VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1004402
Sex: M
Age:
State: TX

Vax Date: 01/16/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: extreme chills; awful headache; body aches; severe sweating; low oxygen; 102 degree temperature; 120 pulse rate(abnormal for me); my arm felt like it was broken (9/10), but no other problems. Twelve hours later, the pain was still 9/10".; shoulder still sore; This is a spontaneous report from a contactable 58-year-old female consumer reporting for herself A 58 years old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249) on 16Jan2021 at 23:30 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. The patient did not have medical history. Concomitant medications were not reported. The patient reported at inoculation, the injection was high on right arm, and his arm felt like it was broken (9/10), but no other problems. On 17Jan2021 twelve hours later, the pain was still 9/10 so the patient put two heating pads on the site of injection. On the same day (17Jan2021) shortly thereafter, patient also experienced extreme chills, low oxygen (94), 102 degree temperature, 120 pulse rate (abnormal for him), awful headache, body aches, then severe sweating. This peaked 8 hours later and it was gone within 24 hours. No Treatment was given for the events. At the time of rh reporting the patient informed his shoulder was much better, but still sore. Patient also informed he was positive for SARS-Cov-2 from 07Dec2020 to 28Dec2020.He had mild symptoms. The patient recovered with sequel from the events on an unspecified date.

Other Meds:

Current Illness:

ID: 1004403
Sex: F
Age:
State: NC

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: swelling of (most likely) lymph nodes in left armpit (same arm as vaccination); This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 20Jan2021 14:15 at SINGLE DOSE at Left arm for covid-19 immunisation . Medical history included basal cell carcinoma. Concomitant medication included l-arginine [arginine]. The patient experienced swelling of (most likely) lymph nodes in left armpit (same arm as vaccination) on 21Jan2021 17:00. No treatment for the event. The outcome of event was not recovered. Information on the lot/batch number has been requested.

Other Meds: L-ARGININE [ARGININE]

Current Illness:

ID: 1004404
Sex: F
Age:
State:

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: a "little bit" of headache; This is a spontaneous report from a Pfizer Sponsored program, received from a non-contactable consumer reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) , via an unspecified route of administration on 21Jan2021 as a SINGLE DOSE for COVID-19 vaccination. The patient's medical history included migraines from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 21Jan2021, the patient experienced a "little bit" of headache, but it is nothing unusual to her since she has always had migraines in the past. She said apart from that, she is not experiencing any side effects as of the moment. If in case she experiences any more headaches, she wants to know if it would be okay to take ibuprofen (ADVIL), Ibuprofen or acetaminophen (TYLENOL) to treat it. The clinical outcome of a "little bit" of headache was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1004405
Sex: M
Age:
State: CA

Vax Date: 01/11/2021
Onset Date: 01/14/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: dysaesthesia in the right arm (upper arm on the posterior aspect and forearm) and right hip/thigh; the right shoulder, right elbow, and right hip joints are mildly sore; pins and neeles sensation; This is a spontaneous report from a contactable consumer who is the patient. A 39-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686) intramuscularly in the right arm on 11Jan2021 at 8:30 (at the age of 39-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included hypertension and migraines. The patient does not have allergies to medication, food, or other products. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EK5730) in the right arm on 18Dec2020. Prior to vaccination, the patient had not been diagnosed with COVID-19. The patient was administered the vaccine in a Hospital. The patient's concomitant medications were not reported. Beginning on 14Jan2021 the patient started to experience dysaesthesia in the right arm (upper arm on the posterior aspect and forearm) and right hip/thigh. Discomfort feels like pins/needles sensation anytime skin is touched lightly (such as blankets, clothing etc). As of the reporting date, the symptoms persist. In addition, the right shoulder, right elbow, and right hip joints are mildly sore which also are persistent. No perceived muscle weakness and no associated numbness. Treatment was not received for the events. Lab data included two post vaccination COVID 19 tests. A PCR nasal swab test on 11Jan2021 and a PCR nasal swab test on 17Jan2021 both of which were negative for COVID-19. The clinical outcomes of dysaesthesia, joint soreness and pins and needles were reported as not recovered.

Other Meds:

Current Illness:

ID: 1004406
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: little nervous; little more scary for her as she is kind of scared of anaphylaxis, normal anxiety range; sensation of throat fullness and tingling with a strange itchy feeling; sensation of throat fullness and tingling with a strange itchy feeling; sensation of throat fullness and tingling with a strange itchy feeling; allergic reaction; This is a spontaneous report from a contactable psychiatrist reported for herself and another physician and consumer. This female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 30Dec2020 as a single dose for COVID-19 immunisation. Medical history included occupational exposure to COVID-19. The patient had been taking care of patients as a psychiatrist throughout this COVID-19 pandemic. Concomitant medications were not reported. The patient experienced a sensation of throat fullness and tingling with a strange itchy feeling about 10 minutes after the vaccine was given on 30Dec2020. The patient was monitored in the emergency room (ER) for six hours and did not need to give epinephrine (EPIPEN) or antihistamines and she was sent home. By the next morning, her throat was back to normal. The patient reported that she knew at least three other people who had the same reaction and had heard others too (AER 2021058666). The patient stated that she had read a bunch and there were differing theories on whether this is complement mediated, IgE or something else. The patient and her immunologist/allergist are trying to figure out how to go about next dose. Her immunologist/allergist wanted to do a skin test but it is impossible to get a sample of the second shot to do that. The patient and her immunologist/allergist were very reluctant for her to get it because of the uncertainty about the possibility of increased allergic reactions from the second shot. The patient is supposed to get next dose tomorrow 22Jan2021, but she is getting a little nervous about how much is unknown. At the same time, she is face-to-face with patients daily and does worry about her exposures. The patient wanted to get Pfizer opinion on all this if company think it would be worthwhile to "risk it" and just get the dose under observation with epinephrine around or if waiting for more information would be better. The patient stated that she was not an anxious person, but this one is a little more scary for her as she is kind of scared of anaphylaxis (which as a psychiatrist, she would put in normal anxiety range). Another reporter also mentioned the allergic reaction and asked if there is any possibility of getting a small sample of the second shot for skin testing and ask for advice on what the patient should do. The outcome of the events sensation of throat fullness and tingling with a strange itchy feeling and allergic reaction was resolved. The outcome of the other events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004407
Sex: M
Age:
State:

Vax Date: 01/11/2021
Onset Date: 01/18/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: One week after the second vaccine I developed Bell's Palsy; This is a spontaneous report from a contactable other health professional reported for himself. A 30-year-old male patient received second dose of bnt162b2, via an unspecified route of administration in left arm on 11Jan2021 11:00 at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included terbinafine, cetirizine hydrochloride (ZYRTEC), multivitamin. The patient previous received first dose of bnt162b2, via an unspecified route of administration in right arm on 21Dec2020 11:00 for covid-19 immunization. The patient experienced one week after the second vaccine, he developed bell's palsy on 18Jan2021 with outcome of not recovered. The event was reported as non-serious. The adverse event result in a visit to emergency room/department or urgent care. Treatment Prednisone, valacyclovir was received for the adverse event. Facility where the most recent COVID-19 vaccine was administered: School or Student Health Clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported event Bell's palsy. 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: TERBINAFINE; ZYRTEC

Current Illness:

ID: 1004408
Sex: F
Age:
State: HI

Vax Date: 01/20/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: has a very stiff neck; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 (at the age of 82-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on an unspecified date (at an unspecified age). On an unspecified date in Jan2021, the patient had a very stiff neck. The reporter inquired if the patient can take over the counter pain medication for the very stiff neck. The clinical outcome of the very stiff neck was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004409
Sex: F
Age:
State: LA

Vax Date: 01/13/2021
Onset Date: 01/18/2021
Rec V Date: 02/05/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: She thinks she had a delayed anaphylactic shock she was definitely in shock; hypothermic; her adrenal glands are over compensating, working over load; she was having diarrhea; throwing up; she went from cold to profusely sweating back to having chills; she went from cold to profusely sweating back to having chills; she had no blood to her extremities; severe abdominal cramps; headache; her body is just weak; she was feeling dizzy; Her legs were cramping; her heart was racing fast; her lactic acid was really high; This is a spontaneous report from a contactable Nurse. A 53-years-old female patient receive the first dose of bnt162b2 (BNT162B2; Lot # EL3249) vaccine , via an unspecified route of administration in the right deltoid on 13Jan2021 15:55 at single dose for Covid-19 immunisation . Medical history included hypertonic bladder from an unknown date., drug hypersensitivity from an unknown date , migraine from an unknown date. She had migraines. Concomitant medication included solifenacin succinate (VESICARE), buspirone hydrochloride (BUSPAR), spironolactone (SPIRONOLACTONE). The patient previously took flu vaccine VII, bactrim and experienced drug hypersensitivity. The patient stated she thinks she had a delayed anaphylactic shock she was definitely in shock on an unknown date with outcome of unknown , hypothermic on an unspecified date with outcome of unknown , her adrenal glands are over compensating, working over load on an unspecified date with outcome of unknown , she was having diarrhea on an unspecified date with outcome of not recovered , throwing up on an unspecified date with outcome of unknown , she went from cold to profusely sweating back to having chills on an unspecified date with outcome of unknown , she had no blood to her extremities on an unspecified date with outcome of unknown , severe abdominal cramps on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of not recovered , her lactic acid was really high on 18Jan2021 with outcome of unknown , her body is just weak on an unspecified date with outcome of not recovered , her heart was racing fast on 18Jan2021 with outcome of unknown , she was feeling dizzy on 22Jan2021 with outcome of unknown , her legs were cramping on 19Jan2021 with outcome of unknown. The patient was hospitalized because of the events from 16Jan2021 to 17Jan2021. The patient underwent lab tests and procedures which included blood lactic acid: high on unknown date, chest x-ray: unknown results on unknown date, computerised tomogram: unknown results on 18Jan2021 , electrocardiogram: unknown results on unknown date. The patient was given fluids, Toradol and Xanax to treat the events. Further information has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events 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: VESICARE; BUSPAR; SPIRONOLACTONE

Current Illness:

ID: 1004410
Sex: F
Age:
State: MD

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: the arm was very sore all the way down to her elbow; Queasy; pasty frequent stool; pasty frequent stool; the outside of her arm where the vaccine was put hurt that day; This is a spontaneous report from a contactable consumer. A 81-year-old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1284), at single dose into the left arm on 16Jan2021 at 12:30PM for COVID-19 immunization. Concomitant drugs included Levothyroxine 0.100mg once daily by mouth taking for years for thyroid and a week and half before the vaccine administration, she had a cortisone shot in her hip for bursitis but it didn't work, it was the first time she has had one in a long time. The patient reported that on 16Jan2021 the outside of her arm where the vaccine was put hurt that day, but then the next day the arm was very sore all the way down to her elbow. But it was bad, she couldn't roll in bed form the pain. Then she woke up on 17Jan2021 queasy like morning sickness that didn't go away until 21Jan2021. Adds she also noticed that day she was having more frequent and pasty stools. Mentions she expected her arm to be sore because with the second shingles vaccine her arm was sore. States this was years ago and she did not have any product or information for the shingles vaccine. The patient is scheduled for the second dose on 06Feb2021. Mentions she lives in a continuous care facility and they will give her the shot. The event arm hurt recoverd on 20Jan2021, the other events resolved on 21Jan2021.

Other Meds: LEVOTHYROXINE; CORTISONE

Current Illness:

ID: 1004411
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides/ hurting; right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides/ hurting; This is a spontaneous report from a contactable consumer reporting for self. An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After the hurting started on an unspecified date, she had taken ibuprofen and tramadol. , Her right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides; she wanted to know if there is anything she could do to eliminate that or make it less consuming. She wanted to know if there was anything she could do to make the hurting less strenuous or if she can lay or walk a certain way to make it feel better. The end of the second phase of the vaccine is coming on 07Feb2021 and she needed to know if she should go ahead and take that. She hadn't been driving a car while this was going on because she was afraid of running into something. The event was reported as non-serious. The outcome of the event right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides/hurting was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1004412
Sex: F
Age:
State: GA

Vax Date: 01/15/2021
Onset Date: 01/16/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: Next day after the shot i feel a pain under my left arm. Days later the pain increase and i think is lymphoma; Next day after the shot i feel a pain under my left arm. Days later the pain increase and i think is lymphoma; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL1283, expiry: unknown), via an unspecified route of administration in the left arm on 15Jan2021 07:00 at a single dose for COVID-19 immunization. The patient has no medical history and no known allergies. The patient has no Covid prior to vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient mentioned that the next day after the shot (16Jan2021 at 05:30), the patient feel a pain under her left arm; days later, the pain increased, and she thinks it is lymphoma. The patient was not tested for Covid post vaccination. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1004413
Sex: F
Age:
State: NY

Vax Date: 01/19/2021
Onset Date: 01/22/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: have two discoloration in my right thumb one black long line and one red line side by side around 1 and a half inches long and behind it is a circular black and discoloration; This is a spontaneous report from a contactable other hcp. A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3247), via an unspecified route of administration on the right arm on 19Jan2021 12:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, supraventricular tachycardia and hearing loss from an unknown date and unknown if ongoing. Concomitant medication included amlodipine (AMLODIPINE) and metoprolol tartrate (METOPROLOL TARTRATE). On 22Jan2021 05:00 AM, the patient stated, "I have two discoloration in my right thumb one black long line and one red line side by side around 1 and a half inches long and behind it is a circular black and discoloration." No treatment was received for the events. The outcome of the event was not recovered.

Other Meds: AMLODIPINE; METOPROLOL TARTRATE

Current Illness:

ID: 1004414
Sex: M
Age:
State: NC

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Minor soreness at injection site. Lasted about 48 hours; Minor sweats day of vaccination. Lasted 5 hours; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 19Jan2021 09:00 at SINGLE DOSE on Arm Left for covid-19 immunisation. The patient medical history was not reported. No covid prior vaccination. No other vaccine in four weeks. Known allergies: No. Had other medications in two weeks. The patient experienced minor soreness at injection site. lasted about 48 hours since on 19Jan2021 with outcome of recovered on 21Jan2021, minor sweats day of vaccination. lasted 5 hours on 19Jan2021 with outcome of recovered in Jan2021. No treatment received. No covid tested post vaccination.

Other Meds:

Current Illness:

ID: 1004415
Sex: M
Age:
State: NY

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: soreness in his arm; This is a spontaneous report from a contactable consumer. An adult male patient received first single dose of BNT162B2 (Pfizer/BioNTech, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on Jan2021 for COVID-19 immunization. The patient had no relevant medical history. The patient did not have covid prior vaccination. The patient's concomitant medications were not reported. The patient reported after his first shot he had soreness in his arm (onset date: Jan2021). The patient was not covid tested post vaccination. The outcome of the event was unknown. Information on the lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1004416
Sex: F
Age:
State: SC

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: administration date= 04Jan2021/Other vaccine same date vaccine date=21Jan2021; Lightheaded/Dizzy; vomiting; This is a spontaneous report from a contactable other HCP. This 24-year-old female other HCP (no pregnant) received 2nd dose of BNT162B2 (lot number=EL3249) on 21Jan2021 at single dose on Left Arm for covid-19 immunization. Medical history was Total colonic Hirschsprung's disease, POTS, asthma, chronic migraines, recurrent pneumonia, GERD. Historical Vaccine was 1st dose of BNT162B2 (Lot number= EL1284 on 04Jan2021 09:30 AM on Left arm). Known allergies: Erythromycin, azithromycin (Z-PACK), metoclopramide (REGLAND), diphenhydramine hydrochloride (BENADRYL). Concomitant drug included topiramate (TOPAMAX), esomeprazole sodium (NEXIUM), famotidine (PEPCID), ondansetron (ZOFRAN), budesonide/formoterol fumarate (SYMBICORT). No other vaccine in four weeks. Patient experienced Lightheaded, dizzy, vomiting on 21Jan2021 11:15 PM with outcome was recovered. No treatment. No Covid prior vaccination. No covid tested post vaccination. No follow-up attempts possible. No further information expected.

Other Meds: TOPAMAX; NEXIUM; PEPCID; ZOFRAN; SYMBICORT

Current Illness:

ID: 1004417
Sex: M
Age:
State:

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: severe diarrhea; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter was to report a possible side effect. The patient experienced severe diarrhea in Jan2021. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004418
Sex: F
Age:
State: NJ

Vax Date: 01/20/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: chills; muscle ache; joint pain; sweat; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received second single dose of BNT162B2 (Solution for injection, lot number: EL3247, exp date not reported), via an unspecified route of administration (Anatomical location: Arm Right)on 20Jan2021 15:00 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. The patient previously took first single dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunization. The patient experienced chills, muscle ache, joint pain, and sweat on Jan2021. The events were considered as non-serious. The outcome of events was unknown.

Other Meds:

Current Illness:

ID: 1004419
Sex: F
Age:
State: TX

Vax Date: 01/02/2021
Onset Date: 01/08/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: developed COVID symptoms/diagnosed positive in Covid19/ tested positive for Covid; developed COVID symptoms/diagnosed positive in Covid19/ tested positive for Covid; This is a spontaneous report from a contactable nurse (patient). This nurse reported same event for two patients (patient and her husband), this is the first of two reports, the report for patient herself. A 69-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL0142, expiration date unknown), via an unspecified route of administration in arm (reported as deltoid) on 02Jan2021 at single dose for COVID-19 immunization. The patient denied relevant medical history. Concomitant medications were not reported. The patient got her first dose on 02Jan2021, and on 08Jan2021 developed COVID symptoms. On 11Jan2021, she tested positive for COVID-19/diagnosed positive in COVID-19. The reporter nurse think they were exposed sometime at that pharmacy, she mean there was a lot of people in the line. Tomorrow (unspecified) was supposed to be second dose and his family physician didn't know if he should get that second dose. The outcome of events was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021064940 Same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 1004420
Sex: F
Age:
State: PA

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Aching joints; severe headache; blotchy skin on arms; This is a spontaneous report from a contactable other hcp reported for herself. A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1282), via an unspecified route of administration on the left arm on 21Jan2021 11:15 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included sertraline (SERTRALINE). The patient previously took the first dose of bnt162b2 (lot number: EL0142) for covid-19 immunization on 31Dec2020 and diflucan and experienced drug hypersensitivity. The patient experienced aching joints, severe headache, blotchy skin on arms on 22Jan2021 04:00 AM . The patient underwent lab tests and procedures which included sars-cov-1 test: negative on 22Jan2021. No treatment was received for the events. The outcome of the events was not recovered.

Other Meds: SERTRALINE

Current Illness:

ID: 1004422
Sex: M
Age:
State: KY

Vax Date: 12/15/2020
Onset Date: 01/05/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: Headache; Sweating for approx 12-24 hours; This is a spontaneous report from a contactable healthcare professional (patient himself). A 28-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EH9899, expiry date: Mar2021), intramuscular in the left arm on 15Dec2020 14:45 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included Type II diabetic, irregular heartbeat (Sinus Arrhythmia), and gout. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included atenolol. The patient previously had allergy with lisinopril. On 05Jan2021 23:30, the patient experienced headache and sweating for approximately 12-24 hours. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone and Benadryl as treatment. The outcome of the events was recovering. The case was considered non-serious. No follow-up attempts are possible. No further information is expected.

Other Meds: ATENOLOL

Current Illness:

ID: 1004423
Sex: F
Age:
State: MO

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: 102.8 F fever; aches in muscles and joints; aches in muscles and joints; chills; headache; This is a spontaneous report from a contactable consumer, the patient. This 51-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EL9262), first dose, via an unspecified route of administration in the left arm on 21Jan2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 vaccination. Medical history included migraine from an unknown date and unknown if ongoing, cow's milk protein allergy from an unknown date and unknown if ongoing, lactose allergy from an unknown date and unknown if ongoing, peppermint allergy from an unknown date and unknown if ongoing and Penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included butalbital (BUTALBITAL), zolmitriptan (ZOMIG), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), benzonatate (BENZONATATE) and levocetirizine dihydrochloride (XYZAL). The patient previously took bactrim and experienced drug hypersensitivity, ultram er and experienced drug hypersensitivity. Prior to the vaccination, the patient was 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. On 21Jan2021 at 04:00, the patient experienced 102.8 degree Fahrenheit fever, aches in muscle and joints, headache and chills. No therapeutic measures were taken as a result of the events. The clinical outcome of the 102.8 degree Fahrenheit fever, aches in muscle and joints, headache and chills was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds: BUTALBITAL; ZOMIG; FLONASE [FLUTICASONE PROPIONATE]; BENZONATATE; XYZAL

Current Illness:

ID: 1004424
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: side effects he had: nausea; side effects he had: "warm"; side effects he had: "feel lousy"; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), 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 patient was asking if he could take Tylenol or Motrin to treat his side effects after receiving his 1st dose of the vaccine. The side effects he had included: nausea, "warm", and "feel lousy". The reporter said that the vaccination location told him that most people experience the symptoms that he was feeling. The reporter said he already spoke with another nurse. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004425
Sex: F
Age:
State: NC

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Sore arm; fatigue; This is a spontaneous report from a contactable consumer reported for herself. A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3247), via an unspecified route of administration on the left arm on 16Jan2021 07:00 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included sertraline hydrochloride (ZOLOFT), probiotics (PROBIOTICS), lecithin (LECITHIN) and multivitamin. The patient experienced sore arm and fatigue on 16Jan2021 18:00. No treatment was received for the events. The outcome of the events was recovered on an unspecified date.

Other Meds: ZOLOFT; PROBIOTICS; LECITHIN

Current Illness:

ID: 1004426
Sex: M
Age:
State: NY

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Low grade temperature (99.1 degree F); Tiredness; This is a spontaneous report from a contactable healthcare professional (patient himself). A 26-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 15:45 at single dose for covid-19 immunization. The patient was vaccinated in the workplace clinic. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 14:15, the patient experienced low grade temperature (99.1 degree F) and tiredness. No treatment was received for the adverse events. The outcome of the events was recovered on 22Jan2021 (time unknown). The case has been considered non-serious.

Other Meds:

Current Illness:

ID: 1004427
Sex: F
Age:
State: MA

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: nausea; body aches; headache; fatigue; tingling in both hands (and fingers); crushing depression; This is a spontaneous report from a contactable healthcare professional. A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration at the left arm on 19Jan2021 13:45 at single dose for COVID-19 immunisation. Medical history included osteoarthritis, restless legs syndrome, rubber sensitivity (latex allergies), and COVID-19. The patient was diagnosed with COVID-19 prior to vaccination. 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. The patient was vaccinated at a hospital. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included ropinirole. On 19Jan2021 14:15, the patient experienced nausea, body aches, headache, fatigue, tingling in both hands (and fingers) and crushing depression. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.

Other Meds: ROPINIROLE

Current Illness:

ID: 1004428
Sex: F
Age:
State:

Vax Date: 01/18/2021
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: experienced urinary tract infection; Medical history included multiple sclerosis, immune suppressants a month ago for multiple sclerosis; Medical history included multiple sclerosis, immune suppressants a month ago for multiple sclerosis; This is a spontaneous report from a non-contactable consumer reported for herself. This female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 18Jan2021 as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. Concomitant medications were not reported. The patient previously took immune suppressants a month ago for multiple sclerosis. The patient reported that she had first dose of the COVID-19 vaccine on 18Jan2021, and she had some reactions similar to those she usually got when she took steroids. The patient experienced urinary tract infection. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1004429
Sex: M
Age:
State: FL

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Sharp pain in his heart; Wild palpitations; Extreme erratic heart beat; wiped out; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1248), via an unspecified route of administration on 11Jan2021 at single dose at left arm for covid-19 immunisation. Medical history included Lyme's disease from 09Jun2018 and ongoing, ongoing heart issues, cholesterol lowering and swelling (He was on a water pill for swelling). Concomitant medication included atenolol for heart medication, pitavastatin calcium (LIVALO) for cholesterol lowering. Patient was calling to report a negative reaction with Covid-19 vaccine. Four hours after the injection he laid down in bed and was relaxing on 11Jan2021. He felt a sharp pain in his heart. It was about 1 to 1.5 inches to the right of his nipple. It felt like a knife being jabbed in his chest. This only happened once. His heart was having wild palpitations. He had an extreme erratic heart beat lasting 30-40 seconds. It was terrifying. He had a lot of irregular heart beats for 3-4 days. He was wiped out and unable to get out of bed for 5 days. He had an MRI on 21Jan2021. He was waiting on the results. The erratic heart beats come and go. They were not as pronounced as the first week. He was not getting the second dose. He had not had a flu shot for the last 3 years. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. Outcome of event sharp pain in his heart recovered with sequel on 11Jan2021, wild palpitations was recovered in Jan2021, extreme erratic heart beat was recovering, wiped out was recovered with sequel on 16Jan2021. The report was considered as non-serious.

Other Meds: ATENOLOL; LIVALO

Current Illness: Heart disorder; Lyme's disease

ID: 1004430
Sex: F
Age:
State: CA

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: headache; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), glucose tolerance impaired (pre-diabetic), lung cancer, and lymphoma. 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. The patient was vaccinated at a nursing home/senior living facility. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient experienced headache on 19Jan2021. No treatment was received for the adverse event. Clinical outcome of event was recovered on an unspecified date. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004431
Sex: F
Age:
State: NC

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Sore at injection site; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the left arm on 06Jan2021 15:30 at a single dose for COVID-19 immunization. The patient was vaccinated in a doctor's office/urgent care. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient is not pregnant at the time of vaccination. On 06Jan2021 16:00, the patient experienced sore at injection site with outcome of recovered on unspecified date in Jan2021. The patient did not receive treatment for the reported event. The case was considered non-serious. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004432
Sex: F
Age:
State: MO

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Fainted; Dizziness; Heart racing; This is a spontaneous report from a contactable consumer reported for herself. A 22-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 15:45 at single dose in left arm for COVID-19 immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), escitalopram oxalate (LEXAPRO), spironolactone and Birth control product. The patient experienced fainted morning after 1st dose with dizziness and heart racing on 22Jan2021 06:45 - had to go to ER. The patient received anti-nausea and heart monitor as treatment for the adverse event. Events outcome was unknown. Information on the lot/batch number has been requested.

Other Meds: VYVANSE; LEXAPRO; SPIRONOLACTONE

Current Illness:

ID: 1004433
Sex: F
Age:
State:

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tightness; numbness on the left side of [her] face, right under the eye; temporary rash she had on the left side of her face, under her cheek; toes crowded back; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose "on the left side" for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She stated feeling nauseous right after the shot and mentioned not eating breakfast. She described having bilateral leg paralysis which she also qualified as locked to the point where she could hardly walk. She added that her leg muscles were so tight that her toes crowded back. She then explained having numbness on the left side of her face, right under the eye and that her jaws felt locked, like a tightness. She specified she didn't know if she really felt tightness in her jaws because of the intensity of her bilateral leg paralysis. She then described a temporary rash she had on the left side of her face, under her cheek. She said her experience occurred two hours post injection on 21Jan2021 and was resolved in Jan2021 after taking a muscle relaxer. She asked if shellfish is in the vaccine. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004434
Sex: M
Age:
State: NE

Vax Date:
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: he is disabled and has congestive heart failure.; This is a spontaneous report from a contactable consumer (patient). A male patient (age: 74, unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated he was disabled and had congestive heart failure. The patient stated that he read the CDC had decided to only give one shot, everything he read on the website saying designed for 2 doses of the covid 19 vaccine. He received his shot and they might not be able to give 2 doses. The outcome of event was unknown. Information on the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004435
Sex: F
Age:
State: MI

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: nausea; chills; her lips became really chapped; This is a spontaneous report from a non-contactable consumer. This female consumer (patient) with unspecified age reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization at hospital. The patient medical history and concomitant medications were not reported. Patient did not experience any problems there after waiting 15 minutes. When she got home, she started to have chills and her lips became really chapped on 21Jan2021. This morning 22Jan2021, she's having some chills and nausea. She was taking diphenhydramine (BENADRYL). Outcome of events was unknown. No follow-up attempts are possible. Information about batch/ lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1004436
Sex: F
Age:
State: WA

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (BNT162B2, lot number EL3302) , via an unspecified route of administration on 21Jan2021 12:00 at single dose on left arm for covid-19 immunisation. Medical history included none. Concomitant medication included citalopram hydrobromide (CELEXA), zolpidem tartrate (AMBIEN). No other vaccine in four weeks. The patient experienced diarrhea on 22Jan2021 08:00. No treatment received. No covid prior vaccination, no covid tested post vaccination, no known allergies. The outcome of the event was not recovered.

Other Meds: CELEXA [CITALOPRAM HYDROBROMIDE]; AMBIEN

Current Illness:

ID: 1004437
Sex: F
Age:
State: WI

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: She passed out.; This is a spontaneous report from a contactable consumer (parent). A 17-year-old female patient (daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL1284) on 22Jan2021 11:45 AM at left arm at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. No known allergies. Patient was not pregnant. Patient did not have COVID prior vaccination, and did not have other vaccine in four weeks, did not other medications in two weeks. The patient experienced passed out on 22Jan2021 12:00 PM. Treatment included they had her lay on the ground with her knees up and cold compresses. Patient did not test COVID post vaccination. The outcome of event was recovering.

Other Meds:

Current Illness:

ID: 1004438
Sex: M
Age:
State: MO

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: bad headache; chills; This is a spontaneous report from a contactable consumer. This consumer reported for a 26-year-old male patient who received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown) on 21Jan2021 at 12:30 PM via unknown route of administration at single dose (at the age of 26 years old) for covid-19 immunisation. Relevant medical history and concomitant medication were not provided. It was unknown if patientrecived any other vaccines within 4 weeks prior to the COVID vaccine. On unknown date, the patient reported that he got a bad headache at night which has become cyclical. He also got chills every once in a while. The events outcome was unknown. It was unknown if patient received any treatment for events. Since the vaccination, it was unknown if the patient has 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: 1004439
Sex: F
Age:
State: NC

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: cancerous cells; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her first dose of PFIZER-BIONTECH COVID-19 VACCINE on 14Jan2021. She had a surgical procedure Wednesday 20Jan2021, and was prescribed a cephalosporin antibiotic for 7 days post-procedure precautionary remove cancerous cells somebody suggested, it was a doctor. She was asking if there are any drug interactions between the antibiotic and the vaccine. Also, a doctor suggested that she take a dose of ibuprofen prior to her second vaccine dose on 05Feb2021. It was also reported the patient had a little surgical procedure with the Dermatologist this week (in Jan2021) and she just wanted to know if the antibiotic, Cefadroxil, has any contraindications that would compromise her vaccine. She had to take it for 7 days and it was to prevent bacterial infections. It was a procedure on her leg and she was also given an antibiotic cream also to help. The patient felt it was more important for her with having this vaccine and that was why she was calling. The event outcome was unknown. Information on the Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1004440
Sex: F
Age:
State: NC

Vax Date: 01/14/2021
Onset Date: 01/18/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Silver dollar sized swelling and redness around the injection site for 4 days; Silver dollar sized swelling and redness around the injection site for 4 days; Silver dollar sized swelling and redness around the injection site for 4 days. After 4 days the redness subsided but a knot remains under the skins surface with heat to the touch and itching; Silver dollar sized swelling and redness around the injection site for 4 days. After 4 days the redness subsided but a knot remains under the skins surface with heat to the touch and itching; Silver dollar sized swelling and redness around the injection site for 4 days. After 4 days the redness subsided but a knot remains under the skins surface with heat to the touch and itching; This is a spontaneous report from a contactable Other Health Professional (patient). A 32-years-old female patient received first dose bnt162b2 (BNT162B2, lot: EL3247), intramuscular on 14Jan2021 11:15 at SINGLE DOSE on Arm Left for covid-19 immunisation. The patient medical history was not reported. Pregnant: No. No other vaccine in four weeks. The patient's concomitant medications were none. The patient experienced Adverse event: Silver dollar sized swelling and redness around the injection site for 4 days. After 4 days the redness subsided but a knot remains under the skins surface with heat to the touch and itching since 18Jan2021. The event outcome of redness around the injection site was recovered on 22Jan2021, outcome of other events were not recovered. No treatment received.

Other Meds:

Current Illness:

ID: 1004441
Sex: F
Age:
State: NY

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Head hurting - constant achiness; received other vaccine on 20Jan2021 on the left arm; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 10:00 at single dose on the left arm for COVID-19 immunization. The patient medical history included allergies: Milk. Patient took migraine medications in two weeks. Facility type vaccine was hospital. Patient was not pregnant. The patient received other vaccine on 20Jan2021 on the left arm. The patient experienced head hurting - constant achiness on 20Jan2021 16:00. The patient underwent lab tests and procedures which included Nasal Swab: Negative on 05Jan2021. COVID tested post vaccination. No treatment received. Outcome of the event head hurting - constant achiness was not recovered. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1004442
Sex: F
Age:
State: MI

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: Person indicated that they felt lethargic and had a headache.; Person indicated that they felt lethargic and had a headache.; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, number: EC0142), via an unspecified route of administration on 20Jan2021 at single dose in arm left for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. The patient previously received the first dose of BNT162B2 (lot number: EC 1284) in Left arm on 30Dec2020 for COVID-19 immunisation. The patient indicated that they felt lethargic and had a headache on 21Jan2021. The patient was not pregnant at the time of vaccination. COVID was not tested post vaccination. There was no treatment received for the event. Patient was recovered on an unspecified date in Jan2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1004443
Sex: M
Age:
State: AZ

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Scratchy throat; Sinus; Head cold symptoms; He experienced drainage and flowing; His total left arm, where he got the vaccine, was sore all the way down; He felt light headed; Blurry vision; This is a spontaneous report from a contactable consumer (patient). This male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown) on 18Jan2021 via unknown route of administration at single dose for covid-19 immunisation. Relevant medical history and concomitant medication were not provided. The patient reported that he received the covid vaccine on Monday, 18Jan2021, at which point he felt light-headed and blurry vision. He was kept for 30 minutes until it subsided. On Tuesday, 19Jan2021, his total left arm, where he got the vaccine, was sore all the way down. On Wednesday, 20Jan2021, he experienced drainage and flowing for which he took Benadryl which helped overnight. Yesterday, 21Jan2021 he reported heavy drainage, sinus or head cold symptoms. Today, 22Jan2021, he reported a scratchy throat. The outcome for events light-headed and blurry vision was recovered. The outcome for other events was unknown. The patient inquired as to what to do about his side effects after receiving the first dose of Covid-19 vaccine. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1004444
Sex: F
Age:
State:

Vax Date: 01/18/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: Diarrhea; headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose bnt162b2 (Pfizer-Biontech covid-19 vaccine), via an unspecified route of administration on 18Jan2021 in the afternoon at SINGLE DOSE for covid-19 immunisation. Medical history included Pulmonary fibrosis, lung infection. Concomitant medication included azithromycin (AZITHROMYCIN) on Mondays, Wednesdays and Fridays to Preventative for lung infection due to Pulmonary fibrosis, ibuprofen (IBUPROFEN) for Pulmonary fibrosis and other problems, had not taken any Ibuprofen since 16Jan2021. The patient had not had any symptoms other than a headache, so she is not sure if this was because of the vaccine or not; diarrhea on 20Jan2021. This consumer wanted to know how long before and after should get the Pfizer COVID-19 Vaccine shot do you have to stop taking Ibuprofen. She has Pulmonary fibrosis and other problems that she takes Ibuprofen for. She got the first dose of Pfizer COVID-19 Vaccine 18Jan2021. They did not tell her she would be getting the Pfizer COVID-19 Vaccine until the night before: 17Jan2021. She has not taken any Ibuprofen since Saturday night: 16Jan2021. She also mentioned that she had Diarrhea for 2 days in a row on Wednesday 20Jan2021 and Thursday 21Jan2021; Diarrhea is not too unusual for her because she takes Azithromycin 1 tablet 3 days/week continuously as preventative for lung infection due to her pulmonary fibrosis; she usually will get diarrhea on the day she takes the Azithromycin, but not on the days she does not-so the 2 days in a row of diarrhea she had 20Jan2021- 21Jan2021 she wanted to know if could be a possible side effect of the Pfizer COVID-19 Vaccine. The event outcome was unknown.

Other Meds: AZITHROMYCIN; IBUPROFEN

Current Illness:

ID: 1004445
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable Pharmacist. A healthcare worker of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive for covid-19 on an unspecified date with outcome of unknown. Information about Lot/Batch has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.

Other Meds:

Current Illness:

ID: 1004446
Sex: F
Age:
State: CT

Vax Date: 01/21/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Muscle pain; fatigue; This is a spontaneous report from a contactable consumer who is reporting for herself. A 26-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3247), via an unspecified route of administration left arm single dose on 21Jan2021 12:30 for covid-19 immunisation. No other vaccine was received in four weeks. The patient medical history was not reported. There were no concomitant medications. The patient experienced muscle pain on Jan2021, fatigue on Jan2021. No treatment received. The outcome was not recovered

Other Meds:

Current Illness:

ID: 1004447
Sex: F
Age:
State:

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Night sweats; This is a spontaneous report from a non-contactable consumer reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 12Jan2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced night sweats on 13Jan2021. The outcome was unknown No follow-up attempts are possible. Information on batch number cannot be obtained

Other Meds:

Current Illness:

ID: 1004448
Sex: F
Age:
State: TN

Vax Date: 01/22/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Diarrhea; This is a spontaneous report from a contactable consumer (patient's husband). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated patient received the first dose of the COVID 19 vaccine and now has severe diarrhea on an unspecified date in Jan2021. The reporter stated the patient hasn't been able to leave the bedroom for two hours and he gave the patient a dose of magnesium. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004449
Sex: M
Age:
State: MN

Vax Date: 01/09/2021
Onset Date: 01/11/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Guillain Barre syndrome/Symptoms started with 2 fingers tingling; This is a spontaneous report from a contactable nurse reporting for a patient. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via intramuscular on 09Jan2021 at single dose in left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular on 22Dec2020 at single dose in left arm at the age of 39-year-old for COVID-19 immunization. Reported he was diagnosed with Guillain Barre syndrome. Symptoms started with 2 fingers tingling on 11Jan2021. Progressively increasing in severity. Now had numb fingers and toes. Initiating IV therapy on 22Jan2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset. More information such as complete medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1004450
Sex: F
Age:
State: CO

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Transient bilateral lower extremity neuropathy; periorbal and facial neuropathy; severe low back pain; tinnitus; This is a spontaneous report from a contactable other health professional (patient) reporting for herself. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3248), intramuscular at left arm on 20Jan2021 at single dose for covid-19 immunization. Medical history was none. No pregnant at the time of vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 via intramuscular at left arm on 30Dec2020 for covid-19 immunization. Facility where the most recent COVID-19 vaccine administered was nursing home/senior living facility. The patient experienced transient bilateral lower extremity neuropathy, tinnitus, periorbital and facial neuropathy, severe low back pain on 20Jan2021 with outcome of unknown. No treatment was received for the adverse events. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1004451
Sex: M
Age:
State: MD

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Really bad headache/it has worsened; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 21Jan2021 14:15 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included fluoxetine hydrochloride (FLUOXETINE). The patient had a small headache in the morning on 22Jan2021, he ignored it, but now it was getting worse. The outcome of event was not recovered. Information on the lot/batch number has been requested.

Other Meds: FLUOXETINE [FLUOXETINE HYDROCHLORIDE]

Current Illness:

ID: 1004452
Sex: M
Age:
State: NC

Vax Date: 01/19/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis; severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis; severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis; lymphadenopathy as an MRI showed cervical lymph node enlargement; This is a spontaneous report from a contactable physician. A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The patient stated "Last Tuesday, I received my second vaccine. By Thursday I had severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis. MRI showed cervical lymph node enlargement." The patient was hospitalized for severe left upper girdle pain in my shoulder and neck. eventually i was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis (fasciitis) for 4 days. The patient underwent lab tests and procedures which included magnetic resonance imaging: cervical lymph node enlargement, pain assessment: 2-3 out of 10 on Jan2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported left upper girdle pain in shoulder and neck/ inflammatory fasciitis and the administration of the COVID-19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm