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From the 11/12/2021 release of VAERS data:

Found 875,292 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 496 out of 8,753

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VAERS ID: 1841747 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dermatitis bullous, Loss of consciousness, Muscle spasms, Rash, Skin burning sensation, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLINA [FOLIC ACID]; POTASSIUM; MAGNESIUM [MAGNESIUM CARBONATE]; AULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Serum homocysteine increased
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101405721

Write-up: after the second day tachycardia; bullous rash on the face; muscle cramps; extreme weakness; unbearable skin burning; bullous rash on the face; after 5 minutes from Pfizer loss of consciousness; fainting; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number IT-MINISAL02-799712. A 30-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FF4213), dose 1 via intramuscular on 16Sep2021 as dose 1, single for COVID-19 immunisation. Medical history included serum homocysteine increased. Concomitant medications included folic acid (Folina) taken for blood homocysteine increased; potassium; magnesium carbonate and nimesulide (Aulin). On 16Sep2021, the patient experienced loss of consciousness after 5 minutes from pfizer, fainting. On 17Sep2021, the patient experienced after the second day tachycardia, bullous rash on the face, muscle cramps, extreme weakness and unbearable skin burning. Fainting resulted to emergency room visit. Impact on quality of life (10/10). The clinical outcome of all the events was reported as not recovered. Sender comment: 11Oct2021 Local Pharmacovigilance Manager: requesting further information from the reporter such as time of vaccination, clinical development, any medications and/or supplements taken. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Nessuna.


VAERS ID: 1842124 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-09-16
   Days after vaccination:132
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive; Result Unstructured Data: Positive.
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: Vaccination failure; SARS-CoV-2 infection; This case was received via Regulatory Agency (Reference number: AT-BASGAGES-2021-050271) on 27-Oct-2021 and was forwarded to Moderna on 27-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) in a 38-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3002339 and 3001531) for COVID-19 vaccination. No Medical History information was reported. On 07-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant) and COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant). At the time of the report, VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant and Treatment medication were reported. Company comment: This case concerns a 38-year-old, female patient with no relevant medical history, who experienced the unexpected event of COVID-19 and vaccination failure. The events occurred approximately 3 months after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Translation received on 28-OCT-2021 contains translated Dosage text information.; Sender''s Comments: This case concerns a 38-year-old, female patient with no relevant medical history, who experienced the unexpected event of COVID-19 and vaccination failure. The events occurred approximately 3 months after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1842492 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-09-16
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Lymphadenitis, Malaise, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20213

Write-up: Fainting with loss of consciousness; Lymphadenitis; Dizziness; Malaise; Chronic fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting with loss of consciousness), LYMPHADENITIS (Lymphadenitis), DIZZINESS (Dizziness), MALAISE (Malaise) and FATIGUE (Chronic fatigue) in a 39-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3004219) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced SYNCOPE (Fainting with loss of consciousness) (seriousness criteria hospitalization and medically significant), LYMPHADENITIS (Lymphadenitis) (seriousness criteria hospitalization and medically significant), DIZZINESS (Dizziness) (seriousness criteria hospitalization and medically significant), MALAISE (Malaise) (seriousness criteria hospitalization and medically significant) and FATIGUE (Chronic fatigue) (seriousness criteria hospitalization and medically significant). In September 2021, LYMPHADENITIS (Lymphadenitis) had resolved. On 16-Sep-2021, SYNCOPE (Fainting with loss of consciousness) had resolved. At the time of the report, DIZZINESS (Dizziness) and FATIGUE (Chronic fatigue) had not resolved and MALAISE (Malaise) outcome was unknown. No concomitant medications reported by reporter. No treatment medications provided by the reporter. Company comment: This case concerns a 39-year-old female patient with no relevant medical history, who experienced the serious unexpected events of Syncope, Lymphadenitis, Dizziness, Malaise and Fatigue. The events occurred approximately 1 day after the second dose of mRNA-1273. The rechallenge information is not applicable as the event occurred after the second dose. The benefit-risk relationship of the mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report. Based on medical judgment the event of Inappropriate schedule of product administration is relevant because the interval between doses 1 and 2 is 21 days. Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Translation received on 28-OCT-2021 for event, dosage text, sender''s comments, reporter''s comments and case summery.; Reporter''s Comments: Malaise, fainting with loss of consciousness, swollen lymph nodes, persistent fatigue.; Sender''s Comments: This case concerns a 39-year-old female patient with no relevant medical history, who experienced the serious unexpected events of Syncope, Lymphadenitis, Dizziness, Malaise and Fatigue. The events occurred approximately 1 day after the second dose of mRNA-1273. The rechallenge information is not applicable as the event occurred after the second dose. The benefit-risk relationship of the mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report. Based on medical judgment the event of Inappropriate schedule of product administration is relevant because the interval between doses 1 and 2 is 21 days.


VAERS ID: 1842673 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-09-16
   Days after vaccination:224
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No
CDC Split Type: ATPFIZER INC202101413881

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [AT-BASGAGES-2021-050184]. A 34-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 04Feb2021 (Lot Number: EJ6796) as dose 2, single and dose 1 intramuscular on 14Jan2021 (Lot Number: EJ6796) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. On 16Sep2021 the patient experienced SARS-CoV-2 infection and Vaccination failure. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Sep2021 (Variant PCR-based: B.1.617.2, Sequenced variant: n501y-positive: No). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1842674 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-09-16
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: not reported n501y-positive: No.
CDC Split Type: ATPFIZER INC202101413938

Write-up: Vaccination failure/Variant PCR-based: B.1.617.2; SARS-CoV-2 infection/Variant PCR-based: B.1.617.2; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050191. A 50-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular on 01Apr2021 (Batch/Lot Number: ET7205) as dose 1, single, and intramuscular on 22Apr2021 (Batch/Lot Number: EW4815) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection, other, vaccination failure. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive (Variant PCR-based: B.1.617.2; Sequenced variant: not reported; n501y-positive: No) on 16Sep2021. The outcome of the events was unknown. The report was reported as serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1842675 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-09-16
   Days after vaccination:75
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: PCR-based variant: B.1.617.2 n501y-positive: No
CDC Split Type: ATPFIZER INC202101413962

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority WEB. Regulatory authority report number: AT-BASGAGES-2021-050192. A 28-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 03Jul2021 (Batch/Lot Number: FD4555) as dose 2, single, and dose 1 intramuscular on 29May2021 (Batch/Lot Number: FC2473) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Sep2021, the patient experienced sars-cov-2 infection. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Sep2021 (PCR-based variant: B.1.617.2, Variant Sequenced: n501y-positive: No). Outcome of event was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1842676 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-09-16
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based:not provided Sequenced variant:not provided n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101413987

Write-up: Vaccination failure; SARS-CoV-2 infection, other; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB with regulatory authority number AT-BASGAGES-2021-050194. A 38-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 30Jul2021 (Lot Number: FE6208) as dose 2, single; and dose 1 intramuscular on 25Jun2021 (Lot Number: FD0168) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Sep2021, the patient experienced vaccination failure and sars-cov-2 infection, other. The patient underwent lab tests and procedures which included COVID-19 PCR test was positive with variant PCR-based and sequenced variant were not provided, and n501y-positive was unknown on 16Sep2021. The outcome of the events was unknown. No follow-up activities possible. No further information expected.


VAERS ID: 1842677 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-09-16
   Days after vaccination:126
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7015 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based and Sequenced: not reported; n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101414001

Write-up: Vaccination failure; SARS-CoV-2 infection/positive COVID-19 PCR test; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-050195. A 53-year-old male patient received bnt162b2 (COMIRNATY), on 22Apr2021 (Batch/Lot Number: EW4815) as DOSE 1, SINGLE then on 13May2021 (Batch/Lot Number: EY7015) as DOSE 2, SINGLE, both given intramuscularly for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had vaccination failure as the patient had SARS-COV-2 infection on 16Sep2021. The patient had positive COVID-19 PCR test (variant PCR-based and Sequenced: not reported; N501y-positive: Unknown) on that same day of 16Sep2021. Outcome of the events were unknown. No follow-up attempts are possible. No further information is expected


VAERS ID: 1842678 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-09-16
   Days after vaccination:81
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y positive: No
CDC Split Type: ATPFIZER INC202101414044

Write-up: SARS-CoV-2 infection, other, Vaccination failure; SARS-CoV-2 infection, other, Vaccination failure/ Variant PCR-based: B.1.617.2; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-050199. This is the first of two reports. A 60-year-old female patient received the second dose of BNT162B2 (COMIRNATY), intramuscular on 27Jun2021 (Batch/Lot Number: FD6840) as DOSE 2, SINGLE, and the first dose of BNT162B2 intramuscular on 16May2021 (Batch/Lot Number: FA4598) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection, other, vaccination failure (medically significant). The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Sep2021 Variant PCR-based: B.1.617.2 Variant Sequenced: n501y positive: No. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101433466 the same patient, Inappropriate schedule of 2nd dose of vaccine administered


VAERS ID: 1842679 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-09-16
   Days after vaccination:172
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2, sequenced variant: not n501y-positive
CDC Split Type: ATPFIZER INC202101414269

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is AT-BASGAGES-2021-050201. A 49-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, on 07Mar2021 (Lot Number: EP2166), as dose 1, single, and then on 28Mar2021 (Lot Number: ET7205), as dose 2, single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 16Sep2021, the patient experienced SARS-CoV-2 infection, other, and vaccination failure with positive COVID-19 PCR test, variant PCR-based: B.1.617.2, sequenced variant: not n501y-positive. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1842680 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-09-16
   Days after vaccination:97
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20210916; Test Name: COVID-19 Variant PCR-based (B.1.617) n501y positive; Test Result: Negative
CDC Split Type: ATPFIZER INC202101414430

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [AT-BASGAGES-2021-050204]. A 36-year-old male patient received BNT162B2 (COMIRNATY solution for injection), first dose on 30Apr2021 (lot number: EY3014) at dose 1, single, then second dose on 11Jun2021 (lot number: FD0168) at dose 2, single; both via intramuscular at an unspecified age for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Sep2021, the patient experienced vaccination failure and SARS-CoV-2 infection. The patient underwent lab tests and procedures which included: COVID-19 PCR test on 16Sep2021: positive, and COVID-19 Variant PCR-based (B.1.617) n501y positive on 16Sep2021: negative. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1842681 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-09-16
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD 6840 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617 not differentiated Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101414444

Write-up: Vaccination failure/Variant PCR-based: B.1.617 not differentiated. Sequenced variant: n501y-positive: No.; SARS-CoV-2 infection/Variant PCR-based: B.1.617 not differentiated. Sequenced variant: n501y-positive: No.; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050205. This physician reported different events for both doses of Comirnaty for the same patient. This is the first of two reports. Only this case is serious. A 35-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 30Jun2021 (Batch/Lot Number: FD 6840) as dose 2, single, and intramuscular on 19May2021 (Batch/Lot Number: FA4598) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Sep2021, the patient experienced vaccination failure (as reported) and SARS-CoV-2 infection with variant PCR-based: B.1.617 not differentiated. Sequenced variant: n501y-positive: No. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Sep2021 (Variant PCR-based: B.1.617 not differentiated Sequenced variant: n501y-positive: No). Outcome of the events was unknown. No follow up attempts are needed. No further information is expected.


VAERS ID: 1842684 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-09-16
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: Variant PCR-based; Result Unstructured Data: Test Result:Sequenced variant: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101413918

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number is AT-BASGAGES-2021-050216. An 89-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection), intramuscular on 30Mar2021 (Batch/Lot Number: ET7205) as dose 2, single; and intramuscular on 10Mar2021 (Batch/Lot Number: ET1831) as dose 1, single both for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Spe2021, the patient experienced vaccination failure and SARS-CoV-2 infection. The patient underwent lab tests and procedures which included variant PCR-based: sequenced variant: n501y-positive: unknown on 16Sep2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1842686 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-09-16
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2, sequenced variant: not n501y-positive
CDC Split Type: ATPFIZER INC202101414471

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is AT-BASGAGES-2021-050218. A 32-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, on 17Jun2021 (Lot Number: FD1921), as dose 1, single, and then on 15Jul2021 (Lot Number: FE6208), as dose 2, single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 16Sep2021, the patient experienced SARS-CoV-2 infection, other, and vaccination failure with positive COVID-19 PCR test, variant PCR-based: B.1.617.2, sequenced variant: not n501y-positive. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1842687 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-09-16
   Days after vaccination:105
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101414482

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority WEB [AT-BASGAGES-2021-050220]. A 61-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 03Jun2021 (Lot Number: FD1921) as dose 2, single and dose 1 intramuscular on 27Apr2021 (Lot Number: EW2239) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection and Vaccination failure. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Sep2021 (Variant PCR-based: B.1.617.2, Variant Sequenced: n501y-positive: No). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1842689 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-09-16
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2; Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101414489

Write-up: Vaccination failure; SARS-CoV-2 infection/positive COVID-19 PCR test (PCR-based variant: B.1.617.2 Variant Sequenced: n501y-positive: No); This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-050222. A 54-year-old male patient received bnt162b2 (COMIRNATY), on 06May2021 (Batch/Lot Number: EY7015) as DOSE 1, single then on 16Jun2021 (Batch/Lot Number: FD0168) as DOSE 2, single both given intramuscularly for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had vaccination failure as the patient had SARS-COV-2 infection on 16Sep2021. The patient had positive COVID-19 PCR test (PCR-based variant: B.1.617.2; Variant Sequenced: n501y-positive: No) on that same day of 16Sep2021. Outcome of the events were unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1842691 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-09-16
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Variant Sequenced: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101414510

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-050224. A 28-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 18Aug2021 (Batch/Lot Number: FE6208) as a single dose and dose 1 intramuscular on 19Jul2021 (Batch/Lot Number: FE6208) as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 16Sep2021, the patient experienced SARS-CoV-2 infection, other, Vaccination failure. The patient underwent sars-cov-2 test: positive, variant PCR-based:, variant sequenced: n501y-positive: unknown on 16Sep2021. Outcome of the events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1842692 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-09-16
   Days after vaccination:98
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2, sequenced variant: not reported, n501y-positive: no
CDC Split Type: ATPFIZER INC202101414515

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, Regulatory Authority number: AT-BASGAGES-2021-050226. A 60-year-old female patient received two doses of BNT162B2 (COMIRNATY), the first dose on 30Apr2021 (Lot. EY3014) and the second dose on 10Jun2021 (Lot. FD1921) intramuscular, both at single dose, for COVID-19 immunisation. Relevant medical history, concurrent conditions and concomitant medications were unknown. The patient''s weight was not reported, and height was not reported. The patient experienced SARS-CoV-2 infection, vaccination failure on 16Sep2021. The events were serious as medically significant with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Sep2021. Variant PCR-based: B.1.617.2, sequenced variant: not reported, n501y-positive: no. No follow-up attempts possible. No further information expected.


VAERS ID: 1842694 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-09-16
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2; Sequenced variant: unknown; and n501y-positive: No
CDC Split Type: ATPFIZER INC202101414526

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician, downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is AT-BASGAGES-2021-050228. A 37-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), intramuscularly on 14Mar2021 (Batch/Lot Number: ET1831, Expiration date: unknown) as dose 1, single, and then intramuscularly on 10Apr2021 (Batch/Lot Number: EW2239, Expiration date: unknown) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 16Sep2021, the patient experienced vaccination failure, SARS-CoV-2 infection. This report was considered serious - medically significant. The patient underwent lab test and procedure, which included COVID-19 polymerase chain reaction (PCR) test: positive on 16Sep2021 with variant PCR-based: B.1.617.2; sequenced variant: unknown; and n501y-positive: no. The outcome of vaccination failure, SARS-CoV-2 infection was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1842695 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-09-16
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101414533

Write-up: SARS-CoV-2 infection/ n501y-positive: Unknown; Vaccination failure/ n501y-positive: Unknown; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050229. A 39-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 05Aug2021 (Lot Number: FE6208) as dose 2, single and intramuscular on 09Jul2021 (Lot Number: FD6840) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection, other, Vaccination failure. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Sep2021 (n501y-positive: Unknown). Outcome of the event was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1842696 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-09-16
   Days after vaccination:176
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101414172

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number AT-BASGAGES-2021-050231. An 84-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 24Mar2021 (Batch/Lot Number: ET3620) as DOSE 2, SINGLE and dose 1 intramuscular on 03Mar2021 (Batch/Lot Number: EJ6790) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 16Sep2021 the patient experienced SARS-CoV-2 infection, other, Vaccination failure. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Sep2021 (Variant PCR-based: B.1.617.2; Sequenced variant: n501y-positive: No). The outcome of the events was unknown. English summary (full translation available upon request). No follow-up activities possible. No further information expected.


VAERS ID: 1842697 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-09-16
   Days after vaccination:139
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3014 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No
CDC Split Type: ATPFIZER INC202101414166

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is AT-BASGAGES-2021-050232. A 65-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 30Apr2021 (Batch/Lot Number: EY3014) as dose 2, single, dose 1 intramuscular on 09Apr2021 (Batch/Lot Number: EW2239) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sars-cov-2 infection, vaccination failure on 16Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Sep2021 Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1842700 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-09-16
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617 not differentiated Variant Sequenced: n501y, positive: No
CDC Split Type: ATPFIZER INC202101413930

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB AT-BASGAGES-2021-050239. A 58-year-old male patient received bnt162b2 (COMIRNATY) intramuscularly on 16Jul2021 (Batch/Lot Number: FE6208) as dose 2, single and intramuscularly on 11Jun2021 (Batch/Lot Number: FD1921) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced SARS-CoV-2 infection and vaccination failure on 16Sep2021. The patient underwent lab tests and procedures which included COVID-19 PCR test (16Sep2021): Positive (Variant PCR-based: B.1.617 not differentiated Variant Sequenced: n501y, positive: No). Outcome of events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1842701 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-09-16
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617 not differentiated Sequenced variant: n501y-positive: No
CDC Split Type: ATPFIZER INC202101413939

Write-up: Vaccination failure/Variant PCR-based: B.1.617 not differentiated Sequenced variant: n501y-positive: No; SARS-CoV-2 infection/Variant PCR-based: B.1.617 not differentiated Sequenced variant: n501y-positive: No; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050241. A 46-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 23Jun2021 (Batch/Lot Number: FD4555) as dose 2, single, and intramuscular on 19May2021 (Batch/Lot Number: FA4598) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Sep2021, the patient experienced vaccination failure and SARS-CoV-2 infection with Variant PCR-based: B.1.617 not differentiated Sequenced variant: n501y-positive: No. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Sep2021 (Variant PCR-based: B.1.617 not differentiated Sequenced variant: n501y-positive: No). Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1842703 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-09-16
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based, Sequenced variant, n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101414234

Write-up: vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is AT-BASGAGES-2021-050253. A 17-year-old female patient received BNT162B2 (COMIRNATY solution for injection), first dose on 17Jun2021 (lot number: FD0168) at dose 1, single, then second dose on 29Jul2021 (lot number: FF0680) at dose 2, single; both via intramuscular at an unspecified age for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Sep2021, the patient experienced vaccination failure and SARS-CoV-2 infection. The patient underwent COVID-19 PCR test on 16Sep2021 with result: positive (variant PCR-based, Sequenced variant, n501y-positive: Unknown). Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1842704 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-09-16
   Days after vaccination:111
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002188 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: Vaccination failure; SARS-CoV-2 infection; This case was received via Agency Regulatory Authority (Reference number: AT-BASGAGES-2021-050292) on 27-Oct-2021 and was forwarded to Moderna on 27-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) in a 54-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3002920 and 3002188) for COVID-19 vaccination. No Medical History information was reported. On 28-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant) and COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant). At the time of the report, VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter. Treatment information was not provided. Company comment: This case concerns a 54-year-old, male patient with no relevant medical history, who experienced the serious adverse event of special interest of COVID-19 and serious adverse event of vaccination failure. The events occurred approximately 2 months and 14 days after the second dose of Moderna COVID-19 vaccine. The rechallenge was assessed as not applicable as the AEs occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Translation received on 26-Oct-2021 contains updated dosage text.; Sender''s Comments: This case concerns a 54-year-old, male patient with no relevant medical history, who experienced the serious adverse event of special interest of COVID-19 and serious adverse event of vaccination failure. The events occurred approximately 2 months and 14 days after the second dose of Moderna COVID-19 vaccine. The rechallenge was assessed as not applicable as the AEs occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1842721 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-09-16
   Days after vaccination:104
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: variant PCR-based: B.1.617.2; sequenced variant: n501y-positive: no
CDC Split Type: ATPFIZER INC202101414349

Write-up: Vaccination failure/SARS-CoV-2 infection; Vaccination failure/SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-050628. A 31-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), intramuscularly on 04Jun2021 (lot number: FD1921) as dose 2, single and intramuscularly on 03May2021 (lot number: EY3014) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure/ SARS-CoV-2 infection on 16Sep2021. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive (variant PCR-based: B.1.617.2; sequenced variant: n501y-positive: no) on 16Sep2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1844066 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Deafness neurosensory, Headache, Pyrexia, Tinnitus
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hearing impairment (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AERIUS [DESLORATADINE]; TAMOXIFEN; TRAMAL; TOPAMAX
Current Illness: Allergic asthma; Breast carcinoma; Retinal damage NOS (bilateral retinal lesions)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101442400

Write-up: right sensorineural sudden deafness; sudden ringing in the right ear; Fever; Severe headache for days; This is a spontaneous report received from a contactable Consumer or other non professional via Regulatory Authority. Regulatory authority report number CH-SM-2021-25791. A 51-year-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Right on 16Sep2021 (Batch/Lot Number: FD0350) at the age of 51-year-old, as dose 2, single for covid-19 immunisation. Medical history included ongoing retinal injury (bilateral retinal lesions), ongoing asthma, ongoing breast cancer. Historical vaccine included the first dose of Comirnaty on 26Aug2021 for covid-19 immunisation. Concomitant medications included desloratadine (AERIUS) taken for an unspecified indication, start and stop date were not reported; tamoxifen taken for an unspecified indication, start and stop date were not reported; tramadol hydrochloride (TRAMAL) taken for an unspecified indication, start and stop date were not reported; topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported. The patient experienced right sensorineural sudden deafness on 23Sep2021 with outcome of not recovered, fever on 16Sep2021 with outcome of recovered on 19Sep2021, severe headache for days on 16Sep2021 with outcome of recovered on 23Sep2021, sudden ringing in the right ear on 23Sep2021 with outcome of recovered on 23Sep2021. Following the second dose of the vaccine, she experiences high fever for three days and persistent (fixed) headache starting in the back area then radiating to the upper part up to the right ear until 23Sep2021, when the patient reports the appearance of a sudden whistle at the right ear resulting in deafness. The patient then contacts an ENT (otolaryngology) to whom she goes on 24Sep2021, who diagnoses sudden right sensorineural deafness. Cortisone treatment is prescribed. At the time of reporting, 24Sep2021, deafness was still present. Reporter comment: Sudden right sensorineural deafness Sender comment: Sudden right sensorineural deafness, tinnitus, fever and headache appeared in temporal correlation with the second dose of Comirnaty vaccine. Fever and headache are known adverse reactions for Comirnaty, reported in the product monograph as very frequent. They usually arise rapidly and last for a few days (1-3 days, Uptodate). The persistence of the headache (fixed / uninterrupted) for a week and its extent is singular in the case reported here. In the light of some literature data and considering the plausible temporal correlation, but not being able to exclude other possible causes, the judgment of causality is considered possible for sudden sensorineural deafness and tinnitus. Likely for fever and headache being well known adverse reactions and given the close temporal correlation. A causal relationship between COMIRNATY and Deafness neurosensory, Tinnitus was assessed as being Possible. A causal relationship between COMIRNATY and Fever, Headache was assessed as being Probable/Likely. This case was reported as serious Other medically important condition. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Sudden right sensorineural deafness


VAERS ID: 1844085 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Migraine, Migraine with aura, Parosmia, Photophobia
SMQs:, Taste and smell disorders (narrow), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101432150

Write-up: Migraine headache; Migraine aura; Headache; Hypersensitivity to light (strong) and smells.; Hypersensitivity to light (strong) and smells.; This is a spontaneous report received from a contactable consumer via regulatory authority. Regulatory authority report number CH-SM-2021-26588. A 52-year-old female patient received BNT162B2 (COMIRNATY; lot number FD0350), via an unspecified route of administration, on 14Sep2021, at the age of 52 years, as the first single dose, for COVID-19 immunization. Medical history included migraine. Concomitant medications were not reported. The patient experienced migraine headache, migraine aura, headache and hypersensitivity to light (strong) and smells, all on 16Sep2021 with outcome of recovered on 23Sep2021. Comirnaty last administration: 18Oct2021 (batch/lot no: FD0350). Sender''s comments: The case was serious and unlabelled. Due to temporal relationship and the known safety profile of the vaccine the causality was assessed as possible. A causal relationship between Comirnaty and hypersensitivity, headache, migraine aura, migraine headache was assessed as being possible. This case was reported as serious (Other medically important condition). No follow-up attempts possible. No further information expected.


VAERS ID: 1844090 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Hypoaesthesia, Paralysis
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101434672

Write-up: Headache; Fatigue extreme; Palsy; Hypoaesthesia; This is a spontaneous report received from a contactable consumer (patient) via the regulatory authority, regulatory authority report number CH-SM-2021-26846. A 41-year-old female patient received BNT162B2 (COMIRNATY), unknown dose number via an unspecified route of administration on 16Sep2021 (Batch/Lot Number: FF0688, age 41-year-old at vaccination) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 16Sep2021 (on the same day of vaccination) the patient experienced hypaesthesia and palsy described as numbness and paralysis on the left little finger. On 17Sep2021 (the next morning ), the patient experienced numbness and paralysis on both little fingers (this was fine for six days afterwards). On 18Sep2021 the patient experienced headache and extreme fatigue described as latent light headaches and extreme tiredness. It was reported that even if she slept during the day, she was just as tired in the evening as if she had worked and not slept. This case was reported as serious medically important condition. A causal relationship between BNT162B2 and the events was reported as being possible. The outcome of the events hypaesthesia, palsy, headache and extreme fatigue was reported as "not recovered", however stop date was reported as "22Sep2021". No follow-up attempts possible. No further information expected.; Reporter''s Comments: The case is serious and unlabelled. Due to temporal relationship and the known safety profile of the vaccine the causality is assessed as possible.


VAERS ID: 1844486 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Bone metastases ((under chemotherapy)); Breast cancer ((Right)); COPD (post smoking); Smoker ((40 packs/year, still active))
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer ((Left))
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: positive for COVID-19; Test Result: Positive
CDC Split Type: FRPFIZER INC202101414980

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MP20217953. A 56-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 19Apr2021 (Batch/Lot Number: EX0893) as dose 2, single, and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included ongoing bone metastases (under chemotherapy), ongoing chronic obstructive pulmonary disease (COPD) post-smoking, breast cancer from 2013 to an unknown date (left), and breast cancer from 2015 and ongoing (right), and smoking from 1980 and ongoing (40 packs/year, still active). The patient was under unspecified breast cancer chemotherapy treatment. No details of current or recent treatment changing immunity status. On 16Sep2021, the patient experienced vaccination failure (as reported) and COVID-19 (positive for COVID-19). The patient was hospitalized due to the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 16Sep2021. The patient recovered from the events on an unspecified date. No follow-up attempts are possible; information about lot/batch number of first dose cannot be obtained. No further information is expected.


VAERS ID: 1844597 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Pain, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101426645

Write-up: Pain; Felt like my centre of the chest was a scar and that I couldn''t move it as it was tight; Heart palpitations; Shortness of breath; This is a spontaneous report from a contactable consumer (patient) received from The regulatory authority report number is GB-MHRA-EYC 00264113, Safety Report Unique Identifier GB-MHRA-ADR 26103932. A 24-year-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF2153), via an parenteral on 15Sep2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced heart palpitations on 16Sep2021, shortness of breath on 16Sep2021, pain on an unspecified date, felt like her centre of the chest was a scar and that the patient couldn''t move it as it was tight on an unspecified date. The patient brother also experienced same affects and diagnosed with pericarditis by cardiologist. The patient currently waiting to see cardiologist herself. The patient felt like my centre of the chest was a scar and that I couldn''t move it as it was tight. Felt like someone was standing on my chest and that if breathe in had pain, her lung and heart were colliding or there wasn''t enough space for them both. The patient was taking Pfizer COVID 19 vaccine for: COVID-19 vaccination. The event were eventually medically significant. The outcome of the event was recovering for Shortness of breath, not recovered for Palpitations, unknown for Chest tightness, Pain. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1844902 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abdominal pain upper, Chest pain, Fatigue, Heart rate, Heart rate increased, Inappropriate schedule of product administration, Investigation, Menstruation irregular, Migraine, Palpitations, Pyrexia, SARS-CoV-2 test, Tachycardia, Vulvovaginal discomfort
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Fertility disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heartburn (lower oesophageal sphincter weak); Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''''s disease, ulcerative colitis)); Oesophageal scarring; Proctitis; Scarring
Allergies:
Diagnostic Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:Raised; Test Name: Investigation; Result Unstructured Data: Test Result:All test for common vaginal issues have come back; Comments: All test for common vaginal issues have come back negative or normal.; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101433226

Write-up: Migraine; Stomach ache; Heart rate raised; Irregular periods; Inappropriate schedule of vaccine administered; extremely painful abdomen; Fatigue/unusual tiredness; Chest pain; Fever; Heart palpitations; Racing heart (tachycardia); Changes in vagina which can''t be explained by any tests the doctors have done; This is a spontaneous report from a contactable consumer. This is the second of 2 cases reports. The first report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110191039211950-PABRM, Safety Report Unique Identifier is GB-MHRA-ADR 26091594. A 37-year-old female patient had received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Lot Number: FF2153), DOSE 2, SINGLE via an unspecified route of administration on 16Sep2021 at dose 2 (At the age of vaccination 37 Years old), single for COVID-19 immunization which was inappropriate schedule of vaccine administered. Medical history included dyspepsia from an unknown date and unknown if ongoing lower oesophageal sphincter weak, proctitis from an unknown date and unknown if ongoing, scar from an unknown date and unknown if ongoing, inflammatory bowel disease from an unknown date and unknown if ongoing Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis), oesophageal stenosis from an unknown date and unknown if ongoing. Concomitant medication was taken. Patient has not had symptoms associated with COVID-19. Historical Vaccine: BNT162B2 taken on 21Jul2021 at age of 37 Years old for COVID-19 immunization, Dose 1, Lot number- FD 8813. Events Verbatim extremely painful abdomen, Vaginal pain, Fatigue/unusual tiredness, Chest pain, Fever, Heart palpitations, racing heart (tachycardia), Changes in vagina which can''t be explained by any tests the doctors have done were occurred. Results of tests and procedures for investigation of the patient: All test for common vaginal issues have come back negative or normal. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On unknown date in 2021, the patient had experienced extremely painful abdomen, chest pain, fever, racing heart, heart palpitations, changes in vagina which can''t be explained by any tests the doctors have done and fatigue. On 17Sep2021, the patient had experienced migraine, stomachache, heart rate raised, irregular periods. These events were assessed as disability. It was reported that, Fatigue/unusual tiredness, heart palpitations, racing heart (tachycardia), chest pain, fever, irregular periods, migraine, stomachache and vaginal pain. Raised heart rate. Extremely painful abdomen, very odd periods, severe migraines. Lasting 3 days at a time with only small relief in between. Changes in vagina which can''t be explained by any tests the doctors have done. All were still ongoing expected. The patient underwent lab tests and procedures which included investigation: all test for common vaginal issues have come back on an unspecified date All test for common vaginal issues have come back negative or normal, sars-cov-2 test negative on an unspecified date No - Negative COVID-19 test, heart rate: raised on an unspecified date. The report related to possible inflammation of the heart. The symptoms did not lead to a hospital stay. No treatment given because of your symptoms. There were no blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. The clinical outcome of the events abdominal pain, fatigue, chest pain, fever, heart palpitations, racing heart, and remaining events were not resolved. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101418051 Same patient/Drug but different dose/event


VAERS ID: 1845103 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-16
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate decreased, Heart rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: Elevated pulse between 110 and 150 bpm, peaking at over 200 bpm; Reduced pulse to 56 bpm; This case was received via Regulatory Authority (Reference number: NO-NOMAADVRE-E2B_00056376) on 27-Oct-2021 and was forwarded to Moderna on 27-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of in a 30-year-old male patient who received mRNA-1273 (Spikevax) for Vaccination. No Medical History information was reported. On 02-Sep-2021 at 10:30 AM, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medications provided. No treatment medications provided. The patient was in contact with other health care professional. Patient reports about getting a sick leave. Patient reports about high pulse rate between 110 and 150 bpm and peaks above 200 bpm. Patient reports about noticing a resting pulse of 110 bpm which did not get better. Patient decided to go to the out-of-hours emergency centre on 19-Sep-2021, and was sent to the emergency room. Tests were done, and the patient was sent home, asked to stay calm. On 20-Sep-2021, the patient experienced a pulse drop to 56 BPM. The patient laid down in the sofa, and the pulse increased to above 210 bpm. An ambulance was called. Patient reports about not having had high pulse rate before taking the vaccine. Company Comment: This case concerns a 30-year-old, male patient with no relevant medical history, who experienced the unexpected event of heart rate increased. The event heart rate increased occurred 14 days after the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since the only information disclosed was with this unknown dose number. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Translated document received on 29-Oct-2021: Event verbatim was updated.; Sender''s Comments: This case concerns a 30-year-old, male patient with no relevant medical history, who experienced the unexpected event of heart rate increased. The event heart rate increased occurred 14 days after the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since the only information disclosed was with this unknown dose number. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1845811 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-09-16
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Variant PCR-based: Variant Sequenced: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101435893

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number AT-BASGAGES-2021-050255. An 81-year-old female patient received second BNT162B2 (COMIRNATY, formulation: solution for injection, lot number: EW2239) via an intramuscular route of administration on 10Apr2021 as DOSE 2, SINGLE and received first dose of BNT162B2 (COMIRNATY, formulation: solution for injection, lot number: ET1831), via an intramuscular route of administration on 20Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Sep2021, the patient experienced vaccination failure and SARS-COV-2 infection. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive (Variant PCR-based: Variant Sequenced: n501y-positive: Unknown) on 16Sep2021. The seriousness of the events was serious and medically significant. The outcome of the events was unknown. No follow-up attempts possible. No further information was expected.


VAERS ID: 1845861 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-09-16
   Days after vaccination:210
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: COVID-19 PCR test Positive
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: Vaccination failure; SARS-CoV-2 infection; This case was received via regulatory authority(Reference number: AT-BASGAGES-2021-058783) on 28-Oct-2021 and was forwarded to Moderna on 28-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) in a 90-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. G26761A and G26761A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion hospitalization) and COVID-19 (SARS-CoV-2 infection) (seriousness criterion hospitalization). At the time of the report, VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, SARS-CoV-2 test: positive (Positive) COVID-19 PCR test Positive. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided by reporter. No treatment drug was provided by reporter. Company comment- This case concerns a 90-year-old, male patient with no relevant medical history, who experienced the unexpected event of COVID-19 and vaccination failure. The events, which resulted in hospitalization, occurred almost 6 months after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The patient''s age remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Translation document received on 28-OCT-2021, Dosage text was updated to English.; Sender''s Comments: This case concerns a 90-year-old, male patient with no relevant medical history, who experienced the unexpected event of COVID-19 and vaccination failure. The events, which resulted in hospitalization, occurred almost 6 months after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The patient''s age remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1847831 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-16
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2018 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Facial paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: Test Result:36 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101430870

Write-up: left facial palsy/Ordinary facial palsy; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21129902. The patient was a 52-year and 1-month-old female. Body tempera before vaccination was 36 Centigrade. There were no points provided on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status, etc.). On an unspecified date, the patient received the first dose of bnt162b2 (Comirnaty, Lot number FF3620, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 07Sep2021 at 09:20 (the day of the vaccination), the patient received the second dose of bnt162b2 (Comirnaty, Lot number FF2018, Expiration date 31Dec2021) via an unspecified route of administration as a single dose for COVID-19 immunization.Age at vaccination 52 years. On 16Sep2021 at 12:00 (9 days after the vaccination), the patient experienced Left facial palsy. On 23Oct2021 (46 days after the vaccination), the outcome of events was recovered. The reporter classified the event as non-serious and assessed the causality between the event and the vaccines as unassessable. Other possible cause of the event such as any other diseases was: Ordinary facial palsy was possible. The course of the event was as follows: On 16Sep2021, the patient experienced left facial palsy, which tended to subside owing to administration of PREDONINE 30mg while tapering its dose. On 23Oct2021, the symptom resolved. The reporter commented as follows: The symptom has been reported abroad.The causal relation was not clear.


VAERS ID: 1847901 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2835 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amenorrhoea, Body temperature, Hyperpyrexia, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210917; Test Name: hyperpyrexia; Result Unstructured Data: Test Result:40.5 to 42 Centigrade
CDC Split Type: NLPFIZER INC202101419926

Write-up: Fever: 40.5 to 42 degrees Celsius,; Nausea; Menstruation does not occur after vaccination; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00695353. A 17-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 16Sep2021 (Batch/Lot Number: FF2835) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 17Sep2021, the patient experienced menstruation does not occur after vaccination (1 hr after start), fever: 40.5 to 42 degrees Celsius (20 hours after start) (medically significant), nausea (20 hours after start). The patient underwent lab tests and procedures which included body temperature: 40.5 to 42 centigrade on 17Sep2021. The outcome of the event Fever: 40.5 to 42 degrees Celsius, was recovered on 19Sep2021, event Nausea was recovered on 18Sep2021, while not recovered for the event Menstruation does not occur after vaccination. The patient did not have previous COVID-19 infection. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1850201 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-09-16
   Days after vaccination:83
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Variant Sequenced: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101437245

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-050256. A 38-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 25Jun2021 (Batch/Lot Number: FD4555) as DOSE 2, SINGLE, dose 1 intramuscular on 04Jun2021 (Batch/Lot Number: FC2473) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced vaccination failure and sars-cov-2 infection on 16Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Sep2021 (Variant PCR-based: Variant Sequenced: n501y-positive: Unknown). No follow-up attempts possible. No further information expected.


VAERS ID: 1850202 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-09-16
   Days after vaccination:183
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: PCR based variant: Sequenced variant: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101436892

Write-up: COVID-19 confirmed by positive COVID-19 test; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-050257. A 92-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection) intramuscular on 17Mar2021 (Batch/Lot Number: ET1831) as dose 2, single and via intramuscular on 24Feb2021 (Batch/Lot Number: EP2163) as dose 1, single both doses for COVID-19 immunization. There was no relevant medical history and concomitant medications reported for the patient. On 16Sep2021 the patient experienced SARS-CoV-2 infection, other, vaccination failure. Seriousness of the event was medically significant. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Sep2021 (PCR based variant: Sequenced variant: n501y-positive: Unknown). The outcome of the event SARS-CoV-2 infection was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1850203 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-09-16
   Days after vaccination:218
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive; Comments: Variant PCR-based: B.1.617.2 Sequenced variant, n501y-positive: No.
CDC Split Type: ATPFIZER INC202101436900

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician from the Regulatory Authority AT-BASGAGES-2021-050258. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL1491), intramuscular on an 19Jan2021 as dose 1, single and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EJ6136), intramuscular on an 10Feb2021 as dose 2, single for covid-19 immunization. Patient had no known relevant medical history. The patient concomitant medications were not reported. On 16Sep2021, the patient experienced SARS-CoV-2 infection and other, Vaccination failure. On 16Sep2021, the patient underwent lab test SARS-CoV-2 test positive (Variant PCR-based: B.1.617.2, Sequenced variant, n501y-positive: No. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1850204 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-09-16
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: PCR based variant: Sequenced variant: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101436904

Write-up: SARS-CoV-2 infection; drug ineffective; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-050259. Different events after two doses were identified. This is the first of two reports. From this case a split case AER 202101455052 has been created for Inappropriate schedule of vaccine after the second dose. A 16-years-old female patient received second dose of bnt162b2 (Comirnaty, Solution for injection, lot number: FE6208 and expiry date was not reported), via intramuscular route of administration on 23Jul2021, as DOSE 2, SINGLE for COVID-19 immunization. The patient received first dose of bnt162b2 (Comirnaty, Solution for injection, lot number: FD1921 and expiry date was not reported), via intramuscular route of administration, on 11Jun2021, as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection and drug ineffective. On 16Sep2021, the patient underwent lab tests and procedures which included COVID-19 PCR test resulted positive with PCR based variant: sequenced variant, n501y-positive: Unknown. The outcome of event SARS-CoV-2 infection was unknown. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101455052 Same patient, split for Inappropriate schedule of vaccine administered after 2nd dose


VAERS ID: 1850205 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-09-16
   Days after vaccination:218
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Sequenced variant: n501y-positive: Unknown.
CDC Split Type: ATPFIZER INC202101436910

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050261. A 29-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: EK9788) second dose via intramuscular route of administration on 10Feb2021 at dose 2, single and first dose via intramuscular route of administration on 20Jan2021 (Lot Number: EL1491) at dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Sep2021, the patient experienced SARS-CoV-2 infection, Vaccination failure. On 16Sep2021, the patient underwent lab tests and procedures which included SARS-CoV-2 test: positive (Variant PCR-based: Sequenced variant: n501y-positive: Unknown). The clinical outcome of event was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1850208 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-09-16
   Days after vaccination:202
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617 not differentiated Variant Sequenced: n501y positive: No
CDC Split Type: ATPFIZER INC202101437270

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-050270. A 43-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 26Feb2021 (Batch/Lot Number: ET1831) as DOSE 2, SINGLE, dose 1 intramuscular on 28Jan2021 (Batch/Lot Number: EJ6134) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection, other, Vaccination failure. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Sep2021 (Variant PCR-based: B.1.617 not differentiated. Variant Sequenced: n501y positive: No). The outcome of the events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1850209 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-09-16
   Days after vaccination:155
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: Variant PCR-based: B.1.617 not differentiated; Result Unstructured Data: Test Result:Sequenced variant: n501y-positive: No
CDC Split Type: ATPFIZER INC202101437276

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number is AT-BASGAGES-2021-050272. A 82-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection), intramuscular on 14Apr2021 (Batch/Lot Number: EW2246) as dose 2, single; and intramuscular on 17Mar2021 (Batch/Lot Number: ET1831) as dose 1, single both for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Sep2021, the patient experienced SARS-CoV-2 infection, other, vaccination failure. The events were reported as serious. The patient underwent lab tests and procedures which included variant PCR-based: B.1.617 not differentiated: sequenced variant: n501y-positive: no on 16Sep2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1850212 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-09-16
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Sequenced variant: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101437285

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-050276. A 51-year-old female patient received the first dose of bnt162b2 (COMIRNATY) on 16Jun2021 (lot number: FD1921) Intramuscularly at single dose; the second dose of bnt162b2 (COMIRNATY) on 21Jul2021 (lot number: FD0168) Intramuscularly at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection, other, Vaccination failure. Lab data included COVID-19 PCR test on 16Sep2021: positive, Variant PCR-based: Sequenced variant: n501y-positive: Unknown. The outcome of the events was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1850214 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-09-16
   Days after vaccination:105
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: /Variant Sequenced: /n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101435918

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB. The regulatory authority number is AT-BASGAGES-2021-050280. A 68-year-old female patient received BNT162B2 (COMIRNATY Solution for injection), intramuscular, on 03Jun2021 (lot number: FD1921), as dose 2, single; and intramuscular, on 22Apr2021 (lot number: EW4815), as dose 1, single, for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 16Sep2021, the patient experienced drug ineffective (also reported as vaccination failure) and SARS-CoV-2 infection. The patient tested positive for SARS-CoV-2 infection via COVID-19 PCR test on 16Sep2021 (Variant PCR-based: /Variant Sequenced: /n501y-positive: Unknown). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1850217 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-09-16
   Days after vaccination:113
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC0681 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive; Comments: Variant PCR-based: B.1.617 not differentiated, Sequenced variant, n501y-positive: No.
CDC Split Type: ATPFIZER INC202101435897

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number AT-BASGAGES-2021-050284. A 77-year-old female patient received bnt162b2 (COMIRNATY) intramuscularly, dose 1 on 14Apr2021 (Batch/Lot Number: EW2246) as DOSE 1, SINGLE, then dose 2 on 26May2021 (Batch/Lot Number: FC0681) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced drug ineffective (reported as vaccination failure) as the patient had sars-cov-2 infection on 16Sep2021. The patient underwent lab tests and procedures which included COVID-19 PCR test positive on 16Sep2021 (Variant PCR-based: B.1.617 not differentiated, Sequenced variant, n501y-positive: No). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected. Information about batch/lot number already obtained.


VAERS ID: 1850218 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-09-16
   Days after vaccination:106
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617 not differentiated Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101435913

Write-up: drug ineffective; SARS-CoV-2 infection, Variant PCR-based: B.1.617 not differentiated; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050285. This is the first of two reports. A 68-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 02Jun2021 (Batch/Lot Number: FC2473) as dose 2, single, intramuscular on 21Apr2021 (Batch/Lot Number: EW4815) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced drug ineffective/Vaccination failure, sars-cov-2 infection on 16Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Sep2021 (Variant PCR-based: B.1.617 not differentiated, Sequenced variant: n501y-positive: No). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1850219 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-09-16
   Days after vaccination:209
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617 not differentiated Sequenced variant: n501y-positive: No
CDC Split Type: ATPFIZER INC202101435939

Write-up: Vaccination failure/1st dose 29jan2021, second dose 19feb2021.; SARS-CoV-2 infection/Vaccination failure/1st dose 29jan2021, second dose 19feb2021.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-050287. An 81-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 19Feb2021 (Batch/Lot Number: EP2163) as dose 2, single, dose 1 intramuscular on 29Jan2021 (Batch/Lot Number: EJ6136) as dose 1, single for covid-19 immunisation. The patient''s medical history was not reported. There were no concomitant medications. On 16Sep2021 the patient experienced SARS-CoV-2 infection, other, Vaccination failure. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Sep2021, Variant PCR-based: B.1.617 not differentiated.Sequenced variant: n501y-positive: No. The outcome of the events was unknown. No follow-up attempts possible. No further information expected. COMIRNATY batch lot already obtained.


VAERS ID: 1850220 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-09-16
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617 not differentiated Sequenced variant: n501y-positive: No
CDC Split Type: ATPFIZER INC202101436380

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB AT-BASGAGES-2021-050290. A 43-year-old male patient received bnt162b2 (COMIRNATY), first dose on 04Jun2021 (Lot number: FD1921) then second dose on 09Jul2021 (Lot number: FE6208), both via intramuscular at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Sep2021, the patient experienced SARS-CoV-2 infection and vaccination failure. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Sep2021 (Variant PCR-based: B.1.617 not differentiated, Sequenced variant: n501y-positive: No). Outcome of the event was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1850221 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-09-16
   Days after vaccination:104
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: PCR-based variant: B.1.617.2 Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101436370

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050291. A 42-year-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection) intramuscularly on 30Apr2021 (Batch/Lot Number: EX0893) as dose 1, single and second dose intramuscularly on 04Jun2021 (Batch/Lot Number: FC2473) as dose 2, single - both for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection and vaccination failure. Events were assessed as serious, medically significant. The patient underwent lab test which included COVID-19 PCR test: positive (PCR-based variant: B.1.617.2 Variant Sequenced: n501y-positive: No) on 16Sep2021. Outcome of all events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1850224 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-09-16
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Sequenced variant: n501y-positive: Unknown.
CDC Split Type: ATPFIZER INC202101436639

Write-up: SARS-CoV-2 infection, other, Vaccination failure/ Variant PCR-based: Sequenced variant: n501y-positive: Unknown; SARS-CoV-2 infection, other, Vaccination failure/ Variant PCR-based: Sequenced variant: n501y-positive: Unknown; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050298. A 20-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 17Jul2021 (Batch/Lot Number: FD6840) as DOSE 2, SINGLE, dose 1 intramuscular on 12Jun2021 (Batch/Lot Number: FD1921) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection, other, Vaccination failure. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Sep2021 (Variant PCR-based: Sequenced variant: n501y-positive: Unknown). The outcomes of events were unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1850226 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-09-16
   Days after vaccination:83
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002920 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: Vaccination failure; SARS-CoV-2 infection; This case was received (Reference number: AT-BASGAGES-2021-050355) on 01-Nov-2021 and was forwarded to Moderna on 01-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) in a 34-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3004218 and 3002920) for COVID-19 vaccination. No Medical History information was reported. On 25-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant) and COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant). At the time of the report, VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) to be possibly related. No concomitant medication information was provided. No treatment medication information was provided. company''s comment: This case concerns a 34-year-old, male patient with no relevant medical history, who experienced the unexpected event of COVID-19 and vaccination failure. The events occurred approximately 1 month after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 34-year-old, male patient with no relevant medical history, who experienced the unexpected event of COVID-19 and vaccination failure. The events occurred approximately 1 month after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1851547 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-09-16
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2; Sequenced variant: n501y-positive: No
CDC Split Type: ATPFIZER INC202101438022

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-058786. An 85-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Lot Number: ET3620) intramuscular on 30Mar2021 (unknown age at time of vaccination) as single dose, the first dose of bnt162b2 (COMIRNATY, Lot Number: ET1831) intramuscular on 09Mar2021 (unknown age at time of vaccination) as single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced SARS-CoV-2 infection and vaccination failure on 16Sep2021. The events were assessed as serious with criteria of hospitalization. The patient underwent COVID-19 PCR test with result positive on 16Sep2021 (Variant PCR-based: B.1.617.2; Sequenced variant: n501y-positive: No). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1851641 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-09-16
   Days after vaccination:81
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive; Comments: Variant PCR-based: B.1.617.2, Sequenced variant, n501y-positive: No.
CDC Split Type: ATPFIZER INC202101436055

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number AT-BASGAGES-2021-050300. A 30-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 27Jun2021 (Batch/Lot Number: FD4555) as DOSE 2, SINGLE, dose 1 intramuscular on 23May2021 (Batch/Lot Number: FA4598) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure and sars-cov-2 infection on 16Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive (Variant PCR-based: B.1.617.2, Sequenced variant, n501y-positive: No) on 16Sep2021. The outcome of the events was unknown. No follow-up activities possible. No further information expected.


VAERS ID: 1851760 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004219 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Eye infection
SMQs:, Ocular infections (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Seasonal allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20213

Write-up: The day after the injection (09/16/2021), I woke with a red, sore eye. Diagnosis from the hospital ophthalmologist: corneal infection of the right eye.Treatment for two weeks with Flox...; This regulatory authority case was reported by a consumer and describes the occurrence of EYE INFECTION (The day after the injection (09/16/2021), I woke with a red, sore eye. Diagnosis from the hospital ophthalmologist: corneal infection of the right eye. Treatment for two weeks with Flox...) in a 29-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3004219) for COVID-19 vaccination. Concurrent medical conditions included Pollen allergy. On 15-Sep-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Sep-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced EYE INFECTION (The day after the injection (09/16/2021), I woke with a red, sore eye. Diagnosis from the hospital ophthalmologist: corneal infection of the right eye. Treatment for two weeks with Flox...) (seriousness criterion medically significant). At the time of the report, EYE INFECTION (The day after the injection (09/16/2021), I woke with a red, sore eye. Diagnosis from the hospital ophthalmologist: corneal infection of the right eye.Treatment for two weeks with Flox..) was resolving. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications was reported. Patient woke with a red, sore eye diagnosis from the hospital ophthalmologist: corneal infection of the right eye. Treatment for two weeks with Floxal (8x/day) and floxal ointment. (eng). Company comment: This case concerns a 29-year-old, male patient with no relevant medical history, who experienced the unexpected event of eye infection. The event eye infection occurred 1 day after the unknown dose number of Moderna Covid-19 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Translation document received on 03-Nov-2021 included translated events and sender''s comments.; Reporter''s Comments: The causality is considered possible due to the temporal correlation. The reaction is not listed (not labeled) in the Regulatory Authority Summary of Product Characteristics.; Sender''s Comments: This case concerns a 29-year-old, male patient with no relevant medical history, who experienced the unexpected event of eye infection. The event eye infection occurred 1 day after the unknown dose number of Moderna Covid-19 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.


VAERS ID: 1851766 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination site reaction
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101442959

Write-up: Injection site reaction; This is a spontaneous report from a contactable consumer. This is a report received from Swissmedic, the Swiss regulatory authority. Regulatory authority report number CH-SM-2021-27304. This case was split to capture events after first and second dose of vaccine. This is the first of two reports, describing events after first dose. A 38-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number was not reported), via an unspecified route of administration on 15Sep2021 as DOSE 1, SINGLE (at the age of 38-year-old) for covid-19 immunisation. Medical history included seasonal allergy from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 16Sep2021, the patient experienced injection site reaction. This case was reported as serious (other medically important condition). Outcome of the event was recovering. Sender comment: The causality relationship between Comirnaty and injection site reaction was assessed as being possible. No follow-up attempts possible, batch/lot number cannot be obtained. No further information expected.; Sender''s Comments: Linked Report(s) : 202101463347 1st/2nd dose, same vaccine, same patient, different events.


VAERS ID: 1852068 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-09-16
   Days after vaccination:188
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PERINDOPRIL/INDAPAMIDE; METFORMIN;VILDAGLIPTIN; METOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Hypertension; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210922; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC202101436077

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB EE-SAM-53612110044. A 75-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 12Mar2021 (Batch/Lot Number: ER2659; Expiration Date: 30Jun2021) as DOSE 2, 0.3 mL, single, dose 1 intramuscular on 19Feb2021 (Batch/Lot Number: EJ6789; Expiration Date: 31May2021) as DOSE 1, 0.3 mL, single for covid-19 immunisation. Medical history included atrial fibrillation, hypertension, type 2 diabetes mellitus, all from an unknown date and unknown if ongoing. Concomitant medication included indapamide, perindopril erbumine (PERINDOPRIL/INDAPAMIDE) taken for an unspecified indication, start and stop date were not reported; metformin;vildagliptin (METFORMIN;VILDAGLIPTIN) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported. Patient experienced vaccination failure after vaccination with COVID-19 mRNA vaccine. On 16Sep2021, the patient developed COVID symptomatic infection. SARS-CoV-2 PCR test was positive on 22Sep2021. The patient had bilateral pneumonia, fever, cough, she was hospitalized by ambulance. The course of the disease was moderate, the patient required supplemental oxygen with a reservoir mask. She became infected while in a sanatorium (pending clarification). The patient recovered and was discharged home on 04Oct2021. Sender Comment: Serious vaccine ineffectiveness report. The causal relationship is considered possible. Conclusion: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5732035 and Reference PR ID 5856224 (see File attachment in this investigation record). The complaint for LOE/adverse event of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6789 and ER2659. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause were identified as the complaint was not confirmed.


VAERS ID: 1852278 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Generalised tonic-clonic seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC202101436688

Write-up: Grand mal epileptic fit; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-MA20214268. A 27-year-old male patient received the first dose of bnt162b2 (COMIRNATY), intramuscular at the age of 27-year-old on 15Sep2021 (Lot Number: FG4493) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced grand mal epileptic fit on 16Sep2021 with outcome of recovered. It is reported the patient experienced on day 1 a tonic-clonic generalised grand mal seizure, regressive and without recurrence. Electroencephalography and brain scan pending. The patient underwent lab tests and procedures which included blood test: normal on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1852348 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-28
Onset:2021-09-16
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Immune thrombocytopenia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Vertigo
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Immune thrombocytopenic purpura; This case was received via the RA (Reference number: FR-AFSSAPS-PO20215311) on 29-Oct-2021 and was forwarded to Moderna on 29-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura) in a 96-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Vertigo. Concurrent medical conditions included Hypertension arterial and Asthma. On 28-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 16-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura) (seriousness criteria hospitalization and medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura) was resolving. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. Rechallenge was done, Immune thrombocytopenic purpura recurred No treatment information was provided. Company Comment: This is a regulatory case concerning a 96 year-old, mfeale patient with no relevant history, who experienced the unexpected serious event of IMMUNE THROMBOCYTOPENIA . The event occurred approximately 20 days after a dose of mRNA-1273 Moderna vaccine (RA doesn?t clarify if it was 1st or 2nd). The rechallenge was positive (as per RA). The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Translation received on 01 Nov 2021 include no new information; Sender''s Comments: This is a regulatory case concerning a 96 year-old, mfeale patient with no relevant history, who experienced the unexpected serious event of IMMUNE THROMBOCYTOPENIA . The event occurred approximately 20 days after a dose of mRNA-1273 Moderna vaccine (SD doesn?t clarify if it was 1st or 2nd). The rechallenge was positive (as per SD). The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.


VAERS ID: 1852580 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-09-16
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amenorrhoea, Pregnancy test
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: Pregnancy test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101449662

Write-up: Absence of menstruation/Missed period - regular cycle lengths of 28days. Now on day 45 and no period and no sign of period; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110260728200320-CZHQB, Safety Report Unique Identifier GB-MHRA-ADR 26121298. A female patient of an unspecified age received BNT162B2 (COMIRNATY), via an unspecified route of administration on 23Aug2021 as dose 1, single for COVID-19 immunization. Medical history included none. There were no concomitant medications. The patient experienced absence of menstruation (disability) on 16Sep2021 with outcome of not recovered. The patient underwent lab tests and procedures which included pregnancy test: negative on an unspecified date. Additional information: None. No medications from the list either. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. The clinical course was reported as follows: Missed period - regular cycle lengths of 28days. Now on day 45 and no period and no sign of period. Now she cannot undergo IVF treatment, hence why selected it was caused a significant or long term impact. As we now have no idea when we may possibly be able to undergo IVF again. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1852780 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-09-16
   Days after vaccination:138
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Headache, Myalgia, Pyrexia, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRASTUZUMAB
Current Illness: Mastectomy
Preexisting Conditions: Medical History/Concurrent Conditions: Breast tumour malignant
Allergies:
Diagnostic Lab Data: Test Date: 20211006; Test Name: SARS-CoV-2 molecular test negative; Result Unstructured Data: Test Result: negative; Test Date: 20210918; Test Name: SARS-CoV-2 molecular test positive; Result Unstructured Data: Test Result: positive.
CDC Split Type: ITPFIZER INC202101437133

Write-up: vaccination failure; covid-19; Myalgia; Fever; Headache; This is a spontaneous report from a contactable pharmacist from the Regulatory Authority. The regulatory authority number IT-MINISAL02-800913. A 54-years-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: EX7389; Expiration Date: 31Aug2021) via intramuscular, administered in Deltoid Right on 01May2021 09:44 as dose 2, single and first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: EW2246; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in Deltoid Right on 10Apr2021 16:50 as dose 1, single and for COVID-19 immunization. Medical history included Breast tumour malignant (unknown if ongoing), in relation to breast cancer, the patient underwent surgery from 10May2021 to 10May2021, she is receiving maintenance therapy with Trastuzumab every 21 days. Concomitant medication included TRASTUZUMAB taken for breast cancer. On 16Sep2021, the patient experienced myalgia, fever, and headache. On 18Sep2021, the patient experienced vaccination failure and covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 06Oct2021, sars-cov-2 test positive on 18Sep2021. Therapeutic measures were taken as a result of covid-19 using 2400mg (1200 + 1200mg) casirivimab + imdevimab. The outcome of the events covid-19 was unknown while other events was recovered on 09Oct2021. Booster dose number (1) on 10Apr2021, time of administration (04:50pm), batch EW2246, right deltoid. On 19Oct2021, through telephone contact, the patient''s husband re-ported - concomitant pathologies/drugs of the patient - in relation to breast cancer the patient underwent surgery on 10May2021, and currently she is receiving maintenance therapy with Trastuzumab every 21 days. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EW2246 and EX7389. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root causes were identified as the complaint was not confirmed. This is a spontaneous follow-up report from product quality complaint team regarding consumer''s complaint about bnt162b2 (COMIRNATY) lot: EW2246 and EX7389, expiration date: 31Jul2021 and 31Aug2021).


VAERS ID: 1852849 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Body temperature, Chest pain, Disease recurrence, Pain, Palpitations, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris (Several years ago, the patient was suspected of angina pectoris.); Eye allergy (Eyes react to cedar pollen); Physical deconditioning (1st vaccination was carried out under the bad health condition caused by summer tiredness.); Pollen allergy (Eyes react to cedar pollen); Sleeplessness; Stress (1st vaccination was carried out may be caused by stress coming from suspension from office.)
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:close to 39.0 Centigrade
CDC Split Type: JPPFIZER INC202101432388

Write-up: Spasmodic angina/Cardiac symptoms; palpitations; chest pain; pyrexia close to 39.0 degrees centigrade; On 21Sep2021 (5 days after the vaccination), the patient experienced Spasmodic angina.; pantalgia; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. Regulatory authority report number is v21129903. A 52-year and 8-month-old male patient received BNT162B2 (COMIRANTY; Solution for injection; Lot number and Expiration date unknown), via an unspecified route of administration on 16Sep2021 (the day of vaccination), (Age at vaccination: 52-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included angina pectoris (Several years ago, the patient was suspected of angina pectoris), seasonal allergy (Eyes react to cedar pollen), eye allergy (Eyes react to cedar pollen), insomnia (Insomnia) (the patient claimed for sleeplessness), physical deconditioning (The 1st vaccination was carried out under the bad health condition caused by summer tiredness and also may be caused by stress coming from suspension from office) and stress from an unknown date and unknown if ongoing. Concomitant medication was not reported. The patient previously took solanax (0.4 mg). Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status). Historical vaccine included: first dose of BNT162B2 (COMIRANTY; Solution for injection) as dose 1, single on 02Oct2021 for COVID-19 immunization and experienced pyrexia (pyrexia of 38.3 degrees centigrade for one day). On 21Sep2021 (5 days after the vaccination), the patient experienced Spasmodic angina. The course of the event was as follows: after vaccination on 16Sep2021, the patient experienced pyrexia close to 39.0 degrees centigrade and pantalgia. On 21Sep2021, palpitations and chest pain occurred. The patient left from work and consulted [PRIVACY] Hospital. The patient was prescribed NICORANDIL and nitrobenzene. The symptoms disappeared and the patient stopped taking drugs after several days. The patient received the second vaccination on 02Oct2021, the patient experienced pyrexia of 38.3 degrees centigrade and only last for one day. The reporting pharmacist commented as follows: The 1st vaccination was carried out under the bad health condition caused by summer tiredness. Cardiac symptoms may be caused by stress coming from suspension from office. The reporter advised the patient to stay well and healthy on the 3rd day. The patient underwent lab tests and procedures which included body temperature: close to 39.0 centigrade on 16Sep2021 and body temperature: 38.3 centigrade on 02Oct2021 after 2nd dose. On 28Sep2021 (12 days after the vaccination), the outcome of the event was recovered. The reporting pharmacist classified the event as non-serious and assessed that the event was related to bnt162b2. Other possible causes of the event such as any other diseases was that the patient was busy and he was lack in sleep. The patient''s water intake is also low. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101450672 same reporter/patient/product, different dose/event


VAERS ID: 1852939 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-09-16
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Placental infarction
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101437717

Write-up: Maternal exposure during pregnancy; Placenta was already ''on'' too early: there was an infarction in it; This is first of two reports. A contactable consumer (patient) reporting similar event for different vaccine doses for same patient. The report is for second dose. This is a spontaneous report downloaded from the Regulatory Authority-WEB NL-LRB-00700297 Sender''s (Case) Safety Report Unique Identifier NL-LRB-00703550, NL-LRB-00702924 A 31-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 17Aug2021 (Batch/Lot Number: Unknown) at the age of 31-years-old as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included maternal vaccine exposure. No Previous COVID-19 infection. The patient''s concomitant medications were not reported. The Historical Vaccine included Comirnaty (1st dose, 0.3ml) on 12Jul2021 for Covid-19 immunisation and experienced maternal exposure during pregnancy. The patient experienced maternal exposure during pregnancy on an unspecified date with outcome of unknown, placenta was already ''on'' too early: there was an infarction in it on 16Sep2021 with outcome of unknown. The events were serious due to medically significant. The patient was vaccinated at a pregnancy duration of 33 weeks. It was her second Covid vaccination. After delivery the placenta looked like it was 42 weeks old in stead of 37 weeks. The patient is not aware of being infected with corona during pregnancy. Her child was born healthy. The event outcome was unknown. Sender Comment: This reaction was considered serious (seriousness ''other'') by assessor . Case summery and Reporters comment text: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 12Jul2021 Placenta was ''on'' too early Additional information ADR: Placenta at 37 weeks looked like placenta at 42 weeks (white instead of red) and contained an infarct BSN available: yes confounding factors vaccine exposure during pregnancy week: 33 COVID-19- Previous COVID-19 infection: No. As far as I know I haven''t had corona. The midwife said she seemed to see a pattern in vaccinated pregnant women and their placentas after delivery. So she''s been seeing this more often lately. Luckily my baby is completely healthy! No follow-up attempts possible. No further information expected.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 12Jul2021. Placenta was ''on'' too early. Additional information ADR: Placenta at 37 weeks looked like placenta at 42 weeks (white instead of red) and contained an infarct. BSN available: yes. confounding factors vaccine exposure during pregnancy week: 33. COVID-19- Previous COVID-19 infection: No. As far as I know I haven''t had corona. The midwife said she seemed to see a pattern in vaccinated pregnant women and their placentas after delivery. So she''s been seeing this more often lately. Luckily my baby is completely healthy!; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101465711 same patient different doses&different events


VAERS ID: 1852941 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram coronary artery, Electrocardiogram, Electroencephalogram, Magnetic resonance imaging head, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TAMOXIFEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Normal; Test Name: EEG; Result Unstructured Data: No epilepsy; Test Name: MRI brain; Result Unstructured Data: No particulars; Test Name: Coronary calcium scan; Result Unstructured Data: Normal with heart and veins
CDC Split Type: NLJNJFOC20211107617

Write-up: FEELING UNWELL, LOST CONSCIOUSNESS FOR 15 MINUTES, LOSS OF BLADDER CONTROL, VOMITED IN UNCONSCIOUS CONDITION.; This spontaneous report received from a consumer via a Regulatory Authority [regulatory authority, NL-LRB-00700845] concerned a 54 year old female. The patient''s weight was 69 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD975 expiry: UNKNOWN) 0.5 ml, 1 dosage forms, 1 total administered on 28-MAY-2021 for covid-19 immunisation. The drug start period was 15 minutes. Concomitant medications included tamoxifen. On 16-SEP-2021, the patient experienced feeling unwell, lost consciousness for 15 minutes, loss of bladder control, vomited in unconscious condition. Laboratory data (dates unspecified) included: Coronary calcium scan (NR: not provided) Normal with heart and veins, ECG (NR: not provided) Normal, EEG (NR: not provided) no epilepsy, and MRI brain (NR: not provided) No particulars. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling unwell, lost consciousness for 15 minutes, loss of bladder control, vomited in unconscious condition. This report was serious (Other Medically Important Condition).


VAERS ID: 1852969 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness exertional, Exertional headache, Heart rate, Heart rate increased, Malaise, Nausea, Oropharyngeal pain
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: OMEGA 3 [FISH OIL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: Pulse rate; Result Unstructured Data: Test Result:small increase
CDC Split Type: NOPFIZER INC202101438035

Write-up: Sore throat when in activity; Nausea when in activity; Dizziness exertional; exertional headache; got sick the night after vaccination; With a small increase in pulse rate; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority WEB NO-NOMAADVRE-PASRAPP-2021-Uw72d3. A 17-year-old male patient received second dose of BNT162B2(COMIRNATY, Batch/Lot Number: Unknown), intramuscular administered in arm left on 14Sep2021 23:00 at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included Vitamin bears and fish oil (OMEGA 3). The patient reports being an active cross country skier and has not attended work outs the past 5 weeks. The patient developed exertional headache on 16Sep2021, dizziness exertional on 16Sep2021, sore throat when in activity on 16Sep2021, nausea when in activity on 16Sep2021. The patient reported got feeling sick the night after vaccination on 16Sep2021. The patient reports that tomorrow (the day after the reporting time) it passes 5 weeks of dizziness exertional, nausea when in activity, exertional headache and sore throat when in activity with every small movement. With a small increase in pulse rate all four symptoms are provoked on 16Sep2021. As long as the patient is resting it is going fine in the whole. The patient reports latency of exertional headache, dizziness exertional, sore throat when in activity, and nausea when in activity to be the night after vaccination. The reactions was considered to be serious due to (Hospitalization Required). Contact with healthcare professionals Physician. The outcome of event got sick the night after vaccination and with a small increase in pulse rate was unknown and other events was not recovered. Reporter''s comments: Contact with healthcare professionals: Physician. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Contact with healthcare professionals: Physician.


VAERS ID: 1854968 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-09-16
   Days after vaccination:223
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: n501y-positive: unknown
CDC Split Type: ATPFIZER INC202101461921

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA) -WEB, Regulatory Authority number AT-BASGAGES-2021-050455. A 31-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: EJ6797), via intramuscular, on 12Jan2021 at single dose and the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: EJ6796), via intramuscular, on 05Feb2021 at single dose, both for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 16Sep2021 the patient experienced SARS-CoV-2 infection, other, Vaccination failure. On 16Sep2021, COVID-19 PCR test resulted positive (n501y-positive: unknown). The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.


VAERS ID: 1854985 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-09-16
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC202101455680

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-050691. A 56-year-old female patient received BNT162B2 (COMIRNATY) via intramuscular, as a single dose, on 09Jul2021 as second dose (lot number FD0168), on 04Jun2021 as first dose (lot number FC2473), for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection/ vaccination failure. The patient underwent lab data on16Sep2021 which included COVID-19 PCR test with positive result. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1855216 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Chest pain, Dyspnoea, Heart rate, Heart rate increased, Nausea, Presyncope, Syncope, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: heart rate; Result Unstructured Data: Test Result:increased
CDC Split Type: AUPFIZER INC202101458339

Write-up: Syncope; Anxiety; Chest pain; Dyspnoea; Heart rate increased; Nausea; Presyncope; Wheezing; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. The regulatory authority report number is 649135. A 37-year-old male patient received BNT162B2 (COMIRNATY) at single dose on an unspecified date for covid-19 immunisation. Medical history and concomitant medications were not reported. On 16Sep2021, the patient experienced syncope, anxiety, chest pain, dyspnoea, heart rate increased, nausea, presyncope and wheezing. The outcome of events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1857229 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-09-16
   Days after vaccination:58
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Investigation, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: n501y-positive; Result Unstructured Data: Test Result:No; Test Date: 20210916; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive; Test Name: Variant PCR-based; Result Unstructured Data: Test Result:B.1.617.2
CDC Split Type: ATPFIZER INC202101462648

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050325. A 17-years-old male patient received bnt162b2 (COMIRNATY, formulation: solution for injection, lot number was FF0680 and expiration date was not reported), dose 2 intramuscular on 20Jul2021 as dose 2, single and dose 1 via intramuscular on 15Jun2021 (lot number was FD1921 and expiration date was not reported) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 16Sep2021 the patient experienced vaccination failure and sars-cov-2 infection. The patient underwent lab tests and procedures which included investigation with no result on unspecified date, sars-cov-2 test with result positive on 16Sep2021, sars-cov-2 test with result b.1.617.2 on unspecified date. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1857292 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-09-16
   Days after vaccination:157
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101461952

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050474. A 59-years-old male patient received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: ET1831), via intramuscular route of administration on 12Apr2021 as DOSE 2, SINGLE and first dose via intramuscular route of administration on 15Mar2021 (Batch/Lot Number: ET1831) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was not reported. The concomitant medications were none. On 16Sep2021, the patient experienced SARS-CoV-2 infection and vaccination failure. On 16Sep2021, the patient underwent lab tests and procedures which included sars-cov-2 test shown positive, Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1857293 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-09-16
   Days after vaccination:178
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617 not differentiated Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101461901

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency European Medicines-WEB, regulatory authority number AT-BASGAGES-2021-050475. A 89-year-old male patient received bnt162b2 (COMIRNATY,Solution for injection), dose 2 intramuscular on 22Mar2021 (Batch/Lot Number: ET3620) as DOSE 2, SINGLE and received bnt162b2 (COMIRNATY,Solution for injection), dose 1 intramuscular on 01Mar2021 (Batch/Lot Number: EP2163) as DOSE 1, SINGLE for COVID-19 immunization .The patient medical history and concomitant medications were not reported.The patient experienced vaccination failure, sars-cov-2 infection on 16Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive(Variant PCR-based: B.1.617 not differentiated, Sequenced variant: n501y-positive:no on 16Sep2021. The clinical outcome of sars-cov-2 infection was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1857295 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-09-16
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101461964

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050478. A 51-year-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FD6840, Expiry date: unknown), via an Intramuscular route of administration on 14Jul2021, as DOSE 2, SINGLE and first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FD1921, Expiry date: unknown), via an intramuscular route of administration on 10Jun2021, as DOSE 1, SINGLE for COVID-19 immunization. The patient had no medical history and concurrent conditions. No concomitant medication reported. On 16Sep2021, the patient experienced sars-cov-2 infection. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Sep2021 Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No. The outcome of event was unknown at the time of this reported. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1858719 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pericardial effusion
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101452458

Write-up: Pericardial effusion; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 646461. A female patient of an unspecified age (Age: 53, Unit; Not specified) received BNT162B2 (COMIRNATY, 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''s medical history and concomitant medications was not reported. On 16Sep2021, the patient experienced pericardial effusion. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1699852 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Body temperature increased, Burning sensation, Chills
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline, immunity support
Current Illness: None
Preexisting Conditions: None
Allergies: Ingrezza, risperdal
Diagnostic Lab Data:
CDC Split Type:

Write-up: 9 hours late, woke up with intense chills, temp that got up to 103, eventually turned in feeling of body on fire


VAERS ID: 1699875 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 3183 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Nausea, Pyrexia, Skin warm, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Similar to current symptoms, much more mild. 19 years old. Reaction to first Covid 19 dose.
Other Medications: birth control zyxol
Current Illness: no
Preexisting Conditions: n/a
Allergies: seasonal
Diagnostic Lab Data:
CDC Split Type:

Write-up: fever of 103, shaking, chills, uncontrollable nausea, hot skin.


VAERS ID: 1700063 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Amenorrhoea, Anxiety, Breast tenderness, Confusional state, Depression, Dizziness, Dysmenorrhoea, Dyspnoea, Fatigue, Feeling cold, Heart rate increased, Heavy menstrual bleeding, Hot flush, Insomnia, Mood swings, Rash
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Fertility disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: flu shot - extrememly sick had to go to hospital
Other Medications: singular proair
Current Illness: none
Preexisting Conditions: after I got the vaccine I am having female issues ( extremely long periods/anxiety/depression...), light headedness and confusion . I also had breathing issues, fast heartbeat slight rash was extremely tired but couldnt sleep thru night for the first couple weeks after the shot but that has gone back to normal. Pharmacy told me these were normal symptons and if didnt go away to go to my doctor which is what I did. My doctor has put me on medicine to help with the female issues.
Allergies: bioxin eggs poultry & bees slight allergy to latex and dairy
Diagnostic Lab Data: Pharmacy said normal symptons and if doesnt go away to talk to my doctor He put me on medication and also did blood test. I was pre-diabetic and now I am type 2 diabetic.
CDC Split Type:

Write-up: put this in previous spot......rash fast heartbeat light headedness confusion, went from almost no periods to long painful periods, tender breasts, breathing issues, depression, anxiety, mood swings, hot/cold flashes,


VAERS ID: 1700110 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 049E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Dizziness, Nausea, Pain, Pain in extremity, Tinnitus, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tri-Lo-Mili birth control, Dextroamp-Amphet ER 30 MG,
Current Illness: Non
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: My entire left arm started to throb at 1:00am. I then started to get nauseous and vomited. After I vomited I was walking to the couch and started to feel very light headed and my knees were starting to buckle and my ears were ringing. I felt like I was going to pass out. I laid down and went to sleep. When I woke up at 7:00 am my entire left arm was sore all the way to my wrist and the soreness was going to my shoulder down my left side all the way down to my thighs. My entire left side is sore. I am also having stomach cramps.


VAERS ID: 1700134 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6200 / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: multi-vitamin, vitamin E
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: I was on a backpacking hike on the AT and had a great hike the evening before the event. The next morning, I couldn''t hike more than 5 steps up all the gentle inclines & had to stop & try to catch my breath. This happened throughout the morning until I was able to get off trail. I am a former ultra marathon runner & long distance hiker. I''ve hiked the trails at high altitude & snowy passes without ever having an issue such as this one. The next day, I was able to continue unimpeded. A very strange occurrence. I''m late in reporting this, as I originally didn''t attribute this to the vaccine, but now feel this may be the contributing factor.


VAERS ID: 1700187 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blindness, Dizziness, Immediate post-injection reaction, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Covid 19 first dose, disclosed swelling of throat with dose 1 after the second dose was given and reaction started
Other Medications: None
Current Illness: None reported
Preexisting Conditions: None reported
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Reaction including dizziness, vomiting, loss of vision immediately after vaccine. Called EMS and sent to local hospital.


VAERS ID: 1700189 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Interchange of vaccine products
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Dose of Pfizer given mistakenly in a patient whose first dose was with Moderna (5/7/21). Instructed patient to not pursue any additional doses of mRNA vaccine unless he meets indication for 3rd dose.


VAERS ID: 1700198 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Tinnitus
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atorvastatin, EC ASA, niacin, vit c , vit d3, zinc
Current Illness: N/A
Preexisting Conditions: hypercholesterolemia
Allergies: thimerosal
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: tinnitus


VAERS ID: 1700214 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 062E21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Headache
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: migraines
Allergies: Diclofenac, Iodine
Diagnostic Lab Data:
CDC Split Type:

Write-up: 1007a c/o headache, lightheaded, BP 143/89 P 80 1022a BP 134/78 P 75 1024a placed in recliner 1033a Bp 142/87 P 74 pt reports feels like this when he gets a migraine 1035a ambulated to Exit with (Security)


VAERS ID: 1700231 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Musculoskeletal chest pain, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Ibuprofen
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: I was fine the same night, my arm was getting sore. But about an hour after I woke up, my left side below the ribs started getting extreme pain. It still hurts after 3 hours, it?s knocked me to my knees a few times. I took tylonel an hour ago and it hasn?t helped at all.


VAERS ID: 1700268 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-31
Onset:2021-09-15
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: Penicillins
Diagnostic Lab Data: none yet, referred her to PCP
CDC Split Type:

Write-up: Painful, swollen left arm


VAERS ID: 1700272 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Maine  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dyspnoea, Palpitations, Tinnitus
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Diazepam, levothyroxine, baclofen, Hydroxyzine
Current Illness:
Preexisting Conditions: Graves disease, Fibromyalgia, Hepatitis C (treated)
Allergies: bactrim
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Ringing ears within 10 minutes after vaccine given and lasting an hour. Started feeling out of breath at 11:30 am 9/15/21 and like my heart is racing.


VAERS ID: 1700273 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-08-31
Onset:2021-09-15
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1820095 / UNK LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Chills, Feeling abnormal, Headache, Hypoaesthesia, Nausea, Pain, Pyrexia, Tremor
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: low back pain
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Extreme body pain, shaking, chills, fever, nausea, headache, numb legs and a feeling that something is "off"


VAERS ID: 1700278 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dysphagia, Nausea, Pharyngeal swelling, Tachycardia, Tremor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt c/o feeling like "throat swelling" and difficult to swallow approx 5 min after receiving vaccine. Also c/o nausea, tachycardia and shaking.


VAERS ID: 1700302 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037F21A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Patient received first Moderna COVID Vaccine on 8/30/2021, Patient received 2nd dose today 9/15/2021 earlier than the recommended 28 day interval for COVID vaccine.
Current Illness: None.
Preexisting Conditions: COVID-19 4/2021.
Allergies: NKDA/NKA.
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: No adverse event occurred, patient observed for 30 minutes. Patient received Moderna Covid-19 vaccine 2nd dose on day # 16 instead of recommended date of day #28


VAERS ID: 1700361 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Interchange of vaccine products
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was given Pfizer for the second dose, instead of Moderna.


VAERS ID: 1700384 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Vertigo
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Dizziness and Vertigo. Began upon waking and has continued throughout the day.


VAERS ID: 1700403 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cyst, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin tumeric
Current Illness:
Preexisting Conditions: DM
Allergies: Sulfa, Green and red peppers
Diagnostic Lab Data: N/a
CDC Split Type:

Write-up: I woke to pain in hands. I have cysts on right hand to third and fourth fingers on palm to left hand and on on right hand4th finger palm. Left arm pain.-


VAERS ID: 1700419 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-13
Onset:2021-09-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 049E21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Axillary mass, Axillary pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: One day after the shot a developed a large lump in my left arm bit. The lump was painful. It still has not subsided. I contacted the pharmacy and they knew not of any side affects regarding lumps in the arm pits. I subsequently looked online and read a article talking about swollen lymph nodes. I can?t believe that the people who are given the responsibility of injecting this poison into peoples bodies don?t know the current side affects or have any treatment options other then call your doctor.


VAERS ID: 1700422 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011F21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Vaccine positive rechallenge
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 31, MODERNA, 8/13/21
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: CEFZIL
Diagnostic Lab Data:
CDC Split Type:

Write-up: AFTER ADMINISTERING THE INJECTION I IMMEDIATELY SAW A RAISED AREA ABOUT THE SIZE OF A QUARTER WHERE THE INJECTION WAS GIVEN. THE PATIENT STATED THAT HIS ARM WAS NUMB IN THE INJECTION ARM. HOWEVER, HE STATED THAT THIS HAD OCCURED WITH THE FIRST VACCINE AND IT LASTED TWO DAYS.


VAERS ID: 1700448 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hyperhidrosis, Memory impairment, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine 25 mcg 1/day Lovastatin 40 mg 1.5/day Zetia 10 mg 1/day Letrozole 2.5 mg 1/day Losartan 25 mg 1/day Aspirin (costed) 81 mg 1/day Calcium 600 mg 2/day Vitamin D3 2000 IU 1/day
Current Illness: none
Preexisting Conditions: Had bypass surgery in 2012. Being treated Breast Cancer since Dec 2017. Generally healthy.
Allergies: Lipitor causes skin rash
Diagnostic Lab Data: none, so far.
CDC Split Type:

Write-up: Fainted at 7:45am on 9/15/2021. She lost total control. I (husband) happened to be near by and held her. After 45-60 seconds I took her to sofa and she lied down for about 10-15 mins. During the time she was sweating a lot. After that no issues so far. She does not remember 45-60 second period at all.


VAERS ID: 1700517 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-09-13
Onset:2021-09-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301308A / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Blood test, Electrocardiogram, Palpitations, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pred-Forte ophthalmologic use
Current Illness: NA
Preexisting Conditions: Asthma
Allergies: Penicillin
Diagnostic Lab Data: EKG, blood tests performed. Awaiting results of blood tests.
CDC Split Type:

Write-up: Less than 48 hrs post vaccination, patient awoke at 1AM with heart racing at 188bpm for 10 minutes, then continued to have tachycardia or arrhythmia event for 1 hr. Patient visited her healthcare provider the morning after to report event and to be evaluated.


VAERS ID: 1700579 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0167 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Lip swelling, Tachycardia, Throat irritation
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: adderal 15 mg daily, nuva ring, (BCP)
Current Illness: none
Preexisting Conditions: palpitation when 4-8 yo. saw physician and was told to stop caffeine. resolved since a child.
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Awoke with swollen upper lip and is having intermittent tachycardia to the 130''s at rest. Has taken Benadryl. Lip looks a little better now at 2:25 PM than this AM. Slightly scratchy throat. Has no allergies to meds, foods etc.


VAERS ID: 1700597 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8839 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Chest discomfort, Feeling cold
SMQs:, Anaphylactic reaction (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLONAZEPAM, 0.5 mg
Current Illness: None
Preexisting Conditions: None
Allergies: Tylenol 3
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Anxiety, cold feeling on chest.


VAERS ID: 1700602 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 014F21A / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Eye swelling, Eyelid oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: na
Preexisting Conditions: unknown
Allergies: nka
Diagnostic Lab Data: NONE; PATIENT WENT TO PCP TO BE SEEN AND TREATED.
CDC Split Type:

Write-up: SWELLING TO LEFT EYE LID AND LOWER LID INCLUDING A POCKET OF FLUID UNDER THE LEFT EYE.


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