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: 1037831
Sex: F
Age:
State: KY

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

Lab Data:

Allergies:

Symptoms: Allergic to the pneumonia vaccine; This is a spontaneous report from a Pfizer sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for Immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was Allergic to the pneumonia vaccine. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected

Other Meds:

Current Illness:

ID: 1037832
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program A male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included ongoing eczema. Concomitant medications were not reported. The patient previously took dupilumab (DUPIXENT) for eczema. The patient experienced flare up of eczema on an unspecified date. Clinical outcome the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness: Eczema

ID: 1037833
Sex: F
Age:
State:

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

Lab Data: Test Name: computerized tomography; Result Unstructured Data: Test Result:stage 1 lung cancer

Allergies:

Symptoms: stage 1 lung cancer; This is a spontaneous report from Pfizer sponsored program. A contactable consumer (patient herself) reported that a 59-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 12Feb2021 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She informed that 3 days after the shot, she had CT with contrast for stage 1 lung cancer. She was scheduled to receive the Pfizer-BioNTech COVID-19 Vaccine Dose 2 on 12Feb2021. The outcome of event was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1037834
Sex: F
Age:
State: NC

Vax Date: 01/21/2021
Onset Date: 01/23/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Bell's Palsy/right side of my face is completely paralyzed; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1283), via an unspecified route of administration on 21Jan2021 17:45 at single dose (left arm) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products and patient was not pregnant. On 23Jan2021, the patient experienced Bell's Palsy about 48 hours after receiving the vaccine. The right side of her face was completely paralyzed. The patient was treated with prednisone and valacyclovir. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of event was not recovered.

Other Meds:

Current Illness:

ID: 1037835
Sex: M
Age:
State:

Vax Date: 01/28/2021
Onset Date: 02/03/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: I practically passed out and couldn't stand up; I practically passed out and couldn't stand up; This is a spontaneous report from a contactable consumer (Patient). A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 at 10:45 at single dose for COVID-19 immunization. The patient medical history included ex-alcohol user (didn't drink anymore). Concomitant medications were not reported. The patient reported he practically passed out and couldn't stand up on 03Feb2021 at 15:15. Patient was pretty healthy and didn't drink anymore. Things like that used to happen when he drank but not now. He hoped it wasn't something neurologic going on with my body. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1037836
Sex: F
Age:
State: NJ

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Patient fainted; This is a spontaneous report from a contactable pharmacist. A 19-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982), intramuscular in the left arm on 04Feb2021 12:00 at single dose for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient medical history and concomitant medications were not reported. The patient fainted on 04Feb2021 12:00 with outcome of recovered in Feb2021. No treatment was performed due to the event. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between event syncope and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1037837
Sex: F
Age:
State: CA

Vax Date: 01/20/2021
Onset Date: 01/25/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 20210125; Test Name: ultrasound; Result Unstructured Data: Test Result:blood clots at right leg

Allergies:

Symptoms: ultrasound revealed blood clots at right leg; Swollen ankle and foot after 5-6 days of first dose; Swollen ankle and foot after 5-6 days of first dose; This is a spontaneous report from a contactable consumer reported for herself. A 73-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 20Jan2021 11:00 at single dose for COVID-19 immunisation. The patient was vaccinated in nursing home/senior living facility. Medical history included high blood pressure, monitored for lymph node growth. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included high blood pressure medication and clonazepam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen ankle and foot on 25Jan2021 12:00 AM after 5-6 days of first dose, ultrasound revealed blood clots at right leg. Doctor ordered to take apixaban (ELIQUIS) immediately during second week. The events resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered. Information on the lot/batch number has been requested.

Other Meds: CLONAZEPAM

Current Illness:

ID: 1037838
Sex: F
Age:
State: CA

Vax Date: 01/20/2021
Onset Date: 01/28/2021
Rec V Date: 02/18/2021
Hospital: Y

Lab Data: Test Date: 20210128; Test Name: COVID-19 Test; Test Result: Positive ; Comments: Nasal Swab

Allergies:

Symptoms: tested positive for COVID after the 1st dose of Pfizer.; This is a spontaneous report from a consumer or other non hcp. A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration left arm on 20Jan2021 09:45 at 0.3 mL, single dose, for COVID-19 immunisation. Medical history included obesity, hypertension. Concomitant drugs were not reported. No other vaccine was received in four weeks. The patient experienced tested positive for covid nasal swab test on 28Jan2021. The patient was hospitalized for 4 days. Patient was treated with oxygen. The outcome was recovering.

Other Meds:

Current Illness:

ID: 1037839
Sex: M
Age:
State: NJ

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

Lab Data: Test Date: 20210203; Test Name: covid test; Result Unstructured Data: Test Result:Unknown result

Allergies:

Symptoms: cough; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 57-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Jan2021 (at the age of 57-years old) as a SINGLE DOSE for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient was scheduled to get the second shot on 05Feb2021. Patient got COVID like symptoms, he had a cough and "all that stuff" starting about 3 days ago on unspecified date in 2021. He went to a pharmacy to get tested and waiting for results. He went to the hospital right after (pharmacy) and got admitted on 03Feb2021 and was still in hospital right now. His doctor suggested not to get the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on 03Feb2021. Outcome of the cough was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1037840
Sex: F
Age:
State:

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/18/2021
Hospital: Y

Lab Data: Test Date: 20210125; Test Name: BP; Result Unstructured Data: Test Result:High; Test Name: BP; Result Unstructured Data: Test Result:173/113; Test Name: CT scan; Result Unstructured Data: Test Result:ok; Test Name: Heart enzymes; Result Unstructured Data: Test Result:Normal

Allergies:

Symptoms: Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; headache; high bp/ had a BP 173/113; short of breath; couldn't sleep; restless; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Ten minutes after she reported having a headache, which she ignored. 2 hours later, very high blood pressure (BP), short of breath (SOB) and restless occurred. All night on 25Jan2021 and the next day on 26Jan2021, the patient couldn't sleep, short of breath, restless. The patient called PCP and was told to go to the ER. She did and had a BP 173/113, SOB. She was admitted, CT scan was ok. She had very bad rash blue red swollen on thigh. Heart enzymes was normal. She was discharged two days later referral to a dermatologist. The outcome of events was unknown. Information on the batch number has been requested.

Other Meds:

Current Illness:

ID: 1037841
Sex: F
Age:
State: OH

Vax Date: 01/19/2021
Onset Date: 01/01/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:thyroid went a bit more underactive; Test Name: heart monitor; Result Unstructured Data: Test Result:Unknown results; Comments: has SVG, she thinks

Allergies:

Symptoms: my head and ears closed down; my head and ears closed down; she doesn't sleep all night long; her body was shaking; my heart was beating out of my chest; felt a little lazy and tired; tinge-y pains in her heart; SVT; shortness of breath; This is a spontaneous report from a contactable consumer (patient). An 81-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261, Expiry date: 31May2021), via an unspecified route of administration on 19Jan2021 at Single Dose (dose unknown; by injection once to left upper arm) for covid-19 immunisation, levothyroxine sodium (SYNTHROID), orally from an unspecified date to an unspecified date at 0.75 mg once a day, and orally from an unspecified date to an unspecified date at 0.88 mg, once a day for thyroid disorder. Medical history included cancer, heart stents, irregular high blood pressure, breathing problem, underactive thyroid, back problem. The patient's concomitant medications were not reported. The patient took a flu shot 20 years ago for immunization and got really sick, took Pneumonia shots for immunization and was fine. On 19Jan2021, the patient had a little lazy and tired. On 21Jan2021, her heart was beating out of her chest, like she had a drum going off; beating so fast and rapid it, and her head felt closed off and ears- she could feel heartbeats in her head; on 21Jan2021, her body was shaking. In Jan2021, she had a couple tinge-y pains in her heart and shortness of breath; she had SVG, she thought, it was irregular heartbeats coming from the top of her heart. Details were as follows: On 22Jan2021, she woke up in the morning around 3-4 am and said "my heart was beating out of my chest and my head and ears closed down." The sensation subsided by 8 am. She called her family MD who did not respond so the following Monday she was in contact with her cardiologist who put her on a Holter monitor for a few days. He later told her she had SVT and prescribed a beta blocker for her to take. The patient stated "I am so allergic to medicine." She took Plavix after a stent 5 years ago and was fine taking it for a few years. Then she had another stent placed, was prescribed Plavix again, and was "so sick and dizzy and short of breath - it was the Plavix." States that she can take Cipro, ibuprofen, and synthroid and that her list of allergies is about "2 pages long." The patient wanted to know if she should take the second dose? her cardiologist advised that she not take it. Caller states she doesn't want to take the second dose and probably won't. She had a long history of allergic reactions to medications. She never had the flu, she hasn't had mumps, chicken pox, measles, occasionally, rarely a cold, about 20 years ago, she took a flu vaccine and got so sick after the shot and never took it again, she never got the flu, she does take Pneumonia shots and was fine. States she seems to have a natural immunity against typical disease you can catch. Other things, she had cancer, heart stents, and things of that sort, as far as infectious diseases, she had no problems. She had a reaction she thinks came from the COVID shot. She had a blood test and it showed her thyroid went a bit more underactive, so about 2 weeks ago, her Synthroid was raised from 0.75mg to 0.88mg, so 0.88mg was a new medication, but it was minimal. Communication: Caller was advised to slow down to assure accurate documentation. Synthroid 0.75mg: no NDC, lot, expiry. States this has been her only change in meds recently. She got that Synthroid the same day as she got her COVID vaccination, which was 19Jan2021, that afternoon, she got a Pfizer COVID vaccination. Also she got a prescription for her new Synthroid. The first day, 19Jan2012, she had no reaction at all, she took two Tylenol, someone suggested. She felt a little lazy and tired, for the rest of Tuesday, then Wednesday she felt more tired, she laid around on the couch watching TV, she stayed in her pajamas, had no serious reaction, just tired, then Tuesday and Wednesday, and then on Thursday night, she never did anything on Thursday either, she went to grocery store, was not feeling better, and on Thursday, 21Jan2021, at 3AM, she was awakened from sleeping, she did not sleep all night long, she got up often, her heart, she never had this before and had 3 stents, her heart was beating out of her chest, like she had a drum going off, it was beating so fast and rapid and her head felt closed off and ears- she could feel heartbeats in her head, and this went on, she didn't want to call, she lives by herself on a farm, and thought to wait and see if it goes away, and about 7AM, it was basically really bad from 3AM to 5AM, and at 7AM it went away, the rapid heartbeat was so far throughout and her body was shaking, and chest was so she never had it happen before. At 8AM she called her family doctor office, she wanted to go and see them and she was told she wasn't in that day, they would send a note in the computer to get back with her. The doctor did not get back with her all day Friday, and then she felt ok Friday, Saturday, and Sunday, she had a couple tinge-y pains in her heart and shortness of breath, but her heart didn't feel like it was beating out of rhythm. Then Monday morning she called her heart doctor, he said he doesn't know, it doesn't sound to him like it was the Synthroid, since it was a small change of dose, but he didn't know about COVID but he hadn't heard it as being an after effect, but he said to come by 2:30PM on Monday, to be fitted with a heart monitor, which she wears on her heart and it listens 24/7, listens to her heart function, so she wore that, he said to bring it back on Monday and leave it in the office, and she did that, she wore it Friday, Saturday, Sunday, and Monday, she never had that really huge feeling in her in heart anymore, she thought it was a waste of time, then she got a call from the heart doctor on Tuesday, he asked how she was feeling, she said she was fine, and sorry if she caused a commotion and he said she has a heart problem now, she said she didn't feel anything, but her heart is beating erratically, and he doesn't know why she didn't feel it, he said she has SVG, she thinks, it is irregular heartbeats coming from the top of her heart and he says he will send in a prescription to the pharmacy to get a beta blocker, she thinks Metoprolol. The pharmacy just got the medicine in and she is sitting there waiting now. He told her a couple months ago, her heart sounds fine, there seemed to be nothing the matter. She asked if it was the COVID vaccine, he said he doesn't know, and she asked if she should take the second dose on 09Feb2021, he said no, he doesn't think he wants her to take it, she is going to see him in 2 weeks and will try the medicine, but she wanted to report what happened to her. Has Pfizer heard of anyone having rapid heartbeat after COVID vaccination. States she is overweight. Second dose is scheduled for 09Feb2021, at 1PM. Caller states going from 0.75mg to 0.88mg on Synthroid is a minimal adjustment, it can go up to the 200's for underactive thyroid, it's minimum, she is supposed to take it on an empty stomach, first thing in the morning with water. She has had underactive thyroid since she was 20 years old, so for 40 years, and had no problems with Synthroid before. The patient had irregular high blood pressure: it is high during the night and normal during the day, and if she would take, she had been going to physical therapy, she had a back problem, it came from a different thing, her knee is bone on bone, and they want her to get a knee implant, but when she limps on her knee it makes her back, it hurts from not walking straight, so she went to physical therapy, and what was causing high blood pressure, if she took Ibuprofen or Aleve, it would significantly increase her blood pressure, so she has a sensitivity to pain medicine, especially Ibuprofen and Advil, it increases her blood pressure, and often when she doesn't have it in her system, her blood pressure is much more normal. She does not have Ibuprofen, Aleve, Advil to provide lot/expiry

Other Meds: SYNTHROID

Current Illness:

ID: 1037842
Sex: F
Age:
State: FL

Vax Date: 01/22/2021
Onset Date: 01/27/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 20210129; Test Name: blood pressure; Result Unstructured Data: Test Result:no notable or abnormal results; Test Date: 20210129; Test Name: blood tests; Result Unstructured Data: Test Result:no notable or abnormal results; Test Date: 20210129; Test Name: X-ray of her heart or lungs or something; Result Unstructured Data: Test Result:no notable or abnormal results; Test Date: 20210129; Test Name: testing her heart with EKG; Result Unstructured Data: Test Result:no notable or abnormal results

Allergies:

Symptoms: may have had a mini stroke; Bell's Palsy/developed facial drooping/her eye was drooping; fell; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (BNT162B2, Pfizer COVID-19 Vaccine; Batch/lot number: EL9262), via an unspecified route of administration injection to right upper arm on 22Jan2021 14:00 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing she was a fainter (She was a fainter, she just faints so she has a hard time getting shots. Pfizer COVID-19 Vaccine administered to her by nurse while she was in her car seat. She just asked the nurse to let her lay down in the car seat when injection was administered so that if she fainted she would not fall far; she was still getting the wash cloth on her head preparing when the Nurse had already finished administering the injection.); ongoing depressed sometimes (she was depressed sometimes, was stressed. She was the primary caregiver for her 96 year old mother. She had seen something about stress and COVID and shots and everything); ongoing Very tired (She was almost 80 years old so she was very tired often. She was the primary caregiver for her 96 year old mother. By the time she comes home at night around 21:30 she was just wiped.); Obesity (She was really overweight but she did not like the term obesity.); thyroid disorder; hypertension; Cataract and glaucoma in left eye; family history of ongoing facial paralysis (Dad had Bell's palsy that might have been 30 years ago. He died at age 87 years.); diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes). Concomitant medication included Levothyroxine at 100mcg taken once daily in the morning early before she eats with Start date unknown, but at least 10-15 years ago for Thyroid. Enalapril at 10mg taken once daily (Caller initially reported product name as Vasotec, but clarified it is not Vasotec, it is drop for eye cataract and glaucoma) for High blood pressure. Brimonidine with Strength unknown, 1 drop in both eyes twice daily, started maybe 1 year ago. Specified cataract and glaucoma in left eye; but drop was administered to both eyes; and left eye was eye affected by Bell's palsy for Cataract and glaucoma in left eye. The patient previously took codeine and experienced allergy with onset maybe about 50 years ago, she was not sure; occurred during dental procedure; had bad headaches but no lasting effects so they assumed allergy to codeine; she did not know if still has allergy but says she does if asked. The patient experienced bell's palsy/developed facial drooping/her eye was drooping on 29Jan2021 with outcome of recovering, may have had a mini stroke on an unspecified date with outcome of unknown , fell on 27Jan2021 with outcome of unknown (reported date of end of reaction was 27Jan2021), she could not blink that eye on 29Jan2021 with outcome of not recovered. Five days later she fell and developed facial drooping. HCP suggested she may have had a mini stroke causing facial drooping and the fall. She went to the ER on 29Jan2021 and the ER believed it was Bell's Palsy. She was still experiencing facial symptoms but they are improving. This consumer was administered her first dose if Pfizer COVID-19 Vaccine 22Jan2021. She reported having fell 27Jan2021. She was diagnosed with Bell's palsy in 29Jan2021 after having been seen in the emergency room. She is supposed to have the second dose/booster of Pfizer COVID-19 Vaccine on 12Feb2021. She called to ask if she should or should not still get the second dose as scheduled; and if Bell's palsy could be a reaction to the Pfizer COVID-19 Vaccine. The emergency room staff did not know how she got Bell's palsy, but knew she had the Pfizer COIVD-19 Vaccine and were kind of assuming the Bell's palsy was a reaction to the vaccine. She dis not have Bell's palsy bad. The emergency room staff thought at first she had a stroke before diagnosing her with Bell's palsy. On Wednesday, 27Jan2021 she had a friend named (Name withheld) who came over for tea. Patient has an oriental rug, and around 15:00 patient fell face first on oriental rug. She was just fine after the fall initially. She wonders if her having fell has anything to do with the Bell's palsy. She thinks it was the night of 27Jan2021 or 28Jan2021 when she asked her son if her face looked funny, did she look ok, because her face felt a little funny. She was looking in the mirror and her smile was looking crooked, and her eye looked like it was drooping. When she got up Friday, 29Jan2021 she could see her eye was drooping, and she could not blink that eye. She called her Ophthalmologist who saw her the afternoon of 29Jan2021 around 13:30-13:55. The Ophthalmologist said yeah something is going on with that eye. Her friend called his friend who is a Pediatric Neurologist that advised her to go to the emergency room. She was seen in the emergency room of (Hospital name withheld) around 17:00 on 29Jan2021. She was not admitted to the hospital at that time; but was evaluated and treated. She Bell's palsy outcome: she is doing so much better. She still has a hard time blinking her left eye, she still cannot blink her bad eye: left eye, without also closing her good eye: right eye. She is not drooling, she can drink without drooling. Her smile is still just a little crooked. She was given 2 prescriptions in the emergency room which were Prednisone and Valtrex. On 29Jan2021 in the emergency room they did tests including testing her heart with EKG; X-ray of her heart or lungs or something; took blood tests; and continuously took her blood pressure. There were no notable or abnormal results of any of those tests. They wanted her to go see her doctor last week but she did not have a chance to do so. She has an appointment with her primary doctor on Monday coming up. She has not yet seen her primary doctor about this. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None. The event Bell's palsy require a visit to Emergency Room, no to Physician Office. The patient was not hospitalized. No Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient underwent lab tests which included her heart with EKG; X-ray of her heart or lungs or something; took blood tests; and continuously took her blood pressure, all with no notable or abnormal results of any of those tests on 29Jan2021.

Other Meds: ENALAPRIL; BRIMONIDINE; LEVOTHYROXINE

Current Illness: Bell's palsy (Dad had Bell's palsy that might have been 30 years ago. He died at age 87 years.); Depressed mood (She is depressed sometimes, is stressed. She is the primary caregiver for her 96 year old mother.); Faint (She is a fainter/ She is a fainter, she just faints so she has a hard time getting shots. Pfizer COVID-19 Vaccine); Tiredness (Very tired/ She is almost 80 years old so she is very tired often. She is the primary caregiver)

ID: 1037843
Sex: F
Age:
State: CO

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: either tore a muscle in my lower back or herniated a disc; either tore a muscle in my lower back or herniated a disc; achey muscles, particularly in my back; muscles were really tight; Acute pain; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247), via an unspecified route of administration on 03Feb2021 12:00 (at the age of 53 years) at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) received on 13Jan2021 at 09:00 AM (at the age of 53 years) at single dose in left arm. Medical history included thyroid cancer in past, euthyroid on medication. The patient has no known allergies. Concomitant medication included Levoxythyroid 137 mcg. The patient reported the following: 'The morning after 2nd dose on 04Feb2021 at 07:00 AM, I had achey muscles, particularly in my back. My muscles were really tight. I bent down to pick something up and either tore a muscle in my lower back or herniated a disc because my muscles were so tight. Acute pain now. Cannot get out of bed'. AE resulted in doctor or other healthcare professional office/clinic visit. The patient was receiving pain meds for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The events had not resolved.

Other Meds:

Current Illness:

ID: 1037844
Sex: M
Age:
State: TX

Vax Date: 01/31/2021
Onset Date: 02/03/2021
Rec V Date: 02/18/2021
Hospital:

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

Allergies:

Symptoms: Trouble breathing with chest pressure; Trouble breathing with chest pressure; Rash on face with swollen fingers; Rash on face with swollen fingers; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received first dose of BNT162B2 (Lot number: 9264), via an unspecified route of administration on 31Jan2021 10:15 at single dose in the left arm for covid-19 immunisation. Medical history included hypertension and penicillin allergy. The patient's concomitant medications were not reported. On 03Feb2021 09:30, the patient experienced rash on face with swollen fingers and trouble breathing with chest pressure. The events result in Emergency room/department or urgent care. The patient did not receive any treatment for the events. 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 patient underwent lab tests and procedures which included Nasal Swab: negative on 03Feb2021. The outcome of the events was recovering. The following information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1037845
Sex: F
Age:
State: FL

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

Lab Data:

Allergies:

Symptoms: fever 120; vomit to dehydration point; vomit to dehydration point; a lot of discomfort; hot feeling inside of my body like I was burning; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot unknown: true) via an unspecified route of administration at arm right on 03Feb2021 at a single dose for COVID-19 immunization. The patient was not pregnant. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: brand: Pfizer; lot unknown: true) at left arm on 13Jan2021 at 04: 45 PM at a single dose for COVID-19 immunization. Other medical history included asthma and known allergies: penicillin. Concomitant medications the patient received within 2 weeks of vaccination included ascorbic acid (VITAMIN C) and multivitamins for women. No other vaccine in four weeks. 2 hours after vaccination the patient started with fever 120 (no units specified) and a lot of discomfort; early morning she had vomit to dehydration point, hot feeling inside of her body like she was burning. She went to urgency room. Treatment received for the adverse event included received electrolytes for dehydration and ondansetron (ZOFRAN, reported as Zofram). The event start date was reported on 03Feb2021 at 01:15 PM. The outcome of all events was resolving. No COVID prior vaccination and no COVID tested post vaccination.

Other Meds: VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1037846
Sex: M
Age:
State: MO

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 20210125; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: activation of a long dormant (over 12 years) auto-immune disorder, bullous pemphigus; day 5-8 was intense GI distress with stabbing stomach pain; day 5-8 was intense GI distress with stabbing stomach pain; general malaise; Day 1-4 was significant fatigue and headache; Day 1-4 was significant fatigue and headache; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 14Jan2021 at 10:00 at a single dose on right arm for COVID-19 immunisation. Medical history included high cholesterol, blood pressure abnormal, degenerative arthritis and allergies to penicillin and NSAIDS. Concomitant medications included gabapentin, lisinopril, levothyroxine and atorvastatin. On days 1-4, the patient experienced significant fatigue and headache on 15Jan2021. On days 5-8, there was intense GI distress with stabbing stomach pain, following these events has been continued with fatigue and general malaise. Most problematic was activation of a long dormant (over 12 years) auto-immune disorder, bullous pemphigus, which attacks soft tissue areas on the body with blisters and sloughing skin. This is a very uncomfortable experience to go through. The patient's healthcare provider is aware and treating him for such. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 25Jan2021. Therapeutic measures were taken as a result of day 1-4 was significant fatigue and headache, day 5-8 was intense gi distress with stabbing stomach pain and general malaise. The outcome of the events was not recovered.

Other Meds: GABAPENTIN; LISINOPRIL; LEVOTHYROXINE; ATORVASTATIN

Current Illness:

ID: 1037847
Sex: F
Age:
State: KY

Vax Date: 01/16/2021
Onset Date: 01/24/2021
Rec V Date: 02/18/2021
Hospital: Y

Lab Data: Test Name: Platelets; Result Unstructured Data: Test Result:241; Comments: Prior to the shot my platelets were 241.; Test Date: 202101; Test Name: Platelets; Result Unstructured Data: Test Result:89; Comments: now dropped to 89; Test Date: 20210124; Test Name: Platelets; Result Unstructured Data: Test Result:142; Comments: my platelets dropped to 142 first day there then 126; Test Date: 2021; Test Name: Platelets; Result Unstructured Data: Test Result:126; Comments: when she was released from the hospital; Test Date: 2021; Test Name: Platelets; Result Unstructured Data: Test Result:47; Comments: platelets dropped again; Test Date: 20210126; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: Platelets dropped significantly after taking the shot. Prior to the shot my platelets were 241.; Extreme fatigue; weakness; dizziness; heart racing; nose bleeds; unable to walk or stand up without assistance; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer Biontech; lot number: unknown; lot unknown reason: true received at hospital & not sure what batch they gave her) via an unspecified route of administration at right arm on 16Jan2021 at 10:00 AM at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient was not pregnant. Facility type vaccine was at hospital. Adverse events were reported as follows: platelets dropped significantly after taking the shot. Prior to the shot her platelets were 241. Extreme fatigue, weakness, dizziness, heart racing, nose bleeds, and also was unable to walk or stand up without assistance - overall poor health. Condition intensified to severe 1-3 days after the shot and she went to the (Hospital Name) ER on 26Jan2021. She was admitted to the hospital. During that stay her platelets dropped to 142 first day there then 126 when she was released from the hospital. A week later she went to (Name) MD for a planned office visit & my platelets were tested again and her platelets how now dropped to 89. A week after this she went back to (Name) MD and her platelets dropped again and this time now 47. Prior to the shot she have no history of low platelets or this type of unusual she'll feeling. The adverse event start date was reported as on 24Jan2021. AE resulted in emergency room/department or urgent care, hospitalization for 4 days. It was unknown if treatment received for events. The outcome of events was not recovered. No covid prior vaccination. Covid test type post vaccination included Nasal Swab on 26Jan2021: negative. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1037848
Sex: M
Age:
State: TX

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Hallucinations; He seems impaired mental and emotionally; He became unruly, hostile, angry, indignant; Unreasonable dreams; Belligerent, lost all sense of decorum, couldn't figure out where he was; Cried; This is a spontaneous report from a contactable consumer reporting for himself. A 80-years-old male patient received bnt162b2 (BNT162B2; Lot #ENS318) vaccine , via an unspecified route of administration in the left arm on 30Jan2021 11:15 at single dose for covid-19 immunisation . Medical history included Parkinson's disease, mobility decreased . Concomitant medication included thyroid (THYROID), carbidopa, levodopa (RYTARY). The patient previously took codeine and experienced drug hypersensitivity. One hour after receiving the vaccine, the patient experienced hallucinations on 30Jan2021 12:15 with outcome of recovering , he seems impaired mental and emotionally on 30Jan2021 12:15 with outcome of recovering , he became unruly, hostile, angry, indignant on 30Jan2021 12:15 with outcome of recovering , unreasonable dreams on 30Jan2021 12:15 with outcome of recovering , belligerent, lost all sense of decorum, couldn't figure out where he was on 30Jan2021 12:15 with outcome of recovering , cried on 30Jan2021 12:15 with outcome of recovering. All the reported events were considered Important Medical Events.

Other Meds: THYROID; RYTARY

Current Illness:

ID: 1037849
Sex: M
Age:
State: GA

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Name: colonoscopy; Result Unstructured Data: Test Result:no diagnosed problems; Comments: in last 5 years with no diagnosed problems.

Allergies:

Symptoms: Blood in stools the next day after getting vaccine.; This is spontaneous case from a contactable consumer reported for himself. A 65-year-old male patient received 1st dose of BNT162B2 (lot# EN5318) on 04Feb2021 00:00 (reported as 03Feb2021 12:00 PM) at single dose on Right arm for covid-19 immunization. Medical history was diabetes from Aug2018. Concomitant drug was Insulin lispro (HUMALOG) for Diabetic. Patient experienced Blood in stools the next day after getting vaccine (04Feb2021 08:15 PM). Never had this problem before. Have had colonoscopy in last 5 years with no diagnosed problems. No treatment received. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was unknown. No follow-up attempts are possible. No further information expected.

Other Meds: HUMALOG

Current Illness:

ID: 1037850
Sex: M
Age:
State:

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: a fever; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported that a 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) via an unspecified route of administration at the age of 37-years, on 26Jan2021 at single dose for COVID-19 immunization, in workplace clinic. There was no other medical history, no known allergies, no other vaccine in four weeks, no COVID-19 prior vaccination. Concomitant medications were not reported. At 18:30 (06:30 PM) on 26Jan2021, the patient developed a fever overnight after receiving first dose. No treatment received. Outcome of the event was recovered/resolved in Jan2021. No COVID-19 tested post vaccination. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1037851
Sex: F
Age:
State: VA

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 20210129; Test Name: BLOOD PRESSURE; Result Unstructured Data: Test Result:ELEVATED

Allergies:

Symptoms: Drooping of left cheek; Elevated blood pressure; nodes in neck enlarged; sore to touch; headache; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261, expiration date was not reported), via an unspecified route of administration on 28Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included allergies and known allergies to sulfa drugs. Patient was not pregnant at the time of vaccination. Concomitant medication included ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION), iron, colecalciferol (VITAMIN D), acetylsalicylic acid (ASPIRIN). The patient previously took first dose of bnt162b2 on 07Jan2021 09:45 on the left arm for COVID-19 immunization. The patient experienced elevated blood pressure, all nodes in neck enlarged and sore to touch, drooping of left cheek and headache on 29Jan2021 22:00. Condition persisted for 4 days. The patient received an unspecified treatment. The patient had a visit to the doctor and emergency room. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient was recovering from the events at the time of the report.

Other Meds: PRESERVISION; IRON; VITAMIN D; ASPIRIN

Current Illness:

ID: 1037852
Sex: M
Age:
State:

Vax Date: 01/21/2021
Onset Date: 01/26/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 20210126; Test Name: Covid-19/Rapid test; Result Unstructured Data: Test Result:Negative; Test Date: 20210126; Test Name: Covid-19nasal swab; Test Result: Positive

Allergies:

Symptoms: they described it as a nasal swab and that test came back positive; they described it as a nasal swab and that test came back positive; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported similar events for 2 patients. This is the first of 2 reports. A male patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 26Jan2021, the patient did a rapid test which came negative. The patient did a 2 day test, and get the results back within a 2 days that was, they described it as a nasal swab and that test came back positive. The outcome of events was unknown. Information on lot number/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021123778 same report/drug/AE, different patient.

Other Meds:

Current Illness:

ID: 1037853
Sex: F
Age:
State: NV

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

Lab Data:

Allergies:

Symptoms: swelled her arm up from the injection site all the way down to her wrist; swelled her arm up from the injection site all the way down to her wrist; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program Pfizer First Connect. A 73-year-old female patient received first dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (trade name unknown, Solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date at single dose and second dose via an unspecified route of administration on 2019 (about 6 months after first dose) at single dose for immunization. Medical history included ongoing high blood pressure. The patient's concomitant medications were not reported. It was reported that, patient received first dose of pneumonia vaccine and she had no adverse event with; Second dose was given in 2019 about 6 months after first dose. Second dose of Pneumonia Vaccine swelled her arm up from the injection site all the way down to her wrist on an unspecified date in 2019; she went to the urgent care for that. They gave her some medicine (unspecified) and eventually the adverse events went away. Second dose was when she experienced adverse event. The outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.

Other Meds:

Current Illness: Hypertension

ID: 1037854
Sex: F
Age:
State:

Vax Date: 01/21/2021
Onset Date: 01/26/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 20210126; Test Name: 2 day test/nasal swab; Test Result: Positive ; Test Date: 20210126; Test Name: rapid test; Test Result: Negative

Allergies:

Symptoms: they described it as a nasal swab and that test came back positive; they described it as a nasal swab and that test came back positive; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported similar events for 2 patients. This is 2nd of 2 reports. This consumer reported for a female patient (wife) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, they did 2 test, they did a rapid test which both of them came negative. And then they did what they call a 2 day test, could get the results back within a 2 days that was, they described it as a nasal swab and that test came back positive for both of them. The outcome of the events was unknown. Information of lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021123696 same report/drug/event, different patient.

Other Meds:

Current Illness:

ID: 1037855
Sex: F
Age:
State: OK

Vax Date: 01/14/2021
Onset Date: 01/24/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 20210124; Test Name: Covid-19; Test Result: Positive

Allergies:

Symptoms: was tested for COVID and she tested positive for the virus; was tested for COVID and she tested positive for the virus; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. Medical history included cancer, she had her stomach or whatever operated on. The patient's concomitant medications were not reported. The patient was tested for covid and she tested positive for the virus on 24Jan2021, she felt terrible, but she was still just in her home, with like a plastic covering over her door. She was instructed to just take paracetamol (TYLENOL) and Zinc. The outcome of the events was unknown. Information on lot number/batch number has been requested.

Other Meds:

Current Illness:

ID: 1037856
Sex: F
Age:
State: TN

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

Lab Data:

Allergies:

Symptoms: attempted to kill herself; acting differently; This is a spontaneous report from a Pfizer Sponsored Program . A contactable consumer (patient's parent) reported a female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization this morning (03Feb2021). Medical history included: autism, depression and anxiety. Concomitant medication was not reported. The patient experienced acting differently and she attempted to kill herself after the first dose of the vaccine today (03Feb2021). Action taken for BNT162B2 was not applicable. Outcome of the events was unknown. Information on Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1037857
Sex: F
Age:
State: NC

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248), via an unspecified route of administration at Right Arm on 27Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced right arm pain on 28Jan2021. The date of her second schedule dose on 17Feb2021. The outcome was recovered on 28Jan2021.

Other Meds:

Current Illness:

ID: 1037858
Sex: F
Age:
State: NY

Vax Date: 01/28/2021
Onset Date: 01/30/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Gastrointestinal issues; threwup/vomiting; Diarrhea; This is a spontaneous report from a contactable consumer (patient's daughter). A 96-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9264, expiry date unknown) in the hospital via an unspecified route of administration on 28Jan2021 on the left arm at a single dose for COVID-19 immunization. The patient was concomitantly taking hydrochlorothiazide (manufacturer unknown) for blood pressure. It was reported that the patient seemed to be okay after receiving the first vaccination when they came home that day but today, Saturday, 30Jan2021, 2 days later, she has had some gastrointestinal issues, she threw up this morning in her bed and now she has a case of diarrhea. The patient doesn't seem to have any fever, she is cool. She doesn't seem to have any respiratory problems but mostly this is gastrointestinal problems. The patient is alert but she had a bout of vomiting and diarrhea on 30Jan2021. The reporter was wondering if the agent had any thoughts about whether or not this was the reaction to the vaccine or something else. The patient did not receive treatment for the events. The outcome of the events was unknown.

Other Meds: HYDROCHLOROTHIAZIDE

Current Illness: Blood pressure abnormal

ID: 1037859
Sex: M
Age:
State:

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vomiting; This is a spontaneous report from a non-contactable consumer (reporting for himself). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on 29Jan2021 at SINGLE DOSE (right arm, dose 1) for covid-19 immunisation. Medical history included allergies to penicillin and mushrooms from an unspecified date. Patient did not have COVID prior vaccination. Patient was not tested post vaccination. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced vomiting on 30Jan2021. No treatment was provided. Event outcome was recovering. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1037860
Sex: F
Age:
State: NY

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262 and expiration date not provided), via an unspecified route of administration (left arm) second dose on 28Jan2021 11:00 at single dose for Covid-19 immunization. The patient's medical history included Seasonal allergies, allergic asthma, Allergies: Penicillin, and Allergies: Grapefruit. The patient was not pregnant at the time of vaccination. The patient's concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE). The patient's historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 expiration date not provided) first dose on 07Jan2021 left arm (age at the time of vaccination was 31-year-old) for Covid-19 immunization. On 29Jan2021 11:00, the patient experienced Swollen lymph nodes (left armpit). The patient did not received treatment for the event. The outcome of the event was not recovered.

Other Meds: BLISOVI 24 FE

Current Illness:

ID: 1037861
Sex: M
Age:
State: IL

Vax Date: 01/20/2021
Onset Date: 01/23/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: cholesterol test; Result Unstructured Data: Test Result:fine, nothing was found there; Test Date: 202101; Test Name: Blood test; Result Unstructured Data: Test Result:fine, nothing was found there; Test Date: 202101; Test Name: liver test; Result Unstructured Data: Test Result:fine, nothing was found there

Allergies:

Symptoms: I was dizzy all along and almost fainted; I was dizzy all along and almost fainted; migraine; This is a spontaneous report from a contactable consumer (patient). This 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 20Jan2021 for COVID-19 immunization. Medical history included sleep apnea; high blood pressure; high cholesterol; borderline diabetes. Concomitant medications included losartan; alirocumab (PRALUENT, injection) on 20Jan2021. Since 23Jan2021, patient was dizzy all along and almost fainted and was still having symptoms of mild migraine and he don't know like some light sensitivity. Doctor believed it was from vaccine. Patient was wondering how long was this going to be last as he had second shot coming out. He didn't think it was an adverse reaction and he thought he should get the second shot. But this was continuing to me and it had already been two weeks and patient still having symptoms of mild migraine. Patient was worried about taking the second shot as a result. He had never had a migraine before and was told it was probably from the vaccine and that was not something he wanted to hear. Patient wanted to know if this was normal to still be having this side effect for this long. Patient was taking acetaminophen (for migraine), it was not a TYLENOL, it was from a different brand. Patient did liver and cholesterol test and blood test in Jan2021 at Cardiologist and they came back fine, nothing was found there. The outcome of event migraine was not resolved. The outcome of rest events was unknown. Information on the lot/batch number has been requested.

Other Meds: LOSARTAN; PRALUENT

Current Illness:

ID: 1037862
Sex: M
Age:
State: VA

Vax Date: 01/26/2021
Onset Date: 01/29/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: Kidney; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: Severe pain in the joint of the arm that the shot was given and in the shoulder/Throbbing in the shoulder; Pinky finger was red and swollen; Pinky finger was red and swollen /Finger is swollen down to the knuckle; Very uncomfortable; Reluctant to use that arm because it is painful; This is a spontaneous report from a contactable consumer reporting for her husband. A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246, expiry date unknown) via an unspecified route of administration on 26Jan2021 at single dose into his arm (shoulder) for COVID-19 immunization. Medical history included wheelchair user, nephrectomy on an unspecified date, previous immunotherapy (unspecified medication, first dose in Dec2019, second dose in Mar2020) and side effects (Bullous pemphigoid, it's blistering of the skin) from the immunotherapy. The patient had a test for kidney function in Jan2021, results not reported. The patient received the vaccine on 26Jan2021 and he experienced severe pain in the joint of the arm that the shot was given, in his shoulder and his pinky finger was red and swollen and that finger was swollen down to the knuckle. He was very uncomfortable and he said it was throbbing in the shoulder and he was reluctant to use that arm because it was painful. The event onset date was 29Jan2021. The patient was given paracetamol (TYLENOL) as treatment. The result of the events was unknown.

Other Meds:

Current Illness: Wheelchair user

ID: 1037863
Sex: F
Age:
State: FL

Vax Date: 01/23/2021
Onset Date: 01/25/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nausea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing acid reflux, ongoing Meniere's disease, and unspecified health issues. Concomitant medication included rivaroxaban (XARELTO). On 25Jan2021, a couple of days later from vaccination, the patient had nausea. She wanted to know if the nauseous feeling had to do with the vaccine or the acid reflux or the Meniere's. The patient asked whether she should get the second shot if she is not feeling well on 13Feb2021, which is when she is supposed to get the second shot. Outcome of the event was unknown. Information about batch/lot number has been requested.

Other Meds: XARELTO

Current Illness: Acid reflux (esophageal); Meniere's disease

ID: 1037864
Sex: M
Age:
State: TX

Vax Date: 01/22/2021
Onset Date: 01/01/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: This is a spontaneous report from a contactable consumer, the patient's wife. A 68-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 22Jan2021 (at the age of 68-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included stroke on an unknown date. It was also reported that the patient was exposed to someone diagnosed with COVID-19 after receiving the vaccination (Jan2021); but the patient had not been tested for COVID-19. Concomitant medications were not reported. In Jan2021, after the vaccination, the patient experienced watery eyes, runny nose, a slight cough, and stomach pain. The patient went to the walk-in clinic for the watery eyes and runny nose. He was given unspecified medication for the slight cough. The clinical outcomes of the watery eyes, runny nose, and slight cough were recovered in Jan2021; while that of the stomach pain was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

Date Died: 02/09/2021

ID: 1037865
Sex: M
Age:
State: FL

Vax Date: 01/10/2021
Onset Date: 01/27/2021
Rec V Date: 02/18/2021
Hospital: Y

Lab Data: Test Date: 20210127; Test Name: Nasal Swab; Result Unstructured Data: Test Result:COVID-19 virus test positive

Allergies:

Symptoms: respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed/died on 09Feb2021 from respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed/died on 09Feb2021 from respiratory failure from COVID19; This is a spontaneous report from a contactable physician. An 89-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 10Jan2021 at 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient received one dose of Pfizer vaccine on 10Jan2021. The patient was presented to the ER with COVID symptoms and was diagnosed on 27Jan2021. Patient subsequently died on 09Feb2021 from respiratory failure from COVID19. It was unknown if autopsy was done. The patient was tested for COVID post vaccination via nasal swab: covid-19 virus test positive on 27Jan2021. The events resulted in emergency room/department or urgent care, hospitalization, and patient died. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID post vaccination and respiratory failure with fatal outcome, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. More information on the underlying medical condition in this 89-year-old male patient is required for the Company to make a more meaningful causality 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 RA, IEC, as appropriate.; Reported Cause(s) of Death: presented to the ER with COVID symptoms and was diagnosed on 27Jan. Patient subsequently died on 09Feb from respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed on 27Jan. Patient subsequently died on 09Feb from

Other Meds:

Current Illness:

ID: 1037866
Sex: M
Age:
State: TX

Vax Date: 12/22/2020
Onset Date: 01/09/2021
Rec V Date: 02/18/2021
Hospital: Y

Lab Data: Test Date: 20210112; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210113; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: Premature ventricular contractions; Postural Orthostatic tachycardia syndrome; Dizziness; shortness of breath; chest pain; This is a spontaneous report from a contactable physician (patient). A 34-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EL0140, in Hospital, via an unspecified route of administration in left arm, on 22Dec2020 (at 34 years of age) at single dose for COVID-19 immunization. Medical history included prediabetes (glucose tolerance impaired) from an unknown date. The patient didn't have COVID-19 prior to vaccination. Concomitant medication included metformin and multivitamins. On 09Jan2021 the patient experienced premature ventricular contractions, postural orthostatic tachycardia syndrome, dizziness, shortness of breath and chest pain. The events resulted in Emergency room/department or urgent care access and hospitalization as life threatening events. The patient was treated with diltiazem, fludrocortisone, aspirin and atorvastatin. He remained in hospital 2 days and then he was discharged. The patient underwent COVID-19 test (nasal swab) on 12Jan2021 and 13Jan2021 and both gave negative results. The patient had not recovered yet from the reported events at the time of the report.; Sender's Comments: The causal relationship between BNT162B2 and the events ventricular extrasystoles, postural orthostatic tachycardia syndrome, dizziness, dyspnea and chest pain cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. The patient is a young adult with known prediabetes, but no other comorbidities reported. Information on tests done during admission, clinical course and working diagnosis would be helpful in further assessment of this case. 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: METFORMIN

Current Illness:

Date Died:

ID: 1037867
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Caller's mother received both doses of the Pfizer covid vaccine; within a month of receiving the vaccine, the caller's mother died.; This is a spontaneous report from a contactable consumer reported for the mother. A female patient of unknown age received both doses of vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unknown dates at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. Within a month of receiving the vaccine, the patient died. It was unknown if an autopsy was performed. Information on the Lot/Batch number has been requested ; Reported Cause(s) of Death: within a month of receiving the vaccine, the caller's mother died

Other Meds:

Current Illness:

ID: 1037868
Sex: F
Age:
State: CA

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: At 4am I woke up sweating/sweating profusely; nausea/extremely nauseous; dizziness/dizzy/extremely dizzy; vomit; lost bladder control; I was very weak, I couldn't wipe. I couldn't hold a cloth/had no hand strength; terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life; a little arm pain; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at deltoid left on 26Jan2021 at 13:20 (at the age of 73 years) at single dose for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. The patient reported a little arm pain on 26Jan2021, I woke up sweating/sweating profusely, nausea/extremely nauseous, dizziness/dizzy/extremely dizzy and vomit , all on 27Jan2021 at 4:00; lost bladder control, terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life, and those are classic heart attack symptoms, she had no cardio and respiratory symptoms; I was very weak, I couldn't wipe. I couldn't hold a cloth/had no hand strength, all on 27Jan2021. Therapeutic measures were taken as result of little arm pain an included treatment with aspirin. The patient outcome of the events was recovered. The information on the batch number has been requested.

Other Meds:

Current Illness:

ID: 1037869
Sex: M
Age:
State: NC

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 02/18/2021
Hospital: Y

Lab Data: Test Date: 20210212; Test Name: Body temperature; Result Unstructured Data: Test Result:Fever

Allergies:

Symptoms: Fever; unresponsive; This is a spontaneous report from a non-contactable consumer. An elderly male patient received the second BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 11Feb2021 for covid-19 immunisation . The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On 12Feb2021, the patient developed fever, unresponsive. The events required a visit to the emergency room. The patient was hospitalized and condition was life threatening. Therapeutic measures were taken as a result of fever and unresponsive. The outcome of the events was not recovered. No follow-up attempts are possible; information on lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1037870
Sex: M
Age:
State: CA

Vax Date: 01/21/2021
Onset Date: 01/01/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 20210109; Test Name: Covid test/Covid Nasal Swab Test; Test Result: Positive ; Test Date: 20210129; Test Name: X-ray; Result Unstructured Data: Test Result:Double Covid Pneumonia

Allergies:

Symptoms: Double Covid Pneumonia; feeling tired; weak; doctors were concerned that the Covid vaccine had taxed his immune system; This is a spontaneous report from a contactable consumer (patient; a direct care staff for a group home). A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 613247, expiration date: May2021), intramuscularly to the left arm on 21Jan2021 at 0.3 mL, single for COVID-19 immunization. He was given the vaccine at work. It's a group home facility. The patient's medical history included high blood pressure, and positive for the covid virus from 09Jan2021 to an unknown date. Concomitant medication included benazepril from 22Jan2021 and ongoing for high blood pressure. He saw a doctor on 22Jan2021 and he prescribed Benazepril; it was started on 22Jan2021. The patient previously received a flu vaccine on Sep2020 for immunization. The patient called about the Covid vaccine. He reported that on 09Jan2021, he was positive for the COVID virus. He was then cleared on 16Jan2021 to go to work. His work then offered the COVID vaccine on 21Jan2021 and he got it. Then on 29Jan2021, he was diagnosed with Double Covid Pneumonia. His doctors were concerned that the Covid vaccine had taxed his immune system. The patient was a direct care staff for a group home. He cares for adults that are developmentally challenged. He has a CPR license. The patient confirmed that he received his first dose of the vaccine on 21Jan2021. He started feeling tired and weak about evening of 22Jan2021. He then started feeling out of breath Wednesday 27Jan2021, 28Jan2021 Thursday, and Friday 29Jan2021. He thought maybe he might be having a normal side effect. He stated that the Double Covid Pneumonia was detected on the X-ray that took place on the 29Jan2021. He is scheduled for second dose on 11Feb2021. The patient stated that the weakness was horrible. They gave him antibiotics; he was starting to recover. He was off of work till Saturday due to the pneumonia. He doesn't know if he will be getting the second dose. The patient was prescribed antibiotic Cefuroxime Axetil 500mg 1 tablet by mouth twice a day for 7 days, antibiotic Doxycycline Monohydrate 100mg 1 tablet by mouth twice a day 7 days, a Steroid Prednisone 20mg 2 tablets by mouth daily at same time in morning for 5 days, and a breather Albuterol HFA 90mcg/att inhale 2 puffs by mouth every 4 hours as needed for shortness of breath, wheezing, or cough. It was reported that they did a Covid Nasal Swab Test on 09Jan2021, then on that Sunday or Monday he got positive result, and by that time he had fatigue. After he got the vaccine, he went back to work. After the vaccine, it was a big surprise about the double Covid pneumonia, and they think it was taxing the immune system. He has had no issues with vaccines in the past. He had a Flu vaccine recently and there was no problem, that was Sep2020. He wants to know should he get the second dose.The outcome of the events double Covid pneumonia and "doctors were concerned that the Covid vaccine had taxed his immune system" was unknown. Regarding his double Covid pneumonia, the doctor said his O2 level will determine how he is doing. They will also do another lung X-ray. The doctor said the antibiotic should take care of it. The doctor did warn him that things could get worse. They said he can possibly go back to work on 06Feb2021, but this is not certain at the moment; it could change.

Other Meds: BENAZEPRIL

Current Illness:

ID: 1037871
Sex: F
Age:
State: MA

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

Lab Data:

Allergies:

Symptoms: faint; slightly dizzy; weak; This is a spontaneous report from a contactable nurse (patient). A 92-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL9262), intramuscular in the left arm on 01Feb2021 12:30 at a single dose for covid-19 immunization. The patient has no medical history and concomitant medications. On 02Feb2021 16:00, the patient faint, slightly dizzy, weak and had to grab counter. Within 5-10 minutes it was gone and she was feeling fine. The patient added that it would have been serious if she hit the floor, but she did not. The outcome of the events was recovered on 02Feb2021.; Sender's Comments: Based on the close temporal relationship, the association between the events faint, slightly dizzy and weak 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: 1037872
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: deafened her for ten minutes; This is a spontaneous report from a contactable consumer patient. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient got the vaccine on an unspecified date and it deafened her for ten minutes. She was not sure if that was a side effect that she should be worried about. The patient recovered from the event on an unspecified date. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1037873
Sex: M
Age:
State: MD

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/18/2021
Hospital: Y

Lab Data: Test Name: Blood pressure abnormal; Result Unstructured Data: Test Result:100 and something; Test Name: Blood pressure abnormal; Result Unstructured Data: Test Result:low; Test Date: 20210131; Test Name: Blood pressure abnormal; Result Unstructured Data: Test Result:91/73; Comments: Blood pressure low; Test Date: 20210131; Test Name: EKG; Result Unstructured Data: Test Result:Atrial Fibrillation/Flutter - Heart Rate: 160s; Test Name: heart rate; Result Unstructured Data: Test Result:high; Test Name: heart rate; Result Unstructured Data: Test Result:better; Test Date: 20210129; Test Name: heart rate; Result Unstructured Data: Test Result:irregular; Test Date: 20210131; Test Name: heart rate; Result Unstructured Data: Test Result:160

Allergies:

Symptoms: High pulse rate; Blood pressure low; Sweating; Clammy; wasn't feeling well; Chills; feeling feverish without having a fever; Fatigue/Tiredness; irregular heartbeat; he said the nausea started later on Friday evening; he had a sore right arm after getting the COVID-19 Vaccine; He said he already has stomach trouble; pain in his chest.; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date not reported), via an unspecified route of administration in the right arm on 29Jan2021 at single dose for COVID-19 immunization. The patient was vaccinated at a hospital. Medical history included heart rate irregular and blood pressure high. Concomitant medications were none. The patient said he had an irregular heartbeat after getting his first dose of the COVID-19 Vaccine on Friday, 29Jan2021. He said he had to go to the Emergency Room on Sunday, 31Jan2021. He clarified he checked his blood pressure at home and his blood pressure was low at 91/73. He said he also had a high pulse rate of 160, or better, for 9-1/2 hours. He said the only thing he can attribute his low blood pressure and high pulse rate to is the COVID-19 Vaccine. He said he hasn't heard anything about the COVID-19 Vaccine being related to having an effect on the heart, but he personally believes it was his first COVID-19 Vaccine dose that caused his low blood pressure and high pulse rate. He clarified after receiving the COVID-19 Vaccine on Friday, 29Jan2021, he had a sore right arm after getting the COVID-19 vaccine, fatigue, tiredness, and nausea. He said on Saturday, 30Jan2021, he wasn't feeling well. He said he recognized a small amount of chills, feeling feverish without having a fever, and sweating. He said his wife checked his temperature a few times on Saturday, 30Jan2021, and he never had a fever, but he felt clammy. He said he had noticed the nausea more than anything else. He said he maybe should have checked his blood pressure on Saturday, 30Jan2021. He said he didn't check his blood pressure until Sunday morning, 31Jan2021, and when he saw his low blood pressure and high pulse rate, he called the hospital and eventually drove to the Emergency Room. He said by the time he had got to the Emergency Room his blood pressure had went up to "100 and something", but his pulse rate never changed, and his pulse was still 160. He said the doctor gave him several medications to try to get his pulse rate to come down. He said the doctor had given him a medication that was supposed to bring his pulse down. He said then the doctor had to add something else in a syringe to go with the other medication to bring his pulse down. He said he wasn't sure of the medication's name. He clarified he never noticed his pulse rate was high until he took his blood pressure on Sunday, 31Jan2021. He said he felt the nausea start later Friday evening (29Jan2021). He said he already has stomach trouble anyways that he takes medicine for, so he took a pill, but the nausea continued. He clarified he took 1 Omeprazole 20mg capsule that was dispensed in a pharmacy bottle, but stated the Omeprazole 20mg prescription looked like it expired in 2017. He said he knows he has a newer Omeprazole prescription, but did not know where the prescription bottle was. He reported on Saturday, 30Jan2021, he just laid around. He said he did not feel as bad on Saturday, as he did on Sunday, 31Jan2021. He said he called the Emergency Room on Sunday morning, and went to the Emergency Room. He said he didn't feel his 160 pulse rate. He said he was told by the doctor in the Emergency Room that his fast heart rate had his heart beating like he was having a stress test. He reported he doesn't know if he wants to get the second COVID-19 Vaccine shot after what he experienced this past weekend. He reported he only takes blood pressure medicine that he has been on for a while. He reported he had several EKGs done on Sunday, 31Jan2021, while he was in the Emergency Room. He said the EKG showed Atrial Fibrillation/flutter with a heart rate in the 160s. He reported while he was in the Emergency Room he was given IV Heparin, IV Potassium, Potassium pills, and Amiodarone in a pill and IV form. He said the doctor added another IV medicine in a syringe, but he doesn't know the name of the medicine. He said the doctor also gave him IV Morphine because he had pain in his chest. He said the doctor said his chest pain was being caused by his heart trying to go back into a regular rhythm. He reported he was in the Emergency Room for 11-12 hours before he was admitted to the hospital. He said his pulse rate wasn't coming down and stayed at 160 for 9-1/2 hours. He said the doctor wanted to admit him to the hospital, so he could have a procedure to make sure the high pulse rate didn't damage his heart. He said on Monday, 01Feb2021, he had a procedure where they went through his wrist and put a dye in his heart to see if the stress from his high pulse rate damaged his heart. He said his heart wasn't damaged, so he was discharged from the hospital later in the day on 01Feb2021. He clarified his blood pressure was good by the time the first or second EKG was performed in the Emergency Room. He clarified he already had an issue with sweating before he received his first dose of the COVID-19 Vaccine. He said he is still sweating, but he doesn't know if that is because of the COVID-19 vaccine. Clinical outcome of high pulse rate and blood pressure low was recovered on 31Jan2021; nausea, fatigue/tiredness recovered on 02Feb2021; chills, feeling feverish recovered on an unspecified date; sweating was not recovered; while for the other events was unknown.

Other Meds:

Current Illness:

ID: 1037874
Sex: F
Age:
State: AK

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

Lab Data:

Allergies:

Symptoms: fluttering heart; Started light headed; sharp chest pain; hard to take a breath; Face turned hot and bright red/Felt like my head was on fire; Body ache all night; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265, expiry date: unknown), via an unspecified route of administration on 02Feb2021 at single dose (Right arm) for COVID-19 immunization. Medical history included Mild Asthma and Known allergies: Penicillin, Sulfa, Levoquin. Patient is not pregnant. Concomitant medication included prednisone (short course). The patient previously took bnt162b2 for COVID-19 immunization {product=COVID 19, brand=Pfizer,lot number=EJ1686, lot unknown=False, administration date=12Jan2021, vaccine location=Right arm, dose number=1}. It was reported that the patient started light headed, then sharp chest pain, fluttering heart, hard to take a breath. Face turned hot and bright red. Felt like my head was on fire. Body ache all night. Started happening about 3 hours after vaccine dose. Events started on 02Feb2021 13:00. Did not go to ER, no treatment. Stayed home and rested. The outcome of the events was recovering.

Other Meds: PREDNISONE

Current Illness:

ID: 1037875
Sex: M
Age:
State: PA

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

Lab Data: Test Date: 20210202; Test Name: Nasal Swab (NAAT); Test Result: Negative

Allergies:

Symptoms: dizzy; nauseous; left arm weakness/left leg weakness; numbness and tingling of his left fingers; numbness and tingling of his left fingers; lost balance; fell; This is a spontaneous report from a contactable physician. A 76-year-old male patient received 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: 59267-1000-1) intramuscular at left arm on 02Feb2021 at 11:00AM at a single dose for COVID-19 immunization. Medical history included closed fracture of patella, coronary atherosclerosis, essential hypertension, malignant neoplasm of prostate, and known allergies: acetominophen, doxycycline, oxycodone-acetominophen, oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: 59267-1000-1) intramuscularly at left arm on 12Jan2021 at 12:00PM for COVID-19 immunization. Other medications in two weeks included omeprazole (PRILOSEC, strength: 20 mg), CPD losartan potassium (COZAAR, 25 mg, tablet), simvastatin (strength: 20 mg, tabs), hydrochlorothiazide (strength: 25 mg, tabs). No other vaccine in four weeks. Facility type vaccine was at Doctor's office/urgent care. Adverse events were reported as follows: 20min after getting the 2nd dose, the patient became dizzy and nauseous. 20 min after that the patient developed left arm weakness and numbness and tingling of his left fingers. When trying to get out of his car, he lost balance and fell. He had no loss of consciousness or head trauma. He had progressively worsening left arm and left leg weakness. Adverse event start date was reported on 02Feb2021 at 11:30AM. AE resulted in Emergency room/department or urgent care, hospitalization for 3 days. Treatment received for AE included baclofen and methylprednisolone. The outcome of events was not recovered. No covid prior vaccination. Covid tested post vaccination included Nasal Swab (NAAT) on 02Feb2021 was negative.; 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: PRILOSEC [OMEPRAZOLE]; COZAAR; SIMVASTATIN; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1037876
Sex: F
Age:
State: AZ

Vax Date:
Onset Date: 07/01/2020
Rec V Date: 02/18/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Hospitalized in Jul2020 for this with double pneumonia; Hospitalized in Jul2020 for this with double pneumonia; left lung collapsed; for another chest X-ray to see the damage that COVID has done; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient (age at vaccination was reported as "in her 50s" received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date were not reported) and pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (Manufacturer unknown, lot number and expiration date were not reported); both via unspecified routes of administration on unspecified dates at a single dose for immunization. Medical history included pneumonia for 7 times. Family history includes father has heart disease; has a defibrillator; pacemaker and celiac disease. Cancer runs in her family. All of her sisters have had breast cancer, all of her cousins have had breast cancer, all 3 of her aunts died of breast cancer; and another aunt died of leukemia myeloma acute. It was reported that the patient was hospitalized in Jul2020 for double pneumonia, left lung collapsed. Because had double pneumonia and collapsed lung she has to see a pulmonologist for another chest X-ray to see the damage that COVID has done (pending clarification). It was mentioned that the patient had pneumonia like 7 times in the past so she is susceptible. Because of this history she has gotten the pneumonia vaccine and Prevnar 13 vaccine. Prevnar 13 when she was too young, in her 50s like 4-5 years ago because had pneumonia so many times. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1037877
Sex: M
Age:
State: TN

Vax Date: 01/22/2021
Onset Date: 02/02/2021
Rec V Date: 02/18/2021
Hospital: Y

Lab Data: Test Date: 2021; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Mild leaky aorta; Test Date: 20210202; Test Name: COVID-19 Test; Test Result: Positive ; Test Date: 2021; Test Name: Weight; Result Unstructured Data: Test Result:170-175 lbs

Allergies:

Symptoms: fell and broke his hip; fell and broke his hip; tested positive for COVID-19; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as Pfizer COVID-19 vaccine, lot EL1283, expiry date 30Apr2021), intramuscular in right arm on 22Jan2021 10:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included ongoing Parkinson's disease diagnosed in Jan 2018 and the Neurologist said that the patient probably had it for 6-8 years; ongoing hypertension (its been years); had cardiac and thyroid disorder. The patient was on unspecified medication for his thyroid. The patient fell and broke his hip on 02Feb2021 08:30 and was hospitalized. It was reported that he will have a surgery. The patient underwent laboratory test Sars-cov-2 test: positive on 02Feb2021, weight: 170-175 lbs on unknown date. He also had an echocardiogram a couple of weeks ago (2021) because he was seeing a new heart doctor. The doctor did say that he had a mild leaky aorta and will continue just the medication he was on. He was scheduled to receive the second vaccine on 12Feb2021. The outcome of events was unknown. No further details were provided or obtained.

Other Meds:

Current Illness: Blood pressure high; Parkinson's disease

Date Died: 01/03/2021

ID: 1037878
Sex: M
Age:
State: OH

Vax Date: 12/22/2020
Onset Date: 12/30/2020
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 20201230; Test Name: pulse; Result Unstructured Data: Test Result:low; Test Date: 20210103; Test Name: O2; Result Unstructured Data: Test Result:increased over time; Test Date: 20201221; Test Name: Covid; Result Unstructured Data: Test Result:Positive (+)

Allergies:

Symptoms: Is patient deceased: Yes; Low pulse; This is a spontaneous report from two contactable nurses reporting for a patient. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0140 expiration date Mar2021) intramuscular on 22Dec2020 at 10:30 at single dose in right arm for COVID-19 immunisation. The patient was vaccinated at Nursing Home. Patient age at time of vaccination was 70 years. Patient's Medical History included ongoing Type 2 Diabetes Mellitus Without Complication onset date: admission 22Oct2020, ongoing morbid obesity due to excess calories onset date: admission 22Oct2020, cardiac disorder, essential hypertension, hypertension, schizophrenia, hyperlipidemia, benign prostatic hyperplasia (BPH), Gastrooesophageal reflux disease (GERD), depression, hypothyroid, epilepsy, pain, dry eyes, anxiety, restlessness, 17Jan2020 Slid out of chair to floor, no injury, on 27Jan2020, 28Jan2020, 29Jan2020 diarrhea noted. Concomitant medications included acetylsalicylic acid (ASPIRIN EC) for Cardiac Health, atenolol (ATENOLOL) for Essential Hypertension, atorvastatin calcium (ATORVASTATIN CALCIUM) for hyperlipidemia, finasteride (FINASTERIDE) for benign prostatic hyperplasia, tamsulosin hydrochloride (FLOMAX) benign prostatic hyperplasia, insulin glargine (LANTUS) for diabetes mellitus, lithium carbonate (LITHIUM CARBONATE) for Schizophrenia, losartan potassium (LOSARTAN POTASSIUM) for hypertension, lurasidone hydrochloride (LURASIDONE HYDROCHLORIDE) for Schizophrenia, omeprazole (OMEPRAZOLE) for gastrooesophageal reflux disease, sertraline hcl (SERTRALINE HCL) for depression, levothyroxine sodium (SYNTHROID) for hypothyroid, ergocalciferol (VIT D) for supplement, haloperidol (HALOPERIDOL) for Schizophrenia, levetiracetam (KEPPRA) for epilepsy, paracetamol (TYLENOL EXTRA-STRENGTH) for pain, propylene glycol (ARTIFICIAL TEARS) for dry eyes, lorazepam (ATIVAN) for a anxiety or restlessness. As antipyretic use was reported Tylenol ES (500 mg) Tab, 2 Tabs by Mouth Routine use three times a day given at time of vaccination and after. It was reported the patient was Covid+. He was tested on 21Dec2020 and was not admitted to hospital. Event Onset Date was reported as 24Dec2020 (clarification pending). On 30Dec2020 the patient was started on O2 at 2L for low pulse. O2 was increased over time to eventually O2 at 8L on 03Jan2021. Morphine Sulfate was started on 03Jan2021 at 5 mg sl/by mouth every 2 hours as needed for pain or airhunger. The patient deceased on 03Jan2021. The cause of death was unknown. It was not reported if an autopsy was performed. The AEs did not require a visit to Emergency Room or Physician Office. Outcome of Low pulse was unknown.; Sender's Comments: Based on the information available the events Death (unknown cause) and Heart rate decreased are attributed to patient's multiple underlying medical conditions including Type 2 Diabetes Mellitus, morbid obesity, cardiac disorder, hypertension, epilepsy etc. However, based solely on a vaccine-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the above mentioned events cannot be completely excluded. The case will be reevaluated should additional information, including the cause of death, 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.; Reported Cause(s) of Death: Is patient deceased: Yes

Other Meds: ASPIRIN EC; ATENOLOL; ATORVASTATIN CALCIUM; FINASTERIDE; FLOMAX [TAMSULOSIN HYDROCHLORIDE]; LANTUS; LITHIUM CARBONATE; LOSARTAN POTASSIUM; LURASIDONE HYDROCHLORIDE; OMEPRAZOLE; SERTRALINE HCL; SYNTHROID; VIT D; HALOPERIDOL; KEPPRA; TYLENOL

Current Illness: Morbid obesity (Onset Date: Admission 22Oct2020); Type 2 diabetes mellitus (Onset Date: Admission 22Oct2020)

ID: 1037879
Sex: F
Age:
State: WA

Vax Date: 01/24/2021
Onset Date: 01/25/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 20210125; Test Name: Temperature; Result Unstructured Data: Test Result:100.5; Test Date: 20210126; Test Name: Temperature; Result Unstructured Data: Test Result:99.5

Allergies:

Symptoms: The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperature; Difficulty remembering things; Vomiting; Headache 10/10; developed a red area below injection site/The site got worse through Thursday and was red, hot; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in right deltoid on 24Jan2021 at a single dose for prevention (COVID-19 immunization). Medical history included Low immunoglobulin/compromised immune status/Low immunoglobulin diagnosed 8 years ago, hereditary angioedema from 2010, asthma diagnosed in her 20's, Allergic to Thermarisol, diagnosed allergies, respiratory illness, and endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (LOT number: EJ1686) in right deltoid on 03Jan2021 for covid-19 immunization, and flu shot on Sep2020 without adverse event. She got second injection on 24Jan2021. On 25Jan2021, she woke up with 100.5 degrees temperature and could not stop vomiting. She had to go to the ER. They gave her Zofran, IV and also Toradol because she had a number 10 headache. She continued with low grade temperature throughout week from 99.5-100.5 degrees Fahrenheit, and by Tuesday morning, she developed a red area below injection site. By Thursday, there was a red area growth to 13 cm x 15.5 cm on the injection site. She could not remember her email address and said her brain was not thinking. This started after the vaccine that she began having difficulty remember things. She never had a headache that bad. It improved but she has a lingering headache still. She continued to have a temperature from Monday to Saturday. Currently, she does not have an elevated temperature. Difficulty remembering things was reported as just irritating, but significant. The site got worse through Thursday and was red, hot and ended up measuring 13 cm x 15.5 cm. Regarding weakness, she could walk but medics had to help support from her seat to the ambulance. The outcome of the events red and hot injection site was not recovered; the outcome of the events vomiting, headache, weakness was recovering. The outcome of difficulty remembering things was unknown. The outcome of high temperature was recovered on an unknown date. The events was assessed as medically significant.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and the use of BNT162B2 cannot be excluded. The case will be assessed further upon receipt of 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 RAs, Ethics Committees, and investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1037880
Sex: M
Age:
State:

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 20210204; Test Name: Body temperature; Result Unstructured Data: Test Result:100.8; Comments: Fever of 100.8, chills

Allergies:

Symptoms: delirium; Fever of 100.8; chills; flushed; overall soreness; deltoid pain; This is a spontaneous report from a non-contactable consumer. A 50-year-old male patient received BNT162B2 (lot# unknown) on 03Feb2021 01:30 PM at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient experienced Fever of 100.8, chills, flushed, overall soreness, delirium, and deltoid pain on 04Feb2021 04:00 AM with outcome was Recovering. 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:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm