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: 1065085
Sex: M
Age:
State: CT

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 03/02/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Mild nausea; light headache; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, expiry date unknown), intramuscular at the left arm on 29Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced mild nausea and light headache on 30Jan2021 08:00. Events were non-serious. No treatment was received for the adverse events. Facility where the most recent COVID-19 vaccine administered was workplace clinic. The outcome of the events was recovering. Events were non-serious. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1065086
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: has been in contact with his family (wife and child) who tested positive for the coronavirus; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown dates (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient had been in contact with his family (wife and child) who tested positive for the coronavirus and would like to know if he should get his second dose of the Covid vaccine. The outcome of the event exposure to COVID-19 was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1065087
Sex: M
Age:
State: NY

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

Lab Data:

Allergies:

Symptoms: very sore arm at the injection site after both doses; Dr. told me that Aspirin was not stopped in the trials; This is a spontaneous report from a contactable physician, the patient. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown for first and second doses) solution for injection intramuscular on an unknown dates (at the age of 67-years-old) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medications included acetylsalicylic acid (ASPIRIN) low dose and ongoing atorvastatin. The patient got a very sore arm at the injection site after both doses but no other side effects. The patient took low dose aspirin and atorvastatin and was concerned that the reason for the lack of side effects was that the medications may have blunted the vaccine immune response. A doctor told the me (patient) that aspirin was not stopped in the trials. The outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN

Current Illness:

ID: 1065088
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: tired; This is a spontaneous report from a contactable healthcare professional, the patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown date (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced felt really tired. The outcome of the event felt really tired was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021145089 same drug/patient, second dose/different AE

Other Meds:

Current Illness:

ID: 1065089
Sex: F
Age:
State: TX

Vax Date: 01/08/2021
Onset Date:
Rec V Date: 03/02/2021
Hospital:

Lab Data:

Allergies:

Symptoms: arms a little sore; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. Medical history included blood pressure (abnormal). Concomitant medication included verapamil for blood pressure. It was reported that the patient got to receive the first one on the 8th. She did not have any symptoms than her arms a little sore. She got her second dose of Pfizer shot on the 28th and then she guessed the first. Outcome of the event was unknown. Information on lot/batch has been requested.

Other Meds: VERAPAMIL

Current Illness:

ID: 1065090
Sex: F
Age:
State: VA

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 03/02/2021
Hospital:

Lab Data:

Allergies:

Symptoms: she experienced a metallic taste; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiration date: May2021), via an unspecified route of administration on the left arm on 30Jan2021 09:00 at a single dose for Covid-19 immunization. The vaccine was administered at the hospital. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Jan2021 for Covid-19 immunization. On 30Jan2021 09:30, she experienced a metallic taste for about 30 minutes after the injection that lasted about an hour with outcome of recovered on 30Jan2021 10:30.

Other Meds:

Current Illness:

ID: 1065091
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: 2nd dose was more tired and itchy; 2nd dose was more tired and itchy; Hives; This is a spontaneous report from a contactable consumer (the patient) received from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on an unspecified date as a SINGLE DOSE for covid-19 vaccination. Historical data includes patient received Dose 1 (got tired and was itchy). The patient medical history and concomitant medications were not reported. On an unspecified date , The patient experienced 2nd dose was more tired and itchy and had hives. Consumer wants to know if she should go the Emergency Room 'waited 3 min and cold transferred to D&S Pfizer CEP 2191'. The clinical outcome of the events fatigue, itchy and hives was unknown. Information about Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1065092
Sex: U
Age:
State: SC

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

Lab Data:

Allergies:

Symptoms: Injection site pain; arm pain; headache; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the second dose of BNT162B2 (UNSPECIFIED TRADE NAME; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On unspecified dates the patient experienced injection site pain, arm pain and headache. The clinical outcomes of injection site pain, arm pain and headache were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1065093
Sex: F
Age:
State: CA

Vax Date: 01/12/2021
Onset Date: 01/16/2021
Rec V Date: 03/02/2021
Hospital:

Lab Data:

Allergies:

Symptoms: COVID-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 12Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the Pfizer COVID-19 vaccine on 12Jan2021 (reported as 21 days ago). Tomorrow (02Feb2021) is her second shot. On 16Jan2021 (16 days before the reporting), the patient got COVID-19. The patient was inquiring for the timeline of second dosage. The outcome of the event was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Other Meds:

Current Illness:

ID: 1065094
Sex: M
Age:
State: MA

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

Lab Data:

Allergies:

Symptoms: fatigue; arm soreness; This is a spontaneous report received from a contactable consumer (patient). A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247, expiry date was unknown), via an unspecified route of administration on right arm on 03Feb2021 11:30 AM at single dose for COVID-19 immunization, at workplace clinic. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 03Feb2021, 18:00, the patient experienced fatigue, arm soreness. Patient was not given treatment for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1065095
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (husband) reported for a female patient (wife) with unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 at 1:30pm at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced headache from unspecified date, and the consumer was asking if patient can take Excedrin for pain killer. The outcome of event was unknown. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1065096
Sex: F
Age:
State: MI

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 03/02/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Chill; Body aches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL8982), via an unspecified route of administration, on 21Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was inquiring if she can take paracetamol (TYLENOL) after the first COVID-19 vaccine because she was having body aches after the first injection on 21Jan2021. As of 03Feb2021, the patient was due for her second done on 11Feb2021. The patient had been hearing a myth that she wanted to know if it is true. After the patient's first shot she only had a small side effect which was the body aches. The patient got these about 12 hours after the shot, it happened through the night while she was sleeping. The following morning (22Jan2021), the patient also had what might have been a slight chill but just a slight one, but it was the body aches mostly. The patient took paracetamol (TYLENOL) extended release for the events. Then the patient was told that she shouldn't have taken the paracetamol and that people weren't supposed to take anything after getting the vaccine. The patient asked confirmation if this can't be true and asked what a person would take if they had a fever. The patient confirmed that she did not have a fever. The events subsided immediately, and it was like she never had them; they didn't last long at all. The patient recovered from the events in Jan2021.

Other Meds:

Current Illness:

ID: 1065097
Sex: M
Age:
State: CA

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

Lab Data: Test Name: IMG; Result Unstructured Data: Test Result:extremely low; Comments: he stated his IMG was extremely low; Test Name: surge test; Result Unstructured Data: Test Result:negative; Comments: report came back negative

Allergies:

Symptoms: got the 2nd Covid dose on 12Jan2021 and he stated his IMG was extremely low; This is a spontaneous report from a Pfizer Sponsored Program. A contactable other healthcare professional (patient) reported that a male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 12Jan2021, at a single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) on an unspecified date, for COVID-19 immunisation. On an unspecified date, the patient's immunoglobulins (IMG) were extremely low. He then took a surge test and the report came back negative. He was surprised by this and wanted to know if that is normal. Outcome of the event was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1065098
Sex: F
Age:
State: NY

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 03/02/2021
Hospital:

Lab Data: Test Date: 20210129; Test Name: COVID-19 (nasal swab); Test Result: Negative ; Test Date: 20210129; Test Name: PCR (nasal swab); Test Result: Negative

Allergies:

Symptoms: Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; edge is now scaly and dry; edge is now scaly and dry; This is a spontaneous report from a contactable Other Health Professional (patient). A 36-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) on 21Jan2021 (Lot number: El3249) via an unspecified route of administration in the right arm at single doe for COVID-19 immunization. The patient had no medical condition. The patient had no allergies to medications, food, or other products. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Dec2020 08:00 AM (Lot number: EJ1685) via an unspecified route of administration in the left arm for COVID-19 immunization and at 31Dec2020 12:00 PM experienced small rash on left side of chest. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient concomitant medication included Levothyroxine sodium (Euthyrox, Strength: 150ug) and Drospirenone/ethinylestradiol (Nikki, Strength: 3mg/0.02mg). After first shot developed small rash on left side of chest. Persisted for three weeks and was starting to fade when she got second dose. Grew 4-5 times larger, raised, painful, red itched and tender. Now reaches my neck and breasts and shoulders. White normal skin in center, edge was now scaly and dry, itches very badly. Dr won't prescribe steroid fears it will dampen immune response. Taking Allegra, Benadryl and hydrocortisone cream. Does not help. Never had a reaction to a vaccine before. The patient was underwent COVID-19 (Nasal Swab) and PCR at pharmacy (nasal swab) test (test twice weekly for work) both on 29Jan2021 which were negative. The events were assessed as non-serious by the reporter. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: EUTHYROX; NIKKI

Current Illness:

ID: 1065099
Sex: F
Age:
State:

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

Lab Data: Test Date: 20210202; Test Name: COVID-19 test; Test Result: Positive

Allergies:

Symptoms: tested positive for the Covid virus on 2ndFeb; tested positive for the Covid virus on 2ndFeb; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 3 patients. This is 1st of 3 reports. A 62-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Pharmacy technician, calling on behalf of three patients who tested positive after receiving the first dose of the Covid vaccine, asked when they can get the second dose of the Covid vaccine. They received their first dose on 16Jan2021 and tested positive for the Covid virus on 02Feb2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021140772 same drug/event, different patients;US-PFIZER INC-2021140773 same drug/event, different patients

Other Meds:

Current Illness:

ID: 1065100
Sex: F
Age:
State:

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 03/02/2021
Hospital:

Lab Data: Test Name: COVID-19; Test Result: Positive

Allergies:

Symptoms: feeling really bad; pain; tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose,via an unspecified route of administration on 28Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She started "feeling really bad, having pain, and felt like something ran over her" after the vaccine was given. She went to her MD and tested positive for Covid-19. She asks, "Can I take the second dose on 24Feb2021?'The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive. Outcome of event was unknown. Case was assessed as non-serious (Serious: No). Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1065101
Sex: M
Age:
State: LA

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 03/02/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache; Nausea; Eyes are bloodshot red and kind of glaze over; Eyes are bloodshot red and kind of glaze over; He just can't feel real good; This is a spontaneous report from a contactable consumer. A 96-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Jan2021 as a SINGLE DOSE for COVID-19 vaccination. Medical history included heart problems from an unknown date and unknown if ongoing, he has gone over for a battery replacement, pacemaker, and he has eye problems so, he is taking eye drops for those. Concomitant medications included unspecified eye drops. On unspecified date, the patient experienced headache, nausea and his eyes are bloodshot red and kind of glaze over. He just can't feel real good. His eyes are real red and like glaze over. No treatment was received for the events. Outcome of the events headache, nausea, eyes are bloodshot red and kind of glaze over and he just can't feel real good were unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1065102
Sex: M
Age:
State: WI

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

Lab Data:

Allergies:

Symptoms: Facial swelling; I have got Vitallium Partial, there was a pinching, it was very uncomfortable; Gum swelling; This is a spontaneous report from a contactable consumer (patient). This 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number E79262) via an unspecified route on an unspecified date (at the age of 85-years-old) as a single dose in the right upper arm for COVID-19 immunization. Medical history included unspecified health issues. Concomitant medications included unspecified regular medications he took several in the morning and at night. The patient also took vitamins "and different things like that" from unspecified dates for unspecified indications. The patient experienced facial swelling and gum swelling on an unspecified date. The patient had a Vitallium partial. The metal and the partial denture were pinching him; it was very uncomfortable. The patient stated it was not a life or death situation but he was ready to go to the dentist for an adjustment in the partials so it didn't hurt. The patient did not undergo any lab tests. The patient did not receive treatment for the events. The outcome of facial swelling and gum swelling was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: VITAMINS NOS

Current Illness:

ID: 1065103
Sex: F
Age:
State: NY

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

Lab Data:

Allergies:

Symptoms: mild fever; body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on an unknown date (at the age of 24-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included anxiety and depression. Concomitant medication included escitalopram oxalate (LEXAPRO). Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination in Jan2021 and experienced body chills. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date, the patient experienced mild fever and body aches. The outcome of the events mild fever and body aches was unknown. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021144818 same reporter/patient/vaccine, different dose/event

Other Meds: LEXAPRO

Current Illness:

ID: 1065104
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: pain in her arm; This is a spontaneous report from a contactable healthcare professional, the patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on an unknown date (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on an unknown date and experienced she felt really tired. On an unknown date, the patient experienced pain in her arm. The outcome of the event pain in her arm was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093322 same drug/patient, different dose/AE

Other Meds:

Current Illness:

ID: 1065105
Sex: M
Age:
State: MO

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

Lab Data:

Allergies:

Symptoms: Allergies; Sinus problems; Dizziness when he is up and moving around; Equilibrium is off; Fatigued; This is a spontaneous report from a contactable consumer (patient who is a transit operator). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5318), via an unspecified route of administration in right arm, on 25Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included ongoing urinary incontinence (use of medication that does not make him run to the bathroom and helps him hold his urine), ongoing acne, drowsy, and ongoing flow of urine or weak bladder. The patient's concomitant medications included fesoterodine fumarate (TOVIAZ; Expiration Date: 04Dec2021) (about 2 weeks prior to getting the COVID-19 vaccine) for urinary incontinence, doxycycline (Expiration Date: 26Nov2021; makes him drowsy) for acne, and tamsulosin (Expiration Date: 12Nov2021) for flow of urine or weak bladder; all from Jan2021 and ongoing. The patient does not take any of these medications while driving. The patient took his first Pfizer COVID-19 shot on 25Jan2021 (Monday). The patient had been experiencing dizziness which started a few days after getting the vaccine (Jan2021). The patient was supposed to work from Tuesday to Friday, but he did not go into work on Wednesday. The patient was unsure of the specific day the dizziness started. The patient did have allergies (unspecified date), but when he called in his doctor, he sent him a medication for allergies, meclizine (Expiration Date: 28Jan2022). Normally, the medication takes a couple days to make him feel better. After he took meclizine for dizziness, he feels better. The patient notices the dizziness when he is up and moving around. The patient can tell something is off, like his equilibrium is off in Jan2021. It may not be due to the shot, but looking at the paper it says tiredness, which he has been feeling fatigued (also started a few days after the vaccine, but he is unsure specifically what day) and dizziness, which he has in Jan2021. The medication he is taking (meclizine), can also do the same thing, but never for this long. When he takes it, it normally makes him feel better after a few days. The patient has sinus problems as well on an unspecified date, but never lasting this long. The patient had not started feeling better since taking the medication, meclizine (as reported). The patient also said that meclizine could be causing the fatigue because it does make his drowsy and he just sleeps when he takes it - he cannot take it when he drives. The patient would go back for the second dose on 15Feb2021. The patient was recovering from "Dizziness when he is up and moving around". The outcome of "Allergies" was unknown. The patient had not recovered from the remaining events.

Other Meds: TOVIAZ; DOXYCYCLINE; TAMSULOSIN

Current Illness: Acne; Bladder disorder; Urinary incontinence (Use of medication that does not make him run to the bathroom and helps him hold his urine)

ID: 1065106
Sex: M
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: headache; mild intermittent fatigue; This is a spontaneous report from a non-contactable consumer (patient himself). A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201), intramuscularly in left arm on 07Feb2021 11:30 AM at single dose for COVID-19 immunization in facility type other. The patient's medical history included heart disease, type 2 diabetes mellitus, throat cancer. The patient did not have allergies to medications, food, or other products. Concomitant medications included atorvastatin calcium (LIPITOR) at 40 mg daily, clopidogrel bisulfate (PLAVIX) at 75 mg daily, metformin at 500 mg daily, lisinopril at 5 mg daily, ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, lycopene, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium molybdate, sodium selenate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc oxide (CENTRUM FORTE) at 1 DF (Dosage Form) daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 07Feb2021 13:00, the patient experienced headache post dose x 1-2 hours (resolved after taking a short nap) and mild intermittent fatigue post dose x 4 days (recovering). The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the event headache was resolved on 07Feb2021 and recovering for the other event. No follow-up attempts are possible. No further information is expected.

Other Meds: LIPITOR; PLAVIX; METFORMIN; LISINOPRIL; CENTRUM FORTE

Current Illness:

ID: 1065107
Sex: F
Age:
State: NY

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

Lab Data: Test Date: 20210202; Test Name: Blood pressure; Result Unstructured Data: Test Result:Feels really high; Test Name: COVID-19 virus antibody; Result Unstructured Data: Test Result:8; Test Date: 20210111; Test Name: COVID-19 virus antibody; Result Unstructured Data: Test Result:1.9; Comments: Progressively going down

Allergies:

Symptoms: Blood pressure feels really high; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 16Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 virus in the past year (2020) from which her husband died last year (2020), receiving occupation therapy (OT) at home, and stroke (in the past). The patient's concomitant medications were not reported. The patient received her first Pfizer COVID-19 vaccine dose on 16Jan2021 and is scheduled to receive her next COVID-19 vaccine booster on 06Feb2021. The last time the patient had her COVID-19 virus antibody blood work was on 11Jan2021, and her COVID-19 virus antibodies were down to 1.9 from 8 (on an unspecified date). The patient's COVID-19 virus antibodies have been progressively going down since she was first being tested for them. The patient received a call today that her occupational therapist tested positive for the COVID-19 virus. Both her occupational therapist and she were wearing masks when working together. The patient received the call today because she was exposed to the occupational therapist. The patient asked if she can still take the COVID-19 vaccine booster that she is scheduled for on Saturday (06Feb2021). The patient really wanted to get the COVID-19 vaccine booster on 06Feb2021. The patient was going to be speaking with a trained healthcare professional when she is transferred to Pfizer medical information. Anyone the patient has spoken to about getting her second COVID-19 vaccine has not been willing to answer her questions. The patient's blood pressure feels really high now (02Feb2021), and she has had a stroke in the past. The outcome of the event was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Other Meds:

Current Illness:

ID: 1065108
Sex: F
Age:
State: FL

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

Lab Data:

Allergies:

Symptoms: Arm is slightly stiff; Muscle is slightly sore; Sore arms; just little tender; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 01Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included medroxyprogesterone and estradiol. The patient previously took the first dose of BNT162B2 in Jan2021 for COVID-19 immunization (got the first shot exactly 3 weeks before for which the patient was not sure of the date). On 01Feb2021, just shortly after the patient and his husband both got the shot, the patient had sore arms by the time they drove home yesterday afternoon. The patient's sore arm was much better today but it was still just little tender - that is the only thing she had. Currently (02Feb2021), the patient's arm was slightly stiff still, just the muscle is slightly sore. No treatment was taken for the adverse events. The patient was recovering from "Sore arms; just little tender". The outcome of the other events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Other Meds: MEDROXYPROGESTERONE; ESTRADIOL

Current Illness:

ID: 1065109
Sex: M
Age:
State: NJ

Vax Date: 02/08/2021
Onset Date: 02/01/2021
Rec V Date: 03/02/2021
Hospital:

Lab Data: Test Name: fever; Result Unstructured Data: Test Result:little high; Comments: using the strips on his forehead

Allergies:

Symptoms: shivering/having in and out chills; slight fever; fever, headache, dry heaves, fatigue, and crazy dreams; Adding strange dreams/crazy dreams/ so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up; hands were cold; headache fades in and out; Dry heaves; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EM5318, via an unspecified route of administration in the right arm on 08Feb2021 at 11:45 (at the age of 78-years-old) as a SINGLE DOSE for Covid-19 Vaccination. Historical vaccine includes BNT162B2 Dose 1, Lot Number 'He thinks its EL3302'. The patient had no known medical history or allergies. Concomitant medication included metoprolol tartrate (METOPROLOL TARTRATE), lisinopril (LISINOPRIL), atorvastatin (LIPITOR [ATORVASTATIN]). 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. Late on Wednesday 10Feb2021 The patient experienced his hands were cold, he went to bed and he was shivering, he had to put on clothes and 3 quilts and in the meantime he was having in and out chills and slight fever, fatigue and crazy dreams/so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up/three types all repeating four or more times and on Feb2021 experienced headache fades in and out and dry heaves. The patient underwent lab tests and procedures which included pyrexia: little high (using the strips on his forehead) on an unspecified date. As a result of the event abnormal dreams patient did visit a professional office/clinic visit. No treatment was given for the event. The clinical outcome of the event shivering/having in and out chills, slight fever, dry heaves, fatigue, headache and hands were cold were unknown while abnormal dreams was recovered Feb2021.

Other Meds: METOPROLOL TARTRATE; LISINOPRIL; LIPITOR [ATORVASTATIN]

Current Illness:

Date Died:

ID: 1065111
Sex: M
Age:
State: FL

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 03/02/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Very sick, then hospitalized Died; This is a spontaneous report from a contactable Other Health Professional (patient). A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 28Jan2021 06:00 at single dose for COVID-19 immunization. Medical history included Esrd controlled a-fib. Concomitant medication in two weeks included diphenhydramine hydrochloride (BENADRYL) before vaccine and some dialysis Ned maybe. Facility type vaccine: Other. If other vaccine in four weeks: No. If covid prior vaccination: No. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced very sick on 29Jan2021. The patient was not recovered from the event very sick. Event reported as Very sick and my father died. AE resulted in: Emergency room/department or urgent care, Hospitalization. AE treatment: Famotidine and nausea meds then hospitalized Died. It was unknown if an autopsy was done. Information on batch/lot number has been requested.; Sender's Comments: The limited information provided precludes a full clinical assessment of the case. Significant in the assessment would be the date when the first dose of the vaccine was given, the patient's complete medical history, and the full clinical course of the event (including specific symptoms/events associated with reported 'very sick'), which were unknown at the time of this report. This 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.; Reported Cause(s) of Death: Very sick, then hospitalized Died

Other Meds: BENADRYL

Current Illness:

ID: 1065113
Sex: F
Age:
State: CO

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

Lab Data: Test Date: 20210128; Test Name: Blood test; Result Unstructured Data: Test Result:Did not find anyting; Test Date: 20210128; Test Name: MRI; Result Unstructured Data: Test Result:Did not find anyting; Test Date: 20210128; Test Name: COVID 19; Result Unstructured Data: Test Result:Negative

Allergies:

Symptoms: barely able to stand; swollen lymph nodes; irregular heartbeat; severe upper back and neck pain; severe upper back and neck pain; She has barely been able to move for several weeks; dizzy; vertigo; headache; This is a spontaneous report from a contactable consumer, the patient's parent. A 20-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 25Jan2021 at 10:30 AM (at the age of 20-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to eggs. Historical vaccination included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 04Jan2021 at 10:30 AM (at the age of 20-years-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The vaccine was administered in a hospital. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The reporter explained that the patient's adverse events "started as expected" with a headache side effect (date not specified), however two days after the vaccine, while working as an EMT the patient became very dizzy and had to stop work. She remained dizzy, like vertigo, the next day but attempted to go to work. Her co-worker could see she wasn't right and took her to the hospital. The patient spent two days in the hospital, barely able to stand, getting a head MRI with contrast, evaluated for vertigo, blood tests, and they did not find anything and gave her vertigo medicine and sent her home. She has since had shifting symptoms, swollen lymph nodes, irregular heartbeat, severe upper back and neck pain. She has barely been able to move for several weeks and has seen an ENT doctor, another emergency doctor, and her regular doctor. None have found any other cause and have tried treating her with steroids. The events were treated with Meklazine and unspecified steroids. Lab data included SARS-CoV-2 test COVID 19 testing on 28Jan2021 which was negative. The clinical outcomes of headache, dizziness, vertigo, difficulty standing, swollen glands, irregular heart rate, back pain, neck pain and unable to more for several weeks were reported as not recovered. The patient was tested for COIVD-19 after the vaccination, on 28Jan2021, and was found to be negative.

Other Meds:

Current Illness:

ID: 1065114
Sex: F
Age:
State: GA

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 03/02/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Lost consciousness for brief period; bleeding from small gash in head; broke my finger; feeling out of sorts; feeling light headed; This is a spontaneous report from a contactable consumer (patient) who reported that a 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number:EL3246), via an unspecified route of administration into the right arm on 10Feb2021 07:45 at a single dose for COVID-19 immunisation. Medical history included known allergies to CT dye, COVID-19 from an unknown date prior to vaccination and known allergies to sulfa drugs. Patient was not pregnant. Patient had unspecified concomitant medications. On 11Feb2021 08:00, patient woke up feeling out of sorts and feeling light headed, patient sat down and the next thing she knew she was on the floor bleeding from a small gash in her head, she lost consciousness for a brief period and also broke her finger. The events required emergency room and physician office visit. The patient had 3 staples in her head and a finger splint for the events "bleeding from a small gash in her head" and "broke her finger". Outcome of events was recovering.

Other Meds:

Current Illness:

ID: 1065115
Sex: F
Age:
State: AL

Vax Date: 02/09/2021
Onset Date: 02/01/2021
Rec V Date: 03/02/2021
Hospital:

Lab Data: Test Date: 20210209; Test Name: fever; Result Unstructured Data: Test Result:103; Test Date: 20210210; Test Name: fever; Result Unstructured Data: Test Result:101; Test Date: 20210210; Test Name: fever; Result Unstructured Data: Test Result:102; Test Date: 20210211; Test Name: fever; Result Unstructured Data: Test Result:normal

Allergies:

Symptoms: racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break; joints and bones felt like they were going to break; no appetite; weakness, unable to get up out of bed; unable to get up out of bed; patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); tired; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL3302 and expiry date unknown, via unspecified route of administration on 09Feb2021 at single dose for Covid-19 immunization in a workplace clinic. Medical history included sjogrens disease/syndrome (immune disease), sulfa allergies. The patient's concomitant medications included several medications daily. The patient previously took morphine and experienced allergies and made her sick. Historical vaccine included first dose of BNT162B2, lot number EJ 1686 on 15Jan2021 for Covid-19 immunization. The patient has no Covid prior vaccination. On 09Feb2021 11:00 am (also reported as started 12 hours after 2nd shot), she experienced fever 103, hard chills, racing heart, headache, joints and bones felt like they were going to break, no appetite, weakness, unable to get up out of bed. The patient informed that the hardest time and highest fever was 11 PM to 6 AM Tue/Wed. The chills were severe, felt like her spine would snap into. The patient was still sick Wed (10Feb2021), the fever was not as high 101 to 102. The patient informed that what was scary was heart racing for hours that first night. The patient thought she was going to die. The patient informed that she didn't have heart problems, but she has Sjogrens, an immune disease. The patient informed that the fever was finally back to normal on Thursday (11Feb2021) afternoon after getting shot Tuesday noon. The patient informed that it's Sunday (14Feb2021) and she was still tired and has headache. The patient informed that it has to be something to do with Sjogrens. The patient informed that her rheumatologist said nobody so far had the kind of fever/reactions she had. The patient has not Covid tested post vaccination. The patient has explicit consent. The patient did not received treatment due to the events. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "racing heart" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1065116
Sex: F
Age:
State: CA

Vax Date: 01/21/2021
Onset Date: 02/11/2021
Rec V Date: 03/02/2021
Hospital:

Lab Data: Test Date: 20210213; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: pneumonia; Fever; chills; nausea; difficulty breathing; This is a spontaneous report from a contactable other HCP (patient). A 33-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 11:00 at a single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient experienced fever, chills, nausea, pneumonia, and difficulty breathing on 11Feb2021 23:00 with outcome of recovering. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was not diagnosed of covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab test post vaccination: negative on 13Feb2021. Therapeutic measures were taken as a result of events (antibiotics, IV fluids, Tylenol). The patient received second dose (Lot Number: EN6201) on 12Feb2021 12:00 PM in the left arm.; Sender's Comments: There is a reasonable possibility that the events fever, chills, and nausea were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the events pneumonia and difficulty breathing with Bnt162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1065117
Sex: F
Age:
State: MN

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

Lab Data:

Allergies:

Symptoms: Gastrointestinal bleeding; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program COVAX US Support reported reporter's sister. A female patient of an unspecified age (reported as 77) 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. The patient's medical history and concomitant medications were not reported. The patient experienced gastrointestinal bleeding on 04Feb2021 with outcome of recovering. The patient was hospitalized for gastrointestinal bleeding from 04Feb2021 to 09Feb2021. The patient received the 1st dose of the vaccine and is due for the 2nd dose on 18Feb2021. The patient was admitted in the hospital on 04Feb2021 for Gastrointestinal bleeding, was discharged on 09Feb2021 but was back in the ER on 10Feb2021. The patient was nearing recovery. The reporter denied that this was a side effect of the vaccine. The reporter was asking if it would be okay for her sister to take the 2nd dose as scheduled. Information on the lot/ batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. There is no evidence or argument to suggest a causal relationship between the suspect vaccine BNT162B2 and the event gastrointestinal bleeding. The event is likely due to an underlying medical condition.

Other Meds:

Current Illness:

ID: 1065118
Sex: F
Age:
State: WA

Vax Date: 01/23/2021
Onset Date: 01/30/2021
Rec V Date: 03/02/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Blood clot in lower left leg; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on the left arm, at age 58 years, first dose on 23Jan2021 14:00 at single dose for COVID-19 vaccination. Medical history was reported as none. Patient had no known allergies. The patient is not pregnant. There were no concomitant medications. There were no other vaccines administered in four weeks and no other medications taken in two weeks. On 30Jan2021, patient experienced blood clot in lower left leg. ER doc indicated that patient had no reason to have formed a clot given the medical history, health, weight, age, diet, no surgeries, no prior injury, etc. Facility type vaccine was administered at a Public Health Clinic/Veterans Administration facility. Event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event includes rivaroxaban (XARELTO) as blood thinner. The outcome of the event was not recovered. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1065119
Sex: F
Age:
State: MA

Vax Date: 02/06/2021
Onset Date: 02/08/2021
Rec V Date: 03/02/2021
Hospital: Y

Lab Data: Test Date: 20210209; Test Name: CT Scan; Result Unstructured Data: Test Result:appendicitis; Test Date: 20210209; Test Name: Covid test type post vaccination Nasal Swab; Test Result: Negative ; Comments: Covid test type post vaccination Nasal Swab

Allergies:

Symptoms: appendicitis; intense abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 06Feb2021 15:45 (03:45 PM) at a single dose as Covid vaccine. Medical history included gastrointestinal distress at the time of incident. The patient had no known allergies. Concomitant medications included cyanocobalamin (B12), calcium, levothyroxine sodium (LEVOXYL), lisinopril, and ergocalciferol (VIT D). The patient developed intense abdominal pain on 08Feb2021 10:00 AM. She went to the ER on 09Feb2021 and a CT scan on 09Feb2021 which revealed that she had appendicitis on 08Feb2021 10:00 AM. The patient was hospitalized for the events from 09Feb2021 to 13Feb2021 (4 days of hospitalization). Treatment for the events included intravenous antibiotics. The patient had no Covid prior to vaccination. Additional lab data included Covid test type post vaccination Nasal Swab with negative result on 09Feb2021 (Covid tested post vaccination). The outcome of the events was recovering. Information on the lot/batch number has been requested.

Other Meds: B12 [CYANOCOBALAMIN]; CALCIUM; LEVOXYL; LISINOPRIL; VIT D

Current Illness:

ID: 1065120
Sex: F
Age:
State: AZ

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

Lab Data:

Allergies:

Symptoms: almost blacked out; Dizzy; sweating; turned very pale; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: LE9267, expiration date unknown) via an unspecified route of administration in the left arm on 13Feb2021, 09:45AM (at 50 years old) at a single dose for COVID-19 immunization. The patient was not pregnant when vaccinated in Other Vaccination Facility Type. Medical history included high blood pressure and allergies to Biaxin and Amoxicillin; all from an unknown date and unknown if ongoing. Concomitant medications included calcium, lisinopril, colecalciferol (VITAMIN D) which were received within 2 weeks of vaccination. At 50 years old, the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL1283, expiration date unknown) via an unspecified route of administration in the left arm on 23Jan2021, 09:00AM at a single dose for COVID-19 immunization. The patient was not diagnosed with COVID prior to vaccination, did not receive any other vaccines within 4 weeks prior to BNT162B2, and was not tested for COVID post vaccination. On 14Feb2021 09:45, the patient experienced dizzy, sweating, turned very pale, and almost blacked out. No therapeutic measures were taken as a result of the adverse events. The patient recovered from the events on an unspecified date.

Other Meds: CALCIUM; LISINOPRIL; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1065121
Sex: F
Age:
State: FL

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

Lab Data:

Allergies:

Symptoms: petechiae on the skin; conjunctival hemorrhage; This is a spontaneous report from a contactable Consumer reporting for her mother in law. A 72-years-old female patient received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 12Feb2021 at single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 vaccine on an unknown date. The patient experienced conjunctival hemorrhage on 13Feb2021 with outcome of unknown , petechiae on the skin on 14Feb2021 described as round, red spots on the arm, leg, and belly with no more than 6 spots, with outcome of unknown. Conjunctival hemorrhage was considered an Important Medical Event. Information about Lot number has been requested.

Other Meds:

Current Illness:

ID: 1065122
Sex: M
Age:
State: CA

Vax Date: 02/01/2021
Onset Date: 02/05/2021
Rec V Date: 03/02/2021
Hospital:

Lab Data:

Allergies:

Symptoms: unable to stand or walk; Legs no longer able provide support; mentally increased disorientation at times; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262) on 01Feb2021 at 15:00 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 05Feb2021 4 days after vaccine, patient was unable to stand or walk with rolling walker. Prior to vaccine, patient was able to ambulate slowly with rolling walker. Legs no longer able provide support. Also mentally increased disorientation at times. Patient visited doctor office due to the events considered as disabling. At the time of the reporting the patient had not yet recovered from the events.

Other Meds:

Current Illness:

ID: 1065123
Sex: F
Age:
State: GA

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

Lab Data: Test Date: 20210214; Test Name: fever; Result Unstructured Data: Test Result:102 degree fever

Allergies:

Symptoms: gets 102 degree fever; Could not speak much next two days; Within one hour or so after: found on floor, fell on right side; unable to speak like a TIA; disoriented; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021 at 13:00 at single dose for COVID-19 immunisation at the age of 82-year-old. Medical history included dementia, high blood pressure, allergy to drugs with sulfer. Concomitant medications included 2.5 Amlodipine, 81 mg aspirin, 0.5 clonazepam, 20 mg Escitalopram, 10 mg melatonin, 5 mg memantine, 15 mg mirtazapine. The patient was not pregnant. The patient received first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 at single dose for COVID-19 immunisation at the age of 82-year-old. Within one hour or so after the vaccine administration: the patient was found on floor, fell on right side, disoriented, unable to speak like a transient ischemic attack (TIA), out of it. The patient could not speak much next two days. Don 14Feb21 at 15:00, the patient got 102-degree fever. The patient was treated for the events. The patient was recovering from the events. Information on the lot/ batch number has been requested.

Other Meds: AMLODIPINE; ASPIRIN [ACETYLSALICYLIC ACID]; CLONAZEPAM; ESCITALOPRAM; MELATONINE; MEMANTINE; MIRTAZAPINE

Current Illness:

ID: 1065124
Sex: M
Age:
State: NC

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

Lab Data:

Allergies:

Symptoms: Chills; Headache; extremely weak; has not felt like eating anything; This is a spontaneous report from a contactable nurse reporting for her husband. A 76-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL9264), via an unspecified route of administration in the deltoid right, on 03Feb2021 at 15:00, at single dose, for COVID-19 immunisation. Medical history included cardiac disorder from 2007 and ongoing, cholecystectomy on 21Dec2020, stent placement from Dec2020 to Jan2021 (stents placed on 27Dec2020 or 28Dec2020, in Jan2021 it was removed), hospitalisation from Dec2020 to Jan2021 (for 11 days), ongoing weakness (weakened state). The reporter explained that her husband had some big issues from Nov2020 to Jan2021 which ended in the removal of a dead gallbladder that was gangrene and had to have stents placed. He was in a weakened state already. There were no concomitant medications. No other vaccines were administered on the same date or 4 weeks prior. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1283) on 13Jan2021, for COVID-19 immunisation, with no adverse effect. The patient experienced chills on 08Feb2021 with outcome of not recovered, headache on 08Feb2021 with outcome of not recovered, extremely weak on 08Feb2021 with outcome of not recovered, has not felt like eating anything in Feb2021 with outcome of not recovered. The events chills, headache and extremely weak were considered medically significant. Therapeutic measures were taken as a result of chills and included treatment with Tylenol. The reporter assessed the events as related to vaccination.

Other Meds:

Current Illness: Heart disease, unspecified; Weakness (Weakened state)

ID: 1065125
Sex: F
Age:
State: NJ

Vax Date: 02/10/2021
Onset Date: 02/14/2021
Rec V Date: 03/02/2021
Hospital: Y

Lab Data: Test Name: Blood work; Result Unstructured Data: Test Result:Unknown result; Comments: blood work to check the enzymes in her blood for her cardiac muscle, but there was no reason, nothing they could find about why her heart rate spiked.; Test Name: EKG; Result Unstructured Data: Test Result:Unknown result; Comments: blood work to check the enzymes in her blood for her cardiac muscle, but there was no reason, nothing they could find about why her heart rate spiked.; Test Name: heart rate; Result Unstructured Data: Test Result:increased; Test Name: heart rate; Result Unstructured Data: Test Result:130; Test Name: heart rate; Result Unstructured Data: Test Result:109-125; Test Name: heart rate; Result Unstructured Data: Test Result:112-115; Test Name: COVID 19; Result Unstructured Data: Test Result:Unknown result; Comments: blood work to check the enzymes in her blood for her cardiac muscle, but there was no reason, nothing they could find about why her heart rate spiked.

Allergies:

Symptoms: heart rate jumped up; thought she was going to pass out; eyes were blurry; This is a spontaneous report from a contactable consumer. A 43-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264) on 10Feb2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included autoimmune issues diagnosed in 2006-2007. Concomitant medications were not reported. After 4 days from vaccination on 14Feb2021 the patient experienced blurred vision, increased heart rate, and feeling that she will pass out (as such) . She went to the Emergency Room and they did two EKGs, two COVID tests, and blood work to check the enzymes in her blood for her cardiac muscle, but there was no reason, nothing they could find about why her heart rate spiked. Patient also reported that her heart rate went up from about 03:00PM up thru midnight last night, and was still not down completely, it was a little erratic, but it was better than it was. She was prescribed treatment at the hospital to bring her heart rate down, but they didn't want to give her more and risk lowering her blood pressure. Patient was monitored through the night, and she was supposed to see a cardiologist there but they didn't show up, so she put a phone call in to hers. She was admitted to the hospital overnight. The patient recovered from the events on an unspecified date.

Other Meds:

Current Illness:

ID: 1065126
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: kidney infection; This is a spontaneous report from a contactable consumer or other non hcp. A 88-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 09Feb2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced kidney infection on an unspecified date. Patient started on sulfamethoxazole/trimethoprim. The outcome was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1065127
Sex: F
Age:
State: SC

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

Lab Data: Test Date: 202102; Test Name: Covid; Test Result: Positive

Allergies:

Symptoms: tested positive; tested positive/experienced more like a cold; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect from a contactable consumer (patient). A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had my first shot last month. Her 2nd shot on 12th Feb, daughter came with Covid tested positive, also her co-worker. 1st of Feb. She was also tested positive. She experienced more like a cold, She would like to know if she should take the 2nd shot.The patient underwent lab tests and procedures which included sars-cov-2 test: positive in Feb2021. Outcome of events was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1065128
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: cardiac events/cardiac issues; This is a spontaneous report from a contactable Nurse. A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 as a single dose for COVID-19 immunisation, lot number: unknown. Medical history and concomitant medications were not provided. It was reported that patient was hospitalized on unknown date due to cardiac events/ cardiac issues (onset date unknown). The nurse was caring for a patient who received the first (1 st) dose of the vaccine in the beginning of Jan2021, then wound up sick and in the hospital. The patient's second (2 nd) dose was due around the 20th or 21Jan2021, but the patient missed the dose due to being in the hospital. Nurse wanted to know if patient should she be getting the 2nd dose now or restarting the series. Nurse stated that the patient did not have an adverse event to the vaccine; she had unrelated cardiac issues. Outcome of the event was unknown. information about Lot/ Batch number requested.; Sender's Comments: The reported cardiac disorder was most likely an intercurrent/concurrent disease, and unrelated to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).

Other Meds:

Current Illness:

ID: 1065129
Sex: M
Age:
State: WA

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

Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:normal resting heart rate is upper 60s; Test Date: 20210212; Test Name: Heart rate; Result Unstructured Data: Test Result:113 BPM; Test Date: 20210212; Test Name: Heart rate; Result Unstructured Data: Test Result:92-94 BPM for 2 hours

Allergies:

Symptoms: tunnel vision; warm sensation travel from the left shoulder area to my chest/upper stomach; eyes burned; could taste something; heart rate became rapid at a steadily increase amount (113 bpm)/pulse stayed at 92-94 BPM for approximately two hours; felt dizzy; lost speed sensation in the car I was driving; This is a spontaneous report from a contactable consumer (patient himself). A 54-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6201), via an unknown route, on 12Feb2021 (at 12:45) at a single dose in the left arm for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included atrial fibrillation from Jun2020, ablation surgery for atrial fibrillation on unknown date, ongoing atrial tachycardia, and ongoing premature ventricular contractions (PVCs). Past drug history included allergy to penicillin. Relevant concomitant medications included vitamin NOS, mineral NOS (MEGA MEN) and amino acids NOS, carotenoids NOS, herbal NOS, hyaluronic acid, methylsulfonylmethane, minerals NOS, vitamins NOS (GNC MEGA MEN SPORT). Within approximately two minutes of receiving the shot, he felt a warm sensation travel from the left shoulder area to his chest/upper stomach, his eyes burned, he could taste something, and his heart rate became rapid at a steadily increase amount. He watched his heart rate tick up on her watch to approximately 113 BPM. His normal resting heart rate was upper 60s. He felt dizzy and out of it for about 30 minutes. He felt like he had tunnel vision and lost speed sensation in the car he was driving. His pulse stayed at 92-94 BPM for approximately two hours. He wasn't anxious about getting the shot and had actually been looking forward to it. The patient was not treated for the events. The patient had recovered from 'felt dizzy' on 12Feb2021 while the remaining events resolved in Feb2021.

Other Meds: MEGA MEN; GNC MEGA MEN SPORT

Current Illness: Atrial tachycardia; Premature ventricular contractions

ID: 1065130
Sex: M
Age:
State: NC

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

Lab Data: Test Date: 20210215; Test Name: Heart rate; Result Unstructured Data: Test Result:95; Comments: bpm; Test Date: 20210203; Test Name: PSA; Result Unstructured Data: Test Result:Unknown result

Allergies:

Symptoms: injection site swelling; heart rate increased (95 bpm); jumping heart rhythm; Weakness; coughing while trying to take a full breath; sore right arm; This is a spontaneous report from a contactable consumer reporting for himself. An 81-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EN6201), via an unspecified route of administration in the right arm, on 11Feb2021 at 11:45, at single dose, for COVID-19 immunisation. Medical history included ulcer haemorrhage, ongoing arthritis, blood pressure abnormal, coagulopathy, surgery (for his chronic arthritis in the neck and shoulder), cardiac disorder (with heart aneurysm and a murmur). Concomitant medications included indapamide (unknown manufacturer) for blood pressure abnormal, acetylsalicylic acid (ECOTRIN 81 MG) for anticoagulant therapy, potassium (unknown manufacturer), candesartan (unknown manufacturer) for blood pressure abnormal, clorazepate dipotassium (TRANXENE) for muscle relaxant therapy for his chronic arthritis in the neck and shoulder. The patient experienced jumping heart rhythm on 15Feb2021 with outcome of not recovered, weakness on 15Feb2021 with outcome of recovered, coughing while trying to take a full breath on 15Feb2021 with outcome of recovered, sore right arm on 11Feb2021 with outcome of recovering, injection site swelling on an unspecified date with outcome of unknown, heart rate increased (95 bpm) on 15Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included heart rate: 95 bpm on 15Feb2021, prostatic specific antigen (PSA): unknown result on 03Feb2021. Therapeutic measures were taken as a result of sore right arm and included treatment with Tylenol.

Other Meds: INDAPAMIDE; ECOTRIN 81 MG; POTASSIUM; CANDESARTAN; TRANXENE

Current Illness: Chronic arthritis

ID: 1065131
Sex: F
Age:
State: CA

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 03/02/2021
Hospital:

Lab Data: Test Date: 2008; Test Name: Liver Disease; Result Unstructured Data: Test Result:Liver Disease; Comments: diag.2008, 2017 exam fully functional; Test Date: 2017; Test Name: Liver Disease; Result Unstructured Data: Test Result:fully functional; Comments: diag.2008, 2017 exam fully functional

Allergies:

Symptoms: abdominal pain; mild muscle soreness at site; Fatigue; never feels rested or wants/needs to sleep; This is a spontaneous report from a contactable Consumer (patient). A 56-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 56-year-old) on 21Jan2021 as a single dose for COVID-19 immunisation, lot number: EL8982. Medical history included gall bladder, liver disease (diagnosed in 2008, 2017 exam fully functional), Umbilical (umb) hernia and ulcer. Patient had allergy-severe hives caused by plasma transfusion. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Other medications within two weeks prior to the vaccination was reported as not applicable (N/A). On 21Jan2021 patient received the first dose, following day (22Jan2021) mild muscle soreness at site, ongoing fatigue, never felt rested or wanted/needed to sleep, a lot. Noticed abdominal pain, did not connect the two. All events considered serious due to disability or permanent damage. No treatments received for the events. Prior to vaccination the patient was not diagnosed with COVID-19. Patient was not tested for Covid post vaccination. Since the vaccination patient had not been tested for COVID-19. Patient had not recovered from the event fatigue and recovered with sequel (recovered with lasting effects) from the other mentioned events.

Other Meds:

Current Illness:

ID: 1065132
Sex: F
Age:
State: OH

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 03/02/2021
Hospital:

Lab Data: Test Date: 20210211; Test Name: fever; Result Unstructured Data: Test Result:fever 101.9; Test Date: 20210211; Test Name: fever; Result Unstructured Data: Test Result:fever in the 101.1 to 101.9 range; Comments: Continued with fever in the 101.1 to 101.9 range for remainder if day.

Allergies:

Symptoms: sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints hurt; very large lymph node swelling on left (neck/collarbone/under arm).; cough; Spoke to MD regarding feet as it was difficult to walk; vaginal bleeding; headache; fever 101.9; felt like I was in shock; uncontrollable shaking; fast breathing; freezing; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 10Feb2021 at 11:00 AM (at the age of 46-year-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to sulfa drugs. The patient has pins in both feet from prior surgery. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ) on 19Jan2021 at 11:30 AM (at the age of 46-year-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient stated that it was unknown if prior to the vaccination, she had COVID-19. The vaccine was administered in a Nursing Home facility. Concomitant medications were not reported. The patient did not receive other vaccines within four weeks prior to the COVID vaccination. On 11Feb2021 the patient awoke at 1:30 AM with uncontrollable shaking, fast breathing, and she was freezing. She had no temperature at that time, almost felt like she was in shock. She took a shower and got calmed down. She was very nauseous but able to go back to sleep. At 04:30 AM she awoke again, this time with headache and a fever of 101.9. She continued with a fever in the 101.1 to 101.9 range for remainder of the day. The next day, 12Feb2021, she awoke feeling better and no fever but she had welts on her toes and her feet were swollen. Both feet and hand joints hurt and she had very large lymph node swelling on left (neck/collarbone/under arm). She also had developed a cough. She spoke to her MD regarding her feet as it was difficult to walk. They directed her to the Emergency Room (ER). The ER staff said to watch for two days. Later that evening (12Feb2021) she started having some shortness of breath and vaginal bleeding. She has an IUD and has not had a period for four years. She called the ER and they gave same advice. She had no fever that day (13Feb2021) but she woke around 3:30 AM soaked. As of 14Feb2021 she was still short of breath on/off and still has sore feet. The patient did not receive treatment for the events. Lab data included Fever of 101.9 on 11Feb2021 and fever in the 101.1 to 101.9 range also on 11Feb2021. The clinical outcome of shortness of breath was reported as not recovered. The clinical outcome of shock-like symptom, shaking, fast breathing, feeling cold, nauseous, headache, fever, welts, swelling of feet, arthralgia, lymphadenopathy, cough, gait disturbance, vaginal bleeding, hyperhidrosis was reported as recovering. The patient has not been tested for COIVD-19 after the vaccination. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1065133
Sex: F
Age:
State: IL

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

Lab Data:

Allergies:

Symptoms: Bell's Palsy; This is a spontaneous report from a contactable Consumer. This 66-year-old female consumer reported that received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot# not provided), via an unspecified route of administration on 12Feb2021 (at the age of 67-year-old) at 05:45 PM in the left arm at single dose for COVID-19 immunization. She had received the first dose of BNT162B2 on 22Jan2021, at 06:00 PM in the left arm. The patient had no history of allergies to medications, food, or other products. Medical history included Thyroid, Panic Disorder, Mild Depression. Concomitant medications included levothyroxine, simvastatin, trazodone, clonazepam. The patient reported that early in the day, on 12Feb2021, before receiving her second dose, she began to feel something odd going on with her mouth. She couldn't really identify it, but she felt like something wasn't quite the same. It was very mild, so she brushed it off. She had her second vaccine dose, on 12Feb2021 at 5 pm. By about 7 pm that night, she was rushed to the University Name Emergency room and was diagnosed with Bell's Palsy. She was treated with Prednisone 10MG X3, valACYclovir 1g X3, polyviny. At the time of reporting the patient had not recovered.

Other Meds: LEVOTHYROXINE; SIMVASTATIN; TRAZODONE; CLONAZEPAM

Current Illness:

ID: 1065134
Sex: M
Age:
State: ID

Vax Date: 02/12/2021
Onset Date: 02/14/2021
Rec V Date: 03/02/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting; Patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting; Patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting; Patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date unknown), via an unspecified route of administration on 12Feb2021 14:00 at single dose for COVID-19 immunization. The patient's medical history included diabetes mellitus and hypertension. The patient had no known drug allergies. The patient's concomitant medication included metformin. The patient previously took first dose of BNT162B2 on 23Jan2021 in the right arm at 07:00 PM. The patient had no COVID prior to vaccination and no COVID tested post vaccination. The patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting on 14Feb2021 23:30. Patient was taken by POV to emergency department where he received fluids and anti-emetic. The outcome of the events were recovered on an unspecified date. Information about lot/batch number has been requested.

Other Meds: METFORMIN

Current Illness:

ID: 1065135
Sex: F
Age:
State: MO

Vax Date: 01/23/2021
Onset Date: 02/11/2021
Rec V Date: 03/02/2021
Hospital: Y

Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: Vertigo and throwing up; Vertigo and throwing up; This is a spontaneous report from a contactable consumer reported for herself. A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot number: EK9231 on 23Jan2021 (at the 90-year-old), at single dose for COVID-19 immunization via unspecified route of administration at the left arm. Medical history included vertigo seven years ago and she had taken a Meclizine for it. The patient wore hearing aids On the day of first COVID-19 Vaccine she was perfectly healthy. She was very alert for a 90-year-old. The patient had received influenza vaccine on unknown date. On 11Feb2021 the patient experienced Vertigo and throwing up. The patient was hospitalized for the events from 11Feb2021 to 13Feb2021. The patient received Meclizine, but it wasn't helping. The patient was admitted for 3 days until she felt well enough. The hospital took a blood test with unknown result. The patient did a little bit of physical therapy and she was given mostly IV fluids because she was throwing up. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1065136
Sex: U
Age:
State: NY

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

Lab Data:

Allergies:

Symptoms: strokes; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is 1st of 2 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization in a hospital. The patient's medical history reported as none. Concomitant medications were not reported. The physician reported that there were two patients who came in with strokes with no underlying condition/health risks, but they had been recently vaccinated with the COVID vaccine on unspecified date. The event resulted in physician office visit. Outcome of the event was unknown. The event was assessed as serious (hospitalization). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the implied time association, the possible contribution of suspect vaccine BNT162B2 to the event stroke cannot be excluded. The patient's age and detailed clinical course would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021163468 same reporter, product, event; different patient

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm