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: 0923238
Sex: F
Age: 49
State: IA

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies: No

Symptoms: Sensation of lightheadedness, difficulty focusing , nausea and shortness of breath

Other Meds: Metformin, Escitalopram, Buproprion, Vitamin D, Rosuvastatin, Adderall

Current Illness: No

ID: 0923239
Sex: F
Age: 59
State: IN

Vax Date: 01/04/2021
Onset Date: 01/05/2021
Rec V Date: 01/06/2021
Hospital:

Lab Data: None

Allergies: Sulfa medication, dairy products

Symptoms: Fever between 99.6-100 degrees fahrenheit for 24 hours. Weakness and mild nausea.

Other Meds: Estrogen patch, vitamin D, Calcium, Niacin

Current Illness: None

ID: 0923240
Sex: F
Age: 41
State: ID

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data: NA

Allergies:

Symptoms: Fever, Chills, and fatigue

Other Meds:

Current Illness:

ID: 0923241
Sex: F
Age: 46
State: IN

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/06/2021
Hospital:

Lab Data: None

Allergies: Nka

Symptoms: Extreme fatigue and nausea.

Other Meds: Trazadone 25mg q hs Lisinopril 10 mg qd Procardia 30mg qd

Current Illness: None

ID: 0923242
Sex: F
Age: 49
State: NY

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies: nka

Symptoms: lightheadedness

Other Meds:

Current Illness:

ID: 0923243
Sex: F
Age: 76
State: FL

Vax Date: 12/30/2020
Onset Date: 01/05/2021
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies: Lexapro, Wellbutrin, Cipro

Symptoms: On the sixth day after the vaccination at the site of the vaccination on the left upper arm I experienced slight swelling, redness, and itching.

Other Meds: Carbidopa/Levodopa, amlodipine besylate, Synthroid, Vitamin B12, Vitamin D3

Current Illness: None

ID: 0923244
Sex: U
Age:
State:

Vax Date: 12/18/2020
Onset Date: 12/27/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data: Test Date: 20201227; Test Name: Covid 19 virus; Result Unstructured Data: Test Result:positive

Allergies:

Symptoms: tested positive for the Covid 19; tested positive for the Covid 19; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 18Dec2020 as the first single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for the COVID 19 on 27Dec2020. The patient underwent lab tests and procedures which included a test for Covid 19 virus, which was positive on 27Dec2020. The outcome of tested positive for the COVID 19 was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.

Other Meds:

Current Illness:

ID: 0923245
Sex: M
Age: 45
State: TX

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/06/2021
Hospital:

Lab Data: No adverse reactions noted

Allergies:

Symptoms: 2nd dose of vaccine given 2 early. 1st dose given on 12/23/2020 and 2nd dose given 13 days later.

Other Meds:

Current Illness:

ID: 0923246
Sex: F
Age:
State: LA

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data: Test Date: 20201225; Test Name: Blood presure; Result Unstructured Data: Test Result:high; Test Date: 20201225; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20201225; Test Name: heart rate; Result Unstructured Data: Test Result:High

Allergies:

Symptoms: coughing; Itching; chest tightening; large whelps all over body, face, eyes; high blood pressure and heart rate noted; high blood pressure and heart rate noted; 18 hrs after vaccine mild rash on back and arms and mild sob; 18 hrs after vaccine mild rash on back and arms and mild sob; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9231), via an unspecified route of administration in the right arm on 23Dec2020 at 19:30 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, kidney stones, and gastrooesophageal reflux disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethynylestradiol/norgestrel (OGESTREL-28), cetirizine hydrochloride (ZYRTEC), and cefdinir (OMNICEF). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took nicotinic acid (NIACIN) on unknown dates for an unknown indication and experienced drug allergy in the form of mild flushing. On 24Dec2020 at 13:30, 18 hours after the vaccine, the patient experienced mild rash on back and arms and mild shortness of breath (SOB). On 25Dec2020, the next day, the patient had a severe rash with large whelps all over body, face, eyes. She had extreme SOB, chest tightening, coughing and itching. The patient went to the hospital emergency room and high blood pressure and heart rate were noted. On 25Dec2020, the patient had a nasal swab done for COVID and it was negative. The patient was treated for the events with IV methyprednisolone (MANUFACTURER UNKNOWN), IV famotidine (MANUFACTURER UNKNOWN) and hydroxyzine pamoate (VISTARIL). The clinical outcomes of the rash, SOB, large whelps, chest tightening, couching, itching, high blood pressure, and high heart rate, were recovered in Dec2020.

Other Meds: OGESTREL-28; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; OMNICEF [CEFDINIR]

Current Illness:

ID: 0923247
Sex: F
Age: 41
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/06/2021
Hospital:

Lab Data: None

Allergies: Eggs-edible

Symptoms: 1/4/21-Headache with aura started around noon progressing into the evening with extreme muscle and joint pain. Mostly from the calf to both feet with swelling. Fever started next day 1/5/21 till current 1/6/21. Highest temp 102 degrees. Painful to walk or stand. Nausea- no vomiting. Swollen shoulder at the injection site.

Other Meds: Carvedilol 25mg

Current Illness: Migraine in December 2020

ID: 0923248
Sex: M
Age:
State: DE

Vax Date: 12/23/2020
Onset Date: 12/01/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nausea; Ache; Chills; Fever; chest tightness congestion; woke up sweating; cough; fatigue; This is a spontaneous report from a Pfizer-sponsored program a contactable consumer. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK5730), via an unspecified route of administration on 23Dec2020 at 10:00 as single dose for COVID-19 immunization. There was no medical history and no concomitant medications. The patient experienced ache on 25Dec2020, at 08:30 with outcome of not recovered; chills on 25Dec2020, at 08:30 with outcome of not recovered; fever on 25Dec2020 with outcome of recovering; chest tightness congestion on 25Dec2020 with outcome of not recovered; nausea on 27Dec2020 with outcome of recovering; woke up sweating on 25Dec2020 with outcome of not recovered; cough on Dec2020 with outcome of unknown; fatigue on Dec2020 with outcome of unknown. Therapeutic measures were taken as a result of ache, chills, fever, chest tightness congestion, nausea, woke up sweating, cough and fatigue. Details were as follows: Patient received the vaccine. Then he noticed on 25Dec2020 at 0830AM body aches and chills. Then later a chest tightness. Then the next day 26Dec2020 it got worse and he noticed fever. He didn't take his actual temperature. He did notice in the middle of the night he woke up sweating. He has not had a COVID test. He has not been treated, but has taken acetaminophen (TYLENOL) and ibuprofen and nasal spray. He also mentioned that he experienced chest congestion and one day of nausea. The patient added that the aches were the worst in the night and at first waking up in the morning. With regard to fever, it got a little better but it seemed to depend on temperature, first he was cold and then sweating. The fever seemed like it improved.

Other Meds:

Current Illness:

ID: 0923249
Sex: F
Age: 62
State:

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Intense fatigue, intense muscle and joint pain. No treatment given except for bed rest. Symptoms mostly gone by the next day (they lasted around 12-20) hours).

Other Meds:

Current Illness:

ID: 0923250
Sex: F
Age:
State: CA

Vax Date: 12/25/2020
Onset Date: 12/25/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Severe left side knee and shoulder pain; Could barely walk; could not lift left arm above 90 degrees; The arm pain was not your typical injection site pain from a flu shot; This is a spontaneous report from contactable healthcare professional, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685), intramuscular in the left arm on 25Dec2020 at 09:00 as a single dose for COVID-19 immunization. Medical history included asthma, hypertension, arthritis, and sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D) and losartan (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Dec2020 at 21:00, the patient experienced severe left side knee and shoulder pain, could barely walk, and could not lift left arm above 90 degrees. The patient stated that the arm pain was not your typical injection site pain from a flu shot. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for the events. The clinical outcomes of severe left side knee and shoulder pain, could barely walk, could not lift left arm above 90 degrees, and arm pain was not your typical injection site pain of flu shot, were recovering. The events were all reported as non-serious. However, it was also reported that the duration of hospitalization was 1 (not further specified).

Other Meds: VITAMIN D [COLECALCIFEROL];

Current Illness:

ID: 0923251
Sex: F
Age: 49
State: CA

Vax Date: 12/24/2020
Onset Date: 12/24/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data: Transported to Emergency Room for evaluation and released

Allergies: ? Aspirin Hives ? Contrast Dye Itching ? Ibuprofen Rash ? Ketorolac Tromethamine Hives ? Pcn [Penicillins] Rash

Symptoms: periorbital swelling ;swelling of lips tightening of lips ; BP elevated remained elevated more than 15mins Transported to Emergency Room for evaluation Received Benedryl 50 mg PO

Other Meds: Calcium MVI Claritin Omega 3 MVI Glucosamine

Current Illness:

ID: 0923252
Sex: F
Age:
State: VA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Pain at injection site; Chills; Fever; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730 via an unspecified route of administration, in the right arm, from 28Dec2020 07:30 at a single dose, for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included estradiol (ESTROGEN) cream. On 28Dec2020 22:45, the patient experienced pain at injection site, chills and fever. The outcome of events was reported as recovering. No follow up attempts are needed. No further information is expected. Information on the batch/lot number has been obtained.

Other Meds: ESTROGEN

Current Illness:

ID: 0923253
Sex: F
Age: 54
State: OH

Vax Date: 01/04/2021
Onset Date: 01/06/2021
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies: PCN- white injection causes vomiting myacins-rash sulfa (causes facial swelling bactrim)

Symptoms: Swelling and pain under left arm in the axilla anterior area and left ear drum.

Other Meds: Tylenol xtra strenght Flexaril Aleve Allegra multi vitamin benadryl cold and flu

Current Illness: Sinus infection diagnosed 12-5-20

ID: 0923254
Sex: F
Age:
State: MI

Vax Date: 12/20/2020
Onset Date: 12/20/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data: Test Date: 20201220; Test Name: fever; Result Unstructured Data: Test Result:Low grade/99.8 at highest; Comments: Low grade fever 99.8 at highest; Test Date: 20201223; Test Name: Covid test/Nasal Swab; Test Result: Negative

Allergies:

Symptoms: Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; This is a spontaneous report from a contactable nurse. A 56-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKS730), intramuscularly on 20Dec2020 08:45AM at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Patient was diagnosed with COVID-19 prior to vaccination. Known allergies included Penicillin. Concomitant medication included levothyroxine, pravastatin, buspirone, zinc, ascorbic acid (VITAMIN C), tocopherol (VITAMIN E), vitamin d3, vitamin b complex (B COMPLEX), calcium citrate, chondroitin sulfate, glucosamine sulfate, methylsulfonylmethane (GLUCOSAMINE CHONDROITIN & MSM). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash on 20Dec2020. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The patient underwent Covid test type post vaccination - Nasal Swab: Negative on 23Dec2020.

Other Meds: ; ; ; ; VITAMIN C; VITAMIN E; VITAMIN D3; B COMPLEX; ; GLUCOSAMINE CHONDROITIN & MSM

Current Illness:

ID: 0923255
Sex: F
Age:
State:

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies:

Symptoms: drooping on one side of the face/ eye hurts to open and hurts to close it; Her eyes are droopy; "my eye is hurting so bad", it hurts to open and hurts to close it/pain in the eyes; Face is tender to the touch and hurts on that one side; Swelling of her left side of her face that hasn't gone down/swelling and drooping on one side of the face; This is a spontaneous report from a contactable nurse (patient). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller asking if pain in the eyes and swelling and drooping on one side of the face a side effect of the vaccine. Patient received the Covid vaccine on 23Dec2020 and noticed the next day (24Dec2020) swelling of her left side of her face that hasn't gone down. Her face is tender to the touch and hurts on that one side. Her eyes are droopy, "my eye is hurting so bad", it hurts to open and hurts to close it. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset eye hurts to open and hurts to close/ eyes droopy cannot be excluded, considering the plausible temporal relationship. 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: 0923256
Sex: M
Age:
State: TX

Vax Date: 12/21/2020
Onset Date: 12/27/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data: Test Date: 20201227; Test Name: Fever; Result Unstructured Data: Test Result:98.9; Test Date: 20201228; Test Name: Fever; Result Unstructured Data: Test Result:100.0; Test Name: weight; Result Unstructured Data: Test Result:315

Allergies:

Symptoms: He has a 100.0 fever; Cough; Little bit of congestion in his chest; Body ache; Sore shoulder; Joint pain; Muscle pain; This is a spontaneous report from a contactable consumer. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), intramuscular on 21Dec2020 as single dose for covid-19 immunization. There was no medical history and no concomitant medications. The patient experienced body ache on 27Dec2020 with outcome of unknown; sore shoulder on 27Dec2020 with outcome of unknown; joint pain on 27Dec2020 with outcome of unknown; muscle pain on 27Dec2020 with outcome of unknown; he has a 100.0 fever on 28Dec2020 with outcome of unknown; cough on 28Dec2020 with outcome of unknown; little bit of congestion in his chest on 28Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included fever at 98.9 on 27Dec2020, and 100.0 on 28Dec2020, weight: 315 on an unspecified date. Details were as follows: patient has been experiencing side effects. Per the reporter (wife to patient), he got a little under the weather, body ached kind of like sore shoulder, like joint pain, muscle pain. He did not have a headache. First he had a fever at 98.9, it was okay but this morning as he woke up, it was 100.0 fever. When he woke up, he felt better because he rested, but he woke up with a cough and a little bit of congestion in his chest. Therapeutic measures were taken as a result of the events, and included acetaminophen (TYLENOL). The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 0923257
Sex: F
Age:
State: IN

Vax Date: 12/19/2020
Onset Date: 12/28/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data: Test Date: 20201228; Test Name: COVID-19; Result Unstructured Data: Test Result:COVID-19 virus test positive

Allergies:

Symptoms: received the COVID-19 vaccine on 19Dec2020 and then contracted COVID-19/positive COVID-19 test after receiving COVID-19 vaccine; received the COVID-19 vaccine on 19Dec2020 and then contracted COVID-19/positive COVID-19 test after receiving COVID-19 vaccine; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect via a contactable consumer. A 22-year-old female patient receive 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 in left arm/deltoid on 19Dec2020 at 0.3 mL, single for Covid-19 immunisation (as protection). Medical history included ulcerative colitis. The patient's concomitant medications were not reported. On 28Dec2020, the patient was positive for COVID-19 test after receiving COVID-19 vaccine. She informed she contracted COVID-19 due to an exposure from a co-worker. The outcome of events was not recovered. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0923258
Sex: F
Age: 45
State: CA

Vax Date: 12/24/2020
Onset Date: 12/25/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies: nkda

Symptoms: next day with headache, nausea, dizziness, tachycardia up to 170 for about 30 minutes. symptoms started the morning after the vaccine about 24 hours later and then resolved within that next day.

Other Meds:

Current Illness:

ID: 0923259
Sex: F
Age:
State: CA

Vax Date: 12/19/2020
Onset Date: 12/01/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data: Test Date: 202012; Test Name: COVID-19 test; Test Result: Negative

Allergies:

Symptoms: mild asthma attack; moderate dyspnea; chest pressure; a 4-5 cm area of induration; mild erythema in her left deltoid area; This is a spontaneous report from a contactable physician. A non-pregnant 37-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: Unknown), intramuscularly in the left arm on 19Dec2020 at 37-years-old at a SINGLE DOSE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included intermittent asthma from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced the following events and outcomes: mild asthma attack on 21Dec2020 with outcome of recovering, moderate dyspnea on 21Dec2020 with outcome of recovering, chest pressure on 21Dec2020 with outcome of recovering, a 4-5 cm area of induration in Dec2020 with outcome of unknown, mild erythema in her left deltoid area in Dec2020 with outcome of unknown. The patient had intermittent asthma with no attacks in the past six years. Two days after the vaccination, she had a mild asthma attack when she was walking up stairs. For the past two days, she has had multiple asthma attacks, with moderate dyspnea and chest pressure present for most of the day. The patient's symptoms have been improving with her as needed (PRN) salbutamol (ALBUTEROL) inhaler. The physician saw the patient in a telemedicine visit and found her to have an asthma exacerbation; therefore, prednisone was prescribed. The patient had no symptoms of viral infection and reported testing negative for COVID-19 after the onset of her asthma symptoms. The physician suspected her asthma exacerbation to have been caused by the vaccine because she had been symptom-free in recent years and she has not had a new exposure other than the vaccine. In addition to her respiratory symptoms, the patient had a 4-5 cm area of induration and mild erythema in her left deltoid area; this appeared about 1 week after she received the vaccine. Therapeutic measures were taken as a result of mild asthma attack, moderate dyspnea, chest pressure. The patient, since the vaccination, had been tested for COVID-19. Prior to the vaccination, the patient was not diagnosed with COVID-19. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0923260
Sex: F
Age:
State: IN

Vax Date: 11/01/2018
Onset Date: 11/01/2018
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies:

Symptoms: fatigue; She could not get in out of her chair by herself, bathe, dress, or do any activities of daily living because the pain was so bad; the patient was administered with a first dose of PREVNAR 13 and a year later she received a second dose; pain in the administration site; She said that she had severe intense pain in her arm; she had large lump occur at the injection site about the size of egg; She could not lift her arm; This is a spontaneous report from a contactable consumer (patient) and contactable physician received via Medical Information Team. A 66-year-old female patient received two doses of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), first dose on Nov2017 and second dose on Nov2018, both intramuscular at single dose for immunization. The patient medical history included paraplegia (T10-T11 ) from Sep1969 and ongoing, ongoing high blood pressure (diagnosed between 2005-2010), ongoing acid reflux (esophageal), ongoing Raynaud's syndrome (diagnosed in the 1980's), ongoing low grade bladder infection (the patient had a indwelling catheter), the patient has been diagnosed with limited scleroderma in 2010 unknown if ongoing (the patient said that she does not show any symptoms). There were no concomitant medications. It was reported that the patient was administered with a first dose of PREVNAR 13 and a year later she received a second dose, on Nov2018 after second dose administered the patient experienced "a very bad reaction to PREVNAR 13", the patient reported "pain in the administration site, she had a large lump occur at the injection site about the size of egg. It traveled down her arm below the elbow. It started after receiving the injection and it was dissipated. The pain started subsiding late. She had severe intense pain in her arm. She could not lift her arm and could not reach across the sink to turn the faucet on. It was very debilitating. She could not get in out of her chair by herself, bathe, dress, or do any activities of daily living because the pain was so bad. She was really tired and after reading the side effects, she assumed it was part of the fatigue that comes with the shot. She stated that she does not remember any chills or fever or anything like that". The patient outcome of large lump and pain was recovered on an unspecified date, and the outcome of fatigue was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.

Other Meds:

Current Illness: Acid reflux (esophageal); Bladder infection (Caller has a indwelling catheter.); Blood pressure high (Diagnosed between 2005-2010); Paraplegia (T10-T11.); Raynaud's syndrome (Diagnosed in the 1980's)

ID: 0923261
Sex: F
Age: 46
State: TX

Vax Date: 01/03/2021
Onset Date: 01/04/2021
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies: Aspirin,grass,dust,polen,pet hair.

Symptoms: Dizziness,Weakness, very low and then High blood pressure.(Uncontrollably)

Other Meds: Metformin500mg twice daily,400mg ibuprofen once,Metoprolol 25mg er once daily,Montelukast 10mg one daily,Breo fluticasone,one inhalation daily,Albuterol sulfate inhalation aerosol one puff every 4 hours or as needed,multivatimins.

Current Illness: None,only The preexistents Asthma,Diabetes and High blood pressure.

ID: 0923262
Sex: F
Age: 44
State: PA

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

Lab Data: 1/2/2020 Chest X Ray, EKG - normal, no findings

Allergies: darvocet vicodin latex percocet venofer

Symptoms: After left the clinic - 35 minutes post injection felt lightheaded, warm and some chest pressure. Clinic had ended. Sent to the ED for evaluation. EKG and Chest xray done - within normal limits. Discharged from the ED with a discharge note of likely vasovagal response

Other Meds: no

Current Illness: unknown

ID: 0923263
Sex: F
Age:
State: LA

Vax Date: 12/16/2020
Onset Date: 12/22/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data: Test Date: 20201222; Test Name: Body temperature; Result Unstructured Data: Test Result:100 Fahrenheit; Test Date: 202012; Test Name: COVID-19 tests; Test Result: Negative ; Test Date: 202012; Test Name: COVID-19 tests; Test Result: Negative

Allergies:

Symptoms: Fever of 100 degrees for one week; This is a spontaneous report from contactable healthcare professional, the patient. A 39-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 16Dec2020 at 09:00 (reported as at the age of 39-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Dec2020, the patient experienced fever of 100 degrees Fahrenheit for one week. The patient went to the doctor for the event but was not given any treatment. The patient was tested twice for COVID-19 during the week of the fever in Dec2020 and both time the results were negative. The clinical outcome of fever of 100 degrees Fahrenheit for one week was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0923264
Sex: M
Age: 43
State: CA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data: none

Allergies: Penicillin

Symptoms: Sudden fatigue lasting 3 hours then gradually went away.

Other Meds: Balsalazide Atorvastatin

Current Illness:

ID: 0923265
Sex: F
Age:
State: OK

Vax Date: 12/18/2020
Onset Date: 12/19/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies:

Symptoms: on/off mild headache; extreme fatigue; swollen, very tender pea size lymph node by collarbone nearest to the injection site; This is a spontaneous report from a contactable nurse (patient herself). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) via an unspecified route of administration (arm left), on 18Dec2020 at 10:45, at a single dose, for COVID-19 immunization. Patient is not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included attention deficit hyperactivity disorder (ADHD), anxiety, chronic back pain, and allergies to penicillin. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), baclofen, oxymetazoline hydrochloride (CLARITIN ALLERGIC), and sertraline hydrochloride (ZOLOFT). On 19Dec2020, 24hrs post vaccination, the patient had a swollen, very tender pea size lymph node by collarbone nearest to the injection site, and an on/off mild headache. 48hrs post vaccination, patient had extreme fatigue and on/off headache, still had swollen lymph nodes. The patient did not receive treatment for the events. Outcome of the event swollen lymph nodes was not recovered, while for the other events was unknown. Since the vaccination, has the patient has not been tested for COVID-19.

Other Meds: JUNEL FE; ADDERALL; ; CLARITIN ALLERGIC; ZOLOFT

Current Illness:

ID: 0923266
Sex: M
Age:
State: FL

Vax Date: 12/17/2020
Onset Date: 12/28/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data: Test Date: 20201228; Test Name: Covid; Test Result: Positive

Allergies:

Symptoms: received his first dose of the vaccine and tested positive for Covid yesterday; received his first dose of the vaccine and tested positive for Covid yesterday; This is a spontaneous report from a contactable healthcare professional. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received his first dose of the vaccine on 17Dec2020 and tested positive for Covid yesterday (28Dec2020). He is scheduled to have his second dose in January. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role BNT162B2 vaccine cannot be completely excluded for event "tested positive for COVID".

Other Meds:

Current Illness:

ID: 0923267
Sex: F
Age: 29
State: FL

Vax Date: 12/30/2020
Onset Date: 01/05/2021
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies: IODINE

Symptoms: NAUSEA THE SAME DAY AND DAY AFTER THE INJECTION. A WEEK LATER, I AM EXPERIENCE SWOLLEN, HOT, RED AND ITCHY AT THE INJECTION SITE.

Other Meds: GABAPENTIN

Current Illness:

ID: 0923268
Sex: F
Age:
State: DE

Vax Date: 12/21/2020
Onset Date: 12/01/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies:

Symptoms: headache; After she got the vaccine, she was exposed to someone who had Covid; This is a spontaneous report via a Pfizer Sponsored Program, Pfizer First Connect from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on the right arm 21Dec2020 at single dose for Covid prevention. Medical history included blood pressure and can't see to read without her glasses. Concomitant medication included amlodipine. The patient stated, "she got the Covid vaccine on 21Dec2020 and had a headache for 1-2 days. After she got the vaccine, she was exposed to someone who had Covid, and wants to know if she can still get the second dose. She has had no symptoms after being exposed (Dec2020) but is about to be tested just in case she gets the virus. Her co-worker was positive and they were all in the breakroom without a mask. A couple other nurses are also concerned and don't know whether to get the second shot. They test at the hospital every Wednesday and wanted to know if she still can be tested before she gets the second shot. She had slight headaches on the 22nd, so she took some EXCEDRIN and it went away". The outcome of headache was recovered on 22Dec2020 and other event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518688 same reporter/drug, similar event, different patient

Other Meds:

Current Illness:

ID: 0923269
Sex: M
Age:
State:

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data: Test Date: 202012; Test Name: blood pressure; Result Unstructured Data: Test Result:high; Test Date: 202012; Test Name: heart rate; Result Unstructured Data: Test Result:120 or so; Test Date: 202012; Test Name: vital signs; Result Unstructured Data: Test Result:normal

Allergies:

Symptoms: he was flushed; light headed; tingling around mouth; 3-4 minutes after my blood pressure was high; heart rate was 120 or so; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received the first dose of BNT162B2 (lot number unknonwn), via an unspecified route of administration, in Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he received the first dose of the vaccine 11 days ago in Dec2020 and had a reaction. He stated probably 3 minutes after when he was getting ready to leave the area he was flushed and light headed and tingling around mouth. The staff in the area sat him down and 3-4 minutes after his blood pressure was high and heart rate was 120 or so. Those symptoms lasted about 10 minutes and went away on their own and he did not get epi pen or Benadryl. The patient's vital signs were normal after an hour or so and there was no intervention at any point and have had no issues subsequently. He stated that they said it wasn't technically an anaphylactic reaction but that it is hard to put a name to this description. The outcome of the events was recovered in Dec2020. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0923270
Sex: F
Age: 32
State: IN

Vax Date: 01/04/2021
Onset Date: 01/05/2021
Rec V Date: 01/06/2021
Hospital:

Lab Data: N/A

Allergies: N/A

Symptoms: Nausea and chills starting about 12 hours post injection, lasting a few hours. Fatigue and muscle fatigue the day after injection lasting into the second day after injection (today).

Other Meds: Duloxetine HCL DR 30 MG CAP

Current Illness: N/A

ID: 0923271
Sex: F
Age:
State:

Vax Date: 12/22/2020
Onset Date: 12/01/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data: Test Date: 202012; Test Name: tested; COVID; Result Unstructured Data: Test Result:positive

Allergies:

Symptoms: tested positive for COVID after the first dose; tested positive for COVID after the first dose; This is a spontaneous report from a contactable Pharmacist reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via an unspecified route of administration on 22Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient informed that she had the COVID-19 vaccine exactly a week ago (22Dec2020). However, she was tested positive for COVID (Dec2020) after the first dose. The outcome of the events tested positive for COVID after the first dose was unknown. The patient asked if she can take the second dose. Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.

Other Meds:

Current Illness:

ID: 0923272
Sex: M
Age:
State: TX

Vax Date: 12/14/2020
Onset Date: 12/28/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies:

Symptoms: headaches; This is a spontaneous report from a non-contactable nurse practitioner. An adult male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 14Dec2020 at 17:00 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. On 28Dec2020, the patient experienced headaches (non-serious). The clinical course was reported as follows: The patient was a nurse practitioner who received the Pfizer vaccine. The patient reported getting headaches 15 days (as reported) after the first shot. The patient had no idea if the event was related to the vaccination, but he had no history of headaches. The patient took 600mg of ibuprofen (ADVIL) "to try to get the HA." The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was unknown prior to vaccination, if the patient was diagnosed with COVID-19. It was unknown, since the vaccination, if the patient had been tested for COVID-19. Therapeutic measures were taken as a result of headaches. The clinical outcome of the event was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 0923273
Sex: F
Age: 34
State: IN

Vax Date: 01/04/2021
Onset Date: 01/06/2021
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies:

Symptoms: ADR to Moderna Vaccine History of allergic reactions. Took diphenhydramine 25 mg prior to injection. Facial and finger swelling along with redness noted 40 minutes later. Took second dose of diphenhydramine. Was decreasing when patient returned to clinic. Has allergy treatment plan form allergist and felt comfortable going home. Developed metal taste soon after vaccine. Several hours later developed heahache and chills a couple hours later.

Other Meds:

Current Illness:

ID: 0923275
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/06/2021
Hospital:

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

Allergies:

Symptoms: We have a patient that received the 1st vaccine, then 7days later they tested positive for COVID-19.; We have a patient that received the 1st vaccine, then 7days later they tested positive for COVID-19.; This is a spontaneous report from a contactable pharmacist (Pharmacy Intern) via Pizer-sponsored program: A patient of unspecified age and gender received first single dose of BNT162B2 (lot number, and exp date not reported), via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. The patient received the 1st vaccine, then 7days later tested positive for COVID-19 (date unspecified). It was asked if patient needed to wait 90 days to receive the 2nd Vaccine dose. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0923276
Sex: F
Age:
State:

Vax Date: 12/17/2020
Onset Date: 12/26/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data: Test Date: 20201226; Test Name: Covid; Test Result: Positive

Allergies:

Symptoms: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first single dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, lot number and exp date not reported), via an unspecified route of administration on 17Dec2020 for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first Covid vaccine and on 26Dec2020, tested positive for Covid. Patient asked when if it was safe for her to get second dose. Asked if she get it on 21 days or if she had to wait. The outcome of the event was unknown. Information about Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.

Other Meds:

Current Illness:

ID: 0923277
Sex: F
Age: 42
State: AR

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies: PCN and Sulfa

Symptoms: Headache, nausea, diarrhea, nerve-like pain, muscle pain. Took Advil and otc anti-diarrheal. Continues to have nerve pain, headache, and muscle pain. Today she obtained a red hot rash to injection site.

Other Meds: Progesterone

Current Illness: No

ID: 0923278
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/06/2021
Hospital:

Lab Data: Test Name: COVID; Result Unstructured Data: Test Result:had Covid

Allergies:

Symptoms: had covid and also received the Pfizer covid 19 vaccine.; had covid and also received the Pfizer covid 19 vaccine.; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender started received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. They have a patient that meets the criteria to receive product bamlanivimab. The patient had Covid and received the Pfizer covid 19 vaccine. The nurse asked if patient can still get the bamlanivimab after receiving vaccine. The outcome of the events was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, it is unclear if Covid developed after BNT162B2 Pfizer covid 19 vaccine, pending further clarification, at this moment, the Company would handle the reported COVID related to the suspect, BNT162B2, for reporting purpose.

Other Meds:

Current Illness:

ID: 0923279
Sex: M
Age: 26
State: NY

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/06/2021
Hospital:

Lab Data: None

Allergies: NKDA

Symptoms: Hematospermia, with no hematuria, dysuria, or dyspareunia. No recent sex, one female partner, oral sex only. Unlikely to have recent covid or other infection; I've been on vacation (at home, no travel) but did 2 days in non-COVID19 ICU on 1/5 and 1/6. Last intercourse one week ago, with no symptoms. ROS otherwise negative. On self-physical exam, no tenderness of testes, penis, suprapubic region, CVAT. Exam otherwise negative; unable to perform prostate exam on self.

Other Meds: None

Current Illness: None

ID: 0923280
Sex: F
Age:
State: TN

Vax Date: 12/23/2020
Onset Date: 12/27/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies:

Symptoms: hsv-1 outbreak; sore arm redness and bruising at site; sore arm redness and bruising at site; sore arm redness and bruising at site; This is a spontaneous report from a contactable physician. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1204), intramuscular into the left arm on 23Dec2020 at 18:00 as single dose for COVID-19 immunization. Medical history included herpes simplex 1 (HSV1) from an unknown date. The patient's concomitant medications were not reported. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no allergies to medications, food, or other products. On 27Dec2020, patient experienced HSV-1 outbreak and sore arm redness and bruising at site. This was elaborated as 4- 5 days post vaccine, there was marked HSV-1 outbreak, different than typical outbreak and that was not responding to valacyclovir hydrochloride (VALTREX). There was also sore arm redness and bruising at site. The events were not serious. Therapeutic measures were taken as a result of the events as aforementioned (valacyclovir hydrochloride). The outcome of events, HSV-1 outbreak and sore arm redness and bruising at site was not recovered.

Other Meds:

Current Illness:

ID: 0923281
Sex: F
Age: 58
State: IN

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies: Morphine, Sulfa, Flagyl

Symptoms: Swelling deltoid muscle, headache, nausea

Other Meds: Losartan/HCTZ

Current Illness: None

ID: 0923282
Sex: F
Age:
State: MD

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies:

Symptoms: stomach cramping; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), via an unspecified route of administration on 28Dec2020 at 11:45 at 62-years-old at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 28Dec2020, the patient experienced: stomach cramping and diarrhea; which was assessed as non-serious. The clinical course was reported as follows: The patient stated she had the vaccine on 28Dec2020 at 11:45 and "maybe an hour later", her stomach start cramping and then had diarrhea. The patient wanted to know if that was something "to be concerned about." In regard to having any laboratory test, the patient stated, "I went in November sometime for my annual checkup I think it was November" (as reported). When the patient was asked if they received any treatment for the events, the patient stated, "No. I am still at work, I got it today, I haven't taken anything but I was thinking that to just get some "Caper" (as reported) and "gentian soda" (as reported)." The clinical outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 0923283
Sex: F
Age:
State: CA

Vax Date: 12/22/2020
Onset Date: 12/23/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies:

Symptoms: flare of existing autoimmune disease (undifferentiated connective tissue disease (UCTD) with predominant features of systemic sclerosis); flare of existing autoimmune disease (undifferentiated connective tissue disease (UCTD) with predominant features of systemic sclerosis); flare of existing autoimmune disease (undifferentiated connective tissue disease (UCTD) with predominant features of systemic sclerosis); This is a spontaneous report from a contactable physician. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899) intramuscular on 22Dec2020 16:15 (04:15 PM) at a single dose on the left arm as COVID-19 vaccine. Medical history included autoimmune disease (undifferentiated connective tissue disease (UCTD) with predominant features of systemic sclerosis); secondary Raynaud's phenomenon with calcinosis; known allergies to sulfa drugs, pine nuts. Concomitant medications included mycophenolate mofetil (MMF) 1000mg bid (twice a day), hydroxychloroquine sulfate (PLAQUENIL) 300mg qd (once a day), and prednisone 15mg daily (received within 2 weeks of vaccination). The patient had an adverse event (AE) of flare of existing autoimmune disease (undifferentiated connective tissue disease (UCTD) with predominant features of systemic sclerosis) on 23Dec2020 09:00 PM (also reported as flare began about 36-48 hours after vaccine) which required increased daily dose of prednisone (higher dose) up to 80mg total daily dose (80mg daily x3d, then tapered down) (treatment received for AE) and lasted about 4-5 days. The patient was not pregnant at the time of vaccination. She had no other vaccine in four weeks (did not receive other vaccine within four weeks prior to the COVID vaccine). She was not diagnosed with COVID-19 prior to vaccination and did not have Covid tested post vaccination (had not been tested for COVID-19 since the vaccination). The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). The outcome of the events was recovered on Dec2020.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported flare of existing autoimmune disease (undifferentiated connective tissue disease (UCTD) with predominant features of systemic sclerosis) and the administration of BNT162B2, based on the plausible temporal association. 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 agencys, as appropriate.

Other Meds: MMF; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE];

Current Illness:

ID: 0923284
Sex: M
Age: 31
State: WI

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/06/2021
Hospital:

Lab Data: NO FURTHER MEDICAL TESTS OR LABORATORY TESTING REPORTED AT THIS TIME - 1/6/21.

Allergies: UNKNOWN

Symptoms: NO ADVERSE REACTION WITHIN FIRST HOUR OF VACCINE ADMINISTRATION. PT. REPORTS LOSS OF SENSE OF TASTE WITHIN HOURS OF RECEIVING THE VACCINE. PER PT. EMAIL REPORT, "I noticed when I got home yesterday while eating supper I could not TASTE anything. I was eating a really garlicy meal and I kept putting more garlic on it as I couldn?t figure out why I couldn?t taste it. I am still having the same problem today. I am sure it will go away, but you said to let you know of any symptoms."

Other Meds: UNKNOWN

Current Illness: UNKNOWN

ID: 0923285
Sex: F
Age:
State: CA

Vax Date: 12/22/2020
Onset Date: 12/23/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Palpitations; tachycardia; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: Ej1685), via an unspecified route of administration on the left deltoid on 22Dec2020 at SINGLE DOSE for COVID-19 immunization at the hospital. It was reported that prior to vaccination the patient was diagnosed with COVID-19 (unknown date). The patient's concomitant medications were not reported. The patient had palpitations and tachycardia on 23Dec2020 (also reported as second day post vaccine) which resulted to doctor or other healthcare professional office/clinic visit. The patient received unspecified beta blocker as treatment. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 0923286
Sex: M
Age: 47
State: IL

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/06/2021
Hospital:

Lab Data: none

Allergies: Shellfish, Iodine, Morphine, CT contrast, animal dander, rag weed, and seasonal allergies

Symptoms: within 15 minutes of receiving vaccine, developed hives and became itchy, Benadryl was taken by the employee. Declined treatment.

Other Meds: zyrtec daily and Benadryl as needed

Current Illness: none

ID: 0923287
Sex: F
Age:
State:

Vax Date: 12/19/2020
Onset Date: 12/21/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data: Test Date: 202012; Test Name: Covid; Test Result: Positive

Allergies:

Symptoms: developed symptoms/mild/thought the symptoms were from the vaccine but turned out she did test positive for Covid; developed symptoms/mild/thought the symptoms were from the vaccine but turned out she did test positive for Covid; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Dec2020 at a single dose as vaccine. Medical history and concomitant medications were not reported. The patient received the vaccine on 19Dec2020 and 2 days later on 21Dec2020, she developed symptoms. Her symptoms had been mild. She thought the symptoms were from the vaccine but turned out she did test positive for Covid on Dec2020. She inquired what would happen if you get the vaccine and you test positive. She also inquired if her symptoms would be worse. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.

Other Meds:

Current Illness:

ID: 0923288
Sex: F
Age: 42
State: CA

Vax Date: 12/23/2020
Onset Date: 12/31/2020
Rec V Date: 01/06/2021
Hospital:

Lab Data:

Allergies: none

Symptoms: 8 days after vaccine given (1st dose), urticaria around site of injection which resolved within 24 hours with 180mg fexofenadine.

Other Meds: none

Current Illness: none

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm