VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
46,870MODERNA
532GLAXOSMITHKLINE BIOLOGICALS
353PFIZER\BIONTECH
231MERCK & CO. INC.
221UNKNOWN MANUFACTURER
62SEQIRUS, INC.
25DYNAVAX TECHNOLOGIES CORPORATION
13EMERGENT BIOSOLUTIONS
12SANOFI PASTEUR
9NOVARTIS VACCINES AND DIAGNOSTICS
5PFIZER\WYETH
5PAXVAX
2TEVA PHARMACEUTICALS
2PROTEIN SCIENCES CORPORATION
1BERNA BIOTECH, LTD.
1INTERCELL AG
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL1,906
1,575
289
IMM209286
252
236
229
s029456178
171
UT7065MA166
155
149
145
S034636133
107
U62828AA103
100
98
P10025327596
U6737AA85
UJ446AA79
78
78
59
57
4BH3254
4F47253
52
27656352
50
PP9L548
49TM346
42
40
38
MENVEO38
4F47237
R1B252M36
34
C5763AA30
93362229
25
300057A24
UNK24
22
CW311621
18
17
15
UH894AB15
3Y7NL12
R1B743M12
EJ168611
el128410
10
10
10
9
ARBA141A9
UNK9
8
UNK8
8
1F4EB8
Unknown7
7
No batch number6
5
5
UJ090AA5
5
5
4
4
4
UNK4
JEV18K95E4
UNK3
A115A3
Z127A3
3
3333324181073
2
2
2
TAR352
1
1
1
1
1
A739081
1
1
1
1
1
037K20A68,542
EL128447,700
133

Incidents per State

State Total
15,185
CA14,096
NY7,507
TX7,196
FL6,939
IN5,527
PA4,560
IL4,179
OH4,054
AZ3,856
MI3,771
NJ3,411
MA3,278
VA3,208
NC3,114
WA3,034
GA2,864
MD2,652
MN2,534
CO2,532
WI2,457
MO2,029
OR1,943
TN1,715
CT1,693
KY1,603
OK1,226
AL1,201
KS1,162
IA1,157
SC1,106
NM1,065
UT973
AR951
LA945
NE829
NV797
ME795
MT789
NH756
ID674
AK661
WV661
PR650
MS585
HI536
RI510
VT441
SD361
ND356
DE350
DC239
WY209
GU32
AS16
VI13
MP9
MH3
FM2
QM1
XB1

ID: 1070694
Sex: M
Age:
State: MA

Vax Date: 02/13/2021
Onset Date: 02/14/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Date: 20210214; Test Name: body temperature; Result Unstructured Data: Test Result:100.6 Fahrenheit; Comments: fever initially; Test Date: 20210214; Test Name: body temperature; Result Unstructured Data: Test Result:101.1 Fahrenheit; Comments: by about 5pm day after shot

Allergies:

Symptoms: chills; fever initially 100.6F/Fever returned at 101.1F by about 5pm; aches (injection site); aches (spine); aches (occiput); aches ( hips, knees); This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old male patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 13Feb2021 14:30 at single dose for COVID-19 immunisation . The patient medical history was not reported. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 in left arm on 23Jan2021 at 12:30 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Beginning approx 11 hours post (14Feb2021 01:00) was chills, aches (spine, occiput, hips, knees, injection site), and fever initially 100.6F. Fever reduced acetaminophen over time. Aches continued. Fever returned at 101.1F by about 5pm day after shot. The patient underwent lab tests and procedures which included body temperature: 100.6 fahrenheit (fever initially) on 14Feb2021, body temperature: 101.1 fahrenheit by about 5pm day after shot on 14Feb2021. Treatment received for the adverse event included acetaminophen, water, rest The outcome of events aches (spine, occiput, hips, knees, injection site) was not recovered, the outcome of other events was recovered on an unspecified date of Feb2021. This case was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1070695
Sex: F
Age:
State: MI

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: The site is still red, painful and hot to the touch; The site is still red, painful and hot to the touch; The site is still red, painful and hot to the touch; This is a spontaneous report from a contactable consumer (reported for herself). A 49-year-old female patient (not pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 13Feb2021 08:15 at single dose in left arm for COVID-19 immunisation. Medical history included diabetes type 2; no Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included sertraline; acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE). The patient previously took the first dose of bnt162b2 on 19Jan2021 07:15 (at the age of 39 years old) in left arm for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It has been over 72 hours since the vaccination. The site was still red, painful and hot to the touch which started from 13Feb2021 08:15. Not sure if this was normal for this to continue so long. No treatment received for the adverse events. The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds: SERTRALINE; EXCEDRIN MIGRAINE

Current Illness:

ID: 1070696
Sex: M
Age:
State: NJ

Vax Date: 02/14/2021
Onset Date: 02/15/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Date: 20210215; Test Name: body temperature; Result Unstructured Data: Test Result:101.3; Comments: fever; Test Date: 20210215; Test Name: pulse; Result Unstructured Data: Test Result:121-133; Comments: Rapid pulse

Allergies:

Symptoms: Rapid pulse 121-133; fever 101.3; chills; dizzy; body aches; This is a spontaneous report from a contactable consumer (parent). A 17-years-old male patient received bnt162b2 (BNT162B2, lot number=EM9709) second dose, vaccination location of left arm, via an unspecified route of administration on 14Feb2021 17:15 at SINGLE DOSE for covid-19 immunisation. Medical history was none. No Allergies to medications, food, or other products. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 24Jan2021 16:00 (lot number=EL9261; vaccine location=Left arm). The patient experienced rapid pulse 121-133, fever 101.3, chills, dizzy and body aches, all on 15Feb2021 14:30 with outcome of recovering. No treatment received for events. The patient underwent lab tests which included body temperature: 101.3 on 15Feb2021, heart rate: 121-133 on 15Feb2021. The events reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 1070698
Sex: U
Age:
State:

Vax Date: 01/27/2021
Onset Date: 02/10/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Bells Palsy; This is a spontaneous report from Pfizer-sponsored program. A contactable healthcare professional reported that a patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, first dose on 27Jan2021 at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient received first COVID vaccine 27Jan2021 and was diagnosed with Bells Palsy on 10Feb2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.; 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 Bell's palsy 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:

Current Illness:

ID: 1070699
Sex: F
Age:
State: NJ

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

Lab Data:

Allergies:

Symptoms: Angioedema; swelling; Difficulty breathing; Tight chest; Facial flushing; Dry eyes and unsettled stomach; Dry eyes and unsettled stomach; This is a spontaneous report from a contactable nurse. A 27-years-old non-pregnant female patient started treceive bnt162b2 (BNT162B2), Lot number: EL9266, intramuscular in left arm on 15Feb2021 at 0900 (at the age of 27 years-old) for COVID-19 immunzation. The vaccination was administered at a workplace clinic. Medical history included Allergy/Sports-Induced Asthma, Lactose Intolerant and food allergies of Kiwi, Lactose Intolerant, Cherry. The patient had a positive COVID-19 test prior to vaccination on 14Nov2020. There was no other vaccinations given within 4 week and concomitant medications within 2 weeks included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), fish oil (FISH OIL). On 15Feb2021 at 10:00, the patient experienced Angioedema/swelling, Difficulty breathing/tight chest, facial flushing, dry eyes and unsettled stomach. Experienced symptoms of flushing 1hour post-vaccination. The clinical course was as follows: She reported that she experienced symptoms of flushing 1hour post-vaccination. About 4 hours later swelling persisted and took Zyrtec to alleviate symptoms, which provided minimal relief. 24 hours post vaccination resulted in ER admission advised per Occupational Medicine at (name). IV SoluMedrol, Bendaryl and Pepcid administered. Overall stay in ER 3 hours. On 17Feb2021, 24 hours post admission rebound symptoms occurring with facial flushing and swelling. Will repeat allergy medication to relieve symptoms PRN. The clinical outcome of the events was recovered with sequalae (as reported by patient: recovered with lasting effects).

Other Meds: LO LOESTRIN FE; ZYRTEC-D; VITAMIN C [ASCORBIC ACID]; FISH OIL

Current Illness:

ID: 1070700
Sex: F
Age:
State: GA

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Date: 20210203; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normally; dizzy; nauseous; flu like symptoms; shooting sensations down both arms; memory issues; joint pain; headaches; varying rashes; trouble speaking, thinking, and understanding; trouble speaking, thinking, and understanding; This is a spontaneous report from a contactable nurse (the patient). A non-pregnant 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 11Jan20210 at 07:30 AM (at the age of 33-years) as a single dose for COVID-19 immunization. Medical history included migraines. The patient had known allergies to Sulfa, and codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on unspecified date for COVID-19 immunization. On 11Jan2021 at 10:15 AM, the patient experience vertigo (reported as caused disability); fluid in ears and lungs, muscle weakness, inability to walk normally, dizzy, nauseous, flu like symptoms for two weeks, shooting sensations down both arms, , memory issues, trouble speaking, thinking, and understanding, joint pain, headaches, varying rashes that she have never experienced on my body in various areas. The patient visited the physician office and had an emergency room visit due to the events. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and it was negative on 03Feb2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vertigo and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1070701
Sex: F
Age:
State: NY

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 03/03/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: couldn't walk; could not move her legs, her waist, and her hips; This is a spontaneous report from a contactable consumer, the patient. This 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 2 , single dose via an unspecified route of administration for COVID-19 vaccination on 14Jan2021. Medical history and concomitant medication were not reported. On 15Jan2021, the patient couldn't walk and could not move her legs, her waist, and her hips. This has never happened before. It has been a month since the incident happened and it has not been resolved. She has been in the hospital for 6 days now receiving physical therapy and is waiting for a follow up appointment from her doctor. She is using a walker to assist her in walking. The clinical outcomes of events couldn't walk and could not move her legs, her waist, and her hips is not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1070702
Sex: M
Age:
State: MO

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

Lab Data: Test Date: 20210217; Test Name: tongue temperature reading; Result Unstructured Data: Test Result:97.9

Allergies:

Symptoms: felt a little colder than usual; trouble falling asleep; general feeling of malaise; pressure building in my head and abdomen; pressure building in my head and abdomen; left shoulder became increasing sore over 24 hours; This is a spontaneous report from a contactable consumer reported for himself that: 43-years-old male patient started to receive the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 16Feb2021 15:45 at single dose at left arm for covid-19 immunisation. The patient previously took the first dose bnt162b2 on 26Jan2021 at 43 years old for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced left shoulder became increasing sore over 24 hours on 16Feb2021 15:45, trouble falling asleep on 17Feb2021 04:00, general feeling of malaise, pressure building in my head and abdomen on 17Feb2021, felt a little colder than usual on 17Feb2021 08:30. No treatment was received for the adverse events. Under the tongue temperature reading was 97.9 (The patient was usually 97.5 with this thermometer) on 17Feb2021. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1070703
Sex: M
Age:
State: CT

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

Lab Data:

Allergies:

Symptoms: Body aches; injection site pain; low grade fever; This is a spontaneous report from a contactable consumer(patient). A 30-year-old male patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration at left arm on 16Feb2021 10:00 at the 30 years old at single dose for COVID-19 immunization. The medical history was not reported. The concomitant medications were Lisinopril and sertraline hydrochloride (ZOLOFT). The Historical Vaccine was first dose BNT162B2 on 26Jan2021 12:00 AM at 30 years old at Left arm for COVID-19 immunization. The patient experienced Body aches, injection site pain, and low-grade fever on 16Feb2021 22:00. There was no treatment received for all the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Other Meds: LISINOPRIL; ZOLOFT

Current Illness:

ID: 1070704
Sex: F
Age:
State: MO

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

Lab Data: Test Date: 20210216; Test Name: Temperature; Result Unstructured Data: Test Result:101; Comments: low grade fever 101 highest

Allergies:

Symptoms: low grade fever 101 highest; hot/cold flashes; hot/cold flashes; exhausted; overall body achy; sore arm at/around injection site; This is a spontaneous report from a contactable consumer. A 51-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EN 5318), via an unspecified route of administration at Left arm on 16Feb2021 08:45 at single dose for covid-19 immunisation. The patient medical history was not reported. Allergies to medications, food, or other products: none. Prior to vaccination, was the patient was not diagnosed with COVID-19. Concomitant medication included naproxen sodium (ALEVE) and multi vitamins. The patient previously received first dose of bnt162b2 on 26Jan2021 for covid-19 immunisation. The patient experienced low grade fever 101 highest, hot/cold flashes, exhausted, overall body achy, sore arm at/around injection site on 16Feb2021 12:30. No treatment received for the events. Outcome of events was recovering.

Other Meds: ALEVE

Current Illness:

ID: 1070705
Sex: F
Age:
State: CT

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

Lab Data:

Allergies:

Symptoms: nausea - 6hrs post shot; headache -10hrs; body aches-14hrs; chills - 14hrs; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on left arm on 16Feb2021 11:30 AM at single dose for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included hypothyroid, Allergies to amoxicillin and sulfa drugs. Concomitant medication (received within 2 weeks of vaccination) included levothyroxine sodium (SYNTHROID), buspirone hydrochloride (BUSPAR) and vitamin D. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation on 26Jan2021 at age of 35 years old. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Feb2021, the patient experienced nausea - 6hrs post shot, headache - 10hrs, body aches and chills - 14hrs. The outcome of events was not recovered. No treatment received for the adverse events. All events reported as non-serious. No follow-up attempts are possible. No further information is expected.

Other Meds: SYNTHROID; BUSPAR; VITAMIN D

Current Illness:

ID: 1070706
Sex: F
Age:
State: KS

Vax Date: 02/15/2021
Onset Date: 02/17/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Red rash on chest, back, neck, and arms (does not appear to be hives and does not itch); Two sudden, swollen nodules under my chin. Located in the center, almost directly under the center of my tongue. Very tender locally, externally; This is a spontaneous report from a contactable consumer, the patient. A 45-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:EN5318), via an unspecified route of administration in the left arm on 15Feb2021 at 09:00 (at the age of 45-years-old) as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a workplace clinic. Medical history included known Drug Allergy to: Sulfa and Cipro antibiotics.. Concomitant medication included buspirone (BUSPIRONE), bupropion (BUPROPION), vitamin c [ascorbic acid] (VITAMIN C), vitamin d vitamin d [nos] (VITAMIN D), vitamin b complex (VITAMIN B). Historical Vaccine BNT162B2 received on 25Jan2021 at 09:00 Dose 1, Lot Number EN5318 in Left arm. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 17Feb2021 at 07:00 The patient experienced red rash on chest, back, neck, and arms (does not appear to be hives, two sudden, swollen nodules under my chin, located in the center, almost directly under the center of my tongue, very tender locally, externally. The events were considered non serious. No treatment was given for the event. The clinical outcome of the event Red Rash and Lymph nodes cervical swollen was not recovered.

Other Meds: BUSPIRONE; BUPROPION; VITAMIN C; VITAMIN D; VITAMIN B

Current Illness:

ID: 1070707
Sex: F
Age:
State: NY

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

Lab Data:

Allergies:

Symptoms: abdominal cramping; diarrhea; sore arm day of injection (dose 2); This is a spontaneous report from a non-contactable consumer (patient). A 72-years-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration at arm left on 16Feb2021 at single dose for COVID-19 immunisation. Medical history included cirrhosis unknown origin, autoimmune disease/unknown origin and no known allergies. Concomitant medication included sertraline hydrochloride (ZOLOFT), omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included 1st of BNT162B2 on 26Jan2021. The patient experienced sore arm day of injection (dose 2) on 16Feb2021, abdominal cramping/diarrhea post dose day 2 (17Feb2021) vax 2. No treatment was received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. Information on the lot/batch number has been requested.

Other Meds: ZOLOFT; OMEPRAZOLE

Current Illness:

ID: 1070708
Sex: F
Age:
State: IL

Vax Date: 02/06/2021
Onset Date: 02/07/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: continued mild headache; eye strain and sensitivity to bright light; eye strain and sensitivity to bright light; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EM9810), via an unspecified route of administration in the left arm on 06Feb2021 at 10:15 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension (HTN), obstructive sleep apnoea (OSA), periodic limb movements of sleep (PLMS), arthritis, asthma, allergies to Band-aid adhesive, steristrips and lanolin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, but the patient did receive concomitant medications within 2 weeks of the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247) on 16Jan2021 at 16:30 (at the age of 60-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccinations within 4 weeks prior to the COVID-19 vaccination. On 07Feb2021 at 00:00, the patient experienced continued mild headache, eye strain and sensitivity to bright light. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of continued mild headache, eye strain and sensitivity to bright light was not resolved.

Other Meds:

Current Illness:

ID: 1070709
Sex: F
Age:
State: MO

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

Lab Data:

Allergies:

Symptoms: headache; on and off chills; lethargic; nasal congestion; started feeling run down; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received 2nd dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration in left arm on 16Feb2021 12:00 at single dose for covid-19 immunisation. Medical history included nocturnal seizures, hypothyroid, sinus infections, seasonal allergies, allergies to sulfa drugs. Concomitant medication included lamotrigine (LAMICTAL), levothyroxine, glucosamine, naproxen sodium (ALEVE), cetirizine hydrochloride (ZYRTEC). The patient previously received 1st dose of bnt162b2 on 26Jan2021 at 11:00 in left arm for covid-19 immunisation. At about 11 pm after the vaccination (16Feb2021 23:00), started feeling run down. Woke up the next morning (17Feb2021) with headache, on and off chills, lethargic, with nasal congestion. No treatment received in response to the events. The outcome of events was recovering. This case was reported as non-serious. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.

Other Meds: LAMICTAL; LEVOTHYROXINE; GLUCOSAMINE; ALEVE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1070710
Sex: F
Age:
State: SC

Vax Date: 02/12/2021
Onset Date: 02/01/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Date: 20210217; Test Name: body temperature; Result Unstructured Data: Test Result:101.1; Comments: fever

Allergies:

Symptoms: headache/ lingering headache; nausea; spells of dizziness/feeling extremely dizzy; feel like I am floating; fever of 101.1; chills; body aches; extreme fatigue; This is a spontaneous report from a contactable other health care professional (patient). A 23-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EM9810, intramuscular on 12Feb2021 14:15 (at the age of 23-years-old) as a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications were none. Historical vaccine information included BNT162B2 (Pfizer BioNtech), lot unknown False, administration date 22Jan2021 01:45 AM, dose number 1 for COVID-19 immunization (at 23 years old). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not have allergies to medications, food, or other products. The most recent COVID-19 vaccine was administered in a hospital. The patient reported she was on day 5 post second vaccine and am still experiencing a lingering headache, nausea and spells of dizziness. These ease up some with acetaminophen (TYLENOL), but do not fully go away nor has she noticed any improvement in her symptoms. The headache started approximately 11 hours after her vaccination 13Feb2021 01:15. The following day unspecified date Feb2021, she had fever of 101.1, chills, body aches, extreme fatigue, and a worsening headache. This headache has continued and is still present, coming and going in severity. She had spells where she feels like she was floating on unspecified date in Feb2021 and feeling extremely dizzy while also being nauseated. She has not seen any reports of these symptoms lasting this long after vaccination. "The adverse events started on 17Feb2021 at 12:00 PM". The patient underwent lab tests and procedures which included body temperature: 101.1 (fever) on 17Feb2021. No treatment was received for feel like I am floating, fever of 101.1, chills, body aches and extreme fatigue. Outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1070711
Sex: M
Age:
State: FL

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:Birth defect in his heart; Comments: The CT scan at the hospital showed a birth defect in his heart

Allergies:

Symptoms: stroke; Joint pain; In the palm of my hand I might jump out of my skin; ; arm was hardly sore at all; right arm at the shoulder, elbow, and fingers is hurting at the joints; This is a spontaneous report from a contactable consumer. This 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9269) single dose, dose 1 via unknown route of administration in the left arm for COVID-19 vaccination on 12Feb2021 at 14:30. There were no additional vaccines administered on the same date as the COVID-19 vaccine. Medical history included pneumonia five times on an unknown date, septicemia one time, melanoma cancer in 2015, Factor V Leiden, high blood pressure and blood thinner. Prior Vaccinations (within 4 weeks): Concomitant medications included lisinopril from 2008 and ongoing for high blood pressure and warfarin 9.5 mg daily from 2008 and ongoing for blood thinner. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On an unknown date, the patient's arm was hardly sore at all and he had a stroke. On 13Feb2021, the patient experienced joint pain, in the palm of his hand if he presses right in the dead center he thinks he is going to jump out of the skin and right arm at the shoulder, elbow and fingers is hurting at the joints. When he first felt it in his right arm it wasn't horrible and it seemed like it got worse the next day. Then it seemed like it tapered off a little bit. On 16Feb2021, the pain woke him up in the middle of the night. The events did not require an emergency room or physician's office visit. He gets the flu shot every year and he has no symptoms whatsoever. The clinical outcome of stroke, joint pain, in the palm of my hand I might jump out of my skin, arm was hardly sore at all and right arm at the shoulder, elbow, and fingers is hurting at the joints were unknown.

Other Meds: LISINOPRIL; WARFARIN

Current Illness:

ID: 1070712
Sex: M
Age:
State: MA

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

Lab Data:

Allergies:

Symptoms: fever; fatigue; headache; muscle pain; thirst; insomnia; This is a spontaneous report from a non-contactable other health professional (HCP) reported for himself. A 29-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration in the right arm on 16Feb2021 at single dose for COVID-19 immunization. The relevant medical history included covid-19 (if covid prior vaccination: Yes) from an unspecified date. Concomitant medications included chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX). The patient previously received first dose of BNT162B2 at the age of 28 years old on 27Jan2021 for COVID-19 immunization (lot number: EL3247, vaccine location: Right arm). The patient experienced fever, fatigue, headache, muscle pain, thirst, severe enough to cause insomnia and interfere with work on 16Feb2021. No treatment was received for the events. The seriousness was reported as non-serious. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: OSTEO BI-FLEX

Current Illness:

ID: 1070714
Sex: F
Age:
State: CA

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

Lab Data: Test Date: 202102; Test Name: blood work; Result Unstructured Data: Test Result:blood work indicated a blood clot; Test Date: 202102; Test Name: stress test; Result Unstructured Data: Test Result:unknown results; Test Date: 202102; Test Name: ultrasound; Result Unstructured Data: Test Result:unknown results; Test Date: 202102; Test Name: x-ray; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptoms: she was hospitalized 2.5 days after having symptoms of a "massive heart attack" 2 days after the vaccine; blood clot; pain on the left side/pain so bad/ pain was so severe couldn't bent over and couldn't get up; pain was in the heart and underneath the rib; pain was in the heart and underneath the rib; had a little trouble breathing; broke out in a sweat; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date in Feb2021 at a single dose for COVID-19 immunization. Medical history included asthmatic, had double pneumonia years ago, has ongoing atrial fibrillation and a pacemaker to control it as the only problem she has in her heart. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient was hospitalized for 2.5 days after having symptoms of a massive heart attack two days after the vaccine. It was reported that two days post vaccination, the patient was rushed to the hospital by ambulance as they thought she was having a massive heart attack. She added her symptoms lasted for hours, she had pain so bad that she was bent over and had a little trouble breathing. She said the pain was in the heart and underneath the rib, on the left side. She later mentioned she did not feel like it was AFib. She said they did every test possible and listed the following ones: ultrasound, stress test, x-ray (unknown results), and blood work in Feb2021. She specified that her blood work indicated a blood clot. She mentioned she was told by her personal friend, who was a doctor, that by having the shot sometimes it indicated you have blood clots when you really don't. The patient also specified that she broke out in a sweat, the pain was so severe that she could not bend over and could not get up; therefore, they treated her as if she was having a massive heart attack for 12 hours at the hospital. It was reported that they kept giving her stuff to stop the effect with her heart. She mentioned her second dose was scheduled on 25Feb2021. She asked if her experience was reported as a side effect to the vaccine and should she get the second dose of the vaccine. She explained the doctors did not know what she had, and she needed to determine if she can receive the second dose. She also asked if we could notify her if a similar reaction is reported. The outcome of the events was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness: Artificial cardiac pacemaker user; Atrial fibrillation

ID: 1070715
Sex: F
Age:
State: MN

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Date: 20210217; Test Name: fever; Result Unstructured Data: Test Result:low grade; Test Date: 20210217; Test Name: heart beat; Result Unstructured Data: Test Result:rapid heart beat

Allergies:

Symptoms: had tunnel vision ups on walking to bathroom and almost blacked out; had tunnel vision ups on walking to bathroom and almost blacked out; Achy and restless legs; Achy and restless legs; nauseous however did not allow self to vomit; headache; fatigue; rapid heart beat; low grade fever; chills; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EM9809) via an unspecified route of administration on 16Feb2021 12:45 at single dose (left arm) for COVID-19 immunization. Medical history included hypothyroidism, and allergies: Sulfa. The patient was not pregnant. Concomitant medication included topiramate (TOPIMAX), metformin, levothyroxine, and phentermine. The patient received 1st dose of bnt162b2 for COVID-19 immunization on 26Jan2021, 12:45pm (lot EL9263). On 17Feb2021 03:30, the patient experienced achy and restless legs, nauseous however did not allow self to vomit, had tunnel vision ups on walking to bathroom and almost blacked out, headache, fatigue, rapid heart beat, low grade fever, and chills. The patient had no treatment for the events. The patient had no other vaccine in four weeks and had no covid prior vaccination. Patient was not covid tested post vaccination. Outcome of events was recovering.; Sender's Comments: A possible contribution role of the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of Tunnel vision cannot be completely excluded due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: TOPIMAX [TOPIRAMATE]; METFORMIN; LEVOTHYROXINE; PHENTERMINE

Current Illness:

ID: 1070716
Sex: M
Age:
State:

Vax Date: 02/06/2021
Onset Date: 02/18/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Date: 20210218; Test Name: CT scan; Result Unstructured Data: Test Result:normal; Comments: He went to the doctor, got a CT scan and other studies, everything is normal, doctor said it was probably the vaccine; Test Date: 20210218; Test Name: other studies; Result Unstructured Data: Test Result:normal; Comments: He went to the doctor, got a CT scan and other studies, everything is normal, doctor said it was probably the vaccine

Allergies:

Symptoms: face paralysis; This is a spontaneous report from a contactable consumer reporting on behalf of her husband. A 43 year old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 06Feb2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medications were not reported. The reporter stated her husband received the first dose of the COVID 19 vaccine on 06Feb2021 and was scheduled for the second dose on 19Feb2021 He woke up today (18Feb) with face paralysis. He went to the doctor, got a CT scan and other studies, and everything is normal. The reported stated that the doctor said it was probably the vaccine. Doctor prescribed medication and told him not to get the second dose. Lab data included CT scan and "other studies" on 18Feb2021 which were normal. The clinical outcomes of facial paralysis was unknown.

Other Meds:

Current Illness:

ID: 1070717
Sex: M
Age:
State: IL

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

Lab Data: Test Name: Covid-19; Result Unstructured Data: Test Result:Negative; Comments: He tested negative [for Covid-19] the first two times and then was positive when they were going to send him to rehab; Test Name: Covid-19; Result Unstructured Data: Test Result:Negative; Comments: He tested negative [for Covid-19] the first two times and then was positive when they were going to send him to rehab; Test Name: Covid-19; Result Unstructured Data: Test Result:Positive; Comments: He tested negative [for Covid-19] the first two times and then was positive when they were going to send him to rehab

Allergies:

Symptoms: in hospital because he caught the covid virus; pneumonia; positive when they were going to send him to rehab; positive when they were going to send him to rehab; This is a spontaneous report from contactable consumers (patient's wife and son). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified as a SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (it was just under 100 days since he had COVID). The patient's concomitant medications were not reported. The consumer reported her husband is in hospital because he caught the covid virus on an unknown date. The consumer was with her son who added some additional information stating that at first they had his father in the hospital because he had pneumonia on unknown date. He tested negative [for Covid-19] the first two times and then was positive when they were going to send him to rehab. They think it was false positive because it was just under 100 days since he had COVID and he didn't have any symptoms. They say you can test for Covid-19 4 or 5 months after Covid and still test positive. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1070718
Sex: F
Age:
State: MI

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Bleeding upon injection; large bruise; extreme nausea; chills; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) solution for injection, via an unspecified route of administration at right arm on 11Feb2021 at 4:15 PM at single dose for COVID-19 immunization. Medical history included allergies to penicillin, glaucoma (reported as glaucomo) and high blood pressure. Concomitant medication included metroprolol. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 20Jan2021 at single dose for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at a hospital. There was no other vaccine in four weeks. The patient was no COVID prior to vaccination and she was not tested for COVID post vaccination. The patient experienced bleeding upon injection, large bruise, extreme nausea, chills, fatigue, and headache, all on 12Feb2021 at 04:00 AM. She did not receive any treatment in response to the events. The outcome of the events was recovering.

Other Meds: METOPROLOL

Current Illness:

ID: 1070719
Sex: F
Age:
State: GA

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: brain pain and the neck pain being a possible encephalitis; some nodules under the arm and leg; right shoulder pain at the site of an old shoulder injury; pain under her arm and into her right breast that started on Saturday with nodules; nodules in her right leg that hurt; headache at the base of her brain and in front; intense neck pain; joints aching/all her joints ache; felt queasy; had sharp pain in both eyes; brain fog; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EM9810) , via an unspecified route of administration on 09Feb2021 at 11:30 (at the age of 67 years old) on left arm at single dose for covid-19 immunisation at a mall vaccination facility. The patient medical history was none. There were no concomitant medications. The patient stated she had some pretty severe reactions after getting the first dose of the Pfizer COVID 19 vaccine on 09Feb2021 at 1130AM in the left arm. The patient experienced "brain pain and the neck pain being a possible encephalitis" on an unspecified date with outcome of unknown , intense neck pain on 10Feb2021 to 13Feb2021 with outcome of recovered , joints aching/all her joints ache on 10Feb2021 to 18Feb2021 with outcome of recovered , felt queasy on 10Feb2021 to 12Feb2021 with outcome of recovered , had sharp pain in both eyes on 10Feb2021 to 12Feb2021 with outcome of recovered , brain fog on 10Feb2021 to 13Feb2021 with outcome of recovered , some nodules under the arm and leg on 13Feb2021 with outcome of not recovered , headache at the base of her brain and in front on 10Feb2021 to 13Feb2021 with outcome of recovered , right shoulder pain at the site of an old shoulder injury on 13Feb2021 to 13Feb2021 with outcome of recovered , pain under her arm and into her right breast that started on Saturday with nodules on 13Feb2021 and ongoing with outcome of recovering, and nodules in her right leg that hurt on 13feb2021 with outcome of not recovered. She was afraid of getting the second dose and inquired advice about getting the second shot. Relevant tests were none.

Other Meds:

Current Illness:

ID: 1070720
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: seeing people/things that are not there; having psychosis issues; This is a spontaneous report received from a contactable consumer via a Pfizer-sponsored program. This consumer reported for a patient (father) that: A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on an unknown date in Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller states that his dad had the first dose of the COVID-19 Shot a little over two weeks ago in Feb2021. Caller stated that lately in Feb2021, his dad was having psychosis issues, and was seeing people/things that are not there. The outcome of the events was unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1070721
Sex: F
Age:
State: CA

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Date: 20210202; Test Name: Lab work; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: She did have an inflamed shoulder prior, it has been pretty good lately but flared up after the vaccine/She does have rheumatoid arthritis in right shoulder and arm; right shoulder and right arm felt sore and achy/ right arm and shoulder were aching; right shoulder and right arm felt sore and achy/ right arm and shoulder were aching; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection lot number: EN6201), intramuscular at upper left arm on 17Feb2021 10:15 at a single dose for COVID-19 immunization. Medical history included ongoing Rheumatoid arthritis (arthritis in right shoulder and arm gets inflamed and sore; rheumatoid arthritis in right shoulder and arm. It sometimes flares up and gets sore) diagnosed in late 2019, ongoing Autoimmune deficiency disease diagnosed in late 2019 and lower left eyelid which was inverted. There were no concomitant medications. No prior vaccinations (within 4 weeks). The patient previously took Shingrix vaccine (Shingles vaccine) at left arm last year-2020 and she felt soreness and achiness in right shoulder and arm. The patient received the first dose of the Pfizer COVID-19 vaccine yesterday on 17Feb2021 at her left arm. A few hours later her right shoulder and right arm felt sore and achy. On 18Feb2021, the patient's right arm and shoulder were aching. The patient mentioned that this has also happened last year when she had a Shingrix vaccine. She was also injected in her left arm but her right arm got sore and achy. She felt soreness and achiness in right shoulder and arm. She wanted to know if this is a normal reaction from the vaccine. The patient stated that it was weird. On unspecified date, when she lifts her arm up high it hurts, she stated that she does have an inflamed shoulder. She did have an inflamed shoulder prior, it has been pretty good lately but flared up after the vaccine. During the night it was very bad. She does have rheumatoid arthritis in right shoulder and arm. It sometimes flares up and gets sore. She was wondering if there is a relationship with the COVID 19 vaccine because she felt like she got the COVID 19 vaccine in the right arm, she asked if she's reacting to the medication. No treatment was administered for right shoulder. Routine lab work done on 02Feb2021 but it has nothing to do with this. The events did not require a visit to Emergency Room or Physician Office. The patient is also scheduled to have Botox in her lower eyelid for her left eye to release the nerve muscle. She asked if it is ok since she just had the Pfizer COVID-19 vaccine. She is scheduled to get botox injection next week for lower left eyelid which is inverted, it was bothering her. They have to release the muscle by getting an injection of botox. She was receiving conflicting information from her PCP, who says wait a month and her ophthalmologist who says its ok to get the COVID 19 vaccine. She thought she heard something about not mixing botox with the vaccine. The outcome of the event "She did have an inflamed shoulder prior, it has been pretty good lately but flared up after the vaccine/She does have rheumatoid arthritis in right shoulder and arm" was unknown; and other events was recovering.

Other Meds:

Current Illness: Autoimmune deficiency syndrome; Rheumatoid arthritis

ID: 1070722
Sex: F
Age:
State:

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

Lab Data: Test Name: fever; Result Unstructured Data: Test Result:99.46 Fahrenheit; Comments: My fever never got higher than 99.46F

Allergies:

Symptoms: felt like I was getting COVID again; felt like I was getting COVID again; could barely walk; chills; nauseated; wasn't breathing well; swollen, red cheeks; red cheeks; headache; constant pain in my body; fever never got higher than 99.46F; A 94-years-old female patient received the first dose of dose 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. Medical history included covid-19 from Mar2020. Concomitant medication included Tylenol and Tramadol. The patient reported that the evening I got the first dose, I had chills for 24 hours, I was nauseated, I wasn't breathing well. I had swollen, red cheeks. My fever never got higher than 99.46F. I called because I could barely walk. I went to the hospital. I felt like I was getting COVID again. I took me about 3 days to get over the side effects. I had a bad headache. I told the doctor in the ER my problem and he asked why I thought it was reaction. I'm 94 years old. I take Tylenol every day. I take Tramadol for constant pain in my body. I finally just told them I wanted to go home; they weren't doing anything for me at the hospital. The outcome of the events chills, nauseated, wasn't breathing well, swollen, red cheeks, fever never got higher than 99.46F, I could barely walk, felt like I was getting COVID again, bad headache was unknown. Information on Lot/Batch number requested

Other Meds: TYLENOL; TRAMADOL

Current Illness:

ID: 1070723
Sex: M
Age:
State: FL

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 03/03/2021
Hospital: Y

Lab Data: Test Name: covid tested; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: Coughing; wheezing; shortness of breath; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 90 years, first dose on 19Jan2021 09:00 (lot number: EK4176) and second dose on 09Feb2021 (lot number EL9261); via unspecified routes of administration on the left arm at single doses for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included losartan, terazosin, melatonin, glipizide, linagliptin (TRAJENTA), clopidogrel bisulfate (PLAVIX), clopidogrel bisulfate, citalopram, zinc, famotidine, amino acids nos (PROTINEX) and colecalciferol (VITAMIN D). On 20Jan2021, the patient experienced coughing, wheezing and shortness of breath. The patient was taken to the ER and put in the hospital for five days (date of hospitalization was unknown). Treatment received by the patient was unknown. Lab data includes COVID test: Unknown results on an unspecified date. The outcome of the events was recovered with sequelae on an unspecified date.

Other Meds: LOSARTAN; TERAZOSIN; MELATONIN; GLIPIZIDE; TRAJENTA; PLAVIX; CLOPIGREL; CITALOPRAM; ZINC; FAMOTIDINE; PROTINEX; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1070724
Sex: F
Age:
State:

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

Lab Data: Test Name: platelets; Result Unstructured Data: Test Result:below 30,000

Allergies:

Symptoms: acute myeloid leukemia; her platelets were below 30,000; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 12Feb2021 at single dose for COVID-19 immunization. Medical history included ongoing immunodeficiency (reported as immunocompromised). Concomitant medications were not reported. The patient had an acute myeloid leukemia and her platelets were below 30,000 on an unspecified date. Clinical outcome of the events was unknown. Information on about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1070725
Sex: F
Age:
State: NY

Vax Date: 01/27/2021
Onset Date: 01/01/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Date: 202010; Test Name: COVID test; Result Unstructured Data: Test Result:positive test; Comments: COVID test type is unknown

Allergies:

Symptoms: shaking; chills; headache; diarrhea; overall body aches; This is a spontaneous report from a contactable pharmacist. A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 vaccination. Medical history included she was previously positive for Covid in Oct2020 to an unspecified date and she received monoclonal antibody treatment (Remdesivir) 3 months prior to her first dose of the vaccine; patient had COPD, oxygen dependent and diabetes from 2016 to an unknown date; and obesity in 2014 to an unknown date. There were no concomitant medications which was reported as patient had not had any other recent vaccinations or started any new medications. Patient received monoclonal antibody treatment 3 months prior to her first dose of the vaccine. Patient probably tested positive and was treated probably the same day she had the positive test (in Oct2020), reporter was sure all of this happened at the hospital, but he doesn't have that information, and the COVID test type was unknown. Reporter's question was related to information about this specific type of patient, having received the monoclonal antibody treatment on 12Oct2020, to an unknown date, which was Remdesivir and also having had COVID then, then having reactions to the dose, would the second dose be necessary, effective, or safe to give to this patient. The patient had her first dose of the Pfizer Covid vaccine 3 weeks ago (estimated as 27Jan2021 by standing order and not prescribed). The patient had general same symptoms listed for side effects of the vaccine that were more severe than others. The patient experienced effects after the first dose of the vaccine as shaking and chills for two days, and headache, diarrhea, and overall body aches (Jan2021). Reporter wanted to know of any studies or research on patients who have been positive for Covid 19 prior to getting the vaccine and treated with monoclonal antibodies and if they do have similar titers to those who have been vaccinated. The reporting pharmacist that the events were serious, and he thought these were medically significant. The patient's symptoms resolved after 72 hours, and reporter did not believe that they did any treatment other than to sleep. The events recovered on an unspecified date in 2021. Information about Lot/ Batch number requested; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events tremor, chills, headache, diarrhoea and pain cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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:

Current Illness:

ID: 1070726
Sex: M
Age:
State: PA

Vax Date: 01/18/2021
Onset Date: 01/21/2021
Rec V Date: 03/03/2021
Hospital: Y

Lab Data: Test Date: 20210121; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: Had severe chest pains and pain radiating down left arm three (3) days; Had severe chest pains and pain radiating down left arm three (3) days; I was diagnosed with myopericarditis (inflammation of both the lining of the heart and the heart muscle); This is a spontaneous report from a contactable consumer. This 28-year-old male consumer reported that: Report about Covid vaccine: Yes Reporting type: AE Reporter type: Patient Age group: Adult (18-64 Years) Current age: 28 Current age unit: Years Gender: Male Patient occupation: None of the above Covid vaccine details: (product=COVID 19, brand=Pfizer, lot number=EL3246, lot unknown= False, administration date=18Jan2021, administration time= 04:00 PM, vaccine location= Right arm, dose number= 2), (product= COVID 19, brand=Pfizer, lot number= EJ1685, lot unknown= False, administration date= 29Dec2020, administration time=11:00 AM, vaccine location= Right arm, dose number=1) Facility type vaccine: Hospital If other vaccine in fourweeks: No Other medications in twoweeks: No Adverse event: Had severe chest pains and pain radiating down left arm three (3) days (Thursday 21Jan2021) after receiving the second Pfizer COVID vaccine (lot:EL3246) on Monday 18Jan2021. I was admitted to the hospital the same day, and was discharged on Saturday 23Jan2021. I was diagnosed with myopericarditis (inflammation of both the lining of the heart and the heart muscle). I was given a 90 day prescription of colchicine 0.6mg and I am still currently taking the medication twice daily with 1g of Tylenol (acetaminophen) once daily. Adverse event start date: 21Jan2021 Adverse event start time: 03:00 AM AE resulted in: [Emergency room/department or urgent care, Hospitalization] No days hospitalization: 3 If patient recovered: Recovered If treatment AE: Yes AE treatment: Colchicine 0.6 mg tablet (twice daily) If Covid prior vaccination: No If Covid tested post vaccination: Yes Covid test post vaccination: (covid test type post vaccination=Nasal Swab, covid test date=21Jan2021, covid test result=Negative) Known allergies: Penicillin/Amoxicillin Other medical history: No

Other Meds:

Current Illness:

ID: 1070727
Sex: M
Age:
State: CA

Vax Date: 02/04/2021
Onset Date: 02/06/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: optic neuritis; This is a spontaneous report from a contactable physician. A 65-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. Medical history included lost vision in one eye on unspecified date, 20 years ago in the military. Concomitant medications were not reported. After 2 days, on 06Feb2021, the patient developed severe optic neuritis in one eye. Event was assessed as serious, medically significant. The patient is getting a fairly extensive workup. He was getting labs (unspecified) and will get 1 gram a day of Solumedrol for three days followed by oral Prednisone. He was going to get the typical. Outcome of the event was unknown. Information on Lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1070728
Sex: M
Age:
State: SC

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Name: fever; Result Unstructured Data: Test Result:low grade fever

Allergies:

Symptoms: Became unresponsive for a short period on the way to the ER after vomiting; Became so sick and weak within 2 hours needed to seek medical help at the ER; Became so sick and weak within 2 hours needed to seek medical help at the ER; Uncontrollable cough; low grade fever; muscle aches; nausea; violent projectile vomiting; This is a spontaneous report from a contactable consumer (patient) A 75 years old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 12Feb2021 at 14:30 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included lung cancer on 2007, Covid 19 infection on an unspecified date prior vaccination. The patient received first dose of BNT162B2 on 21Jan2021 at 15:00 in left arm. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and pravastin. On 13Feb2021 at 13:00 the patient started experiencing uncontrollable cough, low grade fever, muscle aches, nausea, violent projectile vomiting. He became so sick and weak within 2 hours needed to seek medical help at the ER. It was also informed that patient became unresponsive for a short period on the way to the ER after vomiting. Treatment received included Zofran, LR (IV fluids). The patient recovered from became unresponsive on 13Feb2021. At the time of the reporting the patient was recovering from the events. Information on the lot/batch number has been requested.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; PRAVASTATIN

Current Illness:

ID: 1070729
Sex: F
Age:
State: NY

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: heard a loud bang in my brain; blacked out for an instant; tired and wobbly; Did not get my balance/wobbly; 1,Day after the vaccine, I had violent projectile diarrhea; This is a spontaneous report from a contactable consumer (patient). An 83 year-old elderly female patient received first dose of BNT162B2 (lot number: EL3247), via an unspecified route of administration from 20Jan2021 20:30 at single dose in the right arm for COVID-19 immunisation. Medical history included small cell lung, 2cm, no follow -up treatment necessary. No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID), and losartan potassium. One day after the vaccine administration on 21Jan2021 10:00, the patient had violent projectile diarrhea. Two days after the vaccine, she blacked out for an instant and heard a loud bang in her brain. She was tired and wobbly for over one week. She did not get her balance back for nearly 3 weeks. The events resulted in Disability or permanent damage. Treatment for the events was unknown. 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. The outcome of the events was not recovered.

Other Meds: SYNTHROID; LOSARTAN POTASSIUM

Current Illness:

ID: 1070730
Sex: F
Age:
State: MO

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: hands, feet, toes and entire body, felt almost paralyzed; not being able to turn over in bed; could not bend her fingers or toes; muscles throughout her body remained stiff and tight; could not bend her fingers or toes; muscles throughout her body remained stiff and tight; tense muscle aches; Chills; headache; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) at the age of 72-years, via an unspecified route of administration in left arm at 11:00 AM on 16Feb2021 at single dose for COVID-19 immunisation, in hospital. Medical history included pituitary microadenoma from 1969 (52 years) and in good health other than the fibromyalgia; allergies to latex. Patient was not pregnant, was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included desipramine; duloxetine hydrochloride (CYMBALTA); ergocalciferol (VIT D); zinc. The patient previously received first single dose of BNT162B2 (lot number: EK9231) at the age of 72-years via an unspecified route of administration in left arm at 04:00 PM on 25Jan2021 for COVID-19 immunisation. Patient reported that she had been diagnosed with fibromyalgia and saw a rheumatologist that specializes in treating fibromyalgia. At 01:00 AM on 17Feb2021, fourteen hours later, she awoke to not being able to turn over in bed. Her hands, feet, toes and entire body, felt almost paralyzed. She could not bend her fingers or toes. Her muscles throughout her body remained stiff and tight for the next 16 hours. Chills, headache but no fever. Patient took paracetamol (TYLENOL) every four hours, during this time. It did not help with the tense muscle aches. Later on 17Feb2021 (that same day), approximately 19:00 (7:00 PM), her muscles started to relax. Patient was writing this the day after and she felt fine. She could hardly wait for the booster shot. Outcome of the events was recovered/resolved in Feb2021. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds: DESIPRAMINE; CYMBALTA; VIT D; ZINC

Current Illness:

ID: 1070731
Sex: M
Age:
State: UT

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

Lab Data:

Allergies:

Symptoms: Guillan Barre Syndrome; This is a spontaneous report from a contactable consumer (patient) via the Pfizer sponsored program. A male patient of an unspecified age received pneumococcal 13 valent conjugate vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date at a single dose for immunisation and influenza vaccine (FLU), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took atorvastatin (LIPITOR) in which his doctor overdosed him with, so he developed a liver problem. It was reported that the patient was planning on receiving the Pfizer-BioNTech Covid-19 Vaccine. However, he said he was concerned about getting it since he had a history of having a reaction with the flu and pneumonia shot. He said his doctor overdosed him with LIPITOR so he developed a liver problem. So when his doctor gave him the flu and pneumonia shot, he ended up getting Guillan Barre Syndrome on an unspecified date with unknown outcome. He wanted to know if it would still be safe for him to receive the vaccine considering this, and his weakened immune system. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1070732
Sex: M
Age:
State: NC

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

Lab Data: Test Date: 20210212; Test Name: Potassium level; Result Unstructured Data: Test Result:3.3; Comments: potassium level went down to 3.3; Test Date: 20210128; Test Name: Potassium level; Result Unstructured Data: Test Result:normal; Test Date: 20210212; Test Name: CBC; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210212; Test Name: Basic Metabolic Panel; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210212; Test Name: platelets; Result Unstructured Data: Test Result:141; Comments: his platelets dropped to 141.; Test Date: 20210128; Test Name: platelets; Result Unstructured Data: Test Result:181

Allergies:

Symptoms: had a feeling of impending death and thought he was gonna die.; Syncopal episode; My platelets counts drop; metallic taste; Potassium level went down; This is a spontaneous report from a contactable nurse (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) first dose on 12Feb2021 on Deltoid Left at single dose for covid-19 immunisation. Medical history included Covid-19 and High cholesterol. Concomitant medications were not reported. He said that he was 60 days post COVID and his doctor advised him to get vaccinated. He was feeling fine, but after 10 minutes into the shot, he had a metallic taste in the mouth. After 12-13 minutes, he had a feeling of impending death and thought he was gonna die. It freaked him out. He was rushed to the ER and had a complete blood count (CBC) and Basic Metabolic Panel (BMP) test run on him. It was that his Potassium level went down to 3.3 and his platelets dropped to 141. He had tests on 28Jan2021 and mentioned that his Potassium levels were normal and had a platelet count of 181. He mentioned that there was no other way but the vaccine that could have caused this. He is if he would already have passed away from the shot from his opinion. Patient had a Syncopal episode of some type. He had an intended feeling like he was going to die after the shot, he was 60 days post Covid when he get that shot, he was getting over Covid and he was 60 days and he didn't wait the 90 days his primary doctor care told me that he can get it too because he was feeling better which he was feeling better but since then he have gotten that shot, he went to the doctor on the 28Jan2021 and he had CBC drawn on him and he went for his regular physical and Covid follow-up at his doctor, his platelets counts drop since he have had shot struck at 40 points, feels concerning. The outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "feeling of impending death and Syncopal episode " and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1070733
Sex: F
Age:
State: NC

Vax Date: 01/08/2021
Onset Date: 01/11/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: miscarriage; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose on 08Jan2021 in right arm and 1st dose on 15Dec2020 in left arm, both via intramuscular at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient previously took amoxicillin and experienced allergy. Concomitant medication included prenatal vitamins. The patient experienced miscarriage on 11Jan2021 with outcome of recovered. The event resulted in doctor or other healthcare professional office/clinic visit. The mother reported she became pregnant while taking bnt162b2. The mother was 11 weeks pregnant at the onset of the event. The mother was due to deliver on 07Aug2021. Date of LMP was 26Oct2020. Therapeutic measures were taken as a result of miscarriage included misoprostol (CYTOTEC). Information of lot/batch number has been requested.; Sender's Comments: The limited information provided precludes a full clinical assessment of the case. Considering the product-event temporal relationship, a causal association between the reported 'miscarriage' and the administration of bnt162b2 cannot be completely excluded. Case will be reassessed once with additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1070734
Sex: F
Age:
State: OH

Vax Date: 01/22/2021
Onset Date: 02/16/2021
Rec V Date: 03/03/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: fall; This is a spontaneous report from a contactable consumer (patient's daughter). A 100-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9261) via an unspecified route of administration in left arm on 22Jan2021 at single dose for COVID-19 immunisation. There were no relevant medical history or concomitant medications (it was also reported that the patient was on a lot of different medications). The patient experienced fall on 16Feb2021. The patient was then "hospitalized for a fall" and might not be attend her second vaccination appointment. Her second dose was scheduled on 24Feb2021. The hospitalization had nothing to do with vaccine. The outcome of event was not recovered.

Other Meds:

Current Illness:

ID: 1070735
Sex: F
Age:
State: MI

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: I passed out going down stairs; woke up disoriented; weak; dizzy; bloody nose; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received her second single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine, lot number EM9810) at her left arm, at 11:00AM 17Feb2021, for Covid-19 immunization. The patient received her first injection (Lot number EL9765) on 27Jan2021 10:15AM at her left arm. The patient's medical history was not reported. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient was fine for 10 hours afterwards, went to bed, woke up disoriented weak and dizzy. She passed out going down stairs, came to on the floor at the bottom of the stairs, bloody nose, about an hour later passed out again in the kitchen and woke up on the floor. No warning either time, like light switch being turned off. The patient never had a reaction to anything before, never passed out before. She felt better at time of reporting. The adverse events happened at 07:00 AM 18Feb2021. The patient had not received any treatment for the events and not covered from the events. The patient had no Covid prior vaccination and Covid was not tested post vaccination.

Other Meds:

Current Illness:

ID: 1070736
Sex: F
Age:
State: FL

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

Lab Data:

Allergies:

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

Other Meds: ROSUVASTATIN; OLMESARTAN MEDOXOMIL

Current Illness:

ID: 1070737
Sex: F
Age:
State: AL

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

Lab Data: Test Name: Sugar; Result Unstructured Data: Test Result:her blood sugar was 250-280; Test Date: 20210212; Test Name: Sugar; Result Unstructured Data: Test Result:her sugar dropped to 25; Test Date: 20210212; Test Name: Sugar; Result Unstructured Data: Test Result:next reading was 47; Test Date: 20210212; Test Name: Sugar; Result Unstructured Data: Test Result:third reading was mid 90s; Test Name: blood tests; Result Unstructured Data: Test Result:did not find anything abnormal

Allergies:

Symptoms: became almost non-responsive/nearly totally nonresponsive; her blood sugar went down to 25; she was tired; This is a spontaneous report from a contactable consumer. A 69-year-old female patient (reporter's wife) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EN5318) on 12Feb2021 on right arm at a single dose for COVID-19 immunisation. Medical history included diabetes diagnosed about 30 years prior. Concomitant medications were none. Patient got the 1st dose of bnt162b2 and 4 hours after getting it, her blood sugar went down to 25 (12Feb2021) and she became almost non-responsive. She took a lot of carbohydrates after the shot before she plummeted. Reporter asked if there had been any reports of this and should she take the 2nd shot. Reporter said that he is reporting the side effect of that approximately 4 hours after receiving the shot, which his wife is diabetic, she was tired and then her sugar dropped to 25 before he realized she had an issue. He says she was nearly totally nonresponsive (12Feb2021). He said this was very abnormal and her sugar has never been that low. He said after he realized her sugar dropped to 25, he got some ice cream into her and then some (brand name withheld), then he got her blood sugar which the next reading was 47, then the third reading was mid 90s, so then he took her to the emergency room and they ran tests. He says by then her blood sugar was 250-280, which they thought was good after it had been that low. He says that they did blood tests and did not find anything abnormal, and her blood sugar has been good since then. He said she was not admitted to the hospital, and they went home that night. He said that this had never occurred before, period. Reporter said that everything seems to be normal at this point, though it scared them. He said his wife has not gotten the second dose yet, and they have questioned if she should take the second dose since this happened, and he was wondering if Pfizer may have advice to provide them on getting the second dose for her. The outcome of events was recovered on an unspecified date.

Other Meds:

Current Illness:

ID: 1070738
Sex: M
Age:
State: SC

Vax Date: 02/12/2021
Onset Date: 02/01/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Date: 20210219; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Unknown Results; Comments: Pending

Allergies:

Symptoms: feel like what I have is spreading from my sinuses to my chest (respiratory infection); nausea; loose stools; headache; chills; nasal drainage; sore throat; sinus congestion; hiccups lasting 2+days and still continuing; tiredness; minor soreness at the injection site; This is a spontaneous report from a contactable consumer report for self. A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration in left arm on 12Feb2021 12:15 at single dose for covid-19 immunisation. Medical history included Coronary artery disease requiring stenting, under the care of an Allergist for past 46 years. No Covid prior vaccination. No other vaccine in four weeks. Concomitant medications in two weeks include Atorvastatin Calcium, acetylsalicylic acid (ASPRIN), fexofenadine hydrochloride (ALLEGRA), Clopidogrel. An unspecified date in Feb2021 11:00 PM, patient experienced nausea, loose stools, headache, chills, nasal drainage, sore throat, sinus congestion, hiccups lasting 2+ days and still continuing, tiredness, minor soreness at the injection site but just for the first couple of days which was expected, feel like what have is spreading from sinuses to chest (respiratory infection) which concerns. The outcome of events was not recovered. Treatment not received. Covid Nasal Swab tested post vaccination on 19Feb2021, test result pending.

Other Meds: ATORVASTATIN CALCIUM; ASPRIN; ALLEGRA; CLOPIDOGREL

Current Illness:

ID: 1070739
Sex: M
Age:
State: NJ

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

Lab Data:

Allergies:

Symptoms: severe sinus pressure; severe chills; nausea; pain at injection site; This is a spontaneous report from a contactable consumer(Patient). A 25-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and known allergies reported as none. The patient's concomitant medications were not reported. The patient experienced severe sinus pressure, nausea, severe chills, pain at injection site on 16Feb2021. No treatment received. The outcome of the events were recovering. There was no Covid prior vaccination. No Covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1070740
Sex: M
Age:
State: MN

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

Lab Data:

Allergies:

Symptoms: developed pneumonia; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first Pfizer vaccine shot on 03Feb2021 and was due to receive 2nd dose on 24Feb2021. 2 weeks after receiving his 1st vaccine dose, patient developed pneumonia and is currently in the hospital. Patient was hospitalized. The outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1070742
Sex: F
Age:
State: WV

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

Lab Data:

Allergies:

Symptoms: fell on the ice; broke hip, arm and her wrists; broke hip, arm and her wrists; broke hip, arm and her wrists; This is a spontaneous report from a contactable consumer report for self from a Pfizer Sponsored Program . This 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunization. None medical history nor other products. The patient received the first vaccine on the 03Feb and she is scheduled to get the second one on 24Feb and about a week after the first dose she fell on the ice at her house and broke hip, arm and her wrists and had to have surgery. Her admission into the hospital was 09Feb2021. She had surgery on the 10Feb. She was discharged home 13Feb2021. She lost enough blood in surgery that she had to have 2 units of blood transfusion, she said the blood transfusions on 11Feb2021. She wanted to know is it safe to get the second vaccine after having those transfusions.

Other Meds:

Current Illness:

ID: 1070743
Sex: M
Age:
State: FL

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

Lab Data: Test Name: COVID-19; Test Result: Positive ; Comments: About 8 days after the shot

Allergies:

Symptoms: tested positive to COVID-19/wasn't feeling right, had a cold, stuffed nosed, throat was bad, and 3 days after he has soreness in his throat; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (reporting for son). A 54-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter's son (the patient) received the first dose of the Pfizer-BioNtech COVID-19 vaccine on an unknown date. Two (2) days later he wasn't feeling right, had a cold, stuffed nosed, throat was bad, and 3 days after he has soreness in his throat. About 8 days after the shot, he tested positive to COVID-19. He was asked to quarantine for 10 days and will have a second COVID-19 test then. His breathing was ok. He will probably have to wait 3 months for his second shot. The doctor told him it might be a false read. The event was reported as non-serious. The outcome of the event "tested positive to COVID-19/wasn't feeling right, had a cold, stuffed nosed, throat was bad, and 3 days after he has soreness in his throat" was uknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1070744
Sex: M
Age:
State: FL

Vax Date: 01/25/2021
Onset Date: 01/28/2021
Rec V Date: 03/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Hallucinations after both doses; This is a spontaneous report from a contactable consumer. A 95-year-old male patient received bnt162b2 (BNT162B2, lot number unknown), via an unspecified route of administration, first dose on 25Jan2021 10:00, second dose (Lot number=En6021) on 17Feb2021 12:30, both at Left arm, at single dose, for COVID-19 immunisation. Medical history included High cholesterol from an unknown date. No other vaccine in four weeks. There is other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies. The patient experienced hallucinations after both doses on 28Jan2021. On 28Jan2021, 3 days after first vaccine he began having hallucinations that lasted for two days. 19Feb2021, 2 days after second vaccine he began having hallucinations. This is being reported at the moment so the reporter cannot say what the end date will be. No treatment AE. The outcome of the event was recovered in Jan2021 for the first time . Information on Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1070745
Sex: F
Age:
State: SC

Vax Date: 02/10/2021
Onset Date: 02/12/2021
Rec V Date: 03/03/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: pain at injection site; swelling; warmth; redness; This is a spontaneous report from a contactable nurse. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EM9810) via intramuscular in the left arm on 10Feb2021 13:15 at single dose for covid-19 immunisation. Medical history included hypothyroid. Known- allergies included sulfamethoxazole; trimethoprim (BACTRIM). Concomitant medication included levothyroxine, tramadol, aluminium hydroxide gel, dried, magnesium carbonate (PEPCID). There was no other vaccine in four weeks. The patient had not COVID prior vaccination. The patient had not COVID tested post vaccination. The patient experienced pain at injection site, swelling, warmth, redness; all on 12Feb2021 08:00. The events resulted in physician office visit. The patient was hospitalized from Feb2021 for the events. Treatment received for the events included cefalexin (CEPHALEXIN) orally; methylprednisolone (MEDROL) dose pack; famotidine; and cetirizine hydrochloride (ZYRTEC). The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: LEVOTHYROXINE; TRAMADOL; PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]

Current Illness:

ID: 1070746
Sex: M
Age:
State: PA

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 03/03/2021
Hospital:

Lab Data: Test Name: blood work; Result Unstructured Data: Test Result:not significant for any abnormalities

Allergies:

Symptoms: Tingling burning in all extremities, trunk and face; Tingling burning in all extremities, trunk and face; weakness in all extremities; Shortness of breath with after completing one flight of stair.; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for himself. A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included high blood pressure (BP), ocular migraine. Concomitant medication included amitriptyline, amlodipine. The patient received first dose of BNT162B2 on 02Jan2021 4:00PM for Covid-19 immunization and expedited tingling in right 15 days first dosage. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Tingling burning in all extremities, trunk and face after second dosage. Tingling and burning was followed by weakness in all extremities including Shortness of breath with after completing one flight of stair. Visited primary care physician and blood work results were not significant for any abnormalities. Visited emergency room (ER) and was seen by neurologist who did think symptoms were severe. Awaiting EMG scheduled for 24Mar2021. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect drug administration to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: AMITRIPTYLINE; AMLODIPINE

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm