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: 0947545
Sex: F
Age:
State: NH

Vax Date: 01/07/2021
Onset Date: 01/09/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nausea; vomiting; dizziness with vertigo; dizziness with vertigo; headache; fever; severe body aches in lower back; fatigue; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246), via intramuscular on 07Jan2021 11:45 at single dose in left arm for covid-19 immunization. Medical history included asthma, hospitalized with pertussis related bronchiolitis/hypoxia in Apr2020. The patient's concomitant medications received within 2 weeks of vaccination included multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had allergies to medications, food, or other products included erythromycin and pancuronium bromide (PAVULON). The patient previously received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), via intramuscular on 17Dec2020 17:00 at single dose in right arm for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The patient experienced nausea, vomiting, dizziness with vertigo, headache, fever, severe body aches in lower back and fatigue from 36 to 50 hours post vaccination on 09Jan2021. The patient did not receive any treatments. The outcome of the events was recovered in Jan2021.

Other Meds:

Current Illness:

ID: 0947546
Sex: F
Age:
State: AL

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data: Test Date: 20201228; Test Name: Nasal swab covid test; Test Result: Negative

Allergies:

Symptoms: Body aches; fever; chills; headache; This is a spontaneous report from a contactable other health professional (patient). A 35-year-old female patient (no pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: El1283) via an unspecified route of administration on the left arm on 08Jan2021 02:00 PM at single dose for COVID-19 immunisation. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ek5730) via an unspecified route of administration on the left arm on 18Dec2020 03:45 PM at single dose for COVID-19 immunisation. Medical history included known allergy to Bactrum and ciprofloxacin hydrochloride monohydrate (CIPRO). The patient's concomitant medications included bupropion hydrochloride (WELLBUTRIN) and lisdexamfetamine mesilate (VYVANSE). No other vaccine in four weeks. On 09Jan2021 at 04:00 AM, patient experienced body aches, fever, chills, headache. Nasal swab covid test post vaccination on 28Dec2020 was negative. No treatment received for the events. The outcome of events was unknown.

Other Meds: WELLBUTRIN; VYVANSE

Current Illness:

ID: 0947547
Sex: F
Age:
State: OR

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data: Test Name: BP; Result Unstructured Data: Test Result:maintained; Test Name: EKG; Result Unstructured Data: Test Result:sinus tachycardia.; Test Name: HR; Result Unstructured Data: Test Result:156; Test Name: HR; Result Unstructured Data: Test Result:One episode in ED with HR 151.; Test Name: Labs; Result Unstructured Data: Test Result:unremarkable

Allergies:

Symptoms: Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a contactable Physician (Patient). A 48-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EK9231), via an unspecified route of administration on 07Jan2021 13:15 at single dose in Left arm for COVID-19 immunization. Medical history included hypothyroidism, breast cancer and severe local/regional reaction to bee sting. The patient previously took tamoxifen for breast cancer (9-10 years before 10Jan2021). There were no known allergies. Concomitant medications which the patient received within 2 weeks of vaccination included levothyroxine, tamoxifen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced uneasiness, tingling followed by tachycardia within couple of minutes, some abdominal queasiness on 07Jan2021 13:15. Heart rate (HR) was 156. Seemed to subside over a period of 30 minutes. However slow waves of similar episodes occurred throughout the rest of the day, predominantly tachycardia and Gastrointestinal tract. Next day symptoms recurred and sustained a little longer. Sought evaluation. In Emergency department (ED), Labs unremarkable. One episode in ED with HR 151. Blood pressure (BP) maintained. Electrocardiogram (EKG) showed sinus tachycardia. Treated with steroids and Benadryl. On pulse dose steroids and Benadryl with overall improvement. The events resulted in Emergency room/department or urgent care. Treatments Solumedrol and Benadryl were received for the reported events. The outcome of the events was Recovering. This case reported as non-serious.

Other Meds: ;

Current Illness:

ID: 0947549
Sex: F
Age:
State: CA

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 01/15/2021
Hospital:

Lab Data: Test Date: 20210104; Test Name: Covid-19 PCR Test; Test Result: Negative ; Test Date: 20210107; Test Name: Covid-19 PCR Test; Test Result: Negative ; Test Date: 202101; Test Name: Covid-19 PCR Test; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: partial complex seizure; I lost muscle tone and collapsed; severe LUE weakness; severe pain; aura; I lost muscle tone and collapsed; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 40-year-old female not pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 30Dec2020 h 05:00 PM at single dose for COVID-19 immunisation, lot number: EH9899. Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included epilepsy (well controlled with medications) and she was allergic to phenytoin (DILANTIN). Concomitant medications in two weeks prior to the vaccination included carbamazepine, lamotrigine (LAMICTAL) and fluoxetine. It was reported that on 31Dec2020 h 14:00 (also reported as approximately 22 hours after vaccine) patient experienced severe left upper extremity (LUE) weakness and severe pain. She then experienced an aura and had a partial complex seizure. Patient lost muscle tone and collapsed. The episode lasted approximately 1.5 minutes, no treatment was given. Patient was tested for Covid post vaccination, she underwent Covid-19 PCR Test (Nasal Swab) on 04Jan2021 and on 07Jan2021, both with negative results. She also underwent a Covid-19 PCR Test on unknown unknown date in Jan2021 with unknown results. Patient recovered on 31Dec2020 from the events.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product event most likely due to patient underlying contributory factors. 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: ; LAMICTAL;

Current Illness:

ID: 0947550
Sex: F
Age:
State: ID

Vax Date: 12/18/2020
Onset Date: 12/18/2020
Rec V Date: 01/15/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: spontaneous rupture of membranes at 36-0 weeks; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable physician. This physician reported information for both mother and fetus/baby. This is the maternal report. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (left arm) on 18Dec2020 and 08Jan2021 at a single dose for COVID-19 immunization. Medical history included cold sores, no active cold sore at time of labor. On an unspecified date, it was reported that a healthy 29-year-old G1P0 with good prenatal care and no pregnancy complications who had spontaneous rupture of membranes at 36-0 weeks, one day after her second Pfizer CoVid vaccine (09Jan2021). She felt well after her vaccine and had no symptoms today. The mother reported she became pregnant while taking BNT162B2. The patient takes prenatal vitamins. The mother was 33 Weeks pregnant at the onset of the event. The mother was due to deliver on 06Feb2021. Therapeutic measures were taken as a result of premature rupture of membranes. The outcome of the event was recovering. Information about Batch/Lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of spontaneous rupture of membranes due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0947551
Sex: F
Age:
State: WA

Vax Date: 01/08/2021
Onset Date:
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Increase bowel movements; fever; body ache; injection site pain; intermittent moderate headache; fatigue; weakness; feeling unwell; This is a spontaneous report from a contactable other HCP (patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 15:00 at single dose on arm left for covid-19 immunisation. Medical history reported as none. Pregnant at the time of vaccination: No. Unknown if COVID prior vaccination. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced Increase bowel movements, fever, body ache, injection site pain, intermittent moderate headache, extreme fatigue, mild weakness, feeling unwell, all reported from 01Jan2021 07:00 PM (pending clarification). Treatment received for all the events included OTC ibuprofen. Outcome of events was recovering. No COVID tested post vaccination. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0947552
Sex: F
Age:
State: CA

Vax Date: 12/20/2020
Onset Date: 12/20/2020
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Within 15 minutes, I began feeling dry throat; Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside my throat.; it felt like I had a lump inside my throat.; Then I began to have difficulty swallowing my saliva.; difficulty breathing; very groggy; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), intramuscular in left arm on 20Dec2020 at a single dose for COVID-19 immunization. Vaccination was administered in a hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included hypertension, overweight, and known allergies to bee stings and hair dye. The patient's concomitant medication included multivitamins. On 20Dec2020, within 15 minutes, the patient began feeling dry throat, then itching, then it felt like she had a lump inside her throat. Then she began to have difficulty swallowing her saliva. And then the lump inside her throat started to feel larger and larger. By this time, the doctor had already injected the patient with Epipen and the pharmacist injected her with Solumedrol and she still felt as if she was having difficulty breathing and then she was taken to ER and she really can't remember too much after that. The patient was very groggy and then was discharged from ED about 9:30 pm. The outcome of the events was recovered on an unknown date. Treatment for the events included epinephrine, methylprednisolone, diphenhydramine. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling dry throat, itching, felt like having lump inside her throat, having difficulty swallowing saliva, difficulty breathing and very groggy cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. 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: 0947553
Sex: F
Age:
State: CO

Vax Date: 01/09/2021
Onset Date: 01/10/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data: Test Date: 20210110; Test Name: Swelling measuring; Result Unstructured Data: Test Result:size of a ping pong ball.

Allergies:

Symptoms: significant swelling to lymph nodes under armpit of injection side (L arm); This is a spontaneous report from a contactable consumer. A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at the left arm on 09Jan2021 08:00 at SINGLE DOSE for COVID-19 immunization at a hospital. Medical history included asthma, food allergy with peanuts and pine nuts. No known medication allergy. The concomitant medications included albuterol and unspecified multivitamin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) at the left arm on 19Dec2020 08:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient was not pregnant. On 10Jan2021 16:00, the patient noted significant swelling to lymph nodes under armpit of injection side, swelling in the left armpit lymph nodes began approximately 32 hours after injection. Swelling measuring approximately size of a ping pong ball. At time of this reporting (approximately 40 hours post-injection) lymph node swelling still persists, with no change in size. The patient did not receive any treatment for the events. The patient has not recovered from the events. No follow-up attempts are needed. No further information expected.

Other Meds: ALBUTEROL [SALBUTAMOL]

Current Illness:

ID: 0947554
Sex: M
Age:
State: NV

Vax Date: 12/17/2020
Onset Date: 12/21/2020
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: numbness to left little toe; This is a spontaneous report from a contactable physician. A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration, at the left arm on arm on 17Dec2020 10:15 at single dose for COVID-19 immunization at a hospital. Medical history included prostatitis. No known drug allergy. Concomitant medication included clindamycin hcl. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020 08:00, a few days after first shot patient noticed numbness to left little toe. This progressed slowly to 3rd and 4th digit. After second shot (day 2), patient noticed this now extended to both feet, digits 3-5, sole of feet, and outside edge of feet. No pain just numbness. The patient was not tested for it since the vaccination. The patient took the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), on 07Jan2021 at the left arn for COVID-19 immunization. The patient did not received any treatment for the event. The patient has not recovered from the event.

Other Meds: CLINDAMYCIN HCL

Current Illness:

ID: 0947555
Sex: F
Age:
State: TX

Vax Date: 01/10/2021
Onset Date: 01/10/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Injection site soreness that developed to arm soreness with both doses.; Injection site soreness that developed to arm soreness with both doses.; This is a spontaneous report from a contactable nurse, the patient. A 43-year-old non-pregnant female patient received the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), via unspecified route of administration in the right arm on 10Jan2021 at 14:45 PM (at the age of 43-year-old) as a single dose; the patient previously received the first dose of BNT162B2, Lot number: EK5730), via unspecified route of administration in the left arm on 20Dec2020 at 12:30 PM (at the age of 43-year-old) as a single dose; both for COVID-19 immunization. Medical history included asthma, obesity, hypothyroidism, hypoglycaemia, attention deficit hyperactivity disorder. The patient had allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included ibuprofen, liraglutide (SAXENDA). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jan2021 at 20:00 PM, the patient experienced injection site soreness that developed to arm soreness with both doses. The events were reported as non-serious. The patient did not receive any treatment for the injection site soreness that developed to arm soreness with both doses. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events injection site soreness that developed to arm soreness with both doses was recovering.

Other Meds: ; SAXENDA

Current Illness:

ID: 0947556
Sex: F
Age:
State: TX

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data: Test Date: 20201228; Test Name: Nasal Swab; Test Result: Positive

Allergies:

Symptoms: Lymphadenopathy; This is a spontaneous report from a contactable healthcare professional who reported for herself, a 40-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: el0142) at the hospital, intramuscular in the left arm on 06Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical history included "COVID prior vaccination Yes" on an unspecified date. The patient was not pregnant at the time of reporting. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 with lot number: EK7530 at age 40 years, via intramuscular route in the left arm, on 16Dec2020 at 12:00 PM, Nasal Swab test result was positive on 28Dec2020. The patient experienced lymphadenopathy on 07Jan2021 at 19:00. The event was considered as non-serious. No treatment was received for the adverse event. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 0947557
Sex: F
Age:
State: TX

Vax Date: 12/16/2020
Onset Date: 12/28/2020
Rec V Date: 01/15/2021
Hospital:

Lab Data: Test Date: 20201228; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Positive

Allergies:

Symptoms: Patient was tested for Covid post vaccination/ Covid test on 28Dec2020 and resulted positive; Patient was tested for Covid post vaccination/ Covid test on 28Dec2020 and resulted positive; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK7530) solution for injection, intramuscular on left arm on 16Dec2020 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. It was reported that patient was tested for Covid post vaccination. Nasal swab for Covid test was done on 28Dec2020 and resulted positive. Outcome of the event was unknown. No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.

Other Meds:

Current Illness:

ID: 0947559
Sex: F
Age:
State: WI

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: had a metallic taste; turned to swollen tongue; hives around chest and neck; difficult to breathe; tachycardia; This is a spontaneous report from a contactable other HCP (Patient). A 33-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL 3248), via an unspecified route of administration at right arm on 07Jan2021 16:15 at single dose for covid-19 immunization. Vaccine was administered at hospital. Known allergies included cyclobenzaprine and dairy latex. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 10 mg, gabapentin 300 mg, venlafaxine 150 mg. No other vaccine in four weeks. Three minutes after vaccination the patient had a metallic taste, turned to swollen tongue, hives around chest and neck, difficult to breathe, and tachycardia on 07Jan2021 16:18. The events resulted in Emergency room/department or urgent care. Treatment received included Epinephrine, methylprednisolone sodium succinate (SOLU-ME dork) and famotidine (PEPCID) also diphenhydramine HCl (BENADRYL). The outcome of the events was unknown.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for events metallic taste, swollen tongue, hives, difficulty breathing and tachycardia. 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: ADDERALL; ;

Current Illness:

ID: 0947560
Sex: F
Age:
State: IL

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 4 hours after vaccine, soreness at injection site; severe whole body chills; whole body aches; This is a spontaneous report from a contactable other hcp. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, intramuscular on the left arm on 07Jan2021 17:45 at a SINGLE DOSE and intramuscular on the left arm on 17Dec2020 18:45 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. Concomitant medication included escitalopram oxalate (LEXAPRO). On 07Jan2021, it was reported that 4 hours after vaccine, there was soreness at injection site. 14 hours following vaccine, the patient experienced sudden onset of severe whole body chills and whole body aches lasting up to 18 hours. The outcome of the events was recovered. Information on the lot/ batch number has been requested.

Other Meds: LEXAPRO

Current Illness:

ID: 0947561
Sex: M
Age:
State: NY

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fatigue; fever; headache; This is a spontaneous report from a contactable nurse. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number:Ek9231, via an unspecified route of administration on the left arm on 08Jan2021 22:30 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included paroxetine (PAROXETINE), finasteride (FINASTERIDE), testosterone (TESTOSTERONE) and rosuvastatin calcium (ROSUVASTATIN VIAL). The patient experienced fatigue, fever and headache on 09Jan2021 11:00 with outcome of recovered.

Other Meds: ; ; ; ROSUVASTATIN VIAL

Current Illness:

ID: 0947562
Sex: F
Age:
State: NC

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: I have swelling and pain in my underarm on the same side as my shot. My arm is still sore. But the swelling has not decreased . Started Saturday morning after my 2nd vaccine dose Friday night.; I have swelling and pain in my underarm on the same side as my shot. My arm is still sore. But the swelling has not decreased . Started Saturday morning after my 2nd vaccine dose Friday night.; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on left arm on 08Jan2021 19:00 at a single dose for Covid-19 immunization. Medical history included lymphoma, and red food coloring allergy. The patient received her first dose of BNT162B2 on 22Dec2020. The patient's concomitant medications were not reported. The patient reported she had swelling and pain in her underarm on the same side as her shot. Her arm was still sore, and the swelling has not decreased. It started Saturday morning (09Jan2021 at 6am) after her 2nd vaccine dose on Friday night. It was unknown if patient received any treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered. Information about Lot/Batch number is requested.

Other Meds:

Current Illness:

ID: 0947563
Sex: M
Age:
State:

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data: Test Name: temperature; Result Unstructured Data: Test Result: Unknown results; Test Name: pulse; Result Unstructured Data: Test Result: Unknown results

Allergies:

Symptoms: more stiffness at the vaccination site; tiredness/fatigue; slight bleeding after the injection; when lifting my left arm/It felt heavier; pain at the time of syringe injection; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 06Jan2021 13:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Dec2020 for COVID-19 immunization and experienced vaccination site pain, vaccination site stiffness and vaccination site movement impairment. The patient completed the second administration and had finalized his vaccination process. At first vaccine administration the patient mentioned it was no different from regular influenza vaccine. There was no special side effect. The patient woke up in the morning and there was pain at the time of syringe injection the same as 1st administration but there wasn't much feeling of the syringe being injected. After the administration, the patient was watched for around 30 minutes, but had no specific allergic reaction, just like the 1st administration. When he woke up this morning, and also in the evening of the vaccination day, although it is not sure if it is due to the vaccine, the patient had tiredness. His wife and child checked body temperature and pulse every 30 minutes. At the time of report, the patient woke up slightly early, but anyhow the difference was feeling of tiredness. Also there was more stiffness at the vaccination site that was felt more strongly than at 1st vaccination, especially when lifting left arm compared to the first vaccination. It felt heavier and sorer. The patient is feeling better and without any pain now. When talked about the second vaccination that he received, the patient look as though he was in pain when receiving it and reporter replied yes, slightly. At 1st administration there was no bleeding after the injection. But at 2nd administration there was slight bleeding after the injection so the patient was surprised. In summary, the patient had pain at injection with the syringe at 2nd administration,when the syringe was injected and also had pain a little after the injection, other than that, he had no special side effect. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 0947564
Sex: M
Age:
State: NC

Vax Date: 01/07/2021
Onset Date: 01/09/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Rash lower back, itching on back, leg, lower stomach.; Rash lower back, itching on back, leg, lower stomach.; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) solution for injection, via an unspecified route of administration on left arm on 07Jan2021 17:15 at a single dose for COVID-19 immunization. Medical history included hypertension, kidney disease stage 3, UTI (urinary tract infection), enlarged prostate, and known allergy to penicillin. Concomitant medication included amlodipine, benazepril, tamsulosin, ergocalciferol (VIT D), and unspecified multivitamin. The patient experienced rash lower back, itching on back, leg, lower stomach on 09Jan2021 at 2pm. No treatment received. The events were reported as non-serious. The patient was not diagnosed with Covid-19 prior to vaccination. The patient has not been tested for Covid-19 since the vaccination. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: ; ; ; VIT D

Current Illness:

ID: 0947566
Sex: F
Age:
State: NJ

Vax Date: 01/07/2021
Onset Date: 01/10/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: chills; stomach cramps; watery diarrhea all day and through the evening; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EK9231 and expiry date unknown) via an unspecified route of administration in the left arm on 07Jan2021, 12:15PM at a single dose for COVID-19 immunization. The patient's medical history included allergy to scallops. Concomitant medications included metoprolol, omeprazole, simvastatin, magnesium chloride (SLOW MAG), and colecalciferol (VITAMIN D); patient also receive these medications within 2 weeks of vaccination. The patient had previous allergies with Erythromycin. The patient was not pregnant; did not receive any other vaccines within 4 weeks prior to BNT162B2; and was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On Sunday, 10Jan2021, 1200AM, reported as three days after vaccine, the patient developed chills, stomach cramps, and watery diarrhea all day and through the evening. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovering. The report was considered as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.

Other Meds: ; ; ; SLOW MAG [MAGNESIUM CHLORIDE]; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 0947567
Sex: F
Age:
State: CT

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/15/2021
Hospital:

Lab Data: Test Date: 20201224; Test Name: Body temperature; Result Unstructured Data: Test Result:99.8

Allergies:

Symptoms: arm was sore; pounding headache; ear ache; checked her temp and it was 99.8; felt hot and then cold at times; within minutes she felt like she had a knot on her throat; This is a spontaneous report from a contactable health care professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EH9899) in the hospital via intramuscular route on 23Dec2020 at 13:45 at a single dose on the right arm for COVID-19 immunization. Medical history included seasonal allergy, allergy to latex and an allergic reaction to something she ate and by the time they did the allergy test, they could not find what it was. The patient carried an EpiPen for years. The patient's concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient was not administered any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient got the shot and within minutes she felt like she had a knot on her throat, the nurse assisted and gave her water. They kept her for 30 minutes on observation. She was fine after that and next day, her arm was sore, she had a pounding headache, ear ache and checked her temp and it was 99.8 (unit not specified) and she felt hot and then cold at times all on 24Dec2020 at 13:00. She took Motrin 600mg and it helped out. The outcome of the events was recovered. The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 0947568
Sex: F
Age:
State: AR

Vax Date: 12/31/2020
Onset Date: 01/11/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Injection site redness; rash on arm near injection site; fever in arm; chills; nausea; This is a spontaneous report from a contactable other health care professional. A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EJ1686), intramuscular on 31Dec2020 07:30 at single dose at arm left for COVID-19 immunization. Medical history included GERD, ovarian cysts, obesity, and anxiety. Concomitant medications included fluoxetine, omeprazole, and folic acid. On 11Jan2021 07:00, the patient experienced Injection site redness, rash on arm near injection site, fever in arm, chills, nausea. The patient did not receive treatment for the events. The outcome of the events was recovering.

Other Meds: ; ;

Current Illness:

ID: 0947569
Sex: F
Age:
State: TN

Vax Date: 01/07/2021
Onset Date: 01/10/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: severely sore arm; injured a ligament in the shoulder; Unable to lift arm; pain in shoulder and muscle; pain in shoulder and muscle; This is a spontaneous report from a contactable other healthcare professional (hcp). A 26-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry date not reported), intramuscular on 07Jan2021 08:45 at a single dose in the left arm for COVID-19 immunization. Medical history included allergic to tree nuts and patient had COVID prior to vaccination. The patient was not pregnant at the time of the vaccination. Concomitant medication included tetanus vaccine on 02Jan2021 at a single dose. The patient had no other medications in two weeks. On 10Jan2021, the patient experienced severely sore arm as well as feeling as though patient injured a ligament in the shoulder. The patient was unable to lift arm without pain in shoulder and muscle. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Treatments was not received in response to the events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events severely sore arm, injured a ligament in the shoulder, unable to lift arm, and pain in shoulder and muscle. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0947570
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/15/2021
Hospital:

Lab Data: Test Name: COVID-19 test; Result Unstructured Data: Test Result:has not tested positive

Allergies:

Symptoms: exposed to COVID; runny nose; This is a spontaneous report from a Pfizer-sponsored Program. A contactable nurse (patient) reported that a female patient (age: 68, unit: unknown) received the 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 an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of vaccine and is asking if she can receive the second dose of vaccine after being exposed to COVID. She has not tested positive on an unspecified date. She does have a runny nose, and this is not uncommon for her. Patient asked "If I do get symptoms of COVID, what do I do? Can I get the second dose? How long is recommended quarantine after exposure to COVID-19? Can I get the second dose later than the 3-week mark? since her second dose is scheduled for tomorrow. Outcome of the events was unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 0947571
Sex: M
Age:
State: IN

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Became very light headed; cold chills with shaking for 45-60 minutes; cold chills with shaking for 45-60 minutes; Sweating for next 12 hours; Date of start of drug: 08Jan2021, Dose number: 2; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm, on 08Jan2021 08:30, at single dose, for COVID-19 immunization, in the doctor's office/urgent care. Medical history included depression, anxiety and COVID-19, all on unspecified dates. The patient has no known allergies. Concomitant medication included vilazodone hydrochloride (VIIBRYD 40 mg) and folic acid 1 mg. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm, on 19Dec2020 12:30, at single dose, for COVID-19 immunization. On 08Jan2021 at 21:00 (reported as 12 hours after the shot), the patient became very light headed. He experienced cold chills with shaking for 45-60 minutes and was sweating for next 12 hours. The patient had no fever. All events subsided by 10:00 next day, 09Jan2020. The patient received no treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 09Jan2020 at 10:00.

Other Meds: VIIBRYD;

Current Illness:

ID: 0947572
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/15/2021
Hospital:

Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: tested positive; Comments: tested positive after receiving first dose of vaccine

Allergies:

Symptoms: tested (COVID-19 virus test) positive after receiving first dose of vaccine; tested (COVID-19 virus test) positive after receiving first dose of vaccine; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that patient tested (COVID-19 virus test) positive after receiving first dose of vaccine. It was also reported that they are looking for administration recommendations following receipt of monoclonal antibodies and interval information. Outcome of the events was unknown. Information of the lot number/batch number was requested.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.

Other Meds:

Current Illness:

ID: 0947573
Sex: F
Age:
State: FL

Vax Date: 01/04/2021
Onset Date:
Rec V Date: 01/15/2021
Hospital:

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:202/104

Allergies:

Symptoms: really extreme high blood pressure (202/104); feeling very sick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 04Jan2021 at a single dose for COVID-19 immunization. Medical history included strokes and bleeding disorder (gene that makes blood clot). The patient's concomitant medications were not reported. The patient experienced really extreme high blood pressure (202/104) and feeling very sick on an unspecified date. The clinical course was reported as: The patient received the vaccine on 04Jan2021 and experienced a lot of side effects, the most concerning of which was really extreme high blood pressure. The patient went to the emergency room (ER) on an unspecified date and her blood pressure was 202/104 on an unspecified date. The patient stated that she had been very sick and in bed for days. The patient had a follow-up appointment with her doctor on the day of the report. The clinical outcome of really extreme high blood pressure (202/104) and feeling very sick was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.

Other Meds:

Current Illness:

ID: 0947574
Sex: F
Age:
State: WA

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: light headed (airy/helium head feeling); hard to concentrate on more than one task at a time; Flushed; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular on 22Dec2020 at 11:30 at a single dose on the left arm for COVID-19 immunization in a workplace clinic. Medical history was reported as none. The patient's concomitant medications were not reported. The patient had no known allergies. The patient also did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Dec2020 at 15:00, the patient was light headed (airy/helium head feeling), hard to concentrate on more than one task at a time, and flushed. No treatment was given to the patient. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on an unspecified date. The events were considered non-serious. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 0947576
Sex: M
Age:
State: WI

Vax Date: 12/17/2020
Onset Date: 01/01/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache, body ache, lethargic. Ended up falling asleep and sleeping for 13 hours. Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; Headache, body ache, lethargic. Ended up falling asleep and sleeping for 13 hours. Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; Headache, body ache, lethargic. Ended up falling asleep and sleeping for 13 hours. Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; Headache, body ache, lethargic. Ended up falling asleep and sleeping for 13 hours. Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; Headache, body ache, lethargic. Ended up falling asleep and sleeping for 13 hours. Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; This is a spontaneous report from a contactable other health care professional (patient). A 35-year-old male patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ek5730 expiration date not provided), intramuscular (arm left) first dose on 17Dec2020 13:00 at single dose for covid-19 immunisation. There were no medical history. The patient concomitant medication includes Multivitamin. On 01Jan2021, the patient experienced Headache, body ache, lethargic. Ended up falling asleep and sleeping for 13 hours. Woke up to extremely enlarge lymph nodes under left arm that continues 3 days after first seeing it. No treatment was given for the events. The outcome of the events was recovering. On 07Jan2021 01:15 the patient received second dose intramuscular (arm left) at single dose (lot number EL1283 and expiration date not provided) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). Facility where the most recent COVID-19 vaccine was administered in the Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination the patient did not tested positive for COVID-19. Also, patient did not test positive prior vaccination.

Other Meds:

Current Illness:

ID: 0947577
Sex: M
Age:
State: IL

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data: Test Date: 202009; Test Name: COVID-19; Test Result: Positive

Allergies:

Symptoms: Muscle ache; fever; This is a spontaneous report from a contactable consumer (parent). A 29-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization in a hospital. Medical history included patient was positive for COVID-19 from Sep2020 to an unknown date. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) on an unspecified date. It was unknown if the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Jan2021, the patient experienced muscle ache and fever. The patient was given ibuprofen as treatment for the events. The patient underwent lab test which included COVID-19 test: positive in Sep2020. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Jan2021. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0947578
Sex: F
Age:
State: IL

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Chills; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via an unspecified route of administration on 08Jan2021 11:45 AM at single dose on the right arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), on 18Dec2020 12:00 PM on right arm. COVID-19 vaccine was administered in the hospital. The patient experienced chills, nausea and headache on 09Jan2021 01:30 AM. No treatment received for the events. The events were assessed as non-serious. Outcome of the events was recovered in Jan2021. The patient has not been tested for COVID-19 since the vaccination.

Other Meds:

Current Illness:

ID: 0947579
Sex: F
Age:
State: NJ

Vax Date: 12/26/2020
Onset Date: 12/30/2020
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Right swollen painful lump in armpit; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration on 26Dec2020 17:00 (reported as 5:00 PM) at single dose on the right arm for COVID-19 immunisation. Medical history included asthma, thyroid cancer 2 years ago (2019) and shellfish allergies. The patient's concomitant medications were not reported. The patient previously took gadoxetate disodium (EOVIST) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. COVID-19 vaccine was administered in the hospital. The patient experienced right swollen painful lump in armpit on 30Dec2020. It was unknown if treatment was received. The event resulted in doctor or other healthcare professional office/clinic visit. The event was assessed non-serious. Outcome of the event was recovered with sequel on an unspecified date (reported as "Recovered with lasting effects"). The patient has not been tested for COVID-19 since the vaccination. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0947580
Sex: F
Age:
State: PA

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: fatigue the next day; sudden onset of chills/shaking; severe abdominal cramping and vomiting; severe abdominal cramping and vomiting; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL3246), via an unspecified route of administration on the left arm on 07Jan2021 13:30 at SINGLE DOSE for COVID-19 immunization at the hospital. The patient had allergies with penicillin and sulfa drugs. The patient's concomitant medications were not reported. On 07Jan2021 22:30 (9 hours after vaccine), the patient had sudden onset of chills/shaking , severe abdominal cramping and vomiting which lasted about 1 hr 15 min and then resolved on 07Jan2021 23:45. It was reported that the patient had no other effects than fatigue the next day (08Jan2021). Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events. Outcome of the event of fatigue was unknown while remaining events recovered on 07Jan2021 23:45.

Other Meds:

Current Illness:

ID: 0947581
Sex: M
Age:
State: TX

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch.; Dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch.; Dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch.; Left shoulder and arm pain; arm pain; This is a spontaneous report from a contactable pharmacist (patient). A 48-year-old male patient received the second dose of BNT162B2 (Lot number: EL1283), via an unspecified route of administration from 09Jan2021 08:30 at single dose in the left arm for COVID-19 immunization. Historical vaccine included BNT162B2 (Lot number: EH9899), received first dose via an unspecified route of administration on 19Dec2020 10:45 at single dose in the left arm for COVID-19 immunization. There were no medical history. Concomitant medication included ibuprofen on 11Sep2020 11:00. On 09Jan2021 09:00, the patient experienced dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch. Left shoulder and arm pain. Did not alleviate as of 10Nov2020 when report submitted. No treatment received for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 0947583
Sex: M
Age:
State: NY

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

Lab Data: Test Date: 20210105; Test Name: discomfort; Result Unstructured Data: Test Result:2 out of 10; Test Date: 20210110; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; injection site pain; Mild discomfort (2 of 10), but different than arm/injection site pain; This is a spontaneous report from a contactable other healthcare professional (hcp). A 31-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EJ1686; 313,121, expiry date not reported) via an unspecified route of administration on 05Jan2021 15:30 at a single dose in the left arm for COVID-19 immunization. Medical history included patient had known allergies to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen (ADVIL) at regular dose, 2 pills, one time in 2 weeks. On 05Jan2021 08:00, the patient experienced left hand tingly/achy/numbness, localized but radiant throughout hand and digits, on-and-off throughout day for past 6 days; mild discomfort (2 of 10), but different than arm/injection site pain, which lasted for 2-3 days. The vaccination was done in a hospital. Patient had a nasal swab test post vaccination (COVID-19 Antigen) on 10Jan2021 and the result was negative. No treatments received in response to the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The events injection site pain and "mild discomfort (2 of 10), but different than arm/injection site pain" were recovered in Jan2021. The outcome of the event "left hand tingly/achy/numbness, localized but radiant throughout hand and digits" was not recovered.

Other Meds: ADVIL [IBUPROFEN]

Current Illness:

ID: 0947584
Sex: F
Age:
State: VA

Vax Date: 12/30/2020
Onset Date: 01/07/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Swollen lymph node above collar bone on right side; This is a spontaneous report from a contactable other hcp (patient). A 41-year-old female patient received the first dose of BNT162B2 (lot number: ER5730), via an unspecified route of administration on 30Dec2020 08:30 at single dose in the right arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included metformin. The patient experienced swollen lymph node above collar bone on right side on 07Jan2021. The patient did not receive any treatment for the event. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The vaccine was given in the Hospital. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 0947585
Sex: F
Age:
State: MA

Vax Date: 01/06/2021
Onset Date: 01/01/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: temperature; Result Unstructured Data: Test Result:I am fine; Comments: I take my temperature and I am fine.

Allergies:

Symptoms: lightheaded/dizzy; nauseous; fatigued; feels like hot flashes; feel lousy/don't feel well overall; This is a spontaneous report from a contactable consumer. This consumer reported for herself that the 57-year-old female patient who received first dose of bnt162b2 (BNT162B2, Pfizer-Biontech Covid-19 Vaccine) , via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The consumer reported that "COVID19 vaccine: Are these side effects and wondering about second dose? I had gotten the Pfizer COVID vaccine on 06Jan2021. Yesterday (10Jan2021), I was lightheaded, dizzy, nauseous, really fatigued. Today (11Jan2021), the fatigue is gone but still lightheaded and nauseous. I don't have a fever. At times, it feels like hot flashes and I take my temperature and I am fine. I feel lousy and don't feel well overall. As far as having COVID19, are these symptoms (per REQ#: lightheaded, dizzy, nauseous, really fatigued) and should I get tested?" The outcome of the event fatigued was recovered. The outcome of the events feels like hot flashes and feel lousy/don't feel well overall was unknown. The outcome of the other events was not recovered. Information about Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 0947586
Sex: F
Age:
State: CA

Vax Date: 12/20/2020
Onset Date: 12/25/2020
Rec V Date: 01/15/2021
Hospital:

Lab Data: Test Date: 20201230; Test Name: nasal swab PCR test; Test Result: Negative ; Test Date: 20210108; Test Name: nasal swab PCR test; Test Result: Negative

Allergies:

Symptoms: Daily Headaches; This is a spontaneous report from a non-contactable nurse (patient). A 31-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date: unknown), via an unspecified route of administration, on left arm, on 20Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included allergy to bacteria. The patient is not pregnant. Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE]), colecalciferol (VIT D3), choline, ascorbic acid, pyrroloquinoline quinone, tocopherol (PQQ), and lavandula angustifolia extract, melissa officinalis extract, origanum vulgare extract (MELATON [LAVANDULA ANGUSTIFOLIA EXTRACT;MELISSA OFFICINALIS EXTRACT;ORIGANUM VULGARE EXTRACT]). The patient had no prior Covid vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Dec2020, the patient experienced daily headaches but did not receive any treatment. The patient underwent lab tests and procedures which included nasal swab PCR test on 30Dec2020 and on 08Jan2021, both showed negative. Outcome of the event daily headaches was unknown.

Other Meds: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECA; VIT D3; ; PQQ; MELATON [LAVANDULA A

Current Illness:

ID: 0947587
Sex: F
Age:
State: PA

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Left arm pain from shoulder to elbow; extreme fatigue; headache; joint pain; chills; low grade fever; nausea; This is a spontaneous report from a contactable Other HCP reported for herself (patient). This 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284), via an unspecified route of administration from 07Jan2021 at 15:45 at single dose on left arm for COVID-19 immunisation. Medical history included COVID-19 and was sick for 17 days, no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified concomitant medications. The patient experienced left arm pain from shoulder to elbow, extreme fatigue, headache, joint pain, chills, low grade fever, nausea on 07Jan2021 at 21:00. Symptoms started five hours after injection and did not abate until about 64 hours after vaccination. No treatment was received for the events and all considered as non-serious. The outcome of the events was recovered in Jan2021.

Other Meds:

Current Illness:

ID: 0947589
Sex: F
Age:
State: NY

Vax Date: 12/21/2020
Onset Date: 01/09/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data: Test Date: 20210109; Test Name: Covid-19; Test Result: Positive

Allergies:

Symptoms: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiration date: 31Mar2021), via intramuscular on 21Dec2020 at 0.3 mL single in left deltoid for preventative. Medical history included she only had one kidney from 25Feb2020. There were no concomitant medications. It was reported that the patient was supposed (was scheduled) to get her second dose today (11Jan2021) but this past weekend she tested positive for COVID on 09Jan2021. The patient wanted to know if it would affect getting the second dose of the vaccine. The patient supposed to be quarantining right now and she was not symptomatic. On 09Jan2021 she found out she was positive for covid. The outcome of the event was unknown.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.

Other Meds:

Current Illness:

ID: 0947590
Sex: U
Age:
State: CA

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sick; fever; body aches; sinus; lymph nodes swelled; joint pain; headaches; This is a spontaneous report from a contactable nurse reported for self (patient). This 44-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: E51685), intramuscular on 21Dec2020 at 07:30 at single dose on left arm for COVID-19 immunisation. There was no medical history or allergies to medications, food, or other products. The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After first dose on 21Dec2020, the patient had sick, fever, body aches, sinus, lymph nodes swelled, joint pain, headaches. All of the events considered as non-serious and no treatment was received. The outcome of the 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. The patient received the second dose of BNT162B2 (lot: Ek9231) on 11Jan2021 on the left arm.

Other Meds:

Current Illness:

ID: 0947591
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: I got a headache in eye; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported similar events for two patients. This is the 2nd of of two reports. A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 got a headache in eye on an unspecified date the moment she had vaccine but it went away. Outcome of the event was recovered. The event was assessed as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021021969 same drug/similar events, different patients

Other Meds:

Current Illness:

ID: 0947592
Sex: F
Age:
State: NY

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Hives on neck, chest, and back; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm, on 07Jan2021 at 10:15, at a single dose, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications included ethinylestradiol/ ferrous fumarate/ norethisterone acetate (LO LOESTRIN FE), prednisone, azithromycin (Z-PAK), and guaifenesin (MUCINEX). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 07Jan2021 (10:45), the patient experienced hives on neck, chest, and back starting about 30 minutes after the vaccine was received. It is 11Jan2021 and the patient still have them. The event was considered non-serious. Treatment was received for the adverse event including diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.

Other Meds: LO LOESTRIN FE; ; Z-PAK; MUCINEX

Current Illness:

ID: 0947593
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: he is infected with COVID-19; he is infected with COVID-19; This is a spontaneous report from a contactable nurse (patient). A male patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 called to find out if there should be a delay in the second dose because he was infected with COVID-19 on an unspecified date. His second dose was scheduled on 13Jan2021 and he was wondering if he should continue in 2 days. 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 BNT162B2 in this patient cannot be completely excluded.

Other Meds:

Current Illness:

ID: 0947594
Sex: F
Age:
State:

Vax Date: 12/21/2020
Onset Date: 12/27/2020
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: she had a little bleed in the blood vessel of her left eye; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asking if bleeding of the eye was an adverse reaction to bnt162b2. Patient received the Covid vaccine on 21Dec2020 and on the 27Dec2020, she had a little bleed in the blood vessel of her left eye. She was supposed to get the second vaccine today (11Jan2021) at 12:30. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0947595
Sex: M
Age:
State:

Vax Date: 12/25/2020
Onset Date:
Rec V Date: 01/15/2021
Hospital:

Lab Data: Test Date: 20210111; Test Name: covid; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: got the first dose of the vaccine and on 25Dec2020, he started getting symptoms of possible covid; got the first dose of the vaccine and on 25Dec2020, he started getting symptoms of possible covid; This is a spontaneous report from a contactable pharmacist. A 7-decade-old (65 years or 66 years) male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The stated, "my uncle got the first dose of the vaccine and on 25Dec2020, he started getting symptoms of possible Covid. He got tested for covid today (11Jan2021). He's supposed to get the second dose on 15Jan2021. If he is positive for covid, what does that mean for his second dose? If he is positive, and waits for quarantine, then he wouldn't be able to get the second dose until day 36." The outcome of the events was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.

Other Meds:

Current Illness:

ID: 0947596
Sex: F
Age:
State: FL

Vax Date: 01/05/2021
Onset Date: 01/08/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data: Test Name: pressure; Result Unstructured Data: Test Result:elevated

Allergies:

Symptoms: numbness in her mouth and shoulder; numbness in her mouth and shoulder; blurry vision; elevated pressure; her arm became painful; sharp pain in the middle of the chest; This is a spontaneous report from a contactable consumer reported for self. This female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 15:30 pm at single dose for covid-19 immunisation. Medical history included rib surgery last Sep2020. She had an episode on Friday morning 08Jan2021 with a sharp pain in the middle of the chest that was so bad she had to take Ibuprofen and lie down with a heating pad to her chest. After that, she had numbness in her mouth and shoulder, and had blurry vision to which she had her son call 911. As the EMTs arrived they recorded her with elevated pressure and took a cardiogram which reported everything was 'perfect', no stroke, no heart attack. She mentioned that she had a rib surgery last Sep2020 and was still healing and took pressure medication for it, She mentioned that the EMTs told her to take the medication in the morning and not in the afternoon and that the episode was not related to the vaccine. She also reported that her arm became painful for a day after the injection but it did not cause her anything else. She knows that other ladies who received the vaccine in her building had flu-like symptoms and was asking if her symptoms were reported for the vaccine. Patient mentioned that she was calling to report her side effects and that she will receive the 2nd dose on 26Jan2021. Outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0947598
Sex: F
Age:
State: OK

Vax Date: 12/21/2020
Onset Date: 12/22/2020
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Arm was very sore; Muscle aches; Scratchy throat; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: 9899), via an unspecified route of administration in right arm, on 21Dec2020 at 19:00, at a single dose, for COVID-19 immunization. The patient's medical history included attention deficit disorder (ADD), gastroesophageal reflux disease (GERD), migraines, allergies to latex and cinnamon (severe), gluten intolerance, and lactose intolerant. The patient's concomitant medications included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), candesartan, galcanezumab GNLM (EMGALITY), glucosamine, magnesium, melatonin, iron, escitalopram oxalate (LEXAPRO), omeprazole, ursodiol, colecalciferol (VIT D3), and buspirone hydrochloride (BUSPAR). The patient previously took acetylsalicylic acid (ASPIRIN), fentanyl, and codeine and experienced allergies to the medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 22Dec2020 at 9 AM, the patient's arm was very sore and had some muscle aches and scratchy throat. These lasted a little over 48 hours (2 days). The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 24Dec2020.

Other Meds: ADDERALL; ; EMGALITY [GALCANEZUMAB GNLM]; ; ; ; ; LEXAPRO; ; URSODIOL; VIT D3; BUSPAR

Current Illness:

ID: 0947599
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: outbreak of shingles; This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient inquired if she can she be on an antiviral when receiving her second dose of the vaccine. She is aware that our trial participants with a history of HIV were on antivirals as well. The patient mentioned that she had an outbreak of shingles which occurred after she had her first COVID vaccination. She stated that she doesn't associate it with the COVID vaccine however. She was supposed to start treatment on Valtrex shortly has not started it yet. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: While reporter causality is noted, a possible contributory effect of suspect BNT162B2 on reported event cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0947600
Sex: M
Age:
State: HI

Vax Date: 01/07/2021
Onset Date: 01/01/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sore arm; This is a spontaneous report received from a contactable (patient). A male patient of an unspecified age (reported as "51", unit not provided, pending clarification) received BNT162B2 (BIONTECH COVID-19 VACCINE lot number and expiry date not provided), via an unspecified route of administration, on 07Jan2021, at single dose, for COVID-19 immunization. Medical history included ongoing glucose-6-phosphate dehydrogenase (G6PD) deficiency. The patient reported that he and his brother both have G6PD. The patient's concomitant medications were not reported. The patient received the vaccine last Thursday, 07Jan2021, and experienced sore arm on an unspecified date in Jan2021. The patient was wondering if he and his brother are eligible to receive the vaccine, or if there is any data on the vaccine and people with their condition. The outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness: G6PD deficiency (He and his brother both have G6PD.)

ID: 0947601
Sex: F
Age:
State: MN

Vax Date: 01/06/2021
Onset Date: 01/10/2021
Rec V Date: 01/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: congestion; headache; running nose; This is a spontaneous report from a contactable Nurse reporting for herself. A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1686) via an unspecified route of administration on left arm, on 06Jan2021, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were reported as none. On 10Jan2021, the patient experienced congestion, running nose and headache. The headache comes and goes. Outcome of the events congestion and headache was recovering at the time of the report while it was unknown for running nose.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm