VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1004370
Sex: F
Age:
State: TX

Vax Date: 01/14/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
Hospital: Y

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Symptoms: trouble breathing/couldn't breathe without oxygen; possible COVID-19 pneumonia; possible COVID-19 pneumonia; wouldn't eat; incoherent; thrashing around with her legs, would not settle down/legs were thrashing around; persistent UTI; aspiration pneumonia; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for the mother. A 90-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech) (lot# EL3249), intramuscular in right upper arm, on 14Jan2021 between 12:00 PM to 12:30 PM , at single dose, for COVID-19 immunisation. She was monitored for an hour after vaccine. Medical history included penicillin allergy, ongoing vascular dementia, cardiac pacemaker insertion, congestive heart failure. There were no concomitant medications. The patient previously took ciprofloxacin and experienced drug hypersensitivity and rash (she took the prescribed dose and immediately broke out after, all over her body), codeine and experienced drug hypersensitivity, neomycin and experienced drug hypersensitivity, neosporine and experienced drug hypersensitivity. The patient experienced aspiration pneumonia in Jan2021 with outcome of unknown, wouldn't eat on 17Jan2021 with outcome of unknown, trouble breathing/couldn't breathe without oxygen on 21Jan2021 with outcome of unknown, incoherent on 15Jan2021 with outcome of unknown, thrashing around with her legs, would not settle down/legs were thrashing around on 15Jan2021 with outcome of unknown, persistent urinary tract infection (UTI) on an unspecified date in Jan2021 with outcome of unknown. The events were considered serious as caused patient's hospitalization. Clinical course: on 15Jan2021 night the patient started thrashing around with her legs, would not settle down, she was incoherent. On 17Jan2021, when she woke up, she was completely incoherent and would not eat. On 17Jan2021 she was taken to the emergency room (ER), and was diagnosed with aspiration pneumonia and persistent urinary tract infection (UTI). The patient was admitted on 17Jan2021 and she was treated. On 18Jan2021 patient got better, they put her on a bunch of antibiotics. On 19Jan2021 patient walked the halls, she wasn't incoherent. She was going to get PT/OT, speech therapy. The patient was discharged on 20Jan2021 and was taken to rehab type place (near the hospital), she was fine. However over the night she got worse. She became incoherent again and couldn't breathe without oxygen (21Jan2021). On 21Jan2021 the patient was sent back to ER due to trouble breathing. The reporter stated that something happened at nursing home and the patient went bonkers. She was admitted again (still ongoing) and put to intensive care unit (ICU) for treatment. The patient underwent lab tests and procedures which included cardiac function test: nothing wrong with heart in Jan2021, chest x-ray: concerning for possible Covid pneumonia on 17Jan2021 (transvenous pacemaker is present some peripheral, increased entity present Concerning for possible COVID pneumonia), CT scan: no evidence of pleural effusion or pneumothorax in Jan2021, COVID-19 virus test: negative in Jan2021 (2 times during the ER trips). Therapeutic measures were taken as a result of the events and included treatment with unspecified antibiotics.

Other Meds:

Current Illness: Vascular dementia

ID: 1004371
Sex: F
Age:
State: NC

Vax Date: 01/18/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
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Symptoms: she did not feel totally right; some high blood pressure; she has an irregular heart beat; This is a spontaneous report from a contactable consumer (patient). The 77-years-old female patient received first dose of BNT162b2 (BNT162B2, lot number: EL3248), via an unspecified route of administration on 18Jan2021at SINGLE DOSE for covid-19 immunisation. Medical history included diagnosis of irregular heart rate prior to the vaccine, about 4-5 years ago, allergy, Cholesterol. The patient experienced some high blood pressure on Jan2021, she has an irregular heart beat on Jan2021. "I developed some high blood pressure after getting the vaccine." she has developed a very high blood pressure reading and that is unusual for her, states she went to a walk in clinic on Tuesday and then to the doctor today. Caller states that it really concerns her that someone who is medically savvy as she could have a serious problem. stated that she did not feel totally right while she was waiting afterwards, states that she came home and laid around and the next morning, she can tell when it is high because she is chronically low. Caller states the next morning the top number of her blood pressure was 166, states bottom number is never out of sync (AS REPORTED). Caller states she could feel it really bad yesterday, really bad states she took the pressure once and it was 182/94 and a little later it was 192/84 and that is when she went to the walk in clinic. Caller states she has an irregular heart beat and she takes a blood pressure medication to treat that, takes 25mg once a day at night time. Yesterday morning she took another one before she went to the walk in clinic to help treat the high blood pressure, so she had 50 mg in 12 hours; when she got there they checked it and it was 178/72. She also takes an allergy medication and something for cholesterol that she has been taking for years. She called on 21Jan2021 around 5pm regarding the Pfizer covid vaccine. She called because she was having blood pressure issues and two different doctors thought it was covid vaccine related. It has taken since then till today to get a reasonable blood pressure. Her thoughts are not to get the second dose. She is asking if she will have any protection if she does not get the vaccine and if there will be any adverse effects if she goes not get the second vaccine. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness:

ID: 1004372
Sex: F
Age:
State:

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/05/2021
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Symptoms: Fever; 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: EL1283; Expiration Date: Apr2021), via an unspecified route of administration in left arm, on 19Jan2021 (Tuesday) at 13:45 (around 01:45 PM), at a single dose, for COVID-19 immunization. The patient's medical history included thyroid. The patient's concomitant medication included unspecified thyroid medication. The patient previously took the first dose of BNT162B2 (Lot Number: EH9899) on 29Dec2020 (in left arm) for COVID-19 immunization. The patient had no other recent vaccinations. The patient's work scheduled the vaccine for them through a third-party provider. The patient received her second dose of the vaccine on Tuesday and has a fever on Wednesday (20Jan2021) afternoon (about 12:00 PM) which continues to spike. For treatment, the patient took two of ibuprofen 200 mg, and didn't exceed 6 in a day; she took it every 8 hours or so by mouth. The patient didn't know if there were signs to be looking for. The patient's temperature from this this morning (21Jan2021) was 101 degrees Fahrenheit, which dropped to 99.6 degrees Fahrenheit, and is now 101.7 degrees Fahrenheit. The patient would like to know when she should be concerned and if there was a specific temperature to reach after which Pfizer advises to seek help. The patient had not recovered from the event. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1004373
Sex: F
Age:
State: WI

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
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Symptoms: Headache; body aches; joint pain; chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el0142), via an unspecified route of administration on left arm on 20Jan2021 at single dose for Covid-19 immunization. The patient medical history was not reported. Concomitant medication included solifenacin succinate (VESICARE), dl-alpha tocopheryl acetate (VITAMIN E), omeprazole and Multivitamin. The patient previously received her firs dose of BNT162B2 at 11:00 AM on 02Jan2021 intramuscularly on left arm for Covid-19 immunization. The patient experienced headache, body aches, joint pain, chills and fatigue on 21Jan2021 05:00 AM. The events were reported as non-serious. The patient did not receive any treatment from events. The outcome of events was not recovered.

Other Meds: VESICARE; VITAMIN E [DL-ALPHA TOCOPHERYL ACETATE]; OMEPRAZOLE

Current Illness:

ID: 1004374
Sex: F
Age:
State: WA

Vax Date: 01/14/2021
Onset Date: 01/19/2021
Rec V Date: 02/05/2021
Hospital:

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Symptoms: getting jittery; tense; antsy; keyed up; blood pressure: 154/85; This is a spontaneous report from a contactable pharmacist, reporting for herself. A 47-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via an unspecified route of administration on 14Jan2021 at 16:30 (at the age of 47 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included Stage IV endometriosis, AVNRT/SVT cardiac arrhythmia, survivor of clear cell renal cell carcinoma (treated 2010), allergies: Lupron (rash), environmental allergies (grasses, trees, weeds, molds, animal dander), all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Drospirenone, ethinyl estradiol, betadex clathrate (YAZ), levonorgestrel (MIRENA), cetirizine hydrochloride (ZYRTEC), metoprolol succinate (TOPROL XL), and unspecified multivitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021 at 21:30, the patient starting getting jittery, tense, antsy, "keyed up". She took her blood pressure and it was 154/85. One hour later it was 148/89. Two hours later it was 158/88. The next day, on 20Jan2021 (day 6 post-vaccine), the blood pressure reading in the morning upon arising was 154/86. At 5 pm, it was 166/91. She doubled up on metoprolol succinate (TOPROL XL) dose, which didn't seem to alter the blood pressure at all, based on the home monitor readings. On day 7 post-vaccine (21Jan2021) it is as if the preceding day with the elevated blood pressure never happened; she felt perfectly fine and normal. Day 7 post vaccine, blood pressure resumed normal levels (115-120/70-80). The patient did not receive treatment for the events. The clinical outcome of getting jittery, tense, antsy, "keyed up", and blood pressure: 154/85 was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds: YAZ; MIRENA; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TOPROL XL

Current Illness:

ID: 1004375
Sex: F
Age:
State: NM

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 02/05/2021
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Symptoms: feeling some increasing shortness of breath; feeling some increasing shortness of breath; scratchy throat; some swelling in her bilateral periorbital area; have a mild headache; This is a spontaneous report from a contactable Pharmacist. A 38-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, lot # EL3302) intramuscular at single dose at right arm on 14Jan2021 11:30 for Covid-19 immunisation, administered at hospital. Medical history included, chronic headaches and vertigo, depression, type 2 diabetes mellitus (DMT2), hypertension, vitamin d deficiency, sleep apnoea syndrome (OSA), chronic pain, psoriatic arthropathy, allergies: ACE inhibtors, gabapentin, lisinopril, Lyrica, milk products, nuts. Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included: amlodipine (manufacturer unknown) 2.5mg, apremilast (manufacturer unknown), bupropion (manufacturer unknown) 150mg bid, calcipotriene (manufacturer unknown) topical, carvedilol (manufacturer unknown) 12.5mg bid, ergocalciferol (VIT D, manufacturer unknown) 1000 units, duloxetine (manufacturer unknown) 20mg bid, dicyclomine (manufacturer unknown) 20mg qid, losartan (manufacturer unknown) 50mg qday. The patient previously received the 1st dose of bnt162b2 (BNT162B2, lot # EL1284) intramuscular at single dose at left arm on 23Dec2020 12:30 PM for Covid-19 immunisation, administered at hospital. Patient denied any allergic reaction to the initial dose of Covid vaccine. No other vaccine has been received in 4 weeks. On 14Jan2021 12:00 PM after vaccination, she has being monitored for the mandatory 15-30 minute period, when she started feeling some increasing shortness of breath, scratchy throat, some swelling in her bilateral periorbital area. She was then taken to the ED for further evaluation. Patient denied any allergic reaction to the initial Covid vaccine 3 weeks before. She denied any abdominal pain, diarrhea, nausea, vomiting, chest pain, shortness of breath. She had a mild headache. In ED, patient received treatment with diphenhydramine 25mg IV, epinephrine 0.3mg IM, famotidine 20mg IV and dexamethasone 10mg IV, and LR 1,000mL bolus @ 1228, ketorolac 15mg @1312, ondansetron 4mg @1312. Patient monitored and discharged at 1530. Post vaccination, the patient has been tested with nasal swab for COVID-19 and resulted negative on 15Jan2021. Therapeutic measures were taken as a result of events. The outcome of recovered in Jan2021.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association

Other Meds: AMLODIPINE; APREMILAST; BUPROPION; CALCIPOTRIENE; CARVEDILOL; VIT D; DULOXETINE; DICYCLOMINE; LOSARTAN

Current Illness:

ID: 1004376
Sex: F
Age:
State: FL

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/05/2021
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Symptoms: Elevated heart rate that is almost like in her throat; Low grade fever; weakness that comes and goes/Very weak; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EH9899), via an unspecified route of administration on 20Jan2021 at a single dose for covid-19 immunization. The patient has no medical history and concomitant medications. On 20Jan2021, the patient experienced weakness that comes and goes/very weak. The patient reported that it started an hour and a half after the COVID-19 Vaccine. Comes in waves. At the time of the report, the patient stated that it was starting to subside, but after a while it will come back again. The patient added that she trying to fight through the weakness, but it was stopping her from doing things. The patient also experienced low grade fever on 20Jan2021 that was fluctuating. In the evening of 21Jan2021, the patient experienced elevated heart rate that was almost like in her throat. Heart rate was normally between 75-80, but it continues to jump over 100. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1004377
Sex: M
Age:
State: NC

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/05/2021
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Symptoms: fever; Headache; Chills; First dose: it was 3 weeks ago from 20Jan2021/ her son thinks it was 05Jan2021; pain under the arm; This is a spontaneous report from a contactable consumer (patient's mother). A 23-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 20Jan2021 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient previously received first dose of BNT162B2 (3 weeks ago, thinks it was 05Jan2021) for COVID-19 immunization. The reporter stated that her son worked in a doctor's office and got the second COVID 19 vaccine on 20Jan2021. Her son has a fever (started about 4PM) and she wanted to know if her son was contagious because he has a fever. He was experiencing quite a few side effects: headache and fever on 21Jan2021; and on 20Jan2021 chills and he started last night with pain under the arm. Outcome of the events pain under the arm and headache was not recovered, fever and chills were recovering. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1004378
Sex: M
Age:
State:

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/05/2021
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Symptoms: some lightheadedness for 1-2 hours after administration; some elevated heartrate in first 15 minutes after administration; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration at left arm on 20Jan2021 13:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin and experienced allergies. On 20Jan2021, the patient experienced some lightheadedness for 1-2 hours after administration and some elevated heartrate in first 15 minutes after administration. There was 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 recovered in Jan2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1004379
Sex: F
Age:
State: MI

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
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Symptoms: feeling dizzy/dizziness; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program, Pfizer First Connect. An 88-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at 09:45 at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. This evening or later this afternoon of 21Jan2021, the patient started feeling dizzy. She took something for the dizziness and then went to sleep. The reporter wanted to ask if that be something they need to worry about. They were wondering if this could come from the shot since it came on later. Outcome of the event was unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1004380
Sex: F
Age:
State: GA

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
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Symptoms: it looks and sounds like she has Bell palsy; mental fog; Nauseated; left side of face numb; left tongue felt numb and fat as though I got injected at the dentist; Then medicine taste in my mouth and some slurring; Then medicine taste in my mouth and some slurring; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old female patient received first dose of BNT162B2 (Lot number and expiry date not available), via an unspecified route of administration on 21Jan2021 10:45 at single dose in the left arm for COVID-19 immunization. Medical history included Hypo thyroid (medication not needed at this time). The patient had no known allergies. Concomitant medication included cefixime (FLEXERIL) and ibuprofen (IBU). On 21Jan2021 11:00, after 15 minutes of getting the vaccine, the patient felt nauseated. Then it continued to get worse from there left side of face numb, mental fog, left tongue felt numb and fat as though she got injected at the dentist. Then medicine taste in her mouth and some slurring. Stated that her boss which is doctor side it looks and sounds like she has Bell palsy. She was prescribed Methylprednisolone and she feel somewhat better. Still waiting to feel completely myself. It's been now about 8 hours since her vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all the events which included methylprednisolone. The outcome of the events was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 to the onset of reported events Bell palsy and mental fog occurred 15 minutes after getting the vaccine cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: FLEXERIL [CEFIXIME]; IBU

Current Illness:

ID: 1004381
Sex: F
Age:
State: NJ

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
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Symptoms: Swollen arm; sore arm; tiredness and some fatigue feeling in my upper back; tiredness and some fatigue feeling in my upper back; This is a spontaneous report from a contactable consumer reported for self. This 36-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL9262) at single dose in right arm on 20Jan2021 at 03:15 PM for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient experienced swollen arm, sore arm, tiredness and some fatigue feeling in her upper back on 21Jan2021. There was no treatment received for the adverse events. Serious was no: not results in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating and not congenital anomaly/birth defect. The outcome of events was resolving.

Other Meds:

Current Illness:

ID: 1004382
Sex: F
Age:
State:

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/05/2021
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Symptoms: itchiness; Injection site reaction of firmness beneath skin; Injection site reaction of swelling; Injection site reaction of redness; Injection site reaction of warmth; Injection site reaction of soreness; This is a spontaneous report from a non-contactable pharmacist (the patient). A 26-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3247), via an unknown route of administration in the left arm on 19Jan2021 at 16:30 (at the age of 26-years-old) as a single dose for Covid-19 immunization. Medical history included skin of upper arm is affected by mild eczema/atopic dermatitis, keratosis pilaris, hypertrophic scarring all from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was allergic to latex which causes a rash/ swelling. The patient's concomitant medications were not reported (did have other medications in two weeks, unspecified). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 20Jan2021 reported as for first day, the patient experienced Injection site reaction of firmness beneath skin, swelling, redness, warmth, soreness and on the second day also experienced itchiness. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site induration, vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pain was not recovered; pruritus was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1004383
Sex: M
Age:
State: IN

Vax Date: 12/29/2020
Onset Date: 01/18/2021
Rec V Date: 02/05/2021
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Symptoms: Sore throat; post-nasal drainage/rhinorrhea; post-nasal drainage/rhinorrhea; This is a spontaneous report from a contactable healthcare professional. This 46- year-old male patient received the first dose of BNT162B2 on 29Dec2020 6:30 PM (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EL1284), via intramuscular route of administration, (at the age of 46-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a Hospital and anatomically located on the left arm. Allergies to medications, food, or other products: Lactose intolerance. The medical history included: Heart/Double Lung Tx, Bronchiolitis obliterans. Concomitant medications included: Tacrolimus, Sirolimus, Enalapril, Prednisone, Bactrim, Zithromax, Prenatal vit, Citrical +D. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 18Jan2021, he experienced Sore throat, post-nasal drainage, and rhinorrhea. The patient did not receive treatment for the events. The clinical outcome of the events Sore throat, post-nasal drainage, and rhinorrhea was not recovered without treatment. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient received second dose BNT162B2 on 19Jan2021 at 06:30 pm (lot number: EL8982),Intramuscular, anatomically located on the left arm. No follow-up attempts are possible. No further information is expected.

Other Meds: TACROLIMUS; SIROLIMUS; ENALAPRIL; PREDNISONE; BACTRIM; ZITHROMAX; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; CITRICAL D

Current Illness:

ID: 1004384
Sex: F
Age:
State: KY

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/05/2021
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Symptoms: Had covid after 19 days got the vaccine; Had covid after 19 days got the vaccine; immediately lightheaded dizzy; body aches; severe sore throat; gums swollen and red; gums swollen and red; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 15Jan2021 15:15 at single dose for COVID-19 immunisation. Medical history included covid-19 (covid prior vaccination: Yes). No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID). No other vaccine in four weeks. The patient experienced side effects immediately lightheaded dizzy , body aches, severe sore throat, gums swollen and red on 15Jan2021, had covid after 19 days (as reported) got the vaccine. The events resulted in emergency room/department or urgent care. Events treatment included steroids and fluids. The outcome of events was not recovered. No covid tested post vaccination. The patient was not pregnant. Information about Lot/Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported covid based on the known safety profile. 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: SYNTHROID

Current Illness:

ID: 1004385
Sex: F
Age:
State:

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/05/2021
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Symptoms: Sore arm; headache; This is a spontaneous report from a non-contactable consumer. A 50-year-old female patient received received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular at single dose into the left arm on 20Jan2021 for COVID-19 immunization. Medical history and concomitant drugs were unknown. On 20Jan2021 the patient experienced sore arm and headache. No treatment for the events was received. At the time of reporting the patient was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Other Meds:

Current Illness:

ID: 1004386
Sex: M
Age:
State: NM

Vax Date: 12/01/2020
Onset Date: 01/07/2021
Rec V Date: 02/05/2021
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Symptoms: Acute hemolytic anemia; Felt pale and tachycardic; Felt pale and tachycardic; This is a spontaneous report from a contactable pharmacist. A 37-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), intramuscularly on 06Jan2021 12:30 on Left arm at single dose for COVID-19 immunization, facility where the most recent COVID-19 vaccine was administered in Hospital; pembrolizumab (KEYTRUDA), via unspecified route of administration from 01Dec2020 and from 22Dec2020 at unspecified dosage for unspecified indication. Medical history included thymic carcinoma stage IV, Allergy to adhesive tape. Concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (lot number=EJ1685) intramuscularly on 18Dec2020 14:15 on Left arm for COVID-19 immunization. It was reported that patient was receiving Keytruda (01Dec2020 and 22Dec2020) which could cause hemolytic anemia. Labs were stable on 22Dec2020. Patient felt pale and tachycardic the next day (07Jan2021) but didn't notify us. He had follow-up on 1/12/2021 at the cancer center. The labs were consistent with acute hemolytic anemia (12Jan2021 at 08:00 AM), and patient was closely followed by hematology. He was on immunotherapy for cancer treatment, but there was concern for COVID vaccine contributing the hemolytic anemia. Events were result in doctor or other healthcare professional office/clinic visit. Treatment received for acute hemolytic anemia included blood transfusion. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The action taken for pembrolizumab was unknown. The outcome of the events were not resolved.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events acute hemolytic anemia, pallor and tachycardia cannot be completely excluded. concomitant use of KEYTRUDA and patient's underlying medical condition may have also contributed to reported events. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: KEYTRUDA

Current Illness:

ID: 1004387
Sex: F
Age:
State: LA

Vax Date: 01/13/2021
Onset Date: 01/17/2021
Rec V Date: 02/05/2021
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Symptoms: I was sneezing non stop; injection site was sore; can't taste; nose started running/ my nose was like a faucet, non stop, clear; asked if it can it give her COVID since her symptoms were similar to COVID; asked if it can it give her COVID since her symptoms were similar to COVID; I felt scratchy in my throat; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248 and expiration date not provided), via an unspecified route of administration in the left arm on 13Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took shingles vaccine for immunization and experienced shingles. The patient reported that she got her first dose of the COVID vaccine on 13Jan2021. On 17Jan2021 night and into 18Jan2021, she felt scratchy in her throat. She did not think anything of it because the temperature change was not unusual in the patient's state and so she thought it was that. But, on 19Jan2021, her throat was more scratchy and then her nose started running more. By Wednesday, 20Jan2021, her nose was like a faucet, non stop, clear and her throat was definitely scratchy and she was sneezing non stop. Her injection site was sore too which she totally expected. Now, her physician has given her a steroid pack and did a rapid test, which was negative but the following day they are doing a PCR test, so, she will see. She also stated that she can still smell but can't taste and that started last night, 20Jan2021. She asked if they were seeing these. And if this was listed or being reported and if she should get the second dose. She went on to state that "I would not call my symptoms severe and I'm having my PCR tomorrow, but when they mention to me that they have had other patients with this experience". She also asked if it can it give her COVID since her symptoms were similar to COVID and other people are having symptoms. She also reported that 4 months ago, she got her first shingles vaccination and "it knocked me on my butt, I still haven't got the second injection but I got shingles" and asked should she have gotten the COVID vaccine if she just got over shingles 3-4 weeks ago. She reported that she got her first dose of the COVID vaccine on 13Jan2021 and her second dose is scheduled for 30Jan2021 (17days apart). She did not have a question about the timing of the vaccine, only mentioned when her second dose was due and the it was 17 days after the first. She wanted to know if Pfizer was seeing a lot of this, and it could this her body reacting to the vaccine. She wanted to know what she should do with the second vaccine, if she should get it. She works at a school and has been making sure to wash her hands and everything. The outcome of the events Rhinorrhoea, and Vaccination site pain was unknown. The outcome of the event ageusia was not recovered while the outcome of the rest of the events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082498 same drug/event, different patients

Other Meds:

Current Illness:

ID: 1004388
Sex: F
Age:
State: CA

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 02/05/2021
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Symptoms: body aches; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; solution for injection; lot number: EJ1685; expiration date: unknown), intramuscular left arm on 30Dec2020 08:00 AM at a single dose for covid-19 immunization. Medical history included crohn's disease, asthma and has known allergies. The patient was not diagnosed with COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but had received other medications within 2 weeks of vaccination. The patient reported that approximately 12 hours (30Dec2020 08:00 PM) later after the first injection, she had some body aches. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1004389
Sex: F
Age:
State: CT

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
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Symptoms: sore arm; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3247) on left arm on 21Jan2021 10:00 AM at a single dose for COVID-19 immunization. Medical history included Penicillin allergy. Patient was not pregnant. Concomitant medications were not reported. No other vaccine administered in four weeks. No other medications administered in two weeks. Patient experienced sore arm on 21Jan2021 10:30 AM with outcome not recovered. No treatment was received. No COVID prior vaccination. No COVID tested post vaccination.

Other Meds:

Current Illness:

ID: 1004390
Sex: F
Age:
State: CA

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/05/2021
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Symptoms: She had a tiny bit of soreness if she touched the vaccine injection site, but did not experience any soreness if she moved or lifted her arm; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 16Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she had her first dose of the Pfizer COVID-19 Vaccine on Saturday, 16Jan2021, with no side effects. The patient stated that she had read in the past that taking 1 ibuprofen before and after the flu vaccine was recommended. She said she also had medical people tell her the same. She recently read a study where it is recommended a person shouldn't take ibuprofen before or after receiving the COVID-19 Vaccine because the ibuprofen might interfere with the vaccine's effectiveness. She said she is now in a bit of a quandary moving forward, as to if she should take any kind of analgesic, or Ibuprofen, or anything of that nature before getting her second COVID-19 Vaccine dose. She took 1 Advil prior to receiving her first dose of the COVID-19 Vaccine. She wanted to know if she should not take any ibuprofen before her second COVID-19 Vaccine dose. The patient reported further that on 16Jan2021, she had a tiny bit of soreness in her arm, only if she touched the COVID-19 Vaccine injection site. She does not experience any soreness if she moved or lift her arm. Outcome of the event was unknown. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1004391
Sex: F
Age:
State: TN

Vax Date: 01/18/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
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Symptoms: face started itching; throat was getting dry; face was starting too itch and be red; hives after second dose of vaccine; This is a spontaneous report from a contactable Other HCP reported for herself. This 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EL1283, Expiry Date: 30Apr2021), via an unspecified route of administration on 18Jan2021 06:45 at single dose injected into left arm for COVID-19 immunisation. Medical history included asthma from 2010. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT EJ1685, EXP 31Mar2021.) on 18Jan2021 at 04:00PM, injected into her right arm for COVID-19 immunisation, uses salbutamol (ALBUTEROL, NDC: 6699301968, LOT: VE7L, EXP: Nov2021) inhaler as needed for asthma and took inhaled steroids, but nothing recent. The patient got the second dose of the vaccine at 06:45AM, and the hives began on the 21Jan2021, she noticed them about 06:20AM and she had to be at work at 07:00AM. She said she treated that with diphenhydramine hydrochloride (BENADRYL, 25mg LOT: P120108. EXP May2022, UPC: 193968051518) because her face started itching and her throat was getting dry, so she took BENADRYL 25mg this morning about 06:40AM. She says she took one dose of this by mouth, because it seems to make her sleepy and she had to work. She says she got to work and started working, and her face was starting too itch and be red, and her throat was super dry, this was at 07:20AM, so she took prednisone (NDC: 20603-5338-31, LOT 8675217, EXP Dec2020) 60mg by mouth. She says this was expired, but she still took it, it is in a dose pack that has a box that says distributed by (Company name). She says she took Prednisone 60mg, one time today by mouth. She says she has asthma so she keeps a prescription of Prednisone at home that her doctor writes so she can have it, she says with asthma she keeps Prednisone around. She says she also applied equate Hydrocortisone cream 1% (LOT: 0JT0306, EXP Aug2022) that she got over the counter to the hives topically. She says that the label for that says underneath anti-itch it says intensive healing that it is mixed with vitamins, chamomile and Vitamins A, C, and E. Equate Hydrocortisone cream 1% UPC: Unknown, the tube has a barcode with no number, it did have a box that she did throw away. She thought hives was medically significant, but it is not getting worse, it is worrisome, but she is improving with the medicine she used for treatment. The outcome of hives was recovering. The outcome of other events was unknown.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1004392
Sex: F
Age:
State: PA

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
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Symptoms: Tiredness and exhaustion after the vaccination; This is a spontaneous report received from a contactable consumer. A 37-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date: unknown), via an unspecified route of administration, on 21Jan2021, at single dose, for COVID-19 immunization, at the hospital. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 21Jan2021, the patient experienced tiredness and exhaustion after the vaccination. No treatment for the event was given. The outcome of the event was not recovered. The event was assessed as non-serious.

Other Meds:

Current Illness:

ID: 1004393
Sex: F
Age:
State: CA

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
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Symptoms: Higher than normal blood pressure; This is a spontaneous report from a contactable consumer, the patient. This 89 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 , single dose via an unspecified route of administration in the right arm on 21Jan2021 at 12:00 PM (at the age of 89 years-old) for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history was unknown. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 21Jan2021, the patient experienced higher than normal blood pressure. The event, higher than normal blood pressure was reported as non-serious. There was no treatment received for the event. The clinical outcome of higher than normal blood pressure was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

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Current Illness:

ID: 1004394
Sex: F
Age:
State: MO

Vax Date:
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Rec V Date: 02/05/2021
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Symptoms: Left axillary lymphadenopathy; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EJ1686/expiration date: not provided), via intramuscular route of administration, on an unknown date as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient previously received the first dose of BNT162B2 (lot number EH9899) on an unknown date for COVID-19 immunization. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Jan2021, the patient experienced left axillary lymphadenopathy. The patient did not receive any treatment for the event. The event left axillary lymphadenopathy was assessed as non-serious. The outcome of the event left axillary lymphadenopathy was not recovered. Since the vaccination, the patient had not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 1004395
Sex: F
Age:
State: MI

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/05/2021
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Symptoms: severe arm pain; Fever; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3249) via an unspecified route of administration in left arm on 20Jan2021 09:45 at single dose for Covid-19 immunization. Medical history included high blood pressure; thyroid disease; high cholesterol; prior stroke; prior to vaccination, the patient was diagnosed with COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced severe arm pain and fever on 20Jan2021 14:30. No treatment received for the adverse events. This is a non-serious report. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jan2021.

Other Meds:

Current Illness:

ID: 1004396
Sex: F
Age:
State: FL

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/05/2021
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Symptoms: felt "winded"/Increasing shortness of breath; nauseous; This is a spontaneous report from a contactable nurse (patient). This 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3248) via an unspecified route of administration in the left arm on 19Jan2021 at 12:30 at the age of 54-year-old at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included hypertension and obesity. Concomitant medication included vitamin C. The patient had a past drug history of allergy with hydromorphone hydrochloride (DILAUDID); she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231) on 29Dec2020 at 08:30 in the left arm and she experienced nausea and palpitations. On 20Jan2021 at 19:00, the patient felt "winded" and nauseous with increasing shortness of breath, particularly with having to apply mask. The patient did not receive corrective treatments. The patient did not have COVID-19 prior to vaccination, and she had not been tested for COVID-19 post vaccination. She was recovering from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021057652 Same patient, same drug, different dose/event

Other Meds: VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1004397
Sex: F
Age:
State: CO

Vax Date: 01/19/2021
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Symptoms: experiencing some mid-axillary pain radiating to my breast on the injection site arm; Low grade fever; This is a spontaneous report from a contactable nurse. A 44-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EK4176) vaccine , via an unspecified route of administration on 19Jan2021 at 0.3 mL, single for covid-19 immunisation . Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing. Concomitant medication included omeprazole (OMEPRAZOLE). On 29Dec2020, the patient received the first dose of BNT162B2 vaccine without any problem. The patient experienced some mid-axillary pain radiating to the breast on the injection site arm and low grade fever on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: low grade on unknown date. The reported events were considered non serious. The patient received treatment with Tylenol. Follow up information has been requested.

Other Meds: OMEPRAZOLE

Current Illness:

ID: 1004398
Sex: F
Age:
State: LA

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/05/2021
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Symptoms: Injection site pain; Tiredness; Mild headache; Chills; Muscle pain; Severe joint pain; Injection site swelling; Feeling unwell; Swollen lymph nodes, specifically left underarm area; Shortness of breath; Fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 19Jan2021 16:45 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient medical history was not reported. No allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site pain, tiredness, mild headache, muscle pain, chills, severe joint pain, injection site swelling, feeling unwell, swollen lymph nodes, specifically left underarm area, shortness of breath and fast heartbeat on 20Jan2021 14:30. Not received treatment for the adverse events. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in Jan2021.

Other Meds:

Current Illness:

ID: 1004399
Sex: M
Age:
State: AZ

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 02/05/2021
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Symptoms: migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it; migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it; migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it; This is a spontaneous report from a contactable 57-year-old male other health care professional reported for himself. A 57-years-old male patient started to receive second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration at Left arm on 07Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included pinched nerve in left leg and kidney stones (recovered). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685) Intramuscular at Left arm on 17Dec2020 04:00 PM for covid-19 immunization. The patient experienced migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it. it had been going on since second dose and got worse, not sure if can continue work. The event started on 08Jan2021 02:00 AM, no treatment received for the adverse events. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No allergies to medications, food, or other products. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1004400
Sex: F
Age:
State: AR

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/05/2021
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Symptoms: red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine; red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine; red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine; red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine, spreading to entire trunk, including face, bilateral arms, chest, abdomen, and thighs; This is a spontaneous report from a contactable nurse, reporting for herself. A 28-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK9231, via an unspecified route of administration on 15Jan2021 at 11:00 (at the age of 28 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included crohn's disease from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Ustekinumab (STELARA), sertraline, imipramine, colestipol, and B12, all from an unknown date for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination, The vaccine was given at a Hospital. On 15Jan2021 at 13:30, the patient experienced red, bumpy, itchy, scaling rash around injection site within two hours of receiving vaccine, spreading to entire trunk, including face, bilateral arms, chest, abdomen, and thighs within 24 hours. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events which included Medrol dose pack. The clinical outcome of red, bumpy, itchy, scaling rash around injection site within two hours of receiving vaccine, spreading to entire trunk, including face, bilateral arms, chest, abdomen, and thighs within 24 hours was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds: STELARA; SERTRALINE; IMIPRAMINE; COLESTIPOL; B12

Current Illness:

ID: 1004401
Sex: F
Age:
State: ME

Vax Date: 01/09/2021
Onset Date: 01/11/2021
Rec V Date: 02/05/2021
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Symptoms: Tinnitus; headache; This is a spontaneous report from a contactable other Health Professional (patient). A 37-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration on 09Jan2021 10:00 at single dose in right arm for covid-19 immunization. Medical history included chronic pain, hypothyroidism and anxiety, allergies to medications, food, or other products included sulfa.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine, eszopiclone (LUNESTA), ibuprofen (MOTRIN), celecoxib (CELEXA). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. No treatment was received. The patient experienced tinnitus and headache on 11Jan2021. The outcome of the events was recovering.

Other Meds: LEVOTHYROXINE; LUNESTA; MOTRIN [IBUPROFEN]; CELEXA [CELECOXIB]

Current Illness:

ID: 1004402
Sex: M
Age:
State: TX

Vax Date: 01/16/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
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Symptoms: extreme chills; awful headache; body aches; severe sweating; low oxygen; 102 degree temperature; 120 pulse rate(abnormal for me); my arm felt like it was broken (9/10), but no other problems. Twelve hours later, the pain was still 9/10".; shoulder still sore; This is a spontaneous report from a contactable 58-year-old female consumer reporting for herself A 58 years old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249) on 16Jan2021 at 23:30 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. The patient did not have medical history. Concomitant medications were not reported. The patient reported at inoculation, the injection was high on right arm, and his arm felt like it was broken (9/10), but no other problems. On 17Jan2021 twelve hours later, the pain was still 9/10 so the patient put two heating pads on the site of injection. On the same day (17Jan2021) shortly thereafter, patient also experienced extreme chills, low oxygen (94), 102 degree temperature, 120 pulse rate (abnormal for him), awful headache, body aches, then severe sweating. This peaked 8 hours later and it was gone within 24 hours. No Treatment was given for the events. At the time of rh reporting the patient informed his shoulder was much better, but still sore. Patient also informed he was positive for SARS-Cov-2 from 07Dec2020 to 28Dec2020.He had mild symptoms. The patient recovered with sequel from the events on an unspecified date.

Other Meds:

Current Illness:

ID: 1004403
Sex: F
Age:
State: NC

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
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Symptoms: swelling of (most likely) lymph nodes in left armpit (same arm as vaccination); This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 20Jan2021 14:15 at SINGLE DOSE at Left arm for covid-19 immunisation . Medical history included basal cell carcinoma. Concomitant medication included l-arginine [arginine]. The patient experienced swelling of (most likely) lymph nodes in left armpit (same arm as vaccination) on 21Jan2021 17:00. No treatment for the event. The outcome of event was not recovered. Information on the lot/batch number has been requested.

Other Meds: L-ARGININE [ARGININE]

Current Illness:

ID: 1004404
Sex: F
Age:
State:

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
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Symptoms: a "little bit" of headache; This is a spontaneous report from a Pfizer Sponsored program, received from a non-contactable consumer reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) , via an unspecified route of administration on 21Jan2021 as a SINGLE DOSE for COVID-19 vaccination. The patient's medical history included migraines from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 21Jan2021, the patient experienced a "little bit" of headache, but it is nothing unusual to her since she has always had migraines in the past. She said apart from that, she is not experiencing any side effects as of the moment. If in case she experiences any more headaches, she wants to know if it would be okay to take ibuprofen (ADVIL), Ibuprofen or acetaminophen (TYLENOL) to treat it. The clinical outcome of a "little bit" of headache was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1004405
Sex: M
Age:
State: CA

Vax Date: 01/11/2021
Onset Date: 01/14/2021
Rec V Date: 02/05/2021
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Symptoms: dysaesthesia in the right arm (upper arm on the posterior aspect and forearm) and right hip/thigh; the right shoulder, right elbow, and right hip joints are mildly sore; pins and neeles sensation; This is a spontaneous report from a contactable consumer who is the patient. A 39-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686) intramuscularly in the right arm on 11Jan2021 at 8:30 (at the age of 39-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included hypertension and migraines. The patient does not have allergies to medication, food, or other products. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EK5730) in the right arm on 18Dec2020. Prior to vaccination, the patient had not been diagnosed with COVID-19. The patient was administered the vaccine in a Hospital. The patient's concomitant medications were not reported. Beginning on 14Jan2021 the patient started to experience dysaesthesia in the right arm (upper arm on the posterior aspect and forearm) and right hip/thigh. Discomfort feels like pins/needles sensation anytime skin is touched lightly (such as blankets, clothing etc). As of the reporting date, the symptoms persist. In addition, the right shoulder, right elbow, and right hip joints are mildly sore which also are persistent. No perceived muscle weakness and no associated numbness. Treatment was not received for the events. Lab data included two post vaccination COVID 19 tests. A PCR nasal swab test on 11Jan2021 and a PCR nasal swab test on 17Jan2021 both of which were negative for COVID-19. The clinical outcomes of dysaesthesia, joint soreness and pins and needles were reported as not recovered.

Other Meds:

Current Illness:

ID: 1004406
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 02/05/2021
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Symptoms: little nervous; little more scary for her as she is kind of scared of anaphylaxis, normal anxiety range; sensation of throat fullness and tingling with a strange itchy feeling; sensation of throat fullness and tingling with a strange itchy feeling; sensation of throat fullness and tingling with a strange itchy feeling; allergic reaction; This is a spontaneous report from a contactable psychiatrist reported for herself and another physician and consumer. This female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 30Dec2020 as a single dose for COVID-19 immunisation. Medical history included occupational exposure to COVID-19. The patient had been taking care of patients as a psychiatrist throughout this COVID-19 pandemic. Concomitant medications were not reported. The patient experienced a sensation of throat fullness and tingling with a strange itchy feeling about 10 minutes after the vaccine was given on 30Dec2020. The patient was monitored in the emergency room (ER) for six hours and did not need to give epinephrine (EPIPEN) or antihistamines and she was sent home. By the next morning, her throat was back to normal. The patient reported that she knew at least three other people who had the same reaction and had heard others too (AER 2021058666). The patient stated that she had read a bunch and there were differing theories on whether this is complement mediated, IgE or something else. The patient and her immunologist/allergist are trying to figure out how to go about next dose. Her immunologist/allergist wanted to do a skin test but it is impossible to get a sample of the second shot to do that. The patient and her immunologist/allergist were very reluctant for her to get it because of the uncertainty about the possibility of increased allergic reactions from the second shot. The patient is supposed to get next dose tomorrow 22Jan2021, but she is getting a little nervous about how much is unknown. At the same time, she is face-to-face with patients daily and does worry about her exposures. The patient wanted to get Pfizer opinion on all this if company think it would be worthwhile to "risk it" and just get the dose under observation with epinephrine around or if waiting for more information would be better. The patient stated that she was not an anxious person, but this one is a little more scary for her as she is kind of scared of anaphylaxis (which as a psychiatrist, she would put in normal anxiety range). Another reporter also mentioned the allergic reaction and asked if there is any possibility of getting a small sample of the second shot for skin testing and ask for advice on what the patient should do. The outcome of the events sensation of throat fullness and tingling with a strange itchy feeling and allergic reaction was resolved. The outcome of the other events was unknown. Information on the lot/batch number has been requested.

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Current Illness:

ID: 1004407
Sex: M
Age:
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Vax Date: 01/11/2021
Onset Date: 01/18/2021
Rec V Date: 02/05/2021
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Symptoms: One week after the second vaccine I developed Bell's Palsy; This is a spontaneous report from a contactable other health professional reported for himself. A 30-year-old male patient received second dose of bnt162b2, via an unspecified route of administration in left arm on 11Jan2021 11:00 at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included terbinafine, cetirizine hydrochloride (ZYRTEC), multivitamin. The patient previous received first dose of bnt162b2, via an unspecified route of administration in right arm on 21Dec2020 11:00 for covid-19 immunization. The patient experienced one week after the second vaccine, he developed bell's palsy on 18Jan2021 with outcome of not recovered. The event was reported as non-serious. The adverse event result in a visit to emergency room/department or urgent care. Treatment Prednisone, valacyclovir was received for the adverse event. Facility where the most recent COVID-19 vaccine was administered: School or Student Health Clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported event Bell's palsy. 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: TERBINAFINE; ZYRTEC

Current Illness:

ID: 1004408
Sex: F
Age:
State: HI

Vax Date: 01/20/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
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Symptoms: has a very stiff neck; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 (at the age of 82-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on an unspecified date (at an unspecified age). On an unspecified date in Jan2021, the patient had a very stiff neck. The reporter inquired if the patient can take over the counter pain medication for the very stiff neck. The clinical outcome of the very stiff neck was unknown. Information on the lot/batch number has been requested.

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Current Illness:

ID: 1004409
Sex: F
Age:
State: LA

Vax Date: 01/13/2021
Onset Date: 01/18/2021
Rec V Date: 02/05/2021
Hospital: Y

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Symptoms: She thinks she had a delayed anaphylactic shock she was definitely in shock; hypothermic; her adrenal glands are over compensating, working over load; she was having diarrhea; throwing up; she went from cold to profusely sweating back to having chills; she went from cold to profusely sweating back to having chills; she had no blood to her extremities; severe abdominal cramps; headache; her body is just weak; she was feeling dizzy; Her legs were cramping; her heart was racing fast; her lactic acid was really high; This is a spontaneous report from a contactable Nurse. A 53-years-old female patient receive the first dose of bnt162b2 (BNT162B2; Lot # EL3249) vaccine , via an unspecified route of administration in the right deltoid on 13Jan2021 15:55 at single dose for Covid-19 immunisation . Medical history included hypertonic bladder from an unknown date., drug hypersensitivity from an unknown date , migraine from an unknown date. She had migraines. Concomitant medication included solifenacin succinate (VESICARE), buspirone hydrochloride (BUSPAR), spironolactone (SPIRONOLACTONE). The patient previously took flu vaccine VII, bactrim and experienced drug hypersensitivity. The patient stated she thinks she had a delayed anaphylactic shock she was definitely in shock on an unknown date with outcome of unknown , hypothermic on an unspecified date with outcome of unknown , her adrenal glands are over compensating, working over load on an unspecified date with outcome of unknown , she was having diarrhea on an unspecified date with outcome of not recovered , throwing up on an unspecified date with outcome of unknown , she went from cold to profusely sweating back to having chills on an unspecified date with outcome of unknown , she had no blood to her extremities on an unspecified date with outcome of unknown , severe abdominal cramps on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of not recovered , her lactic acid was really high on 18Jan2021 with outcome of unknown , her body is just weak on an unspecified date with outcome of not recovered , her heart was racing fast on 18Jan2021 with outcome of unknown , she was feeling dizzy on 22Jan2021 with outcome of unknown , her legs were cramping on 19Jan2021 with outcome of unknown. The patient was hospitalized because of the events from 16Jan2021 to 17Jan2021. The patient underwent lab tests and procedures which included blood lactic acid: high on unknown date, chest x-ray: unknown results on unknown date, computerised tomogram: unknown results on 18Jan2021 , electrocardiogram: unknown results on unknown date. The patient was given fluids, Toradol and Xanax to treat the events. Further information has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be completely 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: VESICARE; BUSPAR; SPIRONOLACTONE

Current Illness:

ID: 1004410
Sex: F
Age:
State: MD

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/05/2021
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Symptoms: the arm was very sore all the way down to her elbow; Queasy; pasty frequent stool; pasty frequent stool; the outside of her arm where the vaccine was put hurt that day; This is a spontaneous report from a contactable consumer. A 81-year-old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1284), at single dose into the left arm on 16Jan2021 at 12:30PM for COVID-19 immunization. Concomitant drugs included Levothyroxine 0.100mg once daily by mouth taking for years for thyroid and a week and half before the vaccine administration, she had a cortisone shot in her hip for bursitis but it didn't work, it was the first time she has had one in a long time. The patient reported that on 16Jan2021 the outside of her arm where the vaccine was put hurt that day, but then the next day the arm was very sore all the way down to her elbow. But it was bad, she couldn't roll in bed form the pain. Then she woke up on 17Jan2021 queasy like morning sickness that didn't go away until 21Jan2021. Adds she also noticed that day she was having more frequent and pasty stools. Mentions she expected her arm to be sore because with the second shingles vaccine her arm was sore. States this was years ago and she did not have any product or information for the shingles vaccine. The patient is scheduled for the second dose on 06Feb2021. Mentions she lives in a continuous care facility and they will give her the shot. The event arm hurt recoverd on 20Jan2021, the other events resolved on 21Jan2021.

Other Meds: LEVOTHYROXINE; CORTISONE

Current Illness:

ID: 1004411
Sex: F
Age:
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Symptoms: right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides/ hurting; right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides/ hurting; This is a spontaneous report from a contactable consumer reporting for self. An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After the hurting started on an unspecified date, she had taken ibuprofen and tramadol. , Her right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides; she wanted to know if there is anything she could do to eliminate that or make it less consuming. She wanted to know if there was anything she could do to make the hurting less strenuous or if she can lay or walk a certain way to make it feel better. The end of the second phase of the vaccine is coming on 07Feb2021 and she needed to know if she should go ahead and take that. She hadn't been driving a car while this was going on because she was afraid of running into something. The event was reported as non-serious. The outcome of the event right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides/hurting was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

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Current Illness:

ID: 1004412
Sex: F
Age:
State: GA

Vax Date: 01/15/2021
Onset Date: 01/16/2021
Rec V Date: 02/05/2021
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Symptoms: Next day after the shot i feel a pain under my left arm. Days later the pain increase and i think is lymphoma; Next day after the shot i feel a pain under my left arm. Days later the pain increase and i think is lymphoma; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL1283, expiry: unknown), via an unspecified route of administration in the left arm on 15Jan2021 07:00 at a single dose for COVID-19 immunization. The patient has no medical history and no known allergies. The patient has no Covid prior to vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient mentioned that the next day after the shot (16Jan2021 at 05:30), the patient feel a pain under her left arm; days later, the pain increased, and she thinks it is lymphoma. The patient was not tested for Covid post vaccination. The outcome of the events was not recovered.

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Current Illness:

ID: 1004413
Sex: F
Age:
State: NY

Vax Date: 01/19/2021
Onset Date: 01/22/2021
Rec V Date: 02/05/2021
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Symptoms: have two discoloration in my right thumb one black long line and one red line side by side around 1 and a half inches long and behind it is a circular black and discoloration; This is a spontaneous report from a contactable other hcp. A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3247), via an unspecified route of administration on the right arm on 19Jan2021 12:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, supraventricular tachycardia and hearing loss from an unknown date and unknown if ongoing. Concomitant medication included amlodipine (AMLODIPINE) and metoprolol tartrate (METOPROLOL TARTRATE). On 22Jan2021 05:00 AM, the patient stated, "I have two discoloration in my right thumb one black long line and one red line side by side around 1 and a half inches long and behind it is a circular black and discoloration." No treatment was received for the events. The outcome of the event was not recovered.

Other Meds: AMLODIPINE; METOPROLOL TARTRATE

Current Illness:

ID: 1004414
Sex: M
Age:
State: NC

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/05/2021
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Symptoms: Minor soreness at injection site. Lasted about 48 hours; Minor sweats day of vaccination. Lasted 5 hours; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 19Jan2021 09:00 at SINGLE DOSE on Arm Left for covid-19 immunisation. The patient medical history was not reported. No covid prior vaccination. No other vaccine in four weeks. Known allergies: No. Had other medications in two weeks. The patient experienced minor soreness at injection site. lasted about 48 hours since on 19Jan2021 with outcome of recovered on 21Jan2021, minor sweats day of vaccination. lasted 5 hours on 19Jan2021 with outcome of recovered in Jan2021. No treatment received. No covid tested post vaccination.

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Current Illness:

ID: 1004415
Sex: M
Age:
State: NY

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
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Symptoms: soreness in his arm; This is a spontaneous report from a contactable consumer. An adult male patient received first single dose of BNT162B2 (Pfizer/BioNTech, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on Jan2021 for COVID-19 immunization. The patient had no relevant medical history. The patient did not have covid prior vaccination. The patient's concomitant medications were not reported. The patient reported after his first shot he had soreness in his arm (onset date: Jan2021). The patient was not covid tested post vaccination. The outcome of the event was unknown. Information on the lot/Batch number has been requested.

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Current Illness:

ID: 1004416
Sex: F
Age:
State: SC

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
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Symptoms: administration date= 04Jan2021/Other vaccine same date vaccine date=21Jan2021; Lightheaded/Dizzy; vomiting; This is a spontaneous report from a contactable other HCP. This 24-year-old female other HCP (no pregnant) received 2nd dose of BNT162B2 (lot number=EL3249) on 21Jan2021 at single dose on Left Arm for covid-19 immunization. Medical history was Total colonic Hirschsprung's disease, POTS, asthma, chronic migraines, recurrent pneumonia, GERD. Historical Vaccine was 1st dose of BNT162B2 (Lot number= EL1284 on 04Jan2021 09:30 AM on Left arm). Known allergies: Erythromycin, azithromycin (Z-PACK), metoclopramide (REGLAND), diphenhydramine hydrochloride (BENADRYL). Concomitant drug included topiramate (TOPAMAX), esomeprazole sodium (NEXIUM), famotidine (PEPCID), ondansetron (ZOFRAN), budesonide/formoterol fumarate (SYMBICORT). No other vaccine in four weeks. Patient experienced Lightheaded, dizzy, vomiting on 21Jan2021 11:15 PM with outcome was recovered. No treatment. No Covid prior vaccination. No covid tested post vaccination. No follow-up attempts possible. No further information expected.

Other Meds: TOPAMAX; NEXIUM; PEPCID; ZOFRAN; SYMBICORT

Current Illness:

ID: 1004417
Sex: M
Age:
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Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
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Symptoms: severe diarrhea; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter was to report a possible side effect. The patient experienced severe diarrhea in Jan2021. Outcome of the event was unknown. Information on the lot/batch number has been requested.

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ID: 1004418
Sex: F
Age:
State: NJ

Vax Date: 01/20/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
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Symptoms: chills; muscle ache; joint pain; sweat; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received second single dose of BNT162B2 (Solution for injection, lot number: EL3247, exp date not reported), via an unspecified route of administration (Anatomical location: Arm Right)on 20Jan2021 15:00 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. The patient previously took first single dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunization. The patient experienced chills, muscle ache, joint pain, and sweat on Jan2021. The events were considered as non-serious. The outcome of events was unknown.

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ID: 1004419
Sex: F
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State: TX

Vax Date: 01/02/2021
Onset Date: 01/08/2021
Rec V Date: 02/05/2021
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Symptoms: developed COVID symptoms/diagnosed positive in Covid19/ tested positive for Covid; developed COVID symptoms/diagnosed positive in Covid19/ tested positive for Covid; This is a spontaneous report from a contactable nurse (patient). This nurse reported same event for two patients (patient and her husband), this is the first of two reports, the report for patient herself. A 69-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL0142, expiration date unknown), via an unspecified route of administration in arm (reported as deltoid) on 02Jan2021 at single dose for COVID-19 immunization. The patient denied relevant medical history. Concomitant medications were not reported. The patient got her first dose on 02Jan2021, and on 08Jan2021 developed COVID symptoms. On 11Jan2021, she tested positive for COVID-19/diagnosed positive in COVID-19. The reporter nurse think they were exposed sometime at that pharmacy, she mean there was a lot of people in the line. Tomorrow (unspecified) was supposed to be second dose and his family physician didn't know if he should get that second dose. The outcome of events was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021064940 Same reporter/drug/event, different patient

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Total 2021 VAERS Injuries: 704,237

Page last modified: 03 October 2021 5:28pm