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: 0924877
Sex: U
Age: 1
State: FL

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: A medical assistant reported VARlVAX was improperly stored and administered.; This spontaneous report was received from a medical assistant, referring to a 12-months-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided. On 04-JAN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T021824, which has been verified to be valid, expiration date reported and validated as 25-JUN-2022). The vaccine administered experienced a temperature excursion of 16.1 degrees Fahrenheit (product storage error), for a time frame of 1 hour and 45 minutes, as recorded by a data logger. There was no previous temperature excursion reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2101USA000920:Case number 01835185 US-009507513-2101USA000916:Case number 01835180

Other Meds:

Current Illness:

ID: 0924878
Sex: U
Age:
State: MD

Vax Date:
Onset Date: 12/17/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No other AE reported; temperature excursion; This spontaneous report has been received from an unspecified source referring to a patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided. On an unknown date, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1637648 and lot # S010729 (strength, indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. The vaccine was exposed to a temperature range between 32.9 F and 34 ?F, during a time frame of 16 hours which was called by a data logger (product storage error). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 0924879
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: had a severe reaction to PNEUMOVAX 23; This spontaneous report was received from a female patient of unknown age referring to herself. The patient's medical history, concurrent condition and concomitant medication were not provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis. On an unknown date, the patient had a severe reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) previously and was hospitalized. No additional adverse event details provided due to consumer being unable to be transferred to agent. The outcome of vaccination complication was unknown. The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was related.

Other Meds:

Current Illness:

ID: 0924880
Sex: F
Age: 50
State: NJ

Vax Date: 10/06/2020
Onset Date: 10/06/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data: Test Date: 20201007; Test Name: Biopsy; Result Unstructured Data: (Test Result:Pleva,Unit:unknown,Normal Low:,Normal High:); Test Date: 20201007; Test Name: Heart rate; Result Unstructured Data: (Test Result:Extra beats,Unit:beats/min,Normal Low:,Normal High:)

Allergies:

Symptoms: broke out / confirmed to be Pleva; Heart issues / has a heart monitor and reports extra beat; Drug dose administration interval too short; This case was reported by a consumer via call center representative and described the occurrence of pityriasis lichenoides in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had past medical history included shingles). Previously administered products included Shingrix with an associated reaction of parapsoriasis (1st dose received on 14th August 2020, refer case for 1st dose US2020199106). On 6th October 2020, the patient received the 2nd dose of Shingrix. On 6th October 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On 7th October 2020, the patient experienced pityriasis lichenoides and heart rate increased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pityriasis lichenoides, heart rate increased and drug dose administration interval too short were unknown. It was unknown if the reporter considered the pityriasis lichenoides and heart rate increased to be related to Shingrix. Additional details were provided as follows: The reporter stated that, the patient had break out after 2nd dose administration. The patient saw dermatologist and breakout was biopsied and confirmed to be Pleva. The patient reported extra beat happened at the same time as Pleva breakouts. The reporter did not confirmed if heart issue related to Shingrix. The reporter stated that, the patient received 2nd dose earlier than the recommended schedule (2-6 months) which led to shortening of vaccination schedule.; Sender's Comments: US-GLAXOSMITHKLINE-US2020199106:same reporter

Other Meds:

Current Illness:

ID: 0924881
Sex: M
Age: 62
State: NJ

Vax Date: 09/01/2020
Onset Date:
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Shivers; Nausea; This case was reported by a consumer via call center representative and described the occurrence of shivering in a male patient who received Herpes zoster (Shingrix) for prophylaxis. In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shivering and nausea. On 23rd November 2020, the outcome of the shivering and nausea were recovered/resolved. It was unknown if the reporter considered the shivering and nausea to be related to Shingrix. Additional details were provided as follows: The patient reported for himself. The patient experienced some shivers and nausea with the first dose but it resolved quickly. The patient followed up with disease control and prevention guidelines. The reporter did not consent to follow-up and declined to provide HCP information. For tolerance of 2nd dose of Shingrix, refer case US2020232824.; Sender's Comments: US-GLAXOSMITHKLINE-US2020232824:Same reporter. 2nd dose

Other Meds:

Current Illness:

ID: 0924882
Sex: U
Age:
State:

Vax Date: 11/20/2020
Onset Date: 11/24/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: veins in my feet are. bulging; there are whelps; This case was reported by a consumer via interactive digital media and described the occurrence of vein disorder in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included penicillin allergy (allergic to penicillin and all its derivatives). Concomitant products included rasagiline mesilate (Azilect). On 20th November 2020, the patient received Shingrix. On 24th November 2020, 4 days after receiving Shingrix, the patient experienced vein disorder and welts. On an unknown date, the outcome of the vein disorder and welts were not recovered/not resolved. It was unknown if the reporter considered the vein disorder and welts to be related to Shingrix. Additional details were provided as follows: The patient reported for himself/herself. The age group was not reported but was selected as adult as per vaccine indication. It was reported that on the night of 24th November 2020 the patient's veins in feet were bulging and there were whelps. The patient could not find what the ingredients were for the vaccine. The patient said some medicines react to Azilect.

Other Meds: AZILECT

Current Illness: Penicillin allergy (allergic to penicillin and all its derivatives)

ID: 0924883
Sex: F
Age:
State: WA

Vax Date: 09/18/2020
Onset Date:
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache; Discomfort / at injection site; Small swelling at injection site; Body aching (not severe); This case was reported by a nurse via call center representative and described the occurrence of headache in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 18th September 2020 09:00, the patient received the 1st dose of Shingrix. On 18th September 2020, less than a day after receiving Shingrix, the patient experienced headache, injection site discomfort, injection site swelling and general body pain. On an unknown date, the outcome of the headache, injection site discomfort and general body pain were recovered/resolved and the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the headache, injection site discomfort, injection site swelling and general body pain to be related to Shingrix. Additional details were provided as follows: The reporting retired nurse was the concerned patient. The age at vaccination was not reported but it could be 70 or 71 years. In the evening, the patient developed headache, discomfort and small swelling at injection site, and body aching (not severe). The patient reported not having fever neither chills. All symptoms were gone after 48 hours. No other information was provided. Lot number and Expiry date was not available at time of reporting. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 0924884
Sex: M
Age:
State:

Vax Date: 12/17/2020
Onset Date: 12/01/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data: Test Date: 20201228; Test Name: COVID; Test Result: Positive ; Comments: Tested positive for COVID

Allergies:

Symptoms: positive COVID test; positive COVID test; fever; chills; sore throat; cough; nasal congestion; runny nose; little diarrhea; tiny bit of shortness of breath; Caller received the COVID-19 vaccine on 17Dec2020 and is scheduled to take the second dose on 5Jan2021.; Caller received the COVID-19 vaccine on 17Dec2020 and is scheduled to take the second dose on 5Jan2021.; sore arm; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable physician (patient himself). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), via intramuscular route on 17Dec2020 at single dose (dose 1, left deltoid) for COVID-19 immunization. The patient medical history included non-smoker. Concomitant medications were reported as none. The patient was scheduled to take the second dose on 05Jan2021, also reported as 08Jan2021. The patient experienced sore arm for 24 hours afterwards on Dec2020. Patient experienced mild COVID symptoms such as fever, chills, sore throat, cough, nasal congestion, runny nose, little diarrhea, and tiny bit of shortness of breath on 24Dec2020, but stated he was better now. The patient was positive in the COVID test on 28Dec2020. He wanted to know if it was normal to get COVID after getting the vaccine and if he should get the booster shot if he gets better. He commented that testing positive for COVID was medically concerning. The patient did not require supplemental oxygen (including high flow ECMO) or receive a mechanical ventilation. Treatment included over the counter medication. No additional testing was done. The patient was not hospitalized. Outcome of the event sore arm was unknown; cough was not recovered; fever, chills, sore throat, nasal congestion, runny nose, little diarrhea, tiny bit of shortness of breath was recovering. No follow-up attempts are needed. Information about lot/batch number was already obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded. The case will be reassessed if additional information becomes available.

Other Meds:

Current Illness:

ID: 0924885
Sex: F
Age:
State: NV

Vax Date: 12/17/2020
Onset Date: 12/19/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 2days after my 1st Covid vaccine I broke out into a rash with hives requiring me to go to the ER; 2days after my 1st Covid vaccine I broke out into a rash with hives requiring me to go to the ER; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EH9899, expiry date was not provided) solution for injection, via an unspecified route of administration on left arm on 17Dec2020 08:00 at a single dose for Covid-19 immunization. Medical history included eczema, chronic kidney disease, thyroid disease. Patient had known allergies. The patient was not pregnant. Concomitant medications included apixaban (ELIQUIS), allopurinol (ALLOPURINOL), levothyroxine (LEVOTHYROXINE), iron (IRON), magnesium (MAGNESIUM). The patient reported that 2 days after her 1st Covid vaccine, she broke out into a rash with hives requiring her to go to the ER on 19Dec2020 12:00. She also visited a physician. She was treated with steroids, Atarax, and Epi shot. The events were reported as non-serious. Outcome of the events was not recovered. No follow-up activities are needed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of urticaria and rash due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics 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: ELIQUIS; ; ; ;

Current Illness:

ID: 0924886
Sex: U
Age:
State: NJ

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

Lab Data: Test Name: tested; Test Result: Positive ; Comments: tested positive within 2-4 days of the vaccine and this patient had a known exposure to a covid positive person

Allergies:

Symptoms: tested positive within 2-4 days of the vaccine; tested positive within 2-4 days of the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the first of 2 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 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 nurse had questions about patients that received the first dose of the COVID 19 vaccine. One patient tested positive within 2-4 days of the vaccine and this patient had a known exposure to a COVID positive person. The nurse wanted to know if this patient should receive the second dose. The outcome of the events was unknown. 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 events of SARS-CoV-2 test positive and LOE due to temporal relationship. 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.,Linked Report(s) : US-PFIZER INC-2020520414 Same reporter, drug, and events; different patients

Other Meds:

Current Illness:

ID: 0924887
Sex: F
Age:
State: AZ

Vax Date: 12/18/2020
Onset Date: 12/29/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data: Test Date: 20201229; Test Name: Covid test; Result Unstructured Data: Test Result:positive

Allergies:

Symptoms: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), 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 the first dose of the vaccine on 18Dec2020, and was tested positive for COVID yesterday, 29Dec2020. States that she knows she only has had the first dose and states her exposure level was high, states that she cannot believe she made it this far before testing positive. Second dose scheduled for 08Jan2021, wanting to know if she should get the second dose since she was now positive. The outcome of the events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded. The case will be reassessed if additional information becomes available.

Other Meds:

Current Illness:

ID: 0924888
Sex: F
Age:
State: CA

Vax Date: 12/20/2020
Onset Date: 12/27/2020
Rec V Date: 01/07/2021
Hospital:

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

Allergies:

Symptoms: positive Covid results with symptoms; positive Covid results with symptoms; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension (diagnosed 3-4 years ago), hyperlipemia (diagnosed 3-4 years ago), supraventricular tachycardia since 2017, and asthma; all ongoing. Family history included hypertension. She has no history of adverse reactions or allergies to any vaccines received previously. The patient's concomitant medications were not reported. The patient explains that she got the COVID-19 vaccine on 20Dec2020. Afterward she had some coughing, so she went for a rapid test and found she tested positive after the vaccine. The patient was wondering if this has been reported previously, where someone tested positive after getting the vaccine. She has never tested positive before. She got the results on 28Dec2020 that she was positive. She was now in a hotel quarantining. She was looking trying to find information on this occurring. Since she was in the hotel, she would prefer to use email as communication for follow-up. The patient noticed the cough on 25Dec2020. She works nights so she stayed home on the 26Dec2020. Then on 27Dec2020 she had the test done and on 28Dec2020 the results were given to her and she was positive. Her second dose was due on 10Jan2020 and it was before the 14 days of quarantine will be up. She was checking to see is there anywhere else she can get the second dose. The patient explains that she has been researching and she wanted to get it because she was with elderly family members. She wanted to know how she was tested positive, what test was used as she had the rapid test. There were no treatments for the events. The caller patient was also experiencing a cough, sore throat, and nasal congestion. There was no shortness or anything else going on at this point. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded. The case will be reassessed if additional information becomes available.

Other Meds:

Current Illness: Asthma; Hyperlipemia (diagnosed 3-4 years ago); Hypertension (diagnosed 3-4 years ago); Supraventricular tachycardia

ID: 0924889
Sex: U
Age:
State:

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

Lab Data: Test Name: Covid; Result Unstructured Data: Test Result:positive

Allergies:

Symptoms: positive person for Covid after receiving the Covid vaccine; positive person for Covid after receiving the Covid vaccine; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer-BioNTech COVID-19 Vaccine, lot/batch number and expiry date were unknown), via an unspecified route of administration on unknown date at single dose, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was a positive person for Covid after receiving the Covid vaccine on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.

Other Meds:

Current Illness:

ID: 0924890
Sex: F
Age:
State: CA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Also had dizziness while sitting down. Felt like I would have fallen if I stood up so I sat for 20mins.; Mental confusion; couldn't gather my thoughts or write what I wanted to say; mental 'fog'; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 34-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm, on 28Dec2020 13:15 at single dose for COVID-19 immunization. Medical history allergy to penicillin. The patient is not pregnant during the time of vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and cefalexin (KEFLEX) and experienced allergies to both. The patient experienced mental confusion, mental 'fog', "couldn't gather my thoughts or write what I wanted to say", also had dizziness while sitting down (felt like I would have fallen if I stood up so I sat for 20mins) all on 28Dec2020 at 13:15. The patient did not receive treatment for the events. 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 28Dec2020 at 13:45 (reported as events subsided after 30 minutes). The reporter assessed the case as non-serious.

Other Meds:

Current Illness:

ID: 0924891
Sex: F
Age:
State: GU

Vax Date: 12/29/2020
Onset Date: 12/01/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data: Test Date: 202012; Test Name: blood pressure; Result Unstructured Data: Test Result:180/80; Comments: 7:35 am; Test Date: 202012; Test Name: blood pressure; Result Unstructured Data: Test Result:146/62; Comments: 9:37 am; Test Date: 202012; Test Name: pulse; Result Unstructured Data: Test Result:62

Allergies:

Symptoms: Her measured blood pressure at 7:35 am was 180/80 but came down to 146/62 at 9:37 am; arms had some pain; chills; headache; a stiff neck pain at the back of her neck; a stiff neck pain at the back of her neck; a trembling pain; This is a spontaneous report from a contactable consumer. This is the 1st of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated on Dec2020, "she reported that she herself felt fine but her arms had some pain. She was having chills, a headache, a stiff neck pain at the back of her neck, and a trembling pain. Her measured blood pressure at 7:35 am was 180/80 but came down to 146/62 at 9:37 am. Her pulse was at 62 bpm, Caller is asking for recommendations". The outcome of "her measured blood pressure at 7:35 am was 180/80 but came down to 146/62 at 9:37 am" was recovering and other events was unknown. Information about Lot/batch no has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520380 same reporter/drug, different patient/event

Other Meds:

Current Illness:

ID: 0924892
Sex: M
Age:
State: FL

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

Lab Data:

Allergies:

Symptoms: extremely lightheaded; like he was about to fall down; This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is the 1st of 2 reports. An 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL0140), intramuscular on the right arm on 30Dec2020 10:10 at single dose for vaccination. Medical history included covid-19 on Jul2020 and had it fairly severe and almost died and he mentions he was overweight. There were no concomitant medications. The patient previously took flu shot (INFLUENZA VACCINE), a couple of months ago. He mentions he was in the military so he had a lots of shots in his life but he has never had a reaction like this. The patient stated that on 30Dec2020 10:30, "he became extremely lightheaded, like he was about to fall down. He sat down and is currently sitting down. This lightheadedness started about 20 minutes after the injection. When probed for the outcome, the caller explains it might be improving a little. The lightheadedness is not still not gone, but it has not worsened. When probed for seriousness criteria, the caller explains he is just resting and sitting. He would say its not serious but it could be medically significant. He states he isn't sure if this is something that happens to just people who have had COVID before. He states none of his friends or relatives have this type of reaction. He lives in a retirement home and everybody is getting the injection. This is the second day of injections. He doesn't know if anybody had a reaction to the COVID-19 vaccine here". The outcome of the events were recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of lightheadedness and pre-syncope due to temporal relationship. 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.,Linked Report(s) : US-PFIZER INC-2020520862 same reporter/drug, similar event, different patient.

Other Meds:

Current Illness:

ID: 0924893
Sex: F
Age:
State: PA

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:165/124; Comments: Her Blood pressure was high/ She doesn't know if it was accurate, but it was 165/124 at one point; Test Name: blood pressure; Result Unstructured Data: Test Result:usually around 110/70; Test Name: blood pressure; Result Unstructured Data: Test Result:always very low usually; Test Name: pulse rate; Result Unstructured Data: Test Result:accurate; Comments: She did not provide her pulse rate.

Allergies:

Symptoms: Vomiting/threw up; Headache; muscles got rigid and tight in her neck; muscles got rigid and tight in her neck; sick; She doesn't know if she had the flu bug or not; She also had very high blood pressure. It was through the roof/Blood pressure was high and she was concerned she would have a stroke; Muscle soreness; Arm soreness; This is a spontaneous report from a contactable healthcare professional (physical therapist). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 21Dec2020 08:15 at a single dose for COVID-19 immunisation; and sumatriptan from 25Dec2020 to an unspecified date at unknown dose and frequency (standard unknown dose/ She only gets 9 pills a month) for migraine. Medical history included ongoing migraine, obesity (She would say she was kind of obese), coeliac disease (She had Celiac disease and cannot eat gluten which was diagnosed since she was 4), chronic back pain (this was diagnosed a couple of years before she took the COVID vaccine), spinal stenosis (this was diagnosed a couple of years before she took the COVID vaccine), and pain (she took hydrocodone for pain but did not take any that day). Concomitant medication included hydrocodone for pain. Prior Vaccinations (within 4 weeks) and events following prior vaccinations were none. The patient had the vaccine on 21Dec2020, and she got sick on Christmas day. She was vomiting at 14:00 and did not know if it was a side effect or not. She did have arm soreness muscle soreness at 15:00, that evening and the next day too. She normally gets a migraine once a month. She does not normally throw up with a headache though. The vomiting started when she threw up twice on 25Dec2020, then once on morning of 26Dec2020. She also had very high blood pressure. It was through the roof. She did not know if that was related to drug for migraine or vaccine. She also had the headache at 14:00 the whole time. She believed she threw up before she took Sumatriptan. The muscles got rigid and tight in her neck and she doesn't think she took it. She threw up and then she took it. She did not have a lot or expiration. There was no ER nor physician's office required. She would have it if her car was not buried in snow. Her blood pressure was high and she was concerned she would have a stroke. It was usually around 110/70 and was always very low usually. She did not know if it was accurate, but it was 165/124 at one point and she did know her pulse was accurate. She did not provide her pulse rate. She did not know if she was throwing up because her blood pressure was high and did not know if blood pressure was high because of Sumatriptan. She only gets 9 pills a month. She did not know if high blood pressure was one of the side effects. It was not a real safe medication to take once a day. She only took it once a month and only once that day. She had never thrown up with migraines before and was just concerned. She doesn't usually take her blood pressure and doesn't know if the Sumatriptan always makes it go up or not. She doesn't know if she had the flu bug or not. The action taken in response to the events for bnt162b2 was not applicable, while for sumatriptan was unknown. Clinical outcome of sickness and influenza was unknown, for headache was recovered on 27Dec2020, while for the other events was recovering. Information on the lot/batch 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 elevated BP and other reported events due to temporal relationship. 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: Migraine

ID: 0924894
Sex: F
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: allergic reaction; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK 5730, expiry date unknown) via unspecified route of administration at left arm on 30Dec2020 08:30 at single dose for Covid-19 immunization in a hospital facility. The patient was not diagnosed with Covid-19 prior vaccination. Medical history was none. Concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 at 08:45, the patient experienced allergic reaction which resulted to patient visiting doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. The patient received treatment of epinephrine, decadron and Benadryl due to the event. The patient was not Covid tested post vaccination. The outcome of the event allergic reaction was recovering at this time of the report. The reporter considered the event non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Allergic reaction cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0924895
Sex: F
Age:
State: PA

Vax Date: 12/22/2020
Onset Date: 12/27/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: peripheral neuropathy type symptoms; tingling of the feet, legs, hands, arms; This is a spontaneous report from a contactable Other Health Professional (patient). A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at Left arm on 22Dec2020 10:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypothyroidism. The patient had no known allergies. Concomitant medication included levothyroxine and multivitamin. No other vaccine in four weeks. The patient was not sure if this was related to the vaccine or not. The patient didn't know if anyone else was having peripheral neuropathy type symptoms such as tingling of the feet, legs, hands, arms. The symptoms started a few days ago. The patient did not even sure if it related to the vaccine. Adverse event start date was 27Dec2020. Covid was not tested post vaccination. The outcome of the events was not recovered. No treatment received for the events. Information on the lot/batch number has been requested.; Sender's Comments: The temporal relationship between the onset of the event and administration of the vaccine does not support a causal 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: 0924896
Sex: F
Age:
State: PA

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Mild- moderate tenderness in left deltoid; This is a spontaneous report from a contactable physician. A 61-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number=EK 9231, via an unspecified route of administration, in left arm, on 30Dec2020 at 13:45 (at the age of 61 years-old for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included allergic rhinitis, a distant history of thyroid cancer and an allergy to iodine. Concomitant medication included biotin (BIOTIN), cetirizine (CETIRIZINE), fish oil (FISH OIL), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), levothyroxine sodium (SYNTHROID). . The patient has not had any vaccinations in 4 weeks. The patient has taken other medications (concomitant medications) within 2 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 31Dec2020 at 0700 the patient experienced mild- moderate tenderness in left deltoid. The patient was not hospitalized for the event nor received any treatment. The clinical outcome of the mild- moderate tenderness in left deltoid was recovering. Since the vaccination, the patient had not been tested for COVID-19.

Other Meds: ; ; ; FLONASE [FLUTICASONE PROPIONATE]; SYNTHROID

Current Illness:

ID: 0924897
Sex: F
Age:
State: TX

Vax Date: 12/28/2020
Onset Date: 12/30/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: feels pretty sick; Nauseous; going to the bathroom a lot; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported for a female patient of an unspecified age received BNT162b2, via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. Medical history included tooth extraction and bone graft, and was not feeling real well after that. The patient's concomitant medications were not reported. Patient received COVID vaccine on 28Dec2020. Patient stated she feels pretty sick since getting the COVID-19 Vaccine, saying she is mainly nauseous and going to the bathroom a lot; all from 30Dec2020. The patient said she went to the dentist, and got an antibiotic. She was prescribed Amoxicillin 500mg, three times a day, by her dentist. She said she took her first dose of Amoxicillin 500mg this morning (31Dec2020). She said after she took the first Amoxicillin 500mg dose, she thought she better check to see if it is OK to take an antibiotic after receiving the COVID-19 Vaccine. She did not necessarily think the nausea and going to the bathroom a lot had to do with receiving the COVID-19 Vaccine. She wanted to know if she takes an antibiotic after receiving the COVID-19 Vaccine, will the antibiotic cause a problem with the COVID-19 Vaccine. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product events most likely due to patient underlying contributory factors

Other Meds:

Current Illness:

ID: 0924898
Sex: F
Age:
State: IN

Vax Date: 12/20/2020
Onset Date: 12/26/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data: Test Date: 20201228; Test Name: fever; Result Unstructured Data: Test Result:102.6; Test Date: 20201228; Test Name: Covid/ PCR; Result Unstructured Data: Test Result:just detected

Allergies:

Symptoms: tested positive for covid; tested positive for covid; fever; headache; runny nose; nasal congestion; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first single dose of BNT162B2 (Solution for injection, lot number: EK5730, exp date: Mar2021), intramuscular (injected in left upper arm ) on 20Dec2020 12:30 to 20Dec2020 12:30 at 0.3 mL for immunisation. The vaccine was administered in a hospital and not in a military facility. Medical history included birth control. The patient had no other history. NO ER or physician's office required Prior Vaccinations (within 4 weeks). Patient had no relevant family history. Concomitant medication include unspecified birth control.There was no previous immunization. Patient, who was a Respiratory therapist, got the covid vaccine on 20Dec2020 (Sunday). She first stated she doesn't have any side effects and just had a question. Patient had COVID Symptoms on 26Dec2020 21:00 which was minimal like a runny nose. She further reports that on 26Dec2020 she started to have nasal congestion. On 27Dec2020 the nasal congestion worsened, and she started having a headache. She then experienced a 102.6 fever on 28Dec2020 (Monday). She has since tested positive for Covid on 28Dec2020 11:30. Patient asked if it was ok that she received the 2nd dose after testing positive for covid. Investigation assessment was not performed. There was no prescriber. She received at work because she was a front line healthcare worker. The patient does not have SARS-CoV2 antibodies at diagnosis but never tested for antibodies. The patient was not in the hospital, nor was admitted in ICU. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. No Multiorgan failure. The patient did not receive any additional therapies for COVID-19. The patient did not require the initiation of new medication or other treatment or procedure. PCR on 28Dec2020 (Saturday) Results: just detected. No units available. No reference ranges provided. Standard range was not detected. It was just detected or not detected ranges. No other test or diagnostic imaging performed. The patient had not been treated with immune modulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. No pre-existing diseases worsened during the SARS-CoV2 infection. The patient was recovering from event positive for covid and runny nose; nasal congestion was not recovered and outcome of the other events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given.

Other Meds:

Current Illness:

ID: 0924899
Sex: F
Age:
State: PA

Vax Date: 12/19/2020
Onset Date: 12/01/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: had side effects of "tongue feels swollen and globus sensation in my throat."; had side effects of "tongue feels swollen and globus sensation in my throat."; she did not have a lot of injection site pain, it very minimal.; bruise or ecchymosis at the injection site; bruise or ecchymosis at the injection site; This is a spontaneous report from a contactable physician (patient) via a Pfizer sponsored program Pfizer First Connect. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899) via intramuscular on 19Dec2020 09:00 on left deltoid at a single dose for COVID-19 prophylaxis. The patient medical history, family history and relevant tests were reported as none. Current concomitant medications included multivitamin took 2 chewable gummies sporadically for years as supplementation therapy. The patient previously took Flu shots she got a sore arm. It was not bad. Tetanus gives her a sore arm, but that was all. Caller wanted to know what she should do for preparation to safely get second dose of Covid vaccine and how to fix what she was feeling right now, making sure it doesn't get worse, considering she is still having symptoms. Caller stated that she had side effects of tongue felt swollen and globus sensation in her throat. The transferring agent stated that he has a caller on the line that was calling about the Covid-19 Vaccine and reported that the patient got the shot on the 19Dec2020 and was inquiring about to proceed with her weird side effects. Caller had not told her physician about her symptoms yet. Caller clarified that she said a half an hour after the dose on 19Dec2020 09:30 she said that she had a Globus sensation or like a lump in her throat. Caller also reported that the back of her tongue felt swollen. Caller said that the Globus sensation was intermittent and it was not as prominent now as it was. Caller said that it was medically significant, but she has not sought medical treatment yet. Caller said that she still had a bruise or ecchymosis at the injection site. She said that the injection was high but reported that she did not have a lot of injection site pain, it very minimal. No emergency room or physician office required. The outcome of the event tongue felt swollen and globus sensation in her throat was recovering and the outcome of the event a bruise or ecchymosis at the injection site was not recovered and the outcome of the event minimal injection site pain was unknown.; Sender's Comments: There is a plausible chronological association between vaccine administration and onset of the events. Causality cannot be completely excluded.

Other Meds:

Current Illness:

ID: 0924900
Sex: F
Age:
State: PA

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: had a reaction of bells palsy with mild symptoms 5 minutes of receiving covid vaccine; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; This is a spontaneous report from a contactable Other Health Professional reported that a 35-year-old female patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications was not reported. The patient experienced a reaction of bells palsy with mild symptoms 5 minutes of receiving Covid vaccine. "facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better, patient was vaccinated 10 days ago on 21Dec2020. Patient was treated with 60mg of Prednisone for 5 days which was started today." Question is regarding the 2nd dose of Covid vaccine, whether or not she should have it. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. .; Sender's Comments: There is a positive chronological association between vaccine administration and onset of the events. Causality 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: 0924901
Sex: F
Age:
State: WA

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

Lab Data:

Allergies:

Symptoms: felt flushed; itch and felt tightness in her throat; itch and felt tightness in her throat; fatigue; arms and legs feel heavy; This is a spontaneous report from a contactable nurse (patient herself). A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: Ek5730, expiration date: unknown), via an unspecified route of administration on the left arm on 30Dec2020 at 08:00 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included Hashimotos, Celiac, nonalcoholic fatty liver, and known allergies to gluten, eggs whites and eggs yolks, mustard seed, and penicillin. Concomitant medications included cetirizine hydrochloride (ZYRTEC), thyroid (NATURE THROID), and an unspecified women's multivitamin. The patient was not pregnant at the time of vaccination. 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 had not been tested for COVID-19. On 30Dec2020 at 08:15, also reported as within 10 minutes, the patient felt flushed and at 20 minutes, she started to itch and felt tightness in her throat. The patient left after 30 minutes to go home and take diphenhydramine (BENADRYL). The patient worked at night and slept most of the day except to take BENADRYL and call out from work. Also on 30Dec2020, she noticed fatigue when she woke in the afternoon and her arms and legs felt heavy. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of itch and felt tightness in her throat. She had been on BENADRYL 50 mg every 4-6 hours. The itching and throat tightness remained unchanged. She had used an albuterol inhaler 3 times. The patient did not receive treatment for the other events. The patient was not recovered from the events "felt flushed, itch and felt tightness in her throat, fatigue, and arms and legs feel heavy."

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; NATURE THROID

Current Illness:

ID: 0924902
Sex: F
Age:
State: TX

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

Lab Data: Test Name: cov-19 test; Test Result: Positive

Allergies:

Symptoms: now have a positive cov-19 test results; now have a positive cov-19 test results; This is a spontaneous report from a contactable nurse reporting for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, on an unspecified date, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient took first round of cov-19 shot and due to take 2nd one Saturday but now have a positive cov-19 test result. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given.

Other Meds:

Current Illness:

ID: 0924903
Sex: F
Age:
State: PA

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Swollen and numb upper lip; Swollen and numb upper lip; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), via an unspecified route of administration in the left arm on 31Dec2020 at 12:30 PM (at the age of 40-year-old) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus, high cholesterol, and hypothyroidism. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included atorvastatin (LIPITOR), metformin, sitagliptin (JANUVIA), empagliflozin (JARDIANCE), and dulaglutide (TRULICITY). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 07:00 AM, the patient experienced swollen and numb upper lip. The events were reported as non-serious. The patient did not receive any treatment for the swollen and numb upper lip. The clinical outcome of the swollen and numb upper lip was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds: LIPITOR [ATORVASTATIN]; ; JANUVIA [SITAGLIPTIN]; JARDIANCE; TRULICITY

Current Illness:

ID: 0924904
Sex: F
Age:
State: IN

Vax Date: 12/22/2020
Onset Date: 12/29/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Painful, swollen lymph node in left axilla, same side as injection site; Painful, swollen lymph node in left axilla, same side as injection site; This is a spontaneous report from a contactable healthcare professional (the patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number Ek5730), intramuscularly in the left arm on 22Dec2020 at 16:00 (at the age of 32-years-old) as a single dose for COVID-19 immunization. There was no medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included tramadol, cyclobenzaprine hydrochloride (FLEXERIL), ibuprofen (ADVIL), paracetamol (TYLENOL), all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020, the patient experienced painful, swollen lymph node in left axilla, same side as injection site. No treatment was given for these events. The clinical outcome of painful, swollen lymph node in left axilla, same side as injection site was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds: ; FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]; ADVIL; TYLENOL

Current Illness:

ID: 0924905
Sex: F
Age:
State: WA

Vax Date: 12/17/2020
Onset Date: 12/23/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: swollen lymph node in her left axilla/lymphadenopathy; pain in her left axilla; able to palpate a swollen lymph node in her left axilla; This is a spontaneous report from a contactable physician (the patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1685), intramuscularly in the left arm on 17Dec2020 at 11:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. There was no medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included famotidine and fexofenadine hydrochloride (ALLEGRA), both for unknown indications from unknown dates and unknown if ongoing. The patient previously took and had an allergy to amoxicillin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 23Dec2020 at 13:00, the patient developed pain in her left axilla (6 days after vaccination). The patient was able to palpate a swollen lymph node in her left axilla. It continued to become more painful requiring ibuprofen and hot compresses. By 31Dec2020, her symptoms had largely resolved. She saw her physician who also felt the lymphadenopathy and had no other explanation than possible vaccine side effect. The clinical outcome of pain in her left axilla, swollen lymph node in her left axilla/lymphadenopathy, able to palpate a swollen lymph node in her left axilla was recovered on 31Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds: ALLEGRA;

Current Illness:

ID: 0924906
Sex: F
Age:
State: NY

Vax Date: 12/17/2020
Onset Date: 12/27/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data: Test Date: 20201231; Test Name: Nasal Swab; Test Result: Positive

Allergies:

Symptoms: Contracted covid 19 virus after receiving first dose of vaccine; Contracted covid 19 virus after receiving first dose of vaccine; This is a spontaneous report from a contactable nurse. A 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Eh9899), intramuscular in left arm on 17Dec2020 18:00 at a single dose for covid-19 vaccination. Vaccine was administered in the hospital. There were no relevant medical history. The patient had no known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID). On 27Dec2020 20:00, the patient contracted covid 19 virus after receiving first dose of vaccine. The outcome of the event was recovering. The patient did not received any treatment. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient did not have COVID prior to vaccination. The patient was tested for COVID post vaccination. The patient had nasal swab on 31Dec2020 and had a positive result.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given.

Other Meds: SYNTHROID

Current Illness:

ID: 0924907
Sex: M
Age:
State: MI

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data: Test Date: 20210101; Test Name: Body temperature; Result Unstructured Data: Test Result:37.8; Comments: Fever 37.8

Allergies:

Symptoms: Fever 37.8 chills injection site pain; Fever 37.8 chills injection site pain; Fever 37.8 chills injection site pain; This is a spontaneous report from a contactable nurse, the patient. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection in the left arm on 31Dec2020 at 08:15 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. Medical history included Type2 DM (diabetes mellitus), hypertension, obesity, gout and Covid-19. Concomitant medications included unspecified medication(s). The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was previously diagnosed with COVID-19. On 01Jan2021 at 14:00, the patient experienced fever 37.8, chills and injection site pain. Treatment was provided for the events fever, chills and injection site pain included acetaminophen (TYLENOL 650mg). The outcome of the events fever, chills and injection site pain was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 0924908
Sex: F
Age:
State:

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

Lab Data: Test Name: tested; Test Result: Positive ; Comments: following the first dose of vaccine

Allergies:

Symptoms: tested positive following the first dose of vaccine; tested positive following the first dose of vaccine; This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she has a patient who tested positive following the first dose of vaccine and inquiring as to second dose recommendations. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: There is scant information at this point. Case will be reevaluated based on additional information during the follow-up

Other Meds:

Current Illness:

ID: 0924909
Sex: F
Age:
State: FL

Vax Date: 12/18/2020
Onset Date: 12/21/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: heart palpitations starting 3 days after receiving vaccine; This is a spontaneous report from a contactable Nurse reporting for self. A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 18Dec2020 08:45 as a single dose (Dose 1), right arm (age at vaccination 42-years old) for COVID-19 immunization. The patient is not pregnant and did not receive any other vaccine in the 4 weeks prior to the COVID-19 vaccine. Medical history included diabetes mellitus, drug hypersensitivity, and allergies sulfa. the patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (PRILOSEC), aripiprazole (ABILIFY), zolpidem tartrate (AMBIEN), famciclovir (FAMVIR), semaglutide (OZEMPIC), and cetirizine hydrochloride (ZYRTEC). On 21Dec2020 at 16:00, the patient experienced heart palpitations starting 3 days after receiving vaccine. The event was reported as non-serious. No treatment was received for the event. The palpitations were resolving. The patient wasn't COVID tested post-vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: PRILOSEC [OMEPRAZOLE]; ABILIFY; AMBIEN; FAMVIR [FAMCICLOVIR]; OZEMPIC; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 0924910
Sex: F
Age:
State: TX

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Dizziness; Nausea; This is a spontaneous report from a contactable other hcp, the patient. This 33-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly in the right arm on 28Dec2020 at 07:45 (at the age of 33-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was reported as none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication was reported as none and no other medications were received within 2 weeks of the vaccination. On 28Dec2020 at 08:00, the patient experienced dizziness and nausea. No therapeutic measures were taken as a result of the events. The events resulted in the patient requiring a doctor/clinic visit. The clinical outcome of dizziness and nausea was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0924911
Sex: F
Age:
State: CA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Sleep affected- awake 22 hours; Hyperactive anxiety reaction; This is a spontaneous report from a contactable nurse reporting for herself. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EJ1685 /expiration date: not provided), via an unspecified route of administration in the left arm, on 28Dec2020 at 07:45 AM (at the age of 45 years old) as a single dose for COVID-19 vaccination. Relevant medical history included penicillin allergy. The patient did not have any chronic diseases or illnesses. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 at 10:00 AM, the patient experienced hyperactive anxiety reaction- restless, impulsive and hyperactive. The patient could not sit still or control fidgeting and her sleep was affected, as she was awake 22 hours. The patient did not receive treatment for the events. The outcome of the events hyperactive anxiety reaction- restless, impulsive and hyperactive and sleep was affected was recovered on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 0924912
Sex: M
Age:
State: MN

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: joint pains; muscle aches; malaise; chills; fatigue; very mild headache; This is a spontaneous report from a contactable physician reporting on himself. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL0140/expiration date: not provided), via an unspecified route of administration, on 30Dec2020 at 05:00 PM (at the age of 68 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history included hypertension, gout, dyslipidemia, and dysthymia. The patient did not have any known allergies to any medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within two weeks were taken but were not provided. The patient did not receive any other vaccines on the same date or within 4 weeks prior to the COVID vaccine. On 31Dec2020, at 08:30 PM, the patient experienced joint pains, muscle aches, malaise, chills, fatigue, and very mild headache. The patient did not receive and treatment for these events. The outcome of the events joint pains, muscle aches, malaise, chills, fatigue, and very mild headache was recovering. Since the vaccination, the patient had not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 0924913
Sex: M
Age:
State:

Vax Date: 12/19/2020
Onset Date: 12/30/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data: Test Date: 20201226; Test Name: covid; Test Result: Negative ; Test Date: 20201230; Test Name: covid; Test Result: Positive

Allergies:

Symptoms: sore arm; aches and pains for a couple of days; a little headache; I received results yesterday and I am positive; I received results yesterday and I am positive; This is a spontaneous report from a non-contactable physician (patient). A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date was unknown, via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first covid vaccine dose on 19Dec2020, and due to get his second dose on 09Jan2021. The problem is he tested for the covid virus on Wednesday 26Dec2020 (was negative). He was tested again on the 30Dec2020, because his wife and son had tested positive on the 26Dec2020, he received the results yesterday and he is positive. He asked if he should proceed with the 2nd dose, another test on the 30th and tested positive. He reports that, other than initial side effects from the vaccine administration, sore arm, aches and pains for a couple of days, never had fever, a little headache for a day or two, he feels fine. The outcome of the events "a little headache" was recovered on an unspecified date while outcome of the other events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given.

Other Meds:

Current Illness:

ID: 0924914
Sex: F
Age:
State: TN

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Injection site pain; headache for 2 days; neck and lower back joint pain; neck and lower back joint pain; fever of 101; nausea; chills; neck and lower back joint pain; lethargy; This is a spontaneous report from a contactable Nurse (the patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899, expiration date unknown), intramuscularly, on 31Dec2020 at 07:30 (at the age of 30-years-old) an unspecified dose in the left arm for COVID-19 vaccination. Medical history included anxiety and depression from unknown dates. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 01:00 the patient experienced vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101 degrees, nausea, chills and lethargy. The patient did not receive any treatment for the events. The clinical outcomes of vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101degrees, nausea, chills and lethargy were reported as recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 0924915
Sex: F
Age:
State: AK

Vax Date:
Onset Date: 12/18/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Dry mouth and throat; Dry mouth and throat; This is a spontaneous report from a non-contactable consumer, the patient. An adult female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number Gl5730), via an unspecified route of administration in the left arm on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medication was none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Dec2020 the patient experienced dry mouth and throat. The events were reported as non-serious. The patient did not receive any treatment for the dry mouth and throat. The clinical outcome of dry mouth and throat was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 0924916
Sex: F
Age:
State:

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

Lab Data: Test Date: 202008; Test Name: Covid 19; Test Result: Positive ; Comments: Covid 19 positive in Aug2020

Allergies:

Symptoms: swelling; tenderness; a red lump at the injection site; a red lump at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient was Covid 19 positive in Aug2020. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced swelling, tenderness, and a red lump at the injection site. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0924917
Sex: M
Age:
State:

Vax Date: 12/15/2020
Onset Date: 12/25/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data: Test Date: 20201225; Test Name: COVID; Result Unstructured Data: Test Result:tested positive with COVID

Allergies:

Symptoms: tested positive with COVID; tested positive with COVID; This is a spontaneous report from a contactable nurse. A male patient (Age:22 Units: unspecified) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 15Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the 1st dose last 15Dec2020 and tested positive with COVID on 25Dec2020. The outcome of the event was unknown. He will have the COVID result 04Jan2021 to check if he was still positive. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information

Other Meds:

Current Illness:

ID: 0924918
Sex: F
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: Sore arm and fatigue after 30 minutes; Sore arm and fatigue after 30 minutes; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231), via an unspecified route of administration in the left arm 02Jan2021 at 12:00 PM (at the age of 48-year-old) as a single dose for COVID-19 immunization. Medical history included asthma, gastritis, and hypothyroidism. The patient had allergy to Sulfa. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine, formoterol fumarate, mometasone furoate (DULERA), salbutamol (ALBUTEROL HFA), omeprazole (PROTONIX), and alprazolam (XANAX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jan2021, at 12:30 PM, the patient experienced sore arm and fatigue after 30 minutes. The events were reported as non-serious. The patient did not receive any treatment for the sore arm and fatigue after 30 minutes. The clinical outcome of the events sore arm and fatigue after 30 minutes was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds: ; DULERA; ALBUTEROL HFA; PROTONIX [OMEPRAZOLE]; XANAX

Current Illness:

ID: 0924919
Sex: F
Age:
State:

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fever; Chills; Itchy neck outside; Itchy throat; Stiff shoulder; Pin and needles; joint pain in shoulder and arms; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 25-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EL1284, expiration date: unknown), intramuscularly on the right arm on 31Dec2020 at 15:30 at a single dose for COVID-19 immunization administered at the hospital. The patient's medical history and concomitant medications were not reported. The patient had no known allergies; no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. 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 had not been tested for COVID-19. On 31Dec2020 at 19:00, the patient experienced fever, chills, itchy neck outside, itchy throat, stiff shoulder, pin and needles, and joint pain in shoulder and arms. The reporter assessed the events as non-serious. The patient did not receive any treatment for the events. The patient was recovering from all the events.

Other Meds:

Current Illness:

ID: 0924920
Sex: F
Age:
State:

Vax Date: 01/03/2021
Onset Date: 01/03/2021
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: headache; This is a spontaneous report from a contactable consumer, the patient. This 38-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 03Jan2021 (at the age of 38-years-old) as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medication were not reported. On 03Jan2021 (reported as early today), the patient reported she feels fine, but has a little bit of a headache. She did not know if her headache was due to the vaccine or other reasons. The patient wanted to know if she could take ibuprofen. The clinical outcome of the headache was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0924921
Sex: F
Age:
State:

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: could not taste or smell; could not taste or smell; nasal congestion; Achyall over; Vomited; Migraine; lungs started burning; persistent dry cough; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 21Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced achy all over, vomited, migraine, lungs started burning, and persistent dry cough on 21Dec2020 and could not taste or smell and nasal congestion on 22Dec2020 at 15:00. The clinical course was reported as: The patient felt a little achy, then vomited. She had a migraine for 2 hours, lungs started burning, and had a persistent dry cough. The patient was achy all over. At about 3:00 PM the next day, the patient could not taste or smell and had nasal congestion. The patient stated that this could be typical for positive COVID-19 infection. The patient was later getting better and feeling better. The clinical outcome of achy all over, vomited, lungs started burning, persistent dry cough, could not taste or smell, and nasal congestion was recovering and of migraine was recovered in Dec2020. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.

Other Meds:

Current Illness:

ID: 0924922
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: developing a left facial droop; Bell's palsy; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable physician reported that a female patient of an unspecified age received the first dose of bnt162b2 (COVID-19 Vaccine) via an unspecified route of administration on an unspecified date in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician reported that the patient received the COVID-19 vaccine roughly two weeks ago (Dec2020) and is developing a left facial droop, they are concerned if that is a sign of facial Bell's palsy. It's left side and it's a facial droop. The physician was concerned if patient is developing Bell's palsy and they are wondering if she should get the second dose or not. The physician further stated that her patient got the vaccine like about 2 weeks ago and developed Bell's palsy three days after the administration of the vaccine (Dec2020) and of course she won't be able to get to see because we are all booked up until yesterday and that is like about a week ago, after the onset of Bell's palsy. Outcome of the event was unknown. Information about lot and batch has been requested.; Sender's Comments: The event is considered possibly related to the suspect product based on the assumed positive temporal association. The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular the following relevant information is not available: patient's medical history and concomitant medications, exact vaccination date, event outcome. 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: 0924923
Sex: F
Age:
State: FL

Vax Date: 12/23/2020
Onset Date: 12/01/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data: Test Date: 20201230; Test Name: Covid; Test Result: Negative

Allergies:

Symptoms: Cold/ cold like symptoms; Sore throat; Congested/ sore throat; Sore arm; I was hurting for a day; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscular on left arm at single dose for COVID-19 immunization on 23Dec2020 at 61-year-old. No medical history or concomitant medication. Yesterday (30Dec2020), the patient woke up with a sore throat, it was like getting cold with a sore throat, congested, the patient had cold like symptoms, seemed like the patient was getting a cold. The patient just took decongestant medication. After waking up this morning (31Dec2020) the patient did not have taken anything. The patient got tested for COVID (for antigen not a PCR) yesterday (30Dec2020) and was negative. The patient did not have got any fever, just sore arm a week ago (Dec2020). She was hurting for a day and then she was good, everything good. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 0924924
Sex: M
Age:
State: FL

Vax Date: 12/21/2020
Onset Date: 12/28/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: lost his sense of smell/cannot smell anything; Sore throat; sweating a lot; Fever; chills; body felt cold; This is a spontaneous report from a contactable consumer (patient) reported that a 40-year-old male patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: EH9899 and Expiration Date: 31Mar2021) via an unspecified route of administration on 21Dec2020 14:30 at single dose in left arm for Precaution (covid-19 immunization). NDC number of Pfizer COVID Vaccine: 59267-1000-2. The patient's medical history and concomitant medications was reported as none. The patient works in a hospital and got the first shot. Before he got the vaccine, he did not have any symptoms and felt great. They told him he may feel some symptoms for a couple of days. Now, he was getting symptoms of COVID 2 nights ago (around 20:00 28Dec2020) such as fever, chills, body felt cold, fever. Last night (30Dec2020) when he slept, he sweated a lot. Maybe it is one of the reasons. He did not have a fever, but he sweated a lot. He felt like his shirt was wet in the morning. He also had sore throat and lost his sense of smell on 06:00 31Dec2020. It is weird. He never had that before. He doesn't know what the do. If it was normal or it was symptoms of COVID. Second one will be on 12Jan2020. Should he get tested for COVID. Wanted to know if he should get the second dose. The outcome of events, fever, chill, felt cold, sweating a lot was recovering. The outcome of sore throat and cannot smell anything was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0924925
Sex: U
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: nurse got Covid after getting the vaccine; nurse got Covid after getting the vaccine; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that a nurse got Covid after getting the vaccine. The reporter wanted to know if the chills were common. She wanted to know if it is okay to feel chills every now and then. She wanted to know how people would know if they are positive when getting the vaccine. The outcome of the event was unknown. Information about the lot/batch number has been requested.; Sender's Comments: Based on the limited information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information

Other Meds:

Current Illness:

ID: 0924926
Sex: F
Age:
State: MI

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/07/2021
Hospital:

Lab Data:

Allergies:

Symptoms: a strong, whole body heat, and flushing; a strong, whole body heat; tachycardic; Palpitations; This is a spontaneous report from a contactable Nurse(patient). This Nurse reported for similar events for 6 patients. This is 1st of 6 reports. A 49-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at the 49 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The registered nurse and 5 other registered nurses she worked with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a weird reaction right after she was injected with the COVID-19 Vaccine. She had a strong, whole body heat, and flushing. She said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. The patient said she had no other symptoms after receiving the COVID-19 Vaccine. The reporter said there were 5 other registered nurses that received the COVID-19 Vaccine at the same time and had the same exact symptoms she experienced. The reporter said stated the registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter stated she did not know if the patient had received any other vaccines at the same time as the COVID-19 Vaccine, and if the patient had received any other vaccines within the last 4 weeks. The patient works at a hospital but didn't received any medical treatment. The patient just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association. Case will be reevaluated based on follow-up information ,Linked Report(s) : US-PFIZER INC-2021001363 same reporter/drug/event, different patient.;US-PFIZER INC-2021001364 same reporter/drug/event, different patient.;US-PFIZER INC-2021001195 same reporter/drug/event, different patient.;US-PFIZER INC-2021001204 same reporter/drug/event, different patient.;US-PFIZER INC-2021001329 same reporter/drug/event, different patient.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm