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: 1522018
Sex: F
Age:
State:

Vax Date: 07/24/2021
Onset Date: 07/01/2021
Rec V Date: 08/03/2021
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: having burning pain in lymph nodes under her left arm; having burning pain in lymph nodes under her left arm that is getting worse; pain that radiated into her left leg / having burning pain in lymph nodes under her left arm; pain is so bad; This is a spontaneous report from a contactable consumer or other non hcp (parent) reported for her daughter (patient). A 30-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on 24Jul2021 as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The reporter reported the patient had left side pain that radiated into her left leg on Sunday but it subsided. Previous day she began having burning pain in lymph nodes under her left arm that is getting worse. She got the vaccine in her left arm. She fought getting the vaccine because she heard it causes fertility issues but finally decided to get it. She had to leave work because the pain was so bad. The reporter asked was this normal. Had it been reported before and how long would it last. The outcome of the events was reported as not resolved. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1522019
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 08/03/2021
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: contracted COVID-19; contracted COVID-19; This is a spontaneous report from a non-contactable consumer (patient). A 52-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on Mar2021 (end of March) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of 2021, patient contracted COVID-19. It had already been 4 months past her first dose, and she wanted to know if she can still take the second dose of the vaccine with this situation. Patient was concerned since one doctor told her that she should start the vaccination series all over again and the other doctor told her that it was okay to go ahead with the second dose. The outcome of both 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: 1522020
Sex: F
Age:
State:

Vax Date: 07/08/2021
Onset Date:
Rec V Date: 08/03/2021
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: have both now been diagnosed with COVID; have both now been diagnosed with COVID; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: was not reported; Expiration Date: was not reported), dose 1 via an unspecified route of administration on 08Jul2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced have both now been diagnosed with COVID-19 and feeling sick on an unspecified date. Caller stated both her and her son received their first dose of the Pfizer COVID-19 vaccine on 08Jul2021 and have both now been diagnosed with COVID-19. Caller was looking for information about when her and she son can get the second dose. She was still feeling sick so would like to know when she can receive her second dose and it's going to be after the three-week mark is that going to be a problem. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on an unspecified date. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100958348 same reporter/drug, different event/ patient

Other Meds:

Current Illness:

ID: 1522021
Sex: M
Age:
State: LA

Vax Date: 07/08/2021
Onset Date: 07/15/2021
Rec V Date: 08/03/2021
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: have both now been diagnosed with COVID; This is a spontaneous report from a contactable consumer. This consumer reported for a 21-year-old male patient (Reporter's son) received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, Batch/ lot number was not reported), via unspecified route on 08Jul2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 patient experienced Covid-19, Caller is looking for information about when her and son could get the second dose, patient was feeling better now and their Primary care physician said he could go ahead and proceed and get his scheduled second dose on 29Jul2021, the patient had COVID-19 Test on15Jul2021 and result was positive. The outcome of event was recovered in Jul2021. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100958348 same reporter/drug, different event/ patient

Other Meds:

Current Illness:

ID: 1522022
Sex: M
Age:
State: NY

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/03/2021
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: After second dose caller had COVID; After second dose caller had COVID; This is a spontaneous report from a contactable consumer (patient himself) via a Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in January2021 as dose 1, single; second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in February 2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient after second dose the patient had covid. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on an unknown date in 2021.Patient treated with monoclonal antibodies. The reporter states that he really wants to know if the booster is going to be the same as the other two doses because he had no effects from them whatsoever. COVID-19 and circulating mutations, the companies provided an update on booster dosing on 09Jul2021. Please note that the use of a 3rd or booster dose is not recommended or authorized and Pfizer does not suggest the use of the vaccine in any manner other than as described in the authorized EUA Prescribing Information authorized product monograph. Initial data from the ongoing study of booster doses demonstrated a consistent tolerability profile and high neutralization titers against the wild-type virus (the naturally occurring non-mutated virus) and the Beta variant. It is thought that the effects seen against the Beta variant may also be seen in the Delta variant. We are doing studies to confirm this. We expect to publish the data soon in a peer-reviewed journal and submit to regulatory authorities like the FDA in the coming weeks. Note to frontline: This FAQ should only be used if an HCP or non-HCP specifically asks about the Pfizer statement on booster doses. For HCPs with general inquiries about booster doses, please refer to the SRD titled "Administration of More Than a 2-Dose Series (Booster Dose)". Non-HCPs should be referred to their HCP for further discussion. The outcome of the events was unknown. There was no product quality complaint (PQC) present. The lot number for the vaccine was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100957896 Pfizer

Other Meds:

Current Illness:

ID: 1522023
Sex: F
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/03/2021
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: bell's Palsy; she experienced swelling of her left underarm where she got her shot.; Lymphadenopathy; experienced facial swelling (left side of her face); This is a spontaneous report from a non-contactable physician via Medical Information Team. A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration in the left arm on an unspecified date in Jan 2021 as dose 1, single for COVID-19 immunization. Medical history included covid-19 from Jul2020 to an unknown date. The patient's concomitant medications were not reported. The patient got her first dose of the Pfizer Covid 19 vaccine back in Jan and after her first dose On an unspecified date patient experienced swelling of her left underarm where she got her shot. Stated it was lymphadenopathy. patient also experienced facial swelling (left side of her face) and bell's Palsy. she went to her doctor and she was given Prednisone 50mg for 5 days as she was diagnosed of bells Palsy. patient wanted more information specific to Bells Palsy and patient was asking if she could get the second dose of the vaccine. The clinical outcome for the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected. ; Sender's Comments: based on the strong temporal relationship the events bells palsy , lymphadenopathy,facial swelling and the suspect vaccine BNT162B2 cannot be ruled out completely. 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1522024
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/03/2021
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: thyroiditis subacute; Blood thyroid stimulating hormone decreased; Iodine uptake decreased; Lymphocyte count decreased; Monocyte count increased; Red blood cell sedimentation rate increased; Serum ferritin increased; Thyroxine free increased; Tri-iodothyronine free increased; Pyrexia; This is a spontaneous report from a non-contactable consumer. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 44-years-old) for COVID-19 immunization. Medical history included Gilbert's syndrome; Ragweed allergy; COVID-19, showed as past COVID-19 infection (acute infection excluded via antigen test). Concomitant medication included ascorbic acid, colecalciferol, potassium, selenium; all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (Batch/Lot number and Expiration date: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single was taken for covid-19 immunization. The patient experienced thyroiditis subacute, Blood thyroid stimulating hormone decreased, Iodine uptake decreased, Lymphocyte count decreased, Monocyte count increased, Pyrexia or Fever of 40 centigrade for 36 hours, Red blood cell sedimentation rate increased, Serum ferritin increased, Thyroxine free increased, Tri-iodothyronine free increased. The patient underwent lab tests and procedures which included antibody test: covid on showed past COVID-19 infection (acute infection excluded via antigen test), blood thyroid stimulating hormone: decreased, body temperature: 40 centigrade for 36 hours, iodine uptake: decreased, lymphocyte count: decreased, monocyte count: increased, red blood cell sedimentation rate: increased, serum ferritin: increased on, thyroxine free: increased, tri-iodothyronine free: increased, radioactive iodine uptake test (RAIU): almost zero TC99 uptake in the thyroid; all on unspecified date. Outcome of the events was not recovered. No follow up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds: ASCORBIC ACID; COLECALCIFEROL; POTASSIUM; SELENIUM

Current Illness:

ID: 1522025
Sex: M
Age:
State: NV

Vax Date: 02/22/2021
Onset Date: 07/25/2021
Rec V Date: 08/03/2021
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: Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 at 10:00 (at the age of 68-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included lisinopril 20 mg and atorvastatin 10 mg both were taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). Patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Had no known allergies. Facility type vaccine: Doctor's office/urgent care. Other vaccine same date product: Pfizer COVID 19 vaccine, on 22Feb2021, dose number: 2 administered in Left arm. On 25Jul2021 21:00, patient experienced bells palsy. Patient visited Emergency room/department or urgent care for event. The patient underwent lab tests and procedures which included blood work, Ct scan and x-rays with unknown results on unspecified date. Therapeutic measures were taken as a result of bells palsy. The outcome of event was recovering.

Other Meds: LISINOPRIL; ATORVASTATIN

Current Illness:

ID: 1522026
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/03/2021
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: My left arm went on full out shaking all over the place; but I can't eat anything.; nausea; fever; diarrhea; I was tired; This is a spontaneous report from a contactable consumer. An unspecified age 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 on an unspecified date as dose 1, single for Covid 19 immunization. The patient medical history included diabetic, heart failure. The patient concomitant medications were not reported. It was reported that, After the first dose of the vaccine, on an unspecified date, the patient had experienced nausea, fever, diarrhea that lasted all night and day. She did not eat all day until 6:30 tonight. She supposed to eat breakfast lunch and dinner, but she can't eat anything. She was tired. The patient had a bad tremor in the left leg which was the side she got her vaccine. Her left arm went on full out shaking all over the place. She was diabetic and on blood thinners. I am oxygen. She wanted to know she can get the second shot. They cannot tell her if she should receive the second dose of the vaccine or not. The patient wanted to know she can get the vaccine if she has a medical conditions. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1522027
Sex: M
Age:
State:

Vax Date: 04/01/2021
Onset Date: 07/24/2021
Rec V Date: 08/03/2021
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: confirmed covid-19 positive 7/26/21; confirmed covid-19 positive 7/26/21; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old male patient received BNT162B2, (Lot Number: en6205/ep7533), via an unspecified route of administration on 01Apr2021 as dose number unknown, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination. The patient confirmed COVID-19 positive on 24Jul2021. The events considered to be medically significant. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-COV-2 test, nasal swab: positive on 26Jul2021. It was unknown whether treatment was given for the events. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1522028
Sex: F
Age:
State: CO

Vax Date: 03/04/2021
Onset Date: 03/01/2021
Rec V Date: 08/03/2021
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: Terrible joint pain; Couldn't walk; Got worse after my second/ joint pain, couldn't walk and after 2nd dose 04Mar21 the s/s got much worst.; My immune system is freaking out!!; This is a spontaneous report received from a contactable consumer (patient). A 42-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration on 04Mar2021 (at the age of 42-years) as single dose for covid-19 immunization. Medical history included joint pain from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Lot Number: EL9264) via an unspecified route of administration on 09Feb2021 (at the age of 42-years) as single dose for covid-19 immunization and experienced very sick and it started 2 weeks after first vaccine, joint pain and it has gotten worse, couldn't walk. On an unspecified in Mar2021, the patient experienced terrible joint pain, couldn't walk, got worse after second/ joint pain, couldn't walk and after 2nd dose 04mar21 the s/s got much worst and immune system is freaking out. Clinical course included: it was reported that she has been very sick, and it started 2 weeks after her first vaccine on 09Feb2021 and got worse after her second. The patient had terrible joint pain and has been on prednisone since her 2nd shot on 04Mar2021. She was a normal healthy person before all this, and she was suffering. The patient had a doctor and rheumatologist who would tell her this is an adverse reaction the vaccine. The patient's immune system was freaking out. It was reported that she was living in hell right now since she got her COVID vaccine and 2 weeks after she had it, she had joint pain and it has gotten worse. She spoke with her doctor who said to get the second dose and then the joint pain was even worse, so she had gone to urgent care and she has now been on 5 months of prednisone and done all kinds of lab tests and just has had so many prescriptions and doctor bills and she does not know what was going on, but it was all right after the COVID vaccine. When the patient was probed for outcome and she stated that she was on prednisone now and was trying to taper down which was causing the symptoms to become worse again, so the pain was definitely increasing. The events terrible joint pain, couldn't walk and condition worsened resulted in emergency room visit. Therapeutic measures were taken as a result of events terrible joint pain, couldn't walk and condition worsened. The patient underwent lab tests and procedures which included investigation: all kinds of lab tests - unknown on an unspecified date in 2021. The outcome of events was not resolved.

Other Meds:

Current Illness:

ID: 1522029
Sex: F
Age:
State: NC

Vax Date: 02/01/2021
Onset Date: 04/10/2021
Rec V Date: 08/03/2021
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: Bell's palsy; This is a spontaneous report from a contactable other HCP. This 23-year-old non-pregnant nurse reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 01Feb2021 at 08:30 as dose 2 on left arm, single for COVID-19 immunization. The medical history of the patient and medications received in last two weeks were reported as none. The patient had no known allergies, was not diagnosed with COVID-19 prior to vaccination, had not been tested for covid-19 since vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. On 10Apr2021 at 07:00 AM the patient experienced Bell's palsy. The event resulted in physician office and emergency room visit. Therapeutic measures were received with 14 day course of prednisone, valacyclovir and eyedrops. The patient recovered/resolved with sequel. The device date was 28Jul2021. Information about Batch/Lot number was requested.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the event Bell's Palsy and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1522030
Sex: U
Age:
State: CO

Vax Date:
Onset Date:
Rec V Date: 08/03/2021
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: had symptomatic positive COVID test; had symptomatic positive COVID test; This is a spontaneous report from a contactable consumer. A contactable consumer reported similar events for 3 patients. This is one of 3 reports. A patient of unspecified age and gender 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 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior vaccinations were none. Patient had symptomatic positive COVID on an unspecified date. The patient underwent lab tests and procedures which included Symptomatic positive COVID test: positive 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: 1522031
Sex: F
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 08/03/2021
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: hearing loss; vision issues; feeling that her brain is "not right; ringing of the ears with high pitched frequency for 3 days; headaches; fatigue; blurry vision; pressure in her head and eyes; eye is inflamed; This is a spontaneous report from a contactable consumer. This 48-year-old female consumer (patient) reported for herself. A 48-year-old female 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 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included retinal detachment from 2015 to an unknown date; she had retinal detachment surgery 6 years ago. The patient's concomitant medications were not reported. It was reported that, the patient received her first dose of the vaccine and stated she experienced hearing loss, vision issues, feeling that her brain is "not right", blurry vision, pressure in her head and eyes, and her vision has decreased even though it has held steady for 4 years (on an unspecified date). Caller states the area around her eye is inflamed as well. Patient stated she had retinal detachment surgery 6 years ago and now has a buckle in her eye and her eye doctor thinks she could be rejecting the buckle and she was put on a steroid drop. Patient stated she has already spoken to her PCP, GYN, and eye doctor about her symptoms and was still feeling "not right".. Also stated that her hearing was restored but now it was like a muted high pitched frequency and ringing of the ears for 3 days. Caller states she knows the risks of the vaccine but now she is looking for answers. Caller states that the person that she reported this initially to, (name withheld), told her that Medical Information can give her advice about getting the second shot. Caller states her doctor told her that it isn't possible to tell if her symptoms are from the vaccine. Caller also states she would rather take the risk of covid and will likely not be getting the second shot Caller states that there was a lot of weird stuff that happened to her and that she is still experiencing after her first dose. Upon follow-up (28Jul2021); No new events to report. Wants to speak to medical information about whether she should get second dose of vaccine. States her doctors cannot make a direct connection between the Pfizer Covid vaccine and her symptoms or side effects she has been experiencing. General Practitioner has not heard anything negative about anyone who received the vaccines. Caller states she provided the lot number on her previous report. States she is supposed to get the second dose on Saturday. The outcome of events was unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1522032
Sex: F
Age:
State: NJ

Vax Date: 04/18/2021
Onset Date: 04/24/2021
Rec V Date: 08/03/2021
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: Severe abnormal chest pain (diagnosed as enlarged heart); Severe abnormal chest pain (diagnosed as enlarged heart); This is a spontaneous report from a contactable consumer (patient herself). A 26-year-old non-pregnant female patient received bnt162b2 (formulation: solution for injection; Lot Number: EW0151), dose 1 via an unspecified route of administration administered in left arm on 18Apr2021 at 13:00 (at the age of 26 years) as dose 1, single for covid-19 immunisation. Medical history included allergy to peanuts from an unknown date. The patient's concomitant medications were not reported. The patient previously took bactrim and had allergies. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe abnormal chest pain (diagnosed as enlarged heart) on 24Apr2021.Event caused emergency room/department or urgent care. Device Date was 28Jul2021. Therapeutic measures were taken as a result of severe abnormal chest pain (diagnosed as enlarged heart) with imaging. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1522033
Sex: M
Age:
State: CA

Vax Date: 04/01/2021
Onset Date: 07/28/2021
Rec V Date: 08/03/2021
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: Received both doses Pfizer Covid Vaccine beginning 01Apr2021 and second dose was received three weeks later and just tested positive for Covid; Received both doses Pfizer Covid Vaccine beginning 01Apr2021 and second dose was received three weeks later and just tested positive for Covid; Quite a bit of fever; Headache is mild; This is a spontaneous report from a contactable consumer (patient). A male patient of 64-year-old received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was ER8737or ER8037), first dose on Right shoulder via an unspecified route of administration on 01Apr2021 (Age at vaccination 64-year-old) as dose 1 single for COVID-19 immunization and patient received second dose also for bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was ER8729), on Right shoulder via an unspecified route of administration on 22Apr2021 for COVID-19 immunization. No medical history reported. Concomitant medications include Ibuprofen 200mg (Just prior to Covid vaccine). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After Receiving both doses Pfizer Covid Vaccine patient tested positive for Covid on 28Jul2021. Patient also experienced fever and mild headache. Patient underwent lab test and procedures SARS-CoV-2 test was positive on 28Jul2021. QA Review & Rationale:The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect of lot ER8729 of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The initial scope of this investigation is limited to the reported finished goods lot ER8729, fill lot EP8681, and the bulk formulated drug product lot EP8568. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. Summary of Investigation: The initial scope of the investigation was limited to the reported finished goods lot ER8729, fill lot EP8681, and the bulk formulated drug product lot EP8568. Based on the results of the investigation, the scope was not expanded. Manufacturing and packaging batch records were examined for the reported complaint lot.Pfizer withheld QO did not receive photographs or a complaint sample for examination. The complaint was not confirmed. No probable root cause for the complaint related to the manufacturing process of the reported lot was identified. There were no corrective or preventative actions taken as a result of this complaint investigation. No related quality issues were identified during the investigation. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The drug product is stored at controlled refrigeration throughout the manufacturing process and a log is maintained documenting the elapsed time out of refrigeration. A review of the logs confirmed that all times were within allowable limits. The product also requires storage in ultra-low temperature freezers following the packaging of the product. A review of the freezer temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. The results of all analytical tests performed at the time of lot release confirmed that the batch meets potency specifications. There is no impact to the quality of the lot. It is unknown how the product was handled, stored, or administered after it left the origin site.Root Cause Analysis/Identify: Pfizer withheld Quality Operations could not indicate a probable root cause for the complaint to be related to the production process of the involved batch. Review of the manufacturing and packaging batch records and release test results confirmed that the batch meets potency specifications. It is unknown how the product was handled, stored, or administered after it left the Pfizer withheld site. Impact Analysis: Based on the final scope of the investigation, which was limited to the reported finished goods lot and associated fill and formulated drug product lots, and that a root cause related to the production process was not identified, the reported issue is not representative of the lot and does not indicate a negative impact on product quality. No regulatory notification is required. Corrective / Preventive Action: There were no corrective actions as a result of this complaint investigation. The results of all tests, inspections, and in-process controls have been reviewed and all results met the established requirements prior to the release of the reported batch for distribution. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8729 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8729, fill lot EP8681, and the formulated drug product lot EP8568. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The outcome of Events was unknown. The lot number for the vaccine was not provided and will be requested during follow up.

Other Meds: IBUPROFEN

Current Illness:

ID: 1522034
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/03/2021
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: nausea; vomiting; headache; felt really bad; This is a spontaneous report from a non-contactable Pfizer colleague (patient). A female 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 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. On unspecified date, the patient experienced nausea, vomiting, headache and felt really bad. Patient was going home, and she started to feel nausea, vomiting, and then felt she could not go any longer but then she felt she could still go, so she called her husband and she said that if he could help her. So, then she did not really feel bad and then she went on and on and on and she suddenly realized that she was feeling vomitish. Patient vomited and then she felt headache and so she laid down there and then. Later she called the doctor and the doctor arrived. So that was how sequence of events that occurred. It was reported that now she was feeling better, and she thought that she does not really need help. But She was still going ahead and calling, so that was the whole story. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1522035
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/03/2021
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: 2 different antibody tests and both test showed 0 antibodies for the COVID19 virus; lymphocyte counts were at 0.40 and now it was down to 0.24; This is a spontaneous report. A contactable 67-year-old female consumer (patient) reported for herself that: The 67-years-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patient had medical history of multiple sclerosis for which patient was taking Gilenya. The concomitant medications were not reported. Patient reported that she took 2 different antibody tests and both tests showed 0 antibodies for the COVID 19 virus. She also reported that prior getting the vaccine her lymphocyte counts were at 0.40 and now it was down to 0.24. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1522036
Sex: M
Age:
State: NY

Vax Date: 07/26/2021
Onset Date: 07/01/2021
Rec V Date: 08/03/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Mild headache; sore arm; tired; he got light headed and dizzy that lasted for 30 minutes; This is a spontaneous report from a contactable consumer. This consumer (Patients wife) reported for a patient (Reporters husband). A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FA7484), dose 1 via an unspecified route of administration, administered in left arm on 26Jul2021 14:00 (at the age of 49-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included high cholesterol. Concomitant medications were not reported. On unspecified date in Jul2021, the patient experienced mild headache, sore arm, tired and he got light headed and dizzy that lasted for 30 minutes. It was stated all these side effects are from the first dose and her husband right when he got injected he could feel the medication going through his blood stream, he got light headed and dizzy that lasted for 30 minutes, then he had a headache from that day, and he felt tired, and had a sore arm that still hurts today. The headache was the day of the vaccine and was relieved with motrin. Adds all his side effects were gone after about 30 minutes that day. The only thing he still has is a sore arm. The vaccination sites will monitor patients for at least 15min in case there is an allergic reaction, may refer to the vaccination site for more specific information. No specific statistical data is available but it's possible that severe reactions occurred, they may be reactions that were not in the clinical studies. Patient will get second dose on 16Aug2021. Treatment included motrin. Outcome of the event sore arm was recovering. Outcome of the other events was recovered on unspecified date in Jul2021.

Other Meds:

Current Illness:

ID: 1522037
Sex: F
Age:
State: IL

Vax Date: 01/29/2021
Onset Date: 02/09/2021
Rec V Date: 08/03/2021
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: Heart palpitations; This is a spontaneous report from a contactable consumer (patient reported for herself). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jan2021 (at the age of 69-year-old) (Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included hypertension and blood cholesterol increased. The patient had no Covid prior vaccination. The patient had Known allergies to beta blockers. Concomitant medication(s) included TRIAMTERENE, DILTIAZEM, ATORVASTATIN, CALCIUM and colecalciferol (VITAMIN D), all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient had not been covid tested post vaccination. The patient experienced heart palpitations on 09Feb2021. The outcome of the event was not resolved at the time of this report. Information on Lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds: TRIAMTERENE; DILTIAZEM; ATORVASTATIN; CALCIUM; VITAMIN D

Current Illness:

ID: 1522038
Sex: F
Age:
State: IN

Vax Date: 02/07/2021
Onset Date: 02/07/2021
Rec V Date: 08/03/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: headache; heart pounding; her arm was really sore; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old female patient received (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Lot number and expiry date was not reported) via an unspecified route of administration on 07Feb2021 as a dose 1 single for covid-19 immunization. Medical history included brain neoplasm from 1995 to an unknown date Stated she has brain tumour and never experienced nothing this bad. Stated that she was diagnosed with a brain tumour malignant in 1995 and has an MRI every year for growth. The patient's concomitant medications were not reported. The patient reported that she had a couple of things happen since her Pfizer Covid vaccination on 07Feb2021.She stated that 10 minutes after the vaccination on the same day, her heart pounding and she dropped the paper with the side effects on the floor and for the time it took for her husband to pick it up that it was gone. The patient reported that heart pounding was short and It happened when she was waiting at the clinic for 15 minutes. The patient reported that it did not last long. The patient reported that she did not report while she was there. The patient came home, did the floors, went to bed and her arm was really sore. On an unspecified date (at 03:00), she had a horrible headache. The patient reported that it did not last all night, but she went to sleep. The patient reported that she tossed and turned. She got up the next morning and it was fine. The patient reported that it was not a severe reaction. The patient wanted to know if she could still get the second dose on 05Mar2021. Outcome of the events was recovered on an unspecified date in 2021. Follow-up (12May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1522039
Sex: M
Age:
State: NY

Vax Date: 02/16/2021
Onset Date:
Rec V Date: 08/03/2021
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: my fingers are tinlgy and sort of yellowishy; my fingers are tinlgy and sort of yellowishy; This is a spontaneous report from a Contactable Consumer (patient). A 49-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced my fingers are tinlgy and sort of yellowishy on an unspecified date. It was reported that, the patient received first dose of Pfizer-BioNTech COVID-19 Vaccine on 16Feb2021, and experienced "I waited for half an hour or so (after receipt of vaccine), it's freezing here, I took my gloves off and noticed my fingers are tinlgy and sort of yellowishy. Fingers were feeling tingly and turning yellow, looks like it is Dark, the skin, underneath my fingernails." Outcome of the event was unknown. Information on the lot/ batch number has been requested. Follow-up (11May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1522040
Sex: F
Age:
State: NJ

Vax Date: 02/19/2021
Onset Date: 02/20/2021
Rec V Date: 08/03/2021
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: Racing of heart; Swelling of hand/fingers & feet/toes; Burning sensation in veins; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm left on 19Feb2021 10:15 (Batch/Lot Number: EL9266) as single dose for COVID-19 immunisation. Medical history included diabetes and high blood pressure from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin, vitamin D3 and aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported. Prior and post to vaccination, the patient was not diagnosed with COVID-19. On 20Feb2021, the patient experienced swelling of hand/fingers & feet/toes, racing of heart; burning sensation in veins and dizziness. It was reported she felt better now. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: METFORMIN; VITAMIN D3; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1522041
Sex: F
Age:
State: WA

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 08/03/2021
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: Heart palpitations; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 80-years-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration on 04Feb2021 at 14:00 as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05Feb2021 at 06:00, the patient was awakened or woke up with heart palpitation which lasted less than a minute and then patient got up. Patient reported that last Thursday (2 weeks after administration), she was awakened by heart palpitations again, in which both times they have stopped by the time she was up on her feet. The outcome of the event was recovered on the same day. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1522042
Sex: F
Age:
State: TN

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/03/2021
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: Heart palpitations; chills; fever; body aches; weakness; This is a spontaneous report from a contactable 66-year-old female Other HCP reported for herself (patient). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number was not reported) via an unspecified route of administration in right arm on 29Dec2020 05:00 (at the age of 66 years) as dose 1, single for COVID-19 immunisation at hospital. Medical history included heart disease from an unknown date and unknown if ongoing other medical history, known allergies to medications, food, or other products from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Dec2020, 20:00 the patient experienced heart palpitations, chills, fever, body aches, weakness. No treatment was received for events. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number was not reported) via an unspecified route of administration in right arm on 15Jan2021 04:30 as dose 2, single (at the age of 66-years-old) for COVID-19 immunisation at hospital. The case was reported as non-serious with no seriousness criteria (Results in death/ Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/ Congenital anomaly/birth defect). The clinical outcome of the events was not resolved. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1522043
Sex: F
Age:
State: OH

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/03/2021
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: exhaustion; Injection site soreness; extreme hot flashes; nausea; maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer or other non hcp. This consumer or other non hcp reported information for both mother and fetus/baby. A 29-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number : Not known), via an unspecified route of administration, administered in Arm Left on 26Feb2021 11:30 (at the age of 29-years-old) as dose 1, single for COVID-19 immunisation. Medical history were none. The patient's concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 26Feb2021 11:30 , the patient experienced maternal exposure during pregnancy. The patient's last menstrual date was on 20Sep2021. On 26Feb2021 12:30, patient experienced exhaustion, injection site soreness, extreme hot flashes, nausea. The mother reported she became pregnant while taking BNT162B2. The mother was 25 Weeks pregnant at the onset of the event. The mother was due to deliver on 09Jun2021. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of events. The outcome of the events were recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1522044
Sex: M
Age:
State: VA

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 08/03/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Heart palpitations; Little zinging feeling; This is a spontaneous report from a contactable consumer(patient). A 68-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EN6201; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left at the age of 68-year-old on 12Feb2021 11:30 as dose 1, single for covid-19 immunization. The patient's medical history included cholesterol. Concomitant medication included simvastatin taken for blood cholesterol. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. No other additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. AE(s) following prior vaccinations was reported as none. The patient stated that he had his first Pfizer shot on the 12Feb2021. He really did not have a reaction right that time. He had a little zinging feeling in the first hour or so. No feedback though. Heart palpitations started on 13Feb2021 in the afternoon. Caller clarified that it was more like 30 hours after receiving the injection, not 24 hours. He went to the Emergency Room. They did an EKG and blood work. The EKG and blood work were normal. All his enzymes were perfect. No indication of heart attack. They repeated EKG and blood work after several hours and there were no problems. They encouraged him to see his doctor. He went to the ER on 15Feb2021. By the evening of 17Feb2021 he had no palpitations and has felt fine ever since. He was scheduled to get second shot that week. He asked if he should have the shot. Caller clarified shot as COVID19 Vaccine. Caller clarified his question. Have other people had this symptom? Have they had this symptom and had the second one and been ok or do they avoid it? He knew this was new, but even after one shot there was quite a bit. He saw his physician on 16Feb2021, who has seen him for 20 years and he thought it was related to the shot. The patient underwent lab tests and procedures which included blood test: normal, electrocardiogram: normal, investigation: normal on an unspecified date. The outcome of event heart palpitations was recovered on 17Feb2021, while the other event little zinging feeling was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: SIMVASTATIN

Current Illness:

ID: 1522045
Sex: M
Age:
State: WA

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/03/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Moderate to Severe joint pain; High temperature of 103.0; Moderate chills and shaking; Moderate chills and shaking; Severe fatigue; sore eyes and eye brows; moderate to severe headache; loss of apetite; moderate to severe swelling on upper back of neck with prominent lumps on both sides; moderate to severe swelling on upper back of neck with prominent lumps on both sides; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 81-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in arm left on Feb2021 at 10:45 as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in arm left on Feb2021 at 10:45 as dose 2, single for COVID-19 immunisation. Medical history was none. Concomitant medications included ibuprofen and daily vitamins. The patient previously took feldene and experienced drug hypersensitivity. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not tested for COVID tested post vaccination. The patient experienced moderate to severe joint pain, moderate to severe swelling on upper back of neck with prominent lumps on both sides, high temperature of 103.0, moderate chills and shaking, severe fatigue, sore eyes and eye brows and moderate to severe headache and loss of appetite. The patient underwent lab tests and procedures which included body temperature: high temperature of 103. Therapeutic measures were not taken as a result of the events. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: IBUPROFEN

Current Illness:

ID: 1522046
Sex: F
Age:
State: MA

Vax Date: 02/08/2021
Onset Date:
Rec V Date: 08/03/2021
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: Caller had a vaccine last week, severe reaction, difficulty breathing.; felt strange right away.She was kind of out of it.; hard time walking; heart beating so strong; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809, Expiration date: Unknown), via an unspecified route of administration, in right arm on 08Feb2021 at 14:00 (at the age of 86-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included thyroid disorder from an unknown date and unknown if ongoing, ongoing urinary tract disorder, mastectomy, and lymphadenectomy from an unknown date and unknown if ongoing 35 years ago, on the right side. Investigations were unknown. The patient had no family medical history. The patient concomitant medications were reported as unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of Pfizer suspect was administered. Adverse events follow prior vaccinations was reported as none. On an unspecified date, caller had a vaccine in the last week and experienced severe reaction, difficulty breathing, felt strange right away. she was kind of out of it, hard time walking, heart beating so strong. It was reported that, had COVID vaccine three weeks ago and had very severe side effects. was told to call on morning of second COVID vaccine to see if she should get it or not. She was due for her second COVID vaccine today, 01Mar2021 at 2PM. When she had the side effects, she was taken care of. Her blood pressure and heart rate were taken. She was kept there for quite some time. She left without asking if she should get the second COVID shot or not. Already had an appointment with him Friday and went over her severe side effects. (Name) could not come up with an answer as to if she should receive the second COVID shot. One of her papers says, "people who should not get a second shot is if you had severe side effects, "but she never discussed that with the vaccination clinic. She was on the phone all day yesterday and did fill out some questions. She spoke with someone who had communication issues. She does not have a reference number and could not confirm if she filed a report with Regulatory Authority. Clarified severe side effects as soon as the needle went into her arm, she felt strange right away. She was kind of out of it. She got up to go to the room and had a hard time walking. She felt her heart beating so strong in her chest that she could almost see it. She was not nervous going in, but very relaxed. Her heart was beating very quickly after the COVID shot. She did not want to tell anyone initially. After a nurse came by and asked if she was ok, she finally admitted she was not. She was then taken by the nurse at the vaccine clinic where caller was worked on. She was never told if she should receive the second vaccine or not. It lasted a while at the vaccine clinic, maybe a good 30-40 minutes and she was fine when she came home. Stated she received first dose COVID Vaccine three weeks ago on 01Mar2021 but provided date of 08Feb2021 from patient record card. Wondered if that has anything to do with it. She has not been able to get any blood taken on the right arm until 6 months ago. She had blood work done yesterday and it was drawn from her left arm. No adverse event required a visit to emergency room. Had an appointment last week for a regular physical. She came straight home after the COVID vaccine because she felt fine. At the end of her regular physical, her primary care said maybe she could get the second COVID vaccine. Her reaction kind of scared her. The patient underwent lab tests and procedures which included blood pressure measurement: unknown result on, heart rate: unknown result. No product complaint was reported. The outcome of the events was reported as unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Urinary tract disorder

ID: 1522047
Sex: F
Age:
State: PA

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 08/03/2021
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: has a bad ankle; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took ibuprofen. Caller asked if she can take ibuprofen after the first dose since she has a bad ankle. She took ibuprofen before she took the vaccine. The outcome for all events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1522048
Sex: F
Age:
State: MA

Vax Date: 02/23/2021
Onset Date: 03/04/2021
Rec V Date: 08/03/2021
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: Itching and burning of my feet; Itching and burning of my feet; My body was painfully itchy and burning; My body was painfully itchy and burning; My body was painfully itchy and burning; Red blotches on various areas of my body, including chest, back, buttocks, thighs, knees, and feet; My heart was racing; Finally fell asleep about 4:00 AM on Friday/Interrupt my sleep; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809), via an unspecified route of administration in arm left on 23Feb2021 at 14:00 (at the age of 67-year-old) as a dose 1, single for COVID-19 immunisation. The patient's medical history included known allergies: some cosmetic or cleaning products, so she use only natural dye-free, fragrance-free, preservative-free products. The patient's concomitant medications in two weeks were reported as no. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. The patient stated that, prior to falling asleep on Thursday, 04Mar2021 at 11:45 PM, her heart was racing and she finally fell asleep about 4:00 AM on Friday. On Friday, 05Mar2021, the patient was awoke at 7:00AM. Stated that, her body was painfully itchy and burning. There were red blotches on various areas of her body, including chest, back, buttocks, thighs, knees and feet. It became so unbearable that she finally took an antihistamine and fell asleep. The same thing occurred Friday night into Saturday morning and Saturday night into Sunday morning, but to a much lesser degree. Stated that, the worst part of it on Saturday morning and Sunday morning was the itching and burning of her feet accompanied by a big red blotch. This passed after a couple of hours. Stated that, on Sunday night, the patient heart was racing and she took an antihistamine before sleeping for fear of experiencing the itching that might once again interrupt her sleep. Stated that, this morning upon awakening, the patient did not experience the severe itching and burning of her feet, just some light itching of her body. Treatment medication included was antihistamine. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1522049
Sex: F
Age:
State:

Vax Date: 03/07/2021
Onset Date: 03/07/2021
Rec V Date: 08/03/2021
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: Heart racing and difficulty breathing after 12 hours of the first shot; Heart racing and difficulty breathing after 12 hours of the first shot; This is a spontaneous report from a non-contactable consumer (patient). A 33-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 07Mar2021 12:00 (age at the time of vaccination was 33-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced heart racing and difficulty breathing after 12 hours of the first shot on 07Mar2021. Seriousness Criteria-Persistent, AE required visit to: Physician office. The outcome of event was Recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1522050
Sex: M
Age:
State: PA

Vax Date: 03/05/2021
Onset Date: 03/01/2021
Rec V Date: 08/03/2021
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: heart racing; feeling a little uncomfortable; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 05Mar2021 (Lot number and Expiry date was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced Heart racing on, Feeling a little uncomfortable on Mar2021. The patient underwent lab tests and procedures which included heart rate: heart racing on Mar2021. He reports that afterwards he woke up in the middle of the night with his heart racing, heart rate: subsided on Mar2021, he mentioned that he hadn't taken his blood pressure medication yet, so he took it then, a few hours later his heart rate had subsided. Therapeutic measures were taken as a result of heart racing. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained

Other Meds:

Current Illness:

ID: 1522051
Sex: F
Age:
State: CA

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 08/03/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: heart suddenly started racing; felt dizzy and very light headed; This is a spontaneous report from a contactable consumer, the patient. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ENG911), via an unspecified route of administration, administered in Left arm, on 09Mar2021 at 13:00 as dose 1, single for covid-19 immunization. Medical history included Hyperthyroidism due to toxic nodule from an unknown date and unknown if ongoing. Concomitant medications included sertraline hydrochloride (ZOLOFT, 100 mg, daily) and thiamazole (TAPAZOLE, 0.5 DF, 2x/week / 1/2 tab Tapazole 2xweek), both taken for an unspecified indication, start and stop dates were not reported. The patient previously took epinephrine and had the same reaction (Known allergies: have the same reaction to epinephrine). The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with covid prior vaccination and no covid test was dose post vaccination. On 09Mar2021 at 01:00 PM, the patient had within one minute of injection, her heart suddenly started racing and she felt dizzy and very lightheaded. No corrective treatment was received for the events. The outcome of the events was Recovered with lasting effects on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds: ZOLOFT; TAPAZOLE

Current Illness:

ID: 1522052
Sex: F
Age:
State: TX

Vax Date: 03/11/2021
Onset Date:
Rec V Date: 08/03/2021
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: High blood pressure and cholesterol; High blood pressure and cholesterol; Sinusitis; allergy; This is a spontaneous report from a contactable consumer (patient). A 40- year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 14:30 (40- year-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. Concomitant medication(s) included lisinopril taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (CETRIZINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. No prior covid vaccination was taken. Therapeutic measures were taken as no for all event. The patient experienced high blood pressure and cholesterol, sinusitis/ allergy on 18Sep2020 (as reported). The outcome of all event was recovering. Information on Lot/Batch number was available. Additional information has been requested

Other Meds: LISINOPRIL; ATORVASTATIN; CETRIZINE

Current Illness:

ID: 1522053
Sex: F
Age:
State: CA

Vax Date: 12/21/2020
Onset Date: 12/22/2020
Rec V Date: 08/03/2021
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: Heart palpitations; Constant cranial head/neck muscle tension; This is a spontaneous report from a contactable nurse (patient). A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EK5730), dose 1 intramuscular, administered in arm left on 21Dec2020 14:00 (at the age of 48-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Hospital. Medical history included hypothyroidism. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included levothyroxine sodium (SYNTHROID), vitamins nos (DAILY VITAMINS). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Dec2020, the patient experienced heart palpitations, constant cranial head/neck muscle tension. Heart palpitations required ER visit and cardiac consult. Constant cranial head/neck muscle tension also required ER and physician visit. The patient underwent lab tests and procedures which included thyroid/hormone: unknown results and cardiac evaluation: unknown results on unspecified date, Covid test PCR (Nasal Swab): negative on 30Dec2020. Patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3249), dose 2 intramuscular, administered in arm left on 11Jan202112:00 PM as DOSE 2, SINGLE for covid-19 immunisation at Hospital. Therapeutic measures were taken as a result of heart palpitations, constant cranial head/neck muscle tension. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.

Other Meds: SYNTHROID; DAILY VITAMINS

Current Illness:

ID: 1522054
Sex: M
Age:
State: NY

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 08/03/2021
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: Heart Palpitations; night sweat; chills; nausea; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration, administered in left arm on 03Mar2021 at 15:15 (at the age of 50-year-old) as dose 1, single for COVID-19 immunization at Hospital. Medical history included High cholesterol from an unknown date to unknown date, and that is now normal. Concomitant medication within two weeks included rosuvastatin taken for an unspecified indication, start and stop date were not reported. Known allergies included Tetracycline and a large dose of a beta blocker made patient pass out. No other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. On 03Mar2021 at 15:15, patient experienced night sweat, chills, nausea (widely reported). And on 10Mar2021, 7 days after taking vaccine the patient experienced heart palpitations. Adverse events resulted in physician office visit or clinic visit. Patient received Metoprolol as treatment for events. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: ROSUVASTATIN

Current Illness:

ID: 1522055
Sex: M
Age:
State: SC

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 08/03/2021
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: like I was sleepy and wanted to lay down; really really sleepy; right leg from hip to knee started hurting to the point he couldn't get comfortable; constant pain like something was inside trying to get out; felt really groggy; When she gave him the shot it bled and she got some blood on his shirt and he isn't blaming her but he was surprised it bled like that; yawning; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received first dose of bnt162b2 (Solution injection, Batch/Lot Number: EN6204, Expiration date: UNKNOWN), via an unspecified route of administration, administered in Arm Right on 11Mar2021 at 12:15 as single dose (at the age of 63-years-old) for covid-19 immunisation. Medical history included ongoing arthritis. He may have to have a knee replacement because the arthritis is pretty bad in his right knee and it swells up from time to time. Plus they gave him a brace that goes over his knee when he stands up so he has a lot of support. There were no concomitant medications. Patient did not receive any prior vaccinations within 4 weeks. Patient stated that he received the first injection and it scared him. He sat there for 15 minutes after the injection and it was fine. He had to drop something off at someone's house. Then when he was there he got sleepy and he said he had to go home to take a nap. He laid down to take a nap then all of a sudden he felt really really sleepy. All of a sudden, his right leg all the way from his hip to his knee, he does have arthritis in his knee, they are talking about doing a knee replacement and he doesn't know if that plays a role in this or not. However, all of a sudden it started hurting to the point where he could not get comfortable. He tried everything, all positioning, anything he could do, for about 30 mins at least, maybe longer, it was just constant pain like something inside was trying to get out. It was a weird feeling. He questioned if it could have happened because he has trouble with knee. He feels awake today, it hit him yesterday, he felt really groggy, he started feeling kind of groggy and started yawning. By the time he made it home then he was ready to lay down. However, the leg hadn't started hurting. When he did finally lay down, his leg really set in. It's not hurting like it did yesterday. Yesterday was tremendous hurt. It's sore today. When she gave him the shot it bled and she got some blood on his shirt and he isn't blaming her but he was surprised it bled like that. She put a band aid on it and got the bleeding stopped. The patient stated he experienced fatigue "like I was sleepy and wanted to lay down," pain on his right side (the side he received his injection, in his hip down to his knee. Patient stated, "it was not mild pain it was like someone was inside of my leg trying to beat out. Patient thought about calling someone to take him to the hospital." However, patient stated it lasted for about an half an hour to an hour. Patient stated the pain was intense. Patient asked was this something commonly reported, will he experience this with his second injection, and should he take his second injection. Caller stated he is scheduled for his second vaccination on 29Mar2021. The outcome of the events really really sleepy and when she gave him the shot it bled and she got some blood on his shirt and he isn't blaming her but he was surprised it bled like that was recovered. The outcome of the event right leg from hip to knee started hurting to the point he couldn't get comfortable was recovering while the outcome of constant pain like something was inside trying to get out, yawning, like I was sleepy and wanted to lay down and felt really groggy was unknown.

Other Meds:

Current Illness: Arthritis

ID: 1522056
Sex: F
Age:
State: TX

Vax Date: 02/27/2021
Onset Date: 02/28/2021
Rec V Date: 08/03/2021
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: Felt heart palpitations which doctor then defined as premature atrial complex (PAC). This hasn't happened to me before and started the day after getting the vaccine.; Felt heart palpitations which doctor then defined as premature atrial complex (PAC). This hasn't happened to me before and started the day after getting the vaccine.; This is a spontaneous report from a contactable consumer or other non hcp. A 27-years-old non-pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in arm right on 27Feb2021 13:00 (age at vaccination: 27-years-old) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing and food allergy from an unknown date and unknown if ongoing Known allergies: I think I'm allergic to eggs, but not confirmed. Patient did not received other vaccines within 4weeks prior to vaccination. The patient concomitant medications were not reported patient was not tested to post vaccination. On 28Feb2021, the patient experienced felt heart palpitations which doctor then defined as premature atrial complex (Pac). This had not happened to me before and started the day after getting the vaccine. Patient had physician office visit for the events and patient did not had any treatment for the events. The outcome of the events palpitations and supraventricular extra systoles was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1522057
Sex: M
Age:
State: CA

Vax Date: 03/12/2021
Onset Date: 03/13/2021
Rec V Date: 08/03/2021
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: I had put on compression sleeve for both my knees on Saturday. Sunday my left knee was bruised in two places where the sleeve was at.; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 59-year-old male patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Lot number: EN6201), via an unspecified route of administration in right arm on 12Mar2021 at 09:00 (at the age of 59-year-old) as single dose for COVID-19 immunisation. It was other facility type vaccine. The patient's medical history was hypertension and allergic to Penicillin. Concomitant medications in two weeks included Losartan and Tamsulosin from an unknown date. No other vaccine in four weeks. On 13Mar2021 at 09:00, the patient had put on compression sleeve for both my knees on Saturday. Sunday my left knee was bruised in two places where the sleeve was at. No covid prior vaccination. Post vaccination no covid tested was performed. No treatment was received for adverse event. The outcome of the adverse event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: LOSARTAN; TAMSULOSIN

Current Illness:

ID: 1522058
Sex: F
Age:
State: NY

Vax Date: 03/14/2021
Onset Date: 03/15/2021
Rec V Date: 08/03/2021
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: Heart palpitations; headache; dizziness; This is a spontaneous report from a contactable Consumer (patient herself). A 27-years-old non- pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, lot number: EN6208, expiry date: unknown) via unspecified route of administration, administered in right arm on 14Mar2021 15:15 (age at vaccination: 27-years) as DOSE 1, SINGLE for Covid-19 immunization. Facility type vaccine other was state organization. Medical history of patient included migraines and penicillin allergy from an unspecified date and unknown if ongoing. Concomitant medications were not reported. No other vaccine was administered in four weeks. The patient had surgery / general anesthesia on 09Mar2021 (in two weeks of vaccination). The patient experienced heart palpitations, headache, dizziness on 15Mar2021 12:00. Prior to and since vaccination the patient was not tested positive for covid. Treatment regimen was not given as a result of the adverse events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1522059
Sex: F
Age:
State: VA

Vax Date: 03/05/2021
Onset Date: 03/08/2021
Rec V Date: 08/03/2021
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: heart palpitations; sore arm; body ache; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 62-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included Hypertension, Hypothyroidism, arthritis. The patient's concomitant medications were not reported. The patient reported that she received the 1st dose "06Mar2021 (as reported) and 3 days later she had heart palpitations and she never had that before and it lasted for 3 days on and off, one days it lasted for a few hours. It's gone now, just had the occasional flip flop of her heart. She also had a sore arm and body ache". She spoke to her doctor and he said to call Pfizer. The patient got her 1st dose on 05Mar2021 and on 08Mar2021 she started having heart palpitations and read that it is a side effect, but she wanted to know if it's safe for her take her 2nd dose. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1522060
Sex: M
Age:
State:

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 08/03/2021
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: heart palpitations; he has an incomplete right bundle branch; This is a spontaneous report from a contactable consumer or other non hcp. A 21-year-old male patient received (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration on 16Mar2021 (at the age of 21-year-old) as DOSE 1, single for covid-19 immunization. Patient medical history and concomitant medications were not reported. The patient received first dose of Pfizer vaccine on 16Mar2021 and within first 25 minutes developed heart palpitations. When he went home his heart rate was in the 110's. He went to the emergency room and had an EKG and his heart rate ranged from 88-110. The doctor said that he has an incomplete right bundle branch and he had to follow up with a cardiologist. The patient was asking whether this a dangerous side effect. Outcome of the events was unknown No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1522061
Sex: F
Age:
State: MS

Vax Date: 03/06/2021
Onset Date: 03/07/2021
Rec V Date: 08/03/2021
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: heart racing and beating very hard; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6201), via an unspecified route of administration in the left arm on 06Mar2021 at 09:45 (at the age of 57-years-old) as a dose 2, single for COVID-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9261), via an unspecified route of administration in the left arm on 29Jan2021 at 09:15 (at the age of 57-years-old) as a dose 1, single for COVID-19 immunization. The most recent COVID-19 vaccine was administered in the public health clinic facility. Medical history included High blood pressure and rapid heart rate and meds control it. There were no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced heart racing and beating very hard on 07Mar2021 13:00 for about 45 min. The patient did not receive any treatment. The clinical outcome for the event was recovered on an unspecified date 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1522062
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/03/2021
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: Heart palpitation; pulse was over 100; blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: 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. After first shot of Pfizer week ago and patient had a reaction after 4 hours with heart palpitation and his pulse was over 100 and blood pressure was very high. The patient underwent lab tests and procedures which included blood pressure measurement with result high and heart rate with result over 100 on an unspecified date. Patient wanted to know should receive a second shot. Patient was informed about Pfizer Medical Information Department. The outcome of the reported events was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1522063
Sex: F
Age:
State: CA

Vax Date: 02/27/2021
Onset Date: 02/27/2021
Rec V Date: 08/03/2021
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: About an hour after the vaccine chest was pounding while vaccuuming/doing housework; Felt a fast heartbeat; Dizziness; Then skin felt hot as if I'd been running/ heat sensation in my skin.; This is a spontaneous report from a non-contactable consumer or other non hcp. A 36-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration, administered in left arm on 27Feb2021 (age at vaccination was 36-year-old) (Batch/Lot Number: EN6200) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not taking any other medications prior two weeks. The patient had no known allergies. On 27Feb2021, about an hour after the vaccine the patient experienced chest was pounding while vacuuming /doing housework, felt a fast heartbeat and dizziness. The patient was recovered after sitting down for a moment. Then skin felt hot as if she had been running, but she had not been running. she recovered within a couple hours from the heat sensation in her skin. No treatment was received for the events. The outcome the events was recovered on 27Feb2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1522064
Sex: F
Age:
State:

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 08/03/2021
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: I read that swollen lymph nodes is a possible side effect.; It's uncomfortable its not like painful but its very uncomfortable and tender.; tender; like a ball under my arm, swollen under my arm and in my armpit and down into like my breast tissue.; I couldn't even lay that way.; That evening my arm was sore; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Solution injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she went Tuesday afternoon and got her first covid shot. That evening her arm was sore and yesterday it continued to hurt and last night when she went to bed it was like there was something like a ball under her arm, swollen under her arm and in her armpit and down into like in her breast tissue. She couldn't even lay that way. She read that swollen lymph nodes was a possible side effect. It's uncomfortable it was not like painful but it was very uncomfortable and tender. Caller asked, is that what she was experiencing a swollen lymph node and should she get it checked out. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1522065
Sex: F
Age:
State: WY

Vax Date: 03/17/2021
Onset Date: 03/19/2021
Rec V Date: 08/03/2021
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: Irregular heartbeat, resting heart rate at least 20 bpm higher than normal; Severe fluctuations in oxygen levels, feeling out of breath and unable to take a deep breath in; Severe fluctuations in oxygen levels, feeling out of breath and unable to take a deep breath in; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: El3302), dose 1 via an unspecified route of administration, administered in arm left on 17Mar2021 at 10:00 as (at the age of 33-years-old) single for COVID-19 immunisation. Medical history included rheumatoid arthritis and known allergies: coconut. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 19Mar2021 at 08:00, the patient experienced irregular heartbeat, resting heart rate at least 20 bpm higher than normal and severe fluctuations in oxygen levels, feeling out of breath and unable to take a deep breath in. The patient did not receive any treatment for the events. The patient assessed the events as non-serious. The outcome of all the events was resolved. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1522066
Sex: F
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 08/03/2021
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: itchy hives; feeling hot; This is a spontaneous report from a contactable consumer or other non-health care professional. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: 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. The patient experienced itchy hives and feeling hot on an unspecified date. The outcome of the events was unknown. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1522067
Sex: F
Age:
State: PA

Vax Date: 03/03/2021
Onset Date: 03/10/2021
Rec V Date: 08/03/2021
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: Dizziness; Palpitations; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 03Mar2021 11:30 (at the age of 77-years-old) as dose 1, single for COVID-19 immunisation. Medical history included breast cancer from Aug2019 to an unknown date (Has had a Mastectomy, she doesn't know if the cancer is still there or not), Microbacterial infection in the lungs from Sep2018 and ongoing. Concomitant medications included alprazolam (XANAX) taken for anxiety from Jun2020 and ongoing; omeprazole (PROTONIX [OMEPRAZOLE]) taken as her stomach is a huge problem for her (Stomach Acid) and ongoing. The patient asked if she could get her second scheduled vaccine while having symptoms of palpitations and dizziness. She stated she has had palpitations before but these palpitations after the vaccine started on 10Mar2021 (7 days after receiving vaccine). She said she had been a little bit dizzy since her shot but a little bit more today. She had her first shot on 03Mar2021 and her second is scheduled for 24Mar2021. She would like to change her appointment for her second dose and see how she feels. She clarified the dizziness started yesterday and she does not think it's getting worse. Caller stated she had an ultrasound in Jul2020. She had treatment for palpitations prior but confirms she has not had treatment for the palpitations she experienced after the vaccine. Additional vaccines were not administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks) were taken. The adverse events did not required visit to emergency room nor physician office. The outcome of the events was not recovered. No follow-up attempts are Possible. No further information is expected.

Other Meds: XANAX; PROTONIX [OMEPRAZOLE]

Current Illness: Lung infection

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm