Pfizer

Raised, red area with warmth and tender to touch. On right deltoid around injection site Kelflex 500mg TID x 7 days and ice packs until redness is resolved Reaction 12/27/2020 Resolved 12/29/2020

Patient is a 90-year-old female. She is a nursing home resident with and ongoing COVID 19 outbreak occurring . She has been diagnosed with corona virus on 1/4/21. She apparently has not eaten or drank anything in about a week. She was being hydrated at the nursing home with normal saline, but has failed to improve. She was sent to the ER and was admitted on 1/8/21 to hospital At no time during the hospital stay has she been more than minimal responsive. She need O2 for Comfort but on CXR and CT cardiopulmonary imagining was clear. Discharge note stated that he was requiring supplemental oxygen, but her chest x-ray on admission actually showed no acute cardiopulmonary disease. She was diagnosed with COVID-19 on 1/4/21. Most likely, this disease set her level of function back to the point that she was no longer eating and drinking, and she just overall rapidly declined after that. There was no evidence of an actual COVID pneumonia or pneumonitis. On 1/12/2021 family made patient a DNR and IVF were stopped and switched to comforted care. Patient expired 1/13/21

Patient noted to have a change in status at 11:23PM that night. Her oxygen saturation had dropped from normal on room air to 82% and required oxygen. She was also noted to be lethargic with altered mental status and not responding verbally. She then began to mottle. Her oxygen saturation worsened to 51% on 4Liters of oxygen by the next day and she expired on 1/14/21.

02/04/2021 2:15pm Felt Buzzed.. Energized ..Up lifted in Spirit 02/05/2021 2:00am Set up to go restroom.. slight Forehead Headache.. upon standing Dizzy unstable. Weak.. Used walk and furniture for support.. after seated on the toilet head pain increased.. Felt Nausea (did not Vomit)..headache passed.. returned to bedroom. This took 35 minutes 02/05/2021 2:35am seated on the bed.. felt Dry throat.. smelled Feverish ..Aches in Legs ..Right hand up to shoulder Stiffness(10minute duration).. 02/05/2021 3:00am felt fatigued.. feel asleep 02/05/2021 9:00am Awoke no issues.. 02/05/2021 10:30am Injection site left arm itchy.. no swelling .. no bruising.. tender to touch.. itchy sensation over full body

MY MOM DEVELOPED SHINGLES 10 DAYS AFTER THE VACCINE- NOT SURE IF THIS IS RELATED TO THE VACCINE --

Emesis, swollen left injection site, altered mental status Unknown if related to vaccine per hospital record IV Rochephen and IV fluids

Resident c/o itchiness & pain in R upper arm where injection site was located, about 48 hrs after injection. Noted 12cm x 6 cm swelling, redness at injection site. MD aware.. Ice pack given for relief and effective.

Immediately post COVID vaccination to left deltoid site developed bleeding and noted a 5.5 cm hematoma. Guaze wrap and ice pack applied. Patient denied discomfort. Observed for 10 minutes and no other adverse effects noted. Patient instructed to monitor for worsening of hematoma. Notify provider of any concerns.

A rash appeared more intensely at injection site but all over limbs and body. Went to general practioner who administered cetirizine 10mg 1x/day montelukast 10 mg 1x/day rash is drying and not as bright currently

Outbreak of rash all over body, causing rough, flaky skin; itchy, burning eyes. Neither antihistimine tablets nor eye drops provided any relief.

Day After - severe headache, 2 days after headache continues, itchy scalp, day 3 rash visible at hair line headache continues, more confusion than normal, day 4 on site nurses check rash and think it is dermatitis, day 5 continues to get work nurse practitioner was to visit next day, day 6 NP thinks that she has UTI and sends her to hospital (2/11/21). Hospital determines - Rash is Shingles, UTI present, - MRSA is now present in shingles which is on right back of head and right neck and face. Next Sepsis is diagnosed. Since 2/11/21 patient was not conscious. 2/20/21 famiy is notified that she should be moved to Hospice. Moved to hospice on 2/20/21. The patient, my mother, died on 2/23/21 official cause of death is UTI.

3/6/2021 Expired at facility receiving Hospice Services since 8/1/2020. Hx Covid-19 June 2020. Prior to death: Resident began refusing meals and failing overall. On, 2/18 began with jaundiced skin, no other symptoms. ADPOA, Hospice APRN and MD updated. Comfort measures maintained as resident continued to have slow decline.

Hives began at injection site (raised, red rash); spread to back - initially looking like pimples but when spread resembled site reaction. Now hives are on buttocks, legs, arms/hands; and scalp. Saw doctor yesterday (3/10/21). Prescribed Zyrtec and Pepcid. So far no relief.

Approximately 48 hours after receiving 2nd dose of the vaccine, vaccine site became swollen, red and hot. Also the outside of the bicep was also swollen. Symptoms lasted for a coupled of days.

When she got the first dose it hurt a little, but didn't hardly feel anything.; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot: Either EX3246 or EL3246) via an unspecified route of administration left arm, at the age of 90-year-old, on 07Jan2021 around 13:30-14:00, single dose, for covid-19 immunisation. Medical history included glaucoma and drip down her nose and sinus. The patient's concomitant medications were not reported. In Jan2021, when she got the first dose, it hurt a little but didn't hardly feel anything. Outcome of the event was unknown.

Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: Coroners Office contacted Pharmacy on 3/21/21 to report a patient who had recieved a dose of the covid vaccine on 3/18/21 and was founded deceased on 3/20/2021

Approximately 2 days after receiving her vaccine, she began to develop swelling and tender spots on both legs, mostly around the knees. These spots continued to grow in size, swelling and got more red in color. She developed more around the ankles. Edema of both legs worsened. approximately 20 days after receiving the vaccination she developed a similar spot over the right thumb. She also complained of scratchy throat, especially when lying down at night although she is noted to have chronic allergies. On March 25, she was re-evaluated. Given that her symptoms were worsening, and lab tests were abnormal she was treated with prednisone.

itching between elbow and shoulder, near the injection site and all around that area/had Itching and bothered where the needle went in and now is red and irritated; had Itching and bothered where the needle went in and now is red and irritated; a little red rash from where it was injected; where the needle went in it was irritated/had Itching and bothered where the needle went in and now is red and irritated; This is a spontaneous report from a contactable female consumer (patient herself) of 90-years-old received second dose of bnt162b2 (BNT162B2 Pfizer-Biontech covid-19 vaccine, Formulation: Solution for injection, Lot number and Expiry date were not reported) via an unspecified route of administration on 28Jan2021 Thursday in right arm and first dose (Lot number: Either EX3246 or EL3246) via an unspecified route of administration in left arm on 07Jan2021 around 13:30 to 14:00 both as single dose for covid-19 immunisation. Medical history includes glaucoma in her eyes, has drip down her nose, sinus, flu shot and includes she got irritated in the area for a day or two whenever the flu shot taken. No family history was reported. The patient's concomitant medications were not reported. Prior to the vaccination, the patient had not received any other vaccine within 4 weeks. On 28Jan2021, the patient experienced irritation and had itching, redness and rash where the needle went in. And later itches between elbow and shoulder in the area where the vaccine went in and around back and front. Patient's lab tests were not reported. No therapeutic measures were taken. The caller asked if the itching was normal and asked what to. The outcome of the events was unknown. Information about Batch/Lot number has been requested.

Stroke. ER treatment. Hospitalization. Skilled Nursing Facility. Symptoms: Weakness/fell to the floor/terrible bruises entire left side of body/slurred speech/confusion. Treatment: TPA administered. Hospitalized for 10 days, followed by continuing stay in skilled nursing facility.

02/21/21- Resident has been refusing meds and meal with continued poor PO nutritional intake, and lethargic. She continue to have periods of medication refusal and continued poor PO intake. 3/8 She developed shingles to her R buttock and was started on Acyclovir cream x7 days. She continues to decline medically. Admitted to Hospice on 3/12, poor PO intake and weight loss. 3/23 Resident passed.

Rash on lower torso, right side from lower back around the side to the front Saw primary care doctor on Wed. 04/14 who diagnosed shingles and prescribed valacyclovir HCL. At this time patient is taking the valacyclovir and the condition is healing.

We received a phone call with very minimal information that the person who received the second Pfizer vaccine developed a case of Shingles the following day, and was seen by her physician and at Urgent care. Symptoms started 18 hrs post 2nd dose. Started approx. size of a quarter on right side chest/breast, and spread to arm pit and arm. 10 days post incident she is recovering

It started with swelling, redness, and heat at injection site pretty soon after the injection on Friday 5/21. By Sunday, 5/23, patient had instability when standing and walking; her dementia had gotten worse; there was edema in her whole right arm; and she started having tremors. She was brought to Hospital by ambulance that afternoon and has since had decreased appetite and thirst; continuing swelling at injection site and in her whole right arm; terrible tremors; very low oxygen levels; and is almost comatose. The doctors there have said her kidney function has dropped to unacceptable levels and they are also monitoring her heart. She has been put on hospice care as of this time, 5/26.

Dehydrated; Lost her electrolytes; Her lips were cracked; Eczema; exhausted and she couldn't leave the bed; Hallucinating; Violent dreams; Strange aches in one of her arms and one ear; Strange aches in one of her arms and one ear; Has not had the same energy; This is a spontaneous report from a contactable consumer (patient). A 90-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Feb2021 (Batch/Lot Number: EL9261; Expiration Date: May2021) at the age of 90-years-old as single dose for covid-19 immunization. Medical history included allergies to Shellfish, penicillin, sulfa, mercury, and latex, the patient has been tested positive on 08Jan2021 for covid-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot Number: EL9261; Expiration Date: May2021) on 26Jan2021 at the age of 90-years-old for covid-19 immunization and experienced exhausted, weak, so lethargic she could barely move, had chills, and she lost her sense of taste. For second dose: Most of these symptoms began on 16Feb2021 around 6:00 - 7:00 pm. The patient was exhausted and she couldn't leave the bed, started 16Feb2021, improved. The patient was hallucinating, started 16Feb2021, improved. The patient had chills, started 16Feb2021, improved. On an unknown date in Feb2021, the patient was dehydrated to the point to where her lips were cracked, the patient was so dehydrated and couldn't get enough water she drank so much water that she lost her electrolytes which was why she was hospitalized. The patient was hospitalized on 28Feb2021 and released on 01Mar2021, they gave her an IV for treatment. The patient had violent dreams, started 16Feb2021, improved. The patient had strange aches in one of her arms and one ear, started 16Feb2021, improved. The patient has not had the same energy since the shots on 16Feb2021, she's going to physical therapy for this. The patient had eczema, started 28Feb2021, ongoing. The outcome of the events eczema was not recovered, the outcome of the event dehydrated, lost her electrolytes and lips were cracked and 'has not had the same energy' was unknown, the outcome of the other events Hallucinating, Violent dreams, 'Strange aches in one of her arms and one ear', 'exhausted and she couldn't leave the bed' was recovering.

Blisters (size of a quarter) keep breaking out on legs. A lot of them break out repeatedly in the same spot. They are painful and she feels fatigue with them. She has been given a topical cream. (Fluorouracil) The cream does not seem to do anything. She has been to the hospital, primary doctor and dermatologist. Blisters continue to break out everyday. In addition, she was diagnosed with Macular Degeneration in her right eye.

She got her 2nd vaccine, and almost immediately into her shoulder had pain in her shoulder blade and into her neck and had a lymph node on the right side of her chin/upper neck, then she has another one that is smaller and back further, and possibly a third one that is almost to the right side of her neck, tiny in nature. None on the left side at all. She felt that they would eventually go away and didn't do anything about it. She went to see her Dr., and he did a neck scan on 4/7/21, and reported that it was not cancer and told her to watch it, but if they were there in 4 months that they would have to be removed, they are still there. They have not changed in size. She has not gotten any more either. She definitely can feel the two and the third one is there but tiny. Her arm is still very sore at the site of the shot at the muscle. Almost daily at the site it gets very very sore and she gets chills and has to lie down due to exhaustion that lasts about 40 minutes and has to go lay down and then she gets back up once the chills pass. She was having it every day at noon almost every day, and still continues pretty much on a daily basis, but the arm is still very sore.

Constant burning, throbbing pain in R calf unrelieved by acetaminophen or naproxen; different from arthritis in her knee.

allergic reaction rash really bad on her back, arms and neck, legs little bit on her chest; This is a spontaneous report received from a contactable consumer, the patient. A 90-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 0878346) via an unspecified route of administration in left arm on 06Mar2021 at 12:15 (at the age of 90-year-old), as a single dose, for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), atrial fibrillation and allergy to influenza vaccine. The patient previously received Influenza vaccine on an unknown date. The patient had received unspecified prescribed medications withing two weeks of 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. The patient did not receive any other vaccine 4 weeks prior to COVID vaccine. On 09Mar2021 at 01:00, the patient experienced allergic rash on back, arm, neck and chest, which was really bad. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of allergic rash and included treatment with cream and pills (unspecified) from an unknown date. The clinical outcome of event allergic rash was resolving at the time of this report. No follow-up attempts are needed. No further information is expected

Shingles; First dose on 23Mar2021 and the second dose on 22Jun2021; This is a spontaneous report from a contactable consumer (the patient). A 90-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Jun2021 (at the age of 90-years-old) as a single dose COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Mar2021 for COVID-19 immunisation and Shingrix vaccine on 13May2021 for immunisation and experienced shingles on 01Jun2021 with both of the vaccines. It was reported that the patient received first dose on 23Mar2021 and the second dose on 22Jun2021 (inappropriate schedule of vaccine administered). On 22Jul2021, the patient experienced shingles. It was reported that that in between the two doses she had to fit her number two shingle, Shingrix inoculation. She stated that she got the shingrix vaccine on 13May2021. The pharmacist told her that would be a safe date away from 23Mar2021 for the first Pfizer dose and her new date for the second dose was postponed till 22Jun2021. She stated that something went wrong, terribly wrong. She stated that this was the second attack of shingles that she has had in between 01Jun2021 was number one and yesterday was number two. It was on her face, in the same place and same symptoms only this time it was spreading very fast and the medication she was on doesn't seem to be doing anything. She has been on the medication fully for 3 days now. She wanted information like what to do, she stated there was a bulletin on a news network that she listened to and it said that the Pfizer COVID-19 has an unusually of people calling in that they had developed shingles after they had their inoculations. Even though they had protection like me. She wanted to know if that was correct. Caller asked for a web address that her family can look up on the net so they can get further information for her. Something they can find out on their computer because she was not getting any information and her doctor was on vacation and she was suffering badly from a horrible outbreak all over her face and chest. She wanted more information on if this was going to be common because within six weeks she has had exactly the same outbreak, that was really bad she cant handle this and never had shingles in her life. She was very glad to get protection by shingrix, but evidently she didn't get protection for one reason or another. She wanted to know if her immune system compromised and She wanted to know why they referred her to Pfizer medical information because there was no information to give her. She cant find out anything. Therapeutic measures were taken as a result of shingles. The outcome of event shingles was unknown. The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.

shingles; This is a spontaneous report from a contactable consumer. This 90-year-old female consumer (patient). A 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Mar2021 as dose 1, single for COVID-19 immunization; varicella zoster vaccine rge (cho) (SHINGRIX), via an unspecified route of administration from 13May2021 (Batch/Lot number was not reported) to 13May2021, at dose 2, SINGLE for an unspecified indication. The patient's medical history and concomitant medications were not reported. Caller stated that she was a 90-year-old lady who received the two-dose series of the Pfizer COVID-19 vaccine. She stated that in between the two doses she had to fit her number two shingle, Shingrix inoculation. She stated that she got the shingrix vaccine on 13May2021. The patient reported that the pharmacist told her that would be a safe date away from 23Mar2021 for the first Pfizer dose and her new date for the second dose was postponed till 22Jun2021. The patient thought that would be enough time as well. She stated that something went wrong, terribly wrong. She stated that this was the second attack of shingles that she has had in-between 01Jun2021 was number one and that day (yesterday) was number two. It was on her face, in the same place and same symptoms only this time it was spreading very fast and the medication. The reporter wanted information on what to do, she stated there was a bulletin on a news network that she listened to and it said that the Pfizer COVID-19 had an unusually of people calling in that they had developed shingles after they had their inoculations. Even though they had protection like her. She wanted to know if that was correct. She stated she would love information because she was going crazy. Caller asked for a web address that her family can look up on the net so they can get further information for her. Something they could find out on their computer because she was not getting any information and her doctor was on vacation and she was suffering badly from a horrible outbreak all over her face and chest. She asked if that's the best they could do. Caller was referred back to her doctor or the doctor that was covering for her doctor while he was out of town. She stated that she had been getting help. she was just wondering and wanted more information on if this was going to be common because within six weeks, she has had exactly the same outbreak within six weeks. Treatment medication was received for the event shingles (she had been on the medication fully for 3 days then). Outcome of the event was reported as unknown at this time of the report. Information on lot/batch number has been requested.

Less than 30 minutes after receiving vaccine patient reported some itchiness on right arm as well as some light-headedness and an "odd" feeling on her right side only. Blood pressure was 126/68mmHg. Recommended water and some food if possible. Patient's symptoms resolved on their own after patient had lunch - did not report any new or worsening symptoms roughly an hour after vaccine administered. No medications were given to patient to treat symptoms.

Immediately, felt burning at injection site, then mild headache, lips tingling. . About 40 minutes later, lips and tongue swelling, and uncomfortable swallowing.

Pt. stated that she was told by nurse aid her face was red. Pt. stated she was feeling better. Pt. evaluated by paramedics. vss Pt. discharged home and advised to call 911 is symptoms worsened.

Saturday night (4:45) 1-23-21 - swollen right ear, itchy head and some welts on upper body Sunday morning (8am) 1-24-21 - face and eyes swollen, itchy and welts or rash all over upper body

On Feb 3 woke up very dizzy, lightheaded, arm pain. Feb 9th developed rash on both arms from elbows to hands, extremely itchy and also had a large blister develop on left arm.

hands are really itching, palm of hands itching, knee might itch a bit; This is a spontaneous report from a contactable consumer reporting for herself. A 91-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration (injection given in left arm) on 27Jan2021 11:00 at SINGLE DOSE for COVID-19 immunization. The patient has no medical history. The patient was taking unspecified concomitant medications (takes a lot of mediations but they are the same thing she has taken for a long time. Nothing was new). The patient experienced palm of hands itching, knee might itch a bit on 27Jan2021. Patient reported she walked outside for about a half an hour; she didn't have anything on her hands. However, when she came back inside, her hands were really itching, specifically the palm of her hands. She has never had this happen before. She came back inside and took her mask and coat off and when she started to get warm, her hands started itching. She stated it's like the cold caused the itching or something. The itching has stayed the same. It was just itchy. She stated her knee might itch a bit, but her hands are really itching. She was not given her vaccine record card. Her facility is saving it and will give it to her after her second vaccine. No investigation assessment reported. Event outcome was not recovered. Information on Lot/batch number has been requested.

she couldn't urine/She couldn't urinate anymore; she couldn't urine, patient tried for a long time in the bathroom and only got a few drops of urine out; Always had burning on bottom of her foot/she felt like her body was burning up in side/Felt like she was burning alive; Had a fever every day and every night/Temperature was 100 degrees; she has an infection in her bladder; feel like I am dying/had a very strange feeling in her body/Something was going across the top and right side like a fluid was flowing or something strange; sweating/wet, perspiring all night./Got all wet with perspiration; gotten more sick; weak; tired; headache; lost a little weight; Eats very little now; afraid; pain was around the bottom of the foot now it's on top of the foot and goes up to knee; uncomfortable; sneezes; diarrhea; cramps; constipation; colon cancer; doesn't think the needle went in all of the way when the nurse administered her vaccine; shingles; Post herpetic neuralgia/the post-herpetic neuralgia was on her whole foot; pain at the bottom of my foot; impact on the nervous system; This is a spontaneous report from a contactable consumer (patient). This 91-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EN5318), via an unspecified route of administration on 02Feb2021 at single dose in the left arm for COVID-19 immunization. The patient medical history included high blood pressure, kidney cancer, cancer in her bladder 20 years ago and coughing. The patient's concomitant medications included ergocalciferol (VIT D), ascorbic acid (VIT C), losartan potassium for blood pressure, metoprolol succinate for blood pressure, amlodipine for blood pressure, acetylsalicylic acid (ASPIRIN 81). Patient had cancer in her bladder 20 years ago. That was taken care of. Had kidney cancer because her husband used to smoke and blow it in her face. Had rare type of kidney cancer. It was removed. Treated for bladder cancer. Patient has had no problem ever since and that was more than 18 years ago. Patient had a fever, headache, and was very tired. Burning up on side of the body and she got all wet. This was not normal and she felt like she was dying. Patient stated she had shingles and developed post herpetic neuralgia. Patient always had pain at the bottom of her foot but it was getting worse after she received the first dose of Pfizer COVID-19 vaccine. Patient noticed the liquid going thru arm to chest and in straight line to her leg, like a science fiction movie with an injection of some kind. The doctor thought the vaccine might have an impact on the nervous system and spike the symptoms of post herpetic neuralgia. Patient spoke to her doctor but nobody knows anything. Nobody was willing to help her. Patient felt like she was dying. She didn't want to die. Patient feel the symptoms are getting worst. She was burning up inside. Her pain was around the bottom of the foot now it's on top of the foot and goes up to knee. Patient was not blaming anybody but she thought it was the vaccine. Patient was sweating, wet, perspiring all night. The symptoms usually occur at night. Patient wanted to know if these symptoms were associated with the vaccine. Patient also mentioned she developed a bladder infection for which she was taking antibiotics. Patient had Pfizer vaccine on 02Feb2021, about 5 days ago. Patient followed instructions before vaccine. Doctor said to take paracetamol (TYLENOL) before the vaccine for a headache. Patient did that. Patient had injection and told to wait for 15 minutes before she went home. About 5 minutes, she was relaxed and sitting down. Vaccination given in left arm. All of a sudden she had a very strange feeling in her body on 02Feb2021. Something was going across the top and right side like a fluid was flowing or something strange. Then it felt like a straight line down her right foot and it stopped. Was a feeling like maybe the liquid of the vaccine went that way. Didn't have a vein going that way. Patient was afraid. She went home and didn't remember the next thing that happened. Every night she has gotten more sick. Patient had a feeling in her foot where she had shingles a few years ago. After shingles had post-herpetic neuralgia. Patient always had burning on bottom of her foot and would put it in ice water. Patient could handle that because it was just uncomfortable. After injection, she got so bad, the post-herpetic neuralgia was on her whole foot and it started to burn. It went up a little towards the knee or higher. Yesterday, at times, it quickly went over to the left leg. Patient had a fever every day and every night. Patient took paracetamol to cut the fever. Patient was coughing on call but stated that was nothing and the coughing was something she had. Every night she felt like her body was burning up in side. Felt like she was burning alive. Got all wet with perspiration. She changed clothes and every night it got worse. Patient called emergency, they listened to her, stating they have never heard of anything like this. Asked patient if she wanted to go to emergency. She stated ok. The doctor listened to her story and told her it was weird. Doctor told her to give it a few more days to up to eight days. Doctor wanted her to get a urine test, but she couldn't urine, patient tried for a long time in the bathroom and only got a few drops of urine out and it was brown. Not normal urine. Next day patient called 911. She wanted to be assured she was not dying at home. Did have room available at the hospital. Patient had to sit in a wheelchair and there was no bed for her to lie down in. Last time she was admitted from the emergency. Next day she came home and had to call emergency again. Really thought she was burning up. Patient didn't want to go to the hospital and suffered at home. Next night and third night was so bad. Patient couldn't urinate anymore. She had a fever, but not a high fever, because the paracetamol cut the fever. Temperature was 100 degrees. On the inside she thought she was being burned up a live. Never got better, always got worse. Yesterday, she was in the hospital all day. Now she has an infection in her bladder. Was put on a machine and everything. Had a long procedure, and got the urine going. Patient didn't miss not urinating. Has accidents like when she sneezes or cough. Usually gets up 2-3 times at night to urinate. When she finally realized she couldn't urinate, the doctor kept her there for a long time, eight hours. Was put on the machine, thought she may need a catheter. Her bladder was massaged in order to get her to urinate. Patient only had the left kidney. Correct problem about the urine. Doctor told her to make sure she goes back for second dose on 23Feb2021, but she was afraid. In the morning she was a little better, couldn't handle this. Patient was very weak and tired. One night she was in the emergency and didn't sleep because of the procedures. Patient didn't think the needle went in all of the way when the nurse administered her vaccine. Sensation started on the left, went across her chest, straight down like an arrow. Like something was trickling down to the end of her foot and stopped. Patient had symptoms every night since. So severe patient thought she was burning up. Patient got worse every night and didn't get any better. Patient said feeling at COVID-19 Vaccine injection site was not a natural thing. Last time she was in the hospital her blood pressure went up to 184. After COVID-19 Vaccine patient lost a little weight. Same time had this problem, was seeing a doctor with a colon specialty. Had so much constipation for a long time and tried to correct it with mediation. Medication was too strong and gave her diarrhea. Doctor thought maybe she had colon cancer. Stopped the medication. Wasn't 100% healthy, but that was just cramps. Patient eats very little now, not very hungry. Patient feels good in her bowels after something good from a restaurant. Patient attempted to clarify the medication that was too strong. She stated it was over the counter. She stated it was something that had to be mixed. She was supposed to take a cap full and mix it with 8 ounces of liquid. Needed something to make her have a bowel movement. Only took it for two days. Was way before the vaccine. It was too strong and she stopped it. Patient took a probiotic. After that patient was given gas relief medication called: Gas Relief Extra Strength Simethicone, 125mg. Provided: V11496, MSRS 53041 REV 0417, and 883928. Patient no longer has constipation. Now it is the opposite. Now bowel movements are soft and pasty. Patient tried a stool softener that didn't work, was worthless. Was over the counter. Patient didn't take stool softeners after the COVID-19 Vaccine. All the events started from Feb2021. Outcome of the events was unknown.

On 2/9/21 patient received her first vaccination in her right arm. She only had a mild headache that afternoon that Tylenol took care of. On 3/2/21, patient received her second vaccination in her right arm. That same afternoon she had a mild headache that Tylenol took care of. On the evening of 3/6 she noticed a slight itchiness on her arm near the injection site. She took 1 24hr Fexofenadine and rubbed 1% hydrocortisone on the affected area. The following day, on 3/7 she noticed the swelling spread and the itchiness was worse and she took another Fexofenadine and used the 1% Hydrocortisone. As of today, 3/9 the itchiness is slightly better but the swelling & red area is still present.

Morning of 2/3/21 Pt woke up feeling lightheaded and dizzy. On 2/8/21 she developed a rash on both arms from the elbows down to the wrists which was extremely itchy and warm. There was also a large blister on her lower left arm. Her face was also red, very tight and warm! Took her to her general physician on 2/9/21 he had no idea of what was happening. Took her to dermatologist on 2/11/21 and she immediately sent her for an extensive bloodwork workup. The results of the bloodwork is bullous pemphigoid.

Very serious bacterial urinary tract infection; Rash; on face, underneath nose and underneath chin, aggravating rash; Bacterial infection; This is a spontaneous report from a contactable consumer (the patient). A 91-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 on 26Feb2021 (at the age of 91-years) as a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW), via an unspecified route of administration on unknown date as a single dose for COVID-19 immunization. The patient reported that she got her second COVID-19 vaccine Friday, and she has gotten a rash. It is just on her face, underneath her nose and underneath her chin. It is aggravating rash. She does not know what it is. She does not know what it could be or something else. The patient also reported "I had a very serious bacterial urinary tract infection, bacterial infection". The patient did not have any treatment for the rash. The clinical outcome of the events very serious bacterial urinary tract infection, Rash; on face, underneath nose and underneath chin, aggravating rash, and Bacterial infection was unknown.

hardness at injection site; has an area on her arm that is 3 inches in diameter that was red and swollen at the injection site.; has an area on her arm that is 3 inches in diameter that was red and swollen at the injection site; This is a spontaneous report from a contactable nurse reporting for her friend (patient). A 91-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration, administered in arm Right on 18Feb2021 14:00 at single dose for covid-19 immunisation. Medical history included stage 3 kidney disease, colon cancer, breast cancer and radiation from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced hardness at injection site and has an area on her arm that is 3 inches in diameter that was red and swollen at the injection site on 28Feb2021. The nurse reported that her friend got the first injection of the Covid-19 vaccine on 18Feb2021. She was fine and did not have any reactions. Yesterday she showed the nurse an area on her arm that was 3 inches in diameter that was red and swollen at the injection site. The nurse adds that she told her friend to apply ice to the area but she did not do that last night. Her friend said the area did not hurt. The nurse adds that it is strange that it appeared 10 days later. The patient did not recover from the events. Information about lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship and known product safety profile, causality between reported vaccination site reactions and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Blood sugar has gone up/Blood sugar started increasing; Burning in chest; Had trouble keeping head up; Nauseous; Pain between shoulder blades; Pain at injection site; Did not feel good; Heartburn; Bones hurt worse than usual; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269, Expiration Date: 31May2021) intramuscularly, administered in left arm on 12Feb2021 at 14:55 (at age of 91 years old) at a single dose for COVID-19 immunization. Medical history included type 2 diabetes (Diagnosed 15-16 years before this reporting), high blood pressure prior to that. She lost a lot of weight since she found out she was diabetic, which was prior to getting vaccine, around 15-16 years before this reporting. She lost 50 lbs in 15 years. It has been gradually. She gets Prolia shots and did not get one this month. She has scoliosis and osteoporosis and that was one of the things that happened. She had previously broken her shoulder blade and some ribs on her right side. She confirmed that she broke it over a year before this reporting. She has a yellow mark and a little reddish mark that looks like someone hit you. It is still there and it is a fading black and blue mark and does not hurt any more. She takes blood pressure medicine. She does not take diabetic medication. She did in the past, but it caused her ankles to swell and then she started controlling it with diet. She was right handed and had trouble trying to do things with her left hand. This started prior to the vaccine. Family medical history included: Family heart issues and diabetes. Heart disease and cancer in the family. There were no concomitant medications. The patient previously took Prolia for back problems. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9261, Expiration Date: 31May2021) on 22Jan2021 at age of 91 years old at a single dose for COVID-19 immunization. She didn't have any problems after the first COVID-19 Vaccine. No additional Vaccines administered on same date of the Pfizer Suspect. The patient experienced blood sugar has gone up/blood sugar started increasing on 15Feb2021 at 08:00, pain at injection site on 12Feb2021 at 14:55, pain between shoulder blades on 12Feb2021 at 20:30 to 21:30, had trouble keeping head up on 13Feb2021 at 07:30, nauseous on 13Feb2021 at 07:30, burning in chest on 13Feb2021 at 08:30, did not feel good on 12Feb2021 at 08:30, heartburn on 12Feb2021 at 08:30, bones hurt worse than usual on 12Feb2021 at 07:30. She has stated her blood sugar has gone up since she's received the second dose of Pfizer's COVID vaccine on 12Feb2021. Blood sugar started increasing was reported as worsened. She was type 2 diabetic and does not take any medicine. She got second shot on 12Feb2021, and her sugar was 89, then she started not feeling good the day after. On 15Feb2021, she was checking it and it was 119. On 16Feb2021, it was 145. On 17Feb2021, it was 144, and 18Feb2021, it was 145. She had never had them this high. It does not mention it can do anything to your sugar. She does not know her height. Last she was measured was 4'6"-4'7". Her highest was 5 feet. This was prior to the vaccine. She said her weight was between 80-85 lbs. The second shot hurt when they gave it to her. About 6 hours later, it felt like she was hit by lightning between her shoulder blades. She had previously broken her shoulder blade and some ribs on her right side. That has been bothering her and it felt worse when she got the vaccine and she could hardly lift her head up. The pain went from her left shoulder blade to right shoulder blade and stopped right away and then it felt like a lightening thing. She had trouble keeping her head up. She still has trouble with shoulders and is putting heating pads on them. She felt nauseous off and on. Her bones usually hurt, but after the second injection they hurt worse. As long as she puts heat on them, it feels better. The second dose feel like it hit the bone. The first one did not feel that way. The outcome of the event "Blood sugar increased, Chest burning, Feeling abnormal, Heartburn, Bone pain" was not recovered, for events "Shoulder blade pain, Heaviness of head, Nauseous" was recovering, for event "Vaccination site pain" was unknown.

SYNCOPE, fall, head contusion FATIGUE DIARRHEA Pneumonia due to SARS-associated coronavirus Diverticulitis Hyponatremia Hypoxia Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (CMS/HCC)

blister on her arm/blisters on both arms, from elbows to hands, upper, forearm, face and neck; rash on both arms; It was a very itchy rash, kind of red and blotchy on both arms, forearms to fingers; It was a very itchy rash, kind of red and blotchy on both arms, forearms to fingers; It was a very itchy rash, kind of red and blotchy on both arms, forearms to fingers; arms were so inflamed and itchy; arms were so inflamed and itchy; felt light headed/Dizziness; This is a spontaneous report from a contactable consumer (patient's daughter). A 91-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration Date: unknown, NDC number: unknown), via an unspecified route of administration, administered in Arm Left on 01Feb2021 15:30 (at the age of 91-year-old) as single dose To protect from Covid virus. 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) was none. Illness/AE: None. Pertinent Details (include surgical procedures and dates): N/A. Family Medical History Relevant to AE(s): None. There were no concomitant medications. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional vaccines administered on same date of the Pfizer Suspect was none. On an unspecified date in Feb2021, the patient experienced Dizziness, Lightheadedness, broke out in a rash; very itchy rash, blisters on both arms, from elbows to hands, upper forearm, face and neck, red and blotchy on both arms, forearms to fingers, arms were so inflamed and itchy. The patient received the first dose of COVID-19 vaccine and developed a rash on both arms 6 days post vaccination. The reporter had noticed on day 8 (09Feb2021) a huge blister on her arm. She also felt light headed. The reporter thinks these side effects were related to the vaccine and wanted to know if they are reported with the vaccine. She also wanted to know whether the patient could get the second dose of the vaccine. It was reported that seems to be having a reaction to the first Pfizer Covid-19 shot. A couple days later, she had dizziness and lightheadedness and then days after, Day 6 (07Feb2021), that broke out in a rash. Yesterday, day 8 (09Feb2021), she had blisters on the arm and there is no other reason for her to have them, it wasn't like she did anything. Blisters are on both arms from elbows to hands. Had a little bit on the face and neck, none on her trunk, just on the upper forearm and hands. Is there anyone who has reported this reaction. Still had the rash and blisters, they had not changed. It was a very itchy rash, kind of red and blotchy on both arms, forearms to fingers. Had nothing where the injection was, it was just from the elbow down. Did go to the doctor yesterday (09Feb2021), for the rash and blisters and they had no idea what it was. Her arms were so inflamed and itchy they gave Methylprednisolone tablets to help. The patient did not visit Emergency Room, but visited Physician Office for dizziness, lightheadedness, rash, very itchy rash, blisters on both arms, from elbows to hands, upper, forearm, face and neck, red and blotchy on both arms, forearms to fingers, arms were so inflamed and itchy. No Investigation Assessment. No Relevant Tests. Outcome of the event felt lightheaded/dizziness was recovering and all other events were not recovered. Information on the lot/ batch number has been requested.

She got the first Covid-19 vaccine yesterday and the nurse that had to put it in her, she felt it and it hurt.; really aching there in her left arm and shoulder high up; this morning and last night and didn't sleep good at all; couldn't even take off her pajama top; really aching there in her left arm and shoulder high up; This is a spontaneous report from a contactable consumer (patient). A 91-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included history of atrial fibrillation real bad where her heart has leaky valves and takes a lot of medicines. The patient's concomitant medications included unspecified medications for atrial fibrillation which were considered as co suspects. Caller states she needs to know. She got the first Covid-19 vaccine yesterday (09Feb2021) and the nurse that had to put it in her, she felt it and it hurt. Her other friends said they couldn't tell they were getting a shot, but she did and it hurt. Where she went to get it was organized and wonderful and she got the shot about 12:00. Before it got to 6pm she was really aching there in her left arm and shoulder high up. Instead of a soreness she had pain. Had pain this morning and last night and didn't sleep good at all and couldn't even take off her pajama top. It was reported that she has history of atrial fibrillation real bad where her heart has leaky valves and takes a lot of medicines. She has some Tylenol in the house but does not know with her heart condition if it is alright to take the Tylenol for the pain or should she not take it. Has not taken any pain killers last night for fear of not knowing what it would do. The facility where she had the shot she was taken to since she does not drive and it was very well organized and all. Was very glad to get this vaccine and if people in the county can take it eventually it can be cured. Again, mentions having so many friends say they didn't have any problems and not to worry about getting the shot and she was filled with so much hope. The literature says you can have some joint pains and tiredness and her problem is wondering if she can take Tylenol to ease the pain. No further details provided. Outcome of the events was unknown. Information on the lot/batch number is requested.

shingles; This is a spontaneous report from a contactable Nurse (patient). A 91-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 intramuscular, administered in Deltoid Left on 28Jan2021 15:00 as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. On 30Jan2021, she began to see shingles starting under her breast, and it went into full blown shingles. She first noticed shingles barely under one breast, she noticed a little bit of a rash start and then it got worse and went all the way to her spine. It is kind of scabbing over now and she still has the deep pain. She did not have a problem with the itch, but she did have deep pain. She was not sure if it was coincidental. She was wondering if she should take the next shot. hcp gave her a medication, Valtrex, that he did not think would work since she was seen a week or two later after seeing the shingles and it should be taken when the shingles first starts. She took all of it. Patient does not think it was life threatening. she mentioned she had a problem with shakiness. Height was about 5'2", she shrunk. No prior vaccinations within 4 weeks and no AE prior vaccinations. The outcome of the event was recovering. Information on lot/ batch number has been requested.

she feels like she is another world and has to lay down frequently; she feels like she is another world and has to lay down frequently; She has been experiencing intermittent dizziness; she feels like everything is a blur; injection arm is "black and blue."; This is a spontaneous report from a contactable consumer (patient) reported that a 91-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration on 28Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She has been experiencing intermittent dizziness, she feels like everything is a blur, she feels like she is another world and has to lay down frequently, vaccination site bruising on an unspecified date. Her injection arm is "black and blue." She wants to know if this is normal after the vaccine, she states she is going to an eye doctor appointment tomorrow 20Mar2021. No PQC involved. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

92 year female admitted to hospital for fall on 5/24/2021. Unknown exposures in 14 days prior. Pfizer vaccine 2/25/2021 & 3/19/2021. PCR positive 5/24/2021. Transferred to hospice on 29th. Passed on 5/30/2021. Diagnosis at time of death: ARF on chronic with hypoxia, hematoma anterior chest wall left hip and upper thigh, suspected mild heart failure preserved ejection fraction, mechanical fall, delirium, bilateral PNA, pulmonary HTN, acute encephalopathy.

Severe Hypotension, Redness, Warmth and sensitivity all over skin surfaces, lack of responsiveness, low oxygen saturation.

redness at injection site on arm. following day, similar redness appeared on cheek under eye. two days later, redness has not resolved on arm

Patient presented to ED 2/6/21 with rash on abdomen/chest with pruritus for past 1 day. Denies nausea/vomiting, chest pain, dyspnea, dizziness, cough. Received COVID vaccine and also prescribed Bactrim on 2/4/21. Also presented with acute renal failure, hyponatremia. It is likely that all these events are due to Bactrim but we are reporting to VAERS given patient received vaccine at same time. Patient has been treated with hydration with normal saline, Solu-Medrol, Pepcid, and cetirizine, Calamine lotion, sodium chloride tablets. Symptoms of rash have improved and sodium is improving.

patient noted with red "rash" to forehead, check, nose area and chin, does not itch. No other symptoms. patient was unsure if this was there prior to getting injection. Noticed about 10 min into post injection waiting. given 1 tablet Fexofenadine and observed x 30 min. Redness lightened up but areas still noted. Daughter with patient and will notify PCP if not better or worsens.

the next night she had a rash on her arm. not bad but just obvious. no pain or itching. like the diameter of maybe a baseball

ER three times, was given was given steroids' and benadrly IV. resolved and then restarted, revisited the ER again Sunday morning and then Sunday night and was medicated with the same and given prescriptions for prednisone, hydroxyzine. states she is itching all over

injection site started itching; Strange area around injection site about size of silver dollar, red around outer rim and kind of orangeish colored in the middle; Strange area around injection site about size of silver dollar, red around outer rim and kind of orangeish colored in the middle; feel extremely unwell; feverish 97.5-97.6 degrees Fahrenheit; tired; This is a spontaneous report from a contactable consumer (patient). A 92-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (upper arm) on 20Jan2021 11:00 (at the age of 92years) at single dose for Covid-19 immunization. Medical history included breast cancer, second right breast lumpectomy related to breast cancer from 16Oct2020 to an unknown date, first right breast lumpectomy related to breast cancer on an unknown date (done about 3-4 years prior to second right breast lumpectomy related to breast cancer), on blood thinner, allergic to the statins and allergy to unknown product (She was once given something, some medication for her heart, but about 5- 6 weeks later she developed a reaction to it so she was taken off the medication but does not remember the name of the drug.) The patient would consider herself obese at this weight, but that is probably because she was always very thin historically; her doctor has never diagnosed her as being obese or advised her to lose weight. The patient's daughter had a very, very aggressive form of breast cancer-she is deceased 11 years. Patient's younger sister had breast cancer; there is a lot of breast cancer on her husband's side- his mother, sister, niece all had breast cancer, they have a big history of breast cancer; other types of cancer in patient's family include her mother who died of pancreatic cancer in her 80s; and her dad had prostate cancer but he was in his upper 80s; and patient's older sister died of leukemia. Concomitant medications included warfarin from an unspecified date at 5 mg (daily x 2 days/week) then 2.5 mg (daily x remaining 5 days/week) as blood thinner and metoprolol from an unspecified date at 25 mg, 2x/day (morning and evening) for an unspecified indication. The patient previously had Flu shot. The patient reported that she got on last Thursday (21Jan2021) the first dose of the Covid 19 vaccine at 11 o'clock. She did not feel anything wrong at the moment (also reported as she had no immediate reaction at all). A couple of days after (About maybe 2-3 days later sort of in the middle of the day, not the morning) she started to feel extremely unwell, feverish (although thermometer did not indicate any raise) tired and malaise she was really surprised because it occurred that long after administration. She took Tylenol and she was looking to know if this has been reported as a side effect of the vaccine and how to treat it. She was very concerned about it because she has never had an adverse event with any vaccine or inoculation before. She takes a yearly flu shot and never had any reaction. Feverish: She has taken her body temperature with her digital thermometer which does not show a fever, it shows like 97.5-97.6 degrees Fahrenheit so not a fever; but she feels feverish. On 26Jan2021 the injection site started itching and she looked at site which is way up high so she can't turn her neck that way; but found a strange area around the injection site that is about the size of a silver dollar, red around the outer rim and kind of orangeish colored in the middle. She has never had that occur before, and the skin in the middle of the area, the orangeish colored area has no pain. She reported that there was a mass of people at the location where she was administered the Pfizer COVID-19 Vaccine. There were hundreds of people there when she was for inoculation event so she is wondering if she could have picked up COVID while there. She called to ask about these events related to the product. She has no major allergies. The patient underwent lab tests and procedures on an unspecified date which included body temperature: 97.5-97.6-degree Fahrenheit. The outcome of events was unknown. Information on the lot/batch number has been requested.

5"X7" RED, SLIGHTLY RAISED CIRCLE TO LEFT OUTER ARM AT INJECTION SITE- REPORTED AS ITCHY AND SLIGHTLY WARM OBSERVED ON 3/12/2021

No illness or vaccines prior to the COVID-19 shot on February 13, 2021. Monday, February 22, 2021, around 4 p.m. experienced sharp pains that would come & go behind right ear/neck area Tuesday, February 23, pain continue to come & go behind right ear/neck area in late afternoon into evening; trouble sleeping Wednesday, February 24, still having pain behind right ear/neck in early a.m. Contacted Primary Care Physician in early a.m. and had office visit. Prescribed Cefdinir 300MG capsules (Antibiotic) and sent for X-ray - Xr C Spine Min+ 4 Vw at Imaging Services. X-ray showed arthritis and began taking prescription.

No illness or vaccines prior to the COVID-19 shot on February 13, 2021. Monday, February 22, 2021, around 4 p.m. experienced sharp pains that would come & go behind right ear/neck area Tuesday, February 23, pain continue to come & go behind right ear/neck area in late afternoon into evening; trouble sleeping Wednesday, February 24, still having pain behind right ear/neck in early a.m. Contacted Primary Care Physician, Dr. (Internal Medicine) in early a.m. and had office visit. Prescribed Cefdinir 300MG capsules (Antibiotic) and sent for X-ray - Xr C Spine Min+ 4 Vw. X-ray showed arthritis and began taking prescription. On Wednesday, February 24, As day progresses, pain is now continuous. Thursday, February 25, Pain is throughout the day behind right ear/neck area. Late afternoon into evening, a small amount of rash has now developed on back area and side area of neck. Lymph node is swollen on right side back of neck. More pain behind ear. Pain is more severe late into evening. Trouble sleeping. Took Cefdinir as prescribed. Friday, February 26, contacted Dr. due to small amount of rash appearing on right side of face, right shoulder blade, behind neck, behind ear, and into hairline along with continued pain. Dr. diagnosed shingles over the phone. He prescribed medication for shingles and pain. Antibiotics were no longer taken. Shingles - Valacyclovir 1gm tablets. Pain - Aceteminophen/COD #3 as needed. Pain is more severe. Pain radiating into right ear. Can't sleep. From February 26 to March 5 shingles medication was taken daily. Additional rash developed. Pain was more severe/continued and trouble sleeping. From February 26 to March 4 pain medication was taken on Tuesday, March 2 and Thursday, March 4. One pill only to assist with sleeping. Monday, March 1, reported situation to Pfizer over the phone. Information on when to discontinue shingles & pain medication was obtained from Pfizer, and doctor prior to receiving second shot on Wednesday, March 10, at 9:30 same location as first shot. Shingles medication was finished on Friday, March 5. Pain medication was stopped on Friday, March 5 until after second shot. Pain medication resumed on Friday, March 12 and continues only as needed. Normally just one pill. As of Tuesday, March 23, rash, pain, swollen lymph node seems to be starting to improve.

Patient developed L facial herpes zoster-- > was hospitalized 3/30/21-3/31/21 for some IV acyclovir-- > discharged on oral valacyclovir 1gm po daily to complete 10days total

Patient received vaccination with no immediate reaction. Approximately 3-5 minutes later after the patient was helped to the observation area, the patient told her son that she was very hot. Her head then slumped forward and she became unresponsive to verbal and physical stimulation. Patient also threw up while unresponsive. She almost fell out of her chair onto the floor, but was caught before hand. When patient became unresponsive, emergency medical services was contacted and a dose of epinephrine was going to be administered. The training EpiPen was used so a dose was not administered. Patient recovered within a couple of minutes and paramedics arrived to evaluate patient.

condition aggravavated; Breaking out in my auto-immune; since February and all through March until today has broken out into red welts; This is a spontaneous report from a contactable consumer. A 92-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in right arm on 21Feb2021 at 12:30 (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) as a single dose for covid-19 immunisation. First dose: Date: 24Jan2021; Lot Number: EL9261; Expiry Date: 31May2021; Anatomical Location: Right arm. Medical history included neuropathy in hands for 3 years at least , ongoing autoimmune disorder she was diagnosed with the auto-immune condition at least 5 years ago. Concomitant medications included quinapril (QUINAPRIL) taken for high blood pressure for at least 5 years; apixaban (ELIQUIS) taken for blood clots in lungs for at leat 5 years and ongoing; vitamin d3 (VITAMIN D3) for at least 5 years taken to keep bones in order and ongoing; prednisone (PREDNISONE) taken for autoimmune condition, for about 5 years, start and stop date were not reported and gabapentin for at least 5 years. The patient reported that she has been vaccinated with the Pfizer Covid-19 vaccine and that she has received both doses. Patient reported that she has the auto immune system and that since Feb2021 when she had her Covid-19 vaccine, she has been broken out. Patient reported that she wanted to know if there was a possible relation between getting the Covid-19 vaccine and breaking out in her auto-immune. Patient reported that the red welts have come out on different parts of her body since Feb2021. Patient reported that she has had the welts on her neck and on her face. Patient reported on 19Apr2021, she was breaking out in welts on her arms. Patient reported that she has had welts behind her legs and that the welts break out anywhere.Patient reported that the welts are just ongoing. Patient reported that the welts are breaking out the same as when they first started. The patient was not hospitalized for the events. The outcome of the welts was not recovered and remaining events was not reported. Follow-up attempts are completed. No further information is expected.

The patient is having a hard time hearing me, she is hard of hearing in one ear; the pain was radiating in her ear and behind there; Rash/She still has the rash all over/ rash is behind ear, all down the back side of her neck, side of the neck up to hairline/right side of face/collar bone and little on back; swelling in the lymph nodes behind her right ear; trouble sleeping; sharp pain that would come and go behind her right ear/Ear pain was reported as worsened.; pretty big blotches; arthritis; shingles; This is a spontaneous report from a contactable consumer (patient's son). A 92-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in left arm up at the top on 13Feb2021 at 10:00 or 10:15 (Lot Number: EN6200) (at age 92 years old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received shingles shot for immunization. The patient's son said that a week and a half after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, the patient developed shingles and severe pain. He wanted to know if his mother should still go ahead and receive the 2nd dose. If so, how long does she have to wait to receive it. He said his mother received the 1st dose on 13Feb2021, and was scheduled for the 2nd dose on 01Mar2021 or 10Mar2021. After the shot, a week and a half later (Feb2021), the patient got what the doctor thinks is shingles. The reporter and patient didn't know if she should get the second vaccine. The shot was not given by her doctor or at his office. The patient was healthy before and she's in quite a bit of pain, should she get the next shot because she's worried about it. The patient's second dose was scheduled already on 10Mar2021 but hasn't been able to get a hold of the place when calling them. The patient had the shot on 13Feb2021, on Monday 22Feb2021 the patient had sharp pain that would come and go behind her right ear. Patient stated she hates the pain. The patient had swelling in the lymph nodes behind her right ear a couple of days later. On 23Feb2021 the pain continued off and on behind the patient's right ear and she was having trouble sleeping. On 24Feb2021, the patient went to the doctor and he prescribed antibiotics because he wasn't sure that's what it was. There were no spots on the patient yet, the patient had more pain than before in the back, but she did not have a rash or swollen lymph nodes. The patient's lymph nodes were swollen in the back of her neck Thursday night (25Feb2021). The pain continued, it was more severe. The patient developed a rash on Thursday (25Feb2021). Friday the doctor prescribed the medicine for shingles. On 28Feb2021, the pain was radiating in her ear and behind there, you'll see her wince. The patient didn't get red blotches yet. Monday and Tuesday the pain was sharp, kind of sticks and then it was gone, it came and went, yesterday it was constant all day and Saturday it wasn't constant. Saturday the pain was constant. Thursday you could feel the knots in the lymph nodes, they have gone down some today. There is a little improvement in the patient's ear lymph node swelling. The patient has ear pain. The doctor looked in the patient's ear on Wednesday the 24th, the pain radiates, on the outside and the inside, it's just pain, shoots there and behind there. The pain has gotten worse over the week. The pain is intermittent, not constant and when it comes it's really sharp, she's had more over the weekend where its coming more often. The patient was having trouble sleeping starting Tuesday evening, it was fair but by Wednesday the trouble sleeping wasn't bad yet, the patient was still able to sleep, she has had to sleep sitting up, but by Wednesday, she hasn't been able to sleep well. The patient states that she has slept better now that she's on medication, last night was the first time she slept well. The shot was given in the left arm, all of this is on the right side. The patient has had no vaccines before, she wasn't sick before this. She still has the rash all over, the rash is behind the patient's ear, all down the back side of her neck, side of the neck, up into her hairline slightly, on the right side of her face, on her collar bone, and a little on her back. People say they got a bad case. No further clarification provided. Reports these are pretty big blotches (Feb2021). The rash was about the same, between Thursday, Friday and Saturday the patient developed more of them. With the rash, the reporter noticed more on Friday and Saturday. Today the rash is there but it has not changed. For her history, the reporter stated she's on normal medication, she didn't have anything before this. The patient is not in a nursing home, resides in her own home, not in a facility, she's is able bodied to stay at home. The patient is mentally alert, walks with a cane when needed, she does everything on her own. The patient's doctor sent her for x-rays behind her right ear and face, facial, shoulder, and behind the ear area, behind the neck area on 24Feb2021. The patient's doctor's office called and said it showed arthritis. The reporter states that this pain is not from the arthritis. The caller mentions that the patient got a shingles shot, it was a one-time shot, and she did not have a reaction to it. The patient was having a hard time hearing, she is hard of hearing in one ear. The patient was recovering from trouble sleeping and swelling in the lymph nodes behind her right ear; not recovered ear pain and rash; while unknown for the rest of the events.

Reddness at injection site from shoulder and down to elbow.; Itchy; Periodically painful; This is a spontaneous report from a contactable consumer, the patient. A 92-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration, on 13Mar2021, (at the age of 92-years-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer and lumpectomy. The patient was allergic to codeine and penicillin. Concomitant medications included levothyroxine (SYNTHROID), calcium carbonate (CALTRATE), biotin (MANUFACTURER UNKNOWN), vit D (MANUFACTURER UNKNOWN), fibre (MANUFACTURERE UNKNOWN), docusate (COLASA) for unknown indication. 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 20Mar2021, the patient experienced redness at injection site from shoulder and down to elbow, itchy and periodically painful. A polysporin ointment on arm was taken as therapeutic measure for event redness at injection site from shoulder and down to elbow, itchy and periodically painful. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of redness at injection site from shoulder and down to elbow, itchy and period painful were not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Rash around injection site. Small red, chicken pox like areas scattered on left arm, left side of neck, and breast. Some complaints of itching. Hydrocortisone cream was ordered. Resident states it is no longer itching. Area seems to be resolving.

scabies; itching; rash neck to waist down/she developed a rash on her back; This is a spontaneous report from a contactable consumer (patient). A 93-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. Medical history included pacemaker. The patient's concomitant medications were not reported. She received the COVID vaccine on 29Dec2020 and 10 days later she developed a rash neck to waist down, she is in the nursing home and they are not sure if its scabies, she said the itching has lessened. She is in the nursing home for follow up for her pacemaker. caller wanted to know if there are reports of rash. Patient wanted to know about partial immunity (immunity after the first dose) and how long it takes to build it. Reporter wanted to find out if anyone reported a skin rash after having the Covid shot. Stated that her rash started 10 days later on her back and it looked like scabies. Stated that it will be treated as scabies. Stated the she did a report about the above mentioned previously. Stated that she is going to see her doctor later on today. It was also reported that she had the COVID vaccine 29Dec2020 and 10 days later on 07Jan2021, she developed a rash on her back and she was wondering if this was normal. It was confirmed that the patient was given the Pfizer BioNtech COVID-19 vaccine on 29Dec2020 and then developed a rash on her back 07Jan2021. She was asking if this was from the shot? Is the rash something that has been reported before? How long until she has some sort of immunity after getting first vaccine? She was not sure it is a side effect for sure. The aid at the nursing home thought it was scabies. But the patient has not been in contact with anyone with scabies, and has a clean bed and everything. The outcome of the event 'itching' was recovering while unknown for the other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

May be allergic to the latex from the bandage that they put on her afterwards- she left the bandage on afterwards and it started to itch; This is a spontaneous report from a contactable consumer (patient). A 93-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 11Jan2021 at site of left arm at single dose for COVID-19 immunzation. Medical history included allergic to the latex. The patient's concomitant medications were not reported. The patient left the bandage on afterwards and it started to itch on 11Jan2021, it may be allergic to the latex from the bandage that they put on her afterwards. She knew she was allergic to the latex, but she forgot to put that on her paper before getting the shot. Other than that, she was fine. The patient put some hydrocortisone cream on it to make it stop itching. The outcome of event was recovered on 11Jan2021.

Chief complaint: redness on skin; redness right eye first, then left Patient informed immunizer on the second dose date; per nurse. MD checked out with no problem/concern in the eyes.

During injection she felt it burning; Her Blood Pressure went up to 255; She felt weakness and Nausea; Became unaware of her surroundings.

headache; pain in arm; Aches/pain; Pain injection site; feeling like her whole body is burning up, hot feeling; could not sleep all night/did not sleep last night; tired; feeling like she has a fever/felt warm and feverish/temperature it was 98; chills; This is a spontaneous report from a contactable consumer (patient). A 93-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283) intramuscular injection in right upper arm, near her shoulder on 21Jan2021 10:00 AM at single dose for preventative. Medical history and concomitant medication were none. patient reported side effects to the pfizer vaccine after the first dose last Thursday 21Jan2021. Caller reported headache, chills, pain in arm and feeling like she has a fever. Caller stated pfizer should have two dose, one for small people and one for large people. Reporter asked what the timing of the second dose of Pfizer-BioNTech COVID-19 vaccine is and if she could receive it earlier or later than 3 weeks. Caller stated she received the first Pfizer dose on 21Jan2021 and her second dose is on 18Feb2021. She is calling about the Pfizer BioNtech Covid vaccine. She had the vaccine last Thursday on 21Jan2021. She started having the usual aches, headaches, and pain. On Saturday (23Jan2021) she started getting chills and by the evening she felt warm and feverish, when she checked her temperature it was 98. Last night, she felt like her body was burning up but her temperature was 98. She felt miserable and could not sleep all night. States she attributed it to the vaccine since she was feeling ok prior to the vaccine. She is asking if she should get the second dose. Weight: 95 to 98 pounds, she suggests that those that are smaller like her be given a smaller dose since she weighs so little. She is nervous about getting the second dose which is scheduled on 18Feb2021. She felt like she was burning up and it drained her. She keeps taking her temperature but she does not have a fever. She did not sleep last night. She feels better today. She is aching a bit today but not as much as she did. She is tired since she did not sleep last night. She still has the chills. States it is weird since she feels like she has a high temperature but does not have a high temperature or fever. She hears that there is usually not side effects with the first injection and usually there are side effects with the second injection. She did not feel the vaccine when it was administered. Her chills on Sunday was really bad and today it is better. The burning up/ hot feeling started gradually on Saturday and then on Sunday it got worse. She does not feel as hot and it has improved right now. it was also reported pain in injection site. Relevant Tests was none. no AEs following prior vaccinations. The last outcome of did not sleep last night and tired was unknown, of the events was recovering. It was a non-serious report. Event were not required a visit to Emergency Room nor Physician Office.

Right sided facial swelling that extends from Jawline into neck. Also noted with redness to facial area. Onset 2/10/21 with worsening today 2/11/21

Likely vaginal bleeding first noticed from stain on bed pad on 4/21/2021 and blood drops on toilet seat. Seen again a week later. Also apparent bruises to hand and wrist of unknown origin.

breathing needs oxygen now; rash on legs; fever; This is a spontaneous report from a contactable consumer (patient). A 93-year-old non-pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269, expiration date not provided), via an unspecified route of administration in arm left on 08Feb2021 at 04:00 (age at vaccination 93-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient received facility type vaccine in the Hospital. The patient was not pregnant at the time of vaccination. The medical history included high blood pressure and she had an open-heart surgery. The patient had COVID prior to vaccination. The concomitant medication included amlodipine, pantoprazole, clopidogrel and atorvastatin. Patient did not receive other vaccine in four weeks of vaccination. The patient stated the other medications received in two weeks included amlodipine, pantoprazole, clopidogrel and atorvastatin. The COVID was not tested post vaccination. On 12Feb2021, patient's breathing needs oxygen now, rash on legs and fever. It was unknown if the patient received any treatment. The outcome of events was not recovered. The explicit consent was obtained as yes. Follow-up attempts completed. No further information expected.

Itching at the site of the injection, periodically, particularly at night. Skin thickened at the site of injection.

they were told they were getting the Moderna vaccination but she was given the paperwork for the Pfizer Covid 19 vaccine; sore arm/arm is continuing to hurt and her lump is bigger and now it's getting red; increased redness at the injection site; The pain is also described as hurting up into the shoulder; arm is continuing to hurt and her lump is bigger and now it's getting red; arm is getting redder and larger and it hurts up into her shoulder and down to her elbow; arm is getting redder and larger and it hurts up into her shoulder and down to her elbow; mother has back problem and she is having back pain now too; This is a spontaneous report from a contactable consumer (Patients daughter) reporting for her mother. A 93-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 22Mar2021 11:30 (at the age of 93 years) as dose 1, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, at dose number unknown, single for an unspecified indication. Medical history included dementia (Verbatim: dementia), myocardial infarction (Verbatim: 4 heart attacks), stroke (Verbatim: 4 strokes), angioplasty (Verbatim: 9 angioplasties), angiogram (Verbatim: reaction to the dye when she gets the angiograms), mother has back problem, thyroid. On an unspecified date concomitant medication(s) included ongoing warfarin (WARFARIN); unspecified thyroid medication(0.075mg) she doesn't think her mother needs her thyroid medication anymore, but the caller needs her thyroid medication because she doesn't have a thyroid. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced they were told they were getting the moderna vaccination but she was given the paperwork for the pfizer covid 19 vaccine, sore arm/arm is continuing to hurt and her lump is bigger and now it's getting red and ongoing, increased redness at the injection site, the pain is also described as hurting up into the shoulder and ongoing, arm is continuing to hurt and her lump is bigger and now it's getting red, arm is getting redder and larger and it hurts up into her shoulder and down to her elbow, mother has back problem and she is having back pain now too. Reporter stated, she wanted to know if her mother should take the second dose of the Pfizer COVID-19 vaccine since she has had these side effects after receiving the first dose, she should use hot or cold packs to help her mother's arm pain from the Pfizer COVID-19 vaccine injection, how long she can expect her mother's side effects to last after receiving the first dose of the Pfizer COVID-19 vaccine. She states it's difficult to determine exactly how painful her mother's arm is because of her limited cognition and ability to describe the pain, also states that at times the mother will refuse to use her arm and other times she will use it as if there is no problem. Her mother does have a pacemaker and defibrillator and the facility was advised of that before her mother had the Covid 19 vaccine. She reports that they were told they were getting the Moderna vaccination but she was given the paperwork for the Pfizer Covid 19 vaccine. She's assuming since she had received the Pfizer paperwork that she and her mother had received the Pfizer Covid vaccine. Patient asking why her arm is sore and with her age and her dementia a few years ago her mother wouldn't have been complaining. She would have been different. She would have thought that her arm soreness was just part of the vaccine. Now reporter is concerned. She just wanted to call and check because her mother keeps holding her arm. Yesterday she put ice on it and she doesn't know if she should have done that. The caller reports she tries not to take her mother out because of Covid 19. She does go to the heart doctor because she's on the blood thinners and has the pace maker and defibrillator. Her mother has a tendency to get any infection easier now. Patient acts like a child sometimes in showing her arm and complaining about it. Daughter doesn't remember when her mother's arm started hurting. She remembers her mom saying there was a lump in her arm and the felt her own arm and felt a little lump in her arm too. Patient had open heart surgery also and the doctor went in and put a clamp on her leaking valve in her heart. She did have a reaction to an antibiotic during that time. reporter doesn't recall the name of the antibiotic. She reports it was done intravenously and her mother came out red as a beet, reporter states because of the Covid 19 you have to be in bad shape to go to the emergency room. The outcome of event arm is continuing to hurt and her lump is bigger and now it's getting red, arm is getting redder and larger and it hurts up into her shoulder and down to her elbow was not recovered rest of all event outcome was unknown. Description of complaint: Caller reports her mother is on Warfarin and occasionally the doctor has to change it up a little bit. The warfarin is in a pharmacy bottle. TARO is the manufacturer. Caller does not see an NDC/Lot/Expiry. No follow-up attempts are possible. Information on lot/batch number cannot be obtained.

Possible cellulitis; slight redness in left upper within 24 hours; severe redness and swelling and warmth of entire upper left arm and half of lower arm; severe redness and swelling and warmth of entire upper left arm and half of lower arm; Some pain; This is a spontaneous report from a contactable Physician. A 94-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140) on 30Dec2020 at 12.00 pm at single dose Intramuscular on left arm for COVID-19 immunization. Relevant medical history included COVID 19 infection, on 19Jul2020, post COVID left femoral DVT oral anticoagulation, Alzheimer dementia, Osteoarthritis, Spinal Stenosis, Gait Dysfunction and Constipation. Known allergies included acetazolamide, penicillin and sulfa. Concomitant medications included apixban (ELIQUIS ) 5 mg twice a day, colecalciferol (VIT D3) 1000u once a day. On 31Dec2020 at 12:00 pm patient experienced slight redness in left upper within 24 hours. The patient also experienced possible cellulitis, severe redness and swelling and warmth of entire upper left arm and half of lower arm. Some pain. No fever. It was also informed that patient underwent nasal Swab test for Coronavirus (Abbott BinaxNOW) on 05Jan2021 and on 07Jan2021 and resulted negative, for both. Treatment received for cellulitis included Cefuroxime. Outcome for the event possible cellulitis was unknown. Outcome of other reported events was recovering.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported events due to temporal association. However patient old age and other underlying conditions cannot be excluded for a contributory role 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.

Site: Pain at Injection Site-Medium, Systemic: Generalized Body Aches -Severe, Systemic: Headache-Severe, Systemic: Severe drop in blood pressure, pulse, and o-sat-Severe

soreness in her arm at the injection site in the left arm; bruising at injection site; injection site that is red and hot; itching and redness at injection site; itching and redness at injection site; This is a spontaneous report from a contactable consumer (patient). A 94-year-old female patient received BNT162B2 (Lot/batch number and expiry date unknown), via an unspecified route of administration from 30Dec2020 to 30Dec2020 at SINGLE DOSE in the left arm for COVID-19 immunization. There were no medical history and concomitant medications. The patient stated that she got the Covid vaccine a week ago on Wednesday, 30Dec2020, 9 days ago, stated she did not seem to have any problems or side effects after, then she felt some soreness in her arm at the injection site in the left arm. States that last night on 07Jan2021, she woke up itching and redness at injection site and when she looked at her arm this morning, there is a really bad 2 1/2 to 3 inches at the injection site that is red and hot. Also she experienced bruising at injection site. She wants to know if this is a common thing. The outcome of the event "bruising at injection site" was recovering; for events Vaccination site pruritus and Vaccination site erythema was recovered on unknown dates; while unknown for the other events. Information on the lot/batch number has been requested.

Disoriented; Urinary tract infection; Shingles/rash; Complaining of pain and burning; Complaining of pain and burning; she was not feeling that well; lose her mental faculties; This is a spontaneous report from a contactable pharmacist. A 94-year-old female patient (reporter's mother) receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 07Jan2021 (around 3:15 PM to 3:20 PM) at 0.3 mL, single (0.3ml dose injection in right arm) for COVID-19 immunization. Medical history included blood pressure, cholesterol, blood thinner and fluid. The patient historical vaccine included varicella zoster vaccine live (ZOSTAVAX) for immunization. There was no history of all previous immunization with the Pfizer vaccine considered as suspect as this was the first dose. The patient had no prior Vaccinations within 4 weeks. Concomitant medications included ongoing apixaban (ELIQUIS) for blood thinner, ongoing furosemide (LASIX) for fluid, valsartan for blood pressure, ongoing pravastatin for cholesterol. The reporter was calling because her mother had the COVID-19 Vaccine on 07Jan2021, it was on a Thursday. By that Friday (08Jan2021) she was not feeling that well. Caller stated she did not know if what occurred had any correlation to the vaccine, but she wanted to report these details in case this started to be came a problem. Her mother is 94 years old and was in very good shape. However, now she was in the hospital completely disoriented. Since getting the vaccine she had subsequently broke out with shingles two days after getting the vaccine on 09Jan2021. Caller reiterated she was not saying this had anything to do with the vaccine, but she just wanted to reported these events. Caller initially stated it was unknown why patient was admitted to the hospital. She went on to explain her mother, the patient, was complaining of pain and burning. She started complaining of this pain and burning in the evening like around 5PM (on 08Jan2021 17:00). She later broke out into shingles. Caller mentioned patient has not had the SHINGRIX vaccine yet. However, she did have the older vaccine, ZOSTAVAX. Caller confirmed patient received the ZOSTAVAX years before. Patient went to the Emergency Room the first time on 09Jan2021 due to complaining of pain and burning and they could not find anything wrong with her. They checked her vitals and ran several tests and it all came back fine. They then sent her home. Patient went back to the Emergency Room on 10Jan2021 and completed another battery of test, labs, checked vitals, had chest x-ray, and cat scan at this time they could not diagnose with Shingles. On 11Jan2021, the patient had an appointment with her Primary Doctor and he did not find anything wrong. Patient came home with caller's sister and she was helping her get undressed. That was when the sister noticed a rash on the patient's body. The rash broke out on her body on Monday 11Jan2021. They tried to call the doctor that night, but did not get a response. On Tuesday 12Jan2021 they took the patient to urgent care and that was when she was formally diagnosed with Shingles. She was started on medication for the Shingles, Acyclovir, and sent home. They also thought she had a slight Urinary Tract Infection. She was started on CIPRO for the urinary tract infection. Patient was home for a couple of days in Jan2021 and she was not getting any better. She was then starting to lose her mental faculties. They thought this was from the urinary tract infection. Caller clarified the patient was then admitted to the hospital on 16Jan2021 due being disoriented. For causality assessment, it was mentioned that it is so coincidental this happened right after getting the vaccine. She was healthy and then it was like a snowball. The outcome of the events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Exhibiting rash like inflammation on right arm. Covers 80% of her arm, 20cm by 8cm, skin is red and swollen. No treatments at this time. Waiting for Dr. to Sign response and plan.

Rash on same arm as shot received but not at injection site; rather outer arm closer to elbow. Mostly circular approximately 3-4" in diameter. Itchy a little when first noticed but not for long. The rash was gone after 4-5 days.

Vertigo last week that stayed for five days; pain at the injection site; 2 stroke like symptoms/ like she was having a TIA (Reporter confirmed TIA as Transient ischemic attack); Blood Pressure 170/130; Fatigue; Joint ache; Nausea; Vomiting; Fever 100.1; Stress; 2 stroke like symptoms/numbness in her lip; Pervasive aching; Momentary confusion; , like she was having a TIA; Not able to answer questions; she still has not recovered her strength; This is a spontaneous report from a contactable consumer (patient's daughter). A 94-year-old female patient (mother) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL1283), via an unspecified route of administration on 23Jan2021 13:00 at a single dose for COVID-19 immunisation. The patient's medical history included ischaemic stroke, haemorrhagic stroke in Aug2019, pulmonary embolism, deep vein thrombosis (DVT), cholesterol, myalgia condition, blood pressure, thyroid, sleep and vertigo. The patient concomitant medications included amlodipine for blood pressure, calcium carbonate/colecalciferol (CALCIUM + VITAMIN D), rosuvastatin calcium (CRESTOR) for cholesterol, levothyroxine for thyroid, eszopiclone (LUNESTA) for sleep medication, ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2), prednisone for myalgia condition, and escitalopram. The patient experienced fatigue, joint ache, nausea, vomiting, blood pressure 170/130, fever 100.1, stress, stroke like symptoms, numbness in her lip, momentary confusion; like she was having a TIA; not able to answer questions, tired, pervasive aching, all on 23Jan2021 19:00. Events reported as follow: patient had the Pfizer vaccine on Saturday around 1 pm and Saturday (Clarified 23Jan2021) night she had severe side effects for about 4 hours. When probed for side effects, the reporter stated it increased gradually over time. So, first patient had joint achiness and then she experienced nausea and vomiting. The reporter took her blood pressure. It was 170/130 and so reporter called EMS and they came up and her blood pressure had gone back down to normal and they recorded she had a fever of 100.1. EMS believed that the combination of the 'violence' of the onset and the fever caused her blood pressure to spike but she had a history of ischemic and hemorrhagic stroke. So, the reporter was concerned that the stress and whatever that was going on the reaction, the reporter was concerned that it was going to cause her a stroke. Patient had 2 stroke like symptoms, one was that she had numbness in her lip and the second was that she had momentary confusion, like she was having a TIA (reporter confirmed TIA as Transient ischemic attack). The only symptom of that was when the reporter asked her the name of her children she gave the names of her grandchildren but that confusion cleared up quickly and she was fine for a while but not able to answer questions, sharply. By the time that EMS got there patient was sharp again, no problem. For treatment, the reporter gave patient aspirin. The reporter put some Salonpas patches on her joints. It was like the analgesic patch. It was an external patch that patient put on. Patient usually does not need them that was why she was taking the prednisone to treat that kind of pervasive aching. The reporter also gave her the fluids, Gatorade kind of stuff to replace her fluids from throwing up and that kind of stuff. One more thing, it all started with an extreme fatigue but that seem normal but it seemed to lead into the other symptoms. Like it was a big day to go out and get the vaccine. So, she was a little bit tired. This was a very deep fatigue that was part of it too. Reporter stated only 81 aspirin (later clarified as treatment) as she could not go back on blood thinners because she had the hemorrhagic stroke. As of 11Feb2021, it was reported that patient still has not recovered her strength since 23Jan2021 19:00 and was reported as ongoing but improved. On 03Feb2021, the patient had vertigo that stayed for five days and was now improved. The patient was scheduled for the second dose on 13Feb2021. The immediate effects her mother had after the first dose of the vaccine were pain at the injection site; fatigue; fever; nausea. Mentions she also had some confusion and they were worried that the patient might be having another stroke. But all of this cleared up; all of this in a violent episode that lasted about four hours. Today she wants to report that her it took her a week for her mother to recover. Adds her mother could walk for half an hour before the vaccine but since the vaccine she still has not recovered her strength. Adds her mother has only been able to walk about 15 minutes with a walker and resting a lot, for a couple time in three weeks and this was their main way of maintaining her health. Adds her mother also had some vertigo last week that stayed for five days but she has had that in the past. Adds actually she still has the vertigo a little and she can tell when her mother bends her head. Outcome of blood pressure 170/130, she still has not recovered her strength and vertigo was recovering, outcome of events pain at the injection site, fatigue, fever, nausea and confusion was recovered on 23Jan2021 23:00; other events was unknown. No investigation assessment. Follow-up (11Feb2021): New information received from the same contactable consumer (patient's daughter) includes: reporter details, medical history, reaction data and course of events.

2 days following her Pfizer shot, patients face started burning all over and became bright red. Redness and pain continues but has lessened some to date (3/31/21). Face started to peel a couple of days ago and is continuing to peel. Patient describes it as a very intense sunburn, but she has not been out in the sun. Patient is now on day 12 of reaction.

Severe itching, rash type blotchy. Started a week or so after second injection. Continues to worsen. Doctor denies it is from vaccine.

her arm started feeling funny and she checked it and it was red; itchy; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 94-year-old female patient (94 years age at vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9267; Expiration Date: 31May2021), via an unspecified route of administration in right arm on 20Feb2021 (Saturday) at 09:30 as single dose for COVID-19 immunisation. The patient did not have any other prior vaccinations (within 4 weeks) except the COVID-19 vaccine first dose. The patient had been vaccinated with his first dose of COVID-19 vaccine (Batch/Lot Number: EL3248; Expiration Date: 30Apr2021), via an unspecified route of administration in right arm on 30Jan2021. The first shot was fine. She got a little reaction. Other medical history included ongoing blood pressure and cholesterol level (unspecified -high/low) abnormality. The patient's concomitant medications included unspecified cholesterol and a blood pressure medication since unspecified years. She had been on cholesterol medication unspecified years ago and it kept her study. She was on both blood pressure and cholesterol medications when she got the vaccine. She had been visiting the doctor once a year. Two days after vaccination (on 22Feb2021, Monday), the patient experienced her arm started feeling funny and she checked it and it was red. At the time of report, the redness was getting bigger all the time. It was itchy and red. The outcome of events was not recovered.

Unable to write as normal next day Mental decline and unable to care for herself Hospitalized 2 weeks later for dehydration Noticed reddened and painful R arm down to elbow Now back in hospital 5/18/21 with unresponsiveness, UTI and dehyration

1/8/21 Area of blue/purple discoloration measuring 5cmx4.5cm, to where injection of the Pfizer Covid-19 vaccine was given on 1/7/21. Resident moves arm when area touched. Scant amount of dried blood noted to area where resident appears to have been scratching. Resident afebrile without rash to area. Minor swelling noted at site.

the morning after her vaccine, her daughter noticed a rash on her left hip with red blisters. Noted Sat 1/9/2021. She was seen in my office on 1/13/2021 and I diagnosed her with shingles. Rash had spread over the 4 days to a dermatomal distribution from left mid back around to left mid abdomen. She had received the Zostavax vaccine in 2007.

A burning/itching rash and blisters started on 1/30/21. It completely covered her backside/buttocks. She was prescribed Acyclovir 800mg on 2/2/21. The rash has subsided however, because of the location of the blisters, they still haven't completely healed.

96 yo F presents with with thrombocytopenia, suspected ITP. Pt had the Pfizer COVID vaccine approx 4 weeks ago. She initially developed an itchy rash on her lower/mid back. Over the last 2 weeks, she also developed increased bruising/purpura on her flank/hip and LEs. Her son, a radiologist, came to town late last week and noted that in addition to bruising, she had what appeared to be petechiae on her LEs. Son had her skip her 2nd dose of vaccine (scheduled for Friday) and took pt to PCP for blood work. CBC apparently showed PLT of 9k so pt went to ER. Repeat PLT was 11k and pt was admitted overnight. She received dex 40 mg IV x 1 on 2/20/21. Repeat PLT today is 11k. Family reports she had normal blood work including CBC about 1 year ago. No active bleeding. No change in mental status No recent viral or bacterial infection. She otherwise feels well. No history of blood disorders or ITP. No history of autoimmune disease.

a bruise on her ankle and it split open; a bruise on her ankle it split open; soreness of her arm where she got the injection after the first dose; back spasms pain; back spasms pain; This is a spontaneous report from a contactable consumer (the patient) via the Pfizer-sponsored program. A 95-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date (at the age of 95-year-old) as single dose for COVID-19 immunization. Medical history included using a wheelchair. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced soreness of her arm where she got the injection after the first dose at 12 noon and then at 10 pm she had the pain. On an unspecified date, she had a bruise on her ankle and it split open so she put POLYSPORIN (bacitracin and polymyxin B) on it. Then she bruised it again on her wheelchair. She also reported experiencing bad back spasms pain for 3-4 days which happens periodically (unspecified date). The clinical outcomes of the soreness of her arm where she got the injection, back spasms pain and a bruise on her ankle it split open were unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

Skin in the elbow and knee crease presented like a burn. Very warm to the touch and very painful when touched or when moving. Went to the DR and he prescribed silverdene creme and antibiotics. Went to the emergency room for pain medication Went to the dermatologist after 10 days. Prescribed lidocane creme. After 2 weeks started to spread on the face . Presented the same as other skin but not as bad. Also spread to the wrists but presented more like and ecxema.

Patient presented after falling on February 5 with injury to her scalp. She apparently also fell on 2/4/21. Family was uncertain as to whether patient loss consciousness. According to family, patient has been weak over the last day or 2 with no other complaints aside from some diarrhea. EMS was notified PM Feb 5, and the patient was found to have atrial fibrillation with elevated heart rate to the 160s and hypoxic to the low 80% range on room air. She had a low-grade temperature and elevated respiratory rate according to EMS. Evaluation in the ED demonstrated bilateral chest infiltrates on chest x-ray (right greater than left), elevated heart rate with atrial fibrillation, and back pain. Imaging demonstrated a T11 compression fracture (possibly new), elevated pro-calcitonin (2.80 ng/mL) and elevated troponin (1.45 ng/mL). Her venous blood gas showed mild hypoxemia (7.39/25/41/33/57), and head CT did not show acute changes and her cervical CT was negative for fracture. Pelvic x-ray did not show fracture. She was covid positive. Admitted for acute hypoxemic respiratory failure and severe sepsis secondary to COVID-19 pneumonia and acute metabolic encephalopathy. Received 3 days of remdesivir and 4 days of IV dexamethasone. Also ceftriaxone was given 4 days for possible UTI. Goal of care switched to inpatient hospice on 2/8/21.

can barely walk; upper respiratory problems; Sinus infection; has not been well/ bad shape/ can't be out of bed for 2 seconds with out having to get back into bed/ wasn't feeling good/ not feeling well; chills; fever as high as 104.5; nasal congestion; upper respiratory difficulty breathing/ can't breathe through her nose; non-productive cough; breathing rapid; Arm pain/ sore arm around the injection site; This is a spontaneous report from a contactable consumer (Caregiver/ Patient's daughter). A 95-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 14:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Mar2021. The patient was reported to have possible side effects that was getting worse. The patient had "chills, fever, nasal congestion, upper respiratory difficulty breathing, non-productive cough." On Monday evening, 29Mar2021, the patient was brought to the hospital but tests showed that "everything looked good" (chest x-ray etc.) Last night, the patient's temperature reached 104 F and was given paracetamol (TYLENOL). The patient mentioned that she was "breathing rapid," and that she "coughs when she takes a breath." Reporter asked if patient can be given an antihistamine; or something to help with the upper respiratory concern (nose blockage, upper respiratory breathing). The patient had not been well. They spent Monday evening and all night and in the morning at the hospital. They did X-rays and lab work and everything else. The doctors couldn't find anything wrong with her and stated that it's got to be the vaccine. She was really in bad shape at this point. She can't be out of bed for 2 seconds without having to get back into bed. She was having a upper respiratory thing going on. She had a fever as high as 104.5 last night. The fever was last night and she got paracetamol (TYLENOL) for that and brought it down. It did respond. The patient stated she can't breathe through her nose and she has upper respiratory problems. The problem was when they went to the hospital, they didn't find signs of infections, all normal across the board. The patient doesn't fake it, she was a feisty elderly lady. She walks up the hill every day. She was independent. Normally, she can walk and walks very well without any assistance. The patient now can barely walk. She can barely walk to the toilet without holding on to anything. She was constantly complaining about chills. Reporter wanted to know what can they do and not do and what should the doctors be looking at. They kind of just threw up their hands as this was side effects of the vaccine, but the patient was alarming on Monday night and even more alarming right now. The patient was in bad shape. She wasn't feeling good on Saturday night, but not too bad on Friday night. Reporter asked her mom how she felt on Friday. Reporter told her mom to put in her hearing aids, that would probably help. Reporter further explained that patient had a sore arm around the injection site and that she might not have been feeling that great. On Saturday, she was not feeling well and started to have a fever, sinus infection and upper respiratory problems. The patient stated that she finally identified it. Reporter confirmed the fever, sinus infection, and upper respiratory problems started on 27Mar2021 towards the late afternoon she was progressively getting worse. Fever, sinus infection, chills, upper respiratory problems all have worsened. The reporter stated that her mother's (patient's) arm pain got better on Sunday and was now gone. On Saturday, her arm hurt from her shoulder to her elbow, it did get worse. However, a the next day it was gone pretty much. Monday in the emergency room, they did labs for her kidney, liver and were looking for infection. They did not find anything came up normal on everything. Today, the reporter thinks patient was worse. She doesn't want to come out of bed at all. She was laying there like a lump, whining and crying which she has never done. She was probably going to take her to the hospital again and they were not going to do anything again. She stated that something got to change, They haven't had that conversation about going to the hospital. She was going to go downhill if this continues, it had gone downhill at this point. Reporter confirmed that patient has recovered completely from the arm pain while outcome of remaining events was not recovered. Information about the lot/batch number has been requested.

Hives on back, arm and shoulder blade that are itchy and burning sometimes; Hives on back, arm and shoulder blade that are itchy and burning sometimes; Hives on back, arm and shoulder blade that are itchy and burning sometimes; This is a spontaneous report from a contactable consumer. A 95-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for Injection; Lot number: Unknown) via an unknown route of administration in the left arm on 29Jan2021 at 11:00 as single dose for COVID-19 immunization. The patient medical history included allergies to Penicillin, Bactrim and cholesterol medicines. The patient previously received the first dose of bnt162b2, via an unknown route of administration in the left arm on 07Jan2021 at 12:00 as single dose for COVID-19 immunization and experienced rash and hives on stomach, hip arm and shoulder blades on 11Jan2021 at 09:00 (the events resulted in doctor or other healthcare professional office/clinic visit and outcome was not recovered). The patient was healthy. The patients concomitant medications was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On 29Jan2021, at 11:45, the patient developed hives on back, arm and shoulder blade that are itchy and burning sometimes. It was two weeks since second vaccine and it was still bothering the patient. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The reporter assessed the events to be non-serious. The outcome for the events was not recovered. Information on lot/batch number has been requested.

rash; shingles; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 95-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left, at the age of 95 years, on 03Mar2021 (Batch/Lot Number: EN6199) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included memory loss and dementia; both from an unknown date and unknown if ongoing. There were no concomitant medications. The patient's daughter took the patient to get the first dose of the covid vaccine. The patient was in a nursing home. The nurse from the nursing home called the reporter and told her that the patient had shingles last Sunday 21Mar2021. The patient was due for her second dose of the covid vaccine tomorrow, 24Mar2021. The reporter was asking what the protocol for this was and what she should do about patients second dose of the vaccine. Currently, according to the nurse at the nursing home, the patient is taking medication for shingles. She was using a topical medication and taking a medication by mouth. The reporter stated that the nurse at the nursing home did not go into details about what kind of medications patient was using. Since the nursing home is a facility reporter did not ask. The reporter stated that honestly she spoke with patient yesterday and did not ask patient about the rash. The patient did not say anything about her rash. The reporter stated that patient was fine, and was in good spirits. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown.

Event- Hives all over body Treatment- Medrol Dose Pack, Benadryl, Singular and labs Outcomes- itching has subsided, hives still present at this time

Excerpt taken from patient's medical record notes. Recreational Therapist was in room with patient who was at baseline mentation at that time, and was getting patient a cup of tea. Rec Therapist observed patient to "all of a sudden slouch down toward left side" and became unresponsive. Therapist called for help, and Registered Nurse (RN) and Certified Nurse Aide (CNA) came into room. Patient was initially non-responsive and profusely sweating and hot to touch. Vitals were taken (see below). The patient then slowly became responsive after approximately 4 minutes and was visibly nauseous and appeared like she was going to vomit, but ultimately did not. Patient was assisted into bed, APRN was called, order for vital signs to be taken every 4 hours for 72 hours, and Electrocardiogram (EKG) to be performed. EKG results were abnormal, indicative of infarct; APRN ordered transport to Emergency Department. Patient returned from Hospital ED at approximately 10:45 PM same day (1/28/21), with transfer paperwork documenting a Hospital diagnosis of "Syncope" without any additional lab results or any new medication or treatment orders in the documentation. Follow up the next day (1/29/21) by RN at the Nursing Facility--RN logged into the Hospital medical Charting system, only to find that there was no record whatsoever of the patient being in the Emergency Department on 1/28/21--no notes, no labs, no summary from a practitioner. Patient recovered and has resumed close-to-baseline activity and functioning.

Extreme redness and warmth over the injection site and larger area---involving almost entire upper arm. Complains of itching; not painful. Worse on day 3 (yesterday). Appears to be responding to steroid cream.

Very red arm at the injection site noticed it last Friday 3/19/2021, arm not sore, not elevated, not warm to touch. Aquaphor was applied to the area

her legs were red, the back of neck, stomach and arms; a little swelling under eyes and middle of back; rash all over the body; This is a spontaneous report from a contactable consumer.A 96-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: EL9264), via an unspecified route of administration on 02Feb2021, 6PM as single dose at left arm for covid-19 immunisation. The patient medical history included scoliosis, skin problems off and on prior to the vaccine and have dermatitis and other skin issues which had been diagnosed for years. the patient concomitant medication was not reported. on her legs were red, the back of neck, stomach and arms and a little swelling under eyes and middle of back and chest had some rash, states it is a dry rash. States that on Monday prior to the vaccine, one of her cheeks was red, that by yesterday she had a rash all over. the patient was is shrinking from scoliosis. On 03Feb2021, the patient had a rash come over her body . the outcome of event rash was not recovered. outcome of events her legs were red, the back of neck, stomach and arms and a little swelling under eyes and middle of back was unknown. No follow up attempts are possible. No further information is expected.

up all night; Itching; has small bumps; some areas of redness; This is a spontaneous report from a contactable consumer. A 96-year-old female patient (Reporter's mother) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 08Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (they hope the mother doesn't contract COVID). Medical history included stomach issues, blood pressure, cholesterol. Concomitant medication(s) included loperamide hydrochloride (LOMOTIL) taken for stomach issues. The patient experienced itching with, has small bumps, some areas of redness; all (non-serious) on 09Feb2021 and up all night (non-serious) on 10Feb2021. Therapeutic measures were taken as a result of itching (pruritus). Additional Information for Concomitant Products Lomotil, cholesterol and one for blood pressure: Reporter declined to provide any further information for medications such as when her mother began taking these medications, the dosages, or further information related to the medications. Reporter was calling for her mother. Her mother had her initial shot on the 8th, 08Feb2021, and she got up the next morning and was complaining of itching and had some areas of redness and bumps that went around the nape of her neck. She has small bumps around her neck, under her chin, on her chest area going down mid-line- from her chin- and then down under her breast. It itches and she didn't have that before. Clarified with caller that the shot being discussed is the Pfizer COVID vaccine. Reporter said areas of itching and bumps are still there today, she wanted to wait a little bit to see how it was going to be, but her mother still has it. Her mother does have a sensitivity to medications. You know, a lot of oral medications she can't really tolerate, it bothers her stomach. She's not really allergic to anything in particular- caller asked her mother, "are you mom, no." She just wanted to clarify that information. Her mother does have a sensitive stomach, but the COVID vaccine shouldn't have anything to do with the stomach. No further details provided on the oral medications that the mother is unable to tolerate that bother her stomach. Two days ago, the caller's mother had the COVID vaccine on the 08Feb2021 and she woke up that evening. While she was going to bed she noticed she was itching. When she got up in the morning she said she was up itching all night. The reporter says, so we will say 09Feb2021 is when this all started. Reporter makes a comment that her mother is a little thing. The reporter says her mother is about 4'5" 4'6" and her mother says she is 4'9" and the reporter says well she wants to say she is 4'9". On 08Feb2021 the patient had the COVID vaccine and then she had the itching behind her ears, on her neck, across her chest, and under her breasts. Clarified the date the itching began an 09Feb2021. The patient put something on that eliminated some of the bumps and every now and then the itching and scratching will feel like she's bleeding, but she is not bleeding anywhere. The bumps are still there. They are still red, the bumps are not red, they are an irritation. Conflicting information obtained in regard to bumps, unable to clarify or obtain further details due to the reporter not wanting to complete the safety report. Some areas of redness: Reporter says it is not really red, it is more off an off-color, pinkish. Reporter states that she can tell there's an irritation on the patient's skin from itching. Up all night: The patient was up last night 10Feb2021 when she went to bed. Reporter mentioned that her mother doesn't always relay information correctly. Company agent is unable to clarify if the inability to relay information correctly began prior to receiving the COVID vaccine or after due to the reporter not wanting to complete the safety report. The patient was up all night itching the last two nights. She feels the itching and gets some relief from an ointment she is using. Reporter is not sure of the name of the ointment off hand, but the patient was provided the ointment it is from the doctor. Unable to probe for NDC, lot number, or expiry date of ointment that only provided some relief to her mother as reporter did not wish to complete the safety report. Probed for NDC, expiry date, and dosage and reporter says this information is not on the vaccination card. Caller says the lot number is an "E" and she can't make up the next letter before 9262, it's either EL or E1 and it is separated from 9262, there is a space between them. Lot number is either: EL9262 or E19262 based on information provided from the reporter. Reporter says the mother takes medications everyday. She takes ones for her blood pressure, cholesterol, and Lomotil medication for her stomach issues. Reporter asks how much longer this is going to take and what further questions will be asked. She doesn't think the rest of the report is necessary she just wanted to report that her mother had the rash and the itching. Unable to clarify information regarding said rash with the reporter as being related to the redness and bumps mentioned previously in the report or if this rash is a different event that was experienced. Medical Conditions: Unable to obtain further information due to reporter not wanting to complete the rest of the safety report. Investigations: When informing the reporter that one question that will be asked for this report is if any testing has been done to what her mother experienced, the reporter says no. Unable to clarify if this means no testing has been completed or no to the reporter not wanting to answer the question at this time since she did not want to complete the safety report. Informed caller that an additional form is part of the safety report, caller declined to complete the safety report so unable to obtain further information and confirm given information to fill out the vaccine supplemental form. Reporter calling on behalf of the side effects experienced from her mother after the COVID vaccine. For all events, outcome was not recovered, except for event up all night, outcome was unknown. Information about Batch/Lot number has been requested.

shingles; itching; This is a spontaneous report from a contactable consumer (reported for her aunt). A 96-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 23Feb2021 (at the age of 96years) as 1ST DOSE, SINGLE for Covid-19 immunization. Medical history included high blood pressure. Concomitant medications included pill for high blood pressure. It was reported that the patient was healthy as a horse and her mind is sharp as a tack; she is slow getting around and does not get around well. It was reported that the patient has received the first dose of Pfizer COVID-19 vaccine on 23Feb2021. Nine days later (04Mar2021), she has developed itching in her back and at the upper part of her arms. The reporter wanted to know if it would be from the Pfizer COVID-19 vaccine and if the patient should receive the second dose of the vaccine considering her adverse event. It was clarified that the patient did not develop rashes but only itching. The patient has been to a walk-in clinic but was only given Benadryl and Claritin for her condition. It was further reported that the patient was fine, and her arm was not even sore today. The patient developed some itching on her back and arms after 9 days. The reporter asked, since it is that far out would if that have to do with an allergic reaction and related to the vaccine; also asked if it was contraindicated for the patient to get her second dose. For the symptoms the patient went to a walk-in clinic and the doctor did not think it was related to the vaccine. The doctor stated that the patient does not have a rash, but they seemed to think it could be a mild case of shingles, but they don't know. The outcome of event itching was recovering; outcome of event shingles was unknown. Information on the lot/batch number has been requested.

On 1/29/21 patient began not feeling well and saw her provider. The doctor gave her fluids and tramadol for pain. They noticed increased confusion, but thought that could have been due to the tramadol. They also increased her gabapentin as she was experiencing nerve pain. Patient also developed a rash and was diagnosed with shingles on 2/1/21. Patient died on 2/3/21

The following morning, grandma woke up with right wrist pain, mild swelling, and skin temperature is hot to touch. Sign and symptoms got worst for the next three days and up till today sign and symptoms are still evident.

Patient did not feel well and reports general malaise day 2 and day 3 post vaccination. She noticed itching of Right Breast on Day 3 and later that evening, noticed a rash with blisters.

Pt developed red, swelled, warm, painful RLE at lower leg/ankle/foot less than 24 hours, near 12-18 hours after 2nd dose.

Complaint of pain and redness and swelling in Right deltoid on 1/15/2021. Informed doctor. doctor phoned and ordered cold compressed x15 minutes QID prn. Tylenol 650 mg prn for pain. 1/16/2021 swelling is severe more redness. Rue moveable. monitored. 1/18/2021 swelling and redness wrosening and RN practitioner assesed and diagnosed with cellulitis and order antibiotic, clarithromycin 250mg bid x 7 days. Tylenol 1000mg TID daily x 5 days. Ice pack changed to TID x 15 minutes x 5 days. 1/20/2021 Swelling and redness still there but is resolving. Pt has refused pneumonia and flu vaccine in the past.

Resident presenting today with facial swelling that extends from Chin into neck area. Redness to face.

The day after receiving the first dose of the Pfizer COVID-19 vaccine, the patient developed shingles on one side of the face. No history of recurring shingles in patient.