29Jan2021, the patient experienced rash/itchy spots located on his upper chest, shoulder and back. Caller reported that his only reaction he thinks he had from the shot was itchy spots located on his upper chest, shoulder and back. He states it looks like his rash/spots are subsiding. It`s a lot lighter in color and hasn't spread. It states it has somewhat improved. Caller mentions he was a little hard of hearing. The caller had his Vaccine Record Card but could not determine if the Lot number had an H or K in it. He states it`s kind of scribbled. He gets his wife to look at the card as well. He states the Lot number looks to be "PHFEEL9263" on the card. The person didn't write it very clearly. When probed for concomitant products and medical conditions, the caller states " I was not going to go through my whole medication list. I was pretty healthy. No further details were provided or obtained. The outcome of the events was recovering. Follow-up attempts are completed. No further information was expected.

Redness, rash and slight swelling at the injection site. Still there a week after the injection.; Redness, rash and slight swelling at the injection site. Still there a week after the injection.; Redness, rash and slight swelling at the injection site. Still there a week after the injection.; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male consumer received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6202, Expiry Date: Unknown), via an unspecified route of administration on left arm on 27Feb2021 at 02:15 PM, at single dose for COVID-19 immunization at Hospital. The patient medical history included Cancer, pneumonia, flu, COPD on an unspecified date and had no Known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 . The Patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EM9809), via an unspecified route of administration on left arm on 06Feb2021 at 04:45 PM, at single dose for COVID-19 immunization. Patient received other unspecified medications in two weeks, all from an unspecified date and unknown if ongoing. patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. On 01Mar2021, Patient experienced, Redness, rash and slight swelling at the injection site. Still there a week after the injection. patient did not receive any treatment for events. Outcome of all the events was not recovered. No follow-up attempts are possible. No further information is expected.

Primary Physician recommended I see a Dermatologist, which I did on 06/16/2021 and she concluded the malady was a result of "bruising". I believe I have "Covid Arm" which I experienced the first day after the first shot. Initialy it was just my right arm, but following the second shot I developed it in both arms. I have a rash on my upper and lower right arm and a rash on my lower left arm. My hands and ankles often itch. I also have recurring red areas which were present on the second day after the first and second shot and only in my biceps area. I experience days of tiredness, and sometimes fatigue. I currently have all these symptoms. DOB is 05/30/1940.

ED to Hosp-Admission Discharged 6/18/2021 - 6/19/2021 (17 hours) Hospital MD Last attending ? Treatment team Musculoskeletal chest pain Principal problem Hospitalist Medicine History and Physical Date: 6/18/2021 Admission Date: 6/18/2021 PCP: MD DOB: 3/16/1940 Hospitalist: MD Assessment/Plan Medical Problems Hospital Problems POA * (Principal) Atrial fibrillation with RVR (CMS/HCC) Yes COVID toes Yes Angina of effort (CMS/HCC) Yes Atrial fibrillation (CMS/HCC) Yes Medical Problems Plan: 1. Will be admitted to icu because of angina like smptoms montor 2.repat tropon 3. Check bmp bnp and echo in am 3.check tsh mag 4.covid precautions5. Cardiology and ID consut in am if needed VTE prophylaxis: already on eliquis avoid nsaids because he is on eliquis will try tylenol if needed morphine for severe pain Full Code History of Present Illness Pt. is an 81yr male. Very pleasant male with history of choronic afi on eliquis history of hypertenson hyperchol Had ultrasound of the carotid arteris which showed stenosis Today he was mowing lawn developed left sided cheestpain pressure with no radiation to the neck arm s shoulder he was not diaphoretic. No fever chills or cough his covid is postive denies nausea vomiting or abdominal pain Came to the ER initially he was tachycardic with heart rate of 136 ekg showed right bundle with A-fib His initial troponin is negative less than 0.03 Has wbc cont of 11.8 hb 14.3 hct Normal platelets 188 na 142 k4.0 cl 110 c02 223 bun 17 cr 1.07 ast 15 alt 16 blood sugar of 148 Continue with chestpressure little anxious sats stable Considered his multiple risk factors and rapid a fib on arrival therefore he will be admitted in icu And montor his oxygen sats in case if it get rapid may need iv blocker or amiodarone Family history father died at the age of 63 from cAD /MI Mother died of old age at 93 Assessment Review of Systems Constitutional: Negative for activity change, appetite change, chills, diaphoresis, fatigue, fever and unexpected weight change. HENT: Positive for trouble swallowing. Negative for congestion, ear discharge, mouth sores, sinus pressure, sinus pain, sore throat and voice change. Eyes: Positive for visual disturbance. Negative for photophobia, pain and redness. Respiratory: Positive for chest tightness and shortness of breath. Negative for apnea, cough, choking and wheezing. Cardiovascular: Positive for chest pain and palpitations. Negative for leg swelling. Gastrointestinal: Negative for blood in stool, diarrhea, nausea and vomiting. Endocrine: Negative for cold intolerance, heat intolerance, polydipsia and polyphagia. Genitourinary: Negative for difficulty urinating, flank pain and hematuria. Musculoskeletal: Positive for arthralgias. Negative for back pain, gait problem, joint swelling, myalgias, neck pain and neck stiffness. Skin: Negative for color change, pallor and rash. Neurological: Positive for headaches. Negative for dizziness, tremors, seizures, syncope, facial asymmetry, speech difficulty, weakness and numbness. Psychiatric/Behavioral: Negative for agitation and behavioral problems. Past Medical, Social and Family History Medical History No past medical history on file. Surgical History No past surgical history on file. Social History Socioeconomic History ? Marital status: Married Spouse name: Not on file ? Number of children: Not on file ? Years of education: Not on file ? Highest education level: Not on file Occupational History ? Not on file Tobacco Use ? Smoking status: Not on file Substance and Sexual Activity ? Alcohol use: Not on file ? Drug use: Not on file ? Sexual activity: Not on file Other Topics Concern ? Not on file Social History Narrative ? Not on file Social Determinants of Health Financial Resource Strain: ? Difficulty of Paying Living Expenses: Food Insecurity: ? Worried About Running Out of Food in the Last Year: ? Ran Out of Food in the Last Year: Transportation Needs: ? Lack of Transportation (Medical): ? Lack of Transportation (Non-Medical): Physical Activity: ? Days of Exercise per Week: ? Minutes of Exercise per Session: Stress: ? Feeling of Stress : Social Connections: ? Frequency of Communication with Friends and Family: ? Frequency of Social Gatherings with Friends and Family: ? Attends Religious Services: ? Active Member of Clubs or Organizations: ? Attends Club or Organization Meetings: ? Marital Status: Intimate Partner Violence: ? Fear of Current or Ex-Partner: ? Emotionally Abused: ? Physically Abused: ? Sexually Abused: No family history on file. Allergies and Medications No Known Allergies Prior to Admission medications Medication Sig Start Date End Date Taking? Authorizing Provider apixaban (ELIQUIS) 5 mg tablet Take 5 mg by mouth 2 (two) times a day Yes Provider, Historical, MD atorvastatin (LIPITOR) 10 mg tablet Take 10 mg by mouth at bedtime 5/20/21 Yes Provider, Historical, MD clonazePAM (KlonoPIN) 0.5 mg tablet Take 0.5 mg by mouth at bedtime 6/14/21 Yes Provider, Historical, MD metoprolol succinate XL (TOPROL-XL) 25 mg 24 hr tablet Take 12.5 mg by mouth daily 6/2/21 Yes Provider, Historical, MD NIFEdipine XL (PROCARDIA XL) 30 mg 24 hr tablet Take 30 mg by mouth daily 6/12/21 Yes Provider, Historical, MD omeprazole (PriLOSEC) 40 mg capsule Take 40 mg by mouth daily 5/26/21 Yes Provider, Historical, MD tamsulosin (FLOMAX) 0.4 mg capsule Take 0.4 mg by mouth daily 4/26/21 Yes Provider, Historical, MD Objective Objective Current Min/Max Temperature: 36.1 °C (97 °F) Temp Min: 36.1 °C (97 °F) Max: 36.1 °C (97 °F) Heart Rate: 99 Pulse Min: 80 Max: 116 Resp: 18 Resp Min: 18 Max: 18 BP: (!) 148/89 BP Min: 121/103 Max: 148/89 SpO2: 96 % SpO2 Min: 94 % Max: 98 % No intake/output data recorded. Weight: Wt Readings from Last 1 Encounters: 06/18/21 75.8 kg (167 lb 1.7 oz) Physical Exam Physical Exam Vitals reviewed. Constitutional: Appearance: He is well-developed. He is not ill-appearing or diaphoretic. HENT: Head: Normocephalic and atraumatic. Eyes: Extraocular Movements: Extraocular movements intact. Pupils: Pupils are equal, round, and reactive to light. Neck: Vascular: No hepatojugular reflux or JVD. Trachea: No tracheal deviation. Cardiovascular: Rate and Rhythm: Rhythm irregular. Pulmonary: Effort: Pulmonary effort is normal. No accessory muscle usage. Breath sounds: Normal breath sounds. No stridor. Abdominal: General: Bowel sounds are normal. There is no abdominal bruit. Palpations: Abdomen is soft. There is no splenomegaly. Tenderness: There is no abdominal tenderness. There is no rebound. Musculoskeletal: Cervical back: Normal range of motion and neck supple. Lymphadenopathy: Cervical: No cervical adenopathy. Skin: General: Skin is warm. Capillary Refill: Capillary refill takes less than 2 seconds. Coloration: Skin is not cyanotic or pale. Findings: No rash. Nails: There is no clubbing. Neurological: General: No focal deficit present. Mental Status: He is alert. Cranial Nerves: No cranial nerve deficit. Motor: Weakness present. Psychiatric: Mood and Affect: Mood is anxious. Signed, MD Hospitalist Medicine 6/18/2021 10:08 PM

shortness of breath; The shortness of breath has continued and has gotten a little worse; Nasal congestion; Coughing; heaviness in chest; It was like lumps; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 13Feb2021 12:10 (at the age of 80 years old) (Batch/Lot Number: EL9269; Expiration Date: 31May2021) as single dose for COVID-19 immunisation. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jan2021 (at the age of 80 years old) (Batch/Lot Number: EL3248; Expiration Date: 30Apr2021) as single dose for COVID-19 immunisation. Medical history included Heart bypass, it was 18 years ago. It was a aortic valve replacement, ongoing lymphoma cancer, and it is gone at this point, had shingles on the right side in 2015, skin cancer in both ears in 2016. Concomitant medications included ongoing warfarin sodium (COUMADIN), ongoing warfarin deanol, ongoing carvedilol, ongoing atorvastatin calcium (LIPITOR ORIFARM), ongoing atorvastatin, ongoing hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ), ongoing gabapentin (GABAPENTIN) taken for restless legs syndrome, ongoing acetylsalicylic acid (BABY ASPIRIN), ongoing turmeric and bromelain, ongoing ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION) taken for macular hole, ongoing loperamide hydrochloride (IMODIUM) taken for diarrhoea, ongoing bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10), ongoing potassium, ongoing Calcium citrate magnesium zinc all in one pill 80mg Magnesium, 500mg Calcium, 10mg Zinc, 20mg B6 taken for restless legs syndrome. Has been on his normal medications for years and nothing has changed. Has been on all of these medications at least 15 years, or more than that, maybe 18 years. The patient experienced shortness of breath since Feb2021 (at the age of 80 years and 6 monthes). He received both doses of the Pfizer Covid-19 Vaccine and received his second dose 13Feb2021. He has been to his doctor and has been treated with antibiotics and Prednisone. He wanted to know what he should do about it. Caller's shortness of breath began a couple of weeks after his second dose in Mar2021, where it became noticeable, and it continues. The patient would like to know if others have reported shortness of breath after receiving the Pfizer Covid-19 Vaccine. He has been experiencing shortness of breath since Feb2021. Maybe it is a side effect of the Covid vaccine, he does not know. First stated that it was around 15Feb2021 or earlier, when he first went to the doctor. He stated that he did start experiencing it before then. He wouldn't of went to the doctor if he didn't have that. Wife was brought on the phone to describe the event further. Stated that 01Mar2021 is when he first went to the doctor. They went on vacation on an unspecified date in Mar2021 and his wife had to take him to a clinic there that it was around 09Mar2021. He has had 4 series of antibiotics and prednisone since that first visit in Mar2021. When he got home, he went to the doctor again and they gave him more antibiotics and Prednisone. Then again in May, he had another round of it, and is still experiencing shortness of breath. He had also had other symptoms at that time. He had a lot of congestion. It did not stop but that has kind of subsided. The shortness of breath has remained. He had heard a news report stating shortness of breath symptoms have been reported regarding the COVID vaccine. He had his last shot 13Feb2021, he thinks it was. Soon after, he started having the shortness of breath. At first, he didn't relate it to the Covid shot. He does have heart problems. The first antibiotic was Azithromycin, it was with the Prednisone, It was the ZPack. He took it for 6 days and then tapered one every day. In Mar 2021 he took Medrol pack, which was 4mg tablets. They were different Prednisones and different antibiotics each time. The last one he took was Doxycycline, which was 40mg and he took it for 4 days. Can't remember what the other one was. Caller states that he had the Zpack from the clinic and his doctor gave him Doxycycline after he came home. It was a different amount of Prednisone each time. He had a lot of allergy like symptoms with nasal congestion and coughing. States that it was clear congestion and was probably 3 times as thick as with normal nasal problems. It was like lumps, was clear and was coughing it up. The congestion started when he was coughing up stuff. The last time his doctor gave him nasal spray, Azelastine HCI, which was in a spray bottle with 30ml. He stopped it after a period of time. He still has some congestion every day, but it is not near what it was before. The Prednisone and antibiotic lessened the problem along with the nasal spray and really helped. The shortness of breath has continued and has gotten a little worse. He used to be able to walk 3 quarters of a mile every day but now he probably can't walk 4 blocks. Sometimes, just sitting on the couch, watching TV, he gets heaviness in his chest. He has to breathe really deep to get it fixed. When he had his oxygen level tested, at the doctor's office, it is always 98, 99 or 100 percent. The doctor listens to his lungs and he doesn't see or hear anything that is going on. He had an X-ray for his lungs they didn't see anything there either. Had a chest X-ray, blood tests by his primary care physician and heart doctor. Had blood tests by his oncology doctor. All of those came out normal, with no problems. Feel free to ask for those results. No other additional vaccines were administered on Same Date of the Pfizer Suspect. The patient has not received any other vaccines within 4 weeks prior vaccinations. The adverse event shortness of breath resulted in visit to urgent care and physician office. The patient underwent lab tests and procedures which included chest x-ray: normal on an unspecified date. Therapeutic measures were taken as a result of the adverse events. The outcome of the events was unknown.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the events "Dyspnoea, Nasal congestion ,Cough, Chest discomfort " and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in re-sponse, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Cough; Soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 80-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 at 12:30 (at the age of 80-year-old), as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation, bypass surgery, mitral valve replacement, chronic obstructive pulmonary disease (COPD) and COVID-19 and hospitalisation (due to COVID-19) in Dec2020 and did not suffer as much pain and discomfort as the side effects. The patient was not aware of any known allergies to medications, food or other products. Concomitant medications included warfarin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and torsemide (TORSEMIDE), all medications received on unknown date for unknown indications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced cough and soreness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events cough and soreness at injection site was resolving at the time of reporting. No follow-up attempts are needed. No further information is expected.

EMS brought patient to ED stating patient was bright red and tachypneic with oxygen saturation of 81-82% on RA. Failed on CPAP. Given Benadryl 50mg IVP, Solumedrol 125mg IVP, 0.3mg of IM Epi and a duoneb with no relief. Was RSI'd and intubated and transported to the ED.

Patient had full body hives starting on 1/25/2021 (mainly on arms) Hoarseness in throat and congestion Child treated with Benadryl Advised treatment from PCP was/is as of 1/28/2021 Zyrtec 10 mg AM + pepcid 20 mg AM Zyrtec 10 mg PM + pepcid 20 mg PM Limit benadryl but if give it then only at night and replace it for the zyrtec

10 days after the first injection a red rash appeared, covering both feet and extending up the body to the armpits. Nothing on the neck, face or head; very little on the back but heavy on the front torso. (I have pictures). Not painful or itching. Took Benedryl for 2 days, no change. Dr. prescribed Fluocinonide Cream .05% on Feb 4. Have applied one dose and will continue doing that. Urgent care suggested that the site location personnel need to be contacted. He is scheduled for Feb 11 to get injection #2. Should he or not?

not feeling well/feeling unwell; aches all over his body/Aches all over with muscles pains; muscle pains; headache; joint pain; chills; Injection site pain on left arm; body slightly warm/felt slightly warm; This is a spontaneous report from a contactable consumer (Patient's wife). A 81 years old male patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3247 or EL3427), via an unspecified route of administration at Arm Left on 21Jan2021 09:33 at the 81 years old at single dose for COVID-19 immunization. The medical history was none. The family medical history was none. The concomitant medications included warfarin from Mar2012 for Atrial fibrillation( AFib) and standard medications . The patient was not feeling well. All occurred on 21Jan2021 18:00, the patient developed symptoms, such as aches all over his body, aches all over with muscles pains with muscle pains, headache, joint pain, chills, injection site pain on left arm, body slightly warm, felt slightly warm, feeling unwell. He had chills all night and could not get warm. The reporter had not taken the patient's temperature yet. The patient takes regular medications. The patient was on warfarin and standard medications. The reporter stated the vaccine cards were mixed up because they did not write their names on them and the vaccine lot numbers looks like they were mixed up. Someone probably made a mistake because one says EL3247 and the other says EL3427, so she is not sure which it is. The handwriting is different on the cards. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect. There was not Emergency Room Visit or physician's office required Prior Vaccinations (within 4 weeks). The outcome of the event was not recovered.

Brain fog; anxiety; (minor) sudden brief sharp headache; soreness at injection site; This is a spontaneous report from a contactable consumer reporting for self. A 81-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EL9261,via an unspecified route of administration on 19Jan2021 15:30 (at the age of 81-years old), Dose 1, as a single dose, left arm for COVID-19 immunization. Medical history included high cholesterol and hypothyroidism. The patient had not been diagnosed with COVID-19 prior to vaccination. Concomitant medication included levothyroxine, guaifenesin (ROBITUSSIN), and rosuvastatin calcium (CRESTOR). The patient did not receive any other vaccinations in the 4 weeks prior to the COVID-19 vaccination. On 19Jan2021 at 15:45, the patient experienced brain fog and anxiety, which lasted approximately 20 minutes. Also (minor) sudden brief sharp headache and soreness at injection site. There was no hospitalization for the events. The patient received treatment for the events, reported as "Calming talk, deep breathing, rest." The events were reported as non-serious. The patient recovered from the events brain fog, anxiety on 19Jan2021 at 16:05 and recovered from sudden brief sharp headache and soreness at injection site on unspecified date(s). The patient had not been tested for COVID-19 since the immunization.

Swelling, redness, warm-to-the touch on vaccinated arm beginning 7 days after vaccination. Reaction occurred on entire upper arm and did not begin at injection site. Pt did not experience any initial swelling or soreness at injection site.

Sore injection shoulder extending to the other shoulder; 2 degree temperature; chills. Lasted about 24 hours. I also had some scattered, small red bumps over my arms and legs and several tender bumps on my head. The toes on my left foot had a reddish appearance. These symptoms lasted about 5 days and may or may not be related to the vaccination. At my age, random unexplained symptoms are not unusual.

Pain at injection site; muscle pain below injection site; severe bruising below injection site; This is a spontaneous report from a contactable consumer reporting for himself. An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL8982, expiry date unknown) on 16Jan2021 15:30 at a single dose via an unspecified route of administration in his left arm for COVID-19 immunization. Medical history included diabetes, heart disease and arthritis, from unknown date and unspecified if ongoing. The patient had known allergies to penicillin and tramadol hydrochloride (ULTRAM). The patient's concomitant drug included apixaban (ELIQUIS), no other vaccine received in four weeks. The patient had not had COVID prior the vaccination and no COVID tested post the vaccination. On 16Jan2021 (time provided as 22:00), the patient experienced pain at injection site, muscle pain below injection site, severe bruising below injection site. The patient took apixaban and he believed the injection caused severe bruising. The patient received home remedy: elevated arm applied warm compress, as treatment for the events. The patient was recovering from the events.

Herpes zoster on right side; shortness of breath after vaccination. Seen in office 2/9/21. Chest x-ray completed, patient prescribed valacyclovir, prednisone, tramadol. Patient reports improved breathing and pain 2/10/2021 since beginning treatments

feet and lower leg became very red and very itchy in the night. by morning only toes blotchy red and itch gone.

Rash started on back, spread to stomach, chest, down arms 10 days after shot. Went to dermatologist and was given Triamcinlone 0.1% cream 454 gm to apply 2x/day. Appearance of rash has been reduced but is still present. Was told by IVIG nurse to report symptoms.

Registered Nurse Progress Notes Signed Encounter Date: 2/17/2021 Signed Hide copied text Hover for details Pt reports rash to arms, legs, and back with itching after first Pfizer vaccine, lasting 2 weeks. Pt took Benedryl BID for relief. Pt states, "I have an appointment with my dermatologist tomorrow to get advice on a potential response." Pt refuses a 30 minute wait. He wants to leave after 15 minutes. Electronically signed by RN at 2/17/2021 3:25 PM

Patient says that he has dermatitis; Rash; This is a spontaneous report from a contactable pharmacist and physician (patient himself). An 81-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: EL9261, exp date: May2021), via an unspecified route of administration on the left arm on 22Jan2021 15:30 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications reported as none. The pharmacist was calling to report that her father who had the Pfizer COVID-19 vaccine has a rash, a lot of a rash, after his first dose on 22Jan2021. No treatment was done for the rash. The pharmacist stated that her father though that the rash was a virus reaction. Patient (father) abruptly takes over the phone call and confirmed that he was the patient. Patient stated that he has dermatitis (this was a virus reaction) on upper and lower limbs for two days after the injection of vaccine (at night for 3 hours every night). The patient stated it was a virus reaction and he was dermatologist, a dermatology specialist, he has been for 50 yearrs experience. Patient stated it was a slight reaction, 2-3 hours of rash and physical reaction. Outcome of the events were unknown.

Day after vaccine given, large red bump appears over RIGHT eye. Then non stop throbbing headaches (still up til today), teary eyes. Then on 2/25/2021 very large (size of half dollar coin) red bump appears over LEFT eye. VERY swollen shut. Hurts, throbs and itches. Took photos and having tele med call with physician today at 1:50 pm. More bumps appearing higher up on scalp and skin on bump is red and pealing. Very swollen L. eyelid and swollen under eye as well. Hot to the touch. Bumps coming and going behind left ear.

injection site swelling; heart rate increased (95 bpm); jumping heart rhythm; Weakness; coughing while trying to take a full breath; sore right arm; This is a spontaneous report from a contactable consumer reporting for himself. An 81-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EN6201), via an unspecified route of administration in the right arm, on 11Feb2021 at 11:45, at single dose, for COVID-19 immunisation. Medical history included ulcer haemorrhage, ongoing arthritis, blood pressure abnormal, coagulopathy, surgery (for his chronic arthritis in the neck and shoulder), cardiac disorder (with heart aneurysm and a murmur). Concomitant medications included indapamide (unknown manufacturer) for blood pressure abnormal, acetylsalicylic acid (ECOTRIN 81 MG) for anticoagulant therapy, potassium (unknown manufacturer), candesartan (unknown manufacturer) for blood pressure abnormal, clorazepate dipotassium (TRANXENE) for muscle relaxant therapy for his chronic arthritis in the neck and shoulder. The patient experienced jumping heart rhythm on 15Feb2021 with outcome of not recovered, weakness on 15Feb2021 with outcome of recovered, coughing while trying to take a full breath on 15Feb2021 with outcome of recovered, sore right arm on 11Feb2021 with outcome of recovering, injection site swelling on an unspecified date with outcome of unknown, heart rate increased (95 bpm) on 15Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included heart rate: 95 bpm on 15Feb2021, prostatic specific antigen (PSA): unknown result on 03Feb2021. Therapeutic measures were taken as a result of sore right arm and included treatment with Tylenol.

Post 2nd Pfizer vaccination side effects FYI, my body temperature averages between 97.1 and 97.5 the year around. On Wednesday, February 24th at 10:45am I received my 2nd Pfizer Covid shot with no immediate side effects. Later that night there was some soreness at the injection site.The next day the injection site was tender with skin tight. ------------------------------------------------------- On day 1, February 25th after my 2nd Pfizer Covid-19 vaccination It was a normal day with soreness at the right arm injection site only On day 2, February 26th, after my 2nd Pfizer Covid-19 vaccination Another normal day with some soreness at the shot site. On day 3, a

he tested COVID-19 positive; he tested COVID-19 positive; fever and chills; fever of 100.5; takes all his energy to walk around or eat or do anything; injection site turned red and sore; injection site turned red and sore; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 15Feb2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL2347), intramuscularly, in the left arm, on 29Jan2021 at 11:00 at single dose for COVID-19 immunisation. Medical history included esophageal cancer from 2020, had major surgery from an unknown date about 4 months ago, and a third of his esophagus was taken out from an unknown date. There were no concomitant medications. No history if immunizations were provided. No other vaccines within 4 weeks prior to vaccination. The patient had the first dose on 29Jan2021 at 11:00 at a site sponsored by the health department, on 12Feb2021, it was reported that patient tested COVID-19 positive. On 31Jan2021, the patient reported that he had chills and a fever of 100.5, a couple times his fever spike up and goes away. He does not want to do anything since it takes all his energy to walk around or eat or do anything. On 29Jan2021, after the injection, the patient reported injection site turned red and got sore. He is asking how long the symptoms last. The events did not require physician's office or emergency room visit. No treatment was given. The outcome of the events injection site turned red and sore was recovered while for the rest of the events was unknown. The patient was asking if he should get the second dose.

3-23-21 1PM PT STATES RT DELTOID IS PAINFUL X 2-3 DAYS - PAIN RELIEVED WITH ADVIL; 'NOT AS PAINFUL TODAY'. GOOD MOTOR, NEURO AND SENSORY NOTED. GOOD CAP REFILL. NO ACUTE DISTRESS. 3-24-21 9AM : PT STATES RT DELTIOD 'FEELS BETTER TODAY-STILL A LITTLE SORE'. DENIES ANY TROUBLE MOVING ARM.

Site: Pain at Injection Site-Mild, Systemic: Severe pain in right arm (non vaccine arm) with sever joint pain also-Severe, Systemic: Joint Pain-Severe, Additional Details: Severe pain in opposite arm with severe joint pain

Body rash spotty on both arms, but more extensive on midriff and groin; This is a spontaneous report from a contactable consumer. A 81-years-old male patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection) via an unspecified route of administration in Arm Left on 17Feb2021 at 14:00 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received other vaccine (first dose) in four weeks on 27Jan2021. On an unspecified date, the patient had experienced Body rash spotty on both arms, but more extensive on midriff and groin. Patient did not received any treatment. Patient did not tested covid post vaccination. The outcome of the event was not resolved. Information of lot and batch number has been provided.

Multiple blood clots, bleeding, hematoma, bleeding events after heparin, swelling in lower body, gangrene in both feet, double below knee amputation, situation ongoing, still in hospital.

Injection site pain; tiredness; chills; feeling unwell; administration date=02Feb2021, dose number=2/ administration date=16Jan2021, dose number=1; This is a spontaneous report from a contactable consumer (patient himself). A 81-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown, Expiration date: unknown), via an unspecified route of administration in left arm on 02Feb2021 at 14:30 at 14:00 at single dose for covid-19 immunization. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number unknown, Expiration date unknown), via an unspecified route of administration in left arm on 16Jan2021 at 14:00 as a single dose for covid-19 immunization. Patient's concomitant medications were not reported. Patient was not performed lab test. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 02Feb2021, the patient experienced On 02Feb2021, the patient experienced administration date: 02Feb2021, dose number:2/ administration date:16Jan2021, dose number:1 on 02Feb2021 14:00. Also, he had injection site pain, tiredness, chills, and feeling unwell on 03Feb2021. The outcome of event injection site pain, tiredness, chills, and feeling unwell was recovered on an unspecified date while for another event it was unknown. Information on the lot/batch number has been requested.

Shortly after the vaccine I developed red, burning hot feet which persisted off and on for about 3 months. My dermatologist diagnosed me with Erythromelalgia and perscribed Neurotin and finally within the last 10 days since the vaccination has the symptoms finally has seem to be getting better and are diminshing It generally occurs at night but happens periodically throughtout the day as well.

pain in chest; pain in neck and back; pain in neck and back; sneezes; Feels when muscles are contracting; felt a little nagging; Was like a very dull irritation in the right side of the neck. Was probably the lymph node; Was like a very dull irritation in the right side of the neck. Was probably the lymph node.; coughs; very mild sore arm; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm at the age of 81-year-old on 27Mar2021 (Lot Number: EP6955) as single dose for COVID-19 immunisation. Medical history included cancer from 2018 (started out with BCG treatments, where they insert bacteria into the bladder); Had another form of immunotherapy that didn't work too well for him and the cancer kept growing chemotherapy; Had a couple of operations and surgeries where the doctor removed it all but it came back. Best reaction was chemotherapy (It stopped the bleeding and was working on the cancer). Last one was 15Feb2021. Was getting blood work for every treatment. Had to miss one of the treatments due to low platelets. Has a chest port for treatments and blood work. Was very conscious before having chemo. It is kind of a rough thing to kill cancer but also kills good cells too. Definitely worked on killing the cancer for a while; the last treatment was 15Feb2021. Stage 4 was taking chemo. Had bladder cancer (which got out of the bladder and started spreading in to the lymph system), Height: used to be 5'7", is now maybe 5"4". The caller remarks that when he started with chemotherapy. he also lost a lot of weight. Weight: When he went in for last appointment it was 129 or 130 pounds. The patient's concomitant medications were not reported. The patient previously took chemotherapy nos from unknown date to 15Feb2021 for cancer. The patient experienced pain in neck and back on 28Mar2021, pain in chest on 29Mar2021. Caller stating that he and his wife had shot number one 27Mar2021 and are scheduled for second shot 20Apr2021. Wife had no symptoms, maybe a bit of a sore arm and he had the same reaction. Was a very mild sore arm in 2021. On day 2 or 3 on the right side of the neck, had felt a little nagging in Mar2021 and slight pain, especially when he moved and felt it around his back. It is just starting to go away now at 3 weeks. Around the back, around the perimeter and when he coughs in Mar2021, he can feel it in his chest. He is scheduled for the second shot. Is wondering if the second shot will have those symptoms. It's not like it is anything severe, it is just nagging. What worries is him, is that it lasted this long. Is a cancer patient and had last chemotherapy 15Feb2021. His oncologist said to go ahead and take the shot because he really needs the protection. It was asked what if he has the same reaction again. Will go on website but wanted to find out what other people are experiencing and whether or not to take the second shot. Wants to take it for protection. Really wants to take the shot on Tuesday. Pain in neck and back: Only when he coughs, is more of an ache. Started day 2 after vaccine on 28Mar2021. Was like a very dull irritation in the right side of the neck in Mar2021. Was probably the lymph node in Mar2021. Pain in chest: When he sneezes in Mar2021, there is a sharp pain, all around the perimeter of his chest. Is gone as soon as he stops coughing. Feels when muscles are contracting in Mar2021. Started day 3 after getting the vaccine on 29Mar2021. Stage 4 was taking chemo. Had bladder cancer, which got out of the bladder and started spreading in to the lymph system. Wants to be put on immunotherapy but can't until he is finished with his shots. If he gets the immunotherapy and if he has a reaction, would have to use steroids and they do not want to do that with the vaccine. The doctor wanted to start him earlier on the immunotherapy but thought it was important to get the vaccine first, that taken care of. The pain is only sharp if he lifts something. Otherwise, it is just dull. He knows it is there. It is not completely gone. This morning was the best that he had. Really got good sleep last night. The best since it has happened. When he sneezes, he can kind of feel it around his chest, just around the perimeter of the muscles. Treatment: The first couple of days, just put up with it. Took Tylenol one day and then on another day. Takes at bedtime. Does not like taking Tylenol because it effects his liver. If he doesn't need it, he doesn't take it. In the last week, every night he has been less and less bothered by how he slept. Last night he didn't even know he had it, the pain, and slept really well. Have not taken any meds, just Tylenol on day 4 and 5 to help sleep. Therapeutic measures were taken as a result of events. The outcome of events very mild sore arm, sneezes and feels when muscles are contracting was unknown. The outcome of other events was recovering. No follow-up attempts are needed. No further information is expected.

redness, swelling half way down to his wrist, itching and warm to the touch on the injection arm; redness, swelling half way down to his wrist, itching and warm to the touch on the injection arm; redness, swelling half way down to his wrist, itching and warm to the touch on the injection arm; warm to the touch on the injection arm; This is a spontaneous report from a contactable consumer (patient's partner). An 81-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9267), on 11Feb2021 (at the age of 81-years-old) at 2nd dose, single, administered in arm, for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included he took medications daily but nothing the reporter thought would be relevant. The patient previously received the first dose of BNT162b2 (lot number: EL8982) on 21Jan2021 (at the age of 81-years-old) at 1st dose, single for COVID-19 immunisation at grocery store. The patient was experiencing redness, swelling half way down to his wrist, itching and warm to the touch on the injection arm for one week, on 13Feb2021, after the second dose of the vaccine. The reporter wanted to know if this was associated with the vaccine because of the duration of the symptoms. He was having some kind of reaction for about a week. They wanted to report it, where he got the shot on that arm it went down the arm just past the elbow, it was red swollen and itching. Reporter confirmed they were seeking information about this reaction, if it was associated with the product to go on this long. It was about 2 days after the dose that he noticed the redness swelling and itching. It was pretty puffy, reporter thought it had worsened since it began. No investigation assessment was performed. The patient had not recovered from the events. No follow-up attempts are possible. No further information is expected.

hives; This is a spontaneous report from a contactable consumer or other non hcp (Patient himself). A 81-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in Arm Left on 01Feb2021 16:00 (age at the time of vaccination was 81-year-old) as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history, concomitant medications were not reported. Facility type vaccine: Doctor's office/urgent care. The patient has no other vaccine in 4 week. The patient has not tested covid prior vaccination and post vaccination.On 14Feb2021 The patient experienced hives. The outcome of event was unknown.

This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 at single dose in right arm for COVID-19 immunisation at the age of 81-year-old. Medical history included hypertension, atrial fibrillation. Concomitant medications included losartan, amlodipine, metoprolol, apixaban (ELIQUIS). Historical vaccine included first administration of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at single dose for COVID-19 immunization. On unknown date, blood cholesterol resulted a little bit high. On unknown date, the patient experienced little spot on arm got bigger and started to swell, It got worse, patient had red splotches down my arm, down my wrist, underarm, and then even on side of body; on the other arm a few spots, he had soreness in that arm, the patient might have shingles, doctor gave the patient medication (Unspecified Medication); it did not do anything, the splotches actually got a little bit worse, right arm has 3 splotches on it, one in muscle area on upper arm, down elbow is another red spot, right down the elbow another one; other one has a lot of them; It was getting a little bit itchy. The outcome of the events was unknown.

rash on all four extremities and trunk/he has a pruritic rash covering all 4 of his extremities and most of his trunk/scratchy/itchy sensation in the throat, rash and pruritus.; rash on all four extremities and trunk/he has a pruritic rash covering all 4 of his extremities and most of his trunk/scratchy/itchy sensation in the throat, rash and pruritus.; rash on all four extremities and trunk/he has a pruritic rash covering all 4 of his extremities and most of his trunk/scratchy/itchy sensation in the throat, rash and pruritus.; This is a spontaneous report from a contactable physician (patient). An 81-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 02Feb2021((at the age of 81-years-old) as single dose for COVID-19 immunization. The patient's medical history had diabetes. He was diagnosed his first year in medical school in 1968. Concomitant medications were not reported. The patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EL3246) on 12Jan2021 as historical vaccination as single dose for covid-19 immunization. On 03Feb2021 patient experienced rash on all four extremities and trunk/he has a pruritic rash covering all 4 of his extremities and most of his trunk/scratchy/itchy sensation in the throat, rash and pruritus. Clinical course of events: within 24 hours, after the patient had the second shot patient had no symptoms until late next day, then rash on all four extremities and trunk/ had a pruritic rash covering all 4 of his extremities and most of his trunk. It was not on his face. Then atter night, it got much worse next day. He states that he has taken a Benadryl and Pepcid which was helped with the itching but the rash has not gone away. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

All events took place: Following first dose, minor rash on left arm; following second dose, first developed severe rash on arm and belly, extreme fatigue, severe hiccups and inability to swallow without choking; ultimately developed liver and kidney failure, was diagnosed with DRESS syndrome resulting from reaction to vaccine, was administered high-dose corticosteroids and antibiotics but continued to decline, developed hemorrhage in lungs and died due to multi-organ failure. PDF Continuation field did not permit entering text, see attached Continuation Page.

Severe full body rash starting at neck and continuing to toes; This is a spontaneous report received from a contactable consumer, the patient. A 81-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 09Feb2021 (at the age of 81-years-old), as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration on 02Mar2021 at 11:30 (at the age of 81-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. Concomitant medications were not reported. The patient had not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced severe full body rash starting at neck and continued to toes. Therapeutic measures were taken as a result of severe rash and included treatment with prednisone. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome for the event severe rash was not resolved at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.

20 mts after vaccination when I was driving I suddenly starting feel an intense VIBRATION at the site of the injection(left up arm),then quickly extended to the whole limp and gained the right up limp after my lower extremities THEN my BRAIN and I was loosing vision.i told to my wife take the wheel and at that time EVERYTHING mean the intense vibrations including my sight came to normal.

Swollen lip; Hives near the groin area; This is a spontaneous report from a contactable consumer (patient's daughter). An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246), via an unknown route of administration, at single dose on 12Jan2021 for COVID-19 immunisation. Relevant medical history included gout and sinuses. The patient did not have relevant concomitant medications.On 12Jan2021, after vaccination, the patient had swollen lips and he thinks like hives on his thought near his groin, on the upper inside of his thighs on both sides, like hives, with swelling but not a rash. She said her father put hydrocortisone cream on his thighs and they were getting better. She said the lip swelling had not gone down, he took an allergy pill for that, he did not apply cream to his lips. She clarified that the hydrocortisone cream was brand Equate 1% Hyrdocortisone Maximum Strength Cream (UPC 319162ET4, Batch: 8JT0419, and EXP Aug2021). She reported that the allergy pill was generic Equate Allergy Relief (UPC: Unknown, LOT P121359, EXP Aug2022). The patient was recovering from the events.

Red mark on his shot mark; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: EL9262, via an unspecified route of administration in the right arm on 22Jan2021 at SINGLE DOSE for covid-19 immunization. The patient has no other relevant medical history. The patient's concomitant medications were not reported. The patient experienced red mark on his shot mark on 24Jan2021. The mark was not raised, and it is about the size of a pencil eraser. Patient does not have any feeling or pain (in this mark). The outcome of event was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

Patient received vaccine and after approximately 15 minutes he reported that his face felt swollen and was red. Reported that he has had this reaction before if allergic to something. Medical response called. Patient transported to ER via wheelchair by Medical Response team.

Vaccinated on Feb 2, slight pain in the side of injection for two days, Then on Feb 9 (5 days after injection) strong gradually increasing pain in R leg at hip and knee (medial side) - these parts were painful previously but not as strong pain as it is now. Using ibuprofen 200mg two tablets (400mg) twice a day with 80 % relief, strong pain during walk, but still worse during the night - difficult to find right position to reduce pain.

WOKE UP AT 3:00 A.M. WITH INTENSE PAIN IN ARM OF THE INJECTION AND SHIVERING. TOOK ACETAMINOPHEN AND BUNDLED UP. GOT UP ABOUT 9:00 A.M. AND TOOK IBUPROFEN EVERY 4 HOURS UNTIL BEDTIME. WAS SORE, COLD AND ACHEY FOR REST OF DAY. SLEPT GOOD THAT NIGHT. IT WAS ALL OVER WHEN I WOKE UP THE SECOND MORNING AFTER INJECTION

Patient bruised immediately upon receiving the vaccination. A small hematoma formed around the injection site. Patient iced the area while waiting in the waiting area. She stated that this had happened before when receiving a vaccination and was not under any distress or experiencing further symptoms.

Right arm achy/a little achy/only his arm was achy/arm only hurt when he was lying on it; Right ear ache and bumps around ear lobe/ear started hurting/earache/behind his ear started hurting. Going online and believes irritation could be from the masks worn for COVID-19.; Back of his ear was red and swollen/around left ear lobe it is bump and red; Back of his ear was red and swollen/around left ear lobe it is bump and red; Back of his ear was red and swollen/around left ear lobe it is bump and red; Tingling to his ear; lesions are at the top of his ear near his hairline; This is a spontaneous report received from a contactable consumer (patient). An 82-year-old male patient received the first shot of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 11:10, at single dose, for COVID-19 immunization/Want to live, at the hospital. Medical history included being allergic to cats; had triple bypass and valve, had allergies his whole life and had shrunk. Concomitant medications included unspecified allergy pills which the patient takes all year round. The patient previously took amoxicillin and reported that he was immune to it and it did not work; reported that he has taken azithromycin before when he goes to the dentist he has to take azithromycin. On 25Jan2021, the patient took his first COVID-19 vaccine shot. On the same day, the patient was a little achy. He took Tylenol every 5 hours afterwards and iced it and then had had no problem. He woke up the next morning (26Jan2021) perfectly fine. The patient clarified that only his arm was achy, his right arm was achy, and it only hurt when he was lying on it. But then on Wednesday night or Thursday morning (Jan2021), the patient had tingling to his ear and the back of his ear was red and swollen. He reported that "behind his ear started hurting". He also had right earache and bumps around ear lobe. He reported he had little bumps or lesions which were at the top of his ear near his hairline. The patient went to his pharmacist to get their opinion and was given Aquaphor ointment for pain relief, but he reported that it made the area behind his ear worse, so he went back to using the antibiotic ointment and stated that "the cold pack helped the most". The patient reported had doctor's appointment on 01Feb2021 at 12 and the doctor gave him azithromycin tablets, 6 tablets. He also reported that he has an unopened box of Azithromycin tablets USP which he has not taken and will not without doctor's permission. He went online and believes this irritation behind the ear could be from the masks worn for COVID-19 and stated that the KN-95 masks were kind of tight. He stated he now has the thing on the back of his neck to help with the mask. The patient also reported that he doesn't have fever or temperature and he has no cold. The patient was scheduled to receive his second shot two weeks from the time of the report and wanted to know if he can take antibiotics and then get the second shot. The patient recovered from pain in arm on 26Jan2021; and has not recovered from the remaining events.; Sender's Comments: Event ear pain represents an intercurrent medical condition and unrelated to BNT162B2 .

Skin rash-first Noticed 3 days after shot. Red spots front and back upper torso and down arms. Some redder with white pinpoint spot on surface. Called My Nurse. Advised using cold packs for itching and call Medical doctor after weekend. Called Dr Tuesday, Mar 2, and went in to office. Saw PA. She confirmed a reaction to Covid shot and prescribed Prednisone 20 mg two tablets by mouth for 10 days. Said to call and get another prescription for it 10 days before 2nd shot March 25. Wednesday, Mar 3, -still has rash.

1)Intense blood swelling 2) Dryness 3) Itchiness that is causing big dark red spots all over the body 4) Exactly looks like fungal infection

- covid shot Thursday at 1445 - upper lip swelling at 1730 Thursday - Friday fine til evening and was complaining of itching - Saturday morning red raised areas that were itchy on back, buttocks, and back of thighs. Denies discharge. - today better, areas still there, but lighter in color and has not complained of itching so far.

wasn't able to sleep; felt like he was in a refrigerator; shaking; lower back pain; The patient reported receiving the Pfizer vaccine in his right arm; right arm/shoulder pain; right arm/shoulder pain; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 06Feb2021 at a single dose on the right arm for COVID-19 immunization. The patient also started to receive mirtazapine (MIRTAZAPINE, 50 mg, Capsule, soft), via an unspecified route of administration, from an unspecified date at 50 mg, once a day for sleep. Medical history included sleep (disorder). Concomitant medications included aspirin [acetylsalicylic acid], calcium, escitalopram, finasteride, lamotrigine, simvastatin, tamsulosin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), on an unspecified date for COVID-19 immunization. The patient reported receiving the Pfizer vaccine in his right arm on 06Feb2021. That evening he took his nightly medication and went to bed at 11:30 pm. He stated he wasn't able to sleep because he felt like he was in a refrigerator and he was shaking. He had lower back pain, right arm/shoulder pain, and went to the bathroom 5 times (all on an unspecified date in Feb2021), which was not normal for him. The patient added that it was the second dosage of the Pfizer (Covid-19 Vaccine) her received on 06Feb2021. And he had some negative response: a little pain in his shoulder but the worst thing that happened, he went to bed 11:30 did not sleep at all. At 11:30 night, he took his medication (Mirtazapine) and went to bed. He was shaking and he had to put another blanket on himself. Eventually, it was okay, but the problem is he was not able to sleep all night, from 11:30 to 9' O clock this morning (07Feb2021). Consumer stated, "Yesterday my wife and I had the second dose of the Pfizer and I had really strange reaction and I will tell you what it was. Last night at about 11:30 I took my night medicine (later clarified as Mirtazapine), I went to bedroom, I started shaking all over. And the worst part is from 11:30 to 10 o' clock this morning, I was not able to sleep. There is slight pain in my shoulder". When confirmed if the consumer wanted to report the same or have any questions, consumer stated, "No, we have no problem with temperature is fine, the oxygen is fine. Just I don't understand why in fact the medication (mirtazapine) is to induce sleeping, use to for sleep within half hour but it didn't help. I wanted to know what happened. So, this will eventually go away?" The action taken in response to the events for mirtazapine was unknown. Outcome of the events was unknown. Information on batch number has been requested.

Pemphigus; blisters over upper body; This is a spontaneous report from a contactable physician. An 82-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration on left arm on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included glaucoma, AMD and arrhythmia. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), rosuvastatin calcium (CRESTOR) and timolol. The patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: lot number: EL 1284 on left arm) on 30Dec2020 for covid-19 immunisation and experienced hives in the back. The patient experienced pemphigus and blisters over upper body on 18Feb2021 12:00. The patient underwent lab tests and procedures which included Skin Bx: confirm pemphigus on an unspecified date. Therapeutic measures were taken as a result of pemphigus and blisters included prednisone. Outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events "Pemphigus and blisters over upper body" cannot be completely excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

After vaccine, the next day I got up and my feet were red and swollen from ankle down with small blisters on top of my feet that lasted from 3/10 through 3/14, it's not 100% gone but most is gone today. I went to the Urgent Care Clinic and the doctor said it will go away, I took Benedryl. They tested me for Coronavirus and it was negative.

Pemphigus; Hives in the back; This is a spontaneous report from a contactable physician (patient). An 82-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL 1284), via an unspecified route of administration, on the left arm, on 30Dec2020 at a single dose for Covid-19 immunisation. Medical history included glaucoma, age-related macular degeneration (AMD), arrhythmia. The patient has no known allergies. The patient did not receive other vaccine in four weeks. The patient has no Covid prior vaccination and not Covid tested Concomitant medications included nebivolol hydrochloride (BYSTOLIC), rosuvastatin calcium (CRESTOR), and timolol. On an unspecified date, the patient developed hives in the back within a week after 1st shot and broke out in blisters over upper body 3 wks after 2nd shot of vaccine. Skin biopsy (Bx) done to confirm Pemphigus. Treatment for the events was Kenalog 60 mg IM/ also 3 wks later prednisone po. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event Pemphigus cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.

"very dark red, big, angry rash" on the back of both of his hands that is moving up his arms, which the caller describes as "erythema multiform"; This is a spontaneous report from contactable consumers (one is the caregiver). An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date were not reported), via an unspecified route of administration on 23Feb2021 (at the age of 82-year-old) at single dose for COVID-19 immunization. Medical history included cancer, stage 4 renal cancer with metastasis to the lung, kidney failure and being dialyzed, electrolyte imbalance, prostate infection, blood pressure abnormal. Concomitant medications included prednisone for kidney failure; sevelamer carbonate (RENVELA) to regulates his electrolytes; hydralazine (HYDRALAZINE) for blood pressure; candesartan for blood pressure; metoprolol succinate (TOPROL) for blood pressure; finasteride for prostate; and amlodipine. The patient developed a very dark red, big, angry rash on the back of both of his hands that is moving up his arms (reported as worsened), which the consumer describes as "erythema multiforme". Looks like erythema multiform is this rash associated with the product very dark red, big angry splotches very large. He was told he should get the vaccination, his oncologist and his nephrologist said he should get it so he got the vaccination last Tuesday and then he woke up either the next day or the day after that and her mother said he had a very severe rash on his hands and now it is climbing up his arms. It almost looks like erythema multiforme but it has no bulls eye, It is dark red and ugly looking it is rough, it is not really raised. They went to the oncologist and they took blood work to make sure his platelets were okay and they were normal so his doctors are baffled with this. She is calling from her husband's surgery office and they are disgusted with the healthcare he is receiving there but she wants to know if there is any data with cancer patients taking the vaccine or with people that have developed a rash like she is describing. His weight has dropped a lot since she last saw him he is 5'10", now he is probably about 150 or 160 lbs. That is an estimate. He developed the rash either 24Feb2021 or 25Feb2021, she is not sure which. It was ongoing and it is actually spreading up his arms so she would say it is worsened. He is on a slew of medications, but she doesn't know if they want all of them. It could be an interaction with medication, he is a really sick person. The outcome of the event was not recovered. Information on lot number/batch number has been requested.

Patient received his first dose of Pfizer COVID-19 vaccine on 02/03/2021. He has significant medical history, but presented to the hospital on afternoon of 02/08/2021 with report of three days of nausea and vomiting. He thought this attributed to a new cholesterol medication. He also reported some shortness of breath, mild cough, no fever. reported some epigastrium pain the day prior but since resolved. Significant other reported some significant swelling and that pt complained of feeling like he had a "blockage in his throat". Workup showed concerns of pneumonia so pt was started on antibiotics and Vitamin K. Shortly after meds started pt started complaining of itching arm and trouble breathing. He became bradycardic and lost consciousness. Resuscitative efforts initiated but unsuccessful. Time of death called on 02/08/2021 at 1737. Hospital notes report "cause of death is anaphylaxis", and pt would be an OME case.

interface dermatitis; This is a spontaneous report from a contactable Physian. A 82 years male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number:unknown), via an unspecified route of administration, administered in Intramuscular left arm on 11 Feb 2021 at the age of 82 years old as single first and second dose for COVID-19 immunisation. Patient medical history included COPD and decreased renal function. concomitant medications were not reported. Patient was allergie to IVP contrast dye. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18 Feb 2021, the patient had experienced Skin eruption distal feet (incl. toes), both palms, both knees. Biopsy reveals interface dermatitis. At the time of reporting, the event was recovering/resolving. Information about lot/ batch number has been requested.

red, itchy rash.; itchy rash./broke out in an itchy rash on his waist, back, shoulders, chest, and neck.; This is a spontaneous report from a contactable consumer, caregiver/wife. An 82-year-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine, solution for injection, Lot Number: EL9263, Expiry Date: Unknown, NDC number: unknown) via an unspecified route of administration on 24Jan2021 at 11:30 on right arm as a single dose (at the age of 82-years) for COVID-19 immunization. Patient's Medical History (including any illness at time of vaccination): None. Family Medical History Relevant to AE(s) was not provided. Patient used no other products. No vaccines administered on same date of the Pfizer suspect. Patient did not receive any prior vaccinations (within 4 weeks). Caller stated that she was calling on behalf of her husband (name) who received the first dose of Pfizer COVID vaccine on 24Jan2021. Caller stated on 02-03Feb2021 (a week and a half later after receiving the vaccine) her husband developed a red, itchy rash on his waist, back, shoulders, chest, and neck. She said her husband did not have a rash on his arms, legs or face. Patient did not require a visit to emergency room but visited physician office (Primary Care Doctor and Allergist). Reported her husband's allergist did a bunch of allergies testing and all the test results were negative. Her husband's doctor gave her husband a couple of injections. She said she knew one of the medications started with "Dexa", saying the medication was something like Dexatrim. She said she did not know what the other medication's name was. Her husband had taken some over-the-counter Benadryl. She said her husband is no longer taking the Benadryl. She did not have the Benadryl UPC/NDC, Lot, and Expiration Date. Reported her husband was using over-the-counter cream, clarified as Sarna cream. She said the Sarna cream was a white cream and was helping her husband's itch and rash. She said she did not have the Sarna cream with her to provide the UPC/NDC, Lot and Expiration Date. Caller stated her husband is due for his second COVID-19 vaccine and wanted to know if Pfizer recommended her husband get the second COVID-19 Vaccine dose. She reported that her husband's primary care doctor and allergist both recommended her husband not take the second COVID-19 Vaccine dose. Outcome of the events was recovering. Investigation Assessment: Yes. No further details provided.

Chills; very itchy episode; Runny nose; This is a spontaneous report from a contactable consumer, the patient via PPDi. An 82-year-old male patient received first dose of BNT162B2 (BioNTech COVID 19 vaccine, solution for injection, lot number: caller could not locate the lot number, NDC number: Unknown, Expiry Date: Unknown) on 11Mar2021 at 13:00 as a single dose for COVID-19 immunization. Patient took the second dose on 01Apr2021 at 1pm (unknown NDC number, for lot number and expiry date: caller could not locate the information). Caller stated both doses were received in the left arm. Patient had no family and medical history. Patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. Patient did not receive any prior vaccination (within 4 weeks). relevant to AE(s). There were no AE(s) following prior vaccinations. For concomitant products caller stated "no" because he took his regular medication from his primary care doctor. Caller clarified that the antibody test was given at the church and he was given the number to find out results of the COVID-19 antibody test, which was 2 weeks before the first dose. Caller stated the antibody test was not Pfizer. He got a telephone number (Withheld) that he called which was who told him the results for not being exposed to the virus. Caller stated he was not exposed to the virus and decided to follow up to get the Pfizer vaccine and he received the first dose on 11Mar2021 and the second dose on 01Apr2021. Caller stated he was calling about the BioNTech COVID-19 vaccine. Caller stated he took the shot at Church. The runny nose started a day or two before the first shot, he clarified it was around 10Mar2021 this started, which was still ongoing. Caller stated he was experiencing a very itchy episode right after the first shot of the COVID 19 vaccine which was on 11Mar2021. Caller stated those are the two items he was complaining about. Caller stated chills started in between the two doses. Caller stated it is not going on now but sometimes early in the morning when he woke up and until he got the temperature up in his apartment, he experienced chills. Caller stated if the heat was on, he does not noticed chills but if the heat was not on, he does notice it. The temperature is in the high number and he had a little chill right now while speaking. Caller stated the outcome is the same. Patient took one except for Tylenol. He has taken a couple of Tylenols, he clarified he had just been taking tablets of Tylenol for chills. Outcome of the events very itchy episode was not recovered while that of chills and was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Fever Cellulitis Elevated troponin Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present"

No access to SIH documentation: 4/6/21 Occult blood positive - Cancer Center 4/27/21 Dx Melena, Medical Center, VCE, EDG/upper enteroscopy and colonoscopy discussed / ordered? - wife cancelled? 5/17 ER - Admission: falls, bruising abdomen, pelvic area, right back, buttock - Hospital 5/29/21 ER - Admission: The patient is a 82 y.o. male with a PMH notable for uro lift on 05/26/2021, BPH, CAD, diabetes, atrial fibrillation, hypertension, and CABG who presented on 5/29/2021 for evaluation of catheter problems. Patient presented to our emergency room with complaints of leaking around his catheter. Patient had a uro left done on Wednesday 05/26/2021. Wife and patient stated they went back yesterday due to the catheter was clogging up with clots and they replaced catheter. Patient stated he has been urinating clear but around the catheter and none has been going into his leg bag. Patient wife states that he has not taken his diuretic all day because he was worried about taking it since urine was not going into the Foley catheter bag. Upon arrival to the emergency room patient's temperature 98°, pulse 83, respirations 18, blood pressure 153/77 oxygen saturation 100%. Hemoglobin 8.8, glucose 285, BUN 24, sodium 134, INR 1.3, BNP 1460, urinalysis has culture pending. The emergency room called Dr and he requested that the patient be placed in observation here to assure that anemia is not worsening, CHF improves and patient is able to void on his own without retention. Patient received Lasix 40 mg IV push in the emergency room. Patient was admitted observation status for further treatment and evaluation systolic congestive heart failure, acute post hemorrhagic anemia, anticoagulant induced hematuria. Upon entering the patient's room this morning patient is resting in bed in no acute distress. Patient is alert and oriented x3. Patient states he is voiding without any difficulty from having Foley catheter removed. Patient states he came to the ER because he did not take his diuretics due to he was peeing around the catheter and then of his urine was going in Foley catheter bag. Patient denies any increase in shortness of breath, chest pain or any weight gain. Explained to patient that he is going to be here for the next day receiving IV diuretics to see if we can get swelling decreased on bilateral lower extremities and to continue monitoring his urine for blood and checking his hemoglobin. Rounds made with another Dr.

Develop rash front of his left arm the injection on the side, the rash is on front kind of even where the injection was given; Pain in his left arm; Started having a lot of pain in his shoulder, left elbow and it radiated down into his finger; Started having a lot of pain in his shoulder, left elbow and it radiated down into his finger; Started having a lot of pain in his shoulder, left elbow and it radiated down into his finger; Left elbow swelled; This is a spontaneous report from a contactable consumer (patient's wife). A 82-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL9261), via an unspecified route of administration, administered in arm left on 04Feb2021 (at the age 82-years-old) as 2nd dose single for COVID-19 immunization. Medical history included hypertension (20 Years ago, patient don't know the exact date, at least 20 years ago), cardiac pacemaker insertion from Feb2020, bypass heart surgery on an unspecified date in 2006, neuropathy (patient did not remember its diagnosis date, patient only had bypass and to put in 2 stents). Concomitant medications included hydrochlorothiazide (Tablet) (MANUFACTURER UNKNOWN), orally on an unspecified date at 50 mg (25 mg, 2 tablets per day) daily for hypertension; metoprolol (MANUFACTURER UNKNOWN), orally on an unspecified date at 25 mg twice a day for unknown indication; duloxetine (MANUFACTURER UNKNOWN), orally on an unspecified date at 30 mg once a day for unknown indication; hydralazine (MANUFACTURER UNKNOWN), orally on an unspecified date at 50 mg thrice a day for unknown indication; furosemide (MANUFACTURER UNKNOWN), orally on an unspecified date at 80 mg once a day for unknown indication; rivaroxaban (XARELTO) (MANUFACTURER UNKNOWN), orally on an unspecified date at 50 mg once a day for unknown indication; ezetimibe (MANUFACTURER UNKNOWN), orally on an unspecified date at 10 mg once a day for unknown indication; clopidogrel (MANUFACTURER UNKNOWN), orally on an unspecified date at 75 mg once a day for unknown indication. Vaccination Facility at the doctor's office. The patient experienced started a lot of pain in shoulder, left elbow and it radiated down into finger on an unspecified date in 2021. 3 days age develop rash front of left arm the injection on the side, the rash was on front kind of even where the injection was given on 14Mar2021 (reporter stated that, read moderna (not clarified) had a problem with rash). Pain in left arm on an unspecified date in 2021. Event start date, it would had couple of weeks after the 04Feb2021 and patient had the rash right now. Probed for events start date, reporter stated, That one was about two weeks ago, everything was in left arm. When probed still having the problems (event), reporter stated, that was better but yes patient had still left, it improved but patient still have it, it progress started about 3 days ago. On an unspecified date, the patient underwent lab tests and procedures which included blood test they were fine, patient was almost fine had routine blood work done but now had not anything. Any treatment for the event, reporter stated, For the rash patient not had any treatment for, the pain in arm and everything the orthopedic doctor gave a shot of cortisone to see if that might have (treatment) and that was on 01Mar2021. When probed for cortisone dose (treatment), reporter stated, I have no idea, I don't know about that. Patient probed for cortisone dose (treatment), reporter had no idea and do not know about that. When probed for cortisone shot (treatment) site of injection, reporter stated, would be on left shoulder and frequency, just once. The clinical outcome of the event pain in arm was recovering and rest of the events were unknown. No follow-up attempts are possible. No further information is expected.

Injection site pain; Injection site pain and swelling; Fatigue; Chills; Fever; Muscle and joint pain; Muscle and joint pain; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. An 82-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 05Mar2021 at 14:00 (at the age of 82-years old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Mar2021 at 18:00, patient experienced injection site pain and swelling, fatigue, chills, fever, muscle and joint pain, loss of appetite. The patient underwent lab tests and procedures, which included PCR (nasal swab) on 15Mar2021 and tested negative. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events vaccination site pain and vaccination site swelling, fatigue, chills, fever, muscle pain, joint pain and appetite lost was recovering at the time of this report. Information on the lot/batch number has been requested.

Rash: all over his body, like measles, on his back, arms, and legs/ terrible measle like rash all over my body except for my face; The itching was so bad that I scratched myself to the point of drawing blood; Itching, worse itching he ever experienced/ intense itching all over my body/worse itching/ itching was so bad; they called it, Dermatitis.; he thought he was having a stroke.; This is a spontaneous report from a contactable consumer (patient). This is report 1 of 2. An 82-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6208; NDC/expiration: unknown) via an unspecified route of administration, administered at arm right on 22Mar2021 at 10:00 (at the age of 82-years-old) as dose 2, single for covid-19 immunization. Medical history included ongoing high blood pressure diagnosed many years ago, ongoing high cholesterol which was diagnosed around the same that his high blood pressure, ongoing type 2 diabetes mellitus diagnosed when he was in his 20's and he does not take any medications for his type 2 diabetes. The patient did not receive other products. No investigation assessment was reported. He stated several family members had the Moderna Covid vaccine, and they had some negative reactions. There were no additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any prior vaccinations (within 4 weeks prior to the COVID vaccine) and no adverse events were reported following prior vaccinations. Family medical history relevant to adverse event was not provided. His other family members had flu like symptoms, and they were all females. 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 received within 2 weeks of vaccination included rosuvastatin calcium (CRESTOR); losartan (LOSARTAN); propranolol; primidone (MYSOLINE) and acetylsalicylic acid (ASPIRIN (E.C.)) all taken for an unspecified indication, start and stop date were not reported. He had been taking the same medications for years and never had any negative reactions. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot: EN6200; expiry date: unknown), via unspecified route of administration, administered on right arm on 01Mar2021 at 10:00 for COVID-19 immunization. The patient experienced terrible reaction 3 weeks after the second vaccine. He woke up in the morning, turned on light and saw that he had rash all over his body (except for face), like measles, on his back, arms, and legs, intense itching all over body, worse itching he ever experienced in his life on 11Apr2021. The itching was so bad that he scratched himself to the point of drawing blood. He thought he was having a stroke. When he went to urgent care, he was treated with 2 injections Benadryl and steroid (Lot or expiration date was unknown). He was also treated with Pepcid. The injections did not help his symptoms. In the urgent care they didn't knew what the rash was and later clarified that they called it dermatitis. He stated that the staff did not thought that it was not related to the vaccine. He reclarified that when he was at urgent care, the staff told him that he should feel better in the evening, but by midnight, he decided to go to the emergency room. In the emergency room, he was given Tagamet, Hydroxyzine, and Prednisone. The rash went away and reported that itching was present, but not as bad as it was before. He reported that he took Hydroxyzine as prescribed, and after about 20 minutes, his itching diminishes but then in the evening he started to itch again. Later in the report it was mentioned that for some days he only has to take it once a day and sometimes he can skip a day when he was not itching. He was treated and released from the emergency room. The patient went to dermatologist and neurologist and no one could tell him why he had itching, no one had come up with a treatment as he was still itching. The patient stated that he called because he was reading information about the side effects and learned that the vaccine may cause a rash. Relevant tests were reported as none. Device date was reported as 22Jun2021. The outcome of the rash was recovered completely in 2021, for scratch and pruritus was not resolved and for stroke and dermatitis was unknown.

A week after 2nd dose, I broke out in red circular somewhat itchy marks and oval welts ranging from small to about an 1" in diameter or length on arms,legs, back, chest.; This is a spontaneous report received from a contactable consumer, the patient. An 82-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via an unspecified route of administration in the right arm on 13Mar2021 at 09:30 (at the age of 82-years-old), as a single dose for COVID-19 immunisation. Medical history included occasional sciatica and some hearing loss. The patient did not have any known allergies to food, medications, or other products. The patient did not receive any other vaccine 4 weeks prior to COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the right arm on an unspecified date in Feb2021 at 09:30 (at the age of 82-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021 at 17:00, the patient broke out in red circular somewhat itchy marks and oval welts ranging from small to about an 1" in diameter of length on arms, legs, back and chest. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures included treatment with BENADRYL and calamine lotion (MANUFACTURER UNKNOWN). The clinical outcome of welts was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

twenty six hours after vaccine, hands started itching. Progressed to hive type rash from waist up. Also arms from elbows to hands. Face and eyes turned red. Fifty mg of Benadryl taken every six hours times three. This morning went to a walk in clinic . Was put on a Prednisone taper over 5 days.

Limited information as patient received vaccine at outside facility. During ED visit for unrelated issue patient report receiving the vaccine on 1/6/21 and started getting quarter sized blisters on his left hand the next day. Unsure if this was previously reported so submitting in case it was not. Patient resides at nursing home/rehab

Shortly after receiving the vaccine, the patient's spouse reported redness and swelling to the patient's face. The patient denied sensing any new symptoms. Vital signs within normal limits. He felt fine and declined urgent care.

Sore arm; I had a little bit of a rash on my shoulder; Back is full of pimples, red pimples, like red marks; Back is full of pimples, red pimples, like red marks and they itch; This is a spontaneous report from a contactable consumer (patient). This 83-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiry date unknown), via an unspecified route of administration on 18Jan2021 at a single dose for COVID-19 immunization. Medical history included high blood pressure, gout, and rash on the penis area. Concomitant medications included tacrolimus for rash on the penis area, allopurinol for gout, amlodipine for blood pressure, benazepril, hydrochlorothiazide, metoprolol, and unspecified vitamins. The patient has not had laboratory in the past two weeks but last month, and the everything was fine. On an unspecified date in Jan2021, the patient had sore arm. On an unspecified date in Jan2021, the patient noticed that he had a little bit of a rash on his shoulder but then he looked at his back and it is full of pimples, red pimples, like red marks and they itch. It is on the upper part of the back, around the middle. The patient did not take anything for said events. As they were on his back, he didn't notice them until last night (unspecified date in Jan2021), they started to itch a little bit. So, they could have been there for 2 or 3 days. The patient stated that the only thing he can think of is that it might be from the vaccine. Due date for the next shot is on 08Feb2021. Outcome of the events was unknown.

Day 1 after receiving vaccine he started to notice redness on face and fatigue. Day 2 woke up face was swollen and eyes almost swollen shut and hot, started taking benadryl and sleep most of the days. Denies SOB. Day 3 continue benadryl, zyrtec and pepcid. Day 4 came to PCP as it's gotten worst. Swelling of bilateral ears, face, and forehead.

Moderate pain and tenderness at injection site left deltoid area in 4-5 hours, followed rapidly with pain across back of neck to pain and tenderness over right deltoid area., all lasted just short of 24 hours

Day 1-1-1/2 Slight soreness at vaccine site; Days 2-3 Soreness throughout chest (as with the flu); Days 4-5 Soreness in left side of chest; Day 6 - present Soreness concentrated in one area of left chest/side; more intense and "takes my breath away," at times, with certain movement and total inflation or deflation of lungs.

2 days after 1st Covid vaccination my right arm at the site of the injection, the muscle became very sore and any exertion such as shoveling snow or lifting is very hard.. The muscle is always sore, even laying on my right side when sleeping is uncomfortable and will wake me up from sleeping

slight pain in his arm the shot was given; if he moved his arm, he would have slight discomfort; some slight tenderness in his shoulder; Yesterday, his temperature was 97 something. This morning, he got up at 6am and his temperature was around 98.8; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261; expiry date: unknown) via an unspecified route of administration in the left arm, on 26Jan2021 at 8:30 to 9 AM, at a single dose, for Covid-19 immunization. Medical history in Mar2020 included had a temperature for 7 days. He tested positive for COVID and it took a while to test negative. At the end of Mar2020 until the first of Apr2020, his temperature was 97 something. He has checked his temperature every day since then. There were no concomitant medications. The patient had no previous immunization with the Pfizer vaccine. He did not receive additional vaccines on the same date bnt162b2 was given. The patient had his first COVID-19 shot yesterday morning about 8:30 or 9:00. He hadn't really looked at the list of side effects, but yesterday afternoon (26Jan2021), he had slight pain in the arm where the shot was given. If he moved his arm, he would have slight discomfort. The pain was mostly gone today. He also had some slight tenderness in his shoulder, but it's certainly less than what it was yesterday. He saw other things that were listed including fever. He wanted to know if Pfizer had any information as what to amount of fever people typically experience after having the shot. Yesterday (unspecified date in Jan2021), his temperature was 97 something. This morning, he got up at 6 am and his temperature was around 98.8. And then he had to take his wife to therapy and when he got back 3 hours later, he took it now and his temperature was 99 degrees. He was just wondering if Pfizer had an idea of how much fever is normal from the shot? He hasn't had any other reactions. The events did not require Emergency Room or Physician's Office visit. The patient underwent lab tests and procedures which included body temperature: 97 something on 26Jan2021, 98.8 and 99 on 27Jan2021; sars-cov-2 test: positive on an unspecified date in 2020 and negative on an unspecified date in 2020. Outcome of the event "slight pain in his arm the shot was given" was recovering, while for the other events was unknown.

Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild

Received second dose on a Thursday. No immediate reactions to first or second dose other than very slight soreness at site of injection. On Saturday morning, however, following second dose, experienced moderate dizziness upon rising--had to hold on to furniture to maintain balance. Dizziness gradually subsided and was completely gone after 20-25 minutes. Additional note: several years ago experienced one episode of extreme benign postural vertigo, but experience after second dose of vaccine was milder and shorter in duration.

Awoke feeling achy, tired, warm, chills, headache on 3/2/21 Bright red rash down right arm , warm to the touch, swelling of arm and hand on 3/4/21 Arm Itchy and swollen, slowly dissipating since 3/4. Minor symptoms of arm and neck still today 3/8/21

Swelling and pain in the arm at injection site, plus Soreness and light pain from shoulder to elbow, now in its second day.

Sneezing bout of 10-15 minutes following injection. Fine until after dinner when I felt a liqiud draining in my right nostril. I suspected it to be mucous but was surprised when I wiped and blew my nose, red blood was on the tissue. It stopped bleeding and no longer bled. No other symptoms occurred. The injection site was tender but no erythema. I have not had an episode of epistaxis in over a year. Will be given 2nd dose on Teusday 3/16,21.

its bluish in color and it looks like there is bleeding under the skin; noticed his reaction/an area on the inside of his right thigh that looks like a hematoma; he has like a hematoma almost like a discoloration of the skin on the inside of his thigh/purplish color, like a bluish reddish but it is not red.; rash on the inside of his thigh. He clarifies well it is not a rash it is more like a hematoma; This is a spontaneous report from a contactable consumer (patient himself). An 83-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EN6198), via an unspecified route of administration on the left arm, first dose at age 83 years, on 25Feb2021 at single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. Patient stated that he got the Pfizer COVID 19 Vaccine yesterday (25Feb2021) at noon and this morning (26Feb2021), he has a rash on the inside of his thigh. He clarifies well it is not a rash it is more like a hematoma, almost like discoloration of the skin, it doesn't hurt but he wants to see if this is something that normally occurs. He showered last night and didn't notice it until this morning. He only noticed it about a half hour ago so he is not sure if there is any difference. He clarifies the area on the inside of his thigh is a purplish color, like a bluish reddish but it is not red. It looks like a hematoma, like bleeding under the skin. There is no swelling, it is not raised and it doesn't hurt to touch, just there. He didn't call his primary about this. He got this information so his doctor does not know anything about it. If it is something to be concerned about he will run down to the emergency room but he will see if he can find the office contact info. Outcome of the events was not recovered. Case was reported as non-serious.

Didn't realize what was going on; Whole body felt like itching, whole body was just feeling funny; Feet are numb and cold; Feet are numb and cold; Ended up in the emergency room because I was having some problems with chest pain; heart problems; Sick all day Saturday, all day Sunday, and most of Monday; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male (also age at vaccination) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right (reported as Right upper arm) on 27Feb2021 (Batch/Lot Number: EN6205) as SINGLE DOSE for covid-19 immunization. Medical history reported that "I have had one stent and one angioplasty done. Stent was done last year in 2020 and angioplasty was done in '1990' (not confirmed)." The patient also added "I gained a bunch of weight when I had my thyroid removed." The patient previously took the first dose of bnt162b2 on unspecified date for Covid-19 immunization. For the concomitant medication the patient stated, "Yes, I am taking medications." (specified medications not reported/ provided). It was reported by the patient that, "I got this, my second COVID-19 Vaccine shot Saturday morning. All day Saturday (27Feb2021), all day Sunday and most of Monday, I was so sick, I didn't realize what was going on. Yesterday (02Mar2021), I ended up in the emergency room because I was having some problems with chest pain. So, I presume this is all connected to the second shot I got." It was added by the patient, "I am asking question. About an hour or less than an hour ago I woke up, and my whole body felt like it was itching. I mean my whole body was just feeling funny. I was itching all over, that went away, I took a pill a while ago for that. 'Lorazepam' (not confirmed over the call), it's a nerve, anxiety pill and it kind of helped. But right now, my feet are numb and cold." For the laboratory test the patient stated that, "Yes they did a lab test on me yesterday (02Mar2021) as I went to the emergency room with some heart problems. They did blood work, that's all they did." The patient reported for the results, "They said everything was fine." The outcome of the events was unknown. The patient explained that "No, I didn't take any medication for that." However treatment was received for Whole body felt like itching, whole body was just feeling funny.

redness, swelling, soreness, pruritic symptoms subsided, for treatment patient applied cold compress to injection site and active ROM was initiated to left arm.

Very sore injection area; Temperature of 100.4 degree; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration date: not available), via an unspecified route of administration in the left arm on 09Feb2021 at 11:15 (at the age of 83-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation. The patient had no known allergies. Prior and post to the vaccination, the patient was not diagnosed with COVID-19. No covid tested post vaccination. The patient had no other vaccine in four weeks. The patient received other medication in two weeks. On 09Feb2021 at 15:00, the patient experienced very sore injection area for two days. Temperature of 100.4 degree and down to 99 degree after 36 hours. The patient did not receive any treatments for the events. The clinical outcome of the very sore injection area was recovered and Temperature of 100.4 degree was recovering. Information on lot/batch has been requested.

Itchy hands, legs, head, top of head and his face is itchy; achy and hurts where got the vaccine; he also has itching also on arm where vaccine given; scratching eyes; This is a spontaneous report from a contactable Consumer. An 83-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9Z6Z) via an unspecified route of administration in the left arm on 26Jan2021 (at the age of 83-year-old) as a single dose for COVID-19 immunisation. The patient medical history included parkinson's (ongoing) diagnosed 3-4 years ago, 2 stents placed in heart on an unknown date in2009, high cholesterol and high blood pressure diagnosed about 20 years ago (ongoing), right total knee replacement on 08Dec2020, prostate enlargement surgery on an unknown date in 2019 (2 years ago). The family medical history was none. The patient did not receive any other vaccine within 4 weeks prior to the vaccine and did not had history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive any additional vaccines on same date of the Pfizer vaccination. The concomitant medication included 15 to 20 different tablets a day (not specified). It was reported that patient experienced itching on an unknown date in 2021. The reporter thought that itching was caused due to detergent and washed everything without detergent thinking maybe he was allergic. The patient had itchy hands, legs, head, top of head and his face was itchy on an unknown date in 2021. It was reported that patient was scratching his eyes, hands and head using nails like an animal. Patient added that he also has itching also on arm where vaccine given, still achy and hurts where got the vaccine on an unknown date in 2021. The patient visited a primary doctor since he was due for a visit (right knee replaced 2 months ago). The patient complained about itching to doctor and doctor said it might be due to dryness. The patient had made appointment for 2nd vaccine. The patient states he has done nothing special or specific besides washing hands every time. The patient did not receive any treatment for the events. The outcome of the events Itchy hands, legs, head, top of head and his face is itchy, achy and hurts where got the vaccine and scratching eyes was not recovered while for other event was unknown.

Swollen glands in face and neck for entire time since shot. whole body rash and itchiness that has become worse over time

Improper vaccine reconstitution with 1ml saline and 0.5cc given. RN was in the home for at lease 45 post vaccine for in home assessment. Client was called in the afternoon and notified of the improper dosage. Was not having any effect post injection. Client was called the following day 4/3/21, client reported a sore arm at the site. Client was called 4/5/21 and the sore injection site resolved. No other immune response reported.

rash or hives on whole body. Red blotchy marks. felt like pins jabbing; rash or hives on whole body. red blotchy marks. felt like pins jabbing.; rash or hives on whole body. red blotchy marks. felt like pins jabbing.; This is a spontaneous report from a contactable consumer (patient, self-reported). An 83-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN9581 and expiry date was provided), via an unspecified route of administration, in the left arm, on 22Feb2021 at 08:30 AM (at the age of 83-years-old) as a single dose for covid-19 immunisation, at hospital. The patient had no known allergies. Medical history included cancer and finished chemo on 13Jan2021 (start date was unspecified date). The patient's concomitant medications were not reported. 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 22Feb2021 at 13:00 on same day (as reported), the patient experienced rash or hives on whole body, red blotchy marks and felt like pins jabbing. The patient was treated with Cetirizine (ZYRTEC) 1/day, diphenhydramine (BENADRYL) 25mg at bedtime and acetaminophen (TYLENOL). The clinical outcome of the events was recovering.

Had very little pain at the injection site; severe pain in my left shoulder; could not raise my left arm to the side without severe pain; This is a spontaneous report from a contactable consumer patient(himself). A 83-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: EL9265, Expiration date: unknown), via an unspecified route of administration on left arm on 27Jan2021 04:30 PM as single dose for COVID-19 immunization. Patient medical history included diabetic, high blood pressure, overweight from unspecified date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient didn't have allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not tested for COVID-19 since the post vaccination. The Patient concomitant medication were not reported. Patient took unspecified other medications in two weeks. The patient experienced very little pain at the injection site on 1Feb2021 at 7:00 AM. After about 3 days he awoke with severe pain in his left shoulder and patient could not raise left arm to the side without severe pain in Feb2021. It seemed to be concentrated in the rotor cuff muscle. Patient not received treatment for the adverse events. The outcome of event was recovering.

injection site pain both after First and second jab; This is a spontaneous report from a contactable consumer (patient). A 83-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration, administered in left arm on 02Feb2021 at 02:30 (at the age of 83years old) as a single dose for COVID-19 immunisation. Medical history included old age, BP, mild prediabetic, arthritis of knee. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took historical vaccine on first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown) in left arm on unknown date for covid-19 immunisation. On 04Feb2021 at 12:00 the patient reported that he did not get any adverse reaction except injection site pain both after first and second jab. Will I get antibodies after this shot considering my age is 83. It was unknown if the patient received any treatment for the events. The outcome of the event was unknown. Information on the lot/batch number has been requested.

had a rash that had broken out especially on his scalp, shoulder, back and it itched; had a rash that had broken out especially on his scalp, shoulder, back and it itched; This is a spontaneous report received from a contactable consumer (patient). An 83-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (lot number: ER2613, NDC number: 59267100002) at 10:30 at single dose for COVID-19 immunization. The relevant medical history included thyroid gland not working. Concomitant medications included ongoing levothyroxine for thyroid gland not working. The patient previously received first dose of BNT162B2 on 18Mar2021 at the age of 83 years old for COVID-19 immunization. The patient had a rash that had broken out especially on his scalp, shoulder, back and it itched on 11Apr2021. The patient received treatment included Eucerin cream, used for relief, just put it on, it's a cream, it had ingredient like "Piroctone Olamine" (not clarified) for protection. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.

Swelling face; Chills; Face is deep red; following day my face started getting red; Swelling is going down a little bit now, but it itches; Swelling is going down a little bit now, but it itches; I have been sleeping for 2 days; This is a spontaneous report received from a contactable consumer (patient). An 84-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot Number: EL3247) via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunization. The patient medical history included Blood pressure. Concomitant medication included VITAMINS NOS. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EJ1686; Expiration Date: unknown) on 21Jan2021 for COVID-19 immunization. The patient experienced swelling face, chills, face is deep red; following day my face started getting red swelling is going down a little bit now, but it itches, I have been sleeping for 2 days. The patient underwent lab tests and procedures which included blood test and results was unknown on 21Jan2021. The outcome of events swelling face, chills, face is deep red; following day my face started getting red, swelling is going down a little bit now, but itches was unknown. The swelling is going down a little bit now was recovering. The outcome of event I have been sleeping for 2 days was recovered on an unspecified date.

shingles; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL0140), via an unspecified route of administration, administered in Arm Left on 13Jan2021 (received at the age of 83-years-old) at 0.3 mL, single for COVID-19 immunisation. Medical history included pacemaker and atrial fibrillation. There were no concomitant medications. The patient had his first Pfizer vaccine shot on 13Jan2021 and was scheduled for the second on Wednesday, 03Feb2021. Six or seven days after getting the first dose, in Jan2021, he noticed little red spots. He came down with shingles and his doctor has prescribed him valcyclovir. It's an antiviral medication and he just want to be sure he'll still be able to get the second dose of the vaccine. His physician gave him a miracle medicine for it, Valacyclovir, an antiviral medication, he gathers, and it has done a great job. He has taken it for 3-4 days; the shingles are now leaving. However, he has his next shot, his second shot of the vaccine is this coming Wednesday, and he wondered if anyone at Pfizer can say whether this antiviral for shingles, a pill, is in any way perhaps going to interfere with the COVID second shot. He further stated, "I tell you, that first shot went in like a hot knife through butter!" Outcome of the event was recovering.

Presented to ED ~ 12 hours after receiving 2nd Covid vaccine. Chief Complaint: FEVER. (Pt had second COVID vaccine around noon. He presents via ambulance " feeling terrible" with fever, malaise. He is somewhat confused and uncomfortable here. Daughter in law here). No muscle aches, chest pain or cough. He has had loss of appetite. He has had dyspnea (chronic). He has had altered mental status (mild confusion). He has had skin rash (chronic LE). Pt was kept for observation x3. He was given IV fluids and a started 4.5 gm of Zosyn (Piperacillin Sod-Tazobactam So). Diagnosed with pneumonia - switched to oral augmentin at discharge. On home oxygen.

4 days after receiving the vaccine the patients arm swelled up and was painful. Arm is bruised from deltoid to above the elbow . Purple and yellow bruises are still visible 3 weeks later. Patient did see physician and physician advised patient to receive the second dose

Beginning 5/14/2021 shortly after rising, and continuing on most but not all days but still continuing to date, a red rash and/or red bumps (hives) over small areas of arms and/or thighs and they were mildly itchy. Treated with cortisone-10 cream and condition gone within 30-60 minutes for rest of the day. Also additionally tried Benadryl one day but stopped when label showed possible impact on prostate. Saw Dr. on 5/25/2021, a dermatologist, who confirmed hives and predicted condition should likely disappear in 6 weeks.

Blister under true breast leaking fluid hurting; Blister under true breast leaking fluid hurting; Started itching and might have scratched it; This is a spontaneous report from a contactable consumer. A 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3249), via an unspecified route of administration, on 24Jan2021 at 09:30 (at the age of 83-year-old) as 1st dose, single dose in left arm for COVID-19 immunisation at Hospital. The patient's medical history was not reported. Concomitant medications included lovastatin 10mg, and Amigo stone hcl 200mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021, the patient experienced blister under true breast leaking fluid hurting. Patient noticed blister on lower right abdomen, did not bother and went to bed, and later it popped out. Patient started itching and might have scratched it. Patient never had this before, until after the COVID-19 shot. It was a three-quarter inch line. When the blister popped it leaked over on the skin and another blister appeared, and stated there were about 5 blisters. It was real sore. Patient used Calamine lotion on it and it was great after that. Calamine lotion dried it fast, stopped itching and got good relief. Patient enquired what else he needs to do. The clinical outcome of the events was recovering. Follow-up (29Jan2021): This follow-up is being submitted to notify that new event ‘Started itching and might have scratched it' added, updated onset date of all events.

A small, itchy rash started in a few days. It spread across my arms and legs an chest and back in the first couple of weeks. One dermatologist suggested it was eczema and gave me a cream. After a couple more weeks the rash was evolving from 1/8 " itchy spots to 1/2 " scaly itchy spots. A second dermatologist prescribed a steroid. It's worse now and nothing has helped!

The patient states a couple days after his second Covid Pfizer vaccination he started to experience pain inside his arm. He has a bruise next to where the vaccination was given. He has limited range of motion in the left arm.

Pain @ injection site; muscle pain, shortness of breath, fast heart beat, difficulty breathing, vomiting at 4:45 am and at 5:40 am on 1/16/21.

Resident had a rash all over his body about 12 hours after 2nd dose of Pfizer vaccine. He started becoming SOB even with oxygen applied. On-call provider was notified and resident was treated with benadryl 25mg by mouth once. Symptoms resolved about 2 hours post benadryl dose.

Reaction occurred a few hours following the 2nd dose. Initially itching of hands, especially between fingers. No rash noted. The following day he developed intense itching and rash on his back, which spread to his chest, arms, and legs. Reports stinging, or a feeling like when you have splinter when the rash is touched. No reaction following first dose.

pins and needles in the feet, toes, bottom of the feet; it's just uncomfortable and the bottom of my feet; My wife says it can be Psoriasis; This is a spontaneous report from a contactable consumer (patient). A 84-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After vaccination, the patient park the car and all of a sudden he started to get like pins and needles they used to call in old days in his feet, in his toes. Last time he had this something like this years ago, he sat in the car too long. So, he loosen up his snickers and all and sat there, everything else was all right, a lady came over 15 minutes later and she said okay they can go. So the patient said he got some pins and needles in his feet, before he said the lady said "huh, are you having trouble breathing or anything", the patient said no he felt fine. So let they go home, and then the patient went home it's at night when he was laying down he didn't get much reaction and all. So he went up to the doctor she looked at up a few things and opened few things and the patient didn't think the doctor really had an answer for it. It was scheduled to go Monday again for the second it was still there. The patient didn't know it was probably kind of nerve reaction and all and his wife said it could be psoriasis, he never had this, it was not aggravating it's only when he walked he forgot he even had it . It's just uncomfortable and the bottom of his feet. He never had any reaction to any shot whether it was shingles or pneumonia, flu shots or whatever. The outcome of events was unknown. Information on the batch number/lot number has been requested

patient arm hurt/very sore; swollen very hard; arm hurt and it was warm; very painful for him to touch where the injection went in; not comfortable; This is a spontaneous report from a contactable consumer (patient wife). An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Jan2021, patient arm hurt, started to feel pain on 22Jan2021 and in the morning his arm was very swollen and very sore. He got up in the middle of the night and he said that his arm was swollen, and it was warm and swollen very hard, and 5 days later, the arm was still hard and warm and it was still very painful for him to touch where the injection went in. Caller was very concerned that this point that 5 days later could the shot gone in and then not gone anywhere just be sitting in that muscle. Patient can't touch it because it hurt too much. It was reported patient was not comfortable. Outcome of events was unknown.

Hives and Rash on body more on front stomach and both thigh areas saw my pCP dr Agarwal , continue Benadryl 25 mg three times a day then start prednisone10mg as prescribed from tomorrow if rash does not get better second dose was on Feb 2nd and reaction on 15 th FEb

sore at inj. site; breaking out on legs and top of feet; This is a spontaneous report from a contactable consumer (patient himself). An 84-year-old male patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not available), via an unspecified route of administration on the left arm, on 28Jan2021 at 14:15 at single dose for COVID-19 immunisation. Medical history included diabetes and allergies, both from an unknown date. Concomitant medications included unspecified "regular meds." On 29Jan2021 at 19:00, it was reported that the patient experienced sore at inj. site and breaking out on legs and top of feet. No treatment was received. The events were considered as non-serious by the reporter. The events did not lead to death, life-threatening condition, hospitalization, disabling/incapacitating, or congenital anomaly. The patent has not been diagnosed with COVID 19 prior to vaccination and has not been tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior. The outcome of the events was unknown. The patient was vaccinated at a hospital. Information on the lot/batch number has been requested.

After the second vaccination in the right arm on 2/4/2021, the site of the first vaccination in the left arm on 1/14/2021, bagan to hurt, and has continued to hurt.

a little bit of soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). An 84-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on left arm on 18Jan2021 at single dose for COVID-19 immunization and apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date and ongoing at an unspecified dose and frequency for an unspecified indication. Medical history included Afib years ago, heart rate abnormal (reported as heart rate); and sleeping with oxygen but has not had any trouble breathing which was ongoing. Concomitant medications included propranolol hydrochloride (MANOPROLOL; also reported as MONOPROLOL) for Afib and unspecified medication to control heart rate. The patient reported that he got the first dose of COVID vaccine with no problems but had a little bit of soreness at the injection site the next day (19Jan2021). The patient was taking apixaban and mentioned that he did don't know if that was important or not. The action taken in response to the event for apixaban and the outcome of the event was unknown.

Caller is a 54 y/o M reporting that he, his 53 y/o F wife and 84 y/o F all received the Pfizer COVID-19 vaccination and have developed symptoms after vaccination. None have ever had adverse reactions to vaccinations. A 400. Advised can have injection site pain, fatigue, headache, muscle aches, chills, joint pain, and fever. Swollen lymph nodes and nausea have also been reported. Advised to seek medical attention if experiencing any shortness of breath, throat swelling, weakness, or diffuse body rash. Cough, shortness of breath, runny nose, sore throat, or loss of taste or smell are symptoms of SARS-CoV-2 or another infection and not consistent with post-vaccination symptoms. Advised PC is available as needed. TR

slight redness to injection site; slight pain; COVID-19 vaccination; This is a spontaneous report from a contactable consume (patients). This consumer reported similar events for 2 patients (Himself and wife) this report is for 1st of 2 patient. A 84-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E18982, Expiration date: UNKNOWN) in left arm on 06Feb2021 at 08:40 as a single dose for covid-19 immunization. The patient medical history and concomitant medication was not reported. The patient experienced slight redness to injection site, slight pain and covid-19 vaccination on 06Feb2021. The reported said that their vaccine cards are handwritten and they got the same LOT, he provides unknown number PF1202, which he thinks means Pfizer with an ID number they may have given him and he says NDC/EXP were not provided on their handwritten vaccine cards. The patient was not given treatment for AE slight pain and it went away, also the slight redness went away, there was a little bump. The reporter said it was not bad, it was good that their side effects were small and not massive at all, and it was a little thing but they are concerned if their reaction could be considered unusual, like some people, or if should it could be a stronger dosage. He says at the time their vaccines were done in cars, so he has no knowledge of temperature or amount of dosage, and says that after they get their second dose on the 17th. The outcome of the event slight redness to injection site was recovered on Mar2021 and other outcome of the events was unknown. No follow up attempts are possible. No further information is expected.

He believes the trouble started in the wake of his CoViD-19 immunizations (Moderna #1was given on 2/12/2021 and #2 was given on 3/12). Both shots were given into the left arm. He reports some soreness at the injection site on the left arm after both shots, but this soreness has persisted with some stiffness and difficulty abducting the arm beyond 90 degrees. Two weeks after the first shot, his right shoulder started hurting also, worst distal to the glenohumeral fossa without radiation, also aggravated with abduction beyond 90 degrees. Some soft tissue swelling was noted around the hand. Simvastatin was discontinued with no improvement in symptoms. Labs showed a sed rate of 54 mm/hr and C-reactive protein of 46 mg/L. Blood cultures were drawn which were negative, suggesting no evidence of osteomyelitis flare. He was started on prednisone 15 mg PO daily on 4/5/2021 with rapid and dramatic improvement in symptoms. Presumptive diagnosis is polymyalgia rheumatica, but he had no previous history of same, and onset of symptoms was remarkably close to the immunizations.

went on Saturday afternoon to the Arena where the 2nd dose was given. On Sunday afternoon he was not feeling well, achy, and by evening slightly light headed. Monday morning he had worsened, and tried to stand, and collapses, the home health nurse called for an ambulance. By mid afternoon on Monday March 1st he was blue around the lips and skin, doctor worked to try and stabilize him throughout the evening, until his heart stopped at 1:30am on March 2nd.

Pain in my right arm; It shoots up into my shoulder sometimes; This is a spontaneous report received from a contactable consumer (patient) via Medical information team. A 84-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in right arm on 17Feb2021 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 17Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated that, about 1-2 weeks after receiving the 2nd dose I started having pain in my right arm, where I got my shot and it shoots up into my shoulder sometimes. This morning the patient stated he used my heating pad for the pain. Patient asked what should I do about this pain. Is it normal to have it weeks after the vaccine dose. It was reported that Pfizer person I was speaking to before you told me you would be able to tell me what to do about the pain and treatments. I have been on the telephone for over 90 min and don't really know any more than when I started calling. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

rash on his legs; This is a spontaneous report from a contactable consumer. This consumer reported that her 84-year-old husband received the first dose of BNT162B2 at single dose on 20Apr021 at 09:45AM in the right arm for COVID-19 immunisation. Relevant history included Hemophilia; Patient was born with this. He receives Factor treatment every 10 days, wound on his bottom since Feb2021, hospitalized and being treated with a wound vac, the patient was bedridden. Relevant concomitant drug included eftrenonacog alfa (ALPROLIX) for haemophilia, melatonin for Sleep apnoea syndrome, donepezil for Amnesia, ascorbic acid (VITAMIN C ACID), vitamins nos (FLINTSTONES), colestyramine (CHOLESTYRAMINE) for blood cholesterol abnormal, memantine, celecoxib for arthritis, doxazosin for blood pressure abnormal, alprazolam for relax, amlodipine for blood pressure abnormal, losartan for blood pressure abnormal, bioflavonoids nos, lecithin, quercetin, ubidecarenone (CO-Q-10 PLUS), colecalciferol (VITAMIN D3) and chondroitin sulfate, glucosamine hydrochloride (CHONDROITIN GLUCOSAMIN). The patient's wife happened to notice a rash on patient legs on 20Apr2021 about 11:30AM. Her husband was bedridden and she just took the cover off about an hour ago and that was when she spotted the rash. The physical therapist was working with her husband right now and the therapist told her the rash had not worsened and may be a little better. It looked a little lighter. Her husband was in the hospital in Feb2021, predating treatment with the vaccine, and he has a wound on his bottom from that hospitalization and was being treated with a wound vac. There is no need a visit to Emergency Room or Physician Office for the event. The outcome of event rash was resolving. Patient was planning to receive the second dose on 11May2021. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccination (within 4 weeks) was none. Relevant test was none. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Shingles; he got real sick; This is a spontaneous report from a contactable consumer (patient's wife). An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20Feb2021 (Batch/Lot Number: EN6198; Expiration Date: 30Jun2021) as 1st dose, single for covid-19 immunization. Medical history blood pressure and high cholesterol. Concomitant medications included valsartan for blood pressure and simvastatin for high cholesterol The patient got his vaccine on 20Feb2021 and two days later he got real sick and broke out with shingles. The reporter stated that they are still improving. The patient was treated with valacyclovir 1000mg. The patient did not go to hospital. He did not get the second shot that is why the reporter was calling for. She doesn't know if the patient should get the second shot. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Round itchy red patch; This is a spontaneous report from a contactable consumer. A 84-year-old male Patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry date was Unknown) via unspecified route of administration on27Jan2021, 03:00 PM (at the age of 84-year-old) as a single dose for COVID-19 immunization. The patient past medical history included diabetes mellitus. The concomitant medication was not reported. There was no known allergies. Patient did not have COVID-19 prior and post to the medication. On 04Feb2021, the patient experienced Round itchy red patch. The outcome for the event recovered on an unspecified date in 2021. Information on the Lot/batch number has been requested.

pain in his left wrist; arm pain and swelling to left arm; arm pain and swelling to left arm; swollen under side of his arm where he got the vaccine injected; pain in his left wrist, which was the same arm that he received his injection; This is a spontaneous report from a contactable consumer, the patient. A 84-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 13Feb2021 (at the age of 84-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9262), via an unspecified route of administration, administered in left arm on 23Jan2021 (at the age of 84-years-old) as a single dose for covid-19 immunization. Medical history included hypertension, occasionally rapid heart beat, blood cholesterol abnormal, cardiac operation (9 years ago, macular degeneration (in each eye and puts eyedrops in and occasionally they give him injections). Concomitant medication(s) included atorvastatin (LIPITOR [ATORVASTATIN]; 10mg everyday) taken for blood cholesterol abnormal; estradiol (ESTROGEN; 10mg everyday). The patient did not have any other recent vaccinations or started any new medications. The patient reported practically had no symptoms with either shot. After his first dose he had one day where his blood pressure went very low but by the time he talked to his cardiologist it had gone back to normal and was taking pills, it was under control. Yesterday afternoon he experienced pain in his left wrist, which was the same arm that he received his injection, and describes the pain as not too bad. He states that when he uses his wrist in certain positions, the pain "shoots up." This morning on the lower part of his left arm ("not the top where I got the injection") he has "slight pain." He says this morning his upper arm on the underside where he got it on the left side is swollen. He says he would like to know can it be from vaccine, though maybe he could have strained his wrist, it happened yesterday evening, he had wrist pain and swollen under side of his arm where he got the vaccine injected. He says yesterday late afternoon was the first time, it could be something else, it was the same arm this morning he has a little pain to his upper arm that was not on injection side but below, under it. The patient did not received any treatment, it was not serious pain, it was low level pain, when he uses his wrist and turns it, it comes in more prominent. He says it was not pain that bothers him, if it was not related to the vaccine then he most likely strained his arm. No follow-up attempts are possible. No further information is expected.

Pt R hand and foot started swelling 4/20/2021, 2 days after Pfizer shot, on 4/18. Pt admitted to Hospital 4/23-4/25/2021. Pt was diagnosed with cellulitis and treated with IV antibiotics. Pt also treated for exacerbation of CHF and COPD. Pt re-hospitalized 5/7-5/12/21 for COPD and CHF exacerbation, a-fib with RVR, acute respiratory failure with hypoxia, and gout of R wrist Pt went to STR from 5/12-5/18/2021

Patient got his vaccine on 5/29/21 and then received his normal chemotherapy treatment a few days after receiving the vaccine. He had red blotches all over his body and his left leg swelled. He didn't have any problems with his first vaccine. He was and is currently taking a prednisone taper. He's still experiencing these blotches and it doesn't seem to be getting better so he wanted to make sure the pharmacy was aware.

Blotches on arms and legs; Itchy; This is a spontaneous report from a contactable consumer, the patient. An 84-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: En6208) via an unspecified route of administration in left arm on 16Mar2021 at 11:15 (at the age of 84-year-old), as a single dose for COVID-19 immunisation. It was reported that the patient was allergic to past drug codeine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration on unknown date, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications received within two weeks of vaccination included simvastatin (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN) for unknown indication. On 16Mar2021, at 13:15, the patient had various size blotches on his arm and legs (skin blotches) which extremely bothersome and itchy. Therapeutic measures were taken for the events skin botches and itchy included treatment with a cream (unspecified cream). 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 skin blotches and itchy was resolving at the time of this report. No follow up attempts are needed. No further information is expected.

He developed an itchy rash after the 2nd dose; Still have the rash and itching; Still have the rash and itching/ waking up scratching all the time; Still have the rash and itching/ waking up scratching all the time; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 84-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5318 and expiration date was not reported), second dose via an unspecified route of administration on 03Feb2021 (at the age of 84 years) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported), first dose via an unspecified route of administration on 14Jan2021 as single for covid-19 immunisation. On unspecified date of 2021 after the 2nd dose patient developed an itchy rash. Patient had been seen by his HCP and they gave given him 2 doses of Prednisone, hydroxide for itching, as well as Zyrtec. Patient states that "none of it helps. Still have the rash and itching. Not as bad but still there and waking up scratching all the time." Patient is "wondering if there is someone at Pfizer that can indicate what he can be taking that may help the rash." patient states the problem is he is not sure the doctors know what to do with the vaccine being so new. patient states he is not sure going back and forth to the doctor is going to help and questions if the health department would possibly know more. The adverse events involved visit to physician office. The outcome of the event still have the rash and itching/ waking up scratching all the time was unknown, while the rest of the events were not recovered. No follow-up attempts are possible. No further information is expected.

itching; bottom lip was swollen; This is a spontaneous report from a contactable consumer via the Medical Information Team. An 85-year-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date at a single dose for an unspecified indication. Medical history included hard of hearing. The patient's concomitant medications were not reported. It was reported that the patient started itching and bottom lip was swollen. Bottom lip swelling has gone down today but she has still itching all over the body. She tried Benadryl but not helping. The outcome of the event itching was not recovered while recovering for the other event. Information about Lot/Batch has been requested.

Patient received Pfizer-BioNTech Covid-19 vaccine, first injection, in the afternoon of Tuesday, 1/19/2021 - administered by pharmacy staff. All residents and staff of the facility were vaccinated (except one resident). Wednesday afternoon (1/20/2021), patient was noted to have a open area on his 3rd left toe with digital edema and blackening of toe, 2nd toe had a fluid filled blister as did area superior to left medial knee. There was also an open area inferior to left medial knee. Bruising or blackened areas to 3rd left toe and bottom of left foot (pad below toes 1-3). Patient was placed on Keflex 500 mg BID for 10 days, Clotrimazole 1% topical cream for ring worm middle of left foot, and ammonium lactate 12% lotion for dry skin. By Saturday, 1/23/2021, multiple blisters had erupted on patient's left medial knee area and 4th left toe. Some of the prior blisters were now gone, but new blisters were larger. On Thursday, 1/28/2021, patient now has blisters and open areas on bilateral feet, legs, and hands. He has a red rash on his right lower leg just superior to the medial ankle. Patient was placed on a 10 mg Medrol Dose Pak. There have been no changes to the patient's diet or medications. Patient is confined to the facility due to dementia. He goes from his bedroom to a sitting area, right outside of his bedroom door. He ambulates with assistance using a cane, only to the bathroom in his room. He has a private room.

itchy rash in b/l arms. itch resolved after 3 hours, and skin became scaly and peeling in tiny patches about 0.5 cm, multiple, across b/l arms.

Following the second dose of Covid vaccine, an area of redness formed on the bicep of the same arm with severe itching. Itching has been mitigated by frequent use of topical one percent hydrocortisone ointment along with aloe vera gel.

Swelling of face. Denies difficulty swallowing, shortness of breath, rash. BP 136/68, RR of 16, HR of 84. Benadryl 25mg PO given at 1625 and was observed for an additional 15 minutes. No worsening of symptoms and slight improvement. He is here with his daughter who is an RN and feels comfortable taking him home. No further treatment initiated.

Feb 9, patient was light-headed, as if he was going to faint. He did not have appetite. Evening of Feb 9, started vomiting large amounts of blood. Ambulance took him to hospital. CT scans showed abnormally enlarged pancreas. Patient aspirated blood and was put on a ventilator for 48 hrs. Endoscopic ultrasound showed ulcers in stomach that appear to have been bleeding, which were clipped and shot with epinephrine. After being treated for ulcers, patient developed blood clots in leg and lungs. It is almost two weeks since initial emergency, and patient is still showing sings of internal bleeding (low blood pressure, low hemoglobin, blood in stool). Still no firm explanation for continued bleeding. Before adverse event on Feb 9, patient did not report other symptoms from shot, however, he did show unusual signs of large bruising on his arm. Patient is currently at Hospital. Blood thinners are being discontinued, but patient still has blood clots.

Localized redness and nodule s/p vaccine administration. Pt A/Ox4, Skins normal for ethnicity. Resp unlab and even. NAD. Denies any other s/sx at this time. Ice pack applied to site.

Patient received his second dose of COVID vaccine on Monday. The next day started to develop an itchy rash over his upper back. It started on his upper back near the shoulder he got the injection. It then spread over the remainder of his upper back and the remainder of his back. Patient given triamcinolone cream to help with rash.

Narrative: Patient received COVID/Pfizer #1 2/10/21 in L deltoid. (Patient home bound). On 2/12/21 reported left flank rash. 2/13 rash spread to entire abdomen/chest and UEs. Continued with fluctuations in BP/HR, fluid retention. On 2/16 labs ordered and Medrol dose pack. seen in home on 2/19 by MD - RUE swelling; diffuse rash over entire body; additional labs ordered (order to home infusion company). Patient passed in AM of 2/20/21. Reported no urine output the prior evening. Additional labs not performed due to death of patient prior to lab company arrival.

Patient stated he started having hives, diarrhea and chills 2 days after the vaccine. At the current time, 2 weeks later, he is still having the same adverse events and now has leg weakness.

Patient noticed skin being red, itchy a few days after injection. After scratching he noticed a raised red rash this morning. Symptoms come and go.

Developed rash on forearms (3/4/21) which gradually worsened in scope and severity. By am of 3/5/21 rash was covering abdomen, chest, arms and buttocks. By 3/6 the rash was present on thighs, knees, behind knees. On 3/7 rash was present on face, top of head, throat and back. Severe itching and burning accompanied rash. The rash started out as patches of red raised areas that within 24 hours of emergence morphed into diffuse red splotches (appearance of severe sunburn). Drs. Visit on 3/5 with injection of 120mg cortisone and direction to take benadryl up to 6 tabs/day. No other body symptoms other than rash and itching/burning. Call to Drs office 3/8 to report continuation of rash and he was instructed to take Zyrtec. As of 1:59 pm today 3/9, the rash has improved on stomach, legs, buttocks but remains present in varying degrees on other parts of body.

Rash over entire body but severe primarily on hands, legs and buttock. Several days before rash, extreme tiredness, As rash appeared two days of fever going as high as 102. Several doctors visits to diagnose rash. Biopsy done. Oral Prednisone and prescription strength cortisone cream.

Patient is a very pleasant 85-year-old male who presented to the emergency department first on 3/8/2021 via private vehicle accompanied by his spouse in no acute distress with complaints of left arm pain and swelling after receiving his Pfizer COVID vaccination on 3/2/2021. Medical history includes hypertension, heart failure, CAD, GERD, diaphragmatic hernia, chronic left shoulder pain, among others. Patient states he received his vaccine on Tuesday and began to develop pain, swelling, and bruising at the injection site on Thursday. Since that time all of his symptoms have worsened. 9/10 pain this morning has lowered to a 4/10 after 2 tylenol, which he took approximately one hour prior to arrival. Is not anticoagulated but takes baby aspirin daily. He did stop this when he first noticed the bruising. Denies recent trauma, including falls. His chronic left shoulder pain is unchanged from baseline; the pain he presents to the ED for is located lower at the injection site. Further notes pain patches helpful with his pain. Seen again on 3/15/2021 for persistence and involvement of his forearm with the bruising and pain.Over the last week the purple discoloration has migrated down his arm towards his hand. He denies any new numbness or weakness in the arm. Exam reveals impressive and extensive ecchymosis that involves both his upper and lower arm and is circumferential in nature. There is no area of discrete swelling or tenderness. Good peripheral pulses and capillary refill. Normal strength of hand. An ultrasound done showed no clot.

tiredness; chills; rash on his arm at the injection site; feels a little bit of warm when I touch it; rash on his arm at the injection site; feels a little bit of warm when I touch it; This is a spontaneous report from a contactable consumer (patient's wife). An 85-year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9263) via an unspecified route of administration in the left arm, on 11Feb2021 (at the age of 85 years-old) at single dose for COVID-19 immunization. Medical history includes emphysema and COPD (Chronic Obstructive Pulmonary Disorder) and Rheumatoid arthritis. The patient previously received the first dose of BNT162b2 ("it says Pfizer, can't make it out good but looks like Lot Number EL0142"; at the age of 85-years) on 21Jan2021 for COVID-19 immunization. Concomitant medications included methotrexate, weekly for rheumatoid arthritis and folic acid once daily for an unspecified indication. Concomitant medications include unspecified inhalers for emphysema and COPD. After receiving the vaccine, he experienced tiredness and chills (Feb2021). More than a week later he experienced a rash at the injection site which feels a little bit warm to the touch it (Feb2021). The rash is 2.5 inches wide, 3 inches long. His wife put a cold pack on it and it helped, the rash is not hurting or itching. The patient's wife stated it was odd that his rash appeared a week later right in the injection site in his left arm, she attributed it to the fact that he sleeps on this side. The outcome of the events fatigue, chills, injection site rash and injection site warmth was unknown.

Bruising on both arms from shoulder down to top of hand. Bruising only for first two weeks, then severe itching began on both arms and on back (which has no bruising).

for several hours my balance was much worse. By morning i was okay. Also, the next morning my right for arm was swollen and my skin had a reddish color. This has continued as of this moment

Pink to violaceous nonscaly papules coalescing into plaques on the thighs, inguinal folds, abdomen and posterior axillary regions-further characterized with histologic features consistent with granuloma annulare in an interstitial pattern (medication reaction can also induce this pattern). Rash has persisted--treatment is continuing.

Starting on 3/15/21 developed painful rash with raised bullae. Seen by dermatology on 4/6/2021 with biopsy confirming bullous pemphigoid. Was prescribed prednisone and when seen again on 4/15/21 rash was improved and resolving.

4/1/2021 routine lab work done for follow up Dr. visit, 4/2/2021 Dr.office called stated platelet count is 14,000 go to ER. Patient was admitted to the hospital and as of this entry still a pt. because the Drs can not get his platelet count up or to stay up ( range has been from approx. 7,000 to 30,000) Patient is in declining health. As I understand it labs from Jan /2021 the platelets were 77,000. He has been treated with IVIG, prednisone, NPlate, platelet infusions-please contact Drs. and the hospital Patient displayed NO outward bleeding of any kind. He had only1 small bruise about the size of a dime on the base/web of his left index finger

Itching; Aches and pains; Pins and needles; This is a spontaneous report from a contactable consumer (reporting for herself). A 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25Feb2021 12:00 (Batch/Lot Number: EN6202; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation (85-year age at Vaccination). The patient medical history was none. The patient had no previous allergies. Patient states he has a pacemaker and has a stent in his heart. Both have been there for over 10 years. The patient's concomitant medications include carvedilol (COREG) at 25 mg, twice a day taken for cardiac disorder (He has been taking this for years). It was reported that patient previously took first dose of bnt162b2 (Lot number: EM9809, Expiry date: 30Jun2021) 04Feb2021 11:00. It was reported that during that night he was getting aches and pains, he took Tylenol and was fine for a while week. The week after that, he started to get pins and needles all over his body, and itching. He states it did not want to go away. Sometimes it was better, sometimes it was worse. The doctor gave him antihistamines, but it did not go away. All the doctor's say they have never heard of it, no one knows what it was. He read some place that they have few cases like this. He was just trying to find out what he should do. He was itching all the time and got pins and needles. The antihistamine helps, but it comes back. It has been over a month now, almost 2 months. He asks what he should do. He had seen a cardiologist, urologist, and his regular doctor. In the beginning he had itchiness and pins and needles all the time, but now it was on and off. For example right now he did not have it but when he woke up this morning it was there. He tried different soaps and different shampoos, just in case that was it. He even took off some of the medications for a couple days to be sure it was one of them but no. He was almost 100% sure it was it, he never had this before. Started the night of the shot. It got a little better in the night. The next morning he took Tylenol and felt better and thought it was all over. It was then explained that it started again about a week or so later and now he has it all the time. Itchiness began a week or a week or a half. Then says it could have been 2 weeks later. The symptoms are on and off. For the aches and pains he took Tylenol and it went away. The doctor that prescribed Coreg said he never had anyone having trouble taking this medication with the vaccine. He never heard of that. That was the first thing he asked. Outcome of the event Aches and pains was recovered on 26Feb2021. Outcome of the other events was not recovered. No follow-up attempts are needed. No further information is expected

The patient was admitted to the hospital by the Vascular surgery service for right groin infection with wound dehiscence, and cellulitis. He will be treated with incision, drainage and antibiotics. He has a positive COVID-19 CR today as an incidental finding. The patient had COVID-19 in December 2020 ? positive test 12/22/20. He subsequently tested negative and returned to his nursing facility. The patient was vaccinated 1/26/21 and 2/16/21. The patient did not require any COVID-19 treatments. The patient had to stay in the hospital longer than needed because he could not be discharged back to nursing home.

Started feeling itching after 2 days, pimple like skin with red blotches all over body, near groin but not on. Has not went away, gets some relief when showers

Caller stated he may have gotten the "water " not good or not have gotten the full dose.; he may have gotten a bad dose; He said he got the second dose on the 29Jan "felt the heat like alcohol burning"/Second dose burned a little; he may have gotten a bad dose; This is a spontaneous report from a contactable consumer (patient). An 85-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3249), via an unspecified route of administration on 29Jan2021 as 2nd dose, single for COVID-19 immunization. The patient previously received first dose of BNT162B2 for COVID-19 immunisation and experienced sore arm, felt the fire chills and heat, arm pain for a couple days, felt the burning of it going in, little heat and a little chill but the next day he was on the way to being good. The patient medical history included really sick with the flu before getting the vaccine, it was just sick not really an event and was like he got the flu but in 2 hours. The concomitant medications were Advil and Tylenol. One Benadryl will knock him out. He said he gets sick with flu vaccine. On an unspecified date, the patient experienced felt the heat like alcohol burning when injecting but no sore arm nothing else, did feel the burn and it go into his arm but after an hour he left and has had no pain, none in his arm or hurting, nothing. His mind is going to go there and is thinking did he get a bad dose. He may have gotten the water not good or not have gotten the full dose. He wanted to know the proof that he has gotten the vaccine, are there any blood test or any test he could have to see if he got the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Diffuse red splotches that appeared like severe sunburn; Rash appeared as red, raised areas causing itching and burning; Rash appeared as red, raised areas causing itching and burning; Raised hive like areas; itching - mostly on face, neck and head which were the areas most recently to erupt; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200), via an unspecified route of administration, administered in right arm on 23Feb2021 (at the age of 85 years old), at second dose, single dose for COVID-19 immunisation. Medical history included atrial fib, CAD, DM type 2, implanted pacer/defib, gout, and known allergies to Sulfa. Concomitant medications included glipizide, amiodarone, apixaban (ELIQUIS), propranolol hydrochloride (INDERAL), levothyroxine, atorvastatin, furosemide (LASIX), and lisinopril. On 04Mar2021, rash developed in groin area and forearms 9 days after the second injection. Rash appeared as red, raised areas causing itching and burning. Rash continued to evolve migrating to abdomen, chest, legs, buttocks, back, face and head between 05Mar2021 and 09Mar2021. Raised hive like areas would morph into diffuse red splotches that appeared like severe sunburn, usually within 24-48 hrs. The patient consulted his physician on 05Mar2021, and cortisone 120 mg injection was administered with further direction to take diphenhydramine (BENADRYL).On 08Mar2021, cetirizine (ZYRTEC) was added to the regimen. As of report date, the patient was still experiencing itching - mostly on face, neck and head which were the areas most recently to erupt. The patient has no other symptoms other than those related to the rash. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, and treatment received included cortisone injection, BENADRYL, and ZYRTEC. The patient had no COVID prior vaccination and was not COVID tested post vaccination. The patient experienced only soreness in arm following first injection of BNT162B2 given for COVID-19 immunisation. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Hives throughout the body. Tried Benadryl which did not help. He is on Zyrtec 10mg daily . Allergist saw him and did not find any causes of allergies.

minor soreness at vaccination site; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (22Mar2021), this case now contains all required information to be considered valid. This is a follow-up spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL92U2) intramuscular, administered in Arm Left on 04Feb2021 23:30 (at the age of 85-years-old) as 1ST DOSE, SINGLE DOSE and second dose via intramuscular, administered in Arm Left on 23Feb2021 12:45 (at the age of 85-years-old) (Batch/Lot Number: EW6203) as 2ND DOSE, SINGLE DOSE both for covid-19 immunisation at Hospital. Medical history was none. The patient's concomitant medications were none. The patient experienced minor soreness at vaccination site on an unspecified date. It was reported that the two shots resulted in absolutely no reaction beyond a minor soreness at the vaccination site, which was gone within 24 his after each shot. patient was scheduled for a dental procedure 16Feb2021 that will require predosing with amoxicillin and a bone graft. Patient wants to know if either of these things will interact with his second dose of vaccine. He stated he had dental appointment for surgery, the strength of the Covid-19 Bone graft to repair the bone where the teeth come out- go back in an put implants into my lower jaw and attach crowns to it I have to take 3 days worth of amoxicillin TID, then day of surgery take a dose of 4 amoxicillin. Prior Vaccinations were reported as none. The outcome of the event was recovered on an unspecified date. Follow-up attempts completed. No further information expected. Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.

General feeling of not being well; Severe rash/Rash over most of body but most prevalent on hands, legs and buttock.; Superfical perivascular dermatitis; Fever; Tiredness; This is a spontaneous report from a contactable consumer, the patient. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UL9269) via an unspecified route of administration in the left arm on 12Feb2021 at 11:00 (at the age of 85-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included lisinopril [UNKNOWN MANUFACTURER], metoprolol [UNKNOWN MANUFACTURER], amlodipine besylate [UNKNOWN MANUFACTURER]. Patient previously took Sulfur and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced severe rash, superficial perivascular dermatitis, fever, feeling unwell on 25Feb2021. The lab test and procedures included biopsy with result superficial perivascular dermatitis and body temperature with result fever. Therapeutic measures were taken as a result of events and resulted in visit to health care professional's clinic and included treatment with oral prednisone, cortisone cream. The clinical outcome of the severe rash, superficial perivascular dermatitis, fever, feeling unwell was resolving. No follow up attempts are possible. No further information is expected

Client's significant other called to say that client had a full body rash. Rash was red but not angry and not itching. Client was able to breathe with no difficulty. There were no other issues with client's body (e.g., bruising, hot areas, raised areas) and client was hesitant to go anywhere to have rash tended to.

Chills; Fever / temperature; Elevated blood pressure; a little bit of redness or pain; a little bit of redness or pain; This is a spontaneous report from a contactable consumer (the patient). A 85-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0151; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in right arm on 15Apr2021 (at the age of 85-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included blood pressure. Concomitant medication included metoprolol taken for blood pressure, start and stop date were not reported (been taking it close to a year every morning). Additional Information for Concomitant Products metoprolol: He thinks it 100mg Extended Release. He was taking 250mg a day then they went to extended release. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8733; Expiration Date: 31Jul2021) intramuscularly in right arm on 25Mar2021 as a single dose for COVID-19 immunization. Prior vaccinations (within 4 weeks) not provided. On 29Apr2021 11:00, the patient experienced chills, fever / temperature, elevated blood pressure. On an unspecified date in Apr2021, the patient experienced a little bit of redness or pain. It was reported that "Caller stated that he had both Pfizer COVID vaccine shots, second one was two weeks ago today. Caller stated that he sailed along without a single symptom, maybe a little bit of redness or pain. Caller would like to know if there is a likely effect within or after 2 weeks of getting the Pfizer COVID vaccine. Caller stated that he has been isolating for almost a year, that he waited until things have eased up to get the Pfizer COVID vaccine and here he is seeing possible symptoms. Caller asks how long after the second Pfizer COVID vaccine do you hear of any adverse reactions. Caller states that his wife passed away about 2 months ago and the provider's office was very hard to get access to during that time. He experienced Chill, fever, and a temperature. His symptoms occurred a couple hours after he got up today at about 11AM. It happened all the sudden. Caller states that he has an infrared thermometer and has been taking his temperature and blood pressure on a regular basis along with an oxygen reading. Caller stated that his temperature was up over 102F and is down to about a 100F now. Caller stated that the temperature may still read high but he does not feel bad and is not having chills. Caller states that 97.6 is his usual temperature so it is up more than caller is accustomed to. Caller states that his blood pressure is normally 110/72 or 73 and that he is on metoprolol and has been taking it close to a year every morning. Caller stated that his blood pressure is back to normal. Caller states that he received both Pfizer COVID vaccines in his right arm because he is left handed and had no issue whatsoever in terms of use or limitations. Caller stated that the symptoms today are the first sign that the shot may have something to do with it. Caller stated that he hasn't done anything unusual in the last 2 weeks other than to get the Pfizer COVID vaccine. He asks if he needs to get any medical tests or if this is normal." On 29Apr2021, the patient underwent lab tests and procedures which included body temperature: 100F (over 102F and is down to about a 100F now), blood pressure measurement: normal and on unspecified date, body temperature: 97.6 (his usual temperature), blood pressure measurement: 110/72 (normally (110/72 or 73). Therapeutic measures were taken as a result of elevated blood pressure. The outcome of events chills, elevated blood pressure was recovered on 29Apr2021. Outcome of fever / temperature was recovering. The outcome event a little bit of redness or pain was unknown. No follow-up attempts are needed. No further information is expected.

Hives, after first vaccine; This is a spontaneous report received from a contactable consumer (patient). An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6202), via an unspecified route of administration, administered in left arm (left shoulder), on 12Mar2021 12:00 (at the age of 85-year-old), DOSE 1, single for COVID-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID 19 and since the vaccination, the patient had not been tested for COVID 19. The patient had no illness at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 30Mar2021 20:00, the patient experienced hives, after first vaccine. They (patient and his wife) had Chinese takeout food and he developed hives. When he broke out in hives, he talked to his doctor about getting the second vaccine, and his doctor told him to delay, the second dose, until the hives cleared up. Patient stated the hives cleared up overnight. The patient did go to the doctor for his hives. The relevant tests were none. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8734), via an unspecified route of administration, administered in left arm (left shoulder), on 16Apr2021 12:00 PM, as DOSE 2, single for COVID-19 immunization, at 35 days, after the first vaccine. The outcome of the event was resolved, on 31Mar2021. Follow up needed, further information has been requested.

onset of herpes zoster; This is a spontaneous report from a contactable physician. A 86-years-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 04Jan2021 10:00 single dose for COVID-19 immunisation. Vaccine location was left arm. No other vaccine was received in four weeks. Medical history included hypertension, connective tissue disorder. The patient experienced onset of herpes zoster on 12Jan2021. Therapeutic measures included oral antiviral (Valtrex), topical acyclovir cream, oral analgesics. The outcome was recovering Information about lot/batch number has been requested.

pain in right groin; difficulty walking; arm soreness; redness on the toe of his left foot; This is a spontaneous report from a contactable consumer (patient himself). An 86-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL1284, expiration date was unknown), via an unspecified route of administration on the left arm on 16Jan2021 at a single dose for COVID-19 immunization; it was offered to him and he was in the Phase 1B category. Relevant medical history included ongoing type 2 diabetes mellitus, which was diagnosed 10-15 years prior reporting, had a watchman procedure on an unspecified date, and had used a cane to walk before. Concomitant medication included clopidogrel as a blood thinner from 15Jan2021 and ongoing, which he would take for 6 months. The patient previously took apixaban (ELIQUIS). It was reported that he had a watchman procedure and they took him off of apixaban and started him on clopidogrel. In 6 months, he would not have to take any blood thinners and would make an appointment with his physician. On 18Jan2021, at noon, the patient was experiencing pain in his right groin. As the day progressed it got worse. By night (18Jan2021), he was in extreme pain and had difficulty walking. He had to use a walker to walk. It had let up, but he still had pain in the groin of his right leg. The patient was asking if there were certain doctors that could assist him with this problem. He was no longer using a walker. He was using a cane instead. He used a cane to walk with before this, but not for this reason. He never had any real serious aching. He had a little soreness in his arm on an unspecified date in Jan2021, but nothing out of the ordinary. He didn't know his arm was sore until he rubbed it. He though it might have been on Sunday when he noticed it. He was not sure. Prior to this, he had redness on the toe of his left foot on an unspecified date in Jan2021. He was prescribed an antibiotic that he was still taking. He was unable to provide the name of the antibiotic. Therapeutic measures were taken as a result of "difficulty walking and redness on the toe of his left foot. The patient had no investigation assessment. The patient was recovering from the event "pain in right groin," he was not recovered from the event "difficulty walking," while the outcome of the events "arm soreness and redness on the toe of his left foot" was unknown.

An itch on the left side of his abdomen; A single 'hive'; This is a spontaneous report from a contactable pharmacist. An 86-year-old male patient started to received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3247), via intramuscular route in the right arm from on 21Jan2021 08:00 (at the age of 86-years) as a single dose for COVID-19 immunization. Medical history included hypercholesterolaemia, hypertension, hypothyroidism. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medication included acetylsalicylic acid (ASPIRIN LOW), atorvastatin calcium (ATORVASTIN), metoprolol, levothyroxine sodium (SYNTHROID). On 21Jan2021 at 09:45, the patient developed an itch on the left side of his abdomen that became a single hive approximately 5 -10 mm. The patient was treated for itch and hive with levocetirizine 5 mg. The clinical outcome of the event itch and hive was recovered in Jan2021.

Fever and non-pruritic rash lower back developed on 1/25/2021 - resolved Localized pruritic maculopapular rash right proximal arm developed 1/31/2021

Rash around base of neck and upper chest area began day after 1st shot but attributed it to warmth at night. Same happened after second dose and continues. To visit dermatologist on Wednesday Feb 10, 2021.

For about 12 hours he itched all over. When he got up in the morning his shoulders and ankles also ached. When he moved around the muscle discomfort was relieved, but would come back when he was not moving his joints. Around 10 AM, he sat in a hot tub about 45 minutes, then applied body lotion and was relieved. Neither the itch or muscle aches returned.

8 hours post first covid vaccine patient wife called emergency room stating patient began complaining of itching, several minutes later noticed red and pimply bumps all over skin. Extremely itchy and uncomfortable. Denied fever or difficulty breathing or swallowing. Recommended by triage nurse to be seen in ED.

covid shot estimated at Feb 1st between 1-2 PM, first shot, and then had a trip and fall that day. 3-5 days later noted cellulitis on his leg with redness, swelling, pain, edema and went to urgent care on the 10th, given some antibiotics which he is currently taking and the site is looking much better. Patient notes also painless nodules going down his bicep, but not where lymph nodes are (more in the middle of the arm from the site, not near elbow or armpit). Pt also noted some bruising initially at the injection site which is better. Should he still get his second shot even with the abx and cellulitis? Adv cellulitis on the leg more related to the fall than the shot. The nodules could be from the shot but as they aren't where I would typically expect to see lymphadenopathy would rec FU with PCP if the nodules persist or worsen. None of this is a contraindication to getting the second dose of the vaccine, but inform the vaccine providers that you are on elliquis so they can be aware to watch for additional bruising/bleeding, which is common after the shot. Discussed also Q518.

bleeding internally in small intestine; cut Eliquis in half; rash on shoulder and neck; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-013205) license party for apixaban (ELIQUIS). This case was received via Pfizer Inc (Reference number: 2021125505) on 05-Feb-2021 and was forwarded to BMS on 08-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of SMALL INTESTINAL HAEMORRHAGE (bleeding internally in small intestine) in 86-year-old male patient who received apixaban (Eliquis) tablet for an unknown indication. The occurrence of additional non-serious events is detailed below. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for Prevention. Product or product use issues identified: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (cut Eliquis in half). Concurrent medical conditions included Gout (diagnosed two or three years ago). On an unknown date, the patient started Eliquis (Oral) 2.5mg half tablet by mouth twice daily. On 07-Jan-2021, the patient started Covid-19 Vaccine (Intramuscular) intramuscular injection in right arm. Further treatment periods at the same dose started on 01-Feb-2021. In January 2021, the patient experienced RASH (rash on shoulder and neck). On an unknown date, the patient experienced SMALL INTESTINAL HAEMORRHAGE (seriousness criterion medically significant). The patient was treated with salicylic acid (Eucerin [Salicylic Acid]) for Rash. The action taken with Eliquis(Oral) was unknown. At the time of the report, SMALL INTESTINAL HAEMORRHAGE outcome was unknown and RASH did not resolve. Cardiologist recommended patient to take apixaban for palpitation of the heart that he has every so often. Eliquis at 2.5mg tablet twice a day and then patient found out he was bleeding to death, clarifies he was bleeding internally in his small intestine. So he cut his Eliquis in half and he was currently taking half of 2.5mg tablet twice a day. He got the Pfizer covidl19 shot. He has developed a rash on his shoulder and neck. He also stopped using his laundry soap since he was not sure if it was his laundry soap. For Eliquis(Oral), the reporter did not provide any causality assessments.; Sender's Comments: BMS Medical Evaluation Comment: This patient had small intestine hemorrhage while on apixaban. Based on the anticoagulant nature of apixaban, its contributory role in small intestine hemorrhage is considered possible.

skin irritation and discoloring; skin irritation and discoloring; severe hives; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (right arm) on Jan2021 at single dose for Covid-19 immunization. The patient's medical history included Heart (heart disorder), diabetes, and allergy: life long allergies. The patient concomitant medication includes unspecified medication. The patient previously took Zocor, Cardura, Accupril, Niacin, Clonidine HCl; all tabs and experienced allergies. In Jan2021, the patient experienced skin irritation and discoloring starting the day of vaccine and increasing into severe hives the following days. Currently on day 6 with no relief. The patient did not received treatment for the events. The outcome of the events was not recovered. The reporter assesses the events as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information on the Lot/Batch number has been requested

DATE: 02/20/21 12:00AM - AWOKE WITH SEVERE ITCHING ON WRIST OF BOTH ARMS 12:00 - 12:45AM - STAYED AWAKE WHILE IN BED ITCHING BOTH ARMS 12:45AM - WENT TO BATHROOM TO A VISUAL VIEW OF ITCHING ARM. BOTH ARMS, WRIST TO ELBOWL, WERE EXTREMLY RED "RED" DOTS OVER WHOLE BODY FROM THE THROAT DOWN; NO SPOTS OR REDNESS ON THE HEAD OR FACE. SLIGHT PRESSURE ON CHEST. APPLIED CERAVE LOTION ON MULTIPLE AREAS OF THE BODY, WHICH PROVIDED INSTANT RELIEF. DRANK A CUP OF BIGELOW MATCHA GREEN TEA WITH TURMERIC. WEN TO BED AT 02:00AM UNTIL 07:30AM. ALL PROMBLES ABOVE WERE GONE. SKIN LOOKED THE SAME AS LAST EVENING AT BEDTIME 10:30PM.

pt states about a week after he got the covid vax he developed a head ache and a rash all over his body from head to toes. Pt went to PCP on where he was prescribed Triamcinolone acetonide cream USP 1%. It temporally eases the itching but rash has only gotten worse. Pt is going to Dermatologist on 3/16/2021 since his rash is not getting any better.

First of all, the second dose may be FM - it was cut too close for me to tell. His problem was severe itching across the back and down the back to below his waist. Itching on shoulders and down below the underarm, some on legs/arms. It started around the time of the vaccine and was starting to get better, then he got the second shot on Feb 10 and he's still itching today but not as bad. He did see his heart doctor after the first shot and the nurse also had some itching. We also went to see a dermatologist and he couldn't figure out what the cause was. His back/shoulders/arms/legs had red splotches all over where the itching was. Not exactly a rash but small up to medium sized - about the size of one's fingernail, and raised a little bit. All this was why he went at least a month only taking his necessary heart medications and then he went back on the regular stuff but the itching is still there, although not as irritating now as before.

2/27/21 hpi86 y.o. male with a past medical history notable for Dementia, hypertension, hyperlipidemia, recent skin breakdown. The patient presents for evaluation of worsening issues of cellulitis and acute renal failure skilled care facility. Due to patient's dementia other history could not be taking. Patient has had decreased intake. Patient has had some worsening issues with skin breakdown. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Patient does show signs of discomfort with his bottom. Patient otherwise appears to be at baseline. Hospital Course: patient was admitted to the hospital for worsening dehydration and finding UTI and pneumonia. The patient is also found have skin breakdown. The patient was placed and patient is started on IV fluids and IV antibiotics and wound care was started on patient. Patient did have some issues with behaviors but this was improved with treatment. 3/20/21 readmission acute renal failure

I had redness, warmth, tenderness and swelling of my right leg. I was hospitalized to received IV antibiotics.

Within 15-minutes of vaccination, the patient reported pruritic, erythematous hives on his face and chest. EMS evaluated the patient on-site. EMS administered 50mg IM Benadryl and placed patient on O2lpm via nasal cannula. Patient was hypertensive (161/84) with a FSBG of 134mg/dl. EMS transported the patient to Emergency Department for further evaluation. In the ED, the patient reported that after receiving the IV Benadryl, their facial flushing, redness, and hives have disappeared. The patient did continue to have some generalized itching. The patient remained hypertensive (163/83). Physician administered 20mg IV Pepcid and 125mg IV SoluMedrol. Patient reported improvement and was discharged with a diagnosis of allergic reaction - improved. Physician prescribed Benadryl 25mg PO QID, Pepcid 20mg PO BID, and Prednisone 40mg PO QD for 4-days.

03/22/21: Patient presented and was admitted through ED for pain, redness and swelling to his left lower extremity which began 2 weeks ago. Patient had left leg ischemia with rest pain and foot ulcers. patient was on outpatient antibiotic treatment for same problem. Per the EUA, hospitalization are to be reported irrespective of attribution to vaccine.

her husband's pain is more in his right elbow and right shoulder/pain is more like a joint pain; right arm pain started with the COVID-19 Vaccine injection site/pain is in his right (dominant) arm; husband is experiencing a sore arm, husband's arm has been sore as worsened; This is a spontaneous report from a contactable nurse. A 86-year-old male patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269), via intramuscular route of administration, administered in Arm Left on 03Feb2021 14:15 as single dose for covid-19 immunization. Medical history included was none. Concomitant medication was not reported. Upon follow-up (16Mar2021): it was reported that, first dose of Pfizer covid-19 was shot on an unspecified date at 14;15 PM via intramuscular route of administration in right arm of Batch/Lot number: EL9269. She said her husband's arm has been sore for 8 days. Her husband's arm has been sore for 8 days was reported as worsened. She said her husband tried Advil, Tylenol, hot packs, cold packs, and nothing seems to help his sore arm, and pain was in his right (dominant) arm, the pain was more in his right elbow and right shoulder, and her husband's pain is more like a joint pain. She said her husband has a high tolerance for pain, and normally doesn't take anything for pain. She said her husband can't put his jacket on because he is unable to lift his arm due to the pain in his right elbow and right shoulder. She said her husband has been trying everything, and nothing seems to help his right elbow and right shoulder pain much. Clarified her husband's right arm pain started with the COVID-19 Vaccine injection site and then the pain moved into his right shoulder and then into his right elbow. Reported her husband had a CAT scan of his head and neck on 01Feb2021 checking for blood clots. She said the results of the Head and Neck CAT (Computerised tomogram) Scan were normal. Reported her husband's second COVID-19 Vaccine dose is scheduled for 24Feb2021. The reporter classified the event husband is experiencing a sore arm and husband's arm has been sore as worsened as disability and other events was not reported and assessed the causality between the event husband is experiencing a sore arm and husband's arm has been sore as worsened the vaccines as Related. Upon follow-up, it was reported that, the patient has a very sore arm for about 8 days but then it resolved and no trouble since then. His second shot did not have much of a reaction and both are fine now. Therapeutic measures were taken as a result of husband is experiencing a sore arm and husband's arm has been sore as worsened and included treatment with ADVIL at a dose of 200 mg (Lot Number: W36210, Expiration Date: Nov2019), TYLENOL, at a dose of 500mg, hot packs and old packs. Upon follow-up (16Mar2021), the outcome for the events were recovered on 11Feb2021. Follow up (16Mar2021): This is a follow-up spontaneous report received from a contactable nurse includes, updated information about the first dose of Pfizer vaccine, route of administration for the second vaccine and the outcome for the events. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Considering temporal relationship and known safety profile, the reported pain in arm was likely causally related to the vaccination with BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

immediate soreness at injection site and worsened as time went on. Pain severe on shoulder movements at times, arm feels asleep and a lump developed on the inner aspect of the elbow.

Patient's wife noticed red blotches on his arm and suspected hives. Patient brought back to Med OBs at 2:55, he was alert and vital signs were: HR: 63, BP: 134/51, SPO2: 99. denied itchiness, SOB, throat tightening, palpitations. Scattered dry, red blotches on bilateral arms. Examined legs, back, and chest, no other blotches noted. Had patient wait with us for observation. At 1545 rechecked vitals: HR:65, BP:128/55, SPO2:98, patient had no further redness and continued to deny any symptoms. he felt he was ready to go home. discharged to home with wife. consulted patient and wife he could take Benadryl.

This 86 year old male received the Covid shot on 1/20/21 and went to the ED on 1/23/21 and was admitted on 1/23/21 and again went to the ED and admitted on 4/4/21 and again to the ED on 4/26/21 with the diagnoses listed below and died on 5/4/21. D50.0 - Blood loss anemia I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC) S09.90XA - Closed head injury, initial encounter W19.XXXA - Fall, initial encounter S01.01XA - Laceration of scalp, initial encounter S06.5X9A - Subdural hematoma (CMS/HCC) S06.5X9A - Traumatic subdural hematoma (CMS/HCC) Z74.09, Z78.9 - Impaired mobility and ADLs

rash on his right arm (opposite the injection site); but they are sensitive and haven't went away; it is just a smooth redness; his right forearm broke out in smooth, red spots; This is a spontaneous report received from a contactable consumer (Patient). A 86-year-old male patient received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number: ENL318 Expiration date: unknown), via an unspecified route of administration, in Arm Left on 05Feb2021 as 1st dose, single for covid-19 immunisation (for prophylaxis). The patient medical history included ongoing asthma diagnosed when he was 39 years old and ongoing atrial fibrillation diagnosed about 16 years ago. Patient had taken 7 drugs, and he had been taking them for years and never seen any side effects from them. patient had not received any other vaccines on the same day as the COVID vaccine. On 07Feb2021, patient experienced he had broken out on the inside of his right forearm, with a rash, He has a rash on his right arm (opposite the injection site),, but it is not bumpy, it was just a smooth redness that measure about 3-4 inches in diameter, just below his elbow on the inside of his right forearm that does not have any extra heat, but it was sensitive to the touch and haven't went away. it was reported that, Rash had mostly stayed the same, but if anything, it was slightly improved. Patient was due for his second dose on 26Feb2021. He had not talked to his doctor but used some cortisone on it to treat. The outcome of events his right forearm broke out in smooth red spots, rash on his right arm (opposite the injection site) was recovering while other events were not recovered. Follow-up (09Feb2021): This is a follow-up spontaneous report from a contactable consumer., new information included suspect product, events detail, batch no. medical history. Follow-up attempts are completed. No further information is expected

Patient was admitted for management of leg hematoma. He originally presented to the emergency department on 5/12/21 with a leg contusion. He presented to the emergency department again on 5/18/21 for worsening infection of contusion. He was COVID-19 negative at that time with no symptoms. During admission, he was found to be COVID-19 positive during screening before procedure. He remains asymptomatic. He is still admitted at time of writing.

severe hives; skin rash on arms; This is a spontaneous report from a contactable consumer (patient), in response to Non-HCP letter sent in cross-reference case. An 86-year-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6200 and Expiration date was not reported), via an unknown route of administration in right arm on 16Feb2021, as 2nd DOSE, SINLE for COVID-19 immunization. The patient received of BNT162B2 (Lot number: EN5318 and Expiration date was not reported), dose 1 via an unknown route of administration in right arm on 26Jan2021, as SINGLE DOSE for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On 17Feb2021 the patient experienced severe hives and skin rash on the arm day after second dose of vaccination, mostly in the arms. Skin doctor recommended vera cream, anti itch pill, an ointment. Patient was still experiencing the event. The patient visited physician office for treatment of events. There was no surgery planned prior to vaccination. There were no predisposing factors, and no culture was performed. The outcome of the event was reported as unknown. No follow-up attempts are possible. No further information is expected.

moderate pain in left arm following first injection; This is a spontaneous report from the contactable nurses. An 86-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), intramuscular administered on arm left on 03Mar2021 11:00 (Batch/Lot Number: EN6206) as 1ST DOSE, SINGLE for COVID-19 immunization at the urgent care facility. Ongoing medical history included cerebrovascular disease, dementia, essential hypertension, type II diabetes mellitus (DM), constipation and pain. Concomitant medications included senna acutifolia (SENNA ACUTIFOLIA) taken for constipation from an unspecified start date and ongoing; acetylsalicylic acid [ASPIRIN (E.C.)] taken for cerebrovascular accident (also reported as decrease stroke risk) from an unspecified start date and ongoing; glimepiride (GLIMEPIRIDE) taken for type 2 diabetes mellitus from an unspecified start date and ongoing; ibuprofen (IBUPROFEN) taken for pain from an unspecified start date and ongoing; and losartan (LOSARTAN), amlodipine (AMLODIPINE), and metoprolol succinate (METOPROLOL SUCCINATE) all three taken for blood pressure/essential hypertension from unknown dates. On 03Mar2021 11:00, the patient had moderate pain in left arm following first injection. The event was considered as serious (life threatening and persistent/ significant disability/ incapacity). Outcome of the event was not recovered.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported vaccination site pain. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.

arm is red around where he got the shot/ arm is all red; It feels a little warm.; This is a spontaneous report from a contactable consumer(wife). A 86-years-old male patient received bnt162b2 (PFIZER-BIONTECH, COVID-19 vaccine, formulation: solution for injection) via an unspecified route of administration, administered in Arm Left on 05Feb2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medication were not reported. In Feb2021, the patient's arm was red around where he got the shot and it felt a little warm. It was about a 4-inch circle.The reporter stated that It was not red Saturday and don't know about it on Sunday,but when he got out of the shower on 08feb201 (day of reporting) his arm was all red. The patient's wife asked was this normal, is there anything she should be aware of for him. The reporter explained it was on the left arm and this was the side that he got the shot on. Outcome of the events were unknown. Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected.

Large lump hard "3 inches. Does not bother unless he puts pressure.; His arm is swollen where he got the shot; This is a spontaneous report from a contactable consumer or other non-HCP (patient's wife). An 86-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration on 05Mar2021 (age at the time of vaccination 86-years-old), as a single dose for COVID-9 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date, the patient experienced Large lump hard "3 inches. Does not bother unless he puts pressure; and His arm is swollen where he got the shot. Patient did not received treatment for adverse events. Caller stated, should he take the second dose. The outcome for all the events was unknown. No follow-up attempts are possible. No further information is expected.

Rash noticed by PCP during annual assessment. Patient had a pink red pimply rash with numerous scabs on his front torso and back. The patient was very itchy during the physical exam on 1/12 and was unaware he had an extensive rash. As of 1/18/21, patient has been scheduled for follow-up with dermatology to determine whether rash was due to allergic reaction. Patient is in stable condition at his ALF, and is still recovering from the rash.

Received Pfizer Covid vaccine on January 13, 2021. I noticed a rash across shoulders and back on 1/15/21.

Patient called our clinic to report swelling and redness of the left hand. He said this symptom started several days after receiving the vaccine at an outside location. Symptoms gradually worsened over the last few days until his hand became so swollen that it became difficult to make a fist and is impairing his activities of daily living. Reaction seems to be localized to the hand and patient reports no other symptoms.

Site of vaccination was uncomfortable immediately following the vaccination, and in the days following developed a red, swollen patch in the vaccination site.

inddividual had a reaction of hives across back and down his right arm about a week and a half after vaccination

Received vaccine on 1/21/21 1/30/21 caller notified his wife that he had hives on his back and right arm. Wife states it could have happened sooner because he has dementia and has difficulty keeping days and times straight. Itchy and color is not as red as with Aspirin reaction, looks like a small back dot in the center of the hive. They have slowly gotten better as time has gone on and they appear mild now (2/4/21)

Left arm turned red from my shoulder to my elbow. Like a big bruise , Pain in the shoulder and where the shot was given. Still have pain and redness 02/10/21. Pain keeps me from sleeping at night.

EMS WAS CALLED PATIENT BECAME WARM BUT CLAMMY, PALE AND LETHARGIC WHEN EMS ARRIVED PATIENT WAS ALERT AND RESPONSIVE

Itchy skin rash; This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 19Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included thyroid, high blood pressure and cholesterol from an unknown date and unknown if ongoing. The patient has no known allergies to medications, food, or other products. Concomitant medication included levothyroxine, lisinopril and atorvastatin. The facility where the most recent COVID-19 vaccine was administered was not specified. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced itchy skin rash on 29Jan2021. The outcome of the event was not recovered. No treatment was given to the patient for the events. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and was not a congenital anomaly/birth defect.

death Narrative: 86 year old MALE with PMH of Afib s/p AICD/PPM, HFrEF (EF< 20% 10/2019), DM2, HTN, HLD, BPH, Depression. Was stable and feeling well when he was administered Covid-19 vaccine on 02/17/2021- Pfizer COVID-19 Vaccine 0.3 ml IM. MVX (Manuf); PFR; Lot#; EL9267; Exp Date:05/31/2021 Administration Anatomic site: Right Deltoid; Pt was monitored for 30 minutes after administration and had no adverse effects. He was called later in the day and reports he feels well and has had no adverse reactions, he endorsed his arm is a little sore at injection site. ON 02/19/2021- his dghter found him on the floor, next to his bed, dead. She reported on 2/19/2021- that she was out with him to dinner on 2/18/2021, and he stated he did not feel well, that his insides did not feel right. He proceeded to have dinner and 2 drinks. HE was doing ok, when she took him home.

fall; bruised rib; bruised hip; This is a spontaneous report from a contactable consumer (reporting for his father). An 87-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date: 30Apr2021), via an unspecified route of administration into the left arm on 12Jan2021 at a single dose for COVID-19 immunisation (COVID prevention). The patient's medical history included Alzheimer's disease and stroke. There were no concomitant medications. The reporter was calling regarding his father who was an 87-year-old combat veteran. The reporter stated that the patient received the first dose of the Pfizer COVID Vaccine on 12Jan2021. The patient was scheduled for his second dose on 02Feb2021, but they had to cancel that appointment because the patient was in the hospital from a fall he had on 29Jan2021 where he bruised his hip and bruised his rib. The patient was hospitalized from 30Jan2021 and was released from the hospital on 05Feb2021. The reporter stated that the clinic said they are not able to make any more appointments right now. The reporter was wondering if there were consequences of, or a danger in, getting the second dose outside of the recommended timeframe. The patient is now on a waiting list to get the second dose and he would like to know how far past the recommended 21 days can he go and still have the vaccine be effective. The patient received no other vaccines on the same day as the COVID vaccine. The patient has had an MRI before where it was indicated that there were some spots from a past stroke. The reporter stated that no paralysis has been identified. The outcome of the events was unknown.

Swelling at site of injection. Started within 1 hour of injection (noted on ride home). Swelling increased, and pain increased, a day later. Arm still swollen, less so, two days after injection. Pain reduced but still present two days after injection. Advised ice pack yesterday. Swelling seems to have gone down by 56 hours after injection, only slight. (but has lasted past 48 hours.

2/26/21 rash resolved. 2/19/21 Red areas are improving and starting to peel. I was able to soak his feet and wash areas that are peeling. Applied lotion. 2/16/21 Updated Dr. He said to give Benadryl 25 mg three times a day. Also use his triamcinolone cream BID and update if it doesn?t work. (Explained to Dr. it looked like Stevens Johnson syndrome.) 2/15/21 Pt has a very red/ blistery looking rash on his lower legs front and back. Red groin, flank area, inner arms, C/O itching. We think it is caused from Covid vaccine he received on 2/13/21. Benadryl ointment applied.

his arm is hurting; he experienced injection site discomfort during administration of the vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare professional via Medical Information Team. An 87-years-old male patient (Husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL1283) via an unspecified route of administration in left arm on 14Jan2021 and second dose on BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL8982) via an unspecified route of administration in left arm on 04Feb2021 at 17:30 both as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 04Feb2021 05:30 pm, the patient experienced injection site discomfort during administration of the vaccine and on an unspecified date, patient experienced his arm is hurting. Reporter mentioned that the same thing happened on the first shot. Outcome of the events was resolved on unspecified date in 2021.

some inflammation on neck part skin; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient himself) reported that an 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 16Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the caller, called to ask if it was okay for him to take the antibiotics (Cefalexin) prescribed to him by his physician due to some inflammation on neck part skin on an unspecified date in 2021 for 7 days before his second dose schedule on 06Apr2021. The outcome of the event was unknown. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.

Symptoms started with headache and fatigue. After a couple of days, developed fever that lasted 3 days. On the last day of the fever, rash developed all over body and pain around the parotid gland. Two days ago, developed swollen hands and ankles. Was given antibiotic and told to take OTC allergy medications.

bruising pain in the muscle on the left arm; bruising pain in the muscle on the left arm; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 87-year-old male patient received first dose of bnt162b2 (BNT162B2, Pfizer COVID 19 Vaccine), by injection via an unspecified route of administration, administered in Arm Left on 01Apr2021 noon (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. The patient medical history was none. Family History was none. The patient's concomitant medications were not reported. The patient experienced bruising pain in the muscle on the left arm started at noon or short time after on 01Apr2021 with outcome of recovered in Apr2021. The clinical course was reported as follows: Caller states he was down there a week and a half ago to the health center SSM to get his shot. He is hearing all kinds of things on TV. Mentions he is 83 years old, later corrects to 87 years old and in good shape. Adds he only had bruising pain in the muscle on the left arm that happened almost right away and went away in a day or two. Adds his daughter and son-in-law were upset with their physical being by themselves in they are in their late 50s and 60s. He is asking should he get the second shot? Adds he is He is due to come back on the 15Apr2021, later corrects to 19Apr2021. States he received the first dose of the Pfizer COVID 19 vaccine on 01Apr2021 at noon in his left shoulder muscle. He is supposed to go back next Monday on 19Apr2021 for the second dose. Mentions his wife died a year ago and he is a Christian and he knows he is going to be with his wife in heaven. Adds she had the thing where they put the thing in her arm and you go three days a week. She has a cleaning out of the thing and he never saw her again. He didn't get to say goodbye. Adds she died on Easter Sunday. Mentions he is going to see his doctor very soon. Adds he has had no signs of COVID. Asking is it okay for him to not get the second dose. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none.No AE(s) require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. Relevant test was none No follow-up attempts are needed. No further information is expected.

Hives; This is a spontaneous report from a contactable consumer (the patient). A 87-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: E69265), via an unspecified route, administered in right arm on 03Feb2021 13:30 (at the age of 87-year-old) as a single dose for COVID-19 immunization. Medical history included aortic valve disease from an unknown date and unknown if ongoing, cardiac pacemaker insertion from an unknown date and unknown if ongoing, eye injury from an unknown date and unknown if ongoing. Allergic to products tetanus, penicillin, sulfa and codeine. Concomitant medications included dulaglutide (TRULICITY), lisinopril (LISINOPRIL), clopidogrel (CLOPIDOGREL), rosuvastatin calcium (CRESTOR), metformin (METFORMIN) all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination, the patient had not been tested for COVID-19. On 04Feb2021 05:00 PM, the patient experienced mild hives from something in the medications he had been taking but the next day, Thursday, after the Pfizer vaccine increased hives breaking out in new locations. He had a history of reactions. Discussed this with the nurses prior to receiving the shot. The patient did not receive any treatment for hives. The outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.

About three days after getting the vaccine I started getting blisters on my right lower leg, and it just kept growing. The blister broke and and became and open wound. I went to the dermatologist and they gave me some ointment, but that didn't really help. I went through doctors, and now a nurse comes to treat the wound.

Chills; mild fever; Right arm became red, hot, and very painful; Right arm became red, hot, and very painful; Right arm became red, hot, and very painful; swelling got worse; The pain got worse after the second vaccine; BP became low; This is a spontaneous report from a contactable physician. A 87-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6206), dose 2 via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:30 (at the age of 87-years-old) as dose 2, single for covid-19 immunisation. The patient previously received dose 1 (lot number EN6201) via an unspecified route of administration, administered in Arm Left on 10Feb2021 as dose 1, single for covid-19 immunisation and experienced pain in the right shoulder which gravitated to the elbow, forearm and hand, tha opposite side of the vaccine site. Medical history included atrial fibrillation, food allergy. The patient had no other vaccine in four weeks. The patient was not covid prior vaccination. Concomitant medications included amiodarone; nebivolol hydrochloride (BYSTOLIC); azilsartan kamedoxomil (EDARBI). On 10Mar2021, the patient experienced the "pain got worse after the second vaccine", bp became low, Right arm became red, hot, and very painful, and on an unspecified date chills and mild fever. It was reported that the pain got worse after the second vaccine shot on 10Mar. Right arm became red, hot, and very painful (9 on 0 to 10 scale). Pain and swelling got worse the arm became totally useless, unable to make a fist or even just hold a pencil or a toothbrush. Took Tylenol to get pain relief on day 3 after the shot ibuprofen taken on day 4 after shot. Now on day 5 hand still is swollen and painful but improved enough to hold a pencil and type on keyboard. Additionally, starting on day 1 of second shot BP became low - 110/55 and remained low 120/60 even after all antihypertensive medications were discontinued. His normal BP is in the range of 140-160 systolic and 70-80 diastolic. Chills and mild fever for 6 hours happened on day 2 and for 3 hours on day 3. Temp readings not taken. Patient did not test for covid post vaccination. The patient underwent lab tests and procedures which included blood pressure diastolic: 70-80, blood pressure measurement: 120/60, blood pressure measurement: 110/55 on 10Mar202, blood pressure systolic: 140-160, pain assessment: 9 on 10Mar2021 (9 on 0 to 10 scale). Outcome of the events were recovering. No follow-up attempts are possible. No further information is expected.

irregular red, not raised from face, neck, anterior and posterior chess abdomen and back anterior; Itching; This is a spontaneous report received from a contactable physician. An 88-year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249) via intramuscular route of administration in the left arm on 21Jan2021 at 12:00 as single dose, for COVID-19 immunisation. Medical history included hypothyroidism and glaucoma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) and brimonidine (ALPHAGAN P) for unknown indication. The patient did not receive any other medications or vaccines within 4 weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH7899) via intramuscular route of administration in left arm on 31Dec2020 at 10:45 as a single dose, for COVID-19 immunisation. On 01Feb2021, the patient had irregular red, not raised from face and neck, anterior and posterior chest abdomen and back anterior and posterior thigh size 4 to 6 cm covering 90% of area with marked itching. The adverse events did not result in doctor or other healthcare professional office or clinic visit or emergency visit. The patient was treated with Benadryl 25mg (1 in 4 hours) and hydrocortisone (1 in 8 hours) for the reported events. The clinical outcome of events irregular red, not raised from face, neck, anterior and posterior chess abdomen and back anterior and itching was resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Approximately 1 week after vaccination patient developed swelling and blistering rash overlying left arm. Subsequently developed significant pain and weakness in his arm, with contractures present.

Vaccine given on 12/29/20 by Pharmacy. On 1/1/21, resident became lethargic and sluggish and developed a rash on forearms. He was a Hospice recipient and doctor and Hospice ordered no treatment, just to continue to monitor. When no improvement of codition reported, doctor and Hospice ordered comfort meds (Morphine, Ativan, Levsin). Resident expired on 1/4/2021

swelling of right arm, where he received the vaccine; Palpable purpura/Some of the purpura was on the left arm and he had a few spots on the upper chest; Blistering; This is a spontaneous report from a contactable physician. An 88-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm on 09Jan2021 at single dose for COVID-19 vaccination (reported as for "1-B vaccine group, age greater than 75, history of heart disease") in hospital. Co-suspect drug included apixaban (ELIQUIS) orally from 2020 (Has been on Eliquis for over the last year, 12 months) and ongoing at 5 mg, 2 times a day (5mg, 1 tablet by mouth twice daily) for heart failure and atrial fib. Medical history included heart failure, atrial fib. Concomitant medication was not reported. No other vaccines given the same day or 4 weeks prior. Mentions patient did have a flu shot back in Sep2020 (unable to provide NDC, Lot, or expiry), no problems with vaccines in past. Patient received the first dose Saturday morning of 09Jan2021 with no ill effects. 3-4 days later (Jan2021) patient had swelling of right arm, where he received the vaccine, and then developed palpable purpura. Some of the purpura was on the left arm and he had a few spots on the upper chest. Had no fever, no malaise, just what the patient described as blistering and so they had a dermatologist look at it. All seems to be improving. They were curious as to what this is. The patient feels fine and is ambulatory and the purpura does not itch. Caller does not provide seriousness criteria when queried. Initially it was thought, because the patient was on Eliquis for heart failure and atrial fib, that the Eliquis was related to events, but when the Dermatologist looked at it and stated it maybe excavation they decided to call and find out what Pfizer wanted them to do. Caller states he can give a list of medications if needed. Says patient had a comprehensive biochemical profile done non fasting also on 18Jan2021. Patient was seen by him initially on 19Jan2021. Wants to know whether this is a safety concern or/and if the patient should have the second dose. event requires a visit to physician office. Lab test on 18Jan2021 included Comprehensive Biochemical Profile, Blood Sugar of 116, Creatinine of 1.91, BUN of 43. Action taken of apixaban was dose not changed. Patient was recovering from the events. Relatedness of drug to event swelling of right arm, Palpable purpura and Blistering, feels fine, ambulatory, no fever, no malaise, seen by dermatologist, purpura does not itch, on Eliquis. Per Source of assessment (Primary Source Reporter) and Method of assessment (Global Introspection) for drug result (Covid-19 vaccine) was Related, of drug result (Eliquis) was unrelated. Information on the lot/ batch number has been requested.

Bruising at or near injection site. Muscle area below was discolored, yellowish, as if there had been bleeding in the muscle. No pain or discomfort during or after injection. Site was not examined until discoloration was observed by wife about 5 days after the injection (2/13/2021) when he came out of shower. The discoloration covers a circular area of about 1.5" diameter. The red area at the top of the circle has not subsided. Observed by a physician during routine office visit for another purpose on 2/16.

he is coughing now; soreness in muscle on site on injection; This is a spontaneous report from a contactable consumer. An 88-year-old male patient (husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL9261, expiry date: May2021), intramuscular on 23Jan2021 11:30 AM at 0.3 mL, single on left deltoid (reported as "0.3ml by IM (intramuscular) injection once to in left shoulder, the usual place") for COVID-19 immunisation (reported as "88 and they are not anxious for him to get COVID/he has deep lung disease and if he didn't get it, he may die from it"). Vaccination facility type was a special clinic set up by hospital. Vaccine was not administered at facility. Medical history included deep lung disease, total reverse shoulder surgery in Jul2020, asthmatic, lung problems. Patient has no compromised immune system. Patient's only allergic reaction was old tetanus (tetanus toxoid) but he was really fine. Patient had tetanus toxoid in 1950, he was a very young man and he has not had it since then, the reporter does not believe they give it anymore. No family medical history relevant to adverse events, also reported as "No, but there is no history for the COVID vaccine, we are only 3 months into it". Concomitant medication included omalizumab (XOLAIR) for lung problems and asthmatic. No additional vaccines administered on same date of Pfizer product. After the first 3 days, patient got the vaccine on 23Jan2021. Patient is now on day 9 but the first 3 days after, he had no side effects. On the 4th day (27Jan2021), he developed soreness in his muscle on the site of injection, and the next day it was increasingly sore, on the 28Jan2021, 29Jan2021, 30Jan2021, and was quite incapacitated, he could not use it, it was really bad, now he was beginning to improve. The reporter wanted to Pfizer to know the length and depth. It only had to do with the use of the muscle not, he was not suffering when not using the arm, a couple days were really bad, he did feel it when he was not using it, but most of the time, the pain came when he needed to use it. The reporter talked to enough who said don't worry, but patient had a total reverse shoulder surgery in Jul2020, in that arm and asked "could that injection exacerbate anything going on there? Most doctors said to not worry about it". The reporter wants to help COVID. The reporter got hers minute after his husband and she had no side effects whatsoever, so if there was any question about something going on at the site, she could not imagine hers would be so perfect. The event did not require emergency room and physician office visit, further reported that patient had multiple health issues. Patient was coughing now(01Feb2021), over the years, reporter has learned to deal with many things without going to Urgent Care, ER, patient was 88 and the reporter wanted to keep his husband out due to COVID. The reporter called friends who were medical doctors (MDs), as the reporter was worried, the patient was coming out of it. Patient has one injection, a new medication he was on a biologic. Patient was first refused to get the COVID vaccine due to biologic, and the day before he had received it, so they discussed and decided because of biologic, "XOLAIR". There were no adverse events prior vaccinations. Patient went on Friday for his next Xolair, he had no problems then. There were no relevant tests and was reported that patient has been there the whole time, at home, has been under quarantine since last Mar2020. If anything threw up a red flag, reporter would think it would be something they would explore, maybe for the Xolair, when this question came up, it was several days before the vaccine, patient was refused. Patient was asked if there were other injections, reporter said that his husband would have "one the one day before", and they canceled his appointment, and he went to the doctor, the pulmonologist, who administered Xolair, and reporter said that his husband was refused, the doctor said no, "it's a biologic, he was giving it to patients having the COVID vaccine, there were no interactions, and reinstated approval and everything was a go". Outcome of the event "soreness in muscle on site on injection" was recovering while for coughing was unknown.

Facial flushing and warm to touch day after injection with slight swelling and painful to touch. Physician called and Treated with Benadryl orally and Tylenol. The next morning his face was extremely swollen and small blisters present and weeping. Face extremely painful. We went to hospital and diagnosed with allergic reaction and cellulitis. Treated with oral steroid taper,Pepcid and cephalexin. He continues to treat currently for both. Instructed by healthcare provider not to get the next injection. On second steroid taper currently.

Cellulitis; Four redness with purplish lesions to the upper arm almost to antecubital; This is a spontaneous report from a contactable nurse. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202), dose 1 via an unspecified route of administration on 26Feb2021 as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed on day four (unknown date in 2021) redness with purplish lesions to the upper arm almost to antecubital. He was put on Levaquin by primary physician, the evaluation in his case was a cellulitis (unknown date in 2021). The reporter asked if the patient should get the second dose. The outcome of the events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported cellulitis 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.

Cellulitis; face was weeping serous fluid; sores; Swelling; face was so swollen; swollen cheeks; Pain in face; This is a spontaneous report from a contactable nurse. An 88-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202), intramuscular in left arm, on 25Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history included Alzheimer's and other conditions, but family did not disclose. The patient was taking unspecified concomitant medications. The patient previously took piroxicam (FELDENE) and experienced allergies. The vaccine was administered in a public health clinic or Veterans administration facility. On 25Feb2021, the patient noticed pain in face in the evening of day he was vaccinated and then the patient developed swelling by the next morning (26Feb2021). On 27Feb2021, the patient's face was so swollen that his face was weeping serous fluid and family took him to the ER. The swollen cheeks bilaterally progressed to cellulitis (27Feb2021) requiring oral steroids, famotidine (PEPCID), and antibiotics including cefalexin (CEPHALEXIN). The patient remains on steroids and creams to treat swelling and sores. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of cellulitis due to temporal relationship. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

About two weeks following my second dose of the Pfizer vaccine I developed extremely inflamed pea size hives covering my back and extending around the upper part of my body. I received medical treatment with a steroid shot, Medrol 4 mg prednisone dose pack, and clobetasol topical lotion. The inflammation diminished significantly over ten days or so.

General hives all over body- itching and blisters Hand was the worst spot- itching and opened up with clear drainage Given antibiotics and anti itch cream 2 weeks of symptoms

Soresness beginning in arm and soreness in muscle on site on injection; This is a spontaneous report received from a contactable consumer. This consumer reported for the 88 years old male patient in response to the non-HCP letter who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jan2021 at 13:00 (Batch/Lot Number: EN6201; Expiration Date: Jun2021) as single dose covid-19 immunisation . Patient's Medical History (including any illness at time of vaccination): Asthma Onset Date: 2010 Stop Date: ongoing (Pertinent Details: Cumulative, resulting in a 6.5 hour nasal cavity remaining & removal of polyp in 2013), Aspergillus fumigatus and Cardiac disease Onset Date: 2014 Stop Date: ongoing (Pertinent Details: heart valve replacement), Surgery history: In 1965 bi-lateral carpal tunnel relief, 06Jul77 bi-lateral foot reconstruction, 26Nov80 vasectomy, 1980 bi-lateral epididiectomy, 04Jun82 Reattach first joint rt. Index finger, 1983 Groin hernia repair, 1984 Rt. shoulder rotator cuff, 24Aug1987 Rt Knee arthroscopic, 09Sep1991 Left knee hemi-replacement, 1993 Tibia and ankle reconstruction (no bone union, redone 3/94 , union finally achieved & cast off in 7/94), 18Feb1994, 15Mar1994 and 22Apr1995 Rt leg alignment surgery, 04Dec1995 Rt. Elbow, 22Jan1997 Rt. Elbow, ulnar revision, 26Jun1997 Left total shoulder replacement, 24Jul1997 Rt. Elbow screw remove & Left Shoulder prosthesis revision, 11Nov1998 Left shoulder revision, Rotator cuff, 09Mar1998 Appendectomy, 29Oct1999 Rt. Elbow, 12Sep1999 and 12Sep2001 Rt. Foot, 31Mar2002 Rt. Elbow, 22Jan2003 Left foot, 01Dec2004 Rt leg BK amputation, 29Dec2004 Stump revision, 05Apr2005 Arm Surgery, 09Apr2005 post-surgical hematoma at surgery site, 03Jul2006 Dupatron left ring finger, 21May2007 Rt. Knee partial, left knee total replace, 21Sep2007 Knee Surgery, 10Mar2008 Rt. Elbow (revise ulnae nerve), 10Jun2010 Nasal polyp removal, 06Oct2010 Prostate TERP, 15Apr2011 Pacemaker installed, 16Mar2012 Broken right arm repaired, 30Apr2012 Left Ankle Replacement, 26Jul2013 Sinus Polyp removal (extensive 6-hour surgery), 28Aug2013 Revision: another total L ankle replacement (for failed 4/30/12 replacement), 26Nov2014 Heart: TAVR operation, 2015 Left leg BK amputation, 03Feb2017 Heart: WATCHMAN (LAAC) closure surgery and 15Jul2020 Reverse total shoulder (replacement of original replacement) Left shoulder); Hospitalization other than the above: 1934 (age 2): Popcorn grain on lung, 1960: Malaria, 1962: Viper snake bite, 2011: erratic heartbeat , 11Mar2012: Scooter Accident (11 broken ribs, punctured lung, right thigh hematoma, left arm nerve damage). Concomitant medication(s) included omalizumab (XOLAIR) taken for an unspecified indication from 15Jan2021 and ongoing. The Patient received first covid vaccination on 23Jan2021. Soreness developed 2 days later on 25Jan2021 and increased in intensity until use of arm was severely limited because of muscle soreness on day 5 (28Jan2021). It was reported that the patient was hospitalized on unknown date for the event. Soreness persisted with such intensity that his second covid shot had to be delayed (as per order of his primary core physician) until 17Feb2021. At this writing on 08Mar2021, patient arm is still very sore upon waking but is slowly improving. The patient will be 89 in May and considering several co-morbities, has done well, despite the muscle soreness. The outcome of the event was not recovered. The patient underwent relevant tests included blood tests, urine culture, diagnostic imaging (chest x-ray and MRI) on unknown date with unknown results.

it itch like crazy but the itch only lasted 5 minutes then it goes away; Hives; This is a spontaneous report from a contactable consumer (patient). A 88-years-old male patient second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9807), via an unspecified route of administration as single dose for COVID-19 immunisation. The patient's medical was not reported. patient was Allergic to Penicillin. The concomitant medication was not reported. the patient received first dose of vaccine (historic vaccine), BNT162B2 (Lot EL1283) at Left Shoulder on 25Jan2021. He experienced hives on the next day and that lasted for 3 days. The patient got Second Dose on 15Feb2021 and experienced hives the next morning, which lasted for 11 days, it is still there but going. He did not do anything to treat them, he just left them alone, it itches like crazy but the itch only lasted 5 minutes then it goes away and then different one comes up. There is no cure for Hives, that's what the doctor said. The outcome of event urticaria was resolving, whereas the outcome of event itch was unknown. No follow-up attempts are possible. No further information is expected.

Shingles; sore arm; This is a spontaneous report from a contactable consumer (patient's daughter). An 88-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (at the age of 88-years-old), administered in Arm Left on 16Mar2021 11:45 (Lot Number: EN6208) as 1st dose, single for COVID-19 immunisation. Medical history included ongoing hypertension about 20 years ago, ongoing arthritis about 20 years, ongoing hypercholesterolaemia about 20 years, pneumonia. Unspecified concomitant medications were taken ("he has been taking the same medications for many years and doesn't find his medications relevant. He isn't taking any new supplements or anything like that"). The patient previously has had the pneumonia vaccine and the flu vaccine with no problems. The patient experienced sore arm on 16Mar2021 and shingles on 02Apr2021. The patient received his first Pfizer Covid 19 vaccine on 16Mar2021. The patient had a sore arm beginning the evening of 16Mar2021 after he received his Covid 19 vaccine. Patient's daughter had asked the patient when his arm wasn't sore anymore and he said 2-3 days after the COVID 19 vaccine. The shingles started on Friday, 02Apr2021 (2.5 weeks after the vaccine) and is showing a sciatic distribution. Caller reports the shingles is worsening. He's getting new patches in his lumbar region, left buttock, left back and upper thigh. He was diagnosed with Shingles on 04Apr2021 by his primary care doctor. He has been prescribed Valtrex today for 7 days (1 gram three times daily) which will put him finishing the Valtrex on 11Apr2021. He has not started taking it. Her father's second Covid 19 vaccine is scheduled for 13Apr2021. She is asking if it's ok that her father take the Valtrex and should he push back getting his second Covid 19 vaccine a week or so. The events did not require a visit to the emergency room or physician office. Therapeutic measures were taken as a result of shingles. The outcome of the event sore arm was recovered on an unspecified date in Mar2021 while for shingles was not recovered. The events were considered as non-serious. No prior vaccinations within 4 weeks, no adverse events following prior vaccinations.

itchiness in the palms of his hands; This is a spontaneous report from a contactable consumer (patient's daughter) reported for the patient. A 89-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 11Feb2021 at 16:00 pm (age at vaccination was 88 years) as dose 1, single for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. The caller was calling on behalf of her dad who received the first dose of the vaccine on last Thursday, 11Feb2021 around 16:00 pm. The patient was fine while he was waiting at the vaccination site for 15-20 minutes and on the ride home, and when she called to check on him at 20:00 pm that evening he was fine. But when she spoke with him again she said he reported later in the evening he had some itchiness in the palms of his hands at bedtime. Itching began the same day on 11Feb2021 at 22:30 pm. She asked if that was an allergic reaction and wanted to know whether that was pointing towards an allergic. She stated that by the next morning the itching was gone, he got the shot at about 16:00 pm and then he was experiencing the itching at about 22:30 pm and then in the morning the next day, he wasn't having anything. She could not think of anything else it could been unless it was hand sanitizer. She stated that she had been hearing that the second dose was the one that can make people not feel good. She stated she was also hearing that it was more prevalent in the younger people that have more robust immune systems. She asked if that was true. The case was reported as non-serious. The outcome of the event was unknown. Follow-up (16Feb2021 and 13May2021): New information received from a contactable consumer reported for a patient included: Updated the patient's demographics, age at vaccination (88 years) and details regarding follow-up attempts (Follow-up attempts completed. No further information expected).

losing night time sleep; welts on his body; rashes on delicate parts of belly, buttocks, scalp which were itchy/The rash gradually developed an itch; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899 and expiry date: 31Mar2021), via intramuscular route of administration on 30Dec2020 at 11:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021, a week after the injection, the patient experienced rashes on delicate parts of belly, buttocks, scalp which were itchy. The rash gradually developed an itch and he is now losing night time sleep. Patient stated that there were welts on his body on an unspecified date. He tried everything to stop the itch. He later stated there were objects across the counter that he tried, not prescription. One was alcohol and the other one was peroxide and a third one is Jergen's hand lotion and none worked. The outcome of the event itchy rash was not recovered, while unknown for the other events.

On the day of the second vaccine dose patient was noted to have a large bruise on left upper arm from the first dose 3 weeks ago. Denied pain. No redness.

Injection site was little sore; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686), via an unspecified route of administration on 09Jan2021at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the injection site was little sore on an unspecified date. The patient did not receive treatment for the event reported. The patient underwent lab tests and procedures which included blood test: everything was fine on an unspecified date. Outcome of event was unknown.

Small pin holes of about 40 in left arm and 8 in right arm. Small blood spots dried but seem to be healing.

Pt began to experience bruise like spots on both hands the Saturday following injection; still apparent at time of reporting on 3/10/2021; no pain/itching or other issues in that area.

body became very itchy and he was itchy all over; developing little red like pimples all different parts of his body; itchy bumps/ little tiny pimples on his skin and it was very uncomfortable; little tiny pimples on his skin and it was very uncomfortable; This is a spontaneous report from a contactable consumer (the patient). An 89-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249, expiry date 31May2021), via an unspecified route of administration (injection) in the left arm on 22Jan2021 (at the age of 89-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was on unspecified concomitant medications. The patient stated he has been taking the same medications for several years, and he has had no problems with those. The patient did not receive any other vaccines on the same day. The patient had his first Pfizer COVID-19 shot on 22Jan2021. He was due for his second shot on 12Feb2021. After he had the first shot, his body got itchy all over and it was still itchy. He also had little tiny pimples on his skin, and it was very uncomfortable. He was wondering if this was a known reaction to the product. He had no idea what to do to relieve the itching. He got the vaccine on 22Jan2021, and the itching started either the next day or two days after getting the vaccine. His body became very itchy, and he was itchy all over. He was developing little red like pimples all different parts of his body; itchy bumps. The itching and pimples having continued through to now, and it seemed to get even more itchy in the evening at bedtime. Last night (unspecified date), he had it on the top of his feet down there, on the top and in between his toes. Those itchy bumps were all over, and he did not know if that was the Pfizer shot. The patient tried different anti-itch creams on it, and that relieved it for a while, but then it came back. He used clobetasol propionate, but it had not worked. They stopped itch for a while but then it does not help. He tried some just plain anti-itch cream (clarified as Gold Bond Anti-Itch Cream) to stop the itching. It stopped itch for a while, but then it did not help. He did not have to use the cream until 3-4 days. It was some prescription from the doctor, but it was for his wife. He tried it, but it did not do anything. The patient stated the injection itself did not give him any problems. The patient was wondering whether he should take the second shot if this one gave him so much trouble. The clinical outcome of discomfort was unknown. The outcome of the other events was not recovered.

Mouth and face Shingles; still suffering with pain; sore throat; fatigue; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, on 27Jan2021 10:00 at a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]). The patient previously received first dose of BNT162B2 on 06Jan2021 11:00 AM for COVID-19 immunisation (lot number: EH9899, arm left); and cipro and experienced allergies. On 21Feb2021 12:00 PM, the patient experienced mouth and face Shingles and was hospitalized from 28Feb -1Mar (name) Hospital for 1 day. Still suffering with pain, sore throat and fatigue. The events resulted to a doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received included IV#s for 24 hours, brain scan. The facility where the vaccine was administered was in a military Base. 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. COVID test on 28Feb2021 with unknown result. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

Patient presented for second COVID vaccination and had a golf ball sized lump where previous COVID vaccine was administered. Lump was soft and movable.

he had a itching sensation in the palm and fingers on the side that he received the vaccine; This is a spontaneous report from a contactable consumer. A 89-year-old male patient received bnt162b2 (Solution for injection, Lot Number: EL9262), dose 1 intramuscular, administered in Arm Right on 26Jan2021 14:30 (at the age 89-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included gastric cancer from 1989. Concomitant medication included cyanocobalamin (VIT B12) administered in left arm, from unspecified date of 1986 at 1 ml (monthly) for supplementation therapy from 1986 and ongoing. The patient experienced he had a itching sensation in the palm and fingers on the side that he received the vaccine (pruritus) on 26Jan2021. Caller reported that when his father took the shot, he had a itching sensation in the palm and fingers on the side that he received the vaccine. His father received the vaccine in the right arm. He did not touch it, it wouldn't itch, but if he touched it, it would itch. The action taken in response to the event(s) for bnt162b2 was not applicable. Outcome of the event was recovered on 27Jan2021. No follow up attempts are possible.

Rash on right leg - calf region; Aching all over especially where he had the surgical hip revision/ sharp pain; Body pain with continued sharp pain in left leg groin area - site of recent hip replacement; This is a spontaneous report from two contactable consumers (one of them was patient himself). An 89-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318, NDC number: Unknown, Expiration date: Unknown), via an unspecified route of administration in right arm on 09Feb2021 at 10:00 (at the age of 89-year-old) as a single dose for COVID-19 immunisation, second dose of immunoglobulins NOS (IMMUNE GLOBULIN, Formulation: Unknown), intravenously from 01Feb2021 at an unknown dose and frequency for CIDP. Patient received IV Immune Globulin within 2 weeks of vaccination. Recent DX and received 2nd IVIG infusion on 01Feb2021. The patient's medical history included ongoing CIDP (he was diagnosed with CIDP which was chronic inflammatory demyelinating polyneuropathy. The treatment for CIDP was IVIg infusion), hip surgery from 14Dec2020 (he had hip surgery on 14Dec2020. The surgery was at (Hospital name)), Sulfur drugs (allergies to medications, food, or other products: Sulfur drugs, known allergies: Sulfur drugs). Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EJ1686), via an unspecified route of administration in left arm on 19Jan2021 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID- 19. It was reported that, caller calling on behalf of the patient. She was his wife of 63 years. He has a real problem. It was complicated. His birthday was (DOB) and he would be 90 years old this summer. He had hip surgery on 14Dec2020. The surgery was at (Hospital Name). He was diagnosed with CIDP which was chronic inflammatory demyelinating polyneuropathy. The treatment for CIDP was IVIg infusion. He had infusions for five consecutive days on 24Dec, 25Dec, 26Dec, 27Dec, and 28Dec (unspecified year). He wanted to get COVID vaccine. Pfizer does not have a lot of information for people who get IVIg infusions. On 19Jan2021 he got Pfizer's COVID vaccine and had no problems. On 01Feb2021 he had IVIg infusion because he has to wait 28 days between infusions. They had checked with the neurologist and they said a week then they changed it to 10 days. The neurologist said to go ahead because it was nine days. On 09Feb2021 he got second COVID vaccine. That was Tuesday. He was feeling great and walked into the place to get it. He was ok. He woke up yesterday and he was aching all over especially where he had the surgical hip revision on 10Feb2021 at 07:00. It was six inches above the knee to the top of the groin. It was a sharp pain. When he tries to lift his leg to walk it was especially sharp. He was trying to call the surgeon, but he was in surgery all day. The neurologist said to call Pfizer for any information about people who get IVIg infusion and have chronic inflammatory demyelinating polyneuropathy and the COVID vaccine. He walked into (Name) which was where he got it and he felt great. He walked out and came home. He has had no falls or nothing. He just came home. It was like a mystery. There was not a whole lot of information from Pfizer for people that get IVIg infusions except it started with seven days and now wait 10 days. She was trying to research it on the computer and it only says vaccines in general. It says there might be problem with vaccinations with infusions and she has read the literature that pertained to that. The article she read was from three years ago. It may just be a real unusual kind of thing that a person would have IVIg and get the COVID vaccine. She has been on hold for an hour. She has medical power of attorney for her husband. He had no problem with the first one at all. On the vaccine card she could not read the person's handwriting. Waited to do COVID vaccine on 19Jan2021 when he was in skilled nursing facility. He was in the hospital for 18 days and then went to the skilled nursing facility for 12 days. The only thing that was relevant was did the IVIg have an effect with the COVID vaccine because nothing else had changed. That was the only different thing. Morning after - body pain with continued sharp pain in left leg groin area - site of recent hip replacement on 10Feb2021 at 07:00. Morning of 13Feb2021- rash on right leg - calf region. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The action taken with immunoglobulins NOS for the adverse events was unknown. The outcome of the events was not recovered. Follow-up attempts completed. No further information expected.

Mouth and face shingles; This is a spontaneous report from a contactable physician. A 89-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection) intramuscularly in right deltoid on 27Jan2021 as single dose for COVID-19 immunization. Medical history reported was hyperlipidemia, osteoporosis, chronic ischemic cardiovascular disease (CICD III), stroke prevent, all ongoing. Concomitant medications reported was atorvastatin (LIPITOR) for hyperlipidemia, acetylsalicylic acid (ASPIRIN) for stroke prevent, all ongoing and via orally route. Patient previously received first dose of BNT162B2 (lot: EH9899) in right deltoid on 06Jan2021 for covid-19 immunization. The patient experienced mouth and face shingles on 25Feb2021. Patient was hospitalized from 28Feb2021 to 03Mar2021. Treatment was received as tramadol for and Gabapentin for shingles. Outcome of the event was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected.; 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 Herpes zoster cannot be totally excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Incredibly weak; unsteady on feet; 6cm mass on neck; rash on legs; now food all tastes metallic; This is a spontaneous report received from a contactable consumer, the patient. An 89-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown), via an unspecified route in the right arm on 11Feb2021 at 09:00 as a single dose (at the age of 89-years-old) for COVID-19 immunisation. Medical history included benign prostate hypertrophy. The patient had no known allergies. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had been tested for COVID-19 after vaccination. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN) and prostate pill (MANUFACTURER UNKNOWN) for unknown indication and from an unknown date. On 19Feb2021 at 14:00, the patient experienced incredibly weak, was unsteady on feet, had a 6cm mass on neck, rash on legs and food tasted metallic. It was reported that the patient was perfectly healthy prior to vaccine and had a great appetite prior. The events resulted in emergency room visit twice and the patient was treated for these events. On an unknown date, the patient underwent lab tests as treatment for events which included blood work, EKG, chest X-ray, urinalysis, CT scan all with normal results. All the testing done in emergency room had been normal except for mass on neck, it was scheduled to have biopsy of neck on 23Mar2021. The doctors suggested that it was all from the vaccine. The clinical outcome of the events incredibly weak, was unsteady on feet, had a 6cm mass on neck, rash on legs and food tasted metallic was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.