VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1151393
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Patient tested positive on their covid test, tested positive the same day as receiving the vaccine.; This is Spontaneous report from a contactable Pharmacist . This Pharmacist reported similar events for two patients. This is a 1st of 2 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient tested positive on their covid test, tested positive the same day as receiving the vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021283276 Same reporter/events/ drug/diff patient

Other Meds:

Current Illness:

ID: 1151395
Sex: U
Age:
State: TX

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: fatigue; Joint pain/The joint and muscle pain I experience were primarily in my neck, shoulder elbows, wrist and fingers.; sore musles/The joint and muscle pain I experience were primarily in my neck, shoulder elbows, wrist and fingers.; headache; This is a spontaneous report from a contactable consumer. A 75-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Left on 14Jan2021 16:45 (Batch/Lot Number: EL3249) as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, and had 2 surgeries 1) was a discectomy in the lower back and 2) in 2019, right rotator cuff surgery. Prior to the surgeries, the patient suffered from arthritis that subsided following the surgeries and no longer take medications for the second surgery in 2017 was a cervical fusion of C2-3. Family's medical history includes: Mother- heart disease, Father- Cancer, Sister- COPD- cancer, and Brother- Diabetes type 2. Concomitant medications included amlodipine besylate; and metoprolol tartrate; taken for hypertension from unspecified start dates and ongoing. On 14Jan2021 21:00, the patient experienced sore muscles/joint pain, and headache (extreme). The joint and muscle pain the patient experienced were primarily in the patient's neck, shoulders, elbow, wrist and fingers. On 15Jan2021, the patient experienced fatigue. The events were assessed as serious (disability). The patient did not receive treatment for the events. The outcome of the events was recovered on 16Jan2021. It was reported that the patient received second dose of bnt162b2 on 04Feb2021 12:45 (lot number: EL9265) in right arm via intramuscular.

Other Meds: AMLODIPINE BESYLATE; METOPROLOL TARTRATE

Current Illness:

ID: 1151396
Sex: F
Age:
State:

Vax Date: 02/25/2021
Onset Date:
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: I got Covid; I got Covid; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported similar events for two patient. This is the first of two reports. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on 25Feb2021 as a single dose for covid-19 immunization. The patient's medical history included an auto immune deficiency, do not have a spleen, and anaemic all from an unknown date. The patient's concomitant medications were not reported. The patient was supposed to get the second dose to be somewhere between the 18Mar2021 and 21Mar2021. But she got Covid. The patient got the first dose and was supposed to go back and get it another week to take the second dose. But somehow at work like she was not in the office. Other ladies had it before she got it. But she have an auto immune deficiency, do not have a spleen and was anaemic. So her doctor said get the vaccine 'unless' she get COVID. Patient would like to know if she can still get her second dose after this. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021280057 same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 1151397
Sex: F
Age:
State: FL

Vax Date: 03/02/2021
Onset Date: 03/08/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: has a rash, it is itchy; kind of like the shingles/thinks it may have caused her to have shingles; has a rash, has bumps or pustules; has a rash, has bumps or pustules; it made her sick; This is a spontaneous report from a contactable nurse (patient herself). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 02Mar2021 10:30 (at age of 73-year-old) (Lot Number: EL9262) at single dose for COVID-19 immunisation. Medical history (including any illness at time of vaccination) and family medical History was reported as none. There were no concomitant medications or prior vaccinations (within 4 weeks). The patient stated she got the shot on 02Mar2021 and had a rash at time of the report. Added she was going to get scheduled for the next dose but is asking if she should get it with this rash. Clarified she received the first dose of the Pfizer COVID 19 vaccine 02Mar2021 at 10: 30AM in the left arm. She didn't get the rash right away. All of the sudden a week after the shot she woke up in the night Monday (08Mar2021) with a rash; kind of like the shingles; it was itchy and had bumps or pustules. The rash was located on her upper body; shoulders and arms. Added she could scratch her boot to hell. Stated she was an old nurse and she did a lot of things to try to stop the itching. Added it was so itchy. She treated her rash with Vicks vapor rub; Bag Balm; Greycaine powder to dry it up; and finally put diphenhydramine hydrochloride (BENADRYL) on it. She took aspirin; vitamin C; B12 and zinc. Added but this shot didn't work, it made her sick. Added she thought it may have caused her to have shingles and she had never had shingles before. She had not had the shingles vaccination. Added she was supposed to get the next dose of the Pfizer COVID 19 vaccine in three weeks. The events did not result in emergency room visit or physician office visit. Therapeutic measures were taken as a result of 'has a rash, it is itchy, has bumps or pustules'. The outcome of events was not resolved.

Other Meds:

Current Illness:

ID: 1151398
Sex: F
Age:
State: PA

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: head and ears were itchy; but she has gastrointestinal issues; A little bit of erythema; diarrhea; On her neck she had hives up to her face and down her chest a little bit/urticaria eye lid; rash on neck up to her face; rash on shoulder that she had injection in; This is a spontaneous report from a contactable other hcp (nurse). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6206), via intramuscular route of administration, in the right arm on 05Mar2021 09:30 (at the age of 64-years-old) as single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, anaemia, cardiac disorder, rash (She has had a reaction to IVP dye. She has to pre-medicate with benadryl and a steroid 10 hours before, then 8 hours before, then 1 hour before procedure prior to receiving IVP dye. When querying NDC/Lot/Expiry for IVP dye, caller states she does not have that information, it happened years ago. She always pre-medicates when she has to have have x-rays with the dye). The patient did not have history of all previous immunization with the BNT162B2 vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). Concomitant medications included tofacitinib citrate (XELJANZ XR) via oral route of administration from an unspecified date (been on for 2 years) and ongoing at a dose of 11 mg daily for rheumatoid arthritis; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) for an unspecified indication; tramadol (TRAMADOL) via unspecified route of administration from an unspecified date and ongoing at a dose of 50 mg daily (in morning) for rheumatoid arthritis; gabapentin (NEURONTIN) via unspecified route of administration from an unspecified date and ongoing at a dose of 300 mg twice daily for rheumatoid arthritis and Multivitamin for an unspecified indication. The patient previously took buprenex and experienced drug hypersensitivity, buprenex and experienced nausea and vomiting, avelox and experienced angioedema. The patient did not underwent any Lab tests.The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than BNT162B2 Vaccine prior to the event being reported.The patient did not received any other vaccines around the time of BNT162B2 vaccination. She was calling about the Covid vaccine. She had her first dose this past Friday, clarified 05Mar2021. It's been a week. On the evening about 8 hours after the Covid 19 injection she got a rash on her shoulder that she had the shot in. The rash went across her chest to the other shoulder. On her neck she had hives up to her face and down her chest a little bit. She has been taking Benadryl for the past 6 days. She is very concerned what is going to happen with the next dose. She contacted her primary health care provider and it was recommended that the caller pre-medicate. The caller states it says not to pre-medicate. She has her next Covid 19 vaccine in 2 weeks and she was nervous. She did file a report with the government. It was in the information she received from the hospital where she got her Covid 19 injection. Every day at 2:00PM she gets a text message. They monitor her for up to a year. Every day she checks in and says how she feels, is she having trouble completing daily activities, did you have to call your doctor. They gave her a paper at the hospital where she had it done. When querying if this government program had given her a report number she states she doesn't have a report number, she deletes the text messages every day. She is due for the second Covid vaccine on 26Mar2021. It was reported that several hours after the injection in the evening, maybe 8 hours after she had the injection is when her symptoms began. She does feel like she is improving. Today was the first morning that she didn't take the Benadryl. She had no respiratory problems. But she was very concerned because the hives were pretty prevalent. It was very uncomfortable. She was taking 50mg of Benadryl for 5 days. When she went to the pharmacy to pick up a cream too, the pharmacist thought that a steroid would be good. She was concerned. She emailed her primary care doctor with pictures. When querying seriousness of events, caller states it was bad enough that she went to the pharmacy and called her primary care doctor and sent her pictures. If she had developed any respiratory issues she would have gone to the emergency room. If she was non medical she would have gone to the emergency room but because she's a nurse she thought she would ride it out. When querying information for the Pfizer Covid 19 Vaccine data capture aid, the caller reports the hives were 48 hours later. She also reports urticaria, her head and ears were itchy. She is using steroid cream on it. It is driving her crazy today. Still going to be using the cream. A little bit of erythema, worst part was her neck. When querying red and itchy eyes, she reports only the eyelid. When querying gastrointestinal issues, she reports she has diarrhea, but she has gastrointestinal issues. The diarrhea is nothing worse than what she normally has. She doesn't think this has anything to do with the vaccine. The patient did not visited to emergency room and physician office. The patient was not hospitalized or admitted to an intensive care unit. Therapeutic measure were taken with Benadryl 25-50mg (Lot Number:P134952, Expiration date: Sep2021) and Hydrocortisone cream 1% maximum strength for the events. It was reported that Benadryl makes her hyper and her heart racey.The outcome of the event diarrhea, gastrointestinal issues were repoorted as unknown, event head and ears were itchy was not recovered and recovering for other events. The events rash on shoulder that she had injection in, hives on neck, rash on neck up to her face were assessed as serious (medically Significant) by the reporter. The causality of the events rash on shoulder that she had injection, hives on neck, rash on neck up to her face were reported as related to vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: XELJANZ XR; VITAMIN D [ERGOCALCIFEROL]; TRAMADOL; NEURONTIN

Current Illness: Rheumatoid arthritis

ID: 1151399
Sex: M
Age:
State: NY

Vax Date: 03/03/2021
Onset Date: 03/01/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: his blood pressure reading that was taken in the ambulance on his way to the hospital Emergency Room was 190/114; Sweating; he woke up in the morning, and the room was spinning / Vertigo symptoms; dizzy/extreme dizziness; he felt lightheaded, and was afraid he might fall; things were a little fuzzy in his head, and he couldn't remember exactly when he had gone to the Emergency Room; things were a little fuzzy in his head, and he couldn't remember exactly when he had gone to the Emergency Room; he was only nauseous when he was dizzy; Reported he eyes were not that good while he was reading the paperwork from the Emergency Room; he thought he had a heart attack; This is a spontaneous report from a contactable consumer (patient) A 67-year-old male patient received the first dose of the bnt162b2( PFIZER-BIONTECH COVID-19 VACCINE, Lot Number:EN6198, Expiration Date: Unknown), via an unspecified route of administration, left arm at single dose for Covid-19 immunization On 03-MAR-2021 (between 11:30-12:00). Additional vaccines administered on Same Date of the Pfizer Suspect was none. The patient medical history included depression reported he was diagnosed with depression years ago and has been on Wellbutrin for a while. No further details provided, Tinnitus he self-diagnosed himself a hissing sound mostly in his right ear for less than a year. He said he looked up his symptom on the internet and found someone else who had the same symptom as him, and that person said it was Tinnitus, Seizure he had a seizure about a year ago. Reported he had a seizure about a year ago. He said he had a brain scan afterward, and the doctor didn't find anything wrong. No further details provided. Concomitant medications were not reported. On 03Mar2021 Patient received his first Pfizer COVID-19 Vaccine (on) and was fine. He said about a week after getting his first COVID-19 Vaccine, he woke up in the morning, and was sweating, and the room was spinning, and he was dizzy. Little fuzzy in his head, and he couldn't remember exactly when he had gone to the Emergency Room: He said the room spinning and him being dizzy had been continuing to go on. He said he thought he had a heart attack, and went to the hospital (Emergency Room). He said his blood pressure was high. He said he was nauseous too. He said his dizziness hadn't stopped. He said the dizziness gets so bad, he can't get around, if he lowered his head below his shoulders, the dizziness gets really bad. the dizziness won't go away. the Emergency Room doctor thought his dizziness may be due to his inner ear. The Emergency Room doctor told him he should see an ear doctor about his dizziness. He said the his dizziness happened directly after he got his first COVID-19 Vaccine. Reported he went on the internet, and read that other people who got the COVID-19 Vaccine were experiencing same thing he was. No further details provided. It was Reported patient blood pressure was very high. He clarified his blood pressure reading that was taken in the ambulance on his way to the hospital Emergency Room was 190/114. He said he believed his blood pressure was taken again, and his blood pressure was a little bit better. He said his dizziness hadn't stopped. He said the dizziness gets so bad, he can't get around. He said if he lowered his head below his shoulders, the dizziness gets really bad. He said the dizziness won't go away. He said he was nauseous too, but only when he was dizzy. He said his dizziness was fine last night, but then he got up this morning and the room started spinning out of control. He said he felt lightheaded, and was afraid he might fall. He said if he tried to pick up something off the ground, his dizziness really comes on. He said the Emergency Room doctor thought his dizziness may be due to his inner ear. He said the Emergency Room doctor told him he should see an ear doctor about his dizziness. He had an EKG done in the Emergency Room, and since the doctor didn't say anything about his EKG, he assumed there was nothing wrong with the EKG results. He stated that he went to hospital as he was fearful he was having a heart attack; it was determined that he was not. However, he was advised him to consult a specialist as he may be suffering from vertigo. Treatment was given a low dose of oral Lorazepam 0.3mg to calm him down. He stated he did not have the Lorazepam 0.3mg NDC. He said his paperwork from the Emergency Room listed his diagnosis as Vertigo symptoms, and it was recommended he go for a hearing test because his dizziness maybe caused by his inner ear. The outcome of event was unknown.

Other Meds:

Current Illness:

ID: 1151400
Sex: F
Age:
State: TX

Vax Date: 02/20/2021
Onset Date: 02/24/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono); I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; This is a spontaneous report from a contactable Other HCP reported for herself and fetus. This is mother case. A 40-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El9266), via an unspecified route of administration on Left arm on 20Feb2021 08:00 at single dose for covid-19 immunisation administered at Hospital. Medical history includes Shellfish Allergy. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El3248), via an unspecified route of administration on Left arm on 27Jan2021 09:30 at single dose for covid-19 immunisation. Concomitant medications in two weeks include ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported, she was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono) on 24Feb2021 08:00 on visit of Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received Dilation and curettage (D&C) treatment for the events. Last menstrual date was 04Jan2021. Delivery date is Oct2021. Gestational period was 7 weeks. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient had COVID tested/nasal swab post vaccination with results pending on12Mar2021. The outcome of event Miscarriage was resolving and for the other events it was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Induced abortion cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021278790 Same reporter/drug, different patient /event (Fetus case)

Other Meds: PRENATAL VITAMINS [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PYR

Current Illness:

ID: 1151401
Sex: F
Age:
State: PA

Vax Date: 03/07/2021
Onset Date: 03/01/2021
Rec V Date: 03/31/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Intense pain in my right side of head, face and neck; Vomited; Hasn't been able to sleep because I have been in pain for the past 48 hours; "I have been diagnosed with TMJ; This is a spontaneous report received from a contactable consumer (reporting for herself). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EN6199, expiration date: not reported), via an unspecified route of administration in Arm Right on 07Mar2021 as single dose for COVID-19 immunization; ibuprofen (formulation: unknown) via an unspecified route of administration, start and stop date, and dose were not reported for an unspecified indication. Medical history included migraine. There were no concomitant medications. Patient stated, "I have just been having a, I think a pretty bad reaction to the Pfizer Vaccine. I went to the ER yesterday, I have pretty consistent just intense pain in my right side of my head, face and neck. I mean I am not sure if you could tell me how long this is going to last. I have been in pain consistently about 48 hours. Treatment received I have been taking Ibuprofen, Acetaminophen, Magnesium and I went to the emergency room and they administered 2 stronger NSAIDs, I only remember one of them was like Pyridol and I don't remember the other one. stated, It started on the day after the shot was administered, March 8th and it has been on and off until today except for the past 48 hours. It has been steadily present and hasn't gone away, it is persistent. in Mar2021 I just vomited and I haven't been able to sleep because I have been in the pain for the past 48 hours. Lab work: Consumer stated, did some lab work, they did a blood test when I was in the hospital yesterday and was diagnosed with TMJ in Mar2021. I am calling because I had a reaction to the Pfizer vaccine, I got the vaccine on Sunday and since Monday night I have had very intense pain in my head, face jaw and neck. For the first 2 days it was on and off and then for the last almost 48 hours it's been constant. I had to go to the emergency room for pain management but I came back home immediately. I wanted to ask about how long these side effects may continue, what can be done and whether or not I should get the second dose scheduled". The outcome of the event Pain was not recovered and for rest events outcome was unknown.

Other Meds: Ibuprofen

Current Illness:

ID: 1151402
Sex: M
Age:
State: CO

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: The headache in the right eye was most troublesome; Nausea; Diarrhea; Achy; severe exhaustion; This is a spontaneous report received from a contactable consumer. This consumer reported for a 56-year-old male patient received first dose of BNT162B2 (Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Left Arm on 03Mar2021 11:00 am as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Allergies to medications, food, or other products: no. Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Not sure. The patient experienced the headache in the right eye was most troublesome (non-serious), nausea (non-serious), diarrhea (non-serious), achy (non-serious), severe exhaustion (non-serious); all on 03Mar2021 12:00 pm. Treatment was not received for the adverse event.Headache on right side, nausea, diarrhea, achy, severe exhaustion. The headache in the right eye was most troublesome. The outcome of all events was recovering.

Other Meds:

Current Illness:

ID: 1151403
Sex: F
Age:
State: CO

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: After receiving the first shot, developed a headache on right side; later that evening had a runny nose; Nausea; Diarrhea; Loss of appetite; Sleep loss; Achy; Overall exhaustion; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6203, on 03Mar2021 11:00 at single dose in left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. After receiving the first shot, the patient developed a headache on right side on 03Mar2021 11:00, later that evening had a runny nose, nausea, diarrhea, loss of appetite, sleep loss, achy and overall exhaustion. This lasted for 7 days. Treatment received for headache and achy included Tylenol on day 3. The outcome of all events was resolving.

Other Meds:

Current Illness:

ID: 1151404
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: My tongue started tingling on the opposite side from where I got my shot. It would tingle for around an hour and then would stop for about two hours.; This is a spontaneous report from a non-contactable consumer (patient). A 51-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that her tongue started tingling on the opposite side from where she got her shot. It would tingle for around an hour and then would stop for about two hours. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1151405
Sex: M
Age:
State: FL

Vax Date: 02/16/2021
Onset Date:
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: he is not feeling well earlier; This is a spontaneous report received from a Sponsored Program. A non-contactable male consumer (Patient) reported for himself that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that his second dose appointment was scheduled today 09Mar2021 and he got his first dose appointment last 16Feb2021. He stated that he was not feeling well earlier that was why he decided not to take the second dose and he was trying to reschedule it on the system/online right now and during probing question he mentioned that he was feeling better now. He was looking forward in rescheduling the second dose on 11Mar2021. The outcome of the event was resolving. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1151406
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: tested positive on their covid test, tested positive three days after receiving the vaccine; This is Spontaneous report from a contactable Pharmacist . This Pharmacist reported similar events for two patients. This is a 2nd of 2 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient tested positive on their covid test, tested positive three days after receiving the vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021276371 Same reporter/events/ drug/diff patient

Other Meds:

Current Illness:

ID: 1151407
Sex: F
Age:
State: NJ

Vax Date: 01/25/2021
Onset Date: 03/12/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Tested positive via rapid and PCR on 13Mar for COVID even though fully vaccinated; Tested positive via rapid and PCR on 13Mar for COVID even though fully vaccinated COVID-19 PCR test; This is a spontaneous report from a contactable nurse. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Left on 05Jan2021 07:00 (Batch/Lot Number: EK9231) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 25Jan2021 (Batch/Lot Number: EL3Z47) as SINGLE DOSE for covid-19 immunisation. Medical history included Irritable Bowel Syndrome with constipation. There were no concomitant medications. Received both doses of the vaccine (1st dose 05Jan2021; 2nd dose 25Jan2021). Exposed to COVID on 10Mar2021, developed symptoms on 12Mar2021, tested positive via rapid and PCR on 13Mar2021 for COVID even though fully vaccinated. Health Department and testing center unable to hold specimen for variant testing. The events were assessed as serious (medically significant). The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 13Mar2021 Covid test type post vaccination=Nasal Swab, Covid test name post vaccination=Rapid Abbott Test,. The outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tested positive for covid-19, which is considered failure of COVID-19 vaccine BNT162B2, and the administration of BNT162B2.

Other Meds:

Current Illness:

ID: 1151408
Sex: F
Age:
State:

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: chills; sweat; pain; redness; swelling in the injections site; fever sensation; This is a spontaneous report from a non-contactable consumer, the patient. A female patient of an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she was administered with the second dose of the Pfizer's COVID-19 vaccine on Thursday, 11Mar2021 and that night she had chills, sweat, pain, redness and swelling in the injections site. The consumer reported that the redness, swelling and fever sensation continues until today and it has been 4 since the administration of the vaccine. The consumer finished the interaction saying that she was going to contact her physician. The patient had not recovered from the events, redness, swelling and fever sensation. Outcome of the events, chills, sweat, and pain was unknown. The lot number for the vaccine, BNT162B2, was not provided and has been requested.

Other Meds:

Current Illness:

ID: 1151409
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Dull pressing pain in the whole right side of his chest; Headache; Pain was radiating up his back and shoulders into his neck; Pain was radiating up his back and shoulders into his neck; Pain was radiating up his back and shoulders into his neck; Third night he started to shiver; he sweat a lot; This is a spontaneous report from a contactable consumer (patient) reported for a himself that. A male patient of an unspecified age received second dose bnt162b2 (Solution for injection) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose bnt162b2 (Solution for injection) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unknown date, the caller stated he had both doses of the vaccine. He stated he had a couple episodes of symptoms after the second dose. He had no problem with the first vaccine. 26 hours after the second shot he experienced dull pressing pain in the whole right side of his chest, kind of a pressure like on the lung spread over the whole area there. He took a TYLENOL and it went away and 10 days later had the same experience but it was the whole chest and the pain was radiating up his back and shoulders into his neck and he started having headache on an unknown date. He took a couple Tylenol and it went away but the next night had he same symptoms and the next couple nights he had the same symptoms and he took a couple Tylenol and went to bed. On the third night he started to shiver, like internal shivering and he couldn't get comfortable for about an hour and 15-20 min. Then he sweat a lot after that on an unknown date. At no time did he have a fever. He called the primary care physician and he suggested he call the cardiologist and had an appointment with him a couple days later. The next day he had symptoms again and he went to the Emergency Room and they performed tests as if he was having a heart attack, because he was having heart attack symptoms, and the tests were all negative. They were going to hold him over night but he had a stress test scheduled the next day so they let him leave and he had that test the next day and everything was negative and they couldn't find anything. Still when he wakes up he has the chest pain and they told him to still take Tylenol. The doctor prescribed nitroglycerin pills and nitroglycerin pain patches. He has not used any of those because the pain is not severe enough. He is reporting these but also wondering if other people have experienced these symptoms and he asked if it is possible that he got the side effects from the shot or is it a coincidence. The outcome of the events were unknown

Other Meds:

Current Illness:

ID: 1151410
Sex: F
Age:
State: OK

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: Started with rapid heart beats; Lungs sore; Headache; sore all around; Chest wall was painful; Weakness; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in right arm on 22Feb2021 05:00 (Lot Number: EN6203) at single dose for COVID-19 immunisation. Medical history included rapid heart beats control by medication, anxiety. Concomitant medications included metoprolol; alprazolam; and other vaccine (lot number: EL8982) received on 22Feb2021 in arm. The patient previously took codeine and experienced allergies; received bnt162b2 on 26Jan2021 (lot number: EN6203) in arm for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Started with rapid heart beats, lungs sore, headache, sore all around. Chest wall was painful. Weakness. Most of all systems went away, after the week of March12. Except the bad headache. They were still present. Events all started from 22Feb2021 05:00, resulted in Emergency room/department or urgent care. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Events were considered non-serious per reporter.

Other Meds: METOPROLOL; ALPRAZOLAM

Current Illness:

ID: 1151411
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/31/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: severe pain in her shoulder/ cannot use her right arm; couldn't use the right arm in range of motion; This is a spontaneous report received from a contactable consumer, the patient. A 61-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 as a single dose for COVID-19 immunisation. The patient medical history included bicep tendonitis. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced severe pain in her shoulder and couldn't use the right arm in range of motion. It was in her shoulder mostly and she couldn't raise her arm nor lift it. The patient had the first dose of the vaccine and experienced severe pain in her shoulder (not at the site but in her shoulder). In the range of motion, she couldn't use the right arm or work because of the pain. She could barely dress herself without screaming out in pain. In the past, in her other arm she has had bicep tendonitis and has taken naproxen due to inflammation. Treatment included ibuprofen (ADVIL) and icing it. Clinical outcomes of severe pain in her shoulder and couldn't use the right arm in range of motion were unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1151412
Sex: M
Age:
State: FL

Vax Date: 01/25/2021
Onset Date: 02/01/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: came down with the covid virus; came down with the covid virus; This is a spontaneous report received from a contactable consumer (patient). This 66-year-old-male patient reported that he received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced came down with the covid virus about 2 weeks after the vaccine in Feb2021 with outcome of unknown. MD told patient he should wait 90 days before getting the 2nd shot. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1151413
Sex: F
Age:
State: FL

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: tested positive a couple of days after 1st dose/SARS-CoV-2 antibody test: positive; tested positive a couple of days after 1st dose/SARS-CoV-2 antibody test: positive; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive a couple of days after 1st dose of the vaccine on Mar2021. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: positive on Mar2021. Outcome of events was unknown. Information on the lot/batch number is requested.

Other Meds:

Current Illness:

ID: 1151414
Sex: F
Age:
State: TX

Vax Date: 03/12/2021
Onset Date: 03/14/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Chest pain-radiating pain on right arm; Chest pain-radiating pain on right arm Went to the emergency room-14Mar2021; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eng199 and expiration date not provided) via an unspecified route of administration, administered in left arm on 12Mar2021 10:30 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient is not pregnant. The patient has no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) and ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1.5/30). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced chest pain-radiating pain on right arm on 14Mar2021 19:30 and went to the emergency room. The event resulted in Emergency room/department or urgent care. The patient underwent EKG, Chest X-Ray, Blood work on an unspecified date with unknown results. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.

Other Meds: PROZAC; BLISOVI FE 1.5/30

Current Illness:

ID: 1151415
Sex: F
Age:
State: KY

Vax Date: 02/06/2021
Onset Date:
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: A few days later Soreness and lump under arm receiving vaccine; A few days later Soreness and lump under arm receiving vaccine; This is a spontaneous report received from a contactable consumer (patient). A 64-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL9269), via an unspecified route of administration administered in left arm on 06Feb2021 at single dose for COVID-19 Immunization. Medical history included physical urticaria past 12 years. Concomitant medications included lisinopril from an unspecified date (several years) and ongoing for high blood pressure, and sertraline from 31Dec2020 and ongoing for anxiety. The patient previously took the first dose of bnt162b2 (Lot number/Expiry Date: EL3248) administered in right arm on 16Jan2021 at single dose for COVID-19 immunization and experienced warm feeling/Getting a warm feeling and changed to cooler clothing, used cool cloth sat under fan; itching; face was really swollen/face was really swollen and red, looked like sun burnt, skin was blotchy; broke out in hives on her face, arms, and chest; a few days later Soreness and lump under arm receiving vaccine; skin was blotchy/face was really swollen and red, looked like sun burnt, skin was blotchy, took quercetin to prevent hives, and took loratadine (CLARITIN)/famotidine (PEPCID) from 17Jan2021 to an unspecified date. Patient had a history of physical urticaria and had been taken the supplement quercetin for several years to prevent hives when warm, On 17Jan2021 patient began taken loratadine (CLARITIN)/famotidine (PEPCID) again instead of quercetin. Before taking second dose on 06Feb2021 the allergist advised that 2 days before, on 04Feb2021 patient took loratadine 3 x a day and continue famotidine 2 x a day. Her vaccine was scheduled for 11:20 am. Patient took one loratadine 08:00 am and one at 11:00 am. The pharmacist there advised that patient also take one diphenhydramine hydrochloride (BENADRYL) before her vaccine. Patient had no occurrence of hives with the second dose of vaccines. A few days later (2020) soreness and lump under arm receiving vaccine same for second vaccine on alternate arm. The adverse events did not require a visit to emergency room and physician office. Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021051378 same patient, different events on different dose of vaccine

Other Meds: LISINOPRIL; SERTRALINE

Current Illness:

ID: 1151416
Sex: F
Age:
State: CA

Vax Date: 01/31/2021
Onset Date:
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: had a "bad reaction"; wants to know the definition of anaphylaxis as that may be what happened; This is a spontaneous report. A contactable consumer (patient herself) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date were unknown), via an unspecified route of administration on 31Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, caller received first dose on 31Jan2021 and, on an unspecified date in 2021, the patient had a "bad reaction"; wants to know the definition of anaphylaxis as that may be what happened. Feels she was unable to get second shot because of reaction to the first. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1151417
Sex: M
Age:
State:

Vax Date: 03/02/2021
Onset Date: 03/01/2021
Rec V Date: 03/31/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: blood clots in his left legs and also some in his lungs.; blood clots in his left legs and also some in his lungs.; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that he had to go to the emergency room (ER) where they discovered blood clots in his left legs and also some in his lungs in Mar2021. The events were serious, the patient was hospitalized for 2 days. Therapeutic measures were taken as a result of the events and the patient was placed on blood thinners. The patient outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1151418
Sex: F
Age:
State: CT

Vax Date: 03/03/2021
Onset Date: 03/01/2021
Rec V Date: 03/31/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days; had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days; pain in abdomen and face/Abdominal pain; pain in abdomen and face; Generalized pruritus with skin rash; Respiratory distress; Angioedema (not hereditary); a lot of pain after her tooth extraction; Upper airway swelling; Cyanosis; Hoarse voice; Difficulty breathing; Sensation of throat closure; Generalized urticaria (hives); Generalized erythema; Generalized pruritus with skin rash; Localized injection site urticaria; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 15:00 (Lot Number: EN6199) (at the age of 72 years old) as single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD); osteoarthritis; rheumatoid arthritis (RA); allergy: Environmental; asthma. Concomitant medications included ubidecarenone (COQ10 [UBIDECARENONE]) ongoing; atorvastatin ongoing; nebivolol hydrochloride (BYSTOLIC) ongoing; methimazole ongoing. The patient was taking some medications prior to the event being reported. No prior vaccinations (within 4 weeks). The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than bnt162b2 prior to the event being reported. The patient had not received any other vaccines around the time of bnt162b2 vaccination. Caller would like to know if there was an impact on efficacy if she chooses to take her second dose of the Pfizer BioNTech COVID-19 vaccine at a later date than the recommended 21 days. Caller received her first dose of the Pfizer BioNTech COVID-19 vaccine on 03Mar2021. She stated that on 08Mar2021 she had a tooth extraction and was told by her physician to take Advil. Then on 11Mar2021 caller reported that she had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days. She stated that her physicians were unsure if it could have been a delayed reaction to the vaccine or a reaction to the Advil (which caller stated she had taken all her life) (lot number: 55633, Expiry Date: Feb2023). Caller was scheduled to receive her second dose of the vaccine next week and would like to know if she should take it. She stated one physician told her it was okay to do so while another told her to hold on taking it, so she was confused as to what to do. Reporter seriousness for Anaphylactic reaction was Hospitalization. The patient was in hospital for Anaphylactic reaction from 11Mar2021 to 14Mar2021. The patient stated she received her first COVID vaccine on 03Mar2021, and on 08Mar2021, she had a tooth extracted. Because of that, she was taking Advil on 11Mar2021, she had an anaphylactic reaction to the Advil and an acute hepatitis. And the doctors couldn't give her any answer. They didn't know what caused what and if it was a delayed reaction from the vaccine because it was one week following the vaccine or if it was just coincidental. The patient due next week (scheduled for 23Mar2021) for her second dose and wanted to know if she should she take it. She ended up in the hospital for five days. Date of hospitalization was 11Mar2021. Reason for hospitalization was Anaphylactic reaction. Date of discharge from the hospital was 14Mar2021 (pending clarification). Event "had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days" started from 11Mar2021 18:00. Seriousness Criteria: Hospitalization / Prolongation of hospital, hospitalized Duration of stay was 5d, event not recovered. The event required visit to Emergency Room. Treatment included steroids and fluids IV. "Tooth extraction" started from 08Mar2021 and treatment included Tylenol and Advil. Consumer stated she was still in a lot of pain after her tooth extraction (Mar2021). On 08Mar2021 she had a tooth extraction. After the procedure she had severe pain and she was taking Advil and by Thursday 11Mar2021 she had a lot of pain in abdomen and face. She went to ER 18:00 PM, she was going through a complete reaction. The patient required medical intervention: Corticosteroids, IV fluids. The patient was seen in the Emergency Department. The patient had hospitalized for 5 days. The patient was not admitted to an Intensive Care Unit. In Mar2021, the patient had Upper airway swelling, Respiratory distress, Cyanosis, Hoarse voice, Difficulty breathing (without wheeze or stridor), Sensation of throat closure, Generalized urticaria (hives), Generalized erythema, Angioedema (not hereditary), Generalized pruritus with skin rash, Localized injection site urticaria, Abdominal pain. No Bilateral wheeze/bronchospasm. No Stridor, No Increased use of accessory respiratory muscles, No Recession, no Grunting, no Dry cough, no Sneezing, No Rhinorrhea, No Shock, No Tachycardia, No Capillary refill time > 3 sec, No Decreased level of consciousness, No Loss of consciousness, No Generalized pruritus without skin rash, no Generalized prickle sensation, No Diarrhea, no Nausea, no Vomiting. Tachypnoea: Unknown. Measured hypotension: Unknown. Reduced central pulse volume: Unknown. The events did not require the initiation of new medication or other treatment or procedure. Lab work included Liver function over 10 000 in Mar2021. Patient's outcome following the potential anaphylactic reaction was Recovering. The outcome of the events "had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days", "a lot of pain after her tooth extraction" was not recovered, of "pain in abdomen and face" was unknown, of the other events was recovering.; Sender's Comments: Based on the temporal relationship, the association between the events anaphylactic reaction, hepatitis acute, and respiratory distress with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: COQ10 [UBIDECARENONE]; ATORVASTATIN; BYSTOLIC; METHIMAZOLE

Current Illness:

ID: 1151419
Sex: M
Age:
State: LA

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: covid test result positive; covid test result positive on 27Jan2021; arm is still sore where he got the shot; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3264), via an unspecified route of administration at arm left on 14Jan2021 11:00 am as SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation. Concomitant medications included atorvastatin calcium (ATORVASTATIN CALCIUM); metoprolol tartrate (METOPROLOL TARTRATE); apixaban (ELIQUIS). The patient experienced arm is still sore where he got the shot on 14Jan2021. It's a low-end, 1-2 on a pain scale. No other side effects from first shot. No side effects from second shot in right arm on 08Feb2021. The patient covid test (Nasal Swab) was positive on 27Jan2021. The patient underwent lab tests and procedures which included pain assessment: 1-2 on 14Jan2021, sars-cov-2 test: positive on 27Jan2021. The outcome of the events was unknown.

Other Meds: ATORVASTATIN CALCIUM; METOPROLOL TARTRATE; ELIQUIS

Current Illness:

ID: 1151420
Sex: F
Age:
State: MN

Vax Date: 02/12/2021
Onset Date: 02/15/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: blurry vision- right eye; BRVO; A localized clot (thrombus) development in a branch retinal vein.; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266) on 12Feb2021 02:15 PM in left arm at single dose for COVID-19 immunisation. Medical history included slight asthma, known allergies: sulfa, penicillin. No COVID prior vaccination. Concomitant medications included Vitamins (over-the-counter, other medications in two weeks). No other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) on 22Jan2021 03:30 PM in left arm at single dose for COVID-19 immunisation at the age of 67-year-old. The patient was not pregnant, was not pregnant at time of vaccination. No COVID tested post vaccination. On 15Feb2021, within a few days of receiving second dose of vaccine, the patient developed blurry vision of right eye. After seeing a retina specialist, patient was diagnosed with BRVO (retinal vein branch occlusion). The cause of BRVO is a localized clot (thrombus) development in a branch retinal vein. The events resulted in disability or permanent damage. The patient received treatment as anti-VEGF drug - Avastin for the events. Outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1151421
Sex: F
Age:
State:

Vax Date: 02/06/2021
Onset Date: 02/01/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: She found out she has covid before the second dose/her mom tested negative, but still has symptoms like stuffy nose, shortness of breath and wheezing, she is taking prednisone 10 mg; stuffy nose; shortness of breath; wheezing; She found out she has covid before the second dose; This is a spontaneous report from a contactable consumer. A female patient (Age: 84; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was due for her second dose on 27Feb, but she found out she has covid before the second dose. Patient did not received her second dose. Caller stated her mom tested negative, but still has symptoms like stuffy nose, shortness of breath and wheezing, she is taking prednisone 10 mg. caller wanted to know when she will be able to take her second dose. Outcome was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1151422
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Came down with covid.; Came down with covid.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had received 1st dose of covid vaccine. Came down with covid. 2nd dose of vaccine due next week. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1151423
Sex: M
Age:
State:

Vax Date: 02/25/2021
Onset Date:
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: blood pressure had increased after taking the first dose of the Pfizer COVID-19 vaccine / blood pressure has been high as 178/102; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 via an unspecified route of administration on 25Feb2021 (Batch/Lot number and expiration date were not reported) as single dose for covid-19 immunisation. The patient medical history included blood pressure dropped lower. Patient went to see a doctor who's not his regular doctor because his blood pressure (BP) dropped lower than it should. The doctor lowered his BP dose. Patient was currently taking a couple of medications which may have caused this fluctuation in his blood pressure. His blood pressure had increased after taking the first dose of BNT162B2 on 25Feb2021. His blood pressure had been high as 178/102. Normally his blood pressure came back to normal within a week but it was not coming down this time around. He would go see his regular doctor now. The outcome of event was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1151424
Sex: F
Age:
State: MN

Vax Date: 03/08/2021
Onset Date: 03/12/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Bells Palsy; runny nose; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Mar2021 11:30 (Batch/Lot Number: EN6199) as single dose for covid-19 immunisation. Medical history included diabetic, arthritis, torn right shoulder, neuropathy plantar fasciitis arthritis back pain, allergies: sulfa, antibiotics, indomethacin, amoxicllin, sulfacetamide. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication from an unspecified start date and ongoing; allopurinol (ALLOPURINOL) taken for an unspecified indication from an unspecified start date and ongoing; atenolol (ATENOLOL) taken for an unspecified indication from an unspecified start date and ongoing; fluoxetine (FLUOXETINE) taken for an unspecified indication from an unspecified start date and ongoing; diclofenac (DICLOFENAC) taken for an unspecified indication from an unspecified start date and ongoing; furosemide (FUROSEMIDE) taken for an unspecified indication from an unspecified start date and ongoing; metformin (METFORMIN) taken for an unspecified indication from an unspecified start date and ongoing; pregabalin (PREGABALIN) taken for an unspecified indication from an unspecified start date and ongoing; simvastatin (SIMVASTATIN) taken for an unspecified indication from an unspecified start date and ongoing; levothyroxine sodium (SYNTHROID) taken for an unspecified indication from an unspecified start date and ongoing; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication from an unspecified start date and ongoing; amitriptyline (AMITRIPTYLINE) taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced bells palsy on 12Mar2021 with outcome of not recovered, runny nose on 12Mar2021 with outcome of recovering. Clinical course: the consumer said that the Bell's palsy started Friday with a runny nose, her right side nostril. She said Saturday she had it where she can't move the right side of her face properly, and that is when she called to make her doctor's appointment for this morning. The reported events required visit to: Physician office. The patient received prednisone 1 daily for 7 days as treatment for the event Bells Palsy.

Other Meds: TYLENOL; ALLOPURINOL; ATENOLOL; FLUOXETINE; DICLOFENAC; FUROSEMIDE; METFORMIN; PREGABALIN; SIMVASTATIN; SYNTHROID; VITAMIN D NOS; AMITRIPTYLINE

Current Illness:

ID: 1151425
Sex: F
Age:
State: NY

Vax Date: 02/14/2021
Onset Date: 02/16/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

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

Other Meds: DIOVAN; PREMARIN; SYNTHROID; PRAVASTATIN; VIT D3; FAMO

Current Illness:

ID: 1151426
Sex: M
Age:
State: TX

Vax Date: 02/22/2021
Onset Date: 03/12/2021
Rec V Date: 03/31/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Fell out of bed; tonic clonic seizure; postictal (confusion); This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 22Feb2021 10:15 (lot number: EN6203) as single dose for COVID-19 immunisation. The patient's medical history included hypertension. The patient's concomitant medications included losartan and OTC vitamin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Jan2021 03:45PM (lot number: EL9262) for COVID-19 immunisation. On 12Mar2021 06:30, the patient fell out of bed and wife witnessed tonic clonic seizure of 5+ minutes. And when EMS arrived on 12Mar2021 06:30, the patient was postictal (confusion). The events resulted to Emergency Room visit and patient was hospitalized for 3 days. The patient had no COVID prior vaccination and was tested for COVID post vaccination. The patient underwent lab tests and procedures and included blood test and scan, both with unknown results on an unspecified date and nasal swab/NAAT: negative on 12Mar2021. Therapeutic measures were taken as a result of the events and included numerous scans, blood tests and levetiracetam. The vaccination facility type was hospital. The outcome of the events were recovered with sequel.

Other Meds: LOSARTAN

Current Illness:

ID: 1151427
Sex: F
Age:
State: FL

Vax Date: 03/07/2021
Onset Date: 03/08/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: severe hair loss/On the left side of my head I had the bald spot 4 cm in diameter bald no hair; physiological traumatic; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6199), via an unspecified route of administration, administered in the left arm on 07Mar2021 14:15 (at the age of 56 years old) at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included type 1 diabetes, psoriasis and sensitive immune system, all from an unknown date and unknown if ongoing. The patient was not pregnant. There was no other vaccine in four weeks. There were no known allergies. Concomitant medications included insulin taken for type 1 diabetes mellitus, start and stop date were not reported. The patient experienced severe hair loss/on the left side of my head i had the bald spot 4 cm in diameter bald no hair and physiological traumatic, both on 08Mar2021 07:30. It was reported that after the vaccination, on 08Mar2021, the patient had severe hair loss and now she has a bald spot of 4 centimeters. The patient's hair started falling out but she didn't think much of it, from time you brush your hair it just happens but as the day progressed they just kept falling out and she had very thick bulky hair and she didn't even look the same and on the left side of her head which was weird because that was the side where she got the shot, on the left side of her head , she had the bald spot 4 cm in diameter bald no hair. Her hair still continues to fall and she can't brush it or touch it because it becomes more severe. As the day progressed, they just kept falling out. This was emotionally, it's horrible, it's like losing part of her body. No treatment was received. She doesn't even know what to do, she went to the doctor today to talk to them about that and then she was going to the dermatologist on Thursday, She never had that in her life. Today is 16Mar2021, and her hair was still falling. It was also reported that she is looking for justice since this is physiologically traumatic. She was scared to wash her hair. It was reported that the events resulted in disability/permanent damage. No treatment was received. There was no COVID prior vaccination and not COVID tested post vaccination. The patient underwent lab tests and procedures which included Hemoglobin A1-C: 6.2 (average blood sugar is 6.2) on an unspecified date. The outcome of the events was not recovered.

Other Meds: INSULIN

Current Illness:

ID: 1151428
Sex: M
Age:
State:

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: joint pain; feels dizzy; weak; drowsy; slight headache; feels like a zombie; stomach is expanding and he has lost six pounds; covid blahs; This is a spontaneous report received from a contactable consumer (patient reported himself). A 73-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection) via an unspecified route of administration three weeks ago on an unspecified date in Feb2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller stated that he had the first Pfizer Covid 19 vaccine three weeks ago. Caller stated that he had joint pain the first day only. Caller reports that ever since he got the vaccine, he felt dizzy, weak, drowsy and has a slight headache and stated he felt like a zombie like he drank a six pack of beer the night before. Caller stated his HCP said he had the Covid blahs. Caller stated his stomach was expanding and he had lost six pounds. Caller stated that it feels like he had Covid again every morning. Caller stated he felt normal before the vaccine. Caller stated that he was afraid to get the second shot wanting to know if his reaction would be considered a contraindication and will the second dose be worse. Caller was number four in the queue and did not want to hold. AE noted. Outcome of the events was unknown. No PQC Present. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1151429
Sex: M
Age:
State: NY

Vax Date: 03/14/2021
Onset Date: 03/14/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: sore throat; nasal congestion; very difficult to breath; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 14Mar2021 16:00 as SINGLE DOSE for covid-19 immunisation. There was no other vaccine in four weeks. No known allergies. The patient medical history was not reported.Concomitant medications included atorvastatin and Irbesartan, both taken for an unspecified indication, start and stop date were not reported. The patient started with sore throat that got progressively worse and nasal congestion. The 2 combined made it very difficult to breath. The events onset date were reported as 14Mar2021 05:15 PM, they resulted in Emergency room/department or urgent care. Patient received Benadryl, Pepcid and IV for treatment, and recovered in Mar2021. Patient didn't have Covid prior vaccination nor teasted Covid post vaccination. Information about lot/batch number has been requested.

Other Meds: ATORVASTATIN; IRBESARTAN

Current Illness:

ID: 1151430
Sex: F
Age:
State: FL

Vax Date: 03/05/2021
Onset Date: 03/10/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: She was exposed to COVID virus on 10Mar2021 but has no symptoms; This is a spontaneous report from a contactable 56-Year-old female consumer (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 05Mar2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated she received the first dose of vaccine on 05Mar2021. She was exposed to COVID virus on 10Mar2021 but has no symptoms. Her second dose has been scheduled on 27Mar2021. The patient planned to follow-up with her vaccination provider for further discussion. She was ok with further follow-up. No additional details available. Information on lot/batch number is requested.

Other Meds:

Current Illness:

ID: 1151431
Sex: F
Age:
State: NY

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: After the nurse said old gee and kept wiping my arm; It went up to about 180, 190 even 200 over 80; The test results shows that I have no antibodies; Anxiety; This is a spontaneous report received from a contactable consumer for herself. The consumer reported the similar events for the patient with different dose. This is the second of two reports. This 81-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT: EL9266), via an unspecified route of administration administered in left arm on 26Feb2021 as single dose for COVID-19 immunization. Medical history included cholesterol. The patient was taking medication for her cholesterol. The patient received the first dos of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL9264) on 26Feb2021 in left arm for COVID-19 immunization and after the first dose about 8 days later, her blood pressure went up very high. Its normally never get that high. It went up to about 180, 190 even 200 over 80 and then she saw her physician was put on some blood pressure medication, and she got better. When the patient received the first dose, she have a headache and was slightly nauseous. Then the patient had her second vaccine. After that the same thing happen about a week later. her blood pressure went very high (went up to about 180, 190 even 200 over 80), and she suffered because of it with a lot of anxiety in 2021. The patient want to know something about that the blood pressure went really very high. It was still not regular; it was very irregular. When she went for the second dose, she did not even looked when the nurse was putting a needle in her arm so, she felt that the needle went in but shortly after she heard the nurse said oh jeez and she know the nurse put it right in her arm. Shortly after the nurse said old gee and kept wiping her arm. Later she noticed the nurse had a gauze under the band aid. The patient thought maybe she was bleeding, she did not have a look, she ended up with a bandage over it and that was it, other day she see it did not have any blood on it. And she wondering if she got the full dose of the second vaccine, she had absolutely no side effects immediately after over the next day. Also, she took a test for antibody and that came out negative in 2021. She was still experiencing the high blood pressure after the second vaccination as well. The physician had prescribed the medication for blood pressure went very high with losartan 75 mg. The outcome of blood pressure went very high was not recovered. It's over. It's between a 140-150. The outcome of other events was unknown. No follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021299032 same patient/drug, different dose/event

Other Meds:

Current Illness:

ID: 1151432
Sex: M
Age:
State:

Vax Date: 02/25/2021
Onset Date: 03/04/2021
Rec V Date: 03/31/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: tested positive for COVID-19; tested positive for COVID-19; Hypokalemia; This is a spontaneous report from a contactable physician. This physician reported for an 85-year-old male patient (friend's father) that who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The physician asked about timing of the second vaccine dose following positive COVID infection and use of monoclonal antibody therapy. Physician reported that the patient received his first dose on 25Feb2021. Following vaccination he tested positive for COVID-19 on 04Mar2021. He saw his doctor and was sent to the hospital for monoclonal antibody infusion on 05Mar2021. On 08Mar2021 he went back to the ER with Hypokalemia. And on his follow up appointment with his doctor on 15Mar2021, the doctor said that he can't receive his second dose until 90 days after the first. Physician reported that he read somewhere about the second dose being up to 42 days after the first and requests clarification in this circumstance. Lab data included patient tested positive for COVID-19 virus test on 04Mar2021. Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: The possibility that suspect drug may have contributed to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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. ~

Other Meds:

Current Illness:

ID: 1151433
Sex: F
Age:
State: FL

Vax Date: 03/01/2021
Onset Date: 03/05/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: pain and discomfort in the arm; tiredness; fogginess in her mind; i cannot sleep; heart palpitations; feeling that something is dislodged from my left breast/sensation of dislode in her left breast; breast pain; pain was acute but worsens when she lays horizontally in bed and when she bends like when getting something in the refrigerator; This is a spontaneous report from a contactable 64-year-old female consumer and other health care professional reported that. A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on Mar2021 7:00 PM (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation. Medical history included diverticulum. patient received other medications within 2 weeks of vaccination were multiple vitamins and melatonin. Patient was not pregnant at the time of vaccination. Patient was not received treatment for the adverse event. Patient was not Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient was allergic to Penicilline. Caller got the first dose of the Pfizer COVID-19 vaccine on 03Mar2021. After getting vaccinated, she developed pain and discomfort in the arm in which she thought it was normal. Two days after vaccination, on 05Mar2021, the pain increased and it extended to her underarm, her left breast, her neck, and her back. She said the pain was acute but worsens when she lays horizontally in bed and when she bends like when getting something in the refrigerator. She also has a sensation of dislode in her left breast. She mentioned that was vaccinated in her left arm. She said that she didn't have fever, but she experienced a little bit of tiredness and also fogginess in her mind. She said her main concern is the pain in her arm that extends to her breast and underarm. She wanted to know if this is a reported adverse event with the Pfizer COVID-19 vaccine. First only pain & discomfort in the arm, but 2 days, after the pain increased and extended underarm, axil and is particularly SUPER-ACUTE in the left breast, to the point that i cannot sleep. Also have heart palpitations, difficulty raising the arm, plus the feeling that something is dislodged from my left breast. The horizontal position in bed is the worst for the breast pain. For the record I have never had any pain in the armas & breasts before I received the Pfizer vaccine on March 3rd. I am very concern. I am scheduled to revive the 2nd. shot in Mach 26th. but before I need to get an explanation of my side effects, how dangerous they are, what to expect, and the assurance that I can safely receive the second dose of Pfizer Covid-19 vaccine. Outcome of the events were not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021289248 Pfizer

Other Meds:

Current Illness:

ID: 1151434
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: arm was sore in the evening; so painful; 1.5 inch scratch where he tried to inject her; questioning if it all got in her and out of the syringe; This is a spontaneous report from a contactable consumer (the patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing autoimmune disease. The patient's concomitant medications were not reported. On an unspecified date the patient arm was sore in the evening, so painful, 1.5 inch scratch where nurse tried to inject her, questioning if it all got in her and out of the syringe. Caller reported she received the first dose of the Pfizer-BioNTech COVID-19 vaccine. She specified the vaccine was administered through a drive-through and she was sitting on the passenger seat. She explained the "nurse guy was standing outside" and didn't notify her before injecting the vaccine, therefore she "flinched" when she got it. She specified she "probably move" and "he jabbed [her] twice. She added the nurse checked the syringe to see how much of the vaccine was administered and "he thought he got it all out". She explained "he couldn't tell where he had injected" to put the band-aid. She further explained when she took out the band-aid, she noticed "1 inch and 1/4" of what appeared as a "needle scratch". She later described the size of the scratch as "1 inch and 1/2". She then mentioned her "arm was sore in the evening" and a little bit the next day. She said she called the pharmacist who said her soreness was due to the vaccine and not the needle. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness: Autoimmune disorder

ID: 1151435
Sex: F
Age:
State:

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: losing her sight; headache; blood pressure started fluctuating up and down; heart palpitations; atypical migraines; felt terrible; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205; Expiration Date: Jun2021), second dose via an unspecified route of administration on 26Feb2021, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201; Expiration Date: Jun2021) on an unspecified date for covid-19 immunisation. Historical vaccines include flu shot and got the flu, shingle vaccine and got shingles. Patient does not remember when she got the first vaccine but about 3 days after the second one (2021), she started getting headaches. She has atypical migraines where she just gets the eye symptoms but never gets headaches. She had some of the atypical migraines as well. Her blood pressure started fluctuating up and down and she had heart palpitations. She saw her doctor who did an EKG which didn't show any heart attack. She just felt terrible. The symptoms lasted about a week or a little over a week and it has now all gone away and she feels like herself. When trying to read lot numbers, caller said she is losing her sight. The outcome of the event vision loss was unknown, other events was recovered on 2021.

Other Meds:

Current Illness:

ID: 1151436
Sex: F
Age:
State: NY

Vax Date: 02/06/2021
Onset Date:
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: After I got the first dose, I experienced fever, headaches, sore arm; After I got the first dose, I experienced fever, headaches, sore arm; After I got the first dose, I experienced fever, headaches, sore arm; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264), via an unspecified route of administration, administered in left arm on 06Feb2021 at 16:30 (at age of 57 years old, no pregnant at vaccination) at a single dose, for COVID-19 immunization. Medical history included Known allergies: food reactions to shrimps, crabs, lobsters- and occasionally to pineapples, avocado and eggs; also had reactions to penicillin, sulfa- type medications. Other medical history: none. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. After the patient got the first dose, she experienced fever, headaches, sore arm-however they went away in a couple of days. The outcome of the events was recovered.

Other Meds:

Current Illness:

ID: 1151437
Sex: F
Age:
State: TX

Vax Date: 03/10/2021
Onset Date: 03/11/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Left arm did not have any feeings when I woke up in middle of the night; Chills; Fever 101.0; Body aches in both knees; Sore right arm; This is a spontaneous report from a contactable consumer (Patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6206), via an unspecified route of administration in the right arm on 10Mar2021 at 09:15 for COVID-19 immunization. The patient was not pregnant. Medical history included Hypertension. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EI9267) in right arm on 19Feb2021 for COVID-19 immunization. The patient received other medication in two weeks. On 11Mar2021 at 03:00 AM, the patient experienced chills, fever 101.0, left arm did not have feelings at night, body aches in both knees and sore right arm. The patient did not receive any treatments for the events. The clinical outcome of chills, fever 101.0, left arm did not have feelings at night, body aches in both knees and sore right arm was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1151439
Sex: F
Age:
State: WI

Vax Date: 02/18/2021
Onset Date:
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

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

Other Meds: LOSARTAN

Current Illness:

ID: 1151440
Sex: F
Age:
State: CA

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 03/31/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: cardiac arrhythmia; dizziness/lightheadedness; nausea; muscle weakness; extreme fatigue; lost consciousness/She is in and out of consciousness; extreme weakness; extremely low blood pressure; tachycardia when resting/heart rate is high/HR gets up to 135; One foot and leg became very cold and turned blue; One foot and leg became very cold and turned blue; other foot warm and hot; This is a spontaneous report from a contactable consumer (patient's sister). A 30-year-old non-pregnant female patient received the second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EN/ EW 6198; expiration date: unknown), at vaccination age of 30-year-old via an unspecified route of administration in the left arm on 02Mar2021 as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not diagnosed with covid prior to vaccination. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EN6198), at vaccination age of 30-year-old via an unspecified route of administration in the left arm on 09Feb2021 as a single dose for covid-19 immunisation but had weakness, fainted, lost consciousness and concussion. There were no concomitant medications. The patient did not receive other vaccine in four weeks. The reporter mentioned that on the next day after vaccination (03Mar2021), the patient's one foot and leg became very cold and turned blue other foot warm and hot started cardiac arrhythmia, dizziness, lightheadedness, nausea, muscle weakness, extreme fatigue, extremely low blood pressure and tachycardia when resting. The reporter stated that since 02Mar2021, she hasn't been able to get out of bed due to extreme weakness. The reporter also mentioned that her heart rate (HR) gets up to 135 [unit unspecified]. The reporter also stated that the patient was wearing a heart monitor and was waiting for data. They went to the emergency room (ER) on 12Mar2021 due to concerns of blood clot, ruled out blood clot. The doctors can't explain what is happening to her. She was extremely healthy and fit, no previous cardiac or energy issues. No blood pressure issues or family HX. She says she "feels like she's dying". The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and life-threatening illness (immediate risk of death from the event). The hospitalization was reported as 1 day. It was unknown if the events received treatment. The patient was not tested post vaccination. It was further reported that her sister had the second Covid shot 02Mar2021 and a few hours later she lost consciousness. She has been in the hospital ever since. She was in and out of consciousness, her blood pressure is low, and her heart rate is high. One of her legs is blue and cold, the other is hot. She cannot get out of the bed. The doctors don't know what is wrong. It was mentioned that the patient was healthy and not taking any medication. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1151441
Sex: F
Age:
State: PA

Vax Date: 02/07/2021
Onset Date: 03/10/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: She was been down for over a week, the Covid symptoms; weakness of bones; nauseous; headaches; she missed the 2nd dose; Tested positive for COVID; Tested positive for COVID; sick; This is a spontaneous report from a Pfizer Sponsored Program. Two contactable consumers (patient's husband and patient herself) reported that a 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 07Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14Mar2021, the patient tested positive for COVID, sick, she missed the 2nd dose, weakness of bones, nauseous, headaches, serious side effects and she was been down for over a week, the COVID symptoms on an unspecified date. He does not have any adverse reaction at all. The report was received as, he does not have any adverse reaction at all. The reason for call is not for him personally. It is for his fiance. For the first dose, he had his dose on 14Mar2021. Prior to that first dose, 3 weeks before that, is when he had first dose. She and him went together for first dose. She has one dose and had to go back to her hometown for a family emergency and was not able to go for second dose. In the interim, she got a COVID test and she tested positive. She did not come for second shot or they would have gone together. What does she have to do after testing positive and missing her second dose? He was going to have her call directly. He said she has all the information about what they used and what protocol for test she took. Reporter stated, "Well I have a situation. My wife and I on 7Feb2021 got our 1st dose. In the interim she had to go out of town to her family and she tested positive after her 1st dose. My question is, I went and had my 2nd dose on 14Mar2021. I got mine, but she didn't get hers. She would like to know, how long she had wait before she gets the 2nd dose." Reporter stated, "Since I have you on the phone you can get the side effects. She had serious side effects. She was been down for over a week, the Covid symptoms. She is not asthmatic. She had weakness of bones, nauseous, headaches no fever or coughs but all the other symptoms." She may be taking thyroid medications. That's all I know. Reporter stated, "I hope I don't have to go on hold for another 2 hours and 45 minutes." The doctor's don't know. She is recovering. I already spoke with the safety team and reported this.: Spoke from attached document and emailed as requested Spoke from (LAB- 1457-6.0 Revised: 25Feb2021) under section 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA "The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19." Therapeutic measures were taken as a result of she was been down for over a week, the COVID symptoms, sick, weakness of bones, nauseous, headaches and serious side effects with reported as, she is taking some vitamins. The patient underwent lab tests and procedures which included COVID-19 test: positive on 14Mar2021. The outcome of events was recovering. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1151443
Sex: F
Age:
State: TX

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 03/31/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; Dilated cardiomyopathy; fever; chills; vomiting; severely low potassium; fluid build up around her heart and lungs; fluid build up around her heart and lungs; This is a spontaneous report from a contactable consumer (patient's husband). A 49-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location; Arm) on 22Jan2021 13:00 as SINGLE DOSE for COVID-19 immunisation. Patient's medical history was not reported. Concomitant medication included biotin from an unspecified date and unknown if ongoing. The patient previously took 1st dose of the Pfizer COVID Vaccine on 29Dec2020 (around 10:00 am to 12:00 pm at a hospital) and had the usual side effects of a little bit of nausea, developed a dry cough, some fatigue, and diarrhea and that kind of stuff. The reporter called about the Pfizer COVID vaccine and was calling on behalf of his wife who was the patient. Reporter stated that before the Pfizer COVID vaccine, patient used to walk the dogs 6 miles a very fast pace and had no problem, then she got her 1st dose of the Pfizer COVID vaccine on 29Dec2020 and had the usual side effects of a little bit of nausea, developed a dry cough, some fatigue, and diarrhea and that kind of stuff. The reporter stated that after the 1st dose of the Pfizer COVID vaccine, the symptoms she reported have worsened and the cough, fatigue, nausea, and diarrhea began immediately after the 1st dose of the vaccine where the cough started a week or so after the 1st dose and then after the 2nd dose, the cough never went away and got worse and worse and worse. Reporter stated the fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse. Reporter mentioned that for the cough after the first dose of the Pfizer COVID vaccine, it was still there but was occasional and was not too bad but when the patient had the 2nd dose on 22Jan2021 and was knocked on her butt for about three days; also stated that the patient had fever, chills, diarrhea, vomiting, nausea and the works and had all the symptoms. It was also reported that the patient was very sick for 3-4 days with same symptoms. Reporter mentioned that fatigue was getting worse and the cough never went away and always had the dry cough which was getting worse and worse and worse with any activity and was a dry cough and she never had any phlegm. Reporter also stated the patient got to where she did less and less activity and was worse and the dry cough was worse with nothing coming up. It was reported that the patient sought treatment for everything she believed last week on Monday but was unsure of the dates. Monday of last week, patient went to the emergency room in a hospital and was told that they thought that the patient had an enlarged heart and severely low potassium and the patient was put on an IV drip of potassium because she could not tolerate the oral potassium and threw up the oral potassium so she was put on two bags of IV potassium. On an unknown date, it was reported that patient started having pain in her chest from the IV drip of potassium but she was released from the emergency room and the 2nd day of last week which was the next day, patient went back to the emergency room because she was having issues and everything was getting worse. Reporter also stated that the 2nd of last week, the patient collapsed and an ambulance came and got her on Tuesday of last week though reporter was unsure of the dates. Reporter also mentioned that patient went to a hospital and had severe chest pain and collapsed pressure on her chest. Reporter stated that the patient at that time had the dry cough and stuff and the hospital told the patient that the patient had fluid build up around her heart and lungs which was maybe due to the treatment from the IV potassium and was told she has a weakened heart. It was reported that with a weakened heart, the heart can't process fluid around the lungs and the heart and it puts pressure on heart supposedly. It was reported that on Wednesday last week, the patient went to the emergency room for the 3rd day in a row and already had an appointment with the HCP which was an appointment with her new primary Nurse Practitioner for the first appointment and she confirmed that the patient had fluid on the lungs when she saw the patient. Reporter stated that the nurse practitioner could not admit the patient because the hospital she admits too was full so she sent the patient to a hospital emergency room where they did all the tests and everything confirmed what they said and they transferred the patient to another hospital where the patient stayed in the hospital a total of three days and was diagnosed with cardiomyopathy and they started treatment on the patient. The patient was started on Entresto later on and tomorrow there was a follow up visit with her primary HCP and they have to follow up because the patient was released from the hospital and was very weak and she has to wear a lifevest because she is a heart patient and has a weak heart. It was reported that patient is going to be taking medications and stuff and will go see the HCP and they gave her beta blockers and other stuff and she will follow up with the HCP. It was reported that any of the medications including the beta blockers the patient was taking, reporter has no names of the medications, dosages or lot numbers or other information to provide at this time and stated that the patient was treated with those medications in the hospital and that was the hospital in another city and state. Reporter mentioned that it was last week when the patient collapsed while trying to walk across the yard and she was diagnosed with dilated cardiomyopathy where part of the heart shrunk which is the expelling chamber of the heart and the HCP stated where a normal 20-30 year old would have heart function of 55, the patient had an output of 15. Reporter stated that the HCP said that stroke, disease or things like that can cause cardiomyopathy and there are various things that can cause it but they can't diagnose what caused this in the patient because she has not had various things and the only she had was the Pfizer COVID shots that hit her very hard and she just turned age 50. Reporter stated that the patient was age 49 at the time she began experiencing the symptoms that were reported and just turned age 50. Reporter clarified to state the potassium drip the patient had was not at this hospital but was at another hospital. Reporter stated he has no lot numbers, expiry dates or NDC numbers to provide as he does not have the patient card for the Pfizer COVID Vaccine that the patient received and that paperwork is with the patient who is staying at her sister's house so the sister can help monitor the patient. Reporter also mentioned that patient was not taking medications at the time she received the Pfizer COVID Vaccine at that time but was taking over the counter Biotin and states he has no lot, expiry date or UPC to provide. Reporter mentioned that patient has no family history of heart conditions but he thinks the patient's mother is diabetic but she is the only who is diabetic and there is no other history he is aware of. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds: BIOTIN

Current Illness:

ID: 1151444
Sex: F
Age:
State: SC

Vax Date: 03/04/2021
Onset Date: 03/07/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

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

Other Meds: PANTOPRAZOLE; ESCITALOPRAM; CLONAZEPAM

Current Illness:

ID: 1151445
Sex: F
Age:
State: SC

Vax Date: 03/02/2021
Onset Date: 03/01/2021
Rec V Date: 03/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: had her 1st dose of the vaccine last March 2, 2021 and tested positive for Covid after the 1st dose; had her 1st dose of the vaccine last March 2, 2021 and tested positive for Covid after the 1st dose; This is a spontaneous report received from a contactable consumer via Pfizer sponsored program for a herself. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 02Mar2021 at SINGLE DOSE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient stated had her 1st dose of the vaccine last 02Mar2021 and tested positive for Covid after the 1st dose. It would be her last day of quarantine and she was scheduled to take the 2nd dose on 17Mar2021. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm