Pfizer

Arm soreness / soreness in the arm and shoulder; Arm soreness / soreness in the arm and shoulder; Emesis; Nausea; This is a spontaneous report from a contactable nurse. This nurse reported different events for 6 patients. This is the sixth of the six reports. A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 at a single does in the left arm for COVID-19 immunization. Medical history included dementia from 10Mar2020 and ongoing. The patient's concomitant medications were not reported. The patient experienced arm soreness (soreness in the arm and shoulder), emesis and nausea on 01Jan2021. The patient received paracetamol (TYLENOL) for the soreness, nothing for the emesis and nausea. The events were all resolved on 01Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.

Mild itching throughout different parts of the body; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3246), via an unspecified route of administration in left arm, on 07Jan2021 11:15 at single dose, for COVID-19 immunization, in a public health facility. Medical history included mitral valve prolapse, glaucoma, and allergy to strawberry. The patient is not pregnant. Concomitant medication included latanoprost; estradiol, norethisterone acetate (MIMVEY); multivitamins; and ergocalciferol (VIT D). The patient did not receive any vaccine within 4 weeks prior to COVID vaccine. The patient experienced mild itching throughout different parts of the body beginning on day 2, 09Jan2021 10:00, and continuing on day 5. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered. No follow up attempts are possible. No further information is expected.

Fatigue, Chills, Low grade fever, Muscle aches. Resident also developed cellulitis to lower portion of arm in which vaccine was administered within 24 hours or less of receiving vaccine and had no previous indication of abnormalities to arm or s/s of infection to arm.

pt. noticed "shingles" outbreak starting after taking the vaccination - pt. uncertain if she should take acyclovir which has proven beneficial in past states physician not giving her confidence regarding take/do not take medication after vaccination due to limited data

Sluggish feeling on 1/16/2021; extreme thirst chills, gassy, loose bowel movement - caramel color . Injection site soreness; today 1/18/21 slight headache - Tylenol dose, headache now subsiding; all other symptoms have resolved.

Lowered body temperature 30 min after dose, left hand began to itch approx. 45 minutes, both hands itching & swelling, then feet within hour. Total lose of vision within 90 min followed by fainting approx 10 minutes later. Fainted at check-in desk of emergency room

A very itchy red hot rash on my right side of my back. Very hot red and lasted about 1 hour. I put Fluocinolone Acetonide topical solution USP 0.01% on my right side from the neck down to bottom of back (only right side).

One day after receiving the vaccine, I developed a deep purple/blue bruise that extends from an inch above the injection site (shoulder of left arm) and extends to my elbow. It is 4 inches wide.

Approximately 1 hour after the shot, I raised a hive on my upper lip. It very quickly (within 2 minutes) got to its maximum size. Not noticeably swollen to an observer, but it felt swollen, red and throbbing. It was not a serious adverse reaction. After about an hour, it was NOT going away, but it was NOT getting worse. I never experienced trouble breathing. The office where I had the shot is "not available" on Friday afternoon, and my personal physician is not in the office on Friday. I was advised by another doctor friend to take benadryl, which I did. While looking at the CDC website, he also advised me that (having had this reaction) I should not receive the second shot.

Four hrs. after getting the vaccine. My face started itching, could feel welts under the skin. Swelling of the right side of my face started within a few hours later. Called Drs. , He recommended taking Tylenol. (Second Day) Next day, felt short of breath, weak, applied ice packs to my face. Third day, felt weak. By the fourth day, swelling and itching subsided; but skin on my face felt gritty under the skin. Drove me to the doctor's office the third day. I was short of breath walking from the car to the door to the doctor's office. I was wearing my mask. I saw a PA; but, she didn't tell me much of anything. I don't think she knew what to say.

Severe chills/tremors.....my entire body was shaking/spasming. It shook my bed and woke me up. Severe sore arm at injection site.

injection site pain/arm hurts tiredness headache slight muscle pain/joint pain ***nausea feeling lousy arm feels like its blown up but doesn't look like it is

RED, BLISTER TOP SORE. USED HYDROCORTISONE WITH NO CHANGE F0R 3 DAYS, NOW NO BLISTER, BUT SKIN STILL RED AND DRY

Late in the day of the shot on 01/21/2021, site on arm began to hurt and got worse in the increasing 2 days. Red very warm rash began at the injection site and spread to the size of a soft ball. Today, 01/25, the site is still red and swollen but not as poinful. Temperature is normal. Along with the affected infection site from 01/21, had a series of fevers ranging from 99.9 - 100.9. Usual body temperature is 97.6. Along with this, severe body aches, fatigue, malaise, deep depression and bed stay for 2 1/2 days. Took Tylenol. Today, 01/25/21 at 11:27AM, temperature is 98.3.

Patient vaccinated at 1215. Reaction began at 1250. Pt was told she would be observed for 30 minutes due to previous history of a reaction to the typhoid vaccine. After 30 minute observation patient stated she was light headed, dizzy, warm, and nauseous. Nausea subsided at 1325. Stated she was still dizzy at 1335 and stated her throat started to feel scratchy and difficult to swallow. Rapid Response called and patient evaluated. Patient transported to ED for further evaluation.

Once the pt sat in the chair she began putting tension on her muscle. I asked the pt several time to relax, I believe she was relaxed at the time of administer the pt again began place tension on the deltoid muscle, after retracting the vaccine needle the site started to swell. I then place a cold compression on the vaccine site and asked the on site physician to assets the site. The patient was place under observation for 20min and she reported feeling better and asked to leave.

Diarrhea; Swollen, very sore, hot arm by injection site; Swollen, very sore, hot arm by injection site; Swollen, very sore, hot arm by injection site; Fever; Very tired; Achy; Headache; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm at 02:00 AM on 10Jan2021 at single dose for COVID-19 immunization. Medical history included thyroid disorder, reflux, elevated blood pressure and elevated cholesterol. Concomitant medication included lamotrigine, buspirone, levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and others. The patient previously took compazine and experienced drug allergy. The patient experienced swollen, very sore, hot arm by injection site. Fever. Very tired. Achy. Headache at 05:00 PM on 10Jan2021. 3-30 hours after injection. Diarrhea (more than 6 times) 44 hours after injection and ongoing on 11Jan2021. 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 treatment for events. The outcome of events was recovering. Information on the Lot/Batch number has been requested.

Patient stated she had a moderate amount of bleeding out the injection site and a small amount of fluid drainage. Client denies any other symptoms and/or signs of infection. Injection site inspected and was clean with no signs of infection /discomfort.

Day 1 moderate to severe pain at site and headache treated with Acetaminophen. Extreme sleepiness for 48 hours and slept for most of the day. 2nd Day pain at site and headache continued. Treated with Acetaminophen. Extreme sleepiness slept for most of the day. Sore throat,cough and nasal congestion and drip, and metallic taste in mouth. Loss of appetite. Loss of hearing and appetite. I woke up at night at 1:00 a.m. with severe nasal discharge and had to sit upright for 2 hours till it abated a little. Day 3 Pain at site continued as did nasal congestion and discharge. Loss of appetite and hearing also continued. I still have nasal congestion and discharge on my 3rd week and also the loss of appetite and hearing loss. The loss of hearing has improved very minutely.

possible "covid arm": 3 inch diameter red spot (rash?) at injection site; mild arm pain down to elbow Rash did not appear until almost week 2 after injection.

1/23/2021 extreme vertigo at 10:00 AM lasting aabout 2 minutes 1/25/2021 at 4:00AM woke out of a sound sleep with strange sensation of spinning. dlosed eyes tights and fell back asleep That morning upon waking at 6:00 AM and getting out of bed, I could not walk and I was extremely dizzy. I made myself get up and all i could do was stumble. Had to hold on to wall. could not put one foot in front of the other. My head felt very heavy like it wasnt attached right..... after Deep breathing and other calming techiques during the day, I was able to walk straight. Tues 1/26/2021 I contacted my Doctor and told him my story. 1/27/2021 I developed a rash across my nose and cheeks which is today.

Rash and severe swelling of the face, Hands and throat. Given intravenous benedryl, Pepcid, Ativan, Prednisone

Hives in random places over body. Started 8 days after original shot. Started with itching. When I would scratch, hives would appear. After 2 days of intense itching, took an antihistamine. This stopped the itching. Took it for two days and itching has not returned.

1. Dry red rash over both legs, torso, chest and back. 2. Elevated liver enzyme values for ALP (289.00), AST (115.00), and ALT (168.0).

Back felt hot, had small red macules. Received 2 doses of Benadryl 25 mg and macules turned to pink color. Left for home.

slight discomfort at the site of injection; occasional soreness at the site of injection; This is a spontaneous report from a contactable physician reporting for herself. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in left arm on 22Dec2020 12:00 at single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medication included atorvastatin, calcium, ibuprofen, estrogens conjugated (PREMARIN), ergocalciferol (VIT D) and multivit (as reported). The patient was not pregnant. For vaccine dose 1, it was reported that the patient experienced slight discomfort at the site of injection and occasional soreness at the site of injection over on 22Dec2020. No treatment was given to the patient for the events. The outcome of the events was recovered on unspecified date. The facility where the most recent COVID-19 vaccine was administered was in the Health Clinic. 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.

Took shot 1/20 and asked the RN if I should take it because I explained I just got over covid, I told her I wasn?t sure how long it was on Dec 19 I was raking leaves and I thought I should do this because I started having runny nose. I didn?t feel well that afternoon sneezing because I thought it was nothing. As the week went on I started sneezing and coughing and stopped up nose. I always end up with sinus infection when I get a cold Dec 28 I went to the doctor at doctors care and they did a covid test before the doctor would see I tested positive. I went home and rested, no energy, felt like I was hit by a train, couldn?t breathe, sneezed a lot and hardly coughed. January 1, I called ambulance and went to hospital, I was sick the first week of January. I didn?t know that you should wait 90 days to get the vaccine after you?ve had Covid. After I got the vaccination the adverse reaction, I woke up during the night with my arm hurting bad and throbbing and a very large red circle appeared on my arm 2? in diameter. The next 3 days I felt like I had covid all over again, the 4th day I woke up and felt a little better and got out of bed and started making progress each day. Now I?m not good, but I?m ok.

A rash on my right arm (got the vaccine in my left arm) from my wrist to elbow. The rash had 3 raised bumps and was swollen. It was not painful but was itchy. It went away in a couple of days. I did not take anything for it but did put Cletrimazole and Betamethasone Dipropionaate cream on it.

Sore arm; mild nausea; mild headache; low grade fever; an odd red mark on my left shoulder about 2 or 3 inches from the injection site; This is a spontaneous report from a contactable consumer (reporting for herself). A non-pregnant 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), via an unspecified route of administration in the left arm on to 14Jan2021 07:15 at a single dose for COVID-19 immunization. Medical history included asthma, chronic obstructive pulmonary disease (COPD), known allergies: animals. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), lorazepam (ATIVAN), biotin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN). The patient previously received a typhoid shot (MANUFACTURER UNKNOWN), for immunization and had very adverse reaction to third typhoid shot. The patient experienced sore arm, mild nausea, mild headache and low-grade fever and an odd red mark on left shoulder about 2 or 3 inches from the injection site on 14Jan2021 21:00. No treatment was received for the events. The outcome of the events was recovering.

Chest tightness; hives on the side of her neck; scratchiness in throat; gums were throbbing; This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EJ1686, Expire Date: 30Mar2021), intramuscular at Deltoid Left on 15Jan2021 11:08 at the 76 years old at 0.3 mL, single for COVID-19 immunization. The patient medical history included allergies issues with shellfish (allergic reactions), hyperlipidemia and hypertension. The concomitant medications were none. There was no additional vaccines administered on same date of the suspect. The patient was experienced for over 20 minutes with no side effects. After she left on an hour after administration (15Jan2021 12:08), she started feeling scratchiness in throat, her gums were throbbing and chest tightness. She did say she didn't take any Benadryl. She didn't have airway issues, but she did have hives on the side of her neck on 15Jan2021 12:08. She got the shot on 15Jan2021. The side effects started shortly after she left on an hour after administration. Her symptoms were relieved by 15Jan2021 21:30, and she got the shot at 11:08 am. The patient had allergic reactions in the past. She knew what to expect. She got the shot in her Left Deltoid. The reporter had a gut feeling she didn't need to get the second dose. The reporter assessed all the events were not serious. She did not require medical intervention. She did not go to the Emergency room or Physician Office. The patient was not hospitalized, or in the ICU. The Causality was not provided by the reporter. The outcome of the events was recovered on 15Jan2021 21:30.

had a little pain in her arm/ little pain in her arm where they gave the shot; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), intramuscular on 18Jan2021 (unspecified time, 13:15 or 13:30) at single dose on left arm for COVID-19 immunization (prevent COVID). Medical history included none. There were no concomitant medications. The patient experienced had a little pain in her arm/ little pain in her arm where they gave the shot on 18Jan2021. She received her first shot today and is "set up" for the second. She waited for 15 minutes after receiving vaccine and left the facility at 13:50. She had a little pain in her arm where they gave the shot and the patient asked if the pain gets worse can she take Ibuprofen? Her doctor told her she could take Ibuprofen everyday if she has pain, but she just wasn't sure if it was ok after the vaccine. Her left arm pain is not bad right now, she is more concerned if she can take ibuprofen if it gets worse. She does not take medicine just because. The outcome of the event was unknown. The event was assessed as non-serious. No additional vaccines administered on same date of the Pfizer. No AEs required a visit to emergency room or physician office. No prior vaccinations (within 4 weeks). No AEs following prior vaccinations.

red swollen arm at injection site; red swollen arm at injection site; red swollen arm at injection site, became itchy lasted 1 week.; elevated temperature; body weakness; severe headache for 3 days; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3246), via an unspecified route of administration at site of left arm at 11:00 on 09Jan2021 at single dose for covid-19 immunization. Medical history included lung cancer, chronic obstructive pulmonary disease (COPD), atrial Fib, hypertension and COVID. The patient's concomitant medications were not reported. The patient experienced red swollen arm at injection site, became itchy lasted 1 week. elevated temperature, body weakness, severe headache for 3 days, all occurred at 05:00 on 10Jan2021. Facility type vaccine was Doctor's office/urgent care. No other vaccine received in four weeks. Other medications received in two weeks. Adverse reactions did not result any serious consequences. No treatment received for adverse event. No COVID tested post vaccination. No known allergies. The outcome of events was recovered in Jan2021.

Reaction on dorsal side of right wrist: what appeared to be tiny red pin pricks over an area of about 1.5?x2? was observed at night of injection date. I applied Hydrocortisone cream USP, 2.5% to area and bandaged that night, and the next morning it appeared to be a rash. Reapplied ointment and rebandaged after shower every morning since then, through today 2/3/2021 It appears to be itching her and causing her to scratch until ointment is applied. No improvement so far.

I received this shot on Jan 30 and have been sick ever since. I Threw up for several days and and still sick to the stomach. I had severe diarrhea and my bowels are still messed up- they are light yellow verging on white. I have been having migraines and am very weak and shaky. Pain at injection site is trivial. Pain through out my body is not. I am often dizzy.

Within 15-minutes of vaccination, the patient reported arm soreness and pain at the injection site. EMS monitored patient's condition on-site.

Approximately 2/3rds of the arm has swollen up/ mild swelling; her arm is still red, this happened after the second dose/ it was very red and warm and itching/ it was a red area about 5 cm in diameter around the injection site in the upper arm; it was very red and warm and itching; Soreness of the arm/It hurt, it was warm, slightly swollen and raised from rest of the skin; It hurt, it was warm, slightly swollen and raised from rest of the skin. It was initially located in like the back of the arm, right where the shot was given; It hurt, it was warm, slightly swollen and raised from rest of the skin. It was initially located in like the back of the arm, right where the shot was given; This is a spontaneous report from a contactable Physician. A 76 year old female Physician reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK4176 Expiry date 31Mar2021), at single dose in the left Arm on 14Jan2021 at 2:30PM for COVID-19 immunization. The patient had received the first dose of BNT162B2 (lot E11865, Exp Mar2023) in the left arm on 23Dec2020 . Medical history included asthma and allergy. She had a contrast IV reaction before. She is Allergic to everything, inhalants, weeds, dust, trees, grasses, foods like chickpeas that have her bad asthma and fishes like Halibut. When she did a skin test she reacts to everything. She has been on prednisone. She was admitted to the hospital a year ago in November for an asthma attack. Concomitant drugs included inhalant steroid medication and other medication for Asthma. The patient reported that on 15Jan2021 after the second dose, approximately 2/3rds of the arm has swollen up, this lasted about 7 days. On the 8th day and it is beginning to go down. She also added that her arm was still red. The mild swelling actually started as itching, within 10-12 hours, when she woke up and looked it was a red area about 5 cm in diameter around the injection site in the upper arm. It hurt, it was warm, slightly swollen and raised from rest of the skin. It was initially located in like the back of the arm, right where the shot was given, like upper back of arm. On 16Jan2021, it was close to half of the upper arm, well not exactly half the arm, but it was very red and warm and itching, on the left Arm. On 17Jan2021 it was at 2/3rd of the arm, almost 15 cm's in length at that point. Still very red, it wrapped towards the front of the arm, she could see the color without looking in the mirror. The swelling has ended, the raise part stopped around the 19Jan2021. The redness as of the 19Jan2021, it was less, the skin is slight pink, pinker than the normal skin, she has put some steroid cream skin lotion on the red area, she did that on 16Jan2021 twice a day. She also took Benadryl for 2 nights on 16Jan2021 and 17Jan2021. The itching stopped, when the skin was covered it was not that bad, but when the air hits it, it itches. Caller also added that there was soreness on the arm, it was achy, but it was very minimal now, she notices it when lifting things, that was when it hurts.

Reaction 1: sore left shoulder at the injection site next day for one day only Reaction 2: 5 days after vaccine, noticed blood on my shirt where I had been itching, left upper arm between injection site and elbow. Appearance of skin is rash, welted, red, bruised and sensitive to touch in an area about 3x3 inches. OTC anti itch cream not effective. Itching became so severe, I went to my dermatologist 3 days after itching started. Diagnosed as Allergic Contact Dermatitis due to Covid 19 vaccine. Given Rx anti itch cream and told to use cold pack when it was itchy and take OTC antihistamine. Followed doctor's orders and itching finally stopped after 12 days from onset.

Site uncomfortable for week plus one day. Then hard pain in shoulder and spreading across shoulder, up neck and down around collar bone. Went to Dr. and was told it was neuropathy and was prescibed Prednisone.

Rapid heartbeat, shaky, clammy skin, heavy perspiration, nausea, stomach cramps, pain throughout body along with pin and needle feeling mostly on the left side from my foot to the top on my head. Lips felt swollen. Itch in chest, neck with a rash, back legs, mostly all over.

headache; she had a mild soreness in her left arm after getting the COVID-19 Vaccine; This is a spontaneous report from a contactable pharmacist (patient) via a Pfizer-sponsored program Pfizer First Connect. This pharmacist reported similar events for two patients. This is the first of two reports. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1283) via an unspecified route of administration on 19Jan2021 10:30 AM at single dose on left arm for COVID-19 immunization. Medical history included temporomandibular joint (TMJ) pain in jaw and headache. Concomitant medication included Tylenol for temporomandibular joint (TMJ) pain in her jaw. The patient (retired pharmacist) stated that she and her husband got the COVID shot on Tuesday (19Jan2021) and prior to getting the vaccine, she was suffering temporomandibular joint (TMJ) pain in her jaw and took Tylenol that morning. Patient just came back from urgent care and was prescribed a dose pack of prednisone to take for 5 days for the TMJ and she is concerned about taking it because she knows it can suppress the immune system and she does not want to make the vaccine less effective. She was trying to figure out if she should just tough it out and not take the steroid. She and her husband, who was on warfarin, had a mild headache after the first shot but he has sinus issues and she had the TMJ, they were not sure if the headaches were from those things or the vaccine. Patient asked if she can take Tylenol since she found out that that may not have been a good idea. She was advised to take Prednisone and she was asking if she can take it or will it affect the efficacy of the vaccine. She stated not knowing that taking Tylenol can effect the efficacy of the COVID-19 Vaccine, she had taken Tylenol before she received her COVID-19 Vaccine on 19Jan2021 (Tuesday). Patient said her TMJ jaw pain was still a problem after she received her COVID-19 Vaccine, so she had gone to her doctor, and her doctor prescribed Prednisone, a corticosteroid. She said she was not going to take the Prednisone because she does not want the Prednisone to cause an issue with the efficacy of the COVID-19 Vaccine. Patient said she then read that studies performed on children said that children that took Tylenol did not get as good of an immune response from the COVID-19 Vaccine. Patient said since she already took a dose of Tylenol for her TMJ jaw pain before receiving her first COVID-19 Vaccine dose, she was afraid to take any further Tylenol. Patient clarified that the Tylenol she took was the generic Equate brand, 500mg. She said she took 2 Equate brand generic Tylenol 500mg for jaw pain on Tuesday morning (19Jan2021) prior to getting her first COVID-19 Vaccine. She said she had disposed of Equate brand generic Tylenol bottle and cannot provide the UPC, Lot and Expiration Date. Reported that both her and her husband did have a headache all day long after receiving the COVID-19 Vaccine. She said her husband believes his headache was from the COVID-19 Vaccine. She said she was not sure if her headache was from the COVID-19 Vaccine or from her TMJ jaw pain. She said when she has TMJ jaw pain, she usually has a headache accompanying the TMJ jaw pain. Also reported that she always gets her vaccines in her left arm. Patient was surprised she and her husband did not have anything more than a headache after receiving the COVID-19 Vaccine. She said when she had the Shingles Vaccine, she could not lay on her left side for a week because her arm was so sore for 2 days, and when she had the flu shot she could not get out of bed for a day. Patient clarified she got her first dose of the Shingrix Shingles Vaccine in Nov2020, and does not plan to go and get her second Shingrix dose until the summer of 2021. Patient stated that she does not want the second dose of the Shingrix Vaccine interfering with the COVID-19 Vaccine. The patient had headache on 19Jan2021, reported as mild. Patient also had a mild soreness in her left arm after getting the COVID-19 Vaccine on 19Jan2021, and the left arm soreness was gone in less than 24 hours. Patient further clarified that she had a headache before getting the COVID-19 Vaccine. She said her TMJ jaw pain acts up if she eats. She said when she has TMJ jaw pain, she gets an excruciating headache. She said she has no headache pain at all right no. Patient expected to have kind of a worse reaction to the COVID-19 Vaccine based on what other people have been saying. The events were assessed as non-serious. Outcome of the event headache and mild soreness in her left arm was recovered in Jan2021. Patient does not think her headache pain was related to the COVID-19 Vaccine.; Sender's Comments: Based on the time association and drug's safety profile, the possible contribution of suspect vaccine BNT162B2 to the event headache cannot be totally excluded. The underlying temporomandibular joint and headache may be cofounders.,Linked Report(s) : US-PFIZER INC-2021082288 same drug/reporter, similar events, different patient

Chills, fever, muscle aches, weakness, fatigue, nausea lasted 24 hours, then fatigued for another 12 hours. Recovered completely within 36 hours. Arm red, sore and swollen for 36 hours

flu like symptoms--aches, chills, headache, fatigue, followed by red rash over left chest area, with itching Treated with benadryl with little effect. Received Rx for dosepack Prednisone. Also applied cortizone OTC to rash area. Flu like symptoms abated wtihin 36 hours; rash improving more slowly.

When the nurse gave me the first dose, she said "your arm is so small I thought I might of hit your bone". When I got home and took the Band-Aid off there was a small red mark, which went away by the next morning. Then next day after that I started having extreme pain and numbness in my left arm. The pain is from my shoulder, to my fingertips, and under my arm. It is still hurting today. I have been taking Advil, putting pain cream on it. It is still hurting as of now.

BP;A bit high for her; Anaphylactic reaction; back rash; burning sensation; swollen face; itchy back; Back getting hot; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 76-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date not reported) , via an unspecified route of administration on the left arm on 27Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included anaphylaxis with contrast media (Biaxin and eucalyptus), allergies: latex, antihistamines, sulfa, olive trees; allergic reactions to iodine, asthma, cardiac arrest, has a pacemaker; all from unknown dates. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), vitamin D3, levocabastine hydrochloride (ZYRTEC), iron, diltiazem, salbutamol sulfate (ALBUTEROL). The patient previously took Biaxin, eucalyptus and tiger balm and experienced anaphylaxis, Cipro, sucralfate, adrenaline (EPIPEN), corticosteroid and experienced allergies. The patient previously received Shingles vaccine on Nov2020 for immunization and experienced intermittent itchy back sensation. The patient reported that after vaccine reaction today (27Jan2021) - back rash, burning sensation, swollen face. It was further reported that the patient experienced potential anaphylactic reaction; 15 minutes after the administration she got her back getting hot and Itchy and a rash breakout. It was also reported that the patient's BP was a bit high for her on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: a bit high for her on an unspecified date. Therapeutic measures were taken as a result of anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot which included treatment with Benadryl (Took one 25 mg Benadryl. Then she took another 25 mg Benadryl); it was reported that 30 minutes later symptoms started to subside. The patient recovered from anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot on 27Jan2021, while the outcome of BP was a bit high for her was unknown.

Client received Pfizer covid vaccine, and during her observed wait time, she became hot and felt a flush through her body. She also reported tingling in her tongue and throat. She reported itching of her chest, cheeks, and ears. Client was brought back to emergency area, and was assess by nurses. Client did have a prior history of allergy to Iodine and shellfish- but never anaphylaxis. 10:20am, pulse 68, bp 142/83, 98% O2. 10:25am, bp 140/85, still complaining of throat swelling and itching, pulse ox stil 98%. Once client was in a private area, she reported that the flushing and feeling of being hot, had gotten much better. Per Client , her tongue and throat, were not getting worse. Our Medical Director was contacted, and the decision was made to give Benadryl IM. 10:39 pulse 70, O2 95%, . 10:41 am 1ml (50 mg) Benadryl given IM in the right deltoid (lot # 080014, exp. 8/2022). Within a few minutes patient reported that signs and symptoms were better but had not completely gone away. 10:44, respirations 14/minute, O2 94%, patient sat up at this time to help clear some phlem. 10:46 client states tongue feels better. 10:53 am 96% O2, pulse 93. Nurses continued to monitor client, and asked if she felt any worsening of her symptoms to warrant more medication. Client stated she felt a little better and would like to go home. 11:15 am, spoke to Docter again, per his instruction, client was allowed to go home with her sister. Instructed to take more Benadryl in 4 hours if symptoms return. Client was told if anything gets worse than her original symptoms, regarding her airway, tongue, lips, swallowing, she should call 911.

a rash on her chest/have a rash on her chest that itches; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EK9231; expiration date: unknown), via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. Medical history included blood pressure (blood pressure abnormal), borderline diabetes, hypertension, arrhythmia and cholesterol high. Concomitant medication included amlodipine besilate for blood pressure, metoprolol succinate (METOPROLOL SUCCER) for arrhythmia, metformin hcl and rosuvastatin calcium for cholesterol high. The patient reported that she received the first dose of the Pfizer vaccine on 22Jan2021 and two days later she noticed a rash on her chest. She mentioned that she has been using an anti-itch cream. She mentioned that she was supposed to schedule her second dose for 12Feb2021 but is unable access the website to schedule her appointment through. She mentioned that she had a rash on her chest that itches, and she have got some itching cream, but she keeps waiting for it to finally go away but so far it is still there. When asked about the treatment, she mentioned that she had Triamcinolone 0.1% for other usages from her skin doctor (her dermatologist). The outcome of the event was not recovered.

2/3/21 vaccine given rt. arm; 2/11/21 very hot bright red 3 inch diameter extremely itchy; 2/12/21 at 0300 injection site is raised up like blister 3 inch diameter; red is less than night before; at 0800 2/12 still swollen injection site; 1800 2/12/21 swelling is going down; but you can still see outline of 3 inch diameter; some itching; more muscle pain in area. Doctor did video with me at 1830 and he said it was delayed allergic reaction and to contact you. pictures taken of site at this time. will send if you wish. wonder if I should have second dose.

I had my shot in my left arm Last night (02/12/2021) I noticed a slight irritation and itching on my right forearm. Today (02/13/2021) I started rubbing and scratching on my right forearm as it increased in irritation and itching. I looked at it and there is a long rash on it. As I type the top of my left hand is starting to itch and top of right hand as well but no definitive visible rash.

One week after the first vaccine, I had severe pain in my right arm. I could barely lift it. applied ice and pain lessened...Then other events followed...My left wrist became swollen and red. then a day later the severe pain was in my left arm and I could barely lift it. I then had a swollen right foot. Podiatrist gave me a shot of cortisone but continued to have the pain and swelling...Shoulder pain returned. 2nd vaccine was 02/03/2021...Feb 10...both hands were stiff and I couldn?t open them...Then the shoulder pain in my right arm returned . This lasted 4 days...with the most severe pain.

RIGHT FOOT RASH; REPORTED 1 WEEK AFTER INITIAL VISIT; ALERTED PHARMACY WHEN SHE CAME IN FOR THE 2ND DOSE ON 2-16-21.

Injection was painful - arm numb and tingled to fingers. 10:45b/p 116/62 pulse68 respirations 16 Normal movement,color and temperature in fingers. Capillary refill <3 seconds. Client refused further medical treatment.

UNKNOWN VACCINE BRAND; Subjective swelling of throat, swollen lips, diffuse eythematous rash on trunk and extremities, anxiety; received famotidine, NS, ativan, diphenhydramine, solumedrol

Patient developed brown spots above upper lip that appeared to crust over and itch; also developed these right below lower lip; these are getting better as of 2/19/21 but are still there; patient contacted doctor on 2/18/21 re this

extreme sharp pain in vagina, intermittent - lasted about half an hour or more; no treatment; resolved and didn't return. hives: neck, chest, redness in armpits, and at temples/hairline; (appeared 48 hours after vaccine, 6 am on 2/18; worsened by morning of 2/19; gone by morning of 2/20. Treated with over-the-counter hydrocortisone topical cream.

Developed shingles, given salves,valacyclovir, 1gm for 7 days, pain patches, gabapentin. Had very achy joints and very sore arm that was injection sight, which is still tender and still sore today and still suffering from shingles. Shingles rash appeared 6 days after shot. Sore arm began 11 hours after shot.

I received my 2nd vaccine at 12:15 at the facility on Tuesday, Feb. 16. At about 10:30 that night I began to feel a bit light headed. I went to bed around 11:30 and didn't sleep very well. On Wed. am after going to the bathroom, I felt woozy while washing my hands. When I thought I felt better, I made my way back to the bedroom and passed out. I fell on my right side, bruising the right side of my face, my right hip and my right thigh. I apparently had my left hand under me when I fell because I broke the knuckle under the pinkie of my left hand.

Immediate itch in the head and arm fifteen minutes after shot along with slight swelling of the lip. Then 2 weeks after 2nd dose the same itch has returned all over the body along with some open rashes on the skin.

After receiving her vaccine client stated that she has stiffness and redness in the right arm in which she had her vaccine was given. Vital signs obtained by EMS BP 115/73, HR=74, o@ sat 96%. Client states she feels better. Client declined to be transported to the ER. Discharged home by EMS.

On second day after second dose (2/22/21) lump on arm below injection site, and enlarged lymph node on left side of neck.

I started noticing small blisters on my right lower leg on shin area that were very itchy. Day by day I noticed an incease of clusters of blisters forming below the first site. They then circled from front to back halfway up my lower leg. Large whelpy itchy places continued to form on my upper forearms and back of right arm elbow. Then the same effects started on my left leg on the back side between my knee and ankle. I have now a large circular area on my lower back at the waistline with solid itchy hard bumps that has increased in size and discomfort. I have red itchy blisters on both my left and right uper wrists. I am noticing small clrcular bumps on my right and left forehead.

Three days after the Covid-19 vaccine injection, left arm became reddened, warm to the touch, painfully tender, lumpy under the skin, over an irregular area approximately 4x5 inches. Doctor diagnosed infection as cellulitis, and prescribed doxycycline 100mg for 5 days. Because of the underlying primary immune deficiency, this will be a difficult adverse event to overcome. First noticed on February 25, 2021. Covid-19 vaccine was administered on Monday February 22nd 2021.

4 days after 2nd dose: hives all over my body and swelling of face and eyes. Called Telemedicine at Urgent Care Huntsville Hospital. Was given instructions to take 40 mg of Prednisone first day and taper off, 2-3 doses of antihistamine and Hydrocortisone on welts. Needed to go to ER for IV if face swelling did not go down. Today (second day after call): Face swelling is down but hives are possibly worse (large welts over large portion of body plus on hands and feet and chin)

Noticed large red spot (approx. 2" X 3" at Injection site on right arm today, 02-27-2021. Some soreness still at the injection site. Have never had any reactions like this before when have taken Immunizations shots.

Within an hour, I felt like I had been hit by a tank; difficulty breathing, dysequilibrium, problems with balance that induced dizziness and vertigo, wobbly gait, extreme weakness, continual tiredness--not refreshed by sleep, difficulty sleeping, insomnia, injection site pain, severe headaches for weeks, eyeball pain, chills, fever, inflammation, joint pain, muscle pain, activity-induced or cognitive exertion muscle fatigue, nausea, swollen lymph nodes, especially in neck, sore throat, difficulty swallowing, cognitive problems -- difficulty with memory, focus, concentration, problems with wordfinding ability, misspeaking; short-term blurry vision; extreme difficulty with body temperature control leading to shaking

broke out in bumps all over the body and was given Fluocinonide ointment for topical use back to the doctor on March 8,2021

Patient began feeling tired 1 hour post dose. At 3 hours post dose, patient began feeling woozy, dizzy and disoriented. Patient got dizzy and passed out while walking to bathroom. She fell and sustained a significant laceration to her arm. She continued to feel dizzy and "just not right" several times over the hour until she finally called 911. When paramedics arrived, she continued to lose consciousness and required full assistance to be placed onto the stretcher. Her BP was all over the place for the better part of 6 hours, with highs as high as 145/95 and lows as low as 81/42. This reaction lasted for a total of 8 hours.

Aprox 10 minutes after receiving the vaccine client started c/o stinging and tingling in her hands and they were red, she felt flushed. No medications given. She felt better shortly afterwards. She did not let her PCP know of this information.

Woke up Sunday morning with my face swollen and fire red on the right cheek and rash on the left cheek and brow. Right cheek hurts because of the swelling. Took 2 Benadryl at noon. Right cheek is burning. Today is Monday and it is still swollen but not as red. It hurts and got more Benadryl to take. Took 2 at 3pm today.

Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262; Expiration date was not reported) on 03Feb2021 (12:15) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the physician's office. Medical history included vulvodynia; back issues; sulfa allergy; penicillin (PCN) allergy; and allergy to "mycins". Concomitant medication included estrogens conjugated (PREMARIN) and propranolol. The patient previously took morphine sulfate, and had drug allergy; lansoprazole (ZOLANAS), and had drug allergy; and tetanus vaccine, and had allergy to the vaccine. The patient was not pregnant at the time of vaccination. On 11Feb2021 (16:30), the patient had induration/3-inch diameter raised injection site that was hot, very red, itchy and hard around it. The reported events resulted into physician's office visit. The patient did not receive any treatment for the reported events. The outcome of the events, 'induration/3-inch diameter raised injection site that was hot, very red, itchy and hard around it', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.

sore throat; Tenderness of the Right Arm; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EH9899), via an unspecified route of administration on the right arm, at age 76 years first dose on 22Jan2021 at single dose for COVID-19 vaccination. Medical history was none. There were no concomitant medications. Patient had the vaccine first dose on Friday (22Jan2021), she had tenderness in the arm at the site but nothing major. Then this morning (27Jan2021) she had a really bad sore throat, it's really sore. She asks if this is a side effect. She asks can she take aspirin or Tylenol. Reporter Type: She has worked in a doctors office in the past but it was just doing medical records. She confirms that on 22Jan2021 was her first dose of the covid vaccine, the tenderness of the arm was on the same day, it happens anytime she gets a shot, the Sore Throat started this morning. Primary care: Declined, she has only been going through the vaccine program. The tenderness of the right arm, is barely there, its like nothing there, its just a little. For the Sore Throat , she drank from tea and had a lozenge and so its not as but is still there but not terrible. Patient stated that she just want to know if she can take aspirin or Tylenol Covid Vaccine Card: The Expiry is not written on the card. Date of second dose: 12Feb2021 Concomitant Medications; No She was just sleeping and woke up with it. The outcome of the event sore throat was not recovered, while for the other event, it was recovering.

Arm swollen and turned red 3 inches above and below injection site; Arm swollen and turned red 3 inches above and below injection site; arm swollen and turned red 3 inches above and below injection site. She said it does not hurt, but just feels kind of heavy; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (lot number: EN5318), intramuscular on 25Jan2021 08:30 at single dose in the right arm for Prevention. Medical history included diabetes diagnosed 10 years ago, acid reflux and cholesterol, all on unknown dates. Concomitant medication included esomeprazole sodium (NEXIUM) taking for 10 years for Acid Reflux, ongoing metformin for diabetes, "Sarxigo" taking for about 3 years for diabetes and unspecified cholesterol medication. On 26Jan2021 09:30, the patient experienced arm swollen and turned red 3 inches above and below injection site. She said it does not hurt, but just feels kind of heavy. The flu shot did that to her too, but not as bad. Flu shot turned her arm red this year also. She got it in Oct2020. She also got in the right arm in the muscle. She would like to know if she will she be safe to take second dose of BNT162B2. The patient did not receive any other vaccines within four weeks prior to the vaccination. The outcome of the events was not recovered.

more tired; left arm/injection arm, had a little bit of pain; little more drowsy than normal; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: PFREL1283; expiry date: 30Apr2021) via an unspecified route of administration on 08Jan2021, at single dose, for COVID-19 immunization. Medical history included pre-diabetic, thyroid disorder and cholesterol abnormal. Concomitant medications included levothyroxine for couple of years for thyroid disorder and rosuvastatin for 30 some odd years for blood cholesterol abnormal. The patient reported that with the first shot, she had side effects she was aware of. On 08Jan2021, she was a little more drowsy than normal. It was nothing severe, but when she was up and awake, she could tell she was more tired. That lasted over 3 days. It wasn't like she couldn't do anything. She just felt more tired than normal. It was different than normal. On 09Jan2021, her left arm, which was her injection arm, had a little bit of pain. She understood that though. It lasted a couple of days. Outcome of the event tired was unknown, while for the other events was recovered on 10Jan2021.

Swollen Lympf Nodes(7 days), slight headache(two weeks) tiredness(1 week)muscle aches(1 week),severe itching on back (no rash(2 weeks)nausea(1 day) Tylenol for headache, rest for tiredness, caladryl, Zyrtec, Pepcid for severe itchiness, Dr visit on Feb.22 - had me take a flu/covid test came back negative.

Patient developed a 2.5 cm hematoma and stated it was itchy. Inspection and light palpation showed lump under skin with redness, no rash.

pustules across her back; In her throat she is getting hoarse; itching with the rash; rash that is all over her body; splotches on her belly on her right side, right below her waist /Two splotches on right hand side; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249), via an unspecified route of administration at left upper arm on 26Jan2021 at 14:19 at SINGLE DOSE for COVID-19 immunisation. The patient had no previous immunizations. The patient had no prior vaccinations within 4 weeks and no additional vaccines administered on the same date. Medical history included allergic to penicillin, bladder infection, in the middle of her chest she had the pain cling through her back, and thyroid getting lazy and does not work. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), levothyroxine sodium (SYNTHROID) for thyroid getting lazy and does not work, vitamins, and sulfa drugs for bladder infection. It was reported that after getting the first dose of the vaccine the patient noticed she had pustules across her back on an unspecified date. The patient stated she "got this rash from the tips of fingers, even the palm of my hands and it starts right under the neck and goes across my breast, on my belly, on my back and both arms and is now halfway down my shin bone." On an unspecified date in Jan2021, she noticed this the afternoon of her vaccine around 7:00 when she saw two splotches on her stomach and it kept spreading. Sunday morning she went to Quick Care and yesterday went to her regular doctor. Her doctor gave her prednisone to take 10 mg 4 times a day, and hydroxyzine 10 mg for itching. In her throat she was getting hoarse on an unspecified date and was keeping a water bottle on her desk to keep hydrated. She stated she read on (website) that a rash can be a symptom of the vaccine. The caller asked, "if the pustules burst will this cause anyone to get Covid 19? Is this a possible side effect of the vaccine? How long will this last? Is it okay to get my second shot with this reaction? Is there anything I should be taking to make it go away?" It was further reported that patient received paperwork to call if there was any type of reaction. The patient mentioned she has a rash that was all over her body on 28Jan2021. It was on the top of her hands, in the palm of her hands, on her arms, back, under her breast, on her chest, on her stomach, on her bottom end, it was going down her legs and to her knees at this point. The patient initially stated she noticed the rash on Friday (29Jan2021), she later stated it was Thursday 28Jan2021 when the rash first started. She stated she first noticed splotches on her belly on her right side, right below her waist on an unspecified date in Jan2021. At first when looking at it she did not think too much about it. Later in the call she further clarified and stated it was possible she noticed these splotches the same day in the evening on the day she got the vaccine. She was not sure. If it was not the same day it was the next day. Friday (29Jan2021), she started to get as initially stated bumps, but later clarified rash under skin and it really proceeded from there. Additionally, it was reported that the rash continued to spread throughout her whole body. It was down to her shin now. Her whole upper body was horrible. She has some across her back. There are pustules on them like a pimple. It was like water in it ready to break. Sunday she went to a (clinic name) to get it looked at. She went Sunday 31Jan2021. She was given an intravenous (IV) and three needles were placed in it. She knows one was a steroid, she does not know what the other two were for, but she thinks one was probably for itching. The patient also confirmed she also experienced itching with the rash on 28Jan2021. It started the same day she noticed the rash. The patient stated it was like a full blown case now. The itching was with the rash on 28Jan2021. The itching and rash has continued to go down her body. It was on her buttocks now. It was hard to sit. It was in private up between her legs and stuff. Her body was almost 80 % full and covered with this stuff. She saw her regular doctor yesterday. The doctor at (clinic name) thought this reaction may have been an allergic reaction to a Sulfa drug she was taking for a bladder infection coincidentally at the same time, but she does not believe this was the case. Stated she had taken that sulfa drug before previously. She does not have the name of the drug to provide of the sulfa drug. She does not have it with her. No blood work was done. She was just looked at. They saw what was going on. The patient also mentioned she went on the internet to do research. She saw on Pfizer page three pictures that resembled what she had going on. It was also reported that the two splotches on right hand side started about 7'clock in the evening. At first did not think anything of it. Thought it was possibly a bug bite at first. Additionally, it was reported that patient went to see a doctor. She was already going to the doctor for a bone density scan and she showed the doctor what was going on at the same time. Her primary doctor thought this was due to the COVID 19 Vaccine. At end of call, patient questioned "if the pustules across upper back and behind neck, will that cause anyone to get COVID 19? Side effect?" The patient had no emergency visit. Therapeutic measures were taken as a result of itching with the rash, rash that is all over her body, and two splotches on right hand side. The patient had not yet recovered from rash that is all over her body while outcome of the events pustules, itching with the rash, in her throat she is getting hoarse, and "splotches on her belly on her right side, right below her waist /Two splotches on right hand side" was unknown.

Within 8 hours of the vaccine, I experienced severe muscle weakness (could not lift arms above head; could not stand from sitting position without pain). During night, could not turn over in bed without pain. This lasted for 3-4 days. Treated with Advil. Next symptoms were joint pains and stiffness and back pains, which also lasted about a week. Treated with Aleve and hot/cold compresses. Final symptoms are severe swelling and stiffness of hands and fingers, with cracked, peeling skin. I have had this for about a week now and it is not improving. Cannot grasp anything with either hand. Middle and index fingers on both hands useless.

Experienced right side aside pain 3 days after vaccination and broke out with shingles rash 6 days after vaccination

At the time of the injection a small red area was identified. There was mild pain in my arm for a day or two. Six days later the red area has became about four times larger and spread around. Pain is still mild- the upper arm is sore and itchy.

She received the second Pfizer-BioNTech vaccine in the right shoulder on 3/6/21. That afternoon she develops severe itching all over her body. The itching is still occurring as of 3/9/21. Treatments thus far have been topical otc steroids and benadryl cream, and today she received 4mg IM decadron. Outcome is still to be determined.

Lost consciousness; palms began to itch, then soles of feet; This is a spontaneous report from a consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (lot number was EL8982 and expiration date was unknown) via an unspecified route of administration at left arm 18Jan2021 14:30 at single dose for COVID-19 immunisation, amoxicillin via an unspecified route of administration from 18Jan2021 at 14:50 at 4 DF for dental apt, procaine hydrochloride (NOVOCAIN) via an unspecified route of administration from 18Jan2021 at unknown dosing regimen for an unspecified indication. Medical history included 3 joint replacements and known allergies to raw celery, clover honey and ragweed. Concomitant medication included atorvastatin calcium (ATORVASTIN), brimonidine tartrate, timolol maleate (COMBIGAN), levothyroxine, tolterodine. There was no other vaccine in four weeks. Patient did not have COVID prior vaccination. The patient had no reaction in first 15 minutes. Within 20 minutes of shot, patient took 4 amoxicillin for dental apt (as reported), then received procaine hydrochloride (Novocain). 45 min after shot, her palms began to itch, then soles of feet. Then she total loss of sight on 18Jan2021 at 15:30. Patient lost consciousness at emergency room check-in. Patient visited emergency room/department or urgent care. Patient received epinephrine injection as treatment. She also had CT scan of head and chest in Jan2021. She did not have COVID tested post vaccination. The outcome of events was recovered in 2021. The action taken in response to the events for amoxicillin and procaine hydrochloride was unknown.

I developed arm pain, up my arm to my neck, Then 2 days later developed a rash on my wrist, arm and top of my back.

Day of shot at 5:00 pm my palms on both hands had itching and I had to keep scratching them. It was driving me nuts. Later that evening my feet were also itching. All night long and into Tuesday but the itching also included my underarms, chest, and upper thighs. Finally on Tuesday I started taking 2 Benedryl tablets every 6 hours, however at 4 hours the itching came back but seemed to be only on the upper body. It is now a little over 72 hours since my shot and I'm still suffering the itching, but not quite as bad with Benedryl. Since I didn't see this on the list of possible side effects, I thought you should know.

Rash in mouth and throat and shortness of breath on Thursday 3/11/21 around 7 p.m.. Called Covid line and spoke to a RN who recommended that I take Ibuprofen and not to take an antihistamine, and to contact my doctor in the morning. Also to go to the ER if symptoms got worse I took Ibuprofen every 4 hours over night and called my primary care physician in the morning. He sent me to the Urgent Care center since the rash had persisted . The Urgent Care physician prescribed Prednisone and Benadryl. I am taking antihistamines and Ibuprofen for relief of rash and itching. I will follow-up doctor on Monday.

Terrible nightmare during night of injection. Smothering and paralyzed feeling. Shouting out in my sleep. Husband finally woke me . When I got up to take a Motrin I was disorientated. Did not know where I was. . Next day experienced several sudden feelings a syncopye. Lasting a few seconds. Had to grab on to something due to a feeling that I was going to fall. It lasted just a quick second or two. Happened several times that day. Like what I would think a TIA would feel like. Arm was just slightly tender and stinging the first day,. In the night it was aching and hot up into my neck. The next morning it was fine again. Just tender and a little stiff. I attempted to report this on line at instructed on forms given me when I left the site. however the CODE that was to be sent to my phone never came. I then entered the wed site and attempted to report it there. . Finally I called my primary Dr and he has instructed me to report this to the person giving the second injection. I doubt they will know what to do seeing as they are volunteers with little experienc.e

Initial nausea, aches and chills and very sore arm. Two days following shot allergic reaction in the form of hives and itching on lower extremities and slightly on lower side of upper arms. (No adverse reaction to first shot)

Rash; Fever; Rash or hives are on her legs, thighs, neck, back, and head; Rash or hives are on her legs, thighs, neck, back, and head; This is a spontaneous report from a contactable nurse (patient husband). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: EL3247, Expiration date: 31May2021) via an unspecified route of administration in the right arm on 01Feb2021 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient relevant medical history included allergy. The concomitant medication was not reported. The patient previously took septra and experienced allergic to septra (she had taken many years ago. She took something and developed an allergy, but she hasn't used it in maybe 20 years). It was reported that patient received first dose of the Pfizer COVID-19 vaccine on Monday (01Feb2021) and she felt good, then late Tuesday she got a rash at 09:30 (about 30 hours after her injection) and a fever on (02Feb2021), which was listed on the brochure and was kind of expected, but he wanted to be reassured this was ok and not something like a severe allergic reaction. It was reported that patient second dose was scheduled for 22Feb2021. It was reported that patient has been taking Benadryl 25mg, 50mg total a day, 25mg one in the morning and then one in the evening by mouth. The reporter informed that the benadryl (Lot number: P119020, EXP: Feb2022) seems to calm the rash down, though it was more like hives than a rash. It was reported that patient had rash or hives are on her legs, thighs, neck, back, and head on an unknown date in Feb2021. The reporter told that the rash was not getting worse, and Benadryl seems to help it. The reporter told that the vaccine instructions they got said it was possible to get a rash or have a side effect, he just wanted to be reassured. Therapeutic measures were taken as a result of rash, rash or hives are on her legs, thighs, neck, back, and head. The outcome of the event fever was unknown while for other events was recovering.

tiredness; headache; muscle pain; chills; feeling unwell; injection site soreness; This is a spontaneous report from a contactable nurse (patient herself). A 76-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 31Jan2021 at 08:00 AM (at the age of 76-year-old) at a single dose for COVID-19 immunisation. The patient's medical history included coronary artery disease (CAD), hypothyroidism, and sleep apnea. Concomitant medications included levothyroxine, carvedilol, latanoprost, and amlodipine besilate (AMLOD). The patient previously took meperidine (DEMEROL) and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced tiredness, headache, muscle pain, chills, feeling unwell, and injection site soreness on 31Jan2021 09:00 PM. The patient had not taken any other vaccine in 4 weeks. The outcome of the events was recovering. There was no treatment given due to the events. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the Lot/Batch number has been requested.

Pain and swelling (about the size of a boiled egg) on the shot site; Pain and swelling (about the size of a boiled egg) on the shot site; Cold hands and feet after receiving shot; My right hand also was numb and needed to be rubbed to increase circulation; Fever; joint aches; headache; This is a spontaneous report from a contactable consumer reported that: A 76-years-old female patient received bnt162b2 (BNT162B2; Manufacturer Pfizer-BioNTech), via an unspecified route of administration, administered in Arm Right on 26Jan2021 (Batch/Lot Number: EL9261) as SINGLE DOSE for COVID-19 immunisation. Medical history included cerebrovascular accident, allergic to sulfa drugs (drug hypersensitivity). The patient received concomitant medications included losartan (LOSARTAN), atorvastatin (ATORVASTATIN), vitamin b12 nos (VITAMIN B 12 [VITAMIN B12 NOS]), acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were unknown. The patient did not receive any other vaccines with in four weeks. 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 27Jan2021 03:00, the patient experienced Pain and swelling (about the size of a boiled egg) on the shot site. Cold hands and feet after receiving shot, including all night. My right hand also was numb and needed to be rubbed to increase circulation. Fever, joint aches, headache. The patient underwent lab tests and procedures which included body temperature: results unknown .Outcome of the events were recovered on unspecified date.

Headache first and 2nd day. A week later woke me up 2 nights in a row but only lasted 12-15 minutes. Skipped heart beats day after and the next am, none since. Rash of red irregular dots about the size of a pencil eraser with bumpy raised flesh directly on veins. started 2 weeks after, lasted 4 days, loss of appetite, much more intense joint pain and sleeplessness which comes and goes.

Red rash under left breast and down side; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN9581, first dose) solution for injection intramuscular in the left arm on 02Feb2021 at 15:00 (at the age of 76-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure. Concomitant medications were not reported. Past drug history included known allergies: amoxicillin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 02Feb2021, the patient experienced red rash under left breast and down side. No treatment was provided for the event red rash. The outcome of the event red rash was not recovered. Since the vaccination, the patient has not been tested for COVID-19.

Bright red blotches on both knees & just below the knees. Seen at 2:15 pm. No other symptoms. Redness is fading now at 3:30 pm.

Headache and was hot; really hot at night; Really strong muscle and joint aches/pain; Really strong muscle and joint aches/pain; fever; White bump near injection site.; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL9262 and expiry date: 31May2021) via Intramuscularly to left arm on 22Jan2021 10:30 at single dose for COVID-19 immunization. Patient medical history included bladder infection, blood pressure, she has some old age stuff like blood pressure, and she had Thyroid removed and takes a thyroid pill every day and she tends toward GERD. Concomitant medications included she does take other medications, but they are not relevant. Patient previously took Shingles shot for Shingles (Had the first of the Shingles shot but it was before that. She is due for the second one but she is putting it off for the COVID second dose). Patient reported that she got the COVID vaccine and was really excited because seemingly, she had no side effects. The shot did not hurt. Ten days after she go the shot, she got really hot at night and really strong muscle and joint aches on 31Jan2021. She was up almost all night. It just kept waking her up. So, she took something, an Ibuprofen thing to reduce fever and pain. The next night she took one proactively and did not have pain. The third night, she had it again but it was a headache all night and she was hot on 02Feb2021. It only seemed to happen at night. She felt like it was from the vaccine. She was not worried she had COVID. She had no breathing problems and did not feel like she was going to pass out. They said she should wait 48 hours and take a test to see if she had COVID. She did and it was negative. She does not feel any negativity toward the vaccine. She went in for a bladder infection and it was from a doctor's appointment that she got information and they told her she could go ahead and get it. Since she got the vaccine, she got white bump in the vicinity of the vaccine like a while mole, and another in the vicinity of the area as well. It does not itch or hurt. She noticed it about a week after the shot. She does not know the date. She was still on medication for a bladder infection but it would not have done anything. When she had reaction to the vaccine, it was already 10 days after she got the shot. She had asked them at Kaiser, and they think it was unrelated to any other medication. Outcome of event fever was recovered on 01Feb2021, for white bump near injection site was not recovered and recovering for all other events.

2 degree temperature and feeling hot; arm swollen with egg size lump; rash on arm 2inch x 4 inch; extreme fatigue ; red cheeks; and 10 days later JAW HURTING which persists to date

Felt much like I did when I had COVID virus and after the first short. In bed for almost 2 days. No fever but just felt awful. Did not eat or do anything. Worst part was the intense pain at injection site in right arm. Pain was excruciating and it took 6 days for it to subside. Sleeping was especially problematic.

Phizer-BioNTech COVID-19 Vaccine EUA Injection site pain, tiredness, headache, chills, fever, nausea, feeling unwell, dizziness & weakness

redness and slight bruise at injection site. warm to the touch. began 6 days after 2nd injection. did not notice until 6th day although not sure if it was there before. Monitored the area for side effects 2-3 days after the 2nd injection and only small, slight redness at that time. very little soreness immediately after 2nd injection.

Intense pain in left knee. Red and swollen. Reports that she was screaming in pain and couldn't put any weight on it. taken by ambulance to ER. They completed a CT Scan and an ultrasound but found nothing. No med given helped with pain. She sent us an email on 3-23 and I called her. She is still experiencing pain (better) but has to use a walker to ambulate.

3/5 Anxiety attack with increased heart rate ...lasted about 20 minutes after taking one half of a cyclobenzaprine and full glass of waterand deep breathing; had another evening of March 10. much shorter duration.. After second shot, day after slight headache and bone tired...tiredness continues to present and my head feels like is has a vise or a helmet on it. Also have developed a kind of dermatitus but don't know for sure if I had it before and didn't realize it. I just want to sit down or lie down...My leg/butt muscles feel not up to the job...and in general thru today I just feel "off". Some days better than others.

Back hurt a tremendous amount; Lower back, hips, knees, neck pain; Lower back, hips, knees, neck pain; When she would go to move her eyes left or right or up or down it seemed like her eye sockets just hurt to move her eyes.; Very sore, uncomfortable stomach; Exhausted; Chills; Felt like she was having a heart attack; a bit congested; Aches; jaw pain; facial pain; Quite a bit of saliva in her mouth, it filled up quite a lot; sore on the injection site; Bit of a sore arm/left arm pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Right Arm on 02Mar2021 14:26 (Batch/Lot Number: EN619G) as single dose for vaccination. Medical history included joint replacements (specified as 1 hip done in 2007; right knee done in Jan2013; another knee was done in Feb2017; another knee was done in 1986); and in 2011, neck fracture. There were no concomitant medications. The patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE and on 02Mar2021, she had sore on the injection site, experienced excess saliva production. On 05Mar2021, she experienced chills, feeling of heart attack: left arm pain, jaw pain, facial pain. She is worried to take the 2nd shot as she might have more symptoms on the 2nd dose. On an unspecified date, the patient had lower back, hips, knees, neck pain, eye socket hurts when rolling her eyes, sore stomach, and exhausted. It was also reported as follows: on 02Mar2021 after she got home from being administered the Pfizer-BioNTech COVID-19 Vaccine she had quite a bit of saliva in her mouth, it filled up quite a lot; and a bit of a sore arm for a couple of days but that was about it at that point. On Friday, 05Mar2021 she started getting chills and aches; and felt like she was having a heart attack: her left arm hurt and her left side of face hurt down in her jaw. She was afraid and considered going to the hospital but thought she was going to wait it out see what it is and it passed. She then once again got a lot of saliva in her mouth again. Over the next few days she developed aches that were primarily located in her joint replacements, it seemed like the aches attacked those areas of joint replacements in her hips, knees and where she had a neck fracture. She had a lot of pain and a lot of chills. She was never bedridden, but would lay down because she was exhausted. Her back hurt a tremendous amount. Another thing that happened is her eyes, when she would go to move her eyes left or right or up or down it seemed like her eye sockets just hurt to move her eyes; she did not have a headache; this whole indentation there with her eyes hurt to move them from one side to another. She also had a very sore, uncomfortable stomach; it was not an upset stomach; just seemed very sore, uncomfortable. At first that first part of 05Mar2021 she seemed a bit congested. She is very worried about second dose of Pfizer-BioNTech COVID-19 Vaccine because of the first dose creating all of these difficulties. She does not know what she should be doing. She is scheduled to get her second dose of the Pfizer-BioNTech COVID-19 Vaccine on 24Mar2021 because she is leaving by plane on 29Mar2021. That only gives her like 4-5 days before she leaves and she knows that the other symptoms after the first dose of the Pfizer-BioNTech COVID-19 Vaccine did not start until 3 days later. She is concerned about that, because she is flying to take care of her sister; she is worried about the second dose because she does not like what she experienced with the first dose because she heard that the second dose will be terrible; she is worried about leaving and experiencing those horrible things. She reported that there are no tests/investigations relative to this report to provide. The only thing recently done was having X-rays of her neck on 24Feb2021 because of her neck issues with the fractured neck she had in 2011. Outcome of the events was unknown.

she did not have a reaction to first. After the second she got very cold and felt miserable like her legs had weights on them- this only lasted 1-2 days. Then two weeks later she got a ring around the injection site- and developed intense itching, burning, and erythema and warmth at the site and axillary lymph node swelling. The muscle on her arm were tender and swollen as well. The lymphadenopathy, and arm pain and swelling lasted for over a month. Pfizer : Lot: 12831/8/21 Lot 9261 1/25/21

Gradual eruption of hives with worsening itching, almost all on the right side of my body, with eventual swelling of my face, mostly on the right side, to the point of nearly closing my right eye.

She had welts and little red spots all over her back a couple of hours after the second dose of vaccine. She got rubbed down with alcohol and cortisone cream that night. Today, the back welts went away but the red spots are still there. After checking her again around 8:30 p.m. because she complained of her left hand itching, I noticed more welts up her left arms and more came back on her middle and upper back. She was then rubbed down again and given an ibupropean. I am unsure of this side effect because it was not mentioned on any cdc website, so therefore I will be calling her physician to do a checkup. If there is any other information we need to know on how to treat the outbreaks please send email.

Tongue Enlargement, tingles around mouth, itchy ears and axillae, shortness of breath - Benadryl 25mg PO given

On Sunday at 10:00PM she checked her temperature and it was 100.6 degrees; she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly; she felt some slight joint pain in her left knee; she didn't feel good; she felt off balance after receiving her second COVID-19 Vaccine dose. She said she only felt off balance the first day after she received her second vaccine shot.; felt a little off; Chills; Ache; Headache; Injection site pain; soreness under her left arm; This is a spontaneous report from a contactable 76-year-old female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264), via an unspecified route of administration on 06Feb2021 17:15 at single dose in arm left for covid-19 immunization. The patient historical vaccine included BNT162B2 on 16Jan2021 for COVID-19 immunization and he she had Injection site pain (Lot Number: EL3247, Expiry Date: Unknown, Route: Intramuscular, Anatomical Location: Arm, Left, No. of Previous Doses: None) and about 10 years ago she had a flu shot, and she had a reaction that felt like she got the flu for a day. On 07Feb2021, the patient woke up and she felt a little off in the morning. On Sunday afternoon, between 1:00-2:00PM, she had chills, felt achy, slight headache and she didn't feel good. She said she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly. She said it dawned on her at 10:00PM Sunday night that maybe she had a temperature. She said she checked her temperature, and it was 100.6 degrees. She said she called to ask a nurse if she could take Tylenol for her fever. She said she had read about not taking Tylenol with the COVID-19 vaccine, but nurse told her it was OK to take Tylenol. She said she felt some slight joint pain in her left knee, too. The patient stated that she had a little bit of injection site pain with her first COVID-19 Vaccine shot. She said she thought the injection site pain was due more to where the COVID-19 Vaccine shot was given, and not from the COVID-19 Vaccine itself. She said with her second COVID-19 Vaccine shot, she had pain at the injection site and soreness under her left arm. The patient took the generic Tylenol Pain Reliever 325mg for her fever and chills. The outcome of the event felt a little off, ache and didn't feel good recovering on an unknown date, chills, headache, temperature was 100.6 degrees resolved on 08Feb2021 and she was cold, had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly were resolved on 08Feb2021. injection site pain and soreness under her left arm resolved on 10Feb2021 and She said she only felt off balance resolved on 07Feb2021.

she felt like she was dying, it was a strange feeling, like out of body feeling, she knew she was feeling sick; fall; bladder issue; sinuses; body aches; she was miserable; this was painful than the other shots she has taken; Chills; she was worn out/She was tired; nausea; Malaise/feeling sick; her "armpit" hurting; muscle and joint pain; muscle and joint pain; headache; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCIN) lot number: EL3247, via an unspecified route of administration, administered in left arm on 10Feb2021 as single dose for COVID-19 immunisation. Medical history included multiple sclerosis, Chronic obstructive pulmonary disease (COPD), overactive bladder, osteoporosis, sinus headache, allergies also bother her, back issues, and broken femurs from 2019. Concomitant medications were not reported. The patient received her first dose of the Pfizer COVID vaccine on 10Feb2021 and is due for the second dose tomorrow. The patient stated that she has really heavy reaction from the first dose, she felt like she was dying, fall, bladder issue, had headache, nausea, sinuses, body aches, muscle and joint pain, she was miserable, her "armpit" hurting, this was painful than the other shots she has taken. The patient wanted to know if its ok to take her nebulizer and other pain medications she is taking generic for Norco. The patient clarified that she had headaches, feelings with her muscles and joint, nausea, and then there was the big symptoms that hit her, she felt like she was dying, it was a strange feeling, like out of body feeling, she knew she was feeling sick. She herself didn't know what was wrong and so she couldn't go to the ER, she doesn't know what this is, it lasted 24 or more hours. The patient stated that it was the malaise, she's never had malaise before, it scared her. She is getting the second dose tomorrow and she is scared to death. The headache, muscle and joint pain and armpit hurting started 10Feb2021 while nausea and malaise/feeling sick started on 11Feb2021. The patient recovered from the event armpit hurting and malaise/feeling sick on an unspecified date. The outcome of the event headache, muscle and joint pain, was not recovered. The outcome of other events was unknown.

transferred from shoulder to her neck; shoulder was in pain/ elbow and shoulder were in pain; injection area is a little sore; I cant sleep at night; She can't position her arm in a way that is not painful; deep muscle ache pain; she was miserable; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9266, expiration date: Mar2021), via an unspecified route of administration in left arm on 23Feb2021 as single dose for COVID-19 immunization. Patient's medical history included stomach problem and bleeding problems in her stomach. There were no concomitant medications. The patient said that absolutely everything was okay until she went to get the shot, and was even okay the evening of the shot, then it went down hill from there. She said nothing she has that is related to the pain in her arm, or that she feels she should provide. She did not had any other recent vaccinations or started any new medications. The patient stated that the injection area was a little sore and the area became bigger and bigger by Wednesday (24Feb2021). She woke up on Thursday (25Feb2021) and her elbow and shoulder was in pain, described as a dull pain. The patient stated she has a stomach problem where she can't take medicine. She started treating her pain with aspirin cream with Lidocaine. She said that its kind of worked, it didn't take it away, but more manageable. Now it's been 6 days later (01Mar2021), it was reported a deep deep pain in the point she can't sleep at night. She can't position her arm in a way that is not painful. It was getting unbearable. It transferred from shoulder to her neck on Friday (26Feb2021). It got worse Thursday evening and has been the same since. Patient said, "I am not going to get the second shot if this pain does not go away or if I am going to experience this again." The patient was calling about a possible side effect and was wondering if anyone else had it and does it go away. She was suffering, she wanted to know if the pain she is in, that she is still experiencing will go away. She said that she had a deep muscle ache pain to the point she can't sleep at night. Patient stated that her pain began as soreness at injection site that started Wednesday and then it just got worse and worse and became deeper and deeper just between her shoulder and elbow, a deep constant achy pain. During the day when she is using her arm she can kind of forget the pain, but at night there was no comfortable position she can put her arm in without pain, so she has not been sleeping the last 3-4 nights, she can't sleep, she was miserable. She said she would rather get COVID than this, it was ridiculous. As she has bleeding problems in her stomach, she can't take anything to treat the pain, so she was trying to use lidocaine on her arm, which did at first give some relief but no longer works. She said that the only number listed on the bottle was next to "EXP date, LOT: 19C506, EXP: Mar2021 (as reported)." The outcome of the events was not recovered.

nauseas; hot flashes; slight sore throat; feel a little punk; slight soreness at injection site in my left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EL9264; Expiration Date: unknown), dose 1 via an unspecified route of administration in Arm Left on 04Feb2021 09:00 as SINGLE DOSE for COVID-19 immunization. Medical history was unknown. There were no concomitant medications. The patient experienced slight soreness at injection site in my left arm (vaccination site pain) on 04Feb2021 with outcome of recovered, feel a little punk on 08Feb2021 with outcome of unknown, nausea, hot flashes, slight sore throat on 09Feb2021 with outcome of not recovered. The patient is scheduled for the second dose on 25Feb2021. No follow-up attempts are possible. No information is required.

redness and swelling at the injection site however this morning she woke up and it was itchy; redness and swelling at the injection site however this morning she woke up and it was itchy; redness and swelling at the injection site however this morning she woke up and it was itchy; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL3249), NDC number, expiry date; unknown, Is COVID vaccine a Pfizer product; Yes, COVID vaccine manufacturer; unspecified via an unspecified route of administration from 01Feb2021 to 01Feb2021 at single dose on right arm (by injection once to right hand shoulder) for prevent from getting COVID. Identification of the country where the drug was obtained. Country of authorization/application;. Patient (weight; 60.78 kgs, height; 163 cm) was 76 years old at the time of vaccination. Patient's medical history and concomitant medications were not reported (Other Products; No, Patient History; No). Caller received the vaccine on 01Feb2021 and experienced right away the redness and swelling at the injection site however this morning she woke up and it was itchy, as well as the redness and swelling. Caller had Pfizer shot two weeks ago, the COVID vaccine, everything was fine, but this morning, on 09Feb2021 her arm is itching, red, and swollen at the shot area, is that normal? Reporter email address declined. She stated it was itching really bad, she got her bath, and it looked red and swollen and was sore. Primary care doctor's address, phone number, and email address unknown. Vaccine card has the return shot date of 15Feb2021, the card doesn't have the date of the first shot. The outcome of events was not recovered.

Itching mostly on face and scalp.; This is as spontaneous report received from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264) via unspecified route of administration in the right arm on 11Feb2021 at 01:00 PM (at the age of 76-years-old) as a single dose for COVID-19 immunization. Patient's medical history included glaucoma, dry eye and allergy to tetracyclin. 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 hydrochlorothiazide, omeprazole, alendronate and latanoprost. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Restasis, dorzolamide thymol, PredMild, Rhopressa, Latanoprost, Artificialtears, Night gel, Biaxin and expereinced allergy. On 12Feb2021 the patient had itching mostly on face and scalp. No teatment was given to the event. Outcome of event was resolving.

Pfizer-BioN Tech COVID-19 Vaccine EUA: Swelling in mouth/lips, severe itching (all over, especially legs, thighs, back, arms, scalp, eyebrows and in nostrils, sensitivity to sound, elevated blood pressure, swelling in ankles, nausea

She got the vaccine, when she came home she started feeling the fatigue that she felt after the 1st vaccine. She then started feeling very cold, laid down and watched TV. She then had chills all night and did not sleep well due to that. When she got up on Tuesday the chills were gone but had a slight headache off and on throughout the day, her temp was 97.2. Throughout the day she would get warm spurts/hot flashes, as well as fatigue. She did sleep that night, and when she got up yesterday morning still had the hot flashes and it was 94.2, and took it twice due to it being so low. She was like that with fatigue and not able to sit up. She went to bed, took some Tylenol and rested. The heat feeling it started going away. Around dinner time she felt more like herself, the headache was gone and her temp was 97. She was doing pretty good, and the last thing she had was she felt on her cheeks and noticed a rash on her face, like a prickly heat type rash. Before she went to bed she put Neosporin on it, and when she got up this morning it was almost gone but still has a tiny few bumps. The arm itself did not hurt at all. Feels that it is a stressful situation as to where to get the vaccine and having to travel to get it as it's not available in locations closer to their homes. The people at the pharmacy were great, but had to travel and if it wasn't for her daughter she would probably not have her shot.

I have a huge red spot on one and I have the little dots, red dots on the other; I have a huge red spot on one and I have the little dots, red dots on the other; This is a spontaneous report received from a contactable consumer, the patient. A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration date: Unknown) via an unspecified route of administration on 18Feb2021 (at the age of 76-year-old) as single dose for covid-19 immunization. On unspecified date the patient reported to have a huge red spot on one and little dots, red dots on the other (Rash macular/Erythema). The outcome of the events was unknown. Information on the lot/batch number has been requested.

Right side of face swollen so the eye was almost invisible; rash on face, neck and hands, some on the upper right back; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955, expiry date: unknown), via an unspecified route of administration in the right arm, on 19Mar2021 08:30, as single dose, for COVID-19 immunisation. Medical history included Alpha gal (allergic to all mammal protein). The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medications included hydrochlorothiazide; pravastatin sodium (PRAVASTINE); famotidine (PEPCID AC); and loratadine, all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6200, expiry date: unknown), via an unspecified route of administration in the left arm, on 22Feb2021 08:45, as single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 19Mar2021 at 12:30, the patient experienced right side of face swollen so the eye was almost invisible, rash on face, neck and hands, some on the upper right back. The events resulted to emergency room visit. Treatment included prednisone and Benadryl. The patient was recovering from the events.

Itching/itching at the injection site; injection site and area around it is really red; This is a spontaneous case received report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 20Feb2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. No prior vaccines were administered within 4 weeks. The patient experienced injection site and area around it was really red on 21Feb2021; itching/itching at the injection site on 22Feb2021. The patient did not undergo any lab data or investigations. The outcome of the events were not recovered. Follow-up attempts are completed. No further information is expected.

Patient noted that 2 days after vaccination that her left shoulder became very sore and achy. She was unable to left her shoulder. She denied redness or swelling at the site. Used tylenol. Did not contact MD. States her shoulder hurt for approx. 3 weeks post vaccination. Was massaging her arm to help relieve pain and it eventually felt better. Also shared that her left thumb also was sore and reddened post vaccination but unsure if it was related. Does not recall an injury.

One week after last shot developed shingles. treatment to date consist of at home methods to reduce pain and itching along path from back to center to edge of right breast. All rash is on my right side. Seven days since beginning of rash which proceeded by five days of back pain before realizing what was happening. Tried acetaminophen for pain relieve but developed a rash on arms and legs with intense itching and had never had a reaction before to this medicine. My immune system is not acting as it normally does.

Petechiae below the right knee. Per the patient, she also experienced this same rash when she had COVID-19 disease back in December 2020.

It was very sore; Getting a reaction and it started to turn red; it keeps spreading on my arm it's from below where the shot was; Going around the arm and it's kind of like a burning itch; it is annoying; little redness on my arm; allergic to the preservatives in the vaccine; Going around the arm and it's kind of like a burning itch; it is annoying; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and expiration date was not provided), via an unspecified route of administration on 17Feb2021 as single dose for covid-19 immunisation. Medical history included ongoing cholesterol. Concomitant medication included rosuvastatin taken for cholesterol, start and stop date were not reported. Historical vaccine included FLU for patient had a Flu Shot but it only got little red, little redness on my arm and first dose of BNT162B2 (Lot number: EN6200, Expiration date: Jun2021) via an unspecified route of administration on 27Jan2021 for Covid-19 immunization. Patient stated, "patient got the Pfizer second shot on Wednesday (Clarified as 17Feb2021) patient arm didn't start to bother me or it was very sore (Further clarification was unknown if consumer's arm was sore or not, hence captured as event) but then on Friday patient noticed patient was getting a reaction and it started to turn red so patient had an allergic reaction to it, except that it keeps spreading on patient arm it's from below where the shot was, it didn't hit the elbow yet but it is going around the arm and it's kind of like a burning itch it's not something terrible it's not something patient cannot deal with but patient was concerned about it and patient wondering if there is something patient can take or do because it is annoying on 19Feb2021" Patient believe because patient had a Flu Shot (Captured as provided) but it only got little red. patient think patient was allergic to the preservatives in the vaccine (COVID-19 Vaccine) because a friends of my works in a doctor's office and she was with me and she said I am probably allergic to, what you call the preservatives in the vaccine." Patient stated, "No it's been a while, it's been, you know it was just a little redness on my arm on 19Feb2021." Patient received a treatment that put some Ice on its last night and then patient took a Benadryl, you know generic Benadryl from a Walmart. The patient underwent lab tests and procedures which included Cholesterol and Urine: unknown results on an unspecified date in 2021. The outcome of the events was unknown. Information on Batch/Lot number has been requested

rash that started on the left arm 2 days after the injection. monitoring the rash for now. it is asymptomatic outside of pink rash with slightly raised border

Two weeks after receiving vaccine, experiencing severe pain in under left breast, radiating around to the back. Chest pain and some breathlessness. I took her to the ER , on March 27, 2021, thinking it might be her heart. She was admitted for observation. She broke out with a severe case of shingles the next day, 3/28/21. She had been fully vaccinated for Shingles two years before (Shingrix).

Injection site pain; Tiredness; Headache; Chills; Fever was 101.6; Injection site redness; Nausea; Not feeling well; Felt bad; Weakness; Soreness arm; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 21Feb2021 at single dose for COVID-19 immunisation. Medical history included Pulmonary hypertension and high blood pressure from an unknown date and unknown if ongoing. Patient previously took first dose of vaccine for Covid-19 immunisation. Concomitant medication not reported. When probed for the concern, consumer stated, "I was just calling to pass on my experience with the second vaccine. I ended up having all of the side effects that you had listed. I have injection site pain and redness and it still is as up today and I had the injection on Tuesday (23Feb2021). I had tiredness, headache, chills, fever and my fever was 101.6, injection site redness, nausea and basically not feeling well and I also had some weakness and I think that was because, I mean I felt so bad I was pretty much in bed and today is my first day up since Tuesday." The patient underwent lab tests and procedures on unspecified date which included Body temperature: 101.6. The outcome of the events Injection site redness, Soreness arm was reported as not recovered and outcome for other events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

rash; This is a spontaneous report from a contactable consumer reported in response to Non-HCP follow-up letter sent in cross reference case. A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation causes pain, right knee-could barely walk and all of her joints that had been previously hurt in the past started killing her. The patient experienced rash on 16Feb2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was recovered. Information on the lot/batch number has been requested.

Extreme pain, went to ER and morphine didn't do anything so they gave me something stronger than morphine. Was released and sent home to which the pain got so bad when the med wore off that the following morning I was in the ER again. I also had a fever of 102.3 and a rash (red bumps all over my chest, stomach, back of neck and shoulder back area, nausea, chills. this lasted exactly for 5 days and then was gone.

Only has a little pain on my arm where I was given the shot; This is a spontaneous report from a contactable consumer reported for herself in response to Non-HCP letter sent in cross reference case. A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included heart rate increased, blood cholesterol increased, hypertension from an unknown date and unknown if ongoing. Concomitant medications included ongoing metoprolol 25mg, twice daily, lisinopril 5mg once daily from Jun2020 for hypertension, ongoing atorvastatin (LIPITOR (ATORVASTATIN) 20 mg once daily from Jun2020 for blood cholesterol increased, ongoing levothyroxine, diphenhydramine hydrochloride (BENADRYL) from an unknown date to unknown date for unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration (Lot number: EL9261) as SINGLE DOSE for covid-19 immunisation causes rapid heartbeat was monitored, it keep going up and down/went to the emergency room. The patient only has a little pain on my arm where i was given the shot on an unspecified date. Drank a lot of water before after shot, Nurse suggested taking Benadryl after the shot which I did and had no reaction. The patient underwent lab tests and procedures which included heart rate increased: 135-120-110 bpm (Normal BPM 55-65 was up to 135-120-110 etc after vaccine (1st shot)), heart rate normal: 55-65 bpm (Normal BPM 55-65). The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown. Information about batch/lot number has been requested.

Rash; itching from the injection site; pain on right arm; swelling on the Right arm; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (BNT162B2, Lot Number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Right on 20Feb2021 13:15 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Verbatim: Asthma, hypersensitivity from an unknown date and unknown if ongoing Verbatim: Allergy. On 22Feb2021, the patient experienced rash, itching from the injection site, pain on right arm, swelling on the right arm. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of rash. The outcome of the event rash was recovering, and rest event outcome was unknown. No follow-up attempts are possible. No further information is expected.

Facial and eye Shingles began (4/16/21) three weeks after second shot. Saw PA of Dermatology and received Valacyclovir. Saw Dr. OD and received Prednisolone. Saw of Wellness Center and received more Valacyclovir.

Severe case of Shingles; This is a spontaneous report from a contactable consumer (patient). This 76-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 06Feb2021 at 09:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines with 4-weeks prior to the COVID vaccine. The patient had no allergies to medications, food or other products. Concomitant medications included amlodipine besylate from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number unknown) on 16Jan2021 at 09:30 (at the age of 76-years-old) in the left arm for COVID-19 immunisation. The patient reported she contracted a severe case of shingles on 12Mar (2021). The event required a doctor or other healthcare professional office/clinic visit and the patient was treated with valacyclovir. The clinical outcome of shingles was not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

eczema; had rash and itching on the front of her chest and stomach area and spreaded all over the front and then went to the back; had rash and itching on the front of her chest and stomach area and spreaded all over the front and then went to the back; This is a spontaneous report received from a contactable health care professional (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265, Expiry date: Unknown) on 28Jan2021 at 11:40 (at the age of 76-years-old) via unknown route at single dose on high on left upper arm for COVID-19 immunization. Relevant medical history included cold sores in nose and mouth. The patient was allergic to morphine and the morphine family drug. She had reaction when she had her hysterectomy (Occurred just one time and was years ago). The patient takes one prescription for her thyroid. The patient also had a medical history of Herpes and shingles. On the same date 28Jan2021, after 4 to 6 hours of vaccination (at 16:00 to 17:00) the patient had rash and itching on the front of her chest and stomach area and spreaded all over the front and then went to the back. The patient did not have rash on arms and legs, only on torso. She had no trouble in breathing and swelling. The patient also had eczema immediately after the COVID-19 Vaccination and she does not know her stress might have triggered it.The patient wants to know whether she should receive the second dose and if the second dose would cause a worse reaction than the first time. The patient prescribing physician told it did not sound like anything serious, just a mild reaction. A week later the patient went to dermatologist. Both her doctor and dermatologist stated it does not sound like it was severe. The patient's dermatologist stated it was a mild reaction rash and itching and told her it was fine to receive the second dose. The patient to get a steroid cream to get rid of the itch and rash. The patient was anxiety and stuff from not living normally. The patient worked in a retirement and nursing home for a very short time, but was never a physician, pharmacist, or nurse. She received treatment with triamcinolone ointment 0.1 percent. The action taken in response to the event(s) for BNT162B2 was not applicable. Outcome of the events ‘had rash and itching on the front of her chest and stomach area and spreaded all over the front and then went to the back' and eczema was unknown.

Rash; would call it hives; very itchy; Rash; would call it hives; very itchy; Rash; would call it hives; very itchy; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 02 patients (wife and Husband). This is 1st of 02 reports. A 76-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included type 2 diabetes was diagnosed A lot of years ago, she thinks in 1995, heart problem. Concomitant medication(s) included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported. Insulin was administered via pen, once a night. The patient stated that for diabetes, she takes a lot of medications and there are several of them. Consumer further stated that she has preventives for heart problem. She has been using and is on them permanently. Consumer stated, "They are all taken orally." She thinks her weight, it's like 180 pounds somewhere around there and she was not sure. The patient experienced rash; would call it hives; very itchy in Feb2021. Consumer stated, she had a side effect but she don't know if it's a side effect that you have. It's not listed on the sheet that she got when she got her shot of our vaccination. The patient had a rash. She would call it hives. They itch like double. There were a couple of on her right shoulder, she had two on the back of her left calf, on her leg and she had on her whole left arm where the vaccination shot was put in, completely covered in hives and they were very itchy. Consumer further stated that she wants to know what to do about it. The itch was like double, and this had been day 4 and she had the last, the second vaccination on 4th Feb on left upper arm. She wanted to get rid of these hives. They were driving her nuts. Consumer stated, 4 days ago, 19Feb 2021, somewhere around that she started having the events. Consumer further stated that she wants somebody to tell her what she was supposed to do. She don't want to go through all this stuff. She enquired what to do about these hives. The patient had got Calamine lotion, it's calamine topical suppressant and she had got Wal-dryl, it's a generic for Benadryl as treatment. The patient was still experiencing the adverse events and stated otherwise she wouldn't be calling. They were still there, it's still driving her nuts. The patient has not done lab test. She has got to do it another month. Outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021219067 same drug/same event, different patient.

Her legs got weak; she lost coordination; anxiety was exacerbated by her terrible fatigue; depression was exacerbated by her terrible fatigue; nervousness was exacerbated by her terrible fatigue; nervousness was exacerbated by her terrible fatigue; She noticed that her blood pressure raised after receiving the first dose of the covid vaccine.; Total exhaustion/she is so tired; could not sleep; She experienced pain at the injection site./Her pain got worse and worse; left or right toe will get stuck; hysterical; she is stressed; did not have complete energy; She states that her illness is too much; This is a spontaneous report from a Pfizer sponsored program received from a contactable healthcare professional (patient). A 76-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 intramuscularly administered in the right deltoid on 30Mar2021 10:00 (Lot number: GR8732 or 6R8732 [as reported]; Expiration Date: 31Jul2021) as a single dose for covid-19 immunisation. Medical history included blood pressure/hypertension; had breast cancer twice with the last time was in 2010 to unknown date which was 23 years later than the first time she had it (1987). She had infiltrating ductal cancer, stage one, that was HER-2 positive. She states that this is the most malignant breast cancer. She had to have extensive chemotherapy and also took Herceptin every 3 weeks for a year. The overriding symptom from her cancer was extreme fatigue; has been in chronic fatigue syndrome and in bed for 7 years, she was getting over chemo and she can barely walk. She has trouble walking long distances; had a mastectomy from 2010 to an unknown date without lymph node dissection; had a central node dissection; took a wheelchair to the hospital whenever she received the first dose of the covid vaccine; ongoing anxiety, depression and nervousness which is not new to her. She has had this on and off for the past year; and antihistamine that raises her blood pressure dangerously, it does not matter which kind of antihistamine whether it is Benadryl or over the counter. The only antihistamine that does not raise her blood pressure was a children's allergy medication. She took half of a children's dose. It did not raise her blood pressure, but it did not stop her itching. Family history included her mother's sister and she are very sensitive to medications. She has the same type of problems. As her mother's sister has aged, her problems have gotten better. As caller gets older, her problems are getting worse. Concomitant medication included carvedilol taken for blood pressure on unknown therapy dates. The patient previously took dupilumab (DUPIXENT) for skin conditions that having itching which she had side effects (Lot number: 0LU23A; Expiration date: Feb2023). Dupixent is a medication used for skin conditions that having itching, not cirrhosis, she cannot remember the name of the skin condition. Her skin started itching around Jun2020 or Jul2020. She saw eight different dermatologists. She found a doctor who was an itch specialist. Dupixent is the only thing that is going to work for her because antihistamines raise her blood pressure dangerously; and one time her doctor made a mistake, he ordered her hydroxyzine 25mg PO (Per oral). The doctor did not look on her chart to see her allergy list. She cut the pill in half and took half a dose. By the time she realized what she took, she was having so much itching. She woke up and felt like her head was going to explode and her blood pressure was 220/112. She took three tablets of her antihypertensive medication. She taken carvedilol 3.125mg. She did not even bother going to the hospital because by the time they would have saw her, and treated her, she could have had a stroke. The hospital is slow to treat people. Because she is a nurse practitioner, she knew that 3 tablets would be the correct dose for how high (Apr2021) her blood pressure was. She also previously took Benadryl but that raises her blood pressure dangerously. The patient reported that she received her first dose of the covid vaccine on 30Mar2021 and she had many side effects. She reported that the most predominant symptom is total exhaustion. For the first seven days after receiving the first dose of the covid vaccine, she was in bed for seven days nonstop. She placed a large grocery shopping order. She was able to get up and use the bathroom and cook small meals. She had someone come in to help her with the dishes, and to clean up the house. She talked to her internist of 20 years, and he told her to take the vaccine. Within five minutes, she started getting side effects. She inquired if it was safe to take the second dose of the covid vaccine. She has been so fatigued that she has been in bed for a 3 weeks-time frame and then her Blood pressure went up, it was 200 something, like 223/103. She went to the ER, and the ER said her blood pressure was not bad (Apr2021), they put her in the waiting room, and because she waited so long, she just got up and left the ER. Since she is so tired and her Blood pressure is high, she has made an appointment with the doctor. She added that the second week after receiving the first dose of the covid vaccine, she was able to get up every other day and go somewhere but the next day after she went somewhere, she was in bed all day and did not have complete energy (2021). She added that her refrigerator was going out, so someone drove her to department store 30 minutes away. She walked from the car, to the refrigerator section in department store, walked into the mall to get ice cream and then walked back to the car. By the time she got home, she immediately got back in her bed because she was so worn out. That was on Saturday. She was in bed all day yesterday. This morning, she feels better than yesterday. She thought about going to the store yesterday, but she knew she did not have the energy to go. Someone is coming later today to help her, and they will have to go to the store for her since she does not have any family nearby. She mentioned that the total exhaustion began on 31Mar2021. She took a wheelchair to the hospital whenever she received the first dose of the covid vaccine. She has trouble walking long distances. She called the hospital before she went, and the hospital did not have any wheelchairs she could use. The hospital cleared everything out of the way so they could fit the most patients as possible in the building. She had trouble walking the day that she received her first dose of the covid vaccine. Someone wheeled her in and out using her own wheelchair. She cannot go to the grocery store. Using a wheelchair is the only way she could have in and out. She could walk from her wheelchair into the examination room, and then after she went right back into her wheelchair. She is glad that she called because she does not know what she would have done without a wheelchair. It is hard for her to go on, sometimes she just feels like crying. Her trouble walking does not feel 100 percent, but it has gotten better. She is anxious, depressed and nervous also. Before her breast cancer, she had chronic fatigue. She could volunteer at a clinic for a few hours a week. She had radiation, and that caused exacerbation of her chronic fatigue. Her doctor told her that for some people, chemotherapy will make chronic fatigue better and that chemotherapy could help her chronic fatigue. Before she got chronic fatigue syndrome, she had a lot of energy. She used to work in an ICU that had 15 patients, with ambulatory patients on the outside. She worked six days a week then she transferred to a hospital where she took care of patients after they had open heart surgery. She used to be a very high energy person. Her exhaustion has gotten better, because she can get up every other day and leave the house. She cannot stop doing life. It is difficult for her that she cannot go to the grocery store. After seven days, she could go out every other day. Whenever she went to a certain company, she almost fell. Her legs got weak and she lost coordination on Tuesday (06Apr2021). Since then, it has happened a little bit here and there. It is almost like she is not sure when it will happen. In an instance, she can be working in the house, and her left or right toe will get stuck. This happens to her occasionally after chemotherapy. She noticed that her blood pressure raised after receiving the first dose of the covid vaccine (Apr2021) and she takes medication (small dose of carvedilol) for hypertension. She takes her blood pressure medication every other day. Out of the past four days, her blood pressure has been elevated twice (Apr2021). If her blood pressure is elevated more than normal, her doctor prescribed for her to take an extra dose. Her blood pressure has not been elevated dramatically. She did take an extra dose of carvedilol because her blood pressure was within the scope of her blood pressure expertise. She went to the ER and the ER said her blood pressure was not bad (Apr2021), they put her in the waiting room and because she waited so long she just got up and left the ER. Since she is so tired and her Blood pressure is high, she has made an appointment with the doctor. She also stated that her blood pressure went up yesterday last night (18Apr2021), not right after getting the first dose. Last night at 6:00 PM, she took a nap and after she woke up took her blood pressure, she didn't feel anything in specific, she always takes her blood Pressure pill twice a day anyway. When she checked her pressure, it was 223/120 (Apr2021) and immediately took 2 Carvedilol 3.125mg and went to the ER, by the time she got there it was down significantly (Apr2021), but she is anxious and sat there and waited. They said they were going to do some blood work and an EKG but they left her there, so she decided to take a company home. Her Blood pressure has been up, she then went to sleep and after (Apr2021), it was 189/105, 183/105, and 165/95, she is a nervous wreck. She was ill for a long time, she had cancer twice, now she lives alone, she has been alone for all these weeks, her friends are here and there and come over. The Last 3 weeks she has been alone. She hired someone, but it was expensive. Now she feels hysterical (2021), after she saw her blood pressure, last night she was crying, and called the neighbor and they drove her right to the hospital then she was waiting in the ER for so long. She got her first shot on 30Mar2021 and she couldn't do anything in bed for 7 days, she is supposed to get the second shot tomorrow (20Apr2021) but doesn't want to be in bed again like that. She is anxious, depressed and nervous that began on 03Apr2021. During the week, she is distracted by the market. She has not been able to trade, because she does not trust her judgment right now. She did buy one this morning. Anxiety, depression and nervousness is not new to her which she has had this on and off for the past year. She has a lot going on. She needed to sell her two-story house and move to a one-story house that is easily assessable to healthcare and meals. She thinks this is disabling in face that she does not feel strong enough to make a decision. She cannot make a decision and she does not feel good enough too. Her anxiety, depression and nervousness was exacerbated by her terrible fatigue. She is experiencing awful symptoms. She went to the grocery store, and the stumbled and went into a company. She had to carry her milk and other items in slowly, and little by little. She thought this is awful, and she got into bed. She could not do anything. She mentioned that her illness is too much (2021). She was crying and she lives alone. The patient mentioned that the pain at the injection site began four hours after receiving the first dose of the covid vaccine. She received the vaccine at 10:00 AM then started getting really bad pain about 6:00 PM and then about 10:00PM or 11:00PM, it started to get unbearable. By 12:00AM (31Mar2021), the pain was so bad that she could not sleep because of the pain. She was in agony. She took took Tylenol and it did not touch her pain, but her pain got worse and worse, so she took three Tylenol tablets then they worked. She her friend and asked him to come over since she is afraid to take narcotics. She just laid there in bed and spent all night in agony. She tried a thing she put in the freezer and tried heat. She does not remember if either of those worked. The pain resolved about 2 days after. The patient declined safety report, saying that she is stressed and anxious (2021), she just wants to be transferred for her question. The reporter considered the events fatigue aggravated serious and 'anxiety, depression and nervousness was exacerbated by her terrible fatigue' with seriousness criterion of disability while the events blood pressure raised lower extremities weakness of and coordination impaired as medically significant. The outcome of the events fatigue aggravated recovering; as for the events blood pressure raised, 'anxiety, depression and nervousness was exacerbated by her terrible fatigue', lower extremities weakness of and coordination impaired were not recovered; while the event vaccination site pain was recovered on 01Apr2021 (reported as 2 days after). The outcome of the other events was unknown.; Sender's Comments: Based on the information provided, the events fatigue aggravated and 'anxiety, depression and nervousness was exacerbated by her terrible fatigue' with seriousness criterion of disability while the events blood pressure raised lower extremities weakness of and coordination impaired as serious (IME).Based on the plausible temporal association and product safety profile, the reported events are possibly related to the vaccine BNT162B2. administration. This case will be reassessed upon receipt of additional information.

March 10, 2021 I received my second dose of the Pfizer vaccine and the following day I experienced the predicted side effects of fever, chills, headache, fatigue and lack of appetite, which were all mild and I took Tylenol for the fever. The following day I was fine. After approximately two weeks I noticed there were subtle and unusual changes regarding my appetite, energy level an itchy rash on my back and a runny nose. I didn?t pay much attention to any of these as they weren?t debilitating symptoms, but very unique for me. Then I realized I needed to pay more attention to these symptoms as they were getting more significant, except for the fact I didn?t have a fever. Also my ears felt they were blocked. I thought perhaps because of the feeling of blocked ears I may be getting a sinus infection although I haven?t had one in years. I called the doctor?s office on April 5th and I was told to go to the Urgent Care, which I did. I was examined and given a prescription for a nasal spray, antihistamine and an antibiotic in case symptoms became more severe. It was also suggested that I may want to have a Covid test. I?m not used to taking any medications except for Trazodone, and was reluctant to take what was prescribed because if it was indeed a sinus infection it wasn?t in line with any I?d had years ago. I used the nasal spray for a few days and also the antihistamine. The headache got worse, and would move from one area of my head to another and also down the side of my face and neck. Tylenol didn?t help and Ibuprofen only helped now and again. The headache had a mind of its own. Warm compresses did help. I was in contact through the portal for recommendations from the medical staff.

Caller states it was very low, didn't think much of it, then it got worse.; she got a severe rash all over her body; she has her neck and back in flame red color with spots; This is a spontaneous report received from a contactable consumer (reporting on herself). A 76-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiry date was not reported), via an unspecified route of administration on 01Apr2021 14:00 as single dose for COVID-19 immunization. Medical history included blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medication(s) included oxytetracycline (TERRAMYCINE [OXYTETRACYCLINE]) taken for blood pressure measurement, start and stop date were not reported. patient got the first dose of the BNT162B2 on 01Apr2021 and she got a severe rash all over her body: she has her neck and back in flame red color with spots on her body and spots on her legs. She wants to know if she can take, Benadryl. Patient mentions that she was sorry the she got the shot and if she knew all the trouble she had to go through he would have never got it. She says that she will not going for the second shot after this. Aside this she mentioned that she was tired of being on the phone for 45 min while waiting for someone. And wanted to know if her insurance covered the vaccination or how does it worked. Patient states she has a bad knee and doesn't have it with her right now. Patient states she takes blood pressure pills but she feels okay. Patient states it was Terramycin, the generic. The outcome of the events she got a severe rash all over her body and she has her neck and back in flame red color with spots was not recovered and for event Caller states it was very low, didn't think much of it, then it got worse was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

she has a little bit of skin that is very dry; Pain under breastbone; Welts; lumps in her skin underneath; Swelling: lips, face swollen, arms, hands, fingers, left foot, left kneecap left thigh, feet swelled up like a balloon; Fingertips felt tingley; rash on her palm, a red circle; hand was hot and itchy; hand was hot and itchy; Tired and exhausted; toes feel puffy; urinary tract infection; not sleeping; Rash, painful; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Feb2021 (Lot number: EL9262; Expiration date: 31May2021) on the left arm at 0.3 mL, single for COVID-19 immunization. Medical history included AFib from 2009 and ongoing; allergies to antibiotics and Penicillin; shellfish allergy. No family medical history. Concomitant medications included nitrofurantoin (monohydrate/macrocrystals; Manufacturer: Alvogen Inc) from 17Mar2021 to 24Mar2021 for urinary tract infection; prednisolone from 10Apr2021 to 10Apr2021 for rash; chlorphenamine maleate (ANTIHISTAMIN) from 12Apr2021 for rash; and taking unspecified medications for a long time. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) on the left shoulder at 0.3ml single for COVID-19 immunization. Patient previously also had something else 10 years ago that didn't work, it was not a vaccination; took doxycycline hydrochloride (DOXYCILLIN) and amoxicillin that both experienced allergies. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). Stated that she had a urinary tract infection and was put on antibiotics for 7 days. Two days after starting the medication, she came down with a rash. The patient husband, who was a family physician had never seen a rash like that in his 40 years of practice. In the newspaper, there was a woman who got the vaccination, but not sure if it was Pfizer, and had a rash; the article had a picture of the rash the woman had, after the vaccine. Patient stated that her rash looked worse than the woman in the newspaper. The rash happened after the second vaccine, several weeks later, but after the antibiotics. Patient was allergic to a lot of antibiotics. She stated she may have this problem, the rash because she was allergic to a lot of antibiotics. When she got the rash, she went to the Urgent Care and was given a Prednisone shot and Prednisone pills. She got some relief taking the Prednisone. Patient weight as about 5' 4", she gained 8 pounds over the year while being stuck in her house. Patient stated she hasn't seen healthcare provider in a while, but she called him and he gave her the antibiotic prescription. Patient experienced the rash was painful on 17Mar2021 and she could feel when another one would start happening. Patient put ice on it to sop the pain and moved the ice packs around as it was reactive to pressure. Stated if there was anything tight, like underwear, or sitting on the couch, she would get welts and lumps, initially mentioned the top of her head. Reclarified itchy in later part of report. Patient got a prescription for her medication on 17Mar2021 and took it for 7 days, and then the rash happened a couple of days after she stopped the medication. As she had a little bit of skin that was very dry and she can see a line where the rash was. The rash pretty much gone, but not 100 per cent gone. Stated she went to the Urgent Care walk in, when she noticed the rash. Patient had two Covid tests, one was a blood test and one was a nose swab; reported both as negative. Stated she should have gone to the emergency room, but the doctor, in the Urgent are gave her a Prednisone shot. The only reason she didn't go because of the Covid, pandemic, so she went to the Urgent Care. The last medication that she took for the rash was an antihistamine on 12Apr2021, and last Prednisone pill was 10Apr2021; both pills were effective in treating the rash. Patient had a Zoom call with an allergist, and the doctor saw the rash with the help of a flashlight and altered the Prednisone dose. Patient had pain under breastbone that it was really bad and the day before she went, to the Urgent Care on the 28th or 29Mar2021, may in the early afternoon. Stated it was going on the whole time, intermittently, not constant in the last few weeks. She didn't know what was causing it as she had blood work to rule out gallbladder issues and that was not back to rule out a Shellfish allergy. Patient had welts and it all blends in from when she first noticed the rash a couple of days before she went to the Urgent Care. Answered as they were faded out, it was severe, then acute, then extreme for a week or more, and improved with steroids and then faded. Patient had lumps and it started two days before she went to the Urgent Care. Stated when she was sitting on the couch, reclarified, the cords of the pillow put pressure on the areas and it hurt and felt like welts. When she pushed on her skin, here were lumps in her skin underneath, and they hurt and were hot. Described the areas of the lump as buttocks, top of head, legs, arms, groin, underwear line, ear, ear lobe and face. Patient had swelling of lips, and they looked like she had Botox. Also reported additional swelling of arms, hands, fingers, arm from the wrist up to elbow, left foot, left kneecap, left thigh, and her feet swelled up like a balloon. It was better now. Patient had fingertips felt tingley. The palm of hand that patient got rashes in response to pressure and was trying to open a bottle. When she did she got a rash on her palm, a red circle and her hand was hot and itchy. Started as two days before she went to the Urgent Care. Stated she was tired and exhausted from not sleeping and the redness faded away and then it went away a couple of days ago with the help of the steroids. Patient had toes, feel puffy that described as the feeling when she goes to the dentist after she gets Novocain, the feeling. Patient had tired and exhausted. Stated she was tired the first few days until the rash peaked, as she was up all night for two nights icing the rash. Stated she was better but was not doing too much and didn't get out of the house, only when she had to. Lab data included on unspecified dates the blood work for urinary tract infection was negative; negative results for two Covid tests, one was a blood test and one was a nose swab; blood work to rule out gallbladder issues and that was not back to rule out a shellfish allergy. No events required a visit to emergency room or physician office, but patient went to Urgent Care and had a Telehealth appointment. The outcome of events "Rash; Welts; Swelling" was recovering, while of the other events was unknown. No follow-up attempts are needed. No further information is expected.

Throbbing pain arm of injection site. Muscle soreness inside of arm. Has continued for last two months.

injection site became red swollen and firm and warm within 24 hours of injection; injection site became red swollen and firm and warm within 24 hours of injection; injection site became red swollen and firm and warm within 24 hours of injection; chills; nausea; diarrhea; site remains red swollen and little soreness area below injection site.; This is a spontaneous report from a contactable consumer. A 76-year-old female patient (non-pregnant) received second dose of BNT162B2 (BNT162B2, PFIZER BIONTECH, COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 13:15 as 2nd dose, single for COVID-19 immunization. Historical vaccine of BNT162B2 was given as first dose in left arm (Lot number: EL3302) at 1.00pm on 20Jan2021 for COVID-19 Immunisation. COVID was not found prior vaccination. Medical history included hypertension. The patient's concomitant medications were not reported. Other medications were received in two weeks but not specified. The patient experienced injection site became red swollen and firm and warm within 24 hours of injection, chills, nausea, diarrhea and site remains red swollen and little soreness area below injection site. Treatment was not received. The outcome of the events was recovering for chills, nausea and diarrhea whereas not recovered for the other events.

Right knee pain; tenderness; swelling; Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), on 26Jan2021 at 12:00 (at the age of 76-years-old) at 1st dose, single administered in left arm for COVID-19 immunisation. Medical history included allergies. The patient was not pregnant. No COVID prior vaccination and no COVID tested post vaccination. Concomitant medications included calcium, tocopherol (MEMORALL), cetirizine, KETO, unspecified (all reported as other medications in two weeks). The patient previously took ampicillin and experienced allergies. No other vaccine received in four weeks. The patient experienced right knee pain, tenderness, swelling, continued. Pain at injection site lasting 24 hours. The events occurred on 30Jan2021 at 8:00. No treatment was received for the events. The patient had recovered from pain at injection site on 31Jan2021 at 08:00, had not recovered from the other events.

vaccination site red; vaccination site swollen; vaccination site hot; vaccination site itchy; This is a spontaneous report from a contactable consumer. This female consumer reported for herself that: A 76-year-old female patient received dose bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number: E19264 but it could be EL9264, and expiration date were not reported) via a unspecified route of administration in left arm, on 05Feb2021 at 14:30PM (at the age of 76-year-old) as single dose for COVID-19 immunization. The patient was not administered an additional vaccine on same date of the Pfizer vaccine. The concomitant medications included a Proto-nix used for Barrett's oesophagus, Celexa used for Anxiety, Rosuvastatin used for Blood cholesterol increased, and baby Aspirin for a while. On 14Feb2021 at 9PM the patient had a huge reaction at the injection site where it was red, swollen, hot, and itchy. The reaction is in the left arm and that is where she received the injection. It is still hot and swollen and red. She has no fever. On 16Feb2021 for the first time she took a little Tylenol. She is due in 10 days for the next dose. The outcome of event is not recovered. Follow-up (16Feb2021): This is a follow-up spontaneous report from a contactable consumer. This 76-year-old consumer reported a significant information regarding suspect drug and events.

Dizzy,Fever, Disoriented, (expected: arm soreness, heat, swelling administered frozen pea bag) rash on forearms,, not hives, passed out for 9 hours I thought I would just relax with my frozen peas and watch tv. 9 hours later, I was slumped on the couch, tv had not been turned on , I was fully dressed including shoes, no blanket or pillow, very cold all the lights that I had turned on were still on and it was 5:10 in the am I had not brushed my teeth or taken evening medication. I had warmed left overs in the oven thinking I might just be hungry. Oven was off but oven door was open food was uneaten except for a couple of bites. I live alone. I still work and manage everything on my own.

Soreness under her arm unsure if muscle or lymph nodes; Pain under the arm, under the injection site in which it was a soreness; Aching in arm; Achy; This is a spontaneous report from a contactable consumer. A 76-year-old female consumer (patient) reported that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318; Expiration Date: May2021) via an unspecified route of administration, administered in right arm on 04Feb2021 at 10:30 as first dose,single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No Prior Vaccinations within 4 weeks. On 04Feb2021, the patient experienced after is that she felt a little achy and 04Feb2021 at 8:00 pm that evening her arm was aching, patient took an Ibuprofen and had no problem afterward, On 05Feb2021, the day after patient mentioned had pain under the arm, under the injection site in which it was a soreness which had no lump. She cannot discern whether it was a lymph node or muscle, but is leaning more into it being a muscle because patient could feel a pulling sensation when patient raises her arm at the shoulder. Patient was asking if these are common side effects and for how long do these usually last. On 06Feb2021 soreness under her arm, unsure if muscle or lymph nodes. The outcome of the events achy, pain under the arm, under the injection site in which it was a soreness were unknown, soreness under her arm was recovering and aching in arm was recovered on 04Feb2021. Follow-up attempts are completed. No further information is expected.

it shows no sign of going away, infact it seems to be worsening; Started 1-2 days following 2nd Pfizer Covid vaccine/more spread and violent eruptions all over; Body rash, itching. Started 1-2 days following 2nd Pfizer Covid vaccine/mMy skin continues to erupt from head to toe, both painful and itching; acute skin reaction, huge patches of bright red, and many areas swollen; acute skin reaction, huge patches of bright red, and many areas swollen; acute skin reaction, huge patches of bright red, and many areas swollen; My skin continues to erupt from head to toe, both painful and itching; This is a spontaneous report from contactable consumer(patient). A 76-year-old non-pregnant female patient received second dose on BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number EN6204) on 12Mar2021 via an unspecified route of administration in the left arm at single dose for COVID-19 immunisation. Medical history included Diabetes Type II controlled, hypoparathyroidism and bi-polar. Concomitant medications included CALCITRIOL (calcitrol [calcitriol]), CALCIUM (calcium), AMITRIPTYLINE HYDROCHLORIDE (amitriptyline) and LITHIUM (lithium) (medication in two weeks). No other vaccine in four weeks. The patient had no allergies. The patient previously took first dose of BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number EN6200) for on 19Feb2021 10:30 via an unspecified route of administration in left arm at SINGLE DOSE for COVID-19 Immunization. It was reported that, on 07Apr2021 adverse reaction to Pfizer covid vaccine: Body rash, itching. Started 1-2 days following 2nd Pfizer Covid vaccine on 12Mar2021. Rash has persisted reappearing over most of body, legs, hips, stomach, back, rib cage, feet hands, etc. Seems to flare up in areas, subsided then reappeared in another area. OTC antihistamine was not effective. Rash was continued nearly 4 weeks following 2nd vaccine and does not appear to be going away. Very distressing as rash persists. Patient has been to her primary care doctor and a dermatologist who had no idea what was causing her acute skin reaction to the Pfizer vaccine. Patient was quickly approaching two months with a violent skin reaction, huge patches of bright red and many areas swollen. Patient's skin continued to erupt from head to toe, both painful and itching. When red patches broke out then slowly recede more red patches broke out. Patient has never had such an allergic reaction and it showed no sign of going away, in fact it seems to be worsening. There was no information available as to what patient have been poisoned with, was there an antidote, would it ever go away. Every day patient awakened with more spread and violent eruptions all over her body. Patient said you need to respond, and you need to tell her what was wrong. This was no less than frightening and depressing. A high dose of antihistamine and topical steroid did nothing to control her acute reaction. The patient was treated with antihistamines and topical steroids. No COVID prior vaccination. Patient has not tested COVID post vaccination. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.

Erythromelalgia; 3/19/2021 Patient is a 76-year-old female who presents to the emergency department for evaluation of a pruritic rash. Is been present for just over 1 month. She relates that began after receiving her second Covid vaccination. She denies any new exposures medicines foods cleaning items or hygiene supplies. She denies any systemic symptoms. No airway symptoms. Physical exam significant for dry erythematous rash. Is suggestive of eczema. His primary to the right hand in the palm. It seems to spare the dorsum of the hand. There is diffuse swelling. No fissures or lesions. No evidence of secondary infection.

She bled a little bit; A 'black and blue mark on the arm (as big as a tangerine, and is still there)'; When she vaccination provider put the needle in, it really hurt/soreness; Her arm ached; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer reported for herself that . A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Right on 24Jan2021 13:00 as 1st dose, single for covid-19 immunisation. Medical history included for her belly. Concomitant medications included fish oil (OMEGA XL) (Has been taking for years) ongoing and glycopyrrolate [glycopyrronium bromide] taken for her belly, (Once a day) ongoing. On 24Jan2021 the patient experienced Black and Blue mark on arm, when she vaccination provider put the needle in, it really hurt/soreness and her arm ached. On an unknown date the patient experienced she bled a little bit. The patient stated that She got the vaccine on as confirmed Sunday 24Jan2021 and later that day her arm ached. She has heard a lot of people had ache, arm ache after getting the vaccine, but no specific patient details provided.She looked at her arm and she had a black and blue mark as big as a tangerine. She is not too happy that happened. She has to get the second dose of the vaccine 14Feb2021. She is not sure if she wants to get the second one. If this occurred with the first one. She also hurt with getting the vaccine. She is not sure where the needle was placed when getting the vaccine, but it hurt, and she bled a little bit. The nurse had to place a Band-Aid on it. Her arm is still black and blue. She noticed the black and blue mark on the same date she got the vaccine. It was later that day in the evening. She does not know the exact time. The black and blue mark is on her right arm. She noticed her arm ache shortly after she got the shot. It was a few hours after getting the vaccine, but she does not know what time. She stated this seems to be a complaint of a lot of other people, but no other specific patient details provided. It is her right arm that aches. She stated she is wondering if she needs to be concerned about these events. Should she be concerned about what her arm looks like. She is still having soreness. Therapeutic measures were taken as a result of a 'black and blue mark on the arm. The outcome for the events black and blue mark on the arm (as big as a tangerine, and is still there) and her arm ached was recovering. The outcome for the event when she vaccination provider put the needle in, it really hurt/soreness was not recovered. The outcome for the event she bled a little bit was unknown. Follow-up attempts are completed. No further information is expected.

It was vaccine I noticed my arm turning red at the injection site and it was hard. It started to travel up and down my arm as one large area. It was itchy and warm. It got larger over the course of two days and then it started to recede. I iced it and it helped a little. Benadryl did not help. I got the second shot in the same arm and it did not spread but it did get a little red. I also got the shingles about two weeks out from the vaccine. I have had the shingles before and I knew what it was so I took the medication and it cleared up quickly.

Rash small red spots on face 4 days after second shot.; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received BNT162B2(PFIZER BIONTECH mRNA COVID-19 mRNA VACCINE; Lot no. EN6206), 2nd dose single on the right arm via an unspecified route of administration on 09Mar2021 as single dose for COVID-19 vaccination. Medical history included Arthritis and Hypothyroidism. Concomitant medication included bupropion (MANUFACTURER UNKNOWN), Metoporaltrx (MANUFACTURE UNKNOWN) Levothyroxine (MANUFACTURER UNKNOWN), Estradiol (MANUFACTURER UNKNOWN). The patient was allergic to Penicillin, Demerol. It was unknown whether patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not enrolled in clinical trial. The patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. On 12Mar2021 at 10:00, the patient experienced rash small red spots on face 4 days after second shot. It is unknown whether the patient received any treatment for the event. The clinical outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Large oval patch (plaque?) rough around the border, smooth and paler color inside. 1" long. Center of my back (I have a photo) I just noticed it yesterday. No treatments.

Hives; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in arm right on 13Mar2021 11:30 (Batch/Lot Number: Ew6205, expiration date: not reported) as second dose, single for covid-19 immunisation (at the age of 76-years and was not pregnant). The patient medical history included known allergies (but have not had any of them). Concomitant medication(s) included apixaban (ELIQUIS), metoprolol succinate taken for an unspecified indication, start and stop date were not reported and multivitamin (all as other medications in two weeks). No other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. Previously, the patient received BNT162B2 via an unspecified route of administration, administered in arm right on 20Feb2021 11:30 (Batch/Lot Number: Em9810, expiration date: not reported) as first dose, single for covid-19 immunisation. On 15Mar2021 05:00, the patient experienced hives. No treatment received for the adverse event. Outcome for the event was not recovered. No follow-up attempts are possible. No further information is expected.

This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265), via an unspecified route of administration on 30Jan2021 09:30 (at the age of 76-years) as 2nd dose, single dose in left buttocks for covid-19 immunization. Medical history included: slight high blood pressure and unspecified allergies. The patient didnot receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included carvedilol 12.5 mg, vitamin d [vitamin d nos], pantoprazole sodium. The patient received first dose of BNT162B2 (lot number: EL1283) via an unspecified route of administration on 09Jan2021 at 10:30 as 1st dose, single dose in Left buttocks for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 31Jan2021 at 05:00, the patient experienced fever 102.6, chills and aches, headache, soreness at site of injection with a 3 inch red circle. The patient underwent lab tests and procedures which included body temperature: 102.6 on 31Jan2021. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

weak; does not feel well; Stomach is upset 24/7; TSH is off; skin so itchy; dry heaves; nauseated/Nausea; sore arm; I don't like the way I'm feeling; This is a spontaneous report from a contactable consumer (the patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0773) via an unspecified route of administration in left upper arm on 04May2021 11:00 at age of 76-year-old at single dose for COVID-19 immunisation. Doctor wanted her to get it. Caller said that her doctor told her she wouldn't make it if she got COVID. Her heart couldn't pump very well and was very weak. Other medical history included a lot of allergies (They made her sit in a recliner for 30 minutes) and thyroid disorder. No further details provided by the caller regarding her thyroid condition. Caller did not think there were any other medical conditions that she had that would be relevant as she was pretty darn healthy. Family medical history relevant to AE: Not that she knows of. Daughter had the shot and was sick for 2 days. She had the Pfizer. No vaccine administered on same date of the Pfizer suspect. No history of all previous immunization with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks). Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid from an unspecified start date for 20 years and ongoing. Got the shot 04May2021. Dry heaves on 04May2021: Didn't really throw up, but she had them all day. Still has them but not as bad. Nausea/ nauseated on 04May2021: It was actually kind of steady. Caller was able to eat and drink, not that she wanted to. She did not know what to do with herself. She was eating and drinking. She took TUMS [CALCIUM CARBONATE] and always had a cast iron stomach. Skin is so itchy on 04May2021: Skin started itching right away, that evening that she got the shot. She even used a back scratcher. It was all over and still felt the same. Treatment: Had taken diphenhydramine hydrochloride (BENADRYL) maybe once or twice and when she went to bed. She didn't take it steady. She did not take the TUMS steady either. Yesterday, she felt better, and currently felt worse again. Had a little more energy and was feeling good. Sore arm on 04May2021: Was sore right away, after the shot. It was still sore but it was better. It was not red or anything. Treatment: Took 1/4 of a paracetamol (TYLENOL), 325mg, so it was 12 or something. Weak on an unspecified date and did not feel well on an unspecified date. Her blood pressure was good and she has no fever. She also stated her stomach was upset 24/7. She didn't like the way she was feeling after the first dose (May2021). She just wish this would go away. She didn't feel good. 10 days was a long time to have a reaction. Tests: Recently had blood work and everything was normal. Even her thyroid stimulating hormone (TSH) which she got tested for every month is fine. It was off but currently was regular. The event did not require a visit to emergency room or physician office. Her next shot was on 25May2021 and was scared to get it. The patient asked what would happen if she did get the second dose. The outcome of events "skin so itchy", "nauseated/nausea" was not recovered, of events "dry heaves", "sore arm" was recovering, of "TSH is off" was recovered, of other events was unknown.

hives go from face to chest both sides of body; This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9261 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 15Feb2021 12:00 AM, as single dose for COVID-19 immunization. Medical history included sjogren's syndrome, Afib regulated and PMR. No known allergies were reported. The patient did not take other medications in two weeks. The patient did not receive other vaccine in four weeks. The patient did not had covid prior vaccination and was not tested for covid post vaccination. On 28Feb2021, 12:00 AM, the patient experienced hives which went from face to chest both sides of body. It was reported that, sunday (28Feb2021) hives go from face to chest both sides of body, never had hives before. No change in medications, food, or product use. The patient received treatment with benadryl. The outcome of the event was reported as not recovered. No follow-up attempts are possible. No further information is expected.

Outbreak, looked like hives, on her torso and stomach area, after the first vaccine:; Chills, after first and second vaccine; Injection site sore after first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6204, Expiration date was not reported), via an unspecified route of administration on 03Mar2021 14:00 as 1st dose, single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as none. On 03Mar2021, the patient experienced outbreak, looked like hives, on her torso and stomach area, with sequelae after the first dose, chills after first and second vaccine, injection site sore after first and second vaccine, Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine (Patient visited office). she would like to know about percentages in age groups who have experienced any numbness and tingling, and if there are any correlation with developing blood clots of this, and also, she wanted to know if she needs further medical attention and to prevent a serious outcome. The outcome of the event was recovered for urticaria on 21Mar2021, the outcome of chills was unknown. Vaccination site pain, Hypoaesthesia Paraesthesia 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 female patient received bnt162b2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20May2021 as 1 st dose single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient is a 76-year-old female patient who received her 1st dose of the COVID Vaccine a week ago today, 20May2021. She mentioned that she experienced basically every side effect on the fact sheet except nausea. She had fever, chills, injection site swelling. injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and a general feeling of unwellness. She mentioned that this lasted for 5 days and all came in gradually and not all at once. She is better now as of calling. She was asking if this is to be expected with the 2nd dose as well. The patient enquired whether using a heating pad would affect the effectiveness of the vaccine. The outcome of the events fever, chills, injection site swelling, injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and general feeling of unwellness were recovered. Information on the lot/batch number has been requested.

and pain down to the foot, ankle and calf areas, after second vaccine; Headache: left side and right side of head, frontal area, feels like it is travelling from her arm to her head, after the second vaccine; Face spasms on the left side of face; after the second vaccine and it was worsened; Chills, after first and second vaccine; Injection site sore after first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips after first and second dose; Left side of the body had tingling, numbness; This is a spontaneous report from female contactable consumer (Patient). A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection, lot number was not reported) via unspecified route of administration, administered in left arm on 31Mar2021 at 14:00 (at the age of 76-years-old) as single dose for COVID-19 immunization. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number: EN6204) via unspecified route of administration in left arm on 03Mar2021 at 14:00 as single dose for COVID-19 immunization and on same day patient experienced outbreak, looked like hives, on her torso and stomach area, chills, injection site sore (which subsided after 18-days), arm was numb, tingley and painful from the shoulder to the fingertips. Medical History and concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect. No vaccinations within 4 weeks prior vaccinations. On 31Mar2021 (same day of 2nd dose of vaccination), patient experienced face spasms on the left side of face, after the second vaccine which was intermittent in the evening, headache: left side and right side of head, frontal area, feels like it is travelling from her arm to her head and left side of the body had tingling, numbness and pain down to the foot, ankle and calf areas, along with the events of first dose, which were worsened after second dose that included chills and injection site sore (which subsided 18-days after first dose), arm was numb, tingley and painful from the shoulder to the fingertips. Patient required to visit physician office, primary care doctor for her numbness, tingling and pain. Reporter stated she was very interested in percentages in age groups who have experienced any numbness and tingling and asked if there are any correlation with developing blood clots and would like the information to see if she needs further medical attention and to prevent a serious outcome and discuss it with her doctor and agrees to be transferred to Medical Information. The outcome of all the events was not recovered. No follow-up attempts are needed. No further information is expected.

Itch; she broke out in spots that are red and raised up; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 21Jan2021 16:00 (Batch/Lot Number: EL3246) as 1ST DOSE, SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Right on 11Feb2021 16:00 (Batch/Lot Number: EM9810) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation (COVID Prevention). Medical history included Allergic to Shellfish. The patient's concomitant medications were not reported. It was reported that on 22Jan2021 patient broke out in spots that are red and raised up. Reporter was calling about his wife. Reporter states that his wife broke out just a little with the first dose of the product, and with the second shot she broke out in 5 or 6 spots on her belly that are maybe an inch around, and raised up, like pumped up, and her skin is turning red. Reporter clarified the suspect product as the Pfizer COVID Vaccine. Reporter was wondering if this was a normal reaction. Reporter informed that the patient was 76 after the first dose of the product, and 77 when she received the second dose. It was also reported that the patient got her first dose of the product on 21Jan2021, and the spots appeared the next day. Caller reports that they thought they got bed bugs because the spots look like little bites, like welts that stay for two or three days and then they go down. Caller informs that the patient got the second dose on 11Feb2021 and the spots appeared again the day after the injection, and caller confirms they are ongoing and persisting. reporter was wondering how long the spots will last. Caller reports the patient saw a dermatologist and was given a cream. Caller also stated that patient has been using rubbing alcohol on the spots to help the itch. Reporter also stated that his brother, sister and sister-in-law have all received the vaccine and no one else has broken out so far. Patient not having previous doses of the COVID-19 vaccine prior to 21Jan2021. Outcome of the event Itch was unknown. Outcome of the other event was not recovered. No follow up attempts are possible. No further information is expected.

pt says that she has a tremendous amount of body and muscles aches with extreme fatigue. She already had numbness and tingling throughout her entire body (including lips and face) but became much more severe in April. In the last couple of weeks she has developed rashes on various parts of her body. Pt had appt w/ PCP. She had blood work that was negative and was referred to a Rheumatologist. On 6/3/21 she went to another doctor. She had more blood work. Pt is waiting on results. She also went to see another doctor. She had more blood work and waiting on these results. She has an appt Neurologist. She also had swelling with her gums for a couple of days. She has a very foggy feeling like she is spaced out. She feels like her vision has been impaired. She still feels bad most days saying the her symptoms come and go and she has felt this way since taking the vaccine. She has headache that come and go for the last couple of weeks.

Burning sensation all over her skin; Very tired; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch no: EN6205, NDC number; expiration date: unknown), via unspecified route in the deltoid left on 26Feb2021 at 15:00 as single dose for COVID-19 immunization. The patient medical history included blood pressure. Concomitant medication included atenolol taken for blood pressure as 25 mg, amlodipine as 2.5 mg and doxazosin as 1 mg, both taken for blood pressure measurement. Patient previously had first dose of BNT162b2 (Lot: EL9264, NDC; expiration date: unknown) on 05Feb2021 for COVID-19 immunization. On 27Feb2021, in the morning when she woke up, she had burning sensation all over her skin. She rested all day on the 27Feb2021 and then Sunday 28Feb2021 she was just a little tired but there was no more of the burning sensation. She confirmed the tiredness started on Saturday 27Feb2021. She usually works on Saturday, but she could not work because she was too tired. By Sunday 28Feb2021 she was better. She thought she rested and continued to rest because she was still a little tired. She recovered by Monday and she went back to work. The patient did not receive any treatment for the events. The clinical outcome for the event burning sensation was recovered on 28Feb2021 and very tired was recovered on 01Mar2021. No follow-up attempts are possible. No further information is expected.

shingles with blisters on left side of neck and left side of head and face down to the front of my neck. I was treated with Valtrex 3 times and am suffering with the nerve endings itching. Very unpleasant.

She has been experiencing hair loss for a while; had a little bit of muscle pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via intramuscular route of administration in left arm/shoulder on 02Feb2021 (at the age of 76 years old) in the morning as 1st dose, single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266) via intramuscular route of administration in left arm/shoulder on 23Feb2021 (at the age of 76 years old) in the morning as 2nd dose, single dose both for COVID-19 immunisation. Medical history included psoriasis on legs. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL S) 200mg tablet by mouth once daily taken for psoriasis from 29Mar2021. The patient did not receive any additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the first administration date of suspect vaccine. The patient experienced she has been experiencing hair loss for a while on 07Apr2021 and had a little bit of muscle pain on an unspecified date in 2021. It was reported as, patient received both doses of the Pfizer Covid 19 vaccine in February. She has been experiencing hair loss for a while. Her dermatologist told her it was due to the vaccine. She enquired whether this happened to anyone else or was there other reports also. She was getting treatment for psoriasis and thought it was due to it. She contacted the FDA and was told it would take 120 days for it to drop to a half dose in her system. She asked about contacting CDC to report it. She was so upset that this happened to her. The patient hair loss was almost gone now, her daughter said she had fuzzies instead of bald spots. She just had bloodwork a few weeks ago, and had regular meds she takes, but has been taking those for a couple years but they don't make a difference with the shot, she doesn't believe. Patient has psoriasis on legs and was taking a new drug her dermatologist provided and she called the FDA about this med and they said it could cause hair loss but probably not, her doctor said it was not the cause of it. Drug was Plaquenil, but she was taking the generic for that, she was taking hydroxychloroquine 200mg tablet by mouth once daily, she started, she believes 29Mar2021 for psoriasis on legs. She stopped it as soon as her hair was falling out, as she thought it was that originally, but her dermatologist said it was not, it was from the shot. Patient did not visit physician office but it was panic, she was crying for 2 weeks, her daughter informed there was nothing to do, it will just fall out. Patient informed that when she got the shots, she didn't have any kind of reaction, just the second, she had a little bit of muscle pain, but overnight it went away. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date. Outcome of the event hair loss was recovering and for muscle pain recovered on an unspecified date in 2021. Follow up attempts are needed. Further information has been requested.

She had high Blood pressure yesterday; Second dose administered on the Left Arm, her arm did hurt a little on 06Feb2021, the day she got this dose; started getting hungry; she was 127lbs, probably because of the swelling, but she is usually 119lbs or 118lbs; swelling under her eyes/eyes started getting swollen; face was swollen; Eye infection; face felt tight; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot: EM9810; NDC number: Not Provided Expiry Date: Unknown) via an unspecified route of administration on the left arm on 06Feb2021 at 8:31AM (at the age of 76 years), as a 2nd dose, single dose for COVID-19 immunization. The patient medical history included disc protruding (diagnosed before the covid vaccine in Jun2020 or around that, she recalls having several months of MRI's in 2020) and high blood pressure. The patient's concomitant medications included Epidural Shot (Verbatim) for Protruding Disc Patient on 27Jan2021 (she had to go to the doctor in the clinic and get epidural shot in the back at the disc thats protruding). Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot: EL3249; NDC number: Not Provided, Expiry Date: Unknown) via an unspecified route of administration on the left arm on 16Jan2021 at 12 PM (noon) as 1st dose, single dose (at the age of 76 years) for COVID-19 immunization. Clinical course: She took second dose of Pfizer Covid Vaccine on 06Feb2021, though she had no reaction initially. A week later from vaccination on Feb2021, she then began to notice her eyes started getting swollen couple days after, she then felt like her eyes felt like they were closing, then she saw her whole face was swelling, it looks like she had Chipmunk cheeks. She went to the doctor hoping it would go away, she was prescribed Benadryl and a decongestant as treatment. She takes Benadryl three times a day and the decongestant in the morning and her face is still swollen. It started with the eyes and the bag under the eyes, that was the first thing she noticed. She laughs and though she initially had an eye infection. She just wants to know if there is any other reports of this happening, or how to get rid of it, this has been there since she got her second dose on the 06Feb2021 since like 10Feb2021. After the second vaccine on 06Feb2021 around that time an hour later, she was on the way home and started getting hungry, she thought that was a symptom as well as her arm hurt a bit. She was starving till Monday got up 2AM, 6AM ate all day Sunday and Monday ate all day, as reported "all she knows is she was craving a crab sandwich." Her Eyes swelling started a couple days later and the Face swelling was either the second week or same time, she just recalls looking at the eyes. She recalls telling her son her face felt tight in Feb2021. At the doctors appointment she was 127lbs, probably because of the swelling, but she is usually 119lbs or 118lbs, she is a small girl. The Appointment with the doctor was yesterday (15Mar2021), they prescribed Benadryl. Patient clarified that she was not Prescribed Zyrtec, it was a decongestant but she does not know the name of it. The Druggist however told her she could take another medication also. As reported "The eye swelling and face swelling, at the moment she look like she been drunk, her face is plentiful, she is still swollen, her lids are not bad, but it is ongoing, it has gotten worse because prior she didnt even know it was there and its showing more now. She asked son if he thought she was swollen because she feels tight, over the weekend her face being swollen was noticeable, she is noticing people are pointing it out now." She adds her arm did not hurt with first dose. Second dose administered on the Left Arm, her arm did hurt a little on 06Feb2021, the day she got this dose and the next day (07Feb2021). She thought initially that she didn't have any side effects. She had High blood pressure yesterday (15Mar2021), but that usually goes up and down for her and nothing new. It was reported that, a week later, patient experienced swelling under her eyes, face was swollen, eye infection and face felt tight on Feb2021; hunger and vaccination site pain on 06Feb2021 (reported as the day she got this dose); hypertension on 15Mar2021 (reported as yesterday). Patient would like to know if swelling of the face is a reported side effect from the covid vaccine, how long her side effects from the covid vaccine will last and asking for suggestions on how to get rid of the side effects from the covid vaccine. The outcome of event vaccination site pain was recovered in Feb2021 (duration of event was 2 days), swelling under her eyes, face was swollen was not recovered while outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.

get more blisters in her mouth; progressed to two blisters, one on each arm; This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported), at the age of 76-years-old as 1st dose, single; and dose 2 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. Medical history included mucous membrane pemphigus. Historical vaccines included shingles vaccine and pneumonia vaccine on Nov2020 and flu shot on Dec2020; all taken at the age of 76-years-old. The patient's concomitant medications were not reported. The patient received her first shingles vaccine in November as well as pneumonia vaccine. She received Flu shot in December. She waited a month after second dose of product before receiving second dose of Shingrex. She knows vaccines can cause flare up of her historical condition of mucous membrane pemphigus and has been controlled with very low dose dapsone and under control for two years. She stated she started to get more blisters in her mouth and was prescribed dexamethasone wash. Then progressed to two blisters, one on each arm. Referred to her dermatologist who indicated she has seen the condition progress/ in those whose who are fully vaccinated. The outcome of the events was unknown. Information on the lot/batch number has been requested.

I was very tired and I experienced Chills like I've never felt before and I had a high fever. After I was admitted in the hospital I was diagnosed with cellulitis.

redness of injection site; arm aches; itching around injection site; Swelling around injection site; This is a spontaneous report from a contactable consumer reporting for herself. A non-pregnant 76-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in right arm on 10Mar2021 13:30, at 76 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included hypertension, kidney disease, stroke survivor, breast cancer survivor and allergy to nichel and to shrimp, all from an unknown date. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in right arm on 17Feb2021 13:30 , at 76 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Concomitant medications included allopurinol, metoprolol, atorvastatin, lisinopril and rivaroxaban (XAREL), all taken for an unspecified indication, since an unspecified date. The patient didn't receive any other vaccine in the previous 4 weeks. She was not diagnosed with COVID-19 prior to vaccination and was not tested positive for COVID-19 post vaccination. On 11Mar2021 08:00 the patient experienced redness of injection site, arm aches, itching around injection site and swelling around injection site. No treatment was received for the events. At the time of the report the events had not resolved yet. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

SOB,Rash,4/14 anaphylactic shock admitted to Er remained overnight for observation, 5/9 rash returned after prednisone ER , 6/10 dermatolgist Dr rash returned. Took scrapping of skin, came back as Grover,s Disease.

About a couple weeks after my second dose of the vaccine I started to have extreme itching on my scalp. I did not see anything at first and then another week later I saw a red irritated area. Then a couple days later I saw a white plaque like material. So then I saw a dermatologist and he said it was plaque psoriasis. He injected some medication behind my left ear (I do not remember what) and gave me a medicated shampoo which was a prescription. It is called ketoconazole shampoo 2% for topical application only. I continue to use it because the plaque is still there, the itching continues as well. I itch a lot during the night and I will do a follow up with a DR.

Red Spot on Cheek; got the injection on her arm, it is red around the injection site and then went down her arm and back up; broke out in little red bumps on her chest and her arms, and it was the same kind of redness where she had the shot injection; also on her legs/rash on chest spreading down arm; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP6955, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in right arm on 28Mar2021 at 11:15 hours as 2nd dose, single dose (at the age of 76-years-old) for covid-19 immunisation. Patient's had no medical history (including any illness at time of vaccination) and relevant family medical history. Concomitant medication(s) included vitamins (occasionally takes vitamins) taken for an unspecified indication, start and stop date were not reported. Patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6205, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in right arm on 07Mar2021 as 1st dose, single dose (at the age of 76-years-old) for covid-19 immunisation. Patient had no prior vaccinations (within 4 weeks). Patient stated that initially after first dose, there was no redness at injection site. On 05Apr2021, patient now indicates a big red circle/red around the injection site, patient had it since it just popped up 2 weeks after the shot. Patient stated it was red around the injection site and then went down her arm and back up and it was worsened and then she broke out in little red bumps on her chest and spreading down arm/rash on chest spreading down arm, and it was the same kind of redness where she had the shot injection. Patient stated she also had a few on her legs. Patient stated she was not sure if it was an allergic reaction or how to treat it. Patient stated the redness was on her arm down to her elbow, it was pink and red and warm and then it went away, and now it was just red at the injection site. Patient was trying sensitive soap bout expensive sensitive soap to try and dry them up as treatment as it was a two month delay to see dermatologist. Patient also reports on cheek starting last week. On 26May2021, patient had red spot on cheeks. The outcome for broke out in little red bumps on her chest and her arms, and it was the same kind of redness where she had the shot injection; also on her legs/rash on chest spreading down arm in 2021 was recovered and for rest of the events was not recovered.

Breakout rash around neck, shoulders, chest, arms and tops of legs. None under arms or breasts. Has had rash since 6/7/21. Some raised bumps within rash as well, resembled insect bites. Some of the rash looked like insect bites, other areas skin broken, looks like skin scraped. Skin has peeled off on those areas. Had got bladder infection since then as well. Had blood in urine and received antibiotic (6/9/2021). Since then bladder infection has cleared. But patient has had a cough since then (about 5 days into breaking out). Has also had a slight headache.

Inability to sleep night after second dose, itching of (pre-existent) eczema and several new hives on shoulder, breast, legs.; Itching of (pre-existent) eczema; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208), via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 (at the age of 76-years-old), as a single dose for COVID-19 immunisation. Medical history included eczema, taste disorder, gastro-intestinal reflux, arthritis, drug allergy (sulfa drugs) and breast cancer (small lump). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the left arm on 23Feb2021 at 10:00, as a single dose for COVID-19 immunisation. Concomitant medications included losartan (MANUFACTURER UNKOWN), pantoprazole (MANUFACTURER UNKOWN), rosuvastatin (MANUFACTURER UNKOWN) and sucralfate (MANUFACTURER UNKOWN) all for an unknown indication from an unspecified date and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had not tested positive for COVID-19 since the vaccination. On 18Mar2021 at 12:00, the patient experienced inability to sleep night after second dose, itching of (pre-existent) eczema and several new hives on shoulder, breast, legs. The patient self-administered EUCRISA and hydrocortisone was given as treatment for the events. The clinical outcomes of the events insomnia and itching were recovering. No follow-up attempts are possible. No further information is expected.

weight is too much; she developed a rash on her body/blotches/rash on chest, small amount on arms, and a couple on legs; face very red; This is a spontaneous report from a contactable consumer(patient). A 76-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9264, Expiry date: May2021), via an unspecified route of administration on 31Jan2021 at 15:30 into left upper arm as a 1st dose single dose for COVID-19 immunization at hospital. The patient had an allergy to penicillin. No other vaccine given the same day or 4 weeks prior. No problems with vaccines in past. On 04Feb2021, patient developed a rash on her body, blotches/rash on chest, small amount on arms, and a couple on legs and face very red. On an unspecified date, patient experienced shrinking, weight is too much. She got the first Covid-19 shot at (hospital) this past Sunday. Went to take a shower today and her face was very red so she looked at her chest and there were blotches that looked like a rash. Had a small amount on her arms, but not at the injection site. Also had a couple of blotches on the legs. Had called the doctors at (hospital name) and had a virtual visit and was told to take Benadryl. This was 4 days after and wants to know if we have found out any information about her. She asks should she get the second dose in the same arm. Mentions she and her husband did take a COVID test because her husband had a belly ache so they wanted to make sure it wasn't that or something that he ate. They suspected it was something he ate and it was, they both were negative. Clarifies this was before getting the Covid-19 shot. Later mentions she has an allergy to penicillin and was not sure if that is related. Had a reaction as a child and has not taken it since. The patient was not visited to emergency room for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date Jan2021.The outcome of the events was unknown for overweight and recovering for other events Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.

chills; the glands in her neck, under her chin were swollen and hurt a little; below knee and feet and toes are crampy; Her mouth has been dry and drinking more water; Her body just feels achy; injection site is sore; does not feel well; her tingling in her legs from the knee to the toe; the glands in her neck, under her chin were swollen and hurt a little; sore arm; weight is a little low at the moment; This is a spontaneous report from a contactable consumer reporting for herself. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EM9810; Expiration date: not reported), dose 1 via an unspecified route of administration, administered in left arm (in the muscle in upper arm) on 03Feb2021 (at the age of 76-years-old) as first dose, single for prevention. The patient's medical history and concomitant medications was none. After receiving the first dose, in the afternoon the patient started experiencing side effects of chills, pain in the injection site, the glands in her neck, under her chin were swollen and hurt a little, a very dry mouth and her tingling in her legs from the knee to the toe. The next day morning sore arm was better, but still experiencing the other side effects. Patient was concerned and would like to know if they were normal. The patient reported that she just got the first dose 03Feb2021 and scheduled for second dose on 24Feb2021. Her weight was a little low at the time of report as she was getting dental work done. Patient went to the site and it did not give anything in terms of if anything happened or what to expect. Patient had chills, and the glands around her neck were swollen. The injection site was sore, but she expected that. Her legs below knees and feet are crampy. Because of her age and lives alone, patient just wanted to know if this was normal. Her mouth was very dry and had been drinking water with lime she squeezed in it. This started after she got vaccinated around 11:00-11:30. Patient just wanted to know what was normal and what was not. She took temperature and does not have a temp 98.1. She just was feeling like she did not feel well. Patient wanted to know if this would pass. The place she got the vaccine, they did not give her any information except the date to return. Patient reported the day before reporting was worse. Her glands were still swollen, but not as bad. Her feet were still crampy and the toes, body just felt achy. Patient would like to know if these symptoms were normal and what the time frame was that she should expect them to continue. Investigation assessments included none. The outcome of the events chills, the glands in her neck, under her chin were swollen and hurt a little, her mouth has been very dry and drinking more water, her body just feels achy, injection site was sore and sore arm was recovering; event of below knee and feet and toes are crampy was not recovered; other events was unknown. Follow-up attempts are completed. No further information is expected.

itching; Allergic Contact Dermatitis; rash; welted; red; bruised and sensitive to touch; bruised and sensitive to touch; sore left shoulder at the injection site next day for one day only; This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL1283) via an unspecified route of administration on 19Jan2021 at 14:30 in left arm (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Not pregnant at the time of vaccination. The patient did not have any allergies to medications, food or other products. Medical history included atrial fibrillation (AFib) and hypothyroidism. Concomitant medication included multaq, bisoprolol and levothyroxine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, Since the vaccination. On 20Jan2021, patient experienced sore left shoulder at the injection site next day for one day only. On 24Jan2021 at 11:00 (5 days after vaccine), patient noticed blood on my shirt where she had been itching, left upper arm between injection site and elbow, appearance of skin was rash, welted, red, bruised and sensitive to touch in an area about 3x3 inches. OTC anti itch cream not effective. Itching became so severe, I went to dermatologist 3 days after itching started. diagnosed as allergic contact dermatitis due to covid 19 vaccine. Treatment received was anti itch cream and told to use cold pack when it was itchy and take OTC antihistamine. Followed doctor's orders and itching finally stopped after 12 days from onset. The adverse event result in visit to doctor or other healthcare professional office/clinic. Seriousness reported as non-serious. The outcome of events was recovered in Feb2021. Follow-up attempts completed. No further information expected.

Day 5 after shot, little itchy rash around injection site; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 04Feb2021 at 03:00 (at the age of 76-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included alendronate sodium (ALENDRONATE). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3249, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 14Jan2021 03:00 (at the age of 76-years-old) as dose 1, single for covid-19 immunisation in other facility. On 09Feb2021 at 08:00, day 5 after shot the patient experienced little itchy rash around injection site. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the event with self-hemp oil topical, and allergy pill. The outcome of the event was recovering. Follow-up attempts are completed. No further information is expected.

Cellulitis / Cellulitis in her leg; the right eye was sensitive to light; her eyes kept fluttering; It is still draining and is still a little red; It is still draining and is still a little red; right side of the face was swollen; both of her eyes were swollen; This is a spontaneous report from a contactable consumer or other non HCP (patient, self-reporting). A 77-year-old patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266 and expiration date was not reported), via an unspecified route of administration in arm left on 09Mar2021 at 16:30 (at the age of 76 years) as a dose 2, single for COVID-19 immunisation. infliximab (REMICADE), via an unspecified route of administration from 27Apr2021 (Batch/Lot number was not reported) and ongoing, at unspecified dose for crohn's disease. Patient's medical history included ongoing crohn's disease, She's had it for about 3 years, immune system disorder from an unknown date and unknown if ongoing, She has low immunity, skin cancer from an unknown date and unknown if ongoing, She had skin cancer. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9265 and expiration date was not reported), via an unspecified route of administration in arm left on 17Feb2021 as a dose 1, single for COVID-19 immunisation and remicade for crohn's disease. Additional vaccines administered on same date of the Pfizer suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine were and AEs following prior vaccinations were none. It was reported that, Patient who had both doses of the Pfizer COVID Vaccine. She had a birthday yesterday (date unspecified), so she was 77 years old when she experienced the events. She had her 2nd dose on 9Mar2021 and had a Remicade infusion on 27Apr2021. After her infusion, both of her eyes were swollen, the right eye was sensitive to light, her eyes kept fluttering while looking up or bending over, and the right side of the face was swollen. This was constantly happening but is now getting better but not completely over. She mentioned that she talked to several doctors and they think that Remicade, since it lowers the immune system and decreases white blood cell count and the vaccine increases the white blood count, it has interfered with the signals with her eyes. She was also hospitalized from 29May2021 to 2Jun2021 for cellulitis and was given some antibiotics and steroids which she thinks helped with her symptoms. She was asking if this has been reported and if this will happen again on 24Jun2021 for her next Remicade infusion. she was taking Remicade before giving her the vaccine. she had concern, would the vaccine affect the Remicade and cause these reactions. Upon follow up, It was reported that, patient had her second dose of the Covid Vaccine on 09Mar2021, and on 27Apr2021 she had a Remicade infusion. Both of her eyes were swollen, and the right side of her face was a little swollen. She wants to know if it could be an effect of the vaccine and if she will experience this again after her next infusion this June. she comes on the line. Her right eye was the worst. When she looked up it started to go closed. If she goes into a bright light it would go closed and bending over it would go closed. It would keep fluttering, and she would have to go sit down and close her eyes until it settled down. It interfered with her activities, and she didn't feel comfortable driving because she didn't know when it would hit her. Every time she talked to a doctor, they acted like she is crazy. It only seemed after the Remicade that this started happening, and now she was due for another Remicade infusion on 24Jun2021. She had some other health issues earlier this month and was put on antibiotics. The antibiotics seemed to help the eye it is not completely gone but better. She was wondering now if she should get the Remicade on 24Jun2021. She had skin cancer, and when they removed it, she got cellulitis in her leg. She was in the hospital for 3 days. She asked the doctor there and they brushed her off. The last day before she came home the nurse came in and wanted to know if she had her shot. She asked the nurse the same question about the vaccine and Remicade, and the nurse said now they ask people before they get the shot if they are on Remicade. The nurse didn't have anyone that said yes. It was seeming like there is some kind of problem with Remicade and the vaccine. That is why she was a little bit concerned about having it again. Event details Both eyes swollen: They were still swollen. It was reported that, Sometimes her right eye will still go closed. It has gotten better. Right side of face a little swollen: It lasted for at least a month. Cellulitis in her leg: That would have started on 21May2021. She went to the hospital on 29May2021 and came home on 02Jun2021. She doesn't know if it went away. She finished her medication on Wednesday, she took the last of the antibiotics they gave her to take at home. It is still draining and is still a little red. She doesn't think it is quite as red, but it is still draining. It is about the same. Along the way she went to Urgent Care. They put her on steroids that didn't help. A couple weeks after she got an infection and they had her on 3 or 4 different antibiotics. She didn't know if one helped, or it was just the Remicade wearing off. She was on 3 different antibiotics. One was Doxycycline and that didn't help. The other one they gave her to take home was Amox Clav 875, and it was 125mg. She took it 2 times a day for 6 days. Both of the antibiotics she took are in amber colored pharmacy vials. She doesn't remember the name of the steroid that she took. She had her first dose of the Covid vaccine on 17Feb2021 and second dose of the Covid vaccine on 09Mar2021. She has been on Remicade for many years, at least 3 or 4 years. Before that she was taking a pill. The Remicade is an infusion. They mix it up when she comes in. She did not know a dosage. She had gone to the eye doctor, and she did a bunch of bloodwork. The patient underwent lab tests and procedures which included blood test and computerised tomogram with unknown details. She doesn't know what bloodwork she did. She also had a CAT scan of her eyes in the hospital. The patient was hospitalized for cellulitis / cellulitis in her leg (cellulitis) from 29May2021 to 02Jun2021. She was in hospital for 3 days. Events did not require a visit to Emergency Room, but Physician Office visit is required. For her eyes she went to Urgent Care, and they said to make an appointment with an eye doctor. Family Medical History Relevant to the events were none. It was the Product Complaint, Product strength and count size dispensed: Amox Clav 185: 125mg strength. Outcome of the cellulitis / cellulitis in her leg was not recovered, both of her eyes were, the right eye was sensitive to light, her eyes kept fluttering, right side of the face was swollen were recovering. Outcome of it is still draining and is still a little and it is still draining and is still a little red were unknown. Information on the lot/ batch number has been requested.

Herpes Zoster - anti-viral and predizone. Shingles on my face (later called Ramsay-Hunt Syndrome), Nine weeks on I am still having pain although the initial rash is gone. Taking gabapentin 4 times a day.

Severe hives; This is a spontaneous report received from a contactable consumer, the patient. A 76-years old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the right arm on 26Jan2021 at 08:00 (at the age of 76-years old) as a single dose for COVID-19 immunisation. Patient medical history was not reported. The patient had no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Jan2021 at 13:00, the patient experienced severe hives since day of vaccine. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe hives was unknown at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

tremor; insomnia; intense itching; loose stools; This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was reported as unknown) via an unspecified route of administration on 26Feb2021 at 10:30am (at the age of 76-years-old) in left arm as dose number unknown, single for covid-19 immunization at Hospital. Medical history included breast cancer and known allergies as IgG reactions to many substances both from an unknown date and unknown if ongoing. No other vaccine taken on same date. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks. Concomitant medications received within two weeks included pregabalin (LYRICA); ascorbic acid (VITAMINS C); colecalciferol (VITAMIN D [COLECALCIFEROL]); melatonin (MELATONIN) and fexofenadine hydrochloride (ALLEGRA) all taken for an unspecified indication, start and stop date were not reported. The patient experienced delayed reaction two days after vaccination which included intense itching, insomnia, loose stools, and tremor on 01Mar2021. The patient received treatment for the adverse events occurred. The outcome of the events was Recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

RIGHT LEG SWELLING, PURPLE IN COLOR, ER VISIT REQUIRING DUPLEX SCAN WITH RESULT OF EXTENSIVE BLOOD CLOT DOWN ENTIRE LEG, 80 % BLOCKAGE. THREE DAY HOSPITAL STAY, INTERVENES TREATMENT OF HEPRIN

This is a spontaneous report received from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 16Mar2021 at 11:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included high blood pressure. Concomitant medications were not reported. The patient was allergic to latex, sulfonamide, cipro and eggs. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021,5 days after the vaccination, the patient had shingles . The patient applied cortizone as treatment for the adverse event. The event resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event shingles was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Since February 19th I have been in constant pain. Difficulty in walking, exercising, and every day activities. 1. Covid Toes: One inflamed, swollen and discolored toe on each foot. Constant pain. Painful to touch. Spurts of searing, burning pain on back side of toe. 2. Exacerbated arthritic pain in both hands. Joints in fingers and thumb are swollen and extremely painful. Voteran for treatment. Referral to Rheumatologist

headache; dizziness; fever; chills; Strong stomach pains; nausea; vomiting; distorted taste; new blisters on toes; finger pain; armpit pain; fatigue; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 10Mar2021 at 16:00 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to sulfa drugs, lidocaine, penicillin and mouthwash. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included aspirin (MANUFACTURER UNKNOWN) 325mg one pill per day. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration in the left arm on 14Feb2021 at 09:45 (at the age of 75-year-old) as single dose for COVID-19 immunisation. 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 11Mar2021 at 08:00 the patient experienced headache, dizziness, fever, chills, strong stomach pain, nausea, vomiting, distorted taste, new blisters on toes, finger pain, armpit pain, fatigue and brain fog. The patient did not receive any treatment for the events. The clinical outcome of the events headache, dizziness, fever, chills, strong stomach pain, nausea, vomiting, distorted taste, new blisters on toes, finger pain, armpit pain, fatigue and brain fog was recovered with sequela on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

-March 4, 2020 - Morning after vaccine - Ankles swollen. I never had swollen ankles in the past. Bumps under skin on right forearm - felt like sand pebbles under skin. That has continued and is present now also. - March 6, 2020 - Breathing became tight - remained that way for a good two months. Shortness of breath - Month of March - Rash was breaking out on lower right leg and lower back. itchiness ( But, I was unaware that it was Covid Vaccine related) Gradually became larger rash on right shin area. Right ankle and leg started to swell. - Last week of March, First Week of April - Right leg became more swollen and inflamed. Then became frighteningly swollen. Rash on arms increased. April 15, 2021 - Dermatologist appointment - He told me that the protective barrier on my skin had broken down. Prescribed Steroid cream, and CereVe moisturing cream morning and night. Cetaphil Gentle Skin cleanser used very sparingly on only parts of body absolutely necessary to wash, but not on rash area. No hot showers ever again. He said he would not need an antihistamine. Refused to address swollen leg and ankle. ( Your site tells me it is closing, so I do not have time to continue.)

she has developed chills; her fingers were turning blue.; her fingers were turning blue.; This is a spontaneous report from a contactable consumer and from a Pfizer sponsored program COVAX US support. This 76-year-old (age at vaccination) female consumer (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EN6207, expiration date; 31Jul2021, Pfizer COVID 19 vaccine manufacturer; Unspecified, NDC number; unknown) via an unspecified route of administration on 17Mar2021 at 10:30 at left arm as dose 2, single for covid-19 immunisation. Vaccination facility was Health and Wellness Center. Patient's medical history included blood pressure high, high cholesterol, knee replacement from Jul2020 to unspecified, heart problems, breast cancer (dates unspecified). Patient mentions predating treatment with the Pfizer COVID 19 vaccine, she had knee replacement surgery in Jul2020 and Nov2020 and had a COVID 19 test done before each time. Both the COVID 19 test from Jul2020 and Nov2020 were negative. Family History included mother heart problems; sister breast cancer; daughter breast cancer; father cancer. Relevant tests included two COVID-19 tests both negative on Jul2020 and Nov2020. Historical vaccine included first dose of BNT162B2, lot number: EN6199, on 24Feb2021 at 10:30 am in left arm for covid-19 immunisation. Concomitant medications were not reported. Prior vaccinations (within 4 weeks) were reported as none. Consumer had the first dose of the Pfizer COVID-19 vaccine on 24Feb2021 and had no reaction after. Consumer got the second dose on 17Mar2021. On 24Mar2021, she has developed chills and her fingers were turning blue on 24Mar2021 to ongoing. Reporter seriousness for the events was unspecified. The AEs did not require a visit to emergency room or physician's office. Consumer wanted to know if that is an adverse events associated with the vaccine and if those are adverse events that would go away. She also would want to know if she should go to the ER for it. Consumer states she has received both of the vaccines. Last week on 17Mar2021 she got the second dose. Then on 24Mar2021 she noticed chills; and her hands and fingers turned blue. They are still that way today. She didn't know if she should call Pfizer or call the wellness center. She is asking if this will go away or should she go to the ER? Clarifies she received the first dose of the Pfizer COVID 19 vaccine on 24Feb2021 at 1030 am in the left arm and had no reaction. Then she had the second dose on 17Mar2021 at 1030 am in the left arm. Patient does not see NDC on her vaccination card. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

Patient c/o itching and hives that evening and went to bed. Patient states she took a Zyrtec home dose. Patient denies any trouble breathing. Associate states she came to hospital to report the event just in case. Patient states the itching and hives have resolved at this time.

Softball size, raised, red area with warmth around the injection site. (Right Deltoid) Started on Keflex 500mg TID X 7 days and ice packs to area until redness resolved Reaction on 12/27/20 Resolved on 1/3/2020

Injection site on left arm of resident turned red, warm, and firm. Reaction began two days after injection. Chief nurse directed resident to contact their Primary Care Provider.

rash occurred on a recent surgical wound/rash developed on the back crease of her legs and neck/severe rash that got worse/general practitioner got steroids to help with itching; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3246, via an unspecified route of administration to left arm from 02Jan2021 to 02Jan2021 as SINGLE DOSE for COVID-19 immunization. Medical history included spinal surgery and surgical wound, a 7 inch scar along her back/she had spinal surgery and has a 7 inch scar, she had no problems. There were no concomitant medications. The patient reported a rash that developed after receiving vaccine on 02Jan2021. On 03Jan2021, her rash occurred on a recent surgical wound, a 7 inch scar along her back. The rash also developed on the back crease of her legs and neck. She has been managing her symptoms with Benadryl. The patient was asking is others has reported this side effect. The patient is also asking if she can get the second dose of the vaccine. Her surgeon suggested perhaps not receiving second vaccine. It was further reported as, "got Pfizer COVID-19 Vaccine on Saturday. Next day had a severe rash that got worse. Saw her general practitioner this morning and got steroids to help with itching. No further details provided, wants to know if she should forgo the second shot. The patient stated she was fortunate to get the Pfizer vaccine, later clarified as Pfizer COVID vaccine, Saturday in the early am, then on Sunday, developed a rash over part of her body, she can control with Benadryl, the itching, but the weird part, is a month ago, she had spinal surgery and has a 7 inch scar, she had no problems, like no reaction to glue, but the rash is concentrated down both sides of the scar. She had an appointment with her surgeon today, and showed it to him, since she thought it was unusual, and he said she may not want to take the second dose, it was not a terrible rash all over her body, mainly concentrated to the area of her back, and it is like a little bit on the back of her neck, not even anything she would notice, but it is there. The patient stated she can't get through to the Health Department, and she has a card to say to have the second dose on 23Jan2020, but she can't get through. States thanks so much, this is a miracle event and in a year's time, even if she did get a rash. The rash is a little more pronounced, but she has been rubbing it trying to not scratch, but it doesn't seem to be spreading any at all. States she is healthy. Seeking more information about getting the second dose after experiencing a rash. The outcome of the event was unknown.

arm was slightly swollen; rash around the injection site; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284, expiry date: unknown), via an unspecified route of administration on 02Jan2021 08:00 at a single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient noticed her arm was sore a few hours after vaccination on 02Jan2021. Yesterday on 03Jan2021, her arm was sore. On 04Jan2021, when getting dressed she noticed her arm was slightly swollen and there's a rash around the injection site. Outcome of the events was unknown.

within 45 minutes my face turned bright red and felt very warm lasted for a day and a half otherwise felt fine

Patient received vaccine on 1/21/21 and then was waiting for 15 minutes per clinic protocol post vaccination to monitor for any adverse reactions. Patient reported that she began having some numbness and tingling down arm where vaccination was administered and into her hand and fingers of that arm. Patient denied any other symptoms that were different than her normal baseline. Patient declined further evaluation or medical treatment at DCMH and reported that she just wanted to return home to monitor symptoms. Encouraged patient to contact DCMH or PCP for any worsening or continuation of current symptoms, any additional reactions or concerns, pt. verb. understanding at that time. This nurse contacted patient later in the day to follow-up and at approx. 1520 (01/21/21) patient reported at that time that symptoms had resolved.

Noticed the next day after the vaccination my arm was sore, then itching with hives. Took Benadryl and put some cortisone on it to stop the itching.

Saturday evening 1/23/21 after vaccine, just all of a sudden from one moment to the next, left hand was very tingly and tight feeling and could not move very easily. A few minutes later her lip from the center left was also tingling, and then spread to entire left side of her body from head to feet, like her left side feel asleep that tingly feeling and numbness. Began to be worried, called 9-1-1 and the EMT reassured her that she was not having a stroke, and told her that they had heard of it before. Still today, Monday 1/25/21, particularly in her left hand which she is not able to use very much. Did take Ibuprofen but nothing else.

After a few days, muscle/joint pain ....headaches.....Tiredness......injection sit pain.... all were bearable and strong to disappear when i waek after the short I got Horrible chills, completely out of control, had to wear my night guard to stop teeth from getting chipped, lasted 3 or four hours. Could not warm up, had two down comforters on. The chills eventually stopped but the headaches Intensified, also I could. Or move my near and shoulders. Went to the ER, they did not believe it had anything to do with the shot, I was there for 12 hours, had head exrays, spinal taps to test for meningitis, they searched for anything else I might have...nothing else.. they would not say if I should have the second shot, called pfiser this morning, they could not tell me if I should have the second shot, that I should aske my doctor.......If Pfiser doctor does not know if it is safe how could my country doctor.

Approximately 4 hours later, experienced itching on the top part of the chest. Upon checking, the area had developed a rash with high red bumps, redness around the area and smaller bumps as well.

Slight swell in face, lips, cheeks; feeling of tightness; redness in face;, some nasal drainage. Similar to reaction to hot peppers. Took 1 Benadryl tablet. Symptoms subsided over 24-hour period.

On day 7 after vaccine a red rash ( dotted spots like pimples) developed at vaccine site covering Approx 4" in diameter. The next day the whole area turned into one large red spot approx. 4" in diameter. There is an itch and slight swelling with slight pain. Also warm to the touch.

ABOUT AN THIRTY MINUTES OR SO AFTER THE SHOT THE PALM OF MY HANDS AND BOTTOMS OF MY FEET STARTED HEATING UP AND TURNING RED. I TOOK A BENADRYL AND IT HELPED A LITTLE. SUNDAY THE SHOT SITE STARTED TURNING RED AND WAS SWOLLEN A LITTLE LARGER THAN A QUARTER.

couldn't sleep; sudden hearing loss; complete hearing loss a few days later/hearing loss in right ear; constant humming in her right ear/getting hissing in my ear; arm felt tender; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was either: EL1283, CL1283, or LL1283) on 11Jan2021 at 11:00 at single dose in left arm for COVID-19 immunization. Medical history was none. There were no concomitant medications. Patient previously took pneumonia shot on an unknown date and flu shot in Oct2020 for immunization. Patient got the first dose of the vaccine on 11Jan2021 at 11:00 in the morning. On 11Jan2021 her arm felt tender where the needle went in.On 12Jan2021 late afternoon, she started getting hissing in her ear that was still there and had not gone away at all and she also had a constant humming in her right ear. By 13Jan2021, she still had the humming. She saw an ENT on 13Jan2021 and doctor didn't know if it was correlated to the vaccine or not; doctor took some wax out of her ear and she seemed to get relief from the hissing for about 15 minutes but about 15-20 minutes later the hissing/ humming continued. On 14Jan2021, woke up with complete deafness in right ear. Immediately called ENT doctor and did a hearing test. Patient could not hear and they confirmed she had sudden hearing loss in her right ear on 14Jan2021, she had nothing in her right ear (as reported). They put her on 40 mg a day of Prednisone (20mg tablets) and so far, prednisone hadn't done anything: originally taking prednisone 40mg for four days and was taking two a day; on 16Jan2021 when she was getting no relief and couldn't sleep due to the humming in her ear, she called doctor and was advised to take the 40mg together in the morning, she will take 40mg a day. On 19Jan2021 she took 20mg for four days and then decreased by half again. She was also advised by doctor to take 25mg Benadryl (UPC: 30048284 Lot: SPS023 Exp: Jun2022) at night. They are scheduling her for an MRI in Jan2021.Patient was also scheduled for the second dose on 01Feb2021 and will be on the prednisone until 26Jan2021; she would like to know whether the prednisone will diminish the effectiveness of the vaccine. She also asked if there was a certain amount of time she should wait to restart in case the doctor decided she should not get the second dose; she also wanted to know if she should wait on the second vaccine and maybe start over in two months.She was concerned and wanted to know if she should proceed with the second shot. The patient underwent blood work on an unspecified date to see if she can receive contrast for an MRI. She never had problem with MRI contrast before. Final outcome of the events was reported as unknown.

experienced allergic reactions; her eyes got red; Her eye lids were red; Her eye lids were red, swollen, and puffy.; Her eye lids were red, swollen, and puffy.; cheeks were bright red; This is a spontaneous report from a contactable nurse (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration on the left arm on 14Jan2021 14:00 at a single dose for Covid-19 immunization. Medical history included that the patient was diabetic and hypertensive; both were ongoing. Concomitant medications included atenolol taken from 14Jan2021 for blood pressure high; pioglitazone hydrochloride (ACTOS) and ongoing metformin both were taken from an unspecified date for diabetes; ongoing montelukast sodium (SINGULAIR) for history of food and drug allergies and ongoing chlorothiazide for diuretic. It was reported that she had the first dose of the covid vaccine on 14Jan2021 and experienced allergic reactions after she left the facility; they were not life threatening but were not pleasant. She realized how bad it was after she got in the car, removed her mask, and looked at her face. She was concerned about getting the second dose. She even took Benadryl 1 hour before getting the shot and still had a reaction. She clarified her allergic reaction to be as her eyes got red. Her eye lids were red, swollen, and puffy. It looked bad. When she got in the car took her mask of her cheeks were bright red. She sat in the ER parking lot for an hour waiting for it to resolve. It resolved after like an hour and half. After it resolved and went away she went back home. She stated that this allergic reaction is anxiety producing. She gets anxious because she knew what could happen. The outcome of the events was recovered on 14Jan2021.

Starting about 3 hours after the injection, right arm began feeling sore at the injection site. Discomfort turned into pain in the late afternoon and evening, to a maximum pain level of about 4 by bedtime. Pain level was down to about 2 or 3 by the next morning, and that continued throughout the next day.

Patient waited 30 min given prior history of reactions to medications (rash, no anaphylaxis) with other medications. Left after 30 min with no complaint. Allergies Allergen Reactions ? Niacin Other (See Comments) Other Reaction: Other reaction ? Penicillins Rash ? Amlodipine Swelling ? Flagyl [Metronidazole Hcl] Other (See Comments) Other Reaction: Other reaction ? Lipitor [Atorvastatin] Rash ? Zocor [Simvastatin] Other (See Comments) and Unknown Other Reaction: Other reaction ? Colesevelam Other (See Comments) severe ? Metronidazole Rash ? Colesevelam Hcl Other (See Comments) severe She returned after approximately another 20 minutes to report rash and mild pruritis on upper chest and face. No complaints of shortness of breath, chest tightness, lightheadedness or dizziness. No facial swelling, pallor or cyanosis. No increased effort of breathing or wheezing appreciated. Skin only reaction, no respiratory, cardiovascular or GI reaction. On exam- 140/70 HR regular rate and rhythm. Lungs clear No cyanosis or pallor noted Patient able to converse normally, A+O , in no acute distress Mild erythema around mouth, no tongue swelling appreciated. Mild erythema between brows. Mild blotchy erythema on upper chest. Given oral diphenhydramine 25 mg at 4:30. No progression of symptoms and patient observed another 30 minutes without change. Given a oral diphenhydramine 25 mg to take with her in the event symptoms progress or to take as a second dose in 4 hrs. If any worsening symptoms she is to seek emergency medical attention. I will follow up with her this evening and tomorrow. I will provider her formal recommendations regarding her second vaccination. I spoke with her at 6:50- she is stable, still mild rash on upper chest, but no new symptoms. She will repeat with diphenhydramine 25 mg at 8 pm and I will check on her tomorrow. She is motivated to receive her second dose but asks if receiving a different medication is an option We will discuss this further tomorrow. I spoke with patient again on 1/21/21 at 8:30 am. She continues with mild rash on upper chest, will continue benedryl for mild itching, but no further progression of rash, no residual facial erythema and no shortness of breath or other new symptoms. I have asked her to consider premedicating with 50 mg diphenhydramine 1 hr prior to dose 2 of vaccine. I have also asked her to register with v-safe and have sent her the information in case she did not keep the paperwork. Pt then saw PCP several days later who suggested she not receive second vaccination

Burning pain going down into the forearm on the same side vaccine given; This is a spontaneous report from a contactable pharmacist. A 77-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730) via an unspecified route of administration on 13Jan2021 12:30 single dose for covid-19 immunisation. Vaccine location was left arm. Patient did not receive any other vaccines that day and none 4 weeks prior. Medical history was none. There were no concomitant medications. The patient experienced burning pain going down into the forearm on the same side vaccine given on 17Jan2021. She has never experienced anything like this before having that vaccine. The event was reported as medically significant. The outcome was not recovered.; Sender's Comments: Based on the reasonable temporal association and considering he known safety profile of COVID-19 vaccine, BNT162B2, the Company considers there is a reasonable possibility that the reported "burning pain going down into the forearm on the same side vaccine given" is related to BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Itching/She was itching on her knee, leg, arm, neck, and ears.; She had hives on the knee; The two that had her most worried was the memory loss and chest pain; Chest pain; It was like she went blank. She was looking around and she could not remember names she was trying to figure out name street; Spasms/spasms were like in her back where her shoulders were and it was bulging; It hurt from her neck and up into her head.; It hurt from her neck and up into her head.; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3246, expiration date unspecified), via an unspecified route of administration on 10Jan2021 (around noon) at single dose (left arm) for COVID-19 immunization. Medical history included ongoing diabetes, ongoing blood pressure high/blood pressure, ongoing heart problems; heart disease, kidney disease, history of itching, fluid (imbalance), stroke so taking for clotting, history of neck issues and she was allergic to a lot of medications. Ongoing concomitant medications included ubidecarenone (COQ-10), zinc, torsemide for fluid, clopidogrel for had a stroke so taking for clotting, insulin glargine (LANTUS) for diabetes and isosorbide mononitrate, carvedilol, irbesartan and amlodipine, all for blood pressure. Patient reported that she got the injection on Sunday and then later she started to get spasms on 12Jan2021. These spasms were like in her back where her shoulders were and it was bulging and it hurt from her neck and up into her head. She mentioned she was 77 years old and sometimes she has to think about a word before she gets it out, but yesterday (14Jan2021) it was different. It was like she went blank. She was looking around and she could not remember names she was trying to figure out name street on and this lasted 15 minutes and then it went away. She confirmed she does not have it right now. It did not last a long time, but it scared her so bad. Then yesterday evening (14Jan2021), she started to have funny chest pain. She told her husband if it did not go away she would go to the ER. However, after an 1 hour it went away. It was like a sticking pain. The chest pain lasted for an hour and started around 18:00. On an unspecified date, she started itching at night. She has a history of itching, but this was out the box. She had hives on the knee. It was crazy. She itched all over. She had to get out of bed and sit in a chair until 1:30AM. She was still itching, but it was not as bad. Patient reported that due to the kidney disease she has itching, but the itching she was having after this COVID Vaccine was different and more. It was out of the box. She confirmed this was the first injection and now she was scared to get the second injection. Patient reported that the itching started when she went to bed. She went to bed around 21:00 and around 21:30, she got out of bed because she was itching so bad. She stated there was not anything different on the bed. It was the same thing that was up there the night before. She did not change the sheets or anything. She had to get up and sit in a chair and she could not believe how bad her knee was itching. She was itching on her knee, leg, arm, neck, and ears. She stated she takes a lot of medications. She was very funny with medications and they have to work with her to get the right one for her. Due to having these other conditions was why she wanted to get the COVID Vaccine. She reported she will have her blood drawn next week. The two that had her most worried was the memory loss and chest pain. However, these passed and she did not go the ER or physician office. She was afraid if she gets the second injection this will happen again and she may not come out as well form it. Prior vaccinations within 4 weeks was none. Outcome of events spasms/spasms were like in her back where her shoulders were and it was bulging and itching/itching on her knee, leg, arm, neck, and ears was recovering; chest pain was recovered on 14Jan2021 at 19:00; and outcome of the rest of events was unknown.

Diarrhea; Upset stomach/stomach was jumping around; she woke up during the night after her stomach was jumping around yesterday; her arm was not real sore, which she was surprised. She says that if she touches the injection site she can feel it; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), via an unspecified route of administration in the left arm, on 16Jan2021 11:30, at single dose, for COVID-19 immunization. Medical history included ablation and watchmen procedure (successful) both in 2020, atrial fibrillation (A-fib) and sensitive stomach. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN 81 mg, lot number: NAA80DX, expiry date: Aug2021). The patient reported that she had her first dose of the vaccine this past Saturday (16Jan2021), and she did not have adverse events, but she was having some upset stomach on 17Jan2021 and diarrhea on 18Jan2021 and would like to know if this could be a side effect. She stated she woke up during the night of 17Jan2021 after her stomach was jumping around. She stated she has a sensitive stomach, anyway, normally; and her arm was not real sore, which she was surprised. She said that if she touches the injection site, she can feel it (pending clarification), but it is not throbbing, aching, or swollen. She stated that she was not sure if it could be the spaghetti they had for dinner, but this morning (18Jan221) she had some diarrhea. When asked about treatment, she said she didn't take anything for this because she doesn't like to take medicine, and if it is from the vaccine it should go away in a day or so but her diarrhea stayed about the same and has not gotten any better or worse. She also noticed the paperwork that said don't take Ibuprofen, Aspirin, or blood thinners, and mentioned she takes baby aspirin every day, she wanted to know if that was okay. The outcome of the event diarrhea was not recovered; and the remaining events was unknown.

bad allergic reaction; itching and welts, like hives; itching and welts, like hives; didn't get any sleep last night; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302 and expiration date not provided), via an unspecified route of administration in the left arm on 18Jan2021 18:00 at a single dose for COVID-19 immunization. The patient has no medical history. Concomitant medication included other medications that she has never had a reaction to. The patient stated that she got her first dose of COVID vaccine on 18Jan2021 evening. On 19Jan2021, she had a bad allergic reaction, itching and welts, like hives or whatever that started on her arms that progressed to the rest of her body especially the buttocks, everywhere. She did not get any sleep on 19Jan2021 and was itching. She called the doctor's office to see if they could help her and they said they couldn't and told her she needed to contact the health department "or something." They aren't familiar with the vaccine and does not want to do anything that would put them in a legal situation. She stated she has an appointment on 08Feb for her next dose and she doesn't know if she can go through this again. She asked what can she do about this reaction. She started to get itching and "stuff" that was not bad until last night (unspecified date). She stated that it was like she had hives all over and itching out of control. She did not get any sleep and is still itching out of control. She wanted to know if she goes back to hospital if they will be able to do anything for her. It was her first shot and is scheduled for her second one on 08Feb2021. She was wondering will she have to go through all of this again. She had noticed hives on her arms on 19Jan2021 morning but mostly now are on her buttocks and thighs. She stated that she had thought it was an allergic reaction to a fabric softener that she changed to. No treatment was given in response to the events. She has stated that she takes other medications that she has never had a reaction to. She does not think that they were related to this. The outcome of the events was not recovered.

Friday evening (Feb.5th) after taking off my socks saw I had a dark red rash around my ankles. It did not itch much. The next day on Saturday I had more red spots but not quite the same as around my ankles. More up my legs to my knees. This morning (Sunday Feb 7th) I now have more spots on my arms. These spots are not like the dark reds ones around my ankles. I also have a spot on my face. I went to the Urgent Care in my area and the opinion of the doctor on call these spots may be related to my vaccine even though it has been 2 and 1/2 weeks since I had the covid vaccine. Up until this eposide I have not had any reaction to the vaccine. They suggested I contact you with this information. I was given a Medrol Dose Pak for the rash. The doctor was not sure the vaccine was the cause of my rash. I would appreciate if someone would contact me and let me know if I should not take my next vaccine which is scheduled for Feb.10 at 9:45 AM.

Pt developed Shingles after vaccination. Notes from call to PCP day after vaccination: "Since yesterday morning after vaccine after she received her covid vaccine, she noted that her right ear hurts. She says that the pain does not feel like it is in the ear but right around the ear, and the bones around the ear. She says it hurts to chew, and the area to the back of her ear has ringing sound. She does not note that the ear is red . When she rubs under the ear she says the area is painful is painful. She does not note a lump or bump under her ear.. She states that the jaw/bone area hurts with the vibration of the conversation." Sore throat and headache, only on right side. Pain progressed to the point of hospitalization, with vesicles erupting on right side of face/ear canal.

24 hrs after shot i ran low fever and head ache. i had fatigue, But then i started 2ays later feeling like i had inflammation in my butt, external in vaginal area and was hard to use the restroom and back of thighs area. felt like a had a rash but there was nothing there. like it was burning. it just felt inflamed. It felt good to apply cold to it. it lasted until the next day.

arm pain; itching; It's become difficult to move her arm and has worsened since the injection/ I had a hard time lift my arm in changing clothes; It's become difficult to move her arm and has worsened since the injection/ I had a hard time lift my arm in changing clothes; I feel in my arm, around that shot you know I had the injection, start itchy start feel itchy; my arm feel pink, it's swell up and it's scratch; my arm feel pink, it's swell up and it's scratch; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date not reported), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included bone disorder (reported as bad bone problem). Concomitant medication included denosumab (PROLIA) for bone disorder. The patient received her first injection on 09Jan2021 and had been experiencing arm pain which was mild to moderate but about a week later she developed itching in the same arm. It's become difficult to move her arm and had worsened since the injection. She wanted to know if this type of experience had been reported and if she should receive the second vaccination scheduled for the 30th. The patient stated that she had a hard time lift my arm in changing clothes and she can't her shoulder. After one week later about almost 1 week later she felt in her arm, around that shot she had the injection, started itchy started to feel itchy and she was afraid maybe infection, dead skin, maybe infection or something. She showed it to her friend, saying "Look my arm feel pink, it's swell up and it's scratch, it's itchy." Clinical outcome of event "difficulty to move her arm and had worsened since the injection" was not recovered while for the other events was unknown.

Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported itching at injection site and in throat. Initial vital signs within normal ranges except pulse 100-110 beats per minute and blood pressure 180/90 mmHg. Patient administered diphenhydramine 25 mg orally and transported to the emergency department. On arrival and during physical exam patient noted to have red "splochyness" on chest wall but no hives. Patient awake, alert, oriented: no shortness of breath, stridor, or oral or pharyngeal swelling. Patient observed, symptoms improved, vital signs stable, and discharged to home.

3 hours post-vac: hives on scalp and rt side of forehead. Itchy scalp. 4 hr post-vac: itchy on stomach.

Started 10 days after she received the vaccine, 2/7/21, found while washing her head, bumps on her head. This progressed to her neck and on Monday 2/8/21, noticed that it was behind her ear. Yesterday and today she has noticed that it has traveled more to her throat area. She has taken Tylenol and this seems to have helped. The symptoms seem to subside while on the Tylenol, but after 6 hours she then notices that the feeling is coming back.

trouble sleeping; right arm plus red; right arm feel ithcy inside; night chills; headache; arm hurting/right arm pain was more painful; This is a spontaneous report from a contactable other health professional (reported for herself). A 77-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (Batch/lot number: E69261), via an unspecified route of administration in right arm on 27Jan2021 11:15 at single dose for covid-19 immunisation in hospital. Medical history included, two stents, hernia, prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included omeprazole, rosuvastatin, ticagrelor (BRILINTA), metoprolol, sucralfate (SUCRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin sodium; clavulanate potassium (AUGMENTIN), carisoprodol, clopidogrel bisulfate (PLAVIX) all experienced allergies. First it was arm hurting first night on 27Jan2021, then next night on 28Jan2021 chills, headache occurred, last night on 29Jan2021 she had trouble sleeping. Her right arm pain was more painful, plus red, feel itchy inside, took diphenhydramine (BENADRYL) 1 tablet. The events were non-serious. The patient's COVID test post vaccination included nasal swab on 27Dec2020 with result negative. Outcome of the events was unknown.

Date and time of vaccination: (list both if they received both shots): 1/6/2021 (First dose) 1/27/2021 (second dose) redness, swelling at injection site, feels like fat hanging from the arm. still occuring

chills, shakiness followed by feeling very warm, sweating and sweaty, Extreme fatigue, body aches, joint pain. Injection site pain. Muscle pain. Nausea--did throw up twice. General feeling unwell. The fatigue has gone on for two weeks now. Starting to get better.

Right arm at injection site red, slight rash, very itchy and slightly swollen Occurred 9 days after shot given on 1/31/21

I developed a rash under my left arm on Feb.1,2021. By Feb. 3, it had spread to under my right arm, my trunk, back and inner thigh area. The rash exhibited a classic pine tree pattern with an initial herald patch under the left arm. The rash is consistent with a diagnosis of Pityriasis Rosea. Over the last 5 days, the rash has begun to fade on the trunk and back and the herald patch has disappeared during the laast 24 hours. A low level if itching has been treated with 25 mg. of Benadryl taken at bedtime.

dont want to eat anything; hot and cold chills; headaches; muscle pain; fever; joint pain; injection site swelling; redness; nauseated; swollen lymph nodes on throat; face swelling; fast heartbeat; body didn't feel well; chills; didn't feel like herself; light headed; felt weak; tired/slept all day; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 22Jan2021 15:30 at a single dose on right arm for COVID-19 immunization. Medical history included breast cancer 16 years ago, patient on defibrillator from Oct2016 (it was reported that this past October2020 would have been 4 years since she had the defibrillator put in), ongoing congestive heart failure, ongoing (COPD) chronic obstructive pulmonary disease, sinuses problems, back and hip problems, positive for COVID-19 from 11Jan2021, and hurting. The patient's concomitant medications were not reported. The patient previously received flu shot for immunization on unspecified date. On Saturday (23Jan2021), the patient reported that she "slept all day, felt weak, light-headed, and tired". The patient stated, "I have problems breathing anyways". The patient stated she "doesn't want to eat anything". On Sunday (24Jan2021), the patient "felt good", then Monday (25Jan2021), "didn't feel too bad". On unspecified date, patient experienced hot and cold chills, body didn't feel well, and breathing problems. She has breathing problems because she has COPD. Other things in the list of the adverse events (from the paperwork she was given) that the patient experienced include tiredness, headaches, muscle pain, chills, fever, joint pain, injection site swelling, redness, nauseated, feeling unwell, swollen lymph nodes on throat, face swelling, a fast heartbeat, dizziness, and weakness. Right now (26Jan2021), the patient did not even feel like going to her doctor's appointment (on Thursday). She just didn't feel like doing anything. She didn't feel like herself on 26Jan2021. She clarified on 11Jan2021 (prior to vaccination), she went to hospital because she was hurting. She clarified it was in and out of the Emergency Room. She was never admitted into the hospital. They ran some tests urine, blood, EKG tests. All the tests came back good. The patient underwent COVID test on 11Jan2021: positive; and same test on 22Jan2021: negative. Outcome of the events was unknown. Information about lot/batch number has been requested.

6 days after receiving the vaccine the patient developed a spotty rash in multiple places on my body. Patient is saying it is itching. I examined the patient today 2/12/2021 I prescribed Benadryl Cream and Benadryl tablets.

One hour after receiving the vaccination, I had an uncontrolable bout of diarrhea in a public place. Later in the day, I felt fatigued, and aching, and my left arm started to get very tight and sore. The next day I felt the same, and my lymph nodes under both my arms began to swell and hurt and my rectum began to have severe pain. Still had diarrhea. By day 5 my left arm ,at the site of the injection ,started to swell, get very hot ,and a large, bright red welt appeared which almost reached my elbow and went across the width of my upper arm.. I called my doctor and went to see her on the next day because it had gotten worse. She thought it was a local reaction and recommended ice, tylenol and benedryl. Again, as with the first shot, I am not sure if this is an allergic reaction or not., but thought I would report it.

jan 6 first dose--jan 27 second dose calling to report arm swelling after the second dose of vaccine vaccine--went down with ice--started this Sunday Feb. 7--subsided on Wednesday Feb. 10----claims to day she got a big red/rash mark underneath the naval--no other s/s she went to the hospital today

Patient tolerated her first dose of the COVID19 vaccine well, but her second dose on 02/12/2021 was not tolerated as well. Patient experienced 4 days of a low-grade fever, fatigue, facial flushing, injection site pain, and itching of the upper arm with little relief from OTC ibuprofen. Recommended OTC acetaminophen and a follow-up appointment with her PCP.

Received 2nd vaccine on 2/4/21 developed redness below injection site on 2/7/21. Redness continued and spread down arm. Contacted clinic with this information they took report. I was told to contact my personal physician. Called on 2/9/21 was given appointment to be seen 2/10/21 she diagnosed - cellulitis and i was given Rx for Cephalexin 500 MG.

Patient presents to ED with hives and lip swelling. Treated with IV diphenhydramine, methylprednisolone, famotidine, and oral cetirizine. Symptoms improved.

Pfizer-BioNTech COVID-19 Vaccine EUA Within approx. four hours of receiving the vaccine, I had several red welts develop on my abdomen. Over a period of several days, these welts spread to my back and were angry, red and painful. Since then, they have blistered. I went to a walk-in clinic because my primary care physician clinic was closed due to lack of power. At the walk-in clinic, I was diagnosed as having shingles. I had the shingles vaccine in 2014. I am now taking Acyclovir 800 mg five times per day. I am also taking L-Lysine with meals and Oxycodone-acetaminophen for pain.

Itchy burny skin rash started in right armpit and lower back, then migrated sequentually to left armpit, the sides of both breasts, the back of the right shoulder, the left thigh, and finally to the abdomen. The rash starts as fine red spots that later become inflamed and join to form large irregular patches that could be a 2 or 3 inches in diameter. Televisited primary care physician who prescribed Zyrtec twice a day and Caladryl topical lotion and referred me to a dermatologist who prescribed 0.05% Clobetasol Propionate Ointment and Benadryl as needed. The rash persisted and became worse after the 2nd shot 21 days later, but was fading slightly and was less itchy and burny just before the 2nd shot. Will report 2nd shot events separately later.

Itching/hives bilateral axilla. Sensation of lump in throat/itching tingling in throat. EMS on site. Patient's Epi-pen used left thigh. EMS started IV in left AC gave fluids and gave 25 mg Benadryl IV. Vitals monitored. Symptoms improved shortly after medication administration. Med unit transported patient to hospital for further evaluation.

pt stated that she developed hives on her torso and both legs down to the knees and slight headache after taking the covid. Pt states her symptoms are improving.

This is a spontaneous report from a contactable other healthcare professional (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN5318) via an unspecified route of administration on the left arm on 31Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included diabetes (reported as diabetis), high blood pressure, allergy to penicillin and sulfer; and COVID-19 (prior to vaccination). Concomitant medications included metformin, apixaban (ELIQUIS), valsartan, propafenone and amlodipine besilate (AMLODI). On 31Jan2021 10:30 AM, the patient experienced redness, warm and itchy around injection site. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Patient was not pregnant. 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered.

RN administered shot subcutaneously (versus intramuscularly as indicated). By evening, patient with swelling, redness, warm & hard to touch at injection site, with pain.

Very low energy upon waking on morning after the vaccine. Lasted all day. Felt feverish but no fever. Slept most of day until late afternoon when I finally took 2 aspirin. Injection site tenderness.

red rash appeared on chest. Within another 24 hours it moved over entire body...very red; red rash appeared on chest/ very red and extremely itchy; This is a spontaneous report from contactable consumer (patient). A 77-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration on left arm on 23Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included ongoing non- hodgkin lymphoma. Concomitant medication included ursodiol, furosemide, spironolacton, propranolol hydrochloride (PROPRANOL). Approximately 24hours after vaccination a slight fine, red rash appeared on chest. Within another 24 hours it moved over entire body. very red and extremely itchy on 24Jan2021. visited myoncologist and was prescribed Benadryl and cortisone cream for itch. The outcome of the events was not recovered.

Large local reaction to the injection site starting day of injection and worsening over 4 days time. Secondary cellulitis developed requiring antibiotic treatment.

Experienced bad taste in my mouth right away, lips felt weird, breathing very raspy, chills, itching on head, ears, arms, headache, swallowing issues, stuffy nose, sinus pressure, extreme fatigue, dry mouth (felt like cotton in my mouth), temperature dropped. Took about five days to feel okay. Took Benadryl (took twice with six hours between doses, took antihistmine, Levocetiriine, used pro air quite often, 20 mg of Prednisone at 2:30 am on the 22 and finally felt relief. Dr.. was informed after I got better.

Progress Notes (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All 2/25/2021 Date: 2/25/2021 Subjective a 77 y.o. female who was seen at Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience L hand numbness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, rapid progression of symptoms and respiratory distress. PMH includes DM, HTN, asthma. Takes metformin and losartan around noon every day. She has not taken her bp medication yet today as she takes it with lunch. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, muscle aches, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/25/21 1145 02/25/21 1201 BP: (!) 160/97 124/83 Pulse: 72 SpO2: 99% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No cranial nerve deficit or facial asymmetry. Sensory: Sensation is intact. No sensory deficit. Coordination: Coordination is intact. Gait: Gait abnormal (walks with walker, steady gait). Comments: +5/5 strength against resistance to both upper and lower extremities. Assessment/Plan Treatment included: water Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Exam is stable/unremarkable. VS improved. Pt monitored for 20 minutes. She feels well. Possible more likely anxiety related than a local reaction. Pt aware to monitor and follow up with pcp if needed. Pt here with husband whom walked out with her. She declined wheelchair. She feels well. APRN Electronically Signed 2/25/2021 11:59 AM

Itching all over my body - arms legs back. Extreme itching hen starched causes swelling and/or hives.

1604 rt deltoid swelling raised area 2 in. in diameter no rendess/drainage ice pack applied new band aid applied 1620 swelling reduced pt left after visualizing and verbalizing no additional change or concern

IN 24 HOURS AFTER 2ND VACCINATION -, RED WELTS AND RASH ON TORSO (FRONT & BACK), ARMS, LEGS. SYMPTOMS STILL PRESENT ON 02/26/2021

Notified by patient that she had "an allergic reaction" to her first dose of the vaccine. "It happened a day later, but I don't know if it was the shrimp I had that day. I was flushed and I got welts, so I went to the urgent care. I was prescribed an Epi-pen by my allergist after following up with them. I feel comfortable getting the second dose." Pharmacist and vaccine clinic lead notified. 30 min after dose given, pt states, "My ears are feeling a little itchy." Vital signs @ 1002: BP 175/80 P 69 O2 97% Temp 98.3 F R 12. VS @ 1007: BP 165/79 P 64 O2 98% Temp 98.4 F R 14. 1015 Pt states, "I'm feeling better and my husband is at home to watch me. I think I was just nervous." Pt declines dizziness/lightheadedness upon standing and declines any itching after second set of VS. Educated pt on strict ER precautions. Pt verbalized understanding and was appreciative for visit.

Within one week of second dose vaccine, blue/pink colored "hematoma-looking" 'bruise' underneath the skin about an inch long and an inch wide appear on the same arm as the vaccine location. Painful to lay on, hurt when using the arm. Over the next week, site became red, elevated, hot, and painful (like it was on fire).

Awakened from sleep, extremely cold, teeth chattering and shivering at 02:30 Returned to bed covered up with more blankets. Upon wakening, felt felt totally exhausted and weak. I slept and took naps throughout the day. Some aches in the body and sore arm where injection was given. Continued to feel extremely weak and cold the next 24 hours. Felt better day after but still tired and weak. injectgion site reddened and sore. Injetion site still sensitive, rpink discoloration and lump under the skin

Redness, swelling, and warmth over the right deltoid area. States there is tenderness to the site as well.

Mild headache, worse than normal fatigue, stiff neck, muscle ache, hot flashes, flushed cheeks, itching. Rash to antecubital area of right arm starting on Sunday night.

Shortly after vaccination, upper legs felt weak and head felt as if she was "floating" similar to being put under anesthesia. Day 2 developed Redness and rash on chest and lower back. Day 3 developed a large cold sore on lower lip. Day 4 - 4 more cold sores on upper and lower lips. Day 5-6 fatigue. She was observed for an hour, offered water and juice following the vaccine and was released home.

Itching/both arms near her wrist area only were itching like crazy/her back was itchy; two red welts, almost like hives on her body; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN5318, expiry date: not reported), via an unspecified route of administration at left upper arm on 28Jan2021 17:30 at SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks. Medical history included ongoing macular degeneration and thyroid disorder. Concomitant medications included levothyroxine for thyroid and ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS). The patient got the vaccine on Thursday 28Jan2021. Thursday and Friday she was fine. However, Saturday morning (30Jan2021) when she woke up she had two red welts, almost like hives on her body and a little bit of itching. Then, the wee hours of yesterday morning (Sunday morning) both arms near her wrist area only were itching like crazy. She was calling to see if it would be okay to take Benadryl for the itching. No one she has called yet has been able to answer her question. She tried contacting the hospital where she got the vaccine. The patient further reported that she noticed the two red welts like hives on her body on Saturday in the morning (30Jan2021) when she woke up, exact time not specified. This has gone away. It went away sometime yesterday (31Jan2021). These were also itchy. She noticed the inside of her arm by the wrist area in the early morning hours yesterday were extremely itchy. She thought for sure she would wake up with red welts but there wasn't any. Her arms are fine. Now, her back was itchy. Her back now was the only thing now really itching. She placed Cortisone cream on her back and it helped. Her back was still a little itchy, but not as bad. The patient scheduled for her second dose on 18Feb2021. Therapeutic measures were taken as a result of itching/both arms near her wrist area only were itching like crazy/her back was itchy. On 31Jan2021, the patient recovered from "two red welts, almost like hives on her body" and was recovering from itching.

Pain; Burning sensation; Hives; Injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female 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 the left arm, on 19Jan2021 14:50 at a single dose for COVID-19 immunization. Medical history included lymphoma from May2020, had chemotherapy for lymphoma from Jun2020 to 08Oct2020, shingles, knee replacement from 2008 and allergic to penicillin. The patient's concomitant medications were not reported. Patient stated she thinks she was having side effects from the Pfizer COVID-19 vaccine she got 19Jan2021, tomorrow 02Feb2020 was two weeks from when she got it. Patient didn't have any side effects to start with, just soreness to the injection site on Jan2021. She says last Wednesday, 27Jan2021, she noticed she had hives, not a rash, on her chest on the left side that are kind of on her breast, the top of her breast, which now spread under her arm up to her shoulder area and back. There was pain along with it, a burning sensation starting last night on 31Jan2021 in the inside area. Since she got her injection on her left side, she doesn't know if this could be a reaction to the injection or not. She had shingles several years ago, this was acting like that, and it looked like one of the side effects listed is lymphadenopathy, which she looked up information about that, but she doesn't know what it was, she doesn't know what else to blame it on. Patient hasn't seen her doctor yet for hives, and has not treated the hives. She got the OK from the nurse who said she didn't see a reason for her not to get the vaccine since she was coming off chemo several months prior. Patient was considered to be in remission right now, and she has an appointment next week with her oncologist for follow up. Outcome of the events was unknown.

Hives; itching throughout her body; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982), intramuscular on the left arm at the age of 77 years, on 27Jan2021 11:30 at a SINGLE DOSE for covid-19 immunization and cefuroxime axetil (CEFUROXIME AXETIL), oral from 25Jan2021 to Jan2021 at 250 mg, 2x/day (250mg tablet, one tablet twice a day by mouth ) for urinary tract infection. Medical history included ongoing diabetes mellitus diagnosed many years ago, ongoing rash because she was still having a problem in her pubic area with a rash that is going on, states this is from the urinary tract infection and urinary tract infection from an unknown date and unknown if ongoing. When she got the vaccine she was on an antibiotic for a urinary tract infection (UTI), she is asking if there would be any correlation or any interaction between the antibiotic and the vaccine. The antibiotic was something she has taken quite often and has taken it before called cefuroxime axetil. Concomitant medication included insulin (INSULIN) for diabetes. The patient developed itching throughout her body, like hives that started late Friday (29Jan2021) and she will get areas on her hands and arms. This morning it was on her legs where it was red and warm. She reported it goes away and comes back. This morning the hives were fairly heavy and now that she has gotten up and cooled her body down, the hives were subsiding. The outcome of the events was recovering.

RN-reports local reaction of pt at injection site. RN- assesses injection site and ask pt to be further evaluated in treatment area. Pt refuses to have vital signs taken and only requests to be given cold compress. Cold compress applied at injection site and pt continued remainder of recovery in general recovery area.

Patient states she reacted immediately after receiving the vaccine. States that she felt dizzy & light headed, her BP went up to 163/90 and she had tingling in her feet "as if I were wearing tight compression socks". Medical record indicates that she called 911 the day after her vaccine & reported dizziness & slurred speech. She was told to go to the ER, but did not go. She reported to her PCP's office that she had arm itching, she was anxious & fatigued as well. She also reported that she "felt funny in the back of her throat" & seemed to be coughing more. Headache also reported.

Patient developed a rash that occurred 2 days after administration. Patient woke up 2 days later extremely itchy and a rash localized on the right arm which was the one where the vaccine was given. Rash is improving today 3/5 but still present. No severe side effects noted.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient reports fatigue, myalgias, chills, and a swollen arm (at injection site) starting one day after receiving vaccination. Patient previously had COVID-19. During clinic visit three days after vaccination symptoms have resolved without intervention.

injection site pain; Nausea; fatigue; joint and muscle pain; joint and muscle pain; headache; chills; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201), via an unspecified route of administration on 20Feb2021 at 08:45 at a single dose in the right arm for COVID-19 immunization. Medical history included stage 4 breast cancer and thyroid cancer. Concomitant medications included levothyroxine sodium (SYNTHROID) and lorazepam. The patient previously took sulfur and experienced allergies and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 21Feb2021 at 04:30, the patient experienced injection site pain, nausea, fatigue, joint and muscle pain, headache, and chills. The patient did not receive any treatment for the reported events. The patient underwent lab tests and procedures which included Nasal Swab/COV-2 RNA (RT-PCR) NAAT with negative result on 09Oct2020. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.

Patient reported having red, itchy rash 7 days post vaccination. Upon return for 2nd dose, still had rash on chest. Patient reports using OTC cream for itching. Medical Team consult, determined that patient was unable to receive 2nd dose Pfizer today and will wait at least 28 days and until rash is gone. Also referred for possible Jaansen vaccine.

ct reports having fever, body aches, stomach pain with nausea and diarrhea, palpations, rash on her face, vision problems

Hives and welts appeared on various body parts, such as elbow, hands, around the knees, hips and more. I've been treating them with hydrocortisone cream, calamine lotion, and diet. They are getting better, however some still pop up. 2 dosage of the vaccine was Feb. 15, 2021. This report is March 10, 2021. I am still getting some hives and welts; others are starting to disappear.

Pt states she developed swollen lymph nodes under her left armpit towards her breast. The next day she had a itchy red rash at the injection site. Pt contacted her PCP and she was told to keep an eye on it and make a VEARS report since she had a reaction to taking the vax.

March 3, 2021-Sore injection site of right arm March 4th- Injection site slightly sore March 5th -sore left calf March 6th- Sore left calf a little more so March 7th- Outside left calf hot to touch & back of calf red and sore. March 8th- Same as above, and I put doterra Deep Blue ointment on it, and it relieved the heat and pain Redness is gone March 9th -Left side of body joints ached. left calf aches/applied Deep blue ointment and a Pain relief ointment . Feels a lot better March 10th- Redness gone, but still feels sore March 11th- Left leg Calf feels a lot better, I put on the ointment again. Deep Blue, and Frank Woods Pain Relief ointment. March 12- Left calf a little sore. No heat . Now my left eye has a light grey spot in it. I can see around it. March 13-Eye's don't feel right. I still have the light gray floater in the left eye.

Soreness, bright redness, and slight swelling for five days. Applied antibiotic cream and it took three more days for symptoms to disappear.

severe redness in upper arm, throbbing in wrist traveling upward to upper arm. Loss of strength/grip in arm/hand.

sore at vaccination point; tightness and heaviness in chest about two hours following injection, lasted about two minutes.

Rash all over her body her back and front; some pain in her stomach; This is a spontaneous report from a contactable consumer (patient's husband). A 77-year-old female patient received her second dose of bnt162b2 (BNT162B2 reported as Pfizer COVID-19 Vaccine; lot number: EL9269; expiration date: unknown) at 77-year-old vaccination age via an unspecified route of administration on 07Feb2021 at a single dose for covid-19 immunisation. Medical history included prediabetes and slight blood pressure or something (blood pressure abnormal). Concomitant medication included hydrochlorothiazide and unspecified medication (reported as she takes all kind of medications), all on an unspecified dates and indication. The patient received her first dose of bnt162b2 (BNT162B2; unknown lot number and expiration date) at unknown vaccination age via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The reporter inquired for his wife because her body now. They had the second shot on 07Feb2021 (Sunday) and he wonder how many days it takes after the shot to have side effects. She has rash all over her body her back and front on Feb2021 so he wonders if the shot could cause that. They had the vaccine given to them in a hospital. The reporter mentioned that she just a blood test (unknown results) on the 8th Monday (08Feb2021). She went to the ER (emergency room) in the same hospital. They did the whole work/lab work (unknown results) because she had some pain in her stomach on Feb2021. The outcome of the events was unknown.

Pt reported facial itching and trace throat tightness post-injection at 11:10 am. Given 25mg Benadryl PO and symptoms resolved with additional monitoring time.

Painful Headache; Arm where I received the vaccine is still sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of BNT162B2 (COVID-19 Vaccine, lot number: EL9264), via an unspecified route of administration, administered in upper left arm on 09Feb2021 (at the age of 77-year-old) as single dose for COVID-19 immunization. Medical history was none. Concomitant medication included vitamins (unspecified). The patient called to report that with the second shot, she experienced painful headache for 6 day no its more than 6 days and everyday she woke up with a horrible headache and this never happened before so she was assuming its because of that shot. She still has it and have been up already for four hours and already took two Tylenol (treatment). Also, her arm where she received the vaccine was still sore. The events occured on 09Feb2021. The outcome of the events was not recovered.

Developed petechial rash within few days of receiving 2nd dose on bilateral lower legs. Also had complaints of tremor, weak voice and cough with deep inspiration. Appeared to be developing cellulitis to bilateral lower extremities- treated with oral antibiotic. Oxygen level was good in office, advised to monitor for worsening.

She had no appetite; She was very tired; a headache and an upset stomach; vomiting; a headache and an upset stomach; sore arm at the site of the injection; This is a spontaneous report from a contactable consumer reported that: A 77-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 25Jan2021 (Batch/Lot Number: EL3302; Expiration Date: 31May2021) as single dose for covid-19 immunization. The patient medical history was unknown. The patient's concomitant medications were unknown. Caller is calling to see if anyone experienced a reaction like a week after having the first COVID shot. She says she didn't give it a thought because it had been a week, but her friend today suggested maybe she was having a delayed reaction. She received the shot on 25Jan2021, says she only had the sore arm on 26Jan and it was only at the site of the injection like a regular shot, and then last Monday evening 1Feb2021, she started getting headache and the next morning she felt miserable. On 02Feb2021, she had an upset stomach and was vomiting. She was very tired and that went on for a couple days. She couldn't get off the couch. She had no appetite. Gradually she got a little better and she texted the doctor's office they suggested she go. they could make her an appointment 25 minutes away to get a COVID test. She was not feeling like driving or riding in the car to get it. Or they suggested that she quarantine for 10 days which is what she has been doing. She is feeling just about back to herself, but she was curious if that could have been from the shot or maybe she just had some other bug. She thinks she was 143 last time a few months ago. The upset stomach and vomiting last also on the 03Feb which made the headache better. She says headache is gone but her head still feels little not quite itself, but the headache is gone. She says the upset stomach and vomiting have recovered completely. The tiredness is ongoing but is much better. She has not had anything else happen and she has had not been around anybody with who was sick unless they were asymptomatic and that would have been only a very few people. She wants to know if it is possible that the vaccine caused a side effect to show up 8 days later. She does not see NDC on her vaccine card. She provides lot number expiration from her vaccine card. Outcome of the events headache, tiredness, she had no appetite were recovering. Vomiting and upset stomach were recovered.

2/28/2021 DAY OF INJECTION #1 - HEAVY SENSATION IN UPPER LEFT ARM, LASTED LESS THAN 24 HOURS 2/18/2021 DAY OF INJECTION #2 - MILD SORE UPPER LEFT ARM RADIATED TO LEFT SHOULDER BLADE, USED TOPICAL ARNICARE FOR THE SORENESS WHICH LASTED ABOUT 24 HOURS 3/21/2021 VERY SORE UPPER LEFT ARM, SUDDEN "CHARLIE HORSE" RADIATED FROM THE INJECTION SITE TO THE LEFT SHOULDER BLADE, LUMP/KNOT UNDER THE INJECTION SITE ABOUT THE SIZE OF A WALNUT, USED ARNICARE AND MASSAGE, NO RASH OR VISIBLE BRUISING, SORENESS LASTED SEVERAL DAYS

Experienced soreness at injection sight, slight headache, fatigue, chills, weakness in legs, indigestion (sour stomach). I was diagnosed with having Covid-19 on Nov. 9, 2020. I had a mild/moderate case which lasted over 2 weeks. After receiving my first dose of the vaccine in the morning, I started experiencing the same symptoms (in the evening) that I had when I had the actual virus. One week later, I'm feeling better.

Red whelp developed at injection site approximately 24 hours ago, it was approximately a quarter in size and has progressed to redness down the arm. site is red and tender to the touch. The patient has applied an ice pack to the area.

Hives on various areas, mostly on forearms. A few on neck, legs, back, hands, wrists. The bumps range in size from marble size to quarter size and severely itch. I take Benadrel orally and apply Calamine lotion on bumps. I am currently still having hives.

facial flushing and redness, mild swelling. No shortness of breath or itching. Started within 1-2 minutes of receiving vaccine Treatment: Benadryl 50mg IM within 5 mins of reaction onset. Observed for 30 mins; feeling better; sent home; advised to call 911 if recurrent or new symptoms

severe pain emanating from injection site; traveled upward over shoulder; continued up right side of neck; heavy right earache; sore throat; headache forehead and across top of my head; dry heaves; feverish/chills/shivering; feverish/chills/shivering; words mixed up; Felt pain in center chest; congestion across bronchial area and developed upper respiratory congestion temporarily; congestion across bronchial area and developed upper respiratory congestion temporarily; fatigued; had severe coughing spell which included choking and further nausea; had severe coughing spell which included choking and further nausea; severe nausea; Ripple effect across bridge of nose; strong metallic odor and taste within mouth; moving from back of throat and nostrils; it is both painful and difficult to raise my right arm very high; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6060, first dose) solution for injection intramuscular in the right arm on 09Mar2021 at 16:00 (at the age of 77-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included known allergies: yes. Concomitant medication included vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Mar2021 16:15, the patient had severe coughing spell which included choking and further nausea, ripple effect across bridge of nose, strong metallic odor and taste within mouth moving from back of throat and nostrils, it is both painful and difficult to raise my right arm very high. On 10Mar2021, the patient experienced dry heaves, feverish/chills/shivering, words mixed up, felt pain in center chest, congestion across bronchial area and developed upper respiratory congestion temporarily, fatigued. On 10Mar2021 03:00 the patient had severe pain emanating from injection site traveled upward over shoulder continued up right side of neck heavy right earache, sore throat, headache forehead and across top of my head. Unspecified treatment was provided for the events. The outcome of the events choking, coughing, nausea, ripple effect across bridge of nose, strong metallic odor and taste and smell, severe pain emanating from injection site upward over shoulder continued up right side of neck heavy right earache, sore throat, headache, dry heaves, feverish, chills/shivering, words mixed up, Felt pain in center chest, painful and difficult to raise my right arm very high, fatigued was not recovered. The outcome of the event congestion across bronchial area and developed upper respiratory congestion temporarily was recovering. Since the vaccination, the patient has not been tested for COVID-19.

Pain in left armpit and left breast. Entire left arm swollen and reddened. Upper arm covered with blue tiny veins extending into left chest area.

Presented to emergency department with complaint of shortness of breath and chest discomfort. She reports shortness of breath began last night. States shortness of breath is exacerbated with exertion. She also reports generalized chest discomfort with shortness of breath. Recently placed on an antibiotic on the 22nd for a bilateral lower leg skin rash. States dermatologist was unsure what kind of rash or what the rash is, so biopsies were obtained and patient is to return next Wednesday for results. Otherwise respiratory history has had asthma as a child but has not had any exacerbation or symptoms as an adult. She recently received her second COVID-19 vaccine. Denies palpitations, fever, chills, congestion or cough.

Itching followed by what resembles a shingles rash that began as patches on right arm and then continued spreading in strips down right arm, left arm, areas on torso especially back and continues spreading to this day. All rash areas continue to itch and have not healed. Yesterday PA prescribed Prednisone and Hydroxyzine HCL, which has somewhat helped with the itching.

numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; Dizzy; little taste in mouth; numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246) via an unspecified route of administration on 21Jan2021 (at the age of 77-years-old) as single dose for protection. There were no medical history and concomitant medications reported. The patient experienced Dizzy, little taste in mouth, numbness at injection area, swelling came back 1 week later, 4 inches and round in shape on 21Jan2021 and itchy in Jan2021. It was reported that the patient got her vaccination on 21Jan2021. When she got it, she felt a little dizzy, and a little taste in her mouth that disappeared. She did experience numbness at the injection area and swelling that disappeared after two days. Then, after one week, the swelling came back. She still has it. It is 4 inches, and round in shape on 28Jan2021. She wants to know if this is life threatening. Her next vaccine is on 12Feb2021. Her height has went down. She got it at the Hospital. She doesn't have a prescribing doctor. She experienced the dizziness and taste in her mouth occurred while in the recovery room, it lasted a couple of hours. The arm numbness and swelling started a few hours later and lasted two days. Right now it is itchy, but she tries not to scratch her arm. The initial injection wasn't itchy when she had the numbness and swelling. It was just numb and swollen the first time. This time, it is itchy and swollen. She got the vaccine because she wants to be safe, for protection. The patient underwent lab tests and procedures which included body height: her height has went down in Jan2021. The outcome of events, dizzy, little taste in mouth on 21Jan2021 and numbness at injection area on 23Jan2021. The outcome of swelling came back 1 week later, 4 inches and round in shape was resolving and was not recovered for event itchy. No follow-up attempts are possible. No further information is expected.

Patient potentially received higher than the recommended 0.3ml dose of the Pfizer vaccine. As of Sunday 4/4, patient reports soreness at injection site and fatigue.

possible Type 3 hypersensitivity (immune complex mediated) to Pfizer - facial swelling, peeling erythematous rash, eye swelling 2-3 weeks after vaccinations (twice).

Rash on hands, arms, face. Also, with the first shot had a dry cough about a week after the vaccine. Feeling like i might be getting a cough now.

fever up to 101 F; itching; severe head and spine pain; severe head and spine pain; Extreme fatigue; Erythematous; Loss of voice; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6201), via an unspecified route of administration in left arm on 12Feb2021 12:30 as single dose for covid-19 immunisation. Medical history included psoriatic arthropathy, basedow's disease, psoriasis. Concomitant medications included levothyroxine sodium (SYNTHROID) (MANUFACTURER UNKNOWN); estrogens conjugated, medroxyprogesterone acetate (PREMPRO) (MANUFACTURER UNKNOWN). The patient previously took fentanyl and experienced drug hypersensitivity and bnt162b2 (product=COVID 19, brand=Pfizer BioNTech, lot number=EL9262, administration date=21Jan2021, administration time=04:00 PM, vaccine location=Left arm, dose number=1). On 13Feb2021 06:30 and experienced fever up to 101 f, itching, severe head and spine pain, severe head and spine pain, extreme fatigue, erythematous. On an unspecified date in Feb2021, patient experienced loss of voice. 18 hours post injection, severe head and spine pain, extreme fatigue, fever up to 101 F persisting 36 hours. Loss of voice 96 hours later, intermittent fever. Erythematous, hot area, raised (size of an orange) with itching in the area persists. On 13Feb2021, the patient underwent lab tests which included body temperature: up to 101 fahrenheit (intermittent fever). The patient did not receive any treatment for the events. The clinical outcomes of the fever up to 101 f, itching, severe head and spine pain, severe head and spine pain, extreme fatigue, erythematous, loss of voice were recovering. No follow-up attempts are possible.

Hives - first on left arm then other arm, both thighs, torso to below breasts and down to knees. Started 1 hour after vaccination, continued to get bad for 1 1/2 hour more, took Benedryl and used B cream. Hives stabilized but remained for another hour and then slowly went away. 6 hours later there was still redness where the hives had been. I have photos.

Please see Temporary Vaers E-Report 308709. The severe Itchy burny skin rash that continued 21 days after the first shot became more severe after the second shot with a large area forming and growing across the whole lower back. It had dimensions of about 12 inches across and 8 inches high that became solid red. A spotted rash formed on the sides of the breasts and upper back. Topical steroids were used. To not interfere with the immunization , the dermatologist waited 21 days before prescribing a programmed decreasing regiment of Prednesone tablets. The rash subsided 6 weeks after the second vaccination.

site pain; tiredness; headache; unwell/sour gut; chills w/out fever; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first 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 10Feb2021 at 11:45(at the age of 77-year-old ) as a single dose for COVID-19 immunization. Patient medical history included asthma, some mild arthritis, osteopenia. Concomitant medications included Mometasone Furoate(ASMANEX) (MANUFACTURER UNKNOWN), Esomeprazole sodium (NEXIUM) (MANUFACTURER UNKNOWN), Montelukast sodium (SINGULAIR) (MANUFACTURER UNKNOWN), (FLUTICASONE), vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 16Feb2021, on the 2nd and 3rd day, the patient experienced site pain, tiredness, headache. On the 6th day, the patient experienced chills without fever, tiredness, unwell/sourgut, headache. The outcome of the events was Recovered on an unknown date.

Pt admitted to hospital on 3/4/2021 with Extensive DVT to the LLE. No history of cancer or thromboses. History of redness and swelling to entire left leg starting on 3/1/2021. Received Heparin infusion in hospital. Currently receiving Eliquis p.o. Pt also underwent trombectomy with iliac stent placement by IR.

allergic response to isopropyl alcohol in second dose of COVID vaccine; 1st dose last 22Jan2021 - 2nd dose was on 08Feb2021; 1st dose last 22Jan2021 - 2nd dose was on 08Feb2021; doesn't feel good; one heck of a temperature; By doing what she did, if that negated the COVID vaccine/ That's what she was afraid of; redness and swelling in her right arm; redness and swelling in her right arm; feeling hot all over the body; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 08Feb2021 at a single dose for covid-19 immunisation. The patient's medical history included weakened immune system because of the alcohol allergy (started while 19), and aches and pains. Concomitant medications were not reported. The patient received the first dose of bnt162b2 (expiry date May2021) for COVID-19 immunisation at the age of 77 years old last 22Jan2021 administered on the upper righthand arm later clarified as upper right arm; and she was still going through that systemic reaction when she had her first COVID vaccine. The patient asked on regarding how effective the vaccine was related to receiving steroid therapy. Patient was advised by doctor to go to urgent care to have a covid test to see if she and husband were exposed to covid before the vaccines kicked in. Patient stated that on an unspecified date in 2021, she still didn't feel well and was running one heck of a temperature (increased). Patient reported she had a severe allergic reaction to the vaccine. She filled out the forms. Patient felt like she should be put in the hospital. She has a horrific allergy to alcohol. Each time she receives an injection it gets worse. She knew when she received the second dose that the third ingredient was alcohol. She thought about was worse, the virus or the reaction. Within a minute of taking the vaccine she had a reaction. She reported it at the site and was watched for a half hour. Her question was "because she took prednisone immediately after getting the vaccine does that negate the shot?" She was not asked the name of the steroid that she took. She was taking prednisone 20mg, 2 tablets as soon as she gets a shot then 2 daily Monday-Friday. It was still going through her system and it was reeking havoc on her. If she goes to the hospital they will give her Benadryl and monitor her. Patient stated that on 08Feb2021, she had an allergic response to isopropyl alcohol in second dose of COVID vaccine. Patient stated that she had both COVID shots and had adverse reactions and took some medicine for the adverse reaction and now the patient was concerned it might mess with the shot, it might not work for her as it should. She knew that this was going to be a long process and she knew her allergies were rare, but they were there. She is allergic to isopropyl alcohol, even if it is in shampoos or liquid soaps, she gets reactions. She had her first COVID vaccine and she had her own hospital cleanser that she has with her at all times and she used it which was not a problem. For her second COVID vaccine, the nurse was naming the 3 ingredients that were in the COVID vaccine and asked if she was allergic to any. She said this last shot had alcohol in it, she sat with her husband next to her, and thought which was worse: getting COVID, the cases in the city are high, or having a reaction to the alcohol. She chose the latter. When it went into her arm she immediately knew she was getting a reaction. She had steroids with her just in case this happened. Each time the reaction happens, it gets worse. She said she sat for half an hour and has been on steroids until last Friday. She was supposed to be on them for days. On Friday, she was wondering if taking the steroids negated the effectiveness of the COVID vaccine and that's why she called in. She knew that this was rare and it was not something that the company going to say that the company know how to fix it. Patient worked in the health unit of a university as a hiring and firing people person. So, she was around it, but she was not a doctor or a nurse. So, she guessed the answer was no. Last week she received her second COVID vaccine. She said, she has got to get rid of 5 pounds, but it's harder to do that when you're older. She experienced the reaction from the isopropyl alcohol within her second dose of the COVID vaccine last week, 08Feb2021. She said she was still going through it and will for a while. When asked for the outcome, she said she couldn't answer that honestly. She said she didn't feel good (2021). Period. She knew that when she goes through this it takes, each time, an extra 4 to 5 days to get over it. When she got up this morning, she didn't feel good. Her husband asked if she wanted to go sailing, and she said not in 30 degree weather, but for her to say no to sailing, her husband knew she didn't feel well. She couldn't say worse, but she can say she didn't know how long it was going to be, which was scaring her. By doing what she did, if that negated the COVID vaccine, then lets go from there. That's what she was afraid of. When she tells people she is allergic to alcohol, and when it happens, they look at her like "nobody is allergic to alcohol." She is 77 and has the aches and pains of a 77 year old, which she hates. But she doesn't think there are related medical conditions to what she experienced. This (allergy to alcohol) started when she was 19 and it has gotten progressively worse. So she tries to be careful. She says this was her, not dumb, but her decision that she made and now she is concerned. She said no to any tests done. She had the immediate reaction and she knew what to do. Patient further reported that she has allergy to alcohol and had an adverse reaction after the 2nd shot due to alcohol swab and on an unspecified date in 2021, she experienced redness and swelling in her right arm and feeling hot all over the body. Patient asked if her doctor will prescribe Benadryl to manage my allergy will it affect the effectiveness of the PFIZER-BIONTECH COVID-19 VACCINE. Therapeutic measures were taken as a result of the event "allergic response to isopropyl alcohol in second dose of COVID vaccine". The patient did not recover from the event "allergic response to isopropyl alcohol in second dose of COVID vaccine". The outcome of the other events reported was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: Linked Report(s) : 2021167304 PFIZER INC

On April 12 a red burning rash appeared on face and scalp. Burning itching and peeling of face and scalp like a bad sunburn Went to dr on April 16 and was told it was psoriasis. Was given prescription cream for face and scalp. Condition resolved a few days later.

Experienced skin rash/Some of the rash showed up in new places like her trunk; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that: A 77-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E13236), via an unspecified route of administration, administered in left arm on 21Jan2021 between 10:15-10:30 (at the age of 77 years old) as a single dose for COVID-19 immunisation. The patient medical history included Allergic to Sulfa drugs. The patient is generally a veru healthy person, does not have diabetes, not overweight and exercises. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took historical vaccine of Flu vaccines, Hepatitis A and Hepatitis B, shingles shot (sore arm), pneumonia shots. On 22Jan2021 at 20:00 the patient experienced Rash: began night of 22Jan2021. Rash is migrating. Started around right armpit all around the edges. At the same time it was on the edges of her left armpit. Rash is still there, but faint because she has been taking this medicine. There are larger blotches now on her right shoulder, both breasts, upper thighs, and small places. Might be one starting on her stomach. The patient visited dermatology doctor's office. The patient received treatment for the events with steroid creams: Fluocinonide Gel 0.5%, Clobetasol Propionate cream 0.05%, and Triamcinolone Acetonide cream 0.1% and Benadryl to lessen the rash. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

she noticed a lump surrounded by black and blue discolorations on the injection site of her left arm; she noticed a lump surrounded by black and blue discolorations on the injection site of her left arm; lump at site of injection; This is a spontaneous report from a contactable consumer or other non hcp. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200; Expiration Date: May2021), via an unspecified route of administration, administered in Arm Left on 26Feb2021 (at the age of 77-year-old) as single dose and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6208; Expiration Date: Jun2021)via an unspecified route of administration on 19Mar2021 (at the age of 77-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she had already completed her 2 dose series of the vaccine. After her first dose, she noticed a lump surrounded by black and blue discolorations on the injection site of her left arm. After her second dose, the lump on her left arm had develop some rash, swelling and itching and just went away after a week. On 08Apr2021, the lump looks like a teenager skin blemish that looks close to a large pimple. She also noticed that on the exterior of the skin, there was still minute reddish purplish discoloration and that the little lump was still there. She mentioned that she did not feel alerted and concerned because initially when she asked a nurse in the vaccination center, they mentioned that they have already seen side effects that looks like this. Now, she was just wondering if there was any reported events about this. Reporter stated that she got her first vaccine on 26Feb2021, that it left her with a kind of like a little lump at the site, tomorrow will be six weeks. Stated at the time it was surrounded by black and blue and that finally went away, exact date not provided. Left with the blemish, although it is a reddish mark lump. Got it over at the hospital. Seriousness of the events was not specified and was considered non-serious. The outcome of vaccination site lump and injection site mass was not recovered and vaccination site discoloration was recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

4/1 first shot: Broke out in a red rash upper body arms face 24 Hrs later after shower (hot Water). Went to skin Dr April 14. Have Triancinolone 0. 025% cream x 2weeks 2 x day plus Allegra AM & Zyrtec PM (Dr. said Dermatitis ). I am told reporting this??

itchy rash; eyes are itchy; blotches on both arms, under arms, some on her breasts, and buttocks, and some on knees and on her elbows; Rash; This is a spontaneous report received from a contactable consumer reported for herself. A 77-year-old female patient received first 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 15Feb2021 as single dose for COVID-19 immunization. Patient medical history and Concomitant medications were not reported. No other products or investigation assessment was reported. On 20Feb2021,the patient experienced itchy rash, eyes are itchy, rash, blotches on both arms, under arms, some on her breasts, and buttocks, and some on knees and on her elbows, stated her eyes were itchy and where the rash was itching. Age at time of onset of reaction/event was reported as 81. Stated that she was due for her second dose on 8Mar2021. Reporter wanted to know if the rash will happen again with her second dose. The patient was not recovered from the event. Follow up attempts are completed. No further information is expected.

Numbness and sensitivity on right side of face, nose, right nostril and upper lip; took Lyrica to see if this was a nerve issue; Numbness and sensitivity on right side of face, nose, right nostril and upper lip; took Lyrica to see if this was a nerve issue; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL7Z69 ; expiry was not reported) via an unspecified route of administration on 10Feb2021 as single dose for covid-19 immunisation (at the age of 77 years). The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced numbness and sensitivity on right side of my face, nose, right nostril, and upper lip; and she took Lyrica (lot number: 19074111; Investigation Assessment: No) to see if this was a nerve issue and as therapeutic measures. She took a Lyrica this morning (12Feb2021) to see if this was a nerve issue and she took a Lyrica, Saturday as well. She was just checking to see if she had numbness and sensitivity on the right side of my face and the nose, the right nostril, and the upper lip of the mouth, was this a cause of the shot and is this the reason of Covid or not. The outcome of numbness and sensitivity on right side of face, nose, right nostril and upper lip; took Lyrica to see if this was a nerve issue was unknown. Information about Lot/Batch number has been requested.

Started feeling like kind of small lumps in that muscle or little below; redness; Muscle soreness; itching; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6201, expiry date: unknown), via an unspecified route of administration on 06Feb2021 (at the age of 77-years-old) at a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included DILTIAZEM. Patient stated I take Tiadylt and it is, I think maybe to dilate blood vessels and rest of the stuff is over the counter. The patient received the vaccine on 06Feb2021 and experienced some muscle soreness. Patient stated, I just wanted to report that I received a Pfizer Covid vaccine on February 6th and experienced some muscle soreness. But on the 12Feb2021, I started feeling like kind of small lumps in that muscle or little below and some redness and by Saturday, redness was about three and a half inches in length and two inches wide and lumps are still there, you could see the lumps. Also, I could feel that knot, it is probably like an inch and a half big knot. I am just thinking if it was reaction. It itched a lot but I didn't really have any pain or discomfort with it, it just was red and little warmer to touch. No treatment was received for the events. The outcome of redness and vaccination site lump was reported as recovering, while the outcome of itching and muscle soreness was unknown. Follow-up attempts are completed. No further information is expected.

Mild sensation in left chest area and along left side neck, along with mild shortness of breath starting about 3/20/21 Has since disappeared. On or about 3/25/21 a hard, painful rash appeared on buttocks and has since healed. A second larger painful rash appeared in a different area on or about 4/5/21 and lasted about 2 weeks. Along with rash is tenderness of skin in surrendering area of rash, there is pain under breast area which extends to back and persists.

February 8th started right arm swelled up like a baseball bat for 3-5 days, went away after using ice pack. Symptoms came back around March 12th with rash on left arm, black and blue mark about 1-2 inches, no pain, lasted about two weeks. March 23rd had red 3.5 inch lesion, soar, painful, no itching.

SWOLLEN LYMPH NODES in Right armpit. Still have the swollen lymph nodes today 5/5/2021, almost 2 months. Frightening. Swollen under left eye 3/9/2021 to 3/11/2021. Upper back of both legs painful 3/9/2021. Still have this today 5/5/2021, almost 2 months. Sore at injection site 3/8/2021. Fatigue 3/9/2021.

Right eye pain with tenderness and blistering around the eye. Nose numbness on the right side of nose and around. Top of head sensitive. She went to the ED, which diagnosed shingles and referred her to the eye doctor. Prescribed 10 days of Valcyclovir, erythromycin opthalmic ointment, and prednisolone opthalmic suspension. Symptoms lasted the month of April.

abdominal discomfort; 3 itchy bumps also appeared in the left breast area; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01Feb2021 08:30 (Lot Number: EL9265) at single dose for COVID-19 immunization. Medical history included hypertension and irritable bowel syndrome (IBS), Shellfish allergy. Patient didn't have COVID prior vaccination. Concomitant medications included metoprolol succinate ER 25mg taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported. No other vaccines were administered in four weeks. After the shot on 01Feb2021, there was abdominal discomfort within 15 minutes. 3 itchy bumps also appeared in the left breast area. No treatment was received for the events. The outcome of the events was not recovered. COVID was not tested post vaccination.

Legs swelled up really bad ; it left blotches in my leg; Legs swelled up really bad ; it left blotches in my leg; Fever; Bladder infection; UTI; He gave me some medications and it is helping the rash; stomach even swelled up; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 77 years old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine information included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, for COVID-19 immunization, dose 1 on 17Jan2021 at age of 77 years old. On 23Feb2021, the patient experienced legs swelled up really bad it left blotches in my leg and she went to the doctor, she had fever, bladder infection and Urinary tract infection (UTI). The legs swelled up real bad, her thighs from the waist, she just swelled up everywhere. Her stomach even swelled up but the right leg mostly. She experienced the blotching, it looks like a birth mark on my right leg and the left leg. It is blotchy, looks like a birth mark on the legs. The right one got really big. She did go to doctor and he said it was not a blood clot. He said people are getting swelled up with rash, some people are having rashes and swelling. Treatment included the physician gave her some medications and it is helping the rash and "cephalexin 500 mg, 3 times a day" for the UTI. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

shingles; This is a spontaneous report from a contactable consumer (patient) reported that a 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265; expiration date: 31May2021), intramuscular, administered in arm right on 28Jan2021 16:00 (at the age of 77-years-old) as 1st dose, single for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included hysterectomy from 07Dec2020. There were no concomitant medications. Ten days later on 07Feb2021, the patient had onset of shingles. She was prescribed medication for shingles, and finished her last pill of that medication on 20Feb2021. She was scheduled to get her second dose of Pfizer COVID-19 Vaccine, and wanted to know if it would be ok to get that second dose relative to this event. She was scheduled to get her second covid-19 vaccine dose on the 11Mar2021. The clinical course of patient's shingles was described as all the bumps that she did get have dried except for one little spot; it all was on left side of head and face and it seems to be pretty much gone. One little sensitive spot remains where it first began back on the crown of her head on the left side. The itching is gone. The areas on the scalp and forehead have dried up, although there is still a little bumpiness but no itching or burning or anything like that. It's been an ordeal. She does feel like her doctor got her treated quickly and the medication was effective; the shingles was not as severe as some shingles cases can be. The event 'shingles' resulted in physician office visit. The patient underwent lab tests and procedures which included blood test: everything looked good on 22Feb2021. The outcome of the event was recovering.

Headache, lethargy, nausea, fever for first three days then rash covering all extremeties and abdomena nd chest

Injection site swelling about 3" diameter, warm, hard and itchy; Injection site swelling about 3" diameter, warm, hard and itchy; Injection site swelling about 3" diameter, warm, hard and itchy; Injection site swelling about 3" diameter, warm, hard and itchy; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 06Feb2021 11:15 (Batch/Lot Number: EL9264) as single dose for COVID-19 immunisation. Medical history included Asthma, Hypertension, Thyroid, high cholesterol, Chronic obstructive pulmonary disease (COPD), patient had allergy to Penicillin. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); simvastatin (SIMVASTATIN); losartan (LOSARTAN); ibandronate sodium (BONIVA) and gabapentin (NEURONTIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (lot number= EK4176) in the right arm on 16Jan2021. No covid prior vaccination. No covid tested post vaccination. On 07Feb2021, 06:00 AM, the patient had injection site swelling about 3" diameter, warm, hard and itchy. Hasn't gotten better in 4 days. No treatment received for AE. Outcome of the events was not recovered.

April 14 pain in side of face; next day watery eye and rash above eye. Clariton D and advil helpful; April 27th am pain on top of left side of head and face and over eye. Urgent care diagnosis shingles with eye complication; ER tested and then treated me for shingles. One week anti viral with f/u with ophtalmalogist and internist. Antiviral extended one more week and cortisone and triple for eye area. I am still doing the lotion treatment and have gone back to eye doc twice and tomorrow again. Tylenol 3 time a day. I have since come down with a cold but getting over that. It appears pfizer vacine has weakened my immune system for these other diseases.

became extremely dizzy; when I came home and passed out.; Hit my head on floor; received a concussion; cut on scalp; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 15Mar2021 13:45 (at the age of 77-year-old) (Batch/Lot Number: en6205) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient had no relevant medical history. The patient had no known allergies. Concomitant medications included atorvastatin; furosemide; and calcium. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: el9265), administered in left arm on 22Feb2021 at 02:30 PM (at the age of 77-year-old) for COVID-19 immunisation. On 15Mar2021, the patient became extremely dizzy when she came home and passed out. She hit her head on floor and received a concussion and cut on scalp. The events caused hospitalization for 2 days. The patient was tested for COVID post vaccination via nasal swab on 22Apr2021 which was negative. Therapeutic measures were taken as a result of all events which includes computed tomography (CAT) scan and electrocardiogram (EKG) with unknown results. The patient recovered from the events on an unspecified date.

nauseated; upset stomach; itching all over her body; threw up at breakfast; Headache; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number EL9265, Expiration date: unknown), dose 1 via an unspecified route of administration on 28Jan2021 as 1st dose, single for COVID-19 immunization. Medical history included ongoing blood pressure and acid reflux. Concomitant medication(s) included vitamin c, VITAMIN D3, calcium, zinc, blood pressure medication and acid reflux medication. The patient did not want to take the vaccine but her son insisted she took it so she went with him. The patient reported that she got the first dose of the vaccine and she did not think she paid much attention that day. The first day the patient threw up at breakfast and felt real nauseated then continued to have nausea with an upset stomach all day long and she did not know if that was making her headache or what, but she was nauseated all day long. The second day, she had a stomach upset. She went out that day and came home. She could not remember if she ate anything or not but then the next day she got nauseated with an upsets stomach. One night, she had itching all over her body then she feels like just blah. She took a Benadryl toward the morning because she could not stand the itching and thought if it was some type of allergy or something, maybe it could cut it down and she finally got to sleep. She wanted to know about the second dose because she heard a lot of people were super sick with the next vaccine and if she was having problems right now, whether she should take the another one. She saw the date range 17Feb2021-24Feb2021 and COVID 19 vaccine. She regularly took a blood pressure medication and an acid reflux. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

headache; tiredness; got sleepy; felt a little bad; cysts bleeding; breast pain; knot in the vaginal area right in the fold of pelvis and thigh inside of the pelvis that was painful; cysts in the rectal area; rash on her face and it's itching/ rash started in her face and ear, all on the left side, on her ear half way down the outside of the ear; soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 12May2021 11:30 (Batch/Lot Number: EW0168) as 1st dose, single for covid-19 immunisation. Medical history included acne and migraine. The patient's concomitant medications were not reported. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 12May2021, patient experienced soreness in arm. On 13May2021, she had symptoms of rash on her face and it's itching, and the rash started in her face and ear, all on the left side, on her ear half way down the outside of the ear. She could see all the pimples on the face so she put hot water on it and used rubbing alcohol, which she thought would help curb the itching and dry it up, the bottom of the ear lobe is very much active going into jaw area still. She also had headache, and tiredness following her dose, the doctor told her if headache was severe, take a Tylenol with codeine, she took something with codeine and it went away after about three hours. She also had some breast pain (only in the enfold of her breast closest to the middle of her chest), sore to the touch, and it was very sore for about 24 hours, and that it hasn't fully resolved. Then, while bathing, she noticed a knot in the vaginal area right in the fold of pelvis and thigh inside of the pelvis that was painful, large, and the size of a quarter, if she push on the pelvic bone area, it would be painful. Also, while bathing, she identified cysts in the rectal area; after bathing she was trying to identify what they were, when she touched it, it hurt, it felt like a ball and eventually it went down and she caused them to bleed, not a lot of blood, just a small amount. She also started getting more growths in the vaginal area/bottom area near the rectum. Patient got sleepy and now made herself go lay down and she doesn't usually do that. She felt a little bad, she didn't think it was severe side effects, she knew things were going on that she could pinpoint to what would possibly happen but not these cysts. She was recently seen by her gynecologist, a week ago, and none of these problems were apparent at that time. No Emergency Room or Physician Office visit. Patient had blood work done on 07Apr2021 and 10Apr2021 before the vaccine. The outcome of cysts bleeding and soreness in arm was recovered on 13May2021, itching rash, breast pain, painful knot, cysts in the rectal area was recovering, headache was recovered, other event outcome was unknown.

redness below injection site; upper arm at injection site feels heavy and tight; This is a spontaneous report from a contactable consumer (reported on herself). The 77-year-old female patient received BNT162B2 (Solution for injection, Lot number: EN6200 expiry date: unknown) via an unspecified route of administration in left arm on 23Feb2021 9:58 am, as a single dose for Covid-19 immunization. Medical history included Diabetic since in her 30's or 40's, and problems with her spine. Concomitant PIOGLITAZONE HYDROCHLORIDE (ACTOS) 15mg daily Ongoing for Diabetes has been taking for over 10 years, HYDROCHLOROTHIAZIDE, TRIAM-TERENE (TRIAMTERENE/HCTZ) 37.5mg/25mg daily Ongoing had been taking for over 10 years for high blood pressure, LISINOPRIL 40mg daily ongoing for Blood pressure taking for over 10 years, ALENDRONATE SODIUM 35mg every Saturday from 2018 Ongoing) for bones. She would receive injections (unspecified) for back. She had one just before Covid but has had none since. She had problems with her spine. She had inflammation of the spine. She was unable to pronounce the name. On 23Feb2021, everything went ok. She waited for 15 minutes after she received the vaccine. When she got home there was a big red spot the size of a nickel down below the injection site. It had faded. She does not recall hitting her arm. The paper that they gave her mentions redness and a rash. This was down below the injection site. The redness had gone away. It looked like a bruise that had changed back to her skin tone. She could see blotches of the redness. It was a dark color but not bruised. Her upper arm felt heavy and tight. She did not have history of previous immunization with the Pfizer vaccine considered as suspect or additional Vaccines Administered on Same Date of the Pfizer Suspect. Events did not require to visit Emergency Room/ Physician Office. She did not receive prior vaccinations (within 4 weeks) and no relevant tests were performed. Outcome of the event of redness below injection site was recovering, however outcome of the event of upper arm at injection site feels heavy and tight was unknown. No other information was reported.

Arm is like bright red in that area and it's warm; arm is like bright red in that area and it's warm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6204), via an unspecified route of administration on 27Feb2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On an unspecified date (a week since vaccination), patient still had her arm was like bright red in that area and it's warm. Patient saw it was even listed as one of the side effects and she was wondering whether this was okay and how long that would last. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

my chest to all the way up to my neck was brilliant, brilliant red and felt like really hard sandpaper; my chest to all the way up to my neck was brilliant, brilliant red and felt like really hard sandpaper; around my neck 2 long red lines, It looked like someone is trying to strangle me; my whole body got covered in little red spots, and then slowly it started to peel off and the peeling was even on top of my hand; when as far as the top of my neck where the chin starts because I thought oh my god it has got my face too but it stopped their but everything else is got it; I am still peeling, my rear end is still peeling skin off, It's like big sheets coming off, It's like big sheets coming off/skin is still 'fluffing' off; It scares the hell out of me; This is a spontaneous report from a contactable consumer (Patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for Injection; Lot number: EW0753; Expiration date: unknown), via an unspecified route of administration on 29Apr2021 (at the age of 77-year-old) as 2nd dose, single dose in left arm for COVID-19 immunisation. The patient's medical history included surgeries. 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: EW0173), as single dose for COVID-19 immunisation. On unspecified date in May2021, a few days later after second dose, the patient's chest to all the way up to neck was brilliant, brilliant red and felt like really hard sandpaper, and around neck 2 long red lines, it looked like someone was trying to strangle. The patient went to the dermatologist, they did not know what it was, and they sent the sample out. In the meantime, the patient's whole body got covered in little red spots, and then slowly it started to peel off and the peeling was even on top of the hand, the patient still peeling, her rear end was still peeling skin off, It was like big sheets coming off, It scared the hell out of her, she did not know what was going on. Patient just told that no one else was having that kind of reaction that she had. It really scared her when it reached this far on the top of her neck where the chin starts because she thought oh my god it has got on the face too, but it stopped their and everything else got it. The first symptom was on her chest and that became brilliant red and looked like she was on fire and that was just as hard as a sandpaper. That was the first thing and slowly other things started, that brilliant red start and her body all started coming out with red spots. It did not itch and slowly it started to 'fluffing' off and the skin was still 'fluffing' off. Patient had the second vaccine almost a month ago. On the top of her hand there was peeling. It scared her to death because this thing has not been happened it was 6 months and she do not know why she got it and really do not know. She just wanted to report because she went to her own doctor and then to dermatologist. The clinical outcome of the events was unknown. Follow up needed, further information has been requested.

Pain on left side with tingling, Shingles, Antiviral Valtrex, Nerve pain Gabapentin, and Zyrtec for treatment.

Soreness at injection site (3 days) Swollen lymph glands (2 days) Lethargy (2 days) Fever spikes (day following shot) Brain fog (2 weeks) Achiness in shoulders & neck (2 days) Diarrhea (2 weeks - ongoing)

she had 5 days of exhaustion where she felt like she couldn't get out of her chair; she was also very aware of her stomach; two twinges in her arm; she couldn't even stand clothes on her legs; skin on her left leg started to hurt so much that it reminded of her of having a neuralgia; She had stinging on the top and behind her knee and it traveled down towards her ankle and up towards her upper thigh/stinging in certain parts of her leg; skin on her left leg feels burning; left leg felt like it needed cold and not heat; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0178; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in left arm on 25May2021 at 14:30 (at the age of 77-year-old) at a single dose for covid-19 immunisation at Clinic. Medical history included ongoing high blood pressure, high cholesterol and it runs in her family (She has tried all the different "statin" medications and she couldn't tolerate any of them. Her cardiologist told her there was an injection she could take for her cholesterol every two weeks and it was supposed to be like a "liquid plumber" for your veins. She is so sensitive to medications including all these "statin" medications, there is no way she can take the bi-weekly injection. It might have a much more profound negative affect on her. She was so leery of taking medications, even over the counter medications), gastrooesophageal reflux disease (GERD), 4 cardiac stent placements in 2015, blood pressure abnormal, allergies (unspecified), sinus are swollen, neuralgia, cataract surgery (a year and half ago), retina had swelled and sensitivity to heat. Concomitant medications included acetylsalicylic acid (ASPIRINE) chewable tablets at a dose of 81 mg daily for sinuses are swollen (her sinuses are not swollen at this time), loteprednol etabonate (LOTREL) for blood pressure abnormal. The Lotrel keeps her blood pressure around 120/70mmHg, famotidine (PEPCID) for gastrooesophageal reflux disease. The patient previously took tylenol and experienced allergy and giant hives. Aspirin give her hives but usually a hive here or there, not real big hives, ilevro for retina swelling and affected her skin on her face (She did have a problem while she was taking the steroid eye drops. They made her feel very unwell. She does not take Prednisone for the same reason. She had tried many different steroid eye drops and so many of them gave her a problem. She ended up taking Ilevro. She had no choice but to take it. The Ilevro affected the skin on her face. Her retinas had to stop swelling. Everything is fine now. She has no glaucoma or macular degeneration. This occurred a year and half ago when she had her cataract surgery). She had given the nurse who gave her the injection a list of all her allergies and sensitivities and the nurse reviewed the list and didn't see anything in the Covid 19 vaccine that would cause the caller harm based on her list of allergies and sensitivities. The caller took a deep breath and prayed while she received the Covid 19 vaccine. After the vaccine she waited at the facility and she was fine and then she left to go home. She ever had an adverse event with any other vaccines she reports she has not been vaccinated with anything since she was a child. She didn't even have the Polio vaccine. The patient did not receive any other vaccinations within four weeks prior to the first administration of the suspect vaccine. After getting the Covid 19 vaccine, on an unspecified date, the patient had 5 days of exhaustion where she felt like she couldn't get out of her chair and she was also very aware of her stomach. Her stomach wasn't upset but she was aware of it. That slowly passed and she started doing the things she needed to do. She needs to walk because of her heart stents. She had been fine after the Covid 19 vaccine until last night on 10Jun2021 at 21:30 the patient skin on her left leg started to hurt so much that it reminded of her of having a neuralgia. She provides an example of her sometimes feeling a draft and she can develop a neuralgia from the draft for a day or two. That's what her leg felt like initially. As the night wore on, around 22:00, she realized she couldn't even stand clothes on her legs. She wears nightgowns, not pajamas and she had to take her nightgown off her leg. The sensation in her leg started changing, she could feel that she not only had the skin hurting sensation but now she had stinging in certain parts of her leg. She had stinging on the top and behind her knee and it traveled down towards her ankle and up towards her upper thigh. It was bizarre. She thought about it this morning, 11Jun2021, what it felt like. She remembered way back, long ago, and she was not a sun person, but it felt like how a sunburn would feel. The skin on her left leg feels burning. She used Aspercreme on her leg thinking it will help with the pain. She wiped all the Aspercreme off her leg. She could not cover her left leg. Her left leg felt like it needed cold and not heat. She does have a history of sensitivity to heat. She runs her air conditioner, and she had a ceiling fan above her bed. She had her left leg exposed and out of her bed covers to try and get the cold air on her hot leg. Finally, around 23:30, her leg still bothered her, but she was able to go to sleep. She twisted and turned at night but was finally able to put her bed cover back on her leg but lightly. The sensation was still there in her leg. She was so sensitive. On an unspecified date, the patient had two twinges in her arm and then her arm never hurt again. The events did not result in emergency room or Physician Office. She is due for her second Covid 19 vaccine on 15Jun2021. The outcome of the events she had 5 days of exhaustion where she felt like she couldn't get out of her chair, she was also very aware of her stomach, two twinges in her arm was unknown and the rest of the events was not recovered. Information on lot/batch number was available. Additional information has been requested.

getting a rash on her back; sore arm; She mentioned that she had a sore arm after the first shot; She was told by a nurse that she could take claritin, dimetapp, or tylenol before receiving her second dose, to help lessen the potential for side effects.; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265; Expiration Date: 31May2021)via an unspecified route of administration, administered in Left Arm on 28Jan2021 at 08:30 as First Dose, Single Dose COVID-19 immunization. The patient's medical history included shingles seven years ago, blood pressure abnormal, rheumatoid arthritis, hysterectomy at a young age and was put on Premarin. She was on a higher dose initially but is currently taking 0.3mg daily. When they have tried to take her off of Premarin she has a reaction. She is unsure if it is a reaction or mental. Product is filled in a pharmacy bottle. NDC, Lot and Expiry are not on the label. She has had shingles twice. Clarifies that her last episode was 10 years ago. She is due a Shingrix vaccine. Her physician says with her rheumatoid arthritis, taking Hydroxychloroquine and Covid he doesn't recommend that she get the Shingrix vaccine. No Patient's Medical History including any illness at time of vaccination. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN)Hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for blood pressure abnormal from 2011 and ongoing; hydroxychloroquine (HYDROXYCHLOROQUINE) taken for rheumatoid arthritis from Dec2019 and ongoing; estrogens conjugated (PREMARIN) taken for hysterectomy. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Prior Vaccinations within 4 weeks No Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient mentioned that she had a sore arm after the first shot from 28Jan2021 to 01Feb2021 and she was told by a nurse that she could take claritin, dimetapp, or tylenol before receiving her second dose, to help lessen the potential for side effects, she was getting a rash on her back from 04Feb2021 and ongoing. This started as a little circle under her shoulder blade. Is this a reaction to the vaccine or could it be shingles. No relevant tests were performed. The patient did not visit any Emergency or Physician office for the AEs. The outcome for the events was sore arm was recovered/resolved and the Rash was not recovered/not resolved and Unknown for rest of the events. Follow-up attempts are completed. No further information is expected.

Today whelps are fading, but light red; Itching; Was sitting on the sofa and it felt like something bit her/Awful; Whelps on back near shoulder and side of breast; Whelps very red, like blood red, raised; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient) reported that a 77-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL8982), dose 1 via an unspecified route of administration, administered in Deltoid Right on 27Jan2021 14:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included heart surgery from 17Mar2020 to an unknown date. There were no concomitant medications. Patient did not had family medical history and illness. Patient did not had any history of previous immunization. On 04Feb2021, the patient experienced Whelps on back near shoulder and side of breast; Whelps very red, like blood red, raised; Itching and was sitting on the sofa and it felt like something bit her; On 05Feb2021, Today whelps are fading, but light red. Patient did not performed any relevant test. Patient took COVID vaccine because she wanted to be protected from the virus, it was awful. It was reported that caller reports she had the COVID shot on 27Jan and everything was fine. Yesterday she had some whelps on her back near the shoulder and on the side of her breast. It was so very red, like blood red yesterday and itching. Today they are fading, but are light red. Yesterday she was sitting on the sofa and it felt like something bit her. Then she noticed the whelps and they were raised. Still has a few on the breast and one almost on the dark area near the nipple and still itching right now. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. They called her to come get the vaccine due to her age group. Patient had no AE prior vaccination. Patient was not visited to emergency room and physician room. The clinical outcome of event Whelps very red, like blood red, raised was recovering; Was sitting on the sofa and it felt like something bit her was unknown; while all other event was not recovered. Follow-up attempts are completed. No further information is expected.

hard time walking; tiredness; foot swollen; foot hot to touch; Since receiving the vaccine she has been sleeping a lot for about 3 days; Foot pain; foot redness; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL9261)via an unspecified route of administration, administered in Left Arm on 02Feb2021 at 12:00 (at the age of 77-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included parkinson's disease, transient ischaemic attack, hypersensitivity, sinus disorder, Cardiac disorder, vaginal infection, pain, incontinence, antidepressant therapy, hallucination, unspecified vitamin D deficiency. No relevant tests done. The concomitant medications included ongoing estradiol (ESTRACE VAGINAL) taken for vaginal infection from 2019, ongoing colecalciferol (VITAMIN D 3) taken for vitamin d deficiency, ongoing pimavanserin tartrate (NUPLAZID) taken for hallucination from 05Feb2021,ongoing venlafaxine (VENLAFAXINE) taken for antidepressant therapy, ongoing carbidopa, levodopa (RYTARY) taken for parkinson's disease, ongoing mirabegron (MYRBETRIQ) taken for incontinence, ongoing atorvastatin calcium (ATORVASTATIN CALCIUM) taken for cardiac disorder, ongoing aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for transient ischaemic attack ,ongoing clopidogrel bisulfate (CLOPIDOGREL BISULFATE) taken for transient ischaemic attack, ongoing paracetamol (ACETAMINOPHEN) taken for pain, ongoing loratadine (LORATADINE) taken for hypersensitivity, sinus disorder, ongoing ascorbic acid, biotin, calcium, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, potassium iodide, pyridoxine hydrochloride, retinol acetate, zinc sulfate (CENTRUM MULTIGUMMIES WOMEN), amantadine hydrochloride (AMANTADINE HYDROCHLORIDE) taken for parkinson's disease. Since receiving the vaccine she had been sleeping a lot for about 3 days (on 03Feb2021). Caller stated she knew that was supposed to be a side effect. Adds her mother was a Parkinson's patient and usually able to walk using a walker. She was having a hard time walking (03Feb2021) and had to use the wheelchair. Clarifies her mother started sleeping quite a bit about three days after the vaccine on Friday 03Feb2021. Mentions previous to this on Wednesday after the vaccine, her mother was complaining of foot pain (on 03Feb2021) towards the side midway on the foot in the arch and on the top where you tie your shoe. It was almost like she dropped something on it but she did not. It was slightly swollen on the top and red and warm (on 03Feb2021). Friday when her mother started sleeping so much, they had resort to the wheelchair. She took her to see the nurse practitioner on Friday for the foot, who sent her to the ER for an X-ray on Saturday so they went out again on Saturday to get the foot x-ray done. The foot was not broken. They did treat her mother's foot with Cephalexin. Her foot was fully recovered now. Her mother's tiredness (on 05Feb2021) was persisting and she was having a hard time just getting up from the bed and to go across the room even though the foot was fine. Today they have a message into her neurologist. Adds today was the first day her mother started talking about needing or wanting to go to the hospital for her tiredness and not being able to walk (06Feb2021) Her mother was scheduled for the next dose 23Feb2021.The patient underwent lab tests and procedures which included x-ray limb: the foot was not broken on. Therapeutic measures were taken as a result of foot pain, foot redness, foot swollen, foot hot to touch.The outcome for the events foot pain, foot redness, foot swollen, foot hot to touch was recovered/resolved on 08Feb2021 and not recovered/not resolved for rest of the events. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected

Itchiness on chest; rash on chest; Shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old non pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, in Arm Right on 24Feb2021 13:30 (at the age of 77 years old) (Batch/Lot Number: ERV6200) as single dose for COVID-19 immunization. Previously the patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration, in Arm Right on 04Feb2021 14:00 (at the age of 77 years old) (Batch/Lot Number: EL9264) as single dose for COVID-19 immunization. Medical history included trigeminal neuralgia. Concomitant medications included gabapentin; oxcarbazepine taken for an unspecified indication. The patient has no known allergies. On 24Feb2021 at 09:00 the patient experienced itchiness and rash on chest, Shortness of breath and self-administered Cortisone cream only on chest. No other vaccines were received in four weeks. The patient had no covid prior vaccination and was has not been tested for Covid-19 post vaccination. Therapeutic measures were taken as a result of itchiness and rash on chest, shortness of breath. The clinical outcome of the events was recovering. Follow-up attempts completed. No further information expected.

Flu-like symptoms; headache; Body aches; fatigue; in bed all next day; Left arm swollen; itchy at injection site; This is a spontaneous report from a contactable consumer. A 77-year-old non-pregnant female consumer (Patient) reported that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 30Jan2021 at 02:15 AM (at 77-year old) on left arm at dose 1, single for COVID-19 immunization. The medical history of the patient included that she was tested covid-19 positive. The patient had no allergies. The patient's concomitant medications were not reported. Patient had not received any Other vaccine same date and had not received other vaccine same date product. It was mentioned that patient got no other vaccine in four weeks and no medications in two weeks. On 30Jan2021, the same day patient had itchy at injection site; Monday he was site still itchy. On 31Jan2021 at 12:00 hours the patient experienced flu-like symptoms, headache, body aches, fatigue, in bed all next day after shot and his left arm was swollen. On 08Feb2021 the nasal swab covid test was done for which results was unknown. The patient was scheduled for 2nd shot on 20Feb2021. The outcome of injection site itchy was not recovered and outcome of other events flu-like symptoms, headache, body aches, fatigue, in bed all next day after shot and his left arm was swollen was unknown. No follow-up attempts were possible; information about Lot/batch number could not be obtained.

red blotch with lump on left arm, black and blue marks left leg, itchy little bumps, top left foot, very black and blue on top of right foot going on to toes took pictures on my cell phone

Redness, swelling and extreme pain. Started right after injection and it continues as of today. She was started on Keflex at first and is now on amoxicillin.

"rash on her stomach and bumps on the body but now went away" but she is still "itchy"/and chest with a few bumps; "rash on her stomach and bumps on the body but now went away" but she is still "itchy".; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 22May2021 (Batch/Lot Number: EW0172) as dose 1, single (age at vaccination 77-year-old) for covid-19 immunisation. Medical history included glaucoma from an unknown date. Concomitant medication(s) included dorzolamide hydrochloride, timolol maleate (COSOPT) and brimonidine tartrate (BRIMONIDINE AFT) taken for glaucoma from an unspecified start date and ongoing; latanoprost, netarsudil mesilate (ROCKLATAN) taken for glaucoma, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaaccination. On May2021, the patient experienced rash on her stomach and bumps on the body but now went away but she is still itchy and chest with a few bumps. "She is still a little itchy. she has been scratching on her back and arms". Caller had her first dose of the Pfizer BioNTech Covid-19 last 19May2021 and a couple days after, she had a light reaction. She developed rash on her stomach and bumps on the body but now went away but she is still itchy. Caller asked if she should hold up a day or 2 for the next vaccine because she is scheduled tomorrow for her second dose and she doesn't want to have a severe reaction to the next one because she is still itchy all over. The rash and bumps began a few days later. The rash and bumps did not happen right away, it was a delayed reaction. It was not a bad rash; it was just a slight rash. Most of the rash was on the side of her stomach and chest with a few bumps. She also had a couple of bumps on her leg and thigh. The bumps on her leg and body did not all come at once. A couple of bumps would appear, and then a couple more, and then a little bit more. She took some Benadryl, and her granddaughter brought her some cream. She had been scratching on her back and arms: She had been scratching her back and arms, but there were no bumps or anything. She had been quite itching. Some days she was really itchy. This had been going on since she received the first dose of the covid vaccine. It was not a really bad itch, but she finds herself itching, and it was not normal for her. She thinks she received the first dose of the covid vaccine on 19May2021, but she might have that date wrong. She has trouble seeing and had to get a magnifying glass to read the information off of her vaccine record card. She clarifies that she did not receive the first dose of the covid vaccine on 19May 2021. She received the first dose of the covid vaccine three weeks ago from tomorrow. She received the first dose of the covid vaccine on 22May2021. She had to get something to enlarge the writing so she could read the correct date off of her vaccine record card. Therapeutic measures were taken as a result of events includes Benadryl and some cream. The treatment not received for events She is still a little itchy. She has been scratching on her back and arms and rash on her stomach and bumps on the body but now went away but she is still itchy. The outcome for event rash on her stomach and bumps on the body but now went away but she is still itchy/and chest with a few bumps was recovered on an unknown date in May2021 and another event was not recovered. Follow-up attempts are completed. No further information is expected.

Did not receive 2nd dose of vaccine, lisp tongue, couldn't pronounce any words, dizzy, itchy rash/hives on torso, very wobbly could not stand, prescribed an EpiPen.

PT DID NOT REPORT THIS REACTION UNTIL 7/9/21. SHE HAS HAD TELANGIECTASIA MACULARIS ERUPTIVA PERSTANS ON HER UPPER BACK FOR YEARS, BUT AFTER HER FIRST DOSE PT NOTED A NEW AREA FORM ON HER LOWER BACK AND UPPER BUTTOCK AREA. IT IS ITCHY. DAYS VARY WITH ITCHINESS AND IT NEVER GOES AWAY.

very very itchy.; inflamed; these isolated spots on your right and your left elbow and one side of my face and my neck, so it was isolated, it was not a rash but so itchy and red and inflamed; big red blotch that was very itchy; I was going crazy; didn't sleep; My asthma has been worse; hive like hard bumps around elbow of same arm, as well as near ear of right side.; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM6198) via an unspecified route of administration on 02Mar2021 (at the age of 77-year-old) as dose 2, single for COVID-19 immunization. Medical history included years ago penicillin allergy but have had since, bug bites allergy, allergic to mosquito bites and to insect bites, asthma, minor arthritis/spine, acid Reflux, high cholesterol. Concomitant medication(s) included atorvastatin calcium (STATIN), folic acid and multi-vitamin, vi taken for an unspecified indication in two weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) administration on right arm on 09Feb2021 (at the age of 77-year-old) as dose 1 single for Covid-19 immunization and experienced similar event with 2nd dose along with large blister. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On an unspecified date in Mar2021, the patient experienced similar events happened again after 2nd vaccine 02Mar2021 in same spots, no big blister just both elbows and neck, very very itchy as well as hive like hard bumps around elbow of same arm, as well as hive like bump near ear of right side. Followed by very itchy bumps on left arm at elbow site. Patient informed that after the 2nd shot it affected 2 elbows and the neck but no blister (same as the first but the first had the giant blister) and had gone to 2 physicians who didn't know what it was or if it may be an allergic reaction no one had identified it. Patient thought it was bug bites (allergic to mosquito bites and allergic to insect bites). It was so inflamed for a month patient was going crazy and doctor gave prednisone and Zyrtec. The 3rd person, patient spoke with thinks it's covid arm. No one can tell her what it was. Patient been to a dermatologist and internal doctor. Thinks it's the reaction to the covid vaccine. The problem with the reaction was when it's so inflamed. It feels like she got mosquito bite (like when she get a reaction) and didn't sleep the whole night. The doctor said, "I can't tell if it's a bug bite because it's so inflamed." Patient's asthma has been worse. It's horrible to have this. Thinking patient had bed bugs, it's been driving her crazy for a month. Patient informed that it's not just some itchiness, at first sight she thought she had insect bites. It happened in two locations under the right side of my neck which is like a big red blotch that was very itchy at the same time on my right arm and so the second time it happen it was not that bad, just in these isolated spots on right and left elbow and one side of face and neck, so it was isolated, it was not a rash, it was like an allergic reaction to mosquito bite but so itchy and red and inflamed. The doctor gave the patient antihistamine and now taking prednisone. Patient also asked about tests available to see if she had an allergic reaction to the pfizer vaccine. If the vaccine had histamine or would people who had allergies to bug bites have allergies to the Pfizer vaccine. The outcome of events hive like hard bumps around elbow of same arm, as well as hive like bump near ear of right side and very very itchy was recovering and rest all events was unknown. No follow-up attempts are possible. No further information is expected.

Rashes: left breast approximately 3 inches by 3 inches, left thigh approximately 2 inches by 2 inches

Itching; Tongue redness; Tongue swelling; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1283 and Expiration Date not reported) dose 1 via an unspecified route of administration on 04Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received historical vaccine of flu shot (no details provided) in September. The patient has no known allergies. The patient received the first dose of the COVID-19 vaccine a week ago and had a reaction of itching and the tip of her tongue got a little red and a bit swollen. She says she was scheduled to take the next dose of the vaccine on the 25th of this month and had some concerns. She said that the reason she called was she wanted to make sure it was ok for her to take second dose. She said she already talked to her doctor who told her to call Pfizer. The patient told that, the itching was probably for 12 hours. The patient said that, the tongue redness and being a bit swollen did not last long, she came home and had lunch and drank a lot of water. She said that the itching stayed until almost the next day and her tongue was better. She said she was concerned and went to her doctor. The patient received treatment with Benadryl one time at night, UPC: Unknown and product did not have a barcode on it and it was small tablet size and Diphenhydramine HCI 25mg said it as antihistamine on the label, with EXP Dec2021 and LOT SEF004 and took one by mouth one time. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

Large itchy blister under arm where vaccine was givenapproximately 10-12 days after 1st vaccine as well as hive likehard bumps around elbow of same arm, as well as hive likebump near ear of right side; Large itchy blister under arm where vaccine was givenapproximately 10-12 days after 1st vaccine as well as hive likehard bumps around elbow of same arm, as well as hive likebump near ear of right side; I had a big blister; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation:Solution for injection, Lot number was not reported), via an unspecified route of administration in the right arm on 09Feb2021 (at the age of 77-years-old) as first dose, single dose for COVID-19 immunization. The patient's medical history included asthma, minor arthritis, acid reflux, high cholesterol, penicilin allergy, bug bites allergy and mosquito bites allergy. Concomitant medications included Atorvastatin calcium (STATIN) 5 mg. Multi-Vitamin and Folic Acid pill (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor had been tested for COVID-19 since the vaccination. The patient experienced large itchy blister under arm where vaccine was given approximately 10-12 days after 1st vaccine as well as hive like hard bumps around elbow of same arm, as well as hive like bump near ear of right side. Followed by very itchy bumps on left arm at elbow site.The patient was given treatment for not totally yet, but itching, redness and swelling and was put on antibiotics, then prednisone, then Zyrtec. She had both doses. She stated that "after first dose I had a worse reaction (I had a big blister). It appeared 11 days after the shot; didn't happen right away. After the 2nd shot it affected 2 elbows and the neck but no blister (same as the first but the first had the giant blister). I've gone to 2 physicians who didn't know what it was or if it may be an allergic reaction no one had identified it. I thought it was bug bites (I'm allergic to mosquito bites and allergic to insect bites). It was so inflamed for a month I was going crazy. The first doctor gave me: cortisone, steroids, and an anti-inflammatory. 2nd time (after the 2nd dose) another doctor put me on prednisone and Zyrtec. The 3rd person I spoke with thinks it's covid arm. No one can tell me what it is. I saw some photos of what people had. Although I've had it in 3 different spots, under the arm, and elbow, the hand I got the shot on, under my ear (lump) and left elbow. It's on 2 arms, and part of the neck. I've been to a dermatologist and my internal doctor. Thinks it's the reaction to the covid vaccine. It on the right side, neck and right arm (not where the injection site was) giant blister on right arm between elbow and wrist at least 6 inches long and 3 inches wide. On the left side: left elbow and above the elbow. The big blister under my arm where I had my shot, neck and two elbows. The first reaction it happened 10-11 days after the first shot, after the 2nd shot: it came back, but not as a blister (soon after the 2nd shot). No body knows what it is. The problem with the reaction was when it's so inflamed. It feels like I got mosquito bite (like when I get a reaction) I didn't sleep the whole night. She (the doctor) said, I can't tell if it's a bug bite because it's so inflamed. The doctors don't know. I got no results with 2 doctors. They didn't know what to tell me, Maybe an allergist? My asthma has been worse. It's horrible to have this. Thinking I had bed bugs, it's been driving me crazy for a month. I was going to get a new bed. I have pictures; it's on my phone from the first dose. My doctor saw this and they didn't know what it was on my elbows and neck. contact caller if needed". The patient further reported that , "I have been to two doctors for some itchy things that have been happening and I did my own research and I am wondering if it could be either reaction, allergic reaction to the COVID Vaccine. Are you qualified to answer question if I give you symptoms? Well, I just want to tell you it's not just some itchiness, at first sight I thought I had insect bites. It happened in two locations under the right side of my neck which is like a big red blotch that was very itchy at the same time on my right arm where I had the shot there was a blister on the inside of my arm that was probably 6 or 7 inches long and may be 4 inches wide, and then at my elbow, it felt like I had mosquito bite that itched so much my elbow turn red and then my other arm at the elbow turn red and itchy. I went to the dermatologist, they didn't know what the heck it was, so what they did was they gave me antibiotics (captured as Unspecified medication) and it subsided for a while but it did not go away and I was using cortisone cream, steroid cream. And then after the second shot, now this reaction, the first time was not right after the vaccination it was probably close to 2 weeks after the vaccination and I didn't know what it was and nobody knew what it was. So I was thinking, I had bugs in my house. I was getting all kind of things, I called exterminator. I did not know what to do, so the second time it happen it was not that bad, but then I went to the Doctor and she said well it may be a COVID reaction but I do not understand why it's happening in these isolated spots on your right and your left elbow and one side of my face and my neck, so it was isolated, it was not a rash, it was like if you got an allergic reaction to mosquito bite but so itchy and red and inflamed, it was not funny. So nobody knew what it was, so the second doctor than gave me antihistamine and am I now taking prednisone so I am hoping that what I am doing is the right thing because nobody seems to know what it is. Let me just tell you that while I was waiting for you to answer I filled out the form but I only fill it that because I was confused at the question. I filled it out noting the reaction to the first vaccine but I did not see a spot where it say second vaccine so I just put that in section where you explain certain things, but I would rather get some information for you to make sure that I am doing the right thing what I am taking (hence no further probing was done." Outcome of the events was resolving. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Swelling; Redness; Vaccination site pain; Tiredness; Rash 4 inch circle since shot; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP0955) via an unspecified route in the right arm on 25Mar2021 at 12:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient included osteopenia, sulphur and shellfish allergy. The past drug history of the patient included gabapentin started on an unknown date for an unknown indication. The patient received lovastatin (MANUFACTURER UNKNOWN) started on an unknown date within 2 weeks prior to the COVID-19 vaccine for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route in the right arm on 04Mar2021 at 12:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Post the vaccination, the patient was not tested for COVID-19. On 26Mar2021 at 00:00, the patient experienced swelling, redness, pain at injection site (vaccination site pain), tiredness and rash of 4-inch circle since the shot. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events swelling, redness, pain at injection site (vaccination site pain), tiredness and rash of 4-inch circle since the shot was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.

7/20/21 1st Covid vaccination (pfizer) appt was at 10:30 actually received injection approx 11:15 am. around 6 hrs later, left arm/injection site began to ache. THEN, approx 8:00 pm, (approx 9 hrs after injection) I experienced slight shortness of breath (sob) plus some fatigue, headache, dizziness. Was able to go to sleep--after a while. Next morning, 7/21/21 sob more noticeable. Didn't do my regular 3-4 mile walk. By afternoon (7/21/21) great fatigue, greater headache, dizziness and shortness of breath stronger. In middle of day I went to bed and slept 4 hrs. --to nap like this...very rare except when I had Covid, late 2019/early 2020. Following evening, 7/22/21, approx. 8:00 PM, because that day had been free of sob, I took dog for walk...only reached l/8 mile, or less, because sob returned, in a stronger manner. I had to rest before able to walk back home. By 9:15 pm, same evening (7/22/21), sob worsened--although only sitting at computer. Husband found my 2019 rx of "albuterol sulfate" inhaler...( 90 mcg per puff, take 2 puffs back to back) something I've NEVER used before. This was prescribed because in 2019 because of extreme sob, now considered to be symptom of Covid. The inhalant helped. July 27, 2021, I had to use inhalent again--sob.

Elevated blood pressure; swelling in mouth/lips; Nausea; Sensitivity to sound; Severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils); This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0140), via an unspecified route of administration in the left arm on 20Jan2021 at 10:00 (at the age of 77-years-old), as a single dose for COVID-19 immunisation. Medical history included spinal stenosis, degenerative disc disease, arthritis, sciatica, high blood pressure, diabetes, high cholesterol, pollen allergy, dust allergy, ragweed allergy, carageenan allergy and fruit allergy (tomatoes). Concomitant medications included morphine sulfate (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and metoprolol succinate (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously took simvastatin on unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 22:00, the patient experienced swelling in mouth/lips, severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils), nausea, sensitivity to sound and elevated blood pressure. It was unknown if therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling in mouth/lips, severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils), nausea, sensitivity to sound and elevated blood pressure were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Pt received first dose on Monday 7/26/21 and returned to pharmacy on Thursday 7/29/21 reporting she had a sore throat the night she got her vaccine. She now has redness/red-like and warm-to-the-touch circular appearance about 3 inches below her injection site (may be cellulitis). Pt denied she did not have other symptoms like throat swelling, itching, lip swelling, etc. She will take benadryl and ibuprofen to reduce the redness/inflammation. She will also keep the area clean by washing with warm water and soap. She was advised to contact MD if she does not see it going away or symptoms persist or new symptoms occur.

"Pfizer-BioNTech COVID-19 Vaccine" 12/29 patient developed SOB, fever tmax 103 degrees F, diaphoretic, dry heaves all started approximately 16 hours after vaccination given. patient then transferred to Hospital for further treatment and observation. 12/30 seen at injection site- erythema, swelling, warmth and tenderness Discharged back to home on 1/1 with RX for cephalexin to treat cellulitis of injection site

Injection site pain,tiredness,headache,muscle pain,chills, joint pain,nausea,feeling unwell, temperature 99.6

7 am. 1/13/2021 increased poly arthritis joint pain Chills Headache Malaise . Tylenol every 6 hours 1/14/2021. headache , malaise, hyper skin sensitivity on back arms; felt like sunburn 1/15/2021 increased pain on skin especially on back headache increased malaise ; joint pain subsided, Malaise and headache has lasted for 3 full days

When I awoke this morning and was getting dressed, I noticed a soreness in the back of my left leg (on the right side of the left leg). I felt a lump, It was about 2-3 inches above the knee. It was what I would describe as a medium-sized lump. I called my doctor to leave a message about my symptoms. My doctor called a few minutes after 11 am and asked me to immediately come in so he could see the lump. He thought I might have a blood clot. This lump was not present late last night because when I put lotion on my legs after my shower, I felt no lump or soreness. I worked out this morning and by 11:00, it seemed to me the lump was not as big as it was when I was getting dressed earlier this morning.

Patient developed generalized hives starting 2 dys after her shot with worsening of her generalized hives thru the 2 dys afterward

rash which gotten bigger on the chest/rash around the side it has gotten bigger and now she is having them in other areas/rash around the left side on the arm; Very tired/Tiredness; Itching; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 07Jan2021 in the left arm at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) which she uses a nebulizer for this. There were no concomitant medications. The patient previously received first dose of BNT162B2 (lot number: EJ1685) on 18Dec2020 in the right arm for COVID-19 immunization. The patient reported that she was very tired, tiredness started on the same day as she received the second dose of the vaccine on 07Jan2021. The patient also developed a rash which gotten bigger on the chest, a rash around the side it has gotten bigger and now she was having them in other areas 3 days later (10Jan2021). The patient further explained that it also developed rash around the left side on the arm. The patient was using Cortizone cream over the counter and it relieved itching (started in Jan2021) but it didn't totally take it away. She still felt tired today. The patient had no positive tests for COVID and no antibody test before the vaccine. She had no issues with vaccine in the past. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Progress Notes (Physician Assistant) ? ? Family Medicine Cosign Needed Expand All Collapse All Date: 1/25/2021 Subjective 78 y.o. male who was seen today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the right deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience dizziness. He denied difficulty breathing and difficulty swallowing. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to hypotension and rapid progression of symptoms. Patient ate a bowl of oatmeal this morning prior to receiving his vaccine. He has only drank a small amount of diet coke today, no water. He became dizzy when standing up and some while walking. He notes the dizziness resolved on his walk to the medical evaluation bay. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness Patient denies chills, fever, facial swelling, chest tightness, shortness of breath, wheezing and headaches Previous Reactions: Denies Objective Vitals Vitals: 01/25/21 1150 BP: 133/86 Pulse: 84 SpO2: 97% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Assessment/Plan Treatment included: water Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Patients symptoms of dizziness completely resolved prior to discharge. He denied dizziness when standing up and walking to leave the medical evaluation bay. Electronically Signed 1/25/2021 12:02 PM

initially next day had redness and swelling at site >3 inches around site, still red when speaking today, but dizziness onset 1/28/2021 in the morning. Drinking plenty of fluids

pt stated that she noticed pink rash on her back in between shoulders and down both arms to the elbow.

Chills; feeling very hot; arm also swelled, about 3 inches around the site; arm also swelled, about 3 inches around the site/ it was red and itchy; arm also swelled, about 3 inches around the site/ it was red and itchy; she woke up in a horrible sweat; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1284, expiry date: 30Apr2021), via an unspecified route of administration upper arm probably only about 4inches down from shoulder blade on the left on 12Jan2021 18:00 at a single dose for COVID-19 immunization. Medical history included COVID on 01Oct2020. Concomitant medication included rivaroxaban (XARELTO) as blood thinner. The patient previously took a flu and shingles shot and experienced her redness and swelling on her arm. The patient did not have vaccinations four weeks prior, and no additional vaccines were administered on the same date. She got it because she was told by her doctor that her antibodies will not last forever and it was still necessary to get it even though she already had COVID antibodies. She contracted COVID on 01Oct2020, that was the date when she had a positive test then she was last tested in December and she still had the antibodies then. She received her first dose of the vaccine on Tuesday 12Jan2021 and 24 hours later on 13Jan2021, she experienced chills and feeling very hot, which she took Tylenol extra strength for and it disappeared the next day. Her arm also swelled, not the whole arm, she would say about 3 inches around the site, 4 inches at the most and it was still swollen, it was red and itchy. Then she woke up in a horrible sweat but by the following morning it was gone. She wouldn't say it was a horrible reaction but she wanted to be certain she can go ahead and get the second shot which she had an appointment for. She said everything has resolved completely except for the swelling, her arm was still swollen, itchy, and red. Since the swelling, redness and itchiness began she would say it was slightly better than it was. The patient received the vaccine at an independent assisted living facility, not a military facility. The adverse events did not require a visit to the emergency room or physician's office. Outcome of the events chills, feeling very hot and woke up in a horrible sweat was recovered on 14Jan2021, while the remaining events was recovering.

She has shrunk; weighs less. Maybe 154 pounds. She was 170; she got first dose of Pfizer COVID vaccine on Monday 04Jan2021/She will get the second dose on 01Feb2021; she got first dose of Pfizer COVID vaccine on Monday 04Jan2021/She will get the second dose on 01Feb2021; had congestion; Coughing; choking; body was more than hot it was burning/body turned very hot; could not sleep/two sleepless nights; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization, ciprofloxacin (CIPRO), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication and pirfenidone (ESBRIET), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication. Medical history included pulmonary fibrosis (diagnosed between 2007-2010), Lymphoma type B, blood pressure (abnormal), cholesterol (abnormal), vertigo, biopsy, tightening of legs and feet, drip (nasal) and pain. Concomitant medication included gabapentin for tightening of her legs and feet, diphenhydramine hydrochloride (BENADRYL) for drip (nasal) and meloxicam for pain. It was reported that the patient took the vaccine and had two sleepless nights on 05Jan2021, her body turned very hot but she have some conditions. Sleepless nights: they have been really rough nights. Scary. Coughing and choking. She thinks the vaccine kicked in and started beating the hell out of it. The patient clarified that she is having sleepless nights because of the coughing, choking, and burning and she feels that it is related to the vaccine kicking in. She slept last night, 14Jan2021. The cough is starting again today (as reported). She hopes it calms down. When she said her body was hot, like burning she was describing her sleepless nights. She is afraid. She is keeping in contact with her doctor. She figured she better call because more people are on this medication. The patient also experienced congestion on 06Jan2021. It was reported that the patient has shrunk and weighed less. Maybe 154 pounds. She was 170. The action taken for ciprofloxacin and pirfenidone was unknown. The outcome of the event congestion was not recovered, while unknown for the rest of the events.

This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EL0142), via an unspecified route of administration on 12Jan2021 at a single dose on the right arm because she doesn't want to get Covid. Medical history includes the patient being sick before she got the shot, she had the flu since an unspecified date in Dec2020 during Christmas time. She didn't feel well before. She thought it was Covid and her friend was also sick that time and did have Covid. She stated that her own symptoms were like the flu, no fever, just regular flu symptoms. There were no concomitant medications. The patient reported that got her first vaccine this past Tuesday, 12Jan2021. She has been fine, but her arm is quite red since an unspecified date in Jan2021, and was tender since 13Jan2021 but was not hurting. When she took off the band aid the next day to take a shower, everything was okay. On Thursday, 14Jan2021 when she woke up she noticed redness and it was tender. SHe added that her arm is quite red and tender to the touch. She was asking if she should put hear or ice on it or just leave it alone. She wanted to know if this was normal. She stated that she has had a dull headache since an unspecified date after receiving the vaccine. Her arm was also swollen on an unspecified date after receiving the vaccine and sore. The patient wants to know if there are any recommendations for treatment. The outcome of the event vaccination site erythema was not recovered, the outcome of the event vaccination site pain was recovering the outcome of the other events was unknown.

Around 3PM about 7 hours later of shot The left side injection / problem left side of Face from cheek bone to jaw line redness , puffiness plus skin irritation chaffing . her left side of lip she complained of slight numbness it was suggested that if irritation take Tylenol which we did two over 4 hours before bed around 1AM took one Advil she was restless to go to sleep fearful finally around 3AM tired enough to fall asleep About 11AM called my niece Nurse Hospital she said take Benadryl but speak to DOCTOR First he said same thing did for about 4 days Swelling and Redness went down numbness lower lip still slight their now about 10 days later acceptable feeling still wondering why??

Debilitating pain and swelling at vaccination site with a ring around the shot. Pain then transferred to other arm with body aches and low grade fever. Pain at shot site duration was 10 days with no relieving factors.

Patient in clinic for 2nd dose of covid vaccine. Within 8 minutes of receiving her injection, pt developed a rash on both arms; pt states both arms are itch and her throat felt as if it were closing. Rapid response called and patient was given Epinephrine per anaphylaxis protocol by LPN at 4:26pm. BP-146/98 p88 R17 Rapid response team arrived at 427pm. 429pm: Assessment: patient stable but felt no improvement in her throat. Pt was transported to ED for assessment.

Around the site of injection, it was like a red circle like a size of an inch; I felt like a little warm to me; Around the site of injection, it was like a red circle like a size of an inch; I felt like a little warm to me; She didn't know what but it is itchy, it hurts or a combination of both; She didn't know what but it is itchy, it hurts or a combination of both; My arm hurts/her arm felt like a little sore; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) via an unspecified route of administration, on 06Jan2021 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medications included metoprolol and lisinopril, both for high blood pressure. Patient stated that she got the Pfizer vaccine on 06Jan2021. The regular reaction to it like her arm hurts and that was it, it lasted like for three days and it went away. Not yesterday, but the day before (15Jan2021), her arm felt like a little sore. Yesterday (16Jan2021), when she was in the showering, she noticed that the around the site of injection, it was like a red circle like a size of an inch that was (sentence incomplete). She felt like a little warm to her. She didn't know what but it was itchy, it hurt or a combination of both, it didn't bother her unless she touched it or rubbed against it but it was there. So, she just wanted to know whether that was a reaction to the injection or what that was, is that common or is that not common. Patient said she still felt it. As treatment, patient took a paracetamol (TYLENOL). She took one paracetamol this morning (17Jan2021) and one yesterday (16Jan2021). Outcome of arm hurts/arm felt like a little sore was recovered, outcome of other events was not recovered.

she had a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest; Chest tightness; like she was going to faint or go to sleep; like she was going to faint or go to sleep; she barely had a little pain at the COVID-19 Vaccine injection site that went away quickly; This is a spontaneous report from a contactable consumer, the patient. This 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249), dose 1 , single dose via an unspecified route of administration in the left upper arm on 08Jan2021 at 09:15 AM (at the age of 78 years-old) for COVID-19 vaccination. Relevant medical history included ongoing high blood pressure in Dec2020. Concomitant medications included valsartan (DIOVAN) 160mg tablet, once a day from 10Dec2020 and ongoing for high blood pressure and clobazem (CALM) from Jan2021, lot: 1115941, expiration: Mar2022. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 08Jan2021 at 09:15 AM, the patient barely had a little pain at the COVID-19 vaccine injection site that went away quickly. On 18Jan2021, the patient had chest tightness and a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest. She said it was like she was going to faint or go to sleep. She said the wave went down to her chest area and stayed for a big portion of the day. She said she had a heaviness in her chest, clarified as a chest tightness. She said she has no heart issues. The patient still had some tightness in her chest and it may be just from worry. She said she was normally calm, so she was not sure about what was causing her current chest tightness. The patient did not think what she experienced on 18Jan2021 was serious enough to contact her primary care doctor. There were no relevant laboratory tests done. The patient did not require a visit to the emergency room or physician's office. The clinical outcome of event, barely had a little pain at the COVID-19 vaccine injection site was recovered on an unknown date in Jan2021. The clinical outcome of event, wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head was recovered on 18Jan2021 after treatment was given. The clinical outcome of chest tightness was recovering after treatment was given. The clinical outcome of like she was going to faint or go to sleep was unknown.

[Pfizer covid -19 vaccine] treatment under Emergency Use Authorization(EUA): Patient in clinic for 2nd dose of covid vaccine. Within 8 minutes of receiving her injection, pt developed a rash on both arms; pt states both arms are itch and her throat felt as if it were closing. Rapid response called and patient was given Epinephrine per anaphylaxis protocol by LPN at 4:26pm. BP-146/98 p88 R17 Rapid response team arrived at 427pm. 429pm: Assessment: patient stable but felt no improvement in her throat. Pt was transported to ED for assessment.

Patient received Shingles Vaccine on 01/6/2021 and COVID-19 Vaccine on 01/26/2021. Pt began with rash on 01/27/2021, rash is located on the center of her back. She began with pain on 01/26/2021 in the morning, reports her pain is located beneath her armpit radiating both toward the front and back

broke out in shingles on opposite side; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid vaccine, lot EL9261), via an unspecified route of administration on 15Jan2021 11:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included blood cholesterol increased and high blood pressure. She takes other stuff for cholesterol and high blood pressure. The patient experienced broke out in shingles on opposite side on 15Jan2021. She was treating it with a steroid shot and taking acyclovir, 5 a day for 7 days and also methyl prednisone and it is a packet and takes 6 a day. Her doctor also gave her a compound to rub on it. The outcome of event was not recovered.

severe itchiness from waist up - behind ears, head, back, neck, shoulders; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL9261) on 21Jan2021 at 12:45 at single dose in Left arm for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), asthma, osteopenia/porosus and sulfa allergy. Patient was not pregnant. Concomitant medication included fluticasone propionate (FLONASE); nitrofurantoin (MACRODANTIN); alendronate sodium; budesonide/ formoterol fumarate (SYMBICORT); dupilumab (DUPIXENT) from12Jan2021. On 22Jan2021 the patient experienced severe itchiness from waist up - behind ears, head, back, neck, shoulders. Case is reported as non serious. No treatment administered for the adverse event. Outcome of the event was not recovered.

Approximately 10 minutes after receiving the COVID- 19 vaccine resident displayed seizure activity, staring straight ahead and strong allover muscle jerking of both the up and lower extremities, color became gray, activity lasted approximately 3 minutes, resident then became relaxed, color returned to normal, BP-140/80, 97.8, 60, 16, sleeping the remainder of the shift,. Resident continued to decline until resident CTB on 1/19/21

About 7-10 minutes after receiving the shot, patient started to feel extremely shaky and warm. Her face turned red and hands were shaking. Patient felt her heart skipping with irregular heart beats. The nurse measured the patient's blood pressure and it was 183/95 with a pulse of 104. The patient was observed for an hour.

view 2/5/2021 09:23 e Progress Note Note Text: Patient passed away in the facility this morning. view 2/5/2021 08:39 Orders - Administration Note Note Text: Resident passed. view 2/5/2021 08:33 Nurses Note Note Text: Body released to funeral home at this time. Personal effects sent with resident include: 1 pair of glasses, 1 yellow wedding band, 1silver spoon ring, 1 ring with black and clear stones. Resident has own teeth view 2/5/2021 08:32 Nurses Note Note Text: cause of death per CRNP failure to thrive. view 2/5/2021 07:44 Orders - Administration Note Note Text: Take and document temp & PO2 every 4 hours for MONITORING Resident passed. view 2/5/2021 06:49 Nurses Note Note Text: Son returned call and was updated of resident's passing this am view 2/5/2021 06:33 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger PRN Administration was: Unknown Resident expired @ 0604 [linked] view 2/5/2021 06:06 Nurses Note Note Text: Res found without pulse or respirations. Pronounced at 0604. Updated. N/o's for RN to pronounce, release body to funeral home, dispose of medications per facility policy. Daughter updated. Funeral Home called to release body. view 2/5/2021 05:26 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger Pulse ox 60% on O2 @ 5L/min via mask. Resps 44 per minute. view 2/5/2021 01:57 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger PRN Administration was: Effective Follow-up Pain Scale was: 2 [linked] view 2/5/2021 00:52 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger Residents resps are 40 per minute, pulse ox 76% on O2 @ 5L/min via mask. Resps are labored, shallow and rapid. view 2/5/2021 00:48 Nurses Note Note Text: Nonresponsive to verbal and tactile stimulation. Appears comfortable. view 2/4/2021 22:01 Nurses Note Note Text: Resident resting comfortably, breathing becoming increasingly shallow, wearing O2 via mask at 5L via mask, no dyspnea noted, feet are mottled, oral and peri care provided Q2H. No s/s of pain or discomfort. view 2/4/2021 21:40 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger PRN Administration was: Effective [linked] view 2/4/2021 19:32 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger medicated for air hunger, RR 28 to 32/ min view 2/4/2021 19:22 Nurses Note Note Text: Daughter updated on N/O to increase Morphine Sulfate 20mg/mL 0.25mL to Q2H prn from Q6H prn. view 2/4/2021 18:06 Nurses Note Note Text: POA Daughter and daughter aware of residents current condition. view 2/4/2021 11:58 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB PRN Administration was: Effective Follow-up Pain Scale was: 2 [linked] view 2/4/2021 11:13 Nurses Note Note Text: Pt. noted to be lethargic at this time. Does respond to verbal and tactile stimuli by opening her eyes but non verbal currently. Skin warm and dry. No mottling or apnea observed at this time. O2 sat 88% with O2 at 2 LPM via n/c. On increased to 3 LPM via mask as pt. noted to be mouth breathing. Respirations 28. F/U O2 sat 93%. HOB elevated. Pt. medicated with morphine by LPN. Daughter updated on pt.'s condition. Does not want pt. sent out to hospital and would like comfort measures to continue. Daughter also in agreement with delay in d/c d/t pt.'s condition.CRNP updated on pt.'s condition, delay in d/c and daughter's wishes. No n/o's at this time. view 2/4/2021 10:56 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB Resident showing s/s of discomfort. SOB at this time and high respirations. Repositioned, changed for incontinence care and mouth care provided. view 2/4/2021 10:34 Progress Note Note Text: Spoke with RN regarding change in condition. Updated Sr Living regarding change. Recommendation to cancel d/c/transfer for today, see how resident does through the weekend and re-evaluate on Monday. Daughter updated on cancellation of d/c today. view 2/4/2021 10:04 Nurses Note Note Text: Daughter aware that resident's O2 sat was 88% on room air on 3-11 shift and that oxygen was applied via nasal cannula. view 2/4/2021 10:03 Nurses Note Note Text: N/O: Discharge 2/4/21 with scripts to Sr. Living. Daughter aware. view 2/4/2021 09:53 Nurses Note Note Text: Pt. to be d/c'd to another facility this am as per MD order. Pt. alert and responsive. Skin assessment done as per facility policy. No pressure areas noted at this time. No s/sx of pain or discomfort observed at this time. V.S. 97.0 67 20 O2 sat 95% with O2 at 2 LPM via n/c. view 2/4/2021 07:45 Nurses Note Note Text: Resident seen by Dr. for discharge. Orders pending at this time. view 2/4/2021 07:36 Nurses Note Note Text: CRNP and Dr. updated on O2 sat 88% on RA with f/u of 93% with O2 on at 2 LPM as well as rest of VS, 3-11 shift 2/3/21. No n/o's at this time. view 2/3/2021 21:17 Nurses Note Note Text: Resident Sp02 88% on RA. Pulse 124. Respirations 40. PRN morphine given and O2 applied via NC at 2L/min. After recheck pulse ox up to 93%, pulse 100, and respirations 22. Resident appears comfortable at this time. view 2/3/2021 20:05 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB PRN Administration was: Effective [linked] view 2/3/2021 19:48 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB PRN given for SOB after elevation of HOB not effective. view 2/3/2021 11:51 Nurses Note Note Text: CRNP updated rapid COVID test done for d/c tomorrow was negative. No n/o's at this time. view 2/3/2021 11:44 Nurses Note Note Text: Daughter notified of rapid covid swab being negative. view 2/3/2021 09:50 Orders - Administration Note Note Text: Obtain Rapid Covid test on 2/3/2021 for discharge. Please give copy of results to Social Worker every day shift for covid testing for 1 Day Completed and negative. view 2/3/2021 08:45 Skilled Nursing Note Reason for skilled service: Therapy describe skilled service: Nursing, therapy assessment: V.S. 97.8 79 18 138/84 Orientation: Oriented to self only. Oxygen: O2 sat 94% on RA Edema: Trace edema noted BLE. Pedal pulses present. Pain: Denies pain or discomfort at this time. Nursing note: Pt. alert and responsive. Skin warm and dry. Lung sounds diminished. No respiratory distress observed at this time. Abdomen soft. BS+ in all 4 quads. Continent/Incontinent of B&B. 1 assist with ambulation, transfers. 1 assist with ADL's. Working with therapy on gait training, therapeutic exercise, therapeutic activities & neuromuscular reeducation. view 2/2/2021 14:37 Progress Note Note Text: Per health professional at Sr Living, prepared to accept patient to their Memory Care Unit 2/4. Transportation arranged for 11 AM per family request. Daughter (POA) updated on d/c time on 2/4/21. Facility requesting rapid COVID test completed prior to d/c and results sent to them. All other information sent for continuity of care.

About 10 minutes after receiving the covid vaccine, I developed a red flush on my face which was bright, hot and uncomfortable. The flush appeared nowhere else on my body so I concluded that the vaccine must have interacted with the tretinoin cream I use nightly. That is the only area of my skin on which i apply the cream. When I got home, I applied soothing skin cream but no relief. I then tried aloe, which grows in the area, and the flush/burning abated somewhat. The next day, my face was still flushed but less red. the skin surface was scaly. I am continuing to treat at home. No MDs involved.

welts/ she has had welts before in the past/welts on right and left arm, Left shoulder, Right buttocks fold, and both lowers legs; welts/she has had welts before in the past/welts on right and left arm, Left shoulder, Right buttocks fold, and both lowers legs; Itching; This is a spontaneous report from a contactable consumer. a 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: 30Apr2021, NDC number: 5926710001) on 14Jan2021 at right arm at single dose for covid-19 immunization. Medical history included Welts. Concomitant medication was not reported. Caller is a Pharmacy Tech and a patient had the first dose of the Covid 19 vaccine and had itching (15Jan2021) and whelps (17Jan2021). She would like to know if these are normal side effects and if the patient can get the 2nd dose. Pharmacy Technician is calling about the Covid Vaccine. It was administered to a patient and the patient experienced an AE. Pharmacy Technician clarifies that she is calling on behalf of the patient. She started itching a little on Friday 15Jan2021, then Sunday she started getting welts that were the size of pencil erasers to a dime. She would take Benadryl and when she took it, she was fine for 24 hours. Then welts every day, in different areas, she had the welts on right and left arm, Left shoulder, Right buttocks fold, and both lowers legs. The added that she has had welts before in the past but she was not sure what caused them in the past. Reporter does not know if the itching and welts are still ongoing or when it stopped. The Patient did state that Itching went away with Benadryl however reporter does not know when or if that is still the case. Not sure when it stopped. Patient didn't provide end dates or if the adverse events ended. The Patient did not list any allergies. When queried if the patient had any positive covid or antibody test prior to the vaccine, caller states that all of the patients that they vaccinated, they ask them if they had any positive test within 90 days, all stated no, if they state, they do not give the vaccine and make then wait. Caller asks if there is any information about if these side effects are normal, as well as if the patient is still able to receive the second dose. the last outcome of the events was unknown. It was reported as non-serious.

Off and On High Fever (102.7) with sever chills, nausea, fatigue lasting six days. Chills stop, low grade fever continue for three more days, rash appears on my neck, back and front of my body. Doctor insist I get a Covid 19 test. It came back negative. This was my first pfizer vaccine.

swelling and significant bruise at injection site; swelling and significant bruise at injection site; This is a spontaneous report from two contactable nurses. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular into the left arm on 21Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were none. The patient developed swelling and a pretty significant bruise where the injection was given in her left arm. The caller noticed the bruise and swelling on 25Jan2021 but states it could be older. The events were reported as medically significant. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of vaccination site swelling and bruise cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.

Bilateral upper arms reddened, swollen and pain resident also presented with a temperature. No treatment rendered for the localized reaction however antipyretic medication given and resolution of temperature achieved. Primary care physician ordered allergy to the COVID-19 vaccine.

Exhaustion onset about 8:00 PM 1/26/21 lasting over 36 hours before starting to feel better. I literally slept all of the next day only getting up occasionally and most of the day after that. I started to become more normal feeling the late afternoon of 1/28/21. I also felt very stiff and uncomfortable. Sore neck and joint pain and a slight headache. I had a sore area across my arm (felt like a bruise although there was no discoloration) about 1 inch inch below the injection sight which was on my upper left arm. That persisted for several days. I slept and took 1 800 mg Ibuprofen (on 1/27/2021). Am feeling better but still not feeling 100 %. That may be due to increased allergies due to time of year of etc a

she had quite a rash, it was red, right where the injection was made; it was warm; her arm was hurting a bit; slight headache; This is a spontaneous report from a contactable consumer (patient) and contactable physician. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263), via an unspecified route of administration at arm left on 22Jan2021 at single dose for COVID-19 immunization. The patient medical history included COVID-19 (with symptoms: terrible headache, cough, shortness of breath for good 6 weeks and fatigue) from Nov2020 to an unknown date. The patient experienced slight headache on 23Jan2021, her arm was hurting a bit on 25Jan2021. On 26Jan2021, her arm was still sore, it was warm, she had quite a rash, it was red, right where the injection was made, the rest was more pink. The patient outcome of headache was recovered on 24Jan2021, the outcome of the other events was not recovered.

Pt c/o hives on face. Benadryl 25mg was given po. EMS evaluated patient and pt declined to go to ER.

The right arm started itching on2/13/2021. It was a little redish, itched was why I noticed it. Am going to see my Health car doctor Monday 2/15/2021. I have filled this out as best I know how. I have had no pain, no syptoms of any thing else. Just the itch swelling .

Developed red, swollen area around injection site, approximately 3?X3?. Site is warm to touch and per patient is ?itchy?. Denies any pain, muscle aches, fever or headache.

blister developed on left foot 4 hours after 1st vaccine 01/25/2021. blister formed on left great toe 4 hours after 2nd vaccine 02/15/2021

My Mom had an an allergic reaction four hours after receiving her first dose of the Pfizer Covid 19 vaccine. Her face swelled up and became red....worse on the right side than the left...her eyes were swollen as well. It lasted this way for four days....it is a little better now, but her face is still a little swollen (seven days after shot). She had a headache on and off and felt tired (which we understand is not an allergic reaction, but rather an immune response). Her family physician suggested taking antihistamines before her second shot. Needless to say, we are apprehensive about what the outcome from the second shot will be like for her.

Had CoVid vaccine #1 1/22/21 - felt fine. 2/5/21, eyes became swollen and red - called her eye Dr, who met her after hours at his clinic and diagnosed with shingles. She does not remember ever having chicken pox but states she might have forgotten. She called MC to inform us she could not return 2/11/21 for her second vaccination d/t the shingles. We also had a second person vaccinated the same day that also called with shingles so decision was made to enter this variance report.

Exp. Date 6/30/2021. Unable to lift my left arm higher than my shoulder, swelling of upper left arm, tiredness.

(Registered Nurse) Pt reports a rash developed the next day after receiving her first Pfizer vaccine, occurring across her midsection of abdomen. It lasted for 2 weeks. No other problems with the vaccination. Reports that her physician recommended that she continue with second dose as scheduled.

1. Immediately had very unpleasant metallic taste in mouth. 2. Five to ten minutes after injection had very severe headache. After returning to car, took 2 extra strength (500 mg) rapid release Tylenol. Headache lasted 5/6 hours. 3. Soreness around injection site for 2 1/2 days.

On 2/19/2021, 78yr old female with history of asthma, diverticulitis, GERD, hiatal hernia, HTN, and hyperlipidemia was administered second dose of COVID-19 Pfizer vaccine 0.3mL in left deltoid (LOT # EN6201). Patient has several documented allergies including dextromethorphan (anaphylaxis), guaifenesin (anaphylaxis), olmesartan (itching), erythromycin (unknown), hydrocodone (unknown), atorvastatin/pravastatin/rosuvastatin (muscle pain), codeine (throat swelling), shrimp (hives, itching). Patient received first dose of COVID-19 Pfizer vaccine on 1/27/21 without any documented issues. Patient initially tolerated injection without incident and was sent for post-injection 15min observation. During 15min observation period, patient became dizzy, diaphoretic, nauseated, and unable to walk with steady gait, hypertensive and endorsed hives. EMS called and patient sent to ED. During initial presentation to ED, BP 180/80, HR 85, and 97% on RA. Patient given Benadryl 25mg PO and ondansetron 4mg IVP at 2055. 1L LR bolus given at 2059. BP lowered during ED observation (BP 160/80 on 2/20 at 0442). Acetaminophen 650mg PO given at 0442 prior to discharge. Patient discharged home in stable condition ~ 0500 on 2/20 with plan for patient to follow up with outpatient provider. EpiPen was not prescribed at discharge. No update to EPIC allergies noted at this time. Of note, reporter notes unable to check POC BG at clinic (glucometer unavailable). Patient has no history of diabetes, but noted that has similar "episodes" with low BG. EMS checked BG (POC = 144).

1/12/21 er HPI: HPI 78 y.o. female who presents with pain swelling and redness left wrist and hand associated with fever according to EMS, but temperature in the ER is 98.4° F. patient was said to have fallen on 1/7/2021. *incidental finding bacterial pne* 1/12/21 admission History: The patient is a 78 y.o. female with a past medical history notable for Dementia, atrial fibrillation, CHF, diabetes, reflux. The patient presents for evaluation of Worsening issues of decline and trouble with breathing. Patient was evaluated the ER and found to have a urinary tract infection in addition to pneumonia. Due to patient's dementia history is difficult to take outside of history of which was taken for patient's nursing staff at skilled care facility. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed

Developed urticaria within 2 hours of vaccine. Rash began on chest and spread to her neck and on her face.

I have osteoarthritis, with Heberden's nodes on all of my fingers. 3 days ago the two nodes on the most affected finger (and the first that showed the arthritis) turned bright red. Now the whole joint is red and a few of the other nodes have turned red. Except for binding the first finger with the hope it would help (it didn't), I'm not treating them, since of course one can't do anything about osteoarthritis except ease the pain.

A couple of days after receiving 2nd shot my arm was a little sore and then began to itch. Then I got a round red spot on my arm at the injection site. It continued to spread and get bigger

Swelling, which is hard like an egg, at the injection site; Redness at the injection site; Very lethargic; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry date unknown), via an unspecified route of administration at the age of 78 years, on 22Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus, ongoing urinary tract infection, hyperparathyroidism from 21Jan2021 and ongoing, ongoing osteopenia, ongoing meningioma, seizure from an unknown date and unknown if ongoing. The patient received the first dose on 02Jan2021. On 23Jan2021, the patient experienced swelling, which was hard like an egg, at the injection site and redness at the injection site. The patient was also very lethargic on an unspecified date. No treatment was received for the events. The outcome of the event lethargic was unknown while other events were not recovered. Information on the Lot/Batch number has been requested.

itching, swelling and rash in the genital and anal area, itchy also on her legs, was sore in the gluteus area Has not seen the doctor yet (2/26/2021)

medical history of arthritis treated with cortisone; medical history of arthritis treated with cortisone; Rash on her face/rash on the cheek; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included ongoing arthritis in her knee (for 7-8 years) and blood pressure high but so far so good. Concomitant medication included cortisone for arthritis in her knee. The patient previously had cortisone shot for arthritis and experienced rash on her face. On 14Jan2021, patient got the first vaccine dose and had rash on her face/rash on the cheek. Her next one is due 04Feb2021. The outcome of the events was unknown. Information on Lot/Batch number has been requested.

Swollen at the injection site; Lump on Left Arm; Left arm was painful /it was painful to the touch/it more like a numb dull pain; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3246; Expiration Date 28Jan2021), via an unspecified route of administration in the left arm on 26Jan2021 12:15 (at the age of 78-years) as a single dose for COVID-19 immunization. There was a no medical history. The patient's concomitant medications were not reported. The patient received the vaccine on 26Jan2021 and in the evening her left arm was painful, she could not sleep on the arm. On 27Jan2021, before she took a bath, she still had the band aid on and it was still hurting a little, the area was swollen at the injection site, it was painful to the touch, she could feel a lump on the left arm, she still could not sleep on the arm. On 28Jan2021 the swelling went down and was still painful, but it was not a sharp pain, it more like a numb dull pain, she was calling to ask if that is normal. The patient treated herself with paracetamol (TYLENOL) prophylactically 2 hours prior to vaccination and on an unspecified date rubbed some alcohol on the injection site. The swelling was reported as just a little. The lump was completely gone but she still felt the dull pain. The clinical outcome of the event left arm was painful and swollen at the injection site was recovering; and lump on the left arm was recovered on 27Jan2021.

she has been shrinking; the COVID-19 Vaccine injection site was a little itchy, red, and hot when she first noticed the adverse reaction on 15Jan2021; the COVID-19 Vaccine injection site was a little itchy, red, and hot when she first noticed the adverse reaction on 15Jan2021; the COVID-19 Vaccine injection site was a little itchy, red, and hot when she first noticed the adverse reaction on 15Jan2021; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number 61R84), via an unspecified route of administration on 14Jan2021 at 12:00 (at the age of 78-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included macular degeneration from an unknown date (for which patient received macular degeneration shot in her eye on 11Jan2021. The shot was the medication "Elyce"), high blood pressure and thyroid condition (both for which patient takes unspecified medications) and bad back for which patient received epidural (unspecified medication) on 13Jan2021. Concomitant medications Elyce (as reported) for macular degeneration, epidural (unspecified medication) for back pain, and unspecified mediations for high blood pressure and thyroid condition. The patient did not receive any other vaccines within four weeks prior to the vaccination and had no additional vaccines administered on the same date of the vaccination. On 15Jan2021 the patient experienced vaccine injection site was a little itchy, red, and hot when she first noticed the adverse reaction on the second day, 15Jan2021. She said the COVID-19 Vaccine injection site stayed warm and itchy for 3 days. She said she noticed the red spot was still at the COVID-19 Vaccine injection site this morning, and asked does she need to worry about the red spot. She clarified the redness at the vaccine injection site is a half circle, and the vaccine injection site is not burning or itching. The patient did not receive any treatments for the vaccine injection site was a little itchy, red, and hot> The patient stated she "has been shrinking" from an unknown date. The patient also reported she has a history of a bad back and she had an epidural the day before getting her first COVID-19 Vaccine dose. She clarified she had the epidural on 13Jan2021. The patient stated she does not have the epidural medication name, dose, NDC, Lot and Expiration Date, since the epidural was given at the orthopedist's office. She said she received a notice from her orthopedist, who administered the epidural on 13Jan2021, stating that Pfizer recommended not to have an epidural when having the COVID-19 Vaccine because the epidural may not be as effective. She said she is not going to go back for her second epidural with the orthopedist, but plans to have her second COVID-19 Vaccine dose. She clarified that the letter from her orthopedist stated she can schedule her next epidural a week after receiving the COVID-19 Vaccine. The patient stated she was more concerned about getting her second dose of the COVID-19 Vaccine than getting a second epidural with her orthopedist. The patient reported she still had a half dollar sized red mark at the COVID-19 Vaccine injection site. The clinical outcomes of the vaccine injection site was a little itchy, red, and hot were recovering. The outcome of the event she has been shrinking was unknown.

I started really scratching and it's really is pink red pumps on my stomach; it spread my whole stomach, then over the breast and under the arm, around my back; rash; I started really scratching and it's really is pink red pumps on my stomach; it spread my whole stomach, then over the breast and under the arm, around my back; rash; I started really scratching and it's really is pink red pumps on my stomach; it spread my whole stomach, then over the breast and under the arm, around my back; rash; Blood sugar was very high; Blood pressure was very high; I had shingles on it; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 29Jan2021 (at 78-year-old) at single dose for COVID-19 immunization (Because she was of that age and she wanted to travel again). Medical history included ongoing Diabetic. There were no concomitant medications. Reason for no lot number of COVID 19 Vaccine, consumer stated, "It says Pfizer, EL9267, no 62, I am not sure now. Maybe I think it says 2, it's a 2." She woke up at 1 in the morning and started really scratching (31Jan2021) and it's really is pink red pumps (31Jan2021) on her stomach. It started to spread in the whole stomach, then over the breast and under the arm, around her back. She had the reactions. It was a total rash (31Jan2021) and red. She took her blood sugar, she was diabetic, her blood sugar was very high (Jan2021), then she took her blood pressure, her blood pressure was very high (Jan2021). She was all ready to go to the hospital because when you have a rash that's not good. But now 3 hours later her rash disappeared and she felt much better again. When confirmed if the consumer wanted to report the same or have some questions, consumer stated, that she have question, why did she get the rash after she had the COVID vaccine, she had her shot on Friday, Pfizer shot vaccine on Friday. She stated that she felt better, she only have a little bit in her back itching. But everything else it was so red, she meant she had shingles (Jan2021) on it. It's the hospital who gave her the shot. Due date for the next shot was on 19Feb2021. It was stated that she is Diabetic, she don't take any medication, she did it on her own and she is border lined. On lab work, consumer stated that every half a year she had a blood test. Regarding treatment, the consumer stated that she didn't take anything, she was wondering if she was allowed to take anti-histamine. The outcome of the event Itching and Redness was recovering, rash was recovered, while other events was unknown. Information on the lot/batch number has been requested.

some soreness in left arm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9261), via an unspecified route of administration on 25Jan2021 at 13:45 at a single dose on the left arm for COVID-19 immunization. Medical history included high blood pressure and a-fib (atrial fibrillation) both from an unknown date and unknown if ongoing. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medication included lisinopril (LISINOPRIL), amlodipine (AMLODIPINE), atenolol (ATENOLOL), apixaban (ELIQUIS). Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient experienced some soreness in left arm next day, 26Jan2021. The patient did not receive any treatment for the event. The outcome of the event was recovered. The event was reported as non-serious.

Very mild soreness at the injection site; Very Mild fatigue; This is a spontaneous report from a non-contactable consumer (female patient). A 78-year-old female non pregnant patient received second dose of bnt162b2 (Formulation: Solution for injection, Lot number: em9809) via unspecified route of administration on left arm, on an unknown date at single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient previously took historical vaccine, first dose of bnt162b2 for COVID-19 immunization. It was reported that the patient experienced very mild soreness at the injection site and very mild fatigue on 08Feb2021. The patient administered most recent COVID-19 vaccine at doctor's office/urgent care, had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medication (unspecified) within 2 weeks of vaccination (as reported). The patient didn't receive treatment for the adverse events. The patient had not diagnosed with COVID-19 prior to vaccination and since the vaccination. It was reported that patient had no allergies to medications, food, or other products. The seriousness of the events was reported as non-serious by the reporter. The outcome of the events was reported as recovered on an unknown date in Feb2021. No follow-up attempts are possible. No further information is expected.

rash upper arms; Itching; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration on the left arm, at the age of 78 years, on 20Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included diabetes mellitus from 1980 to an unknown date and rheumatoid arthritis from 1980 to an unknown date. The patient's concomitant medications included an unspecified flu shot in Nov2020. The patient experienced some rash in the upper arm and itching on 20Jan2021 which has gotten better (she added that she did not take anything medical for this, just a night cream). She added that she was allergic to epinephrine which she mentioned during her first shot. She was asking if it was okay to proceed with the second dose. The patient said that she got the first dose injected on January 20th to her left arm, and that evening she had the rash. She says she didn't really treat the rash, she just used cream for the itching. She says the rash was that she broke out on the upper part of both of her arms. She says that the itching did get better. Therapeutic measures were taken as a result of itching (pruritus). The outcome of the events was unknown.

PT received 2nd dose of Pfizer at 1730. PT presented with hives down her arms in the observation room and EMS was alerted at 1735. EMS took vitals, and PT refused Benadryl. PT presented with hypertension (NIBP 227/116) and hospital contacted by EMS. PT agreed to be transported to the Hospital. Medic arrived at 1805 and transported PT to ER.

Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recipient experience an allergic reaction. They developed headache and throat closing. They were treated by EMS on site with diphenhydramine and methylprednisolone. They were transported to emergency department at Regional Medical Center. They reported itching, swelling, and tingling around the mouth. During reexamination, the patient?s symptoms did not recur and they were discharged to home. Registered 03/03/2021 3:00 PM, Discharged 03/03/2021 6:13 PM.

Patient experienced bad back pain, stomach spasms on night of vaccine. Starting on 2/28 hives and welts covered entire body. Very itchy. When she called to report on 3/4, reported they come and go and are not as severe as at onset.

Admitted to the hospital in observation status on 3/8/21 with chief complaint of "I don't feel well, I feel dizzy and I had a rash." Patient treated in urgent care on 2/24/21 for possible UTI and again in urgent care on 3/2/21 for cat bite and given ceftriaxone IM as well as Augmentin. Patient complains of feeling a little dizzy and not quite well, rash was fleeting but she has not been eating or drinking well since vaccination and has been having headaches since that time. She is afebrile and has no respiratory symptoms but positive covid-19 test (and antibodies). Patient did complain of nausea and dehydration. Discharged on 3/9/21.

Initial slightly sore arm at injection site. Two days later noted slightly erythematous, mildly itchy confluent macular rash near (but separate from) injection site. Rash persisted has persisted and is still present, though appears to be fading. Photo taken on day 5 of rash and is available if desired. No other side effects from vaccine #2. Slight sore arm from vaccine #1 only.

Patient called stating four days after shot, started to have pain in arm and was black and blue. Had been taking pain relievers and ice pack around the clock. Referred patient to PCP for follow - up and to continue until seen.

fire red palms, soles of feet, ears; fire red palms, soles of feet, ears; fire red palms, soles of feet, ears; Pinpoint rash on arms, legs, torso; Palms extremely itchy; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration in the right arm on 02Feb2021 at a single dose for COVID-19 immunization. Medical history included iodine allergy and opioid pain meds allergy. Concomitant medication included chlorphenamine maleate (ALLERGY OTC) and an unspecified statin. Patient not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown) on 12Jan2021 in the right arm. On 07Feb2021 12:00, 5 days after the second COVID shot, patient experienced fire red palms, soles of feet, and ears; pinpoint rash on arms legs, torso; and palms extremely itchy. Events lasted 4 hours, faded in same order of appearance. Treatment received for the adverse events was Benadryl. This case was reported as non-serious. COVID-test post vaccination (nasal swab) on 08Feb2021 with result unknown. Outcome of the events was recovered on 07Feb2021 16:00. Information on the lot/batch number has been requested.

2/15/2021 covered with unbelievable rash from my neck to my ankles!! Lasted for more than 12 days and was extremely itchy.

left arm aching from the site of the injection; aching from back of her arm to the back part of her elbow, then it comes to the far outer part of her forearm down to the wrist and ring finger and pinky finger.; numbness down left arm/partially numb, she has feeling because it's aching; itchy torso from armpits to hips/itchy back and stomach; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6201), intramuscular, administered in left arm on 23Feb2021, 14:00 as single dose for COVID-19 immunisation. Medical history included neuropathy in feet, cholesterol (abnormal), 2 vertebra in her back that are starting to fuse, shrinking as she's getting older, allergic to NSAIDS, she clarifies Advil, Tylenol and the medications reverses on her and gives her a headache, and she gets itchy; was in the hospital for surgery, for lady stuff and needs glasses. She doesn't have a heart problem she doesn't have any other medical issues. She's not diabetic the neuropathy was idiopathic. Concomitant medications included atorvastatin for cholesterol (abnormal), acetylsalicylic acid (BABY ASPIRIN), and duloxetine hydrochloride (CYMBALTA). The patient previously took morphine and was allergic, and hallucinating as she was told by the nurse, she said there were monkeys on the ceiling and her husband was trying to kill her and gets itchy with morphine. This is the same reaction she had when found out she had the reaction to NSAIDs, for example, she could take Advil or Tylenol for one night but it she took it two nights, that was when she woke up itching all over. She reports no rash, just itch. It just lasted that one night and it was gone. She could take some Advil and get that itchy feeling. On 01Mar2021, the patient experienced left arm aching from the site of the injection back down under the back of her arm to the back part of her elbow, then it comes to the far outer part of her forearm down to the wrist and ring finger and pinky finger; numbness down left arm/it was also partially numb, she has feeling because it's aching and she was describing it as an ache, not sharp just an ache. She can feel it, but its not all there. She knows all this stuff was new to all of us. She's following up and doesn't keep her up at night it's just not normal; and on 24Feb2021, her torso, the night after injection, from her armpits to her hips was itchy. She woke up and she went to the bathroom scratching her back and stomach. Her Covid 19 vaccine card was handwritten she sees 23Feb2021 and that's the date she got the shot. She's been isolating since Feb2020. She was only going out for necessity. She took a risk and had family at her home for Christmas. She hasn't been to church in almost a year, so she was taking this very seriously. Before they even started telling you to wear a mask she was listening to the news in December and January. She states, alright she's isolating, it's the safest thing she can do she's not ready to leave this world yet even knowing she's past her golden years. Her doctor put her on Atorvastatin it because of her age, she had blood drawn but she wasn't given any counts on an unspecified date. Her first thought was she had a chest problem but it's not a heart attack, the ache doesn't go any farther than what she told. It's not stopping her from being productive, from doing things. The events did not require a visit to the emergency room, physician office and was not hospitalized. The patient had no prior vaccinations within 4 weeks and no events following prior vaccinations. Outcome of event itchy torso from armpits to hips/itchy back and stomach was unknown; and outcome of the rest of events was not recovered.

Eyes swollen; lids puffy and red, red circles around each eye; lids puffy and red, red circles around each eye; yellow jaundice look below each eye in a little pouch filled with fluid; itchy eyes; skin on eye lids peeled off; yellow jaundice look below each eye in a little pouch filled with fluid (this jaundice look with pouch disappeared within 5 -6 days from receiving 1st shot).; This is a spontaneous report from a contactable female other healthcare professional reported for herself that 78-year-old female patient received first dose bnt162b2 (Solution for injection, pfizer (Batch/Lot Number: EL9265)) via an unspecified route of administration, administered in Arm Left on 28Jan2021, 16:45 as single dose for covid-19 immunisation. Medical history included myocardial infarction from 2014 to an unknown date In good health - Heart Attack 2014 , drug hypersensitivity from an unknown date and unknown if ongoing known_allergies: Sulfa drugs. The patient historical vaccine bnt162b2 (Solution for injection) on 28Jan2021 Start Date/Time: [Pfizer Lot EN6198] 19Feb2021 09:45 AM, left arm for covid-19 immunisation. Facility most recent COVID-19 vaccine was administeredin Doctor's office/urgent care. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. On 01Feb2021 07:00 AM, Eyes swollen, lids puffy and red, red circles around each eye, itchy eyes, skin on eye lids peeled off, yellow jaundice look below each eye in a little pouch filled with fluid (this jaundice look with pouch disappeared within 5 -6 days from receiving 1st shot). Other eye condition remains. The event Yellow ocular coloring was recovered in 2021 and other events not recovered.

Lightheadedness; tired; aches in her hands; corner of her eye and around it was itching really bad; started hurting and felt strained; started itching in her body; Headache; muscle aches; Nausea; Chills; This is spontaneous report from a 78-Year-old Female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9269), via an unspecified route of administration on 02Feb2021 at single dose for covid-19 immunization on arm left. The patient relevant medical history and concurrent conditions included cataracts from 2005 with ongoing, macular degeneration from 2012 with ongoing, arthritis from an unknown date and ongoing and fingers and both hands that had knots since 2010. The patient stated that she had nausea, chills, headache, and muscle aches on 02Feb2021, and on 03Feb2021, she had lightheadedness, tired, and aches in her hands where she has arthritis and all at once that the corner of her eye and around it was itching really bad and she touched it to relieve the itch and they started hurting and felt strained. The patient got Systane over the counter eye drops that she had and held hot compresses to it. She reported that it lasted for a few hours and she had cataracts and a little macular. The patient started itching in her body at 7:30 and took Benadryl and went to bed and it went away. She was concerned with second vaccine as she got through the nausea and everything else, but her eyes scared her. The patient received treatment medication for nausea and took Tylenol for Arthritis and muscle aches. The patient had an x-ray 3 years ago for her back and was diagnosed for unknown results. The outcome of the events nausea, aches in her hands, corner of her eye and around it was itching really bad, started hurting and felt strained and started itching in her body was resolved on 03feb2020, whereas the events chills, lightheadedness, tired, headache and muscle aches were resolved on 04Feb2021.

I had the second Covid (Pfizer) vaccine on February 22. The next day I had chills, fever, aches, nausea and was very weak. After about 30 hours I felt okay again. However, a week and a half later, I noticed red bumps on the back of my neck. The next day, my neck and scalp had red, itchy blotches. Through the next five days, these spread down my body to my ankles until I was covered with the red, very itchy blotches. I did go to Urgent Care on the third day and I was given a 5-day prescription of Prednisone. It did not do much until the third day and then it relieved the itching somewhat for about 6 hours, but then it would start again. After the five days of Prednisone, I took Benedryl for three days until the itch and redness disappeared. I checked the facility web site on types of rashes and my rash fits the description (and the photo) of a drug-related rash, but I have not changed or added any drugs for several years other than the Covid vaccine (I did some research online and found two other people who have had the same problems I have had after the second Covid vaccine. Both of them had the typical reaction of chills, fever, aches and dizziness for about a day after the second shot and then 1-2 weeks later, broke out in a rash. Both reported having the rash start at the neck or head and then spreading down the body throughout one to two weeks before disappearing. There were photos on the facility site of drug-related rashes and they were exactly like what I had. Since the rash was almost certainly covid vaccine related, I am making this report, which my doctor recommended. I had no other changes in diet, medications, environment, etc. ? only the Pfizer vaccine was new to my body.

Rash: Very itchy, dry, red, pimple-like rash over head, face and back. Pain onset 03/20/2021. Onset about a day after injection; continues on 03/22/2021. No other symptoms.

Pt received 1st dose of Pfizer on 3/17/21 at 2pm in right arm. Then, on 3/18/2021, at 7pm, patient noticed rash under armpit of left arm while in the bath. Patient called PCP who instructed her to take benadryl. Rash progressed, so patient went to ER. ER doctor recommended patient not take any further medication (patient had already taken benadryl prior to going to ER). 3/19/2021 patient decided to continue benadryl 25 mg three times that day. By 3/20/2021, rash had progressed further down her legs, so patient returned to the ER. Rash was only on the arms and legs, and was NOT on torso or chest. No itching, no SOB, no lip/tongue swelling, no fever. In ER, patient was instructed to continue benadryl and was given medrol dose pack, which she was encouraged NOT to take. Patient discharged from ER and returned home. On 3/21/21, new lesions were still appearing, and patient was told to visit PCP on 3/22/2021. On 3/22/2021, patient noticed her left hand was swelling, so medrol dose pack was started. Patient had dramatic improvement in rash and swelling with 24 hours of steroids. On 3/25/2021 patient returned to PCP, rash was resolving well.

The injection was given high up on my arm and was very painful. About an hour after receiving the shot my arm felt weak and my hand and fingers felt numb. I could not raise my arm. This lasted into the next day, when my shoulder began to hurt. The feeling returned to my hand but I started getting drawing pains in my arm, and increasing pain in my arm when raising it.

Cholestasis and Pneumonitis. Improved over 2 months after course of steroids. Noted to be jaundiced about 7 days after vaccine. Liver biopsy demonstrated likely drug injury superimposed on steatohepatitis. Then had worsening dyspnea requiring admission on 2/21/21 for 2 days.

2/2/2021 red scaly skin rash dorsum right hand. Next day pinpoint hemorrhagic 2-4 mm sized lesions on palmar surface of fingertips and sides of fingers, 21 in all. Diagnosed as clots by cardiologist and dermatologist on 2/25.Gradual resolution and healing by 3/14/2021.

Skin eruptions all over my body. They are itchy and irritating. They are little red spots, some of them puss filled. I took prednisone pills with no result so was give cortisone shot. Still no relief. This has been going on since a week following the second vaccine shot. There have been no changes that I can recall in foods I eat or cleaning products I use or other things that might affect the skin. The only new thing seems to be the vaccine.

pt stated that about an hour after she got the vax she had severe headache, extremely tired and pain in right leg muscle. On 2/20/21 all symptoms were gone except the pain the the right leg between her hip and knee on the outside of the leg. On 2/26/2021 she went to the ER. They did Covid Test, EKG, Chest X-ray and blood work. All test were negative. She was released to go home. On 3/4/2021 she woke up and her right leg had turned black and blue. She call 911 and taken to the ER where they did blood test, EKG, Chest Xray, CT, Spine Xray and US to see if she had any blood clots. She did not have any blood clots and all test were negative. Pt was released to FU w/ her PCP on 3/12/21. He took more blood work. Pt was told to drink water take more vitamin D. Pt still has some pain.

I lost consciousness; hitting my head; bruising body; when I had my blood pressure taken it was over 200 landing me in ER overnight to try to get my BP down; suffering with Arrhythmia; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Feb2021 (lot number: EN6201) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), administered in the right arm on 01Feb2021 12:00 AM for COVID-19 immunisation and experienced achy body, tiredness, fever and chills. After the second vaccine early in the next morning (23Feb2021) around 3 am, the patient lost consciousness when retuning from the bathroom hitting her head and bruising body. She lay on the floor for approximately 15-20 minutes. She was ordered by her primary care physician to have a brain scan but when she had her blood pressure taken it was over 200 landing her in emergency room (ER) overnight to try to get her BP down. She was now on beta blockers and was still suffering with arrhythmia awaiting an appointment with her new cardiologist. She was hospitalized for 2 days due to the events. She had no COVID prior vaccination and has not tested COVID post vaccination. She has no other vaccine in four weeks. Therapeutic measures were taken as a result of the events. The outcome of the events were not recovered.

cannot take good deep breaths because of the soreness in her ribs; soreness in her ribs; She had no urge to eat/Has no desire to eat or drink; lost 10 lbs; feel ill; General feeling of the flu; had a slight sore arm; nausea; severe pain, her hip and knee were killing her; was having major problems, a delayed immune response; Rash covering her entire body; acute pain and with deep breaths; low grade fever; cough/Cough was a dry, tight, non-productive cough; Weakness; Chronically dehydrated; the COVID Vaccine wasn't working; the COVID Vaccine wasn't working; This is a spontaneous report from a contactable nurse. This nurse (patient) reported that a 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN6204) at the age of 78-years, via an unspecified route of administration on 04Mar2021 at single dose; first single dose of BNT162B2 (lot: EM9810) on 11Feb2021; both for COVID-19 immunisation. Medical history included osteoarthritis (having aches and pains) had for 20 years; large sliding hiatal hernia was diagnosed from an EGD six months before, didn't want surgery to fix it; heartburn (last five years); fatty liver, was not from drinking alcohol; generalized anxiety; was tuberculosis positive only because she was exposed years ago. Concomitant medications included pantoprazole started four to five years before at 40 mg twice a day for heartburn; escitalopram (tablet) been on for 15 years or longer at 10 mg 1 DF every day for generalized anxiety; clonazepam 0.5 mg nightly at bedtime for anxiety (been taking for last ten years or more, stops her from worrying about her kids and stuff like that). The patient experienced on 07Mar2021, low grade fever, weakness, chronically dehydrated and cough; on 15Mar2021, rash, acute pain and with deep breaths; on an unspecified date, no desire to eat or drink. Seriousness criteria of these events were reported as disabling. Patient reported that was having major problems, a delayed immune response. Told everybody if this keeps up she was not going to make it. It was wearing her down and she was not going to survive. Occurred after second COVID vaccine. She is active, goes to pool, and does different things. Had vaccine on Thursday and was ok until Sunday. Started Sunday with low grade fever. Kept being low grade and never got to 101, 102, or 103. She didn't take ibuprofen. Usually takes ibuprofen once a day for routine aches and pains. Having weakness. Had no desire to eat or drink. She waited a couple days, but then called her doctor. Doctor's office wouldn't give her an appointment. Stated this wasn't the routine and has been going on for 10 days. This was too much. Two days later, caller's daughter-in-law took her to a place like an ER. A bunch of tests were done. She asked for an IV because she was chronically dehydrated. Weakness was getting to her. After seeing the doctor in the mini surgical ER, she didn't feel any better. She felt the same. Same nausea, weakness, low grade fever, the whole thing. Decided to see her regular doctor. Stated it wasn't her chest. Wanted to be told what was going on. Her regular doctor didn't order any labs. She was given a steroid shot. Thought she was in deep doo-doo. Stated this was not a good sign and she was not going to make it. She woke up yesterday with a rash covering her entire body. She had no clue she had the rash. Never saw the rash. Rash didn't itch, but she still had it. After steroid shot from doctor, she felt a little bit stronger and thought maybe she was going to make it, but then started getting severe pain. Patient was used to having aches and pains that went along with old age and her osteoarthritis. This was severe pain as if she fell and hurt her ribs. It hurts to take deep breaths. Her hip and knee were killing her. It was acute pain, not normal pain. This morning stated she couldn't take it and was going to take ibuprofen, which was not the best for her. She didn't want to eat, but tried to have food in her stomach to take the ibuprofen. She cannot take good deep breaths because of the soreness in her ribs. Thought something in her body was having a delayed immune response and her gut told her it was not good. For low grade fever, did not take ibuprofen, 07Mar2021 was when she started feeling yucky, she wanted to see how she felt and her temperature never really got up, stuck it out, normal temperature for her was 97 or lower, her temperature once in a while would range from 98 to 100.3 or 100.8, she cannot take paracetamol (TYLENOL). For weakness, noticed right away, felt a little better after steroid, had not been out of her door except to the ER. For chronically dehydrated, clarified she had no desire to eat, usually drinks coffee and tea in the morning, but now had no desire, was making herself drink, felt something wasn't right beginning on 07Mar2021, everything went south and got worse, clarified it really wasn't nausea, but no desire to eat or drink, doctor today gave her ondansetron (4mg) which didn't help and made it worse, eating and drinking didn't make her sick, just didn't want it. She had labs done in the ER and was told her labs weren't really that off for her to be that dehydrated. Asked for an IV because she was not drinking what she normally drinks, didn't feel any better after the IV. Rash covering her whole body, but didn't itch. Acute pain and with deep breaths began evening of 15Mar2021, seemed the same today, she just took an ibuprofen a little while ago and was feeling better. Patient also mentioned that realized her body was trying to get monoclonal antibodies and resistance to build up her immunity so that if she ever got infected with COVID virus she could fight it, it was just not working, it was not doing its thing, she was having a delayed immune response, was very worried about that, going on 8-9 days and it was weakening her by the day, didn't think she could take this too much longer. Clarified the COVID Vaccine wasn't working and her body couldn't get its act together. Patient had a slight sore arm after the second dose, never reacted at the injection sight, it was strictly internal, which kind of scares her, something was not right, was having the rash, pain, and severe weakness. Was not expecting any kind of problem. Didn't think too much about the second COVID Vaccine. Stated people were like "oh that second shot." If she didn't get better soon she is not going to do well. Cough was a dry, tight, non-productive cough, lungs were checked yesterday and were clear, felt like all of a sudden she has an urge to cough and nothing comes up. For steroid shot, didn't know if it was dexamethasone (DECADRON) or not, made her feel a little stronger for the day, but then brought on severe aches and pains in her joints and ribs, did not have this until the steroid shot. Patient said that didn't take ibuprofen the first couple days because she didn't want to mess up the immune response starting in her body, asked doctor about immune globulin for her delayed immune response, but doctor shook his head, knew that people with autoimmune are ordered IGE or IGG to test the immune system, asked doctor about this, but he shook his head. Stated she didn't think a CBC with different was performed at the ER, confirmed she was only in the ER after the second dose and was not admitted to the hospital. As of 17Mar2021, she stated then two to three days after that she woke up with rash over her entire body that showed up overnight, that alarmed her even more of course, no itch or nothing, no clue it was there until she washed off and could see it, she had never had a rash before, her arm never got red, but she had a low grade fever, stated now didn't know if good or bad, cough, not productive, some urge to cough, no appetite, not eating or drinking, and increasing weakness, today she couldn't say anything was different about her rash maybe slightly faded but she didn't feel any better, she did get a steroid shot when she went to doctor yesterday and that made her feel less weak. As of 18Mar2021, patient stated that had no reactions for the 1st 2 days following her 2nd dose however she started to feel ill, low grade fever that never went above 100. General feeling of the flu; aches and pain, which she had before but more than usual. She had no urge to eat. Tried to see her doctor when it had been going on for 5 days but they were not concerned. By that Friday, she went to the hospital. They found nothing wrong in her lab tests but she asked them for I.V fluids since she hadn't eaten or drank anything. On Monday, she went back to her initial doctor because she had a rash all over her body, it did not itch and her injection site had no redness. She was given a steroid shot, today she might be feeling a bit better. She lost 10 lbs. She had to stay inside for the past 10 days, except for doctor visits, although she was usually an active person. She would like to know how long the side effects would last. Outcome of the events low grade fever/ wasn't working, weakness, rash and acute pain and with deep breaths, cannot take good deep breaths and soreness in her ribs was not recovered/not resolved while of remain was unknown. Relatedness per primary source reporter via global introspection of BNT162B2 to events low grade fever, weakness, chronically dehydrated, no desire to eat or drink, acute pain and with deep breaths and cough were related.; Sender's Comments: Based on a temporal association and the known drug safety profile, the reported events are considered possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

1 giant hive at vaccination site- itchy for about 1 week; 1 giant hive at vaccination site- itchy for about 1 week; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 14Feb2021 13:15 (Lot Number: EN6201) as 0.3 mL, single for COVID-19 immunisation. Medical history Thyroid Nodules, Mild macular degeneration, postmenopausal syndrome, HBP, total hysterectomy w/ oophorectomy, gall bladder removal, appendectomy, penicillin allergies, adhesives allergies, HOH allergies, allergies: contrast dye. Concomitant medications included valsartan (DIOVAN); estrogens conjugated (PREMARIN); levothyroxine sodium (SYNTHROID); pravastatin; colecalciferol (VIT D3); famotidine (FAMO). The patient previously took nitrofurantoin (MACRODANTIN) and experienced allergies, claritine (CLARITIN) and experienced allergies. The patient experienced 21Feb2021- 1 giant hive at vaccination site - itchy for about 1 week, started 2 days after injection (16Feb2021) - very mild - arm was not sore at all. Treatment received for the events which included self medicated with benadryl & Aleve. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovering.

Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 1 week after receiving my second vaccination, my hair starting falling out and is still falling out at an alarming rate

Headache at base of skull 1st night (Sun), next morning all muscles ached, significant pain in many joints, tremendous fatigue, inability to concentrate, dizziness. Swelling, pain, redness left arm shoulder to elbow.Took Tylenol, spent most of the day in bed. Not hungry. By Tues I felt much better, but fatigued (still needed 2 naps), little appetite. Wed continued recovery, but weak, arm continued red, swollen, painful to the touch. Today, Sunday and a week after injection, I feel normal.

Rash/The rash got worse from day to day as it spread throughout her body/The rash went from there to her face and went throughout body.; She also had swelling and itchiness with the rash.; She also had swelling and itchiness with the rash.; Low grade temperature 99.3 degrees; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Feb2021 15:00 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included hodgkin's disease from 2007, cardiac disorder was the patient taking concomitant products. Concomitant medication(s) included losartan (LOSARTAN) taken for cardiac disorder from an unspecified start date and ongoing; amlodipine (AMLODIPINE) taken for cardiac disorder from an unspecified start date and ongoing; warfarin (WARFARIN) taken for anticoagulant therapy from an unspecified start date and ongoing; Toprolol taken for cardiac disorder from an unspecified start date and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have history of all previous immunizations with the Pfizer vaccine considered as suspect. The patient did not administered any other vaccine on same date of the suspect. Caller on the line calling about the COVID 19 Vaccine. She was informed to call and report any reactions to the vaccine. She received the vaccine on 02Feb2021 and three days later she developed a rash. The rash started on her feet and spread throughout her whole body. She also had swelling and itchiness with the rash. Caller went to her primary care doctor on Monday 08Feb2021 and it was suggested to her to go see an allergist because the primary care doctor could not determine what this reaction could be other than the vaccine. The rash got worse from day to day as it spread throughout her body. It started on her feet went to her ankles. She then had swelling with it; it was itchy, very itchy. The rash went from there to her face and went throughout body. She noticed it in the afternoon on 05Feb2021. She had socks on and her socks were getting tighter due to swelling. She took her socks off and then noticed the rash. She also added, she had a low grade temperature. It was 99.3 degrees. Initially stated the low grade temperature started on Thursday 04Feb2021, but then stated it could have started Friday, she is not sure. It was one of those days. She thought she had a low grade temperature for two days. She did not even take the temperature the second day because she felt so crappy and did not feel like taking it. The caller was given a name of an allergist and she would go see the allergist on 18Feb2021. The patient did not visited to emergency room. The patient visited to physician's office. Outcome of the events rash, she also had swelling and itchiness with the rash were not recovered and unknown for other event.

rash; headache; No appetite; chills; sweat; fever; body aches; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received second dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: EM9809) via unspecified route of administration on 09Feb2021 at single dose for covid-19 immunization. Relevant medical history and concomitant medications were not provided. It was reported that caller and his wife received the second dose of the Pfizer-BioNtech Covid-19 vaccine on Tuesday, he experienced a little of body aches that disappeared; however, his wife experienced a severe reaction: ongoing chills from 10feb2021, ongoing sweating from 10feb2021, ongoing headache from 10feb2021, from 10feb2021 to 11feb2021 experienced fever, ongoing body aches from 10feb2021 and today she broke out in rash on the front of her body from 11Feb2021 and ongoing no appetite from 10feb2021. They would like to know if there are any recommendations on what to do. Calling about the Covid 19 Vaccine. States that he and his wife had their 2nd doses of the vaccine on Tuesday afternoon. He had very little side effects; just body aches. But his wife woke up the first night after getting the shot with chills, fever, sweats, headache, and body aches. Today she is feeling a little better; her temperature this morning was 99.2, and she had a really bad headache. When she got in the shower, she noticed that she had a rash on her body; it doesn't itch. States that she has a little appetite today, which is good because she didn't eat at all yesterday. Asks, what does he need to do, if anything at all? States that he went on the Pfizer website and the side effects were listed there, one of the bad ones was a rash, so he would like to speak with Medical Information. Caller does not have the full contact information to provide for the prescribing physician. States that she got the shot about 2:15-2:30pm and the aide effects started about 12 hours later. States that she goes from being hot to cold to lukewarm, so the chills come and go. Her fever is gone, her temperature is now 97.5. The headache was really bad this morning, but she only feels a little pressure now. The rash is on her back and legs, but it has gotten better in the last hour. States that her appetite has improved; she just ate some breakfast. The lot number on the card is difficult to read due to the handwriting. Caller states that by comparing her card to his card, they think the Lot number is either EU9809 or EM9809. Caller later states that after looking at if for longer he really thinks it's EM9809. The outcome of the events for "Chills", and "Sweating" was "Not Recovered", for "Fever" was "Recovered", and for "Headache", "Body aches", "Rash", "No appetite" was "Recovering". Follow-up attempts are completed. No further information is expected.

severe rash and hives over entire body; severe rash and hives over entire body; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 at 09:30 AM as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were reported as eliquis 5mg, venlafaxine 150mg, atorvastatin 10mg. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that on 22Jan2021 at 11:00 PM patient experienced severe rash and hives over entire body.Patient received the treatment with zyrtec, prednisone, benadryl, hydrocortisone. Outcome of all the events were recovering.

arm swelled; hot at injection site; This is a spontaneous report received from a contactable consumer reported that: A 78-years-old female patient received bnt162b2 (BNT162B2; solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 03Feb2021 17:30 (Batch/Lot Number: EL1283) as single dose and on 13Jan21 receveid BNT162b2 (Lot#EL0142)as single dose for covid-19 immunisation. The patient medical history was unknown. The patient's concomitant medications were unknown. On an unspecified date, the patient experienced arm swelled, hot at injection site. After 2nd day, occurred after 4th day. number of previous doses was 2nd shot. Outcome of the events were unknown.

3/3/2021 - Left Upper Arm Swollen Hard Muscle, no Pain, 3/8/2021 - Periodic Tingling up and down beneath skin of Left Arm,in addition to Swollen Muscle Applied Cold Compresses and Tylenol Caplets with relief of tingling sensations 3/16/2021 - Covid Pfizer Vaccine #2 (Right Arm) - only temporary small bruise spot at injection site 3/25/2021 - Urgent Care for Swollen Upper Left Arm and unchanged Tingling discomfort (Advised to continue Cold Compresses and follow up with Primary Care Provider) 3/29/2021 - Left Arm increasing pain up to Shoulder and Neck - weakened arm strength, use challenge, and sleep discomfort 4/12/2021 Earliest Upcoming Appointment with my Primary Care Provider

Awakened morning of March 20, 2021, with flaming red burning skin on left chest from scapula to edge of atrial, huge welts of 2? and 1? in diameter, appearance of blisters, itchy rash, intensely itching. Today is April 7, and the area is faintly pink with itchy bumps near clavicle of an area 4?x4?.

Pt admitted on 4/5/2021 c/o roughly 4 weeks of just general dyspepsia and feeling like she had acid reflux. She reports that then progressed to some nausea and then vomiting and then some generalized right upper quadrant midepigastric abdominal pain. She also noticed that her skin was becoming yellow. She reports no changes in any of her medications recently she had her second COVID-19 vaccination on 2/14 and blood work on 2/ 8 consisting of liver enzymes/CMP was normal. she arrived severely jaundiced with severe transaminitis, hyperbilirubinemia and acute renal failure. ERCP revealed no gross obstruction and free flowing bile and sphincterotomy was done with no improvement in her blood work. she remains hospitalized and is being transferred for HLOC due to worsening condition REVIEW OF SYSTEMS:

3/27 got 1st pfizer vaccine in her right arm had injection site pain for a week and finally resolved the next day woke up with severe right arm pain, hurts to lift it sleeps on side and this also hurts it no weakness but hurts to raise it up no prior injuries no trauma pain in lateral shoulder, minimal neck pain, no pain distal to elbow no numbness or tingling on warfarin so has been afraid to take anything for this pain 5/10 at rest and much worse with movement

Patient received her first Pfizer COVID-19 vaccine and began feeling throat tightness, SOB, chest tightness and itching about 15 minutes after vaccine. Patient was going to be observed for 30 minute due to history of anaphylaxis. Patient was given 0.3 mg epinephrine in left thigh and 50 mg benadryl IM in right deltoid at 17:06. VS before medications 174/73 HR 73 and after medications was 187/64 HR 78. Nitro patch was removed by Dr. prior to medication administration.

About 5 days after injection, I had a bout of nausea and diarrhea and noticed severe itching. The stomach issues resolved after a couple of days, but the severe itching continued and is especially bad wherever my clothing comes in contact with my skin. Over the next several weeks, I tried hydrocortisone cream, Benadryl gel, Benadryl tablets, Calamine lotion, corn starch, menthol itch cream, but nothing has helped for very long. I don't have much of a rash...just a bit of raised redness when the itching is particularly bad. I have been miserable with it. I visited my neurologist for Botox injections and asked her about it and she said she thinks I'm having a histamine reaction to the Covid vaccine. The severity of the itching is getting slightly better, but it's now been almost 6 weeks of unrelenting itching. I'm not taking Benadryl 3 times a day.

2/24/2021 thru 3/1/2021 - Left Arm pain and tenderness at injection site - less pain each day. Treatment: Tylenol Caplets (temporary relief) 3/3/2021 - Left Upper Arm Tricep Muscle noticeably Swollen and Hard when touched- No pain. Treatment: Cold compresses (little relief) 3/8/2021 - Left Arm Periodic Tingling up and down under skin, in addition to Swollen Tricep Muscle Treatment: Cold compresses & Tylenol Caplets (temporary relief) 3/25/2021 - Urgent Care for Swollen Upper Arm & Tingling discomfort Advice: Continue Cold Compresses, Monitor and follow up with Primary Care Provider 3/29/2021 - Continued Left Arm Tingling and increasing Pain at Left Upper Back & Shoulder, weakening Left Arm Strength, usage challenge, sleep discomfort, Tricep Muscle less swoIlen, Treatment: Cold Compresses and Tylenol (temporary relief) 4/12/2021 - (Pending) earliest available appointment with my Primary Care Provider

After 5 minutes of receiving vaccine, patient became nauseous. Once home, she complained of dizziness. Around 4am, patient was awakened with strong heart palpitations. She noticed ankle and foot swelling after about a day. She also noticed a rash on the vaccine arm, neck and under chin. She experienced severe nausea and vomiting over the next 3 days and could not eat food. She did not seek medical attention and chose to stay in bed to recover. As of today, the patient says she is almost recovered from these events.

site sore to touch/Left arm injection site hot, red and starting to itch and hard.; site sore to touch/Left arm injection site hot, red and starting to itch and hard; site sore to touch/Left arm injection site hot, red and starting to itch and hard; This is a spontaneous report from a contactable consumer (Patient). A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an intramuscular route of administration, administered in Arm Left on 12Feb2021 11:00 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history cholesterol and When she was 3 years old, she had whooping cough. Concomitant medication(s) included Livalo 4 mg once a day for cholesterol, Clopidogrel 75 mg daily for blood thinner for stents in heart both taking for 2 year. On 14Feb2021 the patient experienced vaccination site sore to touch/left arm injection site hot, red and starting to itch and hard. She measured it 3 inches by 1.5 inches wide. They have her scheduled to receive second dose on 05Mar2021. She would like to know if she should receive it on the same arm, or was that too soon to get it on the same arm. She was on a walker and don't know if using walker had agitated her arm. She needed to use walker for 4 1/2 years prior. They pinched it up and she did not feel it when she gave her the injection. Because of her age and she has always gotten a flu shot, everybody was asking her if she wanted to get this vaccine. She was on a blood thinner, and she did tell them she was when she got the vaccine. She had stents put in her heart prior to the vaccine. She had Historical Vaccine Flu shot for immunization in Oct2020, but none after that except the Pfizer COVID vaccine. The patient underwent lab tests and procedures which included investigation: she measured it 3 inches by 1.5 inches wide on 14Feb2021. The outcome of event was not recovered.

Extreme joint and muscle pain, extreme fatigue I took tyleno, tramadol and advil at the appropriate time periods, Very sore injection site; became very, very red swollen and went down my arm almost to my elbow, around to underside of my arm. The pain and fatigue lasted 1 week and I stayed in be most of the time as I felt terrible. The arm lasted approx 3 weeks, I used benadryl and over the counter cortisone cream.

swollen lymph node in my left arm pit that was red and tender to the touch. Swelling and tenderness disappeared in approximately 25 days. Dr viewed it on April 13th & confirmed it was a swollen lymph node

About 5 or 4 days ago my scalp towards the top of the head hurt while going to sleep on my back. I assume that I probably scratched my head while shampooing my hair. Then next day my right eye started to bother me. I thought I had bumped my eye while trying to clean the discharge I have in the mornings with q-tips. But finally it got worse until it hurt me. So I went to the ophtlamologist today who according to his diagnosis I had shingles. I just got an antiviral medication for the next seven days and drops to help clean my eyelids. This is so bothersome, sometimes while trying to read I see blurry.

I had a mild reaction to the vaccines both times. I am now reporting that I have developed Shingles for the first time, My symptoms began on 4/16/21. I was diagnoses as having shingles on 4/20/21. I researched shingles and Covid and found that Israel has reported several post vaccine cases of shingles. Thus I am reporting my own condition to determine if there is a causal relationship.

Psoriasis appeared on my scalp in several areas.A dermatologist was consulted and diagnosed this..; This is a spontaneous report from a contactable Consumer. A 78 -year-old non pregnant female consumer received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered in Left arm on 13Jan2021 10:00 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. On 18Jan2021, the patient had experienced Psoriasis appeared on scalp in several areas. A dermatologist was consulted and diagnosed this. Betamethasone dipropionate lotion was received in response to the adverse events. On 04 Feb2021, patient had other vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the event was resolving.

left arm feels "heavy", warm to touch and continued redness at injection site. No pain or tenderness voiced.Patient has antihistamine cream, advised to apply anti histamine cream to affected area.

Location of vaccine shot still pink and slightly painful almost a month after shot. Breathing difficulty 3 days after shot was resolved using Benadryl.

hurting on right side of face, in and around R ear; hurting on right side of face, in and around R ear; severe headache; nausea; vomiting; severe dizziness; All over body rash; This is a spontaneous report from a contactable consumer or other non hcp. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jan2021 08:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included high BP, hx of blood clots/CAD, covid-19 from 10Dec2020 to an unknown date. Concomitant medications included warfarin sodium (COUMADIN); and atorvastatin calcium (STATIN [ATORVASTATIN CALCIUM]); both taken for unspecified indications, start and stop dates were not reported. On 26Jan2021, 12:00 AM, 3 days later started hurting on right side of face, in and around R ear, severe headache/nausea/vomiting & severe dizziness. All over body rash occurred. 10 days later and lasted 3 weeks. The patient received treatment for the events: antibiotic/anti nausea/MRI/CT. The patient was hospitalized for five days for the events. The outcome of the events was not recovered. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on an unspecified date, magnetic resonance imaging: unknown results on an unspecified date. The patient has not been COVID tested post vaccination. Information on the lot/batch number has been requested.

Sore at injection sight (mild) next day. Nothing noticeable until 24 Apr 21 Pounding headache, fatigue, sleepy long periods , mild sore throat, blood pressure lower than usual . Temperature with in normal limits . I have been resting a lot , waiting for conditions to improve, however, as of this writing nothing has changed. Thus I decided to file this report. my I have not seen my healthcare provider yet but will make contact tomorrow

Pain; a lump down from where the injection site was/ lump in the arm, 4 inches down from the shoulder where she got the shot; her shoulder aches; shoulder aches and the feeling goes into the arm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 78-years, at single dose in left arm on 03Mar2021 10:00 (Lot number was not reported) for covid-19 immunisation. Medical history included type 2 diabetes that diagnosed about 3 years ago, this year makes 4 years, and she took medications for it. And she was a little overweight, supposed to drop some but gained some back that because of diabetes. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) also at age of 78-years, at single dose in left arm on 02Feb2021 13:00 for covid-19 immunisation and she had no problem with that one. Another Historical Vaccine included flu shots, it just lasted a day or two, maybe that's it, never had problems before. The patient's concomitant medications were not reported. The patient reported side effects from the Pfizer COVID vaccine. Her arm was still bothering her. There was a lump down from where the injection site was and that she kept rubbing it but it won't go away and that she still had pain. She was told she should go to the doctor, but she thought she would call to see what was best to do. She had not a fever, just the lump on the arm, 4 inches down from the shoulder where she got the shot. The patient stated that both Pfizer COVID vaccines were in her left arm, she should have gotten it in the other arm. The patient stated she heard about blood clots and thought she'd better check it out. The patient stated that she had the lump and her shoulder aches; not the shoulder the upper arm. The lump was on the inside and she kept rubbing it but it didn't go away. The patient had the second Pfizer COVID vaccine in the morning around 10:00 AM on 3Mar2021. The pain started the same day on 03Mar2021, then stated that night after midnight and that she thought it would go away. The lump in the arm started a couple of days after the Pfizer COVID vaccine, she thought it was a couple of days but maybe sooner, she didn't pay too much attention. The patient stated the lump felt like it was the size of a nickel, she was pushing to try to feel it and that maybe the lump was a little larger than a nickel. Her shoulder aches and the feeling went into the arm and it started the same week she had the shot but that she didn't pay any attention so is not sure exactly when it started. It was best to check it out with her doctor. The outcome for event pain and vaccination site lump was not recovered, while for remains event was unknown. Information on the lot/batch number has been requested.

Dull headache; Extreme Itching skin; This is a spontaneous report from a non-contactable other healthcare professional (HCP, patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm on 28Jan2021 11:45 AM, at single dose for COVID-19 immunization. Medical history included High blood pressure, known allergies to Sulfa drugs, shellfish. Patient is not pregnant. Concomitant medication included other medications in two weeks. No other vaccine in four weeks. Patient experienced dull headache for exactly 1 week. Extreme Itching skin from 1 week after and ongoing. Mostly in evening. event start date was 04Feb2021 07:00 PM. No covid prior vaccination. No covid tested post vaccination. No treatment received for the events. Patient was not recovered from the events. No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.

First dose of BNT162B2 on 22Jan2021 13:00 and Second dose of BNT162B2 on 08Mar2021 15:00; First dose of BNT162B2 on 22Jan2021 13:00 and Second dose of BNT162B2 on 08Mar2021 15:00; red rash all over her body; This is a spontaneous report from two contactable consumers (patient and patient's husband). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 08Mar2021 15:00 (lot number: EN6205) as single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 22Jan2021 13:00 (lot number: EL9261) at single dose for COVID-19 immunization, and experienced red rash all over her body on 25Jan2021 09:00, had required visit to physician office, treatment with prednisone given, and was recovering. The patient experienced red rash all over her body on 08Mar2021 (reported at "09:00"), which required physician office visit, treatment received with Triamcinolone acetonide ointment. Red rash developed after 1st shot (also reported after 2 days) and after 2nd shot (also reported after 3 days) after vaccination. Doctors had her tab Prednisone. The rash had cleaned up, but 2nd shot caused reoccurrence. She is applying cream now. The outcome of the event red rash all over her body was recovering. No follow-up attempts are possible. No further information expected.

went in for her second dose on Tuesday she also got shingles; This is a spontaneous report from a contactable other healthcare professional. This other healthcare professional reported same events for two patients (patient himself and his mom). This is the second of two reports. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 78 years of age), via an unspecified route of administration, administered in arm right on 13Apr2021 (Batch/Lot Number: ER8729) as 2nd dose, single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine included BNT162B2 dose 1 on 22Mar2021 (lot number: EN6208) (at 78 years of age) for COVID-19 immunisation. The patient went in for her second dose on Tuesday, she also got shingles. It was mentioned that the patient recently got diagnosed today (unspecified) so she was not taking anything currently but she takes some antiviral (not sure exactly what it was). It was clarified that the patient had not yet taken treatment for the event but the reporting other healthcare professional was sure that she will be. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021381912 same reporter/drugs/events; different patients

had blotches on her arm; This is a spontaneous report from a contactable consumer reported for herself. A 78-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 for Covid-19 Immunization. The patient experienced had blotches on her arm on Apr2021. She went to the dermatologist Friday and she didn't think it was that. She stated now that she knows some people might have this, she might mention it to her. The dermatologist prescribed her with a cream. She stated the internet was saying take Allegra or Benadryl. How long does this last. She stated this was with her second dose of the vaccine on 01Apr2021, but this didn't show up until Thursday, 2 weeks later. Therapeutic measures were taken as a result of had blotches on her arm. Outcome of the event was unknown. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.

Caller reports that her right arm is black and blue; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Previously the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient received the second dose of the Covid vaccine on Saturday. Her right arm was black and blue. When she received the first vaccine, she didnot feel anything. When the second vaccine was administered, it felt as they took a dart into her arm or punched her arm. She was unable to utilize her left arm, in which she was unsure if this could have occurred due to having the vaccine in the same arm both times. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

intestinal problems after she eats, and feels like intestinal flu; Balance is off; feeling unwell, just didn't feel good/just hasn't felt right; bursitis in her hands./both of her arms that felt like bursitis; feeling weak, her legs, she could barely stand she had to go to bed; feeling weak, her legs, she could barely stand she had to go to bed; problems with her stomach, intestinal things, intestinal problems; problems with her stomach, intestinal things, intestinal problems further described as lower intestinal; joint pain/shoulders, knees and wrists hurt; Muscle pain; Tenderness; fever; weak; tired; Left arm hurt, injection site pain/tenderness at the injection site; This is a spontaneous report from a contactable consumer (patient) A 78-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 13:37 (Batch/Lot Number: EW0150; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunization. The facility in which the vaccine was given was . Medical history included ongoing arthritis (If she does much your arms will ache/Doesn't take anything for her arthritis, her fingers and joints), hypersensitivity from an unknown date and unknown if ongoing allergy to milk , urticaria from an unknown date and unknown if ongoing (When she gets stressed she gets hives if she does not take her liquid Benadryl she will swell up) , covid-19 from Nov2020 to an unknown date Sick for 3 weeks/intestinal flu, diarrhea, couldn't eat anything/ test oxygen level; knuckles are so big it was registering like 76. Patient's doctor recommended the vaccine since she had Covid virus in Nov2020. Concomitant medication(s) included takes cholesterol and thyroid medication (details not provided); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication from an unspecified start date and ongoing; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication from an unspecified start date and ongoing; calcium (CALCIUM) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took influenza vaccine and experienced influenza, Previously took Aspirin and experienced angioedema. The patient experienced left arm hurt, injection site pain/tenderness at the injection site on 05Apr2021, fever, weak on 06Apr2021, weak, tired on 06Apr2021; joint pain/shoulders, knees and wrists hurt, muscle pain, tenderness on 08Apr2021, problems with her stomach, intestinal things, intestinal problems on 12Apr2021, intestinal problems after she eats, and feels like intestinal flu, balance is off, feeling unwell, just didn't feel good/just hasn't felt right,bursitis in her hands./both of her arms that felt like bursitis, feeling weak, her legs, she could barely stand she had to go to bed on an unspecified date. The adverse events did not require a visit to the Emergency Room or Physician's Office. The patient underwent lab tests and procedures which included body temperature: '100.57 ' fahrenheit on 06Apr2021. Clinical course was reported as follows the patient received the first Pfizer-BioNTech Covid-19 Vaccine on 05Apr2021. On the same day 05Apr2021 her left arm hurt, injection site pain. On 06Apr2021 in the afternoon she had a fever of 100.57 Fahrenheit. She was also very weak and had to lay down because she was tired. She had site pain, joint pain, and muscle pain. With the joint pain her wrists hurt, it was her shoulders, knees and wrists hurt. The tenderness at the site didn't go away until Sunday. She reported her problems with her stomach, intestinal things, intestinal problems, further described as lower intestinal. She started feeling weak, her legs, she could barely stand she had to go to bed. She was tired, started to get joint pain and feeling unwell, just didn't feel good. She felt that just to stand she would fall down, so she had to lie down. Her balance is off, and she felt weak for about 2-3 days, weak is not completely gone but noticed her balance is off a little bit which is ongoing. She just hasn't felt right since she's had the shot. With the muscle pain it felt like she had bursitis in her hands. She had tenderness at the injection site as well as in both of her arms that felt like bursitis, which went away on 12Apr2021 or 13Apr2021. She has intestinal problems after she eats, and feels like intestinal flu. Someone saw her and said she looks tired. On 7Apr2021, she had a visit from the the insurance company doctor and he recommended her not to take the second shot, and that's why she called Pfizer. The second dose of Pfizer-BioNTech Covid-19 Vaccine is due on 26Apr2021 but she's not sure she wants to because she is still recovering from the first one. The clinical outcome of the events Joint Pain, Muscle pain recovered on 12Apr2021, Vaccination site pin Recovered 10Apr2021, Fever recovered 06Apr2021, Weak, tired, balance is off, feeling unwell, just didn't feel good, intestinal problems after she eats, and feels like intestinal flu was unknown, Tenderness was recovered Apr2021, problems with her stomach, intestinal things, intestinal problems was not recovered

A severe irritation, burning and itching all over legs and arms. It was like a sun poisioning or severe sunburn. Dermatologist treated me with a steroid shot and betamethasone cream. Followed up with dermatologist a week later and it had improved but was not fully healed.

Rash with plaques that began on arms less than one week post first Covid-19 vaccination, that continued to spread to legs shortly after. Patient had Lachydren lotion at home, which she began applying before her appointment with her dermatologist, Dr. . At the time of the patient's Dermatology appointment, she was prescribed Betamethasone, Augmented cream to apply BID & refilled Lachydren, and also given an IM injection of Kenelog 40mg.

Rash; This is a spontaneous report from a non-contactable nurse. A 78-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), intramuscular on an unspecified date (at the age of 78-years-old) as 1st dose, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rash, developed the next day after receiving her first Pfizer vaccine, occurring across her midsection of abdomen. It lasted for 2 weeks. No other problems with the vaccination. Reports that her physician recommended that she continue with second dose as scheduled. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.

1 week later - aches (arthritis was worse), leg cramping, general feeling of being unwell seems to come and go still having pain in arm where injection was

sounded like she had shingles; severe pain up her back that goes to her upper torso, left side only; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Mar2021 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 78 years). Medical history included ongoing diabetes mellitus, ongoing degenerative joint disease, ongoing osteoarthritis and ongoing heart disorder. Concomitant medications included tramadol; pregabalin (LYRICA); gabapentin (GABAPENTIN "PCD"). The patient experienced severe pain up her back that goes to her upper torso, left side only on 03Mar2021. The patient also stated that she had sounded like she had shingles on an unspecified date. They felt that the vaccine was trying to fight the shingles virus that stays in her body. She has no bumps, fever or breakout. She went to the Emergency Room once to get pain medicine. She went to her doctor (physician office visit), she doesn't know if he reported this. The events were assessed as medically significant. The patient underwent lab tests and procedures which included MRI, scan and x-ray: unknown results on an unspecified date. Therapeutic measures were taken as a result of pain and shingles. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Shortness of breath, extremely tired, chills. nausea, feeling unwell, lymph nodes, allergic reaction such as rash, extreme itching, swelling of face, loss of taste and smell, severe congestion upon awakening. PCP is out of town entire month of June. Sick of being sick. Must be remedy to all of this! Am not recommending to my friends. I should have never had second vaccination.

Patient said shot hurt badly, arm was sore but felt better after 15 minute observation time. Patient was able to grocery shop after and felt fine. She started to feel bad later in the day and went to bed around 8PM. Patient says she could not sleep, dozed on and off and had chills and sweats. When she woke up at 5:30AM, she said her legs felt like they had been crushed, she was in extreme pain and her legs felt paralyzed and she could not move them an inch. She had to use her arms to move her legs. She states it took her an hour to get to a chair. She sat in the chair for 45 minutes and was then able to gradually prop herself up to a dresser and eventually made it to her bathroom. Her condition gradually improved over time and she was able to walk much better on 5/29, Today she reports no leg pain, but reduced energy levels.

On Wednesday 5/26, days after vaccination I started having a itch on my chin, then a welt appeared and another one came up shortly after. By Friday it spread and got red and itched. The ones that camp on my had itched and on Friday 5/28 my hands started itching and it looked like a beginning of a chicken poc and that evening there was a sore spot by left nostril the spot looked like what was on my hand and it is spreading on my breast, shoulder. On 5/31 there was a spot on my belly button and on the right side of my leg by my groin the red mark was the size of my hand, and on my waist line, then more of the blistery bumps come up on check on face and around right side of my lip and chin and chin line on left side. The doctor provided a steroid cream. I was diagnosed with Hydyshydistic Eczema

rash/hives all over her body, rash became worse; rash/hives all over her body; Itching; This is a spontaneous report from a contactable consumer for mother. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/ Lot number and Expiry date was unknown), via an unspecified route of administration, on 22Jan2021, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient got her first Pfizer Covid vaccine on 22Jan2021 and her second dose of vaccination was due on 12Feb2021. On 22Jan2021, after 1.5 hours receiving the first dose of vaccination, patient developed a rash/hives all over her body (not much on her face, but all over the rest of her body). Patient's HCP recommended Zyrtec that day for the rash and then overnight it became worse, after then HCP prescribed prednisone and hydrocortisone for the itching and Benadryl. After receiving 4 days of steroids, it started to clear up in about a day or 2. Patient was scheduled for second dose on 12Feb2021 and inquired whether she can receive the dose. The outcome of the event was reported as recovered on unknown date in 2021. 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.

syncope; Acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural hematoma up to 7 mm thick; hemorrhagic contusion with edema; hemorrhagic contusion with edema; fatigue; malaise; HA; This is a spontaneous report from a contactable physician. A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 21Feb2021 (Lot Number: EN6200) (at the age of 78-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension (HTN), hyperlipidemia (HDL) and hypothyroidism, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The patient previously took SSRI, PNC (unknown), sulfa and oxycodone; the patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 31Jan2021 (Batch/Lot Number: EL9265) as single dose for COVID-19 immunisation. Within 12 hours of vaccine (on 22Feb2021) the patient developed symptoms of fatigue, malaise, headache (HA) and severe and near syncope. She visited the emergency department (ED) the following day. Work up at that time including blood work and no imaging. She was treated with IVFs and discharged. Symptoms of malaise, fatigue and HA persisted for > 1 week. A computerized tomogram (CT) of the head was performed on 05Mar2021, this CT showed the following: acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural hematoma up to 7 mm thick; 2X3 left front hemorrhagic contusion with edema. The events required emergency room visit and physician office visit. Therapeutic measures were taken as a result of the events and includes conservative measures (as reported). The patient outcome of the event was recovered with sequel.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Shaky; Warm; My face turned red; My hands were shaking; I felt my heart skipping with irregular heart beats; The nurse measured my blood pressure and it was 183/95 with a pulse of 104; This is a Spontaneous report from a Contactable Consumer (patient, self-reported). A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9265 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 03Feb2021 at 08:30 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included hypertension, chronic lymphocytic leukemia, osteoporosis, glaucoma and known allergies: reaction to epinephrine (cannot have Novocain with epinephrine), reaction to histamines and tyramine. Concomitant medications included metoprolol succinate (TOPROL XL), Amlodipine, Levothyroxine, and Atorvastatin. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 03Feb2021, about 7-10 minutes after receiving the shot, she started to feel extremely shaky and warm. Her face turned red, and her hands were shaking. She felt her heart skipping with irregular heartbeats. The nurse measured her blood pressure, and it was 183/95 with a pulse of 104. She was observed for an hour. The patient did not receive treatment for the events. Outcome of the events was recovered on an unknown date in Feb2021. Follow-up attempts completed. No further information expected.

Red rash and blotches on both upper arms; Red rash and blotches on both upper arms; This is a spontaneous report received from a contactable consumer, the patient. A 78-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6208) via an unspecified route of administration on the right arm on 17Mar2021 at 14:00 (at the age of 78-year-old), as single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to Zithromax Z- Pac antibiotics. Concomitant medication include PROLIA . The patient received PROLIA vaccination within 4 weeks of COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced red rash and blotches on both upper arms on 18Mar2021 at 19:00 hours. The patient received treatment for the reported events with benadryl. The clinical outcome of the event red rash and red blotches were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

She got her vaccine, and within a day or two she had a feeling that her mouth was pulling sensation, and has had shingles in the paste. She started using lip balm, and it would loosen up at the beginning. Then, it started getting worse after a couple of days, and started circling her mouth. On 3/5/21 she had a crust around her mouth and went to a doctor and said that she had psoriasis or eczema and told her that she could not treat it. She has a band-aide on her face from the biopsy and has a picture for that. She went to her for 4/5 visits and gave her a hydrocortisone cream and a cold tar treatment, and it stopped for about a week. The cold tar burned to put it on her face, but was doing it, then that stopped. She had an APT on 4/30/21 that she cancelled. Then within the last 7 days it has recurred again. She then went on 6/3/21 to Dr., which was a referral from her PCP, Dermatologist. She demanded her records and he has marked off COVID screen and shingles in a circle and to FU in one month. He has sent her to have patch testing, and to go see a Dr. She informed the doctor of what she has been using for the rash, and he sent her to the other doctor. She has a crack on her nose, and the cream made that area sore. She has had shingles twice in the past. The only place that she has the rash is on her neck upward, her face and seems to be moving to her forehead. The other day it was on the side, and now has moved to the entire forehead. She wears wigs due to the alopecia and seems to be moving up under the wig. She has scaly skin, and crusty skin. He did not diagnose her with shingles, but had it written on his form. She asked if she had shingles and he told her that the Pfizer one had some symptoms of shingles. She has tried eliminating foods, using other problems, and has been taking Benadryl and it's not helping the reaction. He told her to go home and wash her face and not to be put anything on it and that it might go away on it's own, but she has had it for 3 months now. She was very slight near the eyes. Her right eye has had two detached retina and a cataract repair as well, and is worried that if it goes into her eye that she will be blind. The rash is on both sides of her face not one sided. She has put cocoa butter cream on her lips and it seems to be helping her, but was told not to use it. Told her to wash her face frequently and has an APT in a month to have the patch biopsy.

This is a spontaneous report from a contactable consumer or other non- health care professional and health care professional. A 78-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734) via an unspecified route of administration administered in left arm on 03Apr2021 12:45 as single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) and high blood pressure. The patient's concomitant medications were not reported. Previously patient received vaccine first dose of BNT162B2, the lot number was E in left arm on 13Mar2021 at 12:45 for COVID-19 immunization. The patient experienced shingles on 14Apr2021. The event was assessed as non-serious. Therapeutic measures were taken as a result of shingles with valacyclovir. The adverse events resulted in physician office visit. The vaccination facility type was reported as pharmacy. The patient taking COVID 19 vaccine because she did not want to get COVID. The outcome of the event was reported as recovering. No follow-up attempts are needed. No further information is expected.

Arm was very heated. Became red at the site, then spread from elbow to above site and covered 2/3 of upper arm.; Arm was very heated. Became red at the site, then spread from elbow to above site and covered 2/3 of upper arm.; Have a knot about size of ping pong ball; Had flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 24May2021 15:45 (Batch/Lot Number: EWOI86) as single dose for COVID-19 immunisation. Medical history included High blood pressure, high cholesterol, arthritis, nerve damage. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication(s) included benazepril (BENAZEPRIL) at 5mg; rosuvastatin (ROSUVASTATIN) at 5mg; mometasone furoate (NASONEX); gabap (as reported), all taken for an unspecified indication, start and stop date were not reported. The patient previously took vioxx, atorvastatin (LIPITOR) and chlorhexidine diacetate and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on 25May2021, 16.00, arm was very heated. Became red at the site, then spread from elbow to above site and covered 2/3 of upper arm. Have a knot about size of ping pong ball. Had flu like symptoms. The patient used Cold compresses, Tylenol to treat the events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering.

erythematous, mildly itchy confluent macular rash near injection site; erythematous, mildly itchy confluent macular rash near injection site; erythematous, mildly itchy confluent macular rash near injection site; After second dose, had initial mildly sore arm for two days.; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN6202), via an unspecified route of administration, in left arm on 01Mar2021 11:30 (at the age of 78-year-old) as second dose single, for COVID-19 immunization. Medical history included osteoporosis, bladder cancer, status post radical cystectomy with ileal conduit diversion in Nov2020. The patient had no known allergies. Concomitant medication(s) included alendronate sodium (ALENDRONATE SODIUM) and others. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EM9810), via an unspecified route of administration, in left arm on 08Feb2021 at 11:15 AM (at the age of 78-year-old) as first dose single, for COVID-19 immunization and only had mildly sore arm. The vaccine was administered at Doctor's office/urgent care. No other vaccine was administered in four weeks. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. On 03Mar2021 after second dose, had initial mildly sore arm for two days. Two days later on 05Mar2021 noted erythematous, mildly itchy confluent macular rash near injection site. Has persisted to present, but appears to be fading. No other side effects noted. No treatment was given for the events. The events had not resolved. No follow-up attempts are possible. No further information is expected.

Lips tingling/Tongue started to tingle; Face red which felt like swollen; Face red which felt like swollen; Her face "felt tight"; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 26Jan2021 14:00 (Batch/Lot number was not reported) as 1st dose, Single Dose for Covid-19 immunisation. Medical history included Von willebrand's disease Von Willebrand syndrome and Glanzmann's disease and allergies. Family history included bleeding disorder. She was poisoned by pesticides and formaldehyde years ago and they burned her entire respiratory system. There were no concomitant medications. The patient never had a reaction to a vaccine. No vaccines administered on same Date of the Pfizer suspect. No prior vaccinations were given within 4 weeks and no adverse events following prior vaccinations. On an unspecified date of Feb2021, the patient experienced lips tingling, face red which felt like swollen, tongue started to tingle, her face felt tight. The events lasted about 1- 2 hours. Patient wanted to know; can she take a Benadryl before the vaccine. The second dose is due on 16Feb2021 so the first dose was 3 weeks before that one was due. After getting the shot, her lips started to tingle, tongue started to tingle, and her face felt real tight. When the nurse came out to check on her, she was told by the nurse her face was really red. The nurse was going to get an EpiPen and wanted to call EMS. The reporter states she told her to just give her a Benadryl, she normally has them in her car but had run out. Patient stated she was allergic to everything. Anything coming in contact with her respiratory system such as hair spray, scents, any chemical causes her problems. The patient explained that she was re-reading the information about telling the vaccination provider about medication conditions including allergies and bleeding disorder, both of which she has. She was concerned about getting the second dose. She wants to know if the first dose will offer any protection. She had the first dose of the covid shot on 26Jan2021. She started feeling funny. The patient called the nurse and reports her lips were tingling and her tongue was starting to tingle. Her face was really red. Her face felt like it had pressure like it was blowing up but it did not feel swollen, it was tomato red. The patient queried if she does not get the second dose what will that do. She knows there needs to be given a certain amount of time between the doses. She heard on the tv that it can be given up to 45 days and still be effective. She heard all kinds of information, she heard that someone should get the second dose within 28 days and the paperwork states something different. Asked if her reaction will be worse with second shot. She was supposed to go back on 16Feb2021 for the second dose. Patient stated she took Benadryl after her reaction from the vaccine. She wanted to know if this affects the vaccine. Patient mentioned the fact sheet states that patients should tell the vaccination provider if they have a bleeding disorder or are on a blood thinner. She states she has a bleeding disorder. Therapeutic measures were taken as a result of the events. She took a Benadryl for treatment. The outcome of the event was resolved on an unspecified date of Feb2021. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.

This is a spontaneous report from a contactable consumer reported (herself). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration in left arm 28Apr2021 16:15 (at age of 78-years-old) as 1st dose, single dose for COVID-19 Immunization. Patient medical history includes ongoing blood pressure, ongoing (Gastroesophageal reflux disease) GERD reflux, ongoing back pain. Patient had allergies to things like hay fever, pollen, dust, mold. Historical vaccine include Shingles shot on unspecified date and experienced flu. If she had the booster, she would not have shingles. Patient past drug includes Zantac for about 6-8 months ago. Other conditions include scoliosis, has had back operations. She has lost a lot of height due to scoliosis. Patient concomitant medications include irbesartan used for prevention of high blood pressure from unspecified date and ongoing, metformin hydrochloride (METFORMIN ALPHARMA) (1000 mg, 1x/day frequency) used for preventative for Diabetes, she does not have Diabetes from unknown date and ongoing, Famotidine (20mg) taken for GERD reflux from 6 to 8 months from unspecified date, Vitamins taken from unspecified date and unknown till ongoing. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On Apr2021, Patient experienced shingles, pain in her back, rash on lower back which are ongoing and does not feel great, itching or burning in her back was worse. She is unsure if it started the day before or the day of the vaccine. Patient received treatment for events by Mederol/ Methylprednisolone 4 mg for pain as prescribed by the doctor only taken for 1 day/ 6 pills. Also took an Advil the day before and the night of the shot. Patient didn't visit any emergency room but just called her physician. she had a rash on back which doctor confirmed was shingles. The patient had a side effect after the first dose of the vaccine. She asked should I get the second dose. The patient wanted to know if it is accurate that she can delay the 2nd dose up to 6 weeks. She is supposed to get her second dose of Pfizer Covid Vaccine this coming Wednesday, 19May2021, but she still has shingles and does not feel great. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. In response to caller, they suggested to consult healthcare provider they know your health situation and has access to information that can better help inform this decision. Second Pfizer Covid Vaccine shot, she said it is scary, and the doctor said it was scary for her not to take it, all. The Outcome of events was recovering. Follow up attempts are needed. Further information has been requested.

Still itching spots plus left eye is itchy, dry and red; Still itching spots plus left eye is itchy, dry and red; Still itching spots plus left eye is itchy, dry and red; BP was high; high heart rate & MAP; high heart rate & MAP; tired; left side of throat felt swollen; feelings of being "out of sorts"; Small patch of itchy rash just under left arm, itchy stomach, left leg also itchy on varicose veins; Mild nausea; Arm soreness at vaccination site; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in left arm on 14Mar2021 13:15 (at the age of 78 years old) as 2nd dose, 0.3 mL single for covid-19 immunization. Medical history included thyroid nodules, mild macular degeneration, postmenopausal syndrome, high blood pressure (HBP), total hysterectomy w/oophorectomy, gallbladder removal, appendectomy, allergy to penicillin, allergy to contrast dye, allergy to adhesives, and hard of hearing (HOH). Concomitant medications included valsartan (DIOVAN); famotidine (FAMO); pravastatin; estrogens conjugated (PREMARIN); levothyroxine sodium (SYNTHROID); and vitamin D3, all taken for an unspecified indication, start and stop date were not reported. The patient previously took nitrofurantoin (MACRODANTIN), clarithromycin (CLARITIN) and experienced drug drug allergy from both; also previously received the first dose of BNT162B2 (Lot number: EN6201), on 14Feb2021, 13:00, administered in left arm, for COVID-19 immunization. On 14Mar2021 late same day, the patient experienced mild nausea which lasted less than an hour, arm soreness vaccination site. On evening of 15Mar2021, a small patch of itchy rash just under left arm, itchy stomach, left leg also itchy on varicose veins. Upon waking on 16Mar2021 the patient was still itching spots plus left eye was itchy, dry and red; with a bit of nausea, BP was high, no fever, high heart rate and mean arterial pressure (MAP), was tired, left side of throat felt swollen, feelings of being "out of sorts", and her arm no longer hurts at all. The patient took Benadryl and Aleve and all seem better at the moment. She stated she would describe her symptoms as mild although somewhat scary especially the increase in blood pressure and MAP. Her oxygen was normal at 95-97. The patient was recovering from the events.

severe rash/worsened considerably; severe itching; dizziness; swollen tongue; tight throat; even bothering my eyes; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 18Feb2021 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis, neuropathy, heart disease, starts and stop date was not reported for all and patient was allergic with sulfa. The patient's concomitant medication(s) included prednisone; gabapentine and unspecified blood pressure medicine, all are taken within two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 78-year-old at the time of vaccination), via an unspecified route of administration in left arm on 25Jan2021 at 03:00 pm as a single dose for COVID-19 immunisation. Patient previously took simvastatin and had allergies. On 24Feb2021 at 12:00, the patient experienced severe rash and worsened considerably, severe itching, dizziness, swollen tongue, tight throat, even bothering my eyes. Patient received treatment with benadryl then Zyrtec for all events. Patient not received other vaccine in four weeks of vaccination. Patient visited doctor office/clinic visit for the events. Patient had not covid prior vaccination and not tested covid post vaccination. The final outcome of all events was recovering. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

--2 reactions to report: --After the first dose of Pfizer shot, patient experienced shortness of breath immediately after with tight, constricted throat. An hour later reports having severe chills and fatigue which lasted the next 24-36 hours. This then subsided. --After the second dose, patient reports the same respiratory reaction, but this time also had severe pain in the arm at the injection site, along with heat and redness and itch down the arm. 24 hours later patient reports significant swelling in the right breast (patient was being treated for breast cancer with radiation) went to see dermatologist and other doctor to have it examined. They determined that the breast tissue that had radiation is where the reaction occurred. Doctor described seeing several patients on radiation who had the Pfizer shot report the same side effect. Patient reports the inflammation in the breast took several weeks to fade away, estimates 4 weeks. And now still experiences heat and itch in the arm 2.5 months later to this day.

itching; Rash; fatigue; joint pain; low blood sugar; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809/Expiry date: unknown), via an unspecified route of administration on 04Feb2021 at 11:00 AM in the left arm (at the age of 78-years-old) as single dose for COVID-19 immunization. The patient medical history included ongoing diabetes from 2000 and hysterectomy in the year 2000. The patient had received some other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No pre-disposing factors was reported. Follow up received on 21Apr2021, it was confirmed that on 27Feb2021 at 10:00, the patient experienced rash, fatigue, joint pain and low blood sugar (previously reported as, 05Feb2021, 12:00 AM, the patient experienced rash, fatigue, joint pain, and low blood sugar. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient was given advice and reassurance for the treatment of the adverse event). The patient had received treatment for rash. No treatment medication for received for events fatigue, joint pain, and low blood sugar. The patient was not hospitalized as a resulted of these events. Patient reported that the Doctor suggested taking benadryl for itching due to rash. The patient reported that she required a virtual visit to Physician office. It was unknown if the patient had any primary infection site. No culture was performed. The patient reported that she was fine now at the time of reporting. The clinical outcome for the event itching was unknown and the outcome of other events had recovered. Information on the lot/batch number has been requested. Follow up(21Apr2021): This is a follow up-spontaneous report from a contactable consumer received in response to Non-HCP letter via follow-up letter which included: Added patient's age at vaccination, medical history, suspect drug details (Lot number, Time of vaccination), updated event details (onset date and outcome), clinical course and narrative updated accordingly. Follow-up attempts completed. No further information expected.

Rash and hives on upper body; Rash and hives on upper body; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264), via an unspecified route of administration, administered in left arm on 03Feb2021 13:00 (age at vaccination: 78 years) as 1st dose, single for covid-19 immunisation. The patient was vaccinated in clinic The patient medical history included vascular dementia. The patient had allergies to medicines include Neosporin. Concomitant medications included citalopram; donepezil hydrochloride (DONPEZIL) 5mg and atorvastatin 40mg. The patient did not receive any other vaccine in four weeks. On 03Feb2021 13:00, the patient experienced rash and hives on upper body. The patient received Benadryl as treatment for the adverse events. The patient did not get covid prior to vaccination and was not tested post vaccination. The outcome of the events was reported to be recovering. Information on the Lot/Batch number has been requested. Follow-up attempts completed. No further information expected.

Slightly tender; redness at injection site; I went to take off the band aid, it was red, when I put pressure on it, it was slightly tender.It's a light red; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 78-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581 and Expiry date: Unknown) intramuscularly administered in Arm Right on 03Feb2021 11:00 as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient medical history: Exactly 48 hours ago at 11:00 am is when she had the injection. She did not notice it at first. There was a bandage on it and about 20 hours after the vaccination, she went to pull bandage off and noticed it at the site. It was after about 24 hours and was slightly tender if any pressure was put on it. About 20 hours after the injection, there was no more tenderness. The redness remained the same. She measured the area. It is actually a light red, not bright red. On 03Feb2021 the patient experienced redness at injection site. on 04Feb2021 07:00 slightly tender. The outcome of event slightly tender was recovering. The outcome of event redness at injection site was not recovered. The outcome of event i went to take off the band aid, it was red, when i put pressure on it, it was slightly tender, Its a light red was unknown. Follow-up attempts are completed. No further information is expected.

I had itchiness and swelling around my eye. I thought it was a bug bite but it kept getting worse. Eventually, I had a rash around my eyes, my forehead, my hair. I went to the urgent care where they prescribed me an antiviral. The antiviral seems to be slowing things down. I am also now experiencing a crawling sensation throughout my body. It feels as if a bug crawling on me. This is something new that I have never experienced before.

Lump; Redness; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via unspecified route of administration in the left arm on 18Mar2021 at 10:00 (at the age of 78-years-old) as a single dose for Covid-19 immunisation. Medical history included controlled HBP (as reported), diabetes and cholesterol. The patient received other unspecified medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: EL9262) via an unspecified route of administration in the left arm on 25Feb2021 at 10:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The patient previously received Rofecoxib (VIOXX) (no longer made) for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. On 18Mar2021, the patient experienced redness and lump persisting for 5 days. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the redness and lump was not recovered. No follow-up attempts are needed. No further information is expected.

Itching in my scalp; heat bothers it more that the cold weather; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EK9231 and Expiration date was not reported), first dose via an unspecified route of administration on 07Jan2021 (at the age of 78 years) single for covid-19 immunisation. Patient Medical history included hypertension and Heart Attack from an unknown date and unknown if ongoing. Concomitant medication(s) included clopidogrel bisulfate (Plavix, 75 MG), Metoprolol, Benazepril and amlodipine besilate (Norvasc, 2.5 MG) taken for an unspecified indication, start and stop date were not reported. On an unspecified date (4 days after vaccination) the patient experienced itching in scalp which is bothered in heat more that the cold weather. Outcome of the event was unknown. Follow-up attempts completed. No further information expected.

Itching in my scalp; heat bothers it more that the cold weather; the second dose is when it is really been acting up; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of BNT162B2 (COVID-19 VACCINE PFIZER, Solution for injection, NDC/UPC number: Unknown, Expiry date: Unknown) via an unspecified route of administration on 28Jan2021 (at the age of 78-year-old) (Lot number: EL9265) as single dose for Covid-19 immunisation. The patient's medical history included hypertension and heart attack. Concomitant medications included clopidogrel bisulfate (PLAVIX) at 75 mg, metoprolol and benazepril. About the concomitant medication, consumer stated, "she wanted to say it was NORVASC, but did not want to tell wrong. That was going to be amlodipine besylate and that was the 2.5 mg (further not clarified)". The patient previously took first dose of BNT162B2 (COVID-19 VACCINE PFIZER) (at the age of 77-years-old) on 07Jan2021 (Lot number: EK9231) as single dose for Covid-19 immunisation and experienced itching in scalp. It was reported that, itching in scalp; heat bothered it more that the cold weather in Jan2021. Consumer stated, "she had both the shots. One of the side effects said itching. It was settled in scalp. She had itching in scalp, so, was trying to find out if there was anything that she could put on it to stop the itching". Consumer stated, "itching in scalp was about 4 days after the first but it was very lite was not aggravating or irritated or nothing but with the second dose is when it is really been acting up. Heat bothers it more that the cold weather. Cold weather does not seem to itch that much". Regarding lab data, consumer stated, "Not in the last 2 weeks. But they went every three months. They both had the same medical doctor, the cardiologist". She did not take any treatment in response to the event. Outcome of the events was unknown. Follow-up attempts completed. No further information expected.

She got her vaccine, and started feeling real dizzy and stumbling around and cold not do anything, and has had no energy and was in a wheelchair for a little while. She went to her PCP and he told her that she had an infection from the Covid shot, and gave her some antibiotics and some prednisone. This did not help. She was able to walk with her rolling walker before but since then she has had this problem. Her hands hurt, burn, turn red. She drops things steadily. When she gets up in the morning she is not able to do much as she drops things. She still has the same symptoms, and still having no energy and not herself. Her son has now moved in with her to help her as she is not able to take care of herself anymore.

Rash; Fever; Headache; Fatigue; Swollen sore arm; Swollen sore arm; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration in the left arm on 18Mar2021 at 09:45 (at the age of 78-years-old), as single dose for COVID 19 immunisation. Medical history included acid reflux, coronary artery, pre-diabetic and bee venom allergy. Concomitant medication included omeprazole (MANUFACTURER UNKNOWN), levothyroxine (LEVOTHYROXIN), telmisartan (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), cefuroxime (FURO); all for unspecified indication from unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via an unspecified route of administration in the left arm on 25Feb2021 at 09:30 (at the age of 78-years-old) as single dose for COVID 19 immunisation. The patient previously took ampicillin (MANUFACTURER UNKNOWN), azithromycin (MANUFACTURER UNKNOWN), levofloxacin (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN); all from unknown dates to unknown dates for unknown indications and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 17:00, the patient experienced fever, headache, overall fatigue and swollen sore arm that lasted for 4 days. On 23Mar2021, fifth day onwards, the patient experienced rash and patient still had it on 24Mar2021 (sixth day). The patient did not receive any treatment for the events. The clinical outcome of the events fever, headache, overall fatigue, swollen arm and pain in arm were recovered on 22Mar2021 and rash was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.

Nausea; Flu like symptoms; a flare with hands and achiness/sitting for long times everything started hurting; Condition aggravated/flare/a flare with hands and achiness; Bilateral cataracts; Depression; Vomiting; Back pain; Foot pain/fingers hurt; Shoulder pain; Localised erythema; her joints continued to be swollen at times; Diabetes; Heart disorder; Osteoarthritis; Joint range of motion decreased; Lower extremity mass; finger would not bend was straight as a board; Burning finger; one finger was bruised looking; swollen finger on left hand/hand swelling; This is a solicited report from a non-Pfizer sponsored marketing program (MARKETING PROGRAM NAME NOT AVAILABLE) received by Pfizer from AbbVie Inc. A contactable consumer (patient) reported that a 78-year-old female patient received tozinameran (PFIZER BIONTECH COVID-19 VACCINE), dose 2 intramuscular in Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date to Feb2021 at citrate free 40 mg, 1 in 1 week for moderate to severe rheumatoid arthritis and moderate to severe adult crohn's disease. Medical history included moderate to severe rheumatoid arthritis, moderate to severe adult crohn's disease. The patient's concomitant medications were not reported. The patient previously received first dose of tozinameran intramuscular in 2021 for covid-19 immunisation. The patient previously took adalimumab from 05Dec2019 and experienced lack of drug effect; On 16Apr2020, the patient experienced body aches. On 01May2020, the body aches resolved; fatigue from 2019, Urinary tract infection from 2020 to 2020, recovered; recurrent urinary tract infection from 2020. She had another urinary tract infection and she was placed on another unknown antibiotic therapy. On 14Apr2020, the patient was taking ciprofloxacin shot for urinary tract infection however it made her sick and had vomiting, depression and pain and therapy stopped. The patient experienced events of condition aggravated, flare, cataracts on both eyes (bilateral cataracts), nausea and flu like symptoms and non-serious heart condition (heart disorder), osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, joint range of motion decreased, lump on left knee (lower extremity mass), one finger was bruised looking/burning (burning finger) and swollen finger on left hand from 02Mar2021, hand swelling, depression, diabetes, vomiting, after taking covid vaccines, a flare with hands and achiness/sitting for long times everything started hurting, back pain, foot pain, shoulder pain, redness in the hand (localised erythema) and swelling in hand with humira (adalimumab). Pfizer biontech covid-19 vaccine (tozinameran) was considered suspect. She was hospitalized due to extreme flares, body aches, flu like symptoms and nausea. She went to the eye specialist and was diagnosed with cataracts. she was told by her primary physician that she had a heart condition. she reported that her joints continued to be swollen at times and painful. She had shoulder, back pain, foot pain and also had osteoarthritis that affected her knees and hands. She took humira weekly and thought humira helped with pain. She also had diabetes. She stopped humira after taking covid 19 vaccines. She had swelling and redness in her hands and lump on her left knee. Her fingers were swollen, hurt and look bruised. she could not bend two fingers on left hand and thumb. she feels that all of her symptoms started after the second Pfizer covid 19 injections. She developed body aches and a flare with hands, achiness and restarted taking her humira. In 2021, she had cataract surgery on both eyes and had the outcome for the cataract surgery on both eyes was reported as recovered. when sitting long times, everything started hurting. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient was treated with kenalog, prednisone and amoxcillin. The patient underwent lab tests included body temperature: normal value. The action taken in response to the events for adalimumab was unknown. The outcome of events flare, cataracts, nausea, flu like symptoms, was recovered; everything started hurting, back pain, swelling of fingers was not recovered; other events was unknown. The report was considered involved or prolonged inpatient hospitalization and other medically important condition. Causality for humira (adalimumab): the reporter's causality for the event(s) of flare, body aches, nausea, flu like symptoms, depression, vomiting, lack of effect and urinary tract infection with humira(adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of cataracts on both eyes, heart condition, fatigue, osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, lump on left knee, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, diabetes, another urinary tract infection, after taking covid vaccines and developed body aches and a flare with hands and achiness/sitting for long times everything started hurting, back pain, foot pain, shoulder pain, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, redness in the hand and swelling in hand was not provided. Abbvie's opinion is that there is no reasonable possibility that the events of flare, cataracts on both eyes, fatigue, osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, lump on left knee, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02 mar 2021, depression, diabetes, vomiting, lack of effect, after taking covid vaccines and developed body aches and a flare with hands and achiness/sitting for long times everything started hurting, back pain, foot pain, shoulder pain, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, redness in the hand and swelling in hand are related to humira(adalimumab). Abbvie's opinion is that there is a reasonable possibility that the events of body aches, nausea, flu like symptoms, urinary tract infection and another urinary tract infection are related to humira(adalimumab). Abbvie's opinion is that the event of heart condition is not assessable. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed; information about batch/lot number cannot be obtained.; Sender's Comments: Reported events nausea, flu like symptoms, and vomiting are assessed as related to the suspect drug based on drug safety profile and temporal association. Other events are probably associated to patients underlying condition and are not related to BNT162B2. Case to be re-assessed upon receipt of new information.

Two days after COVID vaccine, patient suddenly lost a tooth, despite having no prior dental issues. Then her face ended up developing a long last swelling and rash episode that lasted for 1.5-2 months. Patient thinks it was a reaction to the amoxicillin she was given, but it persisted despite not being on the medicine, being given steroids, and antihistamines. Patient was in the ED twice for the facial swelling. Also saw Dermatology. Pt later saw an allergist and she is not allergic to amoxicillin, only other new thing had been the vaccine when it all started. Then the patient suddenly develops severe bradycardia to the point of syncope and episodes of sinus arrest. Patient then ended up requiring a pacemaker to be placed.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Seizure-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe

Patient started to have trouble breathing around February 10th. She also complained that she couldn't swallow very well since the 2nd vaccine on February 2nd. On February 12 she called in a panic. Her lips were swollen and then her tongue started to swell. I took her to the ER where they sent us to a large hospital. They ran all sorts of test. Blood work, CT Scan, ultra sound. No one could tell me why this was happening. They gave her antibiotics and steroids and the following morning on February 13th she was discharged. The next morning on February 14, patient called me again in a panic. She couldn't breath and couldn't swallow. Her lips, tongue, and under her chin were swollen, hot, and hard as a rock. I rushed to get her and took her back to the hospital. She was in the ER for about 8 hours where she was almost intubated as her airway was close to closing off. She was moved up to the ICU that day and stayed in the the ICU until February 19th. During that time, they ran all the same tests, blood work, CT Scan, ultrasound and no one could tell me why my mom was having this reaction. After we returned home I received a call from the ICU doctor who was checking on her as they had more patients come in with the same symptoms post covid - vaccine. She advised to file this reaction with all the information I had and told me that patient was not to get the booster if one was required later.

granuloma annulare (annular elastolytic granuloma-type) RASH as a possible side effect from the vaccine; granuloma annulare (annular elastolytic granuloma-type) RASH as a possible side effect from the vaccine; This is a spontaneous report received from a contactable other HCP. This Other HCP reported for a 78-year-old female (patient) that: A 78-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via intramuscular on 15Mar2021 (at the age of 78-year-old) as single dose for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included hx of total nephrectomy and Acid Reflux from an unknown date and unknown if ongoing. Patient not diagnosed with covid-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously took MACROBID [clarithromycin] and experienced drug Allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On unspecified date in Apr2021, the patient experienced granuloma annular (annular elastolysis granuloma-type) rash as a possible side effect from the vaccine. It was unknown that, since vaccination patient tested for COVID-19. Patient was not hospitalised for the events. Event resulted to visit Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events with topical steroid and oral antibiotic. The outcome of the events was reported as unknown. Information on the lot/ batch number has been requested.

Itching; Fever; Malaise; This is a spontaneous report from a contactable nurse. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EW0191 and expiration date: not reported), via intramuscular, in Left Deltoid, on 06Jul2021 at 16:30 at the age of 78-year-old, as DOSE 2, SINGLE for covid-19 immunization at Urgent Care Center. Medical history included ongoing asthma, irritable bowel syndrome, gastroesophageal reflux disease and anxiety pre 2001. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EW0183 and expiration date: not reported), via intramuscular, in Left Deltoid, on14Jun2021 at 15:00, at the age of 78-year-old, as DOSE 1, SINGLE for covid-19 immunization at Physician Office and Felt very sick, experienced rash, Sore arm, nausea, fever and malaise. The patient's concomitant medications were unknown. The patient experienced itching, fever and malaise on 05Jul2021 (as reported). No treatment was received for the events. The outcome of the events was recovered in Jul2021. Follow-up attempts are completed. No further information is expected.

It is very red on the top and the bottom of the both the hands; Hand rash; This is a spontaneous report from a contactable consumer reporting for the mother. A 79-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, EL3246), via an unspecified route of administration, on 02Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 79-years-old. Medical history included diabetic. Concomitant medications included insulin glargine (LANTUS) and insulin lispro (HUMALOG) for diabetic. The patient got the vaccine on 02Jan2021 and she had no side effects or anything but the morning on 03Jan2021 when she woke up her hands have rash and it is very red on the top and the bottom of her hands, both the hands. She always has lab work done. Outcome was unknown. No treatment was received for the event.

Resident had seizure like activity followed by a vagel response with large bowel movement. Resident then began to show signs of blood clot to left lower extremity. No pedal pulse, area on leg warm to touch. Left lower leg now cold to touch, stiff, purple and white in color. No other signs of modeling, body warm to touch, no fever noted. Respirations and pulse increased with low oxygen levels. Resident not responding to stimuli.

muscle pains-runs down left leg/thigh, chills, arm pain soreness after vaccination along with itching, frequent urination

WITHIN 5 MINUTES AFTER VACCINATION :SWOLLEN LIPS,DIFFICULTY SWALLOWING ,SENSATION OF THROAT CLOSURE, DI FUSE RASH (ARMS ,LEGS ,BACK) ,SWOLLEN NOSE AND FACE AREA AROUND.

Client verbalized redness and tingling at the vaccination site. Client was evaluated by onsite. Client was released to go home at 10:34 am once symptoms resolved.

Itching began about 48 hrs after injection. Started in eyes and palms if hands but eventually spread over entire body. Took a Claritine which gave no relief. Calked Dr. office and they advised me to go to urgent care. Which I did. Had the severe itching for about 3 hrs. No difficulty breathing or swallowing. Given IV fluids, normal saline and IV diphenhydramine ( up to 50 mg), methylprednisone 125mg and famotidine 20mg. Got relief quite rapidly.

That evening I noticed a round bruised-looking circle above the area on the left shoulder where the shot was given. The next day I noticed these same circles on the inside of my left arm, 3 of which felt like a pinpoint knot where they were (attaching pictures). I can still feel the knot. After a day or two I found 2 more on my right leg (one on the thigh and one down on the leg.) I don't recall any little knots on these two. I do not feel all of these areas spots are bothersome or worrisome but I was told by my daughter to notify the County about them. I do take Plavix every day and have since 2003 which I feel may have caused this reaction.

Activation of dormant shingles. A course of Valacyclovir and Prednisone for seven days. Seems to be controlled.

Horrible rash that started in the underarm area and progressed to upper theigh area in about 3 hours. Rash on back, arms, hands, stomach, upper legs. Call the clinic and the lady who answered the phone found a doctor and asked what I should to. The doctor suggested taking Bendryl. I also washed the areas with soap and water which seemed to help. In the morning I took a bath with baking soda; this also eased the rash. I am continuing to take Benadryl, 1 tablet every 4 hours.

rash on both arms at the site of the nicotine patch; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (lot number: EL3249) first dose on 19Jan2021 10:00 o left arm at single dose for want to be safe. Co-suspect product included nicotine transdermal system patch (lot number: 50430, expiration date: Mar2023) at 21mg; apply to the skin daily from Dec2020 (since 12Dec2020 or 15Dec2020)and ongoing for help stop smoking. Medical history included surgery on her neck in Dec2020 and states everything was fine and Diabetes. This surgery predates treatment with the vaccine. Family Medical History was none. Concomitant medication included ongoing insulin human, insulin human injection, isophane (HUMULIN 70/30) for Diabetes taking for over 10 years. The patient previously received Flu shot on 10Dec2021 (age 79-year-old female) for immunization. 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. She just got the vaccine today (19Jan2021). Everything went fine. The shot didn't hurt. The process went really smooth. She just wants to get rid of this virus. She waited the time period there and then went home. When she was changing clothes after she got home, she noticed a rash. She had been wearing a nicotine patch. On both arms, in both places where she had worn the patch on her arms there is a rash. Clarified she received the first dose of the Pfizer COVID 19 vaccine 19Jan2021 at 10:00AM in the left arm. She noticed a couple of hours later a rash at the location of where she had previously worn the nicotine patch on both arms. She has been on the patch for a month and has not had any rash before. Adds she is supposed to use alternate arms and change daily. The rash is where she used it the last time. She did wash those places this morning before she had the shot so she thinks there shouldn't be any residue. She just changed it to a new location and there is no rash at the new location of the patch yet. Adds there is no pain or itching, just a rash. She is scheduled 09Feb2021 for the second dose. Mentions she was not sure if she should report but she didn't want another elderly person to get the rash and be scared. She imagines that Pfizer already tested the vaccine with tobacco. Event did not require a visit to physician or ER. The outcome of the event was not recovered.

swollen arm as a side effect/Right arm swelling; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number (Lot number reported either EL8982, LL8982, or 6L8982), expiration date unknown), via an unspecified route of administration in the right arm on 15Jan2021 at 14:30 to at a single dose for COVID-19 immunisation. Medical history and family medical history were reported none. The patient had no prior vaccinations within four weeks. There were no concomitant medications. On 15Jan2021, the patient experienced swollen arm as a side effect/ right arm swelling. It was reported that right arm swelling began in the evening. It was also reported that arm was still swollen, but has gotten a little better. The patient asked how long that will last, how to treat the swelling, and if she can go for the second inoculation. The outcome of the event was recovering. Information about lot/batch number has been requested.

Tiredness, swelling at the injection site, headache, sore throat, chills, runny nose and feels overwhelmingly terrible. Feels better today.

This vaccine clinic was held at the Center in on 1/23/21 and hosted by the Hospital.. Vaccine administered at 1340 by LPN. Patient with immediate c/o of feeling light headed, hot all over, flushed. Patient stated she felt better but at 1357 c/o of itching all over body and tongue swelling. Epinephrine pen administered at 1358 by LPN. Emergency services contacted. Patient transported to ER at approximately 1410.

believes it has a little fever; Got the first shot, there was a little soreness; Redness at the injection site for about 4-5 days; The rash is back/ Injection site rash is getting bigger; little itchy/ Itchy with a lump in it; Itchy with a lump in it; Little swollen at the injections site; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246) intramuscular on the left arm from 07Jan2021 at a single dose for COVID-19 vaccination. The patient had no medical history. There were no concomitant medications. The patient reported that she got the first shot and noticed redness at the injection site for about 4-5 days in Jan2021 and then it went away. Reported that 2-3 days ago she noticed that the rash was back or the redness at the injection site was back and itchy with a lump in it. She reported that the spot was 2 inches in diameter then went to 3 inches, so it was enlarged. She was asking "should I put something on it?" and "the next shot is on the 28th, should I get it?". She got the first shot on 07Jan2021, there was a little soreness. It took it from then until Monday for the redness to go away at the injection site and it did go away but then last night she was putting on lotion and she looked on the arm there it was back again there was a 2 inch red circle and it looks like it has little rash type thing in it and it was itchy. She had a redness and it looked little swollen at the injections site (Jan2021). She noticed the injection site rash was getting bigger, referring to the little rash around the site, and it was a little itchy and she believed it has a little fever. Added it was 2 inches and now it was 3 inches. Outcome of the events vaccination site pain and vaccination site warmth was unknown, while not recovered for the other events.

Her skin is a little more rough and more leathery than normal; developed rash at injection site, 'very, very' itching and red, puffy and raised at the injection site; developed rash at injection site, 'very, very' itching and red, puffy and raised at the injection site; developed rash at injection site, 'very, very' itching and red, puffy and raised at the injection site; developed rash at injection site, 'very, very' itching and red, puffy and raised at the injection site; bruise; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), via an unspecified route of administration on 11Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included ongoing allergic to penicillin. There were no concomitant medications. On 12Jan2021, the patient experienced bruise/ She had a little bit of a bruise from the shot initially. On 18Jan2021, two nights ago, it was reported that the patient developed rash at injection site/rash by the site, 'very, very' itching, it itches a lot and red, puffy and raised at the injection site. On an unspecified date, it was reported that the patient's skin is a little more rough and more leathery than normal. Therapeutic measures were taken as a result of vaccination site pruritus. The outcome of the event Her skin is a little more rough and more leathery than normal was unknown while not recovered for the other events.

got my vaccine yesterday/did have an allergy; my shoulder down to my elbow it is very sore and swollen. It is very sore and swollen for some days but it is just in the area where they gave the shot; my shoulder down to my elbow it is very sore and swollen. It is very sore and swollen for some days but it is just in the area where they gave the shot; This is a spontaneous report from a contactable consumer (patient herself). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. Medical history included severe leg cramps. Concomitant medication included gabapentin. The patient previously took tetanus shot (TETANUS VACCINE) and flu shot (FLU VACCINE) on an unspecified date (reported as November) for immunisation. The patient verbalized, "I just wanted to make sure that this is normal. I got my vaccine yesterday. I waited for 30 minutes because I did have an allergy (further clarification was unknown, hence captured as event), to make sure everything was okay. Nothing happened but after I got home within 2 hours my shoulder down to my elbow it is very sore and swollen. It is very sore and swollen for some days but it is just in the area where they gave the shot. So, I just want to make sure that it's normal." When asked about the treatment, the patient stated, "No I did not I thought about taking some Aleve or whatever but my husband and I decided to wait till this morning and call to see that if it is normal like I said like a tetanus shot or flu shot. I am very sore in that area about 5 days but this was little different that it swelled from my shoulder to my elbow. I do not feel sick, I am not dizzy, and I am not short of breath. I read everything that they ask that they said you have a concern to call." Clinical outcome of the events was unknown. Information on the lot/batch number has been requested.

injection site pain, subsiding as of 3 days later; upper arm tenderness, continuing ; entire arm noticeably swollen down into hand, still present.

Soreness at the site in injection. Couldn't sleep that entire night. Woke up with sweats and chills. Felt absolutely exhausted the following day with little to no appetite. Slept soundly (unusual for me) that night and felt absolutely fine the next day.

Initially some soreness and swelling which went away by day 3. Then 9 days after injection, here was a swollen warm, itchy, sore, 2-3 cm red spot at injection site. It slowly faded over the next few days and is not visible on day 12.

According to patient he began having intense shoulder pain 2 days after his Covid vaccine. 1 week ago he saw Dr. (orthopaedic physician) who diagnosed him with SIRVA. He was told that the injection was given too high in his arm. HIs arm is improving, but he does continue to have some discomfort.

soreness at site; swelling at site; fatigue (slept for 12 hours next night); abdominal pain; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) intramuscular at single dose for COVID-19 immunisation on 20Jan2021, at 05:30 PM. The patient did not receive other vaccine same date. Relevant history included apnea, depression, high blood pressure, reflux, 2 strokes, restless legs and allergies with Clarithromycin, compazine, Hydrocodone; kiwi, peppers. The patient was not pregnant. The patient was not diagnosed with COVID prior vaccination. The patient did not have COVID test post vaccination. Relevant concomitant medications in two weeks includes amlodipine, atorvastatin, duloxetine, plus more. The patient did not receive other vaccine in four weeks of vaccination. The patient experienced soreness at site, swelling at site, fatigue (slept for 12 hours next night); abdominal pain (may be unrelated) since 20Jan2021 at 08:00 PM. The events reported as non-serious. Treatment therapy included Acetaminophen. Outcome of events was resolved. Information about lot/batch number has been requested.

Client reports developing shingles after vaccination on right side of face and has right eye involvement. Client reports started with runny nose and watery eyes on 2-1-2021. Was recommended to get COVID-19 testing which was completed on 2-2-2021 and results returned negative. Client was given prescriptions for amoxicillin and prednisone dose pack on 2-2-2021 by COVID testing site practitioner. Client then developed nausea, vomiting and diarrhea after starting amoxicillin and stopped taking it. She spoke with her MD who placed her on another ATB, which she has not taken. On 2-4-2021, she went to the ER as recommended by her PCP for dehydration. The ER noted eye swelling and that she had increased eye pressure after running some tests. She saw her eye doctor on 2-5-2021 and is scheduled for an MRI and MRA on 2-11-2021 and will follow-up with eye doctor on 2-12-2021 as well.

I had no issues with the first dose. When they gave the 2nd dose, I felt strange feeling in my arm. I felt fine after that until the night. About 8PM I got a bad headache, I was so cold all over and I could not get warm, My blood pressure was 153/93. Body aches all over. My skin be sensitive it felt like it hurt to touch my skin. I couldn't sleep last night and was up and down all night. Today I still got a headache. I have been taking Tylenol which didn't help and tried Excedrin. I feel very tired today but I was awake a lot last night. I still have the chills as well.

slight nausea off and on for about a week, rashes on arms and back -- no treatment -- nausea still present occasionally

Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild

Patient had shingles which took a year to resolve and was fully better December of 2020 before she had the first inoculation of Covid. On 1/20/21 had the Pfizer jab and on 2/9/21 the shingles rash had returned in the same area as before. Redness, edema, and complaint of itchy patch.

Burning sensation on skin on Feet on Back; Burning sensation on skin on Feet on Back; Burning sensation on skin on Feet on Back; This is a spontaneous report from a contactable 79-year-old female consumer (patient). A 79-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration in left arm on 28Jan2021 10:45 at single dose for covid-19 immunisation. Medical history included embolism in 2012 and cardiac pacemaker insertion in 2019. Concomitant medication included warfarin (unknown manufacturer), levothyroxine sodium (THYROXIN) and lisinopril (unknown manufacturer). The patient previously took lidocaine and ciprofloxacin and experienced drug hypersensitivity. The patient previously received the first dose of bnt162b2 for covid-19 immunisation and experienced four small raspberry type "burn" left arm and small taste in mouth. The patient experienced burning sensation on skin on feet on back on 28Jan2021 with outcome of recovering. The patient was not treated for the event. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112990 Same reporter/patient/drug, different events

First adverse event on 2/14/21 through 2/15/21 - severe fatigue, headache; second adverse event 2/17 pain in arm at injection site with moderate fatigue and headache .

swelling/brusing, postulate at point of needle insertion, bruising all around. No fever, no itching at this time.

At apx. 1355 this nurse was called to come assess a patient in the monitoring area of the vaccine clinic. Patient was AAOx3 sitting upright in a chair. She complained of feeling itchy on her arms. Patient stated she had a similar reaction after receiving her first covid vaccine when she got to her car to go home. Patient had bilateral erythema noted on antecubital areas of arms. Erythema also noted on her chest. Patient denied any shortness of breath or chest tightness. I advised patient I was going to administer Benadryl IM for the itching. Patient verbalized understanding. EMS was called. At 1359, 50mg Benadryl was administered IM into left deltoid. Patient had received her second Covid vaccine today (Pfizer 30mcg/0.3mL, Lot # EN6200, exp. 6/30/2021). VS assessed: BP 140/80, HR 79, pulse ox 98% room air. Patient stated she had an allergy to topical lidocaine. At 1405, patient verbalized relief from itching. Erythema decreased. Nurse went to reassess vital signs, pulse ox was 98% room air, HR 79. EMS arrived before BP was taken. Patient refused to go to ED for further evaluation. Refusal form was signed with EMS. Patient called a neighbor who came to take her home via private vehicle. Patient stated she has an Epi-pen at home and would use it if needed. Patient was held in monitoring area without further incident until her ride arrived

Developed itching and redness all over body. Eyes itchy and developed hemorrhage; Jaw pain. Patient had COVID-19 a few months ago.

I received my vaccine on Sunday, work up Monday with sore arm which I expected. Monday night around 9pm I had a fever 101.3, my normal pain lever increased bad, and my balance of worse than normal, to walk 20 yards I had to stop at least 5 times because my back was hurting so bad. The next day, I woke up with normal fever but there was redness on the injection site a little larger than a silver dollar, around 8 my fever went up to 100. The next night, Wednesday night my fever was at 99.6, the next day my temp was normal and continued to be the rest of the time. The redness on my arm started fading and has continued to fade but I can still see where it is.

Involuntary shudders I had no control over that lasted 4-5 minutes that left me gasping for my breath. Left arm is quite red and very warm. I was down all day Wednesday & most of Thursday. It so happened that I had a scheduled appointment with my cardiologist on Thursday and checked ok

Itchy and sore patch on upper arm area where injected. Slight swelling and redness of area the size of a typical gauze pad, website gives a good description of my symptoms. Waiting to see if this subsides as it is suggested that it will.

Redness on the thighs, legs, and chest. very little redness on my arm(s). I was watching tv 3 days after receiving the vaccine and my palms were suddenly blue and I could see every vein in my hands and fingers. they were cold and color returned after submerging them in warm water.

to ER on 2/19/21 breathing difficulty, hoarse voice , chest pain, skin itchy, headache, edema, body joint pain, elevated B/P

After two days, had sore arm, sore shoulder and neck. 4 days after very tired,, and felt like had flu for 5 days. Had rash on left arm ob 6 day, still tired but better. 7 day ok.

injection site and arm pain; tiredness; muscle pain; joint pain; feeling unwell; metallic taste in mouth

When making way to the bathroom, patient got dizzy and fell head first onto hardwood floor injuring her face and her knees. This bruised her entire face except a portion of her left cheek. She had already been having muscle and joint pain in her arms and shoulders and had been light headed since her 2nd vaccination. Patient did not make appointment.

When I started to get ready for bed I was overcome with fatigue, and I went to sleep and I woke up two hours later with terrible pain in my muscles and joints, and the injection site was sore. I woke up two other times throughout the night. I was weak, and yesterday the pain was somewhat lessened, but I had an intermittent mild head ache throughout the day, and I went to bed early last night. This morning the ache was still a little achy and tired, but that had cleared up by noon.

pain in the injection site and arm/pain at injection site all the way to her elbow; pain in the injection site and arm/pain at injection site all the way to her elbow; felt like someone stuck a knife in her muscle; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number A3249 and expiry date unknown, via unspecified route of administration at the left arm on 21Jan2021 at single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications included other medications. The patient had the first dose of the Pfizer vaccine on 21Jan2021 and the following day (22Jan2021), she experienced pain in the injection site and arm. The patient informed that it felt like someone stuck a knife in her muscle. The patient informed that the pain was improving and not sure if she wanted to get the second dose. The patient informed that she had a dental procedure done and was taking pain medication to help with that but it didn't help with her pain in her arm from the shot. The patient has been having pain at injection site all the way to her elbow. The patient informed that the first day they it was like she had a shot. The patient informed that it felt like a knife was being stuck in her muscle the second day (22Jan2021). The patient informed that today it felt like pressure. The patient informed that at night time that she sleeps perfect and when she gets up in the morning that it was bad pain. The patient informed that she was leery about getting her second shot. The patient informed that she had two teeth pulled on Friday (unspecified date) after she got the vaccine. The patient informed that they redid her partial for those teeth. The patient informed that they had prescribed 800 mg of ibuprofen for her teeth. The patient stated that she thought it would help the pain in her arm but it did not. The patient was told to keep taking it but she stopped. The patient informed that she has to take antibiotics for her teeth until they were all gone. Therapeutic measures was received by the patient due to the events. The outcome of the events was recovering.

Is anyone tracking reactions to the second dose? Of the 33% who experience a reaction, I didn?t expect to be that miserable. Vaccination site had an odd shaped reddishness. At one point I had on 4 layers of clothing and still shivered so put on my winter coat and tucked a heating pad inside. Temperature was a little above 100 accompanied by aching which all lasted 24 hours.

tingling lips, itchy red cheeks - on the way home Saturday muscle aches from neck to ankles - during the night Saturday to Sunday stuffy nose, dry cough, fatigue, chills (no fever), nausea, sore arm - Sunday and Monday on third day the only thing remaining are chills sought no treatment

shot started to hurt; blood pressure was gone up; Fever; my head feels like it is going to explode; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) solution for injection, via an unspecified route of administration on 29Jan2021 at 08:30 at single dose for COVID-19 immunization. The patient has a lot of medical conditions (unspecified). Concomitant medications included unspecified medications. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 (lot number: EL3286) at single dose for COVID-19 immunization and experienced fever. The patient reported that she had her shot this morning (29Jan2021) at about 08:30 and towards evening, the shot started to hurt and so she wanted to make sure that it didn't go against anything, and put a little ice on it or maybe it was worthless on ice on certain situations after the fact that she thought this was too late. She wanted to make sure she could do that. The patient's blood pressure also went up on 29Jan2021. She was taking several different medicines for blood pressure. She took them already tonight. She was hoping that she will be feeling a little bit better. Sometimes, she gets a little fever on Jan2021, also like maybe 99 (unspecified). She just wanted to know if any of the medications were good or not for the shot. The patient was asking whether the drugs interacted. The patient also reported that when she took her first shot, she had a little fever and asked what she could take for it. An agent stated that she could take paracetamol (TYLENOL). The patient mentioned that she took her pills, otherwise, her head felt like it was going to explode on Jan2021. She took her high blood pressure medicines. She has three medications namely clonidine, losartan and propranolol. She has a lot of medical conditions that was why she was calling because she takes other medications. The outcome of the events was unknown.

nearly fainting; Head ache; fatigue; upset stomach; vomiting; chills; new mouth sores; painful arm; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9365) via an unspecified route of administration in the right arm on 15Feb2021 12:00 AM at single dose for covid-19 immunisation. Medical history included allergy to bees and wasps. The patient was not pregnant at the time of vaccination. Concomitant medications included rosuvastatin and olmesartan medoxomil. The patient previously received first dose of BNT162B2 (lot number: EL1283) via an unspecified route of administration in the right arm on 21Jan2021 12:00 AM at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After receiving the second dose, the patient experienced headache, fatigue, upset stomach and nearly vomiting, chills, nearly fainting and new mouth sores, painful arm on 15Feb2021 13:15. No treatment was received for the adverse events. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Outcome of the events was recovered in Feb2021.

At about 4:45 AM the following day after receiving my second Covid-19 vaccine shot, I experienced a reaction including itchiness all over my body, redness all over my body, abdominal discomfort, diarrhea, vocal changes, lightheadedness, felt hot (but didn't have a temperature, 97.4 degrees Fahrenheit), joint pain. Took Benadryl, and symptoms resolved after about an hour.

Starting about middle of my chest up to my neck it started to get little bit bubbles on it and now it's just burning like crazy and it's starting around my ankles; It's like my chest is burned; This is a spontaneous report from a contactable consumer (patient). A 79-year-old Female patient (also the age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 29Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included Atrial fibrillation (AFib) and back surgery (reported as: I am recovering from very serious back surgery) both from an unknown date and unknown if ongoing. Concomitant medication included methotrexate (reported as , it's a little cancer pill (Further clarification was unknown if consumer have cancer, hence cancer was not captured in medical condition), once a week), tocilizumab (ACTEMRA) (reported as I am on IV Infusions every 4 weeks and the name of it is Actemra), apixaban (ELIQUIS) (reported as I am on Eliquis because I am AFib, heart), and then another heart medicine plus all the patient's 'vitamins' (unspecified). The patient previously took oxycodone and experienced allergy (reported as I can't take any of those drugs, I am allergic to all that stuff. Yeah I can't take any of that pain medicine (Unspecified Medications)). The patient stated that: "I was calling about the, I had my first shot for the virus and on my chest, starting about middle of my chest up to my neck it started to get little bit bubbles on it and now it's just burning like crazy and it's starting around my ankles. Does that have anything to do with that shot?" The reporter confirmed that the next shot is due on 22Feb2021. The patient added that, "Actually last week they were really light, and they just keep getting worst. I was actually going to call my doctor tomorrow because I was concerned about getting this injection anyways because of my history on having reactions to medicine. I can't take any like Oxycodone or like any of those (also reported as "I can't take any of those drugs, I am allergic to all that stuff. Yeah I can't take any of that pain medicine (Unspecified Medications). No, I don't have anything like that."). I can't take any of those drugs (Unspecified Medications). And she said she thought it would be alright but I am recovering from very serious back surgery and so I have had a hard time with that. So, I thought I should call and see if I should get my second injection or if I should just let it go." It was also reported that: "Yes, it's like my chest is burned." Consumer stated for the treatment, "The only thing I put on was Benadryl cream. To keep it from 'itching'." The patient asked "Should I get the second injection?" The outcome of the events was unknown.

Slight sore right arm in shot location; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; EL9267), via an unspecified route of administration in the right arm on 10Feb2021 at 00:30 (at the age of 79-years-old) as a single dose for COVID-19 immunization. Medical history included allergy to latex and penicillin, Afib, asthma and diabetes (under control with diet). Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On an unspecified date in Feb2021, the patient experienced a slight sore right arm in the shot location. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of slight sore right arm in shot location was unknown.

day after the shot her face swelled along with a rash on face and neck took her to the doctor today because her face is even bigger rash worse.

arm swelled up/had arm swelling; little discomfort with the needle; some blood on the band-aid; felt achy in her arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in arm in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that when she got the first dose of the vaccine in Jan2021, she felt that the needle went in, she felt a little discomfort with the needle, had some blood on the band-aid, she felt achy in her arm afterwards in Jan2021; and her arm swelled up/had arm swelling on unspecified date. She did not feel anything with the second dose and there was no swelling like the first time. She asked the nurse if it went in for the second dose and the nurse said it did. The patient mentioned that there was nothing that showed like anything went in her arm when she received the second dose. She heard that the second one should feel something going on more than first time. She did not know if she could get another vaccination or what she needed to do. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Unexpected chest pain along the left side, especially painful the first night. Light pain lasting 10-15 minutes randomly usually once per day on days following date of vaccination. Patient states that it did not feel like heartburn. Patient has never had a heart attack and cannot compare the two experiences. Expected right arm pain at injection site that subsided after a day or two.

On my right leg down close to the ankle I have a swelling that is showing bruising and a lump that is painful. I am not sure if it is a clot or not. I have not been to Urgent care . I informed people giving me vaccine I was on blood thinners. Nobody seem to show concern about that. I have already received 2nd shot, which I got very sick after, but symptoms seem to happen to others. My concern is the lump on my leg if it is a clot and concern if I will get more now that I took the 2nd vaccine.

Rash on face/It was like a bumpy rash, like little pimples but no heads on them/its erupting on the forehead and starting there; It's really red, a red face; Red flushed face; This is a spontaneous report from a contactable nurse (Patient). A 79-year-old female patient received BNT162B2 (BNT162B2; Lot number EK4176, expiry date not reported) via an unspecified route of administration to left arm on 24Jan2021 at 14:00 single dose for covid-19 immunization. Medical history included wheelchair user (She is in a Wheel chair), amputee (she is an amputee, Right leg above the knee, known as "AKA."), leg amputation from an unknown date. There were no concomitant medications. The patient experienced rash on face/it was like a bumpy rash, like little pimples but no heads on them/its erupting on the forehead and starting there on 25Jan2021. Reporter also added it's really red, a red face on an unspecified date and red flushed face on 24Jan2021. The patient underwent lab tests and procedures which included cardiac stress test: unknown results on 22Jan2021 and Nasal Swab: negative on Nov2020 (She got tested about 8 weeks ago and it was negative/test was done end of Nov2020). Therapeutic measures were taken as a result of rash on face/it was like a bumpy rash, like little pimples but no heads on them/its erupting on the forehead and starting there, it's really red, a red face and red flushed face. Reporter stated her rash on the face started on Sunday, it's really red, a red face, it is a blotchy rash on chin, which then moved up to the cheek, and as of yesterday it is now starting on the forehead. Her first dose was on 24Jan2021 at 2pm. She clarifies that it actually started with a red flushed face mainly her cheek on Sunday 24Jan2021, then on Monday she noticed that she thought her chin was breaking out, it was more definite Monday and then faded. By Tuesday it was on her cheeks. It was more definite on Wednesday, it was like a bumpy rash, like little pimples but no heads on them. When queried Weight caller adds that she is an amputee, Right leg above the knee, known as "AKA." Her rash is getting better it goes up the face but its erupting on the forehead and starting there. Caller clarifies it is about the just in different locations on the face. She put cortisone on it. On Friday 22Jan2021, she actually did go for a cardiac stress test, in which they gave her something, radioactive, some medication, since she can't do the stress test running on the treadmill. She has had No Positive Covid test. She got tested about 8 weeks ago and it was negative, it was done via a Nasal Swab, she recalls she got tested prior to a procedure, and so the test was done end of Nov2020. She is in a Wheel chair. The outcome of the event Rash on face/It was like a bumpy rash, like little pimples but no heads on them/its erupting on the forehead and starting there was not recovered. Outcome of all the other events was unknown.

Patient had Pfizer Covid vaccine on 1/13 and 02/03. She experienced rash and blisters on her feet each time.

Uncontrollable shaking, inability to walk, inability to talk, hands hot to the touch, incontinence, inability or desire to eat - all began 4:30pm on the day after first vaccine given (Tuesday 2 Mar 2021) . Patient had to sleep in a reclining chair for 3 nights and was prompted to drink water and was given one Tylenol 650mg. During this time patient needed INCREASED assistance with toileting and could not have a shower with assistance (instead was given a sponge bath). Symptoms lessened over the three days and patient returned to her baseline by Saturday 6 Mar 2021.

Hard red knot appeared immediately at the injection site. Later in the day, the knot became hot. After a couple of days, a red rash about 6 inches in diameter appeared around the injection site. The rash is splotchy and bumpy. It is also hot. The rash continued to get larger. On the 6th day, I took a Benadryl tablet before going to bed. This morning (one week after the injection) the rash is not as hot and the knot seems slightly smaller. There is still swelling.

About one and half hours after receiving vaccine I broke out in was on stomach and back. that was 03-05-2021 Its now 03-19-2021 and I am broken out on body and arms and legs. It feels more like a sunburn and its peeling in spots. Very painful and itchy

rash appeared along a scar line and her belly button; This is an initial spontaneous report from a contactable consumer. A 79-year-old female patient received first dose of BNT162B2 (Solution for injection, Batch/Lot: unknown) in right arm via an unspecified route of administration on 27Jan2021 09:15 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus Verbatim: Diabetic, High blood pressure, hernia repair, big huge scar, had MRSA, tummy tuck. He had a hernia repair and a big huge scar because it went and had MRSA. He had Hernia repair and tummy tuck in England 17 years ago. Concomitant medication included insulin (INSULIN). On 28Jan2021 rash appeared along a scar line and her belly button. Scar was 10 inches long. Rash won't go away, but it was not itching. Rash was not lumpy, but different spots all over. It did not itch. Thought it might be fading, but not sure. Outcome of the event was not recovered.

I am experiencing a large (approx 4") hard swelling at the injection site and the center is approx 2" and very red.

Large bruise (2" wide, 3"long) became very dark noticed ten (10) hours after vaccine injected. Large red rash on arm noticed eight (8) days later, extending above and below bruise. Not itchy. Arm had some pain at site of vaccination day after vaccination.

AFTER THE FIRST SHOT ABOUT 10 DAYS LATER MY RIGHT KNEE AND RIGHT HIP (BOTH HAVE BEEN REPLACED ) WERE REALLY HURTING ME AND I THOUGHT I DID SOMETHING TO HURT IT. AFTER THE SECOND SHOT ON 3/21/2021 I GOT SHINGLES ON 2 DAYS AFTER THE SHOT.

It got to 217/99; I got really red; This is a spontaneous report received from a contactable consumer (Patient). A 79-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 09Feb2021 at single dose for COVID-19 immunization. Patient's medical history included Cancer, asthma. Concomitant medications included letrozole taken for neoplasm malignant, gabapentin, montelukast taken for asthma. Patient received the first dose after half an hour the patient had such subjective symptoms as red, blood pressure had gotten very high after half an hour of Vaccination. It got to 217/99 having somewhat high blood pressure but not that high. Patient went to the emergency room at a hospital they put me on EKG machine to monitor my heart and took some blood samples. Benadryl was given as treatment. The outcome of the events was unknown.

Initial rash on forehead after first injection. After second dose several weeks later she immediately (next day) had hip pain and difficulty walking. It continued to worsen every day. On the 9th day after the second dose she started vomiting. Currently she has joint and muscle stiffness, extreme weakness and fatigue. She can hardly lift up her toilet seat. Her PCP started her on oral prednisone and she is now on 10mg qod.

Joint pain 1st day to present, deep red skin lesions 3rd day to present, welts, head blisters4th day to present, nausea 2nd day, extreme fatigue 1-4 days,

Tightness in chest; dizziness; chills; headache; warm red injection site; warm red injection site; This is a spontaneous report from a contactable consumer (patient herself). A 79-year-old non-pregnant female patent received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration in left arm at the age of 79-years (non-pregnant at the time of vaccination), on 17Feb2021 at 01:30 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot number: EL8982), via an unspecified route of administration in left arm at the age of 79-years on 27Jan2021 at 01:30 AM at a single dose for COVID-19 immunisation. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced tightness in chest, dizziness, chills, headache and warm red injection site on 17Feb2021. The seriousness of the events was reported as no. The patient did not receive any treatment for the events. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Pain in my legs; I developed really bad pain in my legs and one leg is black and blue like all black and blue bruise; Left leg is all bruised; It is all swollen and black and blue and it is like I had tingling going from the ankle bone up to kind of half way in to my calves; Left leg is all bruised; It is all swollen and black and blue and it is like I had tingling going from the ankle bone up to kind of half way in to my calves; there is a little nodule; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6198) via an unspecified route of administration, at the age of 79-year-old, on 18Feb2021, as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included losartan. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: not reported) on an unspecified date, as SINGLE DOSE for covid-19 immunisation and did not have any reaction. On an unspecified date in 2021, like the last week or so, the patient had some pain in legs. The left leg is all bruised and the patient did not hit it, the patient did not remember hitting it but it is all swollen and black and blue and it is like the patient had tingling going from the ankle bone up to kind of half way in to calves. The right leg it is like the ball, the top of it is all kind of shiny and swollen and it is very painful. The patient did not have that before. The patient clarified almost all over the side of legs where the bone is and like to the toes and above the ankle, it is like there is a little nodule that is little sore and same thing is on the right leg. But on right leg, the patient can barely put any weight on it. The left leg tingles and its tender, like the patient have tingling above the ankle up to like half way in to the leg. The patient would like to know if it is possible to have blood clots from the vaccine, it actually looks like a little nodule. The patient underwent MRI on an unspecified date with unknown result. The patient did not receive treatment in response to the events. Outcome of the events was unknown.

The primary symptoms are rash and itching. The primary symptoms do not include shortness of breath, cough, abdominal pain, diarrhea, dizziness, palpitations, angioedema, urticaria, hives or throat swelling. The current episode started 13 to 24 hours ago. The problem has been gradually worsening. The rash is associated with itching. The onset of the reaction was associated with a new medication.

pfizer covid vaccine eua red rash like on legs, arms and back. no pain or body itch. reddness comes and goes.

all over body rash/body rash; This is a spontaneous report from a contactable consumer (patient reported herself). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, NDC number/Lot Number/Expiry date: Not Provided) via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history included bladder infection (took antibiotics). Concomitant medications were not reported. Caller confirmed that she provided lot number during initial report on online portal. Caller stated that she did already go online and fill out the report questionnaire, because she had gotten an all over body rash. Caller stated that she had been taking an antibiotic prior to getting the first dose of the Covid vaccine, but she quit taking the antibiotic on Saturday, and then received the injection on Monday. Caller stated that she was wondering if that could have been a reason for getting the rash. Caller was also wondering if there was a recommendation for her getting the second dose following the side effects she experienced. Caller stated that she did not write down the reference number she was provided when she submitted her report online. There was no product complaint to report. Requested medical information (could an abx have interacted with the vaccine, recommendations on second dose). Caller would like to know if antibiotics would have had an effect on the Pfizer Covid vaccine. Caller received the Pfizer vaccine on Monday but was taking antibiotics for a bladder infection which she quit on Saturday. She got a body rash which lasted Monday to Tuesday. Caller would like to know whether she should get the 2nd dose of the Covid vaccine knowing the side effect she had from the previous dose. Outcome of the event was unknown. Information on the lot/batch number has been requested.

belly cramps; watery bowel; Felt tired; No pain or red at injection site just little tender to touch; This is a spontaneous report from a contactable consumer or other non hcp. A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9263 ), dose 1 administered in Arm Left on 29Jan2021 11:15 as single for covid-19 immunisation. Medical history included breast cancer from 1984 and it was fully recoverd and cured. The patient's concomitant medications were not reported. It was reported that On 29Jan2021 03:00 PM after 3 hours of vaccination patient experienced felt belly cramps, watery bowel. Felt tired, had nap. Much better evening. No pain or red at injection site just little tender to touch. It was reported that all the events were recovered.

Skin bright red from neck down to below buttocks back and front; Down both arms; Very lethargic the entire day; This is a spontaneous report from a contactable consumer or other health care professional (patient herself) of 79-years-old female non pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810, Expiration number: not reported) via an unspecified route of administration on 04Feb2021 14:45 (at the age of 79-years) in left arm as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not known to allergies. Prior to vaccination, the patient was diagnosed with COVID-19. Post vaccination the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Feb2021, patient experienced skin bright red from neck down to below buttocks back and front, down both arms and patient felt very lethargic entire the day. No therapeutic measures were taken for the events occurred. The outcome of events was recovered. No follow-up attempts are possible. No further information is expected.

I had a delayed response to Covid 19 vaccine by one week, March 13th 2021. I had a bright red rash on hand, thighs, buttocks, with small blisters in between fingers and inside upper and lower lips. Also, had hives, welts, and swelling of these areas. Severe itching that did not subside. On March 14th I went to urgent care, by Tuesday March 16th it was worse, went to see Doctor and she increased Pepcid and prednisone dosage that I was given at urgent care. She increased my Zyrtec that I was taking from home and added Singulair. She did labs at this time. I was much better the week of March 21st and advised to see an allergist. Saw him on March 23rd, and he advised no more vaccines until her could test me. So far, April 1st there is no Pfizer vaccine available for test. I'm making another virtual appointment for April 20th.

Developed shakes a few days after shot. Broke out with Shingles on 28/29 of March. Started medicine (IC VALACYCLOV-IR 1 Gram every 12 hours for 10 days) on 4/3/2021 from Doctor. Rash starting to clear up on 4/5/21. Still burning slightly on 4/7/21.

About 2 weeks after administration and patient returned to clinic and complained of left upper arm pain from vaccination that awakes her at night. No warmth or redness. Patient was encouraged to follow up with PCP.

I experienced red rash around where I got the Injection; got the Injection and it was about 2 inches long and 1 inch wide and I still have the itchiness; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 20Feb2021 (Batch/Lot Number: EN9810; 79-year at the time vaccination) as single dose for covid-19 immunisation. Medical history included cholesterol; blood pressure. Concomitant medications included losartan 50 mg; rosuvastatin 5 mg; ezetimibe 10 mg. The patient previously received first single dose of bnt162b2 for Covid-19 immunization. It was reported " I got the Pfizer second vaccine on the 20Feb2021 and I experienced red rash around where I got the Injection and it was about 2 inches long and 1 inch wide and I still have the itchiness." Consumer stated, "No I went on (Search engine) and wash it with soap and water, I have been taking it what you call it Advil or Tylenol. Today the itching is not as bad and pain is gone." The outcome of the events recovering.

couldn't walk straight; use a cane; Guillain-Barre syndrome; left knee and left hip were so painful; equilibrium was totally off; tired; pink blotches and a red rash on her legs; pink blotches and a red rash on her legs; didn't feel good; her legs started burning; her eyes were bloodshot with dark circles; This is a spontaneous report received from a contactable female consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 11Feb2021 09:45 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation. The patient did not have any allergies to medications, food or other products. The patient did not have any relevant medical history. Concomitant medications includes: Plavix (CLOPIDOGREL BISULFATE) 75mg, once a day, Oral, Losartan 100mg, 1/day, Oral for blood pressure high, toprol XL (METOPROLOL SUCCINATE) 50mg, 1/day, Oral for Blood pressure high, ezetimibe (ZETIA) 10mg, once a day for , Oral for High cholesterol. Vitamin C (ASCORBIC ACID) 1000mg, 1/day, Oral. Omega 3 1000mg, 1/day, Oral, taking for 2 years. Vitamin D 1000IU, 1/day, Oral, taking for 6 months. Multivitamin dose unknown, 1/day, Oral. Aspirin (ACETYLSALICYLIC ACID) 81mg, 1/day, Oral. All the Concomitant medications started dates was unspecified. It was reported that Consumer states she got the first dose 11Feb2021 of the Pfizer COVID 19 vaccine at 0945AM in the right arm. Adds she had no reaction the first day. Then about three days later (14Feb2021), she noticed pink blotches and a red rash on her legs; and she didn't feel good. About five days later she called the doctor who did a blood test. No results known. The doctor put her on Prednisone and she took three doses and on Feb2021 her legs started burning so she stopped. Adds she doesn't think it had anything to dowith the Prednisone; it was the vaccine. Reports she started to have balance and coordination problems, on 25Feb2021 her left knee and left hip were so painful that she had to use a cane and could not walk straight and her equilibrium was totally off so that she was she was walking into the wall. Mentions that on 17Feb2021 she was tired, on Feb2021 other eyes were bloodshot with dark circles. Mentions she did lots of research on her phone and decided that all of her symptoms seem to relate to GBS, Guillain-Barre syndrome. Clarifies she does not know if she has GBS. She has been to the doctor again and they are telling her not to get the second dose of the shot. Mentions that pretty much everything cleared up by 1Mar2021. Additional information includes plavix was used for head and neck blockage, taking for 10 years, Losartan patient took off the water pill portion HTZ part of months ago, toprol XL taking for 13 years. Zetia taking for 8 years. Vitamin C patient taking for her immune system, taking for 3 years. Omega 3 taking for 2 years. Vitamin D was taking for 6 months. Multivitamin. Aspirin patient taking for taking for keep blood flowing since 14 years. Outcome of the events didn't feel good, couldn't walk straight and use a cane and Guillain-Barre syndrome was unknown. Outcome of the events left knee and left hip were so painful, equilibrium was totally off and recovered on 01Mar2021. Outcome of the event her legs started burning was recovered on Feb2021. Outcome of the events her eyes were bloodshot with dark circles on 04Mar2021. Additional Information has been requested/ Additional information on lot/batch number has been requested.

Pfizer Covid 19 vaccine: hives/broke out in hives/received the shot on her right arm, but the hives spread on the left shoulder down the arm and forearm; she still has "lizard skin"; has nerve on back shoulder to side and back of arm to forearm to her thumb which is not spasming; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 30Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergic to penicillin and bee stings. The patient's concomitant medications were not reported. The patient previously had flu vaccine and had a flu and shingles vaccine and had shingles for 3 weeks after she took the shingles vaccine. The patient received her first vaccine on 30Jan2021. On 31Jan2021, the patient ended up in ER with hives from the vaccine. She was told that she would be given Prednisone for hives but not to take it until Monday at noon. Stated that they wanted her to wait 48 hours after vaccine before she started it because it would cut it in half. She started Prednisone 40mg on Monday and did get a few more hives on Tuesday and Wednesday. She had the shot in her right arm, and all this happened on the left side of her back. She had a patch of hive of 5x6 to 8x8 on her back and on the back of her arm by her elbow and forearm. She put apple cider vinegar on her arms, and she did not itch anymore. Someone told her that this could be shingles. She stated that she got flu vaccine and got sick with flu and she took the shingles vaccine and got shingles. She could not stand in shower with the shingles but that she can with this, so she knows that it is not the shingles. The patient did not want to take the second shot on 20Feb2021 and wanted to know what Pfizer thinks. She does like to travel and hopes to soon so she wanted to know if not taking the shot could get a stipulation if they required two shots to travel. She has nerve on back shoulder to side and back of arm to forearm to her thumb which is not spasming, but she knows that it is there which came on in the past week (2021). She was on Prednisone 40 mg for 5 days and she still had hives (though they are diminishing). The patient stated that she still has "lizard skin". She received the shot on her right arm, but the hives spread on the left shoulder down the arm and forearm where she had shingles. Her ER doctor told her not to take the second dose and her primary care physician told her to wait and think about it. She is wondering if she should receive the second dose. The outcome of the event hives was not recovered while the other events was unknown. Information on the Batch/Lot number has been requested.

Sore arm; tired; itching; This is a spontaneous report from a contactable Nurse(Patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), dose 1st via an unspecified route of administration on 22Jan2021 as single dose for covid-19 immunisation. Medical history included High cholesterol (Verbatim: High cholesterol). Concomitant medications included rosuvastatin, acetylsalicylic acid (ASPIRIN (E.C.)), zinc, alendronate sodium (FOSAMAX), Multivitamins. Patient had first Pfizer vaccine and the only thing had sore arm and got really tired and the sore arm went away, it descended in about 12 hours and gracely went away, after that it started itching. Patient think she started having difficulty was the morning of 13Feb2021. Patient was not experiencing side effect anymore. Patient did not took any treatment. The outcome of the event was recovered.

thrush on her tongue; cold sore; pulsing in her right ear; States she had a lot of wax; dry skin; earache; This is a spontaneous report from a contactable consumer(Patient). A 79-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261), via an unspecified route of administration on 05Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, It was stated that after the 2nd dose about 2 days later the patient had experienced got thrush on her tongue, she has never had thrush in her life and her doctor prescribed her a swish in her mouth for 4 days, 4 times a day. on the 5th day she got a pulsing in her right ear that started, and she still has that and it seems like just today it may be getting a little dimmer and not as bad and then she had cold sores and has been prescribed with NYSTATIN 1000, she was 79 years old and is healthy. she walks every day for an hour, doesn't take any medications, states her ear doctor wants to do a scan of her head and throat. The patient wanted to know if there are other complaints about ear complaints after getting the shot. And she had also stated that she had a lot of wax and dry skin and her ear was compacted in that right ear. The patient also experienced thrush on her tongue (oral candidiasis), cold sore (oral herpes), pulsing in her right ear (tinnitus), states she had a lot of wax and dry skin and her ear was compacted in that right ear (excessive cerumen production) , states she had a lot of wax and dry skin and her ear was compacted in that right ear (dry skin) , earache (ear pain). The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected

Within 5 days of vaccine the patient became symptomatic with Shingles. Many years had gone by since last bout with Shingles; Within 5 days of vaccine the patient became symptomatic with Shingles. Many years had gone by since last bout with Shingles; This is a spontaneous report received from a contactable consumer (Patient). A 79-Year-old female patient (Pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration in right arm on 16Mar2021 at single dose for COVID-19 immunization. The relevant medical history included pre-diabetic, high Cholesterol, shingles (many years had gone by) and allergies: Penicillin, Statins, Hazelnuts, all from unspecified date. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: EL3247, right arm) on 15Feb2021 at the age of 79 years old for Covid-19 immunization. On 20Mar2021, within 5 days of vaccine the patient became symptomatic with Shingles. Many years had gone by since last bout with Shingles. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab test included nasal swab on 09Mar2021 and 10Mar2021, both showed negative. The outcome of the event was recovering. No follow up attempts are needed. No further information is expected.

Raised skin bumps resembling measles on neck, back, arms, breast and "butt"....none lower. Itching. No fever. Very fatigued.

about 3 inches below site she had a rash/rash was about 3 inches below the injection site; below site she had a rash, It was still red; below site she had a rash, swollen, little bit of swelling; below site she had a rash, it was still little sore to touch; below site she had a rash, itchy; Second day I was still tired; had no appetite; Extreme tiredness; chilling; Small fever of 100.5; dull headache; Slept for about 12 hours; This is a spontaneous report received from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 28Mar2021 at age of 79-year-old (Lot Number: EN6208) at single dose for COVID-19 immunization. Medical history included a little bit asthma, pine allergy, oak allergy, food allergy, 'blood pressure', stroke. Concomitant medications included losartan taken for blood pressure; hydrochlorothiazide taken for blood pressure; omeprazole; fluticasone taken for allergy; acetylsalicylic acid (BABY ASPIRIN); vitamins. The first shot she had, she ended up with a small bruise about the size of a quarter but she did not have any bruise with the second shot. The patient just wanted to report the side effects from the second Pfizer COVID-19 vaccination. She received the second one in the afternoon on 28Mar2021. And on 29Mar2021, just a little less than 24 hours later, it was at about 13:30, she got hit with extreme tiredness and she got in the recliner and got a little blanket and then she started chilling. She did not have the shakes but she couldn't get warm. She ran a small fever of 100.5 and this was for about 4 hours. And she had a dull headache. She slept for about 12 hours out of 16 that day on 29Mar2021. And then, the second day on 30Mar2021 she was still tired and had no appetite and the third day on 31Mar2021 about 3 inches below site she had a rash, swollen and itchy and 01Apr2021 was the fourth day, but it was still sore. The swelling was way down but the rash was still there and it is still itchy. She did take paracetamol (TYLENOL) that first day for the headache and chills. The paracetamol she took was two of them and they were 8 hour arthritic dosage. When paraphrased the concern, the patient stated the rash was about 3 inches below the injection site. It was still red, little sore to the touch, most of swelling down and there was little bit of swelling and red and it had gone down on 01Apr2021. Treatment for events included paracetamol and she had laid down and slept. The outcome of rash, swollen, sore below the injection site were resolving, the red and itchy below injection site was not resolved, the outcome of other events were unknown. No follow-up attempts are needed. No further information is expected.

Developed significant bruising within minutes/hours and has had significant limb pain for 11 days. Also radiating down arm and up into chest and back

1st dose 1/28, second dose 2/21; each time had injection site soreness. 3/26/2021 had onset of pain, joint pain, neck pain, right knee swelling and fever.

left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; little bit of soreness on my left arm where the injection went; This is a spontaneous report from a contactable consumer (Patient). A 79-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 (Batch/Lot Number: EL9269) as SINGLE DOSE for covid-19 immunization. Medical history included blood cholesterol, glucose tolerance impaired, pre-diabetic with HbA1C 6.1. Patient was allergic to Penicillin (swell), Metformin (swell), Sulfa (breathing trouble) and Allegra (headache). Concomitant medication(s) included rosuvastatin, calcium, vitamin D3, vitamin B complex. On 09Feb2021 (Monday, same day of vaccination, patient experienced little bit of soreness on my left arm where the injection went, on 10Feb2021 (Wednesday) left leg went to sleep and when stood up i fell on my left foot; maybe i have just sprained my ankle and there was extreme, swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing (Throbbing pain). The patient was treated with Ibuprofen 200 mg (Intent: Advil) and Aspirin but it was not doing anything to the patient. Patient states that she was usually very healthy and dont have problem with blood pressure. She was prediabetic and just taking care with diet and exercise. Patient was worried if this affect heart in anyway. There was a heart disease on her mother's side of the family, everybody on her side of the family died of a heart attack and patient younger brother has a stent put in and seen other people who have heart problems, and they have the swollen legs and feet and just wondering if that's the same thing that's happening to her. The second dose of vaccine was scheduled for 03Mar2021. The outcome of the events was unknown.

The day after receiving vaccine (2/19) she experienced shortness of breath while shopping at store. She returned home without incident. She thinks she took a Benadryl because that is her usual response. She took a shower on 2/20 and her torso turned bright red from neck to waist - she remembers taking a Benadryl for this - the redness disappeared within about 20 minutes and has not returned. She called her doctor on Friday, possibly Monday she thinks. The MD office called and had her come in on Monday 3/8 for an evaluation. The SOB continues even now. It is worse with activity.

1st day: sleepy; 2nd day: some achiness at injection sight; 2nd day: some achiness at injection sight and body; 3rd day: occasional light diarrhea; discomfort; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself). A 79-year-old female (not pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200, Expiration date: Not reported) via an unspecified route of administration in the left arm on 18Feb2021 09:45 as SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (OMEPRAZOLE) and paracetamol (TYLENOL 8 HOUR). The patient experienced on 18Feb2021 13:00; 1st day: sleepy, 2nd day: some achiness at injection sight and body, 3rd day: occasional light diarrhea, discomfort. The patient was not tested for COVID-19 prior to vaccination and after vaccination. The patient has not received any other vaccine within four weeks. The patient was treated with Tylenol and Pepto-Bismol. The outcome of the events was recovering.

No to little reaction to first shot. Developed severe case of SHINGLES within days after second shot on 202/25/21. Shingles developed despite patient having received the Shingles 2-shot vaccine in 2018.

"Pfizer-BioNTech COVID-19 Vaccine EUA" - received first dose 2/25/2021 and second dose 3/18/2021 Patient wint intermittent persistent occipital headache for 2-3 days. Pain was rated 8/10. Also with bilateral lower extremity rash without itchiness persisting for 2 days. no vision change, no photophobia. Denied any fever, chills, SOB, cough, loss of smell or taste, myalgia, nausea, vomiting, diarrhea, weakness or any focal neurological deficit. Admitted for ITP (also with epistaxis and severe low platelets, hyponatremia, acute cystitis without hematuria. No chest pain, no GI bleed.Treatments included 2 units PRBC transfusion (4/6), plateletpheresis (4/6), dexamethasone IV (changed to prednisone oral on 4/7), IVIG infusion from 4/5 to 4/7, and B12 replacement. Discharge home with prednisone oral, folic acid, cyanocobalamin

sore arm; more of a tingle/tingling arm; like a nerve, maybe she hit a nerve; injection site pain; injection site swelling; injection site redness; This is a spontaneous report from a contactable consumer (husband). A 79-year-old female patient (unknown pregnant at time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 in the arm as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunization. On unspecified date, patient still had a sore arm, she just wanted to shake it, more of a tingle, like a nerve, maybe she hit a nerve. Patient saw her PCP doctor last week (Apr2021) and she was told that it sometimes happened. Patient experienced tingling arm 1 month after 2nd injection. She also experienced injection site pain, injection site swelling or redness on unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

painful muscle; joint aching; temperature of 99.4; injection site pain; dizziness; general feeling of malaise; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 18Feb2021 at 10:15 (at the age of 79 years old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis and fibromyalgia. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had allergic to penicillin. Concomitant medications included Levothyroxine .075MG, Losartan 25MG and Eye vitamins. 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 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EL1283) in left arm on unspecified date for covid-19 immunisation. On 19Feb2021 at 12:30 the patient experienced 15 hours after the second dose COVID 19 vaccine I had painful muscle and joint aching, temperature of 99.4, injection site pain, dizziness and general feeling of malaise. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature 99.4 on 12Feb2021. The outcome of the events was recovering.

vary sore arm; pain in part of the neck; bad headache; Injection site swelling; Injection site redness; Nervousness; Feeling unwell; Arm pain; Vomiting; Her neck hurts; Her hurting shoulder; This is a spontaneous report from contactable consumer. A 79-years old contactable female consumer (patient) reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EW2171), via an unspecified route of administration on 27Apr2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on 27Mar2021 for covid-19 immunization (first dose and lot number- ER8732). On an unknown date, the patient experienced very sore arm, pain in part of the neck, bad headache, injection site swelling, injection site redness, nervousness, feeling unwell, arm pain and vomiting. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

her arm was sore near the injection site; then the soreness spread to her shoulder; she can barely move her arm and shoulder; She added she is in "excruciating pain";; it is "terrible" and "debilitating".; her arm pain; This is a spontaneous report from a contactable consumer (reporting for herself). A 79-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunisation. Patient medical history included spinal stenosis from an unknown date and unknown if ongoing. Patient concomitant medications were not reported. Patient persistently asked what to do to manage her symptoms from the Pfizer-BioNTech COVID-19 vaccine. She explained her doctor said he cannot help and has not seen this before. She then threatened to call her lawyer if a doctor or scientist from the company could not assist her. It was stated that patient received the second dose of the Pfizer-BioNTech COVID-19 vaccine on 26Feb2021. She explained a few days after, her arm was sore near the injection site, then the soreness spread to her shoulder and she can barely move her arm and shoulder. She added she was in excruciating pain; it is terrible and debilitating. She took pain medicine for the arthritis in back and described it as spinal stenosis. She mentioned this medication was barely doing something to help with her arm pain. She then specified she also consulted her doctor who prescribed gabapentin and methyl prednisone tablets, which aren't relieving her arm pain. She expressed her concerns on the persistence and intensity of her pain. She asked if her symptoms were reported as side effects to the vaccine. Patient expressed her disappointment on the lack of information provided to manage her symptoms from the Pfizer-BioNTech COVID-19 vaccine. She said she was excited to get this vaccine among the other brand, and now that she is injured from it, she feels like Pfizer should be by her side and thus claims to have help from Pfizer. Outcome of the event her arm pain and her arm were sore near the injection site was not recovered. Outcome of the other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Herpes Zoster outbreak on R flank, zoster confirmed by culture, treated with valtrex 1 g PO TID x 8 days. Zoster became disseminated, involving the face and arms, valtrex was continued for 14 additional days. Symptoms resolved with mild post-heretic neuralgia follow up on 3/4/21. No outbreak of zoster occurred after second dose of vaccine, which was given 3 weeks after first. Follow up with ophthalmology showed no ocular herpetic pathology.

became symptomatic with Shingles; This is a spontaneous report from a contactable consumer (reporting for herself). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 16Mar2021 at 13:45 (Batch/Lot Number: EN6202) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included Pre-diabetic, Hazelnuts, penicillins, statins allergy and high cholesterol. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL3247) on 15Feb2021 for COVID-19 immunization. On 20Mar2021, the patient became symptomatic with shingles. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 09Mar2021 and sars-cov-2 test: negative on 10Mar2021. The patient did not received treatment for the event. The outcome of the event was recovering. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. No follow up attempts are needed. No further information is expected.

Hypertension; Tachycardia; Extreme flushing to face and neck; glowing red; took her pulse and it was 145; Persistent head to toe macular erythematous Rash; Dull Headache; This is a spontaneous report from a contactable healthcare professional (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered on the left arm on 21Apr2021 13:12 (Batch/Lot number was not reported; Expiration Date: 31Jul2021) as 1st dose, single for covid-19 immunisation. Medical history included fibromyalgia (diagnosed more than 20 years ago), bladder cancer (diagnosed 13 years ago the first time, 8 reoccurrences and has been cancer free for 2 years, cancer free for 2 years), multi drug allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities, diabetes, and obesity. Concomitant medications included lisinopril, levothyroxine, and oxazepam. No vaccines received within 2 weeks. In 12 minutes after the injection on 21Apr2021, while she was still sitting in the parking lot, patient developed tachycardia on and extreme flushing to face and neck on 13:20. They were as red as being in the sun. She was aware of tachycardia first. Then she looked in the mirror and was glowing red. Patient was observing in parking lot and took her pulse and it was 145. Persistent head to toe macular erythematous rash occurred next. They took her to the ER about 20 minutes after the injection. In the ER, she was given 25mg of Benadryl IV and 125 mg of Solumedrol IV. When both of those wore off the next day, the generalized rash came back on Thursday (22Apr2021). The rash was persistent but not as flushed looking as before. When they got her into ER, the first blood pressure reading was 198/117, which was within 20 minutes of injection. Hypertension was experienced on 13:30. Her blood pressure usually was fairly low and was back to normal now. She had one reading of 124/76 to 170/something. Her normal range is anywhere between 150-170/70-80's. She is on Lisinopril. The other morning when it was 124/76, was just a fluke. That was an unusually good reading. They did a regular panel of lab work when she went to the ER. They did not tell her that anything was abnormal. She asked them to run an A1C, but they told her they could not. They did a chest film, EKG, placed IV to give medications, but no fluids given. Her doctor said not to get second dose of the vaccine. She had it at the hospital and they had reports of other people with a rash. The patient considered the events tachycardia, extreme flushing, macular erythematous rash and hypertension were medically significant while for headache was non-serious.; Sender's Comments: The reported events were possibly causally related to the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship. This 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.

Pfizer-BioNTech COVID-19 Vaccine EUA - admitted to hospital 04/5/2021with covid-19 after one dose of Pfizer Covid-19 vaccine on 3/18/2021. 79 yo Female received 1st dose of Pfizer Covid-19 vaccine on 3/28/2021. Reactions reported were body aches and soreness at the injection site shortly after vaccine injection. After vaccination, patient found out that 2 of her family members that she lives with had positive Covid-19 tests (health status of these family members unknown). Patient got a covid-19 test on 3/30/21 and it was positive. On 4/2/2021, pt had a telemedicine visit for fever and dry cough. Azithromycin and albuterol prescriptions were given because of concern

Extreme whole body itching with no rash; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9264), via an unspecified route of administration, administered in Arm Left on 22Feb2021 08:15 (at an age of 79-years-old) as single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus. Concomitant medications included metformin (MANUFACTURER UNKNOWN), via an unspecified route of administration from an unspecified date at 500 mg unknown frequency for unknown indication; doxycycline (MANUFACTURER UNKNOWN), via an unspecified route of administration from an unspecified date at 20 mg unknown frequency for unknown indication. The patient previously took bnt162b2 (Product=COVID 19, brand=Pfizer, lot number=EL9265, lot unknown=False, administration date=31Jan2021, administration time=08:00 AM, vaccine location=Left arm, dose number=1). On 22Feb2021 17:00, the patient experienced extreme whole body itching with no rash. The patient did not receive any treatment for the events. The clinical outcome for the extreme whole body itching with no rash was recovering.

itching; swelling; red and swollen,fever in area, 5x6 cm; This is a Spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262 and Expiration date was not reported), via unknown route of administration in left arm on 14Feb2021 at 15:15 (at the age of 79-year-old) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included known allergies. Concomitant medications were not reported. Patient took unspecified other medications in two weeks of vaccination. The patient did not receive any other vaccine in four weeks. The patient had no COVID-19 prior vaccination and not tested for COVID-19 post vaccination. On 21Feb2021 at 12:00, the patient had itching, swelling, red and swollen, fever in area, 5x6 cm. No treatment was received for the events. The outcome of the events was reported as recovering. Follow up attempts are completed. No further information is expected.

shortness of breath; experienced white and pink bumps on her face around her lips; experienced white and pink bumps on her face around her lips; she experienced aches and pain in her joints; blurred vision on and off; This is a spontaneous report from a non-contactable consumer (patient). A 80-years-old-female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 23Feb2021 (79-years-old) as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient did not have her medications, but she did state that she has had several Botox injections in the area on her face where she experienced the reaction. The 2nd day after the first dose of the vaccine (24Feb2021) she experienced white and pink bumps on her face around her lips. She also had some shortness of breath and called 911. She was admitted to the hospital. The ruled out COVID infection and Pneumonia. On the 3rd day while hospitalized she experienced aches and pain in her joints. She was discharged after 3 days. Her symptoms have subsided. She is only complaining on some blurred vision on and off. She received her first dose on 23Feb2021. Her Doctor told her she should not get the 2nd dose. Therapeutic measures were taken as a result of shortness of breath, experienced white and pink bumps on her face around her lips, she experienced aches and pain in her joints. The outcome of event she experienced aches and pain in her joints was recovering, while other events was unknown. It was reported that patient had several Botox injections in the area on her face where she experienced the reaction. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

headache; fatigue; pain at the site; pain at the site, swelling; chills; lethargic; temperature and it was holding steady at 99 degrees; her arm had gotten red and became very hot; her arm had gotten red and became very hot; This is a spontaneous report from a contactable Nurse (Patient herself). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), on 28Jan2021 at 09:15 (Batch/Lot Number: EL1283) (at the age of 79-year-old) as first dose intramuscular administered in arm right unknown dose, single for covid-19 immunisation. Medical history included ongoing Gastric anomalies, ongoing Allergies, breast cancer (also took cancer medication for 5 years but hasn't had that in 2 years), she had 2 implants (ongoing), but she hasn't had any radiation or chemotherapy in the last 2 years. She has arthritis down her spine and a couple other things wrong with her. She states it magnified those conditions and it stayed that way for a while. Her historical vaccine reported Flu in Sep2020. Ongoing concomitant medication included patient states she does have allergies and she does take daily medication for it. She also has a nasal medication, Montelukast and she was also on an oral tablet every day also takes dexlansoprazole (DEXILANT) which was a very powerful antacid for her gastric anomalies. She wasn't supposed to take it but for only 3 months but she has continued to take it for 5-10 years, more like 10 years and no one has stopped her. She states "Patient had a headache, fatigue, pain at the site, swelling but no lymphadenopathy after receiving her first dose. She had cancer in the past but clear now. Patient mentioned she got the first dose on 28Jan2021 and scheduled for her second dose 23Feb2021. Caller wants to know the side effects expected with the second dose. Patient received the first COVID-19 vaccine on 28Jan2021 at 9:15am. Around 2am or 3am the following morning (29Jan2021), her arm had gotten red and became very hot. It became really quite swollen. She couldn't move without it hurting. She took Tylenol without any advice from a doctor, she just took it herself. The Tylenol relieved some of the pain, but not all of it. Patient verifies the Tylenol is not handy when probed for NDC/UPC, Lot number or expiration date. She also started to experience chills but she never took her temperature. So at this point all of this was within 2 days after two 24 hour periods. Patient states on the 3rd day, everything seemed to lighten up and started to back off a bit. She took her temperature on the 3rd day and it was holding steady at 99 degrees. She didn't feel that any of this was earth shattering. She was taking more Tylenol and it relieved some symptoms. The Tylenol did help. By the fourth day, she was almost normal. She was so lethargic. She became extremely lazy and was laying around the TV. She states its all COVID's fault. She continued to have the magnification of her pre-existing conditions. Patient mentions her weight may be a little more than provided. She has been eating ice cream. Patient confirms at this point, she has recovered to her normal self, eating ice cream watching TV and playing with the puppies. The caller confirms the symptoms started letting up and she has recovered. Patient states she had some ablations on her back and muscle spasms. Her muscle spasms are pretty mellow and she hasn't had any treatments in a year and a half. Outcome of the event pain at the site was recovering and all other events was unknown. Events, redness in arm, arm became very hot and swollen, Chills and Lethargic was reported as related. Follow-up attempts are completed. No further information is expected.

R arm, then L (1st) at inject area ache/pain that remains 5/20 & gets worse; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE, lot number: ER8729), at the age of 79 years old, in right arm on 14Apr2021 14:00 at single dose for covid-19 immunisation. Medical history included low thyroid and high blood pressure. Both were medicated. The patient's allergies were unknown. The patient was not pregnant at time of vaccination. The patient was not diagnosed with covid-19 prior to vaccination. Concomitant medications included lisinopril at 20 mg and levothyroxine sodium (SYNTHROID) at 112 ug the patient received within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to vaccination. On 16Apr2021, the patient experienced R arm, then L (1st) at inject area ache or pain, that remains 20May2021 and got worse. The patient had not been tested for covid-19 since the vaccination. No treatment was received. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Hives; Itching; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer reported that she recieved BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EM9809 and Expiration date ; not supplied) via an unspecified route of administration, on 01Feb2021 (at the age of 79 years) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that She got the first dose 10Feb2021. She developed hives the next day 11Feb2021 and they stayed until she went to the doctor at least a week after and got the Prednisone. She was itching so bad. She says they have recovered at this point but another reason she was calling is that her doctor doesn't want to give anymore Prednisone for the next dose, She said they do not want to keep suppressing it. She guesses she will just have to see what's going to happen or maybe she shouldn't have it. The doctor said Pfizer may tell her not to take it. She does not see any expiration date or NDC number, just reminder for the next appointment. Dose: unknown to the caller. She just knows it was dose number 1 and that they went and got it. She says she thinks she will just follow up with her doctor and she also said to let them know when she gets the shot to watch her longer than 15 minutes, she may call them maybe they will just come up with some other medication to give her if she needs it because they do not want to give her Prednisone anymore. She guesses she will go take it and see what happens. She is sorry she could not find her doctor's address. Oh she found the doctor's information. Just so happens she got a piece of mail from them today. Investigation assessment; no. the outcome of events was recovered. No follow-up attempts are possible. No further information is expected.

Developed a rash on front of both legs between ankles and knees; Constant itching; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number FN 6200 RA), via an unspecified route of administration, in right arm on 25Feb2021 at 13:00 (at the age of 79-year-old) as first dose, single for COVID-19 immunization. Medical history included high blood pressure and occasional lower extremity edema. The patient had no known allergies. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) and nifedipine (NIFEDIPINE). The patient received no other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. On 28Feb2021 the patient developed a rash on front of both legs between ankles and knees and constant itching. No treatment was received for the events. The events had not resolved. No follow-up attempts are possible. No further information is expected.

RASH ON VARIOUS PARTS OF BODY, BACK, FINGERS, WRISTS ETC; ITCHING ON VARIOUS PARTS OF BODY, BACK, FINGERS, WRISTS ETC; This is a spontaneous report received from a contactable consumer, the patient. A 79-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via unspecified route of administration in the left arm on 08Mar2021 at 14:00 (at the age of 79-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included chronic obstructive pulmonary disease, diabetes, asthma, arthritis etc (as reported) from unknown date to unknown date. Concomitant medications include metformin (MANUFACTURER UNKNOWN), glimepiride (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), unspecified medication "D and B", all from an unknown date for an unknown indication. Prior to vaccination, on an unspecified date, the patient was diagnosed with COVID-19. The patient was not tested positive for COVID-19, since having the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient had allergy to Penicillin. On 09Mar2021, the patient experienced rash and itching on various parts of body, back, fingers, wrists etc. No therapeutic measures were taken for the reported events. The clinical outcome of the events rash and itching were not recovered. No follow-up attempts are needed. No further information is expected.

she developed a red rash from her knees to her ankle, and from the elbow to the wrist; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Right Arm on 03May2021 10:55 AM (Lot Number: ER8735) as 2nd dose, single for covid-19 immunisation. Medical history included ongoing diabetic (diagnosed at least 12 years ago), she has breathing problems (she is not allowed out in public even after her vaccination). The patient's concomitant medications included she has been taking the medicines now for a while, she did not feel like it was a reaction to any of that. Historical Vaccine included Patient gets a flu shot every year for immunization; she also received the first dose of BNT162B2 (at age of 78 years old, lot number: EP7533) on 31Mar2021 injected before noon at right arm for COVID-19 immunization. Patient has received both doses of the Pfizer Covid 19 Vaccine. The second vaccine was received on 03May2021. Patient reports that on 18May2021 she developed a red rash from her knees to her ankle, and from the elbow to the wrist. Caller denied stinging, pain, or burning. She also denied any changes to detergent. Caller asking if symptom has been reported. Patient calling to see if she is having a reaction to the Covid vaccine. Patient states she is calling because she at her wits end, she had her second shot on 03May2021 and maybe three days ago now, she started breaking out with a red rash, it does not sting, burn, or hurt but it was from her knees to her ankles and from her elbows to her wrist. Patient states thought everything they can think of and she has had no new laundry detergents or eaten no new foods. breaking out with a red rash: Caller states she would say this past Tuesday and it seems to be more predominant when she takes a shower, with the warm water it seems to bring it back out. Caller states she has been taking some Benadryl. Patient states like she says, its just there, it did not sting, it did not itch, it did not burn, she just looks down at her arm or leg and it was kind of weird looking. Pfizer Covid Vaccine: No Investigation Assessment. The event was not required a visit to Emergency Room nor Physician Office. Outcome of the event was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

eyes really burning and watering, she almost could not see; eyes really burning and watering, she almost could not see; she almost could not see for a few minutes; Tiredness; excruciating pain in all 10 fingers, just to the area that connects to the hand, nothing in her palm or hand; red mark about the size of a quarter at injection site; couldn't move her fingers; This is a spontaneous report from a contactable Nurse. A 79-year-old female patient received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EW0150; Expiration Date: 31Jul2021), dose 1 intramuscular, administered in Arm Left upper on 24May2021 11:30 AM (at the age of 79-year-old), as 1st dose, 0.3 ML single dose, for COVID-19 immunization. Medical history included first pulmonary embolism in 2007; second in 2017 Went to hospital 23Jan2017, left hospital 5 days later. Patient has allergy to aspirin from Dec1982 to ongoing. (Patient Had headache, took Aspirin in 20 minutes had severe reaction-like never seen. Did not go to hospital, never felt throat closing off, coughing, trouble breathing. Skin felt on fire inside and out, took everything off, ice cold shower, skin beet red felt on fire all over, skin looked like elephant skin, wavy; Neighbor nurse gave her liquid Benadryl she drank. Within 15 minutes everything started to clear up, never been near Aspirin again). Patient has allergy to Advil from 1985 To Ongoing. (Had Severe reaction. Did not go to hospital, never felt throat closing off, coughing or trouble breathing. Couple years later had new job picked up fever from little kids coming in. Took Advil had reaction started the same way as with Aspirin, but she had Benadryl at home and able to catch it in time. Never taken again). Patient has allergic to other things, has environmental allergies. She kept Benadryl in her purse. Patient had Gall bladder surgery from 1985 to Unspecified date. (When had gall bladder taken out, they gave her Percodan and Percocet in hospital, had reaction of rash so they had to take her off Percodan and Percocet and give her Benadryl). Patient had Titanium filter in place from 24Jan2017 to ongoing. On 23Jan2017, patient was hospitalized because she could not breathe with pulmonary embolism, they put titanium filter in place probably after midnight so on 24Jan2017. Patient had lumbar stenosis with pinched nerve from 49 years of being a nurse. A few years ago, she had 2 procedures where they would inject long-acting unknown product, she guesses Cortisone but did not know the name of the product she guesses Cortisone but does not know the name of the product. On her right hand the numbness was still there. Patient underwent EMG test and a couple weeks later he told her he thought she has carpel tunnel. The concomitant medications include Eliquis taken for pulmonary embolisms (2.5 mg, 2x/day) from unspecified date of Jan2017 to ongoing. Synthroid taken for thyroid problem from unspecified date to unspecified date. Eliquis has to be a pretty powerful drug; don't know about Pfizer Covid Vaccines, wondered if something interacted because excruciating pain in all 10 fingers, just to the area that connects to the hand, nothing in her palm or hand and couldn't move her fingers took a little over 4 days after Pfizer Covid Vaccine for onset. The patient previously took (years ago) hepatitis vaccine, shingles vaccine, pneumonia vaccine, no reactions to those; she was very cautious did not leave the office too soon after vaccines. She never got flu shot; when she was first in nurses training, she had a reaction to the flu vaccine in like 1960 and was in the emergency room. This retired Registered Nurse was the patient who called regarding her first dose of Pfizer Covid Vaccine. She reported tiredness; eyes really burning and watering, she almost could not see; excruciating pain in all 10 fingers, just to the area that connects to the hand, nothing in her palm or hand; She couldn't move her fingers. She also mentioned red mark about the size of a quarter at injection site. She reported she had absolutely no symptoms, nothing after the Pfizer Covid Vaccine other than tiredness, feeling kind of tired, that's about it. On27May2021 in the afternoon she had onset of her eyes really burning and watering, she almost could not see for a few minutes. She washed her eyes out, and the burning and watering went away after she washed them. She had no make-up on, no eye make-up on for a few days at that time. Otherwise, everything was ok. She went to bed last night and during the night she woke up with excruciating pain in all 10 fingers, just to the area that connects to the hand, nothing in her palm or hand. She couldn't move her fingers for maybe a minute or two. Eventually she was able to move her fingers a little, then more and more and the event stopped, she kind of went back to normal and fell asleep. A couple of hours later she had the same event reoccur, just down to the hand, all 10 fingers, couldn't move them for a few minutes and then after that she could, they seemed to be ok, and she fell asleep again. Whether event started 27May2021 or 28May2021 is unknown, unknown onset times. She has been fined all day. She has written checks out, made meals, coffee, washed and dressed herself, had no other problems. At her age it was hard to tell when the tiredness started regarding time of onset. Thinks in the evening of 24May2021 she felt onset, tired and the next day on 25May2021 she had a couple episodes where her arms felt really heavy just for a short time maybe 30 seconds and then the episodes went away and she just felt tired. 26May2021 she noticed she was not as tired, and yesterday and today improved, feeling pretty good. Seriousness of all the events was not specified by reporter. The outcome of the events eyes really burning and watering, she almost could not see for a few minutes was recovered on 27May2021. Time of onset: late morning, probably about 11:00-11:30 really burned, then eyes started to really, really water. She was familiar with her house so she held onto furniture to get to the bathroom and as soon as she rinsed her eyes out event never happened again. Her eyes are not bothering her.The outcome of excruciating pain in all 10 fingers, just to the area that connects to the hand, nothing in her palm or hand and couldn't move her fingers was resolved on an unspecified date in 2021. The outcome of the event tiredness and red mark about the size of a quarter at injection site was recovering. Follow up attempts are completed. No further information is expected.; Sender's Comments: Based on close temporal association the causal association between the reported event she almost could not see for a few minutes with the usage of the vaccine BNT162B2 cannot be excluded. The contributory effect of the patient's medical history and concomitant medications also need to be considered. The case will be reassessed should the additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

calcified lump, left breast, inconclusive; weak; tired; chills; shortness of breath; Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear); Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear); lung nodule; This is a spontaneous report from a contactable consumer (patient). A 79-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EN5318), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 as single dose for covid-19 immunization at Hospital. Medical history included atrial fibrillation, mitral valve stenosis, COPD (chronic obstructive pulmonary disease), ,ggo's , asthma, Known allergies to various medications. Concomitant medications in 2 weeks included Atenolol, Digoxin, Atorvastatin, Eliquis, Lasix, k (Potassium). Patient did not receive any other vaccine in 4 weeks. Patient did not had COVID prior vaccination. Patient did not tested for COVID post vaccination. Patient previously received COVID 19, brand: Pfizer-BioNTechCOVID-19 Vaccine 1st dose in left arm with lot number EL3246 on 21Jan2021, at 10:45. In Feb2021, the patient experienced lung nodule. On 19Feb2021 at 10:00 patient had chills. On 19Feb2021, the patient had Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear). On 19Feb2021 at 10 PM the patient had shortness of breath, abating at 4 am. On 20Feb2021, the patient was weak and tired but beathing easily. On 02March 2021, the patient had calcified lump, left breast, inconclusive. AE resulted in Doctor or other healthcare professional office/clinic visit. Lab test included patient had CT scan of lungs on 03Feb2021. On 05Feb2021 mammogram was done. On 09Feb2021 PET scan GGO change, upper left lobe confirms solidifying. On 02Mar2021 repeat mammo, results calcified lump, left breast, inconclusive. Bronchoscopy was scheduled for biopsy of GGnodule on 18Mar2021. On 19Feb2021 weight at 9 am was 127.5 lbs. On 21Feb2021 weight at 9 am was 120.0 lbs. Itchy lumps disappear 1 week. Treatment received was repeat mammo and biopsy of lung nodule. The patient was recovering for all the events while Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear) was recovered. No follow-up attempts are possible. No further information is expected.

Shingles on face; This is a spontaneous report received from a contactable consumer, for patient. A 79-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on left arm on16Feb2021 at 15:30 (at the age of 79-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient took several prescriptions but did not had the list as concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on left arm on 26Jan2021 at 13:30 as a single dose for COVID-19 immunisation. It was unknown whether the patient had any allergies to food, medications or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Mar2021 at 22:00 the patient experienced shingles on face unsure if at all connected to vaccination. The patient did received treatment for the reported events and the medication was unknown. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit. The clinical outcome of the event shingles on face was resolving at the time of this report. Information about lot number cannot be obtained. No further information is expected.

Hive like rash on thigh and forehead; Very itchy scalp with bumps on head; Very itchy scalp with bumps on head; This is a spontaneous report from a contactable consumer (patient). A 79-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration, administered in left arm on 05Feb2021 at 14:00 hours as dose 2, single (at the age of 79-years-old) for COVID-19 immunisation. (Lot unknown reason: Not available/provided to reporter at the time of report completion). Medical history included allergies to sulpha from an unknown date and unknown if ongoing. Patient had no other vaccine in four weeks. Patient had no COVID-19 prior to vaccination. The patient's concomitant medications were not reported. Patient had earlier received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration, administered in left arm on 15Jan2021 at 13:00 hours as dose 1, single (at the age of 79-years-old) for COVID-19 immunisation. On 07Feb2021 at 08:00 hours, patient had very itchy scalp with bumps on head and had hive like rash on thigh and forehead. Patient had doctor or other healthcare professional office/clinic visit for all the events. Patient had not been tested for COVID-19, post vaccination. It was unknown if patient received treatment for both the events. The outcome of both the events was unknown. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via unspecified route of administration in arm left on 06Mar2021at 11:00 (at the age of 79-year-old) as single dose for COVID-19 immunization. Medical history of the patient included high blood pressure, sinus issues. Family Medical History included that her daughter has had reaction to medications, she had flu vaccine and she ended up in the emergency department, she had trouble breathing. Concomitant medications included atenolol started a long time ago taken for high blood pressure. Patient previously used clindamycin as in her age she occasionally breaks. Patient previously received flu vaccine in 2009 for immunization and had a reaction. She had the Flu vaccine for many years and the one she had trouble with was a vaccine without preservatives. On 06Mar2021, seven hours after receiving first dose of vaccination, in the evening patient noticed that her mouth started to burn, accidentally pinched her arm and the pain was more than expected and it left a bruise. On 12Mar2021, patient experienced sinus issues. On 20Mar2021, patient experienced that her legs were heavy and felt like they were weighted, which made it difficult for her to walk. On 22Mar2021, patient experienced burning pain on her lower lips, specifically in the space between the lip and the teeth. There was also burning pain in the face, in the arm and her neck-chest area, which caused great mental distress, a huge emotional toll, specifically being upset and devastated, lack of sleep, and weight lost due to lost of appetite with 5 pounds being lost within 2 weeks of these side effects. On an unspecified date in 2021, patient experienced hypersensitivity reaction. Patient stated that when she was changing her outfit she accidentally pinched her arm and the pain was more than expected and it left a bruise. About 7 hours after, she noticed that her mouth started to burn. She mentioned that she also had pineapple that day and was not sure if it was caused by the vaccine. On the 09Mar2021, she consulted a nurse practitioner who said that the burning may have been caused by the Pineapple. On 10Mar2021, she consulted her allergologist and got tested for a pineapple allergy. The results came in on 15Mar2021 and they came back negative for the allergy, but her allergologist mentioned that pineapple can still irritate the mouth. On 18Mar2021, she consulted with her Primary in which she was given magic mouthwash that made it worse. She was made to continue her benadryl and aspirin spray. On 20Mar2021, that Saturday night, as she was walking, she felt that her legs were heavy and felt like they were weighted, which made it difficult for her to walk. It lasted for about 20-30 minutes before subsiding. Last Monday, 22Mar2021 she really started to notice the burning pain on her lower lips, specifically in the space between the lip and the teeth. There was also burning pain in the face, in the arm and her neck-chest area. She described it as not constant but comes and goes. On 25Mar2021, she consulted with her primary again in which she was recommended not to get the 2nd dose of the vaccine and her side effects lean to a more neurologic cause. The doctor mentioned that the vaccine was still too new. These side effects has caused great mental distress, a huge emotional toll, specifically being upset and devastated, lack of sleep, and weight lost due to lost of appetite with 5 pounds being lost within 2 weeks of these side effects. She said that has not been fun. it has been horrible, and she would choose dying over this burning sensation in the mouth. Patient visited physician Office, 3 times and allergist did it virtually. Reportedly, after eating dinner she was eating pineapple from a can. She had the can and tried it. She had not had pineapple in a long time. While sitting in her recliner, she experienced her mouth burning. She added that began about an hour and a half after eating the pineapple and it has lasted for approximately 2 weeks. It was not constant all the time. She did not know at the time if the burning in the mouth was related to the pineapple. Caller added they thought it was the pineapple causing this. Last Sunday, the caller indicated that it was leaving and going away. Caller saw her new primary medical doctor on 09Mar2021. The Nurse Practitioner said it was probably the pineapple, She started her on Benadryl. Manufacturer was unknown to caller. Caller took 2 tablets on 09Mar2021 and stopped taking it on 10Mar2021. She restarted taking the Benadryl on about 14Mar2021. Caller stated she was primarily calling and asking because on Monday, 22Mar2021 she started having burning in her face and had burning in her arm. Caller reported the burning in her arm was not from the vaccine and she thought it was caused by her blood pressure cuff. Caller took her own blood pressure. Burning was better today, she still had burning in her arm. She took Zyrtec as instructed by her physician twice a day. She took a half tablet on 10Mar2021 through 13Mar2021. She was taking half a tablet in the morning and a half tablet at bedtime. Caller added that the Zyrtec made her feel unsteady and it made her sleepy. She did not tolerate it. Dose was 10mg. She has recovered completely from unsteady and being sleepy with Zyrtec. Caller took Tylenol because she was having sinus issues. She did not have the manufacturer, she took it on 12 and 20, two times. Its 325mg, by mouth, the regular strength. Caller saw an allergist on 10Mar2021 who tested her for pineapple allergy. The Allergist called on 15Mar2021 and reported she was not allergic to pineapple. Allergy was also tested for egg white, milk, wheat, corn, peanut, soybean, potato, yeast, and tomato. All resulted as negative. Benadryl: took 2 times in 09Mar2021. Caller restarted Benadryl and took it on 14Mar2021-17Mar2021. These days she only took it in the evening. She took 25 mg at night. Then she took Flonase, twice, on the 17th and 18th. Its over the counter. Lot number: TE8G, caller doesnt have box to provide UPC, stated there was another number of 0140592, expiry Mar2021. Dose was 27.5mcg per spray, spray into each nostril. When providing strength, states writing was so small for her to see. Gets a magnifying glass to confirm strength, states it's with her age. The doctor also suggested for the caller to try Afrin spray on 18Mar2021. Caller started it on 20Mar2021 and used it only once. She didnt like it. Caller said at her age she occasionally breaks out and uses Clindamycin for that. Dermatologist has her using Clindamycin 1 per cent pledgets. Applied twice to face once daily, She stopped 20Mar2021. Given Magic Mouthwash, which was in a pharmacy bottle, she took it once on 18Mar2021, but stopped. It was 5-10ml swish and spit. It made things worse and did not improve it. The doctor forgot to give her a measuring cup, and caller thought she told her a teaspoon. Caller added she tried using a warm cloth on her sinus area and her skin felt like a sunburn. The cloth left a red area around her cheek. Then this Sunday, after using the pledgets, went for a walk, next day noticed her face was really burned, not just face, her neck, arms, but she was not exposed, but had a burning pain, and she still continued to have it. She asked the dermatologist if this could be caused from the Clindamycin. The dermatologist told her no. She took a walk on Saturday and did not know if she was dehydrated. She felt like there were weights on her feet as she walked. It lasted 30 minutes. The burning in mouth started 7 hours after the first dose and it had improved. Therapeutic measures taken in response to the events included Benadryl, Zyrtec, Tylenol, Flonase, Afrin spray, clindamycin, magic mouthwash. Outcome of the events "mouth started to burn/burning in mouth" and "sinus issues" were ongoing-not recovered and for all other events were unknown at the time of report. Information on Lot/Batch number has been requested.

felt sick/sick as a dog; feeling nauseous; threw up like crazy; funny feeling around her head/Feeling really funny; face usually gets red when her blood pressure is high and it she is not red at this time; vertigo; blood pressure/ up to 210/110 mmHg; not walking well; funny feeling around her head/Feeling really funny; felt chills/Chills; Felt yucky; her balance was not quite right; felt the really funny feeling going up her throat; Her heart rate has been wanting to be a little higher than usual; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 79-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 30Jan2021(at the age of 79-years-old) (Batch/Lot Number: EL1283) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. Family medical history relevant to AE(s) was none and she is getting close to obesity if she keeps eating like this. The patient previously took first dose of bnt162b2 on 11Jan2021, (Lot Number: EK9231, Expiry Date: Unknown, this is not on the CDC vaccine record card) via Injection administered in Arm Left for covid-19 immunisation and experienced Left arm was real sore after first dose injection. The historical vaccine included shingles vaccine. The patient experienced blood pressure/ up to 210/110 mmHg on 20Feb2021 felt chills/chills on 31Jan2021, felt yucky on 31Jan2021, not walking well on 20Feb2021 , felt sick/sick as a dog on 20Feb2021, feeling nauseous on 20Feb2021, threw up like crazy on 20Feb2021, funny feeling around her head/feeling really funny on 20Feb2021, face usually gets red when her blood pressure is high and it she is not red at this time on 20Feb2021, vertigo on 20Feb2021, felt the really funny feeling going up her throat on an unspecified date in 2021, her heart rate has been wanting to be a little higher than usual on an unspecified date in 2021 and her balance was not quite right on an unspecified date in 2021. The patient underwent lab tests and procedures which included blood pressure measurement: 220/110 mmHg (normal value: 120/80) on 20Feb2021, computerised tomogram: doctor mentioned 3 little places on 20Feb2021, electrocardiogram: unknown results on 20Feb2021, heart rate: little higher than usual on an unspecified date in 2021, laboratory test: unknown results on 20Feb2021. Patient received both dose of the Pfizer covid vaccine on 11Jan2021 and 30Jan2021. On the next day after the 2nd dose, she felt chills. On 20Feb2021, she started not walking well, thought she would fall. All of a sudden, she felt sick and threw up like crazy while she was visiting her daughter for the day. The firefighters came to take her blood pressure and it was up to 210/110 mmHg. They advised her to go to the ER. After several hours, she was given blood pressure and nausea pills. They mentioned vertigo. She says it got okay. However, 2 weeks ago, she started to have a funny feeling around her head. Not dizzy but her face usually gets red when her blood pressure high and she was not red at that time. It was again reported that the day after she was administered the second dose of Pfizer-BioNTech COVID-19 Vaccine she had chills and felt yucky that day. She also reported feeling really funny since 20Feb2021. She was asked for further information on events related to Pfizer-BioNTech COVID-19 Vaccine. She was at her daughter and noticed her balance was not quite right. She started feeling really funny so just lay down there for a little bit. When she did get up after about 15 minutes she started feeling nauseous. She got to the bathroom really fast and threw up like crazy. She did not have her blood pressure cuff with her so her daughter called the fire department and took her down there real fast. At the fire station they took her blood pressure which was 210/110 mmHg, so they suggested she head to the emergency room so she did. She was under observation in the emergency room, but not admitted to the hospital. The doctor mentioned vertigo somewhere along the way before she left the emergency room. She just kind of brushed the vertigo off until she was reading about that the Pfizer-BioNTech COVID-19 Vaccine can cause vertigo. She guesses vertigo was what caused these events because she had been sick as a dog. When they got her on the bed and rolled her back she felt like she was going 90 miles per hour and by the time they got her back on the bed she was throwing up again-but this time and the initial onset of throwing up was the only times she threw up. They gave her something after probably 5-6 hours, blood pressure medicine and nausea medicine and she got ok and left there. Her heart rate has been wanting to be a little higher than usual. About 2 weeks ago she was just sitting on the couch and noticed especially when she would turn her head she still feels really funny; not dizzy, dizzy; she was walking ok; but the really funny feeling keeps hitting her continuously. During call when she sat back down she felt the really funny feeling going up her throat. It was just the weirdest thing, she wishes she had a word to really explain what the really funny feeling was but she does not. She has not checked her blood pressure for a while because she has been holding for a while for this department, so her blood pressure could be up a little bit, but she stated event was worse right now than it has been. Regarding testing/investigations while in the emergency room they did a CT head scan, lab tests, and an EKG. CT head scan results, the doctor mentioned 3 little places but when she talked to her doctor he said that was really just nothing to worry about with age; he said they will check it in 6 months and make sure areas are not growing. Caller has no further information to provide regarding lab tests or EKG results, they did not mention anything. Therapeutic measures were taken as a result of blood pressure/ up to 210/110 mmHg and feeling nauseous. The outcome of the events, felt chills/Chills , Felt yucky, her balance was not quite right, felt sick/sick as a dog, threw up like crazy, face usually gets red when her blood pressure is high and it she is not red at this time, felt the really funny feeling going up her throat, Her heart rate has been wanting to be a little higher than usual was reported as unknown, not walking well, feeling nauseous and vertigo was reported as recovering, funny feeling around her head/Feeling really funny and blood pressure/ up to 210/110 mmHg was reported as not resolved. No follow-up attempts are possible. No further information is expected.

Mouth around lips and cheek, followed by palette red sores,followed by swollen face,eyes blistering around eyes,burning itchy peeling rash neck,chest,around ears,burning itchy rash fingers to shoulder. On going progressive to present date. Prednisone finally prescribed at Hospital emergency. 40 mg. Per day for 5 days. Dr. is lowering the dosage. The first three weeks are prescribed 40 then 20 on going to 20 and an appointment July 22 to decide on the dosage to continue. I have photos documenting every horrible symptom. I was advised to do that.

she can't lift anything/Patient states she couldn't even roll over in bed, she just laid there like she was dead; muscle and body pain; body pain/ in a lot of pain; shortness of breath; headaches; lightheadedness; weakness; tiredness; chills; joint pain; nausea/Really Bad Nausea; it feels like her throat and neck are swelling and tight; it feels like her throat and neck are swelling and tight; it feels like her throat and neck are swelling and tight; weird bumps on her arms that were itchy but now are not; sore throat; she feels like her throat and neck is swelling and tight; weird bumps on her arms that were itchy but now are not/weird bumps on her arm; bone pain; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EW0171) via an unspecified route of administration, administered in Arm Left on 09Jun2021 (79-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included ongoing she is disabled and has been disabled for 27 years. Patient states she lost 14 pounds in the last 3-4 weeks, but that was before the shot. The concomitant medications were unspecified. Historical vaccine included flu shot When she gets the flu shot, she can get symptoms for about a week. 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 prior vaccination within 4 weeks. The reporter reported that, she received her first dose of the Pfizer Covid-19 vaccine on 09Jun2021, and then on 10Jun2021 she experienced Muscle and Body Pain, bone pain, sore throat, shortness of breath, headaches, light headedness and dizziness Really Dizzy; didn't know if she was walking forwards or backwards, Weakness; she can't lift anything. Patient states she has to have 3 sips of coffee in a cup and she still needs 2 hands to hold it; couldn't hold a pencil, tiredness, chills, joint pain and in a lot of pain, and Really Bad Nausea. The reporter stated that when the patient lays down it feels like her throat and neck are swelling and tight, and she also has weird bumps on her arm, the itching is gone but she can still feel the bumps. she couldn't even roll over in bed, she just laid there like she was dead. The reporter stated the patient is not getting the second dose and not going to the hospital. The reporter asked how long do these symptoms normally last, it's already been two weeks. The reporter asked, "If she can't take the second shot, can the doctor give her a clearance for that, Some places are forcing people to take this." Patient is in the background on speakerphone and states she is not going to the hospital, so forget that. The reporter stated the patient also has weird bumps on her arm, the itching is gone but she can still feel the bumps. The reporter stated that the side effects started on 10Jun2021. Patient states the bone pain lasted a week and a half and then every day something new came, they were kind of sporadic. Patient stated that she has the bumps on her arm, and everything except vomiting, if vomits she is in trouble. Patient states her bones are better some, but the weakness is there, she can't lift anything. Patient states she has to have 3 sips of coffee in a cup and she still needs 2 hands to hold it and she still gets dizzy. The reporter stated there are so many different side effects that they are unsure of when each one started and stopped, but most of the side effects are ongoing. Patient stated there is no way anyone will get her to go to the hospital but she just wanted to know how much longer is this going to go on. Patient stated last night she didn't know if she was walking forwards or backwards and she was so weak she couldn't pick up a pencil. Patient stated in the morning she thought she is still alive, she couldn't believe it. Patient stated she will not have the second shot, she cannot. Patient states she can't go through that again, she would rather die. Patient stated she couldn't even roll over in bed, she just laid there like she was dead. Patient states she has had a hard life but never like this. Patient stated she takes a lot of medications but she has been taking them for years and there are no medications or medical conditions that she feels are relevant. No treatment received for events. The outcome of the event muscle and body pain, body pain/ in a lot of pain, weird bumps on her arms that were itchy but now are not, bone pain were resolving and events were not resolved. Information about lot/batch number was provided. Additional information has been requested.

rash around the injection site and some on the chest, on both of my arms on my neck my face and sides on my right leg; rash came on both of my arms on my neck my face and it was peeling on the face; Within a half an hour swelled a little bit and then went down.; rash around the injection site and some on the chest that went away; the swelling on the face also; a lot of itching; Really Disturbed quality of sleep.; rash came on both of my arms on my neck my face and it was peeling on the face; This is a spontaneous report received from a contactable consumer (Patient). A 79-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 23Feb2021 10:00 (at the age of 79-year-old) as dose 2, single for covid-19 immunisation. Medical history included allergy to penicillin. Concomitant medication included LOSARTAN, METOPROLOL, DILTIAZEM HCL, MAGNESIUM P. AMINOBENZOATE. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient historic vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9262) via an unspecified route of administration, administered in Arm Left on 28Jan2021 10:15 AM as dose 1, single for covid-19 immunisation. On 04Mar2021, within a half an hour swelled a little bit and then went down. After second shot in about two days rash around the injection site and some on the chest that went away but then rash came on both of her arms on her neck her face and it was peeling on the face the swelling on the face also. Then the rash was on her chest on her sides on my right leg. It had continued since the 1st of March. She did have to go to Urgent Care twice and get medication. She was not able to get into her doctors office She was just now going to be able to go on July 7th. The medication helped temporarily. She was going to do a natural bowel cleanse and then a liver cleanse and then a kidney cleanse to try to get this eliminated. She reported a lot of itching. Really Disturbed quality of sleep. Had gone on for so many months she was tired of it. But she reported, it was better than getting covid and being in hospital with heart or lung problems. Events were reported as serious by the reporter. Patient did not receive any treatment due to adverse events. On an unspecified date in 2021 the events swelled a little bit and rash around the injection site and some on the chest was recovered and other events was not recovered.

This is a spontaneous report from a contactable consumer or other non hcp (patient). A 79-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE; Solution for injection, Batch/Lot Number: EN6198; Expiration Date: 30Jun2021) via an un-specified route of administration, administered in arm left on 28Feb2021 10:45 in the morning (at the age of 79-year-old) at dose 2, single for covid-19 immunisation. Medical history included dry eye (Exfoliation of eye, like a glaucoma. Had for 5-6 years), eczema (Had it as a child when she was kindergarten or first year, she outgrew it or was taken to the doctor), thyroiditis. Patient did not have history of all previous immunization with the Pfizer vaccine considered as suspect. Prior Vaccinations (within 4 weeks) was none. Adverse event following prior vaccinations was none. Family Medical History Relevant to adverse event was none. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) at 0.025 mg, 1x/day orally taken for thyroiditis in the morning by mouth (ongoing) (Started years ago); fish oil (OMEGA 3 FISH OILS) at 1000 mg, 1x/day, 1 a day in the morning, 650 epa/450 dha, 1000mg by mouth (ongoing) (Has been taking for 4-5 years); biotin (BIOTIN) at 5000 ug, 5000 mcg by mouth orally (ongoing) (Taking it for 4 months), dietary supplement (over the counter digestive one a day by mouth). Patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in left upper arm on 07Feb2021 (at the age of 79-year-old) at dose 1, single for covid-19 immunisation. On 28Feb2021 the patient experienced red spot with itching / red 4 inch from top to bottom, 1 and 3/4 redness across the entire area, red spot with itching / itchy experience, border on the bottom that looks like a bruise on left upper arm where i had the shot. Patient got a reaction in that patient experiencing a red spot with itching, like poison ivy, an itchy experience. Patient reported a red 4 inch from top to bottom, 1 and 3/4 redness across the entire area with a border on the bottom that looks like a bruise on left upper arm where patient had the shot. And asks, Is this normal how long does it last. The reporter is calling about the Pfizer covid vaccine shot number 2. The reporter received the second shot of the vaccine on 28Feb2021 10:45 in the morning. Everything was fine but she now has a red spot which is 4 inches from top to the bottom and an inch and 3/4 across. The instructions said that this would be a side effect. The red spot is itching, it feels like poison ivy, bouts of itching, there is a ribbon of bruising about an eighth of inch at the red spot. The reporter wants to know how long it will last and if its normal. Could it be from a needle with bacteria, or a reaction to the band aid. Event: The red spot remained the same, except the bouts of itching, and the top of it got a little redder. First dose: Received 07Feb2021, Lot EN6201, expiration date 30Jun2021. Received in left upper arm. Second dose: Received 28Feb2021, Lot EN6198, expiration 30Jun2021. Received on the left upper arm. The reporter mentions that she had nothing form the first shot and didn't know if it was common for something to happen after the second dose. The reporter asks why she didn't have the same reaction to the first shot. Adverse event did not require a visit to emergency room, physicians office. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Pt. states that after receiving the 2nd dose of Phizer 03/30/2021, started experiencing symptoms 04/12/2021 liver enzymes have gone up along with blood pressure reading. Rash appearing all around the thighs and legs with swelling, continuing to appear throughout the body. 04/13/2021 Primary visit, 06/14/021 Primary visit with Prednisone prescribed, and 07/20/2021 Primary continuing the previous prescription.

freezing with chills, and turned up the heat.; node on my arm; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; freezing with chills; freezing with chills; Nausea; slight headache; This is a spontaneous report from a contactable consumer(Patient). A 79-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 29Mar2021 12:30 (at the age of 79 years) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported), first dose via an unspecified route of administration, administered on 01Mar2021 as single for COVID-19 immunisation. Patient states she had the second shot yesterday and adds she didn't have any side effects from the first one. After the second one, by 20: 00PM she had nausea for about an hours and a slight headache that went away by the time she went to bed. Then early the next morning she was freezing with chills, and turned up the heat. Adds she didn't have all that with the first one. Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it. She is asking is all this a normal side effect. Mentions she took her temperature and she doesn't have a fever. Patient Clarifies she received the first dose of the Pfizer COVID 19 vaccine on 01Mar2021 in the afternoon in the left arm and the second dose on 29Mar2021 at 12: 30PM in the left arm. Patient further stated that "I got a node on my arm and it has fluid in it and I didn't have that before, so I'm concerned about it." The outcome of the events Nausea, slight headache was recovered on 29Mar2021 while the freezing with chills was recovered on 30Mar2021. While the outcome of the rest of the events were unknown. No follow-up attempts are needed. No further information is expected.

she started to get very sick, which continued to worsen until nowwhen she feels like she is improving; had stomach and abdominal pains; had stomach and abdominal pains/stomach is still very sensitive; loose stool; she was very tired; Pain or little discomfort in the arm she received the injection; Pain or little discomfort in the arm she received the injection; This is a spontaneous report from a contactable consumer (Patient). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, EH9896), via an unspecified route of administration to very top of right arm on 22Dec2020 at single dose for covid-19 immunization. It was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included glaucoma she had drops to take for, mostly she just has problem with her joints and her back with her age. She did not have any diseases or anything; she was not diabetic, nothing like that. There were no concomitant medications. She was administered her first dose of COVID-19 Vaccine on 22Dec2020. She reported that the pain or little discomfort she had in the arm she received the injection in disappeared by 25Dec2020. But on 24Dec2020 she started to get very sick, which continued to worsen until now when she felt like she was improving. She did not know if these events could have something to do with the COVID-19 Vaccine. Pain or little discomfort in the arm she received the injection: Right arm. Everyone warned her that the site would hurt, so she was really glad when it totally went away on 25Dec2020 and thought that it was over; any issues from the injection. Very sick: this event started to get bad on 24Dec2020, she was very tired and not very hungry, she had stomach and abdominal pains and loose stool; 25Dec2020 those symptoms were worse. It was Christmas so she cooked and thought at first maybe she got carried away baking pies; because that evening she started to have pain and did not each much. 26Dec2020 it was worse; she said she was going to work on 27Dec2020; it was terrible because she was stuck for 12 hours trying to work while very sick. She called off of work 28Dec2020 and 29Dec2020. Since then she has stayed home and still has pain but she took her ranitidine delayed release 100mg twice daily as needed for stomach pain as given to her by her doctor, and is now down to just once daily. She did not know what she would have done without the ranitidine. She did not have any more abdominal pain, but her stomach was still very sensitive. She was tired but thought she was going to be ok. She was scared to get the second scheduled dose of COVID-19 Vaccine because she thought the side effects will be more severe with the booster shot. She just needed to rest and stay home which she has been doing. She has not had any fever. She has not notified her family doctor of these events. There was nothing she did on Christmas that she could think of other than she drank a glass of champagne because she did not know her stomach was going to be so bad. The outcome of the events Pain or little discomfort in the arm she received the injection was recovered on 25Dec2020, the outcome of event sickness was recovering, the outcome of the event Abdominal pain was recovered on an unknown date in Dec2020, the outcome of event stomach pain was not recovered, the outcome of the other events was unknown.

I am having rash development on both upper front thighs, chest stomach and back. Itch a little but little red spots are visible. Never have had an allergy or allergic reaction all my life to anything. The only thing different done since new year is the Covid-19 vaccine (Pfizer-BioNTech) was the vaccine. It was my first dose and questioning whether to do 2nd vaccination. If I am allergic to the synthetic vaccine...I am uncertain about taking the 2nd dose which could catastrophically cause more problems as in constriction of breathing, rashes , death etc. I am due for 2nd dose on 01/28/21. I would appreciate input as to whether i should receive 2nd dose; and i wanted to report my adverse affect which i am still having. Thank you.

She reported her injection site became red, hot to touch, and swollen, she also said she felt body aches all over and had a temperature of 99.6 for several days after the vaccine. Today is the first day she didn't have a temperature and she feels good.

She got bruise on the injection site about the size of a half dollar; Headache; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 07Jan2021 at single dose for COVID-19 immunisation. About lot, the reporter doesn't know if it is an L or a C, 3249, and thinks it is a C. Age at vaccination was 80-years-old. Medical history included blood pressure high. Concomitant medications included lisinopril for blood pressure high plus an unspecified long list. When she got the shot, she got bruise on the injection site about the size of a half dollar. She has headache too, first two days. Onset of headache was reported as 8th or 9th day after vaccination (Jan2021). The patient is supposed to go back on the 29th. The patient was still experiencing headache, slightly but not as bad, while outcome of bruise on the injection site was unknown. Information on the lot/batch number has been requested.

Received Vaccine at about 9 AM 1/20/21. At 4 pm on 1/20/21 developed a raised rash that itched on upper body front, back and arms. Face not involved. Spoke with Dr. and ordered to take Benadryl and call PCP. I/21/21 Reported Benadryl was taken at 5 pm on 1/20/21and symptoms were relieved but returned at 9 pm 1/20/21. Took 2 more Benadryl. Reports no rash 1/21/20 but weak and tired.

Within one hour- flushing, headache, and swelling and sore lymph node- right side. Over nite and for 3 days fever of 100.2. Tired, skin hurt and sore throat- swollen lymph node lasted for 4 days.

waves of heat in hands, arms, chest up into head . 3x per day. feel tired and naesous afterwards. still happening after one week

welts all over (her) body; Itching; Red welts all over body; This is a spontaneous report from a contactable consumer. An 80-year-old female consumer BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) on 13Jan2021 at 12:00 p:m at single dose for COVID-19 immunization. Relevant medical history included penicillin and bee stings allergies. Concomitant medications were not reported. On 13Jan2021, about 3 hours after vaccine patient experienced red welts were all over her body, face, arms, and under breasts. She was itching all over. Patient took three allergy pills and the reaction subsided. Patient didn't provide product name of allergy pills. Patient informed she had a reaction before to Penicillin and clarified her reaction with Penicillin was red welts and itching, but her tongue didn't get sick on an unspecified date. Patient was supposed to go back and get second COVID-19 Vaccine, but she was not going to take it unless there is a COVID-19 Vaccine without Penicillin in it (as reported). Provided date on patient card of 03Feb2021. At the time of the reporting event outcome was unknown.

Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Rash (other than injection site)-Mild

high itching over her whole body, itching all over even her head and hair, up and down her spine, everything; This is a spontaneous report from a contactable consumer (patient's husband). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, on 13Jan2021, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient experienced high itching over her whole body, itching all over even her head and hair, up and down her spine, everything in Jan2021. Outcome of the event was unknown. Information about Lot/Batch has been requested.

Client presented with rash on right upper arm and chest area. Clietn was on the 30 min observation when the rash appeared after receiving the Covid-19 vaccine. Client was assessed by EMT at 9:30 am. HR 74, O2 99%. Client was stable and cleared to leave at 10:00 am.

Resident s/p Covid 19 Vaccination on 01/19/21.. Resident stated she got 3 small raised areas (2.0L X 2.0W cm) (1.5L X 1.5W cm) (1.0L X 1.0W cm) on Right lower leg and one small raised area (1.0L X 1.0W cm) on left lower leg. She noticed them the next day after the vaccination (1/20/21). Besides, She also noted raised, red, area on the injection site on her right upper arm on 01/27/21. She also stated that she had bad reaction, dry heaving after she had her Flu and Pneumonia vaccine last year. Denied shortness of breath, difficulty breathing, fever, tender, pain upon touch but very itchy and asking any medication. Wellness Nurse explained resident to keep the area clean and dry, no scratching and to let us know if there is increased redness/ area or skin breakdown.

Sore arm at injection site. Know this is normal, but on 3rd day it got considerably worse and this is now a week later, and arm is much better, but for 2-3 days it was painful. Scheduled to back for 2nd injection on Feb. 13. Is this going to be a problem? Was told by oncologist 2 1/2 years ago not to use right arm for anything. Do not want to miss 2nd injection. OK to have injection again in the left arm?

Had large dark bruise day after injection and pain for 3 days. Much swelling of upper arm and upper area of shoulder and arm pit area started 6 days after injection and continued until doctor told me to put ice packs for 20 minutes 4x day on area. Today is 2/02 and arm =still swollen but not as swollen as it was before icing. Tried to keep arm elevated when sitting.

I began with mild arm ache 24 hours after vaccination, 72 hours later the site became swollen, red and itchy. Overall I feel fatigued and lost my appetite. In addition when I had CoVID in September I experienced difficulty falling or staying asleep. I experienced that last night again. I am very tired but unable to fall asleep.

Site: Bruising at Injection Site-Severe, Systemic: Other- Brusing down patients hand and wrist-Medium

Started not feeling right- her stomach was bothering her; diarrhea; Her face turned red; Face and chest felt like they were on fire; Freezing and could not warm up; She was very crampy; nauseous; Left arm soreness; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3247) solution for injection intramuscular in the left arm on 19Jan2021 (at the age of 80-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. On 19Jan2021, the patient started not feeling right- her stomach was bothering her, diarrhea, her face turned red, face and chest felt like they were on fire then freezing and could not warm up, she was very crampy, nauseous and left arm soreness. The outcome of the events stomach discomfort, diarrhea, feeling hot, feeling cold, very crampy and nauseous was recovered on 19Jan2021. The outcome of the event face turned red was unknown. The outcome of the event left arm soreness was not recovered.

Developed a stiff neck after a week or so and thought nothing of it until now because it is not going away. Also , I developed an itchy pimply rash on my lower back that is troublesome and for which I am using benedryl. The asprin nor the aleve seem to help the neck. The itchy is driving me nuts--benedryl helps a little. SHOULD I GET MY SECOND DOSE WHICH IS DUE FEBRUARY 10?

gray spot on forehead; face felt hot and flushed; Face red; was tired and wiped out; Eyes were red bloodshot; face was burning and burned bright red/her face feeling sunburned/ face got really like the worst sunburn; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot: EL8982) intramuscular in right arm on 22Jan2021 at 13:00 at single dose for COVID-19 immunization. Medical history included Gastroparesis from 2016 and ongoing, ongoing Osteoarthritis (diagnosed about 10 to 20 years before), acid reflux (esophageal), blood pressure, osteoporosis, arthritis, anxiety, high cholesterol, stomach problems, allergies and pretty bad sinus problems/sinus trouble in the winter, leg cramps at night, allergic to all kind of bites. Patient previously took shingles vaccine as immunization and she had had a small reaction, she had a patch of shingles break out around her arm at the site of injection site. Concomitant medication included ongoing omeprazole for Gastroparesis, ongoing erythromycin, ongoing aluminum hydroxide/magnesium carbonate (GAVISCON) for acid reflux (esophageal), ongoing calcium for Osteoporosis, ongoing losartan for Blood pressure, ongoing acetaminophen for arthritis, ongoing spironolactone as diuretic, ongoing tramadol for Osteoarthritis, vitamin C [ascorbic acid] as general supplementation, ongoing alprazolam for Anxiety, ongoing doxazosin for high blood pressure, ongoing fenofibrate for High cholesterol, ongoing vitamin b complex (B-COMPLEX) as general supplementation, ongoing bisoprolol for high blood pressure, ongoing magnesium good for heart recommended by cardiologist, ongoing biotin for hair and nails, ongoing zinc as immunity booster, ongoing montelukast sodium for allergies and pretty bad sinus problems/sinus trouble in the winter, ongoing levocetirizine dihydrochloride (XYZAL) for allergies, ongoing cyclobenzaprine for leg cramps at night as muscle relaxer, ongoing macrogol 3350 (MIRALAX) as laxative and ongoing "CVS brand multivitamin at one tablet once a day oral as general supplementation" (as reported).The patient experienced face felt hot and flushed and face red on 24Jan2021; gray spot on forehead on 25Jan2021; was tired and wiped out, eyes were red bloodshot, face was burning and burned bright red face feeling sunburned in Jan2021.Events were described as follows: patient received the first dose of the vaccine on 22Jan2021 and she had a few mild symptoms. She did not feel really good for a day or two but it was nothing that alarmed her, she was tired and wiped out. She always took a shower since she had arthritis and it get gets her joints going. On 24Jan2021 after she got out of the shower, her face felt hot and it was red. She didn't think too much about it and it went away pretty soon. She did not connect it with the vaccine. On 25Jan2021 she took a little longer shower and the same thing happened, but it was 10 or 12 times worse in regards to her face feeling hot and was red. She was drying off and getting dressed and reported her face felt funny and it was really hot. When she looked at it was bright red like she had the worst sunburn, it felt like a sunburn. Her face was red and eyes were red bloodshot and it lasted about half an hour; her face got real flushed like a real bright sunburn and her face was burning and burned bright red. She started putting on cold wet wash cloths to help cool her face down and when it the wash cloths got warm, she would wet it again to cool her face down some more. She was alarmed but about 30 minutes later it started lightening up a bit and pretty soon it was back to normal. Her face felt different in the afternoon, it was a little red. She worked out in yard and last summer she got an insect bite on her forehead that turned gray, it was the size of silver dollar. After the hot flush thing this morning, that gray spot came back. Her doctor said it might take a while for it to go away. Her face felt warm like it has been sunburned. Her throat was dry since she has been waiting on the phone for an hour. Her face feeling sunburned/hot was about 95% gone, barely there. Her face getting red started on 24Jan2021 morning and it was almost gone. Treatment included ponds face cream and it was very soothing. Patient just wanted to know what to do about this flushing of her face and if it was dangerous what she can do. She would like to know if she should be worried about this, it only happened when she took a shower. She was asking if there was anything she can do before she can get the second injection, so it does not happen again or what to do if it does happen again. Final outcome of tired and wiped out, eyes were red bloodshot and face was burning and burned bright red/her face feeling sunburned/ face got really like the worst sunburn was unknown; outcome of the other events was not recovered.

After 2 weeks of received 1st dose COVID19 vaccine the patient presented to the hospital with a chief complaint of slurred speech, diffuse rash and headache. Found to have diffuse petechiae. Platelet count was < 2. CT head was significant for bifrontal and parafalcine subdural hematoma and scattered subarachnoid hemorrhage. Assessed by the hematology team who stated presentation and lab work was consistent with immune thrombocytopenia. Patient now admitted to the ICU undergoing platelet transfusions and treatment with steroids and IVIG

Pain in upper left arm; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number EL1284) , via an unspecified route of administration on 18Jan2021 14:00 at single dose on left arm for covid-19 immunisation. There were no medical history and concomitant medications. The patient experienced pain in upper left arm on 24Jan2021 16:00. She received her first injection as initially on 18Jan2021 14:00. It has been about ten days now and she was now feeling pain in her upper left arm. Yesterday and today the pain was intense. She had felt good all week. She has even taken two Tylenol and it has not calmed down the intense pain. Therapeutic measures were taken as a result of pain in upper left arm (pain in extremity). The outcome of the event was not recovered.

Patient was vaccinated at 1435 pm and immediately upon vaccination patient noted hives going up her left forearm. This was the same arm of the vaccination. 50mg of Benadryl was administered orally at 1440 pm per our policy and procedures and patient continued to be monitored for adverse signs and symptoms. At 1505 RN noticed flushed face and redness on neck. No shortness of breath was noted and speech was maintained. At 311 patient stated general feeling of racing heart. Vitals were taken. HR 80, BP 140/80, RR 14. EMT was notified and called with a 1526 Arrival. Patient was transferred to Healthcare and call back at 1629 letting us know patient was stable.

6 days post injection woke up with 2 inch circle of bright red rash around injection site. Minor itching. Lasted 6 days.

Rash on chest and some on legs, 4 hours after the vaccine was given to me. My PCP Recommended taking Benadryl, one every four hours, which I have done, and it is helping.

First shot no problems. Second day after second shot, fatigue, could not get warm, redness and heat at the injection site. Diminished appetite. Body aches. Third and fourth day after shot redness and itching at injection site

Patient is a 80-year-old female past medical history dementia, carotid artery stenosis, hypertension, GERD, anxiety/depression, etc. Patient presents to the emergency room with her husband secondary to muscle loss in the area where she received a Covid vaccine on 1/29/2021. Husband states that she had equal and normal symmetrical shoulders. On 29 January she did have her first Covid vaccine injection the left shoulder. Has been noticed that the muscle in the area started to reduce significantly almost where there is a hole/defect. Patient denies any pain or discomfort. There was no report of significant bruising over the area. No redness or fevers. Husband states that he is also noticed patient having bruising bilateral forearms intermittently over the past few weeks. No other complaint. No modifying features. * note physician note from ED visit says vaccinated on 1/29, but her appointment was on 1/28.

I am reporting that I was diagnosed with shingles after 2 wks of getting my 1st dose of Covid vaccine shot in my upper left arm. My arm starting hurting & a few days later, I broke out with tiny dark red spots inside a red swollen circle. Arm remained with a burning aching pain. My dermatologist said it was definately shingles & prescribed a 10 day treatment of antiviral medication. She didn't know if it was caused by the vaccine but should report this. The shingles are just below the shot area.

injection site inflamation redness around injection about the size of a quarter, itchy with raised bumps, tin taste in mouth, irrated tongue. severe tiredness. sore arm.

itching of the skin in the neck area. Lightheaded. Ambulated with staff to the medical area. Given water and Benadryl 50 mg po. Rested lying down for 15 minutes, felt much better and declined to receive further medical care. Husband with her and driving her home.

Blotchy rash on arms and legs started on morning of February 15. Went to doctor on Wednesday, February 17. He gave rx for Hydroxyzine. Symptom is still existing but not as bad. Also, had chills the next day after vaccination on Friday, February 12 but only lasted one day and is gone.

Asthma attack began about 20 minutes after injection, with throat tightening, slight mouth swelling sensation and immediate wheezing which grew progressively worse. I had my inhalers (Levalbuterol and Flovent) with me, used Levalbuterol at the direction of medical people who surrounded me after I reported wheezing. They gave me a Benadryl, then brought a wheel chair and sent me directly to the ER. I was there about 3 hours during which I had a heart monitor, a "breathing treatment" by a respiratory therapist, and DUONEB, famotidine (PEPCID), and (DELTASONE). I was given a 3 day Rx for 20 mg. of prednisone, and released. My lungs felt "twitchy" the next day and my voice was muted, but was well otherwise. The only "normal" side effect I had was some soreness at the injection site for a couple of days, with some light sensitivity there for a few weeks.

Severe rash over entire body appearing in the evening after the shot. Initial treatment with antihistamine had little effect. Eventually used triamcinolone cream and that helped to reduce the rash. Still persists 4 weeks later with lingering rash on legs.

injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever 99-101 degrees; medical history of myasthenia gravis was given Pfizer-Biontech-Covid-19 Vaccine; medical history of myasthenia gravis was given Pfizer-Biontech-Covid-19 Vaccine; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH-COVID-19 VACCINE; lot number: EL1289; expiration date: unknown) was 80-year-old at the time of vaccination via an unspecified route of administration right arm on 26Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included myasthenia gravis, bipolar disorder, chronic obstructive pulmonary disease (COPD), hypothyroidism, high cholesterol and allergies to ACE inhibitors. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), fluticasone propionate (ALLER FLO), cetirizine hydrochloride (ALLER TEC), aspirin [acetylsalicylic acid] (ASPIRIN), clonazepam and ipratropium bromide (IPRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took ciprofloxacin (CIPRO) but had allergies. The patient received the most recent COVID-19 vaccine in a hospital. On 28Jan2021 07:00 AM, the patient had injection site pain, tiredness, headache, muscle pain, chills, joint pain and fever 99-101 degrees. The patient who has a medical history of myasthenia gravis was given Pfizer-Biontech-Covid-19 Vaccine on 26Jan2021 with unknown outcome. The patient did not received treatment from the adverse events and the events was considered as non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of all the other events was not recovered.

large red circle that is swollen & irritating. Also a mark where neddle inserted.Put cool compress on & took tylenol

COVID arm and swelling to right jaw with extreme pain that lasted about 24 hours the week after the injection.

On the second day after i received the first dose of the Covid vaccine I started having tightness in my chest with a cough. On a scale of 1-10 the symtoms were 7-8 I also developed a rash on my arms as if I had been burned. I had to use an inhaler that I already had and I ussed Hydocortisone cream on the rash I saw the Nurse Practicioner on 2/10 2021 and was given Medrol 4mg tabs Today I am still coughing with slight tightness in my chest and the ras is resolving but scars linger.

Intense itching and redness in a 4 to 41/2 inch circle on upper left arm around injection site. Very warm to the touch. Used Benadryl, Tylenol for first two days. Also wet wash cloth on red area at frequent intervals. After 2 days redness began to disappear.

Feet felt stiff and bone in right leg felt strange; Feeling dizzy and faint like; tired; Sinuses started to drain; itching on the right shoulder (where she had the vaccine); Itching on right side of arm near elbow, middle part of stomach and neck; pain in the shoulder; This is a spontaneous report from a contactable consumer, the patient. AN 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6201, Expiry date: 30Jun2021) intramuscularly in the right arm on 11Feb2021 at 13:00 (at the age of 80-years-old) as a single dose for COVID-19 immunization. Medical history included highly sensitive and highly allergic to everything from food to medicine; had been through near death with allergies; allergic to penicillin, iodine and shellfish; high blood pressure, eye disorder (unspecified), allergies with her sinuses. Concomitant medications were not reported, but the patient took unspecified high blood pressure and eye medication. The patient previously took dextropropoxyphene hydrochloride (DARVON), ether and castor oil and experienced allergies; sulfamethoxazole and trimethoprim (BACTRIM) for severe acute sinusitis on Jan2021 (about a month ago). On 11Feb2021 at 13:20, the patient start feeling dizzy and faint like, and felt a little tired. She came home and went to bed and on 11Feb2021, had itching on the right shoulder (where she had the vaccine) and on the right side of the arm near the elbow, the middle part of the stomach and the neck (itching came and went) and later, her sinuses started to drain. On 12Feb2021, the patient's feet felt stiff and the bone in the right leg felt strange. On an unspecified date in Feb2021, the patient had pain in the shoulder. The patient queried if she can take aspirin for the pain in the shoulder and diphenhydramine (BENADRYL) if the itching comes back. The clinical outcome of pain in the shoulder was unknown, of "itching on right side of arm near elbow, middle part of stomach and neck", "feeling dizzy and faint like", tired, sinuses started to drain, "feet felt stiff and bone in right leg felt strange" and "itching on the right shoulder (where she had the vaccine)" was resolving.

Patient had her second COVID vaccine on 2/20/21. The next day she developed diffuse body aches. She went on to develop worsening dyspnea and fever to 103°F on February 23. She had a fever again on February 24. The patient also experienced a few episodes of vomiting and diarrhea but no abdominal pain and had pain of the legs, right greater than left. Blotchy red patches of the hands and arms developed. She therefore presented to the ER on 2/25/21. See full history below from infectious disease note on 3/1/21: Patient is an 80 year old female who has a past medical history notable for hypertension, dyslipidemia, and hypothyroidism. The patient was diagnosed with a high-grade lymphoma of the retroperitoneum in 2004 and completed 4 cycles of multi-chemotherapy (Cytoxan, Adriamycin, vincristine, methotrexate, and IT chemotherapy (Magrath-like regimen)). She completed 4 cycles with complete remission on PET scan. The biopsy of a left cervical lymph node in 2007 revealed follicular lymphoma and she completed radiation therapy to the neck with complete remission. A left axillary lymph node biopsy in 2016 revealed grade-3 follicular lymphoma with mixed follicular and diffuse histology. Chemotherapy was pursued. The biopsy of a pelvic lymph node in 2019 was consistent with G1-2 follicular lymphoma.  She completed radiation to the pelvis in May of 2019.  She developed progressive pelvic adenopathy in April of 2020 and received 5 cycles of chemotherapy. Subsequent CT showed improvement in the adenopathy.  Her course was complicated by pulmonary emboli (September 2020).  In November of 2020 she was started on maintenance Rituxan every 2 months.  She received the 2-dose Pfizer COVID vaccine series on 1/29/21 and 2/20/21. With the above background, the patient presented to the emergency room on February 25, 2021 with complaints of diffuse body aches, which had developed that day after receiving her second dose of COVID-19 (SARS-CoV-2) vaccine.  She went on to develop worsening dyspnea and fever to 103°F on February 23.  She had a fever again on February 24. The patient also experienced a few episodes of vomiting and diarrhea but no abdominal pain and had pain of the legs, right greater than left. Blotchy red patches of the hands and arms developed.  She called Oncology on February 20 and it was recommended that she go to the emergency room for evaluation.   She was afebrile on presentation to the emergency room.  She was tachycardic, however, with a pulse rate of 117 bpm.  She was breathing at 48 breaths per minute.  Blood pressure was 105/80 mmHg.  Oxygen saturation by pulse oximetry was 96%. Examination was notable for paraspinous muscle tenderness, tachypnea, mild respiratory distress, and a mildly distended abdomen.  Mild erythematous patches of the feet and forearm were noted, as well as evidence of edema of the right leg from the knee to the lower leg. The peripheral blood leukocyte count measured 0.8x10e3/µL.  ANC was 0.48x10e3/µL.  Platelets measured 96x10e3/µL.  Creatinine was 0.97 mg/dL.  AST was 86 and ALT 20 U/L. The lactic acid level of the venous blood was 3.6 mmol/L. The procalcitonin level of the blood measured 28.37 ng/mL. The C-reactive protein level was 313.7 mg/deciliter. The creatine kinase (CK) level was 4023 U/L.  LDH measured 314 U/L. Troponin was 3.22 ng/mL.  Urinalysis showed 6-10 wbc?s, 0-2 rbc?s/hpf, 3+ blood, negative nitrites, hyaline and granular casts as well as amorphus crystals. A chest radiograph showed possible, but not definite, mild atelectasis or infiltrate at the left lung base.  A radiograph of the right tibia/fibula showed circumferential soft tissue edema seen within the knee and upper to mid aspect of the lower leg.  EKG showed sinus tachycardia but no evidence of arrhythmia or ischemia. Cultures of specimens of the blood were obtained.  The patient was started empirically on vancomycin and cefepime and was admitted.   Faint erythema and ecchymosis of the right leg extending to the dorsal right foot and right wrist erythema were noted following the patient?s admission.  Her condition subsequently destabilized with increased respiratory rate, worsening pain, and hypotension, so she was transferred to the ICU. An abdominopelvic CT on February 25 revealed a small amount of free fluid in the abdomen around the liver, cholelithiasis with no evidence of acute cholecystitis or biliary dilatation, a nonobstructing 5-mm stone of the mid pole of the left kidney, coronary artery calcifications, mild infiltration of the fat in the inferior retroperitoneum and along the right common iliac region with small nodes in this region, similar compared with September 24, 2020, but improved compared with April 30, 2020, and consistent with response of lymphoma to chemotherapy; a myomatous uterus. A CT scan of the right lower extremity showed extensive edema about the subcutaneous tissues of the right lower leg and infiltration of the fat about the muscles of the right lower leg, likely representing cellulitis and fasciitis, and possible myositis. However, there was no air within the subcutaneous tissues or muscles to suggest necrotizing fasciitis and no evidence of abscess.     The patient?s antibiotic treatment was later changed to vancomycin, piperacillin-tazobactam and clindamycin. Cultures of specimens of the blood were later reported as being positive for methicillin-susceptible Staphylococcus aureus on 2/2 sets. Repeat blood cultures (February 26) were positive as well. Her antibiotics were modified to cefazolin monotherapy. Repeat blood cultures on Feb 27 and 28 were negative.   TTE completed 2/27/21 without obvious vegetation.   TODAY (3/1/21): Cultures negative 2/27 and 2/28. Remains on IVIG. Afebrile. She complaints of continued pain in the Right leg and swelling at that left arm. Exam GENERAL: NAD EYES: Sclera and conjunctiva clear NECK: no adenopathy LUNGS: Breath sounds normal and symmetric. No rales or wheezes. HEART: regular rhythm, no murmur appreciated ABDOMEN: Soft without mass, tenderness, organomegaly or hernia. EXTREMITIES: RLE with ecchymosis, slight overlying erythema and anterior blister: blistering more pronounced today. left foot with plantar erythema, some tenderness today. LUE fullness with some heat/tenderness SKIN: No other rashes or other abnormalities are noted. NEUROLOGICAL: alert, appropriate Assessment 1. MSSA septicemia with shock. Positive blood cultures 2/25 and 2/26 thus far. Negative since 2/27. 2. Multifocal cellulitis and interstitial infective myositis of LE- suspect related to above. CT scan was negative for apparent necrotizing infection. 3. Elevated CK due to above- improving 4. Recurrent lymphoma- has been on maintenance rituximab (11/2020). Immunocompromised state. 5. Low immunoglobulins- remains on IVIG 6. Positive urine cultures with Staph aureus- this is typically secondary seeding from bacteremia rather than primary staph uti. CT abd/pelvis negative for nidus of infection along GU track (no renal abscess for example) 7. LUE swelling/tenderness.   Plan 1. Cont Cefazolin without change: goal dosing 8gm/24hr 2. Following repeat blood cultures, negative thus far (tentative D0= 2/27/21) 3. Pending course, anticipate likely TEE--- > presently precluded due to thrombocytopenia 4. Will obtained LUE doppler for completeness given pain/swelling here. Down the line, may need to consider additional imaging (CT?) if concern for abscess, etc). 5. ID will follow along with you. Please call if any questions/concerns. Patient is still admitted, and is in the ICU.

A little lump developed on the front side of the arm on Monday, today hot and red but almost flat. Silver dollar size.

red blotches; felt sensation at her foot for that she could not walk; experienced chills; hands were shaking; right foot and ankle swelling; right foot and ankle swelling; pain; This is a spontaneous report from a contactable consumer (reporting for herself). An 80-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date: 31May2021), via an unspecified route of administration on her left arm on 30Jan2021 to 30Jan2021 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took phenytoin sodium (DILANTIN) and carbamazepine (TEGRETOL) and experienced allergy as her reaction to those were sometime between 2010 and 2012. On 30Jan2021 after three and a half hours, the patient felt sensation at her foot for that she could not walk, experienced chills, hands were shaking, had a swollen ankle and foot and pain. Around 5 o clock, the patient stated that it was like a strange sensation in her foot and she also got chills. By 7 o clock, she was in pain. The patient stated that she took two Tylenol. The patient stated that at around 9 o clock, she noticed that her ankle and foot were swollen with red blotches on it so she took two Benadryl and then slept until noon. The patient stated that Benadryl actually gave her some relief, although the pain didn't completely subside, but it subsided a little so that it was more tolerable. The patient stated that she had been debating if she should have gone to the emergency room (ER), but she didn't because she has a high pain tolerance. The outcome of the events was unknown.

Chills; Fever; aches and pains; no appetite; felt weak as a kitten; injection site got swollen; having pain where the injection occurred; she had felt like she was at death's door; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose on BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN6200) solution for injection, via an unspecified route of administration in right arm on 15Feb2021 at a single dose for Covid-19 immunization. Medical history included allergies, hip surgery, and foot surgery three times. Concomitant medications included unspecified medications. Patient reported she has been so sick. She got the shot on Monday 15Feb2021, and that same day she got so sick, it was horrible. Patient had chills, fever, aches and pains, and if someone named it, it was there. She stated that before Monday she was 183 pounds, didn't know if it has changed as she has not been on a scale, but she was sure it has because hasn't eaten since Monday, as she has had no appetite. Her appointment was at 07:45, and she went right when she got up, so she did not really have anything to eat on Monday. Patient stated that on Tuesday, she did not eat anything until the evening when she had one piece of pizza. Today, patient has only had a yogurt. Today was the first time she has gotten out of bed and even felt like getting dressed and putting her contacts in, since Monday. The last few days, patient stated that after getting up and going to the bathroom she would walk downstairs and felt weak as a kitten (15Jan2021). Patient stated that she was at least 80% better, because she had felt like she was at death's door (Feb2021), and she was not a wimp, it was just horrible. Patient mentioned that she was on a lot of medicine, probably 10, but this was the first time she was receiving this vaccine. She stated that she was still having pain where the injection occurred (Feb2021), like when her shirt touches it, she can tell it was there. But patient stated that she had the nicest nurse and the injection itself did not hurt, it was just later, and the injection site got swollen (Feb2021). Outcome of the event she had felt like she was at death's door, chills, fever, aches and pains, felt weak as a kitten was recovering; no appetite was not recovered; while the other events was unknown. No follow-up activities are needed. No further information is expected.

1st shot about 20 minuets later started felling flushed and temp fluctuated for about two hours. Then a day or two later started getting left arm rash then on to the right arm a few days later. Don't know if rash was caused by that. Went for 2nd shot today and rejected when I told them about fluctuation of temperatures at fist shot. How can I get second shot??

Pt presented back to clinic today with golf ball sized raised red area around injection site. There was a small dime-sized purple bruise where needle entered skin and the bruise was surrounded by reddened area. Pt states she had no other s/s. She states the redness appeared "a few days ago". It does not itch.

white count was low; Left arm got a red rash all the way up and down, my shoulder to mid way between my elbow and hand and some swelling; Left arm got a red rash all the way up and down, my shoulder to mid way between my elbow and hand and some swelling; my arm hurt a little bit; This is a spontaneous report from a contactable nurse (patient). An 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1284) on left arm, intramuscular on 02Feb2021 at single dose for COVID-19 immunization. Medical history included pancreatic cancer stage IV metastasized, blood pressure (abnormal) and chemo. Concomitant medication included pancreatin (CREON) for pancreatic enzymes. The patient previously received the first dose of BNT162B2 on 12Jan2021 for COVID-19 immunization. The patient had a side effect and it's so weird, she was a cancer patient she was in (city, state) and she had her first Covid vaccine on 12Jan2021 and she had her second one on 02Feb2021 and not a reaction until yesterday (06Feb2021) her left arm got a red rash, all the way up and down her shoulder to mid way between her elbow and hand and some swelling and she just wanted to make sure. She did look at the sheet and it does say you can get a rash, she has no temperature and she wanted to make sure that's a part of it all. When clarified if the retired registered nurse wanted to if it was the side effects from Covid vaccine, she stated, she guessed so because she got it on Tuesday and her arm hurt a little bit (Feb2021) but no rash showed up until yesterday which was Saturday. The patient had blood work done last Monday on 01Feb2021 with unknown results. The patient reported that she knows her white count was low (unspecified date) because they could give her chemo, so she actually has blood work on Monday 01Feb2021. Treatment was not received and patient stated, it just showed up yesterday and her nurse told her not to put anything on it. The outcome of the events was unknown.

Pt got the first vaccine on 3/1/21 and she developed a heart flutter on 3/4/21 and a rash on 3/5/21. The patient developed heart flutter at night on 3/4/21, which she thought was a heart attack. She called EMS and they checked her out and all her vitals were normal. She saw her MD on 3/5/21 who said it was not a heart attack and she was fine. He did not think the symptoms were related to the vaccination and he thought the heart flutter was stress related. The heart flutter went away on it's own. She also developed a red rash all over her body the evening of 3/5/21 that is still present. She has been treating that with Vaseline intensive care and Aloe. Her skin is very dry and crepey

completely covered with a rash; I was very tired; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 03Feb2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included thyroid disorder; patient also stated, "I have sinus and allergies because I am allergic to dust. Dust is everywhere. I get the runny nose." Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid. The patient reported "I have the vaccine on 3rd of this month and I had the Pfizer one and I was fine except I was very tired. I ended up going bed around 8 O'clock which is not like me but I was just so tired and then I woke up around 10 O'clock completely covered with a rash. So I took I had and allergy pills that had Benadryl in it so I took that and went to the bed. Next day all of it was gone. It was little bit left on my right cheek and my neck. I don't know if I still go for the other vaccine, this 24 or not. I didn't have temperature or anything." About the start date of the event, the patient further stated, "It was the 3rd between 10 or 10:30 in the night. It was 9 hours after I had the shot. I didn't have reaction right away, I was fine except I was tired, 9 hours later I have the rash." The patient stated that she was fine. Treatment for the event rash includes allergy pills that has Benadryl. The patient also asked if it was okay to go for second shot on the 24th. The patient was recovering from the rash while outcome of tiredness was not yet recovered. Information about lot/batch number has been requested.

Noticed small, scattered bruises inside left thigh; they went away with time. After second vaccine 3/1 I began to have leg cramps at night, after 1 week still tired and sore.

A week after Pfizer injection, I got a raised, red area about 2 or 3 inches by five inches on my arm. It was hot and very itchy. Over the net two weeks it got larger, but less red. It was gone about the time I received the second shot, After the second shot, I got the rash sooner, but it was larger and not raised or hot It lasted several weeks. I took antihistamines and tried Cortisone cream. They didn't seem to help

4 days after injection where shot was given it hurt deep. In the morning it was itchy, inflamed and hurt. deep pain in areas down to fingers.. enflamed area has increased still with itching and deep pain along the arm and fingers.

pain at injection site, patient states she flinched due to the extreme pain in left arm x 2 weeks. In addition, pain in both hands x 2weeks. Has taken Tylenol with no relief. Referred to primary provider

Right arm soreness/pain extending from a couple of inches below injection site to a couple of inches above the elbow on the outer part of arm; client used heat and Tylenol

Next day after receiving vaccine, Patient had Itching a few inches below injection site. No redness, No swelling, No rash, No hives, No effect on breathing. Two days after receiving vaccine, itching improved but not fully resolved.

On or about March 16, 2021, my left ankle swollen and hot to touch; sought and received medical treatment on March 25, 2021, and after a dobbler and ct scan was diagnosed with bilateral pulmonary emboli. Treated at Emergency Department and placed on Eliquis 5mg x 2 @ day for 7 days and then for 23 day - 1tab x 2 a day.

Sore arm, headache and redness (particularly left beast) itching and felling as though my skin is hot. Mostly upper body.

2 days after receiving vaccine - pain above kidneys on right side back continuing for 5 days, then next day stabbing pain starting above right kidney in back and shooting up to base of right shoulder, then next day stabbing paid on right side starting at the waist and shooting up ribs, then next day rash appeared on back and right side continuing to front to belly button. Turned out to be severe case of shingles. I had the shingles vaccine several years earlier.

All-over body rash/Terrible red rash down legs, more on left arm than right arm; Red, chapped skin on both sides of her legs/ Rash gradually cleared from dark red to light red to pink and disappeared; Rash as blotchy, bumpy, ugly, and sensitive; Rash as blotchy, bumpy, ugly, and sensitive; This is a spontaneous report from a contactable consumer. An 80-years-old female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EL3247; Expiration Date: 21May2021) via an unspecified route of administration in Arm Left on 26Jan2021 15:00 as single dose for covid-19 immunisation. Medical history included dental care from Jan2021 to an unknown date. Patient's Medical History (including any illness at time of vaccination; Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity) None. There were no concomitant medications. Co-suspect medication included amoxicillin (AMOXICILLIN), oral from Jan2021 (Batch/Lot number was not reported) and ongoing, at UNK, (2 tablets by mouth right away, then 1 tablet by mouth twice daily for a week) for dental discomfort. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. On 27Jan2021, the patient had all-over body rash. The patient states she woke up the next morning to red, chapped skin on both sides of her legs. The rash move down both of her legs, then both arms, but more prevalent on her vaccinated arm (left arm). She describes the rash as blotchy, bumpy, ugly, and sensitive, but not very itchy. Both sides of my legs by my hip looked kind of red, like chapped. Terrible rash all the way down both of my legs. Both arms- more prevalent on left arm and a little blotchier than the Bump ugly rash - called MD took some Benadryl- on a Steroid and the rash went away. Sensitive but not really itchy- just ugly. States she woke up Wednesday and took a shower and noticed on both sides of hips and wonders what it was since the areas was reddish. By the Wednesday evening there was a red rash down the legs from the hips to the ankle. It has cleared up. It gradually got better each day for 5 days. Was treated for the rash with Prednisone 20 mg tablets, where she took 3 tablets for 3 days, 2 tablets for 3 days, 1 tablet for 4 days. Notified the doctor and was told to take Benadryl to help the rash and if she is concerned to have someone to look at it at the Urgent Care. Rash gradually cleared from dark red to light red to pink and disappeared. Outcome of the event was recovered in 2021.

I was suddenly like I was going to die; Upper arm was big, bruised, and there is a lump; Upper arm was big, bruised, and there is a lump; It looks like hematoma like a node; that it was a hematoma; There was a Swelling wound; Was a little sore on upper left arm; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose, via an unspecified route of administration, administered in Arm Left on 20Feb2021 (Batch/Lot Number: EL9266) at the age of 80 years, as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included unspecified pill taken for years. The patient received first dose of bnt162b2 Lot: EL9625 on 26Jan2021 at the age of 80 years. The patient experienced suddenly like she was going to die on an unspecified date, was a little sore on upper left arm on 20Feb2021, upper arm was big, bruised, and there is a lump on Mar2021, it looks like hematoma like a node; that it was a hematoma on Mar2021, there was a swelling wound on Mar2021. It was reported that the events occurred approximately 3 weeks after the 2nd dose, that upper arm was big, bruised, and there is a lump: it was traveling down a little bit closer to where her arm bends. Is getting yellow on top. Where her lump is, the blood is not. Stated it was falling down her arm. After cold compression it has gone down a little bit. Then the patient went for a visit and the nurse advised to put warm pack in every 3 hours. She took a picture of it. The doctor told her that it was a hematoma. It's not the whole arm it's just her whole upper arm, it will like 4-5 inches. The event suddenly like she was going to die was serious as life threatening. Therapeutic measures taken as a result of the events little sore on upper left arm, upper arm was big, bruised, and there is a lump, it looks like hematoma like a node; there was a swelling wound included cold and warm compression. The outcome of the events was unknown.

Resident was on Macrobid for UTI, received 2nd dose of Pfizer, presents with blotchy red rash on body, no respiratory symptoms noted, no pain, no itching or irritation. Patient is stable

high blood pressure; cholesterol; flutter; her hands were red and felt warm; heart pains; she wakes up groggy; pain in middle of her chest; she felt tired/she feels worse; her arm hurt; her hands were red and felt warm; her legs felt heavy; This is a spontaneous report received from a contactable consumer, the patient. A 79-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 04Mar2021 at 17:15 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history included blood cholesterol increased from 2011 and ongoing; diagnosed 10 years ago, hypertension from 1991 and ongoing; diagnosed 30 years ago, chest pain from an unknown date and unknown if ongoing. Concomitant medications included atenolol taken for blood pressure from an unspecified start date and ongoing; benazepril hydrochloride, hydrochlorothiazide taken for blood pressure from an unspecified start date and ongoing; nifedipine taken for blood pressure from an unspecified start date and ongoing; simvastatin taken for blood cholesterol increased from an unspecified start date and ongoing. The patient experienced she was having issues with her heart/she also has pain in middle of her chest like heart pains/seems like more pressure and sort of constant, her hands were red and felt warm, high blood pressure, cholesterol, flutter, her legs felt heavy on 04Mar2021, she felt tired/she feels worse on 06Mar2021, she wakes up groggy, her arm hurt on 04Mar2021, she was having issues with her heart/she also has pain in middle of her chest like heart pains/seems like more pressure and sort of constant. Her hands were red and felt warm, had high blood pressure, cholesterol, flutter, her legs felt heavy, she felt tired/she feels worse, she wakes up groggy, and her arm hurt. She states that she could hardly sleep on the left side, so she is going to have it on the right next. The chest pains started a few weeks ago and it started before the vaccine but now it seems like more pressure and sort of constant, not a pain, pain but a pressure that she knows is there. Now and then she feels a flutter. Clinical outcome of heart pain was not recovered, for hands were red and felt warm, high blood pressure, cholesterol, flutter, she felt tired, she wakes up groggy, pain in middle of her chest was unknown, her legs felt heavy, her arm hurt was recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.

Patient is a 80 y.o. female who presents with: 2 months of itchy rash that started 2 months ago after 1st COVID vaccine. Was only on her lower leg. After the 2nd shot a month ago the resh got worse. It is on her arms, chest, upper and lower legs. It itches and she has been scratching it and picking it to where it is all scabbed up and hurting with redness. Discharged with Cellulitis, unspecified cellulitis site - Primary Relevant Medications clindamycin (CLEOCIN) 300 MG capsule mupirocin (BACTROBAN) 2 % ointment fexofenadine (ALLEGRA) 180 MG tablet Came back to doctor office 8 days later with complaints: Patient was seen on 3/30 and was treated with Clindamycin and Mupirocin. Patient did not f/u with Derm. Per patient and husband everything seemed to be healing except an area over her right breast and her left lower leg is now hot and swollen. Patient still complaining of itching and admits to itching until she breaks skin. NO fever reported. Admission to hospital for IV antibiotics

a "good size red patch" at injection site that is hard, swollen, red.; a "good size red patch" at injection site that is hard, swollen, red.; a "good size red patch" at injection site that is hard, swollen, red.; Red, swollen, itching and kind of arm at injection site on left arm; This is a spontaneous report from a contactable consumer. A 80-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: 9809), via an unspecified route of administration, administered in left arm on 04Feb2021 at a SINGLE DOSE for covid-19 immunization. Medical history included breast cancer. There were no concomitant medications. 08Feb2021 the patient experienced a "good size red patch" at injection site that is hard, swollen, red patient also reported red, swollen, itchy, and kind of hard area at the injection site. 7 days of Cefalexin (antibiotic treatment) was given from an urgent care. The patient stated that she wanted to report a reaction to the first COVID shot. She is due for her second shot on 25Feb2021. The outcome of the events was not recovered.

4-12-21 10AM TC: PT STATES SHE HAS BEEN ITCHING. HAS NOT TRIED BENADRYL. ADVISED TO CALL PCP IF BENADRYL DOES NOT HELP FOR OTHER OPTIONS.

Rashes appeared first on left arm anticubital area on Tuesday morning @ 7:00 o'clock 04/06/2021. More appeared everyday right arm, chest below the clavicles, abdomene=, left upper thigh, left armpit. both shoulders, behind right knee. Notified my PCP 09/20221. Appointment to see my PCP Wednesday 04/14/20121 at 8:40 am. Used Cortisone 10 OTC. The areas of the rashes are itchy.

Knot has developed on arm where the vaccine was administered - the arm has become swollen and the pain is increasing and not decreasing pain.

inflamation; My left hand became very red; very servere itching; sever head pain; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 01:30 (Batch/Lot Number: EL9265) as single dose for covid-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication included rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported. On 01Feb2021 13:00, the patient experienced inflamation, my left hand became very red and very servere itching, sever head pain. The action taken in response to the events for BNT162B2 was not applicable. Therapeutic measures were taken as a result of inflamation, my left hand became very red, very servere itching, sever head pain. The outcome of events was Recovering.

shingles rash burning, itching, and pain; shingles rash burning, itching, and pain; shingles rash burning, itching, and pain; shingles rash burning, itching, and pain; Chills; Fatigue; Shingles; This is a spontaneous report from a contactable consumer.A 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 14:30 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation. Medical history included Mitral valve prolapse, thyroid surgery, sleep apnoea. The patient's concomitant medications were not reported. On February 26th she got her first dose of the vaccine, and she is scheduled to get the second April 8th. She says on March 8th she was diagnosed with shingles. Her shingles rash she really didn't have long, it has almost faded now, it is almost nothing as far as scabs. She says she still has the burning, itching, and pain, but today it is not so bad. She says she sometimes has chills, which is one of the things that goes along with it, and fatigue. She says her concern was about this too, because even though the rash is gone she still has symptoms, does this mean her shingles are still active. She says she asked her pharmacist and they said it could still be active. her first dose of the vaccine was given in the afternoon, probably 02:30PM. She says she was diagnoses with shingles on March 8th after a visual diagnosis. Pfizer COVID-19 vaccine NDC/EXP: Not provided on handwritten vaccine card. AE Treatment: Caller says for the shingles her doctor hasn't said anything, she did get a prescription which she took, of 3 tablets a day for a week, so 21 tablets. She says she was also prescribed an ointment that she was putting on. She says that the tablets were Valacyclovir 1 gram, and she took one tablet by mouth three times daily for 7 days. She says this medication was dispensed in a pharmacy bottle from pharmacy, NDC/LOT/EXP were not provided on pharmacy label. Caller says the ointment was Triamcinolone Acetonide ointment USP 0.025%, which was applied usually before bed around 10:00PM-10:30PM. She says the label on that says apply externally to affected area twice daily for 15 days, but she applied it only once a day. Caller says that the EXP on the tube is little, it is July 2022, LOT: Unknown, unable to see on the tube. NDC: Caller says this is very, very little, she needs her magnifying glass, it looks like it is 45802-054-35. She says that the NDC is almost not on there, it is so little. Outcome of shingles, rash,burning, itching, and pain was recovering, of chills and fatigue was unknown.Therapeutic measures were taken as a result of shingles. No follow-up attempts possible. No further information expected.

A bruise appeared immediately; This is an initial spontaneous report from a contactable consumer. A 80-years-old female patient received frist dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in left arm on 13Apr2021 18:40 at a single dose for COVID-19 immunization. No medical history and concomitant medications were reported.The patient had a bruise appeared immediately, they put a Band-Aid over it, it spread about 2 inches in diameter on on left arm at injection site. She had the vaccine first one Tuesday, it never hurt, I didn't even have to take Tylenol. She don't know if it was a reaction to that or the Xarelto, it is local, never got reddened or anything. Her second dose of vaccine scheduled on 04May2021.The outcome of the event was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

She got the vaccine, had no reaction at all. Then on Saturday morning she noticed that there was a red circle light pink circle on her upper arm, about in the area of the injection. Then over the next few days it got hot to touch, and the redness slowly started to spread. Right now it has spread down to the inside of her upper left arm, and is very itchy. She looked for a bug bite but has not seen one. She called her pharmacist yesterday and he suggested that this often happens with this particular reaction to that vaccine and told her to take Benadryl and to put cortisone cream on that area, but the area is still hot to touch, red, itchy and hurting.

Severe diarrhea for three days, Extreme swelling of stomach. Extreme abdominal pain. Additional swollen area on left side of intestines. Shingles like pain in abdominal skin and flesh.

Bacterial infection; Shingles; she broke out in a rash; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 12:00 (Batch/Lot Number: EL8982) as SINGLE DOSE for COVID-19 immunisation; adalimumab (HUMIRA), via an unspecified route of administration from Nov2020 (Batch/Lot number was not reported) and ongoing, at 40mg (0.4mi) self injection every two weeks/She gets it twice a month) for psoriatic arthritis. Medical history included hypertension, diabetes type II, low thyroid, high cholesterol, chickenpox and she had part of her thyroid removed and psoriatic arthritis from an unknown date and unknown if ongoing. Concomitant medications included pravastatin taken for blood cholesterol increased from an unspecified start date and ongoing; ezetimibe (ZETIA) taken for blood cholesterol from an unspecified start date and ongoing; dulaglutide (TRULICITY) taken for type 2 diabetes mellitus from an unspecified start date and ongoing; azilsartan kamedoxomil (EDARBI) taken for blood pressure from an unspecified start date and ongoing; doxazosin taken for blood pressure from an unspecified start date and ongoing; l-thyroxine [levothyroxine] (L-THYROXINE) taken for low thyroid from an unspecified start date and ongoing; metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET XR) taken for type 2 diabetes mellitus, start and stop date were not reported. The patient previously took enbrel for psoriasis and experienced psoriatic arthropathy, enbrel for psoriasis and experienced psoriasis, and a flu shot. The patient was an 80 years old with compromised health because she takes a biological medication. On 20Jan2021, she had her first dose of COVID19 vaccine. No sore arm and everything was fine. On 27Jan2021, she broke out in a rash on her right lower arm between the elbow and wrist. She thought it was an allergy. When she thought it was more than that she went to the doctor. Diagnosed on 29Jan2021 with shingles. She was immediately put on the protocol of Gabapentin and Valtrex, the antiviral. It got worse. She gave it one more day and yesterday she went to the doctor. She has a bacterial infection on top of shingles. She is on the second day of antibiotic. Her question is her second Pfizer COVID19 shot is scheduled for 10Feb2021. Should she take it? Is it safe to do that? She also wanted to report it so it would be part of the database in case other people break out. She wasn't allowed to take the Shingles vaccines because the doctors did not want her to because of her compromised system. She has not had Shingles vaccine, but she did have chickenpox when she was younger. The rash is raging and like a flesh eating monster. It is bacterial and shingles. The patient was on gabapentin strength: 100mg. She took one a day for three days and now is up to three a day. The patient's glasses are giving her trouble. She is nearly useless with all this going on. She had to get her husband to read the pharmacy vial for her. The patient was on Valtrex taking generic called Valacyclovir. It is 1 gram tablet. Taking it three times a day. NDC, lot, and expiry: product in a pharmacy vial. The antibiotic she was put on was Doxycycline Hyclate 100mg twice a day. NDC, lot, and expiry: product in pharmacy vial. The biological medication she takes is Humira. She gets it twice a month. It is given by self injection with 29 gauge. She has been on a biological for 10 years. Before Humira she was on Enbrel. When she was put on Enbrel she had psoriasis and psoriatic arthritis. Enbrel took care of psoriasis. She still has psoriatic arthritis. They are gong to switch her to a new medication. She thinks it is called Talk, but she is not sure. She is waiting on the insurance to approve it. She has not started that yet. She thinks Gabapentin is affecting her vision. On the COVID19 vaccination card the information that said Pfizer, lot number, and date were on a little sticker that was taped on the card. Caller had to get her husband to read it to her. For the healthcare professional it was initialed. The patient doesn't want to die of Shingles either. These shingles are bad. She took the COVID vaccine because her health is compromised. She has hypertension, diabetes type II, and Psoriatic Arthritis. They qualified her for conditions along with her age. She thinks she stays positive because she doesn't dwell on this all the time. She just does it. She hasn't taken Humira since the diagnosis of Shingles because she has always been told to stop the biologic if she has an infection. She has been holding the Humira. It was due this week, but she did not take it. The outcome of the event rash was not recovered. The outcome of the rest of the events was unknown. The action taken of adalimumab for the events was temporarily withdrawn on unspecified date. Follow-up attempts are completed. No further information is expected.

One week after receipt developed pain at the injection site, followed by progression to her shoulder to her elbow and wrist, with edema distal to her mid elbow. She reports the second injection seemed less careful and the site was too high. She has normal strength and reports her baseline is very strong as she has played tennis for 40 years. The pain has continued to increase and went to community ER 14 APR 21. EKG, U/S were normal. She is trialed Tylenol and NSAID and they have helped. Symptoms mostly resolved on f/u 06 May 2021. She occasionally gets a small amount of burning pain in her deltoid, but it is not significant. She is otherwise well.

I had a slight fever; I just did not feel good; underneath it, it was kind of red; I was terribly tired for about 10 days; This is a spontaneous report from a contactable consumer (patient). This 80-year-old female patient received second dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 06Apr2021 as single dose for covid-19 immunisation. The patient medical history included liver disease, primary biliary cirrhosis, 3 different times had stomach ulcers, breast cancer for at least 15 years and high blood pressure. The patient concomitant medications included ursodeoxycholic acid (URSODIOL) 300 mg 3 times a day for primary biliary cirrhosis, metoprolol (METOPROLOL) 50 mg once a day orally for high blood pressure, amlodipine (AMLODIPINE) 5mg once a day for high blood pressure and water pill for high blood pressure. The patient historical vaccine included first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration as single dose for covid-19 immunisation and experienced tiredness for quite number of days. On an unspecified date in 2021, the day after the vaccination patient had slight fever, temperature. The patient did not feel good and area where she had vaccination, underneath it was kind of red but it was not warm or anything. The patient felt terribly tired for about 10 days. The patient did not receive treatment for events. The patient stated still not experiencing events and improved. The patient informed that she had no lab tests lately. The outcome of the events was recovered on 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

First dose March 24, second dose April 14. About a week later developed facial swelling. Was seen by her primary MD and given antibiotics for presumed facial cellulitis (clindamycin and cephalexin). The facial swelling improved but then her right eye became red with worsened vision (3 days prior to presenting to ophthalmology). Exam found new onset of inflammation of the conjunctiva and all internal structures (panophthalmitis). She is a long-time patient at the eye clinic since 1993 and has never had inflammation in either eye prior to this episode. There is no other explanation for the sudden presentation of an acute inflammatory condition.

shingles; rash on right inner thigh; leg was painful and tender to the touch; didn't sleep well; This is a spontaneous report from a contactable consumer (reporting for herself) via the medical information team. An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Feb2021 (Batch/Lot Number: EN6203; Expiration Date: Jun2021) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included surgery in the fall for cervical disc and cholesterol. Concomitant medication included simvastatin taken for cholesterol, start and stop date were not reported. On 25Feb2021 (reported as "the next day"), the patient noticed on her inner right thigh it felt like a rash but there was nothing there, but it felt like there was. The leg was painful and tender to the touch. The patient also didn't sleep well and talked to someone on 27Feb2021 (reported as Saturday) and said it sounds like shingles to them. The patient talked to the doctor and they felt like it was shingles. The doctor put the patient on medication which has really helped a lot. The rash was not getting worse, it has just stayed a little better and the same. The doctor prescribed her prednisone and valacyclovir, 1mg three times a day. The rash seemed to get worse in the evening, it was painful all around her leg, she thought it was a blood clot, but then realized no because the pain was on the outside it doesn't feel like it was on the inside. The rash wasn't red, Friday late afternoon it started being raised. The pain in her leg was sensitive but not like it was. The patient has kept her leg covered, its impossible to do this because of where it was on her leg. The pain was worse Friday night, the patient was able to sleep Saturday night, it was still sensitive. The outcome of the event didn't sleep well was recovered on 27Feb2021 while the outcome of the other events were recovering.

Burning of mouth, lips, difficulty breathing. Lips swelled, cracked and peeled. Inside of mouth no longer burning , Swelling in lips has gone down, they have been peeling for days. Lips are red, still sore, but I'm hoping they are done peeling. I really don't feel I can handle another shot of this vaccine. I think I may have to cancel the second shot. I don't know what is it it, everyone keeps telling me it has no penicillin or sulfa drugs in it, but the symptoms are the same. The only difference is my hands haven't cracked and peeled along with my lips and mouth. I've had these problems since last tuesday night and am taking Benadryl trying to get some relief from it still. Please let me know if you have any solutions to prevent this.

10 hours after vaccine, very short of breath. Vaccine site very sore, red and bruised, entire upper arm. Paramedics called, not transported to hospital. Advised to not take 2nd dose. Benadryl given orally.

chills/terrible chills; throat raspy was with a dry mouth; throat raspy was with a dry mouth; headache; "red puffed up" fingers/her finger tips got red and she had swollen red hands; "red puffed up" fingers; muscles hurting; allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer via a medical information team. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EL1283; Expiration Date: 30Apr2021), via an unspecified route of administration, administered in Arm Left on 22Jan2021 10:00 as SINGLE DOSE for COVID-19 immunization. Medical history included breast cancer survive (diagnosed in 2008), Allergies: latex, Allergies: sulfa. There were no concomitant medications. The patient previously took ciprofloxacin [CIPRO] and experienced Allergies, influenza vaccine (FLU VACCINE VII) (flu shot) for immunization and experienced no adverse event. The patient experienced headache on 22Jan2021 10:10, "red puffed up" fingers/her finger tips got red and she had swollen red hands on 22Jan2021 10:10, "red puffed up" fingers on 22Jan2021 10:10, chills/terrible chills on 22Jan2021 11:00, throat raspy was with a dry mouth on 22Jan2021 10:20, muscles hurting on 22Jan2021. It was reported on the COVID vaccine that the patient got the first shot on 22Jan2021 and was sent an email that her second dose was scheduled for 05Feb2021, was that ok. It was also noted when she got the first vaccine they held her up at the location because she has allergies. After getting the shot, her finger tips got red, her throat got raspy, and she got a headache. When she got home she had terrible chills and her muscles hurt. It was clarified that her finger tips got red and she had swollen red hands- this started 10 minutes after the injection was given and continued on and off for about a week. Throat raspy was with a dry mouth- this started 20 minutes after getting the shot and lasted about a week and a half. Headache - this started 10 minutes after getting the shot and lasted 3-4 days. Terrible chills- this started about an hour after getting the shot and lasted about 5 hours. Muscles hurting- this started that day and lasted 2 days. She reports she went to the emergency room 2 days later on 24Jan2021 and was given an antihistamine and told to take 2 Benadryl before the second shot. Since she was told she had an allergic reaction to the vaccine she was nervous about getting the second shot, what should she do. The outcome of the events headache, "red puffed up" fingers/her finger tips got red and she had swollen red hands, "red puffed up" fingers, throat raspy was with a dry mouth and allergic reaction to the vaccine was recovered on an unspecified date in 2021 and the events chills/terrible chills was recovered on 22Jan2021 16:00, muscles hurting was recovered on 24Jan2021. Follow-up attempts are completed. No further information is expected.

cut her left thumb right across the top with a cat food can lid; couldn't vacuum because she was so weak.; felt that she needed to lay down because she was so tired; felt like she had the full blown (COVID-19) Virus; regurgitating; nausea hit her like 'bang'; little bit of diarrhea; Weakness; felt deathly ill for a month; vomited up the Cephalexin 500mg; lost 25 lbs. in a month and a half.; very acute bronchitis that hit her after her first COVID-19 Vaccine; coughed and coughed for about 2-1/2 weeks; thought she had whooping cough; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 at 15:30 at the age of 80 years old (Batch/Lot Number: ER8727) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included uterine cancer (uterine cancer at 28 years old, had surgery for the uterine cancer); renal cancer (kidney cancer battled for 8-1/2 years. did not want another surgery, doctors did liquid cobalt treatments); nasal cavity cancer (had surgery to remove the cancer on nose about 7-8 years ago. had big hole taken out of her big Irish Cherokee nose. Thought the cancer was from her cat always hitting her with its claw on that side of her nose), bronchitis ( all her life) , radiotherapy (liquid cobalt treatments) , arthritis in back , kidney infection, pertussis, cytogenetic abnormality (missing half of a chromosome). Concomitant medication included estrogen nos (ESTROGEN NOS) 0.06 mg, 1x/day half of the pill in the morning, taking estrogen since she was 48 years old, meloxicam (MELOXICAM) 15 mg, 1x/day half of the pill at night for three years for arthritis in her back, cefalexin (CEPHALEXINE) taken for kidney infection, start and stop date were not reported. The patient previously took B12 shot every month (no additional information provided. No Additional Vaccines were Administered on Same Date of the Pfizer Suspect. No other vaccines were given within 4 weeks. The patient experienced felt like she had the full blown (COVID-19) Virus, regurgitating, nausea hit her like 'bang', little bit of diarrhea, Weakness, felt deathly ill for a month on 28Mar2021; lost 25 lbs. in a month and a half, very acute bronchitis that hit her after her first COVID-19 Vaccine, coughed and coughed for about 2-1/2 weeks, thought she had whooping cough, vomited up the Cephalexin 500mg on Mar2021; felt that she needed to lay down because she was so tired, couldn't vacuum because she was so weak on 09Mar2021, cut her left thumb right across the top with a cat food can lid on 10Mar2021 Treatment was given for cut on left thumb received 7 stitches in her left thumb on 10May2021 and bronchitis. Relevant Tests were reported as None. The clinical course was reported by the patient as follows patient received her first COVID-19 Vaccine dose on 28Mar2021 at about 3:30PM, and by 6:30PM, she felt like she had the full blown (COVID-19) virus. She stated started regurgitating. The nausea hit her like 'bang' and she had a little bit of diarrhea, and was really weak. She felt deathly ill for a month. Today (10May2021) was one of the first days she got dressed, and was up for the whole day. She said some days, she could not get up for more than an hour or two, and then she would have to go back to bed because she was so weak. Her doctor told her since the second COVID-19 Vaccine dose was supposed to be a little rougher than the first COVID-19 Vaccine dose, he didn't want her to get the second COVID-19 Vaccine dose. She said she was 80 years old, and had always been very self-sufficient. Stated she beat cancer 3 times. The patient called her physician, and her doctor wanted her to go to the hospital but didn't want to go. The doctor told her to take Cephalexin 500mg for 2-1/2 weeks, and then drop down to 1 Cephalexin 200mg nightly. Caller mentioned she kept Cephalexin 200mg and Cephalexin 500mg on hand in case she had symptoms of a kidney infection because she lived in a mountain town, and wasn't close to her doctors office. Since she had a history' kidney cancer she had more kidney infections'. Patient would take Cephalexin 500mg if she was hit hard with a kidney infection, and she would take Cephalexin 200mg is the kidney infection symptoms were just starting. Patient vomited up the Cephalexin 500mg. She said she lived on ginger ale and water. She stated she lost 25 lbs. in a month and a half. She said she was trying to gain back some of her weight now. No further details provided. Patient developed a very acute bronchitis that hit her after her first COVID-19 Vaccine. She clarified she coughed and coughed for about 2-1/2 weeks. She said she thought she had whooping cough, and had no way to stop the coughing. She could not vacuum because she was so weak. She said she went outside yesterday, and was outside for 20 minutes. She said she felt so weak, she went inside and laid down on her couch. She said she fell asleep for 4 hours. She said her weakness was like nothing she ever experienced before. Felt energetic and would start to do something, and then felt that she needed to lay down because she was so tired. She said she would go lay down, and then wake up 4 hours later. She doesn't think she was positive for the COVID-19 Virus. No further details provided. Patient stated she cut her (left) thumb (right across the top with a cat food can lid) this morning. She said the clinic in the valley, put 7 stitches in her left thumb today. The clinical outcome of the events Regurgitating, Nausea, Diarrhea, Vomited recovered; weakness, Ill feeling, Acute bronchitis, cough was recovering, while the remaining events was unknown. Follow up attempts are needed. Further information has been requested.

feeling like I was going to pass out; Left side of left wrist turned very red, while in the middle of my wrist large white pockets of fluid appeared, looking like I had a large worm inside. Pockets have gone down but are still visible after 6 days.; while in the middle of my wrist large white pockets of fluid appeared, looking like I had a large worm inside.; severe hot flashes; chills; felt like I wanted to vomit; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old female patient received first dose of bnt162b2 (BNT162B2 Solution for injection) via an unspecified route of administration, administered in arm left on 12May2021 12:00 (Batch/Lot number was not reported) as first dose, single for COVID-19 immunization. Medical history included obesity, atrial fibrillation, cardiac failure from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took sulphonamides, beta methasone, prilosec. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. The patient was not hospitalized. On 12May2021 at 12:00 AM, Left side of left wrist turned very red, while in the middle of my wrist large white pockets of fluid appeared, looking like large worm inside. Pockets have gone down but are still visible after 6 days. The worst part, was that got severe hot flashes then chills, feeling like I was going to pass out. Then felt like wanted to vomit. This went on for 24 hours, but now has seemed to stop. The outcome of the events was recovering. Information about lot/batch number has been requested.

some sort of tear between her bowels and her urination tract; has come down with shingles/it is dawning on her that it is pain from the shingles; This is a spontaneous report from a contactable consumer, the patient's husband. An 80-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via an unspecified route of administration in the right arm on 20Feb2021 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162b2 (Lot Number: FL9265) at the age of 80-years-old, administered in the right arm on 30Jan2021 for COVID-19 immunisation. In 2021, the patient experienced some sort of tear between her bowels and her urination tract and shingles. The clinical course was as follows: The patient came down with shingles. It was unknown the date the shingles began for the patient as shingles was not suspected at first. It could have started maybe 2-3 weeks after the second dose. Then, as of 03May2021, the patient was hospitalized for some sort of tear between her bowels and her urination tract which required an unspecified operation to be performed the same day. At the time of the report, the patient was still in the hospital and the patient was in quite a bit of pain. It was assumed the pain was part of the operation. However, it was dawning on her that it was pain from the shingles and was worse than before. The clinical outcome of the shingles was not recovered, while that of the tear between her bowels and her urination tract was unknown. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.

a dark bruise on her chin / she found a bruise on her chin that was sore and tender; This is a spontaneous report from a contactable consumer (patient herself). A 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EL9263, Expiration Date was not reported), via an unspecified route of administration on 29Jan2021 16:00 (at the age of 80-year-old) as 1st dose, single for covid-19 immunisation. Medical history was not reported. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN, 81 mg once daily by mouth). Additional Information for Concomitant Products Baby Aspirin is- It is just preventative. She is not prescribed it, she just takes it. On 29Jan2021, patient states that noticed later that evening she had a dark bruise on her chin. patient does not remember hitting anything or running into anything that would have caused this bruise to form on her chin and she is asking if this could be a potential side effect of the vaccine. She denies any swelling of the face, throat or mouth. She denies any difficulty breathing. patient states, if you saw my face you would think I've been in a fight" and it was exacerbated but it is quite black and blue, she knows it takes time to go down. Patient noticed the bruise later the same day and it is still tender like underneath your chin towards the gland, it is fading but it is still blue. It is just a tad fading, starting to fade. She says she also takes a minor dose of a blood pressure medication that she cuts in half actually but she is not sure if there maybe properties of that with something in the vaccine that might have done it. No further information provided. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

big itching in the body/strong itching; pain in the back and stomach/hurts in her upper back; pain in the back and stomach/hurts in front of her upper stomach; broke out in rash all over her body; This is a spontaneous report from a contactable consumer or other Non-health care professional. An 80-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Jan2021 as 2ND DOSE, SINGLE for indication of COVID-19 immunization. The patient medical history was not reported. The patients concomitant medications were not reported. The following 4 days patient was fine and after that she described her side effects as big itching in the body, pain in the back and stomach - She went to Hospital and doctors were not able to give any treatment recommendations. She wants to consult with Pfizer about her condition and seek for recommendations. patient broke out in rash all over her body and she was concerned about it. Patient stated that she had a strong itching for three days. Reported that hurts upper back and front of upper stomach. Has insurance and no one answered what she needs. Stated that she is in the shower every half hour. Stated that the itching is bad and she wanted to know what to do. Stated that she is healthy and has no problems and she had the vaccine a week ago and did not have any symptoms until three days ago when the itching started very hard then her back thing and then her stomach thing. Stated that she had no symptoms from the first one. Patient had taken her second dose of vaccine a week ago and did not have any symptoms until three days ago when she experienced, strong itching (pruritis), hurts in her upper back/front of her upper stomach (abdominal pain upper), rash all over her body. Stated that she called Medical Information before and they did nothing. Case number not provided. Outcome of events was unknown. 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.

Patient only had faint faint bruising at her eye.; Patient's right eye became swollen; Looked like she had a black eye; She looked in the mirror and saw that her eye was a mess; This is a spontaneous report from a contactable nurse. This nurse reported for a 80-year-old female patient that an 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number, NDC number, expiry date; unknown), Reason for no lot number: of Pfizer covid vaccine: Other: Reporter does not have patient's patient record card. Is Pfizer covid vaccine a Pfizer product; Unspecified, Pfizer covid vaccine manufacturer; Unspecified, dose 2 via an intramuscular route of administration on 20Apr2021 (at the age of 80-years-old) as 2nd single dose for COVID-19 immunization (because of patient's family). Vaccination facility type was clinic. Patient's medical and concomitant medication (Prior Vaccinations (within 4 weeks): None) history were not reported. Family history was reported as none. Laboratory tests included CBC, INR, PT, WBC and unspecified labs done on an unspecified date with results as normal. Historical vaccine included first dose of BNT162B2, lot number, expiry date; unknown), time of vaccination, anatomical location of the vaccine administered; not provided on an unspecified date for covid-19 immunization. Reporter stated that when patient got her first dose of the Pfizer Covid 19 vaccine within 24 hr while brushing her teeth she started spitting out blood from end of Mar2021 to an unspecified date (not serious). Consulted her dentist and as per consumer "no abscess, so no cause or no reason for the bleeding. The bleeding also stopped." After her second dose, her right eye were swollen that made it look like a black eye. Asked consumer if patient has bleeding disorder to taking anticoagulant. She said no. Asking if we have any other reports just like this. Response: Told the consumer we don't have reports just like these and will be escalating her request. She wants to be contacted via email. Reporter is a Nurse Practitioner. Reporter is calling about the Pfizer covid vaccine. Reporter is calling on behalf of a patient who she seen today. Patient had an adverse reaction to the vaccine. Patient did not realize that she had a reaction to the covid vaccine. After the first dose of the covid vaccine, patient went home and within 24 hours, she was brushing her teeth and was spitting out a lot of blood. Patient went to the dentist and got a dental exam, the dentist said everything looked normal. The bleeding stopped, and the patient was fine. The patient waited three to four weeks between the first dose of the covid vaccine, and the second dose of the covid vaccine. After the second dose of the covid vaccine, patient's right eye became swollen, and looked like she had a black eye. This kind of happened so soon after patient received the second dose of the covid vaccine. Patient went to the emergency room, a eye doctor, and a hematologist. Everything ruled out negative. Everyone is thinking that this was a reaction to the covid vaccine. Reporter is wondering if anyone else has been having these symptoms. Reporter gave consent to contact patient directly if Pfizer has any follow up questions. Reporters first visit with patient was over the phone on 07May2021. Reporter saw patient today in person. Reporter thinks that patient received the first dose of the covid vaccine four weeks prior to the second dose of the covid vaccine. Confirmed this began after the first dose of the covid vaccine and reporter does know exact dates. Patient received the second dose of the covid vaccine on 20Apr2021. Patient woke up at 4:00 AM to go to the bathroom. Whenever patient went to the bathroom, she looked in the mirror and saw that her eye was a mess. Patient had no headache, or anything. After the second dose of the covid vaccine, patient had to go to the emergency room. Patient went to the emergency room on 21Apr2021. Patient showed reporter a picture of her eye. Reporter stated that it was quite swollen and black, and looked like patient got punched in the eye. Today, at patient office visit, patient only had faint faint bruising at her eye. Seriousness criteria: Not provided. Indication: Because of patient's family. Patient's adult children wanted her to get it so they could come and visit her. Causality: Reporter ruled out a lot of stuff. Patient went to see an oncologist. Reporter is still waiting to get access to those files. Reporter is going to call oncologist's office today. Reporter knows that they checked patient's PT and INR, and both were normal. Patient's WBC was normal. Patient's CBC was normal. The oncologist hematologist also ordered some labs, and they were all normal. Verbatim event relatedness to pfizer-biontech covid-19 vaccine was reported as related. The outcome of events eye swelling and eye contusion was recovering and for others was unknown. Information on the lot/batch number has been requested.

On Tuesday, May 20th, about two and half weeks after the first dose, my mom felt listless, tired, run down. She developed a cough, a lot of throat pain, headache, back pain, body aches. About a week after she began to feel sick, she developed shingles on Thursday, May 29th. She knew what it was immediately because she had shingles previously. She started anti-viral medication on Friday, May 30th.

It was an extremely painful shot. It was a screaming painful shot. Once I made it home my pinky finger was numb and I couldn't move my arm above my head. It was hard lifting my hands and arms.

Patient presented to walk up vaccination tent on 6/5/2021 complaining of her injection site being painful since 4/5/2021 when she received her second dose. Her deltoid on the right arm is very firm compared to surrounding skin and mildly tender to palpation. Her shoulder is very tender with movement. The area had no drainage, redness or warmth to suggest infection. She was referred to her PCP.

rash on lower back; This is a spontaneous report from a contactable consumer (patient). A 80-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), via an unspecified route of administration administered in Arm Left 02Mar2021 14:00 pm UNKNOWN, SINGLE DOSE for covid-19 immunization. Medical history included high cholesterol. The patient had not been tested positive for COVID-19 prior and post vaccination. The patient had no known allergies. Patient had not received any medications in two weeks. Concomitant medication included Desloratadine, Rosuvastatin and Multivitamins and all were taken for an unspecified indication. It was reported that after receiving the dose of vaccine the patient experienced rash on lower back on 05Mar2021. The patient did not receive any treatment to treat the event. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Reduced consciousness; Pain and swelling in the arm where she received the shot; Pain and swelling in the arm where she received the shot; Slight fever; Chills; Heart rhythms; Tiredness; Sudden severe headache; Imbalance; Trouble walking; Dizziness; Vertigo; Slight vision changes; Confusion; Numbness or weakness of one side of her leg; Numbness or weakness of one side of her leg; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO9269), via an unspecified route of administration in right arm, on 10Feb2021 at 14:15 (at the age of 80 years), as first dose, single dose, for COVID-19 immunization. The patient's medical history included stroke (few years ago), multiple hip transplants, and rheumatoid arthritis (for 35 years). The patient's concomitant medications included apixaban (ELIQUIS) and metoprolol tartrate. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a clinic. On 11Feb2021 at 16:45 PM, normal side effects felt are pain and swelling in the arm where she received the shot. In addition, the patient may have a slight fever, chills, heart rhythms, tiredness, headache, and imbalance (trouble walking) on 11Feb2021 at 16:45 PM. On the patient's first two days (starting on 11Feb2021 at 16:45 PM), the patient experienced dizziness or vertigo, slight vision changes, sudden severe headache, confusion or reduced consciousness, and numbness or weakness of one side of her leg. It was unknown if treatment was given for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient recovered from "Sudden severe headache", "Dizziness", "Vertigo", "Slight vision changes", "Confusion", "Reduced consciousness", and "Numbness or weakness of one side of her leg" in Feb2021; and from the other events in 2021. No follow up attempts are possible. No further information is expected.

had a red patch that was hot around the site; The muscles in her entire right arm are very sore and says that it's painful; had a red patch that was hot around the site; red patch on my arm was just red and hot and hard; The muscles in her entire right arm are very sore and says that it's painful; This is a spontaneous report received from contactable consumer (patient). An 80-year-old female patient reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9267, and Expiration date: Unknown), via an unspecified route of administration, administered in upper right arm on 25Feb2021 as 2nd dose, single dose for COVID-19 immunization. The patient's medical history included psoriatic arthritis, Deaf (I am on a 'casting' call phone because I am deaf) and the patient also took Penicillin (I was three years old saved my life). The patient's concomitant medications were not reported. The patient stated that she took lot of medications (unspecified) she had a set of "tremor", it was a long list. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9269, and Expiration date: Unknown) in left arm on 04Feb2021 as 1st dose, single dose for COVID-19 immunization. The patient had infusion of Simponi on 04Feb2021 the same day she took first dose of vaccine. No other vaccine was administered prior to first dose of COVID vaccine. It was reported that the patient experienced a side effect after getting the second dose of the Pfizer-BioNTech COVID-19 Vaccine on an unspecified date in 2021. Originally, she had a red patch that was hot around the site in the hand for about two weeks. The muscles in her entire right arm are very sore and said that it's painful when she reached. The entire arm was painful and uncomfortable, and it was getting worse. On an unspecified date in 2021, the patient was recovered from the event "red patch on my arm was just red and hot and hard" and outcome was unknown for the event "the muscles in her entire right arm are very sore and says that it's painful" Follow up needed, further information has been requested.

Discomfort in site for several weeks then finally left. Since then trouble with arm right arm lifting, exercising doing household chores. I am right handed.

This is a spontaneous report from two contactable Consumer or other non-HCP (Patient and Patient's Son). These two consumers reported for 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: EL9261; Expiry Date was not reported), via an unspecified route of administration in arm left on 02Feb2021, (80-years -old at the time of vaccination), as first dose, single dose for COVID-19 immunization. The patient's medical history included fall, she went to the hospital for this, was a year ago and diabetes mellitus. The patient's concomitant medications included Metformin that she could take it only when her blood sugar is up, and Flu shot had it 3 weeks ago. On 03Feb2021, the patient experienced face swelling, the swelling was mostly around the eyes as if she was sting, it looks like little water bags, it doesn't hurt, there was no pain, it was underneath both eyes and down the cheeks, just swelling, swelling feels warm to the touch, and the skin was red, it's not red all over but in patches on cheeks and below the eyes, there was also redness right below chin, and it stops at the chin and there was redness on the forehead. On an unspecified date, the patient underwent lab tests and procedures which included blood glucose: 98. The outcome of all the event face swelling was not recovered and the event swelling feels warm to the touch and the skin was red was unknown. Follow-up attempts are completed. No further information is expected.

low grade fever (99.7°F); His wife had a rash on the right side of her abdomen and inner thigh/rash on the right side of hrash on inner thigh of one leger belly/rash on inner thigh of one leg; diarrhea; vomiting/Throwing up; This is spontaneous report from a contactable consumer (patient husband). This report is regarding his wife. A 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/lot number: PHFEEL9263, Expiration date: Unknown), via an intramuscular route in the left arm on 28Jan2021 Thursday at 12:00 PM, as 1 ST DOSE, SINGLE DOSE for Covid-19 immunization. The patient medical history included cancer; however, she is cancer-free right now. The patient concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 30Jan2021 until 23:00 or midnight patient was fine, and the patient had experienced heavy 20 minutes being in the bathroom throwing up and having diarrhoea and in the morning rash on the right side of her abdomen about the size of a saucer and inner thigh and on 02Feb2021, a low grade fever (99.7 degree Fahrenheit). Her temperature never went higher than 99.7 degrees. Patient wanted to know if can expect these side effects from the second dose and could they be worse. The patient underwent lab test and procedure which included regular CBC (like whole bloodwork) on 01Feb2021, Monday. She doesn't have any test results to include. The clinical outcome of fever has subsided and outcome for the event rash on the right side of her abdomen and inner thigh of one leg was recovering, outcome for diarrhoea and throwing up was unknown. Follow-up attempts are completed. No further information is expected.

Huge bruise 50 cent dollar, did it get in the blood; Feeling like before surgery; This is a spontaneous report from a contactable consumer reporting for herself. An 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccine 80-year-old) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. on an unknown date, the patient experienced huge bruise 50 cent dollar, did it get in the blood; and had that feeling like before surgery. Patient questioned about what happens if administered in wrong distribution system. Clinical outcome of the events was unknown. 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.

The 1 smaller bruise is a different color reddish.; Large Bruise; small Bruise; small and large Bruise was reported as worsened.; The bleeding at injection site; Swooshing feeling/distinct feeling; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration on 29Jan2021 as 1st dose, single (High Up on the left) for covid-19 immunisation. Medical history included Pre-diabetic from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient received first dose on 29Jan2021. The swooshing soaring feeling was just immediate through the body upon a receiving the injection on the same day. The bleeding at injection site also occurred the same day 29Jan2021. The bruising she noticed the next morning, she was surprised she didn't think to pay attention to it the day she got the vaccine and so noticed it the next day after when she took off the Band-Aid on 30Jan2021. She arm was not sore but its just a discomfort more than any other injection however she heard on the news this was common. When she took the band-aid off the bruise was larger than the Band-Aid, it was larger than a 50-cent piece, Caller stated that she has pictures available. Caller clarified that she actually has 2 Bruises. 1 Large and 1 small. The small bruise looks like where the needle was injected, then next to it was the large bruise, the Bruises are adjacent to each other but has like a different make up. The 1 smaller bruise was a different color reddish. The larger bruise was purple, brown quite dark with a yellowish ring around. She again stated that she has a photo. The swooshing feeling only happened during administration, it lasted for a couple second after the shot. It lasted 15 seconds and went away, as if she wanted to fall over. The shot was like going under surgery. It was a distinct feeling. The large bruise seems strange, darker, and yellow around. The Small bruise looks brighter in color, more saturated in color, its not faded but getting more pigmented. Patient stated the product complaint includes she had received her first dose on 29Jan2021 she had bleeded when she received her first dose of vaccination, she stated that she had blood on her bandage, and she thought when she was going to surgery and she had shot in milder version and she had a bruise of size of 50 cent piece she thought this administration of vaccine might impact the development of antibodies. Covid Card: She needs a magnifying glass. Lot EN5318. It was a printed sticker on the card. Expiry Date is not on the card. The outcome of the events the bleeding at injection site, the 1 smaller bruise is a different color reddish was unknown and Large Bruise; small Bruise, small and large Bruise was reported as worsened was not recovered and Swooshing feeling was recovered on 29Jan2021. Follow-up attempts completed. No further information expected.

the site is a little sore and tender; She may have had a slight fever of 98.6; This is a spontaneous report from a contactable consumer or other non-healthcare professional. An 80-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2, intramuscular, administered in right arm on 04Feb2021 at 14:03 (Batch/Lot Number: EL9264, Expiry date was not reported) as single dose covid-19 immunisation. Medical history included ongoing thyroid and underwent knee replacement in Jul2020 and sometimes have trouble with it. The patient has family cancer history. Concomitant medications included rivaroxaban (XARELTO) (20 mg daily by mouth) taken as blood thinner from an unspecified start date and ongoing; levothyroxine (50 mcg, take once daily by mouth) taken for thyroid ongoing from an unspecified start date; prednisone (Blister pack take six, then five, and down to one daily by mouth for six days) taken for intervertebral disc degeneration from 21Jan2021 to 26Jan2021 (She was diagnosed with degenerative disc disease and the doctor put her on prednisone pack for her back pain). The patient did not receive any vaccinations within 4 weeks prior to covid-19 vaccine administration. The patient did not have any illness at the time of vaccination. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in right arm on 15Jan2021 at 09:57 (Batch/Lot Number: EL2346, Expiry date was not reported) as single dose covid-19 immunisation. On 04Feb2021, the patient experienced little sore and tender. On an unspecified date in Feb2021, the patient had slight fever of 98.6. Clinical course was reported as she received the second dose of the Pfizer COVID 19 vaccine 04Feb2021 1403PM in the right arm. Today the site is a little sore and tender. She may have had a slight fever of 98.6. The first time she felt great after the shot and was bragging to her friends about it. Add she thought the shot clinic was really well organized but when she went in to get the shot there was a guy sorting through the box and she wondered why. The events did not require any visit to physician office or emergency room visit. Outcome of the events little sore and tender was not recovered and slight slight fever of 98.6 was unknown. Follow-up attempts are completed. No further information is expected.

Felt weak; Dry throat; States she has noticed she has been burping a lot and coughing harder.; States she has noticed she has been burping a lot and coughing harder.; She has a dry cough and when she coughs hard she gags until almost vomiting/ she has had some coughing where she coughs until she feels like she has to throw up; she has been having shortness of breath that started when she got the first dose of the Pfizer COVID vaccine on 27Jan2021; Chills; she just felt tired was all; pain at the injection site in her right arm so she took Tylenol that morning; This is a spontaneous report from a contactable nurse (patient). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265) dose 1 via intramuscular route of administration in Arm Right on 27Jan2021 at 13:30(at the age of 80 years old) as single for COVID-19 immunisation. Medical history was none. There were no concomitant medications. Patient had no other vaccines on the same day as the COVID vaccine. The patient experienced as, she has been having shortness of breath that started when she got the first dose of the pfizer covid vaccine, chills, she just felt tired was all, pain at the injection site in her right arm so she took tylenol that morning on 27Jan2021, felt weak on 07Feb2021, she has noticed she has been burping a lot and coughing harder, she has a dry cough and when she coughs hard she gags until almost vomiting/ she has had some coughing where she coughs until she feels like she has to throw up, and dry throat on an unspecified date on Feb2021. Therapeutic measures were taken as a result of she just felt tired was all and pain at the injection site in her right arm so she took tylenol that morning. The patient underwent lab tests and procedures which included weight: 145-147 on an unspecified date. Therapeutic measures were taken as a result of she just felt tired was all and pain at the injection site in her right arm so she took tylenol that morning. Outcome of the event shortness of breath and chills were recovered and unknown for rest events. Information about batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.

the injection site is red and swollen/swelling with red silver dollar spots; arm is sore; she had a very red and tender arm; the injection site is red and swollen; This is a spontaneous report from a contactable consumer (patient herself). An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration, administered in right arm on 29Mar2021 14:20 (reported as Monday) (age at vaccination: 80 years) as DOSE 2, SINGLE for covid-19 immunization at Physician Office. The patient medical history was not reported. Concomitant medication included levothyrxoine sodium (SYNTHROID). The patient said that she was basically healthy. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in his right arm on 08Mar2021 as DOSE 1, SINGLE for covid-19 immunization. Patient was was okay with the 1st Covid shot. The night after the second shot, she had a very red and tender arm. The next morning, it was red and swollen and redder. It has been the same for the last 2 days. The arm was sore with red patches the size of 2 silver dollars. Patient took a Benadryl thinking that would help and used an ice patch. The arm was a little redder this morning. Caller added that pain wise and everything, it was about the same. The discomfort was about the same. The area was redder and the redness has worsened as in bigger than it was last night.The patient had no prior vaccinations within 4 weeks. The outcome of the event was not recovered.

Two weeks after Dose #2, I had 3 days of hives, my tinnitus reappeared after being gone several years, I got plantar fasciitis in my left foot (which after two months, I found online the cure is turmeric...took two a day for a week, and the plantar fasciitis was gone), got full-body sweats (unpredictable...they just come w/out warning). I have vax brain fog also.

rash appeared on upper back; very itchy; This is a spontaneous report from a contactable consumer, the patient. A 80-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in left arm on 25Feb2021 at 10:45 (at the age of 80-year-old) as single dose, for COVID-19 immunisation. Medical history included osteoarthritis. The patient has known allergies to tree fruits and some nuts. The patient neither underwent COVID-19 test nor had symptoms associated with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received PRESERVISION; calcium (MANUFACTURER UNKNOWN) started on unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9261) via an unspecified route of administration in left arm on 04Feb2021, as single dose, for COVID-19 immunisation. On an unknown date in Feb2021, a day or two after 2nd shot, rash appeared on patient's upper back; very itchy; over the past month, rash has moved down her back; on her arms, upper hip, abdomen. Therapeutic measures were taken as results of events and included treatment with Claritin 5mg to reduce itch & putting on gold bond psoriasis relief cream. Event didn't result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome for the events rash appeared on my upper back and itchy was recovering at the time of this report. No follow-up attempts are possible. No further information is expected.

I was having side effects during the vaccine a headache and then nausea, throat soreness, face redness, neck redness, rash on chest. Pain in lower abdomen. Pressure around left ankle.

pruritis/itching all over; she is still tingling around her shoulders and neck; This is a spontaneous report from a contactable consumer reported for herself. An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Batch/Lot Number: EN6200) via an unspecified route of administration on 20Feb2021 13:30, as dose 1, single for COVID-19 immunization. Medical history included ongoing blood pressure, ongoing cholesterol, and ongoing acid reflux. Concomitant medications included algeldrate, alginic acid, magnesium trisilicate, sodium bicarbonate (GAVISCON [ALGELDRATE; ALGINIC ACID; MAGNESIUM TRISILICATE; SODIUM BICARBONATE]); esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) taken as Antacid; vitamin d nos (VITAMIN D NOS); vitamin A; and blood pressure medicine (unspecified). On 20Feb2021 (Saturday), the patient got the first dose 20Feb2021 and the itching started after midnight. On 21Feb2021 at 02:00 AM, she experienced itching all-over, but it had diminished and was now on her shoulder and neck area. She noticed, it got worse after she has taken her reflux medication Nexium and Gaviscon and wanted to know the expected duration of this side effect. She mentioned that she had vaccine, Saturday at about 1:30 PM it was reported that it went fine but at about 2 AM she woke up itching and she didn't think anything about it and thought it would go way but continued and it gets worse when she takes her antacid. She quit taking her Nexium, it got worse with that antacid. It was a little better, but on an unspecified date in 2021, she was still tingling around her shoulders and neck and wanted to report it, but she also wanted to see how long she might have this problem or when would it go away finally. As her itching started after midnight and was fine until then which was why she thought it was something to do with her acid reflux medicine because she took it before she went to bed and then yesterday, she took Gaviscon, and the itching got worse. She says it was like Pepcid or something like that, it was an antacid. She also took her prescribed medication for acid reflux. It was improved but it was still there. Further she added that it was not like she itches and scratches all the time, but it was just there, mainly around shoulders and neck. She was startled she had any reaction because she did not right at first but might be people should know that you still could have a reaction. She took the Nexium that night before and she had taken all her medicines as well which was her blood pressure medicine, cholesterol medicine, Nexium, vitamin D and A vitamin. She had taken all of those the night she started itching. Last night all she took was her blood pressure medicine. She also had taken Tylenol and when she started itching like when it was bad, she took some, it was like allergy relief like Zyrtec (generic). Last night all she took was blood pressure medicine because she did not want to mess with anything. She had not taken any antacid since about 12 yesterday morning and the itching got worse than that was why she was thinking maybe that was the problem. Therapeutic measures were taken as a result of the events with Tylenol and Zyrtec. The outcome of the event pruritis/itching all over was resolving, while the outcome of the other event was unknown. No follow-up attempts are possible, no further information is expected.

Immediately I had "funny bone" pain in the opposite arm (right) of the injection. That comes and goes at night but less as time goes on. Left arm still hurts at the injection site. Main Problems: Headaches and extreme dizziness. I thought the dizziness was a UTI problem. I took 14 pills twice to get rid of the "UTI" effect as per my GP. The dizziness and headaches started after the vaccine and is getting worse and worse. The room is spinning when I get up at night or lay down to sleep and many times during the day. My husband cannot drive anymore and this problem is scary. I wish I did not get the vaccine. I believe I had Covid after holidays of 2019 and into Jan. of 2020. Serious coughing and could not breath. We we

developing itchiness, a little redness at the left breast a little below the waistline, itching in the scalp and the right eye; developing itchiness, a little redness at the left breast a little below the waistline, itching in the scalp and the right eye; itching in the scalp and the right eye; This is a spontaneous report from a contactable consumer (patient). An 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3302 and Expiration date: unknown), via an unknown route of administration, administered in left arm close to shoulder on 01Feb2021 around 02:30 (at the age of 80-years-old) as dose 1, single for covid-19 immunisation. Medical history included allergy unspecified from an unknown date. There were no concomitant medications. The patient previously took clonidine 0.1 mg, hydralazine 10 mg, cipro (ciprofloxacin) and sulfa for blood pressure abnormal and had itching. Patient also took spironolactone tablets for blood pressure abnormal and had a little rash of bumps under the skin on her right arm. On 01Feb2021, she received covid vaccine probably about 02:30. When she got home, about 2.5 hours later at 05:00, she started itching somewhat, a little redness at the left breast a little below the waistline, itching in the scalp and the right eye. There was nothing she could see in those places. She went ahead and called the pharmacist. The pharmacist told her to take Benadryl, so she took one 25 mg liquigel. It took the itch away. She went to bed and decided it had subsided. She decided to go ahead and take one more through for the night. When she woke up in the morning, she didn't have a problem. She was wondering if she should be concerned for the second shot. She didn't have a prescribing doctor. She got the invite to get it. It was gone through the night. Therapeutic measures were taken as a result of developing itchiness, a little redness at the left breast a little below the waistline, itching in the scalp and the right eye. Outcome of events was recovered on 02Feb2021.

Diarrhea for several days, Swollen face, shooting nerve pains in face and head, face painful to the touch, as if nerves inflamed. Doctor suspected shingles, but no blisters appeared. Pain stopped after five days. Swelling lasted a couple of weeks. Irritated nerve sensation in trunk persists,

Losing balance, leaning to one side; Diarrhea; Pain in legs cannot stand, pinching like small animals in body; Pain in legs cannot stand, pinching like small animals in body; Can barely walk legs hurt so much; Feels like she is dragging one leg; Itchiness on body; Feeling quite weird; This is a spontaneous report from a contactable consumer or other non hcp. This case was split to capture events after first and second dose of vaccine. This is the first of two reports, reflecting events after the 1st dose. An 80-years-old female patient received BNT162b2 (Pfizer Covid Vaccine, Solution for injection, lot number: EN0196, NDC and expiry date was unknown), via an unspecified route of administration, administered in Arm Left on 27Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine BNT162b2 (CONMINTARY, Solution for injection, Lot No: EN0164), via an unspecified route of administration, administered in Arm Left on as 07Jun2021 as 1stdose, single for covid-19 immunisation. Medical history included deep vein thrombosis from an unknown date and unknown if ongoing Verbatim: DVT Thrombosis Right Leg. There were no concomitant medications. The patient experienced itchiness on body on 27Jun2021 with outcome of recovered , feeling quite weird on Jun2021 with outcome of unknown , pain in legs cannot stand, pinching like small animals in body on Jul2021 with outcome of not recovered , pain in legs cannot stand, pinching like small animals in body on Jul2021 with outcome of not recovered , can barely walk legs hurt so much on Jul2021 with outcome of not recovered , feels like she is dragging one leg on Jul2021 with outcome of not recovered , losing balance, leaning to one side on an unspecified date with outcome of unknown , diarrhea on an unspecified date with outcome of unknown. Outcome of the events experienced itchiness on body was re-covered, feeling quite weird, losing balance, leaning to one side diarrhea was unknown, pain in legs cannot stand, pinching like small animals in body, pain in legs cannot stand, pinching like small animals in body, can barely walk legs hurt so much, feels like she is dragging one leg was not recovered .

On Tuesday, Jan 5 pm swelling four by six inches on upper right arm very red hot area . Area still the same at 7:30 pm on January 6.

Patient started gasping and wheezing about 10 minutes post vaccine injection. She turned red and gasped for breath. She started crying and hyperventilating. I used an EpiPen on her immediately within 2 minutes of her turning red and she seemed to calm down for a few minutes. She was able to talk and ask questions. We gave her water to drink but then she started crying again and seemed to have more anxiety. Paramedics came within 15 minutes and took over.

I received my vaccine at 10:39 a.m. About 8:30 p.m. I started to feel arm soreness at the site of injection. About an hour later (9:45 pm) I started to feel numbness around my mouth. When I got up the next morning (today) within one hour the numbness returned all around my mouth and lips.

Patient received vaccination around 10:30 am in her right deltoid. Around 10:35 am, the patient complained about local reaction/swelling at the site of injection. Upon physical examination, the patient right deltoid had some swelling and was hard upon touch. Patient stated similar reaction when she received the tetanus vaccine. When asked about taking benadryl, she stated that her doctor told her not to take benadryl but didn't state the reason so benadryl was not given to her. Patient was then escorted to the emergency department.

unrelenting itchiness all over her body for 2 days; soreness at the injection site; overwhelming sleepiness for quite a few hours after the vaccine; tired; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiration date: unknown), intramuscular (right upper arm) on 05Jan2021 at 11:45 at a single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. It was also reported that she had 2 shots in polio season in 1952 and did not go back for the booster. The patient had no prior vaccinations (within 4 weeks) following prior vaccinations. The patient had symptoms after the first dose of the COVID-19 vaccine, on 05Jan2021. Symptoms are as follows: soreness at the injection site, overwhelming sleepiness for quite a few hours after the vaccine. On 06Jan2021, the patient then had unrelenting itchiness all over her body for 2 days. The patient wanted to know if she can get the second dose, and if the second dose is stronger. She stated that she used to be 5ft 6in and stated that she still says that and did not want to confess that she is shrinking. She said that she took a 4-hour nap and was still tired and then took another hour nap. About 5 hours later, she was still tired and went to bed and slept until the morning. She stated that she normally goes to bed around 3am anyway and she had plenty of sleep that day. She said that she does not sleep all day and does not fall into a stupor. She received the injection on 05Jan2021. She said that she touched the injection site and she felt the soreness a few hours after receiving the injection. She clarified it was 5-6 hours after receiving the injection. She does not know the date when it went away. She said that she did not touch it again. The patient also said that she does not usually itch anyway herself; the itching went into the next day and was centered around the navel. The patient also said that she is no longer experiencing the symptoms that appeared. The patient also checked temperature with unknown results. The event soreness at the injection site and tired resolved in Jan2021, overwhelming sleepiness for quite a few hours after the vaccine resolved on 06Jan2021 while the event unrelenting itchiness all over her body for 2 days resolved on 07Jan2021.

fast heartbeat, dizziness and it took about 45 minutes to feel better. Had a bad taste in her mouth received Gatorade. On Saturday I felt nausea and just not feeling good and terrible taste in her mouth. Denies any shortness of breath during this entire time. Needed to eat to make her stomach to feel better, chills. injection site sore. Sunday felt better and Monday was almost normal and Tuesday no complaints.

a little sore on site on the first day; This is a spontaneous report from a contactable nurse (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EH9899, expiry date: 31Mar2021), via an unspecified route of administration on 21Dec2020 at a single dose for covid-19 immunization. Medical history included colitis, diverticulitis and allergies. Concomitant medications included chlordiazepoxide hydrochloride, clidinium bromide (LIBRAX [CHLORDIAZEPOXIDE HYDROCHLORIDE;CLIDINIUM BROMIDE]) for colitis, omeprazole (PROTONIX [OMEPRAZOLE]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for allergies, and cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID) for colitis. The patient experienced a little sore on site on the first day on 21Dec2020. Outcome of the event was recovered on 22Dec2020.

chills; tiredness; temperature was 100.8; sore arm with redness; sore arm with redness; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left arm on 12Jan2021 at a single dose for covid-19 immunisation. Medical history included covid-19 in Apr2020. There were no concomitant medications. On 13Jan2021, the patient experienced chills and tiredness and at the end of the day, her temperature was 100.8. The patient also experienced sore arm with redness in Jan2021. The patient stated that every once in a while, she get a shot and get a sore arm. She added that she noticed that her arm was more sore with redness that morning of reporting. The outcome of events chills, tiredness and temperature was 100.8 recovered on 14Jan2021, event sore arm with redness was not recovered. Information on the lot/batch number has been requested.

Approx 3 cm x 4 cm area of redness, warmth and itching at the injection site that developed over a week after the injection

developed herpes voster-pain behind the right ear and neck with rash and up into the head started on 1/26/21 and still present on 2/1-rash appears to be crusted over on 2/1/21

arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site; arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site; arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site; nauseous/nauseated; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, via an unspecified route of administration, on 13Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included COPD (chronic obstructive pulmonary disease) and diabetes and cancer surgery. The patient has unspecified concomitant medications ("she takes many"). The patient experienced being nauseous/nauseated when she got up this morning (25Jan2021). And her arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site. The patient underwent unspecified lab tests and procedures on Dec2020, results were also unknown. Patient took Tylenol as treatment to the events. Outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.

pain on her left shoulder where they gave her the shot/had pain where they she had the injection in her arm; To the point where she felt like she "was going to pass out"; kind of weak/ having "no energy"/ she does not seem to have the energy/ it just droopy; felt dizzy; She has not been sleeping good; having a funny feeling; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), intramuscularly on 15Jan2021 16:15 at single dose in left arm for COVID-19 immunization. Medical history provided as none. There were no concomitant medications. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. There were no vaccines received within 4 weeks Prior Vaccinations. The reporter stated she received the first dose of the COVID-19 vaccine on 15Jan2021 (Friday) and felt fine. She added it then made her kind of weak on next Saturday morning on 16Jan2021, to the point where she felt like she was going to pass out on 16Jan2021, but it went away after laying down. She stated she felt pain on her left shoulder where they gave her the shot on 20Jan2021 but is fine today (21Jan2021). Lastly, she mentioned having no energy. She asked if her symptoms were reported sided effects of the vaccine. She has been having a funny feeling in Jan2021 and does not know if it is from the vaccine. She clarifies that she does not seem to have the energy on 16Jan2021. When she got home she was ok, the next day after she got the shot, she thought she was going to pass out and felt dizzy for about an hour on 16Jan2021. She has not been sleeping good for the last few days since Jan2021 and states that may be why she does not have the energy. For event does not seem to have energy, reports it comes and goes, states it just droopy and it may be she had pain where they she had the injection in her arm on 20Jan2021. She is asking if this is normal. The patient declined any Treatment. The reported adverse events did not require a visit to Emergency Room and Physician Office. The reported stated it wasn't that bad. The outcome of event Dizzy was recovered on 16Jan2021. The outcome of the event "was going to pass out" was recovered in Jan2021. The outcome of event "pain on her left shoulder where they gave her the shot/had pain where they she had the injection in her arm" was recovered on 21Jan2021. The outcome of event 'kind of weak/ having "no energy"/ she does not seem to have the energy/ it just droopy' was not recovered. The outcome of the other events was unknown.

Patient reported systemic urticaria beginning approximately 5 hours following vaccination. Patient medicated with dose of diphenhydramine and symptoms abated soon thereafter with no further reported effects.

the arm was very sore all the way down to her elbow; Queasy; pasty frequent stool; pasty frequent stool; the outside of her arm where the vaccine was put hurt that day; This is a spontaneous report from a contactable consumer. A 81-year-old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1284), at single dose into the left arm on 16Jan2021 at 12:30PM for COVID-19 immunization. Concomitant drugs included Levothyroxine 0.100mg once daily by mouth taking for years for thyroid and a week and half before the vaccine administration, she had a cortisone shot in her hip for bursitis but it didn't work, it was the first time she has had one in a long time. The patient reported that on 16Jan2021 the outside of her arm where the vaccine was put hurt that day, but then the next day the arm was very sore all the way down to her elbow. But it was bad, she couldn't roll in bed form the pain. Then she woke up on 17Jan2021 queasy like morning sickness that didn't go away until 21Jan2021. Adds she also noticed that day she was having more frequent and pasty stools. Mentions she expected her arm to be sore because with the second shingles vaccine her arm was sore. States this was years ago and she did not have any product or information for the shingles vaccine. The patient is scheduled for the second dose on 06Feb2021. Mentions she lives in a continuous care facility and they will give her the shot. The event arm hurt recoverd on 20Jan2021, the other events resolved on 21Jan2021.

my right foot swelled up and turned bright red. It was incredibly painful. I couldn't walk. It lasted 2 days and then receded. I took 5 Tylenol for the pain in 48 hours.

Dizzy; Headache; Joint pain; Fever; Injection site swelling; heartbeat would accelerate for a few seconds; Chills; off balance; throwing up; she could not drive and was half delirious; I am not feeling good; sneezing; has no energy; her bowel movement was little dab and then again another little dab; if she does not blow her nose, it feels like something is going down the back of her throat; She still has a punchy feeling; she does not have her peripheral vision right; Her arm felt like a boil where they gave her the shot.; Her arm is still is sore; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982, Expiry Date of Pfizer covid vaccine: May2021), intramuscular injection in left shoulder on 21Jan2021 13:00 at single dose as preventative, since she did not want to get COVID again/there was a new strain of COVID that was easier to catch. Medical history included ongoing high blood pressure diagnosed about 5 to 7 years ago, ongoing high cholesterol diagnosed about 5 to 7 years ago, thyroid disorder, Supplementation, for bones, COVID-19 from Nov2020 to Dec2020: She had COVID in Nov2020 till the end of Dec2020, and she was getting better. Concomitant medication included ongoing metoprolol tartrate for high blood pressure, ongoing simvastatin for cholesterol, ongoing levothyroxine for thyroid, ongoing colecalciferol (VITAMIN D) as Supplementation, for bones. The patient experienced chills, off balance, dizzy, headache, joint pain, fever, injection site swelling, heartbeat would accelerate for a few seconds on 21Jan2021, throwing up in Jan2021. The patient spent that whole night getting up and down and going to bathroom for bowel movement, and her bowel movement was little dab and then again another little dab. She was throwing up by 3am or 4am that night, she threw up twice and reports it was like bubbles. Her side effects started Thursday night. She experienced chills, joint pain, fever, injection site swelling, her heartbeat every so often would accelerate for a few seconds. She dizzy and off balance when she would get up to go the bathroom. Since then she still had sneezing and she was blowing her nose, and if she did not blow her nose, it felt like something was going down the back of her throat. She wanted to ask how long she would experience the side effects and how many people had a problem with the first dose. She still had a punchy feeling, had no energy. She could lay down and fall asleep at almost anytime. Height: about 5'2'', she jokingly stated she was shrinking monthly. Her chills started Thursday night and by Saturday morning they were completely gone. When she tried to turn a corner and reported she did not have her peripheral vision right since she kept running into door frames. She was a little better, sometimes she could walk a straight line and sometimes she veers. Headache was ongoing. She did not have it today, it was not a severe headache, it was more irritating than severe. Her arm felt like a boil where they gave her the shot. Her fever went away Saturday night or Sunday morning. She felt like she was not in her own mind, like she was drifting, so time lines for side effects are hard to recall. Her arm was still was sore. Heartbeat would accelerate for a few seconds was occasionally still happening, it happened last night. She called the hospital (facility where it was received) back the next morning and she was told she could come if she wanted to but it was suggested to stay home and sleep it off. She told them she could not drive and was half delirious, she was told she could call an ambulance to come get her. She confirms she did not call ambulance or go to the hospital. When querying indication, she was told there was a new strain of COVID that was easier to catch. The outcome of events chills was recovered on 23Jan2021, vomiting was recovered on 22Jan2021, joint pain was recovered on 24Jan2021, fever recovered in Jan2021. The outcome of events balance impaired NOS, dizzy, vaccination site swelling, Peripheral vision defective was recovering. The outcome of event headache, sneezing, feeling of total lack of energy, feeling abnormal, sleep excessive and pain in arm was not recovered. The outcome of rest events was unknown.

"While in the waiting area after receiving her vaccination Pt. developed chest pain with changes in skin color. She denied any shortness of breath. BP 179/71 P 66 R16 SaO2 96% 911 was called Pt. was transported to hospital." Per RN. Paramedic documented. "Post vaccination pt started to become very light-headed and had near syncopal episode, also c/o chest discomfort over L anterior chest, denied any shortness of breath, Pt was evaluated 911 called, Pt was transported to hospital for evaluation w/VFD and AMR."

Developed blisters/rash on left buttock on Jan 31, 2021. I also felt extremely fatigued and had chills. I went to an appointment with a gynecologist for an unrelated chronic issue . (inflamed hemorrhoids) She examined my rash at that time and diagnosed it as shingles. Since that appointment the blisters began drying up. I continue to have itching, burning, and nerve pain on my left buttock.

Systemic: Allergic: Rash Generalized-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Other- exasperation of post-viral rash-Mild