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: 1534075
Sex: M
Age:
State: NM

Vax Date: 07/14/2021
Onset Date: 07/01/2021
Rec V Date: 08/07/2021
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: generalized rash all over his body; had blotches and raised areas all over his body; woke him up early in the morning; big red raised welts; general malaise/he didn't feel so good; was feeling awful; He still has little pimples/bumps; Feet and palms itch; still has little bumps all over that they itch; This is a spontaneous report from a contactable consumer (patient's mother). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 14Jul2021 afternoon at the age of 46-year-old as dose 1, single for covid-19 immunisation from pharmacy. Medical history included patient was allergic to metals but not gold; silver metals will leave a blister where they rub the skin, if he wears a silver chain, he gets a rash around his neck, or if his pant button rubs on his belly, it will get blistered so he can't wear a belt. Patient drinks a lot of beer and smokes pot. Patient has a history of doing Meth and Cocaine 15 years ago but he got in to treatment. He broke his wrist and he is still in the healing process. Patient was on medication to reset the broken wrist, 6 months ago, and he was taking Ibuprofen for pain and a few doses of Oxycodone. Patient had no history of all previous immunization with the Pfizer vaccine and had no additional vaccines administered on same date of the BNT162B2. On 14Jul2021 right after he got the vaccine, he was complaining that he didn't feel so good, had general malaise and was feeling awful which all lasted for 4 days. On 16Jul2021 (a day and a half later), patient woke him up early in the morning and he was covered in the rash. He developed a generalized rash all over his body that was blotchy and had raised areas and big red raised welts. The reporter states she went in the afternoon to see him and he still had the rash and the worst of it lasted 24 hours. Patient took a cool shower, which helps in response to the events. The rash has since resolved however after 2 weeks, the patient still has little bumps all over that they itch. The patient mother tried to get him to go to urgent care, but he didn't want to go. The reporter stated that it was not an anaphylactic reaction, but rather an intermittent, not mild reaction. It was reported the welts are gone now (Jul2021), but he still has little pimples/bumps over his body and the bottom of his feet and the palms of his hands were itching after the rash went away. Patient did take warm bath and, no other treatment was revised for the patient in response to the events. The events did not result in emergency room or physician office visits. Patient wanted to know if he should receive the second dose of the vaccination series. Patient mother took pictures of the rash, but by the time she took it, it was already in the process of going away.The outcome of the events 'feet and palms itch', "still has little bumps all over that they itch", "still has little pimples/bumps" was not recovering, terminal insomnia was unknown, while the outcome of generalized rash all over his body, had blotches and raised areas all over his body, big red raised welts was recovered in Jul2021, and general malaise and feeling awful were recovered on 18Jul2021. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: IBUPROFEN; OXYCODONE

Current Illness: Broken wrist (he broke his wrist and he is still in the healing process.)

ID: 1534077
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: Feeling foggy, like he had "smoked weed" but has not.; Dizziness; "bad" dose of the vaccine/Knows it should not be used after 6 hours, should be at room temperature for 30 minutes; "bad" dose of the vaccine/Knows it should not be used after 6 hours, should be at room temperature for 30 minutes; This is a spontaneous report from a contactable consumer (Patient) received from Pfizer Sponsored Program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported "bad" dose of the vaccine/knows it should not be used after 6 hours, should be at room temperature for 30 minutes on an unspecified date, feeling foggy, like he had "smoked weed" but has not and dizziness. Patient reported as what to do about his side effects, thinks they are from a bad dose of the vaccine. Reported dizziness, and feeling foggy, like he had smoked weed but has not and possibly getting a bad dose of the Pfizer BioNTech Covid-19 vaccine because he saw the person at (withheld) pull it out of a box, and he thought it was supposed to come from the freezer. Knows it shouldn't be used after 6 hours, should be at room temperature for 30 minutes, and when he asked the provider about it, he was not happy with her answer. He wants to know what to do if he got a bad vaccine. Events were considered as non-serious. Outcome of all events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1534078
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: myocarditis; This is a spontaneous report from a contactable nurse reported for a patient via a Pfizer company representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on an unspecified date (batch/lot number and expiry date unknown) as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse reported "Verbatim question: for the covid vaccine, 12 and up, they encountered myocarditis. Can you please send/call her about this. She's a pediatrician. She would like more info.". The outcome of the event was unknown. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information and known drug profile, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and the reported event myocarditis. 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: 1534079
Sex: M
Age:
State: CA

Vax Date: 04/13/2021
Onset Date: 04/01/2021
Rec V Date: 08/07/2021
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: pt has been having dizziness since the first shop; The frequency and severity has gradually gotten worse, now daily, even when he wakes up; there's severe nausea at 8-9am; This is a spontaneous report from a contactable physician. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm right on 13Apr2021 16:15 (Lot Number: ER8731) as dose number unknown, single (at the age of 71 years old) for COVID-19 immunization. The patient's medical history included peptic ulcer disease, penetrating atherosclerotic ulcer of aorta, hiatal hernia, colon polyp, allergic rhinitis and conjunctivitis, long covid, cubital tunnel syndrome, tachycardia, elevated blood pressure, oxygen desaturation, pollen allergy and COVID; all from an unknown date. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included atorvastatin; lisinopril; famotidine; fluticasone nasal spray; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); all were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On unspecified date in Apr2021, reported event that pt has been having dizziness since the first shop. The frequency and severity has gradually gotten worse, now daily, even when he wakes up. There's severe nausea at 8-9am and he would need to sit down for an hour before it gets better. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on May2021 (Covid test post vaccination via nasal swab: Negative on May2021). No treatment given for adverse event (AE). The outcome of the events was not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Dizziness and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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: ATORVASTATIN; LISINOPRIL; FAMOTIDINE; FLUTICASONE; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1534080
Sex: F
Age:
State: IL

Vax Date: 03/30/2021
Onset Date: 03/31/2021
Rec V Date: 08/07/2021
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: starting the day after 2nd shot I had nosebleeds on and off all day and night for 10 days.; This is a spontaneous report from a contactable consumer (patient herself). A 67-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection. Lot Number: ER8732) via an unspecified route of administration, administered in Arm Left on 30Mar2021 08:30 as dose 2, single (at the age of 67-years-old) as dose 2, single for COVID-19 immunization. Medical history included allergic to asprin sulfa barium and cancer. Concomitant medications included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection. Lot Number EN6202) via an unspecified route of administration, administered in Arm Left on 09Mar2021 08:30 as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior the vaccination patient did not diagnosed with COVID-19. The patient experienced starting the day after second shot she had nosebleeds on and off all day and night for 10 days on 31Mar2021 06:00. The adverse event result in Emergency room visits and doctor or other healthcare professional office/clinic visit. Therapeutic measures cauterized and given afrin spray were taken as a result of nosebleeds. Since the vaccination patient did not diagnosed with COVID-19. The outcome of the event reported as unknown. No follow-up attempts are possible. No further information is expected

Other Meds: LIPITOR

Current Illness:

ID: 1534081
Sex: F
Age:
State: MD

Vax Date: 07/15/2021
Onset Date: 07/18/2021
Rec V Date: 08/07/2021
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: Diarrhea; Nausea; Vomiting within 72 hours of the shot; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 15Jul2021 14:15 (at the age of 43 years) (Batch/Lot Number: FA6780) as a single dose for COVID-19 immunization. Medical history included hypertension. Patient is not pregnant at the time of vaccination. Concomitant medications included losartan; cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC); and omeprazole magnesium (PRILOSEC). On 18Jul2021 14:00 , the patient experienced diarrhea with outcome of recovered with sequelae and nausea and vomiting within 72 hours of the shot with outcome of recovered in Jul2021. Nausea and vomiting lasted around 18 hours. Diarrhea continued but is not as frequent as onset. No treatment was received for the adverse events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Follow-up attempts are completed. No further information is expected.

Other Meds: LOSARTAN; ZYRTEC; PRILOSEC

Current Illness:

ID: 1534082
Sex: F
Age:
State: CO

Vax Date: 07/13/2021
Onset Date: 07/16/2021
Rec V Date: 08/07/2021
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: small rash on back of right thigh. similar to psoriasis; small rash on back of right thigh. similar to psoriasis; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Ew0183), via an unspecified route of administration, administered in right arm on 13Jul2021 16:45 as single dose for COVID-19 immunization. The patient's medical history included hypothyroidism. The patient had no known allergies. The patient's concomitant medications included estrogens conjugated (PREMARIN) and levothyroxine sodium (LEVOTHYROXIN). Facility where the most recent COVID-19 vaccine was administered was other. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced small rash on back of right thigh, similar to psoriasis on 16Jul2021 at 12:00. No treatment was received for the event. 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 not recovered. The events was reported as non-serious. Follow-up attempts are completed. No further information is expected.

Other Meds: PREMARIN; LEVOTHYROXIN

Current Illness:

ID: 1534083
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: Pharyngeal swelling

Symptoms: She had the best two weeks she has had in the last 10 years; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age and gender received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot numbers and expiry dates were not reported), via unspecified routes of administration on unspecified dates at single doses for COVID-19 immunization. Medical history included ongoing trouble hearing and Dercums. Concomitant medication was not reported. The patient reported that she had a rare autoimmune disease called Dercums which affected all the systems. She was told by the CDC that it was safe to take the Pfizer COVID shot with her disease. She has had both COVID shots and everything went perfect, her reaction to the shot was amazing. She had the best two weeks she has had in the last 10 years, did not know why or how. Everything worked, all the broken parts worked. Every week, someone with Dercum would also inform her that they felt so good after the Pfizer COVID vaccine. The outcome of the event was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness: Dercum's disease (She has a rare autoimmune disease called Dercums); Hearing disability

ID: 1534084
Sex: M
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: fainting sensation; disoriented; haziness in vision; anxiety; claustrophobia; light-headedness; headaches; cloudiness; cold; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a male patient (colleague's brother). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced fainting sensation, disoriented, haziness in vision, anxiety, claustrophobia, light-headedness, headaches, cloudiness, cold. In line with this, reporter would like to know if this side effects were reported and if it will go away. Outcome of all the events was not resolved. Follow-up (29Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100951344 Same reporter/ drug/ AE, different patient

Other Meds:

Current Illness:

ID: 1534085
Sex: F
Age:
State:

Vax Date: 07/24/2021
Onset Date: 07/01/2021
Rec V Date: 08/07/2021
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: Nauseous; This is a spontaneous report from a contactable consumer (reported for herself). A female patient of an unspecified age received first dose of BNT162B2 (Solution for injection, Lot number: unknown) via an unspecified route of administration on 24Jul2021, as DOSE 1, SINGLE for Covid-19 immunization. Medical history and concomitant medications were not provided. It was stated that had she received first shot a day prior to this report (reported as yesterday), her first vaccine and then she fell asleep and she woke up and she was hungry and tried to eat something. She felt nauseous, it made her nauseous and, what else. That's it, now she wanted to know if this was, because that's one of the symptoms that's on the papers that they gave. The patient stated, "was there something for her to worry about". The outcome of the event was unknown. The lot number for the vaccine was not provided and would be requested during follow up.

Other Meds:

Current Illness:

ID: 1534086
Sex: F
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: She has picked up a cold in the last few days; This is a spontaneous report from a contactable consumer (Patient) or other non-health care professional reported for herself. An unspecified age female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for Covid019 immunization. She got her Pfizer shot and is due for second one tomorrow. She has picked up a cold in the last few days. She thinks it is a cold. She wonders if they will give it to her tomorrow. She is not sure if she should show up and infect everyone. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up

Other Meds:

Current Illness:

ID: 1534087
Sex: F
Age:
State:

Vax Date: 05/29/2021
Onset Date: 06/17/2021
Rec V Date: 08/07/2021
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: . severely heavy menstrual bleeding; This is a spontaneous report from a non-contactable consumer (patient). A 33-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 29May2021 14:00 (Batch/lot number unknown), at age 33 years old, as dose number unknown, single, for COVID-19 immunisation, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. Relevant medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 17Jun2021, the patient experienced severely heavy menstrual bleeding. The patient stated that it was at least double of what she has ever bled for one cycle in her life. No treatment was taken for the event. The patient recovered from the event in on an unspecified date in Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1534088
Sex: F
Age:
State: NY

Vax Date: 04/01/2021
Onset Date: 05/01/2021
Rec V Date: 08/07/2021
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: Since being fully vaccinated in April 2021, I noticed my known condition (Vitiligo) spread a lot quicker within the past 3 months then prior months/years; his is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) (at the age of 36 years old) as dose 2, single for COVID-19 immunisation. Medical history included ongoing vitiligo. The patient's concomitant medications were 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. The patient received the first dose of BNT162B2 in left arm on COVID-19 immunization on 02Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01May2021, since being fully vaccinated in Apr2021 patient noticed known condition vitiligo spread a lot quicker within the past 3 months than prior months/years. No treatment for the events. The outcome of the event was not recovered. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness: Vitiligo

ID: 1534089
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: Started having an altered taste for some foods and drinks; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Historical Vaccine includes bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient experienced started having an altered taste for some foods and drinks on an unspecified date. It was reported that Patient had the Pfizer two shots vaccine for Covid-19 and patient had it for a while but about a month ago, started having an altered taste for some foods and drinks, patient haven't lost any smell or anything and patient had a Covid test recently just to see if there is anything going on with that but patient just can't figure out, patient talked to some doctors about why having an altered taste on some foods and drinks and I was just wondering, do you know of any cases or is there any information regarding people having that side effect. When probed if the result of Covid test that consumer had was negative, consumer stated, Correct. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome of event was Unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1534090
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: angular cheilitis; tongue inflammation; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (lot number and expiry date was not reported) as dose 1, single and dose 2 via an unspecified route of administration on 29Apr2021 (lot number and expiry date was not reported) as dose 2, single for COVID-19 immunization. Medical history included allergy to gluten on an unknown date. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient underwent an RT PCR nasal swab COVID test with an unknown result. It was reported that on an unknown date in 2021, two weeks plus one day after each vaccination, the patient developed angular cheilitis and tongue inflammation. After the first vaccination, the symptoms resolved within a few days. After the second vaccination, the symptoms wax and wane but have not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1534091
Sex: M
Age:
State: NJ

Vax Date: 07/22/2021
Onset Date: 07/25/2021
Rec V Date: 08/07/2021
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: I received the second shot on Thursday 2:30 pm. At 3:00 AM on Sunday, July 25, my heart started beating irregularly. My heart rate was extremely unstable and was fluctuating erratically from 60 to 130; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient) reported for himself that a 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0181), via an unspecified route of administration, administered in Arm Left on 22Jul2021 14:45 (Age at vaccination 50 years) as dose 2, single for covid-19 immunisation. Patient had no medical history. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number : EW0181), via an unknown route of administration on 01Jul2021 in left arm at 02:45PM (Age at vaccination 50 years) as dose 1, single for covid-19 immunisation. On 25Jul2021 at 3:00 am on sunday, the patient stated that heart started beating irregularly. heart rate was extremely unstable and was fluctuating erratically from 60 to 130 for around 5 hours. Patient received no treatment for event. The patient underwent lab tests and procedures which included heart rate: 60 to 130 bpm on 25Jul2021 heart started beating irregularly. No prolonged hospitalization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered at pharmacy or drug Store. Patient was not received any other medications within 2 weeks of vaccination. The clinical outcome of event was recovered on unspecified date in Jul2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1534092
Sex: M
Age:
State: MA

Vax Date: 05/24/2021
Onset Date: 05/28/2021
Rec V Date: 08/07/2021
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: The pain varies in location over my heart and chest.; chest pain; This is a spontaneous report from a contactable consumer (patient). A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24May2021 15:00 (Batch/Lot Number: EW0183) as dose 2, single for covid-19 immunisation at a hospital. Medical history included known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW1075) on 28Apr2021 15:30 in the left arm for Covid-19 immunization. The patient began having chest pain 3-4 days after his 2nd covid vaccine and this has continued since then. The pain occurs sometimes when resting but at all times when getting up and moving around. For example, he has chest pain when he walks down the stairs and even when he was standing up and washing the dishes. The pain sometimes lasts for 5 minutes but at other times it lasts for hours. The pain varies in location over his heart and chest. No SOB. He had to take an LOA from his job because of the continued chest pain which would last for hours while he was at work. The events started on 28May2021 and resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were not treated. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1534093
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: sweating; couldn't stand; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization and experienced activities of daily living impaired, fever and headache. After the second shot, the patient was sweating and couldn't stand for 4 days. The wife wanted to take the patient to the hospital because he looked like he was dying. Outcome of the events was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1534095
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
Hospital: Y

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: heart transplant rejection; leg swelling, like really bad scary swelling; trouble breathing; he could have gotten the Covid 19 virus; he could have gotten the Covid 19 virus; This is a spontaneous report from a contactable consumer (daughter-in-law). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 78-years-old) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 78-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included heart transplant and congestive heart failure. Concomitant medications included unspecified pills for the transplant. Historical vaccine included flu vaccine. The reporter (patient's daughter-in-law) heard from her husband that her father-in-law received the Covid 19 vaccine. Her father-in-law had a heart transplant over 10 years ago. Now he was having a heart transplant rejection and according to his doctor it was because of the Covid 19 vaccine. The patient was 78 years old when he received the Covid 19 vaccine. She thought he received the covid-19 vaccine early this year (2021) or late last year (2020). He was signed up to receive the covid-19 vaccine as soon as he could get it. She has not spoken to her father-in-law directly as he had been too ill. When probed for the Covid 19 vaccine information the she reported that she does not know the dates her father-in-law received the Covid 19 vaccines. She does not have the NDC/Lot/Expiry for either dose. She was sure it was a Pfizer product. When probed for medical history and concomitant medications she reported that before the heart transplant the patient had congestive heart failure. She does not know if he still has that or not. He also takes a thousand pills for the transplant but she does not have that information. She reported he received his heart transplant over 10 years ago from a 25-year-old female who had cytomegalovirus. He was taking medications for that also. She stated that her father-in-law was in the hospital for at least 4 days. He came home on a Tuesday. He spent the weekend in the hospital. It may have been last week or the week before. She was not sure. She clarified that the patient received his covid-19 vaccines at a mass vaccination site. She first learned about this information from her husband on last Friday, 23Jul2021. Her husband did not want her to tell anyone. She thought the patient had some leg swelling, like really bad, scary swelling. She does not know which leg was affected. She also thinks he had some trouble breathing. She thinks the doctor said he might be able to get the patient's medications under control, so the rejection is reversed. When probed about adverse events with any other vaccine she reported that she does not think he had any adverse events. He never complained to her about it, like the flu vaccine, no complaints. The reporter commented that she had not heard that the covid 19 vaccine could cause this nor have potential to cause this. She stated that the patient could have gotten the covid-19 virus, the heart rejection could have been caused by anything. Ten years after the heart transplant to be rejected, this was odd. The patient was hospitalized for heart transplant rejection and leg swelling, like really bad scary swelling for 4 days. Relevant tests were unknown. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1534096
Sex: M
Age:
State: PA

Vax Date: 07/25/2021
Onset Date: 07/01/2021
Rec V Date: 08/07/2021
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: he was bleeding; This is a spontaneous report from a contactable consumer. A 15-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 25Jul2021 (Batch/Lot Number: FA7484) as dose number unknown, single for covid-19 immunisation. Medical history included Crohn's disease. Concomitant medication included adalimumab (HUMIRA) taken for Crohn's disease, start and stop date were not reported. In Jul2021, it was reported that the patient received a vaccine of Pfizer and when he got the shot he bleed a lot, "a lot and we had to get tissues, we had to get gauze, he was bleeding". It was stated that it was unknown if that's a side effect. No treatment was received. The patient recovered from the event in Jul2021. Follow-up attempts are completed. No further information is expected.

Other Meds: HUMIRA

Current Illness:

ID: 1534097
Sex: F
Age:
State: IL

Vax Date: 07/07/2021
Onset Date: 07/01/2021
Rec V Date: 08/07/2021
Hospital: Y

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: I have got my first shot, I am supposed to get the second one and I am in the hospital because I have UTI (Urinary tract Infection); My arm was just little sore; It was just in the spot where I got the injection, just was red and sore; My arm was just little sore; It was just in the spot where I got the injection, just was red and sore; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 07Jul2021 (Batch/Lot number was not reported) (at the age of 73-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included open heart surgery; patient fell and got 2 titanium screws in her neck and three screws in her hip; she also had got venous stasis in the leg where the blood goes down but won't go back up. The patient had a whole list of concomitant medications (unspecified). It was reported that the patient was in the hospital. She got her first shot and she was supposed to get the second one, but she was in the hospital because she has UTI (Urinary tract Infection). So, she was just asking what to do as she does not want them to come to her home since she was not there. She asked whether she would just call when she gets out of the hospital. She confirmed that it was the first dose of Pfizer covid-19 vaccine. She got the first dose of the vaccine on 07Jul2021 and was supposed to get the second one on 28Jul2021, but she was still in the hospital. When probed about the side effects, she mentioned her arms was just little sore, but no she didn't have any side effects. She just wanted to know what she should do, if she should call when she gets out of the hospital to get her second shot. She commented that she wanted to get the second shot. She added that she read in the paper she was given about smell and taste and shortness of breath, and she read all that. She added no it did not swell up. It was just in the spot where she got the injection, just was red and sore but it went away right away. No side effects. The UTI, vaccination site pain and vaccination site erythema started in Jul2021. The outcome of urinary tract infection was unknown while vaccination site pain and vaccination site erythema was recovered in Jul2021. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1534098
Sex: M
Age:
State: CA

Vax Date: 03/01/2021
Onset Date: 06/10/2021
Rec V Date: 08/07/2021
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: Developed Atrial Flutter.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 01Mar2021 (Batch/Lot number was not reported) (at the age of 71-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient has not been diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Medical history included high blood pressure and acid stomach (waiting for consultation with cardiologist). The patient had no known allergies. Concomitant medications included omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and amlodipine besilate (NORVASC). On 10Jun2021 16:00, the patient developed atrial flutter. The patient never had this problem prior to covid-19 vaccine. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included echocardiogram: unknown results and heart monitor: unknown results. Therapeutic measures were taken as a result of the event which also includes echocardiogram and heart monitor. The patient had not yet recovered from the event. Information on the lot/batch number has been requested.

Other Meds: PRILOSEC [OMEPRAZOLE MAGNESIUM]; NORVASC

Current Illness:

ID: 1534099
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: Blurred vision; Tension/eye strain; Tension/eye strain; This is a spontaneous report from a contactable consumer (caregiver) received via a Regulatory Authority. An elderly, 70 to 80-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. After the 2nd dose of vaccine, the patient experienced blurred vision and tension/eye strain on an unspecified date. The outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1534100
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: drug induced lupus; This is a spontaneous report from a non-contactable consumer (the patient) A 38-years-old female patient received bnt162b2 (BNT162B2) unknown dose number, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced drug induced lupus (medically significant) on an unspecified date with outcome of unknown. Course of the event. The patient started experiencing lupus-like symptoms within weeks of taking the Pfizer COVID-19 vaccine. Rheumatologist suggested it might be drug induced lupus and is running more tests No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1534101
Sex: M
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/07/2021
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: headaches; he was dizzy; This is a spontaneous report from a non-contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID--19 VACCINE, Lot number was not reported), via an unspecified route of administration on Jan2021 as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got Pfizer-BioNTech Covid-19 vaccine in Jan2021. He haven't had any problems, until about 2 months ago (2021). The patient started having headaches and he was dizzy. He has had an MRI, EEG, wore a heart monitor, and a carotid artery check and they can't find anything wrong. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1534102
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: passed out several times and vomits; passed out several times and vomits; This is a spontaneous report from a non-contactable consumer. This consumer reported similar event for two patients. This the second of two reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) dose number was unknown, single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that their neighbor's boyfriend (patient) had passed out several times and vomits. The reporter asked if there was a clinical trial to study these side effects. Outcome of the 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: Linked Report(s) : US-PFIZER INC-202100956275 Same reporter, same drug and event, different patient

Other Meds:

Current Illness:

ID: 1534103
Sex: M
Age:
State: TX

Vax Date: 02/01/2021
Onset Date: 07/15/2021
Rec V Date: 08/07/2021
Hospital: Y

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: Unknown, was given for hypoxia twice a day; Caller says that the patient was diagnosed with ARDs; Shortness of breath; COVID-19 PCR test positive; COVID-19 PCR test positive; This is a spontaneous report from a contactable other hcp. A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on Feb2021 as dose 2, single for covid-19 immunisation. Medical history included hypertension, diabetes, coronary artery disease, CABG, hyperlipidaemia, high cholesterol. Concomitant medications included pravastatin (PRAVASTATIN) taken for blood cholesterol increased, start and stop date were not reported; metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported; carvedilol (CARVEDILOL) taken for hypertension, start and stop date were not reported. The patient previously took bnt162b2 dose 1 on Jan2021 for covid-19 immunization. The patient experienced covid-19 pcr test positive on 15Jul2021, shortness of breath on 17Jul2021, unknown, was given for hypoxia twice a day on an unspecified date, caller says that the patient was diagnosed with ards on an unspecified date with outcome of unknown. The patient was hospitalized for shortness of breath, unknown, was given for hypoxia twice a day, caller says that the patient was diagnosed with ards from 17Jul2021 to an unknown date. Patient stated, this patient was hospitalized, Seriousness: Medically significant. He says that the patient had tested positive 15Jul as an outpatient, then came to the hospital 17Jul2021 and was admitted, and then was an ICU transfer on 24Jul2021 when he was admitted his needs for oxygen increased, so they transferred him Med-Surg to the ICU 24Jul2021. patient was diagnosed with ARDs, his PF ratio was 94. Caller denies that patient had any cardiovascular, gastrointestinal, vascular, renal, cerebrovascular, haematological including no DIC no thrombocytopenia. Reporter denies patient had any dermatological or neurological systems affected. This patient had gotten worse since he was admitted but had stable since transfer to the ICU. Patient had symptomatic COVID after receiving both doses of Pfizer COVID-19 vaccine. Caller says he works in the ICU and they have three patients that were just admitted with COVID after having the Pfizer COVID-19 vaccine. He says there could be waning of immunity and he wanted to get a third dose. He says that they haven't tested their antibodies, and all but one of those patients are over 65 and have multiple comorbidities. He says one of those patients was 49 and had an increased BMI, which he wants to say it was a BMI of 45. He says that patient was an undiagnosed diabetic when they came into the hospital, with an A1C 6.5 which was right there on the threshold. Caller says that one of the patients was 79. Caller is only able to complete most of a report for the first patient who is 65 before he had to end the call. NDC/LOT/EXP and dates given for Pfizer COVID-19 vaccinations of his patients is unknown. Further details in additional context. The patient underwent lab tests and procedures which included angiogram was extensive bilateral ground glass opacities but no pulmonary embolism, blood creatinine was normal, fibrin d dimer was 4.4, fraction of inspired oxygen was 100%, glomerular filtration rate was normal, haemoglobin was 14 or 16, oxygen saturation was 96 % , pao2/fio2 ratio was 94, platelet count was greater than 200, respiratory rate was 30 breaths/minute, sars-cov-2 test positive: positive on 15Jul2021 , urine analysis was unkown result(they were clean with no ketones, leucoesterase, or nitrites on that), white blood cell count was 12.6, x-ray was multifocal opacities. Patient received treatment of Dexamethasone 10mg IV the patient was started on high dose steroids, 10mg of Dexamethasone IV, NDC/LOT/EXP: Unknown, was given for hypoxia twice a day for 5 days, then they will taper it for 5 days after that to 10mg daily IV. Patient received Remdesivir, NDC/LOT/EXP: Unknown, for the indication of active COVID infection. patient received 5 doses of this. Dose/Strength: Unknown, the normal dosage, since the infectious disease doctor orders it, for 5 days IV, one dose daily. Convalescent plasma: Caller says that on 21Jul the patient was given one unit FFP or convalescent plasma, which they get theirs form the Blood Bank. Indication was Unknown, he was guessing that they thought he didn't have enough antibodies, and those tests are still pending. Azithromycin, NDC/LOT/EXP: Unknown, and Rocephin, NDC/LOT/EXP: Unknown, as antibiotics that were stopped after he didn't have Procalcitonin levels. He says that the Azithromycin was started 17Jul2021 when he was admitted, then the Rocephin started July 24Jul2021 with his ICU transfer. He says that the Azithromycin was stopped after 5 days, and they started Rocephin which they stopped yesterday once Procal came back negative. the dose for Azithromycin was 500mg IV once a day and the Rocephin was one gram IV daily. The outcome of event was unknown. Information about lot/batch number has been requested.; Sender's Comments: The possibility of COVID-19, drug ineffective, dyspnoea, hypoxia, and ARDS, being an intercurrent condition cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out. 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-202100957229 same reporter, different patient, same drug, similar events

Other Meds: PRAVASTATIN; METFORMIN; CARVEDILOL

Current Illness:

ID: 1534104
Sex: F
Age:
State: WV

Vax Date: 03/01/2021
Onset Date: 07/13/2021
Rec V Date: 08/07/2021
Hospital: Y

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: transient ischemic attack; classic symptoms of a heart attack; she thinks it has effected her brain; radiating pain; sweating; could not get up and drive her car; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Mar2021 (72-years-old at the time of vaccination) (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included trigeminal nerve from an unknown date and unknown if ongoing. Concomitant medication included lamotrigine (LAMICTAL) : taking about 2 years taken for trigeminal nerve disorder, start and stop date were not reported. Patient received both doses of the vaccine on 01Mar2021 and 29Mar2021 and was hospitalized for heart attack symptoms(13Jul2021), but the patient was thinking it was not a heart attack. Patient Stated that she did not have any follow up appointments until 12Aug2021, caller stated she thinks it was more of a TIA, clarified trans ischemic attack, than an MI, so she was just checking . Patient Stated that the intense pain lasted 5-10 minutes, then had classic symptoms of a heart attack, clarified the radiating pain and sweating, lasted about 25-30 minutes, stated she was actually at a bible study when it happened, could not get up, could not get up and drive her car, by the end of the session went home and took an aspirin and a nap, at 6PM she went to MedExpress and they sent her to the hospital and she was admitted because of the symptoms she experienced. She was hospitalized for 3 days (13Jul2021 to 15Jul2021) with classic symptoms of a heart attack after the vaccines, but it was not panning out. She had not completely recovered, she thought it had affected her brain, took medication for trigeminal nerve problem, wondering if it could had disrupted that somehow. Stated she did not have any follow up appointments until 12Aug2021, caller stated she thinks it was more of a TIA, clarified trans ischemic attack, than an MI, so she was just checking. The reported seriousness of the event was hospitalization. The clinical outcome of the event transient ischemic attack,classic symptoms of a heart attack was not recovered, remaining all other events was unknown at the time of report. Information about lot/batch number has been requested.

Other Meds: LAMICTAL

Current Illness:

ID: 1534105
Sex: M
Age:
State: KS

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: now both legs are acting like I have peripheral neuropathy; I got the second shot almost 8 weeks later; having a hard time just walking; very painful; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old male patient received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on 2021 as dose 2, single (Age at Vaccination:70) for covid-19 immunisation. He received bnt162b2 (BNT162B2, Batch/Lot number: EW0176) via an unspecified route of administration, administered in right arm on 3May2021 at 10:00 AM as dose 1 single, for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing if covid prior vaccination: Yes, drug hypersensitivity from an unknown date and unknown if ongoing known allergies as Penicillin. Concomitant medication included finasteride (5mg daily) and metoprolol (25mg daily). Prior to vaccination, patient was diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 2021, The patient reported now his both legs were acting like i had peripheral neuropathy, got the second shot almost 8 weeks late, had a hard time just walking, very painful. After received the first shot, On 06May2021 at 01:00AM he started had a pain in my right calf and hamstring muscle. Like a pulled muscle. He had not been doing any heavy exercise other than walking. It was hard to walk because his right leg felt heavy. He got second shot almost 8 weeks later and now both legs was acting like he had peripheral Neuropathy. He was having a hard time just walking and it was very painful. He received treatment for the adverse event (testing pending). The outcome of the events were not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: FINASTERIDE; METOPROLOL

Current Illness:

ID: 1534106
Sex: M
Age:
State: ME

Vax Date: 03/13/2021
Onset Date:
Rec V Date: 08/07/2021
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: exertional shortness of breath; This is a spontaneous report from a contactable physician. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on 13Mar2021 (batch/lot number and expiry date unknown) at 64 years of age as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no other provoking risk factors and no personal or family history of VTE. The physician informed that after 1st vaccine, the patient experienced 2 days of significant exertional shortness of breath, then fully resolved. The event was reported serious (medically significant). The outcome of the event was recovered. The physician informed that the patient provided information regarding the reported adverse event with the use of the product. The physician did consider the Pfizer product had a causal effect to the adverse event. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect product BNT162B2 to the development of events exertinoal dyspnoea cannot be totally 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: 1534107
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: vaccine only serves half despite having the two doses, it gave me covid; vaccine only serves half despite having the two doses, it gave me covid; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (Patient) reported that a patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACUBE, Solution for injection), dose 2 and dose 1, both via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported vaccine only served half despite having the two doses, it gave covid and patient was screwed at home. The outcome of events was unknown. Information about lot/batch has been requested.

Other Meds:

Current Illness:

ID: 1534108
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: Thyroiditis subacute; This is a spontaneous report from a contactable consumer. This case belong patient 27. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced subacute thyroiditis on unspecified date. Calculated Time-to-onset (TTO): 0 days. It was reported that 29 reports of SAT (Agency preferred term (PT): thyroiditis subacute) following immunization with the novel COVID-19 vaccines. Furthermore, Agency comprised 50 cases reporting the PT autoimmune thyroiditis and another 50 cases reporting the PT thyroiditis following COVID-19 vaccination up to 8 June 2021. In 30 of the 50 cases reporting the PT autoimmune thyroiditis patients were described to suffer underlying Hashimoto's thyroiditis flaring up after the vaccination. The following analysis will focus on the cases reporting the Agency PT thyroiditis subacute as it was the only PT found to be disproportionately reported. In-depth analysis of the other mentioned PTs can be made available on demand. Cases reporting SAT were sent from nine countries. Countries contributing most reports were the (Withheld) (n=9), (Withheld) (n=6), and (Withheld) (n=4). Eighteen (62%) of the 29 reports were for the Pfizer/BioNTech mRNA vaccine, five for the Moderna mRNA vaccine, and six for the AstraZeneca adenovirus vector-based vaccine. Cases were mostly classified as non-serious (62%). In the 11 serious cases, two reported caused or prolonged hospitalization and the other nine medically important conditions as the seriousness criteria. Information on the dose number was available in 19 cases. In 11 cases the SAT occurred after administration of the first dose and in nine cases after the second dose. Time-to-onset (TTO) was observed to be in median three days after the second dose (ranging from 0 to 60 days) compared to a median TTO of six days after the first dose (ranging from 0 to 26 days). In one case (case 8), reporting the SAT onset after the second dose, it was mentioned that the patient experienced SAT already after the first dose and that symptoms recurred with the second (positive rechallenge). TTO in this case was reported as one day after vaccination with the second dose. Furthermore, this patient seemed to have an underlying thyroid disorder. It was reported that the symptoms of SAT resolved when she stopped her ''thyroid medication'' Since it was not specified what kind of medication the patient was taking, it is not possible to conclude whether it was underlying hyper- or hypothyroidism. Patients experiencing SAT following vaccination were mainly female (n=24; 83%) and five patients were male (17%). Patients' age was reported in 28 cases resulting in a median age of 45 years (range 18 to 67 years). The most frequently co-reported terms were pyrexia (n=7), lymphadenopathy and neck pain (each n=4), and blood TSH decreased, headache, hyperthyroidism, iodine uptake decreased, tachycardia, and thyroxine free decreased (each n=3). The radioactive iodine uptake (RAIU) test is a reliable test to differentiate between causes of hyperthyroidism. Low uptake suggests thyroiditis and high uptake suggests Grave's disease6. In the current case series, RAIU was performed in three cases confirming the diagnosis of SAT (cases 5, 23, and 26). In five reports (17%) cardiac reactions, such as tachycardia and palpitations, and in three cases (10%) hyperthyroidism were co-reported. Another eight cases contained non-specific reaction terms, such as pyrexia (n=7), neck pain (n=4), headache (n=3), and arthralgia (n=2). Information about the outcome was available in 22 cases. The outcome was reported as 'not recovered' at the time of reporting in 12 cases (41%), in eight cases it was reported as 'recovered' and in the remaining two cases the outcome was unknown. In seven cases (24%) patients reportedly received pharmacotherapy. In six of the cases corticosteroids (prednisone or dexamethasone) were used to treat SAT and in the remaining case the patient was planned to start antibiotic therapy. Information about the outcome was available in five of these cases. In two cases the patients were reported to have recovered, in one case the patient was recovering at the time of reporting and in the remaining two cases the outcome was reported as not recovered at the time of reporting, but in one of those cases (case 16) the patient was reported to respond to prednisone treatment. Except for case 8, a second patient (case 2) was reported to have an underlying thyroid disorder (autoimmune thyroiditis). Furthermore, the patient in case 13 was reported to have complained about a swelling at the right side of her neck with pain radiating to the right ear for one month prior to vaccination. She was furthermore reported to have underlying normocytic anemia. However, an SAT was suspected and successfully treated with NSAIDs and corticosteroids. In a third case (case 23) the patient was found to have had a past COVID-19 infection (diagnosed via an antibody test) but an acute infection was excluded via antigen testing. Seriousness criteria reported as intervention/medically important, hospitalization required and hospitalization prolonged. The outcome of event was not recovered at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1534109
Sex: F
Age:
State: AL

Vax Date: 07/27/2021
Onset Date: 07/27/2021
Rec V Date: 08/07/2021
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: When she scratches the rash, it results to bleeding; Hives (not in patches but randomly all over leg and arm)/Rash and hives all over; Itching; Rash; This is a spontaneous report received from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A 44-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- ER8729) via an unspecified route of administration in right arm on 27Jul2021 14:30 as dose 1, single (at the age of 44-years-old) for COVID-19 immunization. Vaccination facility type was reported as Clinic. The COVID-19 vaccine was administered to patient in military facility. Patient medical history included ongoing type 2 diabetes mellitus and ongoing hypothyroidism both of which were diagnosed 5 years ago. The concomitant medications included metformin, strength 1000 mg, taken for type 2 diabetes mellitus (Type II Diabetes) at a dose and frequency of 1000 mg, 2x/day with a daily dosing of 2000 mg from an unspecified start date and ongoing. The patient experienced when she scratched the rash, it resulted to bleeding, hives, itching and rash on 27Jul2021 19:00/20:00. Event onset dates for rash and hives all over was 27Jul2021. The event seriousness was reported to be unspecified. She clarified it was the COVID Vaccine. She stated was wondering if there was anything reported about a rash, hives all over. She got the shot yesterday. She got the shot about 14:30. The rash and hives started yesterday evening. By 19:00/20:00, patient legs were itching like rash and hives and it gradually went up to her knees and back of her legs. The rash and hives were like random spots. Then last night it started moving on her arms. Patient stated that she was taking Benadryl to keep from scratching skin off. She confirmed that she took her first dose of vaccine. While attempting to capture details, caller started speaking to someone in the background and difficult to hear/understand conversation with individual in background. Patient then came back to line and stated that her youngest son was mentioning about his own itching issue after receiving the COVID vaccine. She commented her vaccination card has the lot details, but the other ones do not. The adverse events did not result in physician or emergency room visit. Therapeutic measures were taken as a result of when she scratches the rash it results to bleeding, hives and itching. The outcome of the events was not recovered. Follow up (28Jul2021): This is a follow up spontaneous report received from a contactable consumer or other non-HCP (patient herself) and included event onset date details, unspecified reporter seriousness, adverse event details, confirmation on her vaccine dose number, information that the COVID-19 vaccine was administered at a military facility, prior vaccination details and details that the adverse events did not result in physician office or emergency room visit as was merged and processed with the initial narrative.

Other Meds: METFORMIN

Current Illness: Hypothyroidism (Other Conditions: Diagnosed 5 years ago); Type II diabetes mellitus (Verbatim: Type II Diabetes Other Conditions: Diagnosed 5 years ago)

ID: 1534110
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 08/07/2021
Hospital: Y

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: Postural orthostatic tachycardia syndrome; kept passing out; Constipation; Blurred vision; loss of words; in a wheelchair; Memory loss; Slurred speech; major fatigue; Headache; Fever chills; extreme dizziness; This is a spontaneous report from a contactable consumer (patient's mother-in-law). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 2 via an unspecified route of administration on an unspecified date in 2021 as single dose for covid-19 immunization (at the age of 39-year-old). The patient medical history was not reported. The patient's concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 via an unspecified route of administration on an unspecified date for covid-19 immunization (at the age of 39-year-old). The patient hospitalized for postural orthostatic tachycardia syndrome for 7 days between 24May2021 to 28May2021, kept passing out from May2021 to Jun2021. On an unspecified date in May2021, the patient experienced in a wheelchair and loss of words. He started to have memory loss and slurred speech around the same time of 24May2021 to 28May2021. Her son in law started wearing a helmet when he was released from the hospital. He also started using a wheelchair at that time. He was very weak and dizzy. In order to avoid accidents he was given a prescription for a wheelchair. Her son in law was perfectly healthy prior to this. He also had fever and chills like everyone does. Her son in law had a battery of test at the hospital to rule out any other possible cause. Results are unavailable at this time. Her daughter had the vaccine at the same time and was fine. On an unspecified date in 2021, the patient experienced extreme dizziness, major fatigue, headache, fever chills. On an unspecified date, blurred vision and constipation. The outcome of all the events was not recovered.

Other Meds:

Current Illness:

ID: 1534111
Sex: M
Age:
State: MD

Vax Date: 02/24/2021
Onset Date: 04/01/2021
Rec V Date: 08/07/2021
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: continual reduction in platelets.; This is a spontaneous report from a contactable consumer (Patient's niece). This consumer reported for a 76-Year-old-male (Patient) that. A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: el9264), dose 1 intramuscular, administered in Arm Right on 29Jan2021 as (at the age of 76-years) DOSE 1, SINGLE, dose 2 intramuscular, administered in Arm Right on 24Feb2021 (Lot Number: en6198) as (at the age of 76-years-old) DOSE 2, SINGLE for covid-19 immunisation. Medical history included, immune thrombocytopenia from an unknown date and unknown if ongoing (verbatim: Idiopathic thombocytopenia purpura), prostatomegaly from an unknown date and unknown if ongoing (verbatim: enlarged prostate). Concomitant medication (received within 2 weeks of vaccination) included finasteride 5 MG, and plantago ovata (METAMUCIL [PLANTAGO OVATA]) all wares taken for an unspecified indication, start and stop date were not reported. The patient previously took tetracycline and experienced drug hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not test for COVID-19 since the vaccination. The patient experienced continual reduction in platelets on 01Apr2021. As a result of event patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care . Patient received Prednisone 60 MG as treatment for event. The patient underwent lab tests and procedures which included platelet count: decreased on 01Apr2021 Continual reduction in platelets. The outcome of event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: FINASTERIDE; METAMUCIL [PLANTAGO OVATA]

Current Illness:

ID: 1534112
Sex: F
Age:
State: AL

Vax Date: 04/22/2021
Onset Date:
Rec V Date: 08/07/2021
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: My menstrual cycle has been off since I got my first vaccine; This is a spontaneous report from a contactable consumer reported for herself. A 22-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 22Apr2021 08:00 AM (at the age of 22-years-old), as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history, concomitant or other medications in two weeks, other vaccine in four weeks included none. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced her menstrual cycle had been off since she got first vaccine. It was stated that her menstrual cycle has been off since she got first vaccine, but she didn't really notice it until after her second. There were 50 days between her cycle in May and June, and then another 35 days between June and July. Her cycle has been notably worse as well, heavier bleeding and cramping as well as getting migraines frequently when on her period. Serious criteria included none and the event was not serious. No treatment received for the event. Clinical outcome of the event was not recovered. Information on lot/batch number was not provided and would be requested during follow up.

Other Meds:

Current Illness:

ID: 1534113
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: Took the first shot, her throat closed up; This is a spontaneous report from a contactable consumer (husband). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took the first shot, her throat closed up on an unspecified date. Patient took 2 Benadryl, and it went away. Patient was recommended to go to the ER, she didn't want to go, went home and was recommended take 2 Benadryl, and that took care of her problem. Patient also took 2 Benadryl before with the second, and that eliminated her throat closing down. Reporter did not want to go through a report for patient, as patient was ok at the time of this report, it was no problem, but he thought to mention, as it might be a problem with the batch, she was ok and had no repercussions. Therapeutic measures were taken as a result of the event. Reason for no lot number of Pfizer COVID vaccine stated as caller unwilling to complete the report. Outcome for the event was recovered on an unspecified date. Lot number for the vaccine (BNT162B2), was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1534114
Sex: F
Age:
State: IN

Vax Date: 07/16/2021
Onset Date:
Rec V Date: 08/07/2021
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: vaccine she received was not stored at the proper temperature; Muscle spasms; Her arm is still sore; There is a bruise were the shot was administered; This is a spontaneous report from a contactable consumer or other non hcp. A 33-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EW0176)), dose 1 via an unspecified route of administration, administered in the left arm on 16Jul2021 as dose 1, single for COVID-19 immunisation. The patient's medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Allergic reaction to pain medication that starts with M. she had no pre-existing conditions. She never had an allergic reaction to anything other than Tramadol and another pain medication that starts with an M. No other issues. The allergic reaction to Tramadol and the pain medication that started with M was more than 5 years ago. Caller doesn't have NDC, lot, or expiry to provide for Tramadol or the pain medication that starts with M. With the flu shot she got sick. That lasted for 3 days. She got stuffy, runny nose. That was about 10 years ago. She doesn't have NDC, lot, and expiry for the flu shot. The patient's concomitant medications were not reported. The patient previously took tramadol and experienced drug hypersensitivity, flu vaccine vii and experienced illness, flu vaccine vii for nasal congestion, flu vaccine vii for rhinorrhoea. On an unknown date in 2021, the patient experienced vaccine she received was not stored at the proper temperature (expired product administered), muscle spasms, her arm was still sore, there was a bruise where the shot was administered. Received first dose of COVID vaccine two weeks ago. Pharmacy called her and said that the vaccine she received was not stored at the proper temperature and she needs to start the vaccine series over. Are there any possible side effects since it wasn't store properly. She ad muscle spasms since she was vaccinated on left arm. The vaccine was given in the left arm and that was the arm she was having muscle spasms in. The muscle spasms started 24 to 48 hours later. It was every day, but it was not continuous. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not go to it comes in spurts. The patient did not go to emergency room. She just had one not long ago, about 2 minutes ago. She could feel it and stretched her arm and rotated it. Her arm was still sore. There was a bruise where the shot was administered. The new variant was the number one reason. Caller had a minor child in the home who was going back into school face to face. There are a lot of people against it, and she got it to help protect everyone else. It would be better than not having it. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1534115
Sex: M
Age:
State: TN

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 08/07/2021
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: that he had his two vaccine shots after he tested positive for COVID.; This is a spontaneous report from a contactable consumer or other non hcp. A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date of Mar2021 (at the age of 79-years-old), as DOSE 1, SINGLE; dose 2 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history included rheumatoid arthritis (Additional information for other conditions: Caller says he thinks this was diagnosed when he was 52 or 53 years), Blood pressure high (Additional information for other conditions: Caller says this was diagnosed when he was around 60. Caller says he has high blood pressure, he takes medication for this), hard of hearing, tired for three days, and had a little temperature (he had COVID he was real tired for three days, and had a little temperature), body temperature abnormal. Concomitant medication(s) included tofacitinib citrate (XELJANZ XR) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced that he had his two vaccine shots after he tested positive for covid. The patient underwent lab tests and procedures which included blood test: unknown result (Caller says his rheumatologist has him do blood tests every 3 months, but he doesnt think any of those results would be relevant), body temperature: little (had a little temperature) on an unspecified date, sars-cov-2 test: positive (He says that he tested positive for COVID-19 06Feb, and after his positive test they told him to stay in 14 days, so that is what he did, and he had his shots.) on 06Feb2021 and again sars-cov-2 test: positive on an unspecified date. Outcome of the event was not recovered. Additional context: Warm transfer from (Name-withheld) CEP 2591 of Patient taking Xeljanz XR 11mg tablets. Agent reports that the patient was off his medication for two and a half weeks after he got the COVID virus and his doctor told him to be off of the medication, But he is doing better now, and is back on his medication. Agent reports that she has already assisted the patient with his assistance program enrollment. Caller says he is hard of hearing, caller doesn't clarify this statement. Xeljanz XR 11mg NDC/LOT/EXP: Caller says he doesnt have his medication with him, it is in the house and he is in his office. Caller says he started taking Xeljanz XR 11mg four year ago. He says he was off of it about 14 days to be exact, he was told he would be able to in 14 days. He says that he tested positive for COVID-19 06Feb, and after his positive test they told him to stay in 14 days, so that is what he did, and he had his shots. He says that the COVID test they did was to swab up his nose two times, so he is assuming he is ok. Caller clarifies that he had his two vaccine shots after he tested positive for COVID. He says he was off his Xeljanz XR 11mg medication for 14 days in Feb, Then started taking it again either the 20th or 21st. He says when he had COVID he was real tired for three days, and had a little temperature. He says he was told not to go outside that time until after 14 days, so he did what he needed to do, he had no restrictions. He says when he went back to the doctor, and they told him after 14 days he ought to be fine. Caller clarifies that he got his first covid-19 vaccination on the 06Mar or 07Mar, then the next dose on the 27Mar. Caller doesn't provide any further details about his unspecified Covid-19 vaccinations. Other medical conditions: Caller says he has high blood pressure, he takes medication for this. No further details provided about his high blood pressure medication. No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.

Other Meds: XELJANZ XR

Current Illness:

ID: 1534116
Sex: F
Age:
State: OK

Vax Date: 07/17/2021
Onset Date: 07/01/2021
Rec V Date: 08/07/2021
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: feel hot and cold sensations on face; feel hot and cold sensations on face; I can't use my right hand, my both of my legs, I could barely sit down; I thought I was dying; I break out in a sweat/breaking out with my sweat; I have a fever/thought I had a fever; I got the chills/shivered; have this stabbing pain in my left arm/have quickly pain all over hand/ arm hurt very bad; my right hand is defunked; I'm sick. I'm really really sick. Really sick.; I can't breathe/unable to breathe; coughing; I had that preliminary pain in my upper left shoulder; my left knee is locked; I have pain and tingling in my body; I have pain and tingling in my body/ there is needle pinching me; I'd breathe my diaphragm hurt.; This thing is screwing up our nervous system.; I can barely walk./walk like an 80 year old women; numbness; I can barely get out of bed/I'm laying in bed; pain at injection site; This is a spontaneous report from a contactable consumer reported for self. This 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 17Jul 2021 at the age of 37-year-old as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included ongoing some UTIs, Overweight. She believes she received either a placebo dose or a weakened dose as a result of "Pfizer's negligence". She experienced can't breathe in Jul2021, was sick. She was really really sick. Really sick in Jul2021. Here she was having all the symptoms of Covid unable to breathe in Jul2021, coughing in Jul2021. She took a blood test. It came out negative every time. She had that preliminary pain in her upper left shoulder in Jul2021, and she was like, ok well everybody goes through it. It stopped, she was fine, everything was great. Four days ago, she had this stabbing pain in her left arm. It starts from her left arm. She went to the ER. Tested negative. They did a nasal swab. If they tested blood, probably would have been positive for Covid because took the vaccine. But, do not have Covid. So, so anyway, four days ago she break out in a sweat. She had a fever on 25Jul2021. She broke out in a sweat (25Jul2021) and never- she thought she was dying (25Jul2021). She had never had a- she felt like had a fever, but when temperature was taken she didn't have a fever, she had a normal body temperature, right? And then she got the chills on 25Jul2021. She was laying in bed/ barely get out of bed in Jul2021 in withheld a very hot state. She had her heaters cranked up. Two years and this never happened to her - it finally happened. She put four blankets on top of herself and shivered and shivered and shivered and shivered and shivered. When she went to the ER, they checked her vitals; everything looked great. Her left knee is locked in Jul2021, she can barely sit on the toilet, her right arm. Her right hand was defunked in Jul2021 (Disability); it has no use anymore. She had to be put on Prednisone and it helps a little. She couldn't breathe because every time she'd breathe her diaphragm hurt in Jul2021. Um, these symptoms, having chills and fever but not registering a fever. This thing was screwing up our nervous system in Jul2021. She had pain and tingling in her body in Jul2021. She was a healthy 37 year old woman. Some numbness in Jul2021, she can barely walk n Jul2021. But she was disabled. She can't use her right hand. She didn't know if this is going to persist. And then her left leg has been stiff; She can't straighten it. The first two days her arm hurt very bad (18Jul2021) which she was told normal so she excepted ok. This is normal she had vaccine before fine, four days ago, this pain at injection site in Jul2021she had excruciating pain like somebody is stabbing arm with the injection site at left side but it was administered at right side. She went to ER (Further clarification unknown) , they can't find out what is wrong with her. She thought she had a fever, she was breaking out with sweat and when they check there was no fever. She walked like an 80-year-old women, had to quite other job because was so sick, can't work. This vaccine has destroyed life, she had healthy immune system. She went to ER room they were saying you are Covid, you got Covid saying. They took the swab and was negative, she didn't have Covid, didn't catch Covid, she had quickly pain all over hand, there is needle pinching her, she can feel hot and cold sensations on face. She can't use her right hand, her both of her legs, she could barely sit down. Outcome of the event right hand is defunked was recovering. Outcome of the event preliminary pain in her upper left shoulder was recovered in Jul2021. Outcome of other events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness: UTI

ID: 1534117
Sex: F
Age:
State: NY

Vax Date: 03/12/2021
Onset Date: 03/13/2021
Rec V Date: 08/07/2021
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: 4 days after the shot I also developed neuropathy around the left lesser occipital nerve and on top of my head, left side; The day after my second dose, I developed a debilitating migraine that lasted for 6 days. I've never experienced a migraine like this before--it didn't respond to any drugs. When the migraine subsided; I was left with a dull persistent headache; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 43-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6205) via an unspecified route of ad-ministration, administered in arm left on 12Mar2021 08:00 (at the age of 43-years-old) as dose 2, single for COVID-19 immunization. Medical history included sjogren's syndrome. The patient had no known allergies. Concomitant medications included Nortriptylene 40 mg, Magnesium 750 mg. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On 13Mar2021 at 04:00 PM, the day after her second dose, she developed a debilitating migraine that lasted for 6 days. She has never experienced a migraine like this before, it didn't respond to any drugs. When the migraine subsided, she was left with a dull persistent headache that hasn't yet resolved. This headache episodically blooms into migraines. 4 days after the shot she also developed neuropathy around the left lesser occipital nerve and on top of my head, left side and being treated with gabapentin, propranolol, triptans, and nerve injections at the headache clinic but the condition is still here. Therapeutic measures were taken as a result of the events which include multiple meds, nerve block injections, acupuncture. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.

Other Meds: NORTRIPTYLINE; MAGNESIUM

Current Illness:

ID: 1534118
Sex: F
Age:
State: TX

Vax Date: 03/25/2021
Onset Date: 07/28/2021
Rec V Date: 08/07/2021
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: COVID positive diagnosis 28Jul2021; COVID positive diagnosis 28Jul2021; This is a spontaneous report from a contactable consumer. A 62-years-old female consumer (patient) reported for herself. A 62-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection.), dose 1 via an unspecified route of administration, administered in left arm on 04Mar2021 at 12:00 (Lot number: unknown) as dose 1, single, dose 2 via an unspecified route of administration, administered in right arm on 25Mar2021 at 10:45 (Lot number: unknown) as dose 2, single for COVID-19 immunization (at the age of 62-years-old). Medical history included moderate to severe atopic dermatitis. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. Patient had no COVID-19 prior vaccination. Patient had no known allergies. Concomitant medication included acetylsalicylic acid (BAYER ASPIRIN) in two weeks. The patient experienced COVID-19 positive diagnosis on 28Jul2021. Adverse event start on 22Jul2021 at 01:45 PM. Seriousness criteria-results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect all reported as no. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on post vaccination on 28Jul2021. Adverse event resulted in, Doctor or other health care professional office/clinic visit. Adverse event treatment include Medrol dosepak. The outcome of the event COVID positive diagnosis 28Jul2021 (covid-19) was not recovered and unknown for another event. Information about lot/batch number cannot be obtained. Information on the lot/batch number has been requested.

Other Meds: BAYER ASPIRIN

Current Illness:

ID: 1534119
Sex: F
Age:
State: OR

Vax Date: 01/22/2021
Onset Date: 01/01/2021
Rec V Date: 08/07/2021
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: Thought I was DYING.; Gastrointestinal issues; Experience muscle weakness; Muscle pain; Cramping; Twitching; Weird neurological surges through my limbs; Shaking spasms through my body.; 1st dose on 22Jan2021 and 2nd dose on 22Jan2021; Heart attack; Pulmonary embolism.; I had an immediate "wave"of weirdness with increased heart rate; I had an immediate "wave"of weirdness with increased heart rate; A week later I had chest pains; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, administered in Left arm on 22Jan2021 09:00 at the age of 60-years-old as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in Left arm on 22Jan2021 at the age of 60-years-old as single dose covid-19 immunisation. Medical history included colitis, back surgeries and hysterectomy. Concomitant medications included atorvastatin, estradiol cream, multivitamins and ubidecarenone (COQ10) taken for an unspecified indication from unspecified date received in two weeks of vaccination. The patient previously took sodium sentathol and experienced allergy. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient has been tested for COVID-19 post vaccination. It was reported that after first dose patient had an immediate wave of weirdness with increased heart rate on an unspecified date in Jan2021. A week later, on an unspecified date in Jan2021, she had chest pains which urgent car decided to send me to the ER. They checked for a heart attack or pulmonary embolism. On an unspecified date in mid-may2021, she began to experience muscle weakness, which rapidly progressed to muscle pain, cramping, twitching and weird neurological surges through her limbs and shaking spasms through her body. patient thought she was dying. She had multiple tests run. Nerve conduction, bloodwork, CT scans, ultrasounds. All tests have come back normal. Still having bad symptoms. she was convinced that this is a side effect of the COVID vaccine. She has also been dealing with gastrointestinal issues on an unspecified date in May2021, but she does not believe they are related. She believes a lot of people are having these same issues. she still believes it is important to get the vaccine though for the sake of society. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The patient received treatment for adverse events. on adverse event treatment Anxiety meds, she stated that no one knew what to do. The patient underwent lab tests and procedures which included bloodwork which was normal on an unspecified date in May2021, CT scans on an unspecified date in may2021, which was normal , Nerve conduction was normal on and conducted on unspecified date in May2021, she had SARS-COV-2 IgG Antibody post vaccination with positive result on 15Jun2021, ultrasounds was normal on an unspecified date in May2021 and heart rate was increased heart rate on an unspecified date in Jan2021. The outcome of events, heart attack, pulmonary embolism and inappropriate schedule of vaccine administered was unknown while other events were not recovered.

Other Meds: ATORVASTATIN; ESTRADIOL; MULTIVITAMINS [VITAMINS NOS]; COQ10

Current Illness:

ID: 1534120
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: fast heart beat; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2 solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fast heart beat on an unspecified date. The patient underwent lab tests and procedures which included heart rate: fast on unspecified date. The historical vaccine include BNT162B2 (DOSE:1) for COVID-19 Immunization. Reported as I had a fast heart beat on the first dose and I had that reaction for two days after I had the vaccine. Now the other person that I know that person said that he has the same reaction but it was on the second dose and I wanted to let you know that person I don't think is going to report it. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1534122
Sex: F
Age:
State:

Vax Date: 07/28/2021
Onset Date: 07/01/2021
Rec V Date: 08/07/2021
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: lower back pain/dense pain; reported arm pain after receiving the Pfizer Covid 19 Vaccine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 28Jul2021 as dose number unknown, single for COVID-19 immunization. Medical history included kidney infection. Caller reported a previous kidney infection. Was started on Bactrim (sulfamethoxazole). The patient's concomitant medications were not reported. The patient previously took sulfamethoxazole. Other Products were not provided. The patient experienced kidney infection (medically significant) and lower back pain/dense pain on an unspecified date in Jul2021. It was reported that, patient received her Pfizer Covid 19 Vaccine on 28Jul2021. She was feeling fine. She now had lower back pain. Caller reported a previous kidney infection. Was started on Bactrim (sulfamethoxazole). Patient enquired if she should contact her HCP or if the symptom might be related to the vaccine. Patient enquired if it was okay to take the Bactrim (sulfamethoxazole). Caller reported arm pain after receiving the Pfizer Covid 19 Vaccine and asked what's the time span that side effects were reported. Report was not related to a study or programme. Patient reported that, she got the shot yesterday and was feeling fine and asked if this was something she should look out for or if she should contact her HCP and her lower back had a dense pain. Therapeutic measures were taken as a result of kidney infection. The outcome of the events was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up. Follow-up attempts completed. No further information is expected.

Other Meds:

Current Illness:

Date Died:

ID: 1534123
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: passed away; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date as single dose, and dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. As reported, caller was a patient who stated he and his wife received the Pfizer COVID vaccine, and were vaccinated in Jan2021 and Feb2021. Caller was inquiring about the antibody testing, as he and his wife had one done. Caller wanted to know why he and his wife tested negative for antibodies. Caller was concerned because his sister who had both the Pfizer COVID vaccine shots passed away and she showed not having any antibodies. The patient died on an unspecified date. An autopsy was not performed. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away

Other Meds:

Current Illness:

ID: 1534124
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: last time my left eye is all kind of red; This is a spontaneous report from a contactable consumer. This consumer (Patient) reported for self. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced last time my left eye is all kind of red on an unspecified date in 2021. It was reported that, patient got second Covid shot yesterday last time and patients left eye was all kind of red and so this morning patient woke up kind of crested, patient never had pinkeye before and did not know if it was pinkeye was it something might be having a shot patient would get. Patient just wanted to talk to someone if it was a side effect it was Saturday doctor's office was not open. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1534125
Sex: F
Age:
State: NJ

Vax Date: 03/12/2021
Onset Date: 07/01/2021
Rec V Date: 08/07/2021
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: Covid-19; Covid-19; Eye pain; Headache; Fatigue; Weakness; Sore throat; Stuffy nose; Cough; This is a spontaneous report from a contactable consumer (patient reported for herself). 26-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an intramuscular route of administration, administered in Arm Left on 19Feb2021 (at the age of 26-year-old) (Lot Number: EL9266) as DOSE 1, SINGLE and dose 2 via an intramuscular route of administration, administered in Arm Left on 12Mar2021 (at the age of 26-year-old) (Lot Number: EN6206) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Jul2021, the patient experienced Covid-19, Headache, Fatigue, Weakness, Sore throat, Stuffy nose, Cough, and Eye pain. On 29Jul2021, post vaccination, the patient underwent SARS-CoV- 2 rapid ag (Nasal Swab) test, which was positive for covid-19. Patient received treatment with Tylenol to treat the events. The outcome of all the events was not resolved at the time of this report.

Other Meds:

Current Illness:

ID: 1534126
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: Hyperthyroidism; Thyroiditis subacute; Inflammation; This is a spontaneous report from a Non-contactable consumer. The reporter had an overview of 29 cases reporting SAT (Subacute thyroiditis) after COVID-19 vaccination. This is one of the cases for a 42/M patient. A 42-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, formulation: solution for injection, Batch/Lot number were not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, formulation: solution for injection, Batch/Lot number were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date after dose 2, the patient experienced thyroiditis subacute, hyperthyroidism, and inflammation. The event hyperthyroidism was serious (medically significant). The Time-to-onset (TTO) was 1-month. It was reported that the patient had hyperinflammation and severe hyperthyroidism three weeks after vaccination (2nd dose) and was treated with prednisone. The patient underwent lab tests which included Ultrasound that showed nodules in the thyroid with dysregulated thyroid hormones, on an unspecified date. The patient received treatment for the events. The outcome of the events was unknown. Summary of the report: The reporter had an overview of about 29 patients (Between age of 18 and 67years) who had reported SAT (Subacute thyroiditis) after COVID-19 vaccination. Reporter stated that patients experiencing SAT following vaccination were mainly female (n=24; 83%) and five patients were male (17%). Patients' age was reported in 28 cases resulting in a median age of 45 years (range 18 to 67 years). By 08Jun2021 there were 29 ICSRs reporting SAT following the immunization with COVID-19 vaccines entered in VigiBase. Most of the reports contained Pfizer/BioNTech's and Moderna's mRNA-based vaccines as suspected. Statistically significant disproportionate reporting was observed for these two vaccines. Eleven reports (38%) were classified as serious and in seven cases (24%) pharmacotherapy of SAT symptoms was reported. In five reports cardiac reactions, such as tachycardia and palpitations, and in three reports hyperthyroidism were co-reported. Since SAT's symptomatology can be confused with other painful oropharyngeal conditions (e.g.: odontalgia) but carries the risk of thyrotoxicosis and therefore the possibility of related cardiac, hepatic, and neuromuscular conditions, patients and health care professionals should be sensitized to consider the possibility of SAT following vaccination with the novel COVID-19 vaccines. Introduction: Subacute thyroiditis (SAT) is an inflammatory disease of the thyroid caused by viral infections or autoimmune reactions. Its reported incidence was 12.1 cases/100,000 person years with a higher incidence in females than males (19.1 vs 4.1 cases/100,000 person years) between 1970 and 19971. However, no recent information about SATs incidence is available. Furthermore, SAT was observed to occur more commonly during young adulthood and in middle-aged patients2. Typical, but rather nonspecific symptoms include pain in the anterior neck and fever. Furthermore, hyperthyroidism-like symptoms, such as tachycardia, agitation, tremor, and hyperhidrosis can occur. Because of thyroid follicular cell destruction thyroglobulin is degraded leading to the uncontrolled liberation of triiodothyronine (T3) and thyroxine (T4). Due to increased levels of free T3 (FT3) and T4 (FT4) the release of thyroid-stimulating hormone (TSH) is reduced. These processes result in the clinical picture of hyperthyroidism carrying the risk for the development of thyrotoxicosis potentially increasing the occurrence of related cardiac, hepatic, or neuromuscular disorders3. Therapeutic options are the administration of non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief but in some cases corticosteroid treatment can be necessary4. SAT was added to Research Organization's list of COVID-19 adverse events of special interest (AESI) in Jan2021. It was observed that SAT occurred primarily as a post-infectious condition with a delayed onset of several weeks after an acute COVID-19 infection5. A safety signal for SAT following COVID-19 vaccination was observed via disproportionality analysis comparing the number of observed reports against the calculated number of expected reports.Disproportionate reporting was observed to be statistically significant for the two mRNA-based vaccines of Pfizer/BioNTech (observed n=18, expected n=3) resulting in a lower 95% limit of the Information Component measure for disproportionality (IC025) of 1.5 and Moderna (observed n=5, expected n=1, IC025 = 0.1). The expected value is based on the total number of reports on the covid-19 vaccines and the proportion of reports that relate to SAT in the VigiBase. Reports in VigiBase: Up to 08Jun2021, VigiBase, the WHO database of individual case safety reports (ICSRs), contained 29 reports of SAT (MedDRA preferred term (PT): thyroiditis subacute) following immunization with the novel COVID-19 vaccines. Furthermore, VigiBase comprised 50 cases reporting the PT autoimmune thyroiditis and another 50 cases reporting the PT thyroiditis following COVID-19 vaccination up to 08Jun2021. In 30 of the 50 cases reporting the PT autoimmune thyroiditis patients were described to suffer underlying Hashimoto's thyroiditis flaring up after the vaccination. The following analysis will focus on the cases reporting the MedDRA PT thyroiditis subacute as it was the only PT found to be disproportionately reported. In-depth analysis of the other mentioned PTs can be made available on demand. Cases reporting SAT were sent from a number of countries. Contributing most reports amounted to (n=9), (n=6), and (n=4). Eighteen (62%) of the 29 reports were for the Pfizer/BioNTech mRNA vaccine, five for the Moderna mRNA vaccine, and six for the AstraZeneca adenovirus vector-based vaccine. Cases were mostly classified as non-serious (62%). In the 11 serious cases, two reported caused or prolonged hospitalization and the other nine medically important conditions as the seriousness criteria. Information on the dose number was available in 19 cases. In 11 cases the SAT occurred after administration of the first dose and in nine cases after the second dose. Time-to-onset (TTO) was observed to be in median three days after the second dose (ranging from 0 to 60 days) compared to a median TTO of six days after the first dose (ranging from 0 to 26 days). In one case (case 8), reporting the SAT onset after the second dose, it was mentioned that the patient experienced SAT already after the first dose and that symptoms recurred with the second (positive rechallenge). TTO in this case was reported as one day after vaccination with the second dose. Furthermore, this patient seemed to have an underlying thyroid disorder. It was reported that the symptoms of SAT resolved when she stopped her "thyroid medication". Since it was not specified what kind of medication the patient was taking, it is not possible to conclude whether it was underlying hyper- or hypothyroidism. Patients experiencing SAT following vaccination were mainly female (n=24; 83%) and five patients were male (17%). Patients' age was reported in 28 cases resulting in a median age of 45 years (range 18 to 67 years). The most frequently co-reported terms were pyrexia (n=7), lymphadenopathy and neck pain (each n=4), and blood TSH decreased, headache, hyperthyroidism, iodine uptake decreased, tachycardia, and thyroxine free decreased (each n=3). The radioactive iodine uptake (RAIU) test is a reliable test to differentiate between causes of hyperthyroidism. Low uptake suggests thyroiditis and high uptake suggests Grave's disease6. Literature and labelling: SAT is not labelled as a potential adverse reaction in the three included vaccines' Summaries of Product Characteristics (SmPCs)7?9.

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Current Illness:

ID: 1534127
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
Hospital:

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: Thyroiditis subacute; Lymphadenopathy; Tachycardia; This is a spontaneous report from a non-contactable consumer. A 41-years-old female patient received first dose of bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 (at age of 41-years old) as dose1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced thyroiditis subacute, lymphadenopathy, tachycardia. It was reported that calculated time to onset (TTO) was 14 days. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974883

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Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm