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: 0920097
Sex: F
Age:
State: AL

Vax Date: 12/18/2020
Onset Date: 12/18/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Date: 20201223; Test Name: FLU testing; Test Result: Negative ; Test Date: 20201223; Test Name: Nasal Swab, PCR; Test Result: Negative

Allergies:

Symptoms: Asthma exacerbation; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Lot number: ek5730), via an unspecified route of administration at the left arm on 18Dec2020 13:00 at a single dose for COVID-19 immunization. Medical history includes adult onset asthma, seasonal allergies, anxiety and depression. The patient was not pregnant at the time of vaccination. Concomitant medication included atomoxetine hydrochloride (STRATTERA), vortioxetine hydrobromide (TRINTELLIX), ethinylestradiol and levonorgestrel (SEASONIQUE). The patient experienced asthma exacerbation following vaccination that started 2 hours after (18Dec2020, 3PM) and worsened 1 day later. The pulmonologist advised to nebulize the patient with albuterol due to shortness of breath tightness and clear secretions despite MDI. The patient had to restart controller Symbicort (still with 3x day albuterol on 23Dec2020) and seen at an urgent care. Oral steroids were prescribed (Medrol dose pack). The patient was not hospitalized for the event but the resulted in Emergency room/department or urgent care visit. The event was reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has been tested for Flu and COVID (Nasal Swab, PCR) Testing on 23Dec2020 and results were negative. The outcome of the event was recovering.

Other Meds: STRATTERA; TRINTELLIX; SEASONIQUE

Current Illness:

ID: 0920098
Sex: F
Age:
State:

Vax Date: 12/22/2020
Onset Date: 12/01/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: burning itching and having welts over her body; burning itching and having welts over her body; This is a spontaneous report from a non-contactable other healthcare professional (technologist, patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in Dec2020, the patient experienced burning itching and having welts over her body. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0920099
Sex: F
Age:
State: TX

Vax Date: 12/21/2020
Onset Date: 12/23/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Date: 202012; Test Name: heartbeat; Result Unstructured Data: Test Result:subsided; Comments: after 36-48 hours; Test Date: 20201223; Test Name: heartbeat; Result Unstructured Data: Test Result:skipping a beat almost every 3-5 minutes; Comments: 11:00 pm

Allergies:

Symptoms: heart palpitations; felt like heart was skipping a beat almost every 3-5 minutes; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration at the right arm on 21Dec2020 08:00 at a single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination and had no known allergy. The patient had no concomitant medications. On 23Dec2020 at 11 pm, approximately 36 hours after getting vaccine, the patient had 36+ hours of heart palpitations, felt like heart was skipping a beat almost every 3-5 minutes. Events subsided after 36-48 hours. The patient was not hospitalized for the events. There was no treatment given for the events. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 0920100
Sex: F
Age:
State: IN

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache; nausea; arm pain at the injection site; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ek5730), intramuscular at the left arm on 23Dec2020 14:30 at a single dose for COVID-19 immunization. Medical history included anxiety. The patient was not pregnant at the time of vaccination and had no known allergy. Concomitant medication included trazodone and fluoxetine hydrochloride (PROZAC). On 24Dec2020 6 am, the patient experienced headache and moderate nausea for about 48-32 hours with significant arm pain at the injection site. The patient was not hospitalized for the events and did not receive any treatment. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020.

Other Meds: ; PROZAC

Current Illness:

ID: 0920101
Sex: F
Age:
State:

Vax Date: 12/24/2020
Onset Date: 12/24/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Date: 20201225; Test Name: fever; Result Unstructured Data: Test Result:fever

Allergies:

Symptoms: Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a non-contactable other-HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231) (Brand= Pfizer), via an unspecified route of administration on 24Dec2020 07:15AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was workplace clinic. None medical history. The patient's concomitant medications was not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies included Ibuprofen based pain medicine. On 24Dec2020, patient experienced injection site pain; chills; facial flushing. 25Dec2020 fever. 26Dec2020 rhinorrhea. 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. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 0920102
Sex: F
Age:
State: TX

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fine raised red rash over her body; throat swelling; diarrhea; high pitched cough productive with clear thin secretions; This is a spontaneous report from a contactable nurse (patient herself). A 59-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on left arm from at 12:30 PM on 23Dec2020 at single dose for COVID-19 immunization. Medical history included depression. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), triazolam (HALCION), fluoxetine hydrochloride (PROZAC), paracetamol (TYLENOL). The patient previously took Lamictal and experienced rash, codeine and experienced hallucination, lamictal for drug allergy, codeine and experienced drug allergy. On 24Dec2020 mid-day (11:00 AM), the patient developed the following S/S (signs and symptoms, which were similar to a Lamictal rash): Fine raised red rash over her body, but significantly heavier to face, neck and lower legs; throat swelling with a high pitched cough (with no difficulty breathing) productive with clear thin secretions; diarrhea. The patient took 6 Benadryl every 4-6 hours, Pepcid twice daily, and had an epi pen available (but did not need it). The cough and rash resolved by late Sunday evening (27Dec2020). The patient did not report to ED because she felt the symptoms were manageable at home. All events reported as non-serious. The outcome of events red rash and cough were recovered on 27Dec2020, the outcome of rest events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19.

Other Meds: WELLBUTRIN; HALCION; PROZAC; TYLENOL

Current Illness:

ID: 0920103
Sex: F
Age:
State: CT

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

Lab Data:

Allergies:

Symptoms: numbness and itching in the roof of mouth; numbness and itching in the roof of mouth; This is a spontaneous report from a contactable healthcare professional. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ 1685), intramuscular on the left arm on Dec2020 at single dose for COVID-19 immunisation. Medical history included hypertension and GERD. Concomitant medication included metoprolol, dexlansoprazole, ondansetron and propranolol. The patient previously took gadolinium and midazolam and experienced known allergies: gadolinium and midazolam. The patient experienced numbness and itching in the roof of mouth on Dec2020. Patient received BENADRYL as treatment. The outcome of the events was recovering.

Other Meds: ; ; ;

Current Illness:

ID: 0920104
Sex: F
Age:
State: TX

Vax Date: 12/19/2020
Onset Date: 12/19/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Intermittent dizziness and it doesn't last very long usually its usually couple of times a day; This is a spontaneous report from a contactable nurse, the patient. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot "EJ then it's either I or 1, I don't know then 685", Expiry Date: 31Mar2021) solution for injection intramuscular on 19Dec2020 (at the age of 31-years-old) as a single dose for COVID-19 vaccination. Pregnancy status was not reported. Medical history was unknown. Concomitant medication included multivitamins. The patient stated, "I just wanted to know if it's normal or not, I got this first half of the Covid Vaccine on the 19Dec2020 and ever since I have been having like intermittent dizziness (19Dec2020) and it doesn't last very long usually its usually couple of times a day but I just wanted to know if that's normal and if it is how long before it stops?" No treatment was provided for the event intermittent dizziness. The outcome of the event intermittent dizziness was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 0920105
Sex: M
Age:
State:

Vax Date: 12/26/2020
Onset Date: 12/28/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patient had COVID two days after vaccination; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) via an unspecified route of administration on 26Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had COVID two days after vaccination (28Dec2020). 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: 0920106
Sex: F
Age:
State: FL

Vax Date: 12/18/2020
Onset Date: 12/18/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Date: 20201218; Test Name: Fever; Result Unstructured Data: Test Result:101; Comments: Fever of 101 Chills; Test Name: CT of head; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptoms: Fever of 101 Chills; body aches; ocular migraine; abdominal cramping and pain; This is a spontaneous report received from a contactable Pharmacist. A female patient of unspecified age (reported as "44 without unit") received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ett9899) via Intramuscular on 18Dec2020 13: 00 at single dose in the arm left for COVID-19 immunisation. Medical history was none. Concomitant medications included claritin, OCP. The patient previously took cephalosporin and experienced allergy. The patient experienced Fever of 101 Chills, body aches, ocular migraine, then developed abdominal cramping and pain at 18Dec2020 19:00. Symptoms lasted 3 days and then completely resolved. Adverse events result in emergency room/department or urgent care. The patient received treatment for events and underwent lab tests, which included CT of Head. Outcome of events was recovered on 22Dec2020.

Other Meds: CLARITIN [CLARITHROMYCIN]

Current Illness:

ID: 0920107
Sex: U
Age:
State: TX

Vax Date: 12/15/2020
Onset Date: 12/27/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: dizzy; weak; S/He had started feeling really bad; s/he didn't feel well; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) via an unspecified route of administration on 15Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 27Dec2020, the patient started feeling dizzy and weak. S/He had started feeling really bad; s/he didn't feel well. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0920108
Sex: F
Age:
State: AZ

Vax Date: 12/23/2020
Onset Date: 12/27/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Date: 20201227; Test Name: COVID test result (antigen rapid response test); Test Result: Positive

Allergies:

Symptoms: four days after getting her first COVID vaccine injection, she had a COVID positive test result (antigen rapid response test); four days after getting her first COVID vaccine injection, she had a COVID positive test result (antigen rapid response test); This is a spontaneous report from a contactable consumer. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730/expiration date unknown), dose number 1 via an unspecified route of administration on 23Dec2020 09:00 at a single dose on the left arm for COVID-19 immunization. Medical history included vaccination of unspecified flu vaccine in Oct2020. No vaccines or new medications were received on the day of the vaccination. The patient stated that on 27Dec2020, four days after getting her first COVID vaccine injection, she had a COVID positive test result (antigen rapid response test). The patient stated that she had been mostly asymptomatic for COVID. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 0920109
Sex: F
Age:
State: PA

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Date: 20201223; Test Name: temperature; Result Unstructured Data: Test Result:99.0 Fahrenheit; Comments: At approximately 16:00; Test Date: 20201223; Test Name: temperature; Result Unstructured Data: Test Result:99.1 Fahrenheit; Comments: at approximately 22:00

Allergies:

Symptoms: My eyes were glassy; Lightheadedness and dizziness; Fatigue; Low-grade temperature of 99.0 F with chills; Low-grade temperature of 99.0 F with chills; This is a spontaneous report from a contactable nurse (patient herself). This 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140), via intramuscular, on 23Dec2020 at 13:45 at single dose for COVID-19 immunisation Vaccine location was left arm. The patient was not pregnant. The patient was vaccinated at hospital, age at vaccination was 25-year-old. Relevant medical history included ongoing irritable bowel syndrome, ongoing allergies tree nuts and peanuts. Past drug history included allergy to penicillin. Relevant concomitant medications included famotidine, sertraline, and ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) for birth control. No other vaccine was received in four weeks At approximately 16:00 on 23Dec2020, she had sudden onset of fatigue, a low-grade temperature of 99.0 F with chills. By 17:30, she was also bringing to experience lightheadedness and dizziness. That night at approximately 22:00, she had temperature of 99.1. On 24Dec2020, she experienced lightheadedness and dizziness the entire day, from waking up to going to bed later that night. Her eyes were glassy and she would feel an impulse of dizziness go distinctly from the right side of her head to the left, and then felt more dizzy after that. It was constant throughout the entire day and would occur while she was sitting, standing, or moving around. On 25Dec2020, she was tired but the dizziness had gone away. Pre-vaccination and post-vaccination COVID tests were not performed. No therapeutic measures were taken as result of the events. The patient had recovered from the events in Dec2020.

Other Meds: ; SERTRALINE HCL; JUNEL FE

Current Illness: Allergy to nuts; Irritable bowel syndrome; Peanut allergy

ID: 0920110
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Fever; headache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced fever and headache for almost 10 days in Dec2020. The outcome of the events was not recovered. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0920111
Sex: F
Age:
State: CA

Vax Date: 12/26/2020
Onset Date: 12/26/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: intermittent Heart palpitations that began at 0800; Severe fatigue that began 4 hours post injection and lasted approx 48 hrs; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received their first dose of BNT162B2 (lot number: Ek 5730; expiry date not reported), intramuscularly on the right arm on 26Dec2020 at 08:30 at single dose for COVID-19 immunization. Medical history included known allergies to milk and eggs. Concomitant medication included lisinopril. The patient experienced severe fatigue that began 4 hours post injection and lasted approx. 48 hrs on 26Dec2020 and intermittent heart palpitations that began at 08:00 on 28Dec2020. The patient recovered from severe fatigue on an unspecified date in Dec2020 (reported as approx. 48hrs) while the outcome of intermittent heart palpitations was unknown.

Other Meds:

Current Illness:

ID: 0920112
Sex: F
Age:
State: IA

Vax Date: 12/22/2020
Onset Date: 12/26/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: developed shingles outbreak 4 days later; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on 22Dec2020 at single dose in the upper arm via unspecified route of administration. The patient had not medical history. Concomitant medications were not reported. On 26Dec2020 the patient developed shingles outbreak. The outcome of the event was not recovered. Information on the lot/batch number has been requested

Other Meds:

Current Illness:

ID: 0920113
Sex: M
Age:
State: CA

Vax Date: 12/20/2020
Onset Date: 12/21/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Date: 20201221; Test Name: Fever; Result Unstructured Data: Test Result:101.0 Fahrenheit; Test Date: 20201223; Test Name: Covid tested via Nasal Swab; Test Result: Negative ; Comments: PCR result negative

Allergies:

Symptoms: Fever of 101.0 F; chills with fever; fatigue; night sweats; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 20Dec2020 15:00 at single dose for COVID-19 immunization. Vaccine location provided as Left arm. Medical history included Scleroderma, interstitial lung disease. There were no Known allergies to medications, food, or other products. Concomitant medication (reported as other medications the patient received within 2 weeks of vaccination) included ibuprofen, ergocalciferol (VITAMIN D), cetirizine hydrochloride (CITIRIZINE), famotidine. There were no other vaccines received within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior vaccination. The patient experienced Fever of 101.0 F, chills with fever, fatigue, night sweats on 21Dec2020 20:00. No treatment received for all reported events. The patient had Covid tested via Nasal Swab post vaccination with PCR result negative on 23Dec2020. The outcome of the events was recovered in Dec2020. This case was assessed as non-serious.

Other Meds: ; Vitamin D; CITIRIZINE [CETIRIZINE HYDROCHLORIDE];

Current Illness:

ID: 0920114
Sex: U
Age:
State:

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

Lab Data: Test Name: Covid-19; Test Result: Positive ; Comments: tested positive after receiving the first dose

Allergies:

Symptoms: tested positive after receiving the first dose; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events in two patients. This is the first of two reports. A patient of unspecified age and gender received their first dose of BNT162B2 (lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter queried on after low long will the antibodies be present after receiving first dose and would it show up in antibody testing. Further reported they have 1-2 patients who tested positive after receiving the first dose. The reporter also queried any recommendations on vaccinating them for the 2nd dose if they test positive in between the two doses and that they have one vial left over from last week, today at noon the 5days will expire. If they dilute it now at 10am do they have to use it by noon or add 6hours from the time of dilution. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on an unspecified date. The outcome of the event was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020516039 same drug and event in a different patient

Other Meds:

Current Illness:

ID: 0920115
Sex: U
Age:
State:

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

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

Allergies:

Symptoms: tested positive after receiving the first dose; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events in two patients. This is the second of two reports. A patient of unspecified age and gender received their first dose of BNT162B2 (lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter queried on after low long will the antibodies be present after receiving first dose and would it show up in antibody testing. Further reported they have 1-2 patients who tested positive after receiving the first dose. The reporter also queried any recommendations on vaccinating them for the 2nd dose if they test positive in between the two doses and that they have one vial left over from last week, today at noon the 5days will expire. If they dilute it now at 10am do they have to use it by noon or add 6hours from the time of dilution. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on an unspecified date. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020516038 same drug and event in a different patient

Other Meds:

Current Illness:

ID: 0920116
Sex: F
Age:
State: TN

Vax Date: 12/26/2020
Onset Date: 12/27/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache; soreness at injection site; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown since misplaced/discarded) via intramuscular on 26Dec2020 17:30 on left arm at a single dose for COVID-19 immunization. The patient medical history included anxiety and attention deficit hyperactivity disorder (ADHD). The patient allergy for reglan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included atomoxetine hydrochloride (STRATTERA) and sertraline hydrochloride (ZOLOFT). The patient experienced Headache, soreness at injection site, nausea, fatigue on 27Dec2020 08:00 AM. The patient received Excedrin as treatment for the events. The outcome of the events was recovering. Information on the Lot/Batch number has been requested.

Other Meds: STRATTERA; ZOLOFT

Current Illness:

ID: 0920117
Sex: F
Age:
State: CA

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Date: 20201221; Test Name: body temperature; Result Unstructured Data: Test Result:low grade fever 100.3; Test Date: 202012; Test Name: COVID-19; Result Unstructured Data: Test Result:negative

Allergies:

Symptoms: body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to explain it very well; change of sense of taste; loss of taste; body rash on upper torso only described as "not bad" and "not itchy" or bothersome; low grade fever 100.3; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration in left upper arm, on 21Dec2020 06:30 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital.The patient's weight was 67.13 kg and height was 173 cm. The patient's medical history included nausea and flu like symptoms. Concomitant medications included omeprazole(PROTONIX) from Dec2020 at 40mg once a day for nausea. The patient stated that a week before she received the vaccine she had flu like symptoms and she was tested for COVID-19 and the test result was negative in Dec2020. The patient experienced low grade fever 100.3 which started in the evening of the vaccine(21Dec2020) and she took Tylenol and went to sleep and the next day felt better, which resolved by the next day(22Dec2020). The patient experienced body aches on an unknown date, body rash on upper torso only described as "not bad" and "not itchy" or bothersome which started on 21Dec2020(a few hours after receiving vaccine) and resolved on 23Dec2020. The patient experienced change of sense of taste, "everything tastes metallic and it's kind of hard to explain it very well" on 24Dec2020. The patient experienced loss of tastewhich started on either 23Dec2020 or 24Dec2020. She was starting to be able to taste. She has anything it is bland. She can taste some saltiness. That started coming back on approximately Saturday, 26Dec2020. The patient experienced decreased appetite, "cotton mouth" on an unknown date. The outcome of the events "low grade fever 100.3", "body rash on upper torso only described as "not bad" and "not itchy" or bothersome", "loss of taste" was recovered and of other events was unknown.

Other Meds: PROTONIX [OMEPRAZOLE]

Current Illness:

ID: 0920118
Sex: F
Age:
State: NC

Vax Date: 12/20/2020
Onset Date: 12/27/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: raised bumps/hives all over body; Generalized Rash that is itchy; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received their first dose of BNT162B2 (lot number: ER5730; expiration date unknown), via an unspecified route of administration on the right arm on 20Dec2020 at 11:30 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included amoxicillin. The patient experienced Generalized Rash that is itchy, raised bumps/hives all over body on 27Dec2020. Therapeutic measures were taken as a result of the events which included treatment with hydroxyzine. The patient did not recover from the events.

Other Meds:

Current Illness:

ID: 0920119
Sex: F
Age:
State: PA

Vax Date: 12/24/2020
Onset Date: 12/26/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Wheezing; Cough; Profound sleepiness; This is a spontaneous report from a contactable other healthcare professional (HCP). A 52-year-old female patient received the first dose of bnt162b2 (lot number: EK9231), intramuscular on the left arm on 24Dec2020 at 11:30 at a single dose for immunization. Medical history included HBP, asthma, radicular pain and migraines. The patient's concomitant medications were not reported. The patient previously took tetracycline and experienced drug allergy. The facility where the most recent COVID-19 vaccine was administered was at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 and has not been tested for COVID-19. On 26Dec2020 at 05:00, the patient experienced wheezing, cough and profound sleepiness, and was prescribed Proair Inhaler as treatment for the events. The outcome of the events was not resolved.

Other Meds:

Current Illness:

ID: 0920120
Sex: F
Age:
State: OK

Vax Date: 12/16/2020
Onset Date: 12/16/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: ringing in the ears; slight headache; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the first dose of bnt162b2 (Batch/lot number: EH9899), via an unspecified route of administration (reported as one injection to left arm) on 16Dec2020 at a single dose for COVID-19 vaccination. Medical history included allergy. Concomitant medication included prednisolone acetate (PREDNISOLONE ACETATE, Manufacturer: Pacific Pharma. NDC: 60758119-05, Lot: E88990, Exp. date: Feb2023) 1%, four eyedrops a day until she is out, 7 days at most or a week for allergy. The nurse called as a patient about the Pfizer COVID-19 vaccine, which she received on 16Dec and had a headache - only a slight headache, the day after and ringing in her ears that has not gone away. She says it was her first injection of the vaccine. The patient says she was given the vaccine through her work, and says she had a headache that evening and then a slight headache the next day. She says that the ringing in the ear, she noticed the next day in the morning. She says it is hard to tell if the ringing is just one ear or not, the ringing is staying about the same, and is more in her right ear. She says she has not had treatment for either the headache or the ringing in her ears, and the headache improved on its own. She had no new medications and didn't receive any other vaccines when she got this one. She says that she went to the eye doctor in the past week and he started her on eye drops, she has never been on prednisone for allergies, and for her eyes he gave her prednisone drops and allergy drops. She says she started that medication on the evening she got it, Monday 21Dec. She would like to know if there could be some type of allergy, she doesn't know if she should take the second dose of the vaccine. She says she doesn't know if there is something she should do for the ringing in her ears, like a common treatment or anything, or if others have been reporting this. She says she saw on the website that one side effect said ringing in ears, but she isn't sure if the website was either of those provided by call handler for further information. The outcome of the events slight headache was resolving while ringing in the ears had not resolved.

Other Meds:

Current Illness:

ID: 0920121
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: angioedema; swelling of the lips; This is a spontaneous report from a non-contactable nurse (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as COVID-19 vaccine. Medical history included angioedema 23 years ago. Concomitant medications were not reported. The caller wanted to report AE for the COVID-19 vaccine. AE reported that she took the COVID-19 vaccine and after 23 hours, she developed angioedemia on unspecified date. Additionally, she said that she woke up with swelling of the lips on an unspecified date. Given the AE from the first request, it was inquired if it was recommended to get a second dose. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of angioedemia with lip swelling cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. 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: 0920122
Sex: F
Age:
State:

Vax Date: 12/18/2020
Onset Date: 12/01/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Date: 202012; Test Name: SARS-CoV-2 rapid test; Test Result: Positive

Allergies:

Symptoms: she had a rapid test performed which indicated a positive test result; she had a rapid test performed which indicated a positive test result; This is a spontaneous report from a contactable nurse (patient). A female patient of unspecified age received the first dose of BNT162B2, via an unspecified route of administration on 18Dec2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient indicated she received the first dose of the vaccine on the 18th and due to a family member testing positive, she had a SARS-CoV-2 rapid test performed in Dec2020 which indicated a positive test result. Her employment was questioning as to whether this is due to her receipt of vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported information is limited. 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: 0920123
Sex: F
Age:
State:

Vax Date: 12/17/2020
Onset Date: 12/27/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Date: 20201227; Test Name: covid; Result Unstructured Data: Test Result:Positive

Allergies:

Symptoms: resident (patient) tested positive for COVID, 10 days after the first dose of COVID vaccine; resident (patient) tested positive for COVID, 10 days after the first dose of COVID vaccine; This is a spontaneous report from a contactable physician via a Pfizer sponsored program Pfizer First Connect. A 29-year-old female patient received their first dose of BNT162B2 (lot number and expiry date not reported), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter wanted to know how long they have to wait for the second dose of the COVID vaccine as her resident (patient) tested positive for COVID on 27Dec2020, 10 days after the first dose of COVID vaccine given to her on the 17Dec2020. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 27Dec2020. 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 of subject vaccine cannot be excluded for the reported events of LOE and SARS-CoV-2 test positive, based on temporal relationship. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information.

Other Meds:

Current Illness:

ID: 0920124
Sex: M
Age:
State: AZ

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Name: Antibody test; Result Unstructured Data: Test Result:Negative; Test Name: Covid Test; Result Unstructured Data: Test Result:No positive results; Comments: He has had No positive results for the Covid Test prior to the vaccine.

Allergies:

Symptoms: he couldn't take a deep breathe; smothering feeling; felt an out of body; light headedness; This is a spontaneous report from two contactable physician received via Medical Information Team. A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right shoulder on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that: "on 23Dec2020, a minute after vaccination he felt as if he couldn't take a deep breathe, it was like a smothering feeling, then he felt an out of body and light headedness, this only lasted for 3 minutes". The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test which resulted negative and SARS-CoV-2 test: no positive results for the COVID Test prior to the vaccine. The patient outcome of the events was recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0920125
Sex: F
Age:
State: AZ

Vax Date: 12/26/2020
Onset Date: 12/26/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:high; Test Name: Blood pressure; Result Unstructured Data: Test Result:160/100; Test Name: Temperature; Result Unstructured Data: Test Result:99.4 Fahrenheit; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown results; Test Name: Heart rate; Result Unstructured Data: Test Result:high; Test Name: Heart rate; Result Unstructured Data: Test Result:120; Test Name: Heart rate; Result Unstructured Data: Test Result:150

Allergies:

Symptoms: fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was something hot going through my body; She said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot.; It made it hard to breathe; felt like a rush of hot and felt horrible; My heart rate and BP was high; My heart rate and BP was high; she looked pale, and did not have rashes; This is a spontaneous report from a contactable Other HCP reporting for herself A 43-years-old female patient received bnt162b2 (BNT162B2; Lot # EH9899) vaccine , via an unspecified route of administration on 26Dec2020 10:15 at single dose for Covid-19 immunisation . Medical history included thyroid cancer from 2009 , blood calcium decreased from an unknown date , depression from an unknown date , anxiety from an unknown date. Concomitant medication included cetirizine hydrochloride (ZYRTEC) [fluoxetine (FLUOXETINE), calcium carbonate, colecalciferol, menaquinone (VITAMIN K2 + VITAMIN D3 + CALCIUM), calcium carbonate (TUMS) vitamin C (VITAMIN C) , vitamin D2 (VITAMIN D2), levothyroxine sodium (SYNTHROID). On 26Dec2020, about thirty minutes after receiving the vaccine the patient suddenly felt there was something hot going through her body it made it hard to breathe , felt like a rush of hot and felt horrible , her heart rate and BP were high, she said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot. , she looked pale, and did not have rashes. The patient believed she was having an allergic reaction and gave a shot of epinephrine before going to ER. The doctors told her that her oxygen was fine (SatO2: 98%) and therefore she was not having an allergic reaction. She felt like she had trouble breathing. Her heart rate would go up to 120 to 150. Her blood pressure was high. She also received a shot of lorazepam (ATIVAN) at about 15:30 on 26Dec2020. She went bed and woke up on 27Dec2020, she had fever at 99.4?F and had nausea. The outcome of the reported events was unknown. The patient stated this was a terrible experience and she felt like she was going to die. Also she is not going to receive the second shot of the vaccine.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ; VITAMIN K2 + VITAMIN D3 + CALCIUM; TUMS [CALCIUM CARBONATE]; VITAMIN C [ASCORBIC ACID]; VITAMIN D2; SYNTHROID

Current Illness:

ID: 0920126
Sex: U
Age:
State:

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

Lab Data: Test Name: COVID-19 test; Test Result: Positive ; Comments: tested positive for COVID-19

Allergies:

Symptoms: tested positive for COVID-19; was given the first COVID-19 dose. After some time, the employee got symptomatic and was tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of bnt162b2, via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient who is employed in a hospital tested negative for COVID-19 then was given the first COVID-19 dose. After some time, the patient got symptomatic and was tested positive for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported information is limited. The case will be reassessed upon receipt of follow up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0920127
Sex: F
Age:
State: PA

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Angioedema of lips, throat, eyes, hands. Flushing of hands; Angioedema of lips, throat, eyes, hands. Flushing of hands; Dizziness; Fatigue; Legs became heavy; Joint stiffness of hands; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJ 1685), intramuscular on the left arm on 23Dec2020 at 06:30 AM in a hospital at a single dose for COVID-19 immunization. Medical history included known allergies of seasonal allergies, cats, and metals; migraines, chronic idiopathic urticaria, and angioedema. The patient was not pregnant and did not have any other vaccine in four weeks. The patient did not have COVID prior to the vaccination and did not test positive to COVID post vaccination (also reported as not been tested for COVID-19 after the vaccination). Concomitant medication included propranolol, cetirizine hydrochloride (ZYRTEC), and sertraline (reported as other medications in two weeks). On 23Dec2020 at 06:45 AM, the patient experienced immediate symptoms of angioedema of lips, throat, eyes, hands; flushing of hands, dizziness, fatigue, legs became heavy, and joint stiffness of hands. She was monitored by colleagues for an hour, prescription for Epi pen refilled, and available angioedema and fatigue persisted for three days. It was reported that the patient was not treated for the adverse events but it was also reported that the AE treatment also included X-ray and antibiotic. Outcome of the events was recovered in Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of immediate symptoms of angioedema of lips, throat, eyes, hands, flushing of hands, dizziness, fatigue, legs became heavy, and joint stiffness of hands cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. 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: ; ZYRTEC [CETIRIZINE HYDROCHLORIDE];

Current Illness:

ID: 0920128
Sex: F
Age:
State: MD

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Date: 20201228; Test Name: HR; Result Unstructured Data: Test Result:130; Comments: 130s; Test Date: 202012; Test Name: Covid test; Test Result: Negative

Allergies:

Symptoms: tachycardia; dizziness; throat swelling; blotches on chest; palpitations; chest tightness/had residual mild chest discomfort and noticed 2 blotches on chest in car; metallic taste in mouth; This is a spontaneous report from a contactable physician (patient). A 33-year-old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) via Intramuscular on 28Dec2020 12:30 PM at single dose in the arm left for COVID-19 immunisation. Medical history included Bee venom (anaphylaxis), hereditary fructose intolerance (HFI, HFI as above but no previous issues with sucrose containing vaccines) and Known allergies: Bee venom (anaphylaxis). Concomitant medications included Linaclotide, Adderall, polyethylene glycol 3350. Roughly 5-7 minutes after injection, the patient experienced palpitations, chest tightness, and metallic taste in mouth - sensations mostly subsided after another 5 minutes so did not report. Left center after 30 mins, the patient had residual mild chest discomfort and noticed 2 blotches on chest in car. Drove home - on the way at 13: 15 (45 mins post vaccine), developed throat swelling, severe chest tightness, tachycardia (HR 130s), and dizziness. Severe symptoms (throat swelling particularly) subsided after 5 minutes but other symptoms persisted for another hour. Used albuterol, had epi pen ready but didn't use. Now 3 hours out, feeling close to baseline. The patient underwent lab tests, which included Covid test post vaccination with Negative result in Dec2020. The patient received treatment for events, which included Albuterol. Outcome of events was recovering.

Other Meds: ; ADDERALL; POLYETHYLENE GLYCOL 3350

Current Illness:

ID: 0920129
Sex: F
Age:
State: IL

Vax Date: 12/24/2020
Onset Date: 12/25/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Painful, swollen lymph nodes in L chest; Painful, swollen lymph nodes in L chest; arm pit, muscle aches; arm pit, muscle aches; This is a spontaneous report from a contactable nurse (patient) reporting for herself. A 37-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0140), via an unspecified route of administration at left arm on 24Dec2020 09:30 at single dose for COVID-19 immunization at a hospital. The patient's medical history included hypertension, depression and anxiety. No known allergies to medications, food, or other products. Concomitant medication included alprazolam (XANAX), diclofenac (VOLTAREN), bupropion hydrochloride (WELLBUTRIN XL), amlodipine besilate (NORVASC), and diphenhydramine hydrochloride (BENADRYL). No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 post the vaccination. On 25Dec2020 05:00, the patient experienced painful, swollen lymph nodes in left (L) chest, and arm pit, muscle aches. No treatment was taken for the above events. The outcome of the events was recovering.

Other Meds: XANAX; VOLTAREN [DICLOFENAC]; WELLBUTRIN XL; NORVASC; BENADRYL

Current Illness:

ID: 0920130
Sex: F
Age:
State: CA

Vax Date: 12/22/2020
Onset Date: 12/24/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Angioedema; This is a spontaneous report from a contactable Other Health Professional (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL1284, intramuscular in the right arm (also reported as right shoulder), first dose on 22Dec2020 00:30 at a single dose for Covid-19 immunization. The patient's relevant medical history included severe reaction to some animal dander and pollen, severe reactions to poison oak, possible drug induced reactions (unspecified) post C-section, mild rash with influenza vaccine this year (2020) (with no other hx of adverse reaction to a vaccine); had allergies to pollen, mold, some animals. The patient previously took influenza vaccine (split virion, inactivated) and experienced rash. The patient had no covid prior vaccination nor was she tested post vaccination. Adverse event reported was angioedema on 24Dec2020 with outcome of recovering. Systems started appearing on 23Dec2020 evening with slight rash and fluid collection under right eye. Developed more rash on 24Dec2020. In the evening to early morning of 25Dec2020, symptoms worsened significantly. Rapid swelling to face occurred. Swelling was concentrated around eyes and cheeks the most. Both right and left side of the face and neck were affected. However, the right side face had a more pronounced reaction. MD ordered oral prednisone and Benadryl as treatment plan. Also, ordered episode-pen for a worst case scenario. Symptoms have been improving under treatment but still persist some. The events were reported as non-serious. The adverse event start date was 24Dec2020 (as reported). The event resulted in doctor or other healthcare professional office/clinic visit.; Sender's Comments: There is a reasonable possibility that the event angioedema was related to BNT162b2 based on known drug safety profile and 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: 0920131
Sex: F
Age:
State: NY

Vax Date: 12/17/2020
Onset Date: 12/18/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: got a mild generalized headache; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received bnt162b2 (lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration on the right deltoid on 17Dec2020 at 11:00 at a single dose for COVID-19 immunization. Medical history included ongoing migraine headache - stated she was diagnosed with migraines at 12 or 13 years old. There were no concomitant medications. The patient previously received influenza vaccine in Sep2020 for immunization. The patient got a mild generalized headache on 18Dec2020 and still has a headache after all these days. The patient received the COVID-19 Vaccine at the hospital where she works on 17Dec2020 at 11:00AM. She said she went to Pfizer's website for the COVID-19 Vaccine, and the Pfizer website said a headache that develops after receiving the COVID-19 vaccine lasts a few days. She said no matter what medication she is using for her headache, the medication is not working, and she still has the headache. She stated she went to her employer's employee health department, and the employee health department had no information to give her about the COVID-19 Vaccine side effects and what to do about the side effects. Reported the COVID-19 Vaccine was offered as an elective vaccine at the hospital where she works, saying the hospital offered the COVID-19 Vaccine to all its employees. As for treatment, she has taken only over-the counter products to treat her headache. She said she has been taking Tylenol 500 mg caplets, UPC Number: Unknown, Lot Number: PFA044, and Expiration Date: Mar2023. She said she has been taking 2 caplets of Tylenol 500 mg almost daily to see if she can get the edge off of her headache. She said she keeps trying the Tylenol hoping the Tylenol will one day help her headache. She clarified that on most days she is taking 2 Tylenol 500mg caplets once a day, but there have been a couple days where she took 2 Tylenol 500mg caplets twice during the day. Reported she also tried (pharmacy name) brand Migraine Relief Caplets. Reported the headaches she is experiencing now are not like the headaches she has had prior to getting the COVID-19 Vaccine. She said she goes to a neurologist for her migraine headaches, clarifying the headaches she is having now are just a generalized, dull headache. She said she can function at work with the headaches she is having now. She said the headaches are just annoying and headaches don't go away. She said the headaches are not debilitating like her migraine headaches. She said with a migraine headache, she would have to call out at work, but with the headaches she is having now, she can still function. She said the headaches she is experiencing now are not like the migraine headaches she has had prior to getting the COVID-19 Vaccine. She said she goes to a neurologist for her migraine headaches. She said the headaches she is having now are just a generalized, dull headache, and she can function at work. She said the headaches are just annoying, and don't go away. She said the headaches are not debilitating like her migraine headaches. She said with a migraine headache, she would have to call out at work, but with the headaches she is having now, she can still function. The event had not resolved.

Other Meds:

Current Illness: Migraine headache

ID: 0920132
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Throat swelling; Dizziness; This is a spontaneous report from a non-contactable other healthcare professional (HCP). A male patient of unspecified age received the first dose of bnt162b2 (lot number: EL1284), intramuscularly on the left arm on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced throat swelling and dizziness on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 0920133
Sex: F
Age:
State: AZ

Vax Date: 12/24/2020
Onset Date: 12/24/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Date: 20201224; Test Name: heart rate; Result Unstructured Data: Test Result:Racing

Allergies:

Symptoms: chest flushing; Racing heart rate; This is a spontaneous report from a contactable nurse (patient). A 51-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in the left arm on 24Dec2020 11:30 at a single dose for COVID-19 immunization. The patient has no medical history. Concomitant medication included ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, lysine hydrochloride, magnesium oxide heavy, manganese sulfate monohydrate, nicotinamide, potassium iodide, potassium sulfate, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acid succinate, zinc oxide (ONE A DAY MULTI VITAMIN & MINERALS). The patient did not receive other vaccine in four weeks. The patient previously took ephedrine and experienced allergies. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. The patient experienced chest flushing and racing heart rate on 24Dec2020 11:45. Outcome of the events was recovered in Dec2020; no treatment was needed for the events. The events was assessed as non-serious.

Other Meds: ONE A DAY MULTI VITAMIN & MINERALS [ASCORBIC ACID;BETACAROTENE;CALCIUM CARBONATE;CALCIUM PANTOTHENAT

Current Illness:

ID: 0920134
Sex: M
Age:
State:

Vax Date: 12/19/2020
Onset Date: 12/26/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: muscle aches; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced muscle aches on 26Dec2020. Outcome of the event was unknown. No follow-up attempts are possible. Information about Lot/Batch number could not be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 0920135
Sex: F
Age:
State:

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: after receiving the vaccine, she started bleeding heavily and is still currently bleeding; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) with unknown lot number and expiration date, 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, a dispatch operator for a hospital, reported that she received the COVID vaccine a week ago on 22Dec2020. She stated that her period stopped two days prior to receiving the COVID vaccine. On 22Dec2020, after receiving the vaccine, she started bleeding heavily and is still currently bleeding. The patient wanted to know what she should do to stop the bleeding. The clinical outcome of the event was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0920136
Sex: M
Age:
State: IL

Vax Date: 12/20/2020
Onset Date: 12/01/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Date: 202012; Test Name: temperature; Result Unstructured Data: Test Result:100.3 Fahrenheit; Test Date: 20201224; Test Name: COVID-19 nasal swab test; Test Result: Negative

Allergies:

Symptoms: feeling rundown; feeling sick; headache; Flu like symptoms; Chills; intermittent fever/ low grade fever; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received first dose of BNT162B2 (lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration, in left arm on 20Dec2020 at single dose for COVID-19 immunization. His work was offering the vaccine to them, and he was a first responder, so he went to the hospital where they were administering it. Medical history was none. There were no concomitant medications. The patient received no other vaccines or new medications with the COVID-19 vaccine. The patient experienced headache, flu like symptoms and chills on 20Dec2020 and intermittent fever in Dec2020. The patient was a first responder who received the COVID-19 vaccine on 20Dec2020. He experienced headache, flu like symptoms and intermittent fever. The patient stated that he started feeling "a little bit better" for a couple of days but now he has a fever again. His work had him take a COVID-19 test on 24Dec2020 due to his symptoms and he was negative. He was asking what he should do since he is experiencing continued symptoms. The patient said he has some questions about the COVID vaccine, since he received the first dose on 20Dec2020. He said that the day he had it he had a bad headache, chills, and flu like symptoms, then the next day the same thing, then later that night a fever, then the next day a fever. He said on Christmas Eve he got a COVID test to rule it out, and the test was negative. He said he was feeling better, then on 27Dec2020 he started feeling sick with a fever, then on 28Dec2020 a low grade fever and feeling rundown. The patient said he had a nasal swab COVID-19 test done, the one with 3-5 days for results. He said that the test itself was done on 24Dec2020. He said that the temperature for his low grade fever was 100.3 degrees Fahrenheit. His question was about the side effects, since he knew that these are listed that they can be side effects. He said it just kind of worries him since he felt better and now he feels sick again and popped a fever. He said that he called his doctor, and they said they are not gonna do a second COVID test, and told him to rest. He said he doesn't think this is normal though. Treatment of the events included Ibuprofen. The patient clarified to Advil. He said he took the recommended dose of two pills, 200 mg each. Advil: UPC: Unknown, Lot: DL9107 EXP: Jan2023. He said he took the Advil maybe once a day, the first two days. The lab test included temperature: 100.3 degrees Fahrenheit in Dec2020 and COVID-19 nasal swab test: negative on 24Dec2020. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 0920137
Sex: F
Age:
State: CA

Vax Date: 12/24/2020
Onset Date: 12/26/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: stomach cramps; diarrhea; chills; This is a spontaneous report from a contactable other healthcare professional. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at left arm on 24Dec2020 08:00 at single dose for Covid-19 immunization. The COVID-19 vaccine was administered in a hospital facility. Medical history included hypertension, and allergic to penicillin. The patient was not diagnosed with Covid-19 prior vaccination. Concomitant medication included amlodipine and irbesartan; both from unspecified date for unspecified indication. On 26Dec2020 22:30, the patient experienced stomach cramps, diarrhea and chills. The patient was not tested for COVID-19 post vaccination. The patient did not receive treatment due to the events. The outcome of the events stomach cramps, diarrhea and chills was recovering. The reporter considered the events non-serious; the events did not results in death, not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, not a congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.

Other Meds: ;

Current Illness:

ID: 0920138
Sex: F
Age:
State: WI

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Date: 20201228; Test Name: Vital signs; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: throat feeling "hot"; tongue feeling numb and thick; tongue feeling numb and thick; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date unknown) intramuscular at left deltoid on 28Dec2020 10:00 at single dose for Covid-19 immunization. The COVID-19 vaccine was administered in the workplace clinic. Medical history included allergies to shellfish, allergies to strawberries, and environmental allergies. Concomitant medications were not reported. On 28Dec2020 10:30 am (approximately 30 min post vaccine), the patient experienced that her throat feeling "hot" and her tongue feeling numb and thick. The patient denied ever feeling short of breath. The patient's vital signs were recorded on 28Dec2020. The patient was not tested for COVID-19 since vaccination. The outcome of the events throat feeling "hot", tongue feeling numb and thick was unknown. The reporter considered the events non-serious; did not results in death, was not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, not a congenital anomaly/birth defect.

Other Meds:

Current Illness:

ID: 0920139
Sex: F
Age:
State: NJ

Vax Date: 12/22/2020
Onset Date: 12/24/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Name: weight; Result Unstructured Data: Test Result:loss

Allergies:

Symptoms: Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Myalgia; headache; anorexia; fatigue; weight loss; sweats; This is a spontaneous report from a contactable physician (patient). A 65 years old years female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EM9899) via an unspecified route of administration at Left arm on 22Dec2020 01:15PM at single dose for COVID-19 immunization. The patient's medical history included hypertension, body mass index (BMI) 30, hypothyroidism and Covid-19. Known allergies: penicillin, sulpha drugs, seasonal allergies. No other vaccine in four weeks. The concomitant was reported as hydrochlorothiazide, losartan potassium (HYZAAR), levothyroxine sodium (SYNTHROID), Metformin. The patient experienced pain, edema and erythema in 4 cm circumference around injection site myalgia, headache, anorexia, fatigue, weight loss, sweats, all started from 24Dec2020. No treatment received for events. The outcome of the events was recovering.

Other Meds: HYZAAR; SYNTHROID;

Current Illness:

ID: 0920140
Sex: M
Age:
State:

Vax Date: 12/20/2020
Onset Date: 12/01/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: rash on his arm/has grown and was now a little bit itchy; This is a spontaneous report from a contactable Physician (patient). A 39-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiry date unknown) intramuscular at right arm on 20Dec2020 around 09:30 at single dose for Covid-19 vaccination. The patient's medical history and concomitant medications were none. The patient received Covid 19 vaccine 8 days ago (20Dec2020 around 09:30) and 5 days ago (Dec2020) he noticed a rash on his arm. The patient informed that he was not even sure if this was about the COVID-19 vaccine or if he has just associated it with it, but the rash has grown and was now a little bit itchy (Dec2020). The patient clarified that his first dose of the COVID-19 vaccine was on 20Dec2020 and he had onset of rash about 23Dec2020 or 24Dec2020, he was not exactly sure. The outcome of the event rash on his arm/has grown and was now a little bit itchy was not recovered. The reporter causality was unknown, with the information he has obtained and the conversation he just had with the inbound transfer agent it seemed a very low, slight likelihood that there was a causality relationship.

Other Meds:

Current Illness:

ID: 0920141
Sex: F
Age:
State: MO

Vax Date: 12/18/2020
Onset Date:
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: the injection site become red and sore; the injection site become red and sore; This is a spontaneous report from a contactable Other HCP (patient). A female patient of an unspecified age received the first dose of BNT162B2 (batch/lot number and expiration date not provided), via an unspecified route of administration, on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the vaccine on 18Dec2020 and did not initially have any side effects but yesterday(8 days after vaccination) the injection site become red and sore on an unknown date. The outcome of the events was unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 0920142
Sex: F
Age:
State: NY

Vax Date: 12/18/2020
Onset Date: 12/01/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Name: Respiratory Panel; Result Unstructured Data: Test Result:Negative; Test Date: 20201224; Test Name: COVID virus; Result Unstructured Data: Test Result:Positive

Allergies:

Symptoms: tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; sinus infection; tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; Her nose being stuffed; tension headache on the back of head; her deltoid was hurting for 24 hours; active infection after getting the first dose; This is a spontaneous report from a contactable pharmacist (patient). A 37-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the right deltoid on 18Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient had active infection after getting the first dose, consult if it was still recommended to get the second dose next week or she should be delaying getting the second dose. The patient got the COVID vaccine on the 18Dec2020. Then on the 24Dec2020 she tested positive for the COVID virus. She was due to get the second vaccine on 08Jan2021. She was asking should she still get the 2nd dose of the vaccine since came up positive. The patient was having a symptom, she lost her sense of smell of 22Dec2020. She lost her sense of smell on the evening on 22Dec2020, it still had not come back at all. She did have sense of taste on the tongue. She thought it was sinus infection, because her head didn't hurt and she was not stuffed anymore. She stated that after the vaccine, she had a tension headache on the back of head, and her deltoid was hurting for 24 hours. Her headache started the same day in the evening, went on till lunch time next day. Her nose being stuffed which she thought was a sinus infection started on Tuesday 22Dec2020, it was more located in the front middle of her forehead. Her nose being stuffed which she thought was a sinus infection started on Tuesday 22Dec2020, it was more located in the front middle of her forehead. She did not have her Card to provide Lot and Expiry, it was at work at the hospital. She was administered the vaccine on the right deltoid, since she didn't want to sleep on it. Prior to vaccine she has had no positive test for Covid. Caller stated that this was super unfortunately coincidental. She had had no antibody test. She had no reactions to vaccines in the past. Test: Respiratory Panel. Result: Negative on unknown date. The outcome of events drug ineffective, COVID-19 and sinus infection was not recovered. The outcome of event tension headache and muscle pain was recovered in Dec2020. The outcome of rest events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the reported events of LOE, COVID 19 and other events, based on temporal relationship. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information.

Other Meds:

Current Illness:

ID: 0920143
Sex: F
Age:
State: AL

Vax Date: 12/16/2020
Onset Date: 12/01/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Name: blood work; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201218; Test Name: temperature; Result Unstructured Data: Test Result:98.8; Comments: she had temperature of 98.8 which is low grade fever for her because she runs low

Allergies:

Symptoms: generally not feeling well; a low grade fever; chills; freezing; couldn't get warm; tired and run down; sleepy; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EK5730), via an unspecified route of administration on 16Dec2020 08:40 AM at right deltoid, at single dose for covid-19 immunization. Medical history included sleep disorder. Concomitant medication included alprazolam prn (as needed) for sleep, HCTZ; losartan; metoprolol; montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL). On 18Dec2020 the patient had temperature of 98.8 which is low grade fever for her because she runs low. On 18Dec2020, she experienced a low grade fever, chills and was freezing. On 18Dec2020 she had chills and couldn't get warm. She had three layers on and a heating vest. It passed and she was doing fine. Those symptoms passed, but reappeared on 26Dec2020, last Saturday. Since then, she mentioned generally not feeling well, in addition to being freezing cold and experiencing chills every day. She had been monitoring her temperatures, and had no fever. Since 26Dec2020, she had chills, couldn't get warm, and no fever. She was tired and run down. She was sleepy and usually she was very energetic. The patient asked if have heard of such experience in other people. Seriousness Criteria was reported as it was not disabling, but annoying. It was unusual. She had on a thermal shirt that she would wear for skiing and that is not normal. Then on the 26Dec2020 the chills started back again. She felt kind of tired. She didn't feel sick, but not up to snuff. No AE required emergency room/physician office. The outcome of the event fever was recovered on 19Dec2020. The outcome of the events freezing; sleepy; tired and run down was unknown. The outcome of the other events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.

Other Meds: ; HCTZ; ; ; SINGULAIR; XYZAL

Current Illness:

ID: 0920144
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: arm pain/soreness; This is a spontaneous report from a non-contactable nurse reported for herself. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiry date unknown) via an unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain/soreness on unspecified date. The outcome of the event arm pain/soreness was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 0920145
Sex: F
Age:
State: CA

Vax Date: 12/22/2020
Onset Date: 12/23/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: L armpit swollen; L armpit lymph nodes swollen; Sensation of heaviness left arm; painful scapular area; This is a spontaneous report from a contactable other health professional (patient). A 44-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/ Lot number: eh9899), intramuscularly on 22Dec2020 12:30 at single dose on left arm for COVID-19 immunization in hospital. Medical history included ongoing hypertension, allergic to shellfish. Concomitant medication within 2 weeks of vaccination included losartan, hydrochlorothiazide, vitamin C [ASCORBIC ACID], colecalciferol (VITAMIN D), zinc, paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced L armpit swollen/ L armpit lymph nodes swollen, sensation of heaviness left arm and painful scapular area from 23Dec2020 15:30. No treatment received for the adverse events. The outcome of events was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.

Other Meds: ; ; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; ; TYLENOL

Current Illness: Hypertension

ID: 0920146
Sex: F
Age:
State: CO

Vax Date: 12/17/2020
Onset Date: 12/01/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: Test Date: 20201224; Test Name: tested; Test Result: Positive

Allergies:

Symptoms: tested positive; tested positive; Symptoms experiencing include having no taste, smell and slight bodyache; Symptoms experiencing include having no taste, smell and slight bodyache; Symptoms experiencing include having no taste, smell and slight bodyache; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable other-healthcare professional (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive on 24Dec2020, and symptoms experiencing include having no taste, smell and slight body ache in Dec2020. The patient asked if she could get the second dose. The outcome of the events was unknown. Information about the Lot/batch number has been requested.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the COVID-19, with symptoms of having no taste, smell and slight body ache, and vaccination with BNT162B2 cannot be excluded.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm